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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 + + + + +

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 LEAD REVIEW PANEL

 + + + + + 

 PUBLIC MEETING

 + + + + +

 THURSDAY, JULY 21, 2011

 + + + + +

 The meeting convened in Salon BCD

of the Marriott at Research Triangle Park,

4700 Guardian Drive, Durham, North Carolina,

at 8:30 a.m., H. Christopher Frey, Chair,

presiding.

CASAC LEAD REVIEW PANEL MEMBERS PRESENT:

H. CHRISTOPHER FREY, Chair

GEORGE A. ALLEN

HERBERT ALLEN

DEBORAH CORY-SLECHTA

CLIFF DAVIDSON

PHILIP E. GOODRUM

SEAN HAYS

PHILIP HOPKE

CHRIS JOHNSON

SUSAN KORRICK

MICHAEL KOSNETT

ROMAN LANNO

RICHARD L. POIROT

JOEL POUNDS

MICHAEL RABINOWITZ

WILLIAM STUBBLEFIELD

IAN von LINDERN

GAIL WASSERMAN

MICHAEL WEITZMAN
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U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF

PRESENT:

AARON YEOW, Designated Federal Officer

VANESSA VU, Director, SAB Staff Office

BRYAN HUBBELL

ZACHARY PEKAR

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 C-O-N-T-E-N-T-S

Reconvene 4

EPA Presentation - Overview of Risk and

Exposure Assessment Planning Document 9

Health Risk Assessment Issues 71

Welfare Risk Assessment Issues 131

Summary and Action Items 177

Adjournment 183

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

2 8:30 a.m.

3 DR. FREY: Okay, good morning. 

4 Our main agenda item today is a consultation

5 on the scope and methods plan for the risk and

6 exposure assessment. Before we get to that I

7 just wanted to summarize a few scheduling

8 issues related to the review of the ISA that

9 we discussed yesterday. 

10 I was very pleased to get draft

11 responses to the charge questions from I think

12 all but one of the questions and for that one

13 I put in a placeholder of what I thought the

14 answers were. I've compiled that and emailed

15 that to Aaron and asked him to email that to

16 the panel so that you can reflect on that. 

17 What I would like is while this is all fresh

18 and you are excited about this topic is to

19 just go ahead and try to revise your own

20 individual comments and submit those, and also

21 if you have input you want to give to the lead

22 lead discussant on the charge questions that

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1 you're interested in, to do that within about

2 a week. And then to ask the lead discussants

3 on the charge question to make whatever

4 revisions there are to the charge question

5 answers within about a week. 

6 And I know some of us are on

7 travel and vacation, I actually personally am

8 away the next two weeks, but you know, I think

9 as long as you have access to email and if you

10 can do it I think it's worth just trying to

11 get this done while it's fresh. So you know,

12 it would be good if by say next Friday, July

13 29th is the target date for your individual

14 input to the lead discussants and trying to

15 revise your individual comments. If you have

16 something that precludes getting it done in

17 that time frame, you know, so be it but if you

18 can try to do that that would be I think

19 helpful to the process. 

20 And then if the lead discussants

21 can get a revised set of charge question

22 answers on or about August 5th that would be
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1 helpful. Once we get that Aaron and I will --

2 and I guess Aaron in particular will be able

3 to go then go -- so we will have an

4 opportunity to discuss and make further

5 revisions if needed to the responses to the

6 charge questions and to the letter to the

7 administrator.

8 With regard to the points for the

9 letter for the administrator, I have drafted

10 about two pages based on my interpretation of

11 yesterday's discussion. And if we have time

12 later this morning we'll come back to that. 

13 And I would like to try to review that and get

14 your feedback while we're face to face. But

15 the priority today is the consultation on the

16 scope and methods plan. So are there any

17 questions about the process going forward with

18 the review of the ISA on the points that I

19 just mentioned? Okay. Yes, Rich.

20 MR. POIROT: So if we're not going

21 to review the response to the charge questions

22 does that mean we're going to have another

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1 call or some sort of --

2 DR. FREY: Yes, there will be a

3 teleconference. Yes. So, we want to give you

4 an opportunity to make revisions because you

5 know, last night or this morning I got the

6 first draft of responses. Just to make sure

7 all the discussants have seen that, have a

8 chance to provide feedback to the lead lead

9 discussants. Other panel members may have

10 thoughts about what they think should go in

11 that. So the panel can iterate, you know, by

12 email, but just remember cc Aaron anytime you

13 email. And email should just be among small

14 numbers of panel members. You shouldn't email

15 the whole panel for example because that's

16 considered deliberation. 

17 Once we get the draft in about two

18 weeks then Aaron will schedule a

19 teleconference. That teleconference will

20 probably happen late August/early September. 

21 That'll be the chance for a review of our

22 responses and then we can make revisions if

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1 needed beyond that. At some point then when

2 we consider among ourselves if that's final it

3 will go to the statutory CASAC for their

4 review. That'll probably happen in late

5 September. Okay? All right.

6 Well, the agenda today is EPA will

7 present on the scope and methods plan for the

8 risk and exposure assessment. My

9 understanding is we don't have any public

10 comments. We'll then have discussion on

11 health risk issues followed by discussion on

12 welfare risk issues and then we'll summarize. 

13 We'll probably take a short break. There's no

14 break in the agenda, but we'll probably take

15 a short break after the health risk

16 discussion. And with that I would like to

17 introduce Dr. Zachary Pekar and Dr. Bryan

18 Hubbell of the U.S. EPA and turn the floor

19 over to them to present to us on the scope and

20 methods plan.

21 DR. PEKAR: Excuse me, I have a

22 little bit of a summer cold. I'm not sounding

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1 quite as clear as I might. I wanted to thank

2 the panel members for taking the time to come

3 here and also to review the document. And I

4 just wanted to begin by giving an overview of

5 the purpose of the planning document. So

6 essentially the planning document was intended

7 to assess the evidence released or published

8 since the last review. And based on a review

9 of that evidence to determine whether we felt

10 we should -- whether the support for doing a

11 quantitative risk and exposure analysis both

12 to characterize human health and/or to look at

13 ecological and welfare effects. And in terms

14 of looking at that issue we considered a

15 number of factors. One thing we did obviously

16 is look back at the risk assessment that was

17 completed for the last review a couple of

18 years ago and look at the critical

19 uncertainties and limitations of that

20 analysis. Because when we're considering

21 evidence that's been published since that time

22 a critical issue is do we believe that that
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1 evidence has the potential to address

2 uncertainties or key limitations in the risk

3 assessment such that we would have a

4 substantially improved risk assessment. And

5 specifically do we think that the risk

6 estimates that would be generated would have

7 a significant reduction in overall

8 uncertainty. So that was sort of the approach

9 that we took. 

10 The document itself is organized -

11 - first it takes a look at the issue with

12 regards to human health risk characterization

13 and then it looks at welfare and ecological

14 risk. And this, the short presentation that

15 Bryan and I are going to give will follow that

16 order. So first I'll talk about the human

17 health aspects of this issue of the planning

18 document, giving an overview, and then Bryan

19 will cover the ecological and welfare risk

20 assessment.

21 So I'd like to begin just by

22 giving a brief overview of the risk assessment

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1 itself that was completed for the last review

2 a couple of years ago. A number of you

3 participated as CASAC members in the review of

4 that analysis and may have -- just be familiar

5 with the analysis in general. It was a pretty

6 complicated risk assessment and so you know I

7 don't really have time here to go through the

8 full assessment in detail or we would be here

9 probably for a few hours. So my goal really

10 here is to touch base on a couple of the

11 critical design elements that sort of anchor

12 us again in the approach that was used that

13 sort of sets up this discussion of

14 uncertainties and limitations in that analysis

15 with regards to current evidence that's been

16 published. 

17 So the risk assessment that was

18 completed in the last review focused on

19 assessing IQ loss in children up to seven

20 years of age. That was the target population

21 of the analysis and the endpoint that we

22 focused on. It was a case study-based

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1 analysis and what that meant is that we had a

2 number of different case studies that we

3 looked at. Those case studies could be sort

4 of broadly divided into two categories. One

5 category of case study looked at children that

6 were exposed at ambient air levels near the

7 current standard, and there were two case

8 studies that looked at that issue. One was

9 the primary lead smelter case study looking at

10 Herculaneum where ambient air levels were

11 fairly close to the standard level, the then

12 in effect standard level. And also, a general

13 urban study area, a case study which looked at

14 a smaller population, a hypothetical but we

15 believed probably existent to some extent

16 population of children exposed at the standard

17 level that would be assessed. And so both of

18 those case studies allowed us to look sort of

19 at the levels of risk that we would expect for

20 children exposed at various standard levels

21 that we considered.

22 The second category study areas

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1 attempted to look at a more representative,

2 realistic, broader urban kind of exposure

3 which would have children exposed at a variety

4 of levels. And we looked at three segments of

5 three different cities, Chicago, Cleveland and

6 Los Angeles using ambient monitoring data for

7 those specific locations as well as

8 demographic data. 

9 The analysis was multi-pathway in

10 nature and that reflected the fact that there

11 are non-linearities in both predicting blood

12 lead and in the concentration response

13 functions used to assess IQ loss. And when

14 you have non-linearities in both the biometric

15 that you're predicting and the endpoint then

16 you need to consider total exposure because

17 you need to know where you are along these

18 various curves in order to be in the sort of

19 correction location with regards to slope. So

20 in other words you can't just look at the air21 related exposures, you have to consider full

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1 The pathways, we considered a

2 number of different pathways. Those can be

3 sort of divided into air-related pathways and

4 sort of an other category of pathways. In

5 relation to air-related pathways we looked at

6 direct inhalation obviously. We looked at the

7 ingestion of indoor dust that is loaded in

8 part from ambient air outdoors that has been

9 transported inside, into the residential

10 dwelling. And we also looked at outdoor soil

11 lead. All three of these pathways being

12 clearly potentially air-related to some

13 extent. 

14 If we -- I guess to give a little

15 more detail on that, the indoor dust proved to

16 be a critical pathway, meaning the ambient

17 outdoor air loads indoor dust and that

18 provided a relatively large fraction of

19 overall air-related exposure. And you'll

20 recall if you're familiar with the analysis we

21 actually developed an indoor dust residential

22 model that was a combination of a mechanistic

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1 compartmental model with an empirical

2 component to try to look at the contribution

3 from non-air sources to indoor dust, for

4 instance, lead paint in older housing. There

5 was a fairly complicated model that had a

6 number of different elements to it.

7 Another factor that we had to do

8 is we attempted to distinguish recent air9 related exposures from past air. And what we

10 meant really by that was from sort of an

11 applied standpoint was if we adjusted an

12 ambient air standard, if we looked at a lower

13 standard, what dial were we actually changing. 

14 In our risk model we, in looking at an

15 alternate standard level we could look at an

16 effect on direct inhalation obviously. We

17 could also look at an effect on indoor dust

18 ingestion, that residential ingestion

19 scenario. But for instance we did not predict

20 changes in outdoor soil because of the

21 limitations in methods and data to do that.

22 Other pathways that we considered

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1 were paint. Sort of as I already mentioned

2 that would have been as a portion of the

3 indoor dust exposure pathways obviously as

4 well as outdoor soil. We also looked at diet

5 and drinking water. Now, diet and drinking

6 water clearly can be loaded to some extent

7 from ambient air but for purposes of the risk

8 assessment we didn't establish that linkage in

9 a way where we could change diet or drinking

10 water exposure with a change in ambient air. 

11 So we had those as fixed pathways based on

12 data that we had from the literature in terms

13 of like concentrations in those media. So it

14 was a fairly complicated exposure modeling

15 effort in terms of the different pathways that

16 were included.

17 In terms of characterizing ambient

18 air lead levels depending on the case study

19 that we're talking about we either used

20 ambient monitoring data to establish levels,

21 ambient air levels, for instance in the

22 location-specific urban study areas in

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1 Cleveland, in Chicago, or we used dispersion

2 modeling for instance with Herculaneum where

3 we wanted to get a fairly detailed gradient

4 characterization in ambient air levels away

5 from the facility. So we used a combination

6 of monitoring data and dispersion modeling. 

7 In terms of the exposure metric

8 that was used we used blood lead because that

9 obviously was related given the Lanphear study

10 which I'll talk about in a second that we used

11 as the basis for the concentration response

12 functions for IQ loss. We needed blood lead. 

13 And we used a variety of different blood lead

14 metrics, concurrent lifetime average, other

15 metrics that people are familiar with. In

16 modeling blood lead we used IEUBK to predict

17 a geometric mean blood lead value for the

18 population we were looking at and then used a

19 GSD, a geometric standard deviation obtained

20 from the literature to characterize blood lead

21 variability around that mean. So what we did

22 not do for the last risk assessment was
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1 conduct for instance a probabilistic

2 simulation of a group of children by running

3 individual children or subsets of children

4 through IEUBK. We allowed -- we used

5 statistically derived characterizations of

6 variability in the population to get us that

7 spread.

8 And something I'll talk about in a

9 second with regards to uncertainty in the

10 analysis I think is the critical issue of

11 pathway apportionment. So when we go and we

12 run IEUBK for these various pathways we have

13 the ability then to look at the contribution

14 of various pathways to that geometric mean

15 blood lead value that we get for a population. 

16 Then we use the geometric standard deviation

17 to get a high-end, let's say upper percentile

18 child blood lead value. The real challenge in

19 a critical uncertainty and analysis and I

20 think a critical aspect of the assessment in

21 general is the effort to pathway-differentiate

22 a high-end percentile. So if you have a child

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1 you've modeled at three micrograms per

2 deciliter geometric mean, a geometric mean

3 value for a group of children and at the 95th

4 percentile you're predicting that you have a

5 10 micrograms per deciliter child. Critical

6 to us is trying to disentangle the air

7 pathway-related contribution. There's a lot

8 of uncertainty in doing that. We may be able

9 to make that estimate for the geometric mean

10 child, but how those pathways play out at the

11 high end was a critical aspect of the analysis

12 and an important uncertainty that I'd like to

13 highlight.

14 So and then in terms of

15 characterizing IQ loss, with regards to

16 predicting IQ loss we used the Lanphear (2005)

17 pooled analysis in essentially a number of

18 different functions derived from that study

19 and from the data published in that study and

20 the information published there. We had four

21 different concentration response functions,

22 two that were log linear in form and two that

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1 were dual-linear that had break points at

2 various points, I think 7.5 micrograms per

3 deciliter and 10 micrograms per deciliter. I

4 have to check myself there, but I think that's

5 what we did. So that's a quick sort of

6 thumbnail sketch of the key modeling elements

7 and aspects of the analysis that was conducted

8 last time.

9 And then that sort of sets us up

10 for a brief discussion of some of the key

11 uncertainties and limitations in the analysis. 

12 And I'm going to touch on these briefly. 

13 Obviously in the plan we laid out each one of

14 these in more detail so I'm not going to go

15 over that in too much -- I'm going to assume

16 we're going to be maybe talking about some of

17 these. 

18 So in terms of temporal aspects,

19 we assumed that while we had varying exposure

20 parameters in terms of ingestion rates and

21 other factors for the children that we modeled

22 with regards to modeling blood lead and IEUBK,

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1 the immediate concentrations were assumed

2 fixed over the seven years that we simulated

3 a child for. That introduced uncertainty. 

4 With regards to the general urban study area,

5 so we characterized an exposure and risk for

6 the subset of children exposed at the standard

7 level, but generalizing that or extrapolating

8 that to a broader population, meaning trying

9 to have an understanding of how many children

10 might experience that kind of exposure, how

11 ubiquitous or how common that hypothetical but

12 likely to exist scenario was. We had

13 challenges in doing that because of

14 limitations in our monitoring data within

15 urban areas. So that was an uncertainty also.

16 Similarly, when we modeled the

17 location-specific study areas in the different

18 cities that we actually looked at, the

19 monitoring data, we did have multiple monitors

20 in those urban locations but they weren't

21 common enough to really give us a gradient

22 that we had a lot of confidence in. So there
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1 was uncertainty in characterizing the

2 population gradients in exposure and risk in

3 the location-specific urban study areas. 

4 Furthermore with regards to air

5 quality when we looked at alternate standard

6 levels we need to roll back or we need to

7 simulate attainment of these standard levels

8 in the different urban locations, and there's

9 uncertainty in doing that. That's typically

10 referred to as rolling back a monitor. And so

11 the way that we would do that, is that going

12 to be -- is there going to be some kind of

13 rollback that reflects targeting specific

14 sources, or is it going to mean more

15 generalized urban rollback that's going to be

16 proportional. There was uncertainty in that.

17 With regard to outdoor soil and

18 dust concentrations, I mentioned this I think

19 sort of to a certain extent earlier. We

20 didn't really have the data and methods in

21 place for simulating a change in outdoor soil

22 lead levels reflecting a change in an ambient

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1 standard level and I think part of that is

2 that there's a large historical signal that

3 reflects you know previous very elevated lead

4 levels. And knowing how a change in sort of

5 current ambient standard or ambient air lead

6 levels would translate into a change in soil

7 and what kind of temporal profile you would

8 see for that, there was uncertainty in that. 

9 So we assumed as I mentioned earlier that

10 outdoor soil lead levels were fixed, that

11 there was no change in outdoor soil lead

12 levels reflecting a change in air quality

13 standard. 

14 In terms of indoor dust, as I

15 mentioned we had this residential dust lead

16 model that we used. We also had empirical

17 models that we used. For instance, at the

18 Herculaneum site we actually derived an

19 empirical relationship relating outdoor

20 parameters to indoor dust. So there were a

21 number of different models used at different

22 study areas and without getting into a lot of

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1 detail here in this overview there were a

2 range of uncertainties related to those indoor

3 dust models. 

4 There's loading the concentration

5 conversions that were involved, there's the

6 departmental models themselves have cleaning

7 efficiencies, other factors that obviously you

8 know we would treat as uncertainty in terms of

9 characterizing those parameters and developing

10 those models.

11 I already touched on the second

12 bullet here earlier because of its importance. 

13 We could characterize and predict a high-end

14 blood lead value for children in our

15 simulations but -- actually, sorry, it's the

16 second model. So we did have uncertainty in

17 even characterizing high-end blood lead

18 values. 

19 If we've estimated a geometric

20 mean blood lead value for a population of

21 children, having a geometric standard

22 deviation that's representative of that

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1 population we would have gotten that GSD from

2 for instance NHANES. There were some other

3 studies that we considered that looked at

4 blood lead variability but linking sort of the

5 correct statistical characterization of

6 variability to the right population is an

7 uncertain process itself.

8 And then the second to last bullet

9 here has to do with that pathway apportionment

10 that I mentioned. That's a critical issue

11 because if we're interested in children with

12 relatively elevated blood lead values, if we

13 can get that absolute estimate of total blood

14 lead we can convert that into an IQ loss

15 estimate but then apportioning what fraction

16 of that comes from air-related pathways and

17 therefore is sort of policy-relevant in the

18 context of what we're talking about with a

19 NAAQS review, that became a critical issue of

20 uncertainty that we had to deal with.

21 And then finally, in terms of IQ

22 loss concentration response functions, we also
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1 needed to look at the concentration response

2 functions at the sort of lower blood lead

3 values, around 5 micrograms per deciliter and

4 lower, and there was uncertainty in

5 characterizing the nature of that slope at

6 that point. So I think those are some of the

7 critical sources of uncertainty and

8 variability in the previous analysis, once

9 again that we look to current evidence to see

10 whether we could really critically address any

11 of these issues.

12 So the overall observations we've

13 presented which I'm sure CASAC panel members

14 are familiar with from looking at the

15 document. You know, essentially in looking at

16 the evidence published since the last review

17 we're pretty confident that that evidence

18 would allow us to place the risk estimates

19 that we generated for the last review in

20 greater context, probably from a qualitative

21 standpoint look at some sources of uncertainty

22 and characterizing uncertainty better from a

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1 qualitative standpoint. But our overall

2 conclusion was we don't really believe that

3 the evidence puts us in a markedly different

4 position in terms of conducting a quantitative

5 risk assessment that would really

6 substantially address any of these critical

7 uncertainties, and that would likely generate

8 risk estimates that would have a markedly

9 different degree of uncertainty relative to

10 the risk estimates we generated from the last

11 review. I think a critical factor there, once

12 again there is this issue of pathway

13 apportionment which remains a very important

14 aspect of uncertainty I think in the overall

15 analysis. So anyway, that's sort of an

16 overview of the plan with regards to human

17 health and I'll turn over the discussion to

18 Bryan.

19 DR. HUBBELL: And in the interest

20 of full disclosure I'm not an ecologist and my

21 staff ecologist who was going to be able to

22 present the information and developed the

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1 document was unable to be here today, but I

2 will give you an overview of where we are in

3 terms of our understanding of the past

4 analysis that we conducted for the last review

5 and the new information that's been available

6 since then on ecosystems. 

7 One thing I did want to mention is

8 that we will also just briefly introduce that

9 we did introduce in this plan document the

10 concept of critical loads directly as a

11 concept for risk assessment building on some

12 things that the agency has been working

13 through on other reviews, and I'll relate that

14 to what we did in the past review as well. 

