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U . S . ENVIRONMENTAL PROTECTION AGENCY SCIENCE ADVISORY BOARD STAFF OFFICE CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE (CASAC ) PARTICULATE MATTER REVIEW PANEL PUBLIC MEETING Marriott at Research Triangle Park 4700 Guardian Drive , Durham, North Carolina

Monday, July 26 , 2010 ATTENDEES : CASAC Members : Dr . Jonathan M . Samet , Chair Dr . Joseph D . Brain Dr . H . Christopher Frey Dr . Armistead ( Ted) Russell Dr . Helen Suh Dr . Kathleen Weathers Consultants : Dr . Lowell Ashbaugh Prof . Ed Avol Dr . Wayne Cascio Dr . Joseph Helble Dr . Rogene Henderson Dr . Philip Hopke Dr . Morton Lippmann Dr . William Malm Mr . Charles Thomas (Tom) Moore , Jr . Dr . Kent Pinkerton Mr . Richard L . Poirot Dr . Frank Speizer ( Telephonically present ) Dr . Sverre Vedal Science Advisory Board Staff : Dr . Holly Stallworth Dr . Vanessa Vu Office of Air Quality and Planning Standards Ms . Lydia Wegman Ms . Vicki Sandiford Dr . Karen Martin Dr . Marc Pitchford Ms . Beth Hassett-Sipple Mr . Tim Hanley Dr . Scott Jenkins Ms . Joann Rice Dr . Pradeep Rajan1

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I N D E X Page Proceedings 3 Welcome and Opening Remarks by : Dr . Stallworth 3 Dr . Vu 5 Dr . Samet 7 Ms . Lydia Wegman 11 Dr . Karen Martin 13
Public Comment Statements By : Dr . Jay Turim, on behalf of American Chemistry 24 Council Ms . Deborah Shprentz , on behalf of the American 30 Lung Association Mr . Ben Brandes , Air Quality, National Mining 34 Association Mr . Greg Schaefer , Arch Coal , Inc . 38 Mr . Wig Zamore , Somerville Transportation Equity 41 Partnership and Mystic View Task Force , Somerville , Massachusetts Dr . Julie Goodman , on behalf of American 45 Petroleum Institute Mr . Jon Heuss , (Telephonically present ) , Air 49 Improvement Resources , Inc . Dr . John Richards , Air Quality Control Techniques 54 on behalf of Particulate Matter Coalition Dr . Deborah Drechsler , (Telephonically present ) , 59 California Air Resources Board
Discussion re : Charge Question No . 1 62 Charge Question No . 2 66 Charge Question No . 3 80 Charge Question No . 4 144 Charge Question No . 5 160 Charge Question No . 6 168 Charge Question No . 7 187 Charge Question No . 8 209 Charge Question No . 9 214 Charge Question No . 10 2271

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P R O C E E D I N G S ( 9 : 00 a . m . ) OPENING REMARKS BY DR . STALLWORTH :

DR . STALLWORTH : Good morning, everyone . I ' m Holly Stallworth . I ' m the Designated Federal Officer for the Clean Air Scientific Advisory Committee Particulate Matter Review Panel ; and if you could bear with me , I just want to remind our audience of
our requirements under the Federal Advisory Committee Act . CASAC is a Federal Advisory Committee ; and by EPA policy, its meetings and deliberations are held
as public meetings that meet the requirements of FACA . CASAC is empowered by law to provide advice to the Administrator consistent with the requirements of FACA and with EPA policy . CASAC ' s deliberations are conducted in public at meetings for which advance public notice is given . The discussions and substantive deliberations of the Panel , its interactions with the public and the Agency are conducted in sessions where I as the Designated Federal Officer am present to ensure that the requirements of FACA are met . These include requirements for open meetings , for maintaining records of deliberations , making available public1

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summaries of meetings and providing opportunities for public commenting .

Today we do have eight public commentors . We have a list of six, and two more requests came in after that list was photocopied .

I ' ll be taking the minutes of this meeting to summarize the discussion and action items . Once they ' re approved by our Chair, Dr . John Samet , they will be posted on the CASAC Web site .

Finally, I want to say a comment on the status of this committee ' s compliance with federal ethics laws . The SAB Staff Office has reviewed information relevant to conflict of interest , appearance of a lack in partiality, and appropriate balance and breadth of expertise , knowledge and experience needed to address the charge and determined that there are no conflicts of interest or appearance of a lack of impartiality issues for any of the advisory members participating in this review .

A couple of housekeeping items , we got comments , late comments , from Dr . Hopke and Rich Poirot , which have been passed around .

And if anyone is on the phone besides Frank Speizer, could you identify yourself?

(No response . )1

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DR . STALLWORTH : No one ' s on the phone . Okay . I ' m going to turn it over to Dr . Vanessa Vu , the director of the SAB Staff Office for a brief welcome . OPENING REMARKS BY DR . VU :

DR . VU : Thank you . Good morning, everyone . I ' d like to welcome everybody to the public meeting of the Clean Air Scientific Advisory Committee , or CASAC, Review Panel on Particulate Matter .

First , I ' d like to thank Dr . John Samet , members of the Charter CASAC and members of the PM Panel for your time and public service to EPA for the last three years .

Probably some of you recall that the Panel was formed in 2007 . You all began with a consultation of the Integrated Review Plan , or IRP , in November 2007 . Since then you held altogether five public face
-to- face meetings , including this one ; and six teleconference calls ; and your comments and review with regard to two drafts , the I SA, the Integrated Science Assessment ; the Risk and Exposure Assessment , two drafts of it ; first draft of the Policy Assessment ; and finally, today you are going to provide review comments and advice to the Agency regarding the Primary and Secondary Standards for the1

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NAAQS for PM for this round of review .

Again, I want to thank each and every one of you for your time and very helpful comments to the Agency . I do know that the Agency represented by Ms . Lydia Wegman and Dr . Karen Martin would also appreciate your comments . They ' re all going to be here the next two days to provide an overview and clarify any questions regarding staff recommendations in consideration for the NAAQS for Primary and Secondary Standards .

As Holly mentioned, that we have public speakers , public comments . It ' s part of the process . Public input is part of the important process for the Advisory Committee of the CASAC and is required under the Federal Advisory Committee Act or FACA, so I appreciate that . As always , I know that Panel members consider public comments as a part of their discussion deliberation .

Finally, I ' d like to thank Holly . Holly has been the DFO for this review . And I just want to
acknowledge that when we began in November 2007 , that
was under the leadership of Dr . Rogene Henderson, and
now with Dr . John Samet ; and Frank Butterfield was our previous DFO for the PM Panel .

So I hope that we don ' t really have
-- I1

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presume we will have any comments from this Panel , if
we were -- after the Agency does a proposed rule making . And if you all wish to have some comments , we will do that ; but I will consider this as probably your last face
-to-face meeting for this panel .

And again , I thank you all . With that , I ' d like to turn the floor to Dr . John Samet . OPENING REMARKS BY DR . SAMET :

DR . SAMET : Thank you, Vanessa and Holly . Good morning, everybody .

Hearing you recount all our meetings , I ' m sort of reminded, it sounds like the never-ending story . I guess it will have an end . I think, in fact , for those of you who were involved in some of the prior PM reviews over the last decade , they did go on quite long, as you will remember .

DR . SPEIZER : I can barely hear you , John . DR . SAMET : Well , I can hear you . Can you hear me now? Frank?

DR . SPEIZER : Yeah . Very -- just barely . DR . SAMET : It ' s not me . It ' s you . DR . VU : Wait , Frank . DR . SAMET : I can ' t be any louder, or I could . DR . STALLWORTH : Frank, if Skype doesn ' t work
as well , you might need to go back to using the1

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-1896 (FAX) 8 phone . DR . SAMET : Where are you, Frank?

(No response . ) DR . SAMET : Well , why don ' t we do a round of committee introductions . Rogene , why don ' t we start with you and go around .

DR . HENDERSON : Okay . I ' m Rogene Henderson . I ' m Senior Scientist Emeritus at the Lovelace Respiratory Research Institute in Albuquerque .

DR . VEDAL : Sverre Vedal , Professor , Environmental Occupational Health Sciences , University of Washington, School of Public Health .

DR . SUH : Helen Suh, Department of Environmental Health, Harvard School of Public Health . DR . RUSSELL : Ted Russell , Georgia Tech, Department of Civil and Environmental Engineering .

MR . POIROT : Richard Poirot , State of Vermont , Department of Environmental Conservation .

DR . PINKERTON : Kent Pinkerton , Department of Pediatrics , University of California , Davis .

DR . MOORE : Tom Moore , Air Quality Program Manager for the Western Governors ' Association .

DR . MALM : Bill Malm, Colorado State University .1

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DR . LIPPMANN : I ' m Mort Lippmann, NYU Environmental Medicine .

DR . HOPKE : Phil Hopke . I ' m the director of the Institute for Sustainable Environment at Clarkson University .

DR . HELBLE : Joe Helble , Dean of the School of Engineering, Dartmouth College .

DR . FREY : I ' m Chris Frey, Professor of Environmental Engineering at North Carolina State University .

DR . CASCIO : I ' m Wayne Cascio , Professor of Cardiovascular Medicine at East Carolina University .

DR . BRAIN : Joe Brain, Harvard School of Public Health, the Department of Environmental Health . PROF . AVOL : Ed Avol , Keck School of Medicine , University of Southern California, Department of Preventive Medicine .

DR . ASHBAUGH : I ' m Lowell Ashbaugh, Project Scientist with the IMPROVE program, University of California , Davis .

DR . STALLWORTH : And Let me just point out that Dr . Kathleen Weathers is en route . Her plane
was cancelled last night . She ' s a senior scientist with the Cary Institute of Ecosystem Studies .1

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DR . SAMET : And Frank, are you on now? DR . SPEIZER : Yeah . I can -- are you there ? If you can hear me , I can barely hear everybody .

DR . SAMET : Okay . So we can hear you very well and we hear each other very well . So I don ' t know if there ' s something with the phone line that needs to be addressed, but we ' ll see .

DR . SPEIZER : Well , if I ' m very quiet , I can hear you .

DR . SAMET : Okay . So just to spend a moment
on what we ' re doing with our agenda . Again , of
course , we ' re reviewing the Second Draft Policy Assessment . We have worked in advance to prepare comments and responses to the charge questions . Today is directed at the Primary Standard, the NAAQS , and tomorrow at the Secondary Standard .

I think in terms of , sort of , what we get done and how far we can go in developing our formal responses , I think we better just see how the day goes . I think looking at the comments , there seem to be a great deal of agreement among the reviewers on where the document stands . It seems , as before , that perhaps much of the discussion will be around aspects of the Secondary Standard rather than the Primary, at least looking at the comments in some of the1

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-1896 (FAX) 11 remaining questions ; but we do adjourn tomorrow at 11 : 30 . Would also note that listening to the weather report , it doesn ' t look like any temperature records
are going to be broken today . It ' s not even going to hit 1 0 0 , it appears .

DR . STALLWORTH : What a relief . DR . SAMET : It appears , so a little respite for those of you from the east coast .

So with that , we ' ll turn things over -- I guess , Lydia , you ' ll start . OPENING REMARKS BY MS . WEGMAN :

MS . WEGMAN : Great . Good morning, everyone . I want to thank you all again for your participation . Hearing Vanessa ' s summary of all of the meetings for the very lengthy participation in this PM review, you ' ve given us a great deal of extremely useful advice . We really could not have made the progress we ' ve made without all the help you ' ve provided to us to date and we very much look forward to hearing the discussion today .

We thank you all for the written comments you ' ve sent us in advance of this meeting because they ' ve been very helpful to us in thinking about this meeting and preparing for it . So I just want to1

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thank you all very much for your help and service to
us in the Office of Air Quality Planning and Standards and EPA as a whole .

What I want to do is just introduce to you the team here who will be engaging with you throughout the next day and a half .

You all know Dr . Karen Martin . She ' s the group leader who has spearheaded this effort for the staff paper, or I should say Policy Assessment .

Beth Hasset-Sipple has been our lead person on the primary health phase PM2 . 5 standard .

Scott Jenkins has been the lead on the coarse particle standard .

Dr . Pradeep Rajan has been working with Beth
on the fine particle standards .

And for visibility, we ' ve got our two lead folks in the back, Vickie Sandiford and Marc Pitchford . And they ' ll be coming to the table a little later when we get to the discussion of the Visibility Secondary Standard .

Turning now to the schedule , which is what I want to talk about . Yeah, I just want to let you know where we plan to go from here . We do in fact hope there will be a conclusion to this review . That is our fervent hope . We are having a meeting, of1

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course , today on the Second Draft Policy Assessment and there is a public comment period which will last until August 16th, except that we have extended it to August 30th for Chapter 4 because Chapter 4 , related to the urban focus visibility discussion, went out later than the rest of the Policy Assessment . So we do have a two-week extension for public comments on Chapter 4 .

We plan to issue the final Policy Assessment in September of this year and then move forward to have a proposed rule in February of 20 11 and complete this review with a final rule issued in October of 2011 , which will be five years from the completion of the last review of PM . So that ' s the schedule we have in mind .

And now, unless anyone has any questions about the schedule , I ' m going to turn it over to Karen, who will talk about the document and give a brief
overview of what we ' ll be talking about today . OPENING REMARKS BY DR . MARTIN :

DR . MARTIN : Okay . It ' s my intent to do a very brief overview of the
-- primarily focusing on the things that have been added or changed in the second draft relative to the first draft that you reviewed previously, as well as just a very quick1

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summary of the staff conclusions for these chapters .

With regard to the structure of the document , obviously, there ' s two chapters that deal with the Primary Standards , two with Secondary Standards . The focus of our charge questions and the focus of, therefore , this discussion will be on Chapters 2 , 3 and 4 . Chapter 5 , there were limited comments from this panel on the first draft . We addressed those comments ; therefore , we didn ' t identify additional charge questions for this second draft on that chapter, but the second draft includes changes we made to that chapter that were reflective of the comments we received on the first draft .

And turning to -- just looking, first of all , at overall changes to the document as a whole , your comments on the first draft were very pointed and focussed us on streamlining the document , removing redundancy, relying more on the related assessment documents , which we have made every effort to do , we added an Executive Summary .

We focussed in particular at the beginning of these chapters to articulate the approach we were using throughout the chapter . As part of our assessment we added, sort of , a road map figure to1

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-1896 (FAX) 15 highlight that up front to give the reader a better
sense of what was to come , an organization of what
was to come . And we tried therein to more strictly follow the approach laid out up front as we went about the discussions primarily on alternative standard levels that the approaches spoke to most when we got to that part of the chapter .

And finally, for all the chapters we included the last section on key uncertainties and areas for future research .

With regard to Chapter 2 , additional analyses and discussions that are included in this draft , we particularly clarified our approach for translating epi evidence into the basis for staff conclusions primarily on levels of the standard . This chapter
now includes additional analyses that informed conclusion on alternative forms of the standards , looking both at the annual standard and potential disproportionate impacts on susceptible populations , as well as looking at a comparison of the 9 8th and 9 9th percentiles for the 24

-hour standard .

With regard to levels , and in particular on the annual standard, the approach discussion lays out
a couple different approaches to translate epi evidence into levels of the standard . This was the1

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-1896 (FAX) 16 subject of much discussion among this Panel followed
on the first draft , and we have brought that discussion forward here .

In particular , I will note that the discussion
on looking at confidence bounds around concentration

-response functions was something that
was highlighted a lot in your comments . We presented
a discussion here upon receiving comments , particularly comments from Dr . Vedal , on that particular issue . We revisited what we had written, and we took the step of conferring with investigators
on the three key studies that we called out as being particularly relevant to that discussion to get more information on the analyses they did and their views about interpretation of those analyses .

So what I would like to do , rather than taking
more time now, I would like to just , when we get to that point in talking through the charge questions , I ' d like to provide an overview of the evolution of
our thinking since we released the second draft as informed by some of the
-- and conferring with some of the authors there .

Beyond that , then , we put together, hopefully, a more logical discussion of looking at different statistical metrics and talking about drawing from1

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the risk assessment to help inform beyond the evidence itself our consideration of alternative levels . In looking at the bottom
-line conclusions that
we reached, which hopefully are clearly expressed in the Executive Summary of the document , we conclude that the available information , the evidence in the risk information, clearly calls into question the adequacy of the current primary fine particle standards , that we ' ve identified alternative forms and levels that are appropriate for consideration based on that information, appropriate to consider eliminating spatial averaging for the annual standard, appropriate to consider retaining the 98th percentile for the 24

-hour standard .

And with regard to levels , we have a discussion about considering information on both long
-term and short
-term exposures as part of providing the basis for defining a generally controlling annual standard in conjunction with the 24

-hour standard that will provide supplemental protection . And in that regard, we identified annual standard levels in the range of 13 to 1 1 as appropriate for consideration; and we looked at the 24

-hour standard levels then in conjunction with the1

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annual standard levels and conclude that it ' s appropriate to consider retaining the level of 35 micrograms per cubic meter in conjunction with any of the annual standards and, alternatively, to consider
revising the 24

-hour standard level lower to a level of 30 in conjunction with an annual standard level as low as 1 1 . And as we get to those charge questions , I ' m sure we ' ll have discussion about those conclusions .

With regard to Chapter 3 , thoracic coarse particles , we have appreciably expanded the analyses and discussions in this second draft . The first draft was not fully complete in discussing alternative levels , so there is much more new material in this chapter than in the others .

In particular , expanded the discussion of approaches to evaluating the adequacy of the current PM10 standard, added figures characterizing PM10 air quality in locations where we had PM10

-2 . 5 health studies . We expanded the discussion of the epi evidence and the air quality information as it relates to the adequacy of that standard .

We added discussion with regard to additional analyses to inform consideration of the indicator and focusing on the relationship between PM10

-2 . 5 and PM101

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concentrations in regions across the U . S .

We ' ve expanded discussion of relevant considerations for the form of the standard looking at the current form, which is a one-expected
-exceedance form averaged over three years relative to a 9 8th percentile form .

And in discussion of levels , to the extent that consideration is given to revising the standard to look at potentially more protective standards , we ' ve done additional analyses that looked at the relationship between the current and potential alternative standards and added figures characterizing, again , PM10 in locations of PM10

-2 . 5 to help inform that discussion .

With regard to the overall staff conclusions from Chapter 3 on thoracic coarse particle standards , we conclude that the available evidence and air quality information could support either retaining the current standard or revising the current PM10 standard depending on the weight placed on different kinds of evidence and the weight placed on the uncertainties associated with that evidence .

To the extent that revisions are considered, we concluded that it would be appropriate to give consideration to retaining PM10 as the indicator with1

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a 24

-hour averaging time and to revising the form and level with consideration of levels between 85 and about 65 micrograms per cubic meter in conjunction with a revised form in conjunction with the 9 8th percentile form . So that discussion starts with the point of very rough equivalence between a one-expected
-exceedance form and the 98th percentile form in terms of levels and then goes from there to discuss potential alternative lower levels of the standard .

With regard to Chapter 4 , looking at visibility

-related effects and secondary standards intended to protect against visibility impairment , we have done a reevaluation of the choice of an indicator drawing a lot on comments from this committee as well as comments from the monitoring subcommittee , the AAMMS subcommittee . In this regard, the first draft included a discussion of two different indicators , an indicator of light extinction using direct remeasured light extinction, and an indicator of aggregated PM2 . 5 mass . There were a lot of discussions about the pros and cons of those different indicators , a lot of issues raised about both of them . We went away and thought about the limitations and concerns with either one of them and1

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tried to develop a, sort of, hybrid approach that defined the degree of protection in terms of light extinction and utilized speciated PM2 . 5 mass information and humidity information to calculate a light extinction . Therefore , we defined the ineloquently termed speciated PM2 . 5 mass calculated light extinction indicator, thinking that it reflected potentially the advantages of the two different options explored in the first chapter and avoided some of the fundamental limitations in moving forward with them; and we conducted new analyses to inform consideration of alternative standards .

One point I would make here is one of the things that happened as well is that they identified
a processing error, a data processing error in the urban focus visibility assessment , the underlying quantitative assessment document . That error caused organic carbonaceous materials , estimated by the Sandwich method, to be overestimated on some days . It took a while to play this error out through the calculations . The bottom line is the corrections are quite small . They don ' t in any way affect the conclusions , but it did take a while to work through that . As a consequence , that visibility assessment document was not released at the end of June when1

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when we anticipated it would be released, but it was released just the end of last week so that we could fully play through this correction . And that is the basis for extending the comment period on Chapter 4 of this Policy Assessment document . Chapter 4 was , of course , released at the same time as the whole Policy Assessment document ; but this analysis was -- underlays and informed that chapter, so we ' ve provided some extension of the time for public comment on Chapter 4 . And we have included updates in that final figure , and the Policy Assessment was really not affected by this error correction since it didn ' t play a role in the newly developed indicator approach that we present here .

Bottom-line conclusions on Chapter 4 then , the staff concluded that the currently available information clearly calls into question the adequacy of the current PM2 . 5 standards to protect against visibility impairment . We ' ve identified alternatives that we believe are appropriate for consideration particularly focusing on the new speciated mass calculated light extinction indicator focusing on daylight hours only, focusing on only hours with relative humidity of 90 percent or below, looking at
a one-hour averaging time , all of which carries1

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forward from the discussion in the first draft . Also , looking at alternative forms , both the maximum daily one-hour form in conjunction with 90th or 95th percentiles , or looking at all daylight hours in a day in conjunction with the 98th percentile form . There ' s obviously a lot of different permutations one can look at , and we focussed on those as , perhaps , being most meaningful to compare .

And in conjunction with levels , we look in terms of defining the degree of protection of a standard in terms of light extinction in the range of 64 to 19 0 inverse megameters , which is , again , a carryover from the range that was considered in the first draft

So that ' s the overview, and if there ' s any questions .

DR . SAMET : Okay . Thank you , Karen and team . I think these figures and, sort of, the clarity of the approach, I think, is very useful . I
mean , if you , sort of , extend it up to the top of the page and put it in the ISA and the REA, you could capture the whole process , which might be a useful thing to do . Congratulations on creating an indicator that defies acronyms .

Questions or clarification from the Panel ? I1

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mean , we ' ll have a lot
-- I mean , obviously, once we go through the details , we ' ll have specific items to discuss ; but , I think, in terms of the overall approach, the overview, anything?

(No response . ) DR . SAMET : Okay . We should just go to the public comments . Then what we ' ll do is move on to the public comment period . We have eight public commentors . We have time allocated until 10 : 30 . Each public commentor has been allocated five minutes . We ' ll ask you to come forward to present . What I will do is , I will give you a 30

-second warning; and I ask that when we reach the five minutes , that you please end your presentation .

Our first presenter is Jay Turim from Exponent , Inc . on behalf of the American Chemistry Council , please . PUBLIC COMMENT STATEMENTS BY : DR . JAY TURIM :

DR . TURIM : I ' m glad to be here for the third time to speak about the PM standards . In a sense , the most important document in the NAAQS review process is the Policy Assessment since it ' s intended to bridge the gap between the highly technical information presented in the I SA and the Risk1

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Assessment and the judgments required from the Administrator in making her decisions .

Instead of plowing through the very detailed scientific documents prepared by EPA in the past , the Administrator will very likely rely heavily on the Policy Assessment when fashioning her own judgments as to the adequacy and whether the standard should be changed . For that reason the Policy Assessment should present a very balanced view of the state of the science .

In the very little time allotted to me -- and I learned last time the five minutes does mean five minutes

-- I ' ll touch on just a view of the ways the Policy Assessment , we feel , falls short . Many other examples are given in our written comments that we ' ve submitted to the CASAC committee and to EPA .

In the comments we submitted on the first draft as well as the second, we discussed the
numerous limitations in the epidemiological studies relied upon by EPA . Among them, limitations of the observational studies generally, the unreliability of the statistical methods used, inconsistencies among the studies , and the implausibility of some of the results .We were very surprised to see that the first1

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draft of the Policy Assessment did not discuss or even acknowledge many of the numerous issues and suggestions we commented on . We don ' t expect the EPA to agree with every point we made , but we believe it is incumbent on the Agency to address these issues , not in a stand
-alone document , as was done , for example , with the comments submitted on SO2 , but in the Policy Assessment itself since that is the document that the Administrator will rely upon in making her decisions . I ' d like to mention two issues specifically, again , in recognition of the little time I have to speak .

Reported risks in some studies relied heavily upon by EPA staff are so large as to be totally implausible biologically . One example is a study that plays an important role in EPA ' s considerations , the Miller , et al . , 2007 , estimated cardiovascular events including deaths associated with fine PM exposure . Their results imply that the risk of a woman living in the most polluted city

-- I think it
was Riverside , California, in terms of the cities studied by Miller , et al . -- dying from heart disease is four times higher than for a woman living in the least polluted city, which was Honolulu , Hawaii . This compares with the relative risk of less than two1

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for a two-pack
-a-day 65
- 69 year old woman smoker . Does EPA really believe that the risks from fine PM at current ambient levels are greater than smoking? If so , then EPA should state so explicitly .

The second issue I want to speak about briefly regards the ACS II studies . In an update of the ACS II cohort , Krewski , et al . , in 2007 , showed that when SO2 exposure was taken into account , the magnitude of the association of mortality with fine PM was not statistically significant . Subsequently, several other studies , Pope , Jerrett , Krewski , all of which
were , in part , in EPA ' s thinking, were conducted with the same data . In fact , the Krewski , et al . , 2009 report provides the fine PM mortality coefficient that was used in the risk assessment that was the basis for some of the Policy Assessment results . None of the analyses I mentioned included SO2 in joint

-pollutant analyses with fine PM despite the very strong findings in the original Krewski reports --

DR . SAMET : 30 seconds . DR . TURNER : -- and despite repeated attempts to have such analyses conducted .

To conclude , we think that at absolute minimum the Executive Summary has to be rewritten . Clearly1

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it was done in comment to , in response to , CASAC ' s comments ; but it does not say anything about the uncertainties of the data, only repeats what the body of the report included .

And finally, the second point we want to make is the report is so --

DR . SAMET : Thank you for your comments . Your time is up . Thank you .

DR . TURIM : Thank you . Almost got it through this time .

DR . SAMET : Five minutes is five minutes . Let ' s see , why don ' t you wait a moment and see if there are questions from the Panel .

Sverre ? DR . VEDAL : Yeah, thanks for that . I had just
a question . I didn ' t catch what the concern was with the Krewski reanalysis . I missed it .

DR . TURIM : The Krewski analysis did not take into

-- the 2000 analysis did a multi

-pollutant analysis

--

DR . VEDAL : Right . DR . TURIM : -- which showed that SO2 diminished the association . And there were no other multi

-pollutant analyses included in the 2009 Krewski report , which is at the heart of some of the1

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deliberations of EPA .

DR . SAMET : On a technical point , you mentioned unreliability of statistical methods , and there ' s a specific reference in your written comments to the Cox model .

DR . TURIM : Right . DR . SAMET : One of those widely used statistical techniques throughout , really, observational studies , clinical literature and so on . Is there some particular aspect of the Cox model and its application that you found lacking?

DR . TURIM : Yes . Well , we speak about some of those details in our report .

The Cox model we don ' t think echos the actual data in the sense that the Cox model does not reflect the fact that the risks go down over time . And I think we give some illustrations in the report we submitted on that . We have the figure of that . I don ' t have it in front of me , Dr . Samet .

DR . SAMET : Okay . But the Cox model can incorporate time dependence . I ' m not -- we can perhaps look because I did not see any real details
on this

--

DR . TURIM : Yeah . DR . SAMET : -- in your comments .1

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Any other questions from the panel ? (No response . ) DR . SAMET : Thank you for your comments . DR . TURIM : Thank you . DR . SAMET : Okay . We ' ll move to our next speaker, Deborah Shprentz , consultant on behalf of the American Lung Association . MS . DEBORAH SHPRENTZ :

MS . SHPRENTZ : Thank you and good morning . I ' d like to focus on just a few issues regarding the rationale underlying the recommendations in the draft Policy Assessment .

First , with respect to the fine particle standard, the draft states that it might be appropriate to consider a more protective 24

-hour standard of 30 but only in conjunction with the most protective option of an annual standard of 11 . The draft allows that it might be appropriate to consider this tighter daily standard to protect against strong local or seasonal sources of emissions that result in high daily concentrations despite the annual average standard . However, in our view it does not make
sense to consider a tighter 24

-hour standard of 30 only in conjunction with the most stringent annual standard under consideration . If daily1

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concentrations are of concern with a standard of 11 , they ' re even more so of concern with an annual standard of 12 or 13 because a higher annual standard will be less effective at moderating 24

-hour peaks than a lower standard .

The justifications offered by the draft Policy Assessment don ' t hold up . First , the draft states that the annual standard should be controlling, but the NAAQS must protect public health even if the 24

-hour standard is controlling in some areas . This whole idea of the controlling standard is not germane to selecting standards and has no statutory basis in the Clean Air Act .

