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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 + + + + +

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 OZONE REVIEW PANEL

 + + + + + 

 PUBLIC MEETING

 + + + + +

 THURSDAY, MAY 19, 2011

 + + + + +

 The meeting convened, in the

Chancellor's Ballroom of the Carolina Inn, 211

Pittsboro Street, Chapel Hill, North Carolina,

at 8:30 a.m., Jonathan Samet, CASAC Chair,

presiding.

CASAC MEMBERS PRESENT:

JONATHAN M. SAMET, CHAIR

GEORGE A. ALLEN

JOSEPH D. BRAIN 

H. CHRISTOPHER FREY*

ARMISTEAD (TED) RUSSELL

HELEN SUH 

KATHLEEN WEATHERS*

PANEL MEMBERS PRESENT:

ED AVOL

JOHN BAILAR

MICHELLE BELL

DAVID CHOCK

WILLIAM MICHAEL FOSTER 

JUDITH GRAHAM

DAVID GRANTZ

JACK HARKEMA
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DANIEL JACOB

STEVEN KLEEBERGER 

FREDERICK J. MILLER

HOWARD NEUFELD

JAMES ULTMAN

SVERRE VEDAL*

PETER WOODBURY

SCIENCE ADVISORY BOARD STAFF:

HOLLY STALLWORTH, DESIGNATED FEDERAL OFFICER

*Participating via telephone
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 C-O-N-T-E-N-T-S

Call to order 8

 Dr. Holly Stallworth

 Designated Federal Officer

 SAB Staff Office

Introduction of Panel Members 11

Review of Agenda 14

 Dr. Jonathan Samet

 CASAC Chair

Presentation on the Ozone Integrated 18

Science Assessment (ISA)

 Dr. John Vandenberg 18

 Ms. Lydia Wegman 22

 Questions and Comments 29

 Dr. Jim Brown 37

 Questions and Comments 50

 Ms. Debra Walsh 52

 Questions and Comments 61

Public Comments 66

 Dr. Allen S. Lefohn 67

 ASL Associates

 Helen, Montana

 Questions and Comments 73
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 C-O-N-T-E-N-T-S (CONTINUED)

Public Comments (Continued)

 Dr. Julie Goodman 78

 Gradient Corporation

 Cambridge, Massachusetts

 Representing the American Petroleum

 Institute

 Questions and Comments 86

 Mr. George Wolff 89

 Air Improvement Resource, Inc.

 Representing the Utility Air

 Regulatory Group

 Ms. Sam Oltmans 99

 Boulder, Colorado

Discussion of Charge Questions 102

 Framework for Causal Determination 103

 (Question 2)

 Dr. John Bailar 103

 Dr. Sverre Vedal 107

 Dr. Howard Neufeld 114

 Dr. Jonathan M. Samet 116

 Discussion 118
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 C-O-N-T-E-N-T-S (CONTINUED)

 Atmospheric Chemistry and 127

 Ambient Concentrations

 Question 4

 Dr. Ted Russell 127

 Mr. George Allen 132

 Dr. Daniel Jacob 144

 Discussion 155

 Environmental Effects 166

 Question 10

 Dr. Kathleen Weathers 166

 Dr. David Grantz 168

 Dr. Howard Neufeld 176

 Discussion 182

 Climate Change and UV-B Effects 198

 Question 11

 Dr. Howard Neufeld 198

 Dr. Peter Woodbury 199

 Dr. Daniel Jacob 203
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 C-O-N-T-E-N-T-S (CONTINUED)

 Exposure 210

 Question 5

 Mr. Ed Avol 210

 Dr. Chris Frey 215

 Dr. David Chock 218

 Discussion 221

 Dosimetry and Mode of Action 237

 Question 6

 Dr. Fred Miller 237

 Dr. Joseph Brain 251

 Dr. Jack Harkema 256

 Dr. James Ultman 264

 Discussion 274

 Health Effects of Short-Term 283

 Exposure (Question 7)

 Dr. W. Michael Foster 283

 Dr. James Ultman 287

 Dr. John Bailar 293

 Dr. Judith Graham 296

 Discussion 306
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 C-O-N-T-E-N-T-S (CONTINUED)

 Health Effects of Long-Term 319

 Exposure (Question 8)

 Dr. Michelle Bell 319

 Dr. John Bailar 229

 Dr. Judith Graham 331

 Discussion 336

 Susceptible Populations 343

 (Question 9)

 Dr. Steven Kleeberger 343

 Dr. Fred Miller 348

 Discussion 352

 Integrative Summary 372

 (Question 3)

 Dr. Helen Suh 372

 Dr. Christopher Frey 380

 Dr. Howard Neufeld 382

 Discussion 386

 Length of Document 407

 (Question 1)

 Dr. Judith Graham 407

 Dr. Michelle Bell 411

 Discussion 418

Administrative Matters 424
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:30 a.m.

3 DR. STALLWORTH: Good morning.

4 I would like to go ahead and get

5 started.

6 I want to thank everyone for

7 coming.

8 I am Holly Stallworth.

9 How is the audio here?

10 I am the Designated Federal

11 Officer for the Clean Air Scientific Advisory

12 Committee. And as always, I need to open the

13 meeting with a short statement.

14 CASAC is a federal advisory

15 committee, and by EPA policy, its meetings and

16 deliberations are held as public meetings that

17 meet the requirements of the Federal Advisory

18 Committee Act.

19 CASAC is chartered by law to

20 provide advice to the Administrator.

21 Consistent with the requirements

22 of FACA and with EPA policy, the deliberations
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1 are CASAC are conducted in public at meetings

2 for which advanced public notice is given. 

3 The discussions and substantive deliberations

4 of the panel, its interactions with the public

5 and the agency are conducted in sessions where

6 I, as the Designated Federal Officer, am

7 present to ensure that the requirements of

8 FACA are met. And this includes the

9 requirements for open meetings, for

10 maintaining records of deliberations, for

11 making available public summaries of meetings,

12 and providing opportunities for public

13 comment.

14 I will be checking the minutes of

15 the meeting to summarize the discussion and

16 action items. These minutes will be certified

17 by our Panel Chair, Dr. Samet, once completed,

18 and posted on our website.

19 Finally, I would like to comment

20 on the status of this Committee's compliance

21 with federal ethics laws. The SAB Staff

22 Office has reviewed information relevant to
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1 conflict of interest and appearance of a lack

2 of partiality, and appropriate balance and

3 breadth of expertise, knowledge, and

4 experience needed to address the charge, and

5 determined there are no conflict-of-interest

6 or appearance of lack-of-partiality issues for

7 any of the members participating.

8 Before I turn the meeting over to

9 Dr. Samet, I want to see if there is anybody

10 on the phone.

11 At some point, Sverre Vedal should

12 be calling in as well.

13 Chris Frey had the flu. He was

14 unsure if he would --

15 DR. FREY: Holly, this is Chris

16 Frey. I'm on the phone.

17 DR. STALLWORTH: Oh, great. Good,

18 good, good.

19 I think I am forgetting something. 

20 Oh, my Director, Dr. Vanessa Vu, is unable to

21 be here today. She sends her regrets.

22 I am going to turn the meeting
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1 over to Dr. Samet.

2 DR. SAMET: Okay. Good morning. 

3 Good morning, everyone, and welcome, I guess,

4 to what will be the first of multiple meetings

5 of this panel. So, we will have the

6 opportunity to spend a lot of time together,

7 I suspect, in North Carolina reviewing

8 documents over the cycle of this.

9 Let me start. First, I will ask

10 the panel to introduce themselves, and, then,

11 we will come back to the agenda.

12 So, again, I am Jon Samet, Chair

13 of CASAC, pulmonary physician and

14 epidemiologist from the University of Southern

15 California.

16 DR. GRAHAM: Judy Graham,

17 independent consultant, with a background in

18 inhalation toxicology and exposure.

19 DR. MILLER: Fred Miller,

20 independent consultant; background dosimetry,

21 inhalation toxicology, extrapolation modeling.

22 DR. GRANTZ: David Grantz. I am a
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1 plant physiologist from the University of

2 California at Riverside.

3 DR. HARKEMA: I'm Jack Harkema

4 from Michigan State University, a pathologist

5 and inhalation toxicologist.

6 DR. JACOB: I am Daniel Jacob,

7 atmospheric chemist at Harvard University.

8 DR. KLEEBERGER: Steve Kleeberger

9 from the Laboratory of Respiratory Biology at

10 NIEHS. My background is in environmental

11 physiology and genetics of susceptibility to

12 air pollutants.

13 DR. NEUFELD: I'm Howard Neufeld

14 from Appalachia State University, and I am a

15 plant ecophysiologist.

16 DR. RUSSELL: Ted Russell at

17 Georgia Tech. I am an environmental engineer.

18 DR. SUH: Helen Suh from NORC at

19 the University of Chicago. I am an exposure

20 assessment, environmental health scientist.

21 DR. ULTMAN: Jim Ultman, Penn

22 State University. I am a biomedical engineer.
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1 DR. WOODBURY: Peter Woodbury from

2 Cornell University. I do ecosystem modeling,

3 agriculture and forestry.

4 MR. ALLEN: George Allen from

5 NESCAUM in Boston. Measurement methods,

6 monitoring, exposure assessment.

7 MR. AVOL: Ed Avol, University of

8 Southern California. Exposure assessment and

9 health effects research.

10 DR. BAILAR: John Bailar, retired

11 from the University of Chicago, and now

12 scholar-in-residence at the National

13 Academies. I am a physician, a statistician,

14 and epidemiologist.

15 DR. BELL: Hi. I'm Michelle Bell

16 from Yale University at the Environment

17 School, with joint appointments at the School

18 of Public Health and, also, the Environmental

19 Engineering Program. And I do epidemiology of

20 air pollution and human health.

21 DR. BRAIN: Joe Brain in Boston at

22 the Harvard School of Public Health. I am a
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1 lung biologist and inhalation toxicologist.

2 DR. CHOCK: David Chock,

3 independent consultant, environmental

4 scientist.

5 DR. FOSTER: Mike Foster,

6 Professor of Medicine at Duke University

7 Medical Center. Expertise in pulmonary

8 physiology.

9 DR. SAMET: Thanks. As you can

10 see, it takes a village to review the Ozone

11 ISA.

12 (Laughter.)

13 So, let's just spend a moment on

14 the agenda. Of course, we are going to begin

15 and hear about the ISA from the EPA team that

16 has put it together.

17 We will have comments from the

18 public. Then, we are going to go on and move

19 through the discussion of the charge

20 questions.

21 I want to thank everybody for the

22 work that has been done in advance and the
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1 comments that have been submitted. And we are

2 on our way towards getting the job of review

3 done.

4 Our goal in these discussions will

5 be really to go over the key points, the

6 points that really the Committee needs to

7 discuss. I think we will try to avoid more

8 minor points of discussion and wordsmithing,

9 and so on.

10 So, this is an opportunity to go

11 through the lead discussants and, then, have

12 others join in. And by the end of the day, we

13 will want to have a plan for drafting our

14 response. What are the key points that will

15 go into overall letter and, then, the charge

16 questions.

17 Again, for those of you who are

18 new to this, which is perhaps some of you,

19 what we have been doing is writing a letter to

20 the Administrator that really summarizes the

21 main overall points about the document and

22 highlights those aspects of our responses to
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1 the charge questions that we think are most

2 critical.

3 So, we have been writing, roughly,

4 a two-page, single-spaced letter, then

5 accompanied by our Committee's responses to

6 the charge questions. And, then, your

7 individual comments are appended as well.

8 So, there are three things, then. 

9 There is our summary letter to the

10 Administrator, the roughly two pages,

11 highlighting key points. There are our,

12 essentially, consensus responses to the charge

13 questions and, then, the individual responses.

14 And what we will do is, after the

15 meeting, we will complete the drafting of the

16 responses to the charge questions, we will

17 look at the letter via teleconference, and

18 come to completion of that. And so, that will

19 take probably, roughly, a month after this.

20 Now tomorrow there's the review of

21 the two scopes and methods plans for the

22 health risk and exposure assessment and the
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1 welfare risk and exposure assessment. And

2 there will be discussion of those, and that is

3 a consultation. Yes, that is a consultation. 

4 So, it does not come with charge questions,

5 and we just provide our guidance to the

6 agency.

7 So, I think that is sort of a

8 quick review. And again, for those of you who

9 have been with the process in the past, and I

10 think we will hear about this from the agency. 

11 We have now this change from what you will

12 remember from the old days of the criteria

13 document staff paper to the new ISA risk and

14 exposure assessment analysis and the policy

15 document. So, I suspect you are going to take

16 us through all of that.

17 So, I think if along the way there

18 are any questions about process, and anybody

19 wants clarification, let me know. But any

20 immediate questions or comments?

21 (No response.)

22 Okay. Good. Then, let me turn
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1 things over, I guess. John?

2 DR. VANDENBERG: I'm trying to get

3 used to the technology here.

4 My name is John Vandenberg, and I

5 would like to welcome the Committee and

6 indicate our great appreciation for the time

7 today and tomorrow, as well as for the next

8 couple of years. I think, as Dr. Samet

9 pointed out, this is a fairly elaborate and

10 extremely important process, and we greatly

11 value your input, both your comments today and

12 tomorrow as well as your written comments now

13 and subsequently. It is a great opportunity

14 for us to benefit from your perspectives.

15 I am joined this morning by Lydia

16 Wegman, who is a colleague at OAQPS, the

17 policy office in the Health and Environmental

18 Impacts Division. She will be speaking about

19 the policy aspects of risk and exposure

20 assessment, policy assessment, and,

21 importantly, about the reconsideration.

22 We think it is important that we
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1 provide some context this morning for the

2 panel to understand the different pieces that

3 are coming together here, so there is no

4 confusion. We certainly welcome any questions

5 or clarifications.

6 Jim Brown will, then, go through

7 the charge questions and very briefly

8 summarize some of the nature of the

9 information that is in the different chapters,

10 just setting up for the discussion later

11 today.

12 And, then, Debra Walsh, my

13 colleague here, will also be speaking about

14 the Health and Environmental Research Online

15 system. This is an important new development

16 that we have been bringing online over the

17 last couple of years that will continue to

18 evolve over the next several years. And we

19 want to make sure that the panel understands

20 the capabilities of that and how that will

21 help support your review steps.

22 We are also joined this morning by
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1 our staff in the back. A number of EPA staff

2 are here. I am very proud of this group of

3 people, and they are listening with great

4 interest to your comments about the various

5 chapters that they have been contributing to.

6 So, we are going to be very brief

7 on this because we think we need to get right

8 into the discussion. The various parts of the

9 process are shown here.

10 We began by having a workshop and,

11 then, we have developed an integrated review

12 plan. And the point of today's discussion is

13 really regarding the integrated science

14 assessment and, then, for tomorrow the

15 consultation on the risk and exposure

16 assessment.

17 Ultimately, these will flow

18 together with CASAC and public input -- and

19 again, we very much appreciate the public

20 comments -- flowing into the policy

21 assessment, which then goes through a series

22 of meetings and decision points, including the
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1 agency decisions on proposed standards,

2 followed by the agency decisions, again, after

3 public comment, on the final standards. And

4 that will take course, over the next couple of

5 years.

6 In terms of the integrated review

7 plan, what we have done in the last several

8 years is recognized the benefit of having a

9 coherent program plan that cuts across both

10 the science and the policy. We bring that

11 together in our integrated review plan, which

12 lays out the schedule which we will show you

13 in a moment, highlights sort of the process

14 for conducting a review of the CASAC meetings,

15 the development of key policy-relevant issues

16 that tend to be very important to how we form

17 and narrow down some of the areas of emphasis

18 in the ISA.

19 And, then, that flows into the

20 ISA, which again, is intended as a concise

21 evaluation and synthesis of the most policy22 relevant science. Our emphasis is to identify
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1 the world science and bring that to bear and

2 draw conclusions from that, as well as

3 highlighting the strengths and uncertainties

4 of the evidence. It is the foundation for the

5 risk and exposure assessment as well as the

6 policy assessment and the agency decisions.

7 Again, underscoring the sort of

8 process that we have got here, we have a

9 companion group. I will turn now to Lydia

10 Wegman to pick it up from there.

11 So, Lydia?

12 MS. WEGMAN: I want to add my

13 thanks to Jon.

14 Again, my name is Lydia Wegman. I

15 am the Director of the Health and

16 Environmental Impacts Division in the Office

17 of Air Quality Planning and Standards, which

18 is part of the Office of Air and Radiation at

19 EPA. And it is my Division that takes on

20 these next two pieces that we have up here.

21 But I just want to say thank you

22 again for all the time you have put into
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1 reviewing the documents to date. And as you

2 will see when I walk through the schedule, we

3 are really looking at about another three

4 years from to when we get to a final standard. 

5 And your work is going to be invaluable as we

6 move forward on this review and the many

7 documents that you will be reviewing and

8 providing comments on. When I go through the

9 schedule, you will see the points where we

10 anticipate your review.

11 Once the integrated science

12 assessment is done, and I shouldn't say "once

13 it's done", in concert with the development of

14 the integrated science assessment, my office

15 works on the risk and exposure assessment. 

16 Today you will be giving us comments and

17 consulting with us on the plan for the risk

18 and exposure assessment. So, that will be the

19 scope and methods document, which you have

20 already reviewed. And, then, the document

21 itself will provide a presentation of the

22 results and observations and uncertainties
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1 that will help inform the policy assessment.

2 The next document is called the

3 policy assessment. It used to be called the

4 staff paper, as John said. And the policy

5 assessment is a document that integrates the

6 science and the risk and exposure assessment

7 and provides options for the Administrator to

8 consider in setting the standard.

9 I want to emphasize here that, in

10 addition to providing us advice on science and

11 the technical assessments, we seek your advice

12 on the standards themselves. We are asking

13 for your help to integrate the science, the

14 risk and exposure assessments, to come up with

15 policy options for the Administrator to

16 consider.

17 The Administrator makes the

18 decision, but your advice on what options she

19 could consider and what options are supported

20 by the science and risk and exposure

21 assessments is critical to her review.

22 We have a recent court case
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1 involving our particulate matter standard

2 which observed that we had not followed the

3 advice of CASAC and that we had failed to

4 provide an adequate explanation for our

5 decision not to follow the advice of CASAC. 

6 So, I want to emphasize to you how important

7 your advice is to the agency in thinking about

8 these issues. It is important for the

9 Administrator's consideration, and it is

10 important from the standpoint of the Clean Air

11 Act and the courts which review our actions on

12 these rules.

13 So, let me walk through quickly

14 the schedule, as we see it. I won't go

15 through every single date.

16 But the first slide here are the

17 completed elements. It took us some time, but

18 we did actually ultimately issue a final

19 integrated review plan for this review. That

20 is the third from the bottom where it says

21 "final IRP released". It was released in

22 April, very shortly after we got out, after
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1 John and his folks got out the first draft of

2 the ISA.

3 As you know, we have got the scope

4 and methods plan.

5 Today's CASAC meeting is the first

6 of many. This shows you what we anticipate

7 for the next three years, roughly. There will

8 be a second external review draft of the ISA

9 coming in September, followed by our first

10 draft of the risk and exposure assessment,

11 which will build on the ISA, in October. 

12 Then, we hope to have a meeting with you in

13 November of this year to go over both of these

14 documents.

15 Then, the final integrated science

16 assessment in February of next year. Then,

17 our second draft of the risk and exposure

18 assessment and a first draft of the policy

19 assessment. And all of those will be -- well,

20 actually, I'm sorry, the second draft of the

21 risk and exposure assessment and the first

22 draft policy assessment will be coming in July
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1 of next year.

2 So, then, we will have the final

3 risk and exposure assessment and the second

4 draft of the policy assessment. And you will

5 be reviewing the second draft of the policy

6 assessment in December/January of 2013,

7 December 2012, January 2013.

8 The final policy assessment in

9 March of 2013, and, then, we hope to have a

10 proposed rule out by September of 2013 and a

11 final rule by June of 2014. So, that is the

12 three-year schedule as we envision it right

13 now.

14 You will note that this is not

15 following the five-year schedule precisely. 

16 We last issued an ozone standard in March of

17 2008. Normally, we would have expected to

18 conclude this review by, roughly, March of

19 2013, but the Administrator of EPA made a

20 decision to reconsider the March 2008

21 standard. And that has led to some delay in

22 our moving forward on this review.
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1 We proposed revisions to the March

2 2008 standard. The March 2008 standard, as I

3 think you all well know, was set at 0.075

4 parts per million. And in January of 2010,

5 consistent with the advice we have gotten from

6 CASAC many times, we did, in fact, propose to

7 set the standard within a range of .060 to

8 .070 parts per million.

9 And we also proposed to set a

10 distinct cumulative secondary standard within

11 the range of 7 to 15 parts per million hours. 

12 That is using the W126 form.

13 As many of you know, we sought

14 additional advice from CASAC in early 2011,

15 and we got that advice, reiterating again

16 their recommendation for .060 to .070 parts

17 per million.

18 And we have indicated to the U.S.

19 Court of Appeals for the District of Columbia

20 Circuit that we plan to issue a final rule on

21 the reconsideration by July 29th of this year. 

22 So, that is activity going on in parallel with
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1 this review. We just wanted to make sure you

2 understood the nature of the two actions.

3 So, that is it, and I will see if

4 there are any questions. Then, I will turn it

5 over to James Brown.

6 Yes, Fred?

7 DR. MILLER: Lydia, how does your

8 schedule change if Obama isn't reelected?

9 (Laughter.)

10 MS. WEGMAN: No comment, Fred.

11 DR. MILLER: I just thought we

12 should set the tone here.

13 DR. SAMET: It might be useful,

14 Lydia, for you or John maybe to describe in

15 what way these new sets of documents differ

16 from the old or are intended to review. What

17 is the difference between an ISA and a

18 criteria document?

19 MS. WEGMAN: Yes, I am going to

20 let John take that one.

21 DR. VANDENBERG: I think it was in

22 2008 we derived a new process. The idea was
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1 to move away from the encyclopedia-type air

2 quality criteria document, which I think for

3 ozone the last time was about 2,000 pages, and

4 have a more integrated and effective document.

5 Part of the key difference here is

6 that we created, as documented in Chapter 1,

7 a new framework for how we are considering

8 information in terms of deriving causality

9 determinations. And so, in the former

10 document, the air quality criteria documents,

11 you wouldn't see a consistent manner in which

12 we evaluated the evidence. We weren't as

13 clear about that.

14 So, part of what we have done in

15 the new document is present the framework and

16 the approaches that we are using to derive

17 causality evaluations in Chapter 1.

18 In Chapter 2 -- this is also a new

19 difference -- we have brought a lot of the

20 findings forward just to kind of highlight the

21 major findings that, then, are supported by

22 the subsequent chapters. And so, there has
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1 been a restructuring of the document, a change

2 in the way we have framed it in terms of the

3 framework that we are using and the derivation

4 of these causality statements.

5 And the way we are presenting the

6 results has changed quite a bit as well. We

7 are adding more tables, more figures. 

8 Importantly, again now, we are also using the

9 Health and Environmental Research Online

10 system to augment what is in the paper copy,

11 if you will.

12 So, we have a much more

13 comprehensive, but also more focused approach

14 here in the integrated science assessments. 

15 So, that is this change.

16 As Jim Brown will show in a few

17 minutes, we are also trying to highlight the

18 basis from the older studies, whether it is

19 the 2006 air quality criteria document or even

20 earlier ones, and bring some of them, the most

21 pertinent findings forward into this document,

22 to provide that larger context for the
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1 totality of the evidence that we are

2 considering in this document.

3 So, it represents, for some of you

4 who have been familiar with the old air

5 quality criteria documents, they were much

6 longer and much more, you know, study, study,

7 study, study. And we are attempting to

8 continually move towards a more integrated

9 synthesis and actually change the documents. 

10 And we welcome suggestions on how to make it

11 more effective because we find that, being in

12 a more dynamic or flexible approach to this,

13 that it has certain advantages to all of us.

14 So, is that speaking to your

15 question?

16 DR. SAMET: Yes. Thanks.

17 Yes?

18 DR. JACOB: I don't understand how

19 this ozone reconsideration proposal, does this

20 short circuit the formal revision of the

21 standard, which I understand is going to take

22 three years? Is this because this argues that
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1 a 2008 NAAQS was wrongly set?

2 MS. WEGMAN: Yes, it does not

3 short circuit it. These are two parallel

4 actions. One is a reconsideration.

5 And I should have noted this. The

6 reconsideration of the March 2008 standard is

7 based on the record for that review. So, we

8 didn't consider any new science. ORD did do

9 a provisional assessment of the new science to

10 ensure that there wasn't something that

11 materially changed the conclusions of the

12 scientific assessment for that March 2008

13 review. But we are looking only at the

14 scientific record and the entire record from

15 the March 2008 review for the reconsideration.

16 This is the next formal review,

17 the formal statutory five-year review of the

18 ozone standard. And so, it is somewhat

19 confusing, but they are moving forward in

20 parallel.

21 DR. SAMET: Just as a further

22 comment, you won't be aware, Daniel, but CASAC
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1 did comment quite recently on the

2 reconsideration. I think it was roughly

3 several months ago that we held --

4 MS. WEGMAN: Yes.

5 DR. SAMET: -- two lengthy

6 teleconferences. We heard from many public

7 commenters and again provided guidance to the

8 Administrator on the record as it had been

9 compiled up through 2006 in support of the

10 prior revision, the 2008 NAAQS. So, if you

11 are interested, there is a letter posted that

12 you can take a look at.

13 MS. WEGMAN: Yes. Does that help,

14 Daniel?

15 DR. JACOB: Yes.

16 MS. WEGMAN: Okay.

17 DR. SAMET: Howard?

18 DR. NEUFELD: Can you hear me now?

19 MS. WEGMAN: Yes.

20 DR. NEUFELD: Given the extended

21 length of time for the process, what is the

22 protocol or provisions if significant new
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1 findings come out, say, in the last two, two

2 and a half years of the process, that could

3 have an impact, say, on what your decision is?

4 DR. VANDENBERG: What we have done

5 is we certainly have found that the science is

6 changing. We have two rounds, if you will,

7 two documents here on the integrated science

8 assessments that we will be deriving. We can

9 bring new science into that, and we will try

10 to identify in a sense a deadline for

11 consideration of new studies that are coming

12 into the next document.

13 In the past, we have found CASAC

14 making recommendations to us to bring even

15 newer studies into the final document, and we

16 have done that in the past, based on a

17 recommendation from CASAC.

18 In addition, depending upon the

19 time it takes to move it into the policy, we

20 have done a provisional assessment in the past

21 of the new science to see if it will

22 materially change the conclusions that are
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1 represented in the ISA. We do that to the

2 benefit of the Administrator. So, that is

3 kind of a catchup at the very end, just to

4 make sure, is there anything out there that

5 the Administrator needs to be aware of prior

6 to making a final decision.

7 DR. SAMET: I think just as a

8 further comment, there has been an effort to

9 assure that these documents represent

10 systematic reviews where there is a clear date

11 up to which evidence is accumulated. And I

12 think as one goes beyond that point, this

13 discussion has come up many times and the

14 concern about potential selectivity in picking

15 one or another documents for consideration

16 becomes a critical matter.

17 So, if there are one or more key

18 studies, they might be brought forward, but

19 there is not an effort to continually update

20 the full systematic review. I think it is

21 simply not feasible.

22 MS. WEGMAN: Yes, and I will just
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1 note the Clean Air Act does provide for review

2 and revision, if appropriate, of these

3 standards every five years. So, there is a

4 recognition that new science will come along

5 toward the end of one review that will have to

6 come into consideration in the next review.

7 DR. SAMET: David?

8 DR. CHOCK: Just as a point of

9 clarification, the .06 to .07, I guess you

10 mean the fourth highest value in three years,

11 is that correct?

12 MS. WEGMAN: Yes, it is the fourth

13 highest maximum with an average of three

14 years, that's right, yes.

15 DR. SAMET: Okay, why don't we

16 move ahead?

17 DR. VANDENBERG: So, I think at

18 this point we will turn to Jim Brown to

19 provide the context for this review.

20 Jim?

21 DR. BROWN: I would just like to

22 follow up on the comment about when is the cut
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1 point for the science going into these

2 reviews. For the February/March 2006 air

3 quality criteria document, we had a number of

4 2006 epidemiological studies and I think two

5 controlled human exposure studies that were

6 added to that review. Following the second

7 external review draft, those were added to the

8 document, either because CASAC specifically

9 asked that they be included or public comments

10 pointed out new publications that were in

11 press and that should be included in the

12 review.

13 So, this is an evolving document,

14 the one that we are about to talk about today. 

15 The comments that we receive from you, the

16 comments that we receive from the public, we

17 do our best to respond to and incorporate in

18 relevant information.

19 So, on this first slide that I was

20 going to start with, it is just the chapters

21 in this first ISA. I felt pretty good about

22 where we were now with putting together this
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1 rather large document. I admit that, after

2 looking at slide 6, we have got a long ways

3 ahead of us to get to the end of this review,

4 and that is scary to me. But this is where we

5 are at this point.

6 So, on this slide, if you look

7 starting at the third chapter, we have

8 atmospheric sciences. You will see that we

9 also consider exposure, dosimetry, mode of

10 action. We look at health effects of short11 and long-term exposures, effects on

12 vegetation, and we also look at climate and

13 UV-B effects.

14 So, much like the backgrounds of

15 this Committee, we have a very diverse

16 background of individuals that have

17 contributed to this document. Later today,

18 when we go through the charge questions, we

19 will have people coming up to the table and

20 here that may help respond to questions or

21 provide clarifications to the Committee, if

22 those are desired.
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1 Now I am going to go ahead and

2 start going through the charge questions

3 quickly. Those relate back to the chapters

4 that I just showed you on slide 8. We have

5 charge questions specifically related to each

6 chapter.

7 This one, however, the very first

8 charge question relates to the entire

9 document. As John mentioned, there is a lot

10 of information. We have a lot of old

11 information that was very relevant to this

12 review and new literature.

13 With this copious amount of

14 research, we have tried to focus on what we

15 consider to be the most policy-relevant

16 information. So, some of the studies that may

17 have been included in old reviews, some

18 sections that were included in old reviews are

19 not included in this document. And we need

20 some guidance perhaps on what should be added

21 or removed even to make it more policy22 relevant and not such a large document.
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1 Moving to the next two charge

2 questions, well, the first chapter presents

3 the framework. We would like your opinion on

4 whether we have applied that appropriately for

5 this Ozone ISA.

6 And Chapter 2 provides an

7 integrated synthesis of our review and shows

8 you all of our causal determinations. And

9 again, we would ask if those were

10 appropriately applied.

11 So, on the topic of the causal

12 determination, it is a five-tiered assessment. 

13 We could move all the way from discerning that

14 there is likely, well, that there is a causal

15 relationship between an exposure to ozone and

16 a given health effect down to it not being

17 likely that there is a causal relationship.

18 On slide 13, this just overviews

19 some of the causal determinations that were

20 arrived at in our 2006 review and now our

21 conclusions in the 2011 ISA. This is for

22 human health effects from short- and long-term
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1 exposures.

2 On the top half of the slide, for

3 the short-term exposures, we don't really have

4 any change in what we concluded from the last

5 review.

6 On the bottom half of the slide,

7 we have long-term exposures being considered,

8 and we do have some new determinations there

9 that we would like the Committee's opinions

10 on.

11 We also have present causal

12 determinations. And on this slide, I have

13 just highlighted some of those for the

14 ecological systems effects and effects on

15 vegetation. Those range from likely causal to

16 causal.

17 Moving on to more specific

18 chapters, Chapter 3 is overviewed in charge

19 question 4. This overviews the atmospheric

20 sciences. And so, what we would like there

21 and what we have sought to provide is a useful

22 context and insights into the evaluation of
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1 human health effects on vegetation,

2 ecosystems, and climates. Did this chapter

3 support materials that we present later?

4 I have highlighted, I forgot to

5 mention to you there is highlighting on this

6 on some of these slides. And that is just to

7 emphasize some of the key points, at least as

8 I see them.

9 On this one, I have highlighted

10 4B. That is looking at policy-relevant

11 background. That becomes very important later

12 in the risk assessment in discerning the

13 effects due to human emissions on the ozone

14 levels.

15 And I think I will stop there and

16 move on to the next slide, which actually says

17 that. What is PRB? Well, PRB is the ozone

18 concentrations that would exist in the absence

19 of manmade emissions from the U.S., Canada,

20 and Mexico. So, North American emissions.

21 Well, PRB is not directly

22 measurable because we have those manmade
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1 emissions. And so, we have to model PRB.

2 We present some simulations in our

3 current assessment. We are continuing to work

4 on this. I mentioned that the document is

5 evolving. This is something that we are

6 working on for our second draft. We are

7 trying to look at a finer resolution, a half8 degree by two-thirds of a degree resolution

9 for North America nested in a 2-by-2.5 degree

10 resolution for a global model. On this plot,

11 the color is just illustrating the pressure.

12 But, with regard to this model,

13 and it is done by GEOS-Chem, and GEOS-Chem

14 considers or looks at ozone levels, NOx,

15 volatile organic compounds, and aerosol

16 chemistry. It is looking at 48 vertical

17 levels. I am sure if I continue on, I will

18 get something mixed up there, and so I won't.

19 (Laughter.)

20 But that is why we have

21 atmospheric scientists here for later in the

22 discussion today, when we do talk about the
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1 atmospheric chemistry and policy-relevant

2 background.

3 But we are working currently on

4 producing simulations for the years 2006

5 through 2008 to include in our second draft,

6 as opposed to what we have currently is a 1-

7 degree-by-1-degree resolution for North

8 America, which is roughly 100 kilometers, I

9 believe, by 100 kilometers.

10 Moving on to charge questions 5

11 and 6, this is looking at Chapters 4 and 5,

12 where we look at human exposures to ozone. 

13 And those are intended, again, to help us

14 understand and interpret some of the findings

15 in the epidemiological studies. Have we done

16 that appropriately and does it actually help

17 in the assessment of those epi studies?

18 Chapter 5, looking at dosimetry

19 and mode of actions, well, we look at

20 dosimetry to help us understand differences in

21 the dose received between individuals and

22 species. We look at modes of action to
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1 support the biological plausibility in the

2 epidemiological studies or observed in those

3 epidemiological studies.

4 Chapter 6, charge question 7 on

5 slide 19, you can see why I underlined key

6 phrases. This is looking at or discussing the

7 short-term effects of ozone exposure on human

8 health.

9 This is one of the chapters where

10 it really became apparent to me that we were

11 trying to balance out this old information

12 that we presented in former ISAs with some of

13 the newer information. Have we pulled in some

14 of the old, most relevant information? And

15 have we used toxicology adequately to support

16 the plausibility of those observations that we

17 are now seeing in some of the new

18 epidemiological studies?

19 Charge question 8 looks at, again,

20 human health effects, but now from long-term

21 exposures to ozone. I would like to slow down

22 on this slide for just a second to emphasize
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1 that we are looking at what I see as important

2 new findings. Specifically, we are looking at

3 the effects on new-onset asthma in children. 

4 We are looking at first childhood asthma

5 hospital admissions, increased asthma

6 severity, school absences. Children is what

7 I am emphasizing there.

8 And when I move a few slides later

9 and look at susceptibility, did we actually

10 present the susceptible groups appropriately? 

11 Especially children and asthmatics were two of

12 the large groups.

13 On slide 21, this is just included

14 to illustrate the large spectrum of evidence

15 that we are considering when we look at the

16 short-term and long-term human health effects. 

17 What is circled on this slide is mainly what

18 is new to this review, as in what we did not

19 have in the 2006 air quality criteria

20 document.

21 What is new? Again, as I

22 emphasized, I guess five out of those six
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1 circles relate to long-term exposures. As far

2 as the short-term exposures, we have

3 additional evidence of effects going down to

4 lower levels of exposure, that being 60 ppb in

5 some of the controlled human exposure studies.

6 I told you I would get to

7 susceptibility. That is our charge question

8 9. And these are just some of the different

9 characteristics that we looked at on slide 23

10 in considering the susceptibility.

11 Susceptibility is pulled together

12 out of our entire review. We have tried to

13 take the observations that we are seeing in

14 all the epidemiological studies and the

15 controlled human exposure studies and in the

16 tox studies that are presented in the earlier

17 chapters and pull those together into our

18 susceptibility chapter.

19 Moving on to our last two charge

20 questions on slide 24 -- I am getting tired

21 now from going through all of these that you

22 all are going to give us input on -- charge
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1 question 10 is looking at the effects on

2 vegetation and ecosystems. Charge question 11

3 is looking at the effects on climate and UV-B. 

4 There is a lot of information that is

5 presented in those chapters, especially

6 Chapter 9.

7 This is just a snapshot on slide

8 25 of some of that evidence. On slide 25,

9 this is the effects of ozone on plant growth.

10 In the leftmost panel, you will

11 see some plans for comparison to those in the

12 middle panel. Underneath each of those panels

13 is the cumulative weighted seasonal exposure

14 of those plants based on a W126 that was

15 presented in Chapter 9 and was also proposed

16 in the ozone reconsideration for the form of

17 our current standard.

18 Looking at the righthand panel,

19 that is just illustrating, if you couldn't see

20 it from the pictures, the actual loss in the

21 biomass as a function of the exposure

22 concentration.
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1 I would like to emphasize,

2 however, that this is a sensitive species. 

3 The cottonwood is not necessarily

4 representative of an average. It is a

5 sensitive species.

6 Lastly, this is just an overview

7 of the effects of ozone on climate. On the

8 third row down there, tropospheric ozone has

9 a positive radiating force on the climate.

10 And with that very quick overview

11 of some of the stuff that we have in this

12 document, I would like to move over to Debra

13 Walsh to discuss HERO.

14 DR. VANDENBERG: Would this be a

15 point for any questions or clarifications for

16 Jim?

17 DR. MILLER: Jim, why are you

18 willing to dismiss the cottonwood as a

19 sensitive species, but children we are

20 bringing in through the front door? I don't

21 see the connection there that you should say

22 that one is in an area, because of its eco or
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1 welfare, that, therefore, we are not going to

2 go with the most sensitive as opposed to the

3 health we are. Is that a charge of the Clean

4 Air Act or is that a policy already coming

5 into play?

6 DR. BROWN: Actually, I emphasized

7 that that is a sensitive species a little bit

8 because I believe the lower end of our

9 proposed range now was 7 ppm hours. I do see

10 effects on this slide. Actually, that is why

11 I went ahead and pulled this slide in. But I

12 was pointing out that that is not

13 representative of all species.

14 If we only looked at the

15 cottonwoods, there are clearly effects at the

16 7 ppm hours. And so, I was just trying to --

17 DR. VANDENBERG: It also isn't

18 dismissing this at all I think. It is just to

19 illustrate it, just to make a point.

20 DR. BROWN: I am sure we will come

21 back to this, as we plough through.

22 DR. VANDENBERG: Yes.
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1 DR. SAMET: Other questions or

2 clarifications?

3 (No response.)

4 Okay.

5 MS. WALSH: So, John has already

6 spoken about HERO, Health and Environmental

7 Research Online. So, HERO was a part of this

8 change in process when we were trying to

9 gather our information and use technology to

10 help us in the thousands of references that we

11 consider and, also, cite in our documents.

12 HERO is actually two parts. One

13 is the actual database that provides the

14 transparency to the stakeholders and the

15 public. And you can see that at epa.gov/hero.

16 The other piece is HERO Net. This

17 is the internal part of the HERO system that

18 we use, actually, to develop our assessments. 

19 It provides a way to be sustainable in these

20 large documents that we produce, and so many

21 of them in such a quick time.

22 The reason that we are trying to
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1 provide some extra slides here is because we

2 are really interested, and we don't have a

3 charge question on HERO, not that that is

4 appropriate, but I am very interested in your

5 input and your comments.

6 HERO is a very dynamic and agile

7 system. We have the developers for HERO as

8 federal staff. We listen to comments, what

9 works with the staff, what doesn't, public

10 commenters as well. We get a lot of comments

11 on the database.

12 We are using the information to

13 try to make it better. We deploy often. We

14 change. What works we keep; what doesn't work

15 we try to change.

16 I have already spoken to a few

17 CASAC members. If you are having trouble with

18 HERO, getting into HERO, please reach out to

19 us. We want you to be able to use this and

20 for it to be a resource for you.

21 This panel is the first one that

22 we have actually put in as reviewers into HERO
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1 Net. And we will show you a little bit later

2 what is different about that.

3 So, this is the public page. PM

4 was the first integrated science assessment

5 that we used HERO to put those blue links that

6 you see in the document. It takes you, when

7 you click on that link, if you are on the web,

8 it takes you to the HERO database. This is

9 just a screenshot.

10 This is the bottom part of that

11 first page. You can see, and I apologize for

12 the fonts here. It is a screenshot. So, the

13 resolution is not great. But you can see here

14 the integrated science assessments. If you

15 click on those tabs, you could actually see

16 the assessment.

17 You can see all the references

18 that are actually used and cited in the

19 document. You could export a bibliography of

20 that, if you wanted to.

21 When you look at the bottom part,

22 HERO was first developed for the ISAs, but we
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1 are very quickly trying to integrate this

2 system into our IRIS assessments that we do in

3 NCEA as well.

4 This is HERO Net. So, this is

5 what we use. It has some tools. If you look

6 at the top part above that line, that is very

7 much the same as the HERO database that the

8 public has access to. Below that line, you

9 will see where, instead of just search HERO,

10 the literature search. We have a federated

11 search that we use where we link in all of the

12 subscriptions and databases that EPA

13 subscribes to, as well as all the ones that

14 NCEA actually buys subscriptions to.

15 And instead of in the past, some

16 of you maybe can relate to this, where you

17 would have a journal with a routing slip, and

18 you would pass it around to people's offices. 

19 And after you finish, you pass it to your next

20 person. We now have ours electronically into

21 the literature search where the staff can do

22 that online. LitBrowser, LitCiter, these are
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1 all different tools that we use at different

2 parts of the assessment.

3 So, this was a page out of the PM

4 document. It was the first -- I think it was

5 the final, where we used LitCiter, which is

6 one of our tools. We actually link in the

7 reference into the assessment.

8 So, if you click on that link, we

9 have a HERO ID that is a unique number. That

10 helps us a lot in keeping our references

11 straight. As you can imagine, trying to

12 manage in some of our assessments 3,000-4,000

13 references, it was a challenge for us. So,

14 this helps us moving away from a paper-based

15 way.

16 You click on that. It goes to the

17 HERO ID, in this case. And this is what you

18 would see. So, the public sees this as well.

19 So, it is the abstract in most

20 cases, if we have that; the relevant metadata

21 that would be there on the citation. You

22 can't see it, at the bottom, where that
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1 reference was cited. As you can imagine, some

2 of our references are cited in numerous ISAs. 

3 All of that is listed there. So, you would be

4 able to see that.

5 And at the very bottom, that is

6 not captured here -- I apologize -- is

7 actually the DOI. So, the public could click

8 on that and take them to where they can get

9 that paper. A lot of papers we cite are in

10 Open Source. If you have a subscription to

11 that journal, you can get that with your own

12 password. And if you wanted to pay for that,

13 you could, or know how to go find that.

14 For ozone, we tried to, in being

15 responsive to not just what we had in-house,

16 but to now in transparency provide this to the

17 public, are actually the papers that we

18 considered but didn't actually cite in the

19 document.

20 So, in each of the chapters in

21 this first draft of the Ozone ISA, you will

22 see a link that takes you to this landing
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1 page. And when you click on this link, then

2 you will be able to go and see all the

3 references that were considered. You can,

4 then, select a box and go look at the

5 abstract.

6 We changed this. The Ozone ISA

7 was released in March, early March. And we

8 just in early May posted the Lead ISA. And in

9 that, we have changed, in that short period of

10 time -- as I mentioned earlier, HERO is a

11 really agile, evolving system. We get

12 comments and we try to change that.

13 So, on the Lead landing page for

14 whoever goes and looks at the Lead ISA that is

15 up, posted now on the web, you are able to go

16 to the link in that and see here the

17 references are actually not only listed, you

18 can see the ones that were cited as well as

19 considered. And there are actually some

20 filters here so you can look at discipline or

21 outcomes.

22 Where we are moving forward, ozone
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1 was the first ISA we did not have the

2 supporting material that we called annexes,

3 which was a lot of detailed tables with

4 information, that our goal as we move forward

5 with HERO is to put that type of information,

6 actually the numbers, into HERO in a module we

7 call LitExtractor, where you would be able to

8 query and run a report and get that

9 information out to how you would like to look

10 at that.

11 That is a big undertaking, as

12 anyone here can imagine. We have done

13 different trials with that, and we are trying

14 to get that as soon as we can.

15 But, in the process, to go between

16 the paper Annex tables and before we can get

17 the full LitExtractor deployed, we are doing

18 what is called this LitReporter. So, this is

19 what we are proposing to do for the NOx ISA,

20 which is the next pollutant that we will

21 start.

22 And it is going to have a list of
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1 the references and the different metadata that

2 you would pull out of that paper, as well as

3 findings field that will, then, point you to

4 the actual table or figure where some of that

5 information is actually at.

6 This is just a screenshot of our

7 beginning thinking about NOx. We are really

8 trying, as we move forward, to be in a more

9 systematic way to capture what we are

10 evaluating and how we are providing access to

11 that.

12 And then this is just the meeting

13 agenda, how we guide the rest of the day,

14 looking at the charge questions, and our time.

15 So, I would welcome any comments,

16 and would please encourage, we want you to use

17 HERO. We want you to use HERO Net. If you

18 have any difficulties -- I know a letter was

19 sent out. So, please feel free to call us in

20 that information, and we will walk you through

21 that. I am here all day and tomorrow. You

22 know, catch me in the hall. I want to do
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1 whatever I can to make this work for you.

2 DR. SAMET: Fred?

3 DR. MILLER: Debra, this is "one

4 giant step," a Neil Armstrong analogy, for

5 ISAs. I mean it is a tremendous step forward

6 for the agency in being able to assimilate

7 this information.

8 I had one quick question about, if

9 we are discussing today papers that we think

10 should be added in that, how is the process

11 where you now take it off of a considered

12 list, and is that something that has to

13 actually be done manually with each one? Or

14 how can you make this job doable on those

15 kinds of refinements?

16 MS. WALSH: So, it is a matter of

17 changing a tag of how that would move. That

18 is not an issue.

19 One of the things, not to

20 elaborate about HERO because I know we are

21 kind of running short on time, but, as we were

22 just speaking earlier, some of the comments
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1 about trying to capture those new studies that

2 are coming out and trying to look in a way to

3 keep up with the literature, you know, we are

4 really working with HERO, particularly in this

5 new literature searching that we are doing

6 with the discovery service.

7 We had had a federated service

8 earlier that we had subscribed and built, very

9 similar to what you have at universities, how

10 you can look at multiple databases

11 simultaneously and then remove duplicates and

12 those kinds of things. EPA is working toward

13 that. HERO kind of got in front of that

14 because we are the largest user probably, at

15 least in our facility, of literature like

16 this.

17 We had moved from reams of paper,

18 as we were talking to someone earlier, paper

19 references to get that to an electronic way,

20 where you don't go to a library as such to

21 pull that information.

22 We are really trying for HERO to
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1 be an evergreen system where there's constant

2 searches being run. So, the staff is going to

3 have that popping up to them in a way that is

4 whatever we decide is appropriate, weekly,

5 monthly, whatever those studies would show up.

6 DR. SAMET: Howard?

7 DR. NEUFELD: You mentioned that

8 you can find out which document a reference is

9 cited in. Can you also get it down to the

10 page and line number, so you could see where

11 all the -- like if one article is cited 10

12 times in the ISA, you could find out exactly

13 where it was cited in the document?

