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

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## U.S. ENVIRONMENTAL PROTECTION AGENCY
+ + + + + CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

PARTICULATE MATTER REVIEW PANEL

+ + + + +

PUBLIC MEETING

+ + + + + THURSDAY, MARCH 11, 2010
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The meeting convened in Salon ABC of the Marriott Research Triangle Park, 4700 Guardian Drive, Durham, North Carolina, at 8:00 a.m., Jonathan Samet, Chair, presiding. CASAC MEMBERS PRESENT:

JONATHAN SAMET, Chair JOSEPH BRAIN H. CHRISTOPHER FREY ARMISTEAD RUSSELL HELEN SUH202-234-4433 Neal R. Gross & Co., Inc. Page 2

PANEL MEMBERS PRESENT:

LOWELL ASHBAUGH ED AVOL WAYNE CASCIO

DAVID GRANTZ ROGENE HENDERSON MORTON LIPPMANN ROBERT PHALEN RICH POIROT FRANK SPEIZER SVERRE VEDAL

SCIENCE ADVISORY BOARD STAFF:

HOLLY STALLWORTH, Designated Federal Officer Page 3

TABLE OF CONTENTS AGENDA ITEM PAGE Overview of Policy Assessment . . . . . . . . .5 (Chapters 4-5) Highlights of Urban-Focused Visibility. . . . 41 Assessment OAQPS: Dr. Karen Martin Ms. Vicki Sandiford Dr. Marc Pitchford
Public Comment on UFVA. . . . . . . . . . . . 72 Charge Question #1. . . . . . . . . . . . . .112 Dr. Lowell Ashbaugh Dr. Philip Hopke Dr. David Grantz Charge Question #2. . . . . . . . . . . . . .120 Dr. Chris Frey Mr. Tom Moore Dr. Lowell Ashbaugh Charge Question #3. . . . . . . . . . . . . .115 Mr. Tom Moore Mr. Rich Poirot Charge Question #4. . . . . . . . . . . . . .117 Mr. Richard Poirot Mr. Tom Moore Dr. Lowell Ashbaugh Highlights and Discussion of Charge . . . . .131 Questions for Upcoming Review of Policy Assessment OAQPS: Dr. Karen Martin Ms. Beth Hassett-Sipple Adjourn Page 4

1 P-R-O-C-E-E-D-I-N-G-S 2 (8:05 a.m.) 3 CHAIRMAN SAMET: So here's what 4 we're going to do. We are sticking with the 5 schedule in terms of times for public 6 comments. Remember, we have two public 7 commenters still on visibility. Tom is going
8 to call. And we need to hear from Tom. 9 So in the meantime, what we are 10 going to do is look at the draft letters to 11 the administrator. So remember that we have 12 been presenting our main comments in the body 13 of a relatively brief letter attaching 14 comments, then the responses to the charge 15 questions, and then the comments of the 16 individual panelists.
17 So we have draft letters to look 18 at that are in front of you in hard copy. So 19 what we would like to do is go over the main 20 points of these letters. 21 Let's try not to engage in group 22 wordsmithing. I know it's hard not to, but
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1 it's probably not what we need to do. In 2 fact, Holly and I would discourage it at any 3 time. I think we spent probably two months 4 sort of post-meeting time doing wordsmithing. 5 I recognize that these texts can 6 always be improved and our letters made ever 7 more splendid. However, there comes a time. 8 DR. STALLWORTH: And also the 9 conference code has changed this morning. 10 It's 044B15. 11 CHAIRMAN SAMET: Although I don't 12 know why anybody would want to be doing their 13 e-mails when they could be wordsmithing the 14 letters. 15 OVERVIEW OF POLICY ASSESSMENT (CHAPTERS 4-5) 16 CHAIRMAN SAMET: Okay. So why 17 don't we start. The one that's labeled 18 "Samet," let's start with that. So this was 19 on the risk assessment. 20 Actually, when I wrote it, I was 21 -- you can ignore some of this because I was 22 thinking of a joint two letter on the two202-234-4433 Neal R. Gross & Co., Inc. Page 6

1 documents. 2 And what we have done, actually, 3 is at the moment, there would be two separate 4 letters. And, Holly, I don't know if it's 5 best to have one or two. 6 DR. STALLWORTH: Two. 7 CHAIRMAN SAMET: Two. Okay. So 8 consider this to be the letter on the risk 9 assessment. Okay. It's gone. There had been 10 a paragraph on the thing. 11 I had tried to put in here, I 12 think, beyond saying that we thought the 13 document was improved and with final revisions 14 would be ready to become final, then I thought 15 these were our main points. But if I have 16 missed something, sort of main points, in 17 part, that over-arch, that go beyond the 18 charge question, so they were this question 19 about the peak shaving proportional approach 20 and the hybrid approach and addressing the 21 fact that these were not well-explained, they 22 need to be explained better, and perhaps it Page 7 1 was I think the hybrid approach findings that 2 we thought merited the greatest emphasis. 3 So there was that. There was the 4 point raised originally by Frank about chapter 5 5 and the discussion there to move that to an 6 appendix while keeping that one sort of risk 7 distribution graph that places the 15 8 communities on it. 9 The question about how low to go 10 -- and that had to do with going below 12 -- 11 and then just making chapter 6 better, saying 12 it is important, but it just needed to be more 13 clearly written. 14 So if there are other main points 15 that the group thinks should be added, please 16 let's raise them now. And then let's also go 17 through what is said here. 18 So maybe the first point is, are 19 there other sort of big issues? Remember, we 20 have the responses to the charge questions as 21 well. 22 MR. AVOL: I think you have Page 8 1 captured it. 2 CHAIRMAN SAMET: So we can 3 certainly revisit this. So then why don't we 4 if everybody is ready maybe take a look at the 5 bullets? So just the first bullet? And this 6 had to do with the presentation of these 7 approaches for the meeting, the suites of 8 standards. 9 DR. VEDAL: You know, there was a 10 point that was made yesterday about not 11 sufficient clarify. But I agree with Lowell 12 or someone yesterday said that they are 13 presented pretty clearly at one point, 14 well-defined, and about what they actually 15 mean or how they are actually done. 16 You don't think so, Ted? 17 DR. RUSSELL: No. 18 DR. VEDAL: I mean, I read it, but 19 I think I understood it. But you think they 20 need more detail? 21 DR. RUSSELL: Well, the peak 22 shaving approach is not well-described. Page 9

1 DR. VEDAL: But I think what they 2 answered is what it says in the text. 3 DR. ASHBAUGH: I think part of the 4 problem is the name. 5 DR. VEDAL: Yes. Yes, that's 6 true. 7 DR. ASHBAUGH: And my first 8 thought when I saw the name was, yes, they 9 took Pete's off. And that's what Bill got 10 stuck on. But the text does explain that it 11 takes the top monitors and rolls them all 12 back. 13 DR. VEDAL: Yes. 14 DR. ASHBAUGH: But it probably 15 could be explained better and maybe with a 16 different name because that is confusing. 17 DR. RUSSELL: And the point I 18 think the three of us could have is if it did 19 show the mathematics of it, it would go a long 20 ways, either within the text or within 21 appendix B. Within appendix B, they don't 22 ever --202-234-4433 Neal R. Gross & Co., Inc. Page 10

1 DR. BRAIN: Can there be one data 2 set and then use the three approaches on a 3 single data set and show the outcome? 4 CHAIRMAN SAMET: That suggestion, 5 I mean, the -- 6 DR. RUSSELL: That is in response 7 to one of the -- 8 CHAIRMAN SAMET: Yes. 9 DR. RUSSELL: I think an example 10 would help. And they can put that in appendix 11 B. 12 CHAIRMAN SAMET: Yes. So I had 13 the sense here as CASAC founded these three 14 alternatives that were not defined in 15 sufficient clarity and recommended a 16 graphical, you would say graphical or 17 mathematical, approach along with the 18 inclusion of examples based on the 15 study 19 areas. 20 And I think that was -- I don't 21 think it is very clear. And I think if Phil 22 and Ted read it and don't find it clear and Page 11 1 they're confused -- 2 DR. ASHBAUGH: Yes. I agree. If 3 anyone finds that it's not clear, it's not 4 clear. I do think it was explained, but if 5 anybody doesn't get it right, it's not clear 6 enough. 7 CHAIRMAN SAMET: Ted, would you 8 like to recommend a graphical and/or 9 mathematical approach for definition? 10 DR. RUSSELL: Yes. Do you want to 11 put that in responses to the charge questions 12 or do you want it -- 13 CHAIRMAN SAMET: Well, it's in my 14 letter, it's in the overall letter, right now. 15 I can just modify it and say "graphical and/or 16 mathematical approach." I mean, it's just -- 17 DR. RUSSELL: Yes. That would be 18 good. 19 CHAIRMAN SAMET: Okay. The text 20 does suggest a name besides "peak shaving" 21 because that was -- 22 DR. VEDAL: Yes. That's good. Page 12
1 CHAIRMAN SAMET: So then the next 2 bullet is on chapter 5. Between Frank and I, 3 we did all write something that will go into 4 the -- I guess it's not really a charge 5 question, but we would just add it as an 6 additional comment. 7 And this captures that, just 8 saying that we think the chapter should be an 9 appendix. And then this key part about 10 generalizability will just be brought into 11 chapter 6. 12 And then the third bullet I think 13 is an important one. This had to do with our 14 somewhat lengthy discussion yesterday about 15 extending the risk assessment counterfactuals 16 or scenarios to levels below 12. 17 What would be the basis for 18 deciding this how low to go question and that 19 the document didn't not make clear what was 20 the basis for picking the scenarios except, I 21 mean, I think we recognized that these were 22 put forward as potential 24-hour and annual Page 13 1 standards. And then there was an expiration 2 of them. But that's perhaps not the right 3 logic. 4 So the key here is that this last 5 couple of sentences, "We recommended EPA 6 develop and apply specific criteria for 7 determining the exposure concentration values 8 to be considered in the risk assessment. 9 Mounting uncertainty at lower concentrations 10 would be a reasonable basis for doing so. 11 That was just a sort of a suggestion about how 12 to go. So the proposal is that they do 13 something and that it be explicit." 14 DR. LIPPMANN: You only talk about 15 the annual, 12. In the introduction, you 16 talked about 24-hour and annual. And perhaps 17 we need a few more words to say that as you 18 get down to 12 and below, the annual tends to 19 be controlling and is the most critical -- 20 CHAIRMAN SAMET: Okay. 21 DR. LIPPMANN: -- or that using 22 the 24-hour leads to annual levels in peaking202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 cities that are extraordinarily low. 2 DR. VEDAL: Well, that doesn't 3 need to be here. I mean, that's throughout -- 4 CHAIRMAN SAMET: I think probably 5 I can see Mort's point that the discussion is 6 largely about the annual and not about -- 7 DR. LIPPMANN: I mean, you need to 8 say a few words at least about why you're 9 concentrating on the annual. 10 DR. STALLWORTH: Because it's 11 controlling when you go down -- 12 CHAIRMAN SAMET: Yes, yes, yes. 13 DR. STALLWORTH: Thank you. I'll 14 have to put a sentence in there. 15 DR. VEDAL: Well, not really. 16 It's because, I mean, the argument in favor is 17 because it provides more consistent public 18 health protection. They both could be 19 controlling with enough lowering standard. 20 DR. LIPPMANN: Right. I think 21 just to make a note to expand on that a little 22 bit. Page 15

1 DR. STALLWORTH: Thank you. 2 CHAIRMAN SAMET: And there 3 probably should be a sentence. I mean, we 4 should say recommend that EPA develop and 5 apply specific criteria. Maybe we should 6 probably have a third sentence that just says 7 the text should clearly specify the basis for 8 decision-making or something, something like 9 that at the very end. 10 DR. PHALEN: Jon, I hope that you 11 wouldn't think of this as wordsmithing. I 12 think of it as more concept-smithing, but on 13 the first line, the current risk assessment 14 explores the burden of disease that can be 15 avoided. And that is awfully confident for 16 me. 17 I would say it explores the 18 potential for avoiding disease burden because 19 it makes it sound like the risk assessment is 20 exploring disease burden. 21 CHAIRMAN SAMET: So why don't we 22 say explores the burden of disease estimated Page 16 1 to be avoidable or something like that? 2 DR. PHALEN: Perfect. Thanks, 3 Jon. Thank you. 4 CHAIRMAN SAMET: Yes, yes. We 5 actually don't have a definition of 6 wordsmithing yet. 7 DR. PHALEN: Good. We will. 8 CHAIRMAN SAMET: But we will, sir. 9 You can write it. So we had several 10 modifications this morning, just a little 11 balance around the 24-hour annual thing that 12 includes the last sentence in responding to 13 Bob's comment. 14 Okay. And then the last, it says 15 make chapter 6 as good as possible. 16 DR. STALLWORTH: And we can come 17 back to this after we go through the charge 18 questions. 19 CHAIRMAN SAMET: Yes, yes. Okay. 20 So if these are roughly okay and no one has 21 any new bullets to add, let's maybe go on. 22 Rich, do you want to sort of talk about the -- Page 17 1 DR. STALLWORTH: Do you want to 2 walk through this one? 3 CHAIRMAN SAMET: Do you want to do 4 that? I was thinking about giving them a 5 list. Okay. That's fine. So we'll do the 6 charge questions, then. 7 All right. So we're going to go. 8 Turn the page. We're going to go on to the 9 risk assessment charge questions. Okay. So 10 we have for question 1A, we have comments from 11 Ted. So why don't we take a minute on this 12 first page? 13 So the first one really speaks to 14 the point we had already. 15 DR. RUSSELL: Making that 16 consistent with what we already have. 17 CHAIRMAN SAMET: Right. 18 DR. RUSSELL: So coming up with an 19 alternative label. I think it says pretty 20 much the same thing. 21 CHAIRMAN SAMET: Yes, it does. 22 And so we might just add to come up with202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 another name for it, too, how to get that. 2 Okay. So those are mine. And then -- 3 DR. SPEIZER: Can I ask a question 4 here? Do we need in this cover letter to hit 5 every charge question as though it's an 6 independent response to each one? I mean, is 7 that required of us? Do we want to do that 8 first? 9 CHAIRMAN SAMET: Well, we have 10 been doing it. I mean, we have been 11 responding to each charge question. 12 DR. SPEIZER: But we have got 13 those, all the individual responses. 14 DR. STALLWORTH: But this is 15 CASAC's consensus response -- 16 CHAIRMAN SAMET: This is our 17 consensus. This is our response. 18 DR. STALLWORTH: -- to charge 19 questions. 20 DR. SPEIZER: Okay. So you want a 21 consensus response to the charge questions? 22 DR. STALLWORTH: That's correct. Page 19 1 DR. LIPPMANN: Well, the names 2 here are the leader who -- 3 DR. STALLWORTH: Yes. I inserted 4 names just to help.
5 CHAIRMAN SAMET: Yes. 6 DR. STALLWORTH: Obviously I'll 7 delete the names. I wanted to keep -- 8 CHAIRMAN SAMET: Well 9 DR. SPEIZER: Yes. I don't have 10 to take exception to what we include. That's 11 all right. Go ahead. I just don't -- 12 CHAIRMAN SAMET: This is no 13 different than what we have been doing. 14 DR. SPEIZER: Well, I guess maybe 15 my short-term memory is getting shorter. 16 CHAIRMAN SAMET: No. Because what 17 we have been doing is asking sort of the lead 18 person on each charge question to -- 19 DR. SPEIZER: Well, I know, but 20 this is a letter to the administrator. 21 CHAIRMAN SAMET: Oh, no. We are 22 moving beyond the letter now. Page 20
1 DR. SPEIZER: This is not the 2 letter to the administrator? 3 CHAIRMAN SAMET: No. 4 DR. STALLWORTH: This is the 5 attachment to the letter. 6 CHAIRMAN SAMET: This is the 7 attachment. 8 DR. SPEIZER: Okay. I'm sorry. 9 I'm sorry. 10 CHAIRMAN SAMET: Okay. So the 11 four bullets we just went over would be the 12 letter plus the boilerplate stuff. Okay. So 13 these are the responses. 14 So we had done the first one, 15 which was actually the bullet in the -- same 16 as the bullet more or less. And then the next 17 is the response to B. And that's right. We 18 had the discussion about missing values. 19 Okay. So any comments here? 20 DR. LIPPMANN: On the second line, 21 I think "motivates" is not the right word, 22 something like "clarify the basis for," Page 21