Second, the draft Policy Assessment purports to set a 24

-hour standard based on the average peak
-to-mean ratio in most regions of the country of 2 . 5 . The Policy Assessment states that it ' s reasonable to focus on 24

-hour standards that are at least 2 . 5 times the annual standard . This is used to argue that the current level of the standard of 35 meets this criterion . But again , the goal is to identify a level that will protect public health, not to maintain the annual standard as controlling .

The draft Policy Assessment further justifies its failure to consider tightening the 24

-hour1

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standard based on regional considerations . EPA ' s analysis of the air quality data shows that a standard of 11 annual and 30 daily would primarily impact the northwestern region of the country where emissions from wood stoves and agricultural burning
are problems . A standard of 30 or 25 in conjunction with an annual standard of 13 or 12 would affect additional regions of the country . This regional justification is not allowed under the Clean Air Act and is bad policy because it would fail to provide equal protection throughout the U . S .

With respect to the coarse particle standards , we ' re dismayed that the Policy Assessment contemplates a relaxation of the form of the 24

-hour standard . The current form is the
one-expected
-exceedance form and the draft suggests moving to a 98th percentile form . The goal of the daily standard is to prevent peak daily exposures ; and as we ' ve argued in the past , a 9 8th percentile form of the standard excuses too many days of
unhealthy air quality from the compliance determination seven days each year . The continued
reliance on one-in

-six

-day monitoring or one-in

-three
-day monitoring is not a reason to move to a 98th percentile standard . Indeed, it ' s past1

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time to require daily monitoring of PM10 concentrations . Even if EPA lowers the level of the 24

-hour standard to compensate for a more lenient form, it will not address our concerns . The Agency needs to consider the practical effect of a change in form that does not increase the protectiveness of the standard, that being to delay the delivery of health benefits . States would have to reclassify
non-attainment areas , develop new implementation plans and the deadlines for attainment would be extended, meanwhile cleanup efforts will be stalled .

The draft Policy Assessment argues that the PM10 indicator for coarse particles is desirable because it would allow less coarse particle pollution in urban areas than in rural areas and that this is a good thing because urban coarse particles are more toxic ; but toxic coarse particles are present in rural as well as urban areas , so this is not a valid consideration . Mobile , off
-road and stationary combustion sources are located in rural and urban
areas . DR . SAMET : 30 seconds .

MS . SHPRENTZ : And likewise , industrial
sources of emissions are found in less populated
areas . We believe that national standards have to1

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protect all citizens , urban and rural alike .

Thank you . DR . SAMET : Thank you . Questions ? Comments ? (No response . ) DR . SAMET : Okay . Thank you , Deborah . Our next speaker is Ben Brandes , Director , Air Quality, National Mining Association . MR . BEN BRANDES :

MR . BRANDES : Thank you for your time . My
name is Ben Brandes . I ' m with the National Mining Association .

NMA is a national trade association of mining and mineral processing companies , whose membership encompasses producers of most of the United States metals , coal , uranium and industrial and agriculture minerals . NMA members operate all across the country including the western United States where coarse PM, fugitive dust predominates due to the air conditions .

NMA is very concerned that the decision by EPA to reduce the level of the current PM10 standard will throw many areas around the country into
non-attainment . This will have the effect of limiting economic growth and impacting development and operation of existing operations in those areas .1

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We understand that EPA cannot consider economic effects when establishing the air quality standards ; therefore , added emphasis should be placed on making balanced decisions based on existing scientific information .

EPA staff concluded in the second draft Policy Assessment that consideration could be given to either retaining or revising the current standard . Further, staff noted that the currently available scientific evidence could be interpreted to support retention of the existing standard . This conclusion is justified by the scientific limitations and
uncertainties the EPA has identified in the currently available health studies .

Despite the scientific support for retaining the standard, however , EPA staff suggested a potential alternative in the document that would effectively result in tightening the current standard by half . The impact of PM10 regulation on sources of PM coarse , particularly on surface mining operations in the western United States , could be severe . Because mines are already required to control coarse PM through a variety of technology and management requirements , little more can be done to comply with the coarse PM NAAQS other than to scale back or shut1

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down operations .

The impacts of a coarse PM standard to energy and commodities markets , not to mention the communities and ancillary businesses that depend on mining, would be substantial , sending ripple effects throughout the entire economy . Because of longstanding concerns with the lack of evidence of adverse health effects at ambient levels , historically EPA has not regulated rural fugitive dust in the same manner as other particulate matter, especially PM found in urban areas .

With the health evidence increasingly pointing to PM fine as the PM10 component of concern , CASAC and EPA have both recognized that PM fine and PM coarse and are two distinct pollutants . PM fine is combustion

-derived material . PM coarse is crustal , mechanically derived material . While EPA proposed eliminating PM10 24

-hour standard in 19 97 because of a lack of adverse health effects from coarse PM and found in 2006 that the health evidence continued to be inconclusive and uncertain, EPA did retain the PM10 standard as a coarse PM indicator in 2006 as a cautionary measure .

EPA also continues its finding that rural fugitive dust is of less concern than urban PM . EPA1

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noted a potential concern with urban coarse PM due to the possibility that fine particles could contaminate the coarse particles . No independent evidence was adduced that coarse PM was a health concern . The health evidence for coarse PM continues to be comprised by the reliance on PM10 in the epidemiological studies . As CASAC ' s own members have acknowledged, when PM10 data is used as the basis for finding adverse health effects , one cannot know whether it is the PM fine component of PM10 or the PM
coarse component that is responsible for the observed effects .The final I SA adopted this past December recognizes that the most thorough and best quality studies find no adverse health effects from coarse PM . In fact , there remains no evidence that rural
coarse PM of the type associated with mining operations posed adverse risks to human health or the environment at ambient levels .

For all of these reasons , NMA supports the conclusions by EPA in the Policy Assessment that the existing 24

-hour standard for coarse PM should not be revised due to the critical distinction between
--

DR . SAMET : 30 seconds . MR . BRANDES : Thank you .1

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-- should not be revised due to the critical distinction between urban and rural coarse PM and the continued uncertainty in the health evidence .

Thank you for your continued work and consideration .

DR . SAMET : Thank you . Questions or comments ? (No response . ) DR . SAMET : Okay . Thank you . We ' ll move to our next speaker , Greg Schaeffer, vice president of external affairs , Arch Coal , Inc . MR . GREG SCHAEFER :

MR . SCHAEFFER : Hi , Karen . Good morning . My
name is Greg Schaefer , and I ' m with Arch Coal . We ' re the second largest coal producer in the United States , and we operate two surface coal mines in the Powder River Basin of Wyoming, which is largely in an arid

-- hi , Tom -- largely in an arid and windy environment , so we do see dust out there .

We ' ve been actively engaged in the particulate matter reviews over the years and have watched as EPA and CASAC have struggled with developing PM standards that are protective of human health, but at the same time are not disproportionately more stringent in
some areas in the United States . This struggle1

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continues today . This has been the case for the western United States due to the high proportion of
coarse particulates in the PM10 fraction and the relative absence of fine particulates .

On page 3

-38 of the Policy Assessment , EPA notes : Based on regression of 9 8th percentile PM10 design values and the 9 8th percentile PM10 concentration of 87 micrograms per cubic meter is on average equivalent to a one-expected
-exceedance design value of 150 micrograms per cubic meter . As a consequence , while we note that a 98th percentile 24

-hour PM10 standard with a level of 87 micrograms per cubic meter would be expected to provide public health protection that is , on average across the United States equivalent to the protection provided by the current standard, in some locations such a 98th percentile standard could be more protective than the current standard while in other locations it could be less protective than the current standard .

And that ' s our concern is , once again , it looks like this will be disproportionately more stringent in the west . We ' ve see on the 98th percentile that there ' s significant variation from year to year . At one of our monitors in 2008 , the 98th percentile was 95 micrograms per cubic meter,1

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while in 2007 was 8 0 micrograms per cubic meter . And that ' s going to be largely a function of how close the mining operation is to the monitor, and also it will be the amount of moisture we have during the year because we are in an arid environment . We continue to urge EPA to seek a fair resolution to the fairness issue associated with the coarse PM standard, which includes maintaining the coarse -- or the 24

-hour standard at 150 micrograms per cubic meter . Attention also needs to be applied to areas that have high density of coarse PM monitors . In these areas one monitor may show an exceedance of the standard while the one adjacent to it is in compliance . It doesn ' t make sense to treat coarse particles like ozone or NOx, which have very long distance transports , while coarse particulate transport is very short .

Thank you for your attention today . DR . SAMET : Thank you . Not even a 30

-second warning MR . SCHAEFFER : That ' s what I was shooting for . DR . SAMET : Okay . Thank you . Questions or comments ?1

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(No response . ) DR . SAMET : Okay . Thank you . We ' ll move to
our next presenter, Wig Zamore from the Somerville Transportation Equity Partnership and Mystic View Task Force .

Actually, Frank, can you hear this ? DR . SPEIZER : Yes . DR . SAMET : Okay . DR . SPEIZER : Yeah, I ' m hearing you now . DR . SAMET : Okay . DR . SPEIZER : I ' m not hearing anything now . MR . WIG ZAMORE :

MR . ZAMORE : Okay . Sorry . All right . This is Wig Zamore . Thank you very much for giving me a couple . . . .

DR . SPEIZER : Okay . MR . ZAMORE : I can sit down and just turn . I think I can do it from here if this will work .

Thank you very much for giving me a few minutes of time . I ' m an average citizen from Somerville , Massachusetts ; and you were nice enough to give me a few minutes 15 months ago in Chapel Hill .

I ' m going to do a PowerPoint . This is a recent picture of conditions on I- 93 in the afternoon1

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in Somerville . Increases are pretty substantial in highway travel in Massachusetts , about 25 million vehicle miles per day per 20

-year period .

Of course , it ' s not all highway . Here ' s flying in yesterday to RDU . Here ' s the ports of LA and Long Beach . And just while we ' re there , I ' d like to mention the California Children ' s Health Study, which started out looking at regional transportation , found some associations with ozone for four
-season outdoor athletes and with PM2 . 5 strong enough to cause a remand of the PM2 . 5 standard, but consider their findings of roadways to be most , most significant .

With regard to the current standard my main point is that the numbers are very large and call for the strictest annual PM2 . 5 standard possible . I think
no matter what standard you pick, the mortalities left on the table will exceed the mortalities associated with all other environmental health issues in the United States .

Ischemic heart disease , of course , is a very large issue here , and I want to talk a little bit about that in connection with ultrafines . It seems that ultrafines are strongly associated with ischemic heart disease and perhaps also still neurological function . A lot of studies showing acute effects1

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both in daily mortality and then in biological indicators , starting with the Germany series and then
more recently, with a series of studies in the U . S . including rodent studies .

Moving to subchronic, which ties this to longer
-term cardiovascular disease , both the Delfino senior citizens studies in California and Hertel and Hoffman in Germany have found strong association of UFP with high

-sensitivity CRP of over a week of averaging, up to a month of averaging, which is the extent of their research . And here ' s a slide from Hertel showing how much stronger the UFP are than PM2 . 5 or PM10 , effect modification for both age and body mass in the studies .

Back to Somerville , we have a lot of citizens who do not understand this issue because there ' s no government direction, joggers , bicyclists . Panis has found almost an order
-of
-magnitude increased dose for bicyclists . Here ' s a young woman and her young daughter thinking they ' re doing the right thing, and this is where they are . This is what they ' re doing almost every afternoon .

Same thing with our housing, we ' re locating
our housing extremely close to the highway . On the right is the largest affordable housing project in1

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Somerville . In the middle , the newest affordable housing project in Somerville , Interstate 93 just off the screen to the left .

A nice study
-- I know it ' s too late to include in your review

-- but out of Vancouver, by an associate , Michael Brauer, showing, similar to the Children ' s Health Study in California, that when people move in or out of highway

-adjacent locations it modifies the cardiovascular mortality response . You can see that the effects are very, very large here , especially for people living within 50 meters of highways and even after modifying for socioeconomic .

These are pretty much the summary of the numbers I presented 15 months ago . I still believe these to be true . I ' m concerned that we ' re not moving to primary mobile pollution soon enough, and I think the particulate matter committee is the place to do it .

Here ' s a young woman in Somerville hung up on an arterial highway . You can see from her expression she ' s trying to reach the EPA PM scientists in CASAC .

And the question is , what can we do about it ; and I ' m going to stop there . And I guess I would ask just for those two things . A strict PM2 . 5 annual1

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standard and some pathway to telling you, as citizens who exercise or live next to highways and other large mobile sources , that they are at risk .

Thank you . DR . SAMET : Thank you . Questions or comments ? Is that Joe Brain in one of those cars commuting?

DR . BRAIN : Not mine . My son and grandson live in Somerville .

DR . SAMET : Our next presenter is Julie Goodman from Gradient on behalf of the American Petroleum Institute . DR . JULIE GOODMAN :

DR . GOODMAN : Thank you for the opportunity to speak today on behalf of API .

The second external review draft of the PM Policy Assessment has not substantially changed from the first draft . EPA continues to rely on results from a small number of epidemiology studies with large inherent uncertainties to support lowering the PM NAAQS . I ' ve commented extensively on the limitations of these studies , particularly as to their relevance and informing changes to the NAAQS , yet EPA has not been responsive to my comments .

Today I will focus on three points that EPA1

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should consider before finalizing the PM Policy Assessment . They specifically relate to the assumption of no threshold, the evidence

-based analyses , and the bases for the alternative annual PM2 . 5 standard .

EPA asserts that there is no evidence of a threshold for PM effects and that a log
-lineal model best represents the concentration

-response , or C-R relationships . Yet , several researchers have shown that these relationships are nonlinear . In fact , exposure measurement errors in epi studies , acknowledged by EPA, have been shown to result in biases in fitted C-R curves that are large enough to affect the interpretation in risk assessment applications , and these biases can mask true thresholds .

Other arguments claimed to support
no-threshold models , such as additivity to background and heterogeneity in the population, do not actually support this assertion . Additivity to background only holds if it ' s related to a specific mode of action that has non-universal properties , properties that would not be expected for noncancer effects . Similarly, heterogeneity among members of the target population do not linearize the C-R curve , but rather1

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tend to broaden it .

As to my second point , EPA continues to assert that new epi evidence is consistent and stronger, quote , "because of its breadth and substantiation of the previous observed health effects . " But I ' d like to quote Bradford Hill from his seminal 1965 paper where he says , quote , " The same results from precisely the same form of inquiry will not invariably greatly strengthen the original evidence . " So in other words , a larger number of studies that show the same limitations as a smaller subset does not strengthen the argument of a causal effect . And in fact , the studies continue to show that changes in model specification or model assumptions as well as the inclusion of confounders significantly changes effect estimates .

As to my third point , to support the recommendation of alternative PM2 . 5 standards , EPA relied on data from a select few studies without properly weighing the data and uncertainties from all studies across all lines of epi , animal , and mode of action evidence . In the ISA, EPA claims that findings of cardiovascular and respiratory disease
are consistent and precise above 13 micrograms per meter cubed, but a review of the data shown in Figure1

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2

- 1 and 2

-2 of the ISA shows this is not the case . A higher value , where results are more consistent
across studies , should be considered to support the standard . And in addition , the lower
-bound recommended alternative standard of 11 is based on studies of health effects that are considered only suggestive at this time and should not be included in the recommendation .

So the evidence presented by EPA is not sufficient to change the level of the standard given the uncertainties in the epidemiology studies relied
on and the use of arbitrary statistics that are , quote , " just below the mean" in a select number of studies , without consideration of the larger body of evidence .

Indeed, EPA has discussed the increased uncertainty in risk estimates below 13 microgram per meter cubed largely due to the lack of data at these levels . For example , as noted in the second draft PA, the studies that show C-R functions with confidence bounds demonstrate greater uncertainty, in the terms of wider confidence bounds , below the level of the current standard . Similarly, EPA has noted that it does not have confidence in risk estimates of alternative standards below 13 .1

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So in conclusion, the uncertainty in the
underlying epi studies precludes the conclusion that
a causal relationship exists between PM and health effects below the current standard . Furthermore , there ' s evidence the C-R relationships are not linear , that a threshold likely exists , bringing into question the results from the risk assessment . And lastly, the bases for the alternative standard appear to be arbitrary and are not supported by the current scientific evidence . So the current weight of evidence does not call into question the adequacy of the current PM2 . 5 standard .

Thank you DR . SAMET : Thank you . Questions , comments ? (No response . ) DR . GOODMAN : Okay . Thank you . DR . SAMET : Thank you . Our next speaker is Jon Heuss from Air Improvement Resources , who is on, I guess , by phone .

Jon, are you there . MR . HEUSS : Yes , I am . DR . SAMET : Okay . Go ahead, please . MR . JON HEUSS :

MR . HEUSS : Thank you . My name is Jon Heuss , with AIR .1

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-1896 (FAX) 50 George Wolff and I provided written comments
on the first draft PA . In addition, Charles River Associates , Gradient , and the American Chemical Council , provided important comments . These submissions raised substantive issues relevant to the policy choices in the PA, yet the second draft either does not acknowledge or insufficiently acknowledges these concerns .

The most important points are : One , assumption of equal toxicity by PM mass undergirds the risk analysis is flawed . All the discussions of causality in the PA must be qualified as they were in the 2004 SCD to refer to PM, or one or more PM component acting alone and/or in combination with gaseous pollutants rather than just to PM mass alone . In the last review, the administrator placed little weight on the risk assessment since it was not clear that controls that would reduce the fine PM would also reduce the toxic components . That concern is still relevant .

Two , the epi evidence is not as strong or as consistent as portrayed in the PA . New large U . S . multi

-city studies show that the magnitude of PM associations with acute morbidity and mortality endpoints is smaller than thought in 2004 . The1

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pattern in the multi

-city studies shows that when you look just at single

-city studies , there is an upward bias due to publication bias . The multi

-city studies also provide strong evidence that stochastic variability is much greater than heretofore thought and shows clear spatial and temporal patterns that
are not consistent with effect of generic PM . The PA should acknowledge these patterns and conclude that relying on specific single

-city studies in light of the stochastic variation is unsound . All these findings provide support for the conclusion the current standards adequately protect the public health . Three , model selection uncertainty is more important than acknowledged in the PA . HEI ' s recently released APHENA study shows a pattern of combined association that is not consistent with what
one would expect if PM10 health associations have a real physiologic basis .

Four , if EPA claims that PM mass regardless of composition causes health effects , then a comparison of PM risks in other exposure situations is warranted . The cardiovascular health signal relied upon by EPA is not consistent or coherent with the fine PM risks from indoor pollution in developed1

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countries , massive indoor pollution in underdeveloped countries , smoking, and occupational exposures .

Five , the arguments the PA uses to defend making the annual fine PM standard more stringent lack rigor . The cardiovascular signal observed in the Eastern U . S . in the large ACS and Medicare cohorts is not present in the Western U . S . It ' s also not present in the large cohort study from the Netherlands , Beelen , et al . , 2008 . These spatial differences and inconsistencies in the chronic mortality studies lend additional credence to the conclusion that to the extent that there are positive PM associations , they are caused either by unidentified covariates , by components of PM, not PM
mass , or by historic high exposures and sources unique to the Eastern U . S . These possibilities are not discussed in the PA . Even if these possibilities
are dismissed, Charles River and Gradient comments concerning the lack of knowledge of the appropriate exposure period for attributing the effects that are in the remaining cohorts that may cause recent associations . These need to be fully vetted in the PA . Thus , there is substantial evidence in supporting retaining the current annual PM2 . 5 standard that is not being considered in the draft PA .1

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With regard to coarse PM, we agree with EPA that urban and coarse -- rural coarse thoracic PM should be treated equally . We think EPA should focus
on identifying the toxic components of ambient PM . Tightening the generic fine or coarse PM standards without knowing what causes the wide variations from positive to negative in acute individual

-city associations , or the region

-wide chronic PM associations at the same PM exposure , is scientifically unsound .

And I would add a seventh point . Since there ' s a similar pattern of acute associations for each of the criteria pollutants , the extent to which gaseous pollutants
--

DR . SAMET : 30 seconds . MR . HEUSS : -- can cause the biological responses attributed to PM to be rigorously
evaluated . As each criteria pollutant is being reviewed, EPA is using selected single

-city, single

-pollutant associations for that pollutant to set the NAAQS , for example , in the recently completed NO2 and SO2 reviews . And the recent ozone proposal
uses epi evidence as the main reason to support a low end of the proposed range .

Now, in the PM case selected single

-pollutant1

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individual

--

DR . SAMET : Okay . Jon , your five minutes
are -- your five minutes are done .

MR . HEUSS : -- city associations are being used in Chapter 3 to evaluate the range --

DR . SAMET : Jon? MR . HEUSS : -- potential 98th percentile PM10 standard . Aside from the issues of
--

DR . SAMET : Thank you . Your five minutes are done . Questions ?

MR . HEUSS : -- potential double or triple

-counting of
-- published single

-estimate , single

-site analyses is an --

DR . SAMET : Let ' s see , Jon , I don ' t know if you can hear me ; but you ' re over time and we ' ve lost you for the last 20 or 30 seconds in any case . Thank you . Our next comment is from John Richards , Air Quality Control Techniques on behalf of the Coarse Particle Coalition . DR . JOHN RICHARDS :

DR . RICHARDS : Good morning . I ' m John Richards . I work for Air Control Techniques , which is a North Carolina based engineering and testing company . I ' m representing the Coarse Particulate1

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Matter Coalition . That includes five organizations shown here , and collectively they represent about 10 , 000

-- I mean, 100 , 000 employees .

I appreciate the opportunity today to present
seven points that are discussed in considerably more detail in our written comments . I ' m just going to
cover them as bullet items . If time permits , I ' ll return to the first one , but I ' d like to go over all
seven in the short time that I have .

Number one , we ' re concerned that the spatial
nonuniformity of the coarse particulate monitors is considerably greater than indicated in the Policy Assessment document , and for that matter, considerably greater than reflected in the ISA; and
we ' ll have data to talk about that if time permits .

Number two , the supporting evidence for the suggestive relationships , we think, is lacking and could be improved .

Number three , in the Policy Assessment document specifically there seems to be an implication in section 3 that globally transported dust from Asia and Africa is coarse material when, in fact , it ' s equally distributed between the fine and
coarse modes , which does affect , I think, how they interpret the health affects data . So I think that1

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should be improved .

Number four , as other speakers have discussed today, we are concerned about the lack of compositional data for coarse PM across the country . We think it ' s quite different and needs to be evaluated .

Number five , we think the change in the coarse standard to the 9 8th percentile three
-year average is premature given the severe lack of coarse data specifically available . Until that data is reviewable , I think it is premature to consider what form that standard should be in .

Going to point number six, standard setting at this time or changing that standard based on insufficient data I think could aggravate already
severe unemployment , which is itself a major health problem that deserves consideration in a standard
-setting process .

Then our seventh point is the effective control strategies of coarse , which is going to be the ultimate direction you go with the standard, will be very difficult given that the dominant sources in many parts of the country, particularly portions of the west and the midwest , are dominated by windblown dust from arid lands , desert areas or unvegetated1

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land, controlled burns and wildfires , unpaved roads , agricultural operations , particularly harvesting and tilling, Asian and African dust storms , which affect both ends of the country, sea salt and pollen . The industrial source contribution is low in many parts of the country, which makes attainment of the standard very difficult . So again , I look beyond just the standard, to the implementation and are you going to be able to achieve what you said, and we have concerns about that issue , as you have heard from other speakers this morning .

Again, in the few minutes I ' ve got left , just quickly on spatial nonuniformity, we found very little data in the ISA, very little , of course , in the Policy Assessment document . We ' ve looked back at the AQS and looked at some coarse data . We can reconstruct more or less from co-located PM10 and PM2 . 5 monitors in various urban areas . When we calculate that data and then compare monitor to monitor in several urban areas , we get something that ' s not especially surprising .

In areas , for example , like Pittsburgh, Los Angeles and Phoenix, when we go and calculate the coefficient of divergence of that data, for example , here ' s the Pittsburgh numbers . We see numbers like1

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-1896 (FAX) 58 point 3 to point 48 , two of the various four monitors
we had to work with in Pittsburgh, which, of course , is not sufficient to cover that area . So for PM for the coarse particulate , we have a coefficient of divergence of point 4 . When we compare that back to PM2 . 5, the equivalent number is point 15 , which highlights the degree of difference in spatial
nonuniformity, and that ' s even before you deploy the monitors which will uncover more spatial
nonuniformity as these monitors go out to other parts of the counties not yet monitored . And it will also get more marked as we get more direct monitors rather than difference monitors that I don ' t think anybody likes especially, so .

DR . SAMET : 30 seconds . DR . RICHARDS : So again, we think the spatial
nonuniformity in the data creates a lot of uncertainty in the epi studies , a lot more than is discussed in the Policy Assessment document and we ' d hope that you ' d consider that , and we appreciate your attention .

DR . SAMET : Okay . Thank you . Questions or comments ?

(No response . ) DR . SAMET : Thank you, Mr . Richards --1

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Dr . Richards . Thank you to all of the public commentors for your input .

Let ' s see , I think this actually brings us 15 minutes ahead to break, so let me make
--

DR . DRECHSLER : Excuse -- did I get missed? DR . STALLWORTH : Is there another public speaker on the phone?

DR . DRECHSLER : Deborah Drechsler from the Air Resources Board .

DR . STALLWORTH . Okay . Our apologies . I didn ' t have your name down .

DR . DRECHSLER : I registered to speak two weeks ago .

DR . STALLWORTH : My apologies . If you want to introduce yourself, then go ahead .

DR . SAMET : Okay . Please , remember five minutes , and please introduce yourself and then go ahead . DR . DEBORAH DRECHSLER :

DR . DRECHSLER : This is Deborah Drechsler from the California Air Resources Board . I thank you for the opportunity to bring the comments of the California Air Resources Board on the proposed ranges for the National Ambient Air Quality Standards for Particulate Matter as were presented in the recently1

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released Policy Assessment associated with the
ongoing review of the National Ambient Air Quality Standards for Particulate Matter . We would like to express our support for the recommended ranges .

We have closely followed the extensive technical work done by U . S . EPA on this review and would like to express our support for U . S . EPA ' s recently implemented framework for judging causality in NAAQS development . This framework provides a clearer perspective on the state of the health science literature as a whole , and thus , the more integrated and transparent basis for the recommended NAAQS . The recommended ranges for both the PM2 . 5 and PM10 standards are supported by the growing body of health science literature , which points to a clear correlation between the adverse health effects and exposure to PM at concentrations which meet or exceed the current NAAQS . In addition, the Integrated Science Assessment indicated that the evidence is now sufficient to conclude that exposure to PM2 . 5 is causally or likely causally associated with mortality, and with cardiovascular and respiratory effects , giving increased urgency to provide adequate protection from PM2 . 5 exposure .1

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U . S . EPA ' s adoption of more stringent standards would avoid thousands of premature deaths in cases of exacerbated cardiovascular disease and asthma . We are pleased to continue our participation in the particulate matter of the standards review process and appreciate the opportunity to comment on the recommended standard .

Thank you . DR . SAMET : Thank you . Any questions or comments ?

(No response . ) DR . SAMET : Okay . Thank you . So we ' ll still , I think, stick with the plan of break until 10 : 30 , so 15 minutes .

Frank, we ' ll be back in 15 minutes . DR . SPEIZER : Okay . I ' ll sign off and get back on .DR . SAMET : Okay . Thanks .

(Recess taken 10 : 14 a . m . - 10 : 33 a . m . ) DR . SAMET : We are back and we ' re going to
move along, then, with our review of the comments in response to the charge
-- charge questions .

Frank, are you back? DR . SPEIZER : Yeah, I ' m back . Can you hear1

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me ? DR . SAMET : Can you hear us okay now?

DR . SPEIZER : Can you hear me? DR . SAMET : I hear you , but do you hear me? DR . SPEIZER : Yes , yeah . DR . SAMET : Okay . Good . Then we ' ll start with Charge Question 1 . Rogene? COMMENTS ON CHARGE QUESTION NO . 1 :

DR . HENDERSON : Yes . This is the charge question that asks what are the Panel ' s views on the staff ' s approach to translating the available epi data and risk and the air quality data into the basis for reaching conclusions on the adequacy of the current standards . My basic answer was the Panel agrees with the approach . I mean, that ' s it in the bottom line .

I was in agreement , and I think others are , with the good overview of the approach that was presented in Figure 2

-1 . I thought that was extremely well done , very clear and included all of the major aspects as ones you consider in judging whether your current standards are adequate . There
are many parts of that we could discuss .

I think it ' s a good idea to go back to the approach used in 19 97 to consider the annual and1

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24

-hour standards together and using the annual standard as a controlling standard and the short
-term standard to supplement the protection afforded by the annual standard .

I think it ' s appropriate that they consider , of course , both evidence

-based and risk

-based information as well as --

UNIDENTIFIED PARTICIPANT ON SPEAKER PHONE : Please speak up .

DR . HENDERSON : -- as well as the uncertainties associated with it .

The second part of that question was that , has the staff appropriately applied this approach in reviewing the adequacy of the current standards and the potential alternative standards .

