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 U.S. ENVIRONMENTAL PROTECTION AGENCY

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 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 PARTICULATE MATTER REVIEW PANEL

 + + + + +

 PUBLIC MEETING

 + + + + +

 WEDNESDAY 

 MARCH 10, 2010

 + + + + +

 The meeting convened in Salon ABC

of the Marriott Research Triangle Park, 4700

Guardian Drive, Durham, North Carolina, at

8:30 a.m., Jonathan Samet, Chairman,

presiding.

 CASAC MEMBERS PRESENT:

 JONATHAN SAMET, Chairman

 JOSEPH BRAIN

 H. CHRISTOPHER FREY

 ARMISTEAD RUSSELL

 HELEN SUH
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 PANEL MEMBERS PRESENT:

 LOWELL ASHBAUGH

 ED AVOL

 WAYNE CASCIO

 DAVID GRANTZ

 JOSEPH HELBLE

 ROGENE HENDERSON

 PHILIP HOPKE

 MORTON LIPPMANN

 ROBERT PHALEN

 RICH POIROT

 FRANK SPEIZER

 SVERRE VEDAL

 SCIENCE ADVISORY BOARD STAFF:

 HOLLY STALLWORTH, Designated

 Federal Officer

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 TABLE OF CONTENTS

AGENDA ITEM PAGE

Convene Meeting and Welcome 4

Introductions, Review of Agenda 5

Background/Schedule of NAAQS Review 9

Overview of Policy Assessment

(Chapters 1-3) 11

Highlights of Health Risk Assessment 25

Public Comments on Health Risk Assessment 75

Panel Discussion and Charge Questions for 85

Health Risk Assessment 

Overview of Policy Assessment 266

Chapters 4-5

Highlights of Urban-Focused Visibility 271

Assessment

Charge Questions 275

Highlights and Discussion of Charge 324

Questions for Review of Policy

Assessment

Adjourn 387

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1 P R O C E E D I N G S

2 (8:30 a.m.)

3 DR. STALLWORTH: I am going to go

4 ahead and start with my opening statement. It

5 is kind of like the one you have to listen to

6 from the airline stewardess.

7 I am Holly Stallworth. I am the

8 Designated Federal Officer for the Clean air

9 Scientific Advisory Panel, Particulate Matter

10 Review Panel.

11 I just want to remind everybody,

12 this is a Federal Advisory Committee. It

13 operates under the requirements of the Federal

14 Advisory Committee Act, and the Clean Air

15 Scientific Advisory Committee is empowered by

16 law to provide advice to the Administrator.

17 Consistent with the requirements

18 of FACA and with EPA policy, the deliberations

19 of this Panel are conducted in public at

20 meetings for which advance public notice is

21 given. Discussions and deliberations, the

22 interactions of the Panel with the public, and

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1 the agencies are conducted also in public in

2 sessions where I, as DFO, am present to ensure

3 that the requirements of FACA are met.

4 These include the requirements for

5 open meetings, for maintaining records, making

6 available public summaries of meetings, and

7 providing opportunities for public comment.

8 Today I have just one request for

9 public comment from the American Petroleum

10 Institute. Is that correct? Anyone else? 

11 Last, I want to say that our

12 office has reviewed financial disclosures from

13 each of you, and determined that there are no

14 conflict of interest or appearance of a lack

15 of impartiality issues.

16 I will turn the meeting over to

17 Dr. Jon Samet.

18 CHAIRMAN SAMET: Good morning,

19 everyone, and welcome to yet another CASAC

20 meeting.

21 I think, just so we can remind

22 each other who others are, a quick round of
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1 introductions of the committee for the public. 

2 So, Jon Samet from the University of Southern

3 California.

4 DR. FREY: I am Chris Frey at

5 North Carolina State University.

6 DR. LIPPMANN: Mort Lippmann, New 

7 York University.

8 MR. AVOL: Ed Avol, University of

9 Southern California.

10 DR. ASHBAUGH: Lowell Ashbaugh,

11 University of California at Davis.

12 MR. POIROT: Rich Poirot, State of

13 Vermont.

14 DR. HENDERSON: Rogene Henderson,

15 Lovelace Respiratory Research Institute. 

16 DR. RUSSELL: Ted Russell, Georgia

17 Tech.

18 DR. GRANTZ: David Grantz,

19 University of California at Riverside.

20 DR. SUH: Helen Suh, Harvard

21 School of Public Health

22 DR. BRAIN: Joe Brian, Harvard.

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1 DR. SPEIZER: Frank Speizer,

2 Harvard University.

3 DR. CASCIO: Wayne Cascio, East

4 Carolina University.

5 DR. PHALEN: Bob Phalen,

6 University of California, Irvine.

7 DR. VEDAL: Sverre Vedal,

8 University of Washington.

9 DR. HOPKE: Phil Hopke, Clarkson

10 University.

11 DR. HELBLE: Joe Helble, Dartmouth

12 College.

13 CHAIRMAN SAMET: Good. I notice

14 that the Harvard trio are all sitting in a

15 row. One is at the Harvard School of Public

16 Health, one is at Harvard, and one is at

17 Harvard University. I guess you all know

18 where you are coming from.

19 Just to remind everybody what we

20 are doing on our agenda, we are reviewing the

21 second draft, Health Risk Assessment today,

22 and then tomorrow we are turning to the urban

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1 focused visibility assessment, and we are also

2 discussing, I guess, what is now dubbed the

3 first draft policy assessment, reminding 

4 everyone that we saw the 0.2 draft of the

5 policy assessment at our last meeting.

6 We may want to look at the

7 schedule tomorrow as the day comes. In part,

8 I think the visibility may go quicker, and

9 there probably, I suspect, will be perhaps

10 more than an hour's worth of committee

11 interest in discussing on the policy

12 assessment. So maybe we can just sort of see

13 what the day looks like and how we want to

14 discuss that.

15 Also, I think, for CASAC we may be

16 able to move relatively quickly through our

17 review of the second draft Quantitative Health

18 Risk Assessment and, if we are able to do so,

19 I am going to suggest that we then try and

20 take time to work on the letter and get our

21 comments as together as possible today, I

22 think, just for efficiency.

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1 So, again, let's just see what

2 happens. Perhaps the discussions will fill

3 the time, but I suspect they will not. 

4 So I think, with that, let me turn

5 things to EPA.

6 DR. MARTIN: Good morning,

7 everyone. First of all, let me welcome you

8 all here and tell you who much we appreciate

9 your making the time in your schedules to

10 participate in this.

11 I also want to extend greetings

12 from Lydia Wegman who, because of prior travel

13 commitments, wasn't able to be here. She was

14 very sorry to be missing this meeting.

15 What we wanted to do, as outlined

16 on the agenda here, was first of all, just to

17 touch on the schedule for where we are in the

18 review schedule and what is coming next, and

19 then we were asked to provide some overview of

20 the policy assessment document, the first

21 draft of that document, which you have just

22 very recently received. 
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1 So, obviously, you haven't had a

2 chance to read it and consider it, but the

3 sense was that providing some overview of it,

4 how it is organized, the issues it deals with,

5 would help provide some context for your

6 discussions of the Health Risk Assessment

7 today and the Visibility Assessment tomorrow. 

8 So that is what we intended to do.

9 First of all, turning to the

10 schedule, what we have here is, in black type,

11 the items on the schedule associated with the

12 completed Innovative Science Assessment and

13 with the second drafts of the documents that

14 we are reviewing today that were released in

15 January and early February.

16 It also indicates that following

17 this meeting today and tomorrow on those

18 documents, we will be planning to finalize

19 those two documents in April.

20 The blue type here highlights the

21 items related to the Policy Assessment, the

22 first draft of that assessment which were just

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1 released Friday evening and, hopefully, has

2 gotten to you all by now.

3 We have the meeting scheduled with

4 you for April 8th and 9th to formally review

5 that document after you have had sufficient

6 time to read it and consider it, and we then

7 intend quite quickly to turn around a second

8 draft of that document by late May, with the

9 idea that we would ask for your review of that

10 second draft in June. 

11 The target goal is to finalize it

12 in July, and the rulemaking schedule that the

13 agency has laid out is to have a proposed rule

14 by the end of November and a final rule July

15 next year. That is an ambitious schedule, and

16 hopefully, we will all be able to keep on

17 track with that.

18 Before we get into focusing on

19 some specific elements of the Policy

20 Assessment, I just wanted to make some general

21 comments about it, about its purpose, about

22 how we think about the information it

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1 includes, how it draws from the other

2 documents that you all are looking at, how it

3 is organized.

4 Then what I want to do is turn to

5 focus now today on the chapters that

6 specifically relate to considering the primary

7 standards of Chapter 2 on fine particle

8 standards, Chapter 3 on standards for thoracic

9 coarse particles.

10 With me here are Beth Hassett11 Sipple, who is the overall project lead for

12 the PM review and also the lead author on

13 Chapter 2, and Scott Jenkins who is the lead

14 author on Chapter 3. Then tomorrow we will

15 talk about the other two chapters that relate

16 to visibility and other welfare effects.

17 First of all, just to touch on the

18 purpose of the document, the purpose of the

19 Policy Assessment document -- and this is sort

20 of a reincarnation of former staff papers that

21 some of you have seen over the years -- is to

22 serve the purpose of looking at the scientific

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1 evidence and thinking about how one can

2 translate the information derivable from those

3 scientific studies into a basis for

4 considering the adequacy of the current

5 standards and appropriate alternative

6 standards that may be appropriate for

7 consideration.

8 It is also to look at the

9 quantitative assessments that we do, the

10 health risk assessment, the visibility

11 assessment, and ask the question how do we

12 interpret that information and the

13 uncertainties surrounding that information,

14 again as a basis for evaluating the adequacy

15 of the current standards and to identify

16 potential alternative standards that are

17 appropriate for consideration.

18 In doing this, we draw directly

19 from the integrated science assessment and

20 from the documents that you are reviewing here

21 at this meeting, and in doing that, we think

22 about what information comes from that and
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1 what factors are relevant to our consideration

2 of the standards.

3 I want to just touch on this point

4 briefly because it is very important. One of

5 the things we do in all the documents we

6 produce is we include a section that outlines

7 what are the legislative requirements in terms

8 of what information is relevant to our

9 standard setting process and what information

10 is not relevant to our standard setting

11 process.

12 We try to make very sure that, in

13 laying out the reasoning and the rationale

14 that underlines our views with regard to

15 adequacy of standards and alternative

16 standards to consider, that we put in place a

17 line of reasoning based on the information

18 available to us, and make sure that we are not

19 considering factors that aren't relevant to

20 the decision.

21 One of those factors that I

22 specifically want to take note of is issues

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1 related to the cost of attaining standards or

2 even the attainability of the standards

3 themselves.

4 I think those of you who have

5 heard overview presentations I have made

6 before have heard the statement that those

7 factors simply are not permissible as a basis

8 for the reasoning that underlines the agency's

9 decisions about setting standards. 

10 So it is what you do not see in

11 the documents we present is any discussion

12 about specific measures that people might take

13 to actually attain the range of alternative

14 standards that we are identifying because that

15 isn't relevant to our consideration. 

16 The Act was intended to be

17 technology forcing. The Act was intended to

18 create standards that truly represented what

19 it took to protect public health with an

20 adequate margin of safety, what it took to

21 protect public welfare from known or

22 anticipated adverse effects, and those are the

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1 only issues that we are permitted to consider.

2 Therefore, I encourage you as

3 well, as part of your mandate in providing

4 advice to the agency, to ground your thinking,

5 to ground the reasoning that underlies the

6 advice you provide to us on factors that are

7 part of the factors that the agency can take

8 into account.

9 One observation I will make about

10 the first draft document that we have

11 presented is I am sure it is longer than you

12 were hoping it would be, and I thought, rather

13 than listening to you tell me that, I would

14 offer that observation myself.

15 I will make two points about the

16 length of the document.

17 CHAIRMAN SAMET: I am not sure

18 that is a fair strategy, actually.

19 DR. MARTIN: The best defense is a

20 good offense, or something like that, yes.

21 One observation is it is a first

22 draft, and that means we have time to take out

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1 things that got in there that are more

2 detailed than are necessary, that go off on

3 tangents that don't turn out to be relevant or

4 germane or pertinent to the judgments we need

5 to make, the conclusions we need to draw.

6 So it certainly is our goal to

7 continue to try to streamline the document as

8 we move forward, in part based on

9 consideration of your input as to what you

10 found most relevant, most useful information, 

11 that you did not find particularly useful or

12 helpful in terms of reaching the conclusions

13 that we need to reach.

14 The other observation I will make

15 about the length of the document is it will

16 necessarily, I think, in the end be longer

17 than you would ideally like it to be, and that

18 is because we feel very strongly that we need

19 to fully articulate the underlying reasoning

20 behind the conclusions we are reaching, that

21 when we put forward to the Administrator

22 conclusions and offer information for her
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1 consideration, including the advice you offer

2 her, part of the most important pieces of that

3 is the underlying reasoning, the rationale. 

4 What information are we placing weight on? 

5 What information are we deciding is not

6 deserving of placing weight on, and how do we

7 reason ourselves from the underlying

8 information to the conclusions and judgments

9 that need to be made?

10 Without that underlying reasoning,

11 our conclusions, and even your advice and

12 recommendations, have far less ability to

13 impact the decisions made. 

14 I can guarantee you the first

15 question we get when we present information to

16 the Administrator in terms of our conclusions

17 or your advice is, and what was it based on,

18 why did they say that, why did you conclude

19 that, what information were you looking at.

20 That is always the first question

21 because when the agency puts forward final

22 decisions on these standards, we need to be

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1 able to defend them; and when we defend them,

2 what we are defending isn't so much the bottom

3 line answer we reached, but it is did we have

4 a reasoned basis for getting there? Did we

5 clearly articulate how we looked at all the

6 evidence, how we looked at the risk

7 information, and how we weighted that

8 information to get to where we end up?

9 So I take this time, hopefully 

10 not trying your patience too much, to urge you

11 to think about the importance to us in

12 receiving your advice packaged together with

13 underlying rationale, underlying reasoning,

14 and part of the length that you see in the

15 policy document we create is there expressly

16 for the purpose of laying out potential ways

17 that we might develop this reasoning for the

18 purpose of giving you the opportunity to see

19 that and provide input to us on the lines of

20 reasoning that we are pursuing.

21 DR. STALLWORTH: Karen, for the

22 benefit of those of us who need to improve

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1 these letters, can you give us some examples

2 of where a CASAC letter did not provide

3 adequate reasoning for your purposes?

4 DR. MARTIN: Well, I think that,

5 rather than pointing out to one example where

6 a final letter didn't, I would just note that

7 some of the letters go into more detail with

8 regard to the underlying basis for the

9 recommendations you offer than others.

10 I can note that some individual

11 comments sometimes will point to issues that

12 aren't germane to the decisions. We sometimes

13 get input reflecting views about what range of

14 levels of standards we ought to analyze in the

15 assessment, and that was the case here with

16 some preliminary comments.

17 To the extent that those views are

18 grounded in intuition about whether or not

19 different ranges of standards might be

20 attainable, that is not a particularly useful

21 kind of input to us because we simply can't

22 use that in --

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1 DR. STALLWORTH: Right. So I am

2 trying to get a sense of what, for you, would

3 be adequate reasoning to support CASAC's

4 advice, and short of writing a dissertation

5 the length of the policy assessment, is it

6 adequate for CASAC to say, as stated in the

7 policy assessment or for the reasons stated in

8 this document or that document?

9 DR. MARTIN: Surely, it would be,

10 so long as that reflects the Committee's

11 consensus view.

12 DR. STALLWORTH: Well, sure. Of

13 course.

14 DR. MARTIN: One of the reasons

15 why we pursue different lines of reasoning in

16 the drafts of the policy assessment document

17 is to give you all the opportunity to think

18 about different ways we might go from the

19 underlying information to standards and to

20 provide us your thoughts as to those you found

21 more meriting further consideration or where

22 you found levels of discomfort in terms of how
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1 the reasoning considered evidence or risk

2 information.

3 One of the big purposes of this

4 document is to help facilitate your advice to

5 us by presenting our thinking and our

6 reasoning and giving you the opportunity to

7 weigh in on it, so weighing in on not just the

8 bottom line conclusions we reached, but the

9 process by which we got there is equally

10 important.

11 DR. STALLWORTH: Thank you.

12 DR. MARTIN: So just to wrap up, I

13 will say that the document is organized, as I

14 have said, in that series of chapters that

15 touch upon the primary standards and the

16 secondary standards and welfare effects. 

17 We lay out at the beginning of the

18 chapters approaches that have been used in

19 previous reviews in order to reason from the

20 available evidence to the decisions that were

21 made in the past reviews. 

22 We also spend some time laying out

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1 the decisions that were reached by the court

2 in the review of the 2006 Final Decisions in

3 which, as you know, the court remanded

4 decisions on the primary annual standard,

5 remanded decisions on the visibility

6 standards.

7 We thought it would be useful to

8 you and the general audience for this document

9 to take some time to lay out the reasoning

10 that was used in the past, how the reviewing

11 court thought about that reasoning and

12 incorporated into their judgments, to help

13 inform the approach we are articulating, that

14 we are taking in this review or considering

15 taking, again, to give you more background

16 basis to think about the line of reasoning

17 that you might want to work through and

18 suggest for the agency.

19 The document focuses a whole lot

20 on the underlying evidence. It also brings in

21 a lot of information about the quantitative

22 assessments and, hopefully, what you see is

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1 that in the past and now we consider that

2 looking at the evidence directly to provide a

3 very substantial amount of the information

4 that the agency will, in the end, think about

5 in reaching decisions on the standard, that

6 the quantitative assessments can be extremely

7 useful in terms of helping to make judgments

8 about the adequacy of the current standard,

9 our risk remaining big or small.

10 It can help a lot in terms of

11 helping to sort out the different roles that

12 different standards within a suite of

13 standards play, the annual versus 24-hour

14 standards; but so long as we are working off

15 concentration response functions that exhibit

16 no discernible thresholds, we will always have

17 the case that we will continue to estimate

18 risk down to the very lowest level. 

19 Therefore, it raises the question, how do we

20 appropriately characterize how uncertainty

21 increases as you continue to look at lower and

22 lower levels.

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1 With that, I think those were the

2 points I wanted to cover just as sort of a

3 general overview of our thinking about the

4 document. What I want to do now is just ask

5 Beth and Scott to walk through the underlying

6 series of questions that we use to frame the

7 discussion in the document. Our thinking was

8 that if we posed a series of questions that

9 derive from the questions that were originally

10 presented in the integrated review plan that

11 framed this review from the beginning, that it

12 would help better focus us on presenting

13 information that truly helped answer

14 questions, rather than be more expository in

15 nature and be more summarizing in nature.

16 So with that, why don't we turn to

17 Beth.

18 MS. HASSETT-SIPPLE: Karen is

19 right. The structure of this document is very

20 different than the structure of the

21 preliminary draft that you saw in September,

22 and it is, in point, to respond to your
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1 comments to make it a much more policy focused

2 document and not to reiterate the information

3 in the ISA and in the assessment document. 

4 So, hopefully, we have been able to do that.

5 What we have done is tee up two

6 overarching questions and then ask a series of

7 questions within those overarching questions

8 to get at the key policy relevant points.

9 Specifically, as we look at the

10 adequacy of the current fine particle

11 standards, we ask the question, does the

12 currently available scientific evidence and

13 risk-based information as reflected in the ISA

14 and the second draft risk assessment support

15 or call into question that adequacy of the

16 protection afforded by the current suite of

17 standards?

18 Here we look at the evidence and

19 ask a series of questions, namely, to what

20 extent does the newly available scientific

21 evidence strengthen or call into question the

22 evidence of associations between fine

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1 particles and a variety of health effects.

2 Second, what do we know

3 differently this time about susceptible

4 populations, susceptible populations that had

5 been identified in previous reviews or

6 additional susceptible populations that may

7 have been identified in this review?

8 Thirdly, we ask the question, not

9 only looking at the evidence of association,

10 but also at what levels, what air quality

11 concentrations, those associations have been

12 associated -- reported with. So here we are

13 looking at understanding the air quality

14 concentrations to see if they are lower than

15 have been previously reported or that we see

16 health effects in areas that would currently

17 meet the current standards.

18 And here we have asked for -- we

19 look at the air quality information as

20 reported in the particular studies, but we

21 have also gone out in -- OAQPS to ask for

22 additional air quality information from study

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1 authors to have a better understanding of the

2 air quality distributions evaluated in those

3 studies.

4 On the risk-based side, we also

5 look at -- we ask three specific questions to

6 look at the nature and magnitude of the long

7 term exposure and short term exposure related

8 risks remaining upon simulating just meeting

9 the current standards, and look at the

10 confidence we have in those risk estimates.

11 We also, as Karen mentioned, look

12 at the role of the annual standard and the 24-

13 hour standard and how they work together to

14 provide public health protection and 

15 specifically -- and you will see Zach and his

16 team talk about this today as you review the

17 second draft risk assessment -- look at how

18 representative the risk estimates that were

19 generated for the 15 urban case study areas

20 are from a national perspective.

21 Then we actually turn to

22 alternative standards, and we ask a second

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1 overarching question, what alternative suites

2 of standards are supported by the currently

3 available scientific information and risk4 based information, again, as reflected in the

5 ISA and in the risk assessment document.

6 Here, we look at the four elements

7 of the standards. So as we focus in,

8 questions associated with looking at

9 indicator, we ask a series of questions,

10 specifically, does the currently available

11 evidence provide support for the continued use

12 of PM2.5 as the indicator as a mass-based

13 indicator for fine particles. Secondly, does

14 the currently available information provide

15 support for considering a separate indicator

16 for additional size fractions. In particular,

17 we are focusing on ultrafine particles.

18 Lastly, we ask a series of

19 questions about PM2.5 components and sources

20 of fine particles and whether or not the

21 currently available information provides

22 support for considering a separate indicator
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1 targeting for a particular component or source

2 category of fine particles.

3 The flip side of that question is,

4 is there enough information to provide support

5 for eliminating any component or sources of

6 fine particles from the mix of fine particles

7 that would be considered within the PM2.5

8 mass-based indicator.

9 The second element of the standard

10 is averaging time. Here we ask a series of

11 questions, does the currently available

12 information continue to provide support for

13 the averaging times that are currently used,

14 the annual standard and the 24-hour standard.

15 Then a series of questions, is

16 there enough information to support other --

17 alternative averaging times, and we looked

18 specifically at an averaging time of less than

19 24 hours to specifically look at exposures --

20 sub-daily exposures. We also looked at

21 information on seasonal exposures to see if

22 there was enough information to support an

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1 alternative standard that would focus on

2 seasons.

3 The third element of the standard,

4 which is form. In Chapter 2 for fine

5 particles, we discussed the form of the

6 standard in conjunction with the level of the

7 standard. For the annual standard, we have a

8 three-year annual average that allows spatial

9 averaging, allows -- there was a tightening in

10 the 2006 decision that narrowed the

11 constraints for spatial averaging, but they

12 are still there.

13 We discussed that, and we had

14 planned to conduct some additional air quality

15 analyses to inform whether or not it is

16 appropriate to continue to retain the spatial

17 averaging provisions for the annual standard.

18 The 24-hour standard. In this

19 first draft, we have not considered

20 alternative forms of the 24-hour standard, and

21 we have discussed level, just in conjunction

22 with the current form, which is a 98

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1 percentile form.

2 We expect to conduct additional

3 air quality analysis to inform the second

4 draft policy assessment, to better understand

5 the peak to mean ambient concentrations of

6 PM2.5.

7 For level, we look at both the

8 evidence and risk-based considerations to

9 inform a range of levels that we feel is

10 supported by the evidence and also provided

11 evidence from the risk-based considerations to

12 provide protection for both long and short

13 term exposures.

14 I will note again that in the

15 evidence based considerations, here we are

16 looking again at the air quality data, not

17 only that reported in the epi studies, but

18 also the additional information that we have

19 gathered from study authors, as well as

20 additional analyses that we have done to

21 better understand the air quality

22 distributions in the areas where the epi

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1 studies were conducted.

2 Again, we look at information we

3 have on susceptible populations to better

4 understand the impacts in those particular

5 populations. From a risk-based consideration,

6 we look at the nature, the magnitude, and

7 uncertainties of the long term and short term

8 exposure related risks related to simulations

9 of alternative suites of standards. That is

10 what is contained in the alternative suites

11 that are currently contained in a second draft

12 risk assessment.

13 More importantly, we look again at

14 the roles of the annual and 24-hour standards

15 and how they work together to provide public

16 health protection.

17 Lastly, we integrate these two

18 approaches into informing our conclusions for

19 alternative standards that we believe right

20 now are supported by the current evidence and

21 the risk-based information.

22 DR. JENKINS: Thanks, Beth. I am
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1 going to talk through really quickly an

2 overview of Chapter 3, which --

3 DR. STALLWORTH: Can you introduce

4 yourself?

5 DR. JENKINS: Oh, sorry. I am

6 Scott Jenkins, and I am the primary author on

7 Chapter 3, which is the primary standard for

8 thoracic coarse particles.

9 So similar to the organization of

10 Chapter 2 that Beth just got through walking

11 through, Chapter 3 is organized around a

12 series of policy relevant questions. 

13 We deal first with the adequacy of

14 the current standard, and I will just remind

15 you that, in the case of thoracic coarse

16 particles, we have a 24-hour PM10 standard,

17 which is meant to protect against exposures to

18 thoracic coarse particles.

19 So in considering this standard

20 and potential alternative standards for

21 protecting against thoracic coarse particles,

22 we walk through first the adequacy, and then

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1 on the next slide I will talk about potential

2 alternative standards in terms of the elements

3 of the standard, the indicator, averaging

4 time, form, and level, just as Beth did.

5 So first in considering adequacy,

6 there are two main issues that we dealt with

7 with regard to the adequacy of the current

8 PM10 standard. That is, first, the

9 appropriateness of maintaining a standard to

10 protect against effects associated with

11 exposures to thoracic coarse particles, and

12 second is the adequacy of the protection --

13 public health protection that is actually

14 provided by the current 24-hour PM10 standard.

15 So in addressing these two

16 questions, we walk through the available

17 scientific evidence, and so I will point out

18 here, as you are all aware, we didn't do a

19 quantitative assessment of risks for thoracic

20 coarse particles. So here we are relying on

21 the evidence base considerations in

22 considering the standard.

Page 36

1 So we looked at the evidence that

2 was available in the last review, at evidence

3 that has become available since the last

4 review, and that includes, as you are well

5 aware, a number of new epidemiologic studies,

6 multi-city studies in the U.S. and Canada and

7 Europe, studies that have been conducted in a

8 lot of different locations, some of the

9 studies that have looked at confounding by co10 pollutants. So there are a number of new

11 studies that are available that can inform

12 decisions on the adequacy of the PM10

13 standard.

14 Chapter 3 has a really limited

15 discussion of susceptible populations. In

16 large part, we refer back to Chapter 2, the

17 discussion in Chapter 2, and back to the ISA. 

18 So we don't repeat everything that is in

19 Chapter 2 on susceptible populations.

20 In considering the adequacy of the

21 level of protection provided by the PM10

22 standard, we do bring in PM10 air quality data

Page 37

1 from epi study locations. 

2 So here what we are talking about

3 is we look at the epi study -- or the study

4 locations where epidemiologic studies have

5 reported positive and statistically

6 significant associations between PM10-2.5 and

7 mortality or morbidity, and we look at whether

8 the PM10 concentrations in those locations

9 were above or below the concentrations that

10 are permitted by the current PM10 standard, so

11 an assessment of whether the current PM10

12 standard is providing adequate public health

13 protection against effects associated with

14 thoracic coarse particles.

15 Then important for the thoracic

16 coarse particle standard is the consideration

17 of the uncertainties, and these include

18 uncertainties due to limitations in the

19 monitoring network, uncertainties due to the

20 limited number of co-pollutant studies that

21 have been conducted, the limited nature of the

22 experimental supporting evidence.
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1 So that when you look at all of

2 this evidence together with the air quality

3 information, what this part of Chapter 3

4 presents is basically different ways of

5 considering the evidence and its associated

6 uncertainties and how those different

7 approaches to considering the evidence and

8 uncertainties could lead you to different

9 decisions on the adequacy of the current

10 standard.

11 As Karen mentioned, we are

12 obviously looking for feedback on the

13 approaches that we -- the considerations that

14 we have laid out, as well as the potential

15 conclusions that you reached.

16 So in terms of laying out

17 potential alternative standards for thoracic

18 coarse particles, as I mentioned, it is broken

19 down -- Chapter 3 is broken down into

20 discussion of indicator, averaging time, level

21 and form.

22 Indicator deserves some special

Page 39

1 mention here because currently, as I

2 mentioned, we have a PM10 indicator, and of

3 course, PM10 includes both thoracic coarse 

4 particles and fine particles, and so a

5 consequence of that is that, for a PM10

6 standard, it is going to allow lower

7 concentrations of thoracic coarse particles in

8 areas with high fine particle concentrations

9 than in areas with low fine particle

10 concentrations.

11 This tends to correlate with lower

12 thoracic coarse particle concentrations being

13 allowed in urban areas than rural areas, and

14 in the last review that was judged to be

15 appropriate. So what we lay out in the

16 indicator section is really a consideration of

17 the available evidence that reconsiders this

18 issue. 

19 Does it remain appropriate to have

20 a PM10 standard that essentially allows lower

21 concentrations of thoracic coarse particles in

22 urban areas than in non-urban or rural areas,

Page 40

1 while at the same time providing some measure

2 of protection against all thoracic coarse 

3 particles? So that is the indicator

4 discussion.

5 With regard to averaging time, we

6 focused really in on the 24-hour averaging

7 time here. So if you recall back to the ISA,

8 the ISA reached conclusions that there wasn't

9 enough evidence to draw conclusions regarding

10 the relationship between long term exposures

11 to thoracic coarse particles and adverse

12 health effects, and with regard to short term

13 the evidence was suggestive, concluded to be

14 suggestive of a causal relationship. 

15 So we focused in on short term

16 exposures, effects associated with short term

17 exposures, and specifically the vast majority

18 of the evidence, specifically the epi

19 evidence, is using 24-hour average thoracic

20 coarse particle concentrations.

21 There are a couple of controlled

22 human exposure studies that look at around

Page 41

1 two-hour exposure time frames, but we focused

2 in on this 24-hour averaging time here in that

3 discussion.

4 Now one thing that is different

5 from what Beth talked about for Chapter 2 is

6 that, with the level and form discussion in

7 Chapter 3 we haven't presented or analyzed

8 specific ranges of alternative levels and

9 forms at this point. So what we have is a

10 discussion of the approach we plan to take for

11 the second draft policy assessment. 

12 We do have in the form discussion

13 some considerations related to -- general

14 considerations with regard to a short term

15 standard that lead us to essentially

16 emphasizing a 98 percentile form as providing

17 a balance between limiting peak concentrations

18 and providing some regulatory stability.

19 So we have some general discussion

20 on form there, and with level we lay out the

21 general approach that we would identify ranges

22 of potential alternative levels using health
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1 studies, the epidemiologic studies. We could

2 lay that out in the second draft in terms of

3 either alternative ranges of PM10 standard

4 levels or PM10-2.5 standard levels or

5 potentially both. 

6 What we do in the second draft

7 assessment is going to depend, to some extent,

8 on how our thinking is refined between now and

9 then on the issue of indicator, obviously, and

10 that is going to be, obviously, informed by

11 feedback that we receive on the first draft

12 policy assessment.

13 So I think that Karen's point is

14 well made, that where we go from here is going

15 to depend to a large extent on what kind of

16 feedback we receive on this first draft

17 assessment.

18 So that is all I have on Chapter

19 3.

20 DR. MARTIN: That completed what

21 we wanted to say with regard to overview on

22 the policy assessment, and if there aren't any

Page 43

1 questions on that, then perhaps we should move

2 right into opening presentation on the risk

3 assessment.

4 CHAIRMAN SAMET: Well, I think

5 that is what we should do, probably. I think

6 we all received the document on Monday. There

7 is time set aside tomorrow for discussion.

8 We have just received the charge

9 questions on the policy assessment, and I

10 think we should probably reserve discussion

11 for tomorrow, and I think we will be probably

12 better informed and ready to do that.

13 I will say, I think I read most of

14 it. It is a long way from the West Coast to

15 the East Coast. 

16 DR. MARTIN: You will note that

17 the word draft is on top of those charge

18 questions. We thought, since we had the

19 opportunity to have some conversation with you

20 about them here that we would leave open those

21 questions and refine them, if appropriate,

22 following that discussion.

Page 44

1 CHAIRMAN SAMET: Sure. And I

2 think we should have, hopefully, ample time to

3 discuss the documents. Is that a hand? 

4 Sverre?

5 DR. VEDAL: Yes. I just wanted to

6 ask a clarifying question on the coarse

7 standard and see if I understood the point

8 right about using a PM10 standard to cover

9 coarse or a specific coarse standard in the

10 urban versus non-urban sort of setting.

11 I think I understood that, in

12 essence, a PM10 standard really tightens the

13 coarse standard in essence in urban areas

14 versus non-urban areas. Is that correct?

15 DR. JENKINS: That is right, and I

16 did sort of gloss over that issue here just in

17 the interest of time, but there is a pretty

18 extensive discussion of the rationale that was

19 used to justify that PM10 standard in the last

20 review, and it is in this policy assessment

21 that you have. But you are correct in your

22 basic premise.

Page 45

1 DR. VEDAL: And the underlying

2 notion there is in favor then of a specific

3 coarse standard then to avoid that

4 irregularity?

5 DR. JENKINS: Well, that is an

6 open question. So one of the questions is,

7 does it remain appropriate to retain a

8 standard or maintain a standard that allows

9 that sort of difference in thoracic coarse

10 particle concentrations in urban versus non11 urban environments.

12 That will depend on where the

13 evidence pushes us. So that is an open

14 question.

15 CHAIRMAN SAMET: Joe?

16 DR. BRAIN: I have an adjacent

17 question, which really is on the topic of what

18 is our purview and what are we allowed to

19 comment on because, again, you had talked

20 about alternative standards, and I guess,

21 Karen, you even said, you know, is continuing

22 the PM2.5 justified.
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1 So I guess my question is are we

2 limited to the data that is available and what

3 is in the ISA or are we also allowed to think

4 of what kind of sampling system, what kind of

5 data would we like 20 years from now?

6 CHAIRMAN SAMET: Well, the

7 question of monitoring, which might be called

8 for in relationship to any standard, I think,

9 is something that would be addressed, in

10 essence, by a subgroup. So I am not sure we

11 need to go there today, Joe, but I agree,

12 there's lots of issues that get opened up, and

13 I was trying not to get them opened up right

14 now, I think.

15 DR. BRAIN: We will never really

16 be able to consider different alternative

17 standards unless we begin to get the kind of

18 data we need to support those alternative

19 standards. So we are sort of stuck in this

20 rut with PM-10.

21 CHAIRMAN SAMET: Well, we just

22 went down this discussion, you remember, with

Page 47

1 NO2, in fact, and there the standard will be

2 forcing the monitoring. So, Karen, is there

3 a directive at this point?

4 DR. MARTIN: Yes. I just wanted

5 to say that you will find on the first or

6 second page of the policy assessment a

7 paragraph that notes that there are monitoring

8 issues that are related to our consideration

9 of indicator, in particular, and that the

10 second draft policy assessment will contain

11 some additional information to help in

12 understanding those linkages. So it is sort

13 of a promise of things to come with regard to

14 going down that path a little bit more.

15 CHAIRMAN SAMET: Is that a person

16 with a hand raise?

17 DR. SPEIZER: Yes. Worrying a

18 little bit about getting on the wrong side of

19 you at this point. But is there any

20 possibility that there can be consideration of

21 regional standards for the coarse particles or

22 does the law just prevent us from doing that?

Page 48

1 DR. MARTIN: The standards we are

2 talking about are national standards. So we

3 are not in the business of using the mandate

4 of the Clean Air Act for setting national

5 ambient quality standards to set regional

6 standards.

7 Having said that, I would note

8 that, in the context of other NAAQS reviews,

9 in particular the review ongoing with regard

10 to secondary standards for nitrogen and

11 sulphur, NOx-SOx secondary standards, we are

12 looking at a standard that would incorporate

13 the complexities of recognizing that differing

14 ecosystems respond to the same deposition of

15 nitrogen and sulphur in different ways, and

16 how do you build that type of complexity? 

17 How do you build in spatially

18 varying elements into the definition of a

19 standard to allow for a national standard that

20 incorporates the scientific realities of

21 differing impacts in different places?

22 So it is not beyond the realm of

Page 49

1 reason that one can incorporate those factors

2 in, but in the end we still need to end up

3 with a nationally defined standard.

4 CHAIRMAN SAMET: Actually, I am

5 going to cut this off, Bob. I'm sorry. I am

6 actually reminded, Rogene, of Governor Bruce

7 King of New Mexico recently died, who talked

8 about opening the box of Pandora's, and I

9 don't want to open it now, because I think I

10 just want to get us through our business for

11 the day before we -- Bob, we will definitely

12 have a chance to come back. I just see that

13 the bad behavior that originated with Sverre

14 will just continue, and we will be here off

15 target forever. So, Frank, you are on my

16 wrong side.

17 Let's see. So why don't we go on

18 -- sorry -- to deal with the quantitative

19 health risk assessment. I am sure we are

20 going to have plenty of time to come back and

21 discuss the policy assessment. I think,

22 again, everybody has tonight perhaps to get a
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1 little more familiar with what is in the

2 charge questions.

3 DR. STALLWORTH: Let me also ask

4 if anyone is on the phone, and can you hear

5 us? 

6 MS. NUGENT: Holly, this is Angela

7 Nugent calling in at your request, just to let

8 you know that the audio is fine, at least for

9 me.

10 DR. STALLWORTH: Thank you. 

11 MR. CORRALES: The sound quality

12 has been good at times and very bad at times. 

13 It helps if the microphone is closer.

14 DR. STALLWORTH: Who was that

15 speaking?

16 MR. CORRALES: This is Mark

17 Corrales in OPI. 

18 DR. STALLWORTH: Okay. Could you

19 spell your name for the record, please?

20 MR. CORRALES: C-o-r-r-a-l-e-s.

21 DR. STALLWORTH: Thank you. Do we

22 have any public comments?

Page 51

1 CHAIRMAN SAMET: We are actually -

2 - we are going to do the health risk

3 assessment. Then we will come to the public

4 comments.

5 Okay, so let me turn then back to

6 Zach.

7 DR. PEKAR: Thank you. I wanted

8 to -- I am Zach Pekar, and I think everybody

9 knows that I have been the lead on the risk

10 analysis and for the second draft here. So I

11 wanted to start just by thanking folks for

12 taking the time to, I think, already give it

13 a pretty intensive read and review. 

14 The preliminary comments that we

15 have gotten clearly reflected a lot of thought

16 from folks, and I really wanted to thank you

17 all for that.

18 So my goal really right here is,

19 now we have talked about before with the first

20 draft, is not to provide an exhaustive

21 detailed technical overview of the analysis,

22 but really first just to highlight some of 

Page 52

1 the key enhancements and changes that we have

2 made since the first draft, and then to walk

3 through the charge questions very quickly,

4 just to make sure that we are all sort of

5 grounded in those before we start the more

6 detailed discussions later on.

7 I managed to catch my kids' cold

8 finally. So if I am sniffling up here, I will

9 try to do that away from the mic.

10 So just beginning with a quick

11 overview of the enhancements, one of the main

12 things that we have done is, I think, in

13 response to what we felt we needed to do, but

14 also really also responding to suggestions

15 from CASAC. 

16 We have included now this

17 integrative Chapter 6, which is really our

18 effort to pull together the risk estimates

19 from the urban study areas, together with

20 consideration for the qualitative and

21 quantitative treatment of uncertainty and

22 variability and the National Skill Analyses,

Page 53

1 pull all that together into one chapter that

2 would sort of bridge the risk assessment to

3 the policy analysis. That is a major

4 modification to this version of the document.

5 We have also included expanded

6 discussion of our rationale for a number of

7 points, technical points in the analysis,

8 including what Scott talked about, which was

9 our reasoning for not conducting a

10 quantitative assessment of risk for thoracic

11 coarse, providing enhanced explanation for our

12 selection of modeling elements for the core

13 risk assessment, and once again we completed

14 a set of core risk estimates which are

15 estimates that we have greater overall

16 confidence in, and those are supplemented by

17 the sensitivity analysis results which we also

18 have confidence in, and together those two

19 sets of estimates, hopefully, provide some

20 treatment of uncertainty.

21 Then we have also just given a

22 little more explanation for how we
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1 qualitatively assessed uncertainty and

2 variability in the analysis, the procedure

3 that we used for that.

4 The sensitivity analysis: The

5 quantitative sensitivity analysis has also

6 been expanded. We have now included

7 consideration for lag effects in the Bell

8 study. That was a suggestion that was made,

9 I think, by CASAC, and we have done that.

10 We have also compared and

11 contrasted the results of the sensitivity

12 analysis with the confidence intervals that we

13 get form considering the statistical fit of

14 the concentration response function. 

15 So those were two quantitative

16 pieces of information we had presented last

17 time, but we hadn't compared and contrasted

18 those. So we have done that now.

19 I think another important

20 enhancement to this analysis is the inclusion

21 of consideration for peak shaving. So in the

22 past when we were simulating alternate

Page 55

1 standard levels, we have to simulate the

2 reduction of -- the spatial pattern of

3 reduction in the PM2.5; monitor levels.

4 We used proportional rollback in

5 the past. We also considered a hybrid

6 rollback, which sort of was a fusion of a more

7 localized reduction and a more regional

8 reduction. Now for this version, we have also

9 included peak shaving, which is really a

10 focused look at a very localized reduction in

11 the pattern of ambient PM2.5 under alternate

12 standard levels.

13 I am not going to get into a lot

14 of detail on that second bullet. Essentially,

15 time has been so intense with this that, when

16 we looked at peak shaving, we couldn't

17 actually run -- rerun the full risk assessment

18 with peak shaving rollback.

19 What we had to do was look at

20 composite monitor averages and compare

21 composite monitor averages, which is sort of

22 the annual average value for a study area once

Page 56

1 you have rolled back the levels.

2 If you compare a composite monitor

3 annual average that you got for peak shaving

4 to what you got, for instance, from

5 proportional rollback or the hybrid rollback,

6 you could compare those to an essentially look

7 at how long term mortality will differ,

8 because long term mortality will differ,

9 because long term mortality reductions are

10 really tied to reductions in the annual

11 average at the composite monitor.

12 So all the second bullet -- and I

13 think our explanation wasn't so clear on this,

14 and I am seeing some looks. Maybe we can talk

15 about this later.

