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

+ + + + + CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

OZONE REVIEW PANEL

+ + + + +

PUBLIC MEETING

+ + + + + MONDAY, JANUARY 9, 2012

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

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

ANA DIEZ-ROUX H. CHRISTOPHER FREY ARMISTEAD (TED) RUSSELL HELEN SUH KATHLEEN WEATHERS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 2 PANEL MEMBERS PRESENT: MICHELLE BELL JOSEPH D. BRAIN DAVID CHOCK WILLIAM MICHAEL FOSTER JUDITH GRAHAM DAVID GRANTZ JACK HARKEMA DANIEL JACOB STEVEN KLEEBERGER FREDERICK J. MILLER HOWARD NEUFELD JAMES ULTMAN SVERRE VEDAL

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF PRESENT: AARON YEOW, Designated Federal Officer VANESSA VU, Director, SAB Staff Office

JAMES BROWN, ORD/NCEA BRYAN HUBBELL, OAQPS SCOTT JENKINS, OAQPS KAREN MARTIN, OAQPS TRAVIS SMITH, OAQPS JOHN J. VANDENBERG, ORD/NCEA LYDIA WEGMAN, OAQPS KAREN WESSON, OAQPS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 3 C-O-N-T-E-N-T-S Page Convene Meeting by Aaron Yeow, DFO 6

Welcome by Dr. Vanessa Vu 8

Introductions 11 Review of Agenda by Dr. Jonathan Samet 14

EPA Presentation on Revisions to the Draft Ozone Integrated Science Assessment 16 Dr. John Vandenberg Dr. James Brown Update on the Risk and Exposure Assessment and the Policy Assessment 40 Ms. Lydia Wegman Karen Wesson Dr. Bryan Hubbell Dr. Scott Jenkins Dr. Karen Martin

Public Comments George Wolff Air Improvement Resources, Inc. 89 G. Bruce Copley ExxonMobil Biomedical Sciences, Inc. 94 Neeraja Erraguntla Texas Commission on Environmental Quality 104 Roger McClellan Toxicology and Human Health Risk Analysis 110

### 202-234-4433 Neal R. Gross & Co., Inc. Page 4 C-O-N-T-E-N-T-S (Cont'd) Page Deborah Shprentz American Lung Association 118

William McDonnell William F. McDonnell Consulting 123 Christopher Emery ENVIRON International Corporation 140 Richard Smith University of North Carolina 147 Mark Nicolich COGIMET 154 Nicole Downey Earth System Sciences, LLC 158

Julie Goodman Gradient 167 Sonya Sax Gradient 170 Doug Blewitt Air Quality Resource Management 173

John Jansen Southern Company 179 Samuel Oltmans University of Colorado Boulder 186

Allen Lefohn A.S.L. & Associates 193 Milan Hazucha University of North Carolina Chapel Hill 200 Discussion of EPA Charge Questions 208

### 202-234-4433 Neal R. Gross & Co., Inc. Page 5 C-O-N-T-E-N-T-S (Cont'd) Page Atmospheric Chemistry and Ambient Concentrations (Chapter 3) 215

Exposure to Ambient Ozone (Chapter 4) 258

Dosimetry and Mode of Action (Chapter 5) 270 Integrated Health Effects - Short-Term and Long-Term (Chapters 6 & 7) 305 At Risk Populations (Chapter 8) 362

Ozone Effects on Vegetation and Ecosystems (Chapter 9) 387

Role of Tropospheric Ozone in Climate Change (Chapter 10) 402

Preface, Preamble, Executive Summary (Chapter 1) 409 and Integrative Overview (Chapter 2) 418

Adjournment 459

### 202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 P-R-O-C-E-E-D-I-N-G-S

2 8:30 a.m. 3 MR. YEOW: Good morning. I'm 4 Aaron Yeow, the Designated Federal Officer for 5 this public meeting of the Clean Air 6 Scientific Advisory Committee Ozone Review

7 Panel. 8 I'd like to convene and open this 9 public meeting with a short statement. The 10 panel is meeting today and tomorrow to conduct 11 a peer review of EPA's second draft integrated 12 science assessment for ozone. 13 CASAC is a federal advisory 14 committee and by EPA policy its meetings and 15 deliberations are held as public meetings that 16 meet the requirements of the Federal Advisory 17 Committee Act, also known as FACA. 18 Through the charter CASAC, the 19 panel is empowered by law to provide advice to 20 the administrator. Consistent with the 21 requirements of FACA and with EPA policy, the 22 deliberations of the panel are conducted in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 7 1 public at meetings for which advance public 2 notice is given. 3 The discussions and substantive 4 deliberations of the panel, its interactions 5 with the public and the agency are conducted 6 in sessions where I, as the DFO, am present to 7 ensure that the requirements of FACA are met. 8 This includes the requirements for 9 open meetings, for maintaining records of 10 deliberations of the panel, making available 11 to the public summaries of meetings and 12 providing opportunities for public comment. 13 We have received several written 14 public comments which are available on our 15 website, and we have 16 registered public 16 speakers for today. Copies of their 17 presentations and/or their oral statements are 18 also posted on our website. 19 Minutes of this meeting are being 20 taken to summarize discussions and action 21 items in accordance with requirements under 22 FACA. These minutes will be certified by the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 8 1 Chair once completed. 2 I want to remind all in attendance 3 of the status of this panel's compliance with 4 federal ethics laws. The SAB Staff Office has 5 determined that there are no issues with 6 conflict of interest or appearance of a lack 7 of impartiality for any of the advisory panel 8 members participating in this review.

9 I also want to note that Dr. John 10 Bailar will be on the phone and Dr. Ted 11 Russell will be a little late this morning. 12 I would now like to turn the 13 meeting over to Dr. Vanessa Vu, Director of 14 the SAB Staff Office, and then over to Dr. Jon 15 Samet, Chair of the CASAC. 16 DR. VU: Thank you, Aaron. Good 17 morning, everyone. I'm Vanessa Vu. I'm the 18 Director of EPA's Science Advisory Board. I'd 19 like to welcome everybody to the meeting of 20 the Clean Air Scientific Advisory Committee 21 Ozone Review Panel. 22 The purpose of this meeting is for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 9 1 the panel to discuss and deliberate the, to 2 review comments on the agency's integrated 3 science assessment on ozone and other 4 photochemical oxidants. 5 First, I would like to Dr. Jon 6 Samet, members of the Clean Air Scientific 7 Advisory Committee and invited members to this 8 ozone panel for your time and your public 9 service to EPA in rendering your advice to

10 EPA. 11 I'd like to take this opportunity 12 and publicly thank Dr. Joe Brain, who serve on 13 the charter CASAC. We very much appreciate 14 your valuable service to the CASAC and of

15 course to EPA. 16 And a special welcome to Dr. Ana 17 Diez-Roux, who's joining us as a new member of 18 the charter CASAC, appreciate that. Thank 19 you, Ana, welcome. 20 This morning you will hear 21 presentations from the Agency. Up front at 22 the table here, we'd like to thank John

### 202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 Vandenberg and Dr. Jim Brown. Both of you 2 will be talking about the Agency's document,

3 the ISA. 4 Later on you will also be joined 5 by representatives from the Office of Air 6 Quality and Planning Standards, who will give 7 a talk about the update where we are on this 8 round of review for ozone. That led by Ms. 9 Lydia Wegman, Dr. Bryan Hubbell and Dr. Karen 10 Martin from OAQPS, so thank you all for being 11 here today. 12 As Aaron has indicated, we have 13 received public comments. As you know, public 14 input is a very critical input for the 15 advisory process, and I ask that the members 16 of this panel to consider the public comments. 17 I'd like to thank the public 18 commenters who submit written comments as well 19 as the speakers who will be here today to give 20 an oral presentation in person or on the 21 phone. 22 With that I'd like to thank my

### 202-234-4433 Neal R. Gross & Co., Inc. Page 11 1 staff, who make this meeting possible. As you 2 know, Holly Stallworth is the DFO of the CASAC 3 and she's unable to be here, but we want to 4 let you know that Aaron Yeow, thank Aaron for 5 especially stepping in to take over. And I 6 appreciate Aaron, who provided excellent 7 technical support to the group. 8 With that I'd like to turn the 9 meeting over to Dr. Jon Samet. 10 DR. SAMET: Okay, thank you, 11 Vanessa and Aaron, and good morning to 12 everyone. 13 Just I think what we'll do is go 14 around the room and ask the panel members to 15 introduce themselves and then we'll come back 16 and talk about the agenda. Jon Samet from the 17 University of Southern California, a pulmonary 18 physician, epidemiologist. Vanessa you've

19 heard from. 20 Judy? 21 DR. GRAHAM: Judy Graham, I'm 22 retired, my background, I'm a toxicologist.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 12 1 I've spent some time in exposure and risk

2 assessment. 3 DR. MILLER: Fred Miller, 4 independent consultant, statistics, 5 toxicology, dosimetry. 6 DR. BRAIN: I'm Joe Brain. I'm at 7 the Harvard School of Public Health. I'm a 8 lung biologist.

9 DR. HARKEMA: I'm Jack Harkema 10 from Michigan State University. I'm an 11 inhalation toxicologist and pathologist. 12 DR. VEDAL: I'm Sverre Vedal, 13 University of Washington. I'm a pulmonary 14 physician and an epidemiologist. 15 DR. BELL: I'm Michelle Bell at 16 Yale University, and I work primarily in air 17 pollution epidemiology. 18 DR. CHOCK: I'm David Chock, 19 independent consultant at University of 20 Michigan Environmental Science and 21 Sustainability. 22 DR. JACOB: Daniel Jacob, Harvard

### 202-234-4433 Neal R. Gross & Co., Inc. Page 13 1 Atmospheric Chemistry. 2 DR. ULTMAN: Jim Ultman, Penn 3 State University, dosimetry. 4 DR. FOSTER: Mike Foster, Duke 5 University Medical Center, environmental 6 health scientist. 7 DR. KLEEBERGER: Steve Kleeberger, 8 NIEHS, environmental pulmonary geneticist. 9 DR. DIEZ-ROUX: Ana Diez-Roux, 10 University of Michigan. I'm an 11 epidemiologist. 12 DR. SUH: Helen Suh, NORC at the 13 University of Chicago. I do exposure science 14 and environmental epi. 15 DR. NEUFELD: Howard Neufeld, 16 Appalachian State University, a plant 17 physiologist. 18 DR. GRANTZ: David Grantz, 19 University of California at Riverside, also a 20 plant physiologist. 21 DR. WEATHERS: Kathleen Weathers, 22 Cary Institute of Ecosystem Studies. I'm a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 biogeochemist. 2 MR. ALLEN: George Allen from 3 NESCAUM in Boston. I focus on measurement 4 methods and exposure assessment. 5 DR. FREY: Chris Frey at North 6 Carolina State University. I'm a 7 environmental engineer. 8 MR. YEOW: Just wanted to give a 9 quick reminder for the panel members to use 10 the microphone because there are people on the 11 phone. And then also a reminder for those on 12 the phone to mute your lines when you're not 13 speaking. Thank you. 14 DR. SAMET: And let's see, John 15 Bailar, if you're on the phone could you 16 introduce yourself, please? Not yet, okay. 17 So let's just spend a moment 18 looking at the agenda. We have a full day 19 beginning with hearing from the NCEA team led 20 by John Vandenberg, the update from the OAQPS 21 group led by Lydia Wegman. 22 The public comment period, I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 15 1 believe that we have 16 commenters signed up 2 as mentioned. Going to go back and have a 3 brief committee discussion of the charge 4 question and see if there are other key issues 5 that the panel feel we should discuss while

6 here. 7 And then we're going to move on to 8 a discussion of our charge questions, and we 9 already have a great deal of work done by the 10 committee members which I appreciate. 11 I'm expecting a lot of work out of 12 the committee tonight even though you may have 13 other plans, and tomorrow we'll come back and 14 have as a key objective the discussion of key 15 points that will go into the draft letter. 16 One addition to the schedule 17 coming out of discussions at the SAB with 18 Vanessa is the 8:30 a.m. tomorrow slot for the 19 opportunity to make brief clarifying remarks 20 by members of the public. 21 These might be, for example, 22 points of clarification or additional

### 202-234-4433 Neal R. Gross & Co., Inc. Page 16 1 information. This is not an opportunity to 2 repeat what would be said during today's 3 public comment session. So this is something 4 new in our agenda to provide additional 5 opportunity for public input. And we adjourn 6 tomorrow at 11:30. So that's what is 7 anticipated for our schedule. 8 (Off microphone comment.) 9 Aaron offered to remind me that 10 tomorrow should any member of the public want 11 to make a comment, please identify yourself to 12 Aaron, and these comments will be limited to 13 one minute should you choose to make a point. 14 So this is an opportunity to make brief, 15 additional points. 16 Okay, so with that review and a 17 busy day ahead, why don't we get started? 18 John, we turn to you. 19 DR. VANDENBERG: Thank you very 20 much, Dr. Samet. I'd like to extend my 21 appreciation much as Vanessa did to the Chair 22 of the CASAC as well as to the committee

### 202-234-4433 Neal R. Gross & Co., Inc. Page 17 1 members. It's a significant effort that 2 you've put into the review and your time today 3 as well as subsequently. It's very much 4 appreciated by all of us. 5 I'd also like to extend my 6 appreciation to the public for their comments 7 and for the many participants we have in the 8 room here today. 9 I'm the Director of the National 10 Center for Environmental Assessments RTP 11 Division, and my staff is here that have been 12 involved in the drafting of this document and 13 we very much appreciate your time and comments 14 as we move to finish this document. 15 I'm joined here this morning at 16 the table by Dr. Jim Brown. Dr. Brown will be 17 providing much of the overview of the changes

18 that we've made to the assessment. 19 Our timeline is, we finished the 20 first draft of this back in March of last 21 year. We had a meeting by CASAC in May and 22 the second draft came out in September, which

### 202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 is what we're reviewing today. 2 Our target is to finish the ISA 3 sometime in the February or March time frame 4 which obviously is very quick but, you know, 5 we're very optimistic that we can, and we've 6 got a very strong team working on this that we 7 can move forward given the comments that we'll 8 receive today and tomorrow as well as the 9 written review from CASAC subsequently. 10 As I mentioned, the team that we 11 have is, many of these individuals are present 12 here in the room. In addition, we have a 13 number of individuals who have served as 14 external authors to us that you can see on the 15 list there as well. 16 Together I think this represents a 17 significant effort by the agency to make sure 18 that we're identifying and evaluating and 19 communicating the state of the science for 20 ozone for the benefit ultimately of the 21 administrators' decisions to support the 22 review of the next Ambient Air Quality

### 202-234-4433 Neal R. Gross & Co., Inc. Page 19 1 Standard. 2 Just in very brief summary of some 3 of the major revisions we made in response to 4 the comments we received on the first draft is 5 we have continued to view this as a flexible 6 process where we benefit from the comments. 7 And clearly there was a lot of 8 discussion at the last meeting about the 9 executive summary, so the executive summary is 10 now identified as Chapter 1. And you might 11 wonder why, and part of that is just a 12 renumbering issue. We can again benefit from 13 comments about whether that's an effective way 14 to communicate the major findings of the 15 assessment which would be used by a number of 16 different audiences. 17 What was in Chapter 1 before, the 18 information there has essentially been parsed 19 out to other parts. We're moving towards 20 having a preamble that describes the process 21 of the Integrated Science Assessment 22 development and the causality framework and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 20 1 this doesn't change very much. And so rather 2 than having it be Chapter 1, we're moving it 3 to be a preamble that will be consistently 4 applied across the different ISAs. 5 Then turning more specifically to 6 the ozone review, we've created a preface 7 here. So what we have is a review of 8 basically the background, the historical 9 development of the ISAs over time, and again 10 that information doesn't change very much so 11 it seems to be appropriate as a preface. 12 And then other material in terms 13 of the introductory material specific to this 14 ISA has been moved into Chapter 2, which is 15 really focused on the integration of the 16 science. Trying to bring to bear the 17 framework that we have developed, the science 18 that we've reviewed and to draw those 19 causality conclusions and to communicate that 20 as what is now Chapter 2. 21 Looking to other more significant 22 changes, we've done quite a bit of background

### 202-234-4433 Neal R. Gross & Co., Inc. Page 21 1 modeling on ozone and much of this work has 2 been developed just over the course of this 3 summer, as I'm sure we'll hear comments about 4 that. We refer to that both in the body of 5 the document as well as in the appendices, and 6 we'll be largely focusing only on what's in 7 the body of the document. 8 Some of that modeling still is 9 evolving, and I think at this point we're 10 probably only going to depend upon the 11 published modeling that was put forward by the 12 scientific authors. 13 Chapter 8 is dealing in the past, 14 susceptibility, vulnerability, at risk. 15 There's a variety of terms here and we 16 continue to see even in the comments received 17 up to this point about the terminologies that 18 we're using here. 19 And in this iteration we have 20 focused on the term "at risk." And again we 21 welcome comments on that as we receive your 22 review comments.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 At this point I'd like to turn to 2 Jim Brown, and Jim's going to be reviewing the 3 more detailed information as well as the 4 charge questions. 5 DR. BROWN: Good morning. John 6 just went through some of the major changes in 7 the document. I'm going to be going very 8 quickly through our charge questions and 9 highlighting some of the changes that we've

10 made as well. 11 Starting with this, this is the 12 chapters that we now have in our document. 13 We've added a preamble and a preface as John 14 just said. 15 We've added a new Chapter 1 16 because there were many comments received 17 saying that we needed an executive summary to 18 communicate some of our findings to the public 19 and more of a lay audience as compared to what 20 is Chapter 2, our integrative summary, which 21 can be very detailed with all the science 22 coming in from all these subsequent chapters.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 23 1 So I'm going to go through the 2 charge questions very briefly. I've 3 underlined some key parts of them just again 4 to highlight some of the changes for you that 5 were incorporated into the document. 6 This is Charge Question 1. It's 7 for the preamble, preface, Chapters 1 and 8 Chapter 2. Again, there's an executive 9 summary that's been prepared and now put in 10 place in Chapter 1. 11 Chapter 1, our original Chapter 1 12 has been moved into the preamble and the 13 preface and went in to Chapter 2. We tried to 14 streamline Chapter 2 also to make it more 15 integrated as John mentioned. And you can see 16 the other underlined things such as the 17 legislative history and stuff which has now

18 been moved as well.

19 These are our causal 20 determinations for the health. I have these 21 here not to highlight a change but just to let 22 you know that we did not make a change to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 24 1 these causal determinations for the health. 2 I put that in there because when I get to the 3 eco you'll notice a small change in the causal 4 determinations there. 5 This is a new figure that we've 6 added into Chapter 2. We also have a pyramid 7 of effects in Chapter 1, but this one is a 8 little more detailed. And we tried to 9 highlight some of the evidence from the 10 different disciplines that went into our 11 conclusions that there are effects such as 12 respiratory mortality. 13 In this figure, again which is new 14 in Chapter 2, the purple indicates findings 15 that were coming in from epidemiology, green 16 is the toxicological findings and blue is some 17 of the health effects findings. And we're 18 working on a table that summarizes all of 19 those studies as well to support where these 20 conclusions are derived from. 21 This is a new figure that's also 22 now in Chapter 2 and in Chapter 9. It's meant

### 202-234-4433 Neal R. Gross & Co., Inc. Page 25 1 to help lead people through the ecological 2 effects of ozone and it refers to other 3 figures and sections within the document to 4 help navigate the reader through those 5 sections. 6 Moving on to the next charge 7 question, Chapter 3. Sections 3.4 and 8 Sections 3.9 were updated and expanded and 9 Section 3.6 was also revised. A lot of the 10 discussion in that chapter and a lot of the 11 interest to the public is in background ozone 12 or what we have historically referred to as 13 Policy Relevant Background. 14 Referring to the little schematic 15 here, what is background? Well, it's 16 something that we can't directly observe but 17 something that we can only model, and it's the 18 concentrations of ozone that would exist from 19 long range transport, from outside natural 20 influences, stratospheric ozone intrusion and 21 sources such as lightning, but no manmade 22 emissions.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 And at the bottom you can see that 2 there are different ways that you could define 3 this background ozone as well, such as in a 4 natural background where you might turn off 5 all of the manmade emissions in the entire

6 world. 7 North American background, where 8 you turn off the emissions theoretically in 9 the United States, Canada and Mexico, or the 10 U.S.-only background where you still have 11 manmade emissions in the rest of the world but 12 not within the United States.

13 I'm sure that we'll have a lot of 14 comments and discussion on this as the day 15 progresses. 16 So if I move through this too 17 quickly that's for the sake of time, and 18 please, panel, you can interrupt me at any 19 time. 20 Okay, Charge Question 3 is 21 focusing on Chapter 4, our exposure chapter. 22 And we've added some clarifying discussion on

### 202-234-4433 Neal R. Gross & Co., Inc. Page 27 1 the relevance of central site monitoring for 2 interpretation of the epidemiological studies. 3 We've revised the summary sections 4 to be more concise and focused. We've 5 prepared tables, and that's not just in this 6 chapter but throughout the other chapters. 7 We've tried to put more tables in and more 8 figures such as the ones that I've already 9 showed you to help summarize some of our 10 findings. 11 We've also added discussion on 12 averting behavior which is discussed on the 13 subsequent slide. So what is averting 14 behavior? Well, this is when people hear air 15 quality alerts and they change their behavior 16 to avoid exposure to the ambient ozone and 17 does that affect our interpretation of 18 studies. 19 There is a little bit of 20 information that is available that says that 21 some groups such as asthmatics, children and 22 adults, or individuals that experience

### 202-234-4433 Neal R. Gross & Co., Inc. Page 28 1 respiratory symptoms may change their behavior 2 but that it's not pronounced in the general 3 population. We all have to go to work still, 4 we commute, and so we tend to ignore those 5 advisories. 6 This is preliminary though, the 7 information that we have. It's only available 8 from mainly one location, Los Angeles. I've 9 moved over to the second bullet in the right

10 hand column. 11 Although we've included this we 12 did want to note that it's new data. There's 13 not a lot of data right now. It's mainly 14 again focused in one area, Los Angeles, for a 15 limited number of years when we had the higher 16 one-hour standard of .12 ppm in place, and 17 more evidence is needed as to whether these 18 effects might influence epidemiological 19 findings at our current ambient levels. 20 Moving on to our fourth charge 21 question, Chapter 5, the dosimetry and mode of 22 action. This chapter's been very much

### 202-234-4433 Neal R. Gross & Co., Inc. Page 29 1 reorganized throughout. They've tried to 2 integrate the dosimetry and have it lead more 3 into the mode of action, which has also now 4 been more linked to Chapter 6 and 7 where we 5 discuss the health effects. 6 There was a criticism that there 7 was too much health effects evidence 8 previously presented in Chapter 5, and that 9 has been moved and it's more focused just on 10 again, the mechanisms of action. 11 Here's a new figure that was 12 included in that chapter, talking about the 13 uptake of ozone which is our dosimetry 14 component, some of the reaction of the 15 secondary oxidation products. And then we 16 have a fuzzy line there where we start moving 17 into the mode of action.

18 Yes? 19 MR. YEOW: Sorry to interrupt, 20 James. Can you pull the microphone closer and 21 speak louder into it? 22 DR. BROWN: Sorry, I was trying

### 202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 not to talk too loud because I heard such an 2 echo earlier.

3 MR. YEOW: Thanks. 4 DR. BROWN: Our Charge Question 5 5 focuses on both of the health chapters, 6 Chapters 6 and 7. That's the short-term and 7 the long-term effects of ozone, respectively. 8 These chapters contain toxicological 9 controlled human exposure studies and 10 epidemiological evidence for effects of ozone.

11 We've added a lot of new 12 references. Well, they're not new references. 13 They're old references that we've tried to 14 make sure to pull in from some of our old 15 documents to really show the depth of 16 information that is available not just for the 17 controlled human exposure studies but for the 18 toxicology and the epidemiology as well. And 19 we've tried to focus more on the integration 20 with that old evidence that we had in the last

21 document.

22 We've also added a number of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 31 1 tables and figures to hopefully better convey 2 the evidence to the readers. This is an 3 example of one of the figures that was 4 included in this. This is from the controlled 5 human exposure studies. 6 There's been a criticism as to 7 there not being much evidence down below 80 8 ppb ozone, and this figure was put in to try 9 to illustrate the extent of the evidence, the 10 number of studies that are available below 80 11 ppb of ozone. 12 On that figure, unless otherwise 13 indicated the data is from chamber studies to 14 a square wave or constant concentration of 15 ozone. Some of the points have an M next to 16 them. That's for a face mask, so the subjects 17 were exposed with a face mask. 18 Other subjects have a T next to 19 them. That's studies where people were 20 exposed to a variable concentration or a 21 triangular concentration profile which you'll 22 hear other people talking about, some of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 32 1 public commenters I believe today. And that's 2 a new figure, 6.1b. 3 Our next charge question, Charge 4 Question 6, this is the Chapter 8, the at-risk 5 populations or susceptible populations 6 depending on what your preference is. 7 We've tried to focus that now on 8 the terms that were recommended last time, 9 those being mainly intrinsic and extrinsic 10 factors that affect the susceptibility of an 11 individual as well as increased dose due to 12 activity outside which may cause greater 13 exposure. 14 Charge Question 7, moving over to 15 the ecological effects. This has been 16 consolidated into fewer but more integrated 17 sections. 18 I mentioned earlier that I put up 19 the causal determination slide for the health 20 effects in humans because we didn't make 21 changes there, but I wanted to highlight that 22 we did make changes within this chapter.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 33 1 Specifically, the second and the fourth causal 2 determinations there that are grayed out have 3 been integrated into other causal 4 determinations. 5 Then that is what the footnotes on 6 this table are indicating. Footnote 1 are the 7 two causal determinations which have now 8 incorporated the information on the alteration 9 of vegetation reproduction, and Footnote 2 is 10 for the second causal determination, the 11 alteration of leaf gas exchange in vegetation. 12 Those two causal determinations 13 have that information integrated in them. So 14 we didn't throw away the information, we've 15 just integrated it into some of the other 16 causal determinations as we tried to make the 17 chapter more concise. 18 And with that I would like to turn 19 over to our second set of EPA speakers unless 20 there are questions, because we've got a busy 21 day ahead of us. 22 DR. SAMET: Let's see, are there

### 202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 questions at this point for the team? Dan?

2 DR. JACOB: Yes. I have a 3 question about the description of background 4 ozone as you say we might be talking quite a 5 bit about this today. 6 But there are two different 7 calculations of the background ozone that are 8 shown in Chapter 3. I know there's been some 9 change since the first draft. And those two 10 calculations are done with GEOS-Chem Model, 11 and for full disclosure I'm the GEOS-Chem 12 Model scientist. 13 And the background calculation 14 described in Section 3.4 as you pointed out, 15 is the published one and the one that really

16 should be used. 17 What I'm wondering about is what 18 is the other calculation that's presently in 19 Section 3.9 doing at all in that document, 20 because we know that it's incorrect. It was 21 done with a buggy version of the model and it 22 just sows confusion.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 35 1 DR. VANDENBERG: Thank you for 2 that comment. And just to be clear, one of 3 the things that we'll talk about maybe when we 4 get to Chapter 3 is that type of information. 5 Our intention at this point is to 6 not use what's in 3.9 at all because that was 7 developing even as we were developing the 8 chapter, and once we got the document 9 together, distributed it, then we realized 10 that there was some errors in the model as 11 you've just pointed out. 12 DR. JACOB: So this section is 13 going to be deleted? 14 DR. VANDENBERG: It's going to be 15 deleted, yes. Yes, it'll be deleted. 16 DR. JACOB: Thank you. 17 DR. VANDENBERG: So focusing on 18 the published papers is what our intent is. 19 The work that was done in addition was to help 20 support subsequent analysis we found there. 21 As you just pointed out there's some errors 22 there and so we'll just delete that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 36 1 DR. JACOB: Okay. 2 DR. SAMET: John, a question for 3 you. Just on the structural issue, are you 4 seeking to have uniformity across all the 5 ISAs? In other words, you know, this 6 rearrangement, preface, prologue, monologue, 7 whatever you're doing, along with Chapter 1 8 that's a general executive summary, is this 9 the standard you're seeking and have you lined 10 up the structure of the different documents as 11 they've, the different ISAs, because we're now 12 what, four or five years into ISAs? 13 Do they all look different? And 14 frankly, I can't remember, but it seems like 15 you're continuing to have evolution of the 16 structure. So what is the goal? 17 DR. VANDENBERG: Partially, and 18 that is that the parts on the front end here, 19 the new preamble, preface, the background 20 information related to the process that we use 21 and then the historical context which is the 22 preface, and some form of an executive summary

### 202-234-4433 Neal R. Gross & Co., Inc. Page 37 1 and then an integrated overview. That's what 2 we're moving towards. 3 The subsequent chapters depend 4 upon the ISA and so there is a somewhat 5 different specificity of information. So what 6 I'm saying is that I expect that in the future 7 that this will become more fixed than it has 8 been and we're going to be moving towards a 9 style of structure that will be most 10 informative and not inconsistent from one to

11 the other. 12 I think that what we've really 13 benefited from is the CASAC comments on this, 14 is to continually help us as we evolve this. 15 But I can't remember which chapter the at-risk 16 population is but the number for that, 8, may 17 be different from lead than it is from ozone 18 just because of the preceding chapters may be 19 a little different. We may not have chapters 20 on ecosystem effects, for example, for some of 21 the other ones. So the front end, we're 22 moving towards consistency and this is a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 38 1 reflection, I think, of that movement towards

2 that. 3 It perhaps is awkward here now to 4 have an executive summary and then Chapter 1, 5 if you count that overview chapter, or Chapter 6 2 actually is what it is. That's the kind of 7 thing that I think we can fix. 8 What it makes unfortunately for 9 this review, is it makes it seems like it's 10 sort of still scatter-shot a little bit. I 11 anticipate that that will be much clearer in 12 the final document than it is right now. 13 And it has been I think clear to 14 us that we can do a better job in 15 communicating in the front end, and that's 16 what this is really doing is we're fixing the

17 front end. 18 DR. SAMET: Okay, good. Thanks.

19 Joe? 20 DR. BRAIN: Yes, I have a related 21 question and comment. I really like the 22 uniform format and one can see how this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 39 1 uniform format could be adopted to different 2 pollutants. 3 On the other hand, the preamble 4 seems like it's a single document not ozone 5 specific. And I think it's incredibly 6 valuable, so my question is, you know, do you 7 see a process to gain further input, to even 8 have peer review to publish that as a 9 freestanding document? 10 It's, you know, I see it as really 11 an important tool and wouldn't like to see it 12 only in this document. It seems to me it 13 should be, you know, published in an ATS 14 journal or somehow be more widely available 15 and perhaps even considered more carefully

16 before that. 17 What plans do you have for the 18 preamble? 19 DR. VANDENBERG: Well, I 20 appreciate that comment because I agree with 21 you, and I think it would be useful for us to 22 take that and publish it and go through, you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 40 1 know, that process. 2 At this point I think our plans 3 are still evolving and we welcome those 4 comments and suggestions, because I think 5 it's, I like your comment because it, I think, 6 endorses that we've done a good job of 7 characterizing that. 8 So no specific plans, but I 9 appreciate this endorsement to move forward 10 with them. 11 DR. SAMET: Okay. Welcome, Ted. 12 Is John Bailar, are you on the 13 phone? Somebody signed on. Okay, no. Okay, 14 any other just very general overarching issues 15 to bring up? 16 Okay, then let's change teams. 17 Lydia? 18 MS. WEGMAN: Good morning, Jon, 19 and good morning to the whole panel. It's 20 very good to see all of you here and I thank 21 you as always for all the time that you take 22 in reviewing the EPA documents.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 41 1 We're going to go over a little 2 bit here of the structure that we're working 3 on for the risk and exposure assessment, and 4 I want to introduce before I go into the 5 presentation, the folks who are with me. 6 This is Karen Wesson, and she's 7 working on the risk and exposure assessment 8 along with Bryan Hubbell who is here to help 9 answer questions. Karen will do the part of 10 the presentation on the risk and exposure

11 assessment. 12 And then Scott Jenkins is here and 13 he'll be talking about the policy assessment 14 document, and Karen Martin is here as well. 15 And Travis Smith has been working on the 16 secondary standard portions of both of those 17 documents, so he's here to answer any 18 questions you may have. 19 Okay, again, what I want to do 20 briefly is go over the schedule for this 21 review and then turn it to Karen to talk about 22 the structure, the analytical components and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 the issues that we're seeing with the risk and 2 exposure assessment at this point, and then 3 Scott will cover the same issues and structure 4 for the policy assessment. 5 We wanted to go over this with you 6 in case you had any initial comments on the 7 risk and exposure assessment and our plans for 8 it, because any early feedback we get may help 9 us in putting together the first and second 10 drafts of the risk and exposure assessment and 11 then also the policy assessment. 12 So all of you know, I believe, 13 that we are no longer proceeding with the 14 reconsideration of the March 2008 ozone 15 standard, but the fact that we did pursue it 16 led to some delay as far as moving forward on 17 this review. 18 So you will see here a schedule 19 that shows a final standard in July of 2014, 20 not quite the five years contemplated by the 21 statute but as close as we feel we can get at 22 this point.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 It's shown in yellow, the meeting 2 that we're having today, and Jon's already 3 gone over the schedule for the ISA, so I'm 4 just going to go over the schedule for the 5 risk and exposure assessment. 6 What you'll see is something a 7 little different from what we've done in the 8 past, but not that different. We are linking 9 the first and second drafts of the risk and 10 exposure assessment and the policy assessment 11 documents for your review in order to try to 12 make as much progress as we can and ensure 13 that we meet the schedule that I'm showing you 14 today. 15 So you'll see in the middle block 16 that in the gray is the scope and methods plan 17 which you've already reviewed. We hope to 18 release the first draft of the risk and 19 exposure assessment in March of this year, a

20 mere two months from now. 21 And if you look at the policy 22 assessment, which is the last block on the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 44 1 page, you'll see we plan to release the first 2 draft of that in April. So we will be 3 releasing them back to back, and then we hope 4 to have a meeting with you in late May or 5 early June to review the first drafts of both 6 the risk and exposure assessment and the 7 policy assessment. 8 And then we hope to release and 9 plan to release the second draft of the risk 10 and exposure assessment in November of this 11 year with the second draft of the policy 12 assessment coming a month later in December of 13 2012, and then meet with you to review both of 14 those documents in January or February of

15 2013. 16 And then we hope to have a final 17 risk and exposure assessment in April of 2013, 18 and the final policy assessment in May of 2013 19 with a proposal in October of 2013, and then 20 as I said, the final rule in July of 2014. 21 So this is the schedule that we 22 are working on and we hope that you will be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 45 1 able to work on it with us, and as always we 2 appreciate all your help. 3 Unless anyone has questions on 4 that I'm going to turn this over now to Karen 5 Wesson, and as I say she'll talk about the 6 risk and exposure assessment. 7 And I want to just note we really 8 welcome any comments you have on the 9 structure, the analysis we have planned and 10 the issues for both the risk and exposure and 11 policy assessment documents. 12 MS. WESSON: Thank you, Lydia. So 13 as Lydia mentioned, I'll be going over some 14 slides on what we're planning for the risk and 15 exposure assessment. 16 We have a first draft that we're 17 currently working on that will be coming to 18 you for review in March, and so this is to 19 give you a little bit of insight into what we 20 are currently working on. 21 So the first slide gives a general 22 overview of the key topic areas that we're

### 202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 working on. We'll have an air quality 2 characterization, and then for the primary 3 standard we will have a characterization of 4 human exposure to ozone. In addition we'll 5 have a characterization of health risk, but 6 it's clinical based and epidemiological based. 7 We'll have a discussion of the key 8 findings based on these data for the primary 9 standard. And then for the secondary standard 10 we'll have an assessment of welfare, risk and 11 exposure and then we'll have a discussion of 12 the key findings for the secondary standard. 13 So to get into a little bit more 14 detail about this we'll flip to the next 15 slide. So for the exposure assessment we plan 16 to use the Air Pollutants Exposure Model or

17 APEX. 18 We plan to include the populations 19 of general population, school age children and 20 asthmatic school age children. All of these 21 will be included in the first draft. In 22 addition, we will also add outdoor workers and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 47 1 elderly people for the second draft. 2 We are using five years of ambient 3 data, 2006 to 2010, and we'll be calculating 4 design values for the 2006 to 2008, and then 5 the 2008 to 2010 period. 6 So for the clinical based risk 7 assessment we are also using the APEX model 8 and we'll be using the same populations and 9 the same years of ambient data. We are 10 working currently to update the exposure 11 response function from the last review with 12 results of new clinical studies. 13 Then for the epidemiological-based 14 risk assessment we have two components, a 15 city-specific analysis and then a national 16 scale analysis that we are planning to 17 include. 18 For the city-specific analysis we 19 are planning to use the benefits mapping and 20 analysis program, or BenMAP. We are going to 21 use this to evaluate short-term ozone exposure 22 for premature mortality and morbidity.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 48 1 And we're pretty excited about 2 being able to use the BenMAP program. This is 3 the first time that we've used it in the risk 4 and exposure assessment though of course we've 5 used it many times in the past for benefits

6 assessments. 7 We're excited to use it because it 8 provides a systematic approach to analyze 9 risk, it also is well documented and will 10 allow others to replicate these results very 11 easily. 12 For the city-specific 13 epidemiological based risk assessment we are 14 also using the same five years of ambient 15 data, 2006 to 2010, with the same two periods 16 of rollback, 2006 to 2008, and 2008 to 2010. 17 So flipping to the next slide, for 18 the national scale analysis for the 19 epidemiological based risk assessment we are 20 using a national scale spatial surface, so we 21 want to be able to capture ozone 22 concentrations in areas that we don't have

### 202-234-4433 Neal R. Gross & Co., Inc. Page 49 1 monitors. 2 And so to do this we're using a 3 fused surface of the CMAQ model and ambient 4 data. The ambient data will be for 2006 to 5 2008 with the model capturing the gradients in 6 between the monitors, and we're going to use 7 a CMAQ model from 2007. 8 So for the national scale 9 assessment we will also be using BenMAP to 10 evaluate the short-term ozone exposure looking 11 at premature mortality. And we will use this 12 data in addition to better understand the 13 representativeness of the selected cities by 14 comparing those selected cities to the other 15 major cities in the United States. 16 So for the secondary standard 17 we're going to also use a national scale air 18 quality surface of W126. This will also be a 19 fused surface of monitor data from 2006 to 20 2008, and the CMAQ model with 2007. 21 We'll be looking at ecological 22 risk and exposure and we'll be including

### 202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 specific case study areas for more refined 2 analysis. And then we'll also be looking at 3 ecosystem service risk assessment based on 4 ecological effects and modeling. 5 So flipping to the next slide. So 6 for the next three slides we wanted to take 7 the chance to highlight items that are new in 8 this REA that are different from the last -- 9 our review of the ozone standard, and to also 10 highlight things that have changed since the 11 scope and methods plans were put out. 12 So the first bullet is a change 13 for both, it's something new and also 14 something changed from the scope of methods 15 plans. So for the REA, for the first draft, 16 we propose to look at total health effects and 17 incidents without consideration of a 18 background concentration. 19 So this means looking at ozone 20 risk down to zero without consideration of a 21 background value. So we've given a lot of 22 time and thought to the policy questions that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 51 1 we were trying to answer in the REA and we 2 feel that it's appropriate for us to be 3 looking at ozone risk down to zero. 4 While we believe it's important to 5 understand background concentration, we 6 believe that it would be better placed in 7 implementation and we propose to consider it 8 in the REA. 9 In addition, we understand that 10 every molecule of ozone impacts risk and so we 11 propose to look at total ozone risk without 12 parsing risk into ozone from different

13 sources.

14 So on the second bullet for the 15 risk and exposure assessments, we estimate 16 ozone concentration for meeting the current 17 standard and for also meeting alternative 18 standards and we start with the recent air 19 quality data to do this. 20 For the first draft we will 21 include an estimation of ozone concentrations 22 to meet the current standard, and in the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 52 1 second draft we will also include the same for 2 meeting alternative standards. 3 So for the first draft we propose 4 to use the quadratic rollback method. It's 5 the method that we've used in the last 6 reviews. For the first draft we'll be using 7 this, and it requires that you set a 8 concentration lower bounds, a bounds that you 9 cannot roll air quality values beyond. 10 And for this, for the first draft, 11 we propose to set that lower bounds to be 12 equal to U.S. background, or ozone 13 concentration within the United States in 14 absence of all U.S. anthropogenic sources.

15 In the second draft we want to 16 evaluate a little further on possible 17 improvements of the quadratic rollback method. 18 One thing that we are looking at is how we 19 could possibly use air quality models to 20 better understand how the atmosphere may 21 respond and may be meeting the current or 22 alternative standards.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 53 1 And we'd like to look a little bit 2 more at possibly using air quality models to 3 have some type of bounding on rollback by 4 putting through alternative NOx and VOC 5 emissions reductions into the model and 6 looking at how the atmosphere is responding to 7 those and how it's doing that to meet the 8 current and alternative standards. 9 So for the secondary standard, we 10 are for the first draft looking at recent air 11 quality, but for the second draft we will be 12 including information showing the W126 metric 13 when meeting the current and alternative ozone 14 standards. And we are currently looking at 15 how to do that type of rollback method. 16 So on the last bullet, the case 17 study selections, so for the exposure and the 18 city-specific risk assessments we are 19 proposing to analyze 12 cities and they are 20 listed here. Atlanta, Baltimore, Boston, 21 Cleveland, and for Detroit, Houston, Los 22 Angeles, New York, Philadelphia, Sacramento

### 202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 and St. Louis. 2 For the first draft, for the 3 exposure and for the clinical based risk 4 assessment, we are using only the four that 5 are bolded, with all 12 being included in the 6 risk assessment. And then in the second draft 7 all 12 will be included in the exposure and 8 both the risk assessments. 9 So in selecting these cities we 10 considered data availability, including the 11 availability of air quality monitoring data, 12 health study information, and then some data 13 that's very particular to exposure modeling 14 such as AC prevalence data. 15 We also looked at current air 16 quality values. We wanted to find cities that 17 were at or above the current levels, current 18 proposed ozone standard.

19 We also wanted to make sure that 20 we were including vulnerable populations and 21 that we had geographical heterogeneity across 22 the United States.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 55 1 And then, as we discussed before, 2 we'll be providing an evaluation to make sure 3 that these 12 cities are representative of 4 other major cities within the United States 5 with respect to risk. 6 Flipping to the next slide, some 7 more key issues to discuss with relation to 8 the primary standard. So for the exposure 9 assessment, for this time around we're going 10 to look at characterization of activities and 11 environments associated with high exposure and 12 risk, and we also will be including a 13 qualitative analysis of exposure avoidance 14 behavior. 15 And then in the second draft we 16 propose to include an expanded uncertainty and 17 sensitivity analysis, such as understanding 18 better the lung function risk or including a 19 better treatment of uncertainty with respect 20 to activity data or the use of ambient data in 21 the exposure model. 22 For the risk assessment for the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 56 1 clinical-based, we're looking at evaluating a 2 new FEV model by McDonnell, Stewart and Smith. 3 We are also, as we discussed, looking at 4 estimating a total ozone risk without 5 consideration of background or the use of a

6 threshold. 7 And for the national analysis, 8 national scale risk assessment, we're going to 9 do a characterization of national distribution 10 of risk across major urban areas.

11 And then for the second draft we 12 hope to also include an expanded uncertainty 13 and sensitivity analysis, and, for example, 14 some things that we might be looking at there, 15 a possible use of a population-weighted 16 composite monitor estimate, or possible uses 17 of interpolation methods to fill in missing 18 data for ambient monitors and seeing what the 19 impact of risk is from doing that. 20 With respect to the long-term 21 metrics, we are currently evaluating air 22 quality metrics and the availability of health

### 202-234-4433 Neal R. Gross & Co., Inc. Page 571 study information with respect to the long2 term metrics. 3 We are going to wait to see how 4 these results play out and also what CASAC 5 recommends, and then based on that we may end 6 up including in the second draft a sensitivity 7 analysis looking at long-term endpoint. 8 So going to the next slide, so the 9 last slide on the REA, looking at key issues 10 with respect to the secondary standard. So 11 for the first draft we are looking at just 12 recent air quality data, as we discussed, and 13 those years will be 2006 to 2008. 14 So we're going to be looking at 15 species-specific ecosystem service analyses. 16 We're also going to be including for the first 17 time the FASOM and the i-Tree models looking 18 at large scale ecosystem effects using the 19 national scale air quality data.

20 And then for the second draft we 21 hope to include the W126 metrics in looking at 22 exposure for meeting the current and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 alternative standards, and then also including 2 some more specific case studies. 3 And then if the i-Tree model does 4 not get included in the first draft, which we 5 are hoping it does, it will be included in the 6 second draft in addition with some additional 7 modeling with FASOM with respect to using 8 rollback of the exposure data.

9 DR. HUBBELL: Can we take 10 questions? 11 MS. WEGMAN: Yes, let's take 12 questions. 13 DR. VEDAL: Yes, just with respect 14 to the risk assessment, you know, we 15 previously had two other approaches to the 16 risk assessment, something called -- I think 17 it was evidence-based, risk-based, something 18 like that. Now it's clinical-based and 19 epidemiologically-based. 20 So I just, a couple of questions, 21 the motivation for the change, and then 22 secondly, is there any correspondence between

### 202-234-4433 Neal R. Gross & Co., Inc. Page 59 1 those two approaches? 2 DR. JENKINS: I'm sorry, this is 3 Scott Jenkins. Just a quick clarifying 4 comment. When you talk about evidence-based, 5 we typically talk about evidence-based 6 considerations in the policy assessment. It's 7 not part of the quantitative risk assessment, 8 so I think we're not talking about a change 9 here from going evidence-based to what Karen's 10 talking about. It's more -- she's talking 11 about specifically the quantitative risk 12 assessment. We will still be doing the 13 evidence-based considerations in the policy

14 assessment.

