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

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## U.S. ENVIRONMENTAL PROTECTION AGENCY

+ + + + + CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

OZONE REVIEW PANEL

+ + + + +

PUBLIC MEETING

+ + + + + 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 SUH202-234-4433 Neal R. Gross & Co., Inc. Page 2

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

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF PRESENT: ANGELA NUGENT, Designated Federal Officer VANESSA VU, Director, SAB Staff Office 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 Page 3

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 Page 4 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 Page 5

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 . . . . . . . . . . . . . . . . . . .423202-234-4433 Neal R. Gross & Co., Inc. Page 6

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

Page 7 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 Page 8 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. Page 9

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 Vu202-234-4433 Neal R. Gross & Co., Inc. Page 10 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 Page 11 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 Page 12 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, Page 13 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 and202-234-4433 Neal R. Gross & Co., Inc. Page 14 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 Page 15 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 Page 16

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. Page 17 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 making202-234-4433 Neal R. Gross & Co., Inc. Page 18 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 Page 19 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 Page 20

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 Page 21

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.202-234-4433 Neal R. Gross & Co., Inc. Page 22 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 Page 23 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 Page 24 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 Page 25 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 evidence202-234-4433 Neal R. Gross & Co., Inc. Page 26 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 Page 27 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 Page 28

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. Page 29

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 the202-234-4433 Neal R. Gross & Co., Inc. Page 30 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 Page 31 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 Page 32 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 Page 33 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 highest202-234-4433 Neal R. Gross & Co., Inc. Page 34 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 Page 35 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. Page 36 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 Page 37 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 ready202-234-4433 Neal R. Gross & Co., Inc. Page 38 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 Page 39

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. Page 40 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 Page 41 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 effects202-234-4433 Neal R. Gross & Co., Inc. Page 42 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 Page 43

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 Page 44 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 Page 45

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 comprehensive202-234-4433 Neal R. Gross & Co., Inc. Page 46 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 Page 47 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 Page 48 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. Page 49 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.202-234-4433 Neal R. Gross & Co., Inc. Page 50 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 Page 51 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 Page 52 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 Page 53

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 for202-234-4433 Neal R. Gross & Co., Inc. Page 54 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 Page 55

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. Page 56 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 Page 57 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. So202-234-4433 Neal R. Gross & Co., Inc. Page 58

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 Page 59 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 Page 60 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 Page 61 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.202-234-4433 Neal R. Gross & Co., Inc. Page 62 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 Page 63 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 Page 64

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 Page 65 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'm202-234-4433 Neal R. Gross & Co., Inc. Page 66 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. Page 67

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 Page 68 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 Page 69 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 event202-234-4433 Neal R. Gross & Co., Inc. Page 70 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 Page 71 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. Page 72 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 Page 73 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 that202-234-4433 Neal R. Gross & Co., Inc. Page 74 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, Page 75 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 Page 76 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 Page 77 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.202-234-4433 Neal R. Gross & Co., Inc. Page 78 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? Page 79

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 Page 80 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. Page 81 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 low202-234-4433 Neal R. Gross & Co., Inc. Page 82 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 Page 83 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 Page 84 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 Page 85 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 area202-234-4433 Neal R. Gross & Co., Inc. Page 86 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 Page 87 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 Page 88

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 Page 89 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 result202-234-4433 Neal R. Gross & Co., Inc. Page 90

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 Page 91 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 Page 92 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 Page 93

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 American202-234-4433 Neal R. Gross & Co., Inc. Page 94 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, Page 95 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 Page 96 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 Page 97

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 to202-234-4433 Neal R. Gross & Co., Inc. Page 98

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 Page 99 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 Page 100 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 Page 101

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. But202-234-4433 Neal R. Gross & Co., Inc. Page 102 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 Page 103 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 Page 104 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 itPage 105

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 additional202-234-4433 Neal R. Gross & Co., Inc. Page 106

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 Page 107

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. Page 108 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 Page 109 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 early202-234-4433 Neal R. Gross & Co., Inc. Page 110 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 Page 111 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. Page 112 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 Page 113 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 reader202-234-4433 Neal R. Gross & Co., Inc. Page 114 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 Page 115 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. Page 116 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 Page 117 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, is202-234-4433 Neal R. Gross & Co., Inc. Page 118 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 Page 119 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 Page 120 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 Page 121 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 so202-234-4433 Neal R. Gross & Co., Inc. Page 122

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 Page 123 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 Page 124 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 Page 125 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.202-234-4433 Neal R. Gross & Co., Inc. Page 126 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 Page 127

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 Page 128 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 Page 129

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. So202-234-4433 Neal R. Gross & Co., Inc. Page 130 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, Page 131 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. Page 132 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 Page 133 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 I202-234-4433 Neal R. Gross & Co., Inc. Page 134 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 Page 135

