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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 CLEAN AIR SCIENTIFIC ADVISORY

 COMMITTEE (CASAC) LEAD REVIEW PANEL

 PUBLIC MEETING

 HILTON GARDEN INN RALEIGH-CARY

 CARY, NORTH CAROLINA 27518

 FEBRUARY 6, 2013

Court Reporter:

Wanda L. Greenlee, CCR

Missouri CCR #1188

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711 North Eleventh Street

St. Louis, Missouri 63101

(314) 644-2191
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1 (WHEREIN, meeting convenes at 8:37 a.m.)

2 DR. FREY: All right. Good morning. We're

3 going to go ahead and end our recess from last night, and

4 this morning's agenda includes a few main things, some of

5 them on the agenda and some that I'd like to circle back

6 to.

7 We will have -- if there's any need for

8 more discussion on Chapter 4, we can include that. Our

9 main items as far as the policy assessment are to discuss

10 Chapters 5 and 6. We have an opportunity at the end of

11 the morning for clarifying comments from the public, and

12 if anyone from the public would like to make clarifying

13 comments, they should contact the designated federal

14 officer, Aaron Yeow, to get on the list.

15 We have a summary and wrap-up at the end of

16 the morning, and then we're planning to adjourn no later

17 than 12:30. In addition to discussing the charge

18 questions, I'm anticipating we'll get through that

19 probably before the morning's over. But I would like to

20 make use of our face-to-face time to circle back on the

21 consensus response to charge questions on both the ISA and

22 the PA.

23 Just -- I know some of the lead discussants

24 have prepared draft text on that, that at least has been

25 copied to both me and Aaron, and perhaps others have been
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1 doing that that haven't shared it yet. But while we're

2 face-to-face is our best opportunity to have discussion

3 and clarification and deal with any complex issues. So

4 I'd like to take a few minutes to do that.

5 And also related to that is also to

6 identify research needs, whether it's reaffirming what's

7 in the policy assessment in Chapters 4 and 6 as research

8 needs or adding to that because that is something at this

9 stage in the review process CASAC typically will want to

10 advise the administrator on research needs to move things

11 forward in anticipation of the next review cycle.

12 Any questions about the agenda?

13 (No response.)

14 DR. FREY: Okay. Let me ask Deborah and

15 Sean and Susan, are there any additional issues on Chapter

16 4 that you would like to discuss with the panel? And for

17 any members of the panel, are there any additional issues

18 on Chapter 4 to discuss right now?

19 (No response.)

20 DR. FREY: Okay. Well, if not, I would

21 like to then go to Chapter 5. And Chris Johnson is the

22 lead discussant, and Herb Allen and Roman Lanno are

23 discussants. So I will yield the floor to Dr. Johnson.

24 DR. JOHNSON: Thanks, Chris. Good morning,

25 everybody. So those of you who are in academia know the
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1 most annoying professor is the one who agrees with the

2 conclusion but objects to the process. So I try not to be

3 that person, but I think I'm going to be that person this

4 morning.

5 So we have three charge questions for

6 Chapter 5. The first is to what extent the information in

7 the first section of Chapter 5 captures and appropriately

8 characterizes the key aspects of the evidence assessed and

9 integrated in the ISA.

10 I think my colleagues will agree with me

11 that the -- this chapter, this section of the chapter,

12 does a very nice job of synthesizing a very large amount

13 of information in the ISA in making it, you know,

14 understandable. It reads well and, you know, leads to the

15 conclusion that they make in that.

16 I had a couple -- you know, I have a couple

17 general issues and maybe I just need to be educated a

18 little bit. But two of the things that have come up a

19 number of times in the discussion of the ecological

20 effects are that it's difficult to isolate the effects of

21 air lead, current modern air lead, from other sources,

22 including so-called legacy lead that's accumulated from

23 past years in soils and sediments and also that it's

24 difficult to isolate the effect of lead from other metals

25 and stressors.
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1 So you know, I think that to me, you know,

2 especially the issue of legacy lead from an ecological

3 perspective, it seems like it -- you know, it doesn't

4 matter to the organism whether that's new lead or legacy

5 lead if low levels of air lead now essentially make that

6 legacy lead more problematic than it seems you can

7 consider a standard for current air lead that accounts for

8 that.

9 So this comes up in the next part as well.

10 So the secondary -- so a secondary standard might be lower

11 than it would be otherwise because of the presence of this

12 legacy lead.

13 The second charge question asks whether --

14 with regard to the exposure and risk information in the

15 second section whether the -- to what extent is the

16 information drawn from the screening level risk assessment

17 in the last review sufficiently characterized and

18 communicated, to what extent is it appropriately

19 interpreted in the light of the currently available

20 information.

21 So the decision was made not to do another

22 REA, and after reading this section and sort of

23 understanding it better, I was not part of the process

24 last time. I meant most of, I think, weren't. But it

25 left me scratching my head about whether that REA four
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1 years ago, five years ago was deemed to be appropriate.

2 And again, I might just need to be educated a little bit

3 in terms of this.

4 So the interpretation of the results is

5 appropriate in that it restates the conclusions from that

6 document, and it is -- it does appear that there's not a

7 lot of literature in the last five years to change any of

8 the basic assumptions.

9 The -- after reading, though, the -- this

10 section of the PA, I really wonder whether the REA that

11 was done, at least for the ecological effects, last time

12 was effective for the purpose for which it was done.

13 There were four case studies -- if I

14 understand correctly, there were four case studies that

15 were applied. One was a primary smelter situation, which

16 I assume was bottled after the Herculaneum site. One was

17 a roadside -- two roadside sites, one maybe in Corpus

18 Christi and one in Virginia or Maryland. One was Hubbard

19 Brook and then the Naqua -- you know, the -- not Naqua,

20 but the water -- the aquatic site.

21 Sorry, no. There was a -- I'm sorry, there

22 was a secondary smelter case. Yeah, for the terrestrial

23 effects, there were four. There were -- there was the

24 primary smelter, secondary smelter, roadside and Hubbard

25 Brook. So in looking at those four case studies, the
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1 results from two of them, the primary and secondary

2 smelter cases, were judged to be not informative. And if

3 I understand the logic there for the primary smelter site,

4 the conclusion was that the air concentrations and the

5 concentrations of various media were above -- or the air

6 concentrations were above the standard that was set. So

7 you can't really learn whether the current level --

8 current standard is causing a negative effect.

9 The same for the secondary -- the relevance

10 of the third case study, which was the roadside study, was

11 deemed highly uncertain because of the presence of legacy

12 lead in those roadside soils. So the only case study of

13 the four that was deemed relevant was the Hubbard Brook

14 case, and the ambient air concentrations in Hubbard Brook,

15 although not measured are almost certainly very low, much

16 lower than the current standard.

17 So it's seems to me that at least on the

18 terrestrial side, it seems to me that the -- did the REA

19 really address anything that was relevant to this

20 particular question of what the effects would be at this

21 proposed standard.

22 So if I understand this correctly, the

23 ideal case to -- the ideal case you would look at would be

24 a case where the ambient air concentrations are a little

25 bit below the standard -- the standard value and a place
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1 where you had sufficient data that you could characterize

2 key populations and media in order to effectively

3 calibrate the model. Is that more or less correct?

4 MS. TENNANT: Well, a couple things, the

5 original REA was done as a sort of pilot level screening

6 assessment using a hazard quotient to basically say there

7 was the potential or there wasn't the potential for

8 effect. So that's the framework that the original REA was

9 done in. And ideally for this time, of course, we would

10 have some type of critical loads information where we

11 could actually take into account legacy lead and determine

12 what the effects of the existing lead were and then how

13 much more lead could be introduced into the system and

14 controlled for some effect, but we just don't have that

15 information.

16 DR. JOHNSON: But these four -- okay. I

17 get that, but these four cases -- I mean, with, like I

18 say, three of them basically being either non-informative

19 or highly uncertain and one being for a site that has --

20 probably has air lead concentrations that are so far below

21 the standard that, you know, you're not going to see

22 effects anyway. I'm having a hard time envisioning the

23 EPA ever having data from a site that could inform this

24 process. And if that's the case, then why do the charade?

25 MS. MURPHY: Well, I think there's a lot of
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1 interest in the critical loads process and whether or not

2 the information available for lead will ever be sufficient

3 to inform a critical loads analysis. Because, as you

4 point out, it has -- there's this temporal aspect that

5 really you need to consider and the dynamics of lead in

6 the environment.

7 One thing we face with other criteria

8 pollutants, of course, is we don't have this multimedia

9 and persistent characteristics that we have to deal with.

10 And so in those cases we are looking for locations and

11 information where we are at and above and below the

12 standard to look at those response analyses, et cetera.

13 But the data set for lead is not as easily used for such

14 things.

15 DR. JOHNSON: Okay. So if a group is here

16 in five or six years, I mean, is it going to be possible

17 to do this any better than it's already done?

18 (WHEREIN, unintelligible due to multiple

19 people speaking at once.)

20 DR. JOHNSON: I mean, if not, why -- I

21 mean, if not, why even do it? I mean --

22 MS. TENNANT: Well, I would hope that

23 sometime in the future we would develop the ability to

24 look at critical loads for lead because that really seems

25 to be the most promising path forward, similar to the way
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1 that we look at deposition for NOx and SOx and aquatic

2 acidification. It's the -- it's just that the data set

3 for lead just isn't there. It's not at the same level in

4 development as that.

5 DR. JOHNSON: Okay. So if you were charged

6 to -- I mean, if you were charged to do another REA, at

7 least for the ecological side of things, I mean, would --

8 what could you -- I mean, would you -- I don't know. I

9 don't want to revisit the whole thing that we talked about

10 at our last meeting, but the -- the data needs -- the

11 sites that were selected were selected because they --

12 largely because they were sites that have data. Is that

13 fair to say?

14 MS. TENNANT: Well, and they're sites that

15 had a pretty good set of data for what it was, and they're

16 sites that show different types of exposure lead and

17 sources --

18 DR. JOHNSON: Uh-huh.

19 MS. TENNANT: -- and then more of a

20 nonpoint source or ambient.

21 DR. JOHNSON: Uh-huh. So with the

22 declining amount of research that's going on in lead, like

23 I say, it's hard to envision that this situation is going

24 to get better, but it might. I mean, I don't know.

25 DR. MURPHY: I'll just offer one comment
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1 recalling some of the discussions from the previous panel

2 who also struggled with this, and I remember -- I can't

3 remember what panel member it was. He talked about the

4 importance of monitoring trends in the environment at

5 critical sites to see if you at least had trends going in

6 the right direction, you know, with different sorts of

7 indicators because of the limitations in the available

8 database that we have.

9 DR. JOHNSON: Uh-huh.

10 DR. MURPHY: But the previous panel as well

11 struggled with the issue.

12 DR. JOHNSON: Uh-huh. And I guess the

13 reason I spend at least a few minutes talking about it

14 here today is that, you know, with the way that this

15 process is set up is that, you know, there's been a

16 judgment and now the next -- like just in this case, our

17 focus has been what do we know from the last five years

18 that -- you know, that's changed our understanding.

19 So the previous judgment sort of becomes

20 the default, and if you can't -- if you don't know any

21 more that's going to change, then you just -- then that

22 continues to be the interpretation or the understanding.

23 So you know, it's now -- it's now -- we

24 have an REA from the last process, and that's in place.

25 And now the decision has been made, more or less, that
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1 there's not enough to justify redoing it. There's not

2 enough that indicates that we have a better understanding

3 of these processes. And you know, it's -- I just -- I

4 have some concerns that in five years it's going to be the

5 same, and then the same, and the same. So we've

6 institutionalized a process that at least I don't see as

7 being -- having been effective from the beginning.

8 DR. MURPHY: I'll just make one more

9 comment. I think some of the things you're mentioning go

10 toward the research needs discussion that you-all have

11 alluded to having. The other thing I'll mention is that

12 the decision that we faced in the last review was

13 different than the decision that we face this review.

14 I mean, we always say, you know, what does

15 the currently available evidence and risk information tell

16 us? Does it call into question or support the current

17 standard? Well, in the last review, we had a standard ten

18 times as high, and our conclusion with regard to the

19 secondary was that the evidence, while uncertain and

20 limited for a number of purposes, did seem to call into

21 question the adequacy of that standard.

22 It didn't give us what we needed to set us

23 a distinct secondary standard, but it did do one step

24 there. In this review, now that we're looking at a much

25 lower standard, we find it hard to make the first case.
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1 So it is a different decision that we face under the same

2 overarching question each time.

3 DR. JOHNSON: Yes. Okay. Well, and then

4 in regard to the third -- the third question was basically

5 on the limitations and uncertainties of characterized and

6 considered. And I think certainly the document is

7 forthcoming about, you know, many of the things we've just

8 talked about, but the uncertainties and missing data that

9 there are in the database. So those are my comments, my

10 concerns. And you know, I yield the floor to my

11 colleagues.

12 DR. FREY: Okay. Thank you, Dr. Johnson.

13 Dr. Allen?

14 DR. ALLEN: I really didn't find any real

15 significant problems with this section. I basically like

16 it. There are a couple of technical issues in it, and

17 they're in my write-up. And I think that's it.

18 DR. FREY: Okay. Thank you. Dr. Lanno?

19 DR. LANNO: Yeah, I don't know if I have

20 too much more to add to it than Herb, and I think that

21 Chris sufficiently flogged the process horse, and that's

22 the last we'll discuss of that. But I think that the

23 discussion of the uncertainties was good, and I

24 appreciated the fact that you also discussed the

25 uncertainties of the screening levels that were used to
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1 make the hazard quotient assessments because we always

2 talk about our data limitations and stuff, but we forget

3 about the actual denominator in the quotients.

4 And that was important to point out

5 especially for Eco-SSLs where they're ultraconservative to

6 begin with, and so that really tends to indicate that

7 maybe we have more of a hazard than we really do.

8 Other than that, I don't think I have too

9 much more to add to that. I think the section was

10 well-written. And given its function, what it's supposed

11 to perform, I think it adequately does that and addresses

12 the issues.

13 DR. FREY: Okay. Great. Other panel

14 members? Dr. Kosnett?

15 DR. KOSNETT: I was pleased that the second

16 draft of the ISA and continuing onto the third draft of

17 the ISA included in the discussion of the ecological

18 effects of lead the implications of lead ammunition that

19 have been of increasing concern of their effect on

20 raptors, for example, the California condor, and the bald

21 eagle, and other things.

22 And in the past few years, there has been

23 petitions to EPA or increasing concerns about the

24 ecological effects of lead-related ammunition. And I'm

25 glad you mentioned it in the ISA. But what I notice is
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1 that in this particular PA, when you talk about sources

2 and emissions and the impact on the ecological -- you

3 know, the ecosystems, I don't believe that ammunition

4 shows up as mentioned at all.

5 And there is even a chart on -- you know,

6 on Table 2.2 -- well, no, 2.2 is not the right one.

7 There's another chart on total number of emissions, 2.1,

8 by source categories. And I guess this is based in part

9 on, you know, the toxic release inventory, the TRI. And

10 you -- there is no way to assess, you know, what the

11 implication has been.

12 But there are some studies on that, and

13 there is some literature on that. And especially since

14 we're talking about critical loads and our need to

15 increase understanding about critical loads and how the

16 incremental effect of air will impact the critical load of

17 lead, I think that the ecological discussion in the policy

18 statement would benefit by a short but succinct discussion

19 of the fact that this is another stressor on certain

20 aspects of the biota, particularly the large birds.

21 And that should be taken into consideration

22 on policy decisions about incremental effects of air

23 pollution to understand that as a base component because

24 they're one of the -- and maybe Roman, you would know it

25 or agree, but the large birds are some of the few species
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1 that are actually dying of lead poisoning, right?

2 DR. LANNO: Yeah. I don't disagree with

3 that. I think that in the document they actually exclude

4 lead shot from -- I mean, although it's accelerated

5 atmospheric deposition as such --

6 DR. KOSNETT: Yeah.

7 DR. LANNO: It's not -- well, and in terms

8 of critical loads, it's not what we're really thinking

9 about -- and I agree that it's a big -- it is an issue.

10 You know, obviously, it's been addressed by -- for water,

11 for the hunters changing from lead shot to steel shot and

12 tungsten shot, which probably has its own issues, but it's

13 been addressed. For the raptors, it's a different story

14 because, I guess, in terrestrial systems you can still use

15 lead shot so --

16 DR. KOSNETT: Yeah.

17 DR. LANNO: -- it'll wind up in carcasses

18 of animals that -- but I don't know.

19 DR. KOSNETT: There was a meeting that I

20 attended a few years ago by the Peregrine Fund, and they

21 produced a proceedings, a published book, about the

22 implications of lead ammunition on ecological receptors

23 and to a limited extent on people who harvest -- eat game

24 meat harvested with ammunition.

25 But there was a lot of information there
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1 that, frankly, opened my eyes because I hadn't -- I hadn't

2 realized that. So I just would encourage some reference

3 to that literature. I don't think you would have to do a

4 ton of research. I think most of it's actually -- if you

5 go to the Peregrine Fund site, a lot of the -- that

6 literature is pulled together by their team, and it might

7 be mentioned because they are the bird -- they are the

8 single receptor that is dying -- well, I don't know if

9 it's a single receptor, but that's clearly a receptor that

10 is dying from lead poisoning. Okay. That's my --

11 DR. MURPHY: If I could just mention along

12 the lines of what Dr. Lanno said, we certainly could

13 identify that as another source of lead to the

14 environment. It's not one likely to be affected by a

15 national ambient air quality standard.

16 DR. KOSNETT: Right. But consideration,

17 you know, of any incremental standards should understand

18 other sources, and you do that. You know, you identify --

19 you mention lead paint, and you mention other things in

20 these documents, so you mention that. And Chris, you said

21 earlier that we have the ability to be a little bit broad

22 in our understanding.

23 And since these documents are so valuable

24 above and beyond their utility just in the air standard

25 but as a resource to the rest of the agency for all of its
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1 considering impacts, I think mentioning it is -- would --

2 is helpful.

3 DR. FREY: Okay. Good. Yeah, I suppose if

4 we wanted to make headlines, we could say we were

5 considering airborne ammunition as a form of air

6 pollution, but I'm not recommending we do that.

7 UNIDENTIFIED SPEAKER: I think the sampling

8 is rather difficult --

9 DR. KOSNETT: High-volume sampling, right.

10 DR. FREY: Right.

11 UNIDENTIFIED SPEAKER: We might have the

12 NRA visiting us.

13 DR. FREY: But -- okay. Other comments on

14 Chapter 5?

15 (No response.)

16 DR. FREY: Okay. Well, then let's move on

17 to Chapter 6. This is review of the secondary standard.

18 So this is, you know, kind of the bottom line here as far

19 as the advice to the Agency on whether to retain their

20 current standard.

21 So the lead discussant is Dr. Lanno, and

22 the other discussants are Dr. Allen and Dr. Johnson.

23 Dr. Lanno.

24 DR. LANNO: I think that a lot of what

25 Dr. Johnson discussed for Chapter 5 applies to Chapter 6,
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1 but we could go through these charge questions quickly.

2 And I can give you the answers that we came up with or at

3 least break into discussions here.

4 So for the first charge question: Does the

5 panel agree with the preliminary staff conclusions about

6 the evidence in the previous risk assessment in light of

7 current standards as presented in Section 6.2.

8 Unequivocally, yes, I think so.

9 The assessment is good based upon available

10 evidence and the previous risk assessments, the document,

11 the RAI document, that Chris discussed a second ago citing

12 a lack of general data within the (unintelligible), the

13 appropriate level of lead, and the environmental media may

14 be associated with adverse effects.

15 We don't have any more information on that,

16 so I don't see any reason that we should be changing it.

17 So I'll come back to that with a couple of points after we

18 go through the charge questions here.