15 DR. HUBBELL: One more 16 clarification on that. This is Brian Hubbell. 17 We still will be looking at, for example, 18 exposures above certain benchmarks of concern 19 that have been developed by looking at the 20 evidence. 21 So in the sense of what was done 22 in some of the past analyses was looking at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 60 1 exposures above certain levels that were tied 2 to observed health effects in clinical and 3 other studies, and we still will be including 4 that as part of the exposure analysis in 5 addition to actually estimating the clinical 6 responses that are based on the clinical 7 studies. 8 So it's still going to be there, 9 it's just that part of the exposure analysis 10 is not called out separately as a risk piece. 11 It's part of the overall exposure assessment. 12 DR. SAMET: Okay, other -- Judy? 13 DR. GRAHAM: From the earlier plan 14 I had two major concerns about the exposure 15 assessment. One of them has been alleviated, 16 so I just wanted to say congratulations. 17 You're doing all 12 cities and I don't know 18 how you accomplished that but whatever you 19 did, you done good. 20 The other question I have concerns 21 the APEX exposure model. I think very highly 22 of the model. My concern is the activity

### 202-234-4433 Neal R. Gross & Co., Inc. Page 61 1 patterns that are embedded within it and how 2 recent are they. 3 So in other words, if NHAPS is the 4 major foundation it was done umpteen million 5 years ago, and since indoor/outdoor is a huge 6 factor in exposure, I worry about old activity 7 patterns not reflecting today's -- I don't 8 know whether you call them couch potatoes or 9 computer potatoes these days. I don't know 10 how you're going to deal with changing 11 activity patterns. 12 DR. HUBBELL: So John Langstaff, 13 who's our modeler for APEX, is not here today, 14 but what we're planning to do is we've been 15 incorporating additional information on 16 activity data that's available. 17 For the first draft we're going to 18 use all the data that we have available to us. 19 One of the sensitivity analyses that we are 20 hoping to do for the second draft is to try to 21 split the data by older and newer activity 22 data to be able to look at the potential

### 202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 impact of changes in those activity patterns. 2 The degree to which we'll be able 3 to actually do that is not clear yet because 4 of the sample sizes in the different groups, 5 but our hope is that we'll be able to at least 6 start looking at some of that. 7 There was also hope that we'd be

8 able to use some of the newer datasets such as 9 the ATUS dataset, the American Time Use 10 Survey, which is a national survey that has a 11 lot of additional data. But, again -- and 12 it's got data at different time points over

13 the last several decades. 14 So we're hoping to be able to try 15 to address some of the questions. It may not 16 be in the first draft but we hope to have some 17 sensitivities and least in the second draft.

18 DR. SAMET: Fred? 19 DR. MILLER: Back to your Slide 6, 20 can you explain to me why you are going to not 21 have a consideration for background? That 22 you're doing this total health effects

### 202-234-4433 Neal R. Gross & Co., Inc. Page 63 1 incidents and -- because it doesn't exist of 2 zero exposure to ozone anywhere. 3 And as a corollary to that, if you 4 go that route, to what extent do you 5 complicate or have to do over things where you 6 eventually will end up considering some level 7 for policy background level? 8 DR. SAMET: And, actually, before 9 you answer that, because I was going to raise 10 the same concern, and I know you must have 11 thought about this, but to sort of entertain 12 a counterfactual that truly is unachievable is 13 an important decision. 14 And I think I guess the other

15 addendum I would make to what Fred 16 appropriately asked is, if you do it for one 17 pollutant are you going to do it for others? 18 MS. WESSON: So our motivation for 19 doing this, you know, was to better understand 20 total ozone risk. So whether the source of 21 ozone is coming from overseas or is coming 22 from a plant or it's coming from a source

### 202-234-4433 Neal R. Gross & Co., Inc. Page 64 1 within the United States, it's still producing 2 ozone and it's still contributing to risk. 3 And so to us it was important to understand 4 what the total ozone risk was and to leave any 5 possible implementation questions to the REA 6 or to the implementation world later on. 7 And we kind of felt like 8 consideration of background really started 9 wading into the implementation world. It was 10 basically a consideration of what was 11 possible, how would this actually be 12 implemented? And so we felt like it wasn't 13 part of the REA policy questions that we were 14 trying to address.

15 DR. HUBBELL: And one other 16 clarification I had, one of the reasons why 17 this has become more troubling to me over the 18 years that we've been doing this, applying 19 this artificial background, is that we also 20 tie to our standards. We tie our air quality 21 index, for example, in our statements about 22 public health significance of the certain

### 202-234-4433 Neal R. Gross & Co., Inc. Page 65 1 exposures. And those should be based on where 2 you expect to see the public exhibiting 3 certain health responses to ozone, and that 4 really is not tied to how much is coming from 5 the U.S. or how much is coming from natural 6 versus anthropogenic. It's tied to total 7 ozone exposure. 8 So understanding the risk that's 9 associated with the exposure we felt like was 10 the appropriate benchmark for beginning the 11 consideration of what an appropriate NAAQS

12 level should be. 13 Again, as Karen mentioned, when we 14 are looking at the incremental changes in risk 15 that are associated with meeting current and 16 alternative standards then we must consider, 17 you know, what is the likely ways in which 18 that reductionism would occur. And that's why 19 we've put in the U.S. background now and we're 20 considering these alternative approaches as we 21 move into the second draft. 22 But in terms of stating what the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 risks associated with ozone is, unless we have 2 scientific evidence that there is a threshold, 3 which again we noted that that becomes more 4 important now and that's why we highlighted 5 that we're not including a threshold based on 6 the current ISA conclusions that there is no 7 threshold, but it raises the relevance of the 8 threshold question to a much higher level when 9 we're not incorporating an air quality 10 background into the risk calculation. 11 So it's very important and we 12 understand that this is going to be something 13 that we need a lot of discussion on which is 14 why we wanted to highlight it now. 15 DR. SAMET: So why don't we call 16 this Round 1 of these discussions. I'm sure 17 there will be more. I'm actually a little bit 18 reminded and you might revisit it, the 19 discussions we had when we did BEIR VI, the 20 radon risk assessment, which EPA has adopted. 21 And there the so-called comparison 22 was counterfactual for radon risk reduction

### 202-234-4433 Neal R. Gross & Co., Inc. Page 67 1 indoors was outdoor concentration which is 2 fixed by nature and no one is going to lower 3 it, not even EPA. 4 But the same considerations were 5 there, and if you look at actually how we 6 looked at the attributable risk, we developed 7 concepts of effective attributable risk of 8 what might actually be mitigated against an 9 unachievable zero indoors that is equivalent

10 to what was outdoors. 11 And I think conceptually some of 12 the same issues were laid out there, but I'm 13 sure that we will return to discussion when we 14 see how you provide a rationale for this in 15 writing, which I think is going to be 16 critical. 17 Fred, and then Joe. 18 DR. MILLER: Can you clarify when 19 you say the implementation phase? Are you 20 saying that you're taking it out of the whole 21 process and it would be the risk manager at 22 the end saying, "well, I kind of feel like

### 202-234-4433 Neal R. Gross & Co., Inc. Page 68 1 policy relevant background is .08, and so 2 therefore, here's what my standard will be," 3 as opposed to the science of that interplay 4 between science and policy were to say, "here 5 is where we feel is a reasonable range." 6 I'm not sure what you mean by 7 saying saving it to the implementation. Are 8 you talking about SIPS and the whole thing 9 down the stream that is out of the realm after 10 this kind of a review? If so, I've got a real 11 problem with that. 12 DR. HUBBELL: Well, again, what 13 we're trying to get a better handle on, and 14 again there's going to be a lot of discussion 15 in the first draft risk and exposure 16 assessment about both our consideration of 17 what is the policy concept we're trying to 18 address, but also the potential ways of 19 looking at rollbacks when you're looking at 20 incremental risk reductions, which again we're 21 setting the standards. We're looking at 22 incremental improvements over where we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 69 1 currently are, and again, background can come 2 into those discussions about what is the ways 3 in which that risk reduction would be 4 achieved. 5 What we're saying is that when 6 we're looking at the total risk, and which is 7 our -- basically what's the size of the pie 8 that we have to work with? That we think it's 9 appropriate to get a benchmark level of that 10 that's based on the total risk from total 11 ozone exposure, rather than focusing on 12 identifying only the risk that is supposedly 13 achievable, which, again, it's a policy 14 discussion as to whether that's achievable 15 through U.S. policy or not. 16 You know, the concept of truly 17 natural background, one of the discussions 18 we've had is that it's a very difficult 19 concept. Because of the nonlinearities in 20 ozone formation it's very difficult to 21 determine exactly what you mean by natural 22 background ozone.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 The counterfactual of what would 2 happen if you zeroed out all anthropogenic 3 emissions, that's a very different concept 4 than what is attributable to anthropogenic 5 emissions within the current concentration of 6 ozone. And those are very difficult and 7 different concepts. 8 And we're not sure that it was 9 relevant determining what overall risk we are 10 trying to address in terms of total ozone. 11 What we really have to decide is how do we 12 weigh these different concepts of background 13 when we're considering the incremental 14 reductions in risk that you might achieve by 15 setting different standards. And that's why 16 we're trying to change the focus towards the 17 incremental differences between standards 18 rather than on total risk.

19 DR. SAMET: So let me see who else 20 wants to come up. I think Joe and Dave and 21 then Judy and -- okay, Joe?

22 DR. BRAIN: It's clear that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 71 1 background is important, contentious, complex, 2 and I just have a simple point. It seems to 3 me we need to have a little bit about 4 background in the preamble, but that's really 5 going to become kind of a universal document. 6 I think it's currently absent, but 7 I'd like to see, you know, number one, to 8 clarify when the background is appropriate to 9 consider. Is it the ISA, the REA, the policy 10 document? I think that should be reflected in 11 the preamble if it's really going to be as 12 useful as possible. 13 DR. SAMET: David? 14 DR. CHOCK: Yes, I have a question 15 regarding the statistical issue of the 16 background. When you're talking about the 17 lower bound of the background are you talking 18 about the mean or the background distribution? 19 DR. HUBBELL: We're referring to 20 the background distribution. 21 DR. SAMET: Judy? 22 DR. GRAHAM: I see words here,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 72 1 public health, health effects. I don't see 2 the word adversity. And I guess this is a 3 question. 4 There can be a statistically 5 significant change in a health indicator from 6 a human clinical study and it can be 7 replicated in 20 labs, et cetera, and it is 8 what it is. There is then the question of 9 what's its adversity level. 10 What do you all feel is the 11 relationship between the ISA and your policy 12 determinations to call an effect "adverse"? 13 In other words, who's responsibility is it to 14 talk about, you know, like the severity of the 15 effect versus this effect is severe enough 16 that I'm going to call it adverse? 17 Who does that and what do you need 18 from us to help you with that?

19 DR. JENKINS: So the ISA does have 20 some information on adversity of responses. 21 I mean, you have a surface spectrum of 22 adversity, going from the types of effects you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 73 1 see in clinical studies going all the way up 2 to the epi studies looking at mortality where 3 you have the more clear adverse responses. 4 With regard to the human clinical 5 end of things, we would be in the policy 6 assessment pulling from the ISA considerations 7 of adversity, and there is some, like I said, 8 some discussion in the ISA right now of 9 adversity of responses based on ATS 10 definition, based on some other factors. 11 So we will be pulling that into 12 the policy assessment as part of what we refer 13 to as our evidence-based considerations. So 14 part of those considerations will be 15 consideration of adversity of the response. 16 DR. SAMET: In the spirit of Joe's 17 mention of the preamble, this might be a18 preamble sort of issue. That is, it's cross19 cutting and general and what you say with 20 regard to ozone should hold with regard to any 21 other of the pollutants. They might give that 22 consideration. Also remember the ATS document

### 202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 was written, I think published in 2000, so -- 2 and there may be other considerations you want 3 to bring in. 4 Daniel? 5 DR. JACOB: Yes, hi. I certainly 6 appreciate it and I'm supportive of looking at 7 total ozone in terms of effects. But some of 8 the motivations presented for doing that 9 disturb me a little bit. In particular, 10 Brian, when you talked about nonlinearity of 11 ozone formation and the difficulty of 12 attributing an ozone molecule to an 13 anthropogenic or natural source. 14 Well, we can very well quantify 15 the anthropogenic enhancements of ozone and 16 from various sources, although we cannot label 17 a molecule as anthropogenic or natural we can 18 determine how human activity is affecting

19 ozone levels. 20 So I would take this out of the 21 argumentation. I think you have other very 22 good reasons for looking at the effect from

### 202-234-4433 Neal R. Gross & Co., Inc. Page 75 1 total ozone.

2 DR. SAMET: Fred? 3 DR. MILLER: Given that you're 4 talking about, for the risk assessment, 5 extracting things from the ISA, it becomes 6 even more important that the ISA is correct. 7 And I have to say your new figure, 8 2.3, for the ISA, you have got the same color 9 for altered development of the respiratory 10 tract or altered morphology as airway 11 responsiveness, and that just flat doesn't 12 fly. 13 And so when you have the primates 14 exposed to 0.15 and you have an alteration 15 permanently that would translate over in terms 16 of homology to children, and you have 17 considering these things as just -- they're 18 the same yellow as a temporary change in 19 airway responsiveness, we're going to have to 20 have some discussion about that because this 21 figure to me is extremely misleading and could 22 be misused as far as carrying over to what you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 76 1 should focus on. 2 DR. SAMET: Jim? 3 DR. ULTMAN: I was wondering about 4 how you're envisioning characterizing the 5 decrement in FEV1 from the clinical studies.6 The ISA relies very heavily on using a so7 called induced ozone effect by using filtered 8 air as the relative measure. Whereas there 9 are other suggestions, some from external 10 reviewers that we'll hear, that one should use 11 some low level or background level with 12 respect to that reference. And I'm wondering 13 what your current thinking on that is. 14 MS. WESSON: So John Langstaff 15 unfortunately is not here. He would know more 16 of the details. But I don't think that we've 17 made any decisions quite yet. I think that's 18 something that we're still trying to figure 19 out exactly how to include. 20 So I think we would -- maybe we 21 could follow up with getting an answer from 22 John for you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 77 1 DR. SAMET: The left wing of CASAC 2 has been very active. What about the right? 3 (Laughter.)

4 Helen? 5 DR. SUH: Hi, I was just wondering 6 if you could comment on your approach for 7 bringing forward some of the health results 8 for the REA and the policy assessment. So, 9 for example, are you going to bring forward 10 ones that are determined to be causal or 11 likely to be causal, or what is the -- is it

12 based on data or -- 13 DR. JENKINS: Yes, it is based on 14 the strength of the evidence. So we tend to 15 put, in both the REA and the policy 16 assessment, the most weight on the health 17 endpoints that have been judged in the ISA to 18 be causal, where the evidence is judged 19 sufficient to support a causal relationship 20 and a likely causal. 21 So we'll be placing most weight, 22 and this is consistent with the way we've done

### 202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 in other reviews where we've put most weight 2 on causal, likely causal effects and then when 3 we get to suggestive and lower we think about4 them within the context of margin of safety5 type considerations. 6 DR. SUH: I seem to recall in the

7 PM that there was some ones that were 8 suggestive, for example, that were also 9 included, and I don't remember that being done 10 for this, like, margin of safety kind of --

11 DR. JENKINS: So on coarse 12 particles for PM we had a whole body of 13 evidence that was suggestive, and that was 14 basically that the highest weight of evidence 15 judgment that was in the ISA for coarse. And 16 so basically in the policy assessment 17 everything was based on that suggestive 18 evidence. 19 In the terms of quantitative 20 assessment for PM with the suggestive 21 evidence, we didn't do a quantitative

22 assessment for coarse.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 79 1 DR. SUH: I guess I'm wondering 2 specifically is for the long-term mortality 3 for ozone, you know, there have been some 4 studies and in the ISA it's suggestive. 5 And I guess I'm just wondering 6 what's going to happen with that, because 7 that's a very important outcome. And I think 8 to me it's sort of on the cusp of whether you 9 include it or you don't, so I guess -- 10 DR. JENKINS: And I think Karen 11 alluded to this when she was talking is that 12 what we are going to do on the long term 13 quantitatively is still very much something 14 that's under consideration, and I think 15 something that we'd be looking for feedback 16 from the panel on. 17 Certainly in the policy assessment 18 we will be looking at the extent to which, you 19 know, the current short-term standard protects 20 against long-term effects that have been 21 linked to long-term exposures, but in terms of 22 quantitative assessment of long-term risks I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 80 1 think we would be looking for feedback from 2 the panel on that. 3 DR. SAMET: Let me check. Do you 4 still have a few slides to do on the policy 5 assessment? Maybe we'd better move on to 6 those and then just -- not to quiet the right

7 too much. 8 MS. WEGMAN: I was just about to 9 say, in light of time we probably should 10 quickly go through those and then see if there 11 are any other questions. 12 DR. JENKINS: Okay, so I'm going 13 to just talk quickly through the last three 14 slides, which will focus on the policy 15 assessment, starting with an overview of the 16 structure of the policy assessment. 17 So after we do the introductory 18 background materials the policy assessment 19 will be divided into two main parts. Chapters 20 2 through 4 covering the primary standard and 21 Chapters 5 through 7 covering the secondary 22 standard. Having basically parallel

### 202-234-4433 Neal R. Gross & Co., Inc. Page 81 1 structures with Chapters 2 and 5 looking at 2 the effects evidence, Chapters 3 and 6 looking 3 at -- pulling from the REA, looking at the 4 estimates of exposure some risks, and then 5 Chapters 4 and 7 laying out stats, preliminary 6 conclusions regarding the standards, the ozone 7 NAAQS. So it's a quick overview of the

8 structure. 9 Now in terms of key issues, with 10 regard to the primary standard, in the first 11 draft we'll be focusing on the adequacy of 12 public health protection provided by the 13 current ozone NAAQS. 14 We'll be looking at, as we just 15 talked about, effects that have been linked to 16 both short and long-term exposures. So we'll 17 be considering the evidence, and Dr. Vedal 18 alluded to this, the evidence-based19 considerations. We will have these evidence20 based considerations. We'll be considering 21 health effects evidence that links ozone to 22 both short-term and long-term exposures.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 And then we'll be pulling from the 2 first draft REA -- at least in the first draft 3 policy assessment we'll be pulling from the4 first draft REA where the REA estimates ozone5 related exposures, ozone-related health risks, 6 in areas that just meet the current ozone 7 standard. And this will be done through the 8 types of simulations that we always do where 9 we adjust air quality to simulate just meeting

10 that current standard. 11 The other thing that will be 12 included in the first draft is identification 13 of range of potential alternative standards 14 that will be a focus for assessment in the 15 second draft of the REA, in the second draft 16 policy assessment. And that will be largely 17 based on looking at the health evidence to lay 18 out that range of potential alternative 19 standards for future consideration. 20 In the second draft of the policy 21 assessment, in addition to looking at adequacy 22 of the current standard, we'll be looking at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 83 1 adequacy of the range of potential alternative 2 standards, pulling not only from the health 3 evidence but also pulling from the second 4 draft of the REA,\ the simulations that will 5 be included in that second draft REA looking 6 at quantitative estimates of exposure, some 7 risks that are associated with the different 8 standards within the range of alternatives. 9 So that's with regard to the 10 primary standard, and then quickly the 11 secondary standard following a similar type of 12 approach. The exception being that the first 13 draft REA is going to look at risks to 14 ecosystem services under current conditions 15 not simulating the current standard. That'll 16 be pushed into the second draft of the policy 17 assessment on the secondary standard side. 18 And, again, in the first draft 19 we'll lay out a range of potential 20 alternatives that are appropriate for our 21 further evaluation, but actually evaluating 22 the current, and that range of potential

### 202-234-4433 Neal R. Gross & Co., Inc. Page 84 1 alternatives will be put into the second draft 2 of the policy assessment. 3 MS. WEGMAN: So that's it for our 4 presentation, and I know we're short of time 5 but we appreciate all the comments we've 6 gotten and if there are more we'd love to hear

7 them. 8 DR. SAMET: Okay, so maybe there 9 are a few quick comments. Dave? 10 DR. GRANTZ: I have a quick 11 question on your idea for the second draft of 12 the REA. It was Karen's Slide 6. What do you 13 see as the issues in rolling back the W126? 14 You say you're evaluating rollback techniques 15 for this. 16 MS. WESSON: Sure. So if we were 17 to just do rollback of one monitor it wouldn't 18 be so hard. We'd adjust that monitor, you 19 know, using like the quadratic rollback 20 approach or something similar to meeting the 21 current ozone standard and alternative

22 standards and then take that data and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 85 1 calculate a W126 metric. So that wouldn't be 2 so difficult. 3 But what the problem is is that we 4 want to do this on a national scale, so we 5 have this fused surface of ambient data and 6 modeling data and we have to figure out a way

7 to roll that surface back to meet the current

8 ozone standard and then translate that to a 9 W126 metric. 10 So we have, you know, some 11 techniques that we're exploring of whether we 12 can roll back the monitors and then still use 13 the model to fuse the surface in between, 14 assuming that the model is still predicting 15 those gradients the same, just how we use the 16 model and the fused surface. You know, 17 perhaps we could go down that road. But we 18 just want to be a little bit more thoughtful 19 and think through how to get that national

20 surface of rolled back data. 21 DR. GRANTZ: So you see the 22 problem being of spatially assigning the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 metric rather than actually rolling back

2 effects? 3 MS. WESSON: Yes, I think it's 4 spatially representing that W126 metric rolled 5 back in areas where there's no monitors being 6 the biggest challenge. 7 DR. GRANTZ: Okay, thanks. 8 DR. SAMET: Well, thank you for 9 your presentations. I will say the thing that 10 I think caught the attention of many of us was 11 this idea of total risk. 12 And I think you're going to have 13 to make certain that -- and maybe we're going 14 to see obviously documents in May, June -- but 15 that there's a very clear explication of what 16 this is, why you're doing it and how this 17 follows into from REA to policy analysis. 18 As you said, there's of course -- 19 you could also calculate total PM risk, and 20 you're setting a precedent that potentially 21 spills over to PM, which of course has myriad 22 uncontrollable sources. So I think the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 87 1 formulation of this is going to be very 2 important. We'll look forward to seeing how 3 you actually say why you're doing it and what 4 you are doing, and then I think we'll be able

5 to comment further. 6 MS. WEGMAN: Thank you, Jon, and 7 thanks for raising the precedential issue, 8 because I think it's an important one that we 9 need to consider as we move forward and 10 whether there's something distinct about ozone 11 if we follow this path or whether, in fact, it 12 would apply to other pollutants. 13 DR. SAMET: Okay, thanks, and I 14 think we'll move on to the public comment 15 period. Aaron's going to describe a little 16 bit of our logistics. 17 MR. YEOW: Okay, so we're going to 18 ask the public speakers to come up front. We 19 passed out a list of public speakers and so 20 we're just going to go in order there. I 21 believe our first one's on the phone. 22 But we'll just ask the public

### 202-234-4433 Neal R. Gross & Co., Inc. Page 88 1 speakers to come up to the front there and 2 we'll give you five minutes. You'll see there 3 are lights on the table there. So it'll turn 4 green when you're within your allotted time. 5 When you have one minute left it'll turn 6 yellow and then when your time's up it'll be 7 flashing red. And at that point Dr. Samet may 8 interrupt you -- will interrupt you to let you 9 finish your sentence. For those on the phone 10 we will publicly announce when you have one 11 minute left. 12 So those public speakers, maybe 13 you could just start preparing yourselves off 14 to the side here. We have an hour and a half 15 allotted with a break in between. We'll just 16 leave that to the discretion of the Chair to

17 when we want to break for the -- 18 DR. SAMET: Right, so we will aim 19 for a break at approximately 10:30, so we'll 20 see how many of our public commenters we can

21 hear from before the break. 22 So Aaron has outlined, you will

### 202-234-4433 Neal R. Gross & Co., Inc. Page 89 1 have five minutes, and after the five minutes 2 there may be questions or comments from CASAC

3 members. 4 So, let's see, our first public 5 speaker is George Wolff from Air Improvement 6 Resource, Inc. Let's see, George, are you on 7 and ready? 8 DR. WOLFF: Yes, I am, Jon. 9 DR. SAMET: Okay, George, thanks. 10 And as you heard from Aaron, we will announce 11 when you've hit the four-minute mark. Why 12 don't you go ahead. 13 DR. WOLFF: Thank you. Good 14 morning, I'm George Wolff. I'm presenting 15 comments for the Alliance of Automobile 16 Manufacturers. John Heuss and I have prepared 17 extensive comments on the ISA which I 18 encourage you to read. However, today I'm 19 going to focus strictly on background ozone. 20 Figure this issue is extremely 21 important because PRB sets a limit on the 22 amount of risk that can be reduced. The lower

### 202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 the PRB, the more risk reduction EPA can 2 claim. 3 Anne Smith has shown that if EPA 4 had used a PRB of 40 instead of 15 to 35 which 5 they used in 2007, 92 percent to 100 percent 6 of the risk would have disappeared. 7 PRB also establishes the ozone 8 level that can be achieved from state and 9 federal control programs. An underestimation 10 of actual PRB will result in failed control 11 strategy.

12 There have been a number of 13 modeling estimates of PRB since the last staff 14 paper. All the PRB estimates since the staff 15 paper have been higher than what the staff 16 paper estimated. 17 The mean April to August PRB has 18 increased incrementally with each additional 19 study, and the highest levels that have been 20 found were the most recent one by Emery using

21 CAMx. 22 However, the 2007 staff paper

### 202-234-4433 Neal R. Gross & Co., Inc. Page 91 1 inappropriately used mean monthly diurnal 2 profiles of the PRB. This fails to capture 3 the daily variation and the important fourth 4 highest daily eight-hour maximum 5 concentration. 6 Zhang found that the fourth 7 highest eight-hour concentrations for the U.S. 8 be in the range of 35 to 45, but in the 9 Intermountain West this is 50 to 60 parts per 10 billion. 11 DR. SAMET: George, I'm sorry to 12 interrupt but I just want to make sure that 13 we're sequenced with your slides. Which slide 14 would you like to have shown right now? 15 DR. WOLFF: I am on one, two, 16 three, fourth slide, I believe. 17 DR. SAMET: Okay, and we'll give 18 you an extra 30 seconds for the interruption. 19 DR. WOLFF: Okay, thanks. 20 However, when total ozone was greater than 60, 21 the PRB frequently exceeded 50 in the West and 22 40 in the Midwest.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 92 1 Now you should be on the slide2 with the graph. And this shows that paired3 in-time ozone and PRB are positively 4 correlated at all the sites that were 5 examined. This means that PRB is higher when 6 total ozone is higher.

7 We conclude that EPA needs to use 8 daily eight-hour PRB estimates based on CAMx, 9 not monthly averages. PRB is also an 10 inappropriate measure of achievable ozone 11 levels in the East and Southwest because of 12 significant contributions from Canada and 13 Mexico. 14 The average enhancement of U.S. 15 background over PRB is shown here and it 16 ranges from 22 in Maine to 5 in Michigan. 17 However, just like it is inappropriate to use 18 monthly average PRB, it is inappropriate to 19 use monthly average enhancements. Examples 20 include but are not limited to Big Bend, 21 Texas, where frequent excursions of 50 ppb

22 occur and one of 70 occurred.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 93 1 In Unionville, Michigan, based on 2 modeling in 2001, on several occasions the USB 3 exceeded 40 ppb. Three times the total ozone 4 exceeded 75 with Canadian enhancements 5 exceeding 10, and two times Canadian

6 enhancement exceeded 30. 7 Based on this, we conclude that 8 the U.S. Background, not PRB, should be used 9 in the East and Southwest in the U.S. for risk 10 assessments and SIP planning. 11 Thank you, I'll be happy to answer 12 any questions. 13 DR. SAMET: Thank you, and on 14 time. Yes, Fred? 15 DR. MILLER: George, can you tell 16 me for the Denver, the plot that you have, was 17 that the background monitor from that area 18 close there, or what's the geographic spatial 19 distribution for what kind of monitor was used 20 to assess the PRB in this area? 21 DR. WOLFF: That is the rural 22 background monitor in the Denver area.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 DR. MILLER: Thank you. 2 DR. SAMET: Okay, any other 3 questions for our speaker? Okay, good. Thank 4 you, George. Our next speaker is G. Bruce 5 Copley, ExxonMobil Biomedical Sciences, Inc. 6 Please go ahead. 7 DR. COPLEY: Thank you, Jon. I am 8 Bruce Copley, an epidemiologist from 9 ExxonMobil Biomedical Sciences, and I want to

10 comment on two areas of concern that I have. 11 Number one, the EPA's cumulative 12 weight of the evidence methodology in general, 13 and two, the Agency's application of this 14 methodology for long-term or chronic ambient 15 ozone exposure and respiratory mortality. 16 The EPA's weight of evidence scale 17 is as follows, causal, likely to be causal, 18 suggestive of a causal relationship, 19 inadequate to infer a causal relationship and 20 not likely to be causal. 21 This framework is imbalanced, as 22 three of these five designations indicate or

### 202-234-4433 Neal R. Gross & Co., Inc. Page 95 1 suggest causality with no analogue for 2 designating noncausal evidence. The middle or 3 third category is not neutral as is commonly 4 seen such as in Likert Scales, rather it is 5 designated as suggestive. Moreover, the most 6 certain designation of the noncausality is 7 phrased in a manner that allows for the 8 possibility of a causal association. 9 This weight of evidence scale has 10 not received scientific peer review for use in 11 observational studies. Scientific peer review 12 is required for studies to be considered by 13 EPA in these NAAQS determinations. Likewise, 14 we believe that this new weight of evidence 15 framework should also be peer reviewed. 16 I will now address the EPA's 17 criteria for those designations. The basis 18 for causal is more compatible with a likely to 19 be causal classification under a more 20 objectively scientific paradigm. 21 The Agency's acceptance that 22 chance, bias and confounding can be ruled out

### 202-234-4433 Neal R. Gross & Co., Inc. Page 96 1 with reasonable confidence in observational 2 studies is not defensible, particularly in 3 light of the observed weak statistical 4 associations. 5 Consider the relative risk of 1.04 6 for respiratory mortality in Jerrett 2009, 7 which is arguably the most influential paper 8 on chronic ozone mortality. 9 As in many other chronic air 10 pollution studies, the role of chance is 11 reduced owing to the large sample size. 12 However, there are many opportunities for 13 uncontrolled bias and confounding to render 14 that relative risk as unreliable. 15 The effect of confounding by a PM 16 alone in this study and many others is almost 17 certainly greater than the effects of ozone 18 exposure. Likewise for the ever-present 19 exposure misclassification which for ozone can 20 be substantial. Unexplained regional 21 heterogeneity of effect in Jerrett et al.

22 further adds to the concerns about

### 202-234-4433 Neal R. Gross & Co., Inc. Page 97 1 reliability. 2 The Agency offers examples of 3 support for earning the causal designation as 4 follows. A, controlled human exposure studies 5 that demonstrate consistent effects, or B, 6 observational studies that cannot be explained 7 by plausible alternatives or are supported by 8 other lines of evidence such as animal studies 9 or mode of action information. 10 Controlled human exposure studies 11 cannot replicate real-world chronic exposure. 12 Consequently, observational studies with their 13 attendant weak statistical associations are 14 relied on to examine health endpoints. 15 It seems entirely plausible that a 16 constellation of factors other than ambient 17 ozone exposure, but somehow associated with 18 such exposure, could have generated those 19 small relative risks. 20 The potential for alternative 21 causal agent is high given that the stationary 22 ambient monitor measurements are a poor

### 202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 surrogate for individual and population 2 average exposure for use in epidemiology 3 studies. 4 The remaining causal criterion is 5 "evidence includes replicated and consistent 6 high quality studies by multiple 7 investigators." True replication is 8 essentially nonexistent in observational air 9 pollution epidemiology. 10 Even studies of the same 11 population such as the ACS cohort, update the 12 data or use analytical tools that differ from 13 those of previous studies. Additionally, I 14 submit that studies which lack individual 15 exposure data and cannot adequately control 16 confounding, which are characteristics of 17 those studies now being considered for chronic 18 ozone mortality, cannot establish causality. 19 True, some studies are stronger 20 than others, but relativism should not be used 21 as a substitute for reliability when assessing 22 the weight of evidence.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 99 1 Chronic mortality is a new health 2 endpoint that the EPA proposes to quantify in 3 their risk and exposure assessment and 4 regulatory impact analysis for the 2013 ozone 5 NAAQS. 6 The Agency has determined that the 7 evidence for a mortality effect is suggestive 8 of a causal relationship. Here the criteria 9 for this designation. 10 Evidence is suggestive of a casual 11 relationship when relevant pollutant 12 exposures, but is limited because chance, bias 13 and confounding cannot be ruled out. For 14 example, at least one high quality epi study 15 shows an association with a given health 16 outcome but the results of other studies are 17 inconsistent. 18 Now this allows for the 19 possibility that one so-called high quality 20 study that contradicts findings from several 21 other studies could raise that designation 22 from inadequate to infer a causal relationship

### 202-234-4433 Neal R. Gross & Co., Inc. Page 100 1 to a suggestive. 2 In short, this weighting paradigm 3 and its associated criteria is of questionable 4 validity with a bias towards designations that 5 exaggerate the certainty of causal inference. 6 In addition, there is insufficient evidence 7 for the suggestive designation for the 8 ozone/mortality relation. 9 Thank you for this opportunity. 10 DR. SAMET: Thank you. Comments, 11 questions? Fred? 12 DR. MILLER: I personally agree 13 with the suggestion that you have made that 14 the Agency should have a peer review of their 15 categories and that this is a very strong 16 situation. 17 And I was wondering to what extent 18 the other ones that you've cited, were they 19 categories that were subject to peer review 20 and publication so that there was a 21 consistency for the given field? 22 DR. COPLEY: I'm sorry, this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 101 1 weight of evidence scales that I want to have 2 them address here, are you talking about other 3 weight of evidence schemes or -- 4 DR. MILLER: Yes, you refer to 5 other category scales in that, and were those 6 scales peer reviewed and come to some 7 consensus and that's why you're suggesting

8 that -- 9 DR. COPLEY: Well, I referred to 10 Likert Scales which are a common paradigm used 11 in like surveys. But I'm not talking about a 12 competing weight of evidence scheme at this 13 point. Though I'm sure there are other ones 14 out there, I just want to address this one 15 today. 16 DR. SAMET: Let me comment, I 17 think perhaps provide some background and 18 refresh everyone's memory about these 19 categorizations. 20 There was a substantial amount of 21 interplay between this panel and EPA staff at 22 the time of sort of the redo of these

### 202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 classifications, and suggestions that EPA look 2 at, for example, what was being used by the 3 Surgeon General's report. That was updated in

4 2004.

5 Sverre and I both served on an IOM 6 committee that did substantial work on looking 7 at causal classifications, causal schemes. 8 That was the report on presumptive disability 9 decision making for veterans that has three or 10 four chapters devoted to this question. 11 And all of these materials were 12 peer reviewed, and I know there were Agency 13 discussions about these categories. So this 14 was looked at fairly carefully, Fred. I think 15 this goes back actually to the sort of the 16 time when I took over as Chair. 17 I would say just as a matter of 18 designations, this is not really about having 19 something analogous to a Likert Scale. I 20 think the PDDM, the IOM report actually does 21 a pretty good job of saying, well, what we'd 22 really like to do is quantify the degree of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 103 1 certainty and lay that out, and that of course 2 is a challenge. 3 In terms of anchoring at the 4 bottom, this is looked at by a number of 5 groups. For example, IARC, the International 6 Agency for Research on Cancer, has a category. 7 I think the concern is that one 8 can never exclude the possibility that there 9 might be some association, and I think that's 10 why there's always been a little hedging in 11 the language for the bottom end of these 12 categories. So I think I just want to make 13 clear about the origins and the nature of

14 these scales. 15 Any other questions for Dr. 16 Copley? Okay, thank you, and we'll move on to 17 our next commenter also on by phone, Neeraja 18 Erraguntla from the Texas Commission on 19 Environmental Quality. 20 So are you ready to go? And since21 you're on the phone we'll give you the four22 minute warning.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 104 1 DR. ERRAGUNTLA: Hello, yes, can 2 you hear me? 3 DR. SAMET: Yes, please go ahead. 4 DR. ERRAGUNTLA: Good morning, I 5 am Dr. Neeraja Erraguntla and I'm the Senior 6 Toxicologist at the Texas Commission on 7 Environmental Quality. I would like to thank 8 EPA for this opportunity. 9 But today I have four main points 10 to discuss. However, more extensive comments 11 are provided in our previously submitted 12 written comments. 13 Point number one, the EPA should 14 be transparent in its process of choosing key 15 studies and provide clear documentation of how 16 it arrived at its conclusions. 17 In order to determine that there 18 is sufficient evidence of an association there 19 must be an observed relationship between 20 exposure and health outcome in studies in 21 which chance, bias and confounding variables 22 could be ruled out with reasonable confidence.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 105 1 However, many studies heavily 2 relied by the EPA in the ISA are inadequate to 3 demonstrate sufficient evidence of an 4 association between short and long-term 5 exposures to ozone, cardiovascular, central 6 nervous system effects and mortality. 7 One key concern of the National 8 Academy of Sciences was EPA's consistent 9 failure to document how studies are selected 10 for review. For example, the exclusion by EPA 11 of well conducted studies if the results

12 showed no adverse health effects and the EPA 13 policy of discounting or ignoring studies 14 showing no association between ozone exposure 15 and asthma exacerbation. 16 Point number two, the roles of 17 uncertainty and bias in EPA's assessments have 18 been severely downplayed. It is essential 19 that EPA clearly discuss and characterize 20 these uncertainties. 21 For ozone, EPA relies on studies 22 that estimate personal exposure by using

### 202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 ambient monitoring data as a surrogate for 2 personal exposure. However, it is very 3 unlikely that people would ever be exposed to 4 these pollutants at concentrations measured at 5 outdoor monitors for very long periods of 6 time. 7 In fact, the average American 8 spends a large amount of time, close to 82 9 percent of time indoors, especially during the 10 heat of summer when ozone concentrations tend 11 to be at their highest. 12 Therefore, this assumption that 13 the personal exposure of an average American 14 is similar to ambient ozone concentration 15 oversimplifies and incorrectly assumes that 16 ambient monitoring data accurately reflects 17 personal exposure. 18 Point number three, it is 19 imperative that EPA distinguish true risk from 20 just association because associations are not 21 causations. While it may be possible to find 22 an association during statistical manipulation

### 202-234-4433 Neal R. Gross & Co., Inc. Page 107 1 of data, this does not necessarily demonstrate 2 causation. Application of the modified Hill 3 criteria is necessary to start to prove 4 causality. 5 Ecological epidemiological studies 6 are hypothesis-generating studies and are not 7 scientifically rigorous enough to be used as 8 a basis for policy decisions. In fact, these 9 studies used patient histories to monitor 10 exposure and assess health effects. Such 11 records are inadequate indices to associate 12 ozone exposure and health effects. 13 Further, meta-analysis of 14 ecological studies may give the appearance of 15 hard data but they have an extremely poor 16 exposure component and studies conducted to 17 date only show slight associations. 18 Point number four, EPA should rely 19 on biological and not statistical significance 20 in identifying an adverse health effect in 21 clinical studies. The definition of an 22 adverse effect with regard to exposure to air

### 202-234-4433 Neal R. Gross & Co., Inc. Page 108 1 pollutants still remains ambiguous. 2 Clinical studies evaluating health 3 effects due to ozone exposure have mainly 4 focused on decreases in lung function as 5 measured by forced expiratory volume in one 6 second. However, it has been found that daily 7 normal activities, exercise and diurnal 8 variations can themselves cause up to five 9 percent to 17 percent decrease in FEV1. Many 10 agencies have indicated at least 20 percent 11 decrease in FEV1 as an adverse effect. 12 Adams study and other clinical 13 studies have shown that ozone exposures of 14 0.06 ppm have reported only subtle 15 statistically significant effects that are not 16 only within the intra-individual variability 17 but are also substantially less than the 20 18 percent decrease in FEV1 to be found adverse. 19 In summary, despite lack of 20 compelling evidence, the ISA -- 21 DR. SAMET: One minute.

22 DR. ERRAGUNTLA: -- concludes

### 202-234-4433 Neal R. Gross & Co., Inc. Page 109 1 causal associations with long-term exposures 2 of ambient ozone and mortality. Further, the 3 ISA includes conclusions regarding a wide 4 range of health effects including stronger5 causal associations between short and long6 term exposure to ozone and newer endpoints 7 such as the effects of central nervous system, 8 cardiovascular system, reproductive and 9 developmental effects. Thank you. 10 DR. SAMET: Okay, thank you. Just 11 a point of clarification. When you referred 12 to the National Academy of Sciences and 13 concern, were you referring to the review of 14 the IRIS formaldehyde document? 15 DR. ERRAGUNTLA: In general, yes, 16 the methodology of EPA, yes. 17 DR. SAMET: I just wanted to be 18 clear because I was Chair of that committee 19 that the review done, and I think several 20 people true on that report was about the IRIS 21 process and not EPA reviews of evidence 22 generally. So I just wanted to make that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 clear. 2 DR. ERRAGUNTLA: Yes, that is 3 right. It was in general of the EPA's 4 methodology. 5 DR. SAMET: Okay, other questions, 6 comments? Okay, thank you. Then we'll move 7 on to our next commenter, Roger McClellan from 8 Toxicology and Human Health Risk Analysis. 9 Roger? 10 DR. McCLELLAN: Good day. I'm 11 Roger McClellan, the independent consultant in 12 air quality issues. It's a pleasure to again 13 address the CASAC panel. I appreciate the 14 importance of your public service and the hard 15 work that is involved, having personally 16 served as Chair of CASAC and on numerous CASAC 17 panels. 18 The challenges you face today are 19 substantial as a result of the major 20 improvements in air quality that have been 21 achieved over the last four decades and the 22 increasingly narrow margin between the NAAQS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 111 1 and ambient background levels. And as you've 2 just learned, EPA has now expressed concern 3 that every molecule of ozone carries an 4 attendant risk. 5 In the brief time I have available 6 today I want to make six points. First, it's 7 important that you recognize your critical 8 role in reviewing the adequacy of the ISA, 9 involving consideration of exposition of both 10 science and science judgments. 11 I urge you to make certain the ISA 12 clearly relates the science, the process by 13 which judgments are exercised and the 14 resulting judgments. 15 In my opinion, many sections of 16 the ISA do not follow a rigorous process in 17 exercising scientific judgments and 18 documenting how those judgments have been 19 reached. Thus, the resulting judgments are 20 open to question. 21 Two, I urge you to avoid letting 22 any personal preferences for a specific

### 202-234-4433 Neal R. Gross & Co., Inc. Page 112 1 standard outcome influence your scientific 2 review. This is especially important since 3 many of you have previously stated your 4 personal policy choice for a more stringent

5 standard for ozone. 6 Three, I urge you to approach your 7 review of the second draft ISA with the same 8 rigor you used in reviewing the first draft. 9 As an aside, it is my opinion that the ISA 10 authors did not adequately address many of the 11 concerns detailed in your written comments on 12 the first draft. 13 Four, I urge you to focus your 14 attention on the critical pieces of the ISA 15 that will inform review of the four elements 16 of the ozone standard. I urge you in 17 particular to focus on contemporary background 18 ozone levels matched to the averaging time of 19 the NAAQS and secondly, the key adverse health 20 effect endpoints. Not all pieces of this 21 encyclopedic ISA warrant equal attention from 22 you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 113 1 Five, I urge you to focus on

2 whether adverse health effects do or do not3 occur at ambient levels as described by eight4 hour averaging concentrations and their 5 related statistical distributions. 6 As we now have heard this morning, 7 with a paradigm shift for concern for ozone 8 down to zero, it's important that you really 9 look hard at that issue.

10 If adverse health effects are 11 associated with these ambient ozone profiles, 12 down to zero is then necessary to focus on the 13 nature of the concentration response 14 relationships including your confidence at 15 every level down to zero. 16 The Draft ISA puts excessive 17 reliance on observational epidemiologic 18 studies to describe concentration response 19 relationships without adequately relating the 20 substantial uncertainties at ambient levels 21 and that would say down to zero. These 22 uncertainties must be more clearly described.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 Six, I urge the panel to 2 critically evaluate the adequacy of the ISA 3 for informing policy judgments on both the 4 level and the statistical form of the NAAQS 5 recognizing these are interrelated decisions. 6 The present ISA does not 7 adequately describe the spatial and temporal 8 profile of background ozone across the U.S.A. 9 Major improvements are needed in this portion

10 of the ISA. 11 For any given indicator and 12 averaging time, the level of the standard must 13 be selected in company with the statistical 14 form, and in my opinion, consideration of the 15 relationship of the level and the form, the 16 current background ozone levels. 17 DR. SAMET: Roger, please wind up. 18 DR. McCLELLAN: I encourage you 19 that you recommend major revisions to the ISA 20 including the development of a third draft ISA 21 for review by CASAC and the public. 22 A scientifically credible ISA is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 115 1 the foundation for the rest of the ozone 2 standard review process. I feel even more 3 strongly -- 4 DR. SAMET: Again, please wind up.

5 DR. McCLELLAN: -- about the need 6 for that third draft in view of the comments 7 I've heard from Lydia Wegman and her staff 8 this morning. 9 Thank you for the opportunity to 10 make these comments. I welcome any 11 suggestions or comments you might have. 12 DR. SAMET: Okay, thank you. 13 Questions or comments, panel members? 14 Okay, I think just one comment, 15 Roger. If I remember your testimony, I'm 16 sorry, your written comments correctly, you 17 did make one comment about CASAC and proposing 18 more public meetings and I think alluded to

19 teleconferences. 20 I will say I just want to make 21 clear that all our work is done openly. And 22 in terms of teleconferences, any

### 202-234-4433 Neal R. Gross & Co., Inc. Page 116 1 teleconferences that we have where we discuss 2 substantive issues are those that are 3 announced and available. 4 I actually could not think of 5 instances where we've had subcommittee 6 meetings by phone, but if we do they would be 7 done according to, you know, procedures, and 8 involve the DFO. So I just wanted to make 9 certain that that's clear. 10 DR. McCLELLAN: Let me ask you 11 this. For a period of time, the last CASAC 12 panel I served on in terms of the PM panel 13 preceding the current PM panel, we had a 14 policy in which up to three individuals from 15 CASAC could communicate with one another, have 16 communications during the development of a 17 draft material. Has that policy changed?