1 instead of "to help motivate." 2 CHAIRMAN SAMET: That's the 3 meaning of it, Ted, right? 4 DR. BRAIN: To add confidence to 5 the analysis. 6 CHAIRMAN SAMET: Justify. 7 DR. BRAIN: To justify the 8 procedures. 9 CHAIRMAN SAMET: I think this 10 qualifies for wordsmithing, but I think we 11 will get rid of "motivate." Okay. "Explain" 12 or something. Anything else on this one? 13 (No response.) 14 CHAIRMAN SAMET: Okay. Then the 15 next, it's charge question 2, selection model 16 inputs. And here is a response developed by 17 Morton 18 DR. LIPPMANN: With wordsmith 19 taken from Wayne and Helen fit into what we 20 discussed in the background. I think you used 21 some edge words here and there, too. 22 CHAIRMAN SAMET: Okay. Good with202-234-4433 Neal R. Gross & Co., Inc. Page 22
1 this one? Then next. 2 DR. VEDAL: This wasn't the place 3 to comment about the socioeconomic status 4 issues. 5 CHAIRMAN SAMET: The adjustment 6 issue questions? 7 DR. VEDAL: Yes. Did that come 8 later? 9 DR. STALLWORTH: I think that's 10 later. 11 DR. VEDAL: All right. It's 12 really, I think, in 6. 13 DR. STALLWORTH: I think that's in 14 the next one. 15 CHAIRMAN SAMET: Okay. So charge 16 question 3 is uncertainty and variability. 17 Chris is teaching and will be in a few hours. 18 This is Chris' response. 19 DR. VEDAL: Should we wait on 20 that? 21 CHAIRMAN SAMET: No. I would 22 suggest that we look at it now because I think Page 23 1 he's 10:30 plus to get here. 2 DR. STALLWORTH: And I 3 incorporated Chris'. This is his second 4 version that incorporates your comments. 5 DR. SUH: Thank you. 6 DR. STALLWORTH: There's a mention 7 of socioeconomic status here. 8 DR. BRAIN: It seems like some of 9 this should go into his own comments. 10 DR. STALLWORTH: Yes. Some of it 11 probably should. 12 DR. BRAIN: It needs to be 13 condensed and more focused on -- 14 DR. VEDAL: And much of that third 15 paragraph is sort of specific comments about 16 infiltrations and -- 17 DR. BRAIN: Yes. It doesn't 18 really tell them what they should do. 19 DR. STALLWORTH: Okay. I'll mark 20 that and discuss it. 21 CHAIRMAN SAMET: So yes. It's 22 overly long, too. Actually, Chris always Page 24 1 writes a lot, which is useful, but in this 2 case, it might get pared down a bit. 3 DR. STALLWORTH: Right. 4 DR. PHALEN: Jon, this is the one 5 with infiltration rights, right? 6 CHAIRMAN SAMET: Right. 7 DR. PHALEN: Does anyone object to 8 talk about air exchange rates, rather than 9 infiltration rates, or using air exchange 10 rates, instead of infiltration? It's not a 11 one-way process. 12 CHAIRMAN SAMET: Good point. And 13 this probably is something that might be in 14 the specific comments. We can ask Chris to 15 pare this down a little bit. 16 Yes, sure. Air -- 17 DR. PHALEN: Yes. Think about the 18 concept because it sounds like it's a one-way 19 process that, as opposed to air exchange -- 20 MR. AVOL: Although the regulatory 21 premise here is outdoor. 22 DR. PHALEN: Pardon? Page 25

1 MR. AVOL: The regulatory premise 2 here is outdoor. So it's outdoor -- 3 DR. PHALEN: No. I understand. 4 No. I know that. But, you know, as many 5 studies have shown, you know, when you're 6 talking about risk, you know, the x city 7 studies, for example, have shown that there 8 are indoor areas, too. And if we don't 9 consider that, we're not considering the full 10 range of risks. 11 Plus, it's just more accurate 12 scientifically if you're modeling air 13 exchange, rather than -- 14 DR. STALLWORTH: Okay. I made a 15 note of that. And we'll ask Chris to tighten 16 this up, maybe shorten it and export some of 17 the more minor comments to -- 18 CHAIRMAN SAMET: Yes, yes. I 19 mean, I think the major point is that, in 20 general, this was thought to have been done 21 well. That's probably his first paragraph and 22 then a few of the later --202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 DR. VEDAL: I think that paragraph 2 on the low, medium, and high could probably do 3 that through the sentences. 4 DR. STALLWORTH: Which one is 5 that, Sverre? 6 DR. VEDAL: The third one on the 7 second page of this, -- 8 DR. STALLWORTH: Okay. 9 DR. VEDAL: -- basically about 10 doing that and then how they achieve 11 consensus. I don't think that detail is 12 needed. 13 CHAIRMAN SAMET: Well, probably 14 this comment about staff consensus -- you 15 remember we had some discussion about that 16 yesterday -- is probably what is keeping it up 17 front. It should be probably defined. 18 Okay. Other things on Chris' 19 response? 20 DR. LIPPMANN: The last paragraph 21 that has a close bracket at the end, I don't 22 see where the bracket starts. Page 27

1 DR. STALLWORTH: Take it off. 2 CHAIRMAN SAMET: Okay. So charge 3 question 4 was the sensitivity analysis. 4 DR. STALLWORTH: It's also Chris. 5 CHAIRMAN SAMET: It's also Chris. 6 MR. AVOL: There is another row 7 bracketed at the end of this. 8 CHAIRMAN SAMET: Again, I think 9 the main points are the right ones. And 10 perhaps it could be streamlined a little bit, 11 but -- 12 DR. LIPPMANN: On the next page, 13 the last paragraph ends with "This might be 14 clarified." I don't think we want to say 15 "might." You know, we either say it should or 16 -- 17 CHAIRMAN SAMET: He has a 18 question. I think we should just take it off. 19 This might be clarified. 20 DR. STALLWORTH: Okay. 21 CHAIRMAN SAMET: Okay? Okay. So 22 move on to charge question 5. So, actually, Page 28 1 we have this piece of Sverre. And, then, 2 Sverre, your piece there, is that in response 3 to A and B or -- 4 DR. VEDAL: Yes. The discussion 5 of the second, yes, it is A and B because 6 recommendations are all largely B, things that 7 might be added. 8 DR. STALLWORTH: Okay. 9 DR. BRAIN: We kind of hint at it, 10 but do we want to be clear about wanting them 11 to put the 15 selected cities in the context 12 of the total topography of the U.S., you know, 13 to be a little clearer about that they're not 14 typical but that they're -- we talked about 15 that, but I don't see that really -- 16 CHAIRMAN SAMET: What they have 17 done -- and this goes back to that chapter 5 18 to sort of place some cities in the spectrum 19 and other distribution of PM-related risk. 20 With the BenMAP analysis, they have not 21 provided other demographics. 22 I guess the question, what would Page 29 1 you want to do? 2 DR. BRAIN: Mike sort of hints at 3 it when he talks about the generalizability of 4 the findings from the 15 areas, but, I mean, 5 it seems to be really -- should be clear -- 6 CHAIRMAN SAMET: For both? 7 DR. SUH: Well, this is where 8 Rogene had mentioned taking those pretty 9 graphs or pretty plots and adding a third 10 dimension -- 11 DR. HENDERSON: Third dimension. 12 DR. SUH: -- for the health. And 13 perhaps you're right. Maybe that's where the 14 chapter 5 plot goes in to show how the 15 15 cities fit within the whole scheme. 16 CHAIRMAN SAMET: So maybe the -- 17 and I think Helen goes on the same thing. The 18 question of establishing the generalizability 19 of the results in chapter 4, but that also has 20 to come back in chapter 6 because that is 21 still an important part of the integrated 22 summary.202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 So maybe there should be comment 2 to this in chapter 4 and again in chapter 6. 3 So maybe the comment there about chapter 5 is 4 probably correct, but we should suggest that 5 this be incorporated at the proper points in 6 both chapters 4 and 6. 7 And then the other question is, 8 should there be additional attempts to try and 9 place these 15 cities in the broader context 10 of U.S. cities and how would you usefully do 11 that? I mean, we know that cities are 12 different. 13 DR. VEDAL: I mean, what they have 14 done is put it in the context of air 15 pollution. 16 CHAIRMAN SAMET: Of air pollution 17 risk. 18 DR. VEDAL: I don't know how. 19 CHAIRMAN SAMET: Yes, which is a 20 reasonable thing to do, I think. 21 DR. VEDAL: Yes, yes, yes. But -- 22 DR. SUH: But if you put it -- Page 31 1 DR. VEDAL: So you would have to 2 identify some criteria that you wanted to and 3 then place them in the district. 4 CHAIRMAN SAMET: Yes. I was 5 thinking about how you could construct the 6 table. I guess it was Joe who started this 7 conversation. But what would be in the table, 8 you would have the 15 cities. And then you 9 would have the other X cities that somehow fit 10 the same range of population or of something. 11 I'm just not -- 12 DR. BRAIN: Or that they represent 13 populations that during the top quartile of 14 exposure or something, you know, something 15 like that. 16 CHAIRMAN SAMET: They've done that 17 with the risk stuff. They've done that with 18 that figure 5.4 because that is sort of an 19 exposure-based figure. 20 DR. LIPPMANN: While you are 21 thinking, Jon, in the beginning we said areas. 22 And now you're talking cities. And here it Page 32 1 says urban areas. I think for consistency, we 2 always ought to use urban areas because city 3 is not quite the right word. 4 CHAIRMAN SAMET: Okay. 5 DR. LIPPMANN: They usually are 6 SMAs. And area could be confusing left alone. 7 CHAIRMAN SAMET: They're referred 8 to in the document, I think, as urban study 9 areas. I think that's where that terminology 10 came from. 11 DR. LIPPMANN: In any case, urban 12 area -- 13 DR. VEDAL: Yes. I took it from 14 that text. 15 DR. LIPPMANN: You know -- Holly 16 go through and make sure that's uniformly 17 used. 18 CHAIRMAN SAMET: So good point. I 19 think what I would suggest is we use the EPA's 20 own terminology. 21 DR. LIPPMANN: Whatever term we 22 use should be used consistently. Page 33

1 DR. STALLWORTH: Urban study 2 areas? 3 CHAIRMAN SAMET: Urban study 4 areas, yes. Yes. 5 DR. HENDERSON: Jon, didn't they 6 have a paragraph in there telling how they 7 chose these cities, but one of the main things 8 was that they had health data on them, right? 9 I mean, you were talking about what delineated 10 the 15, but it was that we have information on 11 them concerning health effects, right? 12 CHAIRMAN SAMET: Yes, but I think 13 this text was largely having to do with the 14 representativeness, then, of those cities once 15 they were selected. And I'm not sure. They 16 were not selected to be "representative." 17 And maybe that would be helpful if 18 you were to add that the selection of these 19 cities was not made necessarily to assure 20 representativeness. And then the question 21 becomes what has been done to show how they 22 fit into the context of exposure risk. And202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 that's where this analysis in chapter 5 really 2 figures in as useful. 3 DR. SPEIZER: They're all NMAPS 4 cities, aren't they? And the ISA has a figure 5 on NMAPS. I wonder if it would be worth 6 pulling that figure in and highlighting these 7 cities in that context. That would actually 8 show where they fit in the figure of risk. 9 DR. LIPPMANN: And, pursuing 10 Rogene's point, how representative are they? 11 Tacoma was selected as a Western city. It's 12 hardly representative of Seattle, which is 13 much bigger. But it was data where suitable 14 data were available. 15 So that's an example of where it 16 was a convenience sample that could be 17 described as reasonably representative, but it 18 doesn't really -- 19 DR. SUH: I think the point was 20 that these 15 cities were representative. I 21 think it's just that they're not so anomalous 22 as compared to the rest of the other cities. Page 35 1 DR. LIPPMANN: Right. 2 DR. SUH: So I think it's good 3 just to put them into some sort of context, I 4 think, but I don't think there was ever a 5 claim that they were representative, though. 6 CHAIRMAN SAMET: And I think, 7 actually, that is probably the best context, 8 what probably was done, which is to try to put 9 them in this sort of exposure distribution. 10 I mean, it's exposure turned into risk by a 11 BenMAP, but I think -- 12 DR. VEDAL: Well, yes. I mean, I 13 wasn't really as enthusiastic about Rogene's 14 suggestion before, but thinking about it, I 15 think I am because the risk estimates are 16 based on these cities. 17 And if the risk estimates are just 18 inordinately different, say, based on the 19 distribution from NMAPS or whatever 20 distribution we have, that might color our 21 view of them. 22 DR. LIPPMANN: I noticed that in Page 36 1 these maps, these diagrams, Tacoma looks odd. 2 And it seemed like -- 3 DR. VEDAL: It is odd. 4 DR. LIPPMANN: -- not necessarily 5 the best choice. 6 CHAIRMAN SAMET: But we have to 7 remember that 15 cities aren't going to 8 change. 9 DR. LIPPMANN: No, no. 10 CHAIRMAN SAMET: And so the 11 question really is -- 12 DR. LIPPMANN: How to describe 13 them. 14 CHAIRMAN SAMET: -- how to 15 describe them. And I think in terms of this 16 analysis and this purpose, the figure of 17 exposure/risk is probably exactly the right 18 one. 19 DR. VEDAL: Right. I just don't 20 think we can get the risk on the same -- we 21 can ask them to put them on the same plot as 22 the one we have. It really dilutes the Page 37

1 message and just to complicate it, but 2 something to put it in the context of the risk 3 distribution would be. 4 CHAIRMAN SAMET: Well, that's 5 figure 5.4. 6 DR. SUH: Yes. To me, that is 7 actually perfect. 8 CHAIRMAN SAMET: Yes. It's done 9 in a different way. Well, that's the 10 suggestion that Frank and I made. 11 DR. VEDAL: Yes. 12 CHAIRMAN SAMET: I mean, figure 13 5.4, remember, is the BenMAP risk. 14 DR. VEDAL: Right. 15 CHAIRMAN SAMET: And they are 16 placed on this distribution. 17 DR. VEDAL: Right on the 18 distribution. 19 CHAIRMAN SAMET: Yes, yes. 20 DR. VEDAL: Right. 21 CHAIRMAN SAMET: So that's why I 22 think that is the right way to explain where202-234-4433 Neal R. Gross & Co., Inc. Page 38

1 the -- 2 DR. VEDAL: Yes. 3 CHAIRMAN SAMET: -- where they 4 sit, but I don't think demographics helps. 5 And, you know, I mean, I agree you are always 6 going to get down to say, "Well, gee, Tacoma 7 is funny" or "Baltimore is funny" or -- 8 MR. AVOL: So where are we going 9 to ask them to put that, again? 10 CHAIRMAN SAMET: Well, I think the 11 suggestion had been in chapter 6, but I think 12 both Helen and Ed have suggested that it would 13 also be and should probably be in chapter 4 as 14 well, which I think is -- 15 MR. AVOL: I mean, it seems like 16 they make the case in chapter 4 and describe 17 it. And chapter 6 is sort of an integration 18 of the whole summary. So I think it has got 19 to be in chapter 4 to set the premise for why 20 you're using it. 21 DR. STALLWORTH: So is there a 22 specific here for the letter? Page 39

1 CHAIRMAN SAMET: Well, I think 2 it's that it be included in both chapters 4 3 and 6 with more complete explanation in 4 chapter 4. 5 DR. HENDERSON: I think that would 6 be good. 7 DR. STALLWORTH: Okay. 8 CHAIRMAN SAMET: Okay. And then 9 we are going to make a small change in the 10 overall letter. 11 MR. AVOL: I think, Jon, though, 12 we do need to be a little careful about the 13 claim that it is representative of the 15. 14 CHAIRMAN SAMET: No, I don't think 15 we should claim representativeness. 16 MR. AVOL: Yes. 17 CHAIRMAN SAMET: The question is, 18 I don't think anyone is. 19 MR. AVOL: Well, right now in line 20 6 of Sverre's comments about the 21 representativeness of the 15 urban areas. 22 CHAIRMAN SAMET: Wait a minute. Page 40 1 Show me where. It would be helpful. That's 2 useful for understanding. I don't think he's 3 claiming representativeness. 4 MR. AVOL: I did. 5 CHAIRMAN SAMET: Sverre, we're 6 muttering about you over here. 7 DR. VEDAL: Oh, sorry. 8 CHAIRMAN SAMET: That's all right. 9 So your first long sentence, where you talk 10 about the representativeness, you're not 11 trying to imply that there is 12 representativeness. You're just -- 13 DR. VEDAL: No. That you assess 14 the representativeness. 15 CHAIRMAN SAMET: That you assess 16 the representativeness. 17 DR. VEDAL: I could clarify that, 18 but I thought that was the purpose of sort of 19 putting -- 20 CHAIRMAN SAMET: That was my 21 reading as well. Okay. So, just to revisit 22 this, then, this chapter 5 goes away, should Page 41 1 be moved to an appendix, to support a small 2 discussion where the 15 cities are discussed 3 in chapter 4 and also used in chapter 6 in the 4 integrated summary when it is a question of 5 where these 15 cities sit and the distribution 6 of population risk is addressed.
7 HIGHLIGHTS OF 8 URBAN-FOCUSED VISIBILITY ASSESSMENT 9 CHAIRMAN SAMET: Okay. And this, 10 we sort of have the piece that Frank and I 11 wrote, which can come here as sort of an 12 extension of the charge. 13 Okay. Then chapter charge 14 question 6 relating to chapter 6. 15 DR. SPEIZER: Can I comment here? 16 I misunderstood the instructions. And so what 17 you see here that is marked "Speizer," the 18 first part of which I thought was a composite 19 answer to the whole thing -- 20 DR. STALLWORTH: I'm sorry, Frank. 21 What I did was -- 22 DR. SPEIZER: All right. Tell me202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 what you did. 2 DR. STALLWORTH: I interrupted 3 you. I didn't know whether you wanted your 4 old answers included. So I just put them in 5 there for A through E. 6 DR. SPEIZER: Yes. I figured we 7 could always take them out. 8 DR. SPEIZER: Okay. Fair enough. 9 I didn't even look at those. I just sort of 10 wrote the first part and stopped because it -- 11 DR. STALLWORTH: I went back to 12 your comments and just popped them in there 13 because I figured we could change it or take 14 them out. 15 DR. SPEIZER: Okay. 16 DR. STALLWORTH: So the first 17 paragraph called "Speizer," that's the new one 18 I got last night. 19 CHAIRMAN SAMET: Right. So is 20 that the right one? 21 DR. STALLWORTH: He did not answer 22 A through E last night. Page 43

