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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 (CASAC) LEAD REVIEW PANEL

 + + + + +

 PUBLIC MEETING

 + + + + +

 WEDNESDAY, APRIL 11, 2012

 The committee met in Salon B of

the Marriott at Research Triangle Park, 4700

Guardian Drive, Durham, North Carolina, at

8:30 a.m., Dr. H. Christopher Frey, Chairman,

presiding.

PRESENT:

DR. H. CHRISTOPHER FREY, Chair

MR. GEORGE A. ALLEN

DR. HERBERT ALLEN

DR. RICHARD CANFIELD

DR. DEBORAH CORY-SLECHTA

DR. CLIFF DAVIDSON

DR. PHILIP E. GOODRUM

DR. SEAN HAYS*

DR. PHILIP HOPKE

DR. CHRIS JOHNSON

DR. SUSAN KORRICK

DR. MICHAEL KOSNETT

DR. ROMAN LANNO

DR. DEIRDRE MURPHY

MR. RICHARD L. POIROT

DR. JOEL G. POUNDS

DR. MICHAEL RABINOWITZ

DR. WILLIAM STUBBLEFIELD

DR. IAN VON LINDERN

DR. GAIL WASSERMAN

DR. MICHAEL WEITZMAN*

MR. AARON YEOW, DFO*

MR. EDWARD HANLON, Acting DFO

DR. VANESSA VU, Director, SAB Staff Office

*Via telephone
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 C-O-N-T-E-N-T-S

EPA Presentation on Risk and Exposure

 Information and Considerations

 in the Policy Assessment. . . . . . . . .7

Discussion of Key Points. . . . . . . . . . . 73

Adjournment . . . . . . . . . . . . . . . . .165

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

2 (8:32 a.m.)

3 MR. HANLON: We are going to begin

4 the meeting now. And just a quick point for

5 everyone at the meeting today. We have draft

6 key points for discussion this morning, and we

7 have hard copies for members and also for the

8 public on the table outside. We'll be showing

9 them on the screen today. In the next several

10 days, these summary points that are going to

11 be shown in the meeting today will be posted

12 on our meeting website. Chris? 

13 DR. FREY: Okay. Good morning. I

14 want to thank everyone for being here on time,

15 and we're going to get started. Just to

16 review the agenda for today, we have a

17 presentation from EPA on information and

18 considerations regarding the risk and exposure

19 assessment that will be part of the policy

20 assessment. And then we will have a time

21 period after that to provide an opportunity if

22 any members of the public have any clarifying

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1 questions. 

2 Followed by that, we will discuss

3 key points. And what we might do, since we'll

4 have just recently heard about the REA, is

5 maybe we'll start with that since that will be

6 fresh in our memories. As we get later into

7 the morning, what I would like to do is circle

8 back to issues that we talked about yesterday

9 and, in particular, to see where we are on the

10 response to the charge questions. So we'll

11 review that. The goal is not to do a lot of

12 wordsmithing or editing but just at a

13 conceptual level to see if we're on track to

14 complete those responses. 

15 And just something to be thinking

16 about is we do want to make sure we answer the

17 charge questions that are posed, which doesn't

18 mean that we can't go beyond that if we see

19 something significant that we want to say. 

20 But we should, at a minimum, be responsive to

21 the charge questions. And I realize, you

22 know, this is a first draft of the response to

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1 charge questions, and I think there will be

2 some need to iterate to make sure that we are

3 addressing the charge questions. And we can

4 discuss that as we go through. And also if we

5 have any reflections on what we heard

6 yesterday regarding monitoring or aviation

7 gasoline, we could spend a few minutes

8 discussing those. 

9 Just to get a sense, we're

10 scheduled to adjourn at 12:30. Is there

11 anyone who needs to leave before 12:30? Okay. 

12 So we have most of the panel then. So I think

13 we can presume we'll go to 12:30. We won't go

14 past 12:30. If we need it, we'll go to 12:30.

15 Okay. So any clarifications

16 either from the DFO or staff or panelists? If

17 anyone, a member of the public would like to

18 offer clarifying questions, if you're in the

19 room, it would be good if you'd let Ed Hanlon

20 know that. If you're on the telephone, I

21 guess we'll poll you for that when we get to

22 that part in the agenda.
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1 Okay. With that, I would like to

2 turn the floor over to Dr. Zach Pekar and Dr.

3 Deirdre Murphy, and we look forward to your

4 presentation. Thank you. 

5 DR. MURPHY: Thank you very much. 

6 We appreciate the opportunity to take a few

7 minutes to talk to the panel this morning. As

8 you recall from your consideration last summer

9 of the REA planning document, our review of

10 the information newly available in this review

11 concluded that that information did not

12 warrant development of a completely new risk

13 and exposure assessment. So this morning

14 we'll take a few minutes to discuss the risk

15 and exposure assessment developed for the

16 review completed in 2008 and how we'll be

17 considering the information from that

18 assessment in the policy assessment for this

19 review, and a draft of that policy assessment

20 will be the topic of discussion by this panel

21 in the next face-to-face meeting scheduled for

22 sometime this fall.

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1 So with that, I'll turn it over to

2 Dr. Zach Pekar. 

3 DR. PEKAR: Okay. So let me just

4 make sure I'm getting this right. That's what

5 the coffee is for. Okay. So just

6 presentation objectives. Obviously, the risk

7 assessment that was completed in 2008 is a

8 pretty complicated analysis. And as we go

9 through some of the details of it, I'm going

10 to sort of move, I think, fairly quickly and

11 try not to get bogged down in details, sort of

12 a similar comment to last time.

13 But the goal of the presentation

14 today is to really talk about some of the

15 background to frame the way we're going to

16 present the 2008 risk results in the context

17 of the current policy, the current review. 

18 And we're going to, for the presentation

19 today, I'm going to provide a little

20 background for the risk assessment itself,

21 going over some of the elements of the risk

22 assessment, and then discuss the way in which

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1 the evidence published since the last risk

2 assessment, the 2008 risk assessment, will be

3 used, the degree to which it will be

4 considered in helping us to interpret those

5 risk estimates and get an additional sort of

6 refined understanding and characterization of

7 uncertainty and confidence associated with

8 those risk estimates.

9 So just a little background on

10 lead air pollution in the context of the risk

11 assessment that was completed. I think most

12 of these points will be, I think, generally

13 known by most of you. But lead occurs,

14 obviously, naturally and is emitted by many

15 anthropogenic sources. The highest levels

16 that we currently experience are generally

17 near lead smelters. Lead is emitted into the

18 air primarily in particulate form, and then it

19 can be deposited to a number of sources, and

20 that's important for us. Some of those

21 deposited, the deposition of surfaces result

22 in some of the highest exposure pathways in

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1 terms of risk related to ambient air.

2 People exposed obviously directly,

3 if we're talking about lead in ambient air,

4 directly through inhalation, but they're also

5 importantly exposed through the ingestion of

6 soil that's been deposited to surfaces,

7 whether that's outdoor soil and, importantly,

8 in the context of the risk assessment that was

9 completed, indoor residential surfaces. 

10 You'll have lead that penetrates indoors and

11 it's deposited, and then it's ingested.

12 Children are more highly exposed

13 than adults, generally speaking, in the

14 residential setting because of the higher

15 hand-to-mouth activity that children

16 experience and, because ambient air lead can

17 penetrate indoors and deposit to surfaces or

18 deposit outdoors to soil, you're going to have

19 relatively higher exposures for children. 

20 Once in the body, lead can be absorbed fairly

21 readily into the bloodstream.

22 And lead is also persistent. When
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1 we looked at designing the risk assessment and

2 completing it, we had to deal with the fact

3 that more recently released ambient air lead

4 could cause exposures, but also children could

5 be exposed to lead that had been released many

6 years ago or used even many years ago, for

7 instance through indoor paint exposure or

8 mobilization of older anthropogenic lead that

9 may have been released through autoemissions

10 in the past and becomes part of the even

11 current ambient air signal. 

12 So this figure goes through the

13 ambient air-related exposure pathways, and

14 there are a number of different pathways and

15 really sort of helps us to frame the risk

16 assessment that was completed. So beginning

17 with the top of this diagram, you see that we

18 have lead in ambient air. If we start on the

19 left-hand side, we see, obviously, we have

20 direct inhalation of ambient air, lead in

21 ambient air. You also, as I mentioned, have

22 the penetration of ambient air indoors with

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1 deposition to indoor surfaces and subsequent

2 dust, indoor dust ingestion. That's the

3 second sort of pathway there. And then on the

4 right-hand side with the unshaded boxes, and

5 I'll explain that shading in a second, you

6 have deposition to outdoor surfaces: outdoor

7 soil; even contamination potentially of food

8 crops through either leaf deposition or

9 deposition of soil and potential uptake; and

10 then drinking water contamination,

11 particularly if you have reservoirs or other

12 sort of surface water sources that are used

13 for drinking.

14 So this is sort of the range of

15 pathways that are considered. And in the risk

16 assessment, we did include all these pathways

17 in our modeling. But just to sort of go back

18 and review that for a second, when we looked

19 at an alternate lower standard level, sort of

20 dialing down the ambient air lead, the

21 pathways that were actually modeled for

22 response in terms of exposure and risk are

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1 highlighted here with the gray shading. And

2 so you see, obviously inhalation would

3 decrease because you'd have a reduction in

4 ambient air lead that would be simulated. But

5 very importantly, the indoor dust ingestion

6 pathway was simulated to change, and there was

7 a lot of effort to really integrate or

8 complete that part of the analysis.

9 The non-shaded boxes on the right10 hand side, although we modeled risk, we didn't

11 reflect reduction in ambient air in terms of

12 a reduction in those pathways. We held those

13 pathways constant, mainly because challenges

14 in completing that part of the analysis, some

15 technical challenges.

16 The green sort of central little

17 oval there is just to really emphasize the

18 point that historically released lead did play

19 an important role in driving various pathways,

20 or contributing to various pathways I should

21 say here. In certain instances, it may not be

22 possible to really tease out the fraction of

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1 that, but it could be an important role. For

2 instance, we did have, obviously,

3 contributions from older paint and older

4 houses within some of the residential areas

5 contributing to the dust, indoor dust

6 exposures, along with ambient air. Yes? 

7 DR. KOSNETT: Zach, is the gray

8 then like what they call recent lead? 

9 DR. PEKAR: Yes. Yes, that's a

10 really good point. So we had the recent air

11 lead, the past air lead, and then we had sort

12 of a background exposure signal also. 

13 And this is actually a good point

14 for me to raise another point that I wanted to

15 make. I think we discussed this yesterday to

16 a certain extent, and I just wanted to

17 reiterate this point. Inhalation alone is a

18 relatively insignificant, I mean, depending on

19 how you look at it, but a relatively small

20 component of overall exposure and risk. And

21 so the modeling that we conducted suggested

22 that direct inhalation usually contributed
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1 something in the range of 0.5 to 0.6 percent,

2 so less than one percent of total exposure and

3 risk in the residential scenarios that we

4 looked at.

5 What was important is the central,

6 the indoor ingestion of dust driven directly

7 by ambient air, so the ambient air portion of

8 indoor dust exposure ranged from 12 to 28

9 percent of total exposure. So the point here

10 is that what we found is that ambient air

11 could represent up to a third or more of total

12 exposure and risk, but the majority of that

13 was driven by indoor dust ingestion with

14 loading from ambient outdoor air. And there

15 are a lot of other nuances that we'll frame

16 and obviously talk about in terms of the

17 potential that we may have underestimated

18 certain ambient air impacts in the right-hand

19 boxes since we didn't look at those. So we

20 may have actually underestimated total ambient

21 air contributions because, obviously, there

22 would be some contributions to soil that we

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1 didn't explicitly look at. Yes? 

2 DR. GOODRUM: In your model

3 simulations, did you vary that assumption

4 about the mass contribution of soil to indoor

5 dust, or did you just hold that fixated

6 constant --

7 DR. PEKAR: So there was an

8 intercept term. There were several different

9 dust models that I'll briefly mention in a

10 second. But, no, we didn't do that. We had

11 a fixed, generally, conceptually, a fixed

12 contribution, but there were non-linearities

13 in going from dust loading to concentration,

14 and so the regression equations would be used

15 for that. That could reflect a number of

16 factors that we talked about in detail at that

17 point, and we'll probably discuss some of

18 those in framing the presentation of risk

19 results in this review.

20 Okay. So now, in terms of looking

21 at the estimation of air-related exposure and

22 risk, and touching on some of the key points

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1 here. So, obviously, our objective was to

2 evaluate or estimate IQ loss in children. 

3 That was the end point that we were looking

4 at, and to relate changes in ambient air

5 levels of lead or an absolute degree of

6 ambient air lead to a degree of IQ loss. 

7 That's sort of the goal of the analysis. And

8 we don't have epidemiology studies that

9 directly link ambient air lead to IQ loss. 

10 You know, it's usually some kind of biometric. 

11 It's blood lead, it's bone lead. And so the

12 risk assessment really needed to go from

13 ambient air lead to the biometric, in our

14 case, blood lead various concurrent lifetime

15 average metrics that we're using and then

16 translate that with the concentration/response

17 function from epi studies into IQ loss. 

18 Probably most of you are clear on that point.

19 I think the point we wanted to

20 make here is, importantly, there's some non21 linearities in characterizing both the

22 exposure to lead and also the response, the IQ

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1 loss. And those non-linearities, illustrated

2 here with this little diagram, meant that we

3 had to look at total exposure. We couldn't

4 just look at the air-related exposure and talk

5 about that because where a child is on the

6 distribution of lead exposure can have an

7 effect on the magnitude of an incremental

8 change in blood lead on IQ loss. 

9 And let me just make the point

10 with this graphic. If a child is closer to

11 ten where the triangle is there, an

12 incremental one unit change in blood lead will

13 have a smaller degree of IQ change, could

14 still be policy-significant, than you would

15 have if the child is at the circle where you

16 have a, potentially a steeper slope, based on

17 our epidemiology evidence. And because we

18 needed to be able to fix children on this

19 total blood lead curve, that meant that we

20 really had to look at total exposure which

21 introduced a lot of complexities into the

22 analysis that we've talked about and we will
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1 talk about when we're framing the risk

2 assessment. So the non-linearities and the

3 need to look at total exposure through all

4 pathways is an important detail.

5 So the approach that we used in

6 completing the risk assessment was a

7 multimedia case study approach. It's

8 multimedia and multi-pathway because we needed

9 to look at total exposure, so we needed to

10 consider all pathways, as I just mentioned,

11 and because ambient air exposure exerts itself

12 through both inhalation, as I mentioned, and

13 indoor dust and other pathways. 

14 We completed a probabilistic

15 population assessment for each case study

16 location because we weren't simply interested

17 in the central tendency best estimate child

18 that we could generate with an IEUBK

19 simulation of pathways at their average

20 levels. We also wanted to try to characterize

21 higher end exposure and risk, which that's

22 important, I think, in terms of looking at

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1 more highly air-exposed children, but it also

2 introduced additional challenges, for

3 instance, how correlated are pathway exposures

4 at the high end? Do you have a child that you

5 simulate to have 15 micrograms per deciliter,

6 what's the contribution from air versus other

7 pathways? And the information on that kind of

8 correlation across exposure ranges is not, we

9 don't have a lot of information on that

10 pathway correlation, so that's another

11 challenge.

12 In terms of the populations that

13 we modeled, the case studies, I guess you can

14 look at the case studies in terms of the types

15 of populations that were modeled, second

16 bullet here. And we had, on the one hand,

17 more highly exposed populations that we

18 simulated. We had a general urban case study

19 which assumed that you had sort of a

20 neighborhood of children at a fixed level of

21 exposure near the standard level you're

22 looking at, so that's really looking at what

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1 risks they would have if you had a group of

2 kids at that exposure level.

3 The primary lead smelter case

4 study also focused on more highly exposed

5 children because we looked at a two-kilometer

6 radius right closest to the facility in terms

7 of really focusing our analysis, and those

8 kids were exposed pretty close to the current

9 standard with some gradient but not a lot of

10 spatial gradient. That happened further from

11 the facility. 

12 We looked at a broader

13 distribution of exposures by looking at the

14 urban case studies, which included Chicago,

15 St. Louis, and L.A. And those case studies

16 looked at a wider distribution. 

17 DR. MURPHY: Cleveland. 

18 DR. PEKAR: Cleveland. Yes,

19 Cleveland. Sorry. And those scenarios looked

20 at a greater variation in the spatial

21 distribution of ambient lead exposure, so you

22 had some kids who were exposed at higher

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1 levels but a lot of children that weren't

2 trying to get a more representative picture of

3 a larger urban exposure scenario.

4 So this diagram illustrates these

5 three categories of case studies, the general

6 urban case study on the left being a uniform,

7 basically sort of a group of children exposed

8 at a uniform level, at the standard level. The

9 primary lead smelter, as I explained, having

10 a two kilometer radius immediately near the

11 facility; and then the location-specific urban

12 case studies looking at actual cities with a

13 wider spatial gradient in exposures. 

14 DR. KOSNETT: In your case studies

15 where it says, you know, look at large urban

16 areas with varying demographics, do you take

17 into consideration that some of the areas that

18 are near these point sources may have higher

19 background levels of lead because they may

20 represent, for example, children with other

21 risk factors for higher lead exposure, like

22 older housing? They also may be more
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1 vulnerable because they may have lower income

2 and be more iron-deficient or things like

3 that. I mean, it's a complicated approach,

4 but are you modeling that at all or

5 considering that? 

