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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 + + + + +

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 OZONE REVIEW PANEL

 + + + + +

 PUBLIC MEETING

 + + + + +

 MONDAY, JANUARY 9, 2012

 + + + + +

 The meeting convened in Salon ABC

of the Marriott at Research Triangle Park,

4700 Guardian Drive, Durham, North Carolina,

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

presiding.

CASAC MEMBERS PRESENT:

JONATHAN M. SAMET, Chair

GEORGE A. ALLEN

ANA DIEZ-ROUX

H. CHRISTOPHER FREY

ARMISTEAD (TED) RUSSELL

HELEN SUH

KATHLEEN WEATHERS
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PANEL MEMBERS PRESENT:

MICHELLE BELL

JOSEPH D. BRAIN

DAVID CHOCK

WILLIAM MICHAEL FOSTER

JUDITH GRAHAM

DAVID GRANTZ

JACK HARKEMA

DANIEL JACOB

STEVEN KLEEBERGER

FREDERICK J. MILLER

HOWARD NEUFELD

JAMES ULTMAN

SVERRE VEDAL

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF

PRESENT:

AARON YEOW, Designated Federal Officer

VANESSA VU, Director, SAB Staff Office

JAMES BROWN, ORD/NCEA

BRYAN HUBBELL, OAQPS

SCOTT JENKINS, OAQPS

KAREN MARTIN, OAQPS

TRAVIS SMITH, OAQPS

JOHN J. VANDENBERG, ORD/NCEA

LYDIA WEGMAN, OAQPS

KAREN WESSON, OAQPS

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

 Page

Convene Meeting

 by Aaron Yeow, DFO 6

Welcome

 by Dr. Vanessa Vu 8

Introductions 11

Review of Agenda

 by Dr. Jonathan Samet 14

EPA Presentation on Revisions to the

Draft Ozone Integrated Science Assessment 16

 Dr. John Vandenberg 

 Dr. James Brown 

Update on the Risk and Exposure

Assessment and the Policy Assessment 40

 Ms. Lydia Wegman 

 Karen Wesson 

 Dr. Bryan Hubbell

 Dr. Scott Jenkins 

 Dr. Karen Martin

Public Comments 

 George Wolff

 Air Improvement Resources, Inc. 89

 G. Bruce Copley

 ExxonMobil Biomedical Sciences, Inc. 94

 Neeraja Erraguntla

 Texas Commission on

 Environmental Quality 104

 Roger McClellan

 Toxicology and Human Health

 Risk Analysis 110

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 C-O-N-T-E-N-T-S (Cont'd)

 Page

 Deborah Shprentz

 American Lung Association 118

 William McDonnell

 William F. McDonnell Consulting 123

 Christopher Emery

 ENVIRON International Corporation 140

 Richard Smith

 University of North Carolina 147

 Mark Nicolich

 COGIMET 154

 Nicole Downey

 Earth System Sciences, LLC 158

 Julie Goodman

 Gradient 167

 Sonya Sax

 Gradient 170

 Doug Blewitt

 Air Quality Resource Management 173

 John Jansen

 Southern Company 179

 Samuel Oltmans

 University of Colorado Boulder 186

 Allen Lefohn

 A.S.L. & Associates 193

 Milan Hazucha

 University of North Carolina

 Chapel Hill 200

 Discussion of EPA Charge Questions 208

Page 5

 C-O-N-T-E-N-T-S (Cont'd)

 Page

Atmospheric Chemistry and Ambient

Concentrations (Chapter 3) 215

Exposure to Ambient Ozone

(Chapter 4) 258

Dosimetry and Mode of Action

(Chapter 5) 270

Integrated Health Effects - Short-Term

and Long-Term (Chapters 6 & 7) 305

At Risk Populations

(Chapter 8) 362

Ozone Effects on Vegetation and Ecosystems

(Chapter 9) 387

Role of Tropospheric Ozone in Climate

Change (Chapter 10) 402

Preface, Preamble, Executive Summary

(Chapter 1) 409

and Integrative Overview

(Chapter 2) 418

Adjournment 459
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:30 a.m.

3 MR. YEOW: Good morning. I'm

4 Aaron Yeow, the Designated Federal Officer for

5 this public meeting of the Clean Air

6 Scientific Advisory Committee Ozone Review

7 Panel.

8 I'd like to convene and open this

9 public meeting with a short statement. The

10 panel is meeting today and tomorrow to conduct

11 a peer review of EPA's second draft integrated

12 science assessment for ozone.

13 CASAC is a federal advisory

14 committee and by EPA policy its meetings and

15 deliberations are held as public meetings that

16 meet the requirements of the Federal Advisory

17 Committee Act, also known as FACA.

18 Through the charter CASAC, the

19 panel is empowered by law to provide advice to

20 the administrator. Consistent with the

21 requirements of FACA and with EPA policy, the

22 deliberations of the panel are conducted in

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1 public at meetings for which advance public

2 notice is given.

3 The discussions and substantive

4 deliberations of the panel, its interactions

5 with the public and the agency are conducted

6 in sessions where I, as the DFO, am present to

7 ensure that the requirements of FACA are met. 

8 This includes the requirements for

9 open meetings, for maintaining records of

10 deliberations of the panel, making available

11 to the public summaries of meetings and

12 providing opportunities for public comment.

13 We have received several written

14 public comments which are available on our

15 website, and we have 16 registered public

16 speakers for today. Copies of their

17 presentations and/or their oral statements are

18 also posted on our website.

19 Minutes of this meeting are being

20 taken to summarize discussions and action

21 items in accordance with requirements under

22 FACA. These minutes will be certified by the

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1 Chair once completed.

2 I want to remind all in attendance

3 of the status of this panel's compliance with

4 federal ethics laws. The SAB Staff Office has

5 determined that there are no issues with

6 conflict of interest or appearance of a lack

7 of impartiality for any of the advisory panel

8 members participating in this review.

9 I also want to note that Dr. John

10 Bailar will be on the phone and Dr. Ted

11 Russell will be a little late this morning.

12 I would now like to turn the

13 meeting over to Dr. Vanessa Vu, Director of

14 the SAB Staff Office, and then over to Dr. Jon

15 Samet, Chair of the CASAC.

16 DR. VU: Thank you, Aaron. Good

17 morning, everyone. I'm Vanessa Vu. I'm the

18 Director of EPA's Science Advisory Board. I'd

19 like to welcome everybody to the meeting of

20 the Clean Air Scientific Advisory Committee

21 Ozone Review Panel.

22 The purpose of this meeting is for

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1 the panel to discuss and deliberate the, to

2 review comments on the agency's integrated

3 science assessment on ozone and other

4 photochemical oxidants.

5 First, I would like to Dr. Jon

6 Samet, members of the Clean Air Scientific

7 Advisory Committee and invited members to this 

8 ozone panel for your time and your public

9 service to EPA in rendering your advice to

10 EPA.

11 I'd like to take this opportunity

12 and publicly thank Dr. Joe Brain, who serve on

13 the charter CASAC. We very much appreciate

14 your valuable service to the CASAC and of

15 course to EPA.

16 And a special welcome to Dr. Ana

17 Diez-Roux, who's joining us as a new member of

18 the charter CASAC, appreciate that. Thank

19 you, Ana, welcome.

20 This morning you will hear

21 presentations from the Agency. Up front at

22 the table here, we'd like to thank John
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1 Vandenberg and Dr. Jim Brown. Both of you

2 will be talking about the Agency's document,

3 the ISA.

4 Later on you will also be joined

5 by representatives from the Office of Air

6 Quality and Planning Standards, who will give

7 a talk about the update where we are on this

8 round of review for ozone. That led by Ms.

9 Lydia Wegman, Dr. Bryan Hubbell and Dr. Karen

10 Martin from OAQPS, so thank you all for being

11 here today.

12 As Aaron has indicated, we have

13 received public comments. As you know, public

14 input is a very critical input for the

15 advisory process, and I ask that the members

16 of this panel to consider the public comments.

17 I'd like to thank the public

18 commenters who submit written comments as well

19 as the speakers who will be here today to give

20 an oral presentation in person or on the

21 phone.

22 With that I'd like to thank my

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1 staff, who make this meeting possible. As you

2 know, Holly Stallworth is the DFO of the CASAC

3 and she's unable to be here, but we want to

4 let you know that Aaron Yeow, thank Aaron for

5 especially stepping in to take over. And I

6 appreciate Aaron, who provided excellent

7 technical support to the group.

8 With that I'd like to turn the

9 meeting over to Dr. Jon Samet.

10 DR. SAMET: Okay, thank you,

11 Vanessa and Aaron, and good morning to

12 everyone.

13 Just I think what we'll do is go

14 around the room and ask the panel members to

15 introduce themselves and then we'll come back

16 and talk about the agenda. Jon Samet from the

17 University of Southern California, a pulmonary

18 physician, epidemiologist. Vanessa you've

19 heard from.

20 Judy?

21 DR. GRAHAM: Judy Graham, I'm

22 retired, my background, I'm a toxicologist. 

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1 I've spent some time in exposure and risk

2 assessment.

3 DR. MILLER: Fred Miller,

4 independent consultant, statistics,

5 toxicology, dosimetry.

6 DR. BRAIN: I'm Joe Brain. I'm at

7 the Harvard School of Public Health. I'm a

8 lung biologist.

9 DR. HARKEMA: I'm Jack Harkema

10 from Michigan State University. I'm an

11 inhalation toxicologist and pathologist.

12 DR. VEDAL: I'm Sverre Vedal,

13 University of Washington. I'm a pulmonary

14 physician and an epidemiologist.

15 DR. BELL: I'm Michelle Bell at

16 Yale University, and I work primarily in air

17 pollution epidemiology.

18 DR. CHOCK: I'm David Chock,

19 independent consultant at University of

20 Michigan Environmental Science and

21 Sustainability.

22 DR. JACOB: Daniel Jacob, Harvard

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1 Atmospheric Chemistry.

2 DR. ULTMAN: Jim Ultman, Penn

3 State University, dosimetry.

4 DR. FOSTER: Mike Foster, Duke

5 University Medical Center, environmental

6 health scientist.

7 DR. KLEEBERGER: Steve Kleeberger,

8 NIEHS, environmental pulmonary geneticist.

9 DR. DIEZ-ROUX: Ana Diez-Roux,

10 University of Michigan. I'm an

11 epidemiologist.

12 DR. SUH: Helen Suh, NORC at the

13 University of Chicago. I do exposure science

14 and environmental epi.

15 DR. NEUFELD: Howard Neufeld,

16 Appalachian State University, a plant

17 physiologist.

18 DR. GRANTZ: David Grantz,

19 University of California at Riverside, also a

20 plant physiologist.

21 DR. WEATHERS: Kathleen Weathers,

22 Cary Institute of Ecosystem Studies. I'm a
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1 biogeochemist.

2 MR. ALLEN: George Allen from

3 NESCAUM in Boston. I focus on measurement

4 methods and exposure assessment.

5 DR. FREY: Chris Frey at North

6 Carolina State University. I'm a

7 environmental engineer.

8 MR. YEOW: Just wanted to give a

9 quick reminder for the panel members to use

10 the microphone because there are people on the

11 phone. And then also a reminder for those on

12 the phone to mute your lines when you're not

13 speaking. Thank you.

14 DR. SAMET: And let's see, John

15 Bailar, if you're on the phone could you

16 introduce yourself, please? Not yet, okay. 

17 So let's just spend a moment

18 looking at the agenda. We have a full day

19 beginning with hearing from the NCEA team led

20 by John Vandenberg, the update from the OAQPS

21 group led by Lydia Wegman.

22 The public comment period, I

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1 believe that we have 16 commenters signed up

2 as mentioned. Going to go back and have a

3 brief committee discussion of the charge

4 question and see if there are other key issues

5 that the panel feel we should discuss while

6 here.

7 And then we're going to move on to

8 a discussion of our charge questions, and we

9 already have a great deal of work done by the

10 committee members which I appreciate.

11 I'm expecting a lot of work out of

12 the committee tonight even though you may have

13 other plans, and tomorrow we'll come back and

14 have as a key objective the discussion of key

15 points that will go into the draft letter.

16 One addition to the schedule

17 coming out of discussions at the SAB with

18 Vanessa is the 8:30 a.m. tomorrow slot for the

19 opportunity to make brief clarifying remarks

20 by members of the public.

21 These might be, for example,

22 points of clarification or additional

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1 information. This is not an opportunity to

2 repeat what would be said during today's

3 public comment session. So this is something

4 new in our agenda to provide additional

5 opportunity for public input. And we adjourn

6 tomorrow at 11:30. So that's what is

7 anticipated for our schedule.

8 (Off microphone comment.)

9 Aaron offered to remind me that

10 tomorrow should any member of the public want

11 to make a comment, please identify yourself to

12 Aaron, and these comments will be limited to

13 one minute should you choose to make a point. 

14 So this is an opportunity to make brief,

15 additional points.

16 Okay, so with that review and a

17 busy day ahead, why don't we get started? 

18 John, we turn to you.

19 DR. VANDENBERG: Thank you very

20 much, Dr. Samet. I'd like to extend my

21 appreciation much as Vanessa did to the Chair

22 of the CASAC as well as to the committee

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1 members. It's a significant effort that

2 you've put into the review and your time today

3 as well as subsequently. It's very much

4 appreciated by all of us.

5 I'd also like to extend my

6 appreciation to the public for their comments

7 and for the many participants we have in the

8 room here today.

9 I'm the Director of the National

10 Center for Environmental Assessments RTP

11 Division, and my staff is here that have been

12 involved in the drafting of this document and

13 we very much appreciate your time and comments

14 as we move to finish this document.

15 I'm joined here this morning at

16 the table by Dr. Jim Brown. Dr. Brown will be

17 providing much of the overview of the changes

18 that we've made to the assessment.

19 Our timeline is, we finished the

20 first draft of this back in March of last

21 year. We had a meeting by CASAC in May and

22 the second draft came out in September, which
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1 is what we're reviewing today.

2 Our target is to finish the ISA

3 sometime in the February or March time frame

4 which obviously is very quick but, you know,

5 we're very optimistic that we can, and we've

6 got a very strong team working on this that we

7 can move forward given the comments that we'll

8 receive today and tomorrow as well as the

9 written review from CASAC subsequently.

10 As I mentioned, the team that we

11 have is, many of these individuals are present

12 here in the room. In addition, we have a

13 number of individuals who have served as

14 external authors to us that you can see on the

15 list there as well.

16 Together I think this represents a

17 significant effort by the agency to make sure

18 that we're identifying and evaluating and

19 communicating the state of the science for

20 ozone for the benefit ultimately of the

21 administrators' decisions to support the

22 review of the next Ambient Air Quality

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1 Standard.

2 Just in very brief summary of some

3 of the major revisions we made in response to

4 the comments we received on the first draft is 

5 we have continued to view this as a flexible

6 process where we benefit from the comments.

7 And clearly there was a lot of

8 discussion at the last meeting about the

9 executive summary, so the executive summary is

10 now identified as Chapter 1. And you might

11 wonder why, and part of that is just a

12 renumbering issue. We can again benefit from

13 comments about whether that's an effective way

14 to communicate the major findings of the

15 assessment which would be used by a number of

16 different audiences.

17 What was in Chapter 1 before, the

18 information there has essentially been parsed

19 out to other parts. We're moving towards

20 having a preamble that describes the process

21 of the Integrated Science Assessment

22 development and the causality framework and

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1 this doesn't change very much. And so rather

2 than having it be Chapter 1, we're moving it

3 to be a preamble that will be consistently

4 applied across the different ISAs.

5 Then turning more specifically to

6 the ozone review, we've created a preface

7 here. So what we have is a review of

8 basically the background, the historical

9 development of the ISAs over time, and again

10 that information doesn't change very much so

11 it seems to be appropriate as a preface.

12 And then other material in terms

13 of the introductory material specific to this

14 ISA has been moved into Chapter 2, which is

15 really focused on the integration of the

16 science. Trying to bring to bear the

17 framework that we have developed, the science

18 that we've reviewed and to draw those

19 causality conclusions and to communicate that

20 as what is now Chapter 2.

21 Looking to other more significant

22 changes, we've done quite a bit of background

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1 modeling on ozone and much of this work has

2 been developed just over the course of this

3 summer, as I'm sure we'll hear comments about

4 that. We refer to that both in the body of

5 the document as well as in the appendices, and

6 we'll be largely focusing only on what's in

7 the body of the document.

8 Some of that modeling still is

9 evolving, and I think at this point we're

10 probably only going to depend upon the

11 published modeling that was put forward by the

12 scientific authors.

13 Chapter 8 is dealing in the past,

14 susceptibility, vulnerability, at risk. 

15 There's a variety of terms here and we

16 continue to see even in the comments received

17 up to this point about the terminologies that

18 we're using here.

19 And in this iteration we have

20 focused on the term "at risk." And again we

21 welcome comments on that as we receive your

22 review comments.
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1 At this point I'd like to turn to

2 Jim Brown, and Jim's going to be reviewing the

3 more detailed information as well as the

4 charge questions.

5 DR. BROWN: Good morning. John

6 just went through some of the major changes in

7 the document. I'm going to be going very

8 quickly through our charge questions and

9 highlighting some of the changes that we've

10 made as well.

11 Starting with this, this is the

12 chapters that we now have in our document. 

13 We've added a preamble and a preface as John

14 just said.

15 We've added a new Chapter 1

16 because there were many comments received

17 saying that we needed an executive summary to

18 communicate some of our findings to the public

19 and more of a lay audience as compared to what

20 is Chapter 2, our integrative summary, which

21 can be very detailed with all the science

22 coming in from all these subsequent chapters.

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1 So I'm going to go through the

2 charge questions very briefly. I've

3 underlined some key parts of them just again

4 to highlight some of the changes for you that

5 were incorporated into the document.

6 This is Charge Question 1. It's

7 for the preamble, preface, Chapters 1 and

8 Chapter 2. Again, there's an executive

9 summary that's been prepared and now put in

10 place in Chapter 1.

11 Chapter 1, our original Chapter 1

12 has been moved into the preamble and the

13 preface and went in to Chapter 2. We tried to

14 streamline Chapter 2 also to make it more

15 integrated as John mentioned. And you can see

16 the other underlined things such as the

17 legislative history and stuff which has now

18 been moved as well.

19 These are our causal

20 determinations for the health. I have these

21 here not to highlight a change but just to let

22 you know that we did not make a change to

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1 these causal determinations for the health. 

2 I put that in there because when I get to the

3 eco you'll notice a small change in the causal

4 determinations there.

5 This is a new figure that we've

6 added into Chapter 2. We also have a pyramid

7 of effects in Chapter 1, but this one is a

8 little more detailed. And we tried to

9 highlight some of the evidence from the

10 different disciplines that went into our

11 conclusions that there are effects such as

12 respiratory mortality.

13 In this figure, again which is new

14 in Chapter 2, the purple indicates findings

15 that were coming in from epidemiology, green

16 is the toxicological findings and blue is some

17 of the health effects findings. And we're

18 working on a table that summarizes all of

19 those studies as well to support where these

20 conclusions are derived from.

21 This is a new figure that's also

22 now in Chapter 2 and in Chapter 9. It's meant

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1 to help lead people through the ecological

2 effects of ozone and it refers to other

3 figures and sections within the document to

4 help navigate the reader through those

5 sections.

6 Moving on to the next charge

7 question, Chapter 3. Sections 3.4 and

8 Sections 3.9 were updated and expanded and

9 Section 3.6 was also revised. A lot of the

10 discussion in that chapter and a lot of the

11 interest to the public is in background ozone

12 or what we have historically referred to as

13 Policy Relevant Background.

14 Referring to the little schematic

15 here, what is background? Well, it's

16 something that we can't directly observe but

17 something that we can only model, and it's the

18 concentrations of ozone that would exist from

19 long range transport, from outside natural

20 influences, stratospheric ozone intrusion and

21 sources such as lightning, but no manmade

22 emissions.
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1 And at the bottom you can see that

2 there are different ways that you could define

3 this background ozone as well, such as in a

4 natural background where you might turn off

5 all of the manmade emissions in the entire

6 world.

7 North American background, where

8 you turn off the emissions theoretically in

9 the United States, Canada and Mexico, or the

10 U.S.-only background where you still have

11 manmade emissions in the rest of the world but

12 not within the United States.

13 I'm sure that we'll have a lot of

14 comments and discussion on this as the day

15 progresses.

16 So if I move through this too

17 quickly that's for the sake of time, and

18 please, panel, you can interrupt me at any

19 time.

20 Okay, Charge Question 3 is

21 focusing on Chapter 4, our exposure chapter. 

22 And we've added some clarifying discussion on

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1 the relevance of central site monitoring for

2 interpretation of the epidemiological studies. 

3 We've revised the summary sections

4 to be more concise and focused. We've

5 prepared tables, and that's not just in this

6 chapter but throughout the other chapters. 

7 We've tried to put more tables in and more

8 figures such as the ones that I've already

9 showed you to help summarize some of our

10 findings.

11 We've also added discussion on

12 averting behavior which is discussed on the

13 subsequent slide. So what is averting

14 behavior? Well, this is when people hear air

15 quality alerts and they change their behavior

16 to avoid exposure to the ambient ozone and

17 does that affect our interpretation of

18 studies.

19 There is a little bit of

20 information that is available that says that

21 some groups such as asthmatics, children and

22 adults, or individuals that experience

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1 respiratory symptoms may change their behavior

2 but that it's not pronounced in the general

3 population. We all have to go to work still,

4 we commute, and so we tend to ignore those

5 advisories.

6 This is preliminary though, the

7 information that we have. It's only available

8 from mainly one location, Los Angeles. I've

9 moved over to the second bullet in the right

10 hand column.

11 Although we've included this we

12 did want to note that it's new data. There's

13 not a lot of data right now. It's mainly

14 again focused in one area, Los Angeles, for a

15 limited number of years when we had the higher

16 one-hour standard of .12 ppm in place, and

17 more evidence is needed as to whether these

18 effects might influence epidemiological

19 findings at our current ambient levels.

20 Moving on to our fourth charge

21 question, Chapter 5, the dosimetry and mode of

22 action. This chapter's been very much

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1 reorganized throughout. They've tried to

2 integrate the dosimetry and have it lead more

3 into the mode of action, which has also now

4 been more linked to Chapter 6 and 7 where we

5 discuss the health effects.

6 There was a criticism that there

7 was too much health effects evidence

8 previously presented in Chapter 5, and that

9 has been moved and it's more focused just on

10 again, the mechanisms of action.

11 Here's a new figure that was

12 included in that chapter, talking about the

13 uptake of ozone which is our dosimetry

14 component, some of the reaction of the

15 secondary oxidation products. And then we

16 have a fuzzy line there where we start moving

17 into the mode of action.

18 Yes?

19 MR. YEOW: Sorry to interrupt,

20 James. Can you pull the microphone closer and

21 speak louder into it?

22 DR. BROWN: Sorry, I was trying
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1 not to talk too loud because I heard such an

2 echo earlier.

3 MR. YEOW: Thanks.

4 DR. BROWN: Our Charge Question 5

5 focuses on both of the health chapters,

6 Chapters 6 and 7. That's the short-term and

7 the long-term effects of ozone, respectively. 

8 These chapters contain toxicological

9 controlled human exposure studies and

10 epidemiological evidence for effects of ozone.

11 We've added a lot of new

12 references. Well, they're not new references. 

13 They're old references that we've tried to

14 make sure to pull in from some of our old

15 documents to really show the depth of

16 information that is available not just for the

17 controlled human exposure studies but for the

18 toxicology and the epidemiology as well. And

19 we've tried to focus more on the integration

20 with that old evidence that we had in the last

21 document.

22 We've also added a number of

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1 tables and figures to hopefully better convey

2 the evidence to the readers. This is an

3 example of one of the figures that was

4 included in this. This is from the controlled

5 human exposure studies.

6 There's been a criticism as to

7 there not being much evidence down below 80

8 ppb ozone, and this figure was put in to try

9 to illustrate the extent of the evidence, the

10 number of studies that are available below 80

11 ppb of ozone.

12 On that figure, unless otherwise

13 indicated the data is from chamber studies to

14 a square wave or constant concentration of

15 ozone. Some of the points have an M next to

16 them. That's for a face mask, so the subjects

17 were exposed with a face mask.

18 Other subjects have a T next to

19 them. That's studies where people were

20 exposed to a variable concentration or a

21 triangular concentration profile which you'll

22 hear other people talking about, some of the

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1 public commenters I believe today. And that's

2 a new figure, 6.1b.

3 Our next charge question, Charge

4 Question 6, this is the Chapter 8, the at-risk

5 populations or susceptible populations

6 depending on what your preference is.

7 We've tried to focus that now on

8 the terms that were recommended last time,

9 those being mainly intrinsic and extrinsic

10 factors that affect the susceptibility of an

11 individual as well as increased dose due to

12 activity outside which may cause greater

13 exposure.

14 Charge Question 7, moving over to

15 the ecological effects. This has been

16 consolidated into fewer but more integrated

17 sections.

18 I mentioned earlier that I put up

19 the causal determination slide for the health

20 effects in humans because we didn't make

21 changes there, but I wanted to highlight that

22 we did make changes within this chapter. 

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1 Specifically, the second and the fourth causal

2 determinations there that are grayed out have

3 been integrated into other causal

4 determinations.

5 Then that is what the footnotes on

6 this table are indicating. Footnote 1 are the

7 two causal determinations which have now

8 incorporated the information on the alteration

9 of vegetation reproduction, and Footnote 2 is

10 for the second causal determination, the

11 alteration of leaf gas exchange in vegetation. 

12 Those two causal determinations

13 have that information integrated in them. So

14 we didn't throw away the information, we've

15 just integrated it into some of the other

16 causal determinations as we tried to make the

17 chapter more concise.

18 And with that I would like to turn

19 over to our second set of EPA speakers unless

20 there are questions, because we've got a busy

21 day ahead of us.

22 DR. SAMET: Let's see, are there
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1 questions at this point for the team? Dan?

2 DR. JACOB: Yes. I have a

3 question about the description of background

4 ozone as you say we might be talking quite a

5 bit about this today.

6 But there are two different

7 calculations of the background ozone that are

8 shown in Chapter 3. I know there's been some

9 change since the first draft. And those two

10 calculations are done with GEOS-Chem Model,

11 and for full disclosure I'm the GEOS-Chem

12 Model scientist.

13 And the background calculation

14 described in Section 3.4 as you pointed out,

15 is the published one and the one that really

16 should be used.

17 What I'm wondering about is what

18 is the other calculation that's presently in

19 Section 3.9 doing at all in that document,

20 because we know that it's incorrect. It was

21 done with a buggy version of the model and it

22 just sows confusion.

Page 35

1 DR. VANDENBERG: Thank you for

2 that comment. And just to be clear, one of

3 the things that we'll talk about maybe when we

4 get to Chapter 3 is that type of information. 

5 Our intention at this point is to

6 not use what's in 3.9 at all because that was

7 developing even as we were developing the

8 chapter, and once we got the document

9 together, distributed it, then we realized

10 that there was some errors in the model as

11 you've just pointed out.

12 DR. JACOB: So this section is

13 going to be deleted?

14 DR. VANDENBERG: It's going to be

15 deleted, yes. Yes, it'll be deleted.

16 DR. JACOB: Thank you.

17 DR. VANDENBERG: So focusing on

18 the published papers is what our intent is. 

19 The work that was done in addition was to help

20 support subsequent analysis we found there. 

21 As you just pointed out there's some errors

22 there and so we'll just delete that.

Page 36

1 DR. JACOB: Okay.

2 DR. SAMET: John, a question for

3 you. Just on the structural issue, are you

4 seeking to have uniformity across all the

5 ISAs? In other words, you know, this

6 rearrangement, preface, prologue, monologue,

7 whatever you're doing, along with Chapter 1

8 that's a general executive summary, is this

9 the standard you're seeking and have you lined

10 up the structure of the different documents as

11 they've, the different ISAs, because we're now

12 what, four or five years into ISAs?

13 Do they all look different? And

14 frankly, I can't remember, but it seems like

15 you're continuing to have evolution of the

16 structure. So what is the goal?

17 DR. VANDENBERG: Partially, and

18 that is that the parts on the front end here,

19 the new preamble, preface, the background

20 information related to the process that we use

21 and then the historical context which is the

22 preface, and some form of an executive summary

Page 37

1 and then an integrated overview. That's what

2 we're moving towards.

3 The subsequent chapters depend

4 upon the ISA and so there is a somewhat

5 different specificity of information. So what

6 I'm saying is that I expect that in the future

7 that this will become more fixed than it has

8 been and we're going to be moving towards a

9 style of structure that will be most

10 informative and not inconsistent from one to

11 the other.

12 I think that what we've really

13 benefited from is the CASAC comments on this,

14 is to continually help us as we evolve this. 

15 But I can't remember which chapter the at-risk

16 population is but the number for that, 8, may

17 be different from lead than it is from ozone

18 just because of the preceding chapters may be

19 a little different. We may not have chapters

20 on ecosystem effects, for example, for some of

21 the other ones. So the front end, we're

22 moving towards consistency and this is a
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1 reflection, I think, of that movement towards

2 that.

3 It perhaps is awkward here now to

4 have an executive summary and then Chapter 1,

5 if you count that overview chapter, or Chapter

6 2 actually is what it is. That's the kind of

7 thing that I think we can fix.

8 What it makes unfortunately for

9 this review, is it makes it seems like it's

10 sort of still scatter-shot a little bit. I

11 anticipate that that will be much clearer in

12 the final document than it is right now.

13 And it has been I think clear to

14 us that we can do a better job in

15 communicating in the front end, and that's

16 what this is really doing is we're fixing the

17 front end.

18 DR. SAMET: Okay, good. Thanks.

19 Joe?

20 DR. BRAIN: Yes, I have a related

21 question and comment. I really like the

22 uniform format and one can see how this

Page 39

1 uniform format could be adopted to different

2 pollutants.

3 On the other hand, the preamble

4 seems like it's a single document not ozone

5 specific. And I think it's incredibly

6 valuable, so my question is, you know, do you

7 see a process to gain further input, to even

8 have peer review to publish that as a

9 freestanding document?

10 It's, you know, I see it as really

11 an important tool and wouldn't like to see it

12 only in this document. It seems to me it

13 should be, you know, published in an ATS

14 journal or somehow be more widely available

15 and perhaps even considered more carefully

16 before that.

17 What plans do you have for the

18 preamble?

19 DR. VANDENBERG: Well, I

20 appreciate that comment because I agree with

21 you, and I think it would be useful for us to

22 take that and publish it and go through, you

Page 40

1 know, that process.

2 At this point I think our plans

3 are still evolving and we welcome those

4 comments and suggestions, because I think

5 it's, I like your comment because it, I think,

6 endorses that we've done a good job of

7 characterizing that.

8 So no specific plans, but I

9 appreciate this endorsement to move forward

10 with them.

11 DR. SAMET: Okay. Welcome, Ted.

12 Is John Bailar, are you on the

13 phone? Somebody signed on. Okay, no. Okay,

14 any other just very general overarching issues

15 to bring up?

16 Okay, then let's change teams. 

17 Lydia?

18 MS. WEGMAN: Good morning, Jon,

19 and good morning to the whole panel. It's

20 very good to see all of you here and I thank

21 you as always for all the time that you take

22 in reviewing the EPA documents.

Page 41

1 We're going to go over a little

2 bit here of the structure that we're working

3 on for the risk and exposure assessment, and

4 I want to introduce before I go into the

5 presentation, the folks who are with me.

6 This is Karen Wesson, and she's

7 working on the risk and exposure assessment

8 along with Bryan Hubbell who is here to help

9 answer questions. Karen will do the part of

10 the presentation on the risk and exposure

11 assessment.

12 And then Scott Jenkins is here and

13 he'll be talking about the policy assessment

14 document, and Karen Martin is here as well. 

15 And Travis Smith has been working on the

16 secondary standard portions of both of those

17 documents, so he's here to answer any

18 questions you may have.

19 Okay, again, what I want to do

20 briefly is go over the schedule for this

21 review and then turn it to Karen to talk about

22 the structure, the analytical components and
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1 the issues that we're seeing with the risk and

2 exposure assessment at this point, and then

3 Scott will cover the same issues and structure

4 for the policy assessment.

5 We wanted to go over this with you

6 in case you had any initial comments on the

7 risk and exposure assessment and our plans for

8 it, because any early feedback we get may help

9 us in putting together the first and second

10 drafts of the risk and exposure assessment and

11 then also the policy assessment.

12 So all of you know, I believe,

13 that we are no longer proceeding with the

14 reconsideration of the March 2008 ozone

15 standard, but the fact that we did pursue it 

16 led to some delay as far as moving forward on

17 this review.

18 So you will see here a schedule

19 that shows a final standard in July of 2014,

20 not quite the five years contemplated by the

21 statute but as close as we feel we can get at

22 this point.

Page 43

1 It's shown in yellow, the meeting

2 that we're having today, and Jon's already

3 gone over the schedule for the ISA, so I'm

4 just going to go over the schedule for the

5 risk and exposure assessment.

6 What you'll see is something a

7 little different from what we've done in the

8 past, but not that different. We are linking

9 the first and second drafts of the risk and

10 exposure assessment and the policy assessment

11 documents for your review in order to try to

12 make as much progress as we can and ensure

13 that we meet the schedule that I'm showing you

14 today.

15 So you'll see in the middle block

16 that in the gray is the scope and methods plan

17 which you've already reviewed. We hope to

18 release the first draft of the risk and

19 exposure assessment in March of this year, a

20 mere two months from now.

21 And if you look at the policy

22 assessment, which is the last block on the

Page 44

1 page, you'll see we plan to release the first

2 draft of that in April. So we will be

3 releasing them back to back, and then we hope 

4 to have a meeting with you in late May or

5 early June to review the first drafts of both

6 the risk and exposure assessment and the

7 policy assessment.

8 And then we hope to release and

9 plan to release the second draft of the risk

10 and exposure assessment in November of this

11 year with the second draft of the policy

12 assessment coming a month later in December of

13 2012, and then meet with you to review both of

14 those documents in January or February of

15 2013.

16 And then we hope to have a final

17 risk and exposure assessment in April of 2013,

18 and the final policy assessment in May of 2013

19 with a proposal in October of 2013, and then

20 as I said, the final rule in July of 2014.

21 So this is the schedule that we

22 are working on and we hope that you will be

Page 45

1 able to work on it with us, and as always we

2 appreciate all your help.

3 Unless anyone has questions on

4 that I'm going to turn this over now to Karen

5 Wesson, and as I say she'll talk about the

6 risk and exposure assessment.

7 And I want to just note we really

8 welcome any comments you have on the

9 structure, the analysis we have planned and

10 the issues for both the risk and exposure and

11 policy assessment documents.

12 MS. WESSON: Thank you, Lydia. So

13 as Lydia mentioned, I'll be going over some

14 slides on what we're planning for the risk and

15 exposure assessment.

16 We have a first draft that we're

17 currently working on that will be coming to

18 you for review in March, and so this is to

19 give you a little bit of insight into what we

20 are currently working on.

21 So the first slide gives a general

22 overview of the key topic areas that we're
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1 working on. We'll have an air quality

2 characterization, and then for the primary

3 standard we will have a characterization of

4 human exposure to ozone. In addition we'll

5 have a characterization of health risk, but

6 it's clinical based and epidemiological based.

7 We'll have a discussion of the key

8 findings based on these data for the primary

9 standard. And then for the secondary standard

10 we'll have an assessment of welfare, risk and

11 exposure and then we'll have a discussion of

12 the key findings for the secondary standard.

13 So to get into a little bit more

14 detail about this we'll flip to the next

15 slide. So for the exposure assessment we plan

16 to use the Air Pollutants Exposure Model or

17 APEX.

18 We plan to include the populations

19 of general population, school age children and

20 asthmatic school age children. All of these

21 will be included in the first draft. In

22 addition, we will also add outdoor workers and

Page 47

1 elderly people for the second draft.

2 We are using five years of ambient

3 data, 2006 to 2010, and we'll be calculating

4 design values for the 2006 to 2008, and then

5 the 2008 to 2010 period.

6 So for the clinical based risk

7 assessment we are also using the APEX model

8 and we'll be using the same populations and

9 the same years of ambient data. We are

10 working currently to update the exposure

11 response function from the last review with

12 results of new clinical studies.

13 Then for the epidemiological-based

14 risk assessment we have two components, a

15 city-specific analysis and then a national

16 scale analysis that we are planning to

17 include.

18 For the city-specific analysis we

19 are planning to use the benefits mapping and

20 analysis program, or BenMAP. We are going to

21 use this to evaluate short-term ozone exposure

22 for premature mortality and morbidity.

Page 48

1 And we're pretty excited about

2 being able to use the BenMAP program. This is

3 the first time that we've used it in the risk

4 and exposure assessment though of course we've

5 used it many times in the past for benefits

6 assessments.

7 We're excited to use it because it

8 provides a systematic approach to analyze

9 risk, it also is well documented and will

10 allow others to replicate these results very

11 easily.

12 For the city-specific

13 epidemiological based risk assessment we are

14 also using the same five years of ambient

15 data, 2006 to 2010, with the same two periods

16 of rollback, 2006 to 2008, and 2008 to 2010.

17 So flipping to the next slide, for

18 the national scale analysis for the

19 epidemiological based risk assessment we are

20 using a national scale spatial surface, so we

21 want to be able to capture ozone

22 concentrations in areas that we don't have

Page 49

1 monitors.

2 And so to do this we're using a

3 fused surface of the CMAQ model and ambient

4 data. The ambient data will be for 2006 to

5 2008 with the model capturing the gradients in

6 between the monitors, and we're going to use

7 a CMAQ model from 2007.

8 So for the national scale

9 assessment we will also be using BenMAP to

10 evaluate the short-term ozone exposure looking

11 at premature mortality. And we will use this

12 data in addition to better understand the

13 representativeness of the selected cities by

14 comparing those selected cities to the other

15 major cities in the United States.

16 So for the secondary standard

17 we're going to also use a national scale air

18 quality surface of W126. This will also be a

19 fused surface of monitor data from 2006 to

20 2008, and the CMAQ model with 2007.

21 We'll be looking at ecological

22 risk and exposure and we'll be including
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1 specific case study areas for more refined

2 analysis. And then we'll also be looking at

3 ecosystem service risk assessment based on

4 ecological effects and modeling.

5 So flipping to the next slide. So

6 for the next three slides we wanted to take

7 the chance to highlight items that are new in

8 this REA that are different from the last --

9 our review of the ozone standard, and to also

10 highlight things that have changed since the

11 scope and methods plans were put out.

12 So the first bullet is a change

13 for both, it's something new and also

14 something changed from the scope of methods

15 plans. So for the REA, for the first draft,

16 we propose to look at total health effects and

17 incidents without consideration of a

18 background concentration.

19 So this means looking at ozone

20 risk down to zero without consideration of a

21 background value. So we've given a lot of

22 time and thought to the policy questions that

Page 51

1 we were trying to answer in the REA and we

2 feel that it's appropriate for us to be

3 looking at ozone risk down to zero.

4 While we believe it's important to

5 understand background concentration, we

6 believe that it would be better placed in

7 implementation and we propose to consider it

8 in the REA.

9 In addition, we understand that

10 every molecule of ozone impacts risk and so we

11 propose to look at total ozone risk without

12 parsing risk into ozone from different

13 sources.

14 So on the second bullet for the

15 risk and exposure assessments, we estimate

16 ozone concentration for meeting the current

17 standard and for also meeting alternative

18 standards and we start with the recent air

19 quality data to do this.

20 For the first draft we will

21 include an estimation of ozone concentrations

22 to meet the current standard, and in the

Page 52

1 second draft we will also include the same for

2 meeting alternative standards.

3 So for the first draft we propose

4 to use the quadratic rollback method. It's

5 the method that we've used in the last

6 reviews. For the first draft we'll be using

7 this, and it requires that you set a

8 concentration lower bounds, a bounds that you

9 cannot roll air quality values beyond.

10 And for this, for the first draft,

11 we propose to set that lower bounds to be

12 equal to U.S. background, or ozone

13 concentration within the United States in

14 absence of all U.S. anthropogenic sources.

15 In the second draft we want to

16 evaluate a little further on possible

17 improvements of the quadratic rollback method. 

18 One thing that we are looking at is how we

19 could possibly use air quality models to

20 better understand how the atmosphere may

21 respond and may be meeting the current or

22 alternative standards.

Page 53

1 And we'd like to look a little bit

2 more at possibly using air quality models to

3 have some type of bounding on rollback by

4 putting through alternative NOx and VOC

5 emissions reductions into the model and

6 looking at how the atmosphere is responding to

7 those and how it's doing that to meet the

8 current and alternative standards.

9 So for the secondary standard, we

10 are for the first draft looking at recent air

11 quality, but for the second draft we will be

12 including information showing the W126 metric

13 when meeting the current and alternative ozone

14 standards. And we are currently looking at

15 how to do that type of rollback method.

16 So on the last bullet, the case

17 study selections, so for the exposure and the

18 city-specific risk assessments we are

19 proposing to analyze 12 cities and they are

20 listed here. Atlanta, Baltimore, Boston,

21 Cleveland, and for Detroit, Houston, Los

22 Angeles, New York, Philadelphia, Sacramento
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1 and St. Louis.

2 For the first draft, for the

3 exposure and for the clinical based risk

4 assessment, we are using only the four that

5 are bolded, with all 12 being included in the

6 risk assessment. And then in the second draft

7 all 12 will be included in the exposure and

8 both the risk assessments.

9 So in selecting these cities we

10 considered data availability, including the

11 availability of air quality monitoring data,

12 health study information, and then some data

13 that's very particular to exposure modeling

14 such as AC prevalence data.

15 We also looked at current air

16 quality values. We wanted to find cities that

17 were at or above the current levels, current

18 proposed ozone standard.

19 We also wanted to make sure that

20 we were including vulnerable populations and

21 that we had geographical heterogeneity across

22 the United States.

Page 55

1 And then, as we discussed before,

2 we'll be providing an evaluation to make sure

3 that these 12 cities are representative of

4 other major cities within the United States

5 with respect to risk.

6 Flipping to the next slide, some

7 more key issues to discuss with relation to

8 the primary standard. So for the exposure

9 assessment, for this time around we're going

10 to look at characterization of activities and

11 environments associated with high exposure and

12 risk, and we also will be including a

13 qualitative analysis of exposure avoidance

14 behavior.

15 And then in the second draft we

16 propose to include an expanded uncertainty and

17 sensitivity analysis, such as understanding

18 better the lung function risk or including a

19 better treatment of uncertainty with respect

20 to activity data or the use of ambient data in

21 the exposure model.

22 For the risk assessment for the

Page 56

1 clinical-based, we're looking at evaluating a

2 new FEV model by McDonnell, Stewart and Smith. 

3 We are also, as we discussed, looking at

4 estimating a total ozone risk without

5 consideration of background or the use of a

6 threshold.

7 And for the national analysis,

8 national scale risk assessment, we're going to

9 do a characterization of national distribution

10 of risk across major urban areas.

11 And then for the second draft we

12 hope to also include an expanded uncertainty

13 and sensitivity analysis, and, for example,

14 some things that we might be looking at there,

15 a possible use of a population-weighted

16 composite monitor estimate, or possible uses

17 of interpolation methods to fill in missing

18 data for ambient monitors and seeing what the

19 impact of risk is from doing that.

20 With respect to the long-term

21 metrics, we are currently evaluating air

22 quality metrics and the availability of health

Page 57

1 study information with respect to the long2 term metrics.

3 We are going to wait to see how

4 these results play out and also what CASAC

5 recommends, and then based on that we may end

6 up including in the second draft a sensitivity

7 analysis looking at long-term endpoint.

8 So going to the next slide, so the

9 last slide on the REA, looking at key issues

10 with respect to the secondary standard. So

11 for the first draft we are looking at just

12 recent air quality data, as we discussed, and

13 those years will be 2006 to 2008.

14 So we're going to be looking at

15 species-specific ecosystem service analyses. 

16 We're also going to be including for the first

17 time the FASOM and the i-Tree models looking

18 at large scale ecosystem effects using the

19 national scale air quality data.

20 And then for the second draft we

21 hope to include the W126 metrics in looking at

22 exposure for meeting the current and
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1 alternative standards, and then also including

2 some more specific case studies.

3 And then if the i-Tree model does

4 not get included in the first draft, which we

5 are hoping it does, it will be included in the

6 second draft in addition with some additional

7 modeling with FASOM with respect to using

8 rollback of the exposure data.

9 DR. HUBBELL: Can we take

10 questions?

11 MS. WEGMAN: Yes, let's take

12 questions.

13 DR. VEDAL: Yes, just with respect

14 to the risk assessment, you know, we

15 previously had two other approaches to the

16 risk assessment, something called -- I think

17 it was evidence-based, risk-based, something

18 like that. Now it's clinical-based and

19 epidemiologically-based.

20 So I just, a couple of questions,

21 the motivation for the change, and then

22 secondly, is there any correspondence between

Page 59

1 those two approaches?

2 DR. JENKINS: I'm sorry, this is

3 Scott Jenkins. Just a quick clarifying

4 comment. When you talk about evidence-based,

5 we typically talk about evidence-based

6 considerations in the policy assessment. It's

7 not part of the quantitative risk assessment,

8 so I think we're not talking about a change

9 here from going evidence-based to what Karen's

10 talking about. It's more -- she's talking

11 about specifically the quantitative risk

12 assessment. We will still be doing the

13 evidence-based considerations in the policy

14 assessment.

15 DR. HUBBELL: One more

16 clarification on that. This is Brian Hubbell. 

17 We still will be looking at, for example,

18 exposures above certain benchmarks of concern

19 that have been developed by looking at the

20 evidence.

21 So in the sense of what was done

22 in some of the past analyses was looking at

Page 60

1 exposures above certain levels that were tied

2 to observed health effects in clinical and

3 other studies, and we still will be including

4 that as part of the exposure analysis in

5 addition to actually estimating the clinical

6 responses that are based on the clinical

7 studies.

8 So it's still going to be there,

9 it's just that part of the exposure analysis

10 is not called out separately as a risk piece. 

11 It's part of the overall exposure assessment.

12 DR. SAMET: Okay, other -- Judy?

13 DR. GRAHAM: From the earlier plan

14 I had two major concerns about the exposure

15 assessment. One of them has been alleviated,

16 so I just wanted to say congratulations. 

17 You're doing all 12 cities and I don't know

18 how you accomplished that but whatever you

19 did, you done good.

20 The other question I have concerns

21 the APEX exposure model. I think very highly

22 of the model. My concern is the activity

Page 61

1 patterns that are embedded within it and how

2 recent are they.

3 So in other words, if NHAPS is the

4 major foundation it was done umpteen million

5 years ago, and since indoor/outdoor is a huge

6 factor in exposure, I worry about old activity

7 patterns not reflecting today's -- I don't

8 know whether you call them couch potatoes or

9 computer potatoes these days. I don't know

10 how you're going to deal with changing

11 activity patterns.

12 DR. HUBBELL: So John Langstaff,

13 who's our modeler for APEX, is not here today,

14 but what we're planning to do is we've been

15 incorporating additional information on

16 activity data that's available.

17 For the first draft we're going to

18 use all the data that we have available to us. 

19 One of the sensitivity analyses that we are

20 hoping to do for the second draft is to try to

21 split the data by older and newer activity

22 data to be able to look at the potential
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1 impact of changes in those activity patterns. 

2 The degree to which we'll be able

3 to actually do that is not clear yet because

4 of the sample sizes in the different groups,

5 but our hope is that we'll be able to at least

6 start looking at some of that.

7 There was also hope that we'd be

8 able to use some of the newer datasets such as

9 the ATUS dataset, the American Time Use

10 Survey, which is a national survey that has a

11 lot of additional data. But, again -- and

12 it's got data at different time points over

13 the last several decades.

14 So we're hoping to be able to try

15 to address some of the questions. It may not

16 be in the first draft but we hope to have some

17 sensitivities and least in the second draft.

18 DR. SAMET: Fred?

19 DR. MILLER: Back to your Slide 6,

20 can you explain to me why you are going to not

21 have a consideration for background? That

22 you're doing this total health effects

Page 63

1 incidents and -- because it doesn't exist of

2 zero exposure to ozone anywhere.

3 And as a corollary to that, if you

4 go that route, to what extent do you

5 complicate or have to do over things where you

6 eventually will end up considering some level

7 for policy background level?

8 DR. SAMET: And, actually, before

9 you answer that, because I was going to raise

10 the same concern, and I know you must have

11 thought about this, but to sort of entertain

12 a counterfactual that truly is unachievable is

13 an important decision.

14 And I think I guess the other

15 addendum I would make to what Fred

16 appropriately asked is, if you do it for one

17 pollutant are you going to do it for others?

18 MS. WESSON: So our motivation for

19 doing this, you know, was to better understand

20 total ozone risk. So whether the source of

21 ozone is coming from overseas or is coming

22 from a plant or it's coming from a source

Page 64

1 within the United States, it's still producing

2 ozone and it's still contributing to risk. 

3 And so to us it was important to understand

4 what the total ozone risk was and to leave any

5 possible implementation questions to the REA

6 or to the implementation world later on.

7 And we kind of felt like

8 consideration of background really started

9 wading into the implementation world. It was

10 basically a consideration of what was

11 possible, how would this actually be

12 implemented? And so we felt like it wasn't

13 part of the REA policy questions that we were

14 trying to address.

15 DR. HUBBELL: And one other

16 clarification I had, one of the reasons why

17 this has become more troubling to me over the

18 years that we've been doing this, applying

19 this artificial background, is that we also

20 tie to our standards. We tie our air quality

21 index, for example, in our statements about

22 public health significance of the certain

Page 65

1 exposures. And those should be based on where

2 you expect to see the public exhibiting

3 certain health responses to ozone, and that

4 really is not tied to how much is coming from

5 the U.S. or how much is coming from natural

6 versus anthropogenic. It's tied to total

7 ozone exposure.

8 So understanding the risk that's

9 associated with the exposure we felt like was

10 the appropriate benchmark for beginning the

11 consideration of what an appropriate NAAQS

12 level should be.

13 Again, as Karen mentioned, when we

14 are looking at the incremental changes in risk

15 that are associated with meeting current and

16 alternative standards then we must consider,

17 you know, what is the likely ways in which

18 that reductionism would occur. And that's why

19 we've put in the U.S. background now and we're

20 considering these alternative approaches as we

21 move into the second draft.

22 But in terms of stating what the
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1 risks associated with ozone is, unless we have

2 scientific evidence that there is a threshold,

3 which again we noted that that becomes more

4 important now and that's why we highlighted

5 that we're not including a threshold based on

6 the current ISA conclusions that there is no

7 threshold, but it raises the relevance of the

8 threshold question to a much higher level when

9 we're not incorporating an air quality

10 background into the risk calculation.

11 So it's very important and we

12 understand that this is going to be something

13 that we need a lot of discussion on which is

14 why we wanted to highlight it now.

15 DR. SAMET: So why don't we call

16 this Round 1 of these discussions. I'm sure

17 there will be more. I'm actually a little bit

18 reminded and you might revisit it, the

19 discussions we had when we did BEIR VI, the

20 radon risk assessment, which EPA has adopted.