1 CHAIRMAN SAMET: I see. 2 DR. STALLWORTH: So these are 3 individual comments and -- 4 DR. SPEIZER: Yes. The first two 5 paragraphs are what I wrote last night. 6 CHAIRMAN SAMET: I am so confused. 7 DR. STALLWORTH: Okay. The first 8 two paragraphs are sort of the overview answer 9 to -- 10 CHAIRMAN SAMET: I see. Okay. 11 DR. STALLWORTH: -- charge 12 question 6. 13 CHAIRMAN SAMET: I see. Okay. 14 DR. STALLWORTH: The A through E 15 components are not something he sent me last 16 night -- 17 CHAIRMAN SAMET: So you printed 18 this out. Okay. 19 DR. STALLWORTH: -- something I 20 pulled from his individual comments. 21 CHAIRMAN SAMET: Okay. Okay. 22 DR. PHALEN: In the second Page 44 1 paragraph, the general agreement that the 2 current standards are not adequate bugs me a 3 little bit, as you all might guess. I think 4 maybe they are not adequate in all areas in 5 the United States, but I think they might be 6 adequate in some areas. 7 So I would like to see if the 8 Committee would agree to kind of soften that 9 a little bit. 10 DR. SPEIZER: Well, the problem is 11 we're dealing with national standards. We 12 can't regionalize the effects. 13 DR. SUH: Do we actually even talk 14 about it with the standards with -- 15 CHAIRMAN SAMET: Yes. That's the 16 same. I mean, this is not really -- 17 DR. SUH: I'm not sure we ever -- 18 DR. BRAIN: We are not compelled 19 to do that here. 20 CHAIRMAN SAMET: Yes. 21 DR. STALLWORTH: Talk about what, 22 Helen? Page 45

1 DR. SUH: Well, we didn't really 2 discuss what are the standards for -- 3 DR. VEDAL: We will get there in 4 policy.
5 CHAIRMAN SAMET: Yes. 6 DR. SUH: And then also, I guess, 7 the other thing is we did discuss the risks 8 but not really their magnitude or their levels 9 of comparison, their relative value of 10 comparisons. So I guess I'm not sure that -- 11 MR. POIROT: The second half of 12 that sentence is still relevant. 13 DR. VEDAL: Yes. So we can strike 14 the first half. 15 DR. SUH: Yes. 16 CHAIRMAN SAMET: I mean, the issue 17 is whether, at what levels of PM the risk 18 analysis points to disease burden; that is, 19 that is there and potentially avoidable. 20 That is really what this is about 21 and not -- so the discussion -- I mean, it 22 would be inappropriate, I think, in this sort202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 of point in the process to discuss adequacy of 2 standards. 3 DR. STALLWORTH: So you are going 4 to strike that? 5 CHAIRMAN SAMET: I think we'll 6 probably strike. Let's go back to the first 7 paragraph, though, first. We have high 8 praise. We have unanimously pleased. 9 DR. PHALEN: I don't think we took 10 a vote on it. I think everyone was pleased. 11 CHAIRMAN SAMET: Yes. 12 DR. PHALEN: Maybe you could take 13 out "unanimously" because we don't have 14 everybody here to take a vote. 15 CHAIRMAN SAMET: I think the panel 16 was pleased it indicates. That's fine. 17 Frank, the sentence, "However, the results 18 presented could be summarized more 19 effectively, and, rather than being presented, 20 details should have warranted a more 21 integrative discussion," do you think there is 22 too much detail in chapter 6? I'm not sure Page 47
1 there is. 2 DR. SPEIZER: I think there is. 3 CHAIRMAN SAMET: You do? 4 DR. SPEIZER: Yes. 5 DR. BRAIN: Is chapter 6 where we 6 also had the -- was the text talking about 100 7 percent reduction in risk? 8 CHAIRMAN SAMET: Yes. That was 9 one of them down to the lowest measured level. 10 DR. BRAIN: The assumptions need 11 to be very clear or that should be eliminated. 12 I am still uncomfortable -- 13 CHAIRMAN SAMET: Yes. There is 14 some of that. I mean, there is the second 15 paragraph. Much of it is about the issue that 16 we highlighted in one of the bullets in the 17 letter, this issue of how do you set how low 18 the risk analysis should be extended? And I 19 guess that represents the ultimate extension. 20 So in a sense, it's covered, but 21 we may want to suggest that -- 22 DR. BRAIN: I would like a more Page 48
1 direct statement because that conflicts with 2 the third line, "a no threshold linear 3 effect." So to the extent that's true, then 4 just dropping it down another -- 5 DR. SUH: But weren't you also 6 talking about -- when you talked about the 7 different approaches and then there's the 8 peakiness and then there was the 100 percent 9 reduction in certain cities? Isn't that the 10 chapter you're referring to? 11 DR. BRAIN: Yes. I mean, there is 12 the nice -- 13 DR. SUH: There are a couple of 14 tables that had 100 percent reduction in risk. 15 DR. BRAIN: Right. And I guess I 16 am uncomfortable with that because it seems -- 17 DR. HENDERSON: I think that the 18 bottom paragraph does a good job of describing 19 what we discussed as far as having criteria 20 for determining how low you go. I thought 21 this paragraph was well-written. 22 DR. STALLWORTH: Joe, did you have Page 49 1 an edit to propose where it says, "no 2 threshold linear effect"? 3 DR. BRAIN: No. I mean, I agree 4 with that. 5 DR. STALLWORTH: Okay. 6 DR. BRAIN: But if you buy into 7 that, then it seems to me a scenario that 8 eliminates risk completely. It's inconsistent 9 with that. 10 DR. SPEIZER: Yes. I tried to 11 modify that, by this last part of this 12 paragraph says, "Pick a criteria and use 13 that." 14 DR. VEDAL: Well, I don't 15 understand what you mean by the lowest levels 16 at which reported results are in the U.S. Is 17 that the lowest measured value of a 18 distribution in which a study was done? 19 DR. SPEIZER: Well, I guess it 20 would have to be a study done for it to have 21 a reported result. 22 DR. VEDAL: Yes. But what value202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 do you -- 2 CHAIRMAN SAMET: Well, Sverre, 3 that's this LML is the lowered measured level, 4 lowest measured level. 5 DR. VEDAL: Yes. But that's where 6 you put the standard. 7 CHAIRMAN SAMET: No, no, no, not 8 the standard, but that was used for the 9 extension of the risk analysis. 10 DR. VEDAL: Yes. 11 CHAIRMAN SAMET: I mean, that's 12 what we're talking about. This paragraph 13 should not have the word "standard" in it. 14 This is actually about how to do the risk 15 analysis. 16 DR. BRAIN: That's sort of my 17 point. The absence of data doesn't 18 necessarily equal the absence of an effect. 19 CHAIRMAN SAMET: Yes. But this is 20 how you develop the risk analysis tools that 21 will be used in the policy assessment. 22 DR. VEDAL: Yes, but that's what Page 51 1 these are, standards 25 and 10. 2 CHAIRMAN SAMET: No, no, no. 3 They're values that have been used in the risk 4 analysis. They're not standards. 5 DR. VEDAL: All right. Have it 6 your way. That's all right. 7 CHAIRMAN SAMET: I mean, I think 8 in terms of process, they should not be 9 designated as standards at this point. 10 DR. VEDAL: All right. All right. 11 Nevertheless, I mean, the issue -- 12 CHAIRMAN SAMET: They might become 13 standards. 14 DR. VEDAL: The issue is I'm not 15 sure this gives them the guidance that they 16 need. The lowest levels at which reported 17 results are in the U.S. -- 18 CHAIRMAN SAMET: Well, but this is 19 the same. This goes back to the bullet we 20 have in the overall letter, which was to say 21 -- and, remember, we ended the discussion 22 yesterday without doing anything more than Page 52 1 saying there needs to be something explicit. 2 It needs to be written. And uncertainty is 3 one basis for -- 4 DR. VEDAL: I'm not arguing that. 5 I think that's a very good point. I am just 6 saying that this does not provide them that 7 guidance. This is ambiguous. 8 Is this saying that we look at the 9 lowest value in this cohort study that has 10 been done and we choose that to do a risk 11 analysis on, like 4? 12 CHAIRMAN SAMET: No. A different 13 issue is -- well, first, this should be 14 consistent with what is in the cover letter. 15 DR. VEDAL: Yes. 16 CHAIRMAN SAMET: So that should 17 be. And what the cover letter is saying there 18 has to be an explicit statement. And the 19 basis for that statement should be clear. 20 One basis would be that at some 21 point uncertainty is judged to be too great to 22 further extend. Another might be that you Page 53 1 have gone outside a range of values at which 2 observations have been made of risk in 3 populations. And I think that is where Frank 4 was going here in suggesting some 5 alternatives. 6 We are not -- so I think we need 7 to align this with what is in the letter. I 8 mean, it's not unreasonable to list out some 9 of the possibilities for doing this. 10 DR. VEDAL: I like your MAP. 11 CHAIRMAN SAMET: So what are you 12 arguing? 13 DR. VEDAL: The specific 14 recommendation here, which doesn't provide 15 them the proper guidance, I don't know. How 16 do you -- 17 DR. SPEIZER: I think I provided 18 two alternatives. One is to put the lowest 19 study value as the value that you go down to. 20 The alternative was to pick one in which there 21 was more than one study and pick some fraction 22 of that to be the lowest value to go down to202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 to avoid the problem of the outlier study. 2 DR. LIPPMANN: Is this the right 3 place to put the words "margin of safety"? 4 DR. SPEIZER: Well, I put it in 5 quotes. I put it in quotes because I wanted 6 to suggest that whatever the lowest value of 7 multiple studies is, that they take some 8 fraction of that as the value to do the risk 9 assessment on. 10 You know, maybe that's the wrong 11 word to use there, but I put it in quotes 12 purposely because I didn't believe it was a 13 real margin of safety. 14 DR. LIPPMANN: Well, we heard some 15 sensitivity from Karen yesterday about 16 introducing those words at this point, not 17 that they don't come in at some other point. 18 DR. SPEIZER: Fair enough. 19 Another set of words that would imply the same 20 thing, that you could go below multiple 21 studies, would be fine. 22 CHAIRMAN SAMET: But, you know, Page 55 1 this speaks back to the issue that I raised. 2 I mean, in my mind, the risk analysis would be 3 a tool in which you explore burden of 4 attributable disease and how that burden could 5 be avoided at different levels. And then you 6 use that information in the policy analysis to 7 make judgments. 8 What is backwards here is that 9 already the idea that has come that what might 10 be standards is the basis for setting these 11 numerical boundaries in the risk analysis. 12 And I can understand why and how 13 that happened, but in terms of sort of 14 thinking about the process, what we would like 15 to do is do the risk analysis, look at the 16 burden of disease, avoidable different points, 17 look at these distributions, and then make 18 some judgments as to where standards would 19 fall. 20 And I think now this sort of trap 21 that has come up is so now the question is, 22 well, gee, we stopped the trouble. Well, if Page 56 1 we go down to lowest measured level, then we 2 can eliminate potentially that much more 3 attributable disease, which happens because 4 you have a linear no threshold model, which 5 has been assumed. And its validity is hard to 6 judge as one goes lower and lower. 7 So the question then is it might 8 be appropriate for us to point out that the 9 setting of these limits should be guided by 10 understanding of the science, how certain it 11 is, how low one can go, and not necessarily 12 where you think in a later document you are 13 going to propose alternative standards. 14 And I think to me suggesting how 15 this should be done we should do here. 16 DR. SUH: Jon, can I ask you a 17 question? So in the risk assessment itself, 18 it talks about these alternative standards. 19 CHAIRMAN SAMET: Right. 20 DR. SUH: So one of the things 21 maybe we might want to suggest based on your 22 comments, which made sense, is that theyPage 57

1 choose a different way of presenting those 2 scenarios in terms of -- 3 CHAIRMAN SAMET: Yes. They could 4 become alternative standards. 5 DR. SUH: Right, but that perhaps 6 we would want to suggest some overarching -- 7 perhaps maybe that is not how they are 8 presented in -- 9 CHAIRMAN SAMET: Right. I mean, 10 exposure scenarios. What we really want for 11 the risk analysis is the most valid model that 12 can be developed. And then it's used for 13 developing various scenarios for policy 14 purposes that then can become. Then those 15 scenarios drive the development of alternative 16 sets of standards. I mean, it -- 17 DR. SUH: I agree that the way it 18 is set up now that those are the ones we are 19 thinking about. Those words are in our head 20 about those are the possibilities. 21 CHAIRMAN SAMET: Right, right. 22 Right.202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 DR. SUH: And so perhaps that gets 2 into much more of an overarching comment about 3 how these different exposure, annual and 4 24-hour exposure, levels want to be thought 5 about, just as an introduction to it. 6 CHAIRMAN SAMET: So maybe, I mean, 7 if you thought about this -- and maybe we need 8 another bullet in the letter -- sequence from 9 going from a research workshop to ISA to risk 10 analysis to the policy assessment document at 11 the time you begin the risk analysis in a 12 sense, you might or might not know what the 13 alternative suites of standards are going to 14 be. Ideally you don't know because you, in 15 fact, are going to base them on the risk 16 analysis. 17 So, again, I think it might be 18 worth perhaps a more general comment to talk 19 about what we think about the overall flow, 20 whether it's here or somewhere else, but I 21 think it -- does what I am suggesting here 22 about sort of the ordering make sense to Page 59

1 everyone? 2 DR. VEDAL: Yes, it does. I think 3 that part of the confusion, at least for me, 4 here -- and it may not be confusing for others 5 is this issue of the distinction between these 6 -- I don't know what else to call them -- mock 7 standards that are used for the risk analysis 8 and the lowest measured level down to which 9 risk is estimated in this. 10 CHAIRMAN SAMET: Right. 11 DR. VEDAL: And they're different. 12 DR. LIPPMANN: They are two 13 different issues. 14 CHAIRMAN SAMET: Right, yes, yes. 15 DR. VEDAL: Those are different. 16 CHAIRMAN SAMET: Right. 17 DR. VEDAL: And what is being 18 talked about here are the mock standards, not 19 the lowest measured level to which risk is -- 20 CHAIRMAN SAMET: Right. And then 21 our discussion there yesterday led us there 22 when this question came up, Well, gee, whet Page 60 1 we've modeled. Remember, the table that led 2 us to this was the one with these additional 3 going down. 4 DR. VEDAL: Yes, but, I mean, 5 that's what gets me hung up. at least when we 6 start talking about to the lowest level of 7 which reported results are in the ISA, that to 8 me smacks of lowest measured level, not a mock 9 standard. 10 DR. HENDERSON: To me what Frank 11 has said is -- I mean, this is a big problem, 12 how you go down on -- how far down do you go 13 with a no threshold level. 14 I mean, to me what this says is 15 you take the lowest level at which any effect 16 has been observed and some fraction of it for 17 a margin of safety. 18 DR. VEDAL: But what is that level 19 in a study? I mean, I don't understand that. 20 The lowest level at which an effect has been 21 observed? I don't know how you even get that 22 number. Page 61