6 DR. PEKAR: Well, so very, I

7 guess, briefly, and we can certainly talk

8 more, you know, if you want to about this. A

9 number of those factors, it's difficult to

10 quantitatively reflect those. I mean, if you

11 have a dietary deficiency, you have greater

12 potential uptake. We don't have necessarily,

13 with an IEUBK, for instance, the ability to

14 simulate some of these greater enhanced sort

15 of factors that can increase biometric levels,

16 I would say, like blood level values.

17 The short answer is the GSD that

18 we use, the geometric standard deviation,

19 giving you the spread of exposures around a

20 central tendency estimate would reflect some

21 of that variability to some extent. We used

22 a regionally, nationally representative indoor

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1 dust lead value that reflected indoor paint

2 along with our modeling of air. There's some

3 complexity there that I can get into on the

4 side, if you want to talk about this. 

5 One thing to keep in mind is,

6 because of the non-linear response of IQ loss,

7 ironically, if you push children higher

8 because of their background paint exposure,

9 then the relative impact of air actually

10 becomes lower. So what we were really

11 interested in is the situation we had very

12 highly air-exposed kids without a lot of non13 air signal, so they're in the more potent

14 portion of the exposure range but because of

15 air. That ameliorated, to a certain extent,

16 our need to fully characterize and capture

17 kids that may have high paint. We were really

18 focusing on high air, but there's some nuances

19 there that we can talk about. It took us a

20 while to figure that out, too.

21 So a lot of complexity that I

22 think has come out in some of these questions

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1 of the risk assessment -- and I don't want to

2 take a lot of time here because I can go on

3 about this analysis. So in terms of

4 characterizing various media concentrations,

5 there were different approaches and data sets

6 used in the different case studies. For

7 ambient air lead, we had ambient monitoring

8 data for the actual cities that we modeled. 

9 We had monitored levels, and that gave us a

10 crude spatial gradient that we can incorporate

11 into our modeling. 

12 For the primary lead smelter, we

13 used air dispersion modeling, again to get a

14 spatial gradient. Because we focused on a

15 very tight area around the facility, we were

16 at a fairly high level of the plume before you

17 started to see greater dropoff in

18 concentrations. That being a relative term,

19 obviously, around a primary lead smelter. 

20 Then for the general urban case

21 study, we were again fixing the ambient level

22 at whatever standard we were looking at, so

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1 there was no modeling. We were just assuming

2 a set level. 

3 For indoor dust lead, there was a

4 lot of complexity in this. For the urban

5 residential case studies, which is the general

6 urban case study in the city-specific case

7 studies, we generated a fairly sophisticated,

8 developed a fairly sophisticated model that

9 combined compartmental elements and empirical

10 elements, deterministic mechanistic modeling

11 and some empirical data to sort of get at this

12 issue. 

13 For the primary lead smelter,

14 because we had a lot of monitoring data across

15 various media, we generated just a regression

16 statistical model for relating outdoor air to

17 indoor dust. And then in terms of outdoor

18 soil, and I mentioned this a little bit

19 already, we used a national sort of regional

20 data set to get us a central tendency estimate

21 for urban soil for the urban settings. And

22 then the primary lead smelter had a lot of
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1 data on soil that we used and the risk

2 assessment measure data, site-specific data.

3 So because of the complexity of

4 the analysis, if you look at the risk

5 estimates, those of you who are familiar with

6 this, there's a lot of dimensions and some

7 ranges that are presented. It's not one

8 estimate reflecting these different sort of

9 elements and dimensions of the analysis, and

10 that would be reflected in our presentation of

11 the risk estimates. We had, as I think we

12 mentioned already, several different

13 characterizations of the ambient air impact. 

14 We had sort of the recent media concentrations

15 and recent ambient air impacts, sort of

16 inhalation and indoor dust which were directly

17 linked to ambient air. Then we had soil,

18 other concentrations that, while related to

19 ambient air, we weren't actually tweaking or

20 adjusting. And then we had pathways that were

21 less susceptible to impact by sort of

22 proximate ambient air. So if you're talking

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1 about dietary exposure, clearly diet and food

2 could be impacted, but the ambient air around

3 you is probably not what's impacting your

4 diet. Unless you're growing your own food,

5 you're probably getting it from other places. 

6 So we had several of these different

7 categories of risk that we would look at that

8 gave us a range all the way from total risk

9 across all pathways to just looking at the

10 inhalation of indoor dust linked to ambient

11 air, for instance.

12 And then there are other

13 dimensions, too. There were multiple dust

14 models used, as I mentioned. And we also

15 looked at several different concentration

16 response functions that handled the IQ loss at

17 lower exposure levels in different ways. So

18 we tried to reflect uncertainty, 

19 characterization of uncertainty in that

20 important element of the risk assessment, too. 

21 And these all sort of resulted in a

22 multidimensional characterization of risk for

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1 each case study. We also looked at different

2 percentiles of the population.

3 So I have a hard time looking at

4 that, which means it was probably too small. 

5 So one thing we're also going to do,

6 obviously, is look at how information

7 presented or published since the risk

8 assessment can be used in helping us to

9 further sort of refine our understanding and

10 characterization of uncertainty and confidence

11 in the risk estimate. That's going to be an

12 important part of presenting the risk

13 estimates in the policy assessment. And what

14 we've done is we've looked at the critical

15 modeling elements of the risk assessment in

16 which we had significant uncertainty as framed

17 and discussed in presenting the risk

18 assessments in the past, and we asked

19 ourselves, you know, if we look at each one of

20 these elements and look at information that's

21 been published relevant to that element, do we

22 think that that information, the new

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1 information is going to help us to further

2 understand uncertainty, potential bias, and so

3 forth in this particular aspect of the risk

4 assessment? And this table sort of frames

5 that assessment, that analysis that we've done

6 of the new information, and I can quickly go

7 through this. It's mainly just to identify

8 for you areas where we think we're going to be

9 speaking to refining or improving our

10 understanding of the risk assessment using the

11 new information.

12 So beginning with ambient air, we

13 really, in our ability to characterize the

14 spatial gradient that residents may be exposed

15 to, we really don't think we're going to be in

16 a better position to do that, in a

17 demonstrably better position. But I also

18 don't think that there's significant

19 uncertainty there. One of the things to focus

20 on is that the general urban case study was

21 what we ended up putting a lot of emphasis on,

22 and that's sort of saying what happens if kids
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1 are exposed at the standard level we're

2 looking at, and that's a really important

3 question. And that sort of then doesn't

4 depend on characterizing a gradient. You're

5 really look at some set of kids exposed at

6 that level, so that's an important point to

7 make.

8 So we do have new information,

9 obviously, on soil and drinking water levels

10 for lead, but what we don't really have is

11 better information on the correlation between

12 those pathways and air-related pathways,

13 particularly at higher levels of exposure. 

14 And that, again, is really important. If we

15 characterize more highly air-exposed children,

16 to really have a better understanding, we want

17 to understand how those are correlated. 

18 Having said that, we do believe

19 that the additional air and water data, I mean

20 soil and water data, will help us to look at,

21 help us characterize potential uncertainty in

22 characterizing those media concentrations in

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1 the risk assessment and looking at whether,

2 you know, changes in those levels or better

3 information that's now available helps us to

4 look at potential shifts in those pathway5 specific risk estimates that could happen,

6 potential bias in those risk assessments.

7 Simulating indoor dust lead and

8 linked to ambient air, as I mentioned, this is

9 a really important aspect of the risk

10 assessment. There's a study by Hunt 2008 that

11 looked at Herculaneum and had some interesting

12 information on cleaning efficiencies and the

13 types of lead dust, the particle size of lead

14 dust that remains. Because that's very

15 specific to Herculaneum because it focuses on

16 a hard floor surface and doesn't include

17 consideration for carpeting, while it's

18 interesting and may help us to further look at

19 whether our cleaning efficiencies are

20 reasonable, whether there may be biases in

21 those, it doesn't really help us to refine the

22 residential scenarios in the general urban

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1 case study at all because of its focus on the

2 Herculaneum situation and because it didn't

3 consider carpeting. So I think it will be

4 useful in helping us to further understand

5 uncertainty, and we'll use it that way.

6 Pathway apportionment in lead

7 exposure. NHANES and NHEXAS had a number of

8 additional studies that have been published,

9 analyses that have been published looking at

10 pathway contributions. And I think this will,

11 again, help us to understand how our pathway

12 assessments for non-air pathways in particular

13 and dust are related to each other and the

14 degree to which sort of our assumptions or the

15 degree to which these may be correlated. 

16 However, because these don't really look at

17 ambient air lead, which they don't provide

18 coverage for that in general, we're not really

19 going to be able to use them to further refine

20 that aspect of the analysis. But it still may

21 help us with some of those other pathways that

22 were included in the risk assessment.

Page 33

1 And the next one has to do with

2 predicting population distributions of blood

3 lead levels. This is where we simulated a

4 central tendency blood lead value and risk

5 estimate and then we used the geometric

6 standard deviations to sort of characterize

7 the spread of risk around that. There is some

8 enhanced information on GSDs which will help

9 us to understand do we think, in some of

10 these, you know, do we think that the

11 distributions of blood leads around a central

12 tendency for residential population seem to be

13 getting smaller or are they getting wider, and

14 that will help us to understand some of the

15 bias. But, once again, it doesn't really help

16 us to get at the correlational information,

17 correlational issue of pathways which is so

18 critical to characterizing air-related

19 exposure and risk.

20 And, finally, in terms of IQ loss

21 modeling in children, our evaluation is that

22 we're not really in a position to have a
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Page 34

1 demonstrably different characterization of IQ

2 loss. But we think we'll certainly look at

3 those CR functions and see if it helps us to

4 gain any additional perspective, but I don't

5 necessarily expect a lot of refinement there.

6 So the final slide here is just to

7 sort of note and to provide an overview once

8 again of how we're going to present this

9 information. So, once again, we're going to

10 definitely present the risk information and

11 the policy assessment framing the analysis

12 that was done. We're going to look at the way

13 information has been published since the last

14 assessment to help us interpret and further

15 enhance our understanding of the risk

16 estimates and uncertainties, potential biases.

17 The degree to which any additional

18 situations, exposure situations that come up

19 between now and completion of the policy

20 assessment, if we identify any of those, we've

21 talked about airports and other things, we

22 certainly would look at using the case studies

Page 35

1 to help us get an understanding of those

2 exposure and risk situations. And then, you

3 know, we would obviously look at the public

4 health implications of the exposure and risk

5 information, including our enhanced

6 understanding of uncertainty that we would

7 gain by looking at how the evidence now helps

8 us to understand that. 

9 So thank you very much. 

10 DR. FREY: Yes, I would open it up

11 to some clarifications, but I wanted to ask a

12 couple of questions for clarification. So my

13 interpretation of what you've summarized is

14 that you don't see a need or a basis for

15 changing any of the structure of the exposure

16 and risk model, that there's inadequate

17 evidence to change the underlying equations or

18 algorithms in the model, and that there may be

19 some instances where more recent data are

20 available, maybe not directly relevant to

21 characterizing the transport across an

22 exposure pathway, for example, but maybe

Page 36

1 helping interpret uncertainties. 

2 I guess I was wondering if you

3 could clarify, though, is the proposal that

4 you're essentially implying here to do a

5 qualitative uncertainty assessment, or is

6 there a role for quantitative sensitivity

7 analysis or quantitative uncertainty analysis

8 related to some of the points in that last

9 slide? And related to that, could you comment

10 maybe a little more specifically on the

11 aviation gasoline exposure scenario and

12 whether or how that would really be addressed?

13 DR. PEKAR: Well, certainly, the

14 first one. I might let Deirdre handle the

15 second one. So, you know, we're still

16 continuing to evaluate the way the additional

17 information would be, in which instances it's

18 going to improve our characterization. I

19 mentioned some of these here. I expect that

20 to be primarily qualitative. I think there

21 may be some semi-quantitative, meaning, you

22 know, if you have a better characterization of

Page 37

1 soil levels and it looks like the mean soil

2 value, residential soil value is changed or it

3 might be different in different parts of the

4 country, it might speak to the fact that that

5 component of risk might be lower or higher,

6 which would impact the fraction of risk that's

7 air-related, but it's not going to impact the

8 air-related element. 

9 The point here is that I think you

10 could characterize, we do have additional

11 information now in some of the pathways, but

12 they're not air-related pathways, and that's

13 the critical element of the analysis, and we

14 would make that point. And, further, if you

15 can't really, if you don't have refined

16 information speaking to the correlation

17 between those pathways, particularly when air

18 exposures are higher, then we're really not in

19 a better position. So I would expect this to

20 be more of a qualitative, maybe semi21 quantitative characterization of changes in

22 those other non-air pathways where I think
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1 we're in a better position. 

2 In terms of the aviation, I think,

3 speaking sort of off the cuff a little bit on

4 this, I think we would look at whatever

5 ambient data we had. And, you know, you can

6 say, well, if you have ambient air levels and

7 you have different types of exposures, you can

8 look at what are risk assessments across a

9 range of risk estimates assignments have

10 characterized in terms of the risk associated

11 with that level of exposure. The general

12 urban case study I think being a good example

13 of that. 

14 So that's sort of my, you know,

15 these assessments help us to characterize

16 levels of exposure in ambient air levels, and

17 I would expect an airport scenario to be sort

18 of similar if we're talking about residential

19 exposures. If we're talking about non20 residential episodic exposures, then obviously

21 that's a different kind of situation because

22 that wasn't necessarily what we were looking

Page 39

1 at. 

2 DR. FREY: Okay. 

3 DR. MURPHY: Oh, sorry.

4 DR. FREY: Yes. Just a

5 clarification on what Zach mentioned. So when

6 you talk about the qualitative, is it fair to

7 assume that you would follow a structured

8 approach to that that's similar to what's been

9 done in other REAs in terms of something like

10 a modified WHO --

11 DR. PEKAR: Exactly. No, that's

12 exactly right. In fact, in the PM analysis we

13 started doing that, and it was very useful. 

14 So we would do that. That's exactly right.

15 DR. FREY: Yes, part of what I'm

16 trying to understand is what is the

17 methodological approach that you're planning -

18 -

19 DR. PEKAR: I think it would be a

20 systematic approach with each of these topical

21 areas with specific studies where we would

22 sort of say, you know, there's additional

Page 40

1 information here we think that suggests that

2 there could be a degree of bias, and then

3 implications from sort of an interpretation of

4 the air-related perspective would frame that.

5 Obviously, my take on this is that would be

6 sort of a no in those columns, but we would

7 speak to, you know, we do believe that this

8 shows that this particular pathway may have

9 changed. But in terms of overall air risk,

10 we're not in a position to have a different

11 characterization, particularly of high-end

12 risk for instance, something like that.

13 DR. FREY: Okay. And then I

14 think, Deirdre, you wanted to add something.

15 DR. MURPHY: I was just going to

16 add clarification. I know that you and Zach

17 speak on a particular wavelength, and I just

18 want to make sure people are tuned in. Just

19 one thing we consider in looking at this is

20 that we have a data set that's available from

21 the last risk assessment, and that's really

22 what we're going to be pulling in to this

Page 41

1 policy assessment. In the last staff paper,

2 we pulled in that data set which was brand

3 new. Now it's a little bit aged, but it's

4 still our data set that we base the primary

5 presentation on. And then it will be informed

6 by, as Zach just went through, our

7 understanding of the current situation and

8 evidence in the current situation.

9 DR. FREY: Okay. I know a number

10 of panelists wanted to ask questions. I think

11 Phil and -- okay. The order I'm aware of, I'm

12 going to say Phil, Chris, George, and Michael.

13 DR. GOODRUM: Okay. I'll try to

14 be quick.

15 DR. FREY: Okay.

16 DR. GOODRUM: Zach, can you speak

17 a little bit more about what the emphasis is

18 going to be on the risk characterization and

19 how you're qualitative or quantitative

20 uncertainty analysis will be presented,

21 especially if you're going to try to tease

22 out, for example, the gray box components, the
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1 recent air components, the uncertainty in that

2 part of your various simulations from all the

3 other uncertainties?

4 I'll maybe try to articulate why

5 I'm asking that question. So we've talked a

6 lot in previous panel meetings about two major

7 ways to present risk. One is to focus on the

8 absolute, you know, predicted blood lead

9 distribution or the blood lead distributions

10 that are observed in the empirical data and

11 point out the relative contributions of air to

12 those discrete blood lead estimates, or you

13 can focus on more of the concept of the change

14 in the blood lead, regardless of where you are

15 in an absolute basis, the relative

16 contribution of air to that delta in blood

17 lead. And those are two different, related

18 but different ways of communicating. I'd be

19 interested in understanding a little bit about

20 which path you plan to focus on.

21 And why I'm asking about teasing

22 apart the air contribution to all the other

Page 43

1 sources of exposure and the total exposure

2 pathways is: will you be able to tackle one

3 anticipated problem that the uncertainty in

4 the air pathway might be minor relative to the

5 uncertainty in everything else, the

6 uncertainty in everything else is swamping the

7 uncertainty in the air pathways? How do you

8 communicate that effectively? 

9 DR. PEKAR: Yes. That's a really

10 well-framed question. You know, I think if we

11 talk about high population percentiles in

12 terms of air risk, that uncertainty, and we

13 talked about this, I think, in presenting the

14 risk estimates last time, part of the reason

15 we really use these as sort of supporting

16 evidence for the evidence-based calculations,

17 I mean, really what the risk assessment last

18 time, and obviously we're approaching it in a

19 fresh perspective this time, last time what we

20 said was, because of some of the

21 uncertainties, the real utility of the

22 analysis is in supporting these evidence-based

Page 44

1 calculations and providing sort of reasonably

2 similar magnitude types of estimates that give

3 us overall greater confidence in the evidence

4 side of things. One of the things we said was

5 when we were talking about high population

6 percentiles in terms of ambient air risk,

7 because of some of these correlational issues,

8 there's a lot of uncertainty at that point

9 then. 