19 Second, in the panel's view, does the

20 discussion in this chapter provide an appropriate and

21 sufficient rationale to support preliminary staff

22 conclusions that is appropriate.

23 I would say yes again. There's questions,

24 I guess, that remain. Dr. Allen and I discussed this

25 earlier this morning about relevance of the parameters
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1 that are used for describing the lead exposure in humans.

2 So the indicator, the level, the averaging time and the

3 form, whether or not they're exactly appropriate for -- in

4 an ecological context, but I don't think that there's

5 enough information to change that.

6 I don't know what it would accomplish, and

7 I think it would be a lot more work than it was worth

8 although the -- you know, the exact terminology may not be

9 exactly appropriate is probably good enough for what we

10 need.

11 A multimedia approach would certainly be

12 useful to account for legacy lead and other contributions

13 from different sources for the secondary standard. That

14 might be, again, a research need that we could talk about

15 later. But otherwise, I think that we would accept that,

16 you know, adequate information has been provided for

17 Charge Question 2.

18 And finally, Charge Question 3, do we have

19 any recommendations? I think not really at this point.

20 Perhaps for research needs a critical load approach would

21 certainly be a -- if we could apply it to U.S. situations,

22 that would probably be useful in describing some of the

23 issues that occur. The one thing I went back to, and this

24 is more of a -- maybe a little bit of a process issue like

25 Chris talked about.
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1 Reading the evidence that was considered

2 for, I guess, reducing -- let's see, three -- three years

3 back, would that be, so the last one reduced -- so the

4 last one reduced, and so reviewing the data for the three

5 -- I guess the three ISAs ago -- not ours, but the three

6 -- so 15 years ago, 10 years ago, when the decision was

7 made here that they basically said -- the panel suggested

8 that citing lack of data that would indicate appropriate

9 levels of lead in the environment that we could associate

10 adverse effects with, and as well as the panel's

11 suggestion that if the standard was reduced that

12 significant changes to current air concentrations would

13 have significant benefits -- this is directly from Chapter

14 6 -- that there would be significant benefits on the

15 magnitude of lead exposures.

16 I guess they're saying that we don't have

17 enough data, but reducing it would be good anyway. And

18 that was, I guess, for the previous panel discussion. And

19 for us, we're not changing anything. We're just --

20 obviously, as Dr. Murphy was saying, we're just agreeing

21 with what had been the reduction -- you know, keeping the

22 secondary standard similar to the primary standard is

23 going to be good.

24 It's not going to have any negative effect

25 and that's -- we haven't got enough data to change that or
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1 develop another secondary standard for any reason, so just

2 keep it as it is. I just found that, I guess, I don't

3 know, somewhat -- not distressing, but confounding that,

4 you know, we're just basing -- we're basing these upon

5 situations where we don't have enough data to make a real

6 decision, I guess.

7 But I really don't have much more to say

8 after that. I mean, I think it's fine. I'm trying to

9 pick -- nitpick here to try to get more discussion going,

10 but I think that in overall, Chapter 6 is fine. And I

11 liked the way they address the uncertainties.

12 There is one uncertainty that I think might

13 need to be added, and that's when we're looking at a data

14 for -- again, for our studies, the relevance of exposures

15 in media other than soils or water. So hydroponics and

16 other media that you might culture organisms in that I

17 don't think have any relevance to any real world

18 situation.

19 I mean, they can give you causal

20 information, but that's about it. So that would certainly

21 be an uncertainty. I don't know how much they -- that

22 much -- that type of data is considered in the development

23 of the secondary standards or not.

24 DR. FREY: Yeah, I think with -- you know,

25 regard to the framing of this so, you know, where one way
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1 of looking at it as a decision is the current standard

2 adequate. I mean, you could also ask the question, is

3 there evidence that there's need for a more stringent

4 standard -- frame it two different ways, and see if you

5 have a robust consistent set of answers.

6 But I suspect -- from your comments, it

7 sounds like there isn't evidence that there's need for a

8 more stringent standard. And based on what we currently

9 know or don't know, I think what I'm hearing is without a

10 -- maybe not a high degree of confidence, but we could say

11 the current standard is adequate. Okay. Dr. Allen?

12 DR. ALLEN: No comments.

13 DR. FREY: Okay. Dr. Johnson?

14 DR. JOHNSON: Pretty clearly, if you agree

15 with the approach and conclusions from Chapter 5, then

16 it's hard to object to what's going on in Chapter 6. So I

17 made, obviously, some pretty lengthy comments on Chapter

18 5. And, you know, if -- so with that in mind, I don't

19 really have a lot more to say here about Chapter 6.

20 I do think that -- you know, we said this

21 before, but I do think that if we can get to -- if we can

22 identify the key needs that are preventing us from taking

23 a critical loads approach to the ecological assessment,

24 and I don't know if there's a way to encourage research --

25 the research community to collect the data that's
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1 necessary for such an approach to be implemented the next

2 time this NOx process is undertaken, then that would be a

3 -- I think a big step forward, so that's all.

4 DR. FREY: Okay. Yeah. That's a good

5 segue because what I was thinking is I said we should talk

6 about the research needs, and maybe since this is the

7 fresh discussion, maybe we should go right into the

8 research needs related to ecological effects since that

9 actually is also mentioned in Chapter 6.

10 And I think -- so one issue is, you know,

11 we -- we can, as a panel, identify what -- you know, EPA

12 has listed some things on Pages 6.12 and 6.13 of the draft

13 policy assessment. And, you know, one way to approach

14 this is, is there a concordance that that list is

15 appropriate and inclusive. And, you know, if not, what

16 needs to be added, what needs to be deleted, what needs to

17 be changed?

18 I think to Chris's other point is, you

19 know, how do you move the research forward? You know, as

20 CASAC, we can certainly provide advice on the research

21 agenda. But obviously, we're not a funding agency, so we

22 can't fund the research.

23 But I think having a statement from CASAC

24 and also EPA's revised policy assessment -- and there's

25 nothing that prevents us from sharing that with, you know,
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1 NCER, and the Star Grants Program, or NSF, or the Health

2 Effects Institute, or other organizations, that this will

3 be public information.

4 So, you know, it's sort of an indirect way

5 of influencing the research agenda. But at least having

6 a, you know, external scientific, you know, independent

7 review panel identifying research needs -- I know often

8 funding agencies are interested in seeing what

9 organizations like us have to say about research. So it

10 may be partly a communication issue and then partly

11 whether they see that as -- as part of their priorities.

12 And, you know, there may be other agencies

13 that I didn't mention. So, you know, that's not

14 necessarily going to lead to an opening of the floodgates

15 of research funding, but that's something that we can at

16 least influence potentially.

17 So I guess having said that, I guess I'd

18 like to put Chris and Roman and Herb on the spot as far as

19 the -- the statements in Chapter 6 about key uncertainties

20 and area for future research and data collection and if

21 you have comments about what's here or other input that

22 you think should be considered in providing advice on the

23 research agenda. And maybe, Chris, I'll start with you.

24 DR. JOHNSON: So the -- one of the things

25 that's unclear to me when I read the ISA, in particular,
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1 was from the EPA's perspective in drafting that document,

2 what are the key limitations that prevent us from adopting

3 a critical loads approach to U.S. ecosystems?

4 When I read the ISA, the impression I get

5 -- and it's probably wrong, but the impression I get is,

6 Well, nobody's published any work applying critical loads

7 to United States ecosystems.

8 So I mean, is that really what you're

9 looking for? Are you looking for someone to show that it

10 can be done, or is it more of a data gap that there are --

11 that you -- in the ISA, you talk about European studies

12 where they have done this critical loads approach.

13 You know, so is it -- is the issue that

14 there haven't been authors -- you know, haven't been

15 authors that have tried to apply this in the U.S., or is

16 the issue that there are key data gaps that prevent anyone

17 from doing it in the U.S.? Or do you --

18 MS. TENNANT: Well, Meredith is sitting

19 back there, so if I get it wrong, she can fix it. So I

20 think there's a couple of issues. One is that the

21 critical loads information that's available in Europe is

22 difficult to apply to U.S. systems for a lot of reasons,

23 and so it's difficult to figure out how to take that

24 information and apply it to ecosystems in a way that we

25 could use.
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1 And secondly, the ISA needs to have

2 peer-reviewed literature that they can then look to to

3 establish critical loads. And then, of course, when you

4 get beyond that, you get to the point where we were with

5 NOx and SOx, which is having critical loads for enough of

6 the U.S. to be able to consider it for a national

7 standard.

8 So I think there's sort of three levels of

9 data that would be necessary to use critical loads. The

10 methodologies that they've used in Europe, I think, might

11 have some applicability, but no one has tried to use it on

12 U.S. soils with U.S. geology and U.S. ecosystems, as far

13 as I know. So those are sort of the data gaps that I

14 think we would need to fill.

15 DR. JOHNSON: So the -- could a critical

16 loads modeling approach be part of an REA?

17 MS. TENNANT: I think it could be. I don't

18 think there's any reason it couldn't be if there's enough

19 sort of peer support behind it to move it forward to the

20 -- to be able to apply it.

21 DR. JOHNSON: And would this panel -- I

22 mean, obviously, reconstituted for a new process, but I

23 mean, would this panel be that peer support, or would it

24 require something else?

25 MS. TENNANT: I think to move it into an
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1 REA -- and again, I'm going to talk about NOx and SOx for

2 just a second. There's such a huge amount of data

3 available for the effects of acidification on aquatic

4 water -- aquatic ecosystems, that there's a lot of work

5 that has already gone into developing a critical loads

6 model then that can be used using magic and some other

7 thing -- that can be used to look at critical loads for

8 different kinds of ecosystems.

9 And we still didn't necessarily have

10 universal coverage for the whole U.S. that really took

11 into account the different kinds of ecosystems and their

12 interactions.

13 I think with lead it gets far more

14 complicated as -- obviously, because of the legacy effects

15 and because of the long lag times and our basic

16 understandings of how lead is or isn't bioavailable or how

17 it moves through ecosystems. But in itself, if there was

18 a model that used lead and allowed us to move it through

19 different ecological compartments, we could -- there's no

20 reason we couldn't look at it.

21 It would have to be an evaluated model,

22 something that we had some peer review and some support

23 behind. And I don't know that this panel would be the

24 panel to give that type of peer review to the model

25 itself; but certainly, our interpretation of the model, if
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1 it got to that point.

2 DR. JOHNSON: Okay. So -- all right. So

3 it sounds like the -- to me, what I'm hearing is that the

4 ability to -- the ability to take -- so the models are out

5 there that can generate predictions of concentrations in

6 soils and water, but it sounds to me like what -- one of

7 key gaps for you is tying those to effects, to --

8 MS. TENNANT: Uh-huh.

9 DR. JOHNSON: -- on key receptor. So am I

10 hearing that correctly? So --

11 MS. TENNANT: That's right. And I believe

12 that those models haven't been widely evaluated, but I

13 could be wrong there. So there -- it doesn't -- I don't

14 think that those models have been applied in the way that

15 we would need to apply them.

16 DR. JOHNSON: Well, I think they -- I think

17 they're -- I mean, I think in Europe, you know, the

18 critical loads of models have been, you know, pretty --

19 gone through some reasonable peer review. The extent to

20 which they are appropriate for ecological toxicological

21 impacts, that may not be. But in terms of the basic

22 workings of the models, I think they're pretty -- been

23 pretty well-vetted, I think. I see Herb has his hand up

24 -- or had his hand up.

25 DR. ALLEN: If you want a descriptive
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1 model, the critical loads models that exist today are

2 wonderful. They're the things that any of us can use in

3 the classroom, these are the processes that go on, and so

4 on. When you look at what is in the models, they're

5 devoid of any mechanism whatsoever.

6 Perhaps the most important with respect to

7 lead is the question of aging. You know, this is -- in

8 the models, and in fact, in all the aging literature, it's

9 a number. Gee, it goes down by a factor of

10 (unintelligible) in a certain period of time.

11 Sorry, that doesn't allow me to extrapolate

12 to anything, even to the system that it was designed for

13 outside of the particular experiments that were conducted.

14 There are no chemical reactions, there are no physical

15 transport. Diffusion limitation, not mentioned. I mean,

16 anything that we would think of that would actually

17 control that process isn't there.

18 When we look at migration of, let's say,

19 lead through a soil column, you might think of

20 precipitation, you might think of complexation,

21 absorption. Those aren't in the critical loads models.

22 So I think the critical loads models are

23 very pretty. They can be highly descriptive for one site.

24 To use them to make policy on, no. I'll object to

25 anything that gets done with them, including in Europe. I
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1 don't think they're worth anything more than a nice

2 introductory environmental science lecture for the first

3 or second year. They do point to where research is

4 needed.

5 DR. LANNO: I don't know if this is where

6 Herb is getting at, but I think what we need is to have

7 some kind of mechanistic exposure models that, you know --

8 DR. ALLEN: Absolutely, yeah. There's no

9 mechanism.

10 DR. LANNO: I mean, the critical loads

11 models can describe loading rates, how much lead is

12 getting to the site through aerial deposition, but we have

13 to understand the interactions between the soil and the

14 water and the organisms.

15 I mean, so we need -- for risk assessment,

16 we need exposure numbers that -- you know, critical loads

17 won't solve it, but they'll get some -- get us thinking in

18 the right direction. The mechanistic models that describe

19 the interaction between soil and lead and bioavailability

20 in organisms is what we need.

21 DR. JOHNSON: Well, I -- you know, I think

22 the work that Ed Tipping has been working on in England is

23 very mechanistic in nature. It doesn't connect to the

24 ecological system well. He looks for specific

25 concentration targets, and that's really the endpoint, not
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1 bio -- not biological processes.

2 But I -- I mean, I guess I disagree, not

3 totally, but to a large extent with what you're saying,

4 Herb, because I think they are -- I think at least that

5 group anyway is working on very mechanistic approaches to

6 -- you know, to this problem in -- at least in soils and

7 water.

8 DR. ALLEN: Okay. So in WAM, we have hard

9 spheres. I mean, there are a series of problems in WAM

10 that are not dealt with at all. It describes things

11 reasonably well. It's descriptive, but you know --

12 DR. JOHNSON: I mean, there's a new one

13 that just got published that hopefully addresses some of

14 those things, but anyway --

15 DR. ALLEN: We've already recoded that one.

16 We had it almost a year ago. There are gaps.

17 DR. FREY: So I guess to summarize it, it

18 sounds like if one goes with the critical loads approach

19 that there -- the model -- the existing models are

20 descriptive but not predictive. And as Herb indicated,

21 they might help identify research needs.

22 I think Chris is indicating there is some

23 more mechanistic features to maybe some of their newer

24 models. Maybe that's the direction the models are moving

25 is to be a little bit more mechanistic. And I guess there
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1 would be an issue, you know, how far does that need to go

2 before it's adequate for EPA's purpose.

3 But I guess then does that translate into a

4 research agenda? Can the three of you formulate maybe a

5 few bullet points on, you know, what would move that --

6 the state of science forward with those -- with either

7 those models, if you see that as a promising approach if

8 it was developed appropriately, or do you see some

9 alternative that would be better?

10 DR. ALLEN: No. I think the critical

11 loads approach is the way to go. It also gets you into

12 the multimedia thing directly.

13 DR. JOHNSON: Uh-huh.

14 DR. ALLEN: Not sort of, but it directly

15 attacks -- it directly deals with a multimedia type of

16 thing. It deals with legacy lead, it deals with all of

17 these issues that we've been struggling with. That's the

18 framework, but it's a framework. It needs to be flushed

19 out.

20 And of course, as with any other research,

21 the question is what's the limiting thing -- what -- what

22 things are really most important, and how do you deal with

23 those?

24 DR. FREY: Right. So I guess maybe related

25 to that is, is it possible to answer that question now, or
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1 is it a research agenda to find out what is the answer to

2 that question in terms of what are the limiting factors

3 that most need attention?

4 DR. ALLEN: I think we know some of them.

5 Aging is very empirical. Absorption is exceedingly

6 empirical. We have some idea what goes on, and

7 bioavailability issues follow from that. I would hate to

8 see us try to tackle the bioavailability before we knew

9 the supply terms.

10 DR. LANNO: I guess in terms of what the

11 EPA really is after here is -- you know, for risk

12 assessment, they need an exposure estimate?

13 DR. ALLEN: Yeah, the exposure estimate --

14 DR. LANNO: Yeah, and that's -- so

15 ultimately, all the chemistry is not going to make much

16 difference unless we link it to the biology and get the

17 exposure as well.

18 DR. ALLEN: Right.

19 DR. LANNO: But it has to be linked with a

20 multimedia effort to look at all ecosystem receptors -- or

21 ecological receptors and all the different media.

22 DR. FREY: So Roman, since you're the

23 Chapter 6 lead, can we add sort of an implied for, which

24 is to, you know, comment on the --

25 DR. LANNO: Research.
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1 DR. FREY: -- the research needs, and could

2 you summarize?

3 DR. LANNO: Sure.

4 DR. FREY: Are there -- do the three of you

5 -- or actually anyone on the panel have comments on what's

6 written by EPA on Pages 6.12 and 6.13 as far as key

7 uncertainties and future research needs?

8 DR. LANNO: Yeah, I was okay with that

9 except for the issue of both the uncertainty related to

10 laboratory data that's generated for exposure in different

11 media than soils or water.

12 DR. ALLEN: Yeah, I think overall it's a --

13 you know, it deals with most of the issues pretty well.

14 DR. FREY: Okay. Yeah, because it --

15 DR. LANNO: It's daunting.

16 DR. FREY: Yeah.

17 DR. LANNO: It basically covers the entire

18 waterfront, yeah.

19 DR. FREY: Yeah, so I guess the question

20 is, it may cover the waterfront, but is it -- well, is it

21 necessary to cover the full waterfront? Are there

22 priorities among it? I mean, if -- would you be able to

23 prioritize among the things listed either by EPA or that

24 are discussed here? I think it would be helpful to

25 indicate, if possible.
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1 DR. ALLEN: I think if you started to

2 develop a critical loads approach and did some sensitivity

3 analysis within it, you would start to come out with what

4 was important.

5 DR. FREY: Okay.

6 DR. ALLEN: So I think as you develop that

7 process that will as -- not just as a framework for making

8 policy decisions, but it works just as well for making

9 research decisions.

10 DR. JOHNSON: Yeah, my motivation for

11 bringing this up to begin with was that if I understood

12 correctly the motive -- the reasons that one would

13 consider a new secondary standard or primary -- well,

14 primary is different -- but a secondary standard is --

15 would be if there were new processes that weren't

16 understood before that call into question the receptors or

17 levels that -- you know, that cause problems, or if there

18 was evidence that at the current standard or lower there

19 were, you know, negative effects.

20 And my point in some of the comments that I

21 made before was that we're not monitoring enough systems

22 to see effects in places where the air concentrations are

23 around that level. I mean, we're studying lead in the

24 environment in so few places in the United States that

25 we're just not going to catch that.
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1 So we've got to -- so if we can't -- if

2 we're not doing the work in the field to be able to

3 observe the effects directly, we have to have some way of

4 doing that. And a modeling approach is probably the only

5 reasonable way that we're going to do that. Herb's got

6 his hand up.

7 DR. FREY: Yeah. Sure. Go ahead, Herb.

8 DR. ALLEN: If you start down a critical

9 loads pathway, I think that you don't want it for lead,

10 you want in general. There -- in fact, I don't think lead

11 is the most important of the issues for which you might

12 need critical load.

13 If you look at nutrient loading, that is

14 even more empirical than what the lead stuff is. You

15 know, we don't have mechanistic models for how -- for

16 phosphorus loadings to embankments, you know. And so some

17 of the same processes that go on for one contaminant or

18 one material will also be there for other ones.

19 Numbers will be different, relative

20 importance of processes will be different. But the same

21 approach ought to work for a lot of different materials.