1 DR. HENDERSON: Well, if you can't 2 observe it -- 3 DR. SPEIZER: I guess I was 4 thinking more of the average reported level in 5 a study. 6 DR. HENDERSON: Yes, in a cohort. 7 DR. SPEIZER: In a cohort study or 8 in some kind of study -- 9 DR. HENDERSON: Yes. 10 DR. SPEIZER: -- not the ten 11 percent outlier of that study. 12 DR. VEDAL: All right. So you 13 pick some assessment of sort of the mean of 14 the distribution -- 15 DR. SPEIZER: Mean of the 16 distribution, yes. 17 DR. VEDAL: -- that's used for 18 calculating the annual average. 19 DR. SPEIZER: Right. That's what 20 I would use, -- 21 DR. VEDAL: Yes. 22 DR. SPEIZER: -- something like202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 that. And if that's comfortable for you -- I 2 mean, that's really what I meant. I may not 3 use the right words for that, but that's what 4 I meant. So if we can wordsmith that 5 properly, that would be okay. 6 Now, Rogene, I would not go with 7 the lowest level in a fraction of that because 8 that gets us down to zero, I'm afraid. 9 DR. HENDERSON: I was using your 10 second suggestion with -- 11 DR. SPEIZER: The second was a 12 multiple study. After there, I would say you 13 have to have more than one observation at the 14 lowest level, so whatever level it would be. 15 DR. HENDERSON: I said it too 16 briefly. I mean imprecisely. 17 DR. SPEIZER: There may be other 18 alternatives. 19 CHAIRMAN SAMET: Let's go back. I 20 think we should, one, escalate a bullet out of 21 this up to the cover letter. And I think it's 22 going to address the process question, which Page 63 1 is, is the risk analysis about alternative 2 "standards." 3 And maybe we won't engage our 4 colleagues behind us in this dialogue or is it 5 about having the most valid model possible in 6 which any number of population exposure 7 scenarios are explored. 8 And then the drawing out of 9 alternative standards takes place in the 10 policy assessment document. I mean, that to 11 me makes sense. 12 Please? Have a seat right at the 13 table. 14 DR. MARTIN: I'm sitting here 15 trying to put into context the nature of your 16 discussion with how we are thinking about it 17 and how it will be meaningful to us in moving 18 forward. I guess I would just make a couple 19 of observations. 20 We have if you go back to all the 21 staff papers that you all have seen over time 22 done risk assessments that focused on Page 64 1 characterizing risk remaining upon just 2 meeting current standards and upon just 3 meeting a series of alternative standards. 4 And that helped inform judgments 5 about if you believe the standard needs to be 6 revised, what alternative standard might be 7 appropriate to consider. 8 Clearly the risk assessment was 9 targeted on simulating risks remaining upon 10 just meeting a set of alternative standards 11 because that's what most directly helps inform 12 judgments about standards. And so, too, does 13 this risk assessment. 14 And so the question before us is 15 what set of alternative standards should we 16 use, should we simulate in the risk assessment 17 that will be informative? 18 Well, to simulate sets of 19 standards that are way outside the range that 20 we think are plausibly reasonable to consider 21 wouldn't be a useful exercise. 22 So we are, of course, trying to Page 65 1 target on simulating alternatives that are 2 within what we understand to be the general 3 range that we will be thinking about. 4 CHAIRMAN SAMET: Yes. I think you 5 came at this with pretty strong priors, which 6 is really my point. And then what I found 7 that we heard yesterday was some questioning 8 by your own staff of whether your priors were 9 the right ones or not and why not go lower. 10 DR. MARTIN: Well, but, of course, 11 you can see this is an evolving process, which 12 is one of the benefits of doing multiple 13 drafts of a document. 14 In order to do the risk 15 assessment, you have to be completely 16 definitively about what alternative sets of 17 standards you are assessing. You have to 18 specify those numbers. 19 And if upon seeing those results 20 we decide, as in this case we did, that it 21 would be more informative, additionally 22 informative, to look at other sets of202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 standards, then we proceed to do that. 2 CHAIRMAN SAMET: Right. Yes. 3 DR. MARTIN: We're not trying to 4 be all omniscient at the beginning. 5 CHAIRMAN SAMET: Well, yes. 6 DR. MARTIN: But you do have to 7 lay out some choices to proceed. 8 CHAIRMAN SAMET: Right. So I 9 think, in fact, maybe the problem was, to use 10 your words, that there was perhaps too much 11 all omniscience in this instance. And, rather 12 than using considerations other than what you 13 think the standards might be, the suite of 14 standards that might be proposed, you have 15 some other basis for making the determination 16 of what scenarios you are going to -- 17 DR. MARTIN: That's what we are 18 understanding -- 19 CHAIRMAN SAMET: Right. 20 DR. MARTIN: -- you are discussing
21 -- 22 CHAIRMAN SAMET: Right. Page 67

1 DR. MARTIN: -- and your advice 2 is. And I understand that. And that's -- 3 CHAIRMAN SAMET: Yes. And I think 4 our advice is that you have something beyond 5 here's at the moment we started the risk 6 analysis of what alterative suites of 7 standards might be considered out in the 8 future. I mean, I think that is perhaps too 9 much prejudging. 10 DR. MARTIN: Okay. And the other 11 observation I would like to make gets at that 12 point. And it gets at the process point you 13 were just making. The way the discussion 14 seems to be going is the implication is that 15 the risk assessment is a filter between the 16 ISA and the policy assessment. 17 And that is not at all the way our 18 process is defined in our minds. In our 19 minds, we have an ISA that evaluates the 20 science. We then take that science, and we do 21 two things with it. One thing is we say, 22 okay. If we believe there is sufficient Page 68 1 information, appropriate information to 2 conduct a quantitative risk assessment, we'll 3 draw from that science assessment document as 4 a basis for doing risk assessment. 5 In addition and as a separate 6 matter, we also look at the evidence in the 7 ISA directly and ask the question, even if we 8 were never to do a quantitative risk 9 assessment, what does that evidence tell us 10 about the adequacy of the current standard and 11 potential alternative standards? 12 So we are using two lines of 13 reasoning to get to the discussions that are 14 presented in the -- 15 CHAIRMAN SAMET: Yes. I think 16 that is clear. And I don't think I view the
17 -- 18 DR. MARTIN: Okay. It wasn't 19 clear to me that it was clear to everyone. 20 CHAIRMAN SAMET: No. I don't 21 think I view these as so linear. And I think 22 the way you have posed the questions in the Page 69 1 policy analysis makes clear that there's sort 2 of one box to another box to another box kind 3 of thing. 4 DR. MARTIN: Okay. 5 CHAIRMAN SAMET: But I do think in 6 terms of the discussion we're having at the 7 moment, what would be helpful, I think, is if 8 you were able to describe how you select the 9 exposure scenarios for the risk analysis in 10 some way that, yes, you would probably have to 11 be realistic. 12 It does reflect some of the 13 potential scenarios, but there ought to be 14 other reasons as well because I am going to 15 think you found yourself yesterday. Well, 16 this could go lower, and it could go lower. 17 Those scenarios might be useful. And those 18 scenarios might be useful. 19 DR. MARTIN: And clearly we're 20 understanding the advice you're grappling with 21 how to word as saying that we really should be 22 thinking about how to describe our selection202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 of an array of alternatives to look at in 2 terms of where we have confidence in the 3 evidence and where we lose confidence that the 4 evidence will provide credible estimates that 5 would meaningfully inform the process and to 6 characterize that and create criteria for 7 that. 8 DR. SPEIZER: I think we were 9 getting a little comfortable coming into the 10 meeting yesterday at 12. You added some 11 information to show some effect at 10. 12 The real question that comes up 13 is, why not seven and a half? So you need to 14 have criteria for stopping. I mean, that's -- 15 CHAIRMAN SAMET: Okay. Thank you. 16 So I think, just going back 17 through this, I think that we will write 18 something additional. And the overall letter 19 will align that with what is here. 20 Let's see. I'll just turn the 21 page. We are scheduled for our public 22 comments previously. And I wonder if we can Page 71 1 just try and finish this up in the next few 2 minutes. 3 DR. SPEIZER: Jon, I think it is 4 going to be hard because this really primarily 5 comments from me. And other people will want 6 to have some input into it. I would suggest 7 that we might give people a chance to read all 8 of this over and modify it. 9 CHAIRMAN SAMET: Okay. That's 10 fine. We were scheduled -- it's about now, I 11 think, Holly -- 12 DR. STALLWORTH: Yes. 13 CHAIRMAN SAMET: -- to do our 14 public comments on the visibility document. 15 And, if I understand, we have -- 16 DR. STALLWORTH: Dave Heinold, 17 American Petroleum Institute. Do we have your 18 handouts? 19 MR. HEINOLD: Yes. 20 DR. STALLWORTH: I've got so much 21 paper I don't know if I have it. 22 MR. HEINOLD: You should. Page 72 1 DR. STALLWORTH: Okay. Thank you. 2 CHAIRMAN SAMET: Thank you. I 3 think that's fine. Wherever you are most 4 comfortable, I think. And if you could limit 5 your comments to five minutes, please? 6 PUBLIC COMMENT ON UFVA 7 MR. HEINOLD: Okay. My name is 8 Dave Heinold. I'm with AECOM Technology 9 Corporation on behalf of American Petroleum 10 Institute. 11 Again I would like to pass on some 12 of our comments, interpretation regarding the 13 urban visibility issue and how it was reviewed 14 in second external review draft. 15 The main issue that I would like 16 to bring up is that urban visual air quality 17 has been characterized in the studies thus far 18 as being associated with extinction of either 19 550 nanometers or possibly related to PM2.5 20 concentrations. 21 And, again, I would like to 22 reiterate that what we know about urban Page 73

1 visibility is that is a lot more complicated 2 and varies from city to city. And the issues 3 are probably a lot more complex than has been 4 characterized. 5 Specifically I would like to point 6 out that extinction measurement at a single 7 location over a one-hour period doesn't 8 adequately characterize persons experienced in 9 urban visibility. And it depends on a lot of 10 other factors. 11 Among those factors are how far 12 you're looking; where your scenic vista is; 13 and, most importantly for urban visibility, 14 the contribution of nitrogen dioxide, not in 15 the extinction at 550 nanometers but the 16 effect of nitrogen dioxide and the 17 carbonaceous particulate in reformulating the 18 ratios of light that people see so that you 19 have discoloration resulting in that. 20 And while the studies identify, 21 talk about the relationship of NO2 to 22 extinction and correctly say that NO2 does not202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 contribute to extinction very much more than 2 like 5 percent, even in urban areas, it does 3 have a large effect on the discoloration. 4 And to pretend that it doesn't and 5 also pretend that all particles scatter light 6 in the same way, whether carbonaceous or 7 non-carbonaceous, that kind of does a 8 disservice to the whole science of urban 9 visibility. 10 Another issue is that the hourly 11 point extinction measurements are too variable 12 to properly characterize urban visibility 13 because it is a path-integrated effect. And 14 so that one needs to look at perhaps other 15 ways of characterizing visibility than have 16 thus far been reviewed. 17 Another shortcoming of the data 18 that we have thus far is that we have very 19 limited and, as acknowledged in the studies, 20 a very limited number of studies relating how 21 people perceive urban visibility and what 22 ranges of extinction specifically are Page 75

1 interpreted as being meaningful in terms of 2 their welfare. 3 The limitations of the studies are 4 well-discussed in the study, but what it 5 doesn't seem to point out is that there are 6 such profound differences, regional 7 differences, and differences of contribution 8 of different particulate types. That would 9 make it very difficult to hang your hat on a 10 single measure of visibility that is going to 11 adequately protect visibility in urban areas. 12 And because we found that there 13 are such large variabilities, it is going to 14 be difficult to establish a single standard 15 that is going to adequately protect all of the 16 areas, urban areas, of the country. 17 Another thing that has been 18 discussed and will be brought out in the 19 policy document is, well, can now we use 20 24-hour PM2.5 mass, which is already being 21 measured for health effects to also relate to 22 visibility issues? Page 76
1 And I think a discussion of all 2 these steps one needs to take to transform 3 PM2.5 mass, even just to extinction, 4 regardless of the other issues related to 5 urban visibility, it's a very tall task to do. 6 And there are many limitations in 7 doing so and a great deal of variation among 8 weather patterns in various cities and the 9 contribution of primary and secondary 10 particulates of various types that is going to 11 make it very difficult to relate particulate 12 mass, especially averaged over a period to 13 relate that directly to one's experience in 14 terms of visibility in urban areas. 15 Finally, to summarize the 16 comments, we feel that there are an 17 insufficient number of studies right now to 18 define what urban visibility impairment is and 19 that the measures for urban visibility that we 20 are considering are probably not going to be 21 adequate going forward in terms of actually 22 protecting visibility. And so that, indeed, Page 77 1 more study should be done and to evaluate 2 whether there really is a threshold of 3 extinction or other parameters that need to be 4 evaluated to protect urban visibility. 5 And the information thus far 6 presented does not provide a compelling case 7 in which to create an ambient air quality 8 standard. And that's a summary. 9 Thank you. 10 CHAIRMAN SAMET: Okay. Thank you. 11 Questions for Mr. Heinold? 12 DR. BRAIN: I have a question. 13 CHAIRMAN SAMET: Joe? 14 DR. BRAIN: Sure. It seems to me 15 you are better at pointing out the problems 16 than offering a solution. We care about 17 visual air quality. 18 MR. HEINOLD: Yes. 19 DR. BRAIN: PM2.5 isn't perfect. 20 MR. HEINOLD: Yes. Okay. 21 DR. BRAIN: It's not perfect for 22 health either. Is there another criterion202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 pollutant that is a better surrogate for the 2 VAQ? How -- 3 MR. HEINOLD: Well, my background 4 has been in plume visibility study, visible 5 plumes from power plants, et cetera, over the 6 years. And I think some of those techniques 7 need to be brought forward into looking at 8 this. 9 The way I see what has been 10 studied thus far has been based on what we 11 have learned about class one areas, where we 12 have a really good idea in class one areas 13 that extinction of 550 nanometers is a very 14 good indicator of the reduction in visual 15 range. In the urban settings, there are other 16 things involved. 17 So I would suggest if we are going 18 to do measurements, we need to take 19 measurements that account for the variability 20 of extinction over wavelengths, perhaps using 21 transmissometers or other techniques that 22 account for discoloration in addition to Page 79

