18  quality and then, exposure estimates generated by the

19  tiers that Stephen's gone through.

20	Tier two, if it's judged feasible, and

21  they're, and of sufficient utility for decision making,

22  we involve combining concentration response, if it's

23  based on epi; or exposure response based on controlled

24  human exposure data, with exposure estimates to

25  generate population risk estimates.  It's what we'd

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Page 102

1  like to have, ideally.  We may or may not be able to

2  get there.

3	And next slide, okay.  The tier one, as I've

4  said, the air quality levels from a tier one exposure

5  assessment, or estimated exposure levels from tier two

6  or three,  would be compared to potential health effect

7  benchmark levels for several example urban areas.

8  Those would be the same areas that Stephen's talked for

9  the air quality and exposure tiers.

10	We have identified, very tentatively, in a

11  benchmark of, in the .2 to .3 ppm one-hour averaging

12  time range, based on the controlled human exposure

13  studies, of effects that have been observed in

14  asthmatic, both children and adult asthmatic.  There's

15  uncertainty about those health effect benchmarks that

16  we see, we'd be using alternative benchmark levels to

17  illustrate the impact of alternative choices about the

18  lowest exposure levels of concern.

19	In terms of variability, we address that by

20  doing the analysis in different geographic areas.

21  Population variability in response but it would have to

22  be addressed qualitatively.  We don't have, I think,

23  data to distinguish that very well.  And the projected

24  outcomes would be the number of  occurrences of air

25  quality levels at or above several benchmarks, or

Page 104

1  tier two assessment would be conducted, including the

2  outcome and insights gained from the tier one

3  assessments, both with the exposure and risk

4  assessment, and availability of information and data

5  required to conduct a tier two assessment on the

6  adequacy of concentration response functions, baseline,

7  and getting baseline incidents data for things like

8  hospital admissions and emergency department visits for

9  the example urban areas.

10	Then, the utility or value added to the

11  decision process beyond the insights provided by a tier

12  one assessment, and the feasibility of conducting the

13  assessment within the time constraints that we have.

14	Next slide.  Based on our preliminary

15  analysis of the first draft ISA, the most likely

16  candidate endpoints are listed here.  I think that was,

17  generally, in agreement with what I heard yesterday in

18  the discussion on ISA.  But the strongest evidence from

19  the epi would be for respiratory related morbidity

20  endpoints, including hospital admissions, especially

21  for asthmatics; respiratory related emergency

22  department visits; and respiratory symptoms, such as

23  cough and wheeze, particular in children and

24  asthmatics.

25	Risk estimates, if we do proceed to this

Page 103

1  number of times in a given year that a population or

2  individual experiences various exposure levels of

3  concern.

4	To our next slide.  And a tier two, if

5  conducted, would estimate the number of individuals in

6  selected populations for several example urban areas

7  expected to experience specified health effects more

8  similar to the ozone and PM risk assessments that we've

9  completed in the last couple of years.

10	We judged that it would be more likely that

11  would be based on the epidemiological literature.

12  Preliminary judgment is  that controlled human exposure

13  studies don't provide enough information to identify

14  credible exposure response relationships.  There's

15  enough information to judge benchmarks for the health

16  endpoints, but it's difficult to see how to get

17  exposure response relationships across the range of

18  interest.

19	We're still evaluating.  We're, obviously,

20  listened carefully to what you've said over the last

21  day and a half.  And look forward to seeing how the

22  revised ISA responds to those, in terms of whether

23  there's sufficient epidemiological evidence adequate to

24  conduct a credible quantitative risk assessment.

25	The criteria listed here for determining if a

Page 105

1  stage, we would propose to conduct both sing-, use both

2  single and multi-pollutant models.  And uncertainty

3  would be addressed similar to how we've handled in PM,

4  the statistical or sample size uncertainty, that we

5  would provide confidence intervals around point

6  estimates of risk, and representing a range of results,

7  based on different epidemiological studies.

8	Expected outputs are listed here, in terms of

9  we would look at estimated incidents that can express

10  the results in a number of different ways.  Incidents

11  per hundred thousand and or percent of incidents.  And

12  this would address hypothetical change in incidents

13  associated with moving from just meeting the current

14  standard to just meeting potential alternative

15  standard.

16	The final part of the risk characterization

17  is several things that we've tried to either put the

18  more limited example, like, you know, urban areas

19  analysis, is one to summarize U.S. air quality

20  information, and discuss the various health effects

21  that we were not able to quantify from the ISA.  So,

22  that would certainly be part of the exposure risk

23  report to provide context for those things that we do

24  deal with quantitatively, and would include those air

25  quality statistics for all air as the U.S. based on the

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Page 106

1  NO2 monitoring data.  And that we'd also provide

2  information, national scale information on the size of

3  potentially susceptible or vulnerable populations as

4  part of that.

5	DR. JENKINS: Okay and this slide just

6  has the charge questions to CASAC.  This is actually a

7  condensed version of those charge questions, because we

8  actually had too many to fit on a single slide, but I

9  think this captures them.

10	DR. HENDERSON: Thank you.  Karen, do you

11  have more to present?

12	DR. MARTIN: I don't believe so, unless

13  there are some specific questions.

14	DR. HENDERSON: Okay, now, Lianne, you're

15  on the phone?

16	DR. SHEPPARD: I am.

17	DR. HENDERSON: When are you leaving?

18  I'm just trying to - -

19	DR. SHEPPARD: I have two more hours.

20	DR. HENDERSON: Oh, okay.  I was going-,

21  that's good, Lianne.  I just wanted to allow you to ask

22  questions if you were leaving.

23	DR. BALMES: Rogene?

24	DR. HENDERSON: Yes.

25	DR. BALMES: This is John Balmes.  I'm

Page 108

1  lot of concern about this morning.  But let's start in

2  on the discussion of the air quality section, which is

3  very brief in this report, and has lots of discussants.

4  So, we may have more discussion and, than there is

5  text, here.

6	SPEAKER: Than material.

7	DR. HENDERSON: But, what I'd like to do

8  is run through, you know, there's three, the air

9  quality section, the exposure section, and the risk

10  assessment section.  We're going to have, open the

11  discussion up to anyone who has any questions.  We

12  tried to group people as to their interest, rightly or

13  wrongly, so let's start out with, on the air quality,

14  Ellis, did you have some comments you wanted to make,

15  or you know.

16	DR. COWLING: I must say that the general

17  impression I have is that the approach is being, that

18  is being proposed is reasonable, and that I have

19  confidence that it will be pursued within the limits of

20  time available that were mentioned.  The five months

21  shorter time frame, I'm sure has caused some anxiety

22  within the staff about how to get all the things done

23  that they had hoped that they can accomplish.  But, I'm

24  satisfied that the approach being proposed is

25  reasonable.

Page 107

1  going to have to leave to teach in a few minutes, and I

2  will be returning in time for the health effects

3  discussion, which is currently scheduled for, what is

4  it, 2:15 your time?

5	DR. HENDERSON: We may be getting to that

6  a little earlier, because I plan to have a working

7  lunch.

8	DR. BALMES: Well, I just, I have to

9  teach, so I won't be able to join the call till a

10  little bit after 2:00 your time.

11	DR. HENDERSON: Okay.

12	DR. BALMES: Just so you know.

13	DR. HENDERSON: Okay.

14	DR. BALMES: I don't have a specific

15  question right now, though, just letting you know.

16	DR. HENDERSON: Okay, and if you, let us

17  know when you join in.  Okay, I found it fascinating

18  our discussion just before we started this about, you

19  know, the annual average standard and how that relates

20  to peak exposures.  And this group has, obviously,

21  addressed that, and I, in a statement, if the existing

22  annual standard is obtained, short-term NO2 levels of

23  potential concern would be unlikely in most parts of

24  the country.

25	That, would, addresses some things we had a

Page 109

1	DR. HENDERSON: Thank you, Ellis.  Donna,

2  do you have any comments on this, the proposed methods

3  for air quality evaluation?

4	DR. KENSKI: Well, I guess I have a

5  question.

6	DR. HENDERSON: You need to get close to

7  your mike.

8	DR. KENSKI: Okay, sorry.  In answer to

9  the, I guess, the charge question about whether it was

10  appropriate to use historic data, I thought that was

11  the logical approach.  I, the question I had was in

12  the, how you're modeling expected exceedances, and it

13  gives an exponential model here, and I just wondered if

14  there were any discussion about that choice of model,

15  and whether you considered other models.

16	DR. GRAHAM: That's a good question,

17  thank you.  We've got, that, actually, had been used in

18  the previous review.  So, as I was looking to, I guess,

19  duplicate that effort, but in addition to that, we are

20  also going to look at an alternative model that looks

21  at, like a logistic regression, so it'd be more

22  probability based.

23	DR. KENSKI: Okay, yeah, I think that's

24  appropriate.

25	DR. GRAHAM: Thanks.

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Page 110

1	DR. HENDERSON: Is that all, though, or

2  did you - -

3	DR. KENSKI: Oh, well, another question

4  about your choice of, and I'm not sure if this really

5  fits in, maybe it does.  Your choice of cities, New

6  York wasn't on this list, and that seemed odd to me

7  that, 'cause it was one of the higher, definitely one

8  of the higher concentration cities.  So, if you're

9  looking for peak exposures, it seems like you'd choose

10  those urban locations, and it has lots of monitors.

11	DR. GRAHAM: Right, I think Philadelphia

12  was selected over New York, per se, because of, it was

13  representative of a northeastern region, but the key

14  feature there was the availability of additional data,

15  including very refined roadway counts, and other data

16  that had been developed previously through other

17  research.  So, I thought it would be a slam dunk, per

18  se.

19	DR. KENSKI: Okay.

20	DR. HENDERSON: Is that all?  Tim Larson,

21  are you on the phone?

22	DR. LARSON: Yes, I am.

23	DR. HENDERSON: Okay, did you have

24  comments on the methods for the air quality section?

25	DR. LARSON: Yes, a couple.  It wasn't, I

Page 112

1  I guess, the question is, how do you see that going

2  down?

3	MR. RICHMOND: Okay, this Harvey

4  Richmond.  Let me try to address that.  In, if we can,

5  the risk assessment has said, at first one tier,

6  there's, if we're looking at results of either the air

7  quality in tier one or exposure, either from a tier two

8  or tier three, either APEX or otherwise exposure

9  estimates, we're comparing, we're using all of the air

10  quality information.

11	We're using the monitoring, but also,

12  enhancing that with additional information to try to

13  estimate, either, a surrogate for exposure or getting

14  the distribution of exposures.  That's then going to be

15  compared with a health benchmark levels that are based

16  on the controlled human exposure studies.

17	So, we're trying to match exposure with an

18  exposure response or an exposure, you know, an effect

19  observed in a clinical setting.  That's one use of it.

20  And separately, if the epidemiology is deemed that it's

21  sufficiently one that is likely causal, or you know,

22  whatever we decide to go down on that continuum of

23  causality, that we're going to quantify, if we quantify

24  an effect from the epidemiological literature, those

25  studies, I agree with you, are based on the ambient

Page 111

1  guess, I have to calibrate my thinking here.  The

2  short-term standard, the health effects for that are

3  based on the analysis of existing monitoring sites for

4  short-term NO2 levels, I assume.

5	Is that the, I mean, is, it seems to me that

6  the relationship between the short-term values and the

7  long-term values, and how you do that, depends on what

8  sort of the health basis you're deriving, using to

9  derive that short-term value.  If it's the epi, then

10  that's one thing, and then, would you just, sort of,

11  use the statistics from existing sites.

12	If it's independent toxicology clinical human

13  exposures, et cetera, then it seems like, potentially,

14  there are different relationships between the long-term

15  and short-term values for parts of urban areas that may

16  be more relevant than ones at the monitoring sites.

17  So, I'm not clear, it's not clear to me which is the

18  basis for your health risk assessments.

19	To the extent that it's the epi, then I

20  suspect that the existing monitoring statistics are

21  relevant.  To the extent it's other, then I would

22  suggest that the relationship, I mean, in the extreme

23  case, for instance, the one-hour peak exposure is while

24  you're commuting, which has nothing to do with any of

25  the statistics or distributions at the monitoring.  So,

Page 113

1  monitoring fixed site monitors, usually the average

2  across several monitors.

3	And if we were to do a risk assessment, based

4  on epi, it would not be based on the exposure analysis.