10 I think your point of other

11 pathways driving the air or dominating

12 uncertainty is probably more relevant in a

13 central tendency estimate of risk. But when

14 you start to try to push things towards the

15 distribution, towards the outer parts of the

16 distribution, then our ability to look at

17 correlations between pathways and really tease

18 out how those things contribute becomes pretty

19 substantial, and that's where a lot of the

20 policy-relevant kind of risk estimates are. 

21 And so we have a lot of uncertainty.

22 And the point I think I would make

Page 45

1 here is: do we think that our ability to

2 better characterize soil, and maybe shift you

3 a little bit on this distribution, meaning it

4 looks like maybe things have gone down a

5 little bit, let's say, is that magnitude of

6 change and refinement going to be notable in

7 the context of the broader uncertainty we have

8 in relating these things in the higher ends of

9 the distribution? And I think the story

10 always comes to that high air risk.

11 And so whether we talk about blood

12 lead, high blood lead driven by air or high IQ

13 loss, higher relative levels of IQ loss driven

14 by air, we still come to that sort of degree

15 of confidence or fuzziness around that. If we

16 tweak individual pathways within that without

17 better correlational information, are we

18 really in a better position? And I think our

19 assessment, in giving a hard look at what

20 we've seen, is we're not really in a better

21 position. 

22 That doesn't mean that the risk
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1 information doesn't continue to play that kind

2 of critical role potentially and we're going

3 to have to interpret it. But what it does

4 mean is that sort of tweaking some of these

5 other elements wouldn't really refine that

6 uncertainty at the higher end of distribution. 

7 So I'm not sure if that's an answer, but we

8 would speak to that. I would qualitatively

9 say in terms of magnitude. 

10 DR. GOODRUM: Yes, that gives me a

11 really good understanding about how you're

12 going to frame the uncertainty. And can you

13 speak a little bit to the first question about

14 whether you're going to focus on the high end

15 of either the IQ deficit or the blood lead? 

16 Are you going to focus on absolute estimates,

17 or are you going to focus on deltas? 

18 DR. PEKAR: Well, it depends on,

19 you know, the policy question being asked. I

20 mean, if we're looking at alternate standard

21 levels, we focus usually on deltas, having

22 greater confidence in that. I think that was

Page 47

1 a point we made last time is, you know, you

2 can look at a step down and you're not then

3 dependent also on the absolute level.

4 In terms of blood values, I think

5 we emphasized, my recollection was we

6 emphasized IQ loss increments to a greater

7 extent. But, you know, Deirdre has a better

8 memory for some of these things, so I'm going

9 to let you speak to this. 

10 DR. MURPHY: Well, I'll just

11 mention a couple of things. In terms of the

12 issue of absolute versus incremental, be it

13 blood lead or IQ loss, one of the issues was

14 we're interested in the impact associated with

15 air-related lead. And as Zach pointed out, in

16 the modeling simulations that we did, when we

17 simulated alternative air quality scenarios,

18 we were only changing the air signal in some

19 pathways, although we knew it existed in other

20 pathways. 

21 And so, in providing our risk

22 estimates, we did provide these ranges that we

Page 48

1 said were bounded by those pathways, the

2 estimates for those pathways that we did

3 simulate. We knew that was a low end. We at

4 least had that much risk for each of the air

5 quality scenarios, but we also knew it was

6 higher than that because we knew we were

7 missing the air signal in these other pathways

8 because we couldn't quantify changes in soil

9 concentration as a result or a function of the

10 different air scenarios we published. So we

11 simulated.

12 So that's why we tended to say,

13 well, if we just look at differences between

14 air quality scenario one and two, you're not

15 going to see the full impact of a change in

16 the air standard because you won't see how it

17 ripples through soil and diet and all the

18 rest, which are slower and perhaps harder,

19 definitely, from our perspective, harder to

20 characterize. And so we tended to put both

21 types of information on the table, and in

22 looking at the absolute risk associated with

Page 49

1 each of the air quality scenarios we had these

2 broad ranges, which we said the risk itself,

3 fell somewhere inside this range. It's higher

4 than the low end and it's lower than the high

5 end, but we don't know exactly where it is. 

6 So that's why it's hard for us to be precise. 

7 I mean, we looked at all of it and tried to

8 draw from it what we could.

9 DR. FREY: Okay. Chris? 

10 DR. JOHNSON: Perhaps I just

11 didn't understand. At the very beginning of

12 your presentation when you laid out the

13 different pathways, you made a comment that,

14 if I remember correctly, was something like

15 technical challenges prevented you from

16 modeling how the changes in ambient air

17 concentrations related to what was essentially

18 deposition, I guess, to soil, crops, and

19 water, I believe. Can you explain that a

20 little bit? It doesn't seem like it ought to

21 be that difficult but . . .

22 DR. PEKAR: Sure. So it's really
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1 -- let me be a little more clear about that. 

2 So what we're saying is the real challenges,

3 if we're talking about an urban setting and we

4 have some, in an urban setting you will have

5 elevated, relative to other locations, soil

6 levels because of, you know, anthropogenic

7 historical loadings, to a certain extent. So

8 if we ask ourselves, in terms of residential

9 soil exposure of children, if we change

10 ambient air lead, let's predict a change in

11 the sort of surface soil dust that they're

12 going to be exposed to, that's a pretty

13 challenging issue because you're not talking,

14 it's not like indoors where there's cleaning

15 and there's a clean surface and you can

16 predict indoor dust loading and look at a lead

17 component that's coming in from paint, which

18 is what we did. Outdoors, you have a much

19 more complicated sort of historical signal

20 that's in there, and predicting how that

21 changes is complicated and has probably a

22 temporal profile that's also complicated to characterize.

Page 51

1 So because of some of those

2 challenges, we found it really difficult to

3 have that as part of the dial that was being

4 dialed down as we looked at alternate standard

5 levels. I'm not sure if that helps. 

6 DR. JOHNSON: What about crops and

7 water then?

8 DR. PEKAR: Well, the thing about

9 that is if we're looking at a standard level

10 in like an urban setting, you have a gradient

11 of exposure, well, you know, relating that to 

12 ambient levels that would be impacting crops

13 in a distant sort of agricultural area is

14 going to be a more complicated process. I

15 mean, how is the standard level here and that

16 standard going to affect necessarily a

17 generalized kind of crop exposure scenario

18 where you have commercial crops being raised? 

19 So it's hard to simulate that on the one hand,

20 you know. So, I mean, obviously, in the

21 Superfund context, you can model dietary

22 exposure and uptake and other things, but I

Page 52

1 think it's more of that what would a NAAQS

2 change mean in terms of sort of a crop market. 

3 The linkage. How would you link when you have

4 dairy sheds and crop -- there's a complexity

5 there. And we also felt that, I think that if

6 you look at overall exposure, and I've had to

7 look at a fractional contribution, I think

8 you're having a pretty high driving, you know,

9 overall exposure is being driven by soil

10 outdoor ingestion and indoor dust ingestion in

11 the residential context and not so much by

12 dietary exposure. So we figured,

13 qualitatively, that probably wouldn't be as

14 critical a contribution. 

15 DR. FREY: Okay. George? 

16 MR. ALLEN: First, thanks for a

17 good summary of this process, part of the

18 process. I guess one question I had after

19 some spirited dinner conversation with Rich

20 last night related to the inhalation pathway,

21 which we normally and you said, I think, today

22 was, you know, very small, less than one

Page 53

1 percent, if I recall correctly. But then we

2 have one or two studies looking at blood lead

3 near general aviation airports showing

4 something that appears to be real: there's

5 elevated blood lead within 500 meters or

6 something.

7 And since I'm assuming that it's

8 combustion mode lead and probably doesn't

9 deposit near field to the soil in that

10 scenario, then my first thought is maybe the

11 pathway is primarily inhalation. And the

12 question is, with that specific scenario,

13 which is now maybe one of the dominant

14 scenarios now that smelters are, more or less,

15 history for combustion-related lead exposures,

16 smelters and tailpipe lead, what is the

17 efficiency of inhalation of fine mode aerosol

18 lead? If you breath it in, how much of it

19 comes out? Do we have any feel for that? And

20 maybe, in this scenario, is inhalation the

21 primary pathway?

22 DR. PEKAR: Certainly, you know,
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1 we have simulations in the case studies that

2 would look at ambient levels and direct

3 inhalation. We could look at what that means

4 in terms of blood lead and IQ impacts. The

5 question of the difference in the nature of

6 lead, you know, maybe near airports is

7 something that I think, in the context of that

8 scenario, would be something we would look at

9 and consider. Deirdre, I don't know if you

10 want to take a look at --

11 DR. MURPHY: I'd just offer one

12 thing because one thing I did a little bit in

13 the last one was with the inputs to the IEUBK

14 model for respiration and the absorption,

15 which I think is part of what you're asking

16 about, and we did use different, I can't

17 remember the name of the element, but there's

18 essentially a different input for the urban

19 scenarios versus the smelter case study that

20 we used, which was a function of a different

21 assumption on particle size distribution. And

22 so I think that gets at what you're talking

Page 55

1 about. The urban scenarios presumed more

2 finer particles as part of that mix, and so I

3 think that does lead to what, that would be

4 useful to look at again in the context of the

5 question that you're raising to see what that

6 particle mix and how it might relate to that. 

7 But I think it, generally, was intended to

8 represent more urban mixes of particles, which

9 would tend to be I think dominated by the

10 combustion type sources. 

11 MR. ALLEN: Well, urban is both

12 sizes. But in this particular case, maybe

13 it's pretty unique for urban exposures for

14 combustion mode, meaning fine mode. The only

15 source I can come up with is JA airports now,

16 now that tail pipes are clean.

17 DR. MURPHY: It will be

18 interesting to see what evidence we have on

19 that, on the particle mixtures near airports. 

20 I'm not sure that there are good data sets on

21 that yet, but that would be something to look

22 at closely based on this issue. 

Page 56

1 The other thing I'll mention is

2 just the point you said about perhaps airports

3 are now the dominant scenario. I don't know

4 that we have information that that's the case

5 either. We still have, you know, we have 21

6 areas that are not meeting the current

7 standard, and those are not near airports. 

8 And so I think we still feel that some of the

9 higher concentration areas in the country are

10 near these point --

11 MR. ALLEN: Yes, I'm sorry, I

12 should clarify that. Urban non-source,

13 assuming you don't think of GA airport as a

14 source, maybe it is, non-source scenarios,

15 then these things are everywhere next to our

16 neighborhoods. You don't have smelters

17 usually next to neighborhoods, although I

18 guess occasionally you do. And as has been

19 noted, you know, it's half the lead inventory,

20 and half to that half is assumed to be near

21 ground, not up there. And even if it is up

22 there, it comes down somewhere. So the

Page 57

1 potential for exposure both near airports in

2 a very enhanced way and then, of course, very

3 broadly of varied background exposure is

4 there. And this lead study, okay, what's the

5 pathway of exposure? I don't think it's dirt,

6 which kind of leaves inhalation. And I'm just

7 saying I guess the message that I'm getting is

8 we don't usually think of inhalation as much

9 of an interesting pathway, but in this

10 scenario maybe it is. That's the question. 

11 I can't think of any other way to have it make

12 sense. 

13 DR. MURPHY: I think you're

14 raising a point that we'll need to consider in

15 the policies. 

16 MR. ALLEN: Okay. Thanks. 

17 DR. KOSNETT: Thanks very much for

18 your presentation. It was great, Zach. Thank

19 you. I notice that you said that there was

20 some refined information on the GSD. That's

21 always interesting because it has such an

22 impact on IUU decay. Can you just briefly
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1 comment what that refined information is? 

2 DR. PEKAR: And, actually, I could

3 comment if I actually had my other notes up

4 here, which I don't. You know, we'll be

5 talking about that. I can actually pull those

6 up, this is a very lame response that I don't

7 like to give usually up here, and I can talk

8 to you about that offline. I have notes on my

9 computer. I just didn't bring them with me up

10 here, and I don't want to speak sort of from

11 memory without looking at those. But, yes, I

12 can talk to you about that. 

13 DR. KOSNETT: Thank you.

14 DR. FREY: Okay. Any -- yes, I

15 think Ed wants to make a point.

16 MR. HANLON: Zach, for the FACA

17 meeting discussions, what we'd like to do is

18 ensure that discussions with the public, which

19 would include you, with the panel members

20 occur in the open forum that we have here. 

21 DR. PEKAR: Oh, sure. 

22 MR. HANLON: So if we can try to

Page 59

1 encourage those discussions, offline

2 discussions, we do not meet the requirements

3 of FACA. 

4 DR. PEKAR: Sorry about that. 

5 Okay. 

6 DR. FREY: So I guess that's a

7 quandary then for exchanging that information. 

8 DR. MURPHY: So if I could

9 interject, just to clarify, was the

10 information just to understand which studies

11 it was? I mean, we could certainly send the

12 panel --

13 DR. PEKAR: So let me at least

14 speak to what I recall. 

15 DR. FREY: Zach, just to clarify,

16 if you don't have the information now and you

17 would like to provide it in an accurate way,

18 you could send it to Ed in writing, and then

19 we can receive that, I guess, essentially as

20 a public comment.

21 DR. PEKAR: Right. Okay. We can

22 do that. I can also just, for instance, even

Page 60

1 if the mean blood lead values have been

2 decreasing, I think there's some evidence some

3 of the higher end levels are still left there,

4 which means the GSD can actually get wider

5 because you have some individuals that are

6 still left at the tails at the higher ends

7 because of paint, even if the central tendency

8 values tend to get lower, which they are. So

9 reflecting that kind of, that additional GSD

10 information, we would talk about the degree to

11 which that could be used to simulate blood

12 lead values that are higher. But, once again,

13 this sort of, I think the overall qualitative

14 conclusion that we would reach is that, even

15 if we would generate somewhat different total

16 blood lead values and total risk estimates,

17 we're still hampered, to a certain extent, by

18 this uncertainty in teasing out the air19 related exposures in those high-end children. 

20 And there's complexity here in the way we use

21 these GSDs and what they mean. This is

22 something that was discussed a little bit

Page 61

1 yesterday. You know, these GSDs are really

2 characterizing variability in a neighborhood

3 to a larger population of children, depending

4 on the study which can reflect a number of

5 different factors: biokinetic variability,

6 exposure pathway variability, other factors. 

7 And so even when we use these GSDs to get sort

8 of a total lead risk, which is what we do, we

9 simulate total exposure and risk for a central

10 tendency using IEUBK, we can pathway a portion

11 of that. But when we go and we put a child on

12 the high end of that distribution, we're

13 still, even if we have a different point on

14 that high-end distribution, we're still

15 hampered by our ability to tease out the

16 pathway contributions to that child. 

17 So we would talk about, you know,

18 maybe it looks like the risk estimates might

19 be slightly higher for a 95th percentile child

20 let's say because if the GSD has gotten wider,

21 for instance, has gotten larger, excuse me,

22 the distribution has gotten wider, our ability
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1 to still tease out the pathway contributions

2 might be still challenging and would remain

3 the primary source of uncertainty that really

4 isn't addressed by that new GSD. So I'm not

5 sure if that helps a little bit. 

6 DR. KOSNETT: It's certainly

7 interesting, and I think we would be happy to

8 look and comment on that because, you know,

9 Phil knows this better than anyone I know that

10 my understanding is that the GSD and the IEUBK

11 should really be intended to model the

12 biokinetic variability, the variability that

13 would exist around a group of children who had

14 the same exposure. And we've been in

15 situations, we were on another panel where we

16 talked a lot about this on dust. We were on

17 the EPA's, you know, indoor dust panel. We

18 had long discussions about this. But I'm just

19 saying it becomes a big issue in the risk

20 assessment, so we'd be happy to give you input

21 if that's something we can do. 

22 DR. PEKAR: I think that would be

Page 63

1 good. And we'll be framing that. I think,

2 depending on where the GSD was derived from,

3 obviously some of the GSDs that -- we had a

4 whole discussion on this in the analysis, and

5 some of the GSDs that come from larger data

6 sets clearly are going to reflect a variety of

7 house types, ages, and other things. So you

8 get a bunch of other factors, sort of a degree

9 of cleanliness in the house, all of this kind

10 of stuff. Obviously, if you get a smaller,

11 tighter neighborhood assessment, then you hope

12 to control and have more consistency in some

13 of those other variables and just focus on

14 biokinetic variability, but I think it's hard

15 to get a pure biokinetic GSD from empirical

16 data like that, unfortunately. I mean, that's

17 my take on it. But when we make those points,

18 a comment on that would be very valuable, I

19 think, to us, particularly in the context of 

20 specific GSDs from specific study data sets

21 that we cite would be very useful. 

22 DR. FREY: Yes, and maybe just to

Page 64

1 clarify when we're talking about commenting

2 and providing advice and so on, so what we

3 have in this case, we don't actually have

4 charge questions right now on the REA or the

5 policy assessment. If we, as a panel, felt

6 there were things we wanted to say now, we

7 could do that through the CASAC as a separate

8 letter from the comments on the ISA, and that

9 would be kind of analogous to a consultation

10 in that we're not responding to a charge

11 question and it's just advice. 

12 I think what you're intending,

13 Michael, is that when we get the first draft

14 policy assessment we'll see more about what

15 Zach actually did compared to what he says

16 he's going to do. And at that point, we can

17 provide detailed review in response to charge

18 questions.

19 So I guess just think about if

20 there's anything you feel is important for

21 CASAC to say now versus we can wait and see

22 how, I guess, the interpretations of the REA

Page 65

1 and the qualitative uncertainty assessment and

2 to whatever extent there's quantitative

3 assessment, how that turns out when we meet,

4 probably in October will be our next meeting. 

5 And at that time, we can provide detailed

6 responses to what they've actually drafted. 

7 Okay? 

8 DR. KOSNETT: And if they wanted

9 to, knowing that we're going to review it, if

10 they wanted to send us stuff early, that's not

11 good, right? 

