### 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

+ + + + + FRIDAY, MAY 20, 2011 + + + + + The meeting convened in the Chancellor's Ballroom of the Carolina Inn, 211 Pittsboro Street, Chapel Hill, North Carolina, at 8:30 a.m., H. Christopher Frey, presiding. CASAC MEMBERS PRESENT: H. CHRISTOPHER FREY JONATHAN M. SAMET, CHAIR* GEORGE A. ALLEN

JOSEPH D. BRAIN ARMISTEAD (TED) RUSSELL HELEN SUH KATHLEEN WEATHERS* PANEL MEMBERS PRESENT: ED AVOL

JOHN BAILAR MICHELLE BELL DAVID CHOCK WILLIAM MICHAEL FOSTER JUDITH GRAHAM DAVID GRANTZ JACK HARKEMA

DANIEL JACOB STEVEN KLEEBERGER FREDERICK J. MILLER

### 202-234-4433 Neal R. Gross & Co., Inc. Page 2

HOWARD NEUFELD

JAMES ULTMAN

SVERRE VEDAL*

PETER WOODBURY

SCIENCE ADVISORY BOARD STAFF:

HOLLY STALLWORTH, DESIGNATED FEDERAL OFFICER

*Participating via telephone

### 202-234-4433 Neal R. Gross & Co., Inc. Page 3

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

Presentation on Scope and Methods Plan for Health Risk Assessment 8

Public comment 60

Exposure Analysis Issues 77

Health Risk Assessment Issues 121

Presentation on Scope and Methods Plan for

Health Risk Assessment 198

Air Quality Considerations 244

Ecological Effects, Ecosystem Services 264

Adjournment

### 202-234-4433 Neal R. Gross & Co., Inc. Page 4 1 P-R-O-C-E-E-D-I-N-G-S 2 (8:35 a.m.) 3 DR. FREY: Okay, let's come to 4 order. Good morning. I am one of the 5 mysterious voices on the phone from yesterday. 6 My name is Chris Frey, and I'm a member of the 7 panel. I wasn't able to be here in person 8 yesterday, but I was on the phone. And John 9 is not able to be here today, and -- John 10 Samet, you're on the phone? Or maybe not yet. 11 So we've traded places.

12 DR. SAMET: I'm here. I'm here. 13 DR. FREY: Oh, good.

14 DR. SAMET: Yes. 15 DR. FREY: Okay, welcome. So, the 16 purpose of today is to do what is called a 17 consultation on the scope and methods plan for 18 the health risk and exposure assessment, and 19 the scope and methods plan for the welfare 20 risk and exposure assessment. 21 A consultation is a little bit 22 different than a review. So, yesterday, you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 5 1 had lead discussants, and the lead discussants 2 are -- have the responsibility to develop a 3 consensus statement and response to a charge 4 question, and we'll be working with Dr. Samet 5 to develop a consensus letter that we as a 6 panel will review through teleconference in a

7 few weeks. 8 In contrast, with a consultation, 9 we're not obligated nor required to reach a 10 consensus. There will be a very brief letter 11 to the administrator that simply states that 12 we held a consultation today on these two 13 scope and methods plans, and the letters will 14 have an attachment of the individual member

15 comments. 16 So, anything you would like to 17 convey in writing to the US EPA, you will need 18 to do so under your name as your individual 19 written comments. And if there's something 20 that you hear in the discussion today that you 21 agree with, if you want to communicate that to 22 EPA, you should do that in your written

### 202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 comments. And likewise, if there's something 2 you would like to take issue with, you would 3 need to do that in your own comments. 4 So, we're not going to try to 5 reach a consensus on each issue. What we will 6 do today is EPA will make a presentation on 7 the -- first the scope and methods plan for 8 the health risk and exposure assessments, and 9 then we will have member comments on the 10 exposure and health risk analysis issues 11 regarding that scope and methods plan. 12 Once we get through that, then EPA 13 will present on the welfare scope and methods 14 plan, and then we will have individual

15 comments. 16 Now, there are identified 17 discussants for each of these scope and 18 methods plans. I will call in those people 19 first. But any Panel Member will have an 20 opportunity to provide comments during the 21 discussion today. And as I said earlier, I 22 would encourage you as we go through the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 7 1 discussion to think about either revising your 2 written comments, or if you haven't submitted 3 written comments, think about what you might 4 want to submit in writing, and I'm sure Holly 5 will work with us to set a deadline for when 6 those should be submitted. 7 Any other procedural points, 8 Holly? Okay. Any questions on what's meant 9 by a consultation? Okay, good. All right, 10 so, with that, I would like to invite the US 11 EPA to please go ahead and present to us on 12 the scope and methods plan for the health risk

13 assessment. 14 MS. WEGMAN: Good morning. This 15 is Lydia Wegman again. Thank you all for 16 returning, and again, thank you all for your 17 work yesterday. 18 My team here is going to be 19 presenting in a moment. I'll just quickly 20 introduce folks, and then I want to just say 21 a couple of words about resources before I 22 turn it over to this team of ours, which has

### 202-234-4433 Neal R. Gross & Co., Inc. Page 8 1 done a great job in my view on the scope and 2 methods plan. 3 This is Dr. Zach Pekar. Dr. Bryan 4 Hubbell is sitting back here. He's been 5 leading the team, Dr. John Langstaff and Dr. 6 Travis Smith, and they will be key presenters 7 today on the scope and methods plan. 8 Before I take a seat in the back, 9 there were some comments yesterday, and there 10 have been comments throughout, expressing 11 concerns about resources, and the points we've 12 made in the scope and methods plan about

13 resources. 14 I just want to let you all know 15 that I think from reading the newspapers you 16 all know that it is a time of shrinking 17 resources for the federal government, and 18 especially for EPA. And in putting what we 19 put into the plan, we wanted to alert you that 20 what we are putting together may be 21 constrained by the resources that are 22 available to do the analyses that we are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 9 1 setting out. 2 We are trying to do as much work 3 in-house as we are able to, to minimize the 4 need for additional contract dollars, and we 5 do have really a team of outstanding folks who 6 will do as much work in-house as we can. But 7 -- and we want to do as much of the analyses 8 as we can, but part of what we're asking for 9 your advice on is how to prioritize the 10 different tasks that we've laid out. Because 11 if we do have limited resources, we want to 12 know what you view as the most important 13 things to do with those resources. 14 So, it's not that we want to limit 15 our work; it's that we realize we may be 16 limited by the amount of money available to 17 us. And so, that's the advice we're seeing 18 from you. Okay, thank you. 19 MR. LANGSTAFF: Okay, so Zach and 20 I are presenting the overview of the plan for 21 the Ozone Health Assessment; the purpose of 22 the plan and this meeting is to get feedback

### 202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 on the methods we're proposing for assessing 2 risk under different air quality scenarios. 3 I'll be talking about the exposure modeling, 4 and the risk assessment based on clinical 5 studies and Zach will cover the risk 6 assessment based on epi studies. 7 In the last review, we estimated 8 exposure and risk for the general population, 9 children and asthmatic children for different 10 air quality scenarios. 11 We did this for 12 cities across 12 the US. In this review, we might only be able 13 to do this for three cities. We planned on 14 using the most recent three-year period for 15 air quality with complete data for this 16 analysis, and we'll be using the quadratic 17 rollback approach to adjust the distribution 18 of hourly ozone concentrations to reflect 19 attainment of the current standard and 20 alternative standards. 21 The last review we took into 22 account policy relevant background. In this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 11 1 review, we're not really even using that term. 2 We're going to put a focus on contributions 3 from natural background and international 4 transport in more detail. And to be able to 5 do this, we have four global simulations of 6 those being done using the GEOS-Chem model, 7 and one is natural background, where there is 8 no anthropogenic emissions anywhere globally; 9 one where you have only anthropogenic 10 emissions outside North America, but the 11 emissions in North America are set to zero; a 12 third where the emissions in the US, 13 anthropogenic emissions, are set to zero, and 14 a fourth with current conditions. 15 And we'll be taking into account 16 the anthropogenic methane emissions 17 appropriately. Some runs to use it for the 18 same value for those for the different 19 scenarios, but we're factoring that in 20 properly. 21 The APEX model estimates the 22 distribution of exposures of the population.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 12 1 It does this by simulating many individuals. 2 It uses a database of diaries to mock the 3 locations and activities of individuals and 4 calculates their exposures while they're doing 5 different activities in different 6 microenvironments. 7 A physiological model estimates 8 their ventilation rates, and combining that 9 with their exposures, the lung function effect 10 is estimated. 11 We'll be analyzing five groups, 12 five population groups: the general 13 population, school-aged children, asthmatic 14 school-aged children, outdoor workers, and 15 elderly. In the last review, we did not look 16 at outdoor workers, although we did it in the 17 review prior to that, and this is the first 18 time we're breaking out the elderly as a 19 separate group. 20 So, we'll be -- some new analyses 21 we'll be doing: one is doing our analysis of 22 the different conditions that are associated

### 202-234-4433 Neal R. Gross & Co., Inc. Page 13 1 with high exposures and risk, hot blazing 2 attributes, activities, microenvironments, 3 locations and things like that. 4 We'll be estimating fractional 5 contributions to exposure and risk from 6 international and national sources, using 7 those four GEOS-Chem runs to do that. This is 8 not straightforward because nonlinearities of 9 ozone formation and that -- the response of 10 ozone to changes in emissions will depend on 11 the levels of other pollutants. 12 And so, you can actually have 13 situations where your emissions are reduced, 14 but your ozone increases. So, it's not a 15 straightforward problem to estimate these 16 fractional contributions. And we'll be doing 17 a qualitative analysis of the effect of the 18 air quality index on people's behavior and how 19 that affects their exposures. 20 So, we'll be modeling both 21 variability and uncertainty of exposure and 22 risk, and variability is built into the APEX

### 202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 model. The results of each model run reflect 2 this variability, and the results of the model 3 are given as distributions of exposures, 4 population distributions, and the types of 5 variability of the model are population 6 demographics, which we have at each census 7 tract, the physiology of individuals, ozone 8 concentrations, which vary by hour and then 9 across space, activity patterns, and then the 10 variables that go into calculating indoor 11 concentrations and indoor exposure, such as 12 air exchange rates, ozone decay and deposition 13 rates, penetration factors and air 14 conditioning. 15 In order to estimate uncertainty, 16 we're using a two-dimensional Monte Carlo 17 approach, as we did in the last review. This 18 time, we'll be extending the quantitative 19 assessment of uncertainty to include the lung 20 function risk estimates. 21 So, this risk assessment looks at 22 lung function in terms of FEV1 decrements

### 202-234-4433 Neal R. Gross & Co., Inc. Page 15 1 greater than 10, 15 and 20 percent, and the 2 policy assessment will address the public 3 health significance of these particular cut 4 points. And the last review, population level 5 exposure response functions were combined with 6 the distributions from APEX to give us these - 7 - the risk lung function. 8 In this review, we're using 9 improved model based on work by McDonnell, 10 Stewart and Smith, that allows to estimate the 11 lung function decrements for individuals in

12 the APEX model. We'll use the old method 13 also, so we can compare the results of the

14 two. 15 In both of these methods, the 16 exposure response relationships are derived 17 from clinical studies. So, the new model 18 allows us to estimate lung function decrements 19 for each simulated individual, and should 20 result in more accurate estimates of risk for 21 this end point. 22 It predicts changes in FEV1 based

### 202-234-4433 Neal R. Gross & Co., Inc. Page 16 1 on individuals' physiology and time varying 2 ventilation rates and ozone exposures, which 3 APEX estimates for every minute for each 4 individual, and a person's changes in FEV1 at 5 a given time depend on the values of these for 6 the previous few hours. 7 The authors fit the model using 8 data from several clinical studies, where the 9 ages range from 16 to 35, and ozone exposures 10 were between 80 and 400 ppb. We are -- we 11 planned to obtain data from other additional 12 studies that have lower lowest ozone, and 13 hopefully children. Otherwise, it's going to 14 be problematic to extend this to children.

15 We have data from a recent EPA 16 study by Kim and others, that have exposure at 17 60 ppb and there are other studies out there 18 that have exposures at 40 ppb. 19 Once we obtain all this data, we 20 will refit the model using that data to get a 21 better handle on the range of exposures, and 22 we'll be able to do a quantitative analysis of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 17 1 the uncertainty of these risk assessments. 2 And now, I'll turn it over to Zach. 3 DR. FREY: Maybe while we're 4 waiting, are there any clarifying questions 5 for John Langstaff? I see Ted and Ed. 6 DR. RUSSELL: Couple questions. 7 So, you're going to be using APEX. And is 8 that going to be done in-house or out of

9 house? 10 MR. LANGSTAFF: That's being done 11 in-house. 12 DR. RUSSELL: That will be done 13 in-house?

14 MR. LANGSTAFF: Yes. 15 DR. RUSSELL: Because that depends 16 how many possible cities you can do. 17 MR. LANGSTAFF: Right, correct.

18 DR. RUSSELL: The second. You 19 said you're going to -- you treat methane 20 properly in your slides, but when I read the 21 document, it was very unclear what you're 22 going to do with methane and why.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 MR. LANGSTAFF: Right. So, when 2 we wrote the scope and methods plan, we 3 thought that we were going to have to do this 4 adjustment to the model results, but we've -- 5 the model run is now being done with correct 6 methane inputs, and so, we're not going to 7 need to do that adjustment of the model 8 results. That's not to say that the models 9 are correct, but as far as the models, we're -

10 - 11 DR. RUSSELL: Anthropogenic 12 methane emissions specifically? 13 MR. LANGSTAFF: Right. So, we're 14 doing those reductions. Right, appropriately. 15 DR. HUBBELL: And it's understood 16 we're looking at the mixing ratios, rather 17 than trying to take the emissions of methane 18 and zero them out in a particular way, 19 although it would be nice to model that 20 through. But most of the -- and maybe Daniel

21 can talk about that. 22 DR. RUSSELL: So, you're not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 19 1 treating the methane, anthropogenic methane -- 2 directly? 3 MR. LANGSTAFF: Actually -- well, 4 I mean it's in there sort of as a constant 5 concentration across the globe. I mean you 6 can do model runs of the emissions, but since 7 the methane has a long lifetime, you need to 8 model, you know, decades to bring that up to 9 speed. 10 So, we're adjusting the methane 11 concentration that's in the model to reflect 12 these differences in emissions, and it's not 13 exactly straightforward because you can't just 14 say, "there's 20 percent." You're reducing 20 15 percent emissions, so you take 20 percent off 16 that concentration because it's a feedback 17 factor in those other things. 18 So, there's some uncertainty in 19 how we're going to do that, but yes.

20 DR. JACOB: For natural methane 21 concentrations, we use the data from the ice 22 spores. So, we know what the concentration

### 202-234-4433 Neal R. Gross & Co., Inc. Page 20 1 was before human activity. 2 MR. LANGSTAFF: Right. 3 DR. JACOB: So, the natural ozone 4 concentrations, as you decided from GEOS-Chem, 5 uses pre-industrial methane. Now, we also did 6 a run with present day methane and other 7 global anthropogenic sources shut off. So, if 8 we wanted to single out the effect of methane, 9 which is about 5 ppb, we could do it. 10 DR. RUSSELL: So, then just count 11 the North American methane versus -- 12 DR. JACOB: This we haven't done, 13 and as John pointed out, that might be 14 difficult to do. Well, it's very small. I 15 mean the North American anthropogenic 16 emissions are very, very small contribution to 17 the global anthropogenic source of methane, 18 which is largely from livestock and rice 19 paddies and natural gas. 20 MR. LANGSTAFF: Yes, so, we're 21 making our adjustment, but it's not going to

22 have much effect.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 21 1 DR. HUBBELL: Yes, and our plan -- 2 we're considering adding a chapter to this 3 document, to focus on international 4 contributions to ozone and risk. One of the 5 things we've been discussing is the need to 6 separate out methane from other precursors 7 because of the difference in the time it takes 8 for it to fully affect the ozone 9 concentrations, and that's why we're more 10 interested in breaking it out, and not 11 treating it like other international 12 emissions, which would directly affect shorter

13 term ozone. 14 DR. FREY: Okay, Ed, did you have 15 a question? 16 MR. AVOL: Yes, I have a quick 17 question. So, you said you'd use the 2008 to 18 2010 data, and that makes sense because I 19 guess that's the most recent available. But 20 I have a question about how generally 21 representative 2008 to 2010 is in terms of -- 22 MR. LANGSTAFF: Well, those years

### 202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 are generally lower, I guess, than previous 2 years. So, we're going to -- we'll consider 3 doing a couple earlier years, which also for 4 the exposure might be important to match up 5 with the time period of GEOS-Chem runs. 6 That's not so important with the risk because 7 the exposures depend on temperatures, which 8 are related to the ozone. So, it's sort of 9 more important to match up for the model runs 10 for the exposure. The risk doesn't depend on 11 the temperatures. 12 MR. AVOL: Yes, that's what it 13 seems like. I mean however you decide, it 14 seems like it's worth the paragraph or some 15 comment about what you did and why you did it. 16 MR. LANGSTAFF: Right. 17 DR. FREY: Just keeping in mind 18 this is mainly clarification, and we want EPA 19 to finish their presentation. Then we can do 20 the consultation. But are there other 21 clarifying questions? Fred. 22 DR. MILLER: Can you, as you go,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 23 1 identify what's going to be in-house and 2 what's going to be out house? Because I am 3 already prioritizing based on your 4 presentation. There are several things that 5 I want you not to do because they're a waste 6 of time. Is that okay? 7 MR. LANGSTAFF: Okay, well,

8 that'll be useful. 9 DR. MILLER: And yet I don't know; 10 it might be something that is a trivial thing 11 to extend, or it may be that it costs you big 12 bucks to go outside. So, as you're describing 13 these things, could you please kind of give us 14 a sense of where the responsibility will lie?15 MR. LANGSTAFF: Yes. It's all in16 house. 17 DR. MILLER: Oh, Lydia. Were you 18 politicking for money? What do you mean

19 there? 20 DR. HUBBELL: To be clear on that, 21 what John is saying is it's all in-house right 22 now, but some of the things that we've

### 202-234-4433 Neal R. Gross & Co., Inc. Page 24 1 identified as uncertainties, other things that 2 could be addressed, would be required to go 3 outside. 4 DR. FREY: Okay, Zach, I think 5 you're -- okay, one last clarifying comment. 6 David? 7 DR. CHOCK: Have you prioritized 8 what to do based on the availability of your

9 resources? 10 MR. LANGSTAFF: No, we haven't. 11 We're going to do what we set out in the plan. 12 The parts of the plan say if available -- 13 resources are available. We haven't 14 prioritized yet because we don't know if 15 there's going to be any resources available. 16 DR. JACOB: I have one clarifying 17 question about in-house versus outside work. 18 So, the GEOS-Chem values that you're using, 19 are they coming from Harvard, or are they 20 coming from ICF? Because I know ICF has a 21 contract with EPA now to generate -- to repeat 22 essentially exactly the same GEOS-Chem

### 202-234-4433 Neal R. Gross & Co., Inc. Page 25 1 calculation that we've done at Harvard. And 2 I was wondering -- 3 MR. LANGSTAFF: Right, yes. ORD 4 is doing that essentially. So, we're going to 5 use those. That part is being done by a 6 contractor, but that's ORD work, and ICF is 7 doing those runs. 8 DR. JACOB: So, ICF is doing the 9 work for ORD, and you're going to get them

10 from -- 11 MR. LANGSTAFF: Right, yes. If we 12 can -- if somehow we could use those other 13 runs you're doing, that would be useful. 14 DR. JACOB: You already have them.

15 That's what I don't understand. 16 MR. LANGSTAFF: Well, I think they 17 need to be published, or -- they need to be 18 published I think to use them. But that would 19 be very useful to be able to use those. 20 DR. FREY: Okay. 21 DR. JACOB: Yes, that is a waste 22 really.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 DR. MILLER: You can get this 2 published and available, and this is the kind 3 of duplication that is just not acceptable in 4 today's environment. 5 DR. HUBBELL: I don't know if John 6 wants to comment on the process reason or not? 7 No? Okay, John does not wish to comment. 8 DR. FREY: Okay, Zach. I think 9 the floor is yours. 10 DR. PEKAR: Okay. So, I'll just 11 go ahead and -- and -- my goal here is -- 12 there's a fair amount of content in the 13 presentation. The overview of the risk, the 14 epi based risk assessment, is what I'm going 15 to be covering. There's a fair amount of 16 content in the presentation, but I'm much more 17 interested in hearing you guys talk about the 18 content, rather than me go on about it. So, 19 I'm going to try to move through this fairly 20 quickly. 21 So, just taking a look at what we 22 did in the last review. John had mentioned

### 202-234-4433 Neal R. Gross & Co., Inc. Page 27 1 this. We modeled 12 urban study areas, using 2 epidemiology based effect estimates. I think 3 there may be some people on the CASAC Panel 4 that are not familiar with the risk assessment 5 that was done for ozone. So, I will give a 6 little bit of background here. 7 We assessed risk for as-is current 8 conditions, as well as simulated attainment of 9 the current standard at that point, and then 10 also looking at what kind of risk reductions 11 would be associated with a simulated 12 attainment of alternate standard levels. 13 That's pretty much the way we do these NAAQS 14 risk assessments. 15 For the last review, we focused 16 exclusively on short-term exposure related 17 endpoints: morbidity and mortality endpoints. 18 They're listed here. 19 I'm not going to go through them20 in detail, but we did not consider any long21 term -- the term, even though that's a complex 22 term, any kind of long-term seasonally

### 202-234-4433 Neal R. Gross & Co., Inc. Page 28 1 averaged peak kind of endpoints. And 2 ultimately, the estimates, the risk estimates, 3 did provide -- did play a role in the decision 4 regarding the eight-hour standard. 5 So, obviously that's a little more 6 complicated statement, but they were used from 7 a policy standpoint. 8 In the design of the risk 9 assessment, or working on the design of the 10 current risk assessment, we started by setting 11 a series of policy related questions. So, 12 what did -- what kind of questions did we want 13 to address with the risk information? 14 Obviously beginning with the 15 nature and magnitude of public health impacts. 16 So what are the nature and magnitude of public 17 health impacts under the current conditions, 18 and if we attained the current standard? And 19 what is the magnitude of risk reduction under 20 alternate standard levels that we might 21 consider? That's pretty standard fare. 22 We are interested in how those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 29 1 risks vary across urban study areas. So, 2 let's say that we end up modeling 10 to 20 3 urban study areas. We'd be interested in 4 looking at how varied the risk reductions are

5 under alternate standard levels across those 6 study areas, and what the reasons for that is. 7 It helps us understand the nature of the risk 8 -- risk results and estimates. 9 I think the next three bullets we 10 have addressed in varying levels and past 11 analyses, but I think it's fair to say that 12 this is an area that we're really focusing 13 more on for this risk assessment. Those of 14 you who are familiar with the PM NAAQS risk 15 assessment, we did some of the same kind of 16 work I described for that analysis. 17 So, we are interested in looking 18 at the representativeness of the urban study 19 areas that we model. So, if we model again, 20 let's say, 12, 14 -- whatever number of urban 21 study areas we decide to model, we're 22 interested in knowing how representative those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 modeled study areas are of larger urban study

2 areas across the US. 3 So did we model study areas that 4 fall within the upper distribution with 5 regards to potential ozone risk? Did our 6 study areas sort of generally cover the 7 distribution and what is the nature of the 8 study areas that we modeled? I think that's

9 useful. 10 Then we were interested in 11 characterizing -- in looking at uncertainty 12 and variability. And I'll talk a little bit 13 more about that in a few slides. Then 14 ultimately we also would like to make some 15 kind of statement about the overall confidence 16 that we have in the risk estimate -- the risk 17 estimates. That's always an important but 18 sort of challenging task to take on. 19 So, this slide just provides a 20 flow diagram of the way that we conduct one of 21 these ozone risk assessments. This is 22 obviously very similar to a number of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 31 1 other NAAQS that we look at, for instance PM. 2 Just to go over it very briefly, 3 obviously there's a lot of complexity in each 4 one of these modeling element boxes. But just 5 to touch on it briefly, with regards to air 6 quality, we have to characterize recent air 7 quality we use, monitor data, obviously, 8 within an urban study area to -- as the basis 9 for characterizing current air quality. We 10 have to simulate alternate standard levels by 11 using some kind of rollback. I'll touch on

12 that later. 13 Then I think a point that John 14 mentioned that I'd like to reiterate is this 15 issue of characterizing what we used to call 16 policy relevant background. We're now looking 17 at obviously -- if you look at the total ozone 18 levels characterized by monitors, we'd like to 19 be able to apportion that into various source 20 categories, whether it's non-North American, 21 international, anthropogenic. It's maybe 22 North American anthropogenic. Then US

### 202-234-4433 Neal R. Gross & Co., Inc. Page 32 1 anthropogenic, looking for instance at natural 2 background, trying to divide that risk 3 estimate into its various components. We 4 think that that would be useful. 5 Next box down is concentration 6 response functions. We use epidemiology based 7 to effect estimates. I'll talk about the 8 endpoints we're considering modeling in a 9 slide or two. Then the final box at the 10 bottom in terms of inputs; we have to have a 11 characterizing of baseline incidence rates. 12 So, we can't model an endpoint if we don't 13 have baseline incidence rates. 14 Some of the long term -- what's 15 termed long term exposure studies look at 16 genetically differentiated populations in 17 terms of the response to respiratory effects. 18 That would be problematic for us to include in 19 the risk assessment because we don't have 20 baseline incidence rates for specific subsets 21 of the population. Not that we can't use 22 those kinds of studies in the evidence

### 202-234-4433 Neal R. Gross & Co., Inc. Page 33 1 analysis that goes into the ultimate decision, 2 but we may not be able to include those in the 3 risk assessment, for instance, because we 4 wouldn't have the baseline incidence rates. 5 Then we have to have population 6 data. So, we have to be able to enumerate the 7 populations that we're modeling for a given 8 endpoint. And then obviously the rest of the 9 flow diagram shows that these various modeling 10 inputs and elements go into a risk model, and 11 then we end up generating the risk estimates 12 on the right-hand side. 13 So, now, what I'd like to do is 14 talk about specifically what we're planning to 15 do hopefully that is somewhat new, or touch on 16 sort of new elements of this risk assessment. 17 I need to go through various components of

18 that. 19 So, these slides sort of track 20 that flow diagram that I just presented. So, 21 beginning with air quality characterization. 22 So, for the previous risk assessment, I think

### 202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 we've already touched on this. Yes, so, we're 2 just going to move ahead. 3 In terms of the monitor based 4 exposure surrogate, I think most people here 5 are familiar with the fact that we have a 6 number of monitors within a city. We tend to 7 use those monitors to construct an exposure 8 surrogate, a composite monitor, that usually 9 matches what was done in the underlying epi 10 study. 11 For this analysis, we're 12 considering that, but we're also considering 13 the use of Voronoi neighbor averaging, which 14 is a spatial interpolation technique for 15 generating -- and it's basically for getting 16 sort of a composite monitor estimate by taking 17 a weighted -- a distance weighted average of 18 the monitor values within an urban study area. 19 I can talk about this a little 20 more if we want to get into this, but part of 21 the reason for doing this, which I'll touch on 22 in a second, is that we're considering doing

### 202-234-4433 Neal R. Gross & Co., Inc. Page 35 1 the risk assessment within BenMAP, which is a 2 risk population health impact model that we 3 have in EPA. And it has some sort of 4 automated procedures for doing some of the 5 spatial interpolation techniques. 6 So, if we find, for instance, that 7 if we use a composite monitor approach where 8 we've matched monitors to an epi study, and if 9 we use the VNA approach, Voronoi Neighbor 10 Averaging, and we get essentially a similar 11 kind of estimate, it may be fairly and more 12 efficient to use the VNA approach. 13 So, this is one of the sensitivity 14 analyses we're looking at for how to structure 15 your exposure surrogate and modeling risk. 16 So, there's obviously some detail there that 17 I'm sort of moving through fairly quickly, but 18 just to touch on that issue, we can re-visit 19 it if people are interested. 20 And then just the final bullet. 21 We're going to simulate attainment of the 22 current alternate standard levels, using

### 202-234-4433 Neal R. Gross & Co., Inc. Page 36 1 quadratic rollback. John had already touched

2 on that. 3 So, in terms of risk 4 characterization, selection of health effects 5 endpoints, there was some discussion yesterday 6 with regards to the ISA on this topic, and 7 we're certainly open to more feedback from the 8 Committee on this. 9 For short-term exposure, well, why 10 don't we just stop for a second. We're likely 11 to, again, as we usually do, focus on 12 endpoints that were classified in the ISA as 13 either having a cause or a likely causal 14 degree of support. 15 And with regards to short term 16 exposure, that means that we're going to be 17 modeling respiratory morbidity endpoints. I'm 18 not going to get into those in detail here, 19 but that category, and also short-term 20 mortality endpoints. 21 So, these are going to be sort of 22 a similar set of endpoints with updated

### 202-234-4433 Neal R. Gross & Co., Inc. Page 37 1 studies to what we would've done in the last 2 review. But I think the point that is 3 particularly of interest here is we're also 4 considering modeling long-term, and I put that 5 in quotes, because there are a variety of 6 different metrics that are used in these 7 studies, in maybe a seasonally-averaged peak 8 hourly estimate, for instance, and there are 9 other metrics obviously. But we're 10 considering looking at long-term respiratory 11 morbidity that was classified as having a 12 likely causal association in the ISA. 13 There are a variety primarily of 14 asthma related hospital admissions studies in 15 specific cities, some areas of California, 16 that we're looking at possibly. 17 We're also considering looking at 18 long-term respiratory related mortality. Let 19 me just be very clear, considering as -- we're 20 saying considering because that's what we're 21 doing right now. We're definitely interested 22 in feedback from you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 38 1 If you look at the Jerrett study, 2 I think the point that we would point out is 3 that when you look specifically at respiratory 4 related mortality, my understanding is that 5 was not something that was called out in 6 previous studies. 7 Often in past studies, looking at 8 long-term related mortality, they looked at 9 more aggregated mortality categories, and 10 didn't look specifically at the respiratory 11 category in particular; when they did that in 12 the Jerrett study, they saw a more 13 statistically significant effect. 14 If we combine that with the fact 15 that some of these other long-term morbidity 16 studies looked in particular at respiratory 17 causes, and saw associations, we think there 18 may be a little bit more support there for 19 that mortality category, but once again, we're 20 interested in your feedback. 21 And then the final bullet down 22 here. For the PM NAAQS, we looked at modeling

### 202-234-4433 Neal R. Gross & Co., Inc. Page 39 1 mortality across a much larger set of cities 2 than just the case studies, and we're again 3 considering that here for ozone. Because when 4 we do it modeling and mortality for instance 5 across the ACS set of cities, that allows us 6 to look at a representativeness issue, and I 7 can talk about that in a second. 8 That also give us a much broader 9 assessment of ozone's public health impact, 10 not just in the subset of cities we looked at, 11 but at sort of a near national or sort of a 12 more -- a broader look at the urban impact 13 across the country. 14 Considering -- continuing with 15 risk characterization, the selection of urban 16 study areas. I'm going to hit this very 17 quickly. We're essentially going to use 18 criteria we've used in the past, which is do 19 we have good air quality data in these cities? 20 Do these cities provide good coverage 21 geographically and demographically for 22 different parts of the country? Are they