15 So for the last review we

16 conducted a screening level assessment for

17 three case study areas focused again similar

18 to the health study on a primary smelter area

19 where there was a long history of lead

20 emissions that were likely to affect the soils

21 in and around that smelter. There was also a

22 secondary smelter which is a smaller source

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1 and then a non-point source which was a near2 roadway non-urban source that would allow us

3 to look at roadway-type lead emissions. 

4 And in addition, a fourth area

5 that was selected because it was ecologically

6 sensitive, this was the Hubbard experimental

7 forest area. It was assessed but was not part

8 of the quantitative assessment because of

9 limitations in the ability to quantify the

10 risk changes. And there was also a national11 scale screening assessment to try to look more

12 broadly at lead concentrations in different

13 media to determine whether they were

14 considered to be potentially at risk. The --

15 I'll also mention that these screening-level

16 assessments were based on -- not directly on

17 the concept of critical loads, but they

18 instead were based on this idea of hazard

19 quotients which is fairly directly related to

20 elements of critical load analyses. 

21 But these were based on both

22 measured soil and water concentrations of
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1 lead, and also on some multimedia modeling of

2 lead emissions and fate and transport. And

3 the focus was on, again, not on ambient lead

4 directly but on lead that was deposited to

5 soil and water, and the exposure of individual

6 organisms or groups of organisms to the lead

7 concentrations. It was not in an ecosystem8 wide or an ecosystem services based assessment

9 in the way that we tried to do in our most

10 recent NOx and SOx secondary standards review. 

11 And as with the health, one of the real

12 difficulties in conducting these analyses was

13 the ability to actually apportion the risk to

14 the different sources, air versus non-air

15 sources, and then recent versus past

16 concentrations.

17 The hazard quotient approach was

18 based on using Ecological Soil Screening

19 Levels and Ambient Water Quality Criteria

20 developed from the literature, and also the

21 soil screening levels were based on Superfund

22 criteria. The HQ was calculated as the

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1 estimated concentration of lead divided by the

2 soil screening levels or by the water quality

3 criteria. In the past analysis they did find

4 that at the previous standard levels there was

5 a number of areas with hazard quotient greater

6 than one indicating that the areas were

7 potentially at risk. But again, this is a

8 risk potential, not an actual measurement of

9 a welfare change. So it was a very limited

10 assessment of quantitative risk, it was more

11 of a potential for risk. 

12 So since the lead review was

13 completed we have been moving forward as an

14 agency with trying to put welfare risk in the

15 context of the consideration of critical load

16 models as a framing context for evaluating

17 risk. We did use that methodology for

18 critical loads in assessing the risks

19 associated with acid deposition and nitrogen

20 deposition in our evaluation of the NOx and

21 SOx secondary standards that was -- that's

22 currently underway. The proposed rulemaking

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1 just came out for that, that secondary

2 standard review, and in that review there's a

3 discussion about how critical loads can be

4 used as a framing concept. Because again, it

5 builds in the concepts of a critical limit as

6 well as concentrations and one of the critical

7 parts, however, that's not available for lead

8 is a real understanding of fluxes and of the

9 ability to apportion between the different

10 sources of lead. With NOx and SOx secondary

11 standards one of the limits there was in the

12 ability to deal with nitrogen because of all

13 the non-air loadings of nitrogen. But we were

14 able to set up a critical loads model that

15 really focused on acidification because the

16 primary source for acidification is from air

17 deposition. So we tried to frame our

18 conceptual model now in terms of critical

19 loads, but we were unable to actually

20 implement that in the case of lead.

21 So, the reason why the critical

22 load modeling was not really adopted last time

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1 in the last review was that the existing

2 studies, number one, there were no U.S.

3 critical load models at the time and the

4 studies that do exist did not incorporate

5 speciation of lead which was determined to be

6 an important factor in looking at ecological

7 loadings, or bioavailability of lead in the

8 different species into the critical load

9 models. As I mentioned there was an overall

10 lack of data regarding fluxes of lead within

11 systems that was used in the critical load

12 models. 

13 There was also issues with looking

14 at the compartmentalization between different

15 -- and the transport between different

16 ecological compartments. And as I mentioned

17 there weren't any studies in the U.S. which

18 made it difficult because the European studies

19 had very specific loadings that were

20 associated with particular geographical -- I'm

21 sorry, not geographical, geological attributes

22 as well as other ecological attributes.
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1 In the current review, the new

2 information does expand previous findings

3 regarding the bioavailability of lead, the

4 speciation of lead and the types of ecological

5 effects associated with lead, and there was

6 one study that did include the fluxes in their

7 critical load model. However, the ability to

8 apply a critical load modeling approach over

9 a large enough scale that could really change

10 the types of uncertainties that we felt

11 existed in the last review really doesn't

12 exist, even in trying to conduct a more

13 extensive pilot study in a number of different

14 smaller areas that might be affected. 

15 As a result, we feel that the

16 currently available data would not allow for

17 a critical load-based risk assessment that

18 would substantially change or improve on the

19 hazard quotient approach that we used in the

20 last review. But we do feel that the critical

21 load concept is an appropriate tool for

22 assessing ecological risk from lead moving

Page 35

1 forward and therefore that concept, that

2 critical load concept will provide a useful

3 framing device for considering the information

4 from the last review, the quantitative

5 information from the last review as we develop

6 our evidence base determinations moving

7 forward. That's it. Thank you.

8 DR. FREY: Okay, thank you. I

9 guess a general -- maybe a general

10 clarification that might help the panel would

11 be what, if anything, is actually being

12 proposed as an REA. So what I'm understanding

13 is the recommendation is essentially that --

14 from the staff is that there isn't really

15 enough new evidence to do a revision on the

16 quantitative assessments, but that new

17 evidence might help in interpreting the prior

18 analyses. Does EPA therefore propose to do a

19 document called an REA that provides that

20 interpretation? And if so, is there a scope21 in method for how that's going to be done, or

22 is there some other proposal?

Page 36

1 DR. HUBBELL: Yes, thanks for the

2 opportunity to clarify that. What we are

3 proposing is to not produce a separate risk

4 and exposure assessment document, that instead

5 this interpretation of the previous risk

6 assessment, quantitative risk assessment, will

7 be part of the first draft policy assessment

8 that would provide an overall interpretation

9 of the evidence and the risk information. But

10 we would not produce a separate risk and

11 exposure assessment because there is no basis

12 for updating that information. 

13 DR. FREY: Okay. So yes, I'd like

14 to open it to questions of clarification from

15 members of the panel. And I saw we have a

16 number. So I'll go with Rich and then Phil

17 and then George and then Michael.

18 MR. POIROT: I was wondering if

19 you could give some examples of how you see

20 the new information being used to re-interpret

21 or interpret the -- it sounds like a good

22 idea, but could you give some examples of

Page 37

1 what?

2 DR. HUBBELL: Well certainly, and

3 Zach can talk about it on the health side, but

4 on the eco side my understanding is that we

5 would take the information that was based on

6 the hazard quotients, try to put it in the

7 context of what it would mean in terms of

8 thinking about critical loads and then what

9 that would mean in terms of assessing do we

10 feel like under the existing standards or the

11 new standards that we would have existing risk

12 that would make us reconsider whether a

13 separate secondary standard would be

14 appropriate given that risk information. 

15 Again, it's really more just saying -- and the

16 information on bioavailability for example,

17 there were certain statements and other types

18 of information that was provided in the

19 previous risk assessment talking about

20 uncertainties. And again, it would be do we

21 feel like this reduces our uncertainty that we

22 stated about those previous risk results. 
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1 Because if we can say that, you know, we

2 really feel like there's less uncertainty

3 about whether air concentrations are causing

4 a risk then that's important information to

5 bring forward in terms of the weighting of

6 quantitative risk information versus the other

7 evidence. So to some extent it helps in

8 balancing and weighting the information that's

9 available as they make the policy

10 determinations. You want to talk about the

11 health?

12 DR. PEKAR: Yes I mean, you know,

13 I think, I mean one example for instance. 

14 When it comes to the indoor dust modeling

15 there's a Hunt study that provides some

16 cleaning efficiency information. And when we

17 first looked at that I anchored onto that as

18 a possibility for you know sort of looking at

19 that in relation to the residential dust

20 model. But if you look at that in more

21 detail, first of all it's only considering

22 hard surface floors, it's based on Herculaneum

Page 39

1 data and what it says is the cleaning

2 efficiencies seem to be greater than the

3 cleaning efficiencies that we use, but then

4 it's also suggesting that the particle size

5 left behind could be more accessible from a

6 child's standpoint. We summarized this and

7 I'm discussing it. So when I look at it, like

8 in that context that may not even -- it may

9 help us to frame a better understanding of

10 this particular critical issue of cleaning

11 efficiency. 

12 There's now a particle size of

13 what's left behind. We have a better way of

14 discussing uncertainty with regards to that

15 part of the model. I'm not even sure that

16 that would allow us to better characterize

17 biases or magnitudes because they sort of

18 argue in different directions and it's not

19 directly applicable to a generalized

20 residential scenario. But that does provide

21 some insights that would allow us to further

22 discuss that aspect of that model. That's you

Page 40

1 know one example. I think looking at some of

2 the NHANES data, you know, we may have refined

3 GSD characterizations we can look at. Once

4 again, I think that our ability to pathway5 apportion continues to be a real challenge

6 that when you look at a high end even if we

7 may have higher blood lead values that might

8 be slightly lower now depending on GSD

9 characterizations, you're not going to be able

10 to pathway-apportion those and so you're left

11 with that critical uncertainty which played

12 such a role as we used risk information to

13 inform policy decisions. But it's that kind

14 of thing where we would fold some of that into

15 a discussion to bring our understanding of

16 those elements in in terms of further

17 interpreting the risk information and elements

18 of the model.

19 DR. HUBBELL: And then just let me

20 further clarify that in the policy assessment

21 part of the review the risk information is

22 summarized and is put in the context of how to

Page 41

1 interpret different levels of the standard and

2 other pieces of, you know, other elements of

3 the standard. That part would still be

4 brought forward and a discussion would still

5 take place, but it would be based on the

6 previous quantitative risk information but

7 then again put into the interpretation of have

8 we changed the way we would make statements

9 about uncertainties, biases, the strength of

10 the information. That would all -- the

11 extrapolatability of the information. That

12 would all be placed within the context of the

13 newly available information. But again, we

14 would be bringing forward that same

15 quantitative risk information into the policy

16 document.

17 DR. PEKAR: And I think you know

18 one thing to keep in mind and we mentioned

19 this in the planning document is that there

20 are a number of incidences where the

21 populations for instance characterized with

22 regards to a particular endpoint in an epi
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1 study let's say is a population age range

2 that's beyond that that we can simulate given

3 IEUBK which becomes a limitation in the risk

4 assessment, but in the evidence analysis that

5 would be conducted as part of the policy

6 assessment that information would critically,

7 would obviously be considered. And so the

8 risk assessment is one piece of informing the

9 policy, the regulatory review, the evidence

10 analysis would still use a lot of the

11 information that we say may not be directly

12 usable to update a risk assessment. That

13 information would still be obviously

14 considered in the evidence analysis. I just

15 wanted to be clear about that. 

16 DR. FREY: Okay, Phil?

17 DR. HOPKE: Okay, I have a couple

18 of issues I'd like to raise. One is if in

19 fact the ISA is saying there is significant

20 amounts of submicron particle lead being

21 transported into the United States then we

22 need to seriously consider a policy-relevant

Page 43

1 background and a risk assessment has to be

2 adjusted to take into account a policy3 relevant background. Now, at this point the

4 ISA has not adequately assessed whether that

5 is or is not present, but that's clearly

6 something that you guys ought to jump on ORD

7 to make sure that they look to see whether in

8 fact there is a sufficient amount of

9 intercontinental-transported fine lead to

10 constitute a PRB and then you would need to

11 reassess your risk based on the -- if you're

12 going to take the traditional approach of

13 subtracting off the PRB that would change the

14 risk assessment -- that could change the risk

15 assessment somewhat. 

16 The other thing that concerns me

17 is that in the previous things that I can find

18 you're looking primarily at smelters as the

19 source of lead. If 49 percent of the lead now

20 comes from general aviation avgas why aren't

21 you looking at an airport scenario? Okay, let

22 me finish. You have a significant airport

Page 44

1 scenario, you often have residences living

2 next to it, you have home gardens, you have

3 the whole scenario that you've missed entirely

4 in these, you know, look at something like the

5 Van Nuys Airport or some of the other major

6 general aviation airports that are present in

7 the middle of residential areas. This should

8 be a much more, you know, given the fact that

9 smelters have now been pretty well controlled,

10 you have historic emissions, but current

11 emissions are pretty low, 49 percent is coming

12 from avgas and the risk assessment is silent

13 with respect to almost half of the lead in the

14 United States? That seems to be a major

15 oversight that needs to be addressed and I

16 don't see how you can just stick that into the

17 policy assessment.

18 DR. PEKAR: Can I respond to that?

19 DR. FREY: Sure.

20 DR. PEKAR: So you know, I think

21 when you look at the risk assessment, first of

22 all the primary smeltered Herculaneum would

Page 45

1 have been based on you know a smelter kind of

2 release. The other scenarios that were

3 modeled in general urban study areas used

4 monitoring data as the basis for

5 characterization. That's going to reflect

6 sources. And I understand the point that it

7 did not specifically look at a location near

8 an airport so let me get at that. 

9 DR. HOPKE: -- monitoring data.

10 DR. PEKAR: No, I understand that. 

11 If you look at the role that the different

12 case studies played in informing the policy

13 decision that was made last time the general

14 urban study area by far carried I think the

15 majority of the weight and the reason for that

16 was when we looked at the urban study areas,

17 the actual locations, there were large

18 gradients and only small, small segments of

19 the -- those modeled populations were near the

20 standard levels being assessed, so the overall

21 risk profiles tended to be very, very low. So

22 we ended up putting most of the emphasis on
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1 the general urban study area which is actually

2 looking at the question if you've got a

3 population at this standard level what is the

4 risk. 

5 So what's the characterization of

6 risk given our sort of relatively complicated

7 -- instead of using these empirical

8 relationships that we used in the evidence

9 analysis, if we use a more complicated risk

10 model what's risk for children exposed at that

11 standard level. Arguably that kind of

12 hypothetical scenario of kids being exposed at

13 the standard level which is fairly high, you

14 know, the initial standard level that was

15 being considered, the previous standard,

16 that's going to cover any population. It's

17 not going to give you a representative

18 characterization. Let's say that in the

19 locations you're talking about or other

20 locations you have a broader set of children

21 that are exposed at elevated levels. 

22 The general urban study area is

Page 47

1 going to cover virtually any population

2 because it's looking at a group of kids

3 exposed at that level and because of that it's

4 a very, very useful tool. The problem is you

5 don't know how to generalize it, how broadly

6 representative is it of children, but it is

7 looking at the situation where you have kids

8 exposed at that standard level. And so I

9 think given the critical role that that

10 played, just to finish my point, we said there

11 may be instances, because we don't have good

12 gradient information in a lot of these urban

13 study areas we look to the general urban study

14 area to cover kids exposed at those elevated

15 levels. And I would say that that probably,

16 that argument could be used to cover instances

17 near industrial facilities, instances near

18 airports if that's an elevated scenario.

19 DR. HOPKE: But only to the air

20 concentration, okay? And now you have the --

21 okay, again, I remember back to when we did --

22 when we reviewed the first product of MACT

Page 48

1 residual risk analysis for secondary smelters. 

2 The primary pathway for exposure was the home

3 garden in the downwind area. So you know,

4 you're neglecting food because you're assuming

5 it's coming from the grocery store. You're

6 not assuming -- I don't know how much hand7 mouth behavior, I mean again that was one of

8 the major things back when we had leaded

9 gasoline. So in this immediate downwind area

10 where you have the potential for surficial

11 soil contamination by the avgas combustion. 

12 It seems to me you're missing a potential high

13 exposure which would be different than almost

14 anywhere else in, you know, particularly

15 different than a point source high stack

16 scenario.

17 DR. PEKAR: So I think -- I mean,

18 it's a very good point, and I think what we

19 could do certainly is take a look at the media

20 concentration data and the other data that we

21 would have for some of these scenarios -- and

22 I know that that's been collected, you know,

Page 49

1 we're looking at that situation -- and look at

2 the extent to which the concentration data

3 that we used for instance in our general urban

4 study area or in the other urban areas

5 provides coverage for the magnitude of pathway

6 exposure of media concentrations that you

7 would be talking about. So for instance we

8 used general urban soil concentrations and

9 outdoor ingestion, we did look at that. So

10 you know, would we have provided some degree

11 of coverage or not. I mean I think that's a

12 fair --

13 DR. HOPKE: What I'm suggesting is

14 maybe you could do at least a few scenario

15 assessments with -- I mean, there are specific

16 modeling tools. I mean, I've been doing a lot

17 of work with TRB kinds of things recently. 

18 They just had an RFP for looking at lead in

19 the near field of airports. Now that work has

20 just started, but they're doing a literature

21 review that you might be able to get your

22 hands on fairly quickly, and there are already
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1 specific emissions inventories for airport

2 operations, and so at least do some screening

3 estimates would seem to me worthwhile to see

4 whether in fact these areas are significantly

5 different. Because they haven't been in

6 general monitored and we don't really know

7 what the gradient off of those airports are in

8 terms of lead and the near field exposures.

9 DR. HUBBELL: Let me also make a

10 clarification or a point about the PRB

11 question which is we're in the process of

12 reconsidering how we think about background

13 concentrations and the role of international

14 transport into the U.S. And at this point

15 obviously if the ISA hasn't fully

16 characterized that it's very difficult to

17 incorporate that into a quantitative risk

18 assessment. And it's not also clear that we

19 would want to do that at this point.

20 We're focusing more for example in

21 thinking about a number of different

22 pollutants and trying to think about the

Page 51

1 fractions of risk that come from different

2 sources, whether they be within the U.S. or

3 outside the U.S., but considering them as we

4 have in the past of saying well, those are not

5 likely controllable. We're reconsidering that

6 idea as a way of thinking about risk and

7 focusing more on, you know, what is really

8 truly natural background relative to maybe

9 background concentrations that are coming from

10 international sources. So I'm not sure that

11 we want to go there yet, and certainly the ISA

12 would need to progress quite a bit further in

13 terms of characterizing the background

14 concentrations before we go anywhere with

15 quantitative risk adjustments.

16 DR. HOPKE: Right, but at least it

17 should be acknowledged that it's a potential

18 out there, and you guys need to keep in good

19 contact with the ORD folks who are trying to

20 put this together because one would hope that

21 it gets -- something quantitative gets put

22 into the next round of the ISA that says one

Page 52

1 way or the other, you know, rather than vague

2 statements that there's transport.

3 DR. HUBBELL: I agree and, again,

4 that can be put into the policy discussion

5 without having to go through trying to

6 quantitatively address how that would affect

7 the quantitative risk assessments. 

8 DR. HOPKE: If the ISA is supposed

9 to inform the risk assessment and the policy

10 assessment then we need to see that

11 progression.

12 DR. HUBBELL: Yes, agreed.

13 DR. FREY: Okay, George?

14 MR. ALLEN: Thanks, Chris. I had

15 a question on slide 5, the last bullet or

16 maybe the last two bullets talking about

17 simulating the impact of change in the lead

18 standard on soil lead levels, the role of so19 called old soil lead. In the presentation it

20 went by a little too fast for me, there was --

21 so the question is what assumption was used

22 regarding how fast soil lead might change if

Page 53

1 the NAAQS changed? Was there -- I just, I

2 thought I heard no change, but I'm not sure.

3 DR. PEKAR: No, that's right. For

4 the previous risk assessment we did not

5 simulate any changes in outdoor soil linked to

6 the ambient air.

7 MR. ALLEN: In other words, so if

8 we -- if the NAAQS were to -- if

9 concentrations were to drop as a result of

10 maybe a tighter NAAQS, then the assumption

11 here was that soil level lead historical would

12 not change. I just want to make sure because

13 that's --

14 DR. PEKAR: That's right.

15 MR. ALLEN: Okay, thank you. 

16 That's really my only question.

17 DR. FREY: Okay. Michael?

18 DR. KOSNETT: Thanks very much for

19 your presentation. Regarding that same

20 question that George just raised, as I

21 understood it you do model what they call

22 recent air and past air, right? And doesn't
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1 past air consider the -- doesn't past air

2 include dust that came from outdoor soil

3 that's tracked into the house and that kids

4 are exposed to?

5 DR. PEKAR: Yes, so I mean the

6 operational definition of recent air versus

7 past air is if you imagine the NAAQS being a

8 dial and as you turn down the dial what

9 pathways in our risk model could we actually

10 adjust. And so recent air pathways and indoor

11 dust, there was a compartmental model so we

12 actually had a linkage between ambient air and

13 indoor dust for a portion of it. 