16 I can give a little more

17 clarification, but essentially all we mean by

18 this is that, rather than generating full

19 quantitative long term mortality risk

20 estimates with the peak shaving rollbacks, we

21 stopped short of that and compared and

22 contrasted the degree of reduction in the

Page 57

1 composite annual average PM2.5 levels as a way

2 of looking at what we think would happen with

3 mortality, long term mortality. I can provide

4 additional discussion of that, if we need.

5 Then the third bullet: For this

6 analysis, we provided, I think, a more

7 expanded or more intense consideration of the

8 sensitivity analysis results for informing our

9 overall confidence in the core risk estimates. 

10 So when we considered the results of the

11 sensitivity analysis in that integrative

12 Chapter 6, how can we really use those to make

13 more solid statements about our overall

14 confidence in the risk estimates? So we have

15 done that.

16 Then finally, in number 4, for the

17 integrative discussion chapter in particular,

18 we have -- Beth was alluding to this, too --

19 we have really talked more about the way the

20 24-hour -- Excuse me. I am getting ahead of

21 myself here. You can consider the pattern,

22 the relationship between design values, 24-
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1 hour in annual design values, at the 15 urban

2 study areas and contrast the way that

3 relationship between design values in our

4 study areas compares to the pattern of design

5 values you see across the broader set of urban

6 areas in the U.S. 

7 That allows us to get a sense for

8 how representative our 15 urban study areas

9 are of the broader set of urban areas in the

10 U.S. So it was another way of helping us to

11 interpret our risk estimates and put them in

12 a national context.

13 So now moving into just an

14 overview quickly of the charge questions, and

15 the charges questions are designed to focus on

16 changes, often, and the enhancements that we

17 have done in the risk assessment. 

18 So as I discuss these charge

19 questions, you are going to see that the

20 points I just made are largely repeated here. 

21 So I will move through some of these fairly

22 quickly.

Page 59

1 So we begin with Chapter 3, which

2 is the methods used in conducting the urban

3 study area risk assessment. So one of the

4 things we discussed is the inclusion of this 

5 peak shaving rollback approach and the use of

6 the composite monitors as a surrogate for

7 looking at differences in the long term

8 mortality. It is the point I just made.

9 So we were simply interested in

10 the Panel's feedback on inclusion of this peak

11 shaving rollback method.

12 Selection of model inputs: As I

13 mentioned, we provided a little more

14 discussion of how we selected our core risk

15 assessment, how we designed the core risk

16 assessment, and just getting some feedback

17 from the Panel on that.

18 In terms of addressing uncertainty

19 and variability, as I said, we have clarified

20 the process for how we qualitatively assess

21 uncertainty and variability. We have included

22 coverage for some additional sources of

Page 60

1 variability and uncertainty. 

2 I mentioned the lag issue. I

3 think including peak shaving is actually

4 looking at a critical source of variability,

5 variability specifically in the way urban

6 areas might respond in terms of reductions,

7 the pattern of reductions in ambient 2.5

8 monitoring levels. I guess that sort of

9 covers that.

10 Then in Chapter 4 when we talk

11 about summarizing the urban case study risk

12 estimates, the results, one of the charge

13 questions spoke to the use of the sensitivity

14 analysis results and informing consideration

15 of uncertainty in the core risk estimates, and

16 then considering the interplay of the design

17 values across the study areas, and

18 interpreting risk estimates.

19 so one of the things we realized

20 is that, when we look at the pattern of risk

21 reductions in the 15 urban study areas, you

22 start to have a lot better understanding of

Page 61

1 what is going on if you really look in detail

2 at the interplay between the 24-hour and the

3 annual design values at each of the 15 urban

4 study areas.

5 Some study areas have very peaky

6 ambient 2.5 levels. What I mean by that is

7 that the ratio of the max, of the 98

8 percentile PM2.5 level for the average PM2.5

9 level may be very, very wide, and the way that

10 an alternate standard level may affect risk is

11 really linked to that interplay between the

12 design values.

13 So we found that we were able to

14 sort of classify and see a lot of rational

15 explanation for the patterns of risk

16 reductions that we saw, if we really looked in

17 more detail at that relationship between the

18 24-hour and the annual design values. 

19 That is featured pretty

20 prominently in that integrative Chapter 6. So

21 just getting some feedback on our observations

22 and how we thought those factors played
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1 together in helping to explain the pattern of

2 risk reductions that we saw.

3 Then finally, in integrative

4 Chapter 6, because this chapter is new and I

5 think everybody would agree that it is pretty

6 important, most of the -- a lot of the charge

7 questions really focused on this integrative

8 Chapter. So let; me just walk through these

9 very quickly.

10 First of all, in the integrative

11 chapter, we laid out a set of policy related

12 questions that we wanted to address in that

13 integrative chapter. So one of the key

14 questions is have we missed any of the key

15 policy related questions?

16 Obviously, that is a question also

17 for the policy analysis. Have we missed

18 something in terms of interpreting the risk

19 estimates in the context of thinking about the

20 NAAQS decision making process?

21 Considering the range of factors

22 and interpreting the core risk estimates: so

Page 63

1 we wanted to make sure we understood what we

2 saw happening with the risk estimates, and 

3 particularly the degree of risk reduction we

4 saw across the different urban study areas. 

5 So we considered a number of different factors

6 that I have already mentioned, to a certain

7 extent: the interplay of the annual and 24-

8 our design values, the peakiness of the PM2.5

9 distributions, the way those two factors

10 interplay, and then finally the role of

11 different rollback procedures.

12 So when we conduced a peak shaving

13 rollback versus a proportional rollback, we

14 saw that that could have a marked impact on

15 the degree of risk reduction, and we tried to

16 provide some explanation for why that was.

17 Then assessment of overall

18 confidence: So we attempted to make a pretty

19 clear statement about our degree of confidence

20 in the core risk estimates, informed by the

21 sensitivity analysis results as well as the

22 qualitative treatment of uncertainty and

Page 64

1 variability that we had done. So we certainly

2 would like some feedback from the Panel

3 members on that.

4 Then we conducted a number of

5 supplemental national-scale analyses. Two of

6 these, we have already talked about, I think,

7 in the last review of the first draft. So I

8 won't go into a lot of detail.

9 We conducted a national-scale

10 mortality analysis which had two roles. It

11 provided a mortality estimate, and we have ad

12 some discussion about that. It also allowed

13 us to see how our 15 urban study areas

14 compared to the national distribution of risk. 

15 So did our study areas fall toward the

16 national distribution? Did they fall broadly

17 across the distribution? 

18 It was useful in terms of getting

19 a perspective for the representativeness of

20 our study areas, which would be a nice little

21 link into the second analysis, which was this

22 representative analysis where we compared and

Page 65

1 contrasted our urban study areas to the

2 broader national distribution for a range of

3 a variety of risk related factors, basically

4 on incidence rates and so forth. I think we

5 talked about that in some detail last time.

6 Then I think number 3 is new for

7 this analysis. One thing we did is, given the

8 importance of that 24-hour -- the 24-hour and

9 annual design values in explaining patterns of

10 risk reductions across the 15 urban study

11 areas, we said, well, what if we looked at the

12 interaction and the relationship or the

13 pattern of 24-hour and annual design values

14 across the broader set of 250-some larger --

15 256, I think -- urban study areas that we

16 have. How would our 15 areas compare to that

17 broader pattern?

18 There are a series of scatter

19 diagrams that are presented at the end of

20 Chapter 4 that gets at this issue, and I think

21 that that was helpful in informing what we

22 think -- how we think our 15 urban study areas
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1 fall more broadly into the urban distribution

2 of -- sorry, national distribution of urban

3 areas.

4 Then key observations: So we

5 really had a number of key observations which

6 we provide at the end of Chapter 6 in bulleted

7 form, but I think two that we really wanted to

8 highlight. 

9 One is that this -- In looking at

10 the relationship between 24-hour and annual,

11 alternative annual and alternative 24-hour

12 standards, one observation we made is that,

13 generally, the annual standard levels produce

14 a more uniform degree of public health

15 protection.

16 When you set an annual standard in

17 terms of long term mortality, in particular,

18 but also short term endpoints, you see a

19 consistent -- a more consistent level of

20 protection, because you are fixing -- you are

21 achieving a more consistent level of reduction

22 in annual average PM2.5 levels, which are

Page 67

1 highly correlated, clearly, with reductions in

2 long term mortality, but even with reductions

3 in short term mortality and morbidity. We can

4 talk more about that.

5 The other interesting point is

6 that often, while more stringent 24-hour

7 standard levels would produce an additional

8 risk reduction, often that happens because you

9 have driven the annual average PM2.5 levels

10 very, very low, down to seven, eight, nine,

11 fairly low levels; whereas, if you have a

12 fixed annual standard, you are looking at the

13 annual levels typically at that level, because

14 that is where you have reduced them down to.

15 So an annual -- alternative annual

16 standard of 12, if you having risk reductions,

17 it is because you have got levels down to 12. 

18 If you push the 24-hour standard down, for

19 instance, to 25, you will see that often you

20 have annual average levels, if proportional

21 reductions have gone very low. This may be

22 something we need to talk about in more

Page 68

1 detail.

2 The final point, I think, is

3 something we are very interested in. We

4 thought that the risk assessment suggested

5 that there could be additional risk-benefit

6 from considering standards, annual standard

7 levels below 12.

8 In the comments from a number of

9 panel members, we got some -- Those Panel

10 members voiced concerns about uncertainty in

11 looking at alternative annual standard levels

12 below 12. 

13 Of course, that is a point that is

14 very interesting to us, and I think one

15 question we had is it would be very

16 informative for us to have a really good

17 discussion on what is meant by that

18 uncertainty, how broad that feeling is felt,

19 and is it that there is a concern regarding

20 the -- whether people have concern with

21 confidence in adverse health effects occurring

22 below 12 or whether it is simply that there is

Page 69

1 uncertainty in the form of the concentration

2 response function below 12. 

3 These are, obviously, two

4 different takes on that issue, and I think

5 just a little more discussion on that and the

6 rationale behind the Panel's perspectives

7 would be very useful to us.

8 Then the final slide -- and there

9 is not a lot of time; so I won't spend a lot

10 of time on this. But because I think time is

11 so tight and because we thought that the

12 findings of the core risk estimates that we

13 had seen suggested that looking at alternative

14 annual standard levels below 12 might be of

15 interest, we went ahead and did some very

16 preliminary simulations of an alternative

17 annual standard level of 10, just to see what

18 that seemed to do in terms of additional risk19 benefit.

20 I want to just reiterate that this

21 is a preliminary run, and that we are very

22 interested in the perspectives that the Panel
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1 has on uncertainty associated with this kind

2 of simulation, but just to give a quick

3 overview of some of the results that we saw

4 with this.

5 So what this table does is it

6 compares risk under the 12 -- Let me just stop

7 for a second. This is in terms of IHD -- long

8 term exposure related IHD mortality. So that

9 is what we are talking about here.

10 What it does is it says, if we had

11 risks -- If we had run risks for the 1235

12 scenario -- so that is an alternative annual

13 level of 12; so the lowest alternative annual

14 level we looked at, paired with the current

15 24-hour standard, what additional percentage

16 reduction in risk -- so what is the percentage

17 of additional risk reduction we would see by

18 reducing -- first, if we looked at reducing

19 the 24-hour standard down to 25.

20 So if we had kept the 12 and just

21 reduced the 25, so driven the 24-hour standard

22 level down to 25, what is the percentage

Page 71

1 reduction in risk that we would see across the

2 study areas?

3 Alternatively, if we had looked at

4 that alternate annual standard of 10, if we

5 had pushed the annual standard level down to

6 10, what is the degree of risk reduction that

7 we would see? So this is comparing two

8 different ways of reducing risk below the

9 standard level of a 12-35 combination.

10 So let's just -- It is always

11 better, I think, if I take one row and explain

12 what is going on here. 

13 So if we look at Dallas, Texas, we

14 see that, relative to this under the 12-35 --

15 so this is already an alternate standard level

16 -- if we look at 12-25, so we drove the daily

17 down to 25, we would see no additional

18 reduction in risk, and this is because Dallas

19 has a very -- does not have a very peaky PM2.5

20 level, meaning it is 98 percent -- It is daily

21 design value, and its annual design values are

22 not terribly different -- The max to average

Page 72

1 peak ratio is not very wide.

2 What that means is reducing the

3 24-hour standard really doesn't do anything to

4 its risk reductions, if you assume a

5 proportional reduction when you reduce the 24-

6 hour.

7 Conversely, for Dallas if you

8 reduce the annual standard level to 10, you do

9 see -- and this is pretty dark -- You do see

10 a notable reduction in risk at 34 percent, and

11 I would add that we are talking about annual

12 average PM2.5 levels at the 12-25 level of 12,

13 meaning we are talking about annual average

14 PM2.5 levels that are around 12 with this

15 simulation.

16 Now let's jump down to sort of the

17 opposite side of what we saw, which is looking

18 down at Salt Lake City. Salt Lake City has an

19 extremely peaky PM2.5 level. What I mean by

20 that is it has very low annual average PM2.5

21 and very high peak 98 percentile 24-hour

22 design values.

Page 73

1 What that means is a 24-hour

2 standard is going to have a much greater

3 effect on a place like Salt Lake City than it

4 is on Dallas, and we see that, that in this

5 case if you apply an alternate 24-hour

6 standard of 25, kind of a mouthful, you have

7 essentially -- if you assume proportional

8 reduction -- So in getting and achieving that

9 24-hour standard, you are pushing the annual

10 standard down also. So that is a big

11 assumption.

12 You end up pushing the annual

13 average down to 5.7, which is right around

14 that lowest measured level that we assessed

15 risk at. So we only assessed long term risk

16 down to 5.8. So essentially, you reduce all

17 of your long term mortality to zero, given the

18 range down to which we are assessing risk.

19 The numbers here, I think, are not

20 necessarily so important. It is the fact that

21 this further illustrated the point we already

22 saw with the simulations we had done, the
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1 alternate standard levels we had done, which

2 is that targeting the annual standard level

3 can have substantial risk reductions, and

4 those had to be associated with annual average

5 levels that are at a level where you have

6 greater confidence in making risk estimates

7 about. But if we look at an alternate 24-hour

8 standard level, in this case of 25, the lowest

9 level we have looked at, you can see very,

10 very substantial additional risk reduction.

11 You can see this down here with

12 these urban study areas, Fresno, Tacoma, West

13 coast areas with very high daily levels and

14 very -- and relatively lower annual average

15 levels, but those risk reductions are

16 associated with annual average PM2.5 levels

17 that are at a level where we would have,

18 obviously, greater concern about making risk

19 estimates, so greater uncertainty in making

20 risk projections.

21 That is just another -- This is

22 sort of reiterating that observation we made.

Page 75

1 Go back for a second, and then I

2 will be done.

3 This observation up here that the

4 annual standard level seemed to give us a

5 greater -- give us risk reductions, but we

6 have a greater degree of confidence in

7 asserting those magnitudes of risk reductions

8 relative to the 24.

9 So that was all I wanted to say. 

10 Thank you.

11 CHAIRMAN SAMET: Okay, thank you,

12 Zach. So we are going to go, obviously, in

13 greater detail when we go through the charge

14 questions, but are there clarifying questions

15 related to this presentation? Okay, good. 

16 Thank you then.

17 We will move on then to public

18 comments, and I think we have one public

19 commenter, David, representing API.

20 DR. SAX: Hello.

21 CHAIRMAN SAMET: It is on. Just

22 say your name, please.

Page 76

1 DR. SAX: Good morning. I see a

2 lot of familiar faces, the Harvard cohort over

3 there.

4 I am Sonja Sax, and thank you for

5 the opportunity to speak today. I am from

6 Gradient, and I am commenting on behalf of

7 American Petroleum Institute.

8 The second draft risk assessment

9 has not changed substantially. There have

10 been some additions, but I will basically

11 summarize some of the major concerns that we

12 discussed in great detail in comments on the

13 original draft.

14 In the last PM NAAQS review, the

15 U.S. EPA Administrator actually concluded that

16 the PM RA at the time was not sufficiently

17 robust to use for determining the level of the

18 PM standard, and many of the issues associated

19 with the previous RA were related to the large

20 uncertainties and variability inherent in the

21 epidemiological studies used for the CR

22 functions.

Page 77

1 After reviewing the current draft

2 RA, I conclude that these issues have not been

3 resolved, and the RA should not be used to

4 establish any ranges in the policy assessment,

5 and specifically, some of the issues that have

6 carried over from the previous risk assessment

7 include consideration of health endpoints that

8 are less than causal, that still significant

9 uncertainties and variability in the epi

10 studies used to define the CR functions -- for

11 example, confounding measurement error and

12 heterogeneity in the PM2.5 effects, and then

13 lastly, the generation of multiple very

14 subjective point estimates with no best

15 estimate and a null effect that really cannot

16 be ruled out.

17 The health endpoints considered in

18 the RA were those that were determined to be

19 causal and likely causal in the ISA. However,

20 really, the framework that was used was not

21 consistently applied across the epi studies,

22 and the uncertainties were often understated. 
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1 So, really, it is inappropriate to use

2 anything that is less than causal.

3 For example, in the RA lung cancer

4 was considered, even though this endpoint is

5 really classified s being suggestive, and

6 several significant uncertainties and

7 variabilities are associated with the

8 epidemiological studies that are the basis of

9 the CR function.

10 Although it may be appropriate to

11 use the latest data that we have, there is

12 really little consistency in results across

13 studies, and this really raises a lot of

14 concern.

15 Some of the major uncertainty,

16 again confounding factors, heterogeneity of

17 PM2.5, and measurement error, still have only

18 been addressed in a very qualitative way. In

19 fact, the sensitivity analysis highlights a

20 lot of this uncertainty, particularly for

21 short term effects, and brings into question

22 the utility of the RA.

Page 79

1 Also, the sensitivity analysis

2 gives us a bunch of point estimates without a

3 clear distribution. So what is the best

4 estimate?

5 The issue of confounding continues

6 to permeate, but has largely been ignored. 

7 For example, single pollutant models keep

8 being utilized, even though there is evidence

9 of confounding by a number of co-pollutants,

10 and these have been addressed in previous risk

11 assessments.

12 Between CD and between region

13 heterogeneity, I think, it is a very important

14 issue. That has also been ignored. Although

15 it was partially addressed in this risk

16 assessment, I think that really needs to be

17 considered.

18 The long risk estimates are even

19 more uncertain, because they are based on a

20 nationwide CR that then is applied to those

21 urban centers and do not reflect the

22 heterogeneity.

Page 80

1 Lastly, measurement error

2 continues to be an important source of bias,

3 particularly for these estimates of long term

4 exposure. 

5 In conclusion, the uncertainties

6 and variability apparent in the 2005 risk

7 assessment were not resolved in the current

8 risk assessment, and since U.S. EPA concluded

9 in the last risk assessment that it could not

10 base determining the level of the PM2.5

11 standard on the risk assessment, likewise the

12 current risk assessment should not be used to

13 inform the policy assessment.

14 Thank you very much.

15 CHAIRMAN SAMET: Thank you. 

16 Questions for our commenter? Good. Thank

17 you.

18 So the next item on the agenda is

19 now not break, but we will move on to charge

20 question 1. Ted, I think you are in the lead

21 on that one.

22 DR. RUSSELL: Yes.

Page 81

1 MS. SHPRENTZ: Excuse me, Jon. 

2 This is Debbie Shprentz. I also had public

3 comments.

4 CHAIRMAN SAMET: I'm sorry.

5 DR. STALLWORTH: Okay.

6 CHAIRMAN SAMET: Can you say your

7 name again?

8 MS. SHPRENTZ: Debbie Shprentz. 

9 CHAIRMAN SAMET: Okay, fine.

10 MS. SHPRENTZ: Yes. It is Debbie

11 Shprentz from the American Lung Association. 

12 Can you hear me?

13 CHAIRMAN SAMET: Yes, we can.

14 DR. STALLWORTH: We can hear you

15 well.

16 MS. SHPRENTZ: Well, thank you for

17 the opportunity. I just wanted to make some

18 brief comments on a couple of points about the

19 draft risk assessment.

20 One is we are very happy to see

21 EPA include for the first time the National

22 Assessment of Mortality Risks, and we believe
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1 that the studies that EPA has run the risk

2 functions from are the appropriate studies to

3 look at. 

4 Those are the major long term

5 cohort studies which have recently been

6 extended to cover longer exposure periods and

7 encompass a greater number of deaths. So EPA

8 comes up with a lower estimate based on the

9 Krewski 2009 study, and then a somewhat higher

10 estimate based on the ACS extended -- I'm

11 sorry, the six city extended study.

12 We think it is appropriate that

13 EPA has estimated risk down to the lowest

14 measured level in both of these studies, which

15 is 5.8 in the ACS study and 10 in the six city

16 study, and that is consistent with our

17 understanding that there is a linear

18 relationship between exposure and risk with no

19 clear threshold, which has been confirmed by

20 another extended analysis of the six city

21 study, the Schwartz et al. 2008 study.

22 EPA also looked at risk down to

Page 83

1 the policy relevant background level, and that

2 is consistent with EPA's approach in the

3 regulatory impact analysis. But we do feel

4 that -- you know, EPA asks should we be

5 evaluating risk below 12. 

6 I think, to a certain extent this

7 draft was sort of stuck somewhere in the last

8 review when the policy options that were on

9 the table in the last review, but in the

10 current review the ISA has evaluated a large

11 number of new long term studies, confirming

12 the relationship between PM exposure and

13 premature death, and these studies are

14 reporting the facts at lower concentrations

15 than previously studied.

16 You know, in their preliminary

17 comments, some of the members of the committee

18 seemed to indicate that there is more

19 uncertainty at lower concentration, but when

20 I look at the tables in the ISA and the

21 confidence intervals associated with various

22 risk estimates, I certainly don't see any kind

Page 84

1 of pattern suggesting that that would be the

2 case. So I don't see a clear justification

3 for that argument, based on the confidence

4 intervals in both the long term and the annual

5 average concentrations in the short term

6 studies.

7 So we certainly think it is

8 appropriate to, in the risk analysis, look at

9 lower concentrations that are consistent with

10 the lower measured levels in these studies. 

11 Certainly, it seems appropriate to look at 11

12 and 10 and perhaps even lower concentrations.

13 We also like to see the

14 exploration of the impacts of alternative

15 standard levels extend to the national

16 assessment as well as the 15 cities, because

17 we feel that this would be very informative

18 and would not take a lot of time and

19 resources, given that this is easily

20 accomplished through use of the BenMAP model.

21 In addition, it might be

22 informative to include other health endpoints

Page 85

1 in this national analysis, such as emergency

2 room visits, hospital admissions, et cetera.

3 That concludes my remarks. 

4 CHAIRMAN SAMET: Thank you,

5 Debbie. Questions for the commenter? Okay,

6 thanks.

7 I guess we haven't missed any

8 other public commenters, just to make sure?

9 So we are back, Ted, to charge

10 question 1. 

11 DR. RUSSELL: Thanks, Jon. And

12 did you want to do Questions A and B at the

13 same time? 

14 CHAIRMAN SAMET: Okay.

15 DR. RUSSELL: So the questions had

16 to do -- I am not sure if you got a copy of

17 the charge questions on -- No. I was

18 wondering if you could show them up there. 

19 That's fine.

20 As Zach presented, they have added

21 this peak shaving approach, and the question

22 was: Is this useful? I actually found it
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1 useful and interesting, and I thought it had -

2 - it was a reasonable way to show the impact

3 of what would happen in this case, which is a

4 nice lower bound.

5 I would say it could be better

6 motivated just what sort of control strategy,

7 where it might be applied, and I think you --

8 in terms of some of the different comments you

9 got back on this, that shows us that it would

10 really be good to know how this might be

11 pulled off. Is there a real control strategy

12 that would do this?

13 I will also say -- So, yes, it

14 would be nice to have that identified.

15 A general comment, and you saw

16 this from more than just myself, is that

17 whatever approach you have, it should be

18 provided mathematically, just so we can really

19 see what the equation is, because words get a

20 little muddled at times.

21 So if you could do that in the

22 appendices, that would be fine, and I also

Page 87

1 thought it might be nice to have an example,

2 just one or two cities, just to show the

3 difference and say, okay, this is really what

4 is happening.

5 Question B is -- They talk about

6 using comparisons of composite monitor annual

7 averages using the various approaches, and

8 they ask if that is reasonable to show the

9 variability.

10 My first comment here is that I

11 thought it would be better to have this all

12 motivated by how the current standards really

13 work in terms of the compositing and how you

14 do the annual averaging from the quarters, et

15 cetera, because that would have, I thought,

16 help motivate how you went about the whole

17 approach in this section; because I think if

18 you understand how the annual standard is done

19 and how compositing is done, that answers a

20 number of the questions. Without that, you

21 have to go and look at them to say, okay, how

22 does this align with current practice.

Page 88

1 Then in terms of how you do

2 replacing of missing values, I have written up

3 one of the approaches that I think that we

4 have used very profitably.

5 Bottom line is I wasn't really

6 comfortable with how you replace missing

7 values, in that I think that could lead to

8 biases. I think there's other ways that could

9 be done. I won't go into sort of the

10 mathematical approach that I might have

11 suggested. There's other ones that one could

12 also use.

13 So that part left me somewhat

14 uneasy, and again if you could provide the

15 mathematical equations, either within the text

16 or within the appendices, that would be

17 appreciated.

18 CHAIRMAN SAMET: Okay. Thanks. 

19 So, Phil?

20 DR. HOPKE: Yes, I agree that I

21 think there are problems with the approach to

22 imputing the missing values, and there are

Page 89

1 better ways of doing it, if you really think

2 you need to impute them in the first place.

3 The other thing I am very

4 uncomfortable with is peak shaving. I don't

5 really see that it is a practical approach in

6 terms of setting up a strategy. 

7 So the idea of distorting the

8 distributions by chopping the peaks off

9 doesn't impress me as something that is

10 reasonable and realistic to do, and I think it

11 just provides a false impression of what can

12 be potentially accomplished in terms of an

13 implementation strategy.

14 So I don't see where it provides

15 you with significant improved understanding of

16 the risks under various standard scenarios,

17 because I just don't see how you would achieve

18 in most practical cases anything that would,

19 in fact, shave those peaks off. If it were

20 that easy to shave them off, I suspect state

21 and local agencies would have done so long

22 ago. 
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1 DR. PEKAR: Could I just offer --

2 Not to interrupt, but I just want to offer a

3 point of clarification.

4 I think we had some discussion

5 here in writing this up about the language of

6 calling peak shaving. I think there is,

7 clearly, very understandable confusion about

8 what we did, and we didn't include as much

9 mathematical discussion, and when you combine

10 those two things -- So let me just be clear.

11 The way the peak shaving was done

12 is that, if you had an urban study area and

13 you had two monitors that exceeded the current

14 daily standard -- the 98 percentile three-year

15 average -- we would look at the degree, the

16 percentage to which that excedence -- the

17 percentage of that excedence. 

18 So let's say that -- That is the

19 wrong way to say it. Let's say that you had

20 a 25 percent reduction and the daily design

21 value to attain the daily standard at that

22 monitor. Okay? So instead of 35, it was at

Page 91

1 whatever that would be -- 42. 

2 We reduced the entire distribution

3 of daily values at that monitor by that

4 percentage. So it is not that we clipped the

5 top off. What we did is we shifted the whole

6 distribution down. I am not sure if that

7 clarifies.

8 DR. HOPKE: That is entirely

9 unclear. There is no way from reading the

10 document that we can infer that approach.

11 DR. PEKAR: Yes. We totally fall

12 on my sword on that. I totally agree that

13 that is confusing, and it doesn't help. But

14 let me then just make this point, that our

15 goal -- and I think Karen was talking about

16 this. We are not trying to simulate in a

17 sense reality with these.

18 We realize how important the

19 nature -- the spatial pattern of reduction can

20 be from a policy standpoint in terms of

21 influencing the risk reduction. So what we

22 wanted to do is have two bounding scenarios

Page 92

1 that we would hope would capture the reality

2 of what might occur.

3 One is proportion reduction where,

4 in attaining the daily standard, you are

5 driving everything down. I think that is a

6 very regional kind of response, a hyper7 regional response. 

8 Then the alternate example would

9 be this peak shaving which will --

10 DR. HOPKE: Well, the hybrid

11 approach catches a lot of that already.

12 DR. PEKAR: It does.

13 DR. HOPKE: So it is still not

14 clear to me what -- All right. Then it is not

15 clear to me what the difference between the

16 hybrid, because the hybrid is looking at the

17 local sources which might pull down some of

18 those higher valued results.

19 Again, it is just not clear to me

20 what the distinction then is between the two. 

21 Again, squishing the whole distribution down

22 is again hard to see how you would do. You

Page 93

1 know, that is almost similar to -- Well. 

2 So again, I think you want to have

3 your scenarios be something that has at least

4 some grounding in a practical strategy that

5 one could apply in terms of getting at this. 

6 So I am just not sure how easy it is going to

7 be to get distributions down in that sort of

8 way.

9 So I still -- If you are going to

10 put it in, it has got to have a much clearer

11 idea as to what it is that it is potentially

12 telling us that is informative in terms of

13 both the risks and potential implementation

14 strategies that would make sense in providing

15 additional protection, because right now, now

16 I am very confused, because the hybrid gives

17 you at least an implementation strategy. You

18 do your partially on your regional thing,

19 partially on your local. Okay. You know,

20 that is fine. But now to move the whole

21 distribution involves both regional and local,

22 because you have got to move the base as well
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1 as the peaks, and I am not sure how you would

2 do that.

3 As I say, it is just not clear why

4 this informs us better in terms of defining

5 the risk structure to get at appropriate

6 standard levels.

7 DR. PEKAR: So a couple of points. 

8 I think the hybrid -- The hybrid was intended

9 to be, I think, and is in between the

10 proportional and what we are calling the peak

11 shaving. The hybrid is likely -- I say this

12 waving my hands hugely, because we are not

13 trying to project, but it is likely more

14 representative for those specific local areas,

15 because we looked at sources.

16 So I agree. The reality was the

17 hybrid was not conducted -- was conducted for

18 a more limited set of the study areas, and we

19 knew that the peak -- sorry, that the daily,

20 the 24-hour standard, was controlling for some

21 city areas where we were only looking at

22 proportional rollback strategy, and we wanted

Page 95

1 to make sure that we had considered a bounding

2 alternate way of rollback for some of those

3 study areas, but I fully realize that, if you

4 got proportional and you have peak shaving,

5 hybrids in the middle, that that peak -- the

6 degree to which that represents a less than

7 likely bounding scenario -- I think, if there

8 is input from the panel members to really

9 basically characterize uncertainty associated

10 with that, would say that is a very highly

11 rare instance and would like to put some

12 caveats on the use of those estimates, I think

13 that is very useful to us.

14 So I appreciate that, but

15 certainly, the hybrid was more sophisticated

16 and made an effort to be more site specific,

17 and I fully recognize that. They are very

18 different.

19 CHAIRMAN SAMET: So I think to

20 summarize then, I think this discussion -- and

21 we will get to you, Joe. Two problems come

22 up. One is you haven't described well enough

Page 96

1 what it is you have done, and I think we were

2 all mystified, and the second, I guess, is

3 what is the most real world relevant of the

4 set. Joe?

5 DR. HELBLE: Thank you, Jon. 

6 Since you have already fallen on your sword,

7 Zach, I won't twist it further. 

8 I share those comments. I read

9 through this several times, and I first had a

10 hard time understanding the distinction

11 between this and the hybrid approach, and the

12 hybrid approach physically made sense to me,

13 and I would have expected that that was a

14 bounding scenario where you are looking at

15 what you can do locally, allowing local

16 controls to propagate through the system and

17 then saying let's also look at the effect of

18 regional controls and what that does to

19 overall PM levels.

20 Peak shaving -- I found myself

21 somewhat mystified. Now having said that in

22 my comments, I said, if you want to play "what

Page 97

1 if" scenarios, sure, it is another one that

2 you can examine, but I didn't see what

3 physical insight it provided in terms of

4 ultimately devising or recommending control

5 strategies.

6 So let me leave it at that and

7 simply say I agree with the other comments

8 that have been made.

9 The other comment with regard to

10 filling out the database and dealing with

11 missing values, I would simply ask a question. 

12 In addition to different ways of modeling

13 this, my question was: Did you test the

14 interpolation or imputation scheme that you

15 put forward?

16 You have a few areas where you

17 have robust data. One could randomly delete

18 certain data points, calculate or then impute

19 those values and look at that. So there is

20 your experiment. compare the calculated

21 values to what you actually had as measured

22 and say, is this strategy any good or are
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1 others better. So if you haven't done that,

2 I would suggest taking a look at that.

3 DR. PEKAR: I think a split set

4 analysis or some form like that, I think,

5 makes a lot of sense. I think, just to be

6 very honest, you know, there are only a number

7 of diagnostics that we can do, and I think

8 that that is something that we can put in

9 line.

10 I think it would be valuable, and

11 I agree, to see what effect that made. I

12 think my intuition is, because -- intuition is

13 a dangerous thing, I realize. But my

14 hypothesis that would be better supported by

15 actually doing the assessment would be, given

16 that we are talking about annual estimates, I

17 have a little less concern, annual estimates

18 being so critical.

19 I will say this. When we had the

20 alternate way of working with the monitoring

21 data where -- and this has more to do with the

22 weighting of the monitors and the way you

Page 99

1 generate the composite monitor average. But

2 when you weighted it based on the end, the

3 sample size, rather than giving each monitor

4 equal weight, that did make a difference at

5 times, because we tend to sample -- oversample

6 areas that have higher -- so we went with this

7 alternate way, but that is different than the

8 imputing issue.

9 The only point I will say about

10 the imputing is we have a localized strategy

11 for imputing clearly. It is very localized. 

12 It is a local window approach.

13 My read on the suggestions that

14 were made was there may be a global trend you

15 may want to consider. Maybe that is a fair

16 way of looking at it and, certainly, that is

17 conceptually an alternate and a very viable

18 way of looking at it.

19 I think that sensitivity analysis

20 would have been good to look at. I'm not sure

21 we are going to have time to do that. But it

22 is certainly, I think, one of the research

Page 100

1 directions might be, as we step toward the

2 next analysis -- I guess it is sort of a

3 cheesy thing to say is -- to chalk that up as

4 something when we have a little more time to

5 really look at that to make a better, more

6 informed decision on which way to impute. 

7 Just trying to be honest about the time.

8 CHAIRMAN SAMET: So this is a

9 comment to sort out these three alternatives. 

10 Even if you took data from several

11 representative cities, maybe one, as you say,

12 that is sort of peaky and one that is not, and

13 showed the monitor values, and then the

14 distributions that result from the three

15 different strategies for the city -- I am

16 going from sort of the original to the

17 rollback, the hybrid, the peak shaving,

18 whatever we are going to call it now -- maybe

19 that would help, just to try and understand

20 what you are actually doing and what it looks

21 like under different scenarios. 

22 I don't know. Phil, Ted, do you

Page 101

1 think something like that would be helpful?

2 DR. RUSSELL: Yes, I thought an

3 example would really help.

4 CHAIRMAN SAMET: Yes, and maybe a

5 couple sort of the bounding cases of

6 distributions might work. Frank?

7 DR. SPEIZER: I actually thought

8 that they did that with Appendix E-49 or F-49,

9 F-50, and I was immensely impressed that there

10 was at least a relatively consistent change in

11 one direction by using what was called peak

12 shaving.

13 Now I don't think I understood

14 what peak shaving meant, and now that you tell

15 me it is the shift of distribution, does that

16 also mean that the peaks come down in that

17 distribution or just the whole distribution

18 shifted one way or the other? I don't know.

19 DR. PEKAR: So, yes. I mean, the

20 peak shaving is essentially -- If you have the

21 distribution, the 98 percentile value is --

22 the design value, the daily design value is 30
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1 percent above the daily standard. You are

2 going to reduce every daily value at that

3 monitor by 30 percent, which will get you in 

4 attainment of that daily standard. You will

5 be meeting the simulated daily standard level,

6 but the entire mean for that monitor will also

7 drop by 30 percent.

8 The point that is really important

9 is, compared with proportional, you do nothing

10 to the other monitors. That is the reason

11 that the annual average can be left higher

12 with peak shaving.

13 If we have a daily exceedance and

14 we push all the monitors down by the amount to

15 get that daily monitor into exceedance, you

16 are going to have the entire annual average

17 across all the monitors, if you are using a

18 mortality analysis, driven down by that

19 percentage. 

20 With the peak shaving that we are

21 doing, you are targeting the one or two

22 monitors, whatever number that exceeded the

Page 103

1 daily, but leaving the other monitors

2 untouched. 

3 So the annual average will tend to

4 be higher, and that is why you saw -- from

5 your comments, I think that is why you saw

6 some of those levels higher under peak

7 shaving, because you were leaving the other

8 monitors alone, and the annual average is

9 higher.

10 DR. SPEIZER: But isn't that

11 exactly what the implementers will need to

12 have in the way of information that, in fact,

13 if they can target sources that are causing

14 those peaks, you can bring things down into

15 compliance? I don't know the answer to that.

16 DR. HELBLE: But if I could just

17 ask a follow-up question, isn't that what the

18 hybrid scenario is designed to get at? 

19 DR. PEKAR: So the hybrid scenario

20 gets kind of at that. The hybrid scenario has

21 an additional reduction in the monitor that

22 exceeds the daily, such that it now matches

Page 104

1 the other -- the nearest monitors around it,

2 and there is a distance to K-effect on the

3 other monitors. So it is a more targeted but

4 -- it is a hybrid. It has got elements of

5 both.

6 The peak shaving is clearly going

7 to be a more bounding example where you are

8 just able to say that monitor and whatever was

9 influencing it needs to be tightened, and we

10 are not expecting any effect on the

11 surrounding monitors. The hybrid has a

12 targeted effect on the exceeding monitor that

13 exceeds from the daily, and a distance to K14 effect on the monitors around it.

15 DR. HELBLE: So if I could repeat

16 what you said, just to make sure I understand

17 this for clarity, put it a different way; in

18 the peak shaving scenario, what you are really

19 doing is saying, here is an air quality basin

20 that is treated by this monitoring. Whatever

21 we do in that basin does not have any effect

22 on surrounding regions; whereas in the hybrid

Page 105

1 scenario, you acknowledge that the PM comes

2 from a mixture of sources, and so you allow

3 controls implemented here to have some effect

4 on depressing the baseline, decaying with

5 distance as you move away from the localized

6 controls.

7 DR. PEKAR: Right. That is

8 exactly right. So, clearly, that peak shaving

9 is more bounding. I mean, it becomes more

10 bounding as we talk about it in terms of

11 representing that very specialized case. But

12 again, I would just reiterate that, when you

13 conduct the risk assessments -- The way I sort

14 of think about this is, it is sort of a

15 sensitivity analysis on this critical issue of

16 variability in the way reductions may occur.

17 If we saw that the peak shaving

18 didn't really affect degree of risk reduction

19 relative to proportional, we would know that

20 this issue is not very important. 

21 What we see is that in certain

22 areas we have very peaky PM2.5 distributions,
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1 and where the daily standard is controlling,

2 the way you conduct your rollback or the way

3 monitor levels are reduced can have a pretty

4 substantial effect on risk, and that is

5 information we would want to convey to the

6 Administrator, but I think the point that

7 would be important for us to have is, if folks

8 feel that that peak shaving is highly -- less

9 realistic than the hybrid, for a variety of

10 reasons, I think that is very useful.

11 DR. HOPKE: It is hard to imagine

12 how you could have one monitor not affecting

13 other monitors in the region. So that, again,

14 the disconnect seems to be really problematic.

15 DR. PEKAR: Maybe sort of pushing

16 that a little further, it might have been more

17 optimal if the hybrid were used in a wider

18 number of locations.

19 DR. HOPKE: Exactly.

20 DR. PEKAR: So that -- and I hear

21 you on that. I hear you on that. Yes. 

22 CHAIRMAN SAMET: Excuse me. 

Page 107

1 Whoever is on the line, can you please mute

2 your lines. Sounds like somebody has sheep in

3 the background. Lowell?

4 DR. ASHBAUGH: Yes. Well, I think

5 we have actually gotten the point I wanted to

6 make. I actually thought you described the

7 peak shaving quite well. I did understand it. 

8 It was bringing that whole monitor down, but

9 what I thought was so unrealistic is that

10 there were no other monitors affected, just 

11 that one, and I just thought that was far too

12 local.

13 I understand the reason why you

14 were doing that is it is a bounding mechanism,

15 but I think that it would be important then to

16 say that this is an unrealistic bounding

17 assumption or bounding scenario where the

18 hybrid is much more realistic, because it does

19 allow for some spillover of any controls that

20 affect a high monitor to also affect other

21 monitors nearby. I think that is much more

22 realistic.

Page 108

1 I actually thought you described

2 it pretty well. I understood that you were

3 bringing the entire monitor down that was

4 high. It just didn't seem to be an realistic

5 scenario.

6 CHAIRMAN SAMET: Sverre?

7 DR. VEDAL: I agree with that. I

8 think that you might take it a little further

9 and think the proportional rollback is as

10 unrealistic as a boundary case as peak

11 shaving. In that sense, you know, those two

12 bookends may have some -- there may be some

13 point to showing them both, but I agree that

14 the hybrid is the one they should put the most

15 weight behind.

16 CHAIRMAN SAMET: Other comments? 

17 This was charge questions 1a and b. Ted,

18 anything you want to summarize or go back to

19 at this point? 

20 DR. RUSSELL: I think, actually,

21 for the most part we are fairly consistent on

22 what our response is going to be, basically

Page 109

1 saying make this section more clear. It might

2 be useful to provide an example, and in terms

3 of how they do the averaging, they should test

4 it, just to make sure that it works and

5 doesn't introduce any biases.

6 CHAIRMAN SAMET: I think what we

7 might do -- we are due for break at 10:30. We

8 can either go on to charge question 2, which

9 probably would take a fairly -- you don't

10 think it would take long? Okay, then let us

11 go ahead to charge question 2.

12 DR. LIPPMANN: Charge question 2

13 is pretty simple. I will read it. It is so

14 short: We have expanded and clarified the

15 discussion of our rationale for identifying

16 modeling choices comprising the four risk

17 models, focusing in particular on selection of

18 CR functions. To what extent does the Panel

19 consider this discussion to be clear and the

20 model selections appropriate?

21 We have comments from several

22 other members of the Panel, Wayne, Helen, Bob
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1 Phalen. Kent Pinkerton hasn't provided any so

2 far, and Ed Avol provided some, even though he

3 wasn't charged with doing so.

4 We all felt that there wasn't much

5 to pick on in terms of how they proceeded, and

6 the Panel, in my view, should commend the

7 authors for expanding and clarifying their

8 rationale for identifying modeling choices

9 comprising the core risk model in a logical

10 and satisfactory manner.