### 202-234-4433 Neal R. Gross & Co., Inc. Page 40 1 represented with effect estimates of interest 2 in some epi-studies that we're focusing on? 3 And one point I would like to 4 highlight here in the final bullet is that if 5 we decide to look at long-term related end 6 points, then we might want to look at the 7 relationship at some of the long-term -- the 8 peak to mean sort of air quality statistics 9 across the cities to make sure that we include 10 cities, for instance, that have very peaky 11 ozone levels, versus cities that have more 12 sort of uniform peak kind of metrics, to make 13 sure that we've covered a range of those 14 cities. 15 We did this with PM, looking at 16 the relationship between, for instance, daily 17 averages and annual averages. It's more 18 complicated, much more complicated, with ozone 19 because it's not as cleanly defined that way. 20 But we might want to look at that kind of an 21 air quality metric to make sure that we're not 22 excluding a city.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 41 1 Sorry about that for moving away 2 from the mic. That we're not excluding cities 3 that might have an interesting relationship in 4 terms of flatter or more peaky air quality 5 distributions. 6 Methods for adjusting uncertainty 7 and variability. So, I think the point to 8 highlight here, just to sort of move quickly, 9 is that we're considering the use or we're 10 planning to use the World Health 11 Organization's four-tiered approach to 12 addressing uncertainty and variability. 13 Basically, they provide a 14 structured means for looking at moving from a 15 qualitative treatment of these factors through 16 to sensitivity analyses and ultimately 17 probabilistic simulation. They specified a 18 degree of complexity should be linked to the 19 nature of the analysis for conducting how the 20 information is going to be used, the 21 complexity of the risk assessment itself. 22 Clearly based on the WHO

### 202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 assessment, we would probably do a full 2 probabilistic uncertainty and variability 3 characterization. We don't always have all 4 the information to do that with, but we will 5 certainly include a qualitative discussion and 6 detail of uncertainty and variability will 7 include a number of sensitivity analyses, some 8 of which I've already mentioned, and we will 9 include a probabilistic simulation, which 10 reflects confidence intervals in the effect 11 estimates. 12 This is typically what we've done 13 in the past, but this will be a little more

14 structured. 15 And then the representativeness 16 analysis: Essentially what we're going to do 17 -- let's say that we model 12 urban study 18 areas. We're interested, as I said before, in 19 looking at how those urban study areas compare 20 to urban areas in the U.S. in general. 21 We can do that in a number of 22 ways. One way is by looking at ozone risk

### 202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 related parameters, baseline incidence rates, 2 effect estimates when we have them across 3 individual cities, possibly demographic 4 profiles of the cities, air quality 5 statistics. And we can look at how our 12 6 urban study areas compared to a much broader 7 set of the urban areas across the U.S., and 8 once again see whether our urban study areas 9 fall within the upper distributions of those 10 various parameters, or if they're more evenly 11 spread, or for some parameters, they fall 12 towards the lower end and we have concern in 13 that case that we may not have captured the 14 higher risk profile urban study areas. 15 I think that's probably unlikely. 16 Once again, this is something that we did for 17 the PM NAAQS, and I think it was well 18 received, and I think provided our management 19 with a little more information in terms of how 20 our case studies mapped to urban areas in the 21 US in general. 22 The national scale mortality

### 202-234-4433 Neal R. Gross & Co., Inc. Page 44 1 estimates -- or the mortality estimates across 2 a larger number of cities would also play a 3 role here. We could look at how our mortality 4 estimates for the case studies that we model 5 compare to a much broader set of mortality 6 estimates; incidence per 100,000 -- various 7 statistics we can look at across a broader set

8 of urban areas. 9 And then I think the final point 10 that I'll make is that we're considering -- 11 we're planning to use the -- the environmental 12 benefits mapping and analysis program, or 13 BenMAP, to model our urban study areas. 14 This platform has been used 15 extensively for many years in supporting the 16 RIAs, the Regulatory Impact Analyses, that we 17 do for the NAAQS. So, it's not a new program. 18 It has a lot of pedigree to being used, and it 19 has been used to model individual cities, but 20 it hasn't been used specifically for the NAAQS 21 risk assessment. 22 Using a modeling platform like

### 202-234-4433 Neal R. Gross & Co., Inc. Page 45 1 this has a lot of benefits. Once you set it 2 up, you can run many different sensitivity 3 analyses. You can put different effect 4 estimates in there. You can look at different 5 lags. You can run various sensitivity 6 analyses. 7 There are also QA benefits. If 8 you use a program like this that has been 9 validated in a number of ways, you're much 10 more confident that you're not going to be 11 introducing errors, as compared with using 12 data sets, databases and shifting data around. 13 So, that's all I'll say with that. 14 So, that's the -- I think that's 15 the end of the presentation. 16 DR. FREY: Okay, thank you, Zach. 17 Are there any quick clarifying questions? Ed? 18 MR. AVOL: I just have one 19 question about the representativeness issue. 20 And you alluded to the peakiness of some urban 21 areas. And so -- and this whole focus sort of 22 on urban areas. And so, downwind, or a non-

### 202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 urban area, the shape of that ozone curve is 2 much more broader, which has implications when 3 you take into account physical activity and 4 the duration and exposure, and when people are

5 out and about. 6 And so, I'm not -- it's not clear 7 to me how that -- how that -- in terms of 8 risk, how that segment is going to be 9 considered, and whether those people are at 10 higher risk, but not being considered in this 11 sort of analysis. 12 DR. PEKAR: I mean I certainly 13 would say that some of the urban study areas 14 we're going to include would have outlying 15 suburban areas included in them, where you 16 might have larger demographics that are 17 active, depending on how we decided to define 18 polygons for the study areas. 19 So, if you're looking at LA, we 20 may have one - which is what we've done in 21 the past - have one urban area that we have an 22 exposure surrogate for. This is one of those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 47 1 times when with -- you know, it's a resource 2 issue again. I mean you can also divide these 3 areas, and this has been done clearly for PM. 4 Into separate polygons, you can get exposure 5 surrogates for different polygons, and then 6 look at how these might differ. 7 Those exposure surrogates would 8 then have different peak sort of different -- 9 different peak ratios, and you might be able 10 to look at differences in risk. Having said 11 that, that's the kind of thing we need input 12 from you on. I mean if there's a certain 13 issue that you think is very, very critical 14 for us to look at, we could really use that 15 input because we can only do so many of these 16 more segmented --

17 MR. AVOL: I understand the 18 resource issue. I just want to -- and I'm 19 happy to see that you're looking at the 20 representativeness. I just would say to the 21 extent that you look and see that everything 22 doesn't look like this, and there are some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 48 1 communities that look like that. 2 DR. PEKAR: Right. So, one way of 3 thinking about that is if we were going to 4 include a number of cities in the national 5 distribution, maybe to try to include some 6 areas that might be more representative of 7 what you're talking, even if it's a suburban 8 area to throw some of those in, and look at

9 how those would be covered. I'm not sure. 10 DR. HUBBELL: Let me just ask 11 specifically. Is there a specific area in 12 California that you think might be good -- 13 MR. AVOL: No, but the classic 14 example for us in California would be again, 15 downtown Los Angeles Riverside, compared to 16 Lake Arrowhead or places east, where you have 17 -- you don't have that NOx titrations. So, 18 you have those longer, broader many hours of 19 ozone at elevated levels. Elevated in terms 20 of elevated ozone, not elevated just in terms 21 of elevation. 22 DR. HUBBELL: Right. I think that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 49 1 would be really good for us to choose 2 something, a very broad area like that, that 3 has that difference in gradient. I think that 4 would be really useful. 5 MR. LANGSTAFF: I'll just mention 6 that with the exposure and the clinical risk, 7 we include those areas. So, we got that. We 8 include the downwind areas. 9 DR. FREY: Okay, Fred Miller, and 10 then Helen Suh wanted to ask some clarifying 11 questions. 12 DR. MILLER: Can you clarify for 13 me -- you said that you would be separating 14 out the contribution of US anthropogenic, 15 anthropogenic from Canada and Mexico, and 16 outside of North America. What is the value 17 of identifying the fractional contribution of 18 these, when they all lump into something you 19 can't control anyway? I don't understand what 20 that is going to give you. 21 DR. HUBBELL: Well, I don't agree 22 with the statement that we can't control --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 DR. MILLER: Well, it's a 2 clarification. I don't understand. 3 DR. HUBBELL: Well, what I'm 4 saying is we're taking the position that there 5 are -- there is truly natural background that 6 is something that is uncontrollable. One 7 could argue there are things you can do even 8 there to try to manage fires and things like 9 that. But what we're trying to do is identify 10 the fact that the science is telling us that 11 the ozone continues to cause risk as you go to

12 lower levels. 13 So, the question is of the risk 14 that's associated with those exposures, how 15 much is associated with different sources that 16 may be affected by different types of 17 policies? There are policies that can affect 18 US emissions. There are policies that can 19 affect Canadian and Mexican emissions, perhaps 20 a little differently, and then there are 21 policies that can in the long-term affect 22 international emissions, and that's what we're

### 202-234-4433 Neal R. Gross & Co., Inc. Page 51 1 trying to do. 2 DR. FREY: Okay, Helen and then 3 Jim. 4 DR. SUH: I have a clarifying 5 question. This is about the mortality. Do 6 you plan to look at mortality separately for 7 respiratory and CV, or is it just all cause, 8 or -- I know -- I know for the long-term, it 9 was for the respiratory, but I want to know

10 for the short-term. 11 DR. PEKAR: Yes, the short-term I 12 think we would do in a -- in the past, we 13 looked at those individual categories, and I 14 think we continued to do that again. I'm just 15 trying to make sure we've updated the 16 functions with the latest versions of the 17 various time series studies. 18 Yes, so we would definitely have

19 them -- 20 DR. HUBBELL: Again, one of the 21 benefits of using the BenMAP platform is it 22 has a very large database of functions already

### 202-234-4433 Neal R. Gross & Co., Inc. Page 52 1 built into it, including cost specific types 2 of functions, and it's very easy to add new 3 functions as we get the information. So, to 4 the extent that we have updated functions5 based on either individual cities or multi6 city studies for different cost specific 7 categories, we'll try to incorporate those. 8 DR. SUH: I know you've done that 9 before, but under what -- 10 DR. FREY: Use the mic. Thanks. 11 DR. SUH: I know you've used it 12 before, but can you remind me where. 13 DR. HUBBELL: Well, it's used in 14 all the regulatory impact analyses that we do 15 for all our major regulations. It's also been 16 used to produce several publically available 17 peer-reviewed publications, but looking at 18 ozone, looking at PM, and looking at a number 19 of different types of control strategies and

20 so forth. 21 So, it has been used. It's been 22 peer-reviewed. It was peer-reviewed back in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 53 1 2004. It has continually been updated, as we 2 go through, in terms of adding functions, 3 adding different ways of bringing in different 4 air quality modeling information and 5 monitoring data. 6 So, we've tried to keep it very 7 much up to date, based on the current 8 literature, and again it has been -- it has 9 been gone through peer review and it has been 10 published. Also, as it says here, it's also 11 available on our website. So, anybody can 12 download it. 13 Anybody can use it, and we also 14 have public training available. So, it's 15 pretty accessible to the public in terms of 16 providing comment. 17 DR. FREY: Okay, Joe. 18 DR. BRAIN: I have a clarifying 19 question too. Help me out as to how these two 20 presentations, John and Zach's, are linked. 21 And the first one, there's international 22 transport APEX. Again, looking at a variety

### 202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 of different populations. But then in your 2 presentation, it all came down to a single 3 health outcome, FEV1. Is that the same 4 platform that's being used now for a larger 5 variety of health outcomes? 6 I don't quite understand how they 7 -- are they separate efforts, or do they 8 overlap? 9 DR. HUBBELL: They are separate 10 but overlapping efforts. They start from the 11 same basis of air quality information, which 12 is why you see the same discussions about 13 background concentrations and you see the same 14 discussion about the monitored data that will 15 be used to inform the different risk 16 characterizations. 17 Where they depart is that for the 18 exposure modeling, we take another model, the 19 APEX model, and take those concentrations, and 20 put those through this more complicated model, 21 which has to incorporate time and activity 22 patterns, has to incorporate different

### 202-234-4433 Neal R. Gross & Co., Inc. Page 55 1 microenvironments, as opposed to the 2 epidemiology based approach, where we're 3 taking the monitored concentrations directly 4 as a surrogate for exposure, and that's the 5 real difference. 6 Then we populate the epidemiology 7 functions with those exposure surrogates. 8 DR. BRAIN: So, the first one is 9 really more sophisticated, more granular? I 10 guess my question is then why are you only 11 looking at FEV1 as the health outcome, when 12 there are many others, morbidity, mortality, 13 that in some ways seem more significant. 14 MR. LANGSTAFF: Well, the exposure 15 outcomes are based on clinical human studies 16 of exposure. So, they're not -- and that's 17 the primary endpoint we have for those, and we 18 have good quantitative information on, as 19 opposed to the epi studies, which is more sort 20 of a statistical association. 21 DR. HUBBELL: Yes, there are very 22 few at this point. There's a few that are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 56 1 coming out now, but there are very few 2 epidemiology studies that have used modeled or 3 actual monitored personal exposure. And so, 4 in order to be able to use that personal 5 exposure information, you have to have an 6 exposure response relationship, and we simply 7 don't have those for those epi studies. 8 Now, again, those are going to be 9 becoming available over the next cycle, but

10 not now. 11 DR. PEKAR: And I think just to 12 add a little bit, one thing is -- I'm not sure 13 how much of this will actually come into play, 14 but we might be able to use some of the 15 results of what John is doing to help 16 interpret some of the trends, the patterns 17 that we see in the risk information to a 18 certain extent because of characterizing 19 different -- the nature in detail of different 20 exposures in different cities. If we're 21 modeling epi in the same ones, we might be 22 able to talk about uncertainty a little bit.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 57 1 DR. HUBBELL: Well, not 2 uncertainty so much as heterogeneity and 3 understanding that if we see a different 4 exposure pattern, and in several of the cities 5 that we have modeled epidemiology functions 6 for, it might help us interpret those, and 7 say, "Well, if you have higher personal 8 exposure relative to the ambient 9 concentrations in New York compared to Texas, 10 well, that might explain why you see a 11 different magnitude or significance of the 12 underlying relationships." 13 DR. BRAIN: I would encourage 14 including heterogeneity as much as you can in 15 the second analysis. I think that really will 16 drive a lot of our decisions. 17 DR. FREY: Okay, we have Ed and 18 then Steven on clarifying questions. 19 MR. AVOL: So, is it appropriate 20 now to ask about the populations that they're 21 going to be considering? 22 DR. FREY: If that's a clarifying

### 202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 question, I think so. 2 MR. AVOL: So, you alluded to 3 children as being one of the issues that 4 you're going to be addressing. But my 5 question is you defined children as up to age 6 18. So, NIH defines it up to 21, and in fact, 7 males in terms of -- since you're looking at 8 lung function, FEV1 as an outcome, males, 9 actually, the lung development and growth 10 continues on into their early 20s. 11 And so, in terms of looking at 12 potentially sensitive at-risk populations, 13 you're truncating it a little bit short. 14 MR. LANGSTAFF: Okay, that's a 15 good point. 16 DR. FREY: Okay, Steve? 17 DR. KLEEBERGER: So, this is a 18 clarification question, or a clarification 19 point. So, this is -- this area is way out of 20 my expertise. But you had mentioned something 21 about genetics and genetic susceptibility, and 22 so forth. You had mentioned how you're going

### 202-234-4433 Neal R. Gross & Co., Inc. Page 59 1 to deal with that. Could you explain that 2 again? 3 DR. PEKAR: Sure. Yes, I sort of 4 glossed over that. I think when we were 5 looking at the long-term study summarized in 6 ISA, and starting to consider the endpoints 7 that we would model for risk, there were a 8 number of studies that when we looked at them 9 in more detail, we were actually looking at 10 populations that are differentiated 11 genetically for predisposition of respiratory

12 effects. 13 Just to be fair, there are people 14 here that are way more -- have a lot more 15 expertise than I do in this regard, but the 16 reality is we can't include those in a 17 quantitative risk assessment at this point, 18 because we don't have baseline incidence of, 19 for instance, asthmatic hospital admissions 20 for that particular population. And if we 21 don't have those baseline incidence rates for 22 a very specially defined population, we can't

### 202-234-4433 Neal R. Gross & Co., Inc. Page 60 1 include them in the risk assessment because 2 the effect estimates adjust the baseline 3 incidence rates. 4 Now, having said that, I wanted to 5 be very clear that those kinds of studies 6 could play a prominent role in the evidence 7 discussion that we advance to management when 8 they think about standards, which is obviously 9 a very critical factor that's considered when 10 the decisions are made, often the risk 11 information is more supportive. But I was 12 just trying to make that point. 13 DR. FREY: Okay, any other 14 clarifying questions at this point? I don't 15 see any. So, EPA, thank you very much for 16 your presentations, and appreciated your 17 input. We will move now to the public 18 comments. Before we get into the individual 19 public comments, I just wanted to check who is 20 actually here. We have three speakers listed, 21 one by telephone is Nicole Downy. Are you on 22 the line?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 61 1 DR. DOWNEY: Yes, I am. 2 DR. FREY: Okay, good. Another is 3 Julie Goodman, and she's here. Okay, all 4 right. We have a third one who is not going 5 to speak. So, we have, as I understand, two 6 public commenters on the agenda. 7 Okay, so the ground rules are: 8 five minutes, strictly enforced. Then, if 9 there are clarifying questions from the Panel, 10 we can entertain those. So, Nicole, if you're 11 ready, please proceed. 12 DR. DOWNEY: Okay. Good morning, 13 members of CASAC. Thank you for the 14 opportunity to speak today. I'll be talking 15 mostly about the use of policy-relevant 16 background in the standard-setting process and 17 in the health risk assessment. 18 My basic arguments are that 19 estimates of policy-relevant background should 20 be paired in time and space at a very high 21 resolution for health risk assessments. An 22 estimate of the uncertainty due to systematic

### 202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 model underprediction at high ozone values 2 needs to be included in the health risk 3 assessment, and that policy-relevant 4 background should actually include some 5 emissions necessary to maintain a basic level 6 of public health, including food, shelter, 7 heat and the public health infrastructure. 8 So, in the 2006 criteria document 9 in the current ISA, EPA discussed PRB in a 10 mean sense, i.e., 15 to 30 ppb. The form of 11 the standard, however, is aimed at the highest 12 extremes. So, the fourth highest three-year 13 average, NDA 8. 14 When regulations were aimed at 15 sort of greater than 85 ppb, this approach was 16 justified by arguing that PRB tends to be low 17 under high-ozone conditions. And this was 18 true for high ozone levels, but at levels 19 currently proposed for the 2011 NAAQS 20 reconsiderations, so 60 to 70 ppb, this 21 assumption is no longer valid. 22 But Fiori et al. and Wang et al.,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 63 1 which were the studies used for PRB in the 2 2006 and 2011 and current ISA, showed that the 3 influence to policy-relevant background peaks 4 between 50 to 70 ppb, in an illustration of 5 the different between PRB calculated at

6 seasonal means versus the annual fourth 7 highest values shown in Figure 1. 8 Previously, EPA has used monthly 9 averaged diurnal cycles of PRB for health risk 10 assessments. Again, this approach was 11 justified by arguing that the influence of PRB 12 was low for high-ozone events. As shown in 13 Figure 1, in the range of 60 parts per 14 billion, this is not the case. PRB can 15 represent a significant portion of observed 16 ozone, and its contributions should be taken 17 into account in the health risk assessments. 18 Importantly, this contribution 19 varies seasonally with elevation and with 20 ozone concentration, as observed by Fiori et

21 al. 2002 and 2003. We therefore recommend 22 that estimates of PRB be paired with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 64 1 observations at the highest spatial and 2 temporal resolution possible. EPA currently 3 has hourly estimates of PRB for 2006, '07 and 4 '08, from new high-resolution model runs 5 conducted at Harvard University. 6 It is well documented that models7 tend to underpredict the frequency of high8 ozone events, partially due to numerical9 limitations. The most recent version of GEOS10 Chem demonstrates the difficulties in 11 predicting the frequency of high-ozone days 12 above approximately the 98th percentile. This 13 is shown in Figure 2. 14 The numerical limitations that 15 limit models' ability to predict peak ozone 16 events extend to PRB simulations, and it is 17 likely that peak PRB estimates are also 18 underpredicted. The error associated with 19 this systematic underprediction of high-ozone 20 events should be quantified and effects of 21 this air should be propagated through the 22 health risk assessment process.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 651 Finally, the ISA defines policy2 relevant background as ambient ozone 3 concentrations in the absence of anthropogenic 4 emissions of all ozone precursors. This 5 includes eliminating all sources of combustion 6 and all emissions from agriculture. 7 This scenario itself would have 8 significant negative public health impacts. 9 No allowance is included for the basic 10 sustenance of life and health in the United 11 States. This becomes more important as the

12 health effects of ozone are calculated for

13 lower and lower levels. 14 A more reasonable approach would 15 be to include emissions to sustain a basic 16 standard of living, including shelter, food, 17 heat and the public health infrastructure. 18 EPA should optimize the health 19 benefits predicted from reducing ambient ozone 20 levels with the basic needs of human society. 21 Thank you. 22 DR. FREY: Okay, thank you. Are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 there any clarifying questions? Daniel? 2 DR. JACOB: I just simply would 3 like to say that I totally endorse what Nicole 4 just said, and I'll add some input into that. 5 Well, not into what she prepared, but into the 6 results that she used. I think she 7 interpreted perfectly, and this should 8 definitely be considered. 9 DR. FREY: Okay. Other questions? 10 Well, thank you, Nicole. 11 DR. DOWNEY: Thank you very much. 12 DR. FREY: Sure. Our next speaker 13 is Julie Goodman. 14 DR. GOODMAN: Thank you for the 15 opportunity to speak again on behalf of API. 16 The scope and methods plan relies heavily on 17 information assessed in the first draft ISA, 18 but many of the conclusions presented are not 19 reliable bases for determining health 20 endpoints to focus on in the risk assessment. 21 The core set of risk estimates 22 must be based on factors that are most likely

### 202-234-4433 Neal R. Gross & Co., Inc. Page 67 1 indicative of the true risk of individuals in 2 the population. For risk estimates based on 3 controlled human exposure studies, EPA plans 4 to determine the exposure levels at which FEV1 5 decrements between 10 and 20 percent will 6 occur, using a model for estimating FEV1 7 responses that was originally developed by 8 McDonnell et al. in 2007. 9 This model is based on controlled 10 human exposure studies conducted between 1981 11 and '92 that did not evaluate exposures less 12 than 80 ppb, and has been shown to overpredict 13 responses at lower concentrations for more 14 recent studies.

15 EPA should construct a new 16 statistical model based on all of the 17 available controlled ozone exposure studies. 18 This model should incorporate a threshold,19 because the biological mechanism of ozone20 induced lung function decrements is known to

21 have a threshold. 22 In addition, the model should

### 202-234-4433 Neal R. Gross & Co., Inc. Page 68 1 reflect the evidence that group mean FEV1 2 decrements associated with exposure to 60 ppb 3 or less are not statistically different than 4 those with filtered air. 5 I would like to point out although 6 there's perhaps a small debate over whether 7 effects occur at 60 ppb, EPA and CASAC have 8 all agreed that there's no differences between 9 40 ppb and filtered air, indicating a

10 threshold of at least 40. 11 EPA's approach to assessing the 12 epidemiology evidence in ISA did not consider 13 many of the limitations and uncertainties 14 associated with the underlying studies. EPA 15 focused on the positive associations reported 16 in the studies, whether they were 17 statistically significant or not, and often 18 discounted null results. And this led to the 19 consistency of the results being routinely

20 overstated. 21 EPA also did not appropriately 22 weigh the evidence for causality, and for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 69 1 these reasons, conclusions of causal or likely 2 to be causal are generally overstated, and 3 there is a high possibility that the actual 4 risk for a given endpoint is or approaches

5 zero. 6 Given the degree of uncertainty 7 associated with the causal relationships in 8 the ISA, and even greater uncertainty 9 associated with other classifications, only 10 health points for which ozone is deemed causal 11 by EPA's definition should be considered in 12 the core risk assessment; thus, only studies 13 of respiratory morbidity associated with 14 short-term exposure to ozone should be 15 considered in the core risk assessment, and 16 health endpoints classified as likely causal 17 should only be considered in the sensitivity 18 analyses. 19 EPA should not consider including 20 long-term respiratory mortality as part of the 21 core risk assessment. Several large studies 22 have examined long-term ozone exposure and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 respiratory and cardiopulmonary mortality and 2 have not reported positive associations. And 3 this is acknowledged in the ISA. 4 Only the follow-up study of the 5 ACS cohort by Jerrett et al. in 2009 has 6 reported an association with long-term 7 respiratory mortality and the study has many 8 limitations that weaken the evidence for 9 causality. 10 So, together the evidence for an 11 association between long-term exposure to 12 ozone and mortality is overwhelmingly null, 13 and one weakly positive study with several 14 limitations is not sufficient to suggest a 15 causal relationship or be used in a risk 16 assessment. Thus, this endpoint should not be 17 evaluated in the core risk assessment or 18 sensitivity analyses. 19 Another issue is that many of the 20 studies relied on for causal associations in 21 the ISA reported results that did not achieve 22 statistical significance, and it is assumed

### 202-234-4433 Neal R. Gross & Co., Inc. Page 71 1 these results will be used in the risk

2 assessment. 3 If so, the core set of risk 4 estimates must include the case that the 5 possible risk is zero. In addition, some of 6 the multi-city studies reported decreases in 7 community-specific mortality for certain 8 cities of interest. If EPA does include the 9 endpoint of short-term mortality in the risk 10 assessment, it must address how these 11 community-specific negative effect estimates 12 will be used. 13 EPA does not plan to consider a 14 threshold concentration response model in the 15 short-term core analysis, or in the 16 sensitivity analyses of the risk assessment, 17 because the ISA concludes there is little 18 support in the literature for a population 19 threshold for short-term ozone exposure

20 related effects. 21 And this is not true, however, as 22 the controlled exposure studies clearly show

### 202-234-4433 Neal R. Gross & Co., Inc. Page 72 1 a threshold effect, as I've discussed in 2 written and oral comments before. I believe 3 the evidence suggests that 60, but clearly we 4 all agree, at 40 ppb. 5 In addition, a short-term exposure 6 threshold for effects on lung function in 7 response to ozone is also consistent with 8 biological data that support a mode of action 9 related to antioxidant defenses. Because the 10 controlled studies and proposed modes of 11 action for respiratory morbidity support the 12 existence of a threshold, a threshold CR model 13 should be used for the core set of risk 14 estimates, and other models can be used in the 15 sensitivity analyses. 16 Finally, EPA plans to use 17 distributed lag models for CR functions when 18 available, but will consider information in 19 the ISA to determine if there is biological 20 support for selecting a specific lag period 21 for a given health effect. EPA appears to be 22 open to using different lag periods for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 73 1 different cities, and this raises questions 2 regarding the biological plausibility of the 3 reported associations. 4 If there is no biological 5 justification, lag periods -- 6 DR. FREY: Thirty seconds. 7 DR. GOODMAN: -- should not differ 8 by city for any given endpoint. Instead, EPA 9 should decide a priori which lag models has 10 the most biological plausibility for each 11 health endpoint, and then use that model in 12 the core risk assessment. 13 So, in conclusion, EPA's plan for 14 the risk assessment for ozone-related health 15 effects should carefully consider these points 16 so the core set of risk estimates can be based 17 on factors that are most likely indicative of 18 the true risk of individuals in the 19 population. Thank you. 20 DR. FREY: Thank you, Julie. You 21 had five seconds to go. Are there any 22 clarifying questions? Yes, Fred?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 DR. MILLER: Could you clarify, 2 because I tend to agree about the 3 standardization of lag, but what if these 4 areas that they pick, the lag actually 5 reflects major differences, like in 6 ventilation with the windows open and things 7 of that nature? So, would that modify what 8 you're talking about? 9 I can understand if you're talking 10 about comparable areas, that it should be 11 whatever the standard lag is. But could there 12 be situations whereby it's different because 13 of major dynamics of how the area is and 14 ventilation and things of this nature? 15 DR. GOODMAN: Yes, there could 16 definitely be differences, but that's based on 17 biology. So, as opposed to sort of letting 18 the statistics drive it and saying using 19 different lags because the statistics are 20 something different, there should be a 21 biological justifiable reason for using 22 different lags.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 75 1 DR. FREY: Any other questions? 2 Yes, John? 3 DR. BAILAR: I'm a little 4 concerned about the weight that you and EPA 5 both put on whether or not data attain a 5 6 percent significance level. You do it in 7 different directions, but I think you're 8 giving it too much attention. 9 That 5 percent was originally 10 devised for application to laboratory and 11 field experiments that could be repeated when 12 there were questions about the results. And 13 it has been validated by now a good many 14 decades of experience as useful in that

15 context. 16 It was not devised, and I think is 17 not appropriate, for use with observational or 18 one-time studies, things that can't be 19 repeated, where you have to rely much more on 20 your sense of the context, the whole Gestalt 21 of the available knowledge, and I think you 22 should pay much less attention to whether

### 202-234-4433 Neal R. Gross & Co., Inc. Page 76 1 something is above or below that artificial

2 number. 3 DR. GOODMAN: Well, I think my 4 main concern is that -- particularly with the 5 observational studies that it's not just one. 6 You have many, many studies, and in some, 7 there is statistical significance and some 8 there aren't, and some the point estimate is

9 above one and some below one. 10 And so, the idea is you need to 11 look at everything together, and if altogether 12 you see consistency, everything is above one, 13 be it statistically significant or not, that's 14 stronger evidence for causality than if it 15 jumps back and forth. 16 I think statistical significance 17 is one of the considerations when you consider 18 all the data together. 19 DR. BAILAR: It is one, but only 20 one, and I would not give it very much weight. 21 DR. FREY: Okay, any other 22 clarifications? All right, well, thank you,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 77 1 Julie. All right, my understanding is that 2 those were the only two public commenters who 3 wanted to speak, and so I will close out the 4 public comment session. 5 We will now begin our consultation 6 discussion on the exposure analysis issues. We 7 have four discussants identified, who I 8 presume have prepared some remarks. We'll 9 start with those, and then we'll open it up to 10 a broader discussion by all Panel Members. 11 So, I'd like to start with Daniel 12 Jacob, and then George Allen, Ted Russell, and 13 David Chock. So, Daniel, the floor is yours. 14 DR. JACOB: So population exposure 15 is not at all my area. So, I have absolutely 16 nothing useful to say. 17 (Laughter.) 18 DR. FREY: Well, nonetheless, if 19 you could say it into the mic. 20 DR. JACOB: Yes, okay. Well, I 21 can say it into the mic as well. Population 22 exposure is definitely not my area. I read

### 202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 the chapter. I thought it was reasonable, but 2 I'm not an expert. So, I don't have anything 3 useful to say. What I have something useful to 4 say is about the treatment of the 5 international and national component. 6 It is for this afternoon, but I 7 will not be here. So, I don't know if I can 8 say something now, or -- ? 9 DR. FREY: Well, perhaps you 10 should do it now then. 11 DR. JACOB: Okay, thank you. It 12 won't take very long. So, I was very 13 interested by the way EPA was proposing to 14 deal with the international and national 15 component. 16 I had an offline discussion with 17 Ted Russell yesterday about how to deal with 18 a bias in those model estimates. Because, as 19 Nicole pointed out, that bias could actually 20 have some important indications, as we 21 consider lower standards, and I think that the 22 model is good that it's not perfect. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 79 1 there's some regions and some seasons where 2 it's doing worse than others. 3 I think there's a good way to try 4 to debias the model, following the terminology 5 of Ted, by -- if you use the CASTNET sites 6 that are regionally representative, and then 7 you look at the bias between the model and the 8 observations at the CASTNET sites, and then 9 apportion this bias to the different 10 contributors, so the international pollution 11 and then the North American pollution 12 contribution. 13 And the reason for this, for doing 14 this, the reason I think this is the best 15 method is because when I look at the model 16 simulation of ozone at high altitude in the 17 free troposphere, comparison with ozone, with 18 satellites, there's no systematic bias at 19 northern mid-latitudes, even various seasons, 20 different altitudes, different regions. 21 So, I think that most of the bias 22 in the model arises at trying to reproduce the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 80 1 surface conditions, and may reflect 2 topography. It may reflect some uncertainties 3 in the chemistry, such as isoprene, halogens, 4 and so on. And so, therefore, this is why I 5 think that the Bison model (phonetic) can be 6 apportioned to the different contributors in 7 a way, in a proportional way.