18 DR. SAMET: Let me turn to Vanessa

19 to make comments here. 20 DR. VU: So Roger, we haven't 21 changed the policy that any subgroup of the 22 committee or we call it, panel, can have

### 202-234-4433 Neal R. Gross & Co., Inc. Page 117 1 conversation in the presence either by email 2 or a special phone call as they develop the 3 report. So it's a subgroup, whether we 4 actually find three or four. 5 The quorum, we define a quorum is 6 50 percent of the group, so anything less than 7 50 percent is considered subgroup. But I 8 don't recall, Roger, that we actually have any 9 subgroup discussion for the recent review. I 10 mean you can -- 11 DR. McCLELLAN: As I said, during 12 the time that I served on the PM panel that 13 policy was in place, and on the advice of 14 General Counsel from EPA the decision was made 15 that if there were three or fewer, i.e., 16 three, two communicating, they could do so. 17 I think that was a very poor 18 policy. I'm pleased to hear Jon's comments 19 that apparently at the present time you've 20 changed your mode of operation and I 21 appreciate that. I think that's a step in the 22 right direction.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 DR. VU: Thank you, Roger. 2 DR. SAMET: Okay, thank you for 3 your comments. And let's move on to our next 4 speaker, Deborah Shprentz, the Consultant to 5 the American Lung Association. Deborah? 6 MS. SHPRENTZ: Thank you for this 7 opportunity. Over the last six years we've 8 seen a number of breakthroughs in the science 9 of ozone air pollution which substantially 10 reinforced the case for strengthening the

11 ozone standard. 12 In particular, there's several new 13 chamber studies or analyses of data from the 14 chamber studies that point to ozone impacts in 15 healthy young adults down to 60 parts per 16 billion or below. 17 And we now have a new study, the 18 Kim et al. study that was specifically 19 designed to measure effects at the 60 part per 20 billion level and found adverse effects 21 including inflammation down to the 60 ppb

22 level.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 119 1 There's also stronger evidence 2 with respect to the association between ozone 3 and premature mortality. And the new studies 4 have considered the role of confounding 5 pollutants and found the effects of ozone to 6 be robust. In addition, there are two notable 7 long-term epidemiological studies finding 8 adverse effects of chronic exposure to ozone. 9 With respect to cardiovascular 10 effects, we find a large new body of research 11 looking at a full range of health endpoints 12 from physiological markers to increased risk 13 of hospital admissions to premature death, and 14 we suggest that EPA reexamine its finding of 15 suggestive of a causal relationship for 16 cardiovascular effects to consider a finding 17 of likely causal. 18 With respect to Chapter 2, the 19 executive summary, we'd like to see the key 20 findings discussed in nontechnical language 21 and plain English, because no reader of this 22 document is going to be expert in all of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 120 1 disciplines covered by this study. 2 Chapter 3 on atmospheric chemistry 3 and ambient concentrations, two points. One, 4 the document needs to discuss the large 5 increase in oil and gas exploitation in the 6 Intermountain West which has led to a concern 7 about ozone concentrations in the winter 8 months and in sparsely populated areas. 9 This is going to be a critical 10 issue for setting the standard with respect to 11 consideration of seasonality, monitor siting 12 requirements, whether the standard needs to be 13 enforced year-round. 14 Secondly, we note that the 15 discussion of PRB seems to have taken on a 16 life of its own. Ozone causes the same 17 adverse health effects regardless of the 18 source of the ozone, natural or manmade, 19 domestic or international. And we point to 20 the National Research Council's 2008 report. 21 They said defining a PRB is unnecessary for 22 establishing a level above which ozone is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 121 1 harmful to health or for estimating changes 2 due to a specific regulatory action. More 3 isn't needed for quantifying human health 4 responses to short-term ozone changes. So we 5 feel that this discussion is more properly 6 placed in the policy assessment document. 7 We really liked the presentation 8 of the integrated health data on short and 9 long-term effects in Chapter 6 and 7. We'd 10 like to see a clarification of the definition 11 of short term and long term. Are we talking 12 about five minutes, eight hours, 24 hours, a 13 week? What does long term mean? Is that 14 seasonal, yearly, over the course of 15 childhood, and so on. 16 But we really like the figures and 17 the tables that provide additional detail in 18 averaging time and concentration level, number 19 of subjects and so on, for the studies that 20 are reviewed both the new studies and the 21 older studies. 22 However, for Chapter 8 on the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 susceptible populations, we think that this is 2 a much weaker chapter than then earlier 3 chapters. And we note that the conclusions 4 from recent epidemiological studies are reeled 5 off, but there's no information provided on 6 ozone concentration levels or other pertinent 7 details and the studies are not critically 8 reviewed or placed in context with the studies 9 in the 2006 ISA which led EPA to make strong 10 findings about -- 11 DR. SAMET: Please wind up. 12 MS. SHPRENTZ: -- asthmatics as a 13 susceptible population. 14 So in closing I'd like to say 15 Chapter 8 needs a greater discussion about 16 health impacts on children and on neonates, 17 and that this chapter needs to feed into the 18 risk and exposure assessment which should 19 define elderly populations as those 65 and

20 older. 21 DR. SAMET: Again wind up, please, 22 Deborah. Wind up, please, you're past your

### 202-234-4433 Neal R. Gross & Co., Inc. Page 123 1 time.

2 MS. SHPRENTZ: Yes. And should 3 also find a way to consider health impacts on 4 children age 0 to 5 which are an important 5 group of susceptibles. 6 DR. SAMET: Okay, thank you. 7 Let's see, are there questions, comments? 8 Okay, thank you. Just again a reminder about 9 ground rules. You get a yellow light with one 10 minute remaining. I just want to make sure. 11 We have a lot of commenters to move through 12 and I want to make sure that the time is used 13 fairly. 14 Okay, next, we're going to move on 15 to William McDonnell, William F. McDonnell 16 Consulting. Bill? 17 DR. McDONNELL: Thank you for this 18 opportunity to make some remarks about a 19 dynamic ozone FEV1 exposure response model 20 that we've recently identified. 21 As you are aware, EPA has usually 22 conducted a risk assessment for FEV1 in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 124 1 conjunction with each reconsideration of the 2 NAAQS for ozone. The current risk assessment 3 relies upon a simple five-point concentration 4 response function as its health risk model. 5 The data underlying the model are 6 from a series of 6.6-hour studies all of which 7 were conducted at a single level of near 8 continuous strenuous exercise using only one

9 FEV1 measure at the end at the end of 10 exposure. Only a small fraction of the 11 population experiences ambient ozone exposure 12 under similar circumstances which limits the 13 applicability of this risk assessment. 14 We have recently identified and 15 evaluated a dynamic exposure response model 16 that allows for the prediction of the temporal 17 pattern of FEV1 response for any pattern of 18 exposure for healthy adults ages 18 to 35 19 years. 20 The coefficients for the model 21 have been estimated from 23 studies with 22 multiple time points over a wide range of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 125 1 concentration, ventilation and patterns of 2 exposure, and the data include recovery 3 following cessation of exposure. 4 Should EPA decide to update its 5 FEV1 risk assessment, this model could provide 6 the foundation of a substantially improved 7 health risk model based upon much more data. 8 The model itself has been described in 9 previous publications. 10 The inputs to the model are the 11 temporal profiles of concentration and minute 12 ventilation over body surface area during the 13 exposure period as well as age and body mass 14 index. 15 The output is the temporal pattern 16 of the population FEV1 response over the 17 entire exposure period. This population 18 response is expressed as the distribution of 19 individual responses for a given exposure or 20 it can be summarized as the mean or the median 21 or other percentiles of responsiveness or as 22 a proportion of individuals who are expected

### 202-234-4433 Neal R. Gross & Co., Inc. Page 126 1 to experience a change in FEV1 greater than 2 some given magnitude, for example, a ten 3 percent FEV1 decrement. 4 Originally, we estimated the model 5 coefficients from the data for 15 EPA studies 6 with the range of exposures that are given at 7 the bottom of the slide. In order to evaluate 8 the ability of the model to predict responses 9 in independent data we conducted an n-fold 10 cross validation using the EPA dataset. 11 So for each time point for each 12 exposure level of each study we calculated the 13 mean observed FEV1 response, and those are the 14 plotted on the y-axis. And we also calculated 15 the mean predicted response from the model 16 plotted on the x-axis. And we see good 17 agreement between those observed and predicted 18 means on this scatter plot. 19 We next applied this model that 20 was based on the EPA coefficients to mean 21 exposure and response data from seven 22 independent studies from the literature with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 127 1 the exposure characteristics given at the 2 bottom of the slide. The mean observed and 3 predicted responses clustered along the line 4 of identity, however, with a small amount of 5 overprediction. 6 Since publication of those 7 previous results, we've obtained individual 8 exposure and response data for seven studies 9 from the University of California at Davis and 10 for the recent low level exposure study from 11 EPA which extended the range of exposure 12 conditions and we combined these data with the 13 original EPA data. 14 We then reestimated the model 15 coefficients and again we found good agreement

16 between the mean observed and the mean 17 predicted responses. And note that these are 18 unpublished data.

19 And then from these same data we 20 also compared the observed proportion of 21 individuals who experienced an FEV1 decrement 22 greater than 10 percent at each time point and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 128 1 that's on the y-axis, zero to one. And we 2 calculated the proportion expected from the 3 model and again found good agreement between 4 observed and predicted responses.

5 So I would conclude that we've 6 identified a dynamic model that predicts 7 population FEV1 response for healthy 8 individuals ages 18 to 35 years exposed over 9 a wide range of variable exposure conditions. 10 This model could serve as the 11 foundation for an improved health risk model 12 in the upcoming EPA risk assessment for ozone, 13 and I recommend some discussion of this model 14 in the ISA for a possible role in the EPA risk 15 assessment for ozone. Thank you. 16 DR. SAMET: Okay, thank you. Let 17 me ask -- Sverre is ready, go ahead. 18 DR. VEDAL: Yes, so I see, you 19 know, the range of concentrations is, you 20 know, extends down to 0.04 ppm. So how do you 21 handle that, the data from say the 0.04 to 22 0.06 range that still looks like it's part of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 129 1 this linear concentration response function 2 when there's very little evidence of much 3 going on there from the human clinical 4 studies? 5 DR. McDONNELL: Well, I mean we 6 take the individual data as it is and we've, 7 you know, identified a model form that's 8 basically a differential equation that 9 accumulates dose and allows for recovery. And 10 then we have a sigmoid-shaped relationship 11 between that accumulated dose and FEV1 change 12 and we, you know, fit the model using PROC

13 NLMIXED. 14 I mean this is very nonlinear 15 model, but I'm not sure what else you're 16 getting at there in terms of how we handle the

17 data. 18 DR. VEDAL: Well, I mean it's a 19 very critical part of that concentration 20 response function --

21 DR. McDONNELL: Yes. 22 DR. VEDAL: -- you know, and you're

### 202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 suggesting we rely on your model. And so, you 2 know, some careful scrutiny of that portion of 3 the curve is needed. 4 DR. McDONNELL: Yes, I mean what 5 we do is we, you know, look very carefully at 6 the observed and the observed versus predicted 7 responses at all of the different exposure, 8 under different exposure scenarios. And, you 9 know, you can only, I mean you can quantify 10 how much difference there is between exposed 11 and predicted. 12 At some point though looking at a 13 given study there's no way to say, well, the 14 model is wrong and this study is right. I 15 mean the study itself is only an approximation 16 of reality. 17 We do have multiple, you know, 18 studies at most of these concentrations so, 19 you know, basically if the model is going 20 through the center of the data one assumes 21 that then, you know, you're getting a pretty 22 accurate prediction.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 131 1 DR. BRAIN: I have an adjacent 2 question, again, thinking of the general 3 applicability of the model. I suspect their 4 model is driven by heavy exercise. 5 To what extent does it really, is 6 it predictive at lower levels of exercise or 7 even at rest? And then similarly, I'm 8 concerned about the 18 to 35-year group. 9 That's a small slice of Americans. What about 10 35 to 100 and what about children and et

11 cetera? 12 DR. McDONNELL: You're right. 13 Much of the data are from heavy exercise 14 studies. There are a number of two-hour 15 studies at the high concentrations and then 16 the majority of the six and a half hour 17 studies are at 20 liters per minute per meter 18 squared body surface area, about 40 liters a 19 minute on average. 20 There is a six and a half hour 21 study that's done at a somewhat lower level of 22 ventilation in the literature. And then there

### 202-234-4433 Neal R. Gross & Co., Inc. Page 132 1 are a couple of unpublished exposures from 2 these new studies that we've gotten that have 3 got lower levels of exercise. 4 We also have some resting exercise 5 studies for two-hour exposures and for six and 6 a half hour exposures. It turns out that in 7 one area that the model does not do very well 8 is at resting exposures at the very high 9 levels of ozone, when you get up to 0.3 and 10 0.4 part per million of ozone. That's a 11 defect in the model somewhere. 12 It turns out not to overpredict in 13 any big way at the much lower concentrations 14 so I'm not sure that that's going to affect, 15 you know, anything relevant to the standard. 16 And I'm sorry, remind of the 17 second part of the question.

18 DR. BRAIN: The other one was the 19 limited age range in younger and older -- 20 DR. McDONNELL: Oh yes, that's the 21 only place we have data. 22 DR. BRAIN: No, I understand the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 133 1 reality. 2 DR. McDONNELL: There are plenty 3 of data at older age ranges, and I think that 4 we basically are seeing what appears to be an 5 almost linear decrease in responsiveness with 6 increasing age between the ages of 18 and 35. 7 You know, it's obviously not 8 linear to age 50 or 60 because you show an 9 improvement in FEV1, but I think one could fit 10 if one took additional data at the higher 11 ages, one could probably fit a curve that 12 would fit that. 13 When you get down below 18 all 14 bets are off. You know, we know something 15 about what happens in 8 to 11-year-old 16 children from a couple of studies at very low 17 levels of ozone, but we don't know much at all 18 between, you know, you've got this increasing 19 responsiveness curve going down to age 18 and 20 8 to 11-year-olds are here. You know, do you 21 go up and down, is it a plateau? There's just 22 no data to really support going below 18.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 DR. FOSTER: Bill, that was nice 2 presentation. Just one question and it goes 3 back to the fact that America is a polyglot 4 not only of ages but as well as ethnicities. 5 And it's pretty well been accepted 6 that certain ethnicities are more susceptible 7 to ozone particularly if you're using an FEV1 8 metric as an outcome. 9 So body surface area has been 10 shown not to be necessarily the best at the 11 scale to lung volumes, so you're going to have 12 include into your model since we're a polyglot 13 of population mixture, how are you going to

14 handle that or tweak the model? 15 DR. McDONNELL: Right. What we 16 found, body surface area does tend to explain 17 the differences between males and females. So 18 we like that. It took care of one big 19 problem. 20 We don't have any non-white 21 volunteers in these studies. There are a 22 couple of studies that suggest that, you know,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 135 1 or one study in particular comparing the 2 responses of blacks and whites and males and 3 females that there wasn't much of a difference 4 when ozone concentration was corrected for 5 body surface area. 6 That's a single study and, you 7 know, I don't know what we do with, there's no 8 evidence to suggest that there are differences 9 but I don't think there's enough evidence to 10 say there's not either. 11 DR. SAMET: We have two very quick 12 questions from my left here. 13 DR. GRAHAM: I'm thinking about 14 the advice of the NORC on how EPA should use 15 models in decision making and a few questions 16 pertinent to that and they're easy. Is your 17 model proprietary or is it totally open? 18 DR. McDONNELL: Oh, it's totally 19 open. 20 DR. GRAHAM: Okay, that's good. 21 In terms of the peer review, I mean I know it 22 was in journals. Was there an in-depth peer

### 202-234-4433 Neal R. Gross & Co., Inc. Page 136 1 review of the model structure itself and the 2 algorithms or was it superficial? 3 DR. McDONNELL: I would say it was 4 pretty superficial. I mean I think, you know, 5 John Langstaff from EPA has actually taken 6 this model though and the EPA dataset and he's 7 been able to pretty much reproduce what we've 8 done with the EPA dataset. 9 The additional data that I've 10 gotten, you know, was given to me with the 11 idea that I can't release that. So the EPA 12 would have to get those data from the original 13 authors but, you know, that's possibly doable. 14 I hope so.

15 DR. SAMET: Fred? 16 DR. MILLER: I guess don't kill 17 the messenger. OAQPS is using the chamber 18 studies in their risk assessment and you're 19 presenting a model that's much improved and a 20 much broader extension of being able to 21 facilitate the kinds of assessments that they

22 do.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 137 1 And so I commend you for the fact 2 that you're within a given species you can 3 look at CþV dot EþT and do all the things you 4 do. If you were going between species you and 5 I would have some problem, but that's not the 6 issue here. 7 What I want to reinforce though is 8 to what extent, or ask the question, of EPA 9 using in terms of your assessment, if this 10 model is not discussed here in the ISA, 11 because to me it fits very logically in the 12 discussion in 5.2.2.7, and I will be 13 recommending that in my after-meeting

14 comments. 15 But I want to get a feedback from 16 not necessarily you, but EPA's or if someone 17 can say there's not a problem using this. 18 DR. SAMET: Actually I think this 19 is probably not a comment for Bill to answer 20 but one for you to hold for when we have the 21 right people up here. 22 Jim, did you have a question?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 Yes. 2 DR. ULTMAN: Good morning, Bill. 3 It's good to see you again. I had a similar 4 question that was brought up regarding age 5 regarding obesity, because so much of the 6 population in the United States we're being 7 told continuously is obese. 8 I'm wondering what was the range 9 of the BMIs that you used in your models?

10 What was the -- 11 DR. McDONNELL: And I'm sorry that 12 I don't know that. These though were all 13 generally pretty fit people. I mean we didn't 14 have anybody that was really, really thin or 15 anyone that was obese. So this is going to be 16 within, you know, a fairly normal range of, 17 you know, people sitting around this table, 18 people that could do exercise on a treadmill 19 and that sort of thing for the most part.

20 DR. ULTMAN: What about the 21 sensitivity of the model to the BMI? How 22 sensitive is it to BMI?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 139 1 DR. McDONNELL: BMI is a 2 relatively strong effect but it explains very 3 little of the variability and the same for age 4 too. There's a fairly strong relationship 5 between age and FEV1 response. It just 6 neither of those variables explain much of the 7 variability but it's pretty sensitive. 8 DR. BRAIN: In mice, fat mice are 9 more responsive to ozone than skinny ones. 10 Obesity per se seems to be a risk factor for 11 responsiveness. 12 MALE PARTICIPANT: That's in mice. 13 (Simultaneous speaking.) 14 DR. SAMET: Young mice or old 15 mice. Okay, thank you for your presentation, 16 Bill. And I think what we should do is, we're 17 ten minutes behind but let's stick to a 15- 18 minute break. So that gets us back here at 5 19 of, so let's go on break now. 20 (Whereupon, the foregoing matter

21 went off the record at 10:39 a.m. and resumed 22 at 10:56 a.m.)

### 202-234-4433 Neal R. Gross & Co., Inc. Page 140 1 DR. SAMET: Okay, we're going to 2 continue with the public comment period. Our 3 next speaker is Christopher Emery from ENVIRON 4 International Corporation. Please go ahead. 5 MR. EMERY: Hi. Thanks for the 6 opportunity to speak to the panel today. My 7 name is Chris Emery. I develop and apply 8 regional air quality models, particularly 9 CAMx, but I'm also experienced with CMAQ, and 10 today I'm going to be talking about the 11 uncertainties related to the estimates of 12 background ozone. 13 The EPA up to this point has been 14 relying on GEOS-Chem to model the North 15 American Background ozone and recent high 16 resolution versions of that model are 17 predicting higher background levels than the 18 low resolution versions. 19 But while the seasonal means and 20 the unpaired frequencies of the model are 21 replicating measurements across the U.S. 22 pretty well, ozone levels of 060 ppb continue

### 202-234-4433 Neal R. Gross & Co., Inc. Page 141 1 to be underpredicted and time period 2 comparisons tend to exhibit low correlations. 3 Observational research has 4 suggested more natural short-term variability 5 with higher background levels exceeding 50 ppb 6 and more evidence of stratospheric intrusions 7 especially during the spring and the winter

8 seasons. 9 ENVIRON has recently completed 10 annual modeling in North America using the 11 CAMx and CMAQ regional models at 12 12 kilometers, and we've been using GEOS-Chem to 13 provide the boundary conditions. Our regional 14 modeling shows improved performance for time 15 period comparisons with measurements 16 especially at the upper end of the frequency 17 distribution as well as higher background

18 ozone. 19 Together with the results of Zhang 20 and colleagues, our analyses have demonstrated 21 that the simulated background levels are 22 strongly influenced by model resolution, so

### 202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 it's a source of first-order uncertainty. 2 Furthermore, we want to stress 3 that higher temporal resolution needs to4 accompany the higher spatial resolution. One5 hour meteorological frequency used in the 6 regional models is superior to the six-hourly 7 frequency used in global models. 8 Background estimates from the 9 global and the regional models are increasing 10 to converge and they're leading to higher PRB 11 levels or background levels in a more credible 12 way but we're far from reaching a point of 13 diminishing returns. 14 Further refinement is limited by 15 sources of higher order uncertainties and 16 today I'm going to discuss some of those that 17 we need to address. Certainly these models 18 must have certain attributes in order to close 19 to an improved characterization of background

20 ozone. 21 First, vertical resolution can't 22 be overlooked. We've been harping on

### 202-234-4433 Neal R. Gross & Co., Inc. Page 143 1 horizontal resolution for quite awhile, but 2 what we're seeing is that our modeling has 3 demonstrated a need for high vertical 4 resolution in the upper atmosphere 5 particularly to treat the dynamics of 6 tropopause folding events. 7 Additionally, higher resolution 8 reduces numerical diffusion of the large 9 stratospheric ozone gradient that ends up 10 getting into the troposphere. 11 The vertical transport algorithms 12 in both CAMx and CMAQ have recently been 13 updated to dramatically reduce numerical 14 diffusion, but our modeling shows that it's 15 still a problem when you address the upper 16 troposphere and the stratosphere with just a 17 few layers, and that's typically what's done. 18 Second, stratospheric ozone in 19 regional models are entirely defined by 20 lateral boundary conditions and that's a 21 problem because you have to rely entirely on 22 another model providing some definition of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 144 1 stratosphere. 2 We think that this problem can be 3 mitigated by explicit top boundary conditions 4 in these models from the global models and 5 employing better vertical resolution. 6 Third, wildfires and lightning NOx 7 are two natural sources that are significant 8 now we see to background ozone. Fires have 9 had an insufficient effect in GEOS-Chem 10 because they're not well resolved in space and 11 time and they don't include all the VOC 12 chemistry. 13 The regional models do a better 14 job with the associated chemistry and the 15 resolution but they simply inject emissions 16 vertically according to highly parameterized 17 profiles. 18 Beyond the obvious uncertainties 19 in emission estimates, the models themselves 20 don't account for fire convection or smoke 21 shading and we think that's leading to some 22 overpredictions from the fires.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 145 1 Lightning NOx is based on simple 2 parameterizations usually keyed to some 3 evidence for convective activity and then NOx 4 yields are usually constrained by some 5 climatological estimate. Refinements should 6 involve reconciliation with event-specific 7 data from lightning networks or other sources. 8 Also meteorological model outputs 9 have limited information on convection and 10 typically they overpredict lightning or at 11 least convective activity throughout the U.S. 12 So if that information is used in the regional 13 models, we need to be careful that the 14 lightning NOx estimates aren't overly 15 influenced by these overpredicted convective 16 activities. Convection also has a 17 ramification for vertical ozone exchange 18 within the troposphere as well. 19 So I just want to remind the panel 20 that focused process-oriented analyses can 21 help answer several questions. First, how 22 well does the modeling represent each process?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 How well does the model reproduce natural 2 ozone events according to conceptual models 3 based on observations? And how do the largest 4 model uncertainties each impact ozone, 5 background and source attribution estimates? 6 And I thank you. 7 DR. SAMET: Okay, thank you. 8 Questions or comments? Fred? 9 DR. MILLER: I appreciate your 10 comments, but are you saying that the ISA 11 doesn't treat these topics enough at this 12 point or what's the bottom line of your 13 presentation today? 14 MR. EMERY: I think the ISA needs 15 to expand the background ozone estimates, the 16 model ozone estimates to include regional 17 modeling at the finer resolution and beyond 18 that include some of the recommendations I'm 19 talking about. Just don't go with the status 20 quo with the standard model resolutions. 21 Increase model resolution especially at where 22 stratospheric influences play a role.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 147 1 DR. SAMET: Okay, thank you. Our 2 next commenter or our next speaker is Richard 3 Smith from the University of North Carolina at 4 Chapel Hill. Richard? 5 DR. SMITH: Okay, thank you. 6 Richard Smith, professor of statistics and 7 biostatistics, University of North Carolina. 8 I'm also appearing today as a consultant to 9 the American Petroleum Institute. I'd like to 10 emphasize that the comments I make are my own 11 comments. They're not the official policy of 12 either UNC or API. 13 My discussion concerns the recent 14 paper by Kim et al. that's already been 15 referred to several times. This is the most 16 recent paper on an ozone chamber experiment, 17 59 subjects exposed to 0.06 ppm ozone for 6.6 18 hours. There were also some experiments at 19 0.08 ppm. 20 As reported by Kim et al. there 21 were a number of response measures mentioned 22 but specifically about the FEV1 decrement in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 148 1 ozone exposure compared with clean air. They 2 reported a mean detriment of 1.7 percent which 3 was statistically significant at 0.05, though 4 well short of the level of about ten percent 5 or so that's usually considered medically 6 significant. And this discussion is based on 7 and looking again at the data that were kindly 8 provided by Dr. Kim. 9 So I'm going to make three 10 statistical points. The first of these 11 concerns outliers in the data and the fact 12 that the data do not very well follow a normal 13 distribution. 14 If we look at the histogram, this 15 is just the basic experiment, the 6.6 hours, 16 0.6. The histogram and the superimposed 17 normal curve with the same mean and standard 18 deviation, you can see that the histogram is 19 considerably more peaked in the middle and 20 there are outliers at both ends of the data.

21 So from that I conclude the normal 22 distribution methods are not particularly

### 202-234-4433 Neal R. Gross & Co., Inc. Page 149 1 appropriate. One comment that I would make is 2 I don't feel it's appropriate to overinterpret 3 individual outliers. For instance, there was 4 one individual in the clean air dataset who 5 showed a 17 percent FEV1 decrement, and it 6 seems to me you can only account for that as 7 experimental noise rather than anything of 8 medical significance. 9 So at least my view is that 10 statistical procedures should essentially be 11 looking to be robust against those sort of 12 outliers, and one approach to that is to take 13 a bootstrap approach which makes no assumption 14 about the form of the distribution and, in15 fact, when the confidence intervals and p16 values are directly compared with those 17 published by Kim they are fairly comparable. 18 The top line of the table, so this 19 doesn't come out very well on this screen, but 20 the top row of the table essentially shows 21 confidence intervals and p-values that are 22 fairly comparable with those published by Kim.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 150 1 But my second point is that this 2 is not very consistent across other endpoints. 3 The dataset also contained intermediate timed 4 results, at three hours 4.6, 5.6 as well as 5 6.6. Some of the subjects were tested at 0.08 6 ppm.

7 There were also for a smaller 8 subset some 18-hour post experiment

9 measurements of FEV1. Several of those 10 results also showed statistically significant 11 changes but there is some contradictions. 12 The three pairs of results I've 13 highlighted in red all show a stronger effect 14 for 0.06 than you see at 0.08. And since that 15 hardly seems to be medically plausible that 16 suggests to me there's more experimental noise 17 that we're not fully taking into account. 18 My first statistical point 19 concerns the possibility of extending the 20 basic comparison using regression analysis. 21 For this analysis again I took the clean air 22 adjusted FEV1 decrement as the response,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 151 1 examined a suite of regresses such as sex, 2 age, height, BSA and the baseline FEV1. 3 The only one of those regresses 4 that turned out to be statistically 5 significant was the baseline FEV1 adjusted for 6 height and this does have a possible 7 susceptible subgroup interpretation. Low FEV1 8 might be some indicator of a prior lung 9 disease. 10 But when you look at the scatter 11 plot there is a regression curve here. But 12 the main point I want to make here is you've 13 got to extrapolate a long way outside the 14 experimental data to get anywhere close to ten 15 percent FEV1 decrement. 16 I mean this is about five standard 17 deviations on the FEV1 scale so it's well 18 outside the range of the data. To make things 19 even more complicated, the corresponding 20 analysis at 0.08 ppm actually showed none of 21 those covariates turned out to be 22 statistically significant which is a bit hard

### 202-234-4433 Neal R. Gross & Co., Inc. Page 152 1 to explain as well. 2 So conclusions, the recent paper 3 by Kim et al. contains evidence of a small but 4 statistically significant response to 0.06 ppm 5 ozone at 6.6 hours. However, analysis of the 6 same data at different time points and 7 comparing results at 0.06 and 0.08 ppm ozone 8 still does not show a consistent pattern of 9 responses to find evidence in this dataset for 10 medically significant effects. 11 Even in a susceptible subset of 12 the population requires considerable 13 extrapolation beyond the range of the data of 14 the kind that statisticians interpreting 15 experimental data typically warn against. 16 Thank you very much for the 17 opportunity to make these remarks. 18 DR. SAMET: Okay, thank you. 19 Comments or questions? Sverre? 20 DR. VEDAL: Yes, just one. I take 21 your point about experimental noise and it's 22 a good one. The issue about, you know, hours

### 202-234-4433 Neal R. Gross & Co., Inc. Page 153 1 of time and exposure, I mean the reason 2 they're using 6.6 hours, and experimentalists 3 know this better than I do, is that there's 4 enhanced response with an increased time of 5 exposure. So the value of looking at 6 responses at lower time points are of some 7 interest but putting a lot of weight on it is 8 questionable perhaps. 9 DR. SMITH: Well, I think that's 10 fair enough, and I mean the introduction to 11 the paper makes clear that their primary 12 interest was in the 6.6 hour response. 13 But the point I was just trying to 14 make was that if you actually do look at those 15 intermediate time points you do see some 16 slightly strange results.

17 DR. SAMET: Fred? 18 DR. MILLER: Did you get the data 19 for the 0.08, because it's not reported in the 20 paper, that that study was only at 60ppb. So 21 did you have access to the subjects that also 22 were in other studies is where you were

### 202-234-4433 Neal R. Gross & Co., Inc. Page 154 1 incorporating into your analysis? 2 DR. SMITH: This is not other 3 studies. It's the same study, but of those 59 4 subjects they were actually divided into two 5 halves and 30 of them were subject to a 6 separate experiment at 0.08. 7 DR. GRAHAM: Do you know, is that 8 published anywhere? 9 DR. SMITH: The only publication 10 I'm aware of is the paper by Kim et al. I 11 think there may be a second paper in 12 preparation but I don't think it has been 13 submitted. 14 DR. SAMET: Okay, any other 15 comments? Okay, thank you. 16 DR. SMITH: Thank you. 17 DR. SAMET: All right, we'll move 18 on to our next speaker, Mark Nicolich from, I 19 guess it's COGIMET. Mark? 20 DR. NICOLICH: Hi, I'm Mark 21 Nicolich. I'm an accredited professional 22 statistician and I'm going to do a little bit

### 202-234-4433 Neal R. Gross & Co., Inc. Page 155 1 of "me too" following in on Dr. Smith's 2 analyses.

3 I used the same dataset. I had 4 all the data points. And one of the points 5 that I found interesting was that they ended 6 up analyzing about 15 percent of all the data

7 that were collected. 8 And Dr. Vedal brought up the fact 9 that initially they said they were only going 10 to look at the 6.6 hours, but the reading of 11 the protocol in the general article seemed to 12 indicate that they were going to do a more 13 complex analysis. 14 The analysis they did was 15 essentially a paired t-test, but if you read 16 the protocol, I can read it to you but it's 17 fairly complicated. So I think they initially 18 had planned to analyze all the data. 19 Anyway I analyzed all the data in 20 a parametric way and I analyzed it with a 21 difference between the control and the 22 response and the ratio of the control and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 156 1 response. And I also, since it's a repeated 2 measures experiment there are several 3 technical assumptions you can make, and so I 4 ended up analyzing the data five or six ways. 5 And in my testimony it says 6 exactly what I did, but the idea was that the 7 results were quite different. Statistically 8 significant differences were pretty much 9 dependent upon what model was used and what 10 dependent variable was used. 11 So this gives me pause, because 12 usually with statistical analysis you would 13 like to see some consistency in the results. 14 So the two points that I would like to make is 15 that to me as a statistician, the reported 16 analysis is somewhat unusual. 17 And of course the other point that 18 several of the other people have talked about 19 is that the decrement, the reported decrement 20 while being statistically significant falls 21 short of having any practical or physical or 22 meaningful difference. Okay.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 157 1 DR. SAMET: Okay, questions or 2 comments? Thank you, Mark. 3 Well say, these last two 4 presentations remind me that my colleagues at 5 Hopkins, Mark, well let me just finish, had 6 written an editorial seven years ago on 7 reproducible research. And Roger Payne, one 8 of the authors has a nice piece in Science 9 about a month ago, I think, in the issue on 10 data, describing the benefits of making data 11 available so that it can be analyzed by 12 multiple individuals. And I think it's this 13 reanalysis that can provide us some 14 understanding of how model dependent results 15 may be. 16 Mike? 17 DR. FOSTER: Just one quick 18 question. There was other outcome variables 19 in the study. Did you do the same statistical 20 evaluation? 21 DR. NICOLICH: I did FEV and FVC, 22 were the two and they were both similar.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 158 1 DR. FOSTER: I was thinking of 2 biological measurements. 3 DR. NICOLICH: No, I did not. I 4 did not look at those. 5 DR. SAMET: Okay, any other 6 comments? No, from the panel. Okay, thank 7 you. 8 Okay, next we'll move on to Nicole 9 Downey, Earth System Sciences. 10 DR. DOWNEY: Thank you very much 11 for the opportunity to speak to you today. 12 I'm going to talk a little bit about 13 background ozone and a lot of what we have 14 heard, the uncertainties in modeling 15 background ozone. 16 But then I'll move on quickly 17 because that's something everyone is talking 18 about to why I think background ozone is 19 important to consider in the health risk

20 assessment. 21 And so I'll start out by tying 22 this, as an author on two of the most recent

### 202-234-4433 Neal R. Gross & Co., Inc. Page 159 1 background ozone papers both the Zhang et al. 2 and the Emery et al., I think that the ISA 3 does a poor job of describing the 4 uncertainties in the sources of background

5 ozone.

6 So there are a few natural7 sources, these are including the Stratosphere8 Troposphere Exchange which we've all heard 9 about quite a lot, lightning production of 10 NOx, biogenic production of VOCs, wildfires, 11 soil production of NOx, and then there is of 12 course this issue of long range transport of 13 international emissions. 14 And I think for those people that 15 work on these models, these are some of the 16 most uncertain components of the models. We 17 have a lot of natural things that aren't well 18 constrained, also international emissions 19 inventories are highly uncertain. 20 There was a bottom-up inventory by 21 David Streets that when compared with 22 satellite estimated NOx emissions needed to be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 160 1 adjusted by a factor of two in order to be 2 consistent with these satellite measurements. 3 So my point is that the ISA needs 4 to more adequately discuss the sources of 5 background ozone, the uncertainties related to 6 those, and then I'll go on to say that the 7 peak background ozone concentrations are 8 pretty much that I think we can agree 9 underestimated in these models. 10 And the first is that all of these 11 processes are highly parameterized and very 12 average both in time and space. And I think 13 that when you get to refining your estimates 14 in both time and space you can help to match 15 observations but then there are numerical 16 diffusion problems, not even problems, just 17 numerical diffusion within the model that 18 washes out peak ozone signals. 19 So there's really no way to get 20 around that until you start doing sort of 21 plume-in-grid type very large changes in the

22 models.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 161 1 And then finally, we've seen from 2 what Dr. Emery presented earlier that there 3 are differences between different models and 4 these models are not converging on a single 5 answer yet. They're not even converging on

6 close to the same answer. 7 We have no idea, for example, what 8 the response from wildfires is. And there's 9 significant research that remains before the 10 models converge on a single answer. 11 My next point is quite different 12 but I think it's very important especially 13 when we consider what EPA was talking about 14 planning. And here I've shown the figure that 15 they have which describes their definition of 16 background and that is that they eliminate all 17 anthropogenic emissions of ozone precursors. 18 And the Clean Air Act mandates 19 that EPA protects public health with an 20 adequate margin of safety. And so here the 21 assumption is that if you remove all 22 anthropogenic emissions you will maximize the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 162 1 benefit to public health. 2 We know, however, that 3 anthropogenic emissions have a significant 4 positive public health impact. We can all 5 agree that people are healthier today than 6 they were say in 1700. 7 So there are things that we need.

8 We need food. We need clean water. We need 9 shelter. We need to be able to maintain that 10 shelter. We need some climate control within 11 that shelter. We need hospitals, doctors and 12 medicine, and we need the public health 13 infrastructure. 14 And so my argument here is that 15 you cannot eliminate background from the 16 health and risk assessment. Instead, you have 17 to include the anthropogenic component because 18 there is a very large public health benefit to 19 some of these processes which generate ozone 20 precursors. 21 People need heat. It generates NOx 22 but they need heat. And this is something

### 202-234-4433 Neal R. Gross & Co., Inc. Page 163 1 that we need to weigh. Now that we have been 2 so successful in bringing down ambient ozone 3 concentrations to nearly background levels 4 this is where this needs to go. We need to 5 move on to a more refined estimate. 6 And I think my final point here 7 is, you know, I have this figure, you know, I 8 just took this off of Wikipedia, but it's I 9 think a very good illustration. On the bottom 10 axis you have GDP and on the y-axis you have 11 life expectancy in years. And you can see 12 that there's a huge response in the beginning

13 of the curve. 14 And in the United States in 1840, 15 mean life expectancy was 37 years. Today it's

16 closer to 78. And so these health effects 17 that I'm talking about we've more than doubled 18 life expectancy. This is not a trivial 19 effect. This is a huge effect in terms of 20 public health. And you need to be measuring 21 the public health relative to a background 22 scenario.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 164 1 So my recommendation is that we 2 should formulate a new background scenario 3 with broad input that includes the emissions 4 which are necessary for public health. 5 Why do I think this is important? 6 I think it will change what the background 7 estimates are because ozone chemistry is 8 highly nonlinear, and I think it gets us away 9 from this idea that we can just turn off all 10 anthropogenic emissions nationally or 11 globally. 12 And I think it should be based on 13 reasonable available or best available control 14 technologies which can be deployed over the 15 five-year cycle of the NAAQS with the cost of

16 -- 17 DR. SAMET: Please wind up. 18 DR. DOWNEY: -- that change taken 19 into account. Thank you. 20 DR. SAMET: Okay, thank you. 21 Speaking of heat, we are trying to warm the 22 room up. Comments? Yes, Daniel?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 165 1 DR. JACOB: Yes, Nicole, so we 2 heard both from Chris and from you about the 3 problem with the models of reproducing the 4 upper end of the PDFs in ozone and the 5 implications for the background, and that's a 6 very well taken point. 7 And Chris suggested that a road 8 ahead might be to increase the resolution of 9 the models, and you seemed to suggest that 10 there were more intrinsic problems. Maybe it 11 was a structure for Eulerian models and was 12 the variability of sources. 13 And my question for you is at what 14 point do we have to just give up on the whole15 Eulerian modeling approaches based on bottom16 up knowledge of sources in terms of 17 calculating background ozone that may be 18 relevant to high extremes, at which point do 19 we have to say well, we need some other 20 approach based on analysis of observations, of 21 high events -- 22 DR. DOWNEY: Right. No, I agree.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 166 1 And I think the first question is, what 2 concentrations are most important for the

3 health effects? How well do the models 4 perform? If they don't perform adequately in 5 that concentration range, it should be based

6 on measurements. 7 And I think NOAA has been doing a 8 great job of making baseline ozone 9 measurements that are really interesting, and 10 I think you'll hear more about that from Sam

11 Oltmans. 12 I would encourage a move towards 13 observations in this forum. I think having a 14 network of sites that have co-located

15 measurements both ozone and CO and other trace 16 gases which would enable you to identify 17 sources would be extremely useful. That's 18 something we don't have. 19 I've spent a lot of time looking 20 at the existing data and it is just really, 21 it's hard to impossible to figure out where 22 the stuff is coming from for measurements

### 202-234-4433 Neal R. Gross & Co., Inc. Page 167 1 right now. 2 So I think the models have their 3 issues but the observational network is not up 4 to the task of doing this on a wide spatial 5 scale. But with investment in resources it

6 could. 7 DR. SAMET: Okay, other comments? 8 Okay, thank you. Next, we're going to move on 9 I guess to dual presenters within five 10 minutes. Julie Goodman and Sonya Sax from 11 Gradient. 12 DR. GOODMAN: Thank you for the 13 opportunity to speak today. Although EPA 14 claims to use the weight of evidence approach 15 in the ISA with consideration of the Bradford 16 Hill aspects and weighing of alternative views 17 on controversial issues, there is no evidence 18 that such an approach was used. 19 There are no clear statements in 20 the ISA indicating how evaluations of the 21 aspects are to be carried out, how judgments 22 are to be made regarding whether aspects are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 168 1 considered as being met and how an overall 2 judgment is to be synthesized out of 3 consideration of all of the aspects jointly. 4 Also, EPA does not weigh alternative views on 5 controversial issues. 6 If EPA were to do this it would 7 consider the view that it may not be ozone but 8 another factor that is causal for the health 9 effects associated with ozone. It would then 10 consider whether this view is less likely to 11 be true than the view that ozone is the causal

12 factor. 13 Many of the issues with ISA's 14 approach are identified in other EPA 15 assessments by a National Research Council 16 committee. These issues included an 17 inconsistent method for evaluating strengths 18 and weaknesses of studies and a lack of a 19 clear framework for evaluating the weight of 20 evidence in establishing causation. 21 Now although the causality 22 framework and some of the intended methods are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 169 1 clearly stated at the beginning of the ISA, 2 the same issues noted by the NRC committee are 3 evident in the implementation of the framework 4 and similarly were noted in the First Draft 5 Lead ISA by CASAC.

6 EPA should follow the NRC 7 committee's recommendations in a revision of 8 its weight of evidence approach. To achieve 9 this EPA should consider the hypothesis based 10 weight of evidence approach. 11 As discussed in more detail in our 12 written comments, this approach has been 13 successfully applied in evaluations of 14 potential health effects for several chemicals 15 and was also cited recently by EPA's Office of 16 Chemical Safety and Pollution Prevention in a 17 guidance document for using weight of evidence 18 for the Endocrine Disruptor Screening Program. 19 So in conclusion, the second draft 20 ISA for ozone does not follow an objective and 21 rigorous weight of evidence approach for 22 evaluating the available data. Thus, the ISA

### 202-234-4433 Neal R. Gross & Co., Inc. Page 170 1 cannot be relied upon to support a causal 2 relationship between ozone and health outcomes 3 at exposure levels below the current NAAQS.

4 EPA should follow the NRC 5 committee's recommendations to ensure its goal 6 of providing credible causal conclusions about 7 ozone related health effects in the final ISA. 8 DR. SAX: Thank you. My comments 9 specifically address the evaluation of the 10 controlled human exposure studies, and we 11 already heard from Dr. Smith and Dr. Nicolich 12 on the statistics. 13 And so I'm just going to highlight 14 some of those issues again and reiterate them 15 for your consideration. I really believe that 16 EPA's not interpreting these human exposure 17 studies appropriately and therefore these data 18 should not be relied upon to support a causal 19 relationship between ozone exposure and 20 adverse effects below the current NAAQS. 21 So in Figure 6.1 in the ISA, EPA 22 provides the dose response curve for lung

### 202-234-4433 Neal R. Gross & Co., Inc. Page 171 1 function decrements from ozone exposures 2 between 40 and 120ppb based on data from these 3 controlled human exposure studies. And then 4 EPA concludes that there's no evidence of a 5 threshold in this exposure range. 6 But again just because you're 7 fitting a statistical curve does not mean that 8 this is evidence for lack of a threshold. 9 There is evidence, for example, that 10 antioxidants can counter the ozone effects on 11 lung function and this is consistent with a 12 threshold mode of action, and this data really 13 needs to inform these dose response curves. 14 In addition, EPA doesn't include 15 any 95 percent confidence interval around each 16 point in this figure, and this would clearly 17 show that there's uncertainty and lack of a 18 statistical significance at exposures of 40 19 and 60ppb. 20 Then further, EPA asserts that the 21 controlled exposure data support an 22 association between 60ppb ozone exposure and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 172 1 lung function decrements, but the group mean 2 change in FEV1 at 60ppb was only statistically 3 significant in the study by Kim et al. 2011, 4 and not in others. 5 EPA really needs to give equal 6 weight to all statistical analyses, not only 7 those that show statistically significant 8 results, including methods that incorporate 9 all exposure concentrations and time points 10 such as in a meta-regression. 11 But at any rate, regardless of 12 whether these reported lung function 13 decrements at 60ppb are statistically 14 significant, the important issue is whether 15 they are really adverse and this has come up

16 a lot as we've heard. 17 FEV1 decrements reported at 60ppbs 18 range from 1.7 to 3.5 percent so they're well 19 within the intraday individual variability. 20 And in addition, these decrements are really 21 transient, reversible and of low severity. 22 So in closing, the results from

### 202-234-4433 Neal R. Gross & Co., Inc. Page 173 1 human exposure studies really do not support 2 a relationship between ozone exposure and 3 adverse effects below the current NAAQS 4 because these effects do not meet the criteria 5 for clinical adverse effects. 6 In fact, the lowest ozone 7 concentration associated with potential 8 adverse effects is almost 90ppb as reported by 9 Schelegle et al. 2009. Thank you. 10 DR. SAMET: Okay, thank you. 11 Questions or comments? We'll move on. Our 12 next speaker is Doug Blewitt from Air Quality 13 Resource Management. 14 MR. BLEWITT: Thank you for the 15 opportunity to speak to you today. What I'd 16 like to talk about is we've heard a lot about 17 application of models to determine background

18 and the advancements that have been made. But 19 we haven't really talked very much at all 20 about what do we do with this estimate of 21 background that we're getting. 22 And what I'm going to present to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 174 1 you today is an alternate approach that should 2 be considered in using background in a risk 3 assessment process. The information I'm going 4 to present was obtained from modeling files 5 obtained from Zhang and both Emery, so we're 6 using their model output as part of these 7 analyses. 8 We used North American Background, 9 alternate definitions would give you different 10 results. The major finding of these studies 11 is when modeled ozone was high background was 12 high. This is very different than what we've 13 seen in the previous modeling studies. And we 14 also have the issue of models are 15 underpredicting the higher end of the 16 frequency distribution. 17 So what I'm presenting here is a 18 comparison between model background and model 19 total ozone to minimize any bias effects 20 between monitoring data and modeling data. 21 And what we're doing is we're looking at 22 background ozone concentration paired in time

### 202-234-4433 Neal R. Gross & Co., Inc. Page 175 1 with total ozone, so we look at background on 2 an episodic basis as opposed to a mean basis. 3 And I'll show you some results of how that 4 will affect things. 5 This is a plot of, on the left 6 hand side is results from GEOS-Chem and on the 7 right hand side from CAMx. This is for a 8 CASTNET monitoring site in rural Colorado 9 called Gothic. The y-axis is background and 10 the x-axis is total ozone. 11 And what you see in this figure is 12 when you look at background paired with total 13 ozone, background is never less than 50 14 percent of total ozone. That's an interesting 15 finding. 16 And if you look at the total, the 17 upper end of the frequency distribution for 18 this particular site, background is roughly 80 19 to 90 percent of the total ozone. 20 If we extend this approach to an 21 urban site, now this is Denver, Colorado. On 22 the left hand side we have results for both

### 202-234-4433 Neal R. Gross & Co., Inc. Page 176 1 GEOS-Chem indicated in red and CAMx indicated 2 in blue. 3 And what you see here is that CAMx 4 is predicting background ozone much higher

5 than total ozone as a result of local sources. 6 We don't see that in GEOS-Chem because of the 7 large grid size. 8 On the right hand side what we're 9 seeing is comparing the diurnal monthly 10 profile that has been used by EPA in the past, 11 that's the red, versus the hourly paired 12 analysis. 13 And what you see is by using the 14 average we're underestimating the impacts of 15 background at the higher portions of the 16 frequency distribution and over the whole 17 frequency distribution. We've looked at this 18 comparing models to monitored. We see the 19 same trends, but we have more scatter in the

20 data. 21 The next point I'd like to make is 22 the issue of time averaging of the standard.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 177 1 We have a toxicological time frame, we also 2 have an atmospheric time frame. 3 In the past, EPA has not developed 4 rigorous correlations analysis between the 5 risk estimates that are done through APEX 6 versus the eight-hour average of the standard. 7 And this is an important thing. It was 8 brought up by Roger McClellan this morning. 9 The last slide I'd like to show is 10 just how important this issue of time 11 averaging is. The upper two slides indicate 12 changes in emissions from 1970 to 2008 for NOx 13 and VOCs. These are nationwide averages. 14 If you look at the bottom graph, 15 the upper portion of that graph is changes in 16 one-hour ozone concentrations and which shows 17 a dramatic decrease. The lower portion of the 18 graph -- 19 DR. SAMET: Please wind up. 20 MR. BLEWITT: -- is eight-hour 21 concentrations, we show very little decrease. 22 Thank you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 178 1 DR. SAMET: Okay, thank you. 2 Questions, comments? Yes, Daniel? 3 DR. JACOB: So with regard to this 4 figure, what is your point? That the ISA 5 doesn't sufficiently discuss long-term trends? 6 MR. BLEWITT: No, the issue is 7 that the risk work has been done on one-hour 8 average concentrations. We have an eight-hour 9 standard. What is the relationship between 10 the one-hour exposure values that have been 11 used for risk and the level of the standard? 12 That's an important issue. 13 And what we're seeing in this14 figure is that the peak concentrations long15 term trend are decreasing if we look at it on 16 an hourly basis. The long-term trends of an 17 eight-hour average have very little change. 18 And what's really going on here is 19 during the morning rise in ozone or the decay 20 in the evening, NOx emission reductions are 21 causing higher ozone from less scavenging and 22 we have a compensating effect. We're raising

### 202-234-4433 Neal R. Gross & Co., Inc. Page 179 1 the trough and we're pushing the peak down. 2 With this form of the standard, 3 compliance is going to be very difficult as 4 you start to approach background levels. So 5 you have this complication of background 6 that's very close to the standard, and now we 7 have this form of the standard with averaging 8 times undefined very well. 9 I mean the ISA needs to be very 10 clear in terms of averaging time. Every place 11 that's referenced in that document should have 12 an averaging time associated with that 13 concentration, because otherwise it's 14 impossible to make comparisons here. 15 DR. SAMET: Okay, other questions 16 or comments? Okay, thank you. 17 MR. BLEWITT: Thank you very much.