21 And there the so-called comparison

22 was counterfactual for radon risk reduction

Page 67

1 indoors was outdoor concentration which is

2 fixed by nature and no one is going to lower

3 it, not even EPA.

4 But the same considerations were

5 there, and if you look at actually how we

6 looked at the attributable risk, we developed

7 concepts of effective attributable risk of

8 what might actually be mitigated against an

9 unachievable zero indoors that is equivalent

10 to what was outdoors.

11 And I think conceptually some of

12 the same issues were laid out there, but I'm

13 sure that we will return to discussion when we

14 see how you provide a rationale for this in

15 writing, which I think is going to be

16 critical.

17 Fred, and then Joe.

18 DR. MILLER: Can you clarify when

19 you say the implementation phase? Are you

20 saying that you're taking it out of the whole

21 process and it would be the risk manager at

22 the end saying, "well, I kind of feel like

Page 68

1 policy relevant background is .08, and so

2 therefore, here's what my standard will be,"

3 as opposed to the science of that interplay

4 between science and policy were to say, "here

5 is where we feel is a reasonable range."

6 I'm not sure what you mean by

7 saying saving it to the implementation. Are

8 you talking about SIPS and the whole thing

9 down the stream that is out of the realm after

10 this kind of a review? If so, I've got a real

11 problem with that.

12 DR. HUBBELL: Well, again, what

13 we're trying to get a better handle on, and

14 again there's going to be a lot of discussion

15 in the first draft risk and exposure

16 assessment about both our consideration of

17 what is the policy concept we're trying to

18 address, but also the potential ways of

19 looking at rollbacks when you're looking at

20 incremental risk reductions, which again we're

21 setting the standards. We're looking at

22 incremental improvements over where we

Page 69

1 currently are, and again, background can come

2 into those discussions about what is the ways

3 in which that risk reduction would be

4 achieved.

5 What we're saying is that when

6 we're looking at the total risk, and which is

7 our -- basically what's the size of the pie

8 that we have to work with? That we think it's

9 appropriate to get a benchmark level of that

10 that's based on the total risk from total

11 ozone exposure, rather than focusing on

12 identifying only the risk that is supposedly

13 achievable, which, again, it's a policy

14 discussion as to whether that's achievable

15 through U.S. policy or not.

16 You know, the concept of truly

17 natural background, one of the discussions

18 we've had is that it's a very difficult

19 concept. Because of the nonlinearities in

20 ozone formation it's very difficult to

21 determine exactly what you mean by natural

22 background ozone.
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1 The counterfactual of what would

2 happen if you zeroed out all anthropogenic

3 emissions, that's a very different concept

4 than what is attributable to anthropogenic

5 emissions within the current concentration of

6 ozone. And those are very difficult and

7 different concepts.

8 And we're not sure that it was

9 relevant determining what overall risk we are

10 trying to address in terms of total ozone. 

11 What we really have to decide is how do we

12 weigh these different concepts of background

13 when we're considering the incremental

14 reductions in risk that you might achieve by

15 setting different standards. And that's why

16 we're trying to change the focus towards the

17 incremental differences between standards

18 rather than on total risk.

19 DR. SAMET: So let me see who else

20 wants to come up. I think Joe and Dave and

21 then Judy and -- okay, Joe?

22 DR. BRAIN: It's clear that

Page 71

1 background is important, contentious, complex,

2 and I just have a simple point. It seems to

3 me we need to have a little bit about

4 background in the preamble, but that's really

5 going to become kind of a universal document. 

6 I think it's currently absent, but

7 I'd like to see, you know, number one, to

8 clarify when the background is appropriate to

9 consider. Is it the ISA, the REA, the policy

10 document? I think that should be reflected in

11 the preamble if it's really going to be as

12 useful as possible.

13 DR. SAMET: David?

14 DR. CHOCK: Yes, I have a question

15 regarding the statistical issue of the

16 background. When you're talking about the

17 lower bound of the background are you talking

18 about the mean or the background distribution?

19 DR. HUBBELL: We're referring to

20 the background distribution.

21 DR. SAMET: Judy?

22 DR. GRAHAM: I see words here,

Page 72

1 public health, health effects. I don't see

2 the word adversity. And I guess this is a

3 question.

4 There can be a statistically

5 significant change in a health indicator from

6 a human clinical study and it can be

7 replicated in 20 labs, et cetera, and it is

8 what it is. There is then the question of

9 what's its adversity level.

10 What do you all feel is the

11 relationship between the ISA and your policy

12 determinations to call an effect "adverse"? 

13 In other words, who's responsibility is it to

14 talk about, you know, like the severity of the

15 effect versus this effect is severe enough

16 that I'm going to call it adverse?

17 Who does that and what do you need

18 from us to help you with that?

19 DR. JENKINS: So the ISA does have

20 some information on adversity of responses. 

21 I mean, you have a surface spectrum of

22 adversity, going from the types of effects you

Page 73

1 see in clinical studies going all the way up

2 to the epi studies looking at mortality where

3 you have the more clear adverse responses.

4 With regard to the human clinical

5 end of things, we would be in the policy

6 assessment pulling from the ISA considerations

7 of adversity, and there is some, like I said,

8 some discussion in the ISA right now of

9 adversity of responses based on ATS

10 definition, based on some other factors.

11 So we will be pulling that into

12 the policy assessment as part of what we refer

13 to as our evidence-based considerations. So

14 part of those considerations will be

15 consideration of adversity of the response.

16 DR. SAMET: In the spirit of Joe's

17 mention of the preamble, this might be a

18 preamble sort of issue. That is, it's cross19 cutting and general and what you say with

20 regard to ozone should hold with regard to any

21 other of the pollutants. They might give that

22 consideration. Also remember the ATS document
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1 was written, I think published in 2000, so --

2 and there may be other considerations you want

3 to bring in.

4 Daniel?

5 DR. JACOB: Yes, hi. I certainly

6 appreciate it and I'm supportive of looking at

7 total ozone in terms of effects. But some of

8 the motivations presented for doing that

9 disturb me a little bit. In particular,

10 Brian, when you talked about nonlinearity of

11 ozone formation and the difficulty of

12 attributing an ozone molecule to an

13 anthropogenic or natural source.

14 Well, we can very well quantify

15 the anthropogenic enhancements of ozone and

16 from various sources, although we cannot label

17 a molecule as anthropogenic or natural we can

18 determine how human activity is affecting

19 ozone levels.

20 So I would take this out of the

21 argumentation. I think you have other very

22 good reasons for looking at the effect from

Page 75

1 total ozone.

2 DR. SAMET: Fred?

3 DR. MILLER: Given that you're

4 talking about, for the risk assessment,

5 extracting things from the ISA, it becomes

6 even more important that the ISA is correct. 

7 And I have to say your new figure,

8 2.3, for the ISA, you have got the same color

9 for altered development of the respiratory

10 tract or altered morphology as airway

11 responsiveness, and that just flat doesn't

12 fly.

13 And so when you have the primates

14 exposed to 0.15 and you have an alteration

15 permanently that would translate over in terms

16 of homology to children, and you have

17 considering these things as just -- they're

18 the same yellow as a temporary change in

19 airway responsiveness, we're going to have to

20 have some discussion about that because this

21 figure to me is extremely misleading and could

22 be misused as far as carrying over to what you

Page 76

1 should focus on.

2 DR. SAMET: Jim?

3 DR. ULTMAN: I was wondering about

4 how you're envisioning characterizing the

5 decrement in FEV1 from the clinical studies. 

6 The ISA relies very heavily on using a so7 called induced ozone effect by using filtered

8 air as the relative measure. Whereas there

9 are other suggestions, some from external

10 reviewers that we'll hear, that one should use

11 some low level or background level with

12 respect to that reference. And I'm wondering

13 what your current thinking on that is.

14 MS. WESSON: So John Langstaff

15 unfortunately is not here. He would know more

16 of the details. But I don't think that we've

17 made any decisions quite yet. I think that's

18 something that we're still trying to figure

19 out exactly how to include.

20 So I think we would -- maybe we

21 could follow up with getting an answer from

22 John for you.

Page 77

1 DR. SAMET: The left wing of CASAC

2 has been very active. What about the right?

3 (Laughter.)

4 Helen?

5 DR. SUH: Hi, I was just wondering

6 if you could comment on your approach for

7 bringing forward some of the health results

8 for the REA and the policy assessment. So,

9 for example, are you going to bring forward

10 ones that are determined to be causal or

11 likely to be causal, or what is the -- is it

12 based on data or --

13 DR. JENKINS: Yes, it is based on

14 the strength of the evidence. So we tend to

15 put, in both the REA and the policy

16 assessment, the most weight on the health

17 endpoints that have been judged in the ISA to

18 be causal, where the evidence is judged

19 sufficient to support a causal relationship

20 and a likely causal. 

21 So we'll be placing most weight,

22 and this is consistent with the way we've done
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1 in other reviews where we've put most weight

2 on causal, likely causal effects and then when

3 we get to suggestive and lower we think about

4 them within the context of margin of safety5 type considerations.

6 DR. SUH: I seem to recall in the

7 PM that there was some ones that were

8 suggestive, for example, that were also

9 included, and I don't remember that being done

10 for this, like, margin of safety kind of --

11 DR. JENKINS: So on coarse

12 particles for PM we had a whole body of

13 evidence that was suggestive, and that was

14 basically that the highest weight of evidence

15 judgment that was in the ISA for coarse. And

16 so basically in the policy assessment

17 everything was based on that suggestive

18 evidence.

19 In the terms of quantitative

20 assessment for PM with the suggestive

21 evidence, we didn't do a quantitative

22 assessment for coarse.

Page 79

1 DR. SUH: I guess I'm wondering

2 specifically is for the long-term mortality

3 for ozone, you know, there have been some

4 studies and in the ISA it's suggestive.

5 And I guess I'm just wondering

6 what's going to happen with that, because

7 that's a very important outcome. And I think

8 to me it's sort of on the cusp of whether you

9 include it or you don't, so I guess --

10 DR. JENKINS: And I think Karen

11 alluded to this when she was talking is that

12 what we are going to do on the long term

13 quantitatively is still very much something

14 that's under consideration, and I think

15 something that we'd be looking for feedback

16 from the panel on.

17 Certainly in the policy assessment

18 we will be looking at the extent to which, you

19 know, the current short-term standard protects

20 against long-term effects that have been

21 linked to long-term exposures, but in terms of

22 quantitative assessment of long-term risks I

Page 80

1 think we would be looking for feedback from

2 the panel on that.

3 DR. SAMET: Let me check. Do you

4 still have a few slides to do on the policy

5 assessment? Maybe we'd better move on to

6 those and then just -- not to quiet the right

7 too much.

8 MS. WEGMAN: I was just about to

9 say, in light of time we probably should

10 quickly go through those and then see if there

11 are any other questions.

12 DR. JENKINS: Okay, so I'm going

13 to just talk quickly through the last three

14 slides, which will focus on the policy

15 assessment, starting with an overview of the

16 structure of the policy assessment.

17 So after we do the introductory

18 background materials the policy assessment

19 will be divided into two main parts. Chapters

20 2 through 4 covering the primary standard and

21 Chapters 5 through 7 covering the secondary

22 standard. Having basically parallel

Page 81

1 structures with Chapters 2 and 5 looking at

2 the effects evidence, Chapters 3 and 6 looking

3 at -- pulling from the REA, looking at the

4 estimates of exposure some risks, and then

5 Chapters 4 and 7 laying out stats, preliminary

6 conclusions regarding the standards, the ozone

7 NAAQS. So it's a quick overview of the

8 structure.

9 Now in terms of key issues, with

10 regard to the primary standard, in the first

11 draft we'll be focusing on the adequacy of

12 public health protection provided by the

13 current ozone NAAQS.

14 We'll be looking at, as we just

15 talked about, effects that have been linked to

16 both short and long-term exposures. So we'll

17 be considering the evidence, and Dr. Vedal

18 alluded to this, the evidence-based

19 considerations. We will have these evidence20 based considerations. We'll be considering

21 health effects evidence that links ozone to

22 both short-term and long-term exposures.
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1 And then we'll be pulling from the

2 first draft REA -- at least in the first draft

3 policy assessment we'll be pulling from the

4 first draft REA where the REA estimates ozone5 related exposures, ozone-related health risks,

6 in areas that just meet the current ozone

7 standard. And this will be done through the

8 types of simulations that we always do where 

9 we adjust air quality to simulate just meeting

10 that current standard.

11 The other thing that will be

12 included in the first draft is identification

13 of range of potential alternative standards

14 that will be a focus for assessment in the

15 second draft of the REA, in the second draft

16 policy assessment. And that will be largely

17 based on looking at the health evidence to lay

18 out that range of potential alternative

19 standards for future consideration.

20 In the second draft of the policy

21 assessment, in addition to looking at adequacy

22 of the current standard, we'll be looking at

Page 83

1 adequacy of the range of potential alternative

2 standards, pulling not only from the health

3 evidence but also pulling from the second

4 draft of the REA,\ the simulations that will

5 be included in that second draft REA looking

6 at quantitative estimates of exposure, some

7 risks that are associated with the different

8 standards within the range of alternatives. 

9 So that's with regard to the

10 primary standard, and then quickly the

11 secondary standard following a similar type of

12 approach. The exception being that the first

13 draft REA is going to look at risks to

14 ecosystem services under current conditions

15 not simulating the current standard. That'll

16 be pushed into the second draft of the policy

17 assessment on the secondary standard side.

18 And, again, in the first draft

19 we'll lay out a range of potential

20 alternatives that are appropriate for our

21 further evaluation, but actually evaluating

22 the current, and that range of potential

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1 alternatives will be put into the second draft

2 of the policy assessment.

3 MS. WEGMAN: So that's it for our

4 presentation, and I know we're short of time

5 but we appreciate all the comments we've

6 gotten and if there are more we'd love to hear

7 them.

8 DR. SAMET: Okay, so maybe there

9 are a few quick comments. Dave?

10 DR. GRANTZ: I have a quick

11 question on your idea for the second draft of

12 the REA. It was Karen's Slide 6. What do you

13 see as the issues in rolling back the W126? 

14 You say you're evaluating rollback techniques

15 for this.

16 MS. WESSON: Sure. So if we were

17 to just do rollback of one monitor it wouldn't

18 be so hard. We'd adjust that monitor, you

19 know, using like the quadratic rollback

20 approach or something similar to meeting the

21 current ozone standard and alternative

22 standards and then take that data and

Page 85

1 calculate a W126 metric. So that wouldn't be

2 so difficult.

3 But what the problem is is that we

4 want to do this on a national scale, so we

5 have this fused surface of ambient data and

6 modeling data and we have to figure out a way

7 to roll that surface back to meet the current

8 ozone standard and then translate that to a

9 W126 metric.

10 So we have, you know, some

11 techniques that we're exploring of whether we

12 can roll back the monitors and then still use

13 the model to fuse the surface in between,

14 assuming that the model is still predicting

15 those gradients the same, just how we use the

16 model and the fused surface. You know,

17 perhaps we could go down that road. But we

18 just want to be a little bit more thoughtful

19 and think through how to get that national

20 surface of rolled back data.

21 DR. GRANTZ: So you see the

22 problem being of spatially assigning the
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1 metric rather than actually rolling back

2 effects?

3 MS. WESSON: Yes, I think it's

4 spatially representing that W126 metric rolled

5 back in areas where there's no monitors being 

6 the biggest challenge.

7 DR. GRANTZ: Okay, thanks.

8 DR. SAMET: Well, thank you for

9 your presentations. I will say the thing that

10 I think caught the attention of many of us was

11 this idea of total risk.

12 And I think you're going to have

13 to make certain that -- and maybe we're going

14 to see obviously documents in May, June -- but

15 that there's a very clear explication of what

16 this is, why you're doing it and how this

17 follows into from REA to policy analysis.

18 As you said, there's of course --

19 you could also calculate total PM risk, and

20 you're setting a precedent that potentially

21 spills over to PM, which of course has myriad

22 uncontrollable sources. So I think the

Page 87

1 formulation of this is going to be very

2 important. We'll look forward to seeing how

3 you actually say why you're doing it and what

4 you are doing, and then I think we'll be able

5 to comment further.

6 MS. WEGMAN: Thank you, Jon, and

7 thanks for raising the precedential issue,

8 because I think it's an important one that we

9 need to consider as we move forward and

10 whether there's something distinct about ozone

11 if we follow this path or whether, in fact, it

12 would apply to other pollutants.

13 DR. SAMET: Okay, thanks, and I

14 think we'll move on to the public comment

15 period. Aaron's going to describe a little

16 bit of our logistics.

17 MR. YEOW: Okay, so we're going to

18 ask the public speakers to come up front. We

19 passed out a list of public speakers and so

20 we're just going to go in order there. I

21 believe our first one's on the phone.

22 But we'll just ask the public

Page 88

1 speakers to come up to the front there and

2 we'll give you five minutes. You'll see there

3 are lights on the table there. So it'll turn

4 green when you're within your allotted time. 

5 When you have one minute left it'll turn

6 yellow and then when your time's up it'll be

7 flashing red. And at that point Dr. Samet may

8 interrupt you -- will interrupt you to let you

9 finish your sentence. For those on the phone

10 we will publicly announce when you have one

11 minute left.

12 So those public speakers, maybe

13 you could just start preparing yourselves off

14 to the side here. We have an hour and a half

15 allotted with a break in between. We'll just

16 leave that to the discretion of the Chair to

17 when we want to break for the --

18 DR. SAMET: Right, so we will aim

19 for a break at approximately 10:30, so we'll

20 see how many of our public commenters we can

21 hear from before the break.

22 So Aaron has outlined, you will

Page 89

1 have five minutes, and after the five minutes

2 there may be questions or comments from CASAC

3 members.

4 So, let's see, our first public

5 speaker is George Wolff from Air Improvement

6 Resource, Inc. Let's see, George, are you on

7 and ready?

8 DR. WOLFF: Yes, I am, Jon.

9 DR. SAMET: Okay, George, thanks. 

10 And as you heard from Aaron, we will announce

11 when you've hit the four-minute mark. Why

12 don't you go ahead.

13 DR. WOLFF: Thank you. Good

14 morning, I'm George Wolff. I'm presenting

15 comments for the Alliance of Automobile

16 Manufacturers. John Heuss and I have prepared

17 extensive comments on the ISA which I

18 encourage you to read. However, today I'm

19 going to focus strictly on background ozone. 

20 Figure this issue is extremely

21 important because PRB sets a limit on the

22 amount of risk that can be reduced. The lower
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1 the PRB, the more risk reduction EPA can

2 claim. 

3 Anne Smith has shown that if EPA

4 had used a PRB of 40 instead of 15 to 35 which

5 they used in 2007, 92 percent to 100 percent

6 of the risk would have disappeared.

7 PRB also establishes the ozone

8 level that can be achieved from state and

9 federal control programs. An underestimation

10 of actual PRB will result in failed control

11 strategy.

12 There have been a number of

13 modeling estimates of PRB since the last staff

14 paper. All the PRB estimates since the staff

15 paper have been higher than what the staff

16 paper estimated.

17 The mean April to August PRB has

18 increased incrementally with each additional

19 study, and the highest levels that have been

20 found were the most recent one by Emery using

21 CAMx.

22 However, the 2007 staff paper

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1 inappropriately used mean monthly diurnal

2 profiles of the PRB. This fails to capture

3 the daily variation and the important fourth

4 highest daily eight-hour maximum

5 concentration.

6 Zhang found that the fourth

7 highest eight-hour concentrations for the U.S. 

8 be in the range of 35 to 45, but in the

9 Intermountain West this is 50 to 60 parts per

10 billion.

11 DR. SAMET: George, I'm sorry to

12 interrupt but I just want to make sure that

13 we're sequenced with your slides. Which slide

14 would you like to have shown right now?

15 DR. WOLFF: I am on one, two,

16 three, fourth slide, I believe.

17 DR. SAMET: Okay, and we'll give

18 you an extra 30 seconds for the interruption.

19 DR. WOLFF: Okay, thanks. 

20 However, when total ozone was greater than 60,

21 the PRB frequently exceeded 50 in the West and

22 40 in the Midwest.

Page 92

1 Now you should be on the slide

2 with the graph. And this shows that paired3 in-time ozone and PRB are positively

4 correlated at all the sites that were

5 examined. This means that PRB is higher when

6 total ozone is higher.

7 We conclude that EPA needs to use

8 daily eight-hour PRB estimates based on CAMx,

9 not monthly averages. PRB is also an

10 inappropriate measure of achievable ozone

11 levels in the East and Southwest because of

12 significant contributions from Canada and

13 Mexico.

14 The average enhancement of U.S.

15 background over PRB is shown here and it

16 ranges from 22 in Maine to 5 in Michigan. 

17 However, just like it is inappropriate to use

18 monthly average PRB, it is inappropriate to

19 use monthly average enhancements. Examples

20 include but are not limited to Big Bend,

21 Texas, where frequent excursions of 50 ppb

22 occur and one of 70 occurred.

Page 93

1 In Unionville, Michigan, based on

2 modeling in 2001, on several occasions the USB

3 exceeded 40 ppb. Three times the total ozone

4 exceeded 75 with Canadian enhancements

5 exceeding 10, and two times Canadian

6 enhancement exceeded 30.

7 Based on this, we conclude that

8 the U.S. Background, not PRB, should be used

9 in the East and Southwest in the U.S. for risk

10 assessments and SIP planning.

11 Thank you, I'll be happy to answer

12 any questions.

13 DR. SAMET: Thank you, and on

14 time. Yes, Fred?

15 DR. MILLER: George, can you tell

16 me for the Denver, the plot that you have, was

17 that the background monitor from that area

18 close there, or what's the geographic spatial

19 distribution for what kind of monitor was used

20 to assess the PRB in this area?

21 DR. WOLFF: That is the rural

22 background monitor in the Denver area.
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1 DR. MILLER: Thank you.

2 DR. SAMET: Okay, any other

3 questions for our speaker? Okay, good. Thank

4 you, George. Our next speaker is G. Bruce

5 Copley, ExxonMobil Biomedical Sciences, Inc. 

6 Please go ahead.

7 DR. COPLEY: Thank you, Jon. I am

8 Bruce Copley, an epidemiologist from

9 ExxonMobil Biomedical Sciences, and I want to

10 comment on two areas of concern that I have. 

11 Number one, the EPA's cumulative

12 weight of the evidence methodology in general,

13 and two, the Agency's application of this

14 methodology for long-term or chronic ambient

15 ozone exposure and respiratory mortality.

16 The EPA's weight of evidence scale

17 is as follows, causal, likely to be causal,

18 suggestive of a causal relationship,

19 inadequate to infer a causal relationship and

20 not likely to be causal.

21 This framework is imbalanced, as

22 three of these five designations indicate or

Page 95

1 suggest causality with no analogue for

2 designating noncausal evidence. The middle or

3 third category is not neutral as is commonly

4 seen such as in Likert Scales, rather it is

5 designated as suggestive. Moreover, the most

6 certain designation of the noncausality is

7 phrased in a manner that allows for the

8 possibility of a causal association.

9 This weight of evidence scale has

10 not received scientific peer review for use in

11 observational studies. Scientific peer review

12 is required for studies to be considered by

13 EPA in these NAAQS determinations. Likewise,

14 we believe that this new weight of evidence

15 framework should also be peer reviewed.

16 I will now address the EPA's

17 criteria for those designations. The basis

18 for causal is more compatible with a likely to

19 be causal classification under a more

20 objectively scientific paradigm.

21 The Agency's acceptance that

22 chance, bias and confounding can be ruled out

Page 96

1 with reasonable confidence in observational

2 studies is not defensible, particularly in

3 light of the observed weak statistical

4 associations.

5 Consider the relative risk of 1.04

6 for respiratory mortality in Jerrett 2009,

7 which is arguably the most influential paper

8 on chronic ozone mortality.

9 As in many other chronic air

10 pollution studies, the role of chance is

11 reduced owing to the large sample size. 

12 However, there are many opportunities for

13 uncontrolled bias and confounding to render

14 that relative risk as unreliable.

15 The effect of confounding by a PM

16 alone in this study and many others is almost

17 certainly greater than the effects of ozone

18 exposure. Likewise for the ever-present

19 exposure misclassification which for ozone can

20 be substantial. Unexplained regional

21 heterogeneity of effect in Jerrett et al.

22 further adds to the concerns about

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1 reliability.

2 The Agency offers examples of

3 support for earning the causal designation as

4 follows. A, controlled human exposure studies

5 that demonstrate consistent effects, or B,

6 observational studies that cannot be explained

7 by plausible alternatives or are supported by

8 other lines of evidence such as animal studies

9 or mode of action information.

10 Controlled human exposure studies

11 cannot replicate real-world chronic exposure. 

12 Consequently, observational studies with their

13 attendant weak statistical associations are

14 relied on to examine health endpoints.

15 It seems entirely plausible that a

16 constellation of factors other than ambient

17 ozone exposure, but somehow associated with

18 such exposure, could have generated those

19 small relative risks.

20 The potential for alternative

21 causal agent is high given that the stationary

22 ambient monitor measurements are a poor
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1 surrogate for individual and population

2 average exposure for use in epidemiology

3 studies.

4 The remaining causal criterion is

5 "evidence includes replicated and consistent

6 high quality studies by multiple

7 investigators." True replication is

8 essentially nonexistent in observational air

9 pollution epidemiology.

10 Even studies of the same

11 population such as the ACS cohort, update the

12 data or use analytical tools that differ from

13 those of previous studies. Additionally, I

14 submit that studies which lack individual

15 exposure data and cannot adequately control

16 confounding, which are characteristics of

17 those studies now being considered for chronic

18 ozone mortality, cannot establish causality. 

19 True, some studies are stronger

20 than others, but relativism should not be used

21 as a substitute for reliability when assessing

22 the weight of evidence.

Page 99

1 Chronic mortality is a new health

2 endpoint that the EPA proposes to quantify in

3 their risk and exposure assessment and

4 regulatory impact analysis for the 2013 ozone

5 NAAQS.

6 The Agency has determined that the

7 evidence for a mortality effect is suggestive

8 of a causal relationship. Here the criteria

9 for this designation.

10 Evidence is suggestive of a casual

11 relationship when relevant pollutant

12 exposures, but is limited because chance, bias

13 and confounding cannot be ruled out. For

14 example, at least one high quality epi study

15 shows an association with a given health

16 outcome but the results of other studies are

17 inconsistent.

18 Now this allows for the

19 possibility that one so-called high quality

20 study that contradicts findings from several

21 other studies could raise that designation

22 from inadequate to infer a causal relationship

Page 100

1 to a suggestive.

2 In short, this weighting paradigm

3 and its associated criteria is of questionable

4 validity with a bias towards designations that

5 exaggerate the certainty of causal inference. 

6 In addition, there is insufficient evidence

7 for the suggestive designation for the

8 ozone/mortality relation.

9 Thank you for this opportunity.

10 DR. SAMET: Thank you. Comments,

11 questions? Fred?

12 DR. MILLER: I personally agree

13 with the suggestion that you have made that

14 the Agency should have a peer review of their

15 categories and that this is a very strong

16 situation.

17 And I was wondering to what extent

18 the other ones that you've cited, were they

19 categories that were subject to peer review

20 and publication so that there was a

21 consistency for the given field?

22 DR. COPLEY: I'm sorry, this

Page 101

1 weight of evidence scales that I want to have

2 them address here, are you talking about other

3 weight of evidence schemes or --

4 DR. MILLER: Yes, you refer to

5 other category scales in that, and were those

6 scales peer reviewed and come to some

7 consensus and that's why you're suggesting

8 that --

9 DR. COPLEY: Well, I referred to

10 Likert Scales which are a common paradigm used

11 in like surveys. But I'm not talking about a

12 competing weight of evidence scheme at this

13 point. Though I'm sure there are other ones

14 out there, I just want to address this one

15 today.

16 DR. SAMET: Let me comment, I

17 think perhaps provide some background and

18 refresh everyone's memory about these

19 categorizations.

20 There was a substantial amount of

21 interplay between this panel and EPA staff at

22 the time of sort of the redo of these
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1 classifications, and suggestions that EPA look

2 at, for example, what was being used by the

3 Surgeon General's report. That was updated in

4 2004.

5 Sverre and I both served on an IOM

6 committee that did substantial work on looking

7 at causal classifications, causal schemes. 

8 That was the report on presumptive disability

9 decision making for veterans that has three or

10 four chapters devoted to this question.

11 And all of these materials were

12 peer reviewed, and I know there were Agency

13 discussions about these categories. So this

14 was looked at fairly carefully, Fred. I think

15 this goes back actually to the sort of the

16 time when I took over as Chair.

17 I would say just as a matter of

18 designations, this is not really about having

19 something analogous to a Likert Scale. I

20 think the PDDM, the IOM report actually does

21 a pretty good job of saying, well, what we'd

22 really like to do is quantify the degree of

Page 103

1 certainty and lay that out, and that of course

2 is a challenge.

3 In terms of anchoring at the

4 bottom, this is looked at by a number of

5 groups. For example, IARC, the International

6 Agency for Research on Cancer, has a category. 

7 I think the concern is that one

8 can never exclude the possibility that there

9 might be some association, and I think that's

10 why there's always been a little hedging in

11 the language for the bottom end of these

12 categories. So I think I just want to make

13 clear about the origins and the nature of

14 these scales.

15 Any other questions for Dr.

16 Copley? Okay, thank you, and we'll move on to

17 our next commenter also on by phone, Neeraja

18 Erraguntla from the Texas Commission on

19 Environmental Quality.

20 So are you ready to go? And since

21 you're on the phone we'll give you the four22 minute warning.

Page 104

1 DR. ERRAGUNTLA: Hello, yes, can

2 you hear me?

3 DR. SAMET: Yes, please go ahead.

4 DR. ERRAGUNTLA: Good morning, I

5 am Dr. Neeraja Erraguntla and I'm the Senior

6 Toxicologist at the Texas Commission on

7 Environmental Quality. I would like to thank

8 EPA for this opportunity.

9 But today I have four main points

10 to discuss. However, more extensive comments

11 are provided in our previously submitted

12 written comments.

13 Point number one, the EPA should

14 be transparent in its process of choosing key

15 studies and provide clear documentation of how

16 it arrived at its conclusions.

17 In order to determine that there

18 is sufficient evidence of an association there

19 must be an observed relationship between

20 exposure and health outcome in studies in

21 which chance, bias and confounding variables

22 could be ruled out with reasonable confidence. 

Page 105

1 However, many studies heavily

2 relied by the EPA in the ISA are inadequate to

3 demonstrate sufficient evidence of an

4 association between short and long-term

5 exposures to ozone, cardiovascular, central

6 nervous system effects and mortality.

7 One key concern of the National

8 Academy of Sciences was EPA's consistent

9 failure to document how studies are selected

10 for review. For example, the exclusion by EPA

11 of well conducted studies if the results

12 showed no adverse health effects and the EPA

13 policy of discounting or ignoring studies

14 showing no association between ozone exposure

15 and asthma exacerbation.

16 Point number two, the roles of

17 uncertainty and bias in EPA's assessments have

18 been severely downplayed. It is essential

19 that EPA clearly discuss and characterize

20 these uncertainties.

21 For ozone, EPA relies on studies

22 that estimate personal exposure by using
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1 ambient monitoring data as a surrogate for

2 personal exposure. However, it is very

3 unlikely that people would ever be exposed to

4 these pollutants at concentrations measured at

5 outdoor monitors for very long periods of

6 time.

7 In fact, the average American

8 spends a large amount of time, close to 82

9 percent of time indoors, especially during the

10 heat of summer when ozone concentrations tend

11 to be at their highest.

12 Therefore, this assumption that

13 the personal exposure of an average American

14 is similar to ambient ozone concentration

15 oversimplifies and incorrectly assumes that

16 ambient monitoring data accurately reflects

17 personal exposure.

18 Point number three, it is

19 imperative that EPA distinguish true risk from

20 just association because associations are not

21 causations. While it may be possible to find

22 an association during statistical manipulation

Page 107

1 of data, this does not necessarily demonstrate

2 causation. Application of the modified Hill

3 criteria is necessary to start to prove

4 causality.

5 Ecological epidemiological studies 

6 are hypothesis-generating studies and are not

7 scientifically rigorous enough to be used as

8 a basis for policy decisions. In fact, these

9 studies used patient histories to monitor

10 exposure and assess health effects. Such

11 records are inadequate indices to associate

12 ozone exposure and health effects.

13 Further, meta-analysis of

14 ecological studies may give the appearance of

15 hard data but they have an extremely poor

16 exposure component and studies conducted to

17 date only show slight associations.

18 Point number four, EPA should rely

19 on biological and not statistical significance

20 in identifying an adverse health effect in

21 clinical studies. The definition of an

22 adverse effect with regard to exposure to air

Page 108

1 pollutants still remains ambiguous.

2 Clinical studies evaluating health

3 effects due to ozone exposure have mainly

4 focused on decreases in lung function as

5 measured by forced expiratory volume in one

6 second. However, it has been found that daily

7 normal activities, exercise and diurnal

8 variations can themselves cause up to five

9 percent to 17 percent decrease in FEV1. Many

10 agencies have indicated at least 20 percent

11 decrease in FEV1 as an adverse effect.

12 Adams study and other clinical

13 studies have shown that ozone exposures of

14 0.06 ppm have reported only subtle

15 statistically significant effects that are not

16 only within the intra-individual variability

17 but are also substantially less than the 20

18 percent decrease in FEV1 to be found adverse.

19 In summary, despite lack of

20 compelling evidence, the ISA --

21 DR. SAMET: One minute.

22 DR. ERRAGUNTLA: -- concludes

Page 109

1 causal associations with long-term exposures

2 of ambient ozone and mortality. Further, the

3 ISA includes conclusions regarding a wide

4 range of health effects including stronger

5 causal associations between short and long6 term exposure to ozone and newer endpoints

7 such as the effects of central nervous system,

8 cardiovascular system, reproductive and

9 developmental effects. Thank you.

10 DR. SAMET: Okay, thank you. Just

11 a point of clarification. When you referred

12 to the National Academy of Sciences and

13 concern, were you referring to the review of

14 the IRIS formaldehyde document?

15 DR. ERRAGUNTLA: In general, yes,

16 the methodology of EPA, yes.

17 DR. SAMET: I just wanted to be

18 clear because I was Chair of that committee

19 that the review done, and I think several

20 people true on that report was about the IRIS

21 process and not EPA reviews of evidence

22 generally. So I just wanted to make that
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1 clear.

2 DR. ERRAGUNTLA: Yes, that is

3 right. It was in general of the EPA's

4 methodology.

5 DR. SAMET: Okay, other questions,

6 comments? Okay, thank you. Then we'll move

7 on to our next commenter, Roger McClellan from

8 Toxicology and Human Health Risk Analysis.

9 Roger?

10 DR. McCLELLAN: Good day. I'm

11 Roger McClellan, the independent consultant in

12 air quality issues. It's a pleasure to again

13 address the CASAC panel. I appreciate the

14 importance of your public service and the hard

15 work that is involved, having personally

16 served as Chair of CASAC and on numerous CASAC

17 panels.

18 The challenges you face today are

19 substantial as a result of the major

20 improvements in air quality that have been

21 achieved over the last four decades and the

22 increasingly narrow margin between the NAAQS

Page 111

1 and ambient background levels. And as you've

2 just learned, EPA has now expressed concern

3 that every molecule of ozone carries an

4 attendant risk.

5 In the brief time I have available

6 today I want to make six points. First, it's

7 important that you recognize your critical

8 role in reviewing the adequacy of the ISA,

9 involving consideration of exposition of both

10 science and science judgments.

11 I urge you to make certain the ISA

12 clearly relates the science, the process by

13 which judgments are exercised and the

14 resulting judgments.

15 In my opinion, many sections of

16 the ISA do not follow a rigorous process in

17 exercising scientific judgments and

18 documenting how those judgments have been

19 reached. Thus, the resulting judgments are

20 open to question.

21 Two, I urge you to avoid letting

22 any personal preferences for a specific

Page 112

1 standard outcome influence your scientific

2 review. This is especially important since

3 many of you have previously stated your

4 personal policy choice for a more stringent

5 standard for ozone.

6 Three, I urge you to approach your

7 review of the second draft ISA with the same

8 rigor you used in reviewing the first draft. 

9 As an aside, it is my opinion that the ISA

10 authors did not adequately address many of the

11 concerns detailed in your written comments on

12 the first draft.

13 Four, I urge you to focus your

14 attention on the critical pieces of the ISA

15 that will inform review of the four elements

16 of the ozone standard. I urge you in

17 particular to focus on contemporary background

18 ozone levels matched to the averaging time of

19 the NAAQS and secondly, the key adverse health

20 effect endpoints. Not all pieces of this

21 encyclopedic ISA warrant equal attention from

22 you.

Page 113

1 Five, I urge you to focus on

2 whether adverse health effects do or do not

3 occur at ambient levels as described by eight4 hour averaging concentrations and their

5 related statistical distributions.

6 As we now have heard this morning,

7 with a paradigm shift for concern for ozone

8 down to zero, it's important that you really

9 look hard at that issue.

10 If adverse health effects are

11 associated with these ambient ozone profiles,

12 down to zero is then necessary to focus on the

13 nature of the concentration response

14 relationships including your confidence at

15 every level down to zero.

16 The Draft ISA puts excessive

17 reliance on observational epidemiologic

18 studies to describe concentration response

19 relationships without adequately relating the

20 substantial uncertainties at ambient levels

21 and that would say down to zero. These

22 uncertainties must be more clearly described. 
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1 Six, I urge the panel to

2 critically evaluate the adequacy of the ISA

3 for informing policy judgments on both the

4 level and the statistical form of the NAAQS 

5 recognizing these are interrelated decisions. 

6 The present ISA does not

7 adequately describe the spatial and temporal

8 profile of background ozone across the U.S.A. 

9 Major improvements are needed in this portion

10 of the ISA.

11 For any given indicator and

12 averaging time, the level of the standard must

13 be selected in company with the statistical

14 form, and in my opinion, consideration of the

15 relationship of the level and the form, the

16 current background ozone levels.

17 DR. SAMET: Roger, please wind up.

18 DR. McCLELLAN: I encourage you

19 that you recommend major revisions to the ISA

20 including the development of a third draft ISA

21 for review by CASAC and the public.

22 A scientifically credible ISA is

Page 115

1 the foundation for the rest of the ozone

2 standard review process. I feel even more

3 strongly --

4 DR. SAMET: Again, please wind up.

5 DR. McCLELLAN: -- about the need

6 for that third draft in view of the comments

7 I've heard from Lydia Wegman and her staff

8 this morning.

9 Thank you for the opportunity to

10 make these comments. I welcome any

11 suggestions or comments you might have.

12 DR. SAMET: Okay, thank you. 

13 Questions or comments, panel members?

14 Okay, I think just one comment,

15 Roger. If I remember your testimony, I'm

16 sorry, your written comments correctly, you

17 did make one comment about CASAC and proposing

18 more public meetings and I think alluded to

19 teleconferences.

20 I will say I just want to make

21 clear that all our work is done openly. And

22 in terms of teleconferences, any

Page 116

1 teleconferences that we have where we discuss

2 substantive issues are those that are

3 announced and available.

4 I actually could not think of

5 instances where we've had subcommittee

6 meetings by phone, but if we do they would be

7 done according to, you know, procedures, and

8 involve the DFO. So I just wanted to make

9 certain that that's clear.

10 DR. McCLELLAN: Let me ask you

11 this. For a period of time, the last CASAC

12 panel I served on in terms of the PM panel

13 preceding the current PM panel, we had a

14 policy in which up to three individuals from

15 CASAC could communicate with one another, have

16 communications during the development of a

17 draft material. Has that policy changed?

18 DR. SAMET: Let me turn to Vanessa

19 to make comments here.

20 DR. VU: So Roger, we haven't

21 changed the policy that any subgroup of the

22 committee or we call it, panel, can have

Page 117

1 conversation in the presence either by email

2 or a special phone call as they develop the

3 report. So it's a subgroup, whether we

4 actually find three or four.

5 The quorum, we define a quorum is

6 50 percent of the group, so anything less than

7 50 percent is considered subgroup. But I

8 don't recall, Roger, that we actually have any

9 subgroup discussion for the recent review. I

10 mean you can --

11 DR. McCLELLAN: As I said, during

12 the time that I served on the PM panel that

13 policy was in place, and on the advice of

14 General Counsel from EPA the decision was made

15 that if there were three or fewer, i.e.,

16 three, two communicating, they could do so.

17 I think that was a very poor

18 policy. I'm pleased to hear Jon's comments

19 that apparently at the present time you've

20 changed your mode of operation and I

21 appreciate that. I think that's a step in the

22 right direction.
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1 DR. VU: Thank you, Roger.

2 DR. SAMET: Okay, thank you for

3 your comments. And let's move on to our next

4 speaker, Deborah Shprentz, the Consultant to

5 the American Lung Association. Deborah?

6 MS. SHPRENTZ: Thank you for this

7 opportunity. Over the last six years we've

8 seen a number of breakthroughs in the science

9 of ozone air pollution which substantially

10 reinforced the case for strengthening the

11 ozone standard.

12 In particular, there's several new

13 chamber studies or analyses of data from the

14 chamber studies that point to ozone impacts in

15 healthy young adults down to 60 parts per

16 billion or below.

17 And we now have a new study, the

18 Kim et al. study that was specifically

19 designed to measure effects at the 60 part per

20 billion level and found adverse effects

21 including inflammation down to the 60 ppb

22 level.

Page 119

1 There's also stronger evidence

2 with respect to the association between ozone

3 and premature mortality. And the new studies

4 have considered the role of confounding

5 pollutants and found the effects of ozone to

6 be robust. In addition, there are two notable

7 long-term epidemiological studies finding

8 adverse effects of chronic exposure to ozone. 

9 With respect to cardiovascular

10 effects, we find a large new body of research

11 looking at a full range of health endpoints

12 from physiological markers to increased risk

13 of hospital admissions to premature death, and

14 we suggest that EPA reexamine its finding of

15 suggestive of a causal relationship for

16 cardiovascular effects to consider a finding

17 of likely causal.

18 With respect to Chapter 2, the

19 executive summary, we'd like to see the key

20 findings discussed in nontechnical language

21 and plain English, because no reader of this

22 document is going to be expert in all of the

Page 120

1 disciplines covered by this study.

2 Chapter 3 on atmospheric chemistry

3 and ambient concentrations, two points. One,

4 the document needs to discuss the large

5 increase in oil and gas exploitation in the

6 Intermountain West which has led to a concern

7 about ozone concentrations in the winter

8 months and in sparsely populated areas.

9 This is going to be a critical

10 issue for setting the standard with respect to

11 consideration of seasonality, monitor siting

12 requirements, whether the standard needs to be

13 enforced year-round.

14 Secondly, we note that the

15 discussion of PRB seems to have taken on a

16 life of its own. Ozone causes the same

17 adverse health effects regardless of the

18 source of the ozone, natural or manmade,

19 domestic or international. And we point to

20 the National Research Council's 2008 report. 

21 They said defining a PRB is unnecessary for

22 establishing a level above which ozone is

Page 121

1 harmful to health or for estimating changes

2 due to a specific regulatory action. More

3 isn't needed for quantifying human health

4 responses to short-term ozone changes. So we

5 feel that this discussion is more properly

6 placed in the policy assessment document.

7 We really liked the presentation

8 of the integrated health data on short and

9 long-term effects in Chapter 6 and 7. We'd

10 like to see a clarification of the definition

11 of short term and long term. Are we talking

12 about five minutes, eight hours, 24 hours, a

13 week? What does long term mean? Is that

14 seasonal, yearly, over the course of

15 childhood, and so on.

16 But we really like the figures and

17 the tables that provide additional detail in

18 averaging time and concentration level, number

19 of subjects and so on, for the studies that

20 are reviewed both the new studies and the

21 older studies.

22 However, for Chapter 8 on the
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1 susceptible populations, we think that this is

2 a much weaker chapter than then earlier

3 chapters. And we note that the conclusions

4 from recent epidemiological studies are reeled

5 off, but there's no information provided on

6 ozone concentration levels or other pertinent

7 details and the studies are not critically

8 reviewed or placed in context with the studies

9 in the 2006 ISA which led EPA to make strong

10 findings about --

11 DR. SAMET: Please wind up.

12 MS. SHPRENTZ: -- asthmatics as a

13 susceptible population.

14 So in closing I'd like to say

15 Chapter 8 needs a greater discussion about

16 health impacts on children and on neonates,

17 and that this chapter needs to feed into the

18 risk and exposure assessment which should

19 define elderly populations as those 65 and

20 older.

21 DR. SAMET: Again wind up, please,

22 Deborah. Wind up, please, you're past your

Page 123

1 time.

2 MS. SHPRENTZ: Yes. And should

3 also find a way to consider health impacts on

4 children age 0 to 5 which are an important

5 group of susceptibles.

6 DR. SAMET: Okay, thank you. 

7 Let's see, are there questions, comments? 

8 Okay, thank you. Just again a reminder about

9 ground rules. You get a yellow light with one

10 minute remaining. I just want to make sure. 

11 We have a lot of commenters to move through

12 and I want to make sure that the time is used

13 fairly.

14 Okay, next, we're going to move on

15 to William McDonnell, William F. McDonnell

16 Consulting. Bill?

17 DR. McDONNELL: Thank you for this

18 opportunity to make some remarks about a

19 dynamic ozone FEV1 exposure response model

20 that we've recently identified.

21 As you are aware, EPA has usually

22 conducted a risk assessment for FEV1 in

Page 124

1 conjunction with each reconsideration of the

2 NAAQS for ozone. The current risk assessment

3 relies upon a simple five-point concentration

4 response function as its health risk model. 

5 The data underlying the model are

6 from a series of 6.6-hour studies all of which

7 were conducted at a single level of near

8 continuous strenuous exercise using only one

9 FEV1 measure at the end at the end of

10 exposure. Only a small fraction of the

11 population experiences ambient ozone exposure

12 under similar circumstances which limits the

13 applicability of this risk assessment.

14 We have recently identified and

15 evaluated a dynamic exposure response model

16 that allows for the prediction of the temporal

17 pattern of FEV1 response for any pattern of

18 exposure for healthy adults ages 18 to 35

19 years.

20 The coefficients for the model

21 have been estimated from 23 studies with

22 multiple time points over a wide range of

Page 125

1 concentration, ventilation and patterns of

2 exposure, and the data include recovery

3 following cessation of exposure.

4 Should EPA decide to update its

5 FEV1 risk assessment, this model could provide

6 the foundation of a substantially improved

7 health risk model based upon much more data. 

8 The model itself has been described in

9 previous publications.

10 The inputs to the model are the

11 temporal profiles of concentration and minute

12 ventilation over body surface area during the

13 exposure period as well as age and body mass

14 index.

15 The output is the temporal pattern

16 of the population FEV1 response over the

17 entire exposure period. This population

18 response is expressed as the distribution of

19 individual responses for a given exposure or

20 it can be summarized as the mean or the median

21 or other percentiles of responsiveness or as

22 a proportion of individuals who are expected
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1 to experience a change in FEV1 greater than

2 some given magnitude, for example, a ten

3 percent FEV1 decrement.

4 Originally, we estimated the model

5 coefficients from the data for 15 EPA studies

6 with the range of exposures that are given at

7 the bottom of the slide. In order to evaluate

8 the ability of the model to predict responses

9 in independent data we conducted an n-fold

10 cross validation using the EPA dataset.

11 So for each time point for each

12 exposure level of each study we calculated the

13 mean observed FEV1 response, and those are the

14 plotted on the y-axis. And we also calculated

15 the mean predicted response from the model

16 plotted on the x-axis. And we see good

17 agreement between those observed and predicted

18 means on this scatter plot.

19 We next applied this model that

20 was based on the EPA coefficients to mean

21 exposure and response data from seven

22 independent studies from the literature with

Page 127

1 the exposure characteristics given at the

2 bottom of the slide. The mean observed and

3 predicted responses clustered along the line

4 of identity, however, with a small amount of

5 overprediction.

6 Since publication of those

7 previous results, we've obtained individual

8 exposure and response data for seven studies

9 from the University of California at Davis and

10 for the recent low level exposure study from

11 EPA which extended the range of exposure

12 conditions and we combined these data with the

13 original EPA data.

14 We then reestimated the model

15 coefficients and again we found good agreement

16 between the mean observed and the mean

17 predicted responses. And note that these are

18 unpublished data.

19 And then from these same data we

20 also compared the observed proportion of

21 individuals who experienced an FEV1 decrement

22 greater than 10 percent at each time point and

Page 128

1 that's on the y-axis, zero to one. And we

2 calculated the proportion expected from the

3 model and again found good agreement between

4 observed and predicted responses.

5 So I would conclude that we've

6 identified a dynamic model that predicts

7 population FEV1 response for healthy

8 individuals ages 18 to 35 years exposed over

9 a wide range of variable exposure conditions. 

10 This model could serve as the

11 foundation for an improved health risk model

12 in the upcoming EPA risk assessment for ozone,

13 and I recommend some discussion of this model

14 in the ISA for a possible role in the EPA risk

15 assessment for ozone. Thank you.

16 DR. SAMET: Okay, thank you. Let

17 me ask -- Sverre is ready, go ahead.

18 DR. VEDAL: Yes, so I see, you

19 know, the range of concentrations is, you

20 know, extends down to 0.04 ppm. So how do you

21 handle that, the data from say the 0.04 to

22 0.06 range that still looks like it's part of

Page 129

1 this linear concentration response function

2 when there's very little evidence of much

3 going on there from the human clinical

4 studies?

5 DR. McDONNELL: Well, I mean we

6 take the individual data as it is and we've,

7 you know, identified a model form that's

8 basically a differential equation that

9 accumulates dose and allows for recovery. And

10 then we have a sigmoid-shaped relationship

11 between that accumulated dose and FEV1 change

12 and we, you know, fit the model using PROC

13 NLMIXED.

14 I mean this is very nonlinear

15 model, but I'm not sure what else you're

16 getting at there in terms of how we handle the

17 data.

18 DR. VEDAL: Well, I mean it's a

19 very critical part of that concentration

20 response function --

21 DR. McDONNELL: Yes.

22 DR. VEDAL: -- you know, and you're
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1 suggesting we rely on your model. And so, you

2 know, some careful scrutiny of that portion of

3 the curve is needed.

4 DR. McDONNELL: Yes, I mean what

5 we do is we, you know, look very carefully at

6 the observed and the observed versus predicted

7 responses at all of the different exposure,

8 under different exposure scenarios. And, you

9 know, you can only, I mean you can quantify

10 how much difference there is between exposed

11 and predicted.

12 At some point though looking at a

13 given study there's no way to say, well, the

14 model is wrong and this study is right. I

15 mean the study itself is only an approximation

16 of reality.

17 We do have multiple, you know,

18 studies at most of these concentrations so,

19 you know, basically if the model is going

20 through the center of the data one assumes

21 that then, you know, you're getting a pretty

22 accurate prediction.