Well , if you look at Figure 2

- 1 and then you look at the outline of the section 2 . 3 , where they ' re giving these
-- reviewing the adequacy of the current standards , it ' s following that figure exactly; so yes . The answer to both the questions 1 . a and 1 . b , in my opinion, would be yes .

And Frank Speizer is the other reviewer . DR . SAMET : Okay . Frank? Let ' s see , Frank, are you there?

DR . SPEIZER : Yeah, yeah . Are you asking for1

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me ? DR . SAMET : Yeah . It ' s your turn to comment .

DR . SPEIZER : Okay . All right . Well , I would agree with what Rogene said . The only concern that I raised was that
-- this would be more semantic than anything else ; but on page 2

-30 , I thought this language could be even stronger . I mean, it says , calls into question the adequacy; yet the paragraph that follows clearly outlines why indeed the current standard is not adequate .

So I think it ' s well done . It does follow the logic ; and the logic is really, for some reason , a lot easier to read this time around than previously . I think the adding

-- and my memory ' s going now . You know, I ' m getting so old . But I think the putting in of these questions , the rhetorical questions , throughout the chapters are very helpful even though I probably disagreed with that the last time around . I think it makes the logic much easier to follow, and I have to really compliment staff on having really streamlined the data . I think you ' ve done very well . I think it does meet the criteria laid out in the questions perfectly . That ' s all I have to answer .

DR . SAMET : Okay . And I will

-- I will add that I do think the framework that you provided and1

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the adhering to it

-- I mean , it ' s one thing to provide a framework, but it ' s another to actually provide one and adhere to it , which you have done , I think, which leads to a great deal of clarity; and the flow I think is very clear and far clearer than I think we ' ve seen in such documents .

DR . SPEIZER : I ' m only getting about one out of every five words from you . I don ' t know why .

DR . STALLWORTH : Could you mute your line , please ? DR . SAMET : Frank, were you trying to make an additional comment?

DR . SPEIZER : No , I wasn ' t . I ' m just trying to hear you, and I just

-- you kept cutting in and out . DR . SAMET : Okay . Is it just me , Frank, or can you hear
-- are you having the same difficulty with others ?

DR . SPEIZER : No , it ' s just with you . I can hear you now .

UNIDENTIFIED PARTICIPANT ON SPEAKER PHONE : I think there ' s a problem with the line being un-muted . I hear you fine now, but before I was hearing just every other word .

DR . SAMET : So if everybody on can just make1

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sure that your that lines are muted, perhaps that will take care of the issue .

Others who would like to comment on this Charge Question 1 ? Sverre , are you leading up to a comment?

DR . SEVERE : No . DR . SAMET : Okay . Anyone else ? Okay . Then
we ' ll move on . Charge Question 2 , Phil and Helen . Phil ? COMMENTS ON CHARGE QUESTION NO . 2 :

DR . HOPKE : Okay . The issue here is , in the previous standard there was an opportunity to average mass values across all of the measurements in a given
area in order to get a composite value that was then compared to the standard and the recognition that there may be disparities in the concentrations such that a community

-wide air quality measurement may underestimate the exposure in certain areas , particularly those that are likely to be of concern from environmental justice points of view . So therefore , the idea would be that they would now disallow spatial averaging such that the level would be compared to the measurement made at the monitoring site that represents the highest recorded PM2 . 5 concentrations . This is I think quite reasonable in1

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that , obviously, you want to provide adequate protection for all people in a given area and that if people in some areas are exposed to higher concentrations , they are potentially then at higher risk and averaging down those potential concentrations by mixing in lower concentration areas would provide inadequate protection .

My concern or the danger here is that we ' ll regress to the old approach of finding highest values anywhere in urban locations . We used to go hunt for hot spots and find areas that weren ' t on the distributions of population exposures . They might have been on the distributions of industrial exposures , but not on population exposures . And so I think it ' s going to be very important that in the monitoring guidance that comes out with the standard that we in fact mandate that there is in fact a population that is being monitored and not a location .

You know, it ' s perfectly reasonable to protect populations . It ' s not appropriate to protect locations . And so I think taking the highest measured level of exposure as controlling value in order to adequately protect all the population is reasonable , but we ' ve got to avoid reverting to the1

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hot
-spot mentality that was where we were in the ' 7 0 s and ' 8 0s . That ' s going to be finding values which
are inappropriate as a basis for setting up control strategies and protecting public health .

DR . SAMET : Helen? DR . SUH : I don ' t have much to add from what Phil has said . I think it makes sense to eliminate the spatial averaging . I agree with that .

UNIDENTIFIED PARTICIPANT ON SPEAKER PHONE : Please speak up .

DR . SUH : Although not in my comments , but hearing Phil ' s talk, I think it also makes sense to think more closely about the monitor siting issue . So that ' s it .

DR . SAMET : Okay . Thank you . Other comments
on this question? Phil ?

DR . HOPKE : If I can stick a couple more two cents in on the form of the standard . Having been
one of the people who pushed hard for a percentile standard back in the mid ' 80 s , the percentile standard as currently implemented is still a bit peculiar in that you ' re averaging the percentile values in each of the three years in order to get it , rather than looking at the distribution over three years after ensuring there are enough samples in each1

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quarter of the three years to have a sensible distribution .

It really would make a lot more sense to just look at the overall distribution over three years rather than looking at individual one-year distributions , at least until we get to the point of having adequate data . I mean, it still comes back to the lack of monitoring system that provides adequate data since we ' re only monitoring every third day .

DR . LIPPMANN : At best . DR . HOPKE : At best . You know, we really need in this round of standard setting to get off filters and onto continuous monitors and have the data so that we can in fact have adequate statistical bases for making determinations of attainment or non-attainment of the standard and adequate data to actually assess health outcomes , and I think it ' s time we stop fooling around with filters and get on with it .DR . SAMET : Mort?

DR . LIPPMANN : I agree , and I think everybody who ' s written comments agrees that
-- get past spatial averaging . But is it something that ought to be said in that context in that it relates to margin of safety? Margin of safety is an issue that keeps1

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-1896 (FAX) 70 coming up and we never quite come to grips with it in terms of satisfying ourselves or the Agency or the public that it ' s being dealt with; but every place where in fact the margin of safety is being introduced, it should be noted . And in fact , getting away from spatial averaging adds some margin of safety for some population .

DR . SAMET : Other comments on this ? I want to go back to Phil ' s comment re : monitor location versus population average . So it
seems to me this is an important point that we may not have discussed enough, which is trying to represent a population, the population ' s distribution of exposure , and do the existing monitors do that for PM in a way that is informative . I mean, we actually have a historically located set of monitors perhaps of uncertain representativeness .

So Phil , I think your point in general is probably well taken and speaks to an ideal ; but what about the actual and where we are now, which I think is what you ' re speaking to in part .

DR . HOPKE : Right . I mean , again , the mandate starting with the ' 97 standard was to provide population

-exposure-based monitoring; and with the number of monitors that were mandated plus the1

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-1896 (FAX) 71 replicates and that sort of thing, there probably
were adequate numbers of monitors covering most populations in most urban areas .

Now, as we have identified attainment , non-attainment , and some of the other things , everybody has pulled back monitors . And now if we start to re-look at how we ' re going to deploy that monitoring network with a new set of guidance , which is not going to look at community

-wide averaging, but look at the highest value within that community, all I ' m suggesting is that we want to make sure that we don ' t -- that we ' re still looking at population monitoring, not hot
-spot monitoring in the network, in that community where people
-- where there is not
a significant population .

DR . MARTIN : Can I just provide just some -- mic on -- some clarification of the intent . The current standard is

-- the current 24

-hour and annual PM2 . 5 standards are implemented in that the annual standard is compared against concentrations measured at monitors that represent community

-wide spatial scales . They are not hot
-spot monitors . They ' re community

-wide spatial scales . 24

-hour standard is compared against monitors at a more localized scale , more consistent with the purpose of the peak1

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exposures . And our intent here would be to continue that same approach, that you wouldn ' t use a , quote ,

"hot
-spot" monitor to compare against the level of the annual standard for the sake of determining attainment . That wouldn ' t be consistent with the way in which the standard was developed and the purpose of the standard, to capture community

-wide population exposures . So what you ' re saying is what the current monitoring requirements say and what we would intend them to continue to say .

DR . SAMET : Okay . Mort? DR . LIPPMANN : Making it a more generic issue , I agree with the discussion; but we ' re going to come to it later with the thoracic coarse particles and at
some point down the road with ultrafine particles and monitoring strategy becomes extremely important , and I don ' t think it ' s explicitly addressed sufficiently in the document in both Chapters 2 and 3 .

DR . SAMET : Okay . Ted? DR . RUSSELL : So Karen -- DR . SPEIZER : This is Frank
-- DR . RUSSELL : -- help clear something up in terms of what you just said in my mind . So you would have one set of monitors that you would consider hot
-spot monitors that would not be used for annual1

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average attainment demonstration or attainment

-- yeah, attainment demonstration .

DR . MARTIN : And that ' s the way it ' s currently done . Monitors are described in part by the spatial scale that that monitoring location represents . So
we distinguish between community

-wide , which is a much broader spatial scale , and more localized spatial scales . And the monitoring requirements are such that one does not compare the more localized spatial scale , the more hot
-spot monitor to the level of the annual standard for the sake of determining compliance . That ' s the way it is now . That ' s the way we would intend to continue it . I agree that this document doesn ' t speak sufficiently to that point , and we can certainly add that quali

-- that clarification into the final document .

DR . SAMET : Tom? DR . SPEIZER : John, this is Frank . DR . SAMET : Frank, hang on one second . DR . SPEIZER : The discussion

-- DR . SAMET : Okay . DR . SPEIZER : -- confirms what I put in my notes . I think what ' s needed here is a footnote defining what ' s meant by community

-wide monitors . It ' s not clear in the document what that means . And1

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I think the clarification of that will go a long way to understanding that we ' re not talking about the hot spots , but we ' re talking about something that ' s representative of the community and, presumably, either long
-range or community

-wide exposure . So I think a footnote would solve that problem .

DR . SAMET : Okay . Tom? MR . MOORE : So this actually takes me back to 1996 when Phil and others were advocating for the percentile form, which I think is a good idea . But the point that Phil makes about looking at the distribution over whatever the compliance time of the standard is , is important when you have wintertime episodes because if they happen across the end of the year , they get segregated into two different data sets for the purposes of calculating the percentile , and you really want to look for both the 24

-hour and the annual at the whole distribution over that period because that ' s the period you ' re establishing compliance and health protection steps for . So rather than have this arbitrary thing where data only exists in a certain year, it ' s really a three
-year compliance form . We should look at the whole distribution during that time period . This leads to situations where you can have very low ambient1

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concentrations many days and then you get one peak episode and it happens to fall across the end of the year , that area meets the standards , but in fact is

-- has a very unhealthy episode . I can send you some data that does this calculation , so .

DR . SAMET : Helen? DR . SUH : Just a clarification question again . So for the 24

-hour standard, though, do you consider the hot
-spot monitors for the 24 hours ?

DR . MARTIN : Yes . We consider them as monitors that represent smaller, more localized spatial scale in conjunction with comparing them to the 24

-hour standard .

DR . SUH : So then , does every community have the hot
-spot monitors ? I ' m guess I ' m trying to figure out about this proportion

-- going back to what John had said

-- about the proportions of hot
-spot monitors that occur . Is it a requirement for every city to have one or every large MSA or community? Because I ' m wondering if that sets up the differential protection for the 24

-hour basis .

DR . MARTIN : Requirements relate to minimum monitoring requirements to monitor the highest concentration at the appropriate spatial scale as defined as part of the requirements set out in1

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-1896 (FAX) 76 conjunction with the standard itself , so that we ' re recognizing that there are different spatial scales that are relevant . Minimum requirements focus on monitoring the location where you would expect the highest concentration to occur at the appropriate spatial scale , if that answers your question .

DR . SUH : You know, I think it ' s really more a question , not so much, I think, how you guys decide and define it . It ' s really more a question of where the monitors are placed now to determine the component --

DR . MARTIN : What I ' m describing is the monitoring requirements that have been in place in conjunction with the past standards
-- the current standards , and so that ' s the direction for the current network; and we ' re not envisioning a change in that aspect of the monitoring requirements .

DR . SUH : Okay . Thanks . DR . SAMET : And the question of the number of population

-oriented versus local , it seems -- hot spot , it seems to me that the balance is far more population than hot spot or a locally source oriented; is that correct?

MS . HASSETT-SIPPLE : I don ' t know the specific
answer to that question , Dr . Samet . But in the1

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-1896 (FAX) 77 preliminary draft Policy Assessment , where we provided much more detailed information on air quality and the monitoring network, has that information . We ' ll go back and bring some of that forward in the final .

DR . MARTIN : We obviously have monitoring experts who know the answers to those questions . I don ' t have the specific answer .

DR . SAMET : It might be good just if we could refresh our memories while we ' re here today . I think that would be helpful and just try and understand exactly what we ' re talking about . At least my recollection is that in working with these data in
our NMMAPS and others said that most monitors are coded as , quote , "population oriented" and not sort of source oriented . So it would be useful to know exactly what we ' re talking about .

DR . MARTIN : Okay . DR . SAMET : Let ' s see , other comments on this
one? And let me circle back then to Phil and Helen and see , just to summarize , sort of, your bottom
-line positions on this .

DR . HOPKE : I mean, the bottom line is that what they ' re proposing, I think, is reasonable within , as I say, a framework of just making sure1

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that when they ' re putting the guidance together that they ' re careful in making sure that overly zealous local air quality managers are not going out to try and find the hot spots . As I say, that that was the approach that was taken in the early days of the game ; and, you know, those are not exposures to populations . Those are exposures -- those may represent exposures to the workers working in those hot spots . So just , we need to make sure we ' re careful in making measurements that , in fact , are relevant to public health .

DR . SAMET : Good . Any other comments ? DR . SPEIZER : Can I make a counter argument there a little bit , because it seems to me that hot spots are , not only the workers ' exposures , but they ' re the gate , sort of, the margin of the gate exposure as well ; and whether or not you ' re at the gate , they ' re getting the hot
-spot exposure . There ' s a difference between monitoring that for purposes of control of exposure to a select part of the population and a community

-wide estimate of what the exposure is for the population in general . So I think the two kinds of measurements serve different purposes and it ' s just a matter of what ' s being used to measure compliance in two different settings ; one ,1

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industrial sources versus community

-wide exposure . So I think we can ' t pick one over the other where the implementation needs to go . Both are used .

DR . BRAIN : This is Joe brain . I agree with Frank . It seems to me often poor people live near these hot spots . I mean, that ' s very, very common along roadways or in port areas where there are lots of diesel trucks or the busses are idling . So I
mean , it ' s hard for me to think of hot spots in urban centers where there aren ' t usually lots of people living nearby .

DR . SAMET : So we ' re going to come back to this issue . I think also the question is spatial heterogeneity, really, when we talk about the coarse . I think when we do that , it would be useful , maybe , if we just had in hand a little bit more information about exactly the distribution of monitor types and
so on . So , I think, why don ' t we move to Charge Question 3 , which has six parts and a lot of, sort of , meat to these questions . What I think we probably ought to do is do them A, B , C , D, E , F, and go through them one by one .

So let ' s see , Mort , you ' re in the lead on this .1

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COMMENTS ON CHARGE QUESTION NO . 3 :

DR . LIPPMANN : I don ' t have any significant comments until we get to F . I thought the staff did
an outstanding job of addressing each of these points that they were asking for clarification on, recognizing, as we always must , that they ' re limited by available information, that they ' ve examined it carefully and made appropriate judgments . And the only thing I would comment on is the last point , that is the F, the conclusion that they draw . There I have some differences of opinion .

DR . SAMET : Okay . So why don ' t we spend some time on the , sort of, the technical aspects , particularly A . I understand, Karen , this is the point where you wanted to comment?

DR . MARTIN : Right . As I alluded to in my opening remarks , we have done further thinking on this particular issue that ' s identified in 3 . a . i about confidence bounds on concentration

-response relationships . As you recall , it was a discussion of this committee on the first draft . We have
-- we presented what we considered to be something we focussed on a great deal recognizing the importance of it . We enlisted the support of our colleagues in NCEA who developed the Integrated Science Assessment1

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to help us search for studies that might provide information on confidence intervals around concentration

-response functions . And we consider

-- based on what we consider to be a thorough search, we identified the three studies that we discuss here .

Upon reading Dr . Vedal ' s specific comments on this point and his concern with how we address them, we contacted key investigators from those three studies to better understand what they did and their views on what they did . And I just wanted to take a couple minutes and talk through how our thinking has evolved based on that kind of revisiting of this issue . I think there ' s general agreement by everyone that these confidence intervals are intrinsically related to the issue of data density, that
uncertainties increase in some measure with distance from the mean of the distribution or the reference point you ' re using to explore the distribution . The question then becomes what more can they tell us beyond what distributional statistics might tell us , and I think that ' s sort of the heart of this issue here . In looking first at the Pope 2002 study, which Beth has put up here , we talked specifically to Rick1

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Burnett about this , who did these confidence interval analyses . And basically, his view of them was that the analyses were done for the purpose of exploring whether or not they could identify major departures from linearity in the models being looked at . They concluded that there were not clear departures from linearity based on the assessments presented here and, further , that it wasn ' t clear to him how one would use the point

-wise confidence intervals around the distribution to make inferences about the underlying true concentration

-response model without doing more analyses . And one of the things he alluded to was , perhaps , model averaging .

Bayesian

-model averaging would be one approach that would allow one to explore more fully the question , the more fundamental question , of are these
-- whether the confidence associated with our view of the existence of the relationship continuing down to the lower ranges of the air quality distribution , that while one can look at confidence intervals around the estimates of the mean at each point across the air quality distribution , and you can have some confidence about or knowledge about the
uncertainty associated with the degree of risk that you would estimate across that distribution , that ' s a1

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different matter from having confidence about the existence of the relationship continuing down through the full range of air quality in the study .

We then talked with Joel Schwartz about the second of the three studies we looked at , the Schwartz , et al . , 2008 study . And in particular, we pulled one specific figure from that study, and that ' s the figure you see here . This figure in his view was clearly a point

-wise confidence in the effect estimates associated with each concentration along the distribution, that it didn ' t speak to an investigation of thresholds . However, he pointed out in the same paper that they had done a Bayesian

-modeled average analysis .

This Figure 2 that you see here is a figure that we did not include in the second draft but is a figure that he pointed us to as being a figure that reflects , as I said, Bayesian

-model averaging across 32 models . Some of those models had options for thresholds as low as 10 micrograms per cubic meter .

The conclusion of the analysis was that the assessment clearly chose a linear fit below 10 . There was no evidence of a threshold, but the observation is that the confidence intervals widen from 10 and below . The interpretation of this in our1

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view, based on the discussions we have had, more closely represents something that informs the most fundamental question about our confidence in the continuation of the existence of a relationship
across the range of air quality in the studies . In this case , however, even in light of the widening of the confidence range toward the lower end
-- and we would note that the lower end of the range of air quality in this study was eight . So that when you get down to ten , you ' re clearly in the low part of that distribution .

For example , one standard deviation around the
mean of this is 10 . 7 . So if you look at the standard deviation below the mean, it ' s 10 . 7 in this analysis . So that again, this is telling us in part that we have less certainty where we have less data , but it is also reflecting confidence around the modeling averaging across models . And from the investigators ' view and from ours , that seems to provide the kind of evidence that more closely gets to what the fundamental question is we ' re looking to address .

Let me just speak to the third study that we identified, and that ' s the Miller, et al . study . And here again , the emphasis from authors of the study
was on the purpose of the study, was to explore1

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non-linearities . The analyses provided no evidence of a threshold, no evidence that what we were seeing
was the suggestion of a threshold from these analyses ; and the encouragement we received was to focus more on that aspect of the analysis .

It is also the case in this particular analysis that the program that they used to run this assessment required the specification of a reference value . The reference value the authors selected was a concentration of 11 . Concentration of 11 , based on the information in their paper is a concentration that is at the low end of the second quintile , i . e . , roughly in the 2 1 st percentile of their distribution and that the program necessarily results in the tightest confidence bounds around that reference value . So in essence , this is an analysis that looks at the relative differences of slopes and confidence relative to a preselected reference point .

So from that perspective , we continue to interpret this as telling us something about the likelihood of thresholds across this range of air quality, but especially in this case because of the selection of a reference value it ' s hard to interpret the widening of the confidence intervals using the absolute values of the concentrations where those1

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intervals widen in this curve because it is necessarily a consequence of the selection of that reference value .

I would note that , as I said, that this concentration of 11 is about just above the 20th percentile of the distribution . One standard deviation below the mean of this air quality distribution is 10 . 2 .

So in revisiting this issue , we ' re very much interested, obviously, in hearing your discussion of these points ; but we wanted to put on the table here the further insights that we got from these discussions , our further thinking . From our perspective right now in revising this section, we would definitely include the second figure from the Schwartz study and highlight that as an approach that potentially speaks most directly to the most fundamental question . I think we would interpret the other analyses as not being inconsistent with what we gained by looking at the air quality metrics that
were the distributional statistics from a broader array of studies that we can identify those kind of statistics from .

So having said that , unless there are any questions , I ' ll stop and let you all discuss the1

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-1896 (FAX) 87 points . DR . SAMET : Okay . Thank you . That was very helpful . I think the issue of the model uncertainty
versus the distribution of the estimates at points along the curve is an important distinction for us to keep in mind .

Let ' s see , Rogene , and then we ' ll go back to Sverre . DR . HENDERSON : I have a question . In a linear and no threshold model , how do you handle the margin of safety part of the Clean Air Act? I mean, it bothers me that if there ' s no threshold, how can you have a margin of safety?

DR . MARTIN : Well , just because there is no discernable threshold doesn ' t mean that we don ' t have less confidence in understanding the nature of the relationship as we get to lower concentrations . So the question about where do we have decrease in confidence is certainly a salient one to help answer the bottom
-line policy question that you ' re posing, but there are different kinds of evidence that have different kinds of uncertainties and weighing those
uncertainties against the results of these analyses is fundamentally how we always have to deal with that issue .1

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DR . SAMET : Okay . Sverre , I think you ' re next up . DR . VEDAL : Yeah, thanks . So I guess I could have commented even on the first current approach, but it ' s probably reasonable to start the discussion on the
-- on the discussion of the level .

So I was happy to see that staff had introduced this aspect of a way to translate epi findings into

-- to provide insight into standards based on the earlier discussions , and so I have several issues that that brought up .

The first one I think you addressed, which is that there was no indication from what was presented how thorough or comprehensive that selection of studies was ; and I understand from what I ' m hearing from you that that ' s what ' s out there . I ' m not sure that ' s true . I don ' t have the resources that you have to do that , but I expect that ' s right .

DR . MARTIN : We identified studies using PM10 . DR . VEDAL : Yeah . DR . MARTIN : We identified studies using
ozone . DR . VEDAL : Yeah .

DR . MARTIN : In talking to other
-- the investigators in these studies , some said, well , I1

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think there ' s more out there ; but I don ' t know for
sure what pollutants they ' re looking at . So all I
can say is based on what we consider to be a thorough exploration here , we conclude these are the three studies that provide this information .

DR . VEDAL : And I think that ' s -- DR . MARTIN : If anyone has any other examples , we absolutely welcome having them identified .

DR . VEDAL : I thought there was one from another, Peters and others , but I ' ll have to try to put my hands on it . But that ' s -- that ' s fair enough . The primary issue was I think where you spent most of your energy during this presentation addressing is really how to interpret those so-called confidence bounds on the concentration

-response function . And I was particularly just troubled by the statement in the Policy Assessment which was that these analyses do not provide evidence of a concentration below which the confidence interval becomes noticeably wider and uncertainty in a concentration

-response relationship substantially increases . So I took issue with that statement because I think they do provide information about that , and provide insight into that .1

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I appreciate the arguments that are being made here about point

-wise uncertainty, whether the intent is to address linearity as opposed to that issue of
uncertainty . Personally, I think the issue of linearity and uncertainty are inextricably intertwined . If you ' re trying to determine whether there ' s a threshold there , that is

-- you know, the information that you ' re using to determine that is exactly the issue of how uncertain that relationship is . So at the end of the day what are we left with? We ' re left with very, very little information to make use of that . And I understand why one might want to just discard it all together just on the basis of there not being very much information there . I take issue with just tossing it completely because of the arguments that it provides no insight into this uncertainty . I think it provides a lot of insight into the uncertainty .

The issue at the bottom of this is how we make
use of epidemiologic findings for the purposes of standard setting . And I would argue that what we would like is , in the epidemiologic studies , where in the concentration distribution is the oomph of a study? You don ' t find that
-- you don ' t find that1

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information by looking at the concentration distribution ; right ? So you ' d like to have
-- where is the oomph along that distribution in terms of producing the findings that are being produced in this study? All right . We don ' t have that .

So the next effort is then , well , what is the link between the concentrations in the study and the population sample ; how does that link up? There is a distribution there , and it isn ' t consistent or continuous or constant along the entire distribution of concentrations that you have .

In a time series study, it doesn ' t matter because generally they ' re the same number of deaths
or events on any given day and that distribution of exposures of people probably pretty much closely corresponds to the distribution of concentrations that are being displayed .

I think in a cohort study that ' s not the case . You have monitors that monitor concentrations over space ; and what is the link, then, between those concentrations and what the concentrations are that the study population

-- that link? And if you notice in that bottom part of the Miller paper , there was an attempt to do that . They show that little

-- well , they call it histogram, but it ' s really a density1

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distribution of the population by concentration ; and there you get some insight into how those concentrations link up with the exposures in the population . Now, that still doesn ' t get at the issue about what concentrations actually are important for the effect estimates , but it ' s better than just looking at the distribution of concentrations , however those are monitored .

If you don ' t have information on the linkage between the concentrations and the concentrations of the population, then you ' re left with having to do what you ' ve done , which is basically take the concentrations that are available in a study and then do something about the distribution of those concentrations and argue that those have relevance with respect to the health effects that are observed, and that may or may not be the case depending on just the issues that I touched on . You don ' t know where along that concentration distribution the oomph is , nor where the links are with the population sample of that study . So that ' s basically where I stand . At the end of the day you ' re left making a lot of recommendations about the standard on a method that is a very indirect way of getting at what we really want to get at . So I mean , that ' s basically my whole1

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issue . And you know, we ' re now talking about concentrations that are for consideration , particularly the annual standard, that are lower than what were in our, sort of, window earlier , all based
on these distributional arguments .

DR . SAMET : So Sverre , as usual , you were not crystal clear .

(Laughter ) DR . SAMET : Just to try and capture this a little bit more -- and I think this has to do really with how these considerations relate to the determinations of what levels might be appropriate . Let ' s go back to your comments a minute and then I think go to Chris .

I got a little off on this new technical term you had introduced, oomph, which I think might refer to the distribution of population exposure time and also captures within that the ranges of exposure , which events are occurring, which in part we lack .

And I think the other issue that
-- I think there are two issues , sort of, that are now concatenated . One is what is the nature of the exposure-response relationship at lower levels and, then , what are the confidence bounds around some modelled relationship . I think these are all1

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considerations related to the confidence one has at lower levels and I think this particularly relates to the cohort study . So I don ' t know, have I captured this in some -- the issues in some way?

DR . VEDAL : I don ' t know . I thought I was clear . But you know, the oomph issue is , even though you have a population and you have this linkage between the concentrations and the population , you don ' t know where along that distribution what is the , sort of
-- I don ' t even know how to describe it , where the information that actually goes into influencing the effect estimate .

DR . SAMET : So I think that ' s what I said, where the events are and where the population exposure time is .

DR . VEDAL : Yeah . Now, attempts have been done to do
-- one way of getting at it , and it ' s sort of
-- it comes from sort of a time series world, is where people have basically artificially chopped off upper ends of the distribution and seen if the effects still continued as they go lower and lower and lower . That ' s one way of, kind of, getting at that question . But there ' s nothing that we see in anything presented that would provide that type of1

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-1896 (FAX) 95 insight .DR . SAMET : Chris ?

DR . FREY : I ' m not sure I have a lot to add to what ' s already been said . I kind of struggled with this section on the confidence intervals because , just as a reader, it wasn ' t that clear what the purpose was or some of the judgments made were , I think, not expressed very clearly . So some of my comments are more editorial , and I don ' t think it ' s necessary to go into those in a lot of detail here .

I guess what I ' m still struggling with is I guess it seems like there ' s maybe a couple of main ideas . One is the idea that the epidemiological studies are based on observed air quality and effects that are really only valid for that range of observed air quality, and then there ' s other issues that Sverre mentioned in interpreting that . And so that
one would be uncomfortable extrapolating the concentration

-response functions to very low average air quality because that ' s not part of the observation in the epi studies . And maybe that point , if that ' s what one of the issues is , could be made more clearly as a key motivation for what this section ' s about .