12 DR. FREY: Well, there's a formal

13 review process, so when they release a draft,

14 they'll release a first draft PA, policy

15 assessment, for us to review, and that would

16 be the typical procedure. 

17 DR. VU: I know that, for this

18 review, the agency deviates from the typical

19 process. I do know in the previous, when you

20 look at ozone or PM, the agency will present

21 an integrated, I mean a scoping for risk and

22 exposure assessment, and then you have a
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1 consultation. In this particular case,

2 because the agency doesn't believe this new

3 information, so they incorporate the REA and

4 the policy assessment into one single

5 document. And this meeting is just a preview

6 of what's upcoming, and I think Dr. Frey is

7 saying is that you all have an opportunity to

8 look at the draft that they will present, the

9 agency will present in the fall. And then if

10 you're not satisfied, of course, you can ask

11 for a second draft. So this is just a

12 preview, and OAR did not ask us to do a

13 consultation of a plan. So this is,

14 basically, where we are.

15 DR. MURPHY: If I could clarify,

16 we did have a consultation on the REA planning

17 document, and we do have all of your

18 individual comments attached to the CASAC

19 consensus letter on that consultation, which

20 we will be considering as we put together the

21 presentation in the policy assessment, as well

22 as the comments that you all have raised. We

Page 67

1 have the transcripts from this meeting, and so

2 we'll be able to consider that in putting

3 together the first draft policy assessment,

4 and there will be two drafts of the policy

5 assessment. 

6 DR. VU: Deirdre, I think there's

7 a difference between the integrate plan, which

8 is the outset. I'm talking about the risk and

9 exposure assessment. 

10 DR. MURPHY: And I'm not mixing

11 those either. We did develop an integrated

12 review plan. That was earlier last year. 

13 Then we developed an REA planning document,

14 and that was the topic of consultation at the

15 July meeting that this panel had. And so I am

16 distinguishing those two different things. 

17 DR. VU: Thank you, Deirdre. 

18 DR. FREY: Okay. Any other

19 questions, comments, on the risk and exposure

20 assessment? Seeing none, I think, Deirdre,

21 you wanted to tell us a bit about the policy

22 assessment. 

Page 68

1 DR. MURPHY: Just one or two

2 slides here to prepare you for what you will

3 see in the fall. So Zach has described a

4 house, if you will, of the policy assessment,

5 and I'm just going to give you an idea of the

6 home that that -- no, he described a room. 

7 Sorry. I'll give you the home that the room

8 will be in. 

9 So this is generally the outline

10 of information that will be presented in the

11 policy assessment with purpose and background

12 to orient folks. And then there will be a

13 chapter on ambient air lead, and in that we'll

14 actually be touching on some of the things you

15 talked about yesterday: information on

16 sources, including what we know about aviation

17 gas emissions; ambient air quality, what we

18 have from that information; there will be a

19 wrap-up in that chapter, as we're envisioning

20 now, that will be ambient monitoring

21 considerations, which will take on some of the

22 policy relevant questions that we identified

Page 69

1 in the integrated review plan with regard to

2 monitoring. Our intention is to revisit them,

3 and that's why we post them in that plan.

4 Then we'll have a chapter on

5 health effects and exposure risk information

6 where we'll be summarizing information from

7 the ISA on health effects, beginning with

8 information on the predominant use of blood

9 lead as a biomarker, characterizing the nature

10 of effects, etcetera. We'll have the

11 presentation of the exposure risk information,

12 as we've briefed you on here. There will be

13 a section on public health implications,

14 trying to draw all of that together to see

15 what does it tell us about public health

16 implications of ambient air lead. 

17 And then we'll go through review

18 of the primary standard for lead, the question

19 of is the current standard adequately

20 protecting public health with adequate margin

21 of safety. Then we'll move on to welfare

22 effects and the corresponding presentation
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1 there, which will mirror how we've done it for

2 the health chapter, and a review of the

3 secondary standard.

4 So that's, generally, the

5 intention for the document that you guys will

6 be seeing in September of this year as a first

7 draft. And then this next slide, which is the

8 schedule that Lydia showed yesterday, shows

9 you that we intend to bring to you two

10 different drafts of that. The first draft

11 will be in September. And then after we

12 receive your comments and revise based in

13 consideration of those comments, we'll be

14 providing you a second draft which currently

15 is scheduled out into early 2013.

16 DR. FREY: Okay. Great. I was

17 just curious, I guess yesterday we heard a

18 presentation on monitoring from Mr. Cavender,

19 and he mentioned that I guess there's some new

20 monitors that have been collecting data in

21 2010 and those should be certified in about a

22 month. Would that data be taken into account

Page 71

1 in the policy assessment?

2 DR. MURPHY: Right. So the issue

3 we always face is when do we do the data pull

4 is kind of a phrase that our air quality guys

5 use. And they've done a data pull for the

6 ISA, as you see in the presentation there. 

7 And the window is sort of closing on that

8 presentation. But we're aware that we have a

9 longer window going into the policy

10 assessment, and so we'll be trying to do that

11 data pull when it's most effective but still

12 allows us time to present those data and write

13 them up appropriately. So it's not clear to

14 us exactly which monitors will be included in

15 that, but we'll be trying to make it as

16 inclusive as possible and also recognize that

17 there will be two drafts of that assessment. 

18 So if there's some need to reconsider what

19 data are included, we can do that. 

20 As Kevin mentioned, while there

21 are different dates by which monitors had to

22 be implemented, there is some lagging across

Page 72

1 some of it. And so we may not have complete

2 data sets, and we'll be considering that, as

3 well. But there will be as much presentation

4 as we can provide. 

5 DR. FREY: Okay. Yes, it seemed,

6 if I understood that correctly, that it might

7 provide some insight on the source-oriented

8 exposures and possibly, I don't know whether

9 that would have implications for the REA, but

10 it seems like something that would be good to

11 take a look at.

12 Other clarifications or questions

13 or comments from the panel on what we've heard

14 regarding the policy assessment? Okay. I

15 don't see any. Well, Dr. Pekar, Dr. Murphy,

16 thank you very much. 

17 DR. MURPHY: Thank you very much.

18 DR. FREY: We're at the part of

19 the agenda where we can provide an opportunity 

20 for clarifying remarks from members of the

21 public. And I think, for this purpose, I'll

22 ask the DFO if we've been contacted. Also, I

Page 73

1 guess maybe I'll defer to Ed on checking if

2 members of the public are on the phone who

3 want to make such comments. 

4 MR. HANLON: So as of this time,

5 we have not received any requests for public

6 comment or requests for clarifying comments. 

7 Are there any requests from the public for

8 that? So hearing none, Chris? 

9 DR. FREY: Okay. All right. So

10 we now have time in the remainder of our panel

11 meeting for discussion. And it seems to me

12 there are a number of topics that we should

13 discuss. One is, while it's fresh, is whether

14 there are any significant issues that we want

15 to raise as a panel in sort of an advisory

16 capacity regarding what we've heard on the REA

17 or the PA. And if so, then there may be a way

18 to convey that possibly separate from the

19 letter that we use to review the ISA. I think

20 we did hear that both Dr. Pekar and Dr.

21 Murphy, of course, are aware of our discussion

22 today, aware of our prior comments on the
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1 consultation related to the REA. So the

2 extent there's anything that would go beyond

3 that, I just want to open the floor for that

4 if any members feel so moved. Phil? 

5 DR. HOPKE: Yes. I haven't heard

6 any mention of having anybody look at the

7 residual risk analyses that would have had to

8 have been done following the MACT efforts on 

9 the secondary and primary lead smelter and

10 wondered whether there was some potentially

11 useful additional information in those

12 residual risk assessments that could help to

13 inform the risk assessment here. All of that

14 should be well done, you know. It may be old

15 stuff by now, but it certainly might be worth

16 a review just to make sure that there was

17 something that they spotted that wasn't in the

18 current risk assessment. 

19 DR. FREY: Okay. Any thoughts? 

20 So I take it by the lack of more discussion

21 that the panel is in sort of passive

22 concurrence that the premise of what EPA is

Page 75

1 doing, to the extent that there isn't

2 substantial new evidence to support new dose

3 response models for IQ effects or to look at

4 other end points, that that is a reasonable

5 state of the science at this time and so on. 

6 And if there's any disagreement with that,

7 this would be the time. But I think we did

8 discuss that a bit at our last meeting, as

9 well. Okay. All right, good.

10 Well, then I think what I'd like

11 to do is talk just a little bit reflecting on

12 some of the presentations we heard yesterday

13 morning on monitoring and aviation gas, and

14 then let's come back to the charge questions

15 on the ISA. So on the monitoring, we heard

16 both about the current work to implement some

17 additional monitors for lead using current

18 sampling and analytical methods, and then we

19 heard a presentation on the development of a

20 new sampling method for ambient lead. Are

21 there -- well, let me put it this way: as

22 CASAC, what we can potentially do, not

Page 76

1 necessarily right away, but as that work

2 develops that Dr. Vanderpool described, we do

3 have another committee on CASAC that is the

4 AAMMS, and I never remember what that stands

5 for but I think of it as the ambient

6 monitoring committee -- yes? Ambient

7 Monitoring and Methods Subcommittee. So they

8 are I think better constituted to review

9 monitoring technology than our panel is

10 because our panel is aimed at a very multi11 disciplinary look at a lot of issues. And so

12 CASAC could, for example, express interest and

13 support for what EPA is doing and also

14 interest in having an opportunity to take a

15 look at that through the monitoring committee,

16 and that's kind of my inclination is to

17 recommend that to the seven-member statutory

18 CASAC, and then that group could craft a

19 letter to the administrator that would express

20 that view. I want to just mention that and

21 see if there are any comments or discussion or

22 suggestions related to that. Yes? Phil?

Page 77

1 DR. HOPKE: That seems like a very

2 sensible way to approach it. There's several

3 of us here who are on that subcommittee and

4 others who could bring in their expertise, and

5 I think that would be a very good way to

6 provide some additional input. 

7 DR. FREY: Okay. And, George,

8 you're seconding? 

9 MR. ALLEN: Yes. 

10 DR. FREY: Okay. Any other

11 thoughts or discussion? Okay, good. All

12 right. And then we had a presentation

13 yesterday on aviation gasoline, and we did

14 have some clarifying discussion after that. 

15 I just wanted to provide an opportunity if

16 there were any further thoughts related to

17 that topic. That did come up this morning in

18 the discussion of the risk and exposure

19 assessment, and there may be some, as George

20 suggested, some nuances to that where, you

21 know, maybe locally inhalation perhaps is more

22 important than with some of the other exposure
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1 scenarios. But is there anything in addition

2 any of the members of the panel would like to

3 offer on that topic? I'll just open it up for

4 discussion. Rich? 

5 MR. POIROT: I've just been

6 thinking that it strikes me as the kind of

7 source that may not necessarily lend itself to

8 the highest concentrations kind of an effect

9 but which is more broadly distributed than

10 many of the other kinds of sources. I'm

11 remembering from last time, you know, someone

12 suggesting, posing the question of what's the

13 overall effect on society of everybody being

14 attentive an IQ point dumber, you know, that

15 sort of a thing. At any rate, that was one

16 thing that struck me about the nature of that

17 source is that it might not lead to the

18 highest exposure at the location in accedence

19 of the current NAAQS but, on the other hand,

20 is so much more broadly distributed that it's

21 important in that way. 

22 DR. FREY: Yes, I think that's a

Page 79

1 good point. And I guess, although, at the

2 same time, if we think of a landing and take3 off cycle that's producing the emissions, the

4 take-off mode is typically a high-power mode

5 that's very close to the runway at low

6 altitude and then the climb out. And often

7 with, I guess, aviation, air quality modeling,

8 once the plane gets above 3,000 feet or the

9 mixing height, then people tend not to worry

10 so much about it. But I think, as you're

11 saying, if you're dispersing a lot of

12 particles, maybe even at high altitude, and

13 some of these planes don't fly at very high

14 altitude, that there could be broader

15 dispersion at low levels, and so maybe there

16 is a low level effect. So I think, yes,

17 that's a difference in the source category

18 versus, say, a lead smelter.

19 MR. POIROT: If I could add one,

20 you know, I had suggested yesterday that the

21 idea of presenting a list of the largest

22 sources that would be, you know, a counterpart

Page 80

1 to the largest source categories and expecting

2 probably airports are not going to show up on

3 that list of the largest sources. But to back

4 off and modify that, thinking a little bit,

5 if, on the other hand, we were doing sort of

6 a population weighted concept of large

7 sources, quite possibly airports would be

8 something that affects a large population in

9 a general way.

10 DR. FREY: Yes. So maybe just to

11 say something, and then Phil. So this may

12 have some implication for the ISA because

13 these seem like things that could be discussed

14 in the ISA, to the extent they're not in there

15 now. Phil? 

16 DR. HOPKE: Yes. I know that TRB

17 had funded a study of lead from airports

18 starting last year. I don't know where it

19 stands at this point, but those are always

20 pretty short-term kinds of efforts. And so it

21 certainly would behoove the EPA to check with

22 the people at TRB, the NRC TRB people, to just

Page 81

1 see where that study is and whether it could

2 provide some useful information to the policy

3 assessment. 

4 DR. FREY: Yes, that's a good

5 point. My understanding of the timing of that

6 study is that it's going to kind of optimally

7 miss the timing of what we've heard, that it

8 will be done probably in the end of 2013 or

9 something like that. So just when everything

10 is getting finalized here, it will available. 

11 But, yes, to the extent that any preliminary

12 results are available -- of course, there is

13 the criteria that's described in the preamble

14 where EPA wants to use peer-reviewed data, so

15 I don't think it will satisfy that criteria

16 during the time frame of this review cycle,

17 which is frustrating but there will be quite

18 a lot of good data probably in another year or

19 two. Yes, Mike? 

20 DR. RABINOWITZ: Just a small

21 question. Do we have any data on blood lead

22 levels of pilots or people who ride these
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1 gasoline-driven planes that use tetraethyl

2 lead? 

3 DR. FREY: I personally don't. 

4 I'm sorry. Rick? 

5 DR. CANFIELD: Just to dispel some

6 of my ignorance, does anyone know is the

7 leaded fuel used in helicopters, as in Flight

8 for Life and those kinds of transportation

9 helicopters going back and forth over

10 Manhattan all the time? 

11 DR. FREY: Phil, do you want to

12 use the mic? 

13 DR. HOPKE: I thought most of

14 those were turboprops, and so they'd be

15 fueling with Jet-A, not with gasoline. 

16 DR. FREY: Yes, I think that's,

17 and that's also why that what we might think

18 of as a propeller plane used for commercial

19 aviation, which is actually a turboprop, is

20 not really within the scope of what we talk

21 about with aviation leaded gas with a piston

22 engine. So, yes, to the extent, I think, I

Page 83

1 don't know for sure, but I think they tend to

2 be more turbo than piston-driven. 

3 Any other thoughts on the aviation

4 gas topic? Okay. Well, so what I'd like to

5 do then is return to the charge questions, and

6 I wonder if we could put on the screen -- do

7 you have the file for the draft responses to

8 the charge questions? Okay. So if we could

9 start with chapter three, and I think what we

10 want to keep in mind as we go through this is

11 do we answer the charge question? We want to

12 make sure to answer the charge question. 

13 Something else is are there things that have

14 implications for synthesis across chapters of

15 the document and, particularly, also

16 implications for tying concepts together in

17 chapter two? And then also what are the key

18 points to distill from these charge questions

19 responses that should go in the letter to the

20 administrator? And what would be the key

21 priorities or really the essential things that

22 are critical if I think we're going to be

Page 84

1 asking EPA to give us a third draft ISA for us

2 to review, and we don't necessarily need to

3 review the entire ISA at the same level of

4 detail. I think that review is going to focus

5 on chapter five and the correlated material in

6 chapter two. But to the extent there's

7 anything really critically deficient in the

8 current draft of the ISA, I think it would be

9 good to make sure we convey that priority to

10 EPA.

11 Okay. So perhaps the procedure

12 for this might be if the lead discussant on

13 the charge question could try to briefly

14 summarize, and we don't necessarily need to

15 read it word for word but maybe the main point

16 of each paragraph. And then we could have

17 some discussion as to whether this is

18 answering the charge question or whether it's

19 complete, whether it has implications for

20 synthesis across the document, and what are

21 the implications for the letter. So with

22 that, George, would you be ready to start us

Page 85

1 off? 

2 MR. ALLEN: Sure. Thanks, Chris. 

3 All right. Well, the approach I took was,

4 indeed, to specifically address the charge

5 questions for chapter three. This first

6 paragraph with the italics refers to the list

7 of changes, which is what the first part of

8 the charge question is about. There's a bunch

9 of bullets on the administrator's, on the

10 attachment to the March 23rd administrator's

11 response to the CASAC review of the first ERD. 

12 And so I didn't repeat that here because it

13 was scanned and I couldn't copy/paste it, but

14 it refers to it. 

15 And what I said was, oh, okay,

16 there's a whole bunch of these and we're okay

17 with all of them except the following four,

18 which I then specifically address here. And

19 I put the section numbers in there, and the

20 first one is the issue of air lead emissions

21 from domestic wood burning. Well, sorry, wood

22 burning, but I'm talking domestic wood
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1 burning. And I seem to be the only one

2 focusing on this, but I think there's

3 something there that needs a little more

4 attention. 

5 This ties indirectly to, as John

6 Vandenberg pointed out yesterday, to a brief

7 piece in chapter four where they cite a study

8 that is actually quite interesting, despite

9 having a P of only 0.06 for the very small end

10 of 18 samples for people who had exposure. So

11 that's one piece, and I guess it will come

12 back up again in chapter four.

