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

+ + + + + CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

OZONE REVIEW PANEL

+ + + + +

PUBLIC MEETING

+ + + + + THURSDAY, SEPTEMBER 13, 2012

+ + + + + The meeting convened in State Ballrooms A and B of the Marriott City Center, 500 Fayetteville Street, Raleigh, North Carolina, at 8:30 a.m., Jonathan Samet, CASAC Chair, presiding.

CASAC MEMBERS PRESENT:

JONATHAN M. SAMET, Chair

GEORGE A. ALLEN ANA DIEZ-ROUX HELEN SUH (via telephone) KATHLEEN WEATHERS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 2 PANEL MEMBERS PRESENT: ED AVOL MICHELLE BELL DAVID CHOCK WILLIAM MICHAEL FOSTER DAVID GRANTZ JACK HARKEMA DANIEL JACOB (via telephone) 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 BRYAN HUBBELL, OAQPS SCOTT JENKINS, OAQPS KAREN MARTIN, OAQPS VICKI SANDIFORD, OAQPS SUSAN STONE, OAQPS KAREN WESSON, OAQPS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 3 C-O-N-T-E-N-T-S PAGE Agency Presentation on Policy Assessment Overview by Karen Martin. . . . . . . . . . . 10 by Ms. Susan Stone. . . . . . . . . . . 24 by Dr. Scott Jenkins. . . . . . . . . . 31 by Ms. Vicki Sandiford. . . . . . . . . 44

Public Comments by Jon Heuss. . . . . . . . . . . . . . 72 by Roger McClennan. . . . . . . . . . . 78 Panel Discussion on Policy Assessment Chapter 1 - Introduction by Dr. Daniel Jacob . . . . . . . . . . 84 by Mr. George Allen . . . . . . . . . . 89 by Dr. David Chock. . . . . . . . . . . 91 Chapter 2 - Overview of Health by Dr. Michael Bell . . . . . . . . . . 93 by Dr. Sverre Vedal . . . . . . . . . . 96 by Dr. Jack Harkema . . . . . . . . . . 99 by Dr. Joe Brain Chapter 3 - Health Exposure and Risk Assessments by Dr. Helen Suh. . . . . . . . . . . .112 by Dr. Michael Foster . . . . . . . . .114 by Dr. James Ultman . . . . . . . . . .116 Chapter 4 - Preliminary Conclusions on the Primary NAAQS by Dr. Chris Frey . . . . . . . . . . .123 by Mr. Ed Avol. . . . . . . . . . . . .134 by Dr. Fred Miller. . . . . . . . . . .138 by Dr. Ana Diez-Roux Chapter 5 - Welfare Evidence by Dr. Kathleen Weathers. . . . . . . .155 by Dr. Peter Woodbury . . . . . . . . .157 by Dr. Howard Neufeld . . . . . . . . .160

### 202-234-4433 Neal R. Gross & Co., Inc. Page 4

Chapter 6 - Welfare Exposure and Risk

Assessments by Dr. Kathleen Weathers. . . . . . . .165 by Dr. Peter Woodbury . . . . . . . . .167 by Dr. Howard Neufeld . . . . . . . . .170

by Dr. David Grantz . . . . . . . . . .174

Ch. 7 - Preliminary Conclusions on the Secondary NAAQS by Dr. Kathleen Weathers. . . . . . . .180 by Dr. Peter Woodbury . . . . . . . . .181 by Dr. Howard Neufeld . . . . . . . . .181

by Dr. David Grantz . . . . . . . . . .182

### 202-234-4433 Neal R. Gross & Co., Inc. Page 5 1 P-R-O-C-E-E-D-I-N-G-S 2 (8:30 a.m.) 3 DR. NUGENT: Again, this is Angela 4 Nugent, and it's my pleasure to reconvene the 5 CASAC Ozone Review Panel for this last day of 6 its meeting. 7 Two administrative items, the 8 first one is, I think, our Chair is going to 9 comment on the plans for the day, and when we 10 might wrap up. 11 But, keeping that in mind, I know 12 many of you are heading for other destinations 13 this afternoon. And our contractors outside 14 are ready to see if they can assist you to get 15 a taxi to the airport. 16 So at the break, if you have the 17 desire for a taxi or transportation, sign up 18 with them. And if you have any special needs 19 about when you're leaving, let them know that 20 too. So that's one thing. 21 And the other item is for members 22 of the public, who have an interest to provide

### 202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 additional clarifying comments, no more than 2 three minutes. After today's Panel 3 deliberations, please, contact me, if you have 4 not already done so. 5 And we ask members of the public, 6 who wish to do that to stay tuned to our 7 agenda and how we're working through it, 8 because the clarifying comments from the 9 public may happen a little earlier than 12:30. 10 So those were my two thoughts. I know Vanessa 11 has an important administrative item. 12 DR. VU: Good morning. As you may 13 know, this CASAC Meeting is the last meeting 14 that is chaired by Dr. Jonathan Samet. And I 15 would like to take this opportunity to, you 16 know, it's my honor and privilege to present 17 to Dr. Jon Samet a tribute of appreciation 18 from Administrator Lisa Jackson. 19 With that, Jon, here it is for 20 you. I hope you can hang it on your wall in 21 your office back home. The tribute, basically 22 says that, "U.S. EPA tribute of appreciation

### 202-234-4433 Neal R. Gross & Co., Inc. Page 7 1 presented to Dr. Jonathan M. Samet, in 2 recognition of public service on the EPA's 3 Science Advisory Board and Chair of the EPA 4 Clean Air Scientific Advisory Committee 2008 5 to 2012, signed Lisa P. Jackson, 6 Administrator." Thank you. 7 (Applause.) 8 DR. VU: In addition to the 9 Certificate of Appreciation, Administrator 10 Jackson also wrote you a letter, a personal 11 letter, thanking you. 12 And just an inscription on the 13 letter, she also said thank you for, you have 14 done great service to EPA and to our Nation. 15 Thank you again. 16 CHAIR SAMET: Okay. Thank you, 17 Vanessa. And this has been great fun. Don't 18 worry, I'm not going to make a speech. 19 And I have one prediction for you. 20 There will be another Chair of CASAC. This 21 may be picked at random, in fact, so watch 22 out. But I think this has actually been great

### 202-234-4433 Neal R. Gross & Co., Inc. Page 8 1 fun. 2 I'm impressed by the tremendous 3 amount of work that we all do together, the 4 EPA, this Committee, the Public, who provide

5 comments. 6 And I think the challenge and the 7 fun for me has been trying to put together so 8 many different pieces of so many kinds of 9 information and see what the story is. 10 Sometimes the story is clear, sometimes it's

11 not. 12 But, you know, I think our job, 13 CASAC's is to help make that story as clear 14 and as strong possible. So I will certainly 15 be watching what happens as you move forward, 16 and we'll see whether I'm sitting around the 17 table with you back here. 18 So, thanks, and thank the 19 Administrator, and I'll find a nice spot for 20 this tribute. So, thank you very much, and 21 let's get on with the work. 22 And just a comment, I think, from

### 202-234-4433 Neal R. Gross & Co., Inc. Page 9 1 the number of people who've come up to me, 2 which is like everybody who doesn't live in 3 North Carolina, you've all said that you're 4 leaving before the meeting actually ends. 5 Let's see, who is in sort of the 6 pre-getting out of here before noon group? Or 7 roughly noon? Yes, so, okay. So I think 8 that's helpful. I think we'll certainly 9 target getting done before noon, and I suspect 10 that we can. So why don't we get on with 11 hearing from EPA then? 12 MS. WEGMAN: Okay. Great. Good 13 morning, everybody. And let me add my thanks 14 to what Vanessa said, Jon, for all the work 15 you've done. 16 We're so appreciative of your 17 leadership with CASAC over these past several 18 years. We are pleased that this morning Karen 19 Martin feels well enough to join us. 20 And she will be kicking off the 21 presentation on the Policy Assessment and then 22 we have also Susan Stone, Scott Jenkins, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 Vicki Sandiford up here to talk about 2 different parts of the Policy Assessment, as 3 we go through the presentation and the 4 discussion. So I'm going to turn it over to

5 Karen. 6 DR. MARTIN: Okay. Good morning. 7 While I wasn't here in person the last couple 8 of days, I listened to all your discussions, 9 so at least I come armed with understanding 10 what you all have been talking about. 11 Let me begin by just providing the 12 overview for the Policy Assessment. And this 13 next slide is showing the overview, as you've 14 all seen, as to how the Policy Assessment is 15 organized. 16 And what I want to do is just 17 discuss a little bit about Chapter 1, and then 18 I'm going to turn it over to the rest of the 19 team, Susan, Scott, and Vicki, to discuss the

20 rest. 21 What I want to do is take just a 22 little bit of time on the first bullet on this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 11 1 page about the introductory chapter. And 2 that's to provide some context for a lot of 3 the discussion that's gone on the last couple 4 of days with regard to our favorite subject of 5 background, and how it's come into play in the 6 past, how it might be considered in this 7 review, and the whys of why it's been done how 8 it was in the past, and why we might change in 9 how we approach it in this review. 10 And it struck me that, while the 11 opening remarks on Tuesday, that Bryan offered 12 about this had something to say on that topic, 13 it might not have gone into enough background 14 to make it as understandable as would have 15 been helpful. 16 So I thought I'd just talk a 17 little bit about some of the things we might 18 have said in that introductory part of the 19 chapter, but we didn't, but we will certainly 20 consider adding to the second draft of this

21 document. 22 And in that regard, I'd like to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 12 1 take a step back in time and reflect upon the 2 issue of considering attainability and setting 3 the standard, and the extent to which the case 4 law that arise from the litigation following 5 most all of the Agency's decisions on the 6 NAAQS has addressed that issue. 7 And for that, we need to go back 8 to 1979 for the ozone decision when the one 9 hour 0.12 part per million Standard was set. 10 That standard was challenged for many reasons. 11 One of which was that, we should have, but 12 didn't, consider whether or not that standard 13 would be attainable. 14 And a finer point was put on that 15 in that litigation by one petitioner saying, 16 furthermore, in my area, in my city, it 17 wouldn't be attainable just because of natural 18 sources of emissions, precursory emissions. 19 And the court very specifically 20 engaged in those arguments, and the court said 21 that, it would defeat congressional intent of 22 the Act to allow attainability to be a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 13 1 relevant consideration. 2 That basically, the legislative 3 history makes clear that the Act intended 4 these NAAQS to be not lowest common 5 denominator standards as to what everyone 6 could meet everywhere at all times, but 7 rather, standards that were truly defined to 8 be what is protective of public health with an 9 adequate margin of safety from the health side 10 and standards that are intended to protect 11 welfare from known and anticipated adverse

12 effects. 13 So that the court recognized that 14 attainability would defeat that purpose and 15 therefore it wasn't a relevant consideration. 16 It engaged further, even on the 17 natural issue. And it made the point that a 18 national standard, like the NAAQS intended to 19 broadly protect public health, wasn't 20 appropriate to tailor that standard to address 21 circumstances in any one particular area. 22 And this, obviously, has resonance

### 202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 in looking at our much more sophisticated 2 understanding of the issue of background today 3 than certainly what we had in time gone by, 4 where we can observe peak levels occurring in 5 individual locations at infrequent points in 6 time. 7 And to suggest that somehow those 8 peak concentrations should in some way form a 9 constraint on what the Agency defines to be a 10 standard that is broadly protective of public 11 health would again, not be consistent with the 12 intent of the Act. 13 So that's sort of the long-term 14 history. In bringing us up a little more 15 recently to look at the '97 Ozone Review. In 16 that Review, the Agency brought in the issue 17 of background, both in the concept of looking 18 at calculating risks in excess of background. 19 And it also explicitly brought in 20 background as part of the factors in reaching 21 a final decision on the level of the standard. 22 With regard to the issue about

### 202-234-4433 Neal R. Gross & Co., Inc. Page 15 1 looking at risk above background in that 2 review, I'll note a couple things. At that 3 time, there was a very simplistic 4 understanding of background. We didn't have 5 the global models to apply, and it was defined 6 to be one level everywhere at all times. 7 And further, and importantly, I 8 think, in looking at the much more limited 9 epidemiologic evidence and clinical evidence 10 in that review, we were faced with a situation 11 where we had absolutely no clinical evidence 12 below a level of 0.08, and the epi evidence we 13 had was interpreted expressly by CASAC as 14 providing evidence of effects that likely 15 extend down to background. And that's a quote 16 from the CASAC advice in that review. 17 So what happened in that review 18 was there was an interpretation by the Agency, 19 by the CASAC Panel advising the Agency, that 20 it was reasonable to interpret the evidence as 21 providing associations down to background. 22 And that set up the notion that it

### 202-234-4433 Neal R. Gross & Co., Inc. Page 16 1 was therefore reasonable to estimate risk in 2 excess of background. And that when the 3 Agency then engaged in the question of asking: 4 is the then current standard adequate, and 5 looking not only at the evidence, but also at 6 the risk estimates, and asking the question: 7 what is the risk remaining upon attaining the 8 current standard? It seemed reasonable enough 9 to estimate that risk as risk in excess of 10 background. 11 In addition, in reaching that 12 final decision, the Agency was faced with 13 looking at three different levels, 0.09, 0.08, 14 0.07, that was the range the then staff paper 15 had set up. That was the range that the CASAC 16 Advisory Panel, at that time, felt was 17 appropriate to consider. 18 And the Agency addressed all of 19 the evidence-based reasons and the risk-based 20 reasons for why 0.08 was more appropriate than

21 0.09. 22 And then it engaged in the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 17 1 question of: should we go down to 0.07? And 2 there were three reasons articulated why the 3 Administrator, at that time, decided it was 4 not appropriate to go down to that level. 5 And the three reasons very 6 succinctly are: first of all, not one member 7 of the CASAC Panel supported going to that

8 level. 9 Second of all, it talked about the 10 most certain evidence was the least serious. 11 There was no evidence from clinical studies 12 below 0.08 and that the more serious effects 13 were much more uncertain. 14 And the third point, in the face 15 of that scientific uncertainty, the Agency

16 also observed that a level of 0.07 was closer 17 to peak background levels that infrequently 18 occurred in some places.

19 And for all those reasons taken 20 together, the Agency made the decision to set 21 the standard at the level of 0.08 that it did. 22 The court engaged in litigation on

### 202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 that decision, and I'm sure you're aware, 2 there was a tremendous amount of litigation on 3 this decision. But some of the points 4 specifically took on the issue of: were they 5 valid considerations to use as the basis for 6 the standard? And the court decided that in 7 fact they were. 8 The court decided that the most 9 compelling information was the science 10 information and the uncertainty and the 11 absence of evidence below a certain level. 12 But it allowed as to how that in 13 the face of that uncertainty, it wasn't 14 unreasonable for the Agency to consider the 15 other factors, that it was certainly 16 appropriate for Agency to put weight on 17 CASAC's views. 18 And it was not inappropriate to 19 consider the other issues about background, 20 again, in the face of the scientific 21 uncertainty. 22 So when we think about how to take

### 202-234-4433 Neal R. Gross & Co., Inc. Page 19 1 background into consideration in reviews, our 2 understanding of it is informed by this 3 history of how it is evolved through Agency's 4 thinking and through litigation and court 5 opinions on the reasonableness of that 6 thinking. 7 So, sorry for that diversion, but 8 it just seemed appropriate, given everything 9 I had been listening to, to sort of lay that

10 out. 11 Now, when we come to this review, 12 the question is, why wouldn't we do things the 13 same way? Why wouldn't we continue to 14 estimate risks above background like we did

15 before? 16 Well, I'd make the observation, 17 that in this particular case, we don't have an 18 ISA, or a CASAC Panel saying, we only having 19 evidence effects down to background. 20 We have science evaluation and 21 interpretation saying, we don't discern a 22 threshold, and it's likely that these

### 202-234-4433 Neal R. Gross & Co., Inc. Page 20 1 associations extend down to the lowest levels

2 that we see. 3 So we're not faced with the same 4 kind of interpretation of the science, that in 5 the first place would have set us up to do 6 risk above background. 7 And therefore, we would judge it's 8 more appropriate, based on the current 9 interpretation of the much, much broader body 10 of epidemiologic evidence available today, to 11 think about calculating total risk and not 12 truncating it at some background level, which 13 we now understand to be quite a complex 14 spatially and temporally variable 15 consideration. 16 And one last point I would like to 17 make about that, is that when you look at the 18 rationales for NAAQS' decisions, not just in 19 ozone, but in other reviews as well, where 20 background isn't really particularly relevant, 21 but where we have to parse the risk 22 information.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 21 1 What those decisions typically do 2 is they look at the question first of, what 3 does the risk information tell us about the 4 adequacy of the current standard? 5 And there in the past, and whether 6 you define it as risk above background or 7 total risk, you still want to look at what is 8 the risk remaining upon meeting the current

9 standard. 10 But to the extent the Agency then 11 concludes that that information calls into 12 question the adequacy of the current standard, 13 and therefore looks at alternative standards. 14 The way in which we've 15 historically used that risk information is to 16 look at what is the reduction in risk 17 associated with going to an alternative 18 standard, relative to the risk we observe with

19 the current standard? 20 And once you start using the risk 21 information to look at reduction in risk, the 22 differences in risk, then it matters very

### 202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 little whether your risk calculations were 2 done looking at total risk, or looking at risk 3 above background. 4 Because when you subtract those 5 numbers, the risk attributable down to the 6 lower levels or down to background basically

7 subtract out. 8 In other words, that difference in 9 risk is not substantially sensitive to whether 10 or not you estimated risk down to some very 11 low level, or down to a background level. 12 And that was the point that was 13 being made. In discussing the risk assessment 14 before, that the primary focus is on risk 15 reduction, once we start looking at 16 alternative standards, and therefore it's not 17 particularly sensitive to this question. 18 So I didn't want to belabor that 19 point any more, but it seemed worth trying to 20 bring that history in. Because that's 21 certainly a context that frames our 22 considerations of how we approach the task we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 23 1 have in terms of doing risk assessments and 2 doing the policy assessment. And it became 3 clear, listening, that that history hadn't 4 been brought into this policy assessment and 5 perhaps would be worth touching upon here. 6 Let me just finish my remarks by 7 completing the information on this chart. And 8 that's just to say that that first chapter 9 does now include a discussion of air quality 10 and focuses very heavily on background. 11 And just to summarize how one 12 would generally interpret the information 13 presented there, is to say that, oh, in 14 general, background concentrations are 15 relatively low across much of the U.S., 16 including the more heavily populated areas in 17 the East and particularly,\ California. 18 That anthropogenic emission 19 sources are the dominant contributors to eight 20 hour daily max concentrations on days where 21 ozone concentrations are the highest. 22 And where background

### 202-234-4433 Neal R. Gross & Co., Inc. Page 24 1 concentrations are highest, in the Western 2 U.S. and particularly at higher elevations, 3 key sources contributing to those episodic 4 peak concentrations include wildfires, 5 stratospheric intrusion, and intercontinental 6 transport. So with that, I'll turn it over to

7 Susan. 8 MS. STONE: Thank you, Karen. In 9 considering the policy-relevant evidence to 10 pull forward into the Policy Assessment, we 11 look to the weight of evidence conclusions 12 regarding causality in the ISA. 13 The primary focus is on those 14 health end points for which the ISA concludes 15 the relationship is causal, or likely to be

16 causal. 17 And these include respiratory 18 morbidity and mortality effects following 19 short and long-term exposures and total 20 mortality following short-term exposures. 21 What this means with regards to 22 controlled human exposure studies, is we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 25 1 focused on the large body of evidence 2 available in the last review. 3 This is evidence primarily above 4 80 parts per billion, which showed lung 5 function decrements, respiratory symptoms, 6 pulmonary inflammation, increased airway 7 responsiveness, and decreased lung host

8 defenses. 9 There was also evidence of lung 10 function decrements down to 60 parts per 11 billion. These were, of course, the Adams 12 studies. 13 When we looked at new studies we 14 focused on studies that evaluated effects

15 below the level of the current standard. And 16 these provided additional information about 17 lung function decrements at 60 parts per 18 billion. And new information about pulmonary 19 inflammation and respiratory symptoms at 60 20 and 70 parts per billion, respectively. 21 As we did in the last review, we 22 considered not only the group mean lung

### 202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 function decrements, but also the proportion 2 of subjects who experience moderate lung 3 function decrements greater than or equal to 4 a ten percent decrement in FEV1.