1 extinction. 2 And so I don't think there is a 3 perfect answer, I think something that more 4 directly measures that people are seeing. And 5 some of the suggestions that you'll see here 6 are that it is only just a point source at a 7 single location that one distributes over an 8 urban setting and take averages, rather than 9 using a single location and things like that. 10 So I think there are a lot of 11 areas of refinement that could be pursued. 12 Thank you. 13 CHAIRMAN SAMET: Okay. Thank you. 14 Next commenter is Anne Smith. 15 DR. SMITH: I'm Anne Smith, 16 Charles River Associates. I'm speaking on 17 behalf of UARG today. I want to focus my 18 comments on the statistical basis and some 19 issues in the statistics underlying the 20 candidate protection level range of 20 to 30 21 deciviews that EPA is using in UFVA. 22 These are based on logistic curves Page 80 1 and statistically estimated recently and to 2 justify the candidate level range from 20 to 3 30. With 20, it comes from a Denver study. 4 The 30 comes from a, one, Washington, D.C. 5 analysis. 6 However, in the document, that 7 memo from Strauss Consulting that conveyed 8 these logistic recurrences to EPA, it reported 9 a number of other EPA findings that are being 10 ignored in UFVA but are relevant. 11 These are, in particular, that 12 there is strong heterogeneity across the 13 cities in the preferences, that the preference 14 malleability that was shown in Smith and 15 Howell is statistically significant, and that 16 there is a statistically significant estimate 17 above 30 deciviews that is relevant. 18 All of these undermine several 19 points that are being used in the UFVA, 20 undermines the ability to set a uniform 21 national standard, undermines the ability for 22 these kinds of preference studies to be used Page 81 1 for setting any VAQ standard at all, and 2 undermines the setting of the upper bound of 3 the standard protection levels at 30 4 deciviews. 5 On the first point on the 6 heterogeneity, Stratus concludes that the 7 results are heterogeneous across cities. They 8 say the hypothesis test of the means across 9 the cities, that is, are the same. It's 10 strongly rejected for all pairs of cities, 11 indicating that the mean 50 percent criteria 12 deciview levels differ for all 4 cities. 13 This heterogeneity undercuts the 14 support for setting a uniform national 15 visibility standard. For instance, instead of 16 being able to say we have a national 17 distribution with some uncertainty on what the 18 preference level is from which all of these 19 cities are randomly drawn sets, the Stratus 20 statistical results are saying that we have 21 statistically significant differences in the 22 acceptable VAQ level from city to city.202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 As you can see here, the 2 confidence intervals for each city do not 3 overlap at all. For those of you who prefer 4 to look at t statistics, this is taken 5 straight from the memo. 6 And what is most important to see 7 here is these are the t statistics supporting 8 the data on the previous slide. They're 9 extremely high, suggesting a very strong 10 rejection of the possibility that these are 11 random draws off of one uniform national 12 distribution. In fact, they are separate 13 distributions. They're not due to variants. 14 On the point about preference 15 malleability, Smith and Howell did three tests 16 all of the Washington, D.C., all of the same 17 Washington, D.C., vista. And it found that 18 the preference response that you get from 19 these surveys is very malleable. 20 What the Stratus survey does, 21 statistical analysis does, is show that these 22 test differences are not due to variance. Page 83 1 They are statistically significant. And this 2 means that these preference studies cannot be 3 used as a basis. They are not a robust 4 scientific basis for setting a preference 5 standard. 6 This is what Smith and Howell 7 said, but this is the Stratus results are 8 confirming that through their own independent 9 analysis. 10 Again on the left here, I am 11 showing the results that support this 12 statement. And I have drawn the confidence 13 intervals in that table for it to help on 14 visually seeing what is going on here. 15 The confidence intervals are the 16 three blue bars for test one, test two, and 17 test three on what their preference levels 18 were. These are the 95 percent confidence 19 intervals. 20 You can see they do not overlap. 21 They are very strongly different from each 22 other. And, importantly, you will notice test Page 84 1 three is statistically significant and well 2 above 30 deciviews. It has a deciview level 3 of a mean of 32.3. 4 So while we feel that these tests 5 really can't be used to set a standard, if EPA 6 is going to persist in using these preference 7 studies to set a standard, they need to at 8 least use the test three result for the range. 9 And that would bring the range up into well 10 above 30 to 32 or 33. 11 Test three from the D.C. study -- 12 and this is acknowledged in the UFVA -- did 13 encompass the most complete range of photos of 14 visibility conditions in Washington, D.C. So 15 it is actually the better of all the tests if 16 one has to choose one of those three tests to 17 pick a number for Washington, D.C. 18 Thank you. 19 CHAIRMAN SAMET: Okay. Thank you. 20 Are there questions for Dr. Smith? 21 (No response.) 22 CHAIRMAN SAMET: Okay. Thank you. Page 85 1 So thank you to our two commenters. 2 At this point we I think should 3 probably return to where we were. We will 4 come back to our visibility discussion, 5 hopefully joined by Tom and having heard the 6 public comments, and continue our work on that 7 document. 8 So I think what I would suggest is 9 that we go back to where we were when Frank 10 suggested we need a little more time because 11 the group has not had a chance to interact 12 around developing the specific responses to 13 the A, B, C components or whatever of question 14 6. 15 So we had that general discussion 16 about question 6. Now if we could go on, 17 then, to A. And we can see both, Frank, how 18 you feel about what you wrote before the 19 meeting and whether others want to chime in. 20 And we can at least perhaps make sure the 21 general points are there absent sort of 22 wordsmithing these responses.202-234-4433 Neal R. Gross & Co., Inc. Page 86
1 So A is to what extent does the 2 panel believe that we have captured the key 3 policy-relevant questions that can be 4 addressed by this risk assessment. 5 DR. VEDAL: Just to clarify the 6 first sentence after "questions" on the 7 beginning of line 2, which would be 4 PM2.5, 8 then it goes on to say it doesn't do a trip 9 and other particles. 10 DR. SPEIZER: Yes. Now, you know, 11 I think we've got now a brief review of the 12 policy assessment, which is a chapter on 10 13 minus 2.5 although it needs to be fleshed out, 14 I think, considerably. 15 I actually put this in sort of 16 hopefully if it was necessary to push, that 17 the PA would have something in it. So given 18 that that has occurred, I am not sure that we 19 need to have it in here. How other people 20 feel about it I don't know. 21 DR. LIPPMANN: I see nothing wrong 22 with indicating the scientific concern that's Page 87 1 adequate, commendable even, for PM2.5. It 2 overlooks an important area of public health 3 concern. 4 DR. SPEIZER: Okay. We can leave 5 it in. 6 CHAIRMAN SAMET: I think that's 7 fine. So, I mean, certainly doing a risk 8 assessment for PM10-2.5 or coarse mass PM 9 would have been useful for policy purposes. 10 It simply was not here. 11 So I think if you want to offer 12 the reminder that it wasn't done, which I 13 think is what Mort said, that I think we could 14 reduce the text here otherwise. 15 DR. LIPPMANN: Yes. And maybe the 16 last sentence is necessary. 17 CHAIRMAN SAMET: I think there 18 could be two sentences here to get a sense of 19 that. So it would be one says good job, and 20 the next one says but. 21 Okay. B. 22 DR. VEDAL: Regarding A again, I Page 88 1 mean, so this is only relevant to the coarse. 2 I missed the discussion as to whether there's 3 a thing about these other less than other 4 causal things is also relevant to fine PM, 5 right? 6 DR. SPEIZER: Yes. I don't 7 remember whether I put that in specifically. 8 Again, that does come out in the PA. There 9 was a place I did write something about those 10 other factors. 11 CHAIRMAN SAMET: You know, 12 actually, Sverre, just to challenge you, the 13 word is key, policy-relevant. And I think if 14 you are proposing that a quantitative risk 15 assessment should have been done for some of 16 these other -- 17 DR. VEDAL: No, I'm not proposing 18 that, no. I'm saying I think this is just 19 saying there is some parenthetical stuff here 20 that's saying we're -- 21 CHAIRMAN SAMET: But this refers 22 to this risk assessment. I mean, I think in Page 89

1 a sense -- 2 DR. VEDAL: Yes. This is a risk 3 assessment for fine PM, right? 4 CHAIRMAN SAMET: So what is your 5 point? I mean, I think the point is that if 6 you think that the risk assessment should have 7 been done for these other health outcomes, 8 then we should say that. I don't personally 9 think that we should. So I'm not sure what 10 you would want to mention here. 11 DR. BRAIN: We just want them to 12 be mentioned to be acknowledged as emerging 13 concerns. 14 CHAIRMAN SAMET: Well, we've done 15 that. We've done that in our prior -- 16 DR. BRAIN: Actually, it's in this 17 sentence here. 18 CHAIRMAN SAMET: We actually did. 19 We made a fairly strong point of that in our 20 prior comments that we, in fact, said 21 something like there may be health outcomes. 22 So the level of causal, of202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 strength of causal inference has not reached 2 that of likely causal or causal but which may 3 be of such importance for public health and 4 risk assessment. We have already said that. 5 DR. VEDAL: What I'm saying is 6 this seems to be a confusing point about 7 coarse and a point about these other issues. 8 DR. SPEIZER: Yes, yes. You're 9 right. I mean, it's in here. That really 10 applies to fine. And so maybe a modifier of 11 that second sentence. 12 CHAIRMAN SAMET: I think we have 13 actually made the point already about -- that 14 was very clear in our prior letter. 15 DR. VEDAL: I would be happy not 16 saying anything. 17 CHAIRMAN SAMET: Okay. And we 18 made the point about coarse mass PM before. 19 DR. SPEIZER: I mean, I think 20 Sverre is saying that this looks like I'm 21 worried about the suggested health findings as 22 applied to coarse. And they really apply to Page 91 1 fine. So you might need to have another 2 qualifier in that sentence or to both, yes, or 3 to both. 4 DR. STALLWORTH: Okay. I made 5 note of that. We can wordsmith. 6 DR. SPEIZER: It's just wordsmith 7 that. 8 CHAIRMAN SAMET: Okay. So on to 9 B, which is actually one of those pretty long 10 questions. 11 DR. SPEIZER: Yes. I'm afraid 12 here I was confused as to how the national -- 13 well, first, I was confused on two scores. 14 One, understanding the peakiness of the peak 15 shaving issue and how -- I didn't understand 16 the shift. I think I've been dealt with, how 17 it shifts the whole distribution. 18 And then, secondly, I somehow 19 combined how the 15 sites played a role in the 20 national estimates. 21 So I don't know that anything I 22 have said here makes a lot of sense. So we Page 92 1 need some new words, I think. 2 CHAIRMAN SAMET: Total 3 wordsmithing. 4 DR. SPEIZER: And if I look at 5 what Sverre said, I think he said yes. 6 DR. VEDAL: Yes. There's nothing 7 else. 8 DR. STALLWORTH: Rich, do you want 9 to call Tom Moore? I've e-mailed him twice 10 this morning. 11 CHAIRMAN SAMET: So section 6.2, 12 just to remind everybody, is called 13 Interpretation of Urban Study Area Results. 14 And so this is sort of about the heart of the 15 analysis in going through just meeting these 16 alternative standards and so on. 17 So there's a lot of detail here. 18 And the question is, so to what extent do the 19 panel members believe that the observations 20 presented in section 6.2 are well-supported by 21 the results of the analysis? I mean, what 22 they have done, what is done here is a lot of Page 93 1 the analysis from chapter 4 is brought 2 forward. 3 DR. SPEIZER: Is brought forward. 4 And I think it probably was fine. 5 CHAIRMAN SAMET: So the question 6 is, how well were things brought forward? 7 That's one thing. I mean, I guess the 8 question in the end is, how well does 6.2 do 9 its job of summarizing key points out of 10 chapter 4? 11 DR. SUH: Can I ask, isn't this 12 the section that we had a lot of problems 13 about the risk reductions and what that means? 14 And so in response to this part of that, the 15 charge, are we supposed to just reference back 16 to chapter 4 in those questions we have on 17 those comments or -- 18 CHAIRMAN SAMET: You mean those 19 questions, those issues we have just gone 20 through? 21 DR. SUH: Yes. 22 CHAIRMAN SAMET: I think those are202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 going to be in the sort of general piece that 2 would be written response to question 6 that 3 Frank has. So I think that is covered. 4 DR. VEDAL: That is the main 5 issue, yes. 6 DR. SUH: Well, I guess I am 7 wondering if we should just reference, just 8 say, you know, "As we discussed earlier" or 9 something like that. 10 CHAIRMAN SAMET: I mean, reduced 11 to a literal read of this question, it says 12 how well does section 6.2 do at representing 13 stuff that came before. And a simple answer 14 is it's okay. I mean -- 15 DR. SUH: That's not maybe the 16 most useful answer. 17 DR. VEDAL: Well, yes, but, I 18 mean, it is basically referring to the 19 discussion of chapter 4, then, that we -- 20 CHAIRMAN SAMET: Which we have 21 gone over. I mean, in a sense in chapter 6, 22 we should not be bringing up new conceptual Page 95 1 issues because it's an integrative summary of 2 what came before it. 3 DR. SUH: I agree. I totally 4 agree with that. I'm just wondering if we 5 should just say, notwithstanding the issues 6 that have been discussed before, this summary 7 presents -- whatever is fine. 8 MR. AVOL: Well, but it wasn't 9 fine because we gave them a clear indication 10 of chapter 6, that chapter 6 needed to be 11 clarified. 12 DR. SUH: That's the problem. In 13 some ways a response like a "Yes" would be 14 irrelevant because if you're suggesting they 15 change it a lot, then it doesn't really matter 16 what we thought the summary that they did -- 17 DR. SPEIZER: I hate to bring up 18 something that might cause a long discussion, 19 but I am going to do it anyway. I don't know 20 how easy it is for people to get to the 21 appendices, but there is a series of tables, 22 E-24 to E-34, which show the percent Page 96
1 reductions at the various scenarios that are 2 looked at. 3 I actually struggled with those 4 tables because the first column in the tables, 5 first column in the tables, is generally 6 recent PM concentrations. The second column 7 is the 15, 35 and then the various 8 alternatives. 9 Now, the minus numbers -- and 10 these are generally in the recent PM 11 concentrations, they pick a year -- are 12 generally minus numbers, which I interpret -- 13 maybe Zach can help us here -- as meaning that 14 if you like those standards, you would have an 15 excess risk compared to the others, which are 16 positive numbers, which would be a reduction 17 in risk. Am I wrong? 18 DR. PEKAR: So basically on those 19 tables, what they are doing is they are 20 comparing risk relative to the current 21 standard. So it's saying let's take current 22 standard as sort of the level, and underPage 97

1 recent conditions, most places have higher 2 risk. 3 Now, it's risk reduction relative 4 to the current standards. Let me stop for a 5 second and say if we look at the alternate 6 standard levels, we have a positive reduction 7 in risk. 8 Sort of the corollary of that is 9 then if under recent conditions you have 10 higher risk, in terms of a risk reduction, 11 that is actually negative because you can 12 either do it the other way -- we could have 13 said that, which might have been more 14 intuitive, under recent conditions, it is 15 positive. It is a higher risk. And then you 16 have percent reduction. It could have been a 17 negative. 18 DR. SPEIZER: But all of these 19 reductions are back to LML. Is that correct? 20 DR. PEKAR: All of those are 21 modeled. Well, the risk is estimated down to 22 LML.202-234-4433 Neal R. Gross & Co., Inc. Page 98

1 DR. SPEIZER: Yes. 2 DR. PEKAR: But, just to be clear, 3 those percent reductions are often dealing 4 with PM levels. You know, you're talking 5 about incremental reductions from 15 down to 6 14 down to 13 down to 12. The absolute risk 7 numbers are modeled down to LML. 8 DR. SPEIZER: That's where I have 9 a problem, is that -- and this is where Joe 10 has a problem in the sense that this is where 11 you get these 100 percent reductions. 12 DR. PEKAR: Right. 13 DR. SPEIZER: Would it not be 14 better that these were modeled to the delta 15 from the current standard, rather than down to 16 LML, just to give a more realistic estimate of 17 what the effects would be? That's the concern 18 I have about how that's done. I'm sorry. 19 CHAIRMAN SAMET: No. But isn't 20 this the point we have been discussing 21 generally, which is how are you going to say 22 where you're going, how well you're going to Page 99 1 go? I mean, I think this is the same general 2 point we have been speaking to but now in 3 particular. 4 DR. PEKAR: There are different 5 risk metrics that can be done. We can 6 certainly talk about the reduction, the 7 reduction in the percent of mortality 8 attributable to PM2.5. 9 And in that case, you're talking 10 about the degree of step-down in going from 15 11 to 14 to 13 to 12. And you don't have to 12 worry about how far down you're modeling 13 because you're only looking at the incremental 14 change. That is certainly one of the risk 15 metrics that we talk about in there. 16 But this particular one depending 17 on the risk metrics, some of them are very 18 responsive to the lower bound of the risk 19 estimation. Some of them only deal with the 20 incremental step-down. 21 And if there is a sense that the 22 risk metrics that deal with the incremental Page 100
1 reduction in a sense are better because we 2 have better confidence in that statement, I 3 think we even say that in the document, to the 4 benefit of the incremental risk reduction is 5 you're only talking about the magnitude of 6 risk associated with sort of stepping down 7 from 15 to 14 to 13 to 12. And you're not 8 focusing on how far down you have to go. 9 I'm not sure if that's clarifying. 10 DR. SPEIZER: So it seems to be 11 more intuitive to me -- 12 DR. PEKAR: Right. 13 DR. SPEIZER: -- to discuss it 14 that way than to take it down to 5.8. 15 CHAIRMAN SAMET: But I think this 16 is the same general discussion we have been 17 having. And maybe this goes back to whether 18 those tables stay in or go. If you can 19 specify something, I mean, I think, as you 20 said, it is very reasonable to go down 21 15-14-13, et cetera -- you happened to go 22 15-12, whatever. Page 101

1 But the question of how low you 2 go, as we have said, should be based on some 3 specified criteria. And I think, Frank, this 4 is for EPA to make a clear specification. 5 DR. SPEIZER: At this stage I 6 think we just need to say something about 7 that. 8 CHAIRMAN SAMET: No. We will. I 9 think we -- 10 DR. PEKAR: The absolute risk in 11 terms of how far down you go and then the 12 second issue that certain risk metrics don't 13 depend on that and really focus on the 14 incremental change -- and we may feel that we 15 have greater confidence -- and we do -- in 16 making those statements. And maybe those risk 17 metrics should be emphasized from a policy 18 standpoint. 19 I think we agree. And we could 20 strengthen that point. 21 CHAIRMAN SAMET: So let's go back. 22 We're somewhere at 6B. Let's see. Who else202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 was on this? Let me pull this out. So other 2 6B discussants were Sverre, Joe, Mort, and 3 Rogene. 4 DR. VEDAL: Yes. My observations 5 were well-supported, no other observations are 6 apparent was my contribution. 7 CHAIRMAN SAMET: Okay. So maybe 8 if the literal answer is has chapter 4 been 9 dealt with appropriately in chapter 6, the 10 easy thing is to say yes. But there are a 11 bunch of more difficult general issues around 12 chapter 4-6 that we have dealt with in 13 general. And I think Frank just came back to 14 it again. 15 DR. SPEIZER: Okay. 16 CHAIRMAN SAMET: All right. So 6B 17 is okay. 18 DR. BRAIN: But it's a good chance 19 to underline our concerns. 20 CHAIRMAN SAMET: All right. And 21 then 6C. This has to do with the descriptors 22 of levels of confidence and so on. I think Page 103 1 Frank is saying this looks also -- 2 DR. VEDAL: At this point I would 3 interject this observation on ischemic heart 4 disease. 5 CHAIRMAN SAMET: Yes. The IHD CBD 6 thing. Okay.
7 DR. VEDAL: Yes. 8 DR. STALLWORTH: Should we add a 9 sentence about that? 10 DR. VEDAL: I would like to, 11 although, again -- 12 CHAIRMAN SAMET: The point should 13 be made somewhere, I think. 14 DR. VEDAL: Yes, for sure. 15 DR. SPEIZER: I think that's good. 16 DR. STALLWORTH: I'll make a note 17 of it. 18 DR. VEDAL: I think it was brought 19 up. Someone brought it up earlier today, 20 actually, in the actual -- it may be 21 repetitious. Anyway -- 22 DR. STALLWORTH: We'll figure it Page 104