5  It would be based on the ambient fixed site monitors.

6  I hope that clarifies it.

7	DR. LARSON: Yeah, that helps, thank you.

8  Well, at least to the extent that it's based on the

9  human clinical studies, I would suggest caution here

10  using your near roadway or traffic related impact as

11  models, because I think you get very different

12  relationships spatially and temporally in a flat road,

13  than you would in a built up urban area.  So, I mean,

14  the residential areas of Philadelphia or parts of

15  Chicago or Houston maybe that's, your approach is fine.

16	But we're doing studies in Chicago, and I

17  know for a fact that, is part of our cohort lives in

18  downtown Chicago, and we can't and don't have any

19  success using those kinds of approaches in that area.

20  So, if there was some way to qualitatively screen those

21  parts of the urban areas that are subject, is more

22  complicated confinement effects, so that you would

23  limit your exposure assessment in some way, based on

24  that.

25	I would think that's more defensible.  You

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Page 114

1  get a qualitatively different in a distribution and

2  it's not only, then becomes determined by the geometry

3  of your urban area, but also you end up with this

4  question about the vertical distributions within those

5  confined areas.

6	And then it, then you  really up, you really,

7  you know, it's an open question as to where the,

8  whether you've got buildings with open windows, or

9  whether you've got inlets of a building in a

10  residential apartment on the roof or on the ground or

11  whatever, and it gets real complicated in a hurry.  And

12  the, I guess, the basic point is that a simple, sort

13  of, Gaussian dispersion model do not have much skill in

14  those parts of the urban area.

15	So, I mean, maybe it's a qualitative way to

16  assess, you know, there are methods for doing that.

17  You know, you can look at building footprints, and

18  overlay building heights.  We've done that in New York,

19  and we're doing it in Chicago.  And you can, sort of,

20  identify the areas that are, you can just look at

21  Google, actually, and probably do the same thing, but

22  more quantitatively, you could do it that way.  But I

23  would say your proposed approach air mod, et cetera, is

24  fine as long as it's, sort of, single family

25  residential, but otherwise, it's questionable.

Page 116

1  the exposure field as to what they think about that.

2	DR. HENDERSON: And that brings me to a

3  point that I had meant to bring up earlier.  For all of

4  you who have not yet submitted your individual comments

5  on this methods document, that's just essential in this

6  case, because the letter will not, it will be more pro

7  forma when it's not going to list the consensus.  So,

8  the advice that you want to give to the Agency in this

9  consultation will come in the form of your individual

10  written comments, so that increases their importance.

11  Tim, is that, are you, have you completed your comments

12  on the air quality section?

13	DR. LARSON: Well, I, yeah, I think

14  that's, wait a minute.  It certainly, EPA, I think, is

15  sponsoring some of the work I mentioned, so, you know,

16  we certainly can do our best to work with the, provide

17  whatever information we have.  We have quite a bit of,

18  Lianne is involved with this, too.  We have quite a bit

19  of NO2 passive monitoring data, saturation data in

20  several cities that we're talking about.

21	DR. HENDERSON: I'm sure they'd

22  appreciate having all the information you can give

23  them.  Ted, would you - -

24	MR. RICHMOND: Can I just ask one

25  clarifying question?

Page 115

1	DR. HENDERSON: Do you have a response to

2  that, I mean, to that, Harvey?

3	MR. RICHMOND: One thing is I'll note

4  historically, it's one of the reasons why there hasn't

5  been an NO2 exposure analysis in the reviews that I was

6  involved in '85 and '93, is doing this is much more

7  challenging than doing an ozone exposure assessment.

8  And we acknowledge that.

9	I think we're, you know, we're saying, we're

10  trying to push the envelope as far as we can, and we're

11  still in the learning phases as to how far that is, and

12  we'd certainly be interested in the kind of information

13  that, Tim, that you've cited that, you know, if we, for

14  some of the example cities, if you have relevant

15  information, or ideas on how best to do it, or if we,

16  simply, you think if the advice of this committee is

17  we, simply, aren't able to credibly do certain parts of

18  the analysis.

19	Obviously, from a public health standpoint,

20  you'd be interested in those levels in those places

21  where you're saying it's most difficult to conduct the

22  assessment.

23	So, that's the challenge we face, and this is

24  a general road map.  We'll see as we get into it, but

25  we look to the advice of this committee and experts in

Page 117

1	DR. HENDERSON: Sure.

2	MR. RICHMOND: Tim, that saturation data,

3  is it for short-term averaging?

4	DR. LARSON: It's, no, it's two-week

5  average - -

6	MR. RICHMOND: Two-week average.

7	DR. LARSON: Yeah, so that's a problem,

8  but, yeah, it's a problem.  But it - -

9	MR. RICHMOND: Okay, I just wanted to

10  clarify it.

11	DR. LARSON: It can identi-, I mean,

12  we've done models, though.  We, in New York,

13  specifically, we've done, we've implemented the OSPM

14  model for New York City, which is kind of an

15  interesting exercise.  And, to do that, you have to do,

16  or you have to have information on building footprints.

17  It's a massive undertaking, but so, we have, we have

18  hourly predictions compared to our measurements.  And

19  they compare pretty well.

20	I mean, it is reasonably, if you expect to

21  model that.  So, they do have skill, and they, and we

22  do have predictions on an hourly basis, both as an

23  urban background model, and superimposed on that is a,

24  is an OSPM model, and using Mobile Six and the traffic

25  - - model for New York City.

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Page 118

1	DR. HENDERSON: Okay, let's move on to

2  Ted.

3	DR. RUSSELL: Okay, very much like the

4  prior individuals, I was, generally, pleased with the

5  scope document.  One of the things, I think, that comes

6  out of just recognizing that you're going to be doing a

7  number of these, if you look at it more than one a

8  year, to get it down to a well-oiled, sort of,

9  approach, is one of my first recommendations.

10	And I realize you all are, may not have tons

11  of resources or whatever, but just something that could

12  be done such that these things become very automatic.

13  You know, I look at where we've come in other areas of

14  the modeling world, and I think that this could be done

15  when you're looking at exposure and risk analysis as

16  well, just to make it so it's not as, such a huge

17  effort every time.

18	A few things, one of them was, in regards to

19  what you, when you were presenting this morning, you

20  said something about locations considered, and you have

21  the five cities, and then, an aggregation of others.

22  And then you said, possibly, or maybe you said possibly

23  before you said that.  And I, it brings back what we

24  discussed in the lead panel was that, we're, I think,

25  as a whole, more interested in the U.S. than in

Page 120

1  read this, it wasn't just peak exposures.  It was all

2  exposures.  So, I'm just hoping that you're looking at

3  doing the exposure analysis at a national level, not

4  just for five cities, both peak as well as long term.

5	DR. GRAHAM: The air quality data is

6  going to be evaluated nationally.  When we look at the

7  focused exposure analyses, that's going to be on

8  individual cities that had been identified.

9	DR. RUSSELL: I think we would have some

10  interest in, maybe I'm not, maybe I'm singular here, of

11  really the interest at a national level somehow

12  extrapolating or doing something to get, to give us an

13  idea of what's happening nationally, not just at those

14  cities.  Because it came up in the lead.  It came up in

15  the ozone, as well, that that would be some important

16  information.

17	And, let's see, one, just a minor comment, in

18  your model, in terms of how to go away from roads use-

19  -

20	DR. MARTIN: Just, if I may?

21	DR. RUSSELL: Yes.

22	DR. MARTIN: Just to come back to the

23  point you just made.  I can't not make the observation

24  that, as we move to exposure modeling, what we and you

25  both are looking for is to develop enhancements to

Page 119

1  individual cities.

2	I'm just wondering how you can, how you would

3  plan not to do an aggregation of others, because I

4  think that would be somewhat more instructive to us, to

5  show us, on a national basis, the exposures of concern.

6  So, do you want to respond to that, how you're going to

7  make that decision not to do an aggregation of others,

8  or?

9	DR. GRAHAM: Delete possible.

10	DR. RUSSELL: Okay.

11	DR. GRAHAM: No, the intent was, in the

12  original analysis, they had done Los Angeles as a

13  separate area, and everything else was just lumped

14  together.  And here I was proposing, okay, we can do

15  multiple locations, and if it's of value, we can look

16  at these other locations as well.  And the criteria, in

17  a sense, for selecting the individual areas is based on

18  the fact that, we do have some information on the fact

19  that there are more peak occurrences.

20	In these other locations, there may not be.

21  So, in a sense, the model for predicting peak exposures

22  over a particular level, it just may fall apart,

23  because there are no peak exposures.  So, that's why I

24  say possible.

25	DR. RUSSELL: Okay, though, the way I

Page 121

1  those models to be, to address the location-specific

2  issues that are so central to understanding exposures

3  to NO2.

4	Once you zoom out and now say, oh, let's do

5  that on a national scale, you lose all your local

6  specificity, which is why we would approach a national

7  look on the basis of air quality, recognizing it's a

8  pretty gross approximation, and looking on the local

9  level, to try to tease out the nuances of exposures

10  around roadways and building canyons and those sorts of

11  things that we couldn't possibly do on a national

12  scale.

13	So, I mean, we're not trying to be resistant

14  to say, yes, it would be nice to know exposures on a

15  national scale, but I think the best we can reasonably

16  do is to do the more generalized air quality, look on

17  the national scale and to tease out the details

18  locally.

19	DR. RUSSELL: Dale has a comment, I

20  think, in response.

21	DR. HATTIS: Yeah, but, yes, essentially,

22  you've got three legs of a parallelogram approach here,

23  at least, in your plan.  You've got the local

24  assessment of air quality.  You've got the local

25  assessment of exposure.  You've got the national

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Page 122

1  assessment of air quality.

2	I think it's not too much to hope that you

3  apply the lessons from the comparison of the local

4  assessment of air quality and the local assessment of

5  exposure to make, at least, a preliminary national

6  projection of the exposures, if the regularities you've

7  observed in your fully analyzed cases apply to some

8  portion of the national air quality data.

9	I mean, you, probably, wouldn't apply the

10  Philadelphia comparison directly to South Dakota, but

11  you, probably, want to apply it to some portion of

12  South Dakota, maybe, in a fraction of Fargo or

13  whatever, and, to some extent, get.

14	But anyway, that's the basic idea, is that

15  it's, it might not be a tremendous expense and of

16  effort to do that distributional projection for an

17  appropriate fraction of the country, or the country as

18  a whole, you know, even though you don't want to do,

19  in detail, the country as a whole.  You can get an

20  approximation from that, from the comparison.

21	DR. MARTIN: And then, of course, you're

22  left with making the judgment, does the approximation

23  so assume away all the details that are important that

24  you're left with, clearly we could create numbers, but

25  would they be meaningful.  And if they're not going to

Page 124

1  as opposed to standing by the roadside.  So, I guess

2  that I'm thinking that a lot of your, most of your key

3  data that's going to explain health effects are going

4  to come from understanding local variability.

5	And I, and it's where I'm going with this is,

6  is the, you need to associate locally, but you'd

7  probably have to have wide, a careful thought and

8  discussion about the variances even locally, 'cause

9  you're only very, barely touching that, that part of

10  the parameter.

11	Sounds to me like the, if you're doing a near

12  roadway, for example, comparison, you might have

13  various people that are experiencing that for which,

14  that have levels that are many, many times others that

15  are in the same environment because of the way they,

16  the way they were exposed to it.  And so, I'm curious

17  how you'd handle that variability as you let that

18  average out.

19	And that's just, actually, taking exactly

20  your comment and taking it the other direction, even

21  more extreme at the local level that we, actually, need

22  to understand the health effects.

23	DR. GRAHAM: Well, that is part of the

24  plan.

25	DR. CRAPO: Yeah, I like that part, that

Page 123

1  be meaningful, then we would argue, they're not worth

2  creating in the first place.

3	So, that's what we have to deal with, and we

4  can clearly look at it, but that's always the tension,

5  as you point to with lead as well.  And, I didn't want

6  to just slip by this and so.

7	DR. CRAPO: I wanted amplify what you're

8  saying, and maybe, even take it further the other

9  direction, which is that, your data on local data is

10  really still coming from your primary monitoring

11  stations, I assume.  That's correct?  I mean, your,

12  like your, near roadway monitoring stations, and things

13  like that, gives you local data that you'll use for

14  looking at some of the variation at the more local

15  level.

16	But, in fact, what we're learning, as we, or

17  the mornings is, or what we're learning is that there,

18  the local level has even tremendous variability within

19  that.  There's each gra-, I mean, gradients across the

20  roadway are falling away as a, you know, being 10  feet

21  versus 100 feet versus 1,000 feet for roadway has a

22  huge impact on the levels.  And even being in a car

23  dramatically changes the level.

24	I was told during the break that the school

25  buses are 4.6 times higher than ambient inside the bus,

Page 125

1  you had one-hour average, I just really compliment you

2  on the fact that your, you did have the one-hour

3  averaging goals in there.

