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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 + + + + +

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 LEAD REVIEW PANEL

 + + + + + 

 PUBLIC MEETING

 + + + + +

 WEDNESDAY, JULY 20, 2011

 + + + + +

 The meeting convened in Salon BCD

of the Marriott at Research Triangle Park,

4700 Guardian Drive, Durham, North Carolina,

at 9:00 a.m., H. Christopher Frey, Chair,

presiding.

CASAC LEAD REVIEW PANEL MEMBERS PRESENT:

H. CHRISTOPHER FREY, Chair

GEORGE A. ALLEN

HERBERT ALLEN

DEBORAH CORY-SLECHTA

CLIFF DAVIDSON

PHILIP E. GOODRUM

SEAN HAYS

PHILIP HOPKE

CHRIS JOHNSON

SUSAN KORRICK

MICHAEL KOSNETT

ROMAN LANNO

RICHARD L. POIROT

JOEL POUNDS

MICHAEL RABINOWITZ

WILLIAM STUBBLEFIELD

IAN von LINDERN

GAIL WASSERMAN

MICHAEL WEITZMAN
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U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF

PRESENT:

AARON YEOW, Designated Federal Officer

VANESSA VU, Director, SAB Staff Office

ELLEN KIRRANE

JOHN J. VANDENBERG

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

Convene and Welcome 5

Introductions of Panel Members, 

Purpose of Meeting, Agenda Review 10

EPA Presentation on the

Lead Integrated Science Assessment 22

Public Comment 52

Charge Question 1

Causal Framework/Study Selection 63

Charge Question 3

Ambient Lead 96

Charge Question 4

Exposure, Toxicokinetics, and Biomarkers 152

 4a - Exposure and Toxicokinetics 152

 4a - Biological Markers 168

 4a - Empirical Modeling 223

Charge Question 5

Integrated Health Effects of Lead Exposure

 231

 5a & 5e - Modes of Action and

 Dose Response 231

 5b & 5c - Health Endpoints 241

 5d - Integration of Epidemiological

 and Toxicological Evidence 251

Charge Question 7

Ecological Effects of Lead 282

Charge Question 6

Susceptible Populations and Life Stages 334

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

Charge Question 2

Integrative Health and Ecological Effects

Overview 352

Summary and Action Items 390

Adjournment 396

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

2 9:00 a.m.

3 MR. YEOW: Good morning, I'm Aaron

4 Yeow, the Designated Federal Officer for the

5 Clean Air Scientific Advisory Committee and

6 Lead Review Panel. 

7 I'd like to convene this public

8 meeting of the panel and to open the meeting

9 with a short statement.

10 The panel's meeting today and

11 tomorrow to conduct a peer review of EPA's

12 Integrated Science Assessment for Lead and a

13 consultation on EPA's Lead Risk and Exposure

14 Assessment Planning Document.

15 CASAC is a federal advisory

16 committee and by EPA policy, its meetings and

17 deliberations are held as public meetings that

18 meet the requirements of the Federal Advisory

19 Committee Act, also known as FACA.

20 Through their charter CASAC, the

21 panel's empowered by law to provide advice to

22 the administrator. Consistent with the
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1 requirements of FACA and with EPA policy, the

2 deliberations of the panel are conducted in

3 public at meetings for which advance public

4 notice is given.

5 The discussions and substantive

6 deliberations of the panel, its interactions

7 with the public and the agency are conducted

8 in sessions where I, as the DFO, am present to

9 ensure that the requirements of FACA are met.

10 This includes the requirements for

11 open meetings, for maintaining records of

12 deliberations of the panel, making available

13 to the public summaries of meetings and

14 providing opportunities for public comment.

15 We have received one set of

16 written public comments which has been

17 distributed to the panel and has been posted

18 on our website. And we also have one

19 registered public speaker for the ISA

20 document.

21 Minutes of this meeting are being

22 taken to summarize discussions and action

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1 items in accordance with the requirements

2 under FACA. These minutes will be certified

3 by the panel chair once completed.

4 I want to remind all in attendance

5 today of the status of the panel's compliance

6 with federal ethics laws. The SAB Staff

7 Office has determined that there are no issues

8 with conflict of interest or appearance of a

9 lack of impartiality for any of the advisory

10 panel members participating in this review.

11 I'd also like to note at this time

12 that Dr. Richard Canfield was not able to make

13 it at the last minute due to a family

14 emergency. 

15 I'd now like to turn the meeting

16 over to Dr. Vanessa Vu, Director of the SAB

17 Staff Office, and then over to Dr. Chris Frey,

18 Chair of the CASAC Lead Review Panel.

19 DR. VU: Good morning. I'm

20 Vanessa Vu. I'm the Staff Director of the EPA

21 Science Advisory Board. I'd take this

22 opportunity to welcome everyone to the public

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1 meeting of the Clean Air Scientific Advisory

2 Committee Lead Review Panel.

3 I want to thank Dr. Chris Frey,

4 and members of this distinguished CASAC panel,

5 members of this panel for your committed

6 public service to EPA. 

7 As Aaron has indicated, you'll be

8 asked to provide review comments on the

9 agency's document on the Integrated Science

10 Assessment of Lead, and tomorrow you'll be

11 conducting a consultation regarding the

12 agency's document regarding the scope and

13 method plan for the exposure and risk

14 assessment.

15 As part of the ongoing review of

16 the lead, you will be asked to provide

17 independent advice to the administrator

18 through the charter CASAC, and your report

19 will be considered by the charter CASAC for

20 approval before we transmit to the

21 administrator.

22 As Aaron has mentioned, that we do

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1 receive public comments. I ask that you

2 consider public comments, both written and

3 oral comments as part of your discussion

4 deliberation and your preparation of your

5 report.

6 I'd like to acknowledge and thank

7 members of the EPA Office of Research and

8 Development National Center for Environmental

9 Assessment, headed by Dr. John Vandenberg, who

10 will be here today to be part of the, give

11 presentation about the ISA, and his staff will

12 also respond to any clarification questions

13 you might have on the ISA.

14 And tomorrow you'll be joined by

15 Dr. Bryan Hubbell, from the Air office, the

16 Air Quality Planning and Standards Office,

17 OAQPS, will be here to talk about the scope of

18 the risk and exposure scoping plan.

19 Finally, I want to thank Aaron

20 Yeow, who's the Designated Federal Officer for

21 this panel, and all members of my staff and

22 contractor personnel for making this meeting
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1 happen.

2 So with that I'd like to turn the

3 meeting over to Dr. Chris Frey.

4 DR. FREY: Thank you, Vanessa. 

5 Good morning, and welcome to Research Triangle

6 Park on this nice, warm day.

7 Welcome to members of the panel

8 and to the EPA staff and to members of the

9 public. 

10 We'll begin with a round of

11 introduction of panel members, and then I'll

12 briefly talk about the purpose of the meeting

13 today and then review the agenda.

14 I am Chris Frey. I am a professor

15 of Environmental Engineering at North Carolina

16 State, and I'm serving as Chair of the Lead

17 Review Panel and I'm also on the statutory

18 CASAC. 

19 What I would like to do is start

20 with Dr. Allen, and if we could just go around

21 the table and please introduce yourself and

22 your affiliation. 

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1 Dr. Allen?

2 DR. FREY: Oh, Herb Allen. We

3 have two Dr. Allens, sorry.

4 MR. ALLEN: Only one, actually.

5 DR. ALLEN: I'm Herb Allen. I'm

6 from the University of Delaware Department of

7 Civil and Environmental Engineering.

8 DR. FREY: Oh, and please, yes,

9 please use the microphone. Thank you.

10 DR. ALLEN: Got to do this again? 

11 I'm Herb Allen. I'm from the University of

12 Delaware Department of Civil and Environmental

13 Engineering.

14 DR. LANNO: I'm Roman Lanno, Ohio

15 State University Department of Evolution,

16 Ecology and Organismal Biology.

17 DR. JOHNSON: I'm Chris Johnson. 

18 I'm currently Chair of the Department of Civil

19 and Environmental Engineering at Syracuse

20 University.

21 DR. POUNDS: I'm Joel Pounds from

22 the Pacific Northwest National Laboratory.

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1 DR. GOODRUM: I'm Philip Goodrum

2 with ERM in Syracuse, New York.

3 DR. HAYS: Sean Hays with Summit

4 Toxicology in Allenspark, Colorado.

5 DR. KOSNETT: I'm Michael Kosnett. 

6 I'm in the Division of Clinical Pharmacology

7 and Toxicology at the University of Colorado

8 School of Medicine, and also the Department of

9 Environmental and Occupational Health at the

10 new Colorado School of Public Health.

11 DR. WEITZMAN: And I'm Michael

12 Weitzman. I'm a professor of pediatric

13 psychiatry, and environmental health at the

14 New York University School of Medicine.

15 DR. CORY-SLECHTA: I'm Deborah

16 Cory-Slechta from the University of Rochester

17 medical school.

18 MR. ALLEN: I'm Mr. George Allen,

19 as opposed to Dr. Allen. That's how you tell

20 us apart. And I'm from NESCAUM, which is a

21 multi-state organization based in Boston that

22 works with the eight northeast states.

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1 DR. HOPKE: I'm Phil Hopke. I'm

2 the Director of the Institute for a

3 Sustainable Environment at Clarkson

4 University.

5 MR. POIROT: I'm Rich Poirot. I'm

6 with the Vermont Department of Environmental

7 Conservation.

8 DR. KORRICK: I'm Susan Korrick. 

9 I'm at Harvard Medical School.

10 DR. WASSERMAN: Gail Wasserman in

11 child psychiatry at Columbia Medical School.

12 DR. von LINDERN: Ian von Lindern

13 with TerraGraphics Environmental Engineering

14 in Moscow, Idaho.

15 DR. RABINOWITZ: I'm Michael

16 Rabinowitz. I'm a retired isotope geochemist.

17 DR. DAVIDSON: Cliff Davidson, in

18 Civil and Environmental Engineering at

19 Syracuse University.

20 DR. STUBBLEFIELD: Bill

21 Stubblefield, Oregon State University in the

22 Department of Environmental and Molecular
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1 Toxicology.

2 DR. FREY: Okay. Well, great. 

3 Thank you, and thanks to all the panel members

4 for agreeing to serve on this review panel. 

5 This is a multi-year adventure that we're

6 setting out on and your service is greatly

7 appreciated by EPA and it's an important

8 public service to the nation to provide

9 scientific advice regarding the development of

10 National Ambient Air Quality Standards.

11 There was an ulterior motive in

12 this, which was to practice using the

13 microphones. And when you make comments

14 during the discussions, please remember to use

15 the microphone so that you can be heard by all

16 in the room, and if we have anyone on the

17 phone so they'll be able to hear what you're

18 saying.

19 And just a reminder, if you have

20 any cell phones, please mute those. 

21 So Vanessa mentioned the purpose

22 of this meeting but just to reiterate, CASAC

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1 has essentially a mandate consistent with the

2 Clean Air Act to provide independent advice to

3 the EPA administrator regarding the technical

4 basis for EPA's National Ambient Air Quality

5 Standards. 

6 And so today we're going to be

7 focusing on providing that advice in relation

8 to the scientific basis for the National

9 Ambient Air Quality Standard for Lead.

10 The document we're reviewing today

11 is called the Integrated Science Assessment. 

12 And this is EPA's effort to compile all of the

13 relevant science that will then be the

14 foundation for whatever decision making is to

15 come in the subsequent months and years as we

16 go through this review process.

17 And just to quote from a memo that

18 the National Center for Environmental

19 Assessment sent to this panel, "The ISA is

20 intended to accurately reflect the latest

21 scientific knowledge useful in indicating the

22 kind and extent of identifiable effects on

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1 public health, which may be expected from the

2 presence of a pollutant in ambient air."

3 And of course, we're addressing

4 not just public health effects in the

5 deliberations today, but also what are known

6 as "welfare effects" or secondary effects. So

7 those are other effects that can include

8 ecological effects, for example.

9 So that's our charge, our broad

10 charge for today. And we have specific

11 questions that have been posed to us by EPA

12 that we will answer as we go through the day.

13 What I would like to do is then

14 review the agenda which you should have in

15 front of you.

16 And our next segment will be a

17 presentation by EPA on the Integrated Science

18 Assessment for Lead, followed by public

19 comments. And we have as I understand, one

20 public speaker.

21 Depending on the timing we might

22 take a break at that point. We'll then come

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1 and discuss the charge questions. The first

2 charge question has to do with the causal

3 framework and criteria for study selection for

4 studies considered in the ISA.

5 And for each charge question we

6 have lead discussants. So for example, for

7 Charge Question 1, Dr. Kosnett and Dr.

8 Davidson are the lead discussants.

9 Among the lead discussants we've

10 designated I guess a lead, lead discussant,

11 And that person with the asterisk on the

12 agenda for a charge question is the one who

13 we're asking to be responsible for developing

14 the consensus written response to that charge

15 question.

16 For many of the charge questions

17 there's maybe two discussants, sometimes

18 there's three, sometimes there's five, just

19 depending on the scope of the charge question

20 and the panel member expertise related to that

21 question.

22 Just to reiterate, the outcome of
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1 this meeting will be kind of three parts. One

2 is a letter to the administrator that contains

3 the high level comments, consensus comments

4 from the panel in about a two-page format. 

5 Then there'll be an attachment

6 that contains the consensus response to each

7 charge question, and so that part's going to

8 rely very heavily on the lead, lead

9 discussants drafting the written response to

10 those charge questions.

11 And then the third part is the

12 individual member comments. Most of you have

13 submitted individual comments prior to the

14 meeting. You are welcome to revise those

15 comments, and Aaron Yeow and I, later will

16 give you a deadline for submitting those

17 revised individual comments.

18 What I would like is for the lead,

19 lead discussants today to, at the end of the

20 discussion of each charge question to be

21 prepared to just reflect on what they think

22 the key points are in answering the charge

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1 question. That'll help us reach consensus or

2 understand what our consensus is.

3 What I'd like ideally by the end

4 of the day today, is that we have a pretty

5 clear idea of what it is we're going to say to

6 EPA in answering the charge questions. 

7 That'll also help me quite a bit in

8 formulating the letter to the administrator.

9 Let me just pause for a minute and

10 ask, are there any panel member questions

11 about that process? Okay.

12 All right, so returning to the

13 agenda, we'll first talk about Charge Question

14 1. We're going to skip Charge Question 2 and

15 save that for later, because that has to do

16 with the integrative summary in the ISA and it

17 would seem to make sense to come back to that

18 after we've considered all the constituent

19 parts of the ISA.

20 So we'll go from Charge Question 1

21 to Charge Question 3. Mr. George Allen and

22 Mr. Rich Poirot are the lead, lead discussants

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1 on Charge Question 3, so they jointly will

2 share responsibility for drafting the

3 consensus report for that charge question,

4 with the input of Drs. Davidson, Hopke and

5 Johnson.

6 As we go into Charge Question 4

7 that has subparts to it, so we've split it out

8 into an Exposure and Toxicokinetics part, a

9 Biological marker part and Empirical Modeling

10 part, and the discussants are indicated in the

11 agenda.

12 Charge Question 5 is also

13 subdivided into three parts. This is on the

14 top of the second page of the agenda. Modes

15 of Action and Dose-Response is one part,

16 Health Endpoints, and then Integration of

17 Epidemiological and Toxicological Evidence is

18 the last one.

19 Charge Question 7 is on Ecological

20 Effects of Lead, and we have a number of

21 experts in that area who will respond.

22 Charge Question 6 is on

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1 Susceptible Populations and Life Stages, and

2 then we'll come to the Integrative summary

3 related to Charge Question 2.

4 For each charge question, I'll

5 first recognize the lead discussants in order

6 of the lead, lead discussants and then the

7 lead discussants, and then I'll open it up to

8 anyone on the panel who wants to provide

9 input.

10 What I'd like to do is, if you

11 would like to be recognized to speak, I'll

12 scan the room. If you want to put your

13 placard on end to indicate you want to speak,

14 that's fine, or just get my attention.

15 I will keep a speakers list, and

16 we'll start with that process and see how it

17 works. If there's a topic under discussion

18 where you really want to respond to that

19 topic, I don't know if there's a good way to

20 indicate that. Maybe just wave your arms

21 frantically and then I'll know that you want

22 to get in on that part of the discussion, and
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1 we'll just try to manage that the best we can. 

2 But otherwise, I'll generally recognize people

3 in the order that I notice that they've

4 indicated they want to speak.

5 With that I think that's all I

6 need to say at the moment. Anything else from

7 the DFO? Okay.

8 All right, so with that I would

9 like to invite the U.S. Environmental

10 Protection Agency to go ahead and present on

11 the Integrated Science Assessment, and I guess

12 I'll turn it over to Dr. Vandenberg. Thank

13 you.

14 DR. VANDENBERG: Okay. Thank you

15 very much, Dr. Frey. I would like to welcome

16 the panel on behalf of the EPA and the

17 National Center for Environmental Assessment.

18 We very much appreciate the time

19 you have committed to review the draft

20 document now and in subsequent draft when we

21 consider your comments, and the time you've

22 taken to come here today and enjoy this nice,

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1 balmy weather we have outside.

2 So I'd also like to welcome the

3 SAB staff and the members of the public that

4 are here. 

5 We also are joined by a number of

6 the authors of the draft, and that's the NCEA

7 staff that are along the wall and in the back

8 as well as a number of ORISE fellows and

9 contractors. So welcome to all of you. We

10 appreciate your time and energy today as we

11 review this draft.

12 I'm going to provide a little bit

13 of context and then turn to Ellen Kirrane, who

14 is the overall Chemical Manager for the Lead

15 Integrated Science Assessment.

16 And then she'll be followed by

17 Debra Walsh, who is at the front with me as

18 well, who will discuss the Health and

19 Environmental Research Online system that you

20 have access to and how that works and is

21 intended as a support system for the review,

22 and also providing public access to the

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1 information that's used in the assessment.

2 Importantly, this is an Integrated

3 Science Assessment, which is different from

4 previous documents on lead which were called

5 Air Quality Criteria documents.

6 About three years ago, at the

7 direction of EPA upper management, we moved to

8 change the way we were structuring these

9 documents to try to have them be more focused

10 on the most policy relevant science and have

11 them be really more integrative and focused on

12 the information that is most important to

13 consider in setting the National Ambient Air

14 Quality Standards.

15 So we changed the title and we

16 also changed the document quite a bit. We've

17 constructed in the first couple chapters,

18 information on a framework that we use and

19 then we apply that framework in Chapter 2. 

20 And then the following chapters actually

21 provide the scientific review of the different

22 studies that were considered.

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1 One of the things that I'd like to

2 communicate is that we've, now this is our

3 fourth assessment, fourth or fifth assessment

4 now that we've applied the new framing of the

5 Integrated Science Assessments to, and we're

6 continuing to evolve these documents. 

7 And we very much benefit from the

8 input from CASAC. We've applied it to

9 particulate matter, to the NOx, SOx eco

10 assessment that was done some years ago to

11 carbon monoxide, and most recently to the

12 ozone assessment.

13 As a result of that we continually

14 get new ideas and new perspectives on how to

15 continually improve the document and we

16 certainly welcome your input on that. That's

17 the purpose of part of these charge questions,

18 is to give us ideas on how we might focus

19 that.

20 We are now awaiting the comments

21 from CASAC on the ozone first draft, so we're

22 just staggered a little bit here with the Lead
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1 ISA following the Ozone ISA. And there's been

2 a lot of really important and helpful comments

3 on the ozone document that we're benefiting

4 from and kind of we're waiting for the final

5 letter from CASAC. 

6 But one of the considerations

7 there that that panel has made is to do some

8 structural changes to the front of the

9 document where we look at the Introduction and

10 the Integrative summary as Chapters 1 and 2 in

11 the document that you have. 

12 And we're looking at ways to

13 better frame that to be a little bit more

14 focused and integrative right up front. So

15 we're continuing to evolve this and certainly

16 welcome the Lead Panel input on it as well.

17 So what I'd like to do is just

18 review briefly the process that we use. On

19 this slide which you see to the top left is a

20 workshop on science policy issues.

21 This is where we benefit from the

22 prior review and the development of new

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1 science that has occurred since that time. 

2 And we bring in a number of experts and the

3 public are invited as well, to share their

4 views on what most important science issues

5 are that remain for us to consider and to

6 focus on.

7 That goes into an integrated

8 review plan that then goes through formal

9 CASAC consultation and public comment. Again

10 I think you've all seen that. That helps us

11 make sure the document is structured around

12 the most important issues.

13 Flowing from that plan are

14 actually two different documents. The

15 Integrated Science Assessment, which we're

16 reviewing today, and then the Risk and

17 Exposure Assessment plan, which is what will

18 be discussed tomorrow, ideas about that.

19 And again, CASAC involvement and

20 they're, ultimately information is flowing

21 into the policy assessment that is then, that

22 is actually developed by our colleagues in the

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1 Office of Air Quality Planning and Standards,

2 and that goes forward into the decision making

3 and support for the administrator's decisions

4 on what to do in terms of proposing standards. 

5 Again, public review and comment, and then

6 finally, a final rule making that will occur.

7 This process takes a number of

8 years to go through, and so on the next slide

9 what you see is, the schedule for this review

10 is we are at the July 20-21st timeframe, the

11 highlighted bar here, and the first draft is

12 being reviewed today.

13 As you see, our second draft is

14 anticipated for December of this year. So

15 upon your considered comments and review and

16 comments back to the administrator, we'll

17 revise the document and provide it again with

18 ample opportunity for your second review as

19 well as for public comment.

20 Our goal is to finish the document

21 in the late winter or early spring of 2012,

22 and thereby that sets the stage for again the

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1 subsequent steps which is the Risk and

2 Exposure Assessment if it's warranted, and

3 decisions made to proceed with that. Finally,

4 the policy assessment and rule making.

5 So we have matched up these

6 meetings to optimize your time and energy. 

7 And so as you see by the bar to the far right,

8 the meeting today is both to discuss the first

9 draft ISA as well as the planning document for

10 the Risk and Exposure Assessment, and then

11 subsequently in the February, March timeframe

12 is to, just the next steps of that process.

13 So the goal here is rule making

14 that will finish up late in 2014, and we are

15 very much again recognizing the several year

16 effort that it will take on your part to

17 contribute to this overall process. So thank

18 you again for your time.

19 I very much want to acknowledge and

20 extend my personal appreciation to the Lead

21 ISA team. And what you see again is a number

22 of the authors here in the room as well as
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1 external authors, experts that we bring in to

2 help us as we frame certain issues that are

3 very important for this Integrated Science

4 Assessment.

5 So with that what I'd like to do is

6 turn to the team leader which is Ellen

7 Kirrane, who will walk through an overview of

8 the ISA and in particular, the charge

9 questions for your discussion today.

10 DR. KIRRANE: Thank you. This

11 slide shows the structure of the ISA. You've

12 seen the charge questions, and as you know

13 there's a general charge that addresses the

14 document as a whole and there are also

15 specific charge questions that are linked to

16 each chapter of the ISA.

17 I'm going to go through the charge

18 questions, and there are a lot of words on the

19 slide, so we've used the blue text and the

20 underline to highlight key phrases that we've

21 just selected to focus the presentation.

22 So for the general charge what

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1 we're doing, we're aiming to present the most

2 policy relevant science, and we're building on

3 the findings from the 2006 Air Quality

4 document and also including new science.

5 It's our intention though to retain

6 adequate discussion of older studies that

7 remain the definitive works or may be open to

8 reinterpretation, so we're requesting comments

9 on how well we achieve that goal.

10 Turning to the next slide, the

11 specific charge for Chapter 1. The selection

12 criteria used to identify studies for

13 inclusion in the ISA are described in Chapter

14 1 of the document. We're requesting comment

15 on whether these selection criteria were

16 applied appropriately and consistently.

17 We've considered studies that are

18 approximately within one order of magnitude of

19 the current exposure levels, and we've

20 included some occupational studies. 

21 And the example that we have

22 parenthetically in the charge question

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1 addresses the extent to which, or requests

2 comment on how well we have consistently

3 incorporated those occupational studies across

4 endpoints.

5 This charge question also addresses

6 HERO, which will be discussed later in the

7 presentation. 

8 So the slide for Chapter 2, the

9 specific charge, Chapter 2 is an integrative

10 summary of the ISA. We're requesting comment

11 on whether it's a useful summary and whether

12 it's effectively conveying the needed

13 information.

14 Also we are asking if the framework

15 for causal determination is appropriately

16 applied for both the health and the ecological

17 endpoints. 

18 We noticed or observed a

19 substantial overlap between ecological and

20 health endpoints, and we've also observed that

21 the health and ecological effects are mediated

22 through interconnected modes of action.

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1 So we found an opportunity for

2 integration there and we are requesting

3 comment on whether this particular approach is

4 useful and effective.

5 And we've included some slides

6 from, just for a content to the ISA just as

7 examples. This is the framework of causal

8 determination that is described in detail in

9 Chapter 1 of the document. We evaluate the

10 weight of the evidence and apply this five11 level framework.

12 This is a table that appears in the

13 document in Chapter 2. It's adapted from

14 Table 2.5. And it's a summary of the causal

15 determinations for both health and ecological

16 effects. The health effects, as you can see

17 causal determinations were made for all of the

18 outcomes evaluated except for cancer, where a

19 likely causal relationship was determined.