1 out. 2 CHAIRMAN SAMET: Okay. And then 3 D. 4 DR. SUH: Is this where you want 5 to put the comment in about the table -- 6 CHAIRMAN SAMET: Table 5.4. 7 DR. SPEIZER: 5.4. And maybe even 8 here this little discussion that we just had 9 about perhaps focusing more on the deltas 10 across the range, rather than down to a lowest 11 measured level. 12 DR. VEDAL: Yes. I mean, I think 13 the two are complementary. I mean, I think 14 down to the lowest measured level gives you 15 some notion of absolute risk and what's 16 remaining and the impact. The others, this 17 relative measure, it doesn't really give you 18 the full picture. Even though you're more 19 confident, it doesn't give you the full 20 picture, really. 21 DR. SPEIZER: Well, but it also is 22 I think more realistic as to what can be Page 105 1 anticipated to be expected to be accomplished. 2 I mean, I am concerned. 3 I guess, if you go down to the 4 lowest measured level, you are going to see 5 headlines in half the newspapers in the United 6 States anyway that say the EPA is not setting 7 the standard sufficient to protect the public. 8 And that's just not appropriate. 9 DR. VEDAL: Yes. I see that. 10 DR. LIPPMANN: Well, assuming that 11 there will be some tightening of the standard, 12 the lowest measured level would be a moving 13 target because there will be some efforts to 14 comply with the reduced standards. And then 15 the lowest measured level next round will be 16 25-30 percent lower than it is now. 17 So it's a poor frame of reference 18 to use lowest measured level. It depends on 19 how many epi studies they are and what the 20 ranges will be. 21 DR. VEDAL: It won't depend on the 22 standards.202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 DR. SPEIZER: We're talking about 2 economics. 3 DR. LIPPMANN: We're talking about 4 risk, not the standard here. And if the risks 5 are above and below our lowest measured level, 6 then the risks will shift and be hard to 7 explain. 8 CHAIRMAN SAMET: Okay. So I think 9 that looking at 6D-E, again, this relates to 10 some of the process stuff around the summary 11 and other issues. 12 DR. LIPPMANN: 6D? 13 CHAIRMAN SAMET: Well, 6D I think 14 we had just passed through. I've gone to 6E. 15 DR. LIPPMANN: E. 16 CHAIRMAN SAMET: This is that long 17 list of items at the end of the chapter. 18 DR. STALLWORTH: D or E? 19 CHAIRMAN SAMET: E. 20 DR. SPEIZER: Yes. I think this, 21 the long response, has kind of a little 22 politics in it that should probably come out. Page 107 1 DR. VEDAL: I mean, the issue here 2 is whether or not it's basic -- 3 CHAIRMAN SAMET: Yes, yes. 4 DR. VEDAL: They pretty much are. 5 CHAIRMAN SAMET: They pretty much 6 are. I mean, this is -- 7 DR. VEDAL: Again, that issue is 8 about the 12, the lower limit of the risk 9 assessment. That's all -- 10 CHAIRMAN SAMET: Which we have 11 addressed. 12 DR. LIPPMANN: This needs to be 13 revised. And I'm not sure it makes sense to 14 talk about the risk estimates from 2006 15 because the document goes into the better 16 database that we have now and supersedes what 17 the database was in 2006. 18 CHAIRMAN SAMET: I mean, again, 19 taking this straightforward, this one says, 20 "Have we listed the right stuff in the 21 bullets?" 22 DR. LIPPMANN: Yes. Page 108 1 CHAIRMAN SAMET: Yes. Okay. So 2 there's work to be done. I think we've gotten 3 the general shaping of it. And probably the 4 comments on chapter 6 are the most, 5 potentially the most, demanding. Let me make 6 a suggestion that if we want a short break, 7 now would probably be the right time to -- 8 DR. STALLWORTH: Let me ask, do we 9 have anybody on the line yet? Tom Moore? 10 (No response.) 11 DR. STALLWORTH: Okay. 12 CHAIRMAN SAMET: Okay. And then 13 we come back and look at the visibility 14 letter. Okay. Good. So let's reconvene by 15 10:00, which gives a generous 12-minute break. 16 (Whereupon, the foregoing matter 17 went off the record at 9:48 a.m. and resumed 18 at 9:59 a.m.) 19 CHAIRMAN SAMET: So everybody has 20 the visibility letter in front of you. And 21 thanks to the visibility team for working on 22 this. Page 109

1 DR. LIPPMANN: Yes. Thank you. 2 MR. POIROT: Well, so those first 3 three paragraphs were sort of intended to go 4 in the summary letter. And I wrote them kind 5 of blandly. 6 I think we really liked the first 7 urban visibility, urban focus visibility 8 assessment. We asked for a number of things. 9 And they delivered all of them in the second 10 draft. 11 So generally we were supportive of 12 it, had some relatively minor recommendations 13 in several sections and no major 14 recommendations. So that was intended just to 15 those first three paragraphs. 16 CHAIRMAN SAMET: And, actually, 17 Rich, maybe this would be the place. There's 18 one comment. We did think that there should 19 be a summary chapter to the document. And 20 that should go somewhere. 21 In fact, in the text that I had 22 written that Holly could maybe find again, I202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 had written something about the need for 2 either an executive summary or a sort of 3 integrative chapter at the end. 4 So, Holly, you could just put that 5 text in. 6 MR. POIROT: Good point.
7 DR. STALLWORTH: So Jon's 8 paragraph is "With regard to the visibility 9 assessment, CASAC welcomed the additional 10 analyses of the urban visibility preference 11 studies. This unified analysis provided 12 useful insights into the variation and 13 visibility preferences among the study panels. 14 This completed analysis should now be folded 15 into the document. 16 "CASAC also recommends the 17 addition of an integrated summary chapter. At 18 present, it lacks a summary that brings main 19 findings and their implications together. The 20 chapter might be included in the summary as a 21 first chapter or at its conclusion. 22 "There is also a need for further Page 111 1 research on the topics related to visibility 2 need to be assembled in" -- 3 CHAIRMAN SAMET: Yes. I said 4 there might be a compilation of research needs 5 in this, so the mention of that, too. Those 6 are -- 7 MR. POIROT: Yes. 8 CHAIRMAN SAMET: So we'll put that 9 in. 10 MR. POIROT: Yes. I like that 11 better than mine. 12 DR. STALLWORTH: Do we have anyone 13 on the line? 14 (No response.) 15 CHAIRMAN SAMET: Okay. So that 16 would be sort of the draft cover letter, the 17 main points. And then the charge questions, 18 should we go there? 19 MR. POIROT: I guess Lowell had 20 the first one. 21 CHARGE QUESTION #1 22 DR. ASHBAUGH: Yes. I think Page 112 1 there's too much in here. I put in a lot that 2 I had in mind. 3 DR. STALLWORTH: We need to export 4 some of the minor comments, too. 5 DR. ASHBAUGH: Yes. I think those 6 should remain, perhaps with some changes. 7 Practically everything else can be moved. I 8 don't know if there's anything there that 9 needs to be kept in response to the charge 10 question. 11 DR. STALLWORTH: I didn't know. 12 And the reason I didn't remove it myself is I 13 didn't know whether this comment about sea 14 salt we wanted to leave. 15 DR. ASHBAUGH: Yes. Well, yes. I 16 do have that in my individual comments, but I 17 wasn't -- I am not sure that the panel wants 18 to have it in in the panel comments or not. 19 So that's up to the panel. 20 DR. GRANTZ: I think it ought to 21 remain in the general comments because I think 22 it is an important point. Page 113

1 MR. POIROT: I guess I will take 2 the other view. Especially in the context of 3 this assessment and in the specific urban 4 areas used, I'm not sure I see it making it a 5 big difference -- 6 DR. GRANTZ: That's true. 7 MR. POIROT: -- in this 8 assessment. Maybe if we don't look, we don't 9 -- I think let's leave it in. I think it 10 doesn't hurt anything. 11 DR. STALLWORTH: And extract all 12 of the other paragraphs. 13 MR. POIROT: I don't want to be 14 telling them they need to redo the whole 15 assessment to have sea salt. They might 16 mention it at some point, finding out that it 17 could be a contributor in some of the near 18 coastal areas. 19 DR. ASHBAUGH: I can work with you 20 on a revision of that. 21 DR. STALLWORTH: Okay. I'm going 22 to go ahead and delete all but the first --202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 what was it -- three paragraphs and the sea 2 salt. 3 DR. ASHBAUGH: The first two -- 4 DR. STALLWORTH: First two. 5 DR. ASHBAUGH: -- and the sea 6 salt. 7 DR. STALLWORTH: Okay. And then 8 you can -- 9 DR. ASHBAUGH: I think a lot of 10 this actually stays on the definition of 11 haziness, the last paragraph on that page. 12 Did you want that in the comments? 13 DR. GRANTZ: I think that is 14 something, too, that they might look at. I 15 don't think it needs to be in this letter. 16 DR. ASHBAUGH: Okay. So we can 17 just leave it back in your individual 18 comments. 19 DR. GRANTZ: Yes. I think we can 20 take that out here. 21 DR. ASHBAUGH: Yes. Okay. 22 DR. STALLWORTH: Okay. Page 115

1 CHAIRMAN SAMET: So on to question 2 2? 3 DR. STALLWORTH: Yes. 4 CHAIRMAN SAMET: Question 2. This 5 is Chris. Actually, why don't we go to 6 question 3. Hopefully Chris may be here soon, 7 and, Rich, we're going to run out of time on 8 -- 9 DR. STALLWORTH: Do we have 10 someone on the line? 11 (No response.) 12 CHARGE QUESTION #3 13 MR. POIROT: So question 3 was 14 asking about our take on the newly added 15 discussion of the 90 percent RH screen and its 16 specific application in removing influences of 17 natural weather, removing periods where 18 natural weather was likely to be an overriding 19 influence on visibility, rather than air 20 pollution. 21 I think we generally found it to 22 be a fairly well-presented analysis, Page 116 1 especially as modified by the memo that we 2 only discovered yesterday that actually made 3 some of the statements that weren't correct, 4 made them correct. 5 I wanted to also add the 6 additional comment that this use of a 90 7 percent RH screen would also for other reasons 8 be beneficial in characterizing the secondary 9 standard itself. 10 That is, it's one question to use 11 it in the risk assessment, but there are other 12 good reasons, some of which Ted alluded to 13 that came out of the discussions from the 14 Monitoring Subcommittee for using it as a 15 filter in making measurements as well. So 16 that was the tone of the second. 17 CHAIRMAN SAMET: Okay. Other 18 comments? Everybody is okay? It's to the 19 point and focused? 20 (No response.) 21 CHAIRMAN SAMET: Sverre, any 22 comments on -- Page 117

1 DR. VEDAL: Silence. 2 CHAIRMAN SAMET: Okay. So 3 question 4. Again, Rich, this is you. 4 CHARGE QUESTION #4 5 MR. POIROT: This question was 6 asking about our take on the, largely, I 7 think, on the, graphic presentations and some 8 of the tabular information that was presenting 9 some of the requested alternative analyses and 10 so forth that we were asking for; for example, 11 the influence of this RH screen, looking at 12 other percentiles, including the 98th 13 percentile, and so forth and the comparisons 14 between using the single worst hour of the day 15 and then calculating percentile versus 16 calculating the percentile across all the 17 daylight hours. 18 So, again, I think generally we 19 found these graphic presentations to be very 20 useful and informative. I think everybody who 21 commented especially liked the tile plots. 22 There's a lot of information there that's202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 really nicely summarized. 2 I thought we did have an issue 3 with the sort of apples versus apples 4 comparability of selecting the single worst 5 hour versus using all of the hours and that we 6 would like to see a more direct sort of a 7 one-to-one kind of a comparison. 8 I don't push any specificity in 9 there, largely because I felt like the staff 10 was sort of nodding its head as if it had good 11 ideas of how to address that. And I thought 12 it was maybe better to not be too specific of 13 exactly how to do that. So I didn't put any 14 specificity in here. 15 We could think about, talk about 16 adding that, that it would be probably a 17 detailed discussion and emphasizing that that 18 choice of whether to do it one way or the 19 other might actually be very important. Maybe 20 it isn't. We just don't know because we can't 21 see it. 22 So let's take a close look at Page 119 1 that, see what kinds of different maybe 2 species or sources or neurological conditions 3 or whatever come into play and get emphasized 4 by using one approach versus the other 5 approach. 6 And then the last point was 7 emphasizing the comments that some of us had 8 on apparently illogically high it seemed 9 contributions of the coarse mass in some cases 10 that, again, nobody is saying we do all of 11 this but, rather, just put a pointer to this 12 in the text that encourages some caution 13 interpreting some of those results. 14 CHAIRMAN SAMET: Okay. Any 15 additions to this, Lowell? 16 (No response.) 17 CHAIRMAN SAMET: So you're 18 comfortable with this. Okay. Good. So that 19 leaves us, I guess, with the piece from Chris. 20 And we do expect him -- 21 DR. STALLWORTH: He said 10:30. 22 Probably -- Page 120 1 CHAIRMAN SAMET: 10:30. So maybe 2 we can hang on. Anything else on visibility? 3 I know you are going off soon, Rich. So -- 4 MR. POIROT: So what were we going 5 to do about question 2? 6 CHAIRMAN SAMET: Well, we can 7 either go through it or we can wait until 8 Chris comes in or do both. 9 CHARGE QUESTION #2 10 CHAIRMAN SAMET: Do you have 11 comments to the response as it is written now? 12 MR. POIROT: My tendency would be 13 to defer to Chris' opinion on the topic. I 14 thought he did a good job explaining yesterday 15 and so forth. 16 DR. STALLWORTH: He had comments 17 on the budget analysis, which I just stuck in 18 there. And this will have to be smoothed out. 19 MR. POIROT: I think looking at 20 the whole of the comments put all together, 21 it's probably more detailed than we want. I 22 wonder, though. David really had some Page 121

1 concerns. 2 DR. GRANTZ: Yes. I would like to 3 address the middle paragraph on page 4. While 4 I strongly support the use of logit and I 5 think that takes those data just about as far 6 as they can go, the data remain quite limited. 7 And I think this letter should 8 reflect the fact -- well, reflect an opinion 9 of mine anyway that we may really not be 10 looking at data that have a central tendency, 11 that these may be real regional differences 12 which will be borne out by future research. 13 DR. STALLWORTH: So you would 14 soften the sentence that says, "The overall" 15 -- 16 DR. GRANTZ: I would add in it an 17 explicit sentence that says that not only is 18 further research to be recommended but that it 19 is reasonable, a reasonable interpretation of 20 the available data is that there are regional 21 differences. I don't know how far to take 22 that, that logic, but I think my personal202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 opinion is that we're getting ahead of 2 ourselves with those data. 3 CHAIRMAN SAMET: And I think it 4 did come up in our discussion yesterday. When 5 you're talking about the need to explore the 6 sort of settling multiple factors in some 7 organized way to try and understand the 8 difference between sort of place, person, et 9 cetera, and we -- 10 DR. GRANTZ: Yes. Well, there are 11 regional differences, even with health 12 responses and whatnot. 13 CHAIRMAN SAMET: Right. 14 DR. GRANTZ: But in this case, 15 we're basing -- and it becomes even more 16 critical when you look at the policy 17 assessment, that we're starting to base the 18 entire standard now on visibility. And that 19 is based on these limited preference studies. 20 So I say in my written comments 21 that it's probably appropriate to move forward 22 on the basis of available data, but I don't Page 123 1 think this panel should endorse the 2 comprehensiveness, let's say, of those data. 3 They remain -- the logit analysis, 4 which is the question to be answered here, 5 contributed a lot. 6 CHAIRMAN SAMET: No. 7 DR. GRANTZ: But it doesn't add 8 any more data to the field as far as -- 9 CHAIRMAN SAMET: Right. But there 10 are research needs that come out of this. I 11 think the logit analysis shows clearly and I 12 think our public comment or comment on this 13 that there is heterogeneity confirmed by the 14 statistical analysis. 15 DR. GRANTZ: My main point is that 16 that is not reflected in here. 17 CHAIRMAN SAMET: Right, right. 18 And then I think where the implications come 19 is really in the next step, in the policy 20 analysis, like you do when you have the data 21 you have at hand show heterogeneity. And then
22 -- Page 124