4	DR. GRAHAM: Well, and to take into

5  account, specifically, roadway, on roadway and within,

6  given buffer distances of the roadway.

7	DR. CRAPO: And what about inside cars?

8	DR. GRAHAM: Sure, on road equals in

9  vehicle.

10	DR. CRAPO: 'Cause that could've, that

11  could, actually, do you have, are you going to have

12  personal monitoring measurements to give you that data?

13	DR. GRAHAM: No, based on modeling.

14	DR. CRAPO: You're just going to model

15  it, okay.  That would be key to this whole thing.

16	DR. HENDERSON: Okay, Ted, did you have

17  more to - -

18	DR. RUSSELL: I think that was,

19  primarily, it, and I'm not sure where we ended up on

20  it.

21	DR. HENDERSON: Well, I heard that we

22  need the local data to be able to relate it to health

23  effects.  I mean, that's, to me, that's, but - -

24	DR. RUSSELL: Right, I think we want the

25  local data, and, just, when we sit here and talk about

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Page 126

1  things later, I think we're going to want to know what

2  are the national implications.  And maybe I'm one of

3  those who says, if you give me an approximate number

4  and say it's really approximate, that's a fine thing.

5  You know, I don't, that doesn't bother me, because I

6  know what I'm basing my discussions on.

7	That is, it's a number and there's

8  significant uncertainty, but it, at least, it's

9  something that gives me an idea of what's happening

10  nationally.  So that was the, that's my major concern

11  there.  And, let's see.  Also, one of the other issues

12  that I, or thoughts I had on this was, how do you plan

13  to provide ambient versus total exposure risks, total

14  exposures and related risks in your assessment, 'cause

15  I think having that comparison would be insightful.

16	MR. RICHMOND: Well, in the past, and

17  we've addressed this in the CO exposure model, where we

18  included passive smoking in gas stoves, we're able to,

19  since it's driven by a model, the exposure part, at

20  that tier of the assessment, to both report total, as

21  well as, just with the ambient.

22	In other words, basically, turn the indoor

23  sources off in the model, and how much is the ambient,

24  both including ambient outdoors and the ambient that

25  penetrated indoors, but in the absence of those indoor

Page 128

1	DR. GRAHAM: In a sense, it's no longer

2  supported, so it may have been used traditionally, and

3  it may look like a reasonable approach now.  I guess,

4  I'm trying to think of the future.  And AERMOD is

5  actually a little bit more advanced.  It's based on

6  boundary layer theory versus stability classes, and has

7  additional capabilities addressing turbulence and

8  meandering.

9	And, I know that the AERMOD doesn't have a

10  line source option right now, but it is something that

11  is being considered in the near future, not in time for

12  this particular review, but it will have that

13  capability.  Right now, what we are proposing is to do

14  link-based emissions, so, and I think it is being

15  applied right now in New Haven, Connecticut, and there

16  has been a paper published recently using CALPUFF,

17  which is a similar type of dispersion model, to do this

18  near roadway estimation.

19	So, it's, I think, not an unreasonable

20  approach, and there will be, I guess, portions of it

21  that, of CALINE that may be investigated.  I think you

22  had also mentioned in your comments earlier about the

23  conversion from NOx to, or shall I say NO to NO2.  So,

24  that may be an important feature there.

25	But, again, it was to look for, look towards

Page 127

1  sources.  So, we do try to provide that perspective of

2  how much is due to the ambient problem, as opposed to

3  indoor concentrations as well.

4	DR. RUSSELL: And that will be included

5  in this?

6	MR. RICHMOND: Yes.

7	DR. HENDERSON: Okay, Christian, do you

8  have?

9	DR. SEIGNEUR: Yes, I only have one point

10  I want to address.  It's, when it does a tier two

11  exposure assessment and the use of the model used to

12  calculate the air quality concentrations, in your

13  document, you mentioned you plan to use AERMOD.

You,

14  also, mentioned the model CALINE4.

15	My understanding is that AERMOD was the route

16  for stacks, dispersion of protons from stacks.  CALINE4

17  is most specific to roadways.  So, could you clarify

18  why you're planning to use AERMOD other than

CALINE4?

19	DR. GRAHAM: Absolutely.  While it had

20  been recommended to me that I use CALINE for, I'm

21  sorry, AERMOD for few reasons, CALINE, from what I

22  understand is, the developer of that model had recently

23  retired, and Air B has no initiative to continue on

24  developing that model.  So, we can consider that an

Page 129

1  the future, and, in addition, the fact that we are,

2  also, going to look at additional sources, some of

3  which are stationary type sources.  So, why not use one

4  model to head all the emission sources.

5	DR. SEIGNEUR: Okay, yeah, that will be

6  fine.  My recommendations, though, would be that if

7  you're going to use AERMOD for roadways, that it would

8  be evaluated prior to, with data graded near roadways

9  prior to its application.  'Cause EPA, typically,

10  requires people to evaluate the models before they are

11  applied.  So, in this case, since AERMOD has not been

12  formerly evaluated for roadway application, that, you

13  know, EPA would do that.

14	DR. GRAHAM: Right, yeah, and I did

15  forget to mention that, that AERMOD is the recommended

16  model, at least for dispersion.

17	DR. HENDERSON: Now, does anyone else

18  have something they want to comment on the air quality

19  section, 'cause after this, we'll move on to the

20  exposure.  Yeah, Ron.

21	DR. WYZGA: I have some questions.  Let

22  me say that, I'm very impressed by the approach, and, I

23  think, a really good understanding of the exposures

24  here, and I think you're, really, getting it.

25	I think you, it's going to be a challenging

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Page 130

1  job, but my question was, when you talk about just

2  meeting the current standard scenario, I just want to

3  see if I understand it.

4	The current standard is 0.053 ppm, and let's

5  say, that you come up with a health benchmark, a new

6  one, of .05.  And that, if, let's say, one of your

7  cities, your concentration is .04.  Does this mean

8  that, in your risk assessment, you're going to assume

9  that the people are exposed to .053, as opposed to .04?

10	DR. GRAHAM: That's a tough one.

11	MR. RICHMOND: Our dilemma is, for our

12  purpose, not an impact assessment.  We're looking at,

13  in the country, we have levels, typically, down at .03

14  and below.  So, we're well below the current standard,

15  annual averages for the current standard.

16	How do we assess what the risk is for meeting

17  the current standard.  It's not the risk from recent

18  air quality, which is lower.  Is there a scenario, you

19  know, that we look at as a hypothetical scenario, that

20  matches exactly the current standard at the monitoring

21  network, in the design monitor just meets the 53, you

22  know, ppb.

23	There are two, you know, sort of, basic

24  choices, and I'd be interested in comments from the

25  committee.  The one we put forward but were, like to

Page 132

1  standard.

2	DR. WYZGA: My only concern is that, I

3  think, the risk estimate that you come up with is going

4  to be misread as to, this is the current risk, and - -

5	MR. RICHMOND: Right, and it's not, and I

6  appreciate that.

7	DR. WYZGA: - - and I think that's

8  something that, really, if it's done this way, you need

9  a very strong statement telling people what it is not.

10	MR. RICHMOND: Right, and we agree.  It's

11  a very hypothetical, and I agree, sort of, with your

12  comments that if we go down this path, whichever way we

13  do to simulate the current standard, we need to make it

14  clear how unlikely that is, given current NOx

15  stationary controls, given NOx vehicle controls, you

16  know, that's a very unlikely scenario.  But, that is,

17  sort of, the baseline if you're looking at, what are

18  the risks that would be, if you were just meeting the

19  current standard.

20	DR. HENDERSON: Important point.  Yes,

21  Kent.

22	DR. PINKERTON: Although this may be

23  somewhat of a trivial question, I noticed in figure

24  two, when it shows the NOx emissions that, where

25  they're coming from, and I understand that the focus

Page 131

1  hear views on, is to use recent, meaning recent the

2  last time places did not attain or were just in

3  attainment of standard.  In L.A., it wasn't that long

4  ago, had levels that were approximately the current

5  standard.

6	That's one approach to use historical air

7  quality in the '90's, generally, when some of these

8  locations were just meeting the current standard.  The

9  other choice is to use some kind of roll up approach.

10  And then, the question is, do you do it proportionately

11  and roll all the monitors up from current levels to

12  just meeting standard.  And, I believe, UARG had some

13  comments about that very issue, so I'd encourage you to

14  look at that.

15	They were actually arguing not to use the

16  historical approach, but that it would be better

17  rolling up the monitors that were nearest the road, and

18  then, rolling up the other monitors not as much based

19  on relationships between near roadway monitors and the

20  other monitors.  So, that's an alternative approach.

21  And I don't think we're fixed, yet, on exactly which

22  approach, but we put forward as, to get reaction, at

23  least.  You know, how else are you going to do it.

24  Otherwise, we don't have any results for risk or

25  exposure or air quality that approximate the current

Page 133

1  has been, primarily, on urban areas and near roadways,

2  but I noticed that close to 20 percent of NOx emissions

3  come from off highways.  And so, I'm just curious if

4  rural areas or areas of high agricultural activity, do

5  they contribute to NOx emissions, and are we missing

6  something by only focusing on urban areas or near

7  highways?

8	MR. RICHMOND: I don't know if we're

9  prepared to say much.  The one thing I will note, I

10  think we were going to look at an air quality tier one,

11  was major power plants sometimes are sited.  I know in,

12  I think it was Charlotte Mecklenburg, I know the case

13  where it was sited, just outside the ozone non-

14  attainment area, coal-fired power plant.  And we have

15  the ability of modeling to see what kind of NOx levels,

16  NO2 levels would we expect around some of those point

17  sources.

18	They may or may not be peaks of concern.

19  Maybe they're still,  with controls that we have on,

20  don't reach those levels.  I don't know if on, have any

21  information on that, but that's the kind of thing we

22  will look at in the screen analysis, do we have any

23  potential problems outside due to some of these may be

24  that we know which sources from the emission inventory

25  are major contributors to that.

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Page 134

1	DR. KENSKI: Kent, maybe I could clarify

2  a little bit.  That off-highway category includes

3  sources like construction equipment and marine, you

4  know, boats, lawnmowers, all those things.  And so, you

5  could make the assumption that they, generally, follow,

6  sort of, a population distribution.  I mean, the

7  distribution of emissions in that category would be

8  highly correlated with population.  So, to that extent,

9  you could assume that it was more urban and less rural.

10  Although, certainly, you know, farm equipment is a part

11  of that category.

12	DR. PINKERTON: Okay, thanks.

13	DR. HENDERSON: Okay, I think we've,

14  actually, already moved into the second section, the,

15  our exposure section, and - -

16	DR. SHEPPARD: Rogene, before we

17  continue, I wanted to comment a little bit more on the

18  air quality modeling.

19	DR. HENDERSON: Go right ahead.

20	DR. SHEPPARD: You know, well, before I

21  start, if everybody who's on the phone could mute their

22  line.  That would be really helpful.  You can press

23  star six if you don't have a mute button.  So, the

24  complexity of the modeling, I think, is ex-, of the air

25  quality model is extremely challenging.  And Tim

Page 136

1  important again, depending upon the purpose of what,

2  what the analysis is trying to do.

3	The other comment I have, beyond that, is, if

4  it could simplify the work, or at least make it clearer

5  to those of us who are reviewing it, how much each tier

6  is completely conditional on the previous tier, and to,

7  perhaps, take out anything that's overlapping.  For

8  instance, between tier one and two, that looks like

9  there's some different overlapping efforts that are

10  going to be done, and can those, can some of that be

11  removed and done in only one tier.

12	DR. HENDERSON: Do you have a response,

13  anybody want to respond to a question about the

14  overlapping of the tiers.  Again, we've gotten into the

15  exposure area, but that's fine.  That's where we're

16  supposed to go.  No comments.

17	DR. GRAHAM: We'll take a look at that.

18	DR. HENDERSON: You'll take a look at,

19  okay.  That's all we need.  Thank you, Lianne.  Did you

20  have more to, comments to make?

21	DR. SHEPPARD: I do, but maybe I'll wait

22  until other people talk about exposure, and then chime

23  in later.

24	DR. HENDERSON: Okay, well, I know you

25  still have, you'll still be there another hour or so?

Page 135

1  touched on that a bit with the street canyon issue.

2  And there's so many assumptions that are in here.  And

3  it, it's, also, I was, it really hit home, the comment

4  about the resource limitations.  And this is a,

5  potentially, a huge effort to get it right.