14 MS. WALSH: No. That's a good

15 question, but, no. We haven't moved to that

16 yet.

17 DR. VANDENBERG: But you can put

18 in, like Adobe, you can put in a search

19 defined field --

20 MS. WALSH: Yes.

21 DR. VANDENBERG: -- and it will

22 roar through it and find all those places for
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1 you. That is using an Adobe feature, not a

2 HERO feature.

3 MS. WALSH: But at the moment you

4 can't do that, but you will be able to as we

5 build more in our LitReporter module. This is

6 a relational database, an Oracle relational

7 database, where you will be able to run

8 standard queries as we build that in reports

9 and actually build your own. So, you would be

10 able to see how many ISAs this particular

11 paper was cited in, rather than trying to

12 click through that yourself. To go to the

13 actual page number, we haven't looked at

14 trying to add that kind of information.

15 DR. SAMET: Judy?

16 DR. GRAHAM: What you are doing is

17 just amazing, just amazing. A suggestion.

18 MS. WALSH: Okay.

19 DR. GRAHAM: You talked about what

20 you are going to do for the NOx document. And

21 the impression I got is you are going to use

22 this system to create tables.
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1 Given the massive amount of work

2 involved, and at least in my mind the vast

3 importance of tables, it just might be a good

4 idea if you had, let's say, a couple of drafts

5 that you shot out to CASAC, to avoid having to

6 redo things later.

7 MS. WALSH: Absolutely. That is

8 why we are putting you in HERO Net. The

9 general public is not in HERO Net. I mean how

10 we have tried to be very careful, because we

11 are very concerned about copyright and not

12 infringing upon that, but as you look at how

13 we are interpreting the copyright law, it is

14 that it is for researchers.

15 And so, our team, our research

16 team, certainly had included OAQPS, not just

17 NCEA, and those other collaborators that work

18 closely with us on some of our projects we put

19 in there. And this is the first time we have

20 expanded with ozone and to include the

21 reviewers in the CASAC panel as part of our

22 partners working with us. And we think that
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1 is appropriate, to put you in HERO Net.

2 DR. SAMET: Okay. Let me check

3 this. Anyone on the phone want to ask a

4 question? I have been ignoring you. Out of

5 sight, out of mind.

6 (No response.)

7 Okay. All right. Any other

8 questions for EPA, for the staff, before we

9 move on to the public comments?

10 (No response.)

11 Great. I am sure we will have

12 many questions later in the day.

13 Okay. Thank you.

14 So, we will move on, then, to a

15 public comment period. And I have four public

16 commenters listed, two of whom will be on by

17 phone.

18 Just as a reminder, you have been

19 allocated five minutes for your public

20 comments. I am holding my trusty stopwatch in

21 hand. I will give you a warning when you have

22 30 seconds left. And I do ask that, when you
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1 have completed your five minutes, when I say

2 your five minutes are up, please to end.

3 And for the panel members, if you

4 have questions, clarifying questions or

5 whatever, we will take those right after each

6 of the public commenters.

7 So, let me begin. Our first

8 public commenter is Sam Oltmans from Boulder,

9 Colorado.

10 Let's see, are you on the phone?

11 (No response.)

12 Okay. Then, we will move on to

13 our next public commenter, Allen Lefohn.

14 DR. LEFOHN: Where would you like

15 me?

16 DR. SAMET: There is a spot right

17 up there for public comment.

18 DR. LEFOHN: All right. We're

19 good. I was going to say, do you want me to

20 talk about W-126?

21 Good morning.

22 Let me get my thing going.
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1 My name is Allen Lefohn. I am

2 from Montana. I would like to focus on PRB

3 this morning.

4 PRB concentrations we are talking

5 about should be characterized as hourly

6 average concentrations, is my opinion. PRB's

7 temporal characterization should reflect the

8 way in which it is to be applied in various

9 policy aspects, the requirements for one-hour

10 PRB inputting to the risk analysis, based on

11 controlled human laboratory and vegetation

12 studies.

13 By characterizing PRB as hourly

14 average concentrations versus, let's say,

15 multi-month-type averages, I believe it is

16 more meaningful for a comparison with

17 empirical data, such as from Trinidad Head,

18 California, where they can be performed. And

19 Trinidad Head is a site that experiences PRB

20 conditions many times during the springtime.

21 At Trinidad Head, California, the

22 range of maximality concentrations for the
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1 month of April over the period is 54 to 65

2 ppb. Generally, during April through May, the

3 monthly mean of the daily maximum eight-hour

4 average is approximately 45, with the number

5 of hourly average concentrations greater than

6 or equal to 50 ppb for April varying from 30

7 to 187. Daily eight-hour average

8 concentrations greater than or equal to 50 are

9 observed on a regular basis during the

10 springtime.

11 Seasonal preference for enhanced

12 ozone concentrations, that is greater than or

13 equal to 50 ppb for Denali, Glacier,

14 Yellowstone, and Voyageurs, reference size

15 during the springtime.

16 And important contributor to PRB,

17 sufficient evidence exists to illustrate that

18 stratosphere to tropospheric transport

19 processes contribute to background ozone

20 concentrations at the surface of both high21 and low-elevation monitoring sites. The key

22 question is, how frequently do they
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1 contribute?

2 Current estimates of the

3 stratospheric contribution is being performed

4 by our research team. The team consists of

5 Lefohn, Wernli, Shadwick, Limbach, Oltmans,

6 and Shapiro.

7 The trajectory model, LAGRANTO is

8 used to identify days when STT-S enhances

9 hourly average concentrations greater than or

10 equal to 50 ppb. An example of the frequency

11 of STT-S events for a high-elevation site,

12 which we consider to be the gold standard,

13 meaning this is a site that we believe is

14 being enhanced by the stratosphere very

15 frequently, again, April and May predominate

16 for 2006, 2007, and 2008.

17 For a low-elevation site in

18 Chittenden County, Vermont, again, April and

19 May predominate, but there is variability from

20 year to year that occurs.

21 This statistically-significant

22 relationship between STT-S and ozone hourly
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1 average concentrations greater than or equal

2 to 50 ppb for the 2006-to-2008 period for

3 Yellowstone, it shows March through August for

4 2006; March through September 2007; March

5 through July 2008. The numbers in parentheses

6 reflect the number of days that STT

7 contributed to the enhancement.

8 For Chittenden County, again,

9 because of the variability that exists, April

10 2006, 19 days; April 2008 and May 2008, 20 and

11 17. We had no relationship during 2007.

12 Statistically-significant

13 relationships between STT-S and ozone greater

14 than or equal to 50, additional sites that we

15 examined for Cheeka Peak; Trinidad Head;

16 Denali; Glacier; Burke County, North Dakota;

17 Voyageurs; Crandon in Wisconsin; Presque Isle

18 in Maine, and Washington County, Maine, all

19 showed statistically-significant relationships

20 in these early elevations on the right.

21 When statistically coincidences

22 occurred at the high-elevation site, the daily
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1 maximum hourly springtime averages were

2 usually in the 60-to-70-ppb range, the maximum

3 daily eight-hour in the 50 to 65. At many of

4 the lower-elevation sites, the daily maximum

5 hourly average concentrations were mostly in

6 the 50 to 65, and the daily eight hour, 50 to

7 62.

8 Concluding remarks: the frequency

9 of SST-S events is greater at higher elevation

10 than at lower elevation sites, but both are

11 frequent during the springtime. And

12 statistically-significant relationships are

13 observed between SST-S and daily maximum

14 hourly averages in concentrations greater than

15 or equal to 50 --

16 DR. SAMET: Thirty seconds.

17 DR. LEFOHN: -- at both high- and

18 low-elevation sites during the springtime and

19 sometimes during the summertime.

20 Final remark: besides being

21 important for determining the emission

22 reductions required for attaining an ozone
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1 standard, the level of PRB also affects the

2 risk estimates. PRB ozone concentrations

3 should be characterized as hourly average

4 concentrations because of import requirements

5 associated with the risk analysis,

6 methodologies for controlled human laboratory,

7 and vegetation studies.

8 Thank you.

9 DR. SAMET: Thank you.

10 You had barely a second left. 

11 Very good.

12 (Laughter.)

13 One question: it sounds like you

14 have an ongoing program of research. Could

15 you say what are you doing and who is funding

16 it?

17 DR. LEFOHN: Okay. The API is

18 funding this research. The API also funded my

19 research for the AOT 90 adjusted for the human

20 health that we came out with last year with

21 Milan Hazucha and Dr. Adams, Drs. Hazucha,

22 Adams, and Chadwick, and W126 they also
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1 funded.

2 DR. SAMET: Okay. Thank you.

3 DR. LEFOHN: Thank you.

4 But can I also add one quick point

5 to your question? It is ongoing, and there

6 are 12 sites where we looked at it, phase 2. 

7 We have now looked at 36 sites over the 2006-

8 to-2008 period.

9 DR. SAMET: Okay. Thank you.

10 Other questions?

11 DR. MILLER: I have one.

12 DR. SAMET: Yes, Fred? Fred?

13 DR. MILLER: You talked about

14 hourly averaging, and the EPA presentation

15 referred to the fact that the PRBs would be

16 modeled. Is there any difficult from your

17 perspective that this could, in fact, move

18 over? Because my own feeling would be that

19 you would be doing a cumulative, weighted

20 average moving with time through the year, not

21 just making it seasonal. And I think the

22 computational power is there to do it.
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1 So, I am curious what you are

2 meaning, if there is a difference on how it

3 could be implemented or not from your

4 recommendation.

5 DR. LEFOHN: Well, let me see if I

6 said that right. The input last time, and I

7 think the recommendation this time in the

8 risk, is for hourly average concentrations to

9 go into the risk for some of the analysis, for

10 the W126 and for the personal exposure part of

11 the human health risk.

12 Last time, what was done was that

13 they used the diurnal patterns. On page 2-55

14 of the staff paper, it says we provided, we,

15 EPA, provided the diurnal patterns, the one

16 o'clock average, the two o'clock average, the

17 three o'clock average, for April through

18 September. There was a problem with that, in

19 my opinion.

20 And that problem was where we talk

21 about PRB being a range of 15 to 35 ppb in the

22 last criteria document, when that diurnal
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1 pattern was averaged, it was really 15 to 25

2 ppb. Occasionally, it reached 30 and 35. But

3 it was the smoothing of use of the monthly

4 diurnal pattern.

5 As far as how the model goes and

6 such like that, Daniel Jacob and I have had

7 conversations on this and such. And I am sure

8 that he will be able to expand on that.

9 DR. SAMET: Daniel?

10 DR. JACOB: I can expand and

11 follow up as a question to Allen. Yes. Okay. 

12 So, right now, the model POD calculations, as

13 described in the ISA, are based on the MDA and

14 the AR daily maximum averages. And the model

15 can capture a very large fraction of a

16 variability that you describe, except at the

17 very, very high extremes. Like the models

18 cannot get 100 ppb at Yellowstone. But, aside

19 from that, the models can get really all the

20 variability stretching to 70-75 parts per

21 billion.

22 And my question to you is, what do
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1 we gain by going from this capture of the

2 diurnal variation of the PRB, day-to-day

3 variation of the PRB, to going to the hourly

4 variability, which the models I think would

5 have a harder time capturing?

6 DR. LEFOHN: Well, I am not sure

7 the models are capturing it that well. For

8 example, at Trinidad Head, if someone were to

9 take -- and I have not seen -- I guess I have

10 looked at some of the 2001 maps in the ISA. 

11 It shows, I don't know, 20 to 35 ppb. But

12 those are average. Those are two-month

13 averages for the springtime, April and May.

14 So, my point is, No. 1, for the

15 W126, I believe the hourly average

16 concentrations are going to be required in

17 there of PRB. The eight-hour daily max that

18 is in the appendix and such like that is a

19 good start at being able to compare against

20 the empirical data that are seen, PRB

21 conditions.

22 Trinidad Head is a very good site. 
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1 We think we are seeing stratospheric

2 contribution or we believe we are seeing

3 stratospheric contribution at the low4 elevation sites. I believe using some of the

5 information there of higher resolution, and

6 not the multi-month-type averages, begins to

7 get at the contribution of the stratosphere at

8 the lower-elevation sites, which is very, very

9 important.

10 DR. SAMET: Okay. Any other

11 clarifying questions?

12 (No response.)

13 Okay. Thank you.

14 DR. LEFOHN: And Sam Oltmans may

15 be available. He was supposed to be.

16 DR. SAMET: Okay. That's fine. I

17 will come back to him and see if he is

18 available.

19 Okay. Our next presenter is Julie

20 Goodman from Gradient Corporation, on behalf

21 of the American Petroleum Institute.

22 Julie?
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1 DR. GOODMAN: Thank you for the

2 opportunity to --

3 DR. SAMET: Why don't you wait? 

4 Do you have slides?

5 DR. GOODMAN: I do not.

6 DR. SAMET: Oh, you do not? Okay. 

7 Go ahead then.

8 DR. GOODMAN: Are you going to

9 start the timer over?

10 (Laughter.)

11 DR. SAMET: Go for it.

12 DR. GOODMAN: Thanks for the

13 opportunity to speak today.

14 The ISA does not provide evidence

15 to support a lower ozone NAAQS than the

16 current primary standard. The weight of

17 evidence from controlled human exposure

18 studies indicates that there are no effects on

19 lung function associated with ozone exposures

20 below 72 ppb, and this is consistent with

21 biological data that support a threshold

22 mechanism of action.
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1 Group mean changes in FEV1 were

2 statistically-significant, although not

3 clinically-relevant, in only one of four

4 studies examining 60 ppb. So, one must

5 conclude this association cannot be

6 interpreted as causal.

7 Now much has been made of the

8 Adams 2006 study, which indicated that

9 controlled exposure to 60 ppb ozone did not

10 result in a statistically-significant group

11 mean change in FEV1. And I have previously

12 provided comments to CASAC on the

13 inappropriate re-analysis of Adams by Brown,

14 et al., in 2008.

15 This re-analysis resulted in a

16 statistically-significant group mean decrement

17 in FEV1 at 60 ppb, but this can be attributed

18 to the majority of the data being selectively

19 omitted from the analysis.

20 EPA has not addressed another re21 analysis of the Adams 2006 data by Nicholas

22 2007, nor an analysis of five controlled human
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1 exposure studies, including Adams 2006, by

2 Lefohn in 2010, who just spoke. Both of these

3 analyses did not find a statistically4 significant group mean FEV1 decrement with

5 exposure to 60 ppb ozone.

6 EPA has given no scientifically7 acceptable justification for relying on the

8 Brown analysis over the original analyses

9 conducted by Adams or those of Nicholas or

10 Lefohn, which used methods that are more

11 appropriate for the study design and indicated

12 there is no association between exposure to 60

13 ppb ozone and lung function decrements. In

14 the ISA, EPA should recognize and give greater

15 weight to analyses using these methods.

16 The most recent controlled human

17 exposure study by Kim, et al., in 2011,

18 measured FEV1 at several time points during

19 the exposure period, but only analyzed the

20 data from the pre- and post-exposure time

21 points, an approach that is likely to have led

22 to false-positive results.
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1 Also, while the authors reported a

2 statistically-significant group mean change in

3 FEV1 after 6.6 hours of exposure to 60 ppb

4 ozone, the lung function effects were not

5 adverse, according to broadly-recognized

6 clinical guidelines. The available evidence

7 indicates that adverse lung function effects

8 are only observed at controlled ozone

9 exposures of at least 88 ppb.

10 But, regardless of the statistical

11 method used, EPA should acknowledge that it

12 cannot be determined whether any large

13 decrements in lung function in particular

14 individuals in these exposure studies are

15 representative of a generalized effect of

16 ozone exposure. These studies were not

17 designed to determine whether effects in

18 individual subjects are attributable to ozone

19 and should not be re-analyzed or interpreted

20 as such in the ISA.

21 In addition, one cannot determine

22 whether there would be a population shift in
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1 FEV1 decrements based on the small number of

2 individuals in the controlled exposure

3 studies. Using the results of these studies

4 to make broad conclusions about large

5 populations is at variance with the criteria

6 of the American Thoracic Society, which draw

7 a clear distinction between small changes in

8 lung function in individuals from exposure

9 studies and small, but statistically10 significant reductions in lung function of a

11 population, as derived from observational

12 epidemiology studies.

13 EPA has also not addressed how the

14 controlled exposure studies, as well as other

15 biological data, indicate a threshold mode of

16 action for the effects of ozone on lung

17 function. For example, it has been shown that

18 antioxidants react with ozone in a time- and

19 concentration-dependent manner in the

20 respiratory tract, and it is only when these

21 defenses are saturated that ozone can cause

22 adverse effects. EPA should address these
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1 data, as well as the clear evidence for a

2 threshold from the controlled exposure

3 studies, in the ISA.

4 Now, moving on to the

5 observational epidemiology data, EPA does not

6 document its methods and criteria for

7 identifying the studies to be reviewed. This

8 results in a lack of transparency in the

9 assessment, as it is unclear how many studies

10 with null results may have been omitted from

11 the evaluation.

12 In addition, the ISA does not

13 sufficiently describe EPA's methods for

14 evaluating the strengths and limitations of

15 the selected studies, which leads to an

16 inconsistent evaluation of individual studies. 

17 EPA emphasizes positive associations, whether

18 they are statistically-significant or not, and

19 often discounts null results.

20 Furthermore, there is no clear

21 framework presented for evaluating the weight

22 of evidence in establishing causation, which
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1 leads to inconsistent and often ad-hoc

2 approaches to hazard identification.

3 Finally, the ISA does not define

4 the concept of consistency of findings within

5 and among studies, leading to conclusions

6 about causation that appear to be based on a

7 subjective view of the overall data.

8 As I pointed out in my written

9 comments, these points are consistent with

10 those of a Committee assembled by the National

11 Research Council of the National Academy of

12 Sciences, who reviewed EPA's draft IRIS

13 assessment for formaldehyde. They noted that

14 other NRC committees have identified --

15 DR. SAMET: Thirty seconds.

16 DR. GOODMAN: -- the same issues

17 in a number of EPA's IRIS assessments over the

18 last decade.

19 In closing, a scientifically20 rigorous analysis did not support a causal

21 relationship between ozone exposure and health

22 outcomes evaluated in the ISA at exposure
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1 levels below the current NAAQS.

2 DR. SAMET: Okay. Thank you.

3 I do have to point out, as Chair

4 of the Committee that reviewed the IRIS

5 formaldehyde assessment, that, in fact, in

6 Chapter 7, the process of the ISA, and so on,

7 is actually highlighted as one that

8 represented a major shift in how the agency

9 was conducting its reviews that had led to a

10 greater transparency. So, I believe that

11 needs to be made clear in your appendix, which

12 does draw on that document, Chapter 7, that,

13 in fact, there was additional material related

14 specifically to this process.

15 Others? Fred?

16 DR. MILLER: Your statement

17 relative to the Kim study and the fact that

18 they analyzed at this end of the six hour,

19 leading to a false-positive, is beyond

20 credulence. That study had adequate

21 statistical power compared to any other

22 clinical study at the 60 part per billion. 
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1 And moreover, when you are looking at the

2 decrement, you would have also seen a

3 significant time trend. So, it is beyond me

4 how you can claim that that would lead to a

5 false-positive.

6 DR. GOODMAN: Because when Kim did

7 the analysis, they didn't account for all of

8 the time points that they looked at. They

9 only --

10 DR. MILLER: That doesn't matter. 

11 The point is that the overall trend and the

12 time period that they were comparing in their

13 hypothesis relative to the other extended

14 exposures was the final point, and it is valid

15 statistically.

16 I have a doctorate in statistics,

17 and I can tell you I looked at the Brown

18 analysis and they did acceptable statistical

19 evaluations. There are different ways to

20 analyze data depending on what your hypothesis

21 is.

22 DR. GOODMAN: I think that you
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1 have to consider that several other people

2 have done statistically/scientifically3 appropriate analyses which I would argue are

4 more appropriate than the Brown analysis, and

5 they found no statistical association. And

6 there is really no argument to discount those,

7 first of all.

8 And, second of all, you need to

9 consider that, even if it is statistically

10 significant, the decrements are so small, they

11 are not clinically-relevant.

12 DR. SAMET: Well, we will return

13 to these issues when we look at that chapter.

14 Other questions?

15 (No response.)

16 Okay. Thank you, Julie.

17 Next, George Wolff. George, are

18 you on the phone?

19 MR. WOLFF: Yes, I am, Jon.

20 DR. SAMET: Okay. So, next we

21 will hear from George Wolff, Air Improvement

22 Resource, Inc., on behalf of the Utility Air
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1 Regulatory Group.

2 George, anytime, please.

3 DR. STALLWORTH: I would like to

4 say that George's slides are on the CASAC

5 website, if you want to follow along on your

6 laptop.

7 DR. SAMET: Okay. Are they going

8 to be shown?

9 DR. STALLWORTH: No.

10 DR. SAMET: We don't have them

11 here.

12 Okay. Okay, fine. George, go

13 ahead anytime.

14 MR. WOLFF: Thank you.

15 In the REA health plan, EPA

16 states, and quote: "We will likely consider

17 several different background definitions, U.S.

18 background, North American background, and

19 natural background." I strongly endorse EPA

20 considering different backgrounds.

21 The EPA modeling plan includes the

22 GEOS-Chem modeling system, which will be run
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1 using emissions and meteorology for three

2 annual periods, 2006 to 2008. The GEOS-Chem

3 model will be run using two nested grids. The

4 outer grid will be global in extent to utilize

5 the grid resolution of 2 degrees by 2.5

6 degrees. The inner grid will be centered over

7 North America and use a horizontal resolution

8 of .5 to .67 degrees, and four scenarios will

9 be modeled. These are welcome improvements to

10 the previous ISA.

11 Different background scenarios

12 that are proposed by EPA: first, the base

13 case simulation will be completed using all

14 global, anthropogenic, and natural emissions. 

15 A model performance evaluation will be

16 completed for this scenario.

17 Second, U.S. anthropogenic

18 emissions of NOx, non-methane VOC, and CO are

19 set to zero. All anthropogenic emissions

20 outside the U.S. are maintained at the current

21 level.

22 And, third, U.S., Canadian, and
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1 Mexican anthropogenic emissions are set to

2 zero.

3 And, fourth, all global

4 anthropogenic emissions are set to zero.

5 However, as I will show shortly,

6 these scenarios address the wrong questions.

7 I applaud this four-tiered

8 approach because GEOS-Chem runs used by EPA in

9 its 2007 risk assessment significantly

10 underestimated PRB because it underestimated

11 the stratospheric and tropospheric

12 contributions. It underestimated natural NOx

13 emissions. It underestimated Asia-Pacific NOx

14 emissions. It used outdated chemistry and

15 physics. The grid resolution was too coarse. 

16 And monthly means of the diurnal PRB profiles

17 are inappropriate to use for a max that is

18 based on the three-year mean of the fourth

19 highest eight-hour value.

20 However, I feel the definition of

21 PRB is also inappropriate. EPA assumes that

22 it has the power to control emissions in
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1 Mexico and Canada. By not including these

2 emissions in PRB, EPA assumes a treaty could

3 eliminate it. It penalizes states that must

4 come up with additional control measures to

5 compensate for Mexican and/or Canadian

6 emissions. EPA needs to redefine PRB to

7 include emissions from all foreign countries,

8 including Canada and Mexico.

9 EPA is asking the models the wrong

10 question. EPA is asking, what would the ozone

11 be in the U.S. if the U.S. had no

12 anthropogenic emissions? This is a

13 meaningless question. The answer has no

14 relevance to control strategies. It has no

15 relevance to risk assessment. It answers

16 questions about a fictitious atmosphere.

17 The correct question to ask is,

18 what are the contributions from sources that

19 EPA has no control over? There are two ways

20 to answer this question.

21 First, you can use GEOS-Chem, run

22 a base case. The second run would zero-out
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1 natural emissions and get the natural

2 background.

3 Third would be zero-out natural

4 and foreign anthropogenic emissions, and

5 subtracting this from the base case, you would

6 get the revised PRB.

7 And fourth, zero-out Mexican and

8 Canadian anthropogenic emissions, and

9 subtracting that from the base case, you would

10 get the Canadian and Mexican contribution.

11 You could also do this using a

12 combination of CAMx and GEOS-Chem where the

13 GEOS would compute boundary conditions and

14 CAMx would be used for proportion.

15 Finally, my recommendation: PRB

16 should be redefined to include Canadian and

17 Mexican anthropogenic contributions. I

18 support EPA's new modeling effort with the

19 modeling --

20 DR. SAMET: Thirty seconds.

21 MR. WOLFF: -- emission scenarios.

22 Emission scenarios should be modified so that
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1 all U.S. anthropogenic emissions are included

2 in all scenarios.

3 I strongly support a rigorous

4 model performance evaluation on the base case,

5 and the ISA should be revised to include the

6 modeling plan.

7 Thank you.

8 DR. SAMET: Okay. Thank you.

9 Questions?

10 (No response.)

11 Okay. I guess not.

12 Thank you, George.

13 Let me check, is Sam Oltmans on

14 the phone?

15 DR. OLTMANS: Yes, I am.

16 DR. SAMET: Okay. Let's see, do

17 you have slides?

18 DR. OLTMANS: I do.

19 DR. SAMET: Let's see, Holly, do

20 we have them?

21 DR. STALLWORTH: We don't have

22 them loaded on the laptop.
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1 DR. SAMET: I'm sorry, I guess we

2 don't have your slides available.

3 DR. OLTMANS: I was told they were

4 at least loaded onto the website.

5 DR. SAMET: Loaded on the website. 

6 Okay.

7 Why don't you go ahead, then?

8 DR. OLTMANS: Okay. My name is

9 Sam Oltmans. I am a recently-retired research

10 scientist with the NOAA Research Laboratory in

11 Boulder, Colorado. These comments are being

12 provided by me as a private individual.

13 A significant portion of my

14 research career has been devoted to measuring

15 and understanding background ozone in the

16 atmosphere.

17 Next slide.

18 Although a policy-relevant

19 background is not a directly-measured

20 quantity, I believe it is very important to

21 make measurements of what I will term

22 "background ozone", not only as a validation
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1 tool for models, but, also, as a quantity that

2 can be directly compared with measurements

3 made at locations that must meet air quality

4 compliance requirements.

5 I established the Ozonesonde

6 Program at Trinidad Head in 1997 and the

7 surface ozone-monitoring program at this site

8 in 2002 for the express purpose of measuring

9 baseline ozone entering the West Coast of the

10 U.S. As I will discuss later, the relatively11 remote exposed location at Trinidad Head is a

12 well-located site for measuring and

13 understanding background ozone.

14 Skip to slide 4.

15 I have published several papers

16 describing tropospheric ozone at this site,

17 focusing on the representativeness of the

18 ozone measurements and characterizing the

19 ozone background entering the West Coast of

20 the U.S., and understanding the processes that

21 contribute to this background ozone signal.

22 In the spring, Trinidad Head
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1 consistently sees ozone mixing ratios greater

2 than 50 ppb, an April average of over 45 ppb,

3 and a range of maximum hourly averages between

4 54 and 65 ppb. At the top of the boundary

5 layer, based on the Ozonesonde data at

6 approximately 2 kilometers, average ozone

7 mixing ratios are 50 ppb in both the spring

8 and the summer.

9 Next slide.

10 We have used both trajectories and

11 local wind information to determine conditions

12 representative of air coming off the Pacific

13 Ocean. During the daytime hours, the ozone

14 measured at Trinidad Head is overwhelmingly

15 representative of the marine background. This

16 is the conclusion of a number of studies in

17 addition to our own.

18 Next slide.

19 Vertical measurements of both

20 ozone and carbon monoxide provide additional

21 information on the representativeness of the

22 Trinidad Head observations for determining
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1 background levels of ozone.

2 Regular aircraft measurements

3 above Trinidad Head, which measure a number of

4 trace species, including carbon monoxide and

5 ozone, show that air coming onshore at the

6 observation location has levels of carbon

7 monoxide that are representative of global

8 background at that latitude, at the latitude

9 of the station, implying that we are measuring

10 background ozone signal as well.

11 An intensive six-week campaign of

12 daily Ozonesonde measurements at six sites in

13 California in May and June of 2010, as part of

14 CalNex, showed that ozone measured at sites

15 running along the coast of California have

16 similar average concentrations to Trinidad

17 Head in the lower troposphere. Thus, ozone

18 measured at Trinidad Head is generally

19 representative of air entering the coast of

20 California.

21 Next slide.

22 From the CalNex data, when we
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1 screened the data below 3 kilometers for

2 possible North American influence, there is

3 essentially no difference in ozone amounts

4 from the complete set of measurements and, in

5 fact, there is slightly less ozone when North

6 American influence is included.

7 Interior continental locations can

8 also provide information on background ozone

9 levels. An example at Denali National Park in

10 Alaska shows that the highest ozone amounts at

11 this remote site are not associated with North

12 American influence, but, rather, long-range

13 transport from Eurasia.

14 Slide 9.

15 Careful analysis of data from

16 several relatively-remote locations shows

17 that, when local effects such as land/sea wind

18 circulation at Trinidad Head or

19 downslope/upslope circulation --

20 DR. SAMET: Thirty seconds.

21 DR. OLTMANS: -- at mountain

22 locations at Niwot Ridge, that such locations
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1 can provide information on background ozone.

2 The conclusions are that Trinidad

3 Head is a well-located site for monitoring air

4 entering the West Coast of the U.S. 

5 Understanding of measurement conditions at a

6 continental site can yield important

7 information on background ozone. Intensive

8 ozone observations confirm that ozone measured

9 at Trinidad Head --

10 DR. SAMET: Okay, five minutes are

11 up. Thank you for your presentation.

12 DR. OLTMANS: Okay.

13 DR. SAMET: Sorry, I don't think

14 we have --

15 DR. STALLWORTH: No, I don't think

16 I have the slides posted. I am just checking

17 my email. I got a text file from you, but I

18 don't think I got PowerPoint slides.

19 DR. OLTMANS: No, I have an email

20 message that --

21 DR. STALLWORTH: Okay.

22 DR. OLTMANS: -- says you loaded
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1 those onto the site.

2 DR. STALLWORTH: George found

3 them. You said they are posted? Okay. I was

4 looking for one that just had Oltmans. So, it

5 is the Oltmans and Lefohn slides. Okay.

6 DR. SAMET: There is a text file. 

7 I did not see, actually, a PowerPoint

8 presentation.

9 Yes, you might, I think to

10 supplement the presentation, it would be

11 useful to get them. We will get them posted,

12 so that we can see them.

13 Maybe it was hard to follow since

14 we do not have the slides, but I wonder if

15 anyone has any clarifying questions.

16 (No response.)

17 Any of the CASAC members on the

18 phone, I have not forgotten that you are there

19 completely.

20 (No response.)

21 No? Okay.

22 Then, let me thank the public for
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1 your comments and input.

2 Now, actually, this happens

3 sometimes, we are ahead of schedule. And what

4 I think we should do is proceed to take a

5 break, and let's get back together at 10:15

6 and, then, go on with a discussion of the

7 charge questions.

8 Deborah Shprentz is not

9 commenting.

10 (Whereupon, the foregoing matter

11 went off the record at 9:58 a.m. and resumed

12 at 10:22 a.m.)

13 DR. SAMET: Okay. We are back in

14 session.

15 And we are going to move on to the

16 discussion of the charge questions. Again,

17 the way we have usually done this is with our

18 lead discussant providing their input first. 

19 We, of course, have the compilation of

20 comments.

21 Let me check, Sverre, are you on

22 the phone? Sverre Vedal, are you on the
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1 phone?

2 (No response.)

3 So, we will check if Sverre is

4 here.

5 But why don't we lead off, then,

6 John with your comments?

7 DR. BAILAR: I am not going to

8 read my comments, but, rather, hit a couple of

9 high points and expand on them some.

10 The first is that I think EPA

11 needs to revisit its definition of cause. It

12 is given here on page 1-14 as "Cause is a

13 significant effectual relationship between an

14 agent and an effect on health or public

15 welfare."

16 First, it is not clear to me what

17 you mean by significant. Does this refer to

18 the size of the effect? Does it refer to

19 statistical significance? I don't know.

20 The second is that effectual is

21 not very well-defined. The point is that I

22 would not know how to apply this definition in
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1 an unambiguous fashion. So, I ask EPA to

2 revisit that.

3 The second point I want to talk

4 about is the Hill criteria. I am concerned

5 about two things here.

6 First, I would like to say that I

7 think the discussion on a micro-level is right

8 on target with one exception I will get to in

9 a minute. It is the macro-use of these that

10 concerns me.

11 The first aspect of that is that I

12 think these should be taken in a very broad

13 way as providing a point of view or a context

14 and not a checklist.

15 The second thing is that I think

16 it is inappropriate to assign weights to

17 these, to say, for example, that consistency

18 is more important than specificity. You have

19 to look at the whole body of evidence.

20 The one thing I would like to add

21 to that is that failure to satisfy one or more

22 of the criteria can be as telling as meeting
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1 them. And I would like to see that brought

2 out as well. Again, it is important to look

3 at the whole body of evidence.

4 I might add that I heard Bradford

5 Hill himself talk about these just a very few

6 years after he published his paper in 1964,

7 and I think he would agree with both points of

8 view, that this is not a checklist and that

9 you should not assign weights or relative

10 importance to the specific items.

11 Thank you.

12 DR. SAMET: Okay. Is that it?

13 DR. BAILAR: Yes.

14 DR. SAMET: Okay. All right. 

15 Good.

16 I will say that, and maybe a

17 little history, John, for you and for the

18 others, and EPA may want to elaborate. I

19 think a lot of this text was originally

20 developed with the particulate matter ISA. 

21 And undoubtedly, it continued to be refined.

22 I think the definition of cause is
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1 a paraphrase of what is in the `64 Surgeon

2 General's Report, which sort of lapsed to

3 that. I understand your picking on it. I

4 think, actually, that is what is in the very

5 brief chapter on causation in the `64 report,

6 or something very similar, I think. And

7 perhaps, again, obviously, this issue can be

8 as tough and as deep as anybody wants to take

9 it.

10 DR. BAILAR: Well, regardless of

11 the history of this, I don't know how to use

12 that definition.

13 DR. SAMET: Okay. I think we can,

14 after we hear from the other discussants, I

15 think we can come back because I agree it

16 should be clear how it is going to be used in

17 the document.

18 Sverre is on the line.

19 Sverre, you are with us?

20 DR. VEDAL: Yes. Yes. Hi, John.

21 DR. SAMET: Hi.

22 DR. VEDAL: Can you hear me?
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1 DR. SAMET: Yes, we can hear you.

2 Why don't you go ahead?

3 DR. VEDAL: Yes. So, I don't

4 have, I think, a lot of overlap with what John

5 has said, but I do have, I guess, a little bit

6 of a different tact with the issue of

7 causation. And I don't think we need to

8 belabor this an awful lot.

9 I took exception, first, with

10 causes needing to be significant. They don't. 

11 And it is also an ambiguous term.

12 But, you know, the term just

13 effectual, as in an effectual relationship, it

14 just not very informative, and it is in some

15 sense just a little circular. So, it is

16 probably right, but it is not really useful.

17 So, I was making a pitch,

18 basically, for -- and to their credit, there

19 is some allusion to counterfactuals, but I am

20 a fan of that perspective. In this context,

21 it actually has a lot of merit just because

22 the incorporation of the notion of sort of all
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1 else being equal, which manifests itself in

2 controlled exposures, both in the toxicologic

3 experiments and the human clinical studies,

4 and then in observational studies in the

5 notion of control for confounding.

6 So, I think you can do a lot more

7 than just putting up sort of a knee-jerk

8 definition of causation. But, again, this

9 whole exercise isn't going to sink or swim on

10 the definition of causation. So, that is

11 enough on that.

12 The confounding and effect

13 modification sections, having seen previous

14 ISAs, this is a clear improvement over

15 previous discussions. There are a couple of

16 things I will elaborate on.

17 One is bringing up the notion of

18 multiple pollutants. But it is sort of

19 couched in a sort of weird sort of a

20 framework. It is has to be upfront expressed

21 in the context of confounding, that we are

22 talking about confounding by co-pollutants. 
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1 And it is not clear that that's the sort of

2 crux of the discussion there, even though it

3 is in a confounding section.

4 Again, effect modification, I

5 think there is a much better job this time as 

6 opposed to other ISAs in distinguishing it

7 from confounding. I think in the discussion

8 of it, rather than sort of launching into how

9 it differs from confounding, it is probably

10 best to define effect modification first.

11 It is interesting how temperature,

12 as an example, is sort of brought forward as

13 an example of an effect modifier, which it

14 certainly can be. But I think it would be

15 valuable to sort of compare and contrast it

16 to, just by expressing or discussing the

17 notion of temperature as a confounder, which

18 it clearly is, front and center, in the issue

19 of ozone effect.

20 The discussion of measurement

21 error, and it kind of sticks out there in the

22 middle, it should refer to the discussion, a
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1 much more detailed discussion of measurement

2 error that is in Chapter 4. I think here the

3 discussion is a little bit confusing.

4 I think the main point that should

5 be made there, and I think maybe it is

6 attempted to be made, is this notion of

7 pollutants being measured with different

8 degrees of measurement error. And when you

9 have two pollutants in a model, this notion

10 that the pollutant that is measured with less

11 error tends to dominate the effects of a

12 pollutant that is measured with more error,

13 regardless of which of the two of them

14 actually has a greater effect on health. So,

15 that is the point that needs to be made here

16 with respect to measurement error.

17 Causality determination, weighted

18 evidence, so just a small point. John touched

19 on the sort of Hill points. Just a little

20 elaboration on the coherence issue.

21 It doesn't just refer to coherence

22 across, for example, epidemiology, toxicology,
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1 clinical studies, et cetera. It also refers

2 to coherence within epidemiology, not in the

3 sense of consistency by repeated studies, but

4 across different study designs.

5 I don't really find, with all due

6 respect to Bradford Hill, and he probably

7 didn't mean it in that way, I don't find his

8 criteria all that useful, except I think the

9 notions of consistency and coherence. And I

10 think the ISA kind of brings that up, that

11 they are not sort of wedded to this framework

12 in assessing the causality, but those issues

13 are clearly part of the discussion.

14 We have been through this grade of

15 causality before. I think it is a good idea. 

16 It has worked well, certainly in the PM

17 setting reasonably well, although it has some

18 warts.

19 I like the fact, although it

20 probably has no utility, I like the fact that

21 there is now a not-likely-to-be-a-causal22 relationship category, which I don't think was
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1 present in earlier versions. It may have been

2 in one version subsequent to the PM ISA. I

3 don't know. But I kind of like that for

4 symmetry, if nothing else.

5 Under that section, there is some

6 reference to studies from the perspective of

7 the concentrations of ozone that are used. 

8 That is, studies with what concentrations are

9 going to be deemed to be relevant for this

10 causality assessment? And they throw in that

11 concentrations of an order of magnitude or two

12 orders of magnitude higher would be

13 appropriate for this. I think that is just

14 silly. And I gave an example about what path

15 that would lead us down. And I don't think

16 that is going to be meaningful in terms of

17 causality determination.

18 The section on the effects on

19 human population -- a couple of points. First

20 is the shape of the exposure response

21 relationship. I think they do actually

22 categorize sort of the issues that would tend
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1 to influence that.

2 I think one that perhaps deserves

3 a little bit more emphasis in the context of

4 ozone particularly is the measurement error

5 issue. Here we have a pollutant where,

6 arguably, you have the potential for more

7 measurement error than most of the pollutants

8 that we deal with. So, this issue of blurring

9 of a potential threshold is upfront and

10 probably a more meaningful or a more

11 concerning issue than it would be for other

12 pollutants that might exhibit less measurement

13 error.

14 It was great to see the discussion

15 of publication bias here. I thought that an

16 attempt was being made to sort of minimize the

17 impact of publication bias, but I think that

18 has been put to rest. It is not a small

19 issue, both by the work from Ross Anderson and

20 Michelle Bell, both showing, I think, clearly,

21 Michelle in the context of ozone, that

22 publication bias is at work, comparing multi-
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1 city study effects estimates from other effect

2 estimates.

3 Finally, the issue of adversity,

4 and I know this has been beat to death in some

5 settings, and it is clearly an issue in the

6 context of ozone, where we have got lung

7 function decrements, where some points can be

8 raised about adversity. Lots of markers being

9 used, and no discussion really of where these

10 markers, markers of inflammation and oxidated

11 stress, for example, where these markers fit

12 in in this discussion of adversity. So, I

13 thought it was kind of a perfunctory little

14 section in there, but it didn't really get at

15 the crux of the issues regarding adversity in

16 the context of ozone.

17 So, those are my largest

18 observations. The rest I have some small

19 points.

20 DR. SAMET: Okay. Thank you.

21 Howard?

22 DR. NEUFELD: There's not a lot
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1 left for me to say after these two. But I

2 think that the framework set up here is pretty

3 reasonable, and I don't want to belabor some

4 of the points that were made earlier.

5 I think that the scenarios laid

6 out here for evaluating causation and the

7 associations, and so on, are well-thought-out. 

8 I don't really have too many criticisms of

9 that.

10 And I think that most of the

11 points that need to be addressed in terms of

12 determining the relationships and conclusions

13 that are going to be drawn are all well14 thought-out. And the idea of dealing with

15 confounding and uncertainty and variance and

16 other sort of things are all laid out in here

17 pretty well.

18 And I think that I would emphasize

19 -- I am going to be real short here because I

20 don't want to say the same thing over -- but

21 I think that the section on the publication

22 bias is really important. It is also
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1 important in the vegetation and ecosystem

2 literature, too. If you don't get any

3 significant results, you tend not to publish

4 that. So, we tend to get a somewhat biased

5 point of view. So, there is some emphasis in

6 those fields to actually start to publish

7 those kinds of papers.

8 But I do think this sets up the

9 rest of the document here fairly well. So, I

10 will just leave at that, at that point.

11 DR. SAMET: Okay. Thank you.

12 I would just add my own comment

13 that I think, to the extent this chapter

14 really should be setting out the template for

15 the evidence evaluation process that will

16 follow it, I think as we move forward I think

17 what we should really be doing is saying,

18 well, is there evidence, in fact, that this

19 has been used and followed in summarizing the

20 evidence, in reaching conclusions.

21 I think we are saying that most of

22 this is reasonable and that there are ways
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1 that it might be improved. I think, then, the

2 real question is, has it been used throughout

3 the document in roughly the same way, given

4 the multiple authors, and so on, that are

5 contributing here.

6 I just want to flag for our

7 discussion, because it enters here the first

8 time, this sort of, I think, redefinition of

9 susceptibility that incorporates both the

10 notion of something that would change the

11 risk, given exposure, as well as the

12 likelihood of exposure.

13 I think in the past with PM we

14 were dealing with these issues of response to

15 exposure versus determinants of exposure as

16 separate phenomenon. They are now grouped

17 here in subsequent chapters. I think this

18 will need some discussion, but I am going to

19 suggest that we defer that at this point, but

20 just simply flag it because it is here.

21 And again, I think Sverre's

22 comments about the interpretation of the
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1 biomarker information are relevant. The ATS

2 document did address these issues in a fairly

3 general way. I think that document is now

4 over a decade old and may not be fully

5 reflective of all the possibilities now in

6 terms of where modern biology has taken us.

7 Other comments on this charge

8 question? Judy?

9 DR. GRAHAM: I very much like the

10 idea of having causality as a concept. I

11 think that is a major improvement from past

12 documents I have read.

13 I am concerned about two things. 

14 One is on page 110. Animal studies, animal

15 tox studies are basically dismissed. "Oh,

16 they are high; they are different." And, I

17 mean, I could dismiss them for a lot of

18 chemicals, but not for ozone. With ozone,

19 there is a congruence of animal tox, human

20 clinical, and epi. And the animal tox, the

21 effects are at low levels.

22 So, I think that, basically, this
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1 paragraph is wrong. It is factually

2 incorrect, but, then, it just sets a tone of,

3 who cares?

4 And the reason I feel strongly

5 about this is not only a personal bias because

6 I am an animal toxicologist, but the animal

7 tox provides a lot of causative information,

8 and it tells us things that humans can never

9 tell us because of the invasive procedures. 

10 So, I think this kind of sets a negative stage

11 for that.

12 The other comment I have is on

13 page 124. There is a whole subsection on

14 concepts in evaluating adversity. I know

15 that, ultimately, adversity is a determination

16 of the Administrator, but the science will

17 inform her on this. And so, when I saw this

18 title, I was really excited.

19 And, then, I read it, and it

20 didn't really say much. Like it waved a hand

21 at ATS, but, then, it didn't tell us what ATS

22 said. Now, frankly, I haven't read the ATS
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1 stuff. I read like two versions ago.

2 I mean this is the most important

3 section here, in my opinion, And so, expand

4 it some and tell us what did ATS say.

5 DR. SAMET: As it is relevant to

6 ozone.

7 DR. GRAHAM: Ozone, yes. Yes.

8 DR. SAMET: Yes, Ed?

9 MR. AVOL: Yes, I wanted to pick

10 up on, I guess, a recurring theme. This is

11 that Section 1.6.6 on adversity.

12 It is clear that, as we move

13 forward technologically speaking, we can

14 measure much more exquisite and subtle

15 changes. But what is not clear is whether it

16 is important or not biologically.

17 And so, I think, given that this

18 sort of sets the tone for the rest of the

19 document, I think we really do need to say

20 something in here about where the bar is being

21 set. And so, whether you refer to ATS and

22 explain that, or sort of define what you are
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1 going to set the threshold at, something needs

2 to be said because we can make these

3 measurements. We can measure things at very

4 low levels. We can measure biological

5 response. But we don't integrate yet -- just

6 because we measure it doesn't mean it is or

7 isn't important.

8 DR. SAMET: Fred?

9 DR. MILLER: I have two questions.

10 One is for Sverre and one is for Dr. Bailar.

11 Sverre, given that we can measure

12 ozone to the part per billion, where are you

13 coming from when you say that there's more

14 measurement error for this pollutant? Are you

15 referring to personal exposures or what? 

16 Because I was under the impression that we had

17 a very good ability to measure ozone.

18 DR. VEDAL: Yes, we have a great

19 ability to measure ozone, yes, I mean in the

20 first context, the link between ambient

21 concentrations that are used in many of the

22 studies and personal exposure.
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1 So, in ozone, I mean that is

2 probably the -- it's really the pollutant

3 where this issue is most prominent because of

4 the clear difference between indoor and

5 outdoor concentrations, the link with activity

6 levels and dose, all those things that make

7 measurement error, I think, more of an issue

8 for ozone than, arguably, any other pollutant.

9 DR. MILLER: Okay. Thank you.

10 And, then, Dr. Bailar, I wondered

11 if you could expand on your comment about

12 specificity, in particular, when you mentioned

13 about multiple causes being possibly involved. 

14 Because, to me, I think this goes to

15 addressing the point collectively of the

16 cascade of events that may be occurring. They

17 clearly, in my mind, do not involve a single

18 mechanism. So, I thought you were right on

19 there, but I am wanting to make sure I

20 understand what you are getting at.

21 DR. BAILAR: This refers, I think,

22 to my written note rather than what I said. 
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1 Because this was more addressed to EPA at a

2 very specific level, and I thought they could

3 check on this and be sure.

4 It is my understanding that

5 specificity in Hill's original criteria

6 referred to a single cause having multiple

7 effects. He thought it was unlikely

8 biologically that a single cause could have a

9 lot of unrelated effects on birth outcome and

10 pulmonary function in adult life and cancer

11 incidence, and so forth. He said his feeling

12 was that, if you had one effect that had all

13 -- I'm sorry -- one cause that seemed to have

14 all those effects, it was more likely to be

15 due to bias.