1 DR. GRANTZ: But these comments 2 have to show our take on looking at the graphs 3 in this visibility analysis. And my take on 4 those graphs is that you can draw a line 5 through the middle of the distribution. It 6 doesn't necessarily mean that's a very good 7 thing to do. 8 CHAIRMAN SAMET: Right. 9 DR. GRANTZ: And it's certainly 10 not in -- 11 CHAIRMAN SAMET: Right, right. 12 DR. GRANTZ: I mean, I would like 13 this panel to endorse that we're done with 14 that. 15 CHAIRMAN SAMET: Yes, yes. And I 16 think, actually, the part we'll see in the 17 next step, which is if these are all of the 18 data you have at hand and you are going to use 19 them and you have heterogeneity, then you have 20 to interpret it. 21 DR. GRANTZ: Yes. I mean, in a 22 way, it is a funny thing, having seen the Page 125 1 policy assessment because I think I can make 2 these comments based only on having seen that 3 graph. 4 You know, I see four separate 5 lines. And there is a line drawn through the 6 middle, which is a reasonable thing to do with 7 limited data. But it's by no means a robust 8 answer. 9 So I would like that paragraph to 10 reflect that while it's in some ways 11 reasonable to move forward with looking for a 12 central pendency, the data don't strongly 13 support that. And further research is 14 strongly recommended, something along those 15 lines. 16 CHAIRMAN SAMET: Okay. Yes? 17 MR. POIROT: I think it's a very 18 important issue that I would like to see us 19 carefully craft the language because, on the 20 one hand, you know, an extreme critique of it 21 would make it a kind of a game-breaker. And 22 I don't believe that it's a game-breaker202-234-4433 Neal R. Gross & Co., Inc. Page 126 1 necessarily. So I would -- 2 DR. STALLWORTH: How about this 3 compromise I was just trying to figure out? 4 While it's appropriate to move forward on the 5 basis of available data, the panel believes 6 the data suggest some heterogeneity that 7 should be explored with further research. 8 MR. POIROT: That works for me. 9 DR. GRANTZ: I think the 10 game-breaker problem is addressed in the next 11 step. You know, I just think as we move 12 along, we would present an analysis. And we 13 have to give our opinion about that analysis, 14 not where it is going to go. 15 Technically we shouldn't have seen 16 the PA yet, really, when we're done with 17 events. But since we are heading for a 18 visibility standard, it becomes that much 19 longer. 20 So I'm fine with that wording. 21 Thank you. 22 CHAIRMAN SAMET: Okay. Good. Page 127 1 Okay. And anything else, I mean, we have to 2 be in -- and we can get Chris or Joe to do 3 this, some combination of what has been 4 written. You know, the analyses are useful. 5 They're straightforward. They're presented 6 well. And I think that we can say. And I 7 think both Chris and Joe say that, perhaps in 8 too much length, but we can edit that. 9 Okay. Anything else on 10 visibility? 11 (No response.) 12 DR. GRANTZ: I know Chris and Joe 13 have comments. Are you going to combine those 14 or -- 15 DR. RUSSELL: Yes, yes. We'll 16 take care of it. 17 DR. STALLWORTH: I'll probably ask 18 Rich Poirot to smooth it out. 19 CHAIRMAN SAMET: Okay. So let's 20 talk about the process for moving forward on 21 these two letters. So, Frank, you need to 22 work on responses to 6 with your colleagues. Page 128 1 DR. SPEIZER: I actually thought 2 that we had worked that down to something that 3 you have been keeping track of, Holly. 4 DR. STALLWORTH: I made pretty 5 good notes. John, I thought you would take a 6 risk assessment letter and give it a good -- 7 CHAIRMAN SAMET: All right. 8 That's fine. I was just trying to be gentle. 9 All right. Okay. 10 DR. STALLWORTH: And, likewise, 11 Rich, I can send you my most recent file. If 12 you could take that and smooth it out based on 13 the comments? 14 CHAIRMAN SAMET: Okay. But we 15 will need to bring these letters to closure. 16 And so that -- 17 DR. STALLWORTH: We'll do that 18 soon. 19 CHAIRMAN SAMET: So, as I say, 20 what we would like to do, then, is circulate 21 and -- 22 DR. STALLWORTH: A draft that you Page 129
1 have edited. 2 CHAIRMAN SAMET: A draft that Rich 3 has edited and then I guess any last 4 discussion on our April 8th call. 5 DR. STALLWORTH: Right, right. 6 I'll incorporate all comments by e-mail. And 7 then we'll post it and discuss both of these 8 letters on April 8th, but hopefully that will 9 be a short discussion. 10 CHAIRMAN SAMET: Okay. 11 DR. STALLWORTH: So maybe next 12 week we'll send these letters out, Monday. 13 CHAIRMAN SAMET: I would think so. 14 Yes. So you'll send texts to me, texts to 15 Rich with -- 16 DR. STALLWORTH: I just sent you 17 that, right? 18 CHAIRMAN SAMET: You just did. 19 Okay. All right. I'll send it to Frank. No. 20 So, anyway, we will do that. Chris. 21 DR. STALLWORTH: Just in the nick 22 of time.202-234-4433 Neal R. Gross & Co., Inc. Page 130
1 CHAIRMAN SAMET: Just in the nick 2 of time. We're almost getting to the end, but 3 don't worry. But thanks. Actually, just to 4 update you, we have gone through drafts, which 5 are sitting there, of the two letters. 6 And so there is both sort of the 7 overall letter, the main messages, and then 8 there is for each response to the charge 9 questions. 10 I think on the pieces that you had 11 written, there was general agreement that you 12 had covered the right stuff and the feeling 13 that some of the material was too long. 14 On the charge question, I think it 15 was two on visibility. Both you and Joe had 16 written something. And it will need to be 17 amalgamated. And Rich is going to do that. 18 DR. FREY: Okay. 19 CHAIRMAN SAMET: So that you don't 20 have to worry about doing. 21 DR. FREY: All right. HIGHLIGHTS 22 AND DISCUSSION OF CHARGE QUESTIONS FOR Page 131

1 UPCOMING REVIEW OF POLICY ASSESSMENT 2 CHAIRMAN SAMET: I think that is 3 where we are. We are talking about the 4 process now for finishing off these letters. 5 DR. FREY: Okay. 6 CHAIRMAN SAMET: Yes. And so 7 we'll circulate comments, try and minimize 8 wordsmithing. Concept-smithing is okay. And 9 that gets to final discussion April 8th. So 10 that's where we want to be. 11 Okay. So then the other issue is 12 the review of the policy assessment. And, you 13 know, as of now, we are scheduled to have I 14 guess 4 hours on the 8th and 4 hours on the 15 9th -- 16 DR. STALLWORTH: If needed. 17 CHAIRMAN SAMET: -- if needed to 18 discuss the policy assessment. We are going 19 to get reworked charge questions, although 20 presumably the general areas will be roughly 21 the same. 22 DR. STALLWORTH: The coverage will Page 132

1 be the same. 2 CHAIRMAN SAMET: Will be the same. 3 And, you know, we might spend a few moments. 4 I mean, in a way we have been sort of making 5 the assignments is that Holly sort of does 6 what seems logical and appropriate. And I 7 usually say, "Yes, it looks fine." And then 8 we send it out. And every now and then 9 somebody wants to take on one or another -- 10 DR. STALLWORTH: Right. Well, I 11 can -- 12 CHAIRMAN SAMET: -- charge 13 question, makes a movement. But we can do 14 that. We can go to the charge questions that 15 we have now and see if the people want to take 16 on any particular -- 17 DR. STALLWORTH: It would be great 18 if people want to volunteer for -- 19 CHAIRMAN SAMET: -- volunteer for 20 -- 21 DR. STALLWORTH: It makes my life 22 easier. Page 133

1 CHAIRMAN SAMET: So if we actually 2 pull up yesterday's -- and, you know, I think 3 we'll have some challenge in discussing these 4 by phone simply because of the scope of the 5 document and the difficulty of the concepts we 6 are going to cover. 7 So, just to go through real quick, 8 there was this first set of over-arching 9 questions that related to things like 10 organizational structure and technical 11 content. This is probably one no one 12 particularly wants to volunteer for. 13 DR. BRAIN: I'll volunteer for 14 one. 15 DR. STALLWORTH: Are you going to 16 write notes? 17 CHAIRMAN SAMET: Yes, I'll make 18 notes. Okay. So, Joe, maybe if you took on 19 these two? I think they go together in any 20 case. 21 And we'll put you down as leader 22 on organizational structure and technical202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 content. And we'll give you Sverre. 2 DR. BRAIN: Or he can do two and 3 I'll do one or we can work together. 4 DR. VEDAL: I've got some meatier 5 things here, guys. 6 CHAIRMAN SAMET: Okay. We'll 7 figure it out. If Joe takes the lead on those 8 two, then it would be okay. 9 Then the next batch relates to the 10 primary standard for fine particles. And 11 there is one on approach and this referring to 12 how information is used in addressing the 13 development of the standards and use of the 14 epidemiological information. 15 It kind of sounds like you, 16 Sverre. Was this -- 17 DR. VEDAL: I didn't X it, but 18 I'll do it. 19 CHAIRMAN SAMET: So you'd be 20 three. And then the next is four, adequacy of 21 the current suite of standards. So we're 22 going to essentially go through the whole Page 135 1 thing. 2 We have a lot. I mean, there is 3 going to be a lot of work to do because we 4 have fine particle, coarse particle, and then 5 invisibility, and welfare. So it's a lot to 6 cover. 7 DR. LIPPMANN: There are plenty of 8 questions, -- 9 CHAIRMAN SAMET: Yes. 10 DR. LIPPMANN: -- which is more 11 than the number of members. 12 CHAIRMAN SAMET: Right. No. Some 13 people are going to have to repeat. And I 14 think it makes sense to -- 15 DR. LIPPMANN: No. Maybe the 16 approach if it's in both, one person can 17 handle the approach on both. 18 CHAIRMAN SAMET: Although I will 19 say they are quite distinct in the approaches 20 given the different amount of evidence 21 available. 22 DR. STALLWORTH: Karen had a Page 136

1 comment. 2 CHAIRMAN SAMET: Karen, go ahead. 3 DR. MARTIN: I just had a point of 4 clarification that these questions are by 5 chapter. 6 CHAIRMAN SAMET: Yes. 7 DR. MARTIN: So question 3 is 8 about the approach we use for looking at the 9 fine particle -- 10 CHAIRMAN SAMET: Right. Which is 11 different, right. 12 DR. MARTIN: And question 4 is 13 only about adequacy of the fine particle 14 primary standards. 15 CHAIRMAN SAMET: Right. 16 DR. MARTIN: Those questions will 17 come up again in the other chapters. So these 18 aren't all-encompassing questions. 19 CHAIRMAN SAMET: Right. 20 DR. MARTIN: Okay. 21 CHAIRMAN SAMET: Thanks. So I 22 think the approach here, that's where we -- I Page 137 1 think that would work. Okay. And then 2 there's this adequacy of the current suite of 3 standards. 4 DR. SPEIZER: I'm willing, but I 5 also would like to be on the coarse particles 6 as well. 7 CHAIRMAN SAMET: You can have two. 8 DR. SPEIZER: Okay. 9 CHAIRMAN SAMET: Okay. So Frank. 10 Then the -- 11 DR. CASCIO: I'll work with Frank 12 on that one as well. 13 CHAIRMAN SAMET: Okay. 14 DR. STALLWORTH: On number 4? 15 Okay. 16 DR. CASCIO: Also on coarse 17 particles as well. 18 CHAIRMAN SAMET: Okay. And then 19 indicator? 20 DR. LIPPMANN: I'll volunteer for 21 that. 22 DR. PHALEN: Yes. I'll volunteer202-234-4433 Neal R. Gross & Co., Inc. Page 138
1 with Mort also. 2 CHAIRMAN SAMET: Okay.**DR. PHALEN: 3 Thanks. 4 CHAIRMAN SAMET: Okay. And do you 5 potentially want to take what comes with 6 indicator, or the averaging time in the form, 7 or, Helen, do you want to do the form? 8 DR. SUH: Yes, that's fine. 9 CHAIRMAN SAMET: Ted? Okay. 10 DR. STALLWORTH: So we're putting 11 Mort and Bob on -- 12 CHAIRMAN SAMET: Would you take 13 the averaging time, too, Mort? Would you take 14 the averaging time, too, for -- 15 DR. LIPPMANN: Okay. And I'm on 16 5, not as confident on 6. 17 DR. STALLWORTH: That's okay. 18 CHAIRMAN SAMET: That's okay. All 19 right. And then 8 is levels. 20 PARTICIPANT: Have I got forms? 21 CHAIRMAN SAMET: Helen is going to 22 do forms. Page 139

1 PARTICIPANT: Okay. 2 CHAIRMAN SAMET: And then 8 is 3 levels. 4 DR. HENDERSON: I have a conflict 5 and can't be on the call, but I would be glad 6 to help anybody writing up. 7 CHAIRMAN SAMET: So we probably 8 should have somebody. So we put you by it, 9 but I think we probably should have somebody 10 who will be on the call. 11 DR. SUH: Well, do you want me to 12 do it? And then I can work with Rogene, then. 13 CHAIRMAN SAMET: Okay. That's 14 fine. Thanks. So we've got Helen and Rogene 15 for that. 16 DR. STALLWORTH: And, Helen, 17 you're also taking number 7? 18 CHAIRMAN SAMET: Yes, she's taking 19 form. 20 DR. STALLWORTH: All right. 21 CHAIRMAN SAMET: Okay. And then 22 primary standard for thoracic coarse. Let's Page 140 1 see, Wayne, you were -- is that Wayne and 2 Frank? Okay. Let's see. This is Frank and 3 Wayne. 4 Indicator? 5 DR. LIPPMANN: I'm doing indicator 6 on the fine. I'll be happy to do it on the 7 coarse, too. 8 CHAIRMAN SAMET: Okay. 9 DR. VEDAL: It's more challenging, 10 Mort. 11 CHAIRMAN SAMET: Ted, should you 12 be on indicator for coarse? 13 DR. RUSSELL: I could be. 14 CHAIRMAN SAMET: You could be? 15 DR. RUSSELL: Should and could 16 are two different words. 17 CHAIRMAN SAMET: Do you want to 18 be? 19 DR. RUSSELL: That's fine. 20 CHAIRMAN SAMET: Okay. 21 DR. HENDERSON: It's much more 22 complicated. Page 141

1 CHAIRMAN SAMET: I think you would 2 be helpful on that one. So we have averaging 3 time, form, and levels. All right. Well, the 4 averaging time is probably a relatively 5 straightforward discussion. Can I just put 6 that on, add that on, for you? I'll put you 7 and Ted. 8 DR. SPEIZER: I guess because I 9 can read the whole thing, I'll probably make 10 comments on the whole thing. 11 CHAIRMAN SAMET: Was that 12 volunteering for something? 13 DR. SPEIZER: It's volunteering, 14 but I don't know for what. 15 CHAIRMAN SAMET: For which one, 16 Frank? 17 DR. SPEIZER: For all the factors 18 in the coarse. 19 CHAIRMAN SAMET: On the coarse. 20 Oh, okay. Okay. So maybe -- 21 DR. STALLWORTH: Which number is 22 that, Frank?202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 DR. SPEIZER: Well, it's -- 2 CHAIRMAN SAMET: Well, you're 3 talking about 10, 11, 12, and 13. 4 DR. SPEIZER: Yes, 10 to 13. 5 DR. STALLWORTH: Okay. 6 CHAIRMAN SAMET: So do you want to 7 take the lead on the level, Frank? 8 DR. SPEIZER: If you'd like. 9 CHAIRMAN SAMET: Okay. 10 MR. AVOL: So, Jon, we're coming 11 to the end of the health part, and I've not 12 been assigned anything. 13 CHAIRMAN SAMET: Oh, I've missed 14 you. You've been too quiet. 15 MR. AVOL: I've worked with Rogene 16 and Helen on the -- and I'll get in on the -- 17 CHAIRMAN SAMET: No. We're going 18 to go back and fill in so I haven't -- we 19 haven't assigned 12. That's the form. So, 20 Ed, why don't you take the lead on it since 21 you're -- 22 MR. AVOL: Form on coarse? Page 143

1 CHAIRMAN SAMET: Yes, form on 2 coarse. 3 MR. AVOL: Okay. 4 DR. LIPPMANN: Jon, on health, 5 before we move on to visibility, I had sent a 6 brief paragraph to Holly overnight about a 7 charge question which isn't there and should 8 be. It's only a paragraph. Why don't I read 9 it? 10 CHAIRMAN SAMET: Okay. 11 DR. LIPPMANN: "The policy 12 implications of reliance on the core CR 13 functions or annual mortality associated with 14 long-term PM 2.5 exposures in the face of the 15 core CRB well below the lower end of the 16 alternative risk mile specifications needs to 17 be discussed within this VA document, 18 especially in terms of the magnitude of the 19 most likely mortality in it. 20 "It is not sufficient to say, as 21 on page 2-48, that 'These considerations 22 increase our overall confidence that we did Page 144
1 not overstate risk with the core risk 2 estimates.' 3 "There should be a discussion of 4 the policy implications of underestimating the 5 true risks and a charge to the CASAC PM panel 6 to discuss this issue at its next meeting. It 7 will certainly be an important consideration 8 when margin of safety is considered." 9 DR. VEDAL: So let me ask this. 10 So this has to do with coarse and the 11 long-term? 12 DR. LIPPMANN: It's strictly fine 13 -- 14 DR. VEDAL: I misunderstood. 15 DR. LIPPMANN: -- related to the 16 annual CR for fine being at the low end by a 17 factor of about three of the alternative 18 models which were judged to be scientifically 19 credible, including University of Washington. 20 So there are policy implications 21 in the estimate of the risks when relying on 22 a CR, the extreme low end. Page 145