6	I think simplifications are possible,

7  depending on the purpose of the analysis, and I'm, it

8  strikes me as this air quality modeling is being done

9  for many different purposes, which means that

10  simplifications, if you had only one purpose, may not

11  be as easy.

12	You know, if you just want exceedances, you

13  might be able to simplify in different ways, than if

14  you wanted predictions.  Because you're going to be

15  using the predictions, for instance, in the APEX model.

16  If you're focusing just on long-term exposure, there

17  are simplifications; but if you want the short-term,

18  one-hour, that means a lot more complex model.

19	It's not so clear that temporal and spatial

20  variation in NOx are separable in the sense that, when

21  you're really near roads, the temporal patterns are,

22  probably, really different than locations far away from

23  roads.

24	So, thinking about which monitors are

25  representative for the analysis becomes really

Page 137

1	DR. SHEPPARD: Yeah, right.

2	DR. HENDERSON: Doug, you have comments

3  on the exposure method, the tiered approach, et cetera.

4	DR. CRAWFORD-BROWN: There's no lunch

5  first, then?

6	DR. HENDERSON: No.

7		DR. CRAWFORD-BROWN: Just wanted to know

8  where we stood with lunch, that's all.

9	DR. HENDERSON: Oh, well, lunch is coming

10  in thirty minutes.  Oh, lunch is ready.  I suggest we

11  have a working lunch.  I thought, maybe, according to

12  our schedule, we would go to, we would have lunch at

13  12:30, that we might make a little more progress, but

14  if hunger pangs are striking, I don't mind.

15	DR. CRAWFORD-BROWN: I'm not taking the

16  rap for this here.  I just wanted - -

17	DR. GORDON: Let me take the rap.

18	DR. HENDERSON: When you said to know,

19  it's good to know what the plan is.  Let's work a

20  little longer, I feel like.

21	DR. CRAWFORD-BROWN: Okay, I don't care.

22	DR. HENDERSON: I'm not hungry yet.

23	DR. CRAWFORD-BROWN: Is this on?  Is this

24  one on?  I'm not, is there a reason you're holding the?

25	DR. HENDERSON: It's just because I can't

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Page 138

1  reach and yeah, it's on.

2	DR. CRAWFORD-BROWN: Okay, well, first, I

3  like the exposure section, as I mentioned in my

4  comments.  It, really, is very much in the line of a

5  wide range of other kinds of assessments that the EPA

6  has done over the years.  And it, really, is, I would

7  say, you know, partially in answer to Ted's issue, the

8  exposure and the risk side is starting to get pretty

9  automated these days.

10	The models are not quite plug and chug,

11  because situations change quite dramatically.  I was

12  very comforted when you said that you would use the

13  epidemiological results with air quality information

14  and the clinical studies for the, I hope I'm getting

15  this right, for the actual inter-subject variability

16  kinds of calculation, 'cause I always worry about using

17  the epidemiological results to get your slope factor,

18  or whatever, and then, also, doing inter-subject

19  variability.

20	Because the epi results, in fact, already

21  have that convolved inside of it.  And so, I hope I'm

22  understanding that correctly.

23	MR. RICHMOND: That is correct.  And if

24  you'll look at the ozone staff paper, and risk

25  assessment, you'll see that's exactly what we say - -

Page 140

1  you could do is, you could imagine that the different

2  tiers are different levels of uncertainty, or you can

3  imagine that the different tiers address different

4  kinds of questions of one, the lower tiers having to do

5  with questions about the upper percentiles of exposure.

6  And the other ones covering the whole exposure realm.

7  And then, the only other comment I would make now, the

8  rest are all in my written comments, is, I do think on

9  the uncertainty side, you've got a significant amount

10  of work to do there.

11	You always will have that.  You've got this

12  challenge of combining the, what are going to be

13  necessarily qualitative aspects of uncertainty with

14  more quantitative aspects of uncertainty, aspects of

15  uncertainty that have to do with scenario

16  specification, and so forth, and other aspects having

17  to do with uncertainty in parameter values.

18	And I'll be interested to see how you fold

19  those things together into some, sort of, overall

20  judgment of uncertainty here.  I agree with the

21  direction you were, sort of, heading, which is to make

22  it, you know, to leave this sort of expert judgment as,

23  and sort of semi-quantitative uncertainty bounds in the

24  assessment.

25	I think that will be important, rather than

Page 139

1	DR. CRAWFORD-BROWN: Yeah, exactly the

2  same thing, yeah.

3	MR. RICHMOND: - - where we had clinical

4  data and epi data.  We made that point.

5		DR. CRAWFORD-BROWN: Yeah, good, okay.  I

6  wasn't quite clear on one thing, which has to do with,

7  as you move from tier to tier, are you moving from tier

8  to tier because of things that you see in the previous

9  tiers assessment, like a screening method, for example,

10  that say, oh, if I look at the upper 95 percentile,

11  boy, that's really large.

12	So, I, that risk is large, so I better do a

13  more detailed one.  Or I look at it and it's very

14  small, so I don't need to do the more detailed one.  Or

15  are you moving from tier to tier based on whether the

16  data are available to move to the next tier.  I'm

17  assuming, maybe, a little bit of a combination of

18  those.

19	DR. GRAHAM: Right, I'd say both.  And

20  the hope would be that the prior tier is, in a sense,

21  more conservative or, well, I don't want to say,

22  hopefully, it's more uncertain, but we want to reduce

23  the uncertainty in progression from going from, say, a

24  tier one to a tier two or tier three.

25	DR. CRAWFORD-BROWN: Okay, 'cause is

Page 141

1  thinking that everything can be reduced entirely to the

2  kind of more quantitative probability density functions

3  on uncertainty.  But, in the end, you'll just have to

4  figure out how you're going to present that as a story,

5  the overall uncertainty.  But I thought the

6  methodologies were quite good.  That's all.

7	DR. HENDERSON: Thank you.  Terry Gordon,

8  do you have some assessment, or advice to give on the

9  exposure section?

10	DR. GORDON: Well, I'd say quantitative

11  risk assessment is a weak point of mine, so I don't

12  have really much to say, except exposure.

13	DR. HENDERSON: Well, this is exposure,

14  yes.

15	DR. GORDON: Well, see my confusion of

16  the terms shows - -

17	DR. HENDERSON: Well, we're talking about

18  the exposure section, not the risk assessment.  I mean,

19  the tiered exposure approach.

20	DR. GORDON: So, not the-, we're on the

21  health effects or not?

22	DR. HENDERSON: No.

23	DR. GORDON: Oh, no.

24	DR. HENDERSON: So, are you still, are

25  you just still, okay, that's fine.

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Page 142

1	DR. GORDON: Well, I was going to read

2  Ellis' comment.

3	DR. GORDON: I have no experience in

4  which to basically form judgment.

5	DR. CRAWFORD-BROWN: That didn't stop me

6  from talking.

7	DR. GORDON: Well.

8	DR. HENDERSON: I got the message.  Okay,

9  Jim Ultman, are you on the phone?  Have to wait for

10  people to un-mute.  Lianne, you said you wanted to save

11  your comments.  Do you have any further comments, and

12  then I'll open it up to the whole group.

13	DR. SHEPPARD: Well, you know, I'm

14  looking over what I wrote.  And I prepared an extensive

15  set of comments, but a lot of them are fairly detailed,

16  and probably aren't worth discussing now.  But the, my

17  comment about the purpose of the tiers, and I also, it

18  resonated with me, the previous comment about, exactly,

19  what is the goal of each tier, and are they

20  representing different kinds of questions, or are they,

21  really, just progressions of better information.

22  Because, in the exposure tier, it states pretty clearly

23  that they'll be using interpolated hourly NO2

24  concentrations.

25	It says measurements, but presumably,

Page 144

1  I missed it on Terry, but anyone should have, should

2  feel free to comment on the approach they're using for

3  exposure assessment, particularly the tiered approach.

4  Do we have any more comments?

5	DR. HATTIS: Yeah, I just want to just

6  reinforce that, you know, I do think that if you stop

7  at the some of the lower tiers, you'll probably not

8  produce the kind of information that will later be

9  needed in, at least, impact assessments, if not the

10  primary decisions.

11	DR. HENDERSON: Good, and I believe Frank

12  Speizer had a similar comment that he would be

13  disappointed if you stopped at tier one.

14	DR. GORDON: Rogene, I - -

15	DR. HENDERSON: Okay, Terry.

16	DR. GORDON: I might be making myself

17  more confused, but on page 22, it has a long-term

18  exposure approach, as if it's going to be using annual

19  averages.  And then, when I get to page 31, I was going

20  to talk about some, one health comment.  It says

21  they're not going to use that in the health risk

22  assessment.  So, if that's true, why are you going to

23  do this work?  I don't agree with not doing it,

24  actually.

25	DR. GRAHAM: It was probably found, I

Page 143

1  there'll also be predictions, because they'll be over

2  space as well.  And, you know, that is just a, I mean,

3  we're, as Tim alluded to, we're struggling with that

4  here in the project we're doing.

5	That's a huge, huge undertaking to do that

6  well.  So, there has to be a number of simplifying

7  assumptions to even do it at all.  And, of course, you

8  know, then you start to question how good it is.  And,

9  again, it depends on the purpose.  I guess the only

10  other comment, with respect to the exposure modeling

11  is, it seems to me that the, well, when it moves to the

12  level of the Monte Carlo simulation with the APEX

13  model, that could be expanded to incorporate some key

14  assumptions.

15	So, not just doing sensitivity analyses,

16  looking at one or two different assumptions; but

17  incorporating explicit structure for what those

18  different assumptions or models could be.  And, then,

19  getting a more explicit estimate of the uncertainty

20  that has to do with more than just the distribution, or

21  just the underlying assumptions, but also variability

22  in what those assumptions are.

23	DR. HENDERSON: Thank you, Lianne.  Now,

24  do others, as I say, these names listed here are just,

25  trying to divide up according to interest.  Obviously,

Page 145

1  don't want to say probably.  It was founded in the

2  current form of the standard.  That is, it's a annual

3  average.

4	DR. HENDERSON: Is that the answer

5  you're, I mean, does that answer your question?

6	DR. GORDON: Tradition, yeah.

7	DR. HENDERSON: Yeah, okay.

8	MR. RICHMOND: Well, one of the, I mean,

9  this is sort of the linkage to get back and forth

10  between the exposure and risk.  One could envision

11  doing a long-term, addressing long-term air quality in

12  the tier one, or long-term exposure, doesn't mean that

13  quantitatively that we have enough information to

14  address, or we don't, you know, depending on both

15  causality and the level of information on concentration

16  response relationships from the epidemiology, do we

17  have enough to make a credible quantitative risk

18  assessment, not qualitative con-, you know, concerns

19  about the health endpoints that may be shown, but

20  enough to, basically, move to that next step

21  quantitatively.  And, so I mean, there could be very

22  much a distinction between whether we do long-term air

23  quality or exposure, as opposed to a tier two,

24  quantitative, long-term risk assessment.

25	The question on benchmark is it's difficult,

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Page 146

1  given the issue that Doug and others have brought up,

2  the epi studies long-term don't tell you, like the

3  clinical studies, what's a benchmark exposure level.

4  You don't know what the exposure was.  You know what

5  the ambient monitors were.  That's all.

6	DR. HATTIS: Well, because you don't,

7  they don't directly tell you about it, they certainly

8  give you a clue, from which you can reason, given your

9  other information about what they're likely to have

10  been.

11	MR. RICHMOND: It, again, depends,

12  there's all sorts of questions about is it really the

13  cumulative long-term average, or is it, as Dr. Crapo

14  mentioned earlier, is it that someone sees a peak so

15  many times per week.  There's all sorts of

16  possibilities, from a health standpoint, in terms of

17  what the real, underlying cause of those long-term

18  effects are.

19	DR. HATTIS: Yeah, and I think you need

20  to fairly characterize those uncertainties by doing it

21  a couple of different ways, and say, okay, what are the

22  differences in expectations that we get from these

23  different possible states of the world.

24	DR. HENDERSON: Thank you, Ed?

25	DR. AVOL: I submitted some written

Page 148

1  the current standard?

2	DR. HENDERSON: Yeah, go ahead, Harvey.

3  We talked about that earlier.

4	MR. RICHMOND: Yeah, I thought we had

5  discussed that about twenty minutes ago, but - -

6	DR. HENDERSON: Yeah.

7	DR. SHEPPARD: Yeah.  Well, maybe, okay,

8  maybe I just missed it.

9	MR. RICHMOND: Oh, okay, but, well, what

10  I laid out is, it is a problematic challenge to, you

11  know, to deal with how do you assess the exposures or

12  risk just meeting the current standard.  There are

13  different approaches.  One is to use historical air

14  quality when the levels were just meeting the current

15  standard back typically in the 90's for some of these

16  example urban areas.