13 And then there's the TSB FRM

14 revisiting sampling methods, which we've

15 talked, pretty much talked to death so I won't

16 go over what I wrote here. There is always

17 the issue of is this within the scope of an

18 ISA. Traditionally or technically, no, but

19 it's the gorilla on the block, in part,

20 because it does keep coming back again and

21 again and again and again every time CASAC has

22 a chance to get near it.

Page 87

1 And we did hear some really good

2 material from Bob Vanderpool yesterday saying,

3 yes, we're working on it. Now, that whole

4 process of we're working on it doesn't make it

5 into the ISA, and maybe it doesn't have to. 

6 But on the other hand, there's a bit of

7 disconnect if there's no mention of the

8 current activities. Again, this is very

9 untraditional ISA stuff, but, hey, it's there. 

10 It's going on, and it's relevant. 

11 Many people commented that we

12 didn't really want that AQS data table that

13 was in the first draft in the appendix, Table

14 3A-13, didn't want it removed. We didn't like

15 some aspects of it, but we thought it could be

16 fixed, but it just got removed. We would like

17 it put back in with the fixes described in our

18 comments on the first draft of the ISA. And

19 really this is all because there isn't much

20 information on size, ambient air lead size. 

21 It's pretty limited. And there is information

22 in AQS that was summarized and is really

Page 88

1 useful to have back, so the message is don't

2 remove it, fix it, essentially. On the same

3 lines with, okay, let's use everything we can. 

4 I believe there was some discussion that there

5 might be material in the Cho paper, the 2011

6 Cho that is not included that may be relevant

7 in this context, as well as the Cavender

8 Schmidt EPA memo on this topic that was I

9 think in the first draft ISA and disappeared -

10 - no? Rich can maybe clarify that. 

11 MR. POIROT: Well, yes. The

12 Cavender Schmidt memo actually came out in the

13 last NAAQS review cycle right at the end of

14 the process. But just to clarify that a bit

15 also, one of the problems we had with the size

16 distribution information presented in the last

17 draft of this ISA is that a lot of the data

18 sets were identical to those used in that

19 earlier memo but the answers were different. 

20 So that was one of the problems we had with

21 it. If the more recently done comparison

22 could be repaired, there wouldn't be any need

Page 89

1 to also bring that memo up. I suggested that

2 yesterday as if there wasn't time or

3 something, at least --

4 MR. ALLEN: Okay. So really it's

5 just connecting those two dots and making sure

6 that's part of the fix, which, again, we just

7 need to go back to our comments from the first

8 draft. Okay. And then the background air

9 lead levels, there was some discussion of that

10 that it's kind of open-ended and that maybe

11 some constraints could be put on it. 

12 Other comments, again, responding

13 to the charge in general. The material is

14 clearly presented. There's some pieces that

15 could be made more clear in terms of the

16 reading, and I kept thinking as I read it, you

17 know, as additional parsing and synthesis of

18 some of the literature results really could

19 make it much more readable and accessible, and

20 so you don't have to refer to the references

21 to understand some of the summaries of the

22 results.
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1 One case that comes to mind is

2 some of the methods and size distribution

3 material don't mention the methods used, and,

4 therefore, it's hard to interpret because it's

5 all about sampling method when it comes to big

6 lead particles. 

7 There was a lot of discussion,

8 sometimes heated, about Spearman rank when you

9 talk about the multi-pollution material in

10 section 3.5.4. I don't know if we have

11 consensus on that, but this is maybe a good

12 time to open that up, the Spearman rank versus

13 Pearson or some other parametric for this

14 purpose or both or maybe evaluating both and

15 only presenting the one that makes sense,

16 that's defendable. And also filtering in some

17 of these results so that we're only looking at

18 the stuff that has some meaning, as opposed to

19 everything which just means you have to work

20 harder to get at the stuff that has meaning,

21 would be useful.

22 And then there's linkage in

Page 91

1 general between chapter three and the exposure

2 part of, air exposure part of chapter four. 

3 And just one example here again is that wood

4 smoke topic, and I'd just cite the two pieces

5 that are there but, actually, as John

6 mentioned, I wasn't aware of the one in

7 chapter four because I hadn't read it

8 carefully. So that's a brief overview of my

9 first effort on this. 

10 DR. FREY: Anything that is

11 missing here? Does anyone think anything is

12 missing or any general comments on this draft? 

13 I have a few sort of comments or questions. 

14 I think on the issue of the correlation, I

15 personally think it would be okay to have both

16 Spearman and Pearson but explain what they

17 mean. And then I think part of the comment

18 was just don't use them for everything, like

19 if there's some plausible reason why you

20 expect a relationship. 

21 DR. HOPKE: What relationships are

22 they trying to highlight here? I mean, what

Page 92

1 does it mean to have a relationship with one

2 of the other criteria pollutants, you know,

3 particularly ozone for example, so they co4 vary? 

5 DR. FREY: Right. So if they co6 vary, is there a mechanistic sort of a

7 plausible reason for that? 

8 MR. ALLEN: Sometimes, pardon the

9 expression, it's throwing mud at the wall to

10 see what sticks. 

11 DR. FREY: Rich? 

12 MR. POIROT: Yes. I had, along

13 similar lines, it wasn't really so much the

14 occasional use of the Spearman as it was the

15 changing from one to the other and some, to

16 me, very illogical results in some of those

17 perfect 1.0 correlations between lead and some

18 of these other pollutants absolutely don't

19 make sense. So if we're going to be picking

20 on the correlations, that's a point to raise. 

21 There was a table presented in there, Table 3-

22 10, that showed correlations between lead and 

Page 93

1 other pollutant species in TSP, PM10, and PM2.5

2 that had numbers in it that I absolutely don't

3 believe and can't imagine how they could have

4 possibly been published where you've got no

5 correlation between lead and an element in

6 TSP, 0.99 correlation between the same element

7 and lead in PM10, and a negative correlation

8 in PM2.5. That's just not remotely possible in

9 any way that I can imagine. So if we're going

10 to be picking on things, that's one I'd like

11 to pick on. 

12 But the last point I wanted to

13 make along those lines is the one set of

14 correlation data that I thought was useful and

15 informative was the correlation using the CSN

16 data and among all the different measured

17 species. And to me, there was some

18 potentially useful information in there. And

19 in the appendix, George, that presents those

20 correlations seasonally, and for both the

21 winter and fall season the second highest

22 correlation of lead with anything is with
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Page 94

1 potassium. So if you're looking for some wood

2 smoke, you know, possible suggestive

3 information, I don't know what else you'd be

4 driving at. 

5 DR. FREY: I guess on this point

6 of the mechanistic or science-based

7 interpretation of these correlations, it seems

8 like that's worth writing into the response to

9 the charge question that that's one of the

10 things that we're looking for. Phil?

11 DR. GOODRUM: I'll just weigh in

12 again because I weighed in before. I think I

13 totally agree with what I've heard in terms of

14 questioning the results that you see from the

15 correlation coefficients that look to be too

16 high or implausible. But that's different

17 from critiquing the use of the Spearman rank

18 correlation itself, so I'd like to propose

19 that in our consensus comments maybe we ask

20 EPA to provide for the reader a paragraph that

21 says, you know, some of the data in the

22 literature were reported using Spearman rank

Page 95

1 and some are reported in Pearson R, here's

2 what the difference is, so a little bit of an

3 up-front methodology description. And then

4 I'm okay with kind of flip-flopping as they

5 discuss the literature. It's clear that, you

6 know, they're basically synthesizing the

7 information as presented, rather than doing a

8 re-analysis. But I would be opposed to

9 discarding studies that present Spearman rank

10 correlation just on the fact that they use

11 that methodology. I think it's a totally

12 acceptable correlation analysis technique. 

13 DR. FREY: Okay. It sounds like

14 that's a good suggestion to fold into the --

15 okay, great. I guess a couple of points I was

16 thinking of. I know, Phil, when we had the

17 presentation on the sampling, you expressed

18 some concern about I guess what I think of as

19 a design-based sampler versus a performance20 based sampler. And I wonder if the

21 implication for the ISA is just to maybe say

22 a little bit about what those things mean,

Page 96

1 that one could design a sampler to meet

2 certain, you know, geometrical requirements

3 and so on or one could design a sampler to

4 achieve I guess a performance goal for I guess

5 some fractional recovery of particular sizes

6 without constraining the geometry of it. I

7 don't know if that's quite what you meant, but

8 maybe just laying out what those are might be

9 useful. 

10 DR. HOPKE: Well, there's two

11 issues really. One is the sins of the past

12 continue to haunt us because they fail to make

13 the performance standard for the PM10 sampler

14 sufficiently rigorous. But there's also the

15 problem now in terms of if one puts a

16 performance standard out there, will anybody

17 leap to the bait? Given the consolidation of

18 the field so that we now wind up with only two

19 companies that still actually make samplers,

20 will either of them invest in developing

21 testing and validating a sampler whereas if

22 all they have to do is follow a set of machine

Page 97

1 drillings and they're guaranteed to have a

2 valid sampler, might that then get the sampler

3 into play quicker? That's a valid question. 

4 I mean, I think, in general, it's better to

5 let the creativity of capable engineers meet

6 a design criteria because there are likely to

7 be innovations which may or may not have been

8 developed in the development of the design

9 standard. But it may be in this case, at this

10 current point in time, impractical to have a

11 performance standard. But I think there

12 should be at least some discussion of the two.

13 DR. FREY: Okay. Yes, George? 

14 MR. ALLEN: A quick note. There's

15 always the option for an FEM. You can have

16 the FRM by design and FEM by performance kind

17 of a definition.

18 DR. HOPKE: Yes, if they don't

19 make the hurdles insurmountable like they did

20 for continuous --

21 MR. ALLEN: Right. But the issue

22 is with a performance specification hurdles
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Page 98

1 are very similar to those in an FEM, about the

2 same thing. So you can have it both ways. 

3 You can have your cake and eat it, too. 

4 DR. FREY: Okay. I guess another

5 point on the cover letter bullets. The first

6 one I guess I'm a little unsure of, but I

7 wonder if this is a launch point for a broader

8 discussion that might cut across the chapters

9 on are there PM size ranges that we are more

10 interested in than others or is there some

11 differential in the health effects relevance

12 across PM size ranges that would inform a

13 discussion on this bullet point and that also

14 might, therefore, merit some discussion in

15 chapter two? And I wonder if anyone has any

16 thoughts about that? I think, you know, a few

17 people have brought this up kind of

18 tentatively yesterday, and I don't think

19 anyone took the bait on it and maybe we don't

20 know enough to take the bait on it, but I

21 wonder if there's something more that could be

22 said? 

Page 99

1 MR. ALLEN: I think it's hard to

2 say what needs to be said in a short

3 paragraph. I mean, this is a really kind of

4 a snake pit. There's different, I mean one

5 argument is do the best you can but have it be

6 robust and reproducible. Another argument is

7 we don't really care about particles greater

8 than 10 microns. I've heard that one, and we

9 really haven't had that discussion with the

10 entire panel, including the folks that are on

11 the back end with the health and the exposure

12 piece. So I don't know. If you said the

13 question if we could have what we wanted,

14 forgetting about the technical issues, what

15 would we want, I haven't heard that.

16 DR. FREY: Does anyone have a wish

17 list for what you would like in terms of

18 particle size? 

19 MR. ALLEN: Or do we care about if

20 X microns or not, you know? 

21 DR. FREY: Phil?

22 DR. HOPKE: Well, I mean,

Page 100

1 obviously, since we know the main mechanism is

2 not inhalation and, yet, you know, particle

3 mass is a cubic function of size; therefore,

4 bigger particles could potentially carry

5 substantially more lead. If that then can

6 stick to the hands, get in, even if they

7 weren't fully dissolvable in stomach acids

8 because you start off with a lot more, that

9 represents a significant potential dose that's

10 important. 

11 I mean, I think we just need to

12 have some way of connecting the dots. I mean,

13 the reason we had a TSP standard and continue

14 to talk about a TSP standard is because it's

15 not inhalation that's the primary cause of the

16 dose. And if that's the case, then we've got

17 to then come up with a metric that makes sense 

18 in terms of depositing lead in places where

19 people can get it on to hands or in other ways

20 get it ingested. And so I'm not quite sure

21 how we get to that point, but there certainly

22 has to be some of that discussion. 

Page 101

1 And then if we're going to set up

2 differential measurement tools, in one case we

3 say, oh, because we're not in source areas we

4 don't have to worry about big particles. I

5 don't fully get that, okay? Whereas, in

6 source areas I worry about big particles? I

7 mean, if my source is a combustion source, I

8 only make little particles so big particles

9 don't matter anyway. 

10 So we have a disconnect between

11 the physics and chemistry of production and

12 this measurement scenario. So we've got to at

13 least have the pieces put together in some

14 sort of logical framework. 

15 DR. FREY: Okay. Well, I think

16 that's helpful. I think I figured out what

17 was really kind of bugging me is that first

18 sentence. I think I would rather say data on

19 various PM sizes are useful not because we're

20 happy to have it because there isn't much

21 available. That is, in part, true. But I

22 think there's also a utility to it, I think,
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1 that Phil laid out pretty nicely for non2 inhalation pathways that we're maybe a little

3 bit less concerned about the particle size

4 itself or maybe, to say it a different way,

5 that the potential exposure is significant

6 across a wide range of particle sizes for non7 inhalation and that that's one of the reasons

8 why we want to look at the larger particles.

9 MR. ALLEN: Yes, we're trying to

10 sample dirt. 

11 DR. FREY: Yes, yes. Okay. Rich? 

12 MR. POIROT: And also I think this

13 would be one of the specific places where we

14 would want to seek a better connection between

15 the exposure metrics as a function of particle

16 size in chapter four. 

17 DR. FREY: Which leads to the next

18 point and, yes, I'm glad you mentioned that. 

19 We say we need a better linkage. Can we be a

20 little more specific about what it is we're

21 looking for? I know, Rich, if you can answer

22 that or other members of the, either the

Page 103

1 chapter three or the chapter four discussants

2 could elaborate a little bit. To just say we

3 need a better linkage, if I were EPA receiving

4 that, it would be kind of vague. Can we be

5 more specific what we're asking for? 

6 DR. GOODRUM: I have a suggestion

7 on chapter four to be more specific for them,

8 just as an example. If they present summary

9 information across studies, like Table 4-3

10 does, which is a comparison of personal indoor

11 and outdoor lead PM measurements from several

12 studies, that they make sure that they present

13 some summary statistics on the size fractions. 

14 That might be one place that they can start to

15 create a grouping logic that, you know, leads

16 to an understanding of air lead and blood lead

17 slope factors. Are they the same across these

18 studies that have similar distributions of

19 particles or not? So try to integrate some of

20 the, if available, particle size information

21 from those studies. 

22 DR. FREY: Okay, good. Any other

Page 104

1 suggestions there? Okay. Maybe a couple of,

2 I think these are small points. I guess,

3 Rich, you had talked about a list of key

4 sources and that those could be either high

5 emitters or maybe ones that are significant to

6 exposure, and I'm not sure I actually saw that

7 in the response to charge questions here. It

8 seems like that's something that might be

9 worth putting in here. Was it intended to be

10 here or --

11 MR. POIROT: I'm not opposed to

12 including --

13 DR. FREY: Okay. 

14 MR. POIROT: -- a list of key

15 sources, key lead sources, just a list.

16 DR. FREY: Well, I think we had

17 talked, we had some discussion yesterday and

18 then again today about some context for what

19 are the significant either -- I guess you can

20 think of it as either the source-oriented

21 exposure combinations. And so you might have

22 some high-emitting sources, maybe they're

Page 105

1 point sources. But you might have some lower2 emitting sources, like aviation, that, because

3 of their dispersion characteristics, could

4 lead to exposures to large numbers of people

5 and some discussion of that more than is

6 currently in the documents. 

7 MR. ALLEN: So it's kind of a

8 broad brush stroke picture --

9 DR. FREY: Yes, I think so. 

10 MR. ALLEN: Oh, okay, sure. That

11 makes a lot of sense. The exposure, if you

12 look under the details of all the exposures,

13 it's very complicated. But if you step back

14 a bit, it's actually, the sources are pretty

15 simple. 

16 DR. FREY: Okay. Anything else on

17 chapter three or implications of chapter three

18 for other chapters or for the chapter two

19 synthesis? I think we at least have one

20 example of how chapters three and four could

21 be more closely related.

22 MR. HANLON: Just a point of
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1 clarification on that discussion point on the

2 first page, 3.5.3, where the summary notes

3 that better use of material in the Cho paper

4 and the Cavender Schmidt paper. Rich pointed

5 out that maybe a comparison of the data would

6 be useful. Was there an agreement to suggest

7 that that comparison be done, or it was kind

8 of left open whether a comparison was

9 recommended. 

10 MR. ALLEN: The memo in the table? 

11 My understanding is that the consensus is if

12 we get the table fixed we don't need the memo.

13 MR. POIROT: And the Cho, et al.

14 was a literature-based review of comparative

15 data, whereas the Cavender Schmidt and the

16 comparison in the last draft of the ISA were

17 based on AQS data. 

18 MR. ALLEN: Right. And that goes

19 beyond the sticking with the published

20 literature piece, but I think here that's

21 probably very appropriate because part of this

22 literature is sparse on this. 

Page 107

1 DR. FREY: Okay. I propose we

2 take our 15-minute break. So we will resume

3 at 10:35 with chapter four. 

4 (Whereupon, the above-entitled

5 matter went off the record at 10:19 a.m. and

6 resumed at 10:38 a.m.)