16 The way I interpret this document,

17 they are looking at it the other way around. 

18 Are there a lot of causes for a single effect? 

19 And if you limit yourself to where there is

20 only a single cause or a single major cause,

21 I think that is really very restrictive, and

22 I wouldn't want to go along with that.
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1 DR. VEDAL: So, John, this is

2 Sverre.

3 I thought they had it right, but I

4 need to go back there again. Let's see. Yes,

5 let's see. Yes, I mean, what they say, "As

6 originally intended, this refers to increased

7 inference of causality if one cause is

8 associated with a single effect or disease."

9 I see where you are. "So, this is

10 now considered one of the weaker guidelines

11 for causality. For example, many agents cause

12 respiratory disease."

13 Yes, I think -- so your point is a

14 good one.

15 DR. SAMET: Okay. Other

16 questions? Joe?

17 DR. BRAIN: Yes, I have one other

18 comment about the causality assessment

19 template, as you call it, Jon.

20 I guess the big question is, does

21 ozone cause health and environmental outcomes? 

22 But I guess my question is, in terms of
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1 causality, which ozone? Is it ozone per se or

2 is it the increment of ozone produced by what

3 humans do? Is it the difference between

4 ambient ozone and baseline ozone?

5 And it seems to me that is really

6 an important question as we think about

7 causality. As we look for to what extent

8 ozone causes diseases, environmental

9 consequences, are we concentrating on the

10 increment we are responsible for or are we

11 just looking at ozone per se? I think that is

12 an issue that we will have to struggle with

13 throughout the document.

14 DR. SAMET: I think that is almost

15 a risk-of-exposure analysis issue as you

16 phrased it. I am sure we will be discussing

17 that. Is that fair?

18 Let me check, those on the phone,

19 other comments on this? Who else is on the

20 phone right now besides Sverre?

21 DR. FREY: This is Chris Frey.

22 DR. WEATHERS: Kathy.
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1 DR. SAMET: Chris and Kathy, do

2 you guys have any comments? I just don't want

3 to forget you.

4 DR. WEATHERS: No additional ones

5 for me.

6 DR. SAMET: Okay. Anything else

7 on charge question 2?

8 (No response.)

9 So, what we are going to do is ask

10 one of our members of the commenters to sort

11 of draft up a summary response, John, and I am

12 going to offer you that as a part of being a

13 victim of the alphabet.

14 (Laughter.)

15 But, Sverre, you are not

16 forgotten.

17 (Laughter.)

18 So, if you could, I think, look at

19 compiling a draft response to this from the

20 comments of your colleagues, anything you

21 heard here that you feel needs to be

22 incorporated? And these don't need to be
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1 particularly lengthy.

2 (Off the record comments.)

3 DR. SAMET: Okay. Then, we will

4 leave question 2 and go to question 4. Ted?

5 DR. RUSSELL: Okay. On Chapter 3,

6 this has to do with the atmospheric chemistry,

7 physics, and characterization of the

8 spatial/temporal ozone levels.

9 My first read of the chapter,

10 actually, you know, it basically was

11 appropriate. I thought it did its job pretty

12 well. And when I went through the question,

13 for the most part, at first brush, I would say

14 yes.

15 And, then, I started thinking down

16 the road. There may be one general area that

17 I think requires more work. And that has to

18 do with, if you start thinking about where we

19 might end up in this process, we may be

20 talking about an ozone standard of 60 to 70

21 parts per billion again.

22 And, then, we are also talking
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1 about PRB levels that are not that much lower

2 than the 60 and are expected to increase with

3 time. And that is something that I think is

4 important here, is that, with time, background

5 ozone levels are going to be increasing. So,

6 it is going to become an increasing issue.

7 So, my major concern after reading

8 this was I think the chapter needs to do a

9 more thorough job of looking at the lower

10 ozone levels. Let's say the 20 to 60 part per

11 billion levels. Again, if we are looking at

12 a no-threshold response to ozone in linear

13 whatever, what is happening at those low

14 levels becomes just as important as what is

15 happening at the high levels because, in fact,

16 we are spending more time at the lower levels. 

17 So, I just think we need to characterize those

18 more than we currently are.

19 So, in response to some of the

20 questions, if we go to sub-question -- you

21 know, for the most part, my answers are yes,

22 but with a caveat: needing to look more at
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1 the lower levels.

2 So, in response to 4A, again, I

3 think the discussion on the measurement of

4 ozone and its components is fine. That is

5 something that we have been doing for a long

6 time, and we do it well, for the locations

7 where we have monitors.

8 And, then, for the spatial and

9 temporal patterns, in terms of what is

10 happening at the higher end in looking at the

11 temporal and spatial trends, it was fine, but

12 I think we need to know more about what is

13 happening at the lower ends to see how they

14 are going to respond to controls.

15 Luckily, Table 3-6 provides some

16 evidence there that our current controls

17 aren't doing that much at the lower end, but

18 it would still be nice to have more analysis

19 of that, just because if there is going to be

20 some response to controls at the lower end,

21 those should be considered.

22 When looking at the PRB, I am one
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1 of those who thinks that the modeling approach

2 is the appropriate way to address the PRB

3 because I think you cannot directly measure

4 it, given all the issues that have been

5 discussed and are adequately discussed in the

6 document.

7 Though, I think my real concern

8 here is how you are going to mix and match

9 modeled quantities and measured quantities. 

10 And if you look at the modeling, there are

11 areas where you can find high biases and low

12 biases, which isn't surprising. And, overall,

13 I would say that they have adequately shown

14 that the model is generally working well, but

15 you have got these biases that ultimately you

16 have to do something with. And I think that

17 is something that you need to address within

18 part of the ISA, is to provide the scientific

19 background about how you are going to do it.

20 I personally think that the model

21 is probably doing better on the anthropogenic

22 ozone impact. So, I would probably look to
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1 see how you can use that information within

2 the model, but, then, there is a problem of

3 scale. Even when they go down to the finer

4 scales, still you are not going to be able

5 capture the really highest levels associated

6 with urban plumes.

7 So, it is going to be a tough one. 

8 And I think you just have to lay out how you

9 are going to do it, provide the evidence, and

10 address what sort of uncertainties and biases

11 will also still be there.

12 Sub-question C, for the most part,

13 it does address what is happening with the

14 seasonal and urban and diurnal patterns. But,

15 again, maybe not so much the low end, and,

16 actually, not so much in the non-urban

17 locations. Much more is specific to the urban

18 locations.

19 If we start looking at what the

20 use of the information here for the W-126 or

21 the welfare standard, I think more has to come

22 out and show what has been happening
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1 temporally with the W-126 standard and what

2 would likely happen at the low ends with more

3 controls.

4 And in sub-question D, I think the

5 emphasis on ozone is appropriate and the

6 discussion on other pollutants is adequate.

7 DR. SAMET: Okay. Thank you.

8 George?

9 MR. ALLEN: Thanks.

10 First of all, I would like to

11 acknowledge the staff. They did a pretty good

12 job in writing this section. It is a pretty

13 big section and there is a lot of work, there

14 is a lot of components to it.

15 I think in Section A, certainly,

16 measuring ozone is not hard. That is the good

17 news. We have a lot of sites nationwide

18 ongoing, long-term. That is the other good

19 news.

20 But when you get down to the urban

21 scale and trying to look at gradients within

22 an urban area, we often don't have much
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1 information. In my own backyard, Boston, for

2 example, if you look at the core urban area,

3 there is only one ozone monitor, and it is an

4 ozone hole. But if you go five miles away,

5 the levels are very different. We have a

6 station in Lynn, which is about 12 miles

7 downwind. It is very different.

8 In the REA part, I show some

9 associations. In fact, I am getting ahead of

10 myself. But the correlation can be often

11 pretty good, but there's actually an offset

12 which is due to the local titration effect.

13 So, in terms of, you know, if it

14 is a large urban area where you are really

15 looking at your own stuff, the patterns might

16 be different. So, LA is not Atlanta is not

17 New York is not Boston. Each urban area does

18 behave differently.

19 And, in general, most of these

20 urban areas don't have a lot of ozone

21 monitors. So, the spatial issue is

22 complicated.
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1 We have a decent amount of rural

2 ozone monitors, and I think we are going to

3 get more soon. And there, of course, the

4 spatial patterns, at least horizontally,

5 aren't that large. Of course, if you go

6 vertically, it is a different story.

7 PRB really is, I think, the

8 gorilla on the block here for a lot of what we

9 are going to be talking about. And I think

10 here the ISA on Chapter 3 probably could do a

11 better job of explaining the process, not only

12 how/why, but making a distinction between

13 direct stratospheric and intrusion events,

14 which I give a couple of examples from at Mt.

15 Washington, versus the overall contribution as

16 described in the Thompson paper from 2007,

17 which is what probably really matters.

18 In essence, what happens is you

19 can have the actual events themselves, it is

20 a wave propagation, and they are only two to

21 three hours in duration. But you are

22 injecting stratospheric ozone into the
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1 troposphere, which then gets mixed around and

2 can become a multi-day timescale process, at

3 much lower levels. I think there could

4 probably be a better discussion of that.

5 Let me see. I am getting out of

6 order here. I will come back to that in a

7 bit.

8 One issue that does get into

9 measurement effects is the concern about wood

10 smoke and the ozone. Certainly, that is a

11 national-scale problem. In the Eastern U.S.

12 it is more wildfires transport from either

13 Ted's part of the country or up north in

14 Canada. And ozone is often associated with

15 these events, and it is usually considered to

16 be the fact that you are injecting a lot of

17 VOCs into the atmosphere.

18 But there is the possibility

19 -- this does need to be sorted out -- that

20 there may be some interference from mercury. 

21 There certainly is mercury associated with

22 forest fires, at least in the Eastern U.S.,
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1 where you have substantial deposition of

2 mercury. And, actually, I think Hopke just

3 put out a paper assessing some of those

4 emissions.

5 And mercury is a very, very potent

6 interference, as noted in Chapter 3, on the UV

7 ozone analyzers that are used. So, it would

8 be useful to sort out when it comes to forest

9 fire contribution, which presumably is natural

10 background, how much of that is real and how

11 much of that is actually driven by mercury

12 interference.

13 On page 3-31, they did not

14 consider using carbon monoxide as a

15 reasonably-conserved tracer, at least at this

16 timescale, for urban air masses. It would

17 seem, in the context of that discussion, lines

18 20 to 24, that that would make some sense

19 there.

20 Also, on page 3-31, there is a

21 very large dataset that seems to have been

22 overlooked, possibly because it is not in AQS. 
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1 It was a 10-year research-grade ozone hourly

2 dataset at the summit of Mt. Washington,

3 northern New Hampshire, just about 2

4 kilometers elevation, 6300 feet, and pretty

5 much a probe into the troposphere.

6 And I think there is an awful lot

7 of information to be mined there. It was part

8 of the Air Map Program out of UNH. I show a

9 couple of examples of some smoothed and events

10 in my comments. But I would hope that would

11 be included as an eastern site in this process

12 of the PRB.

13 And I talked with Daniel about

14 this, and he said he might -- and you can nod

15 or shake your head -- might be able to do some

16 additional GEOS-Chem modeling up at that

17 elevation, because you don't go that high in

18 your runs normally.

19 But we had an event, direct20 intrusion event in `03, in the spring of `03

21 -- they are all in the spring -- in the spring

22 of `03 and the spring of `08. And those are
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1 the only two clear events, you know, real

2 hits, over a 10-year period. And they lasted

3 two to three hours.

4 So, I think there is a really

5 useful dataset there, in part because of the

6 duration, in part because there aren't many

7 high elevations in the sites in the East. In

8 fact, in all of the high-elevation sites in

9 the document, none of them are in the East.

10 And there are some sites. There's

11 Mt. Mitchell. There's the Shenandoah National

12 Park and the Mt. Washington and Whiteface. 

13 But, of all those, Mt. Washington is probably

14 the least -- there is no influence of local

15 sources at that site. You might occasionally

16 have titration from the local generator that

17 they generate their power with, the diesel

18 generator there, but that is a downward spike,

19 not an upward spike.

20 So, it ought to be easy to model

21 the GEOS-Chem because the spatial scale is

22 huge. And it might be helpful not only to see
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1 it -- well, basically, to see how well

2 GEOS-Chem can do that, because it ought to

3 work fairly well. I don't expect you to be

4 able to those three-hour spikes of intrusion. 

5 That is asking too much. But, certainly, the

6 patterns, and there are clear spring peaks,

7 which is consistent with what others have seen

8 in that dataset. So, Shenandoah, Mt.

9 Washington, maybe Mt. Mitchell, these are all

10 eastern sites that might be worth including.

11 Let's see, what else? Section

12 3.5.2, there are a number of plots there, but

13 they are a little hard to look at. It would

14 be more useful perhaps to plot the 95th

15 percentiles along with the other information.

16 I certainly agree on monitoring

17 methods both the specifications in The Federal

18 Register for ozone FRMs and the FRM itself are

19 seriously outdated, and ORD needs to do the

20 right thing in this round and, as they did

21 with SO2, revise the ozone FRM. NO

22 chemiluminescence would be a good choice. It
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1 is robust. It doesn't use the ethylene, and

2 so on and so forth.

3 The FEM is pretty good. Again,

4 the specifications are outdated. They can do

5 a lot better than what is required in The

6 Federal Register, and those should be

7 tightened up.

8 There certainly are questions

9 about interferences with the FEM. I think

10 they are rare. I don't think they really

11 contribute to what we are talking about here. 

12 They are moisture-related. There are fixes,

13 and maybe that could also be done in the next

14 round of the regulations, to deal with some of

15 the transient events that are due to rapid

16 moisture changes on the UV FEM.

17 A correction to Section 3.5.6.1,

18 page 3-52, line 23: the NCore sites, the

19 parameters got a little skewed there. Ammonia

20 and nitrate acid are not measured at the NCore

21 sites, but SO2 is. So, for whatever that is

22 worth, just a correction there, a technical
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1 one.

2 Also, on the same page, the FEM

3 sites measure NOy, at least they are supposed

4 to, although, generally, it is a fuzzy

5 measurement because it has not been using

6 research-grade NOy techniques. So, it is

7 really more "NOwhat" But, hopefully, that

8 will change over the near future.

9 Urban spatial scale, as I said,

10 just, again, knowing my own backyard, and that

11 Boston was one of the focused studies last

12 time around and may or may not be this time

13 around, it is worth knowing that one of the

14 sites, Blue Hill, 10 miles south of Boston, is

15 actually an elevated site, high relative to

16 the rest of Boston. It is only about 630

17 feet, but it does behave very differently much

18 of the time.

19 So, if you are trying to integrate

20 over the urban area for Boston, you need to be

21 aware that some of these sites are not at

22 ground -- what we would consider ground level. 
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1 And although 630 feet doesn't sound like much,

2 certainly in the West, in Metro Boston it is

3 a lot. And it is often above the mixing

4 height in the early mid-part of the day.

5 It is not run year-round, however,

6 and that might be worth something, a site like

7 that might be worth running year-round. There

8 are two sites in Boston that do run year9 round, the downtown and the one in Lynn 12

10 miles to the northeast.

11 As I said earlier, the Boston CSA

12 is very large. It includes part of Rhode

13 Island and New Hampshire. And if you are

14 trying to do health effects at that scale,

15 that might be problematic.

16 As has been noted earlier,

17 exposure misclassification has a huge effect

18 when you try to assess the actual effects, the

19 beta of the effect, as seen in the comparison

20 between the ACS studies for PM and the six21 city study for PM, where the difference was

22 six cities took a neighborhood, you know, a
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1 radius of a few miles, where ACS took the

2 entire Metro CSA, or whatever you want to call

3 it, and got different effects because the

4 exposure misclassification was much larger.

5 Some minor points on page 385,

6 line 11, which sites are A and D for Boston? 

7 It is just not clear.

8 Some of the plots on page 396,

9 Figure 343, it would be useful to have similar

10 plots with weekend and weekdays separated out. 

11 And for that matter, even Mondays versus

12 Fridays because there tends to be a pattern

13 where things build up during the week.

14 One final general comment on the

15 concept of other data that may be useful to

16 incorporate. It is below most people's radar,

17 but the Canadian Government -- it is finally

18 out now -- although it is not readily

19 available, the Canadian Smog Science

20 Assessment from Environment Canada and Health

21 Canada. I am familiar with it because I did

22 some of the review on it. It is available if
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1 you request it.

2 And there are two chapters that

3 are probably very relevant to this discussion,

4 especially in terms of PRB, Chapter 3 on

5 "Ambient Measurements and Observations" and,

6 then, Chapter 7, "Air Quality at

7 Regional/Local Scales".

8 So, I would encourage EPA to

9 obtain that document. And if there are any

10 questions on getting it, you can talk to me. 

11 And to the extent that it is relevant to this

12 process, incorporate it. But I think there is

13 a lot of information there that may be quite

14 useful.

15 Thanks.

16 DR. SAMET: Okay. Daniel?

17 DR. JACOB: Okay. So, following

18 up on Ted and George, overall, I thought this

19 was a very good chapter, very informative, and

20 I have a bunch of specific comments sprinkled

21 through the chapter. I won't go through them

22 here.
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1 What I would like to make here is

2 four general comments about what George

3 appropriately described as a gorilla in this

4 chapter, which is a specification of the PRB. 

5 And here, in the interest of disclosure, the

6 PRB ozone values that are shown in this

7 chapter and the ones that are expected to be

8 used in this ISA come from my group. So, I am

9 not going to talk about how good they are.

10 (Laughter.)

11 But I will say that they are

12 represented in the chapter, from what I

13 consider -- I had nothing to do with writing

14 the chapter -- that they are presented very

15 fairly. And, in particular, talking about the

16 issue that Allen raised, that they make a good

17 point about showing the variability in the PRB

18 in the model, and how it captures the

19 variability in the observations, at least on

20 a daily timescale.

21 Okay. So, I have four general

22 comments to make. The first one is about the
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1 integration of modeling observations. The

2 second one is about chemical uncertainties. 

3 The third one is about the difficulty of

4 dealing with extremes, and the fourth one is

5 about current and projected trends. This is

6 what I am going to touch on.

7 The first thing about integrating

8 modeling observations, I think that there is

9 a false debate going on here because Ted

10 pointed out the PRB has to be a model

11 quantity. There is no way around it. You

12 know, Trinidad Head doesn't measure the PRB,

13 if only because of the North American

14 contribution to background hemispheric

15 pollution.

16 So, it has to be a model

17 construct, but, at the same time, it is very

18 important to look at the data from Trinidad

19 Head and some of the other background sites

20 that Allen and Sam talked about, and test the

21 models with those baseline sites because they

22 have concentrations and variability that are
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1 highly relevant to the ability of the model to

2 simulate the PRB.

3 So, in other words, I don't think

4 there should be any kind of debate about

5 whether we should use the model versus

6 observational approach to PRB. The two have

7 to work together. The PRB has to come from a

8 model. The models have to be extensively

9 evaluated, tested, and, if necessary,

10 falsified with observations.

11 The second point I want to make is

12 about chemical uncertainties. There I think

13 that the chapter could do perhaps a little

14 better job. There are, in my view, three

15 major areas of uncertainty that could affect

16 the PRB calculations.

17 The first one is the effect of

18 halogen chemistry, which is a debate, an

19 intense debate right now, going on in the

20 literature. The chapter talks about it in

21 terms of affecting urban ozone, but it would

22 also affect background ozone, due to sources,
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1 in particular, roaming radicals that are

2 widely distributed in the free troposphere. 

3 And this could actually bring down the PRB

4 values by maybe, I don't know, 3 to 5 ppb,

5 depending on who you believe right now. The

6 science is in flux.

7 A second large area of uncertainty

8 where the science is very much in flux is the

9 whole business of isoprene chemistry. It is

10 very clear that representation of isoprene

11 chemistry in models under low NOx conditions

12 is wrong. It is just plain wrong.

13 And we really don't know what the

14 impacts are for ozone. Again, this is

15 something where there is some literature out

16 there that could be referenced in the chapter

17 and more work will be coming out over the next

18 couple of years.

19 The last point with regard to

20 chemical uncertainties I would like to raise

21 has to do with ozone production in fire

22 plumes. And here, there is a lot of confusion
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1 right now in the scientific community. In

2 general, we think, based on our models and

3 based on aircraft campaigns, of which I have

4 been part, that fire plumes don't make ozone,

5 at least at mid-latitudes in the boreal zone.

6 And that is because all the NOx gets converted

7 to PM and that is the end of it.

8 But, of course, PM eventually

9 decomposes to produce NOx, and, then, that

10 will eventually make ozone with a very high

11 production efficiency. And we have

12 observations in the Western United States that

13 show elevated ozone clearly associated with

14 fires. So, here this is something really that

15 we need to understand because wildfires and

16 even prescribed fires are presently considered

17 to be part of a PRB.

18 My third point has to do with the

19 difficulty of simulating extremes. And here

20 I would consider both extremes in the

21 frequency distribution at a given site and,

22 also, extreme sites.
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1 So, the first point with regard to

2 extreme and frequency at a given site, models

3 cannot simulate 100 ppb of ozone at

4 Yellowstone. No, they can't.

5 And there's a number of reasons

6 why they can't that have to do with numerical

7 diffusion in the models, even when you use

8 high-order advection algorithms, that have to

9 do with your ability to specify the temporal

10 variability of these sources.

11 There's a number of factors. 

12 Okay, so what that means, now these are

13 really, really the very high extremes. What

14 we find is that we can reproduce ozone quite

15 well up to a very high percentile, 95th

16 percentile, 98th percentile, up to about 75

17 parts per billion at very remote sites.

18 And, then, you have these spikes. 

19 And those spikes, well, you know, the model

20 can't do it. So, does that mean that you

21 throw away the model? Well, of course not;

22 that's silly.
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1 What that means is that you have

2 got to deal with those extremes in a different

3 way. And we have the tools to deal with

4 extreme events. We can use satellite data to

5 observe the structure of exchange events. We

6 can look at occurrences of fires, and so on. 

7 We have tools for this. So, I don't think

8 that the debate should be distracted by this.

9 The other point about extreme is

10 extreme sites. We spend a lot of time, when

11 we discuss PRB, talking about mountain sites. 

12 Oh, stratospheric exchange influencing a

13 mountain side, and so on. Those are

14 interesting to look at in models. I think we

15 should consider the fact that nobody lives

16 there.

17 And so, if we are going to use a

18 PRB concentration with reference to public

19 health effects, well, you know, is Gothic,

20 Colorado really relevant? Clearly, there

21 there's going to be elevated PRB. The models

22 can capture that. They can't capture the high
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1 extremes. Should we hang the whole debate on

2 a PRB condition that is really irrelevant to

3 most of the country and certainly everywhere

4 where people live?

5 Okay. Finally, I would like to

6 make a point about long-term trends, both

7 observed trends and projected trends. And

8 here, you know, the chapter talks about

9 trends, about present trends. It could do a

10 little better job because, interestingly,

11 while we have an overall downward ozone trend

12 in this country, the background, the trend,

13 the background as might be relevant to the PRB

14 -- notice I don't use PRB; I use background --

15 the trend is on the rise. And we see this

16 from sites on the West Coast. We see this in

17 air over the Pacific. We see this at many of

18 our national parks.

19 And it is interesting to wonder

20 whether that is relevant to the PRB. 

21 Presumably, it is. But the models cannot

22 capture properly these trends. And this is,
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1 again, something that we need to address.

2 You might say, well, you know, of

3 course, background should increase because of 

4 Asian pollution. Well, you know, yes, but,

5 according to our models, Asian pollution

6 doesn't contribute that much to the

7 background. And the trend in Asian sources

8 has not contributed that much to an increase

9 in the background.

10 My own bet is increasing frequency

11 of wildfires, but this is something that is

12 debated in the literature. The point is that

13 there are trends, in particular, shown in the

14 work by Dan Jaffe and Dave Parrish, and that

15 should be recognized.

16 With regard to projections for the

17 future, here the chapter doesn't really say

18 anything at all. It might try to say

19 something.

20 There is a general perception

21 that, of course, the background is going to

22 increase in the future because everywhere
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1 except North America people are increasing

2 their emissions. Well, that is not

3 necessarily true. And China is starting to

4 implement some pretty aggressive controls.

5 Interestingly, if you look at the

6 projected global trends in emissions of air7 quality-relevant gases from the latest IPCC --

8 that is the one that will be out in 2014, the

9 AR5 -- what they show is all these emissions

10 going down in the future. Okay? The NOx

11 going down, VOCs going down, way down, SO2,

12 like a rock. Methane, flat.

13 Well, the point is that now there

14 is a lot of debate as to whether those are

15 good projections for the future. They assume

16 a pretty aggressive policy, in particular, in

17 developing countries in controlling pollutant

18 emissions. But there is a lot of debate going

19 on about whether we can expect the background

20 to go up or to go down.

21 Then, there is also the effect of

22 climate change. On one hand, one would expect
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1 climate change to bring down PRB values, just

2 because of having higher water vapor in the

3 atmosphere and, therefore, more chemical loss. 

4 But, at the same time, if climate change means

5 more frequent and larger wildfires, as there

6 is pretty good evidence for that, then that

7 could bring PRB up.

8 So, all this could be

9 described/discussed a little bit more in the

10 chapter.

11 That's it. Thank you.

12 DR. SAMET: Okay. Thank you.

13 So, you all three liked the

14 chapter, but had an awful lot of comments.

15 (Laughter.)

16 Let me see if others want to

17 comment. And, clearly, the PRB issue is going

18 to be a critical one in further steps in this

19 process.

20 Michelle?

21 DR. BELL: I thought this chapter

22 had a lot of really useful information. I
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1 enjoyed it, but I think it is quite poorly2 integrated with the rest of the document. But

3 this is something that can be fixed. I will

4 just give you an example.

5 So, if you read the document

6 towards the back, you run into this primer on

7 air quality modeling, which incorporates a lot

8 of scientific evidence, you know, chemical and

9 physical transformation of pollutants. It is

10 an incredibly-useful tool to gain more

11 scientific evidence, but the air quality model

12 is not scientific evidence itself.

13 And so, when reading through this,

14 I found it quite odd that we have pages and

15 pages about this, but it is out of balance

16 with the rest of the document. Like we don't

17 have pages about to deal with to design a

18 chamber study or how do you pick a reference

19 period for a case crossover model, and so on.

20 I mean I think there is a good

21 rationale for why this is in here. 

22 Particularly, I am looking at the background
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1 levels. But if you look at like how Section

2 2.3 opens up, it is just very general. So, I

3 think talking about why is air quality

4 modeling so heavily emphasized in the document

5 is going to be really useful for helping

6 people read it, so that it doesn't just become

7 a primer about air quality modeling, just for

8 the sake of understanding this state-of-the9 science tool, but we may want to talk about

10 this later because you are going to use it

11 later. So, this is kind of out of sequence

12 and unbalanced.

13 And my other point I would like to

14 make is that I think that this section would

15 benefit tremendously from more information on

16 the evaluation of air quality modeling, which

17 is really missing from most of the document. 

18 I mean you have figure after figure, you have

19 over a dozen figures comparing the GEOS-Chem

20 model ozone to the absorbed values.

21 But what would be better would be

22 like a synthesis of the overall quality of the
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1 models in terms of what does it measure well

2 and what does it not. And this really gets to

3 some of the other points that were made, like

4 we really care about how well it estimates low

5 levels. So, that may be more important in

6 some context than getting like the one-hour

7 peak on a given day, and things of that

8 nature.

9 So, I think that tables or a

10 section that kind of synthesized the overall

11 model evaluation of CMAC, where does it do

12 well, where does it not, what are some of the

13 limitations, the isoprene chemistry, the

14 biogenic emissions, and so on, would be really

15 useful.

16 DR. SAMET: Okay. Other comments? 

17 Anybody on the phone?

18 DR. WEATHERS: Yes, Jon, this is

19 Kathy Weathers.

20 DR. SAMET: Yes, Kathy?

21 DR. WEATHERS: I would to support

22 that as well, and what Daniel and Ted said. 
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1 I think it is incredibly important that the

2 evidence and rationale for evaluation of the

3 model be presented and I'll underscore as well

4 what Michelle said. Based on the CASAC

5 NOx/SOx process, it will just be critically

6 important to lay all of that out upfront.

7 DR. SAMET: Okay. Fred?

8 DR. MILLER: I was disappointed in

9 the Section 3.4 because there is no bottom

10 line. Everywhere else in the document, this

11 is suggestive of causality. This is

12 causative. This is so and so.

13 This gorilla, as it's been

14 described, is just left hanging there. And I

15 don't have a sense, if you are punting to

16 OAQPS, and having read OAQPS's plan, they are

17 punting to the future. I think this is such

18 an important topic that it has got to be laid

19 out here more as definitive options.

20 As for example, the 12 cities that

21 are talked about in the health plan, it would

22 be great to take at least a couple of those
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1 and see the different methods that are

2 discussed here relative to the PRB. What are

3 the values that end up in these cities? 

4 Because those are the ones that are going to

5 be in the risk assessment.

6 And by the way, I am from Wyoming,

7 and we don't like to let a lot of people in.

8 (Laughter.)

9 But several million a year go to

10 Yellowstone. Okay? So, you may not live

11 there, but you visit a lot.

12 So, this whole concept of the PRB

13 I think has got to be treated more and come to

14 some bottom line as far as the direction

15 because, for me, it just was lacking.

16 DR. SAMET: John, do you want to

17 comment on this point that Fred raises? I

18 mean, where does the bottom line on PRB come

19 in in the process?

20 DR. DUTTON: I will just add in

21 the second draft ISA -- Steve Dutton, EPA --

22 in the second draft ISA, as Jim alluded to, we
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1 are doing some additional modeling work. And

2 that will address a lot of the questions that

3 Michelle brought up and as well as yourself,

4 with the model evaluation at different urban

5 and rural locations and, also, addressing some

6 of the uncertainties in the model and

7 characterizing more fully some of the PRB

8 estimates that come out of that.

9 So, we are working on that right

10 now, getting preliminary results in. You will

11 have a chance to look at that in the second

12 draft.

13 DR. SAMET: I wonder, as a general

14 point, if it would be useful when we get,

15 let's say, a first draft, if we had perhaps

16 some placeholders and something as to what is 

17 not there. I think that would probably be

18 helpful to us. I think, then, it would save

19 some questions and pondering and maybe you

20 might be a little less flagellated. So, think

21 about that.

22 Joe?
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1 DR. BRAIN: I have an adjacent

2 comment. Again, I kept looking, you know,

3 well, what is the PRB value? And that relates

4 to integrating into other chapters, as we look

5 at the epidemiology, as we look, you know, for

6 a particular study, what is an appropriate PRB

7 value.

8 And then I guess maybe this goes

9 beyond our Committee, but, as I understand it,

10 the PRB excludes human contributions as long

11 as it is outside of North America. And is

12 that really appropriate, given the fact that

13 we have exported metal mining, smelting,

14 manufacturing to China? It is not as though

15 we are not, to some extent, responsible for

16 the PRB that enters the country, but maybe

17 that goes beyond our purview.

18 But I agree, I think it really is

19 the elephant in the room, given the magnitude

20 of the PRB and how close it sometimes is to

21 the .6, .7, .8 that we are worried about.

22 DR. SAMET: Okay. Anybody else? 
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1 Chris? Let me just check on the phone.

2 DR. FREY: I don't have anything

3 to add.

4 DR. SAMET: Okay. Ed?

5 MR. AVOL: Two comments. One,

6 just to pick up more generically with what

7 Fred alluded to, and that is sort of what I

8 found missing from this was just a general

9 integrated summary of what the point of all

10 the presentations were in this chapter. It

11 just sort of ends. And so, it would be

12 helpful to sort of say, you know, bring to the

13 end what you think are the key elements of

14 this.

15 And, then, secondly, Section 3.6.4

16 and the association with the co-pollutants, I

17 especially appreciate that. As we move more

18 to thinking about multi-pollutant exposures,

19 I think it is important to think about how

20 they interact and what the importance of them

21 is in the ambient atmosphere.

22 In the case of ozone, of course,
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1 it sort of behaves as a different sort of

2 creature compared to, say, the traffic-related

3 emissions. But it still is good -- I think

4 the plots and so forth were great to see. I

5 think they are very useful, and I think you

6 ought to say something about that, expand on

7 that piece.

8 DR. SAMET: David?

9 DR. CHOCK: Yes, I find Table 3-1

10 and Table 3-2 to be very helpful. These

11 tables refer to seasonal means, daily max,

12 eight-hour ozone concentration. And the sites

13 listed are definitely not PRB sites.

14 But the important thing is that

15 one is on the seasonal means, and Table 3-2 is

16 on the seasonal maximums. And if we are

17 talking about the fourth highest in three

18 years, then we ought to emphasize the extreme

19 maximum.

20 So, maybe I would recommend that

21 EPA would do a table perhaps that shows what

22 the fourth highest value in three years would
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1 look like for these sites, even though they

2 are not PRB sites. But they may be a preview

3 in case we one day actually would be able to 

4 meet those concentrations.

5 DR. SAMET: Okay. Anyone else? 

6 Okay, Ted?

7 DR. RUSSELL: I want to point out

8 that George Allen comes earlier in the

9 alphabet on this one.

10 (Laughter.)

11 DR. SAMET: Thank you for pointing

12 that out. Thank you for pointing that out,

13 Ted, but that was not the question.

14 (Laughter.)

15 Would you?

16 DR. RUSSELL: Yes.

17 DR. SAMET: Thanks.

18 MR. ALLEN: Ted, we'll help, okay?

19 DR. SAMET: You, of course, are

20 going to enlist help from your colleagues, and

21 nobody escapes.

22 Let's move on to environmental
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1 effects. Kathy?

2 DR. WEATHERS: Sure. I think the

3 advantage of this chapter is that it builds

4 upon a lot of past work. The disadvantage is

5 that there hasn't been a tremendous amount of

6 new work since 2006, the space studies

7 notwithstanding and the meta-analyses

8 notwithstanding.

9 I have some general comments that

10 I will offer. And looking at my colleagues'

11 reviews, it looks like there are some very

12 specific ones as well.

13 In answer to the question, have

14 the major effects been characterized, I think

15 that the answer to that is yes, especially for

16 plants and looking at mechanisms, but it

17 appears that there are some errors as well in

18 some of the literature review and the analyses

19 that, again, my colleagues have pointed out. 

20 And there is some confusion in parts about

21 indirect and direct effects.

22 The integration question, I think
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1 that that could be done a little bit better

2 than it has been done from, quote, "scales",

3 going from issues to ecosystems. I have made

4 a couple of specific suggestions about how

5 that might be done. And I think that there

6 are some conceptual pieces and syntheses that

7 might be done to indicate where some of these

8 scales are connected and where some of the

9 effects of the ozone are connected from plant

10 to ecosystem. So, there is some better

11 synthesis that I think can be done.

12 The chapter is quite extensive,

13 and it has been pointed out that it is

14 redundant with earlier chapters. It certainly

15 could be condensed and better integrated. I

16 wasn't particularly bothered by its length,

17 but it certainly could be.

18 Let's see. I think those are the

19 major comments I had.

20 What seems to be missing is the

21 literature on lichens and bryophytes, which

22 one of my colleagues has pointed out is quite
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1 extensive, and it doesn't appear in this

2 chapter.

3 So, I will pass it on to my

4 colleague.

5 DR. SAMET: Okay. Thanks.

6 Dave?

7 DR. GRANTZ: Well, first of all, I

8 want to say that I think this was a tremendous

9 amount of work and a very nice job. There is

10 a lot of vertical integration. I thought all

11 the questions got a short answer of, yes, they

12 did a very good job.

13 I also want to say that I agree

14 with the conclusions of causality in Table

15 9-1. I think that was pretty nicely done.

16 And, then, I want to make a few

17 points that sort of highlight things that are

18 in my written comments. I think it is very

19 important that we come back to this question

20 of open-top chamber versus non-chambered

21 exposures for vegetation. The ISA does a very

22 god job of repeating the conclusion that all,
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1 or virtually all, of the recent work confirms

2 what we knew from open-top chambers.

3 That is important because it has

4 been a point of contention. It has been a

5 point of criticism of what we know about ozone

6 effects, welfare effects, and I think we can

7 lay that to rest. I think the ISA does a very

8 nice job of doing that.

9 Now, having said that, there is a

10 question whether it is appropriate to use the

11 exposure response relationships from the NCLAN

12 studies. I think one thing that needs to be 

13 put in the ISA is that current crop cultivars

14 in places with high ozone exposure tend to be

15 less sensitive than the crops that were in

16 existence at the time of the NCLAN studies.

17 So, to some extent, those exposure

18 response relationships may overstate

19 sensitivity. This is certainly true, for

20 example, with cotton cultivars in California. 

21 The current cultivars are just less sensitive

22 for sure.
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1 My written comments talk about gas

2 exchange, water use, water cycling,

3 extensively. This is just incredibly

4 important. The discussion is somewhat

5 diffuse, scattered throughout that chapter,

6 and it is somewhat contradictory.

7 I would have to say that I am not

8 exactly sure what the bottom line is. We have

9 the studies of Sandy McLaughlin and the

10 indirect bringing in of watershed -- water

11 production from an ecosystem, but we also have

12 lots of experimental evidence that stomata

13 close in response to ozone. I don't think

14 there is a clear one answer, I suspect it

15 depends on type of vegetation and on other

16 factors. But I think a much clearer

17 discussion of those problems needs to be put

18 into the ISA.

19 That is not just a picky point

20 because the whole question of stomatal

21 conductance leads into the whole problem of

22 modeling based on uptake or fluxes. It
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1 relates to other things, very important

2 confounders such as water use and water

3 stress, stomatal closure, excluding ozone, et

4 cetera.

5 So, there are a whole bunch of

6 reasons that the stomatal argument needs to be

7 gotten right. I think there are a number of

8 studies in there that need to be better

9 explained and better integrated. The Sandy

10 McLaughlin studies are one. They kind of

11 stand out by themselves. And I think the

12 Jillian Gregg studies from Cornell, the Todd

13 Dawson/Jillian Gregg studies, have to be put

14 in there. When a paper hits Nature, it

15 becomes a very important study. But that is

16 a quirky study in many ways, and it comes up

17 on every third page in that chapter.

18 I really think somebody ought to

19 really go back and look at that and see really

20 what is that study telling us and what is it

21 not telling us? But they had an 85 percent

22 growth reduction with ambient ozone. I
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1 haven't seen that in chambers. I mean, that

2 is big. So, I would just go back and look at

3 how much weight we want to put on that single

4 study.

5 Another element is that it is

6 appropriately pointed out that ozone enters

7 the response mechanism of plants through the

8 ROS signaling networks, pre-existing networks

9 that are there for pathogen defense,

10 essentially. I think that is very important.

11 I also think that is at an

12 incredibly early stage of development. There

13 are sections where the authors start to go off

14 in explanations of jasminate and ethylene and

15 interactions here and there. First of all,

16 the explanations are a little bit simplistic,

17 particularly with jasminate, which I happen to

18 know a little bit about. Jasminate does a

19 great many things, and I don't think it is

20 well laid out.

21 But I also don't think it is

22 important that it be well laid out in this
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1 chapter. I don't think the science is at a

2 stage where that really adds plausibility, and

3 I don't think we need to get into that very

4 much. I elaborate on that in my written

5 comments as well.

6 There is another issue that comes

7 up in several places in this chapter. For

8 example, in talking about genomic effects or

9 transcriptional effects: just because

10 something responds does not mean that is a

11 mechanism of resistance, because you are

12 really looking at the potential for a response

13 that indicates something about upstream

14 defenses. And I think that logical mistake is

15 made in a number of places and probably ought

16 to be corrected.

17 Just because genes are transcribed

18 or not doesn't mean that is why the plant is

19 sensitive. It simply may mean that is the

20 plant that ozone got past the first level of

21 defense. We just don't really know the answer

22 to that.
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1 A number of times the extreme

2 sensitivity of reproductive tissues is brought

3 up. I don't think there is evidence for that. 

4 Even the very early papers that are by Black

5 that are cited numerous times don't really

6 show that. They show compensatory responses,

7 certainly; they may show effects directly on

8 reproductive structures, but they may not,

9 because those are photosynthetic stocks as

10 well. So, I think I would tone that argument

11 down a little bit.

12 And it doesn't detract from the

13 argument that the yield, which are

14 reproductive structures in most crops, are

15 heavily impacted by ozone; that is true. But

16 to make a big deal out of the extreme

17 sensitivity of reproductive structures, it is

18 not shown by the data that are presented. 

19 There are other types of data, pollen growth,

20 et cetera, that may be more direct to that

21 question.

22 And, then, there is another sort
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1 of general comment I wanted to make that in

2 several places it is measured that there was

3 a change without any indication whether it is

4 an adverse change or not an adverse change. 

5 And in some cases, it doesn't even indicate

6 the direction of change.

7 And, then, there is one wonderful

8 spot, which I don't remember where it is, but

9 it is in my written notes, where it only says

10 that something was measured, without even

11 worrying about whether or not it was changed. 

12 I think you need to really think about whether

13 these changes have some biological

14 significance.

15 That's it. Thanks.

16 DR. SAMET: Is the latter issue --

17 I mean, right now I think the focus in Chapter

18 1 on what is an adverse effect is all human,

19 isn't it? Is there one paragraph? I guess

20 maybe that concept needs to be broadened there

21 as well, as we move through the broader

22 ecological effects.
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1 DR. GRANTZ: Whether or not you

2 determine if it is or isn't adverse, one would

3 at least want to describe the direction --

4 DR. SAMET: Right.

5 DR. GRANTZ: -- and the logic by

6 which you might decide if it is adverse.

7 DR. SAMET: And certainly, the

8 American Thoracic Society statement is not the

9 right reference to cite.

10 Howard?

11 DR. NEUFELD: Okay. Thank you. 

12 It is always good to go third.

13 I think, if you look at this, the

14 beginning of Chapter 9 is almost identical

15 word for word with that in Chapter 2. So,

16 again, I would say that perhaps we can shorten

17 this chapter, get out some of the redundancy

18 and things like that.

19 And the section on the stomata,

20 echoing Dave, is that those discussions are

21 kind of scattered throughout in different

22 sections and somewhat redundant there. I
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1 think if it was reorganized a little better,

2 brought together, it would make the material

3 flow better and the conclusions come out

4 better also.

5 And, then, there are some specific

6 comments I had about some of the way things

7 were described, some of the biochemical

8 responses.

9 There was a discussion on page 9.6

10 about sensing ozone with proteins in the cell

11 wall or membrane and then gene activation. 

12 But there can be just pure physical reactions

13 prior to any gene activation. I think that

14 kind of argument should be brought in. I made

15 the analogy with auxin, where there is an

16 initial quick response, and then genes are

17 upregulated on a longer-term basis after that.

18 We have had a lot of hypotheses

19 about antioxidants and their role in defense,

20 and particularly their temporal status and

21 whether there is a minimum of defenses at

22 nighttime and things like this. There is a
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1 lot of speculation in the literature, but

2 there isn't a lot of hard-core evidence for

3 one way or the other. I think that is just an

4 area that we should at least leave open that

5 needs more work.

6 Then, I had trouble at the time

7 when I wrote these comments of getting into

8 the HERO database. So, if it has been cited,

9 I apologize.

10 But there was a paper by Heinrich

11 Sandeman published, that I didn't see in

12 there, I think, talking about some additional

13 biochemical reactions with antioxidants,

14 especially ascorbate, that when reactive with

15 those, it actually produces some other toxic

16 compounds. Perhaps that reaction ought to get

17 a little more weight in the document.

18 Let's see, and there's a couple of

19 other specific comments here about, again,

20 antioxidants, but I won't go into details on

21 those. They are in the written comments.

22 I echoed Dave's thing about the
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1 stomatal patterns with ozone, this stomatal

2 sluggishness, where they become less

3 responsive to environmental stimuli. There is

4 a lot of evidence that that is happening. 

5 Sandy McLaughlin's data indirectly seems to

6 indicate that. Nancy Grulke and Elena

7 Paoletti's data seem to indicate that across

8 a wide spectrum of life forms.

9 But there is not evidence

10 sometimes in looking at differences between

11 sensitive and tolerant individuals that that

12 is the mechanism causing that. Because when

13 there are no foliar symptoms seen, sometimes

14 you can't see any differences in stomatal

15 reaction among sensitive and tolerant plants. 

16 It is something that comes up as a result of

17 the injury. So, it would be inaccurate to say

18 that they are predisposing factors. Now they

19 could be in some species, but not all.

20 There hasn't been a lot of work in

21 recent years, but nitrogen deposition is

22 extremely important. I think nitrogen
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1 deposition can have a huge impact possibly on

2 responses of plants and ecosystems to ozone. 

3 And I think that that discussion needs to be

4 built up in the ISA.

5 I echo Kathy's comment that non6 vascular plants are almost totally ignored in

7 here. Mosses, for example, they may not be

8 particularly ozone-sensitive, but they cover

9 huge swaths of the earth's surface. And if

10 they do turn out to be affected by ozone, even

11 though they may have low rates of exchange,

12 the vast area they cover could end up having

13 ecosystem and landscape consequences.

14 Let's see. The section on

15 plant/insect interactions, it seems not to

16 have any real sharp general conclusion. I had

17 suggested that maybe the consensus is that

18 there is no consensus on how insects respond

19 to feeding on ozone-exposed plants. And that

20 is an area that, again, needs more work.

21 And, then, I don't know if it was

22 in, I can't remember if it was in the criteria
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1 document from before, but there was a paper a

2 number of years ago by Peter Tobiason on dark

3 opening of stomata. And if you have species

4 growing at high elevation where you have

5 essentially a flat ozone profile, so that the

6 ozone is high in the morning if the stomata

7 are open, then other conditions being

8 conducive to uptake, then you could have an

9 appreciable amount of ozone going into the

10 plants at a time when, at low elevations, that

11 same species would not be getting ozone.

12 And other work on that has also

13 been done by Lisa Donovan and others, looking

14 at fluxes at nighttime. So, that may be

15 something to back up, to look at.

16 And, again, I echo Dave's concern

17 about Gregg's data. That is a huge reduction. 

18 But there has been some other work by Paul

19 Brang and Dave Karnosky. It was in the

20 earlier document where they speculated that

21 some genotypes actually were eliminated from

22 the landscape, growing in high-ozone areas. 
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1 So, perhaps that discussion should be brought

2 back to put the Gregg paper into better

3 context.

4 And the rest of the chapter I

5 thought was a good summary of how natural

6 agricultural ecosystems responded to ozone.

7 And, then, I will leave it at

8 that.

9 DR. SAMET: Okay. Other comments? 

10 Yes, Peter?

11 DR. WOODBURY: Just a couple of

12 comments. I will be brief because I agree

13 with almost everything that has been said by

14 my colleagues on this topic.

15 I think this was brought up, but I

16 want to emphasize that a more critical

17 discussion and interpretation of model results

18 is needed. We've had some discussion today

19 already about atmospheric models. In the

20 plant world, we have a range of models that

21 have been used to try to understand and scale

22 up effects from specific organs or individual
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1 plants to the ecosystem scale.

2 These models have very different

3 assumptions. They operate in different ways. 

4 For example, some models assume that all

5 vegetation is one giant leaf and that it all

6 responds to ozone in one way. I will point to

7 a paper that is cited by Scott Ollinger using

8 a peanut model.

9 Other models represent many

10 physiological responses within plants,

11 individual plants. Other studies have linked

12 these more complex physiological models, such

13 as tree growth with stand-level models, to try

14 to assess the interaction of both ozone15 sensitive and less sensitive species in a

16 mixed vegetation community.