18 DR. SAMET: We'll move on to our 19 next speaker, John Jansen, Southern Company. 20 MR. JANSEN: Thank you. I'm John 21 Jansen, Principal Scientist for Southern 22 Company. I'm speaking to you today on behalf

### 202-234-4433 Neal R. Gross & Co., Inc. Page 180 1 of the Utility Air Regulatory Group concerning 2 background levels of ozone. 3 The background level of ozone in 4 ambient air is a key question in the review of 5 the National Ambient Air Quality Standards for 6 ozone. Characterization of background air 7 quality affects whether the NAAQS are 8 attainable, which may not be something that 9 EPA can legally consider when deciding whether 10 or how to revise the NAAQS. 11 However, it also affects what if 12 any benefits might be expected as a result of 13 the implementation of any revisions of the 14 NAAQS which is the key issue when deciding 15 whether the revision of the NAAQS is 16 appropriate. I'm going to address two issues 17 related to determining background ozone

18 levels. 19 First, how should it be defined? 20 EPA previously referred to Policy Relevant 21 Background or PRB, which referred to ozone 22 levels predicted to occur in the United States

### 202-234-4433 Neal R. Gross & Co., Inc. Page 181 1 in the absence of North American anthropogenic 2 emissions of ozone precursors, VOCs, NOx and

3 CO. 4 In the second draft of the ISA, 5 EPA now refers to "North American Background" 6 or simply "background." These terms, however, 7 are defined in a way that is essentially 8 indistinguishable from that of PRB, that is, 9 ozone attributable to natural sources10 everywhere including stratospheric11 tropospheric exchange of ozone and from 12 anthropogenic sources outside of continental 13 North America. 14 This definition of background 15 ozone levels is inappropriate. It zeroes out 16 emissions of ozone precursors in Canada and 17 Mexico as if they could be controlled under 18 the Clean Air Act NAAQS program. 19 EPA's justification for this 20 approach is apparently the Agency's perception 21 that such emissions can be controlled through 22 international agreements with Canada and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 182 1 Mexico. While it may be theoretically true 2 that the U.S. could enter into a treaty with 3 Canada and Mexico to reduce emissions of ozone 4 precursors, such a treaty would not be part of 5 the Clean Air Act, negotiating and 6 implementing it would not be tied to the 7 deadlines of the Clean Air Act for NAAQS 8 attainment nor would it be likely to require 9 elimination of all emissions of ozone 10 precursors in those countries. 11 Instead, background should be 12 defined as the level of ozone that could be 13 achieved in the U.S. if all anthropogenic 14 emissions of ozone precursors in this country 15 were eliminated. 16 In other words, it would assume 17 current emission rates of ozone precursors 18 outside the United States would continue or 19 perhaps increase, and it would assume 20 continuing natural emissions of ozone 21 precursors worldwide. 22 I should note that applying this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 183 1 definition may in some cases produce estimates 2 of background ozone levels that are 3 considerably higher than those produced by 4 EPA's unrealistic approach. 5 In work done for EPA by ICF, for 6 example, the summer average maximum daily 7 eight-hour background ozone level in the 8 Northeast was 8.58ppb higher using my 9 definition of background than using EPA's 10 definition. 11 Once this more realistic 12 definition of background ozone is agreed upon, 13 the next question is what the actual 14 background level or levels of ozone are. 15 EPA argues that modeling must be 16 used to determine background ozone levels 17 because even remote monitoring sites are 18 affected by long range transport of 19 anthropogenic sources of ozone within North 20 America.

21 But that should not mean that the 22 data from remote monitoring sites should be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 184 1 ignored in favor of predictions produced by 2 chemical transport models, let alone the 3 predictions of a single GEOS-Chem model. 4 As the ISA itself recognizes, 5 chemical transport models including GEOS-Chem 6 have their own uncertainties and inaccuracies. 7 A recently published paper by Emery and others 8 concluded that wildfires, lightning, 9 Stratospheric-Tropospheric Exchange contribute 10 significantly to uncertainty in modeled 11 predictions of background ozone both when 12 GEOS-Chem was used on its own and when it was 13 used in combination with CAMx model. 14 What should be done then is to 15 derive background concentrations and perhaps 16 a range of plausible background concentrations 17 using predictions produced by a variety of 18 models and using monitoring data as a check of 19 the plausibility of these predictions. 20 I note that this use of model 21 predictions and monitoring data is consistent 22 with the recommendations of McDonald-Buller

### 202-234-4433 Neal R. Gross & Co., Inc. Page 185 1 and others in a recent critical review 2 concerning means for establishing background 3 ozone concentrations. 4 Further, background ozone levels 5 must be specified in a manner that is relevant 6 to the NAAQS, which is currently specified as 7 the three-year average of the fourth highest 8 daily maximum eight-hour ozone concentration. 9 Simply looking at seasonal or even annual 10 average background levels is inadequate. 11 Given the present standard, the 12 relevant averaging period for estimates of 13 background concentrations is eight hours, and 14 the key question is what the contribution of 15 background ozone is to the fourth highest

16 ozone values -- 17 DR. SAMET: Please wind up. 18 MR. JANSEN: -- at sites where the 19 value exceeds 75ppb of the standard or other 20 levels that are under consideration. Thank 21 you. 22 DR. SAMET: Okay, thank you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 186 1 Questions or comments? Okay, thank you very 2 much. Next, Samuel Oltmans from the 3 University of Colorado at Boulder. 4 DR. OLTMANS: Thank you. I'm 5 currently a senior research associate at the 6 Cooperative Institute for Research in the 7 Environmental Sciences, a joint 8 NOAA/University of Colorado institute. API 9 provided funding to prepare these remarks. 10 These are, however, my own views on this 11 topic. 12 A significant portion of my 13 research career has been devoted to measuring 14 and understanding background ozone in the 15 atmosphere. 16 Although North American Background 17 is not a directly measured quantity, I believe 18 it is very important to make measurements of 19 what I will term background ozone not only as 20 a validation tool for models, but also as a 21 quantity that can be directly compared with 22 measurements made at locations that must meet

### 202-234-4433 Neal R. Gross & Co., Inc. Page 187 1 air quality compliance requirements. 2 I established the Ozonesonde 3 Program at Trinidad Head, California in 1997, 4 and the Surface Ozone Monitoring Program at 5 this site in 2002 for the express purpose of 6 measuring baseline ozone entering the west

7 coast of the U.S. 8 As I will show, the relatively 9 remote exposed location at Trinidad Head is 10 well located for measuring and understanding 11 background ozone. 12 In the spring, Trinidad Head 13 consistently sees hourly average ozone mixing 14 ratios greater than 50 parts per billion and 15 an April average daytime value of over 45 16 parts per billion and a range of maximum 17 hourly averages between 54 and 65ppb. 18 At the top of the boundary layer 19 at approximately 2 kilometers, average ozone 20 mixing ratios are 50 parts per billion in both 21 the spring and the summer. 22 We've used both trajectories and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 188 1 local wind information to determine conditions



### 2 representative of air coming off the Pacific



### 3 Ocean. During the daytime hours the ozone



### 4 measured at Trinidad Head is overwhelmingly



### 5 representative of the marine background. This



### 6 is the conclusion of a number of studies in



### 7 addition to our own.



### 8 Regular aircraft measurements



### 9 above Trinidad Head which measure a number of



### 10 trace species including carbon monoxide in



### 11 ozone show that air coming onshore has levels



### 12 of carbon monoxide that are representative of



### 13 global background at the latitude of the



### 14 station and implying that we are also



### 15 measuring the background ozone signal.



### 16 Ozonesonde measurements as part of



### 17 CalNex show that ozone measurements at sites



### 18 running along the coast of California have



### 19 similar average ozone concentrations to



### 20 Trinidad Head in the lower troposphere, thus



### 21 ozone measured at Trinidad Head is generally



### 22 representative of air entering the coast of California.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 189 1 From the CalNex ozonesonde data, 2 when we screen the data below 3 kilometers for 3 possible North American influence there is 4 essentially no difference in ozone amounts 5 from the complete set of measurements. 6 The influence from the 7 stratosphere at lower altitudes is most 8 pronounced at the most southerly site. Asian9 transport is most prominent at mid10 tropospheric levels. 11 Interior continental locations 12 could also provide useful information on 13 background ozone levels. An example at Denali 14 National Park in Alaska shows that the highest 15 ozone amounts at this remote site are not 16 associated with North American influence but 17 long range transport from Eurasia. 18 Analysis of ozone data from other 19 relatively remote locations along with 20 ancillary constituent data supports the 21 conclusion that ozone observations from such 22 locations are often representative of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 190 1 background conditions. 2 Recent model results, this is from 3 a model, GFDL, Geophysical Fluid Dynamics 4 model, suggests that background ozone has a5 greater contribution from upper tropospheric6 lower stratospheric sources than earlier model 7 results. This model has a full stratospheric 8 chemistry. 9 Background ozone makes a 10 substantial contribution to observe ozone at 11 concentrations greater than 50 parts per 12 billion. 13 Air entering the West Coast of the 14 U.S. in the spring has relatively high ozone 15 mixing ratios that appear to be higher than 16 models predict. 17 Intensive ozone observations as 18 part of CalNex confirm that ozone measured at 19 Trinidad Head is representative of air 20 entering the West Coast of the U.S. Biomass 21 burning both in North America and Eurasia can 22 produce significant enhancements in background

### 202-234-4433 Neal R. Gross & Co., Inc. Page 191 1 ozone. Recent model results suggest that 2 background ozone has a greater contribution 3 from stratospheric sources. 4 DR. SAMET: Please wind up. 5 DR. OLTMANS: And finally, a 6 broader perspective on background ozone can be 7 provided using observations along with the 8 modeled background ozone. 9 DR. SAMET: Okay, thank you. 10 Questions or comments? Dan? 11 DR. JACOB: Sam, could you 12 elaborate on what you said, that models tend 13 to underestimate ozone at Trinidad Head, 14 because that has not been my experience. 15 DR. OLTMANS: Yes, at the higher, 16 not on the average but when you look at the 17 distribution of ozone as Nicole pointed out 18 and as you've pointed out, when you get to the 19 higher, you get the dispersion in the model 20 it's not going to show the higher values that 21 you see at that particular site. 22 DR. JACOB: So you're referring to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 192 1 the high extremes?

2 DR. OLTMANS: Yes.

3 DR. SAMET: Joe? 4 DR. BRAIN: A question out of 5 ignorance. So there's vertical change in 6 ozone levels, what kind of topography causes 7 mixing? I mean is it, you know, the hills of 8 San Francisco or the Rocky Mountains before 9 Denver? You know, can you make some general 10 statements about conditions that bring -- 11 DR. OLTMANS: Well, at Trinidad 12 Head itself, which is in the marine boundary 13 layer, you're mostly looking at ozone that is 14 coming directly on to the coast. When you get 15 inland from California, the ozonesonde 16 observations show that the higher terrain is 17 really intercepting the ozone coming onshore 18 between 1-1/2 and 3 kilometers. 19 DR. BRAIN: So the ground level 20 ozones at Trinidad Head are not always the 21 best predictor of what you might experience as 22 you move east?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 193 1 DR. OLTMANS: That's correct. 2 DR. BRAIN: Some of the higher, 3 that's one of your main points?

4 DR. OLTMANS: Yes. 5 DR. SAMET: Okay, thank you. 6 Next, Allen Lefohn from A.S.L. & Associates. 7 DR. LEFOHN: Thank you very much. 8 It's good to be here from Montana especially 9 this time of year. Next overhead, please. 10 Why background PRB is important. 11 Correctly estimating the hourly averages of 12 PRB is important because of human health risk 13 and meeting the standard. Next slide. 14 The stratosphere is an important 15 component. Sufficient evidence exists to 16 illustrate that the stratosphere contributes 17 to PRB ozone at the surface of both high and 18 low elevation sites. The key question is how 19 frequently does STT-S or STE enhance 20 concentrations at these high and low elevation 21 sites? Next overhead, please. 22 Lefohn et al. in 2001 pointed out

### 202-234-4433 Neal R. Gross & Co., Inc. Page 194 1 that STE processes frequently contribute to 2 hourly average ozone concentrations greater or 3 equal to 50ppb during the winter and spring at 4 high and low elevation sites across southern 5 Canada and northern U.S. STE processes can6 contribute to violations of the U.S. eight7 hour standard. That's what we published in

8 2001. 9 The recent findings of Langford et 10 al. did document that STE episodes in Colorado 11 resulted in exceedances of the U.S. eight-hour 12 standard during the springtime. 13 Cooper et al. report that 14 descending stratospheric intrusions and Asian 15 pollution plumes play an important influence 16 on ozone concentration distributions along the 17 California coast. 18 Langford et al. report that STT 19 processes enhance surface ozone concentrations 20 at the Crestline, California ozone monitoring 21 site. The site experiences as you know some 22 of the highest ozone exposures in the U.S.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 195 1 Recent findings by Emery et al. as 2 reported, results indicate that PRB was well 3 over 60ppb in the West and the Intermountain 4 West due to event-oriented type of activities 5 such as stratospheric intrusion and wildfires. 6 Ambrose focused on STE and Asian 7 long range transport to the Pacific Northwest 8 and confirmed that these processes were very 9 important. 10 And Lin et al. report that 11 stratospheric contribution in North America 12 background in the spring is larger than that 13 from Asian transport. That was the slide that 14 Sam Oltmans just presented. 15 The frequency of STT-S 16 enhancements, Lefohn et al. published last 17 year investigated the frequency of the 18 processes and their associated enhancements at 19 12 surface ozone monitoring sites in the 20 western and northern tier of the U.S.

21 We concluded that the STT-S 22 contributions were frequent during specific

### 202-234-4433 Neal R. Gross & Co., Inc. Page 196 1 months and appeared to enhance the surface 2 ozone concentrations at both high and low 3 elevation monitoring sites. 4 Ludwig et al., using data from 5 radioactive debris injected into the 6 stratosphere during nuclear weapons testing in 7 the 1960s concluded that the stratosphere 8 contributed to ground level ozone 9 concentrations with the maximum occurring in 10 the springtime at both high and low elevation 11 surface monitoring sites. 12 The areas of greatest 13 stratospheric contribution was estimated to be 14 along the eastern slope of the Rocky 15 Mountains, upper Midwest and in a band 16 stretching from Texas into the northeastern

17 U.S. 18 Our current monitoring research 19 program, not monitoring, but our current 20 effort. I'm sorry. The most recent effort 21 looks at 39 ozone monitoring sites. Our 22 results indicate that stratospheric

### 202-234-4433 Neal R. Gross & Co., Inc. Page 197 1 contributes to enhanced ozone hourly averaged 2 concentrations greater and equal to 50 at both 3 high and low elevation monitoring sites across 4 many areas in the U.S., and our initial 5 analysis indicates that the spatial pattern 6 generally agreed with the predictions of 7 Ludwig et al. 8 And now these are the locations of 9 the 39 sites across the U.S. Some are 10 CASTNET, some are the EPA AQS. Mount 11 Washington site that was pointed out to us we 12 have used as well as the other sites. 13 This is the number of 14 statistically significant months with ozone 15 enhancements greater and equal to 50. Going 16 from Crestline all the way across to Mount 17 Washington, these are the number of months 18 with statistically significant effects between 19 STT greater and equal to 50 from 2007 to 2009. 20 The high elevation sites in the 21 west and inter-mountain west experience ozone 22 concentration enhancements frequently

### 202-234-4433 Neal R. Gross & Co., Inc. Page 198 1 occurring during the spring, summer and fall. 2 The frequency of STT-S events is greater at 3 higher elevation than at lower elevation sites 4 but both were frequent. 5 Concluding remarks, the 6 stratosphere frequently contributes to North 7 American Background ozone concentrations at 8 the surface of both high and low elevation 9 monitoring sites. 10 And finally, modeling results 11 reported indicate that the background 12 contribution was largest in the 50 to 80ppb 13 range. The GEOS-Chem models appear to 14 underestimate the frequently occurring hourly 15 average PRB ozone concentrations greater and 16 equal to 50. Thank you. 17 DR. SAMET: Okay, thank you. 18 Questions? Daniel, not surprised. 19 DR. JACOB: Yes. I apologize. 20 Half of the comments have to do with PRB and 21 that's fair enough. 22 The last point on, what is the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 199 1 evidence that GEOS-Chem underestimates the 2 background ozone levels at lower, higher than 3 50? I understand 70ppb. 4 DR. LEFOHN: Yes, it's your own 5 data. As we debated in Austin, it's the 6 rotation point of one of the curves that you 7 show in Zhang et al. in the supplemental part. 8 When one looks very closely it's truly 9 subjective that one can say, I think I see it

10 at 70. 11 And I think during the discussion, 12 Nancy had indicated, Nancy Brown had indicated 13 she thought it was 65. Upon closer look it 14 really looks more like 50 is where there's a 15 rotation. And we presented that in our, that 16 Sam and I did report into the Docket that used 17 your particular thing. 18 In addition, Meiyun Lin presented 19 evidence in a rural model that greater and 20 equal to 50 was an indication. And it seems 21 to fit with, at least our statistical 22 relationship it shows that above 50 we seem to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 200 1 have good relationship with STT at some sites 2 during certain times of the year. 3 DR. SAMET: Okay, other comments? 4 Okay, thank you. 5 DR. LEFOHN: Thank you. 6 DR. SAMET: And heading for our 7 last good-bye, no means the least public 8 commenter, Milan Hazucha from the University 9 of North Carolina at Chapel Hill. 10 DR. HAZUCHA: Thank you. I am 11 Professor Milan Hazucha, the Department of 12 Medicine, School of Medicine and the Center 13 for Environmental Medicine, Asthma and Lung 14 Biology, University of North Carolina Chapel 15 Hill. 16 My research interests include 17 controlled human exposure studies of air 18 pollutants, particularly ozone, PM, sulphur 19 oxides, nitrogen oxides, specifically nitric 20 oxide and carbon monoxide.

21 These comments reflect some of the 22 main points Dr. Allen Lefohn and I submitted

### 202-234-4433 Neal R. Gross & Co., Inc. Page 201 1 in written form to the Docket. The views 2 expressed herein are exclusively the authors' 3 and do not represent any official policy of 4 the institutions in which we are employed or 5 any other organization. 6 First point. The use of filtered 7 air may not be an appropriate control exposure 8 because a zero ppb ozone filtered air 9 generated in the laboratory does not exist 10 under ambient or indoor air conditions. 11 We believe that it is important 12 for EPA to discuss in the ISA whether 13 statistically significant effects observed at 14 concentrations below the current standard when 15 compared to filtered air control retain the 16 same statistical significancy if the results 17 were compared to Policy Relevant Background 18 ozone concentrations.

19 The latest research results 20 published in the literature indicate that 21 hourly average concentration greater or equal 22 of 50 parts per billion frequently occur under

### 202-234-4433 Neal R. Gross & Co., Inc. Page 202 1 PRB conditions at some sites in the U.S. 2 Thus, comparing ozone responses to an 3 unrealistic filtered air control exposure is 4 misleading. 5 Second, comparing the average 6 changes across corresponding time intervals 7 using either the absolute or relative 8 differences between ozone and filtered air9 responses and expressing them as quote "ozone10 induced" unquote is misleading. 11 The filtered air responses in such 12 adjustments may substantially quote 13 "artificially" unquote enhance or diminish the 14 magnitude of ozone response. This presents 15 potentially misrepresentation of the results. 16 In order to correctly interpret 17 what the quote "ozone-induced" unquote effects18 are, it is necessary to discuss pre- to post19 exposure differences as well. 20 Third, temporal pattern of changes21 provide important information on intra22 individual variability of response. With

### 202-234-4433 Neal R. Gross & Co., Inc. Page 203 1 considerable between and within exposure 2 variability of individual's FEV1, the utility 3 of using only the end exposure FEV1 value for 4 health assessment is inadequate. 5 Fourth, it is unsettling that the 6 Agency has modified its policy on the 7 acceptance of research data for the support of8 the national standard by accepting non peer9 reviewed material as well. The acceptance of10 material which is not available for a peer11 reviewed scrutiny casts doubts on the quality 12 of data on which the EPA recommendations and 13 conclusions are based. 14 Fifth, we suggest that the EPA 15 write a section in the ISA that discusses the 16 similarities between human health and 17 vegetation research results. 18 There are a number of important 19 similarities between human health and 20 vegetation research findings in both the 21 mechanisms as well as the pattern of response 22 that should not be ignored. For example,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 204 1 ozone effects are cumulative, and two, peak 2 concentrations appear to be more important in 3 eliciting the effects than the averaging of 4 ozone concentrations would suggest. 5 These findings noted by vegetation 6 researchers formed a basis for recommending a 7 cumulative exposure index that provides 8 greater weight to the higher ozone 9 concentration versus the mid-level values. 10 Controlled human laboratory 11 studies have shown that there is a 12 disproportionately greater pulmonary function 13 response from higher hourly average ozone 14 concentrations than from the lower hourly 15 average values. Thus, the efficacy of the 16 current eight-hour standard is reduced by not 17 reflecting adequately the dose response 18 relationship which is not monotonic over an 19 eight-hour period. 20 Six, in September of 2011, 21 President Obama ordered EPA administrator to 22 withdraw the proposed revision to the ambient

### 202-234-4433 Neal R. Gross & Co., Inc. Page 205 1 air quality standard for ozone. This provides 2 a unique opportunity to identify alternative

3 forms for the human health standard. 4 The alternative approach such as a 5 cumulative exposure index, may be more 6 appropriate to protect human health than the 7 current form of the standard. Thank you. 8 DR. SAMET: Okay, thank you. 9 Questions or comments? Yes, Fred? 10 DR. MILLER: Milan, I'm curious at 11 your number two point in your written 12 comments. It's statistically valid to look at 13 the trend for an individual in clean air and 14 then form the difference at what they do in 15 ozone. So I do not accept as a statistician 16 your feeling that this is an inappropriate 17 comparison. 18 It's the only valid way that you 19 can have the fact that you have changes in 20 clean air and you're seeing if the exposure to 21 ozone in fact makes them greater or less. So 22 I have to reject that comment that you make,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 206 1 unless you're talking about something entirely 2 different. 3 DR. HAZUCHA: No, I agree to some 4 degree. And what I was arguing here that you 5 need some additional information as well. 6 Suppose as an example, you have a subject who 7 had five percent improvement in FEV1 during 8 air exposure and zero percent change during 9 ozone exposure. By calculating the 10 differences this is presented as minus five 11 percent ozone effect. 12 On the other hand you may have 13 another subject who has zero effect in air and 14 minus five percent that come in the ozone. 15 That's a gain, minus five percent effects of 16 ozone. And I make a distinction and 17 difference between those two minus five 18 percent differences. 19 And that's why I argue that yes, 20 you can calculate differences but you also 21 need to present the data pre- to post-exposure 22 so one can evaluate better where it comes

### 202-234-4433 Neal R. Gross & Co., Inc. Page 207 1 from. 2 DR. MILLER: Okay, and that's why 3 you have 59 subjects in the clinical study 4 that they did, to allow that intersubject 5 variability and the profiles, do you in fact 6 get an overall mean response? 7 One of the things that seems, I 8 don't know how many people have commented 9 relative to the 60 part per billion and the 10 statistically significant but not biologically 11 significant, and yet nobody has bothered to 12 comment on the 42 percent increase in PMNs 13 that occurred, which is highly biologically

14 relevant. 15 Now that doesn't affect your 16 comment. I'm interjecting more. I guess it's 17 close to lunchtime maybe, I don't know. 18 DR. SAMET: Good point. Let's 19 see, other comments, questions for Milan? 20 Okay, thank you. 21 DR. HAZUCHA: Thank you. 22 DR. SAMET: So this ends the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 208 1 public comment period. I want to thank you 2 all for your comments and input both orally 3 and in writing. 4 On the agenda, we're actually up 5 to discussion of EPA charge questions. We're 6 not up to lunch yet. Sit down, Mike. 7 So this is something new that was 8 an opportunity to allow the panel to look 9 across the charge questions that we've been 10 given by the Agency that we've shaped our 11 discussions around, and our letter will be 12 around those, to make certain that something 13 has not been overlooked or forgotten that we 14 want to make certain to talk about while we're

15 here. 16 So clearly the charge questions 17 guide us through the document and touch on all 18 the issues, but there might be points that are 19 neglected for a chapter or perhaps come out of 20 the totality of the document that we need to 21 discuss. 22 So this is really an opportunity

### 202-234-4433 Neal R. Gross & Co., Inc. Page 209 1 for the panel to raise such issues and we'll 2 add them to our work. So let me hear if there

3 are comments. 4 Judy? 5 DR. GRAHAM: I put that question 6 on two categories. One category is there's 7 some issues that flow through several of the 8 chapters that I read that could be discussed 9 old versus new as opposed to saying something 10 about it for every chapter. So that might be 11 conservative of our time. There might be 12 other things that cross-cut many chapters. 13 And the other issue is that it, 14 and I'll be honest with you, it pains me to 15 bring it up. But I think that this document 16 has not received sufficient external input and 17 review prior to giving it to CASAC.

18 And I made that comment before. I 19 didn't make it into the microphone, it was in 20 writing, and it was because it was too painful 21 for me to say that because of the respect, and 22 I will add, and the affection that I feel for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 210 1 a lot of the authors. So this is no 2 disrespect. It is an honest acceptance. 3 I mean I know my limitations, and 4 if I got you a cast of experts in ozone 5 inhalation toxicology there would be more than 6 me sitting here. 7 So I offer this as just a general 8 comment that gives me a lot of concern. And 9 some of the individual specific comments I 10 have I think are a reflection of some of the, 11 you know, classical ozone experts not being 12 included in the review. So those would be my 13 two categories to raise here. 14 DR. SAMET: Well, there's a number 15 of comments. I mean some from panel members 16 and I think actually some from our public 17 commenters about the authorship and so on. 18 If these are general issues that 19 we think should be discussed, the nature of 20 the review, then we should bring them up here. 21 And I think you're sort of cutting at that. 22 I mean and then that said of course, there's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 211 1 such a limited time period that to begin to 2 add in layers of review becomes very, very 3 difficult. 4 And we are the ultimate peer 5 reviewers here so I think we have to remember 6 that. So that's a process question in part 7 that we might come back to. Others? Anything

8 else? 9 Again, I'll just push this since 10 we haven't done this before and I think we 11 have to feel our way through what is the right 12 kind of thing to bring up here. I see hungry 13 people. Joe? 14 DR. BRAIN: I still would like to 15 see a little more about adaptation which seems 16 to be so important to ozone toxicology. And 17 it seems to me there may be a big difference 18 in the population of our routinely exposed to 19 higher levels of ozone and then a peak might 20 mean much less to them than to a totally naive 21 population. 22 So in terms of really estimating

### 202-234-4433 Neal R. Gross & Co., Inc. Page 212 1 risk and how people respond I look for it, and 2 it seems to me that's a topic that's still in 3 my mind deserves a little more attention. 4 DR. SAMET: So we should think 5 about that. And I guess that's one that 6 potentially gets at the quote "at risk" 7 populations or less at risk and so on, but it 8 also would have to draw on the underlying 9 phenomenon, what comes out of the -- 10 DR. BRAIN: So population should 11 rarely see ozone and then see a lot of it 12 there at greater risk than people who 13 routinely see it. 14 DR. SAMET: Okay, so we need to 15 tuck that one away to think about. Anything

16 else?

17 DR. MILLER: I'll add to that the 18 aspects of attenuation, because it really 19 bothers me that we talk about attenuation and 20 the pulmonary function changes that you can 21 see in humans repeatedly exposed and you can 22 duplicate it in animals, and yet when you then

### 202-234-4433 Neal R. Gross & Co., Inc. Page 213 1 open up the animals while the pulmonary 2 function changes attenuated, the lesions 3 continued to increase. 4 And so attenuation is in my view a 5 false negative. And I don't think there's 6 enough discussion of the net synthesis 7 interpretation of what attenuation impacts are 8 in this document. 9 DR. SAMET: Okay. All right. 10 DR. BRAIN: Maybe related to that, 11 you know, what is the, are we spending too 12 much time worrying about small changes in 13 pulmonary function and not worrying enough 14 about inflammation which has, and remodeling. 15 Things that are admittedly harder to measure 16 but are probably much more related to real 17 disease, real consequences. 18 DR. SAMET: Okay. Well, we're up 19 to five after which is the official lunchtime. 20 I'm noting that we're behind because we should 21 have done Charge Question 1, but we had I 22 think a lengthy and valuable discussion with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 214 1 the public speakers. 2 So we will reconvene at 1:00. I 3 think we have time this afternoon to do our 4 work. So I think lunch for the panel is in 5 the Raleigh Room. 6 (Whereupon, the foregoing matter 7 went off the record at 12:06 p.m. and resumed 8 at 1:02 p.m.)

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### 202-234-4433 Neal R. Gross & Co., Inc. Page 215 1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 1:02 p.m. 3 DR. SAMET: Okay. We're going to 4 resume. If everybody could take your seats. 5 Okay. Pretend it's 11:40 a.m., and we're 6 going to start with Atmospheric Chemistry and 7 Ambient Concentrations. And obviously a lot 8 to discuss on this issue. So Daniel, you're

9 the lead here. 10 DR. JACOB: All right. Thanks, 11 Jon. Yes, there's a lot to discuss. And 12 probably we should spend most of our time 13 discussing those PRB issues, which were the 14 topic of half of the public comments this 15 morning. 16 And some very good points were 17 made this morning. You got my preliminary 18 comments. I have a few pages of scientific 19 issues, which are generally pretty minor. 20 Overall I think the chapter is 21 really very good. Let me focus my remarks on 22 two things. The preliminary comments I made,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 216 1 some of the comments have to do with PRB, but

2 most don't. 3 But we should talk mostly about 4 PRB. One issue about that I would like to 5 bring up too, is there's really very little 6 discussion in this chapter on long term trends 7 in ozone. And I think that this is sorely 8 lacking. 9 Analysis of long term trends of 10 ozone in the U.S. is critical if we're going 11 to look at accountability of past emission 12 strategies. If we're going to look at long 13 term influences in background, for example 14 Asian influence and what not. If we're going 15 to look at the effect of climate change on

16 ozone. 17 And it's not like we're lacking 18 literature on the subject. There's a lot of 19 observationally based literature on long term 20 trends in ozone. And that's not reflected in 21 this chapter. 22 But there's a section, 3.6.3 I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 217 1 think, on the long term ozone trends, but it 2 basically just cites a few EPA reports and 3 then the Cooper paper. But there's a whole

4 lot more. 5 And in particular, there's a lot 6 of interest in the spatial distribution of the 7 ozone trend. The ozone has been going down in 8 California and the East. Well, what about in 9 the intermountain west. And clearly some 10 discussion of this is needed. 11 Okay. I would like to talk a 12 little bit about this PRB issue, or North 13 American Background, which is Section 3.4 of 14 the chapter. 15 And overall I thought that it was 16 very well written and well balanced, which is 17 not to say that it's perfect. And I made a 18 number of comments on it. And we heard some 19 more comments this morning. 20 I would like to pick on some of 21 the comments made this morning as issues that 22 need some attention in that section. And one

### 202-234-4433 Neal R. Gross & Co., Inc. Page 218 1 is the inability of current models to 2 reproduce the high extremes of observed ozone 3 concentrations. 4 And this is critical because we 5 need models to quantify background ozone. But 6 we are very interested in the high extremes in 7 terms of relevance to the NAAQS. 8 And then the issue is, well, can 9 you count on models to get the high extremes? 10 In other words, can you prove models in a way 11 that you will be able to capture the high

12 extremes? 13 And then that gets you into issues 14 of variability of emissions, you know. Or, 15 you know, when we make generalization about 16 emissions from fires, about emissions from 17 lightening and so on. We're not going to 18 capture the high extremes. 19 And then of course the meteorology 20 in our models tend to be always adverse to 21 some extent. I mean, models in general will 22 tend to smooth out extremes in the Eulerian

### 202-234-4433 Neal R. Gross & Co., Inc. Page 219 1 models. 2 And so at some point one might 3 need to give up and go to more of an 4 observationally based analysis in order to 5 account for the high extremes in the 6 observations and the contribution from the 7 background. With regard to the different 8 factors contributing to the background in the 9 United States. 10 So we're talking about the 11 stratosphere. We're talking about lightening, 12 fires, intercontinental pollution transport. 13 All of this was very well treated. I thought 14 that the chapter was a bit uncritical when it 15 comes to the contribution from fires. 16 In particular, it was a given that 17 fires would increase ozone in the west. Well, 18 there's some studies that show that that's not 19 the case. And more, better coverage of the 20 literature could be in order. 21 There's issues about soil 22 emissions of nitrogen oxides in the U.S. Very

### 202-234-4433 Neal R. Gross & Co., Inc. Page 220 1 uncertain. The role of agricultural activity 2 may be subtle, maybe it's not clear how will 3 you include this in a specification of a 4 background. Some more discussion of this 5 would be in order. 6 One final point about the 7 background. We've lamented for some time that 8 we only had one model that was providing 9 background estimates. A very good model I 10 should say. But just one model nevertheless. 11 But that's not the case anymore. 12 We now have a few different papers that are in 13 press at least, and may be on the verge of 14 being published, that have estimates of the 15 ozone background. 16 We heard from Chris Emery about 17 the Environ study. There's also a study by 18 Arlene Fiore at GFDL. I understand that those 19 papers were not in press at the time, whereas 20 the second draft was put together. But maybe 21 they could be included in the next iteration. 22 That's about all really that I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 221 1 wanted to say at this point. Maybe Ted and 2 George and David have other points to make. 3 DR. SAMET: I guess, Ted, you're 4 next on the list. 5 DR. RUSSELL: Yes, thank you. 6 First I want to reiterate some of Daniel's 7 comments, in that I think you should look at, 8 sort of, more varieties of models. 9 And in particular you've got all 10 these new studies that have been done, that 11 are now available using different models. And 12 I think that in the next version you really 13 have to go through those critically to come up 14 with your best estimates, your best approaches 15 to treating the background levels. 16 And in particular I think what, 17 and I think I said this last time, is it would 18 be good to come up with an objective way to 19 treat the model bias and uncertainties before 20 going to the next step of the policy end. You 21 know, how to treat bias is more of a science 22 issue, not a policy issue.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 222 1 So I think it would be good to 2 have that approach laid out beforehand. I 3 mean, for one that will get away from the 4 issue of it looking like it's, that the 5 approach is to reach a certain end point. 6 So I think, you know, look at the 7 biases in the various models and how you can 8 use the more recent modeling to assess what 9 the bias might be. And also then look at the 10 variability issues. 11 As Daniel and I were talking over 12 lunch. There are a number of things that make 13 it so the models are not going to be as 14 responsive, or show the same range as the 15 observations do. 16 Just because you're using averaged 17 emissions, average, you know, sort of, you're 18 using meteorological models that do not pick 19 up the very small scale, or small in terms of 20 tens of kilometer scale effects of the 21 meteorology. 22 Those are just going to be lost.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 223 1 So you're going to be losing the extremes. 2 Just have a way to essentially approach that 3 before going to the policy analysis phase. 4 Daniel brought up the idea of long 5 term trends. I think it would be important, 6 you know, what I was sort of hoping to see in 7 this one was looking at sort of frequency 8 distributions of ozone, in terms of the mean, 9 as well as something like a standard deviation 10 or whatever, range over time. 11 Maybe it would be, you know, I 12 could see frequency plots by, you know, 1990, 13 1995, 2000, et cetera. So that you can see 14 how the mean is adjusting to the controls, as 15 well as the distribution. Because you're 16 going to be seeing, and I think I saw a table 17 along these lines, that the lower end is going 18 to start coming up. 19 And I think it has real 20 implications when we start looking at how 21 you're going to develop your quadratic 22 rollback model. And that you're going to have

### 202-234-4433 Neal R. Gross & Co., Inc. Page 224 1 to assess how that bottom end is responding to 2 controls just as well as the top end. So I 3 think that should be some focus in the future

4 ISA. 5 You know, one of the things, you 6 look at the number of observations that are 7 below eight hour maximum observations, below 8 40, 40 to 60, et cetera, 60 to 80, greater 9 than 80, just to see how those are responding. 10 That also brings up the point, is that many of 11 the figures in some of the analysis are for 12 things like the mean eight hour. 13 And I think you really should, 14 almost everything should be focusing, well, 15 maybe not everything, but on your three year 16 average of the fourth highest ozone. 17 Essentially something equivalent to what 18 you're going to be looking at is the form of

19 the standard. 20 Figure 3-58b looks wrong. I'll 21 just put that out as somehow the area doesn't 22 look like it's still conserving towards one.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 225 1 I could be wrong.

2 You made a comment about the model 3 performance for ozone deposition. Looks good. 4 You know, it made me wonder how that is. 5 Because I don't think you're measuring ozone 6 deposition. 7 And the Section 3.9., well, 3.9 8 where it's what's currently being done with 9 the GEOS-Chem modeling of analysis that's 10 underway. I thought that section was weak. 11 Not nearly so good as -- 12 DR. VANDENBERG: Ted, sorry to 13 interrupt. That section is gone, that's what

14 I understand. 15 DR. RUSSELL: Is it gone? Oh, 16 sorry about that. I missed your first part. 17 Never mind it being weak then. I missed the 18 first part. 19 But I will say just, there's one 20 thing that comes from that that, and I see 21 this all the time, is that there's a tendency 22 to say, this is important, this is important,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 226 1 this is important. And you have about ten 2 different things that are important. How 3 important? 4 You know, some of those, and given 5 that that section's gone I'm not sure if it's 6 in the other sections. But if you're going to 7 say it's important I want a context of how 8 important it is. 9 Because I don't think some of 10 those things are really that important. But 11 people always say they're important. Because 12 that way it sounds better. 13 And then, I think I said this 14 earlier, do provide some more discussion and 15 analysis of using finer scale models. And 16 what that whole, you know, what going to a 17 finer scale is really going to buy you. 18 Because, you know, at some point I 19 don't think it buys you as much as people like 20 to think it's going to. But it does get you 21 somewhere. But I think you have to be 22 cautious about how much further it gets you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 227 1 And it would be good to actually 2 have an idea of that so if nothing else, 3 people won't keep saying, well if you used a 4 finer scale model. Because I don't think that 5 get's you as much as, that's not really the 6 reason for some of the issue's you're seeing. 7 DR. SAMET: Okay. George. 8 MR. ALLEN: Well, I certainly 9 cannot disagree with Daniel and Ted. Although 10 I'm not a modeler, I agree with that. I also 11 want to join in on the trends bandwagon. They 12 are important. 13 And they're, of course there's 14 different kinds of trends. There's the 15 classic design value trend, you know, the 16 fourth highest, you know, third year average. 17 There's a mean, you know, 18 literally the annual mean or seasonal mean. 19 There are trends of precursors as well, not 20 just ozone. I think they all fit in. 21 And actually, commenting on the 22 mean, which Ted mentioned. One of the recent

### 202-234-4433 Neal R. Gross & Co., Inc. Page 228 1 papers by Zanobetti and Schwartz on ozone 2 mortality actually did use a mean metric 3 because it was a chronic study, not a time 4 series acute study. 5 And so there's an example, to the 6 extent that you accept that study with its 7 limitations, that the mean is potentially a 8 useful metric. 9 So, excuse me, but in many cases, 10 getting back to, I want to call it PRB. But 11 now I'm going to call it NABO. Okay, you 12 heard it here first, North American Background 13 Ozone, NABO, okay. Since PRB is out of style. 14 It would be interesting in some of 15 these assessments that we've heard, to look at 16 those, for that head data and similar area 17 situations. 18 We have, you know, one hour maxes 19 and other metrics. We don't have the so 20 called design value metric, which when you're 21 talking about in a max framework, that to me 22 at least is the most informative.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 229 1 And from a science point, sure you 2 want the one hour peaks. You want other 3 metrics. But when you're talking about how it 4 might impact any decision process on the max. 5 And you can argue whether it should or 6 shouldn't. That's a whole other argument. 7 But there, the classic design 8 value calculation might be more useful. 9 Excuse me, some general, excuse me, I'm 10 getting over quite a cold here. But I'm no 11 longer infectious. So Ted, you can relax. 12 I really like the revisions to the 13 front of the document. The Executive Summary, 14 the integrated summary, Section 2. And as 15 noted, it does make the bigger picture much 16 more accessible. And it's not just to the 17 public. It's actually to, at least I'll speak 18 for myself, potentially members of CASAC. 19 Everyone who's read the entire ISA 20 draft from front to finish, please raise their 21 hand. Okay. And Vanessa, I don't think we 22 want to pay us to read the whole thing, except

### 202-234-4433 Neal R. Gross & Co., Inc. Page 230 1 maybe for Jon. We generally tend to focus in 2 on sections of expertise or of interest. 3 And this up front synthesis has 4 real value to panel members who can't or 5 shouldn't or, you know, read the entire 6 document. Most of us have expertise that is, 7 you know, not just one part of the section. 8 Even though I was assigned Chapter 9 3, you know, I pretend to know something about 10 exposure assessment and that sort of thing. 11 And it's good to have that. That's a 12 wonderful format. And I hope, personally I 13 hope that can be a model for other ISAs as we 14 go through them. 15 I think we talked about that in 16 the lead review, if I recall right, directly, 17 that same sort of thing. So this is great. 18 This is really helpful, not just to the 19 public, but to myself as a panel member. 20 Now again, I'm going to focus the 21 rest of my comments on Chapter 3. Overall, I 22 think it's substantially improved over the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 231 1 first draft. 2 And, you know, there were a lot of 3 good comments that were incorporated and 4 appear as changes in this revision. Including 5 put a lot of the more detailed material back

6 toward the end. 7 Although I guess there's a little 8 less detail now that Daniel's material has 9 been removed. But that makes it much more

10 readable. 11 And readability is key here. 12 Because if it's hard to read folks are going 13 either not read it, or just have a hard time 14 reading it. 15 A couple broad, well, comments. 16 It shows up in here with reference to these 17 high winter ozone and these gas fields in 18 Wyoming. And now in the Uinta Valley in 19 eastern Utah it's the same thing.

20 Now we have the reference of 21 Schnell for the Wyoming Green River Basin. 22 And I don't think there's any papers out yet

### 202-234-4433 Neal R. Gross & Co., Inc. Page 232 1 on the Uinta. But it's the same thing. And 2 they have 140 ppb one hour max in January. 3 And there's probably more of those 4 out there. We just haven't done, you don't, 5 wouldn't normally monitor in those places. 6 But, so first of all a little sidebar, but I 7 think that's worth, from a, maybe we'll get to 8 that on the pad. But not monitoring network 9 design, that's something to think about. 10 But what's actually interesting 11 though that these are potentially very useful 12 case studies, where you have a very simple 13 scenario.

14 You've knocked out a lot of 15 components that you normally have to worry 16 about. Like, the biogenic component isn't 17 there. Temperature is out of the equation at 18 -10c. It's not a player. 19 You know what your sources are, 20 the precursors. They're pretty well defined. 21 They're pretty simple. You know, it's just 22 basically the fugitive emissions from the, you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 233 1 know, the gas fields. And also the NOx and 2 other emissions from the support vehicles and 3 generators and all that stuff. 4 So I think maybe we could learn 5 more about, in a simplified scenario we might, 6 if you went in and did all the detailed 7 measurements, that I can't do, but others can. 8 We might actually add to our understanding of 9 how some of these processes interact. 10 Again, it's a simplified scenario. 11 So there may be a possibility for studies of 12 opportunity there. This is kind of a sidebar. 13 One thing that might be worth noting is the 14 fracking thing. 15 I know that from listening to the 16 states in the Northeast with the Marcellus 17 Shale. Some of them that are downwind of that 18 are very concerned about what might happen to 19 their ozone concentrations as these things 20 develop in a relatively uncontrolled fashion. 21 You've got the perfect mix. You 22 know, you've got your VOCs. You've got your

### 202-234-4433 Neal R. Gross & Co., Inc. Page 234 1 NOx from the ground support vehicles and 2 generators. 3 And you go downwind 50 to 100 4 miles from these places, and there's a lot of 5 them. And they're distributed. We could have 6 a whole different ozone, kind of ozone problem 7 that is not even on the radar right now. 8 So I think that to the extent that 9 it's relevant to the discussion of where we 10 are. And I don't even know if there's much 11 literature on that. But if there isn't, there 12 will be. I think that may change the 13 landscape in some.

14 And there's a lot of these shale 15 fields. You know, there's one up in Michigan, 16 there's down in Texas, they've got the

17 Marcellus. There's several of them around the 18 country. It's not just the northeast. 19 And finally, or in general 20 comments. I keep talking about this Canadian 21 smog science assessment. In theory it was 22 supposed to be released last month.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 235 1 To the extent that it may be 2 useful to this process, Chapters 3 and 7 are 3 directly relevant to Chapter 3 here. It was 4 peer reviewed, but not in a journal context. 5 But they did have external review on it. 6 And, you know, it's out there. It 7 may or may not be of interest, or may not be 8 relevant. But if it's not out there now it 9 will be next week, because I'll call them up 10 and say, where is it? 11 All right. I won't talk about I 12 only found two typos, Vanessa. And I spent

13 about -- 14 DR. SAMET: Those you don't need 15 to go over.