5 These are decrements that could be 6 clinically relevant in people with lung 7 disease. And the ISA reports that at 60 parts 8 per billion, on average ten percent of 9 subjects experienced these decrements of ten 10 percent or greater in FEV1.

11 The ISA concludes that across the 12 end points, not only lung function decrements, 13 but also pulmonary inflammation and 14 respiratory symptoms, that studies conducted 15 in healthy subjects likely underestimate the 16 magnitude and seriousness of effects in at 17 risk populations. 18 With respect to epidemiological 19 studies, studies of short-term exposures, 20 these are hours to weeks. In the 2006 Air 21 Quality Criteria document, it was concluded 22 that there was a causal relationship between

### 202-234-4433 Neal R. Gross & Co., Inc. Page 27 1 ozone exposure and the respiratory morbidity 2 effects that you see listed here and a likely 3 causal relationship between ozone and total 4 non-accidental mortality. 5 The new multi-city and single city 6 studies reinforce the previous evidence. 7 Reporting ozone respiratory morbidity and 8 mortality effects, including hospital 9 admissions and emergency department visits. 10 And the recent studies continue to 11 report no evidence of a discernable threshold 12 down to levels that are common in the U.S. in 13 the ozone season. These are levels greater 14 than 20 parts per billion, supporting 15 associations between the ozone and these

16 effects at levels below the current standard. 17 The Policy Assessment discusses 18 key issues related to the interpretation of 19 Epidemiologic studies, including confounding 20 by co-pollutants, effect modification, the 21 biological plausibility of the lag structure, 22 and the shape of the concentration response

### 202-234-4433 Neal R. Gross & Co., Inc. Page 28 1 function. 2 Important new evidence in this 3 review is evidence of effects of long-term 4 exposures. These are exposures of 30 days or 5 greater. 6 In the last review, there was 7 limited evidence of this, primarily from 8 toxicology studies. In this review there is 9 new evidence from epidemiologic studies, which 10 reports associations with respiratory effects. 11 Many with effects related to 12 asthma, including new onset asthma, first 13 asthma hospitalization, asthma prevalence, 14 asthma severity and control, as well as 15 decrements in pulmonary function, changes in 16 lung structure, and respiratory mortality. 17 Several studies report 18 gene/environment interactions. And these 19 studies of susceptibility genes help shed 20 light on the biological pathways most relevant 21 to the disease. 22 And toxicology studies continue to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 29 1 support the biological plausibility and 2 coherence of the epidemiologic evidence. And 3 so, because, as Lydia and Bryan mentioned, the 4 Policy Assessment does not re-evaluate the 5 science, our charge questions to you are along 6 the lines of, is the presentation of the 7 evidence in the Policy Assessment, does it 8 appropriately reflect the assessment of the 9 science in the ISA? Is it technically sound, 10 clearly communicated and balanced? 11 And so, after we look at the 12 health effects, we consider the public health 13 implications. Thank you, Lydia. I'll turn it

14 over to Scott. 15 And in this we characterize the 16 adversity of the effects, for many effects, 17 clearly they are adverse. The question comes 18 into play when you look at lung function 19 decrements and respiratory symptoms. 20 We used exactly the same criteria 21 for adversity that we did in the last review. 22 These are the American Thoracic Society

### 202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 Adversity Guidelines from 1985 and 2000, and 2 the recommendations of the CASAC Panel in the 3 last two reviews, especially. 4 The discussion of the populations 5 at increased risk focuses on the factors for 6 which the ISA concludes there is adequate 7 evidence of increased risk. 8 This results in the same 9 populations at risk as in the last review, 10 except for the addition of diet as a factor. 11 The ISA concludes that diets with reduced 12 intake of Vitamin C and E increase risk. 13 We have estimated the size of 14 these populations using 2010 data from the

15 U.S. Census and the Bureau of Labor 16 Statistics. And the size of the at risk 17 population is quite large. 18 We have an example here of two 19 non-overlapping groups, children and older 20 adults, which together total more than 110 21 million people in the United States, which is 22 37 percent of the population.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 31 1 In the Policy Assessment there's a 2 short discussion of the new evidence for the 3 impact averting behaviors. The ISA concludes 4 that this evidence suggests that these 5 averting behaviors may effect risk estimates 6 in short-term epi studies in the United 7 States. And now I'd like to turn it over to

8 Scott. 9 DR. JENKINS: Thanks, Susan. So I 10 am aware that we're pushing our time limit 11 here, so I'm going to try to go quickly 12 through the next few slides so Vicki will be 13 able to talk through the welfare slides, as 14 well, before our time runs out. 15 So I'm going to talk through 16 Chapters 3 and 4. And Chapter 3 is, of 17 course, where we bring in the preliminary 18 results of the first draft of the REA. 19 And I won't belabor the slide, 20 just noting that our focus in bringing forward 21 these results is on the preliminary estimates 22 of ozone related exposures and risks that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 32 1 remain after simulating just meeting the

2 current standard. 3 We have the list of exposure and 4 risk end points listed there as sub-bullets. 5 And ranging from the benchmark exceedances to 6 estimates of ozone attributable mortality, 7 hospital admissions, emergency department 8 visits, and respiratory symptoms.

9 As we look forward to the second 10 draft of the Policy Assessment, in addition to 11 these exposure and risk end points we're going 12 to be bringing forward also estimates of the 13 population at risk for ozone-induced lung 14 function decrements. 15 And this is, of course, Chapter 6 16 of the first draft REA, which was sent to the 17 Panel at the same time as the Policy 18 Assessment. So we weren't able to incorporate 19 those estimates into the first draft. 20 In addition to that, we will be -- 21 so the first draft, of course, looks at 22 estimates of exposures and risks with the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 33 1 current standard. 2 In the second draft, we will be 3 looking at exposures and risks remaining after 4 simulating just meeting different alternative 5 standards, as well as what Karen alluded to, 6 which is the incremental changes in risks as 7 you go from one alternative standard to

8 another. 9 In soliciting input from the Panel 10 on this chapter, we are looking for input not 11 only on the way in which we brought forward 12 these estimates of exposures and risks, but 13 also on the utility of the chapter as a whole. 14 Whether it's in part or in whole redundant 15 with what's in Chapter 4 and what's in the 16 REA. And so any feedback from the Panel on 17 that issue would be appreciated. 18 Okay, the next three slides I'm 19 going to be talking through Chapter 4. And 20 Chapter 4 is, of course, when we get to the 21 final Policy Assessment Chapter 4 is where we 22 will be drawing conclusions, staff conclusions

### 202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 on the adequacy of the current standard and on 2 the range of alternatives that are appropriate 3 for consideration by the Administrator. 4 So in the first draft of the 5 Policy Assessment we really deal with three 6 main issues. And I'm going to go through 7 those three issues quickly on the next three 8 slides. 9 The first issue is the adequacy of 10 the current primary NAAQS. So bottom line is 11 that when we look at the available scientific 12 evidence from the third draft ISA, including 13 evidence for effects below the level of the 14 current standard, when we look at the 15 exposure/risk information, particularly the 16 evidence for ozone-related exposures and risks 17 that remain after simulating just meeting the

18 current standard. 19 And when we consider the CASAC 20 advice that we received in the last review and 21 in the reconsideration, all of those together, 22 we considered all of those together, and we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 35 1 reached the preliminary conclusion that they 2 support consideration of revising the current 3 standard in order to increase public health 4 protection against short-term exposures, 5 especially for at risk populations.

6 So as we look forward to the 7 second draft of the Policy Assessment, an 8 additional issue that, I think, we will be 9 spending a lot more time on is the extent to 10 which the current short-term standard provides 11 protection against effects that have been 12 associated with long-term exposures. 13 So, again, we're looking for 14 feedback from the Panel on this conclusion, as 15 well as on the basis for reaching the 16 conclusion. 17 Okay, the second issue I'm going 18 to raise with regard to Chapter 4 is the 19 preliminary conclusions that we reached 20 regarding the additional analyses that 21 appropriate for the second draft of the REA. 22 So just to clarify, what we're not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 36 1 doing here is we're not identifying a range of 2 alternative standards that are appropriate for 3 consideration by the Administrator. What we 4 are doing is reaching conclusions regarding a 5 range of levels that are appropriate for 6 analysis in the REA. 7 So when we get to the second draft 8 of the Policy Assessment, which will, of 9 course, be pulling from the second draft of 10 the REA, we will be able to consider those 11 estimates of exposures and risks with the 12 alternative levels and we will actually be 13 reaching preliminary conclusions regarding the 14 range of alternative standards that are 15 appropriate for consideration by the 16 Administrator. 17 When we talk about alternative 18 ozone levels, we're talking about levels 19 within the context of essentially the current 20 indicator averaging time and form. 21 And when we look at the evidence 22 and when we think about CASAC advice that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 37 1 we've received in the past, what we've 2 concluded or what we noted at first was, in 3 the last review, and in the reconsideration,

4 CASAC recommended that we focus on levels from

5 70 to 60. 6 When we look at the evidence 7 available in the current review, we reached 8 the preliminary conclusion that the new 9 evidence reinforces support for this range, 70 10 to 60. And that, in addition, it supports 11 considering analyzing standard levels somewhat

12 below 60. 13 And so, obviously, this is an 14 issue that we are looking for feedback from 15 the Panel on, you know, to what extent is it 16 appropriate to focus on this range of 60 to

17 70? 18 And to what extent should we go 19 think about analyzing levels below 60, and if 20 so, how far below 60? So those are key 21 issues, obviously, for us as we think about 22 moving to the second draft.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 38 1 And then the last topic I'm going 2 to touch on with regard to Chapter 4 is, it 3 really relates to how we think about air 4 quality information and epidemiologic study 5 locations within the context of making 6 decisions on alternative standard levels that 7 are appropriate. 8 We've got a couple of different 9 approaches that we put forward and that we 10 talk about in the current first draft of the 11 Policy Assessment. And the first approach is 12 to look at ozone design values and study 13 locations. 14 And if you think about this 15 approach in the context of the current 16 standard, it's actually designed to answer a 17 very straightforward, very simple, simplistic 18 question, and that is, do we have associations 19 with mortality or morbidity that have been 20 reported in locations that meet the current

21 standard? 22 You can ask the same question for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 39 1 alternative standards. If the answer to that 2 question is yes, you can imagine that it 3 provides some very compelling evidence 4 regarding the adequacy of the current 5 standard, or the appropriateness of different 6 alternative standards. 7 So this design value approach is 8 really designed to answer that sort of very 9 straightforward and simple question. Now we 10 have gotten some comments, and the pre-meeting 11 comments, to suggest that we have understated 12 the utility of looking at studies, the broader 13 distributions of ozone concentrations and 14 studies in areas that would have violated the

15 current standard. 16 And I think we generally agree 17 with those comments. I think there are some 18 areas where we do sort of paint too stark a 19 picture in terms of the utility of those 20 studies. 21 So I do think as we go forward to 22 the second draft, that's something we will

### 202-234-4433 Neal R. Gross & Co., Inc. Page 40 1 definitely be looking to improve the way we 2 discuss those studies.

3 Because one of the other 4 approaches that we're looking at, is looking 5 at these broader air quality distributions in 6 locations where we have studies that have 7 evaluated concentration response 8 relationships. 9 And so we put forward a couple of 10 examples in this first draft Policy 11 Assessment. And we are looking to refine the 12 approaches that we put forward and expand on 13 these approaches as we move to the second

14 draft. 15 And when we get to the final 16 Policy Assessment, I think our goal is that we 17 will have an approach that builds on what 18 we've learned doing the fine particle review. 19 For those of you who have been 20 involved in that, we do have consideration of 21 these broader PM distributions, as part of a 22 basis for informing decisions on alternative

### 202-234-4433 Neal R. Gross & Co., Inc. Page 41 1 standards. 2 And so building on what we've 3 learned for PM, we are planning to, well, our 4 plan is to try to build on what we've learned

5 for the ozone assessment. 6 Now we have a couple of issues 7 that I'll just raise here really quickly, that 8 complicate the way in which we consider air 9 quality and these distributions and study 10 locations. 11 And the first one is, how do we 12 interpret confidence intervals? So, given 13 that as we go down to lower and lower ozone 14 concentrations, and we have characterizations 15 of associations at lower and lower ozone 16 concentrations, the confidence intervals get 17 wider and wider. 18 And that's not necessarily 19 reflective of a lack of an association down at 20 lower concentrations so much as decreasing 21 data density. And so, how should we think 22 about those confidence intervals as you get

### 202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 down to lower and lower ozone concentrations? 2 The second issue that I'll raise 3 is really related to the fact that we are 4 dealing with studies that often average across 5 monitors. 6 And yet, we are thinking of those 7 studies within the context of a standard that 8 is based on concentrations measured at the 9 highest ozone monitor. 10 And so, you know, we have to think 11 about the relationships between those average 12 ozone concentrations and the studies and the 13 concentrations that are more relevant for 14 comparison to the standard. 15 And so, you know, and this is an 16 issue that we're grappling with. We, 17 obviously, grappled with it in the first 18 draft, and we'd be looking for any feedback on 19 that issue as we move forward into the second

20 draft. 21 And then finally, I'll just note 22 that for some studies we don't have all of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 data available that we would like, and that 2 necessitates use of surrogates for things like 3 study areas, in some case, or air quality 4 metrics. And so that can introduce some 5 uncertainties into these comparisons. 6 So as we move forward into the 7 second draft, I think I've already implied 8 that we're going to be looking to refine and 9 potentially expand the approach that we have 10 laid out in the first draft for considering 11 distributions of ozone air quality. 12 And then on a slightly different 13 note, we'll also be looking at protection 14 provided. Even though we're talking about 15 short-term standards in this first draft, 16 we'll be looking at the extent to which those 17 short-term standards can provide protection 18 against exposures to long-term concentrations. 19 And so that was a rather quick 20 overview of Chapter 4. I'm going to now turn 21 it over to Vicki, and she's going to talk 22 through the welfare chapters.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 44 1 MS. SANDIFORD: Thank you, Scott. 2 As was done in the human health effects side 3 of the Policy Assessment, we also focused on 4 the weight of evidence conclusions developed 5 by North Carolina and the ISA. 6 Primarily focusing on those 7 vegetation and ecosystem level effects for 8 which there was found a causal or likely to be 9 a causal relationship. 10 The vegetation effects published 11 since the 2006 Criteria document supports, 12 strengthens, and is consistent with key 13 conclusions drawn from previous reviews 14 regarding visible foliar injury, growth, 15 productivity, and carbon storage. 16 This new evidence also increases 17 the coherence in the weight of evidence based 18 on new mechanistic studies in the areas of 19 genomics and proteomics. 20 And it reinforces previous 21 conclusions regarding the importance of 22 cumulative seasonal peak weighted exposures

### 202-234-4433 Neal R. Gross & Co., Inc. Page 45 1 and selecting biologically relevant exposure 2 indices. 3 The vegetation effects evidence is 4 also useful for assessing the adequacy and 5 appropriateness of the current standard, and 6 for considering potential alternative 7 standards to be assessed in the second draft

8 REA. 9 It includes information that helps 10 us determine what the appropriate forms, 11 levels and averaging times would be for

12 further assessment. 13 In considering the public welfare 14 implications of the evidence, staff determined 15 that the adversity paradigm described in the 16 last review was still appropriate, with the 17 addition in this review of impacts on 18 ecosystem services. 19 We did look at impacts on other 20 welfare effects, such as climate and UDB. 21 However, the information was determined to be 22 insufficient to inform judgments regarding the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 adequacy of the current standard at this time, 2 although some of these effects are described 3 qualitatively. 4 The primary focus of Chapter 6 is 5 on the assessments that were conducted in the 6 Welfare Risk and Exposure Assessment, and 7 include preliminary estimates of national 8 scale ozone exposures and vegetation risk in 9 terms of relative biomass loss that remain 10 after simulating just meeting the current 11 secondary NAAQS.

12 In the second draft REA -- second 13 draft Policy Assessment, excuse me, we will

14 look at assessment of other effects that have 15 been discussed here in this meeting, as well 16 as additional analyses on visible foliar 17 injury and crop yield loss, and taken into 18 account, excuse me, recommendations from this 19 Committee. 20 The second draft Policy Assessment 21 will also consider the preliminary results of 22 analyses that have been made available in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 47 1 terms of the FASOM model and i-Tree models, as 2 well as information that will be added on the 3 forest health monitoring and FIA Data. 4 Chapter 7 is also our chapter to 5 focus on preliminary conclusions regarding the 6 adequacy of the current standard and 7 additional analyses that should be done in the

8 second draft. 9 Regarding the range of alternative 10 standards that would be appropriate for 11 consideration, the first draft Policy 12 Assessment presents our conclusions in regard 13 to form, averaging time and level. 14 And this chapter concludes that 15 it's appropriate to continue focusing on the 16 Cumulative Peak Weighted Exposure Index W126 17 to continue looking at the 12-hour daytime 18 diurnal exposure period, maximum consecutive 19 three months seasonal exposure period, and 20 three year average. 21 With regard to level, in the last 22 review and in the 2010 reconsideration, CASAC

### 202-234-4433 Neal R. Gross & Co., Inc. Page 48 1 recommended a range of seven to 15 parts per 2 million hours. 3 In this review, we re-evaluated 4 that and came to the preliminary conclusion 5 that the new evidence reinforces support for 6 analyzing levels with that same range, seven

7 to 15. 8 That's it. Thank you, and look 9 forward to your comments. 10 CHAIR SAMET: You're finished? 11 Okay. All right, good. Thank you, and I 12 think just as a comment, Karen, I think your 13 explanation was very helpful. 14 Sort of thumbing back through what 15 was in Chapters 1 and 4, I think much of what 16 you said is not actually reflected in the 17 current language, and I think it would be 18 helpful if it were augmented, particularly 19 some of the earlier case history. 20 I think that would be helpful to 21 the document. Let me ask if other members 22 have questions or concerns.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 49 1 DR. VEDAL: I agree, that whole 2 discussion was very helpful. And Karen's 3 perspective was also helpful and has 4 implications for what we do. 5 I just want to make a couple of 6 points. One is a small one. So the first one 7 is that, you know, this issue of the 8 background not being relevant for the delta, 9 is true, if I understand it, if you're looking 10 at absolute reductions. 11 But proportional or percentage 12 reductions in fact are sensitive to whether 13 you include background or not. 14 The bigger issue has to do with 15 what we do in our deliberations with respect 16 to background. And we had a lot of discussion 17 yesterday about the utility of estimating 18 risk. Not down to zero, but in addition down 19 to some definition of background. 20 And many of us thought there was 21 utility in that and that it would be useful if 22 the Administrator had that information.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 Now, after listening to you, I'm 2 not sure that's the path, I'm not sure, I'm 3 not as confident that that's a path that we 4 should go down. 5 So, I guess I wanted to hear your 6 perspective on that whether we should persist 7 in that, with that recommendation. 8 DR. MARTIN: It's hard to argue 9 that a fuller characterization of air quality 10 and understanding more fully what sources 11 contribute to it, isn't in general useful to 12 understand, at least as a backdrop for 13 understanding the context of the levels that 14 you're looking at. On the other hand, it's 15 also hard to argue, in this particular case, 16 that assessing risk above any one particular 17 definition of background, there's no one right 18 way to do it, obviously.