7 DR. FREY: Okay. Let's get

8 started. We have until 12:30, and I know a

9 number of people are leaving at 12:30. I know

10 a couple of people are leaving at 12. And we

11 have chapters four, five, six, seven, and the

12 introductory chapters to talk about. So we

13 have five charge questions. We have about a

14 hundred or so minutes, so we have about 20

15 minutes per charge question. So let's into

16 chapter four. And, yes, I wanted to just

17 double check on the phone. I think we have

18 two panel members on the phone. Michael

19 Weitzman, are you on the phone? 

20 DR. WEITZMAN: Yes, I am. Hello. 

21 I apologize for not being there. 

22 DR. FREY: Well, we're glad you're

Page 108

1 with us on the phone. Please feel free to

2 interrupt if you have something you want to

3 say. And, Sean Hays, are you on the phone? 

4 DR. HAYS: Yes, I'm here.

5 DR. FREY: Okay. Excellent. 

6 Let's see. Phil, can you walk us through the

7 key points on the chapter four? 

8 DR. GOODRUM: Sure. And

9 continuing with the theme I think you set out

10 which is focusing on questions that had to do

11 with recommendations for more synthesis,

12 especially across chapters, we actually have

13 a whole section just on that one topic, so

14 that's convenient. The other two that we kind

15 of grouped our overall comments into are

16 recommendations for additional discussion and

17 perspective from EPA on some of the relevance

18 of the information that's provided and then,

19 lastly, a kind of catchall for some of the

20 contradictions that we spotted. So maybe I'll

21 just focus on the first in the interest of

22 time. 

Page 109

1 In section 4.1, there's a

2 discussion of exposure pathways. And as an

3 example, one of the subsections is on dietary

4 lead exposure, so that's 4.1.3.3. In general,

5 we felt that those short discussions about

6 pathway were good. They were factual, but

7 they still lacked some synthesis. So what is

8 the take-home message from that summary of

9 that pathway that helps to relate it back to

10 the main points of the document or at least

11 the main points in this chapter, which have to

12 do with understanding the, for example, air

13 lead/blood lead slopes. So a couple of

14 sentences maybe even that provide that

15 synthesis at the end of those sections would

16 be worthwhile.

17 Okay. There's a very good

18 presentation of the use of the IEUBK model and

19 a discussion of percent contributions of air

20 lead to blood lead, and there was a suggestion

21 to bring that information into a more readable

22 format, for example onto a table summary, that
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1 would help the reader better understand what

2 the messages are and be able to, in one

3 snapshot, kind of get a better feel for what

4 the literature supports, what the modeling

5 estimates support. So a table that includes

6 both the IEUBK-based or other model-based

7 estimates of percent contribution, along with

8 any of the information that's available from

9 the literature on that same topic, would be

10 helpful to capture. So we like the new text,

11 and it's just add a new table to help

12 synthesize the information.

13 And then, lastly, we had talked

14 about trying to understand ultimately what the

15 implication is for some of these slope factor

16 estimates on the change in the blood lead at

17 both the geometric mean and at the higher

18 percentile. So that's not yet here but could

19 be included as a way of providing some

20 perspective on the various uncertainties in

21 those estimates of those slope factors or the

22 fact that those slope factors represent

Page 111

1 different communities and, therefore, when you

2 extrapolate from those particular studies, you

3 know, that's an uncertainty. So to put into

4 context some of the uncertainties that are

5 well described already, it would be helpful to

6 have perhaps some figures, and we had some

7 examples that we can improve. And that would

8 carryover, as well, probably into at least

9 chapter two, the integrated summary, where

10 there might be some overall discussion of what

11 the air lead/blood lead slope factor

12 relationships appear to be and what the

13 uncertainties are and how that translates into

14 changes in the blood lead estimates. 

15 So those are the summary points on

16 synthesis topics. Do you want me to go

17 through any others, Chris? 

18 DR. FREY: Yes, why don't you go

19 ahead and summarize the response to charge

20 questions, and then we can open it up for

21 discussion.

22 DR. GOODRUM: We really liked

Page 112

1 figure 4-22. That was a request before. This

2 was the figure that takes the slope factor

3 estimates that were presented in text and

4 table format and shows it graphically, and we

5 thought that was extremely helpful. Our

6 suggestion is to go one step further because

7 that figure has an X axis, which is air lead

8 concentration that I think ranges from zero to

9 four, going by memory, or zero to ten

10 possibly, there's an important discussion that

11 needs to happen on the low end of the air

12 distribution, which is where all the action is

13 right now. And so recognizing that some of

14 those slope factors are generated from

15 empirical data that had higher air lead

16 concentrations and, therefore, were kind of

17 looking at the modeled estimate at the low

18 end, understanding the implications of the

19 model choices becomes even more important. So

20 that discussion of the differences in the low

21 end should be presented and then any

22 implications for model selection.

Page 113

1 We picked up on the theme of

2 measurement error that was discussed yesterday

3 and just had a suggestion for bringing that

4 back into chapter four. So where it may be

5 discussed in earlier chapters, there's an

6 opportunity here to cross reference to a

7 section where, you know, measurement error in

8 historic lead TSP measurements is noted. And

9 I think it was suggested yesterday that it's

10 likely that the air that's introduced from the

11 underestimates is minor relative to other

12 sources, and that statement alone would be

13 helpful to bring forward here.

14 And this is a comment that comes

15 from Ian's individual comments on the

16 historical perspective. He got the sense, and

17 I'll speak for you, feel free to add, Ian,

18 that chapters three and four tend to highlight

19 or focus on the relationship between trends

20 and decrease in gasoline lead and blood lead

21 at the expense of not really highlighting some

22 of the other major achievements. In
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1 reductions, for example, I would think the

2 food lead reductions in the FDA estimates of

3 exposures via diet would be another one to

4 highlight. That's been worked on quite a bit

5 and works its way into the IEUBK model in the

6 current version.

7 And then, lastly, our last

8 grouping here is the contradictions. We had

9 noted that there's an apparent contradiction

10 in some of the text compared to the figures

11 that convey the idea of the elimination rate

12 constant for blood lead, the blood lead

13 compartment. So when exposure stops, what

14 does that decline look like? The model-based

15 estimates suggest it's rapid. Some of the

16 texts suggest the opposite. So if the results

17 that we're seeing in the model are assumption

18 specific, that needs to be brought out a

19 little bit more so that it isn't such a stark

20 contrast.

21 And then, lastly, there's a couple

22 of places where one percent of the body burden

Page 115

1 is the estimate for the contribution of the

2 blood lead compartment compared to the total

3 body burden and then other places it's

4 mentioned it's five percent, so just to make

5 those consistent. Those were the highlights.

6 DR. FREY: Okay, great. Phil,

7 that's great. So, yes, for each of these, we

8 want to make sure we're answering the charge

9 question. I think, to my interpretation, this

10 is responsive to the charge question. We want

11 to deal with synthesis across chapter, and

12 Phil has alluded to this, and so I think there

13 are implications for chapter three. There are

14 things that should be folded into chapter two

15 on the relationship between monitoring

16 measurement and implications for the slopes. 

17 The key points for the letter, I

18 think maybe that's something we could discuss

19 is what really are the key things that should

20 come up to the level of the letter to the

21 administrator? And then are there things here

22 that are really critical for the next draft of

Page 116

1 the ISA, so I'll open it to some discussion. 

2 Michael? 

3 DR. KOSNETT: Yes. I thought what

4 Phil did was very good, but I wanted to, I

5 realize I wanted to add one, or suggest the

6 addition of one, additional thing to perhaps

7 2A, which is that we should ask EPA, you know,

8 doing all this, looking at the issues about

9 all the different slopes, to provide a

10 critique that ultimately identifies the slope

11 that would be most appropriate to use in this

12 assessment. And as Ian pointed out, they've

13 already used the slope in the past models, but

14 someone who's reading this, without knowing

15 which one they have used, wouldn't know. So

16 I think they should just take it another step

17 forward in saying, okay, we have these

18 different slopes, this is their fidelity to

19 the empiric data, like you've said, but just

20 another sentence in that saying, based on a

21 critical analysis of these issues, identify

22 the values which are most scientifically

Page 117

1 justified for risk assessment or for one they

2 should look and do a sensitivity and look at

3 a range of ones.

4 DR. GOODRUM: I guess my reaction

5 to that is do we, as a science body here,

6 really want to recommend that EPA isolate one

7 of the slope estimates as being the best,

8 understanding that maybe they have already. 

9 If they have and that was in there, I'm not

10 sure I'd be comfortable with that without

11 really understanding the basis for that

12 selection. So I wouldn't want our comment to

13 give the impression that we're just asking the

14 EPA to document a slope factor that is among

15 the table. It would really need some solid

16 discussion and rationale for why. 

17 DR. KOSNETT: I think, ultimately,

18 I think they might say that, historically, in

19 the historical development of air quality

20 standard, in the last revision they used this,

21 and that whether they still believe that is

22 the best to use and decide to justify it
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1 scientifically. 

2 DR. GOODRUM: I guess why I'm

3 uncomfortable with it is I'm not sure that I

4 agree that a single slope factor is

5 appropriate in this context. 

6 DR. KOSNETT: And I'm not

7 disagreeing with that.

8 DR. GOODRUM: I know you're not. 

9 I know you're not. That's why I'm

10 uncomfortable.

11 DR. FREY: It would seem like for

12 the integrated science assessment it would be

13 appropriate for a critique and maybe some

14 discussion of things like the central tendency

15 or range of plausible slope factors where the

16 evidence is stronger or the study was

17 conducted more rigorously or whatever the case

18 may be. I think in the REA, which will be

19 part of the policy assessment, the ISA should,

20 I think, provide a foundation that when the

21 choices are made in the REA it could be

22 referenced to the ISA that, well, this slope

Page 119

1 was chosen as the best estimate, to the extent

2 there's an uncertainty analysis, whether it's

3 qualitative or quantitative, it could refer

4 back to information given in the ISA. So I

5 don't know that the ISA actually needs to be

6 so definitive on saying this is the -- unless

7 there really is, I think, a strong case for

8 that. 

9 DR. KOSNETT: Yes, I'm fine with

10 that. The concern I had is, you know, they

11 say, well, here's a table and they have

12 different values. But then I was thinking,

13 well, which do you like and which do you don't

14 like for various reasons? I just think that

15 I would encourage them to take that next step. 

16 DR. GOODRUM: Yes, I hear what

17 you're saying. If they already have kind of

18 considered that, it would be good to document

19 their thinking process. 

20 DR. FREY: Okay. We have some

21 other panelists. Dr. Von Lindern and then Dr.

22 Pounds. Did I miss anyone? And Rich Poirot.

Page 120

1 DR. VON LINDERN: Well, I think

2 you came to the same conclusion I was

3 suggesting. The agency already has in both

4 promulgations in the 70s and again last year

5 picked a slope. It's just a matter of

6 reporting that. They really don't have to say

7 if it's the best one again or not, but they

8 have used one. I think that would be valuable

9 information.

10 I just had one other comment that

11 goes back to Dr. Hopke's earlier description

12 of the importance of particle size. That

13 should probably be repeated in this chapter,

14 and my own opinion is every particle size is

15 important because the smallest ones are,

16 there's those that stay in the lungs, there's

17 those that catch in the mucous and go into the

18 gut, there's those that come back out and land

19 in the dust and they're picked up on the

20 hands, and those that aren't picked up on the

21 hands stay in the soil waiting for a chance to

22 get them later. So that's why we look at TSP,

Page 121

1 and that's important, but that's the exposure

2 that we're trying to cover and that should be

3 in this chapter, I think, as well as in

4 chapter three. 

5 DR. FREY: Okay. So, Phil, I

6 assume you're making notes on -- okay. Joel? 

7 DR. POUNDS: I suggest that we

8 carry the comments on consistency or apparent

9 contradictions up to the level of the

10 document. So the EPA has nicely improved the

11 cross references from one chapter to another,

12 and, as I looked at -- so we have the same, in

13 some instances, the same papers being reviewed

14 for different purposes in different chapters

15 by different authors. And I think that

16 whenever there's a cross reference for

17 important numbers, they should have someone

18 look at those to make sure that the message

19 and the data and the interpretation is

20 consistent. We found cases within chapter

21 four, in between chapter four and chapter five

22 which were not consistent or were somewhat
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1 muddled.

2 MR. POIROT: Well, I was just

3 thinking that on item 2B, you talk about

4 comment on the importance of measurement

5 errors associated with historical lead TSP

6 measurements, the measurement errors relate to

7 the extent to which larger particles have been

8 excluded by the TSP methodology. We're

9 talking about, almost exclusively, particles

10 with greater than ten and on up, throughout as

11 large as you want to count them. But whatever

12 those errors were historically, they're

13 possibly as likely to be as large or probably

14 larger now if that's the kind of error you're

15 talking about because, historically, the lead

16 air concentrations were more dominated by the

17 gasoline combustion and fine particle lead

18 data. So my suggestion would be to just

19 reword that and, instead of talking about

20 measurement errors, refer to it as the

21 particle size characteristics of current and

22 historical TSP measurements, which I think

Page 123

1 captures the same point. 

2 DR. FREY: Okay, good. Any other

3 comments? We have a minute and 30 seconds

4 left on this charge question. Okay. I don't

5 know. Phil, do you want to try to offer any

6 thoughts on what are the most important points

7 for the letter? And this can be -- we don't

8 have to have a final answer today.

9 DR. GOODRUM: I think probably

10 focusing on the theme of needing more

11 synthesis, and then we can provide some

12 examples of that in the letter. But if we

13 have to boil it down to one paragraph for this

14 particular chapter, it would be, you know, our

15 suggestions to better synthesize the data. 

16 DR. FREY: Okay. All right. 

17 Well, in the interest of time, let's go on to

18 chapter five. And, Susan, could you guide us

19 through?

20 DR. KORRICK: Yes, sure. So I was

21 trying to sort of pick what I thought were

22 highlights of people's comments in yesterday's

Page 124

1 discussion, so I apologize to others if I've

2 left out something that you think is a

3 priority, and I'm sure there are other things

4 we could add. But in sort of the big picture

5 sense, I wanted to first, up-front,

6 acknowledge areas where we thought chapter

7 five was improved, and I know there was some

8 disagreement about the group, so you all

9 should let me know if you feel this is a

10 reasonable consensus representation. 

11 There were improvements in terms

12 of integration between epidemiology and

13 toxicology literature. There was improvements

14 in terms of adding a section in the nervous

15 system effects outcome regarding public health

16 significance, which was a helpful and

17 informative section. And there was good

18 consistency in acknowledging that contemporary

19 blood lead levels in adults and older children

20 do not necessarily account for observed health

21 effects because of past likely higher

22 exposures.

Page 125

1 So those were kind of the areas

2 where I think most of us were in agreement

3 about the improvements that have been made

4 between drafts. And then I think that, in

5 addition, for some health outcomes,

6 particularly childhood IQ, adult nervous

7 system effects, blood pressure, and

8 cardiovascular outcomes in general, the

9 critical analysis of the literature and

10 assessment of causality was done well. Again,

11 this is an area where I want to make sure

12 everybody feels that's a reasonable consensus

13 statement. 

14 But for a number of other key

15 health outcomes, there were limitations that

16 we were concerned about. And so I just tried

17 to come up with a relatively short list

18 summarizing some of the key limitations,

19 realizing that there were a lot more specifics

20 that we talked about as a group. Again,

21 anyone who wants to add to how to prioritize

22 this, that would be great.
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1 So I think some of the more

2 fundamental ones were that the critical

3 assessment of each study reviewed for a given

4 health outcome was not done in a very measured

5 or transparent way. There was not a

6 consistent approach to looking at each study

7 and determining whether results were credible

8 based on design or concerns about residual

9 confounding, and there wasn't a good system

10 for distinguishing among studies in terms of

11 their likely robustness.

12 There was also a related lack of

13 transparency regarding causal determination. 

14 So, again, there was not, for a number of

15 health outcomes, a very balanced analysis of

16 the strengths and weaknesses of the literature

17 that contributed to conclusions and then the

18 nature of how those conclusions were drawn

19 using sort of causal determination criteria

20 which are nicely outlined in the preface to

21 the document. So there's no explicit

22 description of application of those criteria

Page 127

1 to causal determination.

2 And then I think some of the more

3 specific areas that seem to come up repeatedly

4 yesterday and in people's comments were lack

5 of clarity in both describing terminology and

6 also the conceptualization or understanding of

7 behavioral outcomes. And this was

8 particularly true with sort of confusion

9 between formal psychometric tests of attention

10 versus clinical ADHD and also true in terms of

11 trying to establish homologies between animal

12 testing protocols and human behavioral tests

13 where, in some cases, the homologies were

14 appropriate and others they weren't.

15 And then I think we didn't talk

16 about this a lot, but I think there was, in an

17 effort to be more circumspect about the role

18 of blood lead in determining health effects in

19 adults and older children, I think some of the

20 clarity regarding exposure levels at which

21 observed effects were likely to occur got lost

22 in this draft. And then I think there was an

Page 128

1 overall appearance, which came up a couple of

2 times either in written or spoken comments, of

3 sort of a confirmation bias in the document,

4 if you will, where studies of associations

5 were not mentioned, and notable among these

6 included studies that Gail Wasserman and Rich

7 Canfield have done looking at attentional and

8 behavioral problems in kids and childhood lead

9 levels. 

10 So then I sort of skipped, but

11 some examples of some of these limitations

12 were that, in particular we talked a lot about

13 the strength of the literature with childhood

14 cognition versus childhood behavior are

15 treated in the document as if they're

16 comparable, but I think the consensus is

17 that's not the case and that the text needs to

18 do a more critical review of the childhood

19 behavioral literature and a more tempered

20 conclusion would result from that. And,

21 similarly, for the review of renal outcomes,

22 the review was not balanced in terms of

Page 129

1 identifying a number of key uncertainties in

2 our understanding of the relation of lead with

3 renal outcomes, and I've listed some of those.

4 So I think those are what I sort

5 of identified as sort of major themes, but,

6 again, I realize I've not talked about

7 everything we went over yesterday. So I

8 welcome input. 

