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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 + + + + +

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 OZONE REVIEW PANEL

 + + + + +

 PUBLIC MEETING

 + + + + +

 TUESDAY, SEPTEMBER 11, 2012

 + + + + +

 The meeting convened in State

Ballroom A and B of the Marriott City Center,

500 Fayetteville Street, Raleigh, North

Carolina, at 9:00 a.m., Jonathan Samet, CASAC

Chair, presiding.

CASAC MEMBERS PRESENT:

JONATHAN M. SAMET, Chair

GEORGE A. ALLEN

ANA DIEZ-ROUX

ARMISTEAD (TED) RUSSELL

HELEN SUH
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PANEL MEMBERS PRESENT:

ED AVOL

MICHELLE BELL

JOSEPH D. BRAIN

DAVID CHOCK

WILLIAM MICHAEL FOSTER

DAVID GRANTZ

JACK HARKEMA

DANIEL JACOB

STEVEN KLEEBERGER

FREDERICK J. MILLER

HOWARD NEUFELD

JAMES ULTMAN

SVERRE VEDAL

PETER WOODBURY

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF

PRESENT:

ANGELA NUGENT, Designated Federal Officer

VANESSA VU, Director, SAB Staff Office

JAMES BROWN, ORD/NCEA

BRYAN HUBBELL, OAQPS

JOHN LANGSTAFF, OAQPS

ZACHARY PEKAR, OAQPS

MARY ROSS, ORD/NCEA

HEATHER SIMON, OAQPS

JOHN J. VANDENBERG, ORD/NCEA

LYDIA WEGMAN, OAQPS

KAREN WESSON, OAQPS
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 T-A-B-L-E O-F C-O-N-T-E-N-T-S

 PAGE

Convene Meeting

 by Dr. Angela Nugent. . . . . . . . . . .6

Welcome

 by Dr. Vanessa Vu . . . . . . . . . . . 11

Review of Agenda

 by Dr. Jon Samet. . . . . . . . . . . . 14

Integrated Science Assessment

 by Dr. John Vandenberg. . . . . . . . . 17

 by Dr. James Brown. . . . . . . . . . . 22

Public Comment

 by Dr. Sonia Sax. . . . . . . . . . . . 38

 by Mr. Will Morgan. . . . . . . . . . . 43

 by Dr. Stephanie Shirley. . . . . . . . 49

 by Dr. Nicole Downey. . . . . . . . . . 55

 by Mr. Samuel Oltmans . . . . . . . . . 67

 by Dr. Allen S. LeFohn. . . . . . . . . 72

 by Mr. Christopher Emery. . . . . . . . 88

 by Dr. Julie Goodman. . . . . . . . . . 93

 by Dr. Deborah Shprentz . . . . . . . .101

Panel Discussion of Integrated Science

Assessment

Preamble, Chapter 1 (Summary) and

Chapter 2 (Integrative Overview)

 by Dr. Christopher Frey . . . . . . . .108

 by Dr. Joseph Brain . . . . . . . . . .127

Chapter 3 - Atmospheric Chemistry

 by Dr. Daniel Jacob . . . . . . . . . .135

 by Mr. George Allen . . . . . . . . . .145

 by Dr. Ted Russell. . . . . . . . . . .147

 by Dr. David Chock. . . . . . . . . . .149
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Chapter 4 - Exposure

 by Mr. Ed Avol. . . . . . . . . . . . .162

 by Dr. David Chock. . . . . . . . . . .163

 by Dr. Helen Suh. . . . . . . . . . . .164

Chapter 5 - Dosimetry

 by Dr. Jack Harkema . . . . . . . . . .165

 by Dr. Fred Miller. . . . . . . . . . .169

 by Dr. James Ultman . . . . . . . . . .170

Chapters 6 - 7 - Health Effects

 by Dr. Michelle Bell. . . . . . . . . .176

 by Dr. Ana Diez-Roux. . . . . . . . . .178

 by Dr. Michael Foster . . . . . . . . .180

 by Dr. Sverre Vedal . . . . . . . . . .181

Chapter 8 - Populations at Risk

 by Dr. Ana Diez-Roux. . . . . . . . . .194

 by Dr. Jack Harkema . . . . . . . . . .197

 by Dr. James Ultman . . . . . . . . . .198

 by Dr. Steven Kleeberger. . . . . . . .200

Chapters 9 - 10 - Environmental Effects

 by Dr. Howard Neufeld . . . . . . . . .207

 by Dr. David Grantz . . . . . . . . . .213

Lunch . . . . . . . . . . . . . . . . . . . .223

Overview of the NAAQS Review Process and

Schedule

 by Ms. Lydia Wegman . . . . . . . . . .224

Overview of the Risk and Exposure Assessments

and Policy Assessment

 by Dr. Bryan Hubbell. . . . . . . . . .237

Agency Presentation on Health Risk and

Exposure Assessment

 by Ms. Karen Wesson . . . . . . . . . .278

 by Mr. John Langstaff . . . . . . . . .278

 by Dr. Zachar Pekar . . . . . . . . . .294
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Public Comments

 by Sonja Sax. . . . . . . . . . . . . .302

 by Jon Heuss. . . . . . . . . . . . . .307

 by Richard Smith. . . . . . . . . . . .313

 by Samuel J. Oltmans. . . . . . . . . .319

 by Allen Lefohn . . . . . . . . . . . .323

 by Christopher Emery. . . . . . . . . .328

 by Julie Goodman. . . . . . . . . . . .336

 by Anne Smith . . . . . . . . . . . . .342

 by Deborah Shprentz . . . . . . . . . .348

Panel Discussion of Health Risk and Exposure

Assessment

Chapters 1 - 3 - Introduction, Conceptual

Model and Scope

 by Dr. Fred Miller. . . . . . . . . . .354

 by Dr. Ted Russell. . . . . . . . . . .357

 by Dr. Joseph Brain . . . . . . . . . .357

Chapter 4 - Air Quality

 by Mr. George Allen . . . . . . . . . .378

 by Dr. Daniel Jacob . . . . . . . . . .382

 by Dr. David Chock. . . . . . . . . . .386

Chapter 5 - Population Exposure

 by Dr. Helen Suh. . . . . . . . . . . .400

 by Dr. Michelle Bell. . . . . . . . . .410

 by Dr. Ana Diez-Roux. . . . . . . . . .415

Adjourn . . . . . . . . . . . . . . . . . . .423
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1 P-R-O-C-E-E-D-I-N-G-S

2 (9:02 a.m.)

3 DR. NUGENT: Good morning

4 everyone. I'm Angela Nugent. And I am the

5 designated federal officer for the Clean Air

6 Scientific Advisory Committee, the CASAC Ozone

7 Review Panel, at this meeting.

8 I'd like to make a few remarks in

9 my capacity as designated federal official to

10 open this meeting, because it is a formal

11 Federal Advisory Committee Act meeting, formal

12 FACA meeting.

13 The CASAC is an independent expert

14 federal advisory committee, chartered under

15 the authority of the Federal Advisory

16 Committee Act. The CASAC is empowered under

17 the Clean Air Act to provide independent

18 advice to the EPA Administrator on the

19 technical basis for EPA's National Ambient Air

20 Quality Standards.

21 So the Federal Advisory Committee

22 Act, or FACA, requires that CASAC meetings do
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1 several things. They have to be announced in

2 the Federal Register so that the public knows

3 that they're happening. Substantive

4 deliberations of this panel and interactions

5 with the public and the Agency need to occur

6 when a designated federal official is present.

7 So no substantive off line

8 conversations pertaining to the subject matter

9 of these deliberations can happen, except in

10 these public meetings or when the designated

11 federal officer is present to record the

12 substance for the record.

13 FACA also requires that public

14 meetings provide an opportunity for public

15 comment. There are, on the agenda, four

16 different public comment periods noted for our

17 three day meetings, where the public have

18 registered in advance to provide oral

19 comments.

20 And there are also two other

21 opportunities noted on the agenda. Late

22 Wednesday afternoon and late morning on
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1 Thursday, where the public can provide

2 additional, different clarifying comments.

3 And I will make these remarks

4 tomorrow morning, and also on Thursday. 

5 Members of the public who wish to contribute

6 those additional, different clarifying

7 comments, please contact me so I can, you

8 know, develop a list of who's talking when,

9 and get that organized.

10 Let's see. Members of the public

11 have also provided written comments in

12 advance. Some way in advance, and some just

13 recently. And we're getting all those posted

14 on the CASAC website for the meeting. And I

15 will make sure that panel members have them.

16 The SAB Staff Office will also be

17 preparing minutes of this meeting to summarize

18 the discussions and the action items in

19 accordance with the requirements of FACA. SAB

20 Staff Office will work with the CASAC Chair to

21 have the official minutes certified so they

22 can be posted on the CASAC web site.
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1 I'd like to thank members of the

2 panel for providing the information that's

3 allowed my office to review and determine that

4 they -- to review their information and

5 determine in advance that they're in

6 compliance with the Ethics in Government Act,

7 and have no conflict of interest or appearance

8 of lack of impartiality associated with the

9 deliberations of this meeting.

10 As a result of that review we've

11 made several determinations. And we've asked

12 Dr. Michelle Bell and Dr. Jonathan Samet not

13 to comment on the use of their studies as the

14 basis for the Health Risk and Exposure

15 Assessment, and its implications for the

16 Policy Assessment.

17 So they will not participate in

18 those deliberations. But they're available as

19 resources to address clarifying questions that

20 other panel members may have about their

21 studies, should those questions arise.

22 Before I introduce Dr. Vanessa Vu
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1 for her opening remarks, and Dr. Samet to get

2 going on the substantive deliberations today,

3 I'd like to make two important housekeeping

4 comments.

5 The first one is that for members

6 of the public and representatives of the

7 Agency participating by phone who have not

8 contacted the SAB Staff Office directly about

9 their participation, please email me so I can

10 make a record of who's participating.

11 That's part of my job and the job

12 of our office, to document who's participating

13 in these meetings, even if they're just

14 listening. So my contact information's on the

15 CASAC web site for this meeting. It's

16 nugent.angela@epa.gov.

17 The other piece of housekeeping

18 pertains to audibility. Anyone participating

19 by phone on this teleconference, who is

20 listening in, I ask you to put your phones on

21 mute.

22 And I know there may be a few
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1 public commenters who will be participating by

2 phone. We'll be asking them to use a handset,

3 not a speaker phone when they speak.

4 So with that, I'd like to turn

5 first to Dr. Vanessa Vu for her opening

6 remarks. And then Dr. Jon Samet to take us

7 into the Agenda. Thanks.

8 DR. VU: Thank you, Angela. Good

9 morning everyone. As Angela introduced me, my

10 name is Vanessa Vu. And I'm the Staff

11 Director of the EPA Science Advisory Board.

12 I would like to welcome everyone

13 to the public meeting of the Ozone Review

14 Panel of the EPA Clean Air Scientific Advisory

15 Committee, or CASAC. The charter of CASAC,

16 augmented with invited experts, will review

17 four draft technical documents as part of the

18 Agency review of the National Ambient Air

19 Quality Standards, or NAAQS for Ozone.

20 On behalf of the Agency I'd like

21 to thank Dr. Jon Samet, distinguished members

22 of the CASAC, and invited experts serving as
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1 consultants to the CASAC, for your time and

2 public service in providing independent advice

3 to the Administration regarding the NAAQS for

4 Ozone.

5 I'd also like to extend our thanks

6 to EPA officials from the Office of Research

7 Development, led by Dr. John Vandenberg. And

8 Ms. Lydia Wegman from the Office of Air

9 Radiation, and her colleagues for today's and

10 tomorrow's presentations regarding the

11 Agency's draft technical documents.

12 All of the EPA representatives

13 will be here throughout the next three days to

14 respond to any clarifying questions that the

15 panel may have.

16 I want to remind you, as Angela

17 said, the public input is a critical component

18 of the advisory process, as required of the

19 Federal Advisory Committee Act, or FACA, and

20 EPA policy.

21 I would like to thank today's

22 public speakers, as well as the next two days,
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1 and interested members of the public who

2 submitted written comments for the CASAC

3 consideration.

4 I ask that the CASAC fully

5 consider public comments as you discuss and

6 deliberate your responses to EPA charge

7 questions and any relevant technical issues of

8 the CASAC team as appropriate. I look forward

9 to panel discussion and deliberation in the

10 next three days.

11 And finally, I'd like to extend my

12 thanks to my staff and my contracted personnel

13 for convening the meeting, this public

14 meeting.

15 Special thanks go to Dr. Holly

16 Stallworth, who is unable to be here today. 

17 She's responsible for planning this meeting. 

18 And of course, Dr. Angela Nugent for serving

19 as the federal officer of this public meeting. 

20 And with that I'd like to turn the meeting

21 over to Dr. Jon Samet.

22 CHAIR SAMET: Thanks Angela and
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1 Vanessa. And welcome everybody to this CASAC

2 odyssey. I think two and a half day meeting,

3 with the heaviest set of documents yet carried

4 to CASAC.

5 And I congratulate those of you

6 have actually carried all of the documents

7 here, Chris. And maybe Sverre. Did you carry

8 all those documents?

9 DR. VEDAL: Yes, I did, Jon.

10 CHAIR SAMET: You are powerful. 

11 So I think everyone knows that we have a very

12 crowded agenda, beginning with today's review

13 of the third draft ISA.

14 And then moving on to the Health

15 Risk and Exposure Assessment today. And of

16 course continuing on into Wednesday with that

17 document. Then the Welfare Risk and Exposure

18 Assessment. And finally Thursday to the

19 Policy Assessment.

20 So we do have a busy agenda and

21 some big documents to review. So let me start

22 by asking the committee, let's make a round of
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1 introductions, maybe, Ted, starting with you.

2 DR. RUSSELL: Ted Russell, Georgia

3 Tech.

4 MR. ALLEN: George Allen, NESCAUM.

5 DR. GRANTZ: David Grantz,

6 University of California at Riverside.

7 DR. WOODBURY: Peter Woodbury,

8 Cornell University.

9 DR. NEUFELD: Howard Neufeld,

10 Appalachian State University.

11 DR. VEDAL: Sverre Vedal,

12 University of Washington.

13 DR. BELL: Michelle Bell, Yale

14 University.

15 DR. HARKEMA: Jack Harkema,

16 Michigan State University.

17 DR. MILLER: Fred Miller,

18 Independent Consultant.

19 DR. ULTMAN: Jim Ultman, Penn

20 State University.

21 DR. KLEEBERGER: Steve Kleeberger,

22 National Institute of Environmental Health
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1 Sciences.

2 DR. ROSS: Mike Foster, Duke

3 University Medical Center.

4 DR. BRAIN: Joe Brain, Harvard

5 School of Public Health.

6 MR. AVOL: Ed Avol, University of

7 Southern California.

8 DR. JACOB: Daniel Jacob, Harvard

9 University.

10 DR. CHOCK: David Chock,

11 Independent Consultant at University of

12 Michigan.

13 DR. SUH: Helen Suh, Northeastern

14 University.

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

16 University of Michigan.

17 DR. FREY: Chris Frey, North

18 Carolina State University.

19 CHAIR SAMET: Okay, good. Thanks. 

20 So why don't we go ahead then to hear from EPA

21 presentation on the revised ISA. I will say

22 that certainly a lot of revisions were done.
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1 I think most of us probably found

2 the redline version to be very helpful in

3 sorting out what changes were actually made in

4 this very extensive document. So I think that

5 was a useful addition to what you usually

6 provide us, John. Thank you.

7 DR. VANDENBERG: Good. Thank you

8 very much. My name is John Vandenberg, and

9 I'm the director of Research Triangle Park

10 Division of the National Center for

11 Environmental Assessment.

12 And I would like to extend my

13 appreciation to the CASAC members for their

14 sustained support, their helpful comments,

15 that we have taken and reviewed both the

16 consensus comments as well as the individual

17 comments as we have developed this third

18 draft.

19 I'd also like to extend my

20 appreciation to the public for their comments. 

21 And again in the same manner, we very

22 carefully considered those as we were making
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1 this third draft of the Integrated Science

2 Assessment.

3 And also to Drs. Vu, Nugent and

4 Stallworth for their help in setting the

5 meeting up. In particular, I'd like to thank

6 Jim Brown, who's sitting next to me here, as

7 the project manager for the ozone assessment.

8 He's been a central figure for us

9 in terms of continually pulling the

10 information together, looking at where we have

11 been making recommendations, and how we've

12 revised the document. And the EPA staff that

13 is largely to the left here, that has worked

14 on this, led by Mary Ross, the Branch Chief.

15 So what we'd like to do very

16 briefly this morning is just highlight a few

17 of the changes that were made. I'm glad to

18 hear that the redline document was helpful. 

19 Sometimes that's very challenging to look at.

20 Because as you move things around

21 we used a different color scheme to show what

22 was moved, versus what was actually added and
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1 deleted. And once you get in your head what

2 the protocol is, hopefully that was useful to

3 you.

4 Certainly it's a challenging

5 document because it's very substantial in

6 length. But it's also complicated. There's

7 a lot of information there that takes a good

8 bit of energy to review. And so I appreciate

9 the efforts of the members as well as the

10 public.

11 So where we are today is reviewing

12 the document. And our anticipation is to try

13 to finish it up in a timely manner. Of course

14 that will depend upon the nature of the

15 comments that we receive today and tomorrow.

16 The ozone team, as I mentioned,

17 includes the individuals within the National

18 Center for Environmental Assessment, as well

19 a number of external authors that we have

20 brought in.

21 What is not shown here is the

22 number of other individuals within EPA that we
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1 also consulted with in our Office of Research

2 and Development as we've developed this third

3 draft. We brought in a number of other

4 individuals for detailed discussions. In

5 particular about the ozone mortality question.

6 The changes in the document did

7 not include any changes to the chapters. And

8 so I would just reiterate the structure of the

9 document is shown here.

10 And then finally, just to

11 highlight a few of the major changes, and Jim

12 Brown will walk through these, we made

13 particular attention to the consensus letter

14 and the recommendations found there.

15 And I think we find that

16 throughout the development of the ISAs, this

17 one, as well as the lead document that we're

18 working on now and others, there's always a

19 challenge to produce more and more

20 integration.

21 The use of information from one

22 chapter that helps inform and provides
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1 insights and information to other chapters,

2 requires a lot of staff time to talk across

3 disciplines, across individuals, across

4 chapter managers. And we certainly strive to

5 do that in a very comprehensive manner, which

6 takes time.

7 So integration is something that

8 we will continually strive to do. And

9 certainly understand their recommendations to

10 do so.

11 We will have a more extensive

12 discussion that Jim will provide about the

13 causal determination for short term ozone

14 exposure and cardiovascular effects. And also

15 about the characterization of potentially at

16 risk populations.

17 We received some very useful

18 comments on how to approach that in a

19 different manner. And we've taken that to

20 heart not only in the ozone ISA, but also in

21 the lead ISA that is also under development at

22 this time.
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1 And then there was quite a bit of

2 discussion at the last meeting about the

3 background ozone concentrations. We have

4 clarified and added to the discussion there,

5 as well as removed part of the assessment, as

6 we discussed at the last meeting, to try to

7 clarify the information regarding background

8 concentrations. At this point, I'd like to

9 turn to Dr. Brown to pick it up from here. 

10 Jim.

11 DR. BROWN: Thank you. I would

12 like to point out for the members of the

13 public that the redline strikeout document

14 that was just mentioned is available on the

15 SAB web site. I have seen it posted there. 

16 I haven't tried to open it, but I have seen it

17 posted there.

18 It's useful for me as well to go

19 through and look at exactly how many changes

20 we've actually made in this document. One of

21 the things that we did in response to the

22 CASAC comments on the second draft ISA was to
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1 more thoroughly review and integrate the

2 evidence across the scientific disciplines and

3 then also with prior reviews.

4 For example, in Chapter 2 there's

5 now an enhanced integration of the health

6 effects across the scientific disciplines and

7 across the health end points. We've also

8 added a new synthesis of the epidemiological

9 evidence on differences across exposure

10 metrics, on risk estimates, regional

11 heterogeneity in the risk estimates, and the

12 concentration response relationship.

13 In Chapter 4, the exposure

14 chapter, we've added much discussion on long

15 term exposure information and the implications

16 of that to epi studies. We've added new

17 figures that were asked for by CASAC, such as

18 the population concentration maps, which were

19 summarized in Chapter 3.

20 We've also added time activity

21 information, which was used and linked into

22 subsequent chapters. Some of that was
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1 specifically asked for by Judy Graham. And

2 that was specifically added.

3 In Chapter 5 there are new tables. 

4 I mean in Chapter 4 there are new tables in

5 Chapter 5. And there are also new tables in

6 Chapter 6 in that regard. So we took all of

7 those comments asking for more detail, very

8 seriously.

9 In Chapters 6 and 7 you'll also

10 see increased discussion of the recent

11 evidence again, and with consideration of the

12 prior findings.

13 And there's information and

14 discussion on the exposure assessment and the

15 exposure air issues, and any of the

16 implications of that related to the epi

17 studies.

18 Now I'd like to move on to the

19 cardiovascular effects causal determination. 

20 And as you know, CASAC recommended that we

21 increase the causal determination for the

22 short term morbidity effects from suggestive
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1 of a causal relationship, to likely to be a

2 causal relationship.

3 We carefully considered the weight

4 of the evidence in support of a causal

5 determination and our framework. And we also

6 included in our discussion the opinions of

7 other EPA scientists within the Office of

8 Research and Development that were actively

9 conducting research.

10 These being epidemiologists, the

11 clinical researchers, as well as some of the

12 toxicologists, in our discussions to get their

13 opinions as we reevaluated the causal

14 determination.

15 After these discussions, and after

16 going back through and adding some additional

17 work into, or additional studies into the ISA

18 we decided to -- well additional old studies

19 that were not included in the second draft.

20 We decided to maintain a

21 suggestive of determination. Although we saw

22 that there was strong evidence
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1 toxicologically, and a small body of recent

2 work as well, we wondered about the

3 translation of that to humans.

4 And some of those end points were

5 reflex responses and oxidated stress and

6 inflammation, as are listed on that slide. 

7 From controlled human exposure studies we had

8 little consistent evidence from a very small

9 number of studies. So that didn't support the

10 causal determination.

11 When we looked at the

12 epidemiological evidence, we did see positive

13 associations with short term exposure

14 information and mortality. But we saw

15 inconsistent associations when we looked at

16 morbidity.

17 And so I have examples of this on

18 the next two slides. There's a lot of

19 information on this slide. I don't really

20 want to go through it for times sake.

21 The black points are for all year. 

22 The red points are for the warm season. And
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1 the cold points are for the cold season. But

2 the studies overall show an inconsistent

3 association between morbidity and ozone

4 exposures, with odds ratios both above and

5 below one.

6 And this data was actually, as it

7 states on the bottom, it was the odds ratios

8 for overall cardiovascular effects, and

9 emergency department and hospital admissions.

10 Moving on to the next slide, we

11 have some more specific diseases. And we

12 presented with the color scheme still the same

13 as on the last slide. And we still see

14 inconsistent findings. And this again led us

15 to maintain the suggestive determination.

16 We welcome CASAC's and the

17 public's views on our rationale and our

18 conclusions related to these causal

19 determinations for short term cardiovascular

20 effects during today's meeting.

21 Next I'd like to move on to

22 another recommendation made by CASAC. And
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1 that was that we include a framework for

2 assessing the sensitivity, or the risk to

3 certain populations from suffering health

4 effects.

5 And so we provide in this ISA, we

6 have a new table now, Table 8.1, that does

7 present a framework. We've broken things into

8 three categories where we have --

9 I mean, I'm sorry, four categories

10 where we have adequate evidence to conclude

11 that a population or life stage is at

12 increased risk. Going all the way down to

13 seeing little to now evidence of an effect.

14 On the next slide, which is also a

15 new table in the ISA, Table 8.5. This just

16 presents the data for where we saw adequate

17 suggestive, inadequate, and evidence of no

18 effect.

19 For those that are only looking at

20 the screen, there's a printout outside that

21 actually better differentiates these

22 designations.
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1 It was for outdoor workers and

2 above on this table that we saw adequate

3 evidence between genetic effects and obesity,

4 that we said there were suggestive effects.

5 And then influenza infection and

6 below that we saw that there was inadequate

7 evidence for effects. Inadequate evidence to

8 suggest that those groups were at potentially

9 increased risk.

10 Now one of the things that we

11 received a number of CASAC comments from, or

12 on, and more public comments on was

13 background.

14 As a quick review, the

15 calculations of background are designed to

16 answer the question of what would be the ozone

17 concentration if there were no manmade or

18 anthropogenic emissions.

19 However, as ozone chemistry is non

20 linear, we can't take that data and then

21 simply determine the anthropogenic component

22 of ozone from simple subtraction of the
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1 observed values from the background values

2 that are calculated.

3 There's a lot of information on

4 this slide that I'm going to go ahead and try

5 to take you through. This was added because

6 CASAC specifically asked us to go ahead and

7 add new information on the Emery et al study,

8 as well as another paper or two that I can't

9 remember.

10 This one we've not only included,

11 but we actually did a comparison of this data,

12 which was at a fine grid, a 12 by 12 kilometer

13 grid, against what was predicted by GEOS-Chem.

14 The paper had taken a 12 kilometer

15 by 12 kilometer grid. They compared it to a

16 200 by 200 course kilometer grid from the

17 GEOS-Chem predictions. We decided to do what

18 we considered a more appropriate analysis.

19 And that was to compare the

20 defined 12 by 12 kilometer grid from the CAMx

21 to GEOS-Chem's finer resolution 50 by 50

22 kilometer grid. I'm going to take you through
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1 what is actually on this slide. This will

2 take me just a minute.

3 First, the top panel and the

4 bottom panel are sites above and below 1.5

5 kilometers respectively. The data are the

6 mean max daily eight hour average

7 concentrations, averaged monthly for 2006.

8 The observed values from CASTNET

9 rule sites are gray, are on the plots in

10 black. And then the gray area around the

11 plots is one standard deviation above and

12 below the observed values.

13 Comparison of the GEOS-Chem and

14 the CAMx models against the observed values

15 are also plotted on this. In green was the

16 GEOS-Chem, and in blue was the CAMx. The

17 dotted lines at the bottom of these figures

18 are the predicted, or estimated rather, North

19 American background values.

20 I'll pause right there for just a

21 second to say that, you won't notice unless

22 you look very carefully. But this figure
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1 differs very slightly from the one that we

2 have in the ISA. And this will be the figure

3 that we use in the final draft.

4 The reason for this difference is

5 because we inadvertently plotted U.S.

6 background on these figures, rather than the

7 North American background that we had intended

8 to plot. And that's corrected on the figures

9 that are provided today.

10 We've also included a new table,

11 Table 3.1, which provides a seasonal summer

12 screen comparisons between the CASTNET sites,

13 which is on the next slide. I didn't say, the

14 bottom line on the last slide is there in the

15 bottom corner.

16 We didn't see that the resolution

17 really provided any benefit to interpreting

18 the results, that increased resolution of

19 CAMx. So moving on to the new table that's

20 included in the ISA. I won't go through the

21 whole thing.

22 But one of the things that we're
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1 adding to the ISA that was not in the draft

2 that you have is the North American background

3 values that are shown in red on this table.

4 On the next slide CASAC also asked

5 us to consider, and we have included

6 comparisons, or a look at the fourth highest

7 daily max eight hour average concentration.

8 Below these data are for 2006. 

9 The upper panel is the baseline case, which

10 includes all the natural and anthropogenic

11 sources around the world.

12 And on the bottom we have the

13 North American background concentrations on

14 the same days as the fourth highest

15 concentrations predicted by the base model. 

16 This is again, a new figure now, Figure 3.16

17 in the ISA.

18 The bottom line is that the

19 background levels are low, especially in the

20 east, which is further illustrated by Figure

21 3.11 in the ISA, where the contribution of

22 background is the lowest also on the highest
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1 ozone days.

2 Beyond the revisions that I just

3 went through, I put up the slide that I'm not

4 going through, just to say that you made a

5 number of other revisions that are mentioned

6 here.

7 This is not an inclusive list. 

8 There were many other revisions made to the

9 ISA for individual comments and in the letter. 

10 So I put up this slide not to override the

11 charge questions that we already have here.

12 But just to provide a general

13 charge to the panel to please look at and

14 consider the adequacy of the revisions that

15 we've made today in your deliberations. And

16 thank you.

17 CHAIR SAMET: John, anything else?

18 DR. VANDENBERG: Just to again, to

19 reiterate. We appreciate the comments and

20 recommendations of CASAC very much. So we're

21 looking forward to your comments on this last,

22 this third version, and the public comments as
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1 well. So thank you.

2 CHAIR SAMET: Okay, good. Thanks. 

3 Let me see if there are any just very broad

4 and general questions or clarifications on the

5 presentation.

6 Obviously we're going to be

7 discussing the details when we go to the

8 revision. So if there's anything general or

9 related to the presentations that were just

10 made. Yes, Dan.

11 DR. JACOB: Yes. I was interested

12 in hearing your summary of the background

13 ozone analysis. One comment about the figure

14 that you just showed from the CAMx results is,

15 you said on the basis that you have very

16 little background concentration in the east.

17 And also that the background

18 contributes little when you have those fourth

19 highest concentrations. Okay, in the east we

20 have low background. That's fine. In the

21 west it's much more nuanced. And I think that

22 the ISA conveys that nuance.
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1 And I wouldn't simply say that the

2 background is low when the ozone is high,

3 certainly in the west. I didn't see this in

4 the ISA. Just want to make sure that doesn't

5 creep into, you know, the text.

6 DR. VANDENBERG: Thank you. I

7 think again, we're just trying to do a

8 shorthand highlighting here. So what's in the

9 ISA is what really counts. But you're right. 

10 But this is new to this version.

11 And I think the point is that

12 we've brought in the most recent modeling. I

13 think it really represents well the state of

14 the science right now.

15 CHAIR SAMET: Okay. Anything

16 else? Fred, I thought I saw you poised.

17 DR. MILLER: I have one quick

18 question. In terms of the North American

19 versus U.S. background, are both of those

20 materials going to be in there?

21 Because when we get into the HREA

22 and the Policy Assessment I have some definite
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1 views about the need for incorporating those

2 into the risk analysis. And so I want to make

3 sure that you're not adding one and deleting

4 the other. That both are going to become

5 incorporated.

6 DR. BROWN: The table that I

7 showed does provide both the U.S. and the

8 North American background. And that will be

9 added toward -- that modified table is what

10 will appear in the final.

11 CHAIR SAMET: Okay. Anyone else? 

12 Great. Thanks. To be continued for sure. So

13 thank you. So with that we'll move on to the

14 public comment period.

15 Each speaker has been allocated

16 five minutes for their presentation. Angela

17 will give you a one minute warning. And at

18 five minutes I ask that you please end your

19 presentation.

20 We will ask for comments or

21 questions after each presentation from the

22 panel members. So let's see if we're ready
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1 for this. Our first speaker is Sonia Sax on

2 behalf of the American Petroleum Institute.

3 DR. SAX: Is this on? Can

4 everyone hear me?

5 CHAIR SAMET: Yes, that's good.

6 DR. SAX: All right. Thank you

7 for the opportunity to speak today on behalf

8 of the American Petroleum Institute. These

9 comments will focus on the plausibility of a

10 causal association between adverse respiratory

11 and cardiovascular effects, and short and long

12 term ozone exposures below the current

13 standard.

14 For short term respiratory

15 effects, results from human controlled

16 exposure studies indicate that effects are

17 neither statistically significant nor adverse

18 at levels below the current standard.

19 Results from animal studies also

20 show mild effects at exposure ranges of 100 to

21 200 ppb, which are also well above the current

22 standard. Recent epidemiology studies of
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1 associations between short-term ambient ozone

2 exposure and respiratory morbidity have

3 reported mixed results across different health

4 endpoints.

5 And I should point out those

6 figures were really informative on the

7 cardiovascular effects. So we encourage EPA

8 to do the same for other health end points.

9 Many of the studies also had

10 numerous limitations and uncertainties that

11 were not fully considered. These include

12 confounding by other pollutants, the use of

13 central monitors, the unreliability of peak

14 expiratory flow rate measurements, and the

15 biological implausibility of lag times for

16 effects on pulmonary function.

17 For example Mortimer et al, 2002,

18 used subject-administered lung function

19 measurements, reported no significant effects

20 for ozone in multi-pollutant models, and

21 reported positive findings only at

22 biologically implausible lag times.
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1 In fact, EPA noted in the 2008

2 nitrogen dioxide ISA that the same study was

3 unreliable because of its use of

4 self-administered data. Yet this is one of

5 the key studies highlighted in the ozone ISA.

6 In addition, many studies confirm

7 that self-administered peak expiratory flow

8 measurements are too unreliable to make

9 definite conclusions on health effects. This

10 is one example of many similar uncertainties

11 and inconsistencies that need to be weighed

12 and considered more fully in causality

13 determinations.

14 Now the cardiovascular effects for

15 short-term ozone exposures are more uncertain. 

16 And EPA has acknowledged this uncertainty and

17 concluded that the evidence is only suggestive

18 of a causal relationship.

19 And we definitely agree that there

20 is a lack of coherence within the science and

21 weak biological plausibility. There is

22 evidence, primarily from animal studies that
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1 show effects. But only at levels well above

2 the current standard.

3 For mortality from acute ozone

4 exposures, EPA has relied exclusively on

5 multi-city epidemiology studies that have

6 reported relatively small, but significant,

7 pooled estimates of all-cause mortality.

8 The findings are difficult to

9 interpret because of the many unresolved and

10 unexplained sources of bias, and the

11 inconsistencies in results across studies,

12 even for those using similar data sets and

13 modeling assumptions.

14 The heterogeneity in the ozone

15 mortality effect estimates across cities

16 remains unexplained. There is also little

17 ozone mortality evidence from animal studies

18 and only inconsistent evidence of

19 pre-morbidity markers of disease. Lastly, the

20 evidence of adverse health effects from

21 long-term exposures to ozone is the weakest.

22 EPA upgraded the morbidity effects
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1 to a likely to be causal relationship based on

2 reported associations of new onset asthma with

3 specific gene variants. These studies are too

4 few for confidence in the findings.

5 The more robust toxicology

6 evidence is still uncertain, also because of

7 issues associated with extrapolating data from

8 compromised animal models to humans, from

9 high-exposures to ambient and because of

10 inconsistencies across studies.

11 Evidence of mortality with long

12 term ozone exposures is really based on a

13 single study. And this is not sufficient

14 evidence, as has been recognized by CASAC

15 members in previous ISA comments.

16 In fact, of the two new studies

17 available since the last ozone review only the

18 Jared, et al 2009 reported weak positive

19 results.

20 Importantly, the larger body of

21 evidence which highlight the lack of

22 consistently positive associations among
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1 several large cohort studies, such as the

2 Harvard Six Cities study, and the American

3 Cancer Society study and others, should be

4 more fully considered by EPA.

5 In conclusion, the overall body of

6 new evidence presented in the third draft does

7 not support adverse health effects at levels

8 below the current standard

9 EPA should reconsider its

10 causality determinations, and more fully

11 explain how the consistency, coherence, and

12 limitations of these new pieces of information

13 were weighed. Thank you.

14 CHAIR SAMET: Okay. Thank you. 

15 And let me ask if there are questions or

16 comments from panel members. Okay. Thank you

17 very much.

18 DR. SAX: Thanks.

19 CHAIR SAMET: We'll move on to our

20 next presenter, Will Morgan, on behalf of the

21 Sierra Club.

22 MR. MORGAN: Thank you for giving
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1 me the opportunity to comment on EPA's third

2 external review draft, Integrated Science

3 Assessment for Ozone and related photochemical

4 oxidants.

5 My name is Will Morgan and I work

6 here in Raleigh for the North Carolina Chapter

7 of the Sierra Club. I'm speaking today on

8 behalf of the National Sierra Club

9 organization, as well as the Clean Air

10 Council.

11 The Sierra Club's mission is to

12 explore, enjoy and protect the wild places of

13 the earth. And educate and enlist humanity to

14 protect and restore the quality of the natural

15 and human environment. We currently have over

16 600,000 members nationwide.

17 The Clean Air Council is a member

18 supported environmental organization dedicated

19 to protecting and defending everyone's right

20 to breathe clean air. This ISA as part of the

21 EPA's consideration of the National Ambient

22 Air Quality Standard for Ozone, last
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1 promulgated in 2008.

2 The 2008 75 parts per billion

3 standard significantly exceeded the 60 to 70

4 part per billion range recommended by this

5 committee. Since 2008 new scientific evidence

6 has bolstered the conclusion of CASAC that

7 there is a need for stronger ozone standard

8 below 60 parts per billion.

9 The EPA has now produced three

10 draft ISAs in the reconsideration process. As

11 recognized by the EPA, and the recently

12 published first draft of the ozone policy

13 assessment, the weight of scientific evidence

14 in this ISA supports revising the current

15 eight hour primary standard, so as to afford

16 greater public health protection.

17 The Sierra Club and the Clean Air

18 Council agree with the EPA and recommend the

19 process move forward with alacrity so that the

20 EPA can produce a new standard protective of

21 human health.

22 The ISA presents comprehensive
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1 evidence that short term ozone exposure has a

2 causal relationship with adverse respiratory

3 effects, and likely causal relationships to

4 total mortality. The draft also finds

5 suggestive causal relationships between short

6 term exposure and cardiovascular and central

7 nervous system effects.

8 The conclusions regarding impacts

9 of short term exposure highlight the need to

10 lower the ozone standard and exposure period. 

11 This draft ISA also clarifies the effects of

12 long term exposure.

13 The Sierra Club and the Clean Air

14 Council agree with the ISA's conclusion that

15 the weight of evidence suggests a causal

16 relationship between long term exposure and

17 cardiovascular effects, reproductive and

18 developmental impacts, central nervous system

19 effects, and total mortality.

20 With regard to populations at

21 increased risk this draft of the ISA

22 considered new studies, along with historical
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1 evidence, and concludes that there is evidence

2 of increased risk for children, people with

3 asthma, older adults, outdoor workers and

4 people with diets low in vitamins E and C.

5 The ISA also found that there is

6 evidence suggesting increased risk based on

7 gender, socioeconomic status, certain genetic

8 factors and obesity.

9 The Sierra Club and the Clean Air

10 Council believe that the weight of evidence

11 also suggest increased risk for people with

12 diabetes and influenza, for which the ISA

13 concludes there currently is inadequate

14 evidence of increased risk.

15 However, promulgation of a lower

16 standard should not be stalled merely to add

17 those populations to the already large

18 percentage of Americans at increased risk from

19 ozone exposure.

20 It's been four years since the EPA

21 failed to heed CASAC's recommendation of 60 to

22 70 parts per billion standard. The 75 part
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1 per billion standard was insufficient

2 according to all scientific evidence available

3 in 2008.

4 Research conducted in the last

5 four years, and summarized in the third draft

6 of the ISA, confirms and strengthens evidence

7 that ozone causes significant health problems

8 and concludes that an extremely large section

9 of the population has an increased risk from

10 ozone exposure, possibly for several factors. 

11 There is no need for further delay.

12 For the foregoing reason CASAC

13 should approve the ISA and recommend the EPA

14 move forward producing a new ozone standard

15 sufficient to protect human health and welfare

16 as required by the Clean Air Act.

17 The Sierra Club and the Clean Air

18 Council request that these comments be made

19 part of the record. Please do not hesitate to

20 contact us if you have any questions about our

21 comments. Thank you.

22 CHAIR SAMET: Okay. Thank you. 
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1 Are there questions, comments? Okay. Thank

2 you very much. We'll move on next to

3 Stephanie Shirley from the Texas Commission on

4 Environmental Quality.

5 DR. SHIRLEY: Good morning. I'm

6 Stephanie Shirley, a toxicologist with the

7 Texas Commission on Environmental Quality. 

8 The TCEQ is charged with protecting our

9 state's human and natural resources consistent

10 with sustainable economic development.

11 I'd like to touch on several

12 issues concerning the ozone ISA on behalf of

13 the TCEQ. First, is the use of observational

14 epidemiology to support the ozone NAAQS. The

15 current proposed standard is based largely on 

16 observational epidemiology studies.

17 However, these studies are

18 exploratory in nature, designed to look for

19 correlations, which are distinct from

20 causation, and are not rigorous enough to

21 utilize as the basis for such important policy

22 decisions.
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1 In requiring national air quality

2 standards for criteria pollutants, the Clean

3 Air Act treats these six pollutants

4 differently than all other pollutants by not

5 allowing cost and technological feasibility to

6 be taken into account. Therefore, the risk

7 management options left to state regulators

8 are severely limited.

9 In our mind that raises the bar

10 for the scientific basis of standards

11 regulating these criteria pollutants. Second

12 is the discrepancy between ambient

13 concentrations of ozone and personal exposures

14 to ozone.

15 It is widely recognized that eight

16 hour ambient ozone concentrations from central

17 monitoring stations do not accurately reflect

18 personal exposure to ozone. Most individuals

19 spend the majority of their time indoors, and

20 indoor concentrations of ozone are

21 dramatically lower than outdoor.

22 Moreover, TCEQ analysis shows that
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1 eight hour ozone concentrations can easily

2 vary 30 percent geospatially within a county. 

3 Therefore, assigning exposure concentrations

4 to a cohort is problematic.

5 Third, the effect sizes reported

6 as relative risks or hazard ratios in the

7 available literature are quite modest and may

8 be indicative of confounding. Indeed, it has

9 been reported that such studies are more prone

10 to residual confounding than previously

11 recognized.

12 Multiple agencies have cautioned

13 against overinterpreting such small relative

14 risks. Fourth, the definition of an adverse

15 effect with regard to exposure to ambient

16 ozone remains ambiguous and subject to

17 interpretation.

18 Clinical studies examining

19 respiratory effects of low concentrations of

20 ozone have shown only slight reversible

21 effects that are largely not clinically

22 significant. For example, the FEV decreases
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1 found in the Adams, et al study are within

2 normal daily variation according to the

3 Medarov, et al 2008 study.

4 Fifth, there is a lack of

5 consistency within and between studies. There

6 appears to be little critical evaluation of

7 the consistency of findings within and among

8 studies, and often positive associations are

9 overemphasized without regard to their

10 statistical or biological significance.

11 The current weight of evidence

12 approach lacks methods for critically

13 evaluating such factors. Finally, it is

14 difficult to discern the effect of ozone on

15 health endpoints given the presence of

16 confounding factors.

17 Few studies fully account for

18 simultaneous exposure to multiple pollutants

19 which obscures the association between health

20 effects and ozone exposure

21 Furthermore, it has been

22 repeatedly demonstrated that these
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1 associations are confounded by temperature,

2 relative humidity and population

3 characteristics such as age, socioeconomic

4 status and exercise.

5 Overall, the TCEQ encourages a

6 more rigorous and transparent weight of

7 evidence approach that devotes more attention

8 to the limitations of the existing studies

9 with respect to consistency, reproducibility,

10 bias, control for confounders, and

11 shortcomings in methodology.

12 Regarding the secondary standards

13 for ozone the TCEQ questions the need for a

14 separate secondary standard that is different

15 in form and level from the primary standard.

16 There is inadequate research and

17 analysis of the comparative protectiveness of

18 a secondary ozone NAAQS in a form different

19 from the form and level of the primary

20 standard to justify its promulgation.

21 Establishing a secondary -- 

22 Excuse me. Establishing a separate form for
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1 the secondary standard would at the very least

2 cause the state to expend resources on

3 analysis, public education, SIP documentation

4 requirements, and computer resources the could

5 be better directed towards attaining the

6 primary ozone standard, which would benefit

7 the health of both the public and the

8 ecosystem.

9 In closing, the TCEQ's expectation

10 is that regulations, especially health based

11 standards, be based on sound science, be

12 justifiable, and realize true public health

13 benefits. Thank you for the opportunity to

14 provide comment and for your attention.

15 CHAIR SAMET: Okay. Thank you. 

16 Comments? I'll just make a brief comment. I

17 found myself a little surprised by the

18 strength of your dismissal of observational

19 epidemiology.

20 And I will just note perhaps you

21 did not mean your comment to sweep so broadly

22 as it sounded. Certainly there's a long
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1 record of advances in public health based on

2 the findings of epidemiological studies.

3 I recognize that we're moving into

4 a zone where there's complicated data and

5 complicated studies to interpret. So perhaps

6 you meant your comments to be more limited in

7 their scope.

8 No need to reply. I just wanted

9 to make sure that that comment was noted. Any

10 other comments? Okay. Thank you. Okay. 

11 Next we'll move to Nicole Downey on behalf of

12 Earth System Sciences.

13 DR. NUGENT: Ms. Downey provided

14 slides right before this session. And they're

15 posted on the CASAC web site. And I sent an

16 email to members of the panel in case you want

17 to have a copy.

18 DR. DOWNEY: Hi CASAC. Thank you

19 for that. Thank you for listening to me

20 today. Sorry. Today I'll be presenting some

21 comments about the third draft ISA for ozone. 

22 If you remember I was here last time.
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1 I think looking at Chapter 3, or

2 Draft 3, versus 2 and 1, vast improvements

3 were made in this draft. I did pick up on a

4 couple of things in EPA's presentation, which

5 I didn't pick up on in the actual document,

6 which first was the replacement of U.S.

7 background with the North American background,

8 which is a significant shift.

9 And I hope that the point that Dr.

10 Miller brought up, where both North American

11 and U.S. will be included in the final draft

12 is very important.

13 Additionally, I think both the

14 recent papers on background by Emery, et al

15 and Zheng, et al show that ozone is not low in

16 high ozone events. Ozone increases in high

17 ozone events in the west in general.

18 But it does not decrease in high

19 ozone events in the east. And I think that's

20 an important point to make. There are some

21 very clear figures in both of those papers

22 that show that. And I can show those to you
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1 if anyone is interested. Or you can just

2 refer back to the literature.

3 So I think, you know, the changes

4 to the chapter were very good. But in terms

5 of integration there were some issues. And I

6 have two very big questions that I'd like to

7 throw out here.

8 The first is, you know, we know

9 what the uncertainties are. We know models

10 aren't good at predicting high ozone events

11 from background. Background is poorly, the

12 background sources are poorly parametized, et

13 cetera.

14 And so how does that uncertainty

15 that we know about propagate through the

16 health and risk assessment? And I don't think

17 anyone's asked that question. And I don't

18 think that that's been made clear.

19 And I also don't feel like there's

20 a very clear description of how this data will

21 be used going forward. And I've spent a

22 couple of years trying to figure this out. So
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1 take it from me. I think we need a bit of a

2 better description of how these data will be

3 used.

4 And then I think going forward,

5 what is the most appropriate floor for

6 estimating health and welfare benefits? Where

7 do you stop adding up the benefits?

8 And I think this is a very

9 important question. And it's central. We've

10 talked about this background thing. And then

11 as you --

12 Over the next couple of days

13 you'll hear about the new HDDM technique. And

14 this is going to be a very central question of

15 what, where do we stop adding up the benefits?

16 And so EPA defines background

17 ozone as a concentration that distinguishes

18 between concentrations that result from

19 precursor emissions that are controllable from

20 those that are not controllable.

21 The Clean Air Act mandates that

22 EPA protects public health with an adequate
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1 margin of public safety. And EPA's task is to

2 establish standards that are neither more nor

3 less stringent than is necessary for these

4 purposes.

5 So the entire risk and exposure

6 and welfare assessments and policy assessments

7 should be formulated to optimize human health,

8 not to maximize control.

9 And I think, in my view, this is

10 where you have to think about stopping your

11 summation of benefit. You have to take into

12 account the benefit to human health that some

13 of these things, that unfortunately produce

14 ozone or ozone precursors provide.

15 And so when we look at this

16 background everything is turned off. We can't

17 grow food. We can't clean or deliver water. 

18 We can't build houses. We don't have doctors. 

19 There's no public health infrastructure. We

20 can all agree that these have significant

21 positive public health benefits.

22 And if you ignore that in this
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1 process there is a significant bias in your

2 overall results. So I've plotted at the

3 bottom here, this is just data from the World

4 Bank, just to show you there's a very strong

5 relationship between GDP and life

6 expectancies.

7 So on the Y axis here you've got

8 life expectancy going from about 45 to 80

9 years, with the first ten or twenty thousand

10 dollars of GDP.

11 And I know GDP is not the same as

12 emissions. But in your mind you can make the

13 argument that there is some base line level of

14 human infrastructure and emissions that

15 actually have a very positive public health

16 benefit.

17 So in conclusion on that, a broad

18 and open discussion is needed to evaluate what

19 the most appropriate floor for calculating

20 benefits and a health and welfare policy

21 assessment is.

22 Finally, we've talked a little bit
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1 about addressing background and

2 implementation. Right now the only avenue

3 legally is the Exceptional Events Rule. And

4 if you propose lower standards you'll run into

5 background more and more.

6 Because I think we all know for

7 ozone in many parts of the country we're

8 getting close to background. And there is no

9 tool to screen for these events. And

10 development of a tool is not trivial.