19 And to what extent does that 20 better inform an understanding of the extent 21 to which the current standard is adequate when 22 their primary focus is on broad measures of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 51 1 national public health? 2 So I don't have a more specific 3 answer to your question, but it depends, in 4 part, upon the purpose for doing it, if it's 5 a general characterization for broad context, 6 that's one thing. 7 If it's intended because for some 8 reason the decision has to hinge on that 9 particular metric of risk, then I fail to see 10 that there's any particular utility to that. 11 DR. VEDAL: I guess we viewed it 12 as it was information that might be useful, 13 couldn't hurt, but not in the sense that she 14 would, you know, that it would be entirely 15 based on that sort of perspective. 16 CHAIR SAMET: Okay, Fred? 17 DR. MILLER: Well, Sverre 18 identified exactly where I've been coming 19 from, and that is, what is the percentage 20 reduction in risk? 21 And I think it is relevant. And 22 I'd like to ask you a couple questions. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 52 1 I totally agree that some of the strength in 2 my written preliminary comments would have 3 changed had the chapters, you know, included 4 the kind of discussion that you've just 5 presented. 6 So, I wanted to ask if the 7 attainability that you mentioned in terms of 8 the 1979 part, and the fact that you're using 9 a single value for background, does that 10 violate or aggregate what's being proposed 11 now, with having more region-specific in the 12 ability of the models to take this into 13 account, that in fact, in your risk analyses, 14 you should still be -- I don't think it does, 15 but I just want to make sure, because you 16 didn't mention any subsequent precedent about 17 whether or not, how that ought to be 18 considered. 19 DR. MARTIN: I can see no earthly 20 reason not to take advantage of all the new 21 work that's been done to develop more 22 sophisticated models to allow us to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 53 1 characterize air quality and background, in 2 particular, in a much more nuanced way. I 3 mean, why wouldn't we use that new 4 information? 5 And even to some extent in the 6 last review that ended in 2008, again, it was 7 risk in excess of background, but even there, 8 it wasn't just a constant level of background, 9 but there was some encompassing of the new

10 model value -- 11 DR. MILLER: Okay. All right. And

12 then -- 13 DR. MARTIN: So how we approach it 14 as an analytic matter has changed as new tools 15 and data become available to us. 16 DR. MILLER: Okay. And then in 17 your discussion about the 1997 and this aspect 18 of no threshold, the game is changed relative 19 to FEV1 changes. 20 The McDonnell paper absolutely 21 shows it's only one chance in more than 36,000 22 that there is not a threshold for FEV1

### 202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 changes. 2 So your comment relative to 3 attainability, I think, becomes extremely 4 relevant to that particular risk analysis for 5 that end point. 6 And the other thing is, the 7 epidemiology studies have examined models that 8 have a threshold, don't have a threshold, and 9 it's kind of like the mega mouse experiment 10 where, for the kinds of things that we're 11 involved, you can't say, you can't prove it 12 one way or the other. 13 And so that's why I keep coming 14 back to having additional information on the 15 percent. I totally endorse the strategy you're 16 talking about, the zero risk scenario, and 17 then your alternative standards, how much does 18 it take you. 19 But, in judging between, having 20 the information that the Administrator may 21 need to judge what's the delta in that 22 interval that they can sustain, that's where

### 202-234-4433 Neal R. Gross & Co., Inc. Page 55 1 the percent reduction in risk comes into play. 2 And I feel like you're going to be 3 asked for and I don't see why you can argue 4 that more information isn't. But it doesn't 5 change the strategy that you're taking of 6 examining the alternative levels, it's just 7 one more piece on a graph or a table 8 somewhere. So that's why I will come back to 9 the percent reduction. 10 CHAIR SAMET: Okay, to be 11 continued.

12 DR. MILLER: Yes.

13 CHAIR SAMET: Ana. 14 DR. DIEZ-ROUX: Yes. I think 15 those comments were also very helpful. I just 16 wanted to make a few comments, to make sure 17 that I'm understanding exactly what is being 18 done in the REA. 19 So, as I said yesterday, and I 20 agree with what Karen was saying, I think it 21 makes total sense when estimating the total 22 deaths attributable to ozone, to use all the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 56 1 information we have, and extrapolate that to 2 wherever we feel is reasonable, and therefore 3 not use the background as the lower level, if 4 we have evidence that suggests that the dose 5 response curve goes below that. 6 And, of course, there may be some 7 uncertainty about that, and that's true. So 8 that's one point. The second point in this, 9 hypothetically, one might want to estimate the 10 maximum potential benefit of reducing a 11 standard, ignoring the background as well. 12 What's the maximum potential benefit? 13 However, as I understand it, in 14 the current risk reduction estimates that you 15 have in the REA, you know, where you're 16 estimating both the absolute and percent 17 reduction in risk associated with just meeting 18 the standard, or in the future with 19 alternative standards, you are taking 20 background into account. 21 Because you are, as I understand 22 it, you're setting, you're using background as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 57 1 the lower bound. So in a sense, the 2 calculations that we have in the document 3 right now are achievable, assuming that 4 reductions below a given background are not 5 possible. 6 I just want to make sure that 7 that's correct, that interpretation is 8 correct. Because that's what you have in the 9 REA right now. 10 And as I understand it, that's 11 what you're proposing to do with the other 12 standards as well. So it is achievable 13 benefit, assuming reductions below background 14 are not possible, is that correct? 15 DR. MARTIN: Right. Because the 16 emission changes that go into simulating just 17 meeting -- 18 DR. DIEZ-ROUX: That's right. 19 DR. MARTIN: -- the alternative 20 standards are only changing anthropogenic -- 21 DR. DIEZ-ROUX: That's right. 22 DR. MARTIN: -- U. S. emissions.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 DR. DIEZ-ROUX: That's correct.

2 DR. MARTIN: As far as that takes 3 them, yes. 4 DR. DIEZ-ROUX: So background is 5 taken into consideration in that portion of 6 the analysis. So I think we have, you know, 7 addressed, you know, we are addressing some of 8 the concerns that people have. 9 DR. MARTIN: It's not truncating 10 some overall estimate of risk at a background

11 level. 12 DR. DIEZ-ROUX: Right. 13 DR. MARTIN: But it does, as Bryan 14 alluded to, take into account -- 15 DR. DIEZ-ROUX: That's right. 16 It's geographically varying and --

17 DR. MARTIN: Yes. 18 DR. DIEZ-ROUX: Now, what that 19 raises, also, is what is it that is being used 20 for the background, right? Because you're 21 going to get different results, depending, we 22 have all these backgrounds, on which

### 202-234-4433 Neal R. Gross & Co., Inc. Page 59 1 background and which model. 2 So that introduces a whole range 3 of uncertainties in that domain, as well, 4 which it may be important to say something

5 about.

6 CHAIR SAMET: In terms of 7 presentation, I mean, I think, if you had the 8 right pictures to show this. I mean, if you 9 had a circle that comprised total ozone risk, 10 i.e., down to zero. 11 And then you began to fractionate 12 that into that attributable to not meeting the 13 current standard, to meeting a potential 14 alternative standards. The difference between 15 actual and background. Whatever it is, I 16 think something like that would be helpful. 17 Because, you know, I think part of the 18 confusion here is simply one of terminology. 19 And just sort of getting all this 20 straight in a way that when everybody talks 21 about this, you know, we're all talking about 22 the same thing.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 60 1 And I think some of our confusion 2 over the last day has simply reflected the 3 complexities of the terminology And as Ana, 4 I think, just made very clear, what the models 5 are doing in the case of background, and how 6 the analysis, how the modeling truncates at 7 the background. 8 So I think those, if you could 9 capture that in a way that everybody could see 10 it, I think it would be extremely helpful.

11 There's both the level of the 12 concentrations and the associated burden of 13 risks that are important to show. Fred.

14 DR. MILLER: Ana asked the 15 question in the right way, and I appreciate 16 it. Because I think that clarifies. However, 17 the way the current material is written, it 18 implies that you just stopped your 19 calculations for the alternative when they

20 were below the LML. 21 And the LMLs are four to five 22 times lower than the U.S. background, the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 61 1 North American -- whatever background you want 2 to put in. 3 And so I got the impression that 4 you were not terminating it at whatever was 5 the background level in that region, in terms 6 of that, because it's clearly -- you said that 7 you, in the presentations earlier about the -- 8 you truncated it only when it dropped below

9 the LML. 10 So if you're doing what Ana asked, 11 and you just implied now, changes 12 tremendously. And I agree, that incorporates 13 what we're, what I'm trying to get at in this 14 percent risk. So I'm confused to how that

15 came across. 16 DR. MARTIN: One observation I 17 would make about the comparison between LML, 18 the lowest measured level in a given study 19 that we're drawing a response function from, 20 and background. 21 The background estimates that are 22 generally presented are longer term average

### 202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 estimates. They're median values of the whole 2 distribution of background values that occur, 3 that change hour by hour, day to day 4 throughout the year. 5 So the low end of those background 6 estimates are very low, relative to those 7 median values. So the question about: how can

8 a lowest measured level be lower than 9 background? 10 Well, if you're focused on the 11 median background you're not taking into

12 account the whole lower half of the 13 distribution of background values. 14 So the lowest measured level in 15 any given study on the lowest day will clearly 16 be well below that median value of background. 17 So that would explain why there's such a 18 difference there. 19 DR. HUBBELL: I need to clarify 20 that, because I think there's still a 21 fundamental misunderstanding, to make sure we 22 get this straight.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 63 1 What Ana was referring to and what 2 you're referring to are different aspects of 3 the analysis. When we do the absolute risk 4 calculations, the total risk associated with 5 a given concentration of ozone, we are going 6 all the way back to the LML or down to zero. 7 What Ana's referring to is: when 8 we are simulating just attaining the 9 standards, when we're moving the air quality 10 distribution down to just attain the 11 standards, the amount that we move the air 12 quality distribution down is limited by U.S. 13 background.

14 So we don't allow for there to be 15 changes in the air quality distribution beyond 16 what would be accomplished by reducing U.S. 17 emissions. 18 But we're still calculating the 19 total risk, all the way down to zero or to the 20 LML. So your concern that you keep raising 21 about what's the percent comparison point, 22 that has not changed from what we talked about

### 202-234-4433 Neal R. Gross & Co., Inc. Page 64 1 yesterday. All right? 2 So you're still taking the percent 3 of total risk. And so, when you look at the 4 reduction in risk that's occurring between 5 current conditions and just meeting the 6 existing standard. 7 What you're seeing is a percent 8 reduction relative to total risk down to zero. 9 Not a percent of total risk down to background

10 levels. 11 CHAIR SAMET: So, Bryan, just one 12 point of clarification. So the background, 13 U.S. Background is where you truncate? 14 DR. HUBBELL: In this particular 15 case, yes. 16 CHAIR SAMET: So I think, 17 actually, I think we don't want to belabor 18 this. I think the point probably is that if

19 we're confused -- 20 DR. HUBBELL: Yes, I'm agreeing, 21 we've got to do a better job of laying those 22 out, but --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 65 1 CHAIR SAMET: Yes, this just has 2 to be better explained. I mean, that's -- 3 DR. HUBBELL: Yes, absolutely. 4 CHAIR SAMET: -- probably the 5 bottom line here. 6 DR. HUBBELL: Yes. And I agree, a 7 diagram would probably be most helpful in 8 laying out the different components and the 9 different aspects of the analysis, both in 10 calculating absolute risk and then in 11 calculating the reductions in risk. 12 And I think we just need to 13 clarify that. But I just don't want there to 14 be confusion there. 15 DR. DIEZ-ROUX: You now, a good 16 place where this could go is in that framework 17 chapter --

18 DR. HUBBELL: Yes. 19 DR. DIEZ-ROUX: --in the REA.

20 DR. HUBBELL: Yes. 21 DR. DIEZ-ROUX: That's exactly 22 where this should go.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 DR. HUBBELL: No, I've made a very 2 large note saying that we will do that. It 3 looks Chris has got a figure for us. 4 DR. CHOCK: Another issue is the 5 definition of PRB, this adds more confusion to 6 the issues --

7 DR. DIEZ-ROUX: Yes. 8 DR. CHOCK: -- so maybe you have

9 the -- 10 DR. HUBBELL: Yes. And again, 11 also to be perfectly clear, while I'm up here, 12 is that while we looked at U.S. Background on 13 this initial calculation of just meeting the 14 current standard, it does not mean that we 15 would limit ourselves to just looking at U.S. 16 Background as one potential definition we 17 would use than looking at alternative 18 standards that might require us to go lower. 19 CHAIR SAMET: Okay. Let me ask, 20 if there are any other questions, because we 21 probably need to move on. Particularly, since 22 some of you want to truncate this meeting as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 67 1 background. Anything else? 2 DR. BRIAN: I would just echo what 3 you said at the outset. Karen, your 4 commentary was extremely helpful, and the only 5 request is, you know, to have the same clarity 6 in the document. 7 CHAIR SAMET: Okay. Great. Thank 8 you. And so, we'll move on to the public 9 comment period. And we have two public 10 commenters, George Wolff, by phone on behalf 11 AIR Improvement Resources. Let's see, George, 12 are you on? 13 DR. JACOB: -- can hear me, but I 14 don't think they can hear us.

15 CHAIR SAMET: Yes.

16 DR. JACOB: Yes. 17 MR. HEUSS: This is Jon Heuss. 18 I'm also on, and hopefully, they'll open up a 19 mic or something and then hear me. Then they 20 can hear you folks too. 21 CHAIR SAMET: So do you want to 22 comment, Ana?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 68 1 DR. NUGENT: Hello, this is Angela 2 Nugent, the DFO. I ask everybody on the 3 phone, except the public speakers, who are 4 speaking right now, to put their phones on

5 mute. 6 And the public speakers to use a 7 land line, or, and a headset not a speaker 8 phone, please. That makes a big different for 9 audibility. 10 DR. SUH: Actually, Angela, this 11 is Helen. Daniel's been trying to have a 12 comment, and somehow it's been tough to hear

13 us. 14 CHAIR SAMET: No, we haven't heard 15 you at all. So, actually, if, Daniel, if you 16 want to go ahead and make a comment or 17 something, please, go ahead, before we move on 18 to something -- 19 DR. JACOB: Yes, and so in the 20 interest of it will be really brief, can you

21 hear me now? 22 CHAIR SAMET: We really can.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 69 1 DR. JACOB: Okay. So my first 2 comment was, with regard to the consideration 3 of a U.S. Background, of a North American 4 Background, and is, whether that would 5 actually very severely limit you in order, in 6 the expiration of lower standards. 7 For example, you know, if you go 8 to border areas, the U.S. Background can be 9 really high. And so you may not be able to 10 achieve 70 ppb standard, or 65 ppb standard 11 until you had time to get to the 65 or 60 ppb 12 standard, you may not be able to achieve that 13 in that in locations in the inter-mountain

14 west. 15 So at that point, you are not 16 really able to quantify your risk reduction 17 associated with the particular standard, 18 because you cannot meet that standard in parts 19 of a country. 20 And I'm sure you've thought about 21 this, but I wanted to have your thoughts on 22 this. The second question I had was with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 regard to the implementation, and it's a 2 little bit connected to that, is that, I 3 understand that the background may not be 4 relevant in terms of quantifying risk 5 reduction, but it's highly relevant in terms 6 of the implementation of the standard. 7 And so the kind of emission 8 reductions that one might have to seek in 9 order to meet the standard, and I was 10 wondering whether that's relevant to the 11 Policy Assessment? Not just setting the 12 standard, but how would you go about meeting 13 it? 14 CHAIR SAMET: Let's see, where's 15 Lydia, or Karen, or, Karen's coming.

16 DR. MARTIN: To address the 17 question of, is it relevant? It's obviously 18 relevant in the broad sense, because setting 19 standards necessarily leads to the 20 implementation of standards, which was one of 21 the reasons why we engaged in this in the 22 context of the Policy Assessment.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 71 1 But it is clearly not the role of 2 the Policy Assessment to take on a discussion 3 of implementation issues, because those issues 4 aren't relevant to setting the standard. 5 But clearly, the Agency will 6 engage in those issues as a separate, but very7 related matter, as we proceed to the rule8 making in this review. 9 CHAIR SAMET: Okay. And I think 10 your first question we'll take as a comment, 11 and leave that. Helen, actually, I'm sorry, 12 we ignored you too, do you have anything you

13 want to add? 14 MS. SUH: Well, not at this time, 15 but thank you. 16 CHAIR SAMET: Okay. All right, 17 good. Then we'll move on to the public 18 comment period. Let's see, George, are you

19 on? 20 MR. HEUSS: This is Jon Heuss. 21 I'm going to be speaking for George. He's not 22 available this morning.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 72 1 CHAIR SAMET: Okay, Jon, then go

2 ahead. 3 MR. HEUSS: Thank you. We at AIR 4 really have three major comments. The first 5 one, obviously, has to do with background. 6 And would point out that yours being not NAB 7 is more appropriate for background for most of 8 the U.S., and these comments that the AIR made 9 on the first couple drafts of the ISA.

10 The other comments we made at that 11 point were that the analysis of USB on days of 12 high end of ozone were needed and the impact 13 of USB on observed concentrations rather than 14 USB itself should be considered because of the 15 non-linearities in the ozone formation 16 process. 17 We emphasize that EPA can't 18 eliminate or even reduce emissions in Canada 19 or Mexico, and that the use of NAB instead of 20 USB would penalize the states effected by the 21 Canadian-Mexican emissions. 22 And that the use of NAB instead of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 73 1 USB would overestimate the risk reduction 2 achieved by lowering the NAAQS. Third Draft 3 ISA was much improved. 4 It endorsed the use of USB, 5 included the most recent GEOS-Chem and CAMx 6 results, included a discussion of days in the 7 high end of ozone distribution, recognized the 8 important distinction between background and 9 contributions to background, and acknowledged 10 that further work is needed to help determine 11 the contributions of background sources to 12 urban concentrations. 13 However, when we started looking 14 at the PA, the first draft, there's a 15 disconnect between the Third Draft ISA and the 16 First Draft PA. 17 The PA only mentions USB in 18 passing. All the analyses shown or done there 19 use NAB not USB. And no attempt to estimate 20 the background impact on urban ozone 21 concentrations has been made yet. 22 So the PA, will not reflect the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 state of our knowledge on background ozone or 2 below the risk until these elements are 3 included.