20 You can see the overlap between the 

21 human health and ecological causal

22 determinations here. 
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1 Towards the end of the slide where

2 we start with bioaccumulation there are no

3 causal determinations for the health outcomes

4 and those, for those outcomes. But we do note

5 that there is evidence from the health studies

6 that support and supplement the evidence and

7 the ecological literature base.

8 The next slide addresses the

9 specific charge for Chapter 3. Chapter 3

10 provides a wide range of information to inform

11 both exposure and health sections of the ISA.

12 And we're requesting comments on whether the

13 information is conveyed appropriately and

14 appropriately characterized. 

15 The information included is lead

16 source characteristics, fate and transport,

17 lead monitoring, spatial and temporal

18 patterns. 

19 And specifically we are requesting

20 comment on the relationship between ambient

21 air concentrations and concentrations of lead

22 in other media, and whether we have done an

Page 35

1 adequate job to characterize those

2 relationships.

3 The specific charge for Chapter 4

4 is here. Chapter 4 covers lead exposure,

5 toxicokinetics and biomarkers. It's a three6 part question and Part A is on this slide.

7 We are requesting comments on how

8 well the choice and emphasis of topics in the 

9 chapter provide a useful context for human

10 health effects of lead in the ISA as well as

11 whether the ISA adequately describes

12 imbalances air related and non-air related

13 pathways of lead exposure.

14 Parts B and C are on this slide

15 also addressing Chapter 4, how well does this

16 section reflect the current state of the

17 knowledge of lead biomarkers and their

18 interpretation as it relates to both exposure

19 and dose?

20 And Part C, does the section

21 accurately reflect what is known about air

22 lead/blood lead relationships? And I've

Page 36

1 included a table that we've adapted from the

2 ISA here. This is Table 2.7 in Chapter 2 of

3 the document. 

4 The relationship between blood and

5 air lead was very important in the 2008 NAAQS

6 consideration because it allowed the

7 relationship between what's in the blood and

8 what's in the air to be characterized.

9 We have here the studies of

10 children that supply this relationship, and in

11 the far right column we have the slope. And

12 the slope, the units are in micrograms per

13 deciliter of blood per unit of air and

14 micrograms per cubic meter. 

15 And for nonlinear models the nature

16 of the slope depends on where we are in the

17 distribution of air concentrations. 

18 So we have computed the slopes, if

19 you look at the footnote, at 0.15 micrograms

20 per cubic meter as well as 1 microgram per

21 cubic meter for those nonlinear models. And

22 there's a difference, because the log log

Page 37

1 models have a larger slope at the lower

2 concentrations and log linear models have a

3 smaller slope at the lower concentrations.

4 And something in terms of

5 interpreting those slopes, in the third bullet

6 we were just pointing out that the

7 concentrations range at which the slopes were

8 derived vary quite a bit, and some are very

9 low. 

10 And in the case of Brunekreef the

11 range is 0.2 to 10 micrograms per cubic meter,

12 so in that case it's outside the range of 0.15

13 where we're deriving this slope.

14 Chapter 5 of the document presents

15 the health effects of lead. The evidence is

16 organized by health effect category then

17 endpoint and scientific discipline. 

18 And Part A of this question, and

19 this is a five-part question, we are asking

20 about the mode of action and to what extent

21 are the discussion and integration of the

22 potential modes of action underlying the
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1 health effects of lead presented accurately

2 and in sufficient detail.

3 Mode of action is presented at the

4 beginning of Chapter 5 and then linked to

5 subsequent health effects later in the

6 document. 

7 We do this because many modes of

8 action are common across health effects and we

9 find that this organizational scheme helps us

10 eliminate some redundancy in the document. So 

11 basically is this effective, is this approach

12 effective?

13 This is a figure that appears in

14 the document. It's showing the lead-induced

15 events upstream from the observed health

16 effects, and you can see that there are

17 multiple modes of action responsible for the

18 health effects. 

19 Altered ion status is the major

20 unifying mode of action, and it's the theme

21 around which the chapter was organized.

22 The second part, Part B, is

Page 39

1 requesting comment on the clarity and

2 effectiveness of the figures and tables in the

3 document. We're trying to accomplish quite a

4 bit in a snapshot in those figures, and I have

5 a few examples. 

6 This is a figure that appears in

7 Chapter 2 of the document. It's the lowest

8 blood lead levels at which health effects are

9 substantiated. 

10 As I'm sure you know, we've

11 determined causality depending on the larger

12 health effect category. 

13 And this is a table that breaks it

14 down by endpoint and links those endpoints to

15 blood lead levels that that endpoint is well

16 substantiated. So does this type of figure

17 help convey useful information?

18 This is another example of a figure

19 from the ISA. It appears in Chapter 5 of the

20 document. It's a figure of full-scale IQ in

21 children, and the studies are organized by

22 mean blood lead level.

Page 40

1 The change of an IQ is standardized

2 at 1 microgram per deciliter of blood, and

3 some of the models are nonlinear so the change

4 in IQ also similar to the slopes for the air

5 to blood relationships. The slopes in these

6 studies also depend on where in the

7 distribution of blood lead level you are. So

8 again, these are standardized at 1 microgram

9 per cubic meter.

10 There are columns for the timing of

11 blood measurement, mean blood lead level from

12 the study as well as age of the children. 

13 Continuing with the third part of

14 Chapter 5 charge question, should discussions

15 of specific endpoints be expanded to provide

16 a more comprehensive assessment?

17 Part D asks specifically if the

18 integration of the epidemiologic and the

19 toxicological evidence is accurate and well

20 characterized. 

21 We have a figure in, it appears in

22 both Chapter 2 and Chapter 5 of the document

Page 41

1 that is an example of one approach for

2 integrating the document. This figure is

3 meant to, in sort of a snapshot, show the

4 consistency between the toxicology and the

5 epidemiology for parallel endpoints.

6 The purple is epidemiologic

7 findings, and the toxicological findings are

8 in green. And you can also see in this figure

9 the consistency and coherence with the modes

10 of action at the bottom of the period leading

11 all the way up to more downstream effects,

12 learning, memory, behavior, mood disorders and

13 motor function.

14 So this is one example of how we

15 are integrating the findings, and it was the

16 concepts that I just mentioned are important

17 in our causal determinations.

18 The last part of Chapter 5 we are

19 asking for comment on the extent to which the

20 expanded discussion of the concentration

21 response function and the shape of the

22 function is consistent and informative. 
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1 And that discussion appears in

2 Chapter 2 of the document and is also expanded

3 upon in Chapter 5. 

4 So moving on to the specific charge

5 for Chapter 6. We have several key phrases

6 underlined here. Are the characteristics

7 included within the broad susceptibility

8 categories appropriate and consistent with the

9 definitions? 

10 Are there key susceptibility

11 factors that were not included and need to be

12 added? Is it appropriate to include material

13 on susceptibility factors related to exposure 

14 and dose as well as effect of factors that

15 modify the associations between lead and

16 health outcomes?

17 The definition of susceptibility is

18 listed here. And this is the definition that

19 we currently use. It's in the document. 

20 CASAC has been discussing this definition as

21 part of the ozone review. We expect to make

22 some refinements based on that review of the

Page 43

1 definition that we're using.

2 Right now it's an all-encompassing

3 definition and it's designed so that we don't

4 need to distinguish between the different

5 terms like susceptible, vulnerable, at risk

6 and sensitive.

7 We chose an umbrella term because

8 it's very often difficult to categorize the

9 factors into those terms. So we opted for

10 that umbrella term.

11 This is the listing of susceptible

12 populations and lifestages identified in the

13 document. 

14 The charge question also mentions

15 that susceptibility to lead is discussed in

16 other parts of the document, not just in

17 Chapter 6. 

18 So we're also requesting feedback

19 under this charge question on whether other

20 sections of the document adequately cover and

21 appropriately distinguish lifestage dependent

22 differences, specifically the differences

Page 44

1 between children and adults as they relate to

2 the effects of lead in the mode of action

3 section, for example, the exposure section,

4 toxicokinetics sections.

5 The last set of charge questions

6 relates to Chapter 7. Chapter 7 is the

7 ecological effects chapter. Several new

8 approaches were tried in this chapter.

9 In addition to considering effects

10 of lead in terrestrial and aquatic systems,

11 the eco team took a look across taxa at

12 endpoints such as neurobehavior, development

13 and reproduction.

14 Where appropriate toxicological

15 evidence was used to support findings of the

16 effects of lead in those terrestrial and

17 aquatic systems. Bioaccumulation was

18 considered as an effect, as it affects

19 ecosystem services.

20 Causal determinations at the

21 species level were considered when evaluating

22 causality at the community or ecosystem scale. 

Page 45

1 And the impacts to ecosystem services, the

2 benefits people obtain from ecosystems were

3 evaluated in this assessment.

4 This is a slide, the mode of action

5 slide you've seen before. This is the slide

6 that shows a table showing the shared modes of

7 action between the health and evidence in

8 biota.

9 These are the health effects that

10 are common to both human health and ecosystems

11 and the causal determinations are also

12 included here. These are the ecosystem

13 effects for which we did not do a causal

14 determination for health effects, but as I

15 mentioned before some of the evidence in the

16 health literature does support these causal

17 determinations as well.

18 And finally, for the specific

19 charge on Chapter 7, has the ISA adequately

20 characterized the available information on the

21 relationship between lead exposure and the

22 effects of individual organisms and ecosystems
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1 as well as the range of exposure

2 concentrations for the specific endpoints?

3 So with that I'd like to turn it

4 over to Debra Walsh to discuss HERO.

5 MS. WALSH: Good morning. HERO,

6 Health and Environmental Research Online, so

7 this is a system that we've been developing

8 for several years now. Actually we started

9 HERO when we started changing from the Air

10 Quality Criteria document into the Integrated

11 Science Assessment.

12 And it's been an evolving system

13 that we really try to provide an agile

14 environment so that we develop something, we

15 try it, we use it, if it works we keep it. If

16 it doesn't work we try to change it and make

17 it a useful tool not only to the researcher

18 but also as a way of providing some

19 transparency to the stakeholders and to the

20 public.

21 So here you see two websites. The

22 first one is HERO Net, and this is the tool

Page 47

1 that we use to facilitate assessment

2 development. This has been primarily used for

3 NCEA and partners. And partners we look at

4 certainly in this for the ISAs is OAQPS. 

5 So they have been in HERO Net. It

6 allows them access to some different tools

7 than you will see actually at the public

8 website, which is just epa.gov/hero, that we

9 use to provide transparency to stakeholders

10 and public.

11 All right. So this is the public

12 page for HERO and it gives you some general

13 information about the database and some menus

14 where you can get some additional information

15 on other pages.

16 This is what the public page would

17 look like for the Integrated Science

18 Assessments as well as the IRIS assessments

19 that we do in other parts of NCEA. 

20 At the first tab under the

21 Integrated Science Assessments for the air

22 pollutants you see lead. 

Page 48

1 And we now provide not only the

2 references for the, that were actually cited

3 in the document, we've done that back to PM I

4 think was the first one where we actually, you

5 could see the document and you could actually

6 see all the references as a bibliography if

7 you wanted to print that off and export that

8 to use those references.

9 But we're also providing the

10 references that were considered. And we did

11 that first for ozone, which was the previous

12 one to lead, and then I'm going to show you

13 where it's a little bit different in how we're

14 providing those references that are

15 considered.

16 This is the HERO Net page. So if

17 you look on the menu far on the left, you'll

18 see the same kinds of things that you would on

19 the public side where we can provide the

20 abstract, the citation and information on how

21 to get the article.

22 Down at the bottom of that white

Page 49

1 bar there in the middle you'll see some

2 different tools like LitSearch, LitBrowser,

3 LitReporter and Screener and LitCiter, and

4 those are the internal tools we use in

5 assessment development.

6 Now we have as of ozone entered

7 CASAC, so all of the panel members here should

8 be entered into HERO Net. So you would see

9 this exact page if you go to epa.gov/heronet

10 so you would now have access to see the same

11 kinds of things that we have as tools in

12 developing the assessment.

13 So this is the PM document. This

14 was the first ISA that we actually used the

15 tool we call LitCiter, one of the modules, to

16 hyperlink the reference inside the document.

17 So if you would look at that number

18 that's underlined and in blue, we've changed

19 that now with the lead ISA. But you would

20 click on that link if you were reading the

21 document, and that HERO ID's a unique number

22 to that reference.
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1 And this is a Word plugin that we

2 use that's very much cite while you write. 

3 It's now based off of EndNote. And then the

4 reference is available to the public where

5 they can not only see the citation but

6 actually read the abstract. 

7 Now this is the lead landing page. 

8 This is different. This is a new, as I've

9 mentioned earlier we're trying to really

10 incorporate whatever we can in feedback from

11 the public and from CASAC to try to provide

12 more transparency to how we develop our

13 documents.

14 So for lead you would not only see

15 the references cited but those that were

16 considered, and we've organized them by

17 filters you can see over on the right, by

18 discipline and subject matter.

19 And as we're moving forward to NOx,

20 which will be the next ISA we're working on,

21 we're trying to provide even more information

22 to the public and to CASAC, and we're using

Page 51

1 LitReporter. 

2 So our plans as we're developing

3 that ISA is to have in addition to the actual

4 reference, to have some specific information

5 that would pull out about that material that

6 would be available for review.

7 This is a start toward our ultimate

8 goal which is a LitExtractor where we would

9 actually pull the data out of the papers and

10 into this relational database that you could

11 query, export and then do analysis on actual

12 numbers.

13 So that's the introduction to HERO. 

14 I'll be happy to take any questions. And we

15 really would like for you to use the database. 

16 We really want your feedback, so if you have

17 any difficulties at all. 

18 I know there were a couple members,

19 I think we resolved that so feel free to

20 contact us. We really want it to be a tool

21 for you to use in your review of the ISA.

22 DR. VANDENBERG: Dr. Frey, back to

Page 52

1 you.

2 DR. FREY: Okay, well thank you. 

3 Do the panel members have any questions of

4 clarification at this point? I don't see any. 

5 Thank you. Thank you very much.

6 I think at this point we will go to

7 the public comment session, and I understand

8 we have one speaker registered. Craig

9 Boreiko, and is that correct?

10 DR. BOREIKO: Boreiko.

11 DR. FREY: Boreiko. Okay, so we

12 can offer you five minutes.

13 DR. BOREIKO: Sure.

14 DR. FREY: Strictly enforced, and

15 are you ready? If you're ready you may begin.

16 DR. BOREIKO: My name is Craig

17 Boreiko. I'm Director of Science Programs

18 with the International Lead Zinc Research

19 Organization, a couple exits west on the I-40

20 is where we're based.

21 I'm basically here one, because I'm

22 a glutton for punishment and two, we are

Page 53

1 supported by the industry and that includes

2 the Association of Battery Recyclers, who have

3 independently filed comments, and the

4 International Lead Association, which is

5 London based.

6 Copies of my comments are available

7 including an annotated version with references

8 and what have you. 

9 I've been through the ISA, granted

10 perhaps not as in depth as I would have liked

11 to have gone through it, but did find it to

12 deviate from previous criteria documents in a

13 number of significant ways, some good, some

14 I'm not so sure about.

15 The preface on the issues of

16 causality and how one determines causality I

17 found to be valuable and interesting. And

18 given the pressure the agency has been under

19 for a number of quarters on its risk

20 assessment procedures, I can understand the

21 inclusion of such a section. 

22 I did find it difficult to evaluate
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1 because it seems to have lowered the terms of

2 engagement if you will or criteria for

3 causality, but very difficult to evaluate when

4 placed within the context of lead where you

5 can pretty much say anything you want about

6 lead that's bad and people are going to say

7 yes, okay, that's true.

8 The task was made doubly difficult

9 by the fact that even though causality

10 criteria are put forward in the document, I

11 did not find that they were rigorously applied

12 in a number of instances within the body of

13 the ISA itself. And I'll just give a couple

14 of examples of that.

15 Confounder and co-exposures, we all

16 know that they are important in the

17 consideration of environmental neurotoxicants. 

18 This is particularly important for

19 lead, where lead is really a signature marker

20 if you will for socioeconomic disadvantage and

21 adverse living circumstances, what have you.

22 Scant attention is paid by the ISA

Page 55

1 to the causality guidelines with respect to

2 confounders that appear to influence the

3 outcome of lead epidemiology studies, and this

4 includes some of the newer papers that have

5 come out that have defined confounder of

6 Surkan and what have you that we know are

7 important in lead/child development studies,

8 and yet up to this point in time have not been

9 considered by most investigators.

10 Gulson published a paper that

11 produced a firestorm of response a few years

12 back, talking about other environmental

13 neurotoxicants that might be present in

14 influencing the outcome of lead/development

15 studies. 

16 The paper's not mentioned and

17 neither is the literature that documents the

18 impact of other neurotoxicants that have an

19 adverse impact upon child development.

20 I mention that only because while

21 the lead literature does not pay attention to

22 those environmental toxicants, those

Page 56

1 environmental toxicants are conducting their

2 studies and correcting for the effects of

3 lead.

4 The ISA does achieve a consistent

5 narrative voice. At some points I found it

6 did so by neglecting or in some cases

7 essentially misrepresenting some of the

8 studies that it was discussing.

9 Table 2.2, you've got a discussion

10 of the effects of lead on end-of-grade testing

11 by Miranda. The ISA will give a page or two

12 of discussion of that paper.

13 DR. FREY: Thirty seconds.

14 DR. BOREIKO: Thirty seconds. And

15 then essentially give passing mention to a

16 paper by Chandramouli et al. and say in a

17 sentence or two and they fundamentally found

18 the same thing.

19 Actually read the paper and they

20 say yes, there are effects under ten, and oh

21 by the way there's a threshold at five. That

22 study comes from the ALSPAC study that the

Page 57

1 U.K. government runs with some frequency.

2 I'll just make one final comment on

3 issue of quantitative emissions. You've got

4 an estimate of 1,200 tons of anthropogenic

5 emissions. I did some quick comparisons. I

6 know the numbers are difficult to come up

7 with, but what are the estimates of natural

8 emissions to the atmosphere?

9 Well, in '89, Nriagu was estimating

10 about 12,000 tons or about ten times the

11 amount globally, so U.S. 1,200 tons, probably

12 about equivalent to what you would expect from

13 natural emissions. More recently, Richardson

14 et al. estimated North American natural

15 atmospheric emissions to be 36,000 tons,

16 considerably larger. 

17 I guess my main point is, is that

18 current anthropogenic emissions are

19 quantitatively probably about the same if not

20 less than those that are coming from natural

21 emission sources. It causes me to wonder

22 whether further reductions in anthropogenic
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1 emissions are likely to yield measurable

2 public health or environmental benefits.

3 Thank you.

4 DR. FREY: Okay, thank you very

5 much. Are there any questions of

6 clarification from the panel?

7 Yes, Dr. von Lindern?

8 DR. von LINDERN: Craig, you said

9 you submitted comments.

10 DR. BOREIKO: Yes, they are

11 available. I have copies with me and they're

12 on the CASAC website.

13 (Off microphone discussion)

14 DR. FREY: Yes, Dr. Weitzman?

15 DR. WEITZMAN: May I ask you to

16 repeat or clarify a comment that lead being a

17 marker for other types of socioeconomic

18 disadvantage so that I might respond

19 appropriately?

20 DR. BOREIKO: I would say to the

21 child development community at large lead

22 serves as a marker for socioeconomic

Page 59

1 disadvantage. Lead exposure is -- I should

2 say invariably you oftentimes find that

3 socioeconomic exposure is associated with risk

4 factors for lead exposure as well as other

5 social and other factors that have adverse

6 impacts upon child development.

7 DR. WEITZMAN: So may I respond to

8 that?

9 DR. FREY: I think if it's in the

10 spirit of clarification. If it's more

11 deliberation then I think we could reserve

12 that for the later discussion.

13 DR. WEITZMAN: No, I think it's

14 clarification. 

15 DR. FREY: Okay.

16 DR. WEITZMAN: I think if you look

17 at the recent CDC publications you'll find

18 that that's an antiquated statement. That in

19 the United States at this particular point a

20 lot of the racial economic differences have

21 gone away. 

22 I'd also like to point out two

Page 60

1 other points, which is that there is a fairly

2 robust literature looking at middle class

3 children and a related literature that looks

4 at the multiplicative effect if you will of

5 lead when it's combined with socioeconomic

6 disadvantage. 

7 And I take great issue with the

8 statement that the lead literature doesn't try

9 to control for confounders. And there are any

10 number of studies that form the central opus

11 upon which we understand lead's effects and

12 the population basis on children that control

13 for as many as a dozen different confounders.

14 DR. BOREIKO: I would be in

15 complete agreement with you there. I would

16 say that there is not systematic treatment of

17 that issue within the ISA, and that is where

18 I have problems, because that was stressed as

19 being very important within the context of

20 establishing causality. 

21 Within the context of the ISA they

22 acknowledge confounding but they do not

Page 61

1 subject it to the sort of systematic analysis

2 and treatment that you have suggested is

3 necessary and I would agree.

4 DR. FREY: Okay, yes?

5 DR. LANNO: Just a comment on the

6 anthropogenic versus natural lead emissions. 

7 You mentioned that the natural lead emissions

8 are about ten-fold higher, is that correct? 

9 Am I interpreting that correctly?

10 DR. BOREIKO: I'm flashing back to

11 '89 and the classic Nriagu paper where global

12 emissions, I want to say global emissions

13 were, natural emissions were estimated to be

14 ten times higher. But that's global. You

15 have to scale down to the U.S.

16 The only other more recent

17 reference I was aware of was one that came

18 from Canada, a geological survey, which was

19 about 36,000 tons for North America including

20 Canada, Mexico.

21 DR. LANNO: Am I that clear

22 understanding that you said that reducing the
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1 anthropogenic emissions may not make that much

2 of a difference in global scale or U.S. scale

3 overall?

4 DR. BOREIKO: If those estimates of

5 natural emissions are correct, yes.

6 DR. LANNO: And I guess if it's

7 general distribution I might agree with you,

8 but I think that if we look at localized

9 inputs there may be situations where --

10 DR. BOREIKO: Point sources, sure. 

11 And constraints of time were such that I

12 didn't get into it, but you really don't find

13 within the ISA, at least I didn't see within

14 the ISA the establishment of a, what is the

15 contribution of air lead to current blood lead

16 or to the health impacts that we are concerned

17 with? 

18 Monitoring data from the U.S. is

19 largely nonexistent for most counties. Most

20 air monitoring stations really belong as

21 relics in the Smithsonian Institute as opposed

22 to where they are.

Page 63

1 We have a hard time relating air

2 lead with any accuracy to current blood leads.

3 DR. LANNO: Okay, thanks.

4 DR. FREY: Okay, thank you.

5 Well, we're a little bit ahead of

6 schedule, and I would propose that we just

7 move forward to discussing Charge Question 1

8 and then take our break after that discussion. 

9 And our lead discussants on Charge Question 1

10 are Drs. Kosnett and Davidson. 

11 So Dr. Kosnett, the floor is yours.

12 DR. KOSNETT: I felt that the

13 criteria of using, or concentrating on

14 epidemiological studies that were within one

15 order of magnitude at the general population

16 blood lead range is reasonable. 

17 I mean if we consider that based on

18 the latest NHANES analyses, the 95th

19 percentile is approximately 4.2 or right

20 around there micrograms per deciliter. That

21 means we're looking at literature that has

22 considered human exposures associated with

Page 64

1 blood lead concentrations up to about 40, you

2 know, give or take a few points. 

3 And I think that that's certainly

4 reasonable for a document that intends to

5 focus on environmental as opposed to

6 occupational lead exposure, and I thought that

7 that was reasonably applied and consistently

8 applied throughout. 

9 The charge also asks us about the

10 HERO system. I thought it was great and I

11 enjoyed using it. I think it's a tremendously

12 helpful public resource to have that. 

13 We really weren't asked to, the

14 charge question and I read it, didn't ask us

15 specifically to say what we think about the

16 framework for causal analysis and weight of

17 the evidence, right, I mean that was my

18 understanding. But I mean I thought it was

19 nice to see it in there and how it was laid

20 out and, you know, the explanations of Sir

21 Bradford Hill's criteria and how they apply.

22 I think as we get into further

Page 65

1 point, discussion points on how those were

2 applied and how transparent the causation

3 analysis was for various endpoints, I'll have

4 more comments. But since I don't think those

5 were covered in specifically Charge 1, I can

6 be brief and end there.

7 DR. FREY: Okay, great.

8 Dr. Davidson?

9 DR. DAVIDSON: I agree with Dr.

10 Kosnett. I think that Chapter 1 had a certain

11 consistency and that the criteria of

12 considering studies within one order of

13 magnitude of the current exposure is

14 reasonable.

15 I also liked the HERO network. I

16 thought that it worked very well. And I have

17 a number of typographical suggestions and some

18 editorial suggestions. 

19 One specific comment in terms of

20 making the document shorter, there is a short

21 section that deals with human exposure in

22 controlled chamber studies, and my suggestion
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1 would be that that paragraph might not need to

2 be included since as the document points out,

3 lead exposures are not done in chamber

4 studies. Except for that I have no other

5 comments.