11 This is not something we can just

12 pull off of someone's research shelf and use. 

13 And recent guidance from EPA states explicitly

14 that background cannot be excluded with the

15 Exceptional Events Rule.

16 So there is a significant legal

17 challenge here for counties, for states, for

18 people who are trying to meet these standards,

19 that there is no legal avenue to exclude

20 background as it's currently formulated. And

21 I think at a standard below 75 this will

22 become a significant issue. Thank you.
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1 CHAIR SAMET: Okay. Thank you. 

2 Questions or comments? Yes.

3 DR. DIEZ-ROUX: I have a quick

4 comment on that interesting GDP figure that

5 you showed. You know, there's quite a bit of

6 debate as to whether that reflects a causal

7 relationship, or whether there are other

8 factors that go with GDP growth that are

9 driving the health improvement.

10 And there's also some evidence

11 showing that actually short term economic

12 growth has adverse health effects. Very

13 interesting data.

14 DR. DOWNEY: Yes, I'm not -- 

15 Okay, I'm not saying we need all GDP. But I

16 think we can all agree that having food,

17 having clean water, having doctors benefits

18 our public health. And that's the level that

19 I'm talking about here.

20 I'm not saying that we need to

21 have 100 percent GDP. I'm using that as a

22 very rough metric to equate this basic level
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1 of modern society that does significantly

2 contribute to the lengthening of life.

3 I mean, it's not a small effect. 

4 We're not talking about a ten percent in

5 decrement in FEV1. This is a doubling of your

6 life expectancy with some basic services.

7 CHAIR SAMET: Fred.

8 DR. MILLER: Are most of your

9 comments -- I think they're interesting and

10 relevant for the HREA and the policy. But I

11 do not see your comments addressing the ISA. 

12 Did you make it clear that you were -- and I

13 don't know, is the public comment period at

14 this point only supposed to be relative to the

15 ISA? Because I don't feel that the kinds of

16 discussions that you're advocating are

17 appropriate for an ISA. Although they are

18 certainly appropriate for the HREA and the

19 policy.

20 CHAIR SAMET: Just to perhaps, I

21 mean, this is the public comment period for

22 the ISA. Obviously we will take your comments
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1 into account as we move across our two and a

2 half days. But as a reminder, I mean, there

3 are separate comment periods for the other

4 documents.

5 DR. DOWNEY: Yes. I guess my

6 thought is the background chapters in the ISA.

7 DR. BRAIN: Yes. I guess the only

8 exception to what you said, Fred, is I think

9 the focus on background is really very

10 important, and deserves perhaps more attention

11 than the ISA.

12 Both in terms of what kind of

13 background, how do we use it, and how do we

14 both take it into account for regulation and

15 especially communicate clearly the role that

16 background plays in our assessment.

17 DR. DOWNEY: And I also see it as

18 sort of a new definition of background. Where

19 you would have this, what you can reasonably

20 control plus a little bit to live. If that

21 makes sense.

22 DR. MILLER: I understand what
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1 you're saying. But I still do not agree that

2 -- and I understand the importance of having

3 more information on the policy relevant

4 background and the North American and that in

5 the ISA.

6 But the interpretation of it, and

7 its implications for the standards and that

8 does not belong in the ISA. And I think that

9 the Agency has done an excellent job expanding

10 their treatment of background levels by the

11 material that they've added.

12 And you brought up a couple of

13 papers that might be, that they should be

14 addressed also. Maybe they're making

15 exceptions in the sense of how important their

16 information might be. But I totally disagree

17 about the role of the ISA in terms of

18 interpreting its implications for policy and

19 stuff like that.

20 CHAIR SAMET: Okay. Any other

21 comments? Dana.

22 DR. JACOB: I don't know. I'm
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1 going to take you, take Fred a little to task

2 here. Because the REAs are using the ISA as

3 a foundation.

4 And some important points made by

5 Nicole, for example, about the fact that the

6 background is not really exotic, but

7 represents low variability floor ozone that

8 needs to be dealt with regarding setting the

9 standard. It's something that is, I think,

10 not dealt with very well in the REA. And the

11 root of that is in the ISA document.

12 CHAIR SAMET: So let me suggest,

13 this is not the right moment to enter into an

14 intra panel debate during the public comment

15 period. But I think we'll return to this

16 topic. I promise, multiple times. So let's,

17 we'll have that discussion for sure. But any

18 other questions for our public commenter? 

19 Okay, good. Thank you.

20 DR. DOWNEY: Thank you.

21 CHAIR SAMET: Next we'll move to

22 Samuel Oltmans.
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1 MR. OLTMANS: Thank you for this

2 opportunity to present some information on

3 background ozone. I'm Sam Oltmans and I am

4 presenting this material as an individual.

5 I want to emphasize the importance

6 of considering observations as well as the

7 models in discussing background ozone. 

8 Although the current ISA expands the

9 discussion of background ozone, it does it

10 primarily in the context of the modeling

11 efforts that have taken place.

12 I want to emphasize the fact that

13 we can learn something about background ozone

14 from the measurements themselves. Now there

15 are a limited number of sites where

16 measurements can be representative of

17 background ozone.

18 One of these sites is Trinidad

19 Head in California, which is a site on the

20 coast of northern California that very

21 regularly sees air coming in off the Pacific

22 Ocean. And, I think, presents an
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1 observational picture of background ozone

2 moving into the continental United States.

3 This site, as I mentioned, is in

4 northern California. It's well exposed to air

5 flowing in, not only occasionally, but very

6 regularly. The current ISA, as all of the

7 other drafts suggests that this site

8 occasionally sees background ozone.

9 I think this is an under

10 representation of the representativeness of

11 this site for background ozone. And there

12 have been a number of studies that have come

13 to this conclusion. So I think we can look at

14 this site and get a feel for what the real

15 world background ozone levels are.

16 This is a summary of some of the

17 data. You can see that in the spring time we

18 have values that frequently occur over 45 to

19 50 ppb. And these are average conditions for

20 spring time ozone.

21 And as you go up a little bit

22 higher in the troposphere, up to one to two
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1 kilometers, you'll see that the air moving

2 inland from California regularly is over 50

3 parts per billion.

4 So if you look at a number of

5 studies that we've done, and a relatively

6 recent one in 2010, you'll see that Trinidad

7 Head not only is representative of ozone

8 coming in from the ocean, it's very

9 representative of other sites where we've done

10 ozone measurements along the Pacific coast.

11 In other words, Trinidad Head

12 isn't just representative of a spot, it's

13 probably representative of air moving on to

14 the west coast of the United States from the

15 Pacific Ocean. In other words, something

16 similar to what's defined as background ozone.

17 Also we see that there are events

18 in a place like Trinidad Head where we get

19 transport from Asia from biomass burning, in

20 which we can get very elevated values, well

21 over 50 parts per billion from these periodic

22 events, such as this biomass burning event
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1 that's illustrated in this particular slide.

2 This is a comparison of some of

3 the observations from the ISA that show the

4 background amount. Although the average from

5 the model looks like it's fairly similar, I

6 would suggest that in the spring time,

7 particularly when we have these episodic

8 events, that the model underestimates the

9 overall concentrations.

10 But I think under represents the

11 background values as well. Recent modeling in

12 which a model that has very well developed

13 stratosphere shows that the background makes

14 a very important contribution even at the very

15 highest ozone levels very near the current

16 eight hour standard.

17 So to summarize, I think we can

18 look at observations from sites like Trinidad

19 Head, and conclude that the models probably

20 underestimate to some extent what background

21 ozone is, and that background levels are

22 relatively high and are impacted by input from
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1 the stratosphere and episodic pollution

2 events, primarily from Asia. Thank you.

3 CHAIR SAMET: Thank you. 

4 Comments, questions?

5 DR. JACOB: Sam, would you argue

6 that the background measured at Trinidad Head

7 is representative of a background that one

8 might expect at inland sites of the U.S.?

9 MR. OLTMANS: Yes, to a certain

10 extent I do. I think from the ozonesonde

11 observations you see that the air entering

12 above the boundary layer, which is what you're

13 going to see at higher elevations inland, is

14 probably representative of background ozone.

15 Now what we measure in the

16 interior is not background ozone. But I do

17 believe that the transport that you're seeing

18 inland from the Pacific Coast is

19 representative of background. And makes an

20 important contribution to this rather high

21 modeled background that we see in the western

22 United States.
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1 DR. NUGENT: Just a process

2 question. I don't believe we received, I

3 personally received a copy of your slides. 

4 And we will need that for the record.

5 I wonder if you could email them

6 to me, and so I can post them on the SAB web

7 site, or provide them to me on a stick at the

8 break.

9 MR. OLTMANS: Certainly I can

10 email those to you, yes.

11 DR. NUGENT: If you could do that

12 today I'd appreciate it.

13 MR. OLTMANS: Okay.

14 DR. NUGENT: Thanks.

15 CHAIR SAMET: Okay. Any other

16 questions? Okay, thank you. Okay, next we'll

17 move to Allen LeFohn.

18 DR. LeFOHN: Good morning. My

19 name is Allen LeFohn. I reside in Montana and

20 performed research for 43 years, published 125

21 papers, and from 1989 to 1999 was executive

22 editor of, one of three executive editors of
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1 "Atmospheric Environment", and am currently an

2 emeritus editor of "The Journal". I'm also

3 responsible for proposing and developing the

4 use of the W126 exposure index.

5 Evidence published in literature

6 indicates that stratosphere is an important

7 contributor to surface background ozone at

8 both high and low elevations.

9 Underestimates in ozone background

10 for models appear to be related to several

11 reasons, including difficulties in

12 characterizing the contribution from the

13 stratosphere.

14 Besides high elevation sites in

15 the intermountain west and west, the low

16 elevation monitoring sites across the entire

17 U.S. experienced some enhanced ozone

18 concentrations, that is, greater and equal to

19 50 parts per billion that are coincident with

20 stratospheric contributions.

21 Officials in Alberta, Canada

22 observe high spring time ozone levels that
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1 they many times attribute to natural

2 phenomena, such as stratospheric ozone. 

3 Consequently they depend upon the one hour

4 average concentration metric of 82 parts per

5 billion instead of the Canada wide standard of

6 eight hour average metric of 65 parts per

7 billion for assessing human health effects.

8 These are the fourth highest eight

9 hour average concentrations for Glacier

10 National Park, Yellowstone, Denali and

11 Trinidad Head. Fifty-five, 65 at Yellowstone. 

12 Denali is 53 and 51 at Trinidad Head. The

13 enhanced hourly average ozone concentrations

14 at Yellowstone National Park are shown here.

15 These are the number of hourly

16 average concentrations greater and equal to

17 50. This is for 2007 to 2011. Note that for

18 April we have at times over 500 hours out of

19 720 hours for the month, across years. Large

20 numbers of hourly average concentrations.

21 This is the LAGRANTO modeling that

22 we've been doing for the last several years,
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1 that looks at forward trajectories of

2 particles from the stratosphere going to

3 specific sites.

4 The frequency of stratospheric

5 hits at Yellowstone National Park are shown

6 for March through June for 2006, 7 and 8. 

7 There are many, many hits during certain times

8 of the year that are occurring at Yellowstone

9 National Park.

10 The stratospherics and effects on

11 implementing the CWS for the Province of

12 Alberta in Alberta continuing the track. The

13 frequency trend and spatial patterns of events

14 with ozone concentrations greater than 82 ppb

15 for a one hour average is important to

16 consider because most cases are associated

17 with local smog production.

18 In contrast, observations above 65

19 parts per billion, eight hour CWS level, occur

20 at both during local smog episodes, and

21 perhaps even more often as a result of high

22 spring time ozone levels that can be heavily
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1 influenced by natural phenomenon, including

2 stratospheric ozone.

3 Consequently, the Provincial

4 Government continues to maintain an hourly

5 objective. Observations above this threshold

6 are less common than observations above the

7 CWS benchmark.

8 This is right out of the Canadian

9 smog science assessment, which George Allen

10 talked about at the last CASAC meeting. And

11 this is from Chapter 7.

12 There's difficulty in estimating

13 background ozone. The ISA points out that

14 currently all chemical transport models, and

15 not just the ones evaluated in ISA, have

16 difficulty in predicting the short term, one

17 hour and eight hour values.

18 The difficulty in replicating

19 these concentrations within reasonable bounds

20 appears to be related to several reasons,

21 including the specific modules used to

22 describe specific processes. For example
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1 stratospheric --

2 DR. NUGENT: Excuse me, Dr.

3 LeFohn. One more minute.

4 DR. LeFOHN: -- exchange. Thank

5 you. Results published in the literature

6 report that the stratosphere is important. 

7 LeFohn, et al investigated the effects of STE

8 events and associated enhancements.

9 And for most of the sites analyzed

10 we reported that the stratosphere

11 contributions were frequent and related to

12 enhanced ozone.

13 Our latest paper, which is now in

14 press, accepted last week, shows that the

15 site's high elevation in intermountain west

16 and west low elevation monitoring sites across

17 the entire U.S. experienced enhanced ozone.

18 These locations of the sites

19 across the United States and the stratospheric

20 influence on daily maximum average

21 concentration enhancements by region of the

22 country.
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1 This is the average number of days

2 per month when STT-S is coincident with ozone

3 enhancements. Thank you. And yes, I will

4 provide copies of the overheads to you

5 immediately.

6 CHAIR SAMET: Thank you. 

7 Questions, comments? Joe.

8 DR. BRAIN: Help me understand how

9 when we move 1000 miles, you know, away from

10 the Pacific Ocean, how do we separate the

11 domestic source or precursors for ozone from

12 this background that you're talking about?

13 For example, I mean, going

14 further, some of the highest ozone levels

15 we've observed were on top of Mount Washington

16 in New Hampshire.

17 And yet I think many people feel

18 that that relates to, you know, sunlight at

19 high altitudes interacting with domestic

20 precursors of ozone. So how do you, you know,

21 how do we interpret these sites once we get to

22 Wyoming and Montana?
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1 DR. LeFOHN: What we've done with

2 the LAGRANTO model, which Dr. Heini Wernli

3 from ETH in Zurich exercises the model. And

4 he's one of the world's greatest experts in

5 this area. He essentially brings particles

6 down, packets down, streamers as they're

7 called, from the stratosphere down to the

8 surface.

9 And there are two things going on

10 here. It's a forward trajectory model. It

11 brings the ozone down. We don't know how much

12 ozone is within the packet as it's coming

13 down.

14 However, we also from a

15 statistical sense relate the enhanced ozone

16 concentrations greater than equal to 50 parts

17 per billion, with these hits. It's not a

18 direct correlation type analysis, but a

19 coincidence matrix.

20 DR. BRAIN: I could certainly see

21 the stratospheric contribution. I guess my,

22 when you're looking at some of these high
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1 altitude sites in Wyoming and Montana, can you

2 identify --

3 DR. LeFOHN: Yes.

4 DR. BRAIN: -- the fraction which

5 is --

6 DR. LeFOHN: Yes.

7 DR. BRAIN: -- attributable to

8 this mechanism, versus the fraction coming

9 from sunlight acting on domestic sources of

10 those known precursors.

11 DR. LeFOHN: It depends on -- 

12 Yes, and it depends on the time of season in

13 terms of the type of signal. For example, in

14 the spring time what we're finding is with the

15 coincidence matrix that we're doing.

16 And we'll look for example at

17 Yellowstone for March. You have the STT-S

18 equals zero. And STT-S greater than one,

19 these are the stratospheric hits occurring or

20 not occurring during particular days. Max

21 ozone less than 50 parts per billion for the

22 day, or max ozone greater than equal to 50.
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1 The on diagonal elements form the

2 relationship between stratospheric ozone

3 coming down and enhancements. The off

4 diagonal elements are the perturbation part

5 that disturbs this arrangement of a

6 relationship. What we call the C element,

7 which is the bottom --

8 For example, you have 2, 6, 2 and

9 21, if you follow me, on March for Yellowstone

10 in the top left. The number 2, which is max

11 ozone greater than equal to 50 but no STT-S --

12 oh, okay. Thank you. Implies that you

13 essentially have enhancement due to something

14 else other than the stratosphere.

15 That C element forms an indicator

16 which we call ABCD. But in this case the C

17 element forms the indicator of interference. 

18 Interference from non STT-S, not stratospheric

19 processes. It could be anthropogenic. It

20 could be lightning. It could be fires. It

21 could be long range transport from Asia.

22 That number pretty much stays low
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1 for Yellowstone throughout -- in this case it

2 was March through June. But we do the entire

3 year.

4 However, at Georgia Station you

5 begin to see anthropogenic perturbation or

6 something else like lighting or wildfires

7 occurring in that particular area. So it's

8 been a long way to respond to your question.

9 But we believe, and our paper does

10 discuss this, which is now in press as of last

11 week, that we are able now to move from beyond

12 the so called pristine cleaner areas of the,

13 some of the areas in the Rocky Mountain area

14 to the more perturbed anthropogenic areas such

15 as Georgia, Houston and some of the other

16 places.

17 So we believe we're able to tease

18 these data, these issues out with the bottom

19 line being that certain times of the year the

20 stratosphere appears to be playing a very

21 important role.

22 Not necessarily just during the
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1 spring time and the high elevation Rocky

2 Mountain, intermountain west, or the western

3 U.S. And there's empirical information that's

4 come from NOAA, from the 2010 analysis on the

5 west coast --

6 CHAIR SAMET: Let me suggest --

7 DR. LeFOHN: -- that has shown

8 that.

9 CHAIR SAMET: -- that we'll need

10 to move on. But I think if you provide your

11 papers, background, along with your

12 presentation materials that would be helpful. 

13 Daniel.

14 DR. JACOB: Yes. I would like to

15 follow up on this attribution of the

16 background to the stratosphere. Because it's

17 not very clear to me.

18 Background ozone increases with

19 attitude in the troposphere for reasons that

20 have nothing to do with the stratosphere. If

21 you put a lid on the tropospheric models you

22 would still have an increase of the background
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1 ozone with altitude that has to do with higher

2 production efficiency of ozone as you go up.

3 And also the vertical profile of

4 chemical loss. And we could elaborate on

5 that. But I think you know about this. But

6 considering that, and also considering the

7 fact that in the lower most stratosphere you

8 have a lot of mixing that takes place. It's

9 when the upper troposphere and lower

10 stratosphere.

11 How can you be confident when you

12 see Lagrangian trajectories going down to your

13 site that you can attribute this elevate of

14 the ozone to the stratosphere? Because it has

15 profound indications.

16 Because when you say, well it's

17 from the stratosphere that implies that it's

18 natural. Well I don't know about that. 

19 Because I'm not convinced that it's produced

20 on the photolysis of molecular oxygen in the

21 stratosphere.

22 It could be stuff that's coming
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1 from lightening in the upper troposphere. Or

2 it could even be from mixing of tropospheric

3 and stratospheric air in the lower most

4 stratosphere. So I'd like to know your --

5 DR. LeFOHN: Sure. I'll be glad

6 to -- I'll try to do it shorter than I did

7 this last one. That's been a very key

8 question that we asked beginning in our paper

9 last year.

10 And if you remember, there's a

11 section there where we talk about that. And

12 it deals with Bithell at the time that we

13 cited. There's now, courtesy of the referee,

14 he or she added a second paper.

15 And the key ingredient of this

16 whole thing is, is the stratospheric ozone

17 somehow encapsulated as it's coming on down? 

18 And so that it's not really washed out, as we

19 discussed in Texas during the workshop on PRB.

20 One side of the picture, people

21 argue is not very important. Because by the

22 time it gets down into the tropospheric area
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1 and such, it's washed out.

2 What it appears to be, what we

3 appear to be seeing is that there are times,

4 not just in the episodic, quick hit, one and

5 a half day transfer down, but in the eight to

6 ten days, that the integrity of the actual

7 packet remains.

8 And that therefore, the ozone that

9 originates somewhere in the stratosphere for

10 whatever source caused that ozone to form, is

11 making it down very close to the surface.

12 And this -- we're seeing the

13 documentation. We're picking it up. The

14 dynamics in terms of how that works and such,

15 not so clear.

16 But the statistical relationships

17 that we're finding tends to add credence to

18 that observation that's reported in the

19 literature. That is, the integrity is there,

20 it's encapsulated, and it is not being washed

21 out a great deal of the time.

22 CHAIR SAMET: Let me suggest that
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1 -- I understand that we have your presentation

2 materials. If you also want to add your now

3 in press paper to the materials you submitted,

4 that might be helpful to do so. I think,

5 Fred.

6 DR. MILLER: I just want to echo

7 what Dr. Brain said. And I have a concern

8 about Yellowstone being very representative,

9 given the Pinedale Valley and the episodes

10 there with the thousands of wells and that.

11 They've been saying that there is

12 no contribution to the Yellowstone levels from

13 anything local. You just fly into Jackson

14 Hole and you drive down, and all of a sudden

15 in the Pinedale Valley you have exceedances of

16 0.12 parts per billion, not 0.075 and so

17 forth.

18 And so to be able to say that we

19 can definitively separate this out, I don't

20 buy the argument. And I think it goes

21 somewhat to the point that Dr. Jacobs was

22 making. And I really don't want you to
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1 comment on it now.

2 CHAIR SAMET: Yes, I think it

3 would helpful again, perhaps to look at some

4 of the details in your analysis.

5 DR. LeFOHN: Let me just say I

6 don't agree.

7 CHAIR SAMET: Okay. Thank you

8 very much. And we'll move on to our next

9 commenter. Christopher Emery, on behalf of

10 Environ International Corporation.

11 MR. EMERY: Thank you for the

12 opportunity to provide my comments. The third

13 draft of the ISA includes some comparisons, as

14 was shown earlier, between GEOS-Chem and CAMx. 

15 And I just had a few comments in this regard

16 today.

17 First of all, we've recently

18 discovered that in the CAMx modeling that we

19 performed last year, that made it into our

20 paper, was actually lacking sort of a snow

21 cover. New simulations with snow cover

22 included are now being undertaken. And are
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1 showing that ozone is actually higher.

2 And the reason for this is because

3 snow cover dramatically reduces the ozone loss

4 to the surface. That means that with higher

5 ozone with snow cover that we're increasing

6 ozone typically about 5 ppb in the western

7 U.S. and throughout the northern tier in the

8 winter and early spring.

9 We don't believe that the omission

10 of snow cover significantly impacts our

11 conclusions or the conclusions reached by EPA

12 in their ISA. Mainly because the assessment

13 included analyses in the more or less late

14 spring through summer.

15 We've also run an EPA CMAQ

16 regional transport model very similar to CAMx

17 for the entire 2006 year, using the same data

18 sets. CMAQ results were very similar to CAMx,

19 except that it generally estimated slightly

20 higher ozone than CAMx, particularly over the

21 high terrain of the west.

22 We believe that this is the result
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1 of one inclusion of snow cover to a more

2 efficient downward boundary layer mixing. 

3 That's a common theme in CMAQ. Also more deep

4 downward transport throughout the entire

5 troposphere due to diffuse vertical invection

6 and cloud mixing.

7 On Page 3-147 the ISA states that

8 neither GEOS-Chem nor CAMx is currently

9 capable of simulating date specific ozone

10 concentrations within reasonable bounds.

11 While I understand the intent of

12 the statement with respect to the modeling

13 results summarized in the ISA, I disagree with

14 the terminology that suggests that the models

15 themselves are incapable of better performance

16 at short time scales.

17 Elsewhere the ISA correctly states

18 that a large proportional model error is

19 related to uncertainty in the inputs. And of

20 course in associated spatial resolution.

21 The input data sets used by GEOS22 Chem and CAMx for these analyses were grossly
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1 representative of 2006 over large spatial and

2 temporal scale. So we need to keep that in

3 mind that these are very general data sets.

4 Because of this I suggest that we

5 revise, or there's a revision of the quoted

6 text to place more emphasis on model results,

7 as opposed to models that are incapable.

8 The model results place more

9 emphasis on uncertainties in the input data

10 sets and resolutions employed. And I think

11 that these revisions should be extended

12 throughout the ISA wherever similar statements

13 are made.

14 I suggest the EPA briefly mention

15 two issues related to GEOS-Chem and CAMx model

16 performance in Section 3.4.3. First, summer

17 ozone over-predictions in the southeast U.S.

18 may be related to two particular factors,

19 among several. A, overestimates of lightening

20 NOx, and assumed vertical profiles. And B,

21 overestimates of biogenic emissions.

22 Second, the ISA mentions that
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1 GEOS-Chem and CAMx performance in California

2 is similar and relatively poor. It's

3 important to note in the ISA that this

4 similarity stems from the fact that both the

5 CAMx runs and GEOS-Chem results that were

6 described on the west coast are dictated by

7 boundary commissions throughout from similar

8 course resolution GEOS-Chem runs.

9 On Page 3-147 the ISA

10 distinguishes between two questions. These

11 were brought up earlier. One, what would

12 ozone concentrations be if there were no

13 anthropogenic sources? And two, how much

14 ozone would be measured in a given time, or

15 simulated in given areas, is due to background

16 contributions?

17 DR. NUGENT: Mr. Emery, one

18 minute.

19 MR. EMERY: Thank you. These are

20 two completely different questions. It's good

21 that the ISA highlights the importance of

22 those two questions, especially in
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1 characterizing the second.

2 We're addressing the second

3 question of modeling work. We're currently

4 undertaking with the same data sets we had

5 published before with snow. And we're

6 conducting again the 2006 CAMx model as

7 described in the ISA.

8 And we're developing with

9 sensitivity analyses and background

10 attribution estimates the full 2006 U.S.

11 anthropogenic missions.

12 Hopefully that can also answer

13 some of the questions to Al about quantifying

14 numbers with the trajectory results. And we

15 can share these results with the EPA once

16 they're available. And that's all I have.

17 CHAIR SAMET: Good. Thank you. 

18 Questions? Okay, good. Thank you very much. 

19 Next we'll move on to Julie Goodman on behalf

20 of the American Forest and Paper Association.

21 DR. GOODMAN: Thank you for the

22 opportunity to speak on behalf of the American
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1 Forest and Paper Association. I will be

2 focusing on two issues in the third draft

3 ozone ISA, EPA's weight-of-evidence approach

4 and its evaluation of controlled human

5 exposure studies.

6 The National Research Council

7 Formaldehyde Review Panel called on EPA to

8 undertake a program to develop a transparent

9 and defensible methodology for

10 weight-of-evidence assessments. The Panel's

11 report contains a roadmap for reform and

12 improvement of the risk assessment process.

13 While the Panel did not specify

14 methods to be adopted, it used the PM ISA

15 approach, which is the same as the ozone

16 approach, as an example of a useful model for

17 providing insights that EPA could use to

18 formulate a more rigorous approach.

19 There are some factors specified

20 in this framework, such as the consideration

21 of Bradford Hill's aspects and weighing of

22 alternative views on controversial issues,
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1 that are crucial for any weight-of-evidence

2 analysis. There are other features, however,

3 that are lacking.

4 In addition, although EPA claims

5 to use this framework in the ozone ISA,

6 certain parts of the framework are not

7 applied.

8 Regarding the issues with the

9 framework itself, there are no clear

10 statements in the ISA indicating how EPA

11 applies the Bradford Hill aspects or how its

12 causality judgments consider all aspects

13 jointly.

14 Just as an example, the ISA states

15 that strength of an association should be

16 considered, but provides no indication of what

17 constitutes a strong association.

18 Most associations in the ozone

19 epidemiology studies are weak in that most are

20 well below 2, and could result from

21 methodological limitations inherent in these

22 studies. Therefore, a definition of strong is
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1 needed for evaluating epidemiology data.

2 EPA should also be more explicit

3 in how it evaluates alternative hypotheses and

4 the criteria it uses to determine which

5 hypothesis is most supported by the data.

6 It is not evident that EPA

7 considers any hypothesis beyond ozone as a

8 causal factor for specific health effects. 

9 Regarding the application of the framework,

10 perhaps the most serious issue is that studies

11 are not always evaluated in a consistent

12 manner. This is particularly the case for

13 epidemiology studies.

14 Sometimes a particular feature

15 that is considered a limitation in one study

16 is not mentioned in the discussion of another. 

17 For example, EPA states that a Girardot 2006

18 study limitation is the outcome measurement,

19 in that lung function measurements were taken

20 by "less well-trained technicians".

21 But EPA does not have a

22 qualification for studies that rely on
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1 self-administered PEF, which has been

2 demonstrated to be a highly unreliable outcome

3 measurement.

4 Studies with the most rigorous

5 methods should be given the greatest weight in

6 an analysis. And it's not clear whether or

7 how individual studies are weighted in the

8 ISA, based on the frameworks criteria.

9 In general, rather than explicitly

10 stating all results, the ISA highlights

11 positive associations and often omits

12 discussions of negative associations, making

13 results seem more consistent than they

14 actually are.

15 These issues are also apparent in

16 Chapter 8 of the third draft ISA, where EPA

17 introduces a new classification framework that

18 it claims is a weight-of-evidence approach to

19 identify and understand what it calls at-risk

20 factors that cause an increased probability of

21 ozone-related health effects.

22 EPA says it uses this framework to
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1 assess the coherence of effects across

2 disciplines and to determine the biological

3 plausibility of these factors.

4 There is no discussion, however,

5 of a review protocol or literature search

6 strategy, and no clear criteria for evaluating

7 individual studies, including how

8 methodological limitations and uncertainties

9 are evaluated, or how results from different

10 lines of evidence should inform the

11 interpretation of each other.

12 It is also not clear that all

13 relevant are discussed, as it appears that

14 positive results are given more weight in the

15 discussion. A true weight-of-evidence

16 evaluation should only emphasize results based

17 on the rigor of the methods used to obtain

18 them, and not based on the results themselves.

19 Finally, I would like to briefly

20 discuss the analysis of controlled exposure

21 studies in the ISA. It does not appear that

22 EPA has made any significant changes, despite
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1 the many scientific arguments put forth in

2 response to the first two drafts.

3 Most importantly, biological

4 evidence supports a threshold mode of action

5 by which ozone exposure over a sufficient

6 duration and concentration overwhelms

7 respiratory system antioxidants, resulting in

8 oxidative damage.

9 This is also supported by the most

10 recent analysis of controlled exposure data by

11 McDonnell et al, which found that threshold

12 models best describe the data, particularly at

13 the lower end of the exposure-response curve,

14 which is most relevant to the NAAQS. EPA

15 needs to acknowledge that the biology and

16 controlled exposure studies clearly indicate

17 a threshold.

18 In conclusion, the third draft ISA

19 does not use an objective and rigorous

20 weight-of-evidence approach to evaluate ozone

21 exposure and health effects data or evaluate

22 the controlled exposure studies in a
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1 scientifically rigorous manner.

2 EPA should follow the NRC Panel's

3 recommendations for best practices in risk

4 assessment to ensure EPA's goal of providing

5 credible causal conclusions about

6 ozone-related health effects in the final ISA. 

7 On behalf of The American Forest and Paper

8 Association, thank you for your consideration

9 of these comments.

10 CHAIR SAMET: Thank you. 

11 Questions or comments? Okay. I'll just make

12 one comment. I mean, this is really a

13 clarification. I was Chair of the NRC

14 Formaldehyde Committee, which was not

15 concerned with full risk assessment, you'll

16 remember. It was concerned with the IRIS

17 process itself.

18 So I think just -- I don't want

19 to overstate what that report was about. it

20 was specifically directed at the IRIS

21 assessment process and not risk assessment in

22 general. So okay. Thank you for your
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1 comments. And let's move on.

2 All right, the last public

3 commenter is Deborah Shprentz on behalf of the

4 American Lung -- I think it should be

5 Association and not Foundation, unless you

6 changed your name.

7 MS. SHPRENTZ: Thank you. The

8 American Lung Association appreciates the

9 effort that has gone into the preparation of

10 this third external review draft. And we

11 believe it provides a sound basis for moving

12 forward with the review of the primary

13 standards for ozone.

14 We would like to offer a few

15 comments on the present draft. First, it

16 would be extremely helpful to include a flow

17 diagram illustrating the cascade of

18 respiratory health effects induced by ozone

19 exposures.

20 Now I know that CASAC suggested

21 removing some other diagrams from the

22 beginning chapters of the last draft ISA. But
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1 we have in mind a different sort of diagram --

2 something similar to that which EPA has used

3 to illustrate the cardiovascular effects of

4 particulate matter.

5 This is important because, as the

6 regulatory process moves forward, health

7 endpoints are too often viewed in isolation. 

8 For instance, the risk assessment reports on

9 lung function decrements as if they are a

10 stand-alone health effect.

11 To the contrary, the declines in

12 FEV1 are just one endpoint that could be

13 readily quantified for purposes of the risk

14 assessment.

15 Ozone not only depresses lung

16 function but also causes inflammation,

17 heightened airway responsiveness, coughing, 

18 wheezing, shortness of breath, increased

19 responsiveness to allergens, and reduced

20 ability to fight off respiratory infections.

21 As well as the more serious

22 effects such as altered development of the
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1 respiratory tract, asthma exacerbations,

2 increased risk of developing asthma and even

3 increased risk of premature death. These

4 respiratory effects may in turn affect the

5 cardiovascular system.

6 When evaluating the results of the

7 risk assessment, it is important to have such

8 a diagram indicating the relationship between

9 lung function, the most readily quantified

10 health effect, and the whole cascade of other

11 harms induced by ozone.

12 In this review, EPA has moved from

13 a discussion of policy relevant background to

14 a newly defined North American Background. 

15 The policy implications of this shift are

16 unclear at this time, but it appears that this

17 change could impact the results of the risk

18 assessment.

19 The lungs, however, do not

20 distinguish the source of the ozone - natural

21 or manmade, homegrown or imported from abroad. 

22 We breathe polluted air and our bodies respond
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1 accordingly.

2 Ozone and other photochemical

3 oxidants are powerful oxidizing agents

4 regardless of the source of precursors. The

5 science assessment can try to characterize a

6 background concentration, but our lungs are

7 taking in the manmade pollution on top of the

8 background ozone and are responding

9 accordingly to the total exposure. The risk

10 assessment and policy assessment must take

11 this into account.

12 With respect to the air quality

13 characterization, 2012 was a hot, hazy summer.

14 Already, we know that there were more ozone

15 violations this year than in any of the four

16 prior years. More areas were affected, there

17 were more violation days, and higher

18 concentrations.

19 Now the ozone season is not over,

20 and we do not yet have quality-controlled data

21 for 2012. Nevertheless, it's important that

22 the ISA and documents that flow from it
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1 acknowledge the fact that the air quality

2 representations based on 2008-2010 may grossly

3 underestimate present-day and possibly future

4 ozone concentrations.

5 In order to protect public health

6 from the well-established harms of ozone at

7 concentrations below the current standards,

8 the American Lung Association urges that this

9 review move forward quickly.

10 Nonetheless, the delay caused by

11 the preparation of a third draft ISA means

12 that the science has advanced since the

13 mid-2011 cutoff for the inclusion of studies.

14 There are several studies of note

15 published since that time that may have

16 bearing on the identification of susceptible

17 populations, the causal findings, or other

18 aspects of the review. And we urge EPA to

19 consider prominent new studies for inclusion

20 in the ISA.

21 We believe this can be

22 accomplished without requiring an additional
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1 CASAC review. And our written comments

2 provide suggestions of about a dozen such

3 studies for EPA's consideration. Thank you.

4 CHAIR SAMET: Okay. Thank you. 

5 Comments or questions? Good. Thank you very

6 much. And thank you to the commenters for

7 their input.

8 Now for those of you who may have

9 studied the agenda closely may have noticed

10 two deficiencies. There's no break, and there

11 are also no assignments. Breaks are

12 determined by the Chair. Oh, what power I

13 have. No break. No.

14 And the other is that we have not

15 designated lead individuals on the preparation

16 of our comments. So I think we can do that as

17 we go through the break.

18 So let me suggest that we take a

19 15 minute break. So I have like about 10:40

20 a.m. So until about five of, and then let's

21 reconvene. Thank you.

22 (Whereupon the above-entitled
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1 matter went off the record at 10:39 a.m and

2 resumed at 10:56 a.m.)

3 CHAIR SAMET: Okay, we're going to

4 move on now to our discussion of the ISA. And

5 we have general comments here from Chris and

6 Joe, Kathy Weathers is not able to be on the

7 phone, she'll be with us tomorrow and we can

8 get her further input. But I think we should

9 go ahead and start with our general discussion

10 of Chapter 1 and Chapter 2. So Chris, let me

11 turn to you.

12 DR. FREY: All right, if I may

13 John, have you assigned the lead?

14 CHAIR SAMET: No I was -- the lead

15 person on this?

16 DR. FREY: Yes.

17 CHAIR SAMET: No, I was going to

18 suggest that I could either have volunteers or

19 conscripts. Are you volunteering?

20 DR. FREY: I'd be happy to

21 volunteer.

22 CHAIR SAMET: Thank you.
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1 DR. FREY: Okay. Well considering

2 this is the third draft ISA I'm going to try

3 to keep my comments brief and I have ten pages

4 of written comments, I'm not going to go over

5 all ten pages. My fist comment is on the

6 preamble, and I guess generally I want to say

7 these four section are, I think, very good and

8 getting better. The preamble, the historical

9 background, the Executive Summary and the

10 Integrative Summary.

11 So I generally want to convey a

12 positive message to EPA that you know, this is

13 definitely an improvement over the second

14 draft and I think these are nice components to

15 have in all ISAs going forward. So, I do have

16 some comments.

17 One is, Figure 1. For awhile I've

18 been struggling with this figure because

19 there's just something to me that's not right

20 about it and I final figured out that it's not

21 depicting the sequence of the ISA, the REA and

22 the policy assessment properly. And so Figure
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1 1 shows the ISA and REA as if they're sort of

2 parallel independent things, and they're not.

3 So in my comments I drew an

4 alternative to figure, I guess it's Figure I

5 on Page LV. Having these Roman numeral pages

6 is a new thing I guess for us. So Figure I

7 would just encourage EPA to take a careful

8 look at that.

9 And what I proposed here I don't

10 expect it to be adopted straight away, but

11 just to show that it would help to more

12 clearly show the sequence of these documents

13 and there's only one CASAC, but CASAC appears

14 twice in the figure. So there's some other

15 things about the figure that I think could be

16 approved.

17 Okay, next comment. This is also

18 in the preamble. There's some discussion of

19 integration and I'm not trying to be

20 factitious, but I think there needs to be a

21 more integrated discussion of integration. 

22 Because integration is sort of hinted at early
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1 on and then they're other things that kind of

2 illuminate that a little bit more.

3 And I think both in this chapter

4 and probably in the Executive Summary and in

5 the Integrative Summary, there should of at

6 least be a paragraph that defines what is

7 meant by integration. I mean, one dimension

8 of it is its integrating evidence regarding

9 causality among epidemiologic toxicology and

10 controlled human exposure studies.

11 But another integration is looking

12 at interactions among the facts. And maybe

13 there's other types of integration, but

14 without a definition or explanation it's a

15 little harder for the reader to know what that

16 means beyond being just a buzz word.

17 Okay. And then in discussing the

18 aspects, and this is moving on to, again Roman

19 numeral pages LXVIII. This is another place

20 to talk about integration, right? So and

21 again not being factitious, but aspects of the

22 aspects that involve integration could be
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1 noted more explicitly. And for example,

2 coherence and analogy are two of the aspects

3 where integration is really a key part of

4 that.

5 On the following page, so this is

6 the page that the middle of the page is

7 determination of causality. And in the

8 paragraph above that it talks about these

9 aspects are taken into account, with the goal

10 of producing an objective appraisal of the

11 evidence. And I guess I paused at the word

12 objective because I'm not sure, I don't know,

13 this is my opinion as one panelist and if

14 everyone disagrees with me that's fine.

15 But it seems to me they're so many

16 subjective elements to interpreting these

17 aspects, that it's probably more valid to say

18 that there's an expert appraisal of the

19 evidence and it can be made transparent as to

20 what that appraisal is. But it's inherently

21 a judgment and so in that in sense I don't

22 know that it's truly objective.
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1 And that's not to say that, that's

2 bad. But you know, my notion of objective is

3 different people using the same methods should

4 come to the same answer. That it would be

5 reproducible and I'm not entirely certain that

6 this is reproducible in that sense.

7 But even if not all scientist or

8 teams of scientists who apply these aspects

9 would arrive at the same answer. I think that

10 it's always possible to document what was done

11 and explain the inferences made, so that at

12 least the reader understands the basis for the

13 finding.

14 And so that would relate to

15 transparency. So maybe this is a little bit

16 more of a philosophical point, but I felt the

17 text was a little to strong there.

18 Lets see, going on to Table II or

19 Table 2 on Page LXXI, so I guess that's 71. 

20 This is the weight of evidence for causal

21 determination and I don't remember now if it

22 was in this panel or another panel, that maybe
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1 it was a public commenter said something

2 about, that this is an unbalanced

3 categorization because there's no category for

4 not causal.

5 And I think there's a good reason

6 why there's not a category for not causal, but

7 I think it might be nice to say something

8 about that. That we can't prove a negative,

9 we can just argue that there's no evidence

10 through repeated experiments of an observed

11 effect.

12 And part of the reason for

13 mentioning is the Table 8.1. It seems like

14 conceptually this is a similar issue, where on

15 the categories for at risk groups there's

16 evidence of no effects. But I wonder if it's

17 better to say no evidence of effects.

18 Which is a different way of, I

19 think it's actually quite a significant

20 difference. I don't thing there's anything

21 wrong with saying we can't prove a negative,

22 but I think it would be helpful to the reader
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1 to say that.

2 Okay, so now I'm going to move

3 onto the Legislative and Historic Background

4 and I think generally this was fine. My main

5 comment was, I think on the historical

6 background it was written very carefully to

7 kind of completely side step a substantive

8 discussion of the interaction between CASAC

9 and EPA on the 2008 standard and the substance

10 of the CASAC advice on reconsideration of the

11 2008 standard.

12 So if someone came to this with no

13 knowledge of that, I don't think they would

14 really get the real story. I'd just make that

15 as an observation. I personally don't have a

16 strong opinion, I think it's all a matter of

17 public record, but in some sense it might be

18 more realistic to at least briefly mention

19 some of the substantive issues that came up.

20 Okay, so now I'll move onto the

21 Executive Summary. I think this is much

22 better written then the second draft. The
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1 second draft was really a difficult thing to

2 read and this is much, much better, so I

3 commend EPA for that.

4 I did as a read, I tried to look

5 at this as a non-expert reader since to me

6 that's the audience for the Executive Summary

7 and I had a lot of trouble digesting the

8 information given on Table 1-1, which is the

9 summary of the causal determinations. And one

10 thing I could say as a reader is, unless you

11 carefully look at the columns it's easy to get

12 confused about.

13 There's a substantive discussion

14 and conclusions from the previous review of

15 kind of the reason for the determination and

16 then the 2012 is a different determination. 

17 And it's kind of easy to think those are

18 contradictory when really it's just a change

19 in evidence over that time period. I don't

20 quite know how to fix that, but it's just

21 something to be aware of readers, I think we

22 get confused by this table.
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1 But I think a maybe more important

2 comment is on clarity of what is being

3 considered in each health outcome. So for

4 respiratory effects, the previous review dealt

5 apparently only with morbidity and then know

6 there's a causal relationship.

7 But in the text later in this

8 chapter, it mentions respiratory mortality. 

9 And so as a reader it's really hard to figure

10 out, is the conclusion from 2012 for short

11 term respiratory effects, inclusive of

12 mortality or only morbidity?

13 And this becomes confusing then in

14 looking at the category for total mortality.

15 Because is the likely to be a causal

16 relationship based on all causes of mortality,

17 including respiratory mortality, in which case

18 likely to be a causal relationship seems too

19 weak.

20 And so it's really a matter of

21 being extremely clear on what these

22 definitions are for each effect category and
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1 whether the things that are not explicitly

2 designated as mortality, do they exclude

3 mortality and is mortality only in this one

4 category?

5 And after rereading the chapter I

6 couldn't really figure out the answer to that. 

7 And I'm sure the answer is later in the

8 document, but from the perspective of the

9 reader of the Executive Summary, I think it's

10 very confusing. So I would strongly urge

11 that, that be clarified.

12 In talking about the climate

13 related facts, this is getting to be on Page

14 112, and I think Sverre and I are the only

15 ones who have hard copies. So anyway, if

16 you're looking that's where it is.

17 It seems to me that the text kind

18 of side stepped a couple of issues that I

19 thought might be important or helpful to the

20 reader to separate. So in looking at the

21 causality and also looking at the aspects, I

22 think one question that could be asked is, is
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1 there a causal relationship between changes

2 and atmospheric ozone concentration and

3 effects on climate?

4 And then the second question would

5 be, can the magnitude of the effects be

6 characterized with confidence? And in the

7 aspects, the answer of no to the second

8 question does not preclude a finding of

9 causality. For example, a small magnitude of

10 an effect estimate made represent a

11 substantial effect in a population.

12 But the way that the text is

13 written, it seems to say that, well we're not

14 really sure what the magnitude of the effect

15 is, so we kind of downgrade the weight of

16 evidence for causality. And to me that was

17 not an argument consistent with the proper

18 application with the aspects. So I think that

19 needs to be done more clearly.

20 So another way of saying, is the

21 discussion says there's uncertainty as to the

22 extend of the effect, but it doesn't clearly
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1 state that there is uncertainty to whether the

2 effect will occur. And I think those are two

3 different questions.

4 Now another factor might be that,

5 well their surface temperature is used as a

6 surrogate for effect, and maybe one could

7 argue that, that's not a sufficient indicator

8 of adverse effect that that is sort of an

9 intermediate indicator. And so that also

10 could be discussed a little bit more.

11 Okay, so now I'm going to move

12 onto Chapter 2, the Integrative Summary. And

13 you know again, I think this is much better

14 then the second draft. I've -- I don't know,

15 maybe I'm the only one on the panel.

16 I've kind of vacillated or not

17 been too happy with Figure 2.1. And in my

18 written comments I was kind of dismissive of

19 it and then, based on some of the public

20 comments, I wonder now if maybe it's a

21 actually a really great figure. Because to me

22 this figure puts more emphases on
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1 stratospheric ozone then it does on

2 tropospheric ozone.

3 And just visually in terms of the

4 amount of detail and a lot of the things that

5 I think we tend to focus on in the REA and so

6 on, is in the lower right part of this figure. 

7 And so I felt like, well maybe the figure

8 doesn't have the right focus, but maybe it

9 does.

10 Maybe that's an open question

11 still as to how import is the stratospheric

12 contribution to background, which I'm not an

13 expert in, so I would defer to the others on

14 the panel on that. So I don't know that this

15 figure to me is very effective for a broad

16 audience.

17 Okay, moving on. I guess just a

18 organizational thing, there was a discussion

19 of modeling a background concentration that

20 refers to the CASTNET Network and then after

21 that is a section on monitoring that explains

22 what CASTNET is. I think just switching those
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1 two would help.

2 Also in the discussion of

3 background concentrations from the modeling,

4 it would be nice to have a summary statement

5 in the text as to what was the finding. And

6 I think the finding is, taking the numbers

7 kind of literally and I know there maybe all

8 kinds of uncertainty associated with them, but

9 the estimated monthly average North American

10 background concentration range is from about

11 24 to 42 ppb based on GEOS-Chem and 27 to 42

12 ppb based on GEOS-Chem/CAMx, depending on the

13 region and season.

14 I think that's a reasonable

15 summary statement. It would be nice to have

16 that. Because the background obviously is

17 going to come up repeatedly in the ISA, the

18 REA, the PA. You know, this is a monthly

19 average and I think one of the challenges is,

20 is how do you interpret that relative to the

21 conditions of the epidemiological data that

22 might be based on daily 8-hour averages and so
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1 on? And I don't know what could be said about

2 that, but this probably -- a paragraph in this

3 summary would be helpful if possible.

4 There is a table, lets see where

5 is it, well no I think it's in the text. 

6 There's some discussion of reported 3-hour

7 averages of ozone in the U.S. that appear to

8 be below the background levels given in Table

9 2.1 and there's no discussion of that.

10 What seems like a contradiction

11 and I think some of it has to do with what

12 statistics were chosen. Some of them were

13 based on median, some based on means and that

14 might explain why the numbers, you know, seem

15 to, you have some numbers that are below what

16 background and they probably shouldn't be. So

17 that needs to be addressed.

18 I think a comment that I made,

19 this was related to bias and the concentration

20 response function, and I believe this is

21 discussed, I put the wrong page number. I

22 think it's on Page 215. And actually one of
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1 the public commenters alluded to this issue.

2 That you know, we know that

3 ambient concentration is a surrogate for

4 personally exposure. For ozone, personal

5 exposures are probably quite a bit lower then

6 ambient concentration. So we know that the

7 concentration response ratio is different then

8 an exposure response ratio.

9 But I think the text could be more

10 clear in saying what we do know from the

11 relation between concentration and response.

12 And that ratios based on looking at, essential

13 co-variation and health effects, with regard

14 to ambient.