16 MR. ALLEN: -- ten seconds on each 17 of them. And I won't talk about them. Okay. 18 Let's see, on Page 3.5 under pre-sources or 19 precursors. You know, this kind of gets back 20 to the trends I was talking about. 21 We have some big changes in heavy 22 duty diesel NOx emissions and controls kicking

### 202-234-4433 Neal R. Gross & Co., Inc. Page 236 1 in over the next several years, maybe the next

2 decade. 3 And my concern there is that the 4 inventories, which are in my humble opinion 5 never all that good, might become much more, 6 might become outdated more rapidly as we have 7 these rather abrupt changes in what has been 8 a fairly stable emissions scenario, once you 9 have taken into account VMTs and all that

10 other stuff. 11 But the actual emissions per mile 12 for NOx are going to get kicked way down, 13 almost to zero, as the fleet current controls,

14 as the fleet rolls over. 15 So it's kind of an analogy to the 16 NOx SIP call in 2003 that did have an effect 17 on ozone. The on road source for NOx is a big 18 chunk of the inventory. 19 DR. SAMET: George, I don't want 20 to interrupt, probably just major points if 21 you could. 22 MR. ALLEN: Okay, major points.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 237 1 All right, talked about that. NOy we need 2 more good data on that. But I think BP 3 actually is working that in the context of

4 what would have been the SOx NOx max. 5 We talked about NOx emissions 6 thinning down, but then we have EGU units with 7 CAIR or CSAPR, or your favorite transport rule 8 of the day. That further kicks down NOx. 9 Long terms trends again, the Mount 10 Washington data is out there. And what's even 11 perhaps more important here is that although 12 AIRMAP stopped, that's UNH, stopped in 2010, 13 the New Hampshire State Air Agency picked it 14 up in 2009 and is continuing that trend. And 15 so that could over time become a very valuable 16 long term elevation eastern U.S. trend 17 indicator. 18 On monitoring methods, there's 19 continuing discussion about interference 20 issues for the FEM UV monitor that's used. 21 The section summarizes those issues well. 22 But taken as a whole, I think

### 202-234-4433 Neal R. Gross & Co., Inc. Page 238 1 concerns about any positive interferences in 2 that method don't seem to be very relevant in 3 the context of compliance monitoring and 4 calculation of design values. They're fairly 5 limited. 6 And actually, overall, to put it 7 in perspective, the quality of contemporary 8 ambient ozone data are really pretty good, 9 relative to data quality for some of the other 10 NOx pollutants. 11 NO-based chemiluminescence as 12 monitors and FRMs. I think we'll see that as 13 our new FRM. And when we get to the bad 14 winter ozone monitoring sites, this section is 15 limited through 2009. 16 But with the 2011 implementation 17 of NCore and other initiatives, there's 18 probably been a substantial increase in winter 19 ozone monitoring since '09. So it might be 20 worth taking a look at that. 21 I strongly agree with the caution 22 on Page 395 about the issues of approximating

### 202-234-4433 Neal R. Gross & Co., Inc. Page 239 1 community scale exposures from what is in 2 reality a relatively sparse, despite our 1200 3 ozone monitor network, sparse relative to the 4 expected urban spatial variability. And I 5 think it's very good to have that in there. 6 We talked about multi-year trends. 7 The report says it's pretty much -- 8 DR. SAMET: So let me ask if 9 there's any other big points? 10 MR. ALLEN: Nope, nope. I can be

11 done. 12 DR. SAMET: Okay, so go big, 13 David.

14 DR. CHOCK: Yes. On the whole I 15 think the chapter is very well written. And 16 Daniel and Ted have already discussed the 17 issues very cogently. 18 And I don't really have too much 19 to comment on. Other than reemphasis of the 20 fact that models tend to under predict extreme 21 values, the upper extreme values. Therefore, 22 we need extreme caution when we are talking

### 202-234-4433 Neal R. Gross & Co., Inc. Page 240 1 about the NAB, especially at the fourth 2 highest value in a year. 3 I also have another point to make. 4 We talk about this Section 3.7.2 talks about 5 the fine scale modeling. We also talk about 6 the model errors being due to lesser 7 emissions, meteorology, et cetera. 8 But there is one important point 9 that almost has never been discussed. Namely, 10 the issue of subgrid chemistry. All CTMs, all 11 chemistry template model assumes uniform 12 chemical reaction within the model agree. 13 But this is true, I mean, but when 14 the time scales of some chemical reactions are 15 short, relative to the mixing time scale, the 16 constituents. Then you don't expect 17 homogeneous distribution within agree. 18 Therefore, the chemical reactions can create 19 some big problem. 20 For the atmospheric chemical 21 reaction we know that the time scales cover a 22 range of seven order of magnitude. So there

### 202-234-4433 Neal R. Gross & Co., Inc. Page 241 1 definitely, there will be errors coming in. 2 And the size of the errors, we 3 don't really know. And this is still a big 4 problem facing chemical modeling. That's all 5 I have to say. 6 DR. SAMET: Okay. So I have some 7 comments. I'll preface them by saying I'm no 8 atmospheric chemist. And my comments are not 9 going to have to do with the details at all. 10 But I really see problems with the 11 chapter as it's constructed. There is no 12 bottom line. And, in fact, isn't this chapter 13 about setting up to identify targets? Targets 14 that will be considered in the REA. And 15 targets that will become critical in the 16 policy analysis. 17 You have two ways to get to those 18 targets, observations, and we've heard about 19 the strengths and limitations of those, and 20 models. And what the chapter should do is lay 21 out, in some sort of framework, what are the 22 tools that should be used moving to the REA

### 202-234-4433 Neal R. Gross & Co., Inc. Page 242 1 and the policy analysis, and why? 2 And if you read through the 3 chapter, you go through all the details. 4 There's this model, the GEOS-Chem, whatever,

5 whatever. 6 And I understand there's strengths 7 and limitations in over prediction and under 8 prediction. But what's the decision out of 9 this?

10 What are the tools that should be 11 used? Why? How would you bring together the 12 observations data and the modeling data? How 13 does one cross validate with the other? 14 So I don't see this, I see this 15 chapter as laying out a lot of stuff, but not 16 really coming to the bottom line that is

17 needed. 18 If you look at the in sections, 19 it's sort of unsatisfactory. It's like a long 20 story without an end. So I, and having heard 21 that we're moving to "total ozone risk", it 22 only concerns me more that this chapter is not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 243 1 laying the groundwork for actually saying how 2 you get to where you want to be in the REA and 3 policy. 4 So now I'm going to turn back to 5 maybe you and the others to reflect on what 6 I've said. Because I think what you've done 7 is, you've sort of critiqued the scientific

8 methods. 9 But I think this chapter needs to 10 get somewhere. And right now, I'll be blunt, 11 I don't think it's getting, I don't really 12 think it's getting anywhere. So that's just 13 to get you thinking. Kathy. 14 DR. WEATHERS: Yes. I'd like to 15 add to that in thinking about the use of 16 models downstream. So the next step will be 17 fusion of all kinds of models, spatial, 18 temporal models, process models. 19 And I think this chapter could be 20 used to lay out those tools and methodology 21 with an eye toward all the other models that 22 will be combined in this ISA as well. Whether

### 202-234-4433 Neal R. Gross & Co., Inc. Page 244 1 it's ecosystem models, whether it's CMAQ 2 model, that will be extrapolated spatially. 3 So I agree. 4 DR. MILLER: Jon, in view of your 5 comments I have a procedural question. And 6 that is, are you going to ask for each of 7 these chapters, if the people are willing to 8 sign off saying that, if their comments are 9 addressed? Or, you know, are we going to 10 identify chapters that need to come back a 11 third time, et cetera? 12 Because, you know, from the thrust 13 of your questions, and I know that it exists 14 for some other chapters, there's still some 15 major work to be done. 16 DR. SAMET: Okay, I guess you're 17 sort of alluding to the fact that John 18 optimistically, or not optimistically, 19 proposed that there would be a completion of 20 the draft over the next couple of months. And 21 I guess the question that we'll have to come 22 back to is, how important are the gaps that we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 245 1 still see, or the needs for change. 2 I would like to hear actually 3 from, perhaps on the atmospheric scientist 4 side, just on my thoughts about this. And I'm 5 obviously thinking sort of what the product is 6 that has to come out of this chapter and 7 whether we're there. And then maybe, Daniel, 8 then you could comment. And perhaps we should 9 hear a little bit from John. 10 DR. JACOB: Well, your comment is 11 interesting. Because it's a question of 12 whether this simply has to be an assessment on 13 the state of the science, or whether it should 14 go into recommendations for good practices 15 going ahead. 16 My understanding was that it was 17 intended to simply provide a critical survey 18 of the state of the science. Now, what you're 19 suggesting is that it should go beyond that. 20 Do the other chapters go beyond 21 that? I'm also a primary reviewer for Chapter 22 10. It doesn't go beyond simply going through

### 202-234-4433 Neal R. Gross & Co., Inc. Page 246 1 the lay of the land of the science. So I'm 2 interested in your perspective on that. 3 DR. SAMET: So I mean, I would 4 actually, you know, just think about this. I 5 would actually sort of make the analogy to, 6 for example, the bottom line is on the health 7 data and causal influence, which is providing 8 something to move forward on. 9 You know, that for the risk and 10 exposure analysis you move forward with those 11 that are in the, you know, we've had a lot of 12 discussion that are causal, that are likely to

13 be causal. 14 And these are the ones you hone in 15 on. That here there should be perhaps enough 16 explicit guidance that perhaps the choices are 17 clear enough moving forward, that the 18 document, you can turn back and across this 19 whole trail from ISA to REA to policy 20 analysis. 21 It's clear why decisions have been 22 made, why a particular model is used, and how

### 202-234-4433 Neal R. Gross & Co., Inc. Page 247 1 it's used. And what the inputs are in the 2 REA. So it seems to me that's what should be, 3 this chapter should be setting up, which at 4 least for me, there should be a more 5 definitive kind of bottom line coming out of 6 the chapter, beyond its survey elements, which 7 it certainly, you know, which it certainly 8 does. So Helen, is that a hand up?

9 DR. SUH: Yes. That was a 10 tentative hand up. But this goes into some 11 comments I was going to say about the next 12 chapter. And I think also just to help put 13 what I think is the ISA. 14 I agree it's really a summary 15 and/or synthesis of what the findings are. 16 But within there, what I found was lacking in 17 this version, was really the synthesis part. 18 And so, I think, for example, 19 Chapter 4 and maybe Chapter 3, does a good job 20 of summarizing what is known. But the idea of 21 carrying it through to the other sections I 22 think is what's missing.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 248 1 And so I think the reason you want 2 that is because it does tie, it does help you 3 come back to the REA and the policy

4 assessment. 5 And when you turn to think about 6 interpreting the results and what do they mean 7 and the weight of evidences. So, for example, 8 like I know from the exposure side, you know, 9 they'll talk about things like exposure air or 10 confounding. 11 But then it's not discussed in the 12 chapters about health. And it's not discussed 13 in the chapters of the summary, in terms of 14 like, well, how does that help you, you know, 15 understand what's going on in the health

16 results? 17 Or how does that even carry 18 through in terms of from the concentration? 19 What I thought was interesting is that from 20 Chapter 3 to Chapter 4 there was really no 21 tie. And that to me, there should be a tie. 22 Because, you know, Chapter 4 with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 249 1 exposures was talking a lot about using 2 ambient concentrations to relate to exposures. 3 But there really wasn't a tie to, you know, 4 where there could have been a tie, there 5 wasn't a tie to, you know, pertinent parts of 6 Chapter 3. And I think that would have helped 7 make Chapter 4 better, or better synthesis. 8 So I think that might sort of help with this. 9 DR. SAMET: Yes, Daniel. 10 DR. JACOB: Just with regard to 11 the whole background issue. And I think it's 12 a point that was brought up by John Jansen 13 this morning. 14 There's an important review paper 15 by McDonald-Buller which talks about the state 16 of the science and PRB estimates, and provides 17 recommendations for forging ahead. 18 And, you know, I had a comment 19 about this on the chapter. But clearly that 20 should be brought into the chapter. Because 21 it does provide some, a road ahead as you say. 22 But there's another thing, which I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 250 1 think is what you touched on, which is that 2 this chapter also needs then to provide better 3 justification for what is being used in the 4 REA and the policy assessment. And that took

5 note of that. 6 DR. SAMET: Clearly this is one of 7 the more critical elements. And, you know, we 8 heard a lot of discussion from the public 9 comment, as we heard before about the 10 complexities here. 11 And I'm just trying to think how 12 this chapter sets up as a foundation for what 13 is to -- Paul or John, this might be a good 14 time if you want to comment. 15 DR. VANDENBERG: Yes, thank you. 16 These comments are all helpful. And I think 17 they're actually not a big surprise. One of 18 the things that we're doing here, and I think 19 you're all reflecting on that, is this is the 20 foundational information that then serves as 21 the basis for many decisions. And there are 22 a lot in the risk and exposure assessment,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 251 1 which you'll review subsequently. 2 So it's a question of what do you 3 put here? What do you put there? And what we 4 have elected to do here is to not draw 5 prescriptive, you know, use this, not that. 6 But we certainly welcome your 7 input on that. If you've got a view that we 8 can feel confident drawing a conclusion about 9 one approach versus another, certainly we 10 welcome that kind of input. 11 But we have, in the first draft 12 and now in this draft, we have tended to shy 13 a little bit away from that, given what I'm 14 hearing here, compared to where we could go in 15 terms of drawing more guidance ultimately for 16 the risk and exposure assessment. 17 As it is now, the anticipation is 18 that in the risk and exposure assessment, 19 you'll see many of those judgments and the 20 basis for the judgments portrayed. 21 You don't have that now, you know. 22 So that's one of the challenges here. So I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 252 1 don't know if that helps. But we certainly 2 seek your comments and suggestions. 3 This does raise the question, as 4 you note, about my optimistic view of this is 5 a second draft moving toward a final document. 6 And I think that one of the judgments that 7 we're looking for is whether this foundational 8 approach may be going somewhat beyond that, is 9 going to be sufficient. 10 Or whether we need to have yet 11 another draft, which we have not planned for. 12 But that's, you know, where your input is very 13 helpful to us. 14 DR. SAMET: Now one comment, just 15 in terms of sort of symmetry with many of the 16 other. At least with the components directed 17 towards the other part of the REA, the 18 concentration response and the causal 19 determinations.

20 There are sort of useful bottom 21 line findings coming out of those chapters, in 22 terms of moving forward. I mean, I think at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 253 1 the minimum there has to be a far more 2 synthetic discussion at the end of this 3 chapter. I mean, it just doesn't really end. 4 And I think it has to. 5 I mean, you can, in terms of this 6 process of moving from ISA to REA, you're 7 going to have to decide by precedent, you 8 know, what sort of bottom lines are reached in 9 the ISA versus what goes into the REA. 10 But it seems to me that here 11 you've done an evaluation of this body of 12 concentration data, and then some important 13 tools. And you ought to be able to come to 14 some judgment as to their relative utility in 15 moving forward. 16 And that then is setting up. You 17 know, maybe you're not specifying details in 18 model parameters or whatever. But that there 19 should be something that lays a, I think some 20 sort of foundation, that's a little more, that 21 is more than what is here. But I think I'd 22 like to hear from others on this point.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 254 1 Kathy. 2 DR. FREY: Well I think part of 3 the state of the science is merging some of 4 these tools. What's the fusion between again 5 some of the processed based models and 6 empirical studies? 7 And that might be a way to make 8 that shift, by evaluating the state of the 9 science of making those linkages. And that's 10 the integrated part. 11 I think it largely would be used 12 in terms of policy. But it's also used in 13 terms of pushing the science forward. So that 14 may be a way to do it.

15 DR. SAMET: Fred. 16 DR. MILLER: Well, I think this is 17 an area that Dr. McClellan in his written 18 comments, addressed about the need to have 19 this bridge between the science and judgment, 20 not just in the REA and that. 21 And so the question to me comes 22 back, are the air quality people at OAQPS, as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 255 1 a collective group, prepared to defend what 2 they do? 3 As opposed to having the experts 4 that are on this panel providing guidance to 5 say, this kind of collectively, from our 6 experience in the field, is the kinds of 7 methods and tools that you ought to be using. 8 And so where at that point do you 9 put the judgment part in? And he's certainly 10 arguing that you do it earlier in the ISA. As

11 has been done for some of the health effects 12 and the other kinds of things. 13 So is it restricted only to the 14 health effects and the atmospheric chemistry? 15 Is it whatever you come up with? Or does it, 16 in fact, benefit from the pool of experts here 17 providing initial perspective of what are some

18 of the better tools to use? 19 DR. SAMET: Okay. I think the 20 point's made. I just want to see if any of 21 the other -- Ted, do you have a comment here?

22 He's sort of a CASAC veteran.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 256 1 DR. RUSSELL: No, no, I'm not 2 asleep. I got in, I just flew in from 3 Auckland so things are a little off kilter. 4 But, I mean, it would be different from the 5 prior CASAC reports. I mean, in terms of the 6 form of this chapter, to have somewhat more 7 integrative. 8 I think some of my comments were 9 sort of along those lines, in that I do think 10 it is part of the ISA that you should provide 11 an objective approach to how you deal with 12 biases in the models. 13 And they should provide the 14 information in terms of how to interpret the 15 trends with the idea that, I mean, we know 16 what's coming down the road is they're going 17 to have this quadratic rollback, or some sort 18 of a rollback model. We know that's going to

19 be there. 20 But we don't have the information 21 in this chapter yet to see how the science is 22 going to inform the parameters in those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 257 1 models. So I think those should be here. 2 And also I think one of the other 3 things, I forgot to bring it up, that should 4 be here, that I think is going to be 5 important, is how you adjust between various 6 metrics of ozone metrics. And how those long 7 terms trends in those metrics. 8 I do actually, it would be 9 different, but I like the idea that this 10 chapter would be much more prescriptive in how 11 you would inform those pieces of the REA that 12 we know are coming down the pike. 13 And in particular, you know, how 14 you're going to use the model results to 15 define background, whatever that is, to set up 16 the parameters of the rollback model. And how 17 you're going to provide the information to

18 BenMAP and APEX. 19 And those things really aren't 20 here yet. And I think that would be a good 21 part of this. And we have argued for that

22 before.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 258 1 DR. SAMET: Okay. Thank you. 2 It's useful to remember that the `I' stands 3 for integrated. So, let's see. Any other 4 comments? John, any further thoughts that you 5 would like to -- 6 DR. VANDENBERG: I think that's 7 good for now. I may come back to this later. 8 Actually, if I could, the one comment was made 9 about some of the newer publications that came 10 out since this draft was created. 11 And in the past CASAC has provided 12 some very specific suggestions about new 13 studies, new models, whatever, that have come 14 out since that draft. That's always very 15 helpful for us if that sort of conclusion is 16 drawn by the group. Because otherwise we tend 17 to view that as an essential element to 18 bringing new studies into the ISA at this 19 point. 20 DR. SAMET: Okay, then moving 21 right along. Chapter 4, Helen. 22 DR. SUH: Okay, so touched a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 259 1 little bit about some of the overarching 2 comments. But I might repeat myself, which

3 I'm known to do. 4 So, first of all, I think Chapter 5 4 is a substantial improvement over what had 6 been presented prior. I think it's an 7 improvement both in terms of the clarity of 8 the presentation, and I think on the emphasis 9 on what's important. And also on the 10 presentation of the facts. You know, what is 11 it that we know about ozone exposures? So I 12 think that was a really good job. 13 I also -- harking back to 14 something Judy's always talked about, is 15 really thinking about, talking about what is 16 new since the last review. I think the 17 chapter did a good job with that as well. 18 I think the chapter could benefit 19 -- I mean, I think a lot of the discussion was 20 over short term ozone and it's relationship 21 with, you know, ambient concentrations, and 22 also with other pollutants and co-pollutants.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 260 1 And I understand why that is, that 2 emphasis is there. That's what the data is 3 like. The data focuses on 24 hours or maybe

4 an hour. 5 But I think given the standard and 6 given some of the health chapters and emphasis 7 there, I think it would be useful, even in the 8 absence of data, to talk a little bit maybe 9 about what the possible implications are for 10 longer term effects. Or if there are data 11 that could be used, you know, what we might 12 think about in terms of longer term ozone 13 impacts, its relationship to ambient 14 concentrations as well as to other pollutants. 15 So I don't know if that's maybe 16 through maybe some modeling. Taking some, 17 maybe some stuff from APEX. I don't know if 18 that's what it is. Or I don't know if it's 19 trying to request data from -- like, for 20 example, I could give you a lot of the 21 personal exposure data, and you could use, you 22 know, recalculate longer term estimates and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 261 1 see how that changes. So I know that wouldn't 2 be peer reviewed. But maybe there's some way 3 to think about that. If not now, then maybe 4 in the REA, and have a place holder here to 5 mention that, just that you're thinking about 6 it. I think that would be great. 7 I think, there are a couple of 8 sections I found somewhat confusing. One was 9 on the simulations using the APEX model and 10 how it's used, basically looking at exposures 11 from just meeting certain design values. 12 I thought that was -- I don't 13 know, that seemed more like belonging to the 14 REA versus belonging to the ISA. I found it 15 misplaced. 16 And I don't know if it's because 17 of the way it was presented. Because it 18 talked a lot about, you know, those 19 assessments from REAs in the past. And I 20 thought that was, 1) not conventional. That's 21 not typically done in an ISA. 2) I don't even 22 know if that's even considered peer reviewed.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 262 1 Maybe it is, I don't know. And then 3) that 2 kind of analysis seems not really appropriate 3 for this part. 4 The other section that I found 5 confusing was the section talking about -- I 6 think it's 4.4.3, which is the population 7 proximity to ozone monitors. This was where 8 I thought a great tie in to Chapter 3 could be 9 possible. Because first of all, I think it's 10 not even clear that population proximity to 11 ozone monitors is important, right? Because 12 in urban settings people living near roadways, 13 you're going to see reduced concentrations, as 14 discussed in the other chapter.

15 And then -- so whether or not -- 16 and that variation occurs over much smaller 17 distances than the proximity to monitors that 18 you're talking about. So it seems that 19 spatial variability in ozone is much greater 20 than this population proximity that you're 21 talking about. 22 So I think that would be a poor

### 202-234-4433 Neal R. Gross & Co., Inc. Page 263 1 surrogate of exposure error, one. But 2) I 2 think you could try to use some data. Maybe 3 overlay the concentration maps that you have 4 in Chapter 3. Overlaying those concentration 5 maps on the population maps with the distance 6 to monitor. And that would be, I think, a 7 good way to tie in the results. Like a little 8 bit of synthesis. 9 And I think then it might, then it 10 would make -- first of all, it would put your 11 discussion more in terms of really what does 12 it mean in terms of concentrations. Which I 13 think is the key. 14 And then 2) I think it would say 15 whether or not it's important. Because, you 16 know, from this I was thinking, oh, I don't 17 think it's important. But I didn't have any 18 data. So it would be good to back it up with

19 data. 20 And so that kind of brings me to 21 the overarching comment which I mentioned 22 earlier. I thought the chapter was good, a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 264 1 good presentation of facts. But what I 2 missed, and I don't know if it's in this 3 chapter, and -- I missed a overall summary 4 synthesis, that I thought was going to be in 5 Chapter 2. But it was really -- Chapter 2 to 6 me was just a re-presentation of the summary 7 from each chapter. 8 And what I was looking for was 9 really, well, how does this all fit together? 10 So why do exposures matter really was missing 11 from, you know, the health effects chapter. 12 I didn't see, and even, you know, the sections 13 talking about confounding or error. They 14 didn't talk about the exposure results. They 15 talked about epi studies that had those 16 components. 17 But what I think -- you know, even 18 in the long term ozone exposures, there's, you 19 know, there's some big issues related to 20 exposure assessment there, right. And I think 21 those are well recognized big issues. And 22 they were touched upon. But it would be great

### 202-234-4433 Neal R. Gross & Co., Inc. Page 265 1 to take what you found in Chapter 3 and bring 2 it forward and bring it backwards, so that we 3 could have a synthesis. 4 Because otherwise, you know, these 5 results are interesting but, you know, why do 6 you really care? So what I think would be 7 good is to try to embed -- you know, and I 8 would argue that the Chapter 2 should be more 9 integration and less summary. I think right 10 now it's almost all summary. And I think in 11 the PM document it was more synthesis and less 12 summary. And I know that we had pushed for 13 that in the PM document. 14 And I would really push for that 15 here, too. Because I liked how you put the, 16 you know, all the up front material up front. 17 But I missed this, like this more of a 18 complete picture, which I think is really what 19 Chapter 2 should be. So I would argue for 20 that to be put there instead. So that's my

21 overall comments. 22 DR. SAMET: Okay. David.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 266 1 DR. CHOCK: I think the current 2 version of Chapter 4 is a substantial 3 improvement over the previous version. I like 4 it very much. And I don't have too many 5 issues to add. 6 One small issue is that in Table 7 4-3, you use ratio and slope interchangeably. 8 And, in fact, I don't think you should do 9 that. Because it depends on the structure of 10 your regression model used in the table. 11 Another point that is a big 12 surprise to me is in subsection 4.5.3, where 13 the chapter describes the children's exposure 14 to Los Angeles and Boston. If both cities 15 were to meet an ozone standard of 74 ppb. And 16 the point is that the 8 hour exposure above 70 17 ppb will be much greater in Boston than in Los 18 Angeles. And clearly this is a result of a 19 rollback, a quadratic rollback I suppose. 20 And I think there is really no 21 justification to show that if it would -- if 22 both cities were to meet 74 ppb standard then

### 202-234-4433 Neal R. Gross & Co., Inc. Page 267 1 the Los Angeles children would be much better 2 off. I just don't see the justification of

3 that. 4 And this could expose the problem 5 of the quadratic rollback itself. And also 6 this particular paragraph really has nothing 7 to do with the rest of the chapter. So my 8 recommendation is to have it removed. That's

9 all I have. 10 DR. SAMET: Okay. We don't have 11 comments from Ed. So let me ask if there are 12 others who want to comment on this chapter. 13 Yes, Chris.

14 DR. FREY: Not so much on the 15 Chapter 4, but I mean, maybe to follow up on 16 some of what Helen said about how this ties in 17 to the prefatory, or the front end material.

18 One of the comments I had on the 19 preamble is that, you know, it gives a nice 20 overview of the sort of general methods for 21 the ISA. But I think it fell very short on 22 exposure.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 268 1 And, you know, one of the things 2 that I think could be better connected, and 3 this might have implications for the 4 integrative summary in Chapter 2 as well, is, 5 you know, I guess the source of the hazard 6 identification and the dose response data is 7 a factor influencing the choice of exposure 8 metric. 9 And I think some discussion of 10 that interaction in general in the preamble 11 would be helpful. And then in the integrative 12 summary, something more specific to this 13 integrated science assessment would also be 14 helpful. 15 So, you know, to the extent that 16 some of the studies are based on clinical data 17 of kind of direct measurement of 18 concentration. You know, that's one kind of 19 concentration to the extent some are epi 20 studies based on fixed site area wide 21 monitors. That's a different exposure 22 surrogate. And so I think just carrying that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 269 1 through in its implications would have been 2 helpful. 3 DR. SAMET: Judy. 4 DR. GRAHAM: This chapter provides 5 a foundation for exposure being a 6 susceptibility factor or sensitivity or high 7 risk. When we get to Chapter 8, who's at 8 risk, one of the big factors is going to be 9 exposure. And so some of the concepts that 10 are here are very supportive of that. 11 Discussions of indoor and outdoor, that's 12 great. 13 One thing that didn't come through 14 is what are children's activity patterns by 15 age? So what you're seeing -- and even by 16 time of day. Because what comes up with a 17 kid, a kid is not only more biologically 18 sensitive, in terms of his developing systems. 19 The kid's going to be outdoor in 20 the height of the summer day exercising. So 21 the kid has a triple whammy. And I think 22 that, you know, the scientific foundation

### 202-234-4433 Neal R. Gross & Co., Inc. Page 270 1 needs to be here so it can be alluded to in 2 Chapter 8. 3 The other point I might bring up 4 is, Page 419 it talks about ozone averting 5 behavior. And that was mentioned earlier on 6 in one of the presentations. And the whole 7 focus is on how people may reduce their 8 exposure. So that would influence epi. It's 9 all, oh, we don't need to worry about those 10 people, you know, they've removed themselves 11 from the exposure. 12 Fine, that's one valid viewpoint. 13 Another valid endpoint, could it be an effect? 14 One of the effects of ozone is that you have 15 to alter your behavior to run away from it. 16 So I don't know the answer to that question. 17 But it's not obvious. 18 DR. SAMET: Okay. Anything else 19 on Chapter 4? Okay, go on. Chapter 5. Let's 20 see, we have the ultimate trio of ozone 21 dosimetrists here. I was just musing over how 22 many collective years of work you have on this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 271 1 issue. You made your fortune on ozone 2 dosimetry. Way to go. 3 (Laughter.) 4 Jim. 5 DR. ULTMAN: Okay. Chapter 5 -- 6 DR. SAMET: I think your mic may 7 have gone off. 8 DR. ULTMAN: I just turned it on. 9 Okay. Chapter 5 is a combination really of 10 three different things. The uptake in dose of 11 ozone, the reaction of ozone with endogenous 12 substrates once it's absorbed, and then 13 finally how that connects to the method of 14 action of ozone. 15 And I think in the original 16 chapter we criticized a lot the flow of the 17 chapter, from one of these aspects to another. 18 I think that's been really vastly improved. 19 And I think most of the other criticisms that 20 we made in the first round were met pretty 21 effectively. 22 There were a few things that I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 272 1 personally found that still could use a little 2 bit more work. And what I'll do, I'll mention 3 them kind of broadly. But I have detailed 4 comments where I specifically, in fact, insert 5 sentences and paragraphs that you might 6 consider putting in. Because it wasn't clear 7 to me that you would understand what I meant. 8 So I made it very specific. 9 But just for purposes now, one of 10 the criticisms was that there wasn't 11 explanation or definitions of some of the 12 dosimetry principles and nomenclature. At 13 least it wasn't very effective. 14 And I think there's been some 15 improvement there. But I think yet there's -- 16 still better definition of terms and 17 consistent use of terminology throughout the 18 chapter could still be improved. 19 And also dosimetry principles are 20 mentioned and then results of theoretical 21 simulations and experimental measurements are 22 mentioned. But the two aren't really very

### 202-234-4433 Neal R. Gross & Co., Inc. Page 273 1 effectively connected. 2 In other words, how did the -- at 3 least in a qualitative sense, how did the 4 principles lead to these observations or these 5 predictions? I think that could be shored up 6 a little bit. 7 Table 5-1, which I believe was 8 present in the first ISA also, is a comparison 9 of results from different kinds of experiments 10 that have been performed on humans to measure 11 ozone uptake in various regions of the lungs, 12 using various protocols. 13 And this is not an easy 14 undertaking to do it, because these 15 experiments all use different protocols. And 16 even though they all measured ozone dose, they 17 measured them in different ways. And 18 therefore, the doses that they measured meant 19 different things in a sense. And I think the 20 table has all the information there. But I 21 think it's still not crystal clear. But it's 22 not your fault. I mean, it's complicated.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 274 1 And one of the things I'm going to 2 point you to is a publication in an edited 3 monograph called "Handbook of Human 4 Toxicology" that myself and a colleague had a 5 section in, where there's a nice figure and a 6 table much like yours. You might draw some 7 additional information to help you with your 8 table. The pages in that textbook, I'll give 9 it to you in my comments. But anyway, it's 10 Page 494 to 499 you'll want to look at. 11 The third thing I wanted to 12 mention was that -- we criticized in the first 13 round, on the ISA, the fact that you talked 14 only -- or maybe too much, about the reaction 15 products being at the root cause for the 16 method of action of ozone. And I don't think 17 that's really changed very much. 18 I'm not sure that criticism is 19 important or not, personally. I think it's 20 only important to say that ozone itself, if it 21 gets through to tissue, could cause damage by 22 these means. Or, alternatively, it can form

### 202-234-4433 Neal R. Gross & Co., Inc. Page 275 1 toxic products in the ELF and those can be 2 transported further on. 3 So it's not, you know, just as 4 long as you include ozone as one of the 5 possible agents, I think it's fine. But what 6 I did find, and I thought that your coverage 7 was really good. 8 You had reaction mechanisms, you 9 had various different kinds of products. I 10 thought it was very well done, such as it is. 11 The problem is that there's no prioritization. 12 I don't know if you can do that or not. 13 But it's like you have a laundry 14 list of these different possibilities. But 15 which one might really be -- you know, which 16 one or ones might really be the most important 17 in creating the mechanism of action that you 18 talk about later in the chapter? 19 And I think if you can connect 20 that better and prioritize, it will help an 21 awful lot. Because otherwise it's just like 22 a list of chemicals. And I thought, as I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 276 1 said, coming up with that list wasn't easy. 2 And trying to support that with the various 3 kinds of mechanisms wasn't easy. 4 But I think you can go, try to go 5 one step further. I don't know if it's 6 possible or not. That's pretty much all I

7 had. 8 DR. SAMET: Okay, Fred. 9 DR. MILLER: Well, I have 12 10 points to make. And part of that's a 11 reflection that Jim is a chemical engineer 12 entered into dosimetry later in life. 13 Whereas, I sort of was maybe born there. 14 I have to agree with Jim that the 15 chapter is greatly improved. And you've done 16 a much better job of strengthening the mode of 17 action by adding results from animal studies. 18 And the way the chapter flows. And so I 19 commend you for that. 20 As far as some of the things that 21 can still be improved, I'm going to address 22 some of those. To me there's still a need to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 277 1 do some cross-linking. And this may happen 2 also in other chapters. But for example, the 3 section 5.3.7 on Airway Remodeling, there's no 4 discussion there in a link to Section 7.2.3.1, 5 which you discuss in this chapter, the adult 6 primate structural changes, but not anything 7 about the infants and neonates from the 8 primate studies in Davis that have tremendous 9 implication for children. And so I urge you 10 to, if you're not going to add more in just in 11 text, at least do more cross-linking. 12 I -- before you've improved the 13 treatment of the ELF and the acknowledgment of 14 the fact that it could be ozone. But you 15 haven't gone far enough. You went out and got 16 the Bastacky study and he's in John Clements' 17 lab. And John Clements from day one has been 18 interested in the thickness of the surfactant 19 layer. 20 It still comes across here as, 21 well, yes, it's an outside shot. The point 22 is, if you really read that study carefully,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 278 1 four percent of the surface area is less than 2 .02 microns. The median thickness is .1, 3 which means that 30 to 40 percent are only a

4 few nanometers. 5 So my statements earlier that I 6 brought up at the first round about the 7 possibility for ozone to directly react and 8 get through the epithelial layer is actually 9 improved by what you found here, not

10 decreased. 11 And so this kind of goes to what 12 Jim was saying about you kind of -- still kind 13 of lumped it all together. And so I think if 14 you pulled out some more data from that paper 15 you're going to see. And that also is a very 16 good example of why probably you see the 17 patchy external network of damage with ozone 18 exposures. 19 The difference between the areas 20 where you have very little lining and where 21 you have the more thicker, that probably 22 creates other reaction products. So that's --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 279 1 you're on the right track. And it's just, to 2 me, something that needs to be a few more

3 sentences added. 4 Relative to Table 5-1, I have to 5 point out there still is a problem here over 6 and above what Jim talked about. And that is, 7 you are mixing absorption efficiency and 8 absorption fraction. 9 Absorption efficiency is the 10 percent uptake for that amount of material 11 entering a given region. And it is only equal 12 to the absolute fractional uptake for the 13 head. For the other areas, it is not. 14 And you have some examples in your 15 nomenclature in the table where the fractional 16 uptake sums to greater than one. And it's 17 because it's really an uptake efficiency, not 18 a fractional uptake. So you need to clarify

19 that. 20 On 5-8, line 12, you make an 21 excellent point that I think should go forward 22 to the Executive Summary chapter. And this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 280 1 has to do with the variability in path link in 2 the trachea. And you point out how you could 3 have a region that might not get a high enough 4 dose. But you have other regions that can 5 within the same animal, or the same human. 6 And that, to me, is a point that 7 should go not only to the summary, but really 8 it is something that has to do with the 9 overall aspects in the population and why you 10 see some people responding more than others, 11 for example. 12 I brought up in the first review 13 the treatment of the Wiester, et al., paper, 14 as it being not included. It still wasn't 15 included. And I will again state, why isn't 16 it? Because -- has the paper been 17 discredited? Because it would require you to 18 change the material on Page 19, where you talk 19 about the ranges. Because Wiester, et al., 20 they only saw 40 percent total respiratory 21 tract uptake. And you cite others as 50 22 percent and 90 percent and so on. And so the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 281 1 paragraph there would need more refinement. 2 And this is again a reflection, 3 just species differences that can occur in the 4 overall uptake. So I'm not going to back off 5 on -- you know, either say it's been 6 discredited or it changes your text. 7 You make a statement on Page 5-9 8 that ozone dosimetry models predict low tissue 9 dose in the trachea. But injuries seen there, 10 and so maybe it's net dose that's better. 11 If that were true, then you would 12 see more effects in the tracheobronchial than 13 you see in the other regions, because that 14 dose is actually very close to what you get at 15 the central acinar region. So that paragraph 16 needs to be reworded. It just doesn't hold. 17 You also talk about the paragraphs 18 on 5-13 where you talk about nasal and oral 19 uptake. And it's probably not biologically 20 significant. I have a problem with that. And 21 you cite where there's probably not much 22 differences.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 282 1 But to me the definitive study for 2 that is one that Jim Ultman was involved in, 3 the Nodelman and Ultman publication. They 4 looked at shallow breathing and the breathing 5 level you would have with exercise. 6 And you see nasal to oral drop of 7 .9 to .8 for shallow breathing. But you see 8 a .4 uptake to .25 for exercise. That ends up 9 being a 40 percent change in dose. And so it 10 is not correct to say that nasal and oral 11 basically are the same and don't impart a 12 difference. 13 On page 5-50 you talk about the 14 definitive study on FEV1 hasn't been done. 15 And I'm getting awfully tired of hearing about 16 FEV1 and ignoring -- not, you know, from some 17 of the commenters -- the things about other 18 biological endpoints. 19 Well, yes, you state that the 20 definitive study hasn't been done. And that's 21 true. But the reason it hasn't been done is, 22 for the selection of the subjects -- and I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 283 1 pointed this out before, and you have some 2 wording in here that Overton, et al., and of 3 course I'm one of the et al.'s, pointed out 4 how if the conducting airway volume is the 5 controller of that delivered dose, and if you 6 measured that conducting airway volume on 7 every subject that you studied, you would be 8 able to do a much greater normalization and 9 sort out this variability in FEV1 in that. 10 So you allude to it, but it really 11 is a key point for understanding why we get so 12 bogged down in where we see these differences, 13 and so forth, in the variability of it. It is 14 the major player. 15 In the introductory paragraph on 16 5-68 you say that the extrapolation is going 17 to be qualitative. And it could easily be 18 quantitative. And I have to argue that if you 19 would take panel C of figure 9-6 of one of my 20 papers in 1988, where we actually solve for 21 the different species in the broncho lavage 22 fluid protein, got the tissue dose, normalized

### 202-234-4433 Neal R. Gross & Co., Inc. Page 284 1 it to body rate in that, and we see you have 2 this plot normalization across species. And 3 you could even now add on the human data. 4 And the reason is not to bring it 5 up to say you're going to do qualitative or 6 quantitative extrapolation. The point is of 7 that exercise is that it shows the importance 8 of the animal results for underpinning the 9 implications for humans. 10 And throughout it would dispel 11 this "so what" attempt to say, well, changes 12 in humans are not of concern, because, you 13 know, we're talking about 1.7 percent FEV1, 14 and if I do a different statistical model it's

15 1.2. 16 And that's fine, and that doesn't 17 mean much. But, you know, 40 percent change 18 in pmms, that does mean something. You'd 19 start to see how this massive amount of animal 20 toxicology data shows that we are not that far 21 off being able to integrate the different 22 things.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 285 1 So I would take just one endpoint. 2 And that one's already been done for you. All 3 you got to do is extract the figure -- would 4 show how this is really a homology and 5 qualitative, beyond qualitative can be 6 quantitatively. 7 And the last point that I want to 8 make is I want to re-emphasize that Section 9 5.2.7.7, which is on physical limitations, 10 could be increased in strength in two areas by 11 adding more of the discussion of the exercise, 12 which you don't. You talk about body mass 13 index and some things. In addition, the other 14 thing, this is the logical place for 15 introducing some material on the McDonnell 16 model and the FEV1 and the dynamics. Because 17 it's the perfect integration of it. 18 And I guess I would like to see it 19 there because, to me, it is a very strong 20 synthesis of the ability to then look at a 21 variety of exposure regimens. 22 And I'm reminded in the 1990's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 286 1 when you took Overton and my model and you 2 took people through time and space, a 9-year 3 old and an adult, and you compared it to the 4 monkey in that, and you were able to show the 5 importance of the animal studies, and that 6 there wasn't that much for a margin of safety. 7 And so here you have the McDonnell 8 study where you can really synthesize a number 9 of different human studies and give strength 10 to the OAQPSs using the changes that they see 11 in clinical studies and modeling that for 12 overall risk. 13 So those are my comments. I won't 14 go into the ones that require typing up of -- 15 except for please have a technical editor go 16 through and where it should -- you've used 17 which when it should be that. Just my own pet 18 peeve. 19 (Laughter.) 20 DR. SAMET: Judy. 21 DR. GRAHAM: Okay. I think there 22 needs to be more thought given to Chapters 4,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 287 1 5 and 6 as a unit. Exposure, dose, response. 2 And that all eventually gets us to sensitive 3 sub-populations, which is -- the standard will 4 eventually be based upon them. 5 So, for example, the issue of 6 children is raised on like page 5-14. And 7 there have been some studies about influence 8 of age on dosimetry. 9 Well, that's great. I think it 10 got maybe a whole paragraph. Well, kids are 11 what we care about. And the dose is right 12 smack dab in the middle of understanding about 13 kids. So how about a figure that shows the 14 age dependence of dosimetry? 15 I'm looking at Page 5-26 now on 16 mechanisms of action. First of all, thank 17 you. The previous one had more effects than 18 MOA. So you really did a good job of cleaning 19 that up. And I have some picky things, but 20 they're only picky in terms of what didn't get 21 cleaned up in that respect. 22 So my concern is that it be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 288 1 clearly understood. And so, for example, we

2 know from the whole of the document that 3 things like concentration, duration of 4 exposure, exercise are very important. 5 And in many cases the MOA studies 6 provide such information. But in some cases, 7 you don't know whether in humans, whether it 8 was exercising or not. In some cases, you 9 don't know whether it was acute or chronic. 10 So I'm not talking about five 11 hours a day, five days a week, for two weeks. 12 I'm talking about -- you can use general 13 terms, but at least to get so a reader knows 14 where you are in space and time. 15 The whole issue of ventilation is 16 extremely important to dose. And extremely 17 important to effects. And particularly in 18 this dose chapter, the word exercise is used. 19 But in most cases it doesn't have a modifier, 20 like moderate or very heavy. 21 And I'm thinking maybe even like a 22 little simple table. Like here's, you know,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 289 1 moderate exercise, this is this range of V dot 2 Es, and this corresponds to brisk walking, 3 whatever the case is. 4 And once you establish, here's the 5 definition of these terms, then you can keep 6 using words like moderate exercise or very 7 heavy, and not get bogged down in the details. 8 Let's see, I think that some of 9 the MOA is a real stretch. And I won't go 10 into detail, some of it's in my comments. 11 Maybe it's that I'm less familiar with some of 12 the literature. 13 But the effects on testicular and 14 sperm function, it seemed to me that, boy, 15 you're pulling at teeth to try and get an MOA 16 for an effect that is kind of susceptible. 17 There's another -- Page 5-65 18 discusses attenuation of responses. And Fred 19 had kind of brought this up earlier. 20 Attenuation needs to be defined. If you're 21 talking to like a policy maker, oh, 22 attenuation, oh, thank God, I don't need to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 290 1 worry about it now. 2 So there is an attenuation of 3 pulmonary function. And I think we all know 4 that there is not an attenuation of some of 5 the underlying inflammation and lung 6 remodeling that goes on. 7 And it could be that the 8 attenuation is actually the adverse effect, if 9 you will. Because if you're doing rapid 10 shallow breathing, it's going to keep a lot of 11 the ozone out of the deep part of the lung, 12 where some of those Type 1 cells are. 13 But once you no longer have that 14 rapid shallow breathing, once that attenuates, 15 then ozone just zips right on down. So all of 16 these are connected. And I think that notion 17 isn't brought out. 18 I guess the part that concerned me 19 most was on the issue of extrapolation. The20 animal to human extrapolation, I think tone21 wise, in this chapter, and in the other 22 chapters is two-thirds empty. And in my

### 202-234-4433 Neal R. Gross & Co., Inc. Page 291 1 opinion it's two-thirds full. Maybe the truth 2 is it's half and half. I don't know what the 3 truth really is. But all I know is this, that 4 the animal toxicology studies, they provide us 5 with what you say here, like biological 6 plausibility, things like that. 7 One thing that's not mentioned in 8 any of the chapters, the animal tox studies 9 provide us with a range of effects. If it 10 weren't for some of the animal studies, we 11 wouldn't know that Type 1 cells are going away 12 and being replaced by Type 2 cells that's 13 going to influence gas flow. 14 We wouldn't know what's really 15 happening in terms of pathology in the nasal 16 passages. Pathology in the respiratory 17 bronchials. We just wouldn't know. 18 And even in the text this stuff 19 is, you know, thrown out all lung remodeling. 20 I did a search, and this maybe is also true of 21 Chapter 6. I did a search. I couldn't find 22 the word Type 1 cell, whether I caught it with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 292 1 a capital 1 or number 1. 2 I mean, so this detail, this 3 richness, what did the animals tell us? Mary 4 Amdur wrote a whole paper once, "What did the 5 Animals Tell Us?" And they tell us a lot. 6 So my preference for this whole 7 later section here, where it's homology and 8 sensitivity -- homology and sensitivity, what? 9 That's boring. I mean, what this story is 10 about is animal to human extrapolation. 11 It has elements in there of 12 interspecies dosimetry, interspecies 13 sensitivity. And it has elements of 14 qualitative and quantitative. 15 And I would like to see a flat out 16 statement to say that there is, because of all 17 the similarities between animals and humans, 18 there's solid reason to believe that the 19 qualitative extrapolation will hold. 20 If you see the effect in several 21 animal species, it is likely that it could 22 occur in humans if exposure were sufficient.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 293 1 Now the word "if" is the quantitative 2 extrapolation that we really aren't 3 sophisticated enough to understand yet. 4 But if you put this in a context, 5 it will set the stage for a more direct 6 utilization of the human studies, the animal 7 studies. And even in the summary, there's one 8 paragraph on extrapolation. I mean, it just - 9 - so that's the whole thing about 10 underestimation of the value of animal 11 studies. 12 DR. SAMET: Okay. Steve, I wonder 13 if you have any comments on the genetic bit

14 here.