22 DR. FREY: So to tie that back to the

23 NAAQS, you know, other NAAQS pollutants where, I think,

24 there have been maybe somewhat similar discussions or for

25 example, NO2 and nitrogen deposition generally, sulfur
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1 deposition, do you see, therefore, synergies potentially

2 in a research agenda that might address multiple of these

3 criteria pollutants?

4 DR. ALLEN: Yeah, but I would go much

5 further than just the air quality ones.

6 DR. FREY: Sure.

7 DR. ALLEN: If you want to look at agency

8 needs in total, I think there are lots of other ones that

9 the same approach works for. So I think it's in -- I

10 think it is a much better way to look at contaminants. It

11 might get us out of the background level of PCBs is one

12 where I say, you know, now, the background level is zero,

13 and one is a manmade addition.

14 That keeps EPA from being in trouble

15 because, boy, would they be in trouble if they picked zero

16 because everything would be contaminated. So -- but I

17 think that if you take a good solid scientific approach

18 towards this, you'll move our understanding and our

19 dealing with contaminants in a much better way.

20 DR. LANNO: Sure. It would seem to me that

21 integration of, you know, NOx and SOx and metals would

22 make sense, you know.

23 DR. ALLEN: Yeah.

24 DR. LANNO: I mean, sure, any acidification

25 issues and things like that that would affect metal
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1 bioavailability and exposure.

2 DR. ALLEN: Uh-huh, yeah.

3 DR. FREY: Okay. Well, I guess I'm kind of

4 singling out the three of you or tripling out the three of

5 you since you're the eco effects experts. Do the three of

6 you feel comfortable as far as writing a paragraph or

7 either commenting on EPA or coming up with a list of

8 research needs and offering priorities among those.

9 And I think pointing out that as I

10 understand, you know, the critical loads approach would be

11 something worth looking at more broadly across pollutants

12 and also maybe accounting for nutrients, of course, as it

13 would affect the exposure pathway issues.

14 DR. JOHNSON: We can work together on that.

15 And given that we have very few comments on Chapter 6, it

16 probably would be appropriate to put them in there.

17 DR. FREY: Yeah. I mean, it seems like a

18 lot of the crux of the comments is that, well, the science

19 hasn't really moved forward. So helping to identify

20 what's needed to move it forward, I think, would be quite

21 helpful.

22 DR. ALLEN: Chris, you're right about the

23 science, but I would also point out that we -- at least I

24 don't see that there's any pressing need to do anything

25 different with regard to the secondary standard. I don't
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1 -- from what I see, I don't see organisms out there

2 massively dying --

3 DR. FREY: Okay. Yeah, fair enough.

4 DR. ALLEN: -- because of lead. So you

5 know, if you made the standard more restrictive, would the

6 environment be happier? And I don't see that the answer

7 is yes. I don't see that there's anything pushing me

8 toward saying making it more restrictive.

9 DR. FREY: Okay.

10 DR. LANNO: I'm not sure that, you know,

11 reducing that lead standard is going to make much of a

12 difference. I think lead may not be the critical element

13 as such that we're interested in here for improving

14 ecosystems.

15 DR. FREY: Okay. Well, then I think that

16 the angle of the expanding to other pollutants is also a

17 valuable aspect of identifying a research agenda because I

18 think -- I don't know. Personally, I think if we can help

19 EPA identify synergies across criteria pollutants or

20 across programs that that may also translate into maybe

21 more practicality of getting resources to do something.

22 Maybe that's wishful thinking but -- Joel?

23 DR. POUNDS: I just have a question for the

24 ecosystem folks that kind of comes from my ignorance. And

25 that is, do you need to anticipate anything about lead
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1 poisoning on top of climate change in terms of

2 co-stressors?

3 DR. LANNO: My initial response would be

4 that I think that there are more stressors that climate

5 change would affect that are much more important than

6 lead. I mean, just temperature changes themselves are

7 going to be enough of a stressor to -- and -- that will

8 cause shifts in ranges and responses of organisms.

9 I think lead becomes a minor component of

10 that. It's -- or irrelevant component even.

11 DR. FREY: Herb and then Chris.

12 DR. ALLEN: Probably the biggest effect is

13 going to be changes in pH. And changes in pH will affect

14 lead bioavailability, you know. In fact, if I had a

15 criticism that I haven't said with respect to the

16 documents in general, you point out, especially in the

17 ISA, what form of lead was added, you know, lead nitrate,

18 lead chloride. The answer is I don't care.

19 I'm much more interested in what the pH of

20 the system was. I mean, those are salts, they dissolve,

21 but as a -- for climate change, I think pH changes in the

22 environment are going to be a very large issue with

23 respect to bioavailability, not just of lead but of lots

24 of materials.

25 DR. JOHNSON: Joel, in terrestrial systems,
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1 the fate and transport of lead is so, so heavily tied to

2 carbon, organic carbon, that the link there is if global

3 climate change or regional climate change for that matter

4 affects soil carbon pools and distribution of carbon in

5 the soil that that could have a big impact on the ability

6 of soils to continue to retain lead.

7 And also if decomposition is increased,

8 then lead that is currently bound to organic matter could

9 become mobile again. So I think that's the connect in

10 terrestrial systems, the big connect for climate change.

11 And it's really unclear right now whether

12 temperate soils are likely to be bigger sinks or sources

13 in a changing climate.

14 DR. FREY: Yes. I think that's a good

15 question from Joel and probably something worth -- I mean,

16 I think I've heard that -- it could matter in some ways,

17 and it might be -- I think, therefore, it would be

18 appropriate to fold that into the panel response on the

19 charge question which would fall under 3 because 3 deals

20 with things beyond issues in the chapter, so you could put

21 it there.

22 Other panel discussion on Chapters 5 or 6

23 for the policy assessment on ecological effects?

24 DR. KOSNETT: Will they mention about

25 ammunition in the critical loads issue and the --
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1 potential contribution?

2 DR. FREY: Let's see. That would fall

3 under Chapter 5; is that right? So Chris --

4 DR. JOHNSON: I can put something in there.

5 DR. FREY: Yeah.

6 DR. KOSNETT: That would be great.

7 DR. JOHNSON: I've got it in my notes.

8 DR. FREY: Okay. Okay. How about if we

9 circle back to the human side of the policy assessment and

10 also talk about the research agenda? I -- maybe to kind

11 of warm us up for that, if we could ask the lead

12 discussants to maybe just briefly summarize what they saw

13 as like the top three most important points that they

14 envision being in the consensus response to charge

15 questions, that would probably tee up the discussion of

16 the research issues.

17 Which I know it's sort of a difficult thing

18 to do the day after a discussion to try to synthesis that,

19 but I'm confident that this panel can do it.

20 So I'm going to put Cliff, Rich and Rich on

21 the spot and then also Deborah. So I'll start with Cliff,

22 if you could offer, you know, what you see as the key

23 message to EPA from the panel on Chapter 1, and then maybe

24 you could offer how you might see that segueing into

25 research needs, if you could.
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1 DR. DAVIDSON: Sure. Okay. Thanks, Chris.

2 I guess the discussion that we had yesterday really

3 started with looking at the uncertainties and the unknowns

4 with regard to the huge amount of lead that currently

5 exists as a result of the legacy use of leaded gasoline.

6 We know approximately what those numbers are in terms of

7 how much lead was released, was emitted, from lead

8 gasoline as well as stationary sources.

9 The difficulty is that if we take a look at

10 the full body of lead concentrations in environmental

11 media, we cannot account for even a tiny fraction of that

12 lead that's emitted. We're talking about several million

13 tons of lead emitted in the U.S.

14 And as a result, we don't know what that

15 distribution of lead is. But the concern that I,

16 personally, would have is that there are going to be hot

17 spots in certain environmental media and at certain

18 geographical locations as a result of that huge amount of

19 lead released.

20 Since we don't know where those hot spots

21 are, it becomes very difficult to predict what human

22 exposure and ecosystem exposure might be to that enormous

23 amount of lead. So I guess in terms of a primary research

24 need, I would say looking at where that lead is likely to

25 have gone, what environmental media that lead is likely to
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1 be in, and where the exposed populations are of people and

2 exposure of ecosystems to that huge amount of lead.

3 DR. FREY: Okay. Great. Thanks, Cliff.

4 Rich Poirot, can I --

5 MR. POIROT: Well, I guess in terms of the

6 developing consensus recommendations we've been trying to

7 put together, several of them include things like just

8 asking for any kind of an update that the agency could

9 provide on some of the emissions controls that are

10 currently in place, which is not something that lends

11 itself to a research need.

12 And also asking for them to give us a look

13 to the extent possible at some of the new measurement

14 data, especially in the near airport data and so forth.

15 Again, not a research need. Although, we did try to add

16 in a line inspired by Ian's persistent recommendation that

17 we consider what is the consequence of regulating the

18 successful regulation of various large industrial sources

19 in this country, what's the consequence for lead emissions

20 elsewhere, which I think may be an appropriate kind of a

21 research need category that could be emphasized.

22 You know, there was -- I remember back in

23 the ISA also a chart that indicated usage of lead with

24 lead exports increasing, where are those going, and what

25 are they being used for and that sort of thing. So that
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1 was one area.

2 I think, you know, overall through the --

3 there's kind of a nice story that's told in terms of the

4 fate of lead in other media that gets into the details of

5 fine particle and course particle lead and being deposited

6 in wet and dry forms and one being soluble and the other

7 being insoluble and then getting deposited on soils and

8 working their way into soil pore water and ground water

9 and then surface waters and then sediments and so on.

10 But there's a part of that story, I think,

11 that has to do with what's the availability of that

12 deposited lead for resuspension, and that -- I don't think

13 we really are too clear about. Is all this roadside lead

14 right there just like it was 20 years ago? Is it being

15 covered over by clean air stuff that's more lead free? Is

16 it less available?

17 You know, somebody mentioned the climate

18 change implications. Well, we've had some severe flooding

19 in Vermont, for example, in the past year that has taken a

20 lot of roadside soil, put it on the roads where we then

21 kick it back up into the air. I don't know if there's

22 lead in it or not, but potentially, we certainly could be

23 disturbing a lot of historically deposited lead both in

24 sediments and roadsides and so on. That could be, I

25 think, a key research area.
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1 Also, as I've tried to emphasis in comments

2 earlier, the -- there's this distinction between lead in

3 particles in the air and lead in dust, and they have --

4 one obviously contributes to the other, but they're not

5 the same thing as each other. And they have different

6 particle size characteristics, and a little bit of a

7 better understanding of how the lead in the air in

8 different particle sizes works its way into that available

9 dust, I think, would be another area I could identify.

10 And then our final topic that we have been

11 pushing for is this need, we think, for an improved coarse

12 particle sampler that collects PLT or whatever. It would

13 be useful for lead and could also be further justified by

14 its application in a number of other uses.

15 There are other chemical contaminants that

16 have significant coarse particle fractions and especially

17 a number of biological contaminants as well that, you

18 know, having a sampler that more consistently and

19 precisely measures particles larger than 10 microns would

20 be desirable.

21 So those were, I guess, the things I could

22 think of that came out of our Chapter 2.

23 DR. FREY: Okay. Good. I kind of would

24 like to go through the different chapters. Could we defer

25 discussion until -- yeah. So what I would like to do then
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1 is ask Rich Canfield if he could summarize on the health

2 effects and exposure risk information.

3 DR. CANFIELD: So, yeah. I would like to

4 pick up on what Cliff said about hot spots in that I'm not

5 sure that the average lead level in children across the

6 nation is the important metric at this historical time

7 period. And I guess I was talking with Debbie and Susan

8 yesterday that if you talk to county health departments

9 about how many lead poisoned kids they're seeing, in some

10 counties it's just really quite staggering. But how many

11 of those kids show up in the NHANES is unclear and --

12 unclear to me. Someone knows, but I don't.

13 So anyway, I think characterizing and

14 focusing more on hot spots will give us a better

15 representation of the exposure risks out there and what

16 the significant exposures are.

17 So that's one, and that's -- so there's

18 child hot spots, and I'll leave it to others to talk about

19 potential adult hot spots. I am curious about the, you

20 know, remodelers, et cetera, doing paint abatement, how

21 well they're protecting themselves.

22 There's -- with respect to understanding

23 its effects on children, I think there -- we -- it's clear

24 that we don't know what the shape of the dose response is

25 at what now seem like extremely low levels. I have not
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1 been a lead researcher for as long as probably most anyone

2 here. But when I first got into this, it seemed like the

3 notion that anything below ten is worth talking about was

4 a little, you know, extreme.

5 And then we just keep going down. So when

6 we see some of these results with the averages, say,

7 around two and seemingly linked to some outcomes, we -- I

8 think we need to clarify what the past exposures are for

9 these kids, what does two represent during, you know,

10 primary school or preschool even.

11 And -- so that we can get a handle on what

12 the effects are because we simply don't know. And one

13 approach would be that, Oh, my God, you know, you can

14 hardly measure it. And, you know, it's not going to be

15 something that's going to be measured in health

16 departments, but we can measure very low levels. And I

17 think it's worth knowing what's going on at the origin in

18 terms of lead -- say, a lead IQ or other outcome.

19 So that's obviously a gap in the data. We

20 are guessing down there. It's just that we're guessing as

21 we were with the lower levels, you know, below ten, you

22 know, a little while ago.

23 The other issue, I think, is that we don't

24 know much about the effects of prenatal exposure. And so

25 if we're trying to understand the most sensitive receptor,
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1 I think that the theory goes that it should be during

2 periods of rapid development and during prenatal life when

3 fundamental processes and structures are getting set up.

4 But we don't have a lot of data on prenatal exposure. And

5 so that's, I think, a need.

6 And I think potentially some of the

7 epigenetic effects is an interesting direction to go there

8 just because we don't know a lot. So I guess that's where

9 I'm at.

10 DR. FREY: Okay. Great. What I -- I want

11 to try to go through the four chapters. I -- one thing, I

12 guess, I will make an exception for is I know Phil needs

13 to leave soon. So is there anything you want to say as

14 your parting remark?

15 DR. HOPKE: Just that the Chapter 4

16 discussion, I think, is the appropriate place that we

17 ought to be looking down the road at the potential for

18 eliminating the NAAQS or at least having a serious

19 discussion as to whether we can declare a victory and move

20 on and that there are more pressing public health issues

21 to be resolved and -- you know, are we really benefiting

22 the public by continuing to push the NAAQS when, you know,

23 at this point we don't think airborne lead has a lot to do

24 with the exposure and disease in people or even

25 ecosystems.
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1 DR. FREY: Yeah, I think that's a

2 discussion that, I think, as we talked about yesterday

3 goes beyond this review cycle and is not really aimed at

4 this review cycle but probably something to consider in

5 the next review cycle.

6 DR. HOPKE: Right. You know, again, we

7 have a couple of -- we still have a couple of broadly

8 dispersed sources that we want to take care of, and I'd

9 like to -- I'd love to see that happen, at least start

10 happening, over the next five years. But at that point

11 then everything else is easily covered by Section 109

12 regulations, and I don't really see the need for -- you

13 know, I think there -- as I said, there's better use of

14 the available funds to look at other things which

15 represent, I think, more serious threats to public health

16 than lead does now.

17 DR. FREY: Yeah. So I guess I'm just

18 trying to think operationally what -- so it's not, per se,

19 a research agenda item, but it is more like a policy

20 agenda item.

21 DR. HOPKE: Right. And that's why it needs

22 to be in the PA section.

23 DR. FREY: Yeah, and maybe the message for

24 EPA is to consider it. And, you know, maybe there's a

25 good reason to do it, maybe there's a good reason not to
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1 do that.

2 DR. KOSNETT: Chris, I don't think we have

3 a consensus on that. Okay. I don't think we do.

4 DR. FREY: Okay.

5 DR. KOSNETT: And I don't think we've

6 actually spent a lot of time, you know, giving a lot of

7 scientific thought to that.

8 DR. FREY: Okay.

9 DR. KOSNETT: And I'm very concerned with

10 that being a part of the recommendations of this committee

11 without much more time to weigh in on that.

12 DR. FREY: Okay. Yeah, that's fair enough.

13 That's fair enough. Well, maybe we'll --

14 DR. KOSNETT: I certainly think that if

15 Dr. Hopke wants to include that as an -- individual

16 comments that would be considered.

17 DR. FREY: Yeah, and I think it's there

18 already.

19 DR. KOSNETT: But I don't think that's --

20 DR. HOPKE: And we have in the past in

21 letters said, you know, there was -- there were members of

22 the panel or some reasonable fraction of the panel who

23 felt that this was blah, blah, blah. I mean, you know,

24 having been the chair and written those letters, we've

25 done that in the past where there was a discrepancy
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1 between the -- at least bring to the attention the fact

2 that it was discussed.

3 I think it's important enough that it

4 belongs -- that the fact that we discussed it, at least

5 partially, belongs in the letter and not just in my

6 comments, and I think I would push hard for that.

7 DR. FREY: Well, okay. Let's see. We're

8 sort of at an awkward moment in that Phil's leaving in a

9 few minutes, and we're kind of on a research agenda

10 discussion. So -- but I wanted to give Phil a chance to

11 say something before he left.

12 DR. HOPKE: I appreciate that.

13 DR. FREY: I kind of would like to finish

14 the research agenda discussion, and maybe we can circle

15 back even though Phil won't be here. I think we have a

16 good idea of Phil's views, so that part's probably not

17 controversial.

18 So what I would like to do then is ask

19 Deborah on Chapter 4 if you can offer your reflection on

20 some of the key points and how that segues into the

21 research agenda.

22 DR. CORY-SLECHTA: Well, I think sort of

23 going back to what Phil said, but we had a lot of

24 discussion yesterday when we were discussing Charge

25 Question 4 about what the apportionment -- what --
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1 especially with respect to children's exposure and how

2 much air lead influenced blood lead concentrations

3 currently. And there's some discomfort right now with the

4 NAAQS, but the bottom line was I think most people agreed

5 that we didn't really know at this point what that

6 influence was on blood lead concentration.

7 So I saw that as sort of a critical

8 component of the discussion that we had yesterday was

9 understanding that I think it would clearly influence the

10 discussion that we just had in terms of, you know, where

11 you want to go with the NAAQS.

12 So I think really understanding those

13 sources of exposure, how air influences blood lead

14 concentration, increases or decreases in air lead, at this

15 point would be a significant contribution.

16 DR. FREY: Okay. So with that, I think we

17 can open up for broader discussion on the heath effects,

18 and I guess, focusing for now on the messages for the

19 charge questions and the research agenda. Let's save the

20 issue of what to do with the NAAQS for -- well, let's do

21 this first, and then we can come back to that topic, if we

22 could.

23 I know Michael and Gail and then Michael

24 wanted to speak.

25 DR. WEITZMAN: So I have a couple of points
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1 about research. The first speaks to what Cliff and

2 Richard Poirot said. If you wanted to look at particular

3 hot spots, and you also wanted to listen seriously to what

4 Philip suggested, global warming is one of the major,

5 major environmental health problems that we confront.

6 And whether you frame it as such or not,

7 we've had a number of catastrophic events that the

8 mechanism that you two proposed when you talked about soil

9 erosion as a possibility and whether or not there's been

10 redeposition and whether or not that's bioavailable to

11 children I think is a practical, doable sort of project

12 and would yield profoundly important information.

13 I can't picture how you would generically

14 try to figure out where those hundreds of millions of tons

15 are, and any number of people have spent decades looking

16 at whether or not soil movement or moving soil as a human

17 activity influences children's blood lead levels. So that

18 even if we found it around the country, it raises

19 questions about what you would do.

20 But if you're going to kick up that soil

21 and then make it available perhaps through an air route

22 that ultimately becomes dust that becomes available for

23 children, I think that that a really important EPA, NIEHS

24 sort of issue.