9 DR. FREY: Yes, that was a nice

10 summary. I guess, looking at the charge

11 question, one is, the very beginning is

12 comment on the extent to which the revised

13 discussion of the evidence and the causal

14 determinations accurately reflect the weight

15 of evidence. And I realize there were a

16 number of concerns about the transparency of

17 the determinations, but I wonder are there any

18 fundamental disagreements with the conclusions

19 reached as far as weight of evidence or

20 causality and are those sufficiently reflected

21 in the response? 

22 DR. KORRICK: Yes. I mean, I
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1 think that's a fair comment. I didn't

2 organize these very well for looking at the

3 specific charge questions, but I think that

4 the short answer is that for some of the key

5 health outcomes the discussion of the evidence

6 and causal determination was not adequate. 

7 And those specific outcomes include behavior

8 and renal effects, and I think, to some

9 extent, in the immunology section, which we

10 didn't talk about as much yesterday. So I can

11 sort of reconfigure this a little bit to be

12 more explicit about that.

13 DR. FREY: Yes. And I guess is an

14 implication of what you just said that because

15 the discussion wasn't transparent enough there

16 isn't actually sufficient information to

17 determine whether the conclusions accurately

18 reflect the weight of evidence, or is it

19 possible to comment on whether EPA's

20 conclusions about causality weight of evidence

21 were reasonable given the knowledge basis in

22 the literature?

Page 131

1 DR. KORRICK: Yes. I mean, I

2 think it's a little bit of both, so I think

3 sometimes they came to the wrong conclusion

4 because they didn't look at things in a

5 measured, balanced way. And sometimes they

6 may have come to the right conclusion, but

7 it's not clear how they got there. But, I

8 mean, I think the more egregious oversight is

9 to have come to the wrong conclusion and,

10 based on the panel's understanding of the

11 literature, the wrong conclusion without us

12 knowing why they came to that conclusion. 

13 DR. FREY: Okay. I know, Michael,

14 you want to say something and then Rick.

15 DR. KOSNETT: I think a key

16 concern is that a lot of times the way that

17 the causal determination is expressed is

18 ambiguous. You know, like statements like the

19 weight of the evidence strongly supports the

20 association. Is it a causal association or

21 not? Just epidemiology doesn't necessarily

22 provide an answer with respect to causation

Page 132

1 just because there's a strong association. 

2 There's confounding, and if it doesn't have

3 biological plausibility or if there's

4 inconsistent findings. 

5 So I think, in what I wrote in the

6 beginning for the comments on chapter two on

7 the first bullet really speaks to this in a

8 similar way on page two. I think it really

9 applies to five because it's -- so I think, I

10 don't know, you know, there's going to

11 definitely be overlap, Chris, between the

12 comments in two -- the comments on chapter two

13 and the comments on chapter, all the chapters. 

14 But this particularly speaks to chapter five.

15 DR. FREY: Oh, yes, absolutely. 

16 Well, I guess what I'm getting at is in the

17 response to the charge questions for chapter

18 five, to the extent that we as a panel don't

19 feel we're able to comment on whether EPA

20 reached the right conclusion because of the

21 lack of transparency, I guess it could be

22 possible that, as EPA goes through that

Page 133

1 process of reviewing the literature in a more

2 systematic way as outlined in the chapter two

3 comment and also as alluded to here, that

4 maybe they might reach different conclusions

5 than they currently have. I just wonder to

6 what extent we want to or should address that

7 in the chapter five response to the charge

8 question. 

9 DR. KOSNETT: Well, you raise

10 another key point is that should we weigh in

11 based on our reading and our knowledge of what

12 is out there about what we think with respect

13 to all these end points and a causal

14 determination? I mean, I would be prepared to

15 do that. Do you want me to discuss that now

16 further? 

17 DR. FREY: We don't have time for

18 a detailed discussion. I guess if it's a

19 consensus. Part of the challenge is that if

20 we were to go that direction we really should

21 discuss it in the public as a panel. But

22 maybe the more general point that we just
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1 alluded to that, given the lack of clarity, it

2 is possible that different determinations

3 could be reached after a revision of the ISA

4 and that, in a sense, giving EPA the latitude

5 to come to more appropriate determinations

6 after they've looked at the literature is what

7 I'm thinking is what we could say here. 

8 DR. KOSNETT: How about if we said

9 this? I think that we agree, in line with

10 what we've said the last time and here, that

11 we believe that a causal determination, a

12 positive causal determination can be made for

13 low-level lead exposure and cognitive

14 decrements in children.

15 And I think that, if anyone

16 disagrees, we think that there is a positive

17 causal determination for lead and hypertension

18 and adverse cardiovascular effects, although

19 the lower end of the dose for which that's

20 associated can't yet be determined because the

21 studies that have demonstrated it have been

22 done in people who are getting heart disease

Page 135

1 and things, which are older people whose blood

2 lead was generally in the range of 10 to 25. 

3 So we think that long-term chronic exposure in

4 the range of 10 to 25 is sufficient to cause

5 high blood pressure and cardiovascular end

6 points. It's possible it could be at lower

7 levels, but we don't know yet. 

8 And, personally, and I don't know

9 if anyone disagrees, but for the other end

10 points, behavioral effects, and, you know, the

11 evidence is less mature for the other end

12 points. And I don't know --

13 DR. FREY: Right, which we did

14 talk about yesterday, and I --

15 DR. KOSNETT: Does anyone feel

16 strongly about --

17 DR. FREY: Well, let me do this --

18 DR. KOSNETT: -- or does anyone

19 feel differently from what I'm saying? 

20 DR. FREY: Yes. I think we did

21 discuss that yesterday. Let me, I know Rick

22 is patiently waiting, and then Deborah, and

Page 136

1 then Gail. 

2 DR. CANFIELD: So I'm in general

3 agreement with what Michael is saying. But I

4 wanted to make a point about the lack of

5 transparency and the evaluation of the

6 evidence, which is that the causal

7 determination sort of framework that's laid

8 out in the preamble is quite reasonable, and

9 much of the problem in chapter five is that

10 it's not consistently applied in every

11 section. And I have the sense that EPA knows

12 that, you know, there's still work to do. 

13 There's places where the sections

14 that are really well done and clearly follow

15 the framework, and that's helpful. And I

16 think in some cases the statement of an

17 association is not intended to be the sole

18 evidence for causal determination but, rather,

19 it's along the way. That's just one piece of

20 it, and then they're moving on to mechanism

21 and et cetera. But that can get lost if it's

22 not as explicit. Obviously, it's not getting

Page 137

1 through all the time. 

2 With respect to whether the

3 conclusions are -- whether I would agree with

4 the conclusions overall, at the macro level,

5 if you look at the areas in the table, I would

6 probably move a few things from causal to

7 likely causal. That's sort of where I'm at. 

8 And the basis for that is that there are a

9 number of areas in the text where there might

10 be a decision that's not well articulated or

11 something. For example, with the Bailey

12 scores. Does that add evidence or not? I

13 think it maybe doesn't, but that's a long

14 complicated thing that will be in individual

15 comments about that. So, anyway, so that's

16 where I'm at.

17 DR. FREY: Great. Deborah? 

18 DR. CORY-SLECHTA: Well, I wanted

19 to follow up on the behavior and the

20 attention. Rick and I talked a little bit

21 about this yesterday. So, in a way, it's

22 covered in a very superficial way as part of
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1 the problem.

2 So I would say that, from my point

3 of view, there may be and I think there are

4 effects on attention-related behavior. But

5 apples are being compared to oranges. We

6 don't know what domains of attention. I think

7 the document needs some expertise in attention

8 deficit, an introduction of, you know, this is

9 a construct that includes the following, and

10 some real explicit comparisons of measures of

11 the same behavioral function. Were they, in

12 fact, comparable? Are they not? And that's

13 not in there. We can't call attention a

14 single thing. That's part of the problem.

15 So I would say, in contrast to

16 Michael saying, well, maybe the evidence is,

17 you know, less compelling, I'm not sure I even

18 know. And maybe when they do this analysis,

19 we'll find out. I mean, there have been

20 studies published saying impulsivity is more

21 affected than sustained attention. Maybe

22 we'll actually find that out, which would be

Page 139

1 an important from an intervention point of

2 view for sure. So I think they really need

3 some serious expertise in attention to go

4 through those data sets and present that

5 information. 

6 DR. FREY: Okay. Well, Gail and

7 then Michael.

8 DR. WASSERMAN: I agree with what

9 Deb said, absolutely, that we need to better

10 characterize what we're talking about. It's

11 really impossible, even for someone who's

12 reasonably familiar with the literature, to

13 evaluate based on what's there, so you'd like

14 to see the pulleys and levers underneath the

15 decisions and some construct definition.

16 This is a disorder, it's based

17 upon these three pieces of information, this

18 is how we measure it, because I think this is

19 really very important. There's a lot of

20 individual and policy related decisions that

21 are going to follow from that piece in

22 particular about services for kids, so we

Page 140

1 really need to do it carefully and well. 

2 DR. FREY: Okay. Michael? 

3 DR. KOSNETT: Yes. And I don't

4 know if we should say that, I mean, Susan, we

5 can work on the wording of this, but, you

6 know, when you say like a balanced approach of

7 the strength and the weaknesses, part of that

8 includes the fact that some of the studies are

9 inconsistent where, perhaps, I think sometimes

10 EPA, the author in that section said the

11 studies consistently show this, you know. And

12 really we would take issue with that. They

13 don't consistently show that. So that kind of

14 stuff. 

15 DR. FREY: I guess as a general

16 comment for especially chapter five, I expect

17 that, since we had a lot of discussion on

18 chapter five yesterday and it seems like this

19 is really the kind of sort of lightning rod

20 for the need for seeing another version of the

21 ISA, that I would not be surprised and I would

22 expect that the response to the chapter five

Page 141

1 charge questions might be more lengthy than

2 for the other chapters and that would be

3 appropriate. So don't feel that it needs to

4 be constrained to one or two pages. I mean,

5 if you find that you need four or five pages,

6 six pages, you know, it is what it is. Rick? 

7 DR. CANFIELD: So along those

8 lines, I've been trying to decide how best to

9 get the feedback on the table for the revision

10 because there is expertise that's needed and

11 my document of individual comments is running

12 many, many pages, and they're important and

13 it's extremely complicated because, you know,

14 tiny little changes in one aspect of a study

15 means that they're measuring something else,

16 even though it looks like they're measuring

17 the same thing, or some authors may call

18 something attention and they're talking about

19 one type of attention and another calls it

20 attention -- so that takes a lot of work. 

21 So the question is does the

22 expertise that, in a sense, I'm hoping to help
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1 provide in my individual comments, is that the

2 only way of adding some specialty knowledge in

3 some of these areas to the revision of the

4 document or are there outside sources that EPA

5 can consult? I didn't see, for example, 

6 clinical psychologist on the list of

7 contributors, and I think Debbie and I didn't

8 see an animal person. Those perspectives from

9 those sub-disciplines could be helpful in a

10 more general sense in understanding the

11 nuances of the data. 

12 DR. FREY: Okay. Well, I'll give

13 you my thoughts, and then Vanessa might, since

14 she's more experienced across many panels, may

15 be able to add to this.

16 But I think, you know, it's often

17 the case that, in responding to a charge

18 question, there's more detail in an individual

19 member's comment that is really critical to

20 that response and, at the same time, we don't

21 want to have a 50-page response to the charge

22 question.

Page 143

1 So in practice, you know, I think

2 there are many examples where the charge

3 question does refer to, you know, for more

4 details see the individual comments of, you

5 know, Dr. Canfield. It would be good, though,

6 to highlight, you know, I think what you're

7 saying, for example, is the definitions are

8 important and the methods for doing

9 measurements are important and so on.

10 So just kind of a high-level

11 summary of what it is that's in those

12 comments, a high-level summary in the charge

13 question comment of what's in the individual

14 member comment so that it really is clear that

15 that provides a lot of value added. 

16 And we talked yesterday about we

17 always have this discussion about when EPA

18 makes a revision what do they tell us about

19 what they revised, and, of course, we want

20 them to ideally give us a response how they

21 responded to the charge question. And I did

22 mention yesterday, you know, I mentioned to

Page 144

1 Dr. Vandenberg, of course, if that charge

2 question refers to an individual member's

3 comment, we're also interested in how they

4 dealt with that information. So that's my

5 perspective on it. 

6 I think on the second point, as

7 far as should EPA engage other experts in

8 revising the ISA, I'm not sure that, and this

9 is where I might ask Vanessa for her input, I

10 don't know how far we go as a CASAC in saying

11 that. I think it certainly would be

12 legitimate to say that, in this area, you

13 know, that depends on disciplinary expertise

14 in these areas and that seems to be absent

15 from the ISA and that should be incorporated

16 and then probably leave it to EPA as to how

17 they're going to engage that expertise. 

18 But, Vanessa, do you want to add

19 anything? 

20 DR. VU: Well, first, I agree with

21 you, Chris, in terms of your guidance to the

22 panel how you reference your consensus

Page 145

1 response since they refer to see more detailed

2 comments from the panelists. With regard to

3 expertise needs, you know, CASAC could always

4 say that the ISA should be benefit from

5 additional expertise in these areas and it's

6 how the agency is going to get those expertise

7 as the agency's discretion because the point

8 you're trying to make was the different

9 experts needed to define these different areas

10 of behavior and ADHD. So those are the points

11 you made, and so you're just highlighting the

12 letter. 

13 DR. FREY: Okay. Gail and then

14 Susan. 

15 DR. WASSERMAN: But I think we

16 would ask for some more guidance in the level

17 of detail we provide. I mean, I could write

18 three pages on the definition of ADHD and what

19 I know about how we assess it. And I'm not

20 sure this is the right way to do it or if

21 that's a waste of my time.

22 I mean, I don't know if I should
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1 be bulleting this is a problem, this is a

2 problem, this is a problem, or whether I

3 should be providing the answers to the problem

4 or whether you're going to go find that in

5 some other route. So if you could just give

6 us some guidance about how much help you want

7 on these things, that would save me from being

8 redundant. 

9 DR. FREY: Well, at one level, I

10 think, to the extent that this has already

11 been written in other references, then I think

12 it would be legitimate to say EPA should

13 review the definition in Smith et al. or

14 whatever. If you feel like that's not there

15 and that this is really a synthesis that isn't

16 in the literature and you're so compelled and

17 motivated and willing to write it up, I think

18 that's great. I think if you're getting to a

19 three-page definition, for example, that that

20 probably should be in the individual member

21 comments and then in the charge question to

22 say there are many nuances to this definition

Page 147

1 and as further developed in Dr. Wasserman's

2 individual response.

3 So I think if things are getting

4 to be lengthy that I would sort of think of

5 them more like an appendix, in which case that

6 could be in the individual member comments,

7 and try to keep the response to the charge

8 question brief but, you know, if it needs to

9 be several pages then that's fine. But if

10 it's getting bogged down on a detail, not that

11 it's not a critically important detail, but

12 that could go in the individual. That would

13 be my suggestion. But, of course, it's a

14 matter of judgment.

15 Do you want to add anything,

16 Vanessa? 

17 DR. VU: Well, you've been asked

18 to provide review comments on the draft ISA,

19 so if you highlight key points that the agency

20 needs to further differentiate different terms

21 and how the different experts define whatever,

22 as Chris said, if you can provide references

Page 148

1 or you can provide some general guidance,

2 that's fine. But you're not doing the work

3 for EPA. That's all I'm asking you. 

4 DR. FREY: Okay. Anything else on

5 chapter five? We went a little long on that,

6 but I think probably for good reasons. We can

7 come back and, as we go through the other

8 chapters, you know, we want to also do

9 synthesis.

10 I guess maybe I'll just throw this

11 out. Are there synthesis implications here

12 for other chapters? So how does chapter five

13 interact with chapter seven, chapter six,

14 chapter four, chapter three? And then,

15 clearly, that would fold into chapter two. 

16 Does anyone have any burning thoughts on that? 

17 And if not, we can come back to that when we

18 talk about chapter two.

19 Let's go on then to chapter six,

20 and, Dr. Cory-Slechta, if you could guide us

21 through that. And if we could have chapter

22 six on the screen, that would be great. And

Page 149

1 while we're doing that, let me just pause and

2 see if any of the panelists on the phone, is

3 there anything you want to add that you

4 haven't had a chance to, either Michael or

5 Sean?

6 DR. WEITZMAN: No, not at the

7 moment. Thank you. 

8 DR. HAYS: Likewise, no comments.

9 DR. FREY: Okay, great. All

10 right.

11 DR. CORY-SLECHTA: Okay. The two

12 charge questions are up there: commenting on

13 the adequacy of the revisions to clarify the

14 consideration of potential at-risk

15 populations, recommend any revisions to

16 improve those, and comment on whether the

17 designation of some factors as having limited

18 evidence adequately reflects the knowledge

19 base.

20 As I've listed in the first two

21 bullets, I think, in general, the group felt

22 that the revision certainly better captures
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1 the intricacies associated with at-risk

2 populations and that the reorganization of the

3 chapter in to related factors also made it

4 more cohesive and better integrated and the

5 fact that some factors were defined as having

6 limited evidence to support them in terms of

7 the strength of available evidence was also

8 adequate, so that explicitly relates to the

9 charge questions.

10 We did mention, and we got a

11 little bit into some other chapters as we went

12 through this discussion, some issues which we

13 said were still remaining and were brought up

14 by a couple of us. One was understanding, if

15 you will, the magnitude of the impacts of

16 these different risk factors. Right now, it's

17 very difficult to get any sense of whether

18 some are much more potent than others, which

19 we felt were important for risk assessment

20 policy, et cetera. 