4 Second comment we have relates to 5 the way the consistency of epi associations is 6 stated in the draft. We find many places 7 where the consistency is overstated. 8 I'll give you one example, and 9 it's an important one. EPA talks about 10 consistent positive associations for 11 respiratory mortality in the APHENA study. 12 However, the HEI Review Committee 13 said in all year analyses associations between 14 ozone and respiratory mortality generally 15 close to zero, and not significant in any of 16 the regions or in the combined estimate for 17 all three regions. 18 The APHENA investigators also said 19 they found little evidence for effective ozone 20 on respiratory mortality in any center. This 21 is a huge study, as you know. 22 Now while the associations were

### 202-234-4433 Neal R. Gross & Co., Inc. Page 75 1 generally higher in the summer-only analyses, 2 only two of the 12 model combinations they 3 evaluated were statistically significant. 4 And when they control for PM10 5 none of the eight model combinations that are 6 presented in the APHENA Report were 7 statistically significant. 8 We'll provide other examples of 9 the way the PA overstates consistency in our 10 written comments. The third major area is the 11 fact that dose plausibility for the more 12 severe effects is not rigorously evaluated and 13 discussed in the PA. It should be. 14 From the control studies, clearly 15 a threshold for the first physiological 16 effects, whether it's FEV1 symptoms, 17 inflammatory markers. 18 And we also know that exercise is 19 very important in terms of how low the 20 concentrations are when these are first 21 perceived. 22 We also know that personal

### 202-234-4433 Neal R. Gross & Co., Inc. Page 76 1 exposures are very, very below ambient levels 2 90 percent of the time when people are 3 indoors. 4 And all these factors raise 5 questions about the very low concentrations 6 that are implied is causing premature 7 mortality. 8 And if we look at the epi, then we 9 see several studies now that measurement error 10 can give a false linear result. And then we 11 look at the pattern in the individual city 12 associations, it's biologically impossible. 13 When Bell, et al. (2007) 14 restricted -- that asked the says with ozone 15 less than 0.02 ppm, the range in individual 16 city and mortality associations for a ten part 17 per billion increase was widened. It went 18 from minus 20 percent to plus 30 percent. 19 DR. NUGENT: Mr. Heuss, you have 20 one minute. 21 MR. HEUSS: Thank you. Well, with 22 this wide range of individual city

### 202-234-4433 Neal R. Gross & Co., Inc. Page 77 1 associations, it calls into question, how you 2 can combine these two to understand that there 3 might be a small effect or not. 4 And we would hope that the PA 5 would rigorously evaluate dose plausibility, 6 and consider that as we move forward. Thank 7 you, much. 8 CHAIR SAMET: Okay. Thank you. 9 Any questions or comments? 10 (No response.) 11 CHAIR SAMET: Okay. Thank you. 12 We'll move on to our second public speaker, 13 Roger McClellan. Roger. 14 DR. McCLELLAN: Good morning. 15 It's a pleasure to again address the CASAC 16 Panel. I appreciate the importance of your 17 public service and hard work. 18 I understand the commitment having 19 personally served as Chair of CASAC and on 20 numerous CASAC panels. The challenges you 21 face today are very substantial, as a result 22 of the major improvements in air quality that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 have been achieved over the last four decades 2 and the increasing narrow margin between the 3 standards in ambient background ozone. 4 In the brief time I have available 5 today, I want to make several points. First, 6 it's important to recognize your central role 7 in reviewing the adequacy of the current ozone 8 NAAQS as assuring the quality of the science 9 and scientific judgments that will inform 10 policy judgments, that are the exclusive 11 responsibility of the EPA Administrator. 12 The current process is an exercise 13 in using ever changing science to inform 14 policy judgments on the four elements of each 15 NAAQS, the indicator, averaging time, level, 16 and statistical form. 17 Despite efforts by many 18 individuals to streamline the process, the 19 process has become more complex and

20 cumbersome. 21 In my opinion, the process is 22 clearly flawed. Even the most ardent follower

### 202-234-4433 Neal R. Gross & Co., Inc. Page 79 1 of the process is challenged to keep track of 2 the changing landscape of what has been 3 assembled and interpreted. 4 I submit, that one of the 5 difficulties with the current process, is that 6 it is inappropriately expecting the science to 7 provide public policy decisions. 8 Scientific knowledge can and must 9 inform public policy decisions. However, it 10 is not possible for science to establish what 11 is an acceptable or unacceptable public health 12 or welfare risk. 13 Without clear evidence for an 14 absence of harm, every decision as to a level 15 and form of the NAAQS is a policy decision as 16 to an acceptable level of risk. 17 In my opinion, the current ozone 18 NAAQS process being driving by a view, that if 19 enough effort is expended a wall of ozone 20 science will be created that is so solid and 21 consistent the level informed in the NAAQS 22 will be clear to any observer of the law.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 80 1 This is a misguided view of the 2 role of science in informing public policy 3 decisions. In my opinion, the EPA staff and 4 CASAC are not neutral, impartial participants 5 in the review process. 6 Each individual brings to the 7 process their professional expertise, their 8 personal ideologies and, in some cases, even 9 preferences for a final rule. I ask you to 10 set aside your personal preferences and focus 11 on the science. 12 It's apparent that the policy 13 judgments involved in the review and setting 14 of NAAQS have been heavily influenced by the 15 results of a few published studies. 16 The importance of these studies is 17 exemplified by EPA obtaining from the 18 investigators information that did not appear 19 in the original publications or supplement. 20 All such requests and data should be contained 21 in the Ozone Docket and preferably be

22 traceable to the ISA.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 81 1 Moreover, I urge, that if the 2 results of any particular study are to be used 3 to inform public policy judgments, the 4 original data under-girding those publications 5 and releases should be made available to all 6 qualified scientists. 7 In my opinion, the present draft 8 policy assessment is largely a place holder. 9 The document contains a Section 4.3 additional 10 analyses to inform second draft policy

11 assessment. 12 In my opinion, the additional 13 analyses are an attempt to giving an answer 14 that may and is indeed beyond the role of 15 science. The specific level -- 16 DR. NUGENT: Excuse me, Dr. 17 McClellan, one minute. 18 DR. McCLELLAN: -- inform of the 19 revised NAAQS. It's my view, that in this 20 particular review, current background ozone 21 levels are playing a key role. 22 We have much better information.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 That information deserves to be clearly laid 2 out and analyzed and interpreted. In 3 conclusion, it is well-recognized that science 4 must be used to inform the judgments that the 5 Administrator must make. 6 However, it's important to 7 recognize that the science alone cannot 8 identify the specific level and form of the 9 Ozone NAAQS. 10 Determining how low is low enough 11 involves identifying an acceptable risk target 12 level and form, and I emphasize the importance 13 of the statistical form. These are policy 14 judgments that must be made by the EPA 15 Administrator. 16 It is important that the Policy 17 Assessment document clearly layout the 18 guidelines as to how the science is going to 19 be used to inform those policy judgments. 20 Thank you for your attention. 21 CHAIR SAMET: Okay. Thank you. 22 Comments, questions? To those on the phone,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 83 1 Helen, Daniel?

2 DR. SUH: No.

3 DR. JACOB: No. 4 CHAIR SAMET: No. David? 5 DR. GRANTZ: Does this imply that 6 a series of well-reasoned qualitative risk 7 assessments would be either preferable or 8 sufficient in this process? 9 DR. McCLELLAN: They certainly 10 would have a role. And I'm not arguing that 11 quantitative assessments do not have a role. 12 In fact, I think I was probably one of the 13 earliest advocates of quantitative risk 14 assessments informing these judgments. 15 What I'm concerned about is the 16 fact we've moved to a process where we keep, 17 by analogy, grinding the flower finer and 18 finer. As my wife once told me, the finer the 19 flower gets the less useful it is for baking. 20 I think we have a similar situation here 21 today. 22 CHAIR SAMET: Okay. Anyone else?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 84 1 Okay. Thank you, Roger. So I think what 2 we'll do is get started and perhaps take a 3 break. Some of you may need to check out. 4 So why don't we get started with 5 Chapter 1 of the Policy Assessment. So let's 6 see, we have Daniel, George, and David. Let's 7 see, Daniel, do you want to go ahead with 8 comments on Chapter 1? 9 DR. JACOB: Yes, sure. Can you

10 hear me? 11 CHAIR SAMET: Yes, yes. 12 DR. JACOB: Okay. So, you know, 13 Chapter 1 is a good start, but it's got some 14 weaknesses that I think should be corrected. 15 And there's a number of technical points in my 16 preliminary comment. I'm not going to go over 17 this. 18 The one sentimental point, and 19 this is again sounding like a broken record, 20 is about the description of the ozone 21 background. But this is really important, of 22 course, in this Chapter of the PA, to convey

### 202-234-4433 Neal R. Gross & Co., Inc. Page 85 1 to the reader a good understanding of what 2 does background really represent. 3 And right now, I think that this 4 draft fails to do so. It fails to convey a 5 very important point, which is, that this 6 background doesn't really represent high 7 events associated with stratospheric 8 intrusions, intercontinental transport, or 9 fires. 10 No, that background is really a 11 uniform, fairly invariant, moderately high 12 level of ozone that you get in places like the 13 inter-mountain west. 14 And that uniform background cannot 15 be easily tied to a specific source. It 16 reflects, as I point out in previous comment, 17 just a general behavior of ozone in the 18 troposphere that ozone increases with 19 altitude. 20 And the PA, right now, it kind of 21 conveys that maybe we should be able to 22 recognize background events in the same way

### 202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 that we had recognized exceptional events. 2 Well, no, we really can't. And 3 this is, I think, the big challenge in 4 accounting for the background in this

5 assessment. 6 Anyway, there's other points 7 that's, well, okay, another point that I 8 wanted to make that should be really in the 9 PA, is that when it comes to occurrences of 10 high background, and those do happen, so we 11 have this moderate background, you know, that 12 increases with altitude, so background is 13 pretty low at sea levels and it's relatively 14 high at elevated sites. 15 And then, on top of that, yes, we 16 do have occasional events of elevated 17 background. And I think an important point is 18 that the models failed to reproduce them. 19 And they fail for reasons that are 20 very much intrinsic to the transport structure 21 in the models, and that are not easily 22 addressed by simply increasing resolution, or

### 202-234-4433 Neal R. Gross & Co., Inc. Page 87 1 anything. 2 It really has to do with the fact 3 that the transport say of plumes or of 4 stratospheric layers is very filamented. And 5 this filamented structure is not something 6 that you can probably describe in models that 7 intrinsically do a significant amount of 8 spatial averaging. 9 Finally, I think that the chapter 10 spends too much space on ozone production from 11 fires. And it conveys a notion that fires are 12 a really big deal in terms of the ozone 13 background, in terms of occurrences 14 availability to background. 15 I would say that this is mainly a 16 model result, and like the hot spots over 17 central Idaho is a model result. And, in 18 fact, in the observations you don't see this. 19 And the times where you see 20 elevated ozone associated with fire plumes, it 21 seems to be when those fire plumes are mixed 22 with urban influence.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 88 1 There's a lot of uncertainty over 2 this, and clearly, you know, we don't yet have 3 a firm knowledge of the contribution of fires

4 to ozone. 5 But we have pretty clear idea that6 models like CMAQ and also GEOS-Chem, over7 estimate the amounts of ozone that's generated 8 by wild fires. 9 And there's some papers in the 10 literature to that effect. And I think that 11 they should be cited, and I give references in 12 my comments, in the PA. 13 Right now, the impression one gets 14 from the PA, that the fires make a lot ozone, 15 and I think that should be taken with a grain 16 of salt. That's it. 17 CHAIR SAMET: Okay. Thank you. 18 George? 19 MR. ALLEN: All right. I have 20 some good news for you. I'm not going to 21 mention background ozone. I think Daniel 22 covered that one sufficiently.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 89 1 Chapter 1 is really an overview. 2 It starts out with a pretty detailed overview 3 of the history of the NAAQS and the process of 4 the ozone NAAQS, which I think is very useful. 5 Section 1.2.3, Page 1-7 covers the 6 reconsideration of the '08 Reg. A fascinating 7 chapter in the ozone NAAQS history. 8 It stops short though, in pointing 9 readers to the 2011 Rule that wasn't, which 10 actually is posted on the EPA website, 11 EPA.gov/G-L-0, for ground level ozone. 12 And under there you just click 13 under regulatory actions and there's the 14 entire rule that was sent to OMB, EPA's final 15 take on it, as well as the regulatory, all the

16 other related documents. 17 And it's interesting reading to 18 see where EPA was at in Summer of 2011, just 19 in some piece of the final chapter of that 20 story. I don't know if it needs to be in 21 there, but it's certainly a piece of the final 22 chapter of that story.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 Other comments, the chapter really 2 is, it's just a brief summary of the Ambient 3 Monitoring Network. It's four pages. It's 4 pretty much overview of what's in Chapter 3 of 5 the ISA, and that's fine. 6 It has appropriate references. 7 There is a concise description of the ozone 8 chemistry again, with appropriate references 9 to Chapter 3. 10 And then the rest of it really is 11 the Ozone Background Summary, which I said I 12 wouldn't mention, so I wont. I'm done. 13 CHAIR SAMET: Thanks. David? 14 DR. CHOCK: I only have two 15 points. First, I think the chapter was very 16 succinct, very well written. The title 17 Background, primarily accounts for historical 18 background. 19 I certainly hope that the 20 description by Karen could be incorporated in 21 this section, expand it, so that we can 22 understand the evolution of thoughts on the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 91 1 approach by EPA. 2 The second point is that I feel 3 that we have been emphasizing the health 4 aspect, but not very much on the welfare 5 aspect. So maybe you ought to expand more to 6 this W126 et cetera, in the write up as well. 7 That's basically it. 8 CHAIR SAMET: Okay. Thank you. 9 And I notice that so far you've escaped. 10 Would you be the summarizer for the comments 11 on this one? 12 DR. CHOCK: Okay. 13 CHAIR SAMET: Thank you. Let's 14 see, and then I think there was, here I think 15 we all probably feel is where you need to very 16 clearly layout what we were talking about 17 before, where we are, background zero North 18 American, you know, the whole bit. 19 Perhaps Chris is going to solve 20 this with a figure, but certainly, that figure 21 ought to have its origins going back to the 22 ISA and the descriptions of ozone production,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 92 1 generation, air, natural background, and so

2 on. 3 Let's see, who else would like to, 4 other comments on Chapter 1? 5 DR. WEATHERS: I just want to 6 underscore what David said. I think this is 7 an appropriate place to lay out the difference 8 between the W126 and the primary standard, and 9 to make clear some of the differences in 10 justifications for consideration of a standard 11 that has to do with exposure. 12 CHAIR SAMET: Okay. Anyone else? 13 Let's try Chapter 2 then, before break. 14 Michelle. 15 DR. BELL: All right, so I don't 16 have a whole lot of comments. I thought this 17 was a very good summary. I also really liked 18 how it focused on being an extension of the 19 2006 document, rather than kind of repeating 20 everything. 21 As is the case with many early 22 drafts, some of the text was a bit unclear.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 93 1 And I'll put some more specifics in the

2 comments. 3 Just a couple of examples, it 4 talks about a focus on policy relevant 5 studies. It doesn't talk about what that 6 means, and how those receive special 7 attention.

8 And then there's some other 9 specific information in there. We were asked 10 to think about the level of detail. I thought 11 overall, the level of detail was okay. 12 There were a few places where I 13 thought it would be useful to have some 14 additional information and more clarification, 15 like text on the limitations, even though 16 there was a really nice start talking about 17 limitations. 18 And I put some specifics in my 19 comments, but I won't go over now, but in 20 general, I thought the information on 21 confounding could be better. I thought the 22 language was not strong enough in thinking

### 202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 about confounding. 2 Information on adaptation and3 averting behavior was not particularly well4 covered. And at the same time, the document 5 seemed almost a little lengthy. Even though 6 I realize I just suggested adding a lot of 7 things. So as a suggestion of ways to kind of 8 make it more concise in other ways, I thought 9 it should really focus on more clearly on key 10 specific points. 11 This document, I thought, could 12 really take advantage of citing other 13 documents and citing other sections as a way 14 to kind of just pull it down and make it more 15 focused. And I also have Joe's comments, Jon, 16 just to let you know. 17 CHAIR SAMET: Okay. Why don't you 18 go ahead and --

19 DR. BELL: You want me to do those

20 now? 21 CHAIR SAMET: Yes, sure. 22 DR. BELL: Okay. So I have read

### 202-234-4433 Neal R. Gross & Co., Inc. Page 95 1 his comments, and what I'm going to talk about 2 here, are just things that are different from 3 my comments.

4 So he had a lot of comments that 5 were very similar to mine, so that's good 6 news, that we're on the same page. He also 7 would like more detail on the definitions of 8 the levels of causality and they need to be 9 agreed upon definitions. 10 He spent a lot of time talking 11 about the issue of adaptation and how that 12 needs to be better dealt with. But he did, 13 also overall, think it was a very nice

14 document. 15 He also wanted it to be crisper 16 and more focused. And said that parts of the 17 document seemed more theoretical and 18 philosophical, rather than actually laying out 19 alternatives and their consequences. 20 And thought it would be useful if 21 in the discussion of evidence that if the 22 choices were more explicit and the positive

### 202-234-4433 Neal R. Gross & Co., Inc. Page 96 1 and negative aspects described, just to be 2 more laid out rather than having it be kind of 3 theoretical. And then the rest of his 4 comments I already covered in my comments. 5 CHAIR SAMET: Okay. Thank you.

6 Sverre. 7 DR. VEDAL: Yes, I mean, 8 obviously, this chapter's entirely, not 9 entirely, very dependent on the ISA. And 10 we've had a lot of discussion about the ISA 11 already and things that we would take some 12 exception with. 13 And things that we would take 14 exception with are necessarily transferred to 15 the policy assessment. And I won't belabor 16 those, but I will itemize some of the things. 17 In terms of the, you know, 18 appropriately reflecting the ISA, I have a 19 paragraph there. It's not very important. In 20 terms of sort of the balance and whether it's 21 technically sound and scientifically sound, 22 again, it's because of reliance, total

### 202-234-4433 Neal R. Gross & Co., Inc. Page 97 1 reliance on the ISA. 2 So the things that I have touched 3 on in my written remarks include new onset 4 asthma and the emphasis that's placed on that. 5 You have a section, again, on 6 respiratory symptoms and medication use and 7 you used descriptors like, clearly 8 demonstrate, and then that's followed by three 9 paragraphs, in which it looks like it's 10 anything but clear. 11 And similarly terms like, 12 consistently associated with, again, in the 13 context of respiratory symptoms and medication 14 use where you have ignored the multi-city 15 studies, which provide the information, that 16 it's anything but consistently associated 17 with. 18 There's reference to PFT responses 19 in asthma and non-asthma. I think some of 20 that is appropriate. It's not appropriate 21 when you reference that to FEV1 changes, where 22 they're really, the evidence and the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 distinction between asthma and non-asthma is, 2 in my opinion, nonexistent. 3 And that also translates to this 4 charge question regarding human exposure 5 studies. I thought, Michelle has addressed 6 the issue about the confounding issue, and 7 embellishing upon that, somewhat making that 8 more substantial.

9 The last comment I have had to do 10 with as you get to the discussion of 11 adversity. I mean, clearly, that's a tough 12 nut. We all have different opinions on 13 adversity, and by necessity, you've had to 14 rely on the American Thoracic Society 15 statements and the updates to that. 16 One specific thing that I was a 17 little puzzled by was that table of grading 18 responses, where these responses are 19 stratified by normal subjects and subjects 20 with disease. 21 And they have, the diseased 22 subjects' table has some rows in it that are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 99 1 unique to disease subjects, and that's 2 appropriate. 3 But everything that's common 4 between the two tables are identical. And that 5 puzzled me. And that is something that is 6 graded as a response of, you know, being minor 7 in a normal subject is also graded the same 8 way in a diseased subject. And on the face of 9 it, that seemed to be, that was puzzling. So 10 that's all I have to say. 11 CHAIR SAMET: Okay. Jack? 12 DR. HARKEMA: I agree with all the 13 comments that have been stated. I guess, I 14 was more on the side that I think the emphasis 15 should be placed more on key studies and the 16 ISA and to really limit the amount of the 17 text. But just to focus really on those key 18 studies and not to reiterate everything in the

19 ISA. 20 One area of discussion that was in 21 the ISA over the past couple of meetings here 22 have been cardiovascular effects, and why the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 100 1 ISA decided not to change the causality on

2 that. 3 And I think that should be 4 captured some how in the document, given the 5 rationale why that, why it is what it is. And 6 there are, I just reiterate what Sverre said 7 about, you have to go back to that ISA now and 8 some things have been included in there that 9 you want to really carefully make sure that 10 that's documented, especially also in relation 11 to the health REA, and the discussion that we 12 had on the threshold model and everything. 13 It's all captured succinctly in the document. 14 But overall, it captured 15 everything pretty well in here. It's just 16 making sure that the key points aren't lost, 17 the key studies aren't lost in there. 18 And I really liked what Susan 19 presented this morning on her slide. And if 20 you follow that format, I think the next draft 21 will be great. 22 CHAIR SAMET: And Jack, you've

### 202-234-4433 Neal R. Gross & Co., Inc. Page 101 1 escaped as well, would you be the summarizer? 2 DR. HARKEMA: No I didn't. 3 CHAIR SAMET: You didn't? 4 DR. HARKEMA: I didn't escape, but 5 I will do it if you want me to. 6 CHAIR SAMET: Thank you. Thank 7 you. Sverre, you escaped, didn't you? Okay. 8 DR. VEDAL: You know, I -- 9 DR. HARKEMA: On the other hand, 10 if he's -- 11 CHAIR SAMET: Thank you, Jack. 12 You know, just on this point about revisiting 13 the cardiovascular, it seems to me that the 14 logic for a decision sits with the ISA, and 15 that you want to stop there. 16 And certainly, we don't want a 17 revisiting of causal determinations in the PA, 18 having done so in the ISA. I guess the 19 question, whether you want to say, you know, 20 here's what we're advancing for consideration 21 in and around health effects, and we're 22 stopping short on cardiovascular because of a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 decision in the ISA. Perhaps, that's how I 2 would have phrased this. 3 But I don't think there's a need 4 to repeat the actual argumentation about why

5 the level of -- 6 DR. HARKEMA: You know, what I 7 meant is that why they came to that 8 determination that clearly. 9 CHAIR SAMET: Okay. All right, 10 let's see, Chris. 11 DR. FREY: You know, I've been 12 thinking a lot about David's comment two days 13 ago, about trying to shorten or consolidate. 14 And, you know, even Dr. McClellan's comments 15 today about, you know, maybe this is getting 16 to be kind of a big, a big process. 17 Do we need Chapter 2 in the Policy 18 Assessment? I mean, if the role of Chapter 2 19 is to say that the ISA reached some 20 conclusions, then that could probably be done 21 in two pages. 22 And if there's some policy

### 202-234-4433 Neal R. Gross & Co., Inc. Page 103 1 relevant interpretation, maybe that's another 2 five or ten pages. But I guess I wonder, why 3 does it need to be 75 pages of material, and 4 how repetitive is it of the ISA? 5 CHAIR SAMET: And we had a little 6 bit of that discussion yesterday, of course,

7 around these documents and the need for them 8 to be self-contained or not. 9 I mean, I think in theory you 10 could say, based on the ISA here's the causal 11 classification, and here's what we view this 12 from the public health perspective and what 13 we're going to emphasize in the policy 14 analyses and have a very brief chapter. 15 On the other hand, you know, if 16 you feel that you need to describe key 17 studies, which was one suggestion. I mean, I 18 think, it's hard to bound what you get into, 19 I guess. 20 DR. FREY: Yes. I think, well, I 21 know from, maybe it was the PM Panel we had a 22 similar discussion. And if I recall, I think,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 104 1 and I'm sure Karen can speak to this better 2 than I remember it, but there may be a reason 3 to write some of this, because this ultimately 4 could help be text for the notice of a 5 proposed rule. And that notice would have to

6 be a stand alone document. 7 So there may be some other benefit 8 to it. But, you know, just from, I guess, all 9 of us who publish papers, if we cite a 10 reference, you know, we don't have to 11 summarize everything about that reference. 12 And, you know, if we agree with 13 it, we can simply say we agree with it, an 14 interested reader can go read it, and it's not 15 necessary to defend it extensively. 16 So, you know, maybe there's 17 another purpose here. But for our purpose as 18 CASAC it just seems kind of redundant to 19 review those. 20 DR. GRANTZ: Well, I'm going to 21 make the same comment about Chapter 5. And I 22 agree. And we were told on day one that it

### 202-234-4433 Neal R. Gross & Co., Inc. Page 105 1 was our role to suggest how these documents go 2 and that it was not required that they be

3 standalone. 4 And I think I would pay some real 5 attention to the comments that Chris has made, 6 because in a sense, there's so much text and 7 so much repetition and obfuscation almost, in 8 these two chapters in particular, that the 9 punchiness of this document, which, I think, 10 it really has to have to be effective, is 11 lost, or is partially lost. 12 It's a very good document. And 13 I'll get to that when I talk about Chapter 5. 14 But I think this important.