11 Their model selections were, for

12 the most part, appropriate, and anybody who

13 provided comments who wants to expand on that

14 I have spoken to, but they were largely

15 congratulatory. But I had some specific nits

16 to pick in the section where the thing was

17 discussed and, in particular, the morbidity

18 model.

19 This, I found disconcerting in

20 that I called attention to the fundamental

21 error at the last meeting, and that is the Ito

22 et al study which was the only morbidity thing

Page 111

1 analyzed was a study in New York City, and

2 apparently some people don't understand that

3 New York City is not Manhattan.

4 There are five boroughs, and there

5 are five counties, and the county names don't

6 correspond exactly to the borough names. 

7 Staten Island is Richmond County, and Brooklyn

8 is Kings County. Queens County is Queens

9 Borough, is the borough also. Manhattan is

10 New York County, and that is historical,

11 because originally the City of New York was in

12 Manhattan. It wasn't until 1898 that Brooklyn

13 and Queens joined under the rubric of New York

14 City, but that is where most of the people

15 live.

16 So not only is it mislabeled, but

17 it apparently is miscalculated, because

18 according to the tables, the population of New

19 York is 1.6 million which, I think,

20 corresponds to Manhattan or New York County.

21 So there clearly needs to be some

22 technical correction in that, not that it is

Page 112

1 a big thing, because mortality is driving

2 everything, but if you are going to put a

3 morbidity calculation in there, at least get

4 it right.

5 The other thing, which again is

6 something I keep bringing up but it gets

7 ignored, is in terms of the ACS cohort. Some

8 important information is not brought up in the

9 discussion, and I think it needs to be.

10 That is the ACS cohort is a

11 nonrepresentative population. It was much

12 more middle class and to upper middle class

13 than the national population, and within that

14 study it was clearly demonstrated that the

15 risk was concentrated in the lower SES

16 component of the population.

17 So to use the overall population

18 as a representation of risk without a

19 correction, which could be made mathematically

20 very simply, for what it would be for estimate

21 anyway of what a representative U.S.

22 population risk coefficient would have been,

Page 113

1 I think, is a serious deficiency.

2 Also, there is a simple

3 misstatement in there about the size of the

4 population. The size of the ACS cohort was

5 indeed about 1.2 million, but the whole cohort

6 couldn't be used, because it was restricted to

7 those communities which had monitoring, and so

8 the number of communities has changed from the

9 original 53, I think, or 65 or something like

10 that in the latest work-up, but that is just

11 a simple -- a misstatement of the population

12 that was being studied.

13 So those were the only nits I

14 would like to pick on the treatment. I think

15 -- I hope that my concerns are not neglected

16 a second time, but I hope you will get it

17 right. Then in the final version they will be

18 corrected.

19 CHAIRMAN SAMET: Thanks, Mort, and

20 there will be quiz to EPA on the burroughs and

21 counties in New York later in the day.

22 I do think it is a question of the
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1 bias direction, which we should probably come

2 back to for more general discussion, the

3 question of whether beyond a qualitative

4 statement about directionality, whether some

5 quantitative adjustment could be made, a

6 complicated question. Wayne?

7 DR. CASCIO: Yes. I agree with

8 Mort's comments, and I appreciate the history

9 lesson. I don't know much about New York

10 City.

11 In general, my comments are very

12 positive, and I thought it was a very well

13 written section and easily understood. I

14 would just like to say that I thought you all

15 did a really good job in going back to the ISA

16 and drawing that information into the

17 discussion of the CR relationships. 

18 I was particularly pleased to see

19 that there was an honest assessment of what

20 you know and what you don't -- you know, what

21 the uncertainties are and why you chose not to

22 incorporate certain endpoints or certain

Page 115

1 studies. That is really all I have to say.

2 CHAIRMAN SAMET: Helen?

3 DR. SUH: I have not much more to

4 add to that. One thing I thought was really

5 curious -- and I didn't include it in my

6 comments, but I just thought maybe I would

7 ask. There was a statement in the text that

8 said that the endpoint that was considered

9 ended up being the causal and the likely

10 causal, and that was just a by-product of all

11 the other criteria that happened.

12 So then I was wondering, given

13 that, is that really -- was really just a by14 product. I don't know if it was -- I wasn't

15 sure if that was really completely the way. 

16 It wasn't really just a by-product. So I was

17 wondering.

18 DR. PEKAR: You know, by-product -

19 - I think what we meant to sort of describe is

20 that we had a systematic process for

21 identifying those health endpoints, which

22 included the strength of the association

Page 116

1 information, which is really, really

2 important. 

3 You know, we may include a lot of

4 things in the policy assessment evidence

5 analysis that we can't include in the risk

6 assessment, because we don't have baseline

7 incidence rates. We don't have well defined

8 concentration response functions or other

9 aspects of that.

10 So once we walk down looking at

11 strength of association, whether we have the

12 information, not just from the epi study --

13 the baseline incidence rates are often a real

14 issue for specialized populations -- then that

15 gets you a set of endpoints that we model. 

16 But the point is that we did go into only

17 looking at causal.

18 If there had been -- there are,

19 obviously, some endpoints we have talked about

20 that we are interested in, frankly, in

21 quantifying from the risk assessment

22 standpoint, but we don't have the information

Page 117

1 to quantitatively assess those. Birth

2 outcomes would be one where we don't. 

3 Exposure time window, how to deal with that,

4 how to get the right metric is very

5 challenging from a quantitative standpoint,

6 for instance.

7 So we would have -- the point is

8 we are not limiting it to causal.

9 CHAIRMAN SAMET: Okay, anything

10 else, Helen?

11 DR. SUH: No, that is it.

12 CHAIRMAN SAMET: Bob?

13 DR. PHALEN: Well, I apologize in

14 advance, Jon and Karen, but I think I have to

15 make these comments.

16 The document is extremely well

17 written and very well defended, but I feel

18 that the people in EPA have one hand tied

19 behind their back when they are trying to do

20 a risk assessment, and the true talent that

21 exists within the EPA, I don't think, can be

22 expressed.
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1 When I say one hand tied behind

2 their back, I am relating to limitations,

3 having to have a mass-based metric. It is

4 clear that the science is going after

5 components and that components are driving the

6 health effects.

7 The second is not being able, by

8 policy, to take into account secondary health

9 effects. Not all of the effects of the

10 decision on abatement are direct. There are

11 indirect health effects, and I am not talking

12 about the cost, although that is significant

13 as well, but I am talking about indirect

14 health effects, so of controls.

15 Also, the risk assessment is very

16 limited, again by policy, and the National

17 Academy has recommended in 2008 that, when you

18 perform a risk assessment, first you look at

19 the reason for the risk assessment and how it

20 will be used. 

21 If it is going to be used to make

22 a decision, which in this case it is, then one

Page 119

1 needs to look at all the risks associated with

2 the decision, in this case all the health

3 risks. How might health potentially be harmed

4 by a restrictive standard should also be

5 addressed. Maybe it won't be harmed; maybe it

6 will. But that needs to be addressed.

7 Then having to have national

8 standards is a real drawback, because as you

9 look at these cities that have been selected

10 as the cities that form the basis of the risk

11 assessment, you have places like Atlanta,

12 Houston and Dallas with very high PM, and 50-

13 60 percent of the death rate from all of these

14 causes, 50 percent of the national average

15 death rate from all these causes that are

16 looked at.

17 So having to be forced to have a

18 national standard, in my opinion, doesn't

19 allow EPA to do justice to public health. 

20 That is it for pontification.

21 CHAIRMAN SAMET: Okay. So you

22 raised a set of issues that are not directly

Page 120

1 related to charge question 2, and I think

2 perhaps Karen alluded to some of these

3 comments in her earlier remarks. 

4 I think the approach and scope of

5 both the process of setting the NAAQS and risk

6 assessment is constrained in some ways, and I

7 think some of those constraints are given in

8 the introductory chapters to the REA in terms

9 of the context, in the regulatory context and

10 some of the Congressional interpretation of

11 these issues.

12 I wonder perhaps, Karen, if you

13 want to provide any further response. It is

14 true that the risk assessment focuses

15 specifically on health outcomes attributable

16 to particulate matter, and the documents

17 leading up to this, of course, have reviewed

18 the information relevant to components and

19 whether that information, in one way or

20 another, whether it is separating out PM

21 further by ultrafine or by one or other

22 components or season, which in a sense is the

Page 121

1 same, actually, the scientific evidence is

2 ready for that.

3 I think the documents say, no, not

4 yet, but I think everyone hopes that

5 eventually we will have more a refined

6 understanding. But I wonder, Karen, if all

7 would like to respond.

8 DR. MARTIN: Yes. I think it is

9 real important to distinguish the issue of the

10 indicator for fine particles from some of the

11 other issues that were raised. We aren't

12 constrained to have an aggregated mass

13 indicator. That is what we have evidence to

14 support, and we specifically look in this

15 review, has enough evidence emerged to

16 consider additionally adding or substituting

17 component based standards.

18 We all can discuss that as we

19 discuss the policy assessment, but that is

20 clearly on the table as a science driven

21 approach to setting the standard. So I don't

22 see that is precluded by anything except lack
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1 of sufficient information.

2 The other issues -- what precludes

3 consideration of some of those considerations

4 is the law itself. It is how Congress wrote

5 the Clean Air Act and how they interpret and

6 how the review in courts have interpreted that

7 intent.

8 So issues about unemployment

9 caused by impacts on industries to control to

10 meet standards are not the kind of effect that

11 we are allowed to consider as part of the

12 basis for the standard. 

13 If PM in the air had both

14 detrimental and beneficial effects, we would

15 look at both of those things. If breathing PM

16 helps some people and hurt other people, we

17 would look at those both together, but these

18 other tangential effects associated with

19 meeting the standard are all part and parcel

20 of the preclusion of not being able to

21 consider the cost of meeting the standard. 

22 That is not what Congress intends us to base

Page 123

1 the standard on, and everything else that

2 flows from the cost of meeting the standard is

3 part of that range of things that the standard

4 is not to be based on.

5 CHAIRMAN SAMET: Bob?

6 DR. PHALEN: That is well said,

7 Karen, and I understand. My comments are

8 basically implying that I wish you had a

9 mandate that was a little more holistic and a

10 little more broad, but I certainly don't

11 disagree with your comments.

12 CHAIRMAN SAMET: Well, you can

13 remember that the Clean Air Act was last

14 amended in 1990, and perhaps sometime in our

15 lifetimes there will be further amendments

16 that may change the scope of the Act, but for

17 now we are dealing with the Clean Air Act as

18 amended in 1990. 

19 We had some lingering issues. I

20 want to ask others if they want to respond. 

21 But I think we do need to come back to the

22 point that Mort raised, the questions of nonPage 124

1 representativeness, higher socioeconomic

2 status, implications for treatment of the

3 estimate from the ACS and whether, I guess,

4 you think it might be an underestimate because

5 of the higher socioeconomic status.

6 DR. LIPPMANN: That was what I

7 intended to say, that clearly, it is an

8 underestimate, if it could be corrected to

9 represent the population as a whole. It is a

10 large population. 

11 Therefore, you could make some

12 informed speculation about the proportion in

13 different socioeconomic levels and their

14 different risk factors, and apply the overall

15 population information to make such an

16 estimate.

17 It would, of course, bring the

18 risk estimate for the ACS cohort closer -- not

19 all the way, but closer -- to the six cities

20 estimate, and I think that would be a very

21 valid discussion point. 

22 The six cities was not a study of

Page 125

1 convenience, as the ACS was. That was a study

2 in which data were available on personal risk

3 factors for a cancer population study in

4 relation to diet, and for very modest

5 expenditure, while Arden Pope was on

6 sabbatical at Harvard, was under 15k probably,

7 a very important initial report on that

8 population and its response to mortality and

9 long term exposure was launched.

10 All of the refinements have been

11 mostly in terms of statistical methodology and

12 updating of the cohort, and those are all

13 admirable scientific studies, but it was very

14 early recognized that it wasn't a

15 representative population; whereas, I think

16 Frank can correct me if he wants to, but the

17 intent of Ferris and Speizer in setting up six

18 cities was to pick reasonably representative

19 people, at least in the eastern half of the

20 United States.

21 So it was much closer. it was not

22 a NHANES study, which is strictly a population
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1 representation base, but it was a much more

2 clearly reasonably representative

3 socioeconomic cross-section of those six

4 communities.

5 This is all important context, if

6 you are using these particular cohorts.

7 DR. PEKAR: Can I -- Just to give

8 a little feedback? I think, certainly,

9 qualitatively discussing that issue, the SES

10 difference in how that could result an effect

11 estimate that we see that is lower.

12 I think the one point I would want

13 to make on trying to some kind of quantitative

14 adjustment: One of the challenges is that the

15 latest 2009 release of the additional analyses

16 really pushed the statistical model assessment

17 much, much further, but it also didn't include

18 some of the earlier differentiation on SES. 

19 That makes some of those

20 adjustments a little more challenging, because

21 in that report -- I'm sort of going off in

22 memory; I haven't looked at it in a little

Page 127

1 while, but it didn't have the kind of SES

2 differentiation of those more refined, updated

3 model forms in the additional survey period.

4 So I think my concern would be, if

5 we were going to do an adjustment, it might

6 have to be based on earlier CR functions or

7 analyses done on the earlier version of the

8 dataset and couldn't as easily reflect the

9 latest version. It is a little bit of a

10 limitation.

11 DR. LIPPMANN: Well, I wish

12 attention had been paid earlier, so that it

13 wouldn't be now last minute estimation with a

14 significant effort, but at least, even now, I

15 think much more discussion is warranted.

16 CHAIRMAN SAMET: Helen?

17 DR. SUH: I think this gets a

18 little bit into the charge question 3 about

19 this whole notion about variability, and does

20 touch on SES. You are right, Zach. I thought

21 that was nice, but I think there is an easier

22 way perhaps than trying to adjust the ACS

Page 128

1 estimate.

2 It is to include the six cities

3 estimate or something like that as sort of a

4 sensitivity analysis to look at the effects of

5 using a different risk estimate. That was

6 something that we had discussed prior in the

7 previous meeting as a possibility, that not

8 really -- I mean, it was done somewhat here.

9 Right? 

10 DR. PEKAR: Yes, because one of

11 the sensitivity analyses was done with the six

12 city estimate.

13 DR. SUH: So I think that it does

14 get somewhat at your point, Mort, not as you

15 had suggested perhaps, but in a different way

16 by using these other estimates from the other

17 studies to look at their effect on the risk.

18 So it is sort of perhaps to

19 address some of your issues about SES, it is

20 one way of kind of looking around at that.

21 CHAIRMAN SAMET: I would say that

22 it is a pretty complicated matter, because you

Page 129

1 have the original selection into the ACS

2 cohort and its difference from the population

3 at that time. You have differences in the ACS

4 cohort versus the U.S. population over time.

5 In addition, there is the aging of

6 the ACS cohort and the extent to which the

7 effects will be modified by age. Again, at

8 any point you sort of have these two time

9 period analyses or multiple time period

10 analyses. You have sort of an overall crude

11 estimate that incorporates any inherent effect

12 modification by the aging of the cohort

13 itself.

14 I think it is worthy of more

15 discussion. Whether you want to try and do

16 some sort of quantitative correction or

17 whether you really could do it with enough

18 certainty to even justify it, I think, is a

19 different matter, but I think you are hearing

20 it just needs more discussion.

21 I guess, when we come to charge

22 question 3, maybe we will be back to this
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1 again.

2 Other comments on charge question

3 2? Sverre?

4 DR. VEDAL: Yes. I had a comment

5 that came up in my review of Chapter 6, but it

6 is more relevant here in terms of the choice

7 of the concentration response function, and it

8 has to do with the emphasis on ischemic heart

9 disease.

10 I was reading that later, and I

11 was wondering why all this emphasis on

12 ischemic heart disease rather than

13 cardiovascular disease, more generally. It

14 became clear. Then I went back to the Krewski

15 report. It doesn't report cardiovascular

16 endpoints. It is restricted to

17 cardiopulmonary, which is mixed up with

18 pulmonary, for which there is no effect, and

19 it is obviously an underestimate, if one is

20 looking at cardiovascular, and then focuses

21 and ischemic heart disease, which there is

22 justification for, but not to the exclusion of

Page 131

1 cardiovascular disease.

2 I think that argument is based on

3 Pope's 2004 paper where looking at the ACS

4 cohort, there seemed to be an elevated

5 relative risk for ischemic heart disease

6 versus other types of heart disease. I don't

7 find that all that convincing. I think there

8 is a lot of evidence of noise in those types

9 of subclassifications.

10 So it draws a little bit of a --

11 It introduces a little bit of question in

12 terms of the Krewski effect estimates then

13 having to be restricted to ischemic heart

14 disease, and it follows through all of the

15 improvements in risk and everything else. It

16 is all based on ischemic heart disease.

17 So I wonder if there are any

18 comments about that. I didn't see that as a

19 potential limitation of including the Krewski

20 study as opposed to other potential sources of

21 the CR function.

22 CHAIRMAN SAMET: Zach?

Page 132

1 DR. PEKAR: The point I can make

2 is that I think looking at a subcategory of

3 IHD, I think you can certainly speak to the

4 additional uncertainty that might be

5 associated with that, if there is some of

6 that.

7 It is certainly, as you say -- I

8 mean, the reason we ended up modeling IHD is

9 we had causal association, a strong causal

10 association from ISA based on cardiovascular

11 effects, specifically IHD being a subcategory

12 of that, and because we had the concentration

13 response functions associated with that, for

14 that endpoint. But I think that uncertainties

15 in stratifying and looking at a smaller and

16 more specific endpoint is something we can

17 speak to, certainly qualitatively, in the

18 analysis.

19 DR. VEDAL: Yes. I mean, we have

20 heard a discussion as to why the ACS effect

21 estimates are underestimates based on the

22 socioeconomic distribution, which is valid,

Page 133

1 but the focus on ischemic heart disease also

2 gives you a somewhat skewed estimate perhaps

3 in the other direction.

4 DR. SPEIZER: I would agree with

5 those comments. I was concerned about the

6 presentation of Table 311 which is, I believe,

7 the mortality rates that were included in

8 Bell's analysis.

9 DR. PEKAR: What page?

10 DR. SPEIZER: It is page 353. My

11 concern is that the missing-ness in this table

12 probably reflects all you got from Bell. Is

13 that correct? If not, then the table should

14 be completely filled in.

15 DR. PEKAR: Yes. Let me explain

16 this table and I think part of this is 

17 greater explanation in parts of the document. 

18 The table -- there are multiple entries for

19 the same study area, because depending on the

20 concentration response function, we had to do

21 different -- let me just double-check that I

22 am getting this right.
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1 So we would have different

2 combinations of counties for different

3 endpoints and, therefore, you would have

4 different baseline total rates, I believe, for 

5 the different endpoints. So it is not that we

6 are missing data.

7 For instance, if you look at the

8 Georgia-1 row there, that is speaking to the

9 short term mortality, and it is giving you the

10 -- and that had a different -- that study had

11 a different assemblage of counties. 

12 The next GA-1 -- and it is a

13 different all ages category. Then for GA-1,

14 the next row, greater than 30, that is

15 providing the baseline incidence rates used in

16 the long term mortality analysis.

17 So I think it makes it look like

18 there is missing data, and at times what we

19 should have done is been more clear that we

20 are mapping the concentration response

21 functions for different endpoints.

22 DR. VEDAL: You may just need to

Page 135

1 change the title of the table.

2 DR. PEKAR: Yes. 

3 DR. VEDAL: Baseline mortality

4 rate, to leave out COPD, it doesn't make any

5 sense. So you really need to redefine what

6 you've got here. 

7 DR. PEKAR: And to be honest, I

8 think this could go more in the appendix, and

9 we could describe conceptually where we have

10 coverage. I think that would better.

11 CHAIRMAN SAMET: Anything else on

12 Charge Question 2? So then why don't we break

13 for roughly -- Let's break all the way to

14 eleven, I think, and then get back together.

15 (Whereupon, the above-entitled

16 matter went off the record at 10:37 a.m. and

17 resumed at 11:08 a.m.)

18 CHAIRMAN SAMET: We are back in

19 session, and we are moving on to Charge

20 Question 3, which actually -- Helen, it is

21 you.

22 DR. SUH: Let me say first, Marcia

Page 136

1 is photocopying the committee members'

2 comments on visibility and will bring a copy

3 to everyone. I thought they were in the

4 packets, but they are not.

5 CHAIRMAN SAMET: Just for

6 planning, we are moving along pretty well. 

7 One thing we may do, and I think, actually,

8 Phil and Joe both, are you both leaving

9 tonight. So we may -- I think, if things go

10 well, we are going to try and get visibility

11 in this afternoon, which I think would work

12 well. I have you both here. Okay, good.

13 DR. FREY: Well, this is Charge

14 Question 3, which is on addressing uncertainty

15 and variability, and the main question is: To

16 what extent does the Panel consider these

17 discussions to be clear and appropriate?

18 I was jokingly going to say

19 unacceptable; do it over. But, no, I think it

20 was excellent. It was very well done. So

21 congratulations on a great job. I think the

22 comments I have are probably just minor

Page 137

1 comments, but I will go ahead and share them

2 anyway.

3 Let's see. There is a footnote

4 that explains the basis for identifying key

5 sources of variability. It would be helpful

6 to have some similar discussion on identifying

7 key sources of uncertainty, at least on the

8 qualitative aspects of that.

9 A very minor comment: I think EPA

10 did respond to comments from CASAC about

11 adding material about variability due to co12 pollutant concentrations. 

13 There is some discussion in the

14 related text about housing and the age of

15 housing having to do with air conditioning,

16 and then that has to do with infiltration

17 rate. I think that is maybe not quite the

18 whole story, that newer homes are typically

19 tighter than older homes, and even if they

20 have the same kind of AC system, older homes

21 would have typically higher infiltration. It

22 is a minor point.
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1 Another issue would be climate

2 zones. For example, housing in Boston, maybe

3 there is less central AC than there is in

4 Atlanta, Georgia.

5 Okay, let's see. Another comment: 

6 There were comments on the first draft REA, at

7 least in the detailed comments, that exposure

8 modeling is something that we would like to

9 see, and I think we understand that there is

10 time and resource issues and that that is not

11 going to happen on this version of the PM

12 standard revisions.

13 I just wanted to say that we would

14 like to see that in the future, and I think we

15 have all talked about that at the last

16 meeting.

17 I think there were lots of good

18 things in this revision. I think it is worth

19 making positive comments, not just negative

20 comments. So I think the treatment of the

21 concentration response function and looking at

22 different forms of the function and looking at

Page 139

1 single versus multi-city studies -- I think

2 that is all really nice stuff. So I am really

3 happy to see that.

4 In response to CASAC comments, EPA

5 did explain what was meant by low, medium and

6 high, I think as far as what the range or

7 magnitude of uncertainty is. I think, when we

8 made the comment, we recognized that those

9 definitions would probably be a little vague

10 and fuzzy, and they are a little vague and

11 fuzzy, but I think that is probably to be

12 expected, and I am not sure that that can

13 really be improved on.

14 There is one statement, and I

15 think this is on page 363 or maybe the

16 previous page -- I didn't actually write the

17 page number. It just says that high sources

18 of uncertainty are likely to influence the

19 interpretation of risk, and then there is a

20 parenthetical note "(if those sources of

21 uncertainty are reduced or more fully

22 characterized)." I didn't really understand

Page 140

1 why that parenthetical note was there or what

2 it meant.

3 It seemed to me, if you had high

4 uncertainty, you have high uncertainty, and

5 then talking about reducing uncertainty might

6 be something downstream of that. Maybe that

7 is an action you take by collecting more data,

8 but it wasn't clear what that had to do with

9 the definition of high. So I found that a

10 little confusing.

11 I think it is appropriate -- the

12 definitions of low, medium and high seemed

13 okay. There was some discussion that those

14 are based on a staff consensus, and I sort of

15 hesitate to make this comment, because I don't

16 want to make too big an issue of this, but it

17 did raise in my mind that, you know, this sort

18 of begs the question of what was the process

19 by which that consensus was reached.

20 You know, if one considers -- and

21 I know this was not a formal expert

22 elicitation, but if one looks at kind of the

Page 141

1 literature and the schools of thought on

2 elicitation, there are some concerns about

3 group processes, and it wasn't clear if this

4 was a group process, was this a staff meeting? 

5 Was it everybody got to write down their

6 comments, and then somehow there was

7 discussion later? If it was a meeting, you

8 know, sometimes you can have strong

9 personalities, and they carry the day, even if

10 they don't have the most meritorious

11 viewpoint.

12 So I am not sure this is a big

13 issue, but maybe a little bit of explanation

14 of the process by which the consensus was

15 achieved could be helpful.

16 On the other hand, I didn't

17 personally see anything glaringly wrong with

18 any of the characterizations in the summary

19 tables of what are the uncertainties, and what

20 is the knowledge base, and the bias and the

21 magnitude and so on. 

22 So I think, if anyone in CASAC has
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1 a concern about any of the conclusions that

2 EPA reached, we could address those, and in

3 the absence of CASAC saying that there is

4 anything particularly wrong with it, I think

5 that implicitly would imply that we agree with

6 what was the outcome of those staff

7 discussions.

8 I thought it was great that the --

9 I really liked the discussion of the

10 dependencies among pair-wise combinations of

11 sources of uncertainty, especially for the

12 concentration response functions. I was very

13 happy to see that.

14 I think this cuts across both

15 Chapter 3 and Chapter 6. It seems obvious

16 that the core estimates of risk come out at

17 the low end when you consider all the

18 plausible alternative estimates of risk that

19 come out of the sensitivity analysis, and the

20 sensitivity analysis is kind of couched in

21 terms of that it is addressing uncertainty in

22 a quantitative but not a probabilistic way,

Page 143

1 which I think is appropriate.

2 On the other hand, I think it is

3 still appropriate to -- when all the analyses

4 are done, is to maybe have some step back from

5 what the quantitative results are, and then

6 tie back in the qualitative assessment of

7 uncertainty. I am not sure I saw that in

8 Chapter 6. Maybe that is where it would

9 belong.

10 That was a comment that had been

11 made in our previous meeting, was that some

12 assessment, not only of the -- you know, the

13 implications of what can be quantified in the

14 sensitivity analysis, but things that maybe

15 can't be quantified, such as exposure

16 misclassification or some of the what seemed

17 to be known issues with using ambient data as

18 a metric for exposure in epi studies instead

19 of personalized exposure numbers, and how that

20 might bias the estimates.

21 That may tend to support the view

22 that, not only do the quantitative plausible

Page 144

1 alternative numbers come out to be higher than

2 the core estimate, but there is reason to

3 believe, furthermore, that if some of these

4 other sources could be quantified, that we

5 would have yet even higher estimates.

6 I won't make a comment, but I

7 guess there is an obvious perhaps policy 

8 implication -- maybe this gets into the policy

9 assessment -- of using core estimates that

10 seem to be at the low end of any other

11 alternative estimate. But I guess that is not

12 really a topic for this document.

13 I just have a couple of other

14 really minor comments on Charge Question 3. 

15 There is some text on page 356 that refers to

16 the true values of parameters of the model,

17 and that is followed immediately by text that

18 mentions that a model is -- you know, whether

19 it is an accurate representation of the

20 underlying physical system.

21 I think, just the term "true

22 values of the parameters" troubled me a little

Page 145

1 bit, because parameters are conditional on the

2 model, and the model may or may not be a good

3 representation of the real system.

4 So t he parameters, in a sense,

5 are an artifact of the model, and to say that

6 there is true values of the parameters almost

7 implies there is a true model. This is sort

8 of just a wording issue. I was trying to

9 think what is a better term than true value. 

10 I don't know if optimal value is better.

11 One could think of optimizing the

12 parameter of a model, given conditional on the

13 model that is selected. Maybe that is the

14 concept.

15 I think that is really all I have. 

16 I have a few other very minor comments in the

17 written text. I didn't have a chance to

18 iterate with Helen. So I invite you to add

19 your comments.

20 CHAIRMAN SAMET: Okay, Helen.

21 DR. SUH: I second Chris'

22 comments. I thought you guys did a great job
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1 responding to the previous comments and

2 incorporating them and putting together

3 something that made a lot of sense.

4 I agree that I thought it was a

5 little -- I don't know what the right word is

6 -- curious or interesting. Usually, when we

7 talk about uncertainty and the sensitivity

8 analyses, when you actually do all your

9 analyses, you usually get estimates that will

10 be in the positive direction and the negative

11 direction, and it seemed that the core was

12 actually very, very conservative compared to

13 all of the other analyses that you conducted,

14 which is slightly not typically how things

15 happen when you do a sensitivity analysis.

16 You usually look at things in both

17 directions. So I thought it would be at least

18 interesting to discuss or think about what

19 that might mean for your core analyses. Maybe

20 is your core analyses too conservative is one

21 way to think about it.

22 The other things, I think you did

Page 147

1 a good job of -- I realize a lot of it is

2 qualitative and not quantitative, but it might

3 be good to at least mention seasons --

4 seasonality as a source of variability, I

5 suppose, because PM peaks at different points

6 in different areas. So it might be good to

7 mention that and what might happen. That's

8 it.

9 CHAIRMAN SAMET: Charge Question

10 3, other comments? 

11 DR. HOPKE: Again, I would like us

12 to once again really push the -- In the next

13 round, we should see a much more really moving

14 toward the stochastic uncertainty. We asked

15 for this the last go-round five years ago. We

16 haven't gotten into it now. It is time.

17 CHAIRMAN SAMET: So I think that,

18 too. You know, in part this is almost a sort

19 of, in part, a research recommendation, that

20 you have a platform and framework now for

21 someone to do it. I think probably, Phil,

22 this is always left to development in the

Page 148

1 context of these documents, it will not happen

2 with enough time. We are talking about a

3 major effort, I think.

4 Other comments on Charge Question

5 3 and 4, I think, Chris, is you again.

6 DR. FREY: Okay, thank you. I was

7 just adding Phil's comment into my summary

8 here.

9 Charge Question 4: If you don't

10 have it in front of you, this has to do -- Do

11 you have a comment? 

12 DR. LIPPMANN: Yes. On 3, a point

13 to page 377, Section 3.5.3. It refers to

14 single and multiple elements as well as single

15 and multiple factors in terms of the

16 sensitivity analysis.

17 There is no definition of what is

18 an element and what is a factor. I had to go

19 to a later chapter to realize that elements

20 refer to modeling elements. So for clarity,

21 I think it should be introduced, the thought

22 of what it is you are referring to.

Page 149

1 Elements, it seemed to me, was a

2 poor word, because by next round we will be

3 talking about chemical elements, I hope, and

4 right now it would be a good idea to use some

5 other term for distinguishing between factors

6 and whatever else it is you are talking about.

7 CHAIRMAN SAMET: Okay, Chris.

8 DR. FREY: Thank you. Just for

9 the benefit of those who don't have the charge

10 question in front of them, this deals with

11 sensitivity analysis, and the basic question

12 is: What are the Panel's views on how we have

13 used the sensitivity analysis results to

14 support consideration of uncertainty in the

15 core risk estimates?

16 The general comments are, I think,

17 again very positive, that I think this

18 material was very good and nicely covered a

19 very complex topic. Table 4.3 is a useful

20 summary. There is a classification scheme for

21 small, moderate, moderate large, and large

22 contributions to sensitivity, which I think is
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1 helpful.

2 I would comment that, throughout

3 both Chapter 4 and into Chapter 6, that the

4 sensitivity results are referred to sometimes

5 as an uncertainty set or in terms of

6 uncertainty. I think that is not necessarily

7 wrong, but I think it is a little -- It might

8 be a little confusing to some readers, because

9 I think the text is also careful to say that,

10 while these are plausible alternative

11 estimates, they are not a probability sample,

12 and so there is not a probabilistic

13 interpretation. 

14 Maybe it is just better to refer

15 to them either as alternative estimates or

16 sensitivity results rather than an uncertainty

17 set. Maybe that is a fine point. it is not

18 a huge big deal.

19 I think -- let's see. The

20 evaluation of alternative model structure that

21 was part of the sensitivity analysis, I want

22 to strongly endorse that, and that is a very

Page 151

1 positive revision.

2 It is clear that comparing

3 different model structures is an important

4 source of variation from one estimate to

5 another, and particularly the random effects,

6 log log model, compared to the fixed effects

7 log linear model seemed to be a big

8 difference. Just generally, there is more

9 thorough treatment of model choices in

10 alternative functions, which I think is very

11 helpful.

12 There was a comment, which I think

13 was addressed in part but maybe not fully. So

14 in the last meeting, one of our comments was

15 to look at the range of uncertainty associated

16 with confidence intervals for a given

17 concentration response function. I think

18 that is accounted for in these Tables 4.1 and

19 4.2 in Chapter 4, that you do see confidence

20 intervals on the effects estimate.

21 Another comment we had made was

22 just to compare those confidence ranges to the

Page 152

1 ranges of outcomes you get by looking at

2 different functional forms of the model, just

3 to get an idea of, you know, is random error

4 for a given model -- say, for the core model -

5 - a more or less important source of potential

6 uncertainty than comparing alternative model

7 forms? 

8 So in other words, just comparing

9 the magnitude of the confidence intervals from

10 the core CR models to the range of values

11 obtained from different alternative functional

12 forms, I personally think would be

13 informative.

14 The sensitivity analysis tends to

15 focus on looking at percent changes in risk,

16 and sensitivity analysis often focuses on

17 variation, like how much does variation in an

18 input affect variation in the answer. 

19 So I think, from that perspective,

20 looking at percent differences is a natural

21 thing to do, but I think in terms of the

22 framework of the NAAQS, risk reduction is not

Page 153

1 really the policy goal, and the NAAQS are

2 intended to be protective of public health. 

3 So, therefore, the more relevant risk metric

4 is probably the number of adverse outcomes.

5 So a specific comment related to

6 that was in -- just looking at some of my

7 notes here. I think it is in Table 4.4 where

8 there are results from the sensitivity

9 analysis, and the column for results says

10 percent difference, but it doesn't actually

11 say percent difference in what. I think it is

12 percent difference in number of adverse

13 outcomes. 

14 That could be defined, but I think

15 it would be helpful to just -- even though it

16 is elsewhere in the report, to put the core

17 estimates of the magnitudes in that table or

18 in a footnote, so that when we are looking at

19 percent differences for some of the effects,

20 we know whether this is a percent difference

21 of a big number or a small number.

22 I think that covers basically all
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1 of my significant and semi-significant

2 comments. So I will stop there. They are all

3 statistically significant comments, yes.

4 CHAIRMAN SAMET: Helen.

5 DR. SUH: I agree with Chris, and 

6 I also have -- and I think this goes into some

7 of the other issues perhaps with some of the

8 other charge questions, one of which is I

9 didn't truly understand this notion of the --

10 when you did the substantive analysis with the

11 peak shaving and the rollback, and then there

12 was a discussion from there about the

13 peakiness of the cities and the 24-hour versus

14 the annual average and their effect.

15 I found it very confusing, and I

16 wasn't sure of the exact main points that we

17 are trying to get across. I guess the thing

18 I took from it was that maybe there was a

19 regional effect going on. I wasn't really

20 sure of, really, the main points that you

21 wanted to drive home, and I wasn't sure of --

22 and I guess that there is just some

Page 155

1 clarification perhaps needed, because it

2 seemed to be useful on one level, but I just

3 wasn't sure what the main points of it were.

4 The other thing that goes along

5 with that is I couldn't figure out if there

6 was basically some of the premises of the

7 overarching summary conclusions was that there

8 are these strong regional or strong city9 specific effects, that maybe they argue

10 against or may complicate the nature of doing

11 national standards, but I guess that is

12 something to consider, so you could carry it

13 forward to the policy analysis when you think

14 about who you are protecting and when the

15 standard may be more or less protective of

16 other groups.

17 So I thought that would be

18 something that would be useful to elaborate or

19 clarify here, so that for the policy analysis

20 it would just follow a little bit better.

21 CHAIRMAN SAMET: Other comments,

22 Charge Question 4, sensitivity analyses? 

Page 156

1 Mort?

2 DR. LIPPMANN: Just a technical

3 one on pages 445 in this section, 445 and 447. 

4 The figure numbers are mislabeled. Change 46

5 to 47. Yes, 46 and 47 to 48, and on page 47,

6 46 and 47, 47 and 48. 

7 DR. FREY: And I guess related, I

8 have some other numbering issues. It probably

9 would just be good to proofread Chapter 4 for

10 that.

11 DR. PEKAR: We will proofread it

12 for the first time.

13 CHAIRMAN SAMET: Okay. Other

14 comments? We have sort of been dealing with

15 uncertainty variability in t he sensitivity

16 analyses. Other comments? There is an awful

17 lot of information presented and, clearly, you

18 can always present more, and I think we have

19 some suggestions. I think the bulk of what is

20 needed is there and laid out.

21 Other questions? Sverre? Okay,

22 well, Sverre has nothing. We are moving on to

Page 157

1 Charge Question 5, which is you. Go ahead.

2 DR. VEDAL: All right. So Charge

3 Question 5 basically relates to some new

4 information or new ways of presenting data

5 that we have been provided with, and having to

6 do with design values, what is called t he

7 pattern of PM monitoring data or results, and

8 how that relates to some sensitivity analyses,

9 particularly some things that Helen just

10 touched on that we will talk about, as well as

11 information that looks at the role of the 15

12 urban areas selected relative to urban areas

13 in the rest of the country.

14 There were two charge questions. 

15 One was: How do we like this new information,

16 how it was presented and the discussion that

17 pertained to that and the points that were

18 gleaned relative to basically two sets of

19 figures, Figures 4-17 through -19 and then a

20 couple of others, 4-20 and -21, that the

21 discussion basically focuses on.

22 Then the second charge question
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1 was: Was there anything that was missed that

2 the committee would like to recommend be added

3 in consideration of those five plots?

4 I have had the advantage of being

5 able to see the comments of the other people

6 assigned to these charge questions, and I

7 won't steal their thunder, but will perhaps

8 foreshadow a couple of things.

9 I think the subgroup assigned to

10 this charge question were generally extremely

11 positive with these new displays. I think we

12 regretted not having them five years ago when

13 we had the -- when we were deliberating at

14 that point, and they are extremely useful as

15 a way of focusing our interest on the

16 distribution of cities, certainly, by the two

17 different averaging metrics and design values.

18 With respect to design values,

19 when I first read this, I am not so used to

20 the EPA jargon, and I glossed over the part

21 where this was defined earlier. So I was like

22 trying to figure out what a design value was.

Page 159

1 So I went to Google, and it was

2 the first hit, design value, defined it for me

3 there. It was my mistake, because it is

4 defined in Chapter 3, and pretty good, but it

5 might be worth just, rather than jumping right

6 into assuming that is to maybe refer one to

7 another place or an appendix or a definition.

8 The plots are also intended to

9 give us some information and insights into

10 what are called the patterns of PM monitoring

11 data. Zach went over some of that earlier,

12 and I think there are some insights, some good

13 insights, to be gained from that exercise

14 relative to various types of control

15 strategies.

16 I think we were happy to see sort

17 of looking at the effects of an annual

18 standard versus a 24-hour standard and the

19 relative impacts of those. I think that was

20 very insightful.

21 Then, as I alluded to before, this

22 issue of how well the -- and in what way the

Page 160

1 15 urban centers reflect what is going on in

2 the rest of the country.

3 We had a lot of discussion earlier

4 on the issue of rollbacks and how they are

5 done and how confusing they are. I don't

6 think there needs to be anymore said about

7 that. 

8 There are a lot of points made

9 with respect to rollbacks and how those are a

10 function of the PM monitoring data, and it is

11 tough for me as I get older to try to accept

12 and understand new things, but it is tough to

13 digest it all in a little nutshell in terms of

14 what the points are there. 

15 They are all good points, and I

16 like the way of sort of bookending it by

17 cities that have clearly different

18 characteristics, and that is helpful, but it

19 is still a little bit of a tough go.

20 One specific thing that I just do

21 not understand, and there is probably a real

22 simple explanation for it, is this issue of,

Page 161

1 if both the 24-hour and the annual design

2 value occur at the same monitor, the peak

3 shaving rollback of 24-hour values has a

4 bigger impact on the annual average design

5 value.

6 I don't understand why it makes a

7 difference that they both occur at the same

8 monitor site. It would seem that would be

9 just a trivial little -- anyway, maybe that is

10 a minor point that someone can explain, but it

11 may not need a general discussion.

12 The issue of peakiness has been

13 brought up before, and I think I understand

14 what you are referring to, the distinction

15 between the design values of the 24-hour

16 average versus the annual average and how

17 different those are.

18 In reading this, I got a couple of

19 mixed messages. I think most of that refers

20 to -- is in the temporal dimension, and so

21 when you have a site or a city where you have

22 a lot of temporal variability in the day to
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1 day, 24-hour values, that is going to be

2 reflected in peakiness.

3 There is a point, however, where

4 you are referring to peakiness within a city,

5 and specifically L.A. That is a spatial

6 dimension, a spatial dimension to peakiness. 

7 So you get confused as to what you are

8 actually meaning by peakiness.

9 One other person brought up this

10 issue of, I think, what is basically trying to

11 draw too much information from this figure,

12 and it had to do with this issue of Atlanta,

13 Birmingham and Houston, as to where you place

14 them on the plot.

15 There are some mistakes as to

16 where you placed them, and they vary from

17 across the three plots, but for example, if

18 you look right there, Atlanta is right on the

19 border between C and D, and Birmingham is

20 right on the border between B and C, but you

21 know, the discussion makes it appear that they

22 are in one or the other, and it goes on from

Page 163

1 there. So I think you are taking liberties

2 with what the actual plot is showing.

3 DR. PEKAR: Well, these

4 discussions -- and just to be clear, and I

5 think we should definitely clarify this. The

6 discussions in terms of controlling standard

7 levels and other aspects of that are going to

8 be based on the actual numerical value, and

9 the plot can be a little fuzzy, just because

10 of -- So you may be --

11 DR. VEDAL: Yes, I understand

12 that, but basically it means that it is just

13 a smidgen over the border, and one can

14 actually run for a touchdown with that kind of

15 distinction. I'm not sure.

16 DR. PEKAR: Well, that may be. 

17 That is a good point.

18 DR. VEDAL: I think the other

19 Panel members -- and I will let them talk

20 about some recommendations that they made with

21 respect to the plots that, I think, are -- we

22 may not all agree on, but are interesting to

Page 164

1 consider.

2 Before I get to some

3 recommendations, just what is Pitt Liberty? 

4 Why is that 16th point? Maybe it was

5 presented earlier in that thing, and I missed

6 it somewhere, but what is it?

7 DR. PEKAR: So in Pittsburgh we

8 have two different -- we treated Pittsburgh as

9 two different locations. In the risk

10 assessment they become one, but in terms of

11 conducting rollback we had two -- we divided

12 that city and its monitors into two different,

13 essentially, attainment zones that are very,

14 very different, and we conducted the

15 adjustment, the rollback, separately for those

16 two zones and then had one composite monitor

17 that was generated from both.