And then another part seems to be what is the1

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confidence interval and the concentration

-response relationship at a given value of air quality and how does that confidence interval change with different values of air quality . I think what I would have expected to see in a section like this

-- and I think it ' s talked about later but maybe belongs in this section

-- you know, is there sort of a bottom
-line judgment as to what effects are statistically significant at what concentration levels and at what concentration levels , as you go lower, are the effects no longer statistically significant but still positive . And I also think that , just given the statutory mandate of the NAAQS , which is to allow an adequate margin of safety requisite to protect the public health, that the focus shouldn ' t be just on , say, the lower end of the confidence interval , but also on the higher end; and I didn ' t really feel like that was addressed at all .

So those are just some general comments . I have , as I mentioned, more kind of editorial comments , but maybe that ' s enough for now .

DR . SAMET : Mort , back to you . DR . LIPPMANN : I want to get back to the last item, section F, which takes all the knowledge we have and all the uncertainties that remain and come1

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up with some judgment on what ' s necessary . But if there ' s any discussion on anything before that perhaps people should speak .

DR . SAMET : Well , I think we need to come to a little more useful guidance , perhaps , here . In a way, I think one issue is what is the relationship between the decisions made under A and what judgments
are offered around F . And I think this has to do with the interpretation of uncertainty and how confident one might be in proposing that 13 , 12 , 11 , or some other value is appropriate , or that reaching down to the lower end begins to exceed the bounds of what we actually know . And I think what we ' re saying is we know less as we go down one way or another . We ' re talking about a relatively narrow range , which I think is also probably important to remember .

So let me ask first , does anybody else want to comment on issue A, which is the
-- the confidence bound statistical metrics , the work that EPA has done in going back to the studies and obtained data from investigators .

Chris ? DR . FREY : Yeah, I guess I just want to add, I had some discomfort with the tone of the section because I guess the way each section ' s written it ' s1

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almost like we ' re only going to look at this information and then decide on levels that should be looked at . And I sort of don ' t think that , you know, part A, sub i , is a sufficient basis to choose levels . I think it provides information that informs that choice . For example , to look at the air quality concentration distributions and say we ' re going to look at the 10th to 25th percentile , to me that ' s not
a reason to choose a level by itself ; but it needs to be coupled with, well , what ' s the evidence of health effects . And I think it also needs to be coupled with some of the things mentioned, I think, even earlier in the chapter on what are the potential biases in concentration

-response relationships , what ' s not accounted for, things like the socioeconomic status .

So maybe it ' s an artifact of the way the chapter is organized, but it almost seems like it ' s trying to convey that , oh, this should be sufficient
reason to choose levels ; and I think it sort of is
unconvincing to me as a reader because of that .

DR . SAMET : Sverre? DR . MARTIN : If I could offer a clarification
on that point . Our goal was quite the opposite . Our goal , as stated up front , was to say we recognize1

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there ' s no one right way to interpret epi to translate it into a standard . We are going to look at alternative approaches and collectively look at what we think they told us . Some approaches build on more information . Other approaches have more limited information to inform them . But I think in the end, our view would be all have some value and we need to look at it all together . And by laying it out the way we did, we tried to take one piece at a time , not to reach a conclusion that any one piece is the right piece to use , but rather just a more orderly process of working through it . And if that didn ' t come through clearly we can certainly revisit how we introduce this to make that clear .

DR . SAMET : That introduction might help because I think this is difficult and challenging text . Sverre ?

DR . VEDAL : Yeah . No , I -- and what Karen Martin just said, I think that is a useful perspective and one that I don ' t think comes through here . What I read from this is that , you know, the concentration

-response functions just are not useful for this purpose and we ' re not going to use them .

DR . MARTIN : That was --1

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DR . VEDAL : Instead, it should be something to say we should encourage further work along these lines and for people that present data along these lines so that they are useful for that purpose . But I think what you said here at the end is good, that you are actually integrating all things to look for consistency to support the arguments .

DR . SAMET : Does anybody else want to weigh in
on A? DR . SPEIZER : This is Frank . I was impressed, if you look at page 2

-59 , the series of three figures that they represent -- I think they represent different

-- modestly different approaches and they all at least tell me the same gut story, which is that until you get down to about 12 micrograms things
are pretty tight ; and it ' s below that level that the confidence intervals get larger . And it seems to me that that was a pretty consistent story and might make for a benchmark to use as sort of what are we looking for here . What are we looking for in terms of being able to , sort of, pick a margin safety or begin to think about the uncertainty slightly differently .

I think it ' s a pretty simple

-minded approach . It ' s not statistical , I suppose , once you look at1

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these figures . But it says to me that down to 12 you can be pretty confident you ' ve got results and then the question becomes the Policy Assessment of comparing both margin of safety and uncertainty below that level .

Now, I guess with the added information that Karen has brought in, I ' m not sure it doesn ' t support that even further in terms of sort of picking the way of going at this .

DR . VEDAL : Yeah, I thought these examples presented different approaches to qualitatively try to do the same thing . I mean, obviously, the WHI one was quite different because of their reliance on a reference point , which kind of was a little weird . It already presupposed in some sense something, which seemed to be one shouldn ' t presuppose . But basically, they were different types of methods used to try to qualitatively get at the same issue .

DR . SAMET : So I think maybe when we get to F, I think this will come back again in terms of
-- and I think Mort keeps reminding us of this

-- it ' s really the bottom line here in how the uncertainty figures in that will be important .

So why don ' t we leave A, which we might possibly talk about at greater length without saying1

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-1896 (FAX) 102 anything any more useful , and move on to B, which is potential alternative annual standard levels based on composite monitor distributions

--

DR . VEDAL : Did you forget little

-- DR . SAMET : What? Dr . Vedal : Number ii , A . ii ? DR . SAMET . Okay . A . ii . Okay . Anything A . ii

-ish?

Sverre ? DR . VEDAL : Minor things , I think, in addition to what we ' ve talked about before .

Now we ' re in the world of trying to use the concentration distributions and then trying to say something useful about the concentration distributions for setting standards . There ' s already been alluded to some issues . I think Phil mentioned something about terms like , just somewhat below, those sorts of kind of loose terms , like just somewhat below the mean or substantially below the
mean , whatever that means . And then this

-- I don ' t
even know quite what this was about , this issue of trying to support use of a standard deviation versus percentiles because it ' s a more robust measure across the , you know, the various studies . I didn ' t understand that at all . I kind of like the1

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-1896 (FAX) 103 percentile approach because it translates nicely into
some potential sensitivity analyses you can do or different scenarios you can explore . But so , that ' s all the substance of my comments on that part .

DR . SAMET : Chris ? DR . FREY : Yeah, I agree with that comment . I think one standard deviation is arbitrary . I would have been happy to see 10th percentile , is equally arbitrary, but it

-- I don ' t know . And you know, if it ' s one standard deviation, well , why not 1 . 65 or 1 . 96 standard deviate . It wasn ' t that clear if there
was some reasoning for that .

Let ' s see , I think I had one other comment . Yeah . Well , this one is sort of like my earlier comment . It seemed like this part was focussing on the concentration distributions irrespective of health effects , and I guess this is looking at the domain of concentrations that underlies the epidemiological estimates and it ' s sort of looking at , well , we don ' t -- I guess the idea is that you ' d rather not extrapolate beyond that domain of air quality concentrations . Maybe that point could be made a little more clearly to motivate that particular section . That ' s it .

DR . SAMET : Okay . Let ' s move -- I think let ' s1

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-1896 (FAX) 104 spend a little bit of time separately on -- at least B and C, D and F kind of run together . But comments
on B? We ' ve touched on this a little bit already .

DR . VEDAL : Yeah, we have touched on it already . I really
-- I understand the argument about margin of safety, I think . What I don ' t understand is basing it on this is what ' s used in the epi studies versus the form of the standard . I don ' t know what should take precedent there , but it wasn ' t clear to me that just because they were used as metrics in the epi studies that had any sort of a credibility as an argument . Also , when we start talking about the coarse standard, this argument doesn ' t rear its head at all . We ' re just entirely in the world of 98th percentile .

DR . SAMET : Phil ? DR . HOPKE : Yeah . I ' m not quite sure how we have a question here because it seems to me that the level of the standard has to be based on what our considerations are for the health effects at a given concentration . And if we ' re measuring those concentrations in an area for which a population is exposed then those people have to be protected . So I ' m not quite sure what the issue is here . We certainly don ' t want to adjust the level of the1

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standard because we ' re making higher measurements at
some location where there ' s an exposed population . So it seems to me that
-- I ' m not quite sure how these two are interlinked particularly . Other natures of the form of the standard, like the statistical form, then there ' s clearly some important links . Here , the main thing we ' re trying to decide is what is the basis for protecting public health by making measurements of the exposure of a population . It seems to me that once you ' ve found a population that is exposed at a given level , the question is , are they protected by the standard or not , and set the standard based on the estimated health effects at
a given

-- at given concentrations .

DR . SAMET : Okay . Any other comments on -- DR . MARTIN : If I could ask a clarifying question on this point , the comment about once you ' ve identified a level at which effects are seen in a study, then you want to protect against that level . Of course , the level in the studies is characterized by an air quality statistic that is arrived at by averaging across monitors . It is not arrived at by looking at the monitor in each of those cities at a community

-wide spatial scale that had the highest1

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level . So we ' re sort of comparing apples and oranges when you then apply the level of the standard at the highest appropriately sited spatial scale monitor . So the discussion about composite versus max monitor is to recognize that in these studies where we ' ve identified effects , we commonly characterized the air quality in the study by the mean of the distribution based on averaging across monitors , not based on the highest reading monitors in

--

DR . HOPKE : In a lot of studies

-- DR . MARTIN : There has to be
some translation

--

DR . HOPKE : -- but not in all , you have things like the Jerrett study where you relate things back to the nearest actual monitor value ; so there are some data that are out there and, in fact , that raises the risk estimates . So it seems to me that this approach still provides , as Mort had indicated, that additional margin of safety that is worth including although it may not be quantitatively characterizable .

DR . MARTIN : And that was the point we were making in terms of if you were to use the composite monitor

-based concentration that is reported in the studies and then you set a standard to protect1

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-1896 (FAX) 107 against that level and apply that standard at the highest community

-wide monitor , you are building in a margin of safety; and that was one of the points we were trying to make in this discussion .

Another way to do it , is to look and investigate , which we did, what were the concentrations in the highest monitors that were occurring at the time of the study and then think about if you were to use those concentrations how would you then build in a margin of safety when you set a standard based on the highest monitor .

So either way you do it , there ' s sort of a mismatch between the averaged concentrations in the study and applying it , comparing it to the highest monitor in an area . And you can do it either way with either set of air quality statistics in the studies , but they represent a different comparison and the margin of safety considerations are then different . And that was the purpose of that discussion , looking at the two different types of air quality characterizations .

DR . VEDAL : Right , and I think we understood that . Just to echo in further Phil ' s comments about city averages and such, I mean , even the WHI study1

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there , a lot of their oomph was based on, within the city, nearest-monitor comparison . So even in studies that are being used in this version have used not city

-wide averages . And certainly future studies are all going to be like that , try to make use of within city differences in concentrations rather than the city

-wide mean .

DR . SAMET : Thank you . Let me point out , we ' ve been joined by Kathleen Weathers . Welcome .

Let ' s see , other comments ? Because what I ' m going to suggest is that maybe we go to , sort of, C through F together and go over the proposals around numbers , the confidence in those numbers and so on . This has to do with, really, I think, much of what ' s contained within C through F .

Chris ? DR . FREY : Yes . Just on B , before we go . There ' s , I guess , on page 2

-73 , there ' s discussion about ratio between the 24

-hour air quality concentrations and the annual concentrations , and there ' s some nice figures . I like the figures that follow that , but there seems to be a conclusion based
on the figures that it ' s reasonable to focus on a 24

-hour standard level that is 25 times -- or at least 2 . 5 times higher than the annual standard level1

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and, therefore , it ' s appropriate to retain the 35 microgram standard . I thought that was a very strong conclusion that wasn ' t really supported by what ' s presented there .

I think what those figures show is there ' s some relationship between the 24

-hour and the annual concentrations and that , maybe , on average the ratio is 2 . 5 ; but from a health effects perspective , I really didn ' t understand why 2 . 5 was a magic number . And this also goes to , I guess , the notion of whether the annual standard should be generally controlling . And maybe
-- I wasn ' t here for the last meeting so I may have missed some of the discussion on that . But just as a reader, it doesn ' t seem consistent to -- or maybe it ' s just not realistic that that ' s going to be the case everywhere , and I think that ' s pointed out throughout the document , that some places the 24

-hour standard probably is going to be controlled as opposed to the annual standard . So I ' m not sure why it ' s necessary to say that , but maybe that ' s a bigger question than just part B .

But I think the conclusion here on page 2

-7 3 , I think it really doesn ' t belong there . Maybe it could be interpreted in some other way, but not as strongly as how it ' s presented here .1

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DR . SAMET : I guess this comes up in this peak
-to-mean and peakiness stuff , which is sort of like oomph .

DR . FREY : Well , maybe just one other minor thing, if the 2 . 5 is applied, there ' s a math error in here , I think, or just something overlooked, that if you multiply 11 by 2 . 5 it ' s 27 , not 35 . So even that statement is not consistent .

DR . SAMET : It ' s plus 2 . 5 was my interpretation .

DR . VEDAL : Yeah . DR . SAMET : Was it a multiplier? DR . VEDAL : Yeah, so just on another point that Chris mentioned, this issue of
-- it seemed to
me the argument was about the annual standard in light of the 24

-hour standard was in order to maintain the annual standard as the controlling standard, if we use this 24

-hour standard, we better
use an annual standard of such
-and
-such . I don ' t see that at all .

DR . SAMET : Actually, I think this really takes us into the general discussion . Let ' s go back to Mort .DR . LIPPMANN : The issue was , you know, the reasonableness of the recommendation . I thought they1

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were reasonable in relation to the criteria established by the Clean Air Act , those developed which we reviewed in this process ; and you know, it ' s been reasonable .

I approach this , personally, from looking at the Clean Air Act as a precautionary act and that ' s why there ' s talk about a margin of safety and so forth . It seems to me that if the confidence bounds
are reasonably tight down to 12 it ' s unreasonable to believe that there ' s a sharp turn at something

-- 10 percent below that . So yeah, the lack of observational data at the lower concentrations accounts for the widening of the bands , but I can ' t
seem to find any reason to believe that it ' s not extrapolate
-able at least 10 or 20 percent below the bounds where the confidence intervals are reasonably tight . So then the choices within the options will need to be based on the Administrator ' s interpretation of the Clean Air Act requirement for margin of safety . In other words , in the absence of response thresholds , how much public health impact resulting from exposure to ambient air PM2 . 5 is acceptable under the Act . The least protective option , 35

-13 , would provide significant additional1

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-1896 (FAX) 112 public health benefits in most of the U . S . in comparison to the current 35

-15 , and these benefits would be greatest in the more humid parts of the U . S . , which I won ' t discuss , but that ' s what I read from the various discussions . That may be because the mass is underestimated in the other parts of the country .And so where was I -- oh, the most protective option would provide significant additional public health benefits to a larger part of the U . S . population , and any of the intermediate options

-- and any other of the intermediate options . So it would not prevent at least some adverse effects among the most susceptible segments of the population .

So my reading of the literature is that any of the options selected would add public health protection , but we ' re not honestly protecting the sensitive segments of the population even with the most restrictive standard that ' s under consideration . So the decision to be made on the selection among the alternative levels for the PM2 . 5 NAAQS will need to be made judiciously with acknowledgment of its public health consequences .

As compared to the previous round for PM, it is no longer justifiable to rely on residual1

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uncertainties as a basis for confronting the need for significant advance in protection . We went through this last time . We were unhappy that the Administrator at that time used uncertainty as an excuse for not protecting the public health in a manner which I think the Clean Air Act intended . And
uncertainties are still there and will be there five years hence . They get narrowed, but they ' ll never go away; and in my view, the precautionary nature of the Clean Air Act with its provision that cost should not be considered, which has been overridden by Reagan ' s cost-benefit rule , but still there in the Act , should be considered .

I ' m not advocating going below the range that ' s been proposed . I think we ' re making incremental progress over the last 30 years in dealing with PM standards and giving the public more protection against adverse effects . And since we ' re now on a five

-year schedule , we don ' t have to wait ten more years for more information to accumulate before we can revisit the issue . The issue will be
revisited within five years , and so I think it ' s reasonable to go with the recommendations of the staff . I would like personally to see them toward the lower end, not necessarily at the lowest end, but1

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toward the lower end as a means of gaining the most possible public health protection that is reasonably achievable .

DR . SAMET : Sverre? DR . VEDAL : Yeah, just a couple of perhaps different perspectives .

When we met the last time , or it may have been
even the time before , we were talking a little bit about levels in context of the Risk Assessment and otherwise ; and we were unhappy and uncomfortable with going below 12 . What ' s changed? What ' s happened since that time ? Well , we ' ve now been presented with information that ' s based on the concentration distributions . That ' s one thing . We ' ve also been presented information based on epi endpoints that have been classified, characterized as being of a suggestive causal nature to influence the concentration range or focus , which I ' m not happy with . I ' m basically still in favor of having something like 12 as a lower bound .

I think the one issue that I would take issue with, with what Mort said, has to do with that issue of uncertainty . It ' s not that you bring up uncertainty to prevent any changes or suggested lowering of the standard, but it has to play a role .1

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And to say that if we had the data , we would find that we would have less uncertainty at a certain concentration . That may well be true , but this is based on current science and the current information suggests that we don ' t have that information .

DR . SAMET : At what point? DR . VEDAL : 12 . DR . SAMET : 12 . So you ' re distinguishing in your mind, or are you distinguishing

-- I just want to be clear
-- between 13 and 12 ?

DR . VEDAL : I am . DR . SAMET : You are , okay . All right . Chris ? DR . FREY : Yeah, these are some different points . In going from what ' s called the evidence based to the risk based
-- and those terms I ' m a little uncomfortable with because the evidence

-based part seemed like it was some evidence but not all evidence and the risk based includes some evidence , but that ' s a semantic thing . There was sort of an obvious disconnect , which I understand why just given the history of how the document evolved . But as a reader it ' s confusing as to why there were various annual and 24

-hour levels in the evidence section, and then in risk section some of those are not1

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-1896 (FAX) 116 analyzed . And then furthermore , in the risk section there ' s some discussion of even a level of ten that
was analyzed but not presented; and having those kinds of disconnects , I just think would be confusing to the Administrator .

I guess another aspect of that comment is that
-- and maybe we need to come back to whether 11 is a reasonable lower bound to come to or not . But just to assume for the sake of argument that it is , some of the options presented in the evidence

-based section of the 11

-35 combination and the 11

-30 combination are not analyzed in the risk assessment ; and it would just seem kind of easy to not give them much weight because there ' s no numbers that go with them from the risk assessment . So that ' s sort of a framing issue in what gets communicated to the Administrator . I don ' t know how plausible it is to do those risk analyses before the Policy Assessment ' s finalized, but I think having some consistency throughout the document would be useful .

Another comment I have is I like the Figures 2

- 11 and 2

-12 that present the percent risk reduction, but I do feel like I need to point out , I think that ' s irrelevant to the NAAQS . The NAAQS is not based on risk reduction . It ' s based on1

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-1896 (FAX) 117 protecting public health with an adequate margin of safety, and presenting risk reductions frames it in a different way and there are framing effects that lead to different decision outcomes . So I think it ' s very important to frame the results in an appropriate way relative to the statutory mandate . And I think the
more appropriate risk characterization is not risk reduction, but it is sort of the absolute risk, the number of cases in each of those scenarios because I don ' t think it ' s a question of , well , what ' s the
-- we ' re not looking at marginal benefit and marginal cost . If we were , then risk reduction would be useful because we could compare that to marginal cost , but I think that that ' s not relevant here .

So I ' m not necessarily saying to take those figures out , but I think something

-- either they need to be replaced or they need to be augmented with
a summary of the bottom
-line results for each case . And I think those summaries need to account , not just for the best or central tendency estimate , but also the confidence interval . And perhaps
-- you know, I realize that the 15 areas that were selected for analysis doesn ' t represent the entire U . S . , but whether those should be summed up to give kind of a bottom line , maybe that ' s something to discuss . But1

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I think it ' s important , given that the standard is supposed to have an adequate margin of safety to report , not only the central tendency, but the confidence bounds of those estimates .

The other thing that I think needs to be brought up , but I hesitate to make this comment because I think the document is kind of cumbersome as it is , but it seems like the risk analysis part is sort of the bottom
-line synthesis that leads into the final conclusions of the document . And somewhere
near the end of the document we need to come back to what are the biases that are not quantified in the risk assessment and does that mean that these estimates

-- do they have some margin of safety built in , are they biased low, which from some of the earlier text may be more likely to be the case , either because of the model forms or it doesn ' t really focus on sensitive subgroups and so on . So I think in interpreting the risk assessment that ' s really important .

I think for internal consistency the risk analysis

-- there ' s an analysis at 14 for the annual and 35 for the 24

-hour, and I don ' t really recall elsewhere in the document motivating that particular analysis . And you know, if staff is not recommending1

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14 , given that it analyzed 14 , it seems like , well , there just should be some explanation of that . And I don ' t feel strongly that 14 should be part of the recommendation, but since it was analyzed, well , why is it not being recommended to the Administrator? And you know, from my perspective it ' s also not clear why combinations like 13 and 30 or 12 and 30 or 11 and 25 weren ' t looked at because those combinations
seem to be potentially motivated by earlier parts of the document even if not explicitly stated .

And then I think, since we ' re trying to do C through E or F as a group, the one other comment I have is looking at peak
-to-mean ratios to inform the level of the 24

-hour standard, I think the document should give more priority to the health effects evidence , not the peak
-to-mean ratios . The peak
-to-mean ratios help interpret whether the 24

-hour or annual standard would be controlling for a given area . But if the recommendation is that , well , there are health effects , short
-term health effects , then , you know, is it unreasonable that the 24

-hour standard should be controlling in some cases , which I think may be appropriate .

That ' s it . DR . SAMET : Before we go on to other committee1

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members , I just wanted to ask Karen on this question raised . It ' s sort of , I guess , consistency between
some of the combinations looked at and levels in the REA and sort of this more limited set that you ' ve advanced . Do you want to comment there ?

DR . MARTIN : I would be happy to . One thing
we have to remember is that in developing the risk assessment , this was done over a year ago . When you lay out the risk assessment that ' s going to help inform policy considerations you have to make upfront choices about what you ' re going to analyze . This is
resource intensive , time intensive . We make choices . As we go through then and get a final Integrated Science Assessment , we get a better handle on understanding the underlying evidence itself . We then look to the evidence discussion to help us refine our thinking on alternative standards that are most appropriately based on that evidence .

It ' s sometimes the case that we didn ' t pick all the most germane options to run through the risk assessment . It just is what it is . It ' s an artifact of how long it takes to do the analytic assessments
versus trying to use the final information in the science assessment to inform our review of the evidence . So it will always be the case that there ' s1

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not a one- for
-one match .

The fact that we don ' t end up reaching a conclusion to consider the full range assessed in the risk assessment doesn ' t mean our considerations
aren ' t informed by what we did do in the risk assessment . So I think it ' s an artifact of just the relative timing and to do all the different pieces of the assessment and it would be surprising to me if up front we picked exactly the combinations that in the end we felt , when you look at everything together, are the most appropriate things to focus on . I agree it ' s less satisfying, but I don ' t know how it could be otherwise .

DR . SAMET : Okay . Rich? MR . POIROT : I wanted to come to the question of the controlling issue . I remember many years ago , when the fine particle standards were brand new, chatting with John Bachmann and seeing a similar scatter plot of 24

-hour versus annual and just making the observation that , gee , it looks like 65 is the perfect number that would guarantee that no site will
ever exceed the 24

-hour but will exceed the annual , and John said thank you . And I think it was -- and I remember kind of agreeing with him at that time that it seemed like good policy to actually have , when we1

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were just starting out , an annual standard that was controlling with the logic that that would tend to seek initial controls over the kinds of sources that affected average concentrations over broad areas . Controlling the big sulfur emitters that were causing the high average concentrations over very large areas would be a great way to begin the process and would be the most efficient way to begin the process rather than going after the more localized sources that would be contributing in different kinds of locations to the higher peak concentrations .

But if we look at this scatter plot which Chris referred to , which is very informative on whatever
-- page 2

-75 , Figure 2

- 10 . And it shows that there are a number of points that are pretty much uniquely in the Pacific northwest or in the northwestern region that are the ones that have these high peak
-to-mean ratios . And I got to looking at the data a little more closely for sites in those regions , and I know what it is for the most part . That ' s winter wood smoke under inversions in mountain valley locations . I know that ' s what it is because I ' ve got one myself in Vermont , and we get very high peak concentrations under warning inversion conditions in cold weather in the winter . That ' s1

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what those extreme ratios are . And it ' s not just wood smoke . It ' s also gasoline and diesel motor vehicle exhaust that peaks at rush hour right when the inversion lid is coming down . All of these carbonaceous , bad
-acting sources and other space-heating, oil

-burning emissions , so that ' s what
we ' re talking about when we see those high peak
-to-mean ratios .

Do we still want to be in this mode where
we ' re saying no , it ' s the big annual , broad sources that we really want to focus our efforts on or should
we be looking toward standards that recognize this is
an entirely different set of sources and it ' s bad in its own right and it ' s going to be very intractable , by the way, to control the emissions of all of those things under these severe meteorological conditions . But still , if it ' s a different effect , I just don ' t understand, as Sverre said, sort of, the logic that
one should be controlling over the other .

The other point I wanted to make on that is that states among -- there are other uses , there are other ways in which these standards get used aside from just developing steps to try to attain them . In the meantime

-- and sometimes the meantime is a long time between the proposal and actually attaining1

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it

-- states are out there forecasting daily air quality values and reporting out to the public and issuing alerts and advisories when extreme conditions
occur, so the
-- and action days and asking people to take protective action, all of which get linked back to the standards and to the air quality indexes which
are based on the standards and are ratio ' ed to the standard .

So if we keep the 24

-hour standard up high at 35 and bring down the annual one because we want the annual one to be controlling, it ' s kind of sending, I think, the wrong message . In fact , the official EPA guidance on what we ' re supposed to be doing for the air quality index and reporting hasn ' t even caught up to the 35 yet . Most states have their own way of doing it anyway . So it ' s another consideration , and at a minimum we ' ve got to get that public messaging
more reflective of the extreme short
-term concentrations .

And the last point I wanted to make about these extreme distributions , not only do they have high peak
-to-mean ratios , 24 hours to annual , they also have high hour
-to-daily ratios . So that we ' re getting a real extreme exposure regime to really bad carbonaceous stuff, and do we really want to say that1

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doesn ' t matter so much? I don ' t know .

DR . SAMET : Thank you . Other
-- DR . MARTIN : I really would like to speak to this issue . There seems to be a lot of confusion about why would it be that we would take this position here given the things you ' re talking about .

I ' m going to start with one general statement . While the Act is precautionary in nature , the Act does say the standards are to be requisite . And as I ' m sure many of you remember, we went through many years of litigation up to the U . S . Supreme Court to clarify what that means . And what means is that the standards are to be neither more nor less stringent than appropriate to protect public health with an adequate margin of safety .

So one question becomes do we create a suite of standards that would result in disproportionately stringent standards across the entire eastern part of the U . S . for the sake of creating a standard that would capture really high one-hour or really high seasonal peaks in the northwest . That ' s what we ' re talking about here .

And I would present to you one policy approach to addressing the problem you ' re describing is if we had sufficient information to set a seasonal1

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standard, if we had sufficient information to set a one-hour standard, we could set those standards that would directly address the kind of seasonal and
one-hour exposures you ' re expressing concern with without creating a suite of standards that would result in potentially extremely more stringent requirements across the broad scope of the U . S . And that ' s the issue we ' re trying to grapple with and that ' s something that we talked about when we presented the results of the risk assessment .

If you recall , when we looked at alternatives where the 24

-hour standard was the controlling standard, you don ' t have to get very low before you start producing scenarios where in order to meet that standard, you ' re , in essence , driving down the annual average to quite low levels , indeed, lower than these levels where we ' re seeing an expansion of confidence ranges . So the concern is that we are -- we would be disproportionately stringent in large areas , in large urban areas across the country, for the sake of chasing the tail of the short
-term distribution .

The other point I would remind us of is

-- I ' m going to try very carefully to say this in a way that ' s accurate -- is that when we look at the aggregated risk across a year associated with daily1

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exposures , the bulk of that risk is coming from days in which the concentrations were around the mean of the distribution . Only very little of the aggregated risk across a whole year is coming from days at the tail of the distribution . So if you use a 24

-hour standard to move that whole distribution, you are really disproportionately affecting places that have peaky distributions because they have to move a whole lot resulting in more much stringent controls relative to an annual level .

And the other perspective is looking both at long
-term exposure risk and short
-term exposure risk, by far and away the bulk of the risk to populations
across the country is coming from long
-term exposure risk . It is clearly driven by moving the mean of that distribution down . And so too , the bulk of the aggregated daily risk across a year is associated with moving the mean of that distribution down, not the upper extreme values .