Page 131

1 DR. BRAIN: I have an adjacent

2 question, again, thinking of the general

3 applicability of the model. I suspect their

4 model is driven by heavy exercise.

5 To what extent does it really, is

6 it predictive at lower levels of exercise or

7 even at rest? And then similarly, I'm

8 concerned about the 18 to 35-year group. 

9 That's a small slice of Americans. What about

10 35 to 100 and what about children and et

11 cetera?

12 DR. McDONNELL: You're right. 

13 Much of the data are from heavy exercise

14 studies. There are a number of two-hour

15 studies at the high concentrations and then

16 the majority of the six and a half hour

17 studies are at 20 liters per minute per meter

18 squared body surface area, about 40 liters a

19 minute on average.

20 There is a six and a half hour

21 study that's done at a somewhat lower level of

22 ventilation in the literature. And then there

Page 132

1 are a couple of unpublished exposures from

2 these new studies that we've gotten that have

3 got lower levels of exercise.

4 We also have some resting exercise

5 studies for two-hour exposures and for six and

6 a half hour exposures. It turns out that in

7 one area that the model does not do very well

8 is at resting exposures at the very high

9 levels of ozone, when you get up to 0.3 and

10 0.4 part per million of ozone. That's a

11 defect in the model somewhere.

12 It turns out not to overpredict in

13 any big way at the much lower concentrations

14 so I'm not sure that that's going to affect,

15 you know, anything relevant to the standard. 

16 And I'm sorry, remind of the

17 second part of the question.

18 DR. BRAIN: The other one was the

19 limited age range in younger and older --

20 DR. McDONNELL: Oh yes, that's the

21 only place we have data.

22 DR. BRAIN: No, I understand the

Page 133

1 reality.

2 DR. McDONNELL: There are plenty

3 of data at older age ranges, and I think that

4 we basically are seeing what appears to be an

5 almost linear decrease in responsiveness with

6 increasing age between the ages of 18 and 35. 

7 You know, it's obviously not

8 linear to age 50 or 60 because you show an

9 improvement in FEV1, but I think one could fit

10 if one took additional data at the higher

11 ages, one could probably fit a curve that

12 would fit that.

13 When you get down below 18 all

14 bets are off. You know, we know something

15 about what happens in 8 to 11-year-old

16 children from a couple of studies at very low

17 levels of ozone, but we don't know much at all

18 between, you know, you've got this increasing

19 responsiveness curve going down to age 18 and

20 8 to 11-year-olds are here. You know, do you

21 go up and down, is it a plateau? There's just

22 no data to really support going below 18.
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1 DR. FOSTER: Bill, that was nice

2 presentation. Just one question and it goes

3 back to the fact that America is a polyglot

4 not only of ages but as well as ethnicities.

5 And it's pretty well been accepted

6 that certain ethnicities are more susceptible

7 to ozone particularly if you're using an FEV1

8 metric as an outcome.

9 So body surface area has been

10 shown not to be necessarily the best at the

11 scale to lung volumes, so you're going to have

12 include into your model since we're a polyglot

13 of population mixture, how are you going to

14 handle that or tweak the model?

15 DR. McDONNELL: Right. What we

16 found, body surface area does tend to explain

17 the differences between males and females. So

18 we like that. It took care of one big

19 problem.

20 We don't have any non-white

21 volunteers in these studies. There are a

22 couple of studies that suggest that, you know,

Page 135

1 or one study in particular comparing the

2 responses of blacks and whites and males and

3 females that there wasn't much of a difference

4 when ozone concentration was corrected for

5 body surface area.

6 That's a single study and, you

7 know, I don't know what we do with, there's no

8 evidence to suggest that there are differences

9 but I don't think there's enough evidence to

10 say there's not either.

11 DR. SAMET: We have two very quick

12 questions from my left here.

13 DR. GRAHAM: I'm thinking about

14 the advice of the NORC on how EPA should use

15 models in decision making and a few questions

16 pertinent to that and they're easy. Is your

17 model proprietary or is it totally open?

18 DR. McDONNELL: Oh, it's totally

19 open.

20 DR. GRAHAM: Okay, that's good. 

21 In terms of the peer review, I mean I know it

22 was in journals. Was there an in-depth peer

Page 136

1 review of the model structure itself and the

2 algorithms or was it superficial?

3 DR. McDONNELL: I would say it was

4 pretty superficial. I mean I think, you know, 

5 John Langstaff from EPA has actually taken

6 this model though and the EPA dataset and he's

7 been able to pretty much reproduce what we've

8 done with the EPA dataset.

9 The additional data that I've

10 gotten, you know, was given to me with the

11 idea that I can't release that. So the EPA

12 would have to get those data from the original

13 authors but, you know, that's possibly doable. 

14 I hope so.

15 DR. SAMET: Fred?

16 DR. MILLER: I guess don't kill

17 the messenger. OAQPS is using the chamber

18 studies in their risk assessment and you're

19 presenting a model that's much improved and a

20 much broader extension of being able to

21 facilitate the kinds of assessments that they

22 do.

Page 137

1 And so I commend you for the fact

2 that you're within a given species you can

3 look at CþV dot EþT and do all the things you

4 do. If you were going between species you and

5 I would have some problem, but that's not the

6 issue here.

7 What I want to reinforce though is

8 to what extent, or ask the question, of EPA

9 using in terms of your assessment, if this

10 model is not discussed here in the ISA,

11 because to me it fits very logically in the

12 discussion in 5.2.2.7, and I will be

13 recommending that in my after-meeting

14 comments.

15 But I want to get a feedback from

16 not necessarily you, but EPA's or if someone

17 can say there's not a problem using this.

18 DR. SAMET: Actually I think this

19 is probably not a comment for Bill to answer

20 but one for you to hold for when we have the

21 right people up here.

22 Jim, did you have a question? 
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1 Yes.

2 DR. ULTMAN: Good morning, Bill. 

3 It's good to see you again. I had a similar

4 question that was brought up regarding age

5 regarding obesity, because so much of the

6 population in the United States we're being

7 told continuously is obese.

8 I'm wondering what was the range

9 of the BMIs that you used in your models? 

10 What was the --

11 DR. McDONNELL: And I'm sorry that

12 I don't know that. These though were all

13 generally pretty fit people. I mean we didn't

14 have anybody that was really, really thin or

15 anyone that was obese. So this is going to be

16 within, you know, a fairly normal range of,

17 you know, people sitting around this table,

18 people that could do exercise on a treadmill

19 and that sort of thing for the most part.

20 DR. ULTMAN: What about the

21 sensitivity of the model to the BMI? How

22 sensitive is it to BMI?

Page 139

1 DR. McDONNELL: BMI is a

2 relatively strong effect but it explains very

3 little of the variability and the same for age

4 too. There's a fairly strong relationship

5 between age and FEV1 response. It just

6 neither of those variables explain much of the

7 variability but it's pretty sensitive.

8 DR. BRAIN: In mice, fat mice are

9 more responsive to ozone than skinny ones. 

10 Obesity per se seems to be a risk factor for

11 responsiveness.

12 MALE PARTICIPANT: That's in mice.

13 (Simultaneous speaking.)

14 DR. SAMET: Young mice or old

15 mice. Okay, thank you for your presentation,

16 Bill. And I think what we should do is, we're

17 ten minutes behind but let's stick to a 15-

18 minute break. So that gets us back here at 5

19 of, so let's go on break now.

20 (Whereupon, the foregoing matter

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

22 at 10:56 a.m.)

Page 140

1 DR. SAMET: Okay, we're going to

2 continue with the public comment period. Our

3 next speaker is Christopher Emery from ENVIRON

4 International Corporation. Please go ahead.

5 MR. EMERY: Hi. Thanks for the

6 opportunity to speak to the panel today. My

7 name is Chris Emery. I develop and apply

8 regional air quality models, particularly

9 CAMx, but I'm also experienced with CMAQ, and

10 today I'm going to be talking about the

11 uncertainties related to the estimates of

12 background ozone.

13 The EPA up to this point has been

14 relying on GEOS-Chem to model the North

15 American Background ozone and recent high

16 resolution versions of that model are

17 predicting higher background levels than the

18 low resolution versions.

19 But while the seasonal means and

20 the unpaired frequencies of the model are

21 replicating measurements across the U.S.

22 pretty well, ozone levels of 060 ppb continue

Page 141

1 to be underpredicted and time period

2 comparisons tend to exhibit low correlations. 

3 Observational research has

4 suggested more natural short-term variability

5 with higher background levels exceeding 50 ppb

6 and more evidence of stratospheric intrusions

7 especially during the spring and the winter

8 seasons.

9 ENVIRON has recently completed

10 annual modeling in North America using the

11 CAMx and CMAQ regional models at 12

12 kilometers, and we've been using GEOS-Chem to

13 provide the boundary conditions. Our regional

14 modeling shows improved performance for time

15 period comparisons with measurements

16 especially at the upper end of the frequency

17 distribution as well as higher background

18 ozone.

19 Together with the results of Zhang

20 and colleagues, our analyses have demonstrated

21 that the simulated background levels are

22 strongly influenced by model resolution, so
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1 it's a source of first-order uncertainty. 

2 Furthermore, we want to stress

3 that higher temporal resolution needs to

4 accompany the higher spatial resolution. One5 hour meteorological frequency used in the

6 regional models is superior to the six-hourly

7 frequency used in global models.

8 Background estimates from the

9 global and the regional models are increasing

10 to converge and they're leading to higher PRB

11 levels or background levels in a more credible

12 way but we're far from reaching a point of

13 diminishing returns.

14 Further refinement is limited by

15 sources of higher order uncertainties and

16 today I'm going to discuss some of those that

17 we need to address. Certainly these models

18 must have certain attributes in order to close

19 to an improved characterization of background

20 ozone.

21 First, vertical resolution can't

22 be overlooked. We've been harping on

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1 horizontal resolution for quite awhile, but

2 what we're seeing is that our modeling has

3 demonstrated a need for high vertical

4 resolution in the upper atmosphere

5 particularly to treat the dynamics of

6 tropopause folding events.

7 Additionally, higher resolution

8 reduces numerical diffusion of the large

9 stratospheric ozone gradient that ends up

10 getting into the troposphere.

11 The vertical transport algorithms

12 in both CAMx and CMAQ have recently been

13 updated to dramatically reduce numerical

14 diffusion, but our modeling shows that it's

15 still a problem when you address the upper

16 troposphere and the stratosphere with just a

17 few layers, and that's typically what's done. 

18 Second, stratospheric ozone in

19 regional models are entirely defined by

20 lateral boundary conditions and that's a

21 problem because you have to rely entirely on

22 another model providing some definition of the

Page 144

1 stratosphere.

2 We think that this problem can be

3 mitigated by explicit top boundary conditions

4 in these models from the global models and

5 employing better vertical resolution.

6 Third, wildfires and lightning NOx

7 are two natural sources that are significant

8 now we see to background ozone. Fires have

9 had an insufficient effect in GEOS-Chem

10 because they're not well resolved in space and

11 time and they don't include all the VOC

12 chemistry.

13 The regional models do a better

14 job with the associated chemistry and the

15 resolution but they simply inject emissions

16 vertically according to highly parameterized

17 profiles.

18 Beyond the obvious uncertainties

19 in emission estimates, the models themselves

20 don't account for fire convection or smoke

21 shading and we think that's leading to some

22 overpredictions from the fires.

Page 145

1 Lightning NOx is based on simple

2 parameterizations usually keyed to some

3 evidence for convective activity and then NOx

4 yields are usually constrained by some

5 climatological estimate. Refinements should

6 involve reconciliation with event-specific

7 data from lightning networks or other sources. 

8 Also meteorological model outputs

9 have limited information on convection and

10 typically they overpredict lightning or at

11 least convective activity throughout the U.S.

12 So if that information is used in the regional

13 models, we need to be careful that the

14 lightning NOx estimates aren't overly

15 influenced by these overpredicted convective

16 activities. Convection also has a

17 ramification for vertical ozone exchange

18 within the troposphere as well.

19 So I just want to remind the panel

20 that focused process-oriented analyses can

21 help answer several questions. First, how

22 well does the modeling represent each process? 
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1 How well does the model reproduce natural

2 ozone events according to conceptual models

3 based on observations? And how do the largest

4 model uncertainties each impact ozone,

5 background and source attribution estimates? 

6 And I thank you.

7 DR. SAMET: Okay, thank you. 

8 Questions or comments? Fred?

9 DR. MILLER: I appreciate your

10 comments, but are you saying that the ISA

11 doesn't treat these topics enough at this

12 point or what's the bottom line of your

13 presentation today?

14 MR. EMERY: I think the ISA needs

15 to expand the background ozone estimates, the

16 model ozone estimates to include regional

17 modeling at the finer resolution and beyond

18 that include some of the recommendations I'm

19 talking about. Just don't go with the status

20 quo with the standard model resolutions. 

21 Increase model resolution especially at where

22 stratospheric influences play a role.

Page 147

1 DR. SAMET: Okay, thank you. Our

2 next commenter or our next speaker is Richard

3 Smith from the University of North Carolina at

4 Chapel Hill. Richard?

5 DR. SMITH: Okay, thank you. 

6 Richard Smith, professor of statistics and

7 biostatistics, University of North Carolina. 

8 I'm also appearing today as a consultant to

9 the American Petroleum Institute. I'd like to

10 emphasize that the comments I make are my own

11 comments. They're not the official policy of

12 either UNC or API.

13 My discussion concerns the recent

14 paper by Kim et al. that's already been

15 referred to several times. This is the most

16 recent paper on an ozone chamber experiment,

17 59 subjects exposed to 0.06 ppm ozone for 6.6

18 hours. There were also some experiments at

19 0.08 ppm.

20 As reported by Kim et al. there

21 were a number of response measures mentioned

22 but specifically about the FEV1 decrement in

Page 148

1 ozone exposure compared with clean air. They

2 reported a mean detriment of 1.7 percent which

3 was statistically significant at 0.05, though

4 well short of the level of about ten percent

5 or so that's usually considered medically

6 significant. And this discussion is based on

7 and looking again at the data that were kindly

8 provided by Dr. Kim.

9 So I'm going to make three

10 statistical points. The first of these

11 concerns outliers in the data and the fact

12 that the data do not very well follow a normal

13 distribution.

14 If we look at the histogram, this

15 is just the basic experiment, the 6.6 hours,

16 0.6. The histogram and the superimposed

17 normal curve with the same mean and standard

18 deviation, you can see that the histogram is

19 considerably more peaked in the middle and

20 there are outliers at both ends of the data. 

21 So from that I conclude the normal

22 distribution methods are not particularly

Page 149

1 appropriate. One comment that I would make is

2 I don't feel it's appropriate to overinterpret

3 individual outliers. For instance, there was

4 one individual in the clean air dataset who

5 showed a 17 percent FEV1 decrement, and it

6 seems to me you can only account for that as

7 experimental noise rather than anything of

8 medical significance.

9 So at least my view is that

10 statistical procedures should essentially be

11 looking to be robust against those sort of

12 outliers, and one approach to that is to take

13 a bootstrap approach which makes no assumption

14 about the form of the distribution and, in

15 fact, when the confidence intervals and p16 values are directly compared with those

17 published by Kim they are fairly comparable. 

18 The top line of the table, so this

19 doesn't come out very well on this screen, but

20 the top row of the table essentially shows

21 confidence intervals and p-values that are

22 fairly comparable with those published by Kim. 
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1 But my second point is that this

2 is not very consistent across other endpoints. 

3 The dataset also contained intermediate timed

4 results, at three hours 4.6, 5.6 as well as

5 6.6. Some of the subjects were tested at 0.08

6 ppm.

7 There were also for a smaller

8 subset some 18-hour post experiment

9 measurements of FEV1. Several of those

10 results also showed statistically significant

11 changes but there is some contradictions.

12 The three pairs of results I've

13 highlighted in red all show a stronger effect

14 for 0.06 than you see at 0.08. And since that

15 hardly seems to be medically plausible that

16 suggests to me there's more experimental noise

17 that we're not fully taking into account.

18 My first statistical point

19 concerns the possibility of extending the

20 basic comparison using regression analysis. 

21 For this analysis again I took the clean air

22 adjusted FEV1 decrement as the response,

Page 151

1 examined a suite of regresses such as sex,

2 age, height, BSA and the baseline FEV1.

3 The only one of those regresses

4 that turned out to be statistically

5 significant was the baseline FEV1 adjusted for

6 height and this does have a possible

7 susceptible subgroup interpretation. Low FEV1

8 might be some indicator of a prior lung

9 disease.

10 But when you look at the scatter

11 plot there is a regression curve here. But

12 the main point I want to make here is you've

13 got to extrapolate a long way outside the

14 experimental data to get anywhere close to ten

15 percent FEV1 decrement.

16 I mean this is about five standard

17 deviations on the FEV1 scale so it's well

18 outside the range of the data. To make things

19 even more complicated, the corresponding

20 analysis at 0.08 ppm actually showed none of

21 those covariates turned out to be

22 statistically significant which is a bit hard

Page 152

1 to explain as well.

2 So conclusions, the recent paper

3 by Kim et al. contains evidence of a small but

4 statistically significant response to 0.06 ppm

5 ozone at 6.6 hours. However, analysis of the

6 same data at different time points and

7 comparing results at 0.06 and 0.08 ppm ozone

8 still does not show a consistent pattern of

9 responses to find evidence in this dataset for

10 medically significant effects.

11 Even in a susceptible subset of

12 the population requires considerable

13 extrapolation beyond the range of the data of

14 the kind that statisticians interpreting

15 experimental data typically warn against.

16 Thank you very much for the

17 opportunity to make these remarks.

18 DR. SAMET: Okay, thank you. 

19 Comments or questions? Sverre?

20 DR. VEDAL: Yes, just one. I take

21 your point about experimental noise and it's

22 a good one. The issue about, you know, hours

Page 153

1 of time and exposure, I mean the reason

2 they're using 6.6 hours, and experimentalists

3 know this better than I do, is that there's

4 enhanced response with an increased time of

5 exposure. So the value of looking at

6 responses at lower time points are of some

7 interest but putting a lot of weight on it is

8 questionable perhaps.

9 DR. SMITH: Well, I think that's

10 fair enough, and I mean the introduction to

11 the paper makes clear that their primary

12 interest was in the 6.6 hour response.

13 But the point I was just trying to

14 make was that if you actually do look at those

15 intermediate time points you do see some

16 slightly strange results.

17 DR. SAMET: Fred?

18 DR. MILLER: Did you get the data

19 for the 0.08, because it's not reported in the

20 paper, that that study was only at 60ppb. So

21 did you have access to the subjects that also

22 were in other studies is where you were
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1 incorporating into your analysis?

2 DR. SMITH: This is not other

3 studies. It's the same study, but of those 59

4 subjects they were actually divided into two

5 halves and 30 of them were subject to a

6 separate experiment at 0.08.

7 DR. GRAHAM: Do you know, is that

8 published anywhere?

9 DR. SMITH: The only publication

10 I'm aware of is the paper by Kim et al. I

11 think there may be a second paper in

12 preparation but I don't think it has been

13 submitted.

14 DR. SAMET: Okay, any other

15 comments? Okay, thank you.

16 DR. SMITH: Thank you.

17 DR. SAMET: All right, we'll move

18 on to our next speaker, Mark Nicolich from, I

19 guess it's COGIMET. Mark?

20 DR. NICOLICH: Hi, I'm Mark

21 Nicolich. I'm an accredited professional

22 statistician and I'm going to do a little bit

Page 155

1 of "me too" following in on Dr. Smith's

2 analyses.

3 I used the same dataset. I had

4 all the data points. And one of the points

5 that I found interesting was that they ended

6 up analyzing about 15 percent of all the data

7 that were collected.

8 And Dr. Vedal brought up the fact

9 that initially they said they were only going

10 to look at the 6.6 hours, but the reading of

11 the protocol in the general article seemed to

12 indicate that they were going to do a more

13 complex analysis.

14 The analysis they did was

15 essentially a paired t-test, but if you read

16 the protocol, I can read it to you but it's

17 fairly complicated. So I think they initially

18 had planned to analyze all the data.

19 Anyway I analyzed all the data in

20 a parametric way and I analyzed it with a

21 difference between the control and the

22 response and the ratio of the control and

Page 156

1 response. And I also, since it's a repeated

2 measures experiment there are several

3 technical assumptions you can make, and so I

4 ended up analyzing the data five or six ways. 

5 And in my testimony it says

6 exactly what I did, but the idea was that the

7 results were quite different. Statistically

8 significant differences were pretty much

9 dependent upon what model was used and what

10 dependent variable was used.

11 So this gives me pause, because

12 usually with statistical analysis you would

13 like to see some consistency in the results. 

14 So the two points that I would like to make is

15 that to me as a statistician, the reported

16 analysis is somewhat unusual.

17 And of course the other point that

18 several of the other people have talked about

19 is that the decrement, the reported decrement

20 while being statistically significant falls

21 short of having any practical or physical or

22 meaningful difference. Okay.

Page 157

1 DR. SAMET: Okay, questions or

2 comments? Thank you, Mark.

3 Well say, these last two

4 presentations remind me that my colleagues at

5 Hopkins, Mark, well let me just finish, had

6 written an editorial seven years ago on

7 reproducible research. And Roger Payne, one

8 of the authors has a nice piece in Science

9 about a month ago, I think, in the issue on

10 data, describing the benefits of making data

11 available so that it can be analyzed by

12 multiple individuals. And I think it's this

13 reanalysis that can provide us some

14 understanding of how model dependent results 

15 may be.

16 Mike?

17 DR. FOSTER: Just one quick

18 question. There was other outcome variables

19 in the study. Did you do the same statistical

20 evaluation?

21 DR. NICOLICH: I did FEV and FVC,

22 were the two and they were both similar.
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1 DR. FOSTER: I was thinking of

2 biological measurements.

3 DR. NICOLICH: No, I did not. I

4 did not look at those.

5 DR. SAMET: Okay, any other

6 comments? No, from the panel. Okay, thank

7 you.

8 Okay, next we'll move on to Nicole

9 Downey, Earth System Sciences.

10 DR. DOWNEY: Thank you very much

11 for the opportunity to speak to you today.

12 I'm going to talk a little bit about

13 background ozone and a lot of what we have

14 heard, the uncertainties in modeling

15 background ozone.

16 But then I'll move on quickly

17 because that's something everyone is talking

18 about to why I think background ozone is

19 important to consider in the health risk

20 assessment.

21 And so I'll start out by tying

22 this, as an author on two of the most recent

Page 159

1 background ozone papers both the Zhang et al.

2 and the Emery et al., I think that the ISA

3 does a poor job of describing the

4 uncertainties in the sources of background

5 ozone.

6 So there are a few natural

7 sources, these are including the Stratosphere8 Troposphere Exchange which we've all heard

9 about quite a lot, lightning production of

10 NOx, biogenic production of VOCs, wildfires,

11 soil production of NOx, and then there is of

12 course this issue of long range transport of

13 international emissions.

14 And I think for those people that

15 work on these models, these are some of the

16 most uncertain components of the models. We

17 have a lot of natural things that aren't well

18 constrained, also international emissions

19 inventories are highly uncertain.

20 There was a bottom-up inventory by

21 David Streets that when compared with

22 satellite estimated NOx emissions needed to be

Page 160

1 adjusted by a factor of two in order to be

2 consistent with these satellite measurements. 

3 So my point is that the ISA needs

4 to more adequately discuss the sources of

5 background ozone, the uncertainties related to

6 those, and then I'll go on to say that the

7 peak background ozone concentrations are

8 pretty much that I think we can agree

9 underestimated in these models.

10 And the first is that all of these

11 processes are highly parameterized and very

12 average both in time and space. And I think

13 that when you get to refining your estimates

14 in both time and space you can help to match

15 observations but then there are numerical

16 diffusion problems, not even problems, just

17 numerical diffusion within the model that

18 washes out peak ozone signals.

19 So there's really no way to get

20 around that until you start doing sort of

21 plume-in-grid type very large changes in the

22 models.

Page 161

1 And then finally, we've seen from

2 what Dr. Emery presented earlier that there

3 are differences between different models and

4 these models are not converging on a single

5 answer yet. They're not even converging on

6 close to the same answer.

7 We have no idea, for example, what

8 the response from wildfires is. And there's

9 significant research that remains before the

10 models converge on a single answer.

11 My next point is quite different

12 but I think it's very important especially

13 when we consider what EPA was talking about

14 planning. And here I've shown the figure that

15 they have which describes their definition of

16 background and that is that they eliminate all

17 anthropogenic emissions of ozone precursors. 

18 And the Clean Air Act mandates

19 that EPA protects public health with an

20 adequate margin of safety. And so here the

21 assumption is that if you remove all

22 anthropogenic emissions you will maximize the
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1 benefit to public health.

2 We know, however, that

3 anthropogenic emissions have a significant

4 positive public health impact. We can all

5 agree that people are healthier today than

6 they were say in 1700.

7 So there are things that we need. 

8 We need food. We need clean water. We need

9 shelter. We need to be able to maintain that

10 shelter. We need some climate control within

11 that shelter. We need hospitals, doctors and

12 medicine, and we need the public health

13 infrastructure.

14 And so my argument here is that

15 you cannot eliminate background from the

16 health and risk assessment. Instead, you have

17 to include the anthropogenic component because

18 there is a very large public health benefit to

19 some of these processes which generate ozone

20 precursors.

21 People need heat. It generates NOx

22 but they need heat. And this is something

Page 163

1 that we need to weigh. Now that we have been

2 so successful in bringing down ambient ozone

3 concentrations to nearly background levels

4 this is where this needs to go. We need to

5 move on to a more refined estimate.

6 And I think my final point here

7 is, you know, I have this figure, you know, I

8 just took this off of Wikipedia, but it's I

9 think a very good illustration. On the bottom

10 axis you have GDP and on the y-axis you have

11 life expectancy in years. And you can see

12 that there's a huge response in the beginning

13 of the curve.

14 And in the United States in 1840,

15 mean life expectancy was 37 years. Today it's

16 closer to 78. And so these health effects

17 that I'm talking about we've more than doubled

18 life expectancy. This is not a trivial

19 effect. This is a huge effect in terms of

20 public health. And you need to be measuring

21 the public health relative to a background

22 scenario.

Page 164

1 So my recommendation is that we

2 should formulate a new background scenario

3 with broad input that includes the emissions

4 which are necessary for public health.

5 Why do I think this is important? 

6 I think it will change what the background

7 estimates are because ozone chemistry is

8 highly nonlinear, and I think it gets us away

9 from this idea that we can just turn off all

10 anthropogenic emissions nationally or

11 globally.

12 And I think it should be based on

13 reasonable available or best available control

14 technologies which can be deployed over the

15 five-year cycle of the NAAQS with the cost of

16 --

17 DR. SAMET: Please wind up.

18 DR. DOWNEY: -- that change taken

19 into account. Thank you.

20 DR. SAMET: Okay, thank you. 

21 Speaking of heat, we are trying to warm the

22 room up. Comments? Yes, Daniel?

Page 165

1 DR. JACOB: Yes, Nicole, so we

2 heard both from Chris and from you about the

3 problem with the models of reproducing the

4 upper end of the PDFs in ozone and the

5 implications for the background, and that's a

6 very well taken point.

7 And Chris suggested that a road

8 ahead might be to increase the resolution of

9 the models, and you seemed to suggest that

10 there were more intrinsic problems. Maybe it

11 was a structure for Eulerian models and was

12 the variability of sources.

13 And my question for you is at what

14 point do we have to just give up on the whole

15 Eulerian modeling approaches based on bottom16 up knowledge of sources in terms of

17 calculating background ozone that may be

18 relevant to high extremes, at which point do

19 we have to say well, we need some other

20 approach based on analysis of observations, of

21 high events --

22 DR. DOWNEY: Right. No, I agree. 
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1 And I think the first question is, what

2 concentrations are most important for the

3 health effects? How well do the models

4 perform? If they don't perform adequately in

5 that concentration range, it should be based

6 on measurements.

7 And I think NOAA has been doing a

8 great job of making baseline ozone

9 measurements that are really interesting, and

10 I think you'll hear more about that from Sam

11 Oltmans.

12 I would encourage a move towards

13 observations in this forum. I think having a

14 network of sites that have co-located

15 measurements both ozone and CO and other trace

16 gases which would enable you to identify

17 sources would be extremely useful. That's

18 something we don't have.

19 I've spent a lot of time looking

20 at the existing data and it is just really,

21 it's hard to impossible to figure out where

22 the stuff is coming from for measurements

Page 167

1 right now.

2 So I think the models have their

3 issues but the observational network is not up

4 to the task of doing this on a wide spatial

5 scale. But with investment in resources it

6 could.

7 DR. SAMET: Okay, other comments? 

8 Okay, thank you. Next, we're going to move on

9 I guess to dual presenters within five

10 minutes. Julie Goodman and Sonya Sax from

11 Gradient.

12 DR. GOODMAN: Thank you for the

13 opportunity to speak today. Although EPA

14 claims to use the weight of evidence approach

15 in the ISA with consideration of the Bradford

16 Hill aspects and weighing of alternative views

17 on controversial issues, there is no evidence

18 that such an approach was used.

19 There are no clear statements in

20 the ISA indicating how evaluations of the

21 aspects are to be carried out, how judgments

22 are to be made regarding whether aspects are

Page 168

1 considered as being met and how an overall

2 judgment is to be synthesized out of

3 consideration of all of the aspects jointly. 

4 Also, EPA does not weigh alternative views on

5 controversial issues.

6 If EPA were to do this it would

7 consider the view that it may not be ozone but

8 another factor that is causal for the health

9 effects associated with ozone. It would then

10 consider whether this view is less likely to

11 be true than the view that ozone is the causal

12 factor.

13 Many of the issues with ISA's

14 approach are identified in other EPA

15 assessments by a National Research Council

16 committee. These issues included an

17 inconsistent method for evaluating strengths

18 and weaknesses of studies and a lack of a

19 clear framework for evaluating the weight of

20 evidence in establishing causation.

21 Now although the causality

22 framework and some of the intended methods are

Page 169

1 clearly stated at the beginning of the ISA,

2 the same issues noted by the NRC committee are

3 evident in the implementation of the framework

4 and similarly were noted in the First Draft

5 Lead ISA by CASAC.

6 EPA should follow the NRC

7 committee's recommendations in a revision of

8 its weight of evidence approach. To achieve

9 this EPA should consider the hypothesis based

10 weight of evidence approach.

11 As discussed in more detail in our

12 written comments, this approach has been

13 successfully applied in evaluations of

14 potential health effects for several chemicals

15 and was also cited recently by EPA's Office of

16 Chemical Safety and Pollution Prevention in a

17 guidance document for using weight of evidence

18 for the Endocrine Disruptor Screening Program. 

19 So in conclusion, the second draft

20 ISA for ozone does not follow an objective and

21 rigorous weight of evidence approach for

22 evaluating the available data. Thus, the ISA
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1 cannot be relied upon to support a causal

2 relationship between ozone and health outcomes

3 at exposure levels below the current NAAQS. 

4 EPA should follow the NRC

5 committee's recommendations to ensure its goal

6 of providing credible causal conclusions about

7 ozone related health effects in the final ISA.

8 DR. SAX: Thank you. My comments

9 specifically address the evaluation of the

10 controlled human exposure studies, and we

11 already heard from Dr. Smith and Dr. Nicolich

12 on the statistics.

13 And so I'm just going to highlight

14 some of those issues again and reiterate them

15 for your consideration. I really believe that

16 EPA's not interpreting these human exposure

17 studies appropriately and therefore these data

18 should not be relied upon to support a causal

19 relationship between ozone exposure and

20 adverse effects below the current NAAQS.

21 So in Figure 6.1 in the ISA, EPA

22 provides the dose response curve for lung

Page 171

1 function decrements from ozone exposures

2 between 40 and 120ppb based on data from these

3 controlled human exposure studies. And then

4 EPA concludes that there's no evidence of a

5 threshold in this exposure range.

6 But again just because you're

7 fitting a statistical curve does not mean that

8 this is evidence for lack of a threshold. 

9 There is evidence, for example, that

10 antioxidants can counter the ozone effects on

11 lung function and this is consistent with a

12 threshold mode of action, and this data really

13 needs to inform these dose response curves. 

14 In addition, EPA doesn't include

15 any 95 percent confidence interval around each

16 point in this figure, and this would clearly

17 show that there's uncertainty and lack of a

18 statistical significance at exposures of 40

19 and 60ppb.

20 Then further, EPA asserts that the

21 controlled exposure data support an

22 association between 60ppb ozone exposure and

Page 172

1 lung function decrements, but the group mean

2 change in FEV1 at 60ppb was only statistically

3 significant in the study by Kim et al. 2011,

4 and not in others.

5 EPA really needs to give equal

6 weight to all statistical analyses, not only

7 those that show statistically significant

8 results, including methods that incorporate

9 all exposure concentrations and time points

10 such as in a meta-regression.

11 But at any rate, regardless of

12 whether these reported lung function

13 decrements at 60ppb are statistically

14 significant, the important issue is whether

15 they are really adverse and this has come up

16 a lot as we've heard.

17 FEV1 decrements reported at 60ppbs

18 range from 1.7 to 3.5 percent so they're well

19 within the intraday individual variability. 

20 And in addition, these decrements are really

21 transient, reversible and of low severity.

22 So in closing, the results from

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1 human exposure studies really do not support

2 a relationship between ozone exposure and

3 adverse effects below the current NAAQS

4 because these effects do not meet the criteria

5 for clinical adverse effects.

6 In fact, the lowest ozone

7 concentration associated with potential

8 adverse effects is almost 90ppb as reported by

9 Schelegle et al. 2009. Thank you.

10 DR. SAMET: Okay, thank you. 

11 Questions or comments? We'll move on. Our

12 next speaker is Doug Blewitt from Air Quality

13 Resource Management.

14 MR. BLEWITT: Thank you for the

15 opportunity to speak to you today. What I'd

16 like to talk about is we've heard a lot about

17 application of models to determine background

18 and the advancements that have been made. But

19 we haven't really talked very much at all

20 about what do we do with this estimate of

21 background that we're getting.

22 And what I'm going to present to
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1 you today is an alternate approach that should

2 be considered in using background in a risk

3 assessment process. The information I'm going

4 to present was obtained from modeling files

5 obtained from Zhang and both Emery, so we're

6 using their model output as part of these

7 analyses.

8 We used North American Background,

9 alternate definitions would give you different

10 results. The major finding of these studies

11 is when modeled ozone was high background was

12 high. This is very different than what we've

13 seen in the previous modeling studies. And we

14 also have the issue of models are

15 underpredicting the higher end of the

16 frequency distribution.

17 So what I'm presenting here is a

18 comparison between model background and model

19 total ozone to minimize any bias effects

20 between monitoring data and modeling data. 

21 And what we're doing is we're looking at

22 background ozone concentration paired in time

Page 175

1 with total ozone, so we look at background on

2 an episodic basis as opposed to a mean basis. 

3 And I'll show you some results of how that

4 will affect things.

5 This is a plot of, on the left

6 hand side is results from GEOS-Chem and on the

7 right hand side from CAMx. This is for a

8 CASTNET monitoring site in rural Colorado

9 called Gothic. The y-axis is background and

10 the x-axis is total ozone.

11 And what you see in this figure is

12 when you look at background paired with total

13 ozone, background is never less than 50

14 percent of total ozone. That's an interesting

15 finding.

16 And if you look at the total, the

17 upper end of the frequency distribution for

18 this particular site, background is roughly 80

19 to 90 percent of the total ozone.

20 If we extend this approach to an

21 urban site, now this is Denver, Colorado. On

22 the left hand side we have results for both

Page 176

1 GEOS-Chem indicated in red and CAMx indicated

2 in blue.

3 And what you see here is that CAMx

4 is predicting background ozone much higher

5 than total ozone as a result of local sources. 

6 We don't see that in GEOS-Chem because of the

7 large grid size.

8 On the right hand side what we're

9 seeing is comparing the diurnal monthly

10 profile that has been used by EPA in the past,

11 that's the red, versus the hourly paired

12 analysis.

13 And what you see is by using the

14 average we're underestimating the impacts of

15 background at the higher portions of the

16 frequency distribution and over the whole

17 frequency distribution. We've looked at this

18 comparing models to monitored. We see the

19 same trends, but we have more scatter in the

20 data.

21 The next point I'd like to make is

22 the issue of time averaging of the standard. 

Page 177

1 We have a toxicological time frame, we also

2 have an atmospheric time frame.

3 In the past, EPA has not developed

4 rigorous correlations analysis between the

5 risk estimates that are done through APEX

6 versus the eight-hour average of the standard. 

7 And this is an important thing. It was

8 brought up by Roger McClellan this morning. 

9 The last slide I'd like to show is

10 just how important this issue of time

11 averaging is. The upper two slides indicate

12 changes in emissions from 1970 to 2008 for NOx

13 and VOCs. These are nationwide averages.

14 If you look at the bottom graph,

15 the upper portion of that graph is changes in

16 one-hour ozone concentrations and which shows

17 a dramatic decrease. The lower portion of the

18 graph --

19 DR. SAMET: Please wind up.

20 MR. BLEWITT: -- is eight-hour

21 concentrations, we show very little decrease. 

22 Thank you.
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1 DR. SAMET: Okay, thank you. 

2 Questions, comments? Yes, Daniel?

3 DR. JACOB: So with regard to this

4 figure, what is your point? That the ISA

5 doesn't sufficiently discuss long-term trends?

6 MR. BLEWITT: No, the issue is

7 that the risk work has been done on one-hour

8 average concentrations. We have an eight-hour

9 standard. What is the relationship between

10 the one-hour exposure values that have been

11 used for risk and the level of the standard? 

12 That's an important issue.

13 And what we're seeing in this

14 figure is that the peak concentrations long15 term trend are decreasing if we look at it on

16 an hourly basis. The long-term trends of an

17 eight-hour average have very little change. 

18 And what's really going on here is

19 during the morning rise in ozone or the decay

20 in the evening, NOx emission reductions are

21 causing higher ozone from less scavenging and

22 we have a compensating effect. We're raising

Page 179

1 the trough and we're pushing the peak down. 

2 With this form of the standard,

3 compliance is going to be very difficult as

4 you start to approach background levels. So

5 you have this complication of background

6 that's very close to the standard, and now we

7 have this form of the standard with averaging

8 times undefined very well.

9 I mean the ISA needs to be very

10 clear in terms of averaging time. Every place

11 that's referenced in that document should have

12 an averaging time associated with that

13 concentration, because otherwise it's

14 impossible to make comparisons here.

15 DR. SAMET: Okay, other questions

16 or comments? Okay, thank you.

17 MR. BLEWITT: Thank you very much.

18 DR. SAMET: We'll move on to our

19 next speaker, John Jansen, Southern Company.

20 MR. JANSEN: Thank you. I'm John

21 Jansen, Principal Scientist for Southern

22 Company. I'm speaking to you today on behalf

Page 180

1 of the Utility Air Regulatory Group concerning

2 background levels of ozone.

3 The background level of ozone in

4 ambient air is a key question in the review of

5 the National Ambient Air Quality Standards for

6 ozone. Characterization of background air

7 quality affects whether the NAAQS are

8 attainable, which may not be something that

9 EPA can legally consider when deciding whether

10 or how to revise the NAAQS.

11 However, it also affects what if

12 any benefits might be expected as a result of

13 the implementation of any revisions of the

14 NAAQS which is the key issue when deciding

15 whether the revision of the NAAQS is

16 appropriate. I'm going to address two issues

17 related to determining background ozone

18 levels.

19 First, how should it be defined? 

20 EPA previously referred to Policy Relevant

21 Background or PRB, which referred to ozone

22 levels predicted to occur in the United States

Page 181

1 in the absence of North American anthropogenic

2 emissions of ozone precursors, VOCs, NOx and

3 CO.

4 In the second draft of the ISA,

5 EPA now refers to "North American Background"

6 or simply "background." These terms, however,

7 are defined in a way that is essentially

8 indistinguishable from that of PRB, that is,

9 ozone attributable to natural sources

10 everywhere including stratospheric11 tropospheric exchange of ozone and from

12 anthropogenic sources outside of continental

13 North America.

14 This definition of background

15 ozone levels is inappropriate. It zeroes out

16 emissions of ozone precursors in Canada and

17 Mexico as if they could be controlled under

18 the Clean Air Act NAAQS program.

19 EPA's justification for this

20 approach is apparently the Agency's perception

21 that such emissions can be controlled through

22 international agreements with Canada and
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1 Mexico. While it may be theoretically true

2 that the U.S. could enter into a treaty with

3 Canada and Mexico to reduce emissions of ozone

4 precursors, such a treaty would not be part of

5 the Clean Air Act, negotiating and

6 implementing it would not be tied to the

7 deadlines of the Clean Air Act for NAAQS

8 attainment nor would it be likely to require

9 elimination of all emissions of ozone

10 precursors in those countries.

11 Instead, background should be

12 defined as the level of ozone that could be

13 achieved in the U.S. if all anthropogenic

14 emissions of ozone precursors in this country

15 were eliminated.

16 In other words, it would assume

17 current emission rates of ozone precursors

18 outside the United States would continue or

19 perhaps increase, and it would assume

20 continuing natural emissions of ozone

21 precursors worldwide.

22 I should note that applying this

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1 definition may in some cases produce estimates

2 of background ozone levels that are

3 considerably higher than those produced by

4 EPA's unrealistic approach.

5 In work done for EPA by ICF, for

6 example, the summer average maximum daily

7 eight-hour background ozone level in the

8 Northeast was 8.58ppb higher using my

9 definition of background than using EPA's

10 definition.

11 Once this more realistic

12 definition of background ozone is agreed upon,

13 the next question is what the actual

14 background level or levels of ozone are.

15 EPA argues that modeling must be

16 used to determine background ozone levels

17 because even remote monitoring sites are

18 affected by long range transport of

19 anthropogenic sources of ozone within North

20 America.

21 But that should not mean that the

22 data from remote monitoring sites should be

Page 184

1 ignored in favor of predictions produced by

2 chemical transport models, let alone the

3 predictions of a single GEOS-Chem model.

4 As the ISA itself recognizes,

5 chemical transport models including GEOS-Chem

6 have their own uncertainties and inaccuracies. 

7 A recently published paper by Emery and others

8 concluded that wildfires, lightning,

9 Stratospheric-Tropospheric Exchange contribute

10 significantly to uncertainty in modeled

11 predictions of background ozone both when

12 GEOS-Chem was used on its own and when it was

13 used in combination with CAMx model.

14 What should be done then is to

15 derive background concentrations and perhaps

16 a range of plausible background concentrations

17 using predictions produced by a variety of

18 models and using monitoring data as a check of

19 the plausibility of these predictions.

20 I note that this use of model

21 predictions and monitoring data is consistent

22 with the recommendations of McDonald-Buller

Page 185

1 and others in a recent critical review

2 concerning means for establishing background

3 ozone concentrations.

4 Further, background ozone levels

5 must be specified in a manner that is relevant

6 to the NAAQS, which is currently specified as

7 the three-year average of the fourth highest

8 daily maximum eight-hour ozone concentration. 

9 Simply looking at seasonal or even annual

10 average background levels is inadequate.

11 Given the present standard, the

12 relevant averaging period for estimates of

13 background concentrations is eight hours, and

14 the key question is what the contribution of

15 background ozone is to the fourth highest

16 ozone values --

17 DR. SAMET: Please wind up.

18 MR. JANSEN: -- at sites where the

19 value exceeds 75ppb of the standard or other

20 levels that are under consideration. Thank

21 you.

22 DR. SAMET: Okay, thank you. 
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1 Questions or comments? Okay, thank you very

2 much. Next, Samuel Oltmans from the

3 University of Colorado at Boulder.

4 DR. OLTMANS: Thank you. I'm

5 currently a senior research associate at the

6 Cooperative Institute for Research in the

7 Environmental Sciences, a joint

8 NOAA/University of Colorado institute. API

9 provided funding to prepare these remarks. 

10 These are, however, my own views on this

11 topic.

12 A significant portion of my

13 research career has been devoted to measuring

14 and understanding background ozone in the

15 atmosphere.

16 Although North American Background

17 is not a directly measured quantity, I believe

18 it is very important to make measurements of

19 what I will term background ozone not only as

20 a validation tool for models, but also as a

21 quantity that can be directly compared with

22 measurements made at locations that must meet

Page 187

1 air quality compliance requirements.

2 I established the Ozonesonde

3 Program at Trinidad Head, California in 1997,

4 and the Surface Ozone Monitoring Program at

5 this site in 2002 for the express purpose of

6 measuring baseline ozone entering the west

7 coast of the U.S.

8 As I will show, the relatively

9 remote exposed location at Trinidad Head is

10 well located for measuring and understanding

11 background ozone.

12 In the spring, Trinidad Head

13 consistently sees hourly average ozone mixing

14 ratios greater than 50 parts per billion and

15 an April average daytime value of over 45

16 parts per billion and a range of maximum

17 hourly averages between 54 and 65ppb.

18 At the top of the boundary layer

19 at approximately 2 kilometers, average ozone

20 mixing ratios are 50 parts per billion in both

21 the spring and the summer.

22 We've used both trajectories and

Page 188

1 local wind information to determine conditions

2 representative of air coming off the Pacific

3 Ocean. During the daytime hours the ozone

4 measured at Trinidad Head is overwhelmingly

5 representative of the marine background. This

6 is the conclusion of a number of studies in

7 addition to our own.

8 Regular aircraft measurements

9 above Trinidad Head which measure a number of

10 trace species including carbon monoxide in

11 ozone show that air coming onshore has levels

12 of carbon monoxide that are representative of

13 global background at the latitude of the

14 station and implying that we are also

15 measuring the background ozone signal.

16 Ozonesonde measurements as part of

17 CalNex show that ozone measurements at sites

18 running along the coast of California have

19 similar average ozone concentrations to

20 Trinidad Head in the lower troposphere, thus

21 ozone measured at Trinidad Head is generally

22 representative of air entering the coast of California.

Page 189

1 From the CalNex ozonesonde data,

2 when we screen the data below 3 kilometers for

3 possible North American influence there is

4 essentially no difference in ozone amounts

5 from the complete set of measurements.

6 The influence from the

7 stratosphere at lower altitudes is most

8 pronounced at the most southerly site. Asian

9 transport is most prominent at mid10 tropospheric levels.

11 Interior continental locations

12 could also provide useful information on

13 background ozone levels. An example at Denali

14 National Park in Alaska shows that the highest

15 ozone amounts at this remote site are not

16 associated with North American influence but

17 long range transport from Eurasia.

18 Analysis of ozone data from other

19 relatively remote locations along with

20 ancillary constituent data supports the

21 conclusion that ozone observations from such

22 locations are often representative of
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1 background conditions.

2 Recent model results, this is from

3 a model, GFDL, Geophysical Fluid Dynamics

4 model, suggests that background ozone has a

5 greater contribution from upper tropospheric6 lower stratospheric sources than earlier model

7 results. This model has a full stratospheric

8 chemistry.

9 Background ozone makes a

10 substantial contribution to observe ozone at

11 concentrations greater than 50 parts per

12 billion.

13 Air entering the West Coast of the

14 U.S. in the spring has relatively high ozone

15 mixing ratios that appear to be higher than

16 models predict.

17 Intensive ozone observations as

18 part of CalNex confirm that ozone measured at

19 Trinidad Head is representative of air

20 entering the West Coast of the U.S. Biomass

21 burning both in North America and Eurasia can

22 produce significant enhancements in background

Page 191

1 ozone. Recent model results suggest that

2 background ozone has a greater contribution

3 from stratospheric sources.

4 DR. SAMET: Please wind up.

5 DR. OLTMANS: And finally, a

6 broader perspective on background ozone can be

7 provided using observations along with the

8 modeled background ozone.

9 DR. SAMET: Okay, thank you. 

10 Questions or comments? Dan?

11 DR. JACOB: Sam, could you

12 elaborate on what you said, that models tend

13 to underestimate ozone at Trinidad Head,

14 because that has not been my experience.

15 DR. OLTMANS: Yes, at the higher,

16 not on the average but when you look at the

17 distribution of ozone as Nicole pointed out

18 and as you've pointed out, when you get to the

19 higher, you get the dispersion in the model

20 it's not going to show the higher values that

21 you see at that particular site.

22 DR. JACOB: So you're referring to

Page 192

1 the high extremes?

2 DR. OLTMANS: Yes.

3 DR. SAMET: Joe?

4 DR. BRAIN: A question out of

5 ignorance. So there's vertical change in

6 ozone levels, what kind of topography causes

7 mixing? I mean is it, you know, the hills of

8 San Francisco or the Rocky Mountains before

9 Denver? You know, can you make some general

10 statements about conditions that bring --

11 DR. OLTMANS: Well, at Trinidad

12 Head itself, which is in the marine boundary

13 layer, you're mostly looking at ozone that is

14 coming directly on to the coast. When you get

15 inland from California, the ozonesonde

16 observations show that the higher terrain is

17 really intercepting the ozone coming onshore

18 between 1-1/2 and 3 kilometers.

19 DR. BRAIN: So the ground level

20 ozones at Trinidad Head are not always the

21 best predictor of what you might experience as

22 you move east?

Page 193

1 DR. OLTMANS: That's correct.

2 DR. BRAIN: Some of the higher,

3 that's one of your main points?

4 DR. OLTMANS: Yes.

5 DR. SAMET: Okay, thank you. 

6 Next, Allen Lefohn from A.S.L. & Associates.

7 DR. LEFOHN: Thank you very much. 

8 It's good to be here from Montana especially

9 this time of year. Next overhead, please.

10 Why background PRB is important. 

11 Correctly estimating the hourly averages of

12 PRB is important because of human health risk

13 and meeting the standard. Next slide.

14 The stratosphere is an important

15 component. Sufficient evidence exists to

16 illustrate that the stratosphere contributes

17 to PRB ozone at the surface of both high and

18 low elevation sites. The key question is how

19 frequently does STT-S or STE enhance

20 concentrations at these high and low elevation

21 sites? Next overhead, please.

22 Lefohn et al. in 2001 pointed out
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1 that STE processes frequently contribute to

2 hourly average ozone concentrations greater or

3 equal to 50ppb during the winter and spring at

4 high and low elevation sites across southern

5 Canada and northern U.S. STE processes can

6 contribute to violations of the U.S. eight7 hour standard. That's what we published in

8 2001.

9 The recent findings of Langford et

10 al. did document that STE episodes in Colorado

11 resulted in exceedances of the U.S. eight-hour

12 standard during the springtime.

13 Cooper et al. report that

14 descending stratospheric intrusions and Asian

15 pollution plumes play an important influence

16 on ozone concentration distributions along the

17 California coast.

18 Langford et al. report that STT

19 processes enhance surface ozone concentrations

20 at the Crestline, California ozone monitoring

21 site. The site experiences as you know some

22 of the highest ozone exposures in the U.S.

Page 195

1 Recent findings by Emery et al. as

2 reported, results indicate that PRB was well

3 over 60ppb in the West and the Intermountain

4 West due to event-oriented type of activities

5 such as stratospheric intrusion and wildfires. 