18 I think an artifact that we should

19 take care of is either deciding can we provide

20 the composite equivalent of this, if we can,

21 which may not be doable, or at least be clear

22 about why we have 16 instead of 15 red stars

Page 165

1 and what those -- So, yes.

2 DR. VEDAL: Right. All right. In

3 terms of recommendations for insight, my first

4 impression when I looked at that was it would

5 appear that, if you lowered -- if you just did

6 the 24-hour, brought everyone into compliance

7 with the 24-hour standard, you would pretty

8 much do what you wanted to do. Right? And if

9 instead you did the annual standard and

10 brought everyone in compliance with the annual

11 standard, you would still have some residual

12 number of cities that were still out of

13 compliance with the other standard.

14 Now as you go further along in

15 making your arguments, obviously, the case is

16 that you are going to prefer the annual

17 standard and all that, but the impression that

18 you get from looking at this is exactly the

19 opposite.

20 So you are almost going to have to

21 address this kind of initial impression that

22 you get on looking at this to counter that
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1 sort of approach. I am still going to make

2 arguments in favor of the 24-hour, but

3 nevertheless, the impression here is that,

4 gee, all the oomph is in the 24-hour standard,

5 not in the annual standard.

6 At the end of the day when you get

7 to your integrative summary, you know, it is

8 all coming down in argument in favor of more

9 emphasis on the annual standard.

10 DR. PEKAR: Well, I think one

11 point that we didn't clarify in the diagram,

12 really -- I mean, we clarified it in words,

13 but I think the diagram really offers this up

14 -- is that you got a lot of locations that

15 certainly exceed the daily, but if we think -- 

16 this presentation of this as skipping the X

17 axis down here, but this is 15. Right? So we

18 are looking at annual averages below that.

19 A lot of these guys have annual

20 average levels, if we are talking about

21 estimating mortality risk, well, we are going

22 to be less confident about making those

Page 167

1 estimates in this and the nature of the

2 relationship, not that it is not -- that we

3 don't believe health affects aren't occurring

4 there, but I guess my point is, if we were to

5 try to predict risk estimates for a lot of

6 these, they may be exceeding the daily and, if

7 we force them down, you are still dealing with

8 annual average estimates that are lower. It 

9 is a good point.

10 DR. VEDAL: Good point. Anyway, I

11 just thought it might be helpful just to

12 counter that initial impression, if you are

13 really going to go to bat for the annual

14 standard.

15 DR. PEKAR: Right, and I think

16 something -- Another point that was made

17 earlier -- if I can just give a little more

18 broader feedback.

19 We provide a lot of discussion of

20 these diagnostics and sort of explaining what

21 we see, and I think we had some observations

22 that are pretty strong, but I think there are

Page 168

1 some other sort of intermediate observations

2 that could be more clearly made, and I think

3 that has been pulled out by folks, that we

4 don't really have the take-home message on

5 some of these. I think we could sharpen that

6 up a little bit.

7 DR. VEDAL: Yes. I think that is

8 pretty much it. 

9 I won't talk about some of the

10 points that others made, and allow them to

11 elaborate on them in terms of other

12 recommendations and ways that you could go

13 that we could perhaps have discussion on. 

14 I'll finish.

15 CHAIRMAN SAMET: Thanks. Ted?

16 DR. RUSSELL: Right. As Sverre

17 said, I was very positively taken with this. 

18 The one thing that I could add was

19 that -- I think it is in 52-4 -- you break the

20 country up into different regions, and you

21 don't have any region from, I think it is, the

22 Upper Midwest.

Page 169

1 You could make up a figure very

2 similar to this that actually shows how the

3 various cities that you currently all in green

4 dots are assigned to each region, and that way

5 you would get an idea of what is the

6 distribution within regions, and you could

7 even make -- sort of have your domain of

8 possible standards and see is there places in

9 the upper Midwest or anywhere that sort of

10 falls in or outside. I just thought that

11 might be instructive.

12 CHAIRMAN SAMET: So anything else

13 that -- That is your A and B comments?

14 DR. RUSSELL: That was A and B

15 together.

16 CHAIRMAN SAMET: All right. 

17 Frank?

18 DR. SPEIZER: I don't have any

19 comments on this.

20 CHAIRMAN SAMET: Okay. Rogene?

21 DR. HENDERSON: Well, my comments

22 are very similar to Sverre's. I was very
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1 pleased with these figures. I am kind of a

2 visual person, and this helped me a lot in

3 putting everything in perspective.

4 When it came to discussing the

5 rollback method, we had a very good discussion

6 this morning, and that helped me tremendously

7 to see what they were talking about. 

8 My confusion here was why would

9 you think you had to roll back the annual and

10 the daily the same amount, because I think the

11 relationship between the exposures -- the peak

12 exposures and the average annual exposures is

13 very complicated and very dependent on where

14 you are and what the source of the high peaks

15 are, et cetera. 

16 So I didn't understand why you

17 would want to roll them back to the same

18 degree. It just didn't seem to make sense,

19 but we have had that discussion, and I talked

20 to Zach, and he helped me -- explained to me

21 over the break, but one thing, Zach, that you

22 said that bothered me a little was maybe we

Page 171

1 can't do it this time, but next time we will

2 be sure and use the hybrid method, or

3 emphasize it.

4 If we can possibly do that this

5 time, I think it is something that should be

6 done, because it puts us -- EPA wants to be

7 clear and transparent, and it is a defensible

8 method. So to me, it would be worth it to

9 reconsider and emphasize the hybrid rollback

10 method.

11 Now, as far as how I would improve

12 this, when I saw this and the light dawned and

13 I said, oh, I see what they are talking about,

14 I would like to have a third dimension in

15 which the health effects, at least for the 15

16 cities where we have those health effects,

17 could be projected, maybe little peaks coming

18 out from the surface there. But that is a

19 kind of a pipe dream, in a way, but this shows

20 so clearly the exposure situation. it would

21 be nice to have -- Do the health effects march

22 along with it or do they match? So that was

Page 172

1 my only comment.

2 CHAIRMAN SAMET: So you want to

3 borrow technology from Avatar and have --

4 DR. HENDERSON: Yes, that's right.

5 CHAIRMAN SAMET: -- videographs?

6 MR. AVOL: That being all of my

7 other colleagues' comments, I think it was

8 very well done. I do have two questions for

9 you, and one other comment.

10 With regard to your previous note

11 about proofreading, at the risk of being

12 slightly obsessive, I gave you a whole list of

13 proofreading. So I won't go through those,

14 but I did have two questions. 

15 One is there is a comment made

16 about Philadelphia and Los Angeles sort of

17 being representative, and it wasn't completely

18 clear to me why that was so. Los Angeles has

19 been called a lot of things, but

20 representative of all western cities is not

21 one of them. So I wasn't quite sure what the

22 basis for that was.

Page 173

1 DR. PEKAR: I think -- There was

2 no assessment to determine representativeness

3 on that. I think we needed -- To keep

4 ourselves from being overburdened in

5 conducting the sensitivity analysis, we needed

6 to select an eastern and western city.

7 I think the better way to put it

8 is L.A. is certainly of great interest to us

9 and Philly represents maybe a reasonable

10 eastern, larger eastern city, but I think we

11 overreached with that term.

12 I was reading your comments, and I

13 think we need to pull back from that and just

14 be a little more clear that there wasn't any

15 kind of --If we had -- And for some of the

16 sensitive analyses, we did model it. We did

17 include every city when we could, but -- Yes.

18 MR. AVOL: I think it was great to

19 go to the 15 city approach, and I just

20 couldn't quite follow why those two were

21 representative. So either a comment about

22 that or backing off on that would be fine.
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1 The other question is just to

2 follow up on your previous explanation of Pitt

3 and Pitt Liberty for Sverre. I don't quite

4 still follow why there is two, because

5 arguably, for example, in Los Angeles you

6 could separate out the western portion of the

7 Basin and the eastern part, and you get very

8 different plots, and you could also say, well,

9 that would be a couple.

10 So I am not sure why you need to

11 identify Pittsburgh as a place that needs two

12 of them.

13 DR. PEKAR: So in Pittsburgh there

14 was -- I guess a way to put that is that, in

15 talking to our air quality folks, when they

16 were gathering the monitoring data for us

17 basically in the counties of each city, in

18 Pittsburgh there is one monitor that is

19 extremely high, just very, very, very high.

20 If you group that and you do

21 rollbacks, particularly proportional rollback

22 based on getting that to a T, you have massive

Page 175

1 reductions in everything. When they looked

2 into that, they found that there was this

3 definition.

4 So I think the way I would say it

5 is we were able in Pittsburgh relatively

6 easily to come up with maybe a more

7 representative -- I don't want to say

8 realistic, but more site specific approach

9 toward what we think is going on there, and in

10 L.A., you are right. I think more

11 researchers, more time looking at that and

12 dividing it up is definitely doable.

13 If I can interpret what you are

14 saying, the criticism is really, hey, if you

15 did it there, there are other places --

16 MR. AVOL: I am not arguing

17 strongly for doing it there. I am just saying

18 that one can make the same argument that you

19 just made for Mira Loma compared to parts of

20 the Basin.

21 DR. PEKAR: Sure. Maybe one way

22 to think about that is it is a very poor

Page 176

1 sensitivity analysis, but we do know the

2 difference it made in Pittsburgh. That shows

3 that this can have substantial effects. So to

4 consider that maybe as a source of uncertainty

5 in some of our other urban analyses, I mean,

6 would we have driven things higher or lower if

7 we parsed out these attainment zones and did

8 rollbacks separately. What do we think would

9 happen?

10 I don't think, just to be -- I try

11 to be honest about these things. I think at

12 the time, we probably won't be able to do

13 something more refined in L.A. for this

14 assessment, but I think, to acknowledge that.

15 MR. AVOL: I would sort of be

16 inclined to put Pitt Liberty and Pittsburgh

17 together.

18 DR. PEKAR: All right. Well, just

19 to be clear, we did reaggregate them, and we

20 conducted the analysis. It was just the

21 rollback that was done differently.

22 CHAIRMAN SAMET: Frank?

Page 177

1 DR. SPEIZER: Yes. Thank you for

2 coming back to me. I did have some comments

3 that I probably ought to raise.

4 One was related to the Table 4.1

5 in which you mix both mortality and

6 hospitalizations, and it is not clear to me

7 that the denominators for those tables would

8 be the same. I just need to clarify whether

9 or not they are, because generally, the

10 hospitalizations are per 10,000, and the

11 mortality is per 100,000, and those are really

12 very different numbers, if that is the case. 

13 I don't know.

14 DR. PEKAR: I mean, the incidence

15 estimates -- The baseline mortality rates

16 might be expressed in different terms, but we

17 would have corrected for that. So these are

18 annualized estimates for short term mortality

19 versus long term mortality.

20 You know, certainly, working

21 backwards you would see that individual cities

22 might have been modeled in terms of the
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1 groupings of counties slightly differently,

2 depending on the underlying epi study, but

3 these are essentially representing the same

4 effort to characterize annual incidence for

5 the two different types of effects, categories

6 of effects, short term versus long term

7 mortality.

8 DR. SPEIZER: But what about the

9 hospitalizations? Aren't they in that table?

10 DR. PEKAR: Oh, sorry. Those

11 would have been total incidence estimates. It

12 is the underlying baseline mortality rates. 

13 Maybe I am misunderstanding your question. It

14 certainly would have differed, but the

15 estimate is an annual estimate of the actual

16 effect.

17 DR. SPEIZER: Well, yes. I

18 understand that. They are all relative, but

19 the question is what is -- The denominators

20 for mortality and hospitalizations might be

21 very different. I just don't know if they

22 are.

Page 179

1 DR. PEKAR: Oh, yes, yes. I would

2 need to -- Off the top of my head, I don't

3 remember exactly the age group to the two

4 effects. One is going to be based on

5 Schwartz. One is going to be based on Bell. 

6 I would need to look at the age groups.

7 We could be more specific for the

8 population that is reflected in these. 

9 DR. SPEIZER: You just need to

10 clarify. Maybe a footnote will do it.

11 DR. PEKAR: Okay.

12 DR. SPEIZER: The other -- back to

13 this issue of Los Angeles versus Philadelphia. 

14 I had trouble interpreting what Figures 4.7

15 and 4a are showing, and in my interpretation

16 of it, it looked to me like the change in L.A.

17 went from five to 10 percent to as high as 19

18 percent. In Philadelphia, it was, I guess, 10

19 to 15 percent up to 23 percent, and for total

20 mortality -- That was, I guess, for heart

21 disease. then for total mortality, the

22 changes were much lower.

Page 180

1 Now if 40 to 50 percent of the

2 total mortality is heart disease, I am not

3 sure I understand why the deltas are so

4 different.

5 DR. PEKAR: I'm sorry. I am a

6 little bit behind on the figures.

7 DR. SPEIZER: Well, you may just

8 want to look and see my general comment, just

9 review them to see whether it makes any sense,

10 but I was concerned about the differences in

11 the deltas that you have.

12 DR. PEKAR: Right. 

13 DR. SPEIZER: I think that is all,

14 Jon.

15 CHAIRMAN SAMET: Okay. So other

16 comments, Charge Question 5? Okay, then on to

17 Six, I guess, maybe before lunchtime.

18 DR. SPEIZER: Yes. Now there is

19 no Charge Question for Chapter 5, as far as I

20 can tell, and a number of issues were raised

21 by a number of the reviewers that this looked

22 rather tentative, and maybe whether it belongs

Page 181

1 here or belongs in an appendix, that is one

2 issue.

3 Perhaps more importantly, does it

4 make sense to have done a national estimate on

5 the basis of the 15 cities and where we know

6 or it is reported in the text that the 15

7 cities probably represent an upper exposure

8 level for the country. 

9 There are a couple of statements

10 that come up in Chapter 6 that reflect on how

11 you do this analysis for the national, and one

12 place it says three to nine percent excess

13 risk for half the country, zero to three

14 percent for the other half of the country.

15 I am just concerned that this has

16 got -- this number that gets generated for the

17 whole country may be too big. Also, I am

18 concerned that it is taking it down, I guess,

19 to the Krewski 2009 5.8 level, I think. That

20 has to be clarified for me.

21 So I thought we ought to have a

22 more general discussion about that before we
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1 get into the specifics of Chapter 6.

2 CHAIRMAN SAMET: So let's pause

3 there. So your posing that we discuss

4 essentially whether Chapter 5 should be

5 included as a main chapter?

6 DR. SPEIZER: Yes. Others have

7 raised that question as well.

8 CHAIRMAN SAMET: Zach, do you want

9 to make some explanation of the national?

10 DR. PEKAR: Yes, and I will give a

11 brief explanation. Basically, it was a grid

12 cell based analysis. So one thing, just to be

13 clear, and I think we talk about comparing the

14 15 urban study areas doing a representative

15 comparison based on the national morality

16 estimate. I think that can introduce a little

17 bit of confusion into this.

18 The national mortality analysis

19 was a separate analysis. We didn't scale up

20 the 15 urban study areas at all. We conducted

21 a grid cell based CMAQ hybrid monitor based

22 characterization of ambient air levels, but

Page 183

1 basically did a BenMAP. That is an incidence

2 estimation model.

3 So we modeled at the grid cell the

4 mortality for each grid cell in the U.S. So

5 that is the basis for the analysis. it is not

6 a scaled up. We didn't scale up the 15 urban

7 study areas.

8 Another thing is it is for recent

9 conditions. So just to be clear about that,

10 the reason the mortality estimate seems like

11 it is maybe a little higher than might e

12 expected is it is for recent conditions. It

13 is not assuming attainment of the current

14 NAAQS, but your correct that it does model

15 estimate. It does estimate risk all the way

16 down to the elemental 5.8.

17 So if you look at that, that is

18 assessing risk for, in some instances, greater

19 than a 10 microgram per meter cubed spread of

20 annual estimates. So you are going to get a

21 fairly larger estimate of incidence.

22 So I am not sure if that at least

Page 184

1 clarifies the approach that was used, and I am

2 not sure if Brian wants to add anything. 

3 CHAIRMAN SAMET: Frank, what is

4 your recommendation beyond wanting us to

5 discuss it?

6 DR. SPEIZER: Well, whether this -

7 - I think it is important we clarify that this

8 was not part of the 15 city part of the

9 analysis. 

10 My concern is that putting this in

11 here and suggesting that we are going to save

12 88,000 lives anticipates -- I'm trying to

13 think of the right word here -- an

14 expectation, really, that is not going to be

15 met, I mean, in 20 years.

16 So you are going to -- You are

17 sort of saying -- You are sort of suggesting

18 that we are going to accomplish something that

19 isn't going to be accomplished by sort of

20 focusing on this national estimate of a number

21 down to --

22 DR. PEKAR: Well, let me just be

Page 185

1 clear. You know, we certainly are not saying

2 that we are going to save all 88,000. That is

3 saying that is the public health impact of

4 current PM2.5 exposures.

5 You know, clearly, if we did model

6 alternate standard levels, we are not going to

7 pull the entire country down to 5.8. If you

8 could reduce the entire country to the LML,

9 then that is essentially what it is saying,

10 but clearly, if we are talking about a

11 standard level of ranges of 10, 12, 13, 14,

12 whatever, then you are leaving a huge chunk of

13 that 88,000 on the table. So just to be

14 clear, and we should certainly clarify that is

15 not the case.

16 CHAIRMAN SAMET: So do others want

17 to comment on this? I am going to take your -

18 - I think Frank's concern is that you are

19 putting out a big target that is not really

20 the ultimate goal -- I suppose it is the

21 ultimate goal for prevention, but not through

22 the strategies that are going to be laid out
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1 in the policy analysis, and there the analysis

2 is based on the findings of the 15 cities.

3 So I guess your question -- this

4 is sort of background motivation and such?

5 DR. SPEIZER: Yes, and I guess I

6 am concerned how this number is going to get

7 used. By putting it out there this way, it is

8 anticipating an unrealistic expectation.

9 CHAIRMAN SAMET: Yes. Joe?

10 DR. BRAIN: I share that concern,

11 and it seems to me it invites criticism and

12 attack. For me, it echoes a little bit some

13 of the things in Chapter 6 where it talks

14 about scenarios which produce 100 percent

15 reduction in risk. You know, I guess I do

16 sort of see where that came from, but it

17 really implies a threshold, a nonlinear dose

18 response curve which I think will be open to

19 criticism. 

20 You know, whether these modest

21 reductions can really produce 100 percent

22 reduction in risk -- you know, I find that

Page 187

1 sort of troubling, and it seems to me it is

2 sort of putting up this sign on your back,

3 "Kick me." I worry about it like Frank does.

4 CHAIRMAN SAMET: Well, it lacks

5 the careful uncertainty analyses that come

6 along with the rest of the risk assessment as

7 well. So I guess the question is: Putting

8 this in, in a somewhat --

9 DR. PEKAR: Can I just add

10 something about that 100 percent risk

11 reduction? I think this is a terminology

12 issue that we -- in the way that we describe

13 what was done.

14 All that is happening is we are

15 simulating the reduction in ambient air levels

16 down to 5.8.

17 CHAIRMAN SAMET: Right.

18 DR. PEKAR: Which is that LML. So

19 because we only calculated risk down to that

20 LML, if you get the annual average for a city

21 down to 5.8, you have zero calculated risk

22 within the range that we were calculating

Page 188

1 risk. But, clearly, I think, as I think about

2 it, it is ridiculous to have that statement of

3 100 percent reduction. You know, we are no

4 longer -- We are down to a level, annual

5 average level, below which we didn't calculate

6 risk for the purposes of this analysis, but it

7 is clearly not a 100 percent risk reduction,

8 and I think --

9 DR. BRAIN: No, I think you have

10 explained it well, and even in the document I

11 understood that reasoning, but I came with the

12 same conclusion, is that it is very dangerous

13 to talk about 100 percent reduction. It

14 really implies a kind of biology, epidemiology

15 that hardly anybody -- that no one would agree

16 with.

17 DR. PEKAR: My energy is aimed at

18 ourselves here, myself. That is something we

19 should, I think, have foreseen maybe a little

20 bit. So, yes.

21 DR. HUBBELL: So let me just

22 clarify a little bit about the need for doing

Page 189

1 a national scale assessment, because I think

2 that is one of the questions.

3 We certainly pushed on this,

4 because we are getting -- We get a lot of

5 comments and a lot of questions about, well,

6 what is the national burden of risk associated

7 with PM, not with the standard but with PM as

8 it exists today, and we get a question of how

9 well the studies -- or the cities that we have

10 looked at in the risk assessment represent the

11 overall burden of risk throughout the country.

12 So there's two purposes in doing

13 this. One was to get an idea of the overall

14 context of risk within a nationwide risk

15 attribution study. 

16 The second was to be able to place

17 the individual cities and identify whether

18 those cities fall within the upper range or

19 the lower range of mortality estimates by

20 looking at the distribution of mortality

21 throughout the U.S.

22 I think we accomplished both of
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1 those things, but let me point out that,

2 again, all we are doing when we provide that

3 88,000 number is we are applying what the ISA

4 says, which is look at a log linear non5 threshold relationship as the best

6 representation of PM risk, and we are applying

7 that to existing concentrations that we have

8 modeled throughout the country.

9 So if there is a problem with the

10 ISA and its interpretation of what the

11 concentration-response relationship looks

12 like, that is where your comments should go,

13 not to the application and national risk

14 context.

15 This is simply the logical

16 extension of those results, and this is

17 consistent with what is being done in a number

18 of other situations, such as the Global Burden

19 of Disease Study that is being put out by WHO. 

20 It is what is done in a number of other risk

21 attribution studies where in Europe and other

22 places where people have gone down to lowest

Page 191

1 observed levels in studies.

2 So it is just a natural extension

3 of the risk literature, and it is not really

4 doing anything different than what you are

5 seeing in other studies. The numbers look

6 big, but guess what. People are exposed to a

7 lot of PM, and that is the implication. 

8 Again, these studies -- the ACS

9 study and the Harvard study, they estimate

10 somewhere between six and 15 percent risk per

11 -- I mean odds ratios of 1.06 to 1.15 for a 10

12 microgram change. If you are exposing people

13 to a 10 micrograms of PM, that is the percent

14 of mortality you would expect. 

15 So these numbers are big, but they

16 are not relatively big compared to what the

17 studies are telling you.

18 CHAIRMAN SAMET: Helen?

19 DR. SUH: Actually, I do see the

20 benefit of something like this. I guess, for

21 me, there was a little bit of a disconnect,

22 because it does rely on CMAQ as well as a lot

Page 192

1 of modeling, where a lot of the premise that

2 was set up in the Chapter 3 for how decisions

3 were made are based on measurement and based

4 on actual data.

5 One of the things that is great

6 about this figure, for example, that is shown

7 is that it is based on measurements of what

8 the numbers might be. So in some ways, this

9 chapter is a little bit of a sidestep or it

10 seems to go against some of the requirements

11 set up earlier, which are really -- they

12 should be measurement based.

13 So I guess that is what I --

14 originally what I thought what Frank was

15 getting at, is that it seems a little bit not

16 really fitting with the overall concept of the

17 risk assessment. 

18 So I understand the purpose of it

19 and everything. I guess the problem is that

20 it doesn't really fit in this document, which

21 was set up, really, based on actual numbers,

22 not that the models have different numbers,

Page 193

1 but it is set up in a totally different way

2 than the whole prelude to it.

3 So I guess that is why I thought

4 maybe Frank was setting it up sort of as an

5 appendices or something like that rather than

6 the Chapter 5, but I understand now that we

7 are slightly coming at it from different

8 vantage points, but I guess I thought it

9 didn't really quite fit with the whole prelude

10 to it.

11 CHAIRMAN SAMET: So I think there

12 are a few points. One is, obviously, you can

13 make these calculations, and you have done it. 

14 Second, in terms of, for example, the global

15 burden of disease and allergy, what I see here

16 is a sort of a counter-factual of convenience

17 that doesn't make any particular sense. It

18 happens to be the lowest measured level in a

19 set of studies, and I am not sure why you

20 would necessarily even pick that.

21 There is substantial more reason

22 in the global burden about what is, in fact,
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1 the basis for the comparison.

2 I think probably -- I think, more

3 importantly, is whether this presentation of

4 the model, which I think departs substantially

5 from the care and rigor with everything that

6 has been presented before, in a way detracts

7 from both the risk exposure assessment itself

8 and from Chapter 5.

9 Then probably the last point, most

10 importantly, is these numbers analyses are not

11 going to figure into the policy analysis, if

12 I understand the general approach. I am

13 correct on that. 

14 So then in terms of sort of

15 setting out the process by which you are going

16 to go from sort of the ISA on to and into the

17 policy analysis and the recommendations to the

18 Administrator, maybe Frank has, I think,

19 wisely directed us to think carefully about

20 whether this helps or not, because it sort of

21 doesn't belong in the flow of logic and

22 analysis that is going to go from scientific

Page 195

1 evidence in the end to policy recommendations,

2 except to say, gee, there is a really big

3 target out there, however you go after trying

4 to assess it.

5 DR. MARTIN: If I could just make

6 a point about the relevance of this, the

7 information in this chapter, to thinking about

8 the policy assessment.

9 One thing -- and Bryan talked

10 about two purposes that this analysis serves. 

11 The second purpose served the purpose of

12 addressing the question: When we look at the

13 risks estimated in the 15 cities we selected

14 to do more rigorous analysis of, where do

15 those risk estimates fit in the context of

16 risks that likely are occurring in cities

17 across the U.S.? Are we truly capturing the

18 high end of risk cities? Are we distributed

19 across the upper part of the distribution, et

20 cetera, et cetera?

21 And that does help provide

22 context. Even if the comparison is only made

Page 196

1 for risk associated with current levels of air

2 quality, it still provides a frame of

3 reference, and from that point of view, I

4 think it does help inform from a policy

5 assessment perspective our interpretation of

6 have we truly captured the upper end of the

7 distribution of cities with relative to PM

8 risk levels.

9 For that purpose, however, the

10 analysis could, of course, be put in an

11 appendix, and that aspect of it could be drawn

12 out in conjunction with the other types of

13 representativeness analyses that are presented

14 for different kinds of risk related

15 parameters.

16 DR. SUH: Alternatively, you could

17 also just use the measurements data for other

18 cities, and use that instead of using the

19 modeling data.

20 DR. MARTIN: You could use air

21 quality measurement data.

22 DR. SUH: Right.

Page 197

1 DR. MARTIN: But that doesn't give

2 you the translation into a risk metric at all.

3 DR. HUBBELL: Let me be clear on

4 that. The reason why you can't simply do that

5 is that some of the differences were driven

6 not by the PM levels but by differences in

7 baseline mortality rates, by the composition

8 of the population, and by other factors that

9 affect the risk metric.

10 DR. SUH: But that is true,

11 regardless of the CMAQ model. That holds for

12 everything.

13 DR. HUBBELL: Right, but --

14 DR. SUH: I mean, I think using

15 the measurement, the models have the same

16 problems -- right? -- in terms of trying to

17 extrapolate to the -- I mean, even comparing

18 one of the 15 cities to another of the 15

19 cities, there are the same problems. Right? 

20 Because you have different demographics,

21 different attribution, different --

22 DR. HUBBELL: But you can build
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1 those in, and that is what -- These risk

2 estimates build all that in. They use

3 databases that have county level mortality

4 baseline incidence rates, different

5 demographics for the different grid cells

6 throughout the U.S. So it combines that

7 information to come up with overall risk

8 estimates.

9 In other words, not just where the

10 PM is, but is the PM in the same places where

11 centers of populations exist?

12 DR. MARTIN: And that is what you

13 are getting from applying the BenMAP model.

14 DR. HUBBELL: It is not just CMAQ

15 air quality data. It is combined with the

16 other information.

17 CHAIRMAN SAMET: Ed?

18 MR. AVOL: I think that this -- I

19 think particularly this figure was useful and

20 contributed. The other parts, I thought, were

21 a little thin around it in terms of how it was

22 integrated into where the direction of the

Page 199

1 risk assessment was going in terms of building

2 the case. But this, I think, is important to

3 being a part of why those 15 cities do fit in.

4 I could go either way. I could

5 say that this could be pulled back into

6 appendix, but this maybe ought to be a part of

7 the previous chapter justification as to how

8 you get these 15 cities and what you do with

9 them.

10 CHAIRMAN SAMET: Frank, I am going

11 to go back to you. We have discussed this. 

12 If you were going to write your comments to

13 Charge Question 5.5 or whatever, what would

14 you say right now, or recommend?

15 DR. SPEIZER: I guess I still

16 would think this probably belongs in appendix

17 or an accompanying document that talks about

18 what this risk assessment does when you apply

19 it to a global burden or global burden of the

20 U.S., almost a separate document rather than

21 having it in this one.

22 CHAIRMAN SAMET: And, I guess,

Page 200

1 back to Ed, Figure 5.4 in a sense would be

2 useful as part of the discussion in Chapter 6,

3 for example -- could be. I think that was

4 your point, and maybe if that is really what

5 you want, that a way to do this would be

6 perhaps to relegate the limited analysis of

7 Chapter 5 to an appendix and have that figure

8 or something you want to pull forward, just to

9 present these communities in some sort of risk

10 distribution, which seems to be what you want

11 to do.

12 Then I think the -- and then you

13 can say that you have done it for that

14 purpose, and not to do a more detailed risk

15 assessment that, I think, would require, if we

16 are really going to be representative, a

17 probably more complete analysis of

18 uncertainty. 

19 I am sure you could do some of

20 that, but there is not probably time or

21 necessity, if the main purpose is to have

22 something like Figure 5.4. I think that is

Page 201

1 what you said you wanted. I think, Karen,

2 that was your comment.

3 DR. MARTIN: Yes.

4 DR. HUBBELL: If we are to move

5 forward on this as we develop the final

6 version, the question becomes --There was some

7 question about we haven't done as many

8 sensitivity analyses, all these other things.

9 One part of it is that, obviously,

10 the air quality modeling or the exposure

11 surface part -- It is as simple to do a

12 sensitivity like a peak shaving versus a

13 proportional, because we are not looking at

14 rollbacks. We are just looking at ways of

15 integrating air quality data. So that

16 particular aspect of it is harder to work

17 with.

18 In terms of the one based on CR

19 functions, the implications are going to be

20 exactly the same as for the 15 cities. So

21 doing those would be possible, but I am not

22 sure what insights you would gain.
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1 CHAIRMAN SAMET: Well, I think, if

2 your major point is to have something like

3 Figure 5.4, this can be relatively invariant

4 with choice of -- It will be invariant with

5 choice of concentration response function, I

6 think. 

7 Then probably what you could do is

8 take Chapter 5 and put it there and say, look,

9 we wanted to be able to line up these

10 communities in a broader distribution of risk. 

11 We have done an analysis using BenMAP. Our

12 purpose was not to fully characterize

13 uncertainties, et cetera, and end up with

14 something like Figure 5.4, and then pull that

15 into Chapter 6 maybe. Then Frank will be

16 happy. Sverre won't.

17 DR. VEDAL: I'm happy.

18 CHAIRMAN SAMET: He is happy.

19 Okay.

20 DR. HUBBELL: So in that case, we

21 wouldn't necessarily need to expand that

22 appendix to cover these other aspects.

Page 203

1 CHAIRMAN SAMET: I don't think so. 

2 I don't think so. No, I don't think so at

3 all.

4 DR. HUBBELL: I am just making

5 sure that is not an expectation.

6 CHAIRMAN SAMET: No. Just when

7 you do it, then we will say it was an

8 expectation. No. Just say very carefully why

9 you are not doing it, and that to your purpose

10 it is not important.

11 Maybe we shouldn't launch into

12 Charge Question 6, because that will take a

13 while, and perhaps break for lunch. 

14 Frank, will you write up something

15 additional for Chapter 5. Between the two of

16 us, we can do it.

17 What I would suggest is that we

18 break for lunch, maybe get back about quarter

19 after one, and then we could do Charge

20 Question 6, and I think then what we would

21 probably like to do is go to the visibility,

22 if you could have your full team here then.

Page 204

1 DR. MARTIN: Probably around 2:30?

2 CHAIRMAN SAMET: I think it will

3 take us probably at least 45 minutes to

4 discuss Charge Question 6. So let's maybe aim

5 for two, and then see. Okay 

6 So let's break for about an hour

7 now until 1:15.

8 (Whereupon, the above-entitled

9 matter went off the record at 12:18 p.m. and

10 resumed a 1:21 p.m.)

11 

12

13

14

15

16

17

18

19

20

21

22

Page 205

1 A F T E R N O O N S E S S I O N

2 (1:21 p.m.)

3 CHAIRMAN SAMET: We are going to

4 get started. We are back to Charge Question

5 6, and Frank, this is you as the leader. So

6 Charge 6a-e.

7 DR. SPEIZER: All right. Well,

8 several people have commented on this, and I

9 will hope that they will chime in and fight

10 with me, if I say some things crazy.

11 In general, I thought this was a

12 very good chapter, and indeed I think it

13 pulled together things reasonably well. I

14 would have liked to have seen it more

15 conclusively coming to billets, but maybe that

16 is what the PA is for.

17 I think it -- There was concern

18 going in that I thought ought to be somewhere

19 in this document, which was a even tentative

20 risk assessment on PM10-2.5, rather than just

21 a promissory note that it would be discussed

22 in the next document.
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1 Fortunately, with the discussion

2 this morning, we did see that there is a

3 chapter in the coming PA document. I just

4 wanted to be sure that there was something

5 that made sure we got there. 

6 So several of my comments

7 throughout my review sort of was pushing on

8 the issue that they should do something with

9 10-2.5, and hopefully, they have now done it. 

10 I haven't had a chance to read the new

11 document, but hopefully, it is there, because

12 I think it is important that there be a pretty

13 thorough, even though qualitative, discussion

14 of it.

15 With regard to the specific charge

16 questions, I guess the only comment that I

17 have for the first one, a, with regard to the

18 key policy issue, was to make sure that coarse

19 particles got included. So I guess that is

20 taken care of.

21 With regard to b, the relative

22 contributions of the 24-hour design value and

Page 207

1 the peak, we have discussed this at some level

2 already, and I think I understand -- I

3 understand, certainly, better what the peak

4 rollback is doing now. It may need some more

5 general text added as to how the distributions

6 were determined.

7 There is concern, I think, about

8 the -- at least some concern about the uneven

9 distributions between the 15 urban sites. Now

10 maybe somewhere along the way there needs to

11 be a baseline figure -- a baseline level of

12 what the mortality rates are in these cities

13 from which you are working from, because they

14 really are quite variable.

15 I know that gets incorporated in

16 the analysis, but intuitively it is hard to

17 see when you see these ranges of percent

18 changes whether you are dealing from very low

19 rates or very high rates, and potentially what

20 the variability is around those rates.

21 So I am not sure how that should

22 be handled, but the estimates are really quite

Page 208

1 different from some of the different places,

2 and I think there might be some way to

3 incorporate that better.

4 In general, though, I think the

5 uncertainties and variability has been dealt

6 with reasonably well. Zach has explained to

7 me now that there is a difference between how

8 the national rates are calculated, from what

9 source. I guess the 15 urban sites are not

10 being used for that. So that is helpful, I

11 think.

12 I thought the key observations are

13 presented in a balanced and fair way. In

14 general, I think that the entire document --

15 chapter -- reads rather well, and does what it

16 is supposed to do, and I am glad it has been

17 added for this document. So I don't have a

18 lot more to say than that. Others may have

19 some comments.

20 CHAIRMAN SAMET: Okay. Sverre?

21 DR. VEDAL: I thought this was a

22 welcome chapter to have. I thought -- one

Page 209

1 observation was I thought that for an

2 integrative summary, I thought it was a little

3 what I described as formulaic in some way

4 because, you know, you go through the parallel

5 description of what happened with just meeting

6 the standard and the parallel description of

7 what happened in the alternative standard.

8 It wasn't repetitive, because it

9 was new information, but it was pretty

10 formulaic for what is billed as an integrative

11 summary that is supposed to be a little bit,

12 perhaps, more thoughtful. Nevertheless, you

13 can get over that.

14 I made mention of the ischemic

15 heart disease issue as it relates to the

16 confidence section, which really, because of

17 the emphasis on ischemic heart disease, is

18 going to have to be -- that is going to have

19 to answer those confidence issue aspect,

20 because I think there is some less confidence

21 in that relative to cardiovascular mortality

22 totally, and that is not reflected in this.
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1 There is -- I hope it is a mistake

2 in one section where you are talking about PM

3 attributable effect of long term exposure on

4 total mortality. I think that should be --

5 and I have itemized it here -- I think that

6 should be IHD mortality? Oh, okay.

7 DR. PEKAR: That is right, yes.

8 DR. VEDAL: Yes. It sort of threw

9 me there for a while, and I was having

10 nightmares, but it turns out okay. It is a

11 problem that is easily rectified.

12 I think you are trying too hard to

13 justify the emphasis on long term means, and

14 by that I mean you have one section, and it is

15 on page 6.5, starts on line 3, where you have

16 this statement that short term exposure

17 related risk is also driven by changes in long

18 term average PM concentrations. I don't think

19 that is true.

20 I don't think it has anything to

21 do with long term PM concentrations. In fact,

22 it has been shown that they are pretty

Page 211

1 independent and, in fact, that the

2 concentration-response relationship may be

3 steeper at the lower -- for short term effects

4 may be lower at the -- I mean higher at the

5 lower long term concentration end.

6 So I wouldn't make that argument. 

7 You don't need to, and I think it is wrong.

8 DR. PEKAR: So if I can just close

9 that a little bit, you know, we are not saying

10 that there is an association between -- let me

11 approach it this way.

12 What we are essentially saying is,

13 given that the concentration response

14 functions we have for short term mortality or

15 morbidity, those are working on differences

16 and working on a reduction in risk. 

17 It is a delta for each day, and

18 really then the aggregate change that you see

19 if you add up the reduction exposure for each

20 day and you are applying the CR function to

21 each one of those little increments, the

22 greatest change in risk when you have a

Page 212

1 reduction -- when you reduce PM levels, PM2.5

2 levels, it is really the overall shift in the

3 distribution that has the greatest effect on

4 overall mortality, short term mortality, not

5 simply the shift in the highest peaks.

6 Now if there is strong non7 linearity, I would say that high --

8 DR. VEDAL: That is a different

9 point. That is saying that most of the oomph

10 of short term effects occurs lower down in the

11 distribution where most of the data is, and

12 there is no doubt about that. That is

13 happening. 

14 You can cut off all the high

15 concentration values, and you are still left

16 with a substantial effect, but it is still due

17 to these little changes. It has nothing to do

18 with the annual average and the long term

19 average where that is at. 

20 So those are two entirely

21 different points. Do you see that? 

22 DR. PEKAR: I do, but if you are

Page 213

1 talking about sort of an area -- the shift in

2 the curve, and if you take all those little

3 additional little small pieces we are talking

4 about, those equate to a shift in the mean, I

5 believe, in the way I am thinking about it.

6 DR. VEDAL: Whether those

7 perturbations are occurring at an annual

8 average of five versus 15 makes absolutely no

9 difference.

10 DR. PEKAR: That is true, so if

11 you talk about this --

12 DR. VEDAL: It is not driven by

13 long term average issues at all.

14 DR. PEKAR: So I guess what I am

15 trying -- I agree with you that the absolute -

16 - where that annual average is sitting in an

17 absolute sense has no bearing on it at all.

18 DR. VEDAL: Right.

19 DR. PEKAR: But the delta of the

20 annual average will track the change in those

21 little snippets, meaning if you go from, as an

22 annual average, 13 to 14 -- sorry from 14 to
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1 13 or from eight to seven, you can have that

2 same change in the annual mean, and you can

3 have that reflected in a series of snippets --

4 I am going to stop. 

5 I guess what I am saying is I

6 think you can consider a shift, an incremental

7 shift in the mean as being related to the

8 change in those individual daily deltas.

9 DR. VEDAL: My only point is -- I

10 mean, I wouldn't -- just wouldn't say it.

11 DR. PEKAR: I agree.

12 DR. VEDAL: You don't need to say

13 it --

14 DR. PEKAR: I agree.

15 DR. VEDAL: -- in making your

16 case.

17 A couple of other small things,

18 and maybe just one other small thing. It had

19 to do with this national context thing. I

20 think it may be an error as well.

21 It is this issue of what are the

22 15 cities supposed to -- what distribution is

Page 215

1 it supposed to reflect?

2 I think, if I understand the tone

3 of the rest of the document, they are supposed

4 to reflect basically cities out of compliance

5 or of the higher end of the air pollution

6 concentration spectrum.

7 I think, from that perspective,

8 they do, and that is clear from the figures

9 that we see, but there is a little place that

10 I itemized here where it says that where the

11 15 cities capture the overall distribution of

12 risk for the nation, which is not true. 

13 Right?

14 DR. PEKAR: Well, and I think that

15 is again a rating issue that we could work on. 

16 I think the national scale analysis that Bryan

17 was talking about earlier where we plotted the

18 counties in the nation, the mortality

19 estimates for the counties in the nation, and

20 then saw where the counties we had modeled

21 fell across those, and you could see that our

22 counties that we modeled fit the 15 urban

Page 216

1 study areas which are roughly 30-some

2 counties, in the 15 cities 30-some counties

3 fall across the upper end of that national

4 distribution of risk. I think that is where

5 that statement comes from.

6 It certainly represents areas with

7 higher ambient levels, but then when you

8 consider baseline incidence and other things

9 that are nicely considered in that BenMAP

10 modeling of risk, and you see where our

11 counties fall across, that is where that

12 statement comes from.

13 DR. VEDAL: Maybe just a little

14 bit of something to make that point a little

15 clearer, because it just sort of set off a

16 little alarm bell for me. I mean, that wasn't

17 the intent. I think the way I interpreted it

18 was clearly not what the intent of the way

19 those cities were used.

20 DR. PEKAR: Right. Well, we can

21 certainly -- if I make a statement -- if we

22 make a statement like that, what are we

Page 217

1 pointing to and basing that on -- sort of

2 generally.

3 DR. VEDAL: And then I cut bait

4 on the issue of whether I thought there was

5 any utility in estimating below 12, and I said

6 no. That's it.

7 DR. PEKAR: We are definitely

8 hoping -- well, that will come up later, I

9 guess, but just that we have a little more

10 discussion on that very point, I think.

11 CHAIRMAN SAMET: We will certainly

12 be discussing that in the policy analysis.

13 Let's see. Joe?

14 DR. BRAIN: I also had a positive

15 response to it, and answered yes to many of

16 the charge questions rather easily.

17 I still found the whole chapter,

18 number one, very important, but dense and

19 complex. I mean, there were just so many

20 sentences that I had to sort of read twice. 