6 DR. FREY: Okay. Other members of

7 the panel? Dr. Hopke?

8 DR. HOPKE: Okay. I'd like to be

9 a bit of an iconoclast here. And one of the

10 questions is, why do we still need lead as a

11 criteria pollutant? 

12 You know, we could ban leaded

13 avgas, take the wheel weights off of cars and

14 now we're down to primary and secondary

15 nonferrous metal smelters which could be

16 handled under Section 109 given the fact that

17 lead is a hazardous material.

18 And so I think there still needs to

19 be some, there needs to be at least some

20 rationale to me as to why we can't declare

21 victory and move on and look at potentially

22 other criteria pollutant, things that should

Page 67

1 become criteria pollutants because they're

2 much more widespread and likely to have much

3 more of a problem. 

4 Not that lead is not still a

5 problem, but there are better ways to deal

6 with it. There may be better ways to deal

7 with it than as a criteria pollutant. And,

8 you know, at least some rationale in there for

9 why this continues to be needed as a criteria

10 pollutant I think would be very helpful to all

11 of us.

12 DR. FREY: Okay, thank you.

13 Dr. von Lindern?

14 DR. von LINDERN: Well, I'll be the

15 guy from the other side. I have problems with

16 the ISA process, and maybe this is the right

17 place to bring that up. I don't know.

18 But this limitation on looking at

19 only one order of magnitude with regard to

20 exposure excludes 90 percent of the world. 

21 There are high exposures going on in the rest

22 of the world, and I don't see any of that

Page 68

1 information ever reaching the policy decision

2 makers through the ISA process.

3 Also there's very, very little

4 exposure in this entire document. In fact, I

5 think the conclusion that it's leading to is

6 that there's really no need to redo the risk

7 assessment because there's no new data.

8 What in that ISA process then

9 information is going to get to the

10 administrator to make a policy decision if

11 there's no new work done? 

12 So we have a great literature

13 review. We have a fantastic literature review

14 on health and environmental effects, but we

15 have no information on exposure and we have no

16 information on what's going on with lead in

17 the rest of the world. 

18 Much of which is happening because

19 of U.S. policy. We have sent our problems

20 overseas and I don't see anything in this

21 document that informs the administrator

22 eventually of that problem. 

Page 69

1 So I'm going to throw these arrows

2 at this agency for the next four years, and

3 I'm hoping that it hits somewhere within the

4 science and policy people because it seems to

5 be avoided in this first step.

6 DR. FREY: Yes, I guess I'll just

7 make a comment that, you know, in some sense

8 we're a bit constrained under the framework of

9 NAAQS which may or may not be amenable to

10 addressing some of the issues that you're

11 raising.

12 I think Dr. Hopke's point is

13 probably something that has to be borne in

14 mind as we go through this process, probably

15 not something that this panel can decide. 

16 Maybe the panel at some junctures can make

17 recommendations as it sees fit based on

18 science. 

19 But yes, Dr. Vandenberg, I think

20 you wanted to comment?

21 DR. VANDENBERG: I'd just like to

22 clarify again, one of the first slides that I
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1 showed had the process of the different, in

2 some sense the different pieces of the

3 process. And the exposure assessment and risk

4 evaluation if it's decided to be pursued is

5 actually in the companion document to the

6 ISAs. 

7 The ISAs typically do not include

8 the consideration of what either measured or

9 projected human exposures are given the

10 current sources and distribution of sources,

11 so that's really brought into the risk and

12 exposure assessment which is what you'll be

13 discussing tomorrow. 

14 So I can appreciate your concern

15 saying well, where is that? Well, that's

16 actually in the companion document that's

17 developed by our colleagues in the Office of

18 Air Quality Planning and Standards, and that's

19 partly because the monitoring system for

20 ambient air quality monitoring is organized by

21 the states with EPA support and so that's

22 where that data is obtained is evaluated. 

Page 71

1 And then the different options for

2 policy to look at the potential benefits for,

3 or the effects on risk with different policy

4 options is actually evaluated by again the

5 risk and exposure assessment and feeding into

6 the policy assessment. 

7 So there's a set of really three

8 different potential documents here that

9 together form the basis for the

10 administrator's, supporting the

11 administrator's decision. And so perhaps that

12 speaks to some of your concern, where is that

13 information?

14 DR. von LINDERN: That helps but it

15 makes me nervous.

16 DR. VANDENBERG: Hopefully you'll

17 be calm tomorrow.

18 DR. von LINDERN: I should say, I

19 was on the first CASAC in 1975, and I've been

20 on it all along. We used to see all of this

21 information developed up front. 

22 So the fact that I don't see the

Page 72

1 exposure-relevant information that's going to

2 be required to make eventual policy decisions,

3 is that something we didn't look at

4 intentionally in this document because

5 somebody else is going to look at it later? 

6 Is that the case?

7 DR. VANDENBERG: Could you repeat

8 that? That last part?

9 DR. von LINDERN: We don't see the

10 information that used to be developed in the

11 Air Quality Criteria documents with respect to

12 exposure, with respect to lead in commerce,

13 with respect to use, with respect to lifecycle

14 in the country, all of those factors that get

15 developed into developing rational policy. 

16 All of which seem to be unknown and much of

17 which would be relevant to Dr. Hopke's

18 question. 

19 How much lead is used in the U.S.,

20 where's it going and what are the policy

21 implications that the agency will make that

22 will influence that? We don't seem to know

Page 73

1 anything about that according to this ISA. 

2 Is that because we haven't looked? 

3 Is it because there is no data? Or is OAQPS

4 going to look later?

5 DR. VANDENBERG: Well, again to

6 clarify, as you look to the discussion

7 tomorrow about the risk and exposure plan,

8 what you'll see is the development of

9 information that is the companion to this, the

10 Integrated Science Assessment, again leading

11 to the policy assessment document. 

12 So I don't know, we've got folks

13 and they're all shaking their heads yes,

14 that's right, over there. So I don't know if

15 anybody else wants to comment. 

16 We do have our --

17 DR. FREY: Well, I think John maybe

18 is, I understand the question. It's a

19 question about the scope of the ISA and was

20 there a decision to not, I guess, do more on

21 quantifying the sources of lead and the

22 exposures related to lead as part of the ISA. 
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1 And if that's the case then I guess

2 I think what I'm hearing you say is the

3 implications, it's assumed that will be

4 addressed in the REA. 

5 DR. VANDENBERG: And the policy

6 assessments.

7 DR. FREY: So I guess clarifying --

8 DR. VANDENBERG: Yes, so that when

9 we develop the plan, the plan for this entire 

10 set of documents and analyses that was kind of

11 what we're doing, is we're laying out the

12 pieces and the plan to that. 

13 So I see Dierdre would like to

14 comment as well. If I might get Dierdre to

15 comment, Dr. Frey?

16 DR. FREY: Sure, yes.

17 DR. VANDENBERG: Dierdre, go ahead. 

18 There's a microphone over there.

19 DR. MURPHY: I'm Dierdre Murphy

20 with the Office of Air Quality Planning and

21 Standards, the lead on the review for that

22 office. 

Page 75

1 And I just wanted to say that of

2 course there is an exposure section to the ISA

3 which does include discussion of emissions and

4 the current air monitoring information. 

5 So I think there is actually, my

6 sense of course is that there is an intent

7 that the ISA does tee up the information we

8 have with regard to emissions of lead in the

9 U.S. with regard to air concentrations that we

10 currently have accessible to us in the U.S. as

11 well as the literature. 

12 What is in the literature in terms

13 of published studies on exposures, and the ISA

14 makes a point of saying that they're

15 considering exposures not just from air lead

16 because sometimes that's hard to tease out of

17 some of the studies, but that is described in

18 the ISA. 

19 And so that information is all of

20 what we consider in terms of us in the Air

21 office in thinking about what usefulness would

22 come from doing quantitative analyses, which

Page 76

1 is part of the discussion for tomorrow in

2 terms of potential for doing updates to

3 exposure assessments and risk assessments, and

4 then all of it of course gets considered in

5 the policy assessment. So hopefully that's

6 useful.

7 DR. FREY: Yes, I wonder if some of

8 this could be deferred to when we talk about

9 Chapter 3, because that chapter does address

10 at least nominally some of the issues of the

11 sources and the concentrations. 

12 But yes, Dr. Allen?

13 DR. ALLEN: If you want, it's on

14 that topic. I'll hold it if you want me to or

15 ask it now, your choice.

16 DR. FREY: I'll defer to you

17 because I don't know what you're going to say.

18 DR. ALLEN: A lot of the

19 information is on general background

20 concentrations of lead in the air. 

21 And what about if I own a house

22 that is located right at the fence line at

Page 77

1 Teterboro Airport, God forbid, or if I own a

2 house in the Coeur d'Alene mining area? 

3 What are the dust exposures? What

4 are the ambient air lead exposures to those

5 smaller populations as opposed to what we see

6 in these more global assessments? Is that

7 being looked at and considered?

8 DR. FREY: Well, it sounds like

9 that's an REA question, but I guess to the

10 extent in say Chapter 4 that deals with

11 exposure that the scientific basis for that is

12 discussed adequately or not, and it's probably

13 something we could talk about today.

14 DR. ALLEN: I think those people

15 are getting a dose.

16 DR. FREY: So, you know, Chapter 3

17 deals with the source to concentration,

18 Chapter 4 includes exposure. So maybe we can

19 come back to some of these issues at that

20 point.

21 I think was there another comment

22 from this side of the room? Did I miss
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1 anybody? So any other discussions on Charge

2 Question 1?

3 Yes, Rich?

4 MR. POIROT: I just had a, this is

5 more of a question really where it asks to

6 comment on the HERO system. 

7 And one question was whether the

8 references cited in this current ISA are the

9 only lead-related references or whether the

10 HERO system would be intended to encompass all

11 of the references from previous CDs for lead,

12 for example, and whether they were organized,

13 you know, in a consistent way.

14 MS. WALSH: So certainly some of

15 those references from previous, like the other

16 Air Quality Criteria documents, you would find

17 some of those references there, and some of

18 those may also be cited in actually this

19 document. 

20 But on the lead landing page that

21 I had that screen shot of, is our attempt to

22 try to in a more systematic way organize the

Page 79

1 references that were, if you would, reviewed

2 for this Integrated Science Assessment,

3 because not all references reviewed were

4 actually cited in the document. 

5 So this is a part of our

6 transparency that's trying to show that we did

7 look at more than what was just actually cited

8 in the document. 

9 And in that landing page as opposed

10 to if you went and looked at ozone, for

11 instance, the one previously, it was not

12 organized in such a systematic way. 

13 So there you can look and see by

14 effects, by disciplines, those kinds of

15 things. And we're really interested in your

16 feedback on that. And if I didn't say that

17 when I gave my little presentation, we really,

18 really want your feedback. 

19 And one of the differences here for

20 CASAC, for ozone and now for lead is that you

21 actually have access to the manuscripts. So

22 if you click on that link you can actually see

Page 80

1 the paper that we cited and look at that

2 information. 

3 We provide that to this review

4 panel because we consider you in that partner

5 group as we develop and move forward with our

6 ISA. 

7 Clearly we can't provide that to

8 the public for copyright issues. That's the

9 difference. That's one of the primary

10 differences between HERONet and HERO. 

11 But you should be able to click on

12 that link and whereas in the screen shot it

13 had the number, you would just click on the

14 citation. We tried to get rid of that number

15 for lead. Again that was a new thing to lead

16 this time.

17 MR. POIROT: Yes, I mean it seems

18 like it's going to be a very useful system,

19 and some of your summary slides that you

20 showed earlier were kind of the first time I

21 had any idea that, you know, that was the

22 scope and the depth and breadth. 

Page 81

1 But anyway the idea though of

2 providing links to all the citations and

3 previous documents I think is going to become,

4 is important and becomes increasingly

5 important especially since these ISAs are

6 supposed to just tell what's new. 

7 And if we're trying to briefly

8 summarize what was the state of the scientific

9 understanding prior to the new ISA simply by

10 reflecting back to the previous one, if the

11 previous one was only what was new, it's kind

12 of a spiral that goes in the wrong direction.

13 So building in all of the

14 references upon which the basic level of

15 understanding of lead in the atmosphere and

16 its associated effects would I think be a good

17 idea.

18 MS. WALSH: That's a great comment. 

19 Thank you.

20 DR. FREY: Yes, Dr. Allen?

21 DR. ALLEN: One thing that was very

22 hard in the ISA was the fact that it jumped in
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1 at 2006 with not even a paragraph at the

2 beginning of the section to tell me what you

3 consider the important information to be prior

4 to that. In other words, you know, in the

5 previous documents. 

6 And what really would have been

7 exceedingly helpful to me would be to know or

8 to have a summary of where the position was

9 and why and therefore how this new information

10 really is new and useful to me. 

11 You know, it's a great literature

12 review overall, but it's so highly restricted

13 in it's timescope that I would have to take

14 the previous documents, cut them apart and

15 paste it all together to have an integrated

16 view.

17 DR. FREY: Okay, other comments on

18 Charge Question 1?

19 Dr. Kosnett, would you be able to

20 take a stab at summarizing what you've heard

21 as the consensus on this charge, or the key

22 points?

Page 83

1 DR. KOSNETT: Yes, I think there

2 were a lot of comments that weren't based on

3 the charge though.

4 DR. FREY: Sure, yes, and I think

5 that's true. So I think you can edit the

6 discussion to what was responding to the

7 Charge Question.

8 DR. KOSNETT: Well, I think most

9 people were happy with, I think there's

10 consensus. Most people were happy with the

11 discussion of the articles that were within

12 the order of magnitude. 

13 I respect Ian's comments about the

14 value of looking at those larger ones. But

15 Ian, maybe help me. Do you think those higher

16 studies will assist EPA in assessing a

17 potential revision of the National Ambient Air

18 Quality Standard?

19 DR. von LINDERN: I see my problem

20 is with the process, because I see that this

21 process confines the information that's going

22 to move forward as opposed to the former

Page 84

1 documents, which were inclusive of almost

2 everything that was known about lead out

3 there. 

4 Now it's down to, what's the new

5 stuff that was known about lead in the last

6 two years that might change our particular

7 policy decision that we made last time? I

8 have problems with that. 

9 I think a broader view should be

10 moving through the agency that the old

11 criteria documents used to reflect. 

12 And confining it to only U.S.

13 exposures only based on new information that's

14 coming from the peer review literature pretty

15 much predetermines that we're not going to do

16 anything about lead in the next two years

17 because there's not new information out there

18 to redo these analyses.

19 DR. KOSNETT: So you're saying as

20 a valuable scientific document that is useful

21 worldwide it's good to include studies that --

22 DR. von LINDERN: Certainly.

Page 85

1 DR. KOSNETT: But you're not

2 disagreeing that in terms of the way the

3 policy is focused on the question of the

4 ambient air quality standards in the United

5 States that those studies are helpful?

6 DR. von LINDERN: I can see that

7 this process moves forward to help EPA answer

8 this particular question. This process does

9 not replace the information that was formerly

10 provided in the old process to the agency to

11 conduct policy. And I don't know if that's

12 happening anywhere else in the agency or if

13 it's just being forgotten.

14 DR. FREY: Yes, I think though the

15 issues you raised are, in fact, constraints on

16 this process. 

17 That this is a process leading

18 toward a, informing the administrator on a

19 decision whether to retain or revise the

20 existing NAAQS, and if revising it inform

21 based on scientific information so that she

22 could take that into account in making a
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1 decision to revise. 

2 So the context is not a broader one

3 as you point out. I think that is just simply

4 a constraint of what our mandate is. Not sure

5 what else to say. 

6 I think Vanessa would like to add

7 something.

8 DR. VU: Well, previously the CASAC

9 has discussed about the scope and size of the

10 AQCD, the ambient criteria document. 

11 And CASAC has engaged with the

12 agency in revising the process to recommend

13 the agency to develop an ISA, and Integrated

14 Science Assessment, shorter document, more

15 synthesis of what we have new. 

16 Now I understand, I hear a lot of

17 comments about what's in the various chapters

18 on exposure and emission, et cetera.

19 As I think Dr. Frey has discussed,

20 you know, you can comments of the adequacy of

21 these chapters with intent of covering what is

22 the agency's plan to cover to inform the

Page 87

1 decisions with regard to ambient air quality

2 monitoring, standards. Ambient air quality

3 standards, sorry. Excuse me.

4 So the CASAC has agreed and support

5 the agency this process of develop ISA, the

6 risk and exposure assessment followed by the

7 policy assessment which used to be a staff

8 paper. 

9 So we went through all that and,

10 you know, just when we started this new

11 process with PM and then now with ozone, now

12 with lead, we all agreed to this process. 

13 So any scientific question you have

14 about the scope of the document and the

15 content is welcome, but I just want to make

16 sure that you all that process have been

17 engaged with CASAC and CASAC is pretty much is

18 support this process. 

19 So I'm just going to let John, you

20 know, clarify anything I didn't say

21 appropriately.

22 DR. VANDENBERG: No, I don't have

Page 88

1 anything to add. I think that's the point, is

2 that part of this planning process is to lay

3 out the pieces and actually to add more focus

4 and that's partly the EPA's desire. 

5 But also CASAC's comments in the

6 past have been to focus on the most policy7 relevant information, with that policy being

8 the information that'll support the decision

9 to retain or revise the standard. 

10 So I certainly respect the concern

11 that the former Air Quality Criteria documents

12 were more, perhaps viewed as more complete or

13 included other information, but that was also

14 viewed as somewhat of an impediment to the

15 overall goals of trying to be able to be a

16 focused timely manner.

17 DR. FREY: Yes, Dr. Wasserman?

18 DR. WASSERMAN: I just wonder

19 whether it perhaps wouldn't be helpful in this

20 document then to make that explicit and to

21 say, you know, there is a whole lot of

22 information about higher levels of exposure

Page 89

1 that may be important for the science of

2 understanding this, but that's really not what

3 -- see, I think there's a, we have a misnomer

4 here for calling this an Integrated Science

5 Assessment. 

6 It does seem as though it should be

7 the last word of everything you'd ever want to

8 know about lead. And if it can't be, and I

9 reflect that it, that's really maybe too

10 broad, then at least to parse it down and say,

11 we're going to focus here, and there is a

12 whole lot of other stuff we can't look at

13 there.

14 DR. FREY: Okay. Well, yes, that

15 may be a fairly easy thing for EPA to just

16 give a little context. 

17 You know, I'm not, I'm an engineer

18 so I'm not a health effects expert and I'm

19 just struggling with, you know, if there was

20 a recommendation from this panel to EPA to

21 look at studies at much higher exposure

22 levels, would that inform judgments about
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1 things like mode of action or other factors

2 that aren't informed by narrowing the focus to

3 within order of magnitude? 

4 I mean if there was some scientific

5 rationale that would be helpful elsewhere in

6 the document, you know, maybe that would be a

7 way of coaching that particular recommendation

8 if that's a recommendation the panel wants to

9 make. 

10 But I think what I heard is, you

11 know, that at least a few discussants were

12 pretty happy with the roughly order of

13 magnitude range of the study selection

14 criteria and that the main motivation for

15 looking at higher exposure levels was that

16 that had some relevance to situations perhaps

17 in other countries but may not be that useful

18 to the standard process here in the United

19 States as, you know, given where we are now. 

20 And if that's the case then I think

21 that's just information. In context probably

22 not that critical to the ISA. And I'm not the

Page 91

1 one who can make that judgment because I'm not

2 a health effects expert. 

3 I guess you want to address this

4 point?

5 DR. ROSS: Can I follow up on that?

6 DR. FREY: Yes.

7 DR. ROSS: One of the bases that

8 we've used for that sort of bounding for the

9 higher concentration studies has been and is

10 for other pollutants to is the -- I'm Mary

11 Ross. I'm the first level supervisor for this

12 group, sorry. Has been the concept that at

13 the higher concentrations you may have a

14 different mode of action. They may not be

15 exactly on the same path. 

16 So I would actually, that's

17 something we're seeking advice on from the

18 health experts is, does it make sense to focus

19 on the concentrations at tox studies that are

20 relevant to the epi study exposure levels, or

21 do the higher concentration studies inform

22 what's happening at lower concentrations too? 

Page 92

1 So that's a question we'd be

2 interested in your thoughts on.

3 DR. FREY: Dr. Goodrum?

4 DR. GOODRUM: Yes, I think Ian's

5 suggestion goes beyond, you know, the

6 consideration of studies that evaluated high

7 level exposure from the point of view of high

8 blood leads. 

9 I think the recommendation is more

10 of a can we continue the knowledge base that

11 we have through our successive documents in a

12 way that allows us to address more

13 specifically some of the questions that we

14 have currently? I think we all recognize that

15 teasing out air as a contributor to multiple

16 exposure pathway risk assessment is pretty

17 challenging. 

18 I think understanding source

19 contributions and maintaining some synopsis of

20 what those data are and how those change over

21 time can be helpful. I would find that

22 helpful. 

Page 93

1 And I think one thing that I'm

2 hearing is that this document is large already

3 and we only have limited time and resources to

4 continue to synthesize information. I guess

5 I would just encourage consideration of moving

6 further towards, you know, electronic

7 repositories. 

8 And I'll just give the ITRC as one

9 example, the Interstate Technical Regulatory

10 Council, which develops technical regulatory

11 guidance documents. And they are moving

12 towards electronic postings of those documents

13 with hyperlinks between sections, moving away

14 from paper documents. 

15 So I think, you know, especially

16 with the HERO platform and EPA's move to

17 provide more information electronically, that

18 I think we have an opportunity to listen

19 pretty closely with Ian's suggestion as to

20 carry forward some of the information from

21 previous assessments. I'd like to just make

22 that suggestion.
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1 DR. FREY: Okay, let me maybe

2 reflect a little bit on what we've discussed. 

3 I think by and large that my impression that

4 the panel is more or less happy with the one

5 order of magnitude selection criteria.

6 However, I think we can revisit

7 this through the day. I think as we go

8 through the other charge questions to the

9 extent that issues come up where it would make

10 sense to look at studies beyond that criteria

11 that we could modify, you know, this position

12 on Charge Question 1. 

13 It seems like informing that

14 further would really be contingent on what

15 we're going to say for some of the other

16 charge questions. So I guess my thought right

17 now is we may have said about all we can say

18 right now on Charge Question 1. 

19 We can revisit it toward the end of

20 the day if it seems like we've learned

21 something from the discussion that would bring

22 us beyond what seems like, you know, the

Page 95

1 general comfort level with the plus or minus

2 order of magnitude. 

3 Seems like there were positive

4 comments on HERO. There were even comments

5 toward going to more computerized hyperlink

6 documents rather than paper documents. 

7 And anything else significant we

8 might want to say on Charge Question 1 at this

9 point?

10 If not, I would propose we go ahead

11 and take our break now. And we were

12 originally going to have a 15-minute break so

13 we'll go ahead and do that. That means we

14 come back at 10:50, and we will then start on

15 Charge Question 3.

16 (Whereupon, the foregoing matter

17 went off the record at 10:37 a.m.

18 and resumed at 10:51 a.m.)

19 DR. FREY: We're going to

20 reconvene. We're now 15 seconds behind

21 schedule. 

22 All right. Our next order of

Page 96

1 business is discussion of Charge Question 3,

2 and our discussants include George Allen, Rich

3 Poirot, Cliff Davidson, Phil Hopke and Chris

4 Johnson, and we'll begin with George Allen.

5 MR. ALLEN: Thanks, Chris. Some

6 general comments that the document is well

7 written, it's certainly comprehensive and very

8 detailed. 

9 But as was recently discussed with

10 the ozone ISA, it may be too comprehensive in

11 some areas, and at a thousand some-odd pages

12 might benefit from some edits to reduce the

13 overall length and improve the focus and

14 specifically on Chapter 3. These comments are

15 addressed in that context and may also apply

16 elsewhere, I don't know.

17 DR. FREY: George, could you maybe

18 move a little closer to the mic?

19 MR. ALLEN: Well, okay. I can be

20 loud, although I seem to have a -- oh, okay.

21 Let's see, where was I? It's tough

22 to say where to cut. That's a question we'll

Page 97

1 probably revisit. But I think it's probably,

2 to make it a little bit better read, the

3 length right now is excessive.

4 Moving on from that topic, those of

5 you who know me and what I do probably know

6 what's coming next. A notable omission in

7 Section 3.4.1 is, there's no discussion of

8 current work currently being done by EPA at

9 ORD, but a different part of ORD, to develop

10 a better, not a better HiVol, a better big

11 part of an uber-coarse sampler like greater

12 than PM10 but something that's more robust

13 than the HiVol. 

14 The section does discuss the

15 limitations of the current FRM HiVol sampler,

16 which dates back to the '40s. It's getting

17 quite old with essentially no changes.

18 But the section doesn't suggest

19 anything better other than PM10, which that

20 discussion occurred in the last round of the

21 lead NAAQS review, and we stayed with the

22 HiVol as the FRM because there wasn't anything
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1 waiting in the wings to take its place.

2 I hope we don't go down that same

3 path this time that when we get to that point

4 that ORD will have characterized some thing,

5 and there is some thing in mind that would

6 with some discussion obviously hopefully be

7 acceptable to this panel as a replacement for

8 the HiVol as the lead FRM sampler.