14 And then there was an empirical

15 element that -- sort of a total dust modeling

16 estimate that we had from data from different

17 housing stocks. And so we would look at a

18 fraction that came from air-loading changes

19 and then the leftover would have been paint

20 plus tracked-in soil, not knowing sort of the

21 differentiation of those two. But yes, so the

22 old air would have been the soil tracked in

Page 55

1 part that we couldn't adjust empirically.

2 DR. KOSNETT: Okay.

3 DR. PEKAR: So -- yes.

4 DR. KOSNETT: So you count past

5 air but you don't change it with the model.

6 DR. PEKAR: Yes, so you would have

7 seen a category that -- in presenting the risk

8 information in our tables in the previous risk

9 assessment there were different sort of

10 ranges, and you would see those ranges change,

11 and part of those ranges that wouldn't have

12 changed would have been the past air that we

13 couldn't adjust. It would have been really

14 nice if we could have teased out, for

15 instance, outdoor soil from paint to tell, you

16 know, management that yes, this portion could

17 also potentially be affected, we just can't

18 tell you how much. But sometimes we had to

19 leave those things bundled because we couldn't

20 differentiate, for instance, paint from

21 tracked-in soil.

22 DR. KOSNETT: Okay. The issue of

Page 56

1 looking at the change in soil with change in

2 air sources or sources being dialed down

3 raises a point that Michael said the other day

4 about smelters being closed and people looking

5 at soil lead concentrations over time. You

6 know, EPA as you know has, especially the

7 Superfund division has this vast database of

8 all their records of decision and their

9 samplings you know around these sites. Would

10 it be worthwhile consulting with any of your

11 colleagues who have looked at some of the

12 sites around smelters to see if there was any

13 historical changes in soil sampling?

14 Because I know from the limited

15 number of ones I've been involved with, you

16 know, typically what happens is that there's

17 a smelter operating, they measure some soil

18 samples, there's concern raised about a

19 contamination or whatever, it finally shuts

20 down. By the time the cleanup gets done it's

21 like 10 or maybe more years later and over

22 that time they sometimes have gone back and

Page 57

1 gotten more soil samples, sometimes they re2 sampled the property right before they did

3 the, you know, the cleanup to make sure, you

4 know they want to get more data or whatever.

5 I bet there's a good chance if we

6 get someone with a lot of institutional

7 knowledge in the Superfund site that they

8 might -- it might not be published, you know,

9 in the open, but it's in the data. If you dig

10 down I bet there might be some sites where

11 they have about a decade difference in soil

12 before and after a smelter closed down.

13 DR. PEKAR: I think that may be

14 true. I know with the Herculaneum data we

15 looked at some of this in different

16 exploratory analyses with regard to

17 Herculaneum, and the problem with some of

18 these locations is they'll have remediation

19 where they strip out soil, put fresh soil. 

20 There may be loadings but often the ambient

21 levels you're dealing with are much higher

22 than the levels we may be talking about here.
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1 So even if you got a -- I'm not

2 saying this is a conclusive statement, I'm

3 just saying some of the concerns that we found

4 are if you even could derive a unitized

5 relationship it may be for a range of ambient

6 air levels that aren't as relevant to what

7 we're talking about near the current standard

8 which is much lower than what you typically

9 would have at some of these. Even a natural

10 experiment you may be looking at sort of a

11 huge step-down.

12 And trying to tease that out in

13 terms of a relationship between a unitized

14 change around 0.15 micrograms per -- you know

15 and soil change over time, I would have --

16 it's a hypothesis certainly and it's something

17 I think that's reasonable to check into, but

18 I would have some of the concerns I just

19 raised with regards to -- because we need an

20 explicit relationship there that allows us to

21 really get that change in sort of the surface

22 contact soil.

Page 59

1 DR. KOSNETT: Okay. And then the

2 other question I had in line with what Dr.

3 Hopke just said about the airports. Just last

4 week in Environmental Health Perspectives

5 there was an article by Miranda --

6 DR. PEKAR: Right.

7 DR. KOSNETT: -- that was

8 performed here in North Carolina where they

9 looked at blood concentrations within 500

10 meters of an airport. These were, you know,

11 it was a study where they took old lead

12 sampling data and then they said who lives --

13 what children live close to an airport versus

14 live further away. And they saw a gradient,

15 a difference. And I'm just wondering, they

16 probably have air sampling at some of those

17 places and you know, there might be -- maybe

18 Dr. Miranda has that and that's the next study

19 that she hasn't yet published. But it might

20 be useful at least to even consider whether

21 those changes that she saw are at all in line

22 with what the modeling might predict. And you

Page 60

1 know, maybe that would help craft a new case

2 study. Since, as Phil said, it's a growing

3 concern as we're cutting back on other point

4 sources.

5 DR. PEKAR: I think that's a very

6 good point and I certainly have a big asterisk

7 now next to airports. I didn't read the

8 study, but I read some summary information on

9 it, an abstract, and I think that looking at

10 whether information associated with those

11 studies would allow us to further performance12 evaluate what we've done, whether, you know,

13 it's an issue of a case study, I appreciate

14 that and I think that's something that we

15 would need to address as part of the policy

16 assessment one way or another.

17 DR. FREY: Are there other

18 clarification questions for EPA? Yes.

19 DR. STUBBLEFIELD: I had a

20 question on the last slide in the whole deck

21 there associated with the approach, the

22 critical loads approach. You say in here that

Page 61

1 there is, to paraphrase, that there's not

2 enough new information that would change the

3 approach or improve on the HQ approach that

4 was used in the last review. I guess my

5 question is does that mean that the HQ

6 approach is what will be used in going

7 forward, or does that mean that there's

8 nothing new and so the conclusions are going

9 to be the same as from the last go-around?

10 DR. HUBBELL: Right, and it's the

11 latter for the most part in the sense that the

12 HQ analysis was based on concentrations that

13 have been measured around these different case

14 study areas compared against these benchmark

15 levels. And so that wouldn't change going

16 forward unless we had some dramatically

17 different and new measurement data that would

18 change our overall opinion. And, again, since

19 in the last review this was basically noted

20 that this was giving the potential for risk at

21 existing concentration levels, but we didn't

22 know how much of that was associated with a
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1 specific air quality standard, it's very

2 difficult to imagine that given that we've

3 changed the standard now we haven't had time

4 to actually see if there would actually be a

5 change in the risk, and so it wouldn't

6 actually change the information that would

7 inform the level of the standard that we would

8 be looking at.

9 DR. STUBBLEFIELD: At those

10 particular scenarios.

11 DR. HUBBELL: At those particular

12 scenarios, that's correct.

13 DR. STUBBLEFIELD: Okay, but what

14 about other scenarios because you've got an

15 entire ISA that we went through yesterday that

16 discussed the idea that there is causal

17 relationships between all of these endpoints

18 that were monitored.

19 DR. HUBBELL: Right and that

20 information, again, there was sufficient

21 information last time to determine that there

22 was ecological harm existing at the current

Page 63

1 concentrations, that hasn't changed. It's

2 just that we have, again, there's a difference

3 between the quantitative risk assessment and

4 whether that would actually inform evaluation

5 of alternative standard levels versus an

6 assessment of hazard.

7 I think the determination that

8 there's a hazard has been made, it's just a

9 question of whether you have additional

10 quantitative information from a risk

11 assessment that could allow you to

12 differentiate between levels or forms or other

13 aspects of the standard. And that's what

14 we're determining would not be informed by

15 anything new. Certainly the strength of the

16 evidence that would be evaluated in the policy

17 assessment may have been increased by the

18 additional information, but the ability again

19 to do quantitative differentiation based on

20 risk characterization, that hasn't really

21 changed.

22 DR. STUBBLEFIELD: So to flip it

Page 64

1 around in slight different words, if I

2 interpret what you said correctly then

3 basically the conclusion is that last time and

4 this time you're still concluding that there

5 are adverse effects associated with lead

6 concentrations, you just don't have the tools

7 to be able to assess the exposure side of it

8 and set a limit basically.

9 DR. HUBBELL: Yes, that's correct.

10 DR. STUBBLEFIELD: Okay.

11 DR. FREY: Okay. Any other

12 questions? Yes, Susan.

13 DR. KORRICK: I'm not a risk

14 assessor so if you can explain this to me in

15 very simple terms that would be very helpful. 

16 So, the point that changing information about

17 the variability for example in blood lead

18 distribution won't really help with the risk

19 assessment because understanding of source

20 apportionment particularly at the high end is

21 not very complete. I still don't understand,

22 if for some reason new data suggested that the

Page 65

1 GSD for blood lead in children was markedly

2 changed from what was in the previous model

3 wouldn't updating that information still

4 impact the quantitative component of your risk

5 assessment regardless of what's known about

6 interrelationships among source apportionments

7 for kids at the 95th percentile? I guess, it

8 seems to me that that's such a fundamental

9 part of what goes into the quantitative risk

10 assessment that if there's new information

11 that changes it it would still be of value. 

12 So I guess I'm not understanding something.

13 DR. PEKAR: No, no, I think that's

14 a fair question and you know, I think to be

15 clear when we say that, you know there's a

16 difference between rerunning the risk

17 assessment and talking even semi18 quantitatively about you know if a GSD is

19 different. Instead of having risk assessments

20 in this range they're now going to be in this

21 range. And we certainly I think would be in

22 a position to look at that kind of -- or to
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1 include that kind of information. So I think

2 what we're saying is that while we don't

3 believe it makes sense given the evidence to

4 restructure critical elements of the analysis,

5 it's not to say that we can't translate some

6 information like that into a meaningful

7 adjustment or sort of adjusted look at what

8 things might be. I guess the point that I

9 sort of harp on even from a couple of years

10 ago, I remember being -- I don't know if this

11 is the same room, I'm not sure that it was,

12 but just that pathway apportionment. You know

13 and as -- particularly as we started using

14 that information where management was

15 interacting with the risk information, our

16 inability to differentiate that pathway issue

17 was so critical. But your point is well

18 taken. You know, it would mean that the

19 absolute levels were different and we could

20 talk about that because you know that's

21 definitely something that's relatively easy to

22 translate. Once you have the geometric mean,

Page 67

1 that's the complex estimate to generate. 

2 Translating a GSD around that is a lesser

3 issue.

4 DR. KORRICK: So that's the kind

5 of information that will be included in the

6 discussion?

7 DR. PEKAR: Yes, definitely,

8 definitely. That's a good point. That's an

9 excellent example, thank you.

10 DR. KORRICK: Yes.

11 DR. PEKAR: Yes.

12 DR. FREY: Okay, Dr. Goodrum.

13 DR. GOODRUM: Yes, I've -- I've

14 had the opportunity to kind of talk about the

15 GSD concept for many years and in the

16 development of the IEUBK model and refinements

17 of the model and also the adult lead model. 

18 So and we'll talk about this more I think in

19 our site comments but I think the -- and I'll

20 submit some written comments as well. The

21 answer to how we use NHANES data and larger22 scale data to inform the risk assessment is

Page 68

1 that the variability that we would attribute

2 to data that we gather from larger populations

3 is going to reflect differences in exposure as

4 well as differences in individual factors that

5 determine uptake and bioavailability and all

6 the biokinetics. So it's a mixture of all of

7 those sources. And what we're really trying

8 to do in I think risk assessment and I would

9 strongly advocate this idea of setting up

10 different scenarios that we can use to then

11 make a judgment about overall population

12 impacts. What we're really trying to do is

13 hold fixed the concentration terms including

14 the background, however we define background,

15 whether it's diet or soil, and air. And what

16 we want the GSD term to reflect is the

17 variability in the population of children that

18 would be exposed to the same concentrations,

19 not the variability that is reflected by the

20 NHANES data which is the combination of

21 variability and individual activity patterns

22 as well as concentration. 

Page 69

1 So I'm not sure that for the

2 purposes of understanding exposures for -- and

3 risks to children I'm not sure that any

4 inferences really can be drawn from looking at

5 reports of NHANES-based changes in GSD. What

6 we really want and what might be helpful is on

7 a smaller scale to understand what's happening

8 on a community level for children that have

9 the same baseline exposures and then maybe an

10 airport scenario or what have you. 

11 But I guess long story short is

12 there's been a lot of work in the development

13 of the IEUBK to apply it in a way that

14 accommodates what you're trying to do which is

15 evaluate different scenarios, high-risk

16 scenarios, low-risk scenarios and use that to

17 kind of frame your decision, but not mix in

18 this information on GSDs from national scale

19 data. I don't know if that makes sense, but -

20 -

21 DR. PEKAR: Yes, just I think in

22 the previous risk assessment we talked
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1 probably not as elegantly as that, but sort of

2 about the GSDs you could get from different

3 populations, sizes, the fact that as it goes

4 to a small the GSD gets tighter because you're

5 reflecting biokinetic differences more than

6 say differences in age of housing and paint. 

7 So I think that's a good point.

8 So you know, I think looking to

9 you know considering the different sources of

10 GSDs, airport studies and other things to sort

11 of say do we have a better handle on isolating

12 this biokinetic factor. But even having said

13 that, that issue of looking at different

14 scenarios makes sense but if they become

15 hypothetical when we consider, you know, an

16 old house scenario mixed with sort of ambient

17 air levels you can certainly do it that way,

18 but you still are left with trying to define

19 pathway combinations, even for a geometric

20 mean estimate, you know, that are

21 representative and realistic. You know, an

22 old house may have certain water levels and

Page 71

1 soil levels and paint levels. Getting that

2 mix correct is not always easy with the data

3 that are available. So I guess that would be

4 my concern.

5 DR. GOODRUM: Okay. Absolutely

6 and I think your approach the way you just

7 described it is what I would support, that you

8 view these uncertainties as a way of

9 characterizing the range of geometric means. 

10 And that's basically your uncertainty

11 analysis, every scenario may give you a

12 different geometric mean, or within a given

13 scenario given the uncertainties you can frame

14 what that geometric mean range might be. And

15 then on top of that you apply the GSD to

16 generate your upper end estimates.

17 DR. FREY: Okay. Why don't we go

18 ahead with the discussion on the health risk

19 assessment issues and I propose to go in

20 reverse alphabetical order. So we'll start

21 with Dr. Weitzman. Oh okay. Well that's

22 fine. I mean, you can certainly pass and we

Page 72

1 can come back if you. Dr. Wasserman? 

2 DR. WASSERMAN: I have some small

3 things.

4 MR. YEOW: Can you use the

5 microphone?

6 DR. WASSERMAN: Sorry. Just some

7 small things. I think on page 212 when you

8 are discussing the four different models that

9 are offered, for those of us who read this who

10 are not statisticians perhaps the implications

11 or the -- I mean, a more user-friendly

12 rationale for what one model would portray as

13 opposed to the other would be helpful. And

14 also to clarify that the reason there is that

15 cut point in the Lanphear data is that I

16 believe there were insufficient observations

17 down there. So it wasn't arbitrary, it was

18 sort of data-driven. Let's see, what else. 

19 In terms of the table that lays

20 out the different areas for which there is and

21 is not data, it doesn't -- it doesn't always

22 match -- map easily onto chapter 2 from the

Page 73

1 ISA. In other words, there's a lot more

2 things for which causality can be demonstrated

3 than are reflected here. As I'm understanding

4 it, it's because you don't feel that you have

5 enough data. Even though there is the

6 suggestion of causality there's still a limit

7 on your ability to model. But that should --

8 just in case someone reads this and tries to

9 relate this back to or finds an inconsistency

10 there, just some more cross-talk between these

11 two documents would be helpful. And

12 everything else is minor in terms of

13 readability, but we don't need to do that now.

14 DR. FREY: Okay, great. Thanks. 

15 Dr. Von Lindern.

16 DR. von LINDERN: Good, I'm not up

17 against a deadline. 

18 (Laughter.)

19 DR. von LINDERN: I'd like figure

20 2.2, page 2-9 put up if possible. That will

21 speed me up. So this is a good flow chart of

22 the process, and the same process that was
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1 done last time. The problem is the top two

2 boxes didn't have decent data last time and

3 don't have any new data this time. So there's

4 really no reason to go ahead and do the rest

5 of this thing because it's going to turn out

6 the same. And the problem with that was last

7 time was probably not sufficient so this

8 time's not going to be sufficient either. 

9 Just a couple of places where you could look

10 to new information and be consistent are in

11 the dust soil lead relationships and in the

12 background concentrations for the IEUBK. I

13 think the TRW is working on that, you're

14 probably familiar with that and it would be

15 good to be cognizant of those concentrations. 

16 But I want to spend the rest of my

17 comments on a bit of history which is why I

18 wore my dinosaur tie today. 

19 (Laughter.)

20 DR. von LINDERN: Why are there no

21 data in those first two boxes? And lead is a

22 criteria pollutant and this agency has not

Page 75

1 collected risk-relevant air quality data for

2 20 years. That should be an embarrassment. 

3 And I think we need to look to history a

4 little bit to see why that happened and to see

5 that we begin to correct that now. This

6 committee met in 1982 to do the first 5-year

7 review of the lead standard and spent four

8 years turning out an excellent criteria

9 document. In fact, the 1986 criteria document

10 was extensively used in other programs to

11 effect cleanups in many media in this country. 

12 It was a valuable document. 

13 The next five years until 1991

14 were spent in CASAC and SAB working on a

15 recommendation for a new NAAQS and in 1991

16 that recommendation was made to reduce the

17 level from 1.5 to between 0.2 and 0.5. The

18 agency never acted on that and as a result

19 over the 1990s state implementation plans quit

20 monitoring and there has been no risk-relevant

21 monitoring conducted since that time. Now if

22 you look at those two top boxes up there,

Page 76

1 those are the statutory responsibility of the

2 EPA to collect that data. It's not to be

3 found in the ISIS, it's not to be found in the

4 air quality criteria documents, it's to be

5 produced by the agency in the air quality

6 programs. So that's not been done. It's

7 still not being done. And I would like to

8 hear from the agency when they are going to

9 begin to collect this information because this

10 is not the risk assessment we should be doing. 

11 The risk assessment we should be doing is

12 identifying how many children in this country

13 are living at, near or above this new air

14 quality standard. And we really have no idea. 

15 And that's where I would like to see this go. 

16 I think your hands are tied right now because

17 you've not collected the data to do anything

18 else but this and is there someone that can

19 respond to that? Because I'm going to say it

20 for the next four years.

21 DR. HUBBELL: I'd like to be the

22 one who's able to respond to that but that is

Page 77

1 not our role to determine the monitoring

2 strategy. That comes from a different part of

3 our organization. But there is going to be

4 some additional monitoring under the new

5 standards, but you're correct that a very

6 large nationwide increase in lead monitoring

7 is probably not on the horizon. But again, I

8 think that's something that if the panel wants

9 some information on that I'm sure that that

10 can be requested.

11 DR. von LINDERN: Thank you. And

12 then I'd like to point to one other thing that

13 Michael brought up and that's with relation to

14 Superfund sites. The same thing that happened

15 in air quality programs happened in Superfund

16 sites. Superfund goes through a process

17 called ARARs and I always get this acronym

18 wrong, but it's Applicable Regulations and

19 Appropriate Rules or the other way around,

20 whatever, ARAR. They are required to look at

21 whether they're complying with existing

22 standards, including the NAAQS. All of these
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1 sties had no trouble meeting the 1.5 so they

2 quit monitoring and they did not include in

3 their work compliance with the air quality

4 standards as part of their risk management

5 plan. But many, many of these sites were

6 above 0.15 and they have quit monitoring and

7 they indeed might not be in compliance with

8 NAAQS at this time. And there may be a number

9 of sites out there right now that there is

10 existing information in EPA's files to tell

11 them whether or not at least at the point at

12 which these sites quit monitoring were they at

13 excess risk due to air exposure.

14 DR. FREY: Okay. Well, thank you. 

15 I think this is a conundrum for the risk

16 assessment as you've pointed out. Well, next

17 on the list is Dr. Rabinowitz.

18 DR. RABINOWITZ: And I'm afraid --

19 well, I have only some really trivial things

20 to say after some of the more profound remarks

21 we've heard. A lot of them are just, oh,

22 maybe improved wording and that sort of thing

Page 79

1 which you're welcome to accept or not. I did

2 want to just bring your attention to one or

3 two little things. There's a figure I'd like

4 you to look at and I think it is on your page

5 2-5, figure 2.1. And I just was going to make

6 a suggestion on that. Perhaps it could be on

7 the screen. It's some box diagrams I think. 

8 Do I have the wrong page number? Okay. 

9 Anyhow, you'll see a series of boxes. Do I

10 have the wrong? Figure 2.1, I'm sorry. It's

11 a useful diagram and I just want to make a

12 little suggestion. If you look at the

13 internal deposition part, those three little

14 boxes, with a little effort you could re-label

15 the middle one Blood and label the one on the

16 left Bone and then you'd have blood where it

17 belongs as a central compartment. And you

18 could even put arrows, double-sided arrows

19 connecting them. It would just be helpful

20 like that. Although I think it's useful.

21 I also -- on section 2.1.2 I felt

22 the need for a table. There is already a

Page 80

1 table that lists the five studies in your

2 table 2.1 which is up there. Just for my ease

3 of reading I wonder if you could also present

4 a similar table but listing them by study, and

5 kind of a convoluted way of representing that,

6 a convolution of 2.1. Maybe show them both. 