21 There were long, lots of qualifying clauses. 

22 So I think somehow, if it could be made
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1 clearer and tighter and shorter, it would be

2 a good idea.

3 It also seemed to me it dealt more

4 with the caveats with the uncertainties and

5 the sensitivity analysis. So you were very

6 clear about the uncertainties. I would like

7 you to be clearer about the certainties and

8 sort of highlight what are some of the clear

9 conclusions.

10 Again, adjacent to what you just

11 heard, I was also interested in the 15 cities,

12 and we have talked about clarifying what they

13 represent and where they are in the

14 distribution, and it did sort of raise the

15 question, in addition to clarity about where

16 these 15 cities are, should you sometime look

17 at 15 cities that do represent the

18 demographics of the United States. 

19 Is it important -- so this is, I

20 guess, the question: Is it important to know

21 how different standards would affect the

22 cities in the bottom half? Is that important

Page 219

1 to know, if you were making a decision. So I

2 guess that is kind of a real question: Do we

3 need to understand better the cities that are

4 more in compliance, and is that part of the

5 overall assessment for the whole country?

6 Then I think I have already

7 mentioned my concern about the conclusion of

8 100 percent reduction in risk, which raises

9 issues. 

10 It sounds like it really reflects

11 the absence of data, which shouldn't be

12 equated to the absence of effects, because on

13 the one hand, we are also saying we are not

14 really aware of any threshold, again given the

15 broad range of sensitivity, that there are

16 some people that are so sensitive that it is

17 hard to find a level of PM that will not

18 affect them. So it seems to me, somehow that

19 needs to be fixed, because that sort of, to

20 me, raises flags and raises questions about

21 the credibility of the whole analysis.

22 Otherwise, I think it is really

Page 220

1 coming along, and lots of things to applaud.

2 CHAIRMAN SAMET: Thanks, Joe. 

3 Mort?

4 DR. LIPPMANN: I haven't got much

5 to add. I agree that it is a little

6 formulaic, but I mean, that is what we are

7 supposed to be looking at, whether each of

8 these pieces makes sense on its own; and

9 considering the amount of work overall that

10 had to be done, polishing it and making it

11 shorter is probably the hardest part, and

12 there wasn't time to do that.

13 I had one -- I read it carefully,

14 but I couldn't find much to complain about

15 except on page 618 there are statements on

16 line 15 and again on 21 that estimates were

17 also developed for other effects. But I

18 didn't see that such estimates were described.

19 So I wonder why -- I mean, either

20 you cite where such estimates can be found for

21 the curious, which is me, or don't say it at

22 all. Were these estimates in the document

Page 221

1 anyplace?

2 DR. PEKAR: Yes. So part of what

3 we were facing -- the last version of the

4 document, one of the criticisms, and I think

5 it was a good one, was that the summary of the

6 risk results -- let me start with an answer to

7 your question.

8 Yes, we did run them, and they are

9 available, but in the last version in full

10 when we described the risk results, we

11 included summaries of all of the categories of

12 mortality modeled, and that description was

13 really, really long and very, very tough for

14 all of us to wade through.

15 So for this analysis, we shortened

16 it and focused it on the cardiovascular

17 categories. In the appendix you still have

18 all of the results for all of these. So --

19 DR. LIPPMANN: Then all it needs

20 is a reference to where in the appendix we can

21 find it, so that if anybody does want it, it

22 is available. But looking at this document,
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1 stand-alone, I didn't know where it was.

2 DR. PEKAR: In 4, we point that

3 out pretty clearly, but I think it has been a

4 while by the time you get to this, since 4. 

5 So I think having some footnotes to clarify

6 that -- we can definitely do that.

7 DR. LIPPMANN: Okay. Then

8 apparently we have some difference of opinion

9 emerging already among the Panel about your

10 question, should we be looking below 12

11 micrograms per cubic meter. 

12 Here, I wonder, in taking a sneak

13 peek at the draft policy assessment, about the

14 statement that alternative levels at -- what?

15 -- 10 or 11 will be considered. That is not

16 in this document, this risk assessment

17 document, but the policy document presumably

18 is going to extrapolate and extract

19 conclusions from the risk assessment document.

20 So perhaps it is not kosher to

21 talk about the policy assessment document yet,

22 but it certainly sent up a flag to me when I

Page 223

1 saw that levels below 12 were going to be

2 considered in a policy sense. So it makes it

3 important for CASAC to say what it chooses to

4 say about extrapolating below 12 from a

5 scientifically justifiable perspective.

6 Now again it is a little bit

7 beyond the framework we are supposed to be

8 acting, but I can certainly sympathize, as I

9 think people listening to my comments over

10 this document and over the years about PM long

11 term concentration NAAQS. 

12 I was pretty vigorous in saying

13 that 15 wasn't protective and that it had to

14 go lower, and last round we hoped it would be

15 13 or 14, and it wasn't, and there is a lot

16 more justification for considering 12.

17 I don't see how everything that is

18 in the ISA and the risk assessment justifies

19 talking about something lower than 12, even if

20 it was scientifically warranted. Furthermore,

21 being an engineer by background, I can't

22 imagine changing -- that is complying with

Page 224

1 something below 12 for the foreseeable

2 decades, let alone years, unless we radically

3 change everything about the way we do

4 business.

5 So why should we at this point for

6 this round be considering something below 12? 

7 Twelve would be not fully protective, I grant

8 you, from my understanding of the science not

9 fully protective, but on the other hand,

10 something lower than that is beyond the realm

11 of physical possibility, as far as I can see.

12 So I wonder how we are supposed to

13 respond to that last charge question.

14 DR. BRAIN: In fact, I would just

15 add, you know, the last sentence in the last

16 charge question is quite clear. Do you

17 believe there is utility in estimating risk

18 for standards below 12 micrograms, and if you

19 looked at all the individual comments,

20 everybody said no. So I would just add that.

21 I guess we are not supposed to

22 consider whether it is achievable or not. 

Page 225

1 Right?

2 DR. LIPPMANN: We are not supposed

3 to, but we live in the real world.

4 DR. MARTIN: Well, but we also put

5 forward -- the agency puts forward its

6 decisions on standard in the real world, too,

7 and the real world requires that we be able to

8 legally defend the basis for our decisions;

9 and if the science takes us somewhere that we

10 all have intuitions would be very difficult to

11 meet, the Act doesn't give us any leave to

12 consider that.

13 So as part of living in our real

14 world as a regulatory agency, we can only base

15 decisions on what we are allowed to base

16 decisions on. I would encourage you to think

17 about, as you read the policy assessment in

18 the days and weeks to come and ponder over

19 what is there, to the extent that when we meet

20 in April we have discussions that highlight

21 reasons why translating the science into

22 standard levels doesn't get you to that lower
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1 range, then I think that is a really valid

2 discussion for us to have. But I encourage

3 you to think about the reasons for your views

4 on this in terms other than considering when

5 in the future we might possibly be able to get

6 there. 

7 It just won't work for us as a

8 rationale, and we need to think about how to

9 interpret the science in an objective way

10 here.

11 DR. LIPPMANN: Well, science is a

12 very broad term. Science includes technology,

13 as far as I am concerned, and if there is no

14 technology to take us where we would like to

15 go in terms of public health protection, that

16 is a realistic concern, and of course, I think

17 it leaves the agency vulnerable to serious

18 criticism in Congress and other venues when

19 something that is extremely unlikely to be

20 achievable is put into a regulation.

21 So we presumably will be back in

22 five years, now that the schedule is getting

Page 227

1 closer to the intention of the Act, and it

2 used to be 10 years between standard setting,

3 and it is approaching something closer to the

4 target of five years. By that time, in my

5 view, with the agency doing what it needs to

6 do with improved monitoring we may be able --

7 we should be able to get the past mass-based

8 NAAQS.

9 Then in terms of achieving a

10 public health protection, putting in standards

11 based on the more toxic components is more

12 achievable within what the country can afford. 

13 So I think we are getting into a situation

14 where mass-based standards are being taken far

15 beyond where they are reasonable to go when we

16 talk about something below 12.

17 DR. MARTIN: I do feel a need to

18 just react again. If your premise is that the

19 uncertainties associated with the potential

20 for differential toxicity in components in the

21 aggregate mass of fine particles is such that

22 you think it is unjustified to put weight on

Page 228

1 studies that look only at aggregated PM2.5

2 mass at these lower levels, that is a line of

3 reasoning I can understand and relate to an

4 interpretation of the science.

5 If your point of view is we

6 shouldn't go there, because we don't think we

7 can attain it, that is a line of reasoning

8 that simply cannot be part of the rationale

9 that the agency considers. 

10 Without belaboring the point, and

11 I am sure I am belaboring the point, that is

12 the only way I know how to characterize my

13 reaction to the nature of the discussion here.

14 DR. LIPPMANN: As always, Karen

15 comes up with exactly the right wording. So

16 what I was leading to was that alternative,

17 that taking mass beyond where it should go is

18 not scientifically justifiable, and that by

19 setting up what needs to be done in the next

20 few years so as to get us past that point so

21 that scientific justifications can be made

22 with more confidence based on something other

Page 229

1 than mass, then the uncertainty is the handle

2 on which to go there.

3 I think I have said enough.

4 CHAIRMAN SAMET: Frank?

5 DR. SPEIZER: Well, I wanted to

6 sort of again belabor the point a little bit,

7 because I actually was convinced by Karen that

8 we do have to do what she is suggesting, which

9 changes my conclusion originally, too, which

10 was that we wouldn't go there; because indeed,

11 if we take the sort of three components, no

12 threshold as far as we know, a linear dose

13 response, and a potential for a margin of

14 safety, I think she has to go down. She has

15 to go down, and she has to make these

16 calculations.

17 Now once they are made, then I

18 think the argument comes up as to we have to

19 deal with the uncertainties of what that

20 measurement is telling us. It is at that

21 point where I think your argument comes in. 

22 But I think she is, by law -- we are, by law,
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1 having to look at those numbers, because that

2 is what the law tells us we are supposed to

3 do.

4 DR. LIPPMANN: You are perfectly

5 logical, Frank, and the question is can we

6 finalize this risk assessment when there is no

7 extrapolation below 12, and the policy

8 document may be dealing with numbers that low.

9 DR. PEKAR: Can I just clarify one

10 point very quickly? In the introduction I

11 presented those preliminary analyses for 10. 

12 So we have conducted risk -- I mean, they are

13 preliminary. We haven't QA'ed them fully and

14 everything, but those runs are there.

15 In a sense, at least my personal

16 opinion was we were really wanting to get

17 CASAC's feedback on confidence in running

18 those estimates, but those analyses have been

19 run. So we have analyses. They are not

20 summarized in the risk assessment, but they

21 would be available for the final version. So

22 just to be clear.

Page 231

1 DR. LIPPMANN: The final version

2 of the risk assessment?

3 DR. PEKAR: Yes. 

4 CHAIRMAN SAMET: But just as a

5 comment -- and this does come up in the

6 discussion in the policy assessment. The

7 question of uncertainty does come in as you go

8 lower, and that is, in fact, discussed in the

9 policy assessment.

10 I think, in some ways, with an

11 argument that I don't particularly like that

12 we had seen before, and that is that, of

13 course, as you go to lower and lower end on

14 the concentration response curve, confidence

15 intervals widen and we are less sure about

16 what we have got. 

17 Well, it is a necessarily trivial

18 observation, and I am not sure that is exactly

19 the reason you don't go lower, but if we say

20 and make the guidance that, in fact, as you go

21 lower, there is mounting uncertainty about

22 what both the form and nature of the

Page 232

1 relationship is, it does become reasonable on

2 a scientific ground to say, well, at some

3 point it is not justifiable to continue to

4 extend the straight line or whatever

5 alternatives there are, because we are not

6 sufficiently certain.

7 I think we could make the

8 argument, Frank, going back that, for now, the

9 science justifies going down to, you know,

10 somewhere in the range, and we would have to

11 decide what points that is, of exposures at

12 which these concentration response functions

13 have been estimated and say, well, it is

14 reasonable to estimate down, putting aside

15 sort of whether it is issues of control

16 practicality or just sounding silly, that

17 since we have assumed a linear dose response

18 relationship; therefore, if you are going to

19 protect public health, you have to go to as

20 low as you can go. 

21 That becomes -- I mean, I

22 understand how you can get there, and I think

Page 233

1 that was sort of in your logic.

2 DR. SPEIZER: Yes. The question

3 is can we come up with a set of criteria where

4 it becomes irrational to go any lower, and

5 irrational from a scientific perspective.

6 Now if we go to 10, that is one

7 thing, but maybe you should go to seven and a

8 half. I don't know what the answer is. The

9 question is: Is there a way of looking at the

10 data that is generated to look at what the

11 deltas are at these lower levels, taking into

12 account the confidence intervals, and at some

13 point saying this is just noise?

14 CHAIRMAN SAMET: Yes, or we don't

15 know where we are, and these are questions

16 that have to be addressed by an understanding

17 of mechanisms and trying to then determine

18 what is the right concentration response

19 function; because we know that epidemiological

20 observations are not going to sort this out

21 with any precision or certainty as we go lower

22 and lower. Sverre?
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1 DR. VEDAL: Yes. I have a bit of

2 a different perspective on the annual

3 standard, which may help, may not.

4 Last time when we argued this and

5 we were arguing about whether we needed

6 something in addition to a more stringent 24-

7 hour standard, Mort made the argument -- it

8 was a good argument -- that we have cities

9 that fly under the radar with not a lot of

10 peakiness, annual averages that are low, and

11 yet and aren't captured by the 24-hour

12 standard.

13 That is not the case now. If you

14 look at those really nice figures that we

15 have, when you lower the 24-hour standard,

16 there ain't nothing left, no cities around,

17 that you gain anything by lowering the annual

18 standard.

19 In addition to that, we have no

20 evidence that outside of 24-hour average peaks

21 and such -- we have no evidence that a

22 constant level of, say, 13 or 12 without any

Page 235

1 fluctuations has any adverse effect at all. 

2 We don't know that.

3 So you have to kind of make this

4 leap that there is something above and beyond

5 what you do to the 24-hour standard that has

6 any meaning, and we are on very, very thin

7 ice, very thin evidence, to say that.

8 DR. LIPPMANN: Well, that is a

9 different issue, whether you are talking about

10 --

11 DR. VEDAL: Well, that is a

12 science based issue, Mort. That has nothing

13 to do with feasibility.

14 DR. LIPPMANN: No, but the annual

15 average is a means of allowing variation from

16 day to day, and then the epi says at these

17 annual averages you are getting a linear

18 response in terms of mortality.

19 DR. VEDAL: Well, that is just a

20 measure of exposure of convenience that we use

21 an annual average --

22 DR. LIPPMANN: Well, sure.

Page 236

1 DR. VEDAL: For an observational

2 study like that. That says nothing about what

3 the concentrations of relevance are in terms

4 of time averaging.

5 DR. LIPPMANN: Right, but I mean,

6 it came up before earlier that there is a

7 difference roughly between east and west, much

8 higher coefficients in the east than in the

9 west, maybe Los Angeles excluded, but by and

10 large. 

11 We are dealing not only in

12 assuming that annual average is important. We

13 are assuming that particle mass is important. 

14 We are assuming that there is a distribution

15 of sensitivities. We are assuming a lot of

16 things. We are dealing with the need, faced

17 with probably the largest public health impact

18 of anything EPA deals with. 

19 I think we all agree that there is

20 excess mortality associated with PM. The

21 standards need to be set based on the

22 available scientific information we have, and

Page 237

1 so we don't have any choice but, seems to me,

2 to assist EPA in determining whether or not

3 the science they cite is credible and helping

4 them make administrative decisions on

5 standards.

6 Yes, you are raising a point that

7 we wish we had better information, but we wish

8 we had better information on a lot of things.

9 CHAIRMAN SAMET: Let's see. 

10 Rogene, you are our last commenter. I am

11 waiting for you to provide the wisdom that

12 will get us out of where we are.

13 DR. HENDERSON: No. When I first

14 read this, I confess to a knee jerk response

15 of, goodness, no, we don't know enough to go

16 below 12. But in thinking about it and all

17 this good discussion, what it is, we are in

18 this conundrum with a no threshold effect, and

19 so how low do you go?

20 If you can't say this is a no

21 effect level, it is really puzzling, and what

22 has been suggested is that, well, it gets too
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1 uncertain below that. But that is just kind

2 of a buzz word. We don't know.

3 So what I think we need to do is

4 advise the agency on how to develop criteria

5 by which you stop considerations of lower

6 levels, and those criteria should be

7 scientifically objective and reasonable

8 criteria.

9 I am picturing a graph. You know,

10 on the X axis we have these different levels

11 going lower and lower, and then we could have

12 some measure of our knowledge or lack of

13 knowledge plotted against that, so that it was

14 obvious, well, we don't need to go below this

15 level.

16 I was fearing that we have no

17 evidence that I know -- correct me if -- of

18 health effects at these lower levels, and if

19 we don't have that evidence and we are just

20 basing on extrapolations, I get queasy about

21 it. I don't feel as comfortable. 

22 If there is some evidence that

Page 239

1 under certain circumstances we can go to these

2 low levels and have an effect, well, that is

3 certainly one of the criteria. But I would

4 vote for developing criteria for where you go

5 and a threshold effects level response.

6 CHAIRMAN SAMET: So maybe -- and I

7 think I see the problem, and maybe there is

8 some -- the logic is reversed here, and Zach,

9 you can tell me if I am getting this wrong.

10 I see language that, in effect,

11 you are saying here are some alternative

12 scenarios for the NAAQS; therefore, we modeled

13 these alternative scenarios. I mean, that is,

14 in essence, how it reads now.

15 There is even sort of language to

16 that effect. So I think, regardless of

17 whether you go -- where you go, the stated

18 rationale for where you take the risk exposure

19 analysis should probably not be what you think

20 the suite of standards will be that you

21 propose, and maybe that -- and Rogene and

22 others have commented that you have some other

Page 240

1 rationale, whether it is, hopefully,

2 scientifically based and should be based in

3 how you have assessed the certainty of the

4 evidence available.

5 You know, you could have 100 

6 percent confidence in a linear exposure

7 response relationship, and then you go as low

8 as you go. On the other hand, I think we

9 would all say that there is some doubt as you

10 go lower and lower, and increasing doubt as to

11 the nature of that relationship, and

12 uncertainty would become very important. 

13 Don't ask me exactly where, but -- certainly,

14 there is more at eight or nine than at 16 or

15 17.

16 So maybe the problem is how you

17 have stated it. I can understand why you have

18 done it, but it doesn't -- you don't have a

19 stopping rule, I guess. I think that is the

20 problem. Helen?

21 DR. SUH: You know, I come at

22 this a little bit different from my background

Page 241

1 and exposure. I guess I thought, because of

2 the uncertainty or the lack of knowledge or

3 however it wants to be phrased about the

4 concentration response function, I guess I

5 thought the easy way to do it would be to go

6 and take the annual averages for the cities

7 and take some values for where you see the 10

8 percent annual average for the country, and

9 use that; because there is certainty in that.

10 There is certainty, much more

11 certainty, in terms of what the levels are

12 around the country, and use that as sort of

13 your low/how low do you go kind of level. 

14 So what are the annual averages

15 and take some percentage, the 10th percentile

16 or I don't know what you want to choose, and

17 use that to say that is as low as you go,

18 because that is where you have the

19 information, and that is where you have all

20 the measurements. So you could use that to

21 ground that discussion.

22 DR. MARTIN: Well, I will note
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1 that that is the type of discussion that

2 appears in the policy assessment in terms of

3 looking directly at the studies, the air

4 quality information in the studies and

5 thinking about what kind of statistics might

6 we draw from that to provide some guidance as

7 to where we might go from the perspective of

8 translating that evidence into the basis for

9 a standard.

10 I also think it is a very

11 separable question to ask the question, if you

12 are going to do a quantitative risk

13 assessment, how low is it reasonable to

14 project estimates of risk in terms of how far

15 are you prepared to move a distribution of air

16 quality and still have confidence that the

17 risks you estimate for it are sufficiently

18 credible that they are worth doing.

19 I really think that is a related

20 but a separate kind of question. We are

21 asking both of them, of course.

22 CHAIRMAN SAMET: And what we said

Page 243

1 is the technology should not be the stopping

2 rule. That was sort of back to the Mort

3 discussion. 

4 I think I would say that probably

5 your idea of what set of standards might be

6 proposed is probably not the right point for

7 stopping either, and that ideally I think

8 science's confidence in the risk estimates and

9 the general approach -- I mean the level of

10 confidence in the model should be what drives

11 things.

12 You know, initially it puts all

13 our assumptions to the test, you know, your

14 nice descriptors of mild, moderate, whatever,

15 degrees of uncertainty and so on, and I don't

16 know whether we should stop at this point and

17 say you need a better way to do it, and maybe

18 you want to go lower once you develop your

19 stopping -- your justification for stopping at

20 a particular point, or we can give you some

21 further guidance on what we think that point

22 might be.

Page 244

1 I suspect, if we sort of did a

2 quick poll, you would get varying opinions

3 with some saying 12 is low enough, and some

4 saying, you know, go lower. I don't know

5 where people would stop. Rogene?

6 DR. HENDERSON: To me, a

7 scientist, our contribution is to help them

8 figure out how to develop these criteria for

9 stopping, but where they stop is a policy

10 judgment, because -- 

11 CHAIRMAN SAMET: Well, I would

12 actually say where they stop is not the policy

13 judgment. Where they stop should be the

14 scientific judgment, because that is where you

15 saying there is sufficient uncertainty that

16 you can't inform the policy with the risk

17 assessment anymore, that you have crossed some

18 sort of boundary.

19 So I think, if you say I voted for

20 the linear model and continue to extend it to

21 lower, I mean, you are in a sense moving right

22 into -- directly into the policy implications. 

Page 245

1 If you say, well, you know, we have confidence

2 in the linear relationship within this range,

3 because it has been observed empirically in a

4 set of studies bracketing that range, then I

5 think you are okay.

6 DR. HENDERSON: But someone has --

7 in a non-threshold system, somebody has to

8 decide, okay, this is what we will accept. We

9 are accepting some risk. We don't want zero -

10 - I mean, we don't expect zero risk.

11 CHAIRMAN SAMET: Right.

12 DR. HENDERSON: Isn't that policy?

13 CHAIRMAN SAMET: But that is the

14 policy side.

15 DR. HOPKE: The policy judgment is

16 what is the adequate margin of safety.

17 CHAIRMAN SAMET: Right.

18 DR. HOPKE: And when is the margin

19 of safety adequate?

20 CHAIRMAN SAMET: But I think you

21 stop the risk assessment at the point where

22 you are no longer sufficiently certain on that
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1 because you feel like you can't inform the

2 policy further.

3 I think, in a sense, the stopping

4 rule lies in your trying to make that judgment

5 as to where confidence is lacking, but there

6 has to be, I think, in some way some sentences

7 in here that say it, and that is, I think, the

8 challenge to all of us to say how would you

9 write those sentences. How would we advise

10 you to write those sentences? Bob?

11 DR. PHALEN: A quick comment. 

12 From a dosimetry point of view, I am always

13 shocked at what these levels mean for lifetime

14 exposure, and if I crank in 10 micrograms per

15 cubic meter times 10 cubic meters a day -- and

16 if you want to double that to 20, go ahead --

17 for 80 years, I get something like

18 approximately a gram deposited in the lung

19 over 80 years with 20 percent deposition.

20 I don't remember what a cigarette

21 deposits. What is it? On the order of a

22 gram, something like that? So we are talking

Page 247

1 about extraordinarily low doses. 

2 So from a dosimetric point of

3 view, it kind of drives me nuts to think that

4 we have a scientific basis for demanding less

5 than a gram of deposition of material in the

6 lungs over 80 years.

7 DR. SPEIZER: I am not sure that

8 argument can be extended. I mean, you know,

9 bumble bees can't fly because their wings are

10 too small, and giraffes can't have hydrostatic

11 pressures too high in their heads. So you

12 can't get there from -- that way.

13 I'd like to go back to Rogene's

14 comment, and I don't know whether we can do

15 this or whether you can ask staff to do this,

16 but the idea of whether there are real studies

17 out there that at least suggest an effect at

18 those levels might be a way of determining a

19 stopping rule in the sense that, if indeed --

20 and I don't know whether it is one study or

21 two studies or five studies; it may be only

22 one or two studies at a given level that show

Page 248

1 an effect that is acceptable to the scientific

2 community by having been peer reviewed, et

3 cetera, et cetera, might be a way of picking

4 a stopping level for this.

5 Now how easy that is to do or how

6 difficult it is, I don't know.

7 DR. BRAIN: I also think, in

8 addition to more studies at that level showing

9 the risks of those, what we really need are

10 stopping studies. I mean, I am impressed with

11 now the beginning of more and more studies

12 which show the benefits of reducing air

13 pollution. It seems to me that would even be

14 more compelling to reduce it from ten to five

15 and document a benefit.

16 DR. SPEIZER: Yes. There aren't

17 many studies like that that show the impact.

18 CHAIRMAN SAMET: Phil.

19 DR. HOPKE: But as you get to

20 those lower, you are going to wind up with

21 more and more publication bias because you are

22 not going to see anything. You are going to

Page 249

1 have questionable power.

2 DR. SPEIZER: Well, I am not sure

3 you have to actually use those in a power way. 

4 They just, they become a -- yes, there are

5 effects at 7 1/2; therefore, that is as far as

6 we can go.

7 CHAIRMAN SAMET: Rich?

8 MR. POIROT: Oh, I was just

9 thinking that, at least to a certain extent,

10 some of this -- this issue is maybe

11 exacerbated by this new process. I don't

12 recall putting anywhere near this much

13 attention on the risk assessment in the last

14 review cycle.

15 It is a logical process from the

16 integrated science assessment to the risk

17 assessment to the policy assessment, but I

18 certainly know, for example, on the urban

19 visibility assessment, many of our comments on

20 the risk assessment are imagining what you are

21 going to do with it in terms of setting the

22 policy, and I think that is kind of what some
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1 of our comments right now are reflecting as

2 well, is that up until this point, other than

3 the airplane ride, we had no idea exactly

4 where you were going in terms of policy, and

5 there might be certain policy modifications to

6 things that were in the risk assessment,

7 cutting things off at 12 for other good

8 reasons.

9 So anyway, I am kind of blaming

10 the system, and think that there is an element

11 of that in there, and there was something

12 useful about the old process of being able to

13 see the staff paper and the policy

14 implications of it inching along a little bit

15 lagged with the science aspects, and just

16 thought was a beneficial aspect of the old

17 process, was my comment.

18 CHAIRMAN SAMET: I mean, in

19 theory, in the new process these are sort of,

20 quote, "independent steps" as you have

21 outlines of going from the left and your

22 research workshop over here to a NAAQS, and

Page 251

1 that, in fact, there is this integration of

2 the scientific evidence. There is the

3 development of a risk model that could be used

4 for looking at any number of scenarios or

5 levels of air quality.

6 In fact, the way you are doing the

7 risk and exposure assessment, it is inherently

8 looking forward to what the NAAQS might be and

9 thinking about it. We had this discussion

10 about the rollback. I mean, those are

11 different sort of control scenarios.

12 So it is a little bit mixed up,

13 but I would suggest that you may not -- I

14 don't think you are going to get quantitative

15 wisdom from us today. I don't think I am

16 going to poll and say eight, nine, ten, and

17 ask the group to vote because that is not the

18 right way to do it either.

19 I think the right way for you to

20 do this is, though, to say that, you know,

21 independent of policy options, in your view,

22 the uncertainty is sufficient in the range of

Page 252

1 blank to blank, that you did not go any lower. 

2 I think making that kind of statement, I think

3 you can justify it from what is there.

4 You reviewed all the evidence

5 there is. You know what range it has covered. 

6 You know what happens as you go lower, and you

7 also know that there is probably more and more

8 mechanistic uncertainty. You know,

9 considerations of dose become relevant. 

10 Considerations of clearance, repair processes,

11 and so on.

12 So I think you could write a

13 paragraph that says we went to blank, and

14 leave it at that. I think that is probably

15 the best advice you are going to get out of

16 this group at 2:15 on Wednesday. 

17 DR. PEKAR: You know, I think that

18 makes some sense. I think there are just a

19 couple of things, in listening to folks, that

20 I want to mention.

21 I think, in my mind, there might

22 be a difference. I am not saying there is,

Page 253

1 but I am still tossing this around in my mind,

2 between guidance on alternate standards that

3 you consider and how far down you are willing

4 to model risk.

5 So do you have a really clear

6 sense of being able to characterize the

7 magnitude or the presence of an effect to a

8 certain level? But then realizing that when

9 we model risk below that, if we stop modeling

10 risk at a certain point, we are essentially

11 assuming from the standpoint of calculating

12 risk that there is zero risk. I mean, you are

13 not --

14 CHAIRMAN SAMET: No, you are not

15 saying that. You are saying you don't know. 

16 You are saying you don't know, and I think

17 that is an important distinction.

18 DR. PEKAR: I agree, but from the

19 numerical standpoint, if you say we don't

20 know, so we are not going to calculate below

21 this, and you give me a total incidence

22 estimate -- I am just putting this on the
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1 table as a point to keep in mind. If we only

2 model down to a certain point and we have that

3 incidence estimate, we stop at LML or we stop

4 at nine or we go down to PRB, those have

5 pretty radical implications for the total

6 incidence estimates.

7 Just keep in mind that, if we stop

8 at a certain point because we are uncertain,

9 if you stop at that point, you are saying we

10 are uncertain, and we are not going to assess

11 anything. So rather than saying it could be

12 a linear, it could be -- I guess my point is

13 that in a sense, from a numerical standpoint,

14 you then are looking at a numerical threshold

15 in terms of your calculation.

16 That is just something to keep in

17 mind, and that may be a different point, the

18 nature of how far the CR function goes down

19 versus looking at a standard level of 12 and

20 calculating some risks below that, or 10 and

21 calculating risks below that. 

22 In my mind, those might be too --

Page 255

1 that might be a nuance. It might be

2 important. I am not sure, but just to put

3 that --

4 CHAIRMAN SAMET: You know, you

5 are far enough into the policy analysis to

6 know what you need. I think what you need

7 here is a reasoned basis for setting the lower

8 limit of where you are going.

9 DR. PEKAR: Yes.

10 CHAIRMAN SAMET: And I think that

11 is really what you need. So maybe -- I think

12 this has been a useful discussion. I think it

13 has helped us all realize how challenging this

14 is. Are there other comments on Charge

15 Question 6, integrative -- I will say that I

16 think a number of people made comments about

17 the writing, and I don't know who drafted

18 this, but since this will be so much read and

19 it is so important, it just really needs some

20 attention.

21 There is some masterfully bad

22 writing in it. Sorry. And I think that it

Page 256

1 just needs to be carefully fixed, because this

2 is what people will look at. So I just urge

3 you to do that. I think others have the same

4 view. Ed?

5 MR. AVOL: Yes. Just to follow up

6 on that point, I think this chapter, which we

7 all asked for and which you provided, I think,

8 is terrific in concept. It is what everybody

9 is going to look at.

10 I think that, if you believe that

11 you have made your points in the previous five

12 chapters, you just need to clearly summarize

13 that here. It was frustrating, frankly, to

14 read in some of these sections, because there

15 were so many qualifiers and side issues and so

16 forth that you sort of lost the point.

17 So I think, if you believe you

18 have made the point before, make it here and

19 underscore it, and if you are going to use

20 bullets, which is fine, a bullet ought to be

21 a sign to what the issue succinctly is, and

22 then the follow-on text afterward can say it.

Page 257

1 For some reason -- I am not quite

2 sure exactly why, although we have heard some

3 discussion -- you still seem to be sort of

4 defensive about these 15 cities. So

5 periodically, throughout this discussion, it

6 sort of comes up, well, there's other cities,

7 but we are using these 15, but don't believe

8 that other cities beyond the 15 don't have

9 health effects, as well.

10 Well, I mean, that is all sort of

11 taken care of up front. I think, if you are

12 going to bring that -- and it is appropriate

13 to bring that into the last chapter -- that

14 should be sort of right up front in the first

15 couple of pages, and then you are done with

16 it, because everything else follows from, this

17 is all based on this 15-city analysis.

18 I think you would be clear about -

19 - you know, if you believe what you have done,

20 just be clear about it, and go forward. Don't

21 be so --

22 DR. PEKAR: Karen and I were
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1 talking about this, and I won't say who is

2 responsible for writing it, but I think the

3 one thing to make -- I think we ended up doing

4 additional diagnostic work in that chapter

5 that should be pushed -- possibly pushed to

6 earlier chapters so that it can be more

7 summary, because there are points and

8 observations made in that chapter that were

9 not made earlier on.

10 So a lot of explanation, which

11 could be clearer -- but a lot of the

12 explanation, I think, comes from the fact that

13 we are starting to pull some of these

14 observations out here. I think those could

15 have been presented with a little more detail 

16 in earlier chapters, and then this could

17 really be summary. 

18 So that may help a little bit, but

19 I think there was fresh, interpretive work

20 done here which probably should have been in

21 earlier chapters.

22 DR. LIPPMANN: On this issue of

Page 259

1 the 15 cities, I think you don't need to be so

2 defensive about it. You had little choice in

3 the sense that a city could only be handled if

4 there were suitable sets of data for it.

5 If you take three out and put

6 another three in, it is not going to change

7 very much because it is an aggregate that you

8 are coming up with. So just say these are

9 reasonably representative of urban populations

10 in the U.S. They are not perfect, but

11 constrained by available data, these are the

12 cities you used, and you can make a statement.

13 I think it is extremely unlikely

14 that adding three or five more would

15 materially change the analysis. But then you

16 get back to this issue of you have evidence

17 that they are not -- that the coefficients in

18 these cities are quite different from each

19 other, which is attributable, at least in

20 part, to the compositional differences, which

21 you can't deal with in this round, but needs

22 to be keyed up for future research.

Page 260

1 I mean, everything is changing,

2 and risks are changing. What is the

3 consequence of the ever-increasing obesity in

4 the U.S. population? There is emerging

5 evidence that this adds risks to particle

6 exposure for obese people. So the population

7 is changing. 

8 So there is all kinds of things

9 that you can't control or analyze at this

10 stage, but you are doing a credible,

11 defensible analysis, and don't be so defensive

12 about it. 

13 You are making the best that can

14 be done with current knowledge and integrating

15 it perhaps more elegantly in the final

16 chapter, moving some detail back in chapters

17 earlier so it can be summarized in a bullet in

18 the last chapter, but I think you deserve a

19 lot of credit for a really good-faith and

20 competent, more than competent, effort at

21 getting us to this point.

22 Now that leaves a lot of

Page 261

1 unresolved issues, but you are obligated to do

2 the best you can with what you have.

3 DR. BRAIN: The other thing that I

4 really liked was -- from the 15 cities was you

5 clearly showed us how some cities benefit from

6 knocking the peaks, but the annual average

7 didn't make much of a difference, and the

8 reverse. I thought that was the sort of clear

9 lesson, conclusion, and hopefully that will

10 end up in Chapter 6, too, but I think that was

11 a really very positive illustration of that

12 principle.

13 CHAIRMAN SAMET: Well, I was

14 hoping we were feeling better about things,

15 but Sverre has a comment.

16 DR. VEDAL: One of the main

17 punchlines of this chapter that comes out in

18 your key points as well, and it is an

19 important one, is the emphasis on the annual

20 average, and as I take it, the argument is

21 that there is better consistency of health

22 protection when you use an annual standard as
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1 your controlling metric.

2 Health protection is a function of

3 long-term concentrations because that is where

4 the health impact is, not on the changes, not

5 on the acute effect changes. 

6 So I personally don't think that

7 is enough. I think it may be enough. It is

8 a pretty strong argument to base it on health

9 protection, but I just wonder whether there

10 are some other pillars you can build that

11 argument on than that observation. It is

12 really an important punchline, and it is going

13 to play a big role when we are in the policy

14 game. 

15 So I don't know. I mean, I don't

16 know -- it is not enough for me and you will

17 hear that, but I just would encourage you

18 maybe to -- you may have to just shore up that

19 case more strongly than you have.

20 CHAIRMAN SAMET: Okay. Any last

21 things on Chapter 6? I think we have covered

22 some very important issues for the whole

Page 263

1 document in discussing this and I think in

2 general I think we found it a very important,

3 useful framework and starting point and, I

4 think, discussed some of the issues. So

5 anything else that you want to go over? No.

6 Okay. So anything last before we

7 move off the risk assessment, anything else,

8 anybody, because we are going to move on to

9 visibility? All right.

10 DR. SPEIZER: Can I just ask, we

11 won't see this document again officially. 

12 Will it be part of -- will there be some

13 components of it that we can discuss at the

14 discussion of the PA, whatever changes?

15 CHAIRMAN SAMET: Actually, Karen,

16 I can't quite remember the timetable for

17 finalizing the -- it was probably in your

18 slides. It was in your handout, the schedule. 

19 Here it is. 

20 The final is April 2010. Is that

21 before or after our phone call?

22 DR. MARTIN: For finalizing?

Page 264

1 CHAIRMAN SAMET: The RA.

2 DR. MARTIN: For finalizing both

3 of the risk documents is the end of April.

4 CHAIRMAN SAMET: End of April. 

5 So I guess, Frank, the only thing I can tell

6 you is that, even though it is final, we can

7 still comment. So I think that is -- we

8 should just reserve that possibility when we

9 see it. 

10 Okay. Then we are going to move

11 on to visibility, which means that you have to

12 pretend it is Thursday morning, and turn the

13 schedule over. 

14 DR. MARTIN: I was unable to

15 reschedule the conference call.

16 CHAIRMAN SAMET: Okay. So public

17 commenter, Holly could not -- there are two. 

18 Okay. We will hear from them tomorrow.

19 So I think at this point then we

20 will have the overview, the revision.

21 DR. STALLWORTH: Tomorrow we have

22 public comments on the visibility assessment

Page 265

1 from Dave Heinold of the American Petroleum

2 Institute, and Anne Smith on behalf of UARG,

3 the Utility Air Regulatory Group.

4 DR. MARTIN: Okay. To begin here,

5 the agenda had lined out that we would start

6 by doing a very brief overview of the two

7 chapters in the policy assessment that relate

8 to welfare effects, visibility and other

9 effects on the secondary standard side and

10 then do a brief presentation on the visibility

11 assessment as a prelude to your discussion of

12 that document.

13 So if we are okay with that -- the

14 people here at the table with me: Vicki

15 Sandiford is the lead author on the visibility

16 chapter in the policy assessment and Meredith

17 Lassiter, the lead author on Chapter 5 on

18 other welfare effects. We also have Marc

19 Pitchford who is going to join us and make a

20 presentation on the visibility assessment

21 itself.

22 So if we can just quickly give a
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1 sense of the scope of these chapters in the

2 policy assessment.

3 MS. SANDIFORD: Sure, and there is

4 a handout. They just went around with the

5 slides that I am speaking from -- and Meredith

6 will be speaking from.

7 So Chapter 4 was focused on

8 looking at the adequacy of the secondary

9 standards for visibility-related effects and

10 we looked at the current suite of PM2.5

11 standards, and we had overarching questions

12 that we were seeking to address.

13 The first one of those was, does

14 the currently available scientific evidence

15 and visibility impact information as reflected

16 in the ISA and UFVA, Urban-Focused Visibility

17 Assessment, support or call into question the

18 adequacy of the visibility protection afforded

19 by the current suite of fine particle

20 standards?

21 In trying to address that

22 question, we looked at the newly available

Page 267

1 evidence as it was discussed in the ISA. That

2 included new air quality information from the

3 regional planning organizations and other data

4 collected through our own PM networks and then

5 looked at the temporal nature of the

6 visibility effect, the aspects of that

7 including what periods of time during the day

8 were people most impacted by visibility,

9 looking at the length of the exposure periods

10 and other atmospheric conditions that impacted

11 that effect.

12 We also looked at the levels that

13 should be considered in terms of what was

14 important from visibility impairment. We had

15 done a lot of evaluation, as you know, in the

16 UFVA on the preference studies and took that

17 into account.

18 We looked at were current air

19 quality conditions, and then did rollback to

20 just meet the PM2.5 standards.

21 We then went on to consider to

22 what extent information provided in those

Page 268

1 previous two documents and in the section of

2 the chapter looking at adequacy of the current

3 standards: was there support for considering

4 different pollutant indicators, averaging

5 times, forms and levels, to replace or

6 supplement the PM2.5 mass-based standards?

7 We looked at what we knew about

8 indicators, what might be appropriate

9 alternative indicators, considered the role of

10 coarse particles. 

11 We moved on to averaging time and

12 looked at the nature of the effect and the

13 nature of the exposure; what were the time

14 periods of most interest. Then we looked at

15 a range of levels for both alternatives that

16 we considered. We looked at different

17 percentile forms.

18 As you know, we followed your

19 advice and looked at the relative humidity

20 screen and a range of levels for different

21 forms -- indicators associated with the

22 standards that we were looking at.

Page 269

1 So that is the information that is

2 included in the current draft policy

3 assessment and hopefully, you have had a

4 chance to glance at that and it will provide

5 some context for the UFVA review. 

6 MS. LASSITER: In Chapter 5 we are

7 considering the non-visibility welfare effects

8 and the overarching question for that chapter

9 was: does the currently available scientific

10 evidence as reflected in the ISA support or

11 call into question the adequacy of protection

12 afforded by the current suite of secondary

13 standards?

14 So in this chapter, each of the

15 non-visibility welfare effects is considered

16 separately. We first considered climate, and

17 asked ourselves what new techniques are

18 available to assess aerosol-related effects on

19 climate. What is the nature and the magnitude

20 of these climate responses to PM? 

21 In that particular consideration,

22 we looked at both direct and indirect effects
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1 of aerosols, and then looked at global and

2 regional climate impacts.

3 Finally, in consideration of

4 climate, we looked at the evidence of specific

5 PM-related constituents such as black carbon,

6 organic carbon and sulfates and their effects

7 on climate.

8 Considering the ecological effects

9 of PM, I do want to point out here that the

10 NOx SOx secondary assessment considers some of

11 the depositional effects and then the

12 remaining effects of PM are considered in

13 Chapter 5 of the PM policy assessment and

14 there is a section at the beginning of the

15 chapter on the scope of the document.

16 So we looked at key scientific

17 evidence as available to improve our

18 understanding of PM effects on the soils and

19 nutrient cycling of wildlife, on water and on

20 plants, and also considered in this section

21 ecosystem sources associated with PM and

22 considered new techniques that were available

Page 271

1 for assessing PM-related effects on

2 ecosystems.

3 Finally, we considered what are

4 linkages that show ambient levels of PM to

5 effects on ecosystem components.

6 The final effect on welfare

7 considered materials effects. So in this

8 section, we review any new and existing

9 evidence for PM-related effects on materials

10 damage and soil link.