So the concern that making the annual standard the generally controlling standard is trying to address is to avoid disproportionately stringent impacts in large
-- the vast number of areas in order to chase the tail of that short
-term distribution which contributes very little to the aggregated1

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short
-term risk which in and of itself is much smaller than the long
-term exposure risk . And that fundamentally is what drove the decisions in ' 97 to try to create a suite of standards that would not ignore hot spots and make it a supplemental protection , but would address these kind of policy
concerns ; and that , again, is what we ' re trying to do here . And I just

--

DR . SAMET : Think we got it . DR . MARTIN : -- I didn ' t mean to go off on a tangent , but those issues are fundamentally important

--

DR . SAMET : 30 seconds . (Laughter ) DR . MARTIN : -- from a policy perspective . Yeah . DR . SAMET : Okay . Thanks , Karen .

Chris ? DR . FREY : I just wanted to clarify that
-- I
mean , I think I understand what you said there , but I think

-- does that presume that the implementation of the standard would be such that it ' s sort of a proportional rollback on both annual and 24

-hour concentrations in terms of control requirements or , I think from what Rich was alluding to , was that some1

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of the factors that might lead to the peaks are not necessarily

-- don ' t require a change in the annual , you know, economic activity in a region , that they might be focussed on specific source categories or specific events , you know, kind of like we have ozone alerts now . Well , maybe there ' s a PM alert in the winter and you try to do something based on that . So I mean , I think I understand your point , but I just wonder in implementing it if it ' s really that tied together .

DR . MARTIN : Well , of course , in implementing it the strategies that will be put in place are those strategies that seem most effective and efficient to the states developing the strategies . We ' re not going to set those strategies beyond doing federal
measures that are more broad in nature . So we can ' t know today how much a strategy in any given area would be driven by chasing the peak versus lowering the annual standard . But when we did a whole lot of simulations and simulating just meeting different combinations of standard in conjunction with the risk assessment , using the approaches that we all felt
were most appropriate to consider, you still saw this real extreme effect when you have the 24

-hour standard controlling .1

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DR . FREY : Yeah . I think the point I was just trying to make is I think that analysis presumed a certain way -- a response to the standard that might not be
--

DR . MARTIN : That analysis selected three different ways of looking at it ranging from a very proportional way to a very --

DR . FREY : Right . DR . MARTIN -- peak
-oriented way, and we looked
across all three different approaches .

DR . SAMET : It also seems to me , though, that analysis is external to the considerations that we ' re really addressing now . I mean , they ' re really on the implementation side .

There ' s important stuff buried here in C to F . Let me see if there are other comments .

Frank? DR . SPEIZER : Yeah . I was actually impressed with what Mort said, the idea that the reason the confidence interval widens below 12 , it clearly must be related to the lack of data rather than
uncertainty of effects since you wouldn ' t expect it to change that much .

Now, what concerns me is that by specifying what ' s been specified here , 35

-15
-- or 35

- 13 and1

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30

-1 1 , because that ' s what the risk analysis provided, it seems to me it puts constraints on the Administrator that shouldn ' t be there and that , in fact , somewhere along the way you indicate that this is about the right range . I mean, I think everybody would agree these are about the right range . But those exact numbers are , sort of , within the range or around the range and that there ' s some flexibility about that because of the nature of the beast . As Karen said, she hasn ' t been able to do all the combinations that are possible . I think those combinations are important for the Administrator to have as options . She obviously has them, and I think
we have to indicate that we do not force her to use these particular values . It might be that she will end up with 25

- 12 or 25

-1 1 or something else . And simply because she hasn ' t provided those data , I would hope she would not be constrained in not being able to consider them; and somehow that sort of has to be said, I think, a little more explicitly than it has been put at this point . That ' s about all my comments .

DR . SAMET : In part , these analyses relate back to the risk and exposure assessment , amongst others . I mean , the question of what combinations1

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need to be looked at -- and this goes back to Chris ' s comment about the importance of the , sort of, the burden avoided versus the protection provided in decision

-making . We know that the burden avoided by the nature of the models is something, and how that figures into decision

-making versus the margin of safety to be provided tend to be quite distinct matters .Other comments here ? So I mean, in the end, I think it goes back to Mort ' s starting point , which is , I think he said that , in essence , what is the options . The combinations listed under F are reasonably supported by the scientific evidence available . And then after that , I think the incorporation of margin of safety, which is where the policy judgment lies , really, then reflects this integration of uncertainty and the degree of protection to be afforded and that ' s the matter of judgment where the Administrator will have to pick .

Yeah, Mort? DR . LIPPMANN : Chris raised the point

-- which I think probably ought to be addressed explicitly . I ' ve already moved into the framework of risk reduction because the alternative of , you know, protection of the sensitive segments with margin of1

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-1896 (FAX) 133 safety is just not possible . So perhaps we have to acknowledge that what we ' re talking about is degrees of risk reduction with alternative standards and acknowledge that .

DR . SAMET : So let me make a suggestion

-- We
are roughly at past lunch
-- that we take
-- we probably need to take an hour break . We break until quarter after 1 : 00 and we ' ll just come back and
revisit this and see if there are others who would like to make comments on what is a very important aspect of our discussion .

So let ' s break until quarter after 1 : 00 . (Lunch recess 12 : 18 p . m . - 1 : 21 p . m . ) DR . SAMET : Okay . We ' re back and ready to go . Let ' s see , I think what we were going to do is I think Karen has the monitoring team here , and that
one question about the distribution of monitors between population oriented and
-- it ' s really source oriented, whatever the coding is , we now have an answer . MR . HANLEY : So this is Tim Hanley, and I ' m in the monitoring group of OAQPS .

So there ' s approximately, last I looked, about 930 monitors that are cited appropriate for comparison to the PM2 . 5 NAAQS . And of that 930 ,1

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-1896 (FAX) 134 really all but about a dozen are applicable to the annual standard as well as the daily . Everything ' s applicable to daily if it ' s applicable to the annual . So the states and cities are in fact continuing with the design we had from ' 97 , which was the emphasis on community

-wide monitoring and there ' s only a couple unique cases where it ' s solely cited specific to the daily standard . EPA did not require states to cite specific only for the daily . All of the required sites are emphasized to be community wide , to represent community

-wide air quality .

DR . SAMET : Okay . Thanks . That was my recollection as well . Questions ?

I mean , I think what this means is some of our earlier discussion was probably perhaps a little bit
overstated in the potential to analyze these different categories of monitors and address the questions that we had at hand .

DR . SPEIZER : John, this is Frank . DR . SAMET : Yeah, Tom? MR . MOORE : So I ' m not going to dispute what Tim said because I believe that ' s true .

DR . SPEIZER : -- of those monitors , how many -- MR . MOORE : It ' s a rather imprecise1

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classification

--

DR . SPEIZER : Can you hear me? MR . MOORE : -- because it sort of depends on season , time of day, a variety of issues . So sometimes a community

-wide monitor can be strongly influenced by local sources , so .

DR . SAMET : Yeah, I ' m sure that ' s true . Rich? MR . POIROT : So a state then could set up its
own monitor that would not be community oriented to look at a specific purpose and have that data not count towards the annual standard determination?

MR . HANLEY : Yeah, Rich . So there ' s a couple of things there . So EPA insists in the monitoring requirements that the sites be set up to represent community

-wide air quality . So if a state in addition to meeting those requirements wanted to set up a site to look at a unique source or , really, anything that you could put under unique source , whether that be a facility or, you know, some sort of operation or construction, it can do so . And if the data are -- if more than two years of data are produced and the state no longer calls that a special purpose monitor , then in fact that data is expected to be compared to the daily standard, yes .1

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DR . BRAIN : Do all 930 have both PM10 and PM2 . 5 and are there any that are doing experimental things , looking at ultrafines ?

MR . HANLEY : It ' s a great question . The unfortunate answer is no , there ' s not a -- certainly not 930 co-located 2 . 5 and 10 monitors in that sense . A fair amount of them are co-located . There are a few agencies that are pursuing some novel metrics such as ultrafines .

For instance , South Coast , we just had a meeting two weeks ago here in RTP, and they are looking to deploy potentially

-- they ' re certainly going to deploy one , possibly two , of the TSI ultrafine monitors in their agency . If we could, we would probably do a few more .

Other things going on, there ' s some continuous chemical speciation at about ten sites nationally . It is probably not as organized as it needs to be , meaning some agencies use , perhaps , one instrument company, another agency might use another . We on one hand, want to get that organized . On the other hand, we don ' t want to get in the way of good work by the cities and states . For instance , one agency might be focusing on nitrate . I know that ' s happening out in the Utah Valley . Another agency might be focussing1

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on sulfate or carbons .

DR . BRAIN : So out of the 930 , so you said they ' re not all both 10 and 2 . 5 ?

MR . HANLEY : No . DR . BRAIN : How many of each and then how many are -- do you have any estimate?

MR . HANLEY : We need to get back to you on that so we can give you a solid answer . Even within that subset , we would break it out by, of the PM10 monitors , you might be aware there ' s high volume , there ' s low volume , there ' s continuous . You can slice and dice it a few ways , and I think we can get back to you guys on that with a number .

DR . SAMET : Yeah, I think the answer is it ' s a minority of them . We did that paper on coarse mass PM with the Medicare data . It ' s a minority, I think, have both and a declining number , of course .

MR . HANLEY : Yes , there is . That ' s a good point , Dr . Samet .

So when we looked at the inventory of monitors
over the last several years , it ' s been steadily declining, maybe a couple percent a year . But there
was a little bit of a drop off , let ' s see , in calendar year 2008 and 2009 on PM10 monitoring . And that might continue as the Agency -- excuse me , as1

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the state agencies refocus their monitoring priorities with various changes in NAAQS .

DR . SAMET : Okay . Ted? DR . RUSSELL : So just to make sure it ' s clear, if that monitor

-- this gets back to the original question , if that monitor has more than two years ' worth of data, it actually becomes a community monitor?

DR . SAMET : Okay . That ' s -- MR . HANLEY : I mean , that ' s -- DR . RUSSELL : How would you actually have
-- is there a way that you would have a monitor that is showing non-attainment with two years ' worth of data that then would not be used in the attainment process ?

MR . HANLEY : Right . DR . RUSSELL : So what ' s standard? MR . HANLEY : Yeah, let me pick at the words and make sure we ' re in the same place here .

So you say community wide . If an agency sites
a monitor next to a unique source and there ' s a neighborhood there , we would call that population oriented . We wouldn ' t necessarily call that community

-wide air quality .

DR . RUSSELL : But population oriented, okay .1

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MR . HANLEY : Population oriented, yes . DR . RUSSELL : So really, once it ' s got two years ' worth of data, even if it is a hot spot --

MR . HANLEY : We have a responsibility to use the data .

DR . RUSSELL : You would have to use that data? MR . HANLEY : Yes . DR . SAMET : Okay . Thank you , Tim . I think what we should do is just turn back to 3 again and make sure we ' re done .

Mort ? DR . LIPPMANN : While Tim is here why don ' t we get some expert information on the coarse particle monitoring because we ' ll be discussing that next .

DR . MARTIN : Tim is going to stay this afternoon . So as those topics come up, coarse particles , Tim and Joann Rice , his colleague , will be here to address them at that point if you ' d rather .

DR . SAMET : Okay . So let ' s just revisit 3 . DR . SPEIZER : This is Frank . Can I get a question in?

DR . SAMET : We had a lengthy discussion on the specific issues brought up under item A . We sort of had a very appropriate general discussion about items C through F, which really sort of feed into the1

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bottom line on the recommendations that might come for the 24

-hour and annual max .

So let me ask, are there additional comments
or thoughts now that you ' ve all been fortified by lunch? DR . ASHBAUGH : John , I want to say I don ' t quite understand the argument or the discussion on pages 2

-73 to 2

-74 regarding that graph and the diagonal lines . If you could explain that a little clearer, I ' d appreciate it .

DR . SAMET : Let ' s see , Lowell , you mean the figure

-- oh, the figure up there . Okay .

DR . ASHBAUGH : Yeah, the figure that ' s up there , Figure 2

-10 . And in particular, why do you conclude it ' s appropriate? How do you come to the conclusion that it ' s appropriate to also consider the 24

-hour standard of 30 and in conjunction with the annual standard of 11 , how you got to that conclusion .

DR . MARTIN : Okay . You ' re asking for clarification of the discussion that ' s here relative to that .What we were looking to do , as we said before , was to pick a level of the 24

-hour standard that would provide supplemental protection, while not1

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-1896 (FAX) 141 becoming the controlling standard in broad areas across the country, generally controlling, retaining the generally controlling annual . And so we ' re looking at the ratios here ; and if the question is about the arithmetic of using 2 and a half to 3 as a ratio , that we would be trying to target for the ratio between the 24

-hour standard level and an annual standard level . That ' s basically what we ' re looking at , and we ' re looking at some general ranges relative to that .

DR . ASHBAUGH : Well , what I see from going from annual 12

-- what would it be , going from a 12 /35 to -- which one is it

-- 11 / 30 , that puts a lot of sites into both the annual and the 24

-hour standard having an effect . Am I looking at that wrong? DR . MARTIN : I didn ' t hear the last sentence you said .

DR . ASHBAUGH : It looks like to me as if going from the 12 / 35 to an 11 /30 , there are a lot of sites that then exceed both levels , not so much the 24

-hour standard remains controlling, but a lot more of them exceed both levels . And maybe I ' m just not looking at it right . I ' m not quite sure what
-- maybe I ' m just not seeing it .1

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If you bring the 24

-hour design line down from 35 to 30 and you bring the annual level to the left from 12 to 11 , that just adds a lot of sites into the upper right quadrant so they ' re in violation of both standards . Am I just not looking at it correctly or why does that mean that the 24

-hour standard is controlling when it would violate both of them?

DR . MARTIN : What we ' re looking to avoid with these combination of levels is a situation where the 24

-hour standard would either

-- would be the controlling one for the amount of reduction to be gotten . We don ' t have the 11 line on this graph, so .

DR . ASHBAUGH : Yeah, I know . I drew it on myself . DR . MARTIN : Okay .

DR . ASHBAUGH : Really, if you push the annual design value to the left , that means more sites are in violation of the annual level .

DR . MARTIN : Yes . DR . ASHBAUGH : So that maintains the annual level is the controlling standard . But if you ' re simultaneously pulling the 24

-hour design value down , that puts more of them in violation of the 24

-hour standard as well . So how does it maintain

-- how does it keep the annual standard as the controlling1

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standard?

DR . MARTIN : Well , if an area doesn ' t attain either standard, then the question becomes which standard would require greater reduction in order to meet . So it ' s a question of how much above the different standard levels you are in terms of how much above the annual and how much above the 24 hour and which is proportionately more above the standard level than the other .

DR . ASHBAUGH : Okay . I don ' t -- I can see where they ' re placed, but I ' m not quite sure how that is affected; but I ' ll let it go for now .

DR . SUH : Can I - maybe I can help in some way, or maybe I ' ll confuse things even more .

But I guess the way I was thinking about these lines is they could be sort of seen as quantile regression lines looking at the upper bound of the relationship of the scatter plot between the two endpoints .

DR . SPEIZER : Speak into the mic . DR . SUH : And so that 12 /35 line , basically it could be seen as , like , maybe the 25th or the 80th quantile or the 90th quantile percentile of that scatter plot line ignoring the light blue .

UNIDENTIFIED PARTICIPANT ON SPEAKER PHONE :1

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Please speak louder .

DR . SUH : So then what would happen is if you just go down that 12 / 35 line and you go down to 11 , you get to a level that ' s approximate but not quite equal to 30 . So just maybe out of simplicity, it was the 11 /30 . That ' s the way I read it , but maybe it
wasn ' t quite right . Okay .

DR . SAMET : Okay . Other comments on this ? (No response . ) DR . SAMET : Okay . Thank you , Tim . I gather
we ' ll be back to you . So let ' s go back . I ' m still trying to just make sure that before we move on to Charge Question 4 that there are no -- nothing left
on Charge Question 3 . No other comments ?

(No response . ) DR . SAMET : Okay . Then we ' re on to 4 . Sverre , you ' re the lead here . COMMENTS ON CHARGE QUESTION NO . 4 :

DR . VEDAL : There wasn ' t much to say about
-- at least from my perspective , about point 4 . I think the main thing to note here is , to me this has the flavor of more , sort of , pointing out future research priorities or topics rather than necessarily the
uncertainties that influence decisions on the NAAQS . And I guess the way I think I read in someone ' s1

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comments , not mine , that one thing that this lacked
was some prioritization of topics or points . And I think that may be one way of getting at that , is what
are the things that we really need to know to reduce the uncertainties that are relevant to the NAAQS . And the one point that sticks out in all of the recommendations is the issue that comes up perennially is where you make the decision on the level . And there ' s only one point that kind of addresses that , and that ' s to try to flesh out information at that lower end of the concentration

-response relationship that we ' re struggling with now .

All of the other points , I think, are good
ones . There are things that need to be done from a research point of view and that will have an influence on what the NAAQS is going to look like at
some point in the future , but the thing that keeps coming up again and again is this issue of lack of data at that part of the concentration

-response function that we need to focus on . And one way of doing that is , well , we need more data, more studies , perhaps , that straddle those types of concentrations , more studies that provide information on bounds of the concentration

-response function .1

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So I think I like the whole thing . I like all the points that are there , but perhaps some bit of prioritization as to what do we really need to know for the next round .

I didn ' t get any comments from others , and probably just go around, maybe , the other members of that question .

DR . SAMET : Okay . So I think we have Chris and Kent on the list as well .

DR . FREY : Yeah . I agree with the idea that I didn ' t really see an overview of the key uncertainties , and I think that would actually be helpful because it

-- I guess one thing that it also is missing, but it ' s hard to do , is to really enumerate what are the priorities for these various research topics . And if the section started out with
an overview of here are the key uncertainties , maybe in some priority order by importance , then that would help prioritize some of the research recommendations .

A couple of comments I had just in terms of things that are not in the recommendations relate to setting the stage to be able to model human exposure in a future revision, which, if you remember when we started this process for this review, EPA was planning to do some exposure modeling work, and then1

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that kind of got dropped . And I think it would be desirable to see that move forward for the next revision .

There are a few exposure things that are recommended but some that are not recommended that I think are important . In order to do , say, a probabilistic scenario

-based exposure model activity, there also has to be activity data to support that . That exposure needs to take into account human diary data as to where people spend their time . And there is a consolidated human activity database
-- it ' s called CHAD -- that has , I think more than 20 , 000 diaries . But when you start to stratify that by gender and age group, and if you want to look at particular sensitive subgroups , then there are not a lot of diaries in that database . So I think making efforts to develop the diary database to support exposure assessment would be helpful .

A lot of exposure to ambient PM takes place indoors because of penetration to home , microenvironments or work, school , bar, restaurant , vehicle . And there is some data on the penetration of PM2 . 5 mass into these microenvironments , but there ' s really very little data that allows it to differentiate by PM concentration, for example ; and I1

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think that would be helpful .

And likewise , I don ' t think there really is much exposure work in this vein going on with regard to ultrafine particles . So I think if the committee thinks that exposure assessment is something that we should see more of, that these kinds of recommendations should be included .

That ' s it . Thanks . DR . SAMET : Kent? DR . PINKERTON : I agree with what comments have been made so far . I think it ' s really important for a document like this to actually have a section
on future research and data collection needs , and so I think this is particularly important and I applaud the staff for putting this into the document .

In terms of priorities , although they ' re not listed, I do think that they are reflected in some of the things that are stated, such as for the epidemiological evidence . They continue to emphasize the importance of the fine fraction looking at PM2 . 5 components , sources and the subfraction , the ultrafines . And I think those are very good points .

I think it ' s important , though, that this
seems to have more of a flavor of human exposures , epidemiological studies ; and I think that it is1

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-1896 (FAX) 149 important that we continue to consider the importance in the role of toxicology in better understanding the biological plausibility and the potential mechanisms by which things may be occurring .

I ' d also like to emphasize the emphasis that
we ' ve placed on ultrafine particles is very critical , but I think it ' s also important to even have research that better understands what happens to ultrafine particles over time , especially as they may contribute to PM2 . 5 through their accumulation . It does appear that they ' re emerging in the toxicology literature , at least , that PM2 . 5 in many regards has
more of an effect than ultrafines ; but again, that ' s a very mixed message that we ' re seeing . But it continues to become a bit more blurred; and therefore , I think research needs are critical in better understanding that relationship between ultrafine particles and the fine particles .

Although it ' s not the mission, I believe at this point in time in this document , I do believe it ' s important to consider the co-pollutant exposures . And again , that ' s one of the priorities that is mentioned here ; but also exposure-related factors are important . And the point that I would want to make is the emerging importance of climate in1

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how that may affect PM formation . I know that there ' s a very nice part of this in Chapter 3 that really talks about climate , but I think it ' s important for us to keep that in mind in terms of the emerging research needs , especially as we look at climate , whether it ' s cooling or heating up of the climate and how that impacts on dust generation , wildfires and even the unrelated aspects of the length of the season for pollens .

Again, I would just emphasize that in this research document , although it ' s not totally excluded, I think there needs to be emphasis on , not only the human component , but also the toxicology and doing studies along those lines .

Thanks . DR . SAMET : So you were thinking about California when you were thinking dust storms and fires ? DR . PINKERTON : Yes .

DR . SAMET : Just , maybe a brief comment , Mort , then I ' ll get to you . Actually, I think maybe it was Chris who said this . There ' s a section that starts off in this section we briefly discussed, key certainties . The discussion of key uncertainties
redefines brief . It ' s roughly nonexistent . And I1

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think if you had really discussed the key
uncertainties , I think in several contexts , then the priorities would have flowed . I think coming out of
our discussion around items

-- everything under topic 3 , which really had to do with the nature of the exposure-response relationship at lower concentrations if there ' s a continuation of the current approach and the same indicators , that just has to be sitting there as a key uncertainty; and, you know, whether further epidemiological research will help give any sharper answers at these low concentrations , I think, is uncertain, particularly if we ' re left with, sort of, the current family of observational studies for the next review . I mean , I don ' t think it ' s likely that we ' re going to have a major new cohort coming at the time of the next review . So I think that merits some thought and I think fits in with Kent ' s comment about don ' t forget all the other lines of research that might help us shore up in a mechanistic basis what the exposure-response relationship could look like . You know, there ' s just a fine list of priorities here . We ' ve all seen this list before . So I don ' t think it ' s been shaped by what came before , so I think there should be that table of key uncertainties and1

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then what research is needed . If there ' s going to be
a change in indicator , then obviously there ' s a lot of work to be done and that will open up a whole host of new uncertainties .

Mort and then Joe . DR . LIPPMANN : I looked at the heading, uncertainties and areas for future research and data collection

-- I ' m glad they mention data collection . But I ' m looking forward, not just to the
uncertainties that we ' ve been discussing, which clearly need to be addressed, but what will be needed five years down the road as , are we going to be back here bemoaning the same state --

DR . SPEIZER : Speak up , please . DR . LIPPMANN : -- of uncertainty that we face and, even if that were sharpened up a little bit , would still be a lot of things to deal with .

And so I ' ll beat my favored horse again , and that is the monitoring program . Not only, as Phil has remarked do we need to move to daily measurements , presumably instrumental measurements to get better statistics , but what are we measuring . The speciation network of fine particles has been very interesting and has put out some new thoughts about what needs to be done , but it ' s still very1

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limited . Again , it ' s useful for the annual standard, but not for the daily standard in terms of acute effects of components of particles .

And so I think if we ' re going to be in significantly better shape in the next round
-- which is only five years away and not ten years away as in the past -- EPA needs to move more quickly to decide what it can do , what resources it will need to find to do it because clearly this is not a trivial expense . Do we need to identify those components of fine particles which are responsible for much more than a proportionate share of the health impacts . Obviously, more efficient control strategies to deal with public health protection could be mounted if we knew which sources of pollution were most profitably reduced in terms of the health benefits . And clearly, EPA ' s been thinking about this . Beth has been involved leading in a workshop role in what more monitoring could be done . And just saying that it ' s desirable is not sufficient . Resources need to be developed .

It looks to me like black carbon and metals
are most likely driving the effects much more than
mass , but we can only speculate on a limited database about that . So what about the uncertainties and data1

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collection going forward . Thinking five years from
now, not just about the issues we ' ve been discussing, but what would we like to know and that would significantly change the review of the next round .

Now, having mass standards for components is not the only way . They could be handled as toxic components and source controls could be imposed that way . So it ' s not necessarily inconsistent to continue to have mass-based standards based on size distribution . That ' s reasonable , but it may not be sufficient .

But the monitoring should be looked at to
serve several purposes as it is . Why do you have speciation monitoring in the first place? CASAC helped endorse that and it ' s generated useful data . But clearly, the monitoring should be looked at in a broader sense than just compliance with mass standards .

DR . SAMET : Okay . Joe? DR . HELBLE : Let me just echo what Mort said . I think, in reading this document , in part because CASAC asked you to be concise and clear in putting this particular version together , the document ' s structured in such a way, segmented in different chapters , that makes sense in most places except , in1

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my view, in looking at key areas of uncertainty and future research .

And as I read through this in sections 2 . 5 , 3 . 5 , 4 . 5 , and even wherever it appeared in chapter 5 , there were some themes that I found to be consistently repeated throughout , this issue of monitoring, of speciation monitoring or composition monitoring, frequency of monitoring is applicable in all of the different aspects that are being addressed in terms of Primary and Secondary Standards here . So what I was hoping to get a sense of and didn ' t was , since funding ' s limited, what are the Agency ' s overall priorities in getting ready for the next review five years down the road .

If we looked at each of these sections , if we looked at them in combination, right , you can lay out
a series of overall tasks and priorities . So what ' s most important to answer the broadest number of questions in getting ready for the next review . And I don ' t know if that ' s something the Agency is looking at CASAC to provide . I thought it would come out in the document , and it didn ' t .

DR . SAMET : Okay . Others on question 4 ? DR . SPEIZER : John, this is Frank . DR . SAMET : Frank .1

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DR . SPEIZER : I ' d like to speak to this a little bit . Can you hear me ?

DR . SAMET : Go ahead . DR . SPEIZER : I want to second what just was said in the sense that what comes across is a laundry list without

-- and a good laundry list , but without priority . And maybe it is the place for CASAC to
come to some consensus as to what are the sharpest two phenomenon that needs to be explored, or two or three that needs to be explored, that will help us help the Agency five years down the road .

And not -- what I ' m concerned about is that there are two avenues . One is that would say, yeah, let ' s help decide what we should do with the same indicators five years down the road and let ' s see what we can do
-- that ' s one avenue . And that leads to the question of uncertainties and lower levels and
so forth . But the other avenue is what should be the
new approach to what the indicator ought to be , and that gets us into the question of, in the broad
sense , of speciation and potentially co-pollutants .

And it seems to me , those two categories , if you -- if EPA hasn ' t got enough money to solve any of these problems . But in fact , if we start to go down the avenue of, in a broad sense , what the speciation1

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is , both chemically and size

-wise , and explore
co-pollutants , I think we ' ll move at least in the direction that I would hope that most people want to
move in .Now, the question is can we come to some consensus within our committee that would be useful
as a position to take for EPA, and I don ' t know what the answer to that is , whether we can first come to a consensus or whether it ' s useful to do it .

DR . SAMET : So Vanessa ' s going to make some comments , and I think both your comments and those that came before highlight a few things . One is that there is a need for prioritization . Second, that anything said about PM necessarily really spills over to the other pollutants and it becomes a broader question of what scientific priorities should be around air quality in general .

Vanessa? DR . VU : Thanks , John . So I know that within the Agency, OAQPS interacted with Dr . Dan Costa, who is the national program director for the air pollution program . He
oversees the research, both intramural and extramural research program, the ORD, trying to address the next five , ten years with regard to air pollution1

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research, not just only on the criteria pollutant , which includes PM and ozone and NOx, SOx, but also on the air toxic side as well .

So besides the Advisory Board has undertaken the 33 , 000

-foot kind of feedback to the Agency, but I really think it ' s useful that I would ask the CASAC if you are willing to have some kind of a review that will ask ORD and Dan Costa come in and then you can really help the Agency look at particularly the multi

-pollutant approaches . I know that ' s the way -- and monitoring issues and all that kind of issues . I know that Dan Costa has been talking to the other parts of SAB , but I think it ' s useful for CASAC body to really be on the same page where you all think it ' s important .

DR . SAMET : Thank you . Mort ? DR . LIPPMANN : Yeah, I think we ' re getting somewhere . CASAC has a unique statutory rule within SAB and one of its responsibilities , which it hasn ' t exercised all that much, is to advise the Administrator on the need for an adequacy of standards . And you know, mostly, we get together in places like this at the request of the Agency to help them do their job ; but to a much lesser extent have
we taken on the charge within the Clean Air Act to1

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think about and advise the Administrator on the needs for clean air research .