15 CHAIR SAMET: Fred? 16 DR. MILLER: I think if the Agency 17 listens to the comments of the primary 18 reviewers it would work. It serves a useful 19 purpose, and I would not eliminate it. 20 And the reason for that is, there 21 are people who are going to only look at this 22 document and just eliminating and requiring

### 202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 them to go to the others. I think if this is 2 more succinct and incorporates the comments, 3 it serves a purpose, and I would not endorse 4 totally eliminating it. 5 DR. SUH: This is Helen. 6 CHAIR SAMET: Helen, go ahead. 7 DR. SUH: Okay. You know, 8 actually, I was thinking about this also in 9 relation to the next chapter that we're going 10 to talk about, Chapter 3. 11 I guess, I think that the summary, 12 a targeted summary could be useful and helpful 13 in providing some background information for 14 the subsequent Chapter 4. 15 But I do think that the summary 16 really has to be targeted to the key questions 17 in Chapter 4. And I saw that that was done in 18 Chapter 2 with the Public Health 19 considerations. 20 But I'm wondering, if perhaps, the 21 summary might be made tighter where some of 22 the key findings and maybe other key

### 202-234-4433 Neal R. Gross & Co., Inc. Page 107 1 associated findings are brought forward from

2 the ISA. 3 And then those, especially the 4 ones that are going to come through again in 5 Chapter 4, but really have that summary be 6 targeted to some of the key policy questions. 7 Now how that gets divided with 8 Chapter, you know, between Chapter 2, 3, and 9 4, you know, it's a little bit tricky. But I 10 do think there is a real possibility of having 11 a much, much more succinct and targeted 12 summary towards the key questions that come 13 out of Chapter 4, about the form and averaging 14 time, and things like that. 15 So I think there is a need for a 16 summary, but I think it could be a lot more 17 crisp. Not crisp so much, but is targeted to 18 the questions at hand in the PA. 19 CHAIR SAMET: Let me check, 20 Daniel, do you have any comments on this point 21 before I forget that there are people on the 22 phone? Okay, guess not. Chris?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 108 1 DR. FREY: Yes, I'm happy with the 2 idea of not eliminating it, just to follow up 3 on Fred's comments. But I think also, if we 4 think about the ISA, I mean, we have 5 encouraged EPA to write, you know, a preamble, 6 an executive summary, an integrative chapter. 7 And so someone who, you know, 8 reads a short summary of the ISA here can go 9 to a fairly short summary in the ISA itself, 10 that is a little bit more detailed. And then, 11 if they really want the full thing they can 12 read all the chapters. 13 So I think we have a kind of 14 layered approach to, you know, if the 15 reader's really interested, it's not that hard 16 to go. And, you know, if these are on the Web 17 and hyperlinked it would be easy to bring 18 people to the more detailed content. 19 CHAIR SAMET: So, I think you've 20 had a range of opinions. I think with the 21 idea of a quote targeted summary, I think one 22 problem with what is here, it's not clear why

### 202-234-4433 Neal R. Gross & Co., Inc. Page 109 1 it's here. 2 And whether you've picked the most 3 important things and studies that you're going 4 to rely on most heavily, or whatever. 5 And then, you know, there's text 6 here that just doesn't need to be here. Page 7 268, future studies of these and other genes 8 and human populations will be important for 9 determining the role of each genotype and its 10 effect on risk, as well as finding coherence 11 across the disciplines. Strike it out. 12 I mean, you know, there's, just go 13 back and, you know, this is certainly not the 14 place to speculate about what might be needed 15 in the future. 16 So, I mean, I think there's a lot 17 of people commenting on this already, just at 18 this point, loose writing here that needs to 19 be fixed. 20 But I think, you know, you're 21 going to decide what you need to do, but I 22 think this needs to read in a way that says,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 okay, here's Chapter 2. You have this huge 2 ISA, and here's some things we're bringing 3 forward to discuss more importantly, to 4 discuss in the PA, because of blank, because 5 these are the most important, because these 6 are critical studies, because these are the 7 new advances. Whatever it is, so the reader 8 actually knows why the material's here. 9 And, I think, when I read this 10 it's just, it's very hard to understand why 11 you picked one thing and not another. I 12 think, which is the basic problem. Fred?

13 DR. MILLER: I don't know who 14 provided the comment, but I think the idea of 15 making sure that this sets up for the kinds of 16 analyses that are done in Chapter 4, it really 17 ought to be the thrust of this. 18 And a lot of this other is extra 19 verbiage, as you're indicating. And so if 20 they take it that way, then the Chapter really 21 becomes not only shorter, more focused, but 22 also underpins what kind of analyses and why

### 202-234-4433 Neal R. Gross & Co., Inc. Page 111 1 they need to be done. 2 CHAIR SAMET: Okay. So let's do 3 Chapter -- 4 (Off microphone comment). 5 CHAIR SAMET: Okay. Yes, Peter. 6 DR. WOODBURY: I'd just like to 7 register my agreement with this. And we 8 discussed yesterday sort of this cone idea 9 that we're going from the large ISA to the 10 risk assessments, to the policy documents. 11 So, I think, you know, that 12 narrowing down would imply that the policy 13 document is resting most heavily on the risk 14 assessments, and should not be spending so 15 much time on the ISA. I think I may be trying 16 to summarize a few recent comments here. 17 CHAIR SAMET: Okay. Thanks. Is 18 everybody okay with moving to Chapter 3? 19 Okay. So let's do Chapter 3, because we're 20 going to lose Helen. 21 DR. NUGENT: Do you have to leave 22 right after Jack?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 112 1 CHAIR SAMET: We do, Jack.

2 DR. NUGENT: Jack.

3 CHAIR SAMET: He volunteered. 4 Chapter 3, Helen. 5 DR. SUH: Okay. So can you hear

6 me?

7 CHAIR SAMET: Yes. 8 DR. SUH: So, actually, in some 9 ways Chapter 3, the comments echo what's been 10 voiced for Chapter 2. So Chapter 3 is really 11 a overview of the REA, the findings. 12 And I thought, actually, that the 13 summary was fine. And that it was clear and 14 it brought forward the major findings from the 15 exposure and the risk assessment. 16 And there were two parts to the 17 charge question. One was, was it clear; but 18 two, was it necessary. I guess, you know, it 19 is just a very strict summary of the findings. 20 And there's no interpretation or 21 no discussion about how those findings pertain 22 to later judgments. And I guess, as it is,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 113 1 you know, then you start to question about 2 whether or not it's really necessary. 3 And I think, just as I had said 4 for the previous chapter, I think that such a 5 chapter is important, but perhaps at the 6 beginning of the chapter there could be a 7 overview about what the summary's intended to

8 do. 9 And instead of being a summary of, 10 really just a flat summary of the results, 11 it'd be a summary of what is being brought 12 forward and why. 13 And then perhaps at the end there 14 could be a discussion about how these findings 15 might be related, will be related or will be 16 used in the subsequent Chapter 4. 17 So I think, perhaps, a targeted 18 summary with more contexts about its 19 importance would, I think, be helpful. So, as 20 it is now, I don't think it's that useful, you 21 know, and I would maybe argue that maybe it 22 could be dropped.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 But I think that if it became a 2 targeted summary, with some more 3 interpretation and explanation of why this is 4 related to the PA, and why these findings, the 5 ones that are being brought forward, I think, 6 then it would be a very important and useful 7 addition. 8 CHAIR SAMET: Okay. Thank you. 9 Mike? 10 DR. FOSTER: So I agree with 11 everything Helen has said so far, in terms of 12 redundancy, of some of the information. But 13 I think, Scott, in your introduction, you 14 emphasized that you wanted to bring in at the 15 preliminary results were good estimates of 16 exposure, estimates of mortality, hospital 17 administrations and respiratory effects based 18 on epidemiology studies. 19 And I think this is a really good 20 summary, the way you've approached it from the 21 ISA, which as other people have said, it's 22 been through its third iteration, so there's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 115 1 plenty of discussion of that. And I think 2 you've folded it in fairly well. It's 3 informative kind of background for the policy. 4 But, the other part of the, a 5 little bit on risk assessment and risk 6 exposure, is out of my kind of area of 7 expertise. But it is alluded to the fact that 8 in the next iteration of the policy you'll be 9 spending time on pulmonary function per se, 10 and obviously, I'll be able to weigh in much 11 more heavily on that. 12 The other thing is, I think, 13 intentionally, sometimes people intentionally 14 do redundancy because you're trying to drive 15 home an impact. 16 But there's clearly, as you 17 probably know, in Chapter 4 and Chapter 3, 18 there's clearly pages that are absolutely, 19 it's in my notes to you earlier, that are 20 completely identical. 21 So there's a reason for that, I'm 22 presuming, but from wordsmithing, you could,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 116 1 you've heard already, that you could probably 2 be more economy. Thank you, Jon. 3 CHAIR SAMET: Okay. Jim? 4 DR. ULTMAN: Yes, I didn't really 5 have much to add to what, I agree with what 6 was said before. The only additional comment 7 I had was that, there was a use of text where 8 I think tables, or I'm sorry, yes, where 9 tables could be more effective. 10 And for example, some of the 11 bullet items you used to summarize the risk 12 assessment on Page 3.7 and 3.8, for example. 13 It's just kind of bullet items listing

14 results. 15 But if you can put them in a 16 table, it makes it easier to appreciate them. 17 And then you can bring in a little bit more 18 information instead of just talking about just 19 one population, for example. You could 20 compare two populations in the same table. 21 So I would just go to some tables 22 and that will cut down on maybe in the text a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 117 1 little bit as well. And obviously, this 2 direct redundancy, it's bothersome. 3 You know, if you're going to put a 4 table in Chapter 3, and you want to use the 5 information in Chapter 4, just refer back to 6 the table, don't repeat it. The other thing 7 I thought were that some figures would help 8 explain the risk assessment process, it might 9 help people a little bit. 10 So you can see exactly what the 11 input data is and what the output data is and 12 how that data is being processed. Some type

13 of a table. 14 There's already figures in the 15 REA, Example 3.1 and 3.2 are currently in 16 there or something along those lines, 17 explaining this process. And that's about it. 18 CHAIR SAMET: Okay. Thanks. 19 Mike, I would like to bestow on you the honor 20 of summarizing for Chapter -- 21 DR. FOSTER: Graciously accept. 22 CHAIR SAMET: Thank you. Other

### 202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 comments on Chapter 3? Fred? 2 DR. MILLER: Just like with 3 Chapter 2, setting up 3, to me, the third 4 charge question for Chapter 4 would greatly 5 benefit by looking at some of the 6 distributions that you're talking about in a 7 subsections of them and laying this out in 8 Chapter 3. 9 Because that is one of the areas 10 where you're talking about the studies where 11 the dose metric was above the standard and how 12 to partition out. 13 And so, to me, this is where you 14 do the set up for what kind of information. 15 And in Chapter 4 in the current draft, you 16 just elude to some numbers and postulating and 17 wanting feedback. 18 But as you do the analyses that 19 would maybe support that, they belong in this 20 Chapter, and that would give it the focus 21 that, again, setting up for what needs to 22 underpin what you want to do in Chapter 4.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 119 1 CHAIR SAMET: Okay. Anyone else, 2 anyone on the phone, Daniel? Maybe not there. 3 Any other comments? Just, I'll point out on 4 the Page 314, you have this discussion of 5 quote key sources and variability and 6 uncertainty, which, first of all, it's just 7 cribbed. We've seen this about seven times. 8 It appears in every chapter. 9 But, second, this is probably not 10 the right place for it. And certainly, if 11 this is the set up for discussing variability 12 and uncertainty, that would probably be better 13 placed in Chapter 1 and offer better framing 14 of the concept. Okay, other comments here? 15 Okay, so, I would suggest, that we 16 take a quick break till 10:30 a.m., and give 17 everybody a chance to check out. So let's try 18 to get back by 10:30 a.m. 19 (Whereupon, the above-entitled

20 matter went off the record at 10:19 a.m. and 21 resumed at 10:30 a.m.) 22 CHAIR SAMET: If everybody could

### 202-234-4433 Neal R. Gross & Co., Inc. Page 120 1 take their seats, we're going to get going. 2 So, if everybody could take their seats. The 3 taxicabs are lining up and people are getting 4 antsy. 5 All right, a couple of quick 6 comments. One is that, those of you who are 7 doing the response on the charge questions 8 that have been designated on the chapter 9 reviews, remember that you need to develop the 10 answer to the charge questions based on what 11 you and your colleagues have written, 12 amplified by the discussion here. 13 So if you could remember, that's 14 what you need to do. So we do need to respond 15 to the charge questions and shape that. 16 And then, I think, when we talk 17 about this on the phone, the important points 18 that we want to bring forward to the letter, 19 letters, in fact, we will need to pull those 20 out. And I think those have been some of the 21 major topics of discussion around the table 22 today.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 121 1 I think the other, usually I'll 2 turn to Angela for this, would be the schedule 3 for getting these, and again, following usual 4 practice. 5 We'd like to get these in quickly. 6 And we will, of course, have a follow-up phone 7 call to review the first draft's letter and 8 comments to the Administrator. 9 DR. NUGENT: Right. So we'll be 10 in touch about follow-up teleconference likely 11 to happen some time in October. But, you 12 know, I'm one of these people who like things 13 to happen quickly. 14 And, you know, would it be 15 unreasonable to ask for your comments within 16 the week, you know, while it's fresh in your 17 mind for the write ups? Hearing that's okay, 18 and no disagreement, let it be. So thank you. 19 A week from today, next Thursday. 20 You can, the SAB Staff Office is 21 going to kind of work together on the next 22 step, so I may not be your point of contact,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 but you can send the comments to me, and I'll 2 make sure that the right people get them.

3 CHAIR SAMET: Go ahead. 4 DR. MILLER: One clarifying 5 question is, as we're working with the 6 subgroup that is charged with, you know, 7 integrating like per se, Chapter 7 comments, 8 do we have to copy the DFO on all of us, or 9 you just want the final thing from the first 10 in charge, which is it? 11 DR. NUGENT: Please copy me on all

12 the -- 13 DR. MILLER: Okay. 14 DR. NUGENT: -- communications

15 related -- 16 DR. MILLER: All right. 17 DR. NUGENT: -- toward this Panel. 18 DR. MILLER: Okay. I hope you 19 have a large email box. 20 (Laughter) 21 CHAIR SAMET: Okay, let's go to 22 Chapter 4. Chris?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 123 1 DR. FREY: Okay. Let's see, 2 Chapter 4, I think there were several charge 3 questions, if I'm correct. And so, in 4 answering the charge questions, I'll focus on 5 that and then I'll say some other things. 6 So, I think for the first one, 7 basically is how does this chapter 8 characterize and consider available health 9 evidence and so on, in reaching the 10 conclusions about the adequacy of the current

11 standard? 12 I think the material is there for 13 the reader to come away with the idea there's 14 a strong justification for the conclusion that 15 the current standard is not adequate. 16 And the term preliminary is used 17 in front of conclusion, the preliminary could 18 be deleted throughout. But I think the 19 rationale is not clear. And the chapter 20 really needs a conceptual framework to help 21 the reader understand why things are in the 22 chapter, or why things are not in the chapter.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 124 1 So, I mean, clearly, the 2 determination has to do with weight of 3 evidence. It has to do with short-term risk 4 assessment. It has to do with long-term risk 5 assessment, and so some overview of that. 6 And a preview of, you know, which 7 were the most significant considerations among 8 say those three categories, or maybe there's 9 better ways to catagorize it. And then within 10 those categories there's additional 11 considerations. 12 And it seems to me, that the 13 chapter spends a lot of time, and is very 14 repetitive about epidemiologic studies from 15 the perspective of whether the conditions of 16 the air quality data for those studies were in 17 compliance with the standard or not, and 18 what's the design value. 19 And, as a reader, I really could 20 not figure out why that was there. I think I 21 could invent reasons for why it was there, but 22 it was never articulated.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 125 1 So I found it a very frustrating 2 chapter to read. And as I will say later,3 it's very repetitive. Parts of it are well4 written, but parts of it, or aspects of it are 5 very poorly written. 6 It was to the point where if a 7 student had turned that into me I would have 8 just given it back and said, you know, do this

9 over. 10 So I hate to be that harsh, but 11 for something that goes to a panel of 20 12 really busy people, it just, to me, was not an 13 acceptable piece of writing. 14 So, you know, for example, in the 15 epidemiological thing, there's discussions 16 about what seems to be implied as an exclusion 17 criteria for maybe not considering epi 18 studies, which is that, the design value of 19 air quality during the time period of the epi 20 study was above the standard. 21 And there's a lot of discussion of 22 that, and with regard to short-term epi

### 202-234-4433 Neal R. Gross & Co., Inc. Page 126 1 studies. And I couldn't figure out, why do we 2 care for a short-term epi study about a design 3 value, which, by the way, the definition of 4 that is based on a three year average of 5 fourth highest annual, you know, daily maximum 6 eight hour values. 7 So what epi study uses that as the 8 metric of exposure? I don't think any epi 9 study ever has used the design value. So I 10 couldn't figure out, why is that relevant to 11 looking at the validity of the concentration 12 response function at levels either above the 13 standard, or particularly below the standard. 14 I think the relevant scientific 15 question is, is there adequate data in the epi 16 study at the averaging time of interest that 17 is below the levels of the current standard, 18 and can we use that in risk assessment? 19 Now I could imagine, if there were 20 epi studies at areas with design values below 21 the current standard, that would give us more 22 direct empirical evidence as to the health

### 202-234-4433 Neal R. Gross & Co., Inc. Page 127 1 effects below the standard, but the document 2 never says that very clearly. I couldn't find

3 that. 4 So I could see why it would nice 5 if we had such studies, but the fact that we 6 don't have such studies by in large, to me, 7 doesn't, it's not a significant shortcoming of 8 the scientific evidence.