11 DR. MARTIN: Okay. If there are

12 no questions about the scope of the issues

13 covered in these last two chapters in the

14 policy assessment, we can move on and do our

15 presentation on the visibility assessment.

16 DR. PITCHFORD: I am going to give

17 you something to look at while I talk. You

18 don't have to look at me.

19 Okay. We have got a very short

20 presentation here, talking about the Urban21 Focused Visibility Assessment. Basically,

22 let's just go right to the second slide there.

Page 272

1 Let's talk about what we did

2 different in this second review draft compared

3 to the first review draft. Almost in every

4 case, I think, this was the result of

5 suggestions and comments from CASAC.

6 We conducted a logit regression

7 analysis on the response curve for the four

8 urban area preference studies. this allowed

9 us to see more than the dots on the curves and

10 I think it worked out very well.

11 We also did and sent out to you in

12 a supplemental document logit analysis

13 comparing the various components of the

14 Washington, D.C. focus studies. There was two

15 separate studies and in the second study there

16 were a number of substudies or separate groups

17 looking at different sets or subsets of the

18 slides.

19 We also replaced the 95 percent

20 relative humidity cap, which was similar to

21 what had been done for the regional haze rule,

22 with a 90 percent relative humidity screen. 

Page 273

1 In other words, we did not consider hours of

2 the day, daylight hours with relative humidity

3 above 90 percent in any of the assessments,

4 and we included an assessment of the effect

5 that having that screen had in terms of hours

6 of the day for the different cities that had

7 fog or precipitation or other impacts on

8 visibility.

9 By the way, we have got a

10 supplemental analysis that expands. As you

11 may recall, we only had Met data at the time

12 for 11 of the 15 cities. We have expanded to

13 all the 15 cities, and we had another

14 refinement. When we did the original, we were

15 looking at all hours of the day and some of us

16 didn't know that. So we refined it, and now

17 we've got just the daylight hours. In fact,

18 it doesn't change any of our overall

19 conclusions, but all the numbers change a

20 little bit.

21 We added the 98th percentile to

22 the 90th and 95th percentile forms that we had
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1 looked at before and we also added to the --

2 what we looked at before was the maximum

3 daylight -- or daily daylight hour for the

4 scenarios. We have added to that all hours

5 during daylight. So that is in there.

6 Then finally, we -- in order to

7 better display or to be able to show people

8 what the hourly daylight values for light

9 extinction look like, we incorporated some

10 what are called tile plots, which are very

11 colorful ways to show you what category of

12 visibility we are in for each of the 15 cities

13 for the three years and so forth.

14 Let's go on. In terms of what we

15 are asking in terms of feedback from CASAC,

16 basically sort of a generic question here: 

17 how well did we do or did we do well in

18 organizing and making new information that is

19 in the report.

20 Then the next three bullets are

21 basically asking about this new information

22 that I have just discussed: the logit

Page 275

1 analysis, adding values just for relative

2 humidity at or below 90 percent and also how

3 that effects the incidence of fog or

4 precipitation.

5 Then finally, the addition to the

6 national areas that considered all daylight

7 hours in the 98th percentile, giving you a

8 total of, I believe, 18 different scenarios to

9 look at.

10 So that is the essence of it, and

11 that is the last slide I have to show.

12 CHAIRMAN SAMET: Okay. Thank you,

13 Marc. Are there general questions before we

14 move to the charge questions? No? Okay.

15 So let's go to the first charge

16 question. I guess, Lowell, you are the lead

17 on that one.

18 DR. ASHBAUGH: Charge question 1

19 basically asks if the Panel agreed that the

20 level of detail provided is adequate and good.

21 Yes, I think the report contains a

22 lot of detail that is presented quite well. 

Page 276

1 Really, I think it is written very well. I

2 wouldn't recommend deleting any of it. The

3 organization is good, and I had a few comments

4 on some of the presentations later on.

5 My comments on charge question 1

6 are very short. It looks excellent. I don't

7 really have any negative comments on it. So

8 I am going to go on to the next.

9 CHAIRMAN SAMET: Okay. So I guess

10 other commenters? Phil?

11 DR. HOPKE: Again, I think my

12 comment was that it is long and somewhat dry,

13 but completeness of detail and useful given

14 that we are looking at a very different

15 indicator for a secondary standard. So if we

16 are going to provide the basis for making

17 significant change, then the i's have to be

18 dotted and the t's crossed, and I think this

19 does it.

20 CHAIRMAN SAMET: Okay, Dave?

21 DR. GRANTZ: And I agree with Phil

22 and Lowell. It is an excellent job and it

Page 277

1 was informative to read. I really liked it.

2 Having said that, in my comments I

3 say with very few exceptions. So I will

4 emphasize the exceptions.

5 I think Chapter 2 contains a

6 little bit more information in the body in

7 terms of the preference studies in the

8 individual cities. I don't think that much

9 detail needs to be in the body of the report. 

10 A lot of that can be moved to the appendix

11 without losing much of anything, I think.

12 Similarly I thought, if you were

13 going to create an appendix for that

14 information, the separate document for the

15 statistical analysis could be rolled in with

16 that, I think. There is no reason to keep

17 that separate where no one will see it. 

18 Then there were a couple of

19 discontinuities, I thought. I thought Section

20 4.1.3, which introduces considerations for

21 monitoring sites, was -- maybe I missed the

22 flow, but it just seemed completely out of
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1 place to me. Maybe it makes more sense if I

2 read it a different way, but I couldn't make

3 sense out of that logic.

4 Then Section 4.1.4 has a lot of

5 detail on modeling methods and the background

6 of the modeling approach. I think that also

7 could be moved to an appendix for enhanced

8 readability.

9 Other than that, I thought it was

10 really a very nice job.

11 CHAIRMAN SAMET: Okay. Other

12 comments on this charge question, this

13 document in general? Yes, Rich?

14 MR. POIROT: I agree with what

15 everyone else has said so far, and I think a

16 lot of the detail has to do with the inherent

17 complexity of the calculations, and also with

18 the number of options that are being

19 considered, many of which are our fault. We

20 kept asking for more and you gave it to us and

21 we shouldn't complain that there is too much

22 detail.

Page 279

1 I also thought that it was -- you

2 know, I was very interested in seeing how you

3 did the analysis and so, for the interested

4 reader, it was an excellent exposition of

5 exactly how you did it. I felt like I

6 understood what you did very clearly.

7 Then for the disinterested reader,

8 there were some nice, very concise summary

9 tables at the end that, if you just want to

10 see, here is the whole thing on one page. So

11 I thought it was a nice blend of those two

12 aspects.

13 CHAIRMAN SAMET: Yes, Joe?

14 DR. HELBLE: I just wanted to echo

15 Rich's comments, but focusing specifically on

16 Section 2. So perhaps I am disagreeing with

17 Dave, and it may be because we drove this

18 through questions we asked at the last CASAC

19 review, but I found Section 2 to be well

20 written and clear and I found it particularly

21 useful and I thought it was nicely summarized

22 at the end of that chapter.

Page 280

1 So I guess my take on it was, if

2 somebody wanted to skim it quickly and cut to

3 the chase, there was a very nice summary at

4 the end but I thought that detail was useful

5 to have in the body of the report.

6 DR. GRANTZ: Well, just to defend

7 my comment, I think a lot of detail is useful

8 and a lot of it is already in the appendices. 

9 I just thought, consistent with other

10 appendices, a lot of that material could have

11 been moved, because a lot of people are going

12 to read this document. 

13 A lot of people are going to read

14 through it and try to get the gist and I

15 thought there was just a little bit too much

16 noodling in the details that didn't really

17 contribute to the thrust of the document.

18 CHAIRMAN SAMET: Well, can't make

19 all the readers happy all the time. 

20 Other comments? So, Chris, I

21 think we are on to you.

22 DR. FREY: Yes, thank you. So

Page 281

1 charge question 2 is regarding the logit

2 analysis that is in Chapter 2.

3 One question is, does this

4 analysis add value to the urban visibility

5 preference study analysis. I think the answer

6 is yes.

7 Does it provide adequate -- or

8 provide additional support for combining and

9 comparing results from the four cities as

10 shown in Figure 216? I think the answer is

11 yes.

12 What are the Panel's views on the

13 clarity and adequacy of the descriptions, dot

14 dot dot. I thought that that section was very

15 clear and well written and made a lot of sense

16 to me and it seemed that it was adequate, too,

17 that it addressed all the issues that I would

18 think of that need to be addressed there.

19 The last question is: provide

20 comments on any additional insights that might

21 be drawn. I don't have any specific

22 suggestions in that regard. 
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1 I think overall it was a well

2 motivated section. I think it was an

3 appropriate discussion of the limitations of

4 the data. It was a clearly presented model. 

5 The model fit to the data was shown visually

6 in Figure 216. The parameter estimates are

7 given in Table 23 along with the T ratios. 

8 So I think there was a good basis

9 for critiquing the model fit to the data, and

10 also for the qualitative discussion of the

11 issues with the underlying data. 

12 I thought it was nice that there

13 was discussion of what the sort of physical

14 meaning of the coefficients were when

15 comparing the different cities.

16 I think the supporting memo that

17 is referenced in the charge question provides

18 some detail on a model that, I guess -- I

19 guess it is referred to, maybe, as more

20 integrated or less integrated. There is a

21 model 1 and a model 2 in that memo, and the

22 model that is in the report is model 2.

Page 283

1 I think model 1 and model 2 didn't

2 give dramatically different results, so they

3 were slightly different formulations. So I

4 think model 2 seems like the appropriate one

5 to bring forward to the main report and the

6 fact that you got similar results with

7 slightly different parameterization is some

8 indication of the robustness.

9 So I think overall it was very

10 good. I don't really have anything else to

11 say about it.

12 CHAIRMAN SAMET: Thank you. We

13 are going to give Tom a chance to comment

14 tomorrow. Lowell?

15 DR. ASHBAUGH: I agree, too, that

16 I like the logit analysis. I thought it is

17 important to the assessment, provides a common

18 basis to analyze the results.

19 One question I had was, and it

20 kind of just keeps coming up because of the

21 sparsity of studies, on page 231 you suggest

22 that additional studies would be useful to

Page 284

1 gain further understanding. Do you have plans

2 for such studies? Do you have an outline of

3 them? Is there perhaps a list of studies that

4 could be used for discussion or if funding

5 becomes available?

6 That was just something I was

7 thinking about as I was reading it. It would

8 be useful to have plans ready in case we can

9 do something like that.

10 CHAIRMAN SAMET: Okay. Phil?

11 DR. HOPKE: One of the things that

12 struck me is that light extinction goes as C

13 times L, concentration times distance. The

14 fact that we see apparently a shift in the 50

15 percent point from the places where there is

16 the greatest distance to the shortest distance

17 struck me as a way of -- something that ought

18 to be looked at, and whether in fact, the mid19 points on those derived logit curves could be

20 correlated with the inverse distance to the

21 furthest visible feature in these figures and

22 whether that might then give us a better

Page 285

1 understanding of why we are seeing the kind of

2 variability, basically, between 20.3 and 29.4

3 or something like that, simply because in

4 Washington, D.C., there's no hills in the

5 background. 

6 I mean, Capitol Hill is not a big

7 deal, except to those who live there. But

8 there is no significant distance object which

9 would become obscured at a lower level because

10 of the distance.

11 So I think that would be very

12 informative if we could start to look at how

13 that most distant object effected the

14 perception as reflected in those different 50

15 percent points.

16 CHAIRMAN SAMET: Okay.

17 DR. ASHBAUGH: I commented in my

18 written material, too, that there might be

19 other factors as well that effect these

20 results and why they shift from place to place

21 just due to who is living in those places or

22 how attuned they are to what is out there and
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1 just having the ability to see something far

2 away. That may explain it as well. I think

3 there might be other things as well that could

4 explain it.

5 CHAIRMAN SAMET: So there is

6 really an agenda here for designed experiments

7 with building all these factors in in sort of

8 the factorial approach to try and sort this

9 out, I think. Dave?

10 DR. GRANTZ: Well, I think you

11 have just summarized what I was going to say. 

12 We clearly need further studies on this. 

13 My concern with the way it stands

14 is that I think the data that are available to

15 us indicate there are true regional

16 differences. So to draw a mid-point or some

17 central tendency through things that really

18 represent different groups, I am not sure is

19 going to be defensible. That worries me.

20 CHAIRMAN SAMET: To be discussed

21 in the policy analysis.

22 DR. GRANTZ: Yes. Well, I mean,

Page 287

1 the caveats keep growing with each document

2 and I have read the policy analysis and it is

3 appropriately flagged as uncertain. 

4 Nevertheless, we are plowing ahead. 

5 CHAIRMAN SAMET: Phil pointed out

6 that there are people differences, and then

7 Phil's comment about the vistas and the

8 geographic differences which are there. After

9 looking at Albuquerque for years where you

10 would go, well, gee, can I see Mount Taylor,

11 which happened to be 70 miles away, or not --

12 you know, as your benchmark.

13 DR. GRANTZ: Well, it may be the

14 people that choose to live there, and it may

15 be the comment that I made, that it is what

16 you become accustomed to wherever you live.

17 They showed in one of those

18 studies that the range of slides that you

19 present skews the answer. So I think we just

20 don't know very much about that, and it is way

21 premature to judge why that is going on, but

22 I think to find a central tendency and stick

Page 288

1 to it is a little bit dangerous.

2 I wrote that before I read the

3 policy assessment, but now that it is clear

4 that we are really heading directly into a

5 visibility-type standard, that becomes really

6 important, far more important than if it was

7 a mass standard reflected in visibility.

8 CHAIRMAN SAMET: Okay. Other

9 comments on charge question 2? Then, Rich,

10 you can handle 3?

11 MR. POIROT: Well, I would just

12 like to maybe raise the counterpoint to

13 David's point, and that is, I thought -- well,

14 first of all, the logit analysis, to me, was

15 quite helpful and really nicely done. I

16 thought it helped in also supporting some of

17 the consideration of alternative hypotheses

18 for why there were differences in responses

19 across the areas.

20 I certainly felt that with that

21 addition you have squeezed pretty much all of

22 the information you are going to squeeze out

Page 289

1 of those studies. It is a little bit of a

2 game, you know, when you say to contrast, on

3 one hand, this is sufficient information, but

4 on the other hand, we need more of this kind

5 of work. It is a balancing act.

6 To me, I came down more on the

7 side of looking at the relative convergence

8 across the different studies, especially when

9 we get into slightly different, other than the

10 50th percentile response of unacceptable and

11 so forth. To me, I saw more lines that

12 converged rather than lines that diverged. 

13 So I think you could see it that

14 way as well. To me, it provided what I

15 thought would be a sufficient basis to go

16 forward with selecting a specific level from

17 within that range as justifiable without

18 diminishing the need for more studies like

19 this.

20 CHAIRMAN SAMET: Okay. Should we

21 go on to Charge Question 3?

22 MR. POIROT: Do I have 3?
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1 CHAIRMAN SAMET: Well, it was you

2 or Tom, so I was hoping that you could.

3 MR. POIROT: Tom will, hopefully,

4 be able -- possibly later this afternoon or

5 possibly tomorrow morning, maybe. 

6 CHAIRMAN SAMET: Do you want to

7 leave this one for now? That is fine.

8 MR. POIROT: Not necessarily. I

9 can say what I have to say about it.

10 CHAIRMAN SAMET: Okay, go ahead.

11 MR. POIROT: You know, I

12 personally thought that the 90 percent RH

13 screen was a good idea. I recommended it last

14 time, as did others. This gets back to a

15 point I made earlier.

16 I think it is a good idea for use

17 in this assessment, but I also think it is a

18 good idea for use in terms of a metric for a

19 standard, which are two completely different

20 things.

21 I thought that the analysis

22 presented in terms of what effect this 90

Page 291

1 percent RH screen would have on eliminating

2 incidences of naturally occurring weather:

3 fog, rain, snow, sleet, et cetera, was very

4 well done, especially as it has been repaired

5 or redone in the memo that we only just became

6 aware of.

7 I note that Lowell has some

8 specific comments on that that point out some

9 miswording that is very important that I will

10 let him get to in a minute.

11 I believe that there are other

12 good reasons, aside from just the elimination

13 of weather to employ that kind of an RH

14 screen, especially as we look toward a

15 standard. I think that it would -- we want to

16 avoid any possible public perception that EPA

17 is regulating the weather, and I think it

18 really would help to do that quite a bit by

19 not considering those higher levels of

20 humidity.

21 I think also, in terms of making

22 the measurements there, if you let these very

Page 292

1 large fog droplets into your nephelometers,

2 you gum them up, and you have to take them

3 down and clean them and so forth. 

4 So in terms of how you make the

5 measurements, there are benefits to perhaps

6 adding a smart heater or something that would

7 eliminate the high RH levels as you are making

8 the measurements. You can make essentially

9 better quality measurements of everything

10 else.

11 There are also issues, of course,

12 of the variability of the humidity and the

13 weather along different aspects of the sight

14 path. It is one thing to say, well, RH above

15 90 percent and it is also foggy at this

16 monitor, but what about RH above 90 percent? 

17 Is it foggy anywhere within your sight path of

18 your urban area?

19 I am not suggesting that needs to

20 be done, but that would be a way to ask and

21 answer that question, would be to look at the

22 variability, co-variability of RH and weather

Page 293

1 conditions across a wider region. 

2 I don't think you need to do it. 

3 I think what you have done is very adequate. 

4 It makes an eloquent demonstration that this

5 RH screen eliminates a small percentage of the

6 hours from consideration and gets rid of

7 almost all of the weather effects, and I think

8 that was the main point. You have done that

9 very well.

10 So that is, I think, about all

11 that I had to say about it.

12 CHAIRMAN SAMET: Okay. Others? 

13 Lowell?

14 DR. ASHBAUGH: I guess I will just

15 add my comments, too, now. I am actually

16 surprised that I didn't notice that the number

17 of hours in the column labeled number of

18 daylight hours actually added up to nearly the

19 number of hours in the three-year period which

20 is what was corrected in this memo we got

21 about 15 minutes ago.

22 So I think I had made the comment
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1 that one of the statements in the report just

2 wasn't correct, because there were other sites

3 that were greater than six percent of the

4 hours, but that was based on all hours. 

5 I think, after reviewing the

6 latest report, I think the numbers are closer,

7 and certainly on average it is less than six

8 percent, but a few sites do have more. But I

9 think you have done an excellent analysis, and

10 it is appropriate to do it. So regardless of

11 the error, which I think has been corrected

12 now, I think it is a good analysis, and should

13 be done.

14 CHAIRMAN SAMET: Anything else on

15 -- this is charge question 3 still.

16 MR. POIROT: Could I add one

17 thing? I ended up sending my draft comments

18 around to some of the folks, including Bill

19 Mullen who wrote back a quick e-mail saying

20 that he agreed that the use of the 90 percent

21 screen was appropriate. 

22 He also indicated you might -- in

Page 295

1 his experience, you might go up in terms of

2 making the measurements as high as 95 percent

3 with something like an nephelometer, but

4 warning that determining the RH is not always

5 that easy. So when you are measuring 95

6 percent, unless you are really carefully

7 watching your calibration, it could be at much

8 higher levels. 

9 So he, who I think, was generally

10 supportive also of the 90 percent RH

11 screening, and also kind of like mentioning

12 the idea of using a Smart Heater to eliminate

13 those hours.

14 Again, none of this reflects

15 actually on the risk assessment document. It

16 is more onto the next stage.

17 CHAIRMAN SAMET: So do you want to

18 go on to 4? I think that's you. 

19 MR. POIROT: I guess we don't have

20 the charge questions written up there. Should

21 I read the charge question?

22 In response to CASAC

Page 296

1 recommendations, description of current

2 conditions and results of just meeting NAAQS

3 scenarios that considered all daylight hours

4 were added to those based on maximum daily

5 one-hour indicators. The 98th percentile form

6 was also included along with the 90th and 95th

7 percentiles. Tile plots of hourly PM light

8 extinction, Figure 3-12, and composition bar

9 graphs for the top 10 percent of the days for

10 maximum daily one-hour and aggregated

11 individual daylight hours, Figure 3-13, were

12 shown in part to help illuminate the

13 similarities and differences between these

14 various indicators with respect to current

15 conditions.

16 Similarly, additional figures and

17 table entries were generated to illustrate the

18 characteristics of various PM light extinction

19 NAAQS scenario forms, Tables 4-2, 4-5 and 4-7,

20 Figures 4-1 through 4-3. 

21 Now comes the question: What are

22 the Panel's views regarding EPA's staff

Page 297

1 interpretations of these displays included in

2 the text or the supplemental or alternative

3 interpretations? Are there supplemental or

4 alternative interpretations the Panel would

5 suggest? Are there additional approaches the

6 Panel would suggest regarding ways to

7 summarize, display or assess the results of

8 these analyses, including similarities and

9 differences between the various scenarios?

10 That's the question. 

11 CHAIRMAN SAMET: And the answer

12 is?

13 MR. POIROT: I guess I thought all

14 of the additions were useful, and very

15 responsive, I might add, to our requests from

16 last time around. We asked for it, and they

17 gave it to us.

18 I thought the tile plots -- I had 

19 actually never seen those kinds of graphics

20 before -- were not only very informative and

21 interesting, but I would like to have a couple

22 to frame and put in my living room. They are
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1 very lovely, some of them, and they really

2 illustrate some details, if you sit there --

3 for the interested the reader, sit there and

4 stare at some of them for a while.

5 For example, they really helped me

6 to see how in some of the eastern urban areas

7 the 90 percent RH screen really would kick out

8 a number of those early morning very humid

9 hours, which is something that I have been a

10 little bit worried about. So I thought they

11 were -- yes, they were very effective and

12 useful graphics, in my view.

13 The plots that show the maximum

14 hourly extinction on the top 10 percent of the

15 days, and also compare those with the top

16 percentile extinction using all of the

17 available daylight hours -- for the rest of

18 you, to kind of tee this issue up a little

19 bit, what was initially suggested was to

20 calculate a percentile based on first

21 calculating a single worst daylight hour of

22 the day, and then you would calculate what is

Page 299

1 the 90th or 95th or other percentile of that.

2 The alternative approach that we

3 had suggested was to consider using all the

4 available hours of the day and throughout the

5 year, and calculating your percentiles based

6 on all of the available daylight hours rather

7 than just the single worst hour of the day.

8 So they considered that, and so

9 the question is: Are our graphics in which we

10 compare the results of these two things, these

11 two approaches on high percentiles -- do they

12 clearly communicate the similarities and

13 differences?

14 I thought they were interesting to

15 look at, but I guess I wasn't quite convinced

16 that they really displayed apples and apples. 

17 On the one hand, when you are using only the

18 worst hour of the day, there is sufficiently

19 few of those that you can show all of them in

20 terms of bar graphs for each day. But when

21 you are looking at the 95th or the 90th

22 percentile of all of the daylight hours, there

Page 300

1 are way too many of those to show them in the

2 same way.

3 So I guess I think it would be

4 useful to really get a better sense of what is

5 the real difference between those two

6 approaches. You know, one of my concerns was

7 that the single worst daylight hour seemed to

8 be somewhat of an illogical thing to combine

9 with a very low percentile, like the 90th

10 percentile.

11 It seemed illogical, because it is

12 saying, on the one hand, one bad hour ruins my

13 entire day; and on the other hand, I am mad as

14 heck about it, but I am not going to get mad

15 until it happens on the 37th day of the year. 

16 It just seemed like it was taking kind of an

17 extreme thing on one end, and mixing it with

18 an opposite extreme on the other end. So it

19 just made me a little squishy there.

20 Watch out for me, because I am

21 going to try to dry this thing out a little

22 bit, and so I am coming a little bit from that

Page 301

1 perspective of I think there would be benefits

2 to having somewhat of a drier extinction

3 standard in terms of reducing east-west

4 differences, but I don't feel real strongly

5 about that. But it was one of the reasons why

6 I preferred using all the daylight hours

7 rather than a single worst hour, was that I

8 thought the single worst hour would be tending

9 to occur just after dawn, and I think it often

10 does, not always, but it often does, and it

11 would be a very high humidity condition and so

12 forth.

13 So I might add that Bill Mullen

14 also commented back on the same thing,

15 although he has the opposite view, I think. 

16 He kind of likes the single worst hour, but

17 had sort of the same comment that I did, is

18 what we would really like to do is be able to

19 see what is the difference between those two

20 approaches. What is the real difference in

21 the chemistry and, by inference, the kinds of

22 sources that you would be going after if you
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1 used the one metric versus the other. So that

2 is kind of the advice we have.

3 I actually think you could get to

4 that in the policy assessment. It doesn't

5 necessarily need to be illustrated here, but

6 just to know what the difference is would be

7 useful.

8 What else? So my last point about

9 that was the -- well, maybe it is obvious. I

10 don't know that we have many one-hour control

11 strategies that we could -- especially for

12 sulphate and nitrate -- that we are going to

13 be able to implement to fix that one hour

14 uniquely, on the one hand; and on the other

15 hand, just to me, a day where it is hazy all

16 day is more objectionable to one where it is

17 briefly hazy.

18 Those are policy kinds of

19 considerations. The point, though, is that it

20 would be useful to really see what is the

21 difference somewhat more clearly. 

22 That is all I have to say about

Page 303

1 it.

2 CHAIRMAN SAMET: Lowell?

3 DR. ASHBAUGH: Okay. I really

4 like the tile plots as well. I don't know if

5 I would want them on my wall, but they are an

6 excellent way to show the data and show what

7 we are looking at. I like that a lot. 

8 One thing I would like to see

9 different in them is to have them scaled such

10 that you can compare one year to the next,

11 just straight across without having to jump

12 around, and especially for, like, Houston and

13 Phoenix where there is nine months. Scale it

14 so that they apply to just the nine months of

15 the year, so it is easier to see on the page.

16 I also like the staff

17 interpretation of the plots, but I do think

18 that in Section 3.4.4 you can have more of a

19 discussion like you have in 3.4.5. I have

20 some examples in my written material. I won't

21 read them all, but it is just a little bit

22 more of a description of each city and what is

Page 304

1 going on in it. I think it would be useful to

2 have it there.

3 I do like the extinction budgets

4 shown in the top 10 percent of days and the

5 top individual 10 percent daylight hours, and

6 the interpretation of those plots is good

7 also.

8 I am very concerned about the high

9 contribution of light extinction at L.A., for

10 example, from the coarse PM on those two days. 

11 I have done an awful lot of data validation

12 for improved data. Even though I know there

13 can be high hours and extremely high hours of

14 PM-10 mass, I also know there can be errors in

15 the data.

16 I just question data that looks

17 that way. So on the one hand, I like seeing

18 both those displays, but on the other, I tend

19 to question some of those extreme outliers,

20 and they, in fact, be wrong. It may just be

21 an error. 

22 So I would like to have some

Page 305

1 comment about that or at least acknowledge

2 that that is a possibility, because it happens

3 all the time, I think far more than people

4 realize when they are looking at monitoring

5 data.

6 Also, the explanation that coarse

7 PM is determined in part from measurements at

8 Victorville could well explain problematic

9 measurements or problematic values at Los

10 Angeles and Riverdale. Victorville is

11 completely separate from those others.

12 A couple of other details: Sea

13 salt is an important constituent at coastal

14 sites, and I have a little problem with the

15 sandwich approach relying on mass closure to

16 determine hourly organic carbon, because that

17 presumes that all the other species are

18 accurately determined. Especially if you are

19 not including sea salt at some locations, that

20 could be a real problem.

21 I know Warren White has done some

22 work on that showing the prevalence of sea
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1 salt, especially in coastal areas.

2 Also, setting negative values to

3 zero -- this is on page 3-26 -- what I'm

4 looking at, the coarse PM introduces a bias in

5 the results. There are times when there is

6 not much coarse material there. It is all

7 fine, and there is enough uncertainty in both

8 the PM2.5 and the PM-10 measurements that you

9 can have a difference that is negative, just

10 because of the uncertainty. 

11 By setting negative results to

12 zero, you introduce a bias into the results,

13 and that shouldn't be. That is -- it is real

14 important, I think, to retain negative values

15 as a measure of uncertainty during those low

16 mass periods.

17 I will just say it one more time. 

18 I have grave doubts about those outlier

19 concentrations at L.A. and St. Louis. I would

20 like to see those looked at long and hard.

21 I have a few editorial changes

22 that I put in the written material, but I

Page 307

1 won't go through those here now. And that is

2 it.

3 CHAIRMAN SAMET: This is charge

4 1uestion 4. Other comments? Yes? Phil?

5 DR. HOPKE: One thing that I would

6 like to suggest is considering looking at

7 visibility based on PM2.5 only. Right now,

8 all of the things have included coarse, and

9 there are some significant measurement issues

10 that arise if coarse gets mixed in, some of

11 which were discussed two weeks ago at the

12 Ambient Monitoring Subcommittee meeting.

13 The key question is whether -- you

14 know, again, given the heterogeneity of the

15 coarse and other sorts of things, it might

16 make more sense -- again, originally, the last

17 go-round, it had been proposed to use fine PM

18 mass as the indicator for urban visibility.

19 The vast majority of the urban

20 visibility degradation is fine particles, and

21 I think it would be helpful to understand a

22 little better as to how much of a difficulty

Page 308

1 would really there based on the data if we

2 were to only base it on a fine particle

3 visibility data standard rather than a PM-10

4 or a PSP visibility standard. It would

5 simplify things considerably to have a fine

6 particle visibility standard.

7 CHAIRMAN SAMET: Okay, other

8 comments on charge question 4? Ted, do you

9 have anything you want to add on this?

10 DR. RUSSELL: Actually, just if

11 you look at the schedule originally, there was

12 thought that I might talk a little bit about

13 what did occur, as Phil said, about two weeks

14 ago. 

15 We had the Ambient Air Monitoring

16 and Methods meeting that was in response to a

17 white paper that EPA put together that asked

18 us to lend our advice on the approaches that

19 they were going to do to use to measure light

20 extinction directly in response to having a

21 light extinction standard. 

22 So that meeting was about two

Page 309

1 weeks ago where we looked at some of the

2 methods, as Phil and Rich discussed, in terms

3 of instrument limitations or problems, looking

4 at coarse particles. 

5 The thought was that, again, it

6 might be best, it might be much more

7 technically feasible if we looked at smaller

8 particles essentially limiting it to the

9 PM2.5, and we probably would not be losing a

10 significant fraction of the visibility

11 extinction, also the issue associated with

12 relative humidity.

13 So that meeting -- we really

14 looked at the type of methods that were

15 available and basically came to the conclusion

16 that the methods are available. I mean, right

17 now they might be looking at a combined

18 nephelometer-ethylometer pair, one measuring

19 scattering, the other one absorption, but

20 there are some interesting methods that could

21 become available shortly that would do it all

22 at once.
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1 So it is technically feasible, if

2 you want. There is the report from that

3 meeting where we addressed the white paper

4 that they developed and their charge

5 questions. It is available, if you want to

6 see it. Holly could get you a copy. I think,

7 actually, it is posted, isn't it?

8 We basically came down to say that

9 it is technically feasible to do it. There

10 are -- the instruments are available. It 

11 would probably be better to look at just PM2.5

12 and to keep it at 90 percent or below relative

13 humidity.

14 That was it.

15 CHAIRMAN SAMET: Thanks. Can I

16 ask a general question for the visibility

17 mavens or whatever you are. 

18 DR. HOPKE: The key also is to

19 note that, just like economists, we need only

20 one-handed visibility people.

21 CHAIRMAN SAMET: The question,

22 though: With the risk assessment we asked for

Page 311

1 this Chapter 6, this integrative chapter, and

2 this one sort of just comes to a halt in its

3 specifics, and without sort of pulling things, 

4 in a way, together. 

5 Does this need an integrative

6 chapter as well? I don't know. For those of

7 you who looked at it, would that be helpful,

8 in part for communicating more generally about

9 the findings. There is a lot of detail, and

10 this is important. This is going to represent

11 a new step forward, if we end up with a

12 visibility standard.

13 So I guess I would question, when

14 you look at the structure of the document,

15 would it benefit from -- I guess it would be

16 a Chapter 4 -- or 5? Five. Sort of an

17 integrative summary kind of chapter.

18 DR. HOPKE: Or an executive

19 summary.

20 CHAIRMAN SAMET: Yes, or something

21 to bring it together.

22 DR. ASHBAUGH: I do think an

Page 312

1 executive summary, something to tie it all

2 together, would be useful.

3 CHAIRMAN SAMET: Yes, and whether

4 it comes at the beginning or the end, but just

5 -- It is good. There is a lot of detail. 

6 There is an awful lot to bring together.

7 DR. ASHBAUGH: And, actually, I

8 wouldn't mind seeing it at the beginning to

9 tie it together, and then everything else in

10 the back. That would be good as well.

11 CHAIRMAN SAMET: So some form of

12 summary somewhere, I think. Other comments on

13 this, visibility? Well, here we have public

14 comments tomorrow. So remember that, and then

15 we also will hear from Tom, I guess, if he

16 comes on later today or tomorrow morning. I

17 think Rich and Joe.

18 MR. POIROT: Just to follow up on

19 Lowell's point about the, in some cases,

20 apparently illogical high coarse

21 contributions. I, in my written comments,

22 include an example from St. Louis that I

Page 313

1 thought helped show that those seemed

2 illogical, plus talking to the locals on the

3 ground there, they say, oh, don't use that

4 data. 

5 On the other hand, what I would

6 like to -- well, let me set this up a little

7 bit. You know, I was a strong advocate in the

8 last review cycle for the use of the sub-daily

9 secondary fine particle standard as a

10 visibility protective standard. 

11 I thought it was a good idea then. 

12 I still think it is a viable idea. So I've

13 got that bias and that pre-stated position,

14 and a lot of energy went into it and so on and

15 so forth. However, I really like this new

16 proposed PM light extinction indicator. 

17 Frankly, I didn't know that the lawyers would

18 let us do this last time around. We didn't

19 know it was an option.

20 I would like to really emphasize

21 what I think is its strength. We have got the

22 opportunity here to have an indicator that is
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1 the effect, that is very close to being the

2 effect. Imagine, all you health guys, if you

3 could have some incidence of cardiac

4 mortality, and that would be the indicator of

5 whether or not we were attaining the standard.

6 Well, that is about how strong

7 this relationship is. So because of that, I

8 think it would be desirable to try to keep

9 this indicator actually as pure and direct as

10 we can. Light extinction and even PM light

11 extinction is an actual physical

12 characteristic of the atmosphere. It exists. 

13 It preexists, it's out there.

14 There are some issues about

15 whether and how we can best measure it

16 properly, but it is a real thing. So I would

17 like to kind of -- even though I have been

18 critical of some of the coarse particle

19 calculations and it is difficult and the

20 instruments don't respond well and all those

21 kinds of things, I would like to keep on the

22 table and keep advocating for the keeping of

Page 315

1 the indicator as being PM light extinction.

2 Even if we are not currently able,

3 for example, to measure every aspect of it

4 with great satisfaction, I think, rather than

5 compromise the indicator, I would like to

6 advocate in the other way. Let's keep this as

7 a good conceptual indicator, and count on

8 being able to quantify it better and refine it

9 better in the future. 

10 CHAIRMAN SAMET: Joe.

11 DR. BRAIN: It sounds like opening

12 another box of Pandora's, but I guess my

13 question was: You know, this is a little bit

14 like sophisticated, ever more sophisticated

15 measurements of blood pressure or BMI without

16 thinking about the consequences.

17 So do you want to include anywhere

18 in here, somewhere, you know, what are the

19 consequences of poor visibility? What effect

20 does it have on mood, traffic accidents,

21 housing values? We have seasonal affective

22 disorder. Is there PVAD, poor visibility

Page 316

1 affective disorder? Is it related to

2 exercise?

3 Seems to me it is sort of missing

4 -- even if it is highly speculative, what is

5 the human impact of poor visibility? Where is

6 that? Where do we deal with that?

7 CHAIRMAN SAMET: You know, we did

8 have some of that kind of discussion last

9 time, and I think that had to do with sort of

10 this as a -- the visibility as an indicator

11 and its human implications. I guess maybe

12 none of that is written.

13 DR. STALLWORTH: Bill Mullen made

14 the point that these questionnaires that ask

15 people to think about visibility only in non16 health terms are flawed, because he thinks

17 visibility does have health impacts, and it

18 should be incorporated in the questionnaire. 

19 That is what he said in his comments.

20 DR. BRAIN: Then maybe we need

21 someone on the Panel who is really a 

22 psychologist or -- people exercise less when

Page 317

1 the visibility is poor. That would have a

2 real health impact. I don't know. Seems to

3 me, there are lots of potential implications. 

4 We all know we feel -- you know, you said how

5 great it is when you look out your window and

6 you can measure the visibility. Are you much

7 easier to get along with and a better boss

8 when the air is clean? We will have to ask

9 your wife about this.

10 CHAIRMAN SAMET: It is not about

11 me. But I think it is almost implicit, but it

12 is not explicit. The definitions of health

13 all incorporate well-being or the WHO charter

14 definition 1948 does.

15 This question of what constitutes

16 an adverse health effect, if you go back to

17 the most recent -- I guess it is the 2000 ATS

18 statement -- these notions are there. Maybe

19 this at least needs to be some preamble

20 discussion of these issues.

21 DR. BRAIN: I think so. The

22 silence seems conspicuous, that it doesn't
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1 mention --

2 CHAIRMAN SAMET: Maybe it goes

3 back to -- I do remember this discussion at

4 our last meeting, and maybe Bill had some of

5 this in his comments. I just don't recall. 

6 MS. SANDIFORD: We are going to

7 address that a little bit more in the policy

8 assessment. There was discussion in the ISA,

9 and we are not sure how much of that

10 information is useful in informing a selection

11 of different aspects of standards, but we

12 definitely will be looking at that a little

13 bit more.

14 DR. BRAIN: I mean, in the absence

15 of that, how do you use the information, if it

16 has no impact on anything or anybody? So

17 what? It seems to me, without that, where are

18 you?

19 MS. SANDIFORD: Well, the public

20 welfare effect that we are looking at is not

21 only the aesthetics of visibility impairment

22 but the impact on a person's sense of wellPage 319

1 being. That is part of the definition. So it

2 is part of the scope of what we look at.

3 What we are not clear about is

4 what kind of information on exposure duration

5 is in those studies, and we will need to go

6 back and look at that some more.

7 CHAIRMAN SAMET: Are there other -

8 -

9 DR. GRANTZ: I have a question. 

10 Are there any other data besides those four

11 city preference studies that you can use for

12 that purpose?

13 MS. SANDIFORD: For the

14 psychological impacts? Yes. Oh, I think so. 

15 The ISA list -- Chris is over there in the

16 audience, but there are a number of different

17 studies that were identified where they made

18 this link between the visual air quality and

19 the effect on a person's sense of well-being,

20 but we have not investigated those to the

21 degree that we know what it says about the

22 duration of those exposures, whether they are

Page 320

1 explicit about that or not.

2 DR. GRANTZ: But in terms of

3 magnitude for whatever period, they are

4 explicit?

5 MS. SANDIFORD: Yes.

6 CHAIRMAN SAMET: Okay. It is 3:30

7 on Wednesday. We have done the risk

8 assessment. I think we have finished the

9 visibility. I think the question of what we

10 do next is something to discuss.

11 We still will hear from Tom when

12 we can hear from Tom about the visibility

13 document. We have two public commenters. I

14 am tempted -- and I think this is something we

15 can discuss. 

16 We are ready to maybe take a

17 break, and then possibly move on to discuss

18 the charge questions for the policy

19 assessment, to take a look at those, and then

20 we can revisit this tomorrow after people have

21 had a chance to sort of at least perhaps skim

22 through the policy assessment document.

Page 321

1 I think the other alternative for

2 the committee is to take a break and then come

3 back here and work. Notice I didn't say like,

4 you know, go for a walk or anything like that. 

5 So come back and work on comments.

6 I think going through the charge

7 questions might be useful and perhaps frame

8 what we want to look at, particularly, tonight

9 in the policy assessment, so we can come back

10 tomorrow with perhaps a sharper discussion

11 than it would be. So would that work for EPA? 

12 Do we have the right people around?

13 DR. MARTIN: Well, no.

14 CHAIRMAN SAMET: Well, Lydia is

15 not here in any case. Right?

16 DR. MARTIN: Pardon me?

17 CHAIRMAN SAMET: Lydia was not

18 coming. Right?

19 DR. MARTIN: Some of the other

20 staff -- well, okay. Beth is here. We can go

21 through sort of walking through those charge

22 questions now, and then come back in the
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1 morning and get further thinking on them.

2 CHAIRMAN SAMET: I think that is

3 what I was thinking. We can take a break, and

4 then reconvene. Is that okay with everybody

5 to do that? Okay, all right.

6 DR. SPEIZER: Jon, I think we will

7 work tonight to create the comments for the

8 Administrative letter.

9 CHAIRMAN SAMET: I think, ideally,

10 we would get some writing done tonight, too,

11 yes.

12 DR. PHALEN: A couple of questions

13 regarding travel. When do you see us

14 finishing up tomorrow?

15 CHAIRMAN SAMET: I actually really

16 don't know. Presumably, we are going to

17 finish earlier, but I think it is a little

18 hard to --

19 DR. PHALEN: Too early to start

20 finding earlier flights home?

21 CHAIRMAN SAMET: We could start at

22 7:00 a.m. and get done quite early, but we

Page 323

1 probably won't. I think let's come back to

2 that, Bob, and see. I think, in part, one

3 reason to look at the charge questions is to

4 try and sort of maybe frame our discussions

5 for tomorrow and how big they are going to be.

6 So let's take a 15-20 minute

7 break. Phil, good trip back.

8 (Whereupon, the above-entitled

9 matter went off the record at 3:31 p.m. and

10 resumed at 4:02 p.m.)

11 CHAIRMAN SAMET: I think what we

12 will do is spend some time going through these

13 so we can, if nothing else, preview what we

14 are going to be asked to do in looking at this

15 draft and again, I think, maybe sharpen our

16 comments.

17 Remember that we do have a --

18 right now it is two half-days scheduled for

19 discussion of the first draft. So there is a

20 fine dividing line between talking about the

21 charge questions and what we are going to be

22 doing and how we are going to approach it and

Page 324

1 talking about the first draft. So let's try

2 and stay on the charge question side of the

3 divide, wherever it may be.

4 Who is going to lead this -- the

5 presentations?

6 MS. HASSETT-SIPPLE: So in

7 thinking about these charge questions, we

8 initially thought that we had overarching

9 questions that applied to the four substantive

10 chapters. You have a chance to look at the

11 document. 

12 Chapter 1 is just introduction,

13 organization, a little bit of PM history, but

14 we really tried to focus on more details for

15 the history, and recent litigation, the

16 chapters where it was most applicable, so in

17 Chapters 2, 3 and 4.

18 Looking overall, we felt that

19 there was some general questions that applied

20 to all of the substantive chapters, 2 through

21 5, on organization and technical content. So

22 the first charge questions that you see relate

Page 325

1 to those four chapters.