17	The other approach would be to rec-, you

18  know, do some statistical adjustment just like we've

19  done in ozone and PM, where it's been to ra-, you know,

20  adjust things, air quality adjustment procedures to

21  adjust the distributions downward to meet a standard,

22  but effectively, rolling up distributions to just meet

23  the standard.  And there are different ways you could

24  do that, as to whether it's proportionately all the

25  monitors, or whether we make distinctions between the

Page 147

1  comments.  I won't go through all those, but one area I

2  did want to ask about was the issue of the Tiger

3  mapping, in terms of the road designations, and in

4  terms of modeling and assessing the portion of

5  population that may be within or near roadways.

6	There are ways, I point out one way that we,

7  sort of, found out there was a problem and what we did

8  about it, but there are other ways to do it.  But I

9  just wanted to get some confirmation that, in fact,

10  you're either going to ground troop it or do some

11  sensitivity analysis or something, or move to something

12  other than that.

13	DR. GRAHAM: I'm sorry, I was looking at

14  my notes.  Yeah, we are aware of that data as well.

15  And, it's not to say that we were just going to look at

16  the one data source that I mentioned, but the Tiger

17  road, it wouldn't be exclusive.  But the Tele Atlas

18  would be used.

19	DR. HENDERSON: Are there any other

20  comments or questions people have about the exposure

21  assessment section?

22	DR. SHEPPARD: Yeah, this is Lianne

23  Sheppard.  I have another question, and what does it

24  mean to look at exposure for just meeting current

25  standard, when so many of the measurements are below

Page 149

1  near roadway and non-near roadway monitors.

2	So, we were looking for feedback from the,

3  particularly, the air quality experts on this

4  committee.

5	DR. SHEPPARD: So, I guess, my question,

6  then, is, should we even do that, since the mo-, since

7  the current data are below the standard.

8	MR. RICHMOND: Right, the other

9  alternative is, then, we, otherwise, have no exposure

10  or risk associated with the current standard.  It would

11  really be the recent air quality and what standard that

12  would be associated.  So, if a place that only maximum

13  has .03 today annual average, that they were,

14  basically, looking at standards at that level and

15  below.  That's the choices we face, and you know.

16	DR. CRAWFORD-BROWN: Rogene, may I,

17  several points have touched on that.

18	DR. HENDERSON: Yes, go ahead, Doug.

19		DR. CRAWFORD-BROWN: This worries me just

20  a little bit, because the question comes up as to what

21  do you mean by meeting the standards.  If what you mean

22  by meeting the standards is that everybody goes to

23  0.053, then that's one thing.

24	But my argument is going to be, that when

25  people meet the standards, kind of like in water, it's

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Page 150

1  the same issue, they put in place mitigation strategies

2  that do drop significant areas well below the

3  regulatory limit, and that is part and parcel with

4  meeting the standard.

5	So, I don't think that a scenario in which

6  everybody has gone up to .053 is, in fact, a scenario

7  that is meeting the standard in the way that meeting

8  the standard actually plays itself out.

9	MR. RICHMOND: Yeah, let me clarify that.

10  When we say meeting the standard, standards, typically,

11  have been implemented by, for example, large regional

12  areas.  The CMSA basis, it's not just L.A. County, but

13  it's the L.A. at CMSA is, typically, a definition for a

14  non-attainment area.  When we say adjusting the air

15  quality, we mean at the highest monitor in that area.

16  We're not talking about using or adjusting air quality

17  so that every single monitor in an area is just at the

18  current standard.  It is the design monitor within that

19  urban area.  So, it's like, for the whole New York

20  area, if we did New York, or Philadelphia.

21	DR. CRAWFORD-BROWN: Okay, so in your - -

22	MR. RICHMOND: So that, so none of it,

23  nowhere have we ever adjusted air quality in any of our

24  analyses in the past so that all monitors with an area,

25  when we do just meeting standard scenarios, it means

Page 152

1  one of the things, having looked at your comments, we

2  may want to, at least, take maybe the worst case

3  situation, maybe it's Los Angeles, and look, you know,

4  look at the mobile models.  What if we were to double

5  vehicle things, would we still have a problem?

6	We still might not come up to that level

7  given control technologies and given stationary

8  technologies, that was the industry argument, that even

9  given what's in place and can't be rolled back, that

10  you can't envision the scenario that gets there, but

11  that's something we could look through modeling in a

12  more limited number of areas.

13	DR. HATTIS: Yeah, and I think that's a

14  reasonable alternative, to say, okay, what is the worst

15  possible deterioration that we can reasonably imagine

16  under the current scenario.  I mean, that can include,

17  you know, non-attainment of ideal compliance with

18  everything, but.

19	DR. LARSON: Harvey, this is Tim again.

20  When your scenario of just meeting the standard is

21  going to based on the actual location of the, the

22  worst, the highest EPA monitor in that area?

23	I mean, what if you did your modeling

24  exercise and found that there were a whole bunch of

25  places that currently don't meet that standard within

Page 151

1  only at the design monitor, and what are the

2  relationships at the other monitors as they flow up and

3  down.

4	DR. CRAWFORD-BROWN: Oh, okay, okay.

5  Okay, there's something you said earlier that made me

6  think it was different from that.  Thank you.

7	MR. RICHMOND: All right, okay.

8	DR. HENDERSON: Well, and, I think Ron

9  brought up the important point.  You wouldn't want to

10  say that the risk associated with meeting the current

11  standard, or the current risk when it's, actually,

12  lower. So, I, that's, you could misinterpret that.

13  Dale, did you have something?

14	DR. HATTIS: Yeah, I think the concern is

15  to have a realistic scenario.  And in the, the

16  realistic scenario that could get you to back up to the

17  roll up, type methodology that you want to think about,

18  is imagine a future of possible growth in traffic or

19  other things that you could reasonably imagine, where

20  you could be deteriorating the air quality enough to

21  get you to near the, near compliance with the current

22  thing.  So, I think it may well be that your roll up

23  scenarios are the easiest thing to do along those

24  lines.

25	MR. RICHMOND: Right, and in that vein,

Page 153

1  the urban area.

2	MR. RICHMOND: Well, what you, are you

3  talking about the exposure modeling, air qu-, I'm a

4  little lost as to which point - -

5	DR. LARSON: Yeah, I mean, your, yeah.  I

6  mean, is it based on the current, the - -

7	MR. RICHMOND: Whether you meet the

8  standard, by definition, is at the monitors.  It, you

9  know, the mo-, we're supposed to be, have taken that

10  into account.

11	We realize in setting the CO standard and the

12  ozone standard that, no, the highest level may not, you

13  know, depending on the pollutant, may not be at the

14  monitor, but designing scenarios for alternative

15  standards is based on the monitoring network, not,

16  we'll then look at the implications through exposure

17  analysis in modeling to see what's the distribution of

18  exposures in the population, no matter where they are,

19  but it is based on simulating standards that are met at

20  the monitoring network and by definition of the

21  standard at the design monitor.

22	DR. LARSON: Okay.

23	DR. HENDERSON: Okay, does anyone who is

24  on the phone have any comments?  I don't want to ignore

25  you.  I've already heard from Lianne and Tim.  Okay, I

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Page 154

1  suggest that there seems to be a strong move towards

2  lunch.  We have lunch next door.  I would like for us

3  to use this as sort of a working lunch.  Maybe be

4  prepared to start our discussions again at 1:00 in

5  here.  You can bring your lunch in here and eat, or you

6  can eat there, or do whatever you want to do.  But I'd

7  like to start the discussions at 1:00 and Vanessa has

8  something.

9	DR. VU: Since we are short of time, I'd

10  also like to invite OAR representatives to join, grab a

11  lunch here so you can quickly go back here.

12	DR. CRAWFORD-BROWN: With us?

13	DR. VU: No, no, I mean, get the lunch

14  and come back here at 1:00, since it's a, you know,

15  sandwich buffet, whatever.

16	DR. CRAWFORD-BROWN: They get in line

17  first, then.

18	DR. HENDERSON: Well, I think that's

19  great, so we will begin our discussions here at 1:00,

20  and you can use your time now to eat in there or eat

21  in, to bring it in here,  whatever you want.

22  (WHEREUPON, the morning session was concluded.)

23	DR. HENDERSON: We want to, very good.

24  Doug is my bell ringer.  We want to get started

25  discussing this last section of the methods document.

Page 156

1  is data from several studies looking at children's lung

2  function, for example, which is a long-term, sort of,

3  exposure.  And so, it seems like there needs to be some

4  reconciliation.

5	Yesterday, we had some discussion about,

6  well, perhaps maybe there is a need for a short-term

7  NO2 standard.  But, so, I just want to offer that up as

8  a comment for discussion, or at least for

9  consideration.  In any case, here, it just, sort of,

10  says, well, so, we're just not going to do it.  But I

11  think it needs to be, at the very least, it needs to

12  be, sort of, just supported or substantiated or

13  something.

14	The other comment, which is a small comment.

15  I, also, have some small written comments.  But,

16  there's a, in section 4.3, there's a discussion about

17  health responses.  And again, it, sort of, focuses more

18  on short-term effects.  And, sort of, disregards long-

19  term losses in lung function.  And yet, based on what

20  we talked about yesterday and today, one of the

21  conclusions in the ISA is going to be that long-term

22  lung function is an important issue.  So, it seems like

23  the two documents are not going to be quite consistent.

24	MR. RICHMOND: In response, we said

25  preliminary, based on what we saw in the first draft

Page 155

1  That is the one on the health risk assessment.  And I

2  think there'll be a lot of comments on that.  A lot of

3  people interested in it.  John Samet is calling in a

4  1:45, so we'll have his comments later.

5	But, we have all of our Air Office crew here.

6  Well, that was a great lunch, and I thank Vanessa and,

7  who has already left for arranging it for us.  That was

8  a nice way of handling things.

9	So, now, we're going to open our discussion

10  on the health risk assessment approach, and what, and

11  offer it, our advice to the Agency as to whether we

12  think they're using the right approach, or if it could

13  be improved.  And Ed, you are one of the first

14  discussants.

15	DR. AVOL: Okay, thank you.  I have, I

16  guess, two comments.  One has to do with the risk

17  assessment scope overview itself.  The, what's laid out

18  on page 31 talks about how the draft ISA leads to a

19  suggestion that the strongest health findings are for

20  one-hour and twenty-four-hour averaging times, so

21  there's not going to be any risk assessment for longer

22  term exposures.  And that's disquieting, I guess.

23	The current standard is an annual, long-term

24  standard.  The document says, or this document says,

25  we're only going to look at short-term exposure.  There

Page 157

1  ISA, which we're waiting, and we said we will make the

2  assessments based on the second draft ISA that will be

3  coming out before the risk assessment.  So, we will

4  look at and work closely with and see it to see how

5  those issues are addressed in the second draft ISA.

6	DR. HENDERSON: Okay, now, is, John

7  Balmes, are you on the phone?

8	DR. SHEPPARD: Rogene, I think he said he

9  was coming back at 2:15.

10	DR. HENDERSON: Oh, that's right.  I knew

11  that.  I'm sorry.

12	DR. SHEPPARD: Can I take his place?  I'm

13  leaving kind of earl-, soon.

14	DR. HENDERSON: So, would you like to

15  make your comments now?

16	DR. SHEPPARD: Yeah, and I'd like to

17  follow up on Ed's comment, because one of my main

18  concerns was for each of the tiers of the risk

19  assessment is that, I think we need to have very

20  clearly stated criteria for what particular outcomes

21  and populations and so on will be used.  And those

22  should be specified in advance.  And presumably, they

23  will come from the results of the ISA, as has been

24  stated.  But, the criteria for choosing them, for

25  instance, would it be only the out-, the outcomes that

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Page 158

1  are measure-, assessed as likely causal, as an example.

2  Those, then, get brought forwarded to the risk

3  assessment.

4	My other, fairly major comment, with respect

5  to the risk assessment is, I think it needs to be

6  expanded to have three tiers.  And the first tier

7  should be the qualitative risk assessment.  And, so,

8  that it doesn't, it becomes as important as the other

9  tiers, and it also becomes the foundation for the

10  quantitative risk assessment.

11	So, all the different outcomes are reviewed,

12  but some of them, presumably, can't be easily

13  quantified in a quantitative risk assessment, but

14  they're still important, and they get discussed in the,

15  in what I would suggest would be the first tier, which

16  is the qualitative assessment.  And then, some of them

17  meet the criteria for being brought forward for

18  quantitative assessment, and they, therefore, go up to

19  the next levels.  So, I think that's a fairly  major

20  change in the organization that I recommend.