8 DR. HUBBELL: Can I ask one 9 clarifying question on that, which is, one of 10 the concerns we've had about trying to do bias 11 adjustment for GEOS-Chem or other background 12 ones is the grid resolution usually is not as 13 good as some of the more regional models, and 14 there's concern about, you know, you got a 15 monitor that may not be necessarily just 16 reflecting background, and may have local 17 sources or other things contributing to it 18 that you can't pick up with something like the

19 GEOS-Chem model. 20 So, the question is, are we really 21 adding additional problems when we try to do 22 bias correction using the CASTNET sites?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 81 1 DR. JACOB: Well, you know, bias 2 at a particular site will always be difficult 3 to interpret. But I think that I was focusing 4 more on regional skill corrections, such as 5 the fact that the southeast in the summertime 6 is too high in the model background. 7 DR. HUBBELL: So, would you do an 8 average bias correction then, rather than 9 monitor to grid cells and individual grid 10 cells? Would you interpolate sort of a bias -

11 - 12 DR. JACOB: I would be very wary 13 about using individual grid cells because, 14 particularly in the west, a lot of the data 15 are urban, and clearly, the model will not 16 reproduce properly urban data. And then you 17 also have local topography issues. 18 So, what I would suggest is again 19 using the CASTNET sites because we're getting 20 away from at least the urban issues. And then 21 using some kind of regional smoothing, and -- 22 with the understanding that there will be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 local areas that are not accounted for. Those 2 I don't know how to deal with properly. 3 DR. HUBBELL: Okay, but regional 4 smoothing sounds like something we could do -- 5 DR. JACOB: And using the CASTNET 6 sites. 7 MR. LANGSTAFF: I have a question 8 related to that. So, I can see the model has 9 large grid cells. And so, it's not really 10 designed to compare with individual sites. 11 You might average some sites, but when it's 12 monitoring the current conditions that the 13 ozone surfaces are more uneven, but if you're 14 modeling natural background, I wonder if you'd 15 expect to be less biased because the ozone 16 surface would be more smooth, or is that not

17 the case? 18 DR. JACOB: Well, there would 19 still be bias because of chemistry and 20 topography. That would affect the natural 21 background as well as the pollution

22 enhancement.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 83 1 MR. LANGSTAFF: So, you think the 2 bias might be in the same direction?

3 DR. JACOB: Yes. 4 MR. LANGSTAFF: Okay. 5 DR. JACOB: I think that the bias 6 would apply to all these contributions the 7 same way. Let me give an example. Imagine 8 that there's a bias because we're not 9 accounting properly for some local NOx source 10 or isoprene chemistry or halogen chemistry. 11 Well, you know, that bias will propagate to 12 the natural component in the same way as to 13 the pollution component. 14 MR. LANGSTAFF: Yes, but I'm 15 wondering, for example, if you have an area 16 that is high on NOx emission on the current 17 day, so the model might be biased there, but 18 when you reduce the NOx emissions to natural 19 sources, then the ozone could be higher, and 20 so I wonder if the bias couldn't go the other 21 direction in a case like that. 22 I mean, we see cases where the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 84 1 natural background run gives you guys higher 2 than urban areas. So, you'd say, "Well, the 3 bottle is biased high there." But then if you

4 -- 5 (Simultaneous speaking.)

6 DR. JACOB: That wouldn't be an 7 issue with the CASTNET site. You got to go 8 away -- 9 MR. LANGSTAFF: Right, right, 10 right. 11 DR. JACOB: This is why I'm really 12 insisting on using CASTNET. 13 MR. LANGSTAFF: Okay, yes. 14 DR. JACOB: Not using the AQSB as

15 a CASTNET. 16 MR. LANGSTAFF: Got it. 17 DR. FREY: Okay, Daniel is that -- 18 okay, thank you. Good. I did want to make, 19 I guess, two points before I call on George. 20 One is that after we go through the four 21 discussant comments, I will give an 22 opportunity for Panel Members on the phone to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 85 1 comment, and I think that includes John Samet, 2 who was on the phone. Are there other Panel 3 Members on the phone? 4 DR. WEATHERS: Yes, Kathy

5 Weathers. 6 DR. FREY: Okay, great. And the 7 second thing is that we would like to get the 8 written comments from the Panel Members on 9 this consultation in two weeks. So, June 3rd 10 is two weeks from today. So, just please keep 11 that in mind. 12 You may find it convenient to 13 change your comments today while we're still 14 here, or on your flight home. So, sooner is 15 great, but no later than June 3rd. With that, 16 George? 17 MR. ALLEN: Thanks, Chris. First, 18 a general comment. I'd like to thank EPA for 19 making the BenMAP tool available to the 20 community. I think it's a great tool. Has a 21 lot of wide range of applications beyond how 22 it's being used here. That's great.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 Those kinds of tools are just 2 extremely valuable over a very large scope, 3 specifically on this section in general. Ed 4 kind of stole my thunder here already, but I

5 am concerned about the unusual nature of '08

6 to '10.

7 In much of the eastern half of the 8 country, '09 was an extreme outlier, and 9 neither '08 and even more so '10 were at most 10 normal or below normal. So, taken together as 11 a three-year period, they are probably some of 12 the cleanest three years in history by a 13 significant margin, depending which metric you 14 use since we started measuring ozone. 15 Now, most of that, I think, is 16 meteorology. Some of it might've been the 17 profound economic bump we hit, but I think by 18 and large it is meteorology, and I provide 19 some Region One plots, because they were 20 there, and I didn't have to do them, in my 21 comments that make it clear how unusual '09 22 was, and put '08 and '10 in context for Region

### 202-234-4433 Neal R. Gross & Co., Inc. Page 87 1 One at least. 2 My question is, I know EPA for 3 their trends work does do meteorological 4 corrections, and I guess one question I'd have 5 here is, is that something that could or 6 should or would be done here, or would you 7 perhaps broaden the range of years to include 8 some years that are more balanced? Meaning 9 some high years to counterbalance the low 10 years? 11 EPA Kameler et al. from '07 in 12 atmospheric environment published a nice 13 technique for corrections, and in my comments. 14 It's on the EPA Trends website. They have a 15 little map of the value of the correction over 16 the eastern two-thirds of the US, and it's 17 quite distinct. 18 In fact, if you look at the 19 extremes between '03 and '07, there's a 20 correct range of more than 10 ppb. That's a 21 lot. So, this is a big issue if you're going 22 to be using any three-year period to estimate

### 202-234-4433 Neal R. Gross & Co., Inc. Page 88 1 exposure from that. So, that's a huge 2 question there. And that needs to be 3 addressed in the plan and hopefully 4 implemented. Hopefully somehow, not just 5 addressed, but implemented in some way that 6 avoids that problem. 7 My only other comment is on the 8 issue regarding the spatial heterogeneity of 9 ozone across -- primarily across urban areas. 10 In rural areas, at least if you don't do 11 vertical stuff, it's fairly homogeneous. Of 12 course, if you do vertical stuff, then we're 13 back to huge ranges with elevation, but that's 14 a different story. 15 A lot of sites, cities, take 16 Boston for example, because it's one of the 12 17 in the last time around. It's also one that 18 I'm very familiar with. There's really only 19 going to be one core urban site that 20 represents, say, a five-mile radius of 21 downtown Boston, and that's the Roxbury NCOR 22 site.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 89 1 There's two other sites that are 2 near Boston. One is actually not too far from 3 it, but out on the harbor. Not -- I mean, 4 physically it's not floating, but it's out on 5 Long Island, out on the harbor, away from the 6 core downtown and local NOx titration sources. 7 The other one is Lynn, and not far 8 from where I live, about 12 miles to the 9 northeast. Those are the two sites, actually 10 very similar slope of almost one, intercept of 11 almost zero. But then when you look at either 12 of them versus the Roxbury site, the 13 correlation is still decent, and the slope is 14 a fairly narrow one, but I show a plot of Lynn 15 versus Roxbury. But there's an intercept of 16 about 9 ppb, and I don't know in the 17 conceptual framework that you folks are 18 working with whether -- I mean, sure if 19 everything goes up and down the same, that's 20 good, and it does. But when you have an 21 offset like that, is that a problem in terms 22 of your approach? I'm not sure, but it could

### 202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 be. 2 And I think that should be 3 addressed because you may find this in other 4 areas as well. Like I said, in the 5 requirements for ozone monitoring in urban 6 areas that are, say, a million or so, 7 generally you're only going to have one 8 monitor in the core urban area. 9 You have some outlying -- I mean, 10 in eastern Mass there's a lot of ozone 11 monitors. But if you want to reflect the core 12 urban population where the people live and 13 where most of your epi population is going to 14 be, that's a different story. And as we've 15 noted before, exposure misclassification can 16 really do a number on your estimate of the

17 effect. 18 And so, that is a challenge 19 because of the urban titration effect in 20 medium-sized cities. As I said yesterday, 21 L.A. is not Houston is not Atlanta is not New 22 York is not Boston. All these cities

### 202-234-4433 Neal R. Gross & Co., Inc. Page 91 1 spatially are different. So, you need to 2 hopefully get some local expertise for the -- 3 maybe you're only picking two cities this time 4 just for budget constraints, I don't know. 5 But seek out local expertise to better 6 understand the issues. 7 An example I gave was the Boston 8 Blue Hill site. It's only ten miles from 9 Boston, but it's up 600 feet, and it's very 10 different than any other site in the metro 11 Boston area. Unless you know the area 12 locally, you may not pick up on that, and you 13 may miss or misuse that kind of information. 14 So, that's a concern there. I 15 mean, I guess the point there is, seek local 16 expertise. People don't understand the siting 17 and the Gestalt of the area in question. And 18 I think that's essentially the core of my

19 comments. Thanks. 20 DR. FREY: Okay. Thank you, 21 George. Ted? 22 DR. RUSSELL: Okay. Yes, a few

### 202-234-4433 Neal R. Gross & Co., Inc. Page 92 1 things. 2 DR. WEATHERS: Ted, could you speak 3 into the mic? 4 DR. RUSSELL: Yes, I'm getting to 5 the mic. So, in terms of the quadratic 6 rollback, I know that this was something that 7 was not -- there was some confusion on exactly 8 how it was done last time. And I think that 9 just needs to be better explained this time 10 around. A diagram would help. 11 One thing that I think you're 12 going to have to do this time, particularly 13 with discussion of the PRB, is address how you 14 will modify concentrations lower than the PRB, 15 and with reasons why. 16 And I think if you look at Table 17 3-6 in the ISA, that can give you some 18 guidance as how you might do that. Actually, 19 that table suggests that it may not have to be 20 modified very much, except at the very low 21 levels. But again, if we're looking at the 22 levels of ozone we're looking at, particularly

### 202-234-4433 Neal R. Gross & Co., Inc. Page 93 1 for the standard, I mean we're starting to 2 look at much more time being spent at these

3 sort of lower ozone levels. 4 As Daniel mentioned yesterday, we 5 talked about what to do with debiasing the 6 PRB, and we discussed how you would apportion 7 the bias to different parts of the 8 contributions to the PRB. 9 And I think -- you know, I won't 10 be quite so prescriptive as Daniel. I think 11 what -- as to how you'd want to do it, I can 12 see what Daniel is doing. I would say that's 13 something you guys have to spend a fair amount 14 of time thinking about, assessing, justifying, 15 and spelling out very, very clearly in the 16 REA, not only what you did but why you did it, 17 and the implications. And then also assessing 18 what the uncertainty is associated with the 19 method you used, and what the PRB -- the 20 uncertainty in the PRB. 21 So, again, it's primarily just 22 giving the thought and making sure that you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 justify what you've done and spell it out. 2 So, that's that on what to do about the PRB. 3 Just keep in mind, I think you have to be very 4 careful since you are going to be mixing 5 observed and modeled quantities. So, there's 6 that issue. 7 It was not apparent from what I 8 read why you would use the GEOS-Chem from 2006 9 to 2008 in observations from 2008 to 2010. 10 It'd be really nice if those overlapped, and 11 as has been pointed out before, paired, very 12 closely paired in time and space. 13 I can actually see moving back 14 from 2008 to 2010 for multiple reasons, not 15 only to match GEOS-Chem, but as George has 16 pointed out, there was both meteorological 17 issues on the East Coast, but also the 18 recession. 19 In the modeling that we've done, 20 we see that the recession has had a real 21 impact on ozone levels that -- you may not 22 want to use 2009 and 2010 just because they

### 202-234-4433 Neal R. Gross & Co., Inc. Page 95 1 are different. The Southeast hasn't quite had 2 the same issues meteorologically as the 3 Northeast, but we still see the recession and 4 lower ozone during those two periods. 5 Spell out better how you're going 6 to treat the methane. I mean, it really was 7 unclear, and I think you have to do that. And 8 what -- again, how that treatment impacts your 9 results. Just discuss the uncertainties. 10 There's the issue of number of 11 cities. Oh, actually another thing I think 12 the REA is going to have to do is look at the 13 likely change of PRB levels over time, and the 14 implications of those on the potential health 15 benefits and welfare benefits over time. 16 I think, particularly with what 17 we're seeing, just doing sort of a stationary 18 assessment will not get that answer correct. 19 In terms of the number of cities 20 it would be, three poses some real problems. 21 But now you're talking many more than three 22 from the sounds of it.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 96 1 DR. PEKAR: Let me just be clear 2 about that. Three on the exposure, detailed 3 exposure modeling that John was talking about. 4 But for the epi side, which is a little easier 5 to run from a resource standpoint, a larger

6 number. 7 DR. RUSSELL: Well, let me say I 8 hope it's more than three. You know, and 9 three I'm not sure -- we'd learn something 10 from it. And finally, just make sure that 11 the mathematical presentation is correct on 12 data. There were just some minor issues last 13 time. But that's it. 14 DR. FREY: Okay, thank you, Ted. 15 David Chock? 16 DR. CHOCK: Okay, I only have a 17 few points to make. You're talking about 12 18 urban areas, and you're going to use the 19 consolidated human activity database. One 20 concern I have is that some of the database is 21 very old, 1980s. And you do have some new 22 database that was created in 2009, the RTI

### 202-234-4433 Neal R. Gross & Co., Inc. Page 97 1 NSAS database. 2 But again, the database may not be 3 too big because it's really -- I mean, if 4 you're talking about on a per city basis. So, 5 that could be a concern in describing 6 adequately the CHAD human activities, for 7 example. 8 And in the uncertainty area, you 9 talk about the model formulation uncertainty. 10 That is going to be very difficult to address, 11 I suppose. Maybe you ought to be more 12 specific on that. 13 On the quadratic rollback, I would 14 recommend that you first look into how 15 different percentiles -- formulation would be 16 relative to, let's say, the mean value. 17 Because the more extreme you are, the greater 18 the answer then associated with it. In fact, 19 the form may be different for different areas 20 as well. So, that's not straightforward issue

21 as well. That's all I have. 22 DR. FREY: Okay, thank you, David.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 Let's see. Before we get into Panel Members 2 who are here, let me just give an opportunity 3 if there are Panel Members on the phone who 4 would like to make some comments. John Samet

5 or Kathleen Weathers?

6 DR. SAMET: I don't know about 7 Kathy. This is John. I'll make just a few

8 comments about the -- I'm about to run out of 9 battery, hang on one second. Let's see, I'm 10 still here? 11 DR. FREY: You're still here, yes. 12 DR. SAMET: Okay. So, let me just 13 make a few comments. One, there was a little 14 bit of discussion. Of course, every time I 15 hear this now I get a sense of deja vu, but I 16 think it'll be very important to just up front 17 in the document be very explicit about how -- 18 what is being done now different from what was 19 being done the last go-round, and how changes, 20 let's say, perhaps in both response functions 21 or whatever, how they relate if changed to new 22 evidence that has accumulated.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 99 1 So, I think that should be really 2 very explicit. The term "policy-related 3 background" has certainly taken on a life of 4 its own, and I hear a shift in terminology, 5 and I -- that's fine, but the word and the 6 concept is certainly there. 7 And I think whatever is said, and 8 I heard the discussion about sort of sources 9 and trying to support policy directive and 10 what might be the most critical sources, still 11 I think you'll have to bridge off from a 12 concept that has been there before. So, I 13 think that needs to be discussed explicitly. 14 I guess the only other comment: 15 I'm still struck by George Allen's comments. 16 I remember that one high point in Milton. The 17 question is whether the modeling that would be 18 done becomes so location-specific that 19 generalizability becomes an issue, given that 20 only a limited number of locations are going 21 to have the more detailed modeling effort. 22 So, I guess the question of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 100 1 generalizability will be quite critical. So, 2 those are my two main comments. 3 DR. FREY: Okay, thanks, John. 4 DR. WEATHERS: If I can just add 5 briefly, this follows on and underscores what 6 Ted and Daniel said, which is the importance 7 of using field data and CASTNET in particular, 8 but other field data as well, to anchor, to 9 prepare, and to make possible the debiasing or 10 spatial smoothing and honing of the model is 11 just incredibly important. 12 So, another voice for urging EPA 13 to use those data in creative ways. 14 DR. FREY: Okay, thank you. 15 Helen, you wanted to make a comment. 16 DR. SUH: Just a couple things. 17 One is about the APEX model. One of the 18 concerns I have is that when you do the 19 modeling, especially for the elderly group, 20 who don't spend a lot of time outside, I'm 21 worried actually that the concentrations -- 22 the exposures you're going to predict are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 101 1 going to be very low. And I'm wondering about 2 whether there has been some thoughts about 3 what that impact might be of having extremely 4 low exposures, but perhaps not so much 5 variability on your subsequent examination of 6 the impact on FEV1. 7 And so -- because there is a 8 chance, because indoor ozone levels are so 9 low, and people spend so much time inside, 10 especially the elderly, that actually you 11 might get very, very low predictions of 12 exposure. 13 And so, the question is what 14 impact would that have on your FEV1 and your 15 estimates of risk, and then if you're going to 16 take those estimates of risk and take it one 17 step further, and compare it to maybe what's 18 been found in the controlled laboratory 19 studies, or in the epi studies, it's going to 20 be a little bit of a mismatch. 21 And so, I think there should be 22 some -- it makes me nervous because then

### 202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 there's going to be these estimates of risk, 2 and there's going to show that there's really 3 -- you know, at these very, very low levels, 4 there's not been any laboratory studies done 5 at those very, very low levels. 6 And so, from the personal exposure 7 to ambient ratios that's in the ISA, there's 8 like 0.1 or 0.2. So, if you take the, if you 9 just carry it forward, I'm worried there's 10 going to be a mismatch between the exposures 11 that you estimate, the controlled laboratory 12 studies that you're using to develop the dose 13 response curves, and then the subsequent 14 estimates of risk; I think that should just be 15 thought about because then you're going to 16 have to try to carry it forward, and maybe 17 you're going to try to relate it to what's 18 been found in the epi studies, and it might 19 not all go together. 20 So, I think there has to be some 21 thought. That's why APEX makes me nervous, 22 especially for the elderly group, because they

### 202-234-4433 Neal R. Gross & Co., Inc. Page 103 1 just don't spend that much time outside. So, 2 I guess I don't know what the answer is, 3 truthfully.

4 MR. LANGSTAFF: Yes. I mean I 5 think it'll agree with the clinical studies, 6 but you know, if the elderly are indoors most 7 of the time at lower exposure, but they also 8 have lower ventilation rates, and to get the 9 FEV decrement you need the higher ventilation 10 rates and higher exposure at the same time. 11 So, you're right; they're going to 12 be very low. Very low. 13 DR SUH: And I'm not sure it's 14 going to be a great use of your time and

15 resources. 16 MR. LANGSTAFF: Well, it'll be 17 consistent with our clinical studies, but it 18 might not be consistent with the epi studies. 19 DR. SUH: Yes. I just think in 20 terms of prioritization, and thinking about it 21 -- but I also think you need to think about 22 the results that come out, and whether or not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 104 1 they're going to help you at all, given that, 2 one, the mismatch between the clinical data 3 and the exposure data that's going to be 4 missed. And so, just something to think

5 about. 6 The other thing, actually I was 7 wondering, and maybe this isn't for you guys. 8 It's for the ISA people. Given that you guys 9 aren't really going to use the PRB that was -- 10 you're going to use some other variations on 11 the theme, but maybe that should be talked 12 about in the ISA as well, because the ISA only 13 really talks about the traditional PRB 14 definitions. 15 DR. HUBBELL: And to be clear, 16 they are talking about some of the other 17 things too, but they still call it PRB. Yes, 18 we agree. 19 DR. SUH: But I think there should 20 be consistency across terminology. 21 DR. HUBBELL: We agree. We have 22 discussed it. We just need to get our

### 202-234-4433 Neal R. Gross & Co., Inc. Page 105 1 terminologies a little straighter. And I take 2 very clearly John's point that there needs to 3 be a bridge, to make sure people understand 4 that we're talking about concepts that are 5 related to the same thing we talked about last 6 time. We're just trying to evolve them a bit. 7 DR. SUH: Okay. 8 DR. FREY: Okay, Judy, and then 9 anyone else? Fred and John.

10 DR. GRAHAM: I had a few comments 11 on the exposure side and its linkage to the 12 health. The first comment is on page 19. 13 This is the area where it says you're going to 14 be doing exposure modeling for 3, 6, 9, 12 15 urban areas, depending upon resources. And I 16 thought you had good criteria for how you 17 would select them in case you don't have the 18 money to do all 12. 19 I think that you should state even 20 in your plan why -- can all these criteria be 21 met with just three areas? Because if you 22 want to meet your criteria, suppose it takes

### 202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 four areas no matter what. I think that 2 should be clearly stated so you don't really 3 have an option for prioritization. You know,

4 there'd be a threshold there. 5 My other concern, perhaps a 6 greater concern, is Zach was talking about 7 doing a health assessment for 12 urban areas. 8 And I thought, "That's terrific. Twelve here, 9 three here." So, maybe that's a clarification 10 point. I mean, how can you do a health 11 assessment on 12 urban areas, if there's only 12 been an exposure assessment on three? 13 DR. PEKAR: So, to clarify, you 14 know the epi-based risk assessment that I was 15 talking about is going to be based on exposure 16 surrogate monitor levels. You know, getting 17 sort of a central site kind of representative 18 monitor, or some version of that, that then 19 it's combined with the effect estimates and 20 the baseline incidence rates. 21 What John is talking about is 22 doing the much more detailed moving

### 202-234-4433 Neal R. Gross & Co., Inc. Page 107 1 populations around in a modeling framework 2 through exposure gradients, and in building 3 profiles for a set of modeled individuals. He 4 does not, at this point -- I mean maybe in an 5 ideal world, maybe in the future, we'll link 6 this more detailed exposure with epi, and 7 we'll be able to have a more fused approach 8 towards risk modeling. 9 But right now, they're different. 10 His is not a precursor to my analysis. Not 11 mine, but our analysis. 12 DR. GRAHAM: Okay. In terms of 13 going back to the prioritization issue again, 14 it says in there that you're considering 15 modeling indoor sources of ozone. I presume 16 that you're going to be doing the sensitivity 17 analysis since there aren't that many indoor

18 sources. 19 To a bigger issue: CHAD. I mean, 20 I think the world of CHAD. I mean, I'm 21 basically the first one that ever funded it. 22 So, I think it's a great thing, obviously. My

### 202-234-4433 Neal R. Gross & Co., Inc. Page 108 1 question is to use it for activity patterns 2 today. A lot of the studies in CHAD are 3 before 1990, and I have to worry about even 4 1995, 1998 sorts of activity pattern data, 5 particularly since we're so interested in 6 kids, and activity patterns have changed. 7 I mean, what used to be a kid 8 outside playing is now a kid inside texting. 9 So, I think that there ought to be some sort 10 of professional evaluation as to the relative 11 accuracy of using some of these CHAD databases 12 today. 13 This brings up the ATUS data 14 files. I personally am not familiar with 15 them, but from what you said there, they sound 16 pretty doggone good to me, and looks like it's 17 a big probabilistic sample. 18 And you say you may not consider 19 it -- you may not be able to use it because of 20 resources. Again, if it's really good, if 21 it's had -- there's a lot of metadata, if it's 22 had a high level of QA, if it's probabilistic,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 109 1 if it's high quality, I don't see how you can 2 not use it. 3 I mean, I know your resource 4 constraints are real at your level, and I know 5 even Lydia has problems. But, I mean, there 6 is still pockets of money, and some of these 7 things just have to be done. 8 So, I guess that's my only things 9 on the exposure side. 10 DR. FREY: Okay, Fred. 11 DR. MILLER: Well, Judy and I 12 think alike on a lot of things. So, I'll just 13 re-echo exactly what she said, because they 14 are very valid points, and the aspect of the 15 activity and the focus on children just can't 16 be underestimated because there's absolutely 17 no way that CHAD represents the current 18 activity levels for most children today. And 19 that's a blank buster, okay? 20 I don't think you have established 21 as well as what Judy gives you credit for on 22 the -- if you're only going to do three, how

### 202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 they would be selected. Because for example, 2 I would think that you could take -- you would 3 want to have geographic areas. So, you would 4 take a city from each of three geographic 5 areas, and you take the dirtiest one with the 6 highest population. 7 You don't specifically go into 8 that here. I'm sure that you've thought about 9 it and you have that in mind, but what this 10 really needs to be done at some point is to 11 lay out exactly what your decisions were on

12 that. 13 And in regard to Chapter 2 on page 14 1, line 26, I'm wondering about if a portion 15 of the analyses -- because George brought up 16 about the atypicalness of the recent years and 17 the recession and Ted has mentioned it. Is it 18 possible to take one city, and look at moving 19 averages across time, 2006, '07 and '08; '07, 20 '08 and '09; '08, '09, '10 or whatever, and to 21 carry that forward so that you really can 22 establish how the risk analysis estimates

### 202-234-4433 Neal R. Gross & Co., Inc. Page 111 1 change with air quality. And you'd also get 2 a sense as to whether it's been reduced or 3 increased over time. 4 And so, I'm concerned about not 5 having atypical and picking something when it 6 -- you could be able -- now, it may be that 7 functionally you can't do this because the 8 amount of work required is the same as doing 9 like 12 cities. That's something that you 10 could give me feedback. 11 But to the extent that you can 12 look at, in a given area, how the air quality 13 has changed and then the estimates so that you 14 can see how it moves, it gives us some sense 15 of how confident we are that we're really 16 capturing what's the amount of risk that's 17 really involved, and of course that would also 18 relate as levels have changed. 19 In your exposure analysis part, 20 you talked about the age-specific on page 4-5, 21 and you did piecewise linear fits to the age 22 categories. You forced them to join at the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 112 1 age boundaries, but why not use isotonic 2 regression, and let the data determine where 3 the cut points are? 4 Or, you even -- since you're using 5 this for a mathematical aspect to fit a smooth 6 curve through the entire data, it wasn't clear 7 to me why you need to do it piecewise on those 8 age intervals. And in that regard, I want to 9 bring up the question of -- you were talking 10 about basically around age 8 as the lowest. 11 Why would you think that ozone 12 exposures, and this kind of goes to what Zach 13 would be doing, there aren't data for children 14 exposed to ozone at lower levels than what 15 McDonnell did, and that was around the age 8

16 to 10? 17 But why would you expect that 18 ozone wouldn't affect children age, say, 3 to 19 6 years the same way as they would the older 20 children? And in that way, you could use data 21 that are in the literature. Like I give a 22 reference, Peconi et al., in 2007, where you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 113 1 have pulmonary function data and FEVs for 3 to 2 6 year olds. And so, you could continue this

3 on down. 4 So, I would encourage you to look 5 at that because I think it gives you a 6 spectrum of the population, and if you can't 7 do it, then I think you need to defend why you 8 feel that you can't go below it. Because the 9 relationships appear in terms of a 10 normalization of what Bill McDonnell did to 11 body surface area, where children respond the 12 same as adults in terms of that kind of 13 change. 14 So, I would think there's a 15 normalization you can do that would justify 16 being able to take it to lower levels, and 17 that would increase your overall power.

