### 202-234-4433 Neal R. Gross & Co., Inc. Page 1 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 2

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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 4 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 5 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 6 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 7 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 8 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 9 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 10 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 11 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 12 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 13 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. So20 in other words you can't just look at the air21 related exposures, you have to consider full 22 exposures.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 14 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 15 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 do8 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 16 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 17 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 18 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 19 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 20 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,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 21 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 22 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 23 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 24 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 25 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 26 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 27 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 28 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 291 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 the10 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 30 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 lead7 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 31 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 32 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 33 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.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 34 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 that20 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?

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 38 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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. Once4 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 42 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 background and a risk assessment has to be2 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 46 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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're6 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,

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 50 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 lead18 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 54 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 571 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.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 58 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 those11 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 62 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 risk17 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 66 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,

### 202-234-4433 Neal R. Gross & Co., Inc. 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. The21 answer to how we use NHANES data and larger22 scale data to inform the risk assessment is

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 70 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 74 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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,

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 78 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 82 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 between6 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 86 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 90 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 931 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 94 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 those6 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?

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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?

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 98 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 102 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 106 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 110 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 the16 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 114 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,

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 118 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 122 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 126 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 130 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 134 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 roadways7 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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?

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 138 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 142 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 146 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 150 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 154 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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,

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 158 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 162 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,

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 166 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 170 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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 you9 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

### 202-234-4433 Neal R. Gross & Co., Inc. Page 174 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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 --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 178 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.

### 202-234-4433 Neal R. Gross & Co., Inc. 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?

### 202-234-4433 Neal R. Gross & Co., Inc. 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 182 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

### 202-234-4433 Neal R. Gross & Co., Inc. 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.)

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### 202-234-4433 Neal R. Gross & Co., Inc. Page 185 animal 156:8 170:15 answer 67:21 answers4:14 5:5

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### 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 65:7NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com C E R T I F I C A T E

This is to certify that the foregoing transcript

In the matter of:

Before:

Date:

Place:

was duly recorded and accurately transcribed under my direction; further, that said transcript is a true and accurate record of the proceedings.

----------------------- Court Reporter 210

Clean Air Scientific Advisory Committee Lead Review Panel

EPA

07-21-11

Durham, NC