21	I think the criteria for even discussing the

22  quantitative or even conducting the quantitative risk

23  assessment need to be specified in advance as well in

24  this document.  And I, actually, recommend that all

25  tiers of all, both the exposure and the risk

Page 160

1	I guess, looking back at the ozone criteria

2  document, when we had a fair amount of discussion about

3  the linear versus logistic function, you ended up

4  using, doing a new analysis, which had different

5  weights for the linear and the logistic function.

6	That is an example of moving in that

7  direction.  It was presented more as a sensitivity

8  analysis, but the, you know, that's the, that's what

9  I'm thinking, that a lot of, a number of different

10  assumptions and uncertainties of those would be

11  incorporated into the estimates that are produced.

12	MR. RICHMOND: But again, that was a

13  sensitivity analysis.  There wasn't an assignment of

14  how much weight to put on the different choices.  We

15  put forth a base case assumption, and we looked at the

16  impact of alternative assumptions.  I'm hearing you say

17  that you want us to do more than that.  I'm still left

18  puzzled as to what you would be recommending us to do

19  differently.

20	DR. SHEPPARD: Okay, I'll try to

21  articulate that more clearly in writing.

22	DR. HENDERSON: Okay, is that all you had

23  to say right now, Lianne?

24	DR. SHEPPARD: Yes.

25	DR. HENDERSON: Okay, thank you.  And

Page 159

1  assessment, be discussed, even if the discussion is

2  that these are the reasons why we can't do this, if

3  that is the ultimate decision.

4	From what I've seen, I think that all tiers

5  should be done, at least so far, but that remains to be

6  seen.

7	And then my last, fairly major comment is the

8  quantitative risk assessment needs to, also,

9  incorporate some integrated uncertainty assessment that

10  goes beyond the  sensitivity analysis.

11	DR. HENDERSON: Okay.

12	MR. RICHMOND: Just on the last point,

13  this is Harvey Richmond.  Could you clarify what

14  approaches, either in written comments or today, when

15  you use the word integrated uncertainty assessments,

16  what you would envision that, what approaches being

17  used to carry out such integrated assessments?

18	DR. SHEPPARD: Yeah, and the devil of

19  those, that kind of thing is in the details, of course.

20  I'm sure that's why you asked the question.  And I

21  guess, the idea here is that the, and I'll try to

22  expand a little bit more than I have already.  The idea

23  is that the, we go beyond sensitivity where we assume a

24  different set of fixed assumptions to allowing for

25  multiple different assumptions.

Page 161

1  then, James Crapo, do you have something?

2	DR. CRAPO: Yeah, I think I've made most

3  of the points, so to make the, I like the risk

4  assessment model and the health endpoints.  I thought

5  you were choosing the appropriate ones, and I like,

6  particularly, that you were, included a focus on short-

7  term exposures and short averaging times.

8	And, I assume, if I read it correctly, you're

9  going to continue that as you do the tier two

10  epidemiology.  You're also going to look at the

11  possibility of using correlations with something other

12  than the national average, annual average, but rather

13  the short-term exposure peaks, which I'd really

14  encourage that.

15	Because I think that one of the most

16  important outcomes that can come out of this analysis

17  to help us develop data that would convince us it's

18  important to change the form of the standard or not.

19  Because I think that, I think form of the standard is,

20  probably, one of the more important questions to

21  address at this point in time.  And I'd like to see the

22  risk assessment provide us better information to make

23  an informed decision on that.  But I think that's

24  already part of your goal as I read it, so I'm very

25  pleased with what I see.

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Page 162

1	DR. HENDERSON: Thank you, James.  Is

2  Steve Kleeberger still here?  I don't see him.  He's

3  not, he wasn't going to be on the phone, was he?

4	DR. NUGENT: That's correct, and he did

5  send an email this morning saying he may be unlikely to

6  be here.

7	DR. HENDERSON: Oh, okay.  Then we'll go

8  on to Kent Pinkerton.

9	DR. PINKERTON: Okay, again, I think this

10  is a really well-executed document.  I think the

11  concern that I have is one that was also expressed by

12  Frank Speizer.  And that's just the concern that with

13  the tiered approach, that one may be tempted to stop at

14  tier one and not go beyond.  And I think that becomes

15  problematic, because there's such rare occurrences of

16  excursions of above the set standard, that one could

17  argue, well, there is no need to go to tier two and

18  look at these potential health effects.

19	But since we see so many instances of

20  significant health effects associated with ambient

21  concentrations of NO2 that are well below the

22  established standard, that I think it's just important

23  that that be really emphasized, that many of these

24  studies really need to go beyond just tier one and go

25  on to tier two and, occasionally, to tier three.

Page 164

1  national priority - -

2	DR. HATTIS: - - but I do think that

3  getting an idea of the quantitative significance of the

4  health effects that you think are likely is important

5  from a national priority setting standpoint.  You know,

6  one, of course, your main job is to inform on decisions

7  about the revision of the criteria, this particular

8  criteria standard.

9	But, also, it seems to me, that you are also

10  feeding into a national discussion about how we should

11  devote our resources to changing the mix of air

12  pollutants that we are exposed to, and, as well as

13  other problems.  And so, trying to be as thorough as

14  you can about allowing people to project national

15  impacts is an important function, okay.

16	Because this isn't going to stop at the, with

17  your meeting of the deadlines that you have in front of

18  you.  And, you know, people are going to continue to

19  try to understand how, you know, how they should be

20  devoting resources to this problem.  Because of that,

21  in part, I think you ought to really, seriously,

22  consider stretching a bit to include the kind of

23  effects that are based upon the chronic observations,

24  particularly the children's lung function growth.

25	Let me say that that's important because it

Page 163

1	But, again, I think the way it is written,

2  the health endpoints seem to be very appropriate.

3  Again, keep in mind, as you look at susceptible

4  populations, again, to keep in mind children, those who

5  have asthmatic conditions.  Also, I don't know if we've

6  really reached a point at this point in time, but are

7  there potential differences based on gender, with

8  regard to the health effects associated with nitrogen

9  oxide exposures.

10	Again, I think, some of my questions about

11  why only cities and not areas that are not city or

12  population based are not being included, but I think,

13  Donna, you helped me understand that a little bit

14  better.  So, and I think those are, pretty much, the

15  extent of my comments.

16	DR. HENDERSON: Thank you, Kent.  Dale

17  Hattis observed that I'm not too sharp here this

18  morning.  I skipped him.  That was not intentional,

19  Dale.  So, we'll hear from Dale right now.

20	DR. HATTIS: That's all right.  Anyway, I

21  want to second the thing that some of the, many of the

22  comments that, in fact, Kent Pinkerton has just made.

23  But just to say, a little more strongly.  I'm going to

24  be really disappointed if you stop at tier one.  Of

25  course, avoiding disappointing me is not a huge

Page 165

1  sets, if, in fact, it's true that the NOx or NO2

2  changes that, that sets the baseline for lung function

3  over a lifetime, which deteriorates, which grows

4  through childhood and early adulthood, and then starts

5  to deteriorate over time until you get to less and less

6  function as you get to our age.  And so, that's, and

7  that is, in fact, directly related to mortality as

8  well.

9	So, that has, sort of, long term implications

10  for lifetime function and survival that might not be

11  apparent from just saying, okay, well, we're going to

12  lose X percent of FEV1 for kids who have more than they

13  need to begin with, you know.

14	So, I think that's, so I think that's a

15  reason to take that possibility seriously, and to, it's

16  worth a little bit of a stretch, if you have to admit

17  that you have three or four or even tenfold uncertainty

18  in that, well, okay, it might still be important.

19	DR. HENDERSON: Thank you, Dale.  I'm

20  going to ask Ronald Wyzga to make his comments, and

21  then we'll open it up, and everybody can make comments.

22	DR. WYZGA: Thank you.  I think the plan

23  as written is a very good plan.  I think it's very

24  thorough, very thoughtful.  I think the difficulties

25  are going to be in the implementation.  It's a

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Page 166

1  formidable task.  You have a tremendous challenge, and

2  I think that to come up with something that's going to

3  be, with your resources available and with the data

4  available, is going to be, accepted by a wide community

5  is going to be a challenge.

6	But, I applaud the approach you've taken.  I

7  think, when I think, you know, particularly, tier

8  three, and you look at the current epidemiology

9  studies, they tend to look, they tend to use linear

10  models, which suggest that there's no threshold.  And,

11  that's one area, what worries me particularly, where

12  you're looking at the just meeting current standard, in

13  the sense that if an area is still well below any

14  standard or proposed standard, because you're using a

15  linear model, you're going to overestimate the risks

16  for that area.

17	And I really worry that that could be

18  misinterpreted, and I urge you to, sort of, think about

19  both how you present that, and is there some way to get

20  around that problem.  I don't have an obvious solution

21  to it.  I think you've done some thinking about it, but

22  I urge you to think further about it, and to the extent

23  that you can't resolve it, it's going to be very

24  important how you present the results so that they

25  don't mislead the public.  But, otherwise, thank you, I

Page 168

1  point in time.

2	DR. HENDERSON: I think that's the

3  problem of double counting, are we double counting.  I

4  mean, how many deaths, how many times can a man die.  I

5  mean, I'm just joking, of course, but what I mean is -

6  -

7	DR. HENDERSON: - - is there any double

8  counting.  I think that's a logical question.

9	MR. RICHMOND: No, Rogene, no, we didn't,

10  really, indicate mor-, we didn't include mortality in

11  that preliminary list.  It's morbidity endpoints, and

12  the hospital admission studies, that have NO2 may, or

13  may not, be some of the same studies that pointed to

14  ozone or PM where they were using - -

15		DR. CRAWFORD-BROWN: Yeah, I don't know.

16  I just get a sense that I keep seeing the same kinds of

17  studies appear in documents, and, you know.

18	DR. HENDERSON: Yeah, you're right, it's

19  the morbidity we're concerned about, but, okay.  Is

20  there anybody on the phone who wants to make a comment

21  and has not?  We are - -

22	DR. POSTLETHWAIT: I think Ted wants to

23  comment.

Page 167

1  think you've done a great job.

2	DR. HENDERSON: Are there other people

3  who want to make comments on the health effects.  Doug,

4  I think does.

5	DR. CRAWFORD-BROWN: Just one small one,

6  and it's more of a medit issue.  As we've been having

7  this discussion about the epidemiological studies, and

8  the contribution of NOx and ozone and PM and so forth,

9  this,  probably, is a time for you to start thinking

10  about looking at, what I would sort of call, the mass

11  balance of the various risk studies that you're doing

12  to see if they add up to something more than the total

13  decrement that's seen in the epidemiological studies.

14  I just wonder, if you add it up, what you calculate for

15  NOx, and what you calculate for ozone, and what you

16  calculate for PM.

17	They're all based on, sort of, the same kind

18  of epidemiological results from which, we hope, we're

19  tearing apart the various relevant contributions, but I

20  just don't know.  I don't know.  If you added them up,

21  would this be something like TRIM, for example, where

22  TRIM had problems with more stuff coming out of a

23  compartment than ever went into the compartment, you

24  know.  It's sort of a mass balance, kind of, thing

25  there, that I thought I would find interesting at some

Page 169

1  quick.  We've got all the time in the world.

2	DR. RUSSELL: No, I prefer making it

3  quick.  Just, carrying on something from what James

4  said is that, if we're going to be looking at a,

5  possibly, a new standard, when you look at your table

6  two, or any of the other analyses, just keep in mind

7  that, maybe look at various alternative standards and

8  forms of standards for our assessment.

9	DR. HENDERSON: Yes, I think that would

10  be very good for the analysis to see.  Well, it's been

11  a very productive day and a half.  I'm, I really want

12  to thank everybody for working so hard, and for

13  staying, most of you staying to the end of the meeting.

14  And, I hate that we're going to miss John Samet,

15  apparently, but he has written, has he sent in his

16  comments, his written comments?

17	DR. NUGENT: I don't think we have

18  comments on the methods document, but his assistant

19  said he'd be on the line at 1:45.  This was scheduled

20  for 2:15 on the agenda.

21	DR. HENDERSON: Oh, I know, I know the

22  problem, but I'm just sitting here.  I don't think

23  people want to sit fifteen minutes to wait, I mean.

24	DR. HATTIS: He can sign on and say his

25  piece and that's fine, but we won't hear it.

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Page 170

1	DR. HENDERSON: But you all will be a the

2  airport.