15 Concentrations and sort of an

16 underlying assumption is that, well as long as

17 the ratio of exposure to concentration is

18 relatively constant over time, then we can see

19 that signal, even if it's biased. And as long

20 as we consistently apply concentration, then

21 the overall effect estimates and a risk

22 assessment would not be bias. So I don't
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1 know, it just seems like there could be a

2 little more discussion and context there.

3 I've already alluded to some

4 confusion to the reader about respiratory

5 mortality and whether that's part of

6 respiratory effect or total mortality or both. 

7 And that needs to be clarified.

8 On Page 233 there's some

9 discussion of different metrics for exposure. 

10 And these have to do with different averaging

11 times for short term exposures. And I think

12 this comes up also in the REA, right?

13 So it would be nice if there was

14 some analysis of the co-variation between

15 those. I mean are they essentially, you know,

16 highly correlated so that they're giving us

17 the same signal over time, even if the

18 magnitude is a little different. I think that

19 would be helpful.

20 Okay, let's see, this is getting

21 on to Page 235. I think there's some

22 discussion of lag structure and epidemiologic
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1 studies and some other issues with epi

2 studies. I think one thing that needs to be

3 handled better here and also when we get to

4 the REA and that policy assessment, is the

5 implications of background for the range of

6 variability and concentrations that are

7 observable in the epi studies.

8 And this also relates later when

9 we talk about the LML in the REA. I think the

10 ISA can at least be more clear perhaps on you

11 know, we have an estimate of monthly average

12 North America background, does that tell us

13 anything about the range of variability we

14 would expect to see in EPI studies?

15 And then of course, we know what

16 we've observed in epi studies, but those are

17 often for different averaging times. Some

18 discussion of that I think is really needed to

19 reconcile those.

20 And then I think one last comment.

21 On Page 237, there's a nice discussion of

22 regional heterogeneity, the risk estimates. 
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1 And this touches on a comment early about, you

2 know, why is it that the concentration

3 response relationships are not the same in

4 different cities? And I mean there's a pretty

5 good discussion of that here and later in the

6 ISA.

7 So I think you know, EPA has

8 addressed that concern. But just reading this

9 from the prospective of someone living now,

10 after the 2008 economic downturn and reading

11 that, you know, unemployment is a factor that

12 leads to kind of increase risk.

13 And I think that doesn't mean

14 literally, that if you lost your job yesterday

15 you're suddenly at increased health risk for

16 exposure to ozone. That unemployment is

17 really a, it's a surrogate of other things too

18 and maybe a little discussion of that would be

19 nice. That's it.

20 CHAIR SAMET: Okay, thank you

21 Chris and as always your comments were

22 thorough. Let me just remind everyone however
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1 that we need to cover the whole ISA between

2 now and lunch. So that might be a hint to be

3 brief in your comments. No criticism

4 intended. But hunger my loom around 1:00. 

5 Joe?

6 DR. BRAIN: My instructions are

7 clear. And Chris has done a good job, so I'll

8 just make a few comments. First the Preamble,

9 again I found it very useful and really sought

10 as a model for what every document should

11 begin with.

12 And in that context, I saw Figures

13 1, 2 and 3, which deal with the process as you

14 know, kind of boiler plate. Which continue to

15 be refine but really might be replicated for

16 any pollutant. For example, Figure 2 has

17 these concentric ovals showing how the vast

18 literature base is now narrowed down to ones

19 that are particularly important.

20 Also in the Preamble is the

21 framework for causal determination. And

22 Tables 1 and 2 are really important. And I
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1 though they were really important, in fact it

2 seems to me that, that philosophy and all the

3 discussion of that, it would be nice if that

4 really appeared somewhere as an independent

5 entente.

6 So I suppose that goes beyond our

7 responsibility. But I thought that would be

8 great if there was you know, a small

9 subcommittee that really looked at that and

10 tried to publish this framework for causal

11 determination.

12 And these different definitions of

13 different levels of causality, it would be

14 nice if that document appeared somewhere, was

15 peer reviewed and could refer to in future

16 documents. But I thought this was a useful

17 introduction.

18 Let me say just a little bit about

19 the Executive Summary. It's 14 pages long, I

20 think that's a good length. We would hope

21 that newspaper reporters, staffers and

22 graduate students -- lots of people would read
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1 this.

2 I found rubrics useful. I

3 especially liked the fact that statements

4 about causation where bolded at the end of

5 every paragraph. So I thought you know, one

6 could even quickly look throughout at those

7 bolded sentences and get a good sense of many

8 of the important conclusions.

9 My probably most important

10 criticism is you know, if I were a newspaper

11 reporter looking at this as a guide to what I

12 should say, there really is almost no

13 information about ozone concentration. The

14 verify first paragraph says what the current

15 standard is, but then all these statements

16 about you know, that mortality is likely to be

17 a causal relationship between short term

18 exposures to ozone and totally mortality.

19 Well at what level? And it seems

20 to me that maybe hard to add that information,

21 but perhaps one could link it. Provide some

22 links that would take you to other places. So
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1 I saw really a paucity of information about

2 relevant ozone levels. When did these

3 effects, when are they casual at what levels

4 of ozone?

5 Then let me just say a few

6 comments about the Integrative Summary. It's

7 longer, 54 pages, and I think you know, does

8 a good job. Again the rubrics are useful

9 here. There are links throughout, so anytime

10 you want more information you can click on one

11 of the blue parenthetical phrases and it takes

12 you to where you want to go.

13 That also reminds me of another

14 suggestion. I think you know, Chris and I

15 looked at sort of the overall format in thrust

16 of these. But I think it's very important

17 that all the subsequent reviewers look at how

18 their chapter was summarized, both in the

19 Executive Summary and the Integrative Summary.

20 Because I confess. I certainly

21 you know, when you talked about welfare

22 effects a lot of things I wasn't similar with,
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1 I could evaluate you know and had comments

2 about clear communication and whether it fit

3 with my understanding. But there was

4 certainly levels of detail, certainly here,

5 that I think everybody responsible for the

6 corresponding chapter should have a look at.

7 And then finally both in the

8 Executive Summary and the Integrative Summary,

9 just to emphasize discussion that's already

10 gone on, the whole issue of background looms

11 very large. And I'm not sure, I mean it's

12 mentioned in all of these.

13 In the Executive Summary you know

14 for example, on Page 2 it talks about ambient

15 ozone concentrations and there's a paragraph

16 about background. But you know, and I guess

17 I'm now gradually understanding that PRB is

18 gone, its disappeared.

19 I suppose it still exists out

20 there as a general concept that could surface

21 anywhere, and it's now been replaced by the

22 North American background ozone concentration. 
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1 But I think you know, for everyone to sort of

2 understand that and especially, although it

3 mentions it, it doesn't really say how it's

4 used.

5 Either in terms of appropriate

6 standards or in terms of interpreting clinical

7 studies, as to what's the relevant background. 

8 So I really think as our discussion has

9 already illustrated, that this whole document,

10 but also in the Executive Summary and the

11 Integrative Summary. We need to have a clear

12 understanding of what is the background and

13 how does it vary in time and space as it

14 clearly does.

15 And then especially how it's used

16 in the regulation process and in the

17 interpretation. So I think those are my high

18 level comments.

19 CHAIR SAMET: Okay, thanks, Joe. 

20 I going to take one comment. I think Chris's

21 description of Figure 1 and an attempt to draw

22 it is important, actually I don't think Chris
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1 has it right yet either and I'm not sure we

2 know how to draw Figure 1.

3 We see reading the documents, in

4 fact an arrow that seems to go to the policy

5 analysis back to the REA. And the materials

6 we've been given and I think this is something

7 that as we have discussions over the next two

8 and a half days, I'd actually like to make

9 certain that we understand what is the figure.

10 Because I don't think it's the

11 existing figure or Chris's attempt to clarify. 

12 I think further clarification of the whole

13 broad struck to the process is needed.

14 I would also urge you on this

15 question, highlighted by Chris of the

16 reconsideration and what went on over the,

17 look at that, that the story is described in

18 three different ways in the different

19 documents. And that you need to make certain

20 that those descriptions are appropriately

21 complete and consistent.

22 And then to Joe's point, and I
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1 think some of Chris's comments highlight this.

2 There's the problem when you do the summary of

3 capturing some very complicated material from

4 each of the chapters, and I think you know, we

5 all need to take, as Joe recommended, take a

6 close look at what is said. Because I think

7 in summarizing sometimes, perhaps to much gets

8 chopped away.

9 So I think the different groups

10 need to go back and look at that. I do want

11 you all to just keep in mind as we go through

12 and we'll probably come back to discuss this,

13 this sort of flow from document to document. 

14 Fred?

15 DR. MILLER: To that vein, I feel

16 that the Executive Summary is missing one key

17 thing and it's also not in Chapter 9. That

18 has to do with the evaluation of the welfare

19 data of the alternative form of the standard,

20 back to the W126 as we had recommended and

21 wasn't followed through on. But there's no

22 mention here of alternative forms for the
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1 welfare.

2 And clearly the science in the ISA

3 indicates that, that should in there. And

4 it's not in the current Executive Summary nor

5 in Chapter 9. So I feel that's one area that

6 has to be cleaned up.

7 And the other comment relative to

8 the Integrative Summary is, the McDonnell

9 paper is going to change the aspects of non10 zero threshold and what's in Chapter 6. And

11 what's going to have to be modified here in

12 the Executive Summary.

13 CHAIR SAMET: Okay, others? Okay,

14 all right good. Then we'll make a bold move

15 to Chapter 3. And Daniel?

16 DR. JACOB: All right, thanks,

17 John. Chapter 3, in my opinion, has

18 considerable improved over the second draft

19 ISA. And I had no general issues of content,

20 in particular in it's fundamental mission to

21 deliver DES background ozone estimates of REA

22 and also discussion of patterns of ozone over
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1 the United States.

2 I have a number of minor technical

3 comments. And I'm not going to bore you

4 those, they're in my individual comments. 

5 What I would like to do in my time here, is to

6 go over two fundamental issues, conceptual

7 issues that I think could be clarified a

8 little better in this chapter and/or a source

9 of significant confusion, as we have seen in

10 this mornings discussion.

11 First point I would like to go

12 over is Figure 3.1, which is the same as the

13 Figure in Chapter 2 that Chris commented on. 

14 And I think that our last panel meeting we

15 though that this figure was to complicated and

16 really did not convey the important process,

17 driving the chemistry of ozone as it's

18 relevant for air quality.

19 In fact, the title of this figure

20 is The Process Controlling Stratospheric and

21 Tropospheric Ozone. I think that, not only is

22 this figure too complicated, not only does it
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1 not enough convey what we're after, in terms

2 of relating emissions and processes to levels

3 of ozone, it's also misleading.

4 Because it provides to much focus

5 on the stratosphere. And maybe it's a

6 reflection of the confusion this morning that

7 Chris said, well maybe that's right because

8 after all, even stratosphere is very

9 important.

10 Well I would like to challenge

11 this. Because I think that the level of

12 confusion that we've had this morning, is not

13 really reflective of the level of

14 understanding, that we have in the atmospheric

15 chemistry community.

16 And so moving away from this

17 figure, I would say that this figure places to

18 much emphasize on stratospheric ozone and also

19 it's a bit misleading. Because when you look

20 at the direction of the arrows, you feel like

21 the stratosphere is a fountain delivering

22 ozone to the surface. And I don't think we
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1 want to convey that, because I don't think

2 that's correct.

3 All right, so let me move on now

4 to the more conceptual issue the stratospheric

5 influence and surface ozone. This is

6 something that we've heard a lot and, okay, I

7 think that the Chapter 3 could do a better job

8 at giving a general explanation of why

9 background ozone increases with altitude.

10 Why you have elevated ozone at Mt.

11 Washington observatory or Yellowstone,

12 compared to levels at the concentration sea

13 level. And this has nothing to do with the

14 stratosphere. It has to do with the fact that

15 ozone production in the upper troposphere is

16 extremely efficient, which has to do with NO2

17 partitioning.

18 It also has to do with the fact

19 that chemical loss of ozone driven by water

20 vapor, is most important in the lower

21 troposphere. And then you also have the

22 deposition, sink under the surface.
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1 If you construct a global model

2 with a lid of the tropopause, you will find

3 ozone increasing with altitude, very much in

4 the same way as the observations. This is

5 something that we understand very well.

6 Basically the vertical profile of

7 ozone stretching from the surface to match the

8 upper troposphere is only marginally dependant

9 on transport from the stratosphere. So then

10 this leads to, why do we talk so much about

11 the stratosphere?

12 Well the stratosphere is a big

13 reservoir of ozone. And if you sit at a

14 surface site and you watch ozone coming down,

15 you say whoa. When I see air parcels sinking

16 from high altitude, ozone is high. Oh, must

17 be coming from the stratosphere. Well non the

18 silly still, it could be coming from the

19 middle in upper troposphere and most generally

20 that's what it does.

21 But sometimes you will see, when

22 you do the Lagrangian analysis, the air
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1 parcels crossing the tropopause. And you say,

2 oh those air parcels actually came from above

3 the tropopause. This requires some faith in

4 your Lagrangian model analysis because we

5 don't actually understand very well the

6 process that transport ozone across a

7 tropopause.

8 We understand quite well the

9 global flux of ozone from the stratosphere to

10 the troposphere, this is actually very well

11 constrained. But the process, the detail of

12 the process are fair less well understood.

13 So then there's a question also

14 of, if you do see an air parcel coming down

15 from the stratosphere to the surface, was that

16 ozone really made in the stratosphere? Well

17 that's not very clear, because again you have

18 mixing taking place across the tropopause.

19 And when you talk about this ozone

20 being of stratospheric origin, it's a little

21 bit loaded. Because you're saying then that

22 this is ozone is of course natural. But it's
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1 not necessarily natural, for every reason that

2 I've gone over.

3 And there has been some recent

4 studies on stratosphere contributions to ozone

5 and the surface, that are beautifully

6 referenced in the ISA. That suggest that

7 ozone contributions from the stratosphere to

8 the surface are higher then previously

9 thought.

10 But this has to do with the

11 definition of stratospheric ozone and in

12 particular the work of Arlene Fiore, who I

13 respect a lot, is a former student of mine, so

14 I should and I do. But the way that she

15 defines stratospheric ozone, is ozone that at

16 some point in it's lifetime has gone across a

17 surface where ozone is over 90 parts per

18 billion.

19 That's not only as a pretty lose

20 definition of the stratosphere, but it doesn't

21 recognize the fact that you can have ozone

22 produced in the troposphere, going a little
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1 bit above the tropopause and all of a sudden

2 being re-labeled as natural stratospheric

3 ozone. That's not right.

4 I mean, that's not right in terms

5 of understanding the sources of ozone. It's

6 perfectly fine if you're trying to explain

7 elevated ozone at the surface. But you have

8 to be careful about interpreting elevated

9 ozone at the surface in terms of the

10 stratosphere origin, either in terms of the

11 production of ozone or in terms of transport.

12 Anyway, that's my soapbox about

13 judgment from the stratosphere. But I would

14 say that if you talk to many global activist,

15 most of the global activist are coming from

16 the committee. The overwhelming majority of

17 the global activist or committee, they would

18 say exactly what I say.

19 All right, so I think that the

20 level of confusion is not reflective of the

21 knowledge in the global atmosphere chemistry

22 committee. I spent a lot of time on this so
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1 I'm not going to spend much time on anything

2 else.

3 The only other point that I wanted

4 to make in Chapter 3 of the ISA, conceptual

5 point. Is the question about, how do you

6 define background? And so we define

7 background by saying well, you know that's

8 the levels of ozone that we would have if we

9 shutoff emissions from the U.S. or from North

10 America or from the world, anthropogenic

11 emissions.

12 Okay, but it says, well if there's

13 a different way, which is to say, can we try

14 to describe the ozone molecules in the

15 present day situation to a background source. 

16 So for example, if you're at Yellowstone or

17 whatever other site, you're measuring a

18 certain level of ozone. How many of these

19 ozone molecules came from sources outside of

20 North America?

21 And I think the problem is, is you

22 absolutely cannot do this. Because it's a
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1 highly non-linear problem. And I'm not using

2 non-linear here lightly, it's a totally non3 linear problem.

4 So the problem is very much ill

5 posed. In other words, you will never be

6 able to quantify the contribution of the

7 background to present day ozone levels if the

8 word contribution is not good. And it's used

9 in Chapter 3.

10 I don't mind it used to much

11 because it's actually simple to understand.

12 But what I don't like is when Chapter 3 goes

13 into a digression about different ways of

14 defining the background and could we try to

15 define a true contribution by labeling ozone

16 molecules. I just don't think that you could

17 do this.

18 And I don't think this discussion

19 is useful. It just reads confusion and I

20 would just delete it. Thank you.

21 CHAIR SAMET: Okay, thank you. 

22 George?
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1 MR. ALLEN: Thanks, just some

2 brief comments. First of all I thank you to

3 EPA staff, the mark up version made the

4 review of this third draft a lot more

5 efficient and it's greatly appreciated. The

6 changes, at least to Chapter 3, are very

7 responsive to the panel comments from the

8 second draft and substantially improved this

9 chapter of the ISA over the second draft. 

10 And I wanted to acknowledge the staff efforts

11 for this revision.

12 The addition of the metrics for

13 the background estimates relevant to the

14 fourth highest max daily 8-hour average of

15 ozone concentrations, putting it in that

16 context are very useful. Just a couple of

17 minor comments in addition to what has

18 already been said.

19 On Page 334, there's a reference

20 to a Thompson paper estimating that 20/25

21 percent of the tropospheric ozone over

22 Northeastern North American, during the
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1 summer of 2004, was of stratospheric origin. 

2 This was during the ICARTT campaign over the

3 Gulf of Maine.

4 That's always bothered me, I've

5 commented on this before. It could be on the

6 high side because on the surface, at least

7 2004 was pretty clean, ozone summary in the

8 Northeast. One of the cleanest for the

9 entire decade and I give a reference for that

10 in my comment, which would bias those

11 observations. And I just thought that

12 perhaps that should be some kind of note

13 there. Just to put that in context.

14 And later on we take about

15 wildfires, a source of ozone. I'm still a

16 little concern that there's a potential

17 confounder that whenever you measure ozone

18 with woodsmoke, there is a potential

19 elemental mercury in woodsmoke. Certainly in

20 the Eastern U.S., because there's mercury in

21 wood.

22 Elemental mercury is a strong
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1 interference for the UV Ozone method. I

2 don't if that explains any or some of what we

3 observe, but it's certainly a potential

4 confounder.

5 Other then that I just think you

6 know, overall the chapters dramatically

7 improved over the second draft.

8 CHAIR SAMET: Thank you, Ted?

9 DR. RUSSELL: My first comment, I

10 really liked getting back to Chapter 2. I

11 really liked it, I know use it in my class

12 and think the students like. So kudos there.

13 So I don't have much to add. One

14 thing I'd like to see more of is looking at

15 multi year trends, not just of the higher

16 values, but also looking throughout the

17 spectrum of ozone levels.

18 Just because I think you do have

19 enough evidence there to see that you're not

20 getting the same response at the lower

21 concentrations. And I think that has an

22 important implication in terms of how the
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1 standard might be formed.

2 If you were to change the form of

3 the standard and also in terms of how ozone

4 is responding to controls. And that can also

5 inform how, you know, I think you might

6 approach this issue in the REA.

7 My next comment really has to do

8 with looking at the rollback model. Now if

9 your going to get away from the rollback

10 model in the REA, you don't have to present

11 it and describe it or critic it some much in

12 the ISA. But I think that is a science

13 issue.

14 Now that you're looking to go

15 towards a different method, towards HDDM

16 based method, then I think you have to

17 actually provide more of an analysis of that

18 approach in the ISA. Currently there's like

19 a paragraph that mentions DDM.

20 So again, I think these are

21 scientific aspects that have to be addressed

22 further in the ISA. Thank you much.
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1 CHAIR SAMET: Thanks, Ted. David?

2 DR. CHOCK: I only have two

3 comments and they are mostly related to the

4 climate change issue. I like the ISA Chapter

5 3 very much, they did a great job.

6 The ISA highlights a paper by

7 Leibensperger and it indicates that the

8 downward trend of the frequency of occurrence

9 of the mid-latitude cyclones, can impact the

10 number of high ozone concentration days. But

11 yet the model makes an assumption, primarily

12 a linear assumption. Linear trend of the

13 ozone pre-cursor emission reduction and the

14 downward trend of the frequency of a currency

15 of the mid-latitude cyclone, could both

16 linearly and adequately impact the trend of

17 the number of high ozone days.

18 So this is a linear assumption,

19 but as we all know that the ozone system is

20 extremely non-linear and maybe we are to look

21 into this assumption more closely. And

22 there's a recent paper by Turner, which
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1 actual looks into this issue using a model

2 from the GEO Physical Fleet Dynamics Cm-3

3 Model.

4 And they actually show that by

5 holding the emission ozone, because emission

6 constant. The impact of the trend of the

7 mid-cyclone occurrences, actually placed a

8 relatively minor role in increasing the

9 number of high ozone days.

10 So the paper was submitted in

11 June, and I don't know whether it's been

12 accepted or not. If it has I would recommend

13 that the EPA incorporates this paper into the

14 ISA.

15 The second point is a paper that

16 was written in 2007, published in 2007. That

17 also shows the reduction in the mid-cyclone

18 frequency and also the time of onset of the

19 mid-latitude cyclone frequency. And both are

20 associated with an increase in the areas of

21 wildfires.

22 So this has something to do with
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1 the background concentration, contribution as

2 well. And this was not included in the ISA,

3 I hope that EPA will take this into

4 consideration. And I do have some other

5 minor comments, but I don't want to waste my

6 time on it.

7 CHAIR SAMET: Okay, thank you. I

8 think there were two broad important points

9 that Daniel raised in his presentation, that

10 I just want to make sure that there's

11 sufficient discussion and agreement. I mean

12 one was this discussion of your views of the

13 stratospheric contribution and the role and

14 the figure in the general discussion.

15 The other was this question of

16 background and understanding it and as you

17 put it, an ill-posed question or however. 

18 And particularly I was thinking that you

19 might be the right person to take these

20 points and those of others and be the lead on

21 this section.

22 But I wonder if we don't need a
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1 little bit more discussion of those broad

2 points, no one else commented on them. So

3 why don't we maybe start there in our

4 discussions. Joe?

5 DR. BRAIN: Yes I have a question

6 about the background, and in fact Dan, I was

7 a little confused. I thought I heard you say

8 that the background excludes all ozone as a

9 result of human activity, anthropogenic

10 sources as we understand it?

11 But I recall previous

12 conversations where the background was

13 included, anthropogenic sources from outside

14 the United States. So which is it? I seem

15 to remember both of those, that if ozone

16 precursors came from China or deliberate

17 setting afar, that was not included. So what

18 is the correct definition of background? 

19 DR. JACOB: Well, I think that the

20 EPA has moved into considering three

21 alternative definitions of background,

22 carrying them through the REA. One is the
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1 U.S. background, U.S. anthropogenic

2 emissions.

3 Second one is the North American

4 background, which was previously called PRB,

5 which is North American anthropogenic

6 emissions, including Canada and Mexico.

7 And third is natural background,

8 in which anthropogenic emissions are zeroed

9 worldwide and methane is brought down to pre10 industrial levels. So three different

11 definitions of that.

12 DR. BRAIN: So can you tell us

13 what the one that you're using?

14 DR. VANDENBERG: That's correct.

15 DR. BRAIN: All three?

16 DR. JACOB: All three, yes.

17 DR. BRAIN: That sounds confusing.

18 DR. CHOCK: I think for the REA

19 they're talking about the --

20 DR. BRAIN: So we need to

21 carefully delineate these three different

22 kinds of background?
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1 DR. VANDENBERG: It's just as Dr.

2 Jacob described, is that we're looking at, in

3 the modeling exercise as, in a sense, turning

4 off certain contributing areas of the world. 

5 U.S., North America and the natural. So it's

6 more informed in that fashion, but to provide

7 more information.

8 DR. BRAIN: But then in terms of

9 really seeing how much room there is for

10 improvement, don't you need to pick one of

11 those? Or emphasize one?

12 DR. JACOB: Well, then it becomes

13 a policy matter. So you can say, well U.S.

14 background is what you can control, simply

15 with domestic policy measures. But if you

16 find that you have significant health and

17 welfare issues with ozone at levels that are

18 between that and the natural background, and

19 that may push you to, I don't know, looking

20 into international regulations.

21 It's something that the Europeans

22 had to deal with for some time. And we may
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1 have to head down that road in the future.

2 CHAIR SAMET: So this is really a

3 discussion we'll come back to in the REA

4 policy analysis.

5 DR. BRAIN: But I think right now

6 we don't have a clear explication anywhere. 

7 I mean, I found what you said understandable

8 and makes sense, but I don't see it in the

9 Executive Summary or the Integrative Summary. 

10 That these three definitions --

11 DR. VANDENBERG: Well, again, I

12 think that perhaps part of this conversation

13 will carry over to the REA.

14 CHAIR SAMET: Yes, I think this is

15 a discussion that will be extended. Howard?

16 DR. NEUFELD: Just as a matter of

17 proceeding. Can I ask a question of Daniel 

18 regarding Chapter 3?

19 CHAIR SAMET: Sure.

20 DR. NEUFELD: There's a section

21 here which goes into hourly variations, Page

22 134. And from a plant point of view, there's
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1 this pattern, at least as I've seen it, where

2 you go from where it's low in the morning,

3 high in the afternoon at low elevations. And

4 as you go up in elevations you start to get

5 those flatter profiles.

6 I was wondering if you could

7 comment on that general pattern and do you

8 think that this chapter emphasizes those

9 differences enough? Because from a plant

10 point of view, I think it's extremely

11 important and it's an area that hasn't been

12 well investigated.

13 DR. JACOB: I mean I thought that

14 that chapter did justice on this issue, but I

15 must confess that I kind of forgot the

16 details. I don't know if Ted or George could

17 help with opinions.

18 MR. ALLEN: I would say it

19 actually does a good job. I mean if you look

20 at the diagrams and discussion, from 138 on,

21 it shows and adequately captures that you

22 don't have as strong a diurnal variation. 
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1 And it's well known. There's no mystery in

2 what's happening here. And the models

3 capture it, the measurements capture it.

4 DR. NEUFELD: Okay, I was just

5 asking.

6 CHAIR SAMET: Okay, so let me take

7 this back to sort of the starting point I

8 raised around the discussion from Daniel,

9 about the contribution of stratospheric

10 ozone, and then this issue of defining the

11 background. So again, I suggested that you

12 take on the lead role here, but these are

13 obviously points you will give emphasize to.

14 And I wonder if anybody else wants

15 to comment on these, Ted do you have any

16 comments?

17 DR. RUSSELL: I really don't have

18 any further comments. I think in writing up

19 our review we might have some clarifications. 

20 But maybe it's just I look at the concept of

21 where we are now. I think the EPA, you know,

22 they've done simulations and we have a
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1 relatively good understanding. At least I

2 thought we had a pretty good understanding,

3 and maybe Daniel is adding some extra

4 complexity that was to subtle for me. So in

5 terms of how EPA's doing it, I understand

6 what they're doing and I think it's

7 appropriate.

8 DR. JACOB: I'm sorry, what is it

9 that they're doing?

10 DR. RUSSELL: In terms of defining

11 the various different backgrounds and how

12 they go about the whole exercise. Yes,

13 there's uncertainty. I think the biggest

14 issue is how they actually deal with this

15 uncertainty, not the different definitions

16 and background and how they get there.

17 DR. JACOB: So the only issue is:

18 how do you define the stratospheric

19 contribution? I think a lot of the confusion

20 arises from the definition.

21 DR. RUSSELL: Okay.

22 DR. JACOB: Do you agree with
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1 that?

2 DR. RUSSELL: Yes, I agree with

3 that. I agree with that much then how you

4 can define or get to an appropriate

5 calculation of background.

6 CHAIR SAMET: Okay, other comments

7 on this chapter? Chris?

8 DR. FREY: I guess just from the

9 prospective of the earlier chapters and this

10 issue of Figure 3. I guess I was intrigued

11 by Daniel's comments that, you know, I

12 generally have been not satisfied with that

13 figure as a communication tool. But I think

14 if you also feel that it's overemphasizing

15 the role of the stratosphere, I don't know if

16 we just provide advice to EPA verbally or

17 whether the air group might propose an

18 alternative figure that draws on your

19 expertise. That might be helpful.

20 The other thing that I would note

21 is Figure 3.7, at least conceptually is

22 pretty simple and maybe that's a good figure
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1 to move forward. If in fact, it sounds like

2 there's a proposal or a recommendation to

3 elucidate these different definitions of

4 background a little more clearly in the

5 earlier chapters and having a graph to go

6 with that might be nice as well.

7 CHAIR SAMET: Okay, Fred?

8 DR. MILLER: I'd like to ask if

9 they're any data in the way of stratospheric

10 contribution to bound it to say it might be

11 ten percent or it might be 75 percent. 

12 Because I think what you're bringing up is

13 more of an academic argument in terms of

14 clarity, then it is a real impact as far as

15 the data measurements.

16 That's my gut feeling, but I don't

17 know. I was wondering if there was some data

18 that could support how strong this

19 contribution you think is, in terms of the

20 overall?

21 DR. JACOB: Yes, thanks, Fred. 

22 The reason I think it's more then just an
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1 academic argument is because it links to the

2 implication of whether that stratospheric

3 ozone is natural or could be affected by

4 human influence. And so it is clearly

5 natural if it is produced into the

6 stratosphere from the photolysis of molecular

7 oxygen. That's the natural source of

8 stratospheric ozone.

9 If it is produced in the lowermost

10 stratosphere, from processes that involve

11 lifting of gases from the troposphere, then

12 it's not clear at all. And my concern is

13 that attributing ozone to the stratosphere on

14 the basis of the trajectories of air parcels

15 and saying they originated from the

16 tropopause region should not be construed by

17 saying well, this is the natural background,

18 because it doesn't have to be. And this is,

19 I think, a fundamental point that has

20 implications for policy.

21 CHAIR SAMET: Okay, good. I'm

22 going to suggest that you be the lead on this
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1 and that we move on, because we have seven --

2 a lot of chapters to go. Okay, exposure. 

3 Ed?

4 MR. AVOL: So I'll be pretty

5 brief. I actually like this chapter and the

6 revisions that were made to it, on Chapter 4. 

7 There are a couple of small comments that I

8 included and only one that I want to

9 specifically raise here.

10 And that is on the Section 4.4.2

11 on ozone adverting Behavior. There's a

12 comment sort of made in passing that being

13 active outdoors when air quality is better is

14 a way to reduce the exposure. And I think

15 you got to be careful about how you phrase

16 it.

17 This will come up later in the

18 risk exposure assessment, because spending

19 more time outdoors with slightly lower levels

20 in exercise will end up with a higher total

21 exposure for the individual. And so the

22 implication -- I mean, it's a little bit of a
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1 subtle signal that we're sending there.

2 I think I'd just be a little

3 clearer or a little more careful about how

4 that's phrase and to relate it to the similar

5 activity level at higher levels. But just

6 going outside and exercising more doesn't get

7 you lower exposure.

8 CHAIR SAMET: Okay, thanks. 

9 David?

10 DR. CHOCK: I don't really have

11 any comment. I think they did an excellent

12 job on this chapter and I pass my time.

13 CHAIR SAMET: Okay, Helen?

14 DR. SUH: I agree with Ed and

15 David. I think it was a big improvement. I

16 particularly like the discussion, the monitor

17 siting and the populations and ozone

18 concentrations. I thought was a good job of

19 incorporating results from Chapter 3 and

20 carrying them forward.

21 I think I was, I don't know what

22 the word is, technology-challenged or
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1 something. My comments actual I think

2 reflect a earlier version of the ISA, so I'm

3 just revising it a little bit and I'll send

4 this forward for the more minor comments. 

5 But otherwise I'm fine.

6 CHAIR SAMET: Okay, so you were

7 volunteering Ed to be the summarizer?

8 DR. SUH: Yes, I did.

9 CHAIR SAMET: Will you accept that

10 nomination?

11 MR. AVOL: I guess.

12 CHAIR SAMET: Thank you, thank

13 you. I think it doesn't sound like this one

14 was a tough job.

15 DR. SUH: No, it was not.

16 CHAIR SAMET: Comments on Chapter

17 4?

18 (No response.)

19 CHAIR SAMET: Okay, Chapter 5,

20 Dosimetry. Jack?

21 DR. HARKEMA: So I'll try to be

22 brief too. Actually it's kind of
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1 interesting, I came out and reviewed this,

2 the first draft that went off in detail

3 reviewing and I came back a third time. So I

4 really liked it this time. I think they made

5 a lot of good improvements.

6 And I was very skeptical about how

7 they could match the dosimetry and the modes

8 of action. I didn't think it followed, but I

9 think now it does, to the best it can be

10 before you show the responses. So that's

11 good.

12 The very first figure, I think

13 maybe you can work on that and tweak that a

14 little bit more, so that the arrows seem to

15 be going up and down and it could be a little

16 bit more linear. And also the net dose of

17 ozone seems to stick out there.

18 And you kind of defined in the

19 figure legend but then you took it again. 

20 And I think maybe it still needs to be

21 defined some. It's a good pathway figure,

22 but it would be nice at the end of the whole
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1 document, 18 back to then, if you filled in

2 some of the missing links there that was

3 actually discussed about.

4 And one of those was the

5 extracellular lining fluid. That was a huge

6 amount of material talked about there and it

7 would be nice to incorporate it and maybe

8 make a summary figure at the end to bring

9 everything together.

10 And then knowing my pet peeve, as

11 I always do, that you shouldn't

12 superficialize the upper respiratory tract. 

13 And there's a lot of data on the short term

14 effects and the long term effects that

15 mentioned nasal lesions and the comments of

16 that. And so in my comments I kind of

17 emphasize that, just don't forget about the

18 pathology that goes on there and go through

19 the dosimetry a little bit more carefully

20 there as well.

21 And maybe the more important thing

22 in all the chapters -- I would just kind of
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1 make a general statement here, and I think it

2 could be brought out, is that you could refer

3 the overall concentration of exposure back to

4 dosimetry more.

5 You get lost at the end. The

6 reader gets lost kind of at the end about,

7 okay, what's really important in terms of the 

8 -- you know, what is the important

9 concentration ends up to be the important

10 dose?

11 I'll highlight a couple of studies

12 I think that, there were a lot of studies in

13 here about the modes of action with mode and

14 models and I think they're all appropriate

15 and they would get us to a better

16 understanding of what's going on here. But

17 there are studies, old studies, that were

18 done in non-human primates at UC Davis where

19 they were exposed to 0.15 parts per million.

20 And those are mentioned later on,

21 and I think it should be at least mentioned

22 up here, because those are the lowest
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1 exposure doses that were ever done in a non2 human primate model. So you could, in the

3 mode of action it quantified inflammatory

4 responses both in upper and lower respiratory

5 tract and it showed epithelial remodeling.

6 So I think just don't forget about

7 that. But overall I thought, at least my

8 colleagues seem to know more about the

9 dosimetry aspect to comment on that. But I

10 would end this with some firm summary figure

11 where you can better integrate the dosimetry

12 with the responses. And that would really

13 nicely tie in the whole chapter there.

14 Because the first figure is pretty

15 kind of superficial and the modes of action

16 is just -- but if you could kind of bring it

17 all together into a figure and that would

18 integrated it at the end. But overall, I

19 thought it was very nicely written.

20 CHAIR SAMET: Okay, thanks. Fred?

21 DR. MILLER: I have three

22 comments. First, I think that this is a
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1 greatly improved chapter and obviously a lot

2 of hard work was put into it.

3 My second comment is: you have

4 this chapter titled "Dosimetry and Mode of

5 Action," and yet a major part of the chapter

6 is on species homology. And I feel that the

7 chapter title could well be changed to

8 include all three. "Dosimetry, Mode of

9 Action and Species Homology." And that would

10 carry over into the Executive Summary as

11 well.

12 My last comment has to do with the

13 summary section on Page 528, 5.2.3.1. It

14 fails to capture some of the important facts

15 that have been brought out into the chapter. 

16 There's no mention of the ELF decreasing in

17 magnitude as you go distally in the LRT.

18 The Figure 5.7 gives the

19 impression to the reader that the only thing

20 of importance is the areas lined by mucus. 

21 And it doesn't even cover, really, the

22 surfactant layer. And so the depiction of
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1 that, I think, is going to be even more

2 important.

3 And I'll wait for Jim to provide

4 his comment. And if he doesn't make the one

5 comment that I hope he does then I'll be

6 jumping back in.

7 CHAIR SAMET: Okay, Jim?

8 DR. ULTMAN: The last review of

9 this chapter in the second draft, the general

10 comments we had that we wish the chapter to

11 have strengthening of the discussion of some

12 of the principles of dosimetry. More

13 discussion on extrapolation modeling.

14 Clear presentation -- or

15 separation between the direct contributions

16 of ozone versus reaction products. And

17 inclusion of relationships between physical

18 activity levels and breathing conditions that

19 can help inform the dosimetry that's

20 discussed in the chapter.

21 And I think the chapter's been

22 rewritten in a way that much improves all of
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1 these aspects. But I had a couple of them

2 that I wanted to comment on that I think need

3 a little bit more work in particular.

4 First of all, in discussing 

5 dosimetry principles. The chapter goes much

6 more deeper now into differences between

7 different types of mechanisms. For example,

8 just convection, because of the nature of the

9 velocity fields, versus diffusion. And

10 there's actually diffusion on two levels. 

11 There's kind of a longitudinal process that

12 goes on and then there's a radial diffusion

13 from the bulkheads to the walls. So there's

14 a lot going on here and I think that there's

15 some smoothing out and clarification of these

16 different types of mechanisms.

17 And I've given some specific

18 comments to help give you some guidance

19 there. That I consider to be a relatively

20 minor issue that can be fixed up pretty

21 quickly without adding, you don't have to add

22 more material, it's just a question, I think,
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1 of trying to be a little more precise with

2 what you have there.

3 But I think the only issue that I

4 found that was important or the only thing

5 that I found important that was lacking, and

6 that was generated because of the fact that

7 you put more discussion in, in terms of

8 trying to assess how important the reaction

9 products are versus ozone itself in reaching

10 tissue and causing damage. This is added

11 discussion which really helps the chapter.

12 However, in adding the discussion,

13 there were some points there that needed to

14 be clarified as well. And the most important

15 point I can make, kind of the bottom line is:

16 if you're trying to assess delivery of ozone

17 to the cells where it's going to do damage,

18 the important aspect of that are the

19 parameters, like reaction rate constants,

20 diffusion parameters, et cetera.

21 Those are the key ingredients that

22 go into making an estimation of how far ozone
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1 can penetrate. And if those parameters have

2 reasonable values, you can make that estimate

3 in a reasonable way. If those parameters

4 don't have reasonable values, then the

5 estimates are just guesswork.

6 And the reason why these estimates

7 are important is because if ozone can indeed

8 reach the cells, then the damage is not

9 necessarily by toxic products. However, if

10 you could prove that ozone can't get to the

11 cells, then the toxic products take on a

12 added importance.

13 So this is, it's not a trivial

14 kind of a calculation. And the bottom line

15 is, that there's a huge uncertainty in these

16 parameters. The reaction rate constants, the

17 concentration of substrates that are present.

18 And I think that it has to be

19 pointed out. And there's some literature,

20 there's plenty of estimates in the literature

21 that show that the reaction rate constant,

22 for example, can be orders of magnitude
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1 different by different investigators.

2 So I think the uncertainty of

3 these parameters and what it leads to in

4 terms of uncertainty and the prediction of

5 how far ozone can penetrate, I think is

6 something that should be improved. And you

7 made some attempt to do that, you did an

8 analysis of your own, but I think it can be

9 improved.

10 CHAIR SAMET: Okay, thank you. 

11 Fred, are you --

12 DR. MILLER: Jim almost kept me

13 from talking, but I'll just boil it down to,

14 one of the things he has in his comments is

15 based upon the Pyre -- not prior but P-Y-R-E,

16 the author. It shows that with the

17 variability that's present in the parameters,

18 that ozone can penetrate seven times more in

19 distance, then in what the Pyre thing is.

20 If you take that to the pulmonary

21 tissue, the alveolar region, instead of 0.1,

22 you're talking about 7/10 of a micron. And I
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1 have repeatedly said about the thickness of

2 the surfactant layer being only about 0.01

3 microns thick. So I am not willing to back

4 off, that a major part of the ozone effects

5 in the alveolar region is due to direct

6 penetration.

7 And I think you've laid out by

8 having more here and it's a complicated

9 thing. And that goes back to Jack's thing

10 about not really looking at the whole cadre

11 of the ELF as you go into the different areas

12 of the lung and the pictures that it takes.

13 CHAIR SAMET: Okay, thank you. 

14 And Fred, would you volunteer?

15 DR. MILLER: Would I what?

16 CHAIR SAMET: Would you volunteer

17 to summarize the comments for this chapter?

18 DR. MILLER: Yes, sure.

19 CHAIR SAMET: Thank you, comments

20 here? Okay, so Chapter 5 we're going, gone. 

21 Okay, Chapters 6 and 7. We may need a little

22 time here. Michelle?
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1 DR. BELL: Okay, I'm going to

2 hopefully be pretty brief. I thought these

3 chapters were greatly improved and I was very

4 impressed with what EPA has done.

5 Just some specifics, I thought

6 there was a good job of incorporating some of

7 the recent evidence. And it's clear that

8 special attention was paid to better describe

9 certain issues, like exposure assessment and

10 effect modification and the variation among

11 studies.

12 I actually don't have a whole lot

13 to say about these chapters, I thought that

14 text worked very well. Their quite extensive

15 use of tables and figures, but I thought they

16 worked well, and even though there's a lot of

17 them, I thought they were appropriate and

18 very helpful.

19 A couple of suggestions that I

20 don't think are major problems, but just

21 things that maybe could have mild

22 improvement. There's been a lot of work on
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1 these chapters to separate and better define

2 short term versus long term exposure, and

3 it's come a very long way and I very happy

4 with that.

5 But there may be a few places in

6 the text where that could even be better in

7 terms of separating impacts of long and short

8 term exposure. I know it's hard and there's

9 already been a lot of improvements, but that

10 might be something worth another read.

11 And kind of going the opposite

12 directions are the separating, thinking about

13 integrating effects, looking at interaction

14 and effect modification. I thought there was

15 almost too much separation of those concepts. 

16 So it may be worth another read to think

17 about those concepts together in the

18 document.

19 And with respect to cardiovascular

20 risks, there were recommendations made to

21 consider going from suggestive of causal

22 relationship to likely to be causal. And if
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1 you look through the comments, my own view

2 and that of many others on the panel, is that

3 at least I and many others would have

4 concluded likely to be causal.

5 But my recommendation before, and

6 I believe most peoples recommendation was to

7 strongly consider changing this designation. 

8 And I am satisfied that EPA did strongly

9 consider this point. So with the note that I

10 would have concluded likely to be causal, I

11 do believe that EPA did give very serious

12 consideration to the panel's comment on

13 cardiovascular risk.

14 CHAIR SAMET: Okay, thank you. 

15 Ana?

16 DR. DIEZ-ROUX: I don't have a lot

17 more to add. I think EPA has done a very

18 good job of responding to the prior comments. 

19 In general, it's a very thorough chapter. 

20 There has been a big effort to integrate some

21 of the literature on effect modification into

22 this chapter.
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1 One thing that I think would be

2 worth doing is, I'm not sure that it's always

3 consistently treated in this chapter and in

4 Chapter 8. And so making sure that the two

5 things line up, because not always the same

6 domains are considered and I'm not sure that

7 the same conclusion is always drawn. And so

8 making sure that those things line up would

9 be important.

10 There is this distinction made

11 between interaction and effect modification,

12 which I think is problematic. Most people

13 don't think of them as different things, so I

14 think that needs to be fixed.

15 In terms of the decision to retain

16 the suggestive of a causal relationship

17 categorization for the short term effects on

18 cardiovascular risks, I mean, I think you

19 guys have clearly considered it and have laid

20 out an argument. I myself, I mean, based on

21 the criteria that are laid out, including the

22 fact that I believe having controlled human
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1 exposure studies is not a requirement for the

2 likely causal relationship, as you have laid

3 them out. And now there is this new study

4 actually which finds some evidence of some

5 cardiovascular effects. That makes me lean

6 more towards the likely categorization. But

7 others will comment on this as well. That's

8 my assessment. I think that's it.

9 CHAIR SAMET: Okay, thanks. Mike?

10 DR. FOSTER: I really have nothing

11 substantive to offer. I think Michelle

12 summarized the fact that, Judy Graham really

13 pushed hard at the last meeting that all the

14 figures and tables, and they've been redone

15 terrifically. I think they're very, you

16 know, absolutely claret and no questions.

17 I think you guys should be

18 congratulated. And it's all really been

19 pulled together. I like the summary.

20 The other question, I think, was

21 about the cardiovascular, and I'm actually on

22 the side that it's only suggestive. I found
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1 to the committee that there's virtually very

2 little controlled laboratory studies that are

3 supportive of moving it to likely.

4 And I understand that there's a

5 difference here and maybe Sarah will have

6 something to say. But that's it John, thank

7 you.

8 CHAIR SAMET: Okay, and Sverre?

9 DR. VEDAL: Right, so I agree with

10 pretty much with what everyone has said and I

11 won't repeat that. I will elaborate a little

12 bit on the issue that everyone has touched

13 on, which is the designation of short term

14 effects on cardiovascular disease.

15 And everybody has heard that

16 basically the reasons why EPA has decided to

17 retain this as being merely suggestive has

18 been first of all the lack of human clinical

19 data and then secondly the -- and then we saw

20 that in detail, the inconsistent and largely

21 negative findings from the morbidity studies.

22 And I think those are both fair
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1 arguments. We had argued before that the tox

2 was pretty strong, that the mortality data

3 were pretty strong. And if you're going to

4 conclude, for example, the effect on total

5 mortality and that's driven by

6 cardiovascular, there's almost a logical

7 inconsistency there.

8 And there has been some allusion

9 to newer human clinical studies, which is a

10 little bit unsporting because, you know,

11 they're recent. And one is from EPA.

12 It's a very critical study, is the

13 one by Bod Devlin, just published in July,

14 which is probably the most prominent now

15 study on human controlled -- study of

16 cardiovascular effects. And it's pretty

17 solid in my opinion.

18 There haven't been many that have

19 tried to address those end points and they

20 did. So I think you've heard from the

21 committee, well not consistently, but I think

22 we're still going to stand by our
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1 recommendation. I think you did a nice job

2 of really considering our recommendation and

3 there's no question about that.

4 You laid out the argument very

5 clearly and I think we were happy about that. 

6 But I think at the end of the day there's

7 going to be a difference of opinion on where

8 we come down.

9 I'll be very quick. I still find

10 allusions and some of the control trial

11 people that may disagree with me, but I still

12 find allusions and there's a knee-jerk

13 tendency to attribute that asthmatics do

14 worse in everything in controlled studies.

15 And my read of it is different,

16 at least in the lung function arena. That

17 has been hammered so much originally, and it

18 was counterintuitive that asthmatics did not

19 seem to respond differently from non20 asthmatics to lung function effects. And

21 yet, you've kind of drummed up a little bit

22 of data that to me would suggest that
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1 asthmatics do respond differently.

2 Just specific to the lung function

3 stuff. I agree that there are other end

4 points where asthmatics seem to do worse. 

5 But I still don't think that the evidence is

6 there to suggest that asthmatics respond

7 differently in terms of the lung function

8 effect.

9 And I think that makes perfect

10 sense, from what we understand about the

11 mechanism of why that happens. It has little

12 to do with why someone is asthmatic or not

13 when you're attributing this to a

14 neurological mechanism.

15 I won't talk about long and short

16 term exposures, there's still some residual

17 stuff in there and you've done a nice job of

18 that. Ana mentioned the issue of effect

19 modification and interaction.

20 I'll just make one thing, I mean,

21 you basically define interaction in a very

22 specific way and then go ahead and use that
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1 definition. And you know, it's all right, I

2 guess, if you actually make the point that

3 that's what you mean by it. But in fact

4 nobody else means that when they talk about

5 it, that they are synonymous.

6 And then finally, on the short

7 term effects, I'll again make the point that

8 I had before, is that you've got on asthma

9 symptoms and medication use in panel studies. 

10 You've got these two multi-center studies

11 staring you in the face that show basically

12 very little evidence for effects.

13 If you could just say why you

14 don't put any weight on those studies, I

15 could understand why you might still maintain

16 what you say. But it doesn't support an

17 argument that this is a consistent picture.

18 And so you're going to have to

19 say, and specifically I'm talking about the

20 Schildcrout and O'Connor studies, why you

21 don't weight them. And there may be good

22 reasons for that.
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1 I could understand why you might

2 disagree with me in terms of how you view

3 them. But it needs to be, you don't want to

4 have those effect estimates from these multi5 center studies here and then go and conclude

6 that you've got this beautifully consistent

7 picture. You have to have a reason for

8 saying you do that.