7 It would just be easier reading for me. There

8 would be no new information, it would just be

9 easier to follow I thought. Hate to suggest

10 a new table. And the rest are trivial enough,

11 I'll just leave as the text. Thank you.

12 DR. FREY: Yes, thank you. I

13 guess this raises a point that partly just to

14 clarify in my own mind that this particular

15 document is -- I don't think we're going to

16 see a revision of this document, but I think

17 the comments you're making are important

18 because these figures and probably some of the

19 same text may appear in a later document such

20 as the policy assessment if not in REA. And

21 so I guess -- I guess it is appropriate to

22 make these comments in that spirit. But I

Page 81

1 just -- I wanted to just I guess dispel an

2 expectation if there is one that we would see

3 a revised methods plan because this is it for

4 the methods plan. 

5 DR. RABINOWITZ: Well, I just

6 mention just for the institutional --

7 DR. FREY: Yes, no, and as I say I

8 think it is valuable input to EPA because I'm

9 sure we'll see versions of these figures in

10 tables and text in other forms later. Okay. 

11 All right, great. Dr. Pounds?

12 DR. POUNDS: I say congratulations

13 on a very coherent document. I enjoyed

14 reading it and I have to say I'm embarrassed

15 that Michael picked up on that internal

16 deposition reordering of those boxes because

17 that's a -- and I missed it completely. I'm

18 so ashamed. 

19 (Laughter.)

20 DR. RABINOWITZ: I know you'll

21 recover quickly though.

22 DR. POUNDS: Actually I did see
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1 it, but you said it first. No, that's not

2 true. So I have several comments about

3 clarification of particular sentences. I'll

4 just provide those in my written comments. 

5 They're not sufficient to go over in this

6 session. But it was a coherent document.

7 DR. FREY: Okay, thank you. Dr.

8 Kosnett.

9 DR. KOSNETT: I agree it was a

10 nicely thought-out document and I concur with

11 the basic conclusion that there's not a basis

12 to do a new quantitative risk assessment, and

13 that the major predominant focus should

14 remain, you know, the relationship between the

15 air pathways and blood lead as they influence

16 IQ loss. And that's the bottom line, you

17 know, for what you want to say. The only

18 other comments I had was to reinforce what

19 Phil nicely said about the GSD from NHANES

20 being of limited utility in adjusting a

21 parameter in IEUBK which really focuses on

22 pharmacokinetic differences as opposed to

Page 83

1 exposure differences. 

2 And then the other thing and

3 perhaps it's potentially a bit more

4 substantive than those others is the point on

5 page 2-15 where you look at the bound between

6 what could be the low-end risk and the high7 end risk, that the low-end risk would be just

8 looking at the change in recent air and that

9 the high-end risk would be the change in past

10 air and recent air. But what's still missing

11 I think from the past, you know, from those

12 two together, the recent air and the past air,

13 is the change, and maybe it's a long-term

14 change on diet. And bear in mind, you know,

15 we discussed this a bit yesterday, that diet

16 is by far the predominant source of lead to

17 people in the United States today, by far.

18 On average, I mean the average

19 population. And so even a small percentage

20 change in diet could have a relatively

21 substantive change overall because -- so and

22 you know, I think we all know that one of the

Page 84

1 reasons blood lead went down 90 percent from

2 1980 to now is -- part of it you know is -- a

3 lot of it is the elimination of gasoline,

4 right? And how did the gasoline get into us? 

5 I mean, if we look at the parameters that Phil

6 showed yesterday on just the slope between air

7 and blood lead, right, maybe they were -- what

8 was it, Phil, for each microgram per cubic

9 meter maybe let's say three at the high end. 

10 Okay, so let's assume that back in

11 the late 1970s the national average was about

12 1.5, you know, micrograms per cubic meter. It

13 probably wasn't, that was probably in cities. 

14 So if you eliminate the air pathway, if it

15 went down -- away completely, blood lead would

16 have fallen by, what, two or three micrograms

17 per deciliter, right? Let's say if the air

18 levels in the 1970s were 1.5mcg per cubic

19 meter, and the slope is 2mcg per deciliter for

20 each one so we would have lost three, okay? 

21 But blood lead went from 15 to two. It didn't

22 go from 15 to 12, or 15 to 10. Some of it may

Page 85

1 be less paint around, okay, take a few points

2 off for that. You still see that most of --

3 where did the most of our big decline come

4 from? I think most of it came from the fact

5 that with less lead in gasoline coming into

6 the atmosphere a lot of it was that didn't get

7 into the food supply and the water and

8 everything else.

9 I mean some of it was dust, sure,

10 but adults don't get exposed to as much dust

11 and adults went down a tremendous amount. So

12 there really is an impact of that air pathway

13 on food and diet and it's not being captured

14 here. So I'm just wondering if in bounding

15 the changes you can somehow ponder it and we

16 can all think about it together, you know, how

17 we can say maybe the high-end you know

18 elimination, if 10 years, you know, let's just

19 say hypothetically we went from the 0.15

20 standard we are at now to 0.015, you know,

21 another order of magnitude, and I'm not

22 suggesting that, I'm just saying
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1 hypothetically. You know, 10 years from now

2 would ultimately we have less lead in food? 

3 I don't know, but I just thought it would be

4 something to consider because it looked like

5 a substantial impact of air reductions was on

6 food over the past 25 years. Does that?

7 DR. PEKAR: No, it does, yes.

8 DR. FREY: I guess this is on this

9 point? Dr. H. Allen.

10 DR. ALLEN: At the same time that

11 the air lead was decreasing because of the

12 change in gasoline there were a number of

13 other changes that were going on. We changed

14 the type of cans that we used for food. 

15 We no longer use lead-soldered

16 cans. We changed the toothpaste containers

17 that I had as a kid. You know, we did not

18 have plastic -- toothpaste did not come in

19 plastic tubes when I was a child. It came in

20 soft metal which had a lot of lead in it. 

21 Lead solder, including in the

22 little shop that I had you know and putting

Page 87

1 together radio parts and breathing all of that

2 in along with my stamp-collecting and the

3 carbon tet that I stuck my nose in, you know,

4 constantly for watermark detection you know

5 and all sorts of other wonderful things that

6 we used to do. 

7 So all of these were other

8 changes, so it's not just, I don't think just

9 the air and directly air to food that

10 contributed. I think there were a lot of

11 other contributions.

12 DR. FREY: Okay. Dr. Rabinowitz?

13 DR. RABINOWITZ: Yes, I just

14 wanted to speak to that same point, that

15 indeed the Ethyl Corporation and the other

16 people who made lead additives for fuels got

17 really nailed, deservedly so, for what they

18 did. They really identified that source by

19 isotopic methods and other methods, so we knew

20 how much lead enters people by direct

21 respiration.

22 Also we had some ideas how much

Page 88

1 lead entered the food chain by like fallout on

2 lettuce, things like that. Indeed, there was

3 a lot of that. 

4 But even back in 1975 and as it is

5 today most of us get most of our lead from the

6 diet. And the question is how much of that

7 lead in the diet came from automobile exhaust

8 and how much from the food processing

9 industry. And I think we've learned that

10 nearly -- a great deal of it was in the food

11 packaging industry. They've kind of escaped

12 notice, but if you go back to the literature

13 at the time and you see what the average FDA

14 diet was it used to be way over 100mcg a day

15 and now it's, well it's down in, I want to say

16 down in the dirt. Bad analogy.

17 (Laughter.)

18 DR. RABINOWITZ: The -- but even

19 at the time people were generating

20 electromicrographs of solder splash in food. 

21 You could take a can of string beans,

22 institutional size cans and there was solder. 

Page 89

1 You know, when you apply -- solder splash,

2 little particles of metallic lead in the food

3 back then. And that's all gone, that's all

4 history. So I just wanted to leave on that

5 one. Thank you. 

6 DR. FREY: Okay.

7 DR. RABINOWITZ: So you're right,

8 we have not seen that drop in blood only from

9 direct respiration, but there was a big change

10 in diet. Thank you.

11 DR. FREY: All right. Let's see,

12 Dr. Korrick.

13 DR. KORRICK: I agree, it's a very

14 clear, nicely done document. And I think

15 that, well, my main comments are probably more

16 ones of clarification. So indoor air

17 inhalation doesn't play a role in this

18 process, is that right? Am I understanding

19 correctly?

20 DR. PEKAR: No. We did inhalation

21 of ambient outdoor air and I want to say I

22 would have to clarify that. Deirdre, did we
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1 have an assumption about indoor versus out? 

2 Yes. So, while I led the risk assessment

3 Deirdre Murphy was critically important in

4 this too. We worked together on it. She's

5 reminding me that we did have an inhalation,

6 indoor inhalation with some transfer

7 assumptions? Yes, right. So yes, we did

8 consider indoor air inhalation.

9 DR. KORRICK: So, but it's just

10 not in any of the flow charts. Is it?

11 DR. PEKAR: Well you know

12 actually, yes. Let me take a look. 

13 DR. KORRICK: I mean, I know this

14 document is not going to be revised so maybe

15 it's a fine point, but I think if you

16 reproduce the flow chart so that it's in there

17 somewhere. I didn't see it.

18 DR. PEKAR: Right. I think

19 clarifying residential indoor air exposure and

20 how that was reflected.

21 DR. KORRICK: Which one?

22 DR. HUBBELL: Figure 2.1. There's

Page 91

1 a little box in the middle that says dust

2 indoors.

3 DR. KORRICK: Oh, oh, oh, okay. 

4 No, I guess -- well, in the other one, the

5 figure 2.2. So there's no -- in 2.2 it

6 doesn't translate into indoor air reflecting

7 outdoor air in the. 

8 DR. PEKAR: Yes, we should clarify

9 that.

10 DR. KORRICK: Yes, I guess this is

11 the one where I didn't see --

12 DR. PEKAR: In the mechanistic

13 modeling sort of layout.

14 DR. KORRICK: In this part, the

15 other part, yes I did see that.

16 DR. PEKAR: That's a good point.

17 DR. KORRICK: And when you do the

18 modeling you -- it looks like in the general

19 urban case study in the smelter study some of

20 the model assumptions, you put them at the

21 same exposure level. Is that correct?

22 DR. PEKAR: Well so the general

Page 92

1 urban study area, it's a scenario where you

2 have -- the outdoor ambient air level is at

3 the level of the standard. It's a little more

4 complicated than that because -- well, anyway. 

5 But then the primary lead smelter, the reality

6 there is we had two different exposure zones.

7 We had an exposure zone closer to the facility

8 where the ambient air levels were higher and

9 where we had different media concentration

10 data, and then we had an exposure zone further

11 from the facility. But the children nearer to

12 the facility were exposed very close to if not

13 at the ambient standard level.

14 DR. KORRICK: Okay. And as

15 another example of something that you would

16 include in your discussion of the existing

17 risk assessment, would that also include new

18 information about the relationship of dust

19 lead to blood lead for example? Because it

20 indicated that there was -- there's new

21 information about that, but not the full

22 pathway and that seems like another example

Page 93

1 where information could be used to sort of re2 parameterize uncertainties around the risk

3 model or whatever. I mean, is that something

4 you would do?

5 DR. PEKAR: And you said between

6 dust and blood?

7 DR. KORRICK: Yes, you indicate

8 that there was more data around dust and blood

9 but it wouldn't be relevant to redoing the

10 risk assessment. But isn't it relevant to

11 reinterpreting the risk assessment? Or no. 

12 DR. PEKAR: I'm just thinking --

13 DR. KORRICK: If like the

14 bioavailability of dust and lead is understood

15 differently than it was when you did the

16 original.

17 DR. PEKAR: Right, so one of the

18 critical things that the risk assessment

19 allowed us to do is we looked at the results

20 of the risk assessment and we said that you

21 can extract from this risk assessment -- we

22 did present this -- effectively air-to-blood
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1 relationships that were defined by the model. 

2 So it's going from air through these various

3 pathways to blood. 

4 DR. KORRICK: Right.

5 DR. PEKAR: And we looked at those

6 and compared those to the empirical air-to7 blood values that we used in the evidence

8 analysis as part of the rule review. So you

9 know, now if we have a relationship between

10 dust and blood that's sort of a sub-segment of

11 that which is in a sense hard to relate. So

12 I think we would talk about that, but the --

13 you know, I think that'd be something we'd

14 discuss, but as I think about it now it's not

15 something that's directly comparable to

16 elements of it because we never sort of

17 disentangled that out.

18 DR. KORRICK: You can't parse out

19 just a part of the pathway, okay.

20 DR. PEKAR: Right, that's right.

21 DR. KORRICK: And this is a minor

22 thing but just what are dual linear models? 

Page 95

1 Are these piecewise linear regressions?

2 DR. PEKAR: Yes, so what we did is

3 we had the full data set and Lanphear

4 published -- I mean, these were models that

5 were published where they fit two different

6 linear fits based on stratifying the

7 population at a certain break point in blood

8 lead. And I think it was either defined based

9 on the sample size -- I need to look at this

10 again, I'm just a little fuzzy -- or based on

11 where it looked like there might be a break. 

12 But you're essentially fitting a linear

13 function of the form to two different subsets.

14 DR. KORRICK: You're taking two

15 linear models and you're truncating the

16 distribution.

17 DR. PEKAR: Right.

18 DR. KORRICK: But how do you

19 decide the inflection point. Is that from

20 Lanphear?

21 DR. PEKAR: You know, and I need

22 to look at that again. Deirdre, do you

Page 96

1 remember? I'm fuzzy on that. 

2 DR. KORRICK: Because it'll make a

3 difference in the slope. I don't know how

4 much.

5 DR. MURPHY: It was really just

6 what the Lanphear paper did. He chose two

7 different break points. One was the 10 and I

8 believe the reason for 10 was because of the

9 CDC level at 10. And so he did if any kids

10 had a peak above 10 they were in one group or

11 below 10 they were in, you know. So that was

12 the break point. Then they took those and

13 modeled the linear. Then he then just picked

14 a lower number and he picked 7.5. He doesn't

15 provide a rationale for why he picked 7.5.

16 DR. KORRICK: I know that for the

17 truncation point, but that's not where the two

18 lines -- there's an inflection point where you

19 get two slopes and I just wondered where that

20 came from because it'll affect what you model.

21 DR. MURPHY: And what exactly are

22 you referring?

Page 97

1 DR. KORRICK: So you have two

2 lines that intersect at a given point and the

3 intersection point is not 10 or 7.5.

4 DR. MURPHY: Oh, in our figure.

5 DR. KORRICK: Yes.

6 DR. MURPHY: Because the

7 inflection point for him was the peak.

8 DR. KORRICK: So this also is from

9 Lanphear? Okay.

10 DR. MURPHY: It was peak blood and

11 these curves are concurrent.

12 DR. KORRICK: Okay.

13 DR. MURPHY: Sorry.

14 DR. PEKAR: No, that's a good

15 point.

16 DR. KORRICK: Okay. That's all.

17 DR. HUBBELL: And that's another

18 good example of a place where we'll clarify

19 that when we bring that to the --

20 DR. KORRICK: Yes.

21 DR. PEKAR: And as I read that I

22 was -- each one of these things is sort of
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1 technical rabbit holes and I'm always like how

2 far do we want to go down. I love going down

3 the rabbit holes but like in that point I knew

4 that there was a difference there and to be

5 fair, understandably it looks like there's

6 confusion in that so we'll put more detail. 

7 But that's always the challenge about how much

8 detail we get because then you need a little

9 more explanation to relate the concurrent to

10 the peak, how do you relate those, how do we

11 do this. So, but we can definitely clarify

12 that.

13 DR. KORRICK: All these details

14 are important to what you come up with in

15 terms of final risk, so yes.

16 DR. PEKAR: It is.

17 DR. KORRICK: Yes.

18 DR. FREY: Okay, thank you. Next

19 is Dr. Hopke.

20 DR. HOPKE: I pretty much said

21 what I'm going to say. I mean, again I think

22 we need to get a better, a much clearer view

Page 99

1 of what general aviation is doing. They fly

2 lower in altitude more often in the mixed

3 layer, you know. There are a lot more general

4 aviation airports than there are secondary

5 lead smelters and so in terms of a general

6 population exposure scenario I think we've got

7 -- somehow we've got to work in a clearer idea

8 and start to decide whether we can still allow

9 lead in aviation gasoline. 

10 You know, we have a clear

11 opportunity to remove a source which we say is

12 49 percent of the anthropogenic lead exposure

13 in the United States. It seems to me we've

14 got to start exploring whether that is

15 something that we need to start pressing for. 

16 I mean, we got rid of lead in motor fuels for

17 regular transportation. Is it really still

18 essential to expose a population in order for

19 general aviation to fly? It seems to me that

20 there's got to be ways that you can make 100-

21 octane avgas without lead and I think we need

22 to understand what the risks are for

Page 100

1 continuing to allow it to happen. 

2 DR. FREY: Okay. Dr. Hays?

3 DR. HAYS: I fear my comments are

4 more philosophical than specific, so. First,

5 I'd like to say thank you to Ian and Michael

6 for your historical perspectives on a lot of

7 these things. It's so valuable to hear these

8 concepts and as we were discussing last night,

9 the history of the CASAC committees and all,

10 it was just fascinating to hear these stories. 

11 And so much of this information isn't written

12 down. That's why it's really important to

13 have these old geezers on the panel with us.

14 (Laughter.)

15 DR. HAYS: Sorry, guys. You know

16 I love you. When we work on this lead rule

17 for air it just strikes me that you know we're

18 putting blinders on and looking at this whole

19 issue of lead being a multimedia contaminant

20 and we're only looking at a piece of the pie

21 here. And I want to just tell you a little

22 story about how Health Canada is doing their

Page 101

1 risk assessment, and maybe you're fully aware

2 of how they're doing it, but to me it makes a

3 lot more sense. 

4 What they've done is they've done

5 a risk assessment based on the dose response

6 modeling for IQ in children and then some

7 endpoints for adults to figure out what their

8 target blood lead level is going to be. And

9 they've picked 1mcg per deciliter as their

10 target. And -- absolute. Absolute level. 

11 Maybe -- I think they have two standards, one

12 for 1 and one for 2.5. They've got two

13 options they can go with. 

14 And then what they did is they

15 said okay, based on what we know about the

16 multimedia exposures associated with lead

17 we're going to allow 25 percent of that 1mcg

18 per deciliter to come from soil -- and I'm

19 making up these numbers, I don't know what the

20 exact fractions are -- 25 percent from water,

21 25 percent from air, 25 percent from diet, and

22 so on. They do these cut points. And I think
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1 air is actually a tiny portion of their actual

2 partitioning. And then it's up to the

3 respective departments who regulate those

4 various media to then figure out how they're

5 going to achieve that. And to me that makes

6 a lot of sense. 

7 We're using one risk assessment

8 approach to tackle a multimedia problem here. 

9 And I say that because we're all sitting here

10 dealing with air and you guys have done a risk

11 assessment for that. Some of us just have

12 been on the dust, what is it, repair and

13 remediation rule and we used a different risk

14 assessment approach. 

15 Michael was telling us about a

16 panel he did on lead in water and I don't know

17 what kind of risk assessment approach you guys

18 used for that, but it seems to me we've got,

19 you know, there's too much of a disconnect

20 within EPA on how lead is being handled and

21 how risks are being assessed. And so if you

22 could figure out a way to put the offices

Page 103

1 together and to build one panel to help give

2 you insights on how to do one multimedia risk

3 assessment, then you figure out how to divvy

4 up the relative proportions that would be the

5 way to go. So, if there's any way to achieve

6 that that would be wonderful.

7 With respect to your conclusions

8 about new data and the ability or need to

9 update the risk assessment, I agree with your

10 conclusions. There's just not enough new

11 data. It seems like just last year we

12 finished the previous lead CASAC, but

13 obviously I've missed a couple of years in my

14 life there so.

15 There just hasn't been enough data

16 that's come out. That doesn't mean you're

17 done, there's still needs, and so if I could

18 negotiate with you now, I'm going to pretend

19 to be an NFL owner and players here, I would

20 love to negotiate with you. And the

21 negotiation I would push for is now you -- you

22 just stop right now. Stop on your risk

Page 104

1 assessment, your REA, your ISA, you're done. 

2 Take what money you were

3 allocating for the next four years of paying

4 us, paying your contractors and so on. You

5 develop a research/data needs document that

6 would be the ideal experiments you would do to

7 fill these specific questions you've outlined

8 in this document and you have in this table. 

9 And you take that money and you pay for that

10 research, and we'll come back in five years

11 and we'll get all together again and we'll

12 move forward with something meaningful. So

13 that's it, that's my soapbox.

14 DR. HUBBELL: I will point out

15 that you know in the policy assessment part of

16 the work and as we move forward there is

17 usually a statement about research gaps,

18 limitations and needs in which these things

19 can be addressed, and those certainly are

20 things we'll take into account. And the other

21 thing I'll point out is that you -- I think

22 you may have a grossly inflated idea of how

Page 105

1 much money we have available to --

2 (Laughter.)