18 The other area that I -- there's

19 two other areas that I want to comment on 20 right now, and by the way, since I'm always 21 reluctant to give my opinion, whatever you 22 don't receive from me in writing, you can

### 202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 consider that I agree with it. Okay? So, 2 that's a simple way to say I have looked at 3 the entire document. So, I'm giving you my

4 feedback. 5 For whatever it's worth, if I 6 don't point something out here, I think I 7 totally agree with what you're doing. 8 So, one of the things that has 9 bothered me in every one of these assessments 10 is the conflation issue. And one occurrence 11 for 10 people has to involve less risk than 10 12 occurrences for one person. And you have got 13 to find a way to overcome that. 14 I don't see, if you go to a 15 modification and adding data into CHAD, why 16 you can't have a tag identifier such that, if 17 you select that individual and you put them 18 back into the pool, you can keep track of how 19 many times they're selected. 20 So, in terms of the health 21 importance, there's a big difference, and 22 we've grappled around this in previous

### 202-234-4433 Neal R. Gross & Co., Inc. Page 115 1 discussions, but no way to actually hand it. 2 And so, it might be, if you're getting to a 3 transition in terms of database and your 4 sampling, that might be something that you can 5 maybe start to address. I throw that out 6 there because it's always troublesome. 7 The last thing that I want to 8 comment about has to do with your part on page 9 317 about maybe examining averting behavior, 10 if resources are available. And my view is 11 that, don't waste a penny on it, and I'll tell 12 you why I feel strongly that way. 13 Risk aversion is a negative 14 factor. If you take risk aversion to its 15 ultimate, then you're left with letting 16 pollution increase, and we simply have to stay 17 indoors and wear masks and so on. What -- I 18 have failed to understand how, understanding 19 the risks with risk aversion helps us protect 20 people in wanting to be able to do normal 21 daily activities, and not have to when we have 22 orange level alert and stay indoors and that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 116 1 So, maybe I missed what is the 2 contribution of averting behavior can do, but 3 as it stands now, I wouldn't do it. So, I'll 4 stop and I'd really ask you to clarify for me. 5 Maybe I missed how this is going to help. 6 DR. HUBBELL: Well, again, this is 7 an area that has been emerging over the last 8 several years as a study topic in 9 epidemiology. The concern I have going into 10 this, and I think this is one of the reasons 11 why the literature has been evolving, is that 12 we do have an AQI, and we do actually ask 13 people to look at that AQI and respond. 14 So, whether we think it's a 15 positive thing or a negative thing that they 16 have to do this, they are doing it. And the 17 concern I have, and one of the reasons why 18 we're looking at it in the exposure side, as 19 well as thinking about it from the epi side, 20 is that the epidemiological relationship that 21 we see now has embedded in it this response, 22 this behavioral response to the AQIs.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 117 1 So, people are going indoors, 2 potentially engaging in unhealthy activities 3 by sitting in front of the TV, but they're 4 reducing their ozone exposures. And so, you 5 might then see a growing disconnect between 6 the ambient concentrations that are used in 7 the epi studies, and the personal exposures 8 that are really driving whether or not people

9 see an actual effect. 10 So, you can have the unfortunate 11 occurrence that you get a potential observed 12 reduction in the effect estimate that is 13 associated with ambient concentrations that is 14 driven by a reduction in personal exposure, 15 due to averting behavior. 16 That's not something I think we 17 want to attribute to being that ozone has 18 become more healthy for you. What it means is 19 that we've shifted the risk from air pollution 20 to potentially these other behaviors, and 21 there's a cost associated with those. 22 And so, what we want to do is make

### 202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 sure we understand that so that we don't 2 improperly attribute what we see in the epi 3 data to an improvement in the relationship

4 between ozone and health. 5 MR. LANGSTAFF: Yes, and I'd like 6 to say one other thing in response to your 7 comment, and that is it's likely a small 8 effect on exposures.

9 DR. MILLER: I'm not sure that 10 that would be the case if you're taking the 11 at-risk populations. In fact, I definitely 12 don't agree with you. Someone who has 13 pulmonary health considerations, they follow 14 those alerts. People that have children with 15 asthma, they let their kids do or not do 16 things based upon those index -- and I 17 understand now what you're getting at, and I 18 will change my written comments accordingly, 19 because that's part of the reason why I always 20 label my things preliminary, and then you'll 21 get the final. But I see where you're coming 22 from now. Thank you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 119 1 DR. FREY: Okay, great. John, you

2 were next.

3 DR. BAILAR: I had two comments 4 about these two planning documents together, 5 and a couple about this welfare document. 6 First is I think each of these 7 plans should include an explicit statement up 8 front about how EPA will deal with apparently 9 relevant and important information that's 10 published after the release of the final ISA 11 report. 12 It is okay with me to say that 13 you'll ignore any such information, but this 14 should be clear in the report itself. I think 15 also that both of them should say somewhere -- 16 they lay out a minimum in scope and methods 17 and that more will be added if study shows a

18 need for that. 19 With respect to the welfare 20 document specifically, I'd like to see an 21 analysis that is more explicit in examining 22 the roll of co-pollutants as confounders,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 120 1 which could be dealt with by such methods as 2 modeling standardization or stratification 3 versus co-pollutants that may act in synergy 4 with ozone, which cannot be dealt with that 5 way. 6 And finally, I think that the 7 welfare document should say that there are no 8 other known welfare issues, or say what is 9 being omitted. 10 DR. FREY: Okay, good. Other -- 11 yes, Ed? 12 MR. AVOL: I just want to follow 13 up on something Fred said. I also had 14 problems with the conflation issue and the 15 APEX on page 3-8, and my issue is slightly 16 different. We learned in elementary school 17 that multiplication is commutative; that one 18 times ten equals ten times one. But I think 19 it doesn't here, and it doesn't here because 20 of the issue -- among other things, because of 21 the issue I raised yesterday, which is that of 22 attenuated responses.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 121 1 So, repeated exposures for some 2 people they behave differently. And somehow, 3 that is not going to get translated from the 4 exposure here to the health risk, if you just 5 take that commutative property.

6 DR. FREY: Good. Other comments 7 on exposure analysis issues? Yes, Peter? 8 DR. WOODBURY: I guess just a 9 question. This isn't my area, that is the 10 human exposure, but I just had a question 11 about the discussion of changes in behavior of 12 children, and my question is should we be 13 considering what other portions of the 14 government might be recommending in terms of 15 children's activity levels? 16 We have a problem with obesity, 17 and we want children to be active. So, it 18 obviously makes sense to look at how 19 children's behavior has changed over time. I 20 guess my question is does it also make sense 21 to look at what is being recommended in terms 22 of children's activity levels?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 DR. FREY: Yes, good. Anyone want 2 to pick up on that? I mean it seems like in 3 a way that's almost an analogous to the 4 avoidance discussion that from a public health 5 perspective, if we were to model avoidance 6 into the exposure assessment, that might 7 actually bias the assessment. 8 If it's a normative issue to 9 promote outdoor activity from children, maybe 10 it's appropriate to use data that 11 overrepresents that, even though that's not 12 the current -- it seems like that's the 13 discussion point. Are there any thoughts on

14 that? Ed?

15 MR. AVOL: CDC recommends 150 16 minutes a week of exercise. It's probably 17 higher for children. 18 DR. HUBBELL: One thing I'll point 19 out on that is that one of the -- an 20 additional benefit of looking at it from the 21 exposure side in terms of averting behavior is 22 that it actually shows that penalty.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 123 1 In other words, if people are 2 staying indoors, and not exercising or having 3 activity because of concern about ozone 4 exposures, and we can identify that, and we do 5 have a survey that we're looking at that may 6 give us some additional information on that, 7 that is a penalty that can be identified, and 8 that can be then matched against these CDC 9 recommendations, and saying, well, these kids 10 are spending 20 minutes or 30 minutes inside 11 more a day, and that means that they're going 12 to have to make it up, or they will not get 13 that benefit as recommended by CDC. 14 So, it does give you that -- that 15 information. 16 DR. FREY: Good. Other -- yes,

17 Helen? 18 DR. SUH: The surveys, aren't they 19 really focused in LA and Houston? I mean so 20 would you expect the same avoidance behavior 21 in areas -- because I mean I know that the AQI 22 gets different attention in different areas.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 124 1 And I know for example Houston and LA are sort 2 of a -- sort of a -- but I'm wondering if 3 there's data for other areas that perhaps

4 don't have that same -- 5 DR. PEKAR: Certainly the NCES 6 survey that was completed recently and that 7 we're pulling data in depending on time and 8 resources focused on a larger number of cities 9 across the country. 10 So, it had a larger set of 11 responders. Although I'm not sure that -- my 12 recollection, which I should know off the top 13 of my head, is that we did not cover children 14 within that particular survey. I want to say 15 that it was adults 18 to 55, I think. I'm 16 looking at Susan. Maybe she remembers. 17 Thirty-five and up, thank you. 18 MR. LANGSTAFF: But you're right; 19 it's city-specific. I think that study looked 20 at five cities. 21 DR. SUH: I think it might be an 22 important thing in some places, but perhaps in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 125 1 others, it's -- 2 DR. HUBBELL: Yes, and we've seen 3 that in the epidemiology as well that you see 4 a bigger response when you're -- you see a 5 bigger response in places that are more 6 familiar with ozone episodes and have more 7 ability to react in ways because they can go 8 inside with the air conditioners.

9 DR. FREY: Ed? 10 MR. AVOL: Full disclosure. CDC 11 recommends 150 minutes a week of physical 12 activity for all of us, not just children. 13 DR. HUBBELL: Running after our 14 kids, for some of us.

15 DR. FREY: Fred? 16 DR. MILLER: I was curious. On 17 page 4-1, line 18, you talk about doing 18 analyses with asthmatic school children. Do 19 you already have the lung-function data 20 available for those kids? And if not, where 21 are you going to get it? Because I sure would 22 like a copy.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 126 1 MR. LANGSTAFF: No, I don't have 2 it, and I'm not sure if it's available. If it 3 isn't, then we can't really do it. 4 DR. MILLER: And I don't think it 5 is, but I mean clearly the ATS is the -- there 6 are people there to contact to find out, but 7 in the different modeling that I do, I'm 8 always looking for these kinds of subgroups. 9 I have stuff for COPD individuals and how 10 their mucus flow rates change, and things of 11 that -- and the affect of the amount of ozone, 12 and the affect of the amount of particles and 13 that. But you've brought up a very important 14 group in terms of the asthmatic attacks and 15 the children. 16 So, to the extent that you can 17 track down that data, it would be great. I 18 just am not aware of any. But again, I've 19 sort of been out of touch. Ed, you might

20 know. 21 MR. AVOL: I don't know of it 22 being grouped in that way, but there is --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 127 1 there certainly is some data. 2 DR. FREY: Okay, anybody else? I 3 guess one observation is, I was one of the 4 discussants on the ISA chapter 4 on the 5 exposure, and I don't recall seeing really 6 anything specifically about BenMAP in that 7 chapter. And maybe this is really more for 8 NCEA than it is for OAQPS, but I guess having 9 a foundation in the ISA that supports the use 10 of BenMAP would be useful, and I may have 11 missed it if it's somewhere else in the 12 document. But just wanted to mention it since 13 I know John Vandenberg is in the room. 14 DR. HUBBELL: And it's not an 15 exposure model, to be clear. So, it really 16 doesn't belong in an exposure discussion. It 17 really is as a risk framework -- 18 DR. FREY: Yes, well, there was 19 some discussion in that chapter on 20 concentration fields over space and time, and 21 it seems like BenMAP -- that's a component of 22 what BenMAP addresses. And so, the methods in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 128 1 BenMAP as it pertains to that would certainly 2 be appropriate in Chapter 4, and then perhaps 3 some of the health related aspects of BenMAP 4 ought to be dealt with in some of the other 5 chapters in the ISA, which I didn't review. 6 So, I don't know that it isn't there. But I 7 just wanted to encourage that linkage. 8 DR. FREY: Any other comments? 9 I'd like to take a quick break. Are there any 10 other comments from the panelists on the 11 phone, John Samet, Kathy Weathers, on exposure 12 issues before we break? 13 DR. SAMET: This is John. 14 Nothing.

15 DR. WEATHERS: No. 16 DR. FREY: Okay. Let's take a 17 nine-minute and 59 second break, and we'll

18 reconvene at 10:40. 19 (Whereupon, the foregoing matter

20 went off the record at 10:31 a.m. and resumed 21 at 10:42 a.m.) 22 DR. FREY: Okay, I'm confident

### 202-234-4433 Neal R. Gross & Co., Inc. Page 129 1 that everyone will find their seats 2 momentarily. What I'd like to do, my goal is 3 to try to get a little bit ahead on the agenda 4 because many of you have to leave a little bit 5 earlier than the scheduled adjournment. 6 So, EPA is on notice that if we 7 get through the health risk assessment issue 8 discussion on the health scope and methods 9 plan that they're ready to go on the welfare 10 scope and methods plan presentation before 11 lunch. So, that's my goal is to try to get us

12 there. 13 The discussants on the health risk 14 assessment issues are John Bailar, Fred 15 Miller, Judy Graham and Michelle Bell, and all 16 are present. So, I'd like to go ahead and get 17 started with that, starting with John Bailar.

18 DR. BAILAR: I've found over the 19 years that it's much easier to critique a good 20 document than one that is lousy. If it's 21 really bad, you can dismiss it in a few 22 sentences, but if it's really good, things

### 202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 just keep tumbling out. 2 In that context, I have four pages 3 of comments that are meant to make a really 4 good thing even better. I'm not going to go 5 through all of these because you have them in 6 writing, and I'll only mention the ones that 7 might raise some issues for discussion. 8 DR. FREY: John, could you move 9 the mic a little closer? 10 DR. BAILAR: Better? Okay, I'm a 11 little concerned about the use here of data 12 from volunteers, which are generally drawn 13 from local residents. They may therefore 14 carry the effects of any prior exposures with

15 them. 16 I'd be pretty cautious about 17 assuming that a person with past exposures to 18 substantial levels of ozone or other 19 pollutants would respond just like a person 20 without that exposure, and I would not want to 21 guess which direction such an affect, if any, 22 might go.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 131 1 Spatial and temporal heterogeneity 2 within an area raises issue quite different 3 from such heterogeneity across areas, and this 4 could use some discussion. 5 I'd like to see more about -- in 6 Table 3-2 about how study participants were 7 selected. This was a table listing some 8 studies. I'm a little concerned about 9 possible bias, and the first bullet on page 10 316 does not really address the problem of 11 non-representativeness within specific 12 categories, or demographic descriptors. 13 The survey statisticians quite 14 broadly recognize that anything short of 15 random sample with a high response rate may be 16 seriously biased. 17 You say that several activities 18 will be undertaken if sufficient resources are 19 available, but what is the priority ranking of 20 these if you can do some but not others? This 21 seems to require some thought now, rather than 22 later; when you know what the resource

### 202-234-4433 Neal R. Gross & Co., Inc. Page 132 1 limitations are, you might not have enough 2 time to get it properly sorted out. 3 I'm concerned, as others are, 4 about the selection of urban areas for study. 5 That's an important aid to understanding the 6 proposed plan. I remain concerned about the 7 use of 12 urban areas to represent the entire 8 urban population of the US. 9 These 12 should be examined 10 separately and compared. I think you plan to 11 do that. Only if they are in pretty good 12 agreement should they be combined into a 13 national figure. But I do not see a 14 description of this critical comparison, 15 including criteria for judging whether they 16 are sufficiently similar to provide a reliable 17 combined estimate. 18 If they are not sufficiently 19 similar, reasons for differences should be 20 sought and to the extent possible the effect 21 of differences should be estimated. 22 This could be in the form of a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 133 1 sensitivity analysis, or perhaps by allocating 2 each US city to a category that closely

3 matches one or more of those areas. 4 I understand you may not be able 5 to do 12 areas, but I would recommend at least 6 6 that are deliberately chosen to provide 7 variety because of the need to understand both 8 the degree of variation and, to the extent you 9 can, the determinants of variation. 10 It's not clear to me how you're 11 going to select the modeling elements that 12 you'll take as core, versus those for the 13 sensitivity analysis. If you're going to make 14 the selection after you look at results, say 15 so with some comment on how you will choose. 16 Otherwise give the reader some guidance about 17 your choices prior to analysis. 18 There is a paragraph here that 19 helps, but it doesn't go far enough, given the 20 criticality of this phase of the analysis. 21 I can skip that. I talked 22 yesterday about problems with multi-pollutant

### 202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 models, where things are -- the significance 2 of things rises and falls with other 3 pollutants that are in or out of the model. 4 That is a matter that requires a 5 lot of attention from people who really 6 understand modeling, and the -- the 7 interpretation of the various kinds of 8 coefficients coming out of the models. I 9 don't want to go over all that again, but it's 10 something that is -- really does require a lot 11 of experience and understanding. 12 I'm not a fan of the WHO tier 13 classification because to me, it gives zero 14 guidance to the analyst. The words in the WHO 15 descriptors of tiers are subject to a vast 16 range of interpretations and distortions, and 17 there are no sharp divisions among the tiers 18 anyway. 19 I think it can be useful for 20 describing what was done after the fact, but 21 I suggest that this section be deleted or 22 replaced with a more informative statement.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 135 1 Nature surely does not provide 2 dose response relationships that follow any 3 simple mathematical formula for any 4 heterogeneous population, and this should be 5 said now and then in various places in your 6 document, as well as a lot of other kinds of

7 documents. 8 The goal is purely empirical to 9 find some curve that fits pretty well, and is 10 mathematically tractable. For example, a 11 small recognized subpopulation of acutely 12 sensitive persons can produce a distinct blip 13 in the toe of the dose response curve, such 14 that low dose risks estimated by a linear 15 model are substantially underestimated, or an 16 unknown physiologic mechanism may bend the low 17 dose curve in unexpected ways, like vinyl 18 chloride. 19 With respect to resources, I would 20 give high priority to long-term understanding 21 of real individual responses. It's remarkable 22 that signals related to central monitors are

### 202-234-4433 Neal R. Gross & Co., Inc. Page 136 1 so clear, and I would expect that better 2 information about what people actually inhale, 3 especially indoors, would add a lot to what we

4 know about low dose effects. 5 It would make the signal a good 6 bit sharper. I don't know which way the 7 signal would move, but it would be a lot 8 clearer I'm sure, if you understood much more 9 about what people are actually breathing. 10 Finally, I would pay more 11 attention in this document to mortality, which 12 is more likely to drive any change in 13 standards than physiologic measures or 14 morbidity. Thank you. 15 DR. FREY: Thank you, John. Fred? 16 DR. MILLER: Well, I'll start 17 with, make the problem CASAC's, rather than 18 yours, on a couple of these things. 19 You indicate throughout this 20 document you'd get additional things if 21 resources are available. I strongly urge you 22 to have a strategic priority list, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 137 1 establish it now, but moreover, come to CASAC 2 for a consultation. So, later we can't say, 3 well, why didn't you do so and so? And why 4 didn't you do this and that? That we get the 5 buy in up front. 6 Because you've just identified so 7 many things I think that -- that you'd like to 8 be able to do, but if I'm sensing the mood of 9 the -- well, we won't call whose mood it is, 10 but anyway, I don't think you're going to be 11 able to do as much as what you want, and I 12 think it's very important that you define up 13 front what your base levels are of things that 14 you're going to do, and then how you would add 15 things in and in what order, and have that 16 reviewed and agreed by CASAC because that 17 really makes it much simpler later for you to 18 defend why you picked this versus that. 19 And so, I think this group can 20 sort of be the scapegoat for you. So, that's 21 my reasoning for that, offering that 22 suggestion.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 When you go to the particular 2 health things that you were going to examine, 3 to me, you have enough to do already, and I 4 wouldn't expand to some of the additional 5 health categories that you've discussed in

6 here. 7 For example, to me, the picture is 8 not clear on birth weight, and I guess I would 9 like feedback from the rest of the panel if 10 they really think it is that clear. When I 11 read the material, I saw too many plus/minus, 12 plus/minus, and then this overall statement to 13 say, well, we think it's suggestive, blah,

14 blah. 15 So, I think you have enough, given 16 the resource constraints, that that's just 17 something that should wait a later time for 18 actually trying to incorporate. 19 I feel the same way about the 20 long-term exposure mortality. We have this 21 one study by Jerrett, and the others are 22 plus/minus in that, and I know that mortality

### 202-234-4433 Neal R. Gross & Co., Inc. Page 139 1 will drive the eventual analyses in terms of 2 dollars that Executive Orders require to be 3 done, and I was hoping that the ISA discussion

4 would come down clearer on how well these data 5 are available for prime time at this point. 6 I personally feel that the cases - 7 - if you have to take short-term mortality 8 versus long-term mortality, the case is 9 infinitely stronger for short-term mortality 10 than it is for long-term, and it's not clear 11 to me if CASAC as a group agrees in terms of 12 the long-term mortality that that is worth the 13 investment of your resources. 14 So, it might be something that 15 others on the panel comment and tell me I'm 16 full of it. So, who knows? I agree with 17 placing greater weight on using concentration 18 response relationships that reflect the 19 adjusted single-city estimates obtained from 20 multi-city studies because to me it represents 21 the best of both worlds. And so, I think you 22 have articulated a very good reasoning for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 140 1 your strategy there. 2 I do, however, have a problem with 3 no thresholds. I think you should clarify how 4 you're going to handle risk below however you 5 want to call the term, PRBs, or this 6 apportionment and that. Because you're 7 basically making a policy judgment when it 8 should be a scientific one. 9 I think the science -- personally, 10 I think the science says that there is an 11 effective biological threshold. I'll give you 12 the example, analogous to PM. When I was up 13 at -- I've forgotten the name of the 14 institute. It was on CSPAN, and it was on PM. 15 It was a thing about there's no threshold for 16 particulate exposures. I showed a slide with 17 a single particle on it. I said, if you 18 really buy into this theory a single particle 19 can kill you, I doubled it. I covered the 20 screen with dots of particles, and I pointed 21 out. And each time I would ask, raise your 22 hand if you think that this can kill you. I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 141 1 never got anybody to raise their hand even on 2 the full one, and guess what? I said, that 3 doesn't even represent one microgram per cubic 4 meter of particles. 5 There's got to be an effective 6 biological threshold for most endpoints for -- 7 and what it comes down to is because of the 8 tolerance distribution variability, you can 9 identify usually individual thresholds, but 10 not necessarily population thresholds. But I 11 don't -- I don't agree with adding risk when 12 you're at levels that are ozone exposures that 13 you can't control. 14 I mean it just seems 15 counterintuitive to what we're trying to do. 16 So, maybe this is something that others will 17 weigh in and say no, but I personally endorse 18 an effective biological threshold for ozone, 19 and I think it has clearly been shown that 20 it's somewhere in this -- down in the PRB 21 range. It's certainly not at 60. 22 The reason I say it's not at 60 is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 that yes, the Kim study had adequate power and 2 showed statistically significant, but not 3 clinically relevant pulmonary function 4 changes; however, the PMN influx was 40-some 5 percent above controls at that same exposure 6 level and that is significant. The 7 inflammation aspects of that study are 8 clinically relevant. The pulmonary function 9 aspects aren't. So, you have that. Now, you 10 go down to the 40s, and you basically fade 11 away into the background, and so I think that 12 if it were such that we didn't have effective 13 biological thresholds on most of these things, 14 people would end up dying on a lot more 15 occasions and different things. 16 And so, there is an aspect of 17 homeostasis and the ability of the body to 18 repair itself. We don't have -- in terms of 19 cancer, you have natural killer cells 20 circulating that are knocking off and killing 21 these cells. So, the aspect of using no 22 threshold just is counterintuitive to me in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 143 1 terms of biomedical research. So, I think you 2 got to be clear on how you're going to handle 3 that and defend what you're going to do. 4 You bring up on page 518 about 5 using the ICD-9 to ICD-10, and to me, this is 6 an absolutely must activity that -- and I 7 would suggest that you draw in the main 8 players at CDC now and be able to get that 9 code-change in place. Because it really does 10 affect the strength of the analyses that 11 you're trying to do. 12 I don't know who all read that, 13 but there has been a change in that, and -- 14 and the way you lay it out here, I mean to me 15 it's critical that you're able to use the 16 newer codification. 17 I also didn't quite understand, 18 and I'd ask you to clarify, the cause-specific 19 admissions in ER visits. And the reason I 20 give this -- it's actually a personal example 21 because my wife died a couple months ago, and 22 it relates exactly to why I'm asking this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 144 1 question. And that is what about an emergency 2 room visit, or a hospital admission for 3 pneumonia, but it's really aspiration 4 pneumonia due to swallowing dysplasia from a 5 stroke or others? How -- and that occurs. My 6 wife died of it. 7 How -- you are lumping these 8 together, or are you able to -- is -- is the 9 death certificate and the information that you 10 have specific enough that you can separate 11 those kinds of cases out, because aspiration 12 pneumonia in the elderly is a very common 13 phenomenon. And so, I raise it as to say I'm 14 not sure how you can handle it, or if you can 15 delineate. 16 And I would ask in terms of some 17 of the variance estimation procedures that 18 you're doing, and this is brought out on page 19 519; don't you have sufficient sample size to 20 use asymptotic variance estimates on a lot of 21 these things? And maybe you are doing it, but 22 it didn't come through, and this might be a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 145 1 point for clarification because the document 2 is, you know, at the 30,000 foot level to 3 allow us to understand what you're planning to 4 do, and from that perspective, it's a very 5 good document. But some of these kinds of 6 things, it just will help for you to 7 articulate more what they are. 8 And the last -- well, next to the 9 last, I do want to echo Dr. Bailar's comments 10 about not relying on the tier thing of WHO. 11 Now, Dr. Graham, sitting to my left, has had 12 a lot more experience with the WHO, but I find 13 that usually WHO comes out with something that 14 tries to please everyone and ends up not doing 15 it. 16 Well, maybe not this time but -- 17 well, anyway, I -- I'm reluctant to get into 18 just a step because there's so many different 19 caveats and things. And so, I'd really 20 appreciate more if you'd defend and lay out 21 what your reasoning and logic path was. And 22 if that ends up corresponding to the guidance

### 202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 that they provided, fine. But I wouldn't just 2 say, well, we followed the WHO tier guidance. 3 And the last point I wanted to 4 make is on -- related to the material on page 5 522. And it -- I wanted to ask the question, 6 can you fix the values of these model 7 estimates that don't have enough data, and 8 then incorporate the probabilistic assessment 9 for those elements having sufficient 10 information to assign the probabilities? 11 If I go by what's written there, 12 one would never be able to do a probabilistic 13 assessment because a universe of data would be 14 needed. And so, that might just need 15 clarification, but it didn't come through to 16 me how you were going to achieve that. So, 17 those are my comments. 18 DR. FREY: Okay, thank you, Fred. 19 DR. HUBBELL: If I could clarify 20 one thing?

21 DR. FREY: Sure. 22 DR. HUBBELL: On this issue of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 147 1 emergency room visits -- and we're very sorry 2 for your loss. The way that we do it is we -- 3 we match what's in the epi study, and the idea 4 is that if classification that's used in the 5 epi study, and the classification we use in 6 the risk assessment may both contain the error 7 that you're talking about, but the idea is 8 that the error is going to be the same, and 9 it's just noise added to the overall signal. 10 So, while it may be true that 11 those people are not affected by air pollution 12 in the same way because of the misdiagnosis of 13 the cause of death, it's going to be the same 14 in the epi study, and that noise is going to 15 be the same exact response. 16 DR. MILLER: Yes, it's noise, but 17 at leads to overestimation of the true risk. 18 DR. HUBBELL: But the epidemiology 19 affect estimate also includes that same -- in 20 other words, if there are -- if there are 21 people included in the baseline rate that is 22 being modeled through the epi study, and those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 148 1 folks really are not responsive, it's going to 2 show up in both places. 3 DR. MILLER: Okay, okay. 4 DR. HUBBELL: And the second thing 5 I wanted to get some clarification on is on 6 this question of thresholds and biological

7 thresholds. 8 At this point, our interpretation 9 is that the epi literature would mean that we 10 wouldn't want to apply the -- a function with 11 a threshold. But if were to consider 12 different cut points, in the past, especially 13 for PM when this has been considered, if you 14 are going to apply a threshold when there 15 hasn't been a threshold estimated in the epi 16 function, you have to adjust the slope of the 17 concentration response function to account for

18 the fact that all those observed excess deaths 19 that you actually modeled with the linear 20 function would actually only be occurring 21 above a particular threshold point. 22 So, I was wondering if there's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 149 1 some comment on do you think that that type of 2 an adjustment procedure is -- is appropriate 3 if you're going to put a -- some type of a 4 threshold based on a biological observed 5 threshold in a lab study or clinical study? 6 DR. MILLER: To me, it's quite 7 appropriate. To me, I don't think we've had 8 enough discussion as a panel on this 9 mortality, as well as the threshold's 10 agreement or not. 11 I'm giving you my view, and I 12 thought in the previous assessment that you 13 did not accumulate risk for exposures below 14 the background level.

15 DR. HUBBELL: And that's correct. 16 I mean you're looking at differences. You're 17 looking at risk above different background

18 levels.

19 DR. MILLER: Correct.

20 DR. HUBBELL: But because of what 21 we're doing now in this breakout, the natural 22 background is a small component, and then

### 202-234-4433 Neal R. Gross & Co., Inc. Page 150 1 there's these other elements that we would not 2 want to say there's no risk there. It's just 3 that risk is apportioned between these other 4 sources, and the international and the methane

5 and other sources. 6 DR. MILLER: So, are you getting 7 at fractionating those, and then saying, would 8 you adjust those?

9 DR. HUBBELL: Yes

10 DR. MILLER: I see. 11 DR. HUBBELL: It gets a little 12 complicated, and I'm just trying to -- 13 DR. MILLER: Yes. Maybe -- 14 Michelle, I see you starting to raise your 15 hand. I'm going to punt because I'm -- this 16 is more in the people's exposure area than -- 17 DR. BELL: Yes, we're jumping 18 ahead a little bit because this is one of my 19 comments. I actually thought the use of no 20 threshold was appropriate. I liked it, but I 21 hear what you're saying about really dealing 22 with more than one issue.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 151 1 One is, is there actually a 2 threshold? And the second issue is if there 3 is a threshold, is it below natural background 4 levels? And in the epidemiological 5 literature, that's as far as we can get. Like 6 if there is a biological threshold at 0.000001 7 ppm, from a policy standpoint, I don't 8 actually care. Right? Because we're never, 9 never going to get there. 10 So, my comment on the threshold 11 point I thought it was appropriate to use it 12 because that's what the epi literature says, 13 but we do need to distinguish whether or not 14 you're talking about health risks from ozone 15 levels that are natural background and so on

16 and so on. 17 So, I would suggest breaking it 18 out in that way, and not ignoring that issue. 19 I think if you apply this artificial 20 threshold, other than picking a number out of 21 the air, I don't know what you're going to do. 22 And if you pick a number out of the air, you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 152 1 need to do sensitivity analysis, which is not 2 really helpful because you're just picking 3 multiple numbers out of the air. 4 So, I thought the current 5 approach, I think you need to expand the 6 language on that, as for most of the document. 7 Just get into more detail. But I thought the 8 underlying thought process behind that was 9 fine. And I know that this issue of natural 10 background thresholds is stuff that many of 11 you have already thought about. So, I would 12 just flush that out more. 13 DR. FREY: Looks like there's 14 several people that want to follow on this 15 point. David and John, did you want to say 16 something? Okay.

17 DR. CHOCK: I have a comment 18 actually. Because you're using a non-linear 19 model and we are really addressing a specific 20 urban area. And so, there's our baseline. 21 So, if you want to extrapolate the model 22 results to high concentration and low

### 202-234-4433 Neal R. Gross & Co., Inc. Page 153 1 concentration, you have to base on that 2 baseline to be safe. Statistically it is 3 logical -- it's a logical way to do it. 4 You cannot arbitrarily move it 5 down to the -- PRB level, and then do the 6 extrapolation. So, that's really my concern. 7 You have to base it on the baseline survey 8 that we use, not the extrapolation.