9 The long term effects. One point,

10 well, let's see, maybe two points I'll make. 

11 And it's a point I've made before, is that it

12 has to do first of all with new onset asthma.

13 And the argument that that is the

14 strongest epidemiologic evidence that's out

15 there for long term effects on respiratory

16 end points is new onset asthma. And it's

17 largely based on, again, the California

18 Children's Health Study data.

19 Which consists, to me, of two

20 pieces. One is what I would consider to be

21 basically pilot study stuff, which is the

22 initial work on children who exercise
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1 outdoors. It's a great thought in terms of

2 exposure and trying to be a little bit more

3 precise about things that modify exposure and

4 therefore where you might seem to see an

5 effect. But I think it's, to my mind it

6 still pilot type of study and it's, well, I

7 won't say more about it.

8 The second one is based on many

9 more new onset asthma cases, but as I've said

10 before, it's a gene/environment interaction

11 study and the primary focus is on the genetic

12 effects and how ozone modifies that. Whereas

13 in this context, we're interested in the

14 ozone effect.

15 There is no ozone effect on new

16 onset asthma. There is this interaction

17 effect, and to me that's a second order

18 interest. There is no main effect on new

19 onset asthma in the Children's Health Study.

20 So it's a just a bit of how one

21 orients your look at those types of findings. 

22 Now you could argue that this interaction
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1 effect is the most important thing after all

2 and that's the way it sort of reads. But to

3 my mind it isn't.

4 And then let's see. One last

5 thing had to do with, again and it's

6 important as you look to the future, future

7 work that's plan to be done for the risk

8 assessment. It comes up later, but it has to

9 do with how you view long term and short term

10 exposure effects. And we've alluded to that

11 a little bit.

12 Just again be careful about

13 attributing effects to long term exposure,

14 when you have end points that could be short

15 term exposure effects. And particularly

16 referencing or talking about the Lin Study,

17 that's going to come up for consideration for

18 future look in the REA part.

19 It will come up again. Just have

20 another look at that as to whether in fact

21 they have a good job of separating those two

22 components of exposure.
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1 CHAIR SAMET: Okay, thank you. 

2 Did I hear you end by volunteering to

3 summarize this? Thank you.

4 You know, just a comment on this

5 likely and suggestive. I mean I think the

6 importance, I mean there's empiric work, I

7 mean you know that there's variation and

8 expert judgments is actually empiric work on

9 this around these criteria.

10 But it seems to me that what you

11 are doing is you make these determinations,

12 you're setting the cases in motion. Which

13 say how you will interpret the evidence.

14 And so I think that is perhaps why

15 it's worth some back and forth on this point. 

16 So that it's clear that if you stay

17 suggestive, everyone knows why you have said

18 suggestive.

19 I think the other point is if you

20 regard the new Devlin study that's somehow

21 pivotal and changing the classification, then

22 I think you need to give that consideration. 
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1 And then of course I get you on the slipper

2 slope of considering new evidence, which you

3 know, as we understand is problematic.

4 So I think you know, we will offer

5 in these comments our views and recognizing

6 that other views are tenable. Other comments

7 on Chapters Number 6 and 7?

8 DR. HARKEMA: Chair, I just want

9 to clarify. So the Devlin paper's actually

10 going to be cited in the revision?

11 DR. VEDAL: No it's not.

12 DR. HARKEMA: It's not going to

13 be?

14 DR. VEDAL: No.

15 DR. NUGENT: Excuse me Jack, could

16 you use the mic?

17 DR. HARKEMA: Oh certainly. I

18 just wanted clarification because I've heard

19 that the Devlin study was a pivotal, key

20 study and whether it's going to be used or

21 not in the revision?

22 CHAIR SAMET: So my comment was,
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1 if it regarded as pivotal would it be

2 included? And then that of course brings the

3 problem of the fact that there is always new

4 evidence. So John, do you want to comment?

5 DR. VANDENBERG: Maybe two

6 comments. One is that you can certainly

7 recommend that we include specific studies,

8 in the past CASAC has done that. We've

9 brought those in even at this stage in the

10 game. And then I think I'll just stop with

11 that.

12 DR. VEDAL: I'm sorry, what was

13 that?

14 DR. VANDENBERG: If the CASAC

15 committee recommends that we include certain

16 specific studies, as was done in the last

17 letter actually to bring in some new studies,

18 we certain would consider that recommendation

19 very seriously.

20 CHAIR SAMET: Mike?

21 DR. FOSTER: Just that Jack,

22 understand that the word pivotal, people that
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1 do chamber studies, this was the small data

2 set, less then 25, and it was at a single

3 dose. And as the EPA scientists sometimes

4 do, it was an effective dose, okay.

5 And it's no where near the

6 standard. It's probably four times the

7 standard, five times the standard.

8 DR. HARKEMA: No I just --

9 DR. FOSTER: So I don't know what

10 you want to call that, pivotal in a small

11 data set.

12 DR. HARKEMA: Yes, I don't really

13 care if it's pivotal or not pivotal. I just

14 want -- it's a study out there that addressed

15 that and it's one of the, what I heard from

16 the people that really looked at it, the

17 chapter in depth, that it's something that I

18 would think would have to be addressed. Is

19 it or not and do you go through the same

20 exercise we do with all non-pivotal or

21 pivotal studies?

22 But anyway it's one of the first I
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1 think, right? It's worth looking at.

2 DR. MILLER: Well I think further

3 beyond what Mike has said, on the other hand

4 the magnitude of the changes seen show that

5 there is ample room to go way, way down with

6 this. So it comes back to, I think this give

7 back and forth as John is mentioning here,

8 about how you come to your conclusion and

9 articulate that? Because not mentioning it

10 at all I think would be a mistake.

11 CHAIR SAMET: Okay, so this might

12 be reflected in our comments that this new

13 study has been published. And again I think

14 we're certainly sympathetic to the fact that

15 the literature is always evolving. Only the

16 most important studies in one light or

17 another should be considered. Certainly this

18 light phases of the ISA.

19 Other comments? We're on Chapters

20 6 and 7? Okay, then Populations at Risk. 

21 Ana?

22 DR. DIEZ-ROUX: Okay. I think
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1 also this Chapter's substantially improved

2 and I think EPA took the comments that we

3 made very seriously. Which I think is very

4 commendable.

5 A major improvement has been the

6 addition of this categorization scheme for

7 the evidence. Which I think is very good. I

8 think there will be room for further

9 elaboration on that, because it's kind of a

10 complicated topic. But I'm sure in future

11 ISAs they'll be room to flush that out a

12 little bit more.

13 I guess the one kind of comment

14 that I continue to have is that I think,

15 although the chapter has moved in the right

16 direction, I think there is still some

17 conflation of the discussion of factors that

18 cause certain groups to be exposed to higher

19 levels versus factors that modify the effect

20 of the exposure on the health outcomes. And

21 you kind of recognize that in the

22 introduction, but then you say, well they're
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1 all kind if related so we're going to talk

2 about them altogether.

3 Which I guess is okay, but to me

4 analytically it still makes sense to

5 differentiate those two things. And I think

6 effectively what happens is that most of the

7 chapter really focuses on the effect

8 modification side.

9 And the criteria that you're using

10 to classify whether there is or this is not

11 evidence that certain populations are "at

12 risk", is really mostly based on effect

13 modification as opposed to certain subgroups

14 that may be at risk, because they're at

15 higher levels of exposure period. Even if

16 that exposure is not more detrimental to them

17 then it is to other groups. They're at

18 higher levels of exposure so they have higher

19 risks.

20 And this is very clear for things

21 like SCS and RACE. For example, where

22 perhaps the evidence of effect modification
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1 is not as clear, maybe a little bit more for

2 SCS then RACE as you recognize.

3 But certainly there's a whole

4 bunch of literature that shows differential

5 exposures for these groups, which is not

6 really reviewed here much in terms that, so I

7 don't know how much there is for ozone,

8 certainly for other pollutants there is. But

9 I mean -- so my main point is that I think

10 distinguishing factors that, characteristics

11 that are associated with increased exposures

12 versus those that enhance the effect of the

13 exposure.

14 Still, I think is something that

15 the document could grapple a little bit

16 better with. You do talk about the

17 distinction between intrinsic and extrinsic. 

18 That may have some roots in this you know.

19 Perhaps there was an attempt

20 earlier to equate, I don't know, but equate

21 maybe intrinsic factors to factors that

22 modify the causal effect of a factor where as
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1 the extrinsic factors maybe related to higher

2 exposure. But in fact extrinsic factors may

3 also modify the effect of the exposure.

4 So I didn't find that, extrinsic 

5 intrinsic distinction that helpful. But

6 that's my opinion. So I think the chapter is

7 substantially improved and has really moved

8 in the right direction.

9 CHAIR SAMET: Okay, thanks. Jack?

10 DR. HARKEMA: So the only comment

11 I am going to have, I thought so too is

12 really improved. One suggestion I would give

13 is on the tables that you used for the

14 genetic factors in there. It would be nice

15 to have some documentation of some metric of

16 exposure. Something in there that could tie

17 those studies back to ozone exposure.

18 And then also if you could also do

19 another table, if you wanted to, on

20 controlled human and animal exposure studies

21 and use that same framework. But instead of

22 talking about each exposure or each exposure
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1 metric in the text, you could just summarize

2 like you did in those tables.

3 Otherwise I thought it was well

4 done. I have some comments t0o of some other

5 -- these are really minor and I don't really

6 know if it's appropriate or not, but there

7 are a few studies in cystic fibrosis. I

8 think one you guys did out there that wasn't

9 mentioned is whether or not that could be

10 added to the list.

11 And there are a couple of studies

12 in diabetes, but again it could be like we

13 talked about like in Devlin paper. So whether

14 you want to include it or not it just

15 suggestions.

16 CHAIR SAMET: Okay, thanks. Jim?

17 DR. ULTMAN: Yes I think the

18 rewriting on this chapter was very well done. 

19 And I did particularly appreciate the

20 synthesis of the different types of studies

21 using this new table that differentiates the

22 different levels of possibility for somebody
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1 being in a at risk group.

2 In fact I thought that paradigm

3 should actually go into the -- might go into

4 the preamble at some point. Not necessarily

5 in this document, but in future document that

6 you do.

7 I was curious about though the

8 rational for, you know, in the causality

9 table there's one more classification. It

10 seems in this table you combined two of the

11 classifications that were in the causality

12 table into one. So it's almost as if you

13 took the same table and you used that as a

14 template.

15 The causality tables a template

16 for the at risk table and the decided that

17 one of the categories was unnecessary. So

18 maybe some kind of an explanation. I don't

19 recall reading an explanation of how you

20 developed that particular classification

21 system.

22 I did think though that the
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1 chapter did do a good job of drawing a

2 distinction between exposure in dose versus

3 biological sensitivity. I was satisfied from

4 my perspective with having insights into

5 dosimetry. That at that level that was done

6 very well.

7 CHAIR SAMET: Okay, Steve?

8 DR. KLEEBERGER: So I won't

9 reiterate what all my other colleagues have

10 said, except there is one point that I would

11 perhaps like to suggest might be

12 reconsidered. And that is the classification

13 of the role that genetic effects has as

14 suggestive to adequate.

15 I understand how that

16 classification was sort of realized, but I

17 would argue that in fact the evidence is more

18 supportive of their being adequate evidence

19 for the role of genetic background and

20 responsivity to ozone. I think the

21 toxicological studies in animal models, in

22 particular, are very, very strong.
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1 Human studies, while perhaps not

2 consistent, doesn't mean that there isn't a

3 role for genetics in susceptibility. So I

4 would ask that you might reconsider that

5 classification. All my other comments that I

6 have are relatively minor and they're written

7 up in the document so I won't reiterate

8 those.

9 CHAIR SAMET: I think your point

10 on the classification goes back, again since

11 this table and this idea is new, just

12 probably being very clear about why you are

13 placing one or another factor within a

14 particular category?

15 And again I think we can always

16 anticipate variation and view points, but I

17 think perhaps the way he told the story was

18 not convincing to Steve, at least. Other

19 comments here on this? John?

20 DR. VANDENBERG: I'd just like to

21 make the CASAC aware that the next iteration

22 of a lead ISA, the third draft, we brought
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1 the same ideas forward in terms of the at

2 risk populations chapter based on the

3 comments around the ozone one. So you'll be

4 seeing this.

5 It's very helpful to get your

6 comments on this, because it is a new

7 approach and so hopefully we'll be able to

8 bring that right into the next iteration on

9 lead, which we anticipate finishing up early

10 to mid October to distribute to you. So

11 again, very much appreciate your comments

12 here.

13 CHAIR SAMET: Okay. Joe, did you

14 have a comment?

15 DR. BRAIN: Yes, I keep thinking

16 about adaptation and how important it is in

17 ozone. And I wonder whether a population at

18 risk are people who rarely see ozone and then

19 suddenly are exposed to it at higher levels,

20 compared to those who see steady state

21 levels?

22 I mean I think that is an
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1 important population at risk, but I suppose

2 whether there's adequate supporting evidence

3 for that or not?

4 DR. VANDENBERG: I'm not aware of

5 any studies actually, but --

6 DR. BRAIN: Well it's certainly in

7 the animal literature. I mean you could,

8 well.

9 CHAIR SAMET: We'll take it into

10 consideration. I will comment, I want to go

11 back on this question sort of the precision

12 of concepts, which Ana was sort of getting

13 at.

14 I still think in your sort of

15 preamble materials you could just sharpen

16 things up. And without insult to authors,

17 but when I read something that says, some

18 factors described above are multifaceted and

19 may influence the risk of an air pollutant

20 related effect through a combination of

21 avenues, I'm left scratching my head frankly.

22 And I think if you could just
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1 sharpen this up. And I think we've given you

2 some guidance and prior letters about how to

3 do that. I mean I think many view this text

4 as okay, but I think it could be better.

5 And again, because this is sort of

6 model text leading to your new table and this

7 idea at risk extends across all the

8 pollutants. I mean think you just want to

9 get it as good as it can be and it can be

10 better I think. And I think that's what --

11 DR. DIEZ-ROUX: Yes and I think,

12 if the intent is to encompass within

13 populations at risk, both effect modifiers

14 and factors that increase exposure period. 

15 And the second part of that, increase

16 exposure period, needs to be given more

17 attention.

18 Because most of it is focused,

19 most of the discussion is really about effect

20 modification. If that's what you want to do

21 that's fine, but then don't say that you're

22 considering both things. Because they're two
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1 separate things that place people at higher

2 risk ultimately.

3 CHAIR SAMET: And then of course

4 not forgetting dose, which is the other --

5 DR. DIEZ-ROUX: Right, that's also

6 part --

7 CHAIR SAMET: -- the other piece

8 of this and that will become very important

9 later on. And clearly will be important for

10 some of the other pollutants as well. So

11 other comments Chapter 8? Helen?

12 DR. SUH: I guess I'm puzzled. So

13 with effect modification wouldn't you also

14 see that if you had higher doses of a same

15 given or this higher exposure as a same given

16 ambient level? So you would see the effect

17 modification just because it would be exposed

18 more.

19 So it's not really the effect

20 modification that's the issue, it's really

21 more the issue is whether or not, it's

22 something about the intrinsically or suddenly
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1 that they had increased exposure?

2 DR. DIEZ-ROUX: Yes. So sometimes

3 differences in internal dose can be

4 manifested as effect modification between

5 ambient levels and the factor. And I think

6 we had some elaboration of that in the

7 comments last time and I can go back and

8 restate that.

9 But I think still there are other

10 factors that increase the effect of the

11 exposure or the dose, that are completely

12 different from the ones that increase the

13 dose at a given ambient exposure. So I think

14 distinguishing these things clear is really

15 important and I'll try to suggest some

16 wording along those lines, again if I can,

17 that you may want to consider.

18 CHAIR SAMET: And would you take

19 on the role of summarizing the comments for

20 this, good, thanks. So we'll leave Chapter 8

21 and move on. So we'll move onto Chapters 9

22 and 10, absent, Kathy's not able to be one
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1 with us, so Peter I guess that leaves you as

2 the person?

3 DR. WOODBURY: I don't have any

4 comments on either 9 or 10 at this time. 

5 Thanks.

6 CHAIR SAMET: Okay. Howard?

7 DR. NEUFELD: Okay, I have a

8 number of comments but I'll be very quick. 

9 But I want to go back, I did read Chapters 2

10 and 3 and just in case EPA is wondering where

11 this mysterious paragraph is that I thought

12 was contradictory in my first comment, it's

13 Page 2-22. I left that out.

14 Figure 2.3 talks about leaf

15 production and I just wanted make the

16 distinction between leaf production, leaf

17 senescence. The document mainly concentrates

18 on senescence, but there are studies looking

19 at effects of ozone on production. So I've

20 made some suggestions in this paragraph that

21 maybe EPA could take advantage of.

22 And in Chapter 3, there is an
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1 equation on Page 106, it's Equation 3.1. I

2 looked at and unless I'm just not seeing it,

3 the numerator and the denominator appear

4 identical. So no matter what you stick into

5 the equation it's always going to come out to

6 one. So maybe there's a typo in there.

7 Now to Chapter 9. I'll just

8 concentrate on a few of these things. Figure

9 9.2, I know is a simplified diagram, but it

10 seems that in every document we always do

11 this. We always put all the stomata on the

12 lower surface of the leaf. There are some

13 crops, I think beans are one example, that

14 actual have equal number of stomata on upper

15 and lower surfaces.

16 So it's not true that all plants

17 only have stomata on the lower surface. I

18 don't know if that's a detail you need or

19 not.

20 There seems to be a revision of

21 thinking too, considering the role of

22 apoplastic antioxidants. And I just
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1 mentioned a recent paper that came out really

2 goes into the detail. I don't know if you

3 have time, I don't want to keep adding new

4 references every time we revised the ISA, but

5 this is an important paper.

6 The other distinction is on Page

7 31 in this chapter. You talk a lot about the

8 quantity of RUBISCO being effected by ozone. 

9 There is some mention of activity, those are

10 two different things with respect to the

11 enzyme. So it would be nice maybe to

12 elaborate a little bit more on what activity

13 is as opposed to quantity.

14 There is one paper I think that

15 you do need to add. It's by Gretchen Smith. 

16 This summarizes 16 years of monitoring. It's

17 probably the largest single date set on

18 ambient monitoring of full year ozone

19 effects.

20 And particularly there's a good

21 discussion of the role of soil and moisture

22 and symptom expression. It doesn't change
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1 any of the major conclusions in the ISA, but

2 I think this is an important document to add.

3 On Page 56 on Lines 3 through 27,

4 there's a summary of a study by Weinstein and

5 others. At first I was very confused by

6 reading it then I thought more about it, then

7 I finally got hold of the paper.

8 I think generally, the conclusions

9 of that paragraph are correct, but maybe it

10 just could be rewritten to be a little bit

11 more clear. Because this is confusing in the

12 sense that you have a very sensitive species

13 that initially is more effected, it says in

14 there, by the competition with it's

15 neighbors, then it is by the ozone. And yet

16 it's ranked maybe the second most sensitive

17 tree species to ozone.

18 It just seems unusual. So a

19 little more clarification on this section

20 about competitive interactions and the

21 modeling effort to how they come to that

22 conclusion in that section. I think that
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1 would just help.

2 On Page 63, the document notes

3 that there does not appear to have been any

4 selection for more ozone resistant genotypes

5 of crop plants in the past several decades. 

6 That's fine. But you know farmers could

7 actually be planting more resistant

8 genotypes.

9 I've been asking around in people

10 at the USDA, do you have any evidence that

11 farmers are inadvertently or cautiously

12 trying to plant more resistant crops? And

13 yesterday in the discussion there was an

14 anecdotal mention that they didn't think

15 there was any difference in the varieties

16 that are planted now as opposed to ten or 20

17 years ago. So probably they aren't doing

18 that, but it might be something just to

19 mention.

20 And the last things are on Page

21 80. Maybe the EPA could consider indirect

22 changes in litter decomposition due to ozone,
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1 which is resulting from a change in the

2 canopy, which then causes microenvironmental

3 changes down at the soil level.

4 And the last thing was, I didn't

5 see any emphasis on ozone-disease

6 interactions in here. Either for the way

7 that if a plant is more or less susceptible

8 to fungal or bacterial infections after being

9 stressed by ozone or those kinds of

10 interactions?

11 And I think we also still need to,

12 even though it was probably well done in the

13 2006 document, nitrogen deposition continues

14 to be a major problem. And there appears to

15 be some contradictory literature out there

16 concerning ozone nitrogen interactions in

17 plants.

18 So even if it was brought up in a

19 2006 document, I think the nitrogen ozone

20 interaction should still be discussed. Even

21 if briefly. And other then that I just want

22 to say that overall I thought this is was a
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1 very improved document and I was well pleased

2 with it. Thanks.

3 CHAIR SAMET: Okay, Dave?

4 DR. GRANTZ: I agree with Howie, I

5 like this chapter quite a lot and I think

6 it's a very important summary of at least

7 vegetation effects. Maybe not so much some

8 materials and other welfare effects.

9 They're a couple of points that I

10 want to say in support of being a very good

11 chapter and then these will lead into a few

12 criticism I think. Again I'll say that it's

13 very important that the chapter reaffirms the

14 validity of the open top chamber studies.

15 That's just really critical. It's

16 been said before, but it's very, very

17 important compared with a number of

18 chamberless designs. Including the free air

19 exposures, ambient radiance and the open

20 tops.

21 The ISA does a good job of

22 carrying an enormous amount of agricultural
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1 crop research adequately summarized. I mean

2 Chapter 9-17 has four pages of single spaced

3 studies on crops.

4 I bring this up because it's very

5 important that, that get maintained through

6 the discussion because when you get to the

7 PA, which we're not talking about today, you

8 drop it. So I need to say right now during

9 the discussion of the ISA, that this is

10 critical data.

11 These are the species about which

12 we know the most. You say in the ISA that

13 these effects have been known since the '60's

14 and that is correct. And they've been

15 refined ever since and we have quantitative

16 relationships to drop that as not science

17 based, I think.

18 Okay, the chapter also does a very

19 nice job, this is to exposure of vegetation. 

20 The chapter does a really nice job of

21 introducing the new concept of flux, as a

22 measure of exposure, and then for the moment
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1 dismissing it. I'm sort of sad that we have

2 to dismiss it. I think it's biologically

3 very relevant.

4 But I agree with the conclusions

5 that it's not ready for prime time. So I

6 don't disagree with that, but I think it's

7 important that you bring it up and I think

8 you did a good job.

9 However I disagree a little bit

10 with Fred's comment earlier. I think the

11 theoretical basis for something like the W126

12 is laid out pretty nicely in this chapter and

13 I think that's very important. And given the

14 history in this group and this regulation, It

15 think it's a very to cast that -- reaffirm

16 its support for some of accumulative and

17 weighted metric such as the W126.

18 This is critical. And I think the

19 ISA does a good job of laying out a reason

20 why that might be important. So again, the

21 ISA does a good job, but I think it's

22 important to reiterate that.
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1 Okay, now I do have a few

2 criticisms based on criticisms that I made of

3 the second external review draft. And these

4 are in my written comment, I'll just

5 summarize them quickly. They have to do with

6 water relations of plants.

7 Now these aspects don't lead

8 directly into the risk assessment. And so to

9 some extend may be less important to the

10 agency. But if this is an integrated science

11 assessment it's important to get the science

12 correct.

13 There are aspects of stomatal

14 regulation and how it's impacted by ozone

15 that are at least a little fluffy if not

16 incorrect, with respect to opening in

17 response to certain levels of ozone. I'm

18 thinking of the work of Nancy Grulke with

19 black oak, for example.

20 The importance of sluggishness. 

21 The proper interpretation of Sandy

22 McLaughlin's data indicated decreased string
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1 flows. These all indicate that stomata may

2 not always close in response to ozone. And

3 while there's one section in the ISA that

4 kind of pays lip service to that, overall the

5 standard is well ozone closes stomata and you

6 discuss from that point.

7 This is with relation to stomata

8 regulation of water loss. When the

9 discussion gets to hydraulic conductance,

10 there are some factual inaccuracies that have

11 to be addressed. And these are in my written

12 comments and I don't need to go through them. 

13 But there are some aspects that I believe are

14 just incorrect, that I think somebody ought

15 to go back through and rethink.

16 Okay, so I'll leave that. You can

17 look at my written comments.

18 Something I've mentioned before,

19 the draft continually refers to detection of

20 ozone and how plants detect and sense ozone. 

21 I don't think they do. I think this is wrong

22 and I think it leads to kind of a wrong way
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1 of thinking.

2 Plants, they do respond to certain

3 things. They sense things like jasmonic

4 acid, methyl jasmonate in the air. They

5 sense that. But if you take a hammer and hit

6 a plant, you will find reaction. But they do

7 not have a hammer sensor, they don't -- okay.

8 So really it is an important

9 difference and I would, it's the third time

10 I've said this, I won't say it again I guess

11 but I would go back and think about that.

12 And then there's just a certain

13 defensive tone that I'm positive I know where

14 it cam from, but there's a certain defensive

15 tone in some of this chapter that we could

16 probably drop. Both for brevity and because

17 we can assert things with a certain amount of

18 confidence I think.

19 And just to refer to one, there

20 also in my written notes, but to refer it's

21 the section, Page 912 on Proteomics. Well

22 the recent proteomics research support
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1 everything else we know. That's great.

2 But instead that section starts

3 off with, well there could be this problem

4 with proteomics and there could be that

5 problem and there could be this other

6 problem, but in fact it supports it. Well I

7 would drop all those problems and say it

8 supports it, because it does.

9 I think all, no there is one more

10 thing. The summary refers to how acute and

11 chronic exposures to ozone lead to very

12 different mechanisms. This may or may not be

13 true. A lot of molecular people think it's

14 absolutely true. I'm not so sure.

15 But that summary doesn't follow

16 any discussion of that topic. So if you're

17 going to mention it at least lets discuss why

18 that might be or might not be the case. 

19 That's Page 967. Thank you.

20 CHAIR SAMET: Okay, good thanks. 

21 And would you take on the summarizer role?

22 (off the record comments)
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1 DR. GRANTZ: Okay.

2 CHAIR SAMET: Okay thanks. Okay

3 other comments, Fred?

4 DR. MILLER: Well Peter I'm not

5 disagreeing that the W126 and the sum aren't

6 laid out in there, but the Section 9.7 on the

7 summary of conclusions doesn't make the final

8 stab that this is not the same as just

9 considering the same as the primary standard. 

10 And it departs from the conclusiveness with

11 which the 2008 review really articulated at

12 the end that crops and vegetation require a

13 different form the health effects.

14 And so I was not disagreeing that

15 it's not laid out it is, but they don't say

16 the bottom line. And I think you have to say

17 the bottom line you have to carry it over

18 into the Executive Summary.

19 The Executive Summary just says,

20 well the current is in the primary and the

21 secondary are the same level. And so I'm

22 getting at the final conclusion of the
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1 deliberations, that to me they made the case

2 but in the end they don't state it.

3 DR. GRANTZ: Okay.

4 CHAIR SAMET: Any comments on,

5 nope. Okay, other comments on Chapters 9 and

6 10?

7 DR. GRANTZ: Actually I didn't say

8 anything about Chapter 10, if I could

9 briefly?

10 CHAIR SAMET: Okay, yes.

11 DR. GRANTZ: I don't know if this

12 is even feasible really, but in my written

13 comments I suggest that if one could relate,

14 even semi-quantitative ways the effect of

15 ozone on ultraviolet radiation, tropospheric

16 ozone on receipt of ultraviolet radiation? 

17 There is a certain amount of information on

18 ultraviolet effects on plants.

19 And so that connection would be

20 very appropriate in the ISA I think. And

21 it's not made, it's sort of in there as a

22 place holder argument. Now whether that
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1 could be done at this state or even could be

2 done from the literature I'm not sure. But

3 that did strike me as something that was kind

4 of weakly suggested but could possible be

5 quantitative.

6 CHAIR SAMET: Okay good. Anything

7 else, we're about to leave the ISA behind us. 

8 Okay, so let me remind you then, we are now

9 breaking for lunch. We actually have to be

10 back at 1:40. The main reason is that we

11 actually have to be out at 5:00, because the

12 room is going to be used by others

13 apparently.

14 So we have a lot to do this

15 afternoon. We actually have a public comment

16 period that in fact will be longer then it

17 is, because we have nine public commenters by

18 my count which probably will run at least 50

19 plus minutes. So we may, it would be nice to

20 get through everything we want to on the REA,

21 but let's see how that goes.

22 So if I understand what you're
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1 suppose to do for lunch, it's suppose to get

2 out of here and quickly fine a place where

3 you can buy food and eat it and get back

4 1:40. Good luck.

5 (Whereupon, the above-entitled

6 matter went off the record at 12:54 p.m. and

7 resumed at 1:48 p.m.)

8

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 (1:48 p.m.)

3 CHAIR SAMET: Okay, we're going to

4 go ahead and get restarted here. Moving on

5 to the Health Risk and Exposure Assessment

6 document. And I guess we're going to begin

7 with Lydia Wegman. Lydia, please.

8 MS. WEGMAN: Sorry, Jon. Okay. 

9 Thank you and let's see. Oh, I can't see

10 down there. Okay, great. Thank you,

11 everybody. Let me reiterate what John

12 Vandenburg said thanking all of you for the

13 work you have done in reviewing these

14 documents.

15 We are extremely appreciative of

16 all the time each of you has taken to review

17 not just the ISA but the REA and the policy

18 assessment. We recognize it is a huge amount

19 to go over for one meeting.

20 And your dedication and your

21 willingness to spend the time of doing this

22 is extremely valuable to us. So I just want
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1 to thank you again for doing all that work.

2 I'm going to just do a brief

3 overview of a couple of key points, some of

4 which we've talked about before. And then

5 I'm going to turn it over to Bryan Hubbell.

6 And let me note, Karen Martin who

7 normally would be here to do the second

8 presentation is sick today. So unfortunately

9 she can't be here. I don't know if she'll be

10 here tomorrow or Thursday.

11 I certainly hope so, but I sort of

12 doubt it. However I believe she's on the

13 phone listening. So she is keeping track of

14 all of us, as she always does.

15 And with me here is Zach Pecar,

16 Bryan Hubbell, Karen Wesson and John

17 Langstaff, and they'll all be doing pieces of

18 the discussion related to the Risk and

19 Exposure Assessment.

20 Okay. And I should note, there

21 are many other EPA Office of Air Quality

22 Planning and Standards staff over here. Ben
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1 Wells, Heather Simon, Susan Anenberg and

2 others in the back, all of whom have

3 contributed to this effort.

4 Okay, I want to start by just

5 reminding you all of the schedule for the

6 whole review. Jon showed you the schedule

7 for the ISA, which is the top block here.

8 And you can see in the middle

9 block and in the bottom block, our meeting

10 going on this week. We are hoping to have a

11 second draft of the Risk and Exposure

12 document and the policy assessment out in

13 late winter of next year, by which we mean

14 February or early March. That is our hope.

15 And then to have a CASAC meeting

16 with you sometime in May or early June. So

17 that's our goal heading into next year.

18 And then we hope to have the final

19 documents for both the REA and the policy

20 assessment done by summer of next year and

21 heading toward a proposed rule in December of

22 next year with a final rule in September of
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1 2014.

2 I know this may seem like a

3 somewhat long schedule, but there is a lot to

4 do, as you all know. And we are also working

5 right now on our particulate matter standard

6 and several of the staff working on PM are

7 also working on ozone, since we are a little

8 short handed.

9 So this is what we feel is the

10 most reasonable schedule that we can meet at

11 this point. Now onto the NAAQS review

12 process. I want to thank Chris Frey and Jon

13 Samet for their comments on this slide.

14 And Karen Martin has done her best

15 to revise it and hopefully make it clearer. 

16 And hopefully the arrows and the boxes work

17 together. And I'm just going to walk through

18 it quickly since Jon, I think you had asked

19 that we go over this.

20 So on the far upper left, we have

21 what we call our Kick Off Workshop, which is

22 something we actually did in response to
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1 recommendations from CASAC some years ago.

2 And that goes into our Integrated

3 Review Plan, where we lay out the timeline

4 and key policy relevant issues and scientific

5 questions that will govern the review ahead.

6 And you can sort of view this as

7 the workshop as being day one of what is

8 supposed to be a five year review. 

9 Obviously, the peer reviewed scientific

10 studies have happened and are ongoing during

11 these reviews.

12 The first document that comes out

13 is the Integrated Science Assessment, which

14 then feeds into the Risk and Exposure

15 Assessment. And I'll say a little more about

16 that, as will Bryan.

17 And then the last document coming

18 out of this CASAC review is the policy

19 assessment document. And the Risk and

20 Exposure Assessment is a quantitative

21 assessment as warranted.

22 And it focuses on the observations
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1 and uncertainties and it draws on the

2 Integrated Science Assessment. And I want to

3 note both the Risk and Exposure Assessment

4 and the policy assessment draw on the

5 Integrated Science Assessment.

6 We are not doing any new

7 scientific work in either of these documents.

8 We're doing analysis and policy assessment. 

9 But we are not doing new scientific work.

10 So the ISA feeds into both of

11 these documents. And as you can see on the

12 right, the yellow is the CASAC work and

13 public comment.

14 And we get CASAC review and public

15 review of all of these documents, the

16 Integrated Review Plan, the ISA, the REA and

17 the policy assessment.

18 And that all leads into the agency

19 decision making process, which we've gone

20 through before. But just briefly, we have an

21 interagency review where other federal

22 agencies review our proposal notice.
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1 We get the proposal out. There

2 are then public hearings and comments on that

3 proposal. And then we go through the agency

4 decision making process on the final rule

5 leading ultimately to the final standard.

6 So I think all the arrows and

7 boxes work together. But if anyone has any

8 questions, I would be happy to answer them. 

9 Okay.

10 Then just a brief reminder that we

11 are required to review and revise as

12 appropriate, the NAAQS and the underlying

13 science on a five year cycle with review and

14 advice from CASAC, and that different

15 considerations apply in setting the NAAQS

16 than in implementing them.

17 When we set the NAAQS, we look at

18 the health and environmental impacts, but

19 when it comes to implementation, the states

20 are very heavily involved in implementation.

21 And we and the states can account

22 for costs, technical feasibility, how much
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1 time it will take to meet the standards and

2 think about source contribution and

3 apportionment when it comes to implementing

4 the standards.

5 So there are different sets of

6 considerations that go into the establishment

7 of the standards and the implementation of

8 the standards.

9 And just a little bit more in

10 implementation, which we're obviously not

11 here to talk about today, but I just want to

12 alert folks to what comes after the standards

13 are set.

14 Some of you, I think, are aware of

15 this but it's a multi-year process to

16 actually implement these standards. And we

17 are still in the process of implementing the

18 one hour ozone standard, believe it or not,

19 and the eight hour standard that was set in

20 1997.

21 This takes a long time, despite

22 our best efforts. The first step is to
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1 designate areas as either meeting or not

2 meeting the standards, and that's done on

3 three years of air quality data.

4 And these designations occur

5 within two or three years of the issuance of

6 the final standards.

7 States are required to submit

8 state implementation plans, and those plans

9 have to include control strategies for

10 meeting the standards, and also reduce

11 contribution to any downwind non-attainment,

12 which has been a long and not very happy

13 story for EPA at this point, unfortunately.

14 But that is supposed to be

15 included in the plan that the states submit.

16 And areas, for purposes of ozone, there's a

17 very specific schedule laid out in the

18 statute as to how much time areas can have to

19 meet the standard, depending on the severity

20 of their air quality problem.

21 All standards have to be met as

22 expeditiously as practicable. But in the
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1 case of ozone, there are classifications

2 ranging from marginal up to extreme. And

3 those areas get from three to 20 years after

4 designation to meet the standard.

5 There are policies and rules in

6 place that we have right now related to

7 treatment of air quality data that are

8 influenced either by exceptional events such

9 as wildfires or stratosphere ozone

10 intrusions, and it's called the Exceptional

11 Events Rule, or the Exceptional Events Policy

12 depending on which document you're talking

13 about.

14 There's also one element of the

15 Clean Air Act designed to address

16 international transport. And that provision

17 has been interpreted a few times by EPA.

18 But it has come up more and more

19 in conversations about background and

20 concerns about the international contribution

21 to background levels.

22 So we anticipate that we'll be
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1 looking at that more in the future, as well

2 as the Exceptional Events Policy.

3 That's the end of my presentation,

4 and I just wanted to mention one other thing,

5 which I should have mentioned on the schedule

6 slide. We are in litigation right now on the

7 March 2008 ozone standard.

8 The briefs have been filed, oral

9 argument is scheduled for November 16th. And

10 so I expect sometime next spring, late next

11 winter, early spring we'll have a decision on

12 that standard.

13 So I just wanted to update folks

14 on that. So unless there are any questions,

15 I'll turn it over to Bryan. Yes, Sverre?

16 DR. VEDAL: Yes. Small point. It

17 took me a while to catch up. Just on the

18 review process again. So there's precedent

19 for CASAC being involved in that sort of

20 lower tier of boxes.

21 Is that meant to be that CASAC is

22 incorporated just in that comments box then,
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1 or you know, as any other group could comment

2 on?

3 MS. WEGMAN: Well, in the lower

4 tier of boxes, CASAC always has the option to

5 provide additional comments from a statutory

6 standpoint. We look to you for advice on

7 science and recommendations on the standards.

8 Once we propose a standard, CASAC

9 is certainly welcome to submit a comment, and

10 that has happened in the past. There is no

11 obligation for CASAC to do that. But that is

12 certainly not unprecedented. Yes, Howie?

13 DR. NEUFELD: Comment briefly on

14 what interagency review constitutes?

15 MS. WEGMAN: Yes. It's run by the

16 Office of Management and Budget. There's an

17 Executive Order, Executive Order 12866, which

18 has been in place for quite some time.

19 And that order governs any

20 significant rules that come out of the

21 federal government. So it's not just EPA, it

22 applies to all agencies in the federal
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1 government.

2 And as I say, it's run by OMB and

3 other agencies such as the Department of

4 Energy, Department of Commerce, USDA, there

5 are a number of agencies who might be

6 interested in a national ambient air quality

7 standard.

8 They're brought together by the

9 Office of Management and Budget. The

10 Executive Order permits up to a 90 day review

11 period for both a proposal and a final rule.

12 So it could be up to six month

13 period for review by the interagency process

14 because we have court ordered deadlines. 

15 Often, those reviews are much shorter,

16 sometimes they're longer.

17 And then we get comments from the

18 agencies. Anything that we send over in

19 writing or anything that is sent back to us

20 in writing goes into the docket for the

21 rulemaking.

22 So the public can see what kind of
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1 review process has occurred and what kind of

2 comments we've gotten from the other

3 agencies. And the Administrator would

4 normally not issue any rule until that

5 interagency review process was complete. 

6 Okay, great, thank you.

7 DR. HUBBELL: Okay, so as Lydia

8 mentioned, originally Dr. Karen Martin was

9 going to provide this brief overview of the

10 policy assessment and the risk assessment. 

11 And she's unfortunately out sick.

12 So I will be covering for her, and

13 hopefully I'll be able to channel her

14 knowledge into this discussion.

15 MS. WEGMAN: Do we have his

16 presentation? You can keep talking.

17 DR. HUBBELL: Okay, all right,

18 we'll keep talking. I don't have any

19 pictures or anything, so we'll be all right.

20 So you know, the title of this was

21 overview of the first drafts of the Risk and

22 Exposure Assessment and policy assessment. 
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1 It's not really an overview as much as a

2 short discussion of some key points.

3 The first thing we wanted to talk

4 about was trying to clarify a little bit. 

5 And I think the need for this was clear this

6 morning, as well. What are the roles of the

7 Risk and Exposure Assessments and the policy

8 assessments in the review of the Ozone NAAQS

9 compared to the ISA.

10 Certainly both documents, the REA

11 and the policy assessment, you know, both

12 documents draw from the Integrative Science

13 Assessment.

14 One point we wanted to make clear

15 is that they do not independently review the

16 conclusions that are reached in the ISA. So

17 they're entirely based on the science that's

18 presented in the ISA. 

19 Further, the ISA doesn't really

20 prescribe what we will do with that

21 scientific information in the REA or the

22 policy assessment. Those are judgements that
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1 are made independent from the information

2 that's provided in the ISA.

3 So our job is to take the

4 information from the ISA and interpret it and

5 provide Quantitative Risk Assessments. And

6 then interpret the evidence and the

7 Quantitative Risk Assessment information in

8 the policy assessment.

9 The Risk Assessment focuses on

10 identifying appropriate set of studies. And

11 by appropriate, this means with good

12 scientific backing and also with data

13 suitable for a quantitative risk assessment.

14 So we focus on an appropriate set

15 of studies that provide concentration or

16 exposure response functions, and other types

17 of information such as information on the

18 definition of the health effect and

19 sufficient level that we can give baseline

20 incidents data, for example.

21 And those are things that are

22 necessary to provide a quantitative analyses.
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1 The intent of the Quantitative Analysis is to

2 characterize estimates of exposures and risks

3 including uncertainties and confidence that

4 we have in the results.

5 It's not intended to address the

6 policy implications of the results. That's

7 what the policy assessment moves towards.

8 And the final policy assessment

9 integrates and interprets information from

10 both the ISA and from the REAs, that's both

11 the Health and Welfare REAs to frame the

12 broadest range of policy options that could

13 be supported by the available scientific

14 evidence and assessments, quantitative risk

15 assessments and other types of assessments,

16 air quality assessments, for consideration by

17 the Administrator.

18 These documents are intended to

19 facilitate CASAC's advice and recommendations

20 on any new standards or revisions to existing

21 standards as may be appropriate.

22 It's also intended to facilitate
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1 public comment on the standards and allow for

2 that type of input to our decision making.

3 So the next couple of slides, I

4 want to talk about a couple of overarching

5 issues that we've identified that cross

6 between the policy assessment and the risk

7 assessment.

8 We've provided a number of charge

9 questions, very specific charge questions on

10 the REA and on the policy assessment that

11 cover a broad range of issues regarding a

12 number of different aspects of the

13 Quantitative Risk Assessments.

14 But these particular issues I'm

15 getting ready to tee up are issues that we

16 would really like to listen to your comment

17 on there.

18 They're very influential issues

19 and they're broad context issues for how we

20 conduct our Risk Assessment and our policy

21 assessment.

22 The first of these is the issue of
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1 how to interpret the epidemiological

2 evidence. Our risk and exposure assessments

3 rely heavily on the epidemiological evidence

4 in the literature for at least part of the

5 analysis.

6 We also have an exposure and

7 clinical risk analysis that depends on that

8 body of evidence. But we have a lot of

9 epidemiological evidence that we use in

10 generating our quantitative risk assessments.

11 One of the most important of the

12 issues that comes up is that in the ISA,

13 there's a conclusion that there's a lack of a

14 discernible threshold in the ozone

15 concentration response functions.

16 Because of this, there's more

17 emphasis, then, placed on the information

18 provided in the ISA regarding decreased

19 confidence in the shape and magnitude of

20 responses at very low ozone concentrations,

21 well below the current standard.

22 And this is something that's
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1 actually salient for all different NAAQS

2 reviews that we have underway.

3 As we've gotten lower or improved

4 air quality throughout the country, we're now

5 at a situation where we're asked to provide

6 risk estimates looking at improvements in air

7 quality at very low concentrations.

8 So this is a really important

9 issue that we've been wrestling with and

10 trying to determine the best way to deal with

11 this in our quantitative risk assessments.

12 So one of the questions is how to

13 appropriately reflect this consideration for

14 a no threshold function in the risk

15 assessment in presenting the risk results

16 over the full range of ozone concentrations.

17 And you'll see that in our

18 document that we've tried to address

19 different ways of presenting that

20 information. And also, at the same time, how

21 best to characterize the confidence we have

22 in those risk estimates while reflecting the
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1 ISA conclusion that the best supporters were

2 a linear and no threshold function.

3 In addition, we have to think

4 about how to appropriately reflect this

5 consideration in the policy assessment in

6 translating air quality information from the

7 epi studies into the basis for reaching

8 conclusions on potential alternative

9 standards.

10 As a starting point for this

11 process, in the first draft policy

12 assessment, we've looked at distributional

13 air quality statistics for two studies as

14 examples to raise questions about how to

15 apply these statistics. And we're, again,

16 looking for CASAC advice on these issues.

17 So the next overarching issue that

18 I wanted to bring up is, of course,

19 background ozone concentrations, of which

20 we've heard a great deal this morning.

21 Clearly, as Lydia mentioned in her

22 remarks, background concentrations are very
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1 relevant in implementing the standards

2 because we need to understand the sources of

3 ozone that are coming into the U.S.

4 But our goal in thinking about

5 setting the standards and in reviewing the

6 evidence is to look more fully at the full

7 characterization of air quality and what

8 contributes to air quality rather than

9 focusing on a limited definition of

10 background ozone associated with a particular

11 characterization such as North American

12 background.

13 This issue is somewhat unique to

14 the ozone standards review because of the

15 relatively larger role of background ozone.

16 But in setting the standards, case

17 law makes it very clear that attainability

18 and technological feasability are not

19 relevant considerations. And thus,

20 background ozone is not a bright line

21 constraint in setting the National Ambient

22 Air Quality Standards.
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1 This is discussed in the policy

2 assessment, the legal considerations are

3 discussed in the policy assessment, but it's

4 still an issue that is being discussed and

5 evaluated.

6 So important considerations are

7 how do we appropriately take background into

8 account in estimating risks? In the past

9 reviews, we've estimated risks in excess of

10 an EPA defined policy relevant background.

11 And let me note that policy

12 relevant background was intended to reflect,

13 at the time, more generally controllable

14 emissions in the face of relatively simple

15 characterizations of background ozone.

16 The choice of defining PRV was a

17 policy choice rather than a science

18 interpretation.

19 However, in recent years, more

20 sophisticated modeling has become available,

21 and this allows us to begin providing a more

22 refined understanding of the temporal and
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1 spatial nature of background ozone, and

2 consequently, more fully characterize ozone

3 air quality, and what contributes to that air

4 quality with a view towards providing

5 information that can inform both the NAAQS

6 process, but also help to inform other

7 policies that might address things such as

8 international contributions.

9 In our current review, we focus

10 more on estimating total risks as

11 comprehensively as possible, regardless of

12 the source of the ozone.

13 And this is to address one of the

14 most critical questions in the policy

15 assessment, in the first draft policy

16 assessment which is what is the adequacy of

17 the current standard?

18 In order to understand that, we

19 need to understand the risks that is faced by

20 populations exposed to the amount of ozone in

21 the atmosphere, rather than looking just at

22 the ozone that's associated with U.S.
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1 emissions.

2 However, we do account for U.S.

3 background, the contribution of U.S.

4 emissions in simulating just meeting the

5 current standards. And that allows us to

6 focus on the impact of U.S. emissions, or the

7 controllable emissions.

8 In both past and current reviews,

9 we've given more consideration to changes

10 between alternative standards because we have

11 more confidence in those estimates of

12 reductions in the risk across alternative

13 standards because those reductions in risk

14 are not sensitive to the uncertainties that

15 are associated with background ozone, or

16 referring back to the previous slide, in

17 applying response functions down to very low

18 levels.

19 And again, this is addressing the

20 second major question in the next draft of

21 the policy assessment, which is what are the

22 impacts of achieving alternative standards
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1 relative to the current standard?

2 So these considerations are

3 becoming even more important as we move to

4 the second draft.

5 And finally, we need to consider

6 how to appropriately take background ozone

7 into account in the policy assessment.

8 And the background ozone

9 information that's provided currently, in the

10 current draft of the policy assessment is

11 intended to provide context for understanding

12 implications of potential alternative

13 standards to begin the process of

14 understanding what are the concentrations of

15 background ozone throughout the country in

16 different locations, in urban areas versus

17 rural areas, in elevated locations versus low

18 level locations?

19 The emphasis of this is really to

20 start thinking about how to begin thinking

21 about implementation issues associated with

22 policies that are intended to attain NAAQS
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1 that may be closer to background levels.

2 Whether background ozone should be

3 given any consideration beyond implementation

4 in assessing lower standard levels, as the

5 scientific evidence and the analyses that we

6 have, risk analyses and air quality analyses

7 become increasingly uncertain as we move to

8 lower levels, this is a matter of further

9 discussion in the second draft ISA, I'm

10 sorry. Second draft policy assessment, pardon

11 me. I'm getting my documents messed up.

12 In the second draft policy

13 assessment, and this will include both legal

14 and policy considerations associated with

15 considering background ozone.

16 Again, we continue to wrestle with

17 the issue of contributions to both air

18 quality and risk. And one of the issues

19 that Daniel Jacobs mentioned and that we're

20 continuing to wrestle with is the difference

21 between contributions to air quality given

22 the current levels of ozone versus
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1 counterfactuals where we're looking at what

2 is the air quality levels or the risk above

3 defined background levels.