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 McDonnell9 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 Page 136

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 Page 137 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 we202-234-4433 Neal R. Gross & Co., Inc. Page 138 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. Page 139

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 Page 140 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 Page 141 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 little202-234-4433 Neal R. Gross & Co., Inc. Page 142 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 Page 143 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 Page 144 1 highly non-linear problem. And I'm not using2 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? Page 145

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 the202-234-4433 Neal R. Gross & Co., Inc. Page 146 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 Page 147

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 Page 148 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. Page 149

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, which202-234-4433 Neal R. Gross & Co., Inc. Page 150 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 Page 151 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 Page 152

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 Page 153 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 zeroed9 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?202-234-4433 Neal R. Gross & Co., Inc. Page 154 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 Page 155

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 Page 156 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. Page 157 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 a202-234-4433 Neal R. Gross & Co., Inc. Page 158 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 Page 159

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 Page 160 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 Page 161 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 this202-234-4433 Neal R. Gross & Co., Inc. Page 162 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 Page 163 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 Page 164 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 Page 165

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 whole202-234-4433 Neal R. Gross & Co., Inc. Page 166 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 Page 167 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 Page 1681 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 Page 169 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 of202-234-4433 Neal R. Gross & Co., Inc. Page 170 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 Page 171 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, Page 172 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 Page 173 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 magnitude202-234-4433 Neal R. Gross & Co., Inc. Page 174 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 Page 175 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? Page 176 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 Page 177 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 if202-234-4433 Neal R. Gross & Co., Inc. Page 178 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. Page 179

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 Page 180 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 Page 181 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 fair202-234-4433 Neal R. Gross & Co., Inc. Page 182 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 Page 183

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 not19 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 Page 184 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 Page 185 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.202-234-4433 Neal R. Gross & Co., Inc. Page 186 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 to4 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 Page 187

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 Page 188 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. Page 189

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.202-234-4433 Neal R. Gross & Co., Inc. Page 190 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, Page 191 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 Page 192 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 Page 193 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 think202-234-4433 Neal R. Gross & Co., Inc. Page 194 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 Page 195 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 Page 196 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 Page 197 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 exposure202-234-4433 Neal R. Gross & Co., Inc. Page 198 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 Page 199 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 Page 200 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. Page 201

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 brought202-234-4433 Neal R. Gross & Co., Inc. Page 202

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 Page 203

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 Page 204 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 Page 205 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 suddenly202-234-4433 Neal R. Gross & Co., Inc. Page 206 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 Page 207 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 Page 208 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 Page 209

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 change202-234-4433 Neal R. Gross & Co., Inc. Page 210 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 Page 211 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, Page 212 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 Page 213 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 agricultural202-234-4433 Neal R. Gross & Co., Inc. Page 214 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 Page 215 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. Page 216 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 Page 217 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 way202-234-4433 Neal R. Gross & Co., Inc. Page 218 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 Page 219

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) Page 220 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 thePage 221

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 that202-234-4433 Neal R. Gross & Co., Inc. Page 222

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 Page 223 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.)

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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 Page 225 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. Ben202-234-4433 Neal R. Gross & Co., Inc. Page 226 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 Page 227

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 Page 228 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 Page 229

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.202-234-4433 Neal R. Gross & Co., Inc. Page 230 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 Page 231

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 Page 232 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 Page 233 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 be202-234-4433 Neal R. Gross & Co., Inc. Page 234 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, Page 235 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 Page 236 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 Page 237 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.202-234-4433 Neal R. Gross & Co., Inc. Page 238 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 Page 239 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. Page 240 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 Page 241 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 of202-234-4433 Neal R. Gross & Co., Inc. Page 242 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 Page 243 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 Page 244 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 Page 245 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.202-234-4433 Neal R. Gross & Co., Inc. Page 246 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 Page 247 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. Page 248

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 Page 249

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 NAAQS202-234-4433 Neal R. Gross & Co., Inc. Page 250 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 Page 251

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? Page 252 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. Page 253

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?202-234-4433 Neal R. Gross & Co., Inc. Page 254 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 Page 255 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 Page 256 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 Page 257

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 background202-234-4433 Neal R. Gross & Co., Inc. Page 258 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 Page 259 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 Page 260 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 Page 261

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,202-234-4433 Neal R. Gross & Co., Inc. Page 262 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 Page 263

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 Page 264

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 Page 265 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 proposed202-234-4433 Neal R. Gross & Co., Inc. Page 266 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. Page 267

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. Page 268 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. Page 269

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 roll202-234-4433 Neal R. Gross & Co., Inc. Page 270 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. Page 271

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 Page 272 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 Page 273 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 ozone202-234-4433 Neal R. Gross & Co., Inc. Page 274 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 Page 275 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 Page 276 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. Page 277