9 DR. FREY: John? 10 DR. BAILAR: With respect to 11 individual thresholds, I think you really have 12 to understand mechanisms before you can make 13 reasoned judgments. What I have in mind is 14 that if ozone acts through some mechanism 15 that's also a product of some other exposure, 16 you may be dealing with a subpopulation that 17 has already reached that threshold before you 18 add any ozone. So, their ozone threshold is 19 effectively zero. 20 That's why you really need to 21 understand the mechanisms in order to talk 22 intelligently about individual thresholds.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 154 1 With respect to a population threshold, my 2 sense of things is that it's the minimum of 3 all the individual thresholds of interest. 4 That's quite apart from the question of 5 whether you can demonstrate such a threshold, 6 where the effective sample size may be tiny. 7 But again, the whole concept of threshold 8 begins to sort of fray at the edges. 9 DR. FREY: Judy? 10 DR. GRAHAM: For virtually my 11 entire career, I've been disturbed by the term 12 threshold because, what's its definition? I 13 think everybody has their own personal 14 definition, and even if you write it down, 15 even if you write it down in the document, 16 people will still impose their personal 17 definition on it. 18 To a degree, a biological 19 threshold is almost a research threshold, and 20 I often point to, in the old days, you looked 21 at pulmonary edema by doing lung weight, wet 22 weight/dry weight. Then it's protein washout.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 155 1 Then it's -- you inject radioactive material 2 and see if it leaks into the lungs. 3 So, you go down and down. Now, 4 there's morphological procedures, and you 5 measure the thickness. So, the threshold for 6 pulmonary edema keeps decreasing. The 7 threshold for -- if you want to call it the 8 threshold for lowest effective level observed, 9 look at human clinical studies. 10 I mean we used to be pretty high. 11 So, we exercised the more extent of the 12 duration of exposure, increase the sample 13 sizes, had more sophisticated measurements, 14 decrease the variability, had better 15 statistics. So, we kept getting -- we keep 16 driving these numbers lower, lower, lower. 17 Threshold for what? Okay, we 18 could -- I mean ozone will break the double 19 bond, the carbon double bond. Well, so? A20 molecule of ozone might break one carbon21 carbon double bond. But is that a -- is that 22 a threshold, or is a threshold mortality? Is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 156 1 the threshold pulmonary function? Is the 2 threshold inflammation? 3 So, people get all confused by 4 this term. And then when you go to an 5 English-speaking person, as opposed to a 6 science-speaking person, the word threshold 7 has still a different definition. 8 See, I like keeping the science a 9 science. If 0.0001 ppm ozone causes an 10 adverse health affect, I'd like to know it. 11 I know that that's like there's no way in the 12 world that you can think about regulating 13 that. I know that's an impractical thing, but 14 scientifically the science is what the science 15 is. 16 And so, we could discuss that. 17 Then you can say, okay, now, here I put my 18 policy on top of it. We have to be realistic. 19 There is this background, because what I see 20 happening is the science is driving the lowest 21 effective concentration lower and lower. 22 The world in terms of precursors

### 202-234-4433 Neal R. Gross & Co., Inc. Page 157 1 to ozone is driving the policy-relevant 2 background up, up, up. They're going to slam 3 right into each other. Not today, but I mean 4 at some point in time, they're going to slam 5 into each other. And then what are you going

6 to do? 7 So, I mean I guess I prefer 8 discussion of it, and maybe you have to have 9 definitions, but this word threshold is just 10 a very, very difficult one to do. If I ruled 11 the world, I'd remove the word from the 12 lexicon. 13 But now where there is a 14 threshold, if you will, there can be a policy 15 definition of a threshold for acceptable 16 effects, a threshold for the definition of 17 adversity. So, you might say that at 0.0001 18 ppm ozone there's a change in FEV1 20 years 19 from now. But a policymaker could say, yes, 20 you're right. We measured that change. But 21 I as the policymaker don't find it to be

22 adverse.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 158 1 Now, we're not trying to define 2 policy here, but I'm saying that policy can 3 draw a line that maybe science cannot draw a 4 line. 5 DR. FREY: Okay, Fred.

6 DR. MILLER: Yes. As far as the 7 probability for a 0.0001 ppm ozone causing an 8 effect, as a statistician, it exists on a set 9 of Lebesgue measure zero. Okay, and you can 10 go look at that. 11 If you don't agree that there's an 12 effective biological threshold, then there's 13 no role for homeostasis. And so, when you 14 take those two concepts, then maybe it's not 15 the science thing, but maybe it has to be 16 defined from policy of what you can do. But 17 I do not endorse adding increments of risk, no 18 matter what the exposure. It is 19 teleologically not even appealing. And I hope 20 I go up, but I'm probably going to go down. 21 So, you know -- so, I'm not sure how you can 22 accommodate everybody's views because I know

### 202-234-4433 Neal R. Gross & Co., Inc. Page 159 1 what Judy is saying, and she's thought a lot 2 about this. But I also know the real world 3 has got to have effective thresholds. 4 Now, determining where they are, 5 maybe, is a problem, but it goes back to the 6 million-mouse study at Pine Bluff. You can't 7 mathematically show a curve that is -- that 8 defines the threshold or improve it anymore 9 than you can that there isn't. 10 So, it's in this argumentative 11 level, but it's got to -- you should be able 12 to identify a level at which exposure says, 13 I'm not going to consider that you're getting 14 additional risk. And the reason that I say 15 this is if you have a lot of the exposures at 16 those levels, you falsely aggregate the risk 17 when it's really not there. 18 And so, that's my concern about -- 19 and I don't know how you solve it. But I mean 20 maybe other people have views about this, but 21 I'm just not willing to give up on it at this 22 point.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 160 1 DR. PEKAR: Just to be clear too, 2 with the PMX risk assessment, one other option 3 that we did was we used the lowest measured 4 level. So, we said when we talked to 5 management about the risk assessment that we 6 had incidence estimates, and we identified at 7 what point an LML had been reached; not saying 8 that the concentration response function did 9 not continue below that, but just that this 10 degree of coverage within epi study gave us 11 greater confidence in being pretty -- having 12 greater confidence about what the function was 13 doing. 14 Not again that that's actually a 15 threshold at that point, but you could focus 16 on that with greater confidence. And so, 17 that's another wrinkle to --

18 DR. HUBBELL: And of course one of 19 the -- ozone concentrations these days go 20 very, very low. So, it doesn't have as much 21 of a practical implication as it does with PM, 22 using the LML.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 161 1 DR. FREY: Good. Sounds like a 2 challenge. 3 DR. BRAIN: I think we probably 4 beat this horse hard enough. I mean it's like 5 automobile safety. Is there a safe limit 6 where there's no injury. You know, it's a 7 gradual function; I think thresholds and other 8 bright lines aren't terribly useful. 9 DR. VEDAL: This is Sverre Vedal 10 here. I just want to put in a plug for the 11 sensitivity analyses that have been sort of 12 trashed. I actually find those to be 13 informative, and I agree with Michelle. I 14 mean you don't want to go hog-wild about that 15 and select a number of them, but I find them 16 actually quite insightful. 17 The way they're insightful is it 18 really determines how much of the risk 19 estimate is actually driven by the information 20 at the lower concentrations. So, I would like 21 to see it. 22 DR. SAMET: This is Jon Samet. I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 162 1 don't like to agree with -- I think you're 2 right on. I mean there's a lot of issues here 3 and sensitivity analysis is the way to go. 4 DR. FREY: Okay, thank you. 5 DR. MILLER: And I would agree to 6 go that way, but that has got to be part of 7 the base resources because it does allow you 8 to separate out what is my area of concern. 9 So, I would defer, and I agree that that's one 10 way to handle it. But that better be part of 11 the base analyses. 12 DR. SAMET: Sure, sure. 13 DR. FREY: Okay, we actually still 14 have to hear discussant comments from Judy and 15 then Michelle, since I assume your other 16 comments were just related to the discussion 17 at that moment. So, Judy. 18 DR. GRAHAM: Okay, a few general 19 comments. I can't help but say that OAQPS, 20 through their staff papers and how through 21 these risk analyses, they've created the gold 22 standard for chemical risk assessment. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 163 1 it's -- there's -- there's just an amazing, 2 rich history there. You guys have big shoes 3 to fill, and I know you know it. 4 I also take note, as I said in my 5 written comments, that you adhere to most and 6 maybe even all of the NRC's committee's 7 recommendations on model being used for 8 regulatory purposes. That is unfortunately 9 exceedingly rare to see. 10 And so, I think I would like to 11 applaud you for that, and I think you ought to 12 pat yourself on the back for that, that that 13 would add credibility to your entire plan to 14 say that you're dealing with that. 15 My other comment about resources: 16 this was actually of all the comments I made 17 on the ISA in this, this was the hardest one 18 to write. I was trying to think about how can 19 I put my attitude about this resource 20 limitations in writing that would be polite 21 enough for people to read. 22 That was a real struggle. I came

### 202-234-4433 Neal R. Gross & Co., Inc. Page 164 1 up with words totally unacceptable, and so you 2 can -- if that was my polite, you can imagine 3 what my impolite was. I know I'm preaching to 4 the choir, but I want to say it anyway. 5 Ozone is one of the very, very, 6 very few pollutants for which adverse effects 7 are observed in large numbers of people at 8 ambient concentrations. That is an oh my god. 9 Our standard now is at three decimal places,

10 0.075. 11 So, when you think about that, to 12 protect the people according to the Clean Air 13 Act, and of course I wouldn't even think about 14 using the words compliance costs, there's a 15 real value in having accuracy. 16 There's a -- and so, penny-wise 17 and pound-foolish comes to mind. How can you 18 not get the resources to do what's important? 19 Not resources for everything, but like I said 20 earlier on the exposure. I mean three cities 21 versus 12 cities. I mean to make a case, and 22 then for the people that control the money to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 165 1 think in prioritization terms from their 2 perspective. 3 You know, don't make you be the 4 only prioritizers here, but have higher levels 5 of management do the priorities, and think 6 about public health risks and the value of 7 being more precise, and that's where you guys 8 are going. 9 A few specific comments. Most of 10 mine were on the exposure side. On page 4-4, 11 again, you get into this resource limitation 12 about perhaps being able to use or not use 13 Bill McDonnell's 2010 paper. 14 So, I mean I don't want to twist 15 your arm, but I'm saying if that brings value 16 to the analysis, then you almost have to do 17 it. You mentioned you were going to use the 18 Kim data. I don't think that's clearly laid 19 out in here, but -- so, you're finding ways to 20 incorporate some of the newer human clinical 21 data into your sophisticated analysis. 22 My concern is you guys are really

### 202-234-4433 Neal R. Gross & Co., Inc. Page 166 1 working very, very hard, and you're going to 2 come up with something that's quite beautiful. 3 And then, I or someone else is going to shoot 4 you down by saying, but you didn't use the 5 McDonnell data. So you have all this work, 6 and so you have to -- you have to also, just 7 like a physician might practice defensive 8 medicine, you have to practice defensive -- 9 defensive regulation. 10 And so, there's some of these 11 resource things where you know it has to be 12 done scientifically. I mean just, good luck 13 to you. That's it. 14 DR. FREY: Okay, thank you, Judy. 15 Michelle? 16 DR. BELL: So, overall, I thought 17 this document was very nice. One of the 18 comments I have is I think it's really useful 19 to define short-term exposure and long-term 20 exposure in this document. 21 This document actually did better 22 than the ISA in that there was an attempt to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 1671 define it. There's a typo. You say short2 term exposure is greater than 24 hours. I 3 think you mean less than or equal to 24. 4 But that definition that's used 5 does not match -- let me correct the typo. It 6 does not match what's in the ISA. So, I 7 really liked that there was an effort to 8 define it, but it needs to be more flushed 9 out, and it needs to match what's in the ISA. 10 Otherwise, it's just going to be a big mess.

11 And I wanted to comment on some 12 things that I thought were appropriate that we 13 were specifically asked to think about. And 14 one was the use of the fused modeling output 15 with the monitor data, and whether or not that 16 was appropriate, and EPA is considering that. 17 I think that's very appropriate. 18 I think that's preferable to using 19 the model data alone. I think that should be 20 one of your many different types of analyses 21 where you don't supplant using model -- excuse 22 me, don't supplant using monitor data alone as

### 202-234-4433 Neal R. Gross & Co., Inc. Page 168 1 well. But I thought the idea of using the 2 fused monitor model data was appropriate. 3 I also thought having sensitivity 4 analysis to include some health outcomes for 5 which you have maybe suggested causality but 6 not as much certainty, I thought that was 7 appropriate to include as a sensitivity 8 analysis. 9 I'm not so sure about the birth 10 outcomes endpoint, which has been mentioned. 11 The drawn pregnancy outcomes in ozone is 12 pretty uncertain, much more than it is for 13 particles. And some people argue even that's 14 uncertain. So, I think you may be pushing it 15 a little too far to include that health 16 outcome, but I like the concept of including

17 those. 18 In terms of BenMAP, one of the 19 questions was is BenMAP appropriate to use. 20 I think it absolutely is appropriate to use. 21 I think it is definitely the way to go. I 22 think the write up of BenMAP in this document

### 202-234-4433 Neal R. Gross & Co., Inc. Page 169 1 needs to be changed. Because if you read the 2 document, it talks about how with BenMAP, we 3 can produce this and with BenMAP, we can 4 accommodate this analysis. 5 Every single one of those things 6 you could've done outside of BenMAP. You 7 could've done it before BenMAP existed. So, 8 I think that you definitely can use BenMAP, 9 but I think you want to -- I mean there's no 10 reason to misportray BenMAP. It's pretty 11 great as-is. 12 So, I think that you want to --

13 one of the comments Zach made was that BenMAP 14 has gone through peer review, and eliminates 15 more possibility for making errors, and so on. 16 I think there's a way to kind of 17 word BenMAP in that framework. And what you 18 really mean is you can do things really 19 efficiently and completely in BenMAP, rather 20 than having to reinvent the wheel. So, I 21 would just reword the BenMAP discussion in 22 that framework to avoid confusion.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 170 1 Thresholds we've already gone 2 over. I got a little concerned over all the 3 different sensitivity analyses that are going 4 on, like you're going to get distributed lag 5 models. Well, that's great. You're going to 6 look at the covariants in the models. That's 7 great too. But it kind of started to seem 8 kind of kitchen sink to me, like, "We're going 9 to throw in everything." 10 There were two problems with that. 11 One is that you're not going to have all this 12 flexibility. It's not like you're choosing 13 among millions of concentration response 14 functions. Therefore, you can take the one 15 that meets all of these criteria. 16 So, it wasn't laid out in the17 document what you're going to do if the short18 term mortality estimate doesn't meet all those 19 criteria, but the hospital admissions for 20 respiratory causes does. You know, and how 21 that's going to work. 22 And as a second example, I think

### 202-234-4433 Neal R. Gross & Co., Inc. Page 171 1 you may be adding in a bit too much. I liked 2 almost all of them, but just to pick on one, 3 you talk about the models that you use 4 interaction term between ozone and 5 temperature. We understand that. And the 6 models that did that, they just threw it in. 7 I mean they're -- to just throw in 8 a variable for interaction between temperature 9 and ozone, knowing the relationship between 10 temperature and ozone, I mean doesn't -- isn't 11 -- it is very different to interpret. And 12 just because something is mathematically 13 possible doesn't mean it's always a good idea. 14 So, I think again I appreciate the 15 effort to try to be inclusive, but I think you 16 may be pushing things too far on the 17 sensitivity analysis, and I'll give that as 18 one example of something that I would omit 19 entirely. 20 I don't think you need it. You're 21 not going to have it for almost any health 22 outcome; you'll have it for some. But I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 172 1 would just give careful thought -- recommend 2 giving careful thought to all of them to say 3 which ones do -- which ones do I really want 4 to include, and which ones do I not? And I 5 think you'll eliminate at least maybe one or

6 two of them. 7 Just two more points on the city 8 specific analysis. I think there needs to be 9 not more thought, because I know you've done 10 the thought, but more discussion of what 11 really does this mean. Because the way I read 12 the document, you're going to take the 13 locally-derived studies where possible, and 14 then the rest of the cities you're going to 15 fill it in. 16 So, that means you're going to 17 have different -- different concentration 18 response functions from different study 19 designs, from different authors applied to 20 different cities, if I'm reading this 21 correctly. That's not directly comparable in 22 the same way.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 173 1 The local study may not be the 2 best study. But I do appreciate the need and 3 desire to try to get in some of these 4 community specific factors that modify the 5 effect. So, if you are going to do it, I 6 think that it is -- definitely want to go for 7 the Bayesian estimates and not the maximum 8 likelihood estimates, which is what is planned 9 in the document. But I just want to really

10 endorse that for sure. 11 I think you need to give more 12 thought -- maybe not more thought, but more 13 discussion to what are you going to do if the 14 Bayesian estimate is negative, but the overall 15 negative is overwhelmingly positive? Are you 16 going to put in that ozone is protective or 17 not harmful in this city? Because that's what 18 you're saying you're going to do, and so -- 19 and maybe you are, but I would like to see 20 more discussion of that. 21 And my final points goes to the 22 ICD codes. We actually recently did an

### 202-234-4433 Neal R. Gross & Co., Inc. Page 174 1 analysis where we weren't trying to 2 investigate ICD codes, but we found people are 3 really not consistent on their ICD codes at

4 all. 5 Like even if you look at hospital 6 admission for pneumonia or hospital admissions 7 for COPD. There will be like five or six 8 different sets of ICD codes that people use. 9 They'll be overlapping, but they won't be 10 exact. And so, the way I read the document 11 and also from Brian's clarification, you're 12 going to match the ICD codes in the incidence 13 codes to the ICD codes in the epidemiological 14 study, which I think sounds great, but what 15 are you going to do if they differ? 16 So, like in Detroit, you have this 17 set of ICD codes, and then in Atlanta, you 18 have a different set of ICD codes to define 19 COPD hospital admissions. 20 It's starting to become a problem, 21 and you're stuck with what the epi studies 22 did, but I just think that -- I mean it's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 175 1 amazing. You'll read lots of studies and meta 2 analyses that don't even recognize that this 3 happened. And I'm not suggesting that it 4 would change the overall estimates a whole 5 lot, but it does matter. It's an additional 6 level of uncertainty. 7 So, that was something else that I 8 think should be thought about. And that's all 9 my comments. 10 DR. FREY: Okay, thank you, 11 Michelle. Other comments? Fred? 12 DR. MILLER: Following up on what 13 Michelle said about the McDonnell, I would not 14 even do the -- use the resources to compare it 15 to the old. I would just fit the McDonnell to 16 the additional data. Because it's clearly a 17 more defined model, and able to cover a number 18 of different factors. 19 And so, why do you feel like you 20 have to justify and compare it to the old? 21 So, it just is, to me, an area that you could 22 say this is a newer model. It fits more

### 202-234-4433 Neal R. Gross & Co., Inc. Page 176 1 different scenarios, and we're going to refit 2 it in the sense of lowering the exposure data 3 that are now available in that. But the 4 overall functional form of the model is very 5 powerful, and is defensible. 6 So, save some of those dollars and 7 time. Now, if it's just a matter of going off 8 tonight, and punching the button and the 9 computer does it all, that's a different 10 story. But I have a feeling that none of the 11 analyses that you guys are going to have to do 12 are so simple.

13 DR. FREY: John? 14 DR. BAILAR: A 30-second tutorial 15 on modeling. We all tend to think in terms of 16 linear models. There are a lot of reasons for17 that. Linear models are simpler than non18 linear models. Most of the theory has to do 19 with linear models. Our computer programs are 20 set up to deal with linear models, but if 21 there's a curvilinear relationship, that can 22 cause all kinds of havoc. It can create or

### 202-234-4433 Neal R. Gross & Co., Inc. Page 177 1 hide evidence of covariance of synergy. It 2 can expand generally, though rarely contract, 3 confidence bounds. It can do a lot of other 4 things. 5 So, before you use linear models 6 for any of this, and I'm talking not just 7 about this but EPA generally and the world in 8 general, before you apply a linear model, you 9 should look at the data to see if things 10 really look linear. And if not, there are 11 ways around that. 12 You can put in non-linear terms 13 like squares and cubes. You can stratify and 14 look at different pieces of data. There are 15 a lot of tricks you can use to get around it, 16 but if you make the fundamental mistake at the 17 beginning of creating non-linear data as 18 linear, you can end up wrong. 19 DR. HUBBELL: I wonder if I might 20 be able to respond to one thing that Michelle 21 said about the negative estimates. We haven't 22 laid it out in here, and we're all

### 202-234-4433 Neal R. Gross & Co., Inc. Page 178 1 investigating it and evaluating this, and my 2 colleagues may or may not want me to go into 3 this yet. 4 But in the global burden of 5 disease process that's going on right now, 6 where they're trying to develop concentration 7 response relationships for a number of 8 different endpoints, one of the things we've 9 moved towards, and I was a big supporter of 10 this, so I'm curious to see what the reaction 11 is, is we don't -- when we do our estimation 12 of traditional epidemiological models, we're 13 using normal priors. 14 Basically, we're allowing the 15 parameters to be normally distributed, without 16 any truncation of zero, regardless of 17 biological plausibility. What we're doing now 18 in the -- and that may be appropriate because 19 of the hypothesis testing process, but in 20 terms of risk applications, what we're now 21 doing in the global burden of disease study is 22 to refit a Bayesian adjusted concentration

### 202-234-4433 Neal R. Gross & Co., Inc. Page 179 1 response relationship with a non-negative 2 prior. 3 So, basically, you're assuming 4 that you -- you know, it's not biologically 5 plausible to go and have a positive effect of 6 ozone or a PM on health, and therefore you are 7 truncating it at zero, and refitting the 8 distribution. 9 In our case, we're using a gamma 10 prior, but the point being is that it allows 11 for a lot of weight to be put at zero, but it 12 doesn't allow you to go negative. And my 13 question is whether this is something that the 14 Panel has any thoughts on, as a way to try to 15 get around this issue of negative numbers. 16 DR. BELL: I think it's 17 appropriate for global burden of disease. I'm 18 not sure it's appropriate here because these 19 processes have different goals. I mean global 20 burden disease is not a regulatory process, 21 although it might get used in that way. So, 22 I agree with you for global burden, and you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 180 1 may notice I didn't complain about it then. 2 So, I think that's good. I think 3 here it's starting to get dicey. Because 4 you're saying, "I believe this part of the 5 science, but I don't believe that part of the 6 science." And I think kind of conceptually it 7 makes sense, but I mean I think -- I think it 8 will be perhaps perceived and portrayed as 9 that you're picking and choosing the science. 10 "Well, these show an effect testament, so I'll 11 pull them out. And these don't, so I'll move 12 those numbers up to zero."

13 I don't know that we can -- can do 14 that in a justifiable way. I mean I think 15 conceptually it's fine, but I think that this 16 is going to be the gold standard. This is 17 going to be -- has to be so defensible. And 18 if the effects are real, we don't have -- you

19 don't need to do that. You don't want to do

20 that. 21 And so, I think it's starting to 22 get to a slippery slope, where you're picking

### 202-234-4433 Neal R. Gross & Co., Inc. Page 181 1 and choosing. I certainly wouldn't want 2 people to decide how problematic environmental 3 exposure is to human health by picking which 4 study is based on, "Well, this is the one I 5 believe, and this is the one I don't believe." 6 And that's what it sounds like to me in a -- 7 in this context, not for global burden of 8 disease. 9 I mean I just don't see how you're 10 going to say, "This is the overall effect that 11 we believe that includes these negative 12 estimates, but I don't believe them." That's 13 why I believe the overall effect. I have a 14 lot more faith in the multi-city estimate than 15 I do in the individual estimates, even the 16 individual Bayesian estimates. 17 You have to have a little bit. 18 You have to have a lot. But pointing to the 19 Bayesian estimate, versus using the MLEs, and 20 I think everybody's on that page, which is -- 21 DR. HUBBELL: You're saying you 22 don't want go full Bayesian? Because the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 182 1 Bayesian prior -- this is what everybody at 2 the GBD study basically said is, "Well, we're 3 not coming to these evaluation of these 4 empirical data with no knowledge. We don't 5 have any biological studies that suggest that 6 it's actually good for you." 7 In other words, it's bringing in 8 the clinical knowledge that says -- 9 DR. BELL: Okay, well, let me give 10 it to you another way. So, if the affect 11 estimate for the individual city, the Bayesian 12 estimate is higher, are you going to pull it 13 down? Higher than the overall average, are 14 you going to pull it down? And you're not. 15 You're saying. 16 DR. HUBBELL: No, because the 17 gamma function allows for those tails. 18 DR. BELL: Because you designed a 19 statistical function that picks and chooses to 20 say, "I don't believe the ones on the low end, 21 but I believe the ones on the high end." And 22 we can go round and round about this, but I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 183 1 mean my personal view is that it starts to 2 become a slippery slope, and it looks like 3 you're picking and choosing. 4 I guess my view is I want the EPA 5 to be much more technical and defensible than 6 global burden, which as you know is a 7 different goal. So, I think it's appropriate 8 there, but I mean I think it's starting to get 9 into dangerous territory here because I mean 10 the fact that we build a function around it, 11 like we're picking and choosing, and you're 12 not saying that the effect estimate for a city 13 shows -- the Bayesian estimate is much higher 14 than my overall estimate. You're going to use 15 it.

16 DR. HUBBELL: Yes. 17 DR. BELL: You're not going to 18 say, "Well, I'm going to shrink all of them. 19 I'm going to pick and choose." I mean they're 20 all shrunken a little bit, but you're not 21 saying that one is wrong. You're just saying 22 the one at the low end is wrong.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 184 1 So, if you believe the average, 2 and you believe the high end, you can't say 3 you don't believe the low end. 4 DR. HUBBELL: It's actually not 5 saying that exactly, but if you -- what we're 6 saying is -- 7 DR. BELL: It is. 8 DR. HUBBELL: Okay, well, let me 9 just -- 10 DR. BELL: You designed a 11 statistical function so that we can - you know 12 have that function mathematically pick and 13 choose for us, but you designed the function 14 based on priors that we decided. We decided 15 that zero -- like that number -- we picked

16 zero.

17 DR. HUBBELL: Well because 18 biologically -- there's no plausibility for

19 that. There's no -- there's no reason to 20 bound the upper end based on the clinical 21 studies. 22 DR. BELL: Well, this is why I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 185 1 have more faith in your overall estimate than 2 I do in the -- in the individual estimates. 3 Anyway, so, that's my view. These are the 4 type of -- if I thought of it, five other 5 people are going to think of it. So, these 6 are the types of issues I think you want to 7 make sure is as defensible as you can in terms 8 of whatever you choose. 9 And I believe that the approach is 10 not to throw away the overall estimate, but to 11 do multiple approaches. So, if you are going 12 to do locally derived estimates with the 13 Bayesian, you could also do your house, the 14 multi-city overall as well. So, you're not 15 throwing it away. 16 DR. MILLER: I'm not a skier, but 17 this is a slippery slope to me that is a very 18 logical one. Anyone who argues that exposure 19 to ozone is good for you -- 20 DR. BELL: That's not what anyone 21 is arguing. 22 DR. MILLER: Well, no, you're

### 202-234-4433 Neal R. Gross & Co., Inc. Page 186 1 basically saying you got to take the negative

2 of that and -- 3 DR. BELL: No. I'm saying that if 4 someone is going to say, "I'm throwing out 5 these," they have to -- they are picking and 6 choosing. And you need to have a 7 justification for that. If a justification 8 says, "I believe that ozone is bad for you," 9 then you're going to fit a mathematical 10 function to adjust the ones that you think are 11 wrong because you think they're wrong. 12 DR. MILLER: They're not adjusting 13 them. They're counting them with weight zero. 14 DR. BELL: That's how you're 15 adjusting them. 16 DR. MILLER: Yes, and it's 17 perfectly logical. It's the same way as if 18 you take your argument to the extreme. Let's 19 take the ATS's decision about the -- anything 20 not greater than 10 percent is just not 21 clinically relevant. You know? You can go 22 anywhere on this stuff.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 187 1 You have to at some point in time 2 use your judgment about what you think is

3 real. 4 DR. BELL: That's right, and my 5 judgment is I think the overall effect 6 estimate has more certainty than the 7 individual city-specific estimates. And 8 that's my judgment. So clearly, EPA is going 9 to do what they're going to do. 10 This is what they're done before, 11 this type of thing -- 12 DR. MILLER: That's fine. But 13 they weren't saying that they weren't going to 14 compare it to the overall. They're saying 15 this is one of the analyses that they want to 16 do to see what affect it has. That's what I

17 understood. It wasn't that -- 18 DR. BELL: No, I exclusively said 19 that. They're going to do the multi-city as

20 well. 21 DR. MILLER: Okay, so, there 22 really isn't an argument.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 188 1 DR. BELL: I've already made my 2 point. I don't want to argue my point with 3 you anymore. I don't have anything else to 4 say on it. 5 DR. MILLER: I don't think there 6 was an argument with what they planned to do 7 is what I'm saying. 8 DR. BELL: I think that I had my 9 written comments, and I think that they 10 understand my point, whether it's agreed with

11 or not.

12 DR. FREY: John? 13 MR. LANGSTAFF: I just want to 14 make -- there's an analogist situation. I 15 mean the -- these 12 versions, they have some 16 errors associated with them, and we do 17 measurements. We know they're greater than 18 zero, but sometimes measurements are less than 19 zero because there's a distribution of errors. 20 But if we truncate those that are 21 negative to zero, then we bias the overall 22 average. So, I think that's kind of the thing

### 202-234-4433 Neal R. Gross & Co., Inc. Page 189 1 she's -- that Michelle is talking about. 2 DR. FREY: Okay. Other comments 3 on health risk assessment issues by any other

4 Member of the Panel?

5 DR. ULTMAN: I want to ask for 6 clarification. 7 DR. FREY: Can you use the 8 microphone? Thanks.

9 DR. ULTMAN: I want to ask for 10 clarification. As I read the document, I 11 understood that you're going to be evaluating 12 the risk of the particular exposure relative 13 to the background level by -- by calculating 14 both the risks and then doing some type of a 15 subtraction. Is that right? 16 But couldn't you also do it more 17 at kind of the input end -- at the input end 18 of things? I'm talking about the laboratory 19 studies now. In the laboratory studies you're 20 doing it the same way for the laboratory 21 studies. That's the way the document would

22 seem to -

### 202-234-4433 Neal R. Gross & Co., Inc. Page 190 1 MR. LANGSTAFF: Yes, that's -- 2 DR. ULTMAN: It would seem to say 3 that. I would've thought you would've worked 4 on the response point first before you 5 calculated the risk, and calculate the -- you 6 know, the FEV1 decrement at the exposure 7 condition that you were interested in, minus 8 the FEV1 decrement that is estimated at the 9 background level, take the difference there, 10 and then calculate the -- the risk based on 11 that, rather than go through the whole risk 12 analysis on both of those. 13 Is that -- am I making any sense?

14 I'm not sure. 15 MR. LANGSTAFF: Might make sense.

16 DR. ULTMAN: The reason I'm 17 bringing it up is because of the non-linearity 18 that was brought up by John before. Because 19 if there's a linearity in that process of 20 conversion from decrement of FEV1 to the risk, 21 it would make more sense to do the -- do the 22 adjustment on the decrement first, and then

### 202-234-4433 Neal R. Gross & Co., Inc. Page 191 1 calculate the risk. 2 As you get into the details, 3 you'll -- of doing the calculations, I think 4 you'll see that's -- whether it makes sense, 5 or whether that's something you really can't 6 do. I'm just not sure of all the details of 7 all these -- of the process of how you go 8 through. But you might want to consider doing 9 the adjustment first, and then doing the risk 10 on the adjusted values, rather than trying to 11 adjust everything at the end. 12 DR. FREY: Okay. Yes, Ed?