3	DR. CRAWFORD-BROWN: I think it's $14.38

4  we'll earn during that time, so keep at it.

5	DR. HENDERSON: Okay, well, it, I do

6  value John and, the two Johns comments, but I think

7  that they have, since we're not trying to reach a

8  consensus, I mean, we're trying to get all of

9  everybody's comments, that we can just get their

10  written comments, which is what is needed.  And again,

11  if you haven't turned in your written comments, well,

12  be sure you do that.  Ed is wanting to say something.

13	DR. AVOL: Yeah, I would just ask that if

14  the Agency staff have any questions, based on what

15  they've heard, that they would like to get

16  clarification on.

17	MR. RICHMOND: I have one.

18	DR. HENDERSON: Okay.

19	MR. RICHMOND: We put forth, I know it's

20  preliminary for putting aside the long-term children's

21  health study, but for short-term, from the clinical, we

22  identified a preliminary range of .2 to .3.  Are we in

23  the right ballpark, or do the people who are familiar

24  with the clinical evidence think it's something other

25  than that range for one hour, based on the controlled

Page 172

1  we're - -

2	DR. CRAPO: - - and homes and things like

3  that.  So, you're going to extrapolate that that might

4  be there and use that.  I like that idea.

5	MR. RICHMOND: But I'm saying, on the

6  health side, are we in the right range - -

7	DR. CRAPO: On the health side, but the,

8  so you're going to, actually, look to see if there's

9  health effects, and you're going to model with that,

10  perhaps, might be that will be - -

11	MR. RICHMOND: Well, we're going to see

12  if there are exposures of, what we call, our term is

13  exposures of concern, which doesn't mean that everyone

14  who sees that exposure will, necessarily, be affected,

15  and we've explained - -

16	DR. CRAPO: I know, and I understand

17  that.  But this going to be all extrapolation data,

18  based on modeling from - -

19	MR. RICHMOND: Model data that's a

20  combination of both ambient and modeled inputs through

21  the exposure model.

22	DR. CRAPO: I think that's a very good

23  idea.  I'd love to see the data, 'cause it addresses

24  exactly what I've been talking about.

25	DR. HENDERSON: And I think he was,

Page 171

1  studies that we have, based on the evaluation in the

2  ISA.

3	DR. CRAPO: I have a question, what do

4  you mean by .2 or .3.  Are you looking for, are you

5  going to model the - -

6	MR. RICHMOND: A level of concern, if

7  you're going to compare either air quality or

8  exposures.  We did this in ozone, as you remember.

9	DR. CRAPO: Right.

10	MR. RICHMOND: But we had .06, .07, .08,

11  so we don't have to settle on a single level, but is

12  that lev-, a range at which we, at least, are

13  interpreting our evaluations, because - -

14	DR. CRAPO: All right, well, let me be

15  sure I unders- -

16	MR. RICHMOND: - - I think that that's

17  where the clinical studies start to, kind of, you know,

18  the lowest level at which effects in asthmatics are

19  being observed.

20	DR. CRAPO: I like this, except I'm not

21  sure how you're going to model it.  Because, in fact,

22  we don't have any documented exposures at that level

23  from the air monitoring stations.  You have to

24  extrapolate into cars and buses and - -

25	MR. RICHMOND: Well, that's what

Page 173

1  Harvey was probably asking Ed clinically that was what

2  you would consider appropriate levels.  Haven't you

3  done studies with children?

4	DR. AVOL: Not children in chambers at .2

5  or .3, no.  I mean, the work we did in chambers was a

6  higher, was with adults.  So, I don't know that it's, I

7  can directly relate to this.

8	MR. RICHMOND: You talking about, there

9  were a number, there's a table summarizing a number of

10  asthmatic studies that go down as low as .2.

11	DR. AVOL: And so, I mean, in that sense,

12  again, as James said, I mean, I think, what you lay out

13  is fine.  My, not withstanding my previous comment

14  about long-term studies, long-term is more - -

15	DR. HATTIS: Let me make a somewhat

16  modest further comment on that, and that is that, you

17  should, when you measure a statistically significant

18  decrement at lung function, or a change in the

19  responsiveness, you're talking about, not necessarily,

20  a uniform response or a uniform susceptibility within

21  that group that's measured.

22	And we have prior information about how

23  variable people are in their susceptibility in a large

24  number of other context.  We have a database of that

25  that's on our website.

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Page 174

1	But, anyhow, so, in pharmacodynamic

2  variability, in that kind of local responsiveness,

3  happens to be, tend to be more variable than lots of

4  other stuff, basically, of the order of geometric

5  standard deviation of three or a bit more for that kind

6  of variability, if I remember correctly.

7	But, you know, so, you can, in fact, by

8  imposing a, kind of a log-probit function, with that

9  amount of spread, you can make a, just as you can make

10  distributional characterizations of the exposures, you

11  can make distributional characterizations of the likely

12  variability in susceptibility, and get something more

13  that may, in fact, you know, say, you know, for your

14  first percentile population, you might have sensitivity

15  that's outside of the range that you've measured for

16  the average concentration that's capable of changing

17  this group, right.

18	And so, any how, so, it is possible to do a

19  slightly more involved analysis that, maybe, take you

20  half hour rather than fifteen minutes, that you might

21  do for the una, with single variable analysis.

22	You also asked the question about how do we

23  do an integrated, you know, characterization of

24  uncertainty.  And there's a, this is, perhaps, a longer

25  answer, but basically, you characterize the

Page 176

1  there are ways of dealing with this, although, they do

2  require a bit of creativity and maybe creativity is a

3  bad word.

4	MR. RICHMOND: A lot of creativity on

5  work.

6	DR. HATTIS: Yeah, you know, but,

7  nevertheless, you know, it's possible.  And I think

8  it's possible without inordinate resources.  I mean, I

9  think of the, you know, the poor guy who's over in the

10  other part of ORD dealing with trichloroethylene and

11  he's having to deal with Markov chain Monte Carlo

12  simulations of to do uncertainties and variability for

13  trichloroethylene and project from animal data to

14  people.  And, you know, and he's large-, mostly one

15  guy, you know.  So, lots of people have, you know,

16  resource constraints, but you know, it's a hard problem

17  to do quantitative assessments.  But it can, you know,

18  it's not impossible.

19	DR. HENDERSON: Thank you, Dale.  You

20  almost took up the fifteen minutes, but not quite.

21	DR. HATTIS: I'm sorry.

22	DR. HENDERSON: No, it's okay.

23	Yeah, I can just change it.  Kent, go ahead.

24	DR. PINKERTON: This is a, just a

25  question about, under the risk assessment overview, you

Page 175

1  uncertainties in the exposure, and it's faster to say

2  that than to do it, and the uncertainties in the

3  susceptibility and concentration response slopes and

4  other things of that sort, and you, basically, convo-,

5  you know, basically, convolute those two with a Monte

6  Carlo simulation.

7	But you do have to, you know, sometimes these

8  are better done than other times, and it is a matter of

9  an evolving art as to how to choose the distributions

10  that you use to characterize each of the uncertainties.

11	MR. RICHMOND: And in this area, it is

12  not straightforward.  The clinical data, even when I'm

13  suggesting .2 to .3, some asthmatic studies, controlled

14  studies, have found effects.  Some have them have been

15  repeated, and haven't found the same level under the

16  same kind of conditions.  So, this is no easy matter to

17  assign probability or simply pick distributions out.

18	DR. HATTIS: Right, and so, you might

19  want to, you know, do some combined analysis that says,

20  well, there's some chance that the population

21  distribution of susceptibilities is in this range, and

22  some with this kind of mean in standard deviation, and

23  some chance that it's in some other range that would be

24  compatible with the observation that, you know, was not

25  found in a particular population.  So, anyhow, so,

Page 177

1  had mentioned there that the EPA would not develop risk

2  estimates for NO2 related effects associated with long-

3  term NO2 exposures.  And, I think you stated that you

4  wouldn't do that, based on the fact that the findings

5  are inconclusive, or at best, suggestive.  And I'm just

6  wondering, does that mean that you think that in doing

7  short-term exposure assessments, you might be able to

8  address issues that may have, with regard to NO2

9  exposures, that may have long-term effects?

10	MR. RICHMOND: No, I don't think that's

11  what we're saying.  One, as Lianne mentioned, there, we

12  have applied in the past and was envisioning here,

13  it's, selecting which health endpoint is first looking

14  at causality, and in the past, we have and proposed

15  here to do things that were likely causal, not to

16  quantitate risk, or develop risk, quantitative risk

17  estimates for things that were only suggestive or

18  limited whatever final terms the ISA ends up.

19	So, we are, that is, part of the screening

20  criteria in terms of determining how far we go, and

21  then, looking at what kind of information we have as

22  well, in terms of even once you get past.  There were

23  endpoints for ozone like inflammation, which were

24  clearly likely causal, or causal.

25	But we didn't have sufficient information to

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Page 178

1  generate, we felt, a credible exposure response

2  relationship, and we still considered that in the

3  review, that endpoint, in the discussion and

4  evaluation, but we didn't do a quantitative, let's

5  produce how many people have different degrees of

6  inflammation.

7	So, just because we don't quantitate

8  something in terms of producing some number of people

9  have this many health effects, doesn't mean we're

10  ignoring the other health endpoints.

11	DR. HENDERSON: I have a question that

12  has occurred to me as I sit here.  I seem to remember

13  that some of the toxicology studies suggested

14  development of a tolerance to NO2, am I right, does

15  that happen, or am I getting it confused with ozone

16  or - -

17	MR. RICHMOND: I'll defer to Ed.

18	DR. HENDERSON: Are there development,

19  are there animal tox studies showing development of

20  tolerance?

21	DR. PINKERTON: I think there are, yes.

22  Oftentimes, NO2, as people are likely to be aware,

23  behaves in a similar manner to ozone.  It's just that

24  you have to have  much higher concentrations to get the

25  equivalent response.  But I do believe that there is a

Page 180

1  first draft of the actual document and the second

2  draft.  So, we should be seeing this document two more

3  times, and - -

4	MR. RICHMOND: Just to clarify, no, you

5  won't be seeing this document.  You'll be seeing a

6  draft exposure risk assessment report.

7	DR. HENDERSON: Oh, okay.

8	MR. RICHMOND: I mean, there's a huge

9  difference.  This was the road map, this plan.  We

10  don't, we plan to take into account your comments and

11  the comments of the public in figuring out what we

12  ultimately do.  But the revised methods and what we

13  actually do will be in, along with the results, in the

14  first draft risk assessment, that's targeted for March.

15	DR. HENDERSON: Your report.  Okay,

16  that's good, and I'm glad you - -

17	MR. RICHMOND: I just want to make sure

18  they do, and on the scheduling and we don't, under the

19  new process, we don't produce a final of this plan.

20	DR. HENDERSON: Oh, no.

21	MR. RICHMOND: The plan is a living - -

22	DR. HENDERSON: No, no, no, no.  I'm

23  just, but this is leading to a document that will be

24  reviewed two more times.

25	MR. RICHMOND: Right.

Page 179

1  tolerance that is developed with persistent exposure to

2  NO2.

3	DR. HENDERSON: And that's very hard to

4  take into account at setting any standard, I'm sure,

5  but.  Well, okay, I think we, now.  I will do as Ed did

6  earlier.  Anything, any advice or that you were

7  expecting to get that you haven't gotten and would like

8  for us to comment while you have this great group of

9  investigators here?

10	DR. GRAHAM: After your other comment, I

11  did have a question specifics about, we had selected, I

12  think, five locations, and I briefly said there were

13  criteria in their selection.  And, I think it was Ed

14  had commented, why not Phoenix and Denver, and I was

15  just wondering, why those might want to be included?

16	DR. AVOL: I picked those two in looking

17  at previous annual standards in violations of the

18  standards, and just thinking about distribution and

19  representation of the national picture that Phoenix and

20  Denver offered other sorts of geography and exposure

21  issues than just the urbanized cities like New York and

22  Philadelphia, sort of thing.

23	DR. HENDERSON: Any more advice for the

24  Agency.  We will be seeing this again, of course, but

25  the consultation comes first, and then there's the

Page 181

1	DR. HENDERSON: But thank you for

2  correcting.  This has gotten so complicated with the

3  new process, but it's good to be precise, so I'm glad

4  you corrected that.  And, perhaps, we can - -

5	DR. MARTIN: If I might, perhaps, it

6  might be worth saying, just a little bit of

7  clarification about what you can expect to see in the

8  first draft - -

9	DR. HENDERSON: Good.

10	DR. MARTIN: - - of the risk assessment

11  report versus what you can expect to see in the second

12  draft of the risk assessment report.  And I'll just

13  layout an initial major distinction, and you folks can

14  add to it as you will.  We talked about estimating

15  exposures and risks associated with various alternative

16  standards.