6 Ambrose focused on STE and Asian

7 long range transport to the Pacific Northwest

8 and confirmed that these processes were very

9 important.

10 And Lin et al. report that

11 stratospheric contribution in North America

12 background in the spring is larger than that

13 from Asian transport. That was the slide that

14 Sam Oltmans just presented.

15 The frequency of STT-S

16 enhancements, Lefohn et al. published last

17 year investigated the frequency of the

18 processes and their associated enhancements at

19 12 surface ozone monitoring sites in the

20 western and northern tier of the U.S.

21 We concluded that the STT-S

22 contributions were frequent during specific

Page 196

1 months and appeared to enhance the surface

2 ozone concentrations at both high and low

3 elevation monitoring sites.

4 Ludwig et al., using data from

5 radioactive debris injected into the

6 stratosphere during nuclear weapons testing in

7 the 1960s concluded that the stratosphere

8 contributed to ground level ozone

9 concentrations with the maximum occurring in

10 the springtime at both high and low elevation

11 surface monitoring sites.

12 The areas of greatest

13 stratospheric contribution was estimated to be

14 along the eastern slope of the Rocky

15 Mountains, upper Midwest and in a band

16 stretching from Texas into the northeastern

17 U.S.

18 Our current monitoring research

19 program, not monitoring, but our current

20 effort. I'm sorry. The most recent effort

21 looks at 39 ozone monitoring sites. Our

22 results indicate that stratospheric

Page 197

1 contributes to enhanced ozone hourly averaged

2 concentrations greater and equal to 50 at both

3 high and low elevation monitoring sites across

4 many areas in the U.S., and our initial

5 analysis indicates that the spatial pattern

6 generally agreed with the predictions of

7 Ludwig et al.

8 And now these are the locations of

9 the 39 sites across the U.S. Some are

10 CASTNET, some are the EPA AQS. Mount

11 Washington site that was pointed out to us we

12 have used as well as the other sites.

13 This is the number of

14 statistically significant months with ozone

15 enhancements greater and equal to 50. Going

16 from Crestline all the way across to Mount

17 Washington, these are the number of months

18 with statistically significant effects between

19 STT greater and equal to 50 from 2007 to 2009. 

20 The high elevation sites in the

21 west and inter-mountain west experience ozone

22 concentration enhancements frequently
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1 occurring during the spring, summer and fall. 

2 The frequency of STT-S events is greater at

3 higher elevation than at lower elevation sites

4 but both were frequent.

5 Concluding remarks, the

6 stratosphere frequently contributes to North

7 American Background ozone concentrations at

8 the surface of both high and low elevation

9 monitoring sites.

10 And finally, modeling results

11 reported indicate that the background

12 contribution was largest in the 50 to 80ppb

13 range. The GEOS-Chem models appear to

14 underestimate the frequently occurring hourly

15 average PRB ozone concentrations greater and

16 equal to 50. Thank you.

17 DR. SAMET: Okay, thank you. 

18 Questions? Daniel, not surprised.

19 DR. JACOB: Yes. I apologize. 

20 Half of the comments have to do with PRB and

21 that's fair enough.

22 The last point on, what is the

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1 evidence that GEOS-Chem underestimates the

2 background ozone levels at lower, higher than

3 50? I understand 70ppb.

4 DR. LEFOHN: Yes, it's your own

5 data. As we debated in Austin, it's the

6 rotation point of one of the curves that you

7 show in Zhang et al. in the supplemental part. 

8 When one looks very closely it's truly

9 subjective that one can say, I think I see it

10 at 70.

11 And I think during the discussion,

12 Nancy had indicated, Nancy Brown had indicated

13 she thought it was 65. Upon closer look it

14 really looks more like 50 is where there's a

15 rotation. And we presented that in our, that

16 Sam and I did report into the Docket that used

17 your particular thing.

18 In addition, Meiyun Lin presented

19 evidence in a rural model that greater and

20 equal to 50 was an indication. And it seems

21 to fit with, at least our statistical

22 relationship it shows that above 50 we seem to

Page 200

1 have good relationship with STT at some sites

2 during certain times of the year.

3 DR. SAMET: Okay, other comments? 

4 Okay, thank you.

5 DR. LEFOHN: Thank you.

6 DR. SAMET: And heading for our

7 last good-bye, no means the least public

8 commenter, Milan Hazucha from the University

9 of North Carolina at Chapel Hill.

10 DR. HAZUCHA: Thank you. I am

11 Professor Milan Hazucha, the Department of

12 Medicine, School of Medicine and the Center

13 for Environmental Medicine, Asthma and Lung

14 Biology, University of North Carolina Chapel

15 Hill.

16 My research interests include

17 controlled human exposure studies of air

18 pollutants, particularly ozone, PM, sulphur

19 oxides, nitrogen oxides, specifically nitric

20 oxide and carbon monoxide.

21 These comments reflect some of the

22 main points Dr. Allen Lefohn and I submitted

Page 201

1 in written form to the Docket. The views

2 expressed herein are exclusively the authors'

3 and do not represent any official policy of

4 the institutions in which we are employed or

5 any other organization.

6 First point. The use of filtered

7 air may not be an appropriate control exposure

8 because a zero ppb ozone filtered air

9 generated in the laboratory does not exist

10 under ambient or indoor air conditions.

11 We believe that it is important

12 for EPA to discuss in the ISA whether

13 statistically significant effects observed at

14 concentrations below the current standard when

15 compared to filtered air control retain the

16 same statistical significancy if the results

17 were compared to Policy Relevant Background

18 ozone concentrations.

19 The latest research results

20 published in the literature indicate that

21 hourly average concentration greater or equal

22 of 50 parts per billion frequently occur under
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1 PRB conditions at some sites in the U.S. 

2 Thus, comparing ozone responses to an

3 unrealistic filtered air control exposure is

4 misleading.

5 Second, comparing the average

6 changes across corresponding time intervals

7 using either the absolute or relative

8 differences between ozone and filtered air

9 responses and expressing them as quote "ozone10 induced" unquote is misleading.

11 The filtered air responses in such

12 adjustments may substantially quote

13 "artificially" unquote enhance or diminish the

14 magnitude of ozone response. This presents

15 potentially misrepresentation of the results. 

16 In order to correctly interpret

17 what the quote "ozone-induced" unquote effects

18 are, it is necessary to discuss pre- to post19 exposure differences as well.

20 Third, temporal pattern of changes

21 provide important information on intra22 individual variability of response. With

Page 203

1 considerable between and within exposure

2 variability of individual's FEV1, the utility

3 of using only the end exposure FEV1 value for

4 health assessment is inadequate.

5 Fourth, it is unsettling that the

6 Agency has modified its policy on the

7 acceptance of research data for the support of

8 the national standard by accepting non peer9 reviewed material as well. The acceptance of

10 material which is not available for a peer11 reviewed scrutiny casts doubts on the quality

12 of data on which the EPA recommendations and

13 conclusions are based.

14 Fifth, we suggest that the EPA

15 write a section in the ISA that discusses the

16 similarities between human health and

17 vegetation research results.

18 There are a number of important

19 similarities between human health and

20 vegetation research findings in both the

21 mechanisms as well as the pattern of response

22 that should not be ignored. For example,

Page 204

1 ozone effects are cumulative, and two, peak

2 concentrations appear to be more important in

3 eliciting the effects than the averaging of

4 ozone concentrations would suggest.

5 These findings noted by vegetation

6 researchers formed a basis for recommending a

7 cumulative exposure index that provides

8 greater weight to the higher ozone

9 concentration versus the mid-level values.

10 Controlled human laboratory

11 studies have shown that there is a

12 disproportionately greater pulmonary function

13 response from higher hourly average ozone

14 concentrations than from the lower hourly

15 average values. Thus, the efficacy of the

16 current eight-hour standard is reduced by not

17 reflecting adequately the dose response

18 relationship which is not monotonic over an

19 eight-hour period.

20 Six, in September of 2011,

21 President Obama ordered EPA administrator to

22 withdraw the proposed revision to the ambient

Page 205

1 air quality standard for ozone. This provides

2 a unique opportunity to identify alternative

3 forms for the human health standard.

4 The alternative approach such as a

5 cumulative exposure index, may be more

6 appropriate to protect human health than the

7 current form of the standard. Thank you.

8 DR. SAMET: Okay, thank you. 

9 Questions or comments? Yes, Fred?

10 DR. MILLER: Milan, I'm curious at

11 your number two point in your written

12 comments. It's statistically valid to look at

13 the trend for an individual in clean air and

14 then form the difference at what they do in

15 ozone. So I do not accept as a statistician

16 your feeling that this is an inappropriate

17 comparison.

18 It's the only valid way that you

19 can have the fact that you have changes in

20 clean air and you're seeing if the exposure to

21 ozone in fact makes them greater or less. So

22 I have to reject that comment that you make,
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1 unless you're talking about something entirely

2 different.

3 DR. HAZUCHA: No, I agree to some

4 degree. And what I was arguing here that you

5 need some additional information as well. 

6 Suppose as an example, you have a subject who

7 had five percent improvement in FEV1 during

8 air exposure and zero percent change during

9 ozone exposure. By calculating the

10 differences this is presented as minus five

11 percent ozone effect.

12 On the other hand you may have

13 another subject who has zero effect in air and

14 minus five percent that come in the ozone. 

15 That's a gain, minus five percent effects of

16 ozone. And I make a distinction and

17 difference between those two minus five

18 percent differences.

19 And that's why I argue that yes,

20 you can calculate differences but you also

21 need to present the data pre- to post-exposure

22 so one can evaluate better where it comes

Page 207

1 from.

2 DR. MILLER: Okay, and that's why

3 you have 59 subjects in the clinical study

4 that they did, to allow that intersubject

5 variability and the profiles, do you in fact

6 get an overall mean response?

7 One of the things that seems, I

8 don't know how many people have commented

9 relative to the 60 part per billion and the

10 statistically significant but not biologically

11 significant, and yet nobody has bothered to

12 comment on the 42 percent increase in PMNs

13 that occurred, which is highly biologically

14 relevant.

15 Now that doesn't affect your

16 comment. I'm interjecting more. I guess it's

17 close to lunchtime maybe, I don't know.

18 DR. SAMET: Good point. Let's

19 see, other comments, questions for Milan? 

20 Okay, thank you.

21 DR. HAZUCHA: Thank you.

22 DR. SAMET: So this ends the

Page 208

1 public comment period. I want to thank you

2 all for your comments and input both orally

3 and in writing.

4 On the agenda, we're actually up

5 to discussion of EPA charge questions. We're

6 not up to lunch yet. Sit down, Mike.

7 So this is something new that was

8 an opportunity to allow the panel to look

9 across the charge questions that we've been

10 given by the Agency that we've shaped our

11 discussions around, and our letter will be

12 around those, to make certain that something

13 has not been overlooked or forgotten that we

14 want to make certain to talk about while we're

15 here.

16 So clearly the charge questions

17 guide us through the document and touch on all

18 the issues, but there might be points that are

19 neglected for a chapter or perhaps come out of

20 the totality of the document that we need to

21 discuss.

22 So this is really an opportunity

Page 209

1 for the panel to raise such issues and we'll

2 add them to our work. So let me hear if there

3 are comments.

4 Judy?

5 DR. GRAHAM: I put that question

6 on two categories. One category is there's

7 some issues that flow through several of the

8 chapters that I read that could be discussed

9 old versus new as opposed to saying something

10 about it for every chapter. So that might be

11 conservative of our time. There might be

12 other things that cross-cut many chapters.

13 And the other issue is that it,

14 and I'll be honest with you, it pains me to

15 bring it up. But I think that this document

16 has not received sufficient external input and

17 review prior to giving it to CASAC.

18 And I made that comment before. I

19 didn't make it into the microphone, it was in

20 writing, and it was because it was too painful

21 for me to say that because of the respect, and

22 I will add, and the affection that I feel for
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1 a lot of the authors. So this is no

2 disrespect. It is an honest acceptance.

3 I mean I know my limitations, and

4 if I got you a cast of experts in ozone

5 inhalation toxicology there would be more than

6 me sitting here.

7 So I offer this as just a general

8 comment that gives me a lot of concern. And

9 some of the individual specific comments I

10 have I think are a reflection of some of the,

11 you know, classical ozone experts not being

12 included in the review. So those would be my

13 two categories to raise here.

14 DR. SAMET: Well, there's a number

15 of comments. I mean some from panel members

16 and I think actually some from our public

17 commenters about the authorship and so on.

18 If these are general issues that

19 we think should be discussed, the nature of

20 the review, then we should bring them up here. 

21 And I think you're sort of cutting at that. 

22 I mean and then that said of course, there's

Page 211

1 such a limited time period that to begin to

2 add in layers of review becomes very, very

3 difficult.

4 And we are the ultimate peer

5 reviewers here so I think we have to remember

6 that. So that's a process question in part

7 that we might come back to. Others? Anything

8 else?

9 Again, I'll just push this since

10 we haven't done this before and I think we

11 have to feel our way through what is the right

12 kind of thing to bring up here. I see hungry

13 people. Joe?

14 DR. BRAIN: I still would like to

15 see a little more about adaptation which seems

16 to be so important to ozone toxicology. And

17 it seems to me there may be a big difference

18 in the population of our routinely exposed to

19 higher levels of ozone and then a peak might

20 mean much less to them than to a totally naive

21 population.

22 So in terms of really estimating

Page 212

1 risk and how people respond I look for it, and

2 it seems to me that's a topic that's still in

3 my mind deserves a little more attention.

4 DR. SAMET: So we should think

5 about that. And I guess that's one that

6 potentially gets at the quote "at risk"

7 populations or less at risk and so on, but it

8 also would have to draw on the underlying

9 phenomenon, what comes out of the --

10 DR. BRAIN: So population should

11 rarely see ozone and then see a lot of it

12 there at greater risk than people who

13 routinely see it.

14 DR. SAMET: Okay, so we need to

15 tuck that one away to think about. Anything

16 else?

17 DR. MILLER: I'll add to that the

18 aspects of attenuation, because it really

19 bothers me that we talk about attenuation and

20 the pulmonary function changes that you can

21 see in humans repeatedly exposed and you can

22 duplicate it in animals, and yet when you then

Page 213

1 open up the animals while the pulmonary

2 function changes attenuated, the lesions

3 continued to increase.

4 And so attenuation is in my view a

5 false negative. And I don't think there's

6 enough discussion of the net synthesis

7 interpretation of what attenuation impacts are

8 in this document.

9 DR. SAMET: Okay. All right.

10 DR. BRAIN: Maybe related to that,

11 you know, what is the, are we spending too

12 much time worrying about small changes in

13 pulmonary function and not worrying enough

14 about inflammation which has, and remodeling. 

15 Things that are admittedly harder to measure

16 but are probably much more related to real

17 disease, real consequences.

18 DR. SAMET: Okay. Well, we're up

19 to five after which is the official lunchtime. 

20 I'm noting that we're behind because we should

21 have done Charge Question 1, but we had I

22 think a lengthy and valuable discussion with
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1 the public speakers.

2 So we will reconvene at 1:00. I

3 think we have time this afternoon to do our

4 work. So I think lunch for the panel is in

5 the Raleigh Room.

6 (Whereupon, the foregoing matter

7 went off the record at 12:06 p.m. and resumed

8 at 1:02 p.m.)

9

10

11

12

13

14

15

16

17

18

19

20

21

22

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

2 1:02 p.m.

3 DR. SAMET: Okay. We're going to

4 resume. If everybody could take your seats. 

5 Okay. Pretend it's 11:40 a.m., and we're

6 going to start with Atmospheric Chemistry and

7 Ambient Concentrations. And obviously a lot 

8 to discuss on this issue. So Daniel, you're

9 the lead here.

10 DR. JACOB: All right. Thanks,

11 Jon. Yes, there's a lot to discuss. And

12 probably we should spend most of our time

13 discussing those PRB issues, which were the

14 topic of half of the public comments this

15 morning.

16 And some very good points were

17 made this morning. You got my preliminary

18 comments. I have a few pages of scientific

19 issues, which are generally pretty minor.

20 Overall I think the chapter is

21 really very good. Let me focus my remarks on

22 two things. The preliminary comments I made,

Page 216

1 some of the comments have to do with PRB, but

2 most don't.

3 But we should talk mostly about

4 PRB. One issue about that I would like to

5 bring up too, is there's really very little

6 discussion in this chapter on long term trends

7 in ozone. And I think that this is sorely

8 lacking.

9 Analysis of long term trends of

10 ozone in the U.S. is critical if we're going

11 to look at accountability of past emission

12 strategies. If we're going to look at long

13 term influences in background, for example

14 Asian influence and what not. If we're going

15 to look at the effect of climate change on

16 ozone.

17 And it's not like we're lacking

18 literature on the subject. There's a lot of

19 observationally based literature on long term

20 trends in ozone. And that's not reflected in

21 this chapter.

22 But there's a section, 3.6.3 I

Page 217

1 think, on the long term ozone trends, but it

2 basically just cites a few EPA reports and

3 then the Cooper paper. But there's a whole

4 lot more.

5 And in particular, there's a lot

6 of interest in the spatial distribution of the

7 ozone trend. The ozone has been going down in

8 California and the East. Well, what about in

9 the intermountain west. And clearly some

10 discussion of this is needed.

11 Okay. I would like to talk a

12 little bit about this PRB issue, or North

13 American Background, which is Section 3.4 of

14 the chapter.

15 And overall I thought that it was

16 very well written and well balanced, which is

17 not to say that it's perfect. And I made a

18 number of comments on it. And we heard some

19 more comments this morning.

20 I would like to pick on some of

21 the comments made this morning as issues that

22 need some attention in that section. And one
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1 is the inability of current models to

2 reproduce the high extremes of observed ozone

3 concentrations.

4 And this is critical because we

5 need models to quantify background ozone. But

6 we are very interested in the high extremes in

7 terms of relevance to the NAAQS.

8 And then the issue is, well, can

9 you count on models to get the high extremes? 

10 In other words, can you prove models in a way

11 that you will be able to capture the high

12 extremes?

13 And then that gets you into issues

14 of variability of emissions, you know. Or,

15 you know, when we make generalization about

16 emissions from fires, about emissions from

17 lightening and so on. We're not going to

18 capture the high extremes.

19 And then of course the meteorology

20 in our models tend to be always adverse to

21 some extent. I mean, models in general will

22 tend to smooth out extremes in the Eulerian

Page 219

1 models.

2 And so at some point one might

3 need to give up and go to more of an

4 observationally based analysis in order to

5 account for the high extremes in the

6 observations and the contribution from the

7 background. With regard to the different

8 factors contributing to the background in the

9 United States.

10 So we're talking about the

11 stratosphere. We're talking about lightening,

12 fires, intercontinental pollution transport. 

13 All of this was very well treated. I thought

14 that the chapter was a bit uncritical when it

15 comes to the contribution from fires.

16 In particular, it was a given that

17 fires would increase ozone in the west. Well,

18 there's some studies that show that that's not

19 the case. And more, better coverage of the

20 literature could be in order.

21 There's issues about soil

22 emissions of nitrogen oxides in the U.S. Very

Page 220

1 uncertain. The role of agricultural activity

2 may be subtle, maybe it's not clear how will

3 you include this in a specification of a

4 background. Some more discussion of this

5 would be in order.

6 One final point about the

7 background. We've lamented for some time that

8 we only had one model that was providing

9 background estimates. A very good model I

10 should say. But just one model nevertheless.

11 But that's not the case anymore. 

12 We now have a few different papers that are in

13 press at least, and may be on the verge of

14 being published, that have estimates of the

15 ozone background.

16 We heard from Chris Emery about

17 the Environ study. There's also a study by

18 Arlene Fiore at GFDL. I understand that those

19 papers were not in press at the time, whereas

20 the second draft was put together. But maybe

21 they could be included in the next iteration.

22 That's about all really that I

Page 221

1 wanted to say at this point. Maybe Ted and

2 George and David have other points to make.

3 DR. SAMET: I guess, Ted, you're

4 next on the list.

5 DR. RUSSELL: Yes, thank you. 

6 First I want to reiterate some of Daniel's

7 comments, in that I think you should look at,

8 sort of, more varieties of models.

9 And in particular you've got all

10 these new studies that have been done, that

11 are now available using different models. And

12 I think that in the next version you really

13 have to go through those critically to come up

14 with your best estimates, your best approaches

15 to treating the background levels.

16 And in particular I think what,

17 and I think I said this last time, is it would

18 be good to come up with an objective way to

19 treat the model bias and uncertainties before

20 going to the next step of the policy end. You

21 know, how to treat bias is more of a science

22 issue, not a policy issue.
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1 So I think it would be good to

2 have that approach laid out beforehand. I

3 mean, for one that will get away from the

4 issue of it looking like it's, that the

5 approach is to reach a certain end point.

6 So I think, you know, look at the

7 biases in the various models and how you can

8 use the more recent modeling to assess what

9 the bias might be. And also then look at the

10 variability issues.

11 As Daniel and I were talking over

12 lunch. There are a number of things that make

13 it so the models are not going to be as

14 responsive, or show the same range as the

15 observations do.

16 Just because you're using averaged

17 emissions, average, you know, sort of, you're

18 using meteorological models that do not pick

19 up the very small scale, or small in terms of

20 tens of kilometer scale effects of the

21 meteorology.

22 Those are just going to be lost. 

Page 223

1 So you're going to be losing the extremes. 

2 Just have a way to essentially approach that

3 before going to the policy analysis phase.

4 Daniel brought up the idea of long

5 term trends. I think it would be important,

6 you know, what I was sort of hoping to see in

7 this one was looking at sort of frequency

8 distributions of ozone, in terms of the mean,

9 as well as something like a standard deviation

10 or whatever, range over time.

11 Maybe it would be, you know, I

12 could see frequency plots by, you know, 1990,

13 1995, 2000, et cetera. So that you can see

14 how the mean is adjusting to the controls, as

15 well as the distribution. Because you're

16 going to be seeing, and I think I saw a table

17 along these lines, that the lower end is going

18 to start coming up.

19 And I think it has real

20 implications when we start looking at how

21 you're going to develop your quadratic

22 rollback model. And that you're going to have

Page 224

1 to assess how that bottom end is responding to

2 controls just as well as the top end. So I

3 think that should be some focus in the future

4 ISA.

5 You know, one of the things, you

6 look at the number of observations that are

7 below eight hour maximum observations, below

8 40, 40 to 60, et cetera, 60 to 80, greater

9 than 80, just to see how those are responding. 

10 That also brings up the point, is that many of

11 the figures in some of the analysis are for

12 things like the mean eight hour.

13 And I think you really should,

14 almost everything should be focusing, well,

15 maybe not everything, but on your three year

16 average of the fourth highest ozone. 

17 Essentially something equivalent to what

18 you're going to be looking at is the form of

19 the standard.

20 Figure 3-58b looks wrong. I'll

21 just put that out as somehow the area doesn't

22 look like it's still conserving towards one. 

Page 225

1 I could be wrong.

2 You made a comment about the model

3 performance for ozone deposition. Looks good. 

4 You know, it made me wonder how that is. 

5 Because I don't think you're measuring ozone

6 deposition.

7 And the Section 3.9., well, 3.9

8 where it's what's currently being done with

9 the GEOS-Chem modeling of analysis that's

10 underway. I thought that section was weak. 

11 Not nearly so good as --

12 DR. VANDENBERG: Ted, sorry to

13 interrupt. That section is gone, that's what

14 I understand.

15 DR. RUSSELL: Is it gone? Oh,

16 sorry about that. I missed your first part. 

17 Never mind it being weak then. I missed the

18 first part.

19 But I will say just, there's one

20 thing that comes from that that, and I see

21 this all the time, is that there's a tendency

22 to say, this is important, this is important,
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1 this is important. And you have about ten

2 different things that are important. How

3 important?

4 You know, some of those, and given

5 that that section's gone I'm not sure if it's

6 in the other sections. But if you're going to

7 say it's important I want a context of how

8 important it is.

9 Because I don't think some of

10 those things are really that important. But

11 people always say they're important. Because

12 that way it sounds better.

13 And then, I think I said this

14 earlier, do provide some more discussion and

15 analysis of using finer scale models. And

16 what that whole, you know, what going to a

17 finer scale is really going to buy you.

18 Because, you know, at some point I

19 don't think it buys you as much as people like

20 to think it's going to. But it does get you

21 somewhere. But I think you have to be

22 cautious about how much further it gets you.

Page 227

1 And it would be good to actually

2 have an idea of that so if nothing else,

3 people won't keep saying, well if you used a

4 finer scale model. Because I don't think that

5 get's you as much as, that's not really the

6 reason for some of the issue's you're seeing.

7 DR. SAMET: Okay. George.

8 MR. ALLEN: Well, I certainly

9 cannot disagree with Daniel and Ted. Although

10 I'm not a modeler, I agree with that. I also

11 want to join in on the trends bandwagon. They

12 are important.

13 And they're, of course there's

14 different kinds of trends. There's the

15 classic design value trend, you know, the

16 fourth highest, you know, third year average.

17 There's a mean, you know,

18 literally the annual mean or seasonal mean. 

19 There are trends of precursors as well, not

20 just ozone. I think they all fit in.

21 And actually, commenting on the

22 mean, which Ted mentioned. One of the recent

Page 228

1 papers by Zanobetti and Schwartz on ozone

2 mortality actually did use a mean metric

3 because it was a chronic study, not a time

4 series acute study.

5 And so there's an example, to the

6 extent that you accept that study with its

7 limitations, that the mean is potentially a

8 useful metric.

9 So, excuse me, but in many cases,

10 getting back to, I want to call it PRB. But

11 now I'm going to call it NABO. Okay, you

12 heard it here first, North American Background

13 Ozone, NABO, okay. Since PRB is out of style.

14 It would be interesting in some of

15 these assessments that we've heard, to look at

16 those, for that head data and similar area

17 situations.

18 We have, you know, one hour maxes

19 and other metrics. We don't have the so

20 called design value metric, which when you're

21 talking about in a max framework, that to me

22 at least is the most informative.

Page 229

1 And from a science point, sure you

2 want the one hour peaks. You want other

3 metrics. But when you're talking about how it

4 might impact any decision process on the max. 

5 And you can argue whether it should or

6 shouldn't. That's a whole other argument.

7 But there, the classic design

8 value calculation might be more useful. 

9 Excuse me, some general, excuse me, I'm

10 getting over quite a cold here. But I'm no

11 longer infectious. So Ted, you can relax.

12 I really like the revisions to the

13 front of the document. The Executive Summary,

14 the integrated summary, Section 2. And as

15 noted, it does make the bigger picture much 

16 more accessible. And it's not just to the

17 public. It's actually to, at least I'll speak

18 for myself, potentially members of CASAC.

19 Everyone who's read the entire ISA

20 draft from front to finish, please raise their

21 hand. Okay. And Vanessa, I don't think we

22 want to pay us to read the whole thing, except
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1 maybe for Jon. We generally tend to focus in

2 on sections of expertise or of interest.

3 And this up front synthesis has

4 real value to panel members who can't or

5 shouldn't or, you know, read the entire

6 document. Most of us have expertise that is,

7 you know, not just one part of the section.

8 Even though I was assigned Chapter

9 3, you know, I pretend to know something about

10 exposure assessment and that sort of thing. 

11 And it's good to have that. That's a

12 wonderful format. And I hope, personally I

13 hope that can be a model for other ISAs as we

14 go through them.

15 I think we talked about that in

16 the lead review, if I recall right, directly,

17 that same sort of thing. So this is great. 

18 This is really helpful, not just to the

19 public, but to myself as a panel member.

20 Now again, I'm going to focus the

21 rest of my comments on Chapter 3. Overall, I

22 think it's substantially improved over the

Page 231

1 first draft.

2 And, you know, there were a lot of

3 good comments that were incorporated and

4 appear as changes in this revision. Including

5 put a lot of the more detailed material back

6 toward the end.

7 Although I guess there's a little

8 less detail now that Daniel's material has

9 been removed. But that makes it much more

10 readable.

11 And readability is key here. 

12 Because if it's hard to read folks are going

13 either not read it, or just have a hard time

14 reading it.

15 A couple broad, well, comments. 

16 It shows up in here with reference to these

17 high winter ozone and these gas fields in

18 Wyoming. And now in the Uinta Valley in

19 eastern Utah it's the same thing.

20 Now we have the reference of

21 Schnell for the Wyoming Green River Basin. 

22 And I don't think there's any papers out yet

Page 232

1 on the Uinta. But it's the same thing. And

2 they have 140 ppb one hour max in January.

3 And there's probably more of those

4 out there. We just haven't done, you don't,

5 wouldn't normally monitor in those places. 

6 But, so first of all a little sidebar, but I

7 think that's worth, from a, maybe we'll get to

8 that on the pad. But not monitoring network

9 design, that's something to think about.

10 But what's actually interesting

11 though that these are potentially very useful

12 case studies, where you have a very simple

13 scenario.

14 You've knocked out a lot of

15 components that you normally have to worry

16 about. Like, the biogenic component isn't

17 there. Temperature is out of the equation at

18 -10c. It's not a player.

19 You know what your sources are,

20 the precursors. They're pretty well defined. 

21 They're pretty simple. You know, it's just

22 basically the fugitive emissions from the, you

Page 233

1 know, the gas fields. And also the NOx and

2 other emissions from the support vehicles and

3 generators and all that stuff.

4 So I think maybe we could learn

5 more about, in a simplified scenario we might,

6 if you went in and did all the detailed

7 measurements, that I can't do, but others can. 

8 We might actually add to our understanding of

9 how some of these processes interact.

10 Again, it's a simplified scenario. 

11 So there may be a possibility for studies of

12 opportunity there. This is kind of a sidebar. 

13 One thing that might be worth noting is the

14 fracking thing.

15 I know that from listening to the

16 states in the Northeast with the Marcellus

17 Shale. Some of them that are downwind of that

18 are very concerned about what might happen to

19 their ozone concentrations as these things

20 develop in a relatively uncontrolled fashion.

21 You've got the perfect mix. You

22 know, you've got your VOCs. You've got your
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1 NOx from the ground support vehicles and

2 generators.

3 And you go downwind 50 to 100

4 miles from these places, and there's a lot of

5 them. And they're distributed. We could have

6 a whole different ozone, kind of ozone problem

7 that is not even on the radar right now.

8 So I think that to the extent that

9 it's relevant to the discussion of where we

10 are. And I don't even know if there's much

11 literature on that. But if there isn't, there

12 will be. I think that may change the

13 landscape in some.

14 And there's a lot of these shale

15 fields. You know, there's one up in Michigan,

16 there's down in Texas, they've got the

17 Marcellus. There's several of them around the

18 country. It's not just the northeast.

19 And finally, or in general

20 comments. I keep talking about this Canadian

21 smog science assessment. In theory it was

22 supposed to be released last month.

Page 235

1 To the extent that it may be

2 useful to this process, Chapters 3 and 7 are

3 directly relevant to Chapter 3 here. It was

4 peer reviewed, but not in a journal context. 

5 But they did have external review on it.

6 And, you know, it's out there. It

7 may or may not be of interest, or may not be

8 relevant. But if it's not out there now it

9 will be next week, because I'll call them up

10 and say, where is it?

11 All right. I won't talk about I

12 only found two typos, Vanessa. And I spent

13 about --

14 DR. SAMET: Those you don't need

15 to go over.

16 MR. ALLEN: -- ten seconds on each

17 of them. And I won't talk about them. Okay. 

18 Let's see, on Page 3.5 under pre-sources or

19 precursors. You know, this kind of gets back

20 to the trends I was talking about.

21 We have some big changes in heavy

22 duty diesel NOx emissions and controls kicking

Page 236

1 in over the next several years, maybe the next

2 decade.

3 And my concern there is that the

4 inventories, which are in my humble opinion

5 never all that good, might become much more,

6 might become outdated more rapidly as we have

7 these rather abrupt changes in what has been

8 a fairly stable emissions scenario, once you

9 have taken into account VMTs and all that

10 other stuff.

11 But the actual emissions per mile

12 for NOx are going to get kicked way down,

13 almost to zero, as the fleet current controls,

14 as the fleet rolls over.

15 So it's kind of an analogy to the

16 NOx SIP call in 2003 that did have an effect

17 on ozone. The on road source for NOx is a big

18 chunk of the inventory.

19 DR. SAMET: George, I don't want

20 to interrupt, probably just major points if

21 you could.

22 MR. ALLEN: Okay, major points. 

Page 237

1 All right, talked about that. NOy we need

2 more good data on that. But I think BP

3 actually is working that in the context of

4 what would have been the SOx NOx max.

5 We talked about NOx emissions

6 thinning down, but then we have EGU units with

7 CAIR or CSAPR, or your favorite transport rule

8 of the day. That further kicks down NOx.

9 Long terms trends again, the Mount

10 Washington data is out there. And what's even

11 perhaps more important here is that although

12 AIRMAP stopped, that's UNH, stopped in 2010,

13 the New Hampshire State Air Agency picked it

14 up in 2009 and is continuing that trend. And

15 so that could over time become a very valuable

16 long term elevation eastern U.S. trend

17 indicator.

18 On monitoring methods, there's

19 continuing discussion about interference

20 issues for the FEM UV monitor that's used. 

21 The section summarizes those issues well.

22 But taken as a whole, I think
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1 concerns about any positive interferences in

2 that method don't seem to be very relevant in

3 the context of compliance monitoring and

4 calculation of design values. They're fairly

5 limited.

6 And actually, overall, to put it

7 in perspective, the quality of contemporary

8 ambient ozone data are really pretty good,

9 relative to data quality for some of the other

10 NOx pollutants.

11 NO-based chemiluminescence as

12 monitors and FRMs. I think we'll see that as

13 our new FRM. And when we get to the bad

14 winter ozone monitoring sites, this section is

15 limited through 2009.

16 But with the 2011 implementation

17 of NCore and other initiatives, there's

18 probably been a substantial increase in winter

19 ozone monitoring since '09. So it might be

20 worth taking a look at that.

21 I strongly agree with the caution

22 on Page 395 about the issues of approximating

Page 239

1 community scale exposures from what is in

2 reality a relatively sparse, despite our 1200

3 ozone monitor network, sparse relative to the

4 expected urban spatial variability. And I

5 think it's very good to have that in there.

6 We talked about multi-year trends. 

7 The report says it's pretty much --

8 DR. SAMET: So let me ask if

9 there's any other big points?

10 MR. ALLEN: Nope, nope. I can be

11 done.

12 DR. SAMET: Okay, so go big,

13 David.

14 DR. CHOCK: Yes. On the whole I

15 think the chapter is very well written. And

16 Daniel and Ted have already discussed the

17 issues very cogently.

18 And I don't really have too much

19 to comment on. Other than reemphasis of the

20 fact that models tend to under predict extreme

21 values, the upper extreme values. Therefore,

22 we need extreme caution when we are talking

Page 240

1 about the NAB, especially at the fourth

2 highest value in a year.

3 I also have another point to make. 

4 We talk about this Section 3.7.2 talks about

5 the fine scale modeling. We also talk about

6 the model errors being due to lesser

7 emissions, meteorology, et cetera.

8 But there is one important point

9 that almost has never been discussed. Namely,

10 the issue of subgrid chemistry. All CTMs, all

11 chemistry template model assumes uniform

12 chemical reaction within the model agree.

13 But this is true, I mean, but when

14 the time scales of some chemical reactions are

15 short, relative to the mixing time scale, the

16 constituents. Then you don't expect

17 homogeneous distribution within agree. 

18 Therefore, the chemical reactions can create

19 some big problem.

20 For the atmospheric chemical

21 reaction we know that the time scales cover a

22 range of seven order of magnitude. So there

Page 241

1 definitely, there will be errors coming in.

2 And the size of the errors, we

3 don't really know. And this is still a big

4 problem facing chemical modeling. That's all

5 I have to say.

6 DR. SAMET: Okay. So I have some

7 comments. I'll preface them by saying I'm no

8 atmospheric chemist. And my comments are not

9 going to have to do with the details at all.

10 But I really see problems with the

11 chapter as it's constructed. There is no

12 bottom line. And, in fact, isn't this chapter

13 about setting up to identify targets? Targets

14 that will be considered in the REA. And

15 targets that will become critical in the

16 policy analysis.

17 You have two ways to get to those

18 targets, observations, and we've heard about

19 the strengths and limitations of those, and

20 models. And what the chapter should do is lay

21 out, in some sort of framework, what are the

22 tools that should be used moving to the REA
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1 and the policy analysis, and why?

2 And if you read through the

3 chapter, you go through all the details. 

4 There's this model, the GEOS-Chem, whatever,

5 whatever.

6 And I understand there's strengths

7 and limitations in over prediction and under

8 prediction. But what's the decision out of

9 this?

10 What are the tools that should be

11 used? Why? How would you bring together the

12 observations data and the modeling data? How

13 does one cross validate with the other?

14 So I don't see this, I see this

15 chapter as laying out a lot of stuff, but not

16 really coming to the bottom line that is

17 needed.

18 If you look at the in sections,

19 it's sort of unsatisfactory. It's like a long

20 story without an end. So I, and having heard

21 that we're moving to "total ozone risk", it

22 only concerns me more that this chapter is not

Page 243

1 laying the groundwork for actually saying how

2 you get to where you want to be in the REA and

3 policy.

4 So now I'm going to turn back to

5 maybe you and the others to reflect on what

6 I've said. Because I think what you've done

7 is, you've sort of critiqued the scientific

8 methods.

9 But I think this chapter needs to

10 get somewhere. And right now, I'll be blunt,

11 I don't think it's getting, I don't really

12 think it's getting anywhere. So that's just

13 to get you thinking. Kathy.

14 DR. WEATHERS: Yes. I'd like to

15 add to that in thinking about the use of

16 models downstream. So the next step will be

17 fusion of all kinds of models, spatial,

18 temporal models, process models.

19 And I think this chapter could be

20 used to lay out those tools and methodology

21 with an eye toward all the other models that

22 will be combined in this ISA as well. Whether

Page 244

1 it's ecosystem models, whether it's CMAQ

2 model, that will be extrapolated spatially. 

3 So I agree.

4 DR. MILLER: Jon, in view of your

5 comments I have a procedural question. And

6 that is, are you going to ask for each of

7 these chapters, if the people are willing to

8 sign off saying that, if their comments are

9 addressed? Or, you know, are we going to

10 identify chapters that need to come back a

11 third time, et cetera?

12 Because, you know, from the thrust

13 of your questions, and I know that it exists

14 for some other chapters, there's still some

15 major work to be done.

16 DR. SAMET: Okay, I guess you're

17 sort of alluding to the fact that John

18 optimistically, or not optimistically,

19 proposed that there would be a completion of

20 the draft over the next couple of months. And

21 I guess the question that we'll have to come

22 back to is, how important are the gaps that we

Page 245

1 still see, or the needs for change.

2 I would like to hear actually

3 from, perhaps on the atmospheric scientist

4 side, just on my thoughts about this. And I'm

5 obviously thinking sort of what the product is

6 that has to come out of this chapter and

7 whether we're there. And then maybe, Daniel,

8 then you could comment. And perhaps we should

9 hear a little bit from John.

10 DR. JACOB: Well, your comment is

11 interesting. Because it's a question of

12 whether this simply has to be an assessment on

13 the state of the science, or whether it should

14 go into recommendations for good practices

15 going ahead.

16 My understanding was that it was

17 intended to simply provide a critical survey

18 of the state of the science. Now, what you're

19 suggesting is that it should go beyond that.

20 Do the other chapters go beyond

21 that? I'm also a primary reviewer for Chapter

22 10. It doesn't go beyond simply going through
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1 the lay of the land of the science. So I'm

2 interested in your perspective on that.

3 DR. SAMET: So I mean, I would

4 actually, you know, just think about this. I

5 would actually sort of make the analogy to,

6 for example, the bottom line is on the health

7 data and causal influence, which is providing

8 something to move forward on.

9 You know, that for the risk and

10 exposure analysis you move forward with those

11 that are in the, you know, we've had a lot of

12 discussion that are causal, that are likely to

13 be causal.

14 And these are the ones you hone in

15 on. That here there should be perhaps enough

16 explicit guidance that perhaps the choices are

17 clear enough moving forward, that the

18 document, you can turn back and across this

19 whole trail from ISA to REA to policy

20 analysis.

21 It's clear why decisions have been

22 made, why a particular model is used, and how

Page 247

1 it's used. And what the inputs are in the

2 REA. So it seems to me that's what should be,

3 this chapter should be setting up, which at

4 least for me, there should be a more

5 definitive kind of bottom line coming out of

6 the chapter, beyond its survey elements, which

7 it certainly, you know, which it certainly

8 does. So Helen, is that a hand up?

9 DR. SUH: Yes. That was a

10 tentative hand up. But this goes into some

11 comments I was going to say about the next

12 chapter. And I think also just to help put

13 what I think is the ISA.

14 I agree it's really a summary

15 and/or synthesis of what the findings are. 

16 But within there, what I found was lacking in

17 this version, was really the synthesis part.

18 And so, I think, for example,

19 Chapter 4 and maybe Chapter 3, does a good job

20 of summarizing what is known. But the idea of

21 carrying it through to the other sections I

22 think is what's missing.

Page 248

1 And so I think the reason you want

2 that is because it does tie, it does help you

3 come back to the REA and the policy

4 assessment.

5 And when you turn to think about

6 interpreting the results and what do they mean

7 and the weight of evidences. So, for example,

8 like I know from the exposure side, you know,

9 they'll talk about things like exposure air or

10 confounding.

11 But then it's not discussed in the

12 chapters about health. And it's not discussed

13 in the chapters of the summary, in terms of

14 like, well, how does that help you, you know,

15 understand what's going on in the health

16 results?

17 Or how does that even carry

18 through in terms of from the concentration? 

19 What I thought was interesting is that from

20 Chapter 3 to Chapter 4 there was really no

21 tie. And that to me, there should be a tie.

22 Because, you know, Chapter 4 with

Page 249

1 exposures was talking a lot about using

2 ambient concentrations to relate to exposures. 

3 But there really wasn't a tie to, you know,

4 where there could have been a tie, there

5 wasn't a tie to, you know, pertinent parts of

6 Chapter 3. And I think that would have helped

7 make Chapter 4 better, or better synthesis. 

8 So I think that might sort of help with this.

9 DR. SAMET: Yes, Daniel.

10 DR. JACOB: Just with regard to

11 the whole background issue. And I think it's

12 a point that was brought up by John Jansen

13 this morning.

14 There's an important review paper

15 by McDonald-Buller which talks about the state

16 of the science and PRB estimates, and provides

17 recommendations for forging ahead.

18 And, you know, I had a comment

19 about this on the chapter. But clearly that

20 should be brought into the chapter. Because

21 it does provide some, a road ahead as you say.

22 But there's another thing, which I
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1 think is what you touched on, which is that

2 this chapter also needs then to provide better

3 justification for what is being used in the

4 REA and the policy assessment. And that took

5 note of that.

6 DR. SAMET: Clearly this is one of

7 the more critical elements. And, you know, we

8 heard a lot of discussion from the public

9 comment, as we heard before about the

10 complexities here.

11 And I'm just trying to think how

12 this chapter sets up as a foundation for what

13 is to -- Paul or John, this might be a good

14 time if you want to comment.

15 DR. VANDENBERG: Yes, thank you. 

16 These comments are all helpful. And I think

17 they're actually not a big surprise. One of

18 the things that we're doing here, and I think

19 you're all reflecting on that, is this is the

20 foundational information that then serves as

21 the basis for many decisions. And there are

22 a lot in the risk and exposure assessment,

Page 251

1 which you'll review subsequently.

2 So it's a question of what do you

3 put here? What do you put there? And what we

4 have elected to do here is to not draw

5 prescriptive, you know, use this, not that.

6 But we certainly welcome your

7 input on that. If you've got a view that we

8 can feel confident drawing a conclusion about

9 one approach versus another, certainly we

10 welcome that kind of input.

11 But we have, in the first draft

12 and now in this draft, we have tended to shy

13 a little bit away from that, given what I'm

14 hearing here, compared to where we could go in

15 terms of drawing more guidance ultimately for

16 the risk and exposure assessment.

17 As it is now, the anticipation is

18 that in the risk and exposure assessment,

19 you'll see many of those judgments and the

20 basis for the judgments portrayed.

21 You don't have that now, you know. 

22 So that's one of the challenges here. So I

Page 252

1 don't know if that helps. But we certainly

2 seek your comments and suggestions.

3 This does raise the question, as

4 you note, about my optimistic view of this is

5 a second draft moving toward a final document. 

6 And I think that one of the judgments that

7 we're looking for is whether this foundational

8 approach may be going somewhat beyond that, is

9 going to be sufficient.

10 Or whether we need to have yet

11 another draft, which we have not planned for. 

12 But that's, you know, where your input is very

13 helpful to us.

14 DR. SAMET: Now one comment, just

15 in terms of sort of symmetry with many of the

16 other. At least with the components directed

17 towards the other part of the REA, the

18 concentration response and the causal

19 determinations.

20 There are sort of useful bottom

21 line findings coming out of those chapters, in

22 terms of moving forward. I mean, I think at

Page 253

1 the minimum there has to be a far more

2 synthetic discussion at the end of this

3 chapter. I mean, it just doesn't really end. 

4 And I think it has to.

5 I mean, you can, in terms of this

6 process of moving from ISA to REA, you're

7 going to have to decide by precedent, you

8 know, what sort of bottom lines are reached in

9 the ISA versus what goes into the REA.

10 But it seems to me that here

11 you've done an evaluation of this body of

12 concentration data, and then some important

13 tools. And you ought to be able to come to

14 some judgment as to their relative utility in

15 moving forward.

16 And that then is setting up. You

17 know, maybe you're not specifying details in

18 model parameters or whatever. But that there

19 should be something that lays a, I think some

20 sort of foundation, that's a little more, that

21 is more than what is here. But I think I'd

22 like to hear from others on this point. 
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1 Kathy.

2 DR. FREY: Well I think part of

3 the state of the science is merging some of

4 these tools. What's the fusion between again

5 some of the processed based models and

6 empirical studies?

7 And that might be a way to make

8 that shift, by evaluating the state of the

9 science of making those linkages. And that's

10 the integrated part.

11 I think it largely would be used

12 in terms of policy. But it's also used in

13 terms of pushing the science forward. So that

14 may be a way to do it.

15 DR. SAMET: Fred.

16 DR. MILLER: Well, I think this is

17 an area that Dr. McClellan in his written

18 comments, addressed about the need to have

19 this bridge between the science and judgment,

20 not just in the REA and that.

21 And so the question to me comes

22 back, are the air quality people at OAQPS, as

Page 255

1 a collective group, prepared to defend what

2 they do?

3 As opposed to having the experts

4 that are on this panel providing guidance to

5 say, this kind of collectively, from our

6 experience in the field, is the kinds of

7 methods and tools that you ought to be using.

8 And so where at that point do you

9 put the judgment part in? And he's certainly

10 arguing that you do it earlier in the ISA. As

11 has been done for some of the health effects

12 and the other kinds of things.

13 So is it restricted only to the

14 health effects and the atmospheric chemistry? 

15 Is it whatever you come up with? Or does it,

16 in fact, benefit from the pool of experts here

17 providing initial perspective of what are some

18 of the better tools to use?

19 DR. SAMET: Okay. I think the

20 point's made. I just want to see if any of

21 the other -- Ted, do you have a comment here? 

22 He's sort of a CASAC veteran.

Page 256

1 DR. RUSSELL: No, no, I'm not

2 asleep. I got in, I just flew in from

3 Auckland so things are a little off kilter. 

4 But, I mean, it would be different from the

5 prior CASAC reports. I mean, in terms of the

6 form of this chapter, to have somewhat more

7 integrative.

8 I think some of my comments were

9 sort of along those lines, in that I do think

10 it is part of the ISA that you should provide

11 an objective approach to how you deal with

12 biases in the models.

13 And they should provide the

14 information in terms of how to interpret the

15 trends with the idea that, I mean, we know

16 what's coming down the road is they're going

17 to have this quadratic rollback, or some sort

18 of a rollback model. We know that's going to

19 be there.

20 But we don't have the information

21 in this chapter yet to see how the science is

22 going to inform the parameters in those

Page 257

1 models. So I think those should be here.

2 And also I think one of the other

3 things, I forgot to bring it up, that should

4 be here, that I think is going to be

5 important, is how you adjust between various

6 metrics of ozone metrics. And how those long

7 terms trends in those metrics.

8 I do actually, it would be

9 different, but I like the idea that this

10 chapter would be much more prescriptive in how

11 you would inform those pieces of the REA that

12 we know are coming down the pike.

13 And in particular, you know, how

14 you're going to use the model results to

15 define background, whatever that is, to set up

16 the parameters of the rollback model. And how

17 you're going to provide the information to

18 BenMAP and APEX.

19 And those things really aren't

20 here yet. And I think that would be a good

21 part of this. And we have argued for that

22 before.
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1 DR. SAMET: Okay. Thank you. 

2 It's useful to remember that the `I' stands

3 for integrated. So, let's see. Any other

4 comments? John, any further thoughts that you

5 would like to --

6 DR. VANDENBERG: I think that's

7 good for now. I may come back to this later. 

8 Actually, if I could, the one comment was made

9 about some of the newer publications that came

10 out since this draft was created.

11 And in the past CASAC has provided

12 some very specific suggestions about new

13 studies, new models, whatever, that have come

14 out since that draft. That's always very

15 helpful for us if that sort of conclusion is

16 drawn by the group. Because otherwise we tend

17 to view that as an essential element to

18 bringing new studies into the ISA at this

19 point.

20 DR. SAMET: Okay, then moving

21 right along. Chapter 4, Helen.

22 DR. SUH: Okay, so touched a

Page 259

1 little bit about some of the overarching

2 comments. But I might repeat myself, which

3 I'm known to do.

4 So, first of all, I think Chapter

5 4 is a substantial improvement over what had

6 been presented prior. I think it's an

7 improvement both in terms of the clarity of

8 the presentation, and I think on the emphasis

9 on what's important. And also on the

10 presentation of the facts. You know, what is

11 it that we know about ozone exposures? So I

12 think that was a really good job.

13 I also -- harking back to

14 something Judy's always talked about, is

15 really thinking about, talking about what is

16 new since the last review. I think the

17 chapter did a good job with that as well.

18 I think the chapter could benefit

19 -- I mean, I think a lot of the discussion was

20 over short term ozone and it's relationship

21 with, you know, ambient concentrations, and

22 also with other pollutants and co-pollutants.

Page 260

1 And I understand why that is, that

2 emphasis is there. That's what the data is

3 like. The data focuses on 24 hours or maybe

4 an hour.

5 But I think given the standard and

6 given some of the health chapters and emphasis

7 there, I think it would be useful, even in the

8 absence of data, to talk a little bit maybe

9 about what the possible implications are for

10 longer term effects. Or if there are data

11 that could be used, you know, what we might

12 think about in terms of longer term ozone

13 impacts, its relationship to ambient

14 concentrations as well as to other pollutants.