17 So, those are very kind of

18 different animals. And I think there needs to

19 be a little more critical discussion of the

20 strengths and weaknesses of various models and

21 what information can really be gained from

22 them.
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1 Similarly, I think bringing some

2 of that modeling discussion together and

3 linking it with the suggestion of bringing

4 together the discussion on stomatal

5 conductance, those two topics are related. 

6 So, if models make an assumption that stomatal

7 conductance decreases, you are going to have

8 a very different implication in the results of

9 that model than another study that may be

10 using data that suggests that things are

11 changing in the opposite direction.

12 So, again, I am adding to this

13 point of a need for a more integrated

14 discussion of effects on stomatal conductance

15 and then, a separate but related topic of an

16 integrated discussion of what we can learn

17 from different kinds of models.

18 There is a brief discussion of

19 effects of ozone on sacred fir forests in

20 Mexico and forests in the Carpathian

21 Mountains. I would suggest that this

22 discussion either needs to be expanded with a
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1 clearer kind of bottom line, what can we

2 actually tell from the studies that have been

3 done in these regions?

4 If it is the case that there is

5 fairly strong evidence of ecosystem effects,

6 then the inclusion of them is warranted. If

7 the evidence is not strong enough to really

8 point to ozone effects, that needs to be

9 clarified and, again, maybe related to some of

10 the other material in the chapter.

11 My last point, I have some written

12 comments that I have submitted. I won't go

13 over some of those detailed ones. But the

14 last point is that -- it has been brought up

15 by Kathy Weathers that there isn't that much

16 new literature. Some of the new literature

17 includes meta-analyses.

18 And as is well discussed in the

19 chapter, these meta-analyses of the new

20 studies tend to be a very limited type of

21 ozone exposure, usually an ambient and a twice

22 ambient. So, this is a limitation, especially
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1 in developing exposure response functions.

2 But I wonder whether it is

3 possible to try to compare these more recent

4 data with earlier data on a common metric of

5 exposure, even if it is a seven-hour mean. I

6 am not suggesting that a seven-hour mean is a

7 more appropriate metric. It is not, and I

8 don't think we need to discuss that too much

9 today. But it might provide a way to say, are

10 the new studies really showing something

11 different from the older studies or not?

12 That's it.

13 DR. SAMET: Okay. Other comments?

14 DR. GRANTZ: If I could make just

15 another couple of comments that Howard

16 reminded me of?

17 DR. SAMET: Yes, Dave?

18 DR. GRANTZ: First of all, this

19 nighttime stomatal opening appeared in the

20 early eighties in the context of the blue

21 light response. And there are a couple of

22 papers by Eduardo Zeiger and Chris Fields, and
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1 others, that you should probably think about,

2 because nighttime opening is a real

3 phenomenon, and maybe not just in high

4 elevations.

5 The other thing that I actually

6 meant to say and forgot is that there is a lot

7 of text in this chapter on target proteins in

8 the apoplast. I don't think we know anything 

9 about target proteins in the apoplast. And,

10 then, when it said that the initial site of

11 impact of ozone is likely to be in the

12 apoplast, that is hedged multiple ways.

13 Well, I would reverse that. I

14 think we know that ozone hits the apoplast

15 first, just because physically it more or less

16 has to. And I think we know absolutely

17 nothing about target proteins. I think that

18 is a completely mistaken way to say that. 

19 There may be proteins that are targets, but

20 there is no ozone target. There is no ozone

21 receptor, at least at current levels of

22 understanding. I think that is a mistake to
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1 have it in there that way.

2 DR. SAMET: Okay. Ed?

3 MR. AVOL: Just to follow up on

4 something Dave Grantz suggested earlier, this

5 is out of my field, so I didn't actually

6 appreciate this. But, on page 9-18, there is

7 a section on experimental exposure

8 methodology. If, in fact, it is the case that

9 you sought to dispel this sort of simmering

10 controversy between the open chambers versus

11 the indoor chambers, but that doesn't come

12 out. I was trying to figure out why we

13 diverged into this discussion of how you go

14 about doing these studies.

15 And so, if, in fact, that is the

16 case, and in that context that makes a lot of

17 sense why he would say something, I think you

18 should say something in that introductory

19 paragraph, that there has been this concern

20 about it.

21 DR. SAMET: Okay.

22 DR. HERRICK: I just want to say,
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1 later on in the chapter, we talk more about

2 the comparisons toward the end of the chapter. 

3 So that part, we are just sort of setting up

4 what are the methodologies that we are going

5 to refer to later in the chapter.

6 So, that 9.3 was sort of just to

7 get our terms down, like what is an open-top

8 chamber and what is a field study, so we

9 wouldn't have to rephrase it every time during

10 the rest of the chapter.

11 MR. AVOL: Right, but without the

12 guidance --

13 DR. STALLWORTH: Can you introduce

14 yourself?

15 DR. HERRICK: Oh, I'm sorry. I am

16 Jeff Herrick from NCEA, an ecologist.

17 MR. AVOL: Okay, but as a naive

18 reader without the guidance about why this is

19 all being set up in parallel, I would say, in

20 the acute effects study why don't we talk

21 about all the different kinds of chambers and

22 how people go about doing the exposures, which
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1 I think would be out of place in this

2 document?

3 DR. SAMET: Okay. Other comments? 

4 Anyone on the phone? Yes, Dave?

5 DR. CHOCK: This is not a comment.

6 DR. SAMET: Okay.

7 DR. CHOCK: Being not an expert in

8 this area, I can ask some wild questions. 

9 First, vegetation also emits biogenic

10 emissions, so I wonder if ozone has any impact

11 on the biogenic emissions. So, this is sort

12 of a feedback issue.

13 And the second question is, I look

14 at the slide that EPA showed on the cottonwood

15 thing. The plant becomes very tiny after

16 exposure to ozone. So, my question is whether

17 there are any studies on the carbon storage

18 issue when the plants are exposed to ozone.

19 DR. HERRICK: Yes, we cover some

20 of the studies on carbon storage. It is very

21 difficult to study because you have to expose

22 a whole ecosystem, and there's a few field
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1 studies that try that. But a lot of it, we

2 used modeling examples to look at carbon

3 sequestration.

4 DR. SAMET: Okay. One other issue

5 that came up, and I can't remember who

6 commented on this sort of overlap between

7 Chapters 2 and 9, and there is sort of

8 verbatim text from others that have gone in.

9 Chapter 2, I think, is intended to

10 be integrative, and there is some comment

11 about, I think, across the different panel

12 members as to whether it is an executive

13 summary or what exactly is it. It is clearly

14 not yet what it should be. And I think that

15 is why these comments have surfaced, and this

16 is only one example where people are saying,

17 well, why say in Chapter 9 what you have

18 already essentially said in Chapter 2? The

19 meat of what is in Chapter 9 is there.

20 I mean, what really should be

21 carried forward are the main points and, then,

22 there should be some integrative discussion. 
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1 I know we are going to discuss Chapter 2

2 later, but this is one of the places where

3 that comment has surfaced. And I think I just

4 wanted to again flag that, recognizing that

5 Chapter 2 is still, I'm sure, a work in

6 progress.

7 Let's see. Perhaps, David, if you

8 could take on the summary for this, since

9 Kathy is not here? So, it is, apparently, a

10 good way to avoid the job of drafting the

11 answers, to stay on the phone.

12 (Laughter.)

13 DR. WEATHERS: Right. If your

14 last name doesn't start with "W", then --

15 DR. SAMET: That's right. I can

16 see at our next panel meeting everybody will

17 be on the phone.

18 (Laughter.)

19 DR. WEATHERS: Yes, exactly.

20 DR. SAMET: Peter?

21 DR. WEATHERS: Dave, would you

22 mind emailing to me the draft, and I will
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1 respond via email?

2 DR. GRANTZ: Yes, of course.

3 DR. WOODBURY: I did just want to

4 repeat a point that was already made because

5 it is really extremely important. And that

6 is, first of all, I want to say good job on

7 this chapter. I think it does cover the

8 material in general that needs to be covered.

9 But the new information coming

10 from the FACE studies, the free-air exposure,

11 and the linkage that is made in this document

12 with the former NCLAN studies. It is

13 emphasized in the document how critical that

14 is, but that is really extremely important. 

15 As Dave Grantz said, it is basically a whole

16 other technology that has laid to rest

17 concerns that have been brought up for 20

18 years about the NCLAN data, and demonstrates

19 conclusively that the exposure response

20 functions are valid and are applicable from an

21 entirely separate line of evidence.

22 So, I think you did a good job of
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1 emphasizing that. I just want to say it again

2 because it can't be overemphasized, as we move

3 into the next phase of trying to do a more

4 quantitative assessment of response to ozone

5 exposures.

6 DR. NEUFELD: And I wanted to add

7 two other points. One is sort of

8 methodological. If you don't have open-top

9 chambers or any way of doing controlled

10 exposures, then you are faced with a situation

11 of trying to assess an ozone impact in the

12 natural world without a control. So, how do

13 you do it?

14 And so, my group has adopted a

15 strategy, whether it is flawed or not, of

16 looking at individual variability within

17 individuals of a species, looking at sensitive

18 and tolerant genotypes and at least saying,

19 okay, we see this range of response due to

20 ambient ozone. Maybe there should be some

21 discussion of that tactic or methodology, and

22 the limitations that are associated with it,
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1 but also the information that you do get.

2 The other thing would be, related

3 to that is the elimination of sensitive

4 genotypes. You can't see it. So, you can get

5 changes in ecosystem function like nutrient

6 cycling that you might be able to see. But if

7 you lose the sensitive genotypes, you have got

8 a change in composition. The species is still

9 there, but not the full complement of

10 genotypes. So, that is something that maybe

11 should be brought up.

12 And the last thing is, as one of

13 the people who lives at high elevation, the

14 profiles at high elevation tend to be fairly

15 flat. There isn't much discussion in Chapter

16 3 or the ISA about the mountain profiles of

17 ozone, you know, diurnal profiles. Perhaps I

18 would like to see that a little beefed-up, and

19 whether it has changed, say, over the last

20 decade or so.

21 Because there was a mention in

22 there of the lower-elevation profiles being
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1 fairly similar, even though maybe the absolute

2 levels are going down, but there was no

3 discussion of high-elevation profiles. I

4 think that is an important thing to add.

5 DR. SAMET: Fred?

6 DR. MILLER: Yes, Jon, I wanted to

7 return to your comment and the questions about

8 Chapter 2. I think before we leave here, and

9 maybe it is at the end-of-the-day discussion,

10 whether or not, personally, I feel that this

11 chapter is out of place, that it ought to be

12 the last chapter, if it is really integrative. 

13 And it might serve, a shortened version of it,

14 as an executive summary.

15 But I think we ought to give some

16 clear guidance because, to me, you shoot half

17 your wad to start with, but you don't really

18 make the case as strongly because, if the

19 reader had read all the other chapters and

20 they got to this, they would have a tight hold

21 on how this has been integrated.

22 And so, I think your point is
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1 well-taken is this is something that we really

2 ought to provide very specific advice before

3 we leave.

4 DR. SAMET: George?

5 MR. ALLEN: A quick follow-up to

6 the flat diurnal profiles. There actually are

7 cases where you get that not at high

8 elevation. In rural areas, in this case my

9 experience was in central Wisconsin, I did an

10 audit of a site, and I thought the ozone

11 analyzer was broken because it was flat at 60

12 ppb hour after hour after hour after hour

13 after hour. Now it turns out it is just the

14 middle of nowhere, and even though it is

15 surface and flat, very little profile. So,

16 I'd throw that out there as something to

17 consider.

18 I was stunned, and I suspect you

19 can go out there and get the data now. This

20 was 15 years ago. It is probably still the

21 same, maybe a little higher.

22 DR. SAMET: Okay. I am going to
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1 suggest that we move on to one more charge

2 question before lunch and deal with question

3 11. Then, we would be ready to shift after

4 lunch back to human health. So, this is

5 climate change and UV-B effects.

6 Howard, you are the lead here.

7 DR. NEUFELD: This is Chapter 10,

8 right?

9 DR. SAMET: Chapter 10, correct.

10 DR. NEUFELD: Okay. I thought

11 this was a well-written summary of the direct

12 and indirect -- I am essentially reading what

13 I have here because I only had very short

14 comments here. But it was a well-written

15 summary of the direct and indirect effects of

16 tropospheric ozone on UV-B radiation impacts. 

17 I thought the chapter discussed

18 climate forcing due to ozone and relative to

19 CO2 and methane in a really nice way and

20 distinguished it between long-term and short21 term greenhouses gases.

22 In discussing recent ozone trends,
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1 Henry Lee and others had a paper out recently,

2 2003, going back trying to reconstruct the

3 trends in California. I am not sure if that

4 was, again, because of the HERO database, I am

5 not sure if that was cited, but maybe they

6 could consider that.

7 But, in conclusion, it was fairly

8 evaluated, the research to date, and showed

9 that there is a paucity of studies of how

10 tropospheric ozone is going to affect UV-B. 

11 The last sentence I agree with. It says, "The

12 effects of changes in surface-level ozone

13 concentrations on UV-induced health outcomes

14 cannot yet be critically assessed within

15 reasonable uncertainty." And I agree with

16 that.

17 DR. SAMET: Okay. Let's see,

18 Peter?

19 DR. WOODBURY: Yes. In response to

20 this question, I think this chapter is useful. 

21 It is a complex topic. I am not an

22 atmospheric modeler. So, I have a couple of
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1 questions and a couple of comments.

2 I guess a question I have for both

3 the staff and perhaps some of the atmospheric

4 chemists and modelers in the room here is:

5 might there be effects of ozone at the

6 regional and continental scale, in addition to

7 the global scale? So, I am thinking of

8 radiative impacts. I don't have an answer to

9 that question. I will put that out there in

10 case anyone else does.

11 And I guess, to elaborate on that,

12 could such regional impacts be additional to

13 the range of impacts on radiative forcing that

14 are cited from IPCC? If so, then maybe a

15 regional or a continental impact discussion

16 would be warranted.

17 Another point, on interaction with

18 vegetation, so there may be complex and

19 important interactions with vegetation. So,

20 I think this is a challenge, due to the

21 limitations of the modeling and the

22 heterogeneous response of different types of
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1 vegetation. So, in other words, the

2 publication that is cited by Sitch et al.,

3 from 2007, I am not sure whether that

4 publication really could represent a variation

5 in response to ozone among genotypes within a

6 species or among species, the discussion we

7 have just been having.

8 So, there is evidence from both

9 experimental -- direct evidence from

10 experimental work with open-top chambers, as

11 well as a number of modeling studies that show

12 that in a mixed-species community, where you

13 have sensitive and insensitive species, the

14 overall effects may not be so much a change in

15 total growth, that may not be the most

16 sensitive response of a vegetation community. 

17 Instead, you may see a replacement of

18 sensitive species with insensitive ones or

19 sensitive populations being eliminated, as we

20 have already discussed.

21 So, I think -- the reason I am

22 bringing this up in the context of climate
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1 change is, I think we shouldn't overemphasize

2 impacts of ozone only on growth of an entire

3 ecosystem or net carbon exchange. There may

4 be such effects, but that may not be the most

5 sensitive response, either to ozone or to

6 direct effects of ozone or effects of climate

7 change on vegetation.

8 Again, I guess I will raise this

9 as a question. My understanding of current

10 atmospheric models are that they seem to

11 overestimate pre-industrial ozone

12 concentrations; I think Daniel Jacob brought

13 up this point earlier today.

14 And my understanding of that, and

15 I would be glad to be corrected or have other

16 folks speak on this who know more than I do,

17 but my impression is that that my be

18 inadequate parameterization. Obviously, we

19 don't have the historical data we would like

20 from 100 years ago to parameterize models, but

21 there also may be missing chemistry.

22 So, this implies to me that there
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1 may be substantial uncertainty about non2 anthropogenic ozone concentrations. And I

3 guess I am raising this again in the context

4 of the policy-relevant background

5 concentrations. In other words, if the models

6 are overestimating pre-industrial

7 concentrations, does that imply they are also

8 overestimating policy-relevant background

9 concentrations? Again, that is a question.

10 And then the conclusion, that

11 there is a causal relationship between

12 tropospheric ozone and radiative forcing

13 certainly seems warranted, as is the

14 conclusion that there is likely to be a causal

15 relationship between tropospheric ozone and

16 climate change.

17 That's it.

18 DR. SAMET: Okay. Thank you.

19 Daniel?

20 DR. JACOB: Yes. Overall, I

21 thought it was a very good chapter.

22 Just to follow up on Peter's point
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1 and respond to a couple of his comments, he is

2 right that the regional structure of climate

3 response to ozone radiative forcing could

4 receive a little bit more play.

5 It is still pretty large-scale,

6 because the ozone forcing is only happening in

7 the middle and the upper troposphere. So, it

8 is not like you are going to have a regional

9 climate response, like you have for aerosols. 

10 But, still, you have more response in the

11 Northern Hemisphere than the Southern

12 Hemisphere to emissions or precursors in the

13 Northern Hemisphere. And that could be played

14 up a little bit more.

15 Yes, with regard to the fact that

16 models overestimate ozone concentrations

17 observed at the turn of the 20th century, this

18 is a very sore point because, if we use the

19 observations at the turn of the 20th century

20 to anchor a radiative forcing calculation, we

21 get a radiative forcing that is double what

22 you have in the IPCC estimate. So, radiative
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1 forcing then becomes comparable to, say, that

2 of methane.

3 And it is interesting because,

4 whereas for the other gases you have ISCOR

5 data to anchor the pre-industrial values that

6 are used for radiative forcing calculation,

7 for ozone all you have are models. And as

8 Peter points out, the models for pre9 industrial atmosphere may not be very good. 

10 And so, therefore, yields in radiative forcing

11 may be underestimated. This maybe could

12 receive also a little bit more play.

13 I have a sprinkling of other

14 comments on that chapter. I just want to

15 bring up two points that I think are

16 important.

17 The first one is, when you express

18 radiative forcing with respect to ozone, it is

19 actually not very helpful for policy because

20 you can't directly control ozone. So, you

21 control NOx. But when you control NOx, you

22 have effects on methane, you have effects of
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1 aerosol nitrate, which actually counter the

2 benefit that you would have in decreasing

3 ozone, and controlling NOx is actually

4 considered not to be very good for climate

5 change.

6 So, the only way to effectively

7 control ozone, in a way that provides a

8 winning scenario for climate change, is to

9 control methane. And that point was made in

10 the last IPCC report for the first time, and

11 I think it definitely should receive more play

12 in that chapter. I have this in my written

13 comments.

14 In fact, if you look at the short15 term horizon, that is, if you look at the

16 effect of present-day emissions on climate

17 change over the next 20 years, what you find

18 is that methane emissions are more important

19 than CO2 emissions. And that is in the IPCC

20 report. I am not making that up.

21 They are more important than CO2

22 emissions. And that is, in part, about one
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1 third, because of the effect on ozone. So,

2 this is, again, a really big deal.

3 Okay. The second thing that I

4 thought should be played up a lot more is the

5 so-called RCP scenarios that are going to come

6 out in the fifth IPCC Assessment Report, the

7 one that is going to come out in 2014.

8 Right now, all the calculations

9 that are being done for 21st century climate

10 change are done based on the so-called SRES

11 scenarios that were put out in the third IPCC

12 report back in 2000. Those are going to be

13 retired as of this year. As of next year,

14 nobody is going to be using them anymore. 

15 People are going to be using those so-called

16 RCP scenarios, Representative Concentration

17 Pathways, which kind of map the previous

18 scenarios in terms of CO2 and overall

19 radiative forcing.

20 But in terms of the air-quality21 relevant gases -- and it is a point I made

22 before -- they are totally, totally different
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1 than the previous SRES scenarios. And, in

2 particular, methane doesn't increase any more

3 in the 21st century. NOx is dropping. VOCs

4 are dropping.

5 These drops are global, right? 

6 So, maybe they have to be taken with a grain

7 of salt. Maybe work has to be done on those

8 emission scenarios. But they are really going

9 to totally change the outlook in terms of the

10 effect of air-quality-relevant gases for

11 climate forcing.

12 And before we lament and say, oh,

13 maybe that makes the air-quality-relevant

14 gases not so important for radiative forcing,

15 I would say, on the contrary, because if NOx

16 emissions really drop a lot, then we have a

17 chance to witness the effect of NOx emissions

18 on climate forcing over the next few decades.

19 So, those are my comments.

20 DR. SAMET: Okay. Other comments

21 on charge question 11, Chapter 10?

22 (No response.)
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1 Anybody on the phone?

2 DR. WEATHERS: No, nothing to add.

3 DR. SAMET: Nothing to add? Okay.

4 Let me just -- last chance for

5 takers. Then, let's see, sticking with the

6 first, doing the summary, Howard, would you

7 feel comfortable taking that on?

8 DR. NEUFELD: For this one?

9 DR. SAMET: Yes, for this one.

10 DR. NEUFELD: Sure. As long as I

11 get lots of help from Daniel.

12 DR. SAMET: Okay. All right. 

13 Help is promised.

14 Well, we are running ahead of

15 schedule, which is okay. So, we are at lunch.

16 What I am going to suggest that we

17 do stick with the one hour for lunch. So, try

18 to get back by 1:15 to get going again.

19 (Whereupon, the foregoing matter

20 went off the record at 12:13 p.m. and resumed 

21 at 1:23 p.m.)

22
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1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N

2 1:23 p.m.

3 DR. SAMET: So, we are moving on. 

4 We are back to people, human health. And we

5 are going to start with exposure.

6 Ed?

7 And why don't you just make the

8 assumption that you are going to be writing

9 this up, Avol.

10 DR. FREY: You should have phoned

11 in.

12 (Laughter.)

13 MR. AVOL: All right. So, this is

14 charge question 5 on Chapter 4, the exposure

15 discussion, as Jon mentioned, to open the

16 discussion on human effects.

17 There are several useful and well18 done pieces of the chapter, but, in general,

19 one comment I had was that I think it needs a

20 better summary. The summary that it has in

21 there is four-pages-plus long. And it is not

22 a summary as much as another section.
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1 And so, I think it would be

2 helpful to sort of be concise about what

3 actually is going on there. In my written

4 comments, I made some suggestions for you

5 which you can take or not, but I think the

6 point is to try to improve it.

7 Another comment, just on sort of

8 the structure, is I think it would be useful

9 to have some sort of needs assessment about

10 what you think is missing that would really

11 help make a meaningful contribution for the

12 next cycle, if not the current cycle, in terms

13 of where the data gaps are that are missing

14 from the studies, missing from the

15 information, missing in terms of exposure or

16 monitoring, et cetera, to sort of help guide

17 what the agency thinks is needed to make

18 progress. And I don't see any of that there.

19 On the scientific side, I do have

20 a couple of questions. There's a couple of

21 sections, one on population proximity to ozone

22 monitors and another on spatial temporal
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1 variability.

2 And so, the focus of the document

3 pretty quickly gets to talking about

4 population urban exposures and picks 12 urban

5 communities and talks about them. Obviously,

6 that is important, because you study effects

7 where the people are.

8 But, I mean, I think there are

9 some important differentiation between urban

10 and rural exposures that I think are lost

11 here. And that is that, in the urban case,

12 because of the combustion emissions and the

13 NOx titration, you generally have a sharper,

14 more defined peak, in terms of ozone exposure

15 during the course of the day. And so, that

16 has implications both in terms of exposure and

17 dose and temporal spatial activity patterns,

18 et cetera, and how that all interplays into,

19 ultimately, the effects.

20 In rural areas, that peak is a

21 much broader, more sort of mountain-type

22 representation. And so, while you don't get
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1 the high peak exposures, you get a longer

2 duration of exposure. And for people that

3 live not in the city, but sort of downwind of

4 it or something, and in southern California,

5 for example, the examples might be downtown

6 Los Angeles or Riverside compared to Lake

7 Arrowhead or Lake Gregory up in the mountains.

8 And for those that are cognizant

9 of the monitoring data, Lake Arrowhead reports

10 the highest exposures, probably, in the

11 country because, you know, the exposures sort

12 of look like a broad mountain for hours and

13 hours at a time. They don't go down. They

14 are not titrated by NOx. There are no local

15 core emissions. And so, I think in terms of

16 thinking about exposure, somehow that has to,

17 I think, be captured in there.

18 And, then, that sort of gets into

19 the issue of intercommunity variability of

20 ozone concentrations. I mean, we have always

21 sort of thought about that, partially because

22 of this neighborhood scale approach of placing
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1 monitors, sort of hoping to, you know,

2 specifically being away from roadsides, et

3 cetera. Now we have this broad sort of

4 regional view of what ozone is, that it is a

5 regional pollutant, that we don't see this

6 sort of fine resolution.

7 But when, in fact, we look within

8 communities, we see very strong variation. 

9 And understanding exposure, understanding

10 dose, has to somehow take into account

11 understanding that variation, that finer

12 structure variation, which we don't see by

13 looking at the neighborhood scale monitors.

14 But, in fact, many studies, our

15 studies, the Children's Health Study and

16 others, around the world, in fact, are showing

17 this roadside effect, which is sort of a

18 reverse ozone effect. But, again, looking

19 across the community, you see this much more

20 variegated pattern of exposure than this broad

21 sort of regional look at ozone. Somehow, I

22 think we have to sort of capture that.
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1 Then, I had some other minor

2 comments that will be in my written

3 participation, but I think that is it. And

4 with that, I will turn it over to Chris, I

5 think maybe on the phone.

6 DR. STALLWORTH: Chris, are you on

7 the line?

8 DR. FREY: I am on the line.

9 Yes, I liked Ed's comments and I

10 support those. I have some written comments. 

11 I just emailed them a few minutes ago to Holly

12 and Ed and David. And, also, on Chapter 2, I

13 emailed my comments to Helen. So, just so you

14 know those are there.

15 I think maybe what I would add to

16 what Ed said, and I think it follows on to

17 what he just said, was I guess in this

18 chapter, and also Chapter 2, there are

19 statements to the effect that there's low

20 spatial variability in ozone, and that the

21 temporal correlation in ozone is moderate and

22 implied to be strong enough that it wouldn't
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1 introduce bias in epidemiological studies. 

2 And I am not an epidemiologist, so I would

3 defer to some others on the panel.

4 But I guess I would at least

5 suggest that what is given in Chapter 4

6 doesn't convince me as a reader that that is

7 a particularly strong conclusion or finding. 

8 And it seems more like an assumption or what

9 we hope would be -- our wish, if we could have

10 our wish, that that be true.

11 So, the claim of low spatial

12 variability seems contradicted, as Ed

13 indicated, by things like NOx titration just

14 downwind of roadways. And we know those are

15 significant locations for either residential

16 populations or work or school activity. And

17 so, those are non-negligible parts of looking

18 at human exposure.

19 And, then, in terms of the

20 temporal correlations, the evidence that is

21 given in the chapter is a little bit unclear

22 maybe or could be organized more clearly as
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1 far as averaging time. But what I interpreted

2 was, as you go to longer averaging times the

3 correlation gets stronger, which we would

4 expect. But the correlation gets strong when

5 you get to averaging times of a day or four

6 days, and that is well beyond at least the

7 current eight-hour average that is used in the

8 current standard.

9 So, maybe there needs to be some

10 consideration of a little more association

11 between averaging time and temporal

12 correlation, and then whether or not the

13 assumption that a central site monitor is

14 relevant would depend on the averaging time,

15 as well as the spatial variability.

16 I think George Allen also alluded

17 to, in Boston, that there are some issues

18 there with spatial variation that are a little

19 complex than just assuming a central site

20 monitor or the nearest monitor would be

21 useful.

22 So, I think, just to summarize,
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1 the chapter, either this chapter or later,

2 should more critically address the adequacy of

3 central site monitors for use in

4 epidemiological studies, because I really

5 wasn't convinced by what was written there and

6 it seems a little weak.

7 I think my other comments on

8 Chapter 4 are really more editorial. And so,

9 they are in my written comments, but I won't

10 take time now.

11 So, that's it.

12 DR. SAMET: Okay. Thanks.

13 I think Dave.

14 DR. CHOCK: Okay. I want to echo

15 the comments of Ed and Chris. I think the

16 chapter is very well-written.

17 And I would say that my answers to

18 some of those questions are really in the

19 affirmative and just questions maybe,

20 especially when we are talking about long-term

21 exposure and short-term group-level and, also,

22 community-level exposure based on temporal
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1 variability rather than spatial variability.

2 I do have a few comments. One, in

3 particular, is that even though both ambient

4 PM 2.5 and ozone are secondary pollutants,

5 special concentration patterns need not be

6 similar, especially in a populated urban

7 environment with spatially uneven NO sources,

8 as has already been pointed out.

9 But I want to point out a specific

10 paper that was quoted in the chapter, a 2010

11 paper by Sona, et al. It concluded that the

12 PM 2.5 and ozone are spatially more

13 homogeneous and, thus, the effects are less

14 sensitive to the choice of ambient monitors as

15 compared to primary pollutants monitors like

16 CO and NO2 monitors.

17 And if you look at the paper,

18 however, you will see that the authors used

19 different averaging times to characterize the

20 pollutant concentrations: 24 hours for PM

21 2.5, 8 hours for ozone, 1 hour for CO and NO2. 

22 This would actually inadvertently and
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1 preferentially increase the smoothing of the

2 spatial distribution and, also, of PM 2.5 and

3 ozone. And this spatial smoothing is applied

4 only to ozone and PM 2.5 and not to CO and

5 NO2. So, the message is misleading there.

6 But I would still say that the

7 value of the paper is not diminished because

8 the paper, in effect, smooths out the interday

9 spatial variability in order to study the

10 health effects of ozone concentrations based

11 on their interday variability.

12 The chapter describes the

13 correlation between indoor ozone and, also,

14 the outdoor ozone, but they only have one

15 correlation coefficient number provided by Ed,

16 the .58 in the Los Angeles study. I wish that

17 the authors would look more into this kind of

18 correlation coefficients for other cities as

19 well. I don't know whether they are

20 available.

21 And there are also some

22 mischaracterization of the work by Soo and
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1 Zanobetti. And I describe this in my writeup. 

2 And so, I don't want to make any further

3 comment on that.

4 And that is about all I have.

5 DR. SAMET: So, I think two

6 comments. One, I just want to go back to Ed's

7 comment about research needs. I suspect that,

8 at least in my mind, probably the ISA may not

9 be the right place to put the research needs. 

10 Maybe it is in the policy assessment document. 

11 I am not sure.

12 What is your view? I mean, if the

13 ISA is the integrated synthesis, it does allow

14 one opportunity to say, having done the

15 synthesis, here is what is needed. But it

16 seems to me that, when you get to the point 

17 of the policy assessments, at that point that

18 you can highlight the key uncertainties from

19 the point of view of future decisionmaking

20 that might best be addressed for research.

21 So, John, your thoughts about

22 that? And I would like other panel members to
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1 weigh-in.

2 DR. VANDENBERG: Well, I very much

3 would appreciate other views as well. But in

4 the past we had created a separate document

5 which is a research needs document. I think

6 that we stopped doing that in the nineties,

7 sometime mid-nineties, as I recall.

8 And it was really a reflection of

9 time and resource limitations. We were not

10 meeting any of the timelines we were needing

11 to meet.

12 So, it was a focusing on just the

13 air quality criteria documents. I think that

14 certainly the research community would benefit

15 a lot, and I think we have heard that from a

16 number of different committees and people here

17 as well.

18 You raise a very good point,

19 though. What is the right time to do that? 

20 Is it the end of the cycle when you see really

21 how the risk and exposure assessment benefit

22 from the ISA? The policy assessment benefits
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1 from both the ISA and the risk and exposure

2 assessment.

3 So, I think we can take back your

4 encouragement to perhaps developing a research

5 needs item, because I think there is a lot of

6 interest within the agency as well. 

7 Similarly, we would benefit from the

8 perspective of perhaps the entire process, not

9 just this part of the process, but I certainly

10 would welcome --

11 DR. SAMET: Yes. I mean I propose

12 a policy assessment because it is at that

13 point that there will have been a judgment

14 made in the face uncertainty. And,

15 presumably, those key uncertainties that might

16 have, had they not been points of uncertainty,

17 the standard might have gone one way or

18 another, would seem to be most critical for

19 highlighting for future research. But, I

20 mean, again -- yes, Steve?

21 DR. KLEEBERGER: So, Jon, this

22 came up in the NOx and SOx discussions as
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1 well. How did we handle it then? Do you

2 recall?

3 DR. SAMET: I am looking at John. 

4 I am not sure I actually remember anything

5 very specific about this.

6 DR. VANDENBERG: I don't know. Do

7 you remember?

8 MR. LONG: I will just add one

9 thing, and that is that -- oh, I'm sorry, my

10 name is Tom Long. I am on the staff here, and

11 I worked on this Chapter 4, the exposure

12 chapter.

13 In certain areas where there has

14 clearly been an emerging area of research that

15 we think is going to be beneficial going

16 forward or that will provide some really

17 critical information for us, we have gone

18 ahead and put that in the document. But we

19 have not tried to be comprehensive in saying

20 here's everything that would need to be done

21 in order to get a perfect world.

22 And so, I think we can kind of
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1 follow a similar kind of path to identify some

2 areas that would be beneficial, but not maybe

3 go through this entire process of research

4 planning, research needs, because they are

5 somewhat of a separate function of that, too,

6 of course, in EPA to identify research

7 planning.

8 DR. SAMET: Judy?

9 DR. GRAHAM: I would support

10 John's statement of doing it later, after the

11 policy evaluation is done. I say that for

12 several reasons, many of which are historical.

13 And in the good old, bad old days

14 there was actually a separate section in all

15 the old criteria documents that talked about

16 research needs. They ended up being laundry

17 lists, for which there never was any funding.

18 And, then, it evolved to CASAC

19 would actually write the research needs. Now,

20 of course, staff wrote it and CASAC tweaked it

21 and put CASAC's name on it. Again, it was a

22 long list of laundry needs. Because, I mean,
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1 any researcher worth his salt can give you 10

2 more years and $100 million worth of research,

3 independent of its importance.

4 But I like the idea of waiting for

5 the result, so that it can be focused. But,

6 if you go that way, I would suggest that CASAC

7 be involved.

8 I do agree with what John said, to

9 be cautious about resources. I mean you see

10 in the OAQPS document: if resources permit, if

11 resources permit.

12 Well, I mean, I think there needs

13 to be a broader priority. EPA has a planning

14 process for its research program. And I guess

15 I am concerned about some of the research

16 needs that are in here, not they aren't good,

17 but that they are not consistent.

18 You could put a research need on

19 every other page. And so, why have it on this

20 section and not on that section?

21 DR. SAMET: Helen?

22 DR. SUH: I have a couple of
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1 comments, some of which has been touched on

2 before. But part of it has to do, I think,

3 with the writeup here.

4 I think when you talk about some

5 of the issues about day-to-day variability,

6 population monitors, describing the day-to-day

7 variability, well, that is really for a very

8 limited set of studies, I would say. That is

9 really looking at the time series kind of

10 studies.

11 But that I think doesn't really

12 speak to the long-term ozone studies. It

13 doesn't really speak maybe to the cohort type

14 of studies that people do.

15 And, also, I think the conclusion

16 that, given the spatial variability and the

17 activity patterns, and all these other

18 caveats, that it is still the population

19 monitors still explain the day-to-day

20 variability really might ignore, might be

21 appropriate maybe for children who spend a lot

22 of time outside, but for the elderly, for the
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1 mortality studies, maybe it is not

2 appropriate. So, I think an overall blanket

3 statement like that is dangerous.

4 And I think this goes to the

5 research needs, in that I think within there,

6 because there is not a lot of studies looking

7 at indoor/outdoor relationships or personal

8 ambient relationships, or even spatial

9 relationships within a city over the long10 term. But it could be pointed out that there

11 isn't that much data on this, but there should

12 be some caveat to know that this statement

13 might only apply to maybe the children only or

14 maybe workers outdoors. But their relevance

15 to people spending a lot of time inside, or

16 even people in low SES groups, might not be

17 there because those people often tend to live

18 near major roadways, where there might be less

19 ozone. There might be more error. So, I

20 think we just have to be very careful about

21 how those big, overarching conclusions are

22 framed.
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1 And I would suggest for these

2 research priorities that in some ways I think

3 the foundation should be laid throughout the

4 process. So, in the ISA I think it should

5 really say, well, this is the data that we

6 have, but we can't answer these questions

7 because we don't have that data.

8 And, then, as you get to the

9 policy assessment, I think, with the

10 uncertainty analysis, I think in the PM when

11 you had high priority, this really would

12 affect your risk assessment, can that somehow

13 lay out what kind of research might be needed

14 more.

15 And, then, I have some other

16 comments that I think relate to Chapter 2 as

17 well as Chapter 4. So, we will just hold that

18 maybe for later.

19 DR. SAMET: Okay. Fred?

20 DR. MILLER: Well, I never like

21 to, and never do, totally agree with my

22 colleague Dr. Graham.
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1 (Laughter.)

2 So, I think I ought to chime in

3 here and say I don't agree with waiting until

4 all of the policy is done because you will now

5 be at the next revision cycle, and you are now

6 another five years down the road. If you are

7 going to do it, it ought to be after the first

8 draft, where you have some aspects of policy,

9 and not wait until the finished product.

10 And the bottom line is that it

11 doesn't really matter anyway because research

12 at EPA is a zero-sum game. And when the PM

13 stories come about, if you had ozone

14 separately, you didn't get funded. So, this

15 is much ado about nothing, and we are kidding

16 ourselves to think that we can spend all this

17 time, identify all these research needs, and,

18 then, the agency is going to come up with

19 money and solve the problem. It does not

20 happen.

21 And quite frankly, we are at a

22 time cycle on this revision process where,
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1 after this, you don't have a hell of a lot

2 more space to go. And so, I really have to

3 say prioritize your money more carefully, and

4 coming up in the risk assessment stuff, it is

5 just not going to impact these other research

6 needs.

7 That is just 40 years of

8 experience, and 20 of them at EPA.

9 DR. SAMET: Fred, are you going to

10 tell me there's no Santa Claus?

11 (Laughter.)

12 DR. MILLER: Oh, Virginia, come on

13 now. I have grandchildren. Come on.

14 (Laughter.)

15 DR. SAMET: Actually, I think

16 Lydia wants to weigh-in, too.

17 I think one thing that I don't

18 think you should do is haphazardly sprinkle

19 research recommendations through the document. 

20 So, whatever you do, don't do that.

21 I mean I think Fred's point about,

22 well, timeliness of the recommendations is
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1 probably important, but the reality is a

2 different matter. But I think maybe you

3 should think about this and come back and tell

4 us what you want to do.

5 But Lydia I think was going to --

6 MS. WEGMAN: Just a small point,

7 which is we certainly do plan to include

8 research needs in the policy assessment. And

9 we will think about, Fred, your suggestion

10 that we include something in the first draft

11 of the policy assessment, if I understood you

12 correctly.

13 DR. SAMET: And perhaps if there 

14 is a place in the document, as it is

15 constructed now, it would be in this

16 integrative Chapter 2. And there is sort of

17 where you are pointing to how the information

18 is coming together. And if you see key gaps

19 that need immediate attention, that at least

20 would be the place to do it.

21 There was one other point that Ed

22 made that I just wanted to come back to. And
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1 that was his comment about the summary and its

2 length. I was just sort of scanning across

3 some of the chapters and looking at what comes

4 at the end. And it ranges from summary and

5 conclusions to summary and causal

6 determinations, to overall summary, to

7 nothing.

8 And I think you ought to have some

9 standardization of what you put at the end of

10 these documents, whether it is a brief rehash,

11 i.e., a summary, but, then, it shouldn't be

12 four pages, which I think was Ed's point. And

13 if it is a place where you are bringing

14 everything together, then maybe give it the

15 right name and decide if something called

16 "summary" comes after that. But I think it

17 probably ought to be a somewhat -- I mean,

18 admitting to the fact that the chapters have

19 somewhat different purposes, there still ought

20 to be some sort of commonality, I think, in

21 how you bring them to a close.

22 Let me say, anybody on the phone
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1 want to weigh-in here? I'm sorry, George.

2 Okay. Let's see, who is on the

3 phone, actually? Chris, you're there?

4 DR. FREY: I am here.

5 DR. SAMET: Okay. And, Sverre,

6 are you?

7 DR. WEATHERS: Kathy Weathers.

8 DR. SAMET: Kathy is there, okay.

9 And, Sverre, are you there?

10 (No response.)

11 Oh, good. Okay.

12 (Laughter.)

13 George?

14 MR. ALLEN: Thanks.

15 I want to do a sidebar here. And

16 that is exposure to products of ozone

17 decomposition, once the ozone from outdoors

18 gets inside. Now if we use the process of the

19 NAAQS lead exposure models, they worry about

20 lead inside that came from outside. So, I am

21 assuming we have a similar situation here.

22 There's literature out there. 
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1 Charlie Weschler, for one example, did a nice

2 piece on atmospheric environment in 2004,

3 saying, you know what? The ozone may go away,

4 but it doesn't go away nicely. Basically, you

5 have hydroxyls, radicals forming when the

6 ozone reacts with whatever is inside. And

7 that can, then, react with all sorts of indoor

8 stuff to make a lot of very nasty byproducts

9 which, presumably, have health effects.

10 Now there is a fair amount of that

11 in the literature, but I am wondering if that

12 is something that we need to be including in

13 this discussion of exposure, just a broad,

14 very broad question.

15 MR. LONG: There is a brief

16 section in the chapter on that citing some of

17 Charlie Weschler's work. But I would

18 appreciate some input on how much weight to

19 place on that.

20 DR. MILLER: You bring up a very

21 good point. Phil Hopke has an in-press

22 article measuring all the reaction products,
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1 secondary organic aerosols, and the mass rate

2 production in information that I think is

3 going to be a sentinel publication for how to

4 look at how much is produced for a whole

5 variety of these reaction products. And it is

6 hot off the press. It goes exactly to the

7 point you are making. It does actually give

8 you quantitative data to be able to

9 characterize this.

10 DR. SAMET: Judy?

11 DR. GRAHAM: Looking at the

12 exposure modeling section on page 4-12,

13 Section 4.4, it describes a bunch of models. 

14 And, fine, but I said, so what? It doesn't

15 give me any results.

16 Now it could be this was

17 purposeful because you have to have a delicate

18 balance with the exposure assessment that

19 OAQPS is going to be doing. But what I am

20 thinking is that there might be a couple of

21 instances here where you could describe the

22 results of a model. Even instead of giving
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1 like the activity pattern data from the NHAP

2 survey, to maybe just give a couple of results

3 of what the exposures might be based upon

4 that. Make it a little bit more meaningful.

5 DR. SAMET: Okay. Anything else

6 on this question?

7 (No response.)

8 Okay. Ed, you are -- if you don't

9 mind?

10 And, then, Fred will move on to

11 dosimetry.

12 DR. MILLER: Given that I have the

13 floor, I think it would be appropriate to

14 request a motion of the floor that the last

15 discussant listed now be the person in charge

16 of writing things up.

17 (Laughter.)

18 Do I hear a second on it?

19 (Laughter.)

20 Well, enough said.

21 In terms of dosimetry and mode-of22 action chapter, the first question was about
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1 whether or not basic dosimetric principles of

2 ozone uptake were accurately presented in

3 sufficient detail. I maintain they are not,

4 except the things that are discussed are

5 factors that influence dosimetry.

6 If Jim Ultman would get involved,

7 he would tell you these are not principles of

8 dosimetry. The principles involve bulk

9 convection, axial dispersion, effective radial

10 diffusion, solubility, Henry's Law, all of

11 these kinds of things. And this just isn't

12 touched on at all.

13 What is really covered is more of

14 the reaction to ozone with various molecules

15 in the ELF and in the tissue. And that is

16 just one part.

17 So, this may have been just a

18 running-together of words, but these are not

19 principles that are discussed in here. They

20 are factors like exercise, age, et cetera,

21 ventilation, that affect dose. But the

22 principles of dosimetry are grounded on the
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1 physics of gas transport and removal. And

2 there is nothing in here on that.

3 So, if you want to rephrase the

4 question, I would say they have done a good

5 job at looking at most of the factors that

6 influence dosimetry, but not really a writeup

7 on dosimetric principles, per se.

8 In terms of the mode-of-action

9 question, the overview was, the approach taken

10 to characterize it and related effects, what

11 are our views? I will say that, as an aside,

12 it is not clear why the two are lumped,

13 dosimetry and mode of action. In the mode-of14 action material, it is a mixture of effects

15 studies described as well as mechanistic. And

16 so, it really is debatable about, wherever it

17 is placed, it may be here just as well as

18 another, but it does lead to some duplications

19 of material that maybe could be avoided, if

20 you were trying to cut down more.

21 The summary figure on page 5-62 of

22 possible modes of action, to me, is an
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1 excellent one. But I would have put it at the

2 beginning of the discussion of mode of action

3 and I would have included the section numbers

4 that now discuss subsequently, and, then, I

5 would keep it at the end as far as the summary

6 because, when I got through all of this to the

7 end, I thought, boy, I wish I had seen that

8 earlier because it now started to make sense

9 in terms of the end relationships and the

10 different pathways. So, that was a

11 possibility.

12 As far as some of my general

13 comments that I have written up, I want to

14 address a few of them. There is a number of

15 places in here where, when you are looking at

16 these factors, and they are all from human

17 exposure studies and chamber studies, and it

18 basically says this study shows that ozone

19 does that. Almost every single one of them

20 are merely a reaffirmation of what was

21 predicated by mathematical dosimetry models a

22 minimum of 10 to 20 years earlier. And, yet,
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1 those models aren't mentioned at all.

2 Now the fact that I am a senior

3 author of one, you know, you can say okay, but

4 there are other people in the room that have

5 developed also. And it would strengthen the

6 conclusions that you draw by referring to

7 these models along the way, that, in fact,

8 these things are in agreement and what has

9 been predicted.

10 And as an example of this, in the

11 homology section, there is a statement about

12 that it is difficult to cross species and

13 that. And, yet, if you presented a figure

14 from Gary Hatch, who has worked with monkeys,

15 and you presented my 1985 figure for the

16 tissue dose of ozone, they are absolutely

17 reflective images of one another in terms of

18 the amount at 1803 that he measured 15 years

19 after I predicted it in monkeys in the tissue

20 pattern identical to what the model shows for

21 ozone. Now the Y-scale is different, but the

22 pattern is there. And if that doesn't talk
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1 about species homology, I don't know what in

2 the hell does.

3 And so, some of these things just

4 really get to the point of not maybe going far

5 enough in terms of the interrelationship of

6 tying together not only the mathematical

7 models and the human studies, but also the

8 animal tox results. There's situations in

9 here where some of the studies are described

10 in terms of the primate studies that are more

11 recent. And, yet, there is no mention at all

12 of the Crapo-Chang studies in rats at .12

13 parts per million, showing structural changes. 

14 There's no reference to the EPA chronic study

15 of a diurnal ambient pattern that showed

16 structural and functional changes in pulmonary

17 function.

18 So, when you talk about the

19 potential causal aspects, these are things

20 that are left out that really drive the nail

21 home about the commonality between ozone

22 exposures in animals and humans. And it is
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1 just missing right now.

2 Another major thing that I just

3 have to -- and I won't give the microphone up

4 until I get done with this for sure -- has to

5 do with there's multiple places in this

6 chapter where it is stated, based upon prior,

7 that ozone can't penetrate more than .1

8 microns in the ELF. And you talk about that

9 everything in the alveolar region, it has to

10 be a cascade of products.