9 DR. RICHMOND-BRYANT: I'm sorry, I

10 just want to make a quick comment just to

11 maintain the context of the ISA. 

12 I agree that all of the things that

13 you're mentioning are very important

14 developments in the future, but we're somewhat

15 limited in our scope to review what is in the

16 peer review literature, what is in the public

17 domain of the things that are available and

18 what their limitations as well as benefits

19 are. 

20 So while those are important

21 developments, it was just somewhat outside of

22 the scope of the work that we present for the

Page 99

1 ISA. So just to kind of keep that in context

2 that we're limited to review what's in the

3 peer review literature. Thank you.

4 MR. ALLEN: Yes, there is limited

5 literature on this issue about using other

6 inlets that exist that could be referenced. 

7 I could make a point or two that --

8 DR. RICHMOND-BRYANT: That would be

9 terrific.

10 MR. ALLEN: -- actually I think I

11 did in our previous meeting a few months ago.

12 All right, I won't go on to that,

13 but at what point in the process would that be

14 appropriate to raise? If not in the ISA,

15 would it be in the policy assessment document

16 or --

17 DR. RICHMOND-BRYANT: My colleagues

18 in OAQPS may speak more succinctly to that,

19 but there is a separate monitoring of

20 implementation process that goes on. So that

21 might be a more appropriate venue.

22 MR. ALLEN: Implementation not in

Page 100

1 the context of post-NAAQS but in the NAAQS

2 review process?

3 DR. RICHMOND-BRYANT: I'm sorry. 

4 Could you repeat that?

5 MR. ALLEN: Implementation I

6 usually think of as after the NAAQS has been

7 issued, but are you talking that

8 implementation or some other implementation

9 that's within the NAAQS process?

10 DR. RICHMOND-BRYANT: It's outside

11 of the ISA review. Later on in the process

12 there might be separate deliberations over how

13 the monitoring to show compliance with the

14 NAAQS is implemented and that's just outside

15 of what we do for the ISA.

16 DR. FREY: Yes, I guess I'd like to

17 just bring us back to the panel discussion. 

18 And I think questions about the

19 scientific merit of high volume sampling

20 versus scientific merit of others seem

21 appropriate, but I guess I'd like to go ahead

22 and continue with Mr. Allen's comments.

Page 101

1 I think the question of how to

2 interpret that for revision of the ISA to the

3 second draft is something that, you know, you

4 can consider in receiving the comments, but I

5 think this is an issue that's come up time and

6 time again. 

7 And, you know, the panel has some

8 expertise I think to provide some information

9 that could expand the literature search, maybe

10 the scientific basis for it in the context of

11 the ISA.

12 But this also would translate that

13 into, well, it certainly would have

14 implications for I think the policy assessment

15 and something that the panel probably would

16 need feedback from EPA as we go forward on,

17 you know, what if anything the agency can do.

18 And I think we've seen this with

19 other NAAQS reviews where there's questions

20 about the monitoring network and how that ties

21 into evolution of the monitoring network.

22 So I think rather than having a
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1 meta-level discussion about whether or not to

2 talk about it, let's just go ahead and hear

3 the comment and then we'll deal with it as

4 appropriate.

5 MR. ALLEN: Okay. You know, my

6 biggest concern is at some point during this

7 process, not after it because the FRM is part

8 of the NAAQS, when they issue the NAAQS they

9 say, this is the method, I want to make sure

10 that this does get addressed. You know,

11 that'll come up later in the comments.

12 But moving on from that, another

13 area of concern that isn't really addressed by

14 the ISA is discussion of lead in both wildfire

15 and residential space heating related wood

16 smoke. 

17 There certainly is lead in wood

18 smoke just as there's sulphate and mercury. 

19 And we have valley towns where wood smoke

20 concentrations really can be quite high

21 periodically during the winter. This is

22 probably their primary air exposure pathway

Page 103

1 for new lead. 

2 On Page 3-102, it does note that

3 fine lead is fairly soluble. I don't know to

4 what extent that's true for wood smoke lead,

5 but that's why you'd expect it in general to

6 be present in the wood in uptake by the tree

7 or possibly through the leaves. 

8 A few specific comments, Section 3-

9 2, Pages 14, Lines 14, 16, about the 2008 NEI

10 Lead Inventory Reports, general aviation

11 aircraft is about half of all lead emissions.

12 But the question here I think is

13 the question, how much of that is relative to

14 human exposure? And it's probably a lot less

15 since most of these emissions are at altitude

16 and their in the fine mode and they may

17 deposit as wet deposition mercury or they may

18 deposit outside the U.S.

19 So I'd like to see that comment

20 refined, because as it stands right now it's

21 to me a somewhat misleading or unclear. It's

22 a stunning number and it's technically

Page 104

1 probably true, but I don't think it reflects

2 the relevant exposure, human exposure. It's

3 certainly not air pathways.

4 I do, as a footnote, fully support

5 phase out of lead in avgas, but I'm not

6 convinced that avgas lead is a significant

7 human exposure at least in the context of the

8 current NAAQS or this NAAQS review.

9 Of Section 3.4, Lines 8 and 15 and

10 16, where it talks about the Herculaneum

11 primary lead smelter in Missouri which is the

12 largest single point lead source in the

13 country, it may or may not be worth noting and

14 it may or may not be new information to EPA or

15 this part of EPA I should say that that source

16 is closing by the end of 2013.

17 There is a consent order and it's

18 driven primarily by SO2 but also by lead, and

19 that's sooner than the binding 2016 date. 

20 They went ahead and decided, we've had enough.

21 And I want to stress here that this

22 closing would really present an incredibly

Page 105

1 rare opportunity to study the changes in soil

2 lead as well as the effects potentially on

3 vegetation. 

4 Over time you're going to turn that

5 switch and that source is going to go off. 

6 And there's a lot of uncertainty as to what

7 happens to lead in the soil that's discussed

8 in this chapter. A lot of pages are devoted

9 to that.

10 So this is a rare opportunity to

11 learn more, although it certainly cites

12 specific and soil varies widely from place to

13 place, but I don't think you'll ever have a

14 chance like this to do a longer term study

15 after you throw that switch. 

16 So it's not really an

17 accountability study, but it certainly would

18 be a study of opportunity. And I would

19 encourage EPA, not necessarily ORD but EPA as

20 a whole, to develop funding for an extramural

21 study or perhaps studies maybe through the

22 STAR program, and to start before the smelter
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1 shuts down for a number of reasons. 

2 Because there will be clean-up

3 efforts and so on and so forth but if you get

4 in there after the fact -- you really want to

5 start, people, because this is a major

6 opportunity to really advance our knowledge of

7 lead in the soil and what happens to it. 

8 Its fate, essentially, how long

9 does it persist? And that question comes up

10 later in the REA as one of the uncertainties.

11 Some other near road sources. I

12 don't think it's noted in the ISA what that

13 lead wheel weights have been banned in seven

14 states or more. And my understanding, and I

15 may be wrong on this, but EPA is planning an

16 NPRM next year in 2012 to ban them on a

17 national scale.

18 I would need to confirm that, but

19 that was what I got from poking around. And

20 that's probably worth mentioning, because

21 certainly they're one of the largest sources

22 of near roadway lead currently out there. And

Page 107

1 once they're banned, their use will drop very

2 rapidly and again things, that's a very big

3 change.

4 Also especially in the post-lead

5 wheel weight era, which is potentially coming

6 soon, I found very little quantitative

7 information about lead in tires. It is there,

8 but I couldn't find any clear literature that

9 said, you know, so many -- it's not large, but

10 there's a lot of tire dust. 

11 (Off microphone discussion)

12 MR. ALLEN: Yes, but it would be,

13 obviously be in the coarse or uber-coarse mode

14 but, and I'm not talking about bologna skins

15 here, I'm talking about tire particles that

16 get re-enchained and blown off to the side of

17 the road.

18 So in the absence of lead wheel

19 weights that might be, even though it's small

20 there's a massive tonnage of tire wear on the

21 road, so it might be the next important thing

22 as you drill down and get rid of the more

Page 108

1 obvious solid chunks of lead on the roadway.

2 This comes up also in, that was in

3 3.2.5. It also comes up again or perhaps

4 should come up again in Page 3-69, Lines 8 to

5 14. So that's a topic there.

6 I believe those are the major

7 points that I want to make, and at this point

8 pass it back to Chris. Thank you.

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

10 George. Rich?

11 MR. POIROT: Thanks. I agree with

12 nearly all the points George raised. The

13 first part of the charge question had to do

14 with, to what extent are the atmospheric

15 science and air quality analyses presented in

16 Chapter 3 clearly conveyed and appropriately

17 characterized? 

18 And this is sort of a very general

19 commentary on the process, but I kind of

20 wanted to follow up on something that Herb

21 Allen mentioned earlier in the context I think

22 of the Chapter 1.

Page 109

1 It's very difficult I think to just

2 tell the story about what's new since the last

3 review cycle. It's impossible really without

4 first stating what has been the current state

5 of the scientific understanding up to this

6 point.

7 And I know and Vanessa's talked

8 about how well we've decided that we should

9 focus on what's new, but I think it's really

10 more a matter of degree. 

11 It wouldn't take that much to

12 provide a clear summary statement in each

13 section. This is the current state of the

14 scientific understanding as has been

15 identified in previous review cycles. 

16 A summarization, and then talk

17 about what's new, and that gives you a better

18 way to put those new papers in context. Are

19 they really relevant? Do they change the way

20 we're thinking about anything?

21 So I think to me that was

22 especially notable in parts of Chapter 3 where
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1 the authors stuck in some cases very strictly

2 to the assignment of just tell what's new

3 almost to a fault where, you know, most of

4 what we know is actually what's old and what

5 we knew before five years ago. 

6 And this is going to become more

7 important as these ISAs cycle through more

8 rapidly. If we define the state of the

9 previous understanding as what was stated in

10 the previous ISA, and if that itself is only

11 a five-year update then we're going to be in

12 trouble. 

13 So anyway that was just something

14 that I think in certain sections of the

15 chapter, jumped out at me, and I'm not a fan

16 of the only what's new approach.

17 The second part of the charge

18 question related to the information regarding 

19 lead source characteristics, fate and

20 transport of lead, lead monitoring, spatial, 

21 temporal patterns of lead concentrations in

22 the air and non-air media, are they accurate,

Page 111

1 complete and relevant to the review of the

2 NAAQS. 

3 I agree with George that this was

4 a very thorough discussion within the

5 constraints of, you know, emphasizing what's

6 new. And so I thought that was all rather

7 well done. 

8 There to me are some lingering

9 issues with emissions inventory. During the

10 last lead review cycle, the inventory changed

11 during the course of that review process such

12 that the largest source categories flip13 flopped back and forth. 

14 So at any rate, there seemed to be

15 some inconsistencies particularly in the, what

16 fraction of the total is emitted by aviation

17 fuel. From the last review was apparently

18 less than ten percent of the total, to now

19 it's half the total. 

20 Well, is that because everything

21 else has been reduced so substantially within

22 that recent, that five-year period? Or is it

Page 112

1 because of just differences in the inventory

2 methodologies, which I suspect probably some

3 of the latter was contributing. 

4 And just to make that clear would

5 be useful rather than simply presenting the

6 numbers from the previous assessment, in this

7 one and showing how they differ.

8 One of the things that I think is

9 especially difficult to do in many cases is to

10 really relate the concentrations of lead in

11 all these different and other environmental

12 media to concentrations of lead in the ambient

13 air. 

14 And I don't think that's the fault

15 of the reviewer, of the authors. I think

16 largely the literature often doesn't really

17 make those connections in a way that we can

18 say yes, the concentrations of lead in soil

19 are expected to change with this slope as a

20 function of changes of lead concentrations in

21 the air. So that's an inherently weak point,

22 but I think you've done about as well as you

Page 113

1 could have.

2 Let's see, I guess my one major

3 point that I wanted to raise has to do with

4 some of the information mostly presented in

5 the appendix to the chapter, which generally

6 was quite helpful and very detailed, showing

7 the difference of lead concentrations and

8 different particle size measurements from co9 located measurements of lead in TSP, PM10 and

10 PM2.5.

11 And one thing I wanted to comment

12 there on is that in the previous lead review

13 cycle a similar kind of a comparison was made

14 especially between lead in PM10 and TSP, in a

15 memo by Mark Schmidt and Kevin Cavender, which

16 included many of the same comparative sites

17 and datasets that were finished then and

18 haven't been expanded now as have been

19 included in the current analysis.

20 And some of the answers were

21 different in the current appendix than they

22 were in that previous memo. It just kind of,
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1 I don't know why I even thought to check that. 

2 It's just that some of the numbers surprised

3 me and then looking back I saw that they were

4 different.

5 Part of that difference I think is

6 due to you used a different correlation metric

7 this time around, is Spearman's rho I think,

8 whereas they had used an r-squared. 

9 But I guess I expected, maybe we've

10 got good statisticians in the room, I expected

11 the r-squared to be a more stringent number.

12 PARTICIPANT: We won't comment on

13 that.

14 MR. POIROT: And then the other one

15 was the average ratio of the lead in the

16 different size samples, PM10 to TSP lead. 

17 That metric appears to be the same in the two

18 analyses, but the answers are different in

19 many cases.

20 So just raises a something to

21 double check. I'm sure there's an explanation 

22 that I'd be curious to know, you know, maybe

Page 115

1 the method was a little different or something

2 along those lines.

3 But here's the main point and then

4 I'll shut up. To me there was a very

5 disturbing member of totally illogical results

6 in this comparison. Almost 20 percent of the

7 sites comparing PM10 lead to TSP lead found

8 more PM10 lead than TSP lead. 

9 And somewhat more disturbing,

10 almost 20 percent of the sites comparing PM2.5

11 lead to TSP lead found more PM2.5 lead than

12 TSP lead. And almost 40 percent of the sites

13 comparing 2.5 lead to 10 lead found more 2.5

14 lead than 10 lead. 

15 Rather than illuminating our

16 knowledge of what's the size distribution of

17 lead, this is telling me we've got some really

18 bad quality lead measurement data out there. 

19 And it really kind of surprised me. I thought

20 we knew how to do this better, but I guess we

21 don't.

22 PARTICIPANT: But we do. They just

Page 116

1 didn't do it right.

2 MR. POIROT: And Phil will add to

3 this in a minute. So it made me want to ask

4 at least for some additional information when

5 you make these comparisons of the different

6 sampling and analytical and extraction methods

7 that are typically used for these different

8 programs. 

9 I know there's a wide variety out

10 there but, for example, most of the PM2.5 lead

11 is going to probably be XRF data.

12 (Off microphone discussion)

13 MR. POIROT: Oh, okay. And so

14 those methods would be useful along with, now

15 I'm wanting to see a lot more of the accuracy

16 and precision data from the different

17 measurements. I think that would be helpful.

18 So that was the one major thing

19 that jumped out at me that I thought deserved

20 comment. All the rest of my comments are all

21 fairly minor points.

22 DR. FREY: Okay. Thank you, Rich. 

Page 117

1 John, you want to clarify?

2 DR. VANDENBERG: Yes, just a point

3 on that last point that you made. I think

4 it's a very good point about the

5 identification of the methods that we're

6 using, and that may help clarify that.

7 Jenn, did you have a comment?

8 DR. RICHMOND-BRYANT: I just wanted

9 to say after that, because I saw Mr. Curtis'

10 comments as well as a few of the other

11 panelists, and that issue came up in

12 particular a couple of times. 

13 So a couple things we'll be doing

14 are, as you point out, to clarify the accuracy

15 and precision of the data and where possible

16 to clarify the methodology by which it was

17 obtained. 

18 But we also dug back into the data

19 and found that several of those sites where

20 there were higher ratios had data below the

21 method detection limit. 

22 And so I think we're going to be
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1 probably casting a different filter before we

2 present those data so that we're a little bit

3 more targeted in what we present next time. 

4 So we will certainly state clearly how we

5 choose to present what we do.

6 But we'll also be a lot more careful in the

7 next review of presenting data that are below

8 the method detection limit, because you're in

9 the white noise range where some of those

10 ratios were presented and were very high.

11 Thank you.

12 DR. FREY: Okay, next is Dr. Cliff

13 Davidson.

14 DR. DAVIDSON: Thanks, Chris.

15 So I had a few comments that were along the

16 lines of what we just heard from George Allen

17 and Rich Poirot and I won't, therefore, go in

18 to those.

19 Let me mention a couple of other

20 things. One is, there is a section on

21 deposited lead near roadways.

22 This is at 3.2.2.6, and there's a

Page 119

1 discussion there of the only study in the

2 literature that tried to quantify how much

3 airborne lead is from resuspended soil that

4 was contaminated from all those decades of

5 leaded gasoline use.

6 And the paper used a mass balance

7 method and came up with the conclusion that

8 the lion's share of the airborne lead is --

9 this is in Los Angeles and this was back in I

10 think 2001 is when the data were used, 2001,

11 2002.

12 The lion's share of that airborne

13 lead is from resuspended soil, and the number

14 given was around 90 percent but that was just

15 a rough estimate.

16 The ISA basically says that this

17 number was not valid and cites -- yes, that's

18 actually the paragraph I'm talking about. 

19 Says that that number, 90 percent, was not

20 valid and therefore will not be used in the

21 current assessment.

22 And I just wanted to make the point

Page 120

1 that that's only a rough estimate, and rather

2 than making a statement that the paper isn't

3 valid, it might be better just to say this is

4 a rough estimate and the results suggest that

5 resuspended lead near the roadside could be

6 very important.

7 I think that would be a better way

8 to handle it because, unfortunately, this is

9 the only study in the literature that attempts

10 to do this.

11 I'll mention just one other point,

12 is that throughout the chapter there are

13 several places where dry deposition is viewed

14 as kind of an ultimate sink for lead.

15 That once the lead dry deposits

16 it's essentially out of the atmosphere and

17 therefore it, you know, it may get on food

18 that people eat or perhaps children will

19 ingest it because of hand to mouth activities

20 and so forth.

21 But essentially that's viewed as a

22 sink where exposure can happen a different

Page 121

1 way. And I think the truth of the matter is

2 that a lot of the lead that dry deposits

3 subsequently gets resuspended and then it

4 deposits again and then it gets resuspended

5 again.

6 And so I think rather than viewing

7 lead depositing as an ultimate sink, I think

8 it might be better to view that lead as moving

9 through a complex system in different forms.

10 And therefore it could be subject

11 to causing exposure from the air subsequently

12 or from being deposited on the surface.

13 So okay, those are my only

14 comments. There are a few more issues that

15 are in my written report but they're fairly

16 minor.

17 DR. FREY: Okay, thank you, Cliff.

18 Phil Hopke?

19 DR. HOPKE: Okay, several things. 

20 I'd like to echo George's comment that this

21 looks much more like a criteria document than

22 ISA.
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1 I think with some judicious use of

2 appendices one could substantially reduce the

3 volume of Chapter 3 and make it much more

4 readable in terms of really providing an

5 integrated synthesis of the information rather

6 than again as comprehensive a review as -- you

7 know, again it harkened me back to the good

8 old days of criteria documents and I had hoped

9 we were past that.

10 Second, you comment about long

11 range transport of lead bearing particles, but

12 there's no effort to actually analyze the data

13 that are available.

14 There are data available and there

15 are reports particularly Liu et al., in JGR in

16 2003 or '04, I give the reference, in which,

17 you know, there is an effort to extract an

18 Asian dust signature from Lassen volcano and

19 Crater Lake National Parks.

20 And there's no indication that that

21 signature is enriched in lead. It was

22 certainly enriched in sulphur, but not

Page 123

1 enriched in lead.

2 And so I think we need to be

3 careful, and I'll raise the three most dreaded

4 words in this whole discussion, Policy

5 Relevant Background.

6 If we're going to start getting

7 into Policy Relevant Background, which is

8 really what you're laying the basis for here,

9 you really need to have somebody take a look

10 at those improved sites along the mountain

11 ranges in the West and really see whether

12 there's a basis for saying that there is a

13 significant increment of additional lead

14 coming with respect to the Asian dust

15 transport that's coming from the Pacific Rim.

16 I'm having problems with my

17 computer so I can't actually read my comments,

18 but I was rather appalled to see the use of

19 the Spearman ranked correlation.

20 I don't see how that informs

21 anything in this case and, in fact, simply

22 having things line up in the same order really

Page 124

1 doesn't tell us a lot about this kind of data.

2 And so Pearson correlation is

3 really the approach you should be using, and

4 if all you're trying to do is jack up the

5 apparent correlation coefficients by using

6 Spearman, that's really providing a false

7 representation of what's going on.

8 It was my impression that much of

9 that PM lead data was XRF, and I'm still very

10 concerned about the fact that PM10 and TSP

11 data are probably not being particle size

12 corrected.

13 And in both cases, and particularly

14 with TSP, you have attenuation by the

15 collected particulate matter that's going to

16 lead to substantial underestimates of the lead

17 in the more coarse fractions, because the

18 penetrability of the induced x-ray is small

19 compared to the range in the collected

20 particulate matter.

21 And so I think again there needs to

22 be very careful scrutiny and judicious choice

Page 125

1 of those data that are analyzed by methods

2 other than XRF in order to start informing us

3 appropriately of the PM10 to 2.5, TSP to 2.5

4 ratios.

5 I mean we really need to decide

6 whether we really need TSP or not. Even with

7 the new TSP heads that are available out

8 there, they're not well characterized.

9 They have not been wind tunnel

10 tested particularly. They are at least wind

11 speed or wind direction independent, but I'm

12 not sure that they're wind speed independent. 

13 That's, be very unlikely given the design.

14 And there still is going to be an

15 effective cutoff just as there is an effective

16 cutoff for TSP.

17 So, you know, one of the key

18 questions and something that I think you ought

19 to at least explicitly address, is the

20 question of the industrial hygiene definition

21 of inhalable particulate matter.

22 If what we're really interested in
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1 is accumulation of lead in the nasal cavity

2 and then uptake into the GI tract, it's

3 inhalable particles and that inhalable

4 particle curve that maybe we should be trying

5 to mimic in the sampler.

6 And there needs to be at least some

7 discussion somewhere in this document of, you

8 know, inhalable versus respirable versus et

9 cetera, because I think we're not really

10 adequately addressing the question of why we

11 want to look at TSP versus PM10 and get at

12 where our appropriate ultimate exposure metric

13 needs to be when we come up with an indicator

14 for a NAAQS.

15 DR. FREY: Okay. Thank you, Phil.

16 Dr. Chris Johnson?

17 DR. JOHNSON: Okay, thank you. I

18 thought the chapter was generally pretty well

19 written. I have some similar concerns about

20 its length. But a couple general comments.

21 On the atmospheric side, the data

22 for the lead concentrations in air came from

Page 127

1 four different networks which were set up for

2 different purposes.

3 And at least as far as I could

4 tell, none of them are particularly well

5 suited for the assessment of whether existing

6 or future NAAQS for lead is attained.

7 So if not in this assessment,

8 perhaps by the time of the next NAAQS review

9 it would be useful to have some kind of a

10 network that was capable of assessing whether

11 or not this attainment was occurring.

12 George and Phil and Rich have all

13 talked a little bit about the particulate

14 matter data, and it sounds like there's going

15 to be an attempt to try to work with those

16 data to understand it better.

17 The section that follows that

18 section is a literature review of studies in

19 which you've tried to look at these particle

20 size distributions. You know, there are

21 plenty of studies in that section.

22 Maybe it's best to leave this

Page 128

1 particular analysis out and just rely on the

2 literature for that part of the assessment.

3 The sections talking about

4 different spatial and temporal patterns of

5 lead in various environmental media I thought

6 were, well, I wondered if they were as

7 complete as they could be.

8 In the case of the soil studies,

9 the section on soil studies had some very

10 interesting material on urban and suburban

11 soils, smelter impacted soils, soils affected

12 by lead shot.

13 There weren't any studies cited of

14 more pristine environments like forest soils. 

15 There are a couple of studies which I put in

16 my comments that might be discussed there.

17 The section on lead in rain, the

18 only information cited there are from a couple

19 of studies in Canada and Europe on temporal

20 patterns in lead and rain, which just made me

21 wonder.

22 Is there no one in the United

Page 129

1 States that's monitoring lead in rainfall

2 somewhere? And if there are people who are

3 monitoring lead in rainfall it would seem that

4 that data, some of those data might be in here

5 now.

6 The document does try to look at

7 studies that have been published since 2005,

8 and so maybe there haven't been things

9 published. But still it seemed to be a pretty

10 important omission.

11 And then also the section on

12 natural waters. Actually it only talks about

13 one study, one paper, which is a study from

14 Ontario, in Canada. And again it made me

15 wonder, is no one doing any monitoring on lead

16 in lakes and streams in the United States?

17 It seemed to be that there ought to

18 be some information out there on temporal, if

19 not spatial patterns because there's not a lot

20 of studies, at least temporal patterns and

21 concentrations in some natural waters.

22 One of the charge questions says,
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1 does the ISA adequately characterize the

2 available evidence on the relationship between

3 ambient air and lead in various environmental

4 media?

5 As I think Rich maybe -- I can't

6 remember -- mentioned, it's a tough question. 