9 So I have a lot of comments on 10 this point, just because it comes up over and 11 over and over again in the chapter, which is12 also just another indication it's not well13 organized. 14 This issue should be addressed 15 once and, you know, dispatched, and then move 16 on to something else. John, you want to do 17 all the charge questions? I'll do the other 18 charge questions here, okay. 19 So then, the second charge 20 question, to what extent does the PA help 21 inform looking at alternative standards? 22 So, I think, you know, it's very

### 202-234-4433 Neal R. Gross & Co., Inc. Page 128 1 clear, I thought it was extremely clear that, 2 you know, 70 ppb is a level that ought to be

3 looked at. It's been looked at before. 4 Evidence is still there that 5 that's probably more health protective than 6 the current standard, which is not adequately 7 protective, which I think, is well-established 8 in the PA. 9 And 60 ppb also makes sense as a 10 level to look at. I think there's some places 11 where the document talks about 80 ppb. I 12 think there's no need to address 80 ppb 13 anymore. 14 Maybe there was some other reason 15 for that, but again, there's no conceptual 16 framework for the chapter, so I don't know why

17 that was there. 18 The Policy Assessment provides, 19 but doesn't state, and again, you know, if EPA 20 wants our reaction to things, I would rather 21 they propose what they want to do. 22 What is it that they want to do

### 202-234-4433 Neal R. Gross & Co., Inc. Page 129 1 below 60, if anything? I think an argument 2 could be made to look at 55. An argument

3 could be made to look at 50. That would be an 4 interesting discussion to have. I don't know 5 if that's a discussion we want to have today. 6 But, anyway, I think there's information there

7 as far as a short-term health standard. 8 There's a preliminary conclusion9 that there's not a need to consider a long10 term average for a new health standard. And, 11 I couldn't really figure out the rational for 12 that conclusion. And not that I necessarily 13 disagree with it, but just as it was stated, 14 I didn't really get why that was a conclusion. 15 You know, there is likely, I think 16 it was likely to be causal for long-term 17 effects from the ISA for long-term. And, you 18 know, there is a significant body of evidence 19 related to that. So it wasn't clear that that 20 could easily be dismissed. 21 And I'm not arguing that it should 22 be included, but I guess, I'm arguing for a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 clear articulation of why it's implied that 2 that's not going to be pursued. 3 Now there is some other language 4 in this chapter that says, to the effect that, 5 well, setting a short-term standard could also 6 be protective of longer term average related 7 health effects, and that there would be some 8 analyses of air quality relationships to look

9 at that. 10 And I think that's good and I 11 certainly support that analysis. But, I 12 guess, I would just like more clarity on EPA's 13 thinking behind why not consider a longer term

14 standard. 15 Okay. Then, moving on to the 16 third charge question. So, I guess I won't 17 read the whole thing, but as far as the 18 question, you have it up on the screen. 19 My general thought was that this 20 chapter, this section of the document was 21 generally reasonable. But that, I really 22 think the key factors to consider, when

### 202-234-4433 Neal R. Gross & Co., Inc. Page 131 1 looking at the relevance of these epi studies, 2 more important than whether the design value 3 was above or below a standard, was the extent 4 to which they're based on air quality data 5 with concentrations that are below the 6 standards, such that we can develop with 7 confidence, concentration response functions 8 that allow us make predictions of health

9 effects below the standard. 10 And something about the level of 11 confidence in those concentration response 12 functions and a range of interest, I suspect 13 50 to 75 ppb is going to be a key range of 14 interest. 15 Below 50, that, we may be 16 interested in, and I think, as Fred as talked 17 about, maybe looking at what is the risk 18 associated with background concentration, so 19 that might be roughly 30 to 50 ppb down to

20 zero. 21 But, I think, in terms of what I 22 understood Bryan Hubbell to describe, looking

### 202-234-4433 Neal R. Gross & Co., Inc. Page 132 1 at the incremental risk reduction of the 2 current standard to alternative levels, that's 3 likely to be in the range of 75, as the 4 current standard looking at 70, 60, 50, 55. 5 It's not clear what might happen below 60 in 6 this analysis. 7 But I think if we have epi studies 8 that are, you know, have good empirical bases 9 in those concentration ranges, whether it was 10 the design value of the current standard or 11 not, to me, seems irrelevant. 12 I have a lot of detailed comments, 13 which I am not going to go through. I am 14 going to say, just, I know Vanessa doesn't 15 want us to spend our time editing, but I just, 16 I have tremendous respect for OAQPS, but this 17 is the worst written chapter I've ever read in 18 my time on CASAC. 19 And I have a lot of suggestions 20 for how to improve it. I think it could be 21 much better and much shorter. And I put in a 22 few examples, just to illustrate, you know,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 133 1 when I say, you could cut things by 90 2 percent, I really mean it. 3 I mean, you could take five lines 4 of text and replace it with the word 5 therefore, and no loss of content. So I 6 really encourage someone to do some editing of 7 this chapter. Because it's going to lose its 8 punch if it's way too long and wordy and 9 repetitive. 10 You know, to me, a policy 11 assessment should be the most accessible, easy 12 read of all of these documents, because this 13 is going to go on beyond our technical 14 community to decision-makers, and it's really 15 critical that it be easy to read. That's it. 16 CHAIR SAMET: Okay. Thanks. 17 Chris, loved it. Okay, Ed? 18 MR. AVOL: I just have a couple of 19 things, one of the advantages of going after 20 Chris. I think a lot of the elements are in 21 place here, but some of them are just 22 promised, about to be delivered, but not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 delivered on here. 2 And then, as it had been 3 mentioned, there's a lot of repetition and a 4 lot of extra stuff. There are a couple of 5 things that I want to comment on, because in 6 some cases, I think, the wrong perspective is 7 given, or potentially, maybe it's just not as 8 neater, maybe it's a little too sloppy. 9 And so on one case, for example, 10 at the end of Page 4.4 there was talking 11 about, the end of the paragraph, it talks 12 about recognizing that a zero risk standard is 13 not required by the Clean Air Act. And that's 14 true, but the tenor or it, I think, is not 15 quite right. 16 For me, the issue is not so much 17 that zero risk standard, which is true, but 18 rather that the public's health with an 19 adequate margin of safety is the issue. And 20 so, I think, that it's maybe just a 21 perspective, but I think it's a different way 22 of sort of how it's presented.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 135 1 And there's a section in there 2 where it talked about some of the information 3 on lung function results and use of the word 4 normal. Now I'm from California, so the use

5 of the word normal has no context for me. 6 (Laughter) 7 MR. AVOL: But, you know, in 8 health effects studies and research, the only 9 way I could qualify the use of normal would be 10 if it was, you know, age, height, gender, race 11 adjusted, and so, I think, you can't just sort 12 of throw around normal. That's just another 13 example, I think, of where the wording is sort 14 of a little loose. 15 There's a comment later on Page 16 4.40, about the likelihood that the serious 17 adverse responses to ozone exposure's likely 18 relate to frequency of exposures. And to some 19 extent that's true, but I don't want you to 20 forget that, you know, there is a phenomena 21 known as toleration or adaptation. 22 And so, for out of seasonal, one

### 202-234-4433 Neal R. Gross & Co., Inc. Page 136 1 exposure in the early Spring has been shown to 2 be pretty effective in terms of the listening 3 response, if you haven't been previously 4 exposed. 5 So it's not just the case that the 6 long exposure effects, there's been 7 information that data has shown that 8 repetitive exposure sometimes blunts the 9 response. So I think, take a look at that and

10 sort of look at that. 11 Finally, not to beat on something 12 that we've already beat on for a couple days, 13 but I mention it, at Page 453 there's this 14 conversation about long-range transport and 15 background and exceptional events and so

16 forth. 17 And again, in the context of the 18 background discussion and what's in and what's 19 out, and I think you should take a look at 20 that and sort of try to tighten it up. But as 21 Chris mentioned, probably tightening up the 22 whole chapter, I think, would be something

### 202-234-4433 Neal R. Gross & Co., Inc. Page 137 1 that would be well done. 2 CHAIR SAMET: Okay. Thanks.

3 Fred? 4 DR. MILLER: Well, I hardly know 5 where to begin, because I'll make the analogy 6 to the political Republican and Democratic 7 views. 8 I am as far away from Chris on 9 this chapter as you could possibly get. I 10 have read lots of policy documents and things 11 and this is the most well-written chapter that

12 I have ever read. 13 (Laughter) 14 DR. MILLER: For example, Section 15 4.2.1, you couldn't write a better legal brief 16 than what this has. If I had to make the 17 analogy to Perry Mason and to Matlock, all the 18 evidence about how you put it out, you say 19 what you need to have and then you go and you 20 interpret and you say how you're going to use 21 it. 22 It's all here, and then Matlock

### 202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 comes in and explains it in common language 2 such that we the jurors can follow it. So I 3 am absolutely totally at the other end. 4 And I don't know, maybe this is a 5 function of how many of these I've read, or 6 what, but I just cannot agree with you in 7 terms of what is the goal. 8 And one of the things that you put 9 on in terms of concentration response 10 functions, I don't think is an understanding 11 of how with the metric being in the particular 12 study, how they have to incorporate that 13 concentration response and are trying to look 14 at the segments of the over all time series 15 analysis and the ozone concentrations, and get 16 out the portion that are relevant when they 17 are talking about going to alternative 18 standard levels. So it's just an absolute 19 requirement. 20 So, and there's sections in terms 21 of, that are more difficult to explain, like 22 4.2.2. It's concisely written, but the topic

### 202-234-4433 Neal R. Gross & Co., Inc. Page 139 1 is much more difficult to convey. 2 The draft on the integrative 3 consideration of the risk, they only need two 4 pages to totally define what's going on about 5 the first draft exposure and the available 6 information and the reasonableness of 7 considering a range of possible alternative

8 standards. 9 I can tell you, there are other 10 documents where this rambled for pages. So 11 I'm just, I don't know where we were when we 12 read that, but I still just can't agree with 13 you there. 14 In terms of the second charge 15 question, staff clearly present the support 16 for looking at alternative ranges between 60 17 and 70. But when they then go into the 18 consideration of levels below, the pros and 19 cons of this, I thought we would need 20 discussion here, and basically, in my opinion, 21 the scientific weight of the evidence is not 22 sufficient to go below 60 parts per billion at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 140 1 this time. 2 The recent McDonnell Paper clearly 3 establishes a threshold for changes in FEV1 4 that to ozone exposure. There are only a few 5 epi studies where the design value is below 6 the current standard. Okay? And one of 7 those is the Mar and Koenig Study at .71. 8 And so you clearly have a full 9 blown epi study that shows that the current 10 standard is not protective. Now you have to 11 extract out from that the portions so you can 12 get to the alternative risk estimates. 13 And the other part of it is the 14 fact that as you go to lower and lower 15 alternative standards, then the delta from the 16 background to non-anthropogenic sources, it 17 becomes much more of an issue. 18 And so, looking at the science and 19 the weight of the evidence, I still see that 20 60 is the lowest level that I see the science 21 having a worthwhile investment of their time 22 for exploring alternative in the range of 60

### 202-234-4433 Neal R. Gross & Co., Inc. Page 141 1 to 70. 2 In terms of the third charge 3 question about what they can do in terms of 4 extracting data from these different studies, 5 and they explain how the confidence limit 6 widens in the range of the 30 to 50 ppb. 7 And I think this is likely a 8 function of the smoothing function that was 9 used in the study. So, for example, in the 10 Bell, et al., they used a cubic spline. 11 Others used difference. 12 And in terms of the statistical 13 distribution and the mean's central tenancies, 14 these become factors as you take segments of 15 the thing. 16 So it's not surprising to me, but 17 it does become problematic when you pose the 18 question, how could you use subsets of the 19 percentiles of the distributions in the CR 20 functions that you have to examine for the 21 alternatives. 22 And I offer the suggestion that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 you could take five to ten ppb intervals, and 2 then use the variance of the observations in 3 the time series in your air quality data in 4 those ranges as a weighting function in your 5 CR functions. 6 And then you can check the 7 reasonableness of this by contrasting what you 8 get when you're now estimate risk compared to 9 what in the, and I would take specifically the 10 Mar and Koenig Study, because there it's 11 below, the design value's below, and I would 12 compare for your different weighting and 13 alternative weights that you may come up with. 14 How you aggregate up compared to 15 what's in the total risk that you estimate 16 from that study. 17 And that gives you a very good 18 idea of the statistical robustness of the 19 schemes that you're talking about and being 20 able to then sub-fractionate in terms of the 21 distributions in that. 22 So whatever you do, you're going

### 202-234-4433 Neal R. Gross & Co., Inc. Page 143 1 to need to identify how that fits in, because 2 that's going to put these alternative 3 standards that we could be proposed into a 4 better assessment of things. 5 CHAIR SAMET: Fred, just, I think 6 in the next five minutes or so we need to move 7 on to the other chapters, because we're going 8 to lose some of our colleagues. So I just

9 wanted to -- 10 DR. MILLER: Okay, I'll do one

11 last -- 12 CHAIR SAMET: -- call for brevity. 13 Okay. 14 DR. MILLER: Is that okay?

15 CHAIR SAMET: Yes. 16 DR. MILLER: Okay. It has to do 17 with on 447.3, I don't think that I've read 18 anything in the ISA, the REA, or others, that 19 convinces me that the statistical form of the 20 standard should not be revisited to examine 21 its robustness as you go to alternative level 22 standards. And so I offer that as something

### 202-234-4433 Neal R. Gross & Co., Inc. Page 144 1 I think needs to be explored. 2 CHAIR SAMET: I will say, just on 3 this counterpoint between Chris and Fred. 4 There may be, maybe you're saying the right 5 things, but it's perhaps also a matter of how 6 you say it. 7 And if you look, for example, at 8 the first paragraph on Page 412, there's an 11 9 line sentence that probably deserves to be 10 four sentences. And there are many, many 11 examples of that. 12 And I think that, you know, so 13 maybe the right stuff is there, which is kind 14 of what Fred is saying. But I do think it's 15 a little bit impenetrable in places. 16 And that's just one example I bring to your 17 attention. Ana? 18 DR. MILLER: And that's the kind 19 of thing I'm willing to overlook at this 20 point. But I agree with you. I know what you

21 meant. 22 DR. NUGENT: Okay. So, I read

### 202-234-4433 Neal R. Gross & Co., Inc. Page 145 1 this very much as a draft. So, I think the 2 chapter has a lot of good stuff in it. I 3 think I agree with others, that perhaps, one 4 of the issues is to establish what the focus 5 and objective is, very clearly. 6 And I think, primarily, this 7 chapter, I think, needs to state what the key 8 points that are crucial to revisiting the 9 standard are, and what new evidence relevant 10 to these points makes this revision necessary. 11 So that's kind of, I think, what you want to 12 transmit. 13 What are the key points that one 14 would have to consider if one were thinking 15 about revising a standard, and do we have 16 evidence on those points that suggests that we 17 need to revisit it and what it is. 18 I think what you don't want to do 19 is revisit conclusions that were previously 20 arrived at in the other documents. And you do 21 a little bit of that, and I think that's, you 22 know, can be problematic.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 So I think the document probably 2 has to have some synthesis. And actually, I 3 thought some of the syntheses that was in it 4 was actually quite good. Perhaps it needs to 5 be even more synthetic. 6 I mean, I found the PA better 7 written than the previous documents, actually. 8 I found it easier to read. I don't know if 9 I'd got used to reading the stuff, or what,

10 but -- 11 (Laughter) 12 DR. NUGENT: But I think you need 13 to have some synthesis, because people who 14 read the PA, aren't going to go back and wade 15 through the ISA, but I think it needs to be 16 very synthetic and to the point. 17 You know, what's crucial for, 18 what's the decision going to be based on and 19 what's the new point that we need to 20 highlight? 21 I think the, I also found the 22 whole issue of the design values not very

### 202-234-4433 Neal R. Gross & Co., Inc. Page 147 1 useful, because of this issue that, yes, I 2 mean, even epidemiologic studies that have a 3 median value, or whatever, above the standard 4 can be informative, because they may have 5 distributions that go way down. So I found 6 that confusing. 7 So that's in terms of the first 8 point. In terms of the second point, the 9 second question, you know, I agree with, I 10 think, previous reviewers that, you know, 11 certainly, looking at 60 makes a lot of sense. 12 I think for comparison purposes, 13 and that this, I'm sure we'll talk about, 14 maybe looking somewhat lower than that might 15 also be useful, even if it's only for 16 comparison purposes. 17 In terms of the third point, 18 you're asking for some guidance on how the 19 epidemiologic data can be used. Again, I 20 think you don't want to, I mean, supposedly 21 the ISI reaches some conclusions, based on the 22 epidemiologic data and the REA, just some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 148 1 analyses that use the epidemiologic data to 2 help us understand the impact of changing the

3 standard. 4 So I don't think you want to kind 5 of reopen that whole thing up here. And I was 6 a little bit confused about whether that's 7 what you wanted to do or not. 8 But in any case, in terms of the 9 general question, I think it's important to 10 remember that what the goal of the 11 epidemiologic studies is. 12 And I think the goal of the 13 epidemiologic studies, and my epidemiologic 14 colleagues may want to chime in on this, but 15 from my perspective, it's really to establish 16 whether there is a causal relation between 17 ozone and certain outcomes, and what the form 18 of that relation is, and what the strength of 19 that relation is. 20 So I think it's rare that you're 21 going to be able to take an epidemiologic 22 study and use it to determine this should be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 149 1 the standard, or even a collection of 2 epidemiologic studies. 3 I think the best you can do, and I 4 think it's what you're doing, is to, you know, 5 simulate population changes in exposures under 6 varying standards and these varying standards 7 could be varying levels, in forms, in 8 averaging periods, whatever, simulate what the 9 new continuous distribution would be. 10 And I emphasize continuous, 11 because of this, you know, apparently linear 12 relation, what the new continuous distribution

13 that we would observe would be. 14 And I would do that with the 15 lowest level aggregation possible in the time. 16 So, you know, with the lowest common 17 denominator. 18 And then from that distribution 19 derive the measures that were used in the 20 Epidemiologic studies, eight-hour averages, 21 24-hour averages, whatever, and combine those 22 with the dose response function to predict the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 150 1 deaths and then use that to estimate how many 2 deaths were saved on various scenarios. 3 And I think that's really the best 4 you can do in terms of how to use the 5 epidemiologic data. And, you know, if you can 6 simulate the changes in the population 7 distribution using the lowest common 8 denominator, then you can aggregate up in 9 different ways and predict using, you know, 10 taking the dose response functions directly 11 from epidemiologic studies that use different 12 averaging periods, or whatever, and you don't 13 need to worry about matching everything up. 14 I'm not sure if I'm being clear, 15 but, so, have the lowest common denominator 16 for the distribution so that then you could 17 aggregate up and use it in various ways, and 18 use that to compare various standards. 19 So that's my suggestion of how the 20 epidemiologic data can be used to inform the 21 actual level of the standard through that kind 22 of, the level and the form of the standard

### 202-234-4433 Neal R. Gross & Co., Inc. Page 151 1 through that kind of comparison. I think 2 that's it. 3 CHAIR SAMET: Okay. Thanks. And 4 actually, would you take on the role of 5 summarizing, because I'm afraid to ask Chris

6 or Fred. 7 (Laughter) 8 DR. NUGENT: Okay.