15 So I don't know if that's maybe

16 through maybe some modeling. Taking some,

17 maybe some stuff from APEX. I don't know if

18 that's what it is. Or I don't know if it's

19 trying to request data from -- like, for

20 example, I could give you a lot of the

21 personal exposure data, and you could use, you

22 know, recalculate longer term estimates and

Page 261

1 see how that changes. So I know that wouldn't

2 be peer reviewed. But maybe there's some way

3 to think about that. If not now, then maybe

4 in the REA, and have a place holder here to

5 mention that, just that you're thinking about

6 it. I think that would be great.

7 I think, there are a couple of

8 sections I found somewhat confusing. One was

9 on the simulations using the APEX model and

10 how it's used, basically looking at exposures

11 from just meeting certain design values.

12 I thought that was -- I don't

13 know, that seemed more like belonging to the

14 REA versus belonging to the ISA. I found it

15 misplaced. 

16 And I don't know if it's because

17 of the way it was presented. Because it

18 talked a lot about, you know, those

19 assessments from REAs in the past. And I

20 thought that was, 1) not conventional. That's

21 not typically done in an ISA. 2) I don't even

22 know if that's even considered peer reviewed. 
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Page 262

1 Maybe it is, I don't know. And then 3) that

2 kind of analysis seems not really appropriate

3 for this part.

4 The other section that I found

5 confusing was the section talking about -- I

6 think it's 4.4.3, which is the population

7 proximity to ozone monitors. This was where

8 I thought a great tie in to Chapter 3 could be

9 possible. Because first of all, I think it's

10 not even clear that population proximity to

11 ozone monitors is important, right? Because

12 in urban settings people living near roadways,

13 you're going to see reduced concentrations, as

14 discussed in the other chapter.

15 And then -- so whether or not --

16 and that variation occurs over much smaller

17 distances than the proximity to monitors that

18 you're talking about. So it seems that

19 spatial variability in ozone is much greater

20 than this population proximity that you're

21 talking about.

22 So I think that would be a poor

Page 263

1 surrogate of exposure error, one. But 2) I

2 think you could try to use some data. Maybe

3 overlay the concentration maps that you have

4 in Chapter 3. Overlaying those concentration

5 maps on the population maps with the distance

6 to monitor. And that would be, I think, a

7 good way to tie in the results. Like a little

8 bit of synthesis.

9 And I think then it might, then it

10 would make -- first of all, it would put your

11 discussion more in terms of really what does

12 it mean in terms of concentrations. Which I

13 think is the key.

14 And then 2) I think it would say

15 whether or not it's important. Because, you

16 know, from this I was thinking, oh, I don't

17 think it's important. But I didn't have any

18 data. So it would be good to back it up with

19 data.

20 And so that kind of brings me to

21 the overarching comment which I mentioned

22 earlier. I thought the chapter was good, a

Page 264

1 good presentation of facts. But what I

2 missed, and I don't know if it's in this

3 chapter, and -- I missed a overall summary

4 synthesis, that I thought was going to be in

5 Chapter 2. But it was really -- Chapter 2 to

6 me was just a re-presentation of the summary

7 from each chapter.

8 And what I was looking for was

9 really, well, how does this all fit together? 

10 So why do exposures matter really was missing

11 from, you know, the health effects chapter. 

12 I didn't see, and even, you know, the sections

13 talking about confounding or error. They

14 didn't talk about the exposure results. They

15 talked about epi studies that had those

16 components.

17 But what I think -- you know, even

18 in the long term ozone exposures, there's, you

19 know, there's some big issues related to

20 exposure assessment there, right. And I think

21 those are well recognized big issues. And

22 they were touched upon. But it would be great

Page 265

1 to take what you found in Chapter 3 and bring

2 it forward and bring it backwards, so that we

3 could have a synthesis.

4 Because otherwise, you know, these

5 results are interesting but, you know, why do

6 you really care? So what I think would be

7 good is to try to embed -- you know, and I

8 would argue that the Chapter 2 should be more

9 integration and less summary. I think right

10 now it's almost all summary. And I think in

11 the PM document it was more synthesis and less

12 summary. And I know that we had pushed for

13 that in the PM document.

14 And I would really push for that

15 here, too. Because I liked how you put the,

16 you know, all the up front material up front. 

17 But I missed this, like this more of a

18 complete picture, which I think is really what

19 Chapter 2 should be. So I would argue for

20 that to be put there instead. So that's my

21 overall comments.

22 DR. SAMET: Okay. David.
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1 DR. CHOCK: I think the current

2 version of Chapter 4 is a substantial

3 improvement over the previous version. I like

4 it very much. And I don't have too many

5 issues to add.

6 One small issue is that in Table

7 4-3, you use ratio and slope interchangeably. 

8 And, in fact, I don't think you should do

9 that. Because it depends on the structure of

10 your regression model used in the table.

11 Another point that is a big

12 surprise to me is in subsection 4.5.3, where

13 the chapter describes the children's exposure

14 to Los Angeles and Boston. If both cities

15 were to meet an ozone standard of 74 ppb. And

16 the point is that the 8 hour exposure above 70

17 ppb will be much greater in Boston than in Los

18 Angeles. And clearly this is a result of a

19 rollback, a quadratic rollback I suppose.

20 And I think there is really no

21 justification to show that if it would -- if

22 both cities were to meet 74 ppb standard then

Page 267

1 the Los Angeles children would be much better

2 off. I just don't see the justification of

3 that.

4 And this could expose the problem

5 of the quadratic rollback itself. And also

6 this particular paragraph really has nothing

7 to do with the rest of the chapter. So my

8 recommendation is to have it removed. That's

9 all I have.

10 DR. SAMET: Okay. We don't have

11 comments from Ed. So let me ask if there are

12 others who want to comment on this chapter.

13 Yes, Chris.

14 DR. FREY: Not so much on the

15 Chapter 4, but I mean, maybe to follow up on

16 some of what Helen said about how this ties in

17 to the prefatory, or the front end material.

18 One of the comments I had on the

19 preamble is that, you know, it gives a nice

20 overview of the sort of general methods for

21 the ISA. But I think it fell very short on

22 exposure. 

Page 268

1 And, you know, one of the things

2 that I think could be better connected, and

3 this might have implications for the

4 integrative summary in Chapter 2 as well, is,

5 you know, I guess the source of the hazard

6 identification and the dose response data is

7 a factor influencing the choice of exposure

8 metric.

9 And I think some discussion of

10 that interaction in general in the preamble

11 would be helpful. And then in the integrative

12 summary, something more specific to this

13 integrated science assessment would also be

14 helpful.

15 So, you know, to the extent that

16 some of the studies are based on clinical data

17 of kind of direct measurement of

18 concentration. You know, that's one kind of

19 concentration to the extent some are epi

20 studies based on fixed site area wide

21 monitors. That's a different exposure

22 surrogate. And so I think just carrying that

Page 269

1 through in its implications would have been

2 helpful.

3 DR. SAMET: Judy.

4 DR. GRAHAM: This chapter provides

5 a foundation for exposure being a

6 susceptibility factor or sensitivity or high

7 risk. When we get to Chapter 8, who's at

8 risk, one of the big factors is going to be

9 exposure. And so some of the concepts that

10 are here are very supportive of that. 

11 Discussions of indoor and outdoor, that's

12 great.

13 One thing that didn't come through

14 is what are children's activity patterns by

15 age? So what you're seeing -- and even by

16 time of day. Because what comes up with a

17 kid, a kid is not only more biologically

18 sensitive, in terms of his developing systems.

19 The kid's going to be outdoor in

20 the height of the summer day exercising. So

21 the kid has a triple whammy. And I think

22 that, you know, the scientific foundation
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1 needs to be here so it can be alluded to in

2 Chapter 8.

3 The other point I might bring up

4 is, Page 419 it talks about ozone averting

5 behavior. And that was mentioned earlier on

6 in one of the presentations. And the whole

7 focus is on how people may reduce their

8 exposure. So that would influence epi. It's

9 all, oh, we don't need to worry about those

10 people, you know, they've removed themselves

11 from the exposure.

12 Fine, that's one valid viewpoint. 

13 Another valid endpoint, could it be an effect? 

14 One of the effects of ozone is that you have

15 to alter your behavior to run away from it. 

16 So I don't know the answer to that question. 

17 But it's not obvious.

18 DR. SAMET: Okay. Anything else

19 on Chapter 4? Okay, go on. Chapter 5. Let's

20 see, we have the ultimate trio of ozone

21 dosimetrists here. I was just musing over how

22 many collective years of work you have on this

Page 271

1 issue. You made your fortune on ozone

2 dosimetry. Way to go. 

3 (Laughter.)

4 Jim.

5 DR. ULTMAN: Okay. Chapter 5 --

6 DR. SAMET: I think your mic may

7 have gone off.

8 DR. ULTMAN: I just turned it on. 

9 Okay. Chapter 5 is a combination really of

10 three different things. The uptake in dose of

11 ozone, the reaction of ozone with endogenous

12 substrates once it's absorbed, and then

13 finally how that connects to the method of

14 action of ozone.

15 And I think in the original

16 chapter we criticized a lot the flow of the

17 chapter, from one of these aspects to another. 

18 I think that's been really vastly improved. 

19 And I think most of the other criticisms that

20 we made in the first round were met pretty

21 effectively.

22 There were a few things that I

Page 272

1 personally found that still could use a little

2 bit more work. And what I'll do, I'll mention

3 them kind of broadly. But I have detailed

4 comments where I specifically, in fact, insert

5 sentences and paragraphs that you might

6 consider putting in. Because it wasn't clear

7 to me that you would understand what I meant. 

8 So I made it very specific.

9 But just for purposes now, one of

10 the criticisms was that there wasn't

11 explanation or definitions of some of the

12 dosimetry principles and nomenclature. At

13 least it wasn't very effective.

14 And I think there's been some

15 improvement there. But I think yet there's --

16 still better definition of terms and

17 consistent use of terminology throughout the

18 chapter could still be improved.

19 And also dosimetry principles are

20 mentioned and then results of theoretical

21 simulations and experimental measurements are

22 mentioned. But the two aren't really very

Page 273

1 effectively connected.

2 In other words, how did the -- at

3 least in a qualitative sense, how did the

4 principles lead to these observations or these

5 predictions? I think that could be shored up

6 a little bit.

7 Table 5-1, which I believe was

8 present in the first ISA also, is a comparison

9 of results from different kinds of experiments

10 that have been performed on humans to measure

11 ozone uptake in various regions of the lungs,

12 using various protocols.

13 And this is not an easy

14 undertaking to do it, because these

15 experiments all use different protocols. And

16 even though they all measured ozone dose, they

17 measured them in different ways. And

18 therefore, the doses that they measured meant

19 different things in a sense. And I think the

20 table has all the information there. But I

21 think it's still not crystal clear. But it's

22 not your fault. I mean, it's complicated.
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1 And one of the things I'm going to

2 point you to is a publication in an edited

3 monograph called "Handbook of Human

4 Toxicology" that myself and a colleague had a

5 section in, where there's a nice figure and a

6 table much like yours. You might draw some

7 additional information to help you with your

8 table. The pages in that textbook, I'll give

9 it to you in my comments. But anyway, it's

10 Page 494 to 499 you'll want to look at.

11 The third thing I wanted to

12 mention was that -- we criticized in the first

13 round, on the ISA, the fact that you talked

14 only -- or maybe too much, about the reaction

15 products being at the root cause for the

16 method of action of ozone. And I don't think

17 that's really changed very much.

18 I'm not sure that criticism is

19 important or not, personally. I think it's

20 only important to say that ozone itself, if it

21 gets through to tissue, could cause damage by

22 these means. Or, alternatively, it can form

Page 275

1 toxic products in the ELF and those can be

2 transported further on.

3 So it's not, you know, just as

4 long as you include ozone as one of the

5 possible agents, I think it's fine. But what

6 I did find, and I thought that your coverage

7 was really good.

8 You had reaction mechanisms, you

9 had various different kinds of products. I

10 thought it was very well done, such as it is. 

11 The problem is that there's no prioritization. 

12 I don't know if you can do that or not.

13 But it's like you have a laundry

14 list of these different possibilities. But

15 which one might really be -- you know, which

16 one or ones might really be the most important

17 in creating the mechanism of action that you

18 talk about later in the chapter?

19 And I think if you can connect

20 that better and prioritize, it will help an

21 awful lot. Because otherwise it's just like

22 a list of chemicals. And I thought, as I

Page 276

1 said, coming up with that list wasn't easy. 

2 And trying to support that with the various

3 kinds of mechanisms wasn't easy.

4 But I think you can go, try to go

5 one step further. I don't know if it's

6 possible or not. That's pretty much all I

7 had.

8 DR. SAMET: Okay, Fred.

9 DR. MILLER: Well, I have 12

10 points to make. And part of that's a

11 reflection that Jim is a chemical engineer

12 entered into dosimetry later in life. 

13 Whereas, I sort of was maybe born there.

14 I have to agree with Jim that the

15 chapter is greatly improved. And you've done

16 a much better job of strengthening the mode of

17 action by adding results from animal studies. 

18 And the way the chapter flows. And so I

19 commend you for that.

20 As far as some of the things that

21 can still be improved, I'm going to address

22 some of those. To me there's still a need to

Page 277

1 do some cross-linking. And this may happen

2 also in other chapters. But for example, the

3 section 5.3.7 on Airway Remodeling, there's no

4 discussion there in a link to Section 7.2.3.1,

5 which you discuss in this chapter, the adult

6 primate structural changes, but not anything

7 about the infants and neonates from the

8 primate studies in Davis that have tremendous

9 implication for children. And so I urge you

10 to, if you're not going to add more in just in

11 text, at least do more cross-linking.

12 I -- before you've improved the

13 treatment of the ELF and the acknowledgment of

14 the fact that it could be ozone. But you

15 haven't gone far enough. You went out and got

16 the Bastacky study and he's in John Clements'

17 lab. And John Clements from day one has been

18 interested in the thickness of the surfactant

19 layer.

20 It still comes across here as,

21 well, yes, it's an outside shot. The point

22 is, if you really read that study carefully,
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1 four percent of the surface area is less than

2 .02 microns. The median thickness is .1,

3 which means that 30 to 40 percent are only a

4 few nanometers.

5 So my statements earlier that I

6 brought up at the first round about the

7 possibility for ozone to directly react and

8 get through the epithelial layer is actually

9 improved by what you found here, not

10 decreased.

11 And so this kind of goes to what

12 Jim was saying about you kind of -- still kind

13 of lumped it all together. And so I think if

14 you pulled out some more data from that paper

15 you're going to see. And that also is a very

16 good example of why probably you see the

17 patchy external network of damage with ozone

18 exposures.

19 The difference between the areas

20 where you have very little lining and where

21 you have the more thicker, that probably

22 creates other reaction products. So that's --

Page 279

1 you're on the right track. And it's just, to

2 me, something that needs to be a few more

3 sentences added.

4 Relative to Table 5-1, I have to

5 point out there still is a problem here over

6 and above what Jim talked about. And that is,

7 you are mixing absorption efficiency and

8 absorption fraction.

9 Absorption efficiency is the

10 percent uptake for that amount of material

11 entering a given region. And it is only equal

12 to the absolute fractional uptake for the

13 head. For the other areas, it is not.

14 And you have some examples in your

15 nomenclature in the table where the fractional

16 uptake sums to greater than one. And it's

17 because it's really an uptake efficiency, not

18 a fractional uptake. So you need to clarify

19 that.

20 On 5-8, line 12, you make an

21 excellent point that I think should go forward

22 to the Executive Summary chapter. And this

Page 280

1 has to do with the variability in path link in

2 the trachea. And you point out how you could

3 have a region that might not get a high enough

4 dose. But you have other regions that can

5 within the same animal, or the same human.

6 And that, to me, is a point that

7 should go not only to the summary, but really

8 it is something that has to do with the

9 overall aspects in the population and why you

10 see some people responding more than others,

11 for example.

12 I brought up in the first review

13 the treatment of the Wiester, et al., paper,

14 as it being not included. It still wasn't

15 included. And I will again state, why isn't

16 it? Because -- has the paper been

17 discredited? Because it would require you to

18 change the material on Page 19, where you talk

19 about the ranges. Because Wiester, et al.,

20 they only saw 40 percent total respiratory

21 tract uptake. And you cite others as 50

22 percent and 90 percent and so on. And so the

Page 281

1 paragraph there would need more refinement.

2 And this is again a reflection,

3 just species differences that can occur in the

4 overall uptake. So I'm not going to back off

5 on -- you know, either say it's been

6 discredited or it changes your text.

7 You make a statement on Page 5-9

8 that ozone dosimetry models predict low tissue

9 dose in the trachea. But injuries seen there,

10 and so maybe it's net dose that's better.

11 If that were true, then you would

12 see more effects in the tracheobronchial than

13 you see in the other regions, because that

14 dose is actually very close to what you get at

15 the central acinar region. So that paragraph

16 needs to be reworded. It just doesn't hold.

17 You also talk about the paragraphs

18 on 5-13 where you talk about nasal and oral

19 uptake. And it's probably not biologically

20 significant. I have a problem with that. And

21 you cite where there's probably not much

22 differences.
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1 But to me the definitive study for

2 that is one that Jim Ultman was involved in,

3 the Nodelman and Ultman publication. They

4 looked at shallow breathing and the breathing

5 level you would have with exercise.

6 And you see nasal to oral drop of

7 .9 to .8 for shallow breathing. But you see

8 a .4 uptake to .25 for exercise. That ends up

9 being a 40 percent change in dose. And so it

10 is not correct to say that nasal and oral

11 basically are the same and don't impart a

12 difference.

13 On page 5-50 you talk about the

14 definitive study on FEV1 hasn't been done. 

15 And I'm getting awfully tired of hearing about

16 FEV1 and ignoring -- not, you know, from some

17 of the commenters -- the things about other

18 biological endpoints.

19 Well, yes, you state that the

20 definitive study hasn't been done. And that's

21 true. But the reason it hasn't been done is,

22 for the selection of the subjects -- and I

Page 283

1 pointed this out before, and you have some

2 wording in here that Overton, et al., and of

3 course I'm one of the et al.'s, pointed out

4 how if the conducting airway volume is the

5 controller of that delivered dose, and if you

6 measured that conducting airway volume on

7 every subject that you studied, you would be

8 able to do a much greater normalization and

9 sort out this variability in FEV1 in that.

10 So you allude to it, but it really

11 is a key point for understanding why we get so

12 bogged down in where we see these differences,

13 and so forth, in the variability of it. It is

14 the major player.

15 In the introductory paragraph on

16 5-68 you say that the extrapolation is going

17 to be qualitative. And it could easily be

18 quantitative. And I have to argue that if you

19 would take panel C of figure 9-6 of one of my

20 papers in 1988, where we actually solve for

21 the different species in the broncho lavage

22 fluid protein, got the tissue dose, normalized

Page 284

1 it to body rate in that, and we see you have

2 this plot normalization across species. And

3 you could even now add on the human data. 

4 And the reason is not to bring it

5 up to say you're going to do qualitative or

6 quantitative extrapolation. The point is of

7 that exercise is that it shows the importance

8 of the animal results for underpinning the

9 implications for humans.

10 And throughout it would dispel

11 this "so what" attempt to say, well, changes

12 in humans are not of concern, because, you

13 know, we're talking about 1.7 percent FEV1,

14 and if I do a different statistical model it's

15 1.2.

16 And that's fine, and that doesn't 

17 mean much. But, you know, 40 percent change

18 in pmms, that does mean something. You'd

19 start to see how this massive amount of animal

20 toxicology data shows that we are not that far

21 off being able to integrate the different

22 things.

Page 285

1 So I would take just one endpoint. 

2 And that one's already been done for you. All

3 you got to do is extract the figure -- would

4 show how this is really a homology and

5 qualitative, beyond qualitative can be

6 quantitatively.

7 And the last point that I want to

8 make is I want to re-emphasize that Section

9 5.2.7.7, which is on physical limitations,

10 could be increased in strength in two areas by

11 adding more of the discussion of the exercise,

12 which you don't. You talk about body mass

13 index and some things. In addition, the other

14 thing, this is the logical place for

15 introducing some material on the McDonnell

16 model and the FEV1 and the dynamics. Because

17 it's the perfect integration of it.

18 And I guess I would like to see it

19 there because, to me, it is a very strong

20 synthesis of the ability to then look at a

21 variety of exposure regimens.

22 And I'm reminded in the 1990's
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1 when you took Overton and my model and you

2 took people through time and space, a 9-year

3 old and an adult, and you compared it to the

4 monkey in that, and you were able to show the

5 importance of the animal studies, and that

6 there wasn't that much for a margin of safety.

7 And so here you have the McDonnell

8 study where you can really synthesize a number

9 of different human studies and give strength

10 to the OAQPSs using the changes that they see

11 in clinical studies and modeling that for

12 overall risk.

13 So those are my comments. I won't

14 go into the ones that require typing up of --

15 except for please have a technical editor go

16 through and where it should -- you've used

17 which when it should be that. Just my own pet

18 peeve.

19 (Laughter.)

20 DR. SAMET: Judy.

21 DR. GRAHAM: Okay. I think there

22 needs to be more thought given to Chapters 4,

Page 287

1 5 and 6 as a unit. Exposure, dose, response. 

2 And that all eventually gets us to sensitive

3 sub-populations, which is -- the standard will

4 eventually be based upon them.

5 So, for example, the issue of

6 children is raised on like page 5-14. And

7 there have been some studies about influence

8 of age on dosimetry.

9 Well, that's great. I think it

10 got maybe a whole paragraph. Well, kids are

11 what we care about. And the dose is right

12 smack dab in the middle of understanding about

13 kids. So how about a figure that shows the

14 age dependence of dosimetry?

15 I'm looking at Page 5-26 now on

16 mechanisms of action. First of all, thank

17 you. The previous one had more effects than

18 MOA. So you really did a good job of cleaning

19 that up. And I have some picky things, but

20 they're only picky in terms of what didn't get

21 cleaned up in that respect.

22 So my concern is that it be

Page 288

1 clearly understood. And so, for example, we

2 know from the whole of the document that

3 things like concentration, duration of

4 exposure, exercise are very important.

5 And in many cases the MOA studies

6 provide such information. But in some cases,

7 you don't know whether in humans, whether it

8 was exercising or not. In some cases, you

9 don't know whether it was acute or chronic.

10 So I'm not talking about five

11 hours a day, five days a week, for two weeks. 

12 I'm talking about -- you can use general

13 terms, but at least to get so a reader knows

14 where you are in space and time.

15 The whole issue of ventilation is

16 extremely important to dose. And extremely

17 important to effects. And particularly in

18 this dose chapter, the word exercise is used. 

19 But in most cases it doesn't have a modifier,

20 like moderate or very heavy.

21 And I'm thinking maybe even like a

22 little simple table. Like here's, you know,

Page 289

1 moderate exercise, this is this range of V dot

2 Es, and this corresponds to brisk walking,

3 whatever the case is.

4 And once you establish, here's the

5 definition of these terms, then you can keep

6 using words like moderate exercise or very

7 heavy, and not get bogged down in the details.

8 Let's see, I think that some of

9 the MOA is a real stretch. And I won't go

10 into detail, some of it's in my comments. 

11 Maybe it's that I'm less familiar with some of

12 the literature.

13 But the effects on testicular and

14 sperm function, it seemed to me that, boy,

15 you're pulling at teeth to try and get an MOA

16 for an effect that is kind of susceptible.

17 There's another -- Page 5-65

18 discusses attenuation of responses. And Fred

19 had kind of brought this up earlier. 

20 Attenuation needs to be defined. If you're

21 talking to like a policy maker, oh,

22 attenuation, oh, thank God, I don't need to
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1 worry about it now.

2 So there is an attenuation of

3 pulmonary function. And I think we all know

4 that there is not an attenuation of some of

5 the underlying inflammation and lung

6 remodeling that goes on.

7 And it could be that the

8 attenuation is actually the adverse effect, if

9 you will. Because if you're doing rapid

10 shallow breathing, it's going to keep a lot of

11 the ozone out of the deep part of the lung,

12 where some of those Type 1 cells are.

13 But once you no longer have that

14 rapid shallow breathing, once that attenuates,

15 then ozone just zips right on down. So all of

16 these are connected. And I think that notion

17 isn't brought out.

18 I guess the part that concerned me

19 most was on the issue of extrapolation. The

20 animal to human extrapolation, I think tone21 wise, in this chapter, and in the other

22 chapters is two-thirds empty. And in my

Page 291

1 opinion it's two-thirds full. Maybe the truth

2 is it's half and half. I don't know what the

3 truth really is. But all I know is this, that

4 the animal toxicology studies, they provide us

5 with what you say here, like biological

6 plausibility, things like that.

7 One thing that's not mentioned in

8 any of the chapters, the animal tox studies

9 provide us with a range of effects. If it

10 weren't for some of the animal studies, we

11 wouldn't know that Type 1 cells are going away

12 and being replaced by Type 2 cells that's

13 going to influence gas flow.

14 We wouldn't know what's really

15 happening in terms of pathology in the nasal

16 passages. Pathology in the respiratory

17 bronchials. We just wouldn't know.

18 And even in the text this stuff

19 is, you know, thrown out all lung remodeling. 

20 I did a search, and this maybe is also true of

21 Chapter 6. I did a search. I couldn't find

22 the word Type 1 cell, whether I caught it with

Page 292

1 a capital 1 or number 1.

2 I mean, so this detail, this

3 richness, what did the animals tell us? Mary

4 Amdur wrote a whole paper once, "What did the

5 Animals Tell Us?" And they tell us a lot.

6 So my preference for this whole

7 later section here, where it's homology and

8 sensitivity -- homology and sensitivity, what? 

9 That's boring. I mean, what this story is

10 about is animal to human extrapolation.

11 It has elements in there of

12 interspecies dosimetry, interspecies

13 sensitivity. And it has elements of

14 qualitative and quantitative.

15 And I would like to see a flat out

16 statement to say that there is, because of all

17 the similarities between animals and humans,

18 there's solid reason to believe that the

19 qualitative extrapolation will hold.

20 If you see the effect in several

21 animal species, it is likely that it could

22 occur in humans if exposure were sufficient. 

Page 293

1 Now the word "if" is the quantitative

2 extrapolation that we really aren't

3 sophisticated enough to understand yet.

4 But if you put this in a context,

5 it will set the stage for a more direct

6 utilization of the human studies, the animal

7 studies. And even in the summary, there's one

8 paragraph on extrapolation. I mean, it just -

9 - so that's the whole thing about

10 underestimation of the value of animal

11 studies.

12 DR. SAMET: Okay. Steve, I wonder

13 if you have any comments on the genetic bit

14 here.

15 DR. KLEEBERGER: Later.

16 DR. SAMET: Later? Okay, okay. 

17 And then, just to -- Jim.

18 DR. ULTMAN: I had one -- oh, I

19 still have my mic on. I have one follow up

20 comment after hearing Fred's comment. And

21 again, it goes back to this, what's causing

22 the effect of inhaled ozone, is it the ozone
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1 molecules themselves that are reacting with

2 tissue or the reaction products.

3 And I think that one possibility

4 that would strengthen this discussion would be

5 to have some information on the various

6 components of what determines this, and how

7 important those components might be, and what

8 the uncertainties are, et cetera.

9 I'll give -- there is at least

10 one, probably two models, of reaction

11 diffusion through the ELF layer. There's at

12 least the one classical one, but there's

13 probably one or two more in the literature.

14 And I'm not suggesting that you

15 put the model equations in and explain the

16 whole thing. But maybe a graphical approach

17 could be used. Because there are various

18 factors. Fred mentioned the thickness of the

19 mucus as one factor in these models, as it

20 would be in physical reality.

21 Another factor would be the

22 reaction rate constants of the molecules

Page 295

1 involved. And if you look at the literature,

2 there's a huge variation. And that's --

3 actually, you mentioned that in the chapter.

4 There's a huge variation in what

5 is known about these reaction rate constants. 

6 There's the concentration of the substrates. 

7 There's the secretion rate of some of the

8 substrates, like uric acid, from the tissue

9 space itself. So there are various factors.

10 So I think if you could somehow

11 enrich the chapter, maybe with a paragraph

12 somewhere which explains -- and maybe a graph,

13 which shows what these various factors are,

14 how they effect the -- whether ozone is

15 causing the damage, or whether it's some

16 product. And what the sensitivity to these

17 various things might be.

18 I think it's not the -- it depends

19 on how you allocate your time. But it's not

20 beyond the current state of the literature to

21 do this. I'm not asking you to do a complete

22 remodeling and re-analysis. But I think it's

Page 296

1 a possible thing. And that might also help to

2 prioritize which products or which species are

3 more important than others.

4 DR. SAMET: Let's see, Fred, yes.

5 DR. MILLER: Judy's comment about

6 exercising, that trigger, to me you could

7 actually use Table 6-25 of the EPA Exposure

8 Handbook, where different exercise levels are

9 described in terms of pushing a wheelbarrow,

10 or moderate exercise, and so on.

11 So that you could, in fact, have

12 something like that in there. And then when

13 you refer to moderate or heavy exercise, a

14 person would already automatically be

15 conditioned to what kind of things you're

16 talking about.

17 DR. SAMET: Okay. I can see now,

18 CASAC meeting participation would be like

19 zero. And then you would move up from there.

20 (Laughter.)

21 Yes. I actually have two general

22 comments. One, doesn't this chapter need a

Page 297

1 different title? And I don't know what it is. 

2 But you don't really describe what the chapter

3 is about right now. Because part of it is

4 about the terminance of response. So you need

5 a better title.

6 And then the only other general

7 comment. And I can't remember who made this

8 in their individual comments. But there's got

9 to be a lot of clean up in this document on

10 concentration exposure, dose. There's a lot

11 that's wrong. 

12 And if you work on that, this cost

13 integration, bottom of page, Chapter 6, 5,

14 there's an absolute misrepresentation of a

15 potential inhaled dose, or whatever you want

16 to call it, versus exposure.

17 In this chapter it says that

18 exercises increases exposure. Well, if

19 exposure is C x T, exercising does not

20 increase exposure.

21 So I really think you need to set

22 out some -- you know, there's standards for
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1 this. I mean, you don't have to invent it. 

2 And set up the terminology. And then just go

3 through and make sure it's been used

4 correctly.

5 And again, for example, in this, I

6 kept reading V sub E. Well, it's actually, I

7 think, when you mean ventilation, standard

8 terminology is V dot sub E, of course. Maybe

9 your problem is getting the dot over the V. 

10 And when you figure out how to do it, tell

11 Fred how to do it.

12 But then the nomenclature, it just

13 all needs to be cleaned up. And I really

14 actually recommend that you go through. And

15 I think one of our commenters, maybe it's

16 Fred, maybe it's Judy, somebody gave you some

17 guidance on this. And it just sort of grates

18 when you see these things. Let me ask if

19 there are other comments on this. Yes, Jack.

20 DR. HARKEMA: So I reviewed this

21 the previous time. And I did go through a

22 thorough reading this time and then knowing

Page 299

1 about the health effects.

2 Well, one thing that -- I'll put

3 my pathology hat on here -- it just does not

4 seem to me logical to present mode of action

5 before you have a discussion of health

6 effects. And I -- it was like you needed to

7 have a place to put mode of action so you

8 threw it in with dosimetry.

9 And it just -- I think that's kind

10 of the sum of the problem that we're having

11 here, is that you don't present the health

12 effects before concluding with the mode of

13 action. I would never write anything with a

14 mode of action without describing the health

15 effects.

16 DR. GRAHAM: Jon.

17 DR. BRAIN: It's really not the

18 full mode of action, isn't it? It's just the

19 initial biochemical reactions --

20 DR. GRAHAM: No, no.

21 DR. BRAIN: I mean, it doesn't go

22 through all the --

Page 300

1 DR. SAMET: No, it's a little more

2 in depth though --

3 DR. BRAIN: I mean, all the mode

4 of action can extend to how it effects

5 electrical stability to the heart and, you

6 know, airway muscle remodeling. I mean,

7 that's a big topic.

8 DR. SAMET: Judy.

9 DR. GRAHAM: Yes --

10 DR. BRAIN: I mean you sort of

11 take it up to a certain point.

12 DR. GRAHAM: Yes. I would have

13 said the same thing, but I ran out of paper

14 for my comments. Joking aside, I believe the

15 same thing. And I decided not to just

16 reiterate that.

17 In my opinion, the proper MOA

18 that's in this chapter is how the ozone gets

19 into through the tissue, where it may lead to

20 extra pulmonary effects, or set up

21 inflammatory changes right then and there.

22 And I think I made that comment

Page 301

1 before. And I think the decision was made to

2 keep the MOA here, with the explanation of,

3 well, you don't want to have the same thing

4 duplicated in the acute and the chronic

5 chapters.

6 And that's true. But a lot of the

7 MOA stuff, like for inflammation, is really

8 relevant to acute. So some of the MOA that's

9 here, it actually could be put in the acute or

10 the chronic chapter, along with the text.

11 Because when you actually get to

12 Chapter 6 and get to Chapter 7, there's an

13 attempt to repeat the MOA. There's some

14 cross-referencing, so I want to give credit to

15 that cross-referencing. But there still is,

16 there's a duplication that happens of

17 necessity, simply by virtue of the

18 organization.

19 DR. SAMET: Judy, would you

20 suggest -- I mean, a consideration would be to

21 have a separate chapter that pulls it out and

22 then can be referenced. I don't know. I
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1 suspect that there was some struggle about

2 what to do. And you ended up with one

3 solution to the problem. But would it be

4 better to have a separate chapter?

5 DR. GRAHAM: Well, I'd be happy to

6 leave that decision to EPA. I think that

7 there are three choices. One is the way you

8 have it now. The other is to have a separate

9 MOA chapter. It would look better. And the

10 other is to, you know, stop the MOA at the

11 molecular. And then when you go further, have

12 that further be part and parcel of the

13 discussion of the effect itself.

14 DR. SAMET: Fred.

15 DR. MILLER: Another solution,

16 Chapter 5 becomes 7, and 6 becomes 5, 7

17 becomes 6. And you discuss after the effects,

18 what's the likely dose and the mode of action.

19 So even Jack's concern would be

20 better if he was actually reading this from,

21 you know, Page 1 to, I don't know, 4000,

22 whatever it is. You know, you'd at least

Page 303

1 maybe find that a little more palatable.

2 DR. HARKEMA: Actually, I thought

3 that's a good suggestion, is change the order

4 of the chapters.

5 DR. GRAHAM: But you need dose. I

6 mean, I think that conceptual needs to be

7 exposure, dose, response. And so, you know,

8 the Chapter 5 still needs to be in between the

9 exposure and the effects.

10 DR. SAMET: You can see we're

11 giving a crisp solution here.

12 (Laughter.)

13 DR. SAMET: Yes. John, do you have

14 any comments on that?

15 DR. VANDENBERG: Yes, this

16 actually is exactly the kind of discussion

17 we've had. It's hard to figure out where it

18 is without getting into a lot of redundancy. 

19 We don't want to have a lot of redundancy.

20 So we put it together, and maybe

21 it's a bit of a force fit. So your comments

22 are, again, are noted. Perhaps it's the mode

Page 304

1 of action part, in particular, that might go

2 later to explain why you're seeing the

3 effects.

4 And that might be a natural split

5 there. Because I think our tendency has been

6 very much dose precedes effect, or response,

7 you know. And so maybe that's one of the ways

8 we could look at it.

9 DR. SAMET: But it seems to me

10 that if -- you know, just looking at it, if

11 you took it down to sort of this level of

12 tissue cellular dose, and you stop there, then

13 the modes of action are not divisible into

14 acute or chronic. I mean, inflammation being

15 a good example.

16 So that, you know, maybe, at least

17 in my mind, it would be preferable to have the

18 mode of action come before as sort of a

19 mechanistic set up for Chapters 6 and 7.

20 And then maybe you could cut back

21 some. But I, you know, there's multiple ways

22 to go. And I suspect we're not going to come

Page 305

1 up with strong preference around the table.

2 But if you stick with what it is,

3 I think this chapter does need to somehow be

4 brought together or better explained. And

5 maybe if you pulled out the mode of action

6 material and you have a shorter chapter. I

7 think then -- it's also the question of where

8 some of the stuff on genetics goes. And, you

9 know, we'll come back to that I guess when we

10 get to Chapter 8.

11 So maybe we could hold the

12 discussion until we move a little further

13 along in the document. It looks like there

14 might be some better ways to do it than what

15 you have.

16 DR. BRAIN: I would just point out

17 that in the Executive Summary, again, the

18 sections are human exposure, dosimetry and

19 modes of action. And then ozone health

20 effects. And for me, at least in the

21 Executive, it works. I mean, that seems to be

22 kind of a logical flow.
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1 DR. SAMET: Okay. So why don't we

2 leave this question and go to Michelle and the

3 team on Chapters 6 and 7. This shouldn't take

4 long.

5 DR. BELL: I'll just need two

6 seconds, all right. So first of all, when I

7 looked through the preliminary comments that

8 people submitted, I was very encouraged that

9 people are largely on the same page. So we

10 have a lot of consistency. And we'll see that

11 when other people respond, I hope.

12 A lot of my comments, that many

13 other people mentioned as well, correspond to

14 both Chapters 6 and 7. So I'll start with

15 those.

16 And the first is that I, and many

17 other people, found this version to be

18 substantially improved over the previous

19 version. Personally, I was extremely

20 impressed. Because we gave you a lot of work

21 to do. And it's very obvious that a lot of

22 work was done.

Page 307

1 Some of the things that are much,

2 much better are the organization. There's a

3 big expansion of these chapters. There's a

4 lot more clarification, more information on

5 the studies. I thought all of that worked

6 very, very well, especially for Chapter 6, but

7 both of the chapters.

8 One issue that got better, but is

9 still there, is this issue that relates to a

10 lot of the other chapters as well, of the kind

11 of the new studies versus the old studies.

12 And because it's obvious different

13 sections of this were written by different

14 people, how that's treated tends to be a

15 little different in different parts of the

16 ISA, which I'm sure we want to clean up.

17 But very often the words like new

18 and recent refer to things within the past few

19 years, I think. Or very often they refer to

20 studies that came out since the last ISA.

21 I think part of what happened here

22 is that there is an effort to keep this more

Page 308

1 brief and to not keep rehashing the old

2 documents.

3 And several times in these

4 chapters they refer back to previous ISAs, or

5 the previous criteria documents. I personally

6 did not think that worked. It's not going to

7 be a brief document.

8 I mean, it's already two phone

9 books. If it was three phone books it

10 wouldn't be that much more unmanageable than

11 it is now.

12 So I appreciate the effort to be

13 brief. But I think that this, you know,

14 what's useful for regulatory purposes are not,

15 what's new science? But, what's the state of

16 the scientific evidence?

17 And it's useful to talk about how

18 that's changed since the last time. But to me

19 in both these chapters it just seemed like a

20 very artificial division. So I think you have

21 two options.

22 One is to expand this even

Page 309

1 further. And this is my personal preference,

2 to expand this even further and actually pull

3 in more of the previous studies that are very,

4 very relevant.

5 I don't mean every single study

6 that ever existed. But, you know, those kind

7 of mammoth tables and things like that, that

8 we always talk about begin kind of unwieldy,

9 they're incredibly useful. They're not just

10 useful for this process.

11 This is a useful document of the

12 state of the science. So it's already not

13 brief. So my preference would be to just blow

14 it up and make it even bigger. Because it

15 would better state the science. That doesn't

16 work for me.

17 Your second choice is to just be

18 very systematic about it. Like if you're

19 going to define at the beginning, and perhaps

20 a few reminders throughout the document, the

21 word new means studies since this date. Or

22 something like that.
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1 You could do that, not go back and

2 forth between new and recent. But pick your

3 favorite. And you could define it that way. 

4 If you just really can't stand option one,

5 which would be a lot more work.

6 But I do think you want to do

7 something about this issue, because it's a

8 little bit confusing. A point that relates to

9 both these chapters, and several reviewers

10 commented on this, relates to other chapters

11 as well, is, you know, there's several new

12 studies to pull in.

13 I and many others are going to

14 give you some specific examples. But given

15 that there's been a lot I think it's worth

16 considering whether or not you actually want

17 to do a new literature review.

18 And part of your decision might be

19 whether or not we actually go to a third

20 round. And do a third round of, a third draft

21 of the ISA. Or whether or not we have Jon's

22 optimistic view point.

Page 311

1 But, you know, at some point you

2 have to cut it off. I mean, you can't just

3 keep going on and on and on forever. But

4 we've gone on for a while. And I feel like

5 it's something that should be considered.

6 So my recommendation is not to do

7 that, but to consider that in light of

8 whatever time line develops. And EPA can make

9 a decision.

10 There were a few parts for the

11 human clinical studies where I think some more

12 information could be used. And Judy might

13 want to talk about this more, because her

14 comments talked about this a bit.

15 What are kind of the real world

16 implications of some of the settings of the

17 human clinical studies? And what are the true

18 effects at kind of the lowest exposure levels

19 used in the human clinical studies? So that

20 could use some more expansion out.

21 With Chapter 7 in particular, one

22 issue, well everything else I'm going to

Page 312

1 mention for Chapter 7 is stuff that has been

2 improved a lot. So I want to give UPA a lot

3 of credit for that. But I think we still have

4 a little ways to go.

5 And one is this issue of what does

6 it mean for long term exposure? I really

7 harped on this last time. And it's gotten a

8 lot better.

9 There's definitions at the very

10 start of the chapter. This is what we mean by

11 long term exposure. And so that works much,

12 much better, until you get to tables and

13 discussion of exposures of a single day.

14 I still don't understand why

15 they're in there. And it happened a lot. 

16 It's not like one or two things that slipped

17 in. It's clearly a conscious decision on the

18 author's part to include these short term

19 exposures in the long term chapter.

20 What I think is happening, and I'm

21 interested to hear from UPA what it happening. 

22 What I think is happening is that they're

Page 313

1 trying to group all the birth outcome studies

2 together. Because that's where it tends to

3 show up.

4 So again, I think you have a

5 couple of options. One is to start off at

6 that chapter and somewhere explain, like

7 explicitly tell the reader, we're going to

8 have some short term studies in here. Because

9 we really want to group birth outcomes.

10 This is not my first choice. I

11 think you're going to have to provide a

12 rationale for that. I mean, the whole

13 division between Chapter 6 and 7 is that we're

14 splitting exposures for things like

15 respiratory mortality. We split them.

16 So why you don't want to do it for

17 birth outcomes, but we do it for everything

18 else is confusing. I mean, this is a very

19 fixable thing.

20 So my preference would be to move

21 the short term exposures to the short term

22 exposure section. So this is stuff in Chapter
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1 7 that deals with a few days. There's tons in

2 here that's like a single day exposure. Or,

3 if you can provide a really good rationale,

4 move it.

5 So I'm interested in other

6 people's thoughts. But personally it makes a

7 lot of sense to me that, you know, it could be

8 a different biological mechanism happening

9 when you have a one day exposure for infant

10 mortality versus the gestation long exposure

11 for low birth weight. I have no problem

12 splitting those up myself.

13 And my final comment, which

14 relates to Chapter 7. One thing that I asked

15 for last time, and I think other people asked

16 for as well, is to change the standardization

17 of units, so that you don't have one study

18 giving a risk estimate for 5 ppb and another

19 study giving a risk estimate for 15 ppb, and

20 you're looking at those numbers together.

21 So that has largely been addressed

22 where you have this kind of standardized unit. 

Page 315

1 They've converted on the different metrics. 

2 So you have an increment for the 24 hour

3 that's kind of comparable to an increment for

4 the one hour max, and so on.

5 There's just two issues with that

6 that still need to be fixed. And again, these

7 are fixable things. One is, the description

8 of that is sometimes buried in footnotes. I

9 would pull it out.

10 I don't think this is just an

11 editorial issue. I think that this is going

12 to be confusing for people if we don't. So I

13 would suggest pulling that out.

14 There's several places where it's

15 very nice. In the tables it will say, you

16 know, standardized unit, or something like

17 that. And I think that that language, using

18 standardized unit, is really nice.

19 That was not my suggestion. I

20 don't know who came up with it. But I thought

21 that worked very well. But here's something

22 that does not work at all.

Page 316

1 A standard increment of ozone

2 increases respiratory mortality by five

3 percent. There's no such thing as a

4 standardized increment of ozone. I really

5 don't think we want to define it as 10 ppb,

6 and then use that throughout the document.

7 So although I think it was an

8 absolutely necessary improvement to move

9 towards comparable units, I don't like to see

10 the numerical values replaced with the word

11 standardized.

12 So instead just say 10 ppb. I

13 think that's going to be very confusing to

14 people. So that's something just where you

15 have the word standardized increment,

16 replacing a number in a sentence, you can just

17 flip it back to the number.

18 And the ratio that's used to

19 convert between the different temporal

20 metrics, the 24 hour, the daily eight hour

21 max, and the one hour max, are not the same

22 throughout Chapter 7.

Page 317

1 I don't know if this is because

2 it's different authors. But you can't use

3 different ratios to convert those in the whole

4 ISA. And you really don't want to do it in

5 the same chapter.

6 So in my written comments I'll

7 give more details about some places where I

8 caught this. But you also just want to go

9 through and make sure you have the same

10 conversion amongst temporal metrics throughout

11 the whole document. And that's all of my

12 major points.

13 DR. SAMET: Okay. Thanks

14 Michelle. Mike.

15 DR. FOSTER: So I really echo

16 everything Michelle said. And she's right. 

17 When we looked at each others comments, I

18 think Jack has a much greater laundry list,

19 and I don't want to take up too much of his

20 time.

21 But I felt that overall I focused

22 on the requests that were made. I did review
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1 Chapter 6 in the initial version. And I was

2 in charge of sending through to the group and

3 editing out and sending the questions on to

4 John's group.

5 And I thought they were answered

6 quite well. I think you addressed this, at

7 least in Chapter 6, I think you addressed

8 quite well the question over adaptation and

9 attenuation, those kind of issues.

10 You didn't confuse the

11 terminology, I didn't believe. I think you

12 dropped out some of the information. The

13 things that we did ask you to do increased the

14 volume of the text.

15 It went up by my calculation about

16 30 percent if you just looked at increased

17 figures and page numbers of the text, and 31

18 pages of references.

19 So I think the rest of this panel

20 got off easy by not having to review this

21 chapter. I mean it was, it was a good eight

22 hour flight to Europe and coming back that I

Page 319

1 got through it. So I mean, it was a lot of

2 work.

3 But I think one of the things I

4 just noticed, because it's kind of something

5 that I kind of think about more to my own

6 research, was the fact that there was the

7 ability to draw in, say a respiratory effect

8 in a susceptible population, with a mortality

9 effect in that same ethnic population.

10 And I noticed that they were

11 disparate. They were in the beginning of the

12 chapter and at the end of the chapter. And I

13 made comment in my comments about that. 

14 Something's jumping out at you like that,

15 there might be something more to it than just

16 a random thing. That there's parallel effects

17 in this ethnic population.

18 But I thought overall, once again,

19 I reiterate everything that Michelle said. I

20 thought, I did have trouble with, I didn't put

21 it in my comments. But when I read her

22 comments about distinguishing short and long

Page 320

1 term, I guess we need some definition of what

2 is meant by that.

3 I did add in some new references

4 that I thought might be helpful. You don't

5 necessarily have to use those. They are, with

6 some bias, pretty much related to my own

7 laboratory or people that I collaborate with. 

8 But I think they're appropriate. And so I've

9 indicated those. And outside of that, that's

10 about it, Jon. Thank you.

11 DR. SAMET: Okay. Sverre.

12 DR. VEDAL: Yes. While I'm

13 thinking about it I'll just react to the issue

14 about new information versus old information. 

15 I fully agree with the issue of having that

16 standardized. I think that's helpful.

17 But I do find it useful to

18 distinguish the two, just to focus my own

19 thinking about where the field has gone since

20 the last review, rather than putting the

21 entire world of research together here in this

22 one document.

Page 321

1 And I think that the way that this

2 has been moving is to have a more concise

3 document as time goes on. And I think it

4 works in that way. But again, I think the

5 point about standardizing, you know, what is

6 new and what is old is important.

7 Take a little bit of a different

8 tack too with my responses. I'm going to

9 touch a little first on sort of the lung

10 function stuff.

11 I'll try to be brief about that. 

12 I know there's been some de-emphasis on this,

13 even though it still plays a very central role

14 when we think about concentrations and levels

15 for the standard.

16 But just a few quick points. This

17 issue of the acute lung function response in

18 some sense has been a very difficult pill for

19 many people to swallow.

20 That it's just, you know, this

21 neural mechanism that's going on. And in your

22 description of this effect you always bring in
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1 this broncho constrictive effect.

2 And a lot of people, you know,

3 there's evidence for it there. But, you know,

4 it's really not playing a big part, if any

5 part, in this acute response.

6 And, you know, you can't do

7 anything about it with inhale bronchodilators. 

8 You can't do anything about it with

9 corticosteroid administration. Maybe there's

10 something going on suddenly in the small

11 airways. But really who cares?

12 In this setting, it's this acute

13 little neural reaction that's going on. And

14 to try to embellish it and make it into

15 something more than that, I think is just a

16 misread of the, you know, of the data.

17 It's not inappropriate to talk

18 about those other things in other settings. 

19 But in terms of this acute response, I think

20 it's just misleading.

21 Milan Hazucha brought up this

22 issue of the filtered air with exercise

Page 323

1 versus, you know, how you characterize the

2 response.

3 And, you know, the one weird thing

4 about looking at comparing to sort of post

5 exercise responses is that, basically you end

6 up saying, well the effect of ozone is not to,

7 is to lessen the improvement that we have with

8 exercise, which introduces this notion of,

9 well how adverse is that really?

10 So it's, I don't know the answer

11 to it. I think maybe both things sort of need

12 to be presented in some way to sort of give it

13 the complete picture.

14 This issue of concentration time

15 and mini ventilation, you know, has been sort

16 of a standard thing with ozone in particular. 

17 It's kind of a poster child for that notion.

18 And it's presented here as well. 

19 But it's followed right away by this

20 discussion of square wave versus triangular

21 wave exposure, which in some sense undermines,

22 to my mind, undermines that initial concept to

Page 324

1 some extent.

2 And it's a little bit confusing, I

3 think, when they're presented in that way. 

4 Because they both can't be completely true,

5 right.

6 And then finally, you know, I

7 think there's been some discussion today about

8 this, is that I think there still is something

9 missing about trying to interpret this acute

10 lung function response in the entire spectrum

11 of, what does it all mean?

12 You know, there's something there

13 trying to bring in the panel study results and

14 such. But, you know, we have a situation here

15 where, as has been pointed out today, you have

16 exercise for six, well intermittent exercise

17 at a fairly, you know, moderate, brisk pace

18 for six some hours.

19 And then we're trying to say

20 something about, you know, effects of this

21 response on people where it really matters,

22 like severe asthmatics, or people with COPD,

Page 325

1 who probably aren't going to be doing this

2 kind of stuff anyway.

3 So something about trying to put

4 it together where it really does what, you

5 know, what the significance of this thing,

6 what you think the significance of this thing

7 is.

8 And, you know, you can try to do

9 that with bringing in some of the clinical,

10 not the experimental studies, but the panel

11 studies and such. And there's some allusion

12 to that I think.