25 The second thing I wanted to comment on is
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1 what Rick Canfield said about prenatal exposure. I don't

2 know if people here know, but CDC has issued a policy

3 statement on the screening of pregnant women in the United

4 States. And most of us don't know what to do if you find

5 an elevated blood lead in a pregnant woman. And there is

6 a rudimentary literature on the origins of blood lead in

7 the first six months of life, and it appears that much of

8 that is transplacental or breast milk, but it's

9 rudimentary.

10 And so that's difficult research to do, not

11 so much in terms of looking at the association between

12 maternal leads, how those change during pregnancy, how

13 those relate to blood leads of children. But when you

14 talk about developmental or epigenetic changes, that means

15 a commitment to long-term prospective studies. So that's

16 going to require -- that may be real science, but that's

17 going to require a real funding stream to be able to do

18 that.

19 And the third point is what Deborah pointed

20 out, which I could picture practical ways of looking at

21 the air lead, blood lead relationship. If you look at

22 what NHANES had contributed by adding dust lead levels to

23 recent generations of NHANES, you could suggest that the

24 National Center for Health Statistics also did air

25 monitoring over several subsequent years when you're
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1 collecting blood leads of kids and household dust leads,

2 and so you'd be able to look at the relationship

3 contemporaneously of air lead and dust lead.

4 And then you're still stuck with the

5 problem with cross-sectional data of how those -- that

6 lead level across the population of kids relate to IQ.

7 And then I don't know that one could possibly -- and I'd

8 have to defer to Rick Canfield and Deborah and Gail

9 whether or not one could ever add on to something like

10 NHANES more sophisticated neurocognitive testing other

11 than IQ.

12 It seems to me that that may be too big an

13 undertaking. But I think that the three big things that I

14 heard are doable in terms of research.

15 DR. FREY: Okay. Gail.

16 DR. WASSERMAN: If there is a concern about

17 early exposure and low level exposure, given the

18 difficulties in measurement of outcomes for very young

19 children and the instability that we can recognize, that

20 does mean concretely a commitment to a program of research

21 that's going to go at least until age seven, I would

22 imagine.

23 DR. WEITZMAN: At least.

24 DR. WASSERMAN: At least. So that's

25 important to consider. I think that going forward,
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1 though, we shouldn't just restrict to the measures of IQ

2 because the outcomes that we have looked at are all

3 inter-related, both the cognitive, and the behavioral, and

4 the cognitive to the behavioral. So there needs to be

5 some broader focus at looking at outcomes.

6 I do think that some of the neuropsych

7 things are doable in the context of something like NHANES

8 if you can do the DiSC as an interview, you could do

9 things like the CANTAB. You can do them in a delivery

10 with a remote -- we're making great strides with sort of

11 electronic assessment, computerized assessments, for kids

12 that can be done with just an iPad at the source.

13 So there certainly are ways to look at

14 things that would be more drilled down to brain regions,

15 perhaps, than something like the IQ which is a blunder bus

16 if ever there was one.

17 I would think that also in talking about

18 issues of flooding and movement that there's -- if we are

19 going to undergo periods of great weather instability, I

20 mean, living in New York, I can't imagine that the storms

21 that we've had have not really perturbed exposure in some

22 way, not just because you've got really risky targeted

23 focal sites but more global sites in urban areas.

24 So this -- I know there was just call for

25 proposals regarding the sort of consequences of Hurricane
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1 Sandy. I don't know if those things link up to the

2 environmental or the exposure end. I know them from sort

3 of the trauma end. But that would be -- you know, that

4 would be a wonderful mechanism, if there are cataclysmic

5 events to try to have a mechanism for funding from EPA or

6 some other agencies that would focus on what happens to

7 movement and what happens to the consequences of

8 exposures.

9 Multiple exposures have to, have to, have

10 to, have to, have to, have to be considered. Lead, yes,

11 is a nasty, but there's lots of nasties out there.

12 Certainly, the effects of manganese, which we know very

13 clear -- manganese even which seems to be so benign. It's

14 in baby food, but at very high levels, you have very

15 targeted impact on frontal circuitry that you can see in

16 the magnet.

17 So if you -- if you're assuming changes in

18 executive functioning with lead exposure, and you haven't

19 adjusted your manganese, I don't know what you're getting.

20 So this is very complicated at the multiexposure and the

21 sort of multioutcome levels.

22 DR. WEITZMAN: I just wanted to add to

23 what --

24 DR. FREY: Go ahead, sure.

25 DR. WEITZMAN: -- because I think it's
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1 really wonderful. But when Gail said up to age seven, if

2 you remember, yesterday, we had a conversation about

3 externalizing and internalizing behaviors. Those are not

4 likely to surface by the age of seven --

5 DR. WASSERMAN: Oh, yes, they can.

6 DR. WEITZMAN: Externalizing, you think you

7 can --

8 DR. WASSERMAN: Yes.

9 DR. WEITZMAN: And you think they have a

10 trajectory?

11 DR. WASSERMAN: Yes.

12 DR. WEITZMAN: A predictable trajectory?

13 DR. CANFIELD: I wouldn't say it's the

14 ideal age, but I think it's sensitive enough that you

15 would see -- you would start to see effects.

16 DR. WASSERMAN: You know, early onset of --

17 DR. WEITZMAN: But things like depression

18 -- things that we have in the table that we thought were

19 likely or causally-related, do you think that --

20 DR. CANFIELD: Well, externalizing in terms

21 of behavior problems, ADHD sorts of things, attention --

22 DR. WEITZMAN: But how about antisocial

23 behavior?

24 DR. CANFIELD: -- for internalizing -- you

25 know, kids have somatic complaints and --
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1 DR. WASSERMAN: Anxiety problems.

2 DR. CANFIELD: Yeah, anxiety and it's

3 not --

4 DR. WEITZMAN: But it's really your sense

5 that those predict across the lifespan, those types of

6 mental health problems?

7 DR. CANFIELD: It depends on --

8 (WHEREIN, unintelligible due to multiple

9 people speaking at once.)

10 DR. WEITZMAN: Hypothesis, I think.

11 DR. CANFIELD: It depends on the range of,

12 say, child anxiety. Well, Gail, I don't mean -- I

13 shouldn't be talking. I think he's --

14 DR. WASSERMAN: Well, there's a whole

15 construct of child behavioral externalizing conduct

16 problems that's early onset, you know, where 5 percent of

17 the population accounts for, you know, 80 percent of the

18 misbehavior in kids that's quite consistent into

19 adulthood.

20 In terms of anxiety and temperament issues,

21 yeah. I mean, it wouldn't be ideal, but if you could go

22 as far as seven, eight, early -- you know, early school

23 age. I don't think you've got to go to 20 to get a handle

24 on it.

25 DR. CANFIELD: I think it's often when the
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1 kids make the transition into school, and they have to

2 interface with a different social structure, you start --

3 DR. WASSERMAN: Right.

4 DR. CANFIELD: -- both their development is

5 at the stage where they can do that, but there are the

6 kids that can't adapt very well there and that -- so that

7 almost sort of brings out some significant behavior.

8 DR. FREY: Well, I think it's an

9 interesting discussion, but maybe we're getting a little

10 too detailed at this point.

11 DR. WASSERMAN: Right, right.

12 DR. FREY: I know Michael was waiting to

13 make some comments.

14 DR. KOSNETT: I had a few suggestions on --

15 with regard to the research agenda, and maybe some of them

16 find support and could be part of the letter. We talked

17 -- it's already in the document now about looking at

18 temporal trends in soil and -- of legacy lead, and I

19 thought that was a key point because just like Cliff was

20 saying, there's a lot of it. And the -- that would be

21 important.

22 I think it's interesting to potentially

23 find out more about the source of lead in diet and how

24 much of that is a legacy issue and how much of it is

25 potentially amenable to current interventions because it
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1 constitutes the large -- the majority of lead in exposure

2 to adults. And still, although not the majority for

3 children, it's not an insignificant contribution to

4 children.

5 And then with respect to certain health

6 endpoints, there -- you know, clearly the effects of lead

7 on cardiovascular mortality has emerged as a big concern

8 because, you know, of the fact that if you -- you know, if

9 you look at the NHANES data across the lowest terciles to

10 the upper terciles -- or was it cortiles? You know, there

11 was a 50 percent increase in some of these studies in

12 mortality, you know, across the -- in the general

13 population when you looked at people who had exposures

14 back in the range of the teens.

15 And that's -- you know, that's death.

16 That's a substantial endpoint. We talk a lot in

17 environmental health about, you know, effects of

18 substances on liver enzymes and you know, other small

19 biomarkers, but when you look at cardiovascular mortality,

20 it's significant.

21 Now, we don't have those levels present in

22 the general population. We do in the occupational

23 population, but we don't have it in the general population

24 today. But we don't really know the impact of lifetime

25 exposure to, say, blood leads less than ten on
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1 cardiovascular function because we haven't had the

2 experience with cohorts that have lived long enough to get

3 into the range where they start having cardiovascular

4 mortality who have grown up in the post-leaded gasoline

5 era and have had low levels of lead.

6 So that would be an interesting and a

7 concerning endpoint because if there's -- if the

8 contribution is not just at the teens but that there is an

9 effect below that on cardiovascular mortality and things

10 like hypertension, and even if the dose response is not

11 necessarily linear but even -- well, I don't know the dose

12 response.

13 But let's assume that there was responses,

14 that could have profound health implications, right,

15 because that's a -- you know, a small relative risk to a

16 very prevalent health condition translates into a lot of

17 morbidity in mortality. So that's something we need to

18 look at.

19 I think there has been some interesting

20 work done on the potential contribution of lead to

21 age-related neurodegeneration, and Debbie knows a lot

22 about this and some of the epigenetic effects that may

23 occur early in life. Again, that's something that we're

24 seeing now in our older population who have sustained

25 exposure, and we still have to sort that out, the extent
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1 to which lead contributes to that. But there's some

2 evidence for that. I think that should be an area of

3 ongoing research and especially looking at the extent to

4 which it may occur at the lower levels more prevalent

5 today.

6 I think the -- you know, we've gone back

7 and forth about the issue of reverse causation on renal

8 endpoints, I concur with -- I think the only way we're

9 going to probably finally figure that out is to do some

10 more research and perhaps to the extent we can look for

11 early biomarkers in nephrotoxicity or something like that

12 and seek them out.

13 But I don't know that -- I don't know how

14 productive that will be, but this new section on the ISA

15 that talks -- or the section in the ISA that talks about

16 reverse causation and renal -- agrees that the area --

17 that it's an area of dispute. And so obviously, it's an

18 area that research can hope to answer.

19 In terms of the biokinetics, it's been

20 acknowledged in the document that we don't know much about

21 the fate of -- or the biokinetics of lead in adolescents.

22 You know, we have a child model, UBK, which is really only

23 calibrated up to about age five. It's not intended to be

24 used in older children. Is that correct, age five?

25 DR. MURPHY: Seven.
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1 DR. KOSNETT: Seven. I'm sorry. But it's

2 not intended to be used in older children?

3 DR. MURPHY: It doesn't predict for older

4 children.

5 DR. KOSNETT: Okay. And then EPA was doing

6 some work on the all ages model, and that's sort of limbo,

7 right? Is that moving forward?

8 DR. MURPHY: I'm not the one to answer that

9 question. I don't know, Ellen, if you know. James Brown

10 knows. Go ahead, Ellen.

11 DR. KIRRANE: Yes, it's moving forward.

12 DR. KOSNETT: Okay.

13 DR. FREY: So she said, yeah, it's moving

14 forward. We have to talk into the microphone to get stuff

15 on the transcript, so -- yeah.

16 DR. KOSNETT: Okay. Well, that's good

17 because that will -- you know, the all ages model will

18 have a large -- you know, will make a valuable

19 contribution to our understanding of the environmental

20 fate of lead in humans. And I think that that -- I think

21 there is -- I think we can all agree that that's going to

22 be useful.

23 And then finally, one other point, and that

24 is in terms of research. One of the fundamental

25 approaches in occupational health to dealing with a
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1 hazardous substance and mitigating its effects is to

2 consider sub -- product substitution and reduced use, and

3 there have been efforts in recent years to look at -- not

4 just for lead, but for other things about, you know,

5 reduced use.

6 In the University of Massachusetts Lowell,

7 they have the toxic use reduction initiative. You know,

8 from Massachusetts is doing that. And Debbie -- I mean,

9 Susan knows about that. And in California, they have a

10 green chemistry initiative where they're looking at

11 potential alternatives to hazardous materials and ways to

12 reduce their use.

13 And I think an area for consideration would

14 be how we could potentially mitigate some of the impacts

15 of lead on environmental health by looking at use

16 reduction and product substitution. And I think we

17 consider that a huge amount of lead is still being used in

18 storage batteries around the world. And in fact, cell

19 phone towers, you know, in third world countries which are

20 really not even putting in grids but are just putting --

21 you know, I mean, wired grids, but are mainly going with

22 cellular service.

23 I mean, most of those are charged by lead

24 batteries, huge amount of lead batteries. So the global

25 use of lead -- and Ian, you probably know this -- is not
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1 decreasing, right?

2 DR. VON LINDERN: No. It's increasing.

3 DR. KOSNETT: It's increasing?

4 DR. VON LINDERN: It's increasing.

5 DR. KOSNETT: So that being in mind,

6 perhaps we could encourage green chemist -- you know,

7 further green chemistry initiatives that might look at

8 potential modification of that trajectory by the use of

9 safer materials.

10 DR. FREY: Okay. Great. Thank you. Let's

11 see. So --

12 DR. ALLEN: Quick question.

13 DR. FREY: Yeah, hold on one second. What

14 I should have done earlier is assigned some people to

15 summarize the research agenda. I think this fits under

16 Chapter 4, so I was going to ask the Chapter 4 group,

17 which is Deborah and Sean and Susan -- and if you need

18 notes, I've taken a lot of notes and can try to help fill

19 in gaps if you need help with that.

20 But since it falls under Chapter 4 anyway

21 -- and what I would like to do is talk a little bit about

22 what's on Page 433 to 435. But yeah, Herb, go ahead,

23 please.

24 DR. ALLEN: Michael, I hope that by safer

25 materials, we aren't talking about lithium batteries like
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1 used in the 787, are we? Not to be completely facetious

2 on it, there's a long history of lead storage battery use.

3 We certainly do know an awful lot about them. We

4 certainly can build secondary lead refiners that are very

5 low emitting.

6 I'm not sure that -- they're heavy. Charge

7 density is not as high as in some other materials, but I'm

8 not sure that other greener materials are overall better

9 in all applications.

10 DR. FREY: Yeah, I would suggest rather

11 than get into details on this that the general point, I

12 think, that Michael made was to look where appropriate for

13 alternatives. And lead batteries may actually be in some

14 sense a success story in some ways in terms of recycling

15 of lead.

16 DR. ALLEN: Yeah.

17 DR. FREY: And I'm not an expert on the

18 exposures associated with that. But clearly, we have a

19 pretty substantial infrastructure. In the last month,

20 I've taken several lead batteries back for recycling and

21 got new ones. And so, yeah, I think the details of that

22 probably need to be looked at more carefully.

23 DR. KOSNETT: Yeah, and some of those

24 batteries are going to Mexico now and not -- and the issue

25 isn't --
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1 DR. FREY: Yeah, sure. Sure.

2 DR. KOSNETT: But, yeah, I don't think we

3 need to get down in the weeds about singling out batteries

4 or not.

5 DR. FREY: Yeah.

6 DR. KOSNETT: And I recognize that that's

7 not a short-term solution.

8 DR. ALLEN: Right.

9 DR. KOSNETT: But that right now lead

10 batteries have a fundamental role in so many uses in

11 commerce. We're not about to change that quickly.

12 DR. ALLEN: Right.

13 DR. KOSNETT: But the whole concept of --

14 you know, of toxic use reduction and green chemistry and

15 thinking ahead of time when we develop materials about the

16 environmental health consequences of them is something

17 that we can -- that is starting to gain traction and that

18 -- why not encourage, in terms of research, that to be

19 applied to lead since it's such a -- a widespread

20 pollutant and it so many widespread health concerns at

21 levels that are found in -- that are currently encountered

22 in many people in the environment.

23 DR. FREY: Okay. Susan, yeah.

24 DR. KORRICK: Well, just a brief comment

25 that -- sort of compliment what Michael and Debbie said
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1 and also to reiterate something from yesterday, which is,

2 I think, another priority is to understand sources of lead

3 exposure in kids. That's all, that we just don't even

4 have basic understanding of where kids currently are

5 getting exposed to lead and to appreciate that there's --

6 it's a moving target. So there are new exposure sources

7 that come up periodically that contribute hot spot issues.

8 There's been some research recently on

9 spices as a source of exposure and spices being cut with

10 lead. And so there's variation in sources, but

11 understanding that better and understanding how to monitor

12 for new sources is an important area going forward, I

13 think, for research and for policy purposes.

14 DR. FREY: Yeah. Michael.

15 DR. WEITZMAN: I think it's a great idea.

16 I would just modify it that there is an older literature

17 on sources of exposure. But going back to the statement

18 about the changing demography of American families, you

19 know, we have huge numbers of people who have behaviors

20 that are brand new to our particular culture and country.

21 And so I really do think -- I'd second it that that's a

22 really important agenda item that I had not thought of.

23 DR. FREY: Okay. Great. Yeah, I wanted to

24 just reference in Chapter 4 in the policy assessment.

25 Section 4.4 identifies some key uncertainties and areas
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1 for future research, and I'm not going to go into all the

2 details of them. But just generally, there's, I don't

3 know, roughly eight or ten bullets here. And you know,

4 one is additional epidemiologic research involving

5 substantially sized populations with mean blood levels

6 closer to those common in today's population of young

7 children, and I think we heard some discussion on that.

8 There are some statements of uncertainty

9 which as written aren't clearly translated into a

10 research, but presumably, the statements about remaining

11 uncertainty and evidence about exposure circumstances

12 eliciting effects in older children would imply a need for

13 research.

14 But that -- I think that kind of is related

15 to Susan's point that just better understanding of lead

16 exposure in children and maybe -- I don't know if it's

17 worth subdividing into young children and older children.

18 Perhaps that's a useful distinction. So that might be

19 flushed out maybe a little more clearly in the document.

20 There's something about Alzheimer's like

21 pathology as a bullet point, and uncertainty remains with

22 regard to relationships of such pathology with altered

23 function behavior. And this is a lab animal, I guess,

24 observed effect. Whether -- I don't know if that's a key

25 research item. Next bullet is on epidemiological studies
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1 on -- I guess, have been -- indicate detrimental effects

2 of lead on sperm production and quality in occupational

3 cohorts. I don't know if the panel has a view on that.

4 Then there's a long list of -- there's a

5 bullet with a long list of sub-bullets on quantitative

6 estimation of blood lead levels in children would benefit

7 from research in areas such as factors affecting the

8 relationship between lead in ambient air and lead in

9 blood. I think we've probably touched on that a number of

10 times and other sub-bullets here, just to call your

11 attention to that.

12 The next major bullet is research on

13 relationship between lead in ambient air and indoor dust,

14 which we have talked about. Another research area that's

15 identified is understanding the spatial gradient of

16 ambient air lead concentrations in urban areas as well as

17 near sources, and then there's a sub-bullet.

18 And then research -- the last bullet,

19 research to improve understanding of relationship between

20 ambient air lead, outdoor dust, and surface soil lead,

21 including temporal dynamics.

22 So those are some things identified in the

23 document in the current draft. I guess what I would ask

24 the Chapter 4 group is to consider the appropriateness and

25 value of those recommendations and synthesis with the
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1 discussion we had this morning and if possible, offer some

2 priorities. And I don't know if that's something that any

3 of you are ready to do on the fly right now. But to the

4 extent you might, reflecting on the discussion this

5 morning, want to offer what's the number one -- or maybe

6 the top three things, and maybe we'll take a few minutes

7 to consider that.