3 DR. HUBBELL: But again, I think

4 laying those research needs out and those are

5 -- if you have specific ideas about other

6 things we laid out as research -- as

7 uncertainties and critical gaps, if you have

8 ideas about ones that are specifically

9 important then sharing that is an important

10 part of what you can do.

11 DR. HAYS: Is there going to be a

12 period where we're going to review that

13 document, or do we just need to do that now in

14 these comments?

15 DR. HUBBELL: There's a review of

16 the policy assessment that occurs, and I think

17 there's two drafts? I've got it here

18 somewhere, but yes. There are two drafts and

19 a final policy assessment so you will have an

20 opportunity to comment on those particular

21 aspects of the work.

22 DR. HAYS: Okay. I'd as soon we
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1 not because I'd assume we'd be done and you

2 spend that money on other stuff. So I think

3 to the panel, if you have ideas like these

4 airport research projects let's send them in. 

5 Thank you.

6 DR. FREY: Yes, I guess the idea

7 of not having an REA and the first draft of

8 the policy assessment is the first time we'd

9 sort of see what substituted for the REA is --

10 I guess kind of puts that review of the risk

11 exposure aspects to the back end a little more

12 than we normally would. And I guess we're --

13 maybe there's some implications for the

14 scheduling of the policy assessment first

15 draft that might help deal with that. But if

16 that's sort of the first time that we see, you

17 know, what if any adjustments EPA is making in

18 its interpretation of what's already been done

19 in light of new information that tends to be

20 a little late in the process. Because usually

21 I guess in a more conventional review we would

22 have had an REA first draft in I guess sort of

Page 107

1 a cycle before we get to the first draft of

2 the policy assessment. So I guess just

3 process-wise it's a little bit of a concern

4 that I'll express. Yes.

5 DR. JOHNSON: Wouldn't the -- our

6 replacement for an REA be essentially a

7 summary of the findings of the previous REA

8 with that additional interpretation?

9 DR. FREY: Yes, but I guess the

10 additional interpretation we won't see until

11 the first draft of the policy assessment. And

12 then whether the panel views that as

13 sufficient. All I'm saying is that by not

14 having an REA we're kind of skipping a step

15 and that's one less review opportunity. So a

16 corollary of that is it is important to

17 provide as best we can today guidance and

18 feedback to EPA on what they should be doing

19 in interpreting the previous assessment if

20 that's something the panel is comfortable with

21 EPA's proposal that that's what they're

22 planning to do.

Page 108

1 DR. JOHNSON: Well, I guess what

2 I'm saying is an alternative would be to have

3 a document which isn't a new, you know, new

4 assessment but is a summary of the old

5 assessment with new interpretation which would

6 fill that spot in the process.

7 DR. FREY: Okay. Well, that's not

8 the proposal I heard from EPA but that sounds

9 like an alternative to have something that's

10 sort of like an REA in the process. It

11 wouldn't be a new quantitative assessment, but

12 it would be something that would be nominally

13 a placeholder for the REA that reinterprets

14 the previous assessment and maybe that's an

15 alternative review point for this panel.

16 DR. HUBBELL: And let me just

17 comment that, you know, the traditional way

18 the policy assessment does is it pulls forward

19 results of the risk and exposure assessment,

20 quantitative risk and exposure assessment and

21 then provides interpretation in the context of

22 evaluating the standards. That's essentially

Page 109

1 what we're talking about doing so it would be

2 taking a piece of the policy assessment and

3 moving it outside the policy assessment which

4 seems a little odd in terms of a way to do it,

5 but.

6 DR. FREY: Well, I guess that begs

7 the question what the outcome of this

8 consultation turns out to be in part, and

9 whether or not there should be -- and I

10 haven't heard anyone express this perhaps, or

11 I would like to clarify if some are, you know,

12 whether there should be some quantitative

13 sensitivity analyses or a quantitative avgas

14 case study or whether the panel is satisfied

15 that just reinterpretation is enough. 

16 So I guess in making comments it

17 helps if we can get an idea of where the panel

18 stands on that. Of course, a consultation is

19 not a review so we don't need to reach a

20 consensus, but I think you know some kind of

21 weight of opinion of the panel would probably

22 help EPA. Because it's not -- I guess I've
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1 heard different things. 

2 I've heard some people very

3 supportive that there is no need for further

4 updating of the previous quantitative

5 analysis, there's not enough new data, but

6 I've also heard some people argue, well, there

7 are some new things that aren't really

8 captured by the previous REA and it's not so

9 clear that that can be handled just through a

10 qualitative discussion. And so maybe as we

11 continue the discussion this morning we can

12 clarify those points. And Vanessa wanted to

13 raise some points too.

14 DR. VU: So Bryan and Zach, help

15 us out a little bit. If the panel is not

16 recommending the agency to develop an REA in

17 support of this review, then the information

18 would fold into the policy assessment. But

19 the schedule for the policy assessment is

20 always so close, the first draft is so close

21 to your proposed rule that by the time you

22 have a second draft there is not enough time

Page 111

1 that you can incorporate any other scientific

2 issues that this panel is going to look at the

3 first draft. 

4 So the question is I think I'm

5 hearing that -- I've got a feeling that the

6 group is fine if you fold some interpretation

7 into your PAD but as long as it's early

8 enough. So perhaps when you do the draft ISA,

9 the second draft ISA, if this panel is going

10 to meet and you have a first draft PAD I think

11 that gives us enough time. But I just don't

12 know whether your schedule in OAQPS allows you

13 to develop a draft policy assessment by the

14 time you have a second draft ISA. That's the

15 concern people having is how you interpret the

16 additional information qualitatively, vis-a17 vis the last round quantitative risk

18 assessment.

19 DR. HUBBELL: Yes, and we'll bring

20 that back and have a discussion about that,

21 but one of the concerns is that the policy

22 assessment has always been tied to the last

Page 112

1 draft of the ISA so we can have the full

2 weight of the CASAC committee in thinking

3 about how we should begin forming our policy

4 assessment. You know, right now it's -- the

5 final integrated science assessment is due

6 July 2012 and our first draft policy

7 assessment would be August 2012. So they're

8 very close to each other but there is you know

9 at least time to incorporate the result of the

10 last CASAC review. So you know, I think we'll

11 take this back and give it some consideration.

12 DR. VU: Yes, and my suggestion is

13 when this panel's going to reconvene a public

14 teleconference call in August if you --

15 September or August, I forgot what you guys

16 said. Early September. If you have enough

17 time and sort of inform this panel about your

18 schedule I think that would help the group a

19 little bit. It may well be the draft PA is

20 not going to be the same time as the review of

21 the second draft, but at least you know what

22 the schedule is.

Page 113

1 DR. HUBBELL: Okay. I think we

2 can come back and try to provide a little more

3 clarity on how, you know, if we decide not to

4 do a risk and exposure assessment document,

5 how that would play out in terms of the rest

6 of the schedule. And we can provide that.

7 DR. FREY: Yes, I guess my own

8 opinion is I would like the panel to have

9 enough time to review and provide feedback. 

10 And I think it's fine that this is an open

11 issue for now, but some consideration to

12 whether there could be a draft of some form,

13 whether it's called an REA or if it's early

14 partial draft of a PA that touches on these

15 interpretation questions and gives us a better

16 idea of where EPA is on that for concurrent

17 with the second draft ISA review I think would

18 be very helpful to this panel.

19 DR. HUBBELL: And another option

20 that we were just discussing is that you know

21 after the first draft policy assessment, right

22 now there's a fairly short amount of time
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1 between that document and the second draft

2 policy assessment and we could work on

3 extending that time period to allow for

4 sufficient review and modification based on

5 input we get from the panel.

6 DR. FREY: Okay.

7 DR. HUBBELL: So that's another

8 way we can do it.

9 DR. FREY: Yes. 

10 DR. HUBBELL: But we'll discuss

11 these and we certainly -- I'll mention it to

12 Lydia and we can work on it, and to Karen

13 Martin, and we'll work on -- provide a

14 schedule for you.

15 DR. FREY: Okay. Yes, Phil.

16 DR. HOPKE: Yes, I mean the

17 concern is that the major scenario in the old

18 document is the primary lead smelter which is

19 going out of business. So there's going to be

20 nothing in the existing base for the risk

21 assessment that is relevant to the situation

22 that will be in play after 2013. So you know,

Page 115

1 it seems to me that there's been a fairly

2 major gap, you know, they're not looking at

3 any of the secondary lead smelters, they're

4 not looking at avgas, they're not looking at

5 wheel weights, you know. So I'm concerned

6 that the old REA is really irrelevant to

7 informing the policy assessment going forward

8 into the future.

9 DR. FREY: I guess, Phil, to maybe

10 push you on that, what do you see as a path

11 forward?

12 DR. HOPKE: Well, I would think

13 that there ought to be at least some, you know

14 again, the major thing that's hanging out

15 there that I can see is the general aviation.

16 DR. FREY: Sure.

17 DR. HOPKE: Let's pick you know

18 maybe a couple of typical larger general

19 aviation airports and look to, you know, do

20 some simple modeling. I mean, we're not

21 talking about major efforts here, but at least

22 get some idea as to the distribution that

Page 116

1 we're likely to be seeing coming from that. 

2 These are going to be in small

3 particles, they're going to be widely

4 distributed at relatively low concentrations,

5 but we're getting to the point where we're

6 concerned about low concentrations. So at

7 least let's get some feeling for what the

8 magnitude of the problem is or isn't. And I

9 don't think we have that in hand at the

10 moment.

11 DR. FREY: Yes, I think -- and you

12 had said earlier about a screening analysis. 

13 You know, it would seem like one way forward

14 is to do a limited REA that does this kind of

15 screening, and if, you know, if you would

16 conclude that there isn't a sufficient basis

17 to even quantify to do the screening level, I

18 mean that's something you could bring forward

19 and we could review, or you might be able to

20 go through with the screening and show it's

21 above or below concern. 

22 If it's above concern maybe

Page 117

1 there's limitations where you cannot continue

2 to go forward quantitatively but it still

3 helps in qualitative input to the policy

4 assessment. I guess I'm a little

5 uncomfortable waiting till the first draft of

6 the policy assessment to see how that plays

7 out. And so as you think about how to go

8 forward in the next step, for this panel to

9 see something that is either a risk assessment

10 or the reinterpretation of the old assessment. 

11 I -- sooner is better I think for us. 

12 Michael, do you want to add to that?

13 DR. KOSNETT: I agree with that. 

14 If you can give us some near term feedback on

15 whether like a case study on aviation makes

16 sense. And you know, maybe -- maybe there's

17 some data out there like I said from the folks

18 in North Carolina who just did the blood

19 sampling. 

20 They might be able to crunch some

21 of the blood numbers next to some airport

22 monitors and just see how that relates. I
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1 mean, that would -- as I see it, the only

2 other potential thing you did, you had these

3 case studies you know that helped guide you. 

4 That was one you didn't use. That might be

5 one that's worthwhile.

6 DR. HUBBELL: We'll evaluate that

7 and try to get you some feedback on that. 

8 Again, if we talk about this at the August or

9 September teleconference we can give you a

10 quick update as to whether or not we think

11 there's sufficient data to move forward with

12 something like that.

13 DR. FREY: Yes. And that might

14 still leave you some money left over in your

15 huge budget for all the research that Dr. Hays

16 mentioned. Okay. Well, next on the list is

17 Dr. Goodrum.

18 DR. GOODRUM: Well, again, thank

19 you for a very readable document. I thought

20 it was well done. I think you know I would

21 agree based on your review of the literature

22 that's been presented since the last

Page 119

1 assessment that continuing with the risk

2 assessment approach is good. I would be

3 supportive of additional case studies. I

4 think that would be helpful. 

5 One comment I got thinking about,

6 and this may be part of the same budget

7 concern, but you made reference to the all

8 ages lead model and that caught my eye because

9 some of the data that we're not making use of,

10 you know, are some of the empirical

11 relationships that we have for older age

12 groups. 

13 I thought Dr. Cory-Slechta

14 yesterday made a very good point that we tend

15 to be overly focused on age groups of you know

16 children one to two to three years old but

17 it's also true that we can't lose focus on

18 older age groups that may be even more

19 strongly associated with long-term health

20 outcomes. And so the benefit of having a

21 single model that we can use to assess risks

22 through a lifetime rather than two separate

Page 120

1 models which we have right now and this would

2 go along with Sean's theme of streamlining

3 things a little bit in terms of our risk

4 assessment approach. 

5 But the all ages lead model which

6 has been reviewed and commented on and I'm not

7 sure what the status is now. Maybe you could

8 share, Zach or Bryan, for us what -- where

9 that is and how it plays into the timeline of

10 events here or if it does at all because I

11 would be in favor. That would also give us an

12 opportunity to revisit the GSD default which

13 is tied into for IEUBK work that was done to

14 verify the utility of the IEUBK model many

15 years ago now. And it's a concerted effort to

16 update that GSD in a way that's consistent

17 with the way we use these models. 

18 And so if we're moving towards

19 using an all ages model that would be again a

20 very important opportunity to revisit the GSD

21 with more current data. And that would allow

22 us to bring in some of the data that you

Page 121

1 identified for the older age groups. So

2 that's my soapbox, but the all ages lead model

3 I think would be a consideration that could be

4 helpful to bring in additional data. 

5 DR. FREY: Okay, great, thank you. 

6 Dr. Cory-Slechta. Oh, I'm sorry, yes. I

7 guess if there was a clarification. I didn't

8 mean to cut that off.

9 DR. HUBBELL: I'm actually going

10 to let Deirdre respond to that.

11 DR. MURPHY: I think we concur,

12 the all ages lead model would be a great

13 thing. It's still in development. That's

14 described in the ISA. So once we get there

15 that will be something that will come into our

16 stable so to speak of tools that might be

17 appropriate for this. 

18 DR. FREY: Okay.

19 DR. CORY-SLECHTA: I agree with a

20 lot of the comments that I've already heard

21 today. I thought the document was very

22 readable and agreed with its conclusions, but
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1 I also very much agree with what I've heard

2 this morning about the potential for

3 additional risk assessment case studies kinds

4 of things.

5 DR. FREY: Okay, thank you. Dr.

6 Canfield is not here so we'll go to George

7 Allen.

8 MR. ALLEN: Thank you, Chris. I'm

9 not used to batting cleanup here, but. A few

10 top of the comment remarks. First of all,

11 it's in general well-written and organized. 

12 Charge questions 1 and 3 have to me at least

13 brief answers. The question 1, the overview

14 of the previous REA and the NAAQS review are

15 adequate, certainly useful and for number 3 I

16 do agree with the decision or the suggestion

17 I guess to rely on the previous health risk

18 document for this round of the review. 

19 There's really not much or anything out there

20 that changes, significantly changes the

21 outcomes of the quantitative health risk

22 assessment. 

Page 123

1 A sidebar comment. I like HERO

2 when it works, but in this document there are

3 no HERO hot links. And while there aren't a

4 lot of references, there are -- there's still

5 a page full and that would be useful in the

6 rev to make it HERO-ized. I think, again,

7 it's a very, very, very powerful tool and very

8 useful for all of its purpose. I like it. 

9 I have a couple of issues that I

10 guess I must admit I'm confused on, and one is

11 the one that I asked about earlier and that's

12 the role of old soil lead and how it plays out

13 in the risk assessment. Section 2.1.1, page

14 2-2 says old soil lead is controllable. It

15 defines controllable and talks about the, you

16 know, it has the potential to be affected over

17 some time frame, that's the phrase used which

18 is of course fuzzy by an adjustment to the

19 lead NAAQS. And then -- and it also makes

20 further, you know, discussions in that

21 section. And then section I think it's 2.1.4,

22 I meant to write it down here, yes 2.1.4, page

Page 124

1 215, the REA document says as noted earlier

2 that the assessment did not simulate decreases

3 in the past air exposure pathways, quote, "ED

4 reductions in outdoor soil lead levels." And

5 yet it's considered controllable by the NAAQS

6 earlier. So I'm confused how those two are --

7 how they tie together.

8 DR. PEKAR: Sure. Yes, I think

9 what we we're saying is conceptually if you

10 adjust the NAAQS, so if you lowered ambient

11 levels of course we would expect to see some

12 effect on soil concentrations over time, but

13 given the structure of the risk assessment we

14 didn't quantitatively reflect that. So for

15 instance if we looked at in alternate lower

16 NAAQS like a 0.2 level which is one of the

17 scenarios we looked at, we ran a bunch of

18 lower scenarios, in presenting risk

19 information we would present the risk

20 reductions relative to either the current

21 standard or -- I mean, the current then

22 standard or current conditions and we would

Page 125

1 say that we would have understated the degree

2 of risk reductions because we didn't look at

3 the change in soil. So whereas we looked at

4 the changed inhalation in indoor dust

5 ingestion soil wasn't reflected, but we

6 certainly wanted to note that that's an

7 underestimate of the risk reduction because we

8 would expect to see conceptually some change.

9 MR. ALLEN: And that is noted,

10 that you know, you put upper and lower bounds

11 on the potential bias in the assessment. 

12 Okay, so yes, you could, but no, you didn't

13 kind of thing. Okay. That's good. It might

14 be helpful somewhere to include something that

15 clarifies that relationship. I got confused. 

16 And this whole concept of considering soil

17 lead controllable by the NAAQS, I talked with

18 a member of the previous lead review panel who

19 usually is very astute and careful and he

20 actually wasn't aware how the old soil lead

21 issue was handled. So it looks like it's

22 something that might have not been front and
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1 center. But so it maybe could be packaged in

2 one place how the soil lead, because that is

3 an important source and it's not going away. 

4 And I don't know if there's a way to summarize

5 that somewhere how in general it's handled

6 this way, this way, that way. That's a

7 suggestion.

8 Page 2-6 and 2-8 talk about

9 primary lead smelter exposures and we know

10 which one we're talking about. I assume a

11 very old primary smelter in Missouri. Now, in

12 the case study the -- essentially emissions

13 from that smelter are from combustion of the

14 mechanical sources, fine and coarse modes. 

15 The smelter has 550-foot stacks so little to

16 none of the stack emissions are going to

17 impact that 1.5km zone for the case study that

18 was modeled. 

19 But lead of any size or mode in

20 that zone is essentially all from putative

21 emissions, you know, regardless of the

22 combustion or otherwise. The REA says

Page 127

1 children's air-related exposures are most

2 impacted by emissions associated with a lead

3 smelter from which air concentrations were

4 estimated. So, the question is for emissions

5 used in this case study were total emissions

6 used, most of which are going up the stack and

7 not seen? Or were the emissions adjusted to

8 account for what is actually more likely to be

9 present within that 1.5km zone?

10 DR. PEKAR: Yes, the dispersion

11 model that was used at Herculaneum was

12 complicated. I mean, it included stack

13 emissions but also baghouses and inactivity

14 all around the site. I actually visited the

15 site which is a pretty interesting site to

16 visit, but it had, you know, I can't - it was

17 upwards of I want to say 50 or 60 processes

18 that were modeled. It was a large -- and they

19 even had the truck transport I believe. It

20 may have been outside of the facility. 

21 Certainly truck transport within the facility. 

22 So it was pretty a comprehensive modeling

Page 128

1 effort.

2 MR. ALLEN: Okay. So it didn't --

3 it did not simply assume stack emissions?

4 DR. PEKAR: No.

5 MR. ALLEN: Because there is, you

6 know, you can model the dispersion but they're

7 not going to -- 550-foot --

8 DR. PEKAR: Yes.

9 MR. ALLEN: They're never going to

10 mix down in the first 1.5km.

11 DR. PEKAR: Right.

12 MR. ALLEN: So that was --

13 DR. PEKAR: Yes.

14 MR. ALLEN: Okay, that's good. 

15 Some other minor comments. I agree with Dr.

16 Hays' comment on the Canadian model, I like

17 the way they do things, but since the Clean

18 Air Act we're kind of stuck with a single

19 media approach. It's what we have to work

20 with similar to the NOx/SOx process. It's

21 difficult and introduces uncertainties that

22 otherwise could be avoided but it's what we

Page 129

1 have. In terms of the general aviation lead

2 avgas issue, it's interesting, it's actually

3 a little -- it's unknown in terms of how much

4 of that really does impact population. 

5 However, it should be noted just for the panel

6 in general that EPA does have -- they're

7 putting in a pilot study, that's a bad pun,

8 not to study pilots but --

9 (Laughter.)

10 MR. ALLEN: -- but to study on a

11 pilot-level to put out measurements at 15

12 general aviation airports between a half and

13 one ton. That's being put in place now,

14 should be running soon, certainly before the

15 end of the year. That plus the other few

16 airports that are over one ton we'll have data

17 from 20 or so GA airports a year or so from

18 now which might really help to inform the

19 process in terms of what these exposures are

20 like. Then of course the question of siting

21 is critical. Where you put that monitor, you

22 move it you know 50 meters it could make a big
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1 difference. And my understanding is OTAQ

2 wanted them, you know, the highest point of

3 exposure on the airport itself, on the tarmac,

4 but what's happening is that airport managers

5 are saying no, you can't go there, you're off

6 to the side. That's just, you know, the

7 closest they can get. So that will reduce the

8 numbers from what I think was originally

9 intended. However, it might be a better

10 indicator of what is really going on. So

11 that's something people should be aware of. 