13 The sensitive sub-population

14 issue, I'll just make a small point here. To

15 me it's kind of a little bit all over the map. 

16 And we'll be discussing some of it in the

17 Chapter 8 issue.

18 But I think whenever this is

19 described, I think you should never, never say

20 that sensitive sub-populations are blah, blah,

21 blah. The evidence doesn't support that. I

22 think it has to be characterized as
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1 potentially sensitive sub-populations at this

2 point.

3 I don't think I can point to

4 anything that would make me confident in the

5 statement that's saying this, as I said. 

6 Including young children, including the

7 elderly, our favorite sensitive sub-groups.

8 There's, in this, well most of

9 Chapter 6 and 7, I think one of my hobby

10 horses is selective. You know, selection

11 finding, selection of parts of studies that

12 tend to support a point.

13 I think there's much, much less of

14 that in this version of the ISA. And I really

15 like that. I think it's quite even handed as

16 a rule. And I found that refreshing.

17 With respect to sort of newer

18 findings again. The one thing where somewhat

19 surprisingly, I think newer data has in some

20 sense weakened the case rather than

21 strengthened the case, has been the issue of

22 respiratory symptoms and medication use in

Page 327

1 asthmatics.

2 And I'm particularly referring to

3 the multi-city studies that have looked at

4 those endpoints. And here we have an issue

5 where we've now got multi-city studies, which,

6 you know, there's a precedence for putting

7 more weight on multi-city studies. And

8 there's a reason for that.

9 And here we have multi-city

10 studies on those endpoints. And yet the

11 results are contradictory, and sometimes flat

12 out negative.

13 And the conclusions, with respect

14 to those endpoints are, everything's hunky15 dory. Things haven't changed. But I think

16 they actually have changed.

17 I'm not going to, with respect to

18 non-respiratory endpoints, and I'll try to be

19 very brief. And I think it's important, and

20 you've done this before in bringing up the

21 classic Henry Gong study from the late '90s

22 about talking about sort of effects on

Page 328

1 saturation and such.

2 Well they also demonstrated an

3 increased heart rate in that study, right. 

4 And it's like the first one was a human

5 clinical study where there's a cardiovascular

6 endpoint.

7 So it's important to not just, I

8 don't know why it's not there. But it does

9 actually help to sort of shore up experimental

10 evidence in that end point.

11 There's a statement that with

12 respect to cardiovascular effects, there's no

13 apparent biological mechanism to explain short

14 term ozone effects on cardiovascular

15 mortality.

16 Really? Because, you know, you

17 can by analogy use some of the same mechanisms

18 that are used for explaining the PM effect. 

19 And I think of two of them in particular.

20 Pulmonary inflammation. Okay, you

21 can make this case about spill over and

22 pulmonary inflammation, even thought the

Page 329

1 pulmonary inflammation is arguably

2 qualitatively different than that that occurs

3 with PM.

4 And then there's the neural

5 mechanism, which is front and center here with

6 ozone, about affecting airways, receptors,

7 autonomic modulation.

8 And once you have that, systemic

9 inflammation, oxidated stress, you're off and

10 running. So, you know, I think you can make

11 some fairly reasonable arguments about

12 plausible mechanisms.

13 Long term exposure effect. Try to

14 be very brief. There are basically two very

15 important new studies in the area of long term

16 effects.

17 One is the Children's Health Study

18 findings on new onset asthma. And the second

19 one is the American Cancer Society study on

20 respiratory mortality.

21 The new onset asthma, I've never

22 been a fan of the findings, the early findings
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1 on new onset asthma, where they show that

2 children who had like two or three more

3 activities outside had more risk of new onset

4 asthma.

5 There was a very small study. Now

6 the tack that these investigators have taken

7 is a gene environment interaction tack. What

8 I'm looking for is the main effect of ozone

9 exposure on this endpoint.

10 And to me the, and it's not their

11 fault. Their interest is in genes primarily. 

12 They've taken primarily a gene main effect

13 approach. And then sort of looked to see

14 whether ozone modified that.

15 And, you know, the bottom line was

16 that the effect was in low ozone communities,

17 where you had this differential between the

18 two effects of the polymorphism.

19 I still am not, I think at the end

20 of the day you kind of need to look at that

21 study again and just see whether it, you know,

22 it's within a central role. And I agree it

Page 331

1 should be. Children's Health study is a very

2 important study.

3 But in terms of the actual main

4 effect question, does ozone cause new onset

5 asthma? I think perhaps you should reevaluate

6 that.

7 The American Cancer Society study,

8 you know, is a very important study. And I

9 think what you did with interpretation of that

10 is good.

11 Final point, and it relates to the

12 issue of long term/short term exposure. And

13 I fully agree with the things that Michelle

14 said about that earlier.

15 There are some endpoints that

16 could be, including, you know, birth outcomes. 

17 But there are some other end points. ED

18 visits, hospitalizations that are, that can

19 and have been analyzed both in the long term

20 and the short term perspective.

21 Here it is in the long term

22 exposure chapter. But essentially here it's

Page 332

1 someone decides to define exposure based on a

2 long term averaging metric. And then make

3 some conclusions about these very, essentially

4 short term endpoints.

5 And it's basically determined,

6 pre-determined by how you define exposure. If

7 you're going to do that, you either have to

8 try to control for short term exposure

9 effects, so that you can try to tease out what

10 is, in fact, a long term exposure effect. Or

11 something else that allows you to sort of

12 distinguish those time scales.

13 Otherwise it's, you know, you're

14 basically following the path of where the

15 investigator wants to lead you about the

16 importance of long term exposure. And it may

17 have nothing to do with long term exposure. 

18 Yes, that's it.

19 DR. SAMET: Okay. Jack.

20 DR. HARKEMA: So I had, this is

21 kind of the first time I reviewed this

22 chapter. So I don't, wasn't familiar with all

Page 333

1 the suggestions from the first time.

2 But in general I thought it was

3 very well written. And I agree with

4 everything that has been said, especially with

5 -- And Michelle was talking about putting it

6 in the context of previous studies and newer

7 studies.

8 I still would like to see that. 

9 And I think the epidemiology sections did that

10 fairly well. I think the toxicology sections

11 were a lot of detail on previous things that

12 were in the earlier documents. And I would

13 cut that back. I would rather have it focus

14 more. I wouldn't go to three volumes. I

15 would --

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

17 to three volumes.

18 DR. HARKEMA: But anyway, I think

19 it would flow a lot better there. And a lot

20 of things have already been said. There are,

21 I don't know I found three or four in there,

22 in press type of things.
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1 You don't want, maybe that was

2 just for you to clean up when you're doing

3 this again. But there's two or three

4 references that are in press. And that should

5 be corrected.

6 I thought there was a lot under

7 the controlled human exposures. There was

8 quite a bit of emphasis on why you're doing,

9 having an air control. And I think that's

10 good.

11 But then I think because of what

12 we heard this morning, and I put in there. I

13 think it would be wise to talk a little bit

14 about those studies.

15 Or if they hadn't done it, looked

16 at, you know, the exposure history before the

17 subjects come in, and that type of thing, just

18 in terms of background.

19 I especially liked the newer data

20 that came out of the cardiovascular. Because,

21 again that was the newer stuff coming in here. 

22 But I was a little troubled at the end, and

Page 335

1 this goes to sort of a general comment about

2 causality in these different hierarchies here.

3 I can't figure out how you can get

4 cardiovascular effects being a suggestive or

5 a causal relationship. And mortality, where

6 you emphasize in the short term, we're not

7 talking about long term, but the short term,

8 cardiopulmonary related mortality. And that

9 is a likely to be causal relationship.

10 And so I think there needs to be

11 some more in-depth rationale of why you're not

12 giving likely to be cause relationship for

13 the cardiovascular if you're going to stick

14 with the mortality. Or talk about the

15 mortality being more respiratory or something.

16 But there was a disconnect there

17 for me. In fact, I'm worried about in the

18 Executive Summary, or the Chapter 1 now, the

19 preamble in Chapter 2, that those

20 cardiovascular things are going to be lost.

21 And I know you only have a figure

22 there now, a triangular, a pyramid for the

Page 336

1 respiratory effects. And there's nothing

2 there for cardiovascular, which predominantly

3 was the newer stuff that is coming out. 

4 That's not emphasized.

5 Now maybe that's the conclusions

6 that you were trying to make here. But I

7 still think there's a lot of this

8 cardiovascular that we don't want to, you

9 know, forget about not emphasizing in the up10 front.

11 The other thing is about exposure

12 again. And reading through the exposure like

13 Sverre was talking about the square wave or

14 the triangular exposure. There was a lot of

15 discussion about exposure.

16 And then you came to the next

17 section. And the next section, I forgot

18 exactly what it was. But there was really no

19 mention of what type of exposure it was that

20 the animals were, or the humans were getting.

21 And this whole discussion about,

22 you know, the importance of square wave, or

Page 337

1 triangular, that emphasis. And then all of a

2 sudden it was just a regular old exposure.

3 So if, you know, then you kind of

4 lost well, what's the importance of square

5 wave or triangular. And there is overall I

6 think it captured almost everything that I

7 would like to have in those sections.

8 But there was no, you know, the

9 importance of it, you know. So what is a

10 square, why is it important to have square

11 wave or a triangular wave? And that can be

12 simply, you know, very simply addressed there.

13 There are some sections, I think

14 the section on pre-existing diseases, that

15 there was sort of a lack of explanation of

16 what type of exposures were actually

17 conducted. So that needs to be looked at as

18 well.

19 I think I want to also mention

20 that not only are there some references where

21 you had one day exposures, or something like

22 that in the long term. But you also had some
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1 areas, and I'm not going to go through that,

2 where there were some longer exposures that

3 were captured in the acute short term

4 exposures as well.

5 I would like to see a little bit

6 of more integration between the epidemiology

7 and the toxicology. I don't know if that's

8 possible. But you can -- I think that would

9 be a good thing to do.

10 And I would like to see more of

11 each topic having a summary, and not just

12 listing of studies and then going on to the

13 next one. And you kind of fall into that

14 patterns sometimes. The overall summaries I

15 thought were very good and nicely written.

16 And then finally, I just bring up

17 one study in the cardiovascular that I think

18 should be included here. Because it has

19 reference to one of the toxicology studies.

20 There was a study out of Emory

21 where they looked at infants that were on

22 monitors. And they demonstrated that exposure

Page 339

1 they could have, there was a correlation

2 between ozone concentrations and bradycardia.

3 And that goes a lot with

4 cardiovascular science that Penn Watkinson

5 showed several years ago. And I thought that

6 would be a really nice, you know, correlation

7 and that, as a recent study.

8 So I wouldn't minimize. There was

9 kind of a minimization of that effect of this

10 decrease in heart rate in the animal studies. 

11 Well these are rats, and so on.

12 But it's probably most likely

13 that's due to a trigeminal cardiac reflex. 

14 And that's the most powerful autonomic reflex

15 that we know of in mammals.

16 And so that study, along with that

17 recent study out of Emory is a nice example to

18 put in. Other than that, I don't think I have

19 to go on with others.

20 DR. SAMET: Okay, good. Thank you

21 for advocating for the rats. Let's see. 

22 Okay, John Bailar can't be with us, but I just

Page 340

1 wanted to -- He had sent an email earlier,

2 raising one point.

3 And I think I want to sort of go

4 back and refocus you a little bit on some of

5 the bottom-line conclusions as well. And

6 whether you are in agreement, more or less,

7 with the level of strength of evidence that

8 the chapter reaches around that calls some

9 conclusions.

10 John's brought up a point. And

11 I'll just read a little bit. Finding that the

12 strength of evidence for an effect on a broad

13 category of outcomes is lower than the

14 strength of evidence for some components.

15 So one example, let's see. One

16 cannot have, for example, an increase of

17 cancer of the lung without an increase in

18 total cancer, whether it's direct evidence of

19 that or not, except in the unlikely event that

20 there are compensating decreases elsewhere.

21 And I think as we go back and look

22 at the conclusions we should look at some of

Page 341

1 the endpoints used. I think sometimes this is

2 not really, the way things are grouped is not

3 necessarily coming from agency decisions, but

4 the way epidemiologists have grouped.

5 And very often I think we use

6 these rather non specific, it's not a

7 confession, groupings. Because numbers are

8 increased and you end up with something like

9 total cancer, which doesn't really have

10 specificity when you get to something like

11 ozone, unless there's some broad overarching

12 mechanism that one would think about.

13 So we should just, I think, look

14 at John's comments. But I do want to go back

15 through the group. And you've talked a lot

16 about the methods and the presentation. But

17 what about the bottom lines here?

18 And then I have one other comment

19 I'll make after that. I just want to make

20 about this new/old/recent bit. So Michelle,

21 Sverre, anybody?

22 DR. VEDAL: Well I think the one
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1 that we should address is the one Jack brought

2 up, which is this apparent inconsistency where

3 in the short term there's a suggestion on

4 effect for, I guess, cardiovascular disease. 

5 And then a likely effect for total mortality.

6 Now, so I mean, in some sense

7 those are logically inconsistent. And, you

8 know, what the options are to maybe downgrade

9 one, or upgrade the other.

10 And, you know, I think I'm on the

11 same page as Jack in this. And it would be to

12 upgrade the cardiovascular evidence, or the

13 classification.

14 DR. SAMET: Because you view the

15 evidence as sufficiently strong?

16 DR. VEDAL: Yes. Yes, as a whole. 

17 I wouldn't do it based on just the epi. But

18 I think given the new tox data, I would, yes.

19 DR. SAMET: Okay. Michelle, do

20 you have any comments?

21 DR. BELL: Yes. I think I agree. 

22 I would probably upgrade it as well. I mean,

Page 343

1 it's difficult, you know, if you have

2 something like likely causal. And I might

3 call it like, highly likely. But we don't

4 have that. And we shouldn't. But I would not

5 be opposed to upgrading it.

6 DR. SAMET: Anyone else? Mike, do

7 you have any comments on the overall, the

8 causal classifications designations? Are you

9 comfortable with what they are now?

10 DR. FOSTER: Jon, you know, for

11 the respiratory mortality it was likely. And

12 it wasn't nearly as strong as we've given for

13 the respiratory effects.

14 And Michelle and I both found some

15 disagreement. And we thought that the

16 evidence for mortality and respiratory

17 mortality to be very, very strong, with all

18 the recent data that John's group had added.

19 So it seems to me that when

20 comments are developed, that this is something

21 that at least if the panel feels that there

22 should be a change in the classification of

Page 344

1 any of these, whether up or down, that there

2 be a clear comment and expectation.

3 Probably for the point of view of

4 peer review there ought to be, yes we agree

5 with what is there or not there. Or at least,

6 it's not that we agree with what is there or

7 not there, but the agency has made the case

8 for what they have determined. I think that's

9 really the critical.

10 DR. BELL: Jon, can I ask, since

11 I'm going to be the one writing up our

12 section. Is it our role to advise EPA to

13 reconsider their classification? Or is it our

14 role to tell them what we think it should be?

15 DR. SAMET: I would suggest it's

16 our role to advise them. We are back to the

17 Clean Air Scientific Advisory Committee, to

18 advise them. And say, here's why you might

19 consider doing this.

20 DR. BELL: Right. But not to

21 advise them what it should be? Just advise

22 them to reconsider?

Page 345

1 DR. SAMET: Well, I think --

2 DR. BELL: Or can we advise them -

3 -

4 DR. SAMET: No, I --

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

6 -

7 DR. SAMET: I don't think --

8 DR. BELL: Are we going to suggest

9 a specific classification?

10 DR. SAMET: I think you might

11 suggest on the strength --

12 DR. BELL: Okay.

13 DR. SAMET: -- of evidence, where

14 it's an upgrading or a downgrading, one way or

15 the other. Yes, Judy.

16 DR. GRAHAM: Yes, a couple. 

17 There's one area here where, you know, we

18 can't reach a consensus. One area that also

19 impacts the summary. And that is lung

20 inflammation is mentioned. Increased pmms are

21 mentioned.

22 But it's given short shrift. So
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1 example, I can go here in the text and find

2 out what the percent change in FEV1s was. I

3 cannot find what the percent change in pmms

4 was in the same exact study.

5 And in my view at least, I'm more

6 worried about lung inflammation than I am

7 about a fleeting change in pulmonary function. 

8 So I think that whole issue needs to be beefed

9 up, and more attention given to the severity

10 of some of these endpoints. So it's more

11 possible for policymakers to say this is

12 adverse, this is not adverse.

13 I guess one of my concerns is, we

14 obviously don't have consensus on two issues. 

15 And that is the old versus the new in the

16 tables.

17 I'd like to be a proponent to

18 eliminating the distinction between the old

19 and the new. The reason I say that is, this

20 is not just any document. This is the

21 foundation of the NAAQS.

22 The NAAQS is to protect people

Page 347

1 against adverse effects, not just effects that

2 were discovered in the last five years, but

3 effects.

4 And even if you take, like take

5 the richness of human clinical. If I went

6 through and erased all the old stuff, we would

7 have some excellent new studies. But we

8 wouldn't have the weight of evidence.

9 If I took away all the old animal

10 tox we wouldn't have the weight of the

11 evidence. We wouldn't even really understand

12 some of the old effects.

13 So I don't see that there's any

14 distinction, there should be any distinction

15 between them. I think the fact that there is

16 a distinction as to impacts.

17 One is that it's an excess

18 duplication. Because some of them you say

19 here's the old, here's the new. And then here

20 comes some more old to buttress what I just

21 said.

22 In some cases it's actually

Page 348

1 misleading to talk about the new if it's not

2 in contrast with the old. So it gets very

3 confounded.

4 If it were just the story of

5 here's what ozone does, and not having all the

6 old information equally presented is not so

7 bad.

8 It would include extending the

9 tables. But the text doesn't need to be

10 extended in a corresponding way. In fact, the

11 text would decrease by removing some of the

12 duplication.

13 So if you see, you know, here's a

14 whole class of the facts. Have a paragraph

15 describing the class of the facts. Right now

16 the text is buried. Well parentheses, how

17 many hours of the day was the exposure?

18 All the details are buried in the

19 text. If they were in tables some key studies

20 could be selected. In some cases the key

21 studies would be the old ones.

22 In some cases an old study of .12

Page 349

1 ppm in an animal, which is given short shrift. 

2 And there was a whole paragraph devoted to a

3 1 ppm study. So I think that we need to keep

4 our eye on the science, and not our eye on the

5 date.

6 The allusion I offered in my

7 comments was, I'll use the word silly to make

8 the point. In three cycles from now, do we

9 want to just have an ISA of one page saying

10 nothing's new because there is no new money in

11 research? Go read five old documents.

12 In some cases the reference, it

13 says, go read the 1986 tables, for God sakes. 

14 So, I mean, I think that we are worshiping a

15 false God of page length. We need to worship

16 at relevance.

17 So that's my argument for that. 

18 And as a fine point, these are questions for

19 Jon. It bothers me about the Adams 1998 data

20 being unpublished and not being in the

21 document, given that EPA has no access to it.

22 I think that some of the data he
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1 published openly. But it's still, unpublished

2 data is kind of nails on the blackboard. And

3 the other question I have, this is one of the

4 public commenters mentioned about all of the

5 Kim data.

6 I presume that you guys are really

7 trying to get all of that data out into

8 publication so the next revision can have the

9 other subjects, the other exposures, the other

10 findings.

11 DR. SAMET: So just, one moment. 

12 Just to elaborate on what Judy said. It seems

13 to me that there's again, coming out of these

14 chapters for each of the health outcomes

15 there's two bottom lines.

16 One is the strength of evidence

17 and what do we know about the concentration

18 response relationship? And those are what

19 really is critical for moving forward into the

20 REA.

21 If a causal determination has been

22 previously made, there's probably not too much

Page 351

1 need to say what is the new pile of evidence?

2 If I'm buying the Surgeon

3 General's report on smoking and lung cancer,

4 I actually probably would not review the 100

5 new studies on smoking and lung cancer, since

6 the last, say, Surgeon General's report.

7 But I might be very interested in

8 say cigarette type or something like that, and

9 risk. It seems to me that what you get out of

10 the new information for those outcomes for

11 which there's already a causal determination

12 is new information on concentration response.

13 Perhaps an extension of the range. 

14 Perhaps some new information about what

15 modifies the concentration response

16 relationship. And that's where emphasis

17 should be given.

18 If you are judging the strength of

19 evidence then, as Judy points out, and others

20 have pointed out, drawing a line on the date

21 you happen to convene the first group of

22 writers, or whatever it is, is arbitrary. And

Page 352

1 it is the full strength of evidence that needs

2 to be done.

3 And it's not that evidence that

4 has come in the later cycle is better

5 necessarily than old evidence. Perhaps it is,

6 perhaps it isn't. But it's an increment to

7 what we know. And it's accumulative. That's

8 important.

9 So it seems to me you could make

10 those, that distinction. And not get caught

11 up in the old/new/recent, whatever's there in

12 the --

13 DR. VEDAL: Yes. But I think

14 that's what's done, in their defense. I mean,

15 in every single instance. It's not as if

16 we're saying, okay, you know, we're operating

17 as if there's no previous data.

18 And what's done, there's a summary

19 of what we know, and then what's happened

20 since. I think that works perfectly logically

21 and is actually very useful.

22 DR. SAMET: Yes, but it's a little

Page 353

1 --

2 DR. VEDAL: I think that --

3 DR. SAMET: -- more of a nuance in

4 the wording, Sverre. I don't --

5 DR. VEDAL: I think in the

6 integrated summary, you know, that sort of

7 discussion is where this big picture comes in. 

8 And it certainly shouldn't be ignored in terms

9 of causal classification. But in terms of

10 presenting, you know, new information, I think

11 it works perfectly well.

12 DR. SAMET: Fred.

13 DR. MILLER: I want to address one

14 of the points Mary brought up about square

15 wave versus triangle. In the '70s I published

16 about pulmonary function being dose rate

17 driven. And structural, morphological changes

18 being cumulative dose.

19 A Type 1 cell can only expand by

20 30 percent and then it dies. The neurological

21 aspects of the pulmonary function control in

22 that are the bombardment of the pressure
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1 receptors.

2 And what this gives credence to is

3 why Bill McDonnell's recent model, allowing

4 the exposure pattern, the profile, while he's

5 able to model both the square wave and the

6 triangle studies.

7 So, you know, the fact that these

8 are dropped here instead of 12, 15 percent for

9 the square wave versus the triangle on Page 6-

10 7 to about six or seven percent, is a function

11 of the dose rate, okay.

12 And so to me this is another

13 example of where this aspect of dose isn't

14 being factored into these discussions. And

15 this was explainable 30 some years ago.

16 DR. SAMET: Helen.

17 DR. SUH: Well, I guess actually I

18 thought, Jon, when you were talking about it

19 you were going to go one step further, which

20 is I think why the distinction between recent

21 and old is in the document.

22 It's really to show people why if

Page 355

1 there is a change or not a change in the

2 standard, why that is. Like, what is that new

3 information that makes you want to change or

4 stay with what the current course?

5 And I think that that's really

6 important. I think that's really important to

7 the public. I think it's really important to

8 other people to understand why was there a

9 change made.

10 So I think that no matter what you

11 have to have some distinction about how much

12 new is there so that you can know whether you

13 -- Because for example, something's causal,

14 you might want to say, well maybe it slipped. 

15 Maybe there was some important piece of

16 evidence that might make you slip.

17 But you want to have that

18 documentation about what is new and why that

19 makes you want to change or not change. So I

20 agree with you.

21 In terms of causality it doesn't

22 matter. And in terms of explaining things

Page 356

1 like modes of action or dosimetry, you've

2 really, it is the whole body.

3 But I think you can draw on the

4 whole body of evidence without having to

5 discuss each study individually. But I do

6 think you have to have in the document what is

7 new since last time. I think that's like a,

8 to me it's a given.

9 DR. BELL: I don't think anyone's,

10 I certainly was not suggesting that they

11 discuss every single study. And I was being

12 facetious when I said, you know, it could be

13 50 percent longer and still not be brief.

14 But I think where I'm coming from,

15 and where I think Judy's coming from, are

16 that, you know, just because you have new

17 studies doesn't mean you want to omit key

18 studies that you're using for the scientific

19 evidence.

20 You can imagine a situation where

21 there's almost no new studies, but you think

22 it's extremely causal. And so I think that a

Page 357

1 feasible way to move forward is not to

2 describe every study, but to include those key

3 studies that were prior to this review.

4 And to have, I guess this is one

5 point where I disagree with Sverre a little

6 bit. I don't think the distinction between

7 old and new is very clear.

8 I think using terms like new and

9 recent that are kind of used conversationally,

10 and going back and forth between which term

11 you use, knowing that no one other than Jon

12 Samet is going to read the whole thing, is

13 really not going to make sure that people know

14 what we're talking about.

15 So I mean, I think you can even be

16 explicit to say, you know, define what new and

17 recent mean, maybe several times. Or to say

18 this section of study since the last review. 

19 Or somehow be really explicit about it.

20 But still, I would personally like

21 to see mention of some of the key studies from

22 before that we're using for scientific
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1 evidence. But certainly not every study.

2 But, you know, as long as the

3 document is, when you tell people to go back

4 and read the 1986 document. I mean it's

5 really even longer --

6 DR. SUH: Yes, but I don't think

7 that's what the document's -- I agree with

8 you. Maybe the key studies is the thing to

9 do. And maybe that's like put in a box in the

10 front or something. I don't know exactly.

11 But I think it is a presentation

12 kind of thing. I think we're in agreement

13 about, you know, about the issues. I think

14 it's just really a presentation.

15 But I think you can't, just as you

16 can't omit all of what's known before, you

17 also I think have to, for the document itself,

18 include what is different from last time.

19 DR. SUH: Yes.

20 DR. SAMET: Okay. Judy's got a

21 comment. And I think, John, if you have any

22 comments. And then we're going to take a

Page 359

1 break.

2 DR. GRAHAM: Yes. And, Helen, I

3 can agree with what you said. I'd like to

4 fine-tune it. The problem is that now all the

5 new studies are just studies there because

6 they're new.

7 They're not new ideas. They're

8 not perfections of like, which cigarette, or

9 an additional mechanisms. They're just plain

10 new.

11 And so if it were, you know, we

12 have all this whole body of evidence here, and

13 here's something brand new that has an effect,

14 makes it stronger, or whatever, then that

15 would be okay. But right now, the worship is

16 pretty much at the date.

17 DR. SAMET: John, any comments or

18 --

19 DR. VANDENBERG: Well, I think

20 very clearly we're seeking advice. And what

21 I'm hearing is quite a range of views. I

22 would tend to offer that the approach we've

Page 360

1 taken is very consistent with what Dr. Vedal

2 and Suh suggested, which is we provide some

3 context of the review of the prior body of

4 research.

5 Perhaps we don't get into the

6 specificity that some would like. And I can

7 understand that point of view. But we have

8 focused more on the newer studies since the

9 last review in order to actually streamline

10 the information. To focus on the newer

11 information.

12 It doesn't mean the old

13 information isn't highly relevant. It clearly

14 is. And perhaps there may be some advice you

15 could provide as to how to effectively bring

16 that in without bringing perhaps an

17 overwhelming amount of information in.

18 Because the body from before if

19 you recall, this is a streamlined ISA compared

20 to the former air quality criteria document. 

21 So we have to be mindful, and we appreciate

22 your advice as to how to do that most

Page 361

1 effectively, to bring perhaps the key or the

2 most informative studies forward in an

3 effective way.

4 DR. SAMET: Okay, Joe is last

5 word.

6 DR. BRAIN: I think the key issue

7 is this is a five-year review. How have the

8 views of the EPA and of CASAC changed? And so

9 I think, you know, it's not so much new or

10 old.

11 But I think that's what the

12 Administrator, and that's what the community

13 and the ATS wants to know is, do we have new

14 ideas about ozone and what the standard should

15 be?

16 And then to carefully select the

17 references that support the way views have

18 evolved. That may be reinterpretation of old

19 studies. Or it may be a brand new study. And

20 so we don't put something in simply because

21 it's new. But we emphasize the ones that have

22 altered our perspective.
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Page 362

1 DR. SAMET: Okay. So it is

2 roughly 20 after. We're behind, but I think

3 we're okay. We actually have a lot of time

4 set aside at the end for discussion of

5 Chapters 1 and 2, and may not need so much. 

6 So why don't we take a 15-minute break. Get

7 back here about 25 of.

8 (Whereupon the foregoing matter

9 went off the record at 3:22 p.m. and resumed

10 at 3:36 p.m.)

11 DR. SAMET: Okay, we are at

12 Chapter 8, At Risk Populations. Ana.

13 DR. DIEZ-ROUX: Okay, can you hear

14 me? Okay. So I'm going to talk about Chapter

15 8. First I should say, I think this is a very

16 important chapter.

17 It's a complex topic for a number

18 of reasons that have to do with some of the

19 concepts and terminology, as we'll discuss. 

20 And also because some of the evidence is very

21 difficult to summarize. But, nevertheless, I

22 think it's a very important chapter.

Page 363

1 I was not part of the prior

2 review, but my sense from reading the prior

3 comments is that EPA has really tried to

4 incorporate many of the suggestions that were

5 made in the prior review regarding terminology

6 and laying out things at the beginning.

7 And I think the chapter has been

8 moving in the right direction. However, as a

9 new reader, I have some additional comments

10 that I hope may be useful in further

11 clarifying some of those issues.

12 So I'm going to make some

13 comments, some more conceptual comments in

14 terms of clarifying exactly what the chapter

15 is focusing on and what it's trying to do.

16 And then talk a little bit about

17 some of the framework and the way it's laid

18 out, and then talk a little bit about some of

19 the content. Okay?

20 So in terms of the concepts, I

21 think it's very important for this chapter to

22 clearly, and it's starting to do this, but I

Page 364

1 think it could be clearer, to clearly

2 distinguish two processes that place certain

3 populations at, quote, increased risk.

4 One has to do with simple

5 increased exposure. And that can be because

6 people are exposed to, you know, higher

7 ambient levels because of where they live, or

8 because they work outdoors. Or it can be

9 because they receive a greater internal dose

10 for a given ambient exposure because of

11 breathing patterns or because of air

12 conditioning or whatever.

13 The latter is manifested as effect

14 modification in epidemiologic studies, but

15 it's really just increased exposure, or

16 increased internal dose. So that's one set of

17 processes.

18 The other set of processes, which

19 is, I think, what the bulk of the chapter

20 focuses on, is processes that lead to a

21 greater adverse health effect of a given

22 exposure or a given dose. And that's what

Page 365

1 appears in studies as effect modification or

2 statistical interaction.

3 Although, as I noted before, some

4 of the internal dose variations can also

5 appear as effect modification, but they're a

6 different phenomenon. So I would keep them

7 with the increased exposure.

8 In terms of a greater adverse

9 health effects of a given exposure or dose,

10 there are a number of factors that can lead to

11 that, as you have them in the chapter. They

12 can be from very proximal things like genetic

13 factors, to individual level behaviors like

14 nutrition, to social processes.

15 Now, my sense is that you're using

16 the term population at risk to encompass both

17 of those things. And if so, I think it can be

18 more clearly stated at the beginning of the

19 chapter.

20 And decide if you are going to use

21 the terms vulnerability, susceptibility or,

22 you know, sensitive populations et al., or
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1 not. If you are going to use those terms,

2 then I think you need to clearly define what

3 they are.

4 Are they synonyms of population at

5 risk, and therefore encompass both processes? 

6 Or are they referring specifically to the

7 second part, which is the greater adverse

8 health effects of a given exposure?

9 I think a lot of times,

10 sensitivity or vulnerability is used in that

11 way. If that's the way it's going to be used,

12 then that needs to be defined.

13 And I think it's important to be

14 very consistent in the terminologies

15 throughout the whole document, because even

16 though this chapter talks about population at

17 risk, there are numerous instances throughout

18 the both volumes using, like, sensitivity as

19 a synonym for greater adverse effects of a

20 given dose.

21 So I think that needs to be

22 clarified, and the terms very clearly defined.

Page 367

1 I know there's a history, you know, to this.

2 But these are just my comments as a first-time

3 reader of this document.

4 So that's the more conceptual

5 piece. I think this conceptual layout can be

6 reflected in the structure of the chapter.

7 So, for example, you could talk

8 first about factors that are related to

9 increased exposure, and perhaps that section

10 can be brief, so the piece that you have on 

11 heightened exposure, for example, can be part

12 of this. And then, talk about all the factors

13 that increase the adverse health effects of a

14 given dose.

15 In talking about those factors,

16 you know, one way, and this is just

17 reorganizing material that you already have,

18 but the way it is now, you're talking about,

19 you know, one thing here and then you're

20 jumping to another, genetics and behavior and,

21 one way that you could reorganize it is go

22 from more proximal to more distal effect

Page 368

1 modifiers, because some of the more distal

2 factors like race and SES really operate

3 through behavioral stuff. For example,

4 through more proximal mechanisms. So this is

5 not a very big point, but just reorganizing

6 it, I think, would help the flow.

7 In terms of the content, when you

8 talk about each of the sections, it talks

9 about each of the, I'm going to call them

10 effect modifiers, or each of the factors that

11 modify, that increase the adverse effects of

12 exposure. I think it's important, and you do

13 this to a certain extent, but to

14 systematically start out with our rationale

15 for why we would expect effect modification.

16 And this could allude back to some

17 of the other chapters. You know, for example,

18 to the chapter that we discussed earlier, I

19 think it was 4 or 5, which talks about, you

20 know, more biological mechanisms that could

21 result in differential effects.

22 So give a rationale for why we

Page 369

1 would expect some effect modification. Give

2 some information on the prevalence of the

3 condition or factors so that readers can get

4 a sense of, well how important is this at the 

5 population level.

6 Review the epidemiologic evidence

7 and review the controlled experiments and

8 toxicological studies as you do. Now, then

9 have a general conclusion.

10 So it would be nice for each of

11 these sections to be very parallel in that. 

12 And I think you do that to a certain extent.

13 I think a little bit of cleaning up of that

14 would help.

15 One thing that I found was that

16 sometimes the way the literature was reviewed,

17 it was difficult to get a sense of, well what

18 is the bottom line. How much evidence do we

19 really have that this is an effect modifier?

20 It read a little bit like, well,

21 there's this study and then there's that

22 study, and then there's this one. So it was
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1 a little bit hard to conclude much from the

2 way it was set out.

3 And perhaps the conclusion is that

4 we can't conclude much. But then it has to be

5 clear.

6 So for example, one thing to

7 consider is whether it might be useful to have

8 some schema, just like, you know, we have some

9 guidelines for causal inference, to have some

10 guidelines for saying, well these are effect

11 modifiers that are well-established. Or these

12 are suggestive, but need to be studied

13 further, and there's no evidence that these

14 things so far modify.

15 I don't know, it would be

16 interesting to think about whether that could

17 be done in some way. And that would allow it

18 to connect, also, to other documents.

19 Like the subsequent documents that

20 are coming that, you know, I assume some of

21 this stuff on population at risk is carried

22 forward potentially into the other documents,

Page 371

1 the more policy and the risk assessment

2 documents.

3 And so it would be nice to be able

4 to have some, well what's the bottom line

5 clear conclusions that we can draw about

6 populations at risk that need to be carried

7 forward. The way the chapter is now, it's

8 hard, that doesn't really come through.

9 And as a final point, I think it

10 would also be important for the chapter to

11 acknowledge that, specifically a topic of

12 looking at effect modifiers. You know, it's

13 quite complicated to do in studies.

14 Now this is where, maybe one of

15 the reasons why we have inconsistent evidence.

16 They're issues related to, you know,

17 comparable measurement of effect modifiers. 

18 Sample size is a big, big problem.

19 So acknowledging some of the

20 challenges in studying these effect modifiers

21 and looking at replicability and genetic

22 stuff. Replicability: big, big issue.

Page 372

1 And perhaps some of the text that

2 you have on the healthy responders, which

3 really talks about unexplained inter4 individual variability and response could be

5 incorporated into that.

6 So, for example, we know that

7 there's a lot of inter-individual variability.

8 There must be some factors that explain that. 

9 But we still haven't been able to identify

10 them for these, you know, number of reasons.

11 So I think that sets the stage for

12 why this is an important topic, even if we

13 don't have a lot of evidence yet to be able to

14 draw, you know, very, very firm conclusions

15 about these factors.

16 I think that's about it. Yes, I

17 think those are my main comments.

18 DR. SAMET: Okay, thanks. Judy?

19 DR. GRAHAM: I would like to

20 strongly endorse what Ana just said. And one

21 caution there is when we talk about, you know,

22 what would cause there to be a greater adverse

Page 373

1 effect, I think it will also slash impact.

2 And that brings up the issue of

3 sometimes here we talk about, say a chronic

4 bronchitic, or smoker may be less responsive.

5 But it could be that same small change in

6 pulmonary function might have more of an

7 impact because they have less reserve

8 capacity.

9 I like the separation as exposure

10 to really strongly bring exposure in here. 

11 It's not treated properly. Dose is not

12 discussed, exercise is not mentioned. Kids

13 being outside during the height of the summer

14 day is not mentioned.

15 So the focus seems to be on

16 outdoors. And yes, outdoors is there, but

17 outdoors is important because exposure is

18 outdoors. It's not -- outdoors per se is not

19 important.

20 So I think there needs to be a

21 rethinking of what exposure factors come in

22 here. And then the difficulty is doing some
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1 intertwining, because in come cases, a given

2 individual will have a greater adverse effect

3 to a given dose. But that person may also

4 have a greater dose. In which case, that

5 group is even of higher concern for health

6 risk.

7 I do very, very much like the term

8 at risk that you put in here. And the reason

9 I like it so much is the Clean Air Act of 1970

10 used the words sensitive sub-populations. 

11 Well, what's sensitivity?

12 So, I mean, I define sensitivity

13 in a very narrow way. In fact, the way you

14 narrowly defined it here. But by saying at

15 risk, you basically create this umbrella.

16 And what it is, who should we care

17 about? What population groups need to be

18 protected? And so it's going to be very

19 important.

20 I also believe that changes that

21 you make in the earlier chapters that are

22 supportive of this are going to be quite

Page 375

1 helpful.

2 The other question I might have

3 for you to give some discussion space to is,

4 I didn't read all the epi -- I just scanned

5 parts of it, so maybe this discussion is

6 there, I just didn't read it. But that's, how

7 do we use the epi studies conducted in foreign

8 countries compared to the U.S. situation?

9 So, let's take the case where we

10 have a perfectly terrific epidemiology study

11 in China. This is what I'm focusing on

12 because, like low SES in China had more of an

13 ozone effect.

14 Well, how's that low-SES group

15 compared to a U.S. low-SES group? There's all

16 sorts of international cultural differences or

17 even pollutant mixture differences.

18 So again, I apologize if it's

19 there, may be in a place I didn't read it. 

20 But to discuss how do we use this kind of

21 information? So, that's all.

22 DR. SAMET: Okay, Steve.

Page 376

1 DR. KLEEMBERGER: So, again, like

2 Judy, I think, you know, those comments nicely 

3 summarize some of the things I was thinking

4 about as well. I think the reorganization is

5 helpful, and I put that in my written

6 comments.

7 What I will suggest, though, and

8 Ana touched on this is that -- and we

9 discussed this earlier this morning -- is that

10 the summary, the synthetic part moving forward

11 was missing. I felt like there was a lot of

12 summaries but there was no sort of putting it

13 all together, what does this mean.

14 And I think some more work needs

15 to be put into that. I think some strength of

16 evidence, if you will for some of these risk

17 factors could be put into a table that would

18 make it easier for the reader, and whoever

19 else views this document to sort of come up

20 with a conceptual sort of, okay, so how

21 important are these factors, really?

22 And so I think that would be

Page 377

1 something I would recommend. I'm going to

2 speak a little bit to the genetics now. So

3 one of the points that I think needs to be

4 made as far as the genetics are concerned is

5 that ozone, as we've heard throughout the day,

6 causes lots of effects, adverse effects.

7 And at least as far as the

8 literature is concerned, it's pretty clear

9 that there are potentially different genes

10 that control these different responses.

11 So the pulmonary function response

12 genes, if you will, may be different from the

13 inflammation response genes. The cell

14 inflammatory response genes may be different

15 from the increased vascular sort of leakage

16 genes.

17 And so, you know, because of the

18 inconsistencies that you see across studies,

19 I think part of the reason these

20 inconsistencies may occur is because you're

21 probably looking at the same gene for all

22 these responses.
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1 Well, it's probably not that

2 simple. In fact, I'm sure it's not that

3 simple. And so these are very complex sort of

4 systems and that didn't come out in my

5 reading.

6 And if you want to include a

7 phenotype as O2 uptake or dosimetry, you know,

8 the genetic literature on that is nearly

9 completely nil. I don't think that there's

10 anything that has been done, aside from one

11 study by Gary Hatch a couple years ago that

12 looked at, I think, two or three different

13 strains of mice, and looked at the O-18 uptake

14 with exposure and found that there were

15 differences between strains. But it didn't

16 take it any farther than that.

17 These are important studies that

18 need to be done. And I think that point can

19 be made, too. I think there was lots of

20 important studies that should be done that

21 haven't.

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

Page 379

1 our purview to do that, but I think making

2 those recommendations in the document, I think

3 is very important. I think that's all I have

4 to say.

5 DR. SAMET: Steve, could you

6 comment on the material in Chapter 5? There's

7 some discussion of genetics there, as well,

8 versus Chapter 8. And should it be brought

9 together?

10 DR. KLEEMBERGER: Oh, the gene11 environment interaction kinds of things? 

12 Actually, I think it's probably fine as is.

13 I guess I don't feel strongly

14 either way. I think it's fine as is, but I

15 could also see where you might want to lift

16 that and put it into the other.

17 DR. SAMET: It sort of made sense

18 for me to bring it together in one spot.

19 DR. KLEEMBERGER: Again, I don't

20 feel strongly either way.

21 DR. DIEZ-ROUX: The same applies,

22 I think there's a discussion of nutrition as

Page 380

1 a modifier in Chapter 5, as well. And this is

2 highly relevant to the mechanisms in this

3 chapter.

4 So I think you need to decide

5 where is that going to be discussed more in

6 depth, and the other place can just refer to

7 it.

8 DR. SAMET: So, others want to

9 comment on this chapter? Yes, Fred.

10 DR. MILLER: I have three quick

11 comments. It's late in the day, and I'm glad

12 that the EPA authors are interested in sex. 

13 But I really think that 816, it should be

14 gender, not sex as the subsection title, if

15 we're going to sort of be a little bit more

16 sensitive.

17 Some people think I'm sexist, I

18 guess. I don't know. At any rate, I just

19 think it should be changed to gender rather

20 than sex as the title for the section.

21 But there's a study that's cited

22 here in California on poverty levels, when you

Page 381

1 get into the SES. And I bothered to go get

2 the study and read it.

3 And they talk about greater

4 effects when you have less than seven percent

5 in terms of the SES level and between it. 

6 There was absolutely zero in that paper as to

7 how they picked those levels.

8 And I feel almost 100 percent

9 certain it's the same as the Von Neiding NO2

10 studies 35 years ago that, that after the fact

11 went and divided them into responders and non12 responders.

13 There is zero in here on

14 justification for how they created those SES

15 categories. And I would throw that paper out.

16 I mean, if you get that kind of

17 paper published without an explanation of your

18 methodology, then I got to really worry about

19 the journal. So, I think you should take a

20 look at that, because it just doesn't stand

21 up.

22 And the last comment has to do
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1 with exercise that -- didn't exercise at all,

2 and a statement here on page 826 where it

3 compared to those that exercised at least once

4 a month.

5 Okay, now is that a typo? I mean,

6 because, you know, please don't talk to me

7 about being able to delineate zero versus one

8 exercise a month.

9 I've gotten into a heavy physical

10 exercise activity and lost 30-some pounds

11 recently. You know, and I'm going five days

12 a week. And I'm telling you, you know here

13 this one exercise once a month. And in fact,

14 there's other studies that show if you only

15 exercise on the weekend, you're at greater

16 risk for cardiovascular. So give me a break

17 about some of these things.

18 And the kind of scrutiny for some

19 of the stuff in here, I think needs to be

20 elevated.

21 DR. SAMET: Well, I don't want to

22 disagree with you, Fred, about sex. I think,

Page 383

1 in fact, if you refer to the XY chromosome, it

2 is sex, and if you're referring to choice or

3 preference, it's gender.

4 So I actually think sex may be the

5 right word here. I would defer to any other

6 expert on sex and gender around the table. 

7 But, I think I've got it right.

8 DR. DIEZ-ROUX: Sex is usually

9 used when you are referring to biological

10 factors that have to do with hormonal or

11 chromosomal stuff, whereas gender's a broader

12 concept.

13 DR. MILLER: So sex is divided to

14 male versus female responses. So isn't that

15 gender?

16 DR. DIEZ-ROUX: Depends, it could

17 be both, actually. It depends on what the

18 mechanisms that they're talking about are. If

19 they are mostly biological, then it should be

20 sex.

21 DR. MILLER: All right. I

22 probably brought it up just to kind of lighten

Page 384

1 the end of the day, but okay, whatever.

2 DR. SAMET: He succeeded. Helen.

3 DR. SUH: It's just a quick

4 comment. Reiterating what Judy said, I think

5 in the front part of this chapter there was a

6 discussion about evidence from which chapters

7 were included and it didn't mention exposure.

8 But exposure's so relevant to the

9 chapter that I think it should be very

10 explicit inclusion. And then, you know,

11 especially when they talk about things like,

12 you know, the more exposed, I forgot what it

13 was called, highly exposed -- heightened

14 exposures and things, so I think it has to be

15 called out that explicitly that you drew on

16 results from that chapter.

17 DR. SAMET: Anybody else?

18 DR. MILLER: There's still a

19 little confusion, as you said, between

20 exposure and dose.

21 DR. SUH: Yes, I did have to say,

22 I thought it was very elegant, the way you

Page 385

1 dealt with the susceptibility and

2 vulnerability. I thought that was very nice,

3 actually.

4 But, there is still a lot of

5 confusion. Even with that, there is a lot of

6 confusion and overlap. But I did think it was

7 a very clever way to skirt the issue.

8 DR. SAMET: I think a couple of

9 the big-picture comments, the reiteration --

10 and one is up front description of processes,

11 which you took a step towards doing. I think

12 we could do it better and more fully.

13 And it would probably be useful to

14 get it done well. I mean, there's always a

15 Chapter 8 or a chapter on at risk populations,

16 and I think there's been a lot of struggle,

17 and some evolution in your approach to this.

18 But to even draw out what these

19 processes are, I can think of lots of pictures

20 to illustrate them. Modifiers of dose given

21 exposure. I mean, there's lots of ways you

22 could show this, and I think you could expand
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1 what's up front.

2 I think a couple of paragraphs on

3 the difficulty of investigating, you know,

4 effect modification, whatever you want to call

5 it, would also be useful. And I think the

6 determination of whether there is or is not

7 effect modification is very often rather ad

8 hoc.

9 And I think to the extent that you

10 could say, here's how we approached assessment

11 of this, I mean there are a few extreme

12 examples where there's no question, but very

13 often the information is a little bit soft.

14 And I think if you said that, and

15 then you could come up with some sort of, you

16 know, a couple of descriptors that you used

17 consistently, very simple, that that would be

18 a real step forward.

19 I have one other comment to Judy,

20 I think it's probably, we're going back to our

21 child -- that if you think that kids are out

22 at midday playing in the heat of the sun, I

Page 387

1 think they're indoors playing video games. 

2 But, maybe somebody more contemporary could

3 update me.

4 FEMALE PARTICIPANT: Once a month.

5 DR. SAMET: Yes. Out with Uncle

6 Fred. Okay, anything else on this? Okay,

7 thanks.

8 So let's go on, at last. The

9 group's waiting patiently hearing all this

10 human health stuff, waiting to get to the real

11 thing.

12 DR. WEATHERS: Okay, I think the

13 gender-free chapter. So I thought what I

14 would do is give some overarching comments

15 about this chapter based on what it is that I

16 read of David and Howard's comments.

17 I didn't see any from Peter. I'm

18 not sure if there are any coming. Most of

19 mine have to do with specifics and not the

20 overarching pieces. And then I'll have you

21 guys chime in.

22 So I think it's fair to say that

Page 388

1 we all that the EPA has captured well and

2 responded appropriately to our issues of

3 concern last time around. None of us

4 identified, at least in our written comments,

5 any major changes that were necessary.

6 And that's probably not surprising

7 since most of the conclusions are also

8 supportive of the 1996 and 2006 conclusions.

9 We actually just had a quick

10 conversation as we were talking about

11 integration of the new and old data. And I

12 think we three think that this chapter did it

13 quite well. So this is a good example, I

14 think, for integrating the old and the new.

15 The last section, the summary and

16 summary table, I thought, anyway, were

17 particularly good, and quite useful and

18 integrative, as well.

19 And I certainly appreciated the

20 identification of future needs in many of the

21 summary sections. I think that that's a

22 useful piece of information to capture.

Page 389

1 There were a few challenges, I

2 think that were overarching. As with many of

3 the other chapters, there's some sections that

4 still could use some technical editing, and I

5 think David and I both commented on that.

6 There's certainly some confusion

7 still about how scale is used and even, from

8 my perspective, how ecosystem is used. And it

9 would be helpful to add definitions and

10 explanations for some of the terms in my world

11 of being a frustrated accountant.

12 It's the accounting terms like

13 defining gross primary production and that

14 ecosystem production and respiration and the

15 relationship among all of those. And it

16 becomes quite relevant when comparing model

17 results for ecosystem responses to ozone.

18 But there are some in the

19 vegetation and the community and population

20 scale, too.

21 And there was a comment earlier

22 today, and I don't know if we want to take up 
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1 or not about some opportunities to contrast

2 and compare plant and human exposures and

3 responses.

4 And so I throw that out to our

5 group and to the rest of the group as, is

6 there something that might be done there. And

7 I would think that it would be in the front

8 materials where it might be done. So those

9 are overarching comments. David?

10 DR. SAMET: Okay, David?

11 DR. GRANTZ: I guess I would start

12 out by saying that I really do feel like staff

13 listened very carefully to the things we said.

14 And as I read through this chapter, I was

15 really very, very pleased.

16 I think there were some problems

17 before, it reads much better now. Things are

18 more consolidated along the lines that we

19 suggested.

20 I had a couple of points that I

21 think, mostly I had mentioned before, and I

22 think weren't taken up. One is this business

Page 391

1 of sensing ozone. I am just not convinced

2 there's an ozone sensor. There's a cascade of

3 oxidant impacts.

4 But there is no ozone sensor. And

5 that comes up several times, at least. So I

6 think that should probably be reworked a

7 little bit.

8 We did have a discussion, the

9 three of us, on this business of old versus

10 new. And I do think, mostly, the chapter does

11 a good job. But I think I differ a little bit

12 with Howie and Kathy on, there are numerous

13 times where it's stated that in the previous

14 criteria document, this was discussed, rather

15 than, these are the conclusions upon which we

16 build the rest.