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.202-234-4433 Neal R. Gross & Co., Inc. Page 278 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. Page 279

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 Page 280 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 ofPage 281

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.202-234-4433 Neal R. Gross & Co., Inc. Page 282 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 Page 283 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. Page 284

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 Page 285

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 slide202-234-4433 Neal R. Gross & Co., Inc. Page 286 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 Page 287 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 Page 288 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 Page 289

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 term202-234-4433 Neal R. Gross & Co., Inc. Page 290 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 Page 291

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? Page 292 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 Page 293 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 good202-234-4433 Neal R. Gross & Co., Inc. Page 294 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 Page 295 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 Page 296 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 Page 297 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.202-234-4433 Neal R. Gross & Co., Inc. Page 298 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. Page 299

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. Page 300

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 -- Page 301

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.202-234-4433 Neal R. Gross & Co., Inc. Page 302

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. Page 303

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 Page 304

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 Page 305 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, effect202-234-4433 Neal R. Gross & Co., Inc. Page 306 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? Page 307

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 Page 308

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 Page 309 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 of202-234-4433 Neal R. Gross & Co., Inc. Page 310 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 Page 311 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 Page 312 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. Page 313

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.202-234-4433 Neal R. Gross & Co., Inc. Page 314 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. Page 315

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. Page 316 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 Page 317

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 air202-234-4433 Neal R. Gross & Co., Inc. Page 318 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 Page 319 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 Page 320 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. Page 321

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 similar202-234-4433 Neal R. Gross & Co., Inc. Page 322 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 Page 323

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. Page 324 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. Page 325

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.202-234-4433 Neal R. Gross & Co., Inc. Page 326 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 Page 327

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. Page 328 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 Page 329 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 the202-234-4433 Neal R. Gross & Co., Inc. Page 330 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 Page 331 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. EPA6 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 Page 332 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 Page 333 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's202-234-4433 Neal R. Gross & Co., Inc. Page 334

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 Page 335

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 Page 336 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 Page 337 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 and202-234-4433 Neal R. Gross & Co., Inc. Page 338

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. Page 339

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 Page 340 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 Page 341

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.202-234-4433 Neal R. Gross & Co., Inc. Page 342 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. Page 343

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. Page 344 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 Page 345

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 is202-234-4433 Neal R. Gross & Co., Inc. Page 346

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 Page 347

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 Page 348 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 Page 349

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.202-234-4433 Neal R. Gross & Co., Inc. Page 350 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 Page 351 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. Page 352 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 Page 353 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.202-234-4433 Neal R. Gross & Co., Inc. Page 354 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, Page 355 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. Page 356 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. Page 357

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 the202-234-4433 Neal R. Gross & Co., Inc. Page 358 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 Page 359 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 Page 360 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 Page 361 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.202-234-4433 Neal R. Gross & Co., Inc. Page 362 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. Page 363 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 Page 364 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 Page 365 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.202-234-4433 Neal R. Gross & Co., Inc. Page 366 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 Page 367 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 Page 368 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 Page 369 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 could202-234-4433 Neal R. Gross & Co., Inc. Page 370 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 Page 371

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 Page 372 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 Page 373 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, total202-234-4433 Neal R. Gross & Co., Inc. Page 374 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 Page 375 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? Page 376 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 Page 377 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.202-234-4433 Neal R. Gross & Co., Inc. Page 378 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 Page 379

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 Page 380 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 Page 381 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.202-234-4433 Neal R. Gross & Co., Inc. Page 382 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 Page 383 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. Page 384

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. Page 385

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 better202-234-4433 Neal R. Gross & Co., Inc. Page 386 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, Page 387 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 Page 388 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. Page 389

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 more202-234-4433 Neal R. Gross & Co., Inc. Page 390 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 Page 391 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 Page 392 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 Page 393 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 done202-234-4433 Neal R. Gross & Co., Inc. Page 394

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 Page 395

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. Page 396 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 Page 397 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.202-234-4433 Neal R. Gross & Co., Inc. Page 398 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 Page 399 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 Page 400 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 Page 401 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 of202-234-4433 Neal R. Gross & Co., Inc. Page 402 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 Page 403 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 Page 404 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 Page 405 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.202-234-4433 Neal R. Gross & Co., Inc. Page 406 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 avertingPage 407

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 Page 408 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 -- Page 409

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.202-234-4433 Neal R. Gross & Co., Inc. Page 410

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 Page 411

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 Page 412 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 Page 413 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.202-234-4433 Neal R. Gross & Co., Inc. Page 414 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 Page 415 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 Page 416 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 Page 417 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. I202-234-4433 Neal R. Gross & Co., Inc. Page 418 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 Page 419 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 Page 420 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 Page 421 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, but202-234-4433 Neal R. Gross & Co., Inc. Page 422

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 Page 423 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.)

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