15 DR. KLEEBERGER: Later. 16 DR. SAMET: Later? Okay, okay. 17 And then, just to -- Jim. 18 DR. ULTMAN: I had one -- oh, I 19 still have my mic on. I have one follow up 20 comment after hearing Fred's comment. And 21 again, it goes back to this, what's causing 22 the effect of inhaled ozone, is it the ozone

### 202-234-4433 Neal R. Gross & Co., Inc. Page 294 1 molecules themselves that are reacting with 2 tissue or the reaction products. 3 And I think that one possibility 4 that would strengthen this discussion would be 5 to have some information on the various 6 components of what determines this, and how 7 important those components might be, and what 8 the uncertainties are, et cetera. 9 I'll give -- there is at least 10 one, probably two models, of reaction 11 diffusion through the ELF layer. There's at 12 least the one classical one, but there's 13 probably one or two more in the literature. 14 And I'm not suggesting that you 15 put the model equations in and explain the 16 whole thing. But maybe a graphical approach 17 could be used. Because there are various 18 factors. Fred mentioned the thickness of the 19 mucus as one factor in these models, as it 20 would be in physical reality.

21 Another factor would be the 22 reaction rate constants of the molecules

### 202-234-4433 Neal R. Gross & Co., Inc. Page 295 1 involved. And if you look at the literature, 2 there's a huge variation. And that's -- 3 actually, you mentioned that in the chapter. 4 There's a huge variation in what 5 is known about these reaction rate constants. 6 There's the concentration of the substrates. 7 There's the secretion rate of some of the 8 substrates, like uric acid, from the tissue 9 space itself. So there are various factors. 10 So I think if you could somehow 11 enrich the chapter, maybe with a paragraph 12 somewhere which explains -- and maybe a graph, 13 which shows what these various factors are, 14 how they effect the -- whether ozone is 15 causing the damage, or whether it's some 16 product. And what the sensitivity to these 17 various things might be. 18 I think it's not the -- it depends 19 on how you allocate your time. But it's not 20 beyond the current state of the literature to 21 do this. I'm not asking you to do a complete 22 remodeling and re-analysis. But I think it's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 296 1 a possible thing. And that might also help to 2 prioritize which products or which species are 3 more important than others. 4 DR. SAMET: Let's see, Fred, yes. 5 DR. MILLER: Judy's comment about 6 exercising, that trigger, to me you could 7 actually use Table 6-25 of the EPA Exposure 8 Handbook, where different exercise levels are 9 described in terms of pushing a wheelbarrow, 10 or moderate exercise, and so on. 11 So that you could, in fact, have 12 something like that in there. And then when 13 you refer to moderate or heavy exercise, a 14 person would already automatically be 15 conditioned to what kind of things you're 16 talking about. 17 DR. SAMET: Okay. I can see now, 18 CASAC meeting participation would be like 19 zero. And then you would move up from there. 20 (Laughter.) 21 Yes. I actually have two general 22 comments. One, doesn't this chapter need a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 297 1 different title? And I don't know what it is. 2 But you don't really describe what the chapter 3 is about right now. Because part of it is 4 about the terminance of response. So you need 5 a better title. 6 And then the only other general 7 comment. And I can't remember who made this 8 in their individual comments. But there's got 9 to be a lot of clean up in this document on 10 concentration exposure, dose. There's a lot 11 that's wrong. 12 And if you work on that, this cost 13 integration, bottom of page, Chapter 6, 5, 14 there's an absolute misrepresentation of a 15 potential inhaled dose, or whatever you want 16 to call it, versus exposure. 17 In this chapter it says that 18 exercises increases exposure. Well, if 19 exposure is C x T, exercising does not 20 increase exposure. 21 So I really think you need to set 22 out some -- you know, there's standards for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 298 1 this. I mean, you don't have to invent it. 2 And set up the terminology. And then just go 3 through and make sure it's been used 4 correctly. 5 And again, for example, in this, I 6 kept reading V sub E. Well, it's actually, I 7 think, when you mean ventilation, standard 8 terminology is V dot sub E, of course. Maybe 9 your problem is getting the dot over the V. 10 And when you figure out how to do it, tell 11 Fred how to do it. 12 But then the nomenclature, it just 13 all needs to be cleaned up. And I really 14 actually recommend that you go through. And 15 I think one of our commenters, maybe it's 16 Fred, maybe it's Judy, somebody gave you some 17 guidance on this. And it just sort of grates 18 when you see these things. Let me ask if 19 there are other comments on this. Yes, Jack. 20 DR. HARKEMA: So I reviewed this 21 the previous time. And I did go through a 22 thorough reading this time and then knowing

### 202-234-4433 Neal R. Gross & Co., Inc. Page 299 1 about the health effects. 2 Well, one thing that -- I'll put 3 my pathology hat on here -- it just does not 4 seem to me logical to present mode of action 5 before you have a discussion of health 6 effects. And I -- it was like you needed to 7 have a place to put mode of action so you 8 threw it in with dosimetry. 9 And it just -- I think that's kind 10 of the sum of the problem that we're having 11 here, is that you don't present the health 12 effects before concluding with the mode of 13 action. I would never write anything with a 14 mode of action without describing the health

15 effects.

16 DR. GRAHAM: Jon. 17 DR. BRAIN: It's really not the 18 full mode of action, isn't it? It's just the 19 initial biochemical reactions -- 20 DR. GRAHAM: No, no. 21 DR. BRAIN: I mean, it doesn't go 22 through all the --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 300 1 DR. SAMET: No, it's a little more 2 in depth though -- 3 DR. BRAIN: I mean, all the mode 4 of action can extend to how it effects 5 electrical stability to the heart and, you 6 know, airway muscle remodeling. I mean, 7 that's a big topic. 8 DR. SAMET: Judy.

9 DR. GRAHAM: Yes -- 10 DR. BRAIN: I mean you sort of 11 take it up to a certain point.

12 DR. GRAHAM: Yes. I would have 13 said the same thing, but I ran out of paper 14 for my comments. Joking aside, I believe the 15 same thing. And I decided not to just 16 reiterate that. 17 In my opinion, the proper MOA 18 that's in this chapter is how the ozone gets 19 into through the tissue, where it may lead to 20 extra pulmonary effects, or set up 21 inflammatory changes right then and there. 22 And I think I made that comment

### 202-234-4433 Neal R. Gross & Co., Inc. Page 301 1 before. And I think the decision was made to 2 keep the MOA here, with the explanation of, 3 well, you don't want to have the same thing 4 duplicated in the acute and the chronic 5 chapters.

6 And that's true. But a lot of the 7 MOA stuff, like for inflammation, is really

8 relevant to acute. So some of the MOA that's 9 here, it actually could be put in the acute or 10 the chronic chapter, along with the text. 11 Because when you actually get to 12 Chapter 6 and get to Chapter 7, there's an 13 attempt to repeat the MOA. There's some 14 cross-referencing, so I want to give credit to 15 that cross-referencing. But there still is, 16 there's a duplication that happens of 17 necessity, simply by virtue of the 18 organization. 19 DR. SAMET: Judy, would you 20 suggest -- I mean, a consideration would be to 21 have a separate chapter that pulls it out and

22 then can be referenced. I don't know. I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 302 1 suspect that there was some struggle about 2 what to do. And you ended up with one 3 solution to the problem. But would it be 4 better to have a separate chapter? 5 DR. GRAHAM: Well, I'd be happy to 6 leave that decision to EPA. I think that 7 there are three choices. One is the way you 8 have it now. The other is to have a separate 9 MOA chapter. It would look better. And the 10 other is to, you know, stop the MOA at the 11 molecular. And then when you go further, have 12 that further be part and parcel of the 13 discussion of the effect itself.

14 DR. SAMET: Fred. 15 DR. MILLER: Another solution, 16 Chapter 5 becomes 7, and 6 becomes 5, 7 17 becomes 6. And you discuss after the effects, 18 what's the likely dose and the mode of action.

19 So even Jack's concern would be 20 better if he was actually reading this from, 21 you know, Page 1 to, I don't know, 4000, 22 whatever it is. You know, you'd at least

### 202-234-4433 Neal R. Gross & Co., Inc. Page 303 1 maybe find that a little more palatable. 2 DR. HARKEMA: Actually, I thought 3 that's a good suggestion, is change the order 4 of the chapters. 5 DR. GRAHAM: But you need dose. I 6 mean, I think that conceptual needs to be 7 exposure, dose, response. And so, you know, 8 the Chapter 5 still needs to be in between the 9 exposure and the effects.

10 DR. SAMET: You can see we're 11 giving a crisp solution here. 12 (Laughter.) 13 DR. SAMET: Yes. John, do you have 14 any comments on that? 15 DR. VANDENBERG: Yes, this 16 actually is exactly the kind of discussion 17 we've had. It's hard to figure out where it 18 is without getting into a lot of redundancy. 19 We don't want to have a lot of redundancy. 20 So we put it together, and maybe 21 it's a bit of a force fit. So your comments 22 are, again, are noted. Perhaps it's the mode

### 202-234-4433 Neal R. Gross & Co., Inc. Page 304 1 of action part, in particular, that might go 2 later to explain why you're seeing the

3 effects. 4 And that might be a natural split 5 there. Because I think our tendency has been 6 very much dose precedes effect, or response, 7 you know. And so maybe that's one of the ways 8 we could look at it. 9 DR. SAMET: But it seems to me 10 that if -- you know, just looking at it, if 11 you took it down to sort of this level of 12 tissue cellular dose, and you stop there, then 13 the modes of action are not divisible into 14 acute or chronic. I mean, inflammation being 15 a good example. 16 So that, you know, maybe, at least 17 in my mind, it would be preferable to have the 18 mode of action come before as sort of a 19 mechanistic set up for Chapters 6 and 7. 20 And then maybe you could cut back 21 some. But I, you know, there's multiple ways 22 to go. And I suspect we're not going to come

### 202-234-4433 Neal R. Gross & Co., Inc. Page 305 1 up with strong preference around the table. 2 But if you stick with what it is, 3 I think this chapter does need to somehow be 4 brought together or better explained. And 5 maybe if you pulled out the mode of action 6 material and you have a shorter chapter. I 7 think then -- it's also the question of where 8 some of the stuff on genetics goes. And, you 9 know, we'll come back to that I guess when we 10 get to Chapter 8. 11 So maybe we could hold the 12 discussion until we move a little further 13 along in the document. It looks like there 14 might be some better ways to do it than what 15 you have. 16 DR. BRAIN: I would just point out 17 that in the Executive Summary, again, the 18 sections are human exposure, dosimetry and 19 modes of action. And then ozone health 20 effects. And for me, at least in the 21 Executive, it works. I mean, that seems to be 22 kind of a logical flow.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 306 1 DR. SAMET: Okay. So why don't we 2 leave this question and go to Michelle and the 3 team on Chapters 6 and 7. This shouldn't take 4 long. 5 DR. BELL: I'll just need two 6 seconds, all right. So first of all, when I 7 looked through the preliminary comments that 8 people submitted, I was very encouraged that 9 people are largely on the same page. So we 10 have a lot of consistency. And we'll see that 11 when other people respond, I hope. 12 A lot of my comments, that many 13 other people mentioned as well, correspond to 14 both Chapters 6 and 7. So I'll start with

15 those. 16 And the first is that I, and many 17 other people, found this version to be 18 substantially improved over the previous 19 version. Personally, I was extremely 20 impressed. Because we gave you a lot of work 21 to do. And it's very obvious that a lot of

22 work was done.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 307 1 Some of the things that are much, 2 much better are the organization. There's a 3 big expansion of these chapters. There's a 4 lot more clarification, more information on 5 the studies. I thought all of that worked 6 very, very well, especially for Chapter 6, but 7 both of the chapters. 8 One issue that got better, but is 9 still there, is this issue that relates to a 10 lot of the other chapters as well, of the kind 11 of the new studies versus the old studies. 12 And because it's obvious different 13 sections of this were written by different 14 people, how that's treated tends to be a 15 little different in different parts of the 16 ISA, which I'm sure we want to clean up. 17 But very often the words like new 18 and recent refer to things within the past few 19 years, I think. Or very often they refer to 20 studies that came out since the last ISA. 21 I think part of what happened here 22 is that there is an effort to keep this more

### 202-234-4433 Neal R. Gross & Co., Inc. Page 308 1 brief and to not keep rehashing the old

2 documents. 3 And several times in these 4 chapters they refer back to previous ISAs, or 5 the previous criteria documents. I personally 6 did not think that worked. It's not going to 7 be a brief document. 8 I mean, it's already two phone 9 books. If it was three phone books it 10 wouldn't be that much more unmanageable than 11 it is now. 12 So I appreciate the effort to be 13 brief. But I think that this, you know, 14 what's useful for regulatory purposes are not, 15 what's new science? But, what's the state of 16 the scientific evidence? 17 And it's useful to talk about how 18 that's changed since the last time. But to me 19 in both these chapters it just seemed like a 20 very artificial division. So I think you have 21 two options. 22 One is to expand this even

### 202-234-4433 Neal R. Gross & Co., Inc. Page 309 1 further. And this is my personal preference, 2 to expand this even further and actually pull 3 in more of the previous studies that are very, 4 very relevant. 5 I don't mean every single study 6 that ever existed. But, you know, those kind 7 of mammoth tables and things like that, that 8 we always talk about begin kind of unwieldy, 9 they're incredibly useful. They're not just 10 useful for this process. 11 This is a useful document of the 12 state of the science. So it's already not 13 brief. So my preference would be to just blow 14 it up and make it even bigger. Because it 15 would better state the science. That doesn't

16 work for me. 17 Your second choice is to just be 18 very systematic about it. Like if you're 19 going to define at the beginning, and perhaps 20 a few reminders throughout the document, the 21 word new means studies since this date. Or 22 something like that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 310 1 You could do that, not go back and 2 forth between new and recent. But pick your 3 favorite. And you could define it that way. 4 If you just really can't stand option one, 5 which would be a lot more work. 6 But I do think you want to do 7 something about this issue, because it's a 8 little bit confusing. A point that relates to 9 both these chapters, and several reviewers 10 commented on this, relates to other chapters 11 as well, is, you know, there's several new 12 studies to pull in. 13 I and many others are going to 14 give you some specific examples. But given 15 that there's been a lot I think it's worth 16 considering whether or not you actually want 17 to do a new literature review. 18 And part of your decision might be 19 whether or not we actually go to a third 20 round. And do a third round of, a third draft

21 of the ISA. Or whether or not we have Jon's 22 optimistic view point.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 311 1 But, you know, at some point you 2 have to cut it off. I mean, you can't just 3 keep going on and on and on forever. But 4 we've gone on for a while. And I feel like 5 it's something that should be considered. 6 So my recommendation is not to do 7 that, but to consider that in light of 8 whatever time line develops. And EPA can make 9 a decision. 10 There were a few parts for the 11 human clinical studies where I think some more 12 information could be used. And Judy might 13 want to talk about this more, because her 14 comments talked about this a bit. 15 What are kind of the real world 16 implications of some of the settings of the 17 human clinical studies? And what are the true 18 effects at kind of the lowest exposure levels 19 used in the human clinical studies? So that 20 could use some more expansion out. 21 With Chapter 7 in particular, one 22 issue, well everything else I'm going to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 312 1 mention for Chapter 7 is stuff that has been 2 improved a lot. So I want to give UPA a lot 3 of credit for that. But I think we still have 4 a little ways to go. 5 And one is this issue of what does 6 it mean for long term exposure? I really 7 harped on this last time. And it's gotten a

8 lot better. 9 There's definitions at the very 10 start of the chapter. This is what we mean by 11 long term exposure. And so that works much, 12 much better, until you get to tables and 13 discussion of exposures of a single day. 14 I still don't understand why 15 they're in there. And it happened a lot. 16 It's not like one or two things that slipped 17 in. It's clearly a conscious decision on the 18 author's part to include these short term 19 exposures in the long term chapter. 20 What I think is happening, and I'm 21 interested to hear from UPA what it happening. 22 What I think is happening is that they're

### 202-234-4433 Neal R. Gross & Co., Inc. Page 313 1 trying to group all the birth outcome studies 2 together. Because that's where it tends to 3 show up. 4 So again, I think you have a 5 couple of options. One is to start off at 6 that chapter and somewhere explain, like 7 explicitly tell the reader, we're going to 8 have some short term studies in here. Because 9 we really want to group birth outcomes. 10 This is not my first choice. I 11 think you're going to have to provide a 12 rationale for that. I mean, the whole 13 division between Chapter 6 and 7 is that we're 14 splitting exposures for things like 15 respiratory mortality. We split them. 16 So why you don't want to do it for 17 birth outcomes, but we do it for everything 18 else is confusing. I mean, this is a very 19 fixable thing. 20 So my preference would be to move 21 the short term exposures to the short term 22 exposure section. So this is stuff in Chapter

### 202-234-4433 Neal R. Gross & Co., Inc. Page 314 1 7 that deals with a few days. There's tons in 2 here that's like a single day exposure. Or, 3 if you can provide a really good rationale, 4 move it. 5 So I'm interested in other 6 people's thoughts. But personally it makes a 7 lot of sense to me that, you know, it could be 8 a different biological mechanism happening 9 when you have a one day exposure for infant 10 mortality versus the gestation long exposure 11 for low birth weight. I have no problem 12 splitting those up myself. 13 And my final comment, which 14 relates to Chapter 7. One thing that I asked 15 for last time, and I think other people asked 16 for as well, is to change the standardization 17 of units, so that you don't have one study 18 giving a risk estimate for 5 ppb and another 19 study giving a risk estimate for 15 ppb, and 20 you're looking at those numbers together. 21 So that has largely been addressed 22 where you have this kind of standardized unit.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 315 1 They've converted on the different metrics. 2 So you have an increment for the 24 hour 3 that's kind of comparable to an increment for 4 the one hour max, and so on. 5 There's just two issues with that 6 that still need to be fixed. And again, these 7 are fixable things. One is, the description 8 of that is sometimes buried in footnotes. I 9 would pull it out. 10 I don't think this is just an 11 editorial issue. I think that this is going 12 to be confusing for people if we don't. So I 13 would suggest pulling that out. 14 There's several places where it's 15 very nice. In the tables it will say, you 16 know, standardized unit, or something like 17 that. And I think that that language, using 18 standardized unit, is really nice. 19 That was not my suggestion. I 20 don't know who came up with it. But I thought 21 that worked very well. But here's something

22 that does not work at all.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 316 1 A standard increment of ozone 2 increases respiratory mortality by five 3 percent. There's no such thing as a 4 standardized increment of ozone. I really 5 don't think we want to define it as 10 ppb, 6 and then use that throughout the document. 7 So although I think it was an 8 absolutely necessary improvement to move 9 towards comparable units, I don't like to see 10 the numerical values replaced with the word 11 standardized. 12 So instead just say 10 ppb. I 13 think that's going to be very confusing to 14 people. So that's something just where you 15 have the word standardized increment, 16 replacing a number in a sentence, you can just 17 flip it back to the number. 18 And the ratio that's used to 19 convert between the different temporal 20 metrics, the 24 hour, the daily eight hour 21 max, and the one hour max, are not the same 22 throughout Chapter 7.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 317 1 I don't know if this is because 2 it's different authors. But you can't use 3 different ratios to convert those in the whole 4 ISA. And you really don't want to do it in 5 the same chapter. 6 So in my written comments I'll 7 give more details about some places where I 8 caught this. But you also just want to go 9 through and make sure you have the same 10 conversion amongst temporal metrics throughout 11 the whole document. And that's all of my 12 major points. 13 DR. SAMET: Okay. Thanks 14 Michelle. Mike. 15 DR. FOSTER: So I really echo 16 everything Michelle said. And she's right. 17 When we looked at each others comments, I 18 think Jack has a much greater laundry list, 19 and I don't want to take up too much of his 20 time.

21 But I felt that overall I focused 22 on the requests that were made. I did review

### 202-234-4433 Neal R. Gross & Co., Inc. Page 318 1 Chapter 6 in the initial version. And I was 2 in charge of sending through to the group and 3 editing out and sending the questions on to 4 John's group. 5 And I thought they were answered 6 quite well. I think you addressed this, at 7 least in Chapter 6, I think you addressed 8 quite well the question over adaptation and 9 attenuation, those kind of issues. 10 You didn't confuse the 11 terminology, I didn't believe. I think you 12 dropped out some of the information. The 13 things that we did ask you to do increased the

14 volume of the text. 15 It went up by my calculation about 16 30 percent if you just looked at increased 17 figures and page numbers of the text, and 31 18 pages of references. 19 So I think the rest of this panel 20 got off easy by not having to review this 21 chapter. I mean it was, it was a good eight 22 hour flight to Europe and coming back that I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 319 1 got through it. So I mean, it was a lot of

2 work. 3 But I think one of the things I 4 just noticed, because it's kind of something 5 that I kind of think about more to my own 6 research, was the fact that there was the 7 ability to draw in, say a respiratory effect 8 in a susceptible population, with a mortality 9 effect in that same ethnic population. 10 And I noticed that they were 11 disparate. They were in the beginning of the 12 chapter and at the end of the chapter. And I 13 made comment in my comments about that. 14 Something's jumping out at you like that, 15 there might be something more to it than just 16 a random thing. That there's parallel effects 17 in this ethnic population. 18 But I thought overall, once again, 19 I reiterate everything that Michelle said. I 20 thought, I did have trouble with, I didn't put 21 it in my comments. But when I read her 22 comments about distinguishing short and long

### 202-234-4433 Neal R. Gross & Co., Inc. Page 320 1 term, I guess we need some definition of what 2 is meant by that. 3 I did add in some new references 4 that I thought might be helpful. You don't 5 necessarily have to use those. They are, with 6 some bias, pretty much related to my own 7 laboratory or people that I collaborate with. 8 But I think they're appropriate. And so I've 9 indicated those. And outside of that, that's 10 about it, Jon. Thank you. 11 DR. SAMET: Okay. Sverre. 12 DR. VEDAL: Yes. While I'm 13 thinking about it I'll just react to the issue 14 about new information versus old information. 15 I fully agree with the issue of having that 16 standardized. I think that's helpful. 17 But I do find it useful to 18 distinguish the two, just to focus my own 19 thinking about where the field has gone since 20 the last review, rather than putting the 21 entire world of research together here in this

22 one document.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 321 1 And I think that the way that this 2 has been moving is to have a more concise 3 document as time goes on. And I think it 4 works in that way. But again, I think the 5 point about standardizing, you know, what is 6 new and what is old is important. 7 Take a little bit of a different 8 tack too with my responses. I'm going to 9 touch a little first on sort of the lung 10 function stuff. 11 I'll try to be brief about that. 12 I know there's been some de-emphasis on this, 13 even though it still plays a very central role 14 when we think about concentrations and levels

15 for the standard. 16 But just a few quick points. This 17 issue of the acute lung function response in 18 some sense has been a very difficult pill for 19 many people to swallow. 20 That it's just, you know, this 21 neural mechanism that's going on. And in your 22 description of this effect you always bring in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 322 1 this broncho constrictive effect. 2 And a lot of people, you know, 3 there's evidence for it there. But, you know, 4 it's really not playing a big part, if any 5 part, in this acute response. 6 And, you know, you can't do 7 anything about it with inhale bronchodilators. 8 You can't do anything about it with 9 corticosteroid administration. Maybe there's 10 something going on suddenly in the small 11 airways. But really who cares? 12 In this setting, it's this acute 13 little neural reaction that's going on. And 14 to try to embellish it and make it into 15 something more than that, I think is just a 16 misread of the, you know, of the data. 17 It's not inappropriate to talk 18 about those other things in other settings. 19 But in terms of this acute response, I think 20 it's just misleading. 21 Milan Hazucha brought up this 22 issue of the filtered air with exercise

### 202-234-4433 Neal R. Gross & Co., Inc. Page 323 1 versus, you know, how you characterize the 2 response. 3 And, you know, the one weird thing 4 about looking at comparing to sort of post 5 exercise responses is that, basically you end 6 up saying, well the effect of ozone is not to, 7 is to lessen the improvement that we have with 8 exercise, which introduces this notion of, 9 well how adverse is that really? 10 So it's, I don't know the answer 11 to it. I think maybe both things sort of need 12 to be presented in some way to sort of give it 13 the complete picture. 14 This issue of concentration time 15 and mini ventilation, you know, has been sort 16 of a standard thing with ozone in particular. 17 It's kind of a poster child for that notion. 18 And it's presented here as well. 19 But it's followed right away by this 20 discussion of square wave versus triangular 21 wave exposure, which in some sense undermines, 22 to my mind, undermines that initial concept to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 324 1 some extent. 2 And it's a little bit confusing, I 3 think, when they're presented in that way. 4 Because they both can't be completely true, 5 right. 6 And then finally, you know, I 7 think there's been some discussion today about 8 this, is that I think there still is something 9 missing about trying to interpret this acute 10 lung function response in the entire spectrum 11 of, what does it all mean? 12 You know, there's something there 13 trying to bring in the panel study results and 14 such. But, you know, we have a situation here 15 where, as has been pointed out today, you have 16 exercise for six, well intermittent exercise 17 at a fairly, you know, moderate, brisk pace 18 for six some hours. 19 And then we're trying to say 20 something about, you know, effects of this 21 response on people where it really matters, 22 like severe asthmatics, or people with COPD,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 325 1 who probably aren't going to be doing this 2 kind of stuff anyway. 3 So something about trying to put 4 it together where it really does what, you 5 know, what the significance of this thing, 6 what you think the significance of this thing 7 is. 8 And, you know, you can try to do 9 that with bringing in some of the clinical, 10 not the experimental studies, but the panel 11 studies and such. And there's some allusion 12 to that I think. 13 The sensitive sub-population 14 issue, I'll just make a small point here. To 15 me it's kind of a little bit all over the map. 16 And we'll be discussing some of it in the 17 Chapter 8 issue. 18 But I think whenever this is 19 described, I think you should never, never say 20 that sensitive sub-populations are blah, blah, 21 blah. The evidence doesn't support that. I 22 think it has to be characterized as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 326 1 potentially sensitive sub-populations at this 2 point. 3 I don't think I can point to 4 anything that would make me confident in the 5 statement that's saying this, as I said. 6 Including young children, including the 7 elderly, our favorite sensitive sub-groups. 8 There's, in this, well most of 9 Chapter 6 and 7, I think one of my hobby 10 horses is selective. You know, selection 11 finding, selection of parts of studies that 12 tend to support a point. 13 I think there's much, much less of 14 that in this version of the ISA. And I really 15 like that. I think it's quite even handed as 16 a rule. And I found that refreshing. 17 With respect to sort of newer 18 findings again. The one thing where somewhat 19 surprisingly, I think newer data has in some

20 sense weakened the case rather than 21 strengthened the case, has been the issue of 22 respiratory symptoms and medication use in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 327 1 asthmatics. 2 And I'm particularly referring to 3 the multi-city studies that have looked at 4 those endpoints. And here we have an issue 5 where we've now got multi-city studies, which, 6 you know, there's a precedence for putting 7 more weight on multi-city studies. And

8 there's a reason for that. 9 And here we have multi-city 10 studies on those endpoints. And yet the 11 results are contradictory, and sometimes flat 12 out negative. 13 And the conclusions, with respect14 to those endpoints are, everything's hunky15 dory. Things haven't changed. But I think 16 they actually have changed. 17 I'm not going to, with respect to 18 non-respiratory endpoints, and I'll try to be 19 very brief. And I think it's important, and 20 you've done this before in bringing up the 21 classic Henry Gong study from the late '90s 22 about talking about sort of effects on

### 202-234-4433 Neal R. Gross & Co., Inc. Page 328 1 saturation and such. 2 Well they also demonstrated an 3 increased heart rate in that study, right. 4 And it's like the first one was a human 5 clinical study where there's a cardiovascular 6 endpoint. 7 So it's important to not just, I 8 don't know why it's not there. But it does 9 actually help to sort of shore up experimental 10 evidence in that end point. 11 There's a statement that with 12 respect to cardiovascular effects, there's no 13 apparent biological mechanism to explain short 14 term ozone effects on cardiovascular 15 mortality. 16 Really? Because, you know, you 17 can by analogy use some of the same mechanisms 18 that are used for explaining the PM effect. 19 And I think of two of them in particular. 20 Pulmonary inflammation. Okay, you 21 can make this case about spill over and 22 pulmonary inflammation, even thought the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 329 1 pulmonary inflammation is arguably 2 qualitatively different than that that occurs 3 with PM.

4 And then there's the neural 5 mechanism, which is front and center here with 6 ozone, about affecting airways, receptors, 7 autonomic modulation. 8 And once you have that, systemic 9 inflammation, oxidated stress, you're off and 10 running. So, you know, I think you can make 11 some fairly reasonable arguments about 12 plausible mechanisms. 13 Long term exposure effect. Try to 14 be very brief. There are basically two very 15 important new studies in the area of long term

16 effects. 17 One is the Children's Health Study 18 findings on new onset asthma. And the second 19 one is the American Cancer Society study on 20 respiratory mortality. 21 The new onset asthma, I've never 22 been a fan of the findings, the early findings

### 202-234-4433 Neal R. Gross & Co., Inc. Page 330 1 on new onset asthma, where they show that 2 children who had like two or three more 3 activities outside had more risk of new onset

4 asthma. 5 There was a very small study. Now 6 the tack that these investigators have taken 7 is a gene environment interaction tack. What 8 I'm looking for is the main effect of ozone 9 exposure on this endpoint. 10 And to me the, and it's not their 11 fault. Their interest is in genes primarily. 12 They've taken primarily a gene main effect 13 approach. And then sort of looked to see 14 whether ozone modified that. 15 And, you know, the bottom line was 16 that the effect was in low ozone communities, 17 where you had this differential between the 18 two effects of the polymorphism. 19 I still am not, I think at the end 20 of the day you kind of need to look at that 21 study again and just see whether it, you know, 22 it's within a central role. And I agree it

### 202-234-4433 Neal R. Gross & Co., Inc. Page 331 1 should be. Children's Health study is a very 2 important study. 3 But in terms of the actual main 4 effect question, does ozone cause new onset 5 asthma? I think perhaps you should reevaluate

6 that. 7 The American Cancer Society study, 8 you know, is a very important study. And I 9 think what you did with interpretation of that 10 is good. 11 Final point, and it relates to the 12 issue of long term/short term exposure. And 13 I fully agree with the things that Michelle 14 said about that earlier. 15 There are some endpoints that 16 could be, including, you know, birth outcomes. 17 But there are some other end points. ED 18 visits, hospitalizations that are, that can 19 and have been analyzed both in the long term 20 and the short term perspective. 21 Here it is in the long term 22 exposure chapter. But essentially here it's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 332 1 someone decides to define exposure based on a 2 long term averaging metric. And then make 3 some conclusions about these very, essentially 4 short term endpoints. 5 And it's basically determined, 6 pre-determined by how you define exposure. If 7 you're going to do that, you either have to 8 try to control for short term exposure 9 effects, so that you can try to tease out what 10 is, in fact, a long term exposure effect. Or 11 something else that allows you to sort of 12 distinguish those time scales. 13 Otherwise it's, you know, you're 14 basically following the path of where the 15 investigator wants to lead you about the 16 importance of long term exposure. And it may 17 have nothing to do with long term exposure. 18 Yes, that's it. 19 DR. SAMET: Okay. Jack. 20 DR. HARKEMA: So I had, this is 21 kind of the first time I reviewed this 22 chapter. So I don't, wasn't familiar with all

### 202-234-4433 Neal R. Gross & Co., Inc. Page 333 1 the suggestions from the first time. 2 But in general I thought it was 3 very well written. And I agree with 4 everything that has been said, especially with 5 -- And Michelle was talking about putting it 6 in the context of previous studies and newer 7 studies. 8 I still would like to see that. 9 And I think the epidemiology sections did that 10 fairly well. I think the toxicology sections 11 were a lot of detail on previous things that 12 were in the earlier documents. And I would 13 cut that back. I would rather have it focus 14 more. I wouldn't go to three volumes. I

15 would -- 16 DR. BELL: I wouldn't want to go

17 to three volumes. 18 DR. HARKEMA: But anyway, I think 19 it would flow a lot better there. And a lot 20 of things have already been said. There are, 21 I don't know I found three or four in there, 22 in press type of things.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 334 1 You don't want, maybe that was 2 just for you to clean up when you're doing 3 this again. But there's two or three 4 references that are in press. And that should

5 be corrected. 6 I thought there was a lot under 7 the controlled human exposures. There was 8 quite a bit of emphasis on why you're doing, 9 having an air control. And I think that's 10 good. 11 But then I think because of what 12 we heard this morning, and I put in there. I 13 think it would be wise to talk a little bit 14 about those studies. 15 Or if they hadn't done it, looked 16 at, you know, the exposure history before the 17 subjects come in, and that type of thing, just 18 in terms of background. 19 I especially liked the newer data 20 that came out of the cardiovascular. Because, 21 again that was the newer stuff coming in here. 22 But I was a little troubled at the end, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 335 1 this goes to sort of a general comment about 2 causality in these different hierarchies here. 3 I can't figure out how you can get 4 cardiovascular effects being a suggestive or 5 a causal relationship. And mortality, where 6 you emphasize in the short term, we're not 7 talking about long term, but the short term, 8 cardiopulmonary related mortality. And that 9 is a likely to be causal relationship. 10 And so I think there needs to be 11 some more in-depth rationale of why you're not 12 giving likely to be cause relationship for 13 the cardiovascular if you're going to stick 14 with the mortality. Or talk about the 15 mortality being more respiratory or something. 16 But there was a disconnect there 17 for me. In fact, I'm worried about in the 18 Executive Summary, or the Chapter 1 now, the 19 preamble in Chapter 2, that those 20 cardiovascular things are going to be lost. 21 And I know you only have a figure 22 there now, a triangular, a pyramid for the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 336 1 respiratory effects. And there's nothing 2 there for cardiovascular, which predominantly 3 was the newer stuff that is coming out. 4 That's not emphasized. 5 Now maybe that's the conclusions 6 that you were trying to make here. But I 7 still think there's a lot of this 8 cardiovascular that we don't want to, you9 know, forget about not emphasizing in the up10 front. 11 The other thing is about exposure 12 again. And reading through the exposure like 13 Sverre was talking about the square wave or 14 the triangular exposure. There was a lot of 15 discussion about exposure. 16 And then you came to the next 17 section. And the next section, I forgot 18 exactly what it was. But there was really no 19 mention of what type of exposure it was that 20 the animals were, or the humans were getting. 21 And this whole discussion about, 22 you know, the importance of square wave, or

### 202-234-4433 Neal R. Gross & Co., Inc. Page 337 1 triangular, that emphasis. And then all of a 2 sudden it was just a regular old exposure. 3 So if, you know, then you kind of 4 lost well, what's the importance of square 5 wave or triangular. And there is overall I 6 think it captured almost everything that I 7 would like to have in those sections. 8 But there was no, you know, the 9 importance of it, you know. So what is a 10 square, why is it important to have square 11 wave or a triangular wave? And that can be 12 simply, you know, very simply addressed there. 13 There are some sections, I think 14 the section on pre-existing diseases, that 15 there was sort of a lack of explanation of 16 what type of exposures were actually

17 conducted. So that needs to be looked at as

18 well. 19 I think I want to also mention 20 that not only are there some references where 21 you had one day exposures, or something like 22 that in the long term. But you also had some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 338 1 areas, and I'm not going to go through that, 2 where there were some longer exposures that 3 were captured in the acute short term 4 exposures as well. 5 I would like to see a little bit 6 of more integration between the epidemiology 7 and the toxicology. I don't know if that's 8 possible. But you can -- I think that would 9 be a good thing to do. 10 And I would like to see more of 11 each topic having a summary, and not just 12 listing of studies and then going on to the 13 next one. And you kind of fall into that 14 patterns sometimes. The overall summaries I 15 thought were very good and nicely written. 16 And then finally, I just bring up 17 one study in the cardiovascular that I think 18 should be included here. Because it has 19 reference to one of the toxicology studies. 20 There was a study out of Emory 21 where they looked at infants that were on 22 monitors. And they demonstrated that exposure

### 202-234-4433 Neal R. Gross & Co., Inc. Page 339 1 they could have, there was a correlation 2 between ozone concentrations and bradycardia. 3 And that goes a lot with 4 cardiovascular science that Penn Watkinson 5 showed several years ago. And I thought that 6 would be a really nice, you know, correlation 7 and that, as a recent study. 8 So I wouldn't minimize. There was 9 kind of a minimization of that effect of this 10 decrease in heart rate in the animal studies. 11 Well these are rats, and so on. 12 But it's probably most likely 13 that's due to a trigeminal cardiac reflex. 14 And that's the most powerful autonomic reflex 15 that we know of in mammals. 16 And so that study, along with that 17 recent study out of Emory is a nice example to 18 put in. Other than that, I don't think I have 19 to go on with others. 20 DR. SAMET: Okay, good. Thank you 21 for advocating for the rats. Let's see. 22 Okay, John Bailar can't be with us, but I just

### 202-234-4433 Neal R. Gross & Co., Inc. Page 340 1 wanted to -- He had sent an email earlier, 2 raising one point. 3 And I think I want to sort of go 4 back and refocus you a little bit on some of 5 the bottom-line conclusions as well. And 6 whether you are in agreement, more or less, 7 with the level of strength of evidence that 8 the chapter reaches around that calls some 9 conclusions. 10 John's brought up a point. And 11 I'll just read a little bit. Finding that the 12 strength of evidence for an effect on a broad 13 category of outcomes is lower than the 14 strength of evidence for some components. 15 So one example, let's see. One 16 cannot have, for example, an increase of 17 cancer of the lung without an increase in 18 total cancer, whether it's direct evidence of 19 that or not, except in the unlikely event that 20 there are compensating decreases elsewhere. 21 And I think as we go back and look 22 at the conclusions we should look at some of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 341 1 the endpoints used. I think sometimes this is 2 not really, the way things are grouped is not 3 necessarily coming from agency decisions, but 4 the way epidemiologists have grouped. 5 And very often I think we use 6 these rather non specific, it's not a 7 confession, groupings. Because numbers are 8 increased and you end up with something like 9 total cancer, which doesn't really have 10 specificity when you get to something like 11 ozone, unless there's some broad overarching 12 mechanism that one would think about. 13 So we should just, I think, look 14 at John's comments. But I do want to go back 15 through the group. And you've talked a lot 16 about the methods and the presentation. But 17 what about the bottom lines here?

18 And then I have one other comment 19 I'll make after that. I just want to make 20 about this new/old/recent bit. So Michelle, 21 Sverre, anybody? 22 DR. VEDAL: Well I think the one

### 202-234-4433 Neal R. Gross & Co., Inc. Page 342 1 that we should address is the one Jack brought 2 up, which is this apparent inconsistency where 3 in the short term there's a suggestion on 4 effect for, I guess, cardiovascular disease. 5 And then a likely effect for total mortality. 6 Now, so I mean, in some sense 7 those are logically inconsistent. And, you 8 know, what the options are to maybe downgrade 9 one, or upgrade the other. 10 And, you know, I think I'm on the 11 same page as Jack in this. And it would be to 12 upgrade the cardiovascular evidence, or the 13 classification. 14 DR. SAMET: Because you view the 15 evidence as sufficiently strong? 16 DR. VEDAL: Yes. Yes, as a whole. 17 I wouldn't do it based on just the epi. But 18 I think given the new tox data, I would, yes. 19 DR. SAMET: Okay. Michelle, do 20 you have any comments? 21 DR. BELL: Yes. I think I agree. 22 I would probably upgrade it as well. I mean,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 343 1 it's difficult, you know, if you have 2 something like likely causal. And I might 3 call it like, highly likely. But we don't

4 have that. And we shouldn't. But I would not 5 be opposed to upgrading it. 6 DR. SAMET: Anyone else? Mike, do 7 you have any comments on the overall, the 8 causal classifications designations? Are you 9 comfortable with what they are now? 10 DR. FOSTER: Jon, you know, for 11 the respiratory mortality it was likely. And 12 it wasn't nearly as strong as we've given for 13 the respiratory effects. 14 And Michelle and I both found some 15 disagreement. And we thought that the 16 evidence for mortality and respiratory 17 mortality to be very, very strong, with all 18 the recent data that John's group had added. 19 So it seems to me that when 20 comments are developed, that this is something 21 that at least if the panel feels that there 22 should be a change in the classification of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 344 1 any of these, whether up or down, that there 2 be a clear comment and expectation. 3 Probably for the point of view of 4 peer review there ought to be, yes we agree 5 with what is there or not there. Or at least, 6 it's not that we agree with what is there or 7 not there, but the agency has made the case 8 for what they have determined. I think that's 9 really the critical. 10 DR. BELL: Jon, can I ask, since 11 I'm going to be the one writing up our 12 section. Is it our role to advise EPA to 13 reconsider their classification? Or is it our 14 role to tell them what we think it should be? 15 DR. SAMET: I would suggest it's 16 our role to advise them. We are back to the 17 Clean Air Scientific Advisory Committee, to 18 advise them. And say, here's why you might 19 consider doing this. 20 DR. BELL: Right. But not to 21 advise them what it should be? Just advise 22 them to reconsider?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 345 1 DR. SAMET: Well, I think -- 2 DR. BELL: Or can we advise them -

3 - 4 DR. SAMET: No, I -- 5 DR. BELL: No, I'm serious, like -

6 - 7 DR. SAMET: I don't think -- 8 DR. BELL: Are we going to suggest 9 a specific classification? 10 DR. SAMET: I think you might 11 suggest on the strength -- 12 DR. BELL: Okay. 13 DR. SAMET: -- of evidence, where 14 it's an upgrading or a downgrading, one way or 15 the other. Yes, Judy. 16 DR. GRAHAM: Yes, a couple. 17 There's one area here where, you know, we

18 can't reach a consensus. One area that also 19 impacts the summary. And that is lung 20 inflammation is mentioned. Increased pmms are 21 mentioned. 22 But it's given short shrift. So

### 202-234-4433 Neal R. Gross & Co., Inc. Page 346 1 example, I can go here in the text and find 2 out what the percent change in FEV1s was. I 3 cannot find what the percent change in pmms 4 was in the same exact study. 5 And in my view at least, I'm more 6 worried about lung inflammation than I am 7 about a fleeting change in pulmonary function. 8 So I think that whole issue needs to be beefed 9 up, and more attention given to the severity 10 of some of these endpoints. So it's more 11 possible for policymakers to say this is 12 adverse, this is not adverse. 13 I guess one of my concerns is, we 14 obviously don't have consensus on two issues. 15 And that is the old versus the new in the

16 tables. 17 I'd like to be a proponent to 18 eliminating the distinction between the old 19 and the new. The reason I say that is, this 20 is not just any document. This is the 21 foundation of the NAAQS. 22 The NAAQS is to protect people

### 202-234-4433 Neal R. Gross & Co., Inc. Page 347 1 against adverse effects, not just effects that 2 were discovered in the last five years, but

3 effects. 4 And even if you take, like take 5 the richness of human clinical. If I went 6 through and erased all the old stuff, we would 7 have some excellent new studies. But we 8 wouldn't have the weight of evidence. 9 If I took away all the old animal 10 tox we wouldn't have the weight of the 11 evidence. We wouldn't even really understand

12 some of the old effects. 13 So I don't see that there's any 14 distinction, there should be any distinction 15 between them. I think the fact that there is 16 a distinction as to impacts. 17 One is that it's an excess 18 duplication. Because some of them you say 19 here's the old, here's the new. And then here 20 comes some more old to buttress what I just 21 said. 22 In some cases it's actually

### 202-234-4433 Neal R. Gross & Co., Inc. Page 348 1 misleading to talk about the new if it's not 2 in contrast with the old. So it gets very

3 confounded. 4 If it were just the story of 5 here's what ozone does, and not having all the 6 old information equally presented is not so

7 bad. 8 It would include extending the

9 tables. But the text doesn't need to be 10 extended in a corresponding way. In fact, the 11 text would decrease by removing some of the 12 duplication. 13 So if you see, you know, here's a 14 whole class of the facts. Have a paragraph 15 describing the class of the facts. Right now 16 the text is buried. Well parentheses, how 17 many hours of the day was the exposure? 18 All the details are buried in the 19 text. If they were in tables some key studies 20 could be selected. In some cases the key 21 studies would be the old ones. 22 In some cases an old study of .12

### 202-234-4433 Neal R. Gross & Co., Inc. Page 349 1 ppm in an animal, which is given short shrift. 2 And there was a whole paragraph devoted to a 3 1 ppm study. So I think that we need to keep 4 our eye on the science, and not our eye on the

5 date. 6 The allusion I offered in my 7 comments was, I'll use the word silly to make 8 the point. In three cycles from now, do we 9 want to just have an ISA of one page saying 10 nothing's new because there is no new money in 11 research? Go read five old documents. 12 In some cases the reference, it 13 says, go read the 1986 tables, for God sakes. 14 So, I mean, I think that we are worshiping a 15 false God of page length. We need to worship

16 at relevance. 17 So that's my argument for that. 18 And as a fine point, these are questions for

19 Jon. It bothers me about the Adams 1998 data 20 being unpublished and not being in the 21 document, given that EPA has no access to it. 22 I think that some of the data he

### 202-234-4433 Neal R. Gross & Co., Inc. Page 350 1 published openly. But it's still, unpublished 2 data is kind of nails on the blackboard. And 3 the other question I have, this is one of the 4 public commenters mentioned about all of the 5 Kim data. 6 I presume that you guys are really 7 trying to get all of that data out into 8 publication so the next revision can have the 9 other subjects, the other exposures, the other 10 findings. 11 DR. SAMET: So just, one moment. 12 Just to elaborate on what Judy said. It seems 13 to me that there's again, coming out of these 14 chapters for each of the health outcomes 15 there's two bottom lines. 16 One is the strength of evidence 17 and what do we know about the concentration 18 response relationship? And those are what 19 really is critical for moving forward into the

20 REA. 21 If a causal determination has been 22 previously made, there's probably not too much

### 202-234-4433 Neal R. Gross & Co., Inc. Page 351 1 need to say what is the new pile of evidence? 2 If I'm buying the Surgeon 3 General's report on smoking and lung cancer, 4 I actually probably would not review the 100 5 new studies on smoking and lung cancer, since 6 the last, say, Surgeon General's report. 7 But I might be very interested in 8 say cigarette type or something like that, and 9 risk. It seems to me that what you get out of 10 the new information for those outcomes for 11 which there's already a causal determination 12 is new information on concentration response. 13 Perhaps an extension of the range. 14 Perhaps some new information about what 15 modifies the concentration response 16 relationship. And that's where emphasis 17 should be given. 18 If you are judging the strength of 19 evidence then, as Judy points out, and others 20 have pointed out, drawing a line on the date 21 you happen to convene the first group of 22 writers, or whatever it is, is arbitrary. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 352 1 it is the full strength of evidence that needs

2 to be done. 3 And it's not that evidence that 4 has come in the later cycle is better 5 necessarily than old evidence. Perhaps it is, 6 perhaps it isn't. But it's an increment to 7 what we know. And it's accumulative. That's 8 important. 9 So it seems to me you could make 10 those, that distinction. And not get caught 11 up in the old/new/recent, whatever's there in

12 the -- 13 DR. VEDAL: Yes. But I think 14 that's what's done, in their defense. I mean, 15 in every single instance. It's not as if 16 we're saying, okay, you know, we're operating 17 as if there's no previous data. 18 And what's done, there's a summary 19 of what we know, and then what's happened 20 since. I think that works perfectly logically 21 and is actually very useful. 22 DR. SAMET: Yes, but it's a little

### 202-234-4433 Neal R. Gross & Co., Inc. Page 353 1 -- 2 DR. VEDAL: I think that -- 3 DR. SAMET: -- more of a nuance in 4 the wording, Sverre. I don't -- 5 DR. VEDAL: I think in the 6 integrated summary, you know, that sort of 7 discussion is where this big picture comes in. 8 And it certainly shouldn't be ignored in terms 9 of causal classification. But in terms of 10 presenting, you know, new information, I think 11 it works perfectly well.