21 There were comments here, at least

22 in chapter five and in individual comments,

Page 151

1 about comparing maternal self esteem directly

2 to stress imposed in rat models. And what I

3 included in there was that if you have that

4 kind of homology it should be limited or at

5 least qualified in terms of how you present

6 it. There were concerns about interpretation

7 of one particular study, which I mentioned. 

8 And the other issue that came up

9 was the fluoride co-exposure with lead, and

10 Rick did send out an abstract that was

11 published. And so I've simply made the

12 comment there that if, in fact, there is this

13 important interaction, which was mentioned in

14 chapter two but never addressed in chapter

15 six, it should be in both. 

16 So I didn't get -- I got some

17 comments back from Gail last night, but I

18 think other people didn't have a chance. So

19 if they have comments, now would be a good

20 time. But that was what I picked up from our

21 discussion. 

22 DR. FREY: Okay. I just wanted to

Page 152

1 clarify the text at the bottom of page ten and

2 on to page 11, that is the abstract of that

3 paper. 

4 DR. CORY-SLECHTA: Yes. That's

5 just the abstract which I forwarded to make

6 sure people could see it. It doesn't,

7 obviously, need to be in there.

8 DR. FREY: Right. Okay, good. 

9 Yes, Michael? 

10 DR. KOSNETT: With respect to that

11 fluoridation issue, you know, I have not yet

12 read this article. I think we need to be

13 careful, maybe even asking -- I don't know if

14 it's a good quality article, and so I don't

15 even know if -- I don't necessarily think what

16 we want to do is say, yes, you should keep

17 that sentence and add the sentence in chapter

18 two. I don't think you mean this but --

19 DR. CORY-SLECHTA: I think what I

20 meant, and I can revise the wording, was that

21 they should look at it and come to some

22 conclusion. That's what I'm saying. I didn't

Page 153

1 read it either, and I'm not going to make a

2 judgment on it one way or another. I think

3 it's their role to do that. So there's the

4 inconsistency between chapter two and chapter

5 six, and I think they need to come to some

6 deliberation on it.

7 DR. KOSNETT: See, I think we all

8 agree that there was a very provocative

9 statement in chapter two that fluoridation can

10 lead to elevated blood lead concentrations or

11 blood lead exposure in children. That's an

12 incredibly provocative statement. That would

13 be on the news, I'm serious, if that gets in

14 this document, if that's EPA's position. Even

15 if they think it -- any credence they give it

16 will get picked up on.

17 I don't even know that we should

18 go there unless there's a good scientific

19 basis for it, so I basically said you only

20 cited one in vitro study up until now, so take

21 it out because that one in vitro study about

22 how much lead leaches out of brass faucets in
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1 a beaker of water is not adequate to say that

2 lead fluoridation causes lead from pipes. 

3 So I would, I felt that the whole

4 issue, and I haven't reviewed it in detail,

5 but I know other people who have and I've

6 spoken to and they don't feel that the

7 evidence currently would suggest that in a

8 document like this on lead exposure that

9 fluoridation be even highlighted as a risk. 

10 I think that's so preliminary. 

11 DR. FREY: Okay. I saw a bunch of

12 hands go up, and I don't know the order. But

13 Deborah and then Phil and then Michael.

14 DR. CORY-SLECHTA: I disagree with

15 taking it out. This is in vivo data in

16 humans, and I think are you just going to

17 ignore it? I think people need to look at it

18 and come to some kind of conclusion. I don't

19 think that ignoring it is the way to go, and

20 I think that's what you're suggesting

21 essentially. You've already assumed that this

22 is a bad paper, that these findings aren't

Page 155

1 relevant, and I don't think it's correct

2 necessarily to do that. I think it's up to

3 them to look at it --

4 DR. HOPKE: You need somebody with

5 some good chemical background reading that

6 paper. There are some issues. 

7 DR. CORY-SLECHTA: And some human

8 studies and human expertise.

9 DR. KOSNETT: All right. Fair

10 enough, Debbie. I haven't read it, so it's

11 not fair for me to say not to include it. But

12 I am -- I'll read it and I'll tell you what I

13 think. Maybe we'll comment on it. But I'm

14 just saying it's such a controversial and hot

15 button area that, before it's highlighted, a

16 lot of care should be given to it. 

17 DR. CORY-SLECHTA: Right. I'm not

18 saying to highlight it. I'm saying they

19 should look at it and maybe they come to the

20 conclusion that, you know, it isn't

21 sufficiently compelling to come to that

22 conclusion. But they need to acknowledge that

Page 156

1 it's out there for sure.

2 DR. KOSNETT: It may just be this

3 one article, right? 

4 DR. FREY: I think, if I

5 understand the discussion, in chapter six it

6 seems appropriate to cite this and to have

7 some critique of it. And I guess it's not so

8 clear right now if the weight of evidence

9 related to this is strong enough that it

10 really merits being in chapter two. And so I

11 think that's the question. 

12 DR. KOSNETT: Okay.

13 DR. FREY: And I think, I'm not an

14 expert on lead and drinking water, but I kind

15 of asked my colleague, you know, does

16 fluoridation enhance leaching of lead in

17 drinking water, and he came back with a very

18 limited answer. So my sense is, I'm not an

19 expert, I don't know that this is a big area

20 within the drinking water community. But I

21 think in revising the ISA, EPA could look to

22 see if they find more related to this or if

Page 157

1 this is supportable or, as Phil alludes to,

2 maybe there's some issues with the chemistry

3 here in terms of the exposure aspects.

4 Okay. Michael? Did I miss

5 somebody? I'm sorry. Was someone else

6 waiting? Michael, go ahead. 

7 DR. RABINOWITZ: Dr. Pounds and I

8 were kicking this around a little bit, and I'm

9 told that it may not be just a matter of the

10 fluoride increasing plumbosolvency of the

11 plumbing system. It could be that it's

12 mediated through the bones. That is to say --

13 well, let me ask a question. Do people with

14 fluorosis have higher or lower blood lead

15 levels than people with fluorosis? Adults,

16 children, whatever.

17 It could be that the fluoride

18 strips the lead or prevents the lead from

19 going into the bone, so it could be something

20 internal rather than exposure mediated. I

21 don't know, but there is a lot of literature

22 out there about fluorosis and blood lead
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1 levels. I haven't had a chance to look at it,

2 but there's a fair amount of literature on it.

3 DR. FREY: Well, it seems like

4 that might be a good point to raise for EPA to

5 consider in their revision. Phil, did I skip

6 you? Did you have your hand up?

7 DR. GOODRUM: My point is already

8 made. 

9 DR. FREY: Oh, okay, all right. 

10 Good. Any other discussion on chapter six? 

11 Yes, Rick? 

12 DR. CANFIELD: This is a little

13 bit nuanced, but it relates to this issue of

14 homology and self esteem, et cetera. And I

15 just want to try this out with my colleagues

16 here and see if this works for them, which is

17 a typical model for maternal stress in an

18 animal model is restraint stress. And in many

19 models, you would tie restraint stress to

20 learned helplessness and learned helplessness

21 to lower sense of self efficacy and correlated

22 self esteem.

Page 159

1 So what I tried to do there is

2 make a homology from the restraint of an

3 animal and learned helplessness outcomes based

4 on learning theory, etcetera, and then the

5 notion of a maternal self esteem being related

6 to a lack of self efficacy, which is often

7 found in low income situations.

8 Anyway, so I wanted to try that

9 out because this is where the rubber meets the

10 road on all of our issues with respect to

11 these specific questions. So it's out there. 

12 DR. CORY-SLECHTA: You know, I can

13 see those kinds of logic deliberations. They

14 get a little bit far removed. I personally

15 would like to see the actual self esteem

16 measurement because, yes, you can, in fact,

17 have stressors and, in fact, in female

18 offspring they typically do lead to

19 essentially those kinds of outcomes, even in

20 rodent models of anxiety, depression, et

21 cetera.

22 So it would be interesting to see

Page 160

1 the actual questionnaire and what was actually

2 being measured. It gets into a very

3 complicated business, though, because stress

4 is not stress. So some stress is good, and

5 other stress isn't, and that's where it does

6 get very nuanced. So I think it could be

7 qualified to reflect the possibilities, but,

8 obviously, there's a long way to go at this

9 point. 

10 DR. FREY: I don't know who had

11 their hand up first. I'm going to say Susan

12 and then Gail and hope I'm right. 

13 DR. KORRICK: Just one, hopefully

14 brief comment. I think this is kind of

15 another example analogous in my mind to the

16 issue of how attentional outcomes are being

17 assessed because I think this is an area that

18 requires a level of expertise that may or may

19 not be currently used for this document, and

20 I suspect that self esteem was Pam Surkan's

21 paper; is that right? Yes.

22 So, you know, my guess is, and I

Page 161

1 haven't looked at that paper in a long time,

2 this is a really challenging area to review

3 the literature in because authors oftentimes

4 muddle these concepts. I mean, and I don't

5 mean this disrespectfully, but it's just

6 complicated.

7 So stress is probably overused a

8 lot in the epi literature to categorize all

9 sorts of measures. Similarly, ADHD is used

10 too much. And so I think the bottom line is

11 I think this is another area where to really

12 do the kind of subtle, nuanced assessment, a

13 level of expertise that is difficult to come

14 by may be needed. And I think that's a

15 challenge. That's all. 

16 DR. WASSERMAN: I think that

17 stress is not always restraint stress. 

18 Sometimes it's like food deprivation. I mean,

19 these are very global things with animals. 

20 They're also often very global with humans. 

21 And just to lay out what exactly, you know, if

22 it's a duck, if it walks like a duck. I'm
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1 back to that. Just say what it is, rather

2 than perhaps defaulting to the overarching

3 construct because when we do that too quickly

4 we may miss the nuance.

5 DR. FREY: Okay, good. So,

6 Deborah, will you incorporate this discussion? 

7 Excellent. Well, I think we're at a good

8 point to move to chapter seven, and also time9 wise we're at a good point to move to chapter

10 seven. So, Roman, could you guide us through

11 that? 

12 DR. LANNO: Yes. Thanks, Chris. 

13 Our charge question was actually quite broad,

14 so there were not a lot of details we had to

15 respond to there. Our discussion centered

16 around the fact that, you know, there was

17 quite a bit of data added and the organization

18 of each section was nicely changed to

19 incorporate an introductory paragraph that

20 related to previous AQCD documents and then a

21 brief summary was provided in each section to

22 summarize what was discussed there. And it

Page 163

1 was broken up into the three different

2 environmental categories. So terrestrial,

3 fresh water, marine ecosystem because of the

4 differences in the environmental chemistry of

5 lead in those situations. 

6 And our biggest comment was that,

7 although a lot of new information was provided

8 -- maybe I could have bulletized that a bit

9 better, but sorry about that. This is one of

10 those "oh, my God" slides. Okay.

11 I think that the information was

12 not, it needs to be summarized in a way that

13 people can quickly see what it's about and

14 integrated into a meaningful synthesis. I

15 guess if that synthesis idea comes across in

16 chapter five and may make this chapter also a

17 candidate for reevaluation after its revision

18 this time so a third reading. I don't know if

19 the rest of my group concurs with that, but I

20 think that if it's going to be synthesized, I

21 think we could look at it as a whole again. 

22 So that's, I think, one of our comments.

Page 164

1 And the additional thing is

2 there's not that much technical evaluation of

3 the data that exists. And by technical, I'll

4 get to that in a second what we really mean by

5 that, but it's kind of defining more clearly

6 what the exposure doses were, what the

7 situations or the environmental conditions of

8 exposure were, and relating that to where at

9 an ecosystem level do these effects, could

10 they potentially occur.

11 And we provided some guidance as

12 to how they might -- so our second part of the

13 charge question there was recommend any

14 revisions to improve the discussion of key

15 information, and that's what we're trying to

16 do. So if we could get a table provided in an

17 appendix that summarize the data from all the

18 additional studies that have been included in

19 this document, that would be a place to start. 

20 And then some kind of technical evaluation of

21 that data for each of the studies. In

22 particular, Dr. Allen brought up the subject

Page 165

1 of that study that looked at I think the

2 effects of endocrine disruption effects in

3 cell culture are very, very low concentrations

4 of lead. 

5 And as an example of how you might

6 approach this, I didn't read the paper, but

7 what Dr. Allen related to me was that the

8 study was conducted by taking --

9 DR. JOHNSON: We have a problem. 

10 We have a medical problem. 

11 MR. HANLON: We are adjourning the

12 meeting now. We'll be sending an email to the

13 panel members with lists of milestones and

14 action items to follow up. Thank you and the

15 meeting is adjourned. 

16 (Whereupon, the above-entitled

17 matter went off the record at 11:58 a.m.)

18 

19

20

21

22
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ability 22:13 29:13

44:16 45:1 61:15

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43:2 67:2 110:2

132:19 142:15

above-entitled

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absent 144:14

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47:12 48:22

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acknowledging

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Acting 1:24

action 112:12

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activities 87:8

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110:11 113:17

116:5 124:4

125:21 137:12

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added 143:15

162:17

adding 124:14

142:2

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34:17 36:16 37:10

39:22 60:9 74:11

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ADHD 127:10

145:10,18 161:9

adjourn 5:10

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adjourning 165:11

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adjusting 26:20

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administrator's

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89:8 91:2 103:16

109:12,19 111:11

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airport 38:17 56:13

airports 34:21 53:3

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56:2,7 57:1 80:2,7

80:17

air-exposed 19:1

23:12 30:15

air-related 10:13

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33:18 37:7,8,12

40:4 47:15

al 106:13 146:13

algorithms 35:18

Allen 1:12,13 52:16

55:11 56:11 57:16

77:9 85:2 89:4

92:8 97:14,21

99:1,19 102:9

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106:18 164:22

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allows 71:12

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alternative 47:17

altitude 79:6,12,14

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10:21,22 11:20

12:4,11 13:6 14:7

14:7,10,14,18,20

16:4,6,9,13 18:11

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26:13,15,17,19,22

27:2,10 29:12

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38:16 44:6 49:16

50:10 51:12 54:2

68:13,17,20 69:16

75:20 76:5,6

87:20

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12:14 16:7 17:22

20:7 24:3 26:4,9

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36:7,7 37:13

39:12 41:20 43:22

63:4 95:12 116:21

119:2 125:9

126:15 138:18

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159:3

animals 161:19

answer 4:16 22:17

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130:4 131:22

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answering 84:18

115:8

answers 88:19

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anthropogenic

8:15 10:8 50:6

anticipated 43:3

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anybody 74:6

96:16

anyway 101:9

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124:1

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121:8

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93:19 147:5

164:17

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applied 136:10

applies 132:9
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apportionment

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appreciate 6:6

approach 18:5,7

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approaches 24:5

approaching 43:18

appropriate 106:21

116:11 118:5,13

127:14 134:5

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appropriately

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APRIL 1:6

AQCD 162:20

AQS 87:12,22

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area 24:15 51:13

125:11 144:12

155:15 156:19

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areas 13:4 21:16,17

29:8 39:21 56:6,9

101:3,6 124:6

125:1 127:3 137:5

137:9 142:3

144:14 145:5,9

argument 99:5,6

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asked 28:18 46:19

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asking 42:5,21

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aspect 29:3 31:9

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assessed 160:17

assessment 2:14

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6:18,18,19 7:7,20

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10:1,16 11:16

16:12 18:2,6,15

24:1 26:2 27:20

28:8,13,15 29:4,5

29:10 31:1,10

32:22 34:11,14,20

36:5 40:21 41:1

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63:11 64:5,14

65:1,3,15,22 66:4

66:21 67:3,5,9,20

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82:19,21 83:3

105:2

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73:21,22 91:6

axis 112:7

a.m 1:9 3:2 107:5,6

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B

B 1:8

back 4:8 11:17

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86:12,20 87:17

88:1 89:7 99:11

105:13 109:9

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148:17 151:17

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Bailey 137:11

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128:22 131:5

140:6

base 41:4 149:19

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126:8 131:10

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29:12 49:11 69:7

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45:2,17,18,20

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97:4 102:14,19

103:3 106:3 110:1

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139:9 149:22

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33:15 40:2 128:3

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22:15

bit 25:18 38:3 41:3

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54:12 60:22 62:5

67:21 75:8,11

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114:4,19 130:11

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158:13 159:14

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33:2,4,11 42:8,9

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81:21 103:16

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Bob 87:2

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cake 98:3

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calls 141:19

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Canfield 1:13 82:5

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capacity 73:16

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catch 120:17

catchall 108:19

categories 21:5

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category 79:17

causal 126:13,19

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143:16,22

yesterday's 123:22

Z

Zach 6:2 7:2 13:7

39:5 40:16 41:6

41:16 47:15 57:18

58:16 59:15 64:15

68:3

zero 112:8,9

0

0.06 86:9

0.5 14:1

0.6 14:1

0.99 93:6

1

1.0 92:17

10 92:22 99:8 135:2

135:4

10:19 107:5
202-234-4433

Neal R. Gross & Co., Inc.

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10:35 107:3

10:38 107:6

11 1:6 152:2

11:58 165:17

12 14:8 107:10

12:30 5:10,11,13,14

5:14 107:8,9

15 19:5

15-minute 107:2

165 2:19

18 86:10

2

2A 116:7

2B 122:3

20 107:14

2008 6:16 7:7,16

8:2 31:10

2010 70:21

2011 88:5

2012 1:6

2013 70:15 81:8

21 56:5

23rd 85:10

25 135:2,4

28 14:8

3

3 92:21

3A-13 87:14

3,000 79:8

3.5.3 106:2

3.5.4 90:10

30 123:3

4

4-22 112:1

4-3 103:9

4.1 109:1

4.1.3.3 109:4

4700 1:8

5

50-page 142:21

500 53:5

7

7 2:14

70s 120:4

73 2:17

8

8:30 1:9

8:32 3:2

9

95th 61:19