7 I mean it's tough.

8 I work a lot with soils, for

9 example, and it's, you know, it's tough to

10 imagine how you would relate ambient air to

11 soil, lead in ambient air to lead in soil, and

12 whether those relationships, even if they

13 existed, would be useful for prediction and

14 that sort of thing.

15 But, you know, having said that

16 there isn't a lot of information in here about

17 relationships between lead in ambient air and

18 lead in water, lead in rain. Lead in rain,

19 you'd think you could be able to that, lead in

20 soil, et cetera.

21 I guess a couple more comments. 

22 The talk about lead solubility in the

Page 131

1 atmosphere in particular, one thing that, you

2 know, is also true. It's a good news story. 

3 Acid rain especially in the Northeast and

4 Midwest is going down, down, down.

5 And, you know, you would think that

6 with the pH of moisture and precipitation in

7 the atmosphere increasing that would affect

8 the solubility of lead and therefore might

9 affect deposition through a pH effect.

10 I don't know if people have studied

11 that but it certainly could be modeled and

12 that could make a difference in terms of the

13 lead deposition.

14 And I guess I'll finish with a

15 comment on Figure 3-19. I don't know if we

16 can get that up on the screen. That's on Page

17 374.

18 This is a section in which the

19 document tries to look at seasonal variations

20 in lead TSP, and the document says that -- see

21 if I can find it here.

22 The document says that "the average

Page 132

1 of lead concentrations over all monitoring

2 sites is higher in fall and lower in winter

3 than in other seasons."

4 (Off microphone discussion)

5 DR. JOHNSON: Thank you very much,

6 by the way. There you go.

7 So the text says that the average

8 lead concentrations are higher in fall, lower

9 in winter than in other seasons.

10 Box plots are hard to, I mean

11 they're hard to interpret for patterns and

12 what not, but it seems to me like spring is

13 highest, maybe fall is next and then winter

14 and then summer, at least looking at the stars

15 on there.

16 But in any event, whatever the

17 pattern is, were there any statistical

18 analysis used to try to verify or to get a

19 level of confidence in a conclusion based on

20 this study and then looking at this seasonal

21 pattern and the data?

22 Maybe they were referring to other

Page 133

1 figures, I don't know. But the other figures

2 at least at a glance that followed this also

3 seem to show similar patterns or non-patterns.

4 Anyway I think that, I also have a

5 number of comments that the group can look at

6 but I think that's all I really want to say

7 here. Thanks.

8 DR. FREY: Okay, thank you.

9 I'd like to I guess ask George and

10 Rich if they could reflect on -- or I guess

11 actually before I do that I should ask, I

12 should invite the other panel members to make

13 comments.

14 So are there comments from other

15 panel members on Charge Question 3? Yes, go

16 ahead.

17 DR. GOODRUM: Just one discussion

18 point. I think Dr. Hopke mentioned his

19 reservations about switching from Pearson to

20 Spearman.

21 And just have to say that I'm a big

22 fan of Spearman rank and Kendall tau, the
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1 other non-parametric methods, because they're

2 less sensitive to outliers in your para

3 dataset.

4 And I guess through exploratory

5 data analysis we maybe wouldn't rely totally

6 on a Spearman rank coefficient or the square

7 of that. We'd also look at the graphic. So

8 we'd look at both the visual inspection and

9 the statistical result.

10 But the use of Spearman rank is

11 pretty well established with environmental

12 data, and primarily because of its benefit for

13 being less sensitive to the outliers in your

14 data.

15 DR. FREY: Okay, thank you.

16 Yes?

17 DR. RABINOWITZ: If I could make a

18 comment on a comment?

19 DR. FREY: Absolutely.

20 DR. RABINOWITZ: Thank you. I very

21 much appreciated George Allen's comments about

22 trying to learn more about the residence time 

Page 135

1 of lead in soil. It's a challenging problem,

2 and of course there is this opportunity you

3 mentioned.

4 And I'd just like to comment and

5 suggest that there are other opportunities out

6 there. And for instance, we've closed any

7 number of smelters and we know when those

8 smelters were closed.

9 We know they're in different

10 climates, which may affect different soil

11 types, may affect residence time.

12 Indiana, for instance, in the '70s

13 and '80s there are any number of toxic waste

14 sites where they measured exact soil levels

15 and they know to within a foot where they took

16 that soil sample. In Indiana there are many

17 sites like that. Just to name one state.

18 There's also many in Utah, and you

19 could think of other states too, where people

20 have -- or the other side of Missouri.

21 Over in Joplin, what's left of it,

22 there used to be a large smelter. They knew

Page 136

1 exactly when it closed down. They knew

2 exactly how much soil was in it.

3 Already decades have passed since

4 those values were taken, so you have a chance

5 to see what may have happened in the meantime. 

6 So it's a good idea. Hope you have

7 better luck funding then I did.

8 DR. FREY: Yes, I think there's a -

9 -

10 DR. RABINOWITZ: Excuse me. If I

11 may add, there's also roads that have closed

12 too. Highways that have shut down abruptly. 

13 They know when it happened. Thank you.

14 DR. FREY: Yes, I think these are

15 good suggestions. The challenges that, if

16 these are really aimed at recommending future

17 studies then it doesn't quite help EPA in

18 revising the ISA.

19 But I think they are good things to

20 pass along to EPA, and I think as George

21 mentioned, you know, maybe it's useful for,

22 you know, the STAR grants program or ORD to

Page 137

1 keep these in mind.

2 DR. RABINOWITZ: Thank you.

3 DR. FREY: So yes, with I guess a

4 lot of the NAAQS reviews we tend to have kind

5 of a catch-all of things we'd like to

6 recommend to see done in the future, and this

7 certainly would be in that category.

8 Although I guess maybe part of what

9 you might be saying is that there's an

10 opportunity to mine some data, existing data,

11 to look at some of the issues that the ISA is

12 trying to address.

13 Or do you think that's such a

14 substantial effort that that's not something

15 that can be done by a second draft ISA?

16 DR. RABINOWITZ: No, it's just to

17 the future sometime. But I have other written

18 comments, which I'm sure you've all read all

19 of everybody's written comments.

20 That's why I mentioned this in the

21 meeting. It's more a question of resampling.

22 DR. FREY: Okay. Other panel
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1 member comments on Charge Question 3?

2 Well, then can I put George and

3 Rich on the spot to kind of synthesize what

4 you saw as maybe the top three to five points

5 that came out of panel member input?

6 MR. ALLEN: Thanks, Chris.

7 DR. FREY: You're welcome.

8 MR. ALLEN: The top three to five

9 off the top of my mind here. What pops out,

10 Phil's comments about dry deposition and that

11 you should have ultimate atmosphere at the

12 sinks. That's probably true for fine mode and

13 most likely not true for coarse mode. So

14 maybe there's a mode dependency upon, I'm sure

15 there's a mode dependency there.

16 Phil also noted issues with self

17 absorption with heavily loaded large particle

18 lead XRF analysis.

19 I don't know how much of the

20 network data, and there are several different

21 networks, how much of it is XRF and how much

22 of it is the various other back end analyses

Page 139

1 that would not have that issue. I don't have

2 a handle on that so I don't know how big a

3 problem it is.

4 (Off microphone discussion)

5 MR. ALLEN: Right, right. I mean

6 I think for the most part, the other non-XRF

7 techniques are probably pretty decent in

8 getting all the lead, whereas we know --

9 probably. Can I get a "probably" from you,

10 Phil?

11 Whereas, we know XRF, if it's

12 heavily loaded with big particles does have a

13 problem. And we don't know if it's been done,

14 corrections have been done properly. So

15 that's a big piece.

16 Let's see. Not to reiterate Rich's

17 comments or mine, because we know what they

18 are.

19 DR. FREY: Well, you've already

20 given two, so you only have --

21 MR. ALLEN: I have one more, okay.

22 Network, suitability of the network, Chris

Page 140

1 mentioned that. That's a good question. I

2 mean we're in a resource-constrained world. 

3 We do have more of a network now as

4 a result of the last NAAQS, maybe a better

5 network. It'll never be what we want or what

6 we need, so here we have the art of

7 compromise.

8 But, you know, we are, presently we

9 have a source-oriented network and then a

10 generic and core urban and a little bit of

11 rural, which is maybe all we can do and maybe

12 it's good enough.

13 We'd love to have more source14 oriented data. We're data starved for near

15 source data. But I don't, unfortunately, I

16 don't see those changing.

17 I guess that's my three. There's

18 a few others. Lead in rain, can I say that? 

19 Okay, thanks.

20 DR. FREY: Okay. Rich? Anything

21 else you saw as jumping out as a high level

22 point that we --

Page 141

1 MR. POIROT: I felt like we, again

2 the discrepancies in the recorded lead

3 measurements from the different size

4 distributions was just something we should

5 have to size.

6 And also sounds like something EPA

7 was already on the track to look at carefully. 

8 But to me that's quite important. You know,

9 and I think we just keep assuming that yes, we

10 ought to know how to measure lead.

11 But this has come up too many times

12 where, you know, and lead is sort of unique. 

13 In the sense of all the criteria pollutants

14 it's the one that becomes dependent on each

15 analytical laboratory in each of the different

16 states.

17 There are so many equivalent

18 methods that are out there that are

19 permissible. So I think it really, you know,

20 is something that we could emphasize a little

21 bit, but they're good.

22 Phil also had raised a point about
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1 Asian contributions, and I think I had noted

2 that in some of the written comments of

3 others.

4 It seems like something that's, a

5 closer look at it is quite doable from the

6 perspective of existing datasets. So maybe

7 that's something that could just be clarified. 

8 I don't know if it's a major point, but I

9 think it's quite doable.

10 DR. FREY: Okay.

11 MR. POIROT: Somebody like Phil can

12 do that.

13 DR. FREY: All right. Any last

14 thoughts on Charge Question 3 before we press

15 on? I think we've covered the terrain there

16 for the moment.

17 So we're still ahead of lunch. I

18 think we ought to press on with our next

19 charge question, which is 4a, and see where we

20 are at noon, whether we want to finish up that

21 discussion or just break at noon for lunch.

22 So we'll see how the discussion

Page 143

1 goes on, at least on 4a. And for that charge

2 question the lead discussant is Dr. von

3 Lindern, and then the other discussants are

4 Drs. Goodrum and Hopke.

5 So Dr. von Lindern, the floor is

6 yours.

7 DR. von LINDERN: Well, I'm over

8 here struggling with whether to make this

9 short or long. Lunch has something to do with

10 that.

11 DR. FREY: Yes, how popular do you

12 want to be?

13 DR. von LINDERN: Most of my

14 concerns seem to be rendered irrelevant by the

15 process eliminating those things that I'm

16 concerned about here for consideration.

17 So if I stick to the charge

18 question and just answer that it'll be short. 

19 If I get to put my complaints out it will be

20 longer.

21 So I think Chapter 4 itself was

22 pretty well put together. I think it answers

Page 144

1 the questions adequately. I'll just briefly

2 go through that.

3 There is an early discussion in

4 that chapter about the effects of the phase

5 down from, in air lead levels. I think that's

6 good, but I see this entire document

7 attributes most of the success in reducing air

8 lead levels to the phase down.

9 There were, in fact, much larger,

10 and reductions in the magnitude of exposures

11 around the stationary sources in the country

12 and much greater drops in blood leads amongst

13 the population surrounding those stationary

14 sources. That seems to have been forgotten,

15 and it would be good to remind ourselves of

16 that.

17 There is a discussion of indoor and

18 outdoor exposures in there. Every time we

19 have one of these meetings somebody says

20 outdoor's greater, and then the next meeting

21 somebody says indoor's greater, and it's gone

22 on that way for years.

Page 145

1 It seems that those are site

2 specific conditions and it could be either way

3 and maybe we should just acknowledge that.

4 And then the remainder of this

5 section goes through other media. I think

6 part of what's missing there is, and we've

7 heard it a number of times here, only looking

8 at new information.

9 A little summary at the beginning

10 about how much media concentrations have

11 changed over the years would be helpful I

12 think.

13 We have seen large reductions in

14 these other media concentrations throughout

15 the country, and it would be good to give that

16 the same amount of attention that we give to

17 air.

18 And then moving on to the portion

19 about pathways and does the ISA adequately

20 describe the balance of air related and non21 air related pathways.

22 There are many pathway specific
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1 exposures to children and to adults that vary

2 considerably due to a lot of other factors,

3 lifestyle, behavioral, cultural factors. And

4 in different situations, one pathway or

5 another can be dominate.

6 And I think as we're moving into

7 other populations rather than these North

8 American and European studies that all of this

9 is based on, we're finding that other pathways

10 are more important and that there are a number

11 of ways in which the intake and uptake can

12 vary significantly.

13 And maybe we're becoming too myopic

14 about the populations that all of this history

15 has been based on and maybe should discuss a

16 little bit more how these various pathways

17 influence intake and uptake and the other

18 socioeconomic, ethnic and behavioral factors

19 that can influence that. I don't know that

20 there's good treatment of that there.

21 And I think this might be

22 particularly important when we begin to

Page 147

1 consider some of the susceptible populations

2 later on, particularly immigrant populations

3 that are bringing some other habits and

4 behaviors with them that could be important in

5 that factor.

6 Those are my main comments with

7 respect to the question. Now if I can

8 complain, which requires me going back to

9 Section 3. If we are, and maybe I'm just dead

10 wrong on this, I don't understand.

11 But if this is the information that

12 is going to be used to provide the basic data

13 for an exposure assessment to go into the

14 policy document that's going to end up with

15 the administrator, it is woefully inadequate.

16 If there are other opportunities to

17 bring other data and information into this

18 process later on maybe it's going to work. 

19 And that's where my primary confusion is.

20 There is in Chapter 3, absolutely

21 no information whatsoever about the role of

22 lead in U.S. commerce, the production of lead

Page 148

1 in the United States, the uses of lead in the

2 United States, the distribution of that lead,

3 where's it being disposed, where it's ending

4 up. Is it being shipped overseas? None of

5 that is in here.

6 Is that going to be developed

7 somewhere else or is it going to be ignored in

8 the policy determinations? That's a big

9 question for me.

10 Next, with regard to the ambient

11 data, we've just had a discussion about, this

12 document has done a good job of summarizing

13 the ambient data that's out there.

14 But nobody points out that that

15 ambient data is woefully inadequate in telling

16 us whether we're in compliance with the NAAQS

17 in the country, where the exposures are at,

18 what the concentrations are around key

19 populations.

20 It seems as if we don't know that. 

21 Is that something that's going to be developed

22 later or are we saying now that we don't know?

Page 149

1 In the last document, this is

2 another consideration of the only looking at

3 new data. In the last round we concluded that

4 there wasn't sufficient data out there to

5 evaluate this question, and it was a big

6 inadequacy in the document.

7 And it seems that the obligation

8 was on the agency to develop that information

9 in the last three to four years. That seems

10 to have not been done.

11 And we're going to come to the

12 conclusion that there isn't sufficient data to

13 conduct an adequate risk assessment, so we're

14 going to go back to doing pilot modeling.

15 I don't think that message was

16 delivered here at all that we don't have a

17 good handle on the ambient concentrations out

18 there.

19 We don't have a good monitoring

20 system for it yet, but is this process just

21 going to conclude that then we don't need to

22 look at it, we can stick with the same
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1 information?

2 That's difficult for me to

3 understand, how the agency is dealing with

4 that. And that should be pretty close to 12,

5 so I'll cut off there.

6 DR. FREY: Okay. Actually we're

7 still ahead of 12. It's about 10 of.

8 Well, thank you for the comments. 

9 So I think some of what you said actually

10 touched on Chapter 3 and may be something that

11 George and Rich may want to consider in

12 developing the summary.

13 And Phil, yes, do you want to

14 comment?

15 DR. HOPKE: Yes, I mean I think you

16 have to understand how criteria pollutants are

17 regulated. The key is that these are from a

18 variety of sources giving rise to general

19 exposures.

20 The specificity of where lead comes

21 from and how it's used really comes into play

22 when people start to develop state

Page 151

1 implementation plans. And so it's not clear

2 that we should be getting into that level of

3 detail in the Integrated Science Assessment.

4 Now again, what Chapter 3 tries to

5 do is portray a picture of the concentrations,

6 and then Chapter 4 should explain how it moves

7 those concentrations to estimate the basis for

8 moving those to exposures, whereas, the

9 exposures themselves would be then calculated

10 in the exposure and risk assessment later.

11 So we have to be careful as to just

12 what parts of the process each of these things

13 is trying to achieve.

14 DR. FREY: Okay. Well, let's

15 continue then on Charge Question 4a with Dr.

16 Goodrum.

17 DR. GOODRUM: I'm going to try to

18 keep my comments short as well. I focused

19 more on 4c, which is a subset of 4. So

20 specifically to the questions in the charge,

21 the organization and the content I thought was

22 logical.

Page 152

1 The amount of information that was

2 spent on revisiting exposure in biokinetics

3 and the empirical information that allows us

4 to relate biomarkers to estimates of exposure

5 I thought were appropriate and matched the

6 charge in terms of trying to introduce the new

7 literature and information that was available.

8 I do think I'd like to echo what

9 Ian said in terms of helping the reader out

10 with some short synopsis of what's known to

11 date on changes over time in certain exposure

12 media.

13 And just one example would be

14 looking at the background documents in support

15 of IEUBK for dietary exposure and just tracing

16 over time FDA's data and estimates of average

17 daily intake through the diet pathway.

18 That's pretty well established and

19 well vetted analysis and could be captured in

20 a succinct way. And along those lines, I

21 think there's an opportunity maybe in this

22 chapter, to start to guide the reader a little

Page 153

1 bit more.

2 Because we're moving from exposure

3 into more of the modeling and the use of

4 empirical data, is to try to frame the

5 discussion in terms of what empirical

6 information is there to inform estimates of

7 background, so for populations that are not

8 near a smelter or near some active source.

9 But we're talking about background

10 levels. The types of discussions that would

11 accompany evaluations of the NHANES blood lead

12 data, for example.

13 The structured mechanistic models

14 provide one point of view on the relative

15 contribution of air to both the outdoor and

16 indoor reservoirs and just through direct

17 inhalation.

18 I think it would be interesting to

19 start to set the stage for, you know, if we're

20 going to use those models.

21 And on the one hand, to help inform

22 the risk assessment down the road and the
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1 policy, how do those assumptions that are

2 built into that model now line up with the

3 data that we have from the multivariate

4 analyses where we've tried to tease apart the

5 relative contribution of air to some of the

6 other pathways?

7 So we have an opportunity here to

8 maybe revisit a verification of the

9 contribution of air.

10 I've used the IEUBK model quite a

11 bit, but more for Superfund site assessments

12 where air is not the driver, and here we have

13 the opposite focus where we're trying to

14 understand to what extent air is the driver.

15 And so I think it behooves us to

16 revisit this question of air contributions to

17 soil and dust and connecting empirical data

18 with the modeling assumptions.

19 DR. FREY: Okay, thank you.

20 Let's see, Phil?

21 DR. HOPKE: Yes, I thought this

22 chapter was in reasonably good, part of it I

Page 155

1 could follow which was 4-1, which is what I

2 was asked to do. However, there's no

3 discussion of exposure models.

4 And EPA has put considerable effort

5 into coming up with TRIM, which I was under

6 the impression was now available.

7 And, you know, so the question is,

8 how do you put these pieces together? And it

9 seems like the science of the exposure

10 modeling should be included in here because

11 there's got to be some way to put those pieces

12 together when you move on from here to the

13 exposure and health risk assessment.

14 Lead is different than most of the

15 other criteria pollutants because we are

16 worried about multiple pathways.

17 And therefore, how you, what the

18 state of the science on modeling those various

19 pathways as well as elucidating what those

20 pathways are, are both important to providing

21 the basis for the next step forward.

22 And I didn't see any of that in

Page 156

1 here. I mean I assume that there's going to

2 be some sort of exposure modeling, multi3 pathway exposure modeling.

4 It's certainly going to be needed

5 in the next step, and the basis for that

6 should be here in the ISA.

7 The other major thing that I saw

8 missing was that, you know, obviously several

9 years ago we had the major episode of the

10 Chinese lead-painted toys and that was not

11 included in Table 4-6.

12 And given that this led to

13 substantial action by other regulatory

14 agencies in the United States, you know, it

15 doesn't have anything bearing on the air

16 quality standard, but in terms of you've got

17 other sources of lead mentioned in here,

18 that's certainly an incident of sufficient

19 magnitude that it warrants incorporation into

20 Table 4-6.

21 DR. FREY: Okay. Other comments on

22 specifically Charge Question 4a?

Page 157

1 Yes, Dr. Kosnett?

2 DR. KOSNETT: Well, I'm inclined to

3 look now and see whether my comments were just

4 specifically to 4a. Actually more on 4b. So

5 I spoke too soon.

6 DR. FREY: Okay. All right, other

7 comments on 4a?

8 Okay, Dr. von Lindern, would you

9 want to take a stab at maybe what are the top

10 two or three main points that come out of

11 this?

12 DR. von LINDERN: Maybe you don't

13 want me, right? I would like to ask EPA a

14 question first to help me --

15 DR. FREY: Okay. Sure, that's

16 fine.

17 DR. von LINDERN: -- in that

18 regard. I don't see in Sections 3 and 4, a

19 conclusionary nature like there was in the

20 health chapters with regard to causality.

21 And if I were drawing a conclusion

22 with regard to Chapter 3 and 4 in terms of, is
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1 there an adequate database presented in this

2 document to support exposure analysis, I would

3 have to say no.

4 But is that important to this

5 document? And it harkens back to another

6 thing that happened in the last review that's

7 not happened here, is the professional trade

8 literature available to help develop that

9 exposure information?

10 Because that's where it's at. It's

11 not in these peer reviewed journals. And if

12 the agency is going to do a credible job at

13 some time, they're going to have to access

14 that data. Does that happen later in this

15 process or are we going to live with what's

16 there now?

17 DR. FREY: Well, if you're asking

18 me, I don't know all the answers to that. But

19 I guess one distinction that tomorrow we will

20 review the scope and methods plan for the risk

21 and exposure assessment.

22 And I think the question about

Page 159

1 trade literature as it pertains to the REA

2 would be something we could talk about

3 tomorrow.

4 But I guess the trade literature as

5 it pertains to the ISA is something we could

6 certainly ask the folks here at the front of

7 the room about today.

8 And I don't know if, John, maybe

9 you want to comment on that?

10 DR. von LINDERN: It's not trade,

11 it's trade but it's EPA's files. They can

12 look in their own files and they can find this

13 information. Will they do that?

14 DR. FREY: You're saying literature

15 that's not, it's not peer reviewed journal

16 papers. It's things other than that.

17 DR. VANDENBERG: Yes, that's an

18 important clarification, what you meant by

19 trade literature versus what information's

20 available to the agency, we do consider that.

21 So maybe you can clarify what you

22 meant. Maybe you just did. Is that what you

Page 160

1 meant, is what EPA has in terms of the

2 monitoring data, the data that's available to

3 us through either EPA's files or NHANES or

4 other collaborations? Is that what you're

5 referring to?

6 DR. von LINDERN: And in the other

7 programs in EPA. There's lots of exposure

8 information, that hundreds of sites in this

9 country that can inform this document with

10 regard to exposures out there, but it's not

11 included at this point.

12 This is where I'm confused. If

13 this is really a literature review of the peer

14 reviewed literature, then I think it should

15 conclude that in the peer reviewed literature

16 there's not sufficient exposure information to

17 go forward.

18 But there is sufficient exposure

19 information somewhere else. Is the agency

20 going to access that later?

21 DR. VANDENBERG: I'd like to say I

22 have the answer to that because we do focus on

Page 161

1 the peer reviewed literature, and then data

2 that's available to EPA such as through the

3 Ambient Air Quality Monitoring System that's

4 used that's reflected here in the data that

5 you were saying earlier.

6 But in terms of the data that might

7 be available to our other program offices, we

8 may or may not be bringing that in in the

9 manner that you're referring to here.

10 And so I think that may be a

11 comment we certainly would welcome, but I

12 don't have a particular good answer for you

13 right now, I'm afraid.

14 I'll look to my colleagues here. 

15 I don't know, Mary, if you have any comment

16 about that?

17 (Off microphone discussion)

18 DR. VANDENBERG: Yes, are you

19 talking about the Superfund sites? As an

20 example of that.

21 DR. von LINDERN: Yes.

22 DR. VANDENBERG: Yes, we can look
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1 into it.

2 DR. von LINDERN: So now I'll try

3 and answer your question.

4 DR. FREY: I'm sorry?

5 DR. von LINDERN: I'll try and say

6 what the concern --

7 DR. FREY: Okay.

8 DR. von LINDERN: Actually, no

9 particular order, but maybe some additional

10 discussion about modeling because, and the

11 science of modeling.

12 I think some additional discussion

13 of the significance of different exposure

14 parameters with regard to the peculiarities of

15 different subpopulations that we're likely to

16 see, more history about the media

17 concentrations.

18 Well, and then my pet peeve. It

19 wasn't all gas. There were a lot of smelters

20 that were closed too. So that should be

21 included in the discussion of lowered

22 exposures over the years.

Page 163

1 I would like to suggest that there

2 be more conclusions drawn in Chapters 3 and 4,

3 more similar to the health sections, and those

4 conclusions drawn with regard to the adequacy

5 of the databases as they're presented to

6 support further analyses.