17 And it's just, you know, it's

18 textual laziness, basically. But I think you

19 should go back through and look for those

20 places, because this document really does have

21 to stand alone. I don't want to go find the

22 old CD.

Page 392

1 You know, you don't have to cite

2 all the studies. You should certainly cite

3 the conclusions that you're going to use.

4 I think EPA did a really nice job

5 of corroborating the old open-top chamber data

6 that's elaborated upon in some detail. And I

7 think that's just critically important, as I

8 think we all said the last time around.

9 And then the only other thing that

10 I want to emphasize from my written comments

11 is this business of ozone impacts on root

12 growth. And I say specifically in my written

13 comments that the conclusions in 9431 and 9432

14 are very, very weak considering how well we

15 really know that ozone impacts allocation

16 below ground. I mean, the meta-analysis that

17 we published in 2006 pretty well establishes

18 that for a large number of species. And yes,

19 of course, there are some studies that don't

20 find it. There may even be some species that

21 don't exhibit it, although I doubt it, but

22 there may be.

Page 393

1 But overall, it definitely does

2 impact carbon movement below ground. Now, in

3 those sections, the question is whether we can

4 demonstrate reduced sequestration of carbon

5 below ground. And that is a separate

6 question, and it should be kept separate.

7 Now, reference is made to the

8 Rhinelander, Wisconsin study wherein at some

9 time point during the five or six years, an

10 actual increase in fine roots below ground was

11 observed.

12 But as you note, that was a

13 community level response. It doesn't negate

14 the fact that ozone really does inhibit carbon

15 movement below ground.

16 What you're claiming is that if we

17 can use ozone to drive sensitive species out

18 of the population, that we'll get more carbon

19 below ground. Well, that's not a direction

20 you want to go.

21 If you want to explain community

22 level and population change impacts on any
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1 endpoint, including carbon sequestration,

2 that's fine. But I think you should do that

3 explicitly. I think you missed the point

4 there a little bit.

5 And the rest of it, I think is in

6 my written comments. Thank you.

7 DR. SAMET: Howard?

8 DR. NEUFELD: Well, being the

9 third person in a row, much of it's been said.

10 But again, I want to compliment you on the

11 revision of this chapter. Almost every

12 comment I remember making on the previous one

13 has been addressed in this revision. So it's

14 done very well.

15 So, I'm just going to go through

16 real briefly what I wrote here. Just a few

17 things. On page 9.3, you state that there

18 have been really no methodological

19 advancements since 2006 that have

20 fundamentally altered our understanding of

21 ozone effects on plants and ecosystems.

22 I think that's a little too

Page 395

1 strong. I mean, we haven't had much funding,

2 and sure, there isn't a lot of breakthrough

3 technologies, but there's been a few.

4 Like Nancy Grulke's apparatus to

5 simultaneously measure gas exchange while

6 supplying ozone to leaves, that is a

7 methodological advancement because that's a

8 very technically difficult thing to do.

9 I was really pleased, as David had

10 mentioned, about your pulling together the

11 exposure responses from plants done in a

12 variety of different ways, like in CSTRs and

13 open top chambers and so on. I think your

14 analyses clearly show that the results from

15 those early studies still have a lot of

16 relevance.

17 And in that, there was a lot of

18 internal consistency among these various

19 exposure methodologies. I think that's an

20 important point that you made.

21 And also, when you were discussing

22 the results of the open top chambers and face

Page 396

1 and gradient studies, you mentioned the

2 possibility of chamber effects when you're

3 using open top chambers.

4 And indeed, many people do find

5 them, but there's also many instances where

6 you don't. I list some in my written comments

7 here where we specifically looked at a chamber

8 effect and either found very few effects or

9 none at all. So that the results from the

10 open top chamber studies seem to be quite

11 valid.

12 I particularly liked the section

13 on page 921 when you started to discuss

14 proteomic and transcriptomic studies. They

15 were well done.

16 This is a relatively new area of

17 research in the ozone area, and you got the

18 major patterns out there in a nice, readable

19 way, especially for those of us who are not

20 molecular biologists.

21 And I just want to ask you a

22 question to colleagues here on the other side

Page 397

1 and all over here. I couldn't find any

2 mention of similar studies done on either

3 animals or humans. So is that because there

4 aren't any, or did I miss it? So I just throw

5 that out as a question.

6 MALE PARTICIPANT: What kind of

7 studies?

8 DR. NEUFELD: Like arrays, you

9 know, what genes are up-regulated and down10 regulated upon exposure to ozone?

11 DR. KLEEMBERGER: In the animal

12 literature, there's a lot.

13 DR. NEUFELD: Is there?

14 DR. KLEEMBERGER: Yes.

15 DR. NEUFELD: Okay. All right. 

16 Is it in this document? That's what I was --

17 DR. KLEEMBERGER: One paper is.

18 DR. NEUFELD: Yes, well anyway, I

19 just point that out. In section 9.4.2, I

20 think you could maybe just beef up the

21 discussion a little bit on genetic variation

22 to ozone in non-crop species.
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1 For example, there's Somers, et

2 al., and Chappelka, et al., and Souza et al.,

3 which show a lot of genetic variation in

4 herbaceous and woody plants in the native

5 plants as opposed to crop plants.

6 The meta-analysis that Wittig et

7 al. did in 2009 shows a seven percent

8 reduction in growth with ozone as low as 40

9 parts per billion. Perhaps that's worthy of

10 a little more discussion because they say in

11 their paper that they expressed that relative

12 to growth in charcoal filter controls.

13 So, given the discussion we've had

14 here about background ozone and the use of

15 charcoal filter controls, maybe that section

16 needs to be looked at again. In all the tree

17 studies I did in the Smokies, we didn't find

18 any measurable effects on growth at ambient or

19 below.

20 I was pleased to see that you

21 included the lower plants, like mosses and

22 lichens. They may be small in stature, but

Page 399

1 they cover a large portion of the earth.

2 You refer to the trees and the

3 AspenFACE site at Rhinelander as a forest in

4 Wisconsin. Every single one of those trees

5 was planted and there are, maximum, only three

6 different species in the mix diversity forest. 

7 So I think you should refer to it as an

8 artificial or planted forest.

9 And in the summary, 9.4.3.2, the

10 last paragraph, you might consider modifying

11 the conclusionary sentence. I think it's

12 important to stress that many ozone effects on

13 native vegetation in the field have been found

14 at ambient levels, which would distinguish

15 those effects that are found at elevated ozone

16 under controlled conditions.

17 And lastly, I was pleased to see

18 you discussing sluggish stomata. This is a

19 fairly new response. But you suggested in

20 there, in the writing, that that could lead to

21 greater water loss.

22 And I want to just point out the

Page 400

1 possibility that it could actually, maybe end

2 up not, because by the time the stomata

3 becomes sluggish, they may have partially

4 closed to a great deal, so that they're

5 actually letting off less water.

6 So you might actually get less

7 water loss, even though the stomata have

8 become unresponsive to changes in the

9 environment. So maybe you could just slightly

10 modify that section.

11 And the rest, I would say is well

12 written, and good job. Thanks.

13 DR. GRANTZ: Okay, I had one --

14 DR. SAMET: Yes, sure.

15 DR. GRANTZ: One thing that I

16 forgot to say, I think the emphasis on

17 photosynthesis, which is one of the earliest

18 effects that we knew about, is well founded.

19 And I think that's important.

20 There's a lot of recent work on

21 stomatal conductants and the document

22 accurately says there can be direct and

Page 401

1 indirect effects on stomata. But the indirect

2 effect is entirely by intracellular CO2. And

3 I think that's wrong.

4 You know, we know that abscisic

5 acid, for example, defuses from the mesophyll

6 and impacts stomatal conductants. There's

7 probably a lot of that going on.

8 So to focus solely on CO2 and to

9 call that out is probably just -- simply can

10 be deleted. I don't think you need to even go

11 there.

12 There are definitely mesophyll

13 effects on guard cells and there are direct

14 ozone effects on guard cells. And we don't

15 know very much about either one.

16 DR. SAMET: Okay, comments from

17 others. Sverre? That's a no. Okay, any

18 comments from others on this? Yes?

19 DR. MILLER: I got a quick one,

20 you win the award for the most references, 33

21 pages. But yet it's not the longest in text.

22 So obviously it was very well
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1 written. And maybe that's an example for

2 others to follow in some of the, like 6 and 7?

3 DR. WEATHERS: Yes, what I was

4 saying was that there are some great tables,

5 synthetic tables in this chapter, to be

6 commended.

7 DR. SAMET: Good, got your praise. 

8 I will say in reading about the early days of

9 air pollution in L.A., the effects on

10 agriculture were extraordinary. I mean, it

11 caused a revolution in what people were doing,

12 thinking, raising. If I've got this story

13 correct, probably still does.

14 Okay, good. Thanks. So I guess

15 we can move on and we just almost caught up.

16 Let's see, so then we're up to the Chapter 10.

17 DR. JACOB: All right, so Chapter 

18 10 is about global perspectives involving

19 ozone as a climate gas, and also UV effects.

20 And it's a much shorter version from what was

21 in the first draft of the ISA.

22 And overall, I think it's all

Page 403

1 right. I have a number of comments that are

2 in the written record and I'll edit them. But

3 I wanted to just hone in on three issues,

4 which I think are important.

5 The first one is that this chapter

6 misses an opportunity to more clearly state

7 how emission controls, relevant to ozone

8 pollution, will impact climate change. 

9 There's a lot of discussion of this in the

10 latest IPCC report, which was, you know, out

11 in 2007.

12 The message is actually fairly

13 complicated. For example, NOx emission

14 controls are thought to be climate-neutral

15 because of cancelling effect. CO and VOC

16 emissions are, emission control is very

17 expected to have a climate benefit.

18 But the most important climate

19 benefit to have is, of course, reduction in

20 methane emissions, which also will have an

21 effect on ozone pollution. There are charts

22 on this in the IPCC report. Bar charts that

Page 404

1 I think would be very useful to include in

2 this chapter.

3 In particular, there's a bar chart

4 in the IPCC report that shows that over a 20-

5 year horizon, methane emissions are more

6 important in terms of warming than CO2

7 emissions, which is something that's really

8 interesting.

9 And as EPA goes more and more into

10 trying to meet both air quality and climate

11 objectives, methane definitely needs

12 consideration. And I think this could be more

13 prominently advertized in this chapter.

14 That's comment number one. And

15 also the fact that NOx emissions are climate16 neutral.

17 Comment number two has to do with

18 future emission projections. There's a

19 general tendency in this chapter to say that,

20 well the situation with global tropospheric

21 ozone is likely going to become worse. In

22 particular because of increasing emissions in

Page 405

1 Asia, and so on.

2 Well, that was the message one

3 could have gotten from the last IPCC report.

4 But the upcoming IPCC report, AR5, is going to

5 show a very different pictures.

6 And in particular, the emission

7 scenarios for the 21st century, which had not

8 been updated since 2001, the third IPCC

9 report, will be totally changed. We won't

10 have the SRES scenarios anymore. We will have

11 the RCP scenarios.

12 And this is already published in a

13 variety of documents and a very important

14 feature of those RCP scenarios is that the

15 emissions of ozone precursors on the global

16 scales are all going down.

17 Emissions of NOx are going down. 

18 Emissions of CO are dropping like a rock. 

19 Emissions of VOCs, also emissions of methane

20 are becoming flat and then going down.

21 The point is that if you run these

22 RCP scenarios for a model, you will find that
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1 global ozone is going to be going down in the

2 coming decade. So a very, very different

3 message then what we've had in the past, and

4 what is still reflected in this chapter.

5 So I think this needs to be

6 changed, because it has very important

7 implications for what we think about in terms

8 of ozone as a climate gas and also in terms of

9 intercontinental pollution, which is not a

10 really topic of this chapter. But still, I

11 think that message needs to come across.

12 Finally, the last important point

13 I want to make is about ozone in terms of it's

14 impact on UV-B at the surface. This is

15 actually a very simple problem. This is a

16 simple radiative transfer calculation.

17 And it seems to me that this

18 chapter could be more conclusive about the

19 fact that the effect is really very, very

20 small. It cites a study done by Sasha

21 Madronich which did a radiative transfer

22 calculations for emission control strategy,

Page 407

1 concluded that the effect is very, very, very

2 small.

3 And then it cites a few field

4 studies that show that the effect is

5 insignificant.

6 But then, at the end of the

7 chapter, the conclusion is that, while the

8 effect is expected to be small, it cannot yet

9 be critically assessed within reasonable

10 uncertainty.

11 Well, I don't think that's

12 correct. I think we can be a little bit more

13 direct and say the effect is very small. So,

14 that's a summary of my comments.

15 DR. SAMET: Okay, thank you. Ted?

16 DR. RUSSELL: Just to pick up from

17 what Daniel said is that my thought on the

18 section on the UV impacts on human health was

19 that, even though it wasn't that many pages,

20 you know 10.4.5, whatever, it still was

21 rambling.

22 And it seemed like you were trying

Page 408

1 not to get to a point of being a bit more

2 quantitative. And I would go beyond what

3 Daniel said about it's very small, give me an

4 idea of how small it is, because I think you

5 probably can do that.

6 And if indeed you think it's just

7 too uncertain, what I would like to know is

8 what part of the process is too uncertain. As

9 Daniel put it, the radiative transfer

10 calculation is really easy.

11 So what part of this whole process

12 is not understood well enough for you to be

13 able to adequately quantify it such that you

14 can put in and say it is this small and

15 compared to the benefits, we can neglect them? 

16 I want to get a feel for the magnitude there.

17 DR. SAMET: But yet, actually in

18 the summary, it says there are potential

19 benefits and it lists awesome things that read

20 a little bit speculatively to me. So, you

21 know, I think your point is it needs to be

22 brought together.

Page 409

1 And if you're claiming small, then

2 you come back and say the potential health

3 benefits, insulin dependent diabetes mellitus

4 for example, I think that's probably a bit of

5 a reach. So I think this needs to be

6 tightened up.

7 Other comments on this? Okay,

8 good, thanks. All right. So now we're really

9 caught up. Which brings us to the sort of the

10 front matter, Joe, so this is with you.

11 So we have, looking at the

12 Preface, Preamble, Executive Summary and

13 Integrative Overview.

14 DR. BRAIN: All right. I'll do my

15 best to maintain the momentum that we've had

16 and deal with macroscopic issues. So as Jon

17 said, there are really four pieces. There's

18 the Preamble, the Preface, and then Chapters

19 1 and 2.

20 And I feel very strongly that,

21 again, this is really a major advance and the

22 document is much better because of these four
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1 pieces which really represent a drastic

2 reorganization of the document.

3 So they're really excellent and

4 definitely in the right direction. So let me

5 now make a few comments about each one.

6 So the Preamble, as you may

7 remember, is the document that really supports

8 not only this ISA, but we liked it, we've

9 talked a little bit about it, because it

10 really supports any pollutant. So it's a

11 general approach.

12 And again, I would really repeat

13 what I said at the beginning. It would be

14 nice to refine it, review it, publish it,

15 distribute it. It should have authors,

16 perhaps KSAC should endorse it.

17 It should not simply, you know,

18 exist as one little tiny piece that people may

19 ignore in these two volumes. But it really

20 deserves wider distribution.

21 And it has, you know, lots of good

22 things in it. It has the framework for causal

Page 411

1 determination. It also occurred to me, are

2 there other things that are generic that

3 should either be here or in another document?

4 In that category is the whole

5 issue of vulnerability and susceptibility, and

6 how do we define those terms, and exposure and

7 dose. So I really like this approach. It

8 would be nice to have, you know, a small

9 number of core documents that the EPA and KSAC

10 and the public could refer to.

11 The only thing that I would object

12 to a little bit, just to pick out one thing,

13 is on page LV, the paragraph begins by saying

14 that, "The most direct evidence of a causal

15 relationship between pollutant exposures and

16 human health effects comes from human exposure

17 studies." And I think it's really unnecessary

18 to award that category first prize.

19 And again, I mean, the paragraph

20 goes on to detail some of the problems, you

21 know, not a range of ages or susceptibilities.

22 And in fact, it seems to me the biggest

Page 412

1 deficiency of experimental clinical exposures

2 is perhaps not emphasized enough, and that's

3 the fact that the outcomes, by definition,

4 must be trivial if it's an ethical study

5 approved by a human IRB.

6 And so I think, you know, the

7 things that really concern us are driven much

8 more by the EPI or by the animal tox studies.

9 This really drives our concern. It's not the

10 relatively modest irreversible things that are

11 seen in clinical studies.

12 So that's just one comment. But

13 otherwise, I think it's really good. And in

14 fact, you know, it's so good that it should be

15 better and should stand on it's own and be

16 available.

17 Just one final thing, sort of the

18 very last section are two pages about

19 ecological effects. And so, you know, if our

20 plant people haven't looked at those two

21 pages, I think that would be useful to get

22 your input.

Page 413

1 You know, does it do a good job in

2 laying out a foundation for all pollutants in

3 relation to ecological effects? So it would

4 be nice to have you give some advice there as

5 well.

6 On to the Preface. The Preface,

7 you know, perhaps needs a better name. It

8 seems to me it's really a historical

9 perspective. And which I found, you know,

10 very useful.

11 It really lays out the history of

12 ozone regulation, and shows how the standard

13 has changed. So I found it very, very useful.

14 One question that I had, I wasn't

15 sure why the last event date mentioned was,

16 you know, March 27, 2008. That's almost four

17 years ago. Why not the latest --

18 MALE PARTICIPANT: Obama

19 statement?

20 DR. BRAIN: -- Obama statement? 

21 You know, why not conclude with the events

22 leading up to the Obama decision? Because I
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1 sort of looked at it as, you know, really a

2 comprehensive, you know, how did we get to

3 where we are now?

4 So I think to add that most recent

5 history would be very useful. It's also a

6 good place, by the way, the references are

7 really all the key references including, I

8 think a complete list of every EPA document

9 relating to ozone.

10 So, again, you know, we've heard

11 some complaints about well, you know, it's in

12 an earlier EPA document. This is the place to

13 look. And that did, for me, raise another

14 question. As I understand it, you know,

15 clicking on those blue references gives us

16 access to all these references, but that's not

17 yet available to the public?

18 And so again, I mean, I look at

19 this as a chapter that would be useful, and

20 would hope that at some point, you know,

21 everybody who wants it could have easy access.

22 Was there a response?

Page 415

1 DR. VANDENBERG: Yes, the HERO

2 system allows access to the public to an

3 abstract and the bibliometric information. It

4 does not provide for published studies, the

5 actual papers, because that would be in

6 conflict with copyright.

7 So the peer review panel has

8 access to everything, just like the EPA staff

9 has. But that's limited to the review of this

10 document, because that's part of doing

11 government business, if you will.

12 DR. BRAIN: So it's really a

13 financial issue. But probably an exception to

14 that would be --

15 DR. VANDENBERG: Well, it's more

16 of a legal one.

17 DR. BRAIN: -- all the EPA

18 documents. So maybe, because again, it would

19 be nice if anybody who wants to could access.

20 I mean, there's a list of, you know, 30

21 documents at the end of the chapter.

22 So maybe there could be some

Page 416

1 exceptions that would be practical and not get

2 you into trouble with greedy publishers.

3 DR. VANDENBERG: Copyright.

4 DR. BRAIN: So, I think that's the

5 Preface. Very, very useful. Then we get to

6 the Executive Summary. And I think, you know,

7 both of us in minor comments, all of us will

8 have some suggestions about it.

9 But in general, I found it, you

10 know, very useful, very effective. It will be

11 valuable for everyone, but also for lay

12 readers, legislators, you know, for everyone.

13 It's 17 pages long. So I think

14 that's a good length. It's, you know, long

15 enough that it can have a little bit of meat

16 in it, and yet it's not so long that people

17 can't and won't read it.

18 One of the problems that I hope we

19 can fix is it has no references, and it has no

20 links. So I could easily imagine, you know,

21 somebody reading the little piece on human

22 exposure, or on populations at increased risk.

Page 417

1 I mean, you know, they're nice little summary

2 paragraphs.

3 But, if you really want more, if

4 something really strikes your fancy, you don't

5 know how to find it. And so, in a sense it's

6 nice, it's uncluttered, easy to read.

7 But it would be nice, and I think

8 probably the solution is the one that you use

9 in Chapter 2, where you then give the citation

10 of other parts of the document. You know,

11 Table 5 in Chapter 5. Or, you know, see 2.4

12 or 3.6.12 or something like that.

13 So I think that was one problem

14 that I found. It seems to me it should be

15 possible to go from the Executive Summary to

16 other parts of the document, if you really

17 want to see more information.

18 One missing part that I find

19 complicated, contentious and important is the 

20 policy relevant background. And I sort of

21 looked through that and there's maybe a brief

22 illusion to it. But I think that to have a
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1 little paragraph about that would be useful.

2 Finally, let's turn to Integrative

3 Overview, Chapter 2. Again, I think it's a

4 step in the right direction. I liked it

5 because it has links. Again, if you really

6 wanted more, it told you just where to go in

7 the rest of the document. So, that's, you

8 know, that worked very well.

9 Again, I sort of looked for stuff

10 about the policy relevant background. I

11 looked for more about children, about

12 susceptibility.

13 Another question is very on, pages

14 2.2-2 and 2-3, there are two pages of

15 questions. Lots and lots of questions. I

16 don't know, there must be 30, 35 questions or

17 something.

18 And it sort of slows down the

19 document. And it sort of raises, you know,

20 are these questions going to be answered?

21 There were, also, I thought, some

22 generic questions that perhaps could be swept

Page 419

1 into the Preface or in another one of, you

2 know, the small number of freestanding

3 documents. I mean, it raises some general

4 issues that would apply to any periodic review

5 of a criteria pollutant.

6 So, I thought maybe that deserved

7 a second look, that long litany of questions,

8 to reduce it. And perhaps put some in another

9 place, because, you know, there really wasn't

10 the promise that all these questions would be

11 answered. Certainly not in any organized way. 

12 So that's my macroscopic view of these four

13 pieces.

14 DR. SAMET: Thanks, Joe. Sverre?

15 DR. VEDAL: So I'm going to take a

16 little bit more of a microscopic view. But I

17 agree with what Joe has said.

18 The only macroscopic point I'll

19 make, and you've heard it before, is that

20 about the integrative summary, which, you

21 know, and this is a constant refrain about

22 emphasizing the integrative aspect of that.

Page 420

1 And, you know, this can make

2 comparison to the PM integrative summary, and

3 this one does not compare to that in terms of

4 the integrative function.

5 I'm not going to say anything any

6 more than what's been said about the Preface

7 and the Preamble. I will say something about

8 the Executive Summary.

9 Again from more of a micro thing

10 because there are some important points, I

11 think, because this is a summary, and it

12 should fairly reflect what's in the ISA.

13 You know, in Table 1.1, you go

14 through the various endpoints and then the

15 causal assignment. One thing that had been a

16 bit puzzling, it comes up in a couple places

17 is CNS effects, where it's always claimed that

18 there's the data are not available for that.

19 Where there's actually a lot of

20 data available and therefore it's given an

21 assignment of inadequate. I think you need to

22 look at that again, because it comes up in the

Page 421

1 Executive Summary and it comes up later.

2 DR. BRAIN: It says suggestive of

3 a causal relationship for CNS, so short and

4 long term, in table 1.1.

5 DR. VEDAL: I have data for that. 

6 There's something that troubled me about the

7 table. Which page is it on? Anyway, I'll

8 come back to that. There's something that

9 troubled me.

10 The other one that had to do with

11 UVB radiation. Now I must be missing

12 something here, because again, there was the

13 issue here is that it looked to me that it was

14 causing no health effects, where I would have

15 thought there's obvious health effects to UVB

16 exposure. This is on table 1.1-3. 

17 DR. BRAIN: Oh, by the way, sorry.

18 It does need work because even though it does

19 say suggestive of a causal relationship, the 

20 -- oh, I see, it's conclusions from the

21 previous review.

22 DR. VEDAL: Oh, yes.
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1 MR. YEOW: Joe, can you use your

2 microphone?

3 DR. BRAIN: Oh, sorry. But it is

4 confusing. How can there be evidence

5 regarding --

6 Mr. YEOW: There we go.

7 DR. BRAIN: -- effects was not

8 available but then how does that fit with

9 suggestive of causal relationship that, see

10 it's totally, something seems wrong. Sorry.

11 DR. VEDAL: Yes, and that's

12 carried over onto other --

13 MALE PARTICIPANT: Sorry, 1-1?

14 DR. BRAIN: Yes, Table 1-1.

15 DR. VANDENBERG: Yes, it's Table

16 1-1.

17 MALE PARTICIPANT: Are there long

18 term effect? I mean long term?

19 DR. SAMET: It's from previous

20 review, I think.

21 DR. VEDAL: What's that?

22 DR. SAMET: The one you're

Page 423

1 pointing to with no evidence is the previous

2 review.

3 DR. VEDAL: Oh, yes.

4 MALE PARTICIPANT: One wonders

5 whether that's correct.

6 DR. VEDAL: All right, some

7 points, I think, that need some clarification.

8 For example, there's a statement that ozone's

9 been consistently associated with total and

10 cardiopulmonary mortality.

11 That's the case for short term

12 exposure. But not the case for long term

13 exposure. So it just needs to be qualified.

14 Then the issue of threshold comes

15 up. And this is admittedly thorny, and it

16 depends a little bit on where you place the

17 acute lung function responses and some other

18 physiological and other responses in the

19 context.

20 It's repeatedly said, and it's

21 important here in the Executive Summary that

22 there's no discernable threshold. That's

Page 424

1 clearly based on the epidemiological data.

2 If you were to take the controlled

3 human study perspective, you might not be so

4 obvious, it might be not so obvious you want

5 to make that conclusion. And so I guess I'm

6 suggesting that it might have to be qualified. 

7 And I made a couple of points regarding that.

8 Also the final point about the

9 Executive Summary has to do with

10 susceptibility, where I think again, it's too

11 strong.

12 You say that there are definitely

13 definite, you know, susceptible or whatever

14 word, descriptor you want to use. When I

15 think you should be qualifying that, that

16 these are potentially susceptible.

17 There's a figure, and it's figure

18 1-1 which is the whole thing about atmospheric

19 chemistry and the stratosphere and then the

20 troposphere and all that. And I find it's

21 really complicated.

22 You know, I was trying to look at

Page 425

1 that figure and try to figure out a couple of

2 simple things, which is, you know, the VOC,

3 you know, potentiation of formation of NO2,

4 sort of a big issue, and ozone quenching.

5 Well, they're kind of there. You

6 can kind of, if you really spend a lot of time

7 looking at it. But, you know, it really takes

8 a lot of digging. And this should be a figure

9 where, you know, those sorts of processes seem

10 to be pretty obvious.

11 So those are the micro things I

12 wanted to say about the Executive Summary. 

13 The micro things about the Integrative

14 Summary. So the questions that Joe brought

15 up, there's that whole list of questions, both

16 for welfare and for health effects.

17 There was one, I'm stepping out of

18 my area of expertise now, but there seemed to

19 be one question missing from the policy

20 relevant questions for welfare effects, which

21 had to do with time course effects.

22 Maybe it's hidden there somewhere.
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1 But because this is so critical to

2 distinguishing the form and the level and the

3 averaging time of the primary versus the

4 secondary standard, it would seem to me that

5 that would be sort of a front and center

6 policy relevant question in the welfare arena. 

7 So, I'll end there.

8 DR. SAMET: Kathy?

9 DR. WEATHERS: So, I'll be quick.

10 I agree with most of the comments that have

11 been made already.

12 On LXV, it seems to me this falls

13 actually on, it's various to saying, is that

14 it seems that the issue that's identified

15 there is that it's difficult to assess the

16 spatial heterogeneity. And that is not the

17 only issue with ecological systems.

18 There's a lot of temporal

19 variability and again, if this were pointed

20 out in this Preamble, it might support the

21 comment that Sverre just made about, you know, 

22 there being no information about temporal

Page 427

1 heterogeneity.

2 Humans, or biology, non-human

3 biology, like human biology is very non4 linear. In the Executive Summary, my issues

5 can be synthesized, I think, by focusing on

6 the figures.

7 Again, this follows on the comment

8 that was just made. Those figures can be

9 quite powerful and integrative, but I find

10 them quite confusing, and they seem to be an

11 afterthought.

12 So, I would encourage you to keep

13 them, but to look at them very carefully and

14 decide what you want to communicate. And I

15 would encourage you to try to communicate

16 large, integrative ideas. So I find that to

17 be kind of frustrating, but an area of

18 opportunity.

19 And in the Integrative section, I

20 would agree with a comment that Helen made

21 earlier. I think that this is an opportunity

22 to beef that up. And others have made it as

Page 428

1 well.

2 And the section on welfare effects

3 represents much of what's in Chapter 9. And

4 to the extent that we liked what was in

5 Chapter 9, it's repeated in this section, as

6 well. And so I would also encourage you to

7 carry over any of the changes that you make in

8 Chapter 9.

9 DR. SAMET: Okay, Chris. You've

10 gotten off easy today.

11 DR. FREY: Yes. Okay, well I

12 agree with everything I've heard. Thank you.

13 No, I'll say a few things.

14 On the Preamble, which I really

15 liked, I don't have a specific suggestion, but

16 I think there could be some flow diagrams or

17 some conceptual diagrams, kind of along what

18 Kathy has been saying.

19 It seemed to me the ISA process

20 itself might have some kind of flow diagram.

21 The various steps by which scientific evidence

22 were considered seemed like it could have one. 

Page 429

1 Maybe, the framework for causal determination

2 could have a flow diagram.

3 I think any time you have the

4 opportunity to come up with a nice diagram, it

5 really helps. So I would encourage that.

6 I already made a comment about

7 needing to say a little bit more about

8 exposure assessment in the Preamble. I think

9 exposure assessment gets pretty short shrift

10 in the Preamble as it stands now.

11 And I think linking exposure to

12 the approach for dealing with risk

13 characterization is important, because I think

14 this Preamble could establish a little bit of

15 a framework for the reader about, you know,

16 why sometimes does EPA choose a fix site area

17 wide monitor as a surrogate for exposure,

18 whereas in other cases an exposure model might

19 be used to represent personal exposures.

20 And, I mean, there are sort of

21 obvious reasons for that to us, but it might

22 not be that obvious to the reader. And that
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1 would certainly help.

2 I think someone already commented

3 that susceptibility and vulnerability and

4 sensitivity, these kinds of terms could be

5 defined in the Preamble. And I don't know if

6 anyone mentioned having a glossary.

7 But I'm not necessarily

8 recommending a glossary per se, because it

9 could actually be a lot of work. But at least

10 any of these key terms should be defined

11 somewhere in the Preamble.

12 Let's see, on the Preface, I

13 enjoyed that. I agree with Joe on the value

14 of the historical perspective. I realize that

15 this document, I guess, has a draft of

16 September 2011, so this might have predated

17 some of the more recent decisions.

18 I don't know, it seems like well,

19 maybe mentioning about the ozone

20 reconsideration and what became of that would

21 at least be a little part of the story that

22 goes in there.

Page 431

1 On the Executive Summary, I felt

2 like there's opportunity to make it shorter.

3 And I think I've strayed into some of the

4 detailed comments. I don't know if I was the

5 motivation for Vanessa's speech earlier today.

6 But on the Executive Summary, it

7 just seems to me that it should convey the

8 basic purpose, the whatever relevant context

9 there is, the methods, results and key

10 findings. And it's not the same as

11 summarizing or borrowing text from other parts

12 of the document.

13 So it's sort of like in a big

14 abstract is how I might think of it. So in my

15 comments, I won't go into details, but I

16 illustrated, I think, a lot of wordsmithing.

17 But I think in the context of the Executive

18 Summary, it's really critical that it be as

19 short as possible.

20 So I thought rather than just say

21 make it shorter, I would give some examples,

22 so I have that in my written comments. And,

Page 432

1 you know, I'm sure it's hard to get it down to

2 ten pages, but I would say that might be a

3 good goal. And if you get it to 14 or 12,

4 that's great.

5 But I guess, keep in mind who's

6 the audience for that, right? And it will be

7 more accessible if it's short and if it's not

8 full of too much jargon.

9 I actually agreed with a comment

10 about the figure about the ozone chemistry. 

11 I mean, I like that figure, but I think it's

12 probably beyond the audience you're trying to

13 reach.

14 So if it's important to have a

15 figure like that, it probably needs to be a

16 different figure, or that figure might be

17 deleted.

18 On the Integrative Summary, you

19 know, generally I liked it. I agree with the

20 comments about making it more integrative and

21 maybe less of a summary.

22 And again, I would just throw out

Page 433

1 a challenge that if you can figure out ways to

2 put in conceptual diagrams that tie things

3 together, that would be beneficial to the

4 reader.

5 And maybe a challenge for Chapter

6 2 is to distill a little more clearly what did

7 we learn from this ISA? What do we know now

8 that we didn't know before this document was

9 developed? And that might help focus some

10 conclusions or findings. And that's it.

11 DR. SAMET: Okay, thanks, Chris. 

12 One comment on the Preamble, and you're

13 familiar with it.

14 My look at it as a potential model

15 is the Preamble to the IARC monographs. 

16 Which, of course, actually a lot of work goes

17 into that Preamble and it is peer reviewed and

18 published. And I think IARC is probably

19 updated, maybe over ten years on, perhaps

20 somebody knows.

21 But it is, I think, a useful

22 model. And it's the same in every monograph.
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1 So you can look at it. You had a figure in

2 the PMISA on the whole process, or there's

3 several figures. Those seem to have been lost

4 here.

5 And I think they would go back to,

6 maybe it was Chris who called for such a

7 figure. But you had to actually develop some

8 very useful figures describing how this set of

9 documents figures into decision making. So it

10 would be useful to think about doing those.

11 Just a couple of other comments. 

12 The Executive Summary, so that's really

13 intended, if I understand where you've gone

14 with it, to be a general public summary.

15 And maybe it should be labeled as

16 such, and not called an Executive Summary. I

17 mean, so there's no that there's no ambiguity

18 about who it is, it's for everybody.

19 And so maybe the name should

20 change, which would leave you with the

21 question of whether you do need an Executive

22 Summary. Right now your so-called integrative

Page 435

1 health effects is falling a little more into

2 the realm of that kind of document than not.

3 So I think, you know, again, and I

4 think there's a role for having the

5 integration. So I think you have to decide,

6 but I think to have the general public summary

7 is important and useful.

8 And then after that, to have a

9 true Integrative Summary, I think would be the

10 ideal, and perhaps you should shoot for. But

11 again, it might be useful to hear from others

12 about what you think ought to be here.

13 And one last comment on the

14 threshold issue, because I think it's

15 important. And maybe this is an issue that,

16 in part, belongs in the Preamble.

17 I mean, actually the kinds of data

18 needed to determine if a threshold is or is

19 not present, I mean, generally are

20 mechanistic. And if one were to rely on

21 animal studies, or human studies, whether

22 experimental or observational, you need a lot

Page 436

1 of data.

2 And you need some data that will

3 provide you with something relatively robust.

4 It becomes a matter of model fitting and

5 slight preference as measured by AIC or R6 squared or whatever it is, from one model over

7 another.

8 That's not getting you too far. 

9 So maybe that's perhaps a preamble issue as

10 well, because that's going to be so important

11 in evidence interpretation.

12 So let me ask others for thoughts

13 on this. And particularly the Executive

14 Summary, Integrative Summary. Judy?

15 DR. GRAHAM: I think if the

16 Executive Summary is intended to be an

17 executive summary, I agree with Chris, that it

18 doesn't really go after what a policy maker

19 would need.

20 If it's intended, however, to be a

21 shrink wrap of the document for the general

22 public, then I think its structure is okay.

Page 437

1 But I think that the text that's here needs

2 careful revision.

3 And I won't go into detail except

4 to say, like on the exposure, exposure's not

5 defined. The word high-end exposure's not

6 even mentioned.

7 There's two paragraphs on

8 exposure. One paragraph says how do you

9 measure exposure? Who cares? What is the

10 exposure? You know, what contributes to the

11 high-end?

12 So on the Integrative Summary, I

13 would say to use consistent definitions

14 throughout. But I guess, in some cases, it

15 was too brief. Like, key determinants like

16 exercise weren't mentioned. Makes a humongous

17 difference to human clinical studies.

18 You couldn't read this and know,

19 oh this study was with exercise. I'm not even

20 talking about moderate versus heavy, although

21 I would like that. Just, did they have

22 exercise?
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Page 438

1 There's tables there. There's no

2 indication that some of these effects were

3 irreversible. Some of the animal studies

4 showed irreversible lung structural changes.

5 That's a big deal, that it's irreversible.

6 What about the impact of

7 inflammation? So I think that some of the

8 changes you make in subsequent chapters are

9 going to help these.

10 DR. SAMET: Sure. Ted?

11 DR. RUSSELL: I'm not sure if this

12 is more a comment of the Executive summary in

13 Chapter 2, or of Chapters 9 and 10, but if you

14 look at the Executive Summary and such, in

15 terms of the non-human effects, you have the

16 very specific comments in bold, a causal

17 relationship between X and Y exists or likely

18 causal.

19 You don't actually see that in the

20 chapters themselves. It's not so succinctly

21 put. I mean it works out much better, I

22 think, if you do have those specific

Page 439

1 statements in the chapters.

2 And in part, I think this would,

3 you know, I was reading through Chapter 10,

4 and you make the statement, "Reduction of

5 tropospheric ozone concentrations could

6 therefore provide an important means to slow

7 climate change."

8 But in the Chapter 2, in the

9 Executive Summary, you have, "It is likely to

10 be causal relationship." And where did the

11 two come together, is that if it's important

12 I think it would be a causal relationship.

13 So I think in some ways, those two

14 have to come together. And so, I think

15 everything in terms of the welfare benefits,

16 that's missed.

17 DR. SAMET: Fred?

18 DR. MILLER: I would like to go to

19 2-22, the Figure 2-3. It was shown this

20 morning. And I feel like this figure is

21 misleading, because the arrow that talks about

22 severity and goes from yellow to red has the

Page 440

1 entire bottom of the pyramid as yellow.

2 And to me, when you get to the

3 left hand side and you're talking about

4 altered developmentive respiratory tract and

5 altered morphology, that should have some

6 shade of red. So I personally feel that this

7 particular figure is misleading.

8 I thought there were earlier

9 discussions about questioning the extent to

10 which there really is evidence for this new

11 onset asthma.

12 And so, again, as you do and

13 incorporate the comments and revisions, this

14 figure might change in terms of some of the

15 things. But I clearly don't see where the

16 bottom row is all yellow.

17 DR. BRAIN: Nor do they all lead

18 to asthma exacerbations. You would sort of

19 look like these are all components of the next

20 layer, which is asthma exacerbations. And

21 four on the left seem to not connect.

22 DR. MILLER: So maybe some

Page 441

1 reworking is needed there. But I like the

2 idea of it. Don't get me wrong.

3 DR. SAMET: Okay, other comments? 

4 DR. SUH: I actually didn't like

5 that figure at all. I didn't even really like

6 the idea so much. You know, I guess I think

7 a figure should be just you look at it, it's

8 clear. You know, you get a picture of what it

9 is.

10 I mean, I like the idea of

11 something like this. But I think this, itself

12 is, I'm trying to be too much. And I think a

13 figure would be great.

14 But, you know, I don't know what

15 that figure is. Sorry, I'm sorry. That's

16 very not helpful. Not helpful, not

17 constructive. But I guess I would just scrap

18 the figure and try again, as unconstructive as

19 that comment is.

20 But I guess I find it so busy that

21 you don't even know what's important in that

22 figure. So I think if the figure doesn't
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Page 442

1 convey what's important, you know, from the

2 get-go then you just need to start over.

3 DR. BRAIN: And then maybe you can

4 tell us, I'm confused as Sverre was for the,

5 you know, table that he pointed out in Chapter

6 1. And then in Chapter 2, if you look at page

7 237, you know, Table 2-2.

8 The first column is clear,

9 vegetation, ecosystem effects. And then the

10 middle one is conclusions from the previous

11 document, and then conclusions from the

12 current one.

13 So I mean, it doesn't really make

14 sense to me because, I mean, you would think

15 you would sort of look at the data, the

16 evidence in the middle and that would lead to

17 something on the right.

18 But, you know, it doesn't tell you

19 what the rating was in 2006, nor does it tell

20 you the basis for the 2011. So I just find

21 that -- am I missing something?

22 DR. SAMET: You might be. I

Page 443

1 think, Joe, these are the conclusions. I

2 mean, there was not a similar scale of

3 language.

4 DR. VANDENBERG: We didn't have

5 the same framework at that time. So that's

6 why the language doesn't line up very well.

7 DR. BRAIN: But I guess, then the

8 question is, would you have the same

9 conclusions for causal relationships based on

10 the 2006 data?

11 DR. VANDENBERG: We're just trying

12 to reflect what was in that document at that

13 time.

14 DR. BRAIN: Well, then, I mean, so

15 are they the conclusions based on the 2006

16 data?

17 DR. VANDENBERG: Yes.

18 DR. BRAIN: Oh, but then you would

19 like to know, did any of them change with the

20 additional data in this document?

21 DR. VANDENBERG: Right. Yes.

22 DR. BRAIN: I'm finding myself

Page 444

1 very confused by it.

2 FEMALE PARTICIPANT: It's the same

3 thing for the human.

4 DR. BRAIN: Right, yes, it's the

5 same thing for the human, I think, which then

6 was the, you know, the concern that Sverre

7 had.

8 How could it on the one hand say

9 that, you know, evidence regarding chronic and

10 neural behavioral effects was not available.

11 And then you look over to the right and it

12 says suggestive of a causal relationship. I

13 mean, that just doesn't make sense.

14 DR. SAMET: Well, I actually think

15 the table is useful. Maybe it needs to be

16 better explained or formatted or something,

17 because I think they're really just trying to

18 show how bottom lines have changed, or not

19 changed, and that there was a descriptor that

20 was not standardized in the earlier reviews,

21 and now there is one.

22 And in some cases, you might be

Page 445

1 able to say that they align or don't align. 

2 In some cases you have apples in one column

3 and oranges in the other, which probably leads

4 to some of the confusion.

5 But I think the tables are useful

6 to show how bottom lines have changed.

7 DR. BRAIN: But as a summary, I

8 would like to know conclusions from this

9 review. You know, what are the conclusions,

10 a narrative statement. And then how does that

11 translate into, you know, one of these

12 ratings?

13 DR. SAMET: Yes, do you have any

14 other comment on this, John?

15 DR. BRAIN: No.

16 DR. SAMET: Okay, so other

17 comments on this front matter. Yes, Daniel?

18 DR. JACOB: Well, there were some

19 comments made about the Figure 2.1 being too

20 complicated. I think I can provide something

21 better. I'll submit it.

22 DR. SAMET: I'm sure that would be
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Page 446

1 welcomed. Okay, anything else? I'm sensing

2 a certain lull here, and I think we've done

3 our job. So let me make some comments, just

4 the reminders about things, and some things I

5 want you to think about tonight.

6 So, remember the lead person has

7 the job of essentially drafting what will go

8 into our letter to the administrator in

9 response to the charge question.

10 So you have written comments, I

11 think, in most instances from all of your

12 colleagues. We've had discussion here, I

13 think there's been some new things that have

14 come up in the discussion that should be

15 reflected in your written comments. And

16 tomorrow we'll go through those.

17 I think, also, we want to

18 highlight, think about what is the most

19 important findings that should be brought

20 forward into the letter, the body of the

21 letter itself to the administrator. And that

22 will really form the framework for our

Page 447

1 discussion tomorrow.

2 I think a couple of other things

3 that have come up. I mean there's been some

4 mention about whether the extent of the

5 changes we are requesting is sufficient enough

6 that it might be appropriate for us to see an

7 additional draft, meet and discuss that draft.

8 I think we'll leave any judgment

9 on that until tomorrow when we go through the

10 comments and look at what changes we are

11 requesting. But that would be something for

12 everyone to think about tonight. It might

13 slow, John, the optimistic schedule a bit.

14 DR. VANDENBERG: Cautiously

15 optimistic.

16 DR. SAMET: Your cautiously

17 optimistic schedule. So, I mean, I think this

18 is something that we should just not decide

19 now, but look at tomorrow after we've gone

20 back through, circled back through the

21 comments.

22 I was reminded, Vanessa, was there

Page 448

1 was some discussion about the handling of the

2 individual comments? And can we go back and

3 just revisit that for a moment?

4 DR. VU: So as you recall, the

5 report to the administrator has a short letter

6 that highlights the key recommendations and

7 findings from this body. And then you have,

8 appendant to the letter you have a consensus

9 or the group response to the individual charge

10 question. It has more detail in it.

11 And I think you don't plan to

12 discuss it tomorrow, but the lead also have to

13 provide that written response so that Aaron

14 will be collate all the responses together in

15 addition to the letter to the administrator.

16 And as always, the individual comments will be

17 appended to the report.

18 So I just want to make sure there

19 are three pieces to the report. So is that

20 clear, Jon?

21 DR. SAMET: Yes.

22 DR. MILLER: I have a question for

Page 449

1 the DFO. Has anyone from the public requested

2 time tomorrow?

3 MR. YEOW: Yes, we have one

4 request for tomorrow morning, so far.

5 MALE PARTICIPANT: I would like

6 some time.

7 DR. SAMET: Okay, if anyone who

8 does would see Aaron afterwards. Let's see,

9 Michelle?

10 DR. BELL: I just want to ask

11 Vanessa, I'm not clear on the three different

12 things that we are providing. So we have our

13 individual comments, we've already said.

14 We'll have the, you know, short

15 parts that will go into the letter. And then

16 I wasn't understanding the other one, because

17 it's going to be hard to aggregate the

18 individual comments. It's just going to look

19 like an appendix.

20 DR. VU: And Michelle, we're not

21 looking for you to do that by tomorrow. 

22 That's after the meeting.
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1 DR. BELL: Can you tell me more

2 about what that is? I mean, I'm just, it's

3 all on different topics. I feel like it will

4 just be cutting and pasting.

5 DR. VU: Yes, Aaron's going to

6 give you, or I'll send you an email, what the 

7 panel's comments on the last first draft ISA.

8 So that will be helpful.

9 But with regards to the individual

10 comments, you're welcome to revise your

11 preliminary comments which is part of the

12 final letter to the administrator.

13 DR. SAMET: But actually,

14 Michelle, I mean, yes, it's fairly

15 straightforward what you need to do, which is

16 to provide the answer to, in your case, the

17 charge question related to Chapters 6 and 7.

18 That can be based on your own

19 response, adding in the additional comments

20 and coverage from those others. I think, in

21 your case, you have four other people to look

22 at their responses. Bring it into one total

Page 451

1 integrated response.

2 And, you know, to the extent that

3 there were new things that came up in the

4 discussion that are not reflected in those,

5 then add those in.

6 And again, these should not be

7 particularly lengthy. I mean, I think I would

8 just make that comment. They really should be

9 to the point.

10 MALE PARTICIPANT: The ones for

11 tomorrow.

12 DR. SAMET: Well, the ones for

13 tomorrow.

14 DR. MILLER: Right, and then,

15 Michelle, maybe of the ones that you do for

16 the response to the charge, maybe there's two

17 of them that should be highlighted in the

18 letter.

19 DR. SAMET: Exactly.

20 DR. BELL: I understand the

21 letter. I wasn't sure about the other one. If

22 I could get more guidance, I can wait. DR.

Page 452

1 SAMET: Right, and we'll send you the last

2 letters for you to look at. So that you have

3 a little guidance on --

4 DR. BELL: I understand the

5 letter.

6 DR. SAMET: What we call the

7 letter is three parts. The letter to the

8 administrator, the consensus response to the

9 charge questions and then your individual

10 comments.

11 So when I send that out to you,

12 you'll see the consensus response to the

13 charge questions, you'll know, you know, how

14 long they should be, how detailed they should

15 be.

16 But it doesn't need to be, you

17 know, it's something that you should develop

18 as the consensus for your sub-group. So you

19 don't have to copy and paste all the

20 individual comments into there.

21 It's, you know, based on what

22 you've read, what you've heard during the

Page 453

1 discussions today as the consensus for your

2 sub-group.

3 DR. SAMET: And just as a

4 reminder, we have tried to keep the letter to

5 the administrator itself relatively brief. 

6 And then build off the response to the

7 comments.

8 And this is where we really want

9 to get to, truly the most important things

10 that, in this case we think are on target and

11 let's say what remains to be revised. Daniel?

12 DR. JACOB: So what do you want by

13 tomorrow?

14 DR. SAMET: Oh, everything. No,

15 actually by tomorrow, I mean, I think probably

16 you could have certainly, the minimum is the

17 bullets that would say, here's the main points

18 in answer to the charge questions that you

19 have. For example, the first one that you

20 took on, the Chapter 3.

21 So the bullets that would be your

22 most important points. I don't think this is
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1 not such a big task that you might not have

2 the whole thing actually done.

3 Remember, this probably should be,

4 I don't know, three paragraphs, four

5 paragraphs, but not long. You know, it should

6 really be focused and to the point, and

7 something that will be useful guidance to the

8 agency.

9 DR. JACOB: Forgive me. Okay, so

10 then we have the individual comments, which

11 can be very long and also bring up a lot of

12 important points. You know, so will these be,

13 then, provided for consideration?

14 DR. SAMET: They're there. Oh

15 yes, that was what Vanessa was saying. Those

16 are part of what is turned in.

17 DR. JACOB: But these, then don't

18 have to be integrated for individual chapters.

19 They can just be the individual comments?

20 DR. SAMET: Your individual

21 comments go in with your name right beside

22 them.

Page 455

1 DR. JACOB: Okay.

2 DR. VU: I think it will be

3 helpful after you look at what Aaron sent you.

4 It could just refresh your memory. But I

5 think what Jon is looking for tomorrow is what

6 are the key point you want to highlight.

7 You heard a lot of discussion

8 today, but you want to crystallize, synthesize

9 the key point. And you will have opportunity

10 to provide a written response for the

11 individual charge questions.

12 Aaron then pull the report

13 together. Aaron will schedule another public

14 teleconference call for you all to go through

15 the draft letter, the draft response, and

16 appendant your individual comments.

17 So you will have more opportunity

18 for you to look at to make sure you are

19 comfortable with the letter to the

20 administrator and the attachments.

21 DR. SAMET: Yes, Joe?

22 DR. BRAIN: I would just echo what

Page 456

1 you said at the beginning of our meeting, that

2 we need not be confined to the charge

3 questions. And so if we've, you know,

4 uncovered some other big issues, I think and

5 historically, Jon correct me, but once in a

6 while, they find their way to the letter to

7 the administrator.

8 For example, I can imagine us

9 saying we really like the idea of freestanding

10 core documents that would apply to all, you

11 know, future reviews of criteria documents. 

12 So that would be an example of something that

13 we might want to put in the one or two page

14 letter to the administrator.

15 And then there are other things,

16 again, that you may put in your own personal

17 comments. So again, I think that's another,

18 am I right? That's another thing that you

19 would encourage --

20 DR. SAMET: Yes.

21 DR. BRAIN: -- is things that are

22 not in the charge questions, but you think

Page 457

1 they are important.