8 I think that would be helpful input to the

9 charge question group. Does anyone want to offer some

10 thoughts on that? Susan.

11 DR. KORRICK: That's hard. I -- I guess

12 there are sort of different ways to prioritize. It

13 depends if the priority has to do with facilitating

14 information that's relevant to regulation versus public

15 health. I mean, I know they're related, but the

16 priorities might be different.

17 DR. FREY: Well, I would view it -- yeah, I

18 would view it as, you know, five years from now when we're

19 -- we or some other group like us are reviewing the policy

20 assessment, are we going to be more satisfied that

21 information has been developed that supports the decision.

22 So that would be kind of a very operational focused view.

23 I mean, yeah, certainly there's much broader implications

24 and a broader agenda related either to lead or to either

25 of these endpoints. I would tend to think that the --
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1 this Chapter 4 is really talking about research that would

2 inform, you know, the ISA, the REA, and the policy

3 assessment in the context of the lead NAAQS.

4 DR. KORRICK: Yeah.

5 DR. FREY: And that probably would be the

6 best way to prioritize for this purpose.

7 DR. KORRICK: Yeah, I mean -- then sort of

8 off the top of my head, and I'm just saying this to

9 stimulate discussion. I would say the three top

10 priorities would be a better understanding of the air

11 lead, blood lead relationship; better understanding of

12 pathways of exposure to lead, particularly in vulnerable

13 groups like younger kids; and better understanding of the

14 health effects of low level lead exposure in kids because

15 we've sort of all decided that's the highest risk group.

16 So those would be my three -- I think, you

17 know, I'm just saying that to get other people to chime

18 in. Those would be the three things that I think are most

19 lacking in being able to move forward and have information

20 that would be relevant to reviewing the standard in the

21 future.

22 DR. FREY: Okay.

23 DR. KOSNETT: Well, you know, I think, you

24 know, we know -- I think that we're pretty clear that the

25 neurocognitive effects of lead at low dose are probably
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1 likely to remain the key concern.

2 DR. KORRICK: Right.

3 DR. KOSNETT: But as Rich mentioned, you

4 know, the dose response at the very low levels that we're

5 seeing today, you know, going from one to two, let's say,

6 and things of that nature, you know, that obviously we

7 haven't had a lot of chance -- there's some research on

8 that, but there's not a lot because -- and so you know,

9 because we're down at those levels, that's where we need

10 to look.

11 One of the points that -- and maybe -- and

12 perhaps Phil Goodrum at some point could help us

13 understand this, but you know, where it says in one of the

14 bullets that you read, Enter individual variability in

15 blood lead levels. When someone has a certain exposure,

16 you realize that a lot of the key ways that this whole

17 document is generated and -- I mean, in terms of the

18 policy assessment and in terms of the increment of blood

19 lead is, you know, we look at the air to blood

20 relationship, and then we put that into the IEUBK, and we

21 say, Okay, this -- you know, I mean, this much air level,

22 this much exposure's going to create this increment in

23 blood lead, right?

24 DR. HAYS: Yeah, but not (unintelligible).

25 DR. KOSNETT: Not in the -- just using the
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1 slope. Okay. In the models that they did, they didn't

2 look at --

3 DR. HAYS: Well, Deirdre can answer this,

4 but it depends upon the scenario. I think the scenarios

5 involved in using IEUBK and (unintelligible).

6 DR. MURPHY: Sure. So just to quickly

7 recap, if you will. So we have looked at the -- the way

8 we tend to do some of these reviews is evidence-based

9 analyses and exposure risk-based analyses. And with

10 regard to the evidence-based analyses, we've focused on

11 reviewing the evidence within this evidence-based

12 framework in which we've collapsed that -- those pathways

13 of lead in the air to lead in blood into these

14 air-to-blood ratios and then we integrate that -- those

15 estimates with estimates of the concentration response

16 functions for IQ loss. That's a way of viewing the

17 evidence-based information, the evidence.

18 Then in the exposure risk analyses we've

19 done, we used the IEUBK to predict blood concentrations

20 based on different exposure circumstances in these

21 multiple case studies.

22 DR. KOSNETT: That's right, and it was the

23 latter that I was referring to the use of the IEUBK. But

24 you know, the IEUBK comes in so often when we're talking

25 about lead risks, and so we've often seen different
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1 geometric standard deviations put into that model. You

2 know, Superfund recommends 1.6, I think, but other times

3 there's larger numbers put in there.

4 And anyway, to the -- that has such an

5 implication often for risk assessment and risk management

6 in the modeling that -- to the extent to which we

7 understand that, I think, is going to have -- or improve

8 the research in that is going to be significant.

9 Would you agree with that in terms of your

10 approach in doing a lot of lead-related --

11 DR. MURPHY: Well, that is important to the

12 risk modeling work. So yes, to the extent you rely on the

13 exposure risk information, that came into play. In this

14 bullet, it's talking about -- these sub-bullets are all

15 talking about inputs to the REA that were important.

16 DR. FREY: Okay. Any other thoughts on any

17 key research needs? Sean,

18 DR. HAYES: I'll just second Susan's

19 recommendations.

20 DR. FREY: Okay. Good. Other thoughts on

21 research? Yeah, Joel.

22 DR. POUNDS: I think we could raise this

23 discussion up just one level higher and say that we really

24 need to know a lot more about gene and the lead

25 environment for toxicity interactions and especially as
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1 it's driving interindividual variability and

2 susceptibility. So there's a whole host of, you know,

3 21st biology, you know, molecular epidemiology, you know,

4 non-coding RNAs, (unintelligible) technologies and

5 epigenetic processes and such that really have not been

6 incorporated into what most of us define as a pretty

7 important, you know, public health problem.

8 And I think -- I would just think that we

9 need to ask the question of what drives interindividual

10 variability and susceptibility, and then think of -- you

11 know, outside the box about what data do we need in the

12 next few years to kind of address that for public health

13 and clinicians.

14 DR. FREY: Okay. Yeah. Well, Susan and

15 then Rich.

16 DR. KORRICK: Just so -- I think the

17 principle of looking at differences in susceptibility is a

18 really key piece, but I'm a confessed skeptic about a lot

19 of genetics research because it's incredibly resource

20 intensive, and I feel like it's oftentimes not very

21 productive.

22 Even though in theory it sounds good, there

23 are very few examples of how genetics research has really

24 elucidated, disease risk accepting in the case of pretty

25 well-defined single gene diseases, and the outcomes we're
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1 looking at lead are very complicated. So I just want to

2 just put a comment in terms of skepticism about the

3 specifics but not the principle of what you're saying.

4 DR. FREY: Okay. Joel.

5 DR. POUNDS: So I agree with that.

6 Genome-wide association studies have pretty much been a

7 failure, and lead is a very hard case to design a good GWA

8 study. But the technology and the science is evolving.

9 All right. And it doesn't mean that we shouldn't think

10 about how we could possibly -- you know, the creative

11 folks somewhere could come up with a good approach.

12 DR. KORRICK: Fair enough.

13 DR. FREY: Okay. Rich.

14 DR. CANFIELD: I think this last discussion

15 on the genetics is -- covers one of my points I was going

16 to bring up. The other is though that there does -- I

17 think there does need to be more work done on looking at

18 more sensitive endpoints in the domain of emotion and

19 behavior regulation. And I think it intersects with the

20 stress issue as in Debbie's research and with the genetics

21 issue.

22 So you know, I think many of us are quite

23 surprised that IQ has just been so reliable as a measure

24 because it's -- we don't really know what it is, and it

25 would be nice to have more specific measures.
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1 And I think most of us have thought there's

2 more sensitive measures out there, but I -- you know, part

3 of it might be the psychometrics that saves our bacon with

4 IQ tests, but it might be other issues as well.

5 But I think in the domain of emotion,

6 there's, you know, interesting animal work, and there's,

7 you know, an endpoint in terms of the behavior conduct

8 problems. And if we could understand sort of the

9 emotional system and self-regulation, we might be able to,

10 I think, come up with a more sensitive endpoint.

11 DR. FREY: Anything else?

12 (No response.)

13 DR. FREY: Okay. Anything more generally

14 on the policy assessment?

15 (No response.)

16 DR. FREY: So in terms of our advice to the

17 administrator, I think we pretty well discussed for the

18 primary standard yesterday that we agreed, you know, in

19 principle with EPA's -- OAQPS's recommendation to retain

20 the current standard.

21 I think we heard the same thing on the

22 secondary standard, but we haven't actually, I think,

23 specifically talked about it as a panel. So I just want

24 to reach -- I guess to close the loop on that, just see

25 if, in fact, as a panel we're comfortable essentially
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1 providing support for staff's recommendation on retaining

2 the current secondary standard, and are there any concerns

3 with that advice? And I don't think I heard any in the

4 earlier discussion this morning.

5 So what I would propose is in the letter to

6 the administrator that CASAC would advise the

7 administrator in support of the staff conclusions on both

8 the primary and the secondary standard to retain the

9 current standard. Are there any comments on that?

10 (No response.)

11 DR. FREY: Okay. All right. Good. So I

12 think in terms of our key business, that's kind of the

13 bottom line. We did have some discussion which may be

14 incomplete as far as the issue about looking forward with

15 the lead NAAQS and whether we're at a point where we want

16 to advise EPA on considering alternative ways to address

17 lead that may not require a NAAQS.

18 Maybe it's too early to do that, maybe it's

19 not appropriate to do that. But it's just an issue that's

20 come up for discussion, so I did want to come back to that

21 just to see if there is any message from the panel on

22 this. And it may be that there's no consensus on it,

23 maybe there is a consensus. So I guess I wanted to get a

24 little bit more input from the panel on that issue.

25 MR. ALLEN: Yes.
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1 DR. FREY: Yes.

2 MR. ALLEN: I agree there's no consensus at

3 this time. One question I have absolutely no answer to is

4 if we were to come towards a consensus, what's the

5 process? I don't think we've done this before. Would it

6 be left in hibernation until the next time EPA starts the

7 process of a lead NAAQS review several years from now?

8 It's just really a process question even if we had

9 consensus, which we don't.

10 DR. FREY: Yeah, I suspect it would -- it

11 would have to involve EPA staff. I mean, I think it's not

12 something that we would want to just unilaterally as CASAC

13 -- I mean, we could, but it would probably make more sense

14 that this be something where we get input from the staff

15 on whether they see this as something they want to

16 recommend to the administrator, and then we could get

17 their input on the procedural aspects. And I don't think

18 we're at that point right now.

19 So it would really be more an issue for the

20 next review. Is that something that should come up in the

21 discussions? And either we could leave it to the agency's

22 discretion to initiate that if they choose to, and that's

23 one way to handle it. Or if we want to say something

24 proactive indicating interest in that, we could do that.

25 Yeah, Rich.
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1 DR. CANFIELD: I may be more ignorant than

2 the rest here, but I don't really know what it means to,

3 like, get rid of the NAAQS. Does that mean we don't care

4 about air lead anymore?

5 DR. FREY: Well, not exactly.

6 DR. CANFIELD: Okay. Well, if someone

7 could just kind of describe for -- unless I'm the only one

8 who's -- doesn't --

9 DR. FREY: Yeah. Well, I'll describe --

10 and I'm not advocating actually one way or the other. I

11 think it's an issue that's worth discussing, which is why

12 I'm suggesting we discuss it, but I don't really have a

13 personal opinion.

14 So I think picking up on some of what Phil

15 said, there are other standards that affect lead

16 emissions. And there are things going on that maybe in,

17 you know, 5 or 10 or 15 years, we will see possibly the

18 phase-out of lead from aviation gas, which right now is

19 the largest source of primary emissions, direct emissions.

20 So if those things came to fruition -- and

21 then there is a mechanism under the -- I don't remember

22 the section of the act, but basically under the National

23 Emissions Standards for Hazardous Air Pollutants, lead is

24 one of those pollutants. And there are stationary source

25 standards for a large number of source categories. And so
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1 that would, in principle, address or could address

2 stationary source emissions of lead. And those standards

3 are a mix of a technology-based and a risk-based standard.

4 So they kind of started out under the 1990 Clean Air Act

5 Amendment as a technology-based standard, but then there's

6 a second step to that that is referred to, I think,

7 informally, as residual risk. And I think it has a more

8 formal name -- to look at given the implementation of the

9 first phase of those standards, is there still

10 unacceptable risk to exposed populations, and therefore,

11 should the standard be made more stringent.

12 So those are some mechanisms in place that

13 are addressing sources. Now, of course, the NAAQS is an

14 air quality standard, not a source standard, and the NAAQS

15 is explicitly to protect public health. And, you know, I

16 think an argument we heard in favor of, you know, maybe

17 continued retention of a lead NAAQS is, well, it would

18 prevent things from getting worse in the future. It would

19 prevent new sources from coming into existence that maybe

20 might lead to health impact.

21 And I guess the question, you know -- it

22 may be a question more for EPA than for us is, well, would

23 those sources be caught by other standards, and what are

24 the resource issues of having a NAAQS versus these other

25 standards. I mean, one resource issue is, well, the
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1 process we've just undergone to do an ISA -- well, EPA,

2 you know, resources to do the ISA, the PA, and so on, and

3 could that be better spent elsewhere. And that assumes,

4 of course, a resource limited world.

5 So that's sort of beyond our, I don't know,

6 knowledge or domain. I think some people have the

7 opinion, for example, that, well, there are other

8 pollutants that are in the ambient air that maybe are more

9 important than lead, and that may not argue to removing

10 the lead standard. It may argue to adding other criteria

11 pollutants. And some of the common examples would be like

12 benzene or formaldehyde and a few others that I'm not

13 remembering off the top of my head.

14 So I don't know if that answers your

15 question. So Michael and then Rich.

16 DR. KOSNETT: Yeah, I would add to my

17 comments yesterday, and you mentioned one of them that the

18 standard has had great impact, I think, in reducing lead

19 emissions and in keeping the potential for elevated lead

20 emissions in check.

21 So I think that -- I think it's very

22 important to retain the standard. And then you raised the

23 point about the cost associated with going through this

24 whole process of integrated science assessment and --

25 DR. FREY: Well, and there's also the
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1 monitoring, and the designation of attainment, and so on,

2 and --

3 DR. KOSNETT: Right. You know, one of the

4 things that it's -- I think it's worth noting, and Chris,

5 this gets to what -- one of the things you said yesterday

6 about, you know, the broader picture of what these -- this

7 whole integrated science assessment produces. It's a

8 tremendous -- it has a tremendous value and impact beyond

9 just air emissions.

10 I mean, clearly there's a considerable

11 concern with lead in the environment, not necessarily from

12 contemporary lead emissions. But, you know, I mean, it's

13 -- if you look at ATSDR's list of -- priority list of

14 substances based on their prevalence and impact on health,

15 I think lead is 1 or 2. I think arsenic is Number 1 and

16 lead is Number 2, or is it lead that's Number 1? It's 1

17 or 2, and it has been for a long time.

18 And, you know, there's still a lot of

19 considerable concern over the impacts of lead in

20 occupational settings, and there's concern about lead in

21 water. You know, the drinking water standard is not

22 really an MCL. All right. It's a drinking water standard

23 in the sense that it's 15 micrograms per liter, but that

24 only applies to water systems, right? Maybe I'm wrong,

25 but it's 90 -- 90 percent have to be less than that, but
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1 you know, there's -- it's a multimedia pollutant, and the

2 -- I think it's worth noting that the value of all the

3 work and research that goes into collecting and reviewing

4 the science has implications beyond just the air emissions

5 concerns.

6 And it has tremendous value internationally

7 because people -- I think we're doing more about it,

8 studying it, and categorizing it, and scientifically

9 reviewing it in this process than is being done elsewhere

10 in the world. And there's a tremendous amount of lead

11 still used in commerce, so the valuable information that's

12 learned here has global implications.

13 I'm -- I think that it's something that we

14 shouldn't lose sight of. Certainly Ian's brought that up

15 multiple times, and I agree with him on that.

16 DR. FREY: Rich. Well, I thought one of

17 you had your hand up, but --

18 DR. CANFIELD: I didn't.

19 MR. POIROT: I did.

20 DR. FREY: Okay.

21 MR. POIROT: I guess a couple of points

22 that, to me, weigh in on the side of us not taking a stand

23 on that in this current review process. One would be

24 that, I think, if -- what -- reflecting on the history of

25 the lead NAAQS, the predominant source category has
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1 changed so many times over the history of our controls,

2 and that's sort of a -- I think a really good fit for what

3 a NAAQS should be and how it should work.

4 So I think the evidence of the varying

5 dominant sources and the way in which we've controlled

6 them over time is good evidence that it's an appropriate

7 pollutant to consider that way.

8 Along somewhat similar lines, I think it's

9 in some ways only when we start to get lower, measurable

10 blood lead levels that we can do the epiwork to understand

11 effects that are occurring at lower and lower levels, and

12 I think the same is true for other criteria pollutants as

13 well. As we reduce the concentrations, we see, and only

14 then can we easily see with some of those tools the

15 effects at lower levels.

16 Another thing I remember from the last

17 review cycle, somebody just making the observation that,

18 you know, this has been this great success story. We have

19 reduced ambient air concentrations by more than an order

20 of magnitude, you know, maybe a couple, but at the same

21 time, the ambient concentration levels remain a couple of

22 orders of magnitude higher than those under which life

23 evolved, you know. So what do you mean low? I mean,

24 yeah, they're lower than they were, but they're higher

25 than they used to be.
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1 So then the last reason, I guess, to invoke

2 is that we just started and initiated a lot of new lead

3 monitoring, specifically looking at source impacts and

4 different kinds of sources. And I think it would be

5 completely premature to prejudge that and say we know it's

6 not going to show anything. So those would be my reasons.

7 DR. FREY: Okay. Yeah. Good. Yeah, Sean?

8 DR. HAYS: (Unintelligible.)

9 DR. FREY: Okay. Yeah.

10 DR. VON LINDERN: Occasionally, I find

11 myself an optimist, so I feel like I should speak up. I

12 agree with -- I thought Rich captured the technical side

13 of this quite well, but I'm wondering if there's not

14 really a consensus developing here because Cliff talks

15 about a legacy problem. Herb really points out a big one,

16 I think, is that we have a changing environment that can

17 have a major impact on that legacy.

18 I could give a little side story. I won't

19 right now, but the change in bioavailability of lead in

20 the natural environment is a real time bomb that's coming.

21 Michael points out that we love lead. He's

22 right about that. This society loves it because of the

23 chemical properties that it has and the uses it has in

24 commerce. So we're going to continue to mine, we're going

25 to continue to produce, and we're going to continue to
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1 distribute more lead in the global environment. Those

2 things we don't understand. Those things are the research

3 areas we need to move in, and we need to understand more

4 about how the past regulatory actions that we've taken

5 have influenced that distribution and recycling of lead in

6 our environment.

7 And we need to know more about that before

8 we could consider changing the NAAQS, which has been a

9 really key and important component in that, not just in

10 the U.S. but internationally as well.

11 DR. FREY: Okay. Well, let's see. Sean, I

12 think -- and then Michael.

13 DR. HAYS: Well, I feel like since I

14 mentioned it yesterday, I'm kind of one of the ones that

15 advocated for maybe lead not being appropriately

16 controlled through the NAAQS anymore, so I'll give my

17 arguments for it.

18 But I want to say that I totally agree with

19 everything that's been said. There's no desire whatsoever

20 to stop regulating lead. I kind of feel like we've come

21 to a -- there was a time when the NAAQS made sense for

22 lead because of the way it was being used and how that was

23 the dominant source for our exposures.

24 My concern is that now we're, in essence,

25 bringing a knife to a gun fight. The NAAQS isn't the
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1 right mechanism for controlling the exposures to lead that

2 are of importance. It may be part of it, but it's not

3 necessarily the right tool anymore.

4 And so I don't advocate for doing away with

5 the NAAQS, but I advocate for a more holistic multimedia

6 approach to addressing lead exposures, which still are an

7 important source of public health concern for the

8 environment even in the U.S.