DR . VU : Yeah, I agree with you, Mort . And I will talk to Dan and colleagues and OAQPS on how to organize something like some kind of advice on the research needs to really focus on strengthening the NAAQS review .

DR . SAMET : Okay . And I think it ' s -- I think for these comments in particular , I mean, giving some priorities and laying out the key uncertainties , I think, giving emphasis to monitoring; but again , also when we fold this into our comments for you , I guess you ' ll be
-- believe that maybe there should be this broader review around the NAAQS , pollutants and
research in general .

Yeah, Bill ? DR . MALM : Just a quick comment since we ' re talking about general monitoring strategies here . One shouldn ' t forget the cutpoint , 2 and a half
versus 1 or something of that sort or 2 and a half
versus point 9 . If you ' re going to change the strategy and put out a monitoring system that ' s different from what ' s currently out there now, then
one ought to -- especially if you ' re going to talk about a coarse particle standard independent of a1

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fine particle standard
-- you ought to get the cutpoint right , and 2 and a half isn ' t it .

DR . SAMET : Yeah . We ' ve certainly we had some of that discussion before ; and again , that gets back into the circularity of those of us who do observational studies look at what ' s there and there ' s this self
-reenforcing . But I think we can make that point again , and that again would be a useful point if there were this general discussion you could get beyond the regulatory issues and talk a bit more about science .

Okay . Let ' s move on to our Charge Question 5 . Joe , that ' s you , and your team is down to you and Mort . COMMENTS ON CHARGE QUESTION NO . 5 :

DR . BRAIN : Yes . So I really want to divide my comments into three parts . I think the first point is that the discussion we ' ve been having for the last two hours is very relevant to the coarse particles . So all the reservations , the concerns about the sampling network and how it determines the health outcome research, it all kind of applies . In fact , I want to finish up by really underlining the need for , I think, a subcommittee to address future directions . So keep in mind that we ' ve already1

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talked about many important aspects of the coarse particle situation .

Number 2

-- Charge Question 5 has two parts , and the responses from Bob Phalen, who sent in some comments , and Mort and I are really pretty simple and straightforward . We think the second draft is much improved from the first draft and the EPA staff has really taken advantage of the evidence that ' s available , and they really have presented the basis for reviewing the coarse particle standard .

Of course , as you know, there are inherent difficulties . Hardly anybody ever mentions measures directly the coarse fraction . It ' s usually a matter of subtracting the PM2 . 5 from the PM10 . And we ' ve now heard that co-located sampling is relatively rare ; and, of course , that also then spills over to the health outcomes research . Again , we have to look at PM10 studies and sort of guess and estimate how much is attributable to the PM2 . 5 fraction and how much is directly attributable to the coarse fraction . So those are kind of familiar concerns and reservations , but they ' re there part and parcel of the data we have . And I think the consensus was that Chapter 3 reads well and the EPA staff has done its very best1

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to apply the limited amount of specific information relating to coarse particles . They ' ve extrapolated, and they ' ve extracted what they could .

B is sort of a related question, has staff appropriately applied this approach in reviewing the adequacy of the current standard and then analyzed potential alternative standards . And again , I think the consensus was , yes , given the inherent deficiencies that we ' ve already mentioned, EPA staff has done its best . And again, there ' s a good discussion of how the data is relevant to both the current standards and to several possible alternative standards . Again , some of the same things that you ' ve heard . There are other alternative standards that could have been discussed; but again , there are staff limitations . So that ' s a simple , straightforward and, I think, positive answer to Charge Questions A and B .

And the third set of comments is really just to repeat what I ' ve been hearing and, I think, the
consensus that ' s been emerging . I think what ' s needed is not to beef up and work on the research needs in this report . I mean, this report is really about the PM standard and what the Administrator needs to know to make a decision . I think we really1

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need a separate document . We need a separate working group composed of CASAC consultants and EPA staff to really sit down and talk about what ' s needed, I think, not only for the next five or ten years , but when you think of
-- you know, how long did it take to really acquire PM2 . 5 data . So if we were really to talk about different size cuts and say, yes , one makes a lot more sense to create an appropriate sampling strategy, to deploy them, to collect the data , to get correlated health effects data , we ' re really talking about , you know, data that would be in hand in 10 or 20 years . But it ' s never going to happen unless we have a very serious conversation .

So you know, I have a little list of topics that I think such a committee and such a report would deal with . Clearly, size cuts is one of them . What
are the devices , where should they be located . The whole role of ultrafines , again, the EU is moving ahead with some standards relating to ultrafines . A lot of interest in composition and speciation ; and again, how do we distinguish crustal dust from composition products . And even for the ultrafines , a lot of the very familiar sources such as diesels , if you look carefully they have ultrafines . And I think there ' s a range of opinions as to whether that ' s a1

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serious concern or not . But in any case , we need to have data, again, both animal tox data as well as human data .

Another topic that I think is left out of this report , and I don ' t know whether it should be at least mentioned, is nasal deposition . Again, it ' s interesting that the coarse fraction is really looked at in the context of thoracic dose . And we think of the nose as a filter; and if the particles escape the
nose , either because we ' ve switched to mouth breathing during exercise or snoring, or -- you know, we ' re really saying what fraction of the particles deposit in the airways and the lungs where the action is ; but I think there ' s increasing interest in the
nose as a source of injury, inflammation, allergens that may bind to coarse particles that are generated industrially . And then even the possibility

-- more than the possibility, the demonstration that some soluble metals can be absorbed in the nose , go through olfactory sensory neurons , through the olfactory bulb to the brain . And so I think this

-- again, I don ' t think we need so much to incorporate into this report . It ' s too late for that , but I think it ' s an area for future research .

And then going back to the ISA, I think we1

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-1896 (FAX) 165 really need to think of what are the health outcomes that should be targeted for the future . Again, the
ones that I remember as rising to the surface are premature birth, which is a huge and unsolved problem in the United States , let alone neurobehavioral and other reproductive outcomes .

So I think, I really like the way the discussion is moving and I think we should bite the bullet and, rather than think about beefing up and streamlining the research directions , which I ' m not
sure the Administrator will have time to look at in context of deciding about the PM standard itself, I think CASAC should really come out of this meeting with a recommendation for a joint meeting that addresses this list of topics so that 5 , 10 , 20 years from now we have the data that we say we need and want . DR . SAMET : Okay . Mort? I think you were the other
-- yeah, you were the other commentor on this .

DR . LIPPMANN : I have nothing further to add
now . I reserve my discussion for the final part of this . DR . SAMET : I do think we can circle back to this tomorrow, but in terms of the coarse and, of
course , the PM2 . 5, I just can ' t imagine a discussion1

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-1896 (FAX) 166 going on five years from now if the science base is the same where Sverre is sitting there saying, no , I think it should be 11 . 5 and not 11 . 4 , or whatever the extent it is . I mean , at the range we moved into , I think the discussion eventually really in terms of protecting health will have to shift to perhaps more sensitive and refined indicators and methods . I think the question that ' s being raised is how do we get there as we , sort of, I think, in a way, see us coming to , sort of, the logical conclusion of one sort of approach as the levels have been driven , have
come down more and more .

DR . LIPPMANN : On that point , John, I think the cutpoint for fine particles is not a simple one . What 2 . 5 does compared to 1 is really relate more to deep lung deposition and not just the composition . If you look at it purely in terms of composition and
source origin, then one makes sense except in the humid east where things grow into the 2 micron range , at least . That would be as dry particles less than 1 . DR . SPEIZER : Mort , can you speak more into the microphone?

DR . LIPPMANN : Well , I ' ve got it on . Sorry, Frank .1

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I ' m saying that 2 . 5 is a compromise that ' s based in part upon source , but it ' s also based in part on where the particles go and deposit within the respiratory tract . That is , something around 3 , 3 and a half is the cutpoint for particles getting through the conductive airways and depositing in the deep lung, and then access to the bloodstream is an important factor and its distribution within the body . So it ' s an issue that certainly can be further discussed and better defined, but it isn ' t necessarily true as some people in the Panel think that we should be purists and cut it at 1 micron . If
we ' re talking about particles and health, it ' s more complex than that .

DR . BRAIN : But I think you anticipate the outcome of the discussion . I mean , it ' s also not obvious that 2 . 5 is the ideal cutpoint if we were starting from scratch .

DR . LIPPMANN : No , it isn ' t . DR . BRAIN : So I think, you know, you make good points , but it needs to be discussed and argued .

DR . LIPPMANN : Not argued . Discussed . I think there are good reasons and we have better data . Deposition data has grown and improved since the original decision was made that that was a reasonable1

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one . It was also chosen in part because Harvard had
a 2 . 1 cut sampler in six cities and we were going with the available data , which were pretty convincing that in the six

-city study that the effects were much
more closely related to the fines at 2 . 1 cut than to the larger particles up to 10 or 15 . But these are all the issues and I think I see a lot of agreement that these issues need to be elaborated further so that we ' re not stuck with the same limited information base for the next round .

DR . SAMET : I think, just to reenforce the complexity, Joe talked about the nose , which, of
course , is a site of high fractional deposition of ultrafines . So again , there ' s complexities that are overlooked . I think actually tomorrow we should come back to the proposal that Vanessa raised having discussed all the issues .

Why don ' t we move on to Charge Question 6 , Wayne , which is you . COMMENTS ON CHARGE QUESTION NO . 6 :

DR . CASCIO : So Charge Question 6 relates to the adequacy of the current PM10 standard, and the question that ' s asked is , what are the Panel ' s views of the alternative approaches presented for1

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consideration of the evidence and its uncertainties
as they relate to the adequacy of the current standard found in section 3 . 2 .

And Drs . Henderson, Avol and I took a look at that ; and the report is that we all agree and there
was nothing really written of any substance other than we were in agreement with the dual approach that
was proposed by EPA to look at this .

Just to summarize very briefly, two alternative approaches were presented . They consider the scientific evidence and its uncertainties as they relate to the adequacy of the current standard . Both approaches recognize the value and the limitations of existing data, but the first approach emphasizes the strengths of the associations in multi

-city studies and trends in single

-city studies between health endpoints and that these health effects can occur even when below the current standard .

This approach gives significant weight to a significant or a limited number of studies that generally reported PM10 to 2 . 5 effect estimates that remain positive when evaluated in co-pollutant models . And, likewise , limited controlled human exposure PM2 . 5 studies showing decreases in heart rate variability and pulmonary inflammation that is judged1

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to be adequate to support a plausibility argument between the associations reported in the epi studies .

By contrast , the other approach gives greater weight to the lack of robustness of the statistical associations , the limited data and attendant uncertainties . These include the observations of positive trends rather than statistically significant associations between PM10 and mortality and morbidity in some studies as well as examples of PM10 levels far in excess of the PM standard not associated with statistically significant health effects . The limited number of studies examining the impact of
co-pollutants on human exposures and animal toxicology studies providing biological plausibility, while viewed as sufficient in the alternative approach, is viewed as a potential limitation here . The challenge of accurate exposure assessment in epi studies as well as the lack of compositional data is also viewed as a limitation .

So looking at these two , kind of, disparate approaches , it seemed very reasonable to use them as the backdrop for further discussion .

Thank you . DR . SAMET : Okay . Let ' s see , Rogene . DR . HENDERSON : Well , I think Wayne pretty1

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much summed it up , all the thoughts that I had .

I liked the fact that they emphasized studies where they actually had measured 10 minus 2 . 5 and they give all the data; and some of the studies are positive and not significant , some are positive and
are statistically significant .

They presented all of the evidence , I think, and it was very well written ; and then they give these two approaches . You could either look at it as saying, well , you know, because some of the studies showed the significant differences in effect that we should consider lowering the standard . Or you could say, well , it ' s really kind of on the bubble if they
can barely detect these changes ; and so we could consider retaining the current standard .

And so I thought it was well done ; and I appreciated them describing the two approaches because , in my mind, I was saying, now, is this really going, you know
-- need to be changed or not . So I thought it was a well written section .

DR . SAMET : Ed? PROF . AVOL : Yeah, I agree . I think Wayne and Rogena pretty much said it all .

I just would point out one additional thing, and that is with regard to the document , which I1

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think was very well done . It tends
-- by nature some of the questions asked and the presentation is , in fact , sort of a reactive sort of document addressing
some issues and dealing directly with them . And as you ' ve heard, sort of , this ground swell here , I think we ' re also asking to look forward to a more proactive document in terms of looking forward to see what is needed .

In the case of coarse particles information , in fact , as Kent pointed out , there are a large number of monitors out there , not so many of which actually monitor directly coarses , in fact , sort of a commingling of the existing network that has some PM2 . 5 samples and some co-located PM10 samplers . So
we ' re faced with, sort of, the challenge of how to get useful information from both of those , sort of , coexisting from different instrumentation , different monitoring, etc .

So I think there are some challenges ahead, but I do think that in terms of the adequacy of the current standard and the description and the discussion for here , this was well done and appropriate , but I do think we should be looking forward to how we use what ' s out there and how we move towards where we want to be .1

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DR . HENDERSON : I just wanted to add, to emphasize what Ed just said, the composition of these
coarse particles has got to be very important ; and we all know that composition is important , but if we ' re going to have a special session on looking at this , I think

-- I push for the still looking at composition because it ' s not all particles are equal .

DR . SAMET : So going back, I mean , I think I just want to rephrase what I think I heard from all of you and what the document says . What you ' re saying is that the evidence hangs in the balance , if you will , between whether this current standard is or is not adequate in terms of public health protection . Is that a comment that
-- and okay . Yeah, Mort ?

DR . LIPPMANN . I disagree . I think it ' s inadequate and we ought to say so .

DR . SPEIZER : Yeah, I think I heard you , John, say something . You might want to repeat what you said . DR . SAMET : Well , I was trying to capture the
essence , Frank, of what our three commentors said and what , I think, in a sense the document says where this sentence -- 3

-25 , Given all the above , a favorite phrase , we conclude that consideration could be given to either retaining or revising the current1

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standard
-- indicating this , sort of , things are sort of equi

-handed in the two -- equi

-balanced in the two hands ; and I think that ' s what Wayne , Rogene and Ed said . So what is your point of view? I mean, Mort , I think, feels that the evidence is inadequate towards revision, is your comment .

DR . LIPPMANN : Well , the standard, current standard or its equivalent , if we talk about its equivalence of 87 or 85 , I think it ' s going to be inadequate to protect the public health .

DR . SAMET : Okay . I thought you were referring to the evidence . Okay . That ' s fine . So you ' re saying that the evidence in your view favors
--

DR . LIPPMANN : The evidence is sufficient . That we have a problem with the levels meeting the current standard producing effects .

DR . SAMET : Okay . Frank? DR . SPEIZER : Yeah, and I think that ' s where I ' m at as well . My concern is that the data that are presented that relates to 10 minus 2 . 5 fall in the suggestive category and that may move people toward saying, well , we aren ' t doing anything about it . On the other hand, there ' s data that ' s presented in some1

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-- presented that relates to PM10 says that the current standard is not adequate to protect . And therefore , since the PM10 is to represent -- we want it to represent , which is the coarse fraction , I think it says to me that we ' ve got to lower that standard .

DR . SAMET : Helen? DR . SUH : I think as a point of clarification

-- I was a little bit confused . My reading of that section was actually that there was a -- DR . SPEIZER : You ' re breaking up .

DR . SUR : In the document it says there was stronger evidence supporting for the retaining of the standard because my reading of it is the 85 level was presented as being comparable , given the 98th percentile , as being comparable to the current standard now --

DR . SPEIZER : I ' m only hearing every other word . DR . SUH : -- based on that
one-expected
-exceedance . So given that , I thought
-- and then given also it said the strongest evidence
was for the 85 micrograms per cubic meter , I read that section to read that it was really in favor of1

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-1896 (FAX) 176 changing the form of the standard but keeping the basic level of protection the same .

DR . JENKINS : Well , I think the characterization that the evidence , the decision, sort , of hangs in the balance , I think, is accurate . So I think in this section what we ' re saying is that depending on -- so any decision that ' s made on the adequacy of the current standard is obviously going to have to weigh the evidence against the inherent
uncertainties . So to the extent you place more weight on one versus the other , your decision could go one way or the other . So we don ' t come down firmly in one direction or the other in this section
on adequacy .

Now, in terms of the level
-- when we get there we can talk about it , but you ' re right that the upper end of that range of levels is

-- the way we characterize it is on average across the country equivalent to the current standard . So there are some -- if you look at the evidence , there are some reasons why it would make sense to set -- if we were to revise the standard, to set it at that upper end, again, depending on how much weight that you ' re placing on the evidence versus the uncertainties on different types of studies . In terms of just looking1

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at this adequacy section, we don ' t come down on one side or the other .

DR . SAMET : Sverre? I thought you had your hand up .Mort ?

DR . LIPPMANN : Well , clearly I would advocate going to the 98th percentile for stability reasons . But then my problem comes in with picking 8 5 versus something lower because the evidence is quite clear that this will be uneven across the country and that
some communities will have greater protection at 8 5 , 98th percentile compared to 100 , or 50 , 20 maximum, and others will have less , considerably less for
some . Now, that means that the standard is being relaxed for some considerable fraction of the U . S . population . And I don ' t think relaxing the standard, in my view

-- which apparently Frank endorses
-- that it ' s inadequate to protect against the effects of
coarse particles ; so how can you justify relaxing the standard, if not for the whole country, at least for
a significant part of the country?

Therefore , I come down with the need to go below 85 ; and in my written comments , I said something in the range of 65 to 7 5 should be the proposal . And as an incremental risk reduction1

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strategy for this round where the data are not as clean as we would like , I would be willing to live with 7 5 personally, but I don ' t think we should rule out 65 as a viable option for the protection of the public health as long as we ' re required to have national standards . If we could go to local standards that would be a different situation , but
we ' re not allowed to do that . So I don ' t see any justification for relaxing the degree of protection in the PM10 standard .

DR . SAMET : Scott and Karen, I have a question
a minute , and I think this might be helpful . I ' ve read what you wrote , but now I want to know what you were thinking . And I think this is particularly in regard to how you considered the fact that the evidence was at the suggestive level . I mean , it
seems to me , there ' s sort of two parts , two issues here . One is , are there adverse health effects , and is the population

-- I think this goes back to where Mort was -- is the population experiencing concentrations

-- exposures of concentrations at which there may be adverse health effects . So there ' s really two issues that are caught up in your determination of the adequacy . One is the strength of evidence for adverse health effects and then ,1

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additionally, the exposures that the population experiences ; and they both figure in to whether there ' s an adverse effect , the determination as to whether there ' s an adverse effect on public health .

So how did you think this through? And I think the precedent here is , in part , around how you handle these levels of evidence where the strength of evidence is , sort of, now down at the suggestive range where there ' s legitimately concern for public health but less certainty of evidence , in part , because we just don ' t have very much .

DR . MARTIN : Scott can clearly speak to some of that , but I would like to just jump in and comment
on something Dr . Lippmann said before getting into that question .

You alluded to the notion that if the form of the standard were to be revised to the 98th percentile we would see more unequal protection . I would be inclined to flip that around and say that when you base a standard on a very extreme statistic , like the one-expected
-exceedance , the consequence of that is to have relatively unequal degrees of protection ; and by moving to a 9 8th percentile you would tend to have more equal degree of protection
across the country . And if you pick it at a level1

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that is roughly equivalent , then , of course , some would be more protective , some would be less protective ; but one of the primary motivations to
move to a 98th percentile form, regardless of what level you set it at , is to get away from the very extreme statistic which results in a great deal of differing degrees of protection across areas . So I just wanted to offer that observation .

DR . LIPPMANN : Well , I said that as I started, that I endorse going to the 98th percentile . Then the question is , what do you do when you make that decision that the 9 8th percentile is the way to go . You have to pick a level . And that ' s where apparently I disagree somewhat with the subsequent decision as to what is the best level where the document suggested 85 is adequate , and there I end up disagreeing .

DR . SAMET : We are going to come back to this question . So why don ' t we leave this question for the moment . Is that okay, Phil , or do you have
--

DR . HOPKE : Right . But again, the question is what ' s the right indicator, and the point is that
we ' re arguing over the wrong indicator .

DR . SAMET : Okay . I promise you that we have
a question labeled indicator . Okay .1

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Back to the adequacy question, Scott . DR . JENKINS : Okay . Well , I mean , you ' re right that when we talk about uncertainties , we ' re not only talking about the types of uncertainties that we typically think of in terms of epidemiologic studies , we also have the broader uncertainties with the body of evidence associated with coarse particles . And frankly, that weighs in , not only in
our consideration of adequacy, but in our consideration of level , and we can talk about this when we get to level .

So obviously we have epi studies . We have single

-city analyses that were done . We have the Bayesian

-adjusted analyses from the Zanobetti and Schwartz study that have
-- where we see positive effect estimates , 10 minus 2 . 5 effect estimates in locations that would meet the PM10 standard . So how much weight do we put on those . Well , I mean , we have evidence in some locations that are considerably below the PM10 standard . So you know, if we had really strong experimental evidence , if we had a really strong overall database , then we might have
more confidence in some of those associations . We might be more willing, just conceptually, you might be more willing to push the standard lower to have1

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more confidence in a conclusion that the current standard ' s not adequate .

Given that we have the amount of uncertainty that we do have , that we have suggestive evidence for 10 minus 2 . 5 , you know, there ' s a logic , I think, to be made
-- a logical argument to be made that maybe you shouldn ' t put as much weight on some of those , the studies in the locations with really low concentrations .

So I mean , we have uncertainties all around, and one of the big ones that we ' re dealing with is this overall uncertainties associated with the body of evidence as reflected in the ISA judgment that the evidence is sufficient to suggest a causal relationship , but not a likely causal or causal .

DR . SAMET : I mean, I think that was helpful and I think we shouldn ' t be surprised that since the evidence is somewhere
-- I ' ll use a fancy word
-- around equipoise , that some people might view it one way and others possibly would view it another if we were to , sort of, explore the range of opinions around the table .

I think in terms of the comments that will
come from this group, I guess , Wayne , I guess the question is whether you , as you write this , need to1

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reflect the fact that there is uncertainty, and I think the document describes those sources of
uncertainty . Scott just framed them again . The evidence , if it hangs in the balance , might be viewed
as sufficient from the point of view of public health protection to move forward; and some might view the evidence as , in fact , indicating inadequacy of the current standard . So I think this will be important . Careful writing will be
-- will be needed to reflect where the science is and the range of views about where it is , the scientific evidence .

Do others want to weigh in on this ? I think it ' s an important issue .

Yeah, Helen . DR . SUH : I don ' t actually know if this is helpful , just a clarification before I start .

I was wondering if because the causality, it
was suggestive , the evidence was suggestive of a causal association, in your mind does that make that providing a margin of safety in and of itself because you ' re including

-- including evidence that is not -- there ' s a lot of uncertainties associated with it , so it ' s a suggestively causal , and is that determination sufficient to provide the margin of evidence in your mind

-- I mean the margin of safety in your mind?1

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DR . JENKINS : Well , I think

-- and Karen ' s hit
on this earlier . There ' s no real formula for how
-- determining exactly how to provide that margin of safety . But certainly in other reviews , and in the
case of the fine particles , when we look at the different bodies of evidence for different endpoints and the weight of evidence , judgments that have been made about them, we do look at suggestive evidence and we often look at it in terms of helping us to provide that margin of safety . But whether setting a standard based on that evidence by itself provides the margin of safety, I think is a different issue .

DR . SUH : This one is a little bit different because for coarse particles , nothing passed
-- I
mean , that was the highest level of
--

DR . JENKINS : Right . So I think what I ' m saying is it would be part of a decision on margin of safety; but whether it would be the whole decision , I
mean , I don ' t know .

DR . SAMET : Although, actually, I think I would be careful in a sense not to contaminate the assessment of the strength of evidence with considerations of margin of safety .

It seems to me that , Helen , your point would1

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be whether , in the face of uncertainty as to causation, action were taken to ensure possibly that given that there is a risk that protection is provided . I mean , it goes back . We heard Bradford Hill quoted this morning . His 19 65 paper ends with his famous quotation about how evidence is always accumulating and
-- something like that
-- always incomplete , and that does not mean that action should not be taken . And if the potential risks were judged to be sufficient , even in the face of suggestive evidence , perhaps , one might take action . But that ' s where the policy judgment comes in , I think . I mean , the assessment of the strength of evidence should be solely that , based on the strength of evidence without external potential policy considerations framing the evidence consideration to the extent that you can do such with people .

DR . SUH : I mean, I agree with your point . But the determination of causality was based on the scientific evidence . So the thing is this margin of safety is a really vague sort of undefined quantity, and I guess my question really went to is how does EPA view it ; whereas , when I was reading the document , I didn ' t view it that way at all . Then with the subsequent discussion , it made me think,1

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well , perhaps there ' s alternate ways to think of margin of safety than the way I had been thinking; and I was just wondering what the Agency had done .

DR . JENKINS : And I think that what we have been talking about for the last 15 minutes essentially gets at that issue that , you know, we talk about these uncertainties that were really the basis

-- part of the basis for those weight

-of
-evidence judgments in the ISA; and those
uncertainties are going to be considered in the way that ' s described in the document and the way we ' ve been talking about in terms of they ' re going to weigh
on the decisions on the adequacy, on the level if we were to revise it . So there will be
-- those
uncertainties that led to that suggestive judgment
are going to be incorporated into the overall decision including the consideration of margin of safety . PROF AVOL : So just to come full circle again, I think it ' s clear that there ' s some difference of opinion about what the bases of the arguments are . Some believe , some don ' t ; but I think the document has it right . The last sentence is , therefore , we judge it is appropriate to review the adequacy of the standards .1

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DR . SAMET : Okay . Other comments on 6 ? (No response . ) DR . SAMET : Then why don ' t we , even though it says after 6 we reward ourselves with break, we won ' t ; and let ' s go on to discuss question 7 , the indicator, which is Phil and Ted . Phil , this is just that , what are the Panel ' s views

--

DR . HOPKE : Right . Okay . 7 . DR . SAMET : Yeah . COMMENTS ON CHARGE QUESTION NO . 7 :

DR . HOPKE : So my feeling is that the PA is still pushing for continuing to use PM10 , and we obviously have lots of epidemiological evidence for PM10 ; but as we ' re all aware , PM10 is contaminated by PM2 . 5 where risks are substantially higher . And the point is we know how to measure PM10

-2 . 5 ; and so if
we ' re going to set standards for coarse particles , shouldn ' t we set standards for coarse particles and not coarse particles plus fine particles ? So my feeling is that it is time for us to move on, that you know
--

DR . LIPPMANN : Felt that last time . DR . HOPKE : Well , we felt that last time ; but the point is that Petros was right in 1996 when he suggested that in the first place . And you know,1

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-1896 (FAX) 188 continuing to stall around is not helping the situation . Do we have enough information that we ' re happy with PM10

-2 . 5, no . Do we have about the same amount of information as we did when we leaped off the cliff and instituted PM2 . 5 , I think we do . And so the question is , let ' s hold hands and jump .

DR . SAMET : Ted, can you top that ? DR . RUSSELL : Maybe I ' m just not ready to hold hands and jump like Phil .

So I probably come down with we ' ve got the information on PM10 . I think the reasoning that they used for the PM10 , to stay with PM10 at this point , is appropriate . I mean, yes , I would love it if we had all this PM10

-2 . 5 data , you know, and some compositional information . But at this point , I would stay more comfortable with PM10 in terms of what standard we might choose . So I think I ' m just not jumping quite so quickly as Phil .

DR . HOPKE : Well , then we have the problem of the grossly uneven level of protection it presents with respect to coarse particles across the United States . And the only way we ' re going to have an even level of protection is to have a standard which, in fact , measures that which we think is causing health effects or an overly restricted standard which forces1

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excessive measures of control in areas that don ' t need it .DR . SAMET : Sverre?

DR . VEDAL : Intellectually I ' m in favor of what Phil has said . It just makes so much more sense to be actually measuring and controlling the metric that we ' re actually
-- of interest here .

I don ' t agree with his second part . The problem with

-- there ' s an issue with having a pure coarse standard and having a national standard at the
same time . A coarse standard exacerbates national disparities more than a PM10 standard does , which we already know has national regional disparities .

So I ' m torn . You know, intellectually, I -- DR . HOPKE : Would you explain that to me? I don ' t understand . I really don ' t .

DR . VEDAL : Well , all right . So we know PM10 is penalizing places that have more coarse particles
or higher coarse particles because they have higher PM10 because of that . When you focus just on the
coarse fraction , those places are going to be even worse relative to places that have a predominance of PM2 . 5 ; right? You ' re going to have
--

DR . HOPKE : But if coarse particles are bad, then how is

--1

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DR . VEDAL : Ah, but why are they bad? That ' s the issue . So you ' re going to be penalizing places that have dust , coarse PM; right ? And they ' re going to have a lot more coarse PM than places that have what we might argue would be more toxic coarse PM .