11 The alveolar region is 95 percent

12 surface area of type 1 cells. The surfactant

13 film is at most .02 microns in thickness over

14 those cells. And because when you breath the

15 surfactant cools into areas, it gets down to

16 a monolayer of surfactant. Now don't tell me

17 that ozone can't get through that and directly

18 react to the tissue. This is a greatly

19 misconceived statement here about what can go

20 on in these layers.

21 The other thing is, when it comes

22 to the mucous layer, there is no discussion in
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1 here because of the fact that the cilia beat

2 at 1200 beats per minute, you have

3 instantaneously mixing of the periciliary

4 layer. And so, there is the capability of

5 ozone to penetrate to the tissue, not as much,

6 clearly, and that is reflected in the net dose

7 patterns versus the tissue does patterns.

8 So, this has got to be changed in

9 here because it just doesn't flat meet with

10 the physiology, and it doesn't meet with the

11 statements in terms of where the regions of

12 effects occur and how the tissue could be

13 getting exposed to ozone.

14 I have to take, also, exception on

15 page 15, where it says that the models are

16 limited because they don't take care of the

17 URT. When we published, and Jim has done the

18 same thing, the doses normalized to the

19 micrograms per microgram of ozone entering the

20 trachea. So, all you have to do, if 50

21 percent is taken out on the head, and you are

22 exposed to 200 parts per billion, that says it
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1 is 200 divided by 2 is 100 parts per billion

2 got to the trachea. And you now go to our

3 dose curves and you multiple those results on

4 the Y-axis by 100, and you have the dose. 

5 That is not a limitation at all. And what's

6 more, you have now the uptake information for

7 rats, for guinea pigs, for rabbits.

8 So, I have to take issue with this

9 because Gerrity also showed the human uptakes

10 in that. So, this goes again at the issues

11 about statements in here how you can't do

12 interspecies dosimetric comparisons. You want

13 to give me a contract? I will do them for

14 you. It is just not true.

15 There is another one in here, and

16 I will get down to the last couple. It

17 relates to the statements about why uptake

18 can't be related to functional changes, and

19 that the FEV1 breaks down. I brought this up

20 in previous reviews, and I guess, until I

21 dictate it into the record, it won't get

22 through.
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1 John Overton and I published in

2 1996 in terms of the influence of the

3 expansion of the conducting airways on

4 delivered dose. And we showed in that paper,

5 if you selected subjects in clinical studies

6 using the anatomical dead space, you would

7 normalize for dose. And, in fact, Jim Ultman

8 has done work like that and showed that you

9 get a much more reproducible response.

10 And so, some of these aspects of

11 statement about correlation of what you can do

12 and what you can't do are just not really

13 looking at the literature and the information

14 that is available.

15 There is another one last point. 

16 That has to do with the Kim publication. In

17 the homology part there, it is discussed about

18 the GSTM one, and you go on for a couple of

19 pages. But that article isn't cited, and that

20 article showed that the GSTM one has no role

21 in modifying the effects of neutrophilic

22 inflammation at environmental exposure levels.
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1 And so, you go on describing what

2 is going on in terms of other studies, and,

3 then, you get down and don't even include the

4 chem work showing this is not an issue. And

5 it was one of the specific hypotheses that

6 they tested, along with the specific

7 hypothesis that they state a priori in their

8 study was: we are interested in the effects

9 after 6.6 hours of exposure to ozone compared

10 to control. They didn't say they want to

11 study every possible linear combinations along

12 the hours as they went, which was alluded to

13 earlier today.

14 So, these are some of the things,

15 and I have a lot more written up in specifics. 

16 But some of the aspects that really on this

17 next revision need to be taken into account,

18 and in that regard, some of the things -- the

19 greatest influence of exposure dose is

20 exercise, and exercise is not really brought

21 out here as a factor. You talk about

22 children. You talk about age. And, yet, that
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1 is why the studies and the clinical went to

2 the longer hours and the higher levels of

3 exposure, okay, because it is a function of

4 dose and it is nonlinear.

5 And we can show proportionately

6 that you get a tenfold increase in dose when

7 you double the tidal volume. It doesn't go

8 up. And there is a statement in here that

9 current thinking is that it is directly

10 proportional. It is not.

11 And what's more, because the lungs

12 are set up to fast deliver oxygen to the lower

13 respiratory tract, there is less taken out in

14 the trachea bronchial region and more taken

15 out in the lower region. And as you increase

16 the dose, you get a twentyfold increase to

17 those areas.

18 So, these are the kinds of things

19 that are available from published studies,

20 some of them modeling, some of them

21 experimental, also showing in terms of the

22 human uptake studies that, to me, have escaped
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1 inclusion at this point.

2 And I'll stop there.

3 DR. SAMET: And your final grade?

4 (Laughter.)

5 DR. MILLER: My final grade? It

6 is a good start.

7 (Laughter.)

8 You did an excellent job of

9 describing how these other factors affect the

10 ozone uptake. That discussion and review of

11 the literature was very good. But you go weak

12 on saying that you can go between species, and

13 the species homology is a very weak section. 

14 It can be strengthened more.

15 Good God, I mean you can look at

16 the Tepper studies. What you can do in

17 animals you could do in humans. And they come

18 up, and guess what? You have attenuation of

19 pulmonary function, but when you open up the

20 animals, you have more serious lesions. They

21 progress.

22 And this whole time together of
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1 the causality and the information needs to be

2 woven together, and it is not done to the

3 extent that it can be done in this particular

4 version.

5 DR. SAMET: I think just to

6 elaborate on Fred's comments about the

7 dosimetry and the historical development of

8 models, I think you face a dilemma which comes

9 up here and elsewhere as to whether you start

10 from the beginning of the story or you start

11 at a temporally-arbitrary point in time

12 defined by when the review cycle happens to

13 come up.

14 And I think maybe what you are not

15 doing, and I think it is something that Fred

16 alludes to here, and comes up elsewhere, it is

17 not clear exactly sort of what part of the

18 rest of the movie you are not telling us about

19 and why. I think if these links were there,

20 then it would be clear that there was this

21 major foundation of work in ozone and other

22 gas dosimetry that is well-known. You know
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1 it. I think the question is, in terms of

2 staging the document, how you put this in.

3 And I think this same theme is

4 going to come up elsewhere. And I think what

5 Fred is making clear is, if you are not going

6 to show something, say we are looking at some

7 of the more recent attempts to validate

8 earlier dosimetry models, say so and say what

9 those earlier models were.

10 Joe? I was just going to go

11 around. I will get to you, Mike.

12 DR. BRAIN: I will only add a

13 little to all the things that Fred has had to

14 say.

15 The entire document, it is very

16 encyclopedic. There's lots of references

17 there. And again, I think what is really

18 needed is more critical commentary of really

19 singling out the publications that are most

20 important and are most likely to influence our

21 view of what is an acceptable level.

22 One of the novel things, at least
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1 for me, in this was a section that appeared,

2 a rubric that appeared repeatedly in different

3 sections called recent publications. And so,

4 in a sense, that was nice, to really say what

5 is really new since we have looked at this

6 last time. On the other hand, it is important

7 that that be integrated into the past, as you

8 have just heard.

9 Also, it was very uneven as to

10 whether or not there was sort of a summary in

11 this section called recent publications. 

12 5.1.3.2 said: The studies reviewed are in

13 agreement with previous studies and do not

14 change the dosimetry conclusions of the last

15 document. 

16 So, that was very helpful in sort

17 of a bottom line of all the new material.

18 Other times when there was a

19 recent publication statement, there was not

20 any sort of summary or conclusion. I think

21 that would be helpful.

22 The dosimetry and the mode-of-
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1 action sections are really very, very

2 different. I found myself looking at the mode

3 of actions and seeing, then, how incomplete

4 the epi and the clinical studies were. We

5 really do love pulmonary function. It really

6 is easy to measure the FEV1.

7 But when you look at the modes of

8 action, and particularly when you look at the

9 comparative studies, you realize how many

10 other things ozone does. The airway

11 remodeling, the stuff that was done in non12 human primates, in rats, that Fred has talked

13 about. And I really don't see the clinical

14 studies or the epi studies really following up

15 on some of these key observations.

16 Again, as you know, the FEV1 is

17 really dominated by what happens in large

18 airways. You can have significant changes in

19 small airways or changes in the alveoli, and

20 that may influence the FEV1 very, very little.

21 And again, this brings up the

22 topic of really doing a better job on
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1 comparative dosimetry. It seems to me, in the

2 absence of being able to look at airways, and

3 maybe we will now, HCRT is becoming more

4 sophisticated. I don't know whether there

5 will ever be enough money to apply that to

6 some human populations in relation to air

7 pollution.

8 But it seems to me we really do

9 need, as Judy at the outset said, I think in

10 the ozone area the animal toxicology is really

11 very critical because it tells us about some

12 long-term, progressive, irreversible anatomic

13 changes that aren't always easily detected by

14 the kind of pulmonary function studies that we

15 can do.

16 Another area that I think is

17 really important and is mentioned, but should

18 be given more attention, is the whole

19 phenomenon of adaptation. This is really a

20 very important phenomena in relation to ozone.

21 And as you know, animals that are

22 pre-exposed or animals or humans that see high
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1 levels of oxygen can then be given higher

2 levels of ozone or hyperoxia and have a much

3 reduced level.

4 And I was going to mention this

5 earlier in relation to exposure assessment. 

6 It seems to me, as we characterize exposure,

7 we really need to pay attention to how uniform

8 and steady the ozone exposures are. I can

9 imagine huge differences, you know, if a

10 community lives at a fairly high level of

11 ozone all the time and, then, there are a few

12 little blips compared to a community that sees

13 very little ozone, and, then, suddenly, in the

14 summertime has higher levels. I could imagine

15 the responses being very different.

16 So, it seems to me the whole

17 phenomenon of adaptation, its documentation,

18 and animal studies, really needs to be

19 reflected in our exposure assessment

20 adaptation analysis as well.

21 I agree with what Fred said about

22 the alveoli, and I think it brings up another
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1 area. The whole dosimetry is very complicated

2 because the uptake of ozone varies as we march

3 down through the lung from the nose to the

4 pharynx, large/small airways, and finally, the

5 alveolar region, and the other things such as

6 the mucous thickness or the thickness of the

7 alveolar layer, again, varies considerably. 

8 So, it is very complicated.

9 So, I think that is all I want to

10 add at this point.

11 DR. SAMET: Okay. Jack?

12 DR. HARKEMA: I can't add to much

13 more to what has been said. But I want to

14 just echo a couple of things, but, also, ask

15 the first question.

16 The title, I don't think the title

17 actually reflects what is in the chapter

18 because there is dosimetry and, then, there is

19 mode of action, but in between you have to

20 have response. And it is really a dose

21 response chapter that I see that you have

22 here.
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1 So, I had problems with what you

2 were trying to do with this chapter with the

3 next chapters which have to do with short- and

4 long-term effects because there is a lot of

5 redundancy in here. So, I had a hard time

6 grasping what is this chapter supposed to be

7 doing. Is it concentrating just on dosimetry? 

8 Is it starting to give a prelude to effects?

9 And, then, you throw in the mode

10 of action, which I agree with Fred that that

11 is a nice figure to start with, but I had a

12 hard time, after I got done with that, the

13 whole chapter, I thought it would be a lot

14 more question marks in a lot of other things

15 in that mode of action that would have been in

16 there that weren't in there. And there was no

17 really justification of why you included some

18 things in the mode of action and not other

19 things.

20 So, I would just add to, upfront,

21 say what the purpose of this chapter is and

22 give a little hint to the reader about the
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1 mode of action and the link between the

2 dosimetry. I do think you have a lot of

3 responses in here and effects, and dosimetry,

4 if you want to include that in your

5 definition, the dose response relation, then

6 just say that upfront.

7 The other thing is you talked

8 about summary. Summary, this is the shortest

9 summary that I have ever seen for all the

10 information that you gave us there. And I

11 think, of all the chapters, this one, if you

12 are going to have mode of action, that summary

13 has to be an explanation of why you came up

14 with that mode of action.

15 You could spend a lot of time

16 talking about, well, based on all of this, the

17 dose and the response, this is, we think, the

18 mode of action. But it is really cursory and

19 it really needs to be expanded.

20 And, then, you throw in at the end

21 the gaps of knowledge. I think the other

22 chapters later on do that, or maybe if they
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1 don't, then explain how it is going to be

2 integrated into your mode of action, or

3 whatever. It is very cursory there, too.

4 And I want to echo what Fred said,

5 but qualify it first. First, I like all the

6 historical things, and especially in this

7 chapter, of all the other chapters, most of

8 the best -- and I am even giving you a

9 compliment here -- but some of the best work

10 in this dosimetry was done a long time ago,

11 and, also, the effects.

12 And there is so much homology

13 between animal and human. What the animal

14 studies are doing is providing a clue of the

15 pathology that is assumed in the human. And

16 actually, there are studies that have tried to

17 get to that.

18 But that is ignored. I mean there

19 is not a lot of emphasis on the epithelial

20 remodeling that goes on there. And if you get

21 epithelial remodeling, you are going to change

22 your thickness.
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1 And the dosimetry is really, I

2 mean the chapter is biased with short-term

3 exposure. Okay? And that is probably because

4 of some of the data, but it should be brought

5 up that this dosimetry could change quite

6 radically if you have repeated exposure. You

7 get a glimpse of that through the pathology

8 that happens. And so, I think that somehow

9 that should be woven in there, if you are

10 going to have this dose response chapter.

11 There were just a few other minor

12 things that I had in here. I would just end

13 with something to think about that maybe you

14 could weave into this that would make the

15 point about where lesions are and where the

16 dose is, and so on.

17 They show that nice figure, and I

18 think it is an appropriate figure, of the

19 terminal bronchial and alveolar duct area

20 where the epithelium gets smaller and you get

21 thinner airway fluid on there. And you get

22 the primary lesion of ozone right in that
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1 center region. That has been verified with

2 dosimetry.

3 On the other hand, if you

4 emphasize the fact that you have a thin -- you

5 know, that the effect is based just on that

6 thin layer there in an exposure, why don't you

7 get deep ozone lesions in the outer

8 parenchyma, where, supposedly, they are more

9 exposed? Well, the simple fact is it is much

10 more complicated than that.

11 And one way to think about maybe

12 organizing this a little bit different is to

13 think about talking about dosimetry in very

14 cursory, the historical, starting with whole15 animal physiology, all the elegant, but doing

16 it a very concise way, and then talk about to

17 the cellular level.

18 And that way, I don't know, the

19 reader, I think it would flow a lot better,

20 instead of starting with the extra -- there is

21 a lot of emphasis just on the fluid and the

22 cell part. So, anyway, that is just the
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1 writer's prerogative.

2 Then, finally, there is not much -

3 - if you are going to do looking about

4 response, there is no mention about

5 differences in response of airway types, which

6 is huge, I think. I think it is really,

7 really important to talk about why some cells

8 respond and others don't. I personally don't

9 think it is just the airway lining fluid that

10 is running the whole show here.

11 So, anyway, that's my comment.

12 DR. SAMET: Okay. Thanks.

13 And before we go to you, Jim, just

14 two comments. I mean I think, one, the

15 comments about the summary again point to the

16 need for getting the summaries right, which I

17 think the point is made.

18 The other thing I think this

19 chapter should be doing, and I think this

20 really comes out in part of what Jack was

21 saying, is it should be laying, in a sense,

22 the biological story out for the human health
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1 effects that are going to be addressed in the

2 next chapters. It seems to me that does

3 involve integrating dose with mode of action. 

4 And if you are going to talk later about

5 incident asthma, for example, or exacerbation

6 of asthma or reduction of lung function, that

7 squarely gets you at this question of what

8 target size within the respiratory tract might

9 be relevant, and what could be the underlying

10 mechanisms of injury that would lead, say, to

11 reduction of lung function? Is that upper

12 airway deposition and triggering of air

13 receptors or effects on small airways with

14 inflammation?

15 I mean I think that is maybe the

16 way. I would appreciate thoughts from others,

17 but it seems to me that is the way the story

18 ought to be coming here and setting up for the

19 next two chapters.

20 Right now, it is sort of here's a

21 chuck on dosimetry and here's a chunk on mode

22 of action. It is not integrated in fact to
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1 set up for the effects, for the discussion of

2 health outcomes at all. You have the mode-of3 action figure that Fred highlights, but it is

4 not brought together.

5 DR. HARKEMA: I think it would

6 help the other chapters later on, too.

7 DR. SAMET: Exactly.

8 DR. HARKEMA: Because you could

9 eliminate a lot of redundancy.

10 DR. SAMET: Yes, that's true. 

11 Yes. But this is where it maybe should be

12 brought together.

13 Jim?

14 DR. ULTMAN: I agree with

15 everybody's comments that there needs to be

16 better justification between the dosimetry

17 part and the mode-of-action parts of the

18 chapter.

19 I think part of the problem is

20 that the dosimetry work that has been taken on

21 in the past kind of ended at the epithelial

22 wall, or even before that, at the gas/liquid
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1 interface. That is reflected by much of the

2 material that you have.

3 You talk about how much dose, how

4 much ozone uptake occurs through the upper

5 airways versus the acinar regions versus the

6 deeper lung. And the uptake of ozone is only

7 the beginning of the story. Then, you talk

8 about how it gets converted into other, could

9 get converted into other byproducts that are

10 toxic to the epithelium. And that is kind of

11 where we are now. And things have kind of

12 stopped at that point.

13 So, dosimetry really hasn't

14 progressed so that it can be connected up with

15 the mode of action because we don't have

16 models and we don't have experimental data

17 that does that.

18 So, I think part of the chapter

19 reflects kind of a dead-end in where we are in

20 dosimetry relative to the biological effects. 

21 But I think you could put an introduction in

22 the beginning, and you could bridge the two
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1 sections and make them clearer.

2 I think that -- there are two

3 sections in the chapter on reactions of ozone

4 in the substrate -- I'm sorry -- in the ELF

5 with various substrates. There are two

6 sections.

7 The division between what material

8 goes in one section versus what material goes

9 in the other section is not clear. One of

10 these reaction sections is in the dosimetry

11 part. One is in the mode-of-action part. It

12 is not clear what is different between them. 

13 They seem to be somewhat redundant.

14 And I had some suggestions in my

15 comments that maybe you can somehow take the

16 first section and focus it more on the kinds

17 of modeling and measurements that have been

18 done to reflect on the penetration of ozone

19 into the liquid lining layer, how much of it

20 can really reach the epithelial surface.

21 You have already got material on

22 the reaction rates that occur in ELF. Maybe
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1 talk a little bit more of the state-of-the-art

2 and what we know about these reactions. But

3 kind of move it away from the mechanisms of

4 the reactions because I think that should go

5 in the mode of the action. You know, the

6 mechanisms by which ozone combines with

7 antioxidants versus other compounds maybe

8 should go in that second section.

9 So, I think you need a clearer

10 division between those two, and that may help

11 bridge things a little bit more because it may

12 show how dosimetry ends at one point and,

13 then, it gets picked up by mode of action at

14 another point.

15 Maybe a figure would help in that

16 regard where you show a continuum. You know,

17 you inhale ozone. It gets distributed into

18 the lungs. It gets absorbed into the ELF,

19 reacts in the ELF, goes on to the tissue, et

20 cetera, et cetera.

21 And, then, the first part of the

22 chapter focuses on this part of the process. 
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1 The second part is on this part, and we are

2 missing a middle part that we just don't know

3 at this point, so we can't say anything about

4 it. But that may be a way of putting the

5 whole thing, I think, in context.

6 Again, I think what Fred mentioned

7 about the factors, you know, convection,

8 diffusion. I agree with what Jon said that to

9 go into that in a lot of detail in a document,

10 in an area where we are creating these

11 criterion documents, is very advanced now, is

12 very sophisticated. To go back to square one

13 and talk in length about some of the

14 principles maybe seems like you are taking a

15 step backward. But, again, maybe a figure

16 would help.

17 And I think Fred, in an earlier

18 publication you had, it showed up like a

19 profile, remember, of the different mechanisms

20 and different parts of the lung. Do you know

21 which figure I am talking about? I think that

22 would be well-placed.
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1 You wouldn't have to talk much

2 about the principles. At least show how the

3 principles impact on the various factors. 

4 Okay.

5 I think there is a weakness in the

6 chapter in your ability to connect the various

7 factors in breathing that are affecting

8 dosimetry. Because you talk about, well, when

9 you increase frequency, this happens to

10 uptake. You say there is not much known about

11 the effect of minute volume in uptake.

12 But these factors are connected. 

13 Within the particular situation you are in the

14 factors are connected. For example, you show

15 a figure that happens to be from one of my

16 papers, Figure 5.3. I have got it in my

17 writeup.

18 Oxygen uptake efficiency among

19 different subjects decreased with increasing

20 breathing frequency. That is what that shows. 

21 What you don't say is that the minute volume 

22 is being held constant, essentially. The
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1 subjects have been coached to look at a

2 constant minute volume.

3 Do you understand what I am

4 getting at? So, it means nothing to say the

5 frequency is increasing unless you know what

6 happens to the minute volume.

7 So, that happens at several

8 different places. And I think it is really

9 important to be able to discipline yourself

10 to, when you say this changes, but this is

11 held constant, or this has changed and the

12 subjects were at liberty to do whatever they

13 wanted with the other two, so I think that is

14 important to do. Otherwise, you get the wrong

15 idea.

16 In fact, I think the idea of

17 frequency, increases in frequency with

18 exercise, giving you more penetration of the

19 ozone into the lung, and therefore, more

20 damage to the lower airways, bias in damage,

21 do you remember that statement that is in

22 there or not? You have that statement in
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1 there.

2 Higher frequencies, I think you

3 actually have it in Chapter 2 also. 

4 Increasing frequency because of exercise will

5 drive ozone deeper in the lung. Well, it is

6 not the frequency that really does it. It is

7 the tidal volume that is doing it. You know,

8 when you have a greater minute volume demand,

9 then you need to increase your tidal volume

10 somewhat.

11 So, I am not trying to give you a

12 lecture on dosimetry, but these are various

13 things that are kind of mixed up in the

14 chapter.

15 (Laughter.)

16 Again, I have notes on this.

17 The other thing that I wanted to

18 go onto, I think this is the last thing I

19 really had to say. I think exercise, physical

20 activity, you have a section called physical

21 activity. It is very important, obviously, to

22 the whole process of risk assessment because
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1 it is built into the exposure modeling, and it

2 is going to be a factor in determining what

3 the risk is because many of the measurements,

4 at least the controlled human measurements,

5 are made under specific exercise conditions. 

6 And we know that when you change the exercise

7 condition, that will change the response.

8 But in this chapter you say

9 nothing about how exercise affects breathing

10 pattern. So, on the one hand, you say how

11 certain factors change the dosimetry picture,

12 but you don't say how those factors change

13 during exercise. And it is not uniform. When

14 you increase exercise, frequency and tidal

15 volume don't change simultaneously.

16 If I have got it right -- and the

17 respiratory physiologists in the room will

18 straighten me out -- I think when you go from

19 low levels of exercise to moderate level, you

20 may know this, too, I am not sure. When you

21 go from low to moderate, I think the frequency

22 goes up fast.
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1 DR. MILLER: Only two or three

2 breaths' increase.

3 DR. ULTMAN: Pardon me?

4 DR. MILLER: Only two to three

5 breaths' increase.

6 DR. ULTMAN: The frequency

7 increases --

8 DR. MILLER: The frequency only

9 goes up two or three.

10 DR. ULTMAN: The frequency goes up

11 first, I think.

12 DR. MILLER: Yes.

13 DR. ULTMAN: And, then, when you

14 get up to higher levels of exercise, the tidal

15 volume starts going up.

16 So, it is more complicated than

17 just saying, well, the minute volume increases

18 with exercise; therefore, you get a bigger

19 dose. Because depending on how these

20 different factors change, it will affect the

21 nature of how the dose changed.

22 So, what I am suggesting is to put
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1 in some very short paragraph discussing the

2 relationship between breathing pattern and

3 exercise. You don't have to go through a lot

4 of detail, I mean, but just how does the

5 breathing pattern change during exercise.

6 Based on your examination of the

7 various factors, how various factors in the

8 breathing pattern affect dose, now when people

9 change exercise, how do we expect these

10 various breathing pattern changes now to

11 affect the dose? You have done a little bit

12 of that, but I think you can go beyond that. 

13 And it will be helpful, I think, in the risk

14 assessment to know some of these things.

15 DR. SAMET: Okay. Mike?

16 DR. FOSTER: I just want to give

17 Jim Brown a little bit of a break here.

18 (Laughter.)

19 You know, Fred, Gary Hatch, Tim

20 Gerrity, Jim Ultman -- Jim Ultman and Tim

21 Gerrity have done all the human dosimetry data

22 with ozone. There isn't anybody else. And
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1 that work has stopped. Okay?

2 And that work did not consider

3 gender differences in a large way or with a

4 designed experimental way, or ethnicity

5 differences. And we know now that they seem

6 to be factors playing into it.

7 In terms of the animal model

8 stuff, in terms of some of the programs you

9 were involved with, Margaret Menache, Gary

10 Hatch, it was all done, basically, with guinea 

11 pigs and rats.

12 The biggest model -- and Steve, I

13 think, and Jack will confirm -- the biggest

14 model studies that have come over -- and, Jim,

15 in deference to Jim Crapo and Mercer and you,

16 Fred, those mechanistic models are 25 years

17 old. And over the last three decades, the

18 mouse model has taken over, a tremendous

19 amount of work.

20 There is not a single study done

21 on dosimetry of ozone in the mouse that I am

22 aware of. The best aerosol work was done by
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1 Loveless 40 years ago. And you know this.

2 So, the rat models are good, yes,

3 to a certain --

4 DR. MILLER: And there's no reason

5 that Gary Hatch can't do the mouse now.

6 DR. FOSTER: Pardon?

7 DR. MILLER: I say there is no

8 reason Gary Hatch can't do the mouse now.

9 DR. FOSTER: Well, we are not

10 talking about --

11 DR. MILLER: It goes back again to

12 my point.

13 DR. FOSTER: -- research

14 initiatives here. We are talking about

15 critiquing.

16 And I just think that it is a

17 little difficult to start saying things about

18 dosimetry when the biggest mechanistic models

19 are the mouse, and there is no data.

20 So, I think you have to take a lot

21 of things into consideration here.

22 DR. SAMET: Okay. Good. I have
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1 enjoyed the catchup on the story here.

2 I just want to make sure -- we

3 have spent a lot of time on this chapter. I

4 think we have probably covered most of the

5 major points, unless Judy has one more.

6 DR. GRAHAM: I will be very quick. 

7 Most of my comments have been voiced.

8 I will begin with the easy one. 

9 On page 5-62 there is this figure of potential

10 mechanisms. I mean, in detail, I could say,

11 well, define acute versus chronic, but I guess

12 I am pretty much troubled by parts of it. 

13 Even if I say that it doesn't matter that the

14 immune system is not in color, but, for

15 example, there is a dotted line between immune

16 system modulation and decreased pathogen

17 clearance and impaired host defenses. Well,

18 to me, if you have decreased pathogen

19 clearance, you are going to have impaired host

20 defense. It is a straight line.

21 So, I mean I could talk for five

22 minutes about this figure, I won't. But that
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1 is an indication of, I think, whenever you try

2 to do a schematic that is oversimplified,

3 somebody is going to come along and say it is

4 too oversimplified. Who would that person be?

5 The other item I have, and this is

6 where I might disagree a little bit with some

7 of my colleagues, I was quite concerned about

8 the incorporation of MOA here. And I was

9 concerned at two levels.

10 One, it was confusing. There was

11 a lot of effects there, and there has to be. 

12 An MOA of what? So, you have to state an

13 effect.

14 But there were some papers there,

15 effects, that were not in the effect chapters. 

16 And there were some things in the effects

17 chapters that I thought could have been over

18 here in the MOA.

19 So, this is more than just an "Oh,

20 gee, you missed a reference" thing. It was

21 interrupting the story. So, to me, the MOA

22 that should stay here is the MOA related to
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1 dosimetry. So, what might happen with the

2 fluid lining layers, that kind of thing would

3 be here. But when you get to MOA of pulmonary

4 function, MOA of inflammation, I think that

5 should be incorporated with the discussion of

6 that effect. And, then, that way, you would

7 have the story all in one place.

8 DR. SAMET: And I will say I think

9 this is what I was trying to touch on in my

10 comments. I think this could be a chapter

11 where you do that, but you would have to make

12 a different chapter than it is now.

13 And I think maybe Judy's point is

14 that, without some form of integration around

15 the health effects, either here or somewhere,

16 you are not serving the needs of what will

17 follow when you discuss the observational and

18 other experimental data.

19 And I think we have highlighted

20 this for you, and I think you really need to

21 think through a solution, because it will be

22 critical in laying the foundation for
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1 interpretation of what follows.

2 Let's see, any other comments?

3 (No response.)

4 We have actually lavished an

5 extraordinary amount of time on dosimetry. I

6 think this is what happens when you put one,

7 two, three, four, five people, or something

8 like that, in the room who care about

9 dosimetry.

10 (Laughter.)

11 And I think they all have a

12 somewhat different view of the past.

13 (Laughter.)

14 But I think we certainly

15 highlighted the major issues for the chapter

16 for you, I think.

17 Is that a finger? Yes?

18 MS. WALSH: Yes, I just want to

19 point out that in the ISA, since we have been

20 evolving, we have used a mode-of-action

21 chapter somewhere towards the beginning

22 separate than the effects chapter. So, this
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1 is the third time I have kind of used this

2 model, and it was well-received in the last

3 two documents.

4 (Laughter.)

5 And, yes, we can reduce redundancy

6 between the effects mentioned here and the

7 effects mentioned elsewhere. Sure, that is

8 very doable.

9 But this is the model that has

10 evolved over the past couple of ISAs.

11 DR. SAMET: But the point really

12 is that you want to be able to, as you

13 interpret the evidence, be able to go very

14 clearly to where you have laid sort of the

15 biological foundation of plausibility. I

16 think right now what you have is just not

17 going to serve that purpose very conveniently.

18 I think what we are saying is think about how

19 to do that.

20 DR. GRAHAM: With plausibility in

21 one chapter and the outcome in another

22 chapter, you have to remember an awful lot.
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1 DR. SAMET: So, I think we

2 appreciate your dilemma. Solve it.

3 (Laughter.)

4 Anybody on the phone want to

5 weigh-in? Chris? Kathy?

6 DR. WEATHERS: No, nothing for

7 anything.

8 DR. SAMET: Okay. Okay, thanks.

9 So, what I am going to do, this

10 may not work out, but I am going to suggest

11 that we move on to the question 7, which is

12 the short-term exposure. I know that perhaps

13 this discussion could be lengthy. If it

14 becomes real lengthy, we will take a break in

15 the midst of it.

16 But why don't we get started on

17 question 7, Mike?

18 Oh, wait. Wait, wait. The lead

19 discussant, Fred, you were so eloquent that I

20 think you should be the writer here.

21 DR. MILLER: Only if everyone

22 sends me, particularly Jim his comments, and
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1 Joe and Jack. And I will integrate them, and

2 we will get a draft out to you.

3 I think Jim, as usual, provided

4 you a way forward with his recommendation on

5 how you could restructure this, I think.

6 DR. SAMET: Okay. Thanks.

7 Mike?

8 DR. FOSTER: So, I am going to

9 just make some brief comments because I am

10 sure there's a lot of people that will weigh11 in.

12 This is an immense chapter that

13 was prepared similar to Chapter 3 in terms of

14 breadth. It is 170-some pages of text, and

15 not counting 20-some pages of references. So,

16 it is just immense.

17 It covers acute chamber exposures

18 in humans, some toxicity in animal models,

19 and, then, it drifts into some epidemiology

20 studies. So, I really do not have the

21 expertise to comment, but there's plenty of

22 other people that can comment on the
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1 epidemiology aspect.

2 I think I would just like to

3 keynote one or two items. And that is the

4 fact that, for the plant biologists here,

5 FEV1, you have heard what that stands for is

6 the forced expired volume in one second. So,

7 that means if you inhaled as much as you

8 could, and you exhaled as hard as you could in

9 the first second, how much volume comes out,

10 with the reflection of how much you actually

11 had taken in entirely and exhaled.

12 So, that is what that FEV1 means. 

13 It is a reproducible measurement. As Joe

14 alluded to, it doesn't tell you a lot about

15 where the problems are.

16 But with ozone exposure, actually,

17 the counterpart, the amount of air that you

18 can actually take in is driving the changes in

19 FEV1. That has been shown several times over. 

20 So, it is not all airflow

21 obstruction for using this metric. But what

22 that metric has shown, if you look at the
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1 FEV1, is a dose response. Now, as Joe said

2 earlier, the elephant in the room is, where is

3 the threshold and what is the background level

4 of ozone, and that what gets added to that by

5 anthropomorphic activities? So, we are not

6 sure where exactly that threshold is. But as

7 you increase levels of ozone, FEV1 in chamber

8 studies shows decrements.

9 The other important point that

10 goes on with chamber studies is the fact that

11 you could call it a dichotomous or a binary

12 kind of response. No matter what group levels

13 you look at, there are high responders and

14 there are low responders.

15 And that could be due to a lot of

16 different factors. It could have to do with

17 diet, closeness to the highway, what your

18 grandmother may have done, what your mother

19 may have done, and where they lived. So,

20 there's lots of new activity going on trying

21 to explain why there is a binary response to

22 ozone.
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1 There are questions that are now

2 arising about ethnicity in terms of

3 sensitivity for that binary response.

4 So, I think I will just stop

5 there. I will just add one thing. The one

6 comment, Jim, that I had on the chapter was

7 the fact about there is a well-known, well8 characterized obesity component. And that has

9 all been demonstrated in the mouse models,

10 primarily by Stephanie Shore's laboratory at

11 Harvard.

12 But all the studies in humans have

13 been retrospective analyses done either by

14 Bill Bennett or Bill McDonald on archived data

15 acquired at UNC. And I don't think the data

16 is at all strong. It is all retrospective. 

17 I think there are current studies going on

18 presently.

19 So, I think, Jon, that is where I

20 would like to pull it off there.

21 DR. SAMET: Okay. Thanks, Mike.

22 Jim?
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1 DR. ULTMAN: Yes, I just had a

2 couple of comments.

3 First, I want to commend the

4 authors. This was a bear of a chapter to put

5 together. I can see that. There is a lot of

6 information in there.

7 And I thought the writing was

8 really good. I don't know who wrote it. Was

9 it written by more than one person? Yes,

10 well, they were good writers. I really

11 appreciated it.

12 First of all, I think a key figure

13 in this chapter is Figure 6.1, the one that

14 compares the low ozone concentration data to

15 the McDonald model. I think it is important

16 to go into more detail about the McDonald

17 model, exactly what data were used to validate

18 the model. It might even pay to put an

19 equation in there and explain. I know it is

20 a complicated equation, and it appears in the

21 exposures and the risk assessment planning

22 document.
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1 But I think it would pay to put

2 the equation and explain the elements in the

3 equation, so that it is clear what factors

4 affect that dose response and what data was

5 used to validate it because it is going to

6 become a key point, I think.

7 And I may be naive, but it also

8 begs the question, I think, of where there is

9 a threshold, if there is a threshold or not

10 when you look at that data. I don't know. 

11 You don't discuss it all in the chapter. You

12 don't say anything about whether that plot and

13 that data somehow indicates that there is a

14 threshold. You don't conclude about that

15 anywhere in the chapter.

16 DR. BROWN: I was just going to

17 say that all I said was that there was a

18 smooth dose response curve --

19 DR. ULTMAN: Yes.

20 DR. BROWN: -- down to about 40.

21 DR. ULTMAN: Yes, right. Right. 

22 Okay. I don't know if it is possible in this
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1 chapter to make some kind of a speculation

2 based on that data in the model. I guess the

3 model is smooth, but I don't know if you can

4 say anything about it.

5 But I do know, when we did the

6 reconsideration, there was a couple of places

7 in the documents that it said there was no

8 threshold. So, this document maybe should

9 take a look at that, and take a second one.

10 And, then, there is another issue

11 that I think is going to come out in the risk

12 assessment that I am sure we will talk about

13 later. And that has to do with the use of,

14 you know, what we use as a reference point to

15 be able to estimate risk. Because, clearly,

16 in the real world you have to use some kind of

17 a background, a real background, as a

18 reference point. You know, whatever the PRB

19 is, somehow in your risk assessment that has

20 to be used, and I think it will be used, to do

21 the risk assessment.

22 But in this laboratory data that I
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1 am talking about, the controlled human data,

2 there is at least one place in the chapter,

3 maybe more, where you talk about the ozone4 induced response, is it? Which means the

5 response of ozone pre- to post- in a chamber

6 exposure relative to the change in response

7 when breathing clean air in the chamber. So,

8 it is a double-delta. It is a delta pre- to

9 post- with ozone minus the delta pre- to post10 with clean air.

11 Now the problem is with clean air

12 in many experiments, maybe most of these

13 chamber experiments, when a person is

14 exercising with clean air, with filtered air,

15 their pre- to post- values of pulmonary

16 function measurements like FEV1, they are

17 actually improved. So, instead of a decrement

18 because of exposure to clean air and exercise,

19 actually, you get an increase. So, a person's

20 function is better because of the exercise.

21 So, now when you do this

22 delta/delta, what that does is it exaggerates
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1 the effect of ozone because you are taking a

2 decrement, and from that, you are subtracting

3 a minus decrement, essentially. So, it

4 exaggerates that effect.

5 Now in the risk assessment, that

6 will be taken care of; I realize that, because

7 the referencing will be done relative to the

8 effect of the policy-relevant background.

9 But this chapter doesn't talk

10 anything about that. You know, it points out

11 that there is this ozone-induced dose, and

12 then it goes on to quote results from

13 experiments on the basis of a pre- to post14 ozone exposure dose, which is different. That

15 is clear that those are different things.

16 But you don't compare them at all. 

17 I think one sentence in the chapter says

18 something about it, but I think it is such an

19 important issue. If you can spend a little

20 bit more time on it, and even stretch it to

21 putting in some information on what the effect

22 is of just breathing clean air and exercising,
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1 in other words, what happens in studies,

2 because the data is available.

3 And I think it is important to

4 know what the magnitude, to kind of get an

5 idea what is the magnitude of that beneficial

6 effect of exercise, if you will, and breathing

7 clean air, what is the magnitude of that

8 relative to being exposed to a small level of

9 ozone which creates a decrement that kind of

10 offsets that. How big are the relative sizes

11 of those two effects?

12 So, again, this is not to direct

13 you to draw any conclusions, because I think

14 that is going to be done in a risk assessment

15 in terms of how important these effects are

16 and how they impinge, you know, correcting

17 them to be able to calculate.

18 But I think in the chapter you

19 need to lay the groundwork by having some of

20 the information there, so people understand

21 when you read the risk assessment document why

22 they did what they did.
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1 That's it.

2 DR. SAMET: Okay. Thank you.

3 John?

4 DR. BAILAR: I have three points

5 to add.

6 First, and most important, it

7 appears to me that the evidence for mortality

8 as a result of short-term exposure to ozone is

9 stronger than likely. It is compelling.

10 I am not trying to separate the

11 effects of mortality displacement from longer12 term effects. I am not trying to separate PRB

13 from anthropogenic sources. But, overall, I

14 find it hard to escape the conclusion that

15 short-term ozone exposure is sometimes lethal.

16 This view of mortality is guided

17 by two broad principles. First, there can be

18 no heterogeneity in effects, whether it is

19 interreaction, synergy, effect modification,

20 what have you. There can't be heterogeneity

21 unless there is something to be heterogenous. 

22 There has to be some kind of an effect to be
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1 altered in at least some subset of the study

2 population.

3 And the second pillar of this

4 conclusion is that any mortality effect cannot

5 be zero overall if there is an effect for some

6 cause, however minor, or for some set of the

7 population, however small, unless there is a

8 compensating effect in the other direction for

9 some other cause of death. And I have not

10 seen any evidence here suggesting that ozone

11 exposure is protective against any lethal

12 disease.

13 These principles hold even if

14 overall mortality cannot be shown to be

15 elevated, cannot be shown directly to be

16 elevated. An effect can be real, but too

17 small or too complicated to be evident in

18 overall mortality or even in broad categories

19 of causes of death.

20 It may be that EPA is really

21 asking whether the all-cause mortality data

22 alone show an effect, rather than whether a
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1 broader view shows an effect. I agree that a

2 narrow view of all-cause data supports that

3 phrase "likely to be", but the broader view

4 seems to me to leave no room for doubt.

5 My second point, briefly, is that

6 the epidemiologic findings of increased

7 overall mortality are quite remarkably

8 consistent in direction, though not in size,

9 consistent over space, time, and a wide range

10 of circumstances and study types, despite a

11 few exceptions for single cities or other

12 subgroups. And I think that this might be

13 made a stronger point in this chapter.

14 Third, I would like to see a table

15 showing, for each of the short-term mortality

16 studies considered, the crude effect and the

17 effect after adjustment for PM and any other

18 factors in the reported study.

19 In my experience, when adjustment

20 for confounders reduces a crude estimate of an

21 effect by a substantial amount, more and

22 better information about confounders, et
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1 cetera, including additional items, is likely

2 to lead to a further reduction, possibly down

3 to zero. If the initial adjustment has little

4 effect, using more items and better data is

5 not likely to have much effect.

6 The limited information on this in

7 the present report suggests that co-pollutants

8 and other confounders do account for some, but

9 not all, of the relation to ozone measures in

10 the crude measures of mortality, but I would

11 like to see this laid out in a table.

12 That's all.

13 DR. GRAHAM: Okay, I have a couple

14 of major comments with regard to this chapter.

15 First of all, I only skimmed the

16 epi part. So, I kind of took it on faith the

17 epi was correct, and I figured that you guys

18 would take care of it, so we could all stand

19 in a circle and point.

20 (Laughter.)

21 So, I think that, with that

22 caveat, I think the causation statements are
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1 very well supported scientifically. I think

2 that many of them have been well-established

3 for many years.

4 But this answer leads to key

5 questions, and especially for susceptibles

6 that require more attention in the text;

7 namely, what exposures are sufficient to cause

8 the effects of interest and what is the

9 severity of the effects at these effective

10 exposures?

11 Now I am sure, like I say,

12 somebody could point, well, this line and that

13 line, but you have to hunt and you get so

14 buried; it is very hard to figure it out.

15 I think the epi studies are easier

16 to interpret because a hospital admission is

17 a lot clearer in terms of severity than is a

18 morphological change in a rat or a small

19 change in FEV1 in humans.

20 I would say another point here,

21 with rare exception of some of the epi tables,

22 the tables are wholly inadequate. And there
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1 is a reason for this. They don't exist.

2 If you go and look at this, the

3 data presented very unevenly. Like some of

4 the summaries of the old human data, it says

5 this and that happened. It doesn't tell you

6 what concentration, what duration, and whether

7 there was exercise. Even with some of the

8 more recent studies that are described, you

9 don't know what the exercise level was.

10 For some of the animal studies --

11 this is an acute session -- some of them are

12 90 days. And, then, you go over to the

13 chronic chapter, some of those are 90 days. 

14 I mean you could make a decision one way or

15 the other, but in some cases you don't know

16 how long the animals were exposed, whether it

17 was one day or one week. For some studies you

18 do know.

19 So, there is no consistency of

20 presenting this information that is definitive

21 in terms of how should you even interpret it. 

22 With a lot of human clinical studies, it
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1 doesn't even indicate whether they had

2 exercised, much less to say whether it was

3 light, moderate, or heavy.

4 There is an answer to this, and

5 the answer is tables. And in my

6 recommendation, probably one of my strongest

7 recommendations would be to go back to your

8 old tables in the 1996 document and in the

9 2006 document. And the reason I say that is

10 because for some of these things I went

11 hunting and there were actually references

12 missing, important references in my view, from

13 the 2006 document that were in the 1996

14 document.

15 So, I think if you kind of like

16 had word processing people pull those tables

17 together, and then add the new studies, you

18 would have everything in one place. You

19 wouldn't need to put all these details in the

20 text. You could use words like one-day

21 exposure, acute. You could use little

22 subterfuges like that because a person could
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1 go look at the study.

2 Sample sizes used in the human

3 clinical studies, these things become

4 important. And actually, the only way you can

5 find them is to look in the old documents.

6 Another point here, there is an

7 artificial separation between the old and the

8 new studies and the MOA and effects. These

9 two major artificial separations lead to a

10 choppy presentation and weak integration.

11 I think it really concerns me

12 because we are basing the standard on health

13 risks, not on health risks that were

14 discovered since 2006. And to simply have two

15 paragraphs from 1970 to 2006, and then have 10

16 pages on something later, you don't get a gist

17 of it.

18 So, I think that each document

19 needs to be standalone. But it doesn't get

20 standalone simply by getting taller and

21 taller. That is why I think the tables can be

22 a good way to manage all the data.
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1 So, you could put, let's say, five

2 animal studies looking at lung remodeling. 

3 Fine. Talk about one of them in general, but

4 say, "Go look at the table for the five

5 studies." So, there's ways to do this without

6 artificially separating it.

7 And now my personal favorite about

8 the artificiality of this is Bob Devlin's

9 study, humans exposed to ozone, and he looked

10 at alveolar macrophage function. You've got

11 like one line, two lines. You didn't know

12 what the concentration was, didn't know the

13 exercise, but, boy, there's three or four

14 lines there about effects of ozone on alveolar

15 macrophages in marine toads. Okay? That is

16 my favorite.

17 I'm sorry. I couldn't help it.

18 (Laughter.)

19 Then, as another main point, the

20 animal toxicological studies on respiratory

21 and morphological morphometric changes are not

22 adequately discussed. And I mean that is the
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1 polite way in writing. It is like it is

2 pitiful how little discussion there is on

3 them.

4 When they are mentioned, the

5 discussion is buried, too brief, does not

6 allude to supporting evidence, and does not

7 discuss implications to severity effects in

8 humans.

9 There's dozens of references to

10 effects below .5 ppm down to .15 and .2 ppm in

11 non-human primates that are not included. I

12 mean this is all pretty relevant stuff, and it

13 contributes to the story of what might be

14 happening.

15 I mean inflammation has a whole

16 story to it, not just what is discoverable in

17 humans. I mean here in the animal studies

18 inflammation has been more linked to parallel

19 sorts or even consequential sorts of

20 morphological changes.

21 And I think this whole story of

22 lung structural changes is important in
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1 understanding severity in humans. So, it

2 contributes a lot.

3 And, then, I think I will just

4 pick one or more. Okay, on page 67, there is

5 a discussion of the Slagle studies, the 2009

6 study. That is the human clinical study that

7 goes down to 60 ppb. So, it is really

8 important.

9 And it says that there are no

10 statistically-significant group effects. But

11 I have a question here. Did EPA evaluate the

12 quality of the statistics in this paper? Did

13 the study have adequate power to detect

14 effects? What exercise levels were involved?

15 And so, this is an indication

16 that, to me, it is a pretty doggone big deal

17 about a study at 60 ppb. Like I think another

18 three or four sentences would have helped the

19 reader say, "Wow, this is important" or "Who

20 cares?"

21 I have a question about the

22 Slagley 2009 paper and the Adams 1998 data. 
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1 It says that the data are unavailable to EPA,

2 and they provide the reason for the Adams 1998

3 data being unavailable. And apparently, Adams

4 published some of that 1998 data in a

5 subsequent paper which was available. But it

6 doesn't talk about the reason for the Slagley

7 studies not being available to EPA.

8 And this is just something -- food

9 for thought. How does this jive with the

10 Information Quality Act if the data are not

11 available?

12 Oh, yes. Okay, I do have to say

13 one thing about missing references. The text

14 says in one line about the animal studies,

15 "Levels as low as .08 have caused effects on

16 infectivity." There's not even a reference

17 there.