12 It will be available during the process of

13 this review cycle before we get to the end. 

14 I think that's it.

15 DR. FREY: Okay. Any other quick

16 comments before we take a short break? Notice

17 how I set that up. Who wants to get between

18 us and a break.

19 (Laughter.)

20 DR. FREY: Okay. Let's take a 10-

21 minute break and we'll start again at 10:50.

22 (Whereupon, the foregoing matter

Page 131

1 went off the record at 10:40 a.m. and resumed

2 at 10:55 a.m.)

3 DR. FREY: Okay, so we're going to

4 talk now about the welfare risk assessment

5 issues and some of the questions are up on the

6 screen. And I think this time we'll go in

7 alphabetical order. So we'll start with Dr.

8 Herb Allen.

9 DR. ALLEN: And here I was

10 planning on being last. I have two comments

11 relative to the document. The first one is

12 the references in the document to the ISA and

13 the location of the points was exceedingly

14 helpful. This should be told to other people

15 when they write summaries or refer to

16 documents. That really made life easy. You

17 knew where things came from and you could

18 check if you wanted to, so congratulations on

19 that. The second one is I have no comments. 

20 I thought it was fine.

21 DR. FREY: Okay, thank you.

22 DR. ALLEN: We could quibble but I

Page 132

1 don't feel like quibbling.

2 DR. FREY: Okay. Rich?

3 MR. POIROT: What happened to

4 alphabetical order?

5 DR. FREY: Oh, I'm sorry, you're

6 right. I just saw you.

7 (Laughter.)

8 MR. POIROT: I don't mind. I

9 don't have much to say so we can get --

10 either. So we can get rid of me quickly. I

11 agree with the previous comments, folks

12 talking about the health version of this

13 document, that it was just really clearly

14 written and that's always a pleasure. And so

15 kudos for that. I generally have no

16 objections to the overall concept of you know

17 using the new information to reinterpret the

18 risk assessment that was done previously as

19 opposed to conducting a new one overall. 

20 I had one sort of minor

21 observation or suggestion. I note that one

22 area where a lot of new information is noted

Page 133

1 has to do with the nature and transport

2 mechanisms and so forth of lead and soils and

3 sediments in particular with the

4 bioavailability being greater in sediments

5 it's observed for example. Other, better

6 information on transport and resuspension

7 processes of lead from sediments to the water

8 column and so on and so forth along with

9 better detail on amounts and particle size

10 distributions. 

11 And it just occurred to me that --

12 maybe this is a little bit local and

13 parochial, but we had some really severe

14 flooding in Vermont this spring. Lake

15 Champlain reached a historical record level

16 never in modern times seen before. The

17 several miles of highway between our capital

18 city in Montpelier and the Granite Capital of

19 the Northeast Barre was inundated with

20 floodwaters which were full of sediments from

21 deposited historically perhaps in upstream

22 areas along roadsides, and there was this
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1 whole redistribution. 

2 And unfortunately we had no air

3 monitoring going on in that area, but

4 anecdotal reports were -- and you could see on

5 news reports it was just extremely dusty when

6 those flood-deposited sediments on roadways

7 and parking lots dried out and were re8 disturbed by moving traffic and so forth. 

9 I noted also there's been some

10 detailed looks for example by USGS and EPA but

11 especially USGS in terms of sediment

12 redistribution and lead content in New Orleans

13 post-Katrina and very high concentrations of

14 lead. And anyway, it just occurred to me that

15 it's a mechanism by which this large reservoir

16 of historically deposited old lead can and

17 does become new lead. And we weren't the only

18 place that experienced record levels of

19 flooding and so forth this year, that was

20 widespread throughout large sections of the

21 country. I don't know if there's more coming,

22 but it just occurred to me as a mechanism that

Page 135

1 you might look at in interpreting the

2 currently available risk assessment

3 information in terms of a new way to get old

4 lead into the air and redistributed that way

5 again. So that was my only comment. 

6 Otherwise I thought it was really well done.

7 DR. FREY: Okay, thank you. Dr.

8 Davidson.

9 DR. DAVIDSON: Gee, I thought it

10 was off the hook for a minute there. So I

11 liked the overall document. I thought that it

12 was very well put together, clearly written. 

13 I have some minor comments that I'll submit in

14 writing. I've got just one general point that

15 I'd like to make. I think that there is a big

16 difference between looking at this document in

17 terms of the health risks versus looking at

18 this document in terms of the ecosystem risks. 

19 And I'm not sure if this point comes across in

20 the document right now, but in fact you know

21 when I think about a risk assessment based on

22 say something like IQ deficit, lead exposure

Page 136

1 is certainly one of the things that comes to

2 mind in terms of all of the different things

3 that might cause IQ deficits. I think that

4 lead is an important actor. On the other

5 hand, this document talks about ecosystem

6 services and talks about the fact that lead

7 can influence the functioning of ecosystems

8 and that could affect ecosystem services. If

9 someone were to ask me rank order the various

10 things that might be responsible that people

11 are doing that would reduce the functioning of

12 ecosystems and the production of ecosystem

13 services where would lead be on that list? I

14 don't think it would be up top. So I think

15 that there's just a huge difference in terms

16 of the perspective of the importance of lead

17 in the health risk assessment versus the

18 ecological risk assessment. And anyway,

19 that's the only comment that I think I'd like

20 to make.

21 DR. FREY: Okay, thank you. Dr.

22 Johnson?

Page 137

1 DR. JOHNSON: I guess the only --

2 well first of all, I completely agree with

3 what Cliff just said. The only thing I would

4 add to the discussion that we've had this

5 morning about this document is that the -- I

6 agree with the final, final thing on the

7 presentation which said that critical loads,

8 the critical loads approach is probably the

9 way to go in terms of doing a meaningful

10 ecological risk assessment for terrestrial

11 systems at least, aquatic systems perhaps as

12 well. And you know, and I like the fact that

13 they said that's the way they want to go in

14 the future. But at the same time you know

15 there's a reality here. In the planning

16 document they say the following, "However,

17 application of this methodology at a national

18 scale requires localized data across a wide

19 range of ecosystems which are currently

20 unavailable or inadequate," so basically

21 saying that we can't really apply a critical

22 loads-type approach at the present time
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1 because of data needs and in the presentation

2 they mention the fluxes in particular. 

3 Well, if the ISA that we looked at

4 yesterday is to be believed there is no data

5 in the United States of America anywhere for

6 fluxes of lead in precipitation. I don't know

7 that -- I don't think that's true, but at

8 least if you look at the ISA it would seem to

9 be true. Also there's no data in the United

10 States of America for fluxes of lead in

11 running waters. Again, I'm not sure that

12 that's really true but if you look at the ISA

13 it would appear to be true. 

14 So you know, while it's nice to

15 say well, this critical loads approach is the

16 way to go, it's what we're going to do in the

17 future, it's very hard to imagine any point in

18 the near or distant future at which the data

19 availability for some of these key fluxes that

20 would be needed to do a critical loads

21 assessment will ever really be available for

22 such an assessment for lead anyway in the U.S. 

Page 139

1 So this kind of touches upon what Ian was

2 talking about before. I'm not sure that these

3 are statutory responsibilities of the EPA,

4 they probably are not, but we just -- we're

5 just in the environment right now where

6 there's not the funding for the kind of data

7 collection that would be necessary to do what

8 the EPA would like to do in terms of this type

9 of an approach. So that's all I have.

10 DR. FREY: Okay, thank you. Dr.

11 Lanno?

12 DR. LANNO: I thought it was a

13 fairly nicely put together document and I

14 think Cliff made a great point about where

15 lead would rank on, you know, as a risk factor

16 determining what goes on in ecological

17 systems. And Chris made a good point about

18 fluxes and deposition rates. And if we don't

19 have a deposition rate that we can look at

20 loading rates of lead to these systems it

21 really -- any new data that we have that Dr.

22 Stubblefield talked about yesterday from the

Page 140

1 European REACH program that I think is

2 sediment and aquatic data and the soil data

3 that will be available, that's kind of what we

4 can use to assess what happens after the lead

5 gets there, but we have to know what that rate

6 is. And I guess that comes from developing

7 critical loading models as Dr. Allen was

8 saying earlier. And without that I'm not sure

9 we can make anymore, any different decisions

10 than you made here. So.

11 DR. FREY: Okay. Dr.

12 Stubblefield?

13 DR. STUBBLEFIELD: I'll reiterate

14 what all of my colleagues said in terms of the

15 fact that I thought that the document was well

16 written and it was easy to follow and I

17 certainly appreciate that. I always like

18 reading documents like that, it makes my life

19 easier.

20 I come at the end here and so I

21 will ask -- throw out a couple of questions

22 and they've been alluded to by Dr. Johnson and

Page 141

1 Lanno. When we typically do an ecological

2 risk assessment we compare media

3 concentrations to concentrations that we know

4 cause adverse effects. And I think the ISA

5 document does a very good job of going through

6 the available information with regard to

7 effects. And we know that there's some

8 issues, and we know that there's some things

9 that we want to take into consideration, and

10 we want to update as far as effects

11 concentrations go and what are acceptable and

12 what aren't acceptable. 

13 But that said, risk assessment

14 involves an estimate of exposure as well as

15 the effects evaluation. And as we look at the

16 approach that has been taken, I can't

17 remember, the figure 3.2 was the first thing

18 that kind of grabbed me. And what I noticed

19 there is that you've gone through and you've

20 estimated, or you've taken empirical data for

21 various media concentrations, sediments,

22 soils, water, et cetera. But nowhere in that
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1 evaluation with the exception of the secondary

2 smelter case study did you try to take a media

3 concentration and move it to an atmospheric

4 concentration. And that's what this is all

5 about as I understand it. 

6 So I am not an air modeler in any

7 way, shape or form, and I don't know how to

8 get from air to sediment or to soils or to

9 water concentrations. I am familiar with once

10 things get into water how we go about

11 apportioning their distribution and there's an

12 effort called the unit world model that Kevin

13 Harlow and several of the folks at Manhattan

14 College have been involved in, and it is

15 looking at, okay, where do things go, metals

16 in particular, where do they partition once

17 they get into that media. But the problem is

18 I don't know how to get from the air to those

19 media. I can't help but think that probably

20 there must be some old-time modeling data, if

21 there's some old guys who remember you know. 

22 I can't help but think that during the Cold

Page 143

1 War years we were wondering about well you

2 know, where's radionuclides going to go and

3 how do they you know drop out and how do they

4 apportion to soils, et cetera. I mean, there

5 must be a bunch of that kind of modeling but

6 I know nothing about it. 

7 So it strikes me in this whole

8 effort that the weak link in the entire

9 program is how we get those air

10 concentrations. And so if there is not an

11 effort to try to identify how to address that

12 then I don't know that we'll ever be able to

13 get to where we need to be in evaluating air

14 concentrations with lead. I'll just leave it

15 there.

16 DR. FREY: Okay. Thank you. 

17 Other comments? Any member of the panel. So

18 we've said all we need to say. Okay. Well,

19 thank you to EPA on presenting and discussing

20 with us on the methods for the REA. And in

21 terms of the panel member role since this is

22 a consultation you would have the opportunity

Page 144

1 to revise your individual comments and those

2 will be conveyed with essentially a cover

3 letter to the administrator, but we're not

4 charged with developing a consensus report on

5 the consultation. So in that sense it's a

6 simpler process than what we went through

7 yesterday. 

8 Any last thoughts about the REA? 

9 What I'd like to do is come back actually to

10 the ISA and talk a little bit about the panel

11 consensus on some of the main points which

12 I've attempted to summarize. But before I do

13 that I just want to give any last chance if

14 there's anything else on the REA. If not --

15 I don't see any. Okay. All right.

16 Well, Aaron has emailed to all

17 members of the panel a draft of kind of main

18 points that would go in a letter to the

19 administrator. And what I'd like to do with

20 the time we have and maybe we can finish a

21 little early possibly is go through this in

22 terms of the content, maybe if we can try to

Page 145

1 refrain from wordsmithing. 

2 What I most want to get out of

3 this is just an idea of what are the main

4 points that need to go to the administrator

5 via the letter and you know, if you see things

6 here that are not important points that you

7 think don't belong there, or if you see things

8 that are missing that you think belong there,

9 or if you support what's in there, those are

10 the things I'm most interested in getting

11 feedback on. Of course, there's also the

12 response to charge questions which I don't

13 think we have time to go through that and so

14 I didn't even want to attempt to try to do

15 that in the time we have left, but that's also

16 been emailed to everybody. 

17 And as we talked about at the

18 beginning of the morning, individual panel

19 members who are assigned to a charge question

20 should provide input to the leads on the

21 charge questions. The leads should take that

22 input and make revisions as appropriate to
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1 those responses and within about two weeks

2 we'd like to have those final drafts on the

3 charge question responses. And then Aaron

4 will schedule a teleconference probably for

5 late August. He has to give notice through

6 the Federal Register which is why it takes

7 awhile to actually get that conference

8 scheduled. And then we'll have an opportunity

9 as a panel on the phone to go through both the

10 charge question responses and the revision on

11 the letter that I'll work on.

12 So maybe what I could do is kind

13 of walk you through the letter to give you an

14 overview of what's in it and then we could

15 come back maybe on a sort of paragraph by

16 paragraph basis and just see, you know, what

17 our comfort level is with the points raised or

18 what's missing. So this first paragraph is

19 meant to be a general, these are general

20 points. One is that you know -- and also

21 somewhat responding to the first charge

22 question. So the panel seemed reasonably

Page 147

1 happy choosing studies within about an order

2 of magnitude of current exposure levels. 

3 People seemed to like HERO. A general comment

4 we heard over and over again I think is the

5 ISA really needs to have summaries of the

6 state of science as it existed prior to this

7 review, and then a more critical evaluation of

8 literature and conclusions about what's been

9 learned since the last review. And I think

10 generally the framework for causal

11 determination is pretty well accepted but

12 there were some comments, and this came out in

13 some of the other charge questions, but I

14 think it came out in more than one place, so

15 I thought this was a general point, that

16 there's a need for more consistency in the

17 rigorousness and the transparency with which

18 those are applied.

19 Another point that came up in I

20 think more than one place is it would help if

21 the ISA would address not just here's a list

22 of what the endpoints are, but what's their

Page 148

1 relative magnitude or importance. There was

2 also I think a number of instances where

3 although the ISA cites studies and seems to

4 summarize what the author said about the

5 studies, the ISA did not critically evaluate

6 the studies and in some cases either

7 misinterpreted or misapplied the studies. And

8 so clearly that's something that has to be

9 addressed systematically in the document. And

10 that relates to a critical evaluation of the

11 literature and gives some perspective on the

12 relevance as well as limitations of the

13 literature.

14 Now, I put a sentence here which

15 I'm not sure belongs in this paragraph, but

16 there was a number of times we talked about

17 you know gender differences and age effects

18 and maybe that -- well, we can discuss where

19 that goes. But it seemed like I don't know if

20 that's a general thematic point or maybe it's

21 a more specific point for later. 

22 The next paragraph is just kind of

Page 149

1 saying well, we kind of like chapter 2, it

2 seems to be at about the right place, it's,

3 you know, and I think if EPA wants to revise

4 it to combine with chapter 1 there was support

5 for that. I didn't necessarily want to put

6 too much detail in the letter, but maybe it

7 should be said here too, that EPA's proposal

8 seemed to have support from the committee. 

9 But there was a need for more balance and

10 consistency within the ISA chapter 2 and

11 linkages to other parts of the ISA. 

12 The third paragraph gets into the

13 issue of monitoring and this is -- last night

14 I looked back at some of the previous letters

15 from CASAC to the administrator. This is

16 something that has been addressed over and

17 over and over again by this panel, its

18 predecessors, by the statutory CASAC and so

19 that's why I started with the reference to the

20 2008 comments, that there's some history here

21 it's probably worth reminding the

22 administrator of. And you know, the bottom
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1 line is CASAC has recommended a transition to

2 a different kind of ambient monitoring method

3 rather than the high-volume sampler and that

4 hasn't seemed to happen. We've heard specific

5 panel members touch on that. So I think

6 that's an important point to bring out in the

7 letter. I think in terms of the ISA the point

8 is the ISA should do more to address the

9 science related to that. And also we heard

10 about errors in measurements that confound

11 attempts to compare lead in different particle

12 size ranges, and that seemed to come up

13 several times.

14 The next paragraph gets into

15 issues of the inventory and I kind of mixed in

16 inventory, air quality and exposure. So the

17 general ideas here are that we need a more

18 critical evaluation of the inventory including

19 trends over time. And I made a note about

20 anticipated trends. That's kind of an

21 implicit reference to things like, you know,

22 tire wheel balance made of lead and phasing

Page 151

1 out of our remaining smelters and this type of

2 thing, the precision and accuracy of the

3 inventory, the relevance of different sources

4 to human exposure. 

5 We also have heard some discussion

6 about policy-relevant background and I think

7 if I caught all the charge question responses

8 this may not have come up so much in the

9 charge question responses as yet and so in

10 revising the charge questions, particularly

11 for chapter 3 and maybe 4 this may be an issue

12 that needs to be considered by the

13 discussants. Because I think we've heard this

14 and we heard it again today about the need to

15 quantify a policy-relevant background. 

16 And one suggestion was to use

17 improved sites. Maybe that detail doesn't

18 need to be in the letter, but just the general

19 point about policy-relevant background, and

20 also the point about transcontinental

21 transport of dust from Asia and its possible

22 impact on -- well, from even just a scientific

Page 152

1 characterization point of view. 

2 Another point that was made in the

3 discussion but I'm not sure I saw it reflected

4 in the responses to the charge questions is

5 that the ISA should do more to review the

6 state of science in exposure measurements and

7 modeling, including multi-pathway exposure. 

8 And even more specifically the, you know, the

9 science behind the models that EPA is using or

10 potentially could be using. And so I put a

11 sentence in that even though right now I don't

12 think it's really discussed in a charge

13 question but probably should be.

14 The next paragraph. So the ISA

15 should provide a critical review of the

16 contribution of ambient lead to blood levels

17 and whether that varies with other factors. 

18 Now this, I actually wrote this paragraph

19 probably a little before I got some of the

20 charge question responses and so this one is

21 probably, well you know, may be more in need

22 of input. So, then we had some discussion

Page 153

1 about using models to provide insight

2 regarding how blood levels vary and that there

3 was some discussion about preference for using

4 empirical data, or if models are used to

5 evaluate or describe the evaluation of those

6 models and the basis and limitations of the

7 models need to be more clear. 

8 Moving on to the next paragraph,

9 biomarkers may represent recent exposures or

10 long-term exposures and I think some were

11 saying that distinction wasn't very clear in

12 the ISA or it needed to be brought out more. 

13 And so some comparisons of empirical data

14 might inform that assessment. The ISA

15 includes some studies recently that look at

16 slope factors for ratios of air and blood

17 lead. There were some very -- in the charge

18 question response there's more detail on this,

19 there's some nice suggestions for how to

20 improve that and I just tried to put in a

21 couple of sentences here that touch on that,

22 ways to compare the slope factors graphically
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1 for example. 

2 If we go to the next paragraph,

3 this deals with mode of action. And my

4 interpretation was the comments were the ISA

5 does a generally decent job on mode of action

6 but there were some areas where more

7 consistency was needed between the science and

8 what the conclusions were about the science. 

9 One example was oxidative stress. Differences

10 in potency or severity of effects should be

11 discussed. That kind of relates to what was

12 stated in the first paragraph as well about

13 generally just the need for more comparison of

14 the magnitude of effects where it's possible

15 to do that. 

16 Another point and I'm not a health

17 expert so this is my interpretation was that

18 care needed to be taken in attributing

19 outcomes as if they were based on current

20 blood levels versus maybe they had something

21 to do prior burdens. 

22 And then there was a need for more

Page 155

1 discussion of the significance of effect sizes

2 and whether it's from a clinical perspective

3 or maybe some other perspective. It may be

4 the ISA should lay out what those perspectives

5 are and so that would be helpful.

6 Moving on then, there's a need for

7 more integration of health effects, or more

8 integration of cross-health effects. So for

9 example, are there some relationships between

10 -- I use the word "medical," I don't know if

11 that's the right term, but medical versus

12 behavioral outcomes. Confounders, we had some

13 discussion about that and it seems like

14 there's a need that they be more consistently

15 and appropriately addressed. There was a

16 concern several people had about the

17 classification of some endpoints that are not

18 actually neurological that should be described

19 more appropriately. There is I guess a need

20 for more prioritization or evaluation of the

21 review of the epi studies rather than just

22 sort of a laundry list or a core dump. And,

Page 156

1 but a corollary of that is because some of the

2 effect estimates that we might infer come from

3 only one study there's a need for discussion

4 of how robust and reproducible those insights

5 are. Let's see. 

6 And then we had a lot of

7 discussion about parities between human and

8 animal studies and so that should have more

9 discussion. And I think I understood we also

10 were talking about maybe more discussion of

11 temporal patterns in exposures and effects

12 processes. Two more paragraphs to go. 