13 MR. AVOL: One small comment 14 compared to the major discussions that have 15 happened, and this has to do with the 16 assessment of spatial homogeneity of ozone

17 across urban areas. 18 So, say you're going to use this 19 based on FRM monitoring -- we understand that 20 ozone in fact is not homogeneous, certainly 21 not in an urban area because of NO titration 22 near roadways.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 192 1 So, we know there are sort of 2 going to be peaks and valleys, if you will, 3 about the exposure but we're not going to pick 4 that up because of network doesn't allow for 5 that. At the end of that discussion, you say 6 you're going to -- you know, if you think that 7 it's -- that there is substantial spatial 8 heterogeneity, then you're going to somehow 9 enhance by more closer linking ozone levels to 10 demographics, and you're going to undertake 11 some sort of procedure to do something about 12 it. 13 So, I don't know if that requires 14 some clarification, or if you just want to 15 think about that, or rephrase that. But it is 16 a little confusing. 17 DR. PEKAR: I think that's another 18 thing that when Fred was talking about 19 identifying priorities, there are various ways 20 to calculate exposure surrogates when you're 21 dealing with monitor data. 22 So, we've talked internally about

### 202-234-4433 Neal R. Gross & Co., Inc. Page 193 1 a number of different ways. First of all, 2 this is speaking just to the epi based risk. 3 You know, you could take the monitors you 4 have, and look at where the populations are 5 located, where mobility patterns are, and do 6 a weighted aggregate kind of monitor value 7 based on where you think the populations are, 8 not that those monitors still capture 9 necessarily some of the gradients you're 10 talking about. 11 But at least rather than taking -- 12 you know, a composite monitor where you just 13 took an average across the monitors without 14 any kind of weighting, you might weight the 15 monitors by where you think populations are. 16 The problem then is that doesn't 17 link to what was done in the epi studies. So, 18 we have this -- which we were talking 19 internally a little bit about. Do you do your 20 best to get a representative monitor value 21 that represents where people are by weighting 22 monitors, or do you try to match what was done

### 202-234-4433 Neal R. Gross & Co., Inc. Page 194 1 in the epi because that reflected a certain 2 exposure surrogate with its problems? 3 And so, we -- we, you know, are 4 trying to consider that. I think we'll have 5 to see what kind of prioritization we do with 6 some of these efforts and our time. Because 7 these things take time. 8 MR. AVOL: Yes, I think that's 9 perfectly fair and appropriate, but I think 10 that it is a -- going to be a decision about 11 prioritization. I think you have to be up 12 front, and say, "Here's where we are, and 13 here's why we chose to do it." 14 DR. PEKAR: Right. 15 DR. FREY: For those on the phone, 16 Sverre, Kathy, John, any further comments on 17 this topic?

18 DR. WEATHERS: Not from me. 19 DR. VEDAL: Not from me either. I 20 think we're following a template that can be 21 not quite uncomfortable with, at least 22 understand it. You know, it'll work -- I'm

### 202-234-4433 Neal R. Gross & Co., Inc. Page 195 1 sure we'll have other observations. 2 DR. FREY: Okay. 3 DR. SAMET: And this is John. I 4 think I'm a little bit in the spirit of some 5 of the concerns that Michelle voiced, just to 6 support that. I have to step away. I'll 7 probably be back on in a while, I hope. Okay? 8 DR. FREY: Okay, thanks, John. 9 DR. SAMET: Okay, thanks. 10 DR. FREY: All right, any other 11 comments from the Panel? I'm going to make a 12 couple of comments. There are actually two 13 issues I want to address. One is the comments 14 we heard on the WHO guidance, and I should 15 disclose I was on that working group. 16 I'm not going to argue that it 17 should or shouldn't be used, but I did want to 18 give some perspective on it. One is that the 19 notion of a tiered approach to uncertainty 20 analysis that might start with, say, 21 qualitative or deterministic, and then some 22 form of sensitivity and then one or two

### 202-234-4433 Neal R. Gross & Co., Inc. Page 196 1 dimensional probabilistic analysis is really 2 not unique to that document. And there are 3 probably other references that could be cited 4 alongside that, or potentially in place of it. 5 I think EPA has been using that 6 notion in some of the other NAAQS assessments, 7 and typically, as I recall, it has been 8 described as being adapted and not taken 9 verbatim from WHO that -- and maybe the 10 language in this scope and methods plan seems 11 a little more prescriptive in the way that it 12 is talking about using WHO. 13 And so, I think what EPA has done 14 in the past, that the other CASAC panels have 15 generally supported, and so, I'd be a little 16 concerned about having inconsistency across 17 panels in pollutants in how EPA is dealing 18 with the notion of a tiered approach, and I 19 think it's perfectly legitimate for EPA to 20 adapt, or whatever it finds useful in that 21 make use of it. And it's not -- I don't think 22 it's intended to be highly prescriptive.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 197 1 I think it is offered for use if 2 it's -- if it's useful. I understand, I 3 haven't seen it myself, that EPA is in the 4 process of developing some probabilistic 5 guidance related to cumulative risk 6 assessment, and I think that's in draft form, 7 and I have no idea when that will be 8 available. And John Langstaff may know more 9 than I do about all things uncertainty within 10 the agency. 11 But anyway, I think the key points 12 are I don't think that's a unique expression 13 of a tiered approach. And I think the tiered 14 approach is helpful in just explaining the 15 thought process by which EPA decided to do a 16 particular kind of analysis, and I think EPA 17 is free to adapt or modify as they see fit. 18 I think that would be consistent with other 19 NAAQS reviews that CASAC has looked at. 20 So, I just wanted to offer that 21 perspective. And so, I can pause for a minute 22 and see if there's any follow up on that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 198 1 DR. MILLER: I appreciate the 2 clarification because I think it's more a 3 matter of the way it was worded here -- 4 DR. FREY: Yes, I think so. 5 DR. MILLER: -- coming across 6 prescriptive. I mean what you've described 7 and what Judy has told me sidebar here. It 8 certainly allows for adaptive. And I think 9 it was more just how it was written here 10 because your clarification has certainly been 11 very useful. 12 DR. FREY: Okay, good.

13 DR. WOODBURY: Just to add a 14 little bit to this discussion of uncertainty 15 analysis and approaches, and again this is 16 nothing new, but just to make sure it's in 17 this -- added to this context is -- you know, 18 we can all put distribution functions on 19 whatever parameters we want, and we can 20 propagate them. But we're looking for insight 21 here about the implications of the results. 22 So, focusing on the most important

### 202-234-4433 Neal R. Gross & Co., Inc. Page 199 1 variables, whether something's actually known, 2 there's a basis for the distribution 3 functions, or where there's really systemic 4 uncertainty, and something needs to be done to 5 address that. You might not want to fit a 6 function to it. It's a what-if scenario. 7 So, I guess I'm elaborating a bit 8 on Dr. Frey's comments. The other thing is to 9 just really, in my view, keep a very sharp eye 10 on sources of bias and interactions. Again, 11 we can propagate uncertainties, and we can 12 make the bounds as large as we want, but we're 13 really looking for the things that matter.

14 DR. FREY: Yes. That's an 15 excellent point. The other thing I wanted to 16 come back to was just that we've heard a lot 17 of discussion about prioritizing and laying 18 out kind of a road map for what the priorities 19 are, being prepared to make decisions, and 20 Fred Miller even suggested consulting with

21 CASAC on that. 22 I guess I wanted to just point out

### 202-234-4433 Neal R. Gross & Co., Inc. Page 200 1 as a practical matter the first draft REA 2 comes out. I guess it's scheduled for October 3 for a November review by this Panel. Then the 4 second draft REA would come out in May of 2012 5 for a possible July review by this panel. 6 So, that would seem to be the next 7 formal opportunity for CASAC to comment on 8 priorities. On the other hand, if CASAC is 9 commenting in priorities in May, and say it 10 takes a month or so to finalize that, and then 11 EPA needs to get its second draft REA done by 12 October, it doesn't give a lot of time to 13 respond to that. 14 So, I guess I would like to give 15 an opportunity for EPA. Have you gotten what 16 you needed from us today? Is there anything 17 you were hoping to hear from this panel that 18 you haven't heard from that would help you? 19 So, just open for a little bit of opportunity 20 for whatever inputs you're looking for. 21 DR. HUBBELL: Thank you very much. 22 I mean we've really heard a lot of actually

### 202-234-4433 Neal R. Gross & Co., Inc. Page 201 1 very helpful advice so far. I think there's 2 obviously a lot of work to do in terms of 3 taking what you've given us, and matching that 4 with what we thought of as sort of the 5 priority elements that we needed to work with. 6 One area that was mentioned 7 earlier by I think Dr. Miller regarding areas 8 that need more discussion, and that -- one of 9 those is long-term mortality. We talked about 10 thresholds quite a bit, and we've now talked 11 about sort of dealing with negative estimates 12 some, but this question of what do we do with 13 long-term mortality: it is a -- potentially a 14 big hitter in terms of having an impact in 15 terms of discussions about -- about health 16 impacts. 17 Just for disclosure on this, one 18 thing we have seen in our applications to date 19 of looking at long-term mortality functions 20 using the Jerrett study, and there's a paper 21 by -- by Neil Pham and some others within our 22 group that, as estimated, recent conditions of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 202 1 PM and ozone, and what's the health impacts 2 associated with those, and it includes an 3 estimate of ozone related mortality based on 4 the Jerrett study. 5 And one thing we've noted is that 6 unlike PM, when you apply the long-term 7 function -- long-term exposure based function 8 for ozone, you're not hugely greater than some 9 of the bounds of the short-term mortality 10 estimates from some of the existing meta 11 analyses. 12 So, it's not as -- it's not as 13 influential as the different between long-term 14 PM mortality and short-term PM mortality, but 15 it's still important and it represents 16 potential importance because it's a different 17 functional form. It's a different form of 18 exposure that might be different than an 19 eight-hour maximum standard, and that's why it 20 has a great deal of importance to us. 21 It's not just because of the 22 impact, but because of the way it would affect

### 202-234-4433 Neal R. Gross & Co., Inc. Page 203 1 our thinking of the form of the standards. 2 So, we would like some additional input from 3 you on should we be looking at these long-term 4 types of health functions? And if not 5 premature mortality, what else might we 6 consider as a way to represent risk associated 7 with repeated peak exposures or longer term 8 exposures? 9 DR. VEDAL: Brian, just a point of10 clarification. I mean in terms of the long11 term mortality stuff, Jerrett paper, which is 12 the only one out there, I mean you -- the 13 reason for the restricted impact the fact that 14 it's basically COPD mortality? 15 DR. HUBBELL: Yes, and that does 16 have something to do with the fact that it's 17 respiratory mortality rather than -- then all 18 cause mortality. But again, there's some 19 question about how are we interpreting the 20 non-respiratory mortalities associated with 21 ozone. There's some questions about should we 22 be interpreting the cardiovascular deaths in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 204 1 the same way we did the respiratory deaths, 2 and there's -- there's -- I'm not -- I agree 3 with you that that is -- 4 DR. VEDAL: Why would we? I mean 5 there's no evidence of cardiovascular deaths 6 from long-term exposure elevated. 7 DR. HUBBELL: Yes, right. 8 DR. BELL: I think it'd be fine to 9 include as a sensitivity analysis. I mean how 10 far down in uncertainty do you want to go? 11 Like I wouldn't go all the way to birth 12 outcomes, but I might go to long-term 13 mortality. 14 I just think that discussion both 15 in ISA and whatever the results are from this 16 project can include the information on briefly 17 summarizing why these outcomes were not 18 included in the main analysis, or why for that 19 one it's just a single study. It's really not 20 a cohort. I mean it is in terms of health 21 response, but it is not in terms of exposure. 22 We don't have their exposure over

### 202-234-4433 Neal R. Gross & Co., Inc. Page 205 1 their time. We just know where they were at 2 the moment. So, those types of issues I 3 thought would be useful, but I mean to me, I 4 think it's appropriate to include as long as 5 it's not in the base analysis. 6 DR. VEDAL: Well, I mean it gets 7 to issues of, you know, the whole issue of 8 where it buys on our -- our causal framework, 9 right? And then they -- the perennial 10 question is whether we have a risk -- formal 11 risk assessment carried out for things where - 12 - where we don't meet the sort of higher 13 levels of causation. 14 Now, in this case, there'd be an 15 argument that we're doing that. We should 16 probably be doing it for a number of 17 endpoints, where we have the same sort of 18 grading of causation, although I think maybe 19 the mortality and long-term mortality issue is 20 perhaps a little bit of a one off because of 21 its significance. 22 But I've sort of waffled on this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 206 1 one way or the other. You know, whether we 2 want to do a formal risk assessment for things

3 that are lower down on our causal ladder. 4 Just because when you do a risk assessment, it 5 takes on a life of it's own that is perhaps 6 overly influential. 7 But I think I agree with Michelle. 8 I would -- at least in terms of the restricted 9 endpoint that we've been talking about, I 10 think it would be informative. 11 DR. FREY: Yes, Fred? 12 DR. MILLER: Sverre, could you 13 clarify what you said about the Jerrett and 14 the COPD mortality? Was that the -- any 15 respiratory mortality, or was this 16 subclassification --

17 DR. VEDAL: I can't remember. I 18 can't remember specifically COPD or a more 19 general respiratory, but I think even if it is 20 in a general category of respiratory, it 21 probably is driven by COPD. 22 DR. MILLER: Yes, and I guess I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 207 1 have to express my personal bias, since 95 2 percent of COPD is related to smoking. Only 3 five percent of the cases are not. I really 4 would keep this in the supplementary kind of 5 thing, and not elevate it to a full scale risk

6 assessment. 7 DR. BELL: They account for 8 smoking, but I still agree with you.

9 DR. HUBBELL: And on that -- on 10 that particular point, the point that is 11 often made is that it's -- it is deaths in 12 people with COPD. So, it's not necessarily 13 saying that it's the air pollution causing 14 the COPD as much as potentially leading to a 15 premature death in someone with COPD as well. 16 DR. MILLER: I think the 17 sensitivity -- 18 DR. FREY: Other comments? Any 19 other questions from EPA to the Panel? 20 DR. HUBBELL: Just expanding on 21 that, are there others based on everyone's 22 understanding of the literature? Are there

### 202-234-4433 Neal R. Gross & Co., Inc. Page 208 1 other endpoints associated with longer term 2 exposures that we should be considering for 3 the risk calculations, or is it really the end 4 of the discussion about long-term exposures? 5 DR. BELL: Why are you looking at

6 me? 7 DR. HUBBELL: Because you're a key 8 epi person. Because Sverre is on the phone. 9 DR. BELL: Sverre, I'm looking at 10 the speaker. I mean I would actually just sit 11 down with a list of not just long-term, but 12 all the health outcomes the way they've been 13 categorized, causal, likely causal, suggestive 14 causal and so on, and just decide how far down 15 you're going to go on the list.16 If you're going to include long17 term respiratory -- long-term exposure and 18 respiratory mortality, you don't want to leave 19 off something that you said had the same level 20 of uncertainty. So, I would just try to make 21 it consistent, and I would not go all the way 22 down the list to birth outcomes, but I mean I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 209 1 -- that's how I would do it. 2 DR. HUBBELL: One of our issues 3 that we run into with ISA, and again this is 4 not a fault of the ISA, it's just the way it's 5 structured, is that they tend to make 6 statements about causality for broader 7 categories than individual endpoints. 8 So, for example, they'll make a 9 statement about likely causal or causal for 10 respiratory morbidity. Well, that's not 11 exactly how the endpoints are divided up in 12 terms of the epidemiology. And so, it's 13 choosing amongst those is often a very 14 different task because when you say, "Well, do 15 we have sufficient evidence for this one 16 endpoint to determine that it is a likely 17 causal?" And then we don't usually get that 18 kind of advice from the ISA. 19 DR. BELL: And I would choose, of 20 the endpoints that have been clustered, I 21 would choose the one with the strongest 22 evidence to be representative of that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 210 1 category. And I would word it that way, 2 because you're not going to get every health 3 endpoint, right? 4 DR. MILLER: In view of Dr. Frey's 5 clarification about when this first draft is 6 available, it seems like rather than coming 7 back with the -- an immediate prioritization, 8 if in this first round exercise, you are 9 basically going primarily with all of the base 10 things that you feel, and you may make some 11 limited progress on some of the others, it 12 seems like at that point in time would be good 13 to, as part of our meeting, to discuss your 14 prioritization at that point of what you have

15 left.

16 DR. FREY: Yes. 17 DR. MILLER: So, I would modify 18 what I said earlier, because I think that's a 19 good strategy. 20 DR. PEKAR: That's actually 21 exactly what we were sort of thinking.

22 DR. FREY: Great. Are we at a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 211 1 good point with the health scope and methods 2 plan? So, question. We can either break now 3 for lunch, and then I know we lose Daniel in

4 an hour. 5 DR. JACOB: I can be here until

6 1:30. 7 DR. FREY: OKAY. Or, we could ask 8 Travis to present, and he assured me he didn't 9 need a full 30 minutes. At least get that, 10 and if anyone had to pressingly leave, have a 11 chance for some quick comments, and then break

12 for lunch. 13 I'm sort of tempted to go with the 14 latter, unless anyone is really hungry. Okay, 15 well, that's self-policing, because if 16 everyone looks hungry, and someone starts 17 making comments. So, Travis, what do you 18 think? Can you give us a presentation in 20 19 minutes or less? 20 DR. SMITH: Certainly. 21 DR. FREY: Okay, do you want to 22 give it a shot? And by the way, thank you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 212 1 Zach. And I guess Brian and John are still at 2 the table. So, I'll thank you later. And 3 while we're waiting for the video, just a 4 reminder that comments are due June 3rd. 5 So, your revised pre-meeting6 comments, or if you hadn't submitted pre7 meeting comments, but now you would like to do 8 so, everyone is welcome and encouraged to do

9 that. 10 DR. HUBBELL: Holly, do you have 11 the slides? Because we can pull them off and 12 put them on there. Travis didn't realize he 13 was supposed to bring a jump drive. 14 DR. STALLWORTH: The email would

15 be from whom? 16 DR. HUBBELL: It'd be from Travis, 17 I believe. 18 DR. SMITH: I had emailed you 19 initially with the slides, and then I emailed 20 you later with the PDF. 21 DR. STALLWORTH: When did the PDF 22 come? Was that yesterday?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 213 1 DR. SMITH: Wednesday. 2 DR. STALLWORTH: They're posted

3 but --

4 DR. HUBBELL: We could download 5 them, and put them on the USB. Maybe we need 6 to delay and eat, and then come back, since 7 there's a technical glitch. 8 DR. FREY: Holly, should we wait 9 for this, or take our break now?

10 DR. STALLWORTH: I don't know. 11 DR. FREY: Yes, we don't actually 12 have any further public comments. That's a 13 good suggestion. Well, since we're waiting, 14 why don't we go ahead and take our lunch break 15 now. But let's try to keep it to 45 minutes,

16 and we'll start at 12:45. 17 (Whereupon, the foregoing matter 18 when off the record at 12:02 p.m., and resumed 19 at 12:47 p.m.)

20

21

22

### 202-234-4433 Neal R. Gross & Co., Inc. Page 214 1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 12:47 p.m. 3 DR. FREY: All right, so, Dr. 4 Travis Smith will be presenting on the welfare 5 scope and methods plan. Dr. Smith, the floor 6 is yours. 7 DR. SMITH: Gee, thank you. I'm 8 competing with the trickle in from lunch here. 9 So, this'll be pretty brief, I think, which -- 10 and we can move onto the comments, and people 11 will be ready to get out of here at the end of 12 a Friday afternoon. 13 So, this is just going over the 14 scope and methods for the welfare assessment 15 plan. And it's kind of in the same vein of 16 this morning, it's just trying to get input 17 and comment on the methodology that we've kind 18 of laid out, and the framework we've laid out 19 of how we want to go about this. 20 This is a very quick background 21 for the secondary standard that as of the 22 review completed in 2008, and prior to that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 215 1 the secondary standard for the ozone NAAQS set 2 is identical to the primary standard. 3 But as part of the current 4 reconsideration, the EPA has proposed a 5 separate secondary standard, using the W126 6 metric, and I'm not sure what the exact -- the 7 current -- July I think is the -- 8 DR. HUBBELL: Well, we don't know. 9 DR. SMITH: We don't know. So, 10 that's -- so, to kind of lay out what the kind 11 of framework we're using is, and this is kind 12 of built off of what was done in the NOx SOx 13 secondary analysis that was just -- or is also 14 still in the process of being completed at 15 some point. 16 I want to lay this out as kind of 17 an idea how we're trying to think about doing 18 this, and one is that obviously there's the 19 ambient ozone exposure, which leads to some 20 ecological effects, and then there's a series 21 of four different types of kind of following 22 the SAB report, and the millennium report.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 216 1 We're looking at four different types of 2 ecosystem services that there's kind of the 3 direct regulating, cultural and provisioning 4 services that are directly affected by some of 5 the ecological effects, and then there's 6 supporting services that are affected by the 7 ecological effects. 8 So, it's kind of an intermediate 9 affect, or an indirect affect. And part of 10 the reason for wanting to lay it out in this 11 structure, and also I should say this is not 12 intended to be a complete list of everything 13 we're going to look at. This is just to kind 14 of give an idea of how the framework is going

15 to work. 16 Part of the idea of laying it out 17 in this structure is that there are some 18 ecological effects that are very clear, things 19 like the biomass loss or the visible foliar 20 injury. There's a very clear affect of 21 ambient ozone on that end of that ecological

22 affect.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 217 1 In some cases, there's a very good 2 tie; how we can connect that to an ecosystem 3 service. In other cases it's not so clear. 4 And then there's other ecological effects. We 5 don't have -- from the ISA, there's either 6 conflicting data, or there's a number of data 7 and it was not fully linked together, and the 8 studies weren't -- we don't have good 9 ecological data on everything, but there are

10 others we can look at. 11 Part of the reasoning for laying 12 it out in this kind of structure is to allow 13 us to lay out what we do know. We do know 14 that there's a biomass loss, or we -- I think 15 -- system model conductance that we can talk 16 about, but we're not clear how it's going to 17 connect to an ecosystem service, and this way 18 we can lay out what we do know, and then lay 19 out as qualitatively as we can the parts that 20 we don't know, partly so they're out there for 21 the scientific community to see where are the 22 gaps in our knowledge so that we can use those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 218 1 in the future. 2 Because there are things we think 3 are important, but we can't -- we just don't 4 have the information to put them into a risk 5 assessment at this point, but we do want to 6 have them laid out so that they're available. 7 So, the first step of this, and 8 I'm not going to belabor the exposure surface 9 too much in the -- we've already had a lot of 10 discussion on exposure, but the big difference 11 for the welfare assessment is that we need to 12 interpolate an exposure surface to include 13 areas with few or no monitors. 14 So, a rural area where there's no 15 monitors there. And so, there is going to be 16 -- we do have to have a different exposure

17 surface that accounts for these areas that 18 just don't have very good monitor data. 19 So, the last risk assessment did 20 look at several methods. We've kind of 21 building off of that, and we're also looking 22 at two different methods, the model detainment

### 202-234-4433 Neal R. Gross & Co., Inc. Page 219 1 test software, that uses the 2005 -- the 2 current version that we have uses the 2005 3 CMAC, and ambient model data, which is the 12- 4 kilometer grids, and it couples -- and it 5 fuses that with the monitor data from 2004 to

6 2006. And we have then one surface based on

7 that set of data. 8 Another method we're thinking 9 about using is the Voronoi Neighbor Averaging 10 Interpolation, which the BenMAP actually has

11 a tool that allows to do that from BenMAP. 12 The difference of that would allow us to use 13 more recent monitor data, which would be from 14 2008 to 2010, which not to get back into the 15 discussion earlier, that was the big 16 discussion earlier as far as whether those are 17 the correct years. 18 So, whatever we do with those, 19 that will certainly be something we'll lay out 20 as to how we're going to assess which of those 21 works best, and try to decide how we're going 22 to use that. Which one works best to cover

### 202-234-4433 Neal R. Gross & Co., Inc. Page 220 1 both east to west? There are differences in

2 the eastern US and the western US. 3 So, some of the main ecological 4 effects that we really have very good 5 information from the ISA: one is the 6 concentration response functions for biomass

7 loss. Those come from -- there's 11 tree 8 species. They're basically the same as for 9 the last review, and really the difference 10 we're going to have is we're just going to 11 have a new exposure surface to compare that 12 with.

13 14 We do have a foliar injury in the 15 incidence data from the Forest Health 16 Monitoring Program, and the FIA data, and the 17 National Parks Service also has a list of 18 ozone sensitive species. Those are species 19 that are thought to exhibit foliar injury at 20 ambient levels. 21 Then we also have concentration 22 response functions for the domestic crops

### 202-234-4433 Neal R. Gross & Co., Inc. Page 221 1 species from data, which is the equivalent2 more or less of the biomass loss data for non3 agricultural species. 4 So, the first thing we're going to 5 try to do is look at a national scale 6 vegetation effect, which is more or less to 7 create a potential biomass loss surface for 8 those 11 species, using the new ozone exposure 9 data and the FIA species, the most up to date 10 FIA species range data, and it'll also have 11 the National Foliar Injury occurrence maps, 12 just as -- these are kind of a broad picture

13 look at the effects of ozone on these 14 vegetation. 15 Then there's also comparing those 16 to the endangered species critical habitats, 17 which are a -- those are obviously a 18 nationwide system of areas. 19 And so, you kind of skip to 20 ecosystem services now, and we're really kind 21 of looking at several models, and this is 22 actually trying to put valuation on some of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 222 1 the ecosystem services, as opposed to just 2 what the service is. 3 And so, where we have recreational 4 services, or recreational use, and we have 5 timber loss, crop loss, some of those are easy

6 to value. Some are not. These are some of 7 the models that we're looking at for using to 8 put valuation on things. One is the AGSIM 9 which puts using the data. There's the FASOM 10 model, which also gets into timber species. 11 Both of these are going to be 12 somewhat dependent on AGSIM. We can 13 potentially run in house. FASOM is an 14 external proprietary model that we're -- that 15 will not be run through the EPA. 16 Then we've also been talking with 17 the forest service on the use of the I-Tree 18 model, which looks at urban ecosystems, and 19 specifically models VOC emissions, building 20 energy use, pollution removal and carbon 21 storage, and sequestration within urban 22 forestry settings.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 223 1 So, kind of a new thing that we're 2 doing in this risk assessment from the last 3 risk assessment. We've included the idea of 4 trying to look at some case study areas, and 5 what we're hoping is that we can then do some 6 more refined analysis using the FIA species 7 range data. 8 Species don't have the same 9 abundance throughout their range. They don't 10 have -- there's a lot of different things. 11 They don't occur at every point within their 12 range. So, we wanted to try to go into some 13 areas where we could really get a much more 14 refined analysis to try to assess on a more 15 controlled scale what is the real -- the real 16 potential biomass loss, or the percent of the 17 area that might be affected by foliar injury 18 within these areas where we have better data? 19 And so, some of the selection 20 criteria, we came up with that as these 21 current areas -- we needed areas obviously 22 with kind of expected elevated ozone levels,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 224 1 and we also needed availability of vegetation 2 mapping, including estimates of species cover, 3 which is not -- there's a lot of vegetation 4 maps that cover them nationally, but they 5 don't really get into species cover in a way 6 that we could apply at this level. 7 We wanted to come up with adequate 8 geographic coverage to include -- including 9 urban and natural settings, but trying to get 10 a nationwide look because the ecosystems are 11 highly variable across the country, and that's 12 just how they are.

13 We also needed there to be current 14 -- we wanted there to be ozone sensitive 15 species there, or otherwise they would be kind

16 of a -- we wouldn't have much to talk about. 17 Then we do primarily have the 11 species where 18 we have the concentration response functions 19 for biomass loss. 20 So, the first set of places we 21 were looking at is the national parks. 22 There's this ongoing project with USGS to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 225 1 produce vegetation mapping. They include data 2 points with estimated species cover in those 3 areas, and they are pretty detailed maps, a 4 strength. 5 Not all the parks are done at this 6 point, but a number of parks are done, and the 7 mapping is, if not by all the same people, at 8 least using a similar method. So, they should 9 be as comparable as you can get across park 10 units. 11 There is the list of ozone 12 sensitive species for parks, and then we also 13 have GIS information for trails and other 14 recreation areas that we can look at how that 15 might be affected by biomass loss or foliar 16 injury and other things. 17 Then we also have the national 18 parks. We do have park use data. There are 19 a few parks that have willingness to pay 20 studies in relation to the ecosystem services. 21 So, the parks are a very good 22 source of information to try to get at some of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 226 1 the non-provisioning service ecosystem 2 services, primarily what are considered the 3 cultural ecosystem services of recreational

4 use. 5 So, the potential parks we've 6 thought of: the Great Smoky Mountains National 7 Park, Rocky Mountain National Park, and then 8 the Kings and Sequoia National Parks in 9 California. Some things we can look at are 10 certainly the percent of vegetation cover 11 affected by foliar injury. That's just taking 12 the combination of the estimated percent 13 species coverage areas within the park, and 14 applying that to the polygons of -- in GIS, 15 applying that to the polygons and really kind 16 of getting just a rough estimate. 17 It's not that this is not data 18 that's going to be highly variable. There's 19 going to be a lot of uncertainty in it, but it 20 is an estimate we can come up with. And then 21 we can also look at very species specific 22 biomass loss, where we have estimates of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 227 1 actual area cover per species that we do have 2 a concentration response function per proposed 3 biomass loss. 4 We can then really look at how 5 much actual biomass loss might we expect for 6 that species within the park. And then we can 7 look at the recreational areas, and make 8 estimates of how much -- what percentage of 9 the recreation areas within the park might be 10 expected to be affected by visible foliar 11 injury, or biomass loss or habitat loss. 12 This is something that we're 13 trying to go in the area of. This is going to 14 be very hard to quantify specific to an 15 ecosystem service, but given willingness to 16 pay studies when available, we might be able 17 to make some estimates of an expected affect 18 on the recreational value to the people using 19 the parks. 20 Within urban areas, a couple of 21 areas we've looked at is San Diego County in 22 particular. Before coming to the EPA, I lived

### 202-234-4433 Neal R. Gross & Co., Inc. Page 228 1 in San Diego. So, I'm familiar with this. 2 There's a multi-species conservation plan that 3 has very good vegetation mapping. So, we 4 might have an availability. 5 Boulder, Colorado has a regional 6 planning -- regional planning -- regional 7 plan. I'll get that out. And that does have 8 good vegetation area as well, and those are 9 some areas that we do know are ozone -- they 10 also share some ozone sensitive species with 11 nearby parks. And so, we do have information

12 about those areas. 13 As far as ecosystem services, we 14 can look at similar things to the national 15 park areas, where we also might be able to 16 include more specific information to some of 17 the wetland data, where we do have -- we do 18 know in places like San Diego how much money 19 gets spent by the county on dealing with 20 sediment runoff and other things that are part 21 -- that would be a wetland functioning. 22 Then we also might apply the I-

### 202-234-4433 Neal R. Gross & Co., Inc. Page 229 1 Tree model, which the I-Tree model may or may 2 not overlap with the specific case study areas 3 that have been used in Chicago and several 4 other areas. That would be another way to 5 look at the urban ecosystem services. And 6 that is it. 7 DR. FREY: Excellent. Thank you. 8 Are there any clarifying questions from the

9 Panel? 10 DR. GRANTZ: In the plan, there 11 was a lot of angst over whether to use AGSIM 12 or FASOM, which I commented on, and I couldn't 13 understand why it was there. Is that simply 14 a cost issue?