12 DR. SAMET: Fred.

13 DR. MILLER: I want to address one 14 of the points Mary brought up about square 15 wave versus triangle. In the '70s I published 16 about pulmonary function being dose rate 17 driven. And structural, morphological changes 18 being cumulative dose. 19 A Type 1 cell can only expand by 20 30 percent and then it dies. The neurological 21 aspects of the pulmonary function control in 22 that are the bombardment of the pressure

### 202-234-4433 Neal R. Gross & Co., Inc. Page 354 1 receptors. 2 And what this gives credence to is 3 why Bill McDonnell's recent model, allowing 4 the exposure pattern, the profile, while he's 5 able to model both the square wave and the 6 triangle studies. 7 So, you know, the fact that these 8 are dropped here instead of 12, 15 percent for 9 the square wave versus the triangle on Page 6- 10 7 to about six or seven percent, is a function 11 of the dose rate, okay. 12 And so to me this is another 13 example of where this aspect of dose isn't 14 being factored into these discussions. And 15 this was explainable 30 some years ago.

16 DR. SAMET: Helen. 17 DR. SUH: Well, I guess actually I 18 thought, Jon, when you were talking about it 19 you were going to go one step further, which 20 is I think why the distinction between recent 21 and old is in the document. 22 It's really to show people why if

### 202-234-4433 Neal R. Gross & Co., Inc. Page 355 1 there is a change or not a change in the 2 standard, why that is. Like, what is that new 3 information that makes you want to change or 4 stay with what the current course? 5 And I think that that's really 6 important. I think that's really important to 7 the public. I think it's really important to 8 other people to understand why was there a 9 change made. 10 So I think that no matter what you 11 have to have some distinction about how much 12 new is there so that you can know whether you 13 -- Because for example, something's causal, 14 you might want to say, well maybe it slipped. 15 Maybe there was some important piece of 16 evidence that might make you slip. 17 But you want to have that 18 documentation about what is new and why that 19 makes you want to change or not change. So I 20 agree with you. 21 In terms of causality it doesn't 22 matter. And in terms of explaining things

### 202-234-4433 Neal R. Gross & Co., Inc. Page 356 1 like modes of action or dosimetry, you've 2 really, it is the whole body. 3 But I think you can draw on the 4 whole body of evidence without having to 5 discuss each study individually. But I do 6 think you have to have in the document what is 7 new since last time. I think that's like a, 8 to me it's a given. 9 DR. BELL: I don't think anyone's, 10 I certainly was not suggesting that they 11 discuss every single study. And I was being 12 facetious when I said, you know, it could be 13 50 percent longer and still not be brief. 14 But I think where I'm coming from, 15 and where I think Judy's coming from, are 16 that, you know, just because you have new 17 studies doesn't mean you want to omit key 18 studies that you're using for the scientific 19 evidence. 20 You can imagine a situation where 21 there's almost no new studies, but you think 22 it's extremely causal. And so I think that a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 357 1 feasible way to move forward is not to 2 describe every study, but to include those key 3 studies that were prior to this review. 4 And to have, I guess this is one 5 point where I disagree with Sverre a little 6 bit. I don't think the distinction between 7 old and new is very clear. 8 I think using terms like new and 9 recent that are kind of used conversationally, 10 and going back and forth between which term 11 you use, knowing that no one other than Jon 12 Samet is going to read the whole thing, is 13 really not going to make sure that people know 14 what we're talking about. 15 So I mean, I think you can even be 16 explicit to say, you know, define what new and 17 recent mean, maybe several times. Or to say 18 this section of study since the last review. 19 Or somehow be really explicit about it. 20 But still, I would personally like 21 to see mention of some of the key studies from 22 before that we're using for scientific

### 202-234-4433 Neal R. Gross & Co., Inc. Page 358 1 evidence. But certainly not every study. 2 But, you know, as long as the 3 document is, when you tell people to go back 4 and read the 1986 document. I mean it's 5 really even longer -- 6 DR. SUH: Yes, but I don't think 7 that's what the document's -- I agree with 8 you. Maybe the key studies is the thing to 9 do. And maybe that's like put in a box in the 10 front or something. I don't know exactly. 11 But I think it is a presentation 12 kind of thing. I think we're in agreement 13 about, you know, about the issues. I think 14 it's just really a presentation. 15 But I think you can't, just as you 16 can't omit all of what's known before, you 17 also I think have to, for the document itself, 18 include what is different from last time.

19 DR. SUH: Yes. 20 DR. SAMET: Okay. Judy's got a 21 comment. And I think, John, if you have any 22 comments. And then we're going to take a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 359 1 break. 2 DR. GRAHAM: Yes. And, Helen, I 3 can agree with what you said. I'd like to 4 fine-tune it. The problem is that now all the 5 new studies are just studies there because 6 they're new. 7 They're not new ideas. They're 8 not perfections of like, which cigarette, or 9 an additional mechanisms. They're just plain

10 new. 11 And so if it were, you know, we 12 have all this whole body of evidence here, and 13 here's something brand new that has an effect, 14 makes it stronger, or whatever, then that 15 would be okay. But right now, the worship is 16 pretty much at the date. 17 DR. SAMET: John, any comments or

18 -- 19 DR. VANDENBERG: Well, I think 20 very clearly we're seeking advice. And what 21 I'm hearing is quite a range of views. I 22 would tend to offer that the approach we've

### 202-234-4433 Neal R. Gross & Co., Inc. Page 360 1 taken is very consistent with what Dr. Vedal 2 and Suh suggested, which is we provide some 3 context of the review of the prior body of

4 research. 5 Perhaps we don't get into the 6 specificity that some would like. And I can 7 understand that point of view. But we have 8 focused more on the newer studies since the 9 last review in order to actually streamline 10 the information. To focus on the newer 11 information.

12 It doesn't mean the old 13 information isn't highly relevant. It clearly 14 is. And perhaps there may be some advice you 15 could provide as to how to effectively bring 16 that in without bringing perhaps an 17 overwhelming amount of information in. 18 Because the body from before if 19 you recall, this is a streamlined ISA compared 20 to the former air quality criteria document. 21 So we have to be mindful, and we appreciate 22 your advice as to how to do that most

### 202-234-4433 Neal R. Gross & Co., Inc. Page 361 1 effectively, to bring perhaps the key or the 2 most informative studies forward in an 3 effective way. 4 DR. SAMET: Okay, Joe is last

5 word. 6 DR. BRAIN: I think the key issue 7 is this is a five-year review. How have the 8 views of the EPA and of CASAC changed? And so 9 I think, you know, it's not so much new or

10 old. 11 But I think that's what the 12 Administrator, and that's what the community 13 and the ATS wants to know is, do we have new 14 ideas about ozone and what the standard should

15 be? 16 And then to carefully select the 17 references that support the way views have 18 evolved. That may be reinterpretation of old 19 studies. Or it may be a brand new study. And 20 so we don't put something in simply because 21 it's new. But we emphasize the ones that have 22 altered our perspective.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 362 1 DR. SAMET: Okay. So it is 2 roughly 20 after. We're behind, but I think 3 we're okay. We actually have a lot of time 4 set aside at the end for discussion of 5 Chapters 1 and 2, and may not need so much. 6 So why don't we take a 15-minute break. Get

7 back here about 25 of. 8 (Whereupon the foregoing matter 9 went off the record at 3:22 p.m. and resumed 10 at 3:36 p.m.) 11 DR. SAMET: Okay, we are at 12 Chapter 8, At Risk Populations. Ana. 13 DR. DIEZ-ROUX: Okay, can you hear 14 me? Okay. So I'm going to talk about Chapter 15 8. First I should say, I think this is a very 16 important chapter. 17 It's a complex topic for a number 18 of reasons that have to do with some of the 19 concepts and terminology, as we'll discuss. 20 And also because some of the evidence is very 21 difficult to summarize. But, nevertheless, I 22 think it's a very important chapter.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 363 1 I was not part of the prior 2 review, but my sense from reading the prior 3 comments is that EPA has really tried to 4 incorporate many of the suggestions that were 5 made in the prior review regarding terminology 6 and laying out things at the beginning. 7 And I think the chapter has been 8 moving in the right direction. However, as a 9 new reader, I have some additional comments 10 that I hope may be useful in further 11 clarifying some of those issues. 12 So I'm going to make some 13 comments, some more conceptual comments in 14 terms of clarifying exactly what the chapter 15 is focusing on and what it's trying to do. 16 And then talk a little bit about 17 some of the framework and the way it's laid 18 out, and then talk a little bit about some of 19 the content. Okay? 20 So in terms of the concepts, I 21 think it's very important for this chapter to 22 clearly, and it's starting to do this, but I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 364 1 think it could be clearer, to clearly 2 distinguish two processes that place certain 3 populations at, quote, increased risk. 4 One has to do with simple 5 increased exposure. And that can be because 6 people are exposed to, you know, higher 7 ambient levels because of where they live, or 8 because they work outdoors. Or it can be 9 because they receive a greater internal dose 10 for a given ambient exposure because of 11 breathing patterns or because of air 12 conditioning or whatever. 13 The latter is manifested as effect 14 modification in epidemiologic studies, but 15 it's really just increased exposure, or 16 increased internal dose. So that's one set of 17 processes. 18 The other set of processes, which 19 is, I think, what the bulk of the chapter 20 focuses on, is processes that lead to a 21 greater adverse health effect of a given 22 exposure or a given dose. And that's what

### 202-234-4433 Neal R. Gross & Co., Inc. Page 365 1 appears in studies as effect modification or 2 statistical interaction. 3 Although, as I noted before, some 4 of the internal dose variations can also 5 appear as effect modification, but they're a 6 different phenomenon. So I would keep them 7 with the increased exposure. 8 In terms of a greater adverse 9 health effects of a given exposure or dose,

10 there are a number of factors that can lead to 11 that, as you have them in the chapter. They 12 can be from very proximal things like genetic 13 factors, to individual level behaviors like 14 nutrition, to social processes. 15 Now, my sense is that you're using 16 the term population at risk to encompass both 17 of those things. And if so, I think it can be 18 more clearly stated at the beginning of the 19 chapter. 20 And decide if you are going to use 21 the terms vulnerability, susceptibility or, 22 you know, sensitive populations et al., or

### 202-234-4433 Neal R. Gross & Co., Inc. Page 366 1 not. If you are going to use those terms, 2 then I think you need to clearly define what 3 they are. 4 Are they synonyms of population at 5 risk, and therefore encompass both processes? 6 Or are they referring specifically to the 7 second part, which is the greater adverse 8 health effects of a given exposure? 9 I think a lot of times, 10 sensitivity or vulnerability is used in that 11 way. If that's the way it's going to be used, 12 then that needs to be defined. 13 And I think it's important to be 14 very consistent in the terminologies 15 throughout the whole document, because even 16 though this chapter talks about population at 17 risk, there are numerous instances throughout 18 the both volumes using, like, sensitivity as 19 a synonym for greater adverse effects of a 20 given dose. 21 So I think that needs to be 22 clarified, and the terms very clearly defined.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 367 1 I know there's a history, you know, to this. 2 But these are just my comments as a first-time 3 reader of this document. 4 So that's the more conceptual 5 piece. I think this conceptual layout can be 6 reflected in the structure of the chapter. 7 So, for example, you could talk 8 first about factors that are related to 9 increased exposure, and perhaps that section 10 can be brief, so the piece that you have on 11 heightened exposure, for example, can be part 12 of this. And then, talk about all the factors 13 that increase the adverse health effects of a 14 given dose. 15 In talking about those factors, 16 you know, one way, and this is just 17 reorganizing material that you already have, 18 but the way it is now, you're talking about, 19 you know, one thing here and then you're 20 jumping to another, genetics and behavior and, 21 one way that you could reorganize it is go 22 from more proximal to more distal effect

### 202-234-4433 Neal R. Gross & Co., Inc. Page 368 1 modifiers, because some of the more distal 2 factors like race and SES really operate 3 through behavioral stuff. For example, 4 through more proximal mechanisms. So this is 5 not a very big point, but just reorganizing 6 it, I think, would help the flow. 7 In terms of the content, when you 8 talk about each of the sections, it talks 9 about each of the, I'm going to call them 10 effect modifiers, or each of the factors that 11 modify, that increase the adverse effects of 12 exposure. I think it's important, and you do 13 this to a certain extent, but to 14 systematically start out with our rationale 15 for why we would expect effect modification. 16 And this could allude back to some 17 of the other chapters. You know, for example, 18 to the chapter that we discussed earlier, I 19 think it was 4 or 5, which talks about, you 20 know, more biological mechanisms that could 21 result in differential effects. 22 So give a rationale for why we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 369 1 would expect some effect modification. Give 2 some information on the prevalence of the 3 condition or factors so that readers can get 4 a sense of, well how important is this at the 5 population level. 6 Review the epidemiologic evidence 7 and review the controlled experiments and 8 toxicological studies as you do. Now, then 9 have a general conclusion. 10 So it would be nice for each of 11 these sections to be very parallel in that. 12 And I think you do that to a certain extent. 13 I think a little bit of cleaning up of that 14 would help. 15 One thing that I found was that 16 sometimes the way the literature was reviewed, 17 it was difficult to get a sense of, well what 18 is the bottom line. How much evidence do we 19 really have that this is an effect modifier? 20 It read a little bit like, well, 21 there's this study and then there's that 22 study, and then there's this one. So it was

### 202-234-4433 Neal R. Gross & Co., Inc. Page 370 1 a little bit hard to conclude much from the 2 way it was set out. 3 And perhaps the conclusion is that 4 we can't conclude much. But then it has to be

5 clear. 6 So for example, one thing to 7 consider is whether it might be useful to have 8 some schema, just like, you know, we have some 9 guidelines for causal inference, to have some 10 guidelines for saying, well these are effect 11 modifiers that are well-established. Or these 12 are suggestive, but need to be studied 13 further, and there's no evidence that these 14 things so far modify. 15 I don't know, it would be 16 interesting to think about whether that could 17 be done in some way. And that would allow it 18 to connect, also, to other documents. 19 Like the subsequent documents that 20 are coming that, you know, I assume some of 21 this stuff on population at risk is carried 22 forward potentially into the other documents,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 371 1 the more policy and the risk assessment

2 documents. 3 And so it would be nice to be able 4 to have some, well what's the bottom line 5 clear conclusions that we can draw about 6 populations at risk that need to be carried 7 forward. The way the chapter is now, it's 8 hard, that doesn't really come through. 9 And as a final point, I think it 10 would also be important for the chapter to 11 acknowledge that, specifically a topic of 12 looking at effect modifiers. You know, it's 13 quite complicated to do in studies. 14 Now this is where, maybe one of 15 the reasons why we have inconsistent evidence. 16 They're issues related to, you know, 17 comparable measurement of effect modifiers. 18 Sample size is a big, big problem. 19 So acknowledging some of the 20 challenges in studying these effect modifiers 21 and looking at replicability and genetic 22 stuff. Replicability: big, big issue.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 372 1 And perhaps some of the text that 2 you have on the healthy responders, which3 really talks about unexplained inter4 individual variability and response could be 5 incorporated into that. 6 So, for example, we know that 7 there's a lot of inter-individual variability. 8 There must be some factors that explain that. 9 But we still haven't been able to identify 10 them for these, you know, number of reasons. 11 So I think that sets the stage for 12 why this is an important topic, even if we 13 don't have a lot of evidence yet to be able to 14 draw, you know, very, very firm conclusions

15 about these factors. 16 I think that's about it. Yes, I 17 think those are my main comments. 18 DR. SAMET: Okay, thanks. Judy? 19 DR. GRAHAM: I would like to 20 strongly endorse what Ana just said. And one 21 caution there is when we talk about, you know, 22 what would cause there to be a greater adverse

### 202-234-4433 Neal R. Gross & Co., Inc. Page 373 1 effect, I think it will also slash impact. 2 And that brings up the issue of 3 sometimes here we talk about, say a chronic 4 bronchitic, or smoker may be less responsive. 5 But it could be that same small change in 6 pulmonary function might have more of an 7 impact because they have less reserve 8 capacity. 9 I like the separation as exposure 10 to really strongly bring exposure in here. 11 It's not treated properly. Dose is not 12 discussed, exercise is not mentioned. Kids 13 being outside during the height of the summer 14 day is not mentioned.

15 So the focus seems to be on 16 outdoors. And yes, outdoors is there, but 17 outdoors is important because exposure is 18 outdoors. It's not -- outdoors per se is not 19 important. 20 So I think there needs to be a 21 rethinking of what exposure factors come in 22 here. And then the difficulty is doing some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 374 1 intertwining, because in come cases, a given 2 individual will have a greater adverse effect 3 to a given dose. But that person may also 4 have a greater dose. In which case, that 5 group is even of higher concern for health 6 risk. 7 I do very, very much like the term 8 at risk that you put in here. And the reason 9 I like it so much is the Clean Air Act of 1970 10 used the words sensitive sub-populations. 11 Well, what's sensitivity? 12 So, I mean, I define sensitivity 13 in a very narrow way. In fact, the way you 14 narrowly defined it here. But by saying at 15 risk, you basically create this umbrella. 16 And what it is, who should we care 17 about? What population groups need to be 18 protected? And so it's going to be very 19 important. 20 I also believe that changes that 21 you make in the earlier chapters that are 22 supportive of this are going to be quite

### 202-234-4433 Neal R. Gross & Co., Inc. Page 375 1 helpful. 2 The other question I might have 3 for you to give some discussion space to is, 4 I didn't read all the epi -- I just scanned 5 parts of it, so maybe this discussion is 6 there, I just didn't read it. But that's, how 7 do we use the epi studies conducted in foreign 8 countries compared to the U.S. situation? 9 So, let's take the case where we 10 have a perfectly terrific epidemiology study 11 in China. This is what I'm focusing on 12 because, like low SES in China had more of an

13 ozone effect. 14 Well, how's that low-SES group 15 compared to a U.S. low-SES group? There's all 16 sorts of international cultural differences or 17 even pollutant mixture differences. 18 So again, I apologize if it's 19 there, may be in a place I didn't read it. 20 But to discuss how do we use this kind of 21 information? So, that's all. 22 DR. SAMET: Okay, Steve.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 376 1 DR. KLEEMBERGER: So, again, like 2 Judy, I think, you know, those comments nicely 3 summarize some of the things I was thinking 4 about as well. I think the reorganization is 5 helpful, and I put that in my written

6 comments. 7 What I will suggest, though, and 8 Ana touched on this is that -- and we 9 discussed this earlier this morning -- is that 10 the summary, the synthetic part moving forward 11 was missing. I felt like there was a lot of 12 summaries but there was no sort of putting it 13 all together, what does this mean. 14 And I think some more work needs 15 to be put into that. I think some strength of 16 evidence, if you will for some of these risk 17 factors could be put into a table that would 18 make it easier for the reader, and whoever 19 else views this document to sort of come up 20 with a conceptual sort of, okay, so how 21 important are these factors, really? 22 And so I think that would be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 377 1 something I would recommend. I'm going to 2 speak a little bit to the genetics now. So 3 one of the points that I think needs to be 4 made as far as the genetics are concerned is 5 that ozone, as we've heard throughout the day, 6 causes lots of effects, adverse effects.

7 And at least as far as the 8 literature is concerned, it's pretty clear 9 that there are potentially different genes 10 that control these different responses. 11 So the pulmonary function response 12 genes, if you will, may be different from the 13 inflammation response genes. The cell 14 inflammatory response genes may be different 15 from the increased vascular sort of leakage 16 genes. 17 And so, you know, because of the 18 inconsistencies that you see across studies, 19 I think part of the reason these 20 inconsistencies may occur is because you're 21 probably looking at the same gene for all 22 these responses.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 378 1 Well, it's probably not that 2 simple. In fact, I'm sure it's not that 3 simple. And so these are very complex sort of 4 systems and that didn't come out in my 5 reading. 6 And if you want to include a 7 phenotype as O2 uptake or dosimetry, you know, 8 the genetic literature on that is nearly 9 completely nil. I don't think that there's 10 anything that has been done, aside from one 11 study by Gary Hatch a couple years ago that 12 looked at, I think, two or three different 13 strains of mice, and looked at the O-18 uptake 14 with exposure and found that there were 15 differences between strains. But it didn't 16 take it any farther than that. 17 These are important studies that 18 need to be done. And I think that point can 19 be made, too. I think there was lots of 20 important studies that should be done that

21 haven't. 22 And again, I don't know if this is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 379 1 our purview to do that, but I think making 2 those recommendations in the document, I think 3 is very important. I think that's all I have 4 to say. 5 DR. SAMET: Steve, could you 6 comment on the material in Chapter 5? There's 7 some discussion of genetics there, as well, 8 versus Chapter 8. And should it be brought 9 together?10 DR. KLEEMBERGER: Oh, the gene11 environment interaction kinds of things? 12 Actually, I think it's probably fine as is. 13 I guess I don't feel strongly 14 either way. I think it's fine as is, but I 15 could also see where you might want to lift 16 that and put it into the other.

17 DR. SAMET: It sort of made sense 18 for me to bring it together in one spot. 19 DR. KLEEMBERGER: Again, I don't 20 feel strongly either way. 21 DR. DIEZ-ROUX: The same applies, 22 I think there's a discussion of nutrition as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 380 1 a modifier in Chapter 5, as well. And this is 2 highly relevant to the mechanisms in this 3 chapter. 4 So I think you need to decide 5 where is that going to be discussed more in 6 depth, and the other place can just refer to 7 it. 8 DR. SAMET: So, others want to 9 comment on this chapter? Yes, Fred. 10 DR. MILLER: I have three quick 11 comments. It's late in the day, and I'm glad 12 that the EPA authors are interested in sex. 13 But I really think that 816, it should be 14 gender, not sex as the subsection title, if 15 we're going to sort of be a little bit more 16 sensitive. 17 Some people think I'm sexist, I 18 guess. I don't know. At any rate, I just 19 think it should be changed to gender rather 20 than sex as the title for the section. 21 But there's a study that's cited 22 here in California on poverty levels, when you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 381 1 get into the SES. And I bothered to go get 2 the study and read it. 3 And they talk about greater 4 effects when you have less than seven percent 5 in terms of the SES level and between it. 6 There was absolutely zero in that paper as to 7 how they picked those levels. 8 And I feel almost 100 percent 9 certain it's the same as the Von Neiding NO2 10 studies 35 years ago that, that after the fact11 went and divided them into responders and non12 responders. 13 There is zero in here on 14 justification for how they created those SES 15 categories. And I would throw that paper out. 16 I mean, if you get that kind of 17 paper published without an explanation of your 18 methodology, then I got to really worry about 19 the journal. So, I think you should take a 20 look at that, because it just doesn't stand 21 up.

22 And the last comment has to do

### 202-234-4433 Neal R. Gross & Co., Inc. Page 382 1 with exercise that -- didn't exercise at all, 2 and a statement here on page 826 where it 3 compared to those that exercised at least once

4 a month. 5 Okay, now is that a typo? I mean, 6 because, you know, please don't talk to me 7 about being able to delineate zero versus one 8 exercise a month. 9 I've gotten into a heavy physical 10 exercise activity and lost 30-some pounds 11 recently. You know, and I'm going five days 12 a week. And I'm telling you, you know here 13 this one exercise once a month. And in fact, 14 there's other studies that show if you only 15 exercise on the weekend, you're at greater 16 risk for cardiovascular. So give me a break 17 about some of these things. 18 And the kind of scrutiny for some 19 of the stuff in here, I think needs to be

20 elevated. 21 DR. SAMET: Well, I don't want to 22 disagree with you, Fred, about sex. I think,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 383 1 in fact, if you refer to the XY chromosome, it 2 is sex, and if you're referring to choice or 3 preference, it's gender. 4 So I actually think sex may be the 5 right word here. I would defer to any other 6 expert on sex and gender around the table. 7 But, I think I've got it right. 8 DR. DIEZ-ROUX: Sex is usually 9 used when you are referring to biological 10 factors that have to do with hormonal or 11 chromosomal stuff, whereas gender's a broader 12 concept. 13 DR. MILLER: So sex is divided to 14 male versus female responses. So isn't that 15 gender? 16 DR. DIEZ-ROUX: Depends, it could 17 be both, actually. It depends on what the 18 mechanisms that they're talking about are. If 19 they are mostly biological, then it should be

20 sex. 21 DR. MILLER: All right. I 22 probably brought it up just to kind of lighten

### 202-234-4433 Neal R. Gross & Co., Inc. Page 384 1 the end of the day, but okay, whatever.

2 DR. SAMET: He succeeded. Helen. 3 DR. SUH: It's just a quick 4 comment. Reiterating what Judy said, I think 5 in the front part of this chapter there was a 6 discussion about evidence from which chapters 7 were included and it didn't mention exposure. 8 But exposure's so relevant to the 9 chapter that I think it should be very 10 explicit inclusion. And then, you know, 11 especially when they talk about things like, 12 you know, the more exposed, I forgot what it 13 was called, highly exposed -- heightened 14 exposures and things, so I think it has to be 15 called out that explicitly that you drew on 16 results from that chapter. 17 DR. SAMET: Anybody else? 18 DR. MILLER: There's still a 19 little confusion, as you said, between 20 exposure and dose. 21 DR. SUH: Yes, I did have to say, 22 I thought it was very elegant, the way you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 385 1 dealt with the susceptibility and 2 vulnerability. I thought that was very nice, 3 actually. 4 But, there is still a lot of 5 confusion. Even with that, there is a lot of 6 confusion and overlap. But I did think it was 7 a very clever way to skirt the issue. 8 DR. SAMET: I think a couple of 9 the big-picture comments, the reiteration -- 10 and one is up front description of processes, 11 which you took a step towards doing. I think 12 we could do it better and more fully. 13 And it would probably be useful to 14 get it done well. I mean, there's always a 15 Chapter 8 or a chapter on at risk populations, 16 and I think there's been a lot of struggle, 17 and some evolution in your approach to this.

18 But to even draw out what these 19 processes are, I can think of lots of pictures 20 to illustrate them. Modifiers of dose given 21 exposure. I mean, there's lots of ways you 22 could show this, and I think you could expand

### 202-234-4433 Neal R. Gross & Co., Inc. Page 386 1 what's up front. 2 I think a couple of paragraphs on 3 the difficulty of investigating, you know, 4 effect modification, whatever you want to call 5 it, would also be useful. And I think the 6 determination of whether there is or is not 7 effect modification is very often rather ad

8 hoc. 9 And I think to the extent that you 10 could say, here's how we approached assessment 11 of this, I mean there are a few extreme 12 examples where there's no question, but very 13 often the information is a little bit soft. 14 And I think if you said that, and 15 then you could come up with some sort of, you 16 know, a couple of descriptors that you used 17 consistently, very simple, that that would be 18 a real step forward. 19 I have one other comment to Judy, 20 I think it's probably, we're going back to our 21 child -- that if you think that kids are out 22 at midday playing in the heat of the sun, I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 387 1 think they're indoors playing video games. 2 But, maybe somebody more contemporary could 3 update me.

4 FEMALE PARTICIPANT: Once a month. 5 DR. SAMET: Yes. Out with Uncle 6 Fred. Okay, anything else on this? Okay,

7 thanks. 8 So let's go on, at last. The 9 group's waiting patiently hearing all this 10 human health stuff, waiting to get to the real 11 thing. 12 DR. WEATHERS: Okay, I think the 13 gender-free chapter. So I thought what I 14 would do is give some overarching comments 15 about this chapter based on what it is that I 16 read of David and Howard's comments. 17 I didn't see any from Peter. I'm 18 not sure if there are any coming. Most of 19 mine have to do with specifics and not the 20 overarching pieces. And then I'll have you 21 guys chime in. 22 So I think it's fair to say that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 388 1 we all that the EPA has captured well and 2 responded appropriately to our issues of 3 concern last time around. None of us 4 identified, at least in our written comments, 5 any major changes that were necessary. 6 And that's probably not surprising 7 since most of the conclusions are also 8 supportive of the 1996 and 2006 conclusions. 9 We actually just had a quick 10 conversation as we were talking about 11 integration of the new and old data. And I 12 think we three think that this chapter did it 13 quite well. So this is a good example, I 14 think, for integrating the old and the new. 15 The last section, the summary and 16 summary table, I thought, anyway, were 17 particularly good, and quite useful and 18 integrative, as well. 19 And I certainly appreciated the 20 identification of future needs in many of the 21 summary sections. I think that that's a 22 useful piece of information to capture.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 389 1 There were a few challenges, I 2 think that were overarching. As with many of 3 the other chapters, there's some sections that 4 still could use some technical editing, and I 5 think David and I both commented on that. 6 There's certainly some confusion 7 still about how scale is used and even, from 8 my perspective, how ecosystem is used. And it 9 would be helpful to add definitions and 10 explanations for some of the terms in my world 11 of being a frustrated accountant. 12 It's the accounting terms like 13 defining gross primary production and that 14 ecosystem production and respiration and the 15 relationship among all of those. And it 16 becomes quite relevant when comparing model 17 results for ecosystem responses to ozone. 18 But there are some in the 19 vegetation and the community and population 20 scale, too. 21 And there was a comment earlier 22 today, and I don't know if we want to take up

### 202-234-4433 Neal R. Gross & Co., Inc. Page 390 1 or not about some opportunities to contrast 2 and compare plant and human exposures and 3 responses.

4 And so I throw that out to our 5 group and to the rest of the group as, is 6 there something that might be done there. And 7 I would think that it would be in the front 8 materials where it might be done. So those 9 are overarching comments. David? 10 DR. SAMET: Okay, David? 11 DR. GRANTZ: I guess I would start 12 out by saying that I really do feel like staff 13 listened very carefully to the things we said. 14 And as I read through this chapter, I was 15 really very, very pleased. 16 I think there were some problems 17 before, it reads much better now. Things are 18 more consolidated along the lines that we 19 suggested. 20 I had a couple of points that I 21 think, mostly I had mentioned before, and I 22 think weren't taken up. One is this business

### 202-234-4433 Neal R. Gross & Co., Inc. Page 391 1 of sensing ozone. I am just not convinced

2 there's an ozone sensor. There's a cascade of 3 oxidant impacts. 4 But there is no ozone sensor. And 5 that comes up several times, at least. So I 6 think that should probably be reworked a 7 little bit. 8 We did have a discussion, the 9 three of us, on this business of old versus 10 new. And I do think, mostly, the chapter does 11 a good job. But I think I differ a little bit 12 with Howie and Kathy on, there are numerous 13 times where it's stated that in the previous 14 criteria document, this was discussed, rather 15 than, these are the conclusions upon which we 16 build the rest. 17 And it's just, you know, it's 18 textual laziness, basically. But I think you 19 should go back through and look for those 20 places, because this document really does have 21 to stand alone. I don't want to go find the

22 old CD.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 392 1 You know, you don't have to cite 2 all the studies. You should certainly cite 3 the conclusions that you're going to use. 4 I think EPA did a really nice job 5 of corroborating the old open-top chamber data 6 that's elaborated upon in some detail. And I 7 think that's just critically important, as I 8 think we all said the last time around. 9 And then the only other thing that 10 I want to emphasize from my written comments 11 is this business of ozone impacts on root 12 growth. And I say specifically in my written 13 comments that the conclusions in 9431 and 9432 14 are very, very weak considering how well we 15 really know that ozone impacts allocation 16 below ground. I mean, the meta-analysis that 17 we published in 2006 pretty well establishes 18 that for a large number of species. And yes, 19 of course, there are some studies that don't 20 find it. There may even be some species that 21 don't exhibit it, although I doubt it, but 22 there may be.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 393 1 But overall, it definitely does 2 impact carbon movement below ground. Now, in 3 those sections, the question is whether we can 4 demonstrate reduced sequestration of carbon 5 below ground. And that is a separate 6 question, and it should be kept separate. 7 Now, reference is made to the 8 Rhinelander, Wisconsin study wherein at some 9 time point during the five or six years, an 10 actual increase in fine roots below ground was

11 observed. 12 But as you note, that was a 13 community level response. It doesn't negate 14 the fact that ozone really does inhibit carbon 15 movement below ground. 16 What you're claiming is that if we 17 can use ozone to drive sensitive species out 18 of the population, that we'll get more carbon 19 below ground. Well, that's not a direction 20 you want to go. 21 If you want to explain community 22 level and population change impacts on any

### 202-234-4433 Neal R. Gross & Co., Inc. Page 394 1 endpoint, including carbon sequestration, 2 that's fine. But I think you should do that 3 explicitly. I think you missed the point 4 there a little bit. 5 And the rest of it, I think is in 6 my written comments. Thank you.

7 DR. SAMET: Howard? 8 DR. NEUFELD: Well, being the 9 third person in a row, much of it's been said. 10 But again, I want to compliment you on the 11 revision of this chapter. Almost every 12 comment I remember making on the previous one 13 has been addressed in this revision. So it's 14 done very well. 15 So, I'm just going to go through 16 real briefly what I wrote here. Just a few 17 things. On page 9.3, you state that there 18 have been really no methodological 19 advancements since 2006 that have 20 fundamentally altered our understanding of 21 ozone effects on plants and ecosystems. 22 I think that's a little too

### 202-234-4433 Neal R. Gross & Co., Inc. Page 395 1 strong. I mean, we haven't had much funding, 2 and sure, there isn't a lot of breakthrough 3 technologies, but there's been a few. 4 Like Nancy Grulke's apparatus to 5 simultaneously measure gas exchange while 6 supplying ozone to leaves, that is a 7 methodological advancement because that's a 8 very technically difficult thing to do. 9 I was really pleased, as David had 10 mentioned, about your pulling together the 11 exposure responses from plants done in a 12 variety of different ways, like in CSTRs and 13 open top chambers and so on. I think your 14 analyses clearly show that the results from 15 those early studies still have a lot of

16 relevance. 17 And in that, there was a lot of 18 internal consistency among these various 19 exposure methodologies. I think that's an 20 important point that you made. 21 And also, when you were discussing 22 the results of the open top chambers and face

### 202-234-4433 Neal R. Gross & Co., Inc. Page 396 1 and gradient studies, you mentioned the 2 possibility of chamber effects when you're 3 using open top chambers. 4 And indeed, many people do find 5 them, but there's also many instances where 6 you don't. I list some in my written comments 7 here where we specifically looked at a chamber 8 effect and either found very few effects or

9 none at all. So that the results from the 10 open top chamber studies seem to be quite 11 valid. 12 I particularly liked the section 13 on page 921 when you started to discuss 14 proteomic and transcriptomic studies. They

15 were well done. 16 This is a relatively new area of 17 research in the ozone area, and you got the 18 major patterns out there in a nice, readable 19 way, especially for those of us who are not 20 molecular biologists. 21 And I just want to ask you a 22 question to colleagues here on the other side

### 202-234-4433 Neal R. Gross & Co., Inc. Page 397 1 and all over here. I couldn't find any 2 mention of similar studies done on either 3 animals or humans. So is that because there 4 aren't any, or did I miss it? So I just throw 5 that out as a question. 6 MALE PARTICIPANT: What kind of 7 studies? 8 DR. NEUFELD: Like arrays, you9 know, what genes are up-regulated and down10 regulated upon exposure to ozone? 11 DR. KLEEMBERGER: In the animal 12 literature, there's a lot.

13 DR. NEUFELD: Is there?

14 DR. KLEEMBERGER: Yes. 15 DR. NEUFELD: Okay. All right. 16 Is it in this document? That's what I was -- 17 DR. KLEEMBERGER: One paper is. 18 DR. NEUFELD: Yes, well anyway, I 19 just point that out. In section 9.4.2, I 20 think you could maybe just beef up the 21 discussion a little bit on genetic variation 22 to ozone in non-crop species.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 398 1 For example, there's Somers, et 2 al., and Chappelka, et al., and Souza et al., 3 which show a lot of genetic variation in 4 herbaceous and woody plants in the native 5 plants as opposed to crop plants. 6 The meta-analysis that Wittig et 7 al. did in 2009 shows a seven percent 8 reduction in growth with ozone as low as 40 9 parts per billion. Perhaps that's worthy of 10 a little more discussion because they say in 11 their paper that they expressed that relative 12 to growth in charcoal filter controls. 13 So, given the discussion we've had 14 here about background ozone and the use of 15 charcoal filter controls, maybe that section 16 needs to be looked at again. In all the tree 17 studies I did in the Smokies, we didn't find 18 any measurable effects on growth at ambient or

19 below. 20 I was pleased to see that you 21 included the lower plants, like mosses and 22 lichens. They may be small in stature, but

### 202-234-4433 Neal R. Gross & Co., Inc. Page 399 1 they cover a large portion of the earth.

2 You refer to the trees and the 3 AspenFACE site at Rhinelander as a forest in 4 Wisconsin. Every single one of those trees 5 was planted and there are, maximum, only three 6 different species in the mix diversity forest. 7 So I think you should refer to it as an 8 artificial or planted forest. 9 And in the summary, 9.4.3.2, the 10 last paragraph, you might consider modifying 11 the conclusionary sentence. I think it's 12 important to stress that many ozone effects on 13 native vegetation in the field have been found 14 at ambient levels, which would distinguish

15 those effects that are found at elevated ozone 16 under controlled conditions. 17 And lastly, I was pleased to see 18 you discussing sluggish stomata. This is a 19 fairly new response. But you suggested in 20 there, in the writing, that that could lead to 21 greater water loss. 22 And I want to just point out the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 400 1 possibility that it could actually, maybe end 2 up not, because by the time the stomata 3 becomes sluggish, they may have partially 4 closed to a great deal, so that they're 5 actually letting off less water. 6 So you might actually get less 7 water loss, even though the stomata have 8 become unresponsive to changes in the 9 environment. So maybe you could just slightly 10 modify that section. 11 And the rest, I would say is well 12 written, and good job. Thanks. 13 DR. GRANTZ: Okay, I had one -- 14 DR. SAMET: Yes, sure. 15 DR. GRANTZ: One thing that I 16 forgot to say, I think the emphasis on 17 photosynthesis, which is one of the earliest 18 effects that we knew about, is well founded. 19 And I think that's important.

20 There's a lot of recent work on

21 stomatal conductants and the document 22 accurately says there can be direct and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 401 1 indirect effects on stomata. But the indirect 2 effect is entirely by intracellular CO2. And 3 I think that's wrong. 4 You know, we know that abscisic 5 acid, for example, defuses from the mesophyll 6 and impacts stomatal conductants. There's 7 probably a lot of that going on. 8 So to focus solely on CO2 and to 9 call that out is probably just -- simply can 10 be deleted. I don't think you need to even go

11 there. 12 There are definitely mesophyll 13 effects on guard cells and there are direct 14 ozone effects on guard cells. And we don't 15 know very much about either one. 16 DR. SAMET: Okay, comments from 17 others. Sverre? That's a no. Okay, any 18 comments from others on this? Yes? 19 DR. MILLER: I got a quick one, 20 you win the award for the most references, 33 21 pages. But yet it's not the longest in text. 22 So obviously it was very well

### 202-234-4433 Neal R. Gross & Co., Inc. Page 402 1 written. And maybe that's an example for 2 others to follow in some of the, like 6 and 7? 3 DR. WEATHERS: Yes, what I was 4 saying was that there are some great tables, 5 synthetic tables in this chapter, to be

6 commended. 7 DR. SAMET: Good, got your praise. 8 I will say in reading about the early days of 9 air pollution in L.A., the effects on 10 agriculture were extraordinary. I mean, it 11 caused a revolution in what people were doing, 12 thinking, raising. If I've got this story 13 correct, probably still does. 14 Okay, good. Thanks. So I guess 15 we can move on and we just almost caught up. 16 Let's see, so then we're up to the Chapter 10. 17 DR. JACOB: All right, so Chapter 18 10 is about global perspectives involving 19 ozone as a climate gas, and also UV effects. 20 And it's a much shorter version from what was 21 in the first draft of the ISA. 22 And overall, I think it's all

### 202-234-4433 Neal R. Gross & Co., Inc. Page 403 1 right. I have a number of comments that are 2 in the written record and I'll edit them. But 3 I wanted to just hone in on three issues, 4 which I think are important. 5 The first one is that this chapter 6 misses an opportunity to more clearly state 7 how emission controls, relevant to ozone 8 pollution, will impact climate change. 9 There's a lot of discussion of this in the 10 latest IPCC report, which was, you know, out 11 in 2007. 12 The message is actually fairly 13 complicated. For example, NOx emission 14 controls are thought to be climate-neutral 15 because of cancelling effect. CO and VOC 16 emissions are, emission control is very 17 expected to have a climate benefit. 18 But the most important climate 19 benefit to have is, of course, reduction in 20 methane emissions, which also will have an 21 effect on ozone pollution. There are charts 22 on this in the IPCC report. Bar charts that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 404 1 I think would be very useful to include in 2 this chapter. 3 In particular, there's a bar chart 4 in the IPCC report that shows that over a 20- 5 year horizon, methane emissions are more 6 important in terms of warming than CO2 7 emissions, which is something that's really 8 interesting. 9 And as EPA goes more and more into 10 trying to meet both air quality and climate 11 objectives, methane definitely needs 12 consideration. And I think this could be more 13 prominently advertized in this chapter.

14 That's comment number one. And15 also the fact that NOx emissions are climate16 neutral. 17 Comment number two has to do with 18 future emission projections. There's a 19 general tendency in this chapter to say that, 20 well the situation with global tropospheric 21 ozone is likely going to become worse. In 22 particular because of increasing emissions in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 405 1 Asia, and so on. 2 Well, that was the message one 3 could have gotten from the last IPCC report. 4 But the upcoming IPCC report, AR5, is going to 5 show a very different pictures. 6 And in particular, the emission 7 scenarios for the 21st century, which had not 8 been updated since 2001, the third IPCC 9 report, will be totally changed. We won't 10 have the SRES scenarios anymore. We will have 11 the RCP scenarios. 12 And this is already published in a 13 variety of documents and a very important 14 feature of those RCP scenarios is that the 15 emissions of ozone precursors on the global 16 scales are all going down. 17 Emissions of NOx are going down. 18 Emissions of CO are dropping like a rock. 19 Emissions of VOCs, also emissions of methane 20 are becoming flat and then going down. 21 The point is that if you run these 22 RCP scenarios for a model, you will find that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 406 1 global ozone is going to be going down in the 2 coming decade. So a very, very different 3 message then what we've had in the past, and 4 what is still reflected in this chapter. 5 So I think this needs to be 6 changed, because it has very important 7 implications for what we think about in terms 8 of ozone as a climate gas and also in terms of 9 intercontinental pollution, which is not a 10 really topic of this chapter. But still, I 11 think that message needs to come across. 12 Finally, the last important point 13 I want to make is about ozone in terms of it's 14 impact on UV-B at the surface. This is 15 actually a very simple problem. This is a 16 simple radiative transfer calculation. 17 And it seems to me that this 18 chapter could be more conclusive about the 19 fact that the effect is really very, very 20 small. It cites a study done by Sasha 21 Madronich which did a radiative transfer 22 calculations for emission control strategy,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 407 1 concluded that the effect is very, very, very

2 small. 3 And then it cites a few field 4 studies that show that the effect is 5 insignificant. 6 But then, at the end of the 7 chapter, the conclusion is that, while the 8 effect is expected to be small, it cannot yet 9 be critically assessed within reasonable 10 uncertainty. 11 Well, I don't think that's 12 correct. I think we can be a little bit more 13 direct and say the effect is very small. So, 14 that's a summary of my comments. 15 DR. SAMET: Okay, thank you. Ted? 16 DR. RUSSELL: Just to pick up from 17 what Daniel said is that my thought on the 18 section on the UV impacts on human health was 19 that, even though it wasn't that many pages, 20 you know 10.4.5, whatever, it still was 21 rambling. 22 And it seemed like you were trying

### 202-234-4433 Neal R. Gross & Co., Inc. Page 408 1 not to get to a point of being a bit more 2 quantitative. And I would go beyond what 3 Daniel said about it's very small, give me an 4 idea of how small it is, because I think you 5 probably can do that. 6 And if indeed you think it's just 7 too uncertain, what I would like to know is 8 what part of the process is too uncertain. As 9 Daniel put it, the radiative transfer 10 calculation is really easy. 11 So what part of this whole process 12 is not understood well enough for you to be 13 able to adequately quantify it such that you 14 can put in and say it is this small and 15 compared to the benefits, we can neglect them? 16 I want to get a feel for the magnitude there. 17 DR. SAMET: But yet, actually in 18 the summary, it says there are potential 19 benefits and it lists awesome things that read 20 a little bit speculatively to me. So, you 21 know, I think your point is it needs to be 22 brought together.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 409 1 And if you're claiming small, then 2 you come back and say the potential health 3 benefits, insulin dependent diabetes mellitus 4 for example, I think that's probably a bit of 5 a reach. So I think this needs to be 6 tightened up. 7 Other comments on this? Okay, 8 good, thanks. All right. So now we're really 9 caught up. Which brings us to the sort of the 10 front matter, Joe, so this is with you. 11 So we have, looking at the 12 Preface, Preamble, Executive Summary and 13 Integrative Overview. 14 DR. BRAIN: All right. I'll do my 15 best to maintain the momentum that we've had 16 and deal with macroscopic issues. So as Jon 17 said, there are really four pieces. There's 18 the Preamble, the Preface, and then Chapters

19 1 and 2. 20 And I feel very strongly that, 21 again, this is really a major advance and the 22 document is much better because of these four

### 202-234-4433 Neal R. Gross & Co., Inc. Page 410 1 pieces which really represent a drastic 2 reorganization of the document. 3 So they're really excellent and 4 definitely in the right direction. So let me

5 now make a few comments about each one. 6 So the Preamble, as you may 7 remember, is the document that really supports 8 not only this ISA, but we liked it, we've 9 talked a little bit about it, because it 10 really supports any pollutant. So it's a 11 general approach. 12 And again, I would really repeat 13 what I said at the beginning. It would be 14 nice to refine it, review it, publish it, 15 distribute it. It should have authors, 16 perhaps KSAC should endorse it. 17 It should not simply, you know, 18 exist as one little tiny piece that people may 19 ignore in these two volumes. But it really 20 deserves wider distribution. 21 And it has, you know, lots of good 22 things in it. It has the framework for causal

### 202-234-4433 Neal R. Gross & Co., Inc. Page 411 1 determination. It also occurred to me, are 2 there other things that are generic that 3 should either be here or in another document? 4 In that category is the whole 5 issue of vulnerability and susceptibility, and 6 how do we define those terms, and exposure and 7 dose. So I really like this approach. It 8 would be nice to have, you know, a small

9 number of core documents that the EPA and KSAC 10 and the public could refer to. 11 The only thing that I would object 12 to a little bit, just to pick out one thing, 13 is on page LV, the paragraph begins by saying 14 that, "The most direct evidence of a causal 15 relationship between pollutant exposures and 16 human health effects comes from human exposure 17 studies." And I think it's really unnecessary 18 to award that category first prize. 19 And again, I mean, the paragraph 20 goes on to detail some of the problems, you 21 know, not a range of ages or susceptibilities. 22 And in fact, it seems to me the biggest

### 202-234-4433 Neal R. Gross & Co., Inc. Page 412 1 deficiency of experimental clinical exposures 2 is perhaps not emphasized enough, and that's 3 the fact that the outcomes, by definition, 4 must be trivial if it's an ethical study 5 approved by a human IRB. 6 And so I think, you know, the 7 things that really concern us are driven much 8 more by the EPI or by the animal tox studies. 9 This really drives our concern. It's not the 10 relatively modest irreversible things that are 11 seen in clinical studies. 12 So that's just one comment. But 13 otherwise, I think it's really good. And in 14 fact, you know, it's so good that it should be 15 better and should stand on it's own and be 16 available. 17 Just one final thing, sort of the 18 very last section are two pages about 19 ecological effects. And so, you know, if our 20 plant people haven't looked at those two 21 pages, I think that would be useful to get 22 your input.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 413 1 You know, does it do a good job in 2 laying out a foundation for all pollutants in 3 relation to ecological effects? So it would 4 be nice to have you give some advice there as

5 well. 6 On to the Preface. The Preface, 7 you know, perhaps needs a better name. It 8 seems to me it's really a historical 9 perspective. And which I found, you know, 10 very useful. 11 It really lays out the history of 12 ozone regulation, and shows how the standard 13 has changed. So I found it very, very useful. 14 One question that I had, I wasn't 15 sure why the last event date mentioned was, 16 you know, March 27, 2008. That's almost four 17 years ago. Why not the latest --

18 MALE PARTICIPANT: Obama

19 statement?