DR . HOPKE : And we know that in the same way we know about the species in PM2 . 5 where we have 10 years of speciation data and still can ' t figure it out? DR . VEDAL : Uh, no . But I ' m not willing to take that step to penalize places in the country where the composition of PM is largely crustal relative to places where the composition is not crustal . I mean, you ' re saying, you know
--

DR . HOPKE : You ' ll penalize the other ones then . DR . VEDAL : No . You ' re already penalizing places that have more crustal PM based on the PM10 standard . You ' re just penalizing them less than you would if you had a coarse standard .

DR . HOPKE : You ' re still making the assumption that the places that definitively have more coarse particles

--

DR . VEDAL : No , I don ' t think I ' m being definitive about that . I ' m being

--1

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DR . HOPKE : -- are ones that have coarse particles with less health effects , and I think that ' s a very risky assumption .

DR . VEDAL : No . If I wanted to maintain that , I ' d do something different ; but I think it ' s safer , given the evidence that we have , to rely on a PM10 standard .

Now, I mean , I don ' t like a lot of the arguments that are being made here to support using PM10 . I don ' t think, for example , in this one plot where we ' ve got these ratios of PM10 to PM coarse and how it changes at the upper end of the distribution with the conclusion that across much of the U . S . , you know, elevations in PM10 are due in large part to the
coarse fraction . I think that ' s an overstatement . Even at the higher concentrations it ' s 55 percent of the PM10 mass . But having said that , I ' m still not willing to do , I think, what in essence amounts to exacerbating the current situation which

-- with respect to PM10 , which is not a good one because of the regional disparities .

DR . SAMET : Okay . Rich? MR . POIROT : Well , I was just remembering the last time around when the , sort of , alternative way of trying to somewhat address the same issue was the1

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concept of try and define urban coarse particles
versus non-urban coarse particles ; and I was one of the dissenting few that didn ' t think we should try to make that distinction because I didn ' t think we could logically do it with reasonable monitoring guidelines and that sort of thing . So this seems to me to be a little bit of an attempt to kind of do the same thing by somewhat more devious means .

It ' s clearly stated in the document that that ' s an intention of using PM10 , is that in urban
areas a higher fraction of the PM10 will be fine and, therefore , the effective coarse particle limitation in urban areas will be lower , if I read the document correctly, than it would be in more rural areas where all of the
-- most of the PM -- almost all of the PM10 is coarse . So given the choice of trying to call it urban versus non-urban coarse particles , I think I like this approach better for the present time .

DR . SAMET : Helen? DR . SUH : Well , since Frank isn ' t here , and I ' d like

-- several meetings ago he had suggested
-- and I ' m just going to bring it up now for a further discussion

-- it ' s possible to have three
-- to regulate PM10 and coarse , you have three indicators , the PM2 . 5, the coarse , and the PM10 . You brought that1

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up in the last time . I think several sessions ago we had a similar discussion about the indicator . And I
mean , I agree with Sverre and you that I think it intellectually makes much more sense to regulate what you ' re trying to regulate . So it makes much more sense to have coarse particles being the indicator . But given all of the other issues and all the considerations , Frank, I remember brought up -- Frank, are you still there ?

DR . SPEIZER : I ' m still here . I ' m trying to remember what I said .

DR . SUH : He brought up several times ago the idea of having three to sort of get around some of these issues and some of these areas . And I don ' t know practically how that could work out , but it is maybe something to think about .

DR . SAMET : Frank, are you there? DR . SPEIZER : I ' m here . I ' m trying to remember what I said .

DR . SAMET : Well , maybe Helen remembered it better than you will .

DR . SPEIZER : She ' s younger . DR . SAMET : Do you want to comment on this issue? DR . SPEIZER : Well , you know, the concern I1

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have is that we don ' t have
-- I don ' t think we have sufficient data to be able to , sort of, battle the battle that will have to be fought for PM10

-2 . 5 direct health effects , that suggestive data ; but we ' ve got
an overwhelming supply of PM10 data . Now, how we resolve that , I just

-- I mean , I think it would be nice if we could go to PM10

-2 . 5, but I think we ' d have trouble defending it .

DR . SAMET : Just a comment , remembering 19 9 6 , I guess along with Phil , where at that moment PM10 was , of course , telling us about PM2 . 5, which was the indicator that we were going to move to to deal with fine particles , roughly, with very limited health data coming directly from PM2 . 5 . Yeah?

DR . HOPKE : How is it different now? DR . SAMET : Yes . There was very limited data, and in some ways here the question ' s a little more complex about the size cut and the biology . I mean, here at this point , at least , there is an interest in this particular size fraction . Then the question is whether it ' s ready to be measured directly or to continue with a surrogate that is a variably valid surrogate across the country with these other issues captured .

I guess the other point in this sentence of1

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3

-29 , we further conclude that consideration of alternative indicators (e . g . PM10

-2 . 5)
-- this is at the top of the page -- in future reviews is desirable and could be informed by additional research as described below ( section 3 . 4 )
-- I think you actually
mean section 3 . 5 .

And I mean, you know, there it says things like study PM10

-2 . 5, but that ' s not going to come on a very rapid time frame . And even thinking about five years -- this goes back to Vanessa ' s point earlier about taking a more broad and integrated look at this

-- at the issue . I ' m not sure that this
so-called new research will move anything forward on the coarse mass on the five

-year time frame , and I don ' t know about the ten-year .

So we ' ll do Mort and then come back to you Scott . Mort ?

DR . LIPPMANN : I ' ll take you back further in time . Go back to the mid

- 19 8 0 s when we made the leap off the cliff to go to PM10 as opposed to something called total suspended particulate , which it never was , and there was extremely limited data . In fact , you had to look at monitoring data from the limited research studies and come up with something equivalent at that point to give protection .1

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The mistake EPA made was switching from the dichot to the single filter . I f it kept using the dichot and sharpened it up and improved it , we ' d have lots of data now, and that ' s really
-- and it ' s probably not too late to consider going back for something like that . In fact , to the extent that there are networks of continuous monitors going into place , they should be a dichot version so that you can continuously monitor automatically co-located samples . They ' d be in the same housing, and so that ' s something in the broader context of advances in gaining information that needs to be considered .

On the other hand, I think for practical
reasons I ' d be willing to stick with PM10 as the indicator in this round, this late stage of this round for the reasons that the document supports . But my enthusiasm is limited and it ' s conditioned on getting to something better for the next round .

DR . SAMET : Scott , did you want to -- DR . JENKINS : I just wanted to remind everyone that we did finalize an FRM for 10 minus 2 . 5 in the last review and we do expect those monitors to be up and running by the end of this year . I don ' t know if Joann and Tim can comment on this .

DR . HOPKE : Yeah, except it ' s the wrong FRM .1

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That ' s a case where you made up your mind and then ignored our advice .

DR . VEDAL : And I ' m not sure I would be quite
as pessimistic about in future research on the coarse fraction as you paint it . You know, there are a number of studies coming down the pike that are focusing on the coarse fraction that we should have information on well within this , sort of, five

-year time frame .

DR . SAMET : Okay . Vanessa wants to tell you -- she thinks we ' re past the
-- let ' s try and see if we can close out the one indicator before we take
a break . We can come back and revisit .

I think we ' ve heard a range -- I will say a range of opinions from leap off the cliff to don ' t leap off the cliff to there are pragmatic reasons to stick with PM10 , which I think is sort of the dominant weight of the arguments in the document .

Anybody else who has not expressed a point of view who wants to comment here ?

DR . HENDERSON : I would like to ask a question of the EPA . If you set the indicator as PM10

-2 . 5, if
we leaped off the cliff

-- I mean, could you do that ? Do you have enough information to even see if the standard was being met?1

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DR . JENKINS : Well , we do have some co-located monitors , PM10 and PM2 . 5 monitors . There are issues with the sampling protocols in terms of the consistency between the two types of monitors . So just for perspective , thinking back to the ISA, and I
can ' t remember the numbers of monitors , but the PM10 network, for example , the fine particle network, for example , covered something like 40 to 50 percent of the population in the cities that were evaluated . And if you look at the co-located monitors , you use the same sampling protocols . It was something like less than five percent of the population . So it ' s a really limited number of co-located monitors in terms of the population coverage .

So the answer to your question is I ' m not sure off the top of my head . And Tim may want to add something to that .

MR . HANLEY : I think the thing I want to add is that whatever the CASAC decides in terms of recommendations back to the Agency on setting the standard, that ' s one issue and that ' s separate from the logistics of the monitoring network . In the logistics of the monitoring network, I think the point I want to bring up is that when you think of PM2 . 5, they tend to be at neighborhood scale ; and when1

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you think of PM10 , they tend to be at middle scale . That ' s why we don ' t have this largely one-to-one relationship between PM10 and PM2 . 5 monitoring .

But there ' s no issue if the Agency were to choose to implement a PM10

-2 . 5 network as a result of this review, there would be no issue with setting that standard up from a technology standpoint . The technology exists . And, you know, if Bob Vanderpool
were in the room, he ' d be telling us how great dichots and FRM ' s actually compare to each other, and he has a study on that or a report that he ' ll be making available . But you know, separate out the technology from the need . The technology ' s there .

MR . MOORE : John, can I just

-- DR . SAMET : Yeah, Tom . MR . MOORE : Can you just define

-- because you used two terms , neighborhood and middle . Can you just define those so everybody knows what you ' re talking about?

MR . HANLEY : Sure . Thanks , Tom . So when you think of neighborhood scale , you ' re thinking of dimensions

-- I think it ' s from about a half a kilometer to four kilometers , is kind of the canned language we use in the regulation . And you ' re thinking of areas in a city that are1

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-1896 (FAX) 200 relatively homogenous across the city .

When you ' re thinking of middle scale you ' re thinking of areas that are on the order of, I think it ' s , like , about a hundred meters to half a kilometer and you ' re thinking of , sort of , peak concentrations where there would be locations in addition to the fine particles , the increment of true
coarse particles that are causing that location to , in fact , have exposures of a substantially higher concentration .

So the design of the network is , in fact , different ; and if we choose to go down this route , we would address that in the monitoring design . But again, that can be done . We ' ll never get a hundred percent co-location . And if EPA were to do this with the states , we would offer some flexibility to the states on which designs because Joann just reminded
me that we have approved dichots now for 10 minus 2 . 5 and we have approved upper ends for 10 minus 2 . 5 .

So there ' s some flexibility . And again , the technology ' s there , but the design of where we site would be a little bit different unless you as a group spoke to that and insisted on something .

DR . JENKINS : And just to make one clarification just to make sure everyone ' s on the1

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same page , the availability of the technology is one issue . The availability of existing data on which we would base a 10 minus 2 . 5 standard right now is another issue .

DR . BRAIN : Can we have our cake and eat it , too? Why don ' t we affirm the PM10 standard, but also say that as rapidly as possible EPA should deploy dichots and begin accumulating direct data on the
coarse fraction .

DR . SAMET : Well , they did make comment -- I guess it ' s two thousand
-- by 2011 that the NCore sites

--

DR . JENKINS : That ' s right . DR . SAMET : -- that will happen . Ted, do you have any comments on this ? DR . RUSSELL : On what , main question? DR . SAMET : No , this one , the indicator question .

DR . RUSSELL : In terms of
-- DR . SAMET : Mic on, put your mic on . DR . RUSSELL : Oh, sorry . In terms of what ' s viable or in terms of
-- I think as I said to Phil , is that I ' m just not ready to -- I think we have the technology to do the measurements and all of that . That ' s not a problem .1

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I just don ' t think that we have the
-- I probably fall in Sverre ' s and, well , definitely Richard ' s camp , that I prefer this versus -- going this approach versus trying to say that urban PM is

-- PM
coarse is harmful whereas rural PM coarse is not .

So were you asking that or versus the technologies and measurements ? I wasn ' t sure .

DR . SAMET : I think both because they are caught up with each other in part , so .

DR . RUSSELL : No , I mean , in terms of monitoring, we will be able to do it . I don ' t think that ' s a problem down the road, but I don ' t think we have the database currently . It ' s not nearly so strong as the PM10 . So I don ' t think I ' m answering your question .

DR . SAMET : Well , let ' s go back just to wrap up , and I think we ' ll take a break and maybe revisit .

Phil , I mean, if you were writing the comment , you would say it is time for the Agency to jump off the cliff .

DR . HOPKE : No . Again , I mean , if I ' m outvoted, I can write something that reflects the committee . But I mean, my personal feeling is that at this point we know enough relative to where we ' ve been with other kinds of standard
-setting processes1

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to say that we should be fixing our attention on that pollutant for which we have decided there is a need for control and not for something where we can ' t -- where we ' re inferring what that coarse particle is based on a measurement which includes a variable amount of some other pollutant which we know is more toxic in general .

DR . SAMET : So I think it would be fair to , with this discussion

-- and I think this is at least my view of what I ' ve heard and part of what I ' ve read is that the evidence , from the technological standpoint , making the measurements is possible . The method is going to be implemented . And really, the question is , if now is not the right moment for making the switch, it is very soon that it should be made . DR . HOPKE : Well , it just shows you epidemiologists are getting greedy in your old age and you want too much data .

DR . SPEIZER : Maybe in my old age I ' m becoming
more -- DR . SAMET : In whose old age ?

Let ' s see , yeah, Rich . MR . POIROT : To add to Joe ' s recommendation , we sort of are talking like we ' re standing on the1

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verge of this dawn of the great new age and we ' ll have all this very helpful new PM coarse data in the very near future . I think it would be very important for us to advocate the importance of that ; but in doing that , I really think we may not actually be in
a position , once we have that new PM-coarse-mass only data , to actually get back to the heart of the problem of the relative toxicity of different kinds of coarse particles . So to me , the speciation and other kinds of information about the coarse particle is as important as the mass .

DR . HOPKE : Well , we can get to that with the key uncertainties . But I mean , one of the big problems there is that you now need to also be looking at things which we cannot look at in terms of
a large
-term network like primary biologicals .

DR . SAMET : Okay . Sverre , last word before break . DR . VEDAL : Just a small word . The studies that I ' m alluding to that were funded by EPA, the next wave of studies , actually has a focus on coarse PM speciation, including biologicals . And I don ' t want to be a child in the woods and appear overly naive , but I think there ' s a prospect that we ' re going to learn some substantial things from those1

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studies .DR . SAMET : Okay . A 15
-minute break .

(Recess taken 3 : 01 p . m . - 3 : 20 p . m . ) DR . SAMET : We ' re back . Frank, are you with
us ? DR . SPEIZER : I ' m with you .

DR . SAMET : Okay . Good . Before break we were on indicator; and we had, I think, a discussion that covered a wide range of
-- well , there ' s only two points , there ' s only two options , really, I guess , the jump

-off
-the
-cliff option or not-to-jump

-off
-the
-cliff option for the moment ; and the issue is one of timing . So just on this

-- you know, I ' m actually going to suggest that
we move on to form and that , of course -- I mean, all these run together . So yeah .

DR . WEATHERS : May I ask a question before you do that?

DR . SAMET : Sure . DR . WEATHERS : I ' m luckily not encumbered by history here , so I wanted a bit of clarification . The jump

-off
-the
-cliff version was advocated in part because that ' s what happened in the past , and I just wondered whether there ' s a difference in the policy environment now . If there ' s not --1

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DR . HOPKE : Well
-- DR . WEATHER : If there ' s different

-- DR . HOPKE : -- we made the judgment in 19 9 6 that even given the high degree of uncertainty because of the limited number of studies , there was sufficient compelling evidence that we should go head with the PM2 . 5 standard .

DR . WEATHERS : Right . Yeah, I understand the argument .

DR . HOPKE : Now, in nineteen

-- in 2006 , we also agreed there should be a coarse particle standard, although we got hung up on this urban/rural mixup that unfortunately we weren ' t able to ever dodge around and so that got us into severe troubles because we really didn ' t have any information on the relative toxicity of urban and coarse in a way that made it possible to distinguish one from the other . But the recommendation that went forward in the setting of the 2006 standard was to set a coarse particle standard . So we are in fact backsliding in this round .

DR . WEATHERS : Right . But what I thought I understood was that you were going down a parallel argument line , so that we don ' t currently have any more or less data than you had in the past to make a1

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decision .

DR . HOPKE : I think we probably have slightly
more data than we did with the PM2 . 5 on PM coarse and
we ' re in a position that we could say we would be better off
-- again , because of the known problem of differing amounts of PM2 . 5 for a given amount of PM10 , it means our current standard is unequally protective of the onsite coarse fraction . So the argument there , should we be measuring that which we think is driving that set of health effects .

DR . WEATHERS : Right . But my question, though, is has the policy environment changed . So the requirements for jumping off the cliff from a data standpoint seem not to have changed, at least from some perspective ; but has the policy environment changed .DR . HOPKE : I expect this administration would look at these issues in a somewhat different manner than the prior administration .

DR . SPEIZER : Well , it was the prior administration in ' 96 , so .

Phil , do you recall whether or not in ' 9 6

-- and I ' m thinking in terms of
-- what I can think of in terms of ' 96 , was Dockery, et al . , whether we had
more than suggestive data that 2 . 5 is dangerous ?1

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DR . HOPKE : Again , we had
-- no . Because again, there was all the arguments about the way the statistics were done because you were looking at the differential of effects per unit , mass against mass giving you this straight

-line behavior .

So one of the arguments that George Wolff gave me as to why I should get on to the CASAC was , you know, you ' ve got all these epi people doing strange statistics to try to come up with justifying PM2 . 5 . So no , I don ' t think, you know, there was any firmer ground back then than the quicksand we ' re treading
now . DR . SAMET : But Phil , I mean , I want to remind you as possibly one of those strange epi people that , I mean , in both cases there ' s strong grounding and, sort of, knowledge of where these particles go and where they deposit . I mean, in both cases you can make very rational , compelling dose , et cetera, driven arguments , and I think equally in ' 9 6 and now, PM2 . 5 then, PM10

-2 . 5 now .

DR . HOPKE : Right . DR . SAMET : So I mean, it just seems to me , while everything should be grounded in epidemiology, there are certainly many other considerations . That
was a joke , by the way about the
-- I mean, just

--1

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DR . HOPKE : Right . So I think it ' s a pretty parallel situation .

DR . SAMET : Yeah, I agree . Okay . So we ' re going to move on to form and, I guess , this is , of course , a little bit complicated by indicator . But Phil

--

DR . HOPKE : And level . DR . SAMET : And level . So it ' s almost hard to separate -- sort of , it ' s hard to separate 7 , 8 and 9 in any way . COMMENTS ON CHARGE QUESTION NO . 8 :

DR . HOPKE : Again , let me provide some quick history . I got into this game in 19 8 1 , when the American Iron & Steel Institute wanted me to look at the form of the standard, which resulted in this ' 8 4 paper that I reference in my comments , in order to try and get the EPA to set a 9 8 percentile level at the same concentration as the expected exceedance level , which would, of course , weaken the standard .

Now, the point is that the percentile standard is a much more robust statistical approach in terms of at a given 90 percentile value you get much better power, you get lower Type 1 error . So in terms of both being protective of public health at the level you choose to have and the probability of1

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misclassifying an attainment area as non-attainment , the percentile standard works much better . Now, the key then is how many of those exceedances are you going to -- or you know, exceedances of what value
are you going to have in order to have the distribution have the kind of reduction in health effects that you really want .

So there ' s an interaction here or an interplay between the level and the form of the standard that becomes important when you ' re trying to recognize a given level of risk reduction, but that still doesn ' t
mean that the 9 8th percentile is less protective . It is in fact more protective because it has higher power as demonstrated in this ' 84 paper . So I really would push very heavily that a 9 8th percentile standard is a good one .

Now, why 98th and not 9 9th? Well , the biggest problem we have is , again, back to our monitoring program . When you only measure every third day, you don ' t have a whole lot of samples . And if you don ' t have a whole lot of samples , that makes the 9 9th percentile harder to determine than the 9 8th percentile because there ' s fewer samples . So again, one of the things that may need to be revisited is if
we get a more complete monitoring system so that we1

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have complete data then we ' re better off getting to higher percentiles . Expected exceedance only works better if you have more than 331 days a year that you have monitoring data for, and we simply don ' t do that . DR . MALM : Question .

DR . SAMET : Yeah, Bill . DR . MALM : Did you look at the
-- everything you said is precluded on assuming, like , a log
-normal size or a log
-normal distribution or something of that sort if you had a --

DR . HOPKE : No . We looked at log
-normal . We looked at exponential . We looked at Weibull . So it holds for a variety of positively skewed heavy
-tailed distributions .

DR . MALM : But not for bimodal ? DR . HOPKE : Hmm? DR . MALM : But not for bimodal ? DR . HOPKE : No . DR . MALM : And you didn ' t consider

-- did you look at real data
--

DR . HOPKE : Yeah . DR . MALM : -- across the
-- yeah, okay . DR . HOPKE : I mean, the paper only deals with models , but
--1

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DR . MALM : Yeah . DR . HOPKE : -- with simulations . But no , we looked at a lot of real data .

DR . MALM : Yeah . DR . SAMET : So Phil , your comment in general is the 9 8th percentile for form?

DR . HOPKE : Yeah . DR . SAMET : Okay . Ted? DR . RUSSELL : I generally agree . Actually, picking up on something else Phil said . You were talking about using the 9 8th percentile of a three
-year distribution versus the average of the 98th percentile over three years , one being preferable over the other . The point I would make is that it should be consistent across all of the various pollutants involved, particularly if we look at PM coarse . In some ways what we ' re looking at right now is that
-- with the current recommendation, we ' re sort of looking at equivalent PM coarse of 50 micrograms per meter cubed, is what they ' re -- you know, 85 minus 35 . And if you change the form between them, you wouldn ' t have that same equivalency .

So I like the 9 8th percentile ; and I ' d make the point that whatever they do , it should be1

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consistent across all the pollutants , and I ' d say even ozone in terms of averaging out and such, so . I like the way they ' re proposing at this point .

DR . SAMET : Okay . So this was form . I mean, this will feed immediately into level .

Helen? DR . SUH : I just wanted to comment a little bit about the form if I could just before . One of the things I think that goes to an earlier discussion
we had about monitor placement and also sampling frequency, given the greater spatial heterogeneity of the coarse particles and also the greater peakiness of coarse particles , I wonder if it makes sense to discuss the impacts of those two items on , maybe , monitor placement or sampling frequency . For example , peakiness , maybe it might argue to do a more frequent monitoring schedule other than one in six and one in three to be able to get a good representation of what that 98th percentile might be .

And then the other thing is I liked your Figure 3

-7 , which is similar to this , I think, ( indicating Figure 2

- 10 on display) similar idea; but I was wondering if you could also color code it as well to the regions . And that might get into some of the issues people talk about , about the
-- the three1

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-1896 (FAX) 214 point

-- basically, whether or not the
-- you know, when you say on average the 98th percentile and the
one-expected
-exceedance will be equivalent at that 87 level . So it might be good to show how it might vary by region .

DR . ASHBAUGH : I would second that color
-coding comment . I thought the same thing when I read that diagram .

DR . SAMET : Okay . Other comments on form? (No response . ) DR . SAMET : Okay . So why don ' t we go to level . Helen? COMMENTS ON CHARGE QUESTION NO . 9 :

DR . SUH : Okay . So we talked about this already actually, quite a bit .

Basically, there were two alternatives proposed, maybe three depending on how you count . One was to keep the standard the same . In terms of level it was the 85 micrograms per cubic meter versus the 65 . And I guess with the
-- I guess the major difference

-- this is my understanding from before
-- is that the 85 was meant to be somewhat equivalent to the previous standard . And given the
one-expected
-exceedance , it was sort of matched up on1

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average , was the idea . Then also , the difference with the 65 was that it included, really, consideration of only the studies that have a positive statistically significant impact

-- I mean, effect ; whereas , the 65 was basically incorporating other studies that had the
-- a positive but not statistically significant impact ; is that correct , pretty much the major difference between the two?

MR . HANLEY : Yeah, that ' s essentially correct . 87 was actually the point of rough equivalence ; but 85 , generally equivalent and also maintaining

-- we point out we would expect it to maintain PM concentrations below those in locations where studies had reported positive and significant effects .

DR . SUH : Yeah . I mean, I guess the way it
was set up it seemed that it was stated that the major evidence was to -- generally supported the 8 5 standard . However, in the way it was written , and also with the follow
-up with this alternative 65 standard, it really presented the evidence in such a way that the 85 wouldn ' t provide sufficient margin of safety . That was my interpretation .

So from the reading

-- and this is why I asked about the definition of margin of safety
-- it seemed to me that the 85 would not provide the margin of1

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-1896 (FAX) 216 safety given the fact that it didn ' t take into fact all these issues related to exposure error, for example . So that ' s why you might see a positive impact but not statistically significant . And so those issues would contribute , I would think, to a margin

-of
-safety consideration , which would argue to have , somewhere in that lower
-- between the 65 and 85 level instead . And so from that reading of it , it seemed that the 8 5 was not really going to be sufficiently protective .

DR . RUSSELL : And another consideration I think you have to look at here is that as you decrease the PM2 . 5 -- currently you ' re suggesting the 85 is about equivalent to about 150 ; but if you decrease the PM2 . 5 without also decreasing the PM10 , you ' re actually allowing more PM coarse . So I think in some ways I started looking at it is that right
now if you ' re talking about a 35 , 24

-hour standard for PM2 . 5 and an 85 for PM10 , that ' s roughly a difference of 50 . So if you were to go to 30 , you would probably want to equivalently go to 8 0 . But actually, even if you have the annual standard as the controlling one for PM fine or PM2 . 5, when you start reducing the PM fine , if you don ' t have a tighter PM
coarse or a PM10 , you are indeed allowing more PM1

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coarse out there . So I think that ' s another reason to consider a finer or a tighter PM coarse standard .

So I think that and also , there is a point that I think, again , looking at the tables you provided that an 85 microgram per meter cubed really doesn ' t lead to as much control as the 150 does . So you know, but I ' d like to see more of that analysis .

DR . SAMET : Rich? MR . POIROT : Most of this ground has been covered and the comments that I wanted to make have already been raised for the most part .

Just to add a little bit to what Helen said, and I completely agree with everything she said, is that , you know, there seem to be two ways -- two ways of supporting the upper end of the proposed range . One is this so-called equivalency test , and that ' s based on another scatter plot . I don ' t know if we can bring that up . It ' s one that scatters the expected
-exceedance form average over three years versus the 9 8th percentile .

DR . HOPKE : 3

-7 , Figure 3

-7 . MR . POIROT : And it includes a regression line . DR . HOPKE : Page 3

-39 .

MR . POIROT : Maybe we ' ll just wait for it .1

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( Figure 3

-7 displayed . ) MR . POIROT : It includes a regression line , and then the point where that regression line

-- which in my opinion , doesn ' t really describe the data very well
-- crosses the 150

-expected
-exceedance line is about 85 , actually 87 ; And that ' s then taken as the point of equivalency . But actually, it ' s a range from about 30 to 130 for the 9 8th percentile , that that is equivalent to that one-expected exceedance . So even the language that ' s used in the text to describe that is something, like , on average across the country; and I don ' t actually believe that that language actually describes the intersection of the regression line with the 150 level .

There ' s a table in one of the appendices , Appendix 3A, that shows , among other things , the fraction of counties that would be protected and the populations that would be protected given the current expected
-exceedance form versus the alternative range of different alternative 98th percentile forms .

If you actually asked the question at what 98th percentile level would the population protected be most similar to the population that ' s currently protected, the answer is at 7 5 . So if you ' re going for equivalency, I would say an equivalent population1

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-1896 (FAX) 219 protected is more equivalent than the intersection of the regression line . So it ' s just a point again that others have made that I ' ll try to make a little differently there .

The other argument that was used to help justify the upper end was , I think, the observation that of all the single

-city positive and statistically significant mortality results , none had 98 percentile concentrations above
-- or below that level ; and that therefore , that would be another way to support this as an upper bound to the range . And I guess I can ' t fault that , really . I don ' t think this is a terrible range , by the way . It seems reasonable to me .

But on the other hand, there are so many factors relating to coarse particle measurements . They ' re not measured very precisely . When you do
measure them, the spatial representativeness is limited, as others have pointed out . And then indoor/outdoor relationships are further confounding, all of which tends to push everything towards the null hypothesis in epi work . It ' s not like noise . It ' s actually pushing all in one direction .

Again, to sort of
-- I kind of like the argument towards the lower end, to give some1

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consideration to those studies that are pretty consistently positive associations but which don ' t quite pass significance tests is consistent to me with the margin of safety . So those were my comments
on the range .

Overall , I didn ' t think it was that bad a choice . You don ' t have a lot of material to work with . It ' s a pretty reasonable range . Maybe knock down the upper end a little bit for reasons others have stated .

DR . SAMET : Mort? DR . LIPPMANN : Yeah . My logic in jumping ahead earlier with comments on this was the Figure 3

-7 , that blue arrowhead that broadens as it goes ; but both Ted and Richard have given good supporting arguments for lowering it .

It ' s quite clear that PM2 . 5 is trending down because of the controls of sulfur and now the perhaps
new diesel engine that will come out will further lower the soot levels in the atmosphere , which means that there ' s more -- if fine particle levels are going down , then the coarse particle levels should
come down at least proportionately .