9 So that was my main point for saying that

10 -- and I would only do away with listing lead in the NAAQS

11 if there was some other program it could be kicked into so

12 that it could be handled from a multimedia perspective,

13 but I don't know what that is. I don't know how EPA could

14 tackle that.

15 You know, I know they've got the dust

16 committee, they've done the dust remodeling abatement

17 program that we had advised them on last cycle, and there

18 are several other initiatives that are ongoing that, you

19 know, are starting to poke at some of the other important

20 sources. But it would be nice to see EPA take an

21 integrated holistic approach to lead in a multimedia

22 basis.

23 Now, through the NAAQS review process,

24 we're dealing with some of those -- we're dealing with all

25 of the issues. But I feel like, you know, the primary
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1 focus is air, and we're trying to figure out how air

2 impacts indoor dust, and we're trying to figure out how

3 outdoor soil impacts air. You know, it's always tied to

4 air.

5 Well, air isn't the main factor anymore, I

6 don't think, but that's part of the problem, you know. We

7 need to know better how multimedia -- how the multimedia

8 sources are impacting exposures, which ones are the most

9 important, and then how do we tackle those from a societal

10 perspective in a holistic approach? That was my

11 discussion about how the NAAQS may not be appropriate

12 anymore.

13 Now, the other concern I have is that, you

14 know, this process that we've been going through in these

15 NAAQS reviews seems a little predetermined, yet we're

16 spending a lot of time going through reviews. I mean, we

17 practically could have reviewed this policy assessment

18 when we got the first draft of the ISA. I don't think

19 going through two review -- three reviews of the ISA made

20 it all of a sudden us -- all of a sudden now be able to

21 review the policy assessment.

22 So I guess one of my recommendations is,

23 you know, I guess, talking myself into this that we don't

24 de-list lead from the NAAQS. We recommend the agency take

25 a more holistic, multimedia approach to regulating lead
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1 exposures. And to that degree, we streamline the NAAQS

2 review process for lead.

3 It may not apply to other compounds, but

4 for lead, I'm not sure that we need to do this every five

5 years or that we need to go through multiple review of the

6 ISA or REA or policy assessment. We can streamline this

7 quite a bit, but have a regular trigger so that if some

8 new research pops up that all of a sudden makes us

9 realize, holy crap, we -- sorry, we messed this up, and

10 now we've got this new science that suggests that we

11 really need to lower it, we do have the mechanism to then

12 go through that process and stay on top of airborne lead

13 exposures.

14 DR. FREY: Yeah, just a couple of comments.

15 I think actually there is a statutory mandate for

16 five-year review.

17 DR. HAYS: Right.

18 DR. FREY: I'm looking at Lydia and Karen

19 and -- so I think -- and there is a requirement for a

20 criteria document as was pointed out yesterday. So there

21 are some things that are required given the existence of

22 the NAAQS.

23 DR. HAYS: Yeah, I understand.

24 DR. FREY: And if those requirements are

25 not met, then the agency is open to judicial review is, I
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1 guess, the polite way to say it, but -- so I don't know,

2 Lydia, if you want to say something about that.

3 MS. WEGMAN: Well, you're absolutely right,

4 Chris. We have a statutory requirement for a five-year

5 review and revision, if appropriate, of the air quality

6 criteria and the -- yeah, what it says is review and

7 revise, if appropriate.

8 So I think, you know, the statute certainly

9 envisions the possibility that revision is not

10 appropriate, and we do have to review the air quality

11 criteria, which is what the ISA is. But that doesn't mean

12 we can't do some more streamlined version of it.

13 But as Chris says, we do have this

14 obligation under the statute to review and revise, if

15 appropriate, both the air quality criteria and the

16 standards, with CASAC advice, review and revise every five

17 years. So that is something we have to do under the law

18 as it's structured right now.

19 And while I have the mic, I did just want

20 to observe that we do have a lead strategy across the

21 agency. I mean, we're obviously talking here about the

22 lead NAAQS only, but almost every office within the agency

23 has some lead activities ongoing to try to address the

24 multimedia aspects of it. The agency is very much aware

25 of the multimedia components of lead, and we've had a
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1 strategy in place for a number of years to try to do that.

2 And in fact, we were talking yesterday when

3 we issued the last lead NAAQS in the notice itself, we

4 talked about the agency's multiple strategies. And we

5 will put that into the final policy assessment so it's

6 clear that we do have multimedia strategy in place. It

7 doesn't mean that we can't do more, but I did want to

8 reassure you the agency does look at it in a multimedia

9 way.

10 DR. HAYS: Thank you.

11 DR. FREY: Yeah, thank you, Lydia. And

12 yeah, I think the issue of -- you know, we kind of went to

13 a big issue of, you know, should -- how long should the

14 life be of the lead NAAQS to a more practical issue of

15 given the need for a five-year review cycle, are there

16 ways to streamline it.

17 And I think -- I don't know that there's

18 any answer to that right now. You know, in some ways --

19 you know, I've thought a little bit about this, and you

20 know, as Lydia points out, there has to be a five-year

21 review of the criteria and also to revise the standard, if

22 appropriate. And operationally, that is now in the form

23 of the ISA is essentially satisfying the requirement for a

24 criteria document, and the policy assessment -- well,

25 actually, if we reflect on this review process, it
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1 actually has been simplified in some ways, right?

2 MS. WEGMAN: Uh-huh.

3 DR. FREY: So we did not have a risk and

4 exposure assessment document to review and other review

5 cycles for this pollutant and other criteria pollutants

6 even -- like for ozone in the current review cycle, there

7 is a first and second draft of the REA that leads into a

8 first and -- you know, informs -- usually a first and

9 second draft of the policy assessment.

10 So in this case, we have not had an REA.

11 We also -- or it's been included in the policy assessment,

12 I think, is the more correct way to say it. So there has

13 been an REA, but it's folded into the policy assessment.

14 And we have basically a proposal from the EPA that we

15 review just one draft of the policy assessment. So -- and

16 that's another issue we should circle back to is just to

17 confirm if we're comfortable with having only reviewed one

18 draft.

19 I'm sure the agency would be delighted if

20 we are, and maybe we are. I -- since we also seem to be

21 supporting the policy recommendation of the agency, but

22 let's come back to that question in a few minutes.

23 So in some sense, you know, with the

24 current construct of this process, it has been streamlined

25 probably as much as it can be. And then some of it is,
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1 you know, honestly, as scientists and engineers, when we

2 get a nice document to review like a first draft ISA, we

3 all want to see it improved in our areas of specialty.

4 And then we get a revision, and second draft, maybe, it's

5 not quite there. Maybe there's new stuff that we see

6 that, oh, I didn't realize that. I want to review this,

7 and it could be better. And then it's a third draft, and

8 you know -- so you know, how much can we restrain

9 ourselves from asking for a third draft ISA?

10 And so that's also -- you know, honestly,

11 we interact with EPA in this process. So some of the

12 demand on EPA is in response to what we're asking for.

13 Yeah, Michael.

14 DR. KOSNETT: Yeah, but it ultimately has

15 tremendous benefit for the reasons that I said before.

16 DR. FREY: Oh, yeah, I'm not saying that it

17 doesn't.

18 DR. KOSNETT: And I agree -- you know, I

19 agree with Sean that let's take a multimedia, you know,

20 integrated approach. This ISA serves all the different

21 parts of EPA. I mean, it serves the water people, it

22 serves the Superfund people, it -- so it does -- you know,

23 we might say, well, the air component is shrinking, but

24 this whole process has a lot of impact.

25 And one other point I forgot to mention
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1 earlier that I think we don't -- we shouldn't lose sight

2 of it is the issue of margin of safety. You know, for

3 many of the things that EPA regulates, they set their

4 standards, you know, when they talk about a margin -- a

5 safety -- an order of magnitude, you know, they look for a

6 no L or a low L, and they set levels, you know, before

7 that, or they look for benchmark doses.

8 And if we look at the fact that for lead

9 the -- there's -- we're not talking orders -- an order of

10 magnitude margin of safety between the types of exposure

11 that are -- exist even under current regulations and

12 impacts on humans, which is not -- we're not talking about

13 cross-species extrapolation. We're talking about humans.

14 We're talking about margins of exposure where -- at the

15 regulations we're acknowledging that there may be some

16 effect.

17 So given the fact that lead is prominent in

18 the -- with respect to a very low margin of safety, if

19 any, for non-cancer effect. It assumes a distinction

20 that's not shared by many other chemicals.

21 DR. FREY: Yeah. Well, I think that opens

22 up some other issues that I don't know if we need or want

23 to get into a lot. But, you know, the statutory language

24 is that it needs to set a standard. I don't know, Lydia,

25 maybe I should let you quote it verbatim because you
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1 probably know this better than I do. But it needs to

2 protect the public health with an adequate margin of

3 safety.

4 MS. WEGMAN: Yeah, it has to be requisite

5 to protect public health with an adequate margin of

6 safety, that's right.

7 DR. FREY: Yeah. And those two phrases

8 "protect public health and adequate margin of safety," and

9 also in the context of judicial review of many of these

10 NAAQS doesn't necessarily imply that the standard must

11 have an order of magnitude of protection.

12 DR. KOSNETT: No, no.

13 DR. FREY: And it also doesn't imply that

14 the standard must protect every individual in the

15 population either.

16 DR. KOSNETT: No. And I'm glad you raise

17 that point. I'm not -- I think there was -- there were

18 aspects of the policy assessment, which indicated how the

19 assessment included some conservative assumptions.

20 DR. FREY: Right. So it's ultimately --

21 yeah.

22 DR. KOSNETT: And I'm not -- I wasn't

23 trying to open that whole issue of --

24 DR. FREY: Yeah, okay.

25 DR. KOSNETT: -- you know, that the
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1 standard wasn't meeting the margin of safety. That's not

2 what I meant, Chris. What I meant is that just in a more

3 general sense, when we compare lead to other substances,

4 we are dealing with very low level -- with effects at very

5 low levels of exposure that exist in our contemporary

6 environment.

7 DR. FREY: Right. Sure. Absolutely.

8 Yeah, you're right.

9 DR. KOSNETT: And that being the case, we

10 should be -- keep our eyes on the ball and say this is a

11 pollutant we need to look at because it's not like we've

12 set our exposures, you know, and regulated something that

13 -- you know, an order of magnitude or more like for a lot

14 of other substances way below it.

15 DR. FREY: Well, yeah. And actually, it's

16 -- it's actually not even necessarily unique to lead. So

17 this issue -- you know, the way the statute was written, I

18 don't know if I'm oversimplifying, but it almost seemed to

19 presume there would be thresholds below which there's no

20 adverse effect.

21 But operationally as well look -- get more

22 science on a lot of these pollutants, we're finding, well,

23 there are effects, and either we don't know if there's a

24 threshold, or there may not be a threshold. And the

25 statute maybe didn't envision that.
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1 DR. KOSNETT: Right.

2 DR. FREY: So -- anyway, that's kind of a

3 big discussion.

4 DR. KOSNETT: Yeah.

5 DR. FREY: But I guess Cliff has been

6 waiting patiently, so let me turn the mic to him.

7 DR. DAVIDSON: Just a quick comment, Chris.

8 Listening to what Dr. Kosnett was saying, Dr. Hays, I

9 think that when Lydia says that there's -- you've got

10 these words, if appropriate, it seems to me that there's a

11 little bit of wiggle room in here.

12 By the time this group, this panel, gets

13 involved in the process, the first ISA is already done,

14 and that's already a huge effort. I'm just wondering if

15 there's a way that a group such as this panel can have

16 some input into whether a full-fledged ISA is needed in

17 the future.

18 DR. FREY: Yeah, so --

19 MS. WEGMAN: If I could just --

20 DR. FREY: Go ahead, yeah.

21 MS. WEGMAN: I just wanted to note that, in

22 fact, thanks to the advice of prior CASACs, we actually

23 put in place a process for CASAC to be involved earlier.

24 There is what's called a kickoff workshop where we talk

25 with potential -- you know, people who are knowledgeable
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1 and also potential CASAC members about what the scope of

2 the review should be, what are the policy relevant

3 questions. And we take that, and we develop what's called

4 an integrated review plan.

5 And we do a draft integrated review plan,

6 which comes to the CASAC and to the committee. Now,

7 perhaps you weren't involved in it this time, but -- and

8 that draft integrated review plan lays out our strategy

9 for how we're going to move forward with the review. And

10 we see CASAC comment, and we revise based on CASACs

11 comments.

12 So there is an opportunity right in the

13 beginning both at the workshop and then the planning

14 process to give us your advice on what level of review is

15 needed.

16 DR. FREY: Yeah, and just to elaborate on

17 that, so as Lydia pointed out, the workshop is usually

18 open to the public. And we don't specifically have a

19 CASAC meeting at that workshop. And I think whether CASAC

20 members are there or not is either self-selection or --

21 it's not a formal CASAC event as a meeting like this is.

22 But the integrated review plan, you may

23 recall, we did review -- our first meeting as the lead

24 review panel was a teleconference to consult on the

25 integrated review plan. So it wasn't a review, but it was
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1 a consultation where we, you know, read the integrated

2 review plan. We offered comments and suggestions back to

3 EPA.

4 So yeah, there is that opportunity. And so

5 it may be that for the next review cycle we would just

6 want to -- whoever the people are -- it may be none of us,

7 or it may be most of us at that time -- encourage that

8 group to use that opportunity to weigh in on, you know,

9 how extensive does this next revision cycle need to be.

10 I -- but I also tend to think that just

11 sort of a group dynamic with scientists and engineers that

12 we're always going to ask for more rigorous science in the

13 ISA. So are we going to restrain ourselves from asking

14 for a third draft. And, you know, that may also be a fact

15 of life in the way -- just the human dynamics.

16 Yes, Rich and then Rich.

17 DR. CANFIELD: Yeah, I just want to stand

18 up in support of the third draft. I think a great deal

19 was accomplished. I mean, I just really -- a

20 transformation that turns this into a world class world

21 leading document. Maybe that only matters to scientists

22 and engineers, but I actually think that people look at

23 this document, they're going to learn about lead. And I

24 think it was worth the effort.

25 DR. FREY: Yeah, and I don't mean to imply
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1 anything to the contrary. And, you know, as -- my role in

2 this panel has been as a chair throughout, so I tend not

3 to weigh in too much on the substance. But on other

4 panels where I've been a panelist, as folks in the front

5 of the room know, I -- I mean, I've probably been

6 clamoring for third drafts as much as anybody else, so --

7 Rich.

8 MR. POIROT: Well, I was thinking in terms

9 of Sean's idea of this more of a holistic, multimedia

10 approach that wasn't that something that EPA kind of tried

11 about three or four cycles ago with the lead NAAQS review?

12 And I think probably Ian was there on the -- you've been

13 on all of them, haven't you?

14 But it's my understanding that, however,

15 this came following the whole nine yards of the process,

16 the criteria document and all its revisions, and the staff

17 paper and all it's revisions.

18 And then at the end, EPA said, well, in

19 lieu of lowering the NAAQS, we're going to go with this

20 multimedia approach, and here are our -- and it may not

21 have been -- maybe it was a good idea, but it didn't sit

22 well with the people that had put all the work into -- and

23 it's almost like we really did skip a cycle in the NAAQS

24 review --

25 MS. WEGMAN: Many cycles.
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1 MR. POIROT: -- and it probably would have

2 been lower than had not that approach been applied. I

3 don't know, but I guess the point that I would like to

4 make is that what would the goal might be would be can we

5 get to a place where we could review the NAAQS in the next

6 required cycle without needing to go the full approach, or

7 how do we shorten that.

8 And, you know, one kind of a question that

9 could be helpful would be to lead the ISA development with

10 the question of have there been any -- I forget Sean's

11 term -- eureka papers that have really changed the way

12 that we think about things because one of my kind of

13 general criticisms of the ISA is that maybe because now we

14 have this great hero tool, there's like a paragraph on

15 every new paper in there and -- regardless of its

16 relevance.

17 And at the end, you say something like, oh,

18 and this has greatly increased our understanding of -- I

19 don't know. No, it hasn't, you know. No, it hasn't.

20 It's just another new paper, and you could have put that

21 in an appendix, and you could have had a grad student

22 write the paragraph on each new paper. And that would be

23 a useful appendix all by itself.

24 But to lead -- to guide it with a -- have

25 there been new studies and in what areas that really
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1 recommend revision to the NAAQS would be a way to kick off

2 those workshops and to maybe put --

3 DR. FREY: Well, Rich, that's actually what

4 those workshops -- I mean, my understanding is that

5 actually is a goal of those workshops is to say what is

6 the new science since the last review? And I think that

7 maybe the disconnect is that we don't have the whole panel

8 either -- I don't know if it's a -- I don't remember if we

9 had the whole panel constituted. I think we may have, but

10 we certainly didn't have the whole panel present at that

11 workshop. And maybe that's something that would be

12 beneficial is to have the panel at the workshop.

13 Now, that's another day and a half or

14 two-day meeting, but that would provide more of an

15 opportunity for panel members to weigh in and also to see

16 what's going on, right?

17 Because another thing is -- I mean, these

18 panels are typically you guys are the expert in, you know,

19 the pollutant of interest, and so I think also, you know,

20 at least as a chair, I'm also relying on the panel to

21 weigh in early on in the ISA review process before the

22 deadline for literature is -- are there any studies that

23 have been overlooked?

24 So I think it's a two-way thing, right? We

25 want to see what the agency is proposing as key studies,
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1 but what do we know are the key studies? And the workshop

2 is a good chance to do that.

3 MS. WEGMAN: And Chris, I'll just point out

4 that all the panel members may well not have been at the

5 workshop. The purpose of the workshop is to actually

6 bring together a variety of experts to try to identify

7 what the issues are, where there might be new science, and

8 determine which expert -- which level of expertise we need

9 on the CASAC panel. And then the panel is form.

10 DR. FREY: Yeah, that's true. You're

11 right.

12 MS. WEGMAN: Yeah.

13 DR. FREY: So it's kind of before the

14 panel.

15 MS. WEGMAN: Yeah, so it's kind of a

16 kickoff for everything.

17 DR. FREY: Chicken and egg, yeah.

18 MS. WEGMAN: And then the IRP is where the

19 panel really gets to offer its advice.

20 DR. FREY: Yeah, that's right. I thank you

21 for clarifying that. So you should all look for these

22 workshops and attend and -- well, I guess we need to make

23 sure that these panelists are on the mailing list for the

24 next workshop.

25 MS. WEGMAN: Yes.
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1 DR. FREY: Yes, Rich.

2 DR. CANFIELD: Can those be --

3 DR. FREY: Well, I mean, the next lead

4 workshop, yeah.

5 DR. CANFIELD: Can those be webcasts?

6 MS. WEGMAN: You know, that's something we

7 can look into. We have been doing --

8 DR. FREY: Yeah, I'm sure.

9 DR. CANFIELD: I mean, that would be so

10 efficient for me.

11 MS. WEGMAN: Yeah, we're certainly starting

12 to use them more in all of our activities. So I suspect

13 that by the time we get to the next lead review, we will

14 certainly be capable of a number of things. Maybe we'll

15 even Skype with everybody. Who knows?

16 DR. FREY: Okay. So maybe just to

17 summarize what I think I heard, I -- so there's certainly

18 no consensus about a statement to the effect of phasing

19 out a lead NAAQS. I think I heard a lot of support, which

20 I think it's a good -- I think it's good to reflect on it

21 and say, you know, what's the value of what we've been

22 doing both as a panel and as a nation with lead. And so I

23 think we've heard a lot of good arguments in favor of the

24 NAAQS for lead.

25 And I'm not sure that this has to translate
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1 into any kind of statement unless -- one thought I had was

2 I think some of the ideas discussed might be useful to

3 fold into the policy assessment as far as the value of the

4 lead NAAQS, I think, as you deem appropriate. I don't

5 know if as a panel we want to make a statement. We could,

6 or we could just not say anything.