4 And again, those are very

5 important distinctions. And Daniel expressed

6 his opinion this morning about the

7 difficulties in dealing with contribution of

8 ozone.

9 But when we're wrestling with what

10 are the most important policy questions, we

11 still have not been able to fully wrap our

12 minds around whether we're most interested in

13 contribution of different sources to existing

14 risk in air quality, or whether we're wanting

15 to focus on risk and air quality above these

16 artificially defined background levels.

17 So that's all I have and I can

18 take some questions.

19 CHAIR SAMET: Sverre?

20 DR. VEDAL: Yes.

21 CHAIR SAMET: You're not

22 forgotten. How can I do that?
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1 DR. VEDAL: Just a point of

2 clarification. Bullet three of bullet three,

3 how does that take account of background?

4 DR. HUBBELL: Which one? Oh, the

5 accounting for U.S. background and civilian

6 just meeting the standards?

7 DR. VEDAL: Yes.

8 DR. HUBBELL: Well, what we do is

9 when we're simulating, and in this case in

10 the rollback technique that we've used, we've

11 estimated U.S. background levels, meaning

12 what the air quality would be in the absence

13 of U.S. emissions.

14 And we've used that as a floor. 

15 So you can't roll back the air quality values

16 on any particular hour below the background

17 levels. And that's how it's accounting for

18 that.

19 So the only thing you're seeing in

20 the adjustments to the risk estimates is the

21 effect of U.S. emissions, or reducing U.S.

22 emissions.
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1 DR. VEDAL: It's not the North

2 American factor?

3 DR. HUBBELL: No, that is U.S. In

4 our particular first draft, it's focusing on

5 U.S. emissions. Again, this is beginning to

6 look at simulating just meeting the current

7 standards.

8 And the idea was to focus first on

9 U.S. emissions in doing that. If we had not

10 been able to achieve that, we might have been

11 able to consider going beyond that to the

12 other potential sources.

13 CHAIR SAMET: Fred?

14 DR. MILLER: So are you saying

15 that for estimating the controllable risks

16 that you can have some impact on by a

17 standard, that you're incorporating

18 background levels so that the Administrator

19 has a judgement to say that instead of going

20 from zero to the level which is 729 people

21 dead, that it is going from U.S. background

22 level, it's 115 that I can control, or what?
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1 My point is I think that the

2 agency has misinterpreted the CASAC's

3 recommendations earlier about policy relevant

4 background, and I'll expand on that.

5 But are you claiming that the

6 Administrator will have a viable assessment

7 of the controllable portion of risk by the

8 analyses that you're doing now in just

9 rolling back the standards and not

10 incorporating excess above policy relevant

11 background?

12 For example, you have computed

13 risks here above the LML. Okay, the LML is

14 for a factor of four to five below policy

15 relevant background and yet you're adding up

16 those deaths and you're adding up those

17 asthma attacks and so on.

18 I totally do not buy that, and I'm

19 trying to understand how you can say that the

20 Administrator is able to adequately

21 understand what portion of the risk of

22 different health pinpoints is controllable by
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1 the standard level that they choose to set.

2 I do not see where your current

3 procedure ignoring PRB does that.

4 DR. HUBBELL: Well, I mean, the

5 decision we made for this first draft, and

6 again, we're looking for your comment on this

7 so obviously we appreciate the comments. Yes

8 --

9 MS. WEGMAN: We noticed.

10 DR. HUBBELL: We noticed, yes. 

11 But the current approach is to recognize that

12 ozone is ozone and to recognize that we

13 needed a full description of risk to be able

14 to understand the contributions of meeting

15 alternative standards to reducing that risk.

16 The question of whether or not we

17 also need an estimate of risk above various

18 different definitions of background is one

19 that we're in the process of discussing.

20 And again, that's what we're

21 looking for comment on. But our

22 interpretation at this point is that you
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1 know, based on the ISA, risks go all the way

2 down to very low levels.

3 And as such, it was appropriate to

4 provide a full estimate of risk to understand

5 what the impact on that total risk is of

6 moving to different alternative standards.

7 DR. MILLER: But you didn't answer

8 my question. I asked you if what you're

9 saying now in terms of the way you're

10 estimating risk that the Administrator can

11 understand what is the amount of that risk

12 that's controllable by an alternative

13 standard that they set? You didn't answer

14 that question.

15 MS. WEGMAN: We haven't made that

16 judgement yet. What we're trying to do is

17 figure out how we should move from this first

18 draft policy assessment where we took the

19 approach that Bryan described and which we'll

20 describe a little more fully and on which we

21 look forward to your comments, and what we

22 should do for the second draft policy
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1 assessment.

2 We're trying to figure out what is

3 the best set of information to present to the

4 Administrator.

5 DR. MILLER: Okay.

6 MS. WEGMAN: We haven't made that

7 judgement yet.

8 DR. MILLER: All right. And I

9 maintain, you cannot do your job without

10 considering PRB. And I'll say it again, and

11 I'll say it again until you get it.

12 CHAIR SAMET: Okay, so we will

13 come back to this, I'm sure. Something new,

14 Sverre?

15 DR. VEDAL: Well, I just want to,

16 with trepidation, disagree with Fred. I

17 mean, I thought --

18 CHAIR SAMET: Okay. No point in

19 disagreeing with each other, yet. Daniel?

20 DR. JACOB: Yes, I want to talk on

21 Bryan's statement of a quandary about how to

22 quantify the contribution from background
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1 ozone because I don't really understand that

2 quandary except perhaps, if you want to

3 understand how the effect of background ozone

4 changes with the total ozone levels.

5 The point, give me a chance to

6 follow up and then, the point that, okay, if

7 you're trying to tag ozone molecules in a

8 given air parcel in terms of a contribution

9 from background versus domestic pollution or

10 whatever, first of all, it's not possible.

11 Second, what would you gain

12 because it doesn't respond to any kind of

13 question about the benefit of an emission

14 control strategy, all right, because if you

15 control the emissions, when you're relative

16 abundances of these different flavors of

17 ozone would change.

18 So I'm just curious, why is it

19 that you want to label ozone molecules as

20 background in terms of contributions to total

21 ozone?

22 CHAIR SAMET: Bryan, why don't you
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1 answer quick because I just think this is one 

2 of the issues that's before us these next two

3 days.

4 DR. JACOB: Right. We can defer

5 that if you want.

6 CHAIR SAMET: I mean, I think it's

7 one of the big questions on the table, and I

8 think let's go through the documents. And

9 this is just going to come up over and over

10 again.

11 I do have one question that I

12 think that both to Lydia and Bryan. I mean,

13 it seems to me that looking at the schedule,

14 the process that you've outlined, the

15 iterative interaction between the REA and the

16 PA, I can understand why you may have

17 advanced the schedule as it is, but does this

18 bear any relationship to what reality is

19 likely to be?

20 And I mean, I just see that with

21 where you are, what you say is to be done,

22 that the proposed schedule seems to me quite
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1 optimistic if unrealistic.

2 MS. WEGMAN: Well, I will observe

3 that we originally hoped to have the second

4 drafts done by January of this coming year,

5 2013. And we have now changed that to late

6 winter to give ourselves probably at least

7 another six weeks to complete the documents.

8 We agree with you that it is a

9 schedule that will require a lot of work on

10 our part. And we are prepared to put that

11 work into it.

12 One thing I will observe is that

13 we do have a statutory mandate for a five

14 year review. And the last time we completed

15 that review was March of 2008. And so that

16 would bring us to March of 2013 for five

17 years.

18 We clearly have no expectation of

19 meeting that date for a final standard, but

20 we are doing everything we can to move

21 forward. And we are obviously waiting to hear

22 your advice over the next three days to make
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1 a determination whether we can meet this

2 schedule. But this is our goal.

3 CHAIR SAMET: And I think it's

4 important to point out that you only include

5 one additional CASAC review, which again, in

6 terms of the amount of new material that it

7 would appear would come to the next meeting,

8 may not be truly necessarily workable.

9 I mean, it's hard to anticipate,

10 but it sounds to me like with so much to be

11 done, that to say there might only be one

12 further review may also not work.

13 I mean, again, I'm just pointing

14 this out. There's probably no point in

15 furthering the discussion. But I think, you

16 know, we can circle back to this on Thursday,

17 perhaps.

18 It just seems to me that the

19 schedule has clear problems. And I think we

20 all understand why you wanted to meet it.

21 MS. WEGMAN: Yes, and we'll take

22 your comments into account and we certainly,
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1 you know, hope to get your thoughts on

2 Thursday again about the schedule and whether

3 or not another review would be needed.

4 But I just want to make sure you

5 understand why we have this schedule the way

6 we do, as it is now.

7 CHAIR SAMET: Okay, sure, sure. 

8 Dave?

9 MR. ALLEN: I have a quick

10 question. To what extent do these two

11 documents, since this is the overview that

12 you're presenting, to what extent do they

13 have to be stand alone documents that is

14 requiring the enormous amount of redundancy?

15 And is it a reasonable

16 recommendation that we remove some of that to

17 make these things readable and accessible?

18 MS. WEGMAN: Yes, we actually

19 would like your advice on that. We flagged a

20 couple of questions about some of the

21 chapters in the policy assessment, which

22 referred back to the risk and exposure
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1 assessment and did we need that chapter.

2 And we got some initial comments

3 on that. We want to reduce redundancy. 

4 We're not committed in any way to having the

5 documents be redundant. But we want to make

6 sure we're fully covering the things we need

7 to cover.

8 MR. ALLEN: Yes, but the key

9 question is do they have to be stand alone,

10 you know, for a reader that's not familiar

11 with the preceding? 

12 MS. WEGMAN: There's certainly no

13 legal obligation to have these documents at

14 all, but let alone have them be stand alone

15 documents.

16 Frankly, they're both pretty

17 massive undertakings. And for purposes of

18 comprehensibility, it seemed to make sense to

19 have them as two documents.

20 But we can certainly consider

21 whether that's the best way to move forward

22 on them. I mean, that's something we're open
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1 to.

2 MR. ALLEN: Thank you.

3 DR. NEUFELD: Just a quick follow

4 up on your comment, Jon. And if you look at

5 the diagram of this page here where CASAC has

6 input down to the policy assessment, but then

7 you look at the anticipated schedule, there's

8 no meeting of CASAC to comment on the final

9 PA.

10 MS. WEGMAN: And actually, we

11 don't normally have meetings with CASAC to

12 comment on the final PA. The way we normally

13 do it, which is the same with the ISA.

14 You've seen the third draft now. 

15 We wouldn't anticipate a meeting to comment

16 on the final ISA. CASAC is always free to

17 offer comments. But we do not normally have

18 a meeting to get comments on the final PA.

19 CHAIR SAMET: Okay, well why don't

20 we move on to the rest of your presentation.

21 MS. WEGMAN: Okay, is that what

22 we're doing next? Okay. I wasn't sure
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1 whether we were doing public comments next or

2 not.

3 CHAIR SAMET: Well, let's see.

4 MS. WEGMAN: We can do it either

5 way.

6 CHAIR SAMET: Well, actually the

7 way we have this scheduled, I think we would

8 go on and continue to hear from EPA, right?

9 DR. NUGENT: Right, right. But we

10 do have a public commenter participating by

11 phone who's not in the room.

12 DR. FREY: Can I just ask a

13 clarifying question while you're sorting that

14 out? Lydia, on the agency decision making

15 and draft proposal notice, is that what's

16 otherwise known as the advance notice of

17 proposed rule? Or that's something

18 different?

19 MS. WEGMAN: No, advanced notice

20 of proposed rulemaking is a different

21 document. And we're not planning for one of

22 those yet. Yes, that's just the proposed
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1 rule, what we would otherwise call the

2 proposed rule.

3 CHAIR SAMET: Let me ask, just in

4 terms of getting organized, how long will the

5 remainder of your presentation take?

6 MS. WEGMAN: What do you think? 

7 How long will the remainder take?

8 DR. HUBBELL: It should take about

9 30 minutes.

10 CHAIR SAMET: About 30 minutes.

11 MS. WEGMAN: Vanessa's worried

12 about time. Can you shorten things?

13 DR. HUBBELL: We can shorten

14 things as needed.

15 MS. WEGMAN: Should we try to move

16 more quickly? I know we have a lot of public

17 commenters.

18 CHAIR SAMET: Yes, we've taken

19 some time, I think, in sort of high level

20 discussion. But if you could get through it,

21 perhaps, in 15, 20 minutes and then we'll

22 move directly to the public comments.
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1 MS. WEGMAN: Okay, who's first? 

2 Karen?

3 DR. HUBBELL: Yes, let me mention

4 that they'll be three speakers because this

5 is a highly multi-disciplinary product. We

6 have someone talking about air quality and

7 then someone talking about exposure in

8 clinical risk followed up by discussion of

9 epidemiological risk.

10 DR. MILLER: While you're

11 shifting, I just want to say I know you get

12 it, but I just wonder how the Administrator

13 gets it.

14 DR. HUBBELL: That's a rhetorical

15 question. 

16 MS. WEGMAN: We know. That's how

17 we took it.

18 (Off microphone discussion)

19 CHAIR SAMET: So let's aim to be

20 done by quarter of three with your --

21 MS. WESSON: All right. So I

22 guess we'll go ahead and try to get started.
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1 Hopefully the slides will come up. So we're

2 going to start by giving a brief overview of

3 the first draft of the Health REA.

4 Okay, so this slide, I just wanted

5 to start by recognizing that there was a

6 whole group of people who worked very hard on

7 this document to make it possible.

8 This slide lays out all the

9 chapters in the health REA. And these are

10 the chapters that we'll be discussing this

11 afternoon and also tomorrow morning.

12 I'm going to cover some slides

13 that give a brief overview of Chapter 4, and

14 then turn it over to John Langstaff, he'll

15 discuss Chapters 5 and 6. And then to Zach

16 Pekar, he's going to go over Chapters 7 and

17 8.

18 So, air quality considerations. 

19 For the risk and exposure assessment, we

20 focused on several urban case study areas. 

21 For these areas, there was 12 in the first

22 draft of the REA.
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1 We used five years of air quality

2 data, 2006 to 2010. We separated these five

3 years of data into two three year design year

4 periods, 2006 to 2008 and 2008 to 2010.

5 And one of the questions that we

6 posed to CASAC is whether they think that

7 this time period is adequate for our

8 assessments.

9 So using this time period for the

10 first draft, we simulated current ozone

11 concentrations and used current air quality

12 concentrations and simulated just meeting the

13 current standard of 75 ppb.

14 We did this for the 12 case study

15 areas. And for the second draft, we will

16 also look at alternative standard levels.

17 So for the first draft, in

18 simulating just meeting the current standard,

19 we used the quadratic rollback approach. And

20 as Bryan mentioned, this approach rolls back

21 air quality and it looks at a lower bound

22 concentration to make sure that we never roll
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1 back past that concentration.

2 And in this first draft, we've

3 used U.S. background concentrations to make

4 sure that we don't decrease air quality on an

5 hourly basis past that concentration.

6 So another question that we posed

7 to CASAC is our proposal to use the CMAQ

8 Higher Order Direct Decoupled Method or HDDM

9 information to do rollback in the second

10 draft.

11 We would use this for simulating

12 just meeting the current standard as well as

13 alternative standard levels. And we believe

14 that this method allows us to better simulate

15 how monitors would respond to NOx and VOC

16 emissions reductions more realistically than

17 the statistical approach in the quadratic

18 rollback method.

19 So in the first draft REA, we

20 focused on 12 studies for the urban area risk

21 assessment. These studies are shown in blue

22 and red.
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1 For the second draft REA, we

2 propose to use 16 areas for the exposure

3 assessment. For this first draft, we focused

4 on four areas, and these are shown in the

5 blue circles.

6 These areas were selected based on

7 certain selection criteria. We looked at

8 ozone concentrations between 2006 and 2010

9 and chose areas that were meeting or above

10 the current standard level.

11 We also looked at availability of

12 data such as the health study data, baseline

13 health incidents data and air conditioning

14 prevalence.

15 We also wanted to assure adequate

16 inclusion of sensitive populations and

17 geographical heterogeneity.

18 So this slide is meant to give a

19 little bit more information on the quadratic

20 rollback approach that we applied in the

21 first draft.

22 The plot that you see on the left
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1 is a Box and Whisker plot and it shows the

2 distribution of U.S. background values that

3 we used in the quadratic rollback approach

4 for the lower bounds.

5 These were calculated as monthly

6 average diurnal profiles of U.S. background

7 and they were calculated for each of the 12

8 urban areas.

9 And these values, as you can see

10 from the plot, they vary from area to area. 

11 But in general, the concentrations are near

12 zero, which usually occur in the early

13 morning and nighttime.

14 And they range up to 30 to 40 ppb,

15 which usually happens in the mid afternoon. 

16 And the medium values are between 10 to 20

17 ppb.

18 And when we apply the quadratic

19 rollback approach, we simulate moving air

20 quality down and we check to make sure that

21 we don't go past U.S. background.

22 If we do, we roll those air
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1 quality value hours up. When we applied this

2 in the first draft, we found that we did not

3 need to make many adjustments, and when we

4 did, they were very small, usually around 0.2

5 ppb. And even the largest adjustment that we

6 had to apply was less than 5 ppb.

7 So as I mentioned, for the second

8 draft, we proposed moving to a modeled based 

9 adjustment approach using the CMAQ HDDM. We

10 believe this approach will allow us to better

11 address the various chemical conditions

12 across an urban area and simulate better how

13 different monitors respond to different

14 emissions reductions.

15 This will also allow us to more

16 realistically simulate the diurnal changes in

17 ozone concentrations. And take into account

18 that ozone concentrations can both increase

19 and decrease with emissions reductions.

20 So the figure that you see on the

21 right is from the Simon et al technical memo.

22 And it shows the distribution of hourly ozone
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1 values averaged across 10 Atlanta area

2 monitoring sites.

3 And it compares the air quality

4 observations to simulating just meeting the

5 current standard using the model based

6 adjustment approach and the quadratic

7 rollback approach.

8 And what we found in the case

9 study example in Atlanta was that ozone in

10 the urban core is less sensitive to NOx

11 emissions reductions than ozone monitors on

12 the outskirts of the city.

13 And what this had the impact of

14 resulting in when comparing the HDDM to the

15 quadratic approach was that the HDDM

16 adjustment shows the 25th, 50th and 75th and

17 95th percentiles much lower than the

18 quadratic rollback approach did.

19 However, when you look at the

20 outliers, which are shown in the circles

21 here, these are above the 95th percentile,

22 when you look at those values, the quadratic
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1 rollback approach actually had the impact of

2 shifting those lower than the HDDM

3 adjustment.

4 And we think this has to with the

5 sensitivity of the monitors to the different

6 emissions reductions, which the quadratic

7 rollback approach doesn't take into account.

8 So in addition to doing our urban

9 case study analysis, we also looked at a

10 national scale risk assessment. We focused

11 on the years of 2006 to 2008.

12 We used ozone measurements, and we

13 fused those with 2007 CMAQ modeling data. We

14 did this using the enhanced Voronoi Neighbor

15 Average or eVNA technique.

16 This technique uses the

17 measurements as the absolute ozone

18 concentrations. And then it uses the modeled

19 concentrations to predict the gradients

20 between the monitors.

21 And we created two fuse surfaces.

22 One for the seasonal average eight hour daily
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1 max metric, and this is consistent with the

2 metric used in the Bell et al study in 2004.

3 And one thing I want to point out

4 is that what we did, we created the surface

5 for the ozone season. The first draft REA

6 labels this as May through September.

7 And that's actually incorrect. We

8 did it for the ozone season. For the second

9 draft, we want to go back and do it for the

10 May to September period.

11 The other fuse surface that we

12 created was for the seasonal average eight

13 hour daily mean metric. And this is

14 consistent with the metric used by Zanobetti

15 and Schwartz, 2008. And this is an average

16 from June to August, 10:00 a.m. to 6:00 p.m.

17 This slide shows those air quality

18 surfaces for the two metrics I just

19 mentioned. The upper left shows the seasonal

20 average eight hour daily maximum, and the

21 lower right shows the seasonal average eight

22 hour daily mean.
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1 You can see the higher

2 concentrations in the urban areas, especially

3 in the lower right figure and in the east. 

4 In the west you can see higher

5 concentrations, especially in California and

6 in Idaho from the fires that occurred in 2006

7 to 2008.

8 And one thing I wanted to mention

9 because of some of the comments, you see

10 lower ozone concentrations in the seasonal

11 average eight hour daily maximum.

12 And part of that has to do with

13 the fact that we were using the seasonal

14 average versus the May through September

15 average. And for example, in California, we

16 would be using the whole year of ozone data,

17 which would give you much lower

18 concentrations than using the May through

19 September period.

20 With that, I can stop and take

21 some questions before I turn it over to John

22 Langstaff.
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1 (Off microphone discussion)

2 CHAIR SAMET: Don't stop, we might

3 ask questions.

4 MR. LANGSTAFF: Okay.

5 CHAIR SAMET: Let's keep going and

6 go through the whole thing.

7 MS. WEGMAN: Just keep going.

8 MR. LANGSTAFF: So we've done an

9 assessment of population exposure to ozone

10 very focused on children because they spend a

11 fair amount of time exercising outdoors.

12 We've looked at the number of

13 people that experience eight hour abject

14 exposures above three benchmark levels, 0.06,

15 0.07, 0.08 ppm.

16 In the second draft, we'll be

17 looking also assessing exposure to people

18 older than 65 and outdoor workers, and also

19 increasing the number of urban areas from

20 four to 16.

21 We're using the apex exposure

22 model, which we've used in previous reviews.
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1 It's been used since the '90s and been under

2 development since then.

3 And it simulates movement of

4 people through their daily activities and so

5 on and their exposure to pollutants. And

6 it's a probabilistic model, so it captures

7 most of the variability in population

8 exposures, but not uncertainty.

9 We're doing a couple of new

10 analyses to the exposure assessment. One is

11 evaluating attributes in most exposure in

12 highest risk populations.

13 And it comes as no surprise that

14 those are the primary factors there are the

15 level of outdoor ozone, time spent outdoors

16 and the level of exercise.

17 We're also going to have done a

18 qualitative analysis, the effective air

19 quality index on exposures. It's referred to

20 as averting behavior.

21 And we find that in response to

22 air quality alerts, about 30 percent of
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1 asthmatics reduced their outdoor activity

2 level time, and about 15 percent for the

3 total population. And typical time reduced

4 outdoors was 20 to 40 minutes.

5 We're doing a qualitative

6 characterization on uncertainty where we've

7 viewed the uncertainty characterizations and

8 previous NAAQS reviews.

9 And the result of this is we find

10 that the three important elements that

11 contribute to uncertainty are the time

12 activity patterns, spatial variability, and

13 ozone concentrations, especially near roads,

14 and the physiological model for estimating

15 ventilation rates, which is more important

16 for the risk than the exposure.

17 As in previous reviews, we're

18 doing a lung function risk assessment where

19 we're looking at lung function capacity

20 measured in forced expiratory volume in one

21 second, and looking at the number of people

22 that experienced decrements in FEV1 of
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1 greater than 10, 15 and 20 percent.

2 We're doing this in two ways, both

3 of these methods are based on controlled

4 human exposure studies.

5 The primary method is based on

6 population exposure response curves based on

7 analysis of data from several 6.6 hour

8 clinical studies where the FEV measurements

9 are made at the beginning and end of these

10 exposures and corrected for the effect of

11 exercise and clean air.

12 And these studies have had

13 exposure levels ranging from 0.04 to 0.12

14 ppm. And then exposure distributions from the

15 APEX model are combined with these exposure

16 response curves to estimate the population at

17 risk for FEV decrements greater than these

18 three levels.

19 And we are updating those exposure

20 response curves with data from additional 6.6

21 hour studies. And those results will be in

22 the second draft REA.
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1 The new model we're using is by

2 McDonnell, Stewart and Smith. And the

3 advantage of this model is it can predict

4 lung function decrements for any pattern of

5 exposure and exercise and not just the 6.6

6 hour of moderate exercise patterns.

7 So for example, it can predict risk for

8 kids exercising after school for a shorter

9 period of time. This approach also allowed

10 us to evaluate the distribution of risk

11 across modeled individuals and characterize

12 risk to the groups at highest risk.

13 And this model predicts FEV1 for

14 individuals based on their ages, heights,

15 weights, time course of ventilation rates and

16 ozone exposures.

17 And it's based on 15 EPA studies

18 which studied adults ranging from age 18 to

19 35, from exposures ranging from 0.08 to 0.4

20 ppm. We are updating this model with data

21 from recent lower ozone studies.

22 And those results will also be in
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1 the second draft risk and exposure

2 assessment. There was a couple of issues with

3 this model. One is the extensions to ages

4 younger than 18 and greater than 35.

5 And the other is the uncertainty

6 for population not represented by the data as

7 unknown, for example, asthmatic children.

8 Here's an example of comparing the

9 two methods, the primary method and the

10 McDonnell, Stewart, Smith model for one

11 current standard scenario.

12 And we find that for children,

13 this is for children ages 5 to 18, that the

14 new method predicts risk much higher than the

15 primary method we're using.

16 If we compare adults age 18 to 35,

17 the differences are much less. And I'll turn

18 it over to Zach.

19 DR. PEKAR: And how much time do I

20 have, just to get a sense for it. Like, five

21 minutes?

22 CHAIR SAMET: Five, six to seven.
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1 DR. PEKAR: Give me the one minute

2 warning in a second here. Okay, so I was

3 going to talk about the epidemiology based

4 risk assessments.

5 By that, I mean risk assessments

6 obviously based on concentration response

7 functions, excuse me, using CR functions that

8 are based on epi studies.

9 And there are two components to

10 this risk assessment that we completed. 

11 There's an urban study area analysis, which I

12 think is what most of you are familiar with

13 in this type of review.

14 And that's an analysis where we

15 focused on deriving high confidence

16 assessments for a set of urban study areas. 

17 And that analysis, in this case, for this

18 first draft was modeled for the current

19 conditions scenario, and also for simulated

20 attainment of the current standard.

21 For the next version of the

22 analysis, that's where we'll look at the
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1 alternative standard levels.

2 We also, for the first time,

3 included a national scale analysis. And that

4 analysis was intended to look at the

5 generalized mortality effect of ozone within

6 the U.S.

7 And that focuses on a current

8 conditions scenario. And we also, as part of

9 that national scale analysis and part of our

10 reason for doing that was we conducted a

11 representativeness analysis of the 12 urban

12 study areas by looking at how well those

13 study areas that were evaluated for the urban

14 study area analysis covered key risk factors

15 associated with ozone exposure and risk.

16 So we could use the national scale

17 analysis and specifically parameters

18 associated with that kind of analysis to look

19 at how well our study areas covered

20 distributions of those parameters within the

21 country in general.

22 So this study, I mean this slide
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1 looks at the urban study area analysis and

2 looks at critical elements of that analysis.

3 And I'm just going to touch very quickly on a

4 couple of these elements.

5 In the past, we've used a 24 hour

6 metric, actually, as the metric to model

7 using these CR functions. In this case, we

8 looked at shorter peak metrics based on

9 review of the evidence and ISA.

10 And so we focused primarily on

11 eight hour max and mean metrics, and used one

12 hour max metrics sort of sparingly, also. 

13 I'll kind of move through some of this other

14 stuff, which I think people are familiar

15 with.

16 The other point that we made is

17 that we did model background with rollback

18 using the U.S. floor as a boundary for the

19 hour monitor level hourly measurements.

20 We wouldn't let that go below

21 that. And I think one point to emphasize

22 that Karen made is in simulating the current
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1 standard, what Karen was saying is that we

2 actually didn't hit that floor, virtually at

3 all.

4 So at least for the current

5 standard, we could attain that without

6 clipping any of the mortality that would have

7 occurred if we had just done rollback without

8 that floor.

9 Obviously, we haven't run the

10 current or alternate standard levels, but for

11 the current standard, that was the case. And

12 we also used an LML.

13 We modeled risk down to zero and

14 also down to the lowest measured level

15 obtained from the epidemiology studies that

16 we used in modeling risk.

17 That's simply looking at the fact

18 that we have a higher confidence range if we

19 model risk within the range of monitor values

20 that were used in the epidemiology study.

21 And so we're trying to look at

22 that lower bound of the values used as a
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1 lower bound. And that's not an hourly

2 measurement. That's actually a composite

3 monitor value that we're looking at to use

4 for that LML.

5 So it's different than the

6 background values. I think we'll probably

7 get into the clarification on this later.

8 All right, so health endpoints. 

9 We modeled quantitatively only short term

10 exposure related endpoints for this analysis.

11 I'll talk in a second about long term, and

12 just give it a couple seconds there.

13 We looked at mortality in a range

14 of respiratory morbidity endpoints. I won't

15 talk any more about that. In terms of

16 uncertainty and variability characterization,

17 we've done what we've now started to do for a

18 number of the NAAQS reviews where we've used

19 the World Health Organization's tiered

20 approach.

21 The bottom line here is we still

22 are not in a position to run a full
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1 probabilistic simulation because we don't

2 have confidence levels to place on competing

3 concentration response functions.

4 That's obviously a real limitation

5 of conducting a full probabilistic analysis.

6 So we fall back on looking at a core high

7 confidence analysis, supplemented with some

8 sensitivity analyses and a qualitative

9 treatment of uncertainty.

10 And variability, we continue to

11 sort of do this approach of looking at the

12 key sources of variability and discussing the

13 degree to which we think our model captures

14 that. I'm probably running out of time here.

15 In terms of long term exposure

16 related mortality, just in a nutshell, we're

17 planning to model, at this point, with

18 feedback from CASAC and the public, to model

19 long term related exposure mortality using a

20 respiratory related function from Jerrett,

21 most likely.

22 Our evaluation of long term
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1 respiratory endpoints had us reach the

2 conclusion that we weren't in a position to

3 model that quantitatively.

4 That's not to say that it doesn't

5 play a very critical role in evidence review. 

6 But in terms of supporting a quantitative

7 analysis for long term morbidity, we're not

8 at that point, we don't think.

9 The national scale analysis, just

10 to talk about that for a second, the national

11 scale analysis focused simply on short term

12 exposure related mortality. That's the only

13 endpoint that was modeled, current

14 conditions, as I mentioned.

15 And I think Karen had already

16 mentioned it used a fused surface. So

17 instead of just depending on monitoring, it

18 also pulled modeling into the mix.

19 And like the city specific

20 analyses, we also looked at a lowest measured

21 level in terms of modeling down to as well as

22 looking at fully modeling down to zero risk
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1 for that.

2 I'm not going to go into this. 

3 This slide just summarizes in some detail

4 some of the risk results. Is that cool? 

5 We'll move past that.

6 Possible refinements to the

7 analysis, we're definitely going to look at

8 alternative standard levels, obviously, for

9 the next version.

10 We're looking at expanding the

11 sensitivity analyses, and I think we heard,

12 obviously, some good advice that we need to

13 prioritize what we're going to be doing given

14 the timetable and resources. So I think

15 we're aware of the importance of doing that.

16 We already talked about the

17 potential different approach for simulating

18 rollback. And I mentioned that we're going

19 to look at long term exposure related

20 mortality, most likely, from a quantitative

21 standpoint. And I think that's it. So,

22 questions?
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1 CHAIR SAMET: Okay, thank you for

2 really rapidly reminding us about the content

3 of these documents. And let me ask if any

4 panel member dares to have a question.

5 No, actually, does anyone have any

6 really overarching questions because these

7 are clearly issues that we're going to be

8 touching on as discussion.

9 I was just eager to move on to the

10 public comment period because of our time

11 constraints today. So clarifications on what

12 was said. Steve?

13 DR. KLEEBERGER: I just have one

14 clarification question. On Slide number 5,

15 about the REA urban study areas, your fourth

16 bullet at the top, the inclusion of sensitive

17 populations, what is meant by that, and how

18 do you make those assessments? Is that

19 something that can be answered quickly?

20 MS. WESSON: Well, I mean, what we

21 wanted to make sure is that where we had

22 adequate studies we were making sure that we
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1 were including sensitive populations. For

2 example, in Boston --

3 DR. KLEEBERGER: Socioeconomic

4 status, kind of?

5 MS. WESSON: -- we had a specific

6 study looking at asthma in children. So we

7 wanted to make sure that we included, you

8 know, that study. So kind of along those

9 lines.

10 Equating where we had studies on

11 such sensitive populations versus where we

12 had all the other criteria met also.

13 CHAIR SAMET: I think, just to

14 point out in this copy, when I looked across

15 these documents, this would be Chapter 8, At

16 Risk Terminology, am I correct?

17 DR. HUBBELL: That is correct.

18 CHAIR SAMET: So I mean, if you

19 could just keep this in mind as you harmonize

20 the documents, try and keep this across the

21 documents here because it really glares when

22 you read through these documents, a good
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1 example of it. Yes?

2 DR. FREY: I have, I think, two

3 quick questions. So I'm assuming everything

4 that you all listed as far as proposed or

5 planned additional analyses are part of the

6 time frame that Lydia expressed.

7 And I haven't made a list of all

8 of them. But you know, Zach mentioned it and

9 others mentioned additional cities,

10 additional risk analysis, you know,

11 concentration response functions and it's a

12 pretty long list, sensitivity analysis and so

13 on.

14 So is it fair to say that that's

15 part of what you've taken into account in

16 your schedule?

17 DR. HUBBELL: The answer is yes. 

18 But the thing is those are considerations

19 we're kind of making right now.

20 DR. FREY: Are you looking for us

21 to give advice on how to prioritize?

22 DR. HUBBELL: We're looking for
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1 advice from you both about the utility of

2 different sensitivity analysis and the

3 relative importance of those compared to

4 other analyses.

5 DR. FREY: And if I could just ask

6 one quick related question?

7 CHAIR SAMET: Actually, quick,

8 follow up real quick. Go ahead and then I'll

9 --

10 DR. FREY: Yes. Another thing

11 that's not yet specified is how many

12 different levels would be considered in

13 evaluating possible alternative standards.

14 Have you given thought to are you

15 going to do two, are you going to do three,

16 are you going to do five, are you going to do

17 ten?

18 MS. WEGMAN: We're not going to do

19 ten. We'll probably try to do more than two.

20 And we seek your advice on what might be

21 appropriate.

22 DR. FREY: Okay, because I suspect
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1 that will be something we'll need to --

2 CHAIR SAMET: You know, in follow

3 up to Chris' comment, it might be useful

4 because there are so many places in the

5 documents where you see such and such will be

6 done, we are expanding from four to 12 to 16,

7 whatever.

8 Do you have a list of all these

9 sort of pending items that you could put

10 before us?

11 DR. HUBBELL: Well, they're

12 actually in the document. I don't know that

13 we've pulled them out --

14 CHAIR SAMET: Well, I know they're

15 in the document. That's the problem. Could

16 you --

17 MS. WEGMAN: Jon, you're not going

18 to consolidate --

19 CHAIR SAMET: -- a consolidated

20 list so that we could actually look at what

21 there is to be done?

22 DR. HUBBELL: I think we can pull
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1 that together for you.

2 CHAIR SAMET: Yes, I think that

3 would be helpful to you and to us. Dave?

4 DR. CHOCK: Quick question for

5 clarification.

6 MS. WEGMAN: We'll have that for

7 you tomorrow. I'm sorry, Dave.

8 DR. CHOCK: This is for Karen. I

9 wonder if in the national database, are you

10 going to use the hierarchical Bayesian

11 approach or is that being abandoned?

12 MS. WESSON: I'm sorry, can you

13 just repeat, you're talking about the fuse

14 surfaces?

15 DR. CHOCK: Yes. Are you

16 abandoning the hierarchical Bayesian

17 approach?

18 MS. WESSON: Oh, I'm sorry. No,

19 we didn't used the hierarchical Bayesian

20 approach in this analysis. I know it's been

21 used in some of the CDC analysis. But here

22 we chose to use the eVNA technique.
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1 CHAIR SAMET: Okay, any other

2 last, okay Mike?

3 DR. FOSTER: So this just, I

4 think, goes back to maybe Karen or no, no,

5 I'm sorry. It might be Jon, but so and on

6 Page 18, I have the same concerns as Dr.

7 Kleeberger in a certain sense. A new model

8 for reduced lung function predictions of

9 change in FED1.

10 Anyone in the business knows that

11 you have to consider ethnicity and all the

12 standards for ethnicity. So you're going to

13 have to put that into your nomogram.

14 CHAIR SAMET: Okay, we'll --

15 DR. FOSTER: If you're doing a

16 purely lily white comparison, most of our

17 urban centers, as we know, the diabolic

18 change in those population bases is moving

19 away from lily white.

20 CHAIR SAMET: Okay, so we'll come

21 back to that point, too probably. Daniel,

22 question? Okay, go ahead.
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1 DR. JACOB: Yes, I had two really

2 quick clarification questions. Can you go to

3 Slide 9 with those maps of baseline ozone

4 levels?

5 So I was really confused when I

6 read, you know, the chapter about Figure 4-6

7 which is the one in the top left, and which

8 says it's May-September NPA in ozone.

9 And that doesn't really make any

10 sense, and I think --

11 MS. WESSON: Right. So this was

12 the one I was pointing out that there was an

13 error.

14 DR. JACOB: Okay.

15 MS. WESSON: So in the chapter it

16 does say May through September. But the

17 ambient data is actually the entire ozone

18 season. So for California, that would mean

19 the entire year.

20 So obviously, the ozone

21 concentrations are going to be a lot lower

22 than if it was really May through September.
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1 So that's --

2 DR. JACOB: So there's a typo in

3 here. Okay, great.

4 MS. WESSON: So we'll correct it

5 in the second draft.

6 CHAIR SAMET: Okay, Helen?

7 DR. SUH: Just a quick

8 clarification question. In the exposure

9 assessment, using the APEX model, there were

10 two benchmark levels that were used, the

11 0.06, 0.07, 0.08.

12 I guess from my reading, and maybe

13 you could just comment on it is were those

14 intended as really, like, proposed possible

15 standards? Or those benchmark levels were --

16 MR. LANGSTAFF: They're health

17 benchmarks, so they're not necessarily

18 related to the standard. And those are

19 exposure levels, not you know --

20 DR. SUH: Yes, I know they're

21 exposure levels. I guess I was just trying

22 to --
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1 MR. LANGSTAFF: No, they're not

2 related to the standard.

3 DR. SUH: They're not intended to

4 be related in any way, shape or form?

5 MR. LANGSTAFF: No, no.

6 MS. WEGMAN: I don't know if I

7 would say not any way shape or form, but they

8 are not meant to be the standard levels we've

9 analyzed for the next draft.

10 DR. HUBBELL: They're based on

11 commonly used exposure levels in the clinical

12 studies.

13 MR. LANGSTAFF: There's no way

14 they would use 80 parts per billion and

15 reverse going back on a standard.

16 DR. SUH: No, no, I was just

17 confused.

18 MR. LANGSTAFF: Yes, yes, yes.

19 CHAIR SAMET: Okay, I'm going to

20 suggest that, I'm sure we'll be revisiting

21 all, you know, sort of these top line items

22 that you pointed out to us, so thank you.
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1 And what we'll do now is move on

2 to our public comment period. And as before,

3 our public commenters will have five minutes.

4 Angela will give you the one minute warning,

5 which is a tap on the microphone, apparently.

6 DR. NUGENT: Bryan, would you help

7 me out and remove those main tents, please? 

8 Thanks.

9 CHAIR SAMET: And again, we have

10 nine commenters for this afternoon. Okay,

11 then we'll go ahead and our first presenter

12 will be Sonja Sax on behalf of the American

13 Petroleum Institute.

14 DR. SAX: Hi again. This is like

15 deja vu. Thank you, again, for the

16 opportunity to speak today on behalf of the

17 American Petroleum Institute.

18 These comments will focus on the

19 general approach that's used on the first

20 draft REA for estimating health effects

21 associated with short term ozone exposures

22 based on the epidemiology evidence.
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1 So overall, it's our opinion that

2 EPA should really restrict the risk

3 assessment to respiratory morbidity outcomes

4 and to also just directly calculate the risk

5 reductions using BenMAP.

6 If it does decide to present risk

7 estimates for mortality, then EPA really must

8 fully acknowledge the uncertainty and

9 variability in these estimates, which could

10 include a risk estimate of zero based on the

11 fact that evidence is not strong enough to

12 support a causal association.

13 EPA notes that mortality is the

14 most important endpoint, even though it

15 really is only classified as likely causal. 

16 And evaluation of health endpoints with a

17 likely causal classification, if included at

18 all, should be really qualified as being much

19 more uncertain.

20 Endpoints that are only

21 suggestive, such as cardiovascular morbidity

22 and mortality, should really not be
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1 considered in the risk assessment because the

2 evidence is not supportive of these health

3 endpoints.

4 Another important issue relates to

5 the way that EPA uses BenMAP to estimate the

6 health effects. EPA generated two BenMAP

7 models to calculate total ozone related

8 risks, one down to zero and one down to the

9 lowest measured limit.

10 The lowest measured limit is more

11 appropriate because it at least considers

12 some of the uncertainty in the shape of the

13 concentration response function. But it's

14 still insufficient.

15 We suggest that EPA consider

16 instead using a background ozone level, as

17 this really reflects, as we've discussed to

18 some extent, now a more realistic scenario of

19 controllable risks.

20 Still, EPA really should consider

21 calculating directly the difference in risks

22 from current and alternative ozone standards
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1 instead of running each scenario separately

2 and calculating the difference.

3 In doing so, EPA will then be able

4 to generate the confidence bounds for these

5 risk reductions. Without the confidence

6 bounds, the risk reductions are pretty

7 misleading.

8 If EPA is considering mortality

9 endpoints, an important issue that EPA needs

10 to address is the unexplained heterogeneity

11 in the effect estimates from multi-city

12 studies.

13 Although EPA is using the city

14 specific mortality estimates, the variability

15 is minimized by the Bayesian approach that is

16 applied. Instead, EPA should, at a minimum,

17 use the regionally adjusted rather than the

18 nationally adjusted estimates.

19 In addition, EPA should use multi20 pollutant models because of the evidence of

21 confounding effects. If confounding is not

22 accounted for in the risk assessment, effect
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1 estimates will likely be overstated.

2 In conclusion, EPA should restrict

3 the risk assessment to respiratory morbidity

4 because these are really the only outcomes

5 that EPA has concluded are causal.

6 In addition, EPA should directly

7 calculate the risk reductions using BenMAP

8 and include confidence bound around these

9 estimates, which I know, EPA is planning to

10 generate these confidence bounds in the next

11 draft.

12 And lastly, if EPA presents risk

13 estimates for mortality, it must more fully

14 acknowledge the uncertainty and variability

15 in these estimates. Thank you.

16 CHAIR SAMET: Okay, thank you. 

17 Questions, comments? Okay, thank you.

18 DR. SAX: Thank you.

19 CHAIR SAMET: Next, we'll move to

20 John Heuss speaking on behalf of the Alliance

21 of Automobile Manufacturers and is on by

22 phone. Let's see, John, are you ready to go?
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1 MR. HEUSS: Yes, I am.

2 CHAIR SAMET: Okay, please go

3 ahead.

4 MR. HEUSS: Hello, how are you

5 doing there? The REA lists a number of

6 goals. We have comments on eight. The first

7 listed goal are an estimate for people with

8 ozone, with moderate or greater exercise for

9 global.

10 This calculation, however, is not

11 directly a measurement of these effects or

12 risk to public health. In addition, there

13 are three ways of -

14 CHAIR SAMET: John, hang on one

15 second. We're not hearing you too well. Are

16 you on a speaker phone?

17 MR. HEUSS: Okay. Let me try to

18 do it this way, is that better?

19 CHAIR SAMET: Yes, that's much

20 better. We were losing a lot of words.

21 MR. HEUSS: Okay. So I made the

22 point that the APEX model predict more 
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1 ventilation that's been observed in the real

2 world, and EPA has acknowledged this.

3 The second way relates to how EPA

4 defines moderate or greater exercise over

5 eight hours. The REA follows the approach

6 you got in 1996 of defining EVRs between 13

7 and 27 as moderate.

8 Risks are calculated for

9 individuals with daily eight hour average EVR

10 greater than 13 using response functions

11 developed from chamber study data conducted

12 at EVRs of 20. Significantly higher.

13 The Johnson showed that the EPA

14 algorithm predicts the 95th percentile eight

15 hour EVR is between 14 and 15, while the EVR

16 used in clinical studies of 20 is about the

17 99th percentile. Thus, the resulting

18 headcounts and risks are unreasonably high.

19 The third way is that ozone at

20 breathing height is lower than ozone at

21 measurement height. This was acknowledged in

22 the last review, but not evaluated in the
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1 risk assessment even though the analogous

2 difference in the welfare situation was

3 considered.

4 The sensitivity to these three

5 factors should be evaluated in the next

6 draft. The second listed goal is to provide

7 estimates of the number of people with

8 various FEV1 decrements.

9 This calculation is necessary but

10 not sufficient to estimate risk of adverse

11 effects since it does not include estimates

12 of lung function decrements accompanied by

13 respiratory symptoms, as the ETS guidelines

14 recommend.

15 It is noted in the draft, the

16 risks are similar to those estimated in the

17 last review. We urge EPA to include the new

18 McDonnell et al 2012 concentration response

19 function in the next draft and discuss how

20 the results relate to adversity.

21 The third goal is to provide

22 estimates of the potential magnitude of
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1 premature mortality and morbidity health

2 effects. Rather than using EPA's preferred

3 positive associations, we urge the agency to

4 explore the full range of associations in the

5 literature.

6 This has not become apparent as

7 Koop and Tole pointed out in 2004 when model

8 uncertainty is accounted for in the analysis,

9 measures of uncertainty associated with these

10 point estimates become very large.

11 Indeed, they become so large that

12 hypothesis that air pollution has no effect

13 on mortality is not implausible.

14 The fourth and fifth goals are to

15 understand the influence of various inputs

16 and assumptions on the risk estimates and the

17 uncertainties of those estimates. This is

18 laudable and important.

19 In addition to the issues for the

20 clinical studies, the REA should evaluate the

21 wide range of positive and negative

22 associations in the individuals to these, and
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1 the temporal and spatial variations in

2 combined associations in multi-city studies.

3 For example, in the regional

4 analysis by Bell and Dominici, 2008, only two

5 of seven regions had positive and

6 statistically significant ozone mortality

7 associations, while two had small negative

8 associations.

9 Another example, the Medina-Ramon

10 study of 36 U.S. cities' hospital emissions,

11 the combined associations for two categories

12 were positive in the one piece, but they were

13 negative in the cold season and not

14 significant over all year.

15 By switching the baseline analysis

16 for the Medina-Ramon study to the all year

17 result, and exploring the spatial and

18 temporal differences, the limitations of the

19 epi risk will become apparent.

20 The sixth goal is to understand

21 the national mortality burden associated with

22 ozone. Rather than using the Bayesian
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1 combined estimates from Bell et al 2004, the

2 variety of other possible approaches with

3 baseline should be considered.

4 If the individual city results

5 from Bell et al are considered, the pattern

6 becomes a patchwork of positive and negative

7 cities, which is not biologically plausible.

8 If the regional combined results

9 from Bell and Dominici or Smith et al 2009

10 are considered, the ozone mortality impact

11 varies dramatically across the country. If

12 the combined results from the study for all

13 cause mortality would be on controlled are

14 considered --

15 DR. NUGENT: Excuse me, one

16 minute.

17 MR. HEUSS: -- in that case, none

18 of the 16 wild combinations that are positive

19 in significant association in the U.S. where

20 these other possible traces of the baseline,

21 the futility of estimating a national

22 mortality burden becomes apparent.
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1 DR. NUGENT: Excuse me, Mr. Heuss,

2 you have one minute left.

3 MR. HEUSS: Thank you. In

4 addition, the existence of a substantial

5 threshold for the first physiological effects

6 in control studies is not consistent with

7 EPA's assumption that the dramatically more

8 severe effects suggested by some epi studies

9 have no threshold.

10 Such an assumption is not

11 consistent with either the general principles

12 of toxicology or the specific findings of

13 ozone tox studies. Thank you.

14 CHAIR SAMET: Okay, thank you. 

15 Questions or comments? Okay, thank you. 

16 Next, we'll move on to Richard Smith from the

17 University of North Carolina. Richard?

18 DR. SMITH: Point of order, Mr.

19 Chairman, before I begin my discussion. I

20 submitted a written comment, but I now

21 realize that this would be aptly more

22 appropriate for this morning's discussion.
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1 I would like to leave my written

2 comment on the table, but to speak

3 extemporary for five minutes specifically

4 about the risk assessment, is that in order?

5 CHAIR SAMET: Certainly.

6 DR. SMITH: Thank you very much. 

7 I would like to speak mostly about the

8 epidemiological aspect of the risk assessment

9 that we've just heard.

10 I was extremely surprised to hear

11 the statement that confidence intervals on

12 the dose response, on the concentration

13 response curves are not available.