13 So additional discussion of

14 susceptibility factors -- so this relates, if

15 I'm remembering correctly this is charge

16 question 6 more or less -- is recommended. 

17 And I listed some examples, housing type,

18 gender, nutrition and others. And sort of a

19 similar point and maybe it doesn't need to be

20 stated twice about effect modifiers from a

21 single study might lack sufficient weight of

22 evidence. There was also some discussion that

Page 157

1 the document focuses a lot on early

2 development adverse endpoints, but that later

3 periods in life are also important and so that

4 context needs to be readjusted I guess. And

5 then the last sentence there, I don't know if

6 we need that sentence. I defer to the health

7 experts about maybe we don't need to say that.

8 The last paragraph is dealing with

9 the welfare effects. As I understood the

10 discussion it seemed like a lot of data that

11 EPA would rely on is from prior to 2006 but

12 that there's potentially a lot of useful data

13 generated under the European REACH program

14 that EPA should review. The organization of

15 the chapter by terrestrial and aquatic

16 environments is useful. I heard comments

17 though that it would be good to distinguish

18 marine and freshwater, and also that it would

19 be good not to lose the linkage between

20 terrestrial and freshwater systems such as

21 related to watershed and runoff. There was

22 some discussion that bio-accumulation is
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1 described in the ISA as an adverse effect, but

2 it's also an ecosystem service and so that

3 needs to be clarified. There were -- well,

4 significant discussion on bio-concentration

5 factors that -- and I don't know what the

6 right way of -- I was trying to be a bit

7 diplomatic, but you know, are not typically

8 recommended for application to metals. But as

9 I understood the response to the charge

10 question I didn't infer that the panel was

11 saying they shouldn't be used, but that if

12 they are used they should be used more

13 critically. And if that's not the case you

14 know we should clarify that.

15 The ISA as I understood the panel

16 remarks, the ISA kind of said well, you know,

17 there hasn't really been much new and critical

18 loads, but I guess what has been new is the

19 emergence of some data that might help do such

20 an analysis and that could be discussed. 

21 There was also some discussion and you know

22 again I defer to the experts on this, but that

Page 159

1 the selection of outcomes for ecosystems might

2 at least be discussed in a different way in

3 the ISA, taking into account things like

4 population, the community and maybe

5 functionality rather than focusing on

6 surrogate indicators such as a biomarker

7 because a biomarker wouldn't be a typical

8 endpoint in an eco-assessment, but it would

9 possibly be a surrogate. And so maybe some

10 linkage between those needs to be discussed. 

11 And then there was some discussion in the

12 charge question response that some of the

13 causal conclusions were maybe not supported by

14 exposure data. And I may have a very watered

15 down statement of that in this last sentence.

16 So anyway, I want to just go

17 through this to give you an idea of the

18 breadth of the different topics that are in

19 this summary. And I guess at this point we,

20 maybe one way to go through it is we can

21 either just go around the room and see what

22 each person thinks, or we can go paragraph by

Page 160

1 paragraph. Does anyone have another

2 suggestion or a preference? If no -- maybe we

3 can just go paragraph by paragraph then and

4 just see if there's -- or even before that,

5 having, you know, this is the first time

6 you've probably seen it, but are there any

7 sort of initial reactions about -- are there

8 things missing here, are there things that

9 don't belong here, are there things that are

10 fine, and yes. Dr. Kosnett.

11 DR. KOSNETT: That's -- you did a

12 good job overnight in capturing yesterday's

13 discussions so I think you hit on the major

14 points. I think in terms of -- I think that

15 you might want to consider strengthening the

16 recommendation for a weight of the evidence,

17 a critical you know appraisal and weight of

18 the evidence analysis for some of the causal

19 assessments that were reached in the document,

20 and that our group would like to see that

21 prior to agreeing on the causal assessments at

22 different levels of lead exposure.

Page 161

1 DR. FREY: Okay. So for the

2 second draft ISA you sort of reserve the right

3 to --

4 DR. KOSNETT: Well you know, like

5 for instance table 2-2, the summary tables at

6 different endpoints for cause at different

7 things. I'd like to see that -- well, I'd

8 like to see -- that probably should change

9 based on a critical appraisal.

10 DR. FREY: Yes.

11 DR. KOSNETT: And to the extent to

12 which. You know, I don't want to say right

13 now this is what we should say and what we

14 shouldn't say. Let them go through a critical

15 appraisal and analysis based on the weight of

16 the evidence, looking at strengths and

17 limitations, come up with a revised table and

18 we'll help with that.

19 DR. FREY: Okay. Great.

20 DR. GOODRUM: I agree with that,

21 Michael, and I think Chris, maybe the place to

22 put that in, you had a nice generic phrase at
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1 your second to last sentence "to provide

2 perspective on relevance and limitations" and

3 maybe you could add another sentence after

4 that to say for example, application of a

5 weight of evidence for some of the literature

6 and revisiting some of the tables to see if

7 you know they reflect the outcome of the

8 weight of evidence analysis appropriately. 

9 Something along those lines.

10 DR. FREY: Okay.

11 DR. KOSNETT: And I don't know if

12 you want to single out table 2-2 and table 2-

13 3.

14 DR. FREY: I think those can be in

15 the response to the charge questions. I mean,

16 EPA -- as we talked about yesterday, EPA will

17 look at the charge questions and so I think

18 the details like that could go there. I think

19 the administrator probably doesn't need to

20 know the specific table, but just this general

21 point.

22 DR. KOSNETT: Because you know,

Page 163

1 those tables, I can see them taking a life of

2 their own.

3 DR. FREY: Sure. Yes. Yes.

4 DR. KOSNETT: And people just, you

5 know, reproducing those as this is what,

6 effects of lead at these levels --

7 DR. FREY: Oh, absolutely.

8 DR. KOSNETT: -- and then. We

9 need -- that's going to have a lot more impact

10 on science and policy beyond just the air

11 thing if that stays.

12 DR. FREY: Yes, I agree with you. 

13 Yes.

14 DR. WASSERMAN: Just to clarify

15 that I think the issue with the age effects

16 was really could be better specified so that

17 they are age, like later, to adolescence,

18 young adult. I mean, they weren't ages

19 everywhere. Isn't that what you're talking

20 about, Deb? I think that's referring to the

21 point that you --

22 DR. CORY-SLECHTA: I was talking

Page 164

1 about that, but the point can be extended in

2 the sense that we've also seen the adult blood

3 lead --

4 DR. WASSERMAN: Right.

5 DR. CORY-SLECHTA: -- effect

6 levels continue to come down.

7 DR. WASSERMAN: At that level.

8 DR. CORY-SLECHTA: So I wouldn't

9 want to say gee, let's not look at them

10 because there's a lot of interest in looking

11 at lead in relation to neurodegenerative

12 disease in adults. So I wouldn't cut that

13 out, but I would --

14 DR. WASSERMAN: No, no, no, but

15 what I'm saying is that we're not focusing on

16 infancy --

17 DR. CORY-SLECHTA: -- just

18 prenatal, right.

19 DR. WASSERMAN: Right. To extend

20 perhaps the age.

21 DR. FREY: Okay. 

22 DR. WEITZMAN: As it relates to

Page 165

1 age I thought I also heard the importance to

2 stress that we no longer believe that there

3 are specific ages at which the effects end. 

4 So, or that's not just that it has effects at

5 later ages, but that earlier leads may have

6 effects at later ages or concurrent leads may

7 reflect body stores from earlier exposures. 

8 So I hope that adds something to it but I

9 think it's nuanced.

10 I also have two specific

11 suggestions. Where you have medical versus

12 behavioral? 

13 DR. FREY: Yes, right.

14 DR. WEITZMAN: I would think, I'd

15 like to hear what other people think. You

16 know, physical versus behavioral. And where

17 you have neurologic, there are any number of

18 other ways of saying that. Neurocognitive,

19 psychoeducational outcomes.

20 DR. FREY: Well, what I was trying

21 to reference with that term was how it was

22 described in the ISA. The ISA I think was
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1 using that term and the comment was not to use

2 that term.

3 DR. WEITZMAN: Right. So I'm

4 suggesting some other alternative terms that

5 you might want to use.

6 DR. FREY: All right. Okay. 

7 Other comments? I guess we could move on to -

8 - yes.

9 DR. POUNDS: Kind of a general

10 comment that probably should go in your letter

11 is -- pardon me. Is that these changes or

12 editorial or updates shouldn't be made just in

13 the context of the chapter that they're

14 referred to, that this comment is given, but

15 that the rest of the ISA document needs to be

16 reviewed and updated to be consistent with the

17 changes that are directed for some specific

18 chapter. 

19 DR. FREY: Okay. Yes, I thought

20 about that.

21 DR. POUNDS: In some instances at

22 least.

Page 167

1 DR. FREY: Yes, I thought about

2 whether it was necessary to say that, but

3 okay. Yes, it's an important point. Okay. 

4 Other comments? I guess moving on to the next

5 paragraphs. Yes, Dr. Lanno?

6 DR. LANNO: Yes, I think that in

7 that paragraph that discusses the

8 anthropogenic lead emissions inventory,

9 alluding back to our discussion about the

10 welfare effects we had at the end, that maybe

11 not just the emissions, but deposition rates

12 and where the lead is deposited. So is it

13 going to be over water, over soil, over --

14 where in the environment it actually goes. 

15 But that deposition rate is key to

16 understanding and linking the air lead to any

17 effects that we have on welfare.

18 DR. FREY: Okay. 

19 DR. RABINOWITZ: Just a very small

20 point.

21 DR. FREY: Yes, sure.

22 DR. RABINOWITZ: Do you want to

Page 168

1 say intercontinental? Transcontinental?

2 DR. FREY: What did I say?

3 DR. RABINOWITZ: Just --

4 DR. FREY: Transcontinental.

5 DR. RABINOWITZ: Intercontinental? 

6 Either way.

7 DR. FREY: I have no opinion.

8 DR. RABINOWITZ: Okay.

9 DR. FREY: I'll look it up. 

10 DR. RABINOWITZ: You want to say

11 China and not just Asia?

12 DR. FREY: Is it just China? I

13 think maybe I'll be intentionally vague on

14 that point.

15 DR. RABINOWITZ: Every chance I

16 get, you know.

17 DR. FREY: Okay. Well, maybe we

18 could scroll up then a bit to -- yes, I guess

19 to biomarkers. There's no way an engineer

20 could have summarized that correctly, so.

21 (Laughter.)

22 DR. FREY: Go ahead.

Page 169

1 DR. KOSNETT: I think one of the

2 things we said is to -- one of the things we

3 talked about was the slope of the air to blood

4 measurements. And Phil had a nice, you know,

5 critique of the various. But I think that one

6 of the things that I think there was a

7 consensus about is that the document as it

8 stands now doesn't really critically do a

9 critical appraisal of which slope do they

10 think has the greatest weight of evidence.

11 DR. FREY: Okay.

12 DR. KOSNETT: Or which should be

13 used or you know because there's quite a

14 difference between the various slopes and

15 that's a critical -- ultimately a critical

16 parameter, right? How much air relates to

17 blood. And so that section, we'd like them to

18 possibly expand on that and do a critical

19 analysis of that interpretation.

20 DR. FREY: Okay. Great. Okay,

21 well let's maybe go to the mode of action. 

22 Mode of action, health effects, susceptibility
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1 factors. Yes.

2 DR. KOSNETT: One of the things we

3 talked -- I talked about --

4 (Laughter.)

5 DR. KOSNETT: -- was possibly

6 emphasizing toxicological studies in modes of

7 action that are relevant to the low dose

8 health effects in humans, particularly those -

9 - you know, particularly where they relate to

10 disease endpoints. Or not particularly, but

11 you know, for example as they relate to

12 disease endpoints that in humans have slow,

13 you know, insidious and latent onsets like

14 cardiovascular disease. You know, in other

15 words, when we look at animal mechanisms that

16 we want to relate to human health effects we

17 want to look at mechanisms that would be

18 consistent in causing disease processes in

19 humans that we know with respect to lead are

20 not acute but you know, come on insidiously or

21 have a latent effect. And those are the

22 modes, the toxicological data modes of action

Page 171

1 which should be emphasized.

2 DR. FREY: Okay. All right. Yes.

3 DR. KORRICK: I also think Deb

4 made a good point and maybe this is too

5 detailed for this level of summary, but that -

6 - but the notion that if you give someone an

7 antioxidant and it attenuates lead effects you

8 can't necessarily imply oxidation as a

9 mechanism because you could be just altering

10 bioavailability or uptake of lead. And that

11 seems to be an error in logic that happened a

12 lot. I don't know where -- maybe that's too

13 detailed, but I think it was so fundamental.

14 DR. FREY: Yes, not that I fully

15 understand that issue, but I was thinking

16 about whether that goes here or -- it

17 definitely needs to be in the response to the

18 charge question.

19 DR. KORRICK: Well, maybe this

20 isn't the right point. I just want to make

21 sure it's clear somewhere.

22 DR. CORY-SLECHTA: Yes, it wasn't

Page 172

1 just with oxidative stress. I saw the same

2 problem with some of the other biochemical

3 studies that were cited and so care needs to

4 be taken to look at how those experimental

5 designs were set up. I just think this is at

6 least in my experience is way more detail than

7 typically would be in a letter to the

8 administrator. She doesn't really care about

9 the trees. You know, my sense -- well, okay. 

10 I guess I shouldn't say that in public because

11 that might get her in trouble, but I meant the

12 forest and the trees analogy.

13 (Laughter.)

14 DR. CORY-SLECHTA: Yes, okay. I

15 just, I think that the mode of action, people

16 in general thought that things were clear and

17 I think differences in potency or severity of

18 effects was described not so much in the mode

19 of -- well, it came up in the mode of action

20 although I think it was more trying to make

21 the -- it came up in the tables, but try to

22 make the in vitro to in vivo more -- to enable

Page 173

1 people to make those comparisons because we

2 had some problems with some of the micromolar

3 concentrations being potentially relevant or

4 irrelevant. And I think that's embedded to

5 some extent in Michael's comment. 

6 But in general I think the other

7 thing about the magnitude of effects went back

8 to susceptibility more than this because you

9 know, there's tons of studies on gene10 environment interactions which at the end of

11 the day we just never know how much they

12 really influenced anything.

13 DR. FREY: Okay. Yes. I may have

14 commingled some things.

15 DR. CORY-SLECHTA: I think some of

16 it did, yes.

17 DR. FREY: Yes, okay. That helps. 

18 Other thoughts on these paragraphs? Okay. 

19 How about the -- I think the next one is the

20 welfare effects paragraph. Okay. Any -- yes,

21 Dr. Lanno.

22 DR. LANNO: The second to last
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1 sentence there about surrogate indicators are

2 used as biomarkers. We don't really use them.

3 DR. FREY: Okay.

4 DR. LANNO: I mean, I don't know,

5 Bill, what do you think?

6 DR. STUBBLEFIELD: No, I agree

7 with you.

8 DR. LANNO: It just doesn't need

9 to be there.

10 DR. FREY: Okay. I'm happy to

11 delete it.

12 DR. STUBBLEFIELD: The only reason

13 that that point was raised I think in the

14 first place was because when they posed the

15 question of is there anything we can do to

16 reduce the size of the document. 

17 DR. LANNO: Right.

18 DR. STUBBLEFIELD: And I think the

19 question that was posed was if those

20 parameters are going to be used in this

21 process it is different from what the agency

22 has typically done in the past. And because

Page 175

1 of that it will be setting a precedent for

2 consideration of those kinds of things. And

3 if they're not going to be considered then

4 there's no reason to have it in there.

5 DR. LANNO: Yes, and those

6 biomarkers didn't have any relevance that I

7 saw, so.

8 DR. ALLEN: The only relevance I

9 saw in the biomarkers is that they're

10 conserved across bio -- across species. And

11 you may be able to gain some information that

12 may actually even be relevant to humans.

13 DR. LANNO: That's -- I think it's

14 more of an interesting academic exercise than

15 anything policy-relevant though.

16 DR. ALLEN: No, it's not policy17 relevant at this point.

18 DR. LANNO: Yes, right.

19 DR. ALLEN: But it certainly is

20 emerging science.

21 DR. STUBBLEFIELD: Well, but the

22 other point. When I went through the review

Page 176

1 document as well, one of the comments that I

2 had -- I'm sorry. One of the comments I had

3 was that as you go through this document it

4 says something about the fact that they have

5 taken into consideration all of these

6 parameters which include hematological

7 parameters, neurological parameters, et

8 cetera, but then it came back down and it said

9 and we used ambient water quality criteria and

10 we used eco-SSLs which frankly don't include

11 those parameters.

12 DR. ALLEN: They include death.

13 DR. STUBBLEFIELD: They include

14 survival, birth and reproduction.

15 (Laughter.)

16 DR. STUBBLEFIELD: Population17 relevant endpoints.

18 DR. ALLEN: Yes, that's it.

19 DR. STUBBLEFIELD: So I mean, to

20 the extent you get different offices using

21 different things I don't know if that's an

22 important policy point or not.

Page 177

1 DR. FREY: Yes, it's probably not

2 an important policy point in this context. I

3 mean, it's a good point generally, but. Any

4 other comments? Yes.

5 DR. KORRICK: This is apropos of

6 our discussion yesterday. There was a summary

7 here, there was something about clinical

8 importance.

9 DR. FREY: Yes.

10 DR. KORRICK: I can't find it. I

11 think we should --

12 DR. FREY: Yes. Could you scroll

13 I guess upward in the document? It is -- I

14 think it's -- go down another paragraph,

15 another paragraph and another paragraph. 

16 DR. KORRICK: Yes, I think we

17 should explicitly say public health as an

18 option in there.

19 DR. FREY: Okay. That's fine. 

20 That's a good point.

21 DR. KORRICK: Yes. Something

22 population-wise. There needs to be another --
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1 DR. FREY: Yes. Yes, that's good. 

2 Thank you. All right. Any last-minute

3 burning comments? Anything anyone wants to

4 say about anything that you didn't get a

5 chance to say in a day and a half? Related to

6 the ISA or the REA. Okay. 

7 Well, yes, our next step on this

8 is for you to finish your homework on your

9 individual comments for both the ISA and the

10 REA. Your contributions to the charge

11 question summaries for the ISA. If you have

12 any further thoughts about the distilled

13 points for the letter to the administrator

14 please let me know. Just remember, anytime

15 you send an email on panel business you must

16 copy Aaron and just limit the emails to a

17 small number of panel members. If there's

18 anything you ever feel like you want to send

19 to the whole panel, send it to Aaron and ask

20 him and he'll decide. But so other than those

21 ground rules we can do a lot of communication

22 kind of multilaterally through email.

Page 179

1 So once we get through the

2 preparation of the written drafts hopefully

3 this process will only take a couple of weeks. 

4 We'll send that out to everybody. Aaron will

5 schedule and give public notice for a

6 teleconference likely to take place end of

7 August, early September. So we'll have

8 another chance to review the charge questions,

9 the letter to the administrator. So there's

10 plenty of opportunity for input as we go

11 forward in the next roughly five or six weeks. 

12 Are there any sort of comments, questions

13 about the schedule or what we do next? Okay. 

14 Yes.

15 DR. RABINOWITZ: Somebody

16 suggested, I don't know if it's feasible or

17 not in any way, but when we're all done with

18 this we have this document. Is there any way

19 to attach to it the criteria document from '92

20 as an appendix or as a HERO document or some

21 way so people can have access to these earlier

22 documents?

Page 180

1 DR. VU: We can have a link in the

2 report.

3 DR. RABINOWITZ: Something like

4 that? Yes.

5 DR. VU: We can have a hyperlink.

6 DR. RABINOWITZ: And HERO could

7 have the whole thing right there, the old. 

8 Good, thank you.

9 DR. FREY: Okay.

10 DR. KOSNETT: I looked on the

11 schedule and I noticed that we're maybe due

12 for another meeting in the spring after --

13 they're going to come up with another ISA,

14 right? 

15 DR. FREY: Yes, the second draft

16 ISA.

17 DR. KOSNETT: And then we might

18 have a meeting in the spring. And I'm just,

19 I'm wondering just as a thought, the SOT

20 meeting is in the spring and it's going to be

21 in San Francisco this year. And I'm just

22 wondering if maybe you know they could back it

Page 181

1 up onto that --

2 DR. VU: Mike, wishful thinking. 

3 We're not going to San Francisco.

4 (Laughter.)

5 DR. VU: Unless the Office of

6 Research Development, toxicologists, they're

7 all going there, you know, to San Francisco,

8 but unlikely we'll have a meeting in San

9 Francisco. We'll try to make sure we schedule

10 the meeting, you know, not in the same week as

11 SOT. Okay.

12 DR. FREY: Okay. Well, I would

13 like to thank all of you for your dedicated

14 effort and the time and thought you've put

15 into this. And as I said yesterday at the

16 opening this is an important public service so

17 your work here is definitely appreciated. And

18 I think unless -- are there any further

19 comments? Okay. So I will turn the

20 microphone over to Vanessa.