15 DR. HUBBELL: It's a cost and 16 access issue, as Travis said. We've been able 17 to bring AGSIM in house because we were able 18 to get the code from -- 19 DR. GRANTZ: because it was 20 inexplicable the way you -- 21 DR. HUBBELL: Right. Preferably, 22 we would use FASOM because it is an integrated

### 202-234-4433 Neal R. Gross & Co., Inc. Page 230 1 -- but Bruce McCall at Texas A&M is the only 2 one who can run it, and it costs money, and we 3 can't get it. 4 DR. GRANTZ: You ought to say that

5 then. 6 DR. FREY: Yes, Howard? 7 DR. NEUFELD: A couple things as I 8 was listening to this. Can you -- in terms of 9 trying to get the economic costs for natural 10 ecosystems, can you use some of these papers 11 that have been written by the ecological 12 economists, looking at the value of ecosystem 13 services? I mean I know one of them have been 14 ecosystem services three times the total world 15 GDP or something. I don't know if those are

16 useful or not. 17 DR. FREY: Well, there's two types 18 of -- there's the value of everything studies, 19 which is the Constanza study that you're 20 referring to. Then there's the value of 21 marginal changes, which are the ones you can

22 use.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 231 1 So, what we're looking for is 2 actually studies that allow us to look at the 3 willingness to pay for marginal or incremental 4 changes in ecosystem services associated with 5 an ozone exposure. Those are much more 6 difficult to get. And so, we're still looking 7 at trying to get those, but there are some 8 studies, and that's what Travis was referring 9 to is there are some studies that, for 10 example, look at recreational values due to 11 foliar damage. 12 There's also studies that look at 13 particular types of changes in other services 14 that -- for example, habitat and things like 15 that. So, there are some out there, but 16 getting those incremental changes is a lot

17 harder. 18 DR. NEUFELD: The other thing was 19 you were talking about percent cover of 20 species affected by ozone, and trying to 21 figure out how to do that, whether you had 22 vegetation maps and so on.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 232 1 Can you -- if you are lacking 2 those things, can you combine different data 3 sets? For example, there are tons of 4 ecological data sets of lists of species and 5 the frequency of those species, and there are 6 allometric equations then relating leaf area 7 and so on. So that if you didn't have a 8 vegetation map, but you knew what kind of 9 forests were in the general area, could you 10 sort of make best guesses by saying, "Okay, 11 it's probably following this distribution?" 12 DR. SMITH: I think we probably 13 could. I say that without looking -- but I 14 think at this point, in what we're trying to 15 do, we're kind of looking for what's the best 16 available information out there. Something 17 like that might work in areas where we don't 18 otherwise have good vegetation mapping. And 19 so, it might be very possible to include that. 20 It might be worth looking at those 21 in the context of the places that we do know 22 something about and see how well they match.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 233 1 DR. NEUFELD: Yes, right.

2 DR. SMITH: And then we could 3 potentially expand to other areas that we 4 thought were important. 5 DR. NEUFELD: Okay. And I think 6 too when you look at cover affected by ozone, 7 other than just looking at the polygons, I 8 mean Art Chappelka's data is -- and John 9 Skelly's and other people's data, show a very 10 clear impact of elevation. And the frequency 11 of the trees and the percent of the canopy 12 that's affected by ozone dramatically changes 13 with elevation, sometimes non-intuitively, 14 because of changes also with moisture as you 15 go up and down. 16 So, I think you need to take 17 elevation into account. The other thing would 18 be that in forested areas, you -- I don't know 19 how you're going to account for it, but ozone 20 is dramatically reduced as you go through the 21 canopy. 22 We did some brief studies, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 234 1 found that by the time you go to the height of 2 the herb layer, about a meter off the ground, 3 it was 50 percent of what was above the 4 canopy. So, it was reduced by half. And that 5 also was affected by elevation. 6 On a ridge top, it was only 7 reduced by a maximum of 20 percent. So, you 8 had these confounding variables or extra 9 variables that you need to -- otherwise, you 10 overestimate the ozone impact on everything in 11 the under story. 12 DR. HUBBELL: All right. 13 DR. NEUFELD: Then the last thing, 14 on the I-Tree model. Is this the same model 15 that comes out of the Southern Experiment 16 Station? Because the Auburn campus, for 17 example, was -- just designated a tree campus. 18 And so, they also had out of the Southern 19 Experiment Station a model assessing the 20 economic impact of the trees on the campus, 21 according to their size and state of health, 22 and vigor and all that kind of stuff. I'm not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 235 1 sure if that's the same thing or something 2 different, but that might be a model -- 3 DR. HUBBELL: Something we should 4 look at, yes. 5 DR. NEUFELD: Then they end up 6 giving an economic impact of the trees on that 7 campus. 8 DR. HUBBELL: Do you know who the 9 principal on that one was? 10 DR. NEUFELD: Well, the person you 11 could contact to find out more about it would 12 be Art Chappelka. 13 DR. HUBBELL: Okay. 14 DR. FREY: Okay, thank you. Let 15 me just check and see how is on the phone. 16 Kathy, are you on the phone? 17 DR. WEATHERS: Yes, I am, and I 18 have a question. 19 DR. FREY: Okay, let me just check 20 is Sverre on the phone? And John Samet? 21 Okay, so, Kathy, you had a clarifying 22 question?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 236 1 DR. WEATHERS: Yes, on the VNA 2 interpolation, what's the spatial resolution

3 for that? 4 DR. HUBBELL: The spatial 5 resolution is determined by the user. You can 6 limit it to a certain distance around the 7 monitors, or you can do unlimited averaging as

8 well. 9 One of the things that Travis was 10 talking about was -- was trying to do these 11 kinds of integrated assessments using the 12 model data, coupled with the monitor data, and 13 BenMAP can do that as well. It's a process 14 called Enhanced Voronoi Neighbor Averaging, 15 which basically means you're combining the 16 model gradient with the monitor data to be 17 able to interpolate those ratios. 18 We've always been a little 19 cautious about doing just straight VNA in 20 rural areas. What we have found in the last - 21 - the last time that this was used for the REA 22 was that it worked fine in the eastern US,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 237 1 even for relatively rural areas, because you 2 had such a dense monitoring network. But in 3 the western areas, it doesn't perform quite as

4 well. 5 So, there was -- that's what the 6 question about what's the best way to get a 7 good surface that covers both the east and the 8 west; that's still something we're evaluating. 9 DR. FREY: Okay, Kathy, is that 10 it?

11 DR. WEATHERS: Yes. 12 DR. FREY: Okay, thanks. Joe? 13 DR. BRAIN: Could you educate us a 14 little bit more about the options and where 15 this is going? You know, gets back to the 16 possibility that this would be a separate 17 secondary standard in the W126 metric. Is it 18 possible that this standard would be more 19 stringent than the primary standard, or what? 20 How do you see the options moving forward? It 21 sounds like you know a lot of interesting 22 data, but where do you see the range of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 238 1 options being? 2 DR. HUBBELL: I think it's quite 3 early to think about the range of options, but 4 in terms of the proposed standard for the -- 5 for the current proposal, I don't have the 6 maps that would show which one is more 7 stringent or less stringent. But obviously, 8 if you are measuring in rural areas, such 9 areas that we're not traditionally covering 10 with, our urban monitoring network. So, it 11 does kind of change the complexion of where 12 you'd be concerned about affects, and what 13 you'd be looking for compliance with. 14 But the range of the proposed 15 standard was seven to 15 ppm hours I think was 16 what the proposal was, and it was on one of 17 our earlier slides. It was the one that was 18 in the introduction to the ISA yesterday had 19 the range that was proposed. 20 Again, it is a different form, so 21 it is not directly comparable in terms of 22 eight-hour versus, say, one hour. It's eight-

### 202-234-4433 Neal R. Gross & Co., Inc. Page 239 1 hour versus a cumulative weighted seasonal sum 2 of concentrations.

3 DR. BRAIN: And all the 4 consideration of the PDR looms as large or 5 larger here as well? 6 DR. HUBBELL: It does. In fact, 7 if you're thinking about monitoring or 8 attainment in places like national parks, 9 where background becomes much more of an 10 issue, then yes. It becomes potentially a 11 larger issue relative to the urban peak areas, 12 for example. 13 So, yes, those are -- those are 14 all the same exact questions that exist. 15 DR. FREY: Okay, let's see. I 16 know we had Howard and then Fred, and I can't 17 resist saying that the first draft policy 18 assessment is due out a year from now. So, 19 it's not that far before we'll be addressing 20 these questions. 21 DR. HUBBELL: Yes, but let's wait

22 for that to occur.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 240 1 DR. FREY: So, I guess Howard was 2 first. 3 DR. NEUFELD: With response to the 4 previous couple slides earlier, where you were 5 talking about the 11 tree species and their 6 response functions, are you looking into the 7 hourly ozone distribution of those exposures? 8 Because back then, when a lot of those were 9 done, I know when I did mine, which I'm still 10 trying to get published, we did percents of 11 ambient, because that's what we were told to

12 do. 13 And then someone had the brighter 14 idea that you shouldn't just do percents of 15 ambient. You should cap it so that you don't 16 have unrealistically high concentrations if 17 the ambient goes up to 100, and you're zapping 18 with 200 or 300. 19 So, I'm wondering if you looked at 20 that, and decided did they cap their maximum 21 concentrations since you don't compare a study 22 that capped it with one that didn't cap it?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 241 1 Like I think if I get mine 2 published, which I hope to do, we -- you know, 3 it was so long ago that we didn't cap them. 4 So, you may have a caveat there about that the 5 highest ozone concentrations of those response 6 functions. 7 DR. SMITH: I'll check with them 8 as far as doing that. We're working with them 9 on exactly what was in those studies, and 10 there are additional species that ORD looked 11 at that the data -- there were some studies 12 that were excluded because they didn't -- the 13 methodology wasn't comparable. 14 And so, there are -- in addition 15 to those 11 species, there are other species 16 that there were studies for, but the study 17 wasn't comparable, and that's something that 18 we -- I'll work with them, and we'll be trying 19 to decide exactly what those studies say to 20 make sure we are using comparable information. 21 DR. NEUFELD: I mean it's hard 22 when you're in a teaching institution, but if

### 202-234-4433 Neal R. Gross & Co., Inc. Page 242 1 we can get this published, we can probably 2 double the size of your sample method. 3 DR. HUBBELL: That'd be great. 4 How many more drafts? Two more drafts and --

5 DR. NEUFELD: I need a 6 statistician is what I need. 7 DR. HUBBELL: Okay.

8 DR. FREY: Fred? 9 DR. MILLER: Following up on Dr. 10 Brain's clarification, question on the PRBs. 11 Does the amount of modeling support for the 12 health in that are coincide for what's needed 13 for the welfare? Or, do you have to go down 14 separate avenues in the way that you're doing

15 that? 16 DR. HUBBELL: Well, we'll be 17 having to calculate the different index value, 18 but the hope is to use the same GEOS-Chem 19 modeling, which just means an additional 20 calculating eight-hour averages and things 21 like that that match with the health indexes. 22 We're going to have to be calculating these

### 202-234-4433 Neal R. Gross & Co., Inc. Page 243 1 cumulated index values, but it will still be 2 based on the hourly data, yes. 3 DR. FREY: Yes, David? 4 DR. CHOCK: One quick question. 5 Are you going to incorporate the water stress, 6 temperature stress, on the ozone effect? 7 DR. SMITH: I don't -- it'd be 8 great if we could. I don't know. I can't 9 answer positively yes or no on that at this 10 point. It certainly does -- unfortunately 11 dealing with ecosystem of any form that 12 there's so many variables. To account for 13 every variable would be great. In reality, 14 that's going to be somewhat less than easy. 15 DR. HUBBELL: But in all cases, if 16 we've identified one of those issues, we'll 17 certainly treat it qualitatively at the very 18 least, but we are limited by some of the data 19 that's available. 20 DR. FREY: Any other clarifying 21 questions? Seeing none, let's move onto the 22 input from the discussants on -- we had two

### 202-234-4433 Neal R. Gross & Co., Inc. Page 244 1 groups of topics. One is air quality 2 considerations. The other is eco-effects and 3 ecosystem services. In the air quality group, 4 we have Daniel, Jacob, George Allen, Ted 5 Russell and David Chock. And I know that 6 Daniel is going to be leaving us in a little 7 bit, but do we have enough time that -- please 8 give us your wisdom? 9 DR. JACOB: Well, I already talked 10 this morning on the PRB issue. One question 11 I had was the Europeans are using AOT40 12 metric, that's in vegetation. Is -- it would 13 actually I think make your results more 14 sensitive to the background, right? 15 Okay, all right. I guess bottom 16 line question is to what extent is your choice 17 of metrics for the effect of ozone on 18 vegetation affect the sensitivity to 19 background ozone?

20 DR. HUBBELL: I don't -- we have 21 not investigated that, and I don't know 22 whether -- has ISA looked at that at all,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 245 1 Jeff? Come on up here. 2 DR. HERRICK: This is Jeff Herrick 3 from NCEA. I think you're asking what kind of 4 metrics we are -- they might be using to look 5 at, and as for background, AOT40 wouldn't -- 6 obviously wouldn't consider any hourly 7 concentrations below 40. 8 So, I would think there would be 9 less of a background, but then there's a few 10 peaks in the spring that could -- that could 11 accumulate with that. And with the W126, it's 12 a smooth similarly weighted function. So, 13 there actually would be a little more 14 weighting from that. 15 The data I've seen is the 16 background -- I mean if you look at Al 17 Lefohn's comments, it -- it's still quite 18 small. Still quite small, in fact, because it 19 weights those concentrations very low. 20 So, everything below 60 with the 21 W126 is weighted fairly low. 22 DR. JACOB: Well, that's my whole

### 202-234-4433 Neal R. Gross & Co., Inc. Page 246 1 point. So, W1s6 wouldn't be too sensitive of 2 a background, but Aot40, which I understand 3 counts linearly any enhancement -- 4 DR. HERRICK: Yes, anything above

5 40. 6 DR. JACOB: Yes, well, that would 7 have a huge background sensitivity. Because 8 40 is about the level of a background that

9 would elevate the --

10 DR. HERRICK: And that's one of 11 the reasons that in the last review we decided 12 to use the W126, because it makes more sense, 13 I think intuitively and scientifically, to -- 14 that you shouldn't weight the same something 15 like a 45 parts per billion as much as you 16 weight 100 parts per billion. 17 So -- but they're very, very well 18 correlated. So, we looked at all the monitors 19 for the whole country, and we looked at W126 20 and AOT40, and it's pretty much a linear 21 relationship between them. So, they're very 22 similar. But if there's weird things

### 202-234-4433 Neal R. Gross & Co., Inc. Page 247 1 happening at a certain site, they might 2 deviate. 3 And I think the W126 just does a 4 better job of characterizing the exposure, in 5 my personal opinion. So, I think -- and also, 6 we probably won't be looking at AOT40, because 7 we don't have any concentration response 8 functions for our studies that use AOT40. We 9 have AOT60. We're sort of bound by the work 10 that's already been done in the late '90s with 11 the tree species. 12 So, all we -- the only metrics 13 that we have to work with are W126, SUM06 and 14 AOT60, and some -- and some other things. 15 DR. JACOB: So, what are Europeans 16 basing their AOT40 -- 17 DR. HERRICK: They're basing it on 18 European tree species. So, they have European 19 Beech, Norway spruce, things that don't 20 generally grow naturally in the US. And they 21 also have a lot of crop data with AOT40, but 22 it's very similar to W126. You could -- we've

### 202-234-4433 Neal R. Gross & Co., Inc. Page 248 1 looked into making a transition between the 2 two metrics. 3 DR. JACOB: But I suspect it might 4 be different in terms of sensitivity to the 5 background. 6 DR. HERRICK: I think that might 7 be true, and I think using W126 would be a 8 better way of looking at the background.

9 DR. NEUFELD: There's also a 10 slight distinction -- if I have this right, 11 the official European usage of AOT40 is only 12 if the radiation level is above a certain 13 point. 14 Essentially, they're assuming that 15 there's only in effect if the plants have 16 their stomata open. But if plants open their 17 stomata at night, then AOT40 would miss that. 18 DR. FREY: Okay, thank you. 19 George, the floor is yours. 20 MR. ALLEN: Thanks, Chris. I 21 guess start with the broad comments first. 22 Daniel and I have had some discussions, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 249 1 this actually goes back to the ISA as well. 2 So, it really covers both processes. So, 3 primary and secondary. 4 As noted before, the last two 5 years '09 and '10, were unusually low years. 6 And then it occurred to Daniel and I, well, 7 you know GEOS-Chem for this round is going to 8 be '06 through '08, and if you look at at 9 least the northeast, and I think this issue is 10 for most of the eastern US, '06 through '08 11 were relatively normal years 12 when you take them as a whole. '07 was higher 13 than usual. '08 was lower than usual, and '06

14 was usual. 15 So, there's two things going on 16 here. One, I would be -- it would be nice to 17 sink the GEOS-Chem output with the 18 observational data in a temporal sense. And 19 again, you really don't want to be picking a 20 three-year period where you are clearly going 21 to be underestimating what the normal exposure 22 would've been, be it plants or people.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 250 1 So, I would strongly encourage 2 both the primary and secondary process to use 3 '06 to '08. Yes, it's not the most recently 4 available data, but it's probably the most 5 relevant in terms of what's going on at this 6 point in time. 7 If you look at the overall trend 8 plots, those years fit in very nicely. And 9 ozone levels have stopped dropping rapidly in 10 most areas. We picked the low-hanging fruit, 11 and I think some of the trends have just about 12 flattened out. Washington Summit is flat for 13 those ten years. That tells a big story in 14 terms of regional ozone. 15 If I were a regulator, I'd be a 16 little concerned, seeing such a flat lack of 17 trend, but actually that's the state's 18 problem. They have to do the SIPs. So, if I 19 were a state SIP person, I'd be worried. 20 A more general comment, which 21 might be a little heretical, and please feel 22 free to interrupt me if I go off the deep end

### 202-234-4433 Neal R. Gross & Co., Inc. Page 251 1 here, but I know this process is resource 2 constrained, both primary and secondary. My 3 view of it is that -- two things. 4 The primary is probably more 5 important in terms of protecting public 6 health. Not that welfare is not important. 7 It is. But if you had to -- if you have 8 resource constraints, then I would encourage, 9 and especially EPA is talking about going from 10 12 to three or four cities to do the urban 11 analysis on. 12 I would encourage resources to be 13 not completely pushed over to the primary, but 14 properly apportioned in a rational manner. 15 And there's another argument for that. I mean 16 in theory, a type -- a decent protective 17 primary will also have benefits for the 18 welfare standard as well, without any doubt.

19 You reduce the sources. You're 20 reducing the regional, which means you're 21 reducing the rural. So, that's just a 22 thought, a concept. To the extent that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 252 1 resources are constrained, it might be worth 2 thinking about. 3 Getting back to the -- okay, in 4 the 2010 NPRM, we had upper range of 70 for 5 primary, and a very wide range of seven to 15 6 for the W126. Now, the question is, "Okay, 7 what's controlling?" 8 Well, if you go with 70 for the 9 primary, you have to go much closer to the low 10 end of the secondary, meaning seven. At 15, 11 it does nothing. It's there on paper, but it 12 doesn't change anything. You don't change 13 much of anything in terms of actual welfare 14 exposures until you approach the low end of 15 that range. 16 There's another rationale for 17 maybe moving resources around it, unless 18 there's strong evidence that you would go for 19 a controlling secondary. 20 All right, that's the big picture 21 stuff. Minor comments on chapter 2. It makes 22 note of class 1 air sheds. In the past, I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 253 1 don't think that's been notable, other than 2 for regional haze where they've been a big 3 player, but I guess the question is will more 4 emphasis and attention be paid to protecting 5 the class 1 air shed areas? That's one 6 question. 7 The next paragraph talks about 8 portable monitors, and I'm hoping that they're 9 referring to the things with FEM stickers, 10 like the 2B technologies, which is out in 11 actually a very nice package. And so, we have

12 robust data. 13 Remote sensing, I don't know how 14 useful remote sensing data is for ozone. If 15 you're doing total column ozone, you have -- 16 the stratosphere kind of messes that up. So, 17 I'm not sure how much value that'll be, but 18 I'm not really an expert in that. 19 And then there's a piece on the 20 section to that one, looking at gradients and 21 elevation. There is some work that may not 22 have been published that I did with the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 254 1 Appalachian Mountain Club on Mount Washington 2 back in the late '80s, that actually formed 3 the basis for the Korek et al 1993 paper that 4 figures into the primary standard. 5 But we did measurements of the 6 summit, and at the base of Mount Washington, 7 and have a lot of good vertical gradient data, 8 summertime only. But those data do exist, and 9 could be made available if that helps. I 10 believe that's it. Thanks. 11 DR. FREY: Okay. Any follow-up to 12 George's comments? 13 DR. HUBBELL: Let me just mention 14 about the resource issue. While I appreciate 15 the sentiment, and it would be nice if we 16 could do that, unfortunately we have a 17 resource constrain; not only a dollar 18 constrain, but people. People are not 100 19 percent fungible between ecological and 20 health. And so, you can't just switch those 21 back unfortunately. 22 So, our welfare folks will

### 202-234-4433 Neal R. Gross & Co., Inc. Page 255 1 continue to focus on the ecological things 2 that they're experts in, and we have to kind 3 of work within those constraints. But it'd be 4 nice if we had that ability.

5 DR. HERRICK: As far as the 6 portable ozone monitors, those refer to 2B 7 technology monitors. 8 DR. HUBBELL: That's great. Good. 9 DR. FREY: Fred? Oh, I'm sorry. 10 DR. JACOB: Could you respond to 11 the comment about using 2006 versus 2008 -- 12 DR. HUBBELL: Yes. You know, it's 13 an interesting point to be made about trends 14 versus deviations from trends, and that's what 15 -- the one thing that I was a little concerned 16 about when I saw your original comment with 17 the plot is that there's clearly been a 18 downward trend, and I don't know that anybody 19 is -- you know, looked to see whether that -- 20 that consistency of the flattening and whether

21 or not we should assume that we're on a new 22 trend that's -- or a different part of a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 256 1 curve. 2 But it makes me a little bit 3 nervous to simply say, "We'll only use 2006 to 4 2008." I think using a longer period maybe 5 makes some sense, or thinking about it, or 6 trying to detrend the data so we can get an 7 idea of what actually would be the -- the new 8 balance equilibrium conditions that we would 9 be returning to. 10 There is some of that lowering 11 that may be permanent. You know, shut downs 12 or other things may be permanent. We don't 13 know for sure. But I'm just a little cautious 14 about saying, "Well, it was a good year in 15 terms of low ozone, and we have to assume 16 that it's going to go back to the old." 17 So, I think we need to do some 18 evaluation to determine how to -- you know, 19 obviously a met adjusting can help with some 20 of this, but at the met adjusted data, but 21 whether or not we can adjust for economic 22 trends that are either permanent or not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 257 1 permanent, I don't know. But certainly 2 looking at a broader average would make some 3 sense, perhaps without maybe just saying, 4 "Well, I'm only going to look at this 2006 to 5 2008 period." 6 DR. JACOB: What about this 7 concern that was expressed this morning about 8 making sure that the background estimates and

9 -- 10 DR. HUBBELL: Well, that's clearly

11 the reason to use 2006 to 2008. And the 12 question is can we do some type of an 13 adjustment, and then maintain that adjustment 14 in looking at the additional years? I don't 15 have an answer for that, but I definitely 16 think it's important to try to at least match

17 the data that we do have. But how we extend 18 that to additional years, I need -- we need to 19 think about it. 20 MR. ALLEN: And I would strongly 21 encourage that that linkage be kept in mind, 22 because I think it's very important. And in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 258 1 terms of '09, I mean if you look at the Summit 2 Mount Washington smooth data in my primary ISA 3 comments, '09 is no different than the 4 previous four years. 5 So, at that level, both vertically 6 and spatially regional, it was a normal year. 7 But at the ground, it wasn't. So, in terms of 8 source and major trends, if you look -- and if 9 you look at a few other sites like that, you 10 may find that there really isn't a lot of 11 trending when you go back to that larger 12 scale, which would support using '06 to '08. 13 I understand the concerns, and -- 14 but I am also very -- I can't emphasize too 15 much the trying to link it with GEOS-Chem date 16 period. I think that's extremely important.

17 DR. FREY: It was Fred and then

18 Howard.

19 DR. NEUFELD: If I could make a 20 real quick comment?

21 DR. FREY: Go ahead. 22 DR. NEUFELD: -- 20 year trend,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 259 1 and covered many of the same national parks 2 and so on, and just chock full of data. 3 DR. MILLER: I wanted to go to 4 what George was talking about on relative 5 prioritization. I understand people are 6 interchangeable, and I agree. 7 But if they were dollars that had 8 to go outside of EPA, I would actually put a 9 higher priority on the welfare than I would 10 the health, and the reason I say that is it's 11 extremely unlikely that anything that's done 12 for the health is going to change the range 13 compared to what happened for the last round 14 of the 60 to 70, and you have those analyses 15 in place. 16 And so, you're going to be doing 17 some sensitivity, and updating that but 18 getting this welfare, the CT thing down, and 19 making it locked, and realizing you need a 20 different primary compared to secondary, if 21 you had to, getting that in place is going to 22 be more important for the welfare at this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 260 1 point. 2 So, I actually say that the health 3 is very important, but it's probably the 4 things you're going to do aren't going to 5 change the story compared to the previous 6 revision, whereas it could have a big impact 7 relative to the welfare. 8 DR. HUBBELL: And some of this 9 depends on the results of the new 10 reconsideration package. And if we get a 11 secondary standard, then -- 12 DR. MILLER: Well, my crystal ball 13 says -- in fact, I'll be willing to put out 14 all the money in my wallet on the table, and 15 tell you that it will be implemented. It's 16 going to be 0.070, and it's going to be the 17 CT. Anybody want to bet against me. But we 18 don't have to wait long to find out. I never 19 keep more than $1,000.00. No, I think there's 20 maybe $60 in here. 21 DR. FREY: Okay. Ted, you're up

22 next.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 261 1 DR. RUSSELL: First, the comments 2 from this morning still hold in terms of how 3 you use GEOS-Chem in determining the PRB. I 4 think that however you choose to debias it, 5 you just have to really be careful in how you 6 justify it. 7 I'm a little bit -- that concern 8 gets a little bit heightened now that you're 9 talking about possibly using CMAC to help 10 develop the ozone surfaces. Not that that's 11 necessarily wrong, but that just adds a new 12 uncertainty. 13 So, I'm not saying don't do it; 14 just make sure you justify it, and provide 15 what sort of uncertainty that implies. And it 16 could be that between that and VNA, you're 17 talking about one or two ppb everywhere, which 18 would be a good estimate of what level of 19 uncertainty you're really talking about. 20 So, again, just specify that. Do 21 the analysis, and show that it's a reasonable 22 thing to do. And in the end, provide the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 262 1 uncertainties for the whole thing. 2 I'm not sure, but I think this is 3 something you need to do is really look at how 4 you adjust the values below the PRB again. I 5 mean if you're looking at the W126, probably 6 not a big thing. But you just want to make 7 sure that you've looked at that. 8 I think you need to get back to 9 NCEA. I'm sure you're getting back all the 10 time, and when I start reading the -- these 11 documents, there's some more work that needs 12 to be done in the ISA as to their -- the 13 support for your analysis, in particular what 14 sort of model evaluations need to be done in 15 terms of 126, how well it reproduces 126, 16 W126, and what the trends have been in the 17 W126 over the years, and how that might be -- 18 how that also will look in the future. 19 So, that again is another issue is 20 providing an analysis of what's going to 21 happen to the background at 126 in the future. 22 And with that, I think those -- oh, the other

### 202-234-4433 Neal R. Gross & Co., Inc. Page 263 1 thing is when you make a choice as to which 2 national parks you might use, some overlap 3 with what was done in the NOx SOx secondary 4 would be good, as much as possible. Just to 5 be really good for the next time around on the 6 NOx SOx as well, to really have certain areas 7 really well characterized and analyzed. 8 DR. FREY: Ted, you're not aiming 9 for a NOx SOx ozone secondary standard are 10 you? 11 DR. RUSSELL: No, no. Certainly 12 not after trying even two. 13 DR. HUBBELL: You thought that the 14 ANC based standard was complicated, right? 15 DR. FREY: Okay, thank you, Ted. 16 David Chock? 17 DR. CHOCK: I don't really have 18 any comments. 19 DR. FREY: Anyone on the phone 20 have comments on air quality considerations? 21 I guess "anyone" meaning Kathy. 22 DR. WEATHERS: Nothing additional.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 264 1 DR. FREY: Okay, anyone else in 2 the room have a comment? All right, well, if 3 not, then let's proceed to the ecological 4 effects. Oh, I'm sorry, Peter. 5 DR. WOODBURY: Yes, I didn't 6 really separate out my comments as to air 7 quality versus others, but I did have one that 8 -- there was discussion that consistency with 9 the health risk assessment is desirable, and 10 that's certainly true. But -- and I think it 11 has come up over the discussion today and 12 yesterday. There's a number of reasons why 13 exposure modeling should differ between these

14 two. 15 So, obviously with a different 16 method applies a different approach. And 17 again, we've already discussed places where 18 vegetation is occurring, a concern about some 19 rural areas with little monitoring. 20 I guess just a comment perhaps is: 21 we do have monitors in many rural areas, and 22 I think it's important not to overstate the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 265 1 uncertainty about ozone exposures in rural 2 areas. For many of these areas, especially 3 the low elevation ones, I think they can be 4 characterized fairly well. 5 I should say low elevation areas 6 in the eastern half of the country. 7 Obviously, there are challenges with the 8 mountainous areas, particularly in the West. 9 I'll stop there. 10 DR. FREY: Okay, thank you. So, 11 yes, we'll move onto ecological effects and 12 ecosystem services, and, I guess, Peter, 13 would you like to continue with your ecosystem

14 comments? 15 DR. WOODBURY: Sure. Again, I 16 think this has been covered already, and this 17 is still I guess on the exposure side, but the 18 whole issue of policy-relevant background, how 19 it's going to be estimated -- and again, these 20 points have come up through the discussion. 21 I'm not going to repeat them, but just please 22 go back to the discussion yesterday, anything

### 202-234-4433 Neal R. Gross & Co., Inc. Page 266 1 related to this issue, including the point2 about the challenges that models such as GEOS3 Chem currently have with estimating 4 preindustrial background. 5 So, again, that's an uncertainty 6 for policy-relevant background now, and 7 relevant to this topic as well. 8 I'm skipping through some things 9 that we've already discussed here, so bear 10 with me. It's a good cause. Just try not to 11 be too repetitive. 12 It's certainly useful to use the 13 FIA data, and just to comment on vegetation 14 cover or vegetation frequency and occurrence 15 data: there's a lot of data in FIA on that, 16 not just for tree species. So, pay attention 17 to that as a source of vegetation data. 18 And again, this came up yesterday, 19 but we should be thinking about impact on 20 sensitive species and sensitive populations 21 within species, and those -- the sensitive 22 populations just can't be mapped. Some of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 267 1 them may be gone. We may never be able to map

2 those. 3 So just some acknowledgment of 4 that issue. As far as choosing sites, you may 5 want to look at Acadia National Park. I don't 6 know how it stacks up in terms of exposure 7 levels, but there is a database of -- of both 8 surveys of natural vegetation in the park and 9 open-top chamber experiments located in the 10 park from a number of years ago that have been 11 published. So, there are site-specific data 12 there that might be useful. 13 For the figure on ecosystem 14 services, it's mentioned in there that a more 15 comprehensive list is needed, and I agree with 16 that. I think it's a great idea to try to be 17 more comprehensive in that list, even if 18 everything can't be addressed quantitatively. 19 So, in particular, pay attention to chapter 10 20 in the ISA. Some of those claimant related 21 issues. 22 I would encourage the staff to not

### 202-234-4433 Neal R. Gross & Co., Inc. Page 268 1 get overly focused on -- at the regional scale 2 for forests looking at biomass effects, and 3 similarly for urban areas. I'm not sure that 4 tree biomass increment is going to be the most 5 sensitive -- well, I don't think that that 6 will be the most sensitive nor the most 7 important ecological impact in urban areas or 8 in most forests, especially mixed species

9 forests. 10 So I think, again, this discussion 11 came up with the ISA, mixtures of sensitive 12 and insensitive species. We should be looking 13 for almost a more dramatic effect on the 14 ozone-sensitive species. Kind of an enhanced 15 negative competitive effect on them. We might 16 see no effect at all on total biomass 17 production in the forest. 18 To the extent that those sensitive 19 species have particular value, that could be 20 quite important. And again, this has come up 21 before, but we don't have data. We don't have 22 data on the ozone sensitivity of most plant

### 202-234-4433 Neal R. Gross & Co., Inc. Page 269 1 species. 2 I guess this is -- I'm going to be 3 a little bit long-winded on the next point 4 because I feel very strongly about it. For 5 economic impacts, some of the literature on 6 ozone -- on economic impacts of ozone on 7 vegetation has looked at kind of a national 8 effect. Say, what's the effect on a sensitive 9 species such as ozone? You know, what is the 10 effect on a total soybean production in the 11 country? What's the effect on the return to 12 farmers? Kind of these rather gross economic 13 impacts. 14 I am not in favor of giving those 15 very much weight. I think it's very important 16 to look at ozone impacts on a more local 17 scale. So, in an area with ozone, if Farmer 18 X in an area with higher ozone exposure has a 19 decreased yield, that is an economic impact on

20 that farmer. 21 And just because some other farmer 22 in a low ozone area in the US, or in another

### 202-234-4433 Neal R. Gross & Co., Inc. Page 270 1 country, these are global commodities, just 2 because they got a higher income because they 3 had less ozone and they got a higher relative 4 yield, I don't think those costs and benefits

5 should cancel each other out. 6 So, when you kind of look at the 7 larger national impacts, you're looking at a 8 net economic impact. And I think that's the 9 wrong way to look at it. I think it's an 10 important effect if you're shifting income

11 from some farmers to others because of ozone. 12 So, I think there are ways to 13 still quantify those impacts, but it needs to 14 be kind of disaggregated. Does that make

15 sense?