9 CHAIR SAMET: We need a neutral 10 person. If you don't mind, I think, we could 11 come back to this, if needed, but I would 12 really like to make sure we have time while 13 our welfare team is here. 14 So I think we should move to 15 Chapter 5, Kathy, and that's you, let's lead,

16 or start. 17 DR. WEATHERS: Okay. 18 DR. ULTMAN: Do we have time, 19 short time for one comment on Chapter 4, or

20 no? 21 CHAIR SAMET: If you could hold 22 it, we'll come back, I promise, we'll come

### 202-234-4433 Neal R. Gross & Co., Inc. Page 152 1 back to Chapter 4. 2 DR. ULTMAN: Oh, okay. 3 CHAIR SAMET: Okay. Are you 4 leaving too?

5 DR. ULTMAN: At 11:45 a.m.

6 CHAIR SAMET: A short comment on 7 Chapter 4?

8 DR. ULTMAN: A short comment. The 9 most concise part of the chapter was Section 10 4.2.2.2 on estimates of ozone induced lung 11 functioning impairment. Because it hadn't 12 been done yet, so it's not in here. 13 (Laughter) 14 DR. ULTMAN: It took up four 15 sentences. At any rate, the ISA Group is 16 moving in the direction of using McDonnell's 17 2012 model for exposure response for FEV1 in 18 the risk assessment.

19 And that model does have an 20 intercept to it. I don't know if you want to 21 call it a threshold or not, but it does have 22 an intercept associated with it.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 153 1 So some of the ideas of what we 2 did in the past with respect to the FEV1 3 conceptually is going to change a little bit. 4 And I'm sure that'll all get filtered into the

5 next document. 6 But my point has to do really with 7 the fact that that model is indeed used for 8 risk assessment, has a much better, has a 9 better fit, I won't say a much better fit, has 10 a better fit at low concentrations and affords 11 the opportunity to calculate some background 12 risks using that model, with more confidence 13 than we've had before. And this is just for

14 FEV1. 15 So my suggestion was going to be 16 that you consider doing some calculations to 17 compare, you know, the risk assessment under 18 no background situation to the risk 19 assessment, to compare that to just with the 20 background would do. 21 Because I really feel like there 22 has to be some context when you show that, you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 154 1 know, reducing the standard by a certain 2 amount is going to save so many lives. You 3 need some context for that too, to see what 4 the, well, I'm sorry. You do a calculation 5 that shows that so many lives are going to be

6 lost at some level of the standard. 7 We need some context for that, for 8 people to appreciate then with what, if you 9 lower the level, how much of a difference it's 10 really going to make. So I'm just saying, 11 there's a proved opportunity to do that with 12 this document. 13 CHAIR SAMET: Okay. And, Jim, 14 make sure that's, presuming that's reflected 15 in your written --

16 DR. ULTMAN: Pardon me? 17 CHAIR SAMET: Reflected, what you 18 just said is -- 19 DR. ULTMAN: Okay. 20 CHAIR SAMET: -- reflected in your 21 written comments. 22 DR. ULTMAN: I will do that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 155 1 CHAIR SAMET: Okay. Kathy? 2 DR. WEATHERS: Okay. So, going 3 down the questions, I think that the first 4 question we've talked about a little bit in 5 regards to some of the chapters, that this 6 chapter seemed a little bit long and unwieldy 7 and it wasn't clear what the point was. 8 And so refining that, making sure 9 that the chapter points out what's new and 10 what supports the Policy Assessment will be 11 important.

12 It seemed to me that there was too 13 much detail in Section 5.2. It was okay 14 detail in Section 5.3. Again, this falls 15 along the over-arching comments about the 16 level of detail in this chapter.

17 In terms of the focus on the W126 18 Form, I was actually compelled by the history 19 there, and found that section to be useful, 20 and thought it might even be pulled up into 21 the beginning part of the PA document. So, I 22 thought that was quite useful.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 156 1 In terms of Question Number 4, it 2 occurred to me that, in terms of looking at 3 ecosystem effects, yesterday we talked about 4 using some modeling techniques and that PnET 5 might actually be used or some other model to 6 look at potential for water effects, ecosystem

7 level of water effects. So that wasn't 8 identified at all in this version. 9 In terms of Number 5, it seems 10 that here's a place where it's not clear why 11 crop yield and Ag effects weren't considered 12 more fully in terms of adversity. 13 And then, in terms of Question 14 Number 6, it seems okay. It's speculative, in 15 terms of the feedbacks and the chemical soup 16 of the atmosphere and how ozone, tropospheric 17 ozone might interact. 18 But I do think it's important to 19 point out that there are these feedbacks and 20 it is a chemical sympathy atmosphere. So 21 those are my responses to the questions. 22 CHAIR SAMET: Okay. Peter?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 157 1 DR. WOODBURY: Thank you. I have 2 many of the same general concerns for the 3 Policy Assessment that I brought up yesterday 4 for the Risk Analysis. 5 I'm not going to repeat those 6 general points here, but they are in my 7 written comments. And I do have some detailed 8 comments both for Chapters 5 and 6, and I'm 9 not going to try to go through all of those. 10 For Question 1, there's a lot of 11 good material in this chapter that does 12 reflect the ISA. But again, echoing that I 13 think it can be condensed and clarified. 14 And in particular, trying to 15 clarify which points are fairly well-known and 16 where there are areas that really aren't that

17 well-known. 18 There's a lot that we don't know, 19 but there's a lot that is well-known. And 20 just as an example of that from today, the 21 presentation, Vicki, that you made, Slide 11, 22 that language was exceedingly clear and brief.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 158 1 And so, so maybe if you start by, 2 you know, working with some of your slides and 3 other brief presentations and bringing that 4 back in, that will help. 5 For Question 2, I had pretty much 6 the same response. It's, the information's 7 appropriate, but some more effort to clarify 8 what's well-known from what isn't will be 9 helpful. 10 For Question 3, I had some 11 specific comments that I won't go over 12 verbally. For Question 4, I think I, again, 13 I have some specific comments that I won't go

14 over. 15 And I would also echo what Kathy 16 just mentioned, that there are some modeling 17 studies that provide quantitative estimates of 18 some of these effects, how that may be worth 19 mentioning. 20 For Question 5, again, this is 21 helpful and should be retained, but again, 22 clarifying, focusing on the information that's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 159 1 relevant to the rest of this document. 2 In other words, this chapter is 3 supporting the remainder of the document, 4 rather than trying to summarize everything. 5 I think that's it. Thanks. 6 CHAIR SAMET: Okay. Thank you. 7 Howie? 8 DR. NEUFELD: I have very brief 9 comments, because I agree with everything 10 that's been said before. But I also want to 11 put in my voice that, I think, that both the 12 welfare and the PA, should be much shorter and

13 less redundant. 14 I think it dilutes from the actual 15 mission of each of those documents to simply 16 repeat all those ISI things, ISA things. 17 I only want to concentrate on two 18 things. Question 3, I just want to emphasize 19 the utility and the need, okay, and I 20 emphasize the word need to use the W126 Metric

21 for the welfare effects. 22 And then in Question 5, I just

### 202-234-4433 Neal R. Gross & Co., Inc. Page 160 1 want to say that I appreciate the distinction 2 between injury and damage. I liked that 3 discussion there. 4 And also expanding on the adverse 5 effects at the ecosystem level. And I thought 6 this was an illuminating section. Other that, 7 I just had very other brief comments, which 8 you can read. Thanks. 9 CHAIR SAMET: Okay. Thank you. 10 Other comments on Chapter 5?

11 DR. GRANTZ: Yes. 12 CHAIR SAMET: David. 13 DR. GRANTZ: When I first read 14 through this chapter, I was really quite 15 pleased with it. And -- 16 CHAIR SAMET: You can summarize 17 it. 18 DR. GRANTZ: -- until I got to 19 actually Question 3 for the next chapter, 20 which asked if Chapter 6 might be removed from

21 the document. 22 At that point, I went back and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 161 1 thought about what I really thought about 2 Chapter 5. So it's not adequately reflected 3 in the written comments for Chapter 5. 4 But I agree with the discussion 5 we've had previously, that there's way too 6 much, you know, regurgitation of what's in the

7 ISA. 8 And if could be brought together 9 in a few focused points, I think it would be 10 much more powerful. So that's been said, and 11 I won't go over it too much. 12 I think, if this whole process is 13 going to be science-based, either the 14 agricultural data really needs to be featured, 15 because we know an awful a lot about it, or 16 the agency needs to write a very clear 17 paragraph as to why not. 18 I mean, it's just incomprehensible

19 to me that all of that NCLAN data and all of 20 the chamber data with trees and all that kind 21 of stuff is not integrated more fully. I just 22 don't understand that, I can't see it.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 162 1 I think it's not a science-based 2 question, and it needs to be put in some kind 3 of science-based terms. Okay. I think that's 4 really all I need to say there. 5 I agree with Howie, that we need 6 to carry it forward the strong recommendation 7 regarding accumulative weighted standard, that 8 needs to be emphasized at every step in this 9 process and it needs to come out in the letter 10 as it was done previously. 11 CHAIR SAMET: Okay. Thank you.

12 Peter?13 DR. WOODBURY: So one of my over14 arching comments yesterday was on this topic. 15 That there really needs to be a greater 16 analysis and inclusion of effects on crop 17 yield loss. 18 So I will repeat that and just 19 echo what Dave just said. Except that I would 20 differ in that I don't think there's any 21 rational for excluding that information and 22 for excluding analyses, additional analyses of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 163 1 crop yield loss. 2 I think the exposure response 3 functions are available. There are reasonable 4 estimates for much of the country of exposure 5 patterns, and that's quantifiable. 6 So there's no reason not to, 7 again, expand that analyses in the welfare 8 assessment. And then, obviously, that gets 9 brought forward here.

10 I would also echo the comments 11 that we definitely need the accumulative 12 seasonal standard and that the W126 Form is 13 useful and appropriate. 14 CHAIR SAMET: Howie?

15 DR. NEUFELD: Just to echo the 16 comments on crops, I just say Ibid. 17 CHAIR SAMET: Okay. Kathy. 18 DR. WEATHERS: I just wondered 19 whether there was actually a reason, from the 20 EPA's perspective, so turn around and ask the 21 question, is there a particular reason why the 22 crop assessments were not highlighted?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 164 1 MS. SANDIFORD: Just as Karen 2 Martin gave a very long history lesson 3 earlier, we could do the same for the rational 4 on the crops, but I don't think it's worth 5 going into here. We do appreciate your

6 comments. 7 DR. GRANTZ: Can you summarize 8 whether that is a science-based decision?9 MS. SANDIFORD: It's a policy10 based decision. 11 DR. GRANTZ: This is, at least the 12 first two of these documents are not policy

13 documents. 14 MS. SANDIFORD: Chapter 5, I 15 definitely agree could be expanded to include 16 the crop information in Chapter 6, whatever is 17 added to the Risk and Exposure Assessment. 18 Once we get to Chapter 7, I don't think I can 19 speak to that at this point. 20 CHAIR SAMET: Okay. And, Kathy, 21 you've agreed to summarize that?

22 DR. WEATHERS: Yes.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 165 1 CHAIR SAMET: Yes. Okay, other 2 comments on Chapter 5? 3 (No response.) 4 CHAIR SAMET: Okay. On to 6? 5 That's your -- 6 DR. WEATHERS: I think I'll make 7 some general comments on 6, and one is, 8 actually specific to yesterday's conversation, 9 as well, which is where fusion models are 10 introduced. 11 I think, in all places where they 12 show up it would be very useful to have just 13 a very short explanation about what that 14 means. I think there's some confusion about 15 fusion. 16 This is, I think, a question as 17 well, looking at the analyses of the W126 18 Standard, I wonder what other comparisons 19 might be made beyond looking at, you know, 20 just occurrence. 21 So, it's kind of a question for 22 you all. What source of analyses would be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 166 1 useful to inform a policy decision about the 2 form of this standard? 3 So, I don't know the answer to 4 that, but this chapter brought up that 5 question for me. Again, there was a lack of 6 focus on the agricultural symptoms. We just

7 talked about that. 8 And as with our conversation 9 yesterday, that at some point we'll have to 10 deal again with looking at sensitive species 11 versus lumping species together. 12 So in general, it wasn't clear to 13 me what this added beyond Chapter 5, or some 14 combination of Chapter 5 and 6 might be a way

15 to move forward. 16 CHAIR SAMET: Okay. Peter? 17 DR. WOODBURY: Well, there are 18 definitely some continuing themes here. I 19 think this chapter's useful and well-written 20 and appropriate, but the narrow focus on Class 21 1 areas is not appropriate. 22 So, again, expanding the Risk

### 202-234-4433 Neal R. Gross & Co., Inc. Page 167 1 Assessment to include effects on yields of 2 sensitive crops in areas with higher ozone is 3 needed to reflect literally decades of vary 4 solid science. 5 Question 2, about the qualitative 6 discussion, I think most of my comments here 7 echo similar comments that I made yesterday 8 for the Welfare Assessment, so I don't think 9 I have anything additional add, except to 10 refer my written comments here and what I 11 presented yesterday. 12 For Question 3, certainly this 13 Chapter is useful and should be retained. And 14 again, we've talked about, you know, this, the 15 policy document needs to be understandable on 16 its own with, obviously, with reference to 17 supporting information elsewhere. 18 So just to elaborate slightly on 19 that, I think presenting the main conclusions 20 of the supporting document here, and then 21 again, I don't think, you know, how much of 22 the supporting evidence needs to be here.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 168 1 I'm not sure there needs to be a 2 lot of discussion of individual studies, even 3 if they're new here. I think the summary 4 statements that are made in the supporting 5 documents need to be brought forward. 6 And I guess, as far as the 7 quadratic rollback or any other approach used 8 to examine the potential for reduces ozone 9 levels, I think it is appropriate to 10 acknowledge that that is -- it's an 11 appropriate approach, and it reflects the real 12 world and the current emissions. 13 But there is the potential for 14 increased emissions due to industrial 15 development or anything else in regions that 16 are currently not exceeding the current 17 standard. And I think some acknowledgment of 18 this potential is important. And I'll stop

19 there. 20 CHAIR SAMET: Okay. Thanks.

21 Dave? 22 DR. GRANTZ: I would only speak to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 169 1 Question 2 in Chapter 6, and I think it's very 2 important to keep this concept to the 3 Ecosystem Services going. And I think that, 4 as a sort of analytical rubric ought to be 5 expanded if anything. 6 So I think, to the extent that you 7 can, well, just link the ecological effects 8 that are discussed through out the document 9 into this framework, I think, is very useful. 10 CHAIR SAMET: Howie? 11 DR. NEUFELD: After the previous 12 speakers, I can't add anything new. I'd just 13 say I agree with what has been said at this 14 point. 15 CHAIR SAMET: Okay. Other -- 16 MS. WEGMAN: Jon, could we take 17 one moment just to respond a little further to 18 Kathy's question about ag?

19 CHAIR SAMET: Sure. 20 DR. MARTIN: I would direct your 21 attention to the last two times we have looked 22 at this secondary standard, both in the final

### 202-234-4433 Neal R. Gross & Co., Inc. Page 170 1 role in 2008, as well as in the proposed 2 consideration. 3 In both cases, both of the 4 Administrators expressing their views on the 5 secondary standard, made it clear that in 6 looking at crop information on impacts on 7 crops, they recognized how heavily managed 8 crops are. 9 And there's discussions in both of 10 those rule-making documents expressing the 11 policy views of both of the Administrators, as 12 to how difficult the heavily managed aspect of 13 agricultural crops makes determining what the 14 impact on crops is from a public welfare 15 perspective. 16 And as a matter of policy, 17 therefore, they both felt that it was 18 appropriate to focus the secondary standard on 19 other aspects of environmental impacts, other 20 than managed agricultural crops. 21 So when Vicki gave the answer that 22 it was a policy decision, that's what she was

### 202-234-4433 Neal R. Gross & Co., Inc. Page 171 1 eluding to. There's no question that the 2 fundamental science that exists over the 3 decades on crops, that has led to and help 4 support everything we know about other types 5 of vegetation, is clearly important from a 6 science perspective. 7 And I think we could clearly add 8 more of that to Chapter 5. But, to the extent 9 Chapter 7 is intended to take into account the 10 policy perspective that we are left with as a 11 follow on to past decisions, we would then be 12 adding information into 5, that wasn't going 13 to be particularly policy relevant when we got 14 to Chapter 7. 15 And that's the dilemma we find 16 ourselves in, not to disregard the importance 17 of that science, but along the lines that you 18 all are saying, let's make sure what we 19 include in 5 or in 2, on the case of health, 20 is directly relevant to the policy aspects 21 we're going to be discussing in the later 22 chapters. We really have a conundrum in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 172 1 dealing with the crop information.

2 DR. NEUFELD: I'd have to take 3 exception to that, because you're implying 4 that the management is eliminating the 5 problem, right? And that's not true. 6 DR. MARTIN: I'm stating the 7 rationales that have been presented as the 8 basis for the final and proposed decisions 9 that the last two Administrators have 10 presented. 11 DR. NEUFELD: But it's clearly 12 stated in the ISA -- 13 DR. MARTIN: I'm debating the 14 merits of that, I'm just saying that has been 15 the policy view presented. 16 DR. NEUFELD: But it's clear from 17 the ISA, which is the science, that the 18 current agricultural practices today are not 19 preventing crop field losses, either by the 20 planting of resistant varieties, or by the 21 actual agricultural practices in planting. 22 Because you still get the same

### 202-234-4433 Neal R. Gross & Co., Inc. Page 173 1 yield losses you did today, that you did 20, 2 30 years ago. So the whole basis for 3 excluding it seems unattainable. 4 CHAIR SAMET: Yes. I think what 5 I've, you know -- 6 DR. NEUFELD: And this is despite 7 management. 8 CHAIR SAMET: I think just a 9 comment. I mean, maybe what I'm hearing, let 10 me just summarize this. Is Chapters 5 and 6 11 should not be written in light of what the 12 Administrator has done in the past or might do 13 in the future. 14 I think the call is layout the 15 science, and I think in this case, the concern 16 is that something has been omitted based at 17 this point on the past record and how you18 think that might influence future decision19 making. 20 I think what I'm hearing is that

21 should be -- 22 DR. GRANTZ: Right, and I think

### 202-234-4433 Neal R. Gross & Co., Inc. Page 174 1 it's completely inappropriate to cast actual -

2 -

3 CHAIR SAMET: Yes.

4 DR. GRANTZ: -- what some 5 Administrator may or may not have done in the 6 past for whatever reasons, which we might want 7 to ask about, if we really pursue this, is 8 immaterial to me. 9 We have a science document. We 10 have a risk based on the best available 11 science. And then we have what you folks, you 12 know, advised by us believe would be the best 13 policy options.

14 I don't see that what the 15 Administrator did in the past has anything 16 much bearing on me, it probably does on you,

17 I'm sure. 18 (Laughter.) 19 DR. GRANTZ: But I still think 20 that our role here to be, you know, 21 appropriately executed is to carry that 22 science-based information as far forward in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 175 1 this as we can. 2 DR. MARTIN: I'm not suggesting 3 your comments are inappropriate, I'm 4 suggesting it leaves us with a dilemma, that's 5 all. But we will certainly take your comments 6 into consideration. 7 DR. GRANTZ: Well, our role is to 8 advise you, and I think we are advising you on 9 how to resolve that dilemma.