20 DR. BRAIN: -- Obama statement? 21 You know, why not conclude with the events 22 leading up to the Obama decision? Because I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 414 1 sort of looked at it as, you know, really a 2 comprehensive, you know, how did we get to

3 where we are now? 4 So I think to add that most recent 5 history would be very useful. It's also a 6 good place, by the way, the references are 7 really all the key references including, I 8 think a complete list of every EPA document 9 relating to ozone. 10 So, again, you know, we've heard 11 some complaints about well, you know, it's in 12 an earlier EPA document. This is the place to 13 look. And that did, for me, raise another 14 question. As I understand it, you know, 15 clicking on those blue references gives us 16 access to all these references, but that's not 17 yet available to the public? 18 And so again, I mean, I look at 19 this as a chapter that would be useful, and 20 would hope that at some point, you know, 21 everybody who wants it could have easy access. 22 Was there a response?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 415 1 DR. VANDENBERG: Yes, the HERO 2 system allows access to the public to an 3 abstract and the bibliometric information. It 4 does not provide for published studies, the 5 actual papers, because that would be in 6 conflict with copyright. 7 So the peer review panel has 8 access to everything, just like the EPA staff 9 has. But that's limited to the review of this 10 document, because that's part of doing 11 government business, if you will. 12 DR. BRAIN: So it's really a 13 financial issue. But probably an exception to

14 that would be -- 15 DR. VANDENBERG: Well, it's more 16 of a legal one.

17 DR. BRAIN: -- all the EPA 18 documents. So maybe, because again, it would 19 be nice if anybody who wants to could access. 20 I mean, there's a list of, you know, 30 21 documents at the end of the chapter. 22 So maybe there could be some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 416 1 exceptions that would be practical and not get 2 you into trouble with greedy publishers. 3 DR. VANDENBERG: Copyright. 4 DR. BRAIN: So, I think that's the 5 Preface. Very, very useful. Then we get to 6 the Executive Summary. And I think, you know, 7 both of us in minor comments, all of us will 8 have some suggestions about it. 9 But in general, I found it, you 10 know, very useful, very effective. It will be 11 valuable for everyone, but also for lay 12 readers, legislators, you know, for everyone. 13 It's 17 pages long. So I think 14 that's a good length. It's, you know, long 15 enough that it can have a little bit of meat 16 in it, and yet it's not so long that people 17 can't and won't read it. 18 One of the problems that I hope we 19 can fix is it has no references, and it has no 20 links. So I could easily imagine, you know, 21 somebody reading the little piece on human 22 exposure, or on populations at increased risk.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 417 1 I mean, you know, they're nice little summary 2 paragraphs. 3 But, if you really want more, if 4 something really strikes your fancy, you don't 5 know how to find it. And so, in a sense it's 6 nice, it's uncluttered, easy to read. 7 But it would be nice, and I think 8 probably the solution is the one that you use 9 in Chapter 2, where you then give the citation 10 of other parts of the document. You know, 11 Table 5 in Chapter 5. Or, you know, see 2.4 12 or 3.6.12 or something like that. 13 So I think that was one problem 14 that I found. It seems to me it should be 15 possible to go from the Executive Summary to 16 other parts of the document, if you really 17 want to see more information. 18 One missing part that I find 19 complicated, contentious and important is the 20 policy relevant background. And I sort of 21 looked through that and there's maybe a brief 22 illusion to it. But I think that to have a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 418 1 little paragraph about that would be useful. 2 Finally, let's turn to Integrative 3 Overview, Chapter 2. Again, I think it's a 4 step in the right direction. I liked it 5 because it has links. Again, if you really 6 wanted more, it told you just where to go in 7 the rest of the document. So, that's, you 8 know, that worked very well. 9 Again, I sort of looked for stuff 10 about the policy relevant background. I 11 looked for more about children, about 12 susceptibility. 13 Another question is very on, pages 14 2.2-2 and 2-3, there are two pages of 15 questions. Lots and lots of questions. I 16 don't know, there must be 30, 35 questions or 17 something. 18 And it sort of slows down the 19 document. And it sort of raises, you know, 20 are these questions going to be answered? 21 There were, also, I thought, some 22 generic questions that perhaps could be swept

### 202-234-4433 Neal R. Gross & Co., Inc. Page 419 1 into the Preface or in another one of, you 2 know, the small number of freestanding 3 documents. I mean, it raises some general 4 issues that would apply to any periodic review 5 of a criteria pollutant. 6 So, I thought maybe that deserved 7 a second look, that long litany of questions, 8 to reduce it. And perhaps put some in another 9 place, because, you know, there really wasn't 10 the promise that all these questions would be 11 answered. Certainly not in any organized way. 12 So that's my macroscopic view of these four 13 pieces. 14 DR. SAMET: Thanks, Joe. Sverre? 15 DR. VEDAL: So I'm going to take a 16 little bit more of a microscopic view. But I 17 agree with what Joe has said. 18 The only macroscopic point I'll 19 make, and you've heard it before, is that 20 about the integrative summary, which, you 21 know, and this is a constant refrain about 22 emphasizing the integrative aspect of that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 420 1 And, you know, this can make 2 comparison to the PM integrative summary, and 3 this one does not compare to that in terms of 4 the integrative function. 5 I'm not going to say anything any 6 more than what's been said about the Preface 7 and the Preamble. I will say something about 8 the Executive Summary. 9 Again from more of a micro thing 10 because there are some important points, I 11 think, because this is a summary, and it 12 should fairly reflect what's in the ISA. 13 You know, in Table 1.1, you go 14 through the various endpoints and then the 15 causal assignment. One thing that had been a 16 bit puzzling, it comes up in a couple places 17 is CNS effects, where it's always claimed that 18 there's the data are not available for that. 19 Where there's actually a lot of 20 data available and therefore it's given an 21 assignment of inadequate. I think you need to 22 look at that again, because it comes up in the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 421 1 Executive Summary and it comes up later. 2 DR. BRAIN: It says suggestive of 3 a causal relationship for CNS, so short and 4 long term, in table 1.1.

5 DR. VEDAL: I have data for that. 6 There's something that troubled me about the 7 table. Which page is it on? Anyway, I'll 8 come back to that. There's something that

9 troubled me. 10 The other one that had to do with 11 UVB radiation. Now I must be missing 12 something here, because again, there was the 13 issue here is that it looked to me that it was 14 causing no health effects, where I would have 15 thought there's obvious health effects to UVB 16 exposure. This is on table 1.1-3. 17 DR. BRAIN: Oh, by the way, sorry. 18 It does need work because even though it does 19 say suggestive of a causal relationship, the 20 -- oh, I see, it's conclusions from the 21 previous review. 22 DR. VEDAL: Oh, yes.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 422 1 MR. YEOW: Joe, can you use your 2 microphone? 3 DR. BRAIN: Oh, sorry. But it is 4 confusing. How can there be evidence 5 regarding -- 6 Mr. YEOW: There we go.

7 DR. BRAIN: -- effects was not 8 available but then how does that fit with 9 suggestive of causal relationship that, see 10 it's totally, something seems wrong. Sorry. 11 DR. VEDAL: Yes, and that's 12 carried over onto other -- 13 MALE PARTICIPANT: Sorry, 1-1? 14 DR. BRAIN: Yes, Table 1-1. 15 DR. VANDENBERG: Yes, it's Table

16 1-1. 17 MALE PARTICIPANT: Are there long 18 term effect? I mean long term? 19 DR. SAMET: It's from previous 20 review, I think.

21 DR. VEDAL: What's that? 22 DR. SAMET: The one you're

### 202-234-4433 Neal R. Gross & Co., Inc. Page 423 1 pointing to with no evidence is the previous 2 review. 3 DR. VEDAL: Oh, yes.

4 MALE PARTICIPANT: One wonders

5 whether that's correct. 6 DR. VEDAL: All right, some 7 points, I think, that need some clarification. 8 For example, there's a statement that ozone's 9 been consistently associated with total and 10 cardiopulmonary mortality.

11 That's the case for short term 12 exposure. But not the case for long term 13 exposure. So it just needs to be qualified. 14 Then the issue of threshold comes 15 up. And this is admittedly thorny, and it 16 depends a little bit on where you place the 17 acute lung function responses and some other 18 physiological and other responses in the

19 context. 20 It's repeatedly said, and it's 21 important here in the Executive Summary that 22 there's no discernable threshold. That's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 424 1 clearly based on the epidemiological data. 2 If you were to take the controlled 3 human study perspective, you might not be so 4 obvious, it might be not so obvious you want 5 to make that conclusion. And so I guess I'm 6 suggesting that it might have to be qualified. 7 And I made a couple of points regarding that. 8 Also the final point about the 9 Executive Summary has to do with 10 susceptibility, where I think again, it's too 11 strong. 12 You say that there are definitely 13 definite, you know, susceptible or whatever 14 word, descriptor you want to use. When I 15 think you should be qualifying that, that 16 these are potentially susceptible. 17 There's a figure, and it's figure 18 1-1 which is the whole thing about atmospheric 19 chemistry and the stratosphere and then the 20 troposphere and all that. And I find it's 21 really complicated. 22 You know, I was trying to look at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 425 1 that figure and try to figure out a couple of 2 simple things, which is, you know, the VOC, 3 you know, potentiation of formation of NO2, 4 sort of a big issue, and ozone quenching. 5 Well, they're kind of there. You 6 can kind of, if you really spend a lot of time 7 looking at it. But, you know, it really takes 8 a lot of digging. And this should be a figure 9 where, you know, those sorts of processes seem 10 to be pretty obvious. 11 So those are the micro things I 12 wanted to say about the Executive Summary. 13 The micro things about the Integrative 14 Summary. So the questions that Joe brought 15 up, there's that whole list of questions, both

16 for welfare and for health effects. 17 There was one, I'm stepping out of 18 my area of expertise now, but there seemed to 19 be one question missing from the policy 20 relevant questions for welfare effects, which 21 had to do with time course effects. 22 Maybe it's hidden there somewhere.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 426 1 But because this is so critical to 2 distinguishing the form and the level and the 3 averaging time of the primary versus the 4 secondary standard, it would seem to me that

5 that would be sort of a front and center 6 policy relevant question in the welfare arena. 7 So, I'll end there. 8 DR. SAMET: Kathy? 9 DR. WEATHERS: So, I'll be quick. 10 I agree with most of the comments that have 11 been made already. 12 On LXV, it seems to me this falls 13 actually on, it's various to saying, is that 14 it seems that the issue that's identified 15 there is that it's difficult to assess the 16 spatial heterogeneity. And that is not the 17 only issue with ecological systems. 18 There's a lot of temporal 19 variability and again, if this were pointed 20 out in this Preamble, it might support the 21 comment that Sverre just made about, you know, 22 there being no information about temporal

### 202-234-4433 Neal R. Gross & Co., Inc. Page 427 1 heterogeneity. 2 Humans, or biology, non-human3 biology, like human biology is very non4 linear. In the Executive Summary, my issues 5 can be synthesized, I think, by focusing on 6 the figures. 7 Again, this follows on the comment 8 that was just made. Those figures can be 9 quite powerful and integrative, but I find 10 them quite confusing, and they seem to be an 11 afterthought. 12 So, I would encourage you to keep 13 them, but to look at them very carefully and 14 decide what you want to communicate. And I 15 would encourage you to try to communicate 16 large, integrative ideas. So I find that to 17 be kind of frustrating, but an area of 18 opportunity. 19 And in the Integrative section, I 20 would agree with a comment that Helen made 21 earlier. I think that this is an opportunity 22 to beef that up. And others have made it as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 428 1 well. 2 And the section on welfare effects 3 represents much of what's in Chapter 9. And 4 to the extent that we liked what was in 5 Chapter 9, it's repeated in this section, as 6 well. And so I would also encourage you to 7 carry over any of the changes that you make in 8 Chapter 9. 9 DR. SAMET: Okay, Chris. You've 10 gotten off easy today. 11 DR. FREY: Yes. Okay, well I 12 agree with everything I've heard. Thank you. 13 No, I'll say a few things. 14 On the Preamble, which I really 15 liked, I don't have a specific suggestion, but 16 I think there could be some flow diagrams or 17 some conceptual diagrams, kind of along what 18 Kathy has been saying. 19 It seemed to me the ISA process 20 itself might have some kind of flow diagram. 21 The various steps by which scientific evidence 22 were considered seemed like it could have one.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 429 1 Maybe, the framework for causal determination 2 could have a flow diagram. 3 I think any time you have the 4 opportunity to come up with a nice diagram, it 5 really helps. So I would encourage that. 6 I already made a comment about 7 needing to say a little bit more about 8 exposure assessment in the Preamble. I think 9 exposure assessment gets pretty short shrift 10 in the Preamble as it stands now. 11 And I think linking exposure to 12 the approach for dealing with risk 13 characterization is important, because I think 14 this Preamble could establish a little bit of 15 a framework for the reader about, you know, 16 why sometimes does EPA choose a fix site area 17 wide monitor as a surrogate for exposure, 18 whereas in other cases an exposure model might 19 be used to represent personal exposures. 20 And, I mean, there are sort of 21 obvious reasons for that to us, but it might 22 not be that obvious to the reader. And that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 430 1 would certainly help. 2 I think someone already commented 3 that susceptibility and vulnerability and 4 sensitivity, these kinds of terms could be 5 defined in the Preamble. And I don't know if 6 anyone mentioned having a glossary. 7 But I'm not necessarily 8 recommending a glossary per se, because it 9 could actually be a lot of work. But at least 10 any of these key terms should be defined 11 somewhere in the Preamble. 12 Let's see, on the Preface, I 13 enjoyed that. I agree with Joe on the value 14 of the historical perspective. I realize that 15 this document, I guess, has a draft of 16 September 2011, so this might have predated 17 some of the more recent decisions. 18 I don't know, it seems like well, 19 maybe mentioning about the ozone 20 reconsideration and what became of that would 21 at least be a little part of the story that 22 goes in there.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 431 1 On the Executive Summary, I felt 2 like there's opportunity to make it shorter. 3 And I think I've strayed into some of the 4 detailed comments. I don't know if I was the 5 motivation for Vanessa's speech earlier today. 6 But on the Executive Summary, it 7 just seems to me that it should convey the 8 basic purpose, the whatever relevant context 9 there is, the methods, results and key 10 findings. And it's not the same as 11 summarizing or borrowing text from other parts

12 of the document. 13 So it's sort of like in a big 14 abstract is how I might think of it. So in my 15 comments, I won't go into details, but I 16 illustrated, I think, a lot of wordsmithing. 17 But I think in the context of the Executive 18 Summary, it's really critical that it be as 19 short as possible. 20 So I thought rather than just say 21 make it shorter, I would give some examples, 22 so I have that in my written comments. And,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 432 1 you know, I'm sure it's hard to get it down to 2 ten pages, but I would say that might be a 3 good goal. And if you get it to 14 or 12, 4 that's great. 5 But I guess, keep in mind who's 6 the audience for that, right? And it will be 7 more accessible if it's short and if it's not 8 full of too much jargon. 9 I actually agreed with a comment 10 about the figure about the ozone chemistry. 11 I mean, I like that figure, but I think it's 12 probably beyond the audience you're trying to

13 reach. 14 So if it's important to have a 15 figure like that, it probably needs to be a 16 different figure, or that figure might be

17 deleted. 18 On the Integrative Summary, you 19 know, generally I liked it. I agree with the 20 comments about making it more integrative and 21 maybe less of a summary. 22 And again, I would just throw out

### 202-234-4433 Neal R. Gross & Co., Inc. Page 433 1 a challenge that if you can figure out ways to 2 put in conceptual diagrams that tie things 3 together, that would be beneficial to the

4 reader. 5 And maybe a challenge for Chapter 6 2 is to distill a little more clearly what did 7 we learn from this ISA? What do we know now 8 that we didn't know before this document was 9 developed? And that might help focus some 10 conclusions or findings. And that's it. 11 DR. SAMET: Okay, thanks, Chris. 12 One comment on the Preamble, and you're 13 familiar with it. 14 My look at it as a potential model 15 is the Preamble to the IARC monographs. 16 Which, of course, actually a lot of work goes 17 into that Preamble and it is peer reviewed and 18 published. And I think IARC is probably 19 updated, maybe over ten years on, perhaps 20 somebody knows. 21 But it is, I think, a useful 22 model. And it's the same in every monograph.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 434 1 So you can look at it. You had a figure in 2 the PMISA on the whole process, or there's 3 several figures. Those seem to have been lost

4 here. 5 And I think they would go back to, 6 maybe it was Chris who called for such a 7 figure. But you had to actually develop some 8 very useful figures describing how this set of 9 documents figures into decision making. So it 10 would be useful to think about doing those. 11 Just a couple of other comments. 12 The Executive Summary, so that's really 13 intended, if I understand where you've gone 14 with it, to be a general public summary. 15 And maybe it should be labeled as 16 such, and not called an Executive Summary. I 17 mean, so there's no that there's no ambiguity 18 about who it is, it's for everybody. 19 And so maybe the name should 20 change, which would leave you with the 21 question of whether you do need an Executive 22 Summary. Right now your so-called integrative

### 202-234-4433 Neal R. Gross & Co., Inc. Page 435 1 health effects is falling a little more into 2 the realm of that kind of document than not. 3 So I think, you know, again, and I 4 think there's a role for having the 5 integration. So I think you have to decide, 6 but I think to have the general public summary 7 is important and useful. 8 And then after that, to have a 9 true Integrative Summary, I think would be the 10 ideal, and perhaps you should shoot for. But 11 again, it might be useful to hear from others 12 about what you think ought to be here.

13 And one last comment on the 14 threshold issue, because I think it's 15 important. And maybe this is an issue that, 16 in part, belongs in the Preamble. 17 I mean, actually the kinds of data 18 needed to determine if a threshold is or is 19 not present, I mean, generally are 20 mechanistic. And if one were to rely on 21 animal studies, or human studies, whether 22 experimental or observational, you need a lot

### 202-234-4433 Neal R. Gross & Co., Inc. Page 436 1 of data. 2 And you need some data that will 3 provide you with something relatively robust. 4 It becomes a matter of model fitting and5 slight preference as measured by AIC or R6 squared or whatever it is, from one model over

7 another. 8 That's not getting you too far. 9 So maybe that's perhaps a preamble issue as 10 well, because that's going to be so important 11 in evidence interpretation. 12 So let me ask others for thoughts 13 on this. And particularly the Executive 14 Summary, Integrative Summary. Judy? 15 DR. GRAHAM: I think if the 16 Executive Summary is intended to be an 17 executive summary, I agree with Chris, that it 18 doesn't really go after what a policy maker

19 would need. 20 If it's intended, however, to be a 21 shrink wrap of the document for the general 22 public, then I think its structure is okay.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 437 1 But I think that the text that's here needs 2 careful revision. 3 And I won't go into detail except 4 to say, like on the exposure, exposure's not 5 defined. The word high-end exposure's not 6 even mentioned. 7 There's two paragraphs on 8 exposure. One paragraph says how do you 9 measure exposure? Who cares? What is the 10 exposure? You know, what contributes to the 11 high-end? 12 So on the Integrative Summary, I 13 would say to use consistent definitions 14 throughout. But I guess, in some cases, it 15 was too brief. Like, key determinants like 16 exercise weren't mentioned. Makes a humongous 17 difference to human clinical studies. 18 You couldn't read this and know, 19 oh this study was with exercise. I'm not even 20 talking about moderate versus heavy, although 21 I would like that. Just, did they have 22 exercise?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 438 1 There's tables there. There's no 2 indication that some of these effects were 3 irreversible. Some of the animal studies 4 showed irreversible lung structural changes. 5 That's a big deal, that it's irreversible. 6 What about the impact of 7 inflammation? So I think that some of the 8 changes you make in subsequent chapters are 9 going to help these.

10 DR. SAMET: Sure. Ted? 11 DR. RUSSELL: I'm not sure if this 12 is more a comment of the Executive summary in 13 Chapter 2, or of Chapters 9 and 10, but if you 14 look at the Executive Summary and such, in 15 terms of the non-human effects, you have the 16 very specific comments in bold, a causal 17 relationship between X and Y exists or likely

18 causal. 19 You don't actually see that in the 20 chapters themselves. It's not so succinctly 21 put. I mean it works out much better, I 22 think, if you do have those specific

### 202-234-4433 Neal R. Gross & Co., Inc. Page 439 1 statements in the chapters. 2 And in part, I think this would, 3 you know, I was reading through Chapter 10, 4 and you make the statement, "Reduction of 5 tropospheric ozone concentrations could 6 therefore provide an important means to slow 7 climate change." 8 But in the Chapter 2, in the 9 Executive Summary, you have, "It is likely to 10 be causal relationship." And where did the 11 two come together, is that if it's important 12 I think it would be a causal relationship. 13 So I think in some ways, those two 14 have to come together. And so, I think 15 everything in terms of the welfare benefits, 16 that's missed.

17 DR. SAMET: Fred? 18 DR. MILLER: I would like to go to 19 2-22, the Figure 2-3. It was shown this 20 morning. And I feel like this figure is 21 misleading, because the arrow that talks about 22 severity and goes from yellow to red has the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 440 1 entire bottom of the pyramid as yellow. 2 And to me, when you get to the 3 left hand side and you're talking about 4 altered developmentive respiratory tract and 5 altered morphology, that should have some 6 shade of red. So I personally feel that this 7 particular figure is misleading. 8 I thought there were earlier 9 discussions about questioning the extent to 10 which there really is evidence for this new

11 onset asthma. 12 And so, again, as you do and 13 incorporate the comments and revisions, this 14 figure might change in terms of some of the 15 things. But I clearly don't see where the 16 bottom row is all yellow. 17 DR. BRAIN: Nor do they all lead 18 to asthma exacerbations. You would sort of 19 look like these are all components of the next 20 layer, which is asthma exacerbations. And

21 four on the left seem to not connect. 22 DR. MILLER: So maybe some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 441 1 reworking is needed there. But I like the 2 idea of it. Don't get me wrong. 3 DR. SAMET: Okay, other comments? 4 DR. SUH: I actually didn't like 5 that figure at all. I didn't even really like 6 the idea so much. You know, I guess I think 7 a figure should be just you look at it, it's 8 clear. You know, you get a picture of what it 9 is. 10 I mean, I like the idea of 11 something like this. But I think this, itself 12 is, I'm trying to be too much. And I think a 13 figure would be great. 14 But, you know, I don't know what 15 that figure is. Sorry, I'm sorry. That's 16 very not helpful. Not helpful, not 17 constructive. But I guess I would just scrap 18 the figure and try again, as unconstructive as 19 that comment is. 20 But I guess I find it so busy that 21 you don't even know what's important in that 22 figure. So I think if the figure doesn't

### 202-234-4433 Neal R. Gross & Co., Inc. Page 442 1 convey what's important, you know, from the 2 get-go then you just need to start over. 3 DR. BRAIN: And then maybe you can 4 tell us, I'm confused as Sverre was for the, 5 you know, table that he pointed out in Chapter 6 1. And then in Chapter 2, if you look at page 7 237, you know, Table 2-2. 8 The first column is clear, 9 vegetation, ecosystem effects. And then the 10 middle one is conclusions from the previous 11 document, and then conclusions from the

12 current one. 13 So I mean, it doesn't really make 14 sense to me because, I mean, you would think 15 you would sort of look at the data, the 16 evidence in the middle and that would lead to 17 something on the right. 18 But, you know, it doesn't tell you 19 what the rating was in 2006, nor does it tell 20 you the basis for the 2011. So I just find 21 that -- am I missing something? 22 DR. SAMET: You might be. I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 443 1 think, Joe, these are the conclusions. I 2 mean, there was not a similar scale of 3 language. 4 DR. VANDENBERG: We didn't have 5 the same framework at that time. So that's 6 why the language doesn't line up very well. 7 DR. BRAIN: But I guess, then the 8 question is, would you have the same 9 conclusions for causal relationships based on

10 the 2006 data? 11 DR. VANDENBERG: We're just trying 12 to reflect what was in that document at that 13 time. 14 DR. BRAIN: Well, then, I mean, so 15 are they the conclusions based on the 2006

16 data?

17 DR. VANDENBERG: Yes. 18 DR. BRAIN: Oh, but then you would 19 like to know, did any of them change with the 20 additional data in this document? 21 DR. VANDENBERG: Right. Yes. 22 DR. BRAIN: I'm finding myself

### 202-234-4433 Neal R. Gross & Co., Inc. Page 444 1 very confused by it.

2 FEMALE PARTICIPANT: It's the same 3 thing for the human. 4 DR. BRAIN: Right, yes, it's the 5 same thing for the human, I think, which then 6 was the, you know, the concern that Sverre

7 had. 8 How could it on the one hand say 9 that, you know, evidence regarding chronic and 10 neural behavioral effects was not available. 11 And then you look over to the right and it 12 says suggestive of a causal relationship. I 13 mean, that just doesn't make sense. 14 DR. SAMET: Well, I actually think 15 the table is useful. Maybe it needs to be 16 better explained or formatted or something, 17 because I think they're really just trying to 18 show how bottom lines have changed, or not 19 changed, and that there was a descriptor that 20 was not standardized in the earlier reviews, 21 and now there is one. 22 And in some cases, you might be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 445 1 able to say that they align or don't align. 2 In some cases you have apples in one column 3 and oranges in the other, which probably leads 4 to some of the confusion. 5 But I think the tables are useful 6 to show how bottom lines have changed. 7 DR. BRAIN: But as a summary, I 8 would like to know conclusions from this 9 review. You know, what are the conclusions, 10 a narrative statement. And then how does that 11 translate into, you know, one of these 12 ratings? 13 DR. SAMET: Yes, do you have any 14 other comment on this, John?

15 DR. BRAIN: No. 16 DR. SAMET: Okay, so other 17 comments on this front matter. Yes, Daniel? 18 DR. JACOB: Well, there were some 19 comments made about the Figure 2.1 being too 20 complicated. I think I can provide something 21 better. I'll submit it.

22 DR. SAMET: I'm sure that would be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 446 1 welcomed. Okay, anything else? I'm sensing 2 a certain lull here, and I think we've done 3 our job. So let me make some comments, just 4 the reminders about things, and some things I 5 want you to think about tonight. 6 So, remember the lead person has 7 the job of essentially drafting what will go 8 into our letter to the administrator in 9 response to the charge question. 10 So you have written comments, I 11 think, in most instances from all of your 12 colleagues. We've had discussion here, I 13 think there's been some new things that have 14 come up in the discussion that should be 15 reflected in your written comments. And 16 tomorrow we'll go through those. 17 I think, also, we want to 18 highlight, think about what is the most 19 important findings that should be brought 20 forward into the letter, the body of the 21 letter itself to the administrator. And that 22 will really form the framework for our

### 202-234-4433 Neal R. Gross & Co., Inc. Page 447 1 discussion tomorrow. 2 I think a couple of other things 3 that have come up. I mean there's been some 4 mention about whether the extent of the 5 changes we are requesting is sufficient enough 6 that it might be appropriate for us to see an 7 additional draft, meet and discuss that draft. 8 I think we'll leave any judgment 9 on that until tomorrow when we go through the 10 comments and look at what changes we are 11 requesting. But that would be something for 12 everyone to think about tonight. It might 13 slow, John, the optimistic schedule a bit. 14 DR. VANDENBERG: Cautiously 15 optimistic. 16 DR. SAMET: Your cautiously 17 optimistic schedule. So, I mean, I think this 18 is something that we should just not decide 19 now, but look at tomorrow after we've gone 20 back through, circled back through the

21 comments. 22 I was reminded, Vanessa, was there

### 202-234-4433 Neal R. Gross & Co., Inc. Page 448 1 was some discussion about the handling of the 2 individual comments? And can we go back and 3 just revisit that for a moment? 4 DR. VU: So as you recall, the 5 report to the administrator has a short letter 6 that highlights the key recommendations and 7 findings from this body. And then you have, 8 appendant to the letter you have a consensus 9 or the group response to the individual charge 10 question. It has more detail in it. 11 And I think you don't plan to 12 discuss it tomorrow, but the lead also have to 13 provide that written response so that Aaron 14 will be collate all the responses together in 15 addition to the letter to the administrator. 16 And as always, the individual comments will be 17 appended to the report. 18 So I just want to make sure there 19 are three pieces to the report. So is that 20 clear, Jon?

21 DR. SAMET: Yes. 22 DR. MILLER: I have a question for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 449 1 the DFO. Has anyone from the public requested 2 time tomorrow? 3 MR. YEOW: Yes, we have one 4 request for tomorrow morning, so far. 5 MALE PARTICIPANT: I would like 6 some time. 7 DR. SAMET: Okay, if anyone who 8 does would see Aaron afterwards. Let's see, 9 Michelle? 10 DR. BELL: I just want to ask 11 Vanessa, I'm not clear on the three different 12 things that we are providing. So we have our 13 individual comments, we've already said. 14 We'll have the, you know, short 15 parts that will go into the letter. And then 16 I wasn't understanding the other one, because 17 it's going to be hard to aggregate the 18 individual comments. It's just going to look 19 like an appendix. 20 DR. VU: And Michelle, we're not 21 looking for you to do that by tomorrow. 22 That's after the meeting.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 450 1 DR. BELL: Can you tell me more 2 about what that is? I mean, I'm just, it's 3 all on different topics. I feel like it will 4 just be cutting and pasting. 5 DR. VU: Yes, Aaron's going to 6 give you, or I'll send you an email, what the 7 panel's comments on the last first draft ISA. 8 So that will be helpful. 9 But with regards to the individual 10 comments, you're welcome to revise your 11 preliminary comments which is part of the 12 final letter to the administrator. 13 DR. SAMET: But actually, 14 Michelle, I mean, yes, it's fairly 15 straightforward what you need to do, which is 16 to provide the answer to, in your case, the 17 charge question related to Chapters 6 and 7. 18 That can be based on your own 19 response, adding in the additional comments 20 and coverage from those others. I think, in 21 your case, you have four other people to look 22 at their responses. Bring it into one total

### 202-234-4433 Neal R. Gross & Co., Inc. Page 451 1 integrated response. 2 And, you know, to the extent that 3 there were new things that came up in the 4 discussion that are not reflected in those, 5 then add those in. 6 And again, these should not be 7 particularly lengthy. I mean, I think I would 8 just make that comment. They really should be 9 to the point.

10 MALE PARTICIPANT: The ones for

11 tomorrow. 12 DR. SAMET: Well, the ones for

13 tomorrow. 14 DR. MILLER: Right, and then, 15 Michelle, maybe of the ones that you do for 16 the response to the charge, maybe there's two 17 of them that should be highlighted in the

18 letter. 19 DR. SAMET: Exactly.

20 DR. BELL: I understand the

21 letter. I wasn't sure about the other one. If 22 I could get more guidance, I can wait. DR.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 452 1 SAMET: Right, and we'll send you the last 2 letters for you to look at. So that you have 3 a little guidance on --

4 DR. BELL: I understand the

5 letter.

6 DR. SAMET: What we call the 7 letter is three parts. The letter to the 8 administrator, the consensus response to the 9 charge questions and then your individual

10 comments. 11 So when I send that out to you, 12 you'll see the consensus response to the 13 charge questions, you'll know, you know, how 14 long they should be, how detailed they should

15 be. 16 But it doesn't need to be, you 17 know, it's something that you should develop 18 as the consensus for your sub-group. So you 19 don't have to copy and paste all the 20 individual comments into there. 21 It's, you know, based on what 22 you've read, what you've heard during the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 453 1 discussions today as the consensus for your 2 sub-group. 3 DR. SAMET: And just as a 4 reminder, we have tried to keep the letter to 5 the administrator itself relatively brief. 6 And then build off the response to the

7 comments. 8 And this is where we really want 9 to get to, truly the most important things 10 that, in this case we think are on target and 11 let's say what remains to be revised. Daniel? 12 DR. JACOB: So what do you want by

13 tomorrow? 14 DR. SAMET: Oh, everything. No, 15 actually by tomorrow, I mean, I think probably 16 you could have certainly, the minimum is the 17 bullets that would say, here's the main points 18 in answer to the charge questions that you 19 have. For example, the first one that you 20 took on, the Chapter 3. 21 So the bullets that would be your 22 most important points. I don't think this is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 454 1 not such a big task that you might not have 2 the whole thing actually done. 3 Remember, this probably should be, 4 I don't know, three paragraphs, four 5 paragraphs, but not long. You know, it should 6 really be focused and to the point, and 7 something that will be useful guidance to the 8 agency. 9 DR. JACOB: Forgive me. Okay, so 10 then we have the individual comments, which 11 can be very long and also bring up a lot of 12 important points. You know, so will these be, 13 then, provided for consideration? 14 DR. SAMET: They're there. Oh 15 yes, that was what Vanessa was saying. Those 16 are part of what is turned in. 17 DR. JACOB: But these, then don't 18 have to be integrated for individual chapters. 19 They can just be the individual comments? 20 DR. SAMET: Your individual 21 comments go in with your name right beside

22 them.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 455 1 DR. JACOB: Okay. 2 DR. VU: I think it will be 3 helpful after you look at what Aaron sent you. 4 It could just refresh your memory. But I 5 think what Jon is looking for tomorrow is what 6 are the key point you want to highlight. 7 You heard a lot of discussion 8 today, but you want to crystallize, synthesize 9 the key point. And you will have opportunity 10 to provide a written response for the 11 individual charge questions. 12 Aaron then pull the report 13 together. Aaron will schedule another public 14 teleconference call for you all to go through 15 the draft letter, the draft response, and 16 appendant your individual comments. 17 So you will have more opportunity 18 for you to look at to make sure you are 19 comfortable with the letter to the 20 administrator and the attachments. 21 DR. SAMET: Yes, Joe? 22 DR. BRAIN: I would just echo what

### 202-234-4433 Neal R. Gross & Co., Inc. Page 456 1 you said at the beginning of our meeting, that 2 we need not be confined to the charge 3 questions. And so if we've, you know, 4 uncovered some other big issues, I think and 5 historically, Jon correct me, but once in a 6 while, they find their way to the letter to 7 the administrator. 8 For example, I can imagine us 9 saying we really like the idea of freestanding 10 core documents that would apply to all, you 11 know, future reviews of criteria documents. 12 So that would be an example of something that 13 we might want to put in the one or two page 14 letter to the administrator. 15 And then there are other things, 16 again, that you may put in your own personal 17 comments. So again, I think that's another, 18 am I right? That's another thing that you 19 would encourage --

20 DR. SAMET: Yes. 21 DR. BRAIN: -- is things that are 22 not in the charge questions, but you think

### 202-234-4433 Neal R. Gross & Co., Inc. Page 457 1 they are important. 2 DR. SAMET: More overarching. And 3 actually, I'm just going back from my notes 4 from this morning when we had the discussion 5 of the charge, the adaptation. There are a 6 couple of issues that came up. 7 The adaptation, attenuation issue 8 which may be one that goes back to, say that 9 needs more consideration. And then this point 10 that has come up again. I think, Fred, Judy 11 I think probably particularly championed this 12 idea of the physiological indicator of FEB1 13 versus other processes that are initiated by 14 exposure and sorting this out. 15 So those were both sort of things 16 we talked about this morning as important and 17 still are. Okay, so the other would be after 18 you sort of at least get your bullets 19 together, if you could email those to Aaron. 20 He's asked that you email them by 21 roughly nine, because what he'll do is he will 22 compile them and send them back out to us. So

### 202-234-4433 Neal R. Gross & Co., Inc. Page 458 1 you can take a look before morning. 2 Let's see, and we reconvene at 3 8:30 tomorrow. We end at 11:30, I think many 4 of us probably have flight schedules based 5 around an 11:30 finishing time. So let's aim 6 for it. 7 Probably some of you have flight 8 schedules aimed around a 10:00 finishing time. 9 But wishful thinking. But I think we will 10 need the three hours to get through our job. 11 So let's see, if there's nothing else, let me 12 turn it over to Aaron for last words here. 13 MR. YEOW: Right. So again, just 14 a reminder to the public, if you want to make 15 a clarifying remark for tomorrow's session, 16 please come see me and let me know. And limit 17 that to one minute and it's just for 18 clarifying remarks for the panel to consider. 19 I think that's all we have. Did 20 you have a question, Fred?

21 DR. MILLER: Can we leave our 22 written material here, so we have it on a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 459 1 computer disk? Or is this going to be locked, 2 or do we need to take everything with us? 3 DR. VU: You can leave everything 4 here except your laptop. 5 MR. YEOW: Yes, you can leave your 6 written materials here. I wouldn't leave 7 anything valuable, though. 8 DR. SAMET: Okay, well.

9 MR. YEOW: You know what I meant. 10 I guess I have to do something. Yes, you got 11 off easy. 12 (Whereupon, the foregoing matter 13 was concluded at 5:10 p.m.)

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96:19 misleading 75:21

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202:15 297:14 missed 225:16,17

264:2,3 265:17 394:3 439:16 misses 403:6 missing 56:17

247:22 264:10 324:9 376:11 417:18 421:11 425:19 442:21 misused 75:22 mitigated 67:8 144:3 mix 233:21 399:6 mixing 187:13,20 190:15 192:7 240:15 279:7 mixture 134:13

375:17 MOA 287:18 288:5

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289:1,6 296:10,13 324:17 437:20 modes 304:13

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364:14 365:1,5 368:15 369:1 386:4,7 modified 107:2

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369:19 380:1 modifiers 368:1,10

370:11 371:12,17 371:20 385:20 modifies 351:15 modify 368:11

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396:20 molecule 51:10

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234:22 382:4,8,13 387:4 monthly 91:1 92:9

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81:13 95:13 99:5 110:22 112:19 114:4 124:2 164:15 170:3,20 173:3 180:7,10,14 180:15 181:18 182:7 185:6 218:7 346:21,22 NAB 240:1 NABO 228:11,13 nails 350:2 naive 211:20 name 140:7 413:7

434:19 454:21 Nancy 199:12,12

395:4 nanometers 278:4 narrative445:10 narrow 110:22 374:13 narrowly 374:14 nasal 281:18 282:6

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327:12 neglect408:15 neglected 208:19 negotiating 182:5 Neiding 381:9 neither 139:6 neonates 122:16

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87:15 116:11 125:13,17 140:2 141:1,15 185:12 204:19 208:1 211:1 periodic419:4 periods 48:15 106:5 permanently 75:15 person 10:20

296:14 374:3 394:9 446:6 personal 105:22 106:2,13,17 111:22 112:4 260:21 309:1 429:19 456:16 personally 100:12 110:15 230:12 272:1 274:19 306:19 308:5 314:6 357:20 440:6 perspective 191:6

238:7 246:2 255:17 331:20 361:22 389:8 413:9 424:3 430:14 perspectives

402:18 pertinent 122:6 135:16 249:5 pet286:17 Peter 387:17 Petroleum 147:9 phase 67:19 223:3 phenomenon 212:9

365:6 phenotype 378:7 Philadelphia 53:22 phone 8:10 10:21 14:11,12,15 40:13 87:21 88:9 103:17 103:21 116:6 117:2 308:8,9 photochemical 9:4 photosynthesis

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281:9 tracheobronchial

281:12 track 279:1 tract75:10 280:21

440:4 trail 246:19 trajectories 187:22 transcriptomic

396:14 transfer406:16,21

408:9 transient 172:21 translate 75:15

85:8 445:11 transparent 104:14 transport25:19 143:11 159:12 183:18 184:2,5 189:9,17 195:7,13 219:12 237:7 transported 275:2 Travis 2:19 41:15 treadmill 138:18 treat 143:5 146:11

221:19,21 treated 219:13

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353:15 354:6,9 triangular 31:21

323:20 335:22 336:14 337:1,5,11 tried 23:13 24:8

27:7 29:1 30:13 30:19 32:7 33:16 363:3 453:4 trigeminal 339:13 trigger 296:6 Trinidad 187:3,9

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291:1 tying 158:21 type 35:4 53:3,15

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270:20 ultimately 18:20

251:15 Ultman 2:8 13:2,2

76:3 138:2,20 271:5,8 282:2,3 293:18 umbrella 374:15 umpteen 61:4 unable 11:3 unachievable 63:12

67:9 UNC 147:12 uncertain 159:16 159:19 220:1 408:7,8 uncertainties 105:20 113:20,22 140:11 142:15 144:18 146:4 158:14 159:4 160:5 184:6 221:19 294:8 uncertainty 55:16

55:19 56:12 105:17 142:1 171:17 184:10 407:10 Uncle 387:5 uncluttered 417:6 unconstructive 441:18 uncontrollable

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233:20 uncovered456:4 uncritical 219:14 undefined 179:8 underestimate 191:13 198:14 underestimated 160:9 underestimates 199:1 underestimating 176:14 underestimation

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4:22 11:17 12:10 12:13,16,19 13:3 13:5,10,13,16,19 14:6 127:9 147:3 147:7 186:3 200:8 200:14 unmanageable

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270:12,13 396:11 validate 242:13 validation 126:10 186:20 validity 100:4 Valley 231:18 valuable 9:14 39:6

213:22 237:15 416:11 459:7 value 50:21 153:5 185:19 187:15 203:3 227:15 228:20 229:8 230:4 240:2 293:10 430:13 values 47:4 52:9

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3:9 10:1 14:20 16:19 35:1,14,17 36:17 39:19 225:12 250:15 258:6 303:15 359:19 415:1,15 416:3 422:15 443:4,11,17,21 447:14 Vanessa 2:13 3:4

8:13,17 11:11,18 15:18 16:21 116:18 229:21 235:12 447:22 449:11 454:15 Vanessa's 431:5 variability 108:16 139:3,7 141:4 165:12 172:19 202:22 203:2 207:5 218:14 222:10 239:4 262:19 280:1 283:9,13 372:4,7 426:19 variable 31:20 128:9 156:10 variables 104:21 139:6 157:18 variation 91:3

262:16 295:2,4 397:21 398:3 variations 108:8

365:4 varieties 221:8 variety 21:15 184:17 285:21 395:12 405:13 various 74:16

222:7 257:5 273:11,12 275:9 276:2 294:5,17 295:9,13,17 395:18 420:14 426:13 428:21 vascular 377:15 vastly 271:18 Vedal 2:8 12:12,12

58:13 81:17 128:18 129:18,22 152:20 155:8 320:12 341:22 342:16 352:13 353:2,5 360:1 419:15 421:5,22 422:11,21 423:3,6 vegetation 5:10

33:9,11 203:17,20 204:5 389:19 399:13 442:9 vehicles 233:2

234:1 ventilation 125:1 125:12 131:22 288:15 298:7 323:15 verge 220:13 version 34:21

221:12 247:17 266:2,3 306:17,19 318:1 326:14 402:20 versions 140:16,18 versus 65:6 72:15 130:6 176:11 177:6 204:9 209:9 251:9 253:9 261:14 297:16 307:11 314:10 320:14 323:1,20 346:15 353:15 354:9 379:8 382:7 383:14 391:9 426:3 437:20 457:13 vertical 142:21 143:3,11 144:5 145:17 192:5 vertically 144:16 veteran 255:22 veterans 102:9 VI 66:19 video 387:1 view 19:5 115:6 149:9 168:7,10,11 213:4 244:4 251:7 252:4 258:17 310:22 342:14 344:3 346:5 360:7 419:12,16 viewpoint270:12 views 167:16 168:4 186:10 201:1 359:21 361:8,17 376:19

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333:14,17 366:18 410:19 volunteers 134:21 Von 381:9 Vu 2:13 3:4 8:13,16

8:17 116:20 118:1 448:4 449:20 450:5 455:2 459:3 vulnerability 21:14

365:21 366:10 385:2 411:5 430:3 vulnerable 54:20 W wading 64:9 wait57:3 451:22 waiting 387:9,10 walking 289:2 want 8:2,9 11:3 16:10 28:12 41:4 41:19 45:7 48:21 52:15 74:2 85:4 85:18 88:17 91:12 94:9 101:1,14 103:12 111:6 115:20 123:10,12 137:7,15 142:2 145:19 151:12 208:1,14 221:6 226:7 227:11 228:10 229:2,2,22 236:19 243:2 248:1 250:14 255:20 267:12 274:10 285:7,8 297:15 301:3,14 303:19 307:16 310:6,16 311:13 312:2 313:9,16 316:5 317:4,8,19 333:16 334:1 336:8 337:19 340:3 341:14,19 349:9 353:13 355:3,14,17,19 356:17 378:6 379:15 380:8 382:21 386:4 389:22 391:21 392:10 393:20,21 394:10 396:21 399:22 406:13 408:16 417:3,17 424:4,14 427:14 446:5,17 448:18 449:10 453:8,12 455:6,8 456:13 458:14 wanted 14:8 32:21

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400:5,7 Watkinson 339:4 wave 31:14 323:20

323:21 336:13,22 337:5,11,11 353:15 354:5,9 way 19:13 73:1

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This is to certify that the foregoing transcript

In the matter of:

Before:

Date:

Place:

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

----------------------- Court Reporter 521

Ozone Review Panel

US EPA

01-09-12

Durham, NC