7 DR. KOSNETT: But I think it would be -- I

8 think there -- there's a consensus of the value of the ISA

9 to the agency, to the EPA, and to the broader

10 international -- you know, national and international

11 community given that it's a multimedia --

12 DR. FREY: Okay. So we could --

13 DR. KOSNETT: -- a multimedia pollutant

14 that we -- you know, is a major component.

15 DR. FREY: Yeah. So in the letter to the

16 administrator regarding the ISA, I think we could make

17 that point in the letter itself and just point out that

18 this is an excellent document and has value not just for

19 the NAAQS but well beyond that NAAQS, yeah.

20 DR. KOSNETT: Right.

21 DR. FREY: So I think that's a

22 noncontroversial statement. I don't think anyone will

23 disagree with that. Rich.

24 DR. CANFIELD: So one of the things -- and

25 again, this is speaking from a lot of ignorance about
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1 policy and government. I've been sort of surprised at how

2 restrictive the law is and how it seems unquestioned,

3 which is, can't we change laws? I mean, we're -- Okay.

4 (WHEREIN, unintelligible due to multiple

5 people speaking at once.)

6 DR. CANFIELD: So -- but the point that I

7 would make is, is there a way that EPA can make a

8 statement about what would be the most helpful formulation

9 of these laws so that they could take advantage of

10 efficiencies in -- you know, that are not available to

11 them because I'm thinking a seven-year review makes a lot

12 more sense than a five-year review or a -- you know.

13 DR. FREY: Yeah, if we could get congress

14 to narrow the scope to just change that, I agree with you.

15 DR. CANFIELD: Yeah. Oh, okay. I see.

16 DR. FREY: But it would open up the entire

17 Clean Air Act is the risk.

18 DR. CANFIELD: Right, okay. Well, the

19 other thing that goes into that, which may be related to

20 our feeling like nothing great has happened, you know, in

21 the last five years is that the funding for research that

22 could change our views is declining and has been declining

23 so that, you know, okay, there's no money to study lead,

24 but every five years, you have to review it. I mean,

25 there's a little bit of a catch-22 there.
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1 DR. FREY: Yeah. Well, that is the --

2 that's the general issue with the interface between

3 science and public policy is the public policy decisions

4 often are at a different time scale and different scope

5 than the science.

6 And so there's also language in the Clean

7 Air Act that it's at the administrator's discretion to set

8 the standard. So our role is really to advise the

9 administrator, but it at the administrator's discretion.

10 So that kind of bridges that gap. But, yeah, those are

11 good points.

12 Well, let me -- I think there's one more

13 practical decision we need to reach as a panel on -- are

14 we comfortable with having seen just a first draft of the

15 policy assessment and -- you know, clearly, we'll document

16 the advice to the agency with the understanding the agency

17 will make its best effort to incorporate our advice. Are

18 we comfortable that the next one will be the final

19 version?

20 DR. RABINOWITZ: Just an application on

21 that.

22 DR. FREY: Yeah.

23 DR. RABINOWITZ: I'm sorry. Before the

24 teleconference, will we get the revised draft of the

25 document?
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1 DR. FREY: No, no.

2 DR. RABINOWITZ: Okay.

3 DR. FREY: No. I was looking to see how

4 many jaws dropped in the front of the room when you asked

5 that because our teleconference is April 1st, and that's

6 only, what, less than two months from now.

7 MS. WEGMAN: Sorry. No, we can't do

8 that.

9 DR. RABINOWITZ: Okay. Thank you.

10 DR. FREY: So -- no, we will -- we would --

11 I think what EPA is proposing, the EPA staff is proposing,

12 this was the first review draft. They proposed this be

13 the only draft reviewed by CASAC. They would like to go

14 to a final version. And then from there, they would

15 proceed with whatever rulemaking would come from that

16 process.

17 Of course, the administrator would receive

18 our advice through the letters both on the ISA and the

19 policy assessment, and that's where EPA would propose we

20 kind of wrap up CASAC's role on this review cycle.

21 DR. RABINOWITZ: Help me understand then.

22 So what would be the purpose or the agenda of that

23 teleconference?

24 DR. FREY: Well, that teleconference is --

25 we as CASAC have to prepare the final responses to the
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1 charge questions that, you know, each of you have been

2 assigned or many of you are lead discussants on and also

3 the letter from CASAC to the administrator.

4 So the letter plus our response to the

5 charge questions, and then we append to that all of the

6 individual member comments constitutes the CASAC report to

7 the administrator. So we report directly to the

8 administrator. That conveys our advice on the ISA and on

9 the policy assessment.

10 And we'll do that in two separate reports.

11 So we'll have a report on the ISA, we'll have one on the

12 policy assessment. So the purpose of the April 1st

13 teleconferences is, as a panel, we will receive about,

14 what, three or four weeks before that a draft of the

15 letters, and a draft of the response to charge questions,

16 and also the final individual members comments.

17 You would review that. And in the

18 teleconference, we can have discussion of any remaining

19 issues that need to be discussed. After which those

20 reports will become final and delivered to the

21 administrator.

22 Well, I should say there's another step

23 after that which is that the seven-member CASAC, the

24 chartered CASAC will review the report. We call that a

25 quality review, and usually that's just to clarify issues.
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1 It usually doesn't substantively alter the reports.

2 MS. WEGMAN: And I did just want to say,

3 again, that if, for whatever reason, this panel wanted to

4 comment on the final policy assessment, while we won't be

5 soliciting your advice, the panel certainly can always

6 offer us comments if they choose to.

7 DR. FREY: That's right, yeah. So if the

8 policy assessment comes out, and you know, there seems to

9 be a lot of interest in providing more comment, we can do

10 that maybe through a teleconference meeting, most likely.

11 DR. RABINOWITZ: But we'll get a copy of

12 that to look at at some point?

13 DR. FREY: Yeah. Oh, yeah. Everything

14 related to this review cycle you will get from the DFO.

15 You will get -- so when the final policy assessment comes

16 out, that will -- we will know about that.

17 So I guess let me just -- I want to reach

18 closure on this issue of -- let me say it this way that my

19 interpretation of the discussion is that the lead review

20 panel is consenting or agreeing that the next version of

21 the PA would be essentially the final draft. We would not

22 be asking for a second review draft. Is there any

23 disagreement with that?

24 (No response.)

25 DR. FREY: Okay. So I think to summarize
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1 our bottom line advice to the administrator on the policy

2 assessment, it basically will be that we concur with EPA

3 staff on the recommendation on both the primary and

4 secondary standards, and that's kind of our key advice to

5 the administrator.

6 And I think we've already agreed to that,

7 so I think that covers the scope of what we really need to

8 address. Are there other issues whether it's from the

9 DFO, or whether it's from members of the panel, or from

10 EPA that -- anything we've missed?

11 DR. YEOW: I just wanted to clarify that,

12 you know, we did have the clarifying comments from the

13 public. We did not receive any requests to provide any

14 clarifying comments on the PA.

15 DR. FREY: Okay. Anything anyone wants to

16 say? I -- oh, I'm sorry, Rich.

17 MR. POIROT: Well, this kind of relates

18 back to our discussion on the ISA being this useful world

19 class document and so on and so forth, which I agree with.

20 But there was a point in time in the past when a decision

21 was made to transition a criteria document from being all

22 about lead, the state of the science for lead, to being

23 only what's new about lead.

24 And that was intended to be, you know, a

25 shortening process so that the things would be less thick,
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1 but it didn't really work. In fact, they got thicker, you

2 know.

3 DR. FREY: And how do you know how thick it

4 would have been?

5 MR. POIROT: Well, I have an old copy of

6 the original PM criteria document that's this thick, and

7 it was really good too. And it hasn't changed that much

8 since those days, but I guess the -- what I was going to

9 say is that you read these ISAs or whatever, and you know,

10 it's an awkward thing to write because you've kind of got

11 to say here's what's new, but you can't really say it

12 without saying but here's what we used to think and then

13 either reference the previous version of it.

14 And so you're always in this sort of cycle

15 of referencing the -- so I don't know. I keep thinking

16 what if, in fact, you did have this be a standing document

17 of the state of the science of our understanding of lead

18 that wasn't trying to just play catch-up because of the

19 awkwardness in that, and because it's not comprehensive

20 and because actually most of what we know about lead is

21 what we used to know about it.

22 So what if it were back to this more

23 intentionally comprehensive thing where you had broad

24 statements that could be supported by many references

25 rather than a paragraph on each new paper that's pretty
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1 much not really very relevant. And then we could just see

2 the changes that were necessary in each review cycle.

3 What is it that's really made us need to change our state

4 of the understanding and have those redlined, and that

5 would be really informative. Then we'd really know what's

6 moved things in a different way.

7 It would be a lot of work for EPA staff to

8 do that the first time. But after that, maybe it would

9 become much easier. I don't know, just a thought.

10 DR. FREY: Yeah, I mean, this comes up in

11 every criteria pollutant review. I think we've had the

12 same discussion in the ozone panel, the PM panel, the CO

13 panel. So yeah, it is a common theme, and I think we're

14 kind of figuring this out as we go. I mean, on both the

15 agency and CASAC.

16 I think one model that -- I think this was

17 discussed maybe more in the ozone panel is to try to

18 summarize the previous state of knowledge and then

19 explicitly discuss what's been changed but not to

20 incorporate within the current ISA everything that was in

21 the previous criteria documents or the previous ISA for

22 those pollutants that have now gone through kind of this

23 more modern cycle already.

24 And actually, the group to talk to about

25 that is the group that was here yesterday, NCEA, because
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1 OAQPS is involved with the REA and the policy assessment,

2 but NCEA is responsible for the ISA.

3 Yeah, I -- maybe the general comment is

4 just to look for opportunities to take a common approach

5 across criteria pollutants and kind of settle in on a way

6 of handling that.

7 I think we may actually be getting close to

8 that because I think the panels, individual panels, tend

9 to give the same kind of comments. And so NCEA has heard

10 that in multiple pollutant contexts of ozone, PM, lead,

11 and so on.

12 So I think it's a good point, and it's a

13 general point. I'm not sure operationally what to do with

14 that right at the moment, but you know, I think it may be

15 worth some kind of -- maybe it's worth an administrative

16 discussion with NCEA as far as how they would like to

17 format these documents in the future, and maybe we have

18 enough experience to settle in on a consistent approach by

19 now.

20 Any other comments?

21 (No response.)

22 DR. FREY: I did want to -- as far as the

23 schedule going forward, we have a deadline of February

24 20th to receive the -- you know, the -- essentially the

25 final draft response to charge questions from each of the
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1 discussant groups.

2 So if you could use the time between now

3 and that deadline to iterate within your group, and also

4 if you, as a panel member, had material you wanted one of

5 those groups to consider, you know, please send it to the

6 group leader. I'm sure everyone did their best to take

7 notes, but it's real easy to miss something. And if you

8 want to make sure that your point is considered, make sure

9 to e-mail the group member.

10 But just remember the FACA rules for

11 communication outside of these public meetings. It is

12 okay to exchange information among a limited number of

13 panelists, but you must copy Aaron Yeow who is the DFO.

14 That's an essential requirement. I would be happy if you

15 copy me also, but you must copy Aaron. That's kind of a

16 legal requirement.

17 Do not send e-mails to large numbers of the

18 panel. Like don't send an e-mail to the whole panel.

19 That would be considered deliberation. So, you know, if

20 you're sending an e-mail to three or four people, that's

21 generally okay. Yes, Ian.

22 DR. VON LINDERN: You gave me an assignment

23 to come up with a few sentences.

24 DR. FREY: Yes.

25 DR. VON LINDERN: Do I have a group?
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1 DR. FREY: Yes. Your group is the panel.

2 Would you like to make a comment about what you would like

3 to get from the panel?

4 DR. VON LINDERN: Well, I don't want to

5 hold things up any more, but I wondered who -- how I could

6 share that in advance of the --

7 DR. FREY: Why don't you share that with me

8 and Aaron, and maybe -- so this pertains to the issue of

9 looking at kind of the -- sort of the adverse effects of a

10 U.S. based approach and commenting on that.

11 So are there any members of the panel that

12 would particularly like to provide Ian with some input or

13 review his drafts? Do we have any volunteers? So --

14 Michael?

15 DR. KOSNETT: I'll look at it, and I have a

16 colleague who has participated in some of the U.S.

17 commerce department and state department issues about

18 export of lead. And I know he has a lot of reports and

19 stuff, so I can help Ian get those.

20 DR. FREY: Okay. Well, I don't know,

21 Aaron, if you want to comment on that?

22 DR. YEOW: Yeah, just, you know, you're not

23 supposed to be consulting with outside for that in that

24 respect, but if you have additional literature to share

25 with Ian, then that would have to be made public to
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1 everybody. So you would have to submit that kind of like

2 a public comment or something like that so that the public

3 would have access to that -- to those references that you

4 provided to him.

5 DR. KOSNETT: Okay. I'll give them to you

6 then. I'll give them to you, and you can give them -- but

7 you know, there have been some recent meetings between the

8 U.S. -- between U.S. government and representatives, let's

9 say, in Mexico about lead batteries and recycling.

10 DR. FREY: Okay. Sure.

11 DR. KOSNETT: And that could probably

12 inform what Ian's doing. I know -- you know about these,

13 Ian, but you know, I'm willing to help out.

14 DR. FREY: All right. Well, I think the

15 key thing is, Ian -- and Michael can support you, and if

16 anyone else wants to volunteer. But I think Ian -- I'm

17 confident that the two of you -- yeah, go ahead.

18 DR. YEOW: So that once Ian develops that,

19 that will make its way into the final reports that -- I

20 mean, not final, but the draft reports that the entire

21 panel will then subsequently be able to have an

22 opportunity to review prior to the teleconference.

23 DR. VON LINDERN: So I give them to you,

24 and they'll go out to everybody?

25 DR. FREY: Yes.
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1 DR. VON LINDERN: Okay.

2 DR. FREY: So that will be due by February

3 20th. So we'll -- Aaron will collate, and Aaron and I

4 will review and do editorial revisions just to make the

5 thing stylistically consistent and also to draft the

6 letters to the administrator on both the ISA and the

7 policy assessment. You'll get that. It should be the

8 week of March 11th.

9 And then on April 1st, we had previously

10 scheduled a teleconference. Hopefully, it's in your

11 calendar from -- on Monday, April 1st from 1:00 p.m. to

12 4:00 p.m. So at that teleconference, we'll review the

13 letters and the response to charge questions.

14 DR. KOSNETT: April 1st?

15 DR. FREY: April 1st, and that has no other

16 significance.

17 DR. CANFIELD: 1:00 to 4:00, you said?

18 DR. FREY: 1:00 to 4:00, Eastern Time,

19 yeah. I think we've conducted all of our business.

20 Anything we've missed? I would like to thank the agency

21 for, you know, this process that we've been through and

22 the development of the policy assessment. And I think the

23 feedback you're getting is validation of what you brought

24 to us is appropriate. And so I think that is a measure of

25 success for your endeavors. And so we really appreciate
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1 all the effort of the EPA staff, both in NCEA and in

2 OAQPS, to inform our ability to review and provide advice

3 to you as a staff and also our advice to the

4 administrator. So I greatly appreciate --

5 MS. WEGMAN: And if I could just add my

6 thanks to the entire panel for all the work you've done,

7 speaking for both NCEA and for OAQPS for the agency. We

8 are very appreciative of all the time you've taken to

9 review these documents and provide very thoughtful and

10 helpful comments on them over multiple drafts of the ISA.

11 So thank you very, very much for all your

12 help and service to the agency.

13 DR. FREY: Oh, thank you. Yeah, and I'd

14 like to thank Aaron as the DFO and the SAB office for

15 their support of CASAC, and they do a lot of

16 administrative stuff to make these meetings possible. And

17 so a lot of work goes on behind the scenes. Aaron and the

18 SAB staff work incredibly hard to make this process as

19 effective and possible as it is.

20 And I would like to thank all of you,

21 members of the panel, for your dedication. I think this

22 has been, you know, a very collegial panel, and I've

23 really enjoyed working with each of you on this. And I

24 think the depth of expertise and the exchanges we've had

25 have been really high-level, and I've learned a lot.
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1 So I just -- I really appreciate the

2 contributions you've made, and this is a true service to

3 the nation. So I think this is kind of a high level of

4 public service that we're privileged to do as scientists

5 and engineers, so thank you very much.

6 And I think with that, I'm going to turn it

7 over to the DFO. I think the DFO officially adjourns the

8 meeting, so --

9 DR. YEOW: So I would just like to echo

10 Chris in thanking EPA for bringing these documents forward

11 and being responsive to the comments of the panel. Thank

12 you to the panel for all your hard work in reviewing all

13 these documents. And thank you, Chris, for chairing the

14 panel and leading us through efficiently and finishing the

15 business at hand. So with that, we can be adjourned.

16 Thank you.

17 (WHEREIN, meeting was adjourned at

18 11:36 a.m.)

19

20

21

22

23

24

25
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1 C E R T I F I C A T E

2

STATE OF MISSOURI )

3 ) ss.

COUNTY OF JEFFERSON )

4

5 I, Wanda L. Greenlee, a Certified Court Reporter,

6 CCR No. 1188, within and for the State of Missouri, do

7 hereby certify that the tape transcription in the

8 foregoing tape was transcribed to the best of my ability

9 and therefore reduced to typewriting under my direction;

10 that I am neither counsel for, related to, nor employed by

11 any of the parties to the action in which this tape was

12 taken, and further, that I am not a relative or employee

13 of any attorney or counsel employed by the parties

14 thereto, nor financially or otherwise interested in the

15 outcome of the action.