18 Some of this is close to heart

19 because the man that hired me into EPA, his

20 name was Dave Coffin, and he did those studies

21 way back when. And those mouse infectivity

22 studies were they found effects at .8 ppm. A
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1 fellow by the name of Fred Miller replicated

2 that work several years later. So, this is

3 pretty low stuff.

4 That paper, that original paper,

5 is what was the basis for the very first ozone

6 standard at .08 ppm oxidants. So, here's this

7 whole rich literature that even drove a

8 standard, and the reference isn't even here. 

9 That is just an example of how the older data

10 is getting dismissed, even though it has

11 values.

12 I have here, too, on page 6-134,

13 this is the CNS effects. It says there is a

14 paragraph summarized in the 2006 air quality

15 criteria document; it is totally insufficient. 

16 And it talks about epi effects with no

17 significant details, calling it adverse. The

18 rodent studies are described in two sentences

19 with no indication of species, concentration,

20 duration, specific endpoints. And so, you

21 can't get a feel of it.

22 In some cases, here is new work. 
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1 There is a section, potential relationships

2 between relevant ozone exposure of rats and

3 Alzheimer's. That is a pretty big stretch. 

4 So, when that kind of an association is going

5 to be made, particularly for rats, I think it

6 is deserving of more rationale, more intense

7 effort.

8 So, with that, I do have to say

9 that, having written the animal tox chapters

10 in a lot of the early documents, I do feel

11 your pain. It may not sound like it, but I

12 do.

13 DR. SAMET: So, one comment I

14 think, there is a patchiness that I think has

15 been described already in the comments in the

16 way you provide at least figures for the

17 epidemiological studies and text descriptions

18 that are sometimes lengthy, but still

19 inadequate for the toxicology studies.

20 And I think what you heard, in

21 part, is that those people who understand that

22 literature can't find what they need in the
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1 text descriptions to interpret it. There

2 probably should be supporting tables. I mean

3 a lot of the stuff around page 130-131 is

4 illustrative of the kinds of things that I

5 think you should avoid doing, you know, the

6 paragraphs that start with so-and-so, and the

7 next one is so-and-so. It is just really not

8 helpful.

9 And what you need is a template

10 for capturing what the experimental design was

11 and what the concentrations were at which the

12 experiment was done, and what the outcomes

13 were that were looked at. I think that would

14 solve a lot of this and shorten the document,

15 which becomes, I think, very difficult to

16 follow.

17 Mike?

18 DR. FOSTER: I just don't want to

19 belabor the point, but the people that are

20 doing the chamber studies fully read this

21 document and can understand this document. 

22 Okay? So, there is not a great deal of
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1 emphasis that has been placed on the exposure

2 or concentration during the exposures. That

3 is another question that has come up, whether

4 you should use a gradually5 increasing/decreasing, like a triangular, or

6 a wave form, a straight wave form. So, there

7 are questions that have some relevance to what

8 is going on ambiently.

9 In addition to that, many of the

10 studies have, if you don't do exercise, Fred,

11 you have to go up above 500 ppb to get a

12 response. Okay? So, then, the idea is to

13 assimilate someone in the ambient conditions

14 with light activity or, then, to err on the

15 side of safety, they really ramp up, and some

16 of the California studies that Ed Slagle has

17 done and the Adams lab.

18 But the other point that comes

19 into play that maybe John will comment on is

20 that many of the studies will scale that mV

21 level to a body surface area. But there's

22 ethnicity differences on body surface area,
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1 and you would be better off scaling to just

2 height or just the lung volumes because you

3 are going to overdose, say, for example,

4 African-Americans compared to a Caucasian

5 because of body surface area.

6 They are all things that are being

7 tweaked out now. So, I think that the

8 document and Figure 6.1 and 6.2, they are

9 making an effort to translate the information

10 that, one, there is some threshold slightly

11 above whatever it is, ozone above, slightly

12 above whatever ambient is.

13 And, then, two is the fact of this

14 dichotomy of response, which I wish Steve

15 would jump in because maybe it is going to

16 come in later, and it is in later chapters,

17 but there's definitely host factors that come

18 into play.

19 So, that's all.

20 DR. KLEEBERGER: Actually, could I

21 just make a quick point?

22 I didn't read this chapter real
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1 carefully, but --

2 DR. FOSTER: I can't blame you.

3 (Laughter.)

4 DR. KLEEBERGER: But I did notice

5 that there is appropriate sort of emphasis on

6 interindividual variation in responses. But

7 most of these, as you point out, are FEV1

8 sorts of measurements or metric measures,

9 because they are reproducible, they are easy. 

10 And I seem to recall that there

11 were other studies that had looked at lavaged

12 PMNs and also found that there are individual

13 variations and responses --

14 DR. FOSTER: John Balmes did --

15 DR. KLEEBERGER: Balmes did it. 

16 Slagle did it. I think Al Koren had done some

17 studies.

18 DR. FOSTER: The problem is they

19 are terrifically underpowered.

20 DR. KLEEBERGER: Well, they are,

21 but, still, if you look at the points, and if

22 you plot them -- you can sometimes take these
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1 data out of the tables and plot them yourself

2 -- I mean there is a very wide dichotomy

3 between those responders and non-responders.

4 And at least some mention ought to

5 be made that it is not just FEV1, but there

6 are also other factors that are important.

7 DR. SAMET: Fred?

8 DR. MILLER: First of all, you're

9 right, but, also, the Kim study is not

10 underpowered and they did show effects on the

11 PMNs. They had an "N" of 59, more than

12 adequate for the statistical power.

13 But, Mike, I hear what you are

14 saying, but this document is supposed to be

15 able to be read by individuals that aren't

16 total experts in their own field. And that is

17 what I think ends up being missing by not

18 being able to tell the whole story.

19 You know the literature. You can

20 fill in, and you automatically fill it in. 

21 But that is not the case for everyone who

22 would read this, and there is a certain level,
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1 I think, of expectation as to a reasonable

2 intellect, that you can then follow

3 everything. And right now, I think the

4 commenters are saying some of that is just

5 missing.

6 DR. SAMET: Let's see, who else

7 would like to comment here? Yes? Ed? And,

8 then, George.

9 MR. AVOL: Okay, not on this

10 point?

11 DR. SAMET: Not on this point. 

12 Any other point.

13 (Laughter.)

14 MR. AVOL: It is a new point.

15 DR. SAMET: What?

16 MR. AVOL: It is a new point.

17 DR. SAMET: A new point.

18 MR. AVOL: A new point. So, I

19 have a comment on a section here that sort of

20 re-stirs a decades-old discussion, sort of

21 like the Hatfields and McCoys.

22 And I am not sure whether I am a
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1 Hatfield or a McCoy, but I know I don't like

2 the word "adaptation". This issue of

3 discussing repeated exposures and the blunting

4 of the response, the development of

5 toleration, describe it any way you will, but

6 I don't believe it is adaptation.

7 And when this was first reported

8 in chamber work, now 25-30 years ago, there

9 was a discussion about this. I think while it

10 may not have been agreed upon, there was

11 certainly strong discussion about it not being

12 adaptation.

13 DR. SAMET: So, what would you

14 suggest, that there should be a more broader

15 discussion of the phenomenon and its potential

16 implications, and adaptation is too strong a

17 term, I think, from your point of view?

18 MR. AVOL: Yes.

19 DR. MILLER: Yes, and it is also

20 used interchangeably. To me, the functional

21 changes and their decline in decrement, it is

22 attenuation. Attenuation, adaptation, and
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1 tolerance, they are all kind of used

2 interchangeably at different times by

3 different people. And so, it ends up being

4 very sloppy and misleading.

5 DR. SAMET: Point taken.

6 Howard

7 DR. NEUFELD: I was just going to

8 say, in the ecological literature, I mean we

9 reserve adaptation for an evolutionary change.

10 (Laughter.)

11 And for a physiological change, we

12 use adjustment.

13 MR. AVOL: This is a side issue,

14 but this is a temporary physiological change. 

15 Because if you come back to these same people

16 next spring, and you get a similar response,

17 they start from zero again.

18 DR. SAMET: And certainly,

19 whatever you do, it should be done the same

20 throughout the document, which I think was the

21 point.

22 George?
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1 MR. ALLEN: I guess it is a

2 question for EPA. On page 6-8, where it

3 summarizes the 60 ppb chamber studies, it says

4 on line six, so it is line six, page 6-8,

5 "Although not found to be statistically6 significant in the original studies, they

7 group mean changes in FEV1 at 60 ppb are

8 consistent." But the Kim study, 2011, did

9 find FEV1 to be significant.

10 So, does that need correction or

11 am I confused?

12 In fact, just reading from it,

13 FEV1 change was 1.71 plus or minus .5 percent,

14 mean plus or minus SEM.

15 So, does that need to be --

16 DR. BROWN: It needs to be

17 corrected after adding the Kim study to it. 

18 This was written before the Kim study came

19 out.

20 MR. ALLEN: Well, no, the

21 reference is the Kim study.

22 DR. BROWN: No, but Kim was added
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1 to the prior --

2 MR. ALLEN: And the text wasn't

3 corrected?

4 DR. BROWN: Yes. So, some of the

5 text is still --

6 MR. ALLEN: Oh, okay. Okay. It

7 needs another rev.?

8 DR. BROWN: Yes.

9 MR. ALLEN: Okay. Thanks.

10 DR. SAMET: Let me check. Chris,

11 Kathy, Sverre, if you are there, any

12 questions, comments?

13 DR. WEATHERS: It's me.

14 DR. SAMET: Anything? No?

15 (No response.)

16 Let's see, any other comments on

17 the short-term chapter?

18 (No response.)

19 It's interesting, we spent half

20 the time on this one as on the dosimetry. 

21 Maybe that's it.

22 DR. MILLER: I didn't read this
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1 chapter carefully.

2 (Laughter.)

3 I don't think I read it at all.

4 (Laughter.)

5 DR. SAMET: George?

6 MR. ALLEN: Actually, Jim and I

7 talked about this over lunch. And my take,

8 and he seemed to like it, was that all these

9 chamber studies, whatever effect estimate you

10 come up with, are probably low-end bounds for

11 the real-world effects because, first of all,

12 they are using fairly healthy subjects.

13 Second of all, you are using just

14 ozone as opposed to the overall photo-oxidant

15 mix that is out there with ozone as an

16 indicator. So, your actual exposure metric is

17 different, and a few other things. And they

18 all kind of push these to be a lower bound of

19 effect estimates, and that, I think, is worth

20 keeping in mind when you integrate the chamber

21 work with the epi.

22 DR. SAMET: Okay. Yes?
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1 DR. FOSTER: So, chamber studies

2 have involved chronic obstructive pulmonary

3 disease patients, asthma patients, the

4 elderly, children, and normals.

5 So, you know, the dichotomy is

6 covered. It is just a matter that a lot of

7 them are underpowered, but certainly the

8 trends are there to be able to guide in terms

9 of how this correlates to ambient exposures in

10 the kid studies and the camp studies, and so

11 forth.

12 DR. SAMET: Okay. Let's take the

13 break and come back at 3:20, and, then, we

14 will go to the long-term.

15 (Whereupon, the foregoing matter

16 went off the record at 3:09 p.m. and resumed 

17 at 3:25 p.m.)

18 DR. SAMET: Okay. So, we are

19 going to move on to the health effects of

20 long-term exposure. And let's see, Michelle,

21 you are leading off.

22 And, actually, Mike, I don't think
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1 we designated you. You thought you were going

2 to get away. Yes, well, you've got this one. 

3 So, you can take on the synthesis.

4 Michelle?

5 DR. BELL: Okay. For this

6 chapter, I will just start by saying, overall,

7 not even overall, I agree with EPA's

8 assessments on the degree of the evidence in

9 terms of causality --

10 DR. SAMET: Can you get closer to

11 the microphone? We can't hear you.

12 DR. BELL: Is that better?

13 DR. SAMET: Yes.

14 DR. BELL: Thank you.

15 So, I was saying that I agree with

16 EPA's assessment on the degree of evidence for

17 causality for the different causes. I do have

18 a lot of comments, and I am just going to go

19 over the big-picture comments here, and the

20 more detailed ones you will see in my notes.

21 I do think there is a lot of

22 things that can be done to this chapter to
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1 improve it in terms of presentation and to

2 help people read it and interpret it

3 correctly. But I don't think these are things

4 that would change the conclusion for the

5 causality. So, I think EPA did a very good

6 job for that.

7 One thing I think that could help

8 the interpretation of causality for this

9 chapter, or actually for the whole document,

10 is to talk about what type of evidence would

11 be needed for you to have a more conclusive

12 picture for causality. And I am not talking

13 about writing out what research needs are.

14 But, for example, reading through

15 this, for the topics I am very familiar with,

16 I can know in my head like, well, you know,

17 for more causality evidence, we really would

18 like to see a different study design or a

19 study with more sample size or something else

20 of that nature. But if I didn't already know

21 that, I wouldn't know from this document.

22 So, if there is a way to
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1 incorporate that, just so people know exactly

2 where your causality evidence is coming from

3 for why you choose suggestive versus likely,

4 and so on, I think that could be stated

5 explicitly without making it the research

6 needs documents. And I agree with Jon's

7 earlier comment that this document is not the

8 best place to put that.

9 I actually think that the

10 causality in the long-term exposure chapter

11 could borrow more heavily on the short-term

12 exposure. I think you almost sold yourself

13 short on that.

14 So, just to give an example, for

15 the short-term health effects for respiratory

16 endpoints, you have a lot of information in

17 the previous chapter, looking at a wide range

18 of respiratory endpoints. And even though now

19 we are talking about a different timeframe of

20 exposure, I think it is very compelling

21 towards some evidence of causality, that you

22 have effects for short-term respiratory
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1 outcomes, for example, and then you have

2 effects for long-term respiratory outcomes. 

3 So, I know that in itself would not be

4 causality, but I think that is a piece of

5 evidence that is left out of this document

6 that could be included in terms of looking at

7 the long-term exposure, borrowing from where

8 you found similar health endpoints for short9 term exposure.

10 I think the biggest problem in

11 this chapter that can be fixed is, what

12 exactly do we mean by long-term exposure? And

13 so, this is partly just a language issue. So,

14 there were times where, if I didn't already

15 know the study, I would have no idea what the

16 exposure metric was. Like, was it a few

17 months? Was it a few years? Was it two

18 weeks? And I think it would actually be

19 useful maybe even to lay out at the beginning

20 of the chapter what do you mean by long-term

21 exposure.

22 I think that, whenever a study is
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1 mentioned, in all of the tables that it should

2 say what the exposure timeframe is. Like is

3 three months, this was a trimester, and so on. 

4 And some of the tables do that very nicely,

5 and some of the tables and figures don't list

6 the exposure timeframe at all. So, I think it

7 needs to be listed.

8 This chapter has a huge range of

9 what is meant by long-term exposure. It is

10 probably too big a range because there are

11 actually studies in the long-term exposure

12 chapter that range from exposure metrics of

13 like a 10-year average to a single-day

14 exposure. And I don't know what framework a

15 single-day exposure counts as long-term

16 exposure. So, that is a huge problem.

17 And what I suspect happened is

18 that a decision was made to keep the birth

19 outcomes work together. Is that what

20 happened? I see some nods.

21 I could kind of figure that out,

22 that that was what was happening. For me, it
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1 didn't work because you have like the same

2 health endpoint. Like take respiratory

3 mortality, and you will put the short-term

4 studies in the short-term chapter and the

5 long-term studies in the long-term chapter. 

6 So, there you have chosen to cluster the

7 studies based on the timeframe of the exposure

8 metric, but for birth outcomes you have chosen

9 to cluster it based on the health endpoint.

10 So, I think you have options of

11 either making birth outcomes its own section,

12 if you think it is really critical to keep

13 those together, or splitting them out to be

14 consistent with what you have done previously. 

15 I mean, really, I think it was extra-confusing

16 given that there is so much lack of

17 specification of what you mean by long-term

18 exposure.

19 The evidence is probably weakest

20 for long-term exposure to ozone in mortality,

21 although I do agree with EPA's conclusion that

22 there is suggestive evidence. But given that
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1 this evidence is not quite as strong as some

2 of the others, and you are really relying

3 incredibly heavily on one single study, on the

4 Jarrett study, so I would have liked to have

5 seen more information on those studies, on

6 what they did, what was good about them, and

7 what some of the limitations were.

8 So, for example, you have a long9 term exposure study where we only know where

10 the person was in enrollment. You don't

11 actually know where they were throughout these

12 many years. So, it is a little potentially

13 misleading to say we had ozone followup for

14 several years of these people. You really

15 didn't. They are just assuming a low level of

16 residential mobility.

17 And the authors do explicitly

18 state this in their Journal article. So, you

19 could even borrow that example and make sure

20 it comes in here. But I think, in general, I

21 would like to see more information on that,

22 just because it is so heavily based on one
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1 study, even though I do agree with the overall

2 conclusion.

3 And just one last point, there are

4 a lot of examples in here, and I will have

5 some specifics in my written notes and I can

6 add some more, but a lot of examples of

7 wording that is going to be quite misleading

8 to people. My read of this is that it was not

9 a misunderstanding of the study, but it was

10 just poor wording choices by the EPA staff

11 that wrote it. So, I will just give two

12 examples that I think make this point.

13 One is when you talk about the

14 seasonal studies. And here, the seasonal

15 studies in this chapter are referring to

16 exposure over a few months. So like, what is

17 my exposure over the summer and how does that

18 affect my health risk? Whereas, when I see

19 seasonal study, I immediately think of the

20 short-term studies that like only looked at

21 what is your present-day ozone exposures

22 association with mortality risk just in the
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1 summer, for example.

2 So, language like seasonal studies

3 is going to be a problem. And you can fix

4 this by going through the whole document and

5 putting in those specific exposure metrics

6 everywhere.

7 And there is just one more example

8 that I will bring up that, again, I think is

9 a not a misunderstanding of the study, but,

10 rather, it is just a poor wording choice. So,

11 I will just read this sentence.

12 "A 10-ppb increment and exposure

13 to ozone elevated the risk of death from

14 respiratory causes," and so on. That

15 sentence, it's not wrong, but it is not what

16 happened. There is nothing magical about 10

17 ppb. And this type of language, in fact, a

18 version of this sentence shows up over and

19 over. So, there is nothing magical about 10

20 ppb. That is just the increment the authors

21 used to express their results.

22 What they found is that higher
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1 levels of ozone are associated with higher

2 risk. So, you can keep 10 ppb and put in the

3 central estimate, so that it makes sense, or

4 you can take out 10 ppb, but, I mean, it could

5 have been 9, it could have been 5, it could

6 have been 17.

7 And so, that is the type of

8 language that I think, if you already

9 understand the literature, you know what is

10 meant. But if you don't, it is going to be

11 incredibly confusing.

12 So, I would suggest to take a step

13 back from this chapter, and in terms of the

14 wording, just to go through it and make sure

15 all of it is going to be clear and accurate,

16 because there is really no reason we can't fix

17 those types of things in this document.

18 Those are my main big-picture

19 comments.

20 DR. SAMET: Okay. Thanks.

21 John?

22 DR. BAILAR: I think, overall,
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1 this is quite a strong start. And I don't

2 have much to add to the draft and to what

3 Michelle has already said.

4 I would like to underline the fact

5 that short-term data and long-term data can

6 really reinforce each other. And I would be

7 glad to have a very short section, maybe just

8 a couple of paragraphs, that bring them

9 together.

10 I understand the reasons, and

11 agree with the reasons, for keeping them

12 separate in the initial analysis, but I think

13 at some point they should be integrated in a

14 way I have seen here.

15 Just a few other things. I would

16 like to see a short discussion of why current

17 findings differ from those in the previous

18 review. Are the prior results fully

19 consistent with current results, given the

20 differences in study methods, precision, and

21 so forth? Again, I think that could be dealt

22 with very briefly.
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1 Asthma is a lethal disease. Death

2 from asthma is sufficiently uncommon that it

3 might not show up in studies of total

4 respiratory mortality. If the relative risk

5 is high, a relation to ozone might be evident

6 in a mortality analysis focused on asthma, and

7 I don't know whether this has been done. If

8 not, that might be worth a comment.

9 I understand the effect on

10 mortality of adding PM to the ozone model, but

11 what about the reverse? I would like to see

12 side by side the effects of PM alone, of ozone

13 alone, and their separate effects when both

14 are in the model. That is the only way that

15 I could understand whether the apparent effect

16 of either one is in part or totally a result

17 of their co-occurrence.

18 Overall, I concur with the ISA

19 that there is likely to be a causal

20 relationship between long-term exposure to

21 ozone and respiratory morbidity. I might even

22 make a statement a bit stronger. The evidence
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1 is really pretty persuasive, though not as

2 strong as for short-term effects. This

3 conclusion, my conclusion here, is based

4 primarily on the epidemiologic evidence, but

5 seems to be fully supported by toxicological

6 and human experimental findings.

7 That's all.

8 DR. SAMET: Okay. Thank you.

9 Judy?

10 DR. GRAHAM: With the caveat

11 offered before, I really just scanned the epi

12 studies. So, having said that, a fair amount

13 of this work here is supported by the animal

14 studies. And so, based upon that, I support

15 the causality conclusions. The problem is I

16 support the causality conclusions based upon

17 what I know, not what I read.

18 I would say that, more so than the

19 acute chapter, there are distractions in here

20 and missing references. For example, on page

21 7-14, the evidence from toxicological studies,

22 the first paragraph, for all practical
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1 purposes, dismisses animal studies, in

2 particular, basically, the rats, who cares? 

3 Really it is, I mean I will use the word

4 egregious in terms of how these animal studies

5 are totally dismissed. And even the Plopper

6 studies in monkeys are just all truncated. 

7 So, here's like six or seven lines of

8 references to the Plopper studies, and some of

9 them that are teased out without quite knowing

10 what -- you can't get shape to it.

11 One of the important things, and I

12 think Michelle or maybe you, John, talked

13 about getting a sense of the acute and chronic

14 timeline. There are actually some excellent

15 figures in the last document that show like

16 the time course of events, how the

17 inflammation comes and wanes and then

18 interstitial changes increase. You get more

19 fibroblasts. You get fibrotic-like changes.

20 When I was done reading this, I

21 did my little search thing. And the only

22 place in this whole chapter that I found the
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1 word fibrosis, and I looked for F-I-B-R-O in

2 case it was fibroblast or something, fibrotic

3 changes were mentioned only in the summary,

4 one line where it was cross-referencing the

5 2006 document.

6 Now these interstitial changes,

7 fibrotic-like changes, I think that a

8 pathologist would probably call them mild, but

9 it is not even mentioned. I mean these are

10 significant effects that have implications to

11 severity of effects, and they are just not

12 brought out.

13 I think, in particular, like

14 there's three major studies of seasonal

15 effects, but only once referenced. There are

16 several studies on age, but only a couple of

17 them are mentioned. And in my writeup here I

18 mentioned some specifically.

19 For example, .12 ppm in rats for

20 six weeks; .12 ppm, that is not that high,

21 give the dosimetric comparisons. And guess

22 what? You can actually do dosimetric
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1 comparisons from this study. It wasn't done.

2 They compared morphometry of one3 day-old rats and six-week-old rats at the

4 beginning of the study. There were some age

5 effects. You wouldn't know it from reading

6 here.

7 The effects on children, we call

8 children a major susceptibility group that we

9 are concerned about, but here are these age

10 studies that aren't even here.

11 Chang, et al., they had a couple

12 of chronic studies. They had a baseline of

13 .06 ppm on which was superimposed a spike to

14 .25 ppm. At the time it was done to model an

15 urban pattern, and they were looking for

16 chronic effects. And the lungs were examined. 

17 It was James Crapo's lab that did it. So,

18 they had all this very sophisticated

19 morphometry even after exposure ceased. And

20 guess what? Some of the changes were

21 irreversible.

22 So, there's some of these
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1 important sorts of concepts that have a great

2 bearing on severity of effects and

3 understanding some of the things that may be

4 happening in the epidemiology, some

5 feasibility sorts of things. The papers

6 aren't even here.

7 I won't repeat in any detail what

8 I have said, but show me the tables. I mean

9 there is just so much overwealth of stuff that

10 could be handled in the tables, and you can

11 pick one or two studies for like a full

12 paragraph and say, hey, there's five of these

13 studies; go look at the table.

14 The separation between the old and

15 the new literature is the same problems that

16 I have in the other chapters I have in this

17 chapter, too. I won't repeat that.

18 The only additional thing I might

19 have to mention here is the whole section on

20 repro developmental effects. I have some

21 detailed sorts of comments.

22 But in the big picture, and you
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1 don't need to answer this here, I hope that

2 either you have had or will have an

3 epidemiologist who does reproductive

4 developmental stuff. I mean like some of the

5 NICHD epidemiologists. I am not expert in

6 that area, but some of these writeups just

7 kind of worried me. So, that is my only

8 comment.

9 DR. SAMET: Okay. Thank you.

10 Others? Fred?

11 DR. MILLER: I want to follow up

12 on the last sentence on page 7-62 about that,

13 collectively, the evidence is suggestive of a

14 causal relationship between long-term ozone

15 exposure and all-cause mortality. And I will

16 follow it up with what was an earlier comment

17 here.

18 I have a problem with that

19 conclusion when you really have only the

20 Jarrett study, and you look in that table, and

21 any cause, it is statistically not significant

22 because the relative risk, where the ozone 96
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1 MSA contains one, when you add in PM, it is

2 statistically-significantly protective. Give

3 me a break.

4 These data in this chapter,

5 collectively, relative to the mortality, in

6 the birth weights, for example, this study

7 showed 1.4 ounces change. This study did not

8 show that. And, then, for them to come down

9 to this kind of a statement of causality with

10 mortality is, to me, it is before primetime. 

11 It is not ready. I don't see it when I look

12 at the statistics.

13 And you are talking here about

14 confidence limit, 1.003 to 1.026. And when

15 they flip, and as Dr. Bailar pointed out, when

16 you add in other pollutants and you get a

17 shifting, you know, that is a question of a

18 concern about, if you could look at other

19 things, would the effect go away? Well, here

20 you had it statistically shift for all causes

21 to be protective. And, then, your conclusion

22 is that it is suggestive of a causal
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1 relationship between long-term ozone exposure

2 and all-cause mortality. It is a non sequitur

3 in logic.

4 DR. BAILAR: I think this whole

5 relationship of ozone to other pollutants

6 needs more consideration than I have seen in

7 this document, though I have to admit that I

8 haven't read the whole 1,000-plus pages.

9 It is not uncommon to find that A

10 has an effect, B has an effect. When they are

11 in the same model together, neither one of

12 them has a significant effect.

13 What that tells you is that A or B

14 does have an effect, and the data are not

15 sufficiently strong to tell which one. This

16 sort of effect could even account for an

17 apparently protective effect.

18 That is why the whole thing needs

19 more exploration.

20 DR. BELL: Yes, I just want to

21 comment on that sentence, versus all-cause

22 mortality. I mean even the authors of the
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1 study only drew conclusions for respiratory2 related mortality, which is the one that is

3 statistically-significant all the way across

4 the three different columns in Table 7.7.

5 So, I think that I agree that all6 cause mortality is a stretch. I think if that

7 sentence said respiratory mortality combined

8 with the word suggestive versus causal, that

9 I think would be more in line with my

10 interpretation of what the authors are

11 writing. Even in the Journal article, they

12 refer to a relationship of respiratory

13 mortality, not all-cause mortality.

14 DR. SAMET: It is probably a more

15 general issue here, and that is related to the

16 extent of evidence that moves one from

17 inadequate to suggestive in general, as

18 opposed to in particular. And it would appear

19 that here, in particular, might be only one

20 study bolstered with some of the other

21 evidence that we have been discussing.

22 So, I guess a question would be,
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1 and this is you setting precedent, in the

2 minds of the agency, as you apply your rules

3 for weight of evidence, is one study with some

4 of the limitations of the evidence pointed

5 out, particularly around all-case, I think,

6 you know, it is not a whoppingly-strong

7 effect. Of course, we would not expect a

8 whoppingly-strong effect on such a non9 specific outcome. But is this enough your

10 minds?

11 Well, apparently, it is, but it

12 may not be in the minds of everyone else

13 around this table, and probably even within

14 the agency, I suspect. If you were to put

15 this in front of people, you would get a range

16 of opinions.

17 So, I think maybe you should be

18 thinking about that general question as well

19 as the particular one that has been raised.

20 Let's see, other comments? Yes,

21 Helen?

22 DR. SUH: I want to actually
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1 reinforce that notion also with regard to

2 cardiovascular effects. I think for

3 cardiovascular effects the potential for

4 confounding by PM might be particularly of

5 concern.

6 And from the writeups certainly in

7 Chapter 2, but also in Chapter 6 and 7, I

8 don't think it was justified enough in my mind

9 to say that -- the difference between

10 suggestive and inadequate, it was very murky

11 to me. And from the definitions of causality,

12 it still wasn't that clear.

13 And so, whether it was right or

14 wrong, I am not sure. But I think there

15 needed to be some additional either better

16 definition of what suggestive means and what

17 inadequate means and/or, also, better

18 justification for whichever one was decided.

19 DR. SAMET: Okay. Anyone on the

20 phone want to comment?

21 DR. WEATHERS: No additional words

22 from me.
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1 DR. SAMET: Okay. All right. 

2 Anyone else? Again, so we are dealing with

3 Chapter 7. Anything else? Yes?

4 I don't know. Sverre, are you on?

5 (No response.)

6 If he were, I am sure he would

7 have had comments.

8 DR. MILLER: Yes, I can't believe

9 that Sverre's written comments would endorse

10 a lot in this chapter. They would not. I

11 mean there has been an awful lot of hand12 waving here.

13 DR. SAMET: Okay. Well, we will

14 see this again.

15 Let's move, then, to question 9,

16 Chapter 8, susceptible populations. Steve?

17 DR. KLEEBERGER: Okay.

18 DR. SAMET: Oh, actually,

19 Michelle, sorry, could you summarize, please,

20 be the summarizer?

21 DR. BELL: You want me to be the

22 summarizer?
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1 DR. SAMET: For the charge

2 question response. Thanks.

3 DR. KLEEBERGER: So, there are two

4 questions.

5 DR. SAMET: Steve, you might just

6 pull it closer.

7 DR. KLEEBERGER: Are the

8 characteristics included within the broad

9 susceptibility categories appropriate and

10 consistent with the definitions used? I have

11 got a couple of comments about this.

12 Actually, given the amount of

13 discussion we had with the previous two

14 criteria discussions that I have been involved

15 with, NOx and SOx, when we had a lot of

16 concern about what vulnerable means, what

17 susceptible means, the fact that they came

18 upfront and said susceptible, they are going

19 to be lumpers here; everything is included

20 under the sort of heading of susceptible. I

21 thought that was appropriate and made it

22 easier for me to sort of read through this
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1 chapter. So, that was very helpful in moving

2 forward.

3 I think that the authors also did

4 a really good job of capturing what I think

5 are considered to be the most important sort

6 of susceptibility categories. Clearly, the

7 authors are splitters here, and that is fine. 

8 I could have actually been more of a lumper

9 and put some of these together into more broad

10 categories.

11 But, given the question, are all

12 the categories included, I would say yes. The

13 way that they are captured might be changed a

14 little bit. You might think about tweaking

15 that a little.

16 So, again, in general, I think

17 that they got most, if not all, the categories

18 that I would consider to be important, sort of

19 pre-disposing or susceptibility factors for

20 response to ozone.

21 Are there any key susceptibility

22 factors that were not included and need to be
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1 added? So, given my response to the previous

2 question, my answer is probably no. But I

3 think that there are some sections that could

4 have been expanded just a little bit, and

5 these are in my comments, my written comments.

6 And I won't go into all of those,

7 but I will sort of spend some time with the

8 genetics section, which I thought was well9 written. I think it really does sort of

10 consider most of the association studies, the

11 epidemiologic studies, some of the chamber

12 studies that have been done recently that have

13 looked at polymorphisms that associate with

14 adverse outcomes.

15 One of the things I think I

16 probably might recommend that you add is that

17 especially the chamber studies are limited to

18 only those genes that have a very high minor

19 allele frequency. That doesn't mean that

20 there aren't other genes that couldn't be

21 important, but because of the small sort of

22 scale of the exposure studies, you really
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1 can't do some of these other genes that have

2 a smaller minor allele frequency. So, I think

3 I would put that sort of bit of information in

4 the document.

5 I was a little bit surprised that

6 there was limited discussion of tox studies

7 done in animal models. So, my recollection is

8 that there were discussions about NQ01 and one

9 or two other genes, but in terms of

10 susceptibility genes in animal models, there

11 are many, many studies with knockout models,

12 transgenics, knockouts. Positional cloning

13 studies have identified QTLs that associate

14 with differential responsitivity to ozone.

15 I think that we have kind of

16 short-shrifted all the animal studies in terms

17 of the genetic susceptibility. And I would

18 recommend putting in a table of some sort that

19 would list categories of genes that might be

20 involved in, or have been shown to be involved

21 in, these animal studies. I think that would

22 be really helpful. Because, again, we have
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1 the limitations in the human studies, the

2 animal studies can help inform going forward.

3 Inclusion of diet as a

4 susceptibility factor, I think this is the

5 first time it was included in this sort of a

6 document. I think it was a great idea.

7 It was a little bit short. So,

8 vitamin C and E were considered. There are

9 studies with vitamin A that have been done in

10 the past. There has been work on caloric

11 restriction that could and should be included

12 in terms of susceptibility to ozone-induced

13 effects.

14 I have got a number of minor

15 comments that, again, are written. I won't go

16 through all of those.

17 I think obesity could be included

18 in the table of potentially-important factors.

19 It wasn't clear to me why Nrf2 was

20 stated as a possible susceptibility gene. I

21 don't think any studies have been done on Nrf2

22 and ozone. I think I would have known about
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1 those. It just said that it is a possible

2 susceptibility factor, but there is no

3 evidence to suggest that it is.

4 And, then, my last comment, INF1

5 and INF2 should be identified as quantitative

6 trait loci, not genes. They are regions on a

7 chromosome that were associated with

8 susceptibility.

9 But, otherwise, I was actually

10 pretty pleased with this chapter.

11 DR. SAMET: Okay. Fred?

12 DR. MILLER: Well, this will be

13 shorter than the dosimetry.

14 (Laughter.)

15 The first charge question about if

16 the characteristics included are consistent

17 with the definition and that, and the answer

18 certainly is, yes, but I don't like the

19 definition.

20 As a statistician, I am used to

21 seeing tolerance distributions. And you are

22 lumping in tolerance distributions which
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1 should be really the definition for

2 susceptibility because in a dose response

3 situation, at the lower dose you have a broad

4 tolerance distribution due to the sensitivity

5 of various individuals to be able to respond. 

6 And as you dose higher and higher, that

7 narrows. And that tolerance distribution is

8 really what is talking about capturing the

9 innate biological sensitivity.

10 You have written a definition that

11 you capture everything under the sun. And it

12 is a good thing that you did because, without

13 it, I couldn't have really read the chapter

14 and agreed with a lot of your statements. So,

15 while I don't personally like it, you stuck

16 with your definition and you adhered and put

17 the material that basically supports what you

18 have chosen to write as that.

19 On this other major charge

20 question, are there key susceptibility factors

21 that were not included, I tend to say, yes,

22 there was one. It is exercise, and it was
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1 only indirectly treated as part of the

2 sections on children and on the outdoor

3 activities. But, yet, at ambient exposure

4 levels, exercise or the level of minute

5 ventilation is by far the single most

6 important driver for the amount of ozone

7 inhaled and the probability of causing effects

8 in any subject of any age of any disease

9 condition. And it is just not here.

10 To me, the chapter would be

11 stronger if there was more brought in on

12 evidence from animal tox studies at various

13 points.

14 I will point out Section 8.1.1 on

15 influenza infections. It is a short paragraph

16 about the epi studies, but there are a number

17 of animal studies showing disability for

18 increased respiratory infections even to

19 exposures as low as .08 parts per million.

20 So, more cross-correlation in

21 building between the two I think is a

22 situation where the animal studies in some
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1 areas can add strength to what you are

2 describing.

3 I thought the Section 8.2.2 on

4 older adults, you know, you have indicated in

5 the summary that older adults are one of the

6 more susceptible subpopulations. But when I

7 read that section, I got pluses and minuses,

8 and I didn't see a clear pattern that said

9 that older adults are one of the susceptible

10 subgroups. So, I don't know if it was just a

11 matter of the way I focused on particular

12 studies, but that story didn't come through to

13 me.

14 And, then, one thing, when you

15 talk about not having enough power, why on

16 8.4, line 9, would you even discuss an

17 epidemiology result based on an N of four? It

18 is absolutely ludicrous. Nobody in their

19 right mind would put any faith from an epi

20 study on such a sample size. And it is not

21 even worthy of discussion, in my view.

22 The same way about why ozone
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1 studies back in the animal tox at 3 parts per

2 million for three hours that absolutely

3 obliterated the lungs of the animals and

4 caused the ability of ozone to interact

5 directly with the blood, why such studies

6 would even get one line in here? It just

7 shouldn't happen.

8 So, overall, those are the things. 

9 But I think, as a chapter, I enjoyed reading

10 it because I thought you were comprehensive. 

11 I don't know what other kinds of categories,

12 except maybe a little more, like I say, on the

13 exercise, that you could have needed to bring

14 in to say these are possible susceptibility

15 aspects.

16 So, those are my comments.

17 DR. SAMET: So, just a comment. I

18 was refreshing my memory here on the PM

19 document. And I think I already voiced my

20 opinion. I don't like what you have called

21 susceptible because you have really grouped

22 susceptible in a biological sense with more
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1 heavily exposed.

2 And, in fact, I went back and

3 looked at the equivalent chapter in the PM

4 ISA, and some of the same language is there. 

5 I don't think I liked it then. I probably

6 said that. I hope I did.

7 But, then, what you actually say

8 here is entirely inconsistent with the use of

9 the word susceptible in the policy assessment. 

10 It does not line up at all. Where there is

11 extensive discussion of protection of

12 susceptible populations, susceptible

13 individuals, limiting exposure to protect

14 susceptible individuals, okay?

15 And so, I mean, you have actually,

16 I think, muddled the concept as it will be

17 used when you sort of get to the critical

18 point of decisionmaking, at least in my

19 thinking.

20 So, again -- and I think Fred

21 alluded to this -- we are talking about a

22 distribution of likelihood of response, given
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1 exposure, and that there is such a

2 distribution, and some people, for one reason

3 or another, are out at the higher or the lower

4 end. And some people, for one reason or

5 another, will have exposures at the higher or

6 lower end, and those relate to diverse

7 characteristics. I don't see that you do

8 anything but muddle by putting this together.

9 And, then, later, when you have to

10 come to the policy assessment and deal with

11 the issues of exposure of the susceptible

12 population, I don't think susceptible, in

13 thinking about that issue and thinking about

14 the adequate margin of safety has ever been

15 used in the context of the way you are

16 defining susceptible in this chapter.

17 So, I am actually sort of

18 concerned about the path you have set, and I

19 am not sure why you need to stick to it.

20 DR. BRAIN: I have the same

21 recollection and remember a long discussion. 

22 Didn't we finally end up with susceptibility
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1 and then vulnerability?

2 DR. SAMET: And vulnerability. I

3 thought vulnerable was the other --

4 DR. SUH: I think, though, we

5 decided we didn't like that, either.

6 DR. BRAIN: We didn't like that?

7 DR. SAMET: Well, we talked about

8 it. Some of us did.

9 DR. SUH: I think we were muddled

10 ourselves.

11 DR. BRAIN: We certainly liked the

12 distinction between inherent biologic

13 responsiveness --

14 DR. SUH: Right.

15 DR. BRAIN: -- versus increased

16 likelihood of exposure.

17 DR. SUH: Right.

18 DR. SAMET: Yes.

19 DR. SUH: It was a highly

20 exposed --

21 DR. SAMET: If I ever said I liked

22 what was in the PM ISA, I don't like it
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1 anymore.

2 (Laughter.)

3 DR. BRAIN: But we should have a

4 uniform --

5 DR. SAMET: It should be uniform. 

6 But I actually do think there is this

7 disconnect between the way the word will be

8 eventually used that is of concern.

9 DR. VANDENBERG: So, can I just

10 rehash old history? We did go back and forth

11 between PM draft one and CO first draft, and,

12 then, PM draft two and CO draft two. We kind

13 of came to this with a lot of discussion with

14 the other panels, actually.

15 So, this is very consistent with

16 what we ended up with in CO. And part of it

17 was Jason did an analysis and a

18 presentation --

19 DR. SAMET: Right.

20 DR. VANDENBERG: -- about the use 

21 of susceptible versus vulnerable.

22 DR. SAMET: Right.
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1 DR. VANDENBERG: Well, it was this

2 confusion about susceptible and vulnerable. 

3 And there is a lot of different language that

4 has been used in a lot of different settings

5 within EPA, outside of EPA. It is muddled. 

6 Muddled? I guess that's a word. Muddy.

7 And so, this is where we ended up. 

8 We certainly welcome comments, but, again,

9 this is sort of trying to be consistent across

10 the different ISAs.

11 And Helen is shaking her head

12 because I think she was one of the ones that

13 commented at the time.

14 But it certainly is something that

15 has been muddied in the literature as well as

16 in the discussions.

17 DR. SAMET: Well, would it be

18 reasonable to go back to first principles? I

19 think we are talking about two phenomena. 

20 One, increased risk, given exposure, and, two,

21 increased likelihood of higher exposure. I

22 think that is actually the --
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1 DR. VANDENBERG: Higher exposure

2 or higher response?

3 DR. SAMET: What? No, they are

4 both.

5 DR. SUH: I think one of the

6 things we had talked about, but I don't think

7 it made it through, was I think originally we 

8 didn't understand what vulnerable meant and

9 susceptible meant, really with the

10 definitions.

11 But one idea was one was

12 susceptibility in that you have some innate

13 characteristics that make you more at risk. 

14 But, then, the other idea was of highly15 exposed groups, which is not really

16 susceptible.

17 But maybe that is one way of just

18 taking that whole other, you know, things like

19 people who exercise outside or like if you

20 have air conditioning. That would be an

21 exposure-related parameter rather than a risk22 related parameter, I would say. And so, maybe
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1 that is a way to try to separate them a little

2 bit.

3 Or at least in the writeup you

4 could put them separately. You could have

5 them a whole other character, like exposure6 related --

7 DR. VANDENBERG: So, just as a

8 clarification, we have talked about exercise

9 as an important consideration here. How would

10 you consider that?

11 DR. SUH: Well, and I thought

12 about that, too. That is why I didn't say

13 that.

14 I mean I guess you could argue

15 that exercise gives you a higher exposure

16 level, a higher dose. So, I would put that in

17 the more highly-exposed because the same

18 person, for example, could exercise or not

19 exercise and, then, have different risks, you

20 know, based on a different exposure level. 

21 But it is not based on their intrinsic self. 

22 And I think that is really the
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1 idea of susceptibility, is there is something

2 intrinsically about you, your gender or your

3 race or your body shape, or whatever it might

4 be, that makes you more at risk; whereas,

5 those factors really control how much ozone

6 you will be exposed.

7 So, I mean I don't know if it is

8 clearer, but it might help separate a little

9 bit without putting a tagline on the highly10 exposed or the exposed category.

11 DR. KLEEBERGER: I was just going

12 to say, in papers that I have written where I

13 have tried to actually make this distinction,

14 what I have done is essentially what they have

15 done. I said there is a susceptibility, sort

16 of, factor. There are intrinsic factors and

17 there are extrinsic factors.

18 The intrinsic factors are

19 genetics, gender, age, health status, perhaps

20 nutrition. I mean these are all sort of

21 intrinsic factors.

22 The extrinsic factors are
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1 everything else: exercise, pre-exposure. You

2 name it, it sort falls in that category. But

3 I still consider them as being susceptible

4 factors.

5 DR. GRAHAM: Yes, I would say the

6 important thing is to define it, and, then, to

7 use that definition throughout. I personally

8 like this definition because, personally, the

9 language I use is sensitivity to represent the

10 intrinsic factors. Oh, you have got asthma;

11 you are young. And, then, you can be in high12 end exposure. You are an outdoor worker; you

13 are a kid and you are outside playing in the

14 school yard at three o'clock in the afternoon.

15 So, I like this definition.

16 If you stick to this definition,

17 you have to follow through on it. My concern

18 is that you have a separate section on

19 preexisting disease, a separate section on

20 age. You don't have a separate section on

21 exposure and dose, to actually call that out,

22 because it is kind of like the exercise is
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1 one. So, since exercise and dose, I think it

2 should be its own little subsection.

3 The other thing I would say is

4 that, I mean, I think we can all agree that

5 this is one of the most important sections of

6 the document because this is where you

7 highlight what groups of people need to be

8 protected and why. So, I would suggest that,

9 for each of these susceptibility groups, that

10 you be very clear about providing certain

11 types of information, four types of

12 information.

13 One, what is the prevalence of

14 this group in the general population? Now for

15 most cases you have it, like here's the

16 prevalence of asthmatics; here's the

17 prevalence of kids. But I think on some of

18 the genetic polymorphisms that information

19 isn't there. For different exercise levels,

20 so get the prevalence for that group in the

21 general population.

22 The other thing is, what is the
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1 nature and severity of the risk? I didn't see

2 a discussion in here about the impact on COPD

3 patients. It was clear in here that COPD

4 patients and smokers had about the same FEV1

5 changes as a healthy person, but I didn't see

6 the discussion of, well, what then?

7 And I know the issue often

8 discussed is that, even though you might have

9 the same degree of change in FEV1s, if you

10 have COPD, that degree of change may have more

11 impact because you have less pulmonary

12 reserves. So, that story.

13 What is the number of hospital

14 admissions for asthmatic kids? What does a 5,

15 10, 20 percent change in FEV1s in healthy,

16 exercising young people mean to their well17 being? So, to get at this issue, what is the

18 nature and severity of the risk for this

19 population?

20 And, then, a third item, what is

21 the concordance of human clinical epi and

22 animal tox data for this particular group?
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1 And as a fourth, does this group

2 have characteristics that result in greater

3 exposure or dose? And that is where you get

4 like the double-whammy going on.

5 I mean the classic is lead. I

6 always use that as an example here. A young

7 child is actually more sensitive, more

8 intrinsically responsive to lead because of

9 the developing nervous system. And, then,

10 they have the double-whammy that they are

11 eating lead paint.

12 So, for this particular

13 susceptible group, do they have any

14 characteristics that make it even worse

15 because they have a higher exposure or dose?

16 DR. SAMET: So, I want to return

17 to this issue. I am going to do a couple of

18 things first.

19 I am going to remind you of what

20 we said about PM. We did not say stick with

21 one term. We actually had some very

22 thoughtful language there, as you would
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1 expect.

2 (Laughter.)

3 And, second, I am going to read to

4 you the definition straight off page 8-1 and

5 make you listen to it.

6 Here is the definition of

7 susceptible populations: Individual- and

8 population-level characteristics that increase

9 the risk of 03-related health effects in the

10 population, including, but not limited to,

11 genetic background, birth outcomes (e.g.,

12 blah), race, sex, life stage, lifestyle,

13 (e.g., blah), preexisting diseases, SES (e.g.,

14 blah) and, finally, characteristics that may

15 modify exposure to 03, e.g., time spent

16 outdoors.

17 I am just going to propose this is

18 not useful, and that when you come to have to

19 talk about protection of susceptible

20 individuals in the context of what the Act

21 requires, this generality and vagueness here

22 really doesn't suffice. And it is not even
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1 limited in any way. It opens itself up to

2 essentially any definition.