10 CHAIR SAMET: Peter? 11 MS. WEGMAN: That's fine, and we 12 certainly will add the scientific studies into 13 the Chapters 5 and 6. 14 DR. WOODBURY: Well, there's a big 15 difference here between Chapter 5 and 6. 16 Chapter 5, I'm not hearing any reason why we 17 can't all agree that Chapter 5 should 18 adequately cover the science that's been done. 19 And there's plenty of it. It's 20 been well-summarized in previous documents. 21 And these documents do a fine job of bringing 22 in the new information and demonstrating how

### 202-234-4433 Neal R. Gross & Co., Inc. Page 176 1 it confirms older results. 2 I think the more critical, or more 3 challenging question is, what will you do in 4 the Risk Assessment? And I think there is a 5 very strong scientific basis for assessing 6 risks of crop yield loss for sensitive crop 7 species throughout many parts of the country. 8 The scientific data are very 9 strong, because we've been able to do 10 experiences that actually measure yield loss 11 in the fields. 12 And those of you who are familiar 13 with this, you know, I don't need to emphasize 14 this, but it's, you know, we're actually 15 measuring in the field under realistic field 16 conditions, yield losses. We're not 17 extrapolating, we're measuring a real effect. 18 There's some discussion of whether 19 a ten percent yield loss has been suggested as 20 a cutoff value. I would suggest that a five 21 percent yield loss is extremely economically 22 important.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 177 1 It's difficult to measure in an 2 individual field, but it's not difficult to 3 make robust predictions for many fields across 4 a county or state, given the good information 5 we have about ozone exposure and the good 6 information we have about exposure response 7 functions. 8 I spent quite a bit of time in my 9 comments yesterday explaining why, in my view, 10 it's useful to look at a sectoral wide 11 approach to crop yield loss, but it's 12 inadequate simply to do that. 13 Because, I think there's very 14 strong scientific evidence of crop yield loss 15 for sensitive species over large parts of the 16 country. And I think that's a welfare impact, 17 in my view. 18 So I think, anyone's allowed to 19 say anything they like about something being 20 a policy judgment, but as scientists, I think,21 we also need to say what we think is well22 supported by the scientific evidence. And you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 178 1 have to decide whether you want to ignore the 2 scientific evidence. 3 CHAIR SAMET: Well, I think the 4 word is not ignore, I think the question is 5 actually how it figures into the policy 6 judgment at the end. But I think the message 7 should be very clear by now that it should be 8 included. I think that was -- 9 DR. WOODBURY: Let me clarify the 10 word ignore. I think leaving out assessment 11 of crop yield loss for areas, for sensitive 12 crops in areas with elevated ozone, leaving 13 that out of the Risk Assessment would be 14 ignoring the science, in my view. 15 CHAIR SAMET: All right. So I 16 think the call is to include it. Let's see, 17 anything else on this point, because we still 18 have one more chapter to get through on this, 19 on Chapter 6. 20 (No response.) 21 CHAIR SAMET: Okay. And actually, 22 Peter, would you be the summarizer for this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 179 1 one, Chapter 6? 2 (No response.) 3 CHAIR SAMET: Thank you. So, 4 Chapter 7, Kathy. 5 DR. WEATHERS: Okay, so Chapter 7, 6 I have just a couple of comments, obviously, 7 since this is the first draft and there are 8 many analyses left to do. There are extensive

9 comments. 10 One is, that it's clear that 11 you'll have to deal with a western anomaly 12 that was talked about yesterday, in terms of

13 the ozone surfaces. 14 And the other question that I had, 15 I think this is a fairly well laid out chapter 16 to the extent that it's complete. It has to 17 do with the use of case studies again and the 18 Class 1 wilderness areas. 19 Many of them, as we said 20 yesterday, are high elevation. The diurnal 21 part of the standard, when you're looking at 22 12 hours, and you're not looking at night time

### 202-234-4433 Neal R. Gross & Co., Inc. Page 180 1 ozone may turn out to be a challenge. 2 It's one of the few places where 3 it actually may matter that ozone is looked at 4 through a 24-hour period rather than a 12-hour

5 standard. 6 So once again, it's just a 7 question to you about focusing on these areas 8 and what kinds of challenges may provide in 9 terms of thinking about the PA. 10 CHAIR SAMET: Okay. Peter? 11 DR. WOODBURY: Well, this is the 12 summary in conclusions chapter. I think it's 13 a bit premature for us to be commenting on 14 this. 15 So, I did provide responses to the 16 questions and some detailed comments, but 17 basically, they reflect my previous comments 18 on the need for augmenting the Risk Analyses 19 and then the subsequent discussion, obviously, 20 the synthesis would then include that 21 information as well. 22 CHAIR SAMET: Okay. Howie?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 181 1 DR. NEUFELD: And just to build on 2 the comments from the others, that generally 3 it's a well-written chapter. The justification 4 for switching away again, I'm going to 5 emphasize it again, from the eight hour index 6 to the cumulative weighted index is based on 7 strong evidence in the ISA, and also in the8 Welfare REA. So, I just wanted to re9 emphasize that. 10 With regard to Question 2, I think 11 this does a good job of justifying the range 12 of levels that you were proposing for the 13 secondary standard. 14 And there were concise summaries 15 and conclusions there, you could read that 16 fairly easily. But I will again, emphasize 17 that if you're going to propose a secondary 18 standard and not consider half of the data, 19 and some of it the strongest data, is just an, 20 I don't want to use too strong a word, 21 abrogation of your responsibilities to 22 consider all of the evidence.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 182 1 CHAIR SAMET: Okay. Dave? 2 DR. GRANTZ: Well, I can't add 3 much to that, but I agree. I thought that 4 this chapter was pretty nicely laid out, 5 actually. I liked it. 6 I thought it did a good job of 7 looking at the form and the averaging period. 8 But I thought when it got to 7.3.3, I guess I 9 disagree a little bit with Howie, I didn't get 10 a feel really for the levels that were being 11 recommended or why. 12 So I thought that, since that's 13 kind of the key issue, one of the key issues 14 anyway, that that needed to be beefed up a 15 little bit. And then in my written comments 16 I mentioned again this business of 17 agricultural data.

18 CHAIR SAMET: Peter. 19 DR. WOODBURY: Just pull out -- 20 I'd like to just pull out one comment that I 21 made and elaborate on that a little bit from 22 my written comments.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 183 1 I mentioned recommending 2 consideration of a five percent yield loss 3 level for crops that over a wide area, not an 4 individual field. 5 And for a tree species, you know, 6 one to two percent yield loss doesn't sound 7 like much. The focus here is on two percent. 8 If you go back to the document, 9 the so-called consensus, or meeting document 10 that was cited, it actually says one to two 11 percent. That's a large difference, actually. 12 And this doesn't sound like much, 13 one or two percent, but we're talking about 14 perennial plants, so if you do, Howie just did 15 a nice compounding exercise. You can do this 16 yourself on the Web, from any number of 17 compounding tools. 18 And that that kind of a growth 19 decrease compounds very quickly for a plant 20 that might live for 100 years. So, I think, 21 making sure to include that kind of 22 compounding example will help indicate why,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 184 1 you know, something that looks only like one 2 or two percent is actually much, much more 3 substantial than that. 4 And in addition, there can be the 5 subsequent impacts that there are effects on 6 competition as well. That would be an 7 additional separate type of additional effect. 8 CHAIR SAMET: Thanks. Okay, 9 Howie? 10 DR. NEUFELD: Just to emphasize, a 11 one percent loss over 75 years is more than a 12 50 percent growth loss over that 75-year 13 period. So it can, it's really a small 14 difference over a large period, long time. 15 CHAIR SAMET: Okay. And, Howie, 16 would you be the summarizer? I think that 17 will lead to an equitable distribution of the 18 summarizing goal. 19 DR. NEUFELD: I keep getting 20 Chapter 7 -- 21 CHAIR SAMET: And if you don't 22 want to do it, get Sverre to do it. But --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 185 1 (Laughter)

2 CHAIR SAMET: Other comments on 3 Chapter 7? There's just a few other things 4 I'd like to move on to, and I think we still 5 have one person, who wants to make clarifying 6 comments. So Chapter 7, Chris. 7 (Off microphone comment). 8 CHAIR SAMET: Okay. Okay. So, I 9 did say we would actually go back to Chapter 10 4, so let's see, are there comments to Chapter 11 4, let's do that real quick. 12 DR. FREY: Yes, I just, I, you 13 know, one of the charge questions is, what 14 range of alternative ozone levels would be 15 appropriate for further exposure and risk 16 analyses in the second draft. 17 This is a question on the Policy 18 Assessment, but it's asking what would be a 19 good, good levels for the REA Second Draft 20 that would inform the second Policy

21 Assessment. 22 I don't feel like, as a Panel,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 186 1 we've really answered that. I know we had a 2 couple of people comment on it. But it just 3 seems like an important point we ought to give

4 EPA the Panel feedback on. 5 CHAIR SAMET: Okay. I guess the 6 discussion that we've had is largely been in 7 a sense, I mean, there are some fairly obvious 8 points of concentration to consider. I guess, 9 probably the more most important question is 10 will there be a recommendation to go below 60 11 ppb, is that not correct? 12 So, I think that there's lots of 13 numbers from 60 to 75 that you know, and can 14 pick. But it seems to be the more critical 15 question is probably this question of whether 16 we would recommend considering scenarios below 17 60 ppb. 18 And I think we heard differing, 19 somewhat differing views on that at least from 20 you, and possibly others, if I remember right, 21 about numbers like 55 versus, Fred, who 22 suggested stopping at, I think, not going

### 202-234-4433 Neal R. Gross & Co., Inc. Page 187 1 below 60.

2 And then we have others who would 3 like to comment on this point of guidance.

4 Sverre? 5 DR. VEDAL: Just as a precedent, 6 we were at a time when we had the lung 7 function data, which showed effects at 80. 8 And it was argued, because we were seeing 9 effects at 80, that we should go below that. 10 We're now in a situation where we 11 see effects at 60. So in parallel and 12 symmetry, one could make an argument, that if 13 we're seeing effects at 60, we should consider 14 looking at considering a standard of 50. 15 CHAIR SAMET: I mean, these are 16 analyses to essentially inform the 17 Administrator and judgment when they go back 18 to the PA. I mean, they're not, these are 19 not, I guess, bright lines defining what a 20 standard might be. These are scenarios for 21 analyses, and I think we need to remember

22 that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 188 1 So I don't know that we have a 2 Panel view about this, and I don't 3 particularly want to take a vote, but let me 4 just get a sense of how others feel about 5 really whether some of the analyses should 6 extend below 60, and probably 55 seems like at 7 least one point that might be considered. Ed, 8 is that a yes?

9 DR. AVOL: Yes. 10 CHAIR SAMET: That's a yes. 11 Anyone else want to venture into this 12 territory? 13 (No response.) 14 CHAIR SAMET: Okay. I think you 15 just had a weak opinion from us. But I, I 16 mean, at least, to me, it does not seem 17 unreasonable to consider 55 is going to be 18 useful for, really in forming the analyses. 19 I mean, again, I don't think this 20 is a commitment to anything, except some 21 scenarios to explore to try and understand 22 where risk gets generated and that total risk.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 189 1 Fred, do you have, you want to -- 2 DR. MILLER: Yes, I guess, I just 3 don't think that the overall weight of the 4 evidence going beyond the FEV1 changes support 5 it. 6 But, given that, at this point in 7 time, you could go to 55 parts per billion. 8 But it's like, to me, it's the last thing you 9 do to add into the document, because all the 10 other things we've discussed in terms of 11 priority of what you ought to be doing for 12 this next go around. 13 If you still have time, then I 14 might look at some of that, but I think it's 15 extremely unlikely to be able to really shed 16 enough light that that would be a value in the 17 final interval that we might recommend. 18 CHAIR SAMET: Okay. Before the 19 room empties, and we still have one person on 20 the phone to hear from. I think one issue, 21 and perhaps this will have to come up in our 22 follow-up phone calls. And perhaps, one that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 190 1 more pertains to the charter CASAC than the 2 panel in full is, some discussion of sort of 3 the process that is playing out now around 4 sort of what I'll call incremental and 5 evolutionary review of documents. 6 Clearly, I think, in our view, the 7 Third Draft ISA is done. I would hope that 8 there's not a need, on the part of any of us, 9 I assume, that we would ever want to see the 10 Fourth Draft ISA brought to us for formal 11 discussion. 12 So that's done. Okay, but with 13 the REA about to, and probably particularly 14 the REA, you know, it seems like we're acting 15 in sort of a let's say an advisory or 16 consultant role as some key decisions are 17 being made in sort of what seems to be a 18 sequential process of development, 19 essentially, the machinery of the REA. 20 And maybe, and that's just fine, 21 I mean, the purpose of CASAC is to advise, but 22 this is somewhat different from some of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 191 1 approaches of the past when, and particularly 2 since we now have the REA in a sense rather 3 than sort of the CD and the staff paper, that 4 you are doing a lot of work that takes time to 5 accomplish as you move forward there are 6 decisions to be made. 7 You're clearly not bringing a 8 completely done REA to the Committee, rather 9 we're seeing it in pieces, giving guidance and 10 sort of bringing Template 1, Template 2, and 11 so on, and getting guidance. 12 I think this makes for a different 13 kind of review, because what we're looking at 14 is always moving, and you know, we're seeing 15 it at different stages. 16 And again, I think that this needs 17 some discussion on, I think, how the process 18 will work, at what point CASAC appropriately 19 comments. And, in particular, how we in the 20 end get a look at the final product and make 21 sure that the final product is right. 22 And, you know, I think we had the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 192 1 discussion on Tuesday about the schedule that 2 was put before us, that had one more CASAC 3 meeting on the entire set of documents. And 4 when, I'm remembering correctly. 5 And I think the single Spring 6 meeting, this really seems unlikely to be 7 satisfactory, in terms of either where you 8 are, or allowing CASAC to provide the review 9 that it needs to. Especially since, you know, 10 again, as I said, we're seeing a product in 11 development. 12 So, you know, among other things 13 you might want to think about what a realistic 14 time frame is. I know you have deadlines that 15 come from elsewhere, and you want to do the 16 best job possible and try and meet those 17 deadlines, as there may be some problems now 18 with the amount of time available, what you 19 have to do. And what do you have to do and 20 bring to CASAC to have reviews. 21 So I think this is a topic that 22 merits being highlighted, perhaps in our

### 202-234-4433 Neal R. Gross & Co., Inc. Page 193 1 letter on the REAs. And perhaps, if we meet 2 by phone will be something that we should 3 discuss. 4 And, you know, I think I 5 understand exactly why we're having these 6 interactions as they are, but I think we 7 should acknowledge that and then look and 8 consider implications. 9 So I don't think we have time to 10 go into this further, but I think this is an 11 important enough issue that it merits some, 12 you know, full discussion. That's, yes, Fred. 13 DR. MILLER: Jon, would you 14 anticipate that the two pages we reviewed and 15 gave our high low and that would be 16 incorporated in our response to this review, 17 and that sort of really helps them jumpstart, 18 you know, their allocation and resources and 19 time in that, so -- 20 CHAIR SAMET: Right.

21 DR. MILLER: That could be 22 formalized, you know --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 194 1 CHAIR SAMET: Right. Right. No, 2 actually, I think this should be an appendix, 3 or something, to our letter. But, I mean, 4 it's a good example of exactly what I was 5 talking about and our sort of engagement, 6 involvement in this ongoing process. 7 So I'm not sure we, you know, just 8 highlight this issue for further discussion 9 while we're here together. Let me ask, I 10 think we do have one person on the phone for -

11 - 12 DR. NUGENT: Actually, he's here 13 in the room. 14 CHAIR SAMET: Oh. Here in the

15 room. 16 DR. NUGENT: And I wonder if you 17 could -- if he could speak to -- 18 CHAIR SAMET: Mr. Ted Steichen, 19 who's going to make clarifying comments, which 20 you have for three minutes.

21 MR. STEICHEN: Yes. Thanks to 22 those of you from the Panel that were able to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 195 1 stay for this last comment. And I think Dr. 2 Samet was just speaking about what I was 3 interesting in making a clarifying comment 4 about, which dealt with the schedule. 5 And again, I think it's very 6 important to recognize, I think, as Dr. Martin 7 went through, is a history that often CASAC 8 has come into play as it relates to issues in

9 the court. 10 And since there may very well be 11 an activity soon in the court, in terms of 12 trying to speed up the review of ozone to make 13 the five-year schedule. 14 If, in your letter, you identified 15 the need for you to get your work done 16 required a certain amount of time, that may 17 weigh into the time the Administrator would be 18 able to provide that as additional information 19 to the court to explain why perhaps this 20 process needs to take longer. 21 You know, it's very clear, as an 22 observer, I've certainly been watching these

### 202-234-4433 Neal R. Gross & Co., Inc. Page 196 1 meetings for the last five years myself. API 2 has been involved in it from the beginning. 3 We have always seen a tremendous 4 amount of public service by the part of CASAC, 5 and certainly professionalism on the part of

6 the EPA Staff. 7 So I'm sure it's very 8 disheartening to have to make comments like 9 chapters aren't very well written. And we 10 know it's probably not very nice to get those 11 comments either. 12 So there's something about the 13 process that needs to change to be able to 14 allow qualified people to get work done in a 15 qualified way. So that was that comment. 16 And then the last one was, I asked 17 Dr. Nugent to hand out the first page of the 18 Charter for CASAC again. And I just wanted to 19 hit on Number D, which references the fact 20 that you are chartered to identify 21 anthropogenic and natural emission sources. 22 So that's an important role for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 197 1 you. And, again, you may have a role beyond 2 simply responding to the charge questions that 3 you received from the Administrator. 4 Your charge came from a Congress. 5 And you also have a Charge E here, where 6 you're to look at the impacts of different 7 approaches to attain these standards. 8 And again, if there was an 9 investigation of the work that's going on with 10 CASAC, I don't think there would be a lot of 11 evidence, right now, that these issues have

12 been worked. 13 So, again, I would just ask Dr. 14 Samet, in his final letter to the 15 Administrator, to perhaps point out how all of 16 these charter requirements are handled, and 17 also to look at the schedule for this current 18 ozone review. Thank you. 19 CHAIR SAMET: Okay. Thank you. 20 Any questions or comments? 21 DR. GRANTZ: I didn't, in the 22 introduction, I didn't catch for whom.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 198 1 MR. STEICHEN: Yes, that's my 2 question. 3 DR. GRANTZ: Who are you speaking

4 for? 5 MR. STEICHEN: I'm Ted Steichen, 6 I'm with the American Petroleum Institute. 7 DR. GRANTZ: Thank you. 8 CHAIR SAMET: Okay. Thank you. 9 Let's see, we are down in numbers. The 10 stalwarts are here. Anything else that we 11 need to do? I don't think so. So, Angela, 12 any, or Vanessa, any last minute instructions? 13 So, rapid turnaround on your 14 summaries. There will be a conference call, 15 probably at least one conference call, and 16 we'll see what else may be necessary. And a 17 meeting this Spring comes to North Carolina. 18 DR. NUGENT: Right. And, Vanessa, 19 do you have anything to add? 20 (No response.)

21 DR. NUGENT: No? 22 DR. VU: I just want to thank the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 199 1 members of the Ozone Review Panel for your 2 hard work and provide very useful advice to 3 the Agency, very much appreciate your time 4 being here the last three days. And, of 5 course, once again, I just want to extend our 6 sincere thanks to our Chair, Dr. Jon Samet. 7 I know, I think Dr. Samet asked me 8 earlier about how many letters are there, so 9 I just want to remind you that the Agency 10 requests you to review the ISA. That is the 11 ISA's Paper Office and Research Development, 12 so we'll have a separate letter to go to ORD. 13 And then the REAs, the two reports 14 in the REAs, one separate letter and the PA is 15 the last letter. So you actually have three

16 letters. 17 And you will receive a follow-up 18 email from Angela and Aaron Yeow. Aaron will 19 be the DFO to put all the reports together. 20 Even though Aaron is not here 21 today, but he's been listening on the phone 22 and working closely with Angela to develop

### 202-234-4433 Neal R. Gross & Co., Inc. Page 200 1 that. And with that, I want to thank you 2 again, and have a safe journey home. 3 CHAIR SAMET: Okay. And thanks, 4 and good luck. 5 DR. NUGENT: Right. So we're all 6 adjourned. 7 CHAIR SAMET: Adjourned. 8 (Whereupon, the above-entitled 9 matter went off the record at 11:50 a.m.)

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187:7,9 84 3:10 89 3:11 9 90 76:2 133:1 91 3:12 93 3:13 96 3:14 97 14:15 99 3:14NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com C E R T I F I C A T E

This is to certify that the foregoing transcript

In the matter of:

Before:

Date:

Place:

was duly recorded and accurately transcribed under my direction; further, that said transcript is a true and accurate record of the proceedings.

----------------------- Court Reporter 228

Clean Air Scientific Advisory Committee Ozone Review Panel

US EPA

09-13-12

Raleigh, NC