2 So I don't know if you want to

3 take the time -- I don't know if you have had

4 a chance to read through them or if you want

5 to take a few minutes to look through them.

6 DR. LIPPMANN: Without knowing

7 what is in it, we can only ask some questions. 

8 I would be curious about how margin of safety

9 will be dealt with, because that's, I think,

10 clearly a policy relevant issue. And with PM,

11 one can argue that there is no margin of

12 safety as long as we assume linearity and some

13 response as adverse, if mortality is an

14 adverse response at any level.

15 So how can a document address

16 setting a margin of safety under that kind of

17 constraint?

18 MS. HASSETT-SIPPLE: Well,

19 remember that this document is to inform the

20 Administrator's decision. So ultimately, it

21 is the Administrator's judgment on how she

22 views setting standards with an adequate
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1 margin of safety. 

2 What we have tried to do in

3 Chapter 2 -- and I can't speak as much about

4 Chapter 4 and 5, and Chapter 3 is almost a

5 promise to come, because we really need to get

6 some feedback from CASAC and the public. But

7 in Chapter 2 on fine particles and the primary

8 standards, what we have put together with our

9 preliminary draft conclusions are to talk

10 about, if we put more weight on different

11 parts of the evidence, where it leads us

12 toward as far as level, and it's really --

13 this first draft is really all about level

14 with some initial discussion of form for the

15 annual standard, but the preliminary

16 conclusions we reached on indicator, and I

17 don't know if you've had a chance to look at

18 it, basically are reaffirming what we have

19 done in the past, recognizing that there is

20 new information to look at, to inform our

21 understanding of alternative indicators, but

22 not enough at this point in our preliminary

Page 327

1 conclusions to reach us to move beyond a mass2 based standard.

3 The same with the averaging time,

4 that where we see still evidence to support

5 the 24-hour and annual standard, that the

6 other averaging times that we have considered,

7 we felt that the information at this point was

8 insufficient to support alternative averaging

9 times.

10 So you will see the discussion

11 later on really focus on level, and what we

12 have tried to do is to outline our approach

13 with how we address the evidence based and the

14 risk-based considerations and discuss, if we

15 put more weight on this part of the

16 information, it would lead us toward this

17 conclusion; if we put more weight on this part

18 of the evidence or the risk information, it

19 would lead us to this conclusion.

20 So we have tried to balance that

21 discussion out. Namely, I think you will see

22 that in Section 2.3.6 where we talk about the

Page 328

1 interplay between the two standards.

2 DR. MARTIN: If I could just add

3 to that.

4 DR. LIPPMANN: An artful way of

5 not answering my question.

6 DR. MARTIN: I do want to speak

7 more specifically to your question about

8 margin of safety.

9 What you will not find in this

10 first draft discussion is a lot of discussion

11 about margin of safety. There is certainly

12 not going to be any formula, and there never

13 will be and, if you look at past history, we

14 all know there never has been. 

15 What the past decisions -- the

16 approach used in past decisions and likely the

17 approach used in this decision is a balancing

18 of where do I see the strongest evidence, at

19 what point do that evidence become uncertain,

20 do I see concerns about susceptible

21 populations that might not be part of the

22 strongest body of evidence, do I have reason

Page 329

1 to think I need to go somewhat lower in a

2 level of a standard in order to provide

3 protection for susceptible populations?

4 There are shades of gray issues,

5 but in this first pass through, what we were

6 trying to do was outline different ways of

7 thinking about the information from the

8 studies and how that might translate into a

9 basis for a standard; and based on, hopefully,

10 input from you all to shed further thinking on

11 those approaches, in the second draft I think

12 we can be more sharp, more sharply address the

13 question of over what ranges do we think we

14 have a stronger basis, and then to what extent

15 might one go beyond, and what would be the

16 additional protections that you are trying to

17 create this margin of safety to protect

18 against? Is it simply to protect against

19 generalized uncertainties or is it to protect

20 against specific types of effects for which we

21 might have far less information, but

22 continuing concerns that may be setting
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1 something at the same level as mortality

2 protection wouldn't be equally protective.

3 So I think we need to take a first

4 pass through and get your feedback on this

5 first draft, and then sharpen that discussion

6 in the second draft.

7 DR. LIPPMANN: Well, I hope then

8 that, perhaps with the meeting, the

9 teleconference meeting where we discuss this

10 first draft, we could tee up the remaining

11 policy related issues before you get too

12 serious a final writing on it.

13 CHAIRMAN SAMET: But I think the

14 point about when we see some of the really

15 heart of the matter issues in the first draft,

16 second draft, I think, is critical, because

17 this is our first draft, and we know there are

18 things left to be done, some of which are the

19 most critical. 

20 So in effect, we will have one

21 shot at commenting on them. I do have a

22 question about sort of these charge questions

Page 331

1 1 and 2, and you might just -- in helping us

2 think about addressing them, when you read the

3 document, as you said, it is way too long just

4 to get it in, and how much of the text -- in

5 other words, you have gone back and pulled

6 material on specific studies you found

7 particularly relevant.

8 Just in terms of our understanding

9 of where that text comes from, are you just

10 sort of lifting it out of the ISA or the risk

11 assessment or is this -- because there are

12 segments of text that are quite detailed about

13 individual studies and so on. Is this sort of

14 stuff we have already seen? Is it a rewrite?

15 MS. HASSETT-SIPPLE: Well, where

16 it is exactly lifted from, the ISA or the risk

17 assessment document, it should be in

18 quotations. So that gives you a clue. But we

19 have not brought in any new evidence beyond

20 what is discussed in the integrated science

21 assessment or the additional analyses that

22 have been done or air quality analyses, not

Page 332

1 additional risk-based analyses.

2 So the evidence really builds upon

3 the information in the ISA and the information

4 that we put into Chapters 2, 3, 4 and 5,

5 actually. It is just enough to help us tell

6 the story, to be able to present enough

7 information to support the rationale.

8 CHAIRMAN SAMET: Okay. So for

9 example, I am looking at page 239 where there

10 is a whole paragraph on a number of new multi11 city and single-city studies, and lists out

12 all these studies. Some of them even come

13 from Harvard. But I guess my point is, none

14 of this is in quotes, and so I just really

15 want to know -- you know, this looks like the

16 kind of material we have been reading a lot of

17 in the other documents. 

18 Are you sort of reformulating all

19 this or, when you come to these sort of

20 descriptive things -- and same is true for the

21 risk assessment -- are you just sort of moving

22 things over that are particularly important,

Page 333

1 and then, if so, how do you decide?

2 I think that would be something

3 useful as we look at the structure and

4 content.

5 MS. HASSETT-SIPPLE: So I think,

6 particularly in this section which is

7 associations with short-term PM2.5 exposures,

8 and there is an analogous section for

9 associations with long-term PM2.5 exposures

10 that begins on 2.2-34, what we are really

11 looking at here was, in addition to the

12 information from the ISA, to bring in more

13 information about what we knew about the air

14 quality distributions evaluating those

15 studies.

16 So I mentioned this morning that

17 in CNO EPS -- and CNO used information

18 reported in the studies, air quality

19 information reported in studies. We needed

20 more information on the air quality

21 distributions, and we sent out a request for

22 information to a number of study authors,
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1 including many people in this room.

2 We used that information. Some of

3 that was reported in the ISA, and then we are

4 bringing in even additional information here

5 on the air quality levels associated with the

6 studies.

7 CHAIRMAN SAMET: Let me just pose

8 a question to the Panel. If you look, for

9 example, at Charge Question 2 -- and we have 

10 been working with EPA staff to try and bring

11 as much specificity as possible to these

12 charge questions. 

13 So these kinds of questions: To

14 what extent does the Panel find that the first

15 draft PA accurately reflects and clearly

16 communicates the currently available -- blah17 blah-blah, including important uncertainties

18 as characterized in the final ISA?

19 So I know what you mean, I think,

20 but do we want more specificity in these kinds

21 of charge questions? We had pushed back a

22 little bit to say give us a little more about

Page 335

1 what you mean, and part of this does relate to

2 how much information should get moved over the

3 length and content.

4 So if we are left with this, is

5 our question could there be better

6 communication, should there be shorter

7 communication, should there be more something

8 else? 

9 So let me just throw that out for

10 discussion, because we are going to end up

11 answering this in some way. The answer is not

12 45 percent or 85 percent. It is something,

13 you know, of some different sort from that. 

14 So this is a chance to bring some greater

15 specificity here.

16 MS. HASSETT-SIPPLE: And I think,

17 as Karen said this morning, we recognize that

18 this is longer than you wanted. I think Dr.

19 Brain actually said 100 pages, and this

20 chapter alone is 100 pages. 

21 So where you can give us guidance

22 on what is most useful and what is information

Page 336

1 that you feel is not useful for the policy

2 assessment that might be extracted or

3 tightened up quite a bit, that would be very

4 helpful feedback for us.

5 CHAIRMAN SAMET: Rogene, do you

6 want to comment on this sort of charge

7 question? You have seen a few of these in

8 your day.

9 DR. HENDERSON: Some of the

10 questions -- they are so broad. It is like a

11 motherhood statement, and so it is easy to

12 say, it was all right, you know, without

13 taking it seriously.

14 So I think the more specific your

15 question can be about the information you

16 really want from us, the better our answers

17 will be, because -- I mean, that is my --

18 CHAIRMAN SAMET: Yes. I think

19 here, for example, you could certainly say,

20 you know, is the right amount of information

21 being transferred? What is the right amount

22 of information? Are we too much, too little? 

Page 337

1 Maybe we could just try and bring some

2 specificity here.

3 I think this would be helpful to

4 us as we write our review, so we write as

5 focused as possible, I think. 

6 DR. HENDERSON: It depends on what

7 you want from us. If you want specific

8 information, you had better ask it.

9 DR. MARTIN: If we think about

10 Chapter 2, where you have pointed us to a

11 page, and we think about this kind of

12 technical content question, one way to make

13 the questions more specific is to say: In the

14 discussion of long term exposure studies, does

15 the Panel agree that appropriate -- that this

16 is an appropriate set of studies to call out

17 for specific attention? Would the Panel

18 recommend -- you know, what are the Panel's

19 views about giving equal weight to these

20 studies? Are there some studies that should

21 be given greater emphasis for whatever reason,

22 other studies given less emphasis?
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1 One could be specific in that way

2 and, if that is more helpful to you to help --

3 CHAIRMAN SAMET: Well, I think

4 that the question is how to --

5 (Simultaneous speaking.)

6 CHAIRMAN SAMET: -- and I think

7 again, I think we have been able to work

8 together to try and get these sharper. I

9 think these are -- I think this will come up

10 as we turn the page and look at some of the

11 others. Mort?

12 DR. LIPPMANN: Two things. One,

13 we have less than a month, almost a month but

14 less than a month, before we get into a review

15 session. What can we as individuals do in

16 that time to facilitate the formal meeting?

17 If some of us want to go through

18 this paragraph by paragraph, even line by

19 line, and make very specific comments, how

20 would Jonathan then organize integrating that

21 in time? 

22 Should we be circulating our

Page 339

1 individual comments to each other in advance? 

2 of course, that has not been the recommended

3 procedure for most meetings. I have ignored

4 that and done it sometimes.

5 Considering that we have under a

6 month to get ready for this meeting, what

7 should we be doing?

8 CHAIRMAN SAMET: So now we will

9 certainly come back to have a discussion about

10 our approach and getting some assignments

11 made, because you are right. The time is

12 short. This is, of course, our first view of

13 both the draft and these charge questions, and

14 I think by the time we leave tomorrow, we

15 should be at a point where we have identified

16 who will be taking on what.

17 I am sure it would be helpful to

18 EPA that, as we all read through this, if we

19 have specific comments to make, we should and,

20 I am sure, will make those comments,

21 regardless of who is charged with specific

22 responses.

Page 340

1 I think what I am most concerned

2 about now is trying to make sure we have some

3 sharp enough questions for this document that

4 we can really answer them. I think, if you

5 look at number 3, approach, 3a: Example, what

6 are the Panel's views with regard to general

7 approach of considering and integrating

8 evidence base and risk-based considerations?

9 You know, taken at its most

10 general level, if we gave you our views, we

11 would answer the question. I think you really

12 want to know sort of have you taken the right

13 general approaches as set out, as described.

14 I think, in part, because this is

15 a public process and we are responding to

16 questions from you, that it should be clear

17 about what is going on. 

18 We have answered these kinds of

19 questions enough to be able to understand

20 probably what you are really getting at, but

21 I don't think the question exactly says. It

22 is sort of code, and I think we should try and

Page 341

1 do a little better than that.

2 If you ask the Panel's views, you

3 could probably get two views from each person,

4 if you wanted. So I think, again, it is just

5 a question of what do you want out of this?

6 DR. LIPPMANN: Jon, one follow-up,

7 specifically to what Karen just said. The

8 risk assessment document has already decided

9 which studies are appropriate for risk

10 assessment. So are we to say some of these

11 are not influential on policy choices? Are we

12 locked into having the relevant studies being

13 those that were relied on in the risk

14 assessment?

15 MS. HASSETT-SIPPLE: I think that

16 you will see that the studies are important

17 for the quantitative risk assessment are

18 studies that are also important for the other

19 space considerations.

20 We are also looking at a broader

21 range of studies that for -- in the criteria

22 to select studies that would be useful for the
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1 quantitative risk assessment, some of those

2 studies might have fallen out, one, because we

3 didn't have good baseline incidence data for

4 the population being studied. 

5 You know, there may be a number of

6 different reasons, but the evidence-based

7 considerations in the policy assessment takes

8 a broader look at the body of scientific

9 evidence, but it would include all of the

10 studies that were considered in the

11 quantitative risk assessment.

12 DR. LIPPMANN: In other words, we

13 start as a given with those that have been

14 vetted and used in the risk assessment, but

15 can suggest that other studies can be also

16 considered vital to the policy assessment.

17 CHAIRMAN SAMET: Joe.

18 DR. BRAIN: I guess my question is

19 -- and maybe this should be a charge question

20 -- does the document do what it is intended to

21 do? So the question is, you know, what is it

22 intended to do? I guess it is a summary for

Page 343

1 the Administrator and for the public to read

2 and help them make a decision.

3 So it seems to me it is now so

4 long and complicated. I mean, do we really

5 expect the Administrator to look through all

6 this and come to a conclusion? 

7 I mean, shouldn't it be 15 or 20

8 pages, and shouldn't it clearly -- seems to me

9 somewhere there should be a clear statement,

10 what is the current standard; what are the

11 alternative standards that you should

12 consider, and then a really very brief summary

13 of the evidence supporting these different

14 alternatives where, if she wants more, the

15 public wants more, then point them back to the

16 ISA or to the REA.

17 I am just sort of -- I guess

18 another question is, you know, is there an

19 ideal format for what has really worked in the

20 past for the Administrator to make a decision?

21 What do Administrators like?

22 This seems too long, too detailed,

Page 344

1 not sharp and pointed enough to really serve

2 those purposes, or am I wrong? I don't know.

3 DR. MARTIN: I would like to speak

4 to that. The audience for this document right

5 now is not the Administrator. I mean, this is

6 a set of preliminary staff conclusions that we

7 have documented that lays out different ways

8 of thinking about the information, and a full

9 array of information, and we are coming to you

10 and the public to solicit your input. This

11 isn't for the Administrator.

12 DR. BRAIN: Then there is

13 something later?

14 DR. MARTIN: We wouldn't talk to

15 her until we have a final document that has

16 been through the review of this committee,

17 that has then received public comment, so that

18 we can have a more well-informed set of views

19 to present to her, and to present to her your

20 views on this.

21 So I wouldn't think about this

22 document as the set-up for the Administrator

Page 345

1 making the decision. This document is to set

2 up different approaches to creating a

3 rationale for going from the science, the

4 risks, to standards, and that we need, in our

5 opinion, to lay it out fully enough to get

6 well informed input from you all.

7 If all we did was present summary

8 conclusions, what we would then have to share

9 with you is just do you agree with our summary

10 conclusions, and it becomes more a matter of

11 intuition than a matter of a well-reasoned

12 approach to going from the underlying studies

13 to the basis for a standard.

14 So we feel pretty strongly that we

15 need to put enough in this document so that we

16 can reasonably elicit from you your thinking

17 on rationales, and to create a very summary

18 form, in the end, of course, that is what gets

19 communicated to her. But it will be based on

20 having gone through this process first so that

21 we have a better understanding of what it is

22 we feel is most appropriate to communicate.
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1 DR. BRAIN: So I am learning. So

2 there is a fourth document that will follow

3 this?

4 DR. MARTIN: There are internal --

5 DR. BRAIN: Because that sounds

6 like the really important one. I could also

7 imagine you would look at that document and

8 say, you know, how do I then marshal evidence

9 to support the final recommendations that does

10 go to Lisa Jackson.

11 DR. MARTIN: What will go to her

12 will be reflective -- obviously, she will get

13 a copy of the document, but we go through an

14 internal decision making process that includes

15 a series of briefings that goes up through

16 agency management, through the head of the Air

17 Office, through the Administrator, and those

18 briefing packages do a lot like what you are

19 describing: Here is what the standard is. 

20 This is what we said before. This is the new

21 evidence. This is how we have thought about

22 the evidence. These are our -- a range of

Page 347

1 considered opinions. This is what CASAC has

2 to say. This is what the public has said.

3 It provides that kind of overview,

4 but it has this as the underpinnings for it. 

5 So that when we get questions about, well, why

6 did you say that, why did they advise that, we

7 can point to the basis for it and ground it in

8 the information that we have. That is how the

9 process works.

10 DR. BRAIN: But even there,

11 wouldn't it be helpful to have a simple

12 statement somewhere in here at the beginning

13 or the end of the current standard, you know,

14 which -- and then the alternative standards. 

15 I mean, I guess I also sort of missed the

16 sunset chapter that sort of pulled the whole

17 document together. That maybe didn't prejudge

18 the next level that you are talking about, but

19 at least sort of laid out -- you know, it

20 didn't give the final -- how the novel ended,

21 but it said, you know, here are three or four

22 possible ways the novel will end.

Page 348

1 It is hard to see the forest for

2 the trees still.

3 DR. MARTIN: And it also --

4 obviously, you need the opportunity to really

5 read through the document to better understand

6 what is here. Each chapter ends with a very

7 succinct summary of what preliminary

8 conclusions we have reached with regard to

9 adequacy, indicator, time level and form. 

10 We see that the primary standards

11 for fine particles, standards for thoracic

12 coarse particles, visibility standards as

13 being discrete decisions that need to be made,

14 but each of those chapters ends with a very

15 succinct summary of the preliminary

16 conclusions presented in that chapter.

17 DR. HENDERSON: I have a question. 

18 I think what Joe is describing is what we used

19 to see in the staff paper, and I have seen --

20 I have heard the policy assessment described

21 as the new staff paper. In some ways, I see

22 that in here.

Page 349

1 There are a lot of things that I

2 heard Joe asking for that are here. You know,

3 the very good introduction gives you the past

4 history, et cetera, and gives you the approach

5 for choosing a primary standard, and adequacy

6 of current standard.

7 I like the organization, but if

8 this -- this isn't the staff paper. You

9 sounded as if there was going to be another

10 document after this that would summarize it

11 more like the staff paper where the last

12 chapter says, you know, these are the

13 alternatives that we are recommending for

14 consideration by the Administrator.

15 So if this isn't that, we don't

16 get to see what is being recommended.

17 DR. MARTIN: But, in fact, this is

18 that, and each chapter does end with a

19 succinct summary, just as the staff papers

20 did.

21 DR. HENDERSON: Okay. So there

22 were summaries. I had a chance to look it
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1 over, speed read it, and I like the

2 organization of it.

3 DR. MARTIN: And if, in the end,

4 by the time we make this document final, it is

5 a very simple matter to create a two-page

6 overarching summary of the conclusions on each

7 of the four areas and put that right up front. 

8 That is simply copying the bottom lines from

9 each chapter, and pulling them together. That

10 is a very easy thing to do.

11 DR. HENDERSON: I think that --

12 DR. MARTIN: That we have to

13 decide based on input, what the appropriate

14 the conclusions are.

15 DR. HENDERSON: Okay. Well, I

16 think that would be good. It would be a good

17 summary to have. But I did like the

18 organization of it.

19 CHAIRMAN SAMET: As I said, there

20 is a fine line between discussing the charge

21 questions and discussing the document.

22 DR. HENDERSON: I'm so sorry.

Page 351

1 CHAIRMAN SAMET: No, no, no. That

2 is all right. We haven't really gotten to the

3 charge questions yet, because I think there

4 are some thing is here we should discuss,

5 because actually, the more I look at them, the

6 more I am concerned that they are a bit too

7 vague, too long, too rambling, and that some

8 of them -- really, I think it would be helpful

9 for you to do some sharpening, and we have

10 done this in the past, again, in back and

11 forth. 

12 We haven't done that yet, but as I

13 look at them -- and again, I think part of

14 this is just to say that here was the question

15 that we set out to answer, and here is our

16 answer. And if you can't quite tell what the

17 question is about, I think it is a process

18 issue and one where, I think -- and again, I

19 am just sort of staring at 4b.

20 If everybody can just look at 4b,

21 now I think there are some important ideas in

22 there, but even Sverre could not ferret that

Page 352

1 question out.

2 DR. VEDAL: Well, it would be a

3 long answer.

4 CHAIRMAN SAMET: It would be a

5 long answer. But again, we are getting to a

6 very important set of issues there, but I

7 think, if you are asking us, you know, has the

8 quantitative -- what are you asking us in

9 that? I am not going to try and translate it.

10 DR. MARTIN: In your view, does

11 the quantitative risk assessment provide

12 support for the conclusion that the current

13 set of standards is not adequately health

14 protective.

15 CHAIRMAN SAMET: But that is not

16 what this question says -- "can reasonably be

17 judged to be" --

18 DR. MARTIN: That is what the

19 first half of this says.

20 CHAIRMAN SAMET: Well, there is

21 another one almost like what you said that

22 comes earlier. That is the only reason I am -

Page 353

1 - so I do think we should probably focus a

2 little bit on this. Chris, you had a comment?

3 DR. FREY: Well, it was in the

4 vein of this previous conversation, just a

5 sort of process question that might help me s

6 I review this tonight.

7 What is the relationship, if any,

8 between the policy assessment document and the

9 text that ultimately goes into the Federal

10 Register Notice of the proposed rulemaking? 

11 Is it closely related or totally different?

12 DR. MARTIN: It is often very

13 closely related.

14 DR. FREY: Okay. So we should

15 think of the audience --

16 DR. MARTIN: If you look at past

17 final staff papers and then read the Federal

18 Register proposal, you will find a whole lot

19 of stuff that is there, and that is one of the

20 reasons why we want to keep enough detail in

21 here so that, when we prepare a rulemaking

22 package, we aren't going out with untested
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Page 354

1 presentations of information.

2 We are drawing from something that

3 truly has been vetted through this Panel and

4 with the public, and you will see a lot of

5 similarities.

6 DR. FREY: So you want -- so I am

7 interpreting, you want something that is kind

8 of self-supporting with enough information

9 that a member of the public could read that,

10 and it is a coherent story, and I think some

11 of the push-back you are hearing from our

12 group is, well, a lot of this is in ISA or the

13 REA, why not just cite those and then move on.

14 DR. MARTIN: I think that -- I am

15 really glad you asked that question, because

16 part of our motivation for doing the document

17 this way is we are looking for a vehicle to

18 then create a proposed rulemaking document,

19 and that rulemaking document has to convey in

20 one document for the public where have we

21 been, where are we now, what did we look at,

22 what was this based on, what is the basis for

Page 355

1 the decision, what did CASAC say about it.

2 All those things are in it, and if

3 we make this document so thin because you all

4 have read the other underlying documents,

5 therefore, you don't need the repetition, now

6 then we have to create yet a new document when

7 we go to move forward with a proposal package,

8 and that won't have had the benefit of your

9 insights on how it was put together.

10 So that is what do. I should have

11 thought to say that more clearly earlier on. 

12 That might have been more helpful. So I am

13 glad you asked that question.

14 CHAIRMAN SAMET: Helen.

15 DR. SUH: I have to say I am

16 confused still, partly because of my

17 preconceived notions prior to this what this

18 was meant to be. Now I am rethinking it a

19 little bit.

20 Partly, I think it is that the

21 PM2.5 body of evidence -- it has been carried

22 through quite a bit, because it is also in the

Page 356

1 risk assessment. So there is quite a lot of

2 discussion about what were the studies that

3 were the most important and how everything was

4 carried through.

5 There is a little bit more of a

6 story where I could see the summary might be

7 more informative. But for the coarse

8 particles, quite a few things got tabled. It

9 was not included in the risk assessment. So

10 they got tabled, and they said in the risk

11 assessment supposedly that they would be

12 discussed in the policy assessment.

13 So I was expecting in some way a

14 little bit more analysis, so that the thoracic

15 coarse part would be treated a little

16 differently than the fine part. So it seemed

17 -- and I am trying to put that together with

18 what you have just talked about and how that

19 really fits, because then the -- because I was

20 expecting a little bit more, and now this has

21 the PM-10 as an indicator, for example, and

22 takes the scientific evidence perhaps one step

Page 357

1 farther.

2 I don't know if that belongs here

3 or that doesn't belong here or -- because then

4 that is not really just a summary or a drawing

5 forth of certain information. It is really a

6 new something here.

7 DR. JENKINS: So let me ask a

8 clarifying question. Are you saying it is

9 because you have looked at the Chapter 3 and

10 think that there needs to be more there or are

11 you just saying --

12 DR. SUH: No, I am just not sure. 

13 I am just asking you.

14 DR. JENKINS: Okay. Well, I think

15 that with your example of the indicator, I

16 think we do have a relatively extensive

17 discussion of the PM-10 indicator and its

18 appropriateness for a standard that is meant

19 to protect against thoracic coarse particles.

20 DR. SUH: In the policy

21 assessment?

22 DR. JENKINS: Yes. Yes, in the
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Page 358

1 policy assessment. That sort of discussion is

2 not in there. So I mean, one thing from my

3 perspective on the thoracic coarse particles,

4 you know, all the information, the basic

5 information, of course, is contained in the 

6 ISA, but it is oftentimes not brought together

7 in the most policy relevant context.

8 So one of the things that we try

9 to do in this document is to bring those --

10 all those studies together so that they can

11 inform specific policy questions.

12 So even though there may be some

13 restatement of -- re-description of some of

14 the studies, we are trying to bring them

15 together within the context of answering the

16 specific policy questions. 

17 So I think -- well, I mean, we can

18 wait and see your reaction after you have had

19 a chance to look at it, but I think there is

20 some amount of detail in there, in my opinion,

21 enough detail at least to draw some informed

22 conclusions.

Page 359

1 DR. SUH: The reason I asked this

2 is in one of the charge questions -- it was

3 like 9b -- it says -- basically, it says that

4 overall -- in considering the air quality

5 information as well as the overall body of

6 evidence and associated uncertainties, staff's

7 preliminary conclusion is that, depending on

8 the emphasis placed on the different aspects

9 of the evidence and uncertainties, it could be

10 judged that the PM standard does or does not

11 provide adequate protection.

12 DR. JENKINS: Is that not specific

13 enough for you?

14 DR. SUH: But then it says what do

15 you view this preliminary conclusion -- which

16 is, to me, not really a conclusion. I don't

17 know.

18 DR. JENKINS: Well, I think --

19 DR. SUH: I guess I am trying to

20 figure out how -- you know, from the ISA how

21 can you take that information, bring it

22 forward, and then even -- I guess I am not

Page 360

1 sure how you can provide -- do you understand

2 what I am saying? 

3 DR. JENKINS: Yes, and I think

4 what you have just pointed out is due in part

5 to the fact that this is a first draft

6 document, and we have initial preliminary

7 conclusions. We haven't drawn final

8 conclusions, and we are looking for feedback

9 from the committee to help us inform those

10 final conclusions that will be included in the

11 final document, but what that part of the

12 chapter lays out that you just highlighted

13 there is it lays out the evidence and the air

14 quality information and its associated

15 uncertainties and basically says that, to the

16 extent that you emphasize X, Y and Z, well, if

17 the Administrator is going to place emphasis

18 on these considerations, then a justifiable

19 conclusion would be that the current standard

20 does not provide adequate health protection.

21 On the other hand, you know, we

22 have all these uncertainties associated with

Page 361

1 the evidence. So to the extent those

2 uncertainties are emphasized, a different

3 conclusion could be reached. 

4 So one of the things we are

5 looking for is feedback on, well, you know,

6 what is the appropriate weight to place on

7 some of these uncertainties, which are brought

8 out in the document itself, versus the

9 evidence, which is again discussed a bit in

10 the document itself, and in the context of

11 those air quality concentrations, which again

12 are included in the document?

13 So I think that part of that is --

14 I think part of this -- I think the

15 conclusions of the document will be sharpened

16 as we go through the process, the iterative

17 process of revising it through multiple

18 drafts. So I would fully expect us to have a

19 sharper conclusion in the final document that

20 we have in the first draft document, and I

21 think that final conclusion will be informed

22 in large part by what we hear from this group.
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Page 362

1 DR. SUH: So are you asking the

2 Panel to say which way we think you should go

3 or is it --

4 DR. JENKINS: I think that, you

5 know, if you -- sort of the last sentence on

6 that question: What are the Panel's views on

7 this preliminary conclusion on the alternative

8 approaches to considering the evidence and its

9 uncertainties, and on the adequacy of the

10 current PM-10 standard?

11 So, I think we would be looking

12 for feedback on all of that.

13 CHAIRMAN SAMET: So just a

14 comment, and then I will get to you, Frank. 

15 We do have a month to go before reviewing

16 this. The quality of the review -- we have

17 used the charge questions as a guide to our

18 reviews.

19 In my mind, again, taking a look

20 at them now, the charge questions themselves

21 are not yet in an acceptable form, in that

22 they need to be sharpened and focused, and 

Page 363

1 that that would need to be done very quickly.

2 I am not sure that we can sit here

3 as a group and rewrite the charge questions

4 with you or for you, but I would like to see -

5 - and I think it is urgent that we have a far

6 sharper group of charge questions by the

7 week's end. 

8 I will be happy to provide you

9 with my comments, as I have done previously,

10 and I think the kinds of comments that I made

11 before about the lack of specificity in the

12 charge questions, all the issues that have

13 provoked those comments are sitting in this

14 batch that you have given us now.

15 So I do think they really do need

16 to be sharpened. I think we as a group need

17 to think about whether all the key issues are

18 addressed. 

19 I think it is helpful to help us

20 better understand how this new document fits

21 in and what it is supposed to do, because I

22 think that purpose -- and I think Joe and

Page 364

1 others have talked about that -- is important,

2 but I do think -- I think these comments do

3 need some back and forth, and there is

4 probably no reason to pick on one or another. 

5 I will give you some general feedback. Frank?

6 DR. SPEIZER: Well, I wanted to

7 raise a point that will lead to frustration

8 unless it is fixed. It looks to me as though

9 the charge questions were almost written by

10 somebody who has not read the preliminary

11 draft.

12 Charge Question 8 talks about

13 Sections 2.4.1 and 2.5.1 and 2.4.2 and 2.5.2. 

14 Those sections are not written yet in the

15 preliminary document. So I don't know. You

16 are going to make a lot of frustration if you

17 leave it the way it is.

18 MS. HASSETT-SIPPLE: Actually, Dr.

19 Speizer, that is actually a mistake. That

20 should be 2.3.4.1, 2.3.5.1. So those are the

21 evidence-based considerations.

22 DR. SPEIZER: Okay. All right. 

Page 365

1 But then I come to the specifics of the

2 question. I mean, first of all, that has got

3 to be cleaned up.

4 The question says: what are the

5 Panel's views on the insights that can be

6 gained from -- well, I think we are beyond

7 that. We want to know what insights you have

8 used, and we will critique those. But for us

9 to at this stage try to give you insights as

10 to what you ought to be thinking about seems

11 like you are slowing the process down.

12 We want to read what you have done

13 and comment on it, not at this stage give you

14 new insights to think about. Again, this is

15 just another example of how we have to sharpen

16 the questions.

17 CHAIRMAN SAMET: Yes. Joe?

18 DR. BRAIN: Just one other thing

19 that I would like, thinking of the public or

20 potentially the Administrator, is, can you

21 succinctly somewhere at the beginning or the

22 end tell me what has changed in the last five
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Page 366

1 years, so we are looking at this -- so what is

2 the greater clarity about? What uncertainties

3 have been reduced?

4 It is sort of scattered in there,

5 but it seems to me a nice -- I am looking for

6 some macroscopic, high-level summaries of what

7 is there and that seems to me one example. 

8 You know, do you carefully, clearly lay out

9 where are we now in terms of how that

10 contrasts to where we were five years ago or

11 ten years ago when some of these standards

12 were initially promulgated?

13 DR. HENDERSON: I am wondering if

14 you couldn't simply -- I am just looking at

15 how you simplify these, and you could almost

16 just use the outline and say, you know, what

17 is the -- because the Panel agreed with the

18 reasoning on the adequacy for the current

19 suite of standards, but sort of getting that

20 whole -- maybe see -- and do you agree with

21 the indicators, because that is what people

22 are thinking about. But when you have all of

Page 367

1 these words in there, you kind of get lost.

2 CHAIRMAN SAMET: Mort?

3 DR. LIPPMANN: We are coming to

4 grips with the level of the standard and the

5 impact of the alternate standard. I don't

6 think we have come to grips with the ranges of

7 responses that are indicated in the

8 literature. 

9 For the short-term standard, we

10 have huge differences in the indicated

11 response from city to city among 15 cities. 

12 In the long-term standard related to

13 mortality, we have coefficients that range

14 over a very wide range of coefficient, with

15 the one -- sort of the index standard being an

16 outlier, so to speak, among the various

17 studies.

18 So what is the Administrator

19 supposed to decide about protecting the public

20 in terms of the magnitude of effect? If the

21 ACS cohort is the basis, how then does she

22 deal with the fact that all of the other

Page 368

1 cohorts indicate significantly bigger impact?

2 It is hard to talk about margin of

3 safety in that context when you are taking the

4 one with the least impact. Is the six cities

5 a low-ball estimate because of things we

6 discussed earlier or is it really the best one

7 available and what is wrong then with the

8 others which we have judged to be

9 scientifically credible but give different

10 results?

11 I think this is where the rubber

12 is going to hit the road in terms of the

13 adequacy of the standards, and I don't see any

14 questions that we are supposed to comment on

15 with regard to what coefficients should be

16 used.

17 CHAIRMAN SAMET: Bob?

18 DR. PHALEN: Rogene's point is too

19 important to ignore. I just wanted to comment

20 on Rogene's point because as I look at this,

21 I was intimidated by it. I don't have time to

22 unscramble all of these words, and if we look

Page 369

1 at technical comment 2a, that can be reduced

2 to two lines.

3 We didn't have to say the

4 discussion of the health and welfare effects

5 evidence draws from the currently available

6 scientific so-and-so presented in the ISA,

7 which included consideration of information

8 from previous reviews. 

9 We know that. Eliminate that, and

10 I would eliminate to what extent, and I would

11 just ask the question: does the Panel find

12 that this first draft PA accurately reflects

13 and clearly communicates available health and

14 welfare effects evidence from PM, including

15 important uncertainties, period, because now

16 it says as characterized in the final ISA.

17 So before we make a comment, I

18 guess we would have to go back and re-read the

19 ISA, which is what, 500 pages? So I would

20 reduce that, too, to one sentence, and then it

21 is more clear, it is less ambiguous, and it

22 easy to deal with.
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Page 370

1 CHAIRMAN SAMET: I mean, I think

2 you are highlighting one example of the many

3 problems with the charge questions and I think

4 both for our efficiency and our ability to be

5 helpful, I think it is important to sharpen

6 these.

7 I think, if we could just agree on

8 how that is going to get done quickly, I think

9 that is what is critical. Ed?

10 MR. AVOL: I have a question to

11 follow up on the comment that both Beth and

12 Karen made earlier. That was on this notion

13 that in the policy assessment you have not

14 only -- you were looking at other -- a broader

15 wealth of evidence, I think was the way you

16 might have phrased it or something to that

17 extent, to draw in to inform for what was in

18 the document.

19 I haven't looked at the document 

20 yet. So I have to plead ignorant here, but it

21 seems to me that the -- I mean, my

22 understanding was the policy assessment was

Page 371

1 sort of built upon the former documents. 

2 That is, it sort of took the hard

3 work and the long time and the careful

4 scrutiny that was put into the risk

5 assessments and the judgments from that about

6 what were the appropriate studies to use and

7 which ones had validity and what the decisions

8 were for those, and those would be carried

9 forward.

10 It sounds like you are willing to

11 consider other -- the other evidence that may

12 or may not have been in the previous documents

13 or that you may reorder or change what is in

14 the previous documents.

15 So my question is: as you go

16 through that, are you going to highlight or

17 comment on why you chose to do what you did?

18 CHAIRMAN SAMET: Actually, don't

19 answer yet. Whoever is on the line, can you

20 mute -- can you hear us? If you could mute it

21 or just disconnect?

22 DR. STALLWORTH: Is there anyone

Page 372

1 on the line? Okay, let's just hang up. Let's

2 just hang up the conference line.

3 MS. HASSETT-SIPPLE: So, Ed, just

4 to clarify that, when I made the comment that

5 we take a broader look at the body of

6 scientific evidence, it is all information

7 that is contained in Integrated Science

8 Assessment but may not, for a variety of

9 reasons, have been considered in the

10 quantitative risk assessment.

11 So if we focus on the long-term

12 exposure studies -- for example, the

13 quantitative risk assessment focused on the

14 ACS, the most recent ACS study, Krewski 2009,

15 and the sensitivity analysis with the most

16 recent Harvard Six Cities Study late in 2006. 

17 But here we also look at information from the

18 Women's Health Initiative study in early 2007. 

19 We looked at the information on the Children's

20 Health -- the Southern California Children's

21 Health study. We looked at information on the

22 cystic fibrosis study that Goss did in 2004. 

Page 373

1 So a much broader range of information to

2 inform our understanding of whether or not the

3 current standards provide adequate protection

4 and, if not, what alternative standards should

5 be looked at.

6 So I think, if you can look at --

7 If you can take the time to look at how we

8 have laid out the approach for fine particles

9 in Section 2.1.3, and the different types of

10 information on how we consider them and how we

11 integrate the evidence and the risk-based

12 information, and follow it all the way

13 through, but then in Section 2.3.6, where we

14 come back and integrate the risks, because we

15 look at the evidence and we look at the risks

16 to inform our understanding of adequacy and

17 alternative standards, and then we pull them

18 back together again.

19 So if you can just be patient and

20 look and give us feedback on how we pulled it

21 together. You know, it is probably not

22 perfect. It is a first draft, and it is long. 
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1 I think we have tried to take a very broad

2 look at the evidence and expect that we will

3 be narrowing and tightening and sharpening our

4 approach as we get feedback from you and from

5 the public, but the first cut is a broad look. 

6 But as far as the body of scientific evidence,

7 we are not bringing in anything that wasn't

8 discussed in the Integrated Science

9 Assessment. 

10 DR. HENDERSON: Jon, I was

11 wondering. An idea struck me. I think we are

12 commiserating over too -- I am wondering. 

13 When anyone reads this -- a policy assessment

14 document, they will be burning to put down

15 certain points, and they can write those down.

16 It is an extra burden then to try

17 to fit those comments under your charge

18 question. Is it of any benefit to you for us

19 to just write down what our concerns are about

20 the document without fitting them into the

21 structure of your charge document -- charge

22 questions?

Page 375

1 DR. MARTIN: Let me just respond

2 to that. There is clearly a tension between

3 trying to frame questions -- since you do use

4 these questions to organize your discussion,

5 there is clearly the tension between trying to

6 frame them open-endedly enough so that you are

7 encouraged to comment on those things that you

8 thought were important to comment on, which we

9 might not, in all cases, be able to know in

10 advance what that might be versus providing

11 enough specificity that you can give

12 meaningful comments.

13 What we are hearing from you now

14 is that more specificity would be better. 

15 That is clear, and more simple expressions of

16 the questions would be better. But in the

17 end, we don't want to preclude your commenting

18 more broadly to the extent you feel it's

19 appropriate.

20 CHAIRMAN SAMET: And I am sure

21 individuals will and the group will. I can't

22 imagine being concerned about it.

Page 376

1 DR. SPEIZER: I would be concerned

2 if your questions became so specific that we

3 could answer them yes or no, because that

4 would not help you at all.

5 DR. MARTIN: I don't want yes or

6 no answers, which is one reason why you see

7 things like to what extent. I don't want to

8 say is this a -- do you agree and just get a

9 yes or no answer. That is honestly not

10 particularly useful if you don't opine as to

11 the reasoning behind your answer.

12 CHAIRMAN SAMET: But we do want

13 answerable questions and I think that is where

14 you need to get. 

15 Let's take the remaining four

16 minutes and discuss a process that is going to

17 lead to better questions and quickly, because

18 we are going to have to make assignments and

19 I think you got a sense for some of the

20 general concerns. 

21 I actually don't think it is

22 necessarily our job to sort of re-craft these

Page 377

1 questions. I will be happy to --

2 DR. MARTIN: Of course, it isn't. 

3 To the extent you have very specific

4 suggestions, we are perfectly prepared to go

5 away and spend the time tomorrow that we would

6 have otherwise been here, since we have

7 completed this Panel's discussions much more

8 quickly, to rework these questions. I have no

9 problem going back and making them more

10 specific. 

11 I do want to leave them open-ended

12 enough to encourage broader thinking. One

13 question I have for you. Right now we have

14 framed some general questions that cut across

15 all the chapters, and then more specific

16 questions within each chapter. Otherwise, we

17 will end up repeating some of the questions

18 for each chapter --

19 CHAIRMAN SAMET: That is fine.

20 DR. MARTIN: So if you are

21 agreeable with that, we will --

22 CHAIRMAN SAMET: That is fine. 
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1 Sure.

2 DR. MARTIN: -- retain the format

3 of asking some questions that will apply

4 across the board. Questions about level of

5 detail are important, and we are only going to

6 ask it once, but we are asking it with regard

7 to each chapter, those kinds of things.

8 Then we will look to be more

9 specific in teasing out the issues about our

10 views on adequacy, indicator averaging, and

11 high-level and form for each of the three

12 chapters and try to craft more specific

13 questions.

14 CHAIRMAN SAMET: Yes, Mort?

15 DR. LIPPMANN: There is nothing

16 here about biological plausibility as could be

17 informed by the toxicological literature. 