3 And since I am now finding myself,

4 I think, in several of these categories, I

5 will have to stop exercising because I am now

6 at risk.

7 In our comments in the first draft

8 ISA, there is actually, I think, a pretty

9 thoughtful dissection of the issues and a need

10 for clarity is what we really called for. And

11 I don't think you have achieved clarity. If

12 you think this is clarity, you have redefined

13 clarity.

14 Not yet. Not yet.

15 So, I just want to finish the

16 point that you are doing all this for a

17 reason. And I think that the way you are

18 developing it is not going to serve the next

19 user of this document as well as it should.

20 So, you know, I think you can call

21 it what it is, and Helen said one thing. You

22 can talk about factors that increase risk,
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1 given exposure, or you can talk about factors

2 that increase exposure or dose. And that

3 comes from a variety of reasons.

4 So, I don't think you've got it. 

5 And I don't know whether others agree, but I

6 think you just don't have it right now.

7 DR. VANDENBERG: If I might, just

8 to clarify, I think that our feedback we were

9 focusing on was not the comments on the first

10 draft ISA, it was the comments in response to

11 the final.

12 DR. SAMET: Well, I liked the

13 first draft ISA.

14 (Laughter.)

15 We'll pull out the second draft. 

16 I am sure they are equally wonderful.

17 But, Fred? 

18 DR. MILLER: I would like to ask

19 that you discuss with your OAQPS colleagues if

20 your definition puts them into a hole that

21 they can't climb out of. Because, basically,

22 this says that exercise, you can avoid issues 
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1 relative to the ozone standard if you simply

2 don't exercise. And you get no significant

3 changes in FEV1. And I don't think that is

4 the intended story.

5 And so, the question is -- I like

6 Steve's intrinsic/extrinsic, and you would be

7 able to discuss. I like Judy's statements

8 about sensitivity and, then, increased

9 exposure aspects.

10 But the way it is now, to call

11 them all equally important aspects of the

12 definition of sensitivity, to me, clouds the

13 issue. It comes back, again, to my basic

14 understanding from Finney Bioassay 101 about

15 tolerance distributions. And this is doing a

16 disservice to what has been the basic

17 understanding in biomedical research relative

18 to sensitivity -- or susceptibility now at

19 this point.

20 So, OAQPS is very important

21 because you guys have to work together, and

22 you can't put the excuse now that they are in
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1 Durham, because you guys are all in the same

2 building.

3 (Laughter.)

4 I know you don't excuse yourself

5 anyway. Don't get me wrong.

6 DR. SAMET: Ed, are you poised to

7 comment here?

8 MR. AVOL: No. I mean I think you

9 have covered most of it. I mean I think,

10 internally, they were consistent; I just think

11 that they don't have the right definition. 

12 And I think that if you follow the logical

13 extension of what you describe as some

14 susceptibility factors, there are a whole host

15 of other ones that get you into all kinds of

16 trouble, like things that might affect your

17 personal cloud. So, now you get into consumer

18 products and what kind of perfume you wear,

19 because that might change the ozone in your

20 community there, and make you more or less

21 susceptible.

22 And, you know, if you are going to
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1 talk about outdoor activities as opposed to

2 exercise, then you have to start to worry

3 about indoor time because indoor time invokes

4 some sort of different kind of indoor/outdoor

5 ratio. So, now I mean there are whole kinds

6 of other things. So, I just think it gets

7 very problematic.

8 DR. SAMET: Okay. Other thoughts

9 about this?

10 Somebody on the phone?

11 DR. WEATHERS: Yes, someone is on

12 the phone.

13 (Laughter.)

14 DR. SAMET: Oh, good.

15 Do you want to comment?

16 DR. WEATHERS: I think I am alone

17 here.

18 DR. SAMET: Maybe. Do you have

19 any comments?

20 DR. WEATHERS: No. Well, yes. In

21 hearing the discussion, am I correct in

22 assuming that there are not clear definitions
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1 in the literature?

2 DR. SAMET: Well, I think,

3 actually, the table that was put together

4 before shows the terms are used widely and

5 differently. And I think some of that

6 discussion was captured when we were dealing

7 with other pollutants.

8 I mean, again, I think what you do

9 here could be very helpful to everyone, but I

10 don't think you have got it right yet, in case

11 you didn't figure that out.

12 (Laughter.)

13 DR. VANDENBERG: We welcome

14 suggestions.

15 DR. SAMET: Okay. Any others? 

16 Howard?

17 DR. NEUFELD: The socioeconomic

18 status section in this chapter, is there --

19 DR. SAMET: Oh, microphone.

20 DR. NEUFELD: Is there any

21 evidence that people of lower socioeconomic

22 status would actually live in areas with
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1 higher ozone?

2 DR. SAMET: Well, yes and no. I

3 mean, because if they are in the inner cities

4 with high NOx, then there is something

5 different going on. But, yes, potentially,

6 yes.

7 DR. SUH: I think it would be

8 lower. Well, it depends. But if lower

9 socioeconomic groups live near roadways, then

10 that would suggest that there will be less

11 ozone. But I don't know if anybody has really

12 ever looked at that explicitly. But it seems

13 that that would be my guess.

14 DR. SAMET: Yes, Michelle?

15 DR. BELL: We did look at this in

16 terms of the overall -- and other people have,

17 too. It basically depends on where you are. 

18 So, there are specific locations where higher

19 levels of exposure to ozone are in groups with

20 higher socioeconomic status, and there's

21 locations where higher exposure to ozone is in

22 communities with lower socioeconomic status. 
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1 So, there will be some overall trends, but

2 certainly any possibility is true.

3 DR. MILLER: And it is also more

4 reflective of your availability and ability to

5 pay for health-related visits. If you have

6 money, I don't care what the ozone level is,

7 your kid, you are going to get him to the

8 hospital. There is a greater chance that they

9 are going to say, "Well, we had better watch

10 him overnight to be sure." Whereas, the

11 person that doesn't have that kind of health

12 insurance, they just don't go. So, there is

13 a selection bias that SES helps to adjust for.

14 DR. SAMET: Okay. Then, Steve,

15 you're it on this one.

16 DR. KLEEBERGER: Okay.

17 DR. SAMET: Okay?

18 And one other thing we are going

19 to do is -- Holly will do this -- we will

20 compile our prior comments on this issue

21 around the PM, and I guess we have CO, and we

22 will take a look at what we have said.
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1 Okay. Integrative summary. 

2 Helen, I think this is you.

3 DR. SUH: Okay. So, this charge

4 question is about Chapter 2. I think it is a

5 good start. I think it does a good job of

6 taking the results from 2006 or the findings

7 and talking about what is new and different,

8 which I think is important for this chapter.

9 As reflected in many of the

10 comments from earlier today, I think the

11 chapter has a bit of an identity crisis. I

12 think in many ways it is a good summary, but

13 I think, really, given that there is a lot of

14 summaries already in the rest of the document,

15 and there seems to be a lot of repetition and

16 borrowing of phrases, perhaps the way I would

17 think of this chapter as being really

18 effective is if it was really more of an

19 integration of the findings across -- across

20 exposure, mode of action, health impacts.

21 And as an example of it, I would

22 say that, for example, with the exposure
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1 chapters there has been discussions about the

2 relationship between or how well ambient

3 concentrations reflect exposures. And you

4 could argue that it doesn't do very well,

5 especially perhaps at the low ozone

6 concentrations that are relevant maybe to this

7 consideration of the evidence.

8 And so, given that the

9 relationship between ambient concentrations

10 and personal exposures might not be so strong,

11 what does that mean in terms of the epi

12 results, for example? What does that mean in

13 terms of susceptibility of different groups? 

14 What is that?

15 And it would be nice to be able to

16 take all that information and put it together

17 in one chapter, including with the modes of

18 action. And I think that would be a very,

19 very useful addition beyond what is in the

20 rest of the document.

21 And I think that the summaries are

22 spread throughout the different chapters, and
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1 maybe that could be fixed by putting an

2 overall summary at the end of each chapter. 

3 That maybe is a little bit more integrated.

4 But I think this part really would

5 benefit from taking all the information and

6 trying to put it together in a story, like

7 what Judy talks about. What is really needed

8 is a story.

9 So, given the results that we know

10 about exposure, what does that mean in terms

11 of the toxicity of ozone that is observed in

12 the controlled laboratory studies? Are all

13 these pieces consistent to tell the same

14 story?

15 And I think that goes together

16 with issues about exposure, error,

17 confounding. What does this mean in terms of

18 epi evidence? How do the controlled

19 laboratory studies -- there are some studies

20 that look at ozone and PM together. How does

21 that inform our conclusions about potential

22 confounding and epi studies?
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1 So, I think there is a lot of

2 evidence that can come together in one

3 cohesive chapter that I think could make a

4 really compelling story for where you got to,

5 I mean where you are going to get to in the

6 future, like in the REA and the policy

7 assessment.

8 So, I think this is a great

9 opportunity. And I would argue that it would

10 come upfront in Chapter 2 rather than all the

11 way in the back because I think this will be

12 a chapter that people will read and really

13 could tie everything together.

14 So, instead of really separating

15 the sections to mirror the chapters that are

16 in the ISA, I would try more for an integrated

17 assessment, maybe by effects. Maybe there is

18 a respiratory or maybe -- I am not exactly

19 sure how you might want to do it. But I think

20 that this is your opportunity to really put

21 all that together.

22 So, I would get rid of like the
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1 exposure, the mode of -- I would just try to

2 put it together. And I think Section 2.6, I

3 thought that was a good job of starting to

4 integrate at least the dosimetry mode of

5 action and the health effects pieces. And I

6 thought that was actually better than the

7 separate sections together.

8 I really liked the use of

9 diagrams, the tables. I thought that was

10 extremely effective. I think something like

11 that as the model would be a great, a better

12 identity for this chapter, I think. I think

13 it would be less repetition. So, I think

14 there would be less complaints about that. I

15 think it would help to reorganize the thought

16 process.

17 And so, that is sort of my main

18 piece. And I guess one little thing. I mean

19 I was very puzzled about this throughout, and

20 I didn't talk about it. But the PRB whole

21 section creates a lot of talk today. Then,

22 also, there was a discussion, a pretty big
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1 discussion in the document.

2 It is clear very spatially and

3 temporally, right? But, then, I wasn't really

4 clear how it was going to fit in with all the

5 rest of the conversation later on. Like in

6 the REA it is clear it is going to play a

7 part, but from this, it just sort of stood

8 alone to me somehow.

9 And I was wondering if it could be

10 better integrated with the rest. I am not

11 sure how exactly, but I think it has to go in

12 with the whole idea of what happens at this

13 low ambient concentration range.

14 And so, anyway, those are just

15 like my overall comments.

16 DR. SAMET: Okay. Let me see. 

17 Chris, are you on?

18 DR. FREY: I am on the phone, yes.

19 DR. SAMET: Okay. Good. Why

20 don't you go ahead?

21 DR. FREY: Okay. Well, I liked

22 Helen's comments. I thought she did a nice
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1 job of organizing lots of thoughts in her

2 written comments, and I support what she said. 

3 I don't have a lot to add, but I will anyway.

4 (Laughter.)

5 I guess, as a reader, I was kind

6 of frustrated with Chapter 2 because I think

7 maybe we don't have a clear idea of who the

8 audience is. We need to have that in order to

9 revise it.

10 The thing that frustrated me is

11 that I think each section was written for the

12 domain expert of each section. And so, it

13 wasn't integrative in the sense of helping

14 people of different disciplines digest this

15 material. You know, if you are not a health

16 effects expert, you are not going to

17 understand those parts of the summary, and so

18 on. And so, it is a hard thing to do, but I

19 think that needs to be the goal. So, I think

20 most of the sections are probably unreadable

21 to someone who is not a domain expert.

22 I agree with Helen about that it
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1 actually needs to be more integrated. It is

2 kind of like a summary of here's the details

3 of specific things in each chapter, but it

4 doesn't necessarily tie things together well.

5 And another frustrating thing for

6 me is it references figures in other parts of

7 the document. I am feeling like I have to

8 flip through hundreds of pages to read this

9 chapter, which is counterproductive. So, it

10 should be a standalone, self-contained

11 document.

12 And I agree with Helen that having

13 figures and tables and graphics is helpful,

14 and I think there should be more of that. And

15 so, for example, where there is a tendency to

16 go off and summarize several studies, why not

17 try to make a table and, then, use the text to

18 synthesize what the key findings are, rather

19 than present sort of a data dump?

20 So, I think that is probably all I

21 am going to say. You know, I submitted some

22 written comments, but, frankly, my comments
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1 are really kind of more editorial rather than

2 technical since we have covered the technical

3 issues in the chapter reviews. And,

4 obviously, whatever revisions happen in those

5 chapters will need to be reflected in the

6 revised integrative overview.

7 Thanks.

8 DR. SAMET: Okay. Howard?

9 DR. NEUFELD: Well, I want to say

10 I thought it was generally a well-written

11 chapter. I may differ a little bit. I

12 actually was able to read the human physiology

13 and tox studies and figure out what was going

14 on.

15 I think that it is a little long,

16 and there are sections, for example -- and we

17 have already talked about this -- that are

18 verbatim the same in later chapters. I think

19 if we eliminate that, then we can shorten the

20 document up some.

21 But there are certain things that

22 could be improved. But, in general, I thought
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1 in reading this -- you know, I am new to this

2 process here -- that I got a fairly good idea. 

3 I mean this is like the condensation of the

4 entire document here. And if someone will

5 take the time to read the 40 or so, 50, 60

6 pages here, as opposed to the 1,000, you are

7 going to get a pretty good idea of the rest of

8 the document, which I think is the purpose of

9 this chapter.

10 And it may be improved. It may be

11 better integrated perhaps with a little more

12 effort, but, in general, I was actually

13 pleased with it.

14 I wasn't pleased with some things,

15 though. I wasn't a fan of some of the

16 figures. I think they were confusing to me,

17 particularly 2-1. It is just too much stuff. 

18 Or maybe it could be --

19 DR. SUH: Well, I loved that one.

20 DR. NEUFELD: Oh, you liked it? 

21 Okay. Well, okay.

22 (Laughter.)
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1 And, then, the one in my field is

2 a little too simplified, Figure 2-3. It is

3 just overly simplified.

4 Let me go on for a few other

5 things here. When I wrote this, it was more

6 specific for some of the larger chapters. So,

7 I won't go through the technical details.

8 There is one sentence that I

9 thought was important, and here's where

10 English matters. It is in Section 2.5.2, and

11 the authors are talking about single-day

12 exposure underestimate the public health

13 impact. So, the first phrase states that. 

14 And, then, the second phrase starts off with

15 a disclaimer "but," and, then, it states that

16 multi-day effects are limited to the first few

17 days.

18 So, to me, the way that is

19 constructed, it seems as if the latter part of

20 the sentence is not as important as the first

21 part. And I would think they are both equally

22 important. So, you might want to change
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1 "but", take "but" out, and substitute the word

2 "while", which, then, to me, gives equal

3 weight to both the clauses.

4 And let me see. There is some new

5 literature coming in that I reference, but the

6 EPA people can pick that up.

7 Let me get to the last part. 

8 There is one section here, the atmospheric

9 chemistry people can tear into me on this

10 since I am not. But in the section, this

11 actually ought to go probably in Chapter 10,

12 but at least it is summarized here. So, I was

13 just going to bring the subject up.

14 And this is on the idea of UV-B15 induced catalyst of elemental mercury. And,

16 then, it is revolatilized into the atmosphere. 

17 So, Dave Schindler has written on this. So,

18 again, it is not a health effect unless you

19 are looking at it like a secondary or tertiary

20 effect, where you have acid rain, you have

21 UV-B, you have ozone, and, then, you have

22 mercury all mixed together. So, it is
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1 something to consider maybe putting into the

2 document.

3 And the other thing is I think

4 this whole document needs a very, very short

5 Executive Summary. Okay? I think we all

6 maybe agree on that. And the last part of

7 this chapter is almost that, those long tables

8 on the last two pages. I think that right in

9 the beginning of this whole document maybe

10 there ought to be an Executive Summary, and it

11 could come right out of these last two pages

12 here.

13 So, okay, I think those are my

14 main comments.

15 DR. SAMET: Okay. Thank you.

16 John, I think we can assume this

17 chapter is a work-in-progress and that it will

18 become more integrative as you integrate?

19 DR. VANDENBERG: Yes, the whole

20 document is a work-in-progress.

21 (Laughter.)

22 DR. SAMET: Oh, really? Oh, okay.
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1 DR. VANDENBERG: That's right.

2 DR. SAMET: But, I mean, I think

3 this fact that some people see it as a useful

4 summary suggests that it is obviously not

5 integrative enough yet. I think if you could,

6 as you rewrite it, resist the cut-and-paste

7 temptation, it would probably help the

8 development of integration.

9 I think the other comment, which I

10 think probably many would support, and

11 obviously you will decide, is whether the

12 document does need a short, upfront Executive

13 Summary, so that someone can go there.

14 I think in answer to who is the

15 readership of this chapter, presumably, it is

16 everyone and that is a wide range of

17 individuals who are going to look to this

18 chapter in a sense as sort of the

19 justification of the bottom lines that are

20 going to be important for advancing. So, it

21 should be broadly readable and not one that

22 you can't move fluidly from section to
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1 section, depending on what your own personal

2 area is.

3 Yes, Ed?

4 MR. AVOL: So, I have two issues. 

5 One was I thought that, as an integrative

6 overview, in some sections it sort of

7 meandered and never quite got to the point. 

8 And one example is in the policy-relevant

9 background discussion. It sort of talked

10 about it. It talked about what effects. It

11 never came right out and said what it was or

12 whether it was going up or down. So, I think

13 you just sort of need to sharpen the

14 presentation a bit.

15 Then, the second issue is this

16 notion that has been discussed somewhat in

17 terms of what the purpose, who the audience,

18 and the placement of this ultimately in the

19 document. And so, I think in terms of

20 placement, if this is going to serve as an

21 Executive Summary, maybe it ought to be at the

22 front. If it is going to serve as an
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1 integrative overview, maybe it ought to be at

2 the back. I don't know what it serves as in

3 the middle. And so, I think you sort of have

4 to think about what its character is and what

5 you want to do with it.

6 DR. SAMET: Fred?

7 DR. MILLER: Along those lines, if

8 you leave it where it is now, to me, you

9 relabel it and call it "document roadmap". 

10 There is no real integration here. The way I

11 would think of integration is what was the

12 kind of chapters in the previous criteria

13 documents. But I would actually favor,

14 because I am not sure what that really adds,

15 that you make it a true integration and you

16 have it as the last chapter, and, then, the

17 boiling down of that becomes your Executive

18 Summary. So, I don't get any value out of

19 this chapter as it stands now.

20 And so, I think you have to decide

21 what you are really after. Because if it is

22 truly integrative and is a summary, then, why
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1 read the rest? So, who is it really intended

2 for, and what function do you want? And,

3 then, that will dictate what you decide to do

4 with it to me.

5 DR. SAMET: Dave?

6 DR. GRANTZ: Yes, I think that

7 this group is where we should resolve this

8 identity crisis, as somebody called it. 

9 Clearly, this is a combination of several

10 different things.

11 I would argue that it should be an

12 expanded Executive Summary, but not the

13 typical three-page Executive Summary. I like

14 having it upfront.

15 But just a little personal

16 history. When I first started reviewing that

17 chapter, I started inserting references. 

18 There is so much detail there, I kept making

19 the comment this is missing a reference. And,

20 then, I realized there weren't any references

21 at all.

22 I think it should be integrative
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1 and shorter, but should be upfront and should

2 be essentially a good, clean roadmap that can

3 be read quickly by anybody.

4 DR. SAMET: Well, let me comment. 

5 If my memory serves me well, which it may not,

6 the purpose of this chapter was to force a

7 kind of integration across the entire body of

8 evidence that was not happening in the

9 individual chapters that we felt was

10 important. And some of this has been alluded

11 to.

12 Short-term/long-term effects, for

13 example, or short-term/long-term effects and

14 susceptibility brought together. There are

15 many overarching issues that in the structure

16 of the document, as it is written, those kinds

17 of connections aren't made.

18 And I think we thought that those

19 connections should be made here, and that this

20 kind of integration across everything -- and

21 maybe this argues for Fred's point about

22 placement -- was not being done and achieved,
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1 but, yet, it was important.

2 To do that, of course, you are

3 bringing forward some of the most critical

4 points and findings of the chapters that

5 follow, but this, I think, again, as we

6 originally discussed the concept, it was not

7 to be sort of an Executive Summary. That

8 would be a different purpose.

9 It was, I think, put in the

10 Chapter 2 position in the ISA because we

11 thought it was so important that, if it came

12 later, just simply people would not get to it. 

13 Now that is a decision that could be

14 revisited.

15 So, it is not supposed to be a

16 roadmap, although Chapter 1 should provide

17 that roadmap. And maybe the right spot, if we

18 think that this truly sort of integrative

19 across the chapters is what is needed, at that

20 point it brings in the welfare effects and

21 climate change, and so on. I think the

22 chapter would be important. It doesn't have
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1 to be long necessarily.

2 And right now, I think it reads

3 too much like an Executive Summary. So, if

4 you want an Executive Summary, you have got a

5 good start on one. But if you want an

6 integrative chapter, you have got a lot of

7 work to do. And probably maybe we want both. 

8 I would suggest that the document could have

9 both.

10 So, why don't others weigh-in on

11 this? John?

12 DR. VANDENBERG: Just one aspect

13 that you might help me clarify here is that

14 part of the goal -- and you can see that it

15 says "a work-in-progress" -- is both to strive

16 towards integration, and of course integration

17 is the last thing you do when you understand

18 everything else that is happening. So, it is

19 the kind of last thing that we create. But it

20 is also to highlight the difference between

21 what the knowledge is now and what the

22 knowledge was in the last review.
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1 And so, some of the tables that

2 people pointed to that they liked specifically

3 said this was 2006, this is 2011. And some of

4 that is because we have changed our framework. 

5 So, you know, there is a change in the whole

6 way we are doing things.

7 But we are also trying, through

8 some of those figures, as Jim presented,

9 highlighted in circles and red some of the

10 newer knowledge areas that had come to light

11 since the last review, because that is an

12 important consideration as we move towards the

13 latter steps of the policy assessment

14 especially, is: what's new for the

15 Administrator to consider in the standard16 setting process compared to what was known,

17 say, five years hence?

18 So, it is an attempt to try to

19 integrate it. It is an attempt to try to

20 highlight the newer knowledge areas and not to

21 just rehash everything that follows.

22 And again, as we have stated, the
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1 reason it was put upfront is people didn't

2 want to read through 1,000 pages before they

3 got to it. But it also tends to be where we

4 point some of those -- you know, within the

5 agency, outside of the agency, there's a lot

6 of different audiences -- to say, well, if you

7 want to read something that is kind of to the

8 point, read Chapter 1 and 2, 1 for the

9 framework; 2 is how we applied it.

10 DR. SAMET: Could we also agree

11 that a well-done Executive Summary, which is

12 probably needed for a 1,000-page document,

13 could serve much of that purpose, and perhaps

14 have this additional chapter doing what we

15 have been discussing here?

16 DR. VANDENBERG: It could very

17 well be. And when we tried, I think it was on

18 a NOx document, to do like an Executive

19 Summary, it didn't work very well. It was too

20 short. And so, there was a sense of

21 dissatisfaction that it just didn't do it.

22 And so, your recommendations,
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1 suggestions are certainly welcome here on how

2 to get this right.

3 DR. SUH: I would really argue, I

4 like it -- if it is an integrative summary, I

5 think it belongs in Chapter 2. I would say

6 that it is how you frame it. So, you could

7 say, well, what follows is really the

8 justification for what comes in Chapter 2 with

9 your integration.

10 But I think if you put at the very

11 end, I think this is the meat. I really do

12 think that in some ways this is really the

13 heart of the document.

14 Chapter 1 explains what happens. 

15 Chapter 2 is sort of the overall. And it is

16 a little odd in the placement, but I think

17 because it is the heart of it, that you go

18 early, and, then, what follows is really the

19 justification and the evidence for what is in

20 Chapter 2.

21 And I think that Chapter 2 really

22 in some ways could be very, very long. So, it
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1 is not really an Executive Summary. It is

2 really a long, I don't know, I guess it just

3 integration.

4 But I guess I think of it, this is

5 really the thing that people are going to take

6 home with them. It is going to say what is

7 different. So, if there is a standard change

8 or there is different causality terms, it is

9 going to lay it out right here. I think that

10 is what you want. And I think it should go

11 early.

12 DR. SAMET: There are lots of ways

13 to --

14 DR. WEATHERS: This is Kathy.

15 DR. SAMET: Yes, Kathy? Go ahead.

16 DR. WEATHERS: Oh, yes, I agree

17 with what I think you said, Jon, which is,

18 whatever step it is, that there be an

19 integrative chapter, whether it is integrative

20 of what is new since the last review or not,

21 I am not sure of, but that there also be an

22 Executive Summary. And maybe that will follow
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1 in this evolving document. So, maybe that is

2 not the goal for the next round, but an

3 integrative chapter upfront should be.

4 DR. SAMET: I mean another way to

5 do this, I am reminded of BR6, biological

6 effects of ionizing radiation, Report No. 6,

7 which, hopefully, none of you have read.

8 (Laughter.)

9 The main point was that we really

10 only had one chapter that was the presentation

11 of the risk model and the risk assessment. 

12 Everything else was an appendix.

13 So, for example, for the point of

14 view of having a linear no-threshold model,

15 what was critical was our understanding of

16 mechanisms and biological facts of alpha

17 particles.

18 I mean, in a way, what you are

19 saying is that Chapter 2 is likely to contain

20 what is going to be most important, the

21 advances in knowledge, how those advances fit

22 together, how our understanding has evolved.
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1 The substrate for that is all

2 these separate chapters. So, another way, if

3 you are worried about the structure, would be

4 to say, well, we have two chapters or an

5 Executive Summary and an introduction, and a

6 50-page integrative summary, and, then, a

7 series of supporting appendices or something

8 that are literature reviews and compilations

9 of evidence.

10 So, I mean I am thinking of

11 different ways to cast this. And perhaps what

12 is best at this point is to -- I don't think

13 we are going to resolve this around the table. 

14 There are a number of ways that you might do

15 this. I think you are going to have to think

16 about what would work best, and probably what

17 will work best for your colleagues who are

18 going to be moving from this onto the policy

19 issues.

20 Yes, John?

21 DR. BAILAR: Different readers

22 will have different kinds of tolerance for
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1 length. I think there is a very strong

2 argument to be made for having a two-page

3 summary because that is all that some of the

4 most important readers are going to get

5 through.

6 I think, also, there is a place

7 for something like a 20-page Executive

8 Summary, if it is written with particular care

9 for understandability by people who are not

10 expert in any of this.

11 I think there is a place for

12 something like the present Chapter 2. And

13 there is a place for the summaries at the ends

14 of each chapter.

15 Each of these things serves a

16 different function for a different set of

17 readers. And I would keep them all.

18 DR. SAMET: Yes, I will just make

19 a comment back to BR6 for a moment. We

20 actually had a two-page public summary, the

21 idea being that anyone could pick it up and

22 read it. And as a Committee, we actually
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1 spent probably more time per word in writing

2 that than anything else in the document. I

3 mean we really sort of battled over every word

4 for probably a day in putting that together.

5 Jack?

6 DR. HARKEMA: And so, if you go

7 that route with this, and I think that is

8 probably good, I just want to emphasize that,

9 even though Helen liked Figure 2-1, the

10 figures are probably going to be what stick in

11 the people's minds the most. And I would be

12 very careful about that figure that you have,

13 especially that one, that Tower of Babel that

14 you have of effects here. I think that is

15 dangerous.

16 So, if you do that, you know, a

17 lot of those reports, like IARC, and whatever,

18 people remember the figures.

19 DR. SAMET: Judy?

20 DR. GRAHAM: Two comments about

21 length. One is a short story. Three or four

22 ozone standards ago, we sweated bullets and
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1 produced a criteria document, maybe 20-30

2 pounds at the time. We sweated bullets.

3 And, then, the Administrator goes

4 to promulgate the standard. I saw it on TV. 

5 She stood up and she said, "We are doing this

6 because it hurts your lungs."

7 I wanted to cry. I thought we did

8 all this work. "It hurts your lungs." We

9 could have gone right to the chase.

10 (Laughter.)

11 I was trying to think about what

12 John said about the new versus the old, and

13 trying to marry that with my profound

14 frustration with the separation of the new and

15 the old.

16 This is something for you guys to

17 think about. Perhaps in a policy sense what

18 is important about new versus old is, did

19 anything change? Are there any game-changers? 

20 It is not a function of, gee, my favorite

21 marine toad is new; therefore, it gets more

22 space. That is not it. The marine toad is
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1 not a game-changer.

2 Perhaps the Kim study is not

3 necessarily a game-changer, but it really

4 pounds in what may be happening at 60 ppb. 

5 So, to look for the game-changers, I mean if

6 you are switching from a possible causative to

7 a definitively causative, the game-changers

8 may only be a page or two pages and, then, the

9 rest of it could be here's the story; here's

10 what has happened.

11 So, even though there is no game12 changer on lung pathology changes, it doesn't

13 mean that it is still not important.

14 DR. SAMET: So, I think, let's

15 see, Helen, you are the writer of this. You

16 know, what I would suggest for now is that you

17 say that we had a wide-ranging discussion of

18 options, and that you list some of the

19 options.

20 (Laughter.)

21 You know, that we have discussed

22 sort of stay where we are. We have discussed
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1 putting this integrative chapter at the end. 

2 We have discussed sort of the two-chapter

3 model. I think there is probably some

4 agreement that some summary is needed, and I

5 think ranging, as John proposes, from very

6 brief to a little bit longer. And I think

7 what we should do is lay that out.

8 I mean, clearly, there is a lot of

9 ways, and I think you are going to have to

10 think about what works and what best gets the

11 messages on to the users of the document. So,

12 you probably need to have some dialogue with

13 them, I suspect.

14 So, I think, unless somebody has

15 another possibility here -- Fred?

16 DR. MILLER: I have one. I

17 actually want to add a chapter. This new, you

18 know, in what's changing, could be in here as

19 a subsection at the beginning. I really favor

20 your integrative summary being the last thing.

21 I get really tired of reading 15-

22 20 pages of the Executive Summary and, then,
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1 15 pages later I am reading the same stuff

2 over, just in a different way. But if you

3 actually included upfront some highlights of

4 the things that are really new, and then go

5 back and taking what you now have as Chapter

6 2 and placing it at the end, and really making

7 it integrated, I think you really have a story

8 to tell for different audiences that they each

9 can get something out of.

10 And I wouldn't call this short

11 thing about what is really new a separate

12 chapter, but it could be part of Chapter 1,

13 you know, of here's where we stand. But I

14 like that from the viewpoint of telling the

15 spectrum from the two-page summary to the

16 short Executive, to, hey, really what are the

17 hot things that are added, but, then, at the

18 very end here's how it is all integrated. So,

19 it is another -- what? -- option 7? I don't

20 know how many we have discussed.

21 DR. SAMET: Let me ask, I think it

22 was Helen in her comments that, in discussing
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1 Chapter 1, said you have to put so much

2 legislative history in it. Was that you?

3 DR. SUH: That was definitely not

4 me.

5 (Laughter.)

6 DR. SAMET: That was not you? 

7 Well, it was Michelle, maybe it was Michelle. 

8 Somebody made that comment.

9 And I wonder again, in sort of

10 cutting to the chase, I mean, do you have to

11 put all this in? I mean, is it sort of

12 requisite or --

13 DR. VANDENBERG: No, I think the

14 requirement, of course, was that we develop

15 air quality criteria to support the decision.

16 DR. SAMET: Right.

17 DR. VANDENBERG: And what exactly

18 that is, we have interpreted it as a

19 reflection of the state of the science. The

20 legislative history is just for the reader to

21 have some history.

22 DR. SAMET: Again, you know,
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1 perhaps this could be an appendix. I mean I

2 am just reading, in 1982, in 1977, you know,

3 et cetera. Again, it just sort of diverts

4 you. It sort of sets a tone for the document

5 to go, "Oh, no."

6 (Laughter.)

7 DR. VANDENBERG: Point taken.

8 DR. SAMET: So, our last item here

9 is the length of the document.

10 And, oh, yes, Helen, you are

11 summarizing.

12 So, Judy, you are the leader on

13 this critical topic.

14 (Laughter.)

15 DR. GRAHAM: I guess my general

16 comment is that any collection of

17 knowledgeable people is going to have a

18 different view of this. So, there is no right

19 answer. There is no number of pages that is

20 perfect.

21 I mean the important thing that we

22 need to focus on is clarity of presentation
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1 for the various audiences who will use it, and

2 particularly for regulatory users. And so, in

3 some cases, you could find places to shorten,

4 but in other cases you might find places to

5 lengthen. I mean to keep your eye on the

6 ball, you know, communicating about the

7 underlying science, about health risk and eco

8 risk.

9 I won't belabor the point, but I

10 think you could go a long distance by putting

11 tables in. That would take care of the

12 problem of insufficient detail in some areas. 

13 It would enable you to say, hey, there's five

14 studies on this; the general picture is da,

15 da, da; go look at the table.

16 I know tables would get pretty

17 long, but I think the text itself would be

18 shorter. So, the story may come through. You

19 don't have to wade, swim through all the

20 details.

21 I do think that there is another

22 case in that the old studies in most cases are
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1 summarily summarized, and with excessive

2 attention put on the new studies. So, I think

3 that that could be dealt with. In some cases,

4 a new study, I mean even really good new

5 studies, I mean I joke about the frog, but

6 there are some reasonable new studies that are

7 there, but they don't really say anything that

8 the old studies didn't say.

9 So, again, I think in some cases,

10 when you are talking about new studies, you

11 say, well, they are similar to the old study. 

12 When you talk about the old studies, then

13 there's the new study. The new studies refer

14 back to the old studies. So, there is a lot

15 of this overlapping, this duplication, when

16 you have a separate section.

17 There is also a lot of duplication

18 with the summaries. And we have had extensive

19 discussion about Chapter 2 and about its

20 being, at present, it is almost a total

21 duplication.

22 In fact, here in my preliminary
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1 comments, until I heard this, I was saying,

2 well, just take it away; throw it out. But

3 now, with this discussion we have had, I think

4 that it has hope and it could have value.

5 There are other areas where there

6 is a lot of overlap between MOA sections,

7 effects sections, and susceptible subpops. In

8 some cases, a given paper might apply to all

9 three, but it is only quoted in one place. 

10 So, I think the full story doesn't come

11 through.

12 In other cases, you have the

13 effect, and the effect chapter actually talks

14 about MOA. And, then, the MOA chapter talks

15 about effects. And, then, susceptibles

16 chooses some of those to talk about it even

17 more.

18 So, I think there is a lot of

19 duplication of the same study. And this is

20 really, really difficult to deal with because

21 you almost have to have a susceptible chapter

22 -- as I said before, I think your MOA could be
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1 integrated with the effects, so you didn't

2 have to duplicate it. But, I mean, it is

3 difficult.

4 Maybe if you have kind of got in

5 your mind that you needed to duplicate on the

6 big-deal studies, that might shorten it some. 

7 So, I mean this is very difficult because,

8 too, at the end of the day you want to walk

9 away with a clear understanding of the

10 exposure dose response. And when I say

11 "exposure", I mean concentration and duration

12 and dose-rate-type sorts of things. And so,

13 I mean I defy you to get a good sense of that

14 outside of the ever-popular FEV1 studies.

15 DR. SAMET: Michelle?

16 DR. BELL: Yes. So, I am going

17 to, hopefully, not be lengthy because Judy has

18 already said a lot of my points.

19 I actually think it is appropriate

20 for this document to be painfully long.

21 (Laughter.)

22 I mean there is a huge amount of
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1 scientific literature. And I think that if we

2 try to err on the side of making it too brief,

3 I think that we have done a disservice to the

4 science. I think that when you go through

5 this document, you really need to see the

6 incredible amount of work that has been done,

7 the incredible amount of evidence that is very

8 compelling.

9 And I like that the document is

10 kind of long. So, I don't think its overall

11 length is a problem. I mean we have already

12 talked about Chapter 2 and summaries. So, I

13 won't go into that. But once that gets taken

14 care of, I think it is fine that this is long.

15 However, it is kind of uneven. 

16 So, there are some places where you have

17 incredible amount of detail and some places

18 where things are really kind of glossed over. 

19 And I think part of that is just, due to the

20 length of the document, you had different

21 chapters being written by different people.

22 And so, in my written comments and
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1 others, you are going to get some specific

2 examples of things that could be lengthened or

3 shortened up. And I will just give a couple

4 of quick examples of what I mean now.

5 So, like there was a sentence in

6 the first chapter that said, "Typically, only

7 information that had undergone scientific peer

8 review and had been published or accepted for

9 publication was considered." I went up and

10 down this document trying to figure out what

11 does that mean, that you're typically only

12 including peer review documents, but what kind

13 of non-peer-review literature is in here? I

14 have actually like tried to find out. I still

15 don't know.

16 But that is an example of

17 something. You can't just make that statement

18 and, then, leave me hanging. I want to know

19 why is non-peer-review literature in here and

20 what is it. So, that is an example of

21 something. There are a lot of places where I

22 think you want to make sure you don't leave
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1 people hanging.

2 And an example of something that

3 is incredibly detailed is Chapter 3. I mean,

4 if you look at the detail in Chapter 3, all of

5 which is really wonderful, it is so far out of

6 balance with the rest of the document. I mean

7 it really stood out to me.

8 I mean there are 20 maps of cities

9 that show where their ozone monitors are. You

10 don't have that level of detail for anything

11 else in this chapter. There are 15 figures

12 comparing time series of GEOS-Chem ozone

13 estimates to measurements. You know, I think

14 one is probably fine. And nor is there any

15 text describing what I am supposed to do with

16 those 15 figures? It just goes on and on and

17 on.

18 So, it is not that that

19 information isn't useful, but I think those

20 are two examples of a place where you really

21 want to think about, are you making your key

22 points and a place where you really want to
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1 reel it in maybe about those key points.

2 So, finally, on the issue of the

3 duplication, it has already been mentioned. 

4 I know that is going to be taken care of when

5 someone goes through to kind of make these

6 chapters match.

7 And on the issue of tables, I know

8 a lot of people didn't like the criteria

9 document kind of mammoth tables at the end. 

10 I always like the tables. I thought they were

11 incredibly useful. I thought they were a

12 phenomenal reference. I mean I would go to

13 them over and over. I don't think there is a

14 better way to do it.

15 So, I agree that the tables are

16 useful. Even if you end up with like these

17 30-page tables, which you will, I think that

18 is going to be more useful, more clear, more

19 systematic than having the text go on and on. 

20 So, I think that when you add the tables, if

21 you decide to add them, they are going to be

22 very, very lengthy, but, then, you can cut out
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1 a lot of this text.

2 So, some of the concerns I had

3 about Chapter 7 with long-term exposure, you

4 won't have to go through every sentence and

5 add in three months, two weeks, and so on. It

6 will be in the table, and some of the tables

7 already have that kind of information.

8 So, I, again, just highly support

9 Judy's comment to add in the tables, even

10 though I suspect this was in response to the

11 table backlash that some people had. Is that

12 true? But I think that the tables work, work

13 really well, and that it doesn't work without

14 them.

15 So, those are my comments.

16 DR. SAMET: John?

17 DR. BAILAR: I agree with Judy

18 about the value of adding tables. I would add

19 adding some figures where they are

20 appropriate.

21 Another way that you might deal

22 with length is to put parts of this, maybe
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1 quite a few parts, in appendices. Legislative

2 history is an obvious candidate. That whole

3 bunch of maps in Chapter 3 is a candidate. 

4 There may be some others that EPA could

5 identify, so that the interested reader will

6 have them when they are necessary, but they

7 won't get in the way of the readers who want

8 less in the way of detail.

9 I do not entirely agree with Fred

10 about the location of a summary. There may be

11 a few readers who will look for it in the

12 beginning, as I would, and there may be some

13 who would like an overall view of what is in

14 this document as a whole before they go to

15 individual chapters that may be of special

16 interest. And again, I am one of those.

17 So, I would support keeping maybe

18 the 20-page summary at the beginning. Maybe

19 the equivalent of Chapter 2 could go at the

20 end. So, I am not sure how much we agree or

21 disagree.

22 DR. SAMET: Fred?
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1 DR. MILLER: You are saying

2 exactly what I was getting at. Really, that

3 is what I meant to come across.

4 But I like what Michelle brought

5 up and reinforced about the tables. In

6 particular, it would allow you to interpret

7 and describe what the collection of studies is

8 showing in the text, instead of having to say,

9 "Jones, et al., exposed 26 people to" blah,

10 blah, blah, blah, blah. Okay?

11 The bottom line, "This collection

12 of studies shows that ozone affects PM in

13 flux, and this is important relative to

14 inflammatory responses that have been shown in

15 animals, humans," blah, blah, blah. And that

16 tells the story, and the tables allow you to

17 do that.

18 Whereas, right now, a lot of the

19 text is having to describe that. Now it would

20 be able to become more interpretative and

21 discuss really the highlights of what is the

22 take-home message. And so, I think it is the
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1 way to go.

2 DR. SAMET: Go ahead. Go ahead.

3 DR. NEUFELD: I would just say the

4 other thing, too, to help the clarity of the

5 entire document is I think a standardized

6 format for the chapters. Decide what you want

7 in the beginning, in the middle, and the end,

8 and, then, we talked about having your chapter

9 having a summary. Decide whether you want to

10 have interior portions coming to some

11 conclusion and, then, final ones at the end.

12 But if you adopt a consistent

13 format, it will make the readability improve.

14 DR. SAMET: Okay. Peter?

15 DR. WOODBURY: Well, I have heard

16 enough comments here that I am sure I will be

17 repeating what someone said already.

18 But I think it is important to

19 have a summary chapter of approximately the

20 length of Chapter 2 that includes the main

21 conclusions. So, Chapter 2 does that now.

22 I think there is a structure here
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1 with the causal relationships. So, these are

2 essentially, I guess the jargon I would use

3 would be these are knowledge claims. That is

4 the level of integration that I think is

5 appropriate for this document.

6 I think it is unrealistic to

7 expect that a summary of the state of the

8 science, I don't think that is going to lend

9 itself to an extremely high degree of

10 integration. We have disparate pieces of

11 knowledge.

12 We have a whole bunch of disparate

13 experts in this room. And I would mention

14 that few of us have really dug deeply into

15 every chapter in here. If we aren't doing all

16 that, then I think the audience for reading

17 this entire document is rather small.

18 The audience for reading something

19 that is 50 pages or so is much larger. I

20 think when you go to the two-page Executive

21 Summary, you have no room for definitions. It

22 becomes very, very difficult, as you have
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1 discussed. That may be important.

2 And I think that the two-page kind

3 of summary can really just be the knowledge

4 claims without definitions of terminology,

5 without explanation of how they were arrived

6 at. So, it is essentially a list of the

7 conclusions of the main knowledge claims.

8 So, I guess I would say I am in

9 favor of something like Chapter 2. I think it

10 does need to be linked very well with the

11 remaining chapters. And whether the remaining

12 chapters are called annexes or something else,

13 I think there needs to be a very clear way to

14 get there.

15 One way may be by organizing it by

16 these knowledge claims. So, for each of the

17 knowledge claims in Chapter 2, then it tells

18 you the page number to go in the rest of the

19 document to understand how that conclusion was

20 arrived at.

21 I think it is inevitable there is

22 going to be some duplication throughout this
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1 document. So, I am less concerned about that

2 than that there be, again, a readable summary

3 of the knowledge claims with clear linkages to

4 the supporting evidence for those.

5 DR. SAMET: Okay. Thank you.

6 Anybody on the phone, comments?

7 DR. WEATHERS: Not here.

8 DR. STALLWORTH: Chris just mailed

9 you some comments.

10 DR. SAMET: Okay. Chris, do you

11 have comments? No?

12 DR. FREY: I don't think I have

13 anything substantially more to say, except I

14 am in the camp of kind of trying to keep

15 Chapter 2 early in the document.

16 I was wondering about, I kind of

17 like the idea of a two-page overview and maybe

18 something that is more like a story of what

19 this document is about. I don't see why that

20 couldn't actually be the first couple of pages

21 of Chapter 2. Then, the current meat of

22 Chapter 2 probably could be a little bit
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1 shorter.

2 I am thinking that each of the

3 subsequent chapters ought to close with some

4 clear findings. If that were done, then

5 Chapter 2 wouldn't have to repeat a lot of the

6 technical support for the findings. It could

7 just echo the findings and be more concise. 

8 Then, that would allow maybe some more thought

9 to be given to the synthesis and the

10 integration.

11 DR. SAMET: Okay. Thanks. I am

12 going to summarize as follows:

13 We have given you many ways to

14 organize the document, but we don't have a

15 preference. And the document should be

16 neither too long nor too short.

17 (Laughter.)

18 I think we are done, but we have a

19 little bit more work to do.

20 I am actually not going to be here

21 tomorrow except by phone. I am flying back

22 tonight because I am leaving for France
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1 tomorrow night from LA.

2 I think Chris or --

3 DR. STALLWORTH: Chris will chair

4 tomorrow.

5 DR. SAMET: Chris will chair,

6 unless his illness keeps him away. And

7 otherwise, we have reserved backup plans here.

8 One thing we want to do is just

9 look at setting a date. So, we will need to

10 discuss our draft letter by teleconference,

11 and we need some time to announce that. There

12 will likely be some exchanges amongst the

13 three or four people who are writing these

14 different sections together, and that will

15 take several weeks. So, we are probably

16 looking at potentially the week of July 4th

17 perhaps to hold that conference call. And

18 setting aside the day of July 4th, although

19 that may be available --

20 (Laughter.)

21 Is it a federal holiday?

22 DR. STALLWORTH: Yes.
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1 DR. SAMET: Setting aside that

2 day, if everyone will do something a little

3 more refined, but with that week, likely most

4 people have one day of availability. I think

5 that is really the question, and we will have

6 to hone down.

7 DR. STALLWORTH: Jon, just pick a

8 date and we will see if people are --

9 DR. SAMET: All right. I am now

10 going to pick a date, a favorite date. How

11 about July 6th? That is the Wednesday. July

12 4th is Monday.

13 DR. STALLWORTH: 10:00 a.m.

14 Eastern Time. Wednesday, July 6th, 10:00 a.m.

15 Eastern Time.

16 DR. SAMET: Can't do it? Well, we

17 will send out a couple of days that week. I

18 know Holly wants to get this done. It is a

19 challenge. We will send out a couple of days

20 that week.

21 DR. MILLER: Anytime you have a

22 holiday with the week, people take vacation
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1 and you really need to go to the next week in

2 July, July 11th and 12th, or something like

3 that.

4 DR. SAMET: Okay. I told you,

5 Holly, this wouldn't work.

6 DR. STALLWORTH: Yes. All right.

7 DR. SAMET: So, we gave it a try. 

8 So, anyway, just again, let me go through the

9 schedule of events with you, which is that I

10 asked that the groups, the leaders, summarize

11 and synthesize the comments.

12 Remember that all the comments

13 don't have to be brought forward from the

14 individuals because your individual comments

15 will be included. So, it is the draft

16 response to the charge question that needs to

17 be prepared. If somebody could take the lead

18 in assembling that, based on what was written,

19 plus the discussion here, and then circulate

20 that to your colleagues, I think with a few

21 iterations smooth that out. Then, when you

22 are ready, send it on to Holly.
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1 DR. STALLWORTH: Right, and you

2 need to be ready. One week from tomorrow, is

3 that too soon? You need more time? Okay, the

4 following Friday.