16 DR. HUBBELL: It makes sense. 17 There's some issues with that, but it makes

18 sense. 19 DR. WOODBURY: Well, I think in 20 fact it can be done in some fairly simple but 21 informative ways, without -- in addition to 22 the, say, more equilibrium market modeling

### 202-234-4433 Neal R. Gross & Co., Inc. Page 271 1 approaches. 2 And on a similar vein, maybe it 3 wouldn't cost us much to import more soybeans 4 from another country, but that also -- that's 5 an impact that should be looked at. It 6 shouldn't just be kind of swept into the grand 7 scheme of, "It only costs us 0.1 cents more

8 for each block of tofu." 9 I guess for the FASOM model, I 10 understand your motivation that you'd like to 11 model effects on forest economics, the 12 forestry sector. I would question whether the 13 FASOM model is really capable of modeling 14 ozone impacts on forest production. Is it 15 capturing the important processes, such as 16 competition between sensitive and less 17 sensitive species? I really doubt that it is. 18 DR. HUBBELL: It actually doesn't

19 at all. 20 DR. WOODBURY: If you would plug 21 in a very simplistic kind of growth decrement 22 into FASOM, and I guess I would question with

### 202-234-4433 Neal R. Gross & Co., Inc. Page 272 1 accrued parameterization of a model that may 2 not be representing the key processes, how 3 much information do you get out the other end? 4 I don't have an answer for that, but you can 5 hear that I have serious questions about how 6 much value you'll get. 7 DR. HUBBELL: Well, the only thing 8 on that is that we -- and this -- it's an 9 important question about how to deal with 10 forest yield changes, and we have -- in the 11 past we've really struggled with this in terms 12 of you have these individual biomass loss 13 functions, and then we've tried to follow 14 those through. 15 We played with using the ZELIG 16 model, which is stand-alone model, to try to 17 get those interactions. It was very difficult 18 to try to apply because there was so few 19 species that we actually had data on. 20 So there were some real questions 21 about how to play this out through this, and 22 some of the stuff that Travis mentioned about

### 202-234-4433 Neal R. Gross & Co., Inc. Page 273 1 doing more mapping of where the sensitive 2 species are and things like that, was an 3 attempt to give a flavor of the information 4 without trying to take it all away to model it 5 through the economic models. 6 I mean, ideally, if we were able 7 to have a broader set of species response 8 functions, we could get the ZELIG modeling and

9 the results of those models at the stand level 10 would be fed into FASOM, and it would be 11 output that way. But if they said we could 12 actually provide that, then FASOM is a very 13 good tool because it allows you to look at 14 competition between agricultural and forest 15 uses of land, and that's a benefit to do that. 16 It has been used. What it was 17 really developed for and used for has been 18 climate programs, looking at sequestration 19 things. So, it'd be great it we could do more 20 with it, and I think this is one of those 21 things where ideally we'd like to be able to 22 push forward on this. This is a gap, an area

### 202-234-4433 Neal R. Gross & Co., Inc. Page 274 1 that needs a lot more development. 2 We tried several years ago to 3 decide whether we could actually expand the 4 number of species that we cover by using some 5 homology mapping, using some various different 6 approaches to try to say, "Well, what's 7 driving that concentration response 8 relationship?" It didn't do very well. We 9 haven't been able to identify the factors that 10 determine ozone sensitivity based on the 11 available data because it's so sparse. 12 So, it's a real area that is very 13 limited, but yet is identified as one of, 14 potentially, the bigger impacts, and you've 15 seen some of the studies in China, where they 16 -- they really did try to do these types of 17 estimates of yield losses and its impacts on 18 timber production, but also carbon 19 sequestration. And they've been enormously 20 impacted by ozone, but we can't do something 21 similar here because we don't have the data, 22 which is unfortunate.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 275 1 DR. WOODBURY: Well, again, as 2 you're aware, the exposure response functions 3 for tree species are available for seedlings 4 only. That's another important limitation. 5 So you have a couple of scaling uncertainty 6 issues, and that's quite a large one, whether 7 mature trees in forests are more sensitive or 8 less sensitive than seedlings. We don't have 9 a clear picture of that. 10 I guess I would just encourage you 11 again to think about -- focus on some of the 12 species where there are adequate data to 13 suggest that there are stand-level impacts. 14 So, it may be on monocultures of sensitive 15 tree species. 16 Perhaps focusing on those might be 17 -- might give you a more robust result, 18 although obviously only for a subset. But I 19 guess I just agree with the issue you brought 20 up, that we don't have data to parameterize a 21 model like ZELIG. That doesn't mean that it's 22 going to be any easier to do in a more

### 202-234-4433 Neal R. Gross & Co., Inc. Page 276 1 simplistic model. That's not -- that's just 2 a non sequitur to me. 3 DR. HUBBELL: Your point is about 4 the total change in biomass versus its 5 apportioning between species. That's a really 6 important issue, and unfortunately not one 7 that we can do much about at this point. 8 DR. WOODBURY: Again, on the 9 forestry side, I would encourage you to look 10 at, if there's a likelihood of losses of -- of 11 forest increment production, that's an 12 important impact, whether or not there's an 13 impact at the national and global sawlog

14 market level. 15 DR. HUBBELL: One other response 16 to your question about apportioning to 17 individual farms versus the overall welfare 18 impacts. One caution -- the reason why I 19 exercise caution in that is there are two 20 things that go on. One is a yield effect and 21 the second is a price effect. What happens 22 when you have globally lower yields is that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 277 1 the prices go up. 2 And so, everybody benefits from 3 that, in terms of a price per unit. So, one 4 thing we've heard from farmers, not 5 necessarily that I agree that they're correct 6 in their interpretation is they don't 7 necessarily want their yields increased as a 8 global sense. They want their individual 9 yields increased so they can get more benefit, 10 and that's what the -- the relative yield is 11 important for who gets the benefit, but 12 everybody benefits from higher prices. 13 And so, there's -- you have to be 14 sure in terms of thinking about looking at 15 yield versus the value of that yield. In many 16 ways, I'd rather just look at the yields, and 17 say there's a yield impact, but once you get 18 into putting in into dollars, you really do 19 have to take into account the market 20 interactions. Otherwise, it gets a little 21 shaky in terms of interpretation. But yields 22 you certainly can look at how gets yield

### 202-234-4433 Neal R. Gross & Co., Inc. Page 278 1 increases and yield losses. 2 DR. FREY: Daniel had a -- 3 DR. JACOB: Is it just farmers'

4 dollars that matters? 5 DR. HUBBELL: Well, this is the 6 other half of it. And when you do the AGSIM 7 modeling for example, it calculates what is 8 called producer surplus and consumer surplus, 9 which is the excess amount of value that each 10 group gets. And what you're looking at really 11 is the net welfare change, and that's what I'm 12 sure you don't like because -- 13 DR. WOODBURY: That's exactly what 14 I don't like. That's right. 15 DR. HUBBELL: But you're right; 16 the consumers benefit when there's higher 17 yields. They do because the prices go down. 18 DR. WOODBURY: So, with this kind 19 of model, if we only have one soybean, it 20 will be extremely valuable, and it won't, you 21 know, doesn't matter. 22 DR. GRANTZ: There is the other

### 202-234-4433 Neal R. Gross & Co., Inc. Page 279 1 issue that if yields go down, you're using 2 more and more marginal land to produce enough 3 food to feed people. So, there are much 4 larger scale issues here. 5 DR. HUBBELL: There are very large 6 scale issues. 7 DR. GRANTZ: Let me just finish. 8 And it also depends an awful lot on the crops 9 that you are discussing. For example, in 10 parts of California, we grow 100 percent of 11 the country's supply of a lot of different 12 things. So, it makes a big different whether 13 it's that or whether it's a commodity that's 14 grown everywhere.

15 DR. HUBBELL: Yes. 16 DR. GRANTZ: So, I tend to think 17 the economic modeling makes an awful lot of 18 sense because it's actually what people will 19 pay attention to, and it provides a uniform 20 currency, so to speak, across all these 21 climates. 22 DR. HUBBELL: Thank you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 280 1 DR. WOODBURY: So, I had similar 2 questions about the I-tree model. I think I'm 3 familiar with -- the progenitor to this was 4 called U4. I believe that's the same -- so, 5 again, I would say what are the -- what are 6 the sensitive impacts in urban areas that 7 you're looking at and does this model really 8 allow you to get at that in a way where you're 9 really getting a robust estimate out the other

10 end? 11 So, for example, interactions with 12 temperature and moisture status will be 13 critical, I think, for ozone impacts on 14 vegetation wherever it occurs, including urban 15 areas. I'm sure this model is not accounting 16 for any of those interactions.

17 So we've had some sort of 18 discussion of sensitivity analysis, 19 uncertainty analysis. I guess I would hope 20 that the approach for this upcoming analysis 21 will -- will sort of take into account the 22 discussion we've already had on the human

### 202-234-4433 Neal R. Gross & Co., Inc. Page 281 1 health side. Some of these same issues. 2 Quantitative uncertainty analysis 3 is, I think, going to be more helpful than 4 sensitivity analysis per se, if the definition 5 is that sensitivity analysis is investigating 6 the sensitivity of a model to changes in the 7 input without any regard for the likelihood of 8 those changes. 9 So just an encouragement to again 10 think about quantitative uncertainty analysis 11 for the factors that are important, and pay 12 equal attention to potential sources of bias 13 and interactions among variable. I think 14 those, again, can have a lot of impact on the 15 outcome. Whether variables are correlated or 16 not and do we understand that, is just as 17 important as how many variables get treated as 18 probabilistic values. 19 So I think some of the sources of 20 uncertainty, you've got a list there, and 21 again, I just encourage you to look back 22 through the discussion of today and yesterday

### 202-234-4433 Neal R. Gross & Co., Inc. Page 282 1 at some other sources of uncertainty. That's 2 it. Thanks. 3 DR. FREY: Okay, thank you. Let's 4 see. Next I guess David Grantz. The floor is 5 yours. 6 DR. GRANTZ: I'll try hard not to 7 repeat things we've been hammering on. The 8 big aspect of any welfare approach is going to 9 come back to the NCLAN and the tree growth 10 data because that's what we know, and 11 especially for the NCLAN crop data. That's 12 where we can actually do some real economic 13 modeling, and it's been done in the past and 14 probably will be done again. 15 So, I think it's very appropriate, 16 as we said yesterday, for the ISO study, to 17 use the NCLAN data, the CR functions that we 18 developed then. But again with the caveat 19 that I mentioned yesterday, that some of the 20 varieties that are available now are less 21 sensitive. And we discussed whether there's 22 actually published data on that. But

### 202-234-4433 Neal R. Gross & Co., Inc. Page 283 1 anecdotally they are less sensitive than they 2 were in the NCLAN days. 3 So, that's important and at least 4 should be considered during the sensitivity 5 type analyses. Going back to your Figure 1 or 6 2, visibility seemed -- not visibility, sorry. 7 Visible injury seems to have an awfully big 8 role in your model. It's in the second square 9 and it propagates everywhere. 10 I would be really careful with 11 visible injury. It doesn't correlate with 12 anything in terms of other measures of damage. 13 What it does correlate beautifully with is 14 aesthetic value. And so as you have these 15 willingness to pay studies in national parks 16 and elsewhere, and other types of recreational 17 uses, it's very important, and I would really 18 run with that if you can, to the extent that 19 you can. 20 I'd be very careful about using 21 that as a surrogate, and I kind of see that 22 slipping in here. It's not a very good

### 202-234-4433 Neal R. Gross & Co., Inc. Page 284 1 surrogate for much else, actually. 2 Oh, let's see here. Yes, then we 3 get back to the thing I beat on yesterday with 4 stomatal conductance. I think, first of all, 5 as we discussed yesterday, the ISA is going to 6 have to go back. The author is going to have 7 to go back and reconsider really what we know 8 about the effective ozone on stomatal 9 conductance, whether it's up, whether it's 10 down, whether that's species or condition 11 sensitive. But I don't think you better take 12 the stream flow data from Sandy McLaughlin's 13 study and run with it, and I think that's what 14 your diagram indicates. 15 I think that would be -- would 16 open you to tremendous criticism. It's not 17 going to be justifiable, I think. 18 And then the last thing I wanted 19 to say simply is that -- and as you're well 20 aware, many of these things are not going to 21 be able to be monetized very easily. But 22 don't let that discourage you. I think we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 285 1 really have to make a stab at how things might 2 be, and in my written comments, I use the 3 example of bees. 4 We don't really know that ozone -- 5 you know, eats up pheromones or whatever, so 6 that bees can't track, but it might. And if 7 it did, that could be monetized in terms of 8 pollination services, which are a fee for 9 service. 10 So, there are little tricks like 11 that that you might be able to use, but in 12 general, aside from some of the NCLAN data, 13 you're going to have a very hard time putting 14 dollars on this. But I encourage you to take 15 the first step to do that. 16 DR. HUBBELL: If I might ask a 17 question about the declining sensitivity. You 18 said that's not published yet or it is 19 published? 20 DR. GRANTZ: Well, we were talking 21 with Jeff about that yesterday. It's sort of 22 known. People know that if you have ozone-

### 202-234-4433 Neal R. Gross & Co., Inc. Page 286 1 sensitive cultivar, you don't grow it as the 2 ozone goes up. So, I have my own lab data on 3 various cotton varieties in California, and 4 the new ones are less sensitive than the old 5 ones, but I don't know that that's in the 6 published literature. It's not from us. 7 DR. HUBBELL: One question I have 8 about that, just because this is something 9 that we've talked about for several years now, 10 is that I would expect that was certainly true 11 up until the introduction of the genetically 12 modified varieties, but for the GMOs, unless 13 they've dramatically changed the way they're 14 doing this, which they may have, is that they 15 had a much more limited set of varietals that 16 were regional-specific varietals at first 17 because they're producing these lines.

18 It used to be farmers would save 19 their seed, and they would save a fraction, 20 and they would develop their own varieties 21 based off of the hybrids that they had, and so 22 forth. But that wasn't occurring, at least in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 287 1 the first six or seven years of the 2 introduction of the GM crops. 3 And I'm wondering whether that has 4 bred out the ozone tolerance that you're not 5 getting the same tolerance since you're 6 stacking for different traits. 7 DR. GRANTZ: Well, that will 8 depend on the baseline variety into which 9 they're putting these traits. Remember that 10 NCLAN was done in the '70's. 11 DR. HUBBELL: Right. And overall, 12 if you think that overall nationwide, you've 13 got less -- less ozone sensitive, then that 14 would make some sense. If they were -- you're 15 right. Based on the seed -- 16 DR. GRANTZ: Well, it's anecdotal. 17 I can't point to a published paper. 18 DR. HUBBELL: Okay. 19 DR. GRANTZ: Although I will look 20 into that. Maybe there is some data. But 21 there's a lot of anecdotes of varieties that 22 were just dropped from production. There's a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 288 1 famous potato variety that John Skelly always

2 talked about. 3 DR. HUBBELL: And I just don't 4 know which ones they started with. 5 DR. GRANTZ: So, I can tell you 6 that the original Pima cotton varieties that 7 came into California from Arizona were 8 selected without ozone, and were extremely 9 ozone sensitive. Since then, they've selected 10 ozone varieties from that parental stock in 11 California, and it's much more ozone 12 resistant.

13 DR. HUBBELL: Are those the ones 14 they're using to put BT in for the -- the -- 15 DR. GRANTZ: To some extent, some 16 of the PhytoGen lines, yes. 17 DR. HUBBELL: Okay, all right. I 18 would be really interested to see if they -- 19 if there's actually been publications on that.

20 We would love to -- 21 DR. GRANTZ: Yes, that's a 22 problem. I'm not sure that there has been.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 289 1 For one thing, because nobody's doing ozone 2 studies in crops like that anymore. There's 3 no funding. 4 DR. HUBBELL: Right. But at least 5 if we could figure out -- I guess if we could 6 figure out which varieties they ended up 7 putting the genes into for the -- for the -- 8 because you know for soybeans, the last time 9 I heard, it was almost an 80 percent or more10 of the crop was being planted to the Roundup11 ready soybeans, and for cotton, it wasn't 12 nearly as much. But for certain parts of the 13 country, it's a lot. 14 DR. GRANTZ: For soybeans, 15 apparently, there hasn't been a real change in 16 sensitivity.

17 DR. HUBBELL: Yes. 18 DR. GRANTZ: But in cotton, I 19 believe there is. 20 DR. HUBBELL: All right. 21 DR. GRANTZ: Thank you.

22 DR. FREY: Howard?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 290 1 DR. NEUFELD: Thank you. I'll try 2 to hit on what hasn't been hit on so far. I 3 have a question about the model, the FASOM, 4 and the other models you're using. And I 5 threw in here -- and I'm not a modeler, so 6 this may be useless. But Huang Chen at Auburn 7 has this model DLEM, Dynamic Land Ecosystem

8 Model. 9 So, he's been looking at using 10 that to estimate, say, ozone impacts on 11 forests in China, on carbon storage and growth 12 and productivity, Smoky Mountains also. I 13 understand its physiological component uses 14 PNEC, but it seems to me that it might be 15 adaptable. It might be able to -- you stick 16 TREGRO instead, or something like that. But 17 anyway, I suggest you look into that model, 18 because it's been published a lot in recent 19 years. 20 We had a paper just came out on 21 China few weeks ago. It looks like a really 22 good model. I'm trying to remember back to my

### 202-234-4433 Neal R. Gross & Co., Inc. Page 291 1 forestry days, but foresters would go out and 2 measure growth and so on at their established 3 plots and they always have a certain error 4 associated with that growth, and it's fairly 5 low on a yearly basis. 6 So I'm wondering about signal to 7 noise ratio here. You know, how do you 8 separate out just the normal variation from a 9 signal due to ozone? Because you may, over 70 10 years, you might see a significant impact on 11 the growth of the tree, but on any particular 12 year, how would you distinguish the noise from 13 the signal? That's a difficult thing to 14 reconcile. 15 I'd argue as a botanist that there 16 might very well be a threshold, and Dave and 17 I were talking ozone. They might even like a 18 little ozone. It may stimulate the 19 antioxidant defenses against pathogens and 20 other things. May even then predispose them 21 to be less sensitive to ozone. 22 Something to consider; I talked to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 292 1 Henry Lee about this, where some of the NCLAN 2 studies showed an increase in ozone at the 3 lowest level of ozone exposure, and then it

4 went back down. 5 DR. HUBBELL: An increase in? 6 DR. NEUFELD: In yield or biomass. 7 And -- but Henry said at the time when -- when 8 -- if those studies were repeated, about half 9 the time that disappeared. So, it's not clear 10 if that's real or it was just an artifact of 11 maybe that chamber happened to be in a funny 12 position in the field. Things like that. 13 I think I'm a little leery about - 14 - and there's no alternative, so you just have 15 to deal with it, but the fact that Peter 16 brought up the idea we just have seedlings to 17 work with to develop the impacts on adult

18 trees. 19 There is that one study Art has, 20 looking at growth rings of adult tulip poplar 21 in the Smokies and black cherry. But I would 22 think that seedlings' data may overestimate

### 202-234-4433 Neal R. Gross & Co., Inc. Page 293 1 the actual mature tree response for a variety

2 of reasons. 3 The biggest one being the 4 depletion of ozone through the canopy so that 5 where you expose a seedling, every single leaf 6 gets the high ozone, but in a forest canopy, 7 only the outer leaves are getting that ozone. 8 Then it's depleted down through the canopy so 9 that the tree is not seeing the profile that 10 the monitor is telling you. 11 And also, I would just emphasize 12 that the only study I know of in the 13 literature showing the adult tree more 14 sensitive than the seedling is the one on the 15 red oaks by Samuelson and Hanson. I don't 16 know of any other studies, so I would be 17 careful about generalizing that to all three 18 species. 19 I'm going to be a little heretical 20 here. I worked in the national parks, you 21 know, and we were right on the main trail at 22 Clingman's Dome. Thousands of people would go

### 202-234-4433 Neal R. Gross & Co., Inc. Page 294 1 by and look at us measuring things on plants, 2 and think we were crazy, and what were we 3 doing and stuff. 4 I don't think a single person, 5 unless they were -- the only person who ever 6 knew what we were doing was Lyle Krieger, who 7 40 years ago was working on ozone, and he just 8 happened to be on vacation. But I would 9 guarantee, I would take the money in your 10 wallet and bet that not a single -- 11 DR. MILLER: Sixty-two dollars. 12 DR. NEUFELD: Sixty-two dollars. 13 I'll be $62.00 not a single person you asked 14 walking on the trail to Clingman's Dome would 15 even A, know what foliar injury is to ozone, 16 or 2, would care, or would even ever see it. 17 Now, if you showed them a healthy 18 leaf and an injured leaf, and asked them which 19 they're prefer, they would tell you. But 20 anyone walking in the park is there to look at 21 the views. They're not going to see foliar 22 injury. And on adult trees, it's 150 feet up

### 202-234-4433 Neal R. Gross & Co., Inc. Page 295 1 in the air. I mean, Art had to hire tree 2 climbers to grab the leaves and drop them down 3 so they could assess the ozone injury. 4 So I'd be very careful about the 5 aesthetic impact. I mean to me, essentially 6 it is zero because people don't see it. 7 DR. HUBBELL: Is that true, do you 8 think, in all seasons, all places? Or places 9 that have leaf viewing as a primary activity, 10 would it have more impact in those areas? 11 DR. NEUFELD: Most people don't 12 look at leaves. They would look at flowers, 13 and even if the plant has foliar injury, 14 they're going to -- 15 DR. HUBBELL: Like in the fall? 16 DR. NEUFELD: In the fall, ozone 17 injury becomes masked by fall leaf color. And 18 so you can't tell. In fact, that's why we 19 don't do surveys in the fall after about the 20 end of August, because then you can't tell if

21 that's natural leaf senescence due to the 22 fall, or whether it's actually ozone injury.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 296 1 So I just think that the public 2 doesn't notice. I echo Dave's thing about 3 dealing realistically with the ozone 4 responses. I think that's important. 5 Ollinger's model assumes a linear decline, but 6 there's no model I know of that includes7 sluggishness or I would say non8 responsiveness, which I think it important. 9 Let me see if I have anything else 10 here that I -- oh, I don't know how you can 11 handle it, but I was thinking, "Okay, if 12 you're projecting what the impacts of ozone 13 are, CO2 is going up two ppm a year. We know 14 it ameliorates the ozone effects. 15 I don't know of any studies that 16 are looking at the tertiary interactions with 17 temperature. There are some data on 18 precipitation effects. You could use the 19 Palmer drought severity index if you're trying 20 to get an idea of what that's doing to the 21 responsiveness. It's going to mute the 22 response to ozone.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 297 1 So, on a large scale, you could 2 maybe get at least a handle qualitatively on 3 what you might expect in those kinds of years. 4 I'm not sure what you mean by the percent of 5 trails affected by ozone injury. I think 6 that's where you're trying to get this 7 aesthetic impact, but I'm not sure that's a 8 useful way to go about it. 9 And related to crops, there are 10 some papers now coming out showing that 11 because of climate change, farmers are 12 extending their growing season, planting 13 earlier, going farther in the fall. So I 14 don't know if you're accounting for that in 15 the models. I don't know if that increases 16 yield, or how that affects yield. 17 And those are most of my comments. 18 Otherwise, I thought this was a -- it's an 19 ambitious plan. So -- but I thought it was

20 well done. 21 DR. GRANTZ: Can I make a couple 22 of quick comments?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 298 1 DR. FREY: Yes, sure. Go ahead, 2 David.

3 DR. GRANTZ: Just related to 4 things that Howie said, I agree with almost 5 everything Howie said, but I think the 6 aesthetic aspect is perhaps more important 7 than, for example, Sequoia Kings Canyon, where 8 we see leaves retained for two years instead 9 of six years, things like that. 10 And so, when you look up, which 11 everybody does, walking in the pine forest or 12 a redwood forest, is a big difference. Plus, 13 we're seeing browning, leaf browning for a 14 number of reasons, some of which may be

15 related to ozone. 16 The other is this important point 17 of gradients of ozone through canopies. It is 18 true there's a substantial depletion of ozone 19 as you go vertically through a canopy, and 20 we've shown this even in a cotton canopy, 21 which is only a meter tall. 22 But it is also important to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 299 1 remember that light declines even faster. So, 2 the photosynthesis is weighted on the outside 3 where the ozone is. So the effect in a 4 practical sense is possibly not as big as 5 Howie implied. 6 DR. FREY: Okay, Kathy, are you 7 still with us on the phone? 8 DR. WEATHERS: Yes, I am. The 9 challenge of being the caboose is that 10 everyone has said the kinds of -- made the 11 kinds of points I like to make. So I'll just 12 underscore very quickly three of the 13 overarching points. 14 DR. FREY: Okay. 15 DR. WEATHERS: So, again, 16 underscoring what Ted had to say about being 17 very clear about debiasing the models, and 18 where the sensitivities are I think is also 19 something I'd like to see. Said that before

20 as well. 21 And taking that one step further, 22 most of this analysis will be about linking

### 202-234-4433 Neal R. Gross & Co., Inc. Page 300 1 models. And that's a huge challenge and will 2 be a challenge in this analysis. And so 3 reviewing the process, so kind of taking the 4 debiasing and sensitivity analyses steps 5 further and applying them to the model 6 linkages, I think, will be incredibly 7 important as well. 8 So, it's not always clear that the 9 spatial or the temporal or just the data 10 output from one model, how it interfaces with 11 running another model. The -- the ozone 12 surface modeling is a great example of that. 13 So, linking models and the process 14 by which models will be linked, I think, needs 15 to be addressed. I agree with Peter as well 16 about species effects and lack of data, and 17 also about focusing on ecosystems services. 18 I think that biomass, maybe with 19 the exception of ag systems, or water, 20 especially at the watershed scale, looking at 21 the effects of ozone is going to be very, very 22 difficult. So I think it's worth

### 202-234-4433 Neal R. Gross & Co., Inc. Page 301 1 reconsidering some parts of the ecosystems 2 services that you're looking to make links to, 3 even indirect links. 4 And I think those are the main 5 points that I'd like to make. So I agree with 6 David and Howard and Peter and Ted's comments. 7 DR. FREY: Okay, great. Howard?

8 DR. NEUFELD: Just one other 9 thing. Can you just -- I'm not sure I 10 remember if you mentioned this or not, but in 11 terms of the elevational component, you also 12 changed the -- when you're doing, say, 13 simulations or models, will you change the 14 dynamic of the ozone exposure from the 15 sinusoidal kind of pattern at low elevations, 16 or the flat pattern at high elevation? 17 DR. HUBBELL: Yes, I don't know 18 that we've worked through all the way, but to 19 the extent that we're doing the gridded20 estimates of hourly ozone, it would -- grid21 by-grid, if it's a grid that's over a high 22 elevation, it'll reflect that profile, versus

### 202-234-4433 Neal R. Gross & Co., Inc. Page 302 1 at the lower elevations it'll have a different 2 profile.3 So, it's grid-by-grid and hour-by4 hour. So, to the extent that the model is 5 capturing that, it'll be in the profile. I 6 don't know how other models capture that. I'm 7 just not sure.

8 DR. FREY: Other comments? The 9 floor is open. Brian and Travis, is there 10 anything you were hoping to hear feedback on 11 that hasn't been addressed yet? 12 DR. HUBBELL: I don't think so. I 13 think we've got a lot of really great 14 information. And again, certainly encourage 15 if you think of other publications that would 16 be helpful to fill in some of these data gaps, 17 please provide those, as they'll be really, 18 really helpful. 19 DR. FREY: Okay, last chance. 20 DR. STALLWORTH: We're adjourned. 21 DR. FREY: All Right. Thank you. 22 DR. HUBBELL: Thanks very much to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 303 1 the panel for both the discussions yesterday 2 and today. They've been extremely helpful for 3 EPA. Appreciate it. 4 DR. FREY: And just remember: your 5 written comments are due June third. 6 (Whereupon, the foregoing matter 7 when off the record at 2:10 p.m.)

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289:9 80s 254:2 85 62:15 9 9 89:16 105:14 90s 247:10 92 67:11 95 207:1 98th 64:12NEAL 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 345

Ozone Review Panel

US EPA Clean Air Advisory Committee

05-20-11

Chapel Hill, NC