16

17

18 ______________________________

 Wanda L. Greenlee, CCR

19

20

21

22

23

24

25
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A

a.m 2:1 125:18

Aaron 2:14,25

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abatement 48:20

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ability 9:23 17:21

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able 27:6,20 35:22

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absolutely 31:8

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academia 3:25

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accomplished

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acidification 10:2

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acknowledged

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59:22 86:16 124:5

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addressing 85:13

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100:2,5,8

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ADHD 60:21

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125:17

adjourns 125:7

adjusted 59:19

administrative

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administrator 3:10

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83:16 110:16

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advice 18:19 24:20

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advise 3:10 82:6,16

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aerial 31:12

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age 57:21 60:1,4,14

61:23 65:23,24

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75:10 76:19,21

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88:4 89:19 93:1,1

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air-to-blood 77:14

airborne 18:5

50:23 94:12

airport 45:14

Allen 3:22 13:13,14

18:22 19:24 23:11

23:12 29:25 31:8

32:8,15 33:10,14

34:4,13,18 35:12

36:1,6 37:8 38:4,7

38:23 39:2,22

40:4 41:12 68:12

68:24 69:16 70:8

70:12 82:25 83:2

allow 30:11

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82:16

alternatives 67:11

69:13

Alzheimer's 72:20

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10:20 17:15 73:8

73:13,16,20 86:8

89:19,21

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Amendment 85:5

American 71:18

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14:24 15:3 16:22

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amount 4:12 10:22

28:2 44:4,18,23

45:2 67:17,24

88:10

analyses 9:12 77:9

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analysis 9:3 36:3

angle 40:16

animal 72:23 81:6

animals 16:18

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40:6 41:18 65:18

66:8 77:3 83:3

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answers 19:2 23:5

86:14

anticipate 40:25

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apply 20:21 26:15

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apportionment

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approach 20:11,20

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32:18 33:7,11

36:2 37:4,21 38:9

38:17 39:10 49:13

78:10 80:11 92:6

92:21 93:10,25

98:20 105:10,20

106:2,6 119:4,18

121:10

approaches 32:5

66:25

appropriate 6:1,5

19:13,20,22 20:3

20:9 21:8 24:15

29:20 39:16 42:18

45:20 50:16 69:12

82:19 89:6 93:11

95:5,7,10,15

96:22 102:10

110:4 123:24

appropriately 4:7

5:18 33:8 91:15

appropriateness

73:24

approximately

44:6

April 113:5 114:12

123:9,11,14,15

aquatic 6:20 10:1

28:3,4

area 25:20 46:1,25

47:9 65:2,16,17

65:18 67:13 71:12

73:14

areas 58:23 71:25

73:7,16 91:3 98:3

106:25

argue 86:9,10

argument 85:16

arguments 91:17

109:23

arsenic 87:15

asked 113:4

asking 45:8,12 98:9

98:12 104:13

115:22

asks 5:13

aspect 9:4 40:17

aspects 4:8 15:20

83:17 95:24

100:18

assess 15:10

assessed 4:8

assessment 2:9 3:7

5:16 8:6 19:6,9

23:23 24:13,24

31:15 34:12 42:23

43:9 58:11 71:24

74:20 75:3 76:18

78:5 81:14 86:24

87:7 93:17,21

94:6 96:5,24 97:4

97:9,11,13,15

100:18,19 110:3

112:15 113:19

114:9,12 115:4,8

115:15 116:2

119:1 123:7,22

assessments 14:1

19:10 58:11

assigned 68:14

114:2

assignment 120:22

associate 21:9

associated 19:14

69:18 86:23

association 56:11

80:6

assume 6:16 64:13

assumes 86:3 99:19

assuming 59:17

assumptions 6:8

100:19

atmospheric 16:5

ATSDR's 87:13

attacks 33:15

attainment 87:1

attend 108:22

attended 16:20

attention 34:3 53:1

60:21 73:11

attorney 126:13

authors 26:14,15

availability 46:11

available 5:19 9:2

11:7 12:15 19:9

26:21 28:3 46:16

47:8 51:14 55:21

55:22 111:10

average 48:5

averages 49:6

averaging 20:2

aviation 84:18

aware 95:24

awful 69:3

awkward 53:8

117:10

awkwardness

117:19

B

baby 59:14

back 2:5,20 19:17

20:23 21:3 26:19

37:22 43:9 45:22

46:21 53:15,23

54:21 63:14 65:6

69:20 71:17 82:20

97:16,22 104:2

116:18 117:22

background 38:11

38:12

bacon 81:3

bald 14:20

ball 101:10

base 15:23

based 15:8 19:9

23:8 77:20 87:14

103:10 121:10

basic 6:8 28:15

29:21 71:4

basically 8:6,18

13:4,15 21:7

35:17 84:22 97:14

116:2

basing 22:4,4

basis 92:22

batteries 67:18,24

67:24 68:25 69:13

69:20,24 70:3,10

122:9

battery 69:2

beginning 12:7

103:13

behavior 60:21,23

62:7 72:23 80:19

81:7

behavioral 58:3,4

61:15

behaviors 60:3

71:19

believe 15:3 29:11

belongs 53:4,5

benchmark 99:7

beneficial 107:12

benefit 15:18 73:6

98:15

benefiting 50:21

benefits 21:13,14

benign 59:13

benzene 86:12

best 3:2 75:6

112:17 120:6

126:8

better 5:23 9:17

10:24 12:2 33:9

38:10,19 47:7

48:14 51:13 69:8

71:11 72:15 75:10

75:11,13 86:3

93:7 98:7 100:1

beyond 17:24 27:4

42:20 51:3 86:5

87:8 88:4 110:19

big 16:9 24:3 42:5

42:10 57:12,13

63:7 90:15 96:13

102:3

bigger 42:12

biggest 41:12

bio 32:1

bioavailability

31:19 34:7,8 39:1

41:14,23 90:19

bioavailable 28:16

55:10

biokinetics 65:19

65:21

biological 32:1

47:17

biology 34:16 79:3

biomarkers 63:19

65:11

biota 15:20

bird 17:7

birds 15:20,25

bit 4:18 6:2 7:25

17:21 20:24 32:25

47:6 68:21 82:24

94:7 96:19 102:11

111:25

blah 52:23,23,23

blood 54:2,6,13

55:17 56:5,6,13

56:21 57:1 63:25

72:5 73:6,9 75:11

76:15,18,19,23

77:13,19 89:10

blunder 58:15

body 44:10

bomb 90:20

book 16:21

bottled 6:16

bottom 18:18 54:4

82:13 116:1

bound 42:8

box 79:11

boy 38:15

brain 58:14
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break 19:3

breast 56:8

bridges 112:10

brief 70:24

briefly 43:12

bring 53:1 80:16

108:6

bringing 36:11

91:25 125:10

brings 62:7

broad 17:21 117:23

broader 54:17 58:5

74:23,24 87:6

110:9

broadly 39:11 51:7

Brook 6:19,25 7:13

7:14

brought 88:14

123:23

Brown 66:9

build 69:4

bullet 33:5 72:21

72:25 73:5,12,18

78:14

bullets 72:3 76:14

bus 58:15

business 82:12

123:19 125:15

C

C 126:1,1

calendar 123:11

calibrate 8:3

calibrated 65:23

California 14:20

67:9

call 12:16,20 36:16

58:24 73:10

114:24

called 102:24 103:3

Canfield 48:1,3

56:1 57:8 60:13

60:20,24 61:2,7

61:11,25 62:4

80:14 84:1,6

88:18 104:17

109:2,5,9 110:24

111:6,15,18

123:17

CANTAB 58:9

capable 109:14

captured 90:12

captures 4:7

carbon 42:2,2,4,4

carcasses 16:17

cardiovascular

63:7,19 64:1,3,9

care 41:18 51:8

84:3

carefully 69:22

CAROLINA 1:12

CARY 1:12

CASAC 1:9 3:9

24:20,23 82:6

83:12 95:16

102:23 103:1,6,10

103:19,19,21

108:9 113:13,25

114:3,6,23,24

118:15 124:15

CASAC's 113:20

CASACs 102:22

103:10

case 6:13,14,22,25

7:10,12,14,23,23

7:24 8:24 11:16

12:25 77:21 79:24

80:7 97:10 101:9

cases 7:2 8:17 9:10

cataclysmic 59:4

catastrophic 55:7

catch 36:25

catch-22 111:25

catch-up 117:18

categories 15:8

84:25

categorizing 88:8

category 45:21

88:25

caught 85:23

causal 22:19

causally-related

60:19

causation 65:7,16

cause 36:17 41:8

causing 7:8

CCR 1:21,22 126:6

126:18

CDC 56:2

cell 67:18

cellular 67:22

Center 56:24

certain 15:19 30:10

44:17,17 63:5

76:15

certainly 7:15 13:6

17:12 20:11,21

22:20 24:20 28:25

46:22 52:14 58:13

59:12 69:3,4

74:23 88:14 95:8

107:10 109:11,14

109:17 115:5

Certified 126:5

certify 126:7

cetera 9:12 48:20

chair 52:24 105:2

107:20

chairing 125:13

chance 53:10 76:7

108:2

change 6:7 11:21

20:5 21:25 41:1,5

41:21 42:3,3,10

46:18 56:12 70:11

90:19 111:3,14,22

118:3

changed 11:18

24:17 89:1 106:11

117:7 118:19

changes 21:12 41:6

41:13,13,21 56:14

59:17 118:2

changing 16:11

19:16 21:19 42:13

71:18 90:16 91:8

chapter 2:8 3:15,18

3:21 4:6,7,11,11

18:14,17,25,25

19:20 21:13 22:10

23:15,16,17,19

24:9 25:19 34:23

39:15 42:20 43:3

43:23 47:22 50:15

53:19 68:16,16,20

71:24 73:24 75:1

chapters 2:10 3:7

42:22 47:24 50:11

characteristics 9:9

47:6

characterize 8:1

characterized 5:17

13:5

characterizes 4:8

characterizing

48:13

charade 8:24

charge 2:17,21 4:5

5:13 19:1,4,18

20:17,18 42:19

43:14 53:24 54:19

69:6 74:9 114:1,5

114:15 119:25

123:13

charged 10:5,6

67:23

chart 15:5,7 45:23

chartered 114:24

check 86:20

chemical 30:14

47:15 90:23

chemicals 99:20

chemist 68:6

chemistry 34:15

67:10 68:7 70:14

Chicken 108:17

child 48:18 61:12

61:15 65:22

children 48:5,23

55:11,23 56:13

57:19 63:3,4

65:24 66:2,4 72:7

72:12,16,17,17

73:6

children's 54:1

55:17

chime 75:17

chloride 41:18

choose 83:22 115:6

Chris 3:21,24

13:21 17:20 19:11

20:25 25:18,23

32:22 39:22 41:11

43:3 44:1 52:2

87:4 95:4,13

101:2 102:7 108:3

125:10,13

Chris's 24:18

Christi 6:18

circle 2:5,20 43:9

53:14 97:16

circuitry 59:15

circumstances

72:11 77:20

citing 19:11 21:8

clamoring 105:6

clarification 3:3

clarify 49:8 114:25

116:11

clarifying 2:11,12

108:21 116:12,14

class 104:20 116:19

classroom 30:3

clean 1:8 46:15

85:4 111:17 112:6

clear 46:13 48:23

59:13 75:24 96:6

clearly 17:9 23:14

54:9 63:6 69:18

72:9,19 87:10

112:15

Cliff 43:20,21 45:3

48:4 55:1 62:19

90:14 102:5

climate 41:1,4,21

42:3,3,10,13

46:17

clinicians 79:13

close 81:24 119:7

closer 72:6

closure 115:18

co-stressors 41:2

coarse 47:11,16

cognitive 58:3,4

cohorts 64:2 73:3

collapsed 77:12

collate 123:3

colleague 121:16

colleagues 4:10

13:11

collect 23:25

collecting 57:1 88:3
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collects 47:12

collegial 124:22

column 30:19

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comes 5:9 40:24

77:24 103:6 115:8

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comfortable 39:6

81:25 97:17

112:14,18

coming 39:7 85:19

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comment 10:25

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70:24 80:2 102:7

103:10 115:4,9

119:3 121:2,21

122:2

commenting 39:7

121:10

comments 2:11,13

13:9 18:13 23:6

23:12,17 25:21

35:5 36:20 39:15

39:18 47:1 52:16

53:6 62:13 82:9

86:17 94:14

103:11 104:2

114:6,16 115:6

116:12,14 119:9

119:20 124:10

125:11

commerce 70:11

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121:17

commitment 56:15

57:20

committee 1:9

52:10 92:16 103:6

common 72:6

86:11 118:13

119:4

communicated

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communication

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community 23:25

110:11

compare 101:3

compartments

28:19

complaints 60:25

completely 69:1

90:5

complex 3:3

complexation

30:20

complicated 28:14

59:20 80:1

compliment 70:25

component 15:23

41:9,10 54:8 91:9

98:23 110:14

components 95:25

compounds 94:3

comprehensive

117:19,23

computerized

58:11

concentration

31:25 54:6,14

77:15 89:21

concentrations 7:4

7:5,6,14,24 8:20

21:12 29:5 36:22

44:10 54:2 73:16

77:19 89:13,19

concept 70:13

concern 14:19

44:15 57:16 63:7

76:1 87:11,19,20

91:24 92:7 93:13

concerned 52:9

concerning 64:7

concerns 12:4

13:10 14:23 70:20

82:2 88:5

conclusion 4:2,15

7:4 12:18

conclusions 6:5

19:5,22 23:15

82:7

concordance 24:14

concretely 57:20

concur 65:8 116:2

condition 64:16

condor 14:20

conduct 61:15 81:7

conducted 30:13

123:19

confessed 79:18

confidence 23:10

confident 43:19

122:17

confirm 97:17

confounding 22:3

confront 55:5

congress 111:13

connect 31:23 42:9

42:10

consensus 2:21

43:14 45:6 52:3

82:22,23 83:2,4,9

90:14 109:18

110:8

consenting 115:20

consequence 45:17

45:19

consequences

58:25 59:7 70:16

conservative

100:19

consider 5:7 9:5

27:6 36:13 45:17

51:4,24 57:25

67:2,17 73:24

74:7 89:7 91:8

120:5

considerable 87:10

87:19

consideration

15:21 17:16 67:13

considered 13:6

21:1 22:22 25:22

52:16 59:10 120:8

120:19

considering 18:1,5

82:16

consistent 23:5

61:18 119:18

123:5

consistently 47:18

constituted 107:9

constitutes 63:1

114:6

construct 61:15

97:24

consult 103:24

consultation 104:1

consulting 121:23

contact 2:13

contaminant 37:17

contaminants

38:10,19 47:15,17

contaminated

38:16

contemporaneou...

57:3

contemporary

87:12 101:5

context 20:4 58:7

75:3 100:9

contexts 119:10

continue 42:6

90:24,25,25

continued 85:17

continues 11:22

continuing 14:16

50:22

contrary 105:1

contribute 71:7

contributed 56:22

contributes 47:4

65:1

contribution 43:1

54:15 63:3 64:8

64:20 66:19

contributions

20:12 125:2

control 30:17

controlled 8:14

89:5 91:16

controlling 92:1

controls 45:9 89:1

controversial 53:17

convenes 2:1

conversation 60:2

conveys 114:8

copied 2:25

copy 115:11 117:5

120:13,15,15

Corpus 6:17

correct 8:3 65:24

97:12

correctly 6:14 7:22

29:10 36:12

cortiles 63:10

CORY-SLECHTA

53:22

cost 86:23

counsel 126:10,13

counties 48:10

countries 67:19

country 45:19

55:18 71:20

county 48:8 126:3

couple 4:16,16 8:4

13:16 19:17 26:20

51:7,7 54:25

88:21 89:20,21

94:14

course 8:9 9:8 27:3

33:20 39:12 46:5

85:13 86:4 113:17

Court 1:21 126:5

cover 35:20,21

coverage 28:10

covered 46:15

51:11

covers 35:17 80:15

116:7

crap 94:9

create 76:22

creative 80:10

criteria 9:7 38:3

40:19 86:10 89:12

94:20 95:6,11,15

96:21,24 97:5

105:16 116:21

117:6 118:11,21

119:5

critical 8:10 9:1,3

9:24 11:5 15:14

15:15,16 16:8

20:20 23:23 26:3

26:6,12,21 27:3,5

27:9,15 28:5,7
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cross-sectional

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cross-species 99:13

crux 39:18

culture 22:16 71:20

curious 48:19

current 4:21 5:7

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currently 5:19

12:15 23:8 42:8

44:4 45:10 54:3

70:21 71:4

cut 71:9

cycle 3:11 51:3,4,5

89:17 92:17 96:15

97:6 104:5,9

105:23 106:6

113:20 115:14

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cycles 97:5 105:11

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D

data 8:1,23 9:13

10:2,10,12,15

13:8 14:2 19:12

21:4,8,17,25 22:5

22:13,22 23:25

25:20 26:10,16

27:9,13 28:2

35:10 45:14,14

49:19 50:4 57:5

63:9 79:11

database 11:8 13:9

daunting 35:15

DAVIDSON 44:1

102:7

day 43:18 107:13

days 117:8

de-list 93:24

deadline 107:22

119:23 120:3

deal 3:3 9:9 33:22

104:18

dealing 38:19

66:25 92:24,24

101:4

deals 33:15,16,16

35:13 42:19

dealt 32:10

death 63:15

Debbie 48:7 64:21

67:8 70:25

Debbie's 80:20

Deborah 3:14

43:21 53:19 56:19

57:8 68:17

decades 55:15

decided 75:15

decision 5:21 11:25

12:12,13 13:1

21:6 22:6 23:1

74:21 112:13

116:20

decisions 15:22

36:8,9 112:3

declare 50:19

declining 10:22

111:22,22

decomposition

42:7

decreases 54:14

decreasing 68:1

dedication 124:21

deem 110:4

deemed 6:1 7:11,13

default 11:20

defer 47:24 57:8

define 79:6

degree 23:10 94:1

Deirdre 77:3

deleted 24:16

deliberation

120:19

delighted 97:19

delivered 114:20

delivery 58:9

demand 98:12

demography 71:18

denominator 14:3

density 69:7

department 121:17

121:17

departments 48:8

49:16

depends 61:7,11

74:13 77:4

deposited 46:5,7,12

46:23

deposition 10:1

16:5 31:12 37:25

38:1

depression 60:17

depth 124:24

describe 31:11,18

84:7,9

describes 32:10

describing 20:1,22

descriptive 29:25

30:23 32:11,20

design 80:7

designated 2:13

designation 87:1

designed 30:12

desirable 47:20

desire 91:19

detailed 62:10

details 46:4 69:11

69:21 72:2

determine 8:11

108:8

detrimental 73:1

develop 9:23 22:1

36:2,6 70:15

103:3

developed 33:8

74:21

developing 28:5

45:6 90:14

development 10:4

22:22 50:2 62:4

106:9 123:22

developmental

56:14

develops 122:18

deviations 78:1

devoid 30:5

DFO 115:14 116:9

120:13 124:14

125:7,7

diet 62:23

difference 34:16

40:12

differences 79:17

different 10:16

11:6 12:13 13:1

16:13 20:13 23:4

28:8,11,19 34:21

35:10 36:14 37:19

37:20,21 39:25

47:5,8,24 62:2

74:12,16 77:20,25

90:4 98:20 112:4

112:4 118:6

difficult 4:20,24

18:8 26:22,23

43:17 44:21 56:10

difficulties 57:18

difficulty 44:9

Diffusion 30:15

direct 84:19

direction 11:6

31:18 32:24 50:7

126:9

directly 21:13

33:12,14,15 37:3

114:7

disagree 16:2 32:2

110:23

disagreement

115:23

DiSC 58:8

discomfort 54:3

disconnect 107:7

discrepancy 52:25

discretion 83:22

112:7,9

discuss 2:9 3:16,18

13:22 84:12

118:19

discussant 3:22

18:21 120:1

discussants 2:23

3:23 18:22 43:12

114:2

discussed 13:24

18:25 19:11,24

35:24 53:2,4

81:17 110:2

114:19 118:17

discussing 2:17

53:24 84:11

discussion 2:8 3:2

4:19 12:10 13:23

14:17 15:17,18

19:20 21:18 22:9

24:7 42:22 43:15

43:18 44:2 47:25

50:16,19 51:2

53:10,14,24 54:8

54:10,17 62:9

72:7 74:1,4 75:9

78:23 80:14 82:4

82:13,20 93:11

102:3 114:18

115:19 116:18

118:12 119:16

discussions 11:1

19:3 37:24 83:21

disease 50:24 79:24

diseases 79:25

dispersed 51:8

dispute 65:17

dissolve 41:20

distinct 12:23

distinction 47:2

72:18 99:19

distressing 22:3

distribute 91:1

distribution 42:4

44:15 91:5

disturbing 46:23

doable 55:11 57:14

58:7

document 6:6 13:6

16:3 19:10,11

26:1 62:17 65:20

72:19 73:23 76:17

94:20 96:24 97:4
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doing 3:1 26:17

37:2,4 48:20 66:5

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domain 80:18 81:5

86:6

dominant 89:5

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dose 48:24 64:10

64:11 75:25 76:4

doses 99:7

Dr 2:2 3:14,20,23

3:24 8:16 9:15,20

10:5,18,21,25

11:9,10,12 12:8

13:3,12,12,13,14

13:18,18,19 14:13

14:14,15 16:2,6,7

16:16,17,19 17:11

17:12,16 18:3,9

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18:22,23,24,25

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23:11,12,13,13,14

24:4 25:24 27:15

27:21 29:2,9,16

29:25 31:5,8,10

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68:3,4

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58:19

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31:5,10 34:10,14

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limbo 66:6

limitation 30:15

limitations 11:7

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LINDERN 68:2,4

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methodologies

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Michael 54:23,23

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millions 55:14

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Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com

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