7 And particularly those databases

8 that really it's the responsibility of EPA to

9 collect and develop those. But I'll take

10 advice from my fellow members on whether we

11 should put that sort of thing in the

12 recommendation or not.

13 DR. FREY: Yes, I think as I

14 mentioned, you know, I think almost every

15 panel gets into a territory that has to do

16 with recommending what EPA should do to get

17 more or better data.

18 And that's sort of a different

19 flavor of recommendation than commenting on

20 the ISA and how, you know, how should EPA

21 revise for the second draft ISA.

22 So I think we can certainly compile

Page 164

1 some of those thoughts and think of a way that

2 we might pass that along to EPA, but it's sort

3 of a different kind of an animal in that

4 regard.

5 Phil?

6 DR. HOPKE: Again, once upon a time

7 us old-timers remember we used to come up with

8 research needs assessments after each round.

9 But those disappeared because they always

10 turned into massive laundry lists instead of

11 targeted priorities.

12 DR. FREY: Yes, and I think we did

13 something like that with PM in the recent

14 review, and so I don't think it's totally gone

15 away.

16 DR. VU: Last year at one of the

17 meeting with CASAC, I forgot which panel it

18 was. I think it was ozone. No, it wasn't

19 ozone, it was PM I think, or the year before.

20 But we did discuss with, I did have

21 a discussion with ORD about doing some kind of

22 a meeting with CASAC to look at the specific

Page 165

1 research needs for the air pollution NAAQS

2 program.

3 So I'll continue to talk with them

4 about it, but I know these are some of the

5 urging needs that from CASAC's trying to help

6 the agency prioritize some of the key data

7 gaps, that you all would like to see.

8 So I will keep you informed where

9 that is, okay. I know Dan is busy so we'll

10 see where we are.

11 DR. von LINDERN: Can I make one

12 clarification?

13 DR. FREY: Sure, go ahead.

14 DR. von LINDERN: Although I'm all

15 for lead research, I'm not advocating

16 additional lead research.

17 I'm trying to point out that this

18 information that is necessary to move forward

19 has traditionally been collected by EPA as

20 part of their statutory responsibilities. 

21 That has not happened in the last few years. 

22 And as a result, that database is
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1 not available. Not because the research

2 hasn't been done and isn't in the peer

3 reviewed literature. It's because the

4 monitoring has not been done.

5 And that isn't research monitoring,

6 that is monitoring to help characterize the

7 extent of exposure in the United States. That

8 doesn't seem to be there.

9 Perhaps it's available in some of

10 the other venues in EPA. I don't know whether

11 this group is attempting to look for that. 

12 That's the question.

13 DR. FREY: Okay. All right, just

14 mindful of the time and lunch. So any last

15 thoughts on 4a before we break for lunch?

16 Okay, so I think we'll go ahead and

17 take a, I think we were scheduled for a one18 hour lunch. So we'll go ahead and do one hour

19 for lunch. Let's just say that we'll

20 reconvene at 1:15, and enjoy your lunch.

21 (Whereupon, the foregoing matter

22 went off the record at 12:10 p.m.

Page 167

1 and resumed at 1:15 p.m.)

2 DR. FREY: Our next agenda item is

3 to discuss Charge Question 4b. 4b is on the

4 topic of biological markers.

5 And I think we'll go ahead and do

6 Charge Question 4b, and then we might come

7 back for a few minutes to -- EPA has some

8 clarifications they want to provide on the

9 process.

10 But we'll do that I guess after 4b,

11 would that be okay? Or are you ready now?

12 DR. VANDENBERG: We can do it any

13 time I think.

14 DR. FREY: Okay. Well, if you're

15 ready now then maybe this is a good time.

16 So yes, we thought we would take a

17 minute and just offer some clarifications

18 since some of the questions, or comments we've

19 been hearing kind of touch on the interface

20 between the Integrated Science Assessment and

21 the risk and exposure assessment.

22 And EPA can help clarify some of

Page 168

1 those distinctions and some of the other

2 issues that have come up.

3 So, John?

4 DR. VANDENBERG: Thank you, Dr.

5 Frey. Just again for clarification. I'm

6 joined here by Dierdre Murphy, who's with the

7 Office of Air Quality Planning and Standards. 

8 And Dierdre will be one of the

9 point persons tomorrow when we're talking

10 about the risk and exposure assessment, but

11 OAQPS also deals with the policy assessment.

12 And again the research and

13 development wing of EPA tends to support the

14 discussion and the consideration of science as

15 we go into those next stages in that overall

16 flow chart that I was talking about.

17 But I thought it would be helpful

18 to just sort of step back and talk about the

19 different pieces of all of the assessment

20 activities that are going on to support the

21 decision making.

22 And then also speak as Dr. Hopke

Page 169

1 did, that some considerations come in quite a

2 bit later in terms of state implementation

3 planning where things like economic impacts

4 are considered.

5 That's not considered in the

6 standard setting process, but it is considered

7 when it comes to the states developing plans

8 to meet the standard. And that's where

9 economic impacts would play a role.

10 And issues like how is lead used in

11 commerce or how is it, you know, influencing

12 other things, that's a separate step from the

13 process that we're involved with right now.

14 So just to sort of set the stage

15 is, a few years ago when we were struggling

16 with a lot of the Air Quality Criteria

17 documents, one of the struggles we had was the

18 scope of them became ever larger.

19 And so there was a sense of almost

20 crisis in the program is that we needed to

21 really recognize that the purpose of the

22 Integrated Science Assessment is to support
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1 the standard setting process.

2 In addition, it directly supports

3 the risk and exposures assessment work and

4 ultimately the policy assessment that the Air

5 office is charged with developing.

6 So if you think about these pieces,

7 one of the things that we're trying to do is

8 to focus on the information that is most

9 informative, most policy relevant to the

10 standard setting process.

11 And through that process of

12 interactions with different CASAC committees,

13 we've kind of developed this existing document

14 that you have now.

15 And as I mentioned in my opening

16 comments, we're continuing to improve the

17 document to try to add more analysis, more

18 interpretation, more focus.

19 More user friendly in some ways by

20 adding figures and tables and information that

21 helps the audience, and of course there's a

22 lot of audiences here to understand the nature

Page 171

1 of information and how ultimately that helps

2 the administrator in setting the standards.

3 So when you consider that, one of

4 the things that we have focused on is the

5 information that is most relevant to the

6 standard setting itself.

7 And some of the questions that were

8 being discussed a little bit before the break

9 related to datasets that might be viewed as

10 somewhat outside of that. And one of the

11 things we're struggling with, and it would be

12 useful to get the comments from CASAC members,

13 is how that information might help inform

14 either the interpretation of the science or

15 its application perhaps subsequently in the

16 risk and exposure assessment and policy

17 assessment.

18 So we're trying to sort of process

19 some of that earlier discussion to make sure

20 that we understand the points being made.

21 And with that I'm going to ask

22 Dierdre if she wanted to add anything to it as

Page 172

1 well, because part of it is the information

2 that we tend to present in the ISAs is the

3 empirical data. It's a lot of information on

4 the data that's available.

5 And in terms of projections, in

6 terms of modeling, in terms of looking at

7 different policy options, that's where the Air

8 office comes in.

9 So would you like to add anything

10 to that?

11 DR. MURPHY: Yes, I'll just add,

12 because I was reflecting on that conversation

13 over lunch as well. And I think another piece

14 to clarify is something that was talked about

15 earlier.

16 That the mode of the ISA is sort of

17 an update mode. And that to the extent it

18 does not pull in previously assessed and

19 considered information, that information is

20 still available to the agency for our use.

21 And so as John alluded to we have

22 some downstream documents from the ISA. We

Page 173

1 consider whether or not we're going to do a

2 new risk and exposure assessment.

3 And that's a topic of conversation

4 tomorrow where we have an REA planning

5 document which was intended to evaluate, what

6 is the newly available information and does

7 that lead us to conclude that an updated risk

8 assessment is warranted?

9 We did a complex one in the last

10 review. The results of that analysis are

11 still available to us to consider in this

12 review as is all of the information that was

13 assessed in previous CDs, the Criteria

14 Documents, in addition to what's assessed with

15 this criteria document.

16 And when we come to the next

17 document, which is the policy assessment

18 document, that's where it all comes together. 

19 Because we, you know, OAQPS then say okay,

20 there are a couple of key questions for us.

21 Does the newly available evidence

22 call into question the adequacy of the current
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1 standards? That's kind of an overarching

2 question for us. And so, you know, we look

3 at, okay, what's new and how does that fit

4 into what we knew before?

5 Does it cause us to change our

6 conclusions about things which are important

7 with the regard to the protectiveness and the

8 adequacy of the current standards?

9 And so I think just keeping in mind

10 that although the ISA strives to be

11 streamlined, we in EPA still reach back for

12 all the pieces of information that support

13 that from previous reviews. And we'll pull

14 that out as appropriate in the policy

15 assessment.

16 The other piece of information that

17 I think was touched on was different types of

18 data sets and whether or not they would be

19 appropriate to be talked about in the ISA or

20 in other documents.

21 And to the extent they are data

22 sets and can be mined for relationships and

Page 175

1 things like that, they can be touched on in

2 any of these documents.

3 In terms of one example of a

4 relationship I recall being essential in the

5 assessment that we did in the last go around,

6 the exposure risk assessment is we had some

7 Housing and Urban Development databases on

8 dust lead and housing age in different cities.

9 And we used that to help us

10 understand background concentrations of dust

11 lead to feed some modeling we did to project

12 changes in air lead, changes in dust lead that

13 were important to exposure modeling.

14 So we did draw on existing data

15 sets that either were published in agency

16 reports, either our agency or other agencies. 

17 We worked with some Superfund data near the

18 primary smelter site that we had, because that

19 helped us work on relationships between dust

20 lead and air lead.

21 So there are different places where

22 those types of data can be used throughout the

Page 176

1 review process.

2 DR. VANDENBERG: So the point is,

3 I guess we wanted to just give an opportunity

4 for any other questions or discussions to us

5 in terms of how this process, where we are in

6 the process.

7 And again it's a multi-year, multi8 step process. And try to put sort of an

9 understanding around this document that you're

10 commenting on today and the document being

11 reviewed tomorrow.

12 And then again you all are going to

13 be with us for years, so I want to make sure

14 we're all on the same page, okay?

15 DR. FREY: Okay, any questions by

16 members of the panel? EPA? Everything's

17 clear.

18 DR. VANDENBERG: Good. Well, thank

19 you for the opportunity to clarify.

20 DR. FREY: Okay, sure. Well, thank

21 you for the clarification. Okay, well, with

22 that let's pick up where we left off, which is

Page 177

1 to start on Charge Question 4b on biological

2 markers.

3 And our discussants are Drs.

4 Pounds, Hays and Korrick. And Dr. Pounds, the

5 floor is yours.

6 DR. POUNDS: Thank you. So I

7 talked briefly with my codiscussants at lunch,

8 Susan Korrick and Sean Hays, and I regret to

9 inform you that you'll probably not be

10 entertained by bloody intellectual combat

11 complete with prisoners and body counts,

12 although it's always dangerous to

13 underestimate the provocative abilities of Ian

14 or the two Michaels.

15 It seems that most of our comments

16 are related to the charge of identification of

17 topics that require additional or clarifying

18 discussions, and of which collectively we have

19 five or six.

20 I think they often come under the

21 context of putting the new data in context, as

22 has been discussed with the previous chapters.
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1 The perspective, for example,

2 clarification, Section 4.2.1, which is on

3 absorption, defines the terms absorption,

4 bioavailability and bioaccessibility.

5 And it gives the definitions of

6 absorption and bioavailability that do not

7 make these terms very distinct. And I think

8 just, you know, invokes some confusion later

9 in the chapter.

10 The chapter defines absorption as

11 referring to the fraction of lead absorbed

12 from the respiratory or gastrointestinal

13 tract, while bioavailability refers to the

14 amount of lead ingested or inhaled that enters

15 systemic circulation.

16 So it's not clear whether it's the

17 units, fraction versus amount, or whether it's

18 absorbed in systemic circulation or not that

19 distinguishes these two terms.

20 The ambiguity is furthered by the

21 apparent interchangeable use of these two

22 terms in different parts of the chapter. And

Page 179

1 I suspect that most of the inconsistent use

2 results from carryover from the authors' usage

3 in the original paper.

4 So I'd suggest that these

5 definitions be revisited and that the entire

6 ISA document be reviewed to ensure the

7 consistent use of the clarified definitions

8 across the document.

9 In a similar vein, Section 4.3 and

10 elsewhere, defines the definition and

11 application and limits of biomarkers. This

12 section really should be expanded and carried

13 into, you know, 4.7.3.

14 That is to say that the section

15 would be well served by defining the

16 distinction between validation and application

17 of biomarkers for exposure, body burden, dose

18 and risk, which are kind of the general

19 categories of biomarkers.

20 It's clear from the text that the

21 ISA recognizes that lead biomarkers are not

22 equally valid when applied to different

Page 180

1 exposure scenarios, and have actually done a

2 very nice job of illustrating that.

3 But it's easy for all of us to use

4 and interpret biomarkers in a facile manner

5 without really communicating the biomarker for

6 what, and the limitations of the biomarker for

7 that particular purpose.

8 This chapter contains cogent, but

9 really scattered throughout it, discussion

10 related to this issue.

11 And because blood lead and bone

12 lead are used for risk assessment and risk

13 management, I suggest that it's important to

14 bring this discussion up to the front of the

15 Section 4 and include it in the summary, as

16 well as to review the remaining parts of the

17 ISA to ensure consistent use of these terms.

18 I have a couple other additions,

19 but I, make sure that other people have a

20 chance to -- Susan?

21 (Off microphone discussion)

22 DR. POUNDS: Do you want to talk

Page 181

1 about the uncertainties of the bone lead

2 measurement?

3 DR. FREY: Well, you're welcome to

4 go next if you're ready to go.

5 DR. KORRICK: Were you done? Is

6 that --

7 DR. POUNDS: I've got a couple

8 more, but I'll pass, unless we've got time.

9 DR. KORRICK: Oh, okay. So yes, so

10 I actually, I apologize, Joel. I did have a

11 few things when I went back and looked at my

12 notes that were perhaps a little more

13 controversial.

14 And I think my, I focused my review

15 on Section 4.3 where I think that the section

16 does reflect current knowledge, and that the

17 focus is appropriate in terms of blood and

18 bone lead.

19 But I think I had one question

20 which perhaps the EPA or others could help me

21 understand, which is that it seemed as if this

22 section relied pretty heavily on the ICRP lead
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1 kinetics, biokinetics model to demonstrate

2 relationships among different biomarkers.

3 And I suppose, I'm not a modeler,

4 so I suppose it's useful for demonstrating

5 some theoretical relationships. But I found

6 it a little difficult to understand the

7 context in which those models are relevant to

8 interpretation of the health effects

9 literature.

10 For example, there's a model in

11 there that suggests that with a short term

12 lead exposure, blood lead returns to baseline

13 levels even though body burdens go up, which

14 probably is not what you would necessarily see

15 in the epidemiologic literature.

16 And there are other parts of the

17 report that talk about the challenge of

18 looking at blood leads in older adults, which

19 likely reflect a combination of recent

20 exposures as well as long term body burdens.

21 And that's not really reflective in

22 some of these models. And I have a hard time

Page 183

1 understanding how these models help inform

2 interpretation of the relationship of these

3 biomarkers to health outcomes in the real

4 world.

5 And I wondered why there wasn't

6 more in this section that looked at available

7 data demonstrating relationships among

8 biomarkers in a biologically relevant context.

9 In other words, in an epi context

10 or in human populations as opposed to in the

11 modeling.

12 So I may be missing something, but

13 I found it hard to see the role of these

14 descriptors and wondered why other kinds of

15 descriptions were seemingly lacking in the

16 section.

17 So I don't know if that's something

18 that you all want to address, or am I, I'm

19 probably not understanding the basic issue.

20 DR. POUNDS: Susan, what model

21 specifically --

22 DR. KORRICK: Well, it's the ICRP,

Page 184

1 the International Commission on Radiological

2 Protection. A lot of the information in

3 Section 4.3 related to relationships among

4 biomarkers is based on this theoretical model

5 as opposed to based on empirically observed

6 data. And I have a little problem with that.

7 DR. VANDENBERG: Would you like to

8 -- yes.

9 DR. FREY: Yes, if you have some

10 clarification that would help.

11 DR. STANEK: Well, a couple of

12 comments I guess. So we attempted in the

13 kinetic section to present empirical data, and

14 then in Section, I think was it 4.3?

15 DR. KORRICK: Yes, it's 4.3.

16 DR. STANEK: Yes, we went into the

17 more modeling. So we tried to present both

18 the data that we had available on kinetics in

19 the chapter as well as using the models just

20 to present the data both ways, because there

21 are some areas where we don't have data,

22 empirical data, and so we relied on the models

Page 185

1 more.

2 Just more to look at the

3 relationships between how lead moves

4 throughout the body as opposed to linking it

5 specifically to health effects.

6 DR. KORRICK: But I guess where the

7 models seemed to predict things that aren't

8 confirmed in the empirical observational data,

9 would it possible to have some acknowledgment

10 of that in this section?

11 You know, I think, again I admit

12 I'm not a modeler, but I think there are

13 limitations to these models probably in terms

14 of assumptions.

15 And the empirical data that are

16 available suggests to me that some of these

17 models are not necessarily applicable to a lot

18 of real work. So some sort of acknowledgment

19 of that.

20 Maybe that's in there, but I felt

21 like I didn't get a sense that the limitations

22 and roles of these models was very well
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1 delineated.

2 DR. STANEK: We tried to outline

3 that at the beginning of that section, but

4 maybe we didn't do a very good job. So if you

5 can provide us specific examples where these

6 models are not doing a good job.

7 DR. KORRICK: But even Figure 4.10,

8 the upper panel sort of implies that, you

9 know, you get a lead exposure and then your

10 blood leads normalize back to where you

11 started. This is on Page 449.

12 And in adults that's probably, I

13 mean it's probably not how it works based on

14 real-world observational data.

15 DR. HAYS: Do you know of real16 world observational data that shows that?

17 DR. KORRICK: That shows that? 

18 Well, I mean I think it --

19 DR. HAYS: That shows the opposite

20 of this?

21 DR. KORRICK: Not the opposite, but

22 in general if you get an exposure over a fivePage 187

1 year period, depending on the nature of the

2 exposure, your blood lead may, especially in

3 an adult, your blood lead may be higher at the

4 end of the period.

5 It will necessarily, because you're

6 going to, there's going to be some equilibrium

7 between blood and bone compartments which will

8 reflect the increase in body burden that's

9 been accrued over that intervening time. And

10 this model suggests that that doesn't go on.

11 I mean I think the reason I'm

12 pointing that out as an example is elsewhere

13 in this document there's a lot of discussion

14 about the difficulty of interpreting blood

15 leads in adults because they reflect body

16 burdens and bone stores.

17 And if we're going to, and I think

18 that's a reasonable issue. And if that's an

19 important issue in understanding the health

20 effects studies in adults, then to have a

21 model in the document that sort of implies

22 that's not what happens seems a little

Page 188

1 contradictory.

2 And for purposes of internal

3 consistency, I think it's important to make

4 sure that the ways in which we're thinking

5 about these biomarkers, whether it's through

6 modeling or empiric evidence, are consistent

7 so that there's a body of sort of paradigms

8 for thinking about exposure and interpreting

9 exposure measures in the health literature.

10 I don't know if that makes sense.

11 DR. POUNDS: I think in these

12 figures as was well with some of the others,

13 when there's a change, in this case, the blood

14 that's -- I'm sorry, the leads that's input to

15 the model drops to zero. All right.

16 That what that means is the

17 epidemiologists don't do that kind of

18 experiment.

19 DR. KORRICK: So it's not real. I

20 mean it's not how people really expose.

21 DR. POUNDS: It's trying to show

22 the relationships. It's not trying to, in

Page 189

1 this particular instance I think, it's not

2 trying to model real-life scenarios.

3 DR. KORRICK: So how does this then

4 help us with the task of the ISA? Maybe

5 that's too broad a question, but I just kind

6 of lost track of where this actually fits into 

7 figuring out how to understand.

8 DR. FREY: Let me see if I can

9 maybe summarize or focus a little bit. It

10 seems like the, if I understand the comment

11 you have, it seems to be in part what I'm

12 hearing is a preference for using empirical

13 data where it's available.

14 And then if there's some reason why

15 EPA felt the model was a more valuable way of

16 generating insight on the one hand, to make

17 more clear why that was better than using

18 empirical data, or maybe there wasn't

19 empirical data.

20 But then I think a related issue

21 is, how valid is the model? How's it been

22 evaluated or validated for these applications? 
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1 And then a third thing I think I heard was,

2 the case studies being used with the models

3 may or may not represent perhaps a realistic

4 scenario.

5 But maybe that's intentional

6 because they're trying to tease out a specific

7 kind of interaction, and maybe that's not

8 clear. So are those kind of --

9 DR. KORRICK: Yes, you said it much

10 better than I did.

11 DR. FREY: Okay.

12 DR. KORRICK: Thank you.

13 DR. FREY: So I think, and that's

14 probably just feedback for EPA that they could

15 either clarify it and, you know, address those

16 kind of, those three points.

17 DR. KORRICK: I mean I think these

18 are important issues because they're really

19 important to how we interpret the epidemiology

20 in ways that allow us to understand exposure

21 risks. So I think it's not a minor issue.

22 I think the other, I had mostly

Page 191

1 more minor comments. I think that in the

2 Section 4.3 there's some reference to the

3 previous Air Quality Criteria document showing

4 information about measurement error in bone

5 lead.

6 And I think it would be helpful to

7 at least repeat some summary data related to

8 that, since bone lead is definitely measured

9 with a fair amount of error depending on the

10 nature of the population being assessed.

11 And I think that becomes an

12 important consideration when interpreting the

13 health effects literature. And I think the

14 other, these are again more minor comments.

15 There was a discussion about

16 challenges in bone lead measurements because

17 they're normalized to bone mineral content,

18 and that adds a source of error.

19 I think that the physicists that

20 I've talked to about this would say it doesn't

21 add error so much as it, in the context of low

22 bone mineral content, it increases measurement

Page 192

1 uncertainty because you're just basically

2 generating less data to estimate exposure.

3 So I think that's a slightly

4 different take on it, and I think it is

5 important to acknowledge as part of the sort

6 of QA/QC parameters around some of these

7 different biomarkers that for bone lead in

8 particular, variations in bone status can

9 impact measurements.

10 And I think that relates to my

11 final point, which is that I think there's a

12 fair amount of sexual dimorphism in lead's

13 effects both in terms of biokinetics as well

14 as health effects, which is not as

15 consistently addressed in this document as I

16 think it should be.

17 And that relates both to the nature

18 of bone lead measures in women versus men are

19 quite different, and also that in Section 4.3

20 there's some description of the age

21 relationship, the relationship of age with

22 bone lead that uses the Normative Aging Study,

Page 193

1 which is obviously a very important study

2 that's contributed a lot to our understanding

3 of the field.

4 But it needs to be acknowledged

5 that the Normative Aging Study is all male,

6 and what we know about the relationship of

7 bone lead to age in women is probably quite

8 different.

9 And so I think it's important that

10 there be, and this is one example, but I think

11 this happens in other parts of the manuscript

12 as well, or the final document, that being

13 sure that the limitations of the information

14 that are being presented are explicitly

15 acknowledged.

16 And that in this case that

17 limitations of information that's

18 predominantly or exclusively in a male

19 population, and the NAS is cited a lot in the

20 document, may or may not apply to women which

21 represent a big portion of the population, and

22 that that needs to be at least acknowledged. 
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1 There may not be as much data in

2 women, but I think the data that we have

3 suggests that there are going to be

4 differences, and that that's an important part

5 of understanding the health literature that's

6 not as clear as it could be.

7 So that was my comment.

8 DR. FREY: Okay, thank you. Great. 

9 Dr. Hays?

10 DR. HAYS: Thank you. So Joel,

11 I'll give you the, what was the term,

12 controversy, that you thought we'd be lacking

13 in this section, or in this charge question.

14 I'll preface my comments by saying

15 that I actually lobbied Aaron pretty hard to

16 let me out of this review. And he was a

17 convincing persuader to make me stay in,

18 because when I thought about this review I

19 thought, what could possibly be new since we

20 just finished the last lead CASAC?

21 So actually I like the organization

22 of the ISA and the fact that you're just

Page 195

1 dealing with what information is new, and in

2 particular Chapter 4 is really good with

3 respect to that.

4 Having said that, when I started

5 reading the section on lead biomarkers I

6 thought well, now what could be new in the

7 lead biomarkers world that could be needing to

8 be added to this ISA document to let us know

9 what is new and important to consider for the

10 next, starting the next NAAQS?

11 As I started getting through it I

12 actually started to think, see what I thought

13 the motivation behind putting this section in

14 was.

15 And that is, in the last NAAQS

16 review, terms about blood leads being used

17 like concurrent, lifetime average, integrated,

18 lifetime maximum, dose measures, all of these

19 were kind of being thrown out there with I

20 thought little understanding of what they

21 actually meant.