14 That statement's not correct. 

15 Bayesian posterior estimates have been

16 published. There's some very detailed

17 results in my 2009 paper, Inhalation

18 Toxicology.

19 But, I mean, for the purpose of

20 the present discussion, the results that were

21 published by Dr. Bell several years earlier

22 are also extremely relevant.
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1 And you can take a Bayesian

2 posterior interval and interpret the 95

3 percent coverage interval as a confidence

4 interval.

5 So, you know, it was stated that

6 hierarchical Bayesian models were not being

7 used. I would like to say why not? These

8 analyses were published many years ago, and

9 the methodology is fairly standard by now.

10 I would like to point out the part

11 of the risk assessment that we're talking

12 about here doesn't actually cite my 2009

13 paper. Though, as far as I can tell, the

14 paper meets all the criteria that were listed

15 there.

16 There is a point about the

17 availability of the coefficients for

18 concentration response curves. Well, Table 1

19 of my paper includes very detailed lists of

20 coefficients under many different models

21 including non-linear models and models for

22 the joint effective of ozone and PM10.
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1 And, I mean, the published results

2 in the paper are the nationally averaged

3 results. But of course, I would be very

4 happy to make the individual city results

5 available to anybody who wants them.

6 There is a point that I would like

7 to make about the use of Bayesian posterior

8 distributions, however, which is to emphasize

9 this is something that was in my 2009 paper

10 that I don't think Dr. Bell emphasized in her

11 papers which is that different estimates, you

12 know, the effect of the prior distribution on

13 those estimates is not trivial.

14 In my 2009 paper, I referred to a

15 national prior and regional prior and also

16 priors based on spatial distributions. And

17 posterior distributions for the first two

18 models were published there.

19 So I feel that the risk assessment

20 should take count of all those results. 

21 There are some other aspects of uncertainty

22 assessment that didn't seem to me to be
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1 addressed.

2 The discussion about rollbacks and

3 whether you're going to use quality models in

4 place of rollbacks. Are you taking account

5 of uncertainties there because I didn't hear

6 that mentioned.

7 You know, it seems to me there has

8 to be some posterior distribution for the

9 ozone level as well, if you're talking about

10 implementing a new standard.

11 The other comment I would like to

12 make is about there's questions about the

13 period of study and the availability of data

14 for all this.

15 At least, in my opinion, the risk

16 assessment ought to be based on the same

17 period as the data that the epidemiological

18 assessments are based on.

19 Otherwise, you can't control, for

20 example, for possible drifts in the air

21 pollution, health effects coefficients over

22 time that might be due to changes in the air
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1 pollution mix or something like that.

2 The analyses that I've done and

3 have published were based on the NMMAPS data

4 set that ended in 2000, which is now a 12

5 years out of date data set.

6 I am aware that more up to date

7 data sets have been derived but have not been

8 published. In my opinion, this should

9 ultimately be an agency decision on what

10 period of time you want to make these risk

11 assessments based on and how up to date data

12 are you basically willing to release.

13 But I feel the appropriate way to

14 do it is first publish the data, including

15 the individual mortality data, or sorry, the

16 city level mortality or morbidity data that

17 you're using --

18 DR. NUGENT: Excuse me.

19 DR. SMITH: -- and then run the

20 risk assessments on those data. And you

21 know, the calculations themselves are not

22 difficult. I mean, I have, myself, done
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1 everything that you guys are describing based

2 on the NMMAPS data and quadratic rollback

3 functions.

4 These are not very complicated

5 computations and I feel these sorts of

6 considerations should be taken account of in

7 the risk assessment. Thank you very much.

8 CHAIR SAMET: Okay, thank you. 

9 Any questions, comments? Okay, thank you. 

10 Next, we'll move to Samuel Oltmans.

11 MR. OLTMANS: Thank you for this

12 opportunity to expand some on the role of

13 background in characterizing the diurnal

14 variations that are used in the risk

15 assessment.

16 Sort of a prefatory remark here, I

17 think there's a strong heritage and well

18 vetted information on attributing various

19 sources to background, both in the modeling

20 and observational realm.

21 So I think we can say something

22 about sources in terms of their contribution
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1 to the background. And I think this is in

2 keeping with the ISA, and maybe somewhat in

3 disagreement with Daniel's remarks on our

4 ability to say something about the

5 contribution from the stratosphere.

6 Again, I'm going to use Trinidad

7 Head as a basis for trying to describe what

8 might be an observational view of the

9 background diurnal variation.

10 And as I mentioned before, this is

11 a very well situated site for looking at flow

12 that comes from the Pacific Ocean.

13 And the thing I want to expand on

14 here is that we not only have the opportunity

15 to look at what we usually think of as the

16 background during the daytime measurements,

17 but at night, a strong portion of the data is

18 also representative of flow from the Pacific

19 Ocean and I think gives a very good idea of

20 the diurnal variation in the background ozone

21 concentration entering the west coast of the

22 United States.
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1 These figures show the background

2 from both the day and night data at Trinidad

3 Head for two seasons, March, April and May,

4 July, August and September show that during

5 the daytime in the spring, values are in the

6 low to mid 40s, where at night, they never

7 really go lower than the upper 30 parts per

8 billion.

9 During the summer, they go

10 somewhat lower during the nighttime into the

11 20 part per billion. But these numbers are

12 fairly large. And the range of values during

13 the daytime in the spring is 25 to 55 ppb.

14 And in the summer, during the

15 daytime range from 15 to 30 parts per

16 billion. As I mentioned before, Trinidad Head

17 is probably representative of air flowing in

18 along the whole western coast of the United

19 States.

20 And we see this in looking at

21 trajectories, for instance, at a site like

22 Channel Island, whereas in a matter similar
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1 to Trinidad Head, most of the air flow is off

2 the Pacific Ocean, primarily from the

3 northwest.

4 This is a comparison of those

5 figures I showed earlier of the spring

6 observed diurnal variation in the spring and

7 summer. This is compared to a modeled result

8 from Sacramento, a northern California

9 location that's used in the risk assessment.

10 And you can see that the values in

11 the spring from the observed values are quite

12 a bit higher than you see in the model for

13 the spring and summer values at Sacramento.

14 DR. NUGENT: Excuse me, one

15 minute.

16 MR. OLTMANS: So in conclusion, I

17 would like to say that at Trinidad Head, this

18 well located site gives a good idea of what

19 might be representative background diurnal

20 variation that the values are rather large,

21 ranging from 25 to 55 for the diurnal

22 variation in the spring, and 15 to 30 in the
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1 summer.

2 And these values are significantly

3 higher than what's shown in the modeled

4 values for places like Sacramento and Los

5 Angeles that might be represented by Trinidad

6 Head.

7 And I think by using these

8 observational values, you get a better

9 picture of what the background value diurnal

10 variation might be. Thank you.

11 CHAIR SAMET: Okay, thank you. 

12 Questions? Okay, thank you. Next, Allen

13 LeFohn?

14 DR. LEFOHN: Thank you, Mr.

15 Chairman and CASAC for allowing me the

16 opportunity to address you again. My name is

17 Allen LeFohn.

18 I would like to address a couple

19 of things before I get going. The oil and

20 gas fields in Wyoming had nothing to do with

21 the Ellis International Park's exposures of

22 the elevations.
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1 Why? Because the oil and gas

2 peaks occur at higher concentrations in

3 February. In January, February and March is

4 when the enhanced concentrations occur from

5 those fields.

6 The winds blow from the west to

7 the east, and they do not blow to the north

8 to affect Yellowstone. The peaks that I

9 showed earlier today, with the number of

10 concentrations greater than equal to 50

11 occurred in March, April, May and in June,

12 it's out of phase.

13 Schnell et al wrote a paper about

14 that. It's probably the only thing in the

15 peer review literature that deals with the

16 oil and gas fields. Nature Geoscience 2009,

17 Samuel Altman's the second author, and

18 concurs with what I just said.

19 Second, in terms of the importance

20 of the stratosphere, there was a meeting in

21 Austin in March, the end of March into early

22 April last year.
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1 McDonnall Buhler was a result of

2 that workshop. There were ten experts that

3 were brought together, Daniel Jacob was one

4 of them, Samuel Altmans was number two, I was

5 number three and there were seven others.

6 Needless to say, Daniel believes

7 very strongly the stratosphere is not very

8 important. I, on the other end of the

9 spectrum believe it is very important.

10 And I would encourage all members

11 of CASAC to please read that paper that

12 resulted from our two and a half day

13 workshop. It's cited in the ISA, and I think

14 it's very important.

15 Dealing now with background ozone,

16 the diurnal patterns of background levels are

17 too low based on the rollback methodology. 

18 In the criteria document in 1996, Page 4-46,

19 there's reference to diurnal patterns should

20 not be used for assessing exposure.

21 These average concentrations in

22 the patterns smooths over the variation. 
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1 I.e., you're essentially averaging out the

2 actual variation you're looking for in terms

3 of the important components.

4 I wrote that. I was the lead

5 author of the air quality chapter. Also

6 participated in the vegetation chapter as the

7 lead author for exposure response for

8 vegetation.

9 The CMAQ HDDM model employed in

10 the second version may also underestimate the

11 contribution of background. If there's not a

12 stratospheric, tropospheric exchange module

13 that adequately captures that, then the

14 estimates of background will essentially be

15 low.

16 Using the heat map table of the 12

17 cities, approximately 50 percent or more of

18 the ozone related all cause mortality based

19 on epidemiological results levels are between

20 25 and 50.

21 Measured background concentrations

22 are in the range of 25 to 50. The REA
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1 illustrates the probabilistic exposure

2 response relationship for FEV1 decrement

3 greater than ten percent, as it notes.

4 Although the probability of

5 response below 50 ppb is low, a large

6 fraction of population is estimated to be

7 exposed to these low levels, which represent

8 background.

9 DR. NUGENT: Excuse me, Mr.

10 LeFohn, one minute left.

11 DR. LEFOHN: Thank you. Lowest

12 measurement level, LML values appear to be

13 well below background levels. The deltas

14 also appear to be related to the absolute

15 values, even though in the REA, it says that

16 it seems to not be related, it is.

17 Background ozone is an important

18 underpinning by removing the focus of

19 uncertainty associated with background. The

20 current version gives too much credence to

21 the predicted clinical and epidemiological

22 risk estimates.
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1 You can't see this, but you've

2 already discussed the MLL levels are below

3 background. If you look at the colors, you

4 will see that essentially, nine of the 12

5 cities were predicted to experience

6 approximately 50 percent or more ozone

7 related all cause mortality for daily maximum

8 levels between 25 and 50.

9 This is the table and this is the

10 statement that concerns with even though the

11 response is low at 40, the large number of

12 population will essentially drive the risk

13 very high at the very low levels. That's it.

14 Thank you.

15 CHAIR SAMET: Okay, thank you. 

16 Questions or comments?

17 DR. LEFOHN: Thank you very much.

18 CHAIR SAMET: Okay, thank you. 

19 We'll move on now to Christopher Emery on

20 behalf of ENVIRON International Corporation.

21 MR. EMERY: My comments today will

22 focus basically on the approach to project
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1 urban air quality data for the purposes of

2 calculating risk at various levels of the

3 ozone standard.

4 First, on the issue of air quality

5 data, so if the analysis using BenMAP, as I

6 understand it, missing data for one or two

7 hours are filled in by interpolation, but

8 longer periods of missing data are not

9 replaced.

10 For analyses using APEX, much more

11 complex filling procedure was employed,

12 although it's not clear if all the steps were

13 actually in the document.

14 Section 4 references Appendix 4B

15 for additional information. The Wells

16 references Section 5 of the REA. But I

17 believe that both of those references should

18 be 5B, so there's some apparent mixup in

19 citing the Appendix.

20 A clarifying discussion should be

21 included on why there are such major

22 differences in data preparation between the
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1 two analyses.

2 The 2007 REA included 75 percent

3 data completeness criteria and to accept a

4 site for exposure calculations. As I

5 understand it, the current REA requires only

6 that monitors must have sufficient data to

7 calculate a valid three year design value.

8 This criterion is much more lax

9 because it allows for a significantly less

10 data than 75 percent. Furthermore, the

11 approach in Appendix 5B does not consider

12 cases when all the monitors are missing data

13 for more than six hours, consecutive hours I

14 should say.

15 The problem is extensive data gap

16 filling can result in skewing of the hourly

17 frequency distribution, thereby

18 misrepresenting conditions of the monitored

19 area.

20 And then I think the rollback will

21 probably exacerbate that problem. A more

22 complete description of the criteria and data
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1 filling methods needs to be described in the

2 REA.

3 Second, on the issue of quadratic

4 rollback, high resolution geoscan simulations

5 were used instead of background floor. EPA

6 has compared higher resolution CAMx and GEOS7 Chem simulations, as we talked about earlier.

8 And CAMx estimated background

9 ozone were consistently higher in most areas

10 of the U.S. We also have CMAQ simulations

11 that show the same thing, they're even higher

12 than the CAMx.

13 So background estimates from all

14 three models should be used in the risk

15 calculations to characterize and document

16 sensitivity to the background estimates.

17 The quadratic rollback technique

18 is too simplistic. Specifically, the use of

19 one set of rollback coefficients for all

20 sites and cities doesn't account for

21 variability and chemical conditions, factors

22 used to set a background floor are not
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1 allowed to be greater than one.

2 So there's no backing off on the

3 NOx dis-benefit. The REA shows that

4 background scaling leads to adjustments that

5 are frequent and small.

6 So it means that it doesn't

7 reflect concentrations resembling a

8 background floor. The entire approach

9 actually biases the outcome to minimize ozone

10 across the entire frequency distribution.

11 The REA mentions these

12 limitations, but they need to be emphasized

13 when introducing the quadratic rollback

14 approach, so the reader knows what's coming.

15 Finally, on the issue of model

16 based rollback using HDDM, the improvements

17 offered include site specific rollback,

18 that's a good thing, non-linear responses to

19 precursor reductions.

20 And we're encouraged that the EPA

21 is developing a viable technique similar to

22 the approach we've discussed with EPA earlier
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1 this year. We're actually conducting our own

2 HDM modeling using 2006 CAMx data sets that

3 are described in the ISA.

4 The figures that I'm showing up

5 here are examples of our CAMx HDDM results

6 for a site in Atlanta. The measurements are

7 in blue. The 50 percent emissions case

8 that's both NOx and VOC are shown in red.

9 And the important thing to take

10 home from this is that the controls reduced

11 the ozone frequency distribution at both

12 ends, not just the high, while increasing the

13 mid-range toward the simulated background

14 level.

15 I quickly note several remaining

16 issues that need to be thought about in the

17 model based rollback. One, the approach to

18 project sensitivity to many years needs to be

19 further developed.

20 Multiple HDVM runs at various NOx

21 levels will be necessary to properly address

22 the full range of NOx. And the EPA's
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1 mentioned that.

2 DR. NUGENT: Excuse me, Mr. Emery,

3 one minute left.

4 MR. EMERY: An entire ozone season

5 or year should be simulated during the 2006

6 to 2010 analysis period. But it might be

7 necessary to simulate more than one year.

8 While HDDM alleviates the need to

9 separately apply a background floor like

10 what's done in the quadratic rollback, it is

11 subject to the usual sources of model

12 uncertainty.

13 This is important. It's

14 imperative the EPA rigorously evaluate and

15 document CMAx replication of the observed

16 ozone for the year they actually ran, and

17 also to evaluate its background ozone

18 estimate with respect to the modeling results

19 that have already been published and

20 documented in the ISA.

21 So ENVIRON looks forward to

22 sharing our HDDM model results and
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1 experiences with EPA to further develop this

2 model based rollback approach.

3 CHAIR SAMET: Okay, thank you. 

4 Questions, comments? Yes, Fred?

5 DR. MILLER: Based on your

6 comments, would you say that the quadratic

7 rollback should be continued to go forward,

8 or to switch to the HD as far as helping the

9 agency to prioritize their time and

10 resources?

11 It's not clear to me, I personally

12 don't see the value of the quadratic at this

13 point given the other, but I would like a

14 comment on that.

15 MR. EMERY: Thanks for the

16 opportunity to comment. I would say, in

17 terms of prioritizing, I would go with HDDM

18 or a model based rollback and leave quadratic

19 behind.

20 DR. NUGENT: Excuse me, Mr. Emery,

21 I don't believe I've received directly that

22 copy of that slide. I wonder if you could
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1 provide it to me?

2 MR. EMERY: I will provide it. 

3 Those same pictures are in my written

4 submission. But I do know it has to be

5 separate, so I will provide it.

6 CHAIR SAMET: Okay, anything else?

7 Okay, thank you. Next, Julie Goodman on

8 behalf of the American Forest and Paper

9 Association.

10 DR. GOODMAN: Thank you for the

11 opportunity to speak on behalf of the

12 American Forest and Paper Association.

13 My comments this afternoon are

14 focused on the characterization of health

15 risks based on controlled human exposure

16 studies in the first draft REA.

17 EPA developed exposure response

18 functions, or ERFs, for lung function

19 decrements from several controlled human

20 exposure studies.

21 They did this based on two models,

22 one that was used in the 2007 Ozone NAAQS
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1 Review, and an alternative model by McDonnell

2 et al 2010.

3 The quantitative results of these

4 risk assessments were recently released in an

5 update to the first draft REA. EPA said it's

6 planning to update the ERF using new data

7 presented in the third draft ISA, including

8 those from the Hazucha et al 1992, Kim et al

9 2011 and Schelegle et al 2009 studies.

10 EPA should consider more recent

11 models by Schelegle at al 2012 and McDonnell

12 et al 2012 that supercede the models used in

13 the REA.

14 McDonnell et al 2012 updated their

15 original exposure response model from 2007

16 and 2010 with additional data and the

17 inclusion of a threshold.

18 The authors considered data from

19 23 human controlled exposure studies and, in

20 some models, used a threshold defined as 59

21 parts per million liters of inhaled air, thus

22 accounting for both the level of exercise and
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1 the ozone concentration.

2 McDonnell et al 2012 reported a

3 better fit with the threshold model compared

4 to previous models, particularly for the

5 early time points and at the lowest exposure

6 levels.

7 Because these exposures are more

8 relevant to the NAAQS, the threshold model

9 presented by McDonnell et al 2012 provides a

10 more accurate estimate of risk for the

11 general population.

12 Rather than using a model based on

13 group mean FEV1 decrements, EPA used a model

14 based on the percentage of people with lung

15 function decrements over a certain value,

16 ten, 15 or 20 percent.

17 This is inappropriate. It

18 overestimates the significance of individual

19 responses, particularly at lower ozone

20 exposure levels due to the individual

21 variability of FEV1 when repeatedly measured

22 by diagnostic spirometry.
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1 Because there's only one

2 measurement per person at a given exposure

3 time, the studies included in these models

4 are designed to characterize a group mean

5 response rather than individual responses.

6 For example, in a study where

7 repeated FEV1 measurements were made on

8 single healthy individuals exposed to clean

9 air, the observed variation in FEV1 was up to

10 plus or minus five percent in some subjects.

11 Based on this range, a substantial

12 segment of the low exposure individuals

13 included as responders in the EPA assessment

14 may simply fall within the experimental

15 variability.

16 Also, FEV1 is only one measure of

17 respiratory impacts. And other endpoints,

18 particularly symptoms, are generally required

19 to determine if someone is experiencing an

20 adverse effect.

21 For example, the American Thoracic

22 Society 2000 guidelines for identifying
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1 adverse effects includes both pulmonary

2 changes and respiratory symptoms.

3 In a key clinical study, Schelegle

4 et al 2009 reported significant changes in

5 both FEV1 and symptom scores only after over

6 six hours of exposure to an ozone level of 80

7 parts per billion and following rigorous

8 exercise.

9 Thus, while FEV1 may be used as a

10 biomarker by itself, it likely overestimates

11 the number of individuals experiencing

12 adverse effects.

13 Finally, EPA stated that it

14 assumed that asthmatic school age children

15 are more susceptible to ozone exposures than

16 non-asthmatic children.

17 CASAC recently indicated that

18 overall, the evidence that asthmatics are

19 more sensitive to the respiratory effects of

20 ozone is weak, and we came to the same

21 conclusion based on a review of epidemiology,

22 controlled human exposure and toxicity
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1 studies.

2 It is noteworthy that in Figures

3 6-8 to 6-15 of the REA, the risks in

4 asthmatic school age children differ little,

5 if at all from risks in all school age

6 children in four urban areas.

7 In conclusion, EPA should rely on

8 a model that incorporates a threshold for

9 calculating risk such as the one by McDonnell

10 et al 2012, and should use the absolute level

11 of FEV1 rather than a level above or below a

12 cutoff.

13 EPA should also reconsider the

14 evidence that indicates that asthmatics are

15 not more sensitive to ozone. On behalf of

16 the American Forest and Paper Association,

17 thanks for your consideration.

18 CHAIR SAMET: Okay, thank you. 

19 Questions? Okay, thank you.

20 DR. GOODMAN: Thank you.

21 CHAIR SAMET: Okay, next, Anne

22 Smith from the Utility Air Regulatory Group.
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1 DR. SMITH: Thank you. I'm Anne

2 Smith of NERA Economic Consulting speaking on

3 behalf of UARG. I want to focus my comments

4 on the HDDM rollback method that's being

5 proposed.

6 It has potential benefits. Most

7 importantly, it replaces the generic and

8 hypothetical assumptions that need to go into

9 a quadratic rollback towards use of more

10 location specific fundamentals of atmospheric

11 chemistry.

12 In doing so, the background ozone

13 estimates become endogenous to the rollback.

14 There are a few limitations worth

15 considering. It produces a lot more

16 complexity in the development of the inputs

17 to the risk analysis.

18 And it causes a loss of ability to

19 test for uncertainty in what the background

20 level is, model uncertainty. It creates,

21 also, a loss of the ability to assess health

22 risks above background levels.
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1 And a lost ability, if the

2 quadratic rollback is thrown out at this

3 time, to compare it to prior risk assessment

4 results. I just have a few thoughts and

5 questions on the method.

6 First, HDDM requires an explicit

7 assumption about what specific emission

8 reductions will be performed in order to

9 achieve attainment with an alternative

10 standard.

11 This is different from the

12 quadratic rollback where emissions are never

13 even mentioned.

14 And given the newness of the

15 approach of HDDM for the REA, it suggests the

16 need for some thoughtful exploration of what

17 those emissions reductions assumptions ought

18 to be.

19 Have a look at what EPA has

20 assumed so far in its two case studies. The

21 Simon memo that speaks to the case study says

22 that emissions are being reduced domain wide.
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1 That's what the assumption is in

2 order to achieve attainment in those two case

3 study cities of Detroit and Atlanta. And the

4 domain is the area in that blue square on the

5 graph on the map.

6 It's a huge area, and presumably

7 emissions are being reduced by the same

8 proportion over all those states in order to

9 simulate attainment for Detroit or Atlanta.

10 I think it's a question we need to

11 ask is are these realistic assumptions? It's

12 just a debate that needs to be had before we

13 just move forward into using that particular

14 assumption on the HDDM.

15 And also, no matter what

16 assumption you use, what are the

17 sensitivities of the risk estimates to

18 different ways of simulating attainment by

19 emissions reductions? Similarly, the

20 emissions are reduced by specific sectors.

21 And presumably, based on Simon,

22 there's an equal percentage reduction going
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1 on and sources as diverse as area sources or

2 point sources throughout that domain. That,

3 also, is a question of realism.

4 But if this method is used,

5 critical new assumptions that are inputs to

6 the REA will be what those reductions are, by

7 species, by source category in each city and

8 for each of the alternative NAAQS, and in

9 what locations?

10 And those really should be

11 reported if we move into this. It's just an

12 observation that that's important new

13 information that will be necessary if the

14 HDDM method is used.

15 Now, the HDDM approach will

16 conceal the implicit levels of background

17 ozone by making them endogenous. And that

18 has some consequences that we need to be

19 aware of.

20 It'll be impossible to estimate

21 health risks for exposures above background

22 when you don't know what the background is
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1 inside the HDDM simulation.

2 It'll also be impossible to do

3 sensitivity analysis to model uncertainty

4 about the parameters that determine that

5 background.

6 Additionally, the HDDM based

7 approach planned for the REA will understate

8 the true range of temporal variability in

9 those background levels.

10 They'll be endogenous, but they'll

11 still be some reduction of the variability,

12 and that comes from this averaging by bit day

13 types.

14 DR. NUGENT: One minute.

15 DR. SMITH: But the important

16 point of it is that it can create an

17 overstatement of the feasability of achieving

18 different alternative NAAQS. It may make

19 certain rollbacks appear feasible that are

20 not physically feasible.

21 And that will result, when that

22 happens and if it happens, in the REA
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1 overstating what the benefits are for the

2 alternative NAAQS rules.

3 So my final point is this

4 quadratic rollback is a new method. And it

5 merits some performance evaluation rather

6 than simply throwing out the quadratic

7 rollback at this time, in which case you

8 loose the ability to do the performance

9 evaluation.

10 So in order to provide for that,

11 if we're going to move to using the HDDM, the

12 REA should still contain the quadratic

13 rollback results as well as, not just one

14 HDDM approach but several based on the

15 different assumptions about how emissions

16 would be reduced.

17 That is more work, but if you

18 don't do this, well if you do this it does

19 allow you still to retain insights about how

20 differences in this risk assessment and the

21 prior one may be tied to the assumptions in

22 the rollback method or to other aspects that
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1 are changing in the REA. And one minute?

2 DR. NUGENT: I think your time is

3 up now.

4 DR. SMITH: Okay. I gave my

5 copies of my slides to Dr. Nugent. And my

6 last two slides just contain some examples of

7 what I mean, specific examples of what I mean

8 by evaluative approaches.

9 CHAIR SAMET: Okay, thank you. 

10 Questions, comments? Okay, thank you. Next

11 and last, Deborah Shprentz on behalf of the

12 American Lung Association.

13 MS. SHPRENTZ: Thank you. I have

14 just a few comments to build on some of the

15 points that I made this morning. First of

16 all, with respect to the risk assessment, you

17 know, what are the populations that are

18 included and who's excluded.

19 It seems that right now, EPA is

20 systematically excluding children aged zero

21 to five from the quantitative assessment of

22 risk, even though these children are
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1 identified as an especially susceptible

2 population in the ISA.

3 And I think it's fair to say that

4 young children of preschool age represent a

5 significant proportion of the population of

6 total children. And by excluding them, any

7 estimates derived from the risk assessment

8 are going to be gross underestimates.

9 So what's the rationale for

10 leaving them out? EPA says, well they're not

11 in CHAD, they don't have the activity data in

12 the model.

13 But just to leave them out

14 entirely, that doesn't seem to make sense. 

15 Obviously, babies, small children, they're

16 spending time outside. Some of them are very

17 active, they like to play outdoors.

18 There must be some surrogate

19 measure that could be used to provide a

20 reasonable approximation of their exposure

21 that would allow EPA to include them in the

22 risk assessment.
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1 Secondly is the question of

2 outdoor workers. And I now understand from

3 EPA's presentation that this important

4 segment of the population will be included in

5 the next draft of the risk assessment.

6 And we're very pleased to see

7 that. They're an important group. They

8 haven't been evaluated, they weren't

9 evaluated in the last ozone review.

10 And obviously, there are many

11 outdoor occupations where people are, you

12 know, not just outside all day breathing the

13 air, but also exercising heavily which serves

14 to increase their dose of ozone air

15 pollution. So we're glad to see that they'll

16 be included in the next draft.

17 Thirdly, we're pleased to see that

18 EPA will be including the elderly in the

19 subsequent draft, and that they're moving to

20 include people age 65 or older, not just

21 those that are 70 or older.

22 We find that this is consistent
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1 with the epidemiological studies which often

2 rely on medicare data to explore the health

3 impacts on senior populations.

4 And finally, we would like to see

5 an illustration that shows, you know, what

6 populations are included and what are

7 excluded to put the overall results of the

8 risk assessment into perspective.

9 As I mentioned this morning, 2012

10 was a bad year in terms of air quality as was

11 2011. And it's hot, it's getting hotter. To

12 the extent that the risk assessment is

13 looking at years with cleaner air quality,

14 it's going to greatly underestimate the

15 benefits of alternative air quality standards

16 for ozone. And we would like to see EPA

17 explore ways to characterize this important

18 source of underestimation.

19 We agree that the risks of total

20 exposure should be modeled because, as I

21 mentioned this morning, the lungs don't

22 differentiate based on distorts of the ozone.
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1 Also, we would like to see the

2 lung function decrement --

3 DR. NUGENT: Excuse me, Ms.

4 Shprentz, one minute left.

5 MS. SHPRENTZ: Okay. We would

6 like to see the lung function decrement

7 somehow put into context with a chain of

8 other adverse respiratory effects that are

9 caused by ozone such as inflammation, the

10 other effects elaborated on in the ISA

11 because what happens is the policy makers,

12 you know, it's just easy to look at the

13 results.

14 You sort of glom onto the

15 quantitative numbers. But obviously, they're

16 not telling the whole story.

17 And finally, we have a comment on

18 how these results are communicated. You

19 know, the most important driver in the

20 results is really what is the baseline air

21 quality that's assumed?

22 So if you're looking at the city
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1 specific risk results, sometimes there will

2 be a number, you know, that risks in New York

3 City are X, Y, Z, but there's no explanation

4 to account --

5 DR. NUGENT: Time's up.

6 MS. SHPRENTZ: -- for the fact

7 that if the air quality in that particular

8 city is cleaner, then whatever the scenario

9 is that's being modeled, well you're not

10 going to have substantial benefits.

11 And so we would like to see that

12 notion better conveyed in the risk assessment

13 and then carried forward into the policy

14 assessment.

15 CHAIR SAMET: Okay, thank you. 

16 Are there questions or comments? Okay, thank

17 you. This ends the public comment period. 

18 And thanks to our commenters.

19 We have a lot of work to do and

20 little time to do it. But let's take a ten

21 minute break anyway. And so let's get back

22 together about five of four.
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1 (Whereupon, the above-entitled

2 matter went off the record at 3:44 p.m. and

3 resumed at 3:57 p.m.)

4 CHAIR SAMET: Okay, we are back

5 and launched and reviewing the Health Risk

6 and Exposure Assessment, Chapters 1 to 3. 

7 Fred?

8 DR. MILLER: Okay, I have some

9 comments in terms of Chapter 1. The main

10 thing being that in Chapter 1 there's no

11 consideration of the secondary standard,

12 other than to say that it's the same as the

13 primary.

14 And to really, appropriately,

15 characterize the previous discussions, it

16 should be added that what was proposed is

17 arranged by CASAC. And that the fact that

18 the Administrator chose to ignore it last

19 time around. There's nothing like that in

20 here. And I think, to tell the full story,

21 you need to have that.

22 The introductory chapter, to me,
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1 clearly communicates a lot of the information

2 that there's some misleading statements. For

3 example, on Page 1-5, Line 17, it states that

4 the range evaluated was 0.07 to 0.075 and

5 it's not until the subsequent page that it's

6 corrected. So I don't know if that's a typo

7 or what, but the range that CASAC recommended

8 last time was 60 - 70 PPB and that's

9 clarified later in the chapter, but it's

10 misstated up early.

11 Another thing that the chapter, I

12 think, places a different perspective on, has

13 to do with quoting the Administrator as

14 saying that, the CASAC made in their

15 recommendations on the previous time, that

16 they put more weight on the exposure and risk

17 assessments. I was there, and we did not.

18 The science supporting health

19 effects below 0.08 was what was the driver on

20 the different studies -- epidemiology field

21 studies and the berry pickers, even down to

22 00.04 parts of the Adams study and so on. 
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1 And so the analysis, the risk analysis, did

2 not come into play as far as saying what are

3 the ranges scanned.

4 So that, to me, is an

5 overstatement of our deliberations. And I

6 can go back and get the records and I quote

7 the full paragraph, I'll bring up later,

8 where I -- it has to do with policy relevant

9 background and aspects that, to me, the

10 agency misinterpreted what CASAC was saying

11 at the time when we made this statement

12 there, and I'll save that for later.

13 So, I don't know if you want me to

14 go on to the other chapters? Or that's all I

15 have about Chapter 1. If you want to ask the

16 other people or --

17 CHAIR SAMET: Sure, maybe --

18 DR. MILLER: -- you want me to go

19 --

20 CHAIR SAMET: -- it would be

21 easier to do it chapter by chapter, Fred, I

22 think.
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1 DR. RUSSELL: I don't really have

2 much to add on that, so --

3 CHAIR SAMET: On Chapter 1?

4 DR. RUSSELL: -- I mean, there

5 were some words -- to Chapter 1.

6 CHAIR SAMET: Right, Okay. And

7 Joe, Chapter 1?

8 DR. BRAIN: A couple of quickies. 

9 Even before Chapter 1 is a list of

10 abbreviations, which I like, but I think some

11 of them need links, like EvNA, Enhanced

12 Voronoi Neighboring Averaging is fine, but I

13 have no idea what that means. It would be

14 nice to have a link. MATS is a another one,

15 Model Attainment Test Software.

16 Also, I'm wondering whether there

17 should be a generic introduction preface

18 history that sort of comment to all of these. 

19 I like the one that's done for the REA.

20 I was also just wondering whether

21 the Chapter 9 should come earlier as it does

22 in the ISA? It was kind of nice having the
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1 integrated summary. Probably not. And then,

2 also, it does detail the history and one of

3 the things that seems conspicuous by its

4 absence is the role of CASAC in terms of the

5 reconsideration.

6 And, you know, we had meetings

7 about that and somehow, when discussing that,

8 it doesn't mention it. And then, again, I'll

9 also I'll bring up the PRB background issue. 

10 When considering the history, it seems to me

11 that ought to be mentioned as to when that

12 sort of took part in considerations and how

13 it fits into EPA deliberations.

14 CHAIR SAMET: Okay, good. Does

15 anybody else, why don't we just go through

16 the Chapter 1 and see if there are others who

17 want to comment on Chapter 1 and then we'll

18 circle back again. Yes, Ed?

19 MR. AVOL: Just a quick note to

20 reiterate to ask that you reexamine what you

21 list as the history. There have been several

22 comments about it, John, related to this
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1 morning. Particularly from Page 1-5, Page 5,

2 Page 6 in Chapter 1. And that is if you're

3 going to recount what the Administrator did

4 or didn't do, you shouldn't sort of interpret

5 what, what I would argue, you think he did or

6 didn't do.

7 There are comments in there about

8 what he recognized, what he placed more or

9 less weight on, et cetera. I don't know that

10 that is or isn't a part of the record. So I

11 think if you're going to import it, import it

12 as it was.

13 DR. BRAIN: Some of those

14 motivation ones are controversial.

15 MR. AVOL: Yes.

16 DR. BRAIN: Interpreted by others. 

17 Everyone's like, what did he say?

18 MS. WEGMAN: I'll just say that

19 that is actually directly from the notice. 

20 What's in there, comes directly from what was

21 said in the final rule notice.

22 MR. AVOL: And I think, as my
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1 other colleagues have said, that you ought to

2 put more of it there that, you know, CASAC

3 did or didn't do, et cetera. You know, lay

4 out the whole bit, not just sort of pick

5 pieces of it.

6 MS. WEGMAN: Okay. Thank you.

7 CHAIR SAMET: Chapter 1, anyone

8 else have comments? Fred, back to you.

9 DR. MILLER: Okay, we're going on

10 to Chapter 2 then. The chapter does an

11 excellent job of presenting information on

12 the sources of ozone in the various micro

13 environments. The types of health effects

14 that are suitable for inclusion in the risk

15 assessment and identifying the at-risk

16 populations.

17 So, overall, I think the chapter's

18 very good. I did have something I'd like to

19 bring up as a point for discussion, because I

20 don't quite get this. On Page 2-7, Line 14,

21 the authors talk about Concentration Response

22 functions in the case of epi studies and
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1 Exposure Response functions for controlled

2 human studies.

3 And if anything, to me, they're

4 both exposure response and if anything, the

5 epi studies could be called Exposure Response

6 and the controlled human studies

7 Concentration Response. And you use this

8 interchanging terminology throughout the

9 document.

10 That, and it's not clear and it

11 doesn't even agree with the International

12 Society for Exposure Analysis's 2005

13 publication by Zartarian et al, where they

14 defined what these different terms are

15 supposed to mean in studies. So, I am

16 baffled.

17 And when you have an ozone

18 controlled human study, you know it's ozone

19 in the chamber. It's a concentration of

20 ozone that's in the chamber, so I don't know

21 why you're calling it Exposure Response. 

22 This just escapes me.
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1 And in fact, so I know I'm only

2 from Wyoming and all that, but still, you got

3 to do a better job of why you're using and

4 making this distinction and calling one

5 Exposure Response and the other Concentration

6 Response.

7 Because the people are exposed to

8 a concentration of ozone. I don't care if

9 they're in their home, if it's an epi study,

10 or a controlled study, or it's an animal tox. 

11 It's a concentration of ozone. So you got to

12 do something to make that clear, because

13 right now it just doesn't come through to me.

14 And one of the other things that

15 is stated in here, and it's basically

16 correct, and that is that the controlled

17 human exposure studies are biased away

18 typically from highly susceptible

19 individuals. And while, in general, this is

20 true, there have been studies with various

21 at-risk sub-populations, like asthmatics,

22 COPD, subjects that have been in studies.
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1 So it's, to me, it would be better

2 to convey that it's not the norm to have

3 these others, but there is some information. 

4 And right now it comes across that it's just

5 automatically going to be biased. And so,

6 overall, I thought the chapter just, you

7 know, was a very good layout of everything. 

8 But I really would appreciate being

9 enlightened about exposure and concentration.

10 CHAIR SAMET: Okay. Ted?

11 DR. RUSSELL: Yes, I looked at

12 this and actually I don't think the chapter

13 lives up to the opening line of the chapter

14 where it's going to provide the conceptual

15 framework for assessing exposures and

16 associated risks.

17 And that I thought it laid out the

18 first part, so essentially ozone chemistry

19 and health effects, at-risk populations and

20 such. But not really giving an adequate

21 conceptual model or framework for conducting

22 the risk and exposure assessment, which you
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1 go into more detail in the scope. But I

2 still think that, if you're calling it a

3 conceptual model for the Exposure and Risk

4 Assessment, you need more of that within this

5 chapter.

6 So other than that, most of the

7 other things I have are little pieces that I

8 think are, you can pick up from my written

9 comments.

10 CHAIR SAMET: I mean, in fact, my

11 comments says not conceptual amount of

12 framework for the chapter. And I think that,

13 just to echo what Ted said, I mean, you have

14 a whole set of considerations here that are

15 relevant to the framework. But the framework

16 itself, to me at least, doesn't quite appear. 

17 Joe?

18 DR. BRAIN: Yes, I had the same

19 concern. It really doesn't advance the

20 argument. You know, it doesn't really tell

21 you how it's going to be done. And also in

22 that regard, again, 2.2 sources of ozone and
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1 its precursors. You'd think this would be an

2 obvious place to mention the role of

3 background and how it will actually be

4 deployed in a conceptual model, and that's

5 absent.

6 CHAIR SAMET: Okay. Other

7 comments to Chapter 2? Ed?

8 MR. AVOL: Just one comment, then,

9 saw something on the bottom of Page 2.7, or

10 2-7. There's a comment, Line 27/29, about

11 what controlled human exposure studies can do

12 and it sort of implies it. Well, it really

13 can't do much. It can only sort of check

14 whether you're breathing and if you're

15 upright and walking.

16 And I think it goes much further

17 than that. There are obviously much more

18 subtle inflammatory neurological cardio

19 events, a whole range of influence that had

20 been, can be, and are used. And I think this

21 belittles what actually is possible, and what

22 is being done.
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1 CHAIR SAMET: Any other comments

2 on Chapter 2? I have to say, I'm just sort

3 of eyeballing some things I'd circled here. 

4 And you might, I mean again, just prose such

5 as, population was greater portions of

6 individuals with characteristics associated

7 with higher risk for most of your exposure

8 are likely to have a greater risk from any

9 given level of O3. Tautology.

10 I mean, I just, it sort of, the

11 whole chapter sort of, and I won't read the

12 next sentence because it deteriorates. But,

13 again, I think it just goes back to this

14 important point about, you know, precision. 

15 Particularly around these concepts of at16 risk, I think it's really critical.

17 Okay, Chapter 3.

18 DR. MILLER: Well, and before we

19 go to that, I really interpreted what was in

20 Chapter 2 as, that the important factors, as

21 opposed to a framework, the concepts that

22 were involved in it. So I kind of just kind
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1 of let that slide. But I agree with you.

2 CHAIR SAMET: Yes, I mean, I think

3 you're right. I mean, it discusses those

4 elements that would go into framework and

5 then just doesn't quite take that next step,

6 which is I think what Ted was getting at.

7 DR. MILLER: Okay. So then moving

8 on to Chapter 3, which has to do with the

9 scope, the Page 3-8, Line 10, the authors

10 state that the CASAC recommended moving away

11 from using PRB in calculating risk.

12 And I bothered to include the

13 entire paragraph in my comments to remind you

14 that what we really were referring to had to

15 do with the things that, above 40 parts per

16 billion, are either many or indistinguishable

17 from linear. And that it was irrelevant to

18 need a PRB to use the science to say where

19 there are effects of ozone.

20 And that's different from saying

21 you're going away from incorporating PRB

22 eventually in analysis. Because, at the
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1 time, there was far less information about

2 the background levels. And so it was, I

3 didn't interpret it, and it also doesn't say

4 that it was a consensus view of CASAC,

5 because I certainly didn't endorse that we

6 not include that.

7 So there's some verbiage there

8 about it that basically is sort of pushing

9 the context of what CASAC actually

10 deliberated on in the way that you're ending

11 up using it now. And in that regard, the new

12 McDonnell study eliminates, you know, part of

13 the issues at the time in this aspect of no

14 threshold for FEV1 changes. That is clearly

15 not the case with the latest publication of

16 the threshold model.

17 In all of the models that they've

18 considered, the threshold coefficient was

19 statistically significant and they presented

20 it to aid the information criteria. And if

21 you look at the relative probability, it is

22 00.000027, or 1 chance in 36,310, that the
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1 No-Threshold Model is appropriate, which just

2 nails the coffin shut.

3 That FEV1 changes do have a

4 threshold and that model proves it. And it

5 uses 700 and some individuals and 11,000

6 measurements. It's as robust as you could

7 ever get. And it will impact, greatly, the

8 way that you implement this risk assessment.

9 And so while you talked earlier

10 today about the 2010 paper, to me, that's a

11 thing of the past. And this paper has just

12 rock solid. And I certainly hope you plan to

13 use it.

14 In here in this chapter 2, in

15 terms of the scope, you talk about the LML's

16 and also down to zero. And I personally

17 don't favor going down to zero, although I

18 can see an argument for it. But in the

19 description of the use of the LML's, I don't

20 see a value of using it unless you do get the

21 city specific data that you talk about for

22 the LML's and whether or not you could
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1 obtain, you know, getting that data.

2 So that, to me, is a critical

3 factor, because in addition, as I looked in

4 the ISA with the new information on the

5 seasonal and the regional North American

6 background, U.S. background, and so on.

7 I absolutely did not see a reason

8 why you wouldn't end up with a city specific

9 risk analyses, taking into account the

10 regional heterogeneity that exists in the

11 background levels. To me, the days are over

12 that you take one national value and do any

13 kind of analysis.

14 So given that, and then since you

15 have done these city specific analyses so

16 far, I hope that you'll be able to get an

17 either an appropriate surrogate or to be able

18 to get the values from the investigators. Or

19 whatever you eluded to, the fact you would

20 have to try to track those down.

21 So the epidemiology studies in the

22 discussions here, you know, are not able to
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1 define a threshold for ozone for the

2 mortality, the hospital admissions, and the

3 other effects. It doesn't mean that a

4 biologically effective threshold does not

5 exist.

6 And so we're really down into this

7 gray area here of interpreting. And this is

8 where some of the things that came later,

9 where talked about separating for the,

10 there's only one epi study that the dose

11 metric was below the current standard. And

12 that was the Koenig Study at 0.071.

13 And you talk about then dissecting

14 the population, or the ozone concentration

15 response curves, for the different

16 percentiles for some of the other studies. 

17 So I provide later some comments on about how

18 you might do that. And that becomes

19 important in looking at that segment of the

20 distribution in your heat maps and how you're

21 shifting this down later.

22 So it seemed like that there was a
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1 good probability that the LML's will often be

2 lower than the North American backgrounds in

3 that. And so the national map of the NA

4 levels are available as model outputs. And I

5 would hope that then they are used also in

6 the national risk assessment.

7 I couldn't tell from the write up

8 if they were, so far, but I think you have

9 the opportunity to use them. So those are

10 the main things I had on the chapter.

11 CHAIR SAMET: Okay. Ted?

12 DR. RUSSELL: Not much to add. 

13 Just in my reading through it, I think that,

14 you know, after reading this chapter, it laid

15 what was going to be done through the rest of

16 the REA. One thing I was hoping to see a

17 little bit more in this chapter was a little

18 bit more about the why. Such as why do you

19 chose APEX, why do you choose BenMAP, et

20 cetera, to sort of give us an idea, the

21 foundation for the thinking.

22 I will also pick up on what Fred
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1 said, is that, you know, here, and I think

2 elsewhere, the use of LML as sort of the

3 upper bound is not that well supported. And

4 I was looking to have more, again, the why is

5 that choice best and why is it, you know,

6 just I think that needs to be further

7 developed if that's going to be your choice.

8 CHAIR SAMET: Okay. Joe?

9 DR. BRAIN: I'm still troubled by

10 the overall organizations of Chapter 2 and 3. 

11 In fact, some of the, you know, the title of

12 Chapter 2 describes some of the stuff in

13 Chapter 3. Finally I got to the end of

14 Chapter 2, if you look at Page 3-22,

15 presentation of risk estimates to inform the

16 ozone NOx policy assessment. I love that,

17 because it was simple, it was

18 straightforward.

19 First paragraph, we plan to

20 conduct the risk assessment in two phases. 

21 They say what they are. Next paragraph, we

22 present risk estimates in two ways, total
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1 absolute health affects; two, risk reduction

2 estimates. Third paragraph, we present an

3 array of risk estimates in order to provide

4 additional context for understanding, et

5 cetera.

6 So it seemed, you know, that sort

7 of brief description of what is the process,

8 and what's the goal, and what are the

9 outcomes, it seems to me, ought to be present

10 earlier. And then perhaps add kind of an

11 explication of how you did those different

12 things.

13 But again, I sort of found myself

14 kind of really not knowing where it was

15 going, what part of the process was being

16 described. And finally, at the end, I found

17 this, you know, really nice, crisp, road map. 

18 So I think it somehow needs to be clearer.

19 Again, I don't understand all the

20 issues of, you know, going to zero or the

21 LML. I think I have a preference for the

22 LML. You know, zero really has no value
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1 since we can't influence those very low

2 levels by the regulatory process. And we

3 really have very little data.

4 Maybe I'm missing something, but I

5 don't really understand the value of the CR

6 function that goes down to zero. So my

7 preference was for the LML.

8 CHAIR SAMET: Anything else, Joe? 

9 Okay. So, yes, and it seems to be -- Bryan,

10 that the text that Joe is pointing to is at

11 least a start on that list of things that you

12 want to get accomplished, that need to be

13 accomplished.

14 One other quick comment, there's

15 text here on uncertainty and variability in

16 this chapter that is replicated in at least

17 three or four of the other chapters word for

18 word. Just do a word search, but it just

19 carries through. I read the same definition

20 of uncertainty and variability over and over

21 again.

22 So other comments here, Fred?
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1 DR. MILLER: We'll start getting

2 into it now, in Chapter 4 and that beyond,

3 but I think I'd like to remind us about the

4 amount of duplication between the policy

5 assessment. And that as we go through these

6 next chapters where there really is more of

7 this, to kind of keep in mind, as we might

8 formulate, what might be our recommendation

9 in that regard.

10 CHAIR SAMET: Okay. Other

11 comments here on Chapters 1, 2, and 3?

12 DR. HUBBELL: John, I was

13 wondering if I could --

14 CHAIR SAMET: Sure, Bryan.

15 DR. HUBBELL: One recommendation

16 that Fred just made was to incorporate the

17 results from the McDonnell 2012. And I was

18 just going to, again, to link that back to

19 this morning's conversation about, you know,

20 having that referenced in the ISA.

21 If that's something that you feel

22 is critical for us to do in the REA, it's
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1 also going to have to be something that's

2 referenced in the ISA, so that we can bring

3 that forward. So I just wanted to bring that

4 up.

5 CHAIR SAMET: Okay.

6 DR. MILLER: I'll be sure it's

7 there.

8 CHAIR SAMET: Okay, so any other

9 comments on these first three chapters? Okay

10 then we're on to --

11 FEMALE PARTICIPANT: Lead writers?

12 CHAIR SAMET: Oh, lead writer. 

13 Fred, do you want to be the lead on this one?

14 Is he already a lead?

15 DR. MILLER: I'm sorry, what?

16 CHAIR SAMET: Let's see, well,

17 obviously we need a lead on this. We're

18 going to have some replication. Ted, have we

19 volunteered you for something yet?