17	And first of all, looking at just air

18  quality,  current levels of air quality, and then, just

19  attaining the current standard.  Those are the

20  scenarios that we anticipate putting into the first

21  draft of the risk report, and that you will be seeing

22  those results and estimates associated with those two

23  scenarios in the Spring, at the same time you see the

24  second draft integrated science assessment.

25	Subsequent to that, in the second draft, we

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Page 182

1  would then, at that point, decide what alternative

2  standards we would then, additionally, do exposure and

3  risk estimates for.  Because at that point, we would

4  have the benefit of the second draft science

5  assessment, and the benefit of your review of that

6  document, to help inform an appropriate range of

7  alternative standards that would reasonably be applied

8  to finish out the exposure and risk assessment.

9	So, those results you'll see in the second

10  draft assessment.

11	DR. HENDERSON: Okay, that's helpful.

12	DR. MARTIN: And I wanted to make that

13  point, because in the past, when we've come out with

14  the first draft assessment, what everyone's looking for

15  is, what is the risk associated with the range of

16  alternative standards, and that, that's what we'll do

17  in the second draft.

18	DR. HENDERSON: Second draft, in the

19  first draft, you'll have the risks associated with the

20  current exposures and the, if you reach the higher

21  levels of the - -

22	DR. MARTIN: And it relates to the

23  comment I made yesterday.  We really don't want to get

24  ahead of ourselves.  We don't want to start projecting

25  to what alternative standards may be appropriate to

Page 184

1  until I guess receive sort of the next step.  So, as a

2  starting point, I think it was fine.  And then, I think

3  we'll have to see what comes.

4	DR. HENDERSON: Okay, John.  Yeah, and

5  we've had a very good clarification of what the next

6  steps will be.  Did you get to hear that?

7	DR. BALMES: Yeah, I did hear that.  I

8  heard that, yeah.

9	DR. HENDERSON: Okay, so that was very

10  informative.  And, okay, John.  Well, we hope you

11  didn't rush over to, we were just waiting for you to,

12  in order to adjourn, to tell you the truth.

13	DR. BALMES: Oh, okay, well, then.  I'm

14  sorry to hold anybody up from adjourning.

15	DR. HENDERSON: Well, we've had

16  interesting discussions.  Really, this last discussion

17  was most helpful, and we wouldn't have had it if we

18  hadn't have been kind of waiting for you.

19	DR. BALMES: Oh, okay, okay.

20	DR. HENDERSON: So you contributed.

21	DR. BALMES: I'll be in person next time.

22	DR. HENDERSON: Okay.  Thanks a lot,

23  John, for calling in.

24	DR. BALMES: Okay, bye.

25	DR. HENDERSON: Okay, I think we are

Page 183

1  consider until we've had the benefit of your review of

2  the second draft of the science assessment, where the

3  inferences and conclusions are more sharply defined.

4	DR. HENDERSON: Good advice, Karen.

5	DR. MARTIN: Did you offer anything.

6	SPEAKER: No, that's okay, well stated.

7	DR. HENDERSON: Good.

8	SPEAKER: Rogene, somebody may have

9  just - -

10	DR. HENDERSON: That's what I thought.

11  Is there someone that had come on the phone?

12	DR. BALMES: ;Yeah, this is John, hi.

13	DR. HENDERSON: Oh, you have no idea how

14  happy we are to hear from you, John.

15	DR. BALMES: Yeah, no, I just listened.

16	DR. HENDERSON: Okay, well, we would like

17  your comments on the risk assessment part of this

18  methods document.  And, I'll tell you that the response

19  before you has been generally positive.  You probably

20  didn't get to hear all that, but - -

21	DR. BALMES: No, I, you know, I'll tell

22  you, Rogene.  I don't, I didn't provide written

23  comments on it at this point.  I didn't have, I guess,

24  very much to say, because, in a sense, it was such a

25  general template that I didn't see too much to say

Page 185

1  finished in our, it is the job of our DFO to adjourn

2  us.

3	DR. NUGENT: Well, thank you all for

4  being here, and then the next steps will be for me to

5  send around a draft of the document we spoke about this

6  morning, and send a draft of the minutes around for

7  your comments.  And I guess, even before I do that,

8  I'll be contacting you about scheduling the May meeting

9  to get your availability, so, I look forward to seeing

10  you again and thank you.  Meeting's adjourned.

11  (WHEREUPON, the PUBLIC MEETING was adjourned at 1:45

12  p.m.)

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1	CAPTION	1

2	The foregoing matter was taken on the date,	2

3  and at the time and place set out on the Title page	3

4  hereof.	4

5	It was requested that the matter be taken by	5

6  the reporter and that the same be reduced to	6

7  typewritten form.	7

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8	Further, as relates to depositions, it was	9

9  agreed by and between counsel and the parties that	10

10  the reading and signing of the transcript, be and	11

11  the same is hereby waived.	12

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Page 187

1	CERTIFICATE OF REPORTER

2  COMMONWEALTH OF VIRGINIA

3  AT LARGE:

4	I do hereby certify that the witness in the

5  foregoing transcript was taken on the date, and at

6  the time and place set out on the Title page hereof

7  by me after first being duly sworn to testify the

8  truth, the whole truth, and nothing but the truth;

9  and that the said matter was recorded

10  stenographically and mechanically by me and then

11  reduced to typewritten form under my direction, and

12  constitutes a true record of the transcript as

13  taken, all to the best of my skill and ability.

14	I further certify that the inspection, reading

15  and signing of said deposition were waived by

16  counsel for the respective parties and by the

17  witness.

18	I certify that I am not a relative or employee

19  of either counsel, and that I am in no way

20  interested financially, directly or indirectly, in

21  this action.

22

23

24  MARK REIF, COURT REPORTER / NOTARY

25  SUBMITTED ON OCTOBER 25, 2007

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20

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129:11 133:12

152:1 156:1 160:15

cases 15:1 32:1

48:24 122:1

categories 61:13

category 134:1, 1,

11

causal 42:22 61:21

62:1, 19, 21,

22, 25 112:21

158:1 177:15,

24, 24

causality 112:23

145:15 177:14

cause 16:19 23:14

44:1 46:18 47:1

50:1 52:1 65:10

73:1 110:1 124:1

125:10 126:14

129:1, 19 138:16

139:25 146:17

172:23

caused 108:21

causes 46:1

causing 30:15 caution 9:11 113:1 cd 35:11, 17

census 98:22

central 20:14, 25

21:1, 14, 22 22:13

27:1 49:16 121:1

certain 47:1, 24

115:17

certainly 10:21

34:17 36:25 44:1

46:13 48:1 54:1

68:1 74:23

105:22 115:12

116:14, 16

134:10 146:1

cetera 10:25 24:16

42:19 47:1 67:12

111:13 114:23

137:1

chain 176:11

challenge 101:1

115:23 140:12

148:10 166:1, 1

challenged 43:18

challenging 115:1

129:25 134:25

chambers 173:1, 1

chance 6:1, 25 7:1

175:20, 23

change 25:1 28:20

29:21, 24 36:17

48:22, 25 55:10

58:13 72:22 105:12

138:11 158:20

161:18 173:18

176:23

changed 45:1 46:18

60:12

changes 49:1, 13, 20

50:1 59:1 73:10

123:23 165:1

changing 164:11

174:16

chapter 16:20

35:16 41:25

61:19 67:24

68:1, 18, 19, 24

69:1, 12, 18, 25

70:1, 1, 1, 22

71:1, 1 72:1, 1,

1, 1

chapters 68:10

69:1 70:1, 1, 10

71:1

characterization

95:19 96:1

105:16 174:23

characterizations

174:10, 11

characterize 34:1

84:1 101:1

146:20 174:25

175:10

characterizing 84:17

charge 6:23, 25 7:18

19:14 34:18, 20,

21, 24 39:1

61:15 64:10 106:1,

1 109:1

charlotte 133:12

charter 78:16 chartered 78:14 chattanooga 90:1 chemical 44:1 93:24 chicago 96:23

113:15, 16, 18

114:19

childhood 165:1

children 49:1, 13,

14 63:24 64:25

65:1 102:14 104:23

163:1 173:1, 1

children's 46:10

52:1 64:24 75:24

156:1 164:24

170:20

chime 136:22

choice 109:14 110:1,

1 131:1

choices 102:17

130:24 149:15

160:14

choose 35:14, 23

110:1 175:1

chooses 35:21

choosing 157:24

161:1

christian 127:1

chronic 47:11 164:23 chug 138:10 circumstances 56:16 cite 17:11 44:14 cited 115:13

cities 13:16, 19

14:10 110:1, 1

115:14 116:20

118:21 119:1

120:1, 1, 14 130:1

163:11 179:21

city 15:23 117:14,

25 163:11

clarification 9:21

10:1 23:1 31:1

60:1 170:16

181:1 184:1

clarified 77:17

clarifies 80:1 113:1

clarify 38:13 117:10

127:17 134:1 150:1

159:13 180:1

clarifying 116:25

classes 128:1 clean 2:1 87:19 clear 20:12 36:1

65:14 66:23

86:24 90:19

111:17, 17

132:14 135:19

139:1

clearer 136:1

clearly 22:1, 10

36:1 58:23 71:11

83:12 84:14

85:1, 1 122:24

123:1 142:22

157:20 160:21

177:24

clicker 95:1

clinical 21:1, 11

22:1 33:1 57:20

91:20 92:10 111:12

112:19 113:1

138:14 139:1 146:1

170:21, 24

171:17 175:12

clinically 173:1

close 13:1 49:17

54:18 57:23 63:1

109:1 133:1

closely 157:1

closer 54:13

clue 146:1

cmsa 150:12, 13

co 33:1 67:1

126:17 153:11

co-pollutants 39:24,

25

coal-fired 133:14

coefficients 29:10

coherence 39:1 45:17

50:18, 20 51:10

53:10

coherencies 53:22

coherent 43:19 53:1

cohort 113:17 cohort-based 98:19 collection 74:19

85:20

com 12:18

combination 84:11

139:17 172:20

combine 69:1

combined 175:19

combining 101:22

140:12

combustion 44:21

45:11 51:21 52:1

comes 42:20, 23

78:18 79:13

118:1 149:20

179:25 184:1

comfortable 3:1

50:19 67:1, 16

78:1, 12, 15

comforted 138:12

coming 39:13 47:19

67:1 78:13 81:1

87:21 123:10

132:25 137:1

157:1, 1 167:22

comma 52:22

comment 3:21 4:22

22:1 40:12, 13

74:1 120:17 121:19

124:20 129:18

134:17 135:1 136:1

140:1 142:1, 17,

18 143:10 144:1,

12, 20 156:1,

14, 14 157:17

158:1 159:1

168:20, 23 173:13,

16 179:1, 10

182:23

commented 81:16

179:14

comments 4:1, 10, 15

5:1, 1, 14, 17, 20

24:1 33:19 37:23

38:1, 1 39:1

40:1 71:1, 13,

21 81:1, 1, 15

84:1, 24 108:14

109:1 110:24

116:1, 10, 11

128:22 130:24

131:13 132:12

136:16, 20 137:1

138:1 140:1

142:11, 11, 15

144:1 147:1, 20

152:1 153:24

155:1, 1, 16

156:15 157:15

159:14 163:15,

22 165:20, 21

167:1 169:16,

16, 18 170:1, 1,

10, 11 180:10,

11 183:17, 23

185:1

committee 2:1 3:1

65:15 87:20

115:16, 25

130:25 149:1

committees 77:24

communities 49:14 community 166:1 commuting 111:24 comparability 27:19 comparable 16:1 21:1

27:14

compare 2:21 11:22

12:19 20:1 27:1,

15 33:23 48:17

74:19 100:16

117:19 171:1

compared 2:18

15:25 99:1

101:17 102:1

112:15 117:18

comparing 22:1 112:1

comparison 48:12, 14

97:11 122:1, 10,

20 124:12 126:15

comparisons 99:1

compartment

167:23, 23

compatible 175:24

compilation 2:16, 17

3:1 70:1

compile 33:22

complete 3:16 5:1

77:1 78:1 82:1

completed 103:1

116:11

completely 29:21

76:20 136:1

complex 135:18

complexity 134:24

compliance 151:21

152:17

complicated 113:22

114:11 181:1

compliment 125:1

comply 87:1 component 12:12 components 58:13

61:1 86:1

composition 93:25

comprehensive 96:21 con 92:19 145:18 concentration 12:22,