22 So I actually liked the section and

Page 196

1 I actually like these graphs -- Susan, sorry

2 to contradict you on this -- because it helps

3 to show those relationships between lifetime

4 maximum, concurrent, integrated exposures,

5 blood versus bone and such like that.

6 So I thought it was actually a good

7 exercise, and I think I saw what the

8 motivation for adding it was in terms of

9 helping the epidemiology community to

10 understand kinetics, how bone and blood

11 interplay, how they would interplay with

12 respect to short term exposures over time.

13 And one of the other things that I

14 think we in the epidemiology and risk

15 assessment community have been pretty poor in

16 understanding is intraindividual variability

17 and lifetime profiles of exposures.

18 We're starting to understand that

19 a little bit with respect to short-lived

20 compounds like phthalates. We know that

21 within an individual your levels can vary by

22 a thousand-fold in a day, in an individual.

Page 197

1 Something like dioxin that has a

2 half-life of ten years, you don't expect that

3 kind of variation. What you have now is going

4 to be what you have in ten years pretty much.

5 Lead is in there in between. You

6 would expect some intraindividual variability

7 over time on the time scale of months to

8 years.

9 And so I think having these kinds

10 of graphs help the epidemiologists and the

11 risk assessment community appreciate that fact

12 that hey, we may be having short term

13 exposures here and that will impact our blood

14 lead levels and our bone lead levels and that

15 those interplay between the two needs to be

16 understood.

17 So actually I liked their section

18 and I liked the graphs and I liked the use of

19 the biokinetic models to help convey that

20 concept. And that's it for my comments.

21 DR. POUNDS: That's controversial?

22 (Laughter.)
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1 DR. HAYS: Well, sorry. I like to

2 contradict Susan.

3 DR. KORRICK: Put that way it's

4 fine. I think it's just important, I think

5 there should be some mention of where modeling

6 diverges from empiric data and what that

7 implies.

8 I think it needs to be a little

9 more explicitly reviewed.

10 DR. FREY: All right. Well, I know

11 Dr. Weitzman has been eager to make a comment,

12 and then Dr. Kosnett.

13 DR. WEITZMAN: I just have one I

14 think quick comment, which is variation on the

15 point that you raised. I just point out that

16 we have the same problem in assessing lifetime

17 exposure in children.

18 And whether or not a current

19 biomarker reflects a current exposure or

20 earlier exposure, that same issue applies

21 whether it's in research and regulation or in

22 the care of individual kids.

Page 199

1 DR. KOSNETT: Thanks. I wanted to

2 offer a few comments on this section about

3 biomarkers. And I'm still going through

4 Chapter 4, so I will have additional comments

5 at some points.

6 But, you know, in Chapter 2, which

7 is a summary which summarized some of Chapter

8 4, there is a statement in there and it said,

9 and I'll read it, it's on line 22.

10 It says, "Blood lead in adults is

11 typically more an index of recent exposures

12 then body burden." And I disagree with that

13 statement because I think that, well it

14 certainly needs qualification, let's put it

15 that way.

16 Because in a lot of the key studies

17 that have looked at the impact of long-term

18 cumulative lead exposure and its implications

19 for adults from environmental settings, like

20 the Normative Aging Study and the Baltimore

21 Memory Study are two, the blood lead

22 concentrations in those subjects were averaged

Page 200

1 about five. Five micrograms per deciliter. 

2 They were people in their 50's to 80's, let's

3 say.

4 And at the same time that those

5 people had blood leads of five on average, the

6 teenagers in the same point had blood leads

7 around one. If you look at, you know, the

8 NHANES Data.

9 And, you know, most and if you look

10 at current environmental exposure to the

11 general population, most of it is coming from

12 food and water. That's actually shown in

13 Table 4-1, which I'll also comment on.

14 So you have teenagers, you know,

15 eating more than anybody and -- well, most

16 people. Maybe not these days. Teenagers

17 certainly on a body weight basis, let's put it

18 that way, seem to consume the most and drink

19 the most. And, you know, their blood leads

20 are one-fourth the values of people who are in

21 their 50's, 60's and 70's, at least there's

22 some suggestion.

Page 201

1 Some of the studies might be

2 different. The bottom line is, those blood

3 leads in those adults are not reflecting

4 contemporary exposure. They're reflecting the

5 accumulated body burden of lead that came from

6 these folks, who are in their 50's, 60's, and

7 70's who grew up and spent most of their lives

8 prior to the dramatic decline in lead exposure

9 that occurred in the 1980s.

10 Now the implication for this, for

11 the document is very, very substantial. And

12 this goes on to some comments I have on

13 Chapter 5. Because in a lot of places, in

14 discussing the health effects, it implies that

15 blood leads in the range of, you know, two, or

16 three, or four are associated with like renal

17 outcomes, or cardiovascular outcomes, or a

18 number of things.

19 And that is, yes, in that

20 population that was studied at that time,

21 there was associations between the blood lead,

22 but it doesn't reflect their long-term
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1 cumulative exposure, which was much higher

2 because most of these folks spent, had lead

3 exposure in the ten to 20 range, or ten to 25

4 range.

5 So anyway, I think that this

6 statement and to the extent that it's

7 reflected elsewhere in Chapter 4, and I don't

8 have the page number, I'm going to have to --

9 it really, I would suggest it be revised to

10 acknowledge the fact that actually in adults

11 today, you're blood lead is highly dependent

12 on your age, and that is highly dependent on

13 your past cumulative lead exposure.

14 And so I think, to say that blood

15 lead just reflects recent exposure is a

16 mistake, with all due respect.

17 Okay, and then with respect to the

18 biomarker issue, another -- I also want along

19 the lines of what Susan was saying about the

20 models. If you turn to that model, Page 4-49,

21 you know, it shows a very, it depicts a very

22 rapid decline in blood lead.

Page 203

1 And there's a statement on Page 4-

2 48 that says, "Based on this hypothetical

3 simulation, a blood lead concentration

4 measured one year following cessation of a

5 period of increased lead uptake, which show

6 little or no appreciable change from prior to

7 the exposure event. Whereas the body burden

8 would remain elevated."

9 That, you know, may be potentially

10 true to this isolated inputs to this model,

11 but I tell you, there was, you know, there was

12 a three-fold increase, or a four-fold increase

13 in blood lead between ages 30 to 50, going

14 from two to eight.

15 And then you say within a year it

16 goes back to two, I can not really -- I'm very

17 troubled by that observation. Because I can

18 tell you that if we put, you know, for people

19 in the workforce who had levels in ten to 15

20 range of blood lead, or 20 range, and they

21 worked for 30 years at that level, they are

22 not going to have the same blood lead a year

Page 204

1 later as people who never worked.

2 So maybe this is a -- this rapid

3 decline only applies with blood leads going to

4 two to eight, but as a general statement to

5 have the narrative suggest that within a year,

6 after 30 years of exposure, your blood lead is

7 the same as it was before your exposure, even

8 when that exposure increased by a magnitude of

9 three or four-fold, is just not what we see,

10 and not what we observed. Go ahead.

11 DR. WEITZMAN: Let me see if I can

12 clarify what you just said. But you describe

13 data that you're familiar with from workers

14 who have been exposed for 20 to 30 years. And

15 in that case their body burden's quite huge,

16 and so you wouldn't expect them to come back

17 down to baseline really rapidly.

18 And what this is, is a very short19 term exposure of less than five years.

20 DR. KOSNETT: No, it's 20 years.

21 DR. WEITZMAN: No. This is the, oh

22 right.

Page 205

1 DR. KOSNETT: It's 20 years.

2 DR. WEITZMAN: Okay, got you,

3 sorry, never mind. My bad.

4 DR. KOSNETT: Okay. I mean it

5 might be -- this simulation may show that if

6 you only go from two to eight, maybe there's

7 not enough.

8 But I don't want the take-home

9 message of the document to be that your blood

10 lead falls within a year to baseline, to how

11 it was after 20 years of higher exposure. 

12 Because I know a lot of settings where that's

13 not the case. And I think you --

14 DR. KORRICK: That's exactly what

15 I was trying to say as well.

16 DR. KOSNETT: Okay. And I had a

17 couple of comments on 4C, but I'll, those are

18 my comments on 4.

19 DR. FREY: Okay. All right, great,

20 well thank you. Other comments on 4B? Okay. 

21 Well I think we -- maybe I can take a little

22 crack at what at what I think I heard.
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1 I think Dr. Pounds has some

2 comments about terminology and the need for

3 consistency in the use of that terminology,

4 which seems like an important point that needs

5 to carry forward.

6 And we had a lot of discussion

7 about the modeling, and we just touched on it

8 again, so that's clearly an important theme

9 and response to charge question, 4 b.

10 I think there were also some

11 comments about differences by gender and age

12 that might need more discussion in terms of

13 biomarkers.

14 Are there other key points that the

15 discussants, just want to make sure kind of in

16 the high level summary, does that capture most

17 of it or are there other things you think are

18 kind of the top level key points for EPA.

19 DR. KORRICK: Did you mention

20 measurement error, or do you think that's not

21 as --

22 DR. FREY: Certainly, that's what

Page 207

1 I wrote down too. So measurement errors as

2 well. Okay. Well it seems like we've

3 probably addressed that for the moment. So

4 why don't we move on then to -- I don't have

5 my agenda in front of me, 4 c.

6 So 4 c, is Dr. Goodrum, Dr. Hays,

7 and Dr. Pounds, and we'll start with Dr.

8 Goodrum. And this is on empirical modeling.

9 DR. GOODRUM: Thank you. So this

10 Section 4.5.1, was air lead, blood lead

11 relationships. It's about eight ages, and it

12 introduces about eight studies I think, I

13 count here for child populations, and one for

14 adult.

15 And I had some specific questions

16 and then a suggestion overall for how to maybe

17 reframe this section. Overall I thought it

18 was really useful the way the Table was put

19 together and there were brief discussions that

20 accompanied each of the sections.

21 Where I think the reader may pause

22 a little bit is in understanding the

Page 208

1 significance of the slope factors that are

2 presented, which is really what the goal I

3 think is here, of laying out what each of the

4 studies might support in terms of blood lead,

5 air lead ratio, and why those might differ.

6 And to explain a little bit about,

7 to at least introduce the idea that there are

8 difference mathematical models that are used,

9 and that might explain in part some of the

10 differences.

11 So I think all of those concepts

12 came across well, but just a few specifics. 

13 It actually starts off by reviewing a

14 Brunekreef, et al. '84, document which was a

15 review document of other studies.

16 And does so to introduce or give an

17 opportunity to introduce a calculation of a

18 slope factor. So I think that's helpful. 

19 There is one typographical error which is

20 important, because it may carry through this

21 Section, would be worth doing some just double

22 checking.

Page 209

1 On Page 479 in that first

2 paragraph, it talks about what the slope

3 factor might be a you move from an air

4 concentration of .15 to 1.5 micrograms per

5 cubic meter.

6 When in fact the study really gives

7 that example with 0.5 to 1.5. And of course

8 that will make a big difference in terms of

9 trying to reproduce that number. It's not

10 reproducible at .15, so I'm quite sure that

11 was not intended.

12 The table itself I think would

13 benefit by reorienting it, landscape and then

14 expanding just a bit the descriptions of the

15 models. Right now there's a lot of

16 information packed into the third column on

17 Model Description.

18 But it's actually missing two

19 pieces of information that I would look for in

20 order to reproduce some results. And that

21 would just simply be the parameters that go

22 along with the model.
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1 So for example, if you have a log

2 log fit, you'd be looking for both the slope

3 and the intercept. So if you orient it

4 landscape you'll have a little more room. I

5 know you're probably down to about 7 point

6 font here.

7 The other thing that I thought

8 would be worth revisiting is the very last

9 column which is important, because it's the

10 summary information that's being provided that

11 the reader's being pointed to.

12 And this is, you know, look at the

13 range of slope factors that are generated

14 across these studies, and also understand that

15 that slope factor may vary in these non-linear

16 models depending on where you're looking at in

17 the change of errors. That's a very important

18 concept.

19 I actually couldn't reproduce

20 though some of these numbers the way they were

21 presented. So I believe the footnotes right

22 now say that, at a specific concentration of

Page 211

1 .15 and one microgram per cubic meter, this is

2 what the slope factor would be.

3 But just as an example of

4 Brunekreef, you actually need to present some

5 interval, I think change in order to describe

6 what that slope factor is. So I wasn't able

7 to reproduce any of those numbers, or trace

8 them back to the original citations.

9 The overall suggestion that I would

10 have, just thinking about how might use this

11 information, then moving forward. So we

12 understand that because of the complexities

13 and the different studies, they measure

14 populations that had different blood lead

15 levels, and different air lead levels,

16 particularly acknowledging that the air lead

17 levels that the models were developed from

18 only in just a few cases overlap even the

19 existing standard of .15.

20 So we're really talking about a

21 series of models and slope factors for which

22 there mainly developed on kind of the upper

Page 212

1 end of what the air concentrations going to

2 be, and that has implications for the slope

3 factors.

4 So to avoid I think what is

5 ultimately a trap, because of the limitations

6 and the available data of declaring all of

7 these slope factors to be uncertain, would be

8 to recast this section as, you know, here's

9 supporting information that gives a variety of

10 slope factors. They're going to differ for

11 these different reasons and we understand

12 that. But for decision making it helpful to

13 understand that if you slope factors fall

14 within a certain range, that has implications

15 for what the change in the geometric mean and

16 geometric standard deviation blood lead would

17 be.

18 So I put together just a few

19 graphics to illustrate that. And I have one

20 multimedia presentation here. Okay, so just

21 three graphics. So I thought I would just

22 spend a minute, because these are in my

Page 213

1 comments in case they're not clear what I was

2 trying to suggest.

3 So on the x-axis here, this is just

4 again those series of slope factors. I chose

5 just to from one to nine. Some of those slope

6 factors go even higher. So this would be the

7 change in blood lead that you would expect per

8 increment or per one microgram per cubic meter

9 change in the air standard.

10 So if we think about the fact that

11 we're at .15 right now, of course we can't

12 change by one, we're going to change by some

13 small increment of one, so it's helpful to

14 recognize that as we evaluate potential

15 alternative standards.

16 Maybe more conservative standards

17 going from .15 and in this case to .10, this

18 is what the implication would be based on

19 these different slope factors.

20 And so the y-axis just tells you of

21 the blood lead distribution statistics. 

22 You've got two lines here assuming it's log
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1 normal with a GSD of 1.6, the slope factors

2 will translate into a incremental change in

3 your geometric mean below .5 micrograms per

4 deciliter, and then at the 95th percentile

5 below one. So that maybe helpful to

6 understand.

7 And then you can do the same

8 exercise again for alternative metrics. So if

9 you can go down to Figures 2 and 3.

10 So Figure 2 is the exact same

11 exercise, but this time going from .15 to .05,

12 and you can see now we've got a slightly

13 larger change that we're asking you to

14 evaluate. And the corresponding changes in

15 blood lead get higher.

16 And then I just ran one more going

17 from .5 to .015, so in order of magnitude

18 difference. So just for clarification, the y19 axis isn't the predicted blood lead

20 distribution, it's just the change that we

21 would expect given the slope of the

22 empirically derived slope factors that fall

Page 215

1 within these ranges.

2 This would be the change in the

3 geometric mean above and beyond baseline,

4 above and beyond the other contributions. So

5 this may, to the extent that these models are

6 predictive and, you know, you need to look at

7 the R-squares, and understand sample size and

8 all of those things.

9 This gives you some way of kind of

10 framing, you know, how these data, and then as

11 additional reviews happen, as you collect more

12 data down the road, it may or may not fall

13 within these ranges.

14 DR. KOSNETT: So this is in

15 children?

16 DR. GOODRUM: This is, well you

17 could look at alternative slope factors for

18 adults and run the same exercise.

19 DR. KOSNETT: Yes, but this is in

20 children using IUK?

21 DR. GOODRUM: No, this is just

22 simply using the assumption of a log normal

Page 216

1 distribution.

2 DR. KOSNETT: Oh, yes, got you.

3 DR. GOODRUM: Yes. So with an

4 incremental, because what we have with this

5 slope factors tells us that an incremental

6 change in air lead corresponds to an

7 incremental change in blood lead.

8 DR. KOSNETT: Right. I got you.

9 DR. GOODRUM: The other point as I

10 was trying to put this exercise together,

11 you'll see, I assume that the ratio that was

12 referred to here was the geometric mean. And

13 that's worth clarifying.

14 And you can get wrapped around the 

15 x a little bit as you take log tranforms on

16 what actually, when you back-transform, you're

17 getting the ratio of. Is it the ratio of the

18 geometric mean? Or is it the ratio of the

19 arithmetic mean blood lead. And so I don't

20 have anything definitive to say because I

21 didn't seriously investigate each of the

22 primary studies.

Page 217

1 But I would just encourage you to

2 go back and really make clear whether you're

3 talking about the ratio based on the change in

4 the geometric mean or the arithmetic mean,

5 because of course that has implications for

6 these hypothetical log normal distributions.

7 And it's probably worth even having

8 a description, a section short enough you

9 could have a paragraph description just

10 pointing out that in some cases, these studies

11 may be more representative of an predicted

12 arithmetic mean change in the population

13 rather than geometric mean change. And Chris,

14 I think that's it.

15 DR. FREY: Okay. Great, thank you

16 very much. Let's see Dr. Hays.

17 DR. HAYS: I actually like Section

18 4.5, it was nice to see more blood versus air

19 correlations. In that last NAAQS, we kind of,

20 instead of like in the 11th hour switched to

21 the empirical model over the IEUBK model, and

22 I think we had one may slope factor, maybe two
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1 that we relied on. So it was nice to see more

2 put into this document.

3 What I'd like to see is how the

4 results from these other slope factors compare

5 to the one that was relied upon for the last

6 NAAQS to see how that difference might be

7 between the previous approach and these

8 models.

9 The other thing that struck me was

10 that, what would be very helpful is to take

11 Table 4-11, and convert it into a figure in

12 which you plot the slopes of these lines,

13 blood lead versus air lead, and only show the

14 line for which the air concentrations were

15 valid for that study.

16 And show how they all compare

17 across each other on a linear linear scale, on

18 a log log scale, on a log linear scale,

19 however you want to do it. I know it's hard

20 because they're going to be all over the

21 place.

22 But show what air ranges their

Page 219

1 relevant for, their applicable for, because

2 these kinds of correlations really start

3 getting wacky on the tails. And when you

4 start trying to extrapolate, especially down

5 to these lower regions, a lot of these

6 correlations are not valid.

7 And so, you know, make that

8 apparent through a figure to show where

9 they're applicable for and where they're not. 

10 And it may be that none of them are applicable

11 for the range at which we're considering for

12 the NAAQS here between .15 and 1.5. But that

13 needs to be made very apparent and

14 transparent.

15 The other thing is you could code

16 those by the factors that Phil mentioned. For

17 instance, whether the ambient air was a

18 function of the exposure type, like was it a

19 smelter community? Was it a urban community? 

20 Was it a gasoline phaseout population study?

21 All of those are going to have very

22 different exposure characteristics and that

Page 220

1 may help explain the difference between them. 

2 And the particle size for the air sample

3 collections because that definitely would have

4 an impact as well.

5 I had another comment on an earlier

6 section of Chapter 4, and maybe I should've

7 said something in the discussion of 4 a.

8 But one of the things I've been

9 frustrated by in the last NAAQS and this NAAQS

10 as well, or this discussion as well is that

11 it's not east to tell from these exposure

12 chapters how much of a role air plays in the

13 given blood lead levels that we're

14 experiencing in the U.S. today.

15 What is it contributing? Is it

16 five percent, is it 30 percent, is it 50

17 percent, is it 70 percent, what is it?

18 You know, I'd love to see a pie

19 chart that says for a given blood lead of one

20 micrograms per deciliter, five percent is due

21 to air, 30 percent is due to diet, 40 percent

22 is due to water, whatever that is, I'd love to

Page 221

1 see that.

2 And how does that change as a

3 function of blood lead. And maybe that's too

4 simplistic. And I know it's hard because lead

5 is such a multimedia contaminant and, you

6 know, I'm going to be with Philip on this one.

7 You know, maybe lead doesn't need

8 to be in the NAAQS anymore, because it's just

9 so multimedia and I think air is playing such

10 a minor role now.

11 But I'd love to see that in this

12 exposure chapter. What role does air play for

13 the given blood leads we're experiencing, and

14 as a function of blood leads.

15 Is it that the higher exposure kids

16 that have, or adults that have leads of five,

17 that all of sudden air's becoming a more

18 important player there.

19 Or is it the opposite, that it

20 really has no role whatsoever at those higher

21 levels. Is it all just dust, or diet at that

22 level. So that's it, that's my comments.
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1 DR. FREY: Okay, thank you. Dr.

2 Pounds?

3 DR. POUNDS: This was an easy

4 section to read like the rest of Chapter 4,

5 and my comments are editorial.

6 DR. FREY: Okay. All right, great. 

7 Well then that opens us up to other members of

8 the panel on Charge Question 4c. Yes, Dr.

9 Kosnett?

10 DR. KOSNETT: I had a question or

11 a comment on the section about the air

12 lead/blood lead relationships, you know, which

13 is really very critical to this whole

14 exercise.

15 And when I read the summary in this

16 section, which I guess is on, what page is

17 that on? Well the page that summarizes the

18 relationships between blood lead and air lead. 

19 Maybe it was --

20 PARTICIPANT: It's towards the

21 back.

22 DR. KOSNETT: Yes, it's on Page 4-

Page 223

1 97.

2 PARTICIPANT: Yes.

3 DR. KOSNETT: I think it would be

4 helpful for the EPA for this section, to try

5 to do a more critical analysis of which of

6 these slopes, bears the most evidence, you

7 know, or what's most relevant to the levels

8 that we're facing.

9 Because Phil, what you just showed,

10 now I understand it. I was off on -- I don't

11 know why I missed that first point, but now I

12 see what you said. I mean you really

13 basically showed how for a different magnitude

14 of air reduction, you'll get a change in blood

15 lead.

16 And depending on the slope, there's

17 a substantial difference. So the key question

18 that emerges, which is the right slope?

19 DR. GOODRUM: Or what range of

20 slopes are represented.

21 DR. KOSNETT: Or which range of

22 slopes are representative, and I hope, I don't

Page 224

1 know the answer to that.

2 But I hope if you can potentially

3 take this Section 4-7.4 which is on 4-97, it

4 doesn't really give me, you know, when you're

5 finished reading that you don't come away with

6 an opinion as to what, it's not like a

7 critical analysis of what do you think. And

8 to the extent you can help us with that, I

9 think that is very important.

10 You know, you say that some of the

11 differences might reflect model selection by

12 the investigators. Maybe you can run

13 different models and diagnostics, you've got

14 the world's expert over here, Dr. Rothenberg

15 (phonetic) on that, on looking at models and

16 diagnostics, and things like that. It would

17 be helpful to do that.

18 Then I had another question and it

19 kind of, or a point, it kind of follows what

20 Sean just said, and that is, the issue of the

21 contribution of air lead to food.

22 You know, I was really struck, it's

Page 225

1 very interesting when you look at Table 4-1,

2 can you put that up? It's on Page 4, is it 4-

3 4? Yes, Page 4-4. If you can put it on that,

4 oh, I don't know.

5 If you look at the relationship

6 between, it's a table that's interesting

7 because it basically shows the contributions

8 to humans of lead from various sources.

9 And I don't know, I'm curious if

10 this is the best data and the most recent data

11 that exists. It very well may be. I mean I

12 know that back in the 80s, the average blood

13 lead estimate in the United States was quite

14 a bit higher than about ten, I guess I think

15 closer to 30, or 40, or 50, in that range.

16 But what you see here is that by

17 far, by far for the average person, I'm not

18 talking about a child living in a, you know,

19 with leaden dust, but by far for the average

20 person, it's dominated by lead in food and

21 beverage intake. It's estimated to be ten

22 micrograms per day.
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1 If you look at the air levels

2 there, at the top and you multiply them by,

3 like an adult breathing in 20 cubic meters a

4 day, that's about right, right? You know, you

5 get .3 micrograms, or point, yes about .3

6 micrograms at the medium, or .4 micrograms,

7 compared to ten micrograms in food and diet.

8 So diet, it's like extremely

9 important. So the question that emerges, how

10 did that lead get into the food and beverages,

11 you know?

12 And some of that is probably a

13 consequence of the fact that air lead, you

14 know, gets into the ground and into the food

15 supply ultimately. And long-term will

16 influence, you know, what that number is.

17 And I'm just curious, and I don't

18 know that the document really addresses this

19 or answers it, but I think it has policy

20 implications.

21 If the average person is getting

22 about ten micrograms a day, ten to 12

Page 227

1 micrograms a day, let's say, or ten micrograms

2 a day. And the average blood lead in the

3 United States now is about 1.5 micrograms per

4 deciliter.

5 If we cut our air lead emissions

6 any further or we change the standard, will

7 that number go down? This is the kind of

8 thing that you were raising Sean.

9 Because that number, that ten is

10 what's driving most of the blood lead in the

11 United States today for the average American.

12 And I'm just curious, how much

13 would that number go down, even if it's not in

14 the short-term, but if it's in the long-term. 

15 Now I notice tomorrow we're talking about the

16 modeling with recent lead and then past lead.