21 DR. VU: Thank you, Chris. I just

22 want to express my appreciation to all of you. 
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1 You've been terrific, and Chris, chairing the

2 panel. And also I'd like to thank all the

3 agency folks who have been here a day and a

4 half, and members of the public who attend the

5 meeting and offer comments. So, and of course

6 last but not least I thank Aaron. I just want

7 you to know that Aaron always sends an action

8 item out to you so you would remember

9 everything Chris said to you about what you

10 need to do. So, it will be clear. So anyway,

11 with that I just want to say safe journey and

12 hopefully you bear the heat and embrace

13 wherever. Hopefully for those who are going

14 back to Oregon and other beautiful places that

15 maybe you could -- we'll be jealous. But

16 anyway, thank you all and I'll turn it to

17 Aaron. He has the final word.

18 MR. YEOW: And just to be clear,

19 yes, I will send out action items as well as

20 deadlines on when you need to have your

21 individual comments in for both documents as

22 well as the lead authors when you need to have

Page 183

1 your consensus responses to the charge

2 questions into us. And then I'll also follow

3 up with -- I'll schedule a teleconference so

4 I'll query you on your availability for late

5 August or early September for a teleconference

6 to go over the draft letter on the ISA. 

7 I'd like to echo my thanks to you

8 all for your participation and your time as

9 well as to Dr. Frey for leading us through

10 this on schedule and on time, earlier than --

11 earlier. I'd also like to thank EPA for their

12 participation and the public as well. With

13 that we can adjourn the meeting. Thank you

14 all again.

15 (Whereupon, the foregoing matter

16 went off the record at 11:55 a.m.)

17

18

19

20

21

22
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A

Aaron 2:13 4:15

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ability 18:13 29:9

30:13 32:9,12

34:7 40:4 63:18

73:7 103:8

able 6:2 19:8 27:21

32:14 40:9 49:21

64:7 76:22 116:19

117:20 143:12

175:11

absolute 25:13

66:19 101:10,10

absolutely 71:5

163:7

abstract 60:9

academic 175:14

accept 79:1

acceptable 141:11

141:12

accepted 147:11

access 5:9 179:21

accessible 39:5

accommodates

69:14

account 43:2

104:20 127:8

159:3

accuracy 151:2

achieve 102:5

103:5

acid 31:19

acidification 32:15

32:16

acknowledged

51:17

acronym 77:17

Act 128:18

acted 75:18

action 3:19 154:3,5

169:21,22 170:7

170:22 172:15,19

182:7,19

activity 68:21

actor 136:4

actual 31:8 45:17

102:1

acute 170:20

add 117:12 137:4

162:3

addition 29:4

additional 63:9,18

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additives 87:16

address 10:1 26:10

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addressed 44:15

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adequate 122:15

adequately 43:4

adjourn 183:13

Adjournment 3:22

adjust 54:10 55:1

55:13 124:10

adjusted 15:11

43:2 66:7 127:7

adjusting 82:20

adjustment 66:7

123:18

adjustments 51:15

106:17

administrator 6:7

6:9 144:3,19

145:4 149:15,22

162:19 172:8

178:13 179:9

admit 123:10

adolescence 163:17

adopted 32:22

adult 67:17 163:18

164:2

adults 85:10,11

101:7 164:12

adverse 64:5 141:4

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ADVISORY 1:3

advocate 68:9

affect 28:20 52:6

96:20 136:8

afraid 78:18

age 11:20 42:1 70:6

119:11,15,18

121:1 148:17

163:15,17 164:20

165:1

agency 1:1 2:11

28:12 31:14 74:22

75:18 76:5,8

110:16 174:21

182:3

agenda 4:4 8:6,14

ages 119:8 120:5,19

121:2,12 163:18

165:3,5,6

ago 9:18 11:2 66:10

120:15

agree 52:3 82:9

89:13 103:9

117:13 118:21

121:19 122:1,16

128:15 132:11

137:2,6 161:20

163:12 174:6

agreed 52:12

121:22

agreeing 160:21

ahead 4:19 71:18

74:4 168:22

air 1:3 12:6,10

13:20 14:8,17

15:8,9,12 16:7,10

16:18,21 17:4

19:6 22:4 23:5,12

30:14 32:16 38:3

47:19 53:6,22,22

54:1,1,6,7,10,12

54:22 55:5,12

56:2 58:6 59:16

62:1 68:15 70:17

75:1 76:4,5,13

77:15 78:3,13

82:15 83:8,10,10

83:12,12 84:6,14

84:17 85:12 86:5

86:11 87:9,9

89:16,21 90:8,19

91:6,7 92:2,8 94:2

100:17 101:21

102:1,10 124:3

127:3 128:18

134:2 135:4 142:6

142:8,18 143:9,13

150:16 153:16

163:10 167:16

169:3,16

airport 43:21,22

44:5 45:8 50:1

59:10,13 69:10

70:10 106:4

117:21 130:3,4

airports 44:6 47:18

49:19 50:7 59:3

60:7 99:4 115:19

129:12,16,17

air-loading 54:18

air-related 14:3,5

14:12,19 25:16

127:1

air-to 94:6

air-to-blood 93:22

Allen 1:15,16 52:14

53:7,15 86:9,10

122:7,8 125:9

128:2,5,9,12,14

129:10 131:8,9,22

140:7 175:8,16,19

176:12,18

allocating 104:3

allow 26:18 29:2

34:16 39:16,21

60:11 63:11 99:8

100:1 101:17

114:3 120:21

allowed 12:18 18:4

93:19

allows 58:20

111:12

alluded 140:22

alluding 167:9

alphabetical 71:20

131:7 132:4

altering 171:9

alternate 15:15

22:5 124:15

alternative 63:5

108:2,9,15 166:4

altitude 99:2

ambient 12:6,10

13:6 14:8,16

15:12 16:7,10,17

16:20,21 17:4

22:22 23:5,5 30:3

30:19 53:6 54:12

57:20 58:5 70:16

89:21 92:2,8,13

124:10 150:2

152:16 176:9

America 138:5,10

amount 43:8 85:11

113:22

amounts 42:20

133:9

analogy 88:16

172:12

analyses 29:20

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109:13

analysis 9:11,20

11:4,5,14,21 12:1

13:9 14:20 18:10

18:19 19:11,17

20:7,11 26:8

27:15 28:4 31:3

42:4,10,14 46:9

48:1 61:12 66:4

71:11 94:8 110:5

116:12 158:20

160:18 161:15

162:8 169:19

anchor 11:11

anchored 38:17

and/or 9:12

anecdotal 134:4

Angeles 13:6
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answer 67:21

answers 4:14 5:5

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anthropogenic

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anticipated 150:20

antioxidant 171:7

anymore 140:9

anytime 7:12

178:14

anyway 27:15 92:4

134:14 136:18

138:22 159:16

182:10,16

appear 80:19

138:13

appendix 179:20

applicable 39:19

77:18

application 137:17

158:8 162:4

applied 15:11

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apply 34:8 69:13

71:15 89:1 137:21

apportion 30:13

32:9 40:5 143:4

apportioning 25:15

142:11

apportionment

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64:20 66:12

apportionments

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appraisal 160:17

161:9,15 169:9

appreciate 60:13

140:17

appreciated 181:17

appreciation

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approach 10:8

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34:19 43:12 60:21

60:22 61:3,3,6

71:6 102:8,14,17

119:2 120:4

128:19 137:8,22

138:15 139:9

141:16

appropriate 34:21

37:14 77:19 80:21

121:17 145:22

appropriately

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apropos 177:5

aquatic 137:11

140:2 157:15

ARAR 77:20

ARARs 77:17

arbitrary 72:17

area 12:13 21:4

28:18 29:4,7

45:14 46:1,22

47:14 48:3,9 49:4

92:1 132:22 134:3

areas 12:22 16:22

21:15,17 22:3

23:22 28:17 31:5

31:6 34:14 44:7

45:3,16 47:13

49:4 50:4 61:14

72:20 133:22

154:6

Arguably 46:11

argue 39:18 110:6

argument 47:16

arrows 79:18,18

article 59:5

ashamed 81:18

Asia 151:21 168:11

asked 4:15 123:11

aspect 18:20 19:11

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aspects 10:17 20:7

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105:21 106:11

assess 9:7 13:13

64:7 119:21 140:4

assessed 12:17 29:7

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assessing 11:19

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assessment 3:13,15

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10:3,4,20,22 11:6

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17:22 18:20 27:5

28:11,16 29:8,11

30:8 31:10 34:17

36:4,6,6,7,11

37:19 40:20 42:4

42:6,8,12 43:1,14

43:15 44:12,17,21

50:18 52:9,10

53:4 55:9 60:16

63:3,6,11,17

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67:22 68:8 69:22

71:19 76:10,11

78:16 80:20 82:12

90:2 92:17 93:10

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101:1,5 102:7,11

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107:2,11,19 108:4

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110:18,19 111:13

111:18,22 112:4,5

112:7 113:4,21

114:2,21 115:7

117:4,6,9,10

119:1,2 120:4

122:3,22 123:13

124:2,13 125:11

131:4 132:18

135:2,21 136:17

136:18 137:10

138:21,22 141:2

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assessments 29:16

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65:19 160:19,21

assessor 64:14

assigned 145:19

associated 31:19

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60:21 61:22 64:5

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assume 20:15

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assumed 20:19

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assuming 48:4,6

assumption 52:21

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assumptions 90:7

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asterisk 60:6

astute 125:19

atmosphere 85:6

atmospheric 142:3

attach 179:19

attainment 22:7

attempt 145:14

attempted 13:1

15:8 144:12

attempts 150:11

attend 182:4

attention 79:2

attenuates 171:7

attribute 68:1

attributes 33:21,22

attributing 154:18

August 5:22 112:7

112:14,15 118:8

146:5 179:7 183:5

August/early 7:20

author 148:4

authors 182:22

automobile 88:7

availability 138:19

183:4

available 28:5 32:7

34:16 38:9 41:13

71:3 105:1 130:12

135:2 138:21

140:3 141:6

average 17:14

83:18,18 84:11

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avgas 43:20 44:12

48:11 99:21

109:13 115:4

129:2

aviation 43:20 44:6

99:1,4,9,19

115:15,19 117:15

129:1,12

avoided 128:22

aware 101:1 125:20

130:11

awhile 146:7

a.m 1:13 4:2 131:1

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B

back 6:12 9:16 22:6

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56:22 60:3 72:1

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88:12 89:3 104:10

106:11 111:20

112:11 113:2

144:9 146:15

149:14 167:9

173:7 176:8

180:22 182:14

background 43:1,3

50:12 51:8,9,13

68:14,14 74:12

151:6,15,19

bad 88:16 129:7

baghouses 127:13

balance 149:9

150:22

balancing 38:8

Barre 133:19

base 11:10 35:6

114:20

based 6:10 9:8

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30:8,18,21 37:5

38:22 41:5 43:11

45:1 61:12 63:19

95:6,8,10 101:5

101:15 114:4

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basic 82:11

basically 61:19

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basis 17:11 36:11

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batting 122:9

BCD 1:11

beans 88:21

bear 83:14 182:12

beautiful 182:14

beginning 145:18

begs 109:6

behavior 48:7

behavioral 155:12

165:12,16

believe 9:22 27:2

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believed 12:15

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belong 145:7,8

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belongs 79:17

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benchmark 61:14

benefit 119:20

best 107:17

bet 57:5,10

better 26:22 39:9

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133:5,9 163:16

beyond 8:1 42:2

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bias 125:11

biases 39:17 41:9

big 60:6 85:3 89:9

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Bill 174:5

bio 175:10

bioavailability 33:7

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biochemical 172:2

biokinetic 70:5,12

biokinetics 68:6

biomarker 159:6,7

biomarkers 153:9

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biometric 13:14

bio-accumulation

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bio-concentration

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birth 176:14

bit 8:22 51:12

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blinders 100:18

blood 13:11 17:8

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65:1 79:15,16

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body 165:7

Bone 79:16

bottom 82:16

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bound 83:5

bounding 85:14

bounds 125:10

box 79:7 91:1

boxes 74:2,21

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breadth 159:18

break 8:13,14,15

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breathing 87:1

brief 10:22 20:10

122:13

briefly 20:12 28:8

bring 38:5 40:15

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121:4 150:6

bringing 41:14

broader 13:2 21:8

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broadly 12:4 29:12

47:5

brought 41:4 77:13

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Bryan 2:16 8:17

10:15,18 27:18

110:14 120:8

budget 118:15

119:6

build 103:1

building 28:11

builds 32:5

bullet 24:12 25:8

52:15

bullets 52:16

bunch 124:17

143:5

bundled 55:19

burdens 154:21

burning 178:3

business 114:19

178:15

C

calculated 30:22

call 7:1 53:21

112:14

called 35:19 52:19

77:17 113:13

142:12

Canada 100:22

Canadian 128:16

Canfield 122:6

cans 86:14,16

88:22

capital 133:17,18

captured 85:13

110:8

capturing 160:12

carbon 87:3

cardiovascular

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care 154:18 172:3,8

careful 125:19

Carolina 1:12 59:8

117:18

carried 45:14

CASAC 1:14 8:3

11:3 26:13 75:14

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112:2,10 149:15

149:18 150:1

case 11:22 12:2,3,5

12:7,9,13,18

16:18 28:17 32:20

45:12 60:1,13

61:13 73:8 91:19

109:14 117:15

118:3 119:3 122:3

126:12,17 127:5

142:2 158:13

cases 148:6

categories 12:4

category 12:5,22

14:4 55:7

caught 119:8 151:7

causal 62:16

147:10 159:13

160:18,21

causality 73:2,6

cause 136:3 141:4

161:6

causing 38:3

170:18

cc 7:12

CDC 96:9

center 126:1

central 79:17

certain 22:19 37:17

70:22 95:7

certainly 37:2

48:19 51:11 58:16

60:6 63:15 65:21

70:17 71:22

104:19 114:11

122:15 125:6

127:21 129:14

136:1 140:17

175:19

cetera 141:22

143:4 176:8

chain 88:1

Chair 1:13,15

chairing 182:1

challenge 18:18

40:5 98:7

challenges 21:13

Champlain 133:15

chance 7:8,21 57:5

144:13 168:15

178:5 179:8

change 16:9,10

22:21,22 23:4,6

23:11,12 31:9

34:9,18 43:13,14

52:17,22 53:2,12

55:5,10 56:1,1

58:14,15,21 61:2

61:15,18 62:5,6

83:8,9,13,14,20

83:21 86:12 89:9

125:3,8 161:8

changed 41:8 53:1

55:12 62:3 63:1

63:21 65:2 86:13

86:16 125:4

changes 15:20

29:10 53:5 54:18

56:13 59:21 65:11

69:5 85:15 86:13

87:8 122:20,20

166:11,17

changing 15:13

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characterization

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characterizations

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characterize 9:12

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characterized 21:5

41:21 50:16

characterizing

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24:9,17 26:5,22

51:13 71:9

charge 4:11,22 5:3

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145:21 146:3,10

146:21 147:13

151:7,9,10 152:4

152:12,20 153:17

156:15 158:9

159:12 162:15,17

171:18 178:10

179:8 183:1

charged 144:4

chart 73:21 90:16

charts 90:10

check 20:4 58:17

131:18

Chicago 13:5 17:1

child 18:18,22 19:5

19:10 21:3 86:19

children 11:19 12:5

12:16,20 13:3

18:2,3,3 19:3

20:21 21:6,9

24:14,21 25:11

46:10,20 47:6

59:13 65:1 68:17

69:3,8 76:12

92:11 101:6

119:16

children's 127:1

child's 39:6

China 168:11,12

choosing 147:1

chose 96:6

Chris 1:19 52:14

122:8 139:17

161:21 181:21

182:1,9

Christopher 1:13

1:15

cited 172:3

cites 148:3

cities 13:5 21:18

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city 133:18

clarification 35:10

36:14 50:10 60:18

82:3 89:16 121:7

clarified 158:3

clarifies 125:15

clarify 36:2 40:20

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91:8 97:18 98:11

109:11 110:12

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clarifying 90:19

clarity 113:3

classification

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Clean 1:3 128:17

cleaning 24:6 38:16

39:1,3,10

cleanup 56:20 57:3

122:9

cleanups 75:11

clear 9:1 42:15

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153:11 171:21

172:16 182:10,18

clearer 98:22 99:7

clearly 14:12 16:6

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135:12 148:8

Cleveland 13:5

17:1

Cliff 1:17 137:3

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clinical 155:2 177:7

close 12:11 59:13

92:12 110:20,20

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closed 56:4 57:12

closer 92:7

closest 130:7

coarse 126:14

cognizant 74:15

coherent 81:13

82:6

cold 8:22 142:22

colleagues 56:11

140:14

collect 76:2,9

collected 48:22

75:1 76:17

collection 139:7

College 142:14

column 133:8

combination 14:22

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combinations

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combine 149:4

combustion 48:11

126:13,22

come 6:12 9:2 51:1

72:1 85:3 86:18

98:14 101:18

103:16 104:10

113:2 121:15

140:20 144:9

146:15 150:12

151:8 156:2

161:17 164:6

170:20 180:13

comes 25:16 38:14

43:20 77:2 135:19

136:1 140:6

comfort 146:17

comfortable

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coming 44:11 48:5

51:9 85:5 116:1

134:21

comment 105:20

108:17 119:5

122:10 123:1

128:16 135:5

136:19 147:3

166:1,10,14 173:5

commented 120:6

comments 4:20

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67:20 74:17 80:17

80:22 82:2,4,18

89:15 100:3

105:14 109:16

121:20 128:15

130:16 131:10,19

132:11 135:13

143:17 144:1

147:12 149:20

154:4 157:16

166:7 167:4 176:1

176:2 177:4 178:3

178:9 179:12

181:19 182:5,21

commingled

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committee 1:3 75:6

112:2 149:8

committees 100:9

common 21:11,21

communication

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community 69:8

159:4

comparable 94:15

compare 141:2

150:11 153:22

compared 61:14

94:6

comparison 154:13

comparisons

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compartment

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compartmental

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compartmentaliz...

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compartments

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compiled 4:14

complete 64:21

completed 9:17

11:1,18 31:13

completely 81:17

84:15 137:2

complex 67:1

compliance 78:3,7

complicated 11:6

15:5 16:14 46:6,9

92:4 127:12

complying 77:21

component 15:2

65:4

comprehensive

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concentration

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24:4 25:22 26:1

31:1 47:20 48:20

49:2 61:21 68:13

68:22 92:9 142:3

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concentrations

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61:12 63:1 64:6

68:18 74:12,15

116:4,6 124:12

127:3 134:13

141:3,3,11,21

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173:3

concept 28:10,11

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35:1,2 67:15

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concepts 32:5

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conceptual 32:18

conceptually 124:9

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concerted 120:15

conclude 116:16

concluding 64:4

conclusion 27:2

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conclusions 61:8

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conclusive 58:2

concur 82:10

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concurrent 17:14

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conditions 124:22

conduct 18:1 34:12

conducted 20:7

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conducting 27:4

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conference 146:7

confidence 21:22

confident 26:17

confound 150:10

Confounders

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confused 123:10

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confusion 98:6

congratulations

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connecting 79:19

consensus 109:20

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consider 8:2 13:16

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consideration

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considered 7:16

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considering 9:20

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consistency 147:16

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consistent 74:10

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consistently 155:14

constantly 87:4

constitute 43:10

consultation 4:4

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consulting 56:10

contact 51:19

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containers 86:16

contaminant

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contamination

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content 134:12

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context 25:18

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continues 40:5

continuing 100:1

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contractors 104:4

contributed 87:10

contribution 15:2

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contributions

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controllable 51:5

123:14,15 124:5

125:17

controlled 44:9

conundrum 78:15

convened 1:11

conventional

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conversions 24:5

convert 25:14

conveyed 144:2

convoluted 80:5

convolution 80:6

copy 178:16

core 155:22

corollary 107:16

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177 3:19

183 3:22

1970s 84:11,18

1975 88:4

1980 84:2

1982 75:6

1986 75:9

1990s 75:19

1991 75:13,15

2

2 72:22 149:1,10

162:12

2mcg 84:19

2-15 83:5

2-2 123:14 161:5

162:12

2-5 79:5

2-6 126:8

2-8 126:8

2-9 73:20

2.1 79:5,10 80:2,6

90:22

2.1.1 123:13

2.1.2 79:21

2.1.4 123:21,22

2.2 73:20 91:5,5

2.5 101:12

20 75:2 129:17

2005 19:16

2006 157:11

2008 149:20

2011 1:9

2012 112:6,7

2013 114:22

21 1:9

212 72:7

215 124:1

25 86:6 101:17,20

101:21,21

29th 5:13

3

3 122:12,15 151:11

162:13

3.2 141:17

4

4 3:9 151:11

4700 1:12

49 43:19 44:11

99:12

5

5 26:3 52:15

5th 5:22

5-year 75:6

50 127:17 129:22

500 59:9

550-foot 126:15

128:7

6

6 156:16

60 127:17

7

7.5 20:2 96:14,15
202-234-4433

Neal R. Gross & Co., Inc.

Page 209

97:3

71 3:15

8

8:30 1:13 4:2

9

9 3:13

90 84:1

92 179:19

95th 19:3 65:7