20 Oh, how about being lead on

21 Chapter 1 to 3 here, to spare Fred?

22 DR. RUSSELL: Congratulations.
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1 CHAIR SAMET: Okay. Let's see, on

2 to air quality. George?

3 MR. ALLEN: Thanks. Chapter 4. 

4 Going over some of the key charge questions

5 here. The first one was really dealing with

6 the years of the air quality data. And there

7 were two overlapping three year periods, 2006

8 to '08 and '08 to 2010.

9 And this actually came out of a

10 meeting that we had a year ago, almost a year

11 ago, on the scope and methods planned. Where

12 we looked at it and said, well, it's nice to

13 use the most recent three year data that are

14 available. But on the other hand, at least

15 in the eastern U.S., 2009 and 2010, were odd,

16 '09 was truly the year without a summer, in

17 the northeast at least, and '09 and '10 were

18 cleaner than usual.

19 And certainly this summer, '12,

20 has reinforced that point, that those are not

21 normal years. So I think that plus, and I

22 believe GEOS-Chem most recent runs are
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1 available only for '06 to '08, is my

2 understanding. And you really want to

3 synchronize those things.

4 So I think that was one of the

5 reasons why doing those two overlapping

6 periods came to be. And I think that's a

7 good idea. So I think that's an appropriate,

8 a little unusual, but I think it's

9 appropriate given where we find ourselves

10 right now.

11 The next big question is the

12 change in rollback methods. A minor change

13 to the quadratic rollback is putting in that

14 floor with a lower bound. But the really big

15 change is going, the talk, discussion, of

16 going to the higher order, direct coupled

17 method, the so called CMAQ HDDM approach,

18 which is a very big change. Potentially a big

19 improvement.

20 It's my understanding, and please

21 correct me if this is wrong, but it gets away

22 from the need to have an estimate of any kind
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1 of a background, natural background. Or, if

2 you prefer, unnatural background. It gets

3 away from that whole problem, which we spent

4 half the morning discussing.

5 And there are quite a few examples

6 of how it works and what it can do. It

7 certainly looks like it has the advantage of

8 taking local chemistry into effect. The

9 standard, the quadratic rollback approach,

10 all the sites, the ranking doesn't change.

11 Whereas the HDDM takes local

12 chemistry into account. If you have more NOx

13 versus more VOC reductions, some sites will

14 go down more than others and the ranking

15 could change. And they give some examples

16 for Atlanta and Detroit. And especially for

17 Detroit, they give different scenarios for

18 NOx and VOC reductions.

19 So I think it has the potential to

20 be a substantial improvement in a smarter

21 rollback approach. But it does rely on

22 having good input, in terms of emission
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1 inventories, that are useful in terms of the

2 temporal and spatial scale.

3 If you're talking about a large

4 urban area, are those inventories for NOx and

5 VOC's, and speciated VOC's potentially,

6 because they're not all the same. Are those

7 going to be available and sub-daily? We're

8 talking diurnal issues here. Things could

9 get very complicated and kind of ugly really

10 fast.

11 So I think it's a great concept,

12 but I think it needs to be test driven. But

13 the second, I believe it's being proposed,

14 that the HDDM will be used in the second

15 draft of the REA. I think it needs a lot

16 more test driving.

17 And I think it was discussed

18 earlier, that perhaps both should be carried

19 forward for the present time for comparison

20 purposes. And that might not be a bad idea.

21 Again I'll say that I think it

22 really has potential to do a lot better job. 
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1 And to respond to some of the differences in

2 the local chemistry. I think it remains to

3 be shown whether or not it can actually do

4 that in a useful way.

5 I think that it's for me.

6 CHAIR SAMET: Okay. Daniel?

7 DR. JACOB: So I think we've heard

8 speaker after speaker say that HDDM was a

9 favorable method over the quadratic rollback. 

10 Although there may be some issues about

11 robustness. I totally endorse this. I think

12 that we really should be going to the HDDM

13 method.

14 As a matter of fact, the really

15 precise way to do this would be with a CMAQ

16 adjoint, where you could really be precise as

17 to the granularity of the mission controls

18 that would just meet the standard. But I

19 understand the adjoint is not mature and HDDM

20 I think would be just fine for this

21 application.

22 We heard about the utility of
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1 maintaining the quadratic rollback as a way

2 to have continuity with previous assessments. 

3 Except that the quadratic rollback here is

4 not going to be applied in the same way as

5 before.

6 And I was rather concerned about,

7 if a way that it would impose a background on

8 the basis of base to background ratios in

9 GEOS-Chem. That kind of made my eyebrows

10 arch.

11 I would much rather use a

12 background for GEOS-Chem, than to constrain

13 the base to background, since the errors of

14 the base and of the background are probably

15 not correlated.

16 All right. So this is just an

17 endorsement of using HDDM in the second draft

18 of the REA. I just have a few more comments

19 about the way that the ozone concentration

20 fields are specified. For the urban

21 applications, I have two things that I

22 thought were puzzling.
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1 The first one was the exclusion of

2 exceptional events. You know, if we follow

3 Bryan's point that ozone is ozone, well, you

4 know, why remove the exceptional events from

5 the database? You'd say, well, once we want

6 to remove natural background contribution,

7 sure, remove the exceptional events too.

8 But, anyway, there should be, it

9 wasn't clear to me why you would remove the

10 exceptional events right off the bat. And if

11 there's a reason for that, there should be

12 some justification.

13 The other one that I was a little

14 puzzled about was, why take an average ozone

15 concentration across each urban area? 

16 Because, presumably, exposure differs

17 depending on where you are and you're in the

18 area in the population distribution. And I

19 didn't see the need for averaging the ozone

20 concentration of scaled city. Maybe there is

21 a reason, but it just should be explained in

22 the document.
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1 With regard to the national

2 distributions, I was a little concerned about

3 the data fusion method. Well, I was confused

4 over the figures, but there was a typo in the

5 description of the figures, so that's fine. 

6 Still, there's some features in those maps of

7 ozone concentration, national scale, that are

8 pure CMAQ product.

9 Like, for example, the far

10 influences in Idaho, which I, for one, don't

11 believe, because we've done analysis of ozone

12 concentration at Glacier National Park, right

13 next to those fires, and we don't see those

14 big ozone plumes.

15 But that's, the point is that

16 there's different levels of confidence, I

17 think, in those national ozone distributions

18 depending on how far you are from ozone

19 monitors. And how much information you have

20 from the observations, versus from CMAQ.

21 And I would make two requests. 

22 The first one is that we getter some better
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1 assessment of the quality of this data

2 fusion. And this must have been, this must

3 be in the papers that are referenced in the

4 document. It would be nice to have that

5 given in the REA. So I won't have to go to

6 that original reference.

7 And the second thing that I just

8 put up for consideration is that, if we have

9 different levels of confidence on the ozone

10 concentrations, depending on the level of

11 information provided by the observations,

12 perhaps there could be some error weighting

13 in the exposure that you derive from those

14 national estimates.

15 So these were my comments.

16 CHAIR SAMET: Okay, thanks. 

17 David?

18 DR. CHOCK: Yes, talk about

19 question number 5 and agree with Richard

20 about drought and about the extent of the

21 years from 2006 to 2010. And I also consider

22 that 2008 to 2010 period to be important,
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1 because it reflects some events that may

2 become more and more commonly saw, like a new 

3 -- drought conditions that -- so you can get

4 a preview of what may be happening in the

5 future.

6 So I consider 2008 to 2010 to be a

7 very important period as well for

8 consideration. For the charge question

9 number 6, regarding the quadratic rollback

10 issue, I don't think it is really an

11 appropriate approach, because it doesn't

12 really base on, it's not based on science.

13 And also there's actually an

14 important distortion. I don't know how many

15 of you actually notice it. If you look at

16 Table 4-1 and Table 4-2, especially Table 4-

17 2. You look at the design values for the

18 2006 and 2008 period, you know, two cities

19 come out like a sore thumb, namely Los

20 Angeles and Sacramento.

21 They both have very high design

22 values and both cities run into a problem of
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1 having the very high percent replaced by the

2 floor values. So that means that the

3 concentrations below the highest value tend

4 to be squeezed down considerably, especially

5 for those that do not hit the floor value.

6 So that's really a distortion of a

7 certain portion of the ozone concentrations

8 and it can lead to a distorted view that, you

9 know, just reading this handout may actually

10 be very beneficial. Except it not really

11 necessarily true. Too beneficial then

12 necessary. So I consider that to be totally

13 inappropriate.

14 So I really recommend that the

15 quadratic rollback approach to be abandoned

16 and I certainly support the use of HDDM. And

17 there's also a side benefit, perhaps, in the

18 control phase, by using the HDDM, because it

19 may provide some indication of what ought to

20 be controlled on a regional basis. So they

21 may lead to some kind of more effective and

22 economical control.
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1 There are two, at least two issues

2 or two concerns on the HDDM case. One is the

3 application of the sensitivities to the

4 monitor concentration, rather than the model

5 concentration.

6 I understand this is the general

7 approach in the relative response factor

8 method, but the issue is when you apply this

9 to the future years we will never be sure

10 whether this approach is appropriate. In

11 fact, Chris Emery already pointed that out.

12 And the second concern I have is

13 the multiple possibility of choices. Do you

14 want control NOx only, or VOC only, or NOx

15 and VOC combination? And it may lead to

16 different results. So there of plenty of

17 options available. But still, scientifically,

18 I highly recommend that approach to use.

19 In terms of the national database,

20 we are talking about using the new approach. 

21 I wonder why the EPA abandoned the old

22 approach. I think that was definitely a more
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1 satisfying approach. Of course it may be the

2 money is too high, and I can understand why

3 EPA would abandon that, but that's all I

4 have.

5 CHAIR SAMET: Okay. Thank you. I

6 want to just go on, but there seems to be

7 some range of opinions about preservation of

8 the quadratic rollback versus the HDDM. And

9 I don't know whether we need to sort of have

10 maybe have a little more discussion on that

11 point.

12 Ed, did you want to comment on

13 that one? Or I just wonder if we can have a

14 little bit of a dialog about that point. I

15 mean, we heard from David, I think the

16 strongest opinion about the quadratic.

17 And then maybe the, it seems like

18 now it's being offered as sort of a point of

19 sensitivity analysis or comparison for now. 

20 So, comments? Okay, Ted?

21 DR. RUSSELL: I'll just put in my

22 two cents worth, is my one concern about
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1 carrying the rollback approach forward is,

2 you know, it's going to add to the time,

3 which is already short. In terms of the type

4 of analyses.

5 I think we've all agreed that, you

6 know, and I've given this some thought how

7 HDDM might be used in such a thing. Is that

8 it is scientifically, I think, more

9 appropriate. It does introduce some

10 additional -- you have to give it more

11 thought.

12 And I was going add that going

13 forward with HDDM, it does put more

14 importance on model evaluation, which has to

15 be addressed. And then, as David said, you

16 also have to discuss the idea of implications

17 of applying it to observation, but I don't

18 think that adds much in terms of how you

19 support the use of HDDM.

20 So in terms, you know, I don't

21 see, I mean, I've never been a fan of the

22 rollback analysis, because it does not
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1 capture what's happening at the lower ends of

2 the ozone distribution. When you start,

3 "controlling" things, is that some of the

4 lower ozone levels will come up, which does

5 bias your health analyses.

6 So I'm more in David's camp that

7 it's -- I don't think we want to request that

8 they move forward with it and spend the time

9 doing it, given its limitations.

10 CHAIR SAMET: Okay. Bryan, do you

11 want to comment here?

12 DR. HUBBELL: Well, the only

13 comment I want to make is that, you know, it

14 is time consuming to do these analyses. And

15 doubling, essentially, the number of analyses

16 we do would be very difficult, given our

17 schedule.

18 And so, obviously, if the panel

19 feels strongly that we need to keep a

20 reference point, it may be helpful to think

21 about, is there one analysis that would be

22 useful to do a single quadratic rollback to
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1 show a reference point or not. But doing it

2 on every analysis would be very, very

3 difficult.

4 CHAIR SAMET: Okay. Sverre?

5 DR. VEDAL: Just a small point

6 from what I heard, is everybody sure that the

7 inputs are available for doing the HDDM?

8 CHAIR SAMET: Bryan?

9 DR. BROWN: Yes, they are

10 available to do the inputs. There are

11 obviously, and again, I'm assuming that, you

12 know, if you want details we can get into a

13 little bit more of this, but the analysis

14 presented in the Simon et al paper was based

15 on looking at two cities. We do have the

16 information to do other cities.

17 The specific application and the

18 method by which we would reduce emissions,

19 obviously if you get into more refined

20 emissions sectors or locations, the detail

21 that is needed to do those modeling runs is

22 more difficult to work with. What we've done
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1 now is focused on domain-wide NOx and VOC

2 reductions. And there are reason for that,

3 and we can go into that if you'd like more

4 information.

5 But that is our current plan, is

6 to use region-wide, the domain-wide NOx and

7 VOC reductions in different combinations. At

8 this point, we've looked only at NOx and only

9 VOC separately. And we have not yet

10 validated the model for doing combinations of

11 NOx and VOC.

12 And again, we can provide more

13 information to the extent you want more right

14 now. We can talk about that, but the

15 feasibility of doing something more than just

16 a domain-wide reduction to target individual

17 locations.

18 Number one, I'm not sure of the

19 utility of doing that, and I can talk to you

20 about why. And two, I'm not sure of the

21 feasibility of doing that without having to

22 get into specifying specific control
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1 strategies, which is really not the purview

2 of the REA.

3 And we've been trying to avoid

4 specifying specific control scenarios,

5 because that gets more into implementation.

6 CHAIR SAMET: Okay. Fred?

7 DR. MILLER: Could you comment on,

8 one of the public commenters indicated that

9 you would not be able to evaluate the

10 contribution to risk of from any kind of

11 background, because it's endogenous as a

12 module? I would like to understand if that's

13 correct.

14 Because I would think that you

15 have, from these regional maps, that you can

16 have independently a statement of, we're

17 going to now aggregate on the concentration

18 response curve all the risks above X PPB. 

19 But my endorsement and favorability of going

20 the way that you're talking, is clearly

21 dependent on its impact back to the risk

22 analysis.
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1 So can you elaborate a little bit

2 on what can and can't be done and the

3 limitations?

4 DR. BROWN: The specific HDDM

5 approach would not prevent us from using

6 background concentrations to be able to do a

7 risk assessment. Again, that's a, you know,

8 a separate issue as to how that would be

9 specified and so forth. But, and I'm turning

10 to my modeling person, Heather, there's no

11 reason why we couldn't construct a background

12 case that we would then use as a reference

13 point, correct?

14 MS. SIMON: Right, and we could

15 either --

16 DR. BROWN: You've got to come up.

17 CHAIR SAMET: Yes, please come up

18 to the microphone.

19 DR. BROWN: You may take my

20 podium. Introduce yourself.

21 MS. SIMON: I'm Heather Simon and

22 I think that the way in which HDDM eliminates
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1 background is that we no longer need a set

2 and a kind of an artificial floor for our

3 rollback. Because the model explicitly

4 calculates the sensitivities, taking into

5 account all sources, including background

6 sources.

7 But in terms of the risk analysis,

8 we could use background values either from

9 the literature or it would be possible to do

10 a CMAQ run using our same inputs without any

11 of the anthropogenic missions to say what our

12 model is predicting background. That would

13 be possible, although we have not analyzed

14 that at this point.

15 CHAIR SAMET: Just another comment

16 before you quite leave. Would it be

17 possible, I think, within the document, I'm

18 sort of thinking about what guidance we might

19 give. But also for you to give a very clear

20 and explicit description of comparison of the

21 two approaches and setting out why you are

22 choosing to do the HDDM.
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1 I don't think that's, unless I

2 missed it, this is way outside my expertise. 

3 That it's there in a way that, you know, that

4 the naive reader can come to the document and

5 say, okay, here's why they're making a

6 change, here's why a new choice has been

7 made. And I think that needs to be there.

8 I think our comments on this,

9 which, George, perhaps you could summarize

10 for Chapter, whatever it is, 4. I think it

11 should reflect that there was some range of

12 committee view points about this, but perhaps

13 that a preference could be given for a number

14 of reasons, including feasibility, to

15 selecting a single approach. Fred?

16 DR. MILLER: I do favor the

17 possibility though of having one example of 

18 a comparison --

19 CHAIR SAMET: Sure.

20 DR. MILLER: -- of the quadratic

21 to that. And maybe picking, based upon what

22 you feel of these different cities, and that
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1 is, is it would be most reflective of

2 demonstrating the changes. Because I think

3 that continuity over, for interpretation,

4 would be good. But it would be a very

5 limited thing, not the broad use of it.

6 So I think that someone brought

7 that up and I think it's a reasonable point.

8 CHAIR SAMET: Okay. Yes, I think

9 Ted, or actually I think even Bryan raised

10 that possibility. So I think that would be

11 useful. Anything else on Chapter 4? Yes,

12 Chris?

13 DR. FREY: I have an observation,

14 I guess, I mean, it sounds like the model

15 based rollback is, you know, the

16 scientifically preferred approach. But it's

17 also in some sense, it's a higher risk

18 strategy at this stage. Because we haven't

19 seen one in the first draft REA.

20 So as a panel, we'll see it in the

21 second draft REA. And I certainly wish you

22 all well and hope you anticipate all our
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1 comments, but I mean, I think it's risky in

2 that regard. And I just make that as an

3 observation.

4 I think maybe it's just a call to

5 be dually diligent to address the issues Ted

6 mentioned, and others, that, you know,

7 predictably we're going to comment on. If

8 you can anticipate that and read our minds. 

9 Because otherwise I'm concerned we're going

10 to start thinking about a third draft REA, if

11 it doesn't turn out in a well written, clear

12 way that makes sense.

13 So I think that's just a risk.

14 CHAIR SAMET: Okay. Anything else

15 on this chapter then? Okay, George, if you

16 could take on the role of summarizing? So

17 let's go, I think we have 15 minutes, let's

18 do as much of Chapter 5 as we can. And since

19 I understand we really do need to be out at

20 5:00, if we need to come back to this

21 tomorrow, that's just fine. So, Helen?

22 DR. SUH: Okay, so I'll just go
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1 through this quickly. So commenting on

2 Chapter 5, there were three groups, really,

3 of questions.

4 First was on the methods of the

5 population exposure assessment. I thought it

6 was, the methods were described, and I guess

7 the overall approach was sound. However, I

8 thought it was very complicated and suffered

9 from some vagueness at parts. And I think

10 that the vagueness might have to do with how

11 complicated it was to explain, all the

12 intricacies of the model.

13 I think the chapter would be

14 improved with maybe an overall, a figure of

15 the APEX approach. Just schematically, like

16 maybe a flowchart of how it goes through its

17 calculations. I think the vagueness was

18 particularly apparent in maybe, you know,

19 three or four ways.

20 One was a description of the

21 uncertainty analysis, which you'll talk

22 about, because that was the third set of
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1 charge questions.

2 Another one was the description of

3 the model performance. So the citations were

4 for an earlier version of the APEX model. In

5 the text, there was basically this statement

6 that said, it was significantly improved in

7 these ways. But there was really no

8 indication of how improved, how much

9 improved, and really how well the model did

10 perform overall.

11 So it would be, I think, helpful

12 to include maybe some more quantitative, or

13 better description, of the improvements to

14 the model and how it improved the overall

15 performance.

16 A third aspect was in this

17 description of the methods to do multiple,

18 repeated exposure analyses. I think that was

19 described later on in Page 5-51. And there

20 was a good description of what was limiting

21 about the ability right now to do the

22 repeated exposure assessment, I guess the
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1 longitudinal exposure assessment.

2 And then they say you would

3 approve on it in the next assessment, but I'm

4 not really sure how you're going to do that,

5 given the limitations of the data sets and

6 the limitations that were cited. So it seems

7 very much like a black box to me.

8 The other two things that were not

9 really related to the vagueness, but, well,

10 one was the figure, but the other one was

11 really in the databases and their age. I

12 know that the activity databases, you know,

13 there was a nice table that describes the

14 activity databases, but it was clear that

15 they were very old.

16 Most of them were, you know, some

17 of them were over two decades old. And then

18 the ones that were focusing on children were

19 relatively few. So it would be, I think,

20 helpful to include maybe of all those data,

21 how much really focused on children.

22 And then a discussion, there's
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1 nothing, I guess, we can do about the age of

2 the data sets. But maybe a discussion of how

3 activity patters may have, I mean, maybe it's

4 too much speculation, but something to

5 acknowledge the age and how activity patters,

6 especially given the, you know, all the

7 mobile devices and the electronics, how

8 activity patters, especially for children,

9 may have changed substantially during this

10 period.

11 And so the, I think the discussion

12 would have been enhanced with some discussion

13 of the relevance of those data sets to

14 current. You know, and it was brought it up,

15 I know, in the uncertainties and everything

16 like that, but it would be good to, I think,

17 to have that discussion again.

18 With regard to the description of

19 the results, I actually was very confused. I

20 read it many times, looking at the figures,

21 and it was just last night that I think I

22 figured it out, that the figures and what
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1 they meant.

2 So I think maybe some more

3 clarification of what the results are would,

4 what all those figures are, would be a little

5 bit better. Rather than sticking it all at

6 the front and then having, just listing all

7 the figures and tables, subsequent, would be

8 good.

9 Also, along with that is, there

10 really wasn't any discussion of the tables

11 and the figures. They were just provided and

12 then there was no discussion of what all this

13 meant. So I think the, you know, basically

14 the presentation of the results could be

15 enhanced with some text. You know, just a

16 short summary.

17 And in fact, a lot of those short

18 summaries I found later in the PA, so it

19 might be good to just think about putting

20 some of that in here as well.

21 And then quickly, just about the -

22 - oh, you know, I liked section 5.6.1, a lot. 
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1 I thought it was really good, but I wasn't

2 clear how that would come into play in the

3 PA. And also in terms of the uncertainty

4 analysis, because those results seemed to

5 have an impact on the uncertainty analyses. 

6 And I just wasn't sure how.

7 And finally, the last group of

8 charge questions had to do about

9 uncertainties and variability. I mean, it

10 seems fine. I thought that what was discussed

11 there seemed totally appropriate. But it was

12 just not clear how that was going to be done.

13 You know, there was a listing of

14 what was going to be examined, but now how

15 that was going to be examined. So I guess

16 for the second round it will be discussed,

17 but, you know, I think it just needs more

18 elaboration.

19 Also, I think averting behavior is

20 going to be incorporated in the uncertainty

21 analysis is my guess? No? So otherwise, I

22 guess, you know, I thought the averting
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1 behavior was really interesting. I'm just

2 not sure what it's going to be, if it's not

3 in the uncertainty analysis, I'm not exactly

4 sure where it's going to go.

5 Like what those results are going

6 to add. And I thought it was a good, really

7 good analysis, I just wasn't sure what you

8 were going to do with it.

9 DR. HUBBELL: It's part of the

10 qualitative uncertainty analysis, in the

11 sense of characterizing how -- it's

12 characterizing two things. One, how likely

13 we are to over or underestimate exposures

14 using APEX diaries, which include diverting

15 behavior.

16 But the second part is to help

17 inform characterization of the epi results in

18 terms of noting that there is an

19 overstatement of exposure in the epi studies. 

20 And therefore you're biasing your,

21 essentially biasing the epi studies.

22 DR. SUH: So the uncertainty
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1 analysis is going to have a qualitative

2 component and a quantitative component, is

3 that, no?

4 MR. LANGSTAFF: Well, it's mostly

5 qualitative, actually.

6 DR. SUH: Mostly qualitative.

7 MR. LANGSTAFF: And some

8 sensitivity analysis.

9 DR. SUH: So the sensitivity

10 analysis, is that --

11 MR. LANGSTAFF: That's sensitivity

12 analysis, not necessarily uncertainty

13 analysis.

14 DR. SUH: So they're the same, the

15 sensitivity and uncertainty analyses, or are

16 they separate?

17 MR. LANGSTAFF: No, they're

18 different. In the sensitivity analysis you

19 might vary something by 10 percent or

20 something to see how --

21 DR. SUH: So that was when you say

22 you were going to --
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1 MR. LANGSTAFF: -- the influence,

2 but that's different than sort of assessing

3 the uncertainty of it.

4 DR. SUH: Well, I think maybe that

5 could be clarified or somehow in the second

6 draft, maybe have that be very explicit? And

7 then even if it's a qualitative, I understand

8 why it's qualitative and why it can't be

9 quantitative, but it might be, I guess I'm

10 just not sure exactly.

11 I mean, it's such an important

12 part of this, you know, exposure assessment,

13 this uncertainty analysis. Especially given

14 some of the issues regarding the age of the

15 data, all these other things. I think it

16 would be, I guess I feel like it should be,

17 it's just not clear what's going to happen

18 with it.

19 And I think these are really key

20 parts that, just some really, some good

21 thought has to be put into how, you know,

22 what's going to happen.
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1 MR. LANGSTAFF: That'll be one

2 thing it would be good to get some feedback

3 on, because right now we're up to vying to do

4 a qualitative analysis.

5 DR. SUH: It's sort of like, well,

6 maybe what I'll do is expand on some, because

7 I had some ideas, I just didn't know if they

8 made sense. And maybe we could just talk

9 about it or I could put them in my comments.

10 CHAIR SAMET: Okay. Michelle?

11 DR. BELL: Okay. So Helen and I

12 are on exactly the same page, in terms of our

13 read of this document. There were a lot of

14 places where it was really hard to evaluate

15 whether I thought the method was appropriate

16 or not, because the methods weren't very

17 clearly described.

18 But given the quality of EPA's

19 documents, I suspect that they are

20 appropriate and it's just an issue of

21 clarification, rather than there being any

22 problems with the methods. But that said, it
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1 was kind of hard to describe.

2 So I'm going to just go over big

3 themes and then I have more detailed comments

4 submitted. And I tried to give some specific

5 examples. Rather than just say, you have

6 vague language, I tried to put in some

7 specific examples of what I mean. I also

8 suggested a flow chart.

9 And the uncertainty analysis was,

10 it was clear a lot of thought had gone into

11 this issue, which I really appreciated, and

12 maybe it's just too early to know all the

13 details, but I think what I would do is

14 explicitly state, these are ones we're

15 quantifying, these are ones we're qualifying.

16 These are ones we think are

17 uncertainties, but we can't even actually

18 make an assessment on which direction the

19 uncertainty would push it. And that could be

20 a table or however you want to do it, but I

21 think that would be really useful.

22 So even for uncertainties where
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1 you're not going to incorporate them

2 quantitatively, if you could say we

3 anticipate, you know, this type of impact on

4 our results. And so sometimes, you know,

5 uncertainties are mentioned, like omitting

6 outdoor workers, but it's not clear what the

7 analyst thinks that means for the results.

8 Again, for the sensitivity

9 analysis, a lot of the methods aren't

10 specified, but I think they will be later on. 

11 Just in general, there's a lot of vague

12 language, and this is going to be just

13 something you need to fix in wording. But

14 things like, you can't say ozone season

15 without telling us what you mean by ozone

16 season.

17 So, in EPA it may always mean the

18 same thing, but the scientific literature

19 doesn't. And when you talk about, like, you

20 know, just meeting the current standard,

21 well, I could come up with 10 different ways

22 you would quantify that. And so I'm sure EPA
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1 has something specific in mind, but we could

2 just put it down. I have a few other general

3 examples.

4 Just two other quick points. This

5 chapter would really benefit from more

6 references and citations. I mean, I hesitate

7 to always be asking for expansion, but I

8 think that there's a lot of places here, like

9 where you describe the different ozone

10 benchmarks and actually give the rationale

11 for it.

12 But, you know, we can tell the

13 references behind that. And that would be

14 really helpful and that would go a long way

15 towards this clarification issue. And also,

16 it would be very doable.

17 And my last point is I also found

18 the figures a little bit confusing. I

19 actually gave some specific examples in here

20 where you might consider consolidating

21 figures. And part of it is the presentation

22 of the results.
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1 It's almost messy the way, like,

2 abbreviations are done. Like there's a, like

3 an abbreviation of 6-8 for 2006 to 2008 in a

4 figure. Like you could just put 2006-2008. 

5 And so I was able to figure out what you

6 meant, but I, you know, we don't want the

7 reader to spend extra time figuring that out.

8 And so I'll just leave the rest to

9 be my detailed written comments. But overall

10 I thought it was a good direction. It just

11 needs some work on the wording and

12 clarification.

13 DR. HUBBELL: If I could ask for

14 one clarification too, is one thing to keep

15 in mind as you're making your comments, is

16 that for the next draft we're going to have

17 16 cities. So think about multiplying all

18 those graphs out.

19 And we're looking for any ideas

20 you might have on -- when you say

21 consolidation or if you think of the summary

22 figures that you'd like to see, that would be
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1 helpful. Because it's going to be a lot of

2 data to condense.

3 DR. BELL: Yes, so I think, okay,

4 that's true. So to think that's something

5 really even more important then.

6 DR. HUBBELL: We'll do our best,

7 but if you have ideas, that would be great.

8 DR. BELL: Okay.

9 CHAIR SAMET: So why don't we hear

10 from Ana, and then what I'm going to suggest

11 is after that, we return to this topic

12 tomorrow to see if there are other issues to

13 discuss.

14 DR. DIEZ-ROUX: Okay. So in terms

15 of the first question, which has to do with

16 the methods, the major thing I wanted to

17 raise is the time activity diary data. 

18 Because it seems to me that the exposures

19 estimate are going to be highly dependent on

20 the time activity data.

21 And it's not clear, there's very

22 little discussion of how representative these
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1 samples are of what populations are actually

2 doing in these places. And I think that's,

3 at least that has to be acknowledged a little

4 bit more up front.

5 Perhaps you could even show some

6 descriptive data of the studies that tell us

7 something about, you know, the SCS

8 distributions, the occupation. You know, but

9 because there's so much interindividual

10 variability related to that, that at least

11 acknowledging and describing that would be

12 really important.

13 And in particular because I think

14 it's likely that there's a lot of

15 interindividual variability in time activity. 

16 And that could lead to big difference in

17 exposure. And particularly for, you know,

18 there may be very high exposure in some

19 groups and very low in others.

20 And the very high exposure may be

21 concentrated in groups, which cannot

22 implement averting behavior, similarly to
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1 others. So I think it's important to capture

2 that. That's my main comment in terms of the

3 method.

4 And I will add, because the others

5 have raised other things, my main comments in

6 terms of the presentation of the results. I

7 realize this is the first draft, so first

8 crack at some ideas, but I have some

9 suggestions.

10 First of all, I think you need to

11 clearly justify what sub-groups you're going

12 to focus on. And why you're choosing

13 particular sub-groups. And think carefully

14 about which sub-groups you want to show. 

15 That's one comment.

16 Because you focused on children,

17 children who are exercising outdoors or

18 something like that. It was not clearly

19 justified. And I realize this is just a

20 first draft.

21 The second comment has to do with

22 what metrics of exposure should be shown. I
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1 mean, you opted for showing, at least in the

2 figures, dichotomized exposure, right? 

3 Percent of kids, I think, who are with 8 hour

4 exposures above whatever.

5 That has to be clarified in terms

6 of what that means exactly, because is it

7 like, what does it mean 8 hour exposures? Is

8 it like how many times, is it just once, I

9 couldn't get a sense of that.

10 But more generally, I mean, I

11 think to me, what we really would want to see

12 is the, because it's what's most important to

13 the population health impact, is the

14 distribution of exposure. Not dichotomized,

15 because it's exposures we've seen that is

16 related to risk in a pre-linear sense.

17 What's really going to drive the

18 population risk is the whole distribution

19 curve, not just how many people are above a

20 particular level. So if there's a way in

21 which you could describe those distributions,

22 I think that, and that might be more succinct
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1 then all these figures with percentages in

2 them.

3 And also, the distribution would

4 also allow us to see how much variability

5 there is, which I think would be an important

6 thing to do. Because essentially, with the

7 standards, what you want to do is shift the

8 whole distribution down. And then figure out

9 what impact that has on the risk. So showing

10 the continuous form, I think, if there's any

11 way you can do that, I think that would be

12 very valuable.

13 Another, I mean, this is a

14 relatively, I guess, minor point. But you

15 have this nice section looking at sources

16 where you do some statistical analysis of the

17 simulated exposures and quantify, you know,

18 contribution of different factors. And that

19 section was very nicely done.

20 I guess I don't totally see the

21 point of it, because it is simulated data,

22 right? So you're getting out of it what you
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1 put into it. So it could be a little bit

2 misleading to present that as conclusions

3 about what factors drive exposures. Because

4 really, it's what you were able to put into

5 your model that you're getting out of it.

6 So at least some qualification of

7 that, because really, maybe the factors are

8 actually quite different. And this has to do

9 with the time activity stuff as well. So

10 maybe explaining a little bit more the

11 purpose of that section and some of the

12 caveats around it.

13 And finally, regarding the

14 uncertainty/variability issue. Obviously,

15 you know, as I think the document says, some

16 of the, you know, if we were able to better

17 capture variability, we would reduce

18 uncertainty. And I think an important source

19 of perhaps unaccounted for variability is

20 this whole time activity stuff.

21 And I think if there's any way

22 that one could do some sensitivity analysis
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1 to the impact of time activity on some of the

2 results. And I know that would be difficult,

3 but that would be something that I'd be

4 interested in seeing. Because it is an area

5 where there's a lot of uncertainty. We might

6 not have the right data.

7 And finally, and you know, I'm

8 sure we'll return to the discussion, but the

9 whole issue of background and how it's

10 incorporated, it's almost a philosophical

11 debate.

12 But if you do include background

13 in estimating exposures after meeting certain

14 standards, then I think it would be given,

15 from what I've heard, there's these different

16 backgrounds, there are different ways of

17 estimating the backgrounds. Maybe we need

18 some sensitivity analysis in regard to the

19 impact of using different backgrounds as

20 well.

21 But I'm sure we'll talk more about

22 the background issue at some point, but
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1 that's it.

2 CHAIR SAMET: Okay, thanks. So we

3 really actually don't have time for

4 discussion. I think what tomorrow we'll do

5 is ask for sort of a brief pr‚cis again from

6 the three of you to remind us. Helen,

7 perhaps you could be in the lead on

8 summarizing this.

9 As a reminder, we do get together

10 again tomorrow at 8:30 and, Angela, let me

11 turn things to you.

12 DR. NUGENT: Right, that's the

13 official time we reconvene. Unofficially, we

14 have dinner for the panel members tonight at

15 6:00. I have sent you the location, but

16 again, it's La Volta Restaurant on

17 Fayetteville, so you exit the hotel, look to

18 your right and turn to your left and it's

19 across the street. It's maybe two minutes

20 walk. La Volta at 6:00 p.m. and reservations

21 are under my name.

22 But thank you all and see you
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1 tomorrow morning.

2 MALE PARTICIPANT: When do you

3 need these --

4 DR. VU: You have to bring

5 everything back to your room. Please bring

6 your, all the materials and laptop with you. 

7 Thank you. We have to clear out. Thanks.

8 MALE PARTICIPANT: When do you

9 need the summaries from the panel leader, you

10 know, the discussions?

11 CHAIR SAMET: I'm sorry? Not yet,

12 Dave. No.

13 (Whereupon, the above-entitled

14 matter went off the record at 5:03 p.m.)

15

16

17

18

19

20

21

22
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A

abandon 390:3

abandoned 297:11

388:15 389:21

abandoning 297:16

abbreviation 414:3

abbreviations

357:10 414:2

ABCD 81:16

ability 102:20

320:4 342:18,21

343:1 347:8

402:21

abject 278:13

able 82:11,17 87:18

107:6 144:6 202:7

206:22 237:13

251:11 253:10,11

254:20 255:13

305:3 370:16,17

370:22 395:9

396:6 414:5 420:4

420:16

above-entitled

106:22 223:5

354:1 423:13

abroad 103:21

absence 252:12

358:4

absent 206:22

365:5

absolute 275:17

327:14 341:10

374:1

absolutely 143:22

180:16 219:14

370:7

abundances 258:16

academic 160:13

161:1

accept 164:9 330:3

accepted 77:14

150:12

accessible 262:17

accompanied

309:12

accomplished

105:22 375:12,13

account 50:6 52:17

59:12 64:1,14

104:11 111:9

230:21 246:8

248:2 249:7 252:3

261:22 273:17

275:7 294:15

317:4 319:6

331:20 353:4

370:9 380:12

397:5

accounted 305:22

310:8

accounting 252:5

252:17 337:22

accumulative

215:16

accurate 338:10

accurately 50:17

achieve 253:10

343:9 344:2

achieving 248:22

346:17

acid 218:4

acknowledge 99:15

105:1 145:10

303:8 306:14

404:5

acknowledged

40:16 308:2,21

416:3

acknowledging

416:11

Act 6:11,16,17,22

9:6 12:19 48:16

50:3 58:21 233:15

acting 80:9

action 8:18 99:4

165:8 167:13

168:3,15 169:5,9

active 162:13

349:17

actively 25:8

activist 142:14,15

142:17

activities 279:4

activity 23:20

152:9 163:5

170:18 209:9,12

280:1,12 349:11

403:12,14 404:3,5

404:8 415:17,20

416:15 420:9,20

421:1

actual 56:5 86:6

150:1 164:1

208:14 326:2

acute 41:3 219:10

Adams 52:1 355:22

adaptation 202:16

add 30:7 47:16

86:17 87:2 129:20

147:13 171:21

178:17 209:15

210:2 357:2

372:12 374:10

391:2,12 407:6

417:4

added 18:22 22:4

23:8,14,16,20

24:2 30:5 37:9

65:11 85:14

172:10 173:12

198:10 354:16

adding 25:16 33:1

37:3 58:7,15

158:3 171:21

172:12 209:3

254:15,16

addition 17:5 40:6

95:4 145:12,17

194:6 244:3 275:8

305:19 306:6

307:12 310:19

313:4 370:3

additional 8:2,6

25:16,17,18

105:22 235:5

261:5 281:20

294:5,9,10 329:15

337:16 374:4

391:10

Additionally 56:13

346:6

address 9:19

182:19 233:15

240:5 243:18

247:7,13 273:11

305:10 323:16,18

333:21 400:5

addressed 65:14

122:17 126:8

148:21 192:14,18

217:11 317:1

391:15

addressing 61:1

63:11 93:2 248:19

adds 391:18

adequacy 34:14

247:16

adequate 28:10,16

29:2 58:22 200:14

200:18 203:2

269:7 271:15

292:22 363:20

adequately 149:16

156:21 214:1

254:20 326:13

adjoint 382:16,19

Adjourn 5:22

adjusted 305:17,18

adjustment 273:5,9

274:6,16 275:3

adjustments

252:20 273:3

332:4

Administration

12:3

Administrator

6:18 237:3 240:17

253:18 254:6,20

256:10 257:4

267:12 354:18

355:13 359:3

admissions 27:9

371:2

adopted 94:14

109:10

adults 47:3 282:18

283:16

advance 7:18 8:12

8:12 9:5 265:16

364:19

advanced 105:12

259:17 265:19

advances 55:1

advantage 207:21

282:3 380:7

adverse 38:10,17

41:20 43:7 46:2

51:14 62:12 119:8

309:10 339:20

340:1,12 352:8

adversity 309:20

adverting 162:11

advice 6:18 12:2

114:10 159:16

230:14 235:6

240:19 244:16

260:22 262:19

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Altmans 325:4

Altman's 324:17

altogether 195:2

alveolar 174:21

175:5

ambient 6:19 11:18

39:1 42:9 44:21

50:12,16 51:15

123:3,6,14 131:14

205:16 206:5,13

209:18 213:19

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143:10,20 154:5

American 31:19

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36:18 37:8 38:2,8

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93:20,22 100:7

101:4,8 103:14

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131:22 145:22

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amount 70:4 120:4

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218:17 221:17

224:18 247:20

256:11 261:6

262:14 278:11

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5:20 16:15 178:15

184:18 193:21

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analogy 111:2

analyses 89:13

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290:20 291:11

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169:20 175:11

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249:16,17 268:20

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atmosphere 142:21

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133:11 174:7

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203:16 337:18

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22:14 42:17 48:2

51:7 93:16 240:13

246:20 314:13

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116:16 119:19

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148:16 174:15

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187:8 195:12

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216:2 238:17

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181:16 184:21

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318:12 328:22

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101:11 112:12

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297:19 305:15

311:22 314:15

315:1,6 316:7

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178:6,11 179:22

217:13 225:12

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beneficial 388:10

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113:17 114:22

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125:3 136:8 138:7

162:13 167:15

168:11 176:8

177:1,6 196:16

204:4,10 270:14

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338:3 353:12

362:3 363:1

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402:13 405:5

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beyond 34:2 82:11

96:7 110:16 128:6

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bias 41:10 53:10

60:1 122:19

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392:5

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biases 332:9

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big 14:21 57:6

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379:11,14,18,18

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416:16

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biology 99:15

biomarker 340:10

biomass 69:19,22

bit 19:8 22:1 58:1

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137:19 140:21

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171:3 181:12

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187:2,20 188:11

194:12 196:1,15

209:12 210:10

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271:19 322:12

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Bithell 85:12

black 26:21 31:10

216:19 403:7

block 226:7,9,9

blow 324:6,7

blue 31:16 130:11

270:21 271:5

333:7 344:4

Board 11:11

Bod 182:13

bodies 103:22

body 26:1 42:20

43:5 242:8

boil 174:13

boiler 127:14

bold 135:14

bolded 129:4,7

bolstered 45:6

bore 136:3

Boston 293:2

bothered 146:4

367:12

bottom 27:7 31:4

31:17 32:14,15

33:12,18 60:3

81:7 82:18 172:15

173:14 220:16,17

226:9 288:21

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bound 160:10

269:21 287:22

288:1 306:8 373:3

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boundary 71:12

90:2 92:7 286:18

bounds 76:19

90:10 272:4 305:4

305:6 306:10

box 234:22 272:1

403:7

boxes 227:16 230:7

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Bradford 94:21

95:11

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16:4,4 64:7 78:8

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127:6 152:5

153:12,15,17,20

154:8 155:5

202:15 203:6

357:8 359:13,16

364:18 373:9

Branch 18:14

break 72:8 106:10

106:13,17,19

353:21

breaking 222:9

Breaks 106:11

breath 102:18

breathe 44:20

103:22

breathing 170:18

308:20 350:12

365:14

brevity 218:16

brief 54:16 108:3

127:3 145:2 162:5

164:22 176:2

225:2 230:10

237:9 268:2,13

374:7 422:5

briefly 18:16 91:14

98:19 114:18

212:21 221:9

229:20 235:13

briefs 234:8

bright 245:20

bring 166:8 168:16

191:17 202:8

214:4 215:7

244:18 260:16

356:7 358:9

360:19 377:2,3

423:4,5

bringing 160:12

brings 79:5,11

191:2

broad 35:3 60:17

120:15 133:13

151:8 152:1

241:11,19 399:5

broadest 240:12

broadly 54:21

broken 28:7

brought 19:20 20:3

36:12 56:10 65:12

92:11 153:9 167:2

169:15 191:9

201:22 212:18

236:8 325:3 399:6

404:14

Brown 2:13 3:9

18:6 20:12 22:9

22:11 37:6 393:9

396:4,16,19

Bryan 2:14 4:20

225:5,16 228:16

234:15 256:19

258:22 259:12

269:20 302:6

375:9 376:14

392:10 393:8

399:9

Bryan's 257:21

384:3

Budget 235:16

236:9

Buhler 325:1

build 59:18 348:14

bulkheads 171:13

bullet 252:2,2

292:16

bunch 196:4

burden 311:21

312:22

burning 69:19,22

business 298:10

busy 14:20

buy 87:20 223:3

254:18

buzz 110:16

C

C 47:4 81:6,15,16

cadre 175:10

calculate 303:4

304:7 306:7 330:7

calculated 30:2

272:5,7 308:8

calculates 397:4

calculating 60:19

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367:11

calculation 159:5

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calculations 29:15

318:21 330:4

331:15 401:17

California 15:6

16:7 67:19,20

68:4 69:2 92:1

186:17 277:5,15

299:18 322:8

call 81:6,16 192:10

227:21 266:1

400:4

called 79:7 82:12

94:7 153:4 233:10

361:5 379:17

calling 361:21

362:4 364:2

calls 97:19

cam 218:14

camp 392:6

campaign 146:2

CAMx 30:20 31:14

31:16 32:19 35:14

88:14,18 89:16,18

89:20 90:8,22

91:15 92:1,5 93:6

331:6,8,12 333:2

333:5

Canada 73:21 74:5

153:6

Canadian 76:8

Cancer 43:3

canopy 212:2

capable 90:9

capacity 6:9 280:19

capture 157:3,3

169:14 392:1

417:1 420:17

captures 156:21

279:6 289:13

326:13

capturing 134:3

cardio 365:18

cardiovascular

21:14 24:19 27:8

27:19 38:11 39:7

40:14 46:6,17

102:3 103:5

177:19 178:13

179:18 180:5,21

181:14 182:6,16

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carried 14:3,6

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carries 375:19

carry 14:7 155:13

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carrying 152:22

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CASAC 1:13,16

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8:20,22 10:15

11:15,15,22 12:1

13:2,4,8 14:1,4

17:13 22:22 23:17

24:20 27:22 29:11

30:6 33:4 34:20

42:14 45:6 48:12

55:15,18 76:10

101:20 106:1

109:13,13 114:8

114:10 191:8,14

201:21 226:15

228:1,18 229:12

229:14 230:14

234:19,21 235:4,8

235:11 244:16

261:5 264:5,8,11

264:16 269:6

270:7 289:18

323:15 325:11

340:17 354:17

355:7,14 356:10

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367:10 368:4,9

CASAC's 27:16

47:21 240:19

254:2

cascade 101:17

103:10

case 33:9 55:16

81:16 82:1 96:12

116:17 207:10

219:18 221:1

233:1 245:16

252:9 268:20

269:14 274:8

275:9 284:17

286:7 287:11

312:17 333:7

343:20,21 344:2

347:7 360:22

368:15 389:2

396:12

cases 75:16 187:9

189:12 330:12

cast 215:15

CASTNET 31:8

32:12 120:20,22

casual 130:3

catch 234:17

categories 28:8,9

113:15 199:17

311:11

categorization

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category 113:3,6

116:14,22 117:4

201:14 345:7

causal 21:13 24:19

24:21 25:1,2,4,13

26:10 27:18 38:10

40:18 42:1 46:2,3

46:5,15 62:6 96:8

100:5 105:17

112:20 113:4,6

115:9 116:6,15,18

118:1 127:21

128:10 129:17

177:21,22 178:4

178:10 179:16

180:2 196:22

303:12,15,17

306:5

causality 40:12

43:10 95:12 110:9

111:7 117:21

118:9,16 128:13

199:8,11,15

causation 49:20

129:4

cause 54:2 97:20

194:18 312:13

326:18 328:7

caused 86:10

105:10 352:9

causes 48:7 102:16

116:16 212:2

342:18

causing 172:10

cautioned 51:12

cautiously 211:11

caveats 420:12

CDC 297:21

cells 172:17 173:8

173:11

center 1:12 16:3

17:10 19:18 186:5

centers 298:17

central 18:8 39:13

46:6,18 50:16

58:9,14

cents 390:22

certain 28:3 47:7

71:9 75:7 82:19

95:6 112:5 133:9

133:19 143:18

154:4 176:9

191:15,18 194:18

195:11,13 216:17

218:2,12,14,17

221:17 271:7

298:7 338:15

346:19 388:7

421:13

certainly 16:22

19:4 21:4,9 36:3

54:22 63:18 72:9

79:20 130:20

131:4,4 146:19

147:3 190:17

191:6 193:14,17

196:3,8 203:6

225:11 235:9,12

238:10 261:22

263:12,20 314:5

368:5 369:12

378:19 380:7

388:16 399:21

certified 8:21

cetera 57:13

172:20 359:9

360:3 372:20

374:5

CHAD 349:11

chain 352:7

Chair 1:14,17 8:20

13:22 14:10 16:19

34:17 35:2 36:15

37:11 38:5 43:14

43:19 48:22 54:15

62:1 63:7,20

65:20 66:12,21

71:3 72:15 78:6

83:6,9 86:22 88:2

88:7 93:17 100:10

100:13 106:4,12

107:3,14,17,22

126:20 132:19

135:13 144:21

147:8 149:1 151:7

155:2,14,19 157:6

159:6 160:7

161:21 163:8,13

164:6,9,12,16,19

168:20 170:7

174:10 175:13,16

175:19 178:14

180:9 181:8 189:1

190:8,22 191:20

193:11 197:9

198:16 200:7

201:9 202:13

203:9 205:3,7

206:18 207:6

213:3 219:20

220:2 221:4,10

222:6 224:3

251:19,21 253:13

257:12,18 258:22

259:6 261:3 262:7

264:19 265:3,6

266:3,10,18

267:19 278:2,5

283:22 292:1

293:13,18 295:7

296:2,14,19 297:2

298:1,14,20 300:6

301:19 302:9

306:16,19 307:2

307:14,19 313:14

314:5 319:8

323:11 328:15,18

335:3 336:6

341:18,21 348:9

353:15 354:4

356:17,20 357:3,6

358:14 360:7

363:10 364:10

365:6 366:1 367:2

372:11 373:8

375:8 376:10,14

377:5,8,12,16

378:1 382:6

386:16 390:5

392:10 393:4,8

395:6 396:17

397:15 398:19

399:8 400:14

410:10 415:9

422:2 423:11

Chairman 313:19

323:15

challenge 20:19

61:17 137:10

challenges 121:19

challenging 18:19

19:4

chamber 192:1

213:14 308:11

361:19,20

chamberless

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chance 258:5

368:22

change 103:17
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chapter's 170:21