1 CHAIRMAN SAMET: Okay. 2 DR. VEDAL: I mean, this was grist 3 for the mill for our risk assessment 4 discussion.
5 CHAIRMAN SAMET: Yes. 6 DR. LIPPMANN: Well, but its 7 character will be carried over from the risk 8 assessment as the base core model. And what 9 are the policy implications of that? 10 DR. VEDAL: Well, I mean, there 11 are a lot of reasons. Well, there is no point 12 discussing it now. But no sensitivity 13 analysis and those other cohorts that even 14 come close to those that were done in ACS. 15 DR. LIPPMANN: That doesn't mean 16 that they are necessarily far along. 17 DR. VEDAL: No. 18 DR. LIPPMANN: No. I think due 19 attention and respect needs to be shown for 20 that. But I think there are policy 21 implications which need to be discussed. We 22 need to be charged with discussing the policy202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 implications. 2 CHAIRMAN SAMET: Well, in 3 addition, I would just note that I think we 4 are free to, as we have always done, make 5 comments that extend beyond the charge 6 questions. 7 So I think we can either keep 8 this, your note, with us and flag it for 9 discussion on April 8th or we can forward it 10 and have it incorporated into -- 11 DR. STALLWORTH: Into the RA? 12 Into the -- 13 CHAIRMAN SAMET: Well, I mean, I 14 think we can -- 15 DR. STALLWORTH: Into the PA? 16 CHAIRMAN SAMET: Yes, PA. Yes. 17 DR. STALLWORTH: Okay. 18 DR. LIPPMANN: Well, Holly has my 19 next -- 20 CHAIRMAN SAMET: Okay. 21 DR. LIPPMANN: If you want to use 22 it, it's available to you. Page 147

1 CHAIRMAN SAMET: Let me look at 2 it. And I'll -- 3 DR. STALLWORTH: Okay. 4 CHAIRMAN SAMET: And we have a 5 note from Tom. He would like to be with 6 question 1 and then 14-17, which we're getting 7 to now, of course, the visibility. 8 So I think we covered the 9 health-related questions. So then we are on 10 to the visibility, where we have adequacy 11 indicator averaging times and levels and form. 12 And we're missing a lot of our 13 team. 14 DR. ASHBAUGH: Jon, before we go 15 on, I just noticed that chapter 4 has only an 16 odd number of pages. 17 CHAIRMAN SAMET: Okay. 18 DR. ASHBAUGH: It's double-sided 19 and then copied single-sided and double-sided, 20 but all of the even-numbered pages are missing 21 throughout chapter 4. 22 DR. STALLWORTH: Of? Page 148

1 DR. ASHBAUGH: Of the PA. 2 CHAIRMAN SAMET: Of the PA? 3 DR. ASHBAUGH: At least in my 4 copy. I just have odd-numbered pages. 5 DR. BRAIN: And my copy as well. 6 It's double-sided, but, again, it's missing 7 even pages. 8 DR. ASHBAUGH: Yes. It looks like 9 the other chapters are okay, but chapter 4 is 10 missing -- 11 DR. SUH: My chapter 4 is okay. 12 PARTICIPANT: Yes. Mine is okay. 13 DR. ASHBAUGH: I was trying to 14 look at some of it, but I was missing a page. 15 CHAIRMAN SAMET: Okay. So, 16 anyway, we're going to get a new chapter 4. 17 DR. ASHBAUGH: With that, I will 18 take -- 19 CHAIRMAN SAMET: Well, what is the 20 amongst the visibility -- so do you want to 21 take on 14? And 15. So this is the 22 indicator. So this is a major discussion, of Page 149

1 course. 2 DR. GRANTZ: I think Rich should 3 do that. 4 CHAIRMAN SAMET: So you're 5 suggesting Rich? 6 DR. GRANTZ: Yes. 7 CHAIRMAN SAMET: This is what 8 happens when you leave. 9 DR. GRANTZ: I'll help him, but -- 10 PARTICIPANT: Well, I'll be happy 11 to help him, too. 12 CHAIRMAN SAMET: Okay. And 13 averaging time? This goes with it, doesn't 14 it? 15 DR. GRANTZ: It does. Rich isn't 16 here. 17 CHAIRMAN SAMET: All right. So 18 Rich. So this is the lead person. All right. 19 Levels and form. Let's give Rich a break. 20 DR. RUSSELL: Actually, is Bill 21 going to be back for our meetings, too? He 22 may be.202-234-4433 Neal R. Gross & Co., Inc. Page 150
1 DR. STALLWORTH: He will be back 2 in time for the April 8th discussion, yes. 3 DR. RUSSELL: You may want to -- 4 CHAIRMAN SAMET: Who did we want 5 to save him for? 6 DR. RUSSELL: He may want to take 7 some of this as well. 8 DR. STALLWORTH: Which one? Which 9 one would you give to Bill? I'm sorry? 10 MR. AVOL: Let's give Bill 17. He 11 could easily do 15 as well. 12 DR. RUSSELL: Yes. That's what I 13 was thinking. 14 CHAIRMAN SAMET: And then we have 15 other welfare-related effects. So we have 16 climate. 17 DR. GRANTZ: I think I could 18 probably take 19 and 20. Climate I'm not -- 19 CHAIRMAN SAMET: Okay. That's 20 probably right. Thanks. Do you want to do 21 climate? 22 DR. FREY: Sure. Page 151

1 CHAIRMAN SAMET: Chris will do 2 climate. 3 DR. STALLWORTH: So this means in 4 your revision, you've got to stick to the same
5 structure. 6 CHAIRMAN SAMET: And Ted? So I 7 put both of you. 8 DR. RUSSELL: And Phil also makes 9 sense on -- Phil also makes -- 10 CHAIRMAN SAMET: Actually, Phil we 11 should have had -- we have not gotten him into 12 some of the -- 13 DR. RUSSELL: Yes. He hasn't 14 gotten anything. 15 CHAIRMAN SAMET: -- PM issues. 16 This is a good tactic. You leave, and then 17 you are forgotten. 18 DR. RUSSELL: Usually it works the 19 other way. 20 CHAIRMAN SAMET: I know. I know. 21 So, actually, let's go back and think about -- 22 well, would he be good for the indicator on Page 152 1 visibility discussion? 2 DR. STALLWORTH: Which one is 3 that? 4 CHAIRMAN SAMET: Fifteen. 5 DR. ASHBAUGH: I think we can 6 split 15 and 16. 7 DR. STALLWORTH: Okay. Right now 8 I have them together with Poirot, Grantz, and 9 Ashbaugh. Should we split off? What was it, 10 15, Hopke and Malm? 11 DR. ASHBAUGH: Sure. 12 DR. STALLWORTH: Yes? 13 DR. ASHBAUGH: Yes. 14 DR. STALLWORTH: Okay. 15 CHAIRMAN SAMET: Yes. And we'll 16 get at least two or more discussants under 17 each of these. So we'll do that. I mean, I 18 think the initial will be -- and let's talk a 19 little bit about process. 20 DR. RUSSELL: Actually, I think 21 Phil makes sense pretty much on all of the 22 indicator ones. It might be useful to have Page 153 1 one person -- 2 CHAIRMAN SAMET: It goes across 3 all of the indicators. 4 DR. VEDAL: Maybe even form. 5 DR. STALLWORTH: So number 10 as 6 well? 7 DR. PHALEN: I was thinking of the 8 health as well. 9 DR. RUSSELL: Yes. 10 DR. STALLWORTH: Number 10 is the 11 indicator question for the risk assessment? 12 DR. ASHBAUGH: There's a separate 13 indicator question. 14 DR. PHALEN: Yes, also was 15 indicator. I think he would be good on 5. 16 DR. STALLWORTH: Okay. 17 DR. PHALEN: Would his comments on 18 the overall organizational structure be 19 helpful? Who is on that now? 20 DR. STALLWORTH: Joe Brain. 21 CHAIRMAN SAMET: Joe, we'll put 22 others on, I mean, for sure. Now, we'll end202-234-4433 Neal R. Gross & Co., Inc. Page 154 1 up with three or four people on each of these. 2 It's just really a question of who it will be, 3 make sure we have somebody who is in the lead 4 and wants to be. 5 Frank? 6 DR. SPEIZER: And, Holly, you are 7 going to send around a list? 8 DR. STALLWORTH: Yes. 9 DR. SPEIZER: Can we legally 10 communicate within the subgroups? 11 DR. STALLWORTH: Yes. 12 DR. SPEIZER: And that seems to me 13 what we should do because that way we can come 14 up presumably with one presenter at the -- 15 DR. STALLWORTH: Yes. That 16 actually works better, Frank. That's what we 17 did for the last meeting. 18 PARTICIPANT: And who was on 17? 19 CHAIRMAN SAMET: Seventeen is 20 Bill. 21 PARTICIPANT: Thank you. 22 CHAIRMAN SAMET: We'll get more. Page 155 1 And that actually will be the -- with 20 2 questions, that is a lot of subgroups. So 3 people will end up on multiple subgroups. And 4 just the communications will be a little bit 5 of a -- 6 DR. STALLWORTH: Messy. 7 CHAIRMAN SAMET: -- messy. So 8 maybe if you can sort of call yourselves the 9 question 1 subgroup, et cetera, or something 10 so you can keep track of the e-mail flow, 11 which sometimes is challenging? And so if the 12 designated leaders could take charge of this? 13 The call -- let's see. We will 14 have public comment. 15 DR. STALLWORTH: Probably. 16 CHAIRMAN SAMET: We will probably 17 have public commenters. When we have our 18 call, are you planning on making any more 19 remarks? 20 DR. MARTIN: I think we might want 21 to make some short remarks. 22 CHAIRMAN SAMET: I'm just trying Page 156 1 to think about the time. Okay. We will have 2 to see how many public commenters we have. If 3 we set aside a half-hour and reduce the time 4 to three minutes, that would be -- it is still 5 going to take us probably 30 or 40 minutes to 6 get started with getting to a point where we 7 move to Committee discussions, which means if 8 we have 20 items, I mean, even if we take 10 9 minutes each, it's a lot of time. And some of 10 these, of course, need substantial discussion. 11 DR. STALLWORTH: And we're asking 12 for preliminary written comments. 13 CHAIRMAN SAMET: So I think if we 14 have preliminary written comments, we have to 15 see how this does. I mean, we will have to 16 keep track of time. But if we went on for 15 17 minutes each and we're heading up towards -- 18 it's a lot of time. 19 So it is likely that we will need 20 both. I can't imagine we won't need both days 21 of time that you should have set aside in your 22 calendars. Page 157

1 DR. STALLWORTH: Let me suggest 2 with the visibility questions, this is such a 3 small subgroup that everybody can be on 14 4 through 19. 5 CHAIRMAN SAMET: Yes. I agree. 6 DR. STALLWORTH: Okay. 7 DR. HENDERSON: Will we see a copy 8 of what is preliminary before the call coming 9 if you combine every? That should shorten it 10 up. 11 DR. STALLWORTH: Yes. That does 12 help to shorten the discussion. 13 DR. ASHBAUGH: So will you send us 14 some timeline on when we need to get those in 15 to -- 16 DR. STALLWORTH: Well, we can 17 discuss it right now. I will send out the 18 assignment. A week from today? Two weeks 19 from today? 20 CHAIRMAN SAMET: To get the 21 comments in? 22 DR. STALLWORTH: Preliminary202-234-4433 Neal R. Gross & Co., Inc. Page 158
1 written comments to me on -- 2 CHAIRMAN SAMET: Oh, I think we 3 should give more time 4 DR. STALLWORTH: We need revised 5 charge questions. 6 CHAIRMAN SAMET: We need revised 7 charge questions. And I think people need a 8 couple of weeks to wade through this. 9 DR. STALLWORTH: Two weeks? 10 CHAIRMAN SAMET: I think if you 11 had, even by the end of the month, Holly, 12 because, remember, our call is April 8th and 13 9th. I think we just need to have this in 14 front of us. So I would say by month's end 15 should be the goal. 16 DR. ASHBAUGH: So the process here 17 is to give comments on something we are not 18 assigned to, just communicate with the lead 19 person on that? 20 CHAIRMAN SAMET: Yes. 21 DR. ASHBAUGH: You know, if I have 22 comments on overall structure and -- Page 159

1 CHAIRMAN SAMET: Sure, sure. Just 2 send them to the lead. 3 DR. ASHBAUGH: Okay. 4 CHAIRMAN SAMET: And you'll get 5 new charge questions revised, a list of who is 6 on what. And we'll fill things out in some 7 logical way so that there are at least three 8 or four people per question. 9 DR. ASHBAUGH: Okay. 10 CHAIRMAN SAMET: Okay? 11 DR. PHALEN: A comment. It seems 12 like it would be helpful if those three or 13 four people would communicate also and work 14 out some of their differences so that we don't 15 have extended -- 16 CHAIRMAN SAMET: That was the 17 suggestion, actually. 18 DR. STALLWORTH: That was the 19 idea. 20 CHAIRMAN SAMET: That was the 21 idea, right, the fact that the leader on each 22 would -- Page 160 1 DR. ASHBAUGH: Together in one set 2 of written comments. 3 DR. PHALEN: In advance of the 4 call? 5 DR. ASHBAUGH: Yes. 6 DR. PHALEN: Okay. 7 DR. ASHBAUGH: And then I guess 8 the lead will send them to Holly, and Holly 9 will combine everything. 10 DR. RUSSELL: So at the time of 11 the call, only the leader will present that 12 subcommittee's opinion? 13 CHAIRMAN SAMET: Well, yes, 14 preferably the discussion will be led by the 15 leader. I mean, I think others will feel free 16 to chime in as needed or if they have other 17 view or whatever, but I think I the leader for 18 such streamlining things could do this, -- 19 DR. RUSSELL: Yes. 20 CHAIRMAN SAMET: -- I think that 21 would be helpful. 22 DR. SUH: So I'm sorry. You might Page 161 1 have mentioned this. Are we expected to have 2 a conference call with our group prior? No? 3 CHAIRMAN SAMET: No. E-mail. 4 DR. GRANTZ: That's not precluded, 5 is it, legally? I think that might be useful, 6 actually. 7 CHAIRMAN SAMET: Well, sure, I 8 mean, if you think that would be -- 9 DR. GRANTZ: That's okay to do? 10 DR. SUH: Well, one other thing is 11 that it might be useful to have somebody who 12 spans. I don't know if that is useful. I 13 mean, I guess if there is no conference 14 calling, then maybe it doesn't matter. 15 I am wondering if there is some 16 way of -- Phil would be on maybe all of the 17 indicator groups or something like that. I 18 don't know if that's -- I'm not sure. So 19 scratch that comment. 20 CHAIRMAN SAMET: Okay. 21 DR. GRANTZ: Yes. I think we have 22 to be a little careful not to wipe out all202-234-4433 Neal R. Gross & Co., Inc. Page 162 1 heterogeneity of opinion before we get to the 2 conference. 3 DR. STALLWORTH: That's true. 4 CHAIRMAN SAMET: I can't imagine 5 that happening. 6 DR. GRANTZ: We are drifting in 7 that direction. 8 CHAIRMAN SAMET: Okay. Anything 9 else? 10 DR. STALLWORTH: I can't think of 11 anything. So we should finish the subgroups. 12 CHAIRMAN SAMET: Yes, yes. Sure. 13 You mean with people? 14 DR. STALLWORTH: I will send out 15 the assignments for the policy assessment 16 charge questions. We will get a revised 17 visibility letter from Rich Poirot. 18 DR. SPEIZER: When will we get the 19 revised charge questions? 20 DR. STALLWORTH: Karen is saying 21 this afternoon she will send it to me. 22 DR. MARTIN: Yes. Page 163

1 DR. STALLWORTH: So I'll check my 2 e-mail tomorrow or this afternoon and send it 3 out. 4 CHAIRMAN SAMET: Okay. I think we 5 are done. We still have an awful lot of work 6 ahead. And then, Karen, just to remind us, I 7 don't have the timetable right in front. The 8 second complete draft -- 9 DR. MARTIN: The second complete 10 draft will be available the end of May for our 11 late June meeting. 12 DR. SPEIZER: Will that be a 13 face-to-face meeting or will that be -- 14 CHAIRMAN SAMET: That's a -- 15 DR. MARTIN: We always welcome a 16 face-to-face meeting, especially on policy. 17 CHAIRMAN SAMET: I think we'll 18 discuss that. We'll figure that out, Frank. 19 I mean, it's unfortunate we're not having this 20 next meeting face to face, but we aren't. And 21 it could be that the second meeting, we will 22 look for a way to have that face-to-face. Page 164 1 DR. STALLWORTH: I mean, depending 2 on the heterogeneity of opinion about the 3 policy assessment. If it's a lot of the 4 discussion that needs to take place, it should 5 be face-to-face. 6 CHAIRMAN SAMET: Okay. Well, I 7 think we are done. I want to thank everybody 8 for the hard work working into the night last 9 night and getting things done. 10 Good trip home. And we'll talk 11 soon, April 8th and 9th. This will be, of 12 course, a no-e-mail/texting conference call, 13 absolutely focused on what you're doing. So 14 we'll be talking then. Thanks. 15 (Whereupon, the foregoing matter 16 was concluded at 10:51 a.m.) 17 18 19 20 21 22

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