And I ' m glad Richard pointed out the 7 5 percent . If you look at the data, really, 7 51

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-1896 (FAX) 221 micrograms is really more equivalent to the 150 aside from the argument I made before that a lot of the country would be under
-protected at the equivalent , whether it ' s 85 or 7 5 . And so that ' s why I was pushing for suggesting that the range should not be 85 to 65 , with 85 being preferred, but 7 5 at most with 65 being a more protective level .

DR . SAMET : Okay . Other comments on this ? Tom, are you --

MR . MOORE : I ' m biting my tongue . But I just want to understand with the level where we want to be in five years . So if we pick a level for the coarse side , that will have one effect , I ' ve heard people say; and if we stay with PM10 level , a higher number, that will have a different effect . And I ' m just wondering whether that ' s part of the implementation discussion that we ' re not going to have or do we have
-- is this sort of a thing we should speak to in the letter that says , here ' s the choices that you ' re making by going with this indicator at this level
versus this other indicator at a different level because I think the strategies to reduce coarse material are pretty well known . They ' re quite expensive to do , and so I ' m wondering whether people want to tie that to some progress the next time1

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there ' s a NAAQS review for this indicator .

DR . SAMET : Mort? DR . LIPPMANN : I ' ll take a little different cut of where we ' ll be in five years . I think we ' ll be like we are now with PM2 . 5 annual . 15 seems like a step in the right direction, and now we understand it
wasn ' t far enough . So I think in that context , where
we ' ll be , where I would guess we ' ll be in five years , we ' re saying, it ' s a good thing we lowered it to 7 5 because now we have evidence five years later that 7 5 isn ' t sufficiently protective .

DR . SAMET : Let ' s see , Helen , then Rich . Turn your -- yeah . Thanks .

Okay . But I think your question is perhaps relevant also in the context of this broader discussion that we ' ve proposed and how might this all
come together . So let me try and recap on 6 , 7 , 8 and 9 . It ' s been an interesting discussion . We had the discussion on 6 about the question of whether the evidence , quote , "hangs in the balance" on adequacy . And I think a range of views across the committee , which I think is not unreasonable given where they
-- where the strength of evidence lies .

I think on this interrelated set of questions ,1

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7 , 8 and 9 , we heard that eventually there will need to be a move to PM10

-2 . 5 as the indicator; and the timing of that is soon, tomorrow for some in this
room and perhaps a little bit delayed for others .

I did hear full agreement on the 98th percentile , unless somebody wants to change their mind, that that was the right indicator

-- I ' m sorry form . And then on terms of level , that a lower
-- towards the lower range was what was needed in terms of health protection for the values of PM10 that were specified . So I think that captures more or less what the discussion was .

Does anybody want to add? Again, we have time
on our hands . Rich?

DR . SPEIZER : John, this is Frank . If we were to lean toward a 10 minus 2 . 5 at 65 to 7 5 and you add to that 10 to 12

-- 13 , for PM2 . 5, we are in a range which, sort of , I think most people would be comfortable with . Now, the question is can we see it that way? Can we set a 10 minus 2 . 5 somewhere between 65 and 7 5 and have the country not go crazy over how that relates to what was 150 PM2 . 5 . And I think what I ' m saying is , what is the acceptable range of the percent of PM10 as it falls1

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within 10 minus 2 . 5 ?

DR . LIPPMANN : Frank, this is Mort . We ' re talking about PM10 in the range of 65

-75 , not PM10

-2 . 5 . So if you want to talk about PM10

-2 . 5 --

DR . SPEIZER : Speak up . DR . LIPPMANN : -- then you would take the 65
-7 5 and subtract the
-- what , 30 .

DR . HOPKE : 35 . DR . LIPPMANN : 35 . If you wanted to go that way, it would be a number in the 40s . I ' m not disputing where you ' re getting, but you picked the wrong concentration range .

DR . SPEIZER : I ' m sorry . I couldn ' t hear any of that .DR . LIPPMANN : I ' m looking toward John and speaking not into the microphone .

I ' m saying we ' ve been talking about 65
-7 5 for PM10 not for PM10

-2 . 5 . So you ' d have to take that 65

-75 and subtract 30 or 35 from it if you wanted to talk about picking a number for PM10

-2 . 5 .

DR . SAMET : Rich? DR . SPEIZER : Well , you ' d really have to -- MR . POIROT : I ' m reluctant to mention this , just to throw out kind of an idea; but I was talking the other day to George Allen about coarse particle1

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data from the northeast . And he was commenting that it ' s remarkable in the sense that it ' s one of the most normally distributed of all pollutants . But this is from the narrow perspective of looking probably at urban areas in the northeast where we don ' t have a lot of windblown dust and that sort of thing . And yet , when we look at other aspects of the distribution of the coarse particles , they appear to be quite extremely episodic ; and that may reflect to
a certain degree on the different kinds of emission
sources . And I would certainly expect the windblown dust to be an extremely episodic kind of a source .

So therefore , if we were interested in focusing more on the urban so-called kinds of coarse particles , then possibly some consideration might be given to a somewhat lower percentile that would be less responsive to the episodic emissions , which are more characteristic , I would guess , of natural
sources than just

-- like I said, I don ' t want to push that . I just thought I ' d put the idea on the table . DR . LIPPMANN : I suspect that George Allen ' s data are at sites not that close to major highways by design . So you get much higher levels in the northeast if you went near an interstate or a major1

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-1896 (FAX) 226 parkway, and so that ' s one consideration .

The CASAC panel I wasn ' t on, and probably would have disagreed with, for NOx is pushing roadside monitoring; and that would change the picture entirely if we thought that the proximity to roadway is driving health effects from particles . One could make that argument that we should be looking at roadside levels rather than general community levels , but that gets into another whole range of complication which I ' m not advocating .

MR . POIROT : Yeah . All I was saying, however, was in relating to the eposodicity of the distribution , and I suspect if we went closer to the roads
-- roads are a very chronic kind of a source , not prone to huge episodic releases . They ' re there all the time and so on and so forth . So it ' s just that the distribution would tend, I would think, to be somewhat more normalized and less skewed towards the tails compared to dust storms .

DR . SAMET : Okay . Why don ' t we go on to 10 . Chris , this is you and Mort .

DR . SPEIZER : John, can I add one thing? It seems to me I recall
-- DR . SAMET : Okay . DR . SPEIZER : I don ' t want to put words in1

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Karen Martin ' s mouth, but at some point she had suggested, I thought , that episodic exposure -- episodic events could be excluded in some way from the consideration of the percentile level . Am I correct thinking you talked about that before ?

DR . MARTIN : Yes . We had talked about exceptional events , which don ' t fall in the category of roadside or the kinds of things you were talking about now .

DR . SPEIZER : Is there a way to exclude those episodics without affecting

-- they didn ' t affect the standard?

DR . MARTIN : I ' m not quite sure what you ' re asking . Episodic is not the same as exceptional if
we can predict regular episodes as opposed to truly exceptional events that aren ' t predictable . They ' re just different in kind .

DR . HOPKE : There have been states who have attempted to claim that every time they get a wind storm, it ' s an exceptional event .

DR . SPEIZER : Yeah . Okay . DR . SAMET : Back to 10 , I think . COMMENTS ON CHARGE QUESTION NO . 10 :

DR . FREY : Okay . This is the charge question related to key uncertainties and areas for future1

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research and data collection related to the coarse or PM10 topic . I think what ' s here seems fine just with the comment that it doesn ' t necessarily review the key uncertainties as we discussed also for section 2 . 5 , but it does touch on what seemed like reasonable research needs .

I think in light of the discussion prior to
now it seems worth emphasizing, whether we recommend
a PM10

-2 . 5 standard tomorrow or five years from now presumably, just to reenforce the importance of this information that research does get undertaken , not just research, but also the implementation of the
coarse PM monitoring, at least the limited network that we understand is to be implemented by 20 1 1 , and to point out that that data is critically needed to support a baseline for air quality that might be helpful in setting a future standard and certainly would be helpful presumably with future epidemiological studies . You know, whether those could be completed in a timely enough way to inform the next five

-year iteration , I ' m not sure . So I think emphasizing those needs would be helpful , but I think a lot of the content is actually here . It maybe could just be stated with a little more urgency than perhaps it is now .1

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I think something that I didn ' t find in here is on the topic of continuous monitoring and what we can do to promote that .

And then also , as I commented on section 2 . 5 , I think there perhaps could be a little bit more related to data that would support exposure modeling . Basically, the same comments I had earlier .

I think that ' s all I have right this moment . DR . SAMET : Mort? DR . LIPPMANN : Yes . I thought the
-- again , it was a good summary statement . There was just one boner in it that needs to be addressed . That one is animal toxicological studies of long
-term exposures , i . e . , months to years to PM10

-2 . 5 would be useful . Indeed, they would, but they ' re impossible . You
can ' t get particles larger than 2 microns into the lungs of a rodent , and presumably these would be rodent studies . And the few that would get in would not deposit very efficiently in the conductive airways of the lung because of the different structure of four
-legged animals compared to humans with the side branchs . And any other route of administration would be unnatural and likely to cause complications . I don ' t think you ' re going to have tracheostomies in long
-range exposed animals to1

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-1896 (FAX) 230 bypass the filtering capacity of the nasal passages in these obligatory nasal breathers .

So while I ' m certainly sympathetic, and Kent
was right about needing more toxicology, we could certainly use more toxicology with fine particles and perhaps with the larger ultrafines which would get through the nose ; but it ' s impossible to do it in the animals unless very creative people like Kent can come up with a way to actually deliver the coarse particles on a long
-term basis to animals . So I ' m not saying that rules out all toxicology, but it rules out the kind we ' d most like to see .

DR . SAMET : Kent? DR . PINKERTON : Just to follow up on Mort ' s comments . It ' s true , it is difficult . However , rodents do breathe the lower range of the coarse particles . They actually can breathe up to 4 to 5 micron particles and will deposit within the conducting airways . But if it ' s the particles

-- the
coarse particles that are above that size that we ' re really interested in, then we would miss that .

We have done studies with the coarse particles by installation in equal mass volumes to show that
coarse particles from wildfires in California are completely different than an equivalent mass of1

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-1896 (FAX) 231 particles , ambient particles that don ' t come from wildfire sources .

So there can be some things , but as Mort points out , that ' s not a normal physiological pattern; but it may give some credibility to biological plausibility for these coarse particles with installation studies . But inhalation studies
are really limited to that lower range of the coarse particle fraction .

DR . SAMET : Phil ? DR . HOPKE : Yeah . One of the problems here is going to be getting good chemical or proper characterization of the particles because you ' re now going to have a potential for significant amounts of primary biological materials . And so simply doing organic and elemental carbon isn ' t going to tell you what you need to know, and the problem is that we really don ' t have very good methods .

Mark Hernandez at University of Colorado has spent a lot of time trying to work out methods to get these things to work and he ' s got some ideas that are sort of working; but even there , you ' re just getting carbohydrates and protein . So characterization of
some of what may be important parts of the coarse particle aerosol are still things that need to be1

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worked out .

Now, one could do obviously microscopy and morphology to get at some of this , but that becomes difficult to do on a large
-scale network basis . So there are some issues here that need to be worked out in terms of understanding what it is you ' re collecting in your PM10 or coarse particle sample , and they ' re not trivial to sort out .

DR . SAMET : Okay . Anyone else on Question 10 ? Yeah, Ed . PROF . AVOL : Just one comment with regard to this need, just as we talked about on the fine particle recommendations , I think there needs to be a prioritization of the priorities . And maybe in the context of Vanessa ' s presumed meeting this could logically come about .

DR . SAMET : Okay . We ' ve done the coarse particle chapter . Last chance , comments , 7 , 8 , 9 and 10

-- or 6 , 7 , 8 , 9 and 10 ?

DR . SPEIZER : John, are we going to try to
come to a resolution on whether we ' re going to recommend PM10 versus PM10

-2 . 5?

DR . SAMET : I think, Frank, I think we probably got to a point of where the committee is . I think that there ' s at least Phil , on the one hand,1

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and I think probably more to the others who are leaning but not jumping, if that ' s a fair characterization, I think, of the mood of the room .

DR . SPEIZER : Well , maybe we need to quantify it as to where people are .

DR . SAMET : Yeah . I actually think

-- yeah, we went over this a little bit actually when I sort of asked Phil how his remarks would reflect this . And I think it ' s reasonable that there is in fact a range of views at the moment , but I think

-- I ' m not
sure I need to poll . But let me ask, I ' ll do this briefly .Are there any other jumpers ?

DR . SPEIZER : I think I ' m just coming to jump . I ' m not sure of where I was before .

DR . BRAIN : Why don ' t you state your proposal , Phil ? DR . SAMET : Phil , yeah .

DR . HOPKE : I mean, at this point , you know, because I assumed that John was going to grab me to write a paragraph for the letter , and so my thought
was that we would say something like , although there
was extensive discussion of PM10

-2 . 5 indicator , the Panel felt that at this time the evidence was not sufficiently strong to move to that , but there was1

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the need for the accumulation of the monitoring data
so that further epidemio

-- you know, further studies could be made to ascertain the need to move to this
as the indicator, or something like that .

DR . BRAIN : But it really seems like there ' s quite an elaborate database about health effects . Of
course , you know, there ' s a whole chapter on it .

DR . HOPKE : That ' s why I think it ' s time

-- DR . BRAIN : I guess I would join the jumper

-- DR . HOPKE : It ' s time to say this is where we ought to go .

DR . BRAIN : I would join the jumper camp . DR . HOPKE : That ' s good . DR . SPEIZER : If we move to -- DR . SAMET : I think we have
-- DR . SPEIZER : -- the majority are jumpers , then I think we do have to come up with some numbers .

DR . BRAIN : Yeah, right . DR . SAMET : Well , how many jumpers are there? Frank, you ' re --

DR . SUH : I might be a jumper . DR . SAMET : You might be a jumper . You have to be a jumper or not a jumper . You can ' t might be a jumper . DR . SPEIZER : All right . I ' ve become a1

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-1896 (FAX) 235 jumper . I can ' t see the rest of the group .

DR . SAMET : Frank, I think you said you were a jumper . We hear you mumbling in the distance .

DR . SPEIZER : Yeah . I ' m going to be a jumper . I can ' t see the rest of the group .

DR . HOPKE : Well , it looks like Harvard and Clarkson , and the rest of the folks are staying well up on the cliff .

DR . SAMET : Yeah, Mort? DR . LIPPMANN : Being a practical sort of engineer by origin, I ' m not ready to jump now, but we never will be if the monitoring situation remains as it is ; and so I think we ' re betwixt and between . We need the data to justify switching and until we switch we ' re not going to get the data . So I think a very strong recommendation is needed that simultaneous adjacent collections are really going to be absolutely needed if we ' re going to be able to make a rational move in the next round .

And if in fact you do have dichots ready to go , let ' s start using them because that will give you the basis for having a database that can be analyzed and used .

DR . SAMET : How big will the data
-- how many monitors will be implemented?1

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MR . HANLEY : So there ' s a few things going on . Joann is here , and she can speak to the coarse speciation work that she ' s leading up in St . Louis and Arizona . That ' s a limited pilot at the NCore stations . There ' s approximately 8 0 of those . About 60 are urban locations where coarse mass by approved methods , including dichots , FRM in one approved continuous method will be available .

Then in addition to that , of course , there are a number of locations that have the prized existing
co-located data with, you know, sufficiently high quality instruments that you could
-- you know, folks could use the data now . I think it ' s fair to say there ' s not a coordinated effort amongst health researchers and the cities and states and EPA to make
sure that every health study has the right , you know, methods in place ; but I think what I ' m hearing here , and I don ' t disagree with it , is that kind of push needs to be
-- needs to be made .

DR . BRAIN : Can we recommend a direct measurement of the coarse fraction whenever possible , something like that ?

DR . LIPPMANN : I ' ll point out that some data
are being collected which could prove interesting and available and in publication by the next round, and1

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that ' s the NYCCAS study in New York City . It was 15 5 two-week samplers on utility poles , and that ' s been supplemented in a pilot that NYU added to it with PM10 samplers in addition to the PM2 . 5 samplers and all the filters are being speciated . So it ' s a unique sampling strategy . It gets at heterogeneity associated with roads and other things in a big urban
area . And I think as the publications begin to come out that it provides a model that could be done in other locations that would generate the kinds of data that we ' re talking about , albeit in a limited number of locations and situations . But if EPA can encourage , support , sponsor that kind of work in other locations that differ from New York
-- you know, New York being unique in many ways , it would be
an extremely valuable at least set of pilot information that would help set the stage for the future . You ' re familiar with NYCCAS , I presume?

MR . HANLEY : Yes , I am . DR . SAMET : Sverre? DR . VEDAL : Yes . So I mean, I think arguments in favor of better coarse monitoring network are sound . I ' m not -- I don ' t think I ' m ever going to be in a position to support a national coarse standard1

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until we have the following bit of information that
we have some comfort with, either that the composition of coarse PM doesn ' t matter or that we ' re in a position to recommend a species

-specific coarse standard . A mass-based coarse standard at this point I think is just wrong .

DR . SAMET : Helen? DR . SUH : Well , actually, I think I was going to speak to the same issues Sverre did is why I ' m a partial jumper is really this notion about the windblown dust versus the urban coarse particles . And I think that , not only should the monitoring

-- increased monitoring be advocated strongly, but also there needs to be some push for the monitoring being done in diverse areas that include the areas characterized by high windblown dust coarse particle concentrations and those in the urban areas so there
can be some -- begin to have some understanding of whether or not coarse particles mass is the issue or whether it ' s some particular attribute of the coarse particles themselves , and I think that would be critical .

DR . SAMET : Tom? DR . MOORE : I just wanted to point out that if there ' s a warmer, drier climate on the way, that it1

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-1896 (FAX) 239 might be a good idea to ask for some of that as well , so . DR . SAMET : Okay . So I guess the question

-- I mean , Phil , you ' ve got a sense of the balance here between jumpers and non-jumpers . I think let ' s leave this for the moment , just circle back .

I understand
-- it ' s ten after 4 : 00 . We ' re not going to move on to visibility, the Secondary Standard today . We ' ll do that tomorrow . I think that does two things . It just gives us a chance to
revisit for the moment anything under the fine PM standard to discuss getting our letter written and drafted . To the extent that work can be done here , I think that would increase our -- increase our efficiency and will be helpful , and it ' s not that working this afternoon will keep you from going anywhere . So I think we could use the time .

So just to go back, we spent a lot of time this morning on issues related to fine PM . I think it ' s fair to say -- and I think that this came through particularly as we addressed these charge questions 1 , on the approach taken to developing the document , that , in fact , in terms of process , I think this cycles through the whole PM . This being our first , I guess , through the whole new ISA, REA,1

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-1896 (FAX) 240 Policy Assessment , it seems to have flowed rather well in the end in that the kinds of decisions that
were made in the ISA and that help guide what outcomes should be looked at in the REA and then what outcomes were of concern in the policy analysis , I think created a relatively transparent approach . At least in my mind comparing, if you go back ten years , the criteria document to staff paper , et cetera , it ' s a very, I think, much more evident and defined process . And I think your diagrams were good . Now you just have to go back up a little bit and put in the rest of the story . And so I think this has worked out , and I guess we ' ll have another
-- some other examples flowing through now .

So it ' s good . And in fact , I think you saw that the Panel in general was offering very positive comments about the Policy

-- Policy Assessment . So again, I think you should take that as a reflection of a process that seems to be working and a lot of hard work on the part of the Agency ' s staff . This is actually praise , so take it ; and it ' s deserved . I
mean , obviously, with the schedule that you ' re on for all these documents , it ' s an awful lot in motion at the same time for you .

I think just looking at some of the issues1

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that we covered, there was a lot of discussion about the PM, the 24

-hour PM2 . 5 standard, the annual standard . We talked about a relatively narrow range for both the potential revisions of the 24

-hour standard and the annual standard . Our multi

-colored plot is gone ; but in reality, they were talking about
a relatively small reduction of
-- possibly of the PM2 . 5 24 hours and a range that , at least in absolute terms , are relatively small for the annual , albeit proportionately large , going with a, from 15 to 12 , you know, percentage-wise is a larger reduction .

I think what you heard from the committee is , of course , that as you go lower, uncertainties mount . And that was discussed in a number of ways ranging from model uncertainty to form of the concentration

-response relationship to the declining amount of information and, of course , the widening of confidence intervals in terms of our ability to estimate the dose
-response relationship , but I think also in terms of our general confidence to what the exposure-response relationship might be .

That said, I think what I heard from the group was that the scientific evidence available would support , sort of, any of the combinations within that range that was discussed with declining confidence1

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towards the lower end of the scientific evidence available around the potential for adverse health effects , their existence and public health benefits from a reduction of the standards .

I think the committee was in agreement that the evidence would support a change . The selection of exactly what is the optimum pairing of 24

-hour and annual standards , I think largely then would reflect , sort of, the policy judgment and how to achieve the needed degree of public health protection , i . e . , providing the margin of safety . So I think that ' s what we said there .

You know, I think an important outcome of the discussion around Question 4 , this key uncertainties and future research
-- and this applies , spills over to our Question 10

-- was that we ought to step back and take a broader look and find a way with help from Vanessa and Holly to do that . So I think that ' s where we ended up on the PM2 . 5 standard .

Does anybody want to add anything at this point? (No response . )

DR . SAMET : Okay . And then I think, you know, we just finished the discussion of Charge Questions 5 through 10 , and I don ' t see any point in rehashing1

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the discussion . I think the important key elements of what we talked about was the
-- where the evidence stands on the adequacy of the standard and where the
-- what is the right indicator , I think both key issues . And obviously a lot less evidence and, consequently, a committee that I think offered a more divided judgment reflecting where the scientific evidence stands .

So again, I don ' t know if anybody wants to
revisit any of the issues here , any jumpers want to change their mind, non-jumpers . But otherwise , I think that ' s where we ' ve ended up at 20 after 4 : 00 .

Karen, are there things that you would like to
revisit as we sit here before we break up? It ' s a rare moment when we have time on our hands .

DR . MARTIN : I ' m thinking through what you just reiterated, what you ' ve talked about on coarse .

Of the things you have revisited and sort of done a wrap-up of , the one thing I think I ' m least clear about is the view of the Panel on the issue of the adequacy of the current PM10 standard . There was a lot of discussion about the balance of the evidence , that it hangs in the balance . A couple people spoke to their views that they felt the standards weren ' t adequate . It wasn ' t clear to me if1

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everyone else was in the it

-hangs
-in

-the
-balance camp . DR . SAMET : Okay . Let ' s see , so we had Mort and Frank expressing a view . Others ? Sverre .

DR . VEDAL : I was convinced by Mort ' s argument that we were -- by changing to 85 with that current form that we were going to leave some segment of the population unprotected that was protected by the previous PM10 standard even though there would be some that would be more protected . So I thought on that basis , I thought the argument was reasonably good that the PM10 standard needed revision .

DR . MARTIN : I didn ' t hear the end of your sentence . I ' m sorry .

DR . VEDAL : That needed revision . DR . SAMET : Okay . Any others ? DR . FREY : John? DR . SAMET : Yes . DR . FREY : On the weight of the evidence , Karen, I would also concur I think that needs revision as well .

PROF . AVOL : I think that ' s a comment also from Rogene and myself on Question 6 as well .

DR . SAMET : And I think my comment on this has to do with what I said earlier , which is just to be1

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certain as you discuss this , to carefully separate the strength
-- your response to the strength of the evidence and then the concentration to which people
are exposed in the likelihood of effects .

And I think that ' s where adequacy, you know, this question of adequacy encompasses a number of notions . Again , I think the precedent here is how you respond to suggestive evidence , but then in the end how the Administrator will respond to suggestive evidence , which to me is where
-- and I think Helen alluded to this , is margin of safety a notion related to , as I think it ' s been literally construed, building on some sort of margin on a dose
-response curve of protection or is it a broader precautionary philosophy, which I think was what you were getting at , and that in the absence of certainty about causation there still might be action

-- I don ' t know . I think I would just be clear about the logic .

Yeah, Rich? MR . POIROT : Couldn ' t the statistical inferiority of the expected
-exceedance form be a part of the adequacy argument as well ? I mean , it ' s not the whole thing, but it ' s a good starting point , if for no other reason that ' s inadequate .

DR . SAMET : Okay . Mort ?1

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DR . LIPPMANN : I am questioning Rich . He convinced me it was really equivalent to 7 5 and not 85 , and I ' m surprised he ' s reluctant to say that it shouldn ' t be lower to -- below than 85 .

MR . POIROT : No . I was trying to address the adequacy of the existing standard, 150 expected
-exceedance form, and that part of the argument for why it ' s inadequate has to do with its inferior statistical properties .

DR . LIPPMANN : Right . MR . POIROT : And then we go on from there . DR . LIPPMAN : In effect , you ' re joining those who suggest that it needs to be lower than 85 , or are you? MR . POIROT : Well , that ' s another question .

DR . LIPPMANN : And you don ' t want to answer that . MR . POIROT . Yes , I will join those , but before I do that I ' d like to help us jump off the cliff of the current standard by pointing out Phil ' s argument about the statistical inferiority . That ' s one of several reasons why the current standard should be changed, and then there are others that we come to later .

DR . SAMET : Okay . What I ' m going to suggest1

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then is that , remember, the person who is , sort of , the designated lead discussionist , if you could take
on the role of compiling the comments , if you want input from your colleagues who are here , and we have opportunity to sit

-- you have the opportunity to sit and work together . E-mail your comments to Holly, and she ' ll assemble all this ; and depending on how things go tomorrow, we hopefully will have some chance to put the comments up on the screen and do
some review .

DR . VU : If you have the time to do it , that will be fine . I just don ' t know whether you have the time because tomorrow you still need to focus on visibility . And the folks who lead the visibility discussion on the Secondary Standards will not be able to have a draft
--

DR . SAMET : No , yeah . I meant -- DR . VU : So therefore , you don ' t have any choice but have another public teleconference call .

DR . SAMET : No . My suggestion is if we have time we be prepared to do that . And judging the length of the discussions of the visibility standard every time we ' ve discussed it , we may not get to the opportunity to review the comments . Let ' s see what happens . Alternatively, we can start at 6 : 30 , which1

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would be fine with me .

DR . VU : No , unless you want to lengthen the time tomorrow . I mean, right now, I look at the agenda . You all said 11 : 30 , but there ' s no reason why you can ' t prolong it to 12 : 30 as long as -- I
mean , the issue is whether the lead writers will be able to finish the discussion of all the Primary and the Secondary Standards and get approval on this phone call , I mean, at this face
-to- face meeting . That ' s the question .

DR . SAMET : I actually don ' t see us getting approval , Vanessa , at this meeting .

DR . VU : Oh, okay . Well , in that case -- DR . SAMET : No , no . DR . VU : -- you ' re going to do that
-- DR . SAMET : No . I actually just see us trying to get some of the initial work done .

DR . VU : So you ' re -- I ' m sorry then, John . I misunderstood . So you just want to get -- make sure that the language gets more --

DR . SAMET : Yeah . There was just sort of
-- yeah, follow through
--

DR . VU : Exactly . DR . SAMET : -- and do some discussion here . But no , I actually by no means saw us getting the1

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letter done .

DR . STALLWORTH : So there ' s overnight homework
we ' ve been discussing .

DR . SAMET : Yeah, yeah . So if you can work and get text back in . So then if we have some time to review it

--

DR . VU : Okay . That ' s fine . DR . SAMET : Because I think it ' s taken us , even with our meeting, sometimes a fairly lengthy cycle post-meeting to get our letters together . So I ' m just trying to shorten that down .

DR . STALLWORTH : So that would be due by 9 : 00 p . m .

DR . SAMET : Okay . So thanks , everybody . So I think there ' s a dinner van at 6 : 00 . And tomorrow we reconvene at 8 : 30 , so see you then .

(The meeting was adjourned at 4 : 27 p . m . )

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REPORTER : RWK DATE : 7 /26/2010 T R A N S C R I P T I O N C O R R E C T I O N S U . S . ENVIRONMENTAL PROTECTION AGENCY SCIENCE ADVISORY BOARD STAFF OFFICE CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE ( CASAC) PARTICULATE MATTER REVIEW PANEL PUBLIC MEETING PAGE LINE READS SHOULD READ

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STATE OF NORTH CAROLINA COUNTY OF WAKE

CERTIFICATE OF REPORTER

I , ROBIN W . KING, the reporter by whom the foregoing proceedings were taken , do hereby certify that the proceedings were taken by me in stenotype and thereafter reduced to typewriting under my direction; that I am neither counsel for, related to , nor employed by any of the parties to the proceedings ; and further, that I am not a relative or employee of any participants thereto , nor financially
or otherwise interested in the outcome of the action .

This , the 4th day of August , 2010 .

____________________________ ROBIN W . KING Notary Public in and for County of Wake State of North Carolina

Notary No . 200518700077 My Commission Expires July 4 , 2015
Robin W . King Bryant Court Reporting Services ( 919 ) 387

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