2 DR. SAMET: More overarching. And

3 actually, I'm just going back from my notes

4 from this morning when we had the discussion

5 of the charge, the adaptation. There are a

6 couple of issues that came up.

7 The adaptation, attenuation issue

8 which may be one that goes back to, say that

9 needs more consideration. And then this point

10 that has come up again. I think, Fred, Judy

11 I think probably particularly championed this

12 idea of the physiological indicator of FEB1

13 versus other processes that are initiated by

14 exposure and sorting this out.

15 So those were both sort of things

16 we talked about this morning as important and

17 still are. Okay, so the other would be after

18 you sort of at least get your bullets

19 together, if you could email those to Aaron.

20 He's asked that you email them by

21 roughly nine, because what he'll do is he will

22 compile them and send them back out to us. So
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1 you can take a look before morning.

2 Let's see, and we reconvene at

3 8:30 tomorrow. We end at 11:30, I think many

4 of us probably have flight schedules based

5 around an 11:30 finishing time. So let's aim

6 for it.

7 Probably some of you have flight

8 schedules aimed around a 10:00 finishing time.

9 But wishful thinking. But I think we will

10 need the three hours to get through our job.

11 So let's see, if there's nothing else, let me

12 turn it over to Aaron for last words here.

13 MR. YEOW: Right. So again, just

14 a reminder to the public, if you want to make

15 a clarifying remark for tomorrow's session,

16 please come see me and let me know. And limit

17 that to one minute and it's just for

18 clarifying remarks for the panel to consider.

19 I think that's all we have. Did

20 you have a question, Fred?

21 DR. MILLER: Can we leave our

22 written material here, so we have it on a

Page 459

1 computer disk? Or is this going to be locked,

2 or do we need to take everything with us?

3 DR. VU: You can leave everything

4 here except your laptop.

5 MR. YEOW: Yes, you can leave your

6 written materials here. I wouldn't leave

7 anything valuable, though.

8 DR. SAMET: Okay, well.

9 MR. YEOW: You know what I meant.

10 I guess I have to do something. Yes, you got

11 off easy.

12 (Whereupon, the foregoing matter

13 was concluded at 5:10 p.m.)

14

15

16

17

18

19

20

21

22
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abrupt 236:7

abscisic 401:4

absence 52:14

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absent 71:6

absolute 202:7

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absolutely 316:8

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absorbed 271:12

absorption 279:7,8

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abstract 415:3

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AC 54:14

Academy 105:8

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accept 205:15

228:6

acceptance 95:21

203:7,9 210:2

accepted 134:5

accepting 203:8

access 153:21

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accessible 229:16

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accompany 142:4

accomplished

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account 144:20

149:6 150:17

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236:9

accountability

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accountant 389:11

accounting 389:12

accredited 154:21

accumulated

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accumulates 129:9

accumulative

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accurate 130:22

accurately 106:16

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achievable 69:13

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achieve 70:14

169:8

achieved 69:4 90:8

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acid 295:8 401:5

acinar 281:15

acknowledge

371:11

acknowledging

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acknowledgment

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ACS 98:11

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181:18 182:5,7

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action 5:5 7:20

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97:9 121:2 171:12

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activities 55:10

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activity 32:12

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actual 90:10

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acute 228:4 288:9

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ad 386:7

Adams 108:12

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adaptation 211:15

318:8 457:5,7

add 46:22 209:2,22

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added 22:13,15

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addendum 63:15

adding 276:17

285:11 450:19

addition 15:16

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188:7 199:18

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additional 15:22

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61:15 62:11 90:18

121:17 133:10

136:9 206:5 274:7

359:9 363:9

443:20 447:7

450:19

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143:7

address 62:15

64:14 68:18 70:10

95:16 101:2,14

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addressed 244:9

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318:6,7 337:12

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adds 96:22

adequacy 81:11

82:21 83:1 111:8

114:2

adequate 161:20

adequately 98:15

112:10 113:19

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204:17 408:13

adjacent 131:1

adjourn 16:5

Adjournment 5:22

adjust 82:9 84:18

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adjusted 150:22

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adjusting 223:14

adjustments

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administration

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administrator 6:20

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446:8,21 448:5,15

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administrators

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admissions 119:13

admittedly 213:15

423:15

adopted 39:1 66:20

adult 277:5 286:3

adults 27:22

118:15 124:18

advance 7:1 409:21

advancement

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advancements

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adverse 72:12,16

73:3 105:12

107:20,22 108:11

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113:2,10 118:20

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173:3,5,8 218:20

290:8 323:9

346:12,12 347:1

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366:7,19 367:13

368:11 372:22

374:2 377:6

adversity 72:2,9,20

72:22 73:7,9,15

advertized 404:13

advice 6:19 9:9

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359:20 360:14,22

413:4

advise 344:12,16

344:18,21,21

345:2

advisories 28:5

advisory 1:3 6:6,13

6:16 8:7,18,20 9:7

10:15 344:17

advocating 339:21
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affect 27:17 32:10

132:14 175:4

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affection 209:22

afternoon 214:3

afterthought

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after-meeting

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age 46:19,20 123:4

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agency 1:1 2:10 7:5

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agency's 9:2 10:2

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agenda 3:6 11:16

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ages 124:18 128:8

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ago 61:5 157:6,9

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agree 39:20 100:12

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agreed 183:12

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agreement 126:17

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agreements 181:22

agricultural 220:1

agriculture 402:10

ahead 16:17 33:21

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249:17,21

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aim 88:18 458:5

aimed 458:8

air 1:3 3:17 4:16

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46:1,16 49:17

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173:12 180:1,4,5

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364:11 374:9

402:9 404:10

aircraft 188:8

AIRMAP 237:12

airway 75:10,19

277:3 283:4,6

300:6

airways 322:11

329:6

al 96:21 118:18

147:14,20 152:3

154:10 159:1,2

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193:22 194:10,13

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195:16 196:4

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280:13,19 283:2,3

365:22 398:2,2,2

398:7

Alaska 189:14

alerts 27:15

algorithms 136:2

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align 445:1,1

Allen 1:16 4:21

14:2,2 193:6

200:22 227:8

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alleviated 60:15

Alliance 89:15

allocate 295:19

allocation 392:15

allotted 88:4,15

allow 48:10 207:4

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allowing 354:3

allows 95:7 99:18

124:16 129:9

332:11 415:2

allude 283:10

368:16

alluded 79:11

81:18 115:18

270:1

alluding 244:17

allusion 325:11

349:6

alter 270:15

alteration 33:8,11

75:14

altered 75:9,10

361:22 394:20

440:4,5

alternate 174:1,9

alternative 51:17

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58:1 65:16,20

82:13,18 83:1

84:21 97:20

167:16 168:4

205:2,4

alternatively

274:22

alternatives 83:8

83:20 84:1 97:7

altitudes 189:7

ambient 5:2,4

18:22 27:16 28:19

47:2,9 48:14 49:3

49:4 55:20 56:18

85:5 94:14 97:16

97:22 106:1,14,16

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113:11,20 120:3

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180:4,5 201:10

204:22 215:7

238:8 249:2

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364:7,10 398:18

399:14

ambiguity 434:17

ambiguous 108:1

Ambrose 195:6

Amdur 292:4

America 134:3

141:10 181:13

183:20 190:21

195:11

American 4:2 26:7

62:9 106:7,13

118:5 140:15

147:9 174:8 181:1

181:5 186:16

189:3,16 198:7

217:13 228:12

329:19 331:7

Americans 131:9

amount 89:22

101:20 106:8

127:4 279:10

284:19 360:17

amounts 189:4,15

Ana 1:18 9:16,19

13:9 362:12

372:20 376:8

analogous 102:19

analogue 95:1

analogy 236:15

246:5 328:17

analyses 57:15

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118:13 141:20

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172:6 174:7

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analysis 3:23 35:20

45:9 47:15,16,18

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57:7 60:4,9 86:17

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analyzing 155:6
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and/or 7:17 247:15

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animal 97:8 276:17

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339:10 347:9

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Anne 90:3

announce 88:10

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announced 116:3

annual 141:10

185:9 227:18

answer 41:9,17

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93:11 137:19

145:21 161:5,6,10

270:16 323:10

450:16 453:18

answered 318:5

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anthropogenic

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anticipated 16:7

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antioxidants

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anybody 138:14

341:21 384:17

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anymore 220:11

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anyone's 356:9

anyway 155:19

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apologize 198:19

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appreciated 17:4

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approximately

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arbitrary 351:22

area 28:14 93:17

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arguably 96:7

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argumentation

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aside 112:9 300:14

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asleep 256:2

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asserts 171:20

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assessment 3:9,12

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cleaning 287:18

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clear 35:2 38:13

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272:6 273:21

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112:11 115:6,10

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116:19 117:18

118:3 123:7

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154:15 157:2

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231:3,15 234:20

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256:8 258:4 259:2

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293:13 296:22

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306:7,12 311:14

317:6,17 319:13

319:21,22 341:14

342:20 343:7,20

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compelling 108:20

compensating

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113:7 120:6 210:8

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287:22 302:19

374:5 388:3 412:7

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concerned 131:8

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concerning 180:1

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150:19 238:1

242:22 346:13

concise 27:4 33:17

321:2

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concluded 184:8

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conditioning

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conduct 6:10

conductants

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conducted 6:22 7:5

105:11 107:16

123:22 124:7

126:9 337:17

375:7

conducting 283:4,6

confession 341:7

confidence 96:1

104:22 113:14

149:15,21 171:15

confident 251:8

326:4

confined 456:2

confirm 190:18

confirmed 195:8

conflict 8:6 415:6

confounded 348:3

confounding 95:22

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99:13 104:21

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264:13

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confused 442:4

444:1

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313:18 315:12

316:13 324:2

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confusion 34:22

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congratulations

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conjunction 124:1

connect 275:19

370:18 440:21

connected 268:2

273:1 290:16

connects 271:13

conscious 312:17

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conserving 224:22

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constrictive 322:1

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constructive

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consultant 12:4,19

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contained 150:3

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contemplated

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contradictory

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contributed 196:8

contributes 193:16

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contributing 64:2

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191:2 195:11

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contributions

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control 90:9,10

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162:10 164:13

201:7,15 202:3

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369:7 399:16

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236:13 398:12,15

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criticized 271:16

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cross-cut 209:12

cross-linking 277:1

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CSAPR 237:7

CSTRs 395:12

CTMs 240:10

cultural 375:16

cumulative 94:11

204:1,7 205:5

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curious 205:10

current 28:19

51:16,22 52:21

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124:2 170:3,20

173:3 182:17

196:18,19 201:14

204:16 205:7

218:1 236:13

266:1 295:20

355:4 442:12

currently 45:17,20

47:10 53:14 56:21

69:1 71:6 185:6

186:5 225:8

curve 130:3 133:11

133:19 148:17

151:11 163:13

170:22 171:7

curves 171:13

199:6

cusp 79:8

cut 304:20 311:2

333:13

cutting 73:19

210:21 450:4

cycle 164:15 352:4

cycles 349:8

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

3:1 4:1 5:1

CþV 137:3

D

D 2:2

dab 287:12

daily 91:3,4 92:8

108:6 183:6 185:8

316:20

damage 274:21

278:17 295:15

Dan 34:1 191:10

Daniel 2:5 12:22

74:4 164:22 178:2

198:18 215:8

222:11 223:4

227:9 239:16

245:7 249:9

407:17 408:3,9

445:17 453:11

Daniel's 221:6

231:8

data 28:12,13

31:13 46:8 47:3,9

48:15 49:4,4,12

49:19 51:19 54:10

54:11,12,14 55:20

55:20 56:18 57:12

57:19 58:8 61:16

61:18,21,22 62:11

62:12 77:12 84:22

85:5,6,20 98:12

98:15 106:1,16

107:1,15 118:13

121:8 124:5 125:2

125:7 126:5,9,21

127:8,12,13,18,19

128:21 129:6,17

130:20 131:13

132:21 133:3,10

133:22 136:9,12

145:7 148:7,11,12

148:20 151:14,18

152:6,13,15

153:18 155:4,6,18

155:19 156:4

157:10,10 166:20

169:22 170:17

171:2,12,21

174:20,20 176:20

183:22 184:18,21

189:1,2,18,20

196:4 199:5 203:7

203:12 206:21

228:16 237:2,10

238:8,9 242:12,12

246:7 253:12

260:2,3,8,10,19

260:21 263:2,18

263:19 268:6,16

278:14 284:3,20

322:16 326:19

334:19 342:18

343:18 349:19,22

350:2,5,7 352:17

388:11 392:5

420:18,20 421:5

424:1 435:17

436:1,2 442:15

443:10,16,20

dataset 62:9 126:10

136:6,8 149:4

150:3 152:9 155:3

datasets 62:8

date 107:17 309:21

349:5 351:20

359:16 413:15

Dave 70:20 84:9

David 2:2,4 12:18

13:18 71:13

159:21 221:2

239:13 265:22

387:16 389:5

390:9,10 395:9

Davis 127:9 277:8

day 14:18 16:17

26:14 33:21

110:10 237:8

269:16,20 277:17

288:11 312:13

314:2,9 330:20

337:21 348:17

373:14 377:5

380:11 384:1

days 61:9 288:11

314:1 382:11

402:8

daytime 187:15

188:3

deadlines 182:7

deal 15:9 61:10

256:11 400:4

409:16 438:5

dealing 21:13

429:12

deals 314:1

dealt 385:1

death 119:13

debated 199:5

Deborah 4:2 118:4

118:5 122:22

debris 196:5

decade 236:2 406:2

decades 62:13

110:21

decay 178:19

December 44:12

decide 70:11 125:4

253:7 365:20

380:4 427:14

435:5 447:18

decided 300:15

decides 332:1

deciding 180:9,14

decision 63:13

102:9 117:14

135:15 229:4

242:8 301:1 302:6

310:18 311:9

312:17 413:22

434:9

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76:17 107:8 114:5

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Department

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deposition 225:3,6

depth 30:15 300:2

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derived 24:20

descending 194:14

describe 87:15

113:18 114:7

297:2 357:2

described 34:14

113:3,22 125:8

296:9 325:19

describes 19:20

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describing 157:10

159:3 299:14

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description 34:3

315:7 321:22

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deserved 419:6

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design 47:4 227:15

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95:5

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designation 95:6

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designed 118:19

despite 108:19

239:2

detail 46:14 121:17

169:11 231:8

289:10 292:2

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411:20 437:3

448:10

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233:6 272:3 431:4

452:14

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determinants

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determinations

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252:19

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Detroit 53:21

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de-emphasis

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116:8 449:1

diabetes 409:3

diagram 428:20

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dies 353:20

diesel 235:22

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difference 130:10

135:3 155:21

156:22 189:4

205:14 206:17

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282:12 437:17

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156:8 161:3 202:8

202:19 206:10,18

206:20 281:3,22

283:12 375:16,17

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20:4 24:10 26:2

34:6 36:10,11,13

37:5,17,19 39:1

43:7,8 50:8 51:12

62:4,12 70:3,7,12

70:15 83:7 130:7

130:8 152:6 156:7

161:3,11 174:9,12

206:2 219:7

220:12 221:11

226:2 227:14

234:6 256:4 257:9

268:21 271:10

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discussions 7:3,20

15:17 66:16,19

69:2,17 102:13

208:11 269:11

354:14 440:9

453:1

disease 151:9

213:17 342:4

diseases 337:14

disk 459:1

disparate 319:11

dispel 284:10

dispersion 191:19

disproportionately

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disrespect 210:2

Disruptor 169:18

distal 367:22 368:1

distance 263:5

distances 262:17

distill 433:6

distinct 87:10

distinction 206:16

346:18 347:14,14

347:16 352:10

354:20 355:11

357:6

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320:18 332:12

364:2 399:14

distinguishing

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distribute 410:15

distributed 35:9

234:5

distribution 56:9

71:18,20 93:19

125:18 141:17

148:13,22 149:14

174:16 175:17

176:16,17 191:17

217:6 223:15

240:17 410:20

distributions 113:5

194:16 223:8

disturb 74:9

diurnal 91:1 108:7

176:9

diversity 399:6

divided 80:19

154:4 381:11

383:13

divisible 304:13

division 17:11

308:20 313:13

doable 136:13

Docket 199:16

201:1

doctors 162:11

document 10:2

17:12,14 21:5,7

22:7,12 23:5 25:3

30:21 34:19 35:8

38:12 39:4,9,12

41:14 71:5,10

73:22 105:9

109:14 119:22

120:4 121:6

169:17 179:11

194:10 208:17,20

209:15 213:8

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316:6 317:11

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354:21 356:6

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366:15 367:3

376:19 379:2

391:14,20 397:16

400:21 409:22

410:2,7 411:3

414:8,12 415:10

417:10,16 418:7

418:19 430:15

431:12 433:8

435:2 436:21

442:11 443:12,20

documentation

104:15 355:18

documented 48:9

documenting

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documents 30:15

36:10 40:22 41:17

43:11 44:14 45:11

86:14 308:2,5

333:12 349:11

370:18,19,22

371:2 405:13

411:9 415:18,21

419:3 434:9

456:10,11

document's 358:7

doing 34:19 36:7

38:16 53:7 56:19

59:12 60:17 62:22

63:19 64:18 74:8

86:16 87:3,4

160:20 166:7

167:4 174:21

250:18 290:9

325:1 334:2,8

344:19 373:22

385:11 402:11

415:10 434:10

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dose 32:11 129:9

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115:4,5,12 116:10

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152:18,20 153:9

153:17,18 154:2,7

154:9,14,16,17,20

155:1,8 157:1,17

157:21 158:1,3,5

158:10 161:2

164:17,18,20

165:1,22 167:7,12

170:8,11,11

173:10 177:19

178:1,3 179:15,18

185:17,22 186:4

191:4,5,9,11,15

191:22 192:2,3,4

192:11,19 193:1,2

193:4,5,7 198:17

198:19 199:4

200:3,5,6,10,22

205:8,10 206:3

207:2,18,21,22

209:5 210:14

211:14 212:4,10

212:14,17 213:9

213:10,18 215:3

215:10 221:3,5

225:12,15 227:7

235:14 236:19

239:8,12,14 241:6

243:14 244:4,16

245:10 246:3

247:9 249:9,10

250:6,15 252:14

254:2,15,16,17

255:19 256:1

258:1,6,20,22

265:22 266:1

267:10,14 269:3,4

270:18 271:5,6,8

276:8,9 286:20,21

293:12,15,16,18

296:4,5,17 298:20

299:16,17,20,21

300:1,3,8,9,10,12

301:19 302:5,14

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303:13,15 304:9

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317:13,15 320:11

320:12 332:19,20

333:16,18 339:20

341:22 342:14,16

342:19,21 343:6

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344:20 345:1,2,4

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345:13,16 350:11

352:13,22 353:2,3

353:5,12,13

354:16,17 356:9

358:6,19,20 359:2

359:17,19 360:1

361:4,6 362:1,11

362:13 372:18,19

375:22 376:1

379:5,10,17,19,21

380:8,10 382:21

383:8,13,16,21

384:2,3,17,18,21

385:8 387:5,12

390:10,11 394:7,8

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397:17,18 400:13

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407:15,16 408:17

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422:3,7,11,14,15

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draft 3:9 6:11

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62:16,17 65:21

68:15 81:11 82:2

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82:20 83:4,5,13

83:16,18 84:1,11

112:7,8,12 113:16

114:20 115:6

116:17 169:4,19

181:4 220:20

229:20 231:1

244:20 251:11,12

252:5,11 258:10

258:14 310:20

402:21 430:15

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drafting 17:12

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drafts 42:10 43:9

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dramatic 177:17

dramatically

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drastic 410:1

draw 20:18 212:8

251:4 274:6 319:7

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dynamic 123:19

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E

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332:10 339:9

340:12 342:4,5

359:13 364:13,21

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369:19 370:10

371:12,17,20

373:1 374:2

375:13 386:4,7

396:8 401:2

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407:1,4,8,13

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272:13 361:3

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effects 5:7,10 24:7

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28:18 29:5,7 30:7

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72:1,22 74:7 78:2

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86:2 96:17 97:5

105:6,12 107:10

107:12 108:3,15

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113:10 118:19,20

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120:17 121:9

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166:3 168:9

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171:10 173:3,4,5

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264:11 270:14

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324:20 327:22

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330:18 332:9

335:4 336:1

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347:12 365:9

366:8,19 367:13

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422:7 425:16,20

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67:3 90:1,3 92:7

95:13 99:2 101:21

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106:19 107:18

109:16,21 111:2

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161:13,19 167:13

168:4,6,14 169:6

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176:10 177:3

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183:5,15 197:10

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204:21 208:5

217:2 296:7 302:6

311:8 344:12

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388:1 392:4 404:9

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99:14 264:15

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106:9 112:2 141:7

141:16 146:21

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155:15 181:7

189:4 223:2

224:17 331:22

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established 187:2

establishes 90:7

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144:19 145:14

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160:13 164:7

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340:15,16 346:1

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367:7,11 368:3,17

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200:17 201:7

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292:22 296:7

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305:18 311:18

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329:13 330:9

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348:17 354:4

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365:7,9 366:8

367:9,11 368:12

373:9,10,17,21

378:14 384:7,20

385:21 395:11,19

397:10 411:6,16

416:22 421:16

423:12,13 429:8,9

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437:4,8,9,10

457:14

exposures 59:18

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264:10,18 278:18

312:13,19 313:14

313:21 334:7

337:16,21 338:2,4

350:9 384:14

390:2 411:15

412:1 429:19

exposure's 384:8

437:4,5

express 187:5

expressed 111:2

125:18 201:2

398:11

expressing 202:9

extend 16:20 17:5

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131:5 137:8

218:21 228:6

234:8 235:1

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368:13 369:12

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external 18:14 76:9

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278:17

extra 91:18 300:20

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extremes 165:18

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ExxonMobil 3:19

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EþT 137:3

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facing 241:4

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149:15 155:8

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207:5 239:20

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335:17 347:15

348:10 354:7

374:13 378:2

381:10 382:13

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404:15 406:19

411:22 412:3,14

factor 61:6 139:10

160:1 168:8,12

268:7 269:6

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February 18:3

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federal 2:12 6:4,13

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feed 122:17

feedback 42:8

79:15 80:1 137:15

feel 15:5 42:21 51:2

67:22 68:5 72:10

115:2 121:5 149:2

209:22 211:11

251:8 311:4

379:13,20 381:8

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440:6 450:3

feeling 205:16

feels 343:21

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FEM 237:20

female 383:14

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123:22 124:9,17

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field 100:21 255:6

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fields 231:17 233:1

234:15

Fifth 203:14

figure 24:5,13,21

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32:2 75:7,21

76:18 85:6 89:20

161:14 163:7

166:21 170:21

171:16 175:11

178:4,14 224:20

274:5 283:19

285:3 287:13

298:10 303:17

335:3,21 424:17

424:17 425:1,1,8

432:10,11,15,16

432:16 433:1

434:1,7 439:19,20

440:7,14 441:5,7

441:13,15,18,22

441:22 445:19

figures 25:3 27:8

31:1,3 121:16

224:11 318:17

427:6,8 434:3,8,9

files 174:4

fill 56:17

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mixing 187:13,20

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mode 5:5 28:21

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modification

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month 44:12 157:9

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monthly 91:1 92:9

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negotiating 182:5

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neither 139:6

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nitric 200:19

nitrogen 200:19

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NOAA/University

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noise 149:7 150:16

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nomenclature

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nonexistent 98:8

nonlinear 129:14

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nontechnical

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non-human 427:2

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numerical 143:8,13

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numerous 110:16

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nutrition 365:14

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Obama 204:21

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obese 138:7,15

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obtained 127:7

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obvious 144:18

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obviously 18:4

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occasions 93:2

occur 65:18 92:22

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occurred 92:22

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occurring 196:9

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occurs 262:16

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old/new/recent

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191:5,15 192:2,11

193:1,4 195:14

omit 356:17 358:16

once 8:1 35:8

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382:3,13 387:4

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361:21 451:10,12

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one's 87:21 285:2

one-hour 28:16

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onset 329:18,21

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onshore 188:11

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open 6:8 7:9 111:20

135:17,19 213:1

395:13,22 396:3

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openly 115:21

350:1

open-top 392:5

operate 368:2

operating 352:16

operation 117:20

opinion 111:15

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236:4 291:1

300:17

opportunities 7:12

96:12 390:1

opportunity 9:11

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118:7 123:18

140:6 152:17

158:11 167:13

173:15 205:2

208:8,22 233:12

403:6 427:18,21

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455:17

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orally 208:2

oranges 445:3

order 43:11 87:20

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original 23:11

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origins 103:13

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outcome 79:7

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outdated 236:6

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outliers 148:11,20

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output 125:15

174:6

outputs 145:8

outside 25:19 32:12

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182:18 277:21

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overall 60:11 70:9

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overarching 40:14

259:1 263:21

341:11 387:14,20

389:2 390:9 457:2

overhead 193:9,21

overinterpret

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overlap 385:6

overlay 263:3

Overlaying 263:4

overlooked 142:22

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overly 145:14

overpredict 132:12

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overpredicted

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overprediction

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oversimplifies

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overwhelmingly

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oxidant 391:3

oxidants 9:4

oxidated 329:9

oxidation 29:15

oxide 200:20

oxides 200:19,19

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ozone 1:4 3:9 5:4

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18:20 20:6 21:1

25:2,11,18,20

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37:17 39:4 42:14

46:4 47:21 48:21

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projections 404:18

prologue 36:6

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proteomic 396:14

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104:15 121:17

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202:21 226:14

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122:5 148:8 186:9

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318:6,8 326:15

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371:13 374:22

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quorum 117:5,5

quote 202:9,12,17

212:6 364:3

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radiation 421:11

radiative 406:16,21

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raise 63:9 99:21

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raised 287:6

raises 66:7 418:19

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ramification

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82:13,18 83:1,8

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109:4 119:11

124:22 126:6

127:11 128:9,19

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172:18 183:18

184:16 187:16

189:17 195:7

198:13 222:14

223:10 240:22

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294:22 295:5,7

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313:12 314:3

335:11 368:14,22

ratios 187:14,20

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RCP 405:11,14,22

REA 50:8,15 51:1,8

57:9 64:5,13 71:9

77:8,15 81:3 82:2

82:4,4,15 83:4,5

83:13 84:12 86:17

241:14,22 243:2

246:19 247:2

248:3 250:4

252:17 253:6,9

254:20 257:11

261:4,14 350:20

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409:5 432:13

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425:6,7 428:14

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434:12 436:18

440:10 441:5

442:13 444:17

446:22 451:8

453:8 454:6 456:9

realm 68:9 435:2

real-world 97:11

reanalysis 157:13

rearrangement

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REAs 261:19

reason 153:1 227:6

248:1 282:21

284:4 292:18

327:8 346:19

374:8 377:19

reasonable 68:5

96:1 104:22

164:13 329:11

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release 43:18 44:1

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120:20 194:13,18

195:10 199:16

239:7 351:3,6

403:10,22 404:4

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representativeness

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335:15 336:1

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113:13,18 123:19

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125:16,18 126:13

126:15,21 127:8

128:7 129:1,20

139:5 147:21

150:22 152:4

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203:21 204:13,17

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268:6 287:1 297:4

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372:4 377:11,13

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121:4 125:19

126:8 127:3,17

128:4 130:7 135:2

152:9 153:6 202:2

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389:17 390:3

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responsibility

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rest 26:11 115:1

131:7 230:21

267:7 318:19

390:5 391:16

394:5 400:11

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result 90:10 110:19

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105:11 127:7

141:19 150:4,10

150:12 152:7

153:16 156:7,13

157:14 172:8,22

174:10 175:3,6,22

190:2,7 191:1

195:2 196:22

198:10 201:16,19

202:15 203:17

248:6,16 257:14

263:7 264:14

265:5 272:20

273:9 276:17

284:8 324:13

327:11 384:16

389:17 395:14,22

396:9 431:9

resume 215:4

resumed 139:21

214:7 362:9

retain 201:15

rethinking 373:21

retired 11:22

return 67:13

returns 142:13

reversible 172:21

review 1:4 3:6 6:6

6:11 8:8,21 9:2

10:8 16:16 17:2

18:9,22 20:6,7

21:22 38:9 39:8

41:21 42:17 43:11

44:5,13 45:18

47:11 50:9 68:10

95:10,11 100:14

100:19 105:10

109:13,19 112:2,7

112:15 114:21

115:2 117:9

135:21 136:1

180:4 185:1

209:17 210:12,20

211:2 230:16

235:5 249:14

251:1 259:16

280:12 310:17

317:22 318:20

320:20 344:4

351:4 357:3,18

360:3,9 361:7

363:2,5 369:6,7

410:14 415:7,9

419:4 421:21

422:20 423:2

445:9

reviewed 20:18

43:17 95:15 101:6

102:12 121:20

122:8 203:9,11

235:4 261:2,22

298:20 332:21

369:16 433:17

reviewer 245:21

reviewers 76:10

211:5 310:9

reviewing 18:1

22:2 40:22 111:8

112:8

reviews 52:6 78:1

109:21 444:20

456:11

revise 180:10

450:10

revised 25:9 27:3

453:11

revision 169:7

180:15 204:22

231:4 350:8

394:11,13 437:2

revisions 3:8 19:3

114:19 180:13

229:12 440:13

revisit 66:18 448:3

revolution 402:11

reworded 281:16

reworked 391:6

reworking 441:1

re-analysis 295:22

re-emphasize

285:8

re-presentation

264:6

Rhinelander 393:8

399:3

Richard 4:7 147:2

147:4,6

richness 292:3

347:5

right 28:9,13 38:12

73:8 77:2 80:6

88:18 91:14 110:3

117:22 130:14

131:12 134:15

137:21 154:17

165:22 167:1

175:7 176:8

211:11 213:9

215:10 230:16

234:7 235:11

237:1 243:10
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279:1 287:11

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317:16 323:19

324:5 328:3

344:20 348:15

359:15 363:8

383:5,7,21 397:15

402:17 403:1

409:8,14 410:4

418:4 423:6 432:6

434:22 442:17

443:21 444:4,11

451:14 452:1

454:21 456:18

458:13

rigor 112:8

rigorous 107:7

111:16 169:21

177:4

rise 178:19

risk 3:11,23 5:9

12:1 21:14,20

41:3,7,10 42:1,7

42:10 43:5,9,18

44:6,9,17 45:6,10

45:14 46:5,10

47:6,14 48:3,9,13

48:19 49:22 50:3

50:20 51:3,10,11

51:12,15 53:18

54:3,6,8 55:5,12

55:18,22 56:4,8

56:10,19 58:14,16

59:7,11 60:10

63:20 64:2,4 65:8

65:14 66:10,20,22

67:6,7,21 68:15

68:20 69:3,6,10

69:12 70:9,14,18

75:4 86:11,19

89:22 90:1,6 93:9

96:5,14 99:3

106:19 110:8

111:4 119:12

122:18 123:22

124:2,4,13 125:5

125:7 128:11,12

128:14 136:18

139:10 158:19

162:16 174:2

177:5 178:7,11

193:12 212:1,6,7

212:12 242:21

246:9 250:22

251:16,18 269:7,8

286:12 314:18,19

330:3 351:9

362:12 364:3

365:16 366:5,17

370:21 371:1,6

374:6,8,15 376:16

382:16 385:15

416:22 429:12

risks 66:1 79:22

81:4 82:5 83:7,13

97:19

risk-based 58:17

River 231:21

Riverside 13:19

road 85:17 165:7

236:17 249:21

256:16

roadways 262:12

robust 119:6

149:11 436:3

rock 405:18

Rocky 192:8

196:14

Roger 3:22 110:7,9

110:11 114:17

115:15 116:20

117:8 118:1 157:7

177:8

role 5:13 96:10

111:8 119:4

128:14 146:22

220:1 321:13

330:22 344:12,14

344:16 435:4

roles 105:16

roll 52:9 85:7,12

rollback 48:16 52:4

52:17 53:3,15

58:8 84:14,17,19

223:22 256:17,18

257:16 266:19,19

267:5

rollbacks 68:19

rolled 85:20 86:4

rolling 84:13 86:1

rolls 236:14

room 11:14 17:8

18:12 164:22

214:5

root 274:15 392:11

roots 393:10

rotation 199:6,15

roughly 175:18

362:2 457:21

round 10:8 66:16

271:20 274:13

278:6 310:20,20

route 63:4

routinely 211:18

212:13

row 149:20 394:9

440:16

RTP 17:10

rule 44:20 237:7

326:16

ruled 95:22 99:13

104:22

rules 123:9

run 270:15 405:21

running 188:18

329:10

rural 93:21 175:8

199:19

Russell 1:20 8:11

221:5 225:15

256:1 407:16

438:11

S

s 283:3

SAB 2:13 8:4,14

15:17

Sacramento 53:22

safety 78:4,10

161:20 169:16

286:6

sake 26:17

sakes 349:13

Salon 1:11

Sam 166:10 191:11

195:14 199:16

Samet 1:13,15 3:7

8:15 9:6 11:9,10

11:16 14:14 16:20

33:22 36:2 38:18

40:11 60:12 62:18

63:8 66:15 70:19

71:13,21 73:16

75:2 76:2 77:1

80:3 84:8 86:8

87:13 88:7,18

89:9 91:11,17

93:13 94:2 100:10

101:16 104:3

108:21 109:10,17

110:5 114:17

115:4,12 116:18

118:2 122:11,21

123:6 128:16

135:11 136:15

137:18 139:14

140:1 146:7 147:1

152:18 153:17

154:14,17 157:1

158:5 164:17,20

167:7 173:10

177:19 178:1

179:15,18 185:17

185:22 191:4,9

192:3 193:5

198:17 200:3,6

205:8 207:18,22

210:14 212:4,14

213:9,18 215:3

221:3 227:7

235:14 236:19

239:8,12 241:6

244:16 246:3

249:9 250:6

252:14 254:15

255:19 258:1,20

265:22 267:10

269:3 270:18

271:6 276:8

286:20 293:12,16

296:4,17 300:1,8

301:19 302:14

303:10,13 304:9

306:1 317:13

320:11 332:19

339:20 342:14,19

343:6 344:15

345:1,4,7,10,13

350:11 352:22

353:3,12 354:16

357:12 358:20

359:17 361:4

362:1,11 372:18

375:22 379:5,17

380:8 382:21

384:2,17 385:8

387:5 390:10

394:7 400:14

401:16 402:7

407:15 408:17

419:14 422:19,22

426:8 428:9

433:11 438:10

439:17 441:3

442:22 444:14

445:13,16,22

447:16 448:21

449:7 450:13

451:12,19 452:1,6

453:3,14 454:14

454:20 455:21

456:20 457:2

459:8

sample 62:4 96:11

371:18

Samuel 4:19 186:2

San 192:8

Sasha 406:20

satellite 159:22

160:2

saturation 328:1

saving 68:7
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Sax 4:14 167:10

170:8

saying 22:17 37:6

67:20,22 68:7

69:5 102:21

146:10 209:9

227:3 241:7 243:1

244:8 278:12

323:6 326:5 349:9

352:16 370:10

374:14 390:12

402:4 411:13

426:13 428:18

454:15 456:9

says 27:20 156:5

239:7 297:17

349:13 400:22

408:18 421:2

437:8 444:12

scale 47:16 48:18

48:20 49:8,17

56:8 57:18,19

85:4 94:16 95:9

102:19 134:11

151:17 167:5

222:19,20 226:15

226:17 227:4

239:1 240:5,15

389:7,20 443:2

scales 95:4 101:1,5

101:6,10 103:14

240:14,21 332:12

405:16

scanned 375:4

scatter 126:18

151:10 176:19

scatter-shot 38:10

scavenging 178:21

scenario 163:22

164:2 232:13

233:5,10 236:8

scenarios 130:8

405:7,10,11,14,22

schedule 15:16

16:7 41:20 42:18

43:3,4,13 44:21

447:13,17 455:13

schedules 458:4,8

Schelegle 173:9

schema 370:8

schematic 25:14

scheme 101:12

schemes 101:3

102:7

Schnell 231:21

school 12:7 46:19

46:20 200:12

Schwartz 228:1

science 3:9 6:12

8:18 9:3 12:20

13:13 18:19 19:21

20:16,17 22:21

68:3,4 111:10,10

111:12 118:8

157:8 221:21

229:1 234:21

245:13,18 246:1

249:16 254:3,9,13

254:19 256:21

268:13 308:15

309:12,15 339:4

349:4

Sciences 3:19 4:11

94:5,9 105:8

109:12 158:9

186:7

scientific 1:3 6:6

8:20 9:6 21:12

66:2 95:10,11,20

111:17 112:1

215:18 243:7

269:22 308:16

344:17 356:18

357:22 428:21

scientifically 107:7

114:22

scientist 13:6 34:12

179:21 245:3

scope 43:16 50:11

50:14

Scott 2:17 3:14

41:12 42:3 59:3

scrap 441:17

screen 149:19

189:2

Screening 169:18

scrutiny 130:2

203:11 382:18

se 139:10 373:18

430:8

search 291:20,21

seasonal 121:14

140:19 185:9

227:18

seasonality 120:11

seasons 141:8

seats 215:4

second 6:11 17:22

28:9 33:1,10,19

42:9 43:9 44:9,11

47:1 51:14 52:1

52:15 53:11 54:6

55:15 56:11 57:6

57:20 58:6 61:20

62:17 65:21 82:15

82:15,20 83:3,5

83:16 84:1,11

108:6 112:7

132:17 143:18

150:1 154:11

169:19 181:4

202:5 220:20

252:5 309:17

329:18 366:7

419:7

secondary 29:15

41:16 46:9,12

49:16 53:9 57:10

80:21 83:11,17

426:4

secondly 58:22

112:19 120:14

seconds 91:18

235:16 306:6

secretion 295:7

section 25:9 34:14

34:19 35:12

203:15 216:22

217:13,22 225:7

225:10,13 229:14

230:7 237:21

238:14 240:4

262:4,5 274:5

277:3,4 285:8

292:7 313:22

336:17,17 337:14

344:12 357:18

367:9 380:20

388:15 396:12

397:19 398:15

400:10 407:18

412:18 427:19

428:2,5

sections 25:3,5,7,8

27:3 32:17 111:15

226:6 230:2

242:18 247:21

261:8 264:12

305:18 307:13

333:9,10 337:7,13

368:8 369:11

388:21 389:3

393:3

section's 226:5

see 14:14 15:4

18:14 21:16 23:15

26:1 33:22 38:22

39:7,10,11 40:20

42:18 43:6,15

44:1 57:3 65:2

67:14 70:19 71:7

71:22 72:1 73:1

80:10 84:13 85:21

86:14 88:2,20

89:4,6 119:19

121:10 123:7

126:16 128:18

138:3 144:8

148:18 150:14

153:15 156:13

163:11 175:11

176:3,6,13,18

191:21 199:9

207:19 211:12,15

212:11,11,13,21

223:6,12,13 224:9

225:20 235:18

238:12 241:10

242:14,14 245:1

251:19 255:20

256:21 258:3

261:1 262:13

264:12 267:2

270:20 278:15,16

280:10 281:12,13

282:6,7 283:12

284:1,19 285:18

286:10 289:8

292:15,20 296:4

296:17 298:18

303:10 306:10

316:9 330:13,21

333:8 338:5,10

339:21 340:15

347:13 348:13

357:21 377:18

379:15 387:17

398:20 399:17

402:16 417:11,17

421:20 422:9

430:12 438:19

440:15 447:6

449:8,8 452:12

458:2,11,16

seeing 42:1 56:18

87:2 133:4 143:2

176:9 178:13

205:20 223:16

227:6 269:15

304:2

seek 252:2

seeking 36:4,9

359:20

seen 95:4 118:8

161:1 174:13

281:9 412:11

sees 187:13

select 361:16

selected 49:13,14

105:9 114:13

348:20

selecting 54:9

selection 282:22

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sending 318:2,3

senior 104:5 186:5

sense 59:21 273:3

273:19 314:7

321:18 323:21

326:20 342:6

363:2 365:15

369:4,17 379:17

417:5 442:14

444:13

sensing 391:1

446:1

sensitive 138:22

139:7 269:18

287:2 325:13,20

326:1,7 365:22

374:10 380:16

393:17

sensitivities 62:17

sensitivity 55:17

56:13 57:6 61:19

138:21 269:6

292:8,8,13 295:16

366:10,18 374:11

374:12 430:4

sensor 391:2,4

sent 340:1 455:3

sentence 88:9

316:16 399:11

sentences 272:5

279:3

separate 154:6

301:21 302:4,8

393:5,6

separately 60:10

separation 373:9

September 17:22

204:20 430:16

sequenced 91:13

sequestration

393:4 394:1

series 124:6 228:4

serious 345:5

serve 9:12 128:10

served 18:13 102:5

110:16 116:12

117:12

serves 250:20

service 9:9,14 50:3

57:15 110:14

services 83:14

SES 368:2 375:12

381:1,5,14

session 16:3 458:15

sessions 7:6

set 33:19 52:7,11

189:5 257:15

293:5 297:21

298:2 300:20

304:19 362:4

364:16,18 370:2

434:8

sets 89:21 250:12

372:11

setting 68:21 70:15

86:20 120:10

241:13 247:3

253:16 322:12

settings 262:12

311:16 322:18

seven 126:21 127:8

157:6 240:22

354:10 381:4

398:7

severe 72:15

324:22

severely 105:18

severity 72:14

172:21 346:9

439:22

sex 151:1 380:12,14

380:20 382:22

383:2,4,6,8,13,20

sexist 380:17

shade 440:6

shading 144:21

shale 233:17

234:14

shallow 282:4,7

290:10,14

shaped 208:10

shelter 162:9,10,11

she'll 45:5

shift 113:7 254:8

shoot 435:10

shore 328:9

shored 273:5

short 6:9 81:16

84:4 100:2 105:4

109:5 121:8,11

148:4 156:21

240:15 259:20

267:21 312:18

313:8,21,21

319:22 328:13

331:20 332:4,8

335:6,7 338:3

342:3 345:22

349:1 421:3

423:11 429:9

431:19 432:7

448:5 449:14

shorter 305:6

402:20 431:2,21

short-term 5:7

30:6 47:21 49:10

79:19 81:22 121:4

141:4

shot 277:21

show 30:15 107:17

133:8 150:13

152:8 171:17

172:7 175:3 177:9

177:21 187:8

188:11,17 191:20

192:16 199:7

219:18 222:14

266:21 285:4

286:4 313:3 330:1

354:22 382:14

385:22 395:14

398:3 405:5 407:4

444:18 445:6

showed 27:9

105:12 149:5

150:10 151:20

339:5 438:4

showing 43:13

53:12 105:14

shown 34:8 43:1

90:3 91:14 92:15

108:13 134:10

161:14 204:11

439:19

shows 42:19 92:2

99:15 141:14

143:14 149:20

177:16 189:14

199:22 231:16

284:7,20 287:13

295:13 398:7

404:4 413:12

Shprentz 4:2 118:4

118:6 122:12

123:2

shrift 345:22 349:1

429:9

shrink 436:21

shy 251:12

side 83:17 88:14

175:6,7,22 176:8

245:4 248:8

396:22 440:3

sidebar 232:6

233:12

sigmoid-shaped

129:10

sign 244:8

signal 188:15

signals 160:18

signed 15:1 40:13

significance 64:22

107:19 149:8

171:18 325:5,6

significancy 201:16

significant 17:1

18:17 20:21 72:5

92:12 108:15

144:7 148:3,6

150:10 151:5,22

152:4,10 156:8,20

161:9 162:3 172:3

172:7,14 186:12

190:22 197:14,18

201:13 207:10,11

281:20

significantly

184:10

silly 349:7

similar 83:11 84:20

106:14 124:12

138:3 157:22

188:19 228:16

397:2 443:2

similarities 203:16

203:19 292:17

similarly 131:7

169:4

simple 71:2 124:3

145:1 232:12,21

288:22 364:4

378:2,3 386:17

406:15,16 425:2

simplified 233:5,10

simply 144:15

181:6 185:9

245:12,17,22

301:17 337:12,12

361:20 401:9

410:17

simulate 82:9

simulated 141:21

simulating 83:15

simulations 82:8

83:4 261:9 272:21

Simultaneous

139:13

simultaneously

395:5

single 39:4 124:7

135:6 161:4,10

184:3 309:5

312:13 314:2

352:15 356:11

399:4

SIP 93:10 236:16

SIPS 68:8

Sit 208:6

site 27:1 175:8,18

175:21 187:5

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siting 120:11

sitting 138:17

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situation 100:16

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375:8 404:20

situations 228:17

six 111:6 114:1

118:7 131:16,20

132:5 156:4

204:20 324:16,18

354:10 393:9

six-hourly 142:6

size 69:7 96:11

176:7 241:2

371:18

sizes 62:4

skinny 139:9

skirt 385:7

slash 373:1

slice 131:9

slide 27:13 32:19

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slides 45:14 50:6

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slight 107:17 436:5

slightly 153:16

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slip 355:16

slipped 312:16

355:14

slope 196:14 266:7

slot 15:18

slow 439:6 447:13

slows 418:18

sluggish 399:18

400:3

smack 287:12

small 24:3 97:19

124:10 127:4

131:9 152:3

213:12 222:19,19

266:6 322:10

325:14 330:5

373:5 398:22

406:20 407:2,8,13

408:3,4,14 409:1

411:8 419:2

smaller 150:7

262:16

Smith 2:19 4:7

41:15 56:2 90:3

147:3,5,6 153:9

154:2,9,16 170:11

Smith's 155:1

smog 234:21

smoke 144:20

smoker 373:4

Smokies 398:17

smoking 351:3,5

smooth 218:22

social 365:14

Society 329:19

331:7

soft 386:13

soil 159:11 219:21

solely 401:8

solid 292:18

solution 302:3,15

303:11 417:8

solve 283:20

somebody 40:13

298:16 387:2

416:21 433:20

Somers 398:1

something's 319:14

355:13

somewhat 37:4

131:21 156:16

252:8 256:6 261:8

326:18

Sonya 4:14 167:10

sophisticated 293:3

sorely 216:7

sorry 29:19,22 59:2

91:11 100:22

115:16 132:16

138:11 196:20

225:12,16 421:17

422:3,10,13

441:15,15

sort 38:10 63:11

73:18 79:8 101:22

102:15 138:19

149:11 160:20

210:21 221:8

222:17 223:6,7

230:10,17 241:21

242:19 243:7

244:17 245:5

246:5 249:8

252:15,20 253:8

253:20 255:22

256:9,17 258:15

267:20 276:13

283:9 298:17

300:10 304:11,18

321:9 323:4,11,12

323:15 326:17

327:22 328:9

330:13 332:11

335:1 337:15

340:3 353:6

376:12,19,20

377:15 378:3

379:17 380:15

386:15 409:9

412:17 414:1

417:20 418:9,18

418:19 425:4

426:5 429:20

431:13 440:18

442:15 457:15,18

sorting 457:14

sorts 375:16 425:9

sounds 226:12

source 63:20,22

74:13 120:18

142:1 146:5

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288:15 298:7

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warn 152:15

warning 103:22

warrant 112:21

washes 160:18

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249:3,5 272:6,10

272:13 276:1,3

280:14 286:6

332:22 343:12

407:19 413:14

419:9 449:16

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wave 31:14 323:20

323:21 336:13,22

337:5,11,11

353:15 354:5,9

way 19:13 73:1

77:22 85:6 123:3

130:13 132:13

142:12 151:13

155:20 160:19

181:7 197:16

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218:10 221:18

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236:12 254:7,14

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271:2 276:18

302:7 310:3 321:1

321:4 323:12

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weakened 326:20

weaker 122:2

weaknesses 168:18

weapons 196:6

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288:11 382:12

weekend 382:15

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314:11 327:7

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26:13 35:3,22

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47:3,8 49:21,22

50:2 52:6 55:2

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110:6 154:17

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140 4:6 232:2

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15-minute 362:6

154 4:9

158 4:11

16 3:9 7:15 15:1

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170 4:14

1700 162:6

173 4:16

179 4:18

18 124:18 128:8

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18-hour 150:8

1840 163:14

186 4:19

19 280:18

193 4:21

1960s 196:7

1970 177:12 374:9

1986 349:13 358:4

1988 283:20

1990 223:12

1990's 285:22

1995 223:13

1996 388:8

1997 187:3

1998 349:19

2

2 5:19 20:14,20

22:20 23:8,13,14

24:6,14,22 33:9

38:6 80:20 81:1

119:18 187:19

229:14 261:21

263:1,14 264:5,5

265:8,19 268:4

291:12 335:19

362:5 409:19

417:9 418:3 433:6

438:13 439:8

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2-3 418:14 439:19

2.1 445:19

2.2-2 418:14

2.3 75:8

2.4 417:11

20 72:7 108:10,17

131:17 362:2

404:4

200 4:23

2000 74:1 223:13

2001 93:2 193:22

194:8 405:8

2002 187:5

2003 236:16

2004 102:4

2006 47:3,4 48:15

48:16 49:4,19

57:13 122:9 388:8

392:17 394:19

442:19 443:10,15

2007 49:7,20 90:5

90:22 197:19

403:11

2008 42:14 47:4,5

48:16,16 49:5,20

57:13 120:20

177:12 413:16

2009 96:6 173:9

197:19 237:14

238:15 398:7

2010 47:3,5 48:15

48:16 237:12

2011 172:3 204:20

238:16 430:16

442:20

2012 1:9 44:13

2013 44:15,17,18

44:19 99:4

2014 42:19 44:20

208 4:24

21st 405:7

215 5:2

22 92:16

23 124:21

237 442:7

24 121:12 260:3

315:2 316:20

25 282:8 362:7

258 5:4

27 413:16

270 5:6

3

3 5:2 25:7 26:20

34:8 35:4 81:2

120:2 189:2

192:18 230:9,21

235:2,3 247:19

248:20 249:6

262:1,8 263:4

265:1 453:20

3-58b 224:20

3.4 25:7 34:14

217:13

3.5 172:18 235:18

3.6 25:9

3.6.12 417:12

3.6.3 216:22

3.7.2 240:4

3.9 25:8 34:19 35:6

225:7,7

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3:36 362:10

30 91:18 93:6 154:5

278:3 318:16

353:20 354:15

415:20 418:16

30-some 382:10

305 5:8

31 318:17

33 401:20

35 90:4 91:8 124:18

128:8 131:10

133:6 381:10

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35-year 131:8

362 5:9

37 163:15

387 5:11

39 196:21 197:9

395 238:22

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5-14 287:6

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5-50 282:13

5-65 289:17

5-68 283:16

5-8 279:20

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60 91:9,20 118:15

118:19,21 133:8

207:9 224:8,8

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171:19,22 172:2

172:13 195:3

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65 122:19 199:13

65ppb 187:17

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316:22 326:9

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70 92:22 199:10

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70ppb 199:3

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74 266:15,22

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75ppb 185:19

78 163:16

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816 380:13

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9 1:9 5:11 24:22

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9-6 283:19

9.3 394:17

9.4.2 397:19

9.4.3.2 399:9

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90ppb 173:8

90s 327:21

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94 3:19

9431 392:13

9432 392:13

95 171:15