18 Isn't that related to the policy issue?

19 DR. MARTIN: I would say that

20 falls into the issues that we would judge to

21 have been settled in the ISA. The ISA dealt

22 with those issues in reaching their causal

Page 379

1 inferences and we take those causal inferences

2 as givens here and, therefore, we are not

3 revisiting the underlying basis for those

4 judgments.

5 DR. LIPPMANN: But shouldn't there

6 be some summary of what you just said in the

7 policy document?

8 DR. MARTIN: There is a summary in

9 each chapter of what the ISA had to say about

10 the causal nature of the relationships. We

11 start the discussions with that as the

12 predicate for what follows.

13 DR. LIPPMANN: But in the

14 questions we are being asked, shouldn't we

15 comment on the adequacy of that summary for

16 this purpose?

17 DR. MARTIN: Well, that is part of

18 technical content. Did we adequately capture

19 the technical content, and if you think we

20 didn't do justice to describing the causal

21 inference, then that is a question that you

22 can speak to that point.

Page 380

1 CHAIRMAN SAMET: But I do think

2 the information on toxicology and mechanisms

3 will come both in the causal inferences and

4 considerations of uncertainty, for example,

5 and extrapolation of concentration response

6 relationships or susceptibility; I mean, some

7 of the issues that will emerge as important

8 considerations.

9 So I think it should be there in a

10 general way, even if not -- as an

11 underpinning, if not mentioned specifically.

12 Let me -- so I do think -- I think

13 we can probably -- if there are editor --

14 burning comments that you would like to make

15 or changes to these charge questions, I

16 suggest that you make them, Ed, tonight, and

17 we will give them to the EPA staff tomorrow.

18 Let's talk a little bit about

19 tomorrow and what we need to get done. So we

20 have two public commenters on visibility. We

21 have Tom. I think we need to take some time

22 and talk about our way forward with this

Page 381

1 review, and how to divide up the work because

2 there is a lot of it and this is a new kind of

3 document and I think this is a very important

4 review for the Panel.

5 So we want to talk about that and

6 I think, to the extent that we can make some

7 progress on our reviews to the risk assessment

8 and the visibility document, that that would

9 also be useful.

10 So we have our leaders for the

11 charge questions, if they could begin to

12 assemble. I don't think -- I think this is

13 probably pretty straightforward in general. 

14 There is some new text, Frank, that we sort of

15 committed to here around Chapter 5 and some

16 other things, so we will have to remember to

17 do that.

18 So that looks to me like our job

19 tomorrow. A different question is, can we

20 finish early or will we. I guess probably the

21 answer is, I don't know, and for those of you

22 eager to possibly leave early, let's see what
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1 happens.

2 So I think with that -- and I

3 don't know if -- I am certainly game to start

4 a half-hour earlier if others are, with the

5 possibility of finishing earlier. So that

6 would mean we would start at eight instead of

7 8:30. I think generally we have all been down

8 by then.

9 DR. STALLWORTH: Jon, one way we

10 could use time tomorrow, if you want to, is

11 have subgroup leaders e-mail me their

12 consensus responses tonight, and I put

13 together those two letters and we go over them

14 tomorrow. That would move things along, and

15 then on April 8th we can just address the

16 policy assessment and any finishing touches.

17 MR. POIROT: Will we have EPA

18 staff working on earlier plane reservations

19 for all of us?

20 DR. STALLWORTH: I'm optimistic I

21 can make a twelve o'clock flight, and when I

22 get there, I just go to the kiosk of American

Page 383

1 Airlines and I choose the earlier flight.

2 CHAIRMAN SAMET: Yes. I think we

3 could be done. Again, it depends on how

4 broadly we reach tomorrow. I think the

5 business we have to do, which is to hear from

6 Tom and our public commenters, I think, and

7 decide how we are going to -- I think deciding

8 how to approach the review will take some

9 discussion and designating people to take

10 leads.

11 I think this is an opportunity for

12 you to sort of step forward and say this is

13 what I want to work on, as well. So take a

14 look at the -- I would suggest that another

15 piece of homework for tonight would be to look

16 again at these charge questions and take a

17 look at the policy assessment.

18 DR. STALLWORTH: I think we can

19 commit to ending by eleven, 11:30?

20 CHAIRMAN SAMET: We can try. Yes. 

21 So let's see where we are. I mean, we are

22 certainly aiming to get done earlier to the

Page 384

1 extent possible. 

2 DR. HENDERSON: But we will have

3 lunch available?

4 DR. STALLWORTH: Yes, that is the

5 problem. If you want to stay around for

6 lunch, you can.

7 DR. HENDERSON: I do. Did you

8 settle on whether people were going to draft

9 their parts of the letter tonight and then --

10 CHAIRMAN SAMET: Well, that is

11 what Holly said.

12 DR. STALLWORTH: Is that agreeable

13 to subgroup leaders? It does help move things

14 along. It is going to be a very imperfect

15 letter tomorrow. We have struggled with this

16 in the past. We will probably continue

17 struggling with it, but if I have a first

18 draft that everybody, then, can later comment

19 on, it really saves tons of e-mail traffic and

20 we are that much further along.

21 Is that agreeable with the

22 subgroup leaders, to e-mail me a consensus

Page 385

1 response to your question tonight and if I

2 don't hear from you, I am going to use

3 whatever I have already got from you.

4 DR. FREY: Just so you recognize

5 it is a response. It might not be the fully

6 vetted, two-sentence --

7 DR. STALLWORTH: Right, and then

8 tomorrow we can talk about it, but it gives us

9 something to start with. Thank you.

10 CHAIRMAN SAMET: Okay, good. So 

11 anything else --

12 DR. STALLWORTH: I go to bed at

13 ten o'clock. So I need to start putting it

14 together at nine.

15 CHAIRMAN SAMET: Okay. So

16 anything else anyone wants to bring up? So we

17 have done a lot today. We have wandered here

18 and there but I think we have gotten the job

19 done that we needed to on these two documents.

20 I think this discussion of the

21 policy assessment was very valuable, and I

22 think we are, obviously, still probably all
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1 learning exactly what it is going to turn out

2 to be and I think, again as I said, our

3 guidance here will be important.

4 So I think we are done at five

5 after five.

6 DR. PHALEN: Jon, do you want a

7 show of hands on eight o'clock versus 8:30?

8 CHAIRMAN SAMET: Show of hands on

9 eight o'clock versus 8:30? All in favor of

10 eight o'clock? Two hands.

11 DR. HENDERSON: Eight-thirty? 

12 Five hands.

13 CHAIRMAN SAMET: You western

14 wimps.

15 DR. PHALEN: And it will save

16 time, you know, if we come mentally capable.

17 CHAIRMAN SAMET: I think, if you

18 want to try and have a stab at getting out

19 earlier, I would suggest eight. 

20 MR. POIROT: Can I just ask if we

21 know what time are the visibility commenters

22 and Tom?

Page 387

1 DR. STALLWORTH: Well, it is on

2 the schedule for 9:10 tomorrow morning, so I

3 think that is when they will call in.

4 MR. POIROT: So we would be

5 working on something else for the first part.

6 CHAIRMAN SAMET: Well, I think if

7 we had a solid block from eight to nine, that

8 would probably be useful. Come on, Sverre,

9 you can do it. Eight o'clock, voluntary?

10 DR. SUH: We can have it at eight

11 o'clock in Sverre's room. 

12 CHAIRMAN SAMET: So how about a

13 grudging eight? All right. Thanks, everyone.

14 (Whereupon, the above-entitled

15 matter went off the record at 5:06 p.m.)

16 

17

18

19

20

21

22
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attuned 285:22

audience 23:8

319:16 344:4

353:15

audio 50:8

author 12:12,14

34:6 265:15,17

authors 28:1 32:19

110:7 333:22

available 5:6 14:18

22:20 26:12,20

29:3,10,14,21

30:11 35:16 36:2

36:3,11 39:17

46:2 125:2 221:9

221:22 230:21

236:22 240:4

259:11 266:14,22

269:9,18 270:17

270:22 284:5

286:14 298:17

299:4,6 309:15,16

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Avatar 172:3

average 31:8 40:19

55:22 56:3,11

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67:9,20 71:22

72:12,13,20 73:13

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90:15 99:1 102:11

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170:12 187:20

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212:18,19 213:8

213:13,16,20,22

234:20 235:15,21

236:12 241:8

261:6,20 294:7

averages 55:20,21

87:7 166:18

234:10 235:17

241:6,14

averaging 30:10,13

30:17,18 31:9,11

31:17 35:3 38:20

40:5,6 41:2 87:14

109:3 158:17

236:4 268:4,11

327:3,6,8 378:10

avoid 45:3 291:16

Avol 2:2 6:8,8

110:2 172:6

173:18 175:16

176:15 198:18

256:5 370:10

aware 35:18 36:5

219:14 291:6

awful 156:16

304:11 312:6

axis 166:17 238:10

a.m 1:14 4:2

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B

b 85:12 87:5 108:17

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back 36:16,17 40:7

49:12,20 51:5

56:1 75:1 85:9

86:9 108:18 114:2

114:15 117:19

118:2 123:21

129:22 130:14

135:14,18 143:4,6

170:9,17 173:13

177:2 179:12

187:2 199:5,11

200:1 203:18

205:4 226:21

232:8 243:2

247:13 259:16

260:16 290:14

294:19 301:14

312:10 317:16

318:3 319:6 321:3

321:5,9,22 323:1

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334:21 339:9

343:15 351:10

364:3 369:18

373:14,18 377:9

background 23:15

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223:21 240:22

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Background/Sch...

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backwards 177:21

bad 49:13 50:12

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bait 217:3

balance 41:17

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bar 296:8 299:20

base 35:21 80:10

93:22 122:22

126:1 141:20

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308:2 340:8

based 14:17 17:8

18:17 29:4 32:15

79:19 82:8,10

84:3 99:2 121:17

123:4 127:6 131:2

131:16 132:10,21

140:14 163:8

174:22 179:4,5

182:12,15,21,21

186:2 192:3,3,7

192:12,21 201:18

227:11 228:22

235:12 236:21

240:2,2 257:17

294:4 296:4

298:20 299:5

307:7 308:1 327:2

327:13 329:9

345:19 350:13

354:22

baseline 105:4

116:6,13 134:4,15

135:3 177:15

178:12 197:7

198:4 207:11,11

216:8 342:3

basic 44:22 149:11

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basically 38:4 65:3

76:10 95:9 108:22

123:8 153:22

155:6 157:3,18,21

162:10 163:12

174:17 182:11

183:1 215:4

271:21 274:16,21

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309:15 310:8

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basin 104:19,21

174:7 175:20

basing 217:1

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basis 13:3,14 15:7

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78:8 119:10

122:12 137:4

172:22 181:5

183:5 194:1 225:8

242:8 247:4 255:7

276:16 282:8

283:18 289:15

329:9,14 345:13

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bat 167:13

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bearing 213:17

bed 385:12

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Bell's 133:8

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best 16:19 77:14

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Beth 12:10 25:5,17

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big 22:3 24:9 73:10

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Bill 294:18 301:13

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biological 378:16

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Birmingham

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Birth 117:1

bit 47:14,18 127:9

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blah 334:16

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blaming 250:9

blank 252:1,1,13

blend 279:11

block 387:7

blood 315:15

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BMI 315:15

board 2:18 378:4

Bob 7:5 49:5,11

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123:5 246:10

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body 277:6,9 280:5

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bookending 160:16

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border 162:19,20

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broad 68:18 123:10

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broader 58:5,9

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broken 38:18,19

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budgets 304:3

build 48:16,17

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building 199:1

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builds 332:2

built 371:1

bulk 156:19

bullet 55:14 56:12

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bulleted 66:6

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bunch 79:2

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calculating 187:22

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calculation 112:3

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calculations 193:13

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calibration 295:7

California 6:3,9,11

6:19 7:6 372:20

call 26:15,21

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called 46:7 101:11

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calling 50:7 90:6

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Canada 36:6

cancer 78:3 125:3

cap 272:20

capable 386:16

Capitol 285:6

capture 92:1

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captured 196:6

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capturing 195:17

carbon 270:5,6

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cardiac 314:3

cardiopulmonary

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categories 178:5

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causal 40:14 77:8

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caused 122:9

causes 119:14,15

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caveats 95:12

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CD 79:12

cell 182:12,21

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centers 79:21 160:1

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certain 63:6 83:6

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certainly 17:6 64:1

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166:15 173:8

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185:1,14 189:3

207:3 216:6,21

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383:22

certainties 218:7

certainty 129:18

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Chairman 1:14,18

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81:6,9,13 85:4,14

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101:4 106:22

108:6,16 109:6

113:19 115:2

117:9,12 119:21

123:5,12 127:16

128:21 131:22

135:11,18 136:5

145:20 147:9,17

149:7 154:4

155:21 156:13

168:15 169:12,16

169:20 172:2,5

176:22 180:15

182:2,8 184:3

185:16 186:9

187:4,17 191:18

193:11 198:17

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239:6 242:22

244:11 245:11,13

245:17,20 248:18

249:7 250:18

253:14 255:4,10

261:13 262:20

263:15 264:1,4,16

275:12 276:9,20

278:11 279:13

280:18 283:12

284:10 285:16

286:5,20 287:5

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challenge 246:8

challenges 126:14

challenging 117:5

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chance 10:2 49:12

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characterization

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62:6 75:13 80:19

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295:20,21 307:3

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320:18 321:6,21

323:3,21 324:2,7

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334:9,12,21 336:6

339:13 342:19

350:20 351:3

359:2 362:17,20

363:3,6,12 364:9

364:12 370:3

374:17,21,21

380:15 381:11

383:16

charged 110:3

339:21

charges 58:15

charter 317:13

chase 280:3

cheesy 100:3

chemical 149:3

chemistry 301:21

Children's 372:19

372:20

chime 205:9

choice 130:6 202:4

202:5 237:1 259:2

choices 109:16

110:8 151:9

341:11

choose 241:16

287:14 383:1

chooses 223:3

choosing 349:5

chopping 89:8

chose 114:21

371:17

Chris 6:4 145:21

148:5 149:7 154:5

280:20 319:15

353:2

CHRISTOPHER

1:20

chunk 185:12

cigarette 246:20

circulating 338:22

circumstances

239:1

cite 220:20 237:3

354:13

cities 84:16 87:2

100:11 119:9,10

124:19,22 125:18

128:2 154:13

158:16 160:17

165:12 169:3

171:16 172:20

177:21 181:5,7

186:2 189:9,17,18

195:13,16,18

196:7,18 197:18

197:19 199:3,8

201:20 207:12

214:22 215:4,11

216:2,19 218:11

218:16,17,22

219:3 234:8,16

241:6 257:4,6,8

259:1,12,18 261:4

261:5 273:6,12,13

274:12 277:8

281:9 282:15

367:11 368:4

372:16

city 72:18,18 73:3

82:11,15,20 94:21

100:15 111:1,3,11

111:14 114:10

128:12 155:8

161:21 162:4

164:12 173:6,10

173:17,19 174:17

184:8 187:20

259:3 303:22

319:11 332:11

367:11,11

clarification 56:17

90:3 155:1

clarified 59:19

109:14 166:12

181:20

clarifies 91:7 184:1

clarify 155:19

163:5 166:11

177:8 179:10

184:7 185:14

188:22 222:5

230:9 372:4

clarifying 44:6

75:14 110:7

218:12 357:8

clarity 104:17

148:20 218:15

281:13 366:2

Clarkson 7:9

class 112:12,12

classification

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classified 78:5

classify 61:14

clauses 217:21

clean 1:3 4:8,14

48:4 122:5 123:13

123:17 292:3

317:8

cleaned 365:3

clear 56:13 63:19

79:3 82:19 84:2

90:10 92:14,15,19

94:3 109:1,19

118:4 130:14

134:19 136:17

140:8 141:3 151:2

163:4 164:21

171:7 172:18

173:14 176:19

177:6 182:13

183:9 185:1,14

197:3 215:8 218:6

218:8 224:16

230:22 253:5

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climate 138:1

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clipped 91:4

close 211:8 314:1

closely 353:11,13

closer 50:13 124:18

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closure 305:15

clue 331:18

CMAQ 182:21

191:22 197:11

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CNO 333:17,17

coarse 12:9 34:8,15

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39:3,7,12,21 40:2

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44:13 45:3,9

47:21 53:11

206:18 268:10

304:10 305:6

306:4,6 307:8,10

307:15 309:4

312:20 314:18

348:12 356:7,15

357:19 358:3

coast 43:14,15

74:13

coastal 305:13

306:1

code 340:22

coefficient 112:22

367:14

coefficients 236:8

259:17 282:14

367:13 368:15

coherent 354:10

cohort 76:2 82:5

112:7,10 113:4,5

124:18 125:12

129:2,4,6,12

131:4 367:21

cohorts 126:6

368:1

cold 52:7

colleagues 172:7

collected 267:4

collecting 140:7

College 7:12

colorful 274:11

column 153:9

293:17

combination 71:9

combinations

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combine 90:9

300:8

combined 198:15

309:17

combines 198:6

combining 281:8

come 47:13 49:12

49:20 51:3 95:21

101:16 114:1

123:21 129:21

142:16,19 144:1

175:6 181:10

187:5 198:7 217:8

225:18 231:5,7

233:3 240:21

321:2,5,9,22

323:1 326:5

332:12,19 338:9

339:9 343:6 365:1

367:6 373:14

380:3 386:16

387:8

comes 8:7 13:22

82:8 105:1 216:5

216:12 228:15

229:18,21 257:6

258:12 261:17

296:21 311:2

312:4,16 331:9

352:22

comfortable 88:6

238:21

coming 7:18 9:18

166:8 171:17

177:2 193:7

205:15 206:3

220:1 259:8

283:20 300:22

321:18 344:9

367:3

commend 110:6

comment 5:7,9

45:19 86:15 87:10

97:9 100:9 130:4

137:9 138:5 139:8

140:15 143:10

144:6 148:7,11

150:2 151:12,21

153:5 172:1,9,15

173:21 180:8

185:17 201:2

206:16 231:5

246:11 247:14

250:17 261:15

264:7 276:12

280:7 283:13

287:7,15 293:22

301:17 305:1

336:6 344:17

353:2 362:14

365:13 368:14,19

369:1,17 370:11

371:17 372:4

375:7,8 379:15

384:18

commented 205:8

239:22 285:17

301:14

commenter 75:19

80:16 85:5 237:10

264:17

commenters 85:8

276:10 320:13

380:20 383:6

386:21

commenting 76:6

330:21 375:17

comments 3:9 8:21

11:21 20:11,16

26:1 50:22 51:4

51:14 68:8 75:18

76:12 81:3,18

83:17 86:8 96:8

96:22 97:7 103:5

108:16 109:21

110:13 114:8,11

115:6 117:15

120:3 123:7,11

130:2 131:18

133:5 136:2,22

137:1,10 138:6,7

138:19,20 139:4

141:6 144:14

145:16,19,22

146:1 147:10

148:4 149:16

151:14 154:2,3

155:21 156:14,16

158:5 169:13,19

169:21 172:7

173:12 177:2

180:16 189:5

190:12 199:12

206:6 208:19

223:9 224:19

249:19 250:1

255:14,16 264:22

272:5 276:3,5,7

277:2 278:12

279:15 280:20

281:20 288:9

291:8 293:15

294:17 307:4

308:8 312:12,14

312:21 316:19

318:5 321:5 322:7

323:16 338:19

339:1,19,20 363:9

363:10,13 364:2

374:17 375:12

380:14

commiserating

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commitments 9:13

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committee 1:3 4:12

4:14,15 6:1 8:10

83:17 136:1 158:2

321:2 344:16

360:9

Committee's 21:10

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communicate

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communicated

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communicates

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communicating

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communication

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communities 113:7

113:8 126:4 200:9

202:10

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compare 55:20

56:2,6 65:16

97:20 151:22

298:15 299:10

303:10

compared 54:10,17

56:21 64:14,22

102:9 146:12

151:6 175:19

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comparisons 87:6

compelling 248:14

competent 260:20

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complain 220:14

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complete 200:17

completed 10:12

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completely 115:15

133:14 172:17

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completeness

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complex 149:19

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complexities 48:13

complexity 48:16

278:17

compliance 103:15

165:6,10,13 215:4

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complicate 155:10

complicated 114:6

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complying 223:22

component 30:1,5

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components 29:19

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composite 55:20,21

56:2,11 57:1 59:6

87:6 99:1 164:16

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compositing 87:13

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composition 197:7

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compositional

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comprising 109:16

110:9

compromise 315:5

concentrated

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concentration

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132:12 133:20

134:20 138:21

142:12 151:17

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232:12 233:18

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concentrations

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37:8,9 39:7,8,10

39:12,21 40:20

41:17 45:10 83:14

84:5,9,12 137:12

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236:3 262:3

306:19 361:11

concentration-re...

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concept 145:14

192:16 256:8

conceptual 315:7

conceptually 99:17

135:9

concern 68:19,20

74:18 78:14 98:17

127:4 133:11

142:1 184:10

185:18 186:10

205:17 207:7,8

219:7 226:16

286:13

concerned 133:5

180:10 181:15,18

186:6 226:13

304:8 340:1 351:6

375:22 376:1

concerns 68:10

76:11 113:15

141:2 300:6

328:20 329:22

374:19 376:20

concise 279:8

conclude 18:18

77:2

concluded 40:13

76:15 80:8

concludes 85:3

conclusion 80:5

188:12 219:7

229:9 261:9

309:15 327:17,19

343:6 352:12

359:7,15,16

360:19 361:3,19

361:21 362:7

conclusions 17:5

17:12,20,22 18:8

18:11,16 22:8

33:18 38:15 40:8

40:9 142:1 155:7

218:9 222:19

273:19 326:9,16

327:1 344:6 345:8

345:10 348:8,16

350:6,14 358:22

360:7,8,10 361:15

conclusively

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condition 301:11

conditional 145:1

145:12

conditioning

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conditions 183:9

183:12 267:10,19

293:1 296:2,15

conduced 63:12

conduct 31:14 32:2

105:13 106:2

conducted 4:19 5:1

33:1 36:7 37:21

64:4,9 94:17,17

146:13 164:14

176:20 182:20

230:12 272:6

conducting 53:9

59:2 164:11 173:5

conference 264:15

372:2

confess 237:14

confidence 28:10

53:16,18 54:12

57:9,14 63:18,19

68:21 74:6 75:6

83:21 84:3 151:16

151:19,22 152:9

209:16,19,20

228:22 230:17

231:14 233:12

240:6 242:16

243:8,10 245:1

246:5

confident 166:22

confirmed 82:19

confirming 83:11

conflict 5:14

confounding 36:9

77:11 78:16 79:5

79:9

confused 93:16

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confusing 91:13

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154:15 160:5

confusion 90:7

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congratulations

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Congress 122:4,22

226:18

Congressional

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conjunction 31:6

31:21 196:12

consensus 21:11

140:14,19 141:14

382:12 384:22

consequence 39:5

260:3

consequences

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conservative

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consider 10:2 11:6

14:16 16:1 24:1

46:16 57:21 99:15

109:19 121:16

122:11,21 136:16

142:17 155:12

164:1 176:4 214:6

216:8 224:22

225:12 253:3

267:21 273:1

299:3 343:12

371:11 373:10

considerably 308:5

consideration 13:7

13:17 14:1 15:15

17:9 18:1 21:21

33:5 37:16 39:16

47:8,20 52:20

54:7,21 57:7

60:14 77:7 122:3

149:14 158:3

269:21 270:3

288:17 293:6

349:14 369:7

considerations

32:8,11,15 35:21

38:13 41:13,14

122:3 238:5 252:9

252:10 277:20

302:19 327:14

340:8 341:19

342:7 360:18

364:21 380:4,8

considered 22:1

30:7 31:19 55:5

57:10 63:5 77:17
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conspicuous

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CONTENTS 3:1

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120:9 126:5 148:1

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continue 17:7

24:17,21 30:12

31:16 49:14 232:3

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continuing 45:21

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contrasted 54:11

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contribute 280:17

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contribution 244:7

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contributions

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controlling 94:20

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controls 96:16,18

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conundrum 237:18

Convene 3:2

convened 1:13

convenience 125:1

193:16 235:20

converged 289:12

convergence 289:7

conversation 43:19

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Conversely 72:7

convey 106:5

354:19

convinced 229:7

299:15

convincing 131:7

COPD 135:4

copy 85:16 136:2

310:6 346:13

copying 350:8

core 53:12,14 57:9

59:14,15 60:15

62:22 63:20 69:12

110:9 142:16

144:2,9 146:11,19

146:20 149:15

152:4,10 153:16

Corrales 50:11,16

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correct 5:10 44:14

44:21 125:16

133:13 183:14

194:13 238:17

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corrected 113:18

124:8 177:17

293:20 294:11

correction 111:22

112:19 129:16

correlate 39:11

correlated 67:1

284:20

correspond 111:6

corresponds

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cost 15:1 118:12

122:21 123:2

couched 142:20

count 315:7

counter 165:22

167:12

counterpoint

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counter-factual

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counties 111:5

113:21 134:2,11

174:17 178:1

215:18,19,20,22

216:2,2,11

country 157:13

160:2 168:20

181:8,13,14,17

185:7,8 189:11

190:8 219:5

227:12 241:8,12

county 111:5,7,8,8

111:10,20 198:3

couple 40:21 81:18

94:7 101:5 144:13

157:20 158:8

161:18 174:9

181:9 214:17

252:19 257:15

277:18 297:21

305:12 322:12

course 21:13 39:3

68:13 120:17

124:17 196:10

226:16 231:13

242:21 292:11

339:2,12 345:18

358:5 377:2

court 23:1,3,11

courts 122:6

cover 25:2 44:8

82:6 202:22

coverage 59:22

135:10

covered 149:18

252:5 262:21

271:13

covers 60:9 153:22

co-pollutant 37:20

co-pollutants 79:9

co-variability

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CR 76:21 77:10

78:9 79:20 109:18

114:17 127:6

131:21 152:10

201:18 211:20

254:18

craft 378:12

crank 246:14

crazy 205:10

create 15:18 19:15

277:13 322:7

329:17 345:17

350:5 354:18

355:6

creating 345:2

credibility 219:21

credible 237:3

242:18 260:10

368:9

credit 260:19

criteria 115:11

233:3 238:4,6,8

239:3,4 244:8

341:21

critical 60:4 98:18

105:15 314:18

330:16,19 370:9

criticism 175:14

186:11,19 226:18

criticisms 221:4

critique 365:8

critiquing 282:9

crossed 244:17

276:18

cross-section 126:3

crude 129:10

cubed 183:19

cubic 222:11

246:15,15

curious 115:5

146:6 220:21

325:8

current 13:4,15

24:8 26:10,16

27:17 28:9 31:22

33:20 34:14 35:7

35:14 37:10,11

38:9 70:14 77:1

80:7,12 83:10

87:12,22 90:13

183:13 185:4
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C-o-r-r-a-l-e-s

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daily 71:16,20

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Dallas 71:13,18

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damage 271:10

dangerous 98:13

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dark 72:9

Dartmouth 7:11

data 32:16 36:22

46:2,5,18 78:11

97:17,18 98:21

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134:6,18 140:7

143:17 157:4,7

159:11 160:10

174:16 192:4

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212:11 219:11

233:10 259:4,11

267:3 273:11

282:4,5,9,11

286:14 303:6

304:11,12,15,16

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database 97:10

databases 198:3

dataset 127:8

Dave 265:1 276:20

279:17 286:9

David 2:5 6:18

75:19

David's 288:13

Davis 6:11

dawn 301:9

dawned 171:12

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235:16,16 246:15

267:7 273:2,6,15

298:22 299:4,7,18

299:20 300:13,15

302:15,16 336:8

daylight 273:2,17

274:3,3,5,8 275:6

293:18 296:3,11

298:17,21 299:6

299:22 300:7

301:6 304:5

days 225:18 296:9

298:15 304:4,10

deal 34:13 49:18

117:3 150:18

229:19 259:21

285:7 316:6

367:22 369:22

dealing 97:10

123:17 156:14

167:7 207:18

230:8 236:11,16

deals 10:4 149:10

236:18

dealt 35:6 208:5

218:3 325:9

378:21

death 83:13 119:13

119:15

deaths 82:7

Debbie 81:2,8,10

85:5

decades 224:2

decaying 105:4

decide 232:11

245:8 333:1

350:13 367:19

383:7

decided 341:8

deciding 18:5

164:19 383:7

decision 14:20

31:10 62:20 100:6

118:10,22 119:2

219:1 325:20

328:17 343:2,20

345:1 346:14

355:1

decisions 15:9

18:13,22 20:12

22:20 23:1,2,4,5

24:5 36:12 38:9

192:2 225:6,8,15

225:16 237:4

328:15,16 348:13

371:7

defend 19:1,1

225:8 280:6

defended 117:17

defending 19:2

defense 16:19

defensible 171:7

260:11 286:19

defensive 257:4

259:2 260:11

deficiency 113:1

define 77:10

defined 49:3 116:7

153:14 158:21

159:2,4

defining 94:4

definitely 49:11

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318:12

definition 48:18

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degradation

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71:6 75:6 90:15

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deleting 276:2

deliberating

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deliberations 4:18

4:21

delta 211:17

213:19

deltas 180:3,11

214:8 233:11

demanding 247:4

demographics

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218:18

demonstrated

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demonstration

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denominators

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dense 217:18

departs 194:4

depend 42:7,15

45:12

dependencies

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dependent 170:13

depending 133:19

178:2 359:7

depends 337:6

383:3

deposited 246:18

deposition 48:14

246:19 247:5

depositional

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deposits 246:21

depressing 105:4

derivable 13:2

derive 25:9

derived 284:19

describe 115:19

135:9 187:12

described 95:22

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describing 346:19

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description 209:5,6

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descriptions

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descriptive 332:20

descriptors 243:14

deserve 260:18

deserves 38:22

deserving 18:6

design 57:22 58:1,3

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diet 125:4

differ 56:7,8

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138:22 147:5,6

151:3 152:2,11

158:17 160:17

161:17 164:8,9,12

164:14 168:20

174:8 177:12,16

178:5,21 180:4

191:4 192:22

193:1,7 196:14

197:20,21,21

198:4,5 208:1,1

212:8,21 218:21

234:2 235:9

238:10 240:22

251:11 254:17

259:18 268:4,16

268:20 272:2,17

273:6 275:8

276:14 278:2

282:15 283:2,3,7

285:14 286:18

289:8,9 290:19

292:13 303:9

318:11 319:16

326:10 329:6

335:13 342:6

343:13 344:7

345:2 353:11

359:8 361:2 368:9

373:9 381:19

differential 227:20

differentiation

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differently 27:3

176:21 178:1

356:16

differing 48:13,21

difficult 225:10

248:6 314:19

difficulty 307:22

digest 160:13

dimension 161:20

162:6,6 171:14

diminishing 289:18

direct 118:10

269:22 314:9

directed 194:19

direction 101:11

114:1 133:3

146:10,11 198:22

directionality

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directions 100:1

146:17

directive 47:3

directly 13:18 24:2

119:22 242:3

244:22 288:4

308:20

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202:10 205:20

210:17 211:16,22

215:12 216:4,10

219:8 221:6,10

222:16,19 223:18

224:17 230:6,12

230:20 231:2

239:18 242:12,14

243:8 244:16

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249:13,16,20

250:6 251:3,7

253:4,9,10,12,12

263:7 264:3

295:15 310:22

320:7 327:18

331:10,16 332:21

341:8,9,13,17

342:1,11,14

352:11 356:1,9,10

371:4 372:10,13

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risks 28:8 33:8

35:19 70:11,11

81:22 89:16 93:13

119:1,3 195:13,16

242:17 248:9

254:20,21 260:2,5

345:4 373:14,15

risk-based 26:13

28:4 32:8,11 33:5

33:21 327:14

332:1 340:8

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risk-benefit 68:5

Riverdale 305:10

Riverside 6:19

road 368:12

ROBERT 2:11

robust 76:17 97:17

robustness 283:8

Rogene 2:7 6:14

49:6 169:20

237:10 239:21

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Rogene's 247:13

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role 28:12 63:10

157:11 262:13

268:9

roles 24:11 33:14

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roll 170:9,17

rollback 55:4,6,18

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63:11,13,13 94:22

95:2 100:17 106:2

108:9 154:11

161:3 164:11,15

170:5 171:9

174:21 176:21

207:4 251:10

267:19

rollbacks 56:20

160:4,9 174:21

176:8 201:14

rolled 56:1 277:15

room 85:2 297:22

334:1 387:11

roughly 135:13

216:1 236:7

round 5:22 147:13

149:2 223:14

224:6 259:21

row 7:15 71:11

134:8,14

rubber 368:11

rubric 111:13

ruins 300:12

rule 11:13,14

240:19 243:2

246:4 247:19

272:21

ruled 77:16

rulemaking 11:12

353:10,21 354:18

354:19

run 55:17 69:21

70:11 82:1 163:14

221:8 230:19

running 230:17

runs 230:14

rural 39:13,22

Russell 1:21 6:16

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85:15 101:2

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rut 46:20

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safety 15:20 229:14

245:16,19 325:8

325:12,16 326:1

328:8,11 329:17

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Salon 1:13

salt 72:18,18 73:3

305:13,19 306:1

Samet 1:14,18 5:17

5:18 6:2 7:13

16:17 43:4 44:1

45:15 46:6,21

47:15 49:4 51:1

75:11,21 80:15

81:4,6,9,13 85:4

85:14 88:18 95:19

100:8 101:4

106:22 108:6,16

109:6 113:19

115:2 117:9,12

119:21 123:5,12

127:16 128:21

131:22 135:11,18

136:5 145:20

147:9,17 149:7

154:4 155:21

156:13 168:15

169:12,16,20

172:2,5 176:22

180:15 182:2,8

184:3 185:16

186:9 187:4,17

191:18 193:11

198:17 199:10,22

202:1,18 203:1,6

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208:20 217:11

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scatter 65:18

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scenario 70:12 95:7

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372:6 374:6

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scientist 244:7

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season 120:22

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241:7 248:22

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306:20 310:6

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September 25:21

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seriously 336:13

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served 195:11

serves 195:10

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58:5,9 62:11

65:14 66:16 94:18

96:4 98:3 116:15

119:22 150:5,17

192:2,11,21 193:1

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233:3 236:21

243:5 245:4 313:6

337:16 340:13

344:6,18 345:1

351:15 352:6,13

sets 53:19 157:18

259:4 272:17

setting 14:9,10 15:9

44:10 48:4 89:6

120:5 121:21

125:17 193:4

194:15 227:2

228:19 249:21

255:7 306:2,11

325:16,22 329:22

settle 384:8

settled 378:21

set-up 344:22

seven 67:10 214:1

233:7

shades 329:4

share 96:8 137:1

186:10 345:8

sharp 329:12 340:3

344:1

sharpen 168:5

323:15 330:5

365:15 370:5

sharpened 361:15

362:22 363:16

sharpening 351:9

374:3

sharper 321:10

338:8 361:19

363:6

sharply 329:12

shave 89:19,20

shaving 54:21 55:9

55:16,18 56:3,20

59:5,11 60:3

63:12 85:21 89:4

90:6,11 92:9

94:11 95:4 96:20

100:17 101:12,14

101:20 102:12,20

103:7 104:6,18

105:8,17 106:8

107:7 108:11

154:11 161:3

201:12

shed 329:10

sheep 107:2

shift 101:15 212:2

212:5 213:1,4

214:6,7 284:14

285:20

shifted 91:5 101:18

shocked 246:13

shore 262:18

short 21:4 28:7

32:12 33:7 40:12

40:15,16 41:14

56:21 66:18 67:3

78:21 84:5 109:14

134:9 177:18

178:6 210:16

211:3,14 212:4,10

271:19 276:6

339:12

shortened 221:15

shorter 218:1

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shortest 284:16

shortly 309:21

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showing 108:13

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shown 192:6

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sight 292:13,17

sign 187:2 256:21

significant 37:6

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118:12 127:14

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285:8 307:9

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significantly 368:1

silence 317:22

silly 232:16

similar 34:9 93:1

137:6 169:2,22

272:20 283:6

similarities 296:13

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Similarly 277:12

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97:11 112:20

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sites 207:9 208:9

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sitting 7:14 213:16

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situation 171:20

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situations 190:18

six 82:11,15,20

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126:3 128:2,11

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size 29:16 99:3

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Skill 52:22

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skipping 166:16

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slides 263:18 266:5

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slightly 146:14

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slowing 365:11

small 24:9 149:21

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smaller 132:15

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smart 292:6 295:12

smidgen 163:13

Smith 265:2

sneak 222:12

sniffling 52:8

snippets 213:21

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snow 291:3

socioeconomic

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soil 271:10

soils 270:18

solicit 344:10

solid 57:13 387:7

somebody 107:2

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24:11 25:2 44:10

44:16 45:9 46:19

47:12 52:4 53:2

55:6,21 60:8

61:14 72:16 74:22

83:7 86:6 88:9

93:7 100:2,9,12

100:16 101:5

105:13,14 106:15

115:19 126:21

128:3,18 129:8,10

129:16 140:14,17

145:7 147:18

156:14 159:16

160:16 166:1

167:20 168:1

169:7,9 172:16

176:15 184:17,17

184:19 186:4,16

187:1,2 193:4,16

194:14,16,20

200:9 206:7 210:8

213:1 216:15

217:1,20 218:8,14

219:19 229:6,11

232:15 233:1,20

239:15 241:12

243:2 244:1,18

250:19 251:11

256:16 257:3,6,10

257:14 261:8

274:16 282:13

286:7,8 301:17

311:2,3,16 316:3

316:9 320:21

321:21 323:4

330:22 331:10,13

332:18,19,21

335:13 336:6

340:12,22 343:17

347:15,16,19

351:19 353:5

358:1 362:5 366:4

366:19 367:15

371:1,2 376:22

381:14 383:12

sorts 307:15

sound 50:11

sounded 349:9

sounding 232:16

sounds 107:2

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source 30:1 60:4

80:2 147:4 151:4

152:5 170:14

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sources 29:19 30:5

59:22 92:17 94:15

103:13 105:2

131:20 137:5,7

139:17,20 142:11

144:4 270:21

301:22

Southern 6:2,9

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so-and-so 369:6

space 341:19

sparsity 283:21

spatial 31:8,11,16

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162:6

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134:8 266:5,6

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337:7,13,17 338:1

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29:10 30:18,19

40:17,18 60:5

77:5 120:15

121:14 132:11

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380:11

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177:1 178:8,17

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spend 22:22 69:9

323:12 377:5

spillover 107:19

split 98:3

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spoken 110:14

spread 183:19

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squishing 92:21
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121:21 122:12,19

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159:18,18 163:6

165:7,9,11,13,17

166:4,5,9 167:14

185:6,11 189:7

209:6,7 225:6,22

227:2 234:3,7,12

234:15,18 235:5

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261:22 265:9

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290:19 291:15

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308:21 311:12

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329:2,9 343:10

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2.5.1 364:13

2.5.2 364:13

2:15 252:16

2:30 204:1

20 46:5 184:15

246:16,19 343:7

20.3 285:2

2000 317:17

2004 131:3 372:22

2005 80:6

2006 23:2 31:10

372:16

2007 372:18

2008 82:21 118:17

2009 82:9 126:15

181:19 372:14

2010 1:10 263:20

21 157:20 220:16

216 281:10 282:6

23 179:19 282:7

231 283:21

239 332:9

24 28:12 30:19

57:22 63:7 72:5

75:8 234:6

24-hour 24:13

30:14 31:18,20

33:14 34:16 35:14

40:6,19 41:2

57:20 61:2,18

65:8,8,13 66:10

66:11 67:6,18

70:15,19,21 72:3

72:21 73:1,5,9

74:7 94:20 154:13

159:18 161:1,3,15

162:1 165:6,7

166:2,4 206:22

234:11,15,20

235:5 327:5

25 3:8 67:19 70:19

70:21,22 71:17

73:6 74:8 90:20

250-some 65:14

256 65:15

266 3:12

271 3:13

275 3:15

29.4 285:2

3

3 12:8,14 34:2,7,11

36:14 38:3,19

41:7 42:19 59:1

65:6 127:18

129:22 135:20

136:14 142:15

144:14 147:10

148:5,12 159:4

192:2 210:15

288:10 289:21,22

294:15 324:17

326:4 332:4 340:5

357:9

3a 340:5

3-12 296:8

3-13 296:11

3-26 306:3

3.4.4 303:18

3.4.5 303:19

3.5.3 148:13

3:30 320:6

3:31 323:9

30 101:22 102:3,7

134:14

30-some 216:1,2

311 133:6

324 3:18

34 72:10

35 90:22

353 133:10

356 144:15

363 139:15

37th 300:15

377 148:13

387 3:22

4

4 3:2 57:16 60:10

65:20 148:5,9

150:3 151:19

155:22 156:9

222:2,4 266:7

295:18 307:4

308:8 311:16

324:17 326:4

332:4

4a 179:15

4b 351:19,20

4-1 296:20

4-17 157:19

4-2 296:19

4-20 157:20

4-3 296:20

4-5 3:12 296:19

4-7 296:19

4.1 151:18 177:4

4.1.3 277:20

4.1.4 278:4

4.2 151:19

4.3 149:19

4.4 153:7

4.7 179:14

4:02 323:10

40 180:1

42 91:1

445 156:3,3

447 156:3

45 204:3 335:12

46 156:4,5,6

47 156:5,5,5,6,6

4700 1:13

48 156:5,6

5

5 3:4 157:1,3

180:16,19 182:4

193:6 194:8 200:7

202:8 203:15

265:17 269:6

270:13 311:16

324:21 326:4

332:4 381:15

5.4 200:1,22 202:3

202:14

5.5 199:13

5.7 73:13

5.8 73:16 82:15

181:19 183:16

185:7 187:16,21

5:06 387:15

50 119:12,14 180:1

284:14 285:14

50th 289:10

500 369:19

52-4 168:19

53 113:9

6

6 52:17 57:12 61:20

62:4 66:6 130:5

142:15 143:8

150:3 181:10

182:1 186:13

200:2 202:15

203:12,20 204:4

205:5 255:15

261:10 262:21

311:1

6a-e 205:6

6.5 210:15
202-234-4433

Neal R. Gross & Co., Inc.

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618 220:15

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7 249:5

7:00 322:22

70 287:11

75 3:9

8

8 364:12

8th 11:4 382:15

8:30 1:14 4:2 382:7

386:7,9

80 246:17,19 247:6

85 3:10 335:12

88,000 184:12

185:2,13 190:3

9

9 3:5

9b 359:3

9th 11:4

9:10 387:2

90 272:22 273:3

275:2 290:12,22

292:15,16 294:20

295:10 298:7

310:12

90th 273:22 296:6

299:1,21 300:9

95 272:19 295:2,5

95th 273:22 296:6

299:1,21

98 31:22 41:16 61:7

71:20 72:21 90:14

101:21

98th 273:21 275:7

296:5