5 DR. SAMET: So, let's say two

6 weeks.

7 DR. STALLWORTH: In two weeks.

8 DR. SAMET: Two weeks -- and

9 again, Holly will send out a note -- to get

10 these to Holly. Then, she and I will work on

11 the letter, and there will be some chance

12 to --

13 DR. STALLWORTH: So, that will be

14 due June 3rd.

15 DR. SAMET: June 3rd. We will

16 work on the letter, and you will have a chance

17 to look at that, of course, before --

18 DR. MILLER: Jon, can you give us

19 some guidance? Like when a specific question

20 was asked, two or three paragraphs seem to me

21 the amount that you would be --

22 DR. SAMET: Right, right. Yes, we
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1 have tried to keep these relatively brief, and

2 more detailed comments really would stay with

3 the individual's responses.

4 So, I think we have gotten our job

5 done for the first day. I want to thank

6 everybody for their hard work. I mean there

7 is so much to talk about, and I think our job

8 here really is to hone in on what is most

9 critical and to give guidance to the agency in

10 making the revisions.

11 You are back at 8:30 tomorrow

12 morning to discuss these two documents that

13 will be presented.

14 DR. STALLWORTH: The scope and

15 methods.

16 DR. SAMET: The scope and methods.

17 There will be public comments.

18 DR. STALLWORTH: Just a couple,

19 yes.

20 DR. SAMET: A couple tomorrow as

21 well.

22 For those of you not familiar with
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1 Chapel Hill, there's lot of restaurants out

2 the door, and that is one advantage of being

3 here.

4 We have not lately been doing

5 group dinners, but please feel free to form

6 up, you know, dosimetrists with dosimetrists.

7 (Laughter.)

8 I suspect from the locals we can

9 get some restaurant recommendations.

10 So, thanks to everybody for the

11 hard work, to the public for comments, and to

12 EPA for your presentations. Thanks.

13 (Whereupon, at 5:08 p.m., the

14 foregoing matter went off the record.)

15

16

17

18

19

20

21

22
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ability 121:17,19

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281:12,13 289:15

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absolutely 65:7

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absorbed 157:20

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abstract 56:19 58:5

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acceptable 81:7

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accepted 413:8

access 55:8 60:10

accompanied 16:5

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accumulated 36:11

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7:24

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adopted 194:14

adult 123:10

adults 351:4,5,9

advance 14:22

advanced 9:2

268:11

advances 398:21

398:21

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345:14

adversity 114:3,8

114:12,15 119:14

119:15 120:11

advice 8:20 24:10

24:11,18 25:3,5,7

28:5,14,15 197:2

advisory 1:3 2:17

8:11,14,17

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309:4

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age 238:20 247:22

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361:20

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17:10 21:1,2 22:6

25:7 61:6 86:8

211:17 223:6

230:18 340:2,14

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aggressive 154:4

154:16

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290:11,14,14,18

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artificiality 301:8

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atmosphere 92:16

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155:3 163:21

205:9 385:16

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attempt 113:16

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attempted 110:6

attempting 32:7

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attention 232:19

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attenuation 249:18

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attributed 80:17

audience 380:8

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audiences 395:6

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audio 8:9

audit 197:10

augment 31:10

August 71:3

author 241:3

authors 82:1 117:4

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auxin 177:15

availability 373:4

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95:2 143:19,22

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68:6,14 69:4,5,7

70:9 71:1 72:5

73:3 74:20 75:8

75:16,16,17 77:12

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276:11 299:7

304:21 314:15

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368:13 377:11

389:2 400:19

405:5 409:14

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background 11:17

11:20 12:10 39:16

43:11 45:2 69:19

89:17,18,18,19

90:11 93:2 95:15

95:19,22 96:13,19

96:21 97:15 98:1

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100:1,7 128:4

130:19 136:10

146:14,19 147:22

152:12,13,14

153:3,7,9,21

154:19 156:22

203:4,8 285:3

289:17,17 291:8

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backgrounds 39:14

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backlash 416:11

backup 424:7

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bad 225:13

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103:7 105:13

106:10 121:10

122:10,21 293:4

328:22 337:15

338:4 399:21

416:17

balance 10:2 46:11

156:15 236:18

414:6

ball 408:6

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Balmes 310:14,15

bar 120:20

barely 73:10

base 90:12 92:22

93:5,9 94:4

based 33:7 35:16

49:14 68:10 76:13

83:1 85:6 91:18

97:5 149:2,3

159:4 170:22

207:10 218:22

220:10 237:3

243:6 258:16

261:5 274:6 289:2

324:7,9 325:22

331:3,14,16

351:17 359:20,21

426:18

baseline 96:9 125:4

146:21 334:12

basic 238:1 368:13

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basically 107:18

118:15,22 127:10

139:1 193:15

235:4 240:18

275:10 332:2

349:17 367:21

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basis 31:18 69:9

177:17 291:13

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bear 22:1 287:4

bearing 335:2

beat 114:4 244:1

beats 244:2

becoming 254:3

beefed-up 195:18

began 20:10

beginning 60:7

176:14 240:2

250:10 265:7,22

280:21 322:19

334:4 386:9

404:19 417:12,18

419:7

begins 78:6

begs 288:8

behalf 78:20 88:22

behave 133:18

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belabor 107:8

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155:21 319:5,12

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belongs 396:5

beneficial 224:15

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benefit 18:14 21:8

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222:14,21 223:7

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best 38:17 109:10

221:20 259:8,9

275:22 321:8

399:12,16,17

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beta 142:19

better 53:13 109:5

130:21 134:11

135:4 140:5

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157:21 167:1,10

167:15 171:8,9

177:1,3,4 182:2

210:20 253:22

261:19 264:16

290:20 295:22

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373:9 378:6,11

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274:12 375:19

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115:22 119:5

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big 59:11 124:20

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148:3 155:1,7

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109:12 161:3

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182:1,15 185:14

193:17 195:11

202:12 245:19

247:20 260:4

264:4,12 333:12

350:11 391:14

418:4 426:13

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29:5 31:16 37:18

37:21 51:6,20

80:13 81:8 87:17

88:4 274:17

288:16,20 315:16

315:22 316:4,8

brush 127:13

bryophytes 167:21

BR6 398:5 400:19

build 26:11 64:5,8

64:9 143:13

building 350:21

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builds 166:3

built 62:8 180:4

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bulk 238:8

bullets 401:22

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bunch 144:20

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buried 297:14

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business 148:9

buys 55:14

byproducts 235:8

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334:7 361:21

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called 24:2,3 59:2

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calling 10:12

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CalNex 98:14,22

caloric 347:10

Cambridge 4:5

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campaign 98:11

campaigns 149:3

CAMx 93:12,14

Canada 43:19 92:1

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Canadian 90:22

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candidate 417:2,3

capabilities 19:20

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capture 60:9 62:1

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captured 57:6

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capturing 77:5,7

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ceased 334:19

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center 14:7 109:18

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central 197:9

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174:7 176:7

203:13 222:14

223:9 232:7

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314:18 318:7

341:6 348:18

355:11 357:8,14

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238:20 267:20,20

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Chadwick 73:22

chair 1:13,15 3:9

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challenge 56:13

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chamber 156:18

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290:13 307:20

313:8 315:3 317:9

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345:11,17

chambers 169:2

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201:10

chance 161:11

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373:8 427:11,16

Chancellor's 1:12

Chang 334:11

change 5:17 17:11

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53:14,15 58:12

80:11 82:2 117:10

141:8 154:22

155:1,4 175:3,4,4

175:6 195:8 198:5

201:14 202:1,7

203:16 206:5,8,17

207:10 208:9

252:14 259:21

260:5 272:6,7,11

272:12,15 273:20

274:5,9 290:6

297:18,19 314:9

314:11,14 315:13

320:4 337:7 363:9

363:10,15 369:19

384:22 392:21

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402:19

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58:6,9 175:11

195:19 244:8

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196:12 198:7,9,17

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chartered 8:19

chase 402:9 406:10

check 66:2 94:13

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childhood 47:4

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chime 230:2

China 154:3

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Chittenden 70:18

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choice 139:22

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choices 326:10

choose 321:3

chooses 410:16

choppy 300:10

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Chris 6:5 10:13,15

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163:1 186:22

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chromosome 348:7

chronic 242:14

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chuck 263:21

chunk 263:21

cilia 244:1

circle 296:19

circled 47:17

circles 48:1 394:9

circuit 28:20 32:20

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circular 107:15

circulate 426:19

circulation 99:18

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circumstances

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cite 52:11 57:9,18

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cited 54:18 57:1,2

58:18 63:9,11,13

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cities 142:22

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citing 235:16

city 114:1 142:21

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claim 87:4 216:11

claims 420:3 421:4

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clarification 17:19

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clarifications 19:5

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clarified 185:9

clarify 367:8

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clarifying 67:4

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37:7 164:8 192:7

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71:6,10 217:6

225:13 298:12,13

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desired 39:22

despite 295:10

detail 238:3 268:9

274:4 277:10

287:16 335:7

390:18 408:12

412:17 414:4,10

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detailed 59:3 110:1

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determinants

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determination 4:17

41:12 110:17

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determinations

30:9 41:8,19 42:8

42:12 233:6

determine 82:17,21

97:11 176:2

determined 10:5

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determining 72:21

97:22 115:12

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detract 174:12

develop 52:18

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developed 20:11

54:22 105:20

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developers 53:7

developing 154:17

186:1 223:4 364:9

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172:12 250:7

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developmental

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Devlin's 301:8

devoted 95:14

diagrams 378:9

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dichotomous

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dichotomy 309:14

311:2 318:5

dictate 245:21

390:3

diesel 138:17

diet 285:17 347:3

differ 29:15 329:17

382:11

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30:5,19 75:2 99:3

122:4 125:3

142:21 341:9

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differences 45:20

179:10,14 255:9

262:5 275:3,5

308:22 329:20

different 19:2,9

48:8 54:2 56:1,1

59:13 60:1 87:19

89:17,20 90:11

107:6 110:7 111:4

118:16 133:5,7,16

134:6 143:3 151:2

160:1 161:4 164:1

176:21 183:2,3,18

184:8,17 186:11

189:21 191:11

200:22 207:22

219:19 222:16

232:2 233:19

240:10 241:21

252:2 253:2

255:15 261:12

266:12 268:19,20

269:19 270:8

273:20 279:12

280:12 285:16

291:14,15 314:2,3

317:17 319:17

320:18 321:19

339:4 357:3,4,10

359:19,20 362:19

370:4 372:5 374:7

375:13,22 380:14

390:10 392:8

395:6 397:7,8

399:11,21,22

400:16,16 405:2,8

407:18 412:20,21

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differential 346:14

differentiation

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differently 133:18

141:17 371:5

differs 109:9

difficult 74:16

190:21 241:12

276:17 307:15

410:20 411:3,7

420:22

difficulties 60:18

difficulty 146:3

149:19

diffuse 170:5

diffusion 150:7

238:10 268:8

digest 380:14

dilemma 250:8

282:2

diminished 220:7

dinners 429:5

direct 134:13

137:19 166:21

174:20 198:11,15

201:9 202:6

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direction 160:14

175:6 176:3

184:11 294:8

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130:3 174:7

205:20 243:17

248:9 294:15

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directly-measured

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Director 10:20

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disability 350:17

disadvantage 166:4

disagree 278:6

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discerning 41:13

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discipline 58:20

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disease 124:8,12

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disparate 420:10

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dispel 188:9

dispersion 238:9

displacement

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dissatisfaction

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District 28:19

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91:16 131:14

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diverse 39:15 354:6

diverts 407:3

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doctorate 87:16

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38:3,8,13 39:1,17

40:9,19,22 44:4

47:20 50:12 54:6

54:19 56:4 57:19

63:8,13 64:20

75:22 84:6 86:12

106:17 116:9

117:3 118:2,3

120:19 123:16

125:13 130:6

138:9 144:9 156:2

156:5,16 157:4,17

159:10 178:17

181:1,20 190:2

193:11,13 212:2

221:10 222:4,5

224:18 226:10

231:19 232:14

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268:9 287:22

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Donovan 181:13

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dose 45:21 122:6

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238:21 241:16

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258:5,17 260:10

260:16 263:3

265:3 273:19,21

274:8,11 285:1

288:4,18 291:11

291:14 349:2,3,6

359:16 361:21

362:1 364:3,15

367:2 411:10

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101:2,6 102:13

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105:14 106:10,13

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107:1,3 114:20,22

116:11 118:9

120:5,7,8 121:8,9

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122:10,21 124:1

124:15,17 125:14

125:21,22 126:1,4

126:6 127:3,5

132:7 144:16,17

155:12,21 158:16

158:18,20,21

159:7,8 160:16,20

161:13 162:1,22

163:2,4 164:8,9

165:5,7,11,16,17

165:19 166:2

168:5,7 175:16

176:1,4,5,7,11

182:9,11 186:13

186:14,17,18

188:2,21,22

189:13,15 190:3,5

190:6,7,19 191:4

192:13,15,19,20

192:21 193:2,3

194:6 196:5,6

197:4,22 198:7,9

198:10 199:17,19

203:18,20 208:20

209:2,3,8,9,10,12

210:3,10 215:6,8

218:12,14 221:5

222:2 223:11,21

224:3,6 225:8,9

226:21,22 229:19

229:20,22 231:9

231:12,15 232:13

234:4,5,7,8

235:20 236:10,11

237:5,12 249:3,5

250:5 251:12

256:11,12 262:12

264:5,7,8,10,14

273:1,3,4,6,8,10

273:12,13 274:15

274:16 276:4,6,7

276:9,11,13,22

277:6 279:8

281:11,20 282:1,6

282:8,21 283:6,8

286:21 287:1

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293:2,4 296:13

306:13 307:18

309:20 310:2,4,14

310:15,18,20

311:7,8 312:6,11

312:15,17 313:13

313:19 314:5,7,18

315:16,22 316:4,8

316:10,13,14,22

317:5,22 318:1,12

318:18 319:5,10

319:12,13,14

328:20,22 331:8

331:10 336:9,11

337:15 338:4,20

339:14 340:22

341:19,21 342:1,8

342:13,17,18,21

343:1,3,5,7

348:11,12 352:17

354:20 355:2,4,6

355:7,9,11,14,15

355:17,18,19,21

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356:22 357:1,17

358:1,3,5 359:7

359:11 360:11

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370:8,11,14,16,18

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371:15,17,19,20

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dug 420:14

Duke 14:6

dump 381:19

duplicate 411:2,5

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duplication 409:15

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296:4,5 317:9,19

330:9,15 337:19

338:10,10,12,14

338:16,17 340:7,8

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123:7,9,14 135:9

142:14,18 143:3

151:19 166:1,14

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174:7 175:22

182:22 184:14,19

185:5,8 189:20

198:5,15 199:12

200:5 201:14

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205:22 210:16

212:6,19 219:13

220:10 235:9

239:10,14 244:12

246:21 247:8

257:4,8 258:3

259:11 263:1,13

264:1 265:20

278:11,15,16

279:15 280:22

281:6,7 292:11,15

293:11,12,18

297:8,9 300:8

301:14 302:7,10

303:10,14 304:15

304:22 305:13,16

311:10 317:11

318:19 321:15,22

322:2 330:12,13

331:2 333:10,11

333:15 334:5,7,16

335:2,20 341:2,3

347:13 350:7

365:9 377:17

378:5 380:16

384:16 388:10

391:12,13 392:20

398:6 401:14

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effectual 103:13,20

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effort 36:8,19

93:18 306:7 309:9

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eight-hour 69:3,7

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74:14 75:15 80:20

81:6,14 82:11

83:13,22 84:5,17

89:15,19,21 90:12

91:8,21 92:2,6,9

92:10,19 103:10

104:1 105:18

123:1 144:8

160:21 164:21

190:14 225:6

226:13 230:12

231:8 242:14

294:20 303:11

304:1,7,19 315:2

320:5 326:10

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417:4 429:12

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85:17 93:18 319:7

319:16 324:21

epa.gov/hero 52:15

epi 45:17 118:20

253:4,14 296:16

296:17 297:15,21

305:16 317:21

331:11 350:16

351:19 363:21

375:11 376:18,22

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equal 69:6,8,13

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error 109:21 110:2

110:8,11,12,16

113:4,7,13 121:14

122:7 228:19

376:16

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escaped 248:22

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49:5 144:4 163:17

166:15 178:14

185:22 218:20

219:6 259:6 297:5

345:17 375:5

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104:19 105:3

110:18 116:15,18

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339:16,21 340:3,4

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133:9 135:5

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161:10 178:7

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give 48:22 66:21

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236:7,15 237:2

243:3 245:13

257:8,22 271:11

274:16 321:14

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given 9:2 34:20

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103:12 117:3,11

120:17 121:11

130:4 149:21

150:2 158:7

162:12,19 216:5

216:21 227:16

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255:1 324:16,22

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353:22 357:20

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423:9,13

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Glacier 69:13

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243:19 245:2

246:18 247:1

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251:10 262:13

267:4,8 268:9,12

271:18 272:18,21

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308:11 318:14

319:18 328:14

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356:10 357:18

373:12 379:11,20

381:16 384:4,7

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276:11 285:10

291:12 303:7

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grandmother

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grids 90:3

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groundwork

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haphazardly

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helpful 138:22

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helping 157:5

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Hemisphere

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Henry's 238:10

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181:4,6 187:3

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higher 72:9 78:5

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highlight 30:20

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holding 66:20

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holiday 424:21

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illustrating 44:11

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immediate 17:20

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immediately

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immense 283:12,16

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impacted 174:15

impacts 18:18

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implement 154:4

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impression 64:21

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improve 211:6

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improvements 90:9

inaccurate 179:17

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incidence 123:11

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infections 350:15

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325:5,21 346:3

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informative 107:14

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infringing 65:12

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Lydia 3:13 18:15

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macrophage

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macrophages

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macro-use 104:9

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magnitude 112:11

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main 15:21 110:4

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Maine 71:18,18

maintain 238:3

maintained 90:20

maintaining 9:10

major 30:21 86:8

118:11 123:20

128:7 147:15

166:14 167:19

228:18 243:2

250:21 277:5

280:15 296:14

300:9 333:14

334:8 349:19

majority 80:18

making 9:11 35:14

36:6 74:21 107:17

134:12 206:20

236:7 251:5 309:9

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mammoth 415:9

man 304:19

manage 56:12

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manifests 108:1

manmade 43:19,22

manner 30:11

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manually 61:13

manufacturing

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map 137:8 207:17

maps 77:10 414:8

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march 27:9,16,18

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Margaret 275:9

margin 354:14

marine 97:15

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markers 114:8,10

114:10,11

marks 257:14

marry 402:13

mass 236:1

Massachusetts 4:5

masses 136:16

massive 65:1

match 130:8 415:6

material 59:2

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matter 25:1 36:16

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max 77:17 91:17

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maximality 68:22

maximum 37:13

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maximums 164:16

McCoy 313:1

McCoys 312:21

McDonald 286:14

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McLaughlin 170:9

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McLaughlin's

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MDA 76:13

mean 37:10 61:5

65:9 69:3 80:1,11

80:16 81:4 82:2

91:18 103:17

111:7 118:17

120:2 121:6,19

122:1 124:5

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157:18 160:18

172:1 173:10,18

173:19 175:17

186:5,6 191:20

212:8 213:20

221:12 223:11,20

225:22 226:9,12

231:21 233:17

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meaningful 68:16

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meaningless 92:13

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measure 98:3

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measuring 95:14

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meat 191:19

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mechanism 79:22

122:18 172:7

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mechanisms

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mercury 135:20,21

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merit 107:21

message 100:20

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metadata 56:20

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meta-analyses

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meteorology 90:1

methane 154:12

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method 82:11

methodological

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methodologies 73:6

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methodology 188:8

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methods 13:5

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microgram 244:19

micrograms

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microns 243:8,13

microphone 243:3

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micro-level 104:7

middle 49:12

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midst 282:15

mid-latitudes

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mid-nineties 222:7

mid-part 142:4

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mild 333:8

miles 133:4,6

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122:9 159:8 196:6

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235:20 237:12

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273:12 276:4,7,11

282:21 305:1

311:8 313:19

316:22 336:11

342:8 348:12

367:18 373:3

389:7 404:16

418:1 425:21

427:18

million 28:4,8,11

28:17 160:9 226:2

242:13 350:19

352:2

mind 65:2 66:5

122:17 192:22

221:8 237:9

317:20 341:8

351:19 411:5

minds 340:2,10,12

401:11

mined 137:7

minimize 113:16

minimum 177:21

240:22

mining 162:13

minor 15:8 143:5

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294:6 345:18

346:2 347:14

minus 290:9 291:3

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minuses 351:7

minute 104:9 244:2

269:11,21 270:2,6

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350:4

minutes 9:14,16

31:17 66:19 67:1

67:2 100:10

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mirror 377:15

mischaracterizat...

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misclassification

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misconceived

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misleading 220:5

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326:7

missed 278:20

missing 157:17

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304:13 311:17

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mistake 173:14

187:22

mistaken 187:18

misunderstanding

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Mitchell 138:11

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mix 130:8 317:15

mixed 44:18 135:1

183:16 271:13

385:22

mixed-species

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mixing 97:1,7

142:3 244:3

mixture 239:14

MOA 278:8,12,18

278:21,22 279:3,4

300:8 410:6,14,14

410:22

mobility 325:16

mode 6:9 39:9

45:19 83:15

239:13 240:2

253:2 256:19

257:9,15,18 258:1

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259:2 263:3,21

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374:20 378:1,4

model 44:1,10,12

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90:3,15 94:4

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145:18 146:10,16

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150:21 156:11,19

157:20 158:11

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182:17 183:8

184:9 236:22

241:20 275:7,12

275:14,18 281:2,9

287:15,17,18

289:2,3 330:10,14

334:14 338:11

378:11 398:11,14

404:3

modeled 74:16

90:9 130:9

modeler 199:22

modelers 200:4

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modern 118:6

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modification

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modified 93:22

modifier 109:13

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modifying 246:21

modulation 277:16

module 59:6 64:5

moisture 140:16

moisture-related

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moment 14:13

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Monday 425:12

Mondays 143:11

money 230:19

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monitor 133:3

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monitors 129:7

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monkeys 241:14,19

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monolayer 243:16

monoxide 97:20

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Montana 3:23 68:2

month 16:19 69:1

monthly 63:5 69:3

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months 34:3

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morbidity 330:21

morning 8:3 11:2,3

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morphological

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morphometric

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morphometry

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mortality 228:1

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mother 285:18

motion 237:14

mountain 99:21

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mountains 184:21

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mouse 275:18,21

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moves 339:16

movie 250:18

moving 27:22

33:19 41:1 42:17

45:10 48:19 56:14

58:22 74:20 84:4

210:3 344:1

399:18

MSA 337:1

Mt 134:14 137:2

138:11,12,13

139:8,9

mucous 243:22

256:6

muddied 357:15

muddle 354:8

muddled 353:16

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Muddy 357:6

multi 113:22

multiple 11:4 62:10

108:18 117:4

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245:3

multi-day 135:2

384:16

multi-month-type

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multi-pollutant

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murky 341:10

mV 308:20

N

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NAAQS 33:1 34:10

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nail 242:20

naive 189:17 288:7

name 18:4 22:14

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narrow 21:17

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national-scale

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natural 89:19

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nature 19:8 29:2

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NCEA 55:3,14

65:17 189:16

NCLAN 169:11,16

193:12,18

NCore 140:18,20

near 141:8 228:18

372:9

nearest 217:20

necessarily 50:3

154:3 381:4 393:1

403:3

necessary 147:9

417:6

need 8:12 20:7

40:19 88:8 107:7

115:11 117:18

120:19 124:4

126:22 128:17

129:12 130:17

135:19 141:20

149:15 153:1

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175:12 184:13

186:8 219:5

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232:19 235:12

247:17 254:9

255:7 262:16

267:9 271:9

279:20 292:19

299:19 306:22

307:9 315:10,15

336:1 344:22

354:19 362:7

366:9 380:8 382:5

387:12 388:13

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427:2,3

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negative 119:10

neighborhood

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neither 338:11

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NESCAUM 13:5

nested 44:9 90:3

net 52:16 54:1 55:4

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networks 172:8,8

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63:7 114:22

176:11 194:6

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314:7 371:17,20

382:9 383:20

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neutrophilic

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never 119:8 225:17

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new 15:18 17:13

19:15 29:15,22

30:7,15,18 33:8,9

34:22 35:9,11,21

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335:15 374:7

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new-onset 47:3

NHAP 237:1

nice 129:18 168:9

169:8 198:19

235:1 252:4

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375:15 379:22

nicely 168:15 235:4

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NICHD 336:5

Nicholas 80:21

81:9

NIEHS 12:10

night 424:1

nighttime 177:22

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nineties 222:6

nitrate 140:20

206:1

nitrogen 179:21,22

Niwot 99:22

NOAA 95:10

nod 137:14

nods 323:20

non 180:5 203:1

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340:8

nonlinear 248:4

non-chambered

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non-human 302:11

non-methane 90:18

non-negligible

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non-peer-review

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non-responders

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non-urban 131:16

NORC 12:18

normalize 246:7

normalized 244:18

normally 27:17

137:18

normals 318:4

north 1:12 11:7

43:20 44:9 45:7

71:16 89:18 90:7

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146:13 154:1

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northeast 142:10

northern 137:3

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nose 256:3

note 27:14 37:1

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noted 33:5 85:13

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notes 175:9 271:16

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notice 9:2 152:14

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notions 111:9

notwithstanding

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not-likely-to-be-...

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novel 251:22

November 26:13

NOwhat 141:7

NOx 44:14 59:19

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91:12,13 148:11

149:6,9 154:10

205:21,21 206:3

208:3,15,17

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395:18

NOx/SOx 159:5

NOy 141:3,6

no-threshold

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NO2 219:16,21

220:5

NQ01 346:8

NRC 85:14

Nrf2 347:19,21

null 84:10,19

number 20:1 38:3

56:9 63:10 64:13

69:4 71:6 83:1

85:17 97:16 98:3

139:12 150:5,11

171:7 173:15

174:1 181:2

201:11 220:15

222:16 240:14

347:14 350:16

363:13 399:14

407:19 421:18

numbers 59:6 71:5

240:3

numerical 150:6

numerous 57:2

174:5

nutrient 195:5

nutrition 360:20

O

OAQPS 18:16

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226:10 236:19

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OAQPS's 159:16

Obama 29:8

obesity 286:8

347:17

obliterated 352:3

observation 98:6

observational

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observations 23:22

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144:5 145:19

146:1,8 147:10

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obstruction 284:21

obstructive 318:2

obtain 144:9

obvious 417:2

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occurring 122:16

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Ocean 97:13

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offer 126:12 166:10

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ones 31:20 55:13

58:18 126:4 145:7

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one-hour 68:9

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ongoing 73:14 74:5

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online 19:14,16

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onshore 98:5

open 8:12 9:9 57:10

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249:19

opening 181:3

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opens 157:2 366:1

open-top 168:20

169:2 189:7 194:8

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operate 183:3

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opinions 42:9

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option 405:19

options 24:7,15,18

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ORD 33:8 139:19

order 3:2 112:11

135:6 220:9

224:21 380:8

orders 112:12

organic 44:15

236:1

organize 423:14

organized 216:22

organizing 261:12

380:1 421:15

organs 182:22

original 81:8 123:5

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originally 105:19

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ought 138:20 139:2

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ounces 337:7

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outdated 91:14

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outdoor 122:5

220:14 350:2

361:12 370:1

outdoors 228:14

234:17 365:16

outer 90:4 261:7

outlook 208:9

outset 254:9

outside 90:20

162:11 227:22

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358:19 361:13

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overdose 309:3

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percentile 150:15

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person 55:20

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129:20 169:11,18

170:13 172:7

173:12 177:16

186:1,21 193:19

194:4,19 199:19

200:22 201:5,16

202:5 204:3,9,10

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237:7 246:9

256:20,21 258:5

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262:4,5 272:7

280:3 285:1,12,21

286:3 288:4,18

290:4,5,6 308:12

309:14 313:4

314:16 316:15,18

342:5 343:2

344:20 345:1

349:2 353:22

358:2 367:10

411:10 416:10

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responses 15:22

16:5,12,13,16

174:6 177:8 180:2

183:10 255:15

258:3 310:6,13

418:14 428:3

responsible 125:10

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responsitivity

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responsive 57:15

179:3 364:8

responsiveness

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rest 60:13 113:18

114:18 116:9

120:18 141:16

156:2,16 169:7

182:4 189:10

193:16 250:18

374:14 375:20

379:5,10 383:7

390:1 403:9 414:6

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restaurant 429:9

restaurants 429:1

restriction 347:11

restrictive 123:21

restructure 283:5

restructuring 31:1

result 80:10 179:16

226:5 293:8

330:16 351:17

364:2

resulted 80:15

results 23:22 31:6

81:22 83:3 84:8

84:10,19 116:3

161:10 182:17

184:8 236:15,22

237:2 242:8 245:3

291:12 327:21

329:18,19 374:6

375:12 376:9

resumed 102:11

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retired 13:10

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retrospective

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return 88:12 196:7

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reverse 187:13

214:18 330:11

review 1:4 3:8

14:10 15:2 16:20

17:8 19:21 20:11

21:6,11,14 23:6

23:10 24:21 25:11

25:19,19 26:8

27:18,22 29:1,16

33:7,13,15,16,17

36:20 37:1,5,6,19

38:6,7,12 39:3

40:12 41:7,20

42:5 47:18 48:12

143:22 166:18

249:10 250:12

329:18 393:22

394:11 397:20

413:8,12

reviewed 9:22

23:20 84:7 85:12

86:4 252:12

reviewers 53:22

65:21

reviewing 11:7

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40:17,18 86:9

166:11 245:20

382:3 399:8

revise 139:21 380:9

revised 93:6 94:5

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revision 32:20

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revisions 28:1

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Ridge 99:22

right 20:7 27:12

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rigorous 85:20

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24:20 26:10,17,21

27:3 43:12 68:10

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91:9 92:15 117:11

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358:13,21 360:4

363:1,18 365:9

366:6,22 398:11

398:11 408:7,8

risks 300:13,13

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risk-of-exposure

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Riverside 12:2

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road 127:16 230:6

roadmap 389:9

391:2 392:16,17

roadside 214:17

roadsides 214:2

roadways 216:14

228:18 372:9

roaming 148:1

roar 63:22

robust 140:1

rock 154:12

rodent 305:18

role 177:19 246:20

room 162:19 200:4

241:4 272:17

280:8 285:2 295:4

420:13,21

ROS 172:8

Ross 113:19

roughly 16:3,10,19

26:7 27:18 34:2

45:8 117:3

round 139:20

140:14 142:9

398:2

rounds 35:6

route 401:7

routing 55:17

row 50:8

rubric 252:2

rule 27:10,11 28:20

rules 25:12 340:2

run 59:8 63:2 64:7

89:22 90:3 92:21

92:22 142:5,8

156:6

running 61:21

98:15 142:7

209:14 262:10

running-together

238:18

runs 91:8 137:18

rural 134:1 161:5

197:8 212:10,20

Russell 1:18 5:5

12:16,16 127:5

165:7,16

S

S 3:22

SAB 3:4 9:21

sacred 184:19

safety 308:15

354:14

sake 157:8

salt 208:7 226:1

Sam 4:13 67:8

78:14 94:13 95:9

146:20

Samet 1:13,15 3:8

4:22 9:17 10:9

11:1,2,12 14:9

18:8 29:13 32:16

33:21 34:5,17

36:7 37:7,15 52:1

61:2 63:6 64:15

66:2 67:16 72:16

73:9 74:2,9,12

76:9 78:10,16

79:3,6,11 85:15

86:2 88:12,20

89:7,10 93:20

94:8,16,19 95:1,5

99:20 100:10,13

101:6 102:13

105:12,14 106:13

106:21 107:1

114:20 116:11

120:5,8 121:8

124:15 125:14

126:1,6 127:3

132:7 144:16

155:12 158:16,20

159:7 160:16

161:13 162:22

163:4 164:8 165:5

165:11,17,19

168:5 175:16

176:4,7 182:9

186:13,17 188:2

188:21 190:3,6

191:4 192:15,20

196:5 197:4,22

198:9 199:17

203:18 208:20

209:3,9,12 210:3

218:12 221:5

223:11 224:3

225:8 226:21

229:19 231:9,15

232:13 234:5,8

236:10 237:5

249:3 250:5

256:11 262:12

264:7,10 274:15

276:22 279:8

281:11 282:1,8

283:6 286:21

293:2 306:13

311:7 312:6,11,15

312:17 313:13

314:5,18 316:10

316:14 317:5,22

318:12,18 319:10

319:13 328:20

331:8 336:9

339:14 341:19

342:1,13,18 343:1

343:5 348:11

352:17 355:2,7,18

355:21 356:5,19

356:22 357:17

358:3 364:16

367:12 369:6

370:8,14,18 371:2

371:15,19 372:2

372:14 373:14,17

379:16,19 382:8

386:15,22 387:2

389:6 390:5 391:4

395:10 397:12,15

398:4 400:18

401:19 403:14

405:21 406:6,16

406:22 407:8

411:15 416:16

417:22 419:2,14

422:5,10 423:11

424:5 425:1,9,16

426:4,7 427:5,8

427:15,22 428:16

428:20

sample 300:2

320:19 351:20

Sandeman 178:11

Sandy 170:9 171:9

179:5

Santa 231:10

satellite 151:4

satisfy 104:21

saturated 83:21

save 161:18

saw 119:17 402:4

saying 116:17,21

191:16 194:18

224:19 235:3

249:12 262:21

273:17 276:17

281:18 311:14

312:4 319:6,15

398:19 410:1

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scale 131:3 132:21

138:21 141:9

142:14 182:21

183:1 200:6,7

213:22 214:13

308:20 345:22

scales 131:4 144:7

167:2,8

scaling 309:1

scanned 331:11

scanning 233:2

scary 39:4

scattered 170:5

176:21

scenario 90:16

206:8

scenarios 90:8,11

91:6 93:21,22

94:2 115:5 207:5

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schedule 21:12

23:2,9 25:14

27:12,15 29:8

102:3 209:15

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schematic 278:2

Schindler 385:17

scholar-in-reside...

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school 13:17,17,22

47:6 216:16

361:14

science 2:17 3:11

20:13 21:10,22

22:1 23:11,14

24:6,10,13,20

26:15 31:14 33:8

33:9 35:5,7,9,21

37:4 38:1 54:4,14

119:16 143:19

148:6,8 157:9

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sciences 39:8 42:20

85:12

scientific 1:3 8:11

33:12,14 130:18

149:1 156:8,11,12

211:19 412:1

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scientifically 81:6

85:19 297:1

scientist 12:20 14:4

95:10

scientists 44:21

scope 23:19 26:3

428:14,16

scopes 16:21

Scott 183:7

screened 99:1

screenshot 54:9,12

60:6

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search 55:9,10,11

55:21 63:18

332:21

searches 63:2

searching 62:5

seasonal 49:13

69:11 74:21

131:14 164:11,15

164:16 326:14,14

326:19 327:2

333:14

second 26:8,17,20

27:3,5 38:6 44:6

45:5 46:22 73:10

88:8 90:17 92:22

103:20 104:3,15

146:2 147:11

148:7 160:21,22

161:11 190:13

207:3 237:18

267:8 268:1 284:6

284:9 289:9 294:3

295:5 317:13

365:3 367:15

384:14 388:15

secondary 28:10

219:4 236:1

385:19

secondly 163:15

seconds 66:22

72:16 85:15 93:20

99:20

section 109:3 112:5

112:18 114:14

115:21 120:3,11

132:12,13,15

139:11 140:17

157:1,14 158:10

159:9 163:15

176:19 180:14

188:7 210:22

225:14 226:20,20

235:16 236:12,13

240:3 241:11

249:13 252:1,11

266:8,9,16 267:8

271:20 306:1

312:19 324:11

329:7 335:19

345:8 350:14

351:3,7 361:18,19

361:20 371:18

378:2,21 380:11

380:12 384:10

385:8,10 387:22

388:1 409:16

sections 40:18

108:13 172:13

176:22 211:21

252:3 253:1 266:1

266:3,6,10 345:3

350:2 362:5

377:15 378:7

380:20 382:16

388:6 410:6,7

424:14

see 10:9 14:10 23:2

23:9 25:14 29:3

30:11 35:21 39:8

43:8 46:5 47:1

49:11,19 50:21

51:9 52:15 54:6

54:11,13,15,17

55:9 56:18,22

57:4,22 58:2,16

58:18 63:10 64:10

67:10 75:5 78:17

94:16,19 101:7,12

105:1 113:14

124:4,5,9 129:13

131:1 135:5

138:22 139:1,11

152:15,16,17

155:16 160:1

164:4 167:18

171:19 178:11,18

179:14 180:14

192:7,16 194:19

195:4,6,18 199:17

201:17 209:5

211:18 214:5,8,12

214:19 219:18

222:20 226:9

232:18 234:2

253:13 254:22

256:21 280:2

287:5 295:14

296:11 312:6

316:16 318:20

319:20 320:18

323:20 325:21

326:18 329:16

330:11 337:11

340:20 342:14

351:8 354:7 363:1

363:5 379:16

385:4 387:3

393:14 403:15

412:5 422:19

425:8

seeing 46:17 48:13

78:1,2 253:3

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seek 24:11

seen 77:9,20 87:2

108:13 139:7

142:19 172:1

179:13 240:7

258:9 294:10

325:5 329:14

338:6

sees 56:18 97:1

255:12

select 58:4

selected 84:15

246:5

selection 373:13

selectively 80:18

selectivity 36:14

self 359:21

self-contained

381:10

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send 425:17,19

426:22 427:9

sends 10:21 282:22

senior 241:2

sense 35:10 107:15

111:3 136:18

159:15 188:17

240:8 252:4

262:21 328:3

332:13 352:22

380:13 387:18

395:20 402:17

411:13

sensing 177:10

sensitive 50:2,5,19

51:2,7 169:15,21

173:19 179:11,15

183:15,15 194:17

195:3,7 201:13,16

201:18,19 202:5

219:14 364:7

sensitivity 169:19

174:2,17 286:3

349:4,9 361:9

368:8,12,18

sent 60:19

sentence 199:11

291:17 327:11,15

327:18 336:12

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359:1 360:8

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378:7 399:2

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separated 143:10

separately 230:14

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separating 301:6

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separation 300:7

335:14 402:14

separations 300:9

September 26:9

27:10 71:4 75:18

sequence 157:11

sequestration

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sequitur 338:2

series 20:21 227:9

399:7 414:12

serious 249:20

seriously 139:19

serve 196:13

281:17 366:18

388:20,22 395:13

serves 389:2 391:5

400:15

service 62:6,7

serving 279:16

SES 228:16 365:13

373:13

session 102:14

298:11

sessions 9:5

set 28:3,7,9 29:12

33:1 90:19 91:1,4

99:4 115:2 120:21

121:1 189:19

227:8 248:12

264:1 294:6

354:18 400:16

sets 29:15 116:8

119:2,10 120:18

407:4

setting 19:10 24:8

111:17 116:14

189:3 263:18

340:1 394:16

424:9,18 425:1

settings 114:5

357:4

seven 332:7

seven-hour 186:5,6

severity 47:6 297:9

297:17 302:7

303:1 333:11

335:2 363:1,18

sex 365:12

Shadwick 70:5

shake 137:15

shaking 357:11

shape 112:20

332:10 360:3

Shapiro 70:6

sharp 180:16

sharpen 388:13

sharper 212:13

Shenandoah

138:11 139:8

shift 82:22 86:8

198:3 337:20

shifting 337:17

shoot 196:16

Shore's 286:10

short 8:13 32:20

33:3 39:10 41:22

58:9 61:21 115:19

168:11 198:13,20

206:14 257:3

274:1 321:13

322:8 329:7,16

347:7 350:15

386:4 387:12

395:20 401:21

405:10,16 423:16

shorten 176:16

307:14 382:19

408:3 411:6

shortened 196:13

413:3

shorter 348:13

391:1 408:18

423:1

shortest 258:8

shortly 25:22 91:5

short-shrifted

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short-term 6:16

42:3 46:7 47:16

48:2 218:21 260:2

282:12 293:8,15

295:15 316:17

321:11,15,22

324:3,4 326:20

329:5 331:2

short-term/long-...

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shot 65:5

show 21:12 31:16

54:1 63:5 91:5

98:5 131:22 133:8

137:8 149:13

154:9 174:6,6,7

201:11 248:5

251:6 260:17

262:10 267:12,16

269:2,14 294:22

311:10 330:3

332:15 335:8

337:8 414:9

showed 40:4 71:19

98:14 190:14

199:8 242:15

245:9 246:4,8,20

268:18 337:7

showing 113:20

145:17 186:10

214:16 242:13

247:4 248:21

295:15 350:17

418:8

shown 20:9 83:17

89:8 130:13 145:6

153:13 174:18

284:19,22 294:14

294:15 346:20

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shows 26:6 41:7

71:3 77:11 99:10

99:16 164:21

240:18 241:20

269:20 285:8

295:1 327:18

371:4 418:12

Shprentz 102:8

side 151:13 211:19

308:15 314:13

330:12,12 412:2

sidebar 234:15

sight 66:5

signal 96:21 98:10

signaling 172:8

significance 103:19

175:14

significant 34:22

81:4 83:10 87:3

88:10 95:13

103:13,17 107:10

116:3 216:15

253:18 305:17

315:6,9 333:10

336:21 338:12

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silly 112:14 150:22

similar 62:9 98:16

106:6 143:9 196:1

219:6 225:1

234:21 283:13

314:16 322:8

409:11

Similarly 184:1

223:7

simmering 188:9

simple 261:9

simplified 384:2,3

simplistic 172:16

simply 36:21

117:20 173:19

300:14,20 368:1

392:12

simulate 147:2

150:3

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simulation 90:13

simulations 44:2

45:4

simultaneously

62:11 272:15

single 25:15 122:17

123:6,8,18,20,20

124:8 172:3

240:19 275:20

295:11 325:3

350:5

single-day 323:13

323:15 384:11

single-spaced 16:4

singling 251:19

sink 108:9

Sitch 201:2

site 68:19 70:11,13

70:17 71:22 77:22

96:7,12,16 99:11

100:3,6 101:1

137:11 138:15

141:15 142:6

149:21 150:2

187:10 197:10

217:13,19 218:3

sites 69:21 71:14

72:4,10,18 74:6,7

78:4,8 98:12,14

132:17 138:7,8,10

139:10 140:18,21

141:3,14,21 142:8

143:6 146:19,21

149:22 150:17

151:10,11 152:16

164:12,13 165:1,2

situation 194:10

234:21 269:13

349:3 350:22

situations 242:8

six 47:22 86:18
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size 69:14 103:18

263:8 295:8

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sizes 292:10 300:2

skewed 140:19

skimmed 296:15

Skip 96:14

Slagle 303:5 308:16

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Slagley 303:22

304:6

slide 25:16 38:19

39:2,6 40:4 41:18

42:2,6,12 43:16

46:5,22 47:13,17

48:9,20 49:7,8

51:10,11 95:17

96:14 97:9,18

98:21 99:14

190:14

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53:1 79:4 89:4

94:17 95:2 100:16

100:18 101:5,14

slightly 99:5

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slip 55:17

sloppy 314:4

slow 46:21

sluggishness 179:2

small 83:1,7,9

88:10 110:18

113:18 114:18

232:6 253:19

263:13 292:8

294:7,17 297:18

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smaller 260:20

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smelting 162:13

Smog 143:19

smoke 135:10

smokers 363:4

smooth 288:18

289:3 426:21

smoothed 137:9

smoothing 76:3

220:1,3

smooths 220:8

snapshot 49:7

Society 83:6 176:8

socioeconomic

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372:20,22

sold 321:12

solubility 238:10

solution 279:21

solve 230:19 282:2

307:14

somebody 171:18

278:3 297:12

370:10 390:8

404:14 406:8

426:17

somewhat 33:18

116:4 170:4,6

176:22 225:5

233:17,19 266:13

271:10 280:12

388:16

Sona 219:11

Soo 220:22

soon 59:14 134:3

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sophisticated 254:4

268:12 334:18

sore 204:18

sorry 26:20 95:1

100:13 123:13

189:15 224:9

234:1 266:4

301:17 342:19

sort 17:7 21:13

22:7 106:2 107:22

108:7,18,19,19

109:1,8,12,15

110:19 111:11

112:22 113:16

115:16 117:8

120:18,22 126:10

131:10 136:8

163:7,11,12 164:1

164:1 168:17

174:22 188:9

189:3,6 190:11

191:6,7 194:7

211:2,7,9,16

212:21 213:3,11

213:18,21 214:1,3

214:6,17,21,22

232:16 233:2,20

250:17 252:10,16

252:20 263:20

281:14 310:5

312:19,20 338:16

343:20,22 344:5

344:18 345:7,9,21

346:3,18 347:5

353:17 354:17

357:9 360:15,20

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381:19 387:18

388:6,9,13 389:3

392:7,18 396:15

401:3 403:22

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sorts 235:7 302:19

302:19 310:8

335:1,5,21 411:12

sought 28:13 42:21

188:9

sound 142:1 306:11

sounds 73:13

Source 57:10

sources 92:18

138:15 147:22

150:10 153:7

219:7 293:13

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159:22 192:8

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310:22 317:7

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weekend 143:10

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107 4:19

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110 118:14

114 4:21

116 4:22

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176 5:14

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182 5:15

187 69:7

19 1:9 46:5 71:10

1964 105:6

1970 300:15

1977 407:2

198 5:17,18

1982 407:2

1985 241:15

199 5:19

1996 246:2 299:8

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1997 96:6

1998 303:22 304:2

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2

2 4:17 30:18 41:6

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20th 204:17,19

20-page 400:7

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20-some 283:15

20-30 402:1

200 244:22 245:1

2000 207:12

2001 77:10

2002 96:8

2003 199:2

2004 235:2

2006 31:19 34:9

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2006-to-2008 71:2

2007 70:16 71:4,11

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2008 27:17,20 28:2

28:2 29:22 33:1,6

33:12,15 34:10

45:5 70:16 71:5

71:10,10 80:14

90:2

2009 303:5,22

2010 28:4 81:2

98:13 219:10

2011 1:9 28:14

41:21 81:17 315:8

394:3

2012 27:7

2013 27:6,7,9,10,19

2014 27:11 154:8

207:7

203 5:22

21 47:13

21st 207:9 208:3

210 6:2,4

211 1:12

215 6:5

218 6:6

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221 6:8

229 7:5

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3 7:14 42:18 99:1

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3rd 427:14,15

3,000-4,000 56:12

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30 66:22 69:6 76:2

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306 6:22

319 7:2,4

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52 3:18

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58 220:16

59 311:11

6

6 6:9 39:2 45:11

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6.2 309:8

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86:22 127:20

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303:7,17 315:3,7

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60-to-70-ppb 72:2

61 3:19

62 72:7

630 141:16 142:1

6300 137:4

64 106:1,5

65 69:1 72:3,6 97:4

66 3:21

67 3:22 90:8 303:4

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7 6:17 28:11 46:4

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72 79:20

73 3:24

75 150:16

78 4:4

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8 3:2 7:2 40:4 46:19

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9 7:9 48:8 49:6,15

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9.3 189:6

9.6 177:9

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90 73:19 298:12,13

95 243:11

95th 139:14 150:15

96 336:22

98th 150:16

99 4:13
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

486

Ozone Review Panel

US EPA Clean Air Advisory Committee

05-19-11

Chapel Hill, NC