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characteristics

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characterization

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characterizations

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240:2 243:21

247:2 282:11

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351:17 354:15

characterized

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characterizing

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407:11,12

charge 13:6 34:11

34:13 241:8,9

378:4 387:8 402:1

406:8

charged 49:8

chart 411:8

charter 11:15

chartered 6:14

check 272:20

365:13

Chem 90:22 331:7

chemical 76:14

84:4 138:19

273:11 331:21

chemistry 3:21

29:19 136:17

137:15 142:21

342:11 363:18

380:8,12 382:2

Chief 18:14

children 47:2

186:22 278:10

283:7,12,13 293:6

340:14,16 341:4,6

348:20,22 349:4,6

349:15 403:18,21

404:8 417:16,17

Children's 186:18

187:19

China 152:16

Chock 2:3 3:23 4:2

5:14 16:10,10

149:2 153:18

163:10 297:4,8,15

386:18

choice 246:16,17

373:5,7 398:6

choices 389:13

choose 255:1

372:19

choosing 397:22

417:12

chopped 134:8

chose 271:9 297:22

354:18 372:19

chosen 122:12

Chris 14:7 16:17

107:5,10 126:21

127:7 130:14

132:22 133:15

136:13 137:7

159:7 227:12

296:3 389:11

399:12

Christopher 3:14

3:19 5:4 88:9

328:19

Chris's 132:20

133:11 134:1

chronic 219:11

circle 261:16

358:18

circled 366:3

circles 271:5

274:20

citations 402:3

413:6

cite 315:12

cited 85:13 190:10

325:13 403:6

cities 41:15 43:2

126:4 294:9

311:10 312:7

326:17 328:5

331:20 344:3

387:18,22 393:15

393:16 398:22

414:17

citing 329:19

city 1:12 274:12

290:19 305:13

312:4 316:4

318:16 345:7

352:22 353:3,8

369:21 370:8,15

384:20

civilian 252:5

claiming 254:5

claims 95:4 97:18

claret 180:16

clarification

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171:15 190:18

210:19 252:2

288:7 292:14

297:5 299:2 300:8

405:3 410:21

413:15 414:12,14

clarifications 35:4

157:19 292:11

clarified 22:4

117:11 124:7

136:7 172:14

355:9 409:5 418:5

clarifies 46:11

clarify 22:7 133:11

190:9 238:4

clarifying 8:2,6

9:19 12:14 265:13

329:20

clarity 116:2

160:14

class 147:11

classification 97:17

189:21 199:9,20

200:12,16 201:5

201:10 303:17

classifications

199:11 233:1

classified 303:15

classify 195:10

clean 1:3 6:5,17

11:14 44:9,17,20

45:17 46:13 47:9

48:16,17 50:2

58:21 59:17 62:17

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281:11 339:8

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98:6,12 116:21

123:10 125:10

127:7 131:2

132:11 140:17

155:6 161:12

170:14 176:7

189:16 195:20

196:1 201:12

206:14 210:11

238:5,14 245:17

261:19 329:12

335:11 361:10

362:12 384:9

397:19 400:11

403:14 406:2,12

409:17 411:10

412:6 415:21

423:7

clearer 163:3

227:15 374:18

clearly 64:15 99:16

109:12 118:19,22

132:14 135:2

160:4 161:4

179:19 183:5

205:9 244:21

260:18 292:7

355:1 368:14

395:20 410:17

417:11,18

click 130:10

climate 117:12

118:3 149:4

clinical 25:11 51:18

132:6 181:18

182:9 242:7 267:8

281:8 301:11

308:16 310:20

327:21 340:3

clinically 51:21

clipping 287:6

close 61:8 86:11

134:6 217:2

closely 106:9

149:21

closer 250:1

closes 217:5

closing 54:9

cloud 90:6

Club 43:21 44:7,8

45:17 46:13 47:9

48:17

Club's 44:11

CMAQ 89:15,18

90:3 270:7 273:9

275:13 326:9

331:10 379:17

382:15 385:8,20

397:10

CMAx 334:15

Cm-3 150:2

coast 67:20 69:10

69:14 71:18 83:5

92:6 320:21

321:18

coefficient 368:18

coefficients 315:17

315:20 317:21

331:19

coffin 369:2

coherence 40:20

43:11 98:1 111:2

cohort 43:1 51:4

coincidence 79:19

80:15

coincident 73:19

78:2

cold 27:1,1 311:13

colleagues 12:9

168:8 200:9 360:1

color 18:21 27:12

colors 328:3

columns 115:11

combination

203:20 389:15

combinations

312:18 394:7,10

combined 199:10

281:15 311:2,11

312:1,8,12

come 68:12 83:4

112:4 121:17

134:12 155:3

162:17 177:3

183:8 188:17,19

193:8 208:5

210:21 233:18

235:20 257:13

259:9 261:7 268:1

298:20 356:2

357:21 362:13

387:19 392:4

396:16,17 398:4

400:20 406:2

412:21

comes 124:12

188:8 193:6

228:12 230:19

231:3,12 242:12

279:13 320:12

346:12 359:20

363:4

coming 67:21 69:8

79:12 80:8 81:3

84:22 85:17

139:14,17,18

140:14 142:15

228:17 245:3

260:4 332:14

commend 115:3

commendable

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comment 3:10 7:15

7:16 9:13 35:13

37:14 44:1 54:14

54:16,21 55:9

62:4 63:13,21

64:3 66:14 88:1

100:12 108:5

109:17 114:5

116:2 122:18

125:20 126:1

132:20 135:7

146:10 147:9

148:7 156:7

157:15 162:12

163:11 168:9

169:3,12 170:4,5

171:2 178:12

180:7 189:4

190:22 191:4

194:13 197:10

202:14 203:10

207:12 215:10

216:4 222:15

229:13 235:1,9,13

241:1,16 255:6,21

264:4,8,12,15

292:10 296:3

300:13 302:2

313:20 314:2

317:11 335:14,16

352:17 353:17

357:18 358:17

365:8,10 375:14

390:12 392:11,13

395:7 397:15

400:7 417:2,15,21

commented 136:13

146:5 152:2

commenter 66:18

88:9 101:3 113:1

265:10

commenters 11:1

106:6 123:1

222:17 266:17

302:3,10 353:18

395:8

commenting 401:1

comments 5:1 7:19

8:2,7,11 10:4 13:2

13:5 17:14,16,17

17:20 19:15 21:18

22:22 24:7 29:11

29:12 34:9,19,21

34:22 37:20 38:9

42:15 43:16 48:18

48:21 49:1 54:16

55:6,10,21 62:2

63:9,11,22 65:21

71:4 78:7 88:12

88:15 100:9,11

101:1,15 106:1,5

106:16 107:5

108:3,4,16 109:3

119:18,20 126:21

127:3,8 130:6

131:1 132:18

134:1 136:3,4

145:2,7,17 149:3

151:5 157:16,18

159:6,11 162:7

164:1,4,16 166:15

166:16 168:22

170:10 171:18

174:14 175:17,19

178:1,18 190:5,6

191:6 193:12,19

194:2 198:4 201:5

201:19 202:3,6,11

205:11 206:7,19

207:4,8 217:12,17

219:22 220:3

221:4,5,13 227:13

230:2 234:22

235:5 236:17

237:2 255:7

256:21 261:22

263:2 264:17,18

265:1 266:22

277:9 302:18

306:17 307:6

313:15 319:9

328:16,21 335:4,6

336:13 342:3

348:10,14 353:16

354:9 358:22

359:7 360:8 364:9

364:11 365:7

366:1 367:13

371:17 375:22

376:11 377:9

383:18 386:15

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comprehensibility

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comprehensively

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computations

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computer 54:4

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concentrated

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concentration

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121:3 123:15

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243:7,16 244:19

244:22 249:14

269:11,12 270:3

271:8 272:11

273:17,18 275:18

275:19 277:2,5,10

277:18 280:13

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concept 131:20

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conceptual 5:9

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conceptually

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concern 87:7 126:8

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conducted 48:4

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conducting 25:9

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240:3 242:19

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289:2,7 305:4,5

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conflation 194:17

conflict 9:7

confounded 53:1

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consolidated

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contributing 154:4

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Convene 3:3

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convening 13:13

conversation

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convey 108:11

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conveyed 353:12

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convinced 84:19

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cool 291:4

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copies 78:4 117:15

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Corporation 88:10

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correctly 90:17

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courtesy 85:13

cover 88:21,21 89:3

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coverage 315:3

covered 285:14,19

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co-variation

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create 346:16

created 275:21

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credence 86:17

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credible 100:5

creep 36:5

crisp 374:17

criteria 50:2,11

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195:9 271:7

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critic 148:11

critical 12:17 52:6

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criticism 127:3

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criticisms 216:2,2

crop 211:5 214:1

crops 208:13

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crossing 140:1

crowded 14:12

crucial 95:1

curious 199:7

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currency 149:14

current 38:12,18

38:21 41:2 43:8

45:14 49:15 52:11

67:8 68:6 70:15

105:7 129:14

135:4 220:20

242:21 247:9,17

248:5,8 249:1,10

250:22 253:6

255:2,11 269:10

269:11,13,18

270:12 271:10

274:5 283:11

284:18,20 285:7

286:22 287:4,10

287:11 290:13

304:22 327:20

330:5 371:11

394:5 404:14

412:20

currently 44:15

47:13 61:20 73:1

76:14 90:8 93:3

148:18 249:9

curve 99:13 395:18

418:19

curves 281:6,16,20

314:13 315:18

371:15

cutoff 105:13

341:12

CWS 75:11,19 76:7

cycle 230:13

cyclone 149:15

150:19

cyclones 149:9

cystic 198:7

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

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D

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daily 31:6 33:7

52:2 77:20 121:22

145:14 275:22

276:13,20,22

277:11 279:4

308:9 328:7

damage 99:8

172:10,17 173:8

Dan 35:10 152:6

Dana 65:21

Daniel 2:5 3:22

5:13 16:8 83:13

135:15 151:9

155:17 157:8

158:3 250:19

251:5 257:19

298:21 325:3,6

382:6

Daniel's 159:11

320:3

dares 292:4

data 27:6 28:16

29:20 30:11 31:5

33:8 40:4 41:12

42:7 55:4 57:20

58:2 60:3 62:13

68:17 82:18 89:17

90:21 91:3,9 93:4

96:1,5 99:10,12

99:21 104:20

121:21 134:19

160:9,15,17

166:13 181:19

182:2 183:22

186:18 192:1,11

214:10 216:22

232:3 233:7

239:12,20 269:2,3

271:12,12,13

275:13 277:16

281:7,20 282:20

283:6 299:17

308:11 317:13,17

318:3,5,7,11,14

318:15,16,20

319:2 320:17

321:2 329:1,5,6,8

329:22 330:3,6,10

330:12,15,22

333:2 337:6,16,18

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375:3 378:6,13

385:3 386:1 403:5

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database 297:9

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databases 403:11

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date 90:9 209:17

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Dave 213:3 262:8

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David 2:3,4 3:23

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163:15 386:17

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David's 392:6

Davis 167:18

day 7:17 14:2 80:22

86:5 143:15 144:7

183:6 228:7

236:10 321:2

325:12 346:12

350:12

days 12:13,22

13:10 33:14 34:1

58:12 64:2 78:1

80:20 86:6 104:17

133:8 149:10,17

150:9 259:3

260:22 370:11

daytime 320:16

321:5,13,15

DDM 148:19

dead 253:21

deadlines 236:14

deal 86:21 127:13

154:22 158:14

243:10 244:20

dealing 251:7

325:15 378:5

deals 85:12 324:15

dealt 66:8,10 116:4

death 103:3

deaths 254:16

debate 62:6 66:14

344:12 421:11

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defending 44:19

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deja 302:15

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deleted 19:1

deleting 37:3

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depending 121:12

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derived 318:7

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describe 76:22

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designated 2:12 6:5

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designations 28:22

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despite 98:22

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detrimental 195:16

Detroit 344:3,9

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developing 73:3

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development 12:7

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devices 404:7

Devlin 182:13

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diabetes 47:12

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diabolic 298:17

diagnostic 338:22

diagonal 81:1,4

diagram 101:17

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diagrams 101:21

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dialog 390:14

diaries 407:14

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dichotomized

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53:14,18 92:20

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126:4 128:12,13

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differential 196:4

differentiate 195:5

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differentiates

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differently 50:4

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differs 32:1 384:16

difficult 41:8 52:14

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difficulties 73:11

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difficulty 76:12,16

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diffuse 90:5

diffusion 171:9,10

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digesting 115:7

digression 144:13

diligent 400:5

dimension 110:7

dinner 422:14

dioxide 40:2

direct 79:18 170:15

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directed 54:5

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direction 137:20

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directions 177:12

directly 10:8 216:8

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director 2:12 11:11

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186:2 215:6,9

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discuss 13:5 82:10

98:20 134:12

217:6 219:17

268:15 309:19

391:16 415:13

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85:19 98:13

119:10 122:21

166:3 170:20

212:20 246:1,3,4

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332:22 381:17

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13:9 21:12 22:2,4

23:14 24:10,14

25:6 60:18 66:17

67:9 96:16 98:4

98:15 103:13

107:4,9 109:18,21

114:8 115:13

118:21 120:18

121:2 122:6,9

124:2,9,22 125:18

125:21 126:5,18

128:3 131:9 132:8

135:22 136:10

144:18 151:11,12

151:14 152:1

155:3,15 156:20

157:8 163:16

170:11,13 172:7

172:11,12 194:17

204:19 209:21

211:13 214:6,9

217:9 219:16

225:18 237:14

238:2 250:9

261:15 266:20

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292:8 313:19,22

314:20 317:2

329:20 360:19

379:15 390:10

403:22 404:2,11

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405:12 415:22

421:8 422:4

discussions 8:18

20:4 25:12,15

63:16 97:12 133:7

152:4 354:15

370:22 423:10

disease 41:19

181:14

diseases 27:11

dismiss 215:2

dismissal 54:18

dismissing 215:1

dismissive 119:18

dissecting 371:13

distally 169:17

distance 174:19

distinct 49:19

distinction 179:10

196:17 197:5

200:2 207:16

209:6 362:4

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distorted 388:8

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388:6

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distribute 202:10

distribution 272:2

273:22 282:10

316:12 317:8

330:17 332:10

333:11 371:20

384:18 392:2

418:14,18 419:3,8

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244:12

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385:17 416:8

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diurnal 156:22

272:6 273:16

319:13 320:9,20

322:6,19,21 323:9

325:16,19 381:8

diverse 345:1

diverting 407:14

Division 17:10

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docket 236:20

doctors 59:18

62:17

document 10:12

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18:18 19:5,12

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dosimetry 4:4

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168:9,11 169:4,8

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doubling 63:5

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64:5,17 66:20

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downturn 126:10

downward 90:2,4

149:8,14

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3:12,13,14,15,15

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4:2,2,4,5,5,7,8,8,9

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13:15,18,21 14:9

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15:15,17,19,21

16:2,4,8,10,13,15

16:17 17:7 22:9

22:11 34:18 35:11

36:6,17 37:6 38:3

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55:13,18 56:9

62:3,14 63:8 64:5

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66:20 71:5 72:1

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77:2,4 78:8 79:1,2

79:20 80:3,4,6,7

80:11 83:7,14

85:5 87:6,7,21

88:5 92:17 93:21

107:12,16,20

108:1 127:6

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152:19 153:12,14

153:15,16,17,18

153:20 154:1,1,8

154:12 155:5,11

155:16,20 156:13

157:4,17 158:8,10

158:17,21,22

159:2,8 160:8,21

163:10,14 164:8

164:15,21 168:21

170:8 174:12

175:15,18 176:1

178:16 180:10

181:9 190:8,11,12

190:14,15,17

191:5,12,14,21

192:8,9,12 193:2

193:22 197:10

198:17 200:8

201:20 202:15

203:4,6 204:11

205:5,12 206:2

207:3,7 213:4

220:1,4 221:3,7

221:11 234:16

235:13 237:7,8,17

251:20 252:1,4,7

252:8 253:1,3,14

255:4,10 256:7

257:5,8,15,20

259:4 264:3 265:9

265:12 266:8,13

267:3,10,14

283:19 284:1

292:13 293:3,17

294:2,17,20,22

295:5,10,22

296:11,22 297:4,8

297:15 298:3,6,15

299:1,14 300:2,7

300:20 301:3,10

301:16 302:6,14

306:18 312:15

313:1,18 314:6,21

316:10 318:18,19

322:14 323:14

327:9,11 328:17

334:2 335:5,20

336:10 341:20

342:1 346:14,15

348:2,4,5 352:3

353:5 354:8

356:18 357:1,4,8

359:13,16 360:9

363:11 364:18

366:18 367:7

372:12 373:9

376:1,12,15 377:6

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386:18 390:21

392:12 393:5,9

395:7 396:4,16,19

398:16,20 399:13

400:22 407:9,22

408:6,9,14,21

409:4 410:5,11

414:13 415:3,6,8

415:14 422:12

423:4

draft 11:17 12:11

14:13 17:18 18:1

20:3 22:22 25:19

32:3 33:1 43:6

44:2 45:10,12

46:4,11,21 48:5

55:21 56:2,3,11

88:13 94:2 97:16

99:18 101:10,15

101:22 105:11

108:2,14 114:22

115:1 119:14

135:18 145:4,8,9

147:7 165:2 170:9

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217:19 226:11

244:11 247:15

248:20 249:4,10

250:9,10,12 253:4

255:5 256:18,22

264:14 265:15

268:3,22 269:10

269:15,17 270:2

270:10,19 271:1,3

271:21 273:2,8

276:5,9 278:16

281:22 283:1

284:18 300:5

301:9 302:20

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309:19 336:16

337:5,7 350:5,16

350:19 381:15

383:17 399:19,21

400:10 409:6

414:16 417:7,20

drafts 68:7 99:2

237:21 260:4

dramatically 50:21

89:3 147:6 312:11

313:7

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229:4 238:12

drawing 200:1

drawn 179:7

draws 159:18 229:1
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drought 386:20

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drummed 183:21

dually 400:5

due 81:13 90:5

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211:22 317:22

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duplication 376:4

duration 99:6

dynamics 86:14

150:2

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159:9 160:5 164:2

196:20 215:10

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342:2

economical 388:22

ecosystem 54:8

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103:10 113:11

116:22 118:10,11

118:14,22 119:2,6

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124:6 176:10

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179:11 182:4

184:8,18 186:4

187:5,14,15,17,18

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195:7,12,22

196:12,22 197:3

203:20 204:13,19

205:13,16,19

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239:18 252:21

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310:12 316:12

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210:13

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192:4 279:18

315:22 371:4

388:21

effectively 195:6

effects 4:6,13 21:14

23:6 24:19,22

27:8,20 28:4 29:3

29:4,7 38:11,15

38:16,20 39:7,16

39:19 40:9,14

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46:3,7,11,17,19

51:19,21 52:20

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98:1 99:21 100:6

101:18 102:3,22

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116:4,11 118:3,5

123:13 130:3,22

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177:13 179:17

180:5 181:14

182:16 183:20

185:7,12 186:9,15

187:12 188:10,13

188:15 200:13

207:19 209:19

213:7,8 214:13

220:13 221:18

302:20 304:6

305:21 307:11

309:11 310:2

313:5,8 317:21

340:1,12,19 352:8

352:10 355:19

360:13 363:19

367:19 371:3

efficiency 84:2

efficient 90:2

138:16 145:5

effort 101:9 178:20

210:21 226:3

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eight 31:6 33:7

45:15 50:15 51:1

70:16 74:6,8

75:19 76:17 86:5

231:19 275:22

276:12,20,21

277:11 278:13

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elaboration 194:9

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elevation 73:14,16

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elevations 71:13

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323:22

ELF 169:16 175:11

eliminates 368:12

396:22

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elucidate 160:3

eluded 370:19

email 10:9 55:16

72:5,10

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Emery 3:14 5:4

30:7 56:14 88:9

88:11 92:17,19

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389:11

emission 149:13

150:5,5 258:13

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58:19 60:12,14

91:21 137:2 143:9

143:11 153:2,6,8

246:14 248:1,4,6

248:7 252:13,21

252:22 253:5,9

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273:14,19 274:11

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emphases 119:22

emphasis 91:6,9

212:5 242:17

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98:16 131:9

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157:13 166:17

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332:12

emphasizes 156:8

empiric 189:6,8

empirical 83:3

employed 91:10

326:9 329:11

empowered 6:16

encapsulated 85:17

86:20

encompass 204:12

encourage 39:7

109:7 325:10

encouraged 332:20
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enhancement

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73:1

environmental 1:1

2:10 4:13 15:22

17:11 19:18 44:18

49:4,7 230:18

environments

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enzyme 209:11

EPA 6:18 11:11,14

12:6,12,20 13:6

16:20 18:12 19:22

25:7 39:7 40:1,16

41:4,22 43:4,9

45:9,11,18,20

47:20 48:13 58:16

58:22 61:13 89:11

89:15 91:14 93:15

94:7,17 95:4,10

96:2,6,17,21

97:16,22 98:22

99:14 100:2 102:2

103:12 105:18

108:12 109:7

114:9 115:3 126:7

145:3 150:13

151:3 152:20

157:21 159:16

176:4 178:8,11,17

181:16 182:11

192:3 194:2

207:10,21 211:21

225:21 232:13

233:17 235:21

246:10 265:8

282:17 303:2,7,13

304:5,6,15,20

305:3,8,9,13,16

305:19 306:2,5,6

306:9,12 308:2,3

308:13 309:17

331:5 332:20,22

334:14 335:1

336:17 337:5,10

338:13 339:13

340:13 341:7,13

343:19 348:19

349:10,21 350:18

351:16 358:13

389:21 390:3

412:17,22

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56:4 59:1 94:3

100:4 106:3 158:5

310:2 313:7

333:22 350:3

410:18

epi 23:16 24:16

125:1,7,14,16

244:7 284:8

311:19 313:8

360:22 361:5

362:9 371:10

407:17,19,21

epidemiologic

110:9 124:22

186:14

epidemiological

23:8 26:12 55:2

121:21 242:1,3,9

267:9 314:8

317:17 326:19

327:21 351:1

epidemiologists

25:10

epidemiology

38:22 41:5 49:14

49:16 54:19 95:19

96:1,13 284:3

287:15,20 302:22

340:21 355:20

370:21

episodes 75:20 87:9

episodic 70:7 71:1

86:4

epithelial 168:5

equal 73:18 74:16

79:16 80:22 81:11

208:14 324:10

344:22

equals 80:18

equate 62:22

196:20,20

Equating 293:10

equation 208:1,1,5

ERF 337:6

ERFs 336:18

error 90:18 299:13

386:12

errors 383:13

escapes 361:22

especially 33:19

54:10 64:15 92:22

129:3 132:2,15

277:2,5 280:13

349:1 380:16

387:16 388:4

404:6,8 409:13

essential 123:12

essentially 79:5

81:13 124:15

326:1,14 328:4,12

363:18 392:15

407:21 419:6

establish 59:2

Establishing 53:21

53:22

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estimate 118:10

125:11 173:2

255:17 256:4

281:16 303:10

304:5 307:7

309:10 334:18

338:10 345:20

379:22 415:19

estimated 31:18

89:19 121:9 246:9

252:11 309:16

327:6 331:8

estimates 23:10,11

41:7,15 93:10

123:21 125:22

135:21 145:13

173:5,6,20 186:4

240:2 243:6,22

248:11 252:20

303:7,9 305:11,14

305:18 306:1,9,13

306:15 309:7,11

309:22 310:10,16

310:17 312:1

314:15 316:11,13

326:14 327:22

331:13,16 342:13

344:17 349:7

373:15,22 374:2,3

386:14

estimating 58:6

76:12 145:20

246:8 247:10

253:15 256:10

280:14 302:20

312:21 421:13,17

estimation 172:22

et 30:7 39:17 42:18

52:1,3 56:14,15

57:12 77:7 99:11

172:20 273:21

276:2 309:18

312:1,5,9 324:13

337:2,8,8,9,12,14

338:2,9 340:4

341:10 359:9

360:3 361:13

372:19 374:4

393:14

ETH 79:3

Ethics 9:6

ethnicity 298:11,12

ETS 309:13

Europeans 154:21

evaluate 60:18

99:20,21 131:1

282:10 310:20

334:14,17 395:9

410:14

evaluated 76:15

96:11 98:9 246:5

285:13 308:22

309:5 350:8,9

355:4

evaluates 96:3

evaluating 52:13

96:1 98:6 103:6
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57:10 61:3,9,15

69:17,22 70:8

71:2 75:13 77:8

233:8,11,11 234:2

365:19 384:2,4,7

384:10 387:1

eventually 367:22

everybody 14:1

131:5 181:15

224:11 393:6

everyone's 44:19

359:17

evidence 23:2,9

24:11 25:4,22

26:8,12 28:10,13

28:17 29:3,7,7

40:17,22 41:17,18

41:20 42:6,11,14

42:21 43:6 45:5

45:13 46:1,15

47:1,1,6,10,14

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99:4 110:8 111:11

111:19 112:20

113:9,16,17

115:19 118:16

147:19 176:7

180:4 184:5

185:12 186:14

189:13 190:2

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200:18 203:2

211:10 239:6

240:14 242:2,3,8

242:9 245:6 250:5

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304:2 305:20

340:18 341:14

evident 96:6

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297:22 357:11

evolving 193:15

EVR 308:9,15,15

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exacerbate 330:21

exacerbations

103:1

exactly 22:19

142:18 407:3

409:10 410:12

418:6

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406:15

examining 51:18

example 23:4 39:17

40:10 51:22 66:5

76:22 78:13 80:13

80:16 81:8 94:16

95:14 96:17 111:1

118:9 127:16

131:14 143:16

171:7 173:22

182:4 195:21

208:13 216:19

239:20 254:12

274:9 277:15

282:7 283:7,8

293:2 294:1 311:3

311:9 317:20

339:6,21 355:3

385:9 398:17

examples 26:17

244:14 333:5

348:6,7 380:5,15

411:5,7 413:3,19

exceedances 87:15

exceeded 45:3

excellent 65:9

163:11 360:11

exception 64:8

exceptional 61:3,15

233:8,10,11 234:2

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fair 140:12 181:22

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135:19 138:8

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377:17 392:18

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occupation 416:8

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opinion 111:13

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opportunities 7:21

opportunity 7:14

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335:16 336:11

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opposite 177:11

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option 235:4

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oral 7:18 234:8

order 105:5 187:17

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270:8 313:18

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ordered 236:14

orders 173:22

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organization 44:9

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organizational

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organizations

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orients 187:21

origin 140:20

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originates 86:9

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outcome 96:18

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outcomes 194:20

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outdoor 29:1 47:3

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outdoors 162:13,19

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outliers 274:20

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outputs 372:4

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215:5 218:9

224:16,21 231:1

231:21 232:18

235:18 243:20

246:13 260:14

266:12,19 269:7,9

278:11 279:15

280:2,3,11 282:9

282:15 283:19

285:2 289:14

292:10 294:6

317:22 318:10

335:9 338:5 339:3

343:3 347:7 348:2

349:16 353:20

354:19 355:8,15

356:11 368:1,13

381:19 391:2

392:8,14 414:7

415:17,20 416:15

420:9,20 421:1

422:3,13

timeline 228:3

timely 19:13

times 26:20 39:15

39:22 66:16 74:1

74:18 75:7 82:19

86:3 124:11

125:17 174:18

192:6,7 233:17

404:20 418:8

timetable 291:14

Time's 353:5

tissue 172:10

174:21

title 136:19 169:7

237:20 373:11

titled 169:4

today 10:2 13:16

14:15 19:11,15

32:9 34:15 38:7

44:7 55:20,20

72:12 88:16 214:7

225:8 231:11

292:11 302:16

324:9 328:21

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today's 12:9,21

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told 201:17

Tole 310:7

tomorrow 8:4

19:15 107:7

225:10 268:11

297:7 400:21

415:12 422:4,10

423:1

tomorrow's 12:10

tone 218:13,15

tonight 422:14

tool 61:9,10 159:13

top 31:3 78:15

81:10 104:7

213:14 226:7

292:16 299:7

301:21

topic 66:16 194:10

219:16 415:11

tops 213:20

total 46:4,19 104:9

116:14 124:6

162:20 182:4

247:10 256:5

258:4,20 280:3

304:7 349:6

351:19 373:22

totally 65:16

129:18 144:2

254:18 382:11

388:12 406:11

419:20

touch 49:11 286:3

touched 181:12

touches 126:1

touching 292:8

tough 164:14

tox 182:1 313:13

362:10

toxic 173:9,11

toxicity 340:22

toxicological

200:21

toxicologically 26:1

toxicologist 49:6

toxicologists 25:12

toxicology 42:5

110:9 313:12

314:18

traces 312:20

track 75:12 225:13

370:20

tract 103:1 166:12

168:5

trajectories 75:1

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321:21

trajectory 79:10

93:14

transfer 86:5

translating 244:6

translation 26:3

transparency

112:15

transparent 53:6

94:8 111:19

transport 69:19

71:17 76:14 81:21

89:16 90:4 139:9
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treatment 65:10

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treats 50:3

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trend 75:13 149:8

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trepidation 257:16

trial 183:10

Triangle 17:9

tried 22:16 115:4

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69:6,11,18 70:18

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troposphere 68:22

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238:4 243:10

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turn 11:4 13:20

22:9 103:4 107:11

225:5 234:15

268:14 277:21

283:17 400:11

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turned 59:16

Turner 149:22

turning 154:3

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twenty 60:9

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two 7:20 10:3 12:22

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92:22 94:2 99:2

106:10 111:2

119:2 121:1 133:7

136:6 149:2 151:8

171:10 179:4

185:10 186:10,19

188:21 191:5

195:5 199:10

204:22 209:10

232:5 244:13

259:2 262:10

263:19 269:3

275:21 276:18

281:2 283:9 284:9

294:2 295:15,19

299:1 300:10

304:6 311:4,7,11

316:17 321:3

325:4,12 329:6

330:1 336:21

343:20 344:2

348:6 373:20,22

374:1 378:7 379:5

383:21 385:21

387:18 389:1,1,2

390:22 393:15

394:20 397:21

403:8,17 407:12

413:4 422:19

type 79:18 80:13

187:6 241:2

284:13 391:3

412:3

types 110:13 171:7

171:16 187:21

198:20 239:16

240:15 346:13

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typical 280:3

typically 89:6

362:18

typo 208:6 300:2

355:6 385:4

T-A-B-L-E 3:1

t0o 198:4

U

UARG 342:3

UC 167:18

ugly 381:9

ultimately 205:2

230:5 318:9

Ultman 2:8 4:5,12

15:19,19 170:8

198:17

ultraviolet 221:15

221:16,18

unable 13:16

unaccounted

420:19

unbalanced 113:2

uncertain 40:15

42:6 250:7 303:19

uncertainties 39:10

40:10 57:9 91:9

98:8 229:1 240:3

248:14 310:17

317:5 404:15

406:9 411:17,22

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57:14 90:19

118:21 119:1

121:8 158:13,15

173:15 174:2,4

279:8 280:6,7,11

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310:8,9 316:21

327:19 334:12

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420:14

unclear 103:16

underestimate

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326:10 351:14

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underestimates

70:8 73:9 349:8

underestimation

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underlying 123:16

230:12

underpinning

327:18

understand 21:9

64:22 65:2 78:8

87:1 90:11 97:19

132:2 133:9 139:5

140:5,8 144:11

152:10 158:5

181:4 184:10

185:15 186:1

190:3 191:22

200:15 222:22

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254:19,21 255:14

256:4,11 258:1,3

259:16 261:20

262:5 310:15

311:20 329:6

330:5 350:2

374:19 375:5

382:19 389:6

390:2 395:12

400:19 409:7

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undertake 94:8

undertaken 88:22

undertaking 93:4

undertakings

263:17

underway 243:2

unemployment

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unexplained 41:10

41:16 305:10

unfortunately

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232:13 237:11

unique 245:13

United 68:2 69:14

71:22 77:19 136:1

152:14 320:22

321:18
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University 15:6,8

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unnatural 380:2

unnecessary

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unprecedented

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unrealistic 260:1

unreasonably

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unreliability 39:13

unreliable 40:3,8

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unsporting 182:10

unusual 210:18

379:8

update 234:13

337:5,6

updated 337:14

updating 281:19

282:20

upgraded 41:22

upper 33:9 84:9

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139:19 166:12

168:4 208:14

227:20 276:19

321:7 373:3

upright 365:15

urban 249:16

268:20 270:20

272:8 273:12

274:10 275:8

277:2 278:19

284:11,16 285:11

285:13 286:1

292:15 298:17

329:1 341:6 381:4

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urge 105:18 117:10

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310:3

urges 105:8

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236:4

use 9:13 11:2 20:21

32:3 39:12 40:3

49:13 61:12 64:13

73:4 94:17 95:5

99:19 147:11

176:15 184:22

185:9 190:16

197:21 242:9

270:7,11 271:2

285:16 288:3

297:10,22 301:14

305:17,19 316:7

317:3 320:6

331:18 341:10

342:9 344:16

361:7 367:18

369:13,19 372:9

373:2 378:13

383:11 388:16

389:18 391:19

394:6 396:12

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21:17 22:18 94:16

127:9 128:16

129:2 130:8

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296:3 381:1 382:4

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uses 96:4 97:22

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369:5

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usually 17:5 272:12

272:15 273:4

320:15

utility 295:1 341:22

382:22 394:19

utilize 49:21

UV 147:1

U.S 1:1 2:10 32:5

36:19 37:7 56:6

56:11 71:8 73:17

77:17 83:3 89:7

91:17 93:10 122:7

143:9 146:20

153:1,1 154:5,13

245:3 247:22

248:2,3,6 252:5

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253:3,5,9,21

270:3 272:2,6,21

285:6 286:18

311:10 312:19

331:10 370:6

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vacillated 119:16

vague 411:6 412:11

vagueness 401:9,10

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valid 111:17 330:7

validated 394:10

validity 213:14

Valley 87:9,15

valuable 224:22

419:12

value 273:1 288:3

323:9 330:7

335:12 338:15

369:20 370:12

374:22 375:5

388:3,5

values 30:1,1 31:8

31:12,14,19 33:3

68:18 69:20 70:11

76:17 147:16

173:2,4 252:15

272:2,9,16 274:1

274:22 287:19,22

288:6 321:5,12

322:10,11,13,20

323:2,4,8 327:12

327:15 370:18

387:17,22 388:2

397:8

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3:9 12:7 17:7,8

34:18 36:6 153:14

154:1 155:11

191:5,14 201:20

203:4

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224:12

Vanessa 2:12 3:5

9:22 11:5,10 14:1

Vanessa's 266:11

vapor 138:20

variability 66:7

125:6,13 174:17

279:7 280:12

288:16 289:10,12

303:9 305:14

306:14 331:21

338:21 339:15

346:8,11 375:15

375:20 406:9

416:10,15 419:4

420:17,19

variants 42:3

variation 52:2

156:22 176:10

189:7 201:16

320:9,20 322:6,20

322:22 323:10

325:22 326:2

339:9

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311:1 319:14

varies 312:11

varieties 211:15

variety 312:2

various 158:11

255:17 273:11

309:8 310:15

319:18 329:2

333:20 360:12

362:20

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272:10 408:19

vast 56:2 127:17

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15:11,11 181:9

190:11,14 191:12

234:16 251:20

252:1,7 253:1

257:15 393:5

vegetation 213:7

214:19 220:12

326:6,8

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velocity 171:9

ventilation 280:15

282:15 308:1

verbally 159:16

verbiage 368:7

verify 129:14

version 17:2 34:22

36:10 145:3 164:2

284:21 291:9

326:10 327:20

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56:2 80:8 170:16

171:9 172:9 177:2

194:19 196:12

200:2 249:16,17

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viable 254:6 332:21

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368:4 388:8

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views 27:17 37:1

94:22 151:12

190:5,6

violation 104:17

violations 104:15

virtually 181:1

287:2

visually 120:3

vitamins 47:4
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VOC 270:15 333:8

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volunteering

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207:9 209:3

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222:20 224:22

226:4 227:12

229:2 231:11

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318:10 320:13

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356:18 358:17

375:12 377:13

379:2 384:5

389:14 390:6,12

392:7,11,13

393:12 394:13

411:20 414:6

417:14 418:11

419:7

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207:15 234:4,13

238:3,14 244:18

261:20 268:4

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292:21 293:7

377:3 415:16

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284:2 302:4

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134:21 198:8

264:22 384:9

405:10 406:1,6

407:7

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138:19 216:6

217:8

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82:8 113:18

118:12,20 139:4

141:14 143:13

160:9 162:14

170:22 173:3

177:3 184:22

188:2 193:5,5

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217:22 243:10

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263:4,21 264:12

265:5,7 301:4,7

301:13 304:5

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318:13 368:10

369:8 382:4,15

383:1,4,7,19

395:20 396:22

398:2,3 400:12

413:14 414:1

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221:14 243:19

281:2 307:13

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373:22 401:19

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340:20

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weakly 222:4

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226:10

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235:3,15 237:15

255:9 256:15

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261:21 262:18

263:12 264:10,21

265:4,19 266:6,11

266:15 267:1,16

278:7 295:18

296:17 297:6

301:6 359:18

360:6

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43:13

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weight 25:3 45:13

46:15 47:10 52:11

53:6 97:5 98:14

112:20 118:15

185:14,21 355:16

359:9

weighted 97:7

215:17

weighting 386:12

weights 282:15

weight-of-evidence

94:3,10 95:1

97:18 98:15 99:20

Weinstein 210:4

welcome 3:5 11:12

14:1 27:16 235:9

welfare 14:17

48:15 58:6 59:6

60:20 130:21

134:18 135:1

154:17 213:8

240:11 309:2

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329:15

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105:6

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went 34:3 107:1

133:16 165:2

223:6 354:2

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350:8 410:16

Wernli 79:2

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225:16 267:21

292:20 293:5

297:12,18 299:11

299:15 300:4

west 35:21 36:3

56:17 69:14 73:15

73:15 77:15,16

83:2,5 89:21 92:6

277:4 320:21

324:6

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89:6 321:18

we'll 11:2 37:13

43:19 49:2 55:11

66:15,17,21 72:16

80:16 83:9 88:8

93:19 134:12

135:14 155:3

202:7 203:9

206:20,21 233:22

234:11 237:18,19

256:19 261:21

266:21 267:22

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284:22 288:6

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301:20 302:1,11

306:19 313:16

319:10 328:19

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we're 8:13 20:17

32:22 34:20 35:6

36:7 37:22 55:3

61:7 63:4 80:14

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231:10 243:4,5

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wild 44:12 312:18

wildfires 82:6

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willingness 224:21

winds 324:6

winter 89:8 226:13

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225:1 227:16

229:7,9,12 230:7

260:9,11 261:12

347:17 353:19

393:22 414:11

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227:21 228:7

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world 33:11 60:3

68:15 143:10

154:4 288:19

308:2

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world's 79:4

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worse 183:14 184:4

worth 177:10,16

179:2 189:15

193:1 342:14

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286:20 370:8

wrap 251:11

wrestle 250:16,20

wrestling 243:9

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writers 377:11

writing 157:18

236:19,20

written 8:11 13:2

106:1 108:4 114:6

114:22 118:13

119:18 150:16

168:19 201:6

216:4 217:11,17

218:20 221:12

313:20 314:1

336:3 364:8

400:11 414:9

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X 353:3 395:18

Y

Y 60:7 353:3

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year 26:21 75:8

82:3,19 85:9

88:19 89:17

104:15 147:15

209:18 226:13,17

226:20,22 228:8

230:13 260:4,14

269:3,3 277:16

299:19 311:14,16

324:22 330:7

333:1 334:5,7,16

351:10 378:7,10

378:10,13,16

years 47:20 48:5

57:22 60:9 72:20

74:19,22 104:16

209:16 211:17

228:1 232:3,5

233:3 246:19

260:17 269:1,3

275:11 314:21

315:8 318:5

333:18 351:13

378:6,21 386:21

389:9

yellow 229:12

Yellowstone 74:10

74:11,14 75:5,8

80:17 81:9 82:1

87:8,12 138:11

143:16 324:8

yesterday 126:14

211:13

York 353:2

young 349:4

younger 283:4

Z

Z 353:3

Zach 225:15

268:15 283:18

294:8

Zachar 4:23

ZACHARY 2:16

Zanobetti 276:14

Zartarian 361:13

zero 80:18 135:10

253:20 272:12

287:13 290:22

303:10 304:8

348:20 369:16,17

374:20,22 375:6

zeroed 153:8

Zheng 56:15

zone 55:4

Zurich 79:3

0

0.01 175:2

0.04 281:13

0.06 278:14 300:11

0.07 278:15 300:11

355:4

0.071 371:12

0.075 87:16 355:4

0.08 278:15 282:19

300:11 355:19

0.1 174:21

0.12 87:16 281:13

0.15 167:19

0.2 273:4

0.4 282:19

00.000027 368:22

00.04 355:22

06 379:1

08 378:8,8 379:1
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09 378:16,17

1

1 3:18 5:9 56:2

107:10 108:17

109:1 127:13,22

132:21 133:2

315:18 354:6,9,10

356:15 357:3,5,7

357:9 358:16,17

359:2 360:7

368:22 376:11

377:21

1-1 115:8

1-5 355:3 359:1

1.5 31:4

1:00 127:4

1:40 222:10 223:4

1:48 223:7 224:2

10 4:13 206:22

207:4 221:6,8

272:16 274:1

281:1 367:9

378:17 408:19

412:21

10:00 276:16

10:39 107:1

10:40 106:19

10:56 107:2

100 38:20 62:21

1000 78:9

101 3:15

106 208:1

108 3:19

11 1:9 3:5

11,000 369:5

112 117:14

115 253:22

12 30:12,12,14,15

30:20,20 268:21

269:14 270:20

272:7 285:11

296:6 318:4

326:16 328:4

378:19

12:54 223:6

125 72:20

127 3:20

12866 235:17

13 308:6,10

134 155:22

135 3:22

138 156:20

14 3:7 128:19

308:15 360:20

145 3:22

147 3:23

149 3:23

15 106:19 266:21

280:2 281:1

282:17 308:15

321:15 322:22

338:16 400:17

16 209:16 271:2

278:20 296:6

312:18 414:17

16th 234:9

162 4:1

163 4:2

164 4:2

165 4:4

169 4:5

17 3:9 355:3

170 4:5

176 4:7

178 4:8

18 166:1 282:18

283:4,13,16 298:6

180 4:8

181 4:9

194 4:10

197 4:11

198 4:12

1989 72:21

1992 337:8

1996 308:6 325:18

1997 231:20

1999 72:21

2

2 3:19 23:4 56:2

81:8,8,10 95:20

107:10 112:19

119:12 127:13,16

127:22 131:14

136:13 147:10

207:9 360:10

365:7 366:2,20

369:14 373:10,12

373:14 376:11

387:17

2-22 207:13

2-7 360:20 365:10

2.1 119:17 122:9

2.2 364:22

2.3 207:14

2.7 365:9

20 211:16 233:3

266:21 272:16

280:4 281:1

308:12,16 321:11

338:16

20/25 145:20

200 4:12 30:16,16

38:21

2000 318:4 339:22

2002 39:17

2004 146:1,7 276:2

310:7 312:1

2005 361:12

2006 31:7 33:8 75:6

89:17 91:1 93:6

93:10 96:17

212:13,19 269:2,4

271:8 275:11

277:6 333:2 334:5

378:7 386:21

387:18 414:3

2006-2008 414:4

2007 74:17 150:16

150:16 275:13

330:2 336:22

337:15

2008 40:1 45:1,2,5

48:3 52:3 114:9

114:11 126:10

220:11 234:7

260:15 269:4,4

275:11 276:15

277:7 311:4

386:22 387:6,18

414:3

2008-2010 105:2

2009 42:18 312:9

314:17 315:12

316:9,14 324:16

337:9 340:4

378:15

2010 69:6 83:4

269:2,4 271:8

334:6 337:2,16

369:10 378:8,15

386:21,22 387:6

2011 74:17 337:9

351:11

2012 1:9 104:13,21

115:16 116:10

309:18 337:11,12

337:14 338:2,9

341:10 351:9

376:17

2013 260:5,16

2014 227:1

207 4:14

21 81:9

213 4:14

215 122:22

22 3:9

223 4:15

224 4:18

23 337:19

233 124:8

235 124:21

237 4:20 125:21

24 121:11 286:5

25 192:2 321:13

322:21 326:20,22

328:8

25th 274:16

27 121:11 210:3

308:7

27/29 365:10

278 4:22,23

294 4:23

3

3 3:21 5:9 23:19

56:1,2 127:13

135:15,17 138:7

143:4 144:9,12

145:6 149:5

155:18 159:10

163:19 207:10,22

210:3 354:6

366:17 367:8

373:10,13 376:11

377:21

3-hour 122:6

3-147 90:7 92:9

3-22 373:14

3-8 367:9

3.1 32:11 136:12

208:1

3.11 33:21

3.16 33:16

3.4.3 91:16

3.7 159:21

3:44 354:2

3:57 354:3

30 51:2 266:9,10

272:14 279:22

321:7,15 322:22

302 5:1

307 5:2

31 209:7

313 5:2

319 5:3

323 5:4

328 5:4

334 145:19

336 5:5

342 5:5

348 5:6

35 282:19 283:4,16

354 5:10

357 5:10,11

36 311:10

36,310 368:22

378 5:13

38 3:11

382 5:13

386 5:14

4

4 4:1 5:12 23:13
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4B 329:14

4-1 387:16

4-2 387:16

4-46 325:18

4-6 299:6

4.4.2 162:10

40 272:14 280:4

328:11 367:15

40s 321:6

400 5:17

410 5:19

415 5:20

42 121:11,11

423 5:22

43 3:12 72:20

45 60:8 68:18

49 3:12

5

5 4:4 5:16 24:3,5

89:6 164:19

175:20 268:15

273:6 283:13

292:14 329:16

359:1 386:19

400:18 401:2

5B 329:18 330:11

5-51 402:19

5.2.3.1 169:13

5.6.1 405:22

5.7 169:18

5:00 222:11 400:20

5:03 423:14

50 30:21,21 68:19

69:2,21 73:19

74:17 79:16 80:21

80:22 81:11

222:18 324:10

326:17,20,22

327:5 328:6,8

333:7

50th 274:16

500 1:12 74:18

51 74:12

528 169:13

53 74:12

54 130:7

55 3:13 321:13

322:21

56 210:3

59 337:206 6 3:4 4:6 24:6,9

81:8 135:10

175:21 190:7

193:20 268:15

359:2 387:9

6-15 341:3

6-8 341:3 414:3

6.6 281:7,20 282:5

6:00 276:16 422:15

422:20

60 45:3,8 47:21

355:8

60's 214:13

600,000 44:16

63 211:2

65 74:6,11 75:18

278:18 350:20

67 3:13

7

7 4:6 24:9 75:6

76:11 175:21

190:7 193:20

268:16

7/10 174:22

70 45:3 47:22

350:21 355:8

700 369:5

71 112:19

72 3:14

720 74:19

729 253:20

75 45:2 47:22 61:21

160:11 269:13

330:2,10

75th 274:16

8

8 4:10 75:6 97:16

179:4 205:11

206:20 268:17

293:15 418:3,7

8-hour 121:22

145:14

8.1 28:6 113:13

8.5 28:15

8:30 422:10

80 60:8 211:21

301:14 340:6

82 74:4 75:14

88 3:14

9

9 4:13 134:17 135:5

206:21 207:4

208:7 221:5 299:3

357:21

9-17 214:2

9.2 208:9

9.7 220:6

9:00 1:13

9:02 6:2

90 141:17 236:10

90s 279:1

912 218:21

93 3:15

95 315:2

95th 274:17,21

308:14

967 219:19

99th 308:17
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

481

Clean Air Scientific Advisory

Committee Ozone Review Panel

US EPA

09-11-12

Raleigh, NC