17 And unfortunately for the various

18 limitations, you don't look, you just

19 consider, you don't consider the effect of air

20 on food and water, you consider that

21 background.

22 And we're not modeling that in our

Page 228

1 exercises. And I understand the difficulty,

2 at least in the short run. But I'm just

3 wondering in the long run, if anything we do

4 to air going to change that ten.

5 Because that ten micrograms a day

6 is what's keeping most of us with a blood

7 lead, well those of us under 50 maybe. The

8 younger people among us are keeping the blood

9 leads of, you know, one to two.

10 And until we lower that ten, we're

11 not going to get much lower than that. And

12 I'm just wondering, does air have an influence

13 on that. And I don't know the answer, and I

14 wish the document could shed light on that to

15 a certain extent. Because I think that from

16 a policy perspective, that's a very important

17 question. That was my comment.

18 DR. FREY: Okay, great. Other

19 comments on 4c, or 4 more generally? Okay.

20 DR. von LINDERN: This has helped me

21 to organize some of my thoughts. I thought

22 those were great comments.

Page 229

1 DR. FREY: Can you use the

2 microphone, please?

3 DR. von LINDERN: The pie chart

4 part though, that is going to vary by every

5 situation in the country as to how much is

6 relative to air, relative to the other

7 sources. And the food certainly plays into it

8 big.

9 I guess part of what bothers me is

10 we don't know what those situations are in the

11 country. We're going to model a few of them

12 in this risk assessment process, but how do

13 those apply across the U.S.

14 So I'd love to see what you want

15 Sean, but I think we can only get it probably

16 from these modeling exercises, and they're

17 hypothetical. And we do have a major data gap

18 in how applicable are those hypothetical

19 situations we're going to model to the overall

20 situation in the country.

21 And then the one other thing you

22 have to throw in is that it's not only by
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1 site, but it's by population. Because there

2 may be specific populations that have

3 different ingestion patterns that will

4 influence that as well.

5 DR. FREY: Okay. Just looking at

6 the clock we're a little bit behind schedule. 

7 So I would propose to move onto the next set

8 of Charge questions on number 5.

9 And there are five subparts which

10 we've grouped into three categories. The

11 first category is 5a and 5e, which relates to

12 modes of action and dose response, and those

13 seem somewhat related to group them together.

14 So the discussants for that are Dr.

15 Cory-Slechta, and Dr. Hays, and of course, Dr.

16 Canfield couldn't be here, and he was another

17 one of the assigned discussants. So I'd like

18 to turn the floor over to Dr. Cory-Slechta on

19 5a and 5e.

20 DR. CORY-SLECHTA: Okay. I'm going

21 to make some comments first about the mode of

22 action, which I thought was a great addition

Page 231

1 to the document. And I thought it was

2 generally pretty clearly written. I have a

3 few specific things I think need to be talked

4 about.

5 One are studies on oxidative

6 stress, and these are cited throughout the

7 document and they're cited in the mode of

8 action. Unfortunately, the studies aren't

9 really described in enough detail, at least to

10 the reader to come to the conclusion that

11 you're really reducing or reversing oxidative

12 stress.

13 Because one of the things that

14 could be going on and is not really discussed

15 in this section, is whether or not the agents

16 that are being given, and I don't know what

17 the time frames of all of these were, what the

18 specific design was. Are they altering

19 toxicokinetics?

20 So to me if something is simply

21 blocking the uptake of lead, and thereby,

22 reducing the level of oxidative stress, that's

Page 232

1 just changing the dose of lead so to speak.

2 I don't consider that to be

3 essentially a mechanistic study showing

4 oxidative stress is reversing an effect. And

5 there are lots and lots of descriptions of

6 studies in there that I couldn't interpret as

7 necessarily reversing oxidative stress.

8 Because the designs are not spelled

9 out enough. If you've given lead exposure,

10 generated oxidative stress, and then give

11 something that reduces it that's one design

12 where I can see that.

13 But unless you can show me that it

14 didn't change the uptake, or the blood lead,

15 or the brain lead concentration, I don't

16 necessarily know that it was working by

17 reducing oxidative stress, per se, as opposed

18 to having a toxicokenetic influence.

19 So I think you have to be careful

20 about how you interpret that kind of data,

21 unless you look at the specific design.

22 One of the other things that

Page 233

1 troubled me reading this was there's a lot of

2 studies of in vitro lead exposures, which

3 clearly have their place. But there's lots,

4 and lots of descriptors in there of levels,

5 concentrations used with the phrase, "as low

6 as," and then saying things like one

7 micromolar, or five micromolar. I don't think

8 we even considered one micromolar to be low,

9 and even cases where it says, as low as five,

10 just kind of like, no.

11 So I would suggest deleting those

12 because they're not considered low. Or at

13 least deleting those and maybe putting them in

14 some kind of context.

15 So I think what's really hard,

16 especially for somebody who doesn't know that

17 literature, is to try to relate in vitro

18 exposures to in vivo, what is that? Can you

19 provide some kind of a scale?

20 And I say this recognizing that

21 these are really supportive more than anything

22 else. But they feature prominently in the
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1 mode of action section. So I think that

2 deserves some consideration.

3 I think one thing that doesn't

4 belong in this document, and I think we'd all

5 agree is never going to happen, there are

6 statements made and they're not necessarily in

7 the mode of action, they're in other sections

8 as well.

9 Based on biochemical changes, I

10 think one of them related to synaptic

11 plasticity, I can't remember what. Suggesting

12 that as I remember, glutamatergic angonist, or

13 antagonist, or something might be used

14 therapeutically for lead.

15 I can't imagine anybody would ever

16 think about using compounds like that in low

17 blood lead levels, not even maybe high blood

18 lead levels. And I just don't think they

19 belong in the document.

20 So I think anything therapeutically

21 that's based on some biochemical or molecular

22 site, and come back and talk about kelation,

Page 235

1 probably doesn't belong in the document. 

2 Kelation is a different issue. Which actually

3 isn't talked about all that much, but I'm not

4 sure that it belongs here anyway. So those

5 will be my statements about the mode of

6 action.

7 With respect to the dose response,

8 I think the non-linear nature has clearly been

9 supported by a lot of additional data that has

10 come out since 2006. I don't have any quibble

11 with that.

12 In reference to some comments that

13 were made earlier in the day, it's clear that

14 not all studies are going to be able to

15 demonstrate that non-linearity. Because first

16 of all, they're going to have very different

17 power in terms of detecting effects.

18 And secondly, one thing that kind

19 of gets left off the table here, they use

20 different endpoints. And those endpoints

21 differ in their sensitivity and ability to

22 pick up those kinds of effects.

Page 236

1 So, you know, even something like

2 IQ. If you have an average IQ in a population

3 that's 70 or 75, how much lower can you go as

4 opposed to starting out at 90 or 100. So you

5 already have a floor effect.

6 But I think we need to remember

7 that not every study is going to have the

8 ability to detect those kinds of effects. So

9 for 5a and e, I'll stop there.

10 DR. FREY: Okay, thank you. Let's

11 see, Dr. Hays?

12 DR. HAYS: My comments are pretty

13 brief on these two Charge questions. With

14 respect to the mode of action question, unlike

15 Chapter 4, this chapter kind of seemed to

16 review the scope of the world with respect to

17 mode of action.

18 And I didn't get a good

19 understanding as to why that was necessary, as

20 opposed to what was just new. Maybe you had

21 objectives that just weren't spelled out

22 clearly.

Page 237

1 In particular, Table 5-2. If you

2 look at that table, one of the things that

3 struck me is that, I don't know if you can

4 bring that up?

5 PARTICIPANT: 541.

6 DR. HAYS: 541?

7 PARTICIPANT: Yes.

8 DR. HAYS: Thank you. Let me get

9 there myself. It appears from this table that

10 all effects associated with lead, ranging from

11 altered ion status to cell death and

12 genotoxicity are equally potent. Are equally

13 potent. And I don't think we think that from

14 the toxicology perspective.

15 Not all those are equally potent

16 outcomes associated with lead toxicity, so I

17 think this Table is pretty misleading. You

18 need to include more information if you want

19 to try to compare the potencies of these

20 various endpoints.

21 (Off the record comments.)

22 With respect to the non-linear
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1 section, I actually really liked this section. 

2 The discussion about the dose response

3 relationship between blood lead and IQ deficit

4 in children.

5 And in particular, Lanphear Study,

6 and debating whether it was log linear or

7 linear linear or piecewise linear, was a big

8 debate in the last NAAQS. And so I think this

9 section actually helped me because I was one

10 of the doubters of that log linear dose

11 response relationship.

12 And so having other lines of

13 evidence that could help explain that

14 relationship was helpful for me, so I

15 appreciated that and I liked that section. 

16 That's it for my comments.

17 DR. FREY: Yes, go ahead.

18 DR. CORY-SLECHTA: I just want to

19 follow-up on one thing I think Sean just said,

20 and this belongs in the section on integration

21 as well. But one of the things I always

22 struggle with because I do both human and

Page 239

1 animal work is the human folks are always

2 looking for some direct correlation in the

3 animal literature of a non-linear slope, to

4 what you see in humans.

5 But physiology doesn't work that

6 way as we all know. And I think it would be

7 really useful to in fact, state that. That,

8 you know, we have huge amounts of evidence of

9 non-linear dose effect curves in the tox

10 literature.

11 There not necessarily going to look

12 exactly like the non-linear slope in IQ. 

13 Because they don't directly translate, and

14 they wouldn't reflect human physiology if they

15 did.

16 So I think it would be really

17 useful to put that in there, and maybe start

18 getting this point across.

19 DR. FREY: Great, thank you. I'm

20 tempted to maybe just go forward with the lead

21 discussants on all subparts of 5, and then

22 come back to the panel. Would anyone object

Page 240

1 to that? I think it might --

2 DR. CORY-SLECHTA: Well then do you

3 want us to go through? I have comments. Do

4 you want us to just go through them?

5 DR. FREY: Well I'm mindful that

6 we're a bit behind schedule. So what I want

7 to do is go with the lead discussants on 5b

8 and 5c, and then on 5d, and then we can come

9 back and discuss anything we didn't otherwise

10 catch. So on 5b, and 5c, Doctors Kosnett, and

11 Wasserman. Dr. Kosnett?

12 DR. KOSNETT: One of the key

13 Charges to 5b is, does the ISA adequately

14 describe the evidence with regard to the range

15 of exposure concentrations, and/or blood or

16 bone levels associated with the identified

17 endpoints. All right.

18 And I think that the document, in

19 some places doesn't do that adequately. For

20 the reason being, that it attributes certain

21 blood lead concentrations less than five,

22 maybe on the order of two or three blood lead

Page 241

1 concentrations, two micrograms or whatever, to

2 being sufficient to cause some of the

3 endpoints that have been observed based on

4 certain studies.

5 Let me be more specific. There's

6 evidence in certain studies, like some of the

7 NHANES studies that if you have a blood lead

8 going from two, to three, to four, like Dr.

9 Muntner's studies, that you increase

10 cardiovascular mortality.

11 Okay, that's observed yes, in that

12 study but the implication that if you just had

13 for your whole life a blood lead concentration

14 that went from two to four, that you would

15 have, you know, 20 or 30 percent increase in

16 cardiovascular mortality can't be devined from

17 Muntner's studies because those are conducted

18 in people who are middle-aged to older for the

19 most part. I mean if the NHANES, you realize

20 the NHANES population, half of them were born

21 before 1950, in the NHANES database.

22 So these people may have blood lead
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1 concentrations of two, or three, or four now,

2 but that doesn't mean that a blood lead

3 concentration of two, or three, or four is

4 sufficient to have caused them to have this

5 increase in mortality. And I think the

6 document would benefit by highlighting that.

7 Similar thing occurs in the renal

8 section as well. And it applies basically to

9 almost the endpoints as they apply to adults. 

10 Because a lot of the effects that have

11 occurred that we're witnessing in adults, are

12 associated with cumulative lead exposure, that

13 includes substantially higher blood leads. 

14 Even not withstanding the fact that right now

15 the blood leads are low.

16 I think that was recognized well in

17 the document we're going to talk about

18 tomorrow. But I don't think it was as clearly

19 specified or spelled out in this chapter.

20 And, you know, if you look at the

21 tables, some of the tables, you know, talk

22 about changes in blood pressure, or changes in

Page 243

1 renal function at, you know, one microgram per

2 deciliter.

3 But the problem with that is the

4 data don't show that if you just had exposure

5 that can find you to having blood leads of one

6 or two, that you would see those effects.

7 I hope I'm not repeating myself,

8 but I think is a major concern that I had with

9 respect to how the range of effects were

10 presented.

11 DR. FREY: Okay. Was that it for

12 5?

13 DR. KOSNETT: For 5b, yes.

14 DR. FREY: Okay, and 5c? I think

15 we're talking about 5b and c. Did you have

16 comments on c?

17 DR. KOSNETT: Should we expand the

18 endpoints? No, I think you covered the

19 waterfront on the endpoints.

20 DR. FREY: All right, Dr.

21 Wasserman?

22 DR. WASSERMAN: I'm speaking mostly

Page 244

1 about the effects on neurocognitive outcomes,

2 but I think this is true of other outcomes.

3 Throughout this chapter it's not

4 really clear what the clinical significance of

5 the effect sizes that we're talking about

6 might be. And this is really the case for,

7 certainly clearly the case for the -- like the

8 IQ effects.

9 If we're talking about a point or

10 a half a point, or a third of a point, that's

11 something that's really just not going to be

12 of any -- much clinical significance.

13 So we need to have some sense of

14 how much of an effect, whether it's in the

15 renal system or the neurocognitive system, is

16 meaningful from a clinical standpoint.

17 If you keep in mind, maybe some

18 discussion then of the metrics of IQ

19 assessment is important to keep in mind if

20 you've got a standard error of measurement and

21 an IQ test of five points.

22 Which means if I assessed the same

Page 245

1 child twice over two days with the same,

2 pretty much the same test, and the same child,

3 and the same investigator, I could get a score

4 that's five points different.

5 So it means that the one or two

6 point difference is not really discernable in

7 terms of walking around skills that we would

8 see in a child.

9 And I think while we can identify

10 yes, there is this effect, if you're going to

11 translate this into policy, ultimately what is

12 the added value of reductions down at this

13 level, has to be taken into some

14 consideration.

15 And I think there's some mention

16 here in this section, but it gets more

17 specifically, the case with some of the other

18 documents that spin off this Chapter 5, when

19 we're talking about points lost being a half

20 an IQ point.

21 I mean as a psychologist I will

22 tell you that it makes my skin crawl. There
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1 is no such thing as a half a point, a third of

2 point being lost, it doesn't get measured that

3 way.

4 I think that also the presentation

5 here, because there are so many health

6 outcomes, and I think certainly I wouldn't

7 want to expand their range.

8 I would really like to see some

9 cross-talk increased in terms of, these are

10 all presented as though we have sort of 30

11 independent outcomes. And the outcomes are

12 quite related in some regard.

13 And I'm not sure I understand how

14 they would be, but some discussion perhaps of

15 how we go from ion transfer differences to

16 then IQ points, would be useful. Or how the

17 cardiovascular effects might also reflect or

18 be captured by further downstream behavioral

19 and intellectual functions, would be useful.

20 And as a smaller note, even when

21 we're talking about the cognitive functions,

22 again, they're all presented as though they're

Page 247

1 at the same level. And some of these

2 obviously interrelate.

3 So that if we know we're going to

4 see a compromised intellectual function, if we

5 know we're going to see behavioral

6 disturbance, it should come as no surprise

7 that we're going to see academic difficulties

8 or grade achievement difficulties.

9 So these things all interrelate

10 with each other in some ways that really would

11 be useful to be described.

12 I think that it's important to,

13 where we know that there's things that need to

14 be, that there are confounders of the IQ

15 outcome -- the exposure outcome relationship.

16 It would be nice to be more consistent about

17 describing what those are, so that in some

18 instances the behavioral literature is

19 discussed and it's not clear to me whether or

20 not all of these papers are adjusting for

21 other things that might be important in that

22 relationship.

Page 248

1 Probably we don't want to mention

2 every single thing that everybody ever has

3 adjusted for, but some description of what

4 those might be, or what key features should

5 need to be held aside when looking at that

6 outcome, might be useful. So that the reader

7 can better evaluate the quality of all of

8 these things as they interrelate.

9 I have a semantic disagreement with

10 the use of the term neurological to describe

11 this entire section. These are really not

12 neurologic outcomes or they are, but they're

13 not only neurologic outcomes.

14 They really are nervous system,

15 central peripheral nervous system outcomes. 

16 Most of us don't publish in neurological

17 journals. These are neurobehavioral,

18 neuropsychological, neurocognitive, they're

19 more functional than they are structural. And

20 I know that's a carryover from earlier

21 documents, but these really are not, that's

22 just jarring me to read.

Page 249

1 Again, there's lots of examples of

2 places where I think the document would be

3 helpful in providing cross-talk. For example

4 the behavioral effects seem to be in one

5 domain for children, and a totally different

6 domain for adults. What does that mean?

7 Kids with increased blood leads

8 typically show increased, what we call

9 externalizing disorders, like acting out,

10 oppositional, impulsive behavior. Adults with

11 elevated levels, the most consistent report is

12 for mood disturbance and depression.

13 How is that possible? I can

14 speculate, but it might be at least important

15 to document or to say to the reader, we don't

16 know how we get from a to b, but effects are

17 very different across the lifespan. I think

18 it's important to make note of that.

19 What else? Let's see. Oh that,

20 the table that talks about specific indices of

21 cognitive function. There's my point that

22 many of these things are the components for
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1 the underlying substrate of what's there when

2 we look at IQ.

3 But also included in that table are

4 the studies of infant developmental outcomes,

5 the Bayley's Scores, which really aren't,

6 we're talking apples and oranges here.

7 These are not specific functions in

8 infants, they are sort of the developmental

9 equivalent of an IQ, but scaled down to

10 babies. So they don't really map really well

11 onto the other elements that are in that

12 table, Table 5-4.

13 And we know that early

14 developmental scores are far less stable over

15 time in terms of measuring IQ, so it's not a

16 surprise that the effect sizes look a little

17 bit different when we look at the Bayley's

18 scores then other indices of cognitive

19 function.

20 So again, I would be happy of there

21 was some way to have greater cross-talk to

22 explain how we get this wide range of, either

Page 251

1 the nervous system outcomes, or to go from one

2 kind of outcome to another, if that's

3 possible. And I had some specific comments,

4 but those are probably easier dealt with else

5 wise.

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

7 All right, let's go to 5d. And for this, the

8 lead discussants are Doctors Korrick, Cory9 Slechta, and Kosnett. So, start with Dr.

10 Korrick.

11 DR. KORRICK: Okay. I think

12 there's probably going to be some overlap in

13 this Section with the previous Charge

14 Question.

15 So I think, I'll focus I guess on

16 the balance between the toxicologic and

17 epidemiologic literature. And I think as a

18 sort of epiphenomenon, making sure that both

19 streams of knowledge are optimally presented.

20 I think it's very important to

21 they're being well integrated. And I have

22 some general comments on that issue and then

Page 252

1 some specific comments from my written

2 submission that I won't go into.

3 But I think, depending on the

4 particular health measure that's being looked

5 at in this section, I think some sections are

6 better than others at identifying and

7 prioritizing studies.

8 So there's a lot of tables that

9 indicate a long laundry list of studies in a

10 particular area and affect estimates. But the

11 text isn't always very helpful in

12 prioritizing, and I think that's an important

13 piece that needs to be in this Section.

14 Some of those studies have design

15 limitations that are pretty substantial, and

16 some are just inherently probably more

17 valuable, of longitudinal studies probably

18 better off than a case-control study, which is

19 better off than a case series.

20 And some studies can be better at

21 controlling for confounding than others. And

22 I think that degree of analysis in

Page 253

1 interpreting the literature is not

2 consistently represented in this Section.

3 And it's critical, because before

4 you can make inferences from this long laundry

5 list of studies, you need to be able to tease

6 out which information you think should be

7 given more weight, and understanding the

8 underlying conclusion.

9 And I think that's missing in a lot

10 of cases. And actually, specifically saying

11 that, you know, that the interpretation of

12 this body of literature is the following based

13 on the weight that we give to studies that we

14 feel are more robust. So that's one issue

15 that I think needs to be cleaned up a little

16 bit.

17 And then also I think sort in

18 keeping with that and apropos of my earlier

19 comments, oftentimes it looks as if there are

20 a large number of studies on a particular

21 topic, when in fact, a substantial portion of

22 what's presented is variations on analyses in
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1 one particular population.

2 Again, the Normative Aging Study is

3 a good example, or NHANES where most of our

4 knowledge on a particular area comes really

5 from only two types of studies.

6 And although, those studies have

7 done a lot of good work, again, I think

8 interpreting findings and interpreting the

9 weight of evidence, it's important to keep in

10 mind if evidence is coming from a relatively

11 limited set of studies, because that impacts

12 implications that can be made about robustness

13 and reproducibility.

14 And I think, so in terms of the

15 animal data, I'm not obviously an animal

16 person, but I think there are ways in which

17 analogous issues with presentation of

18 toxicologic data, both in vitro models as well

19 as animal models, that would help make the two

20 data streams more cohesive.

21 For example, I appreciate that the

22 way that animal dosing is done is very

Page 255

1 different than the way humans are typically

2 exposed. But where the animal dosing

3 component of an experiment can be explained in

4 a context that helps figure out how to relate

5 it to humans would be useful.

6 So for example, there are studies

7 in the neurological outcomes section that

8 expose animals to lead through direct

9 hippocampal injection. Well, you know, that's

10 really the interesting from perhaps a

11 mechanistic point of view, but it probably has

12 very little relationship to human exposure, if

13 not, you know, very limited.

14 And so how to interpret that as

15 this sort of evidence of neurologic effects

16 that help us understand health effects in

17 humans, is very problematic for me. And I

18 think there needs to be more critical

19 acknowledgment of that in the summaries of the

20 toxicological literature.

21 When you have direct hippocampal

22 injection, this may or may not be that

Page 256

1 relevant to our understanding of human studies

2 and not, you know, others who are animals,

3 experts I'll defer to, but I have a little

4 trouble with that.

5 I think the other thing that

6 happens is that the form of lead in the animal

7 studies seems to me potentially relevant, and

8 it's not discussed.

9 And again, I don't know if this is

10 not something that's typically done in animal

11 studies, but there are studies in the cancer

12 outcome section where lead chromate was used. 

13 And sure enough they saw cancer, but it was

14 probably related to the chromate.

15 And so I think, really thinking a

16 little more comprehensively about what we do

17 in animal studies, and what works and doesn't

18 work in terms of understanding human risk,

19 could improve the integration between the two

20 data streams a lot.

21 And sort of in keeping with that,

22 I think there are a number of sections in this

Page 257

1 Chapter in which there's a lot of information

2 about in vitro mechanistic studies, which is

3 very interesting.

4 And there are some section in which

5 in vitro findings are not consistent with in

6 vivo models, and there's no -- there was

7 rarely an acknowledgment of the fact that you

8 may see differences in an in vitro and an in

9 vivo model because they're very different

10 models.

11 And the implications of that were

12 not very explicitly acknowledged. And again,

13 I think that's really important to then

14 applying that information and integrating it

15 with the human data.

16 And I think the other thing along

17 that line is that, some of the animal studies

18 had outcomes, I realize you can't get complete

19 parity between outcomes in a rodent and

20 outcomes in humans. But I think it takes a

21 lot of work and it's worth the effort to try

22 to figure out where there are homologies is
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1 between what's being done in animals and

2 what's being done in humans.

3 And I didn't see that happening in

4 a lot of the sections. So in the neurologic

5 section there's a description of a rotarod

6 task and a rodent. And I'm not sure what that

7 means for humans if it's related to

8 Parkinson's Disease.

9 I mean I'm not sure what that

10 means, and it would have been helpful for me

11 as a non-animal person to have a better sense

12 of how important that might be in a human

13 setting.

14 I think the last sort of main issue

15 was, and this sort of gets back to my previous

16 comments about sexual dimorphism in both

17 toxicokinetics and toxicity is that, I think

18 one of the challenges in this chapter is how

19 to identify meaningful susceptibility factors.

20 And by meaningful I guess I mean

21 factors that would really impact how you think

22 about a risk assessment and populations that

Page 259

1 are at risk that need special protection.

2 And I think there are a number of

3 susceptibility factors that are looked at both

4 in the animal models and in the human data. 

5 But it strikes me they're a little bit

6 arbitrary at times.

7 And I guess the, and I admit to

8 some personal bias, but I think for example,

9 the genotyping data is very interesting, but

10 whether that really helps you identify

11 susceptible populations in a meaningful way,

12 I'm skeptical about.

13 And I think that there's very

14 little on sex or other susceptibility factors

15 which I think are probably more meaningful in

16 this document.

17 So I think there's a little bit of

18 an imbalance with the overrepresentation of

19 susceptibility factors that are of

20 intellectual interest, but may not have a lot

21 of practical applications, and it

22 underrepresents other factors that may be more

Page 260

1 immediately relevant to a risk assessment

2 process.

3 And then I guess I have a couple,

4 or not a couple, I have a number of very

5 specific comments, which I think I'll just

6 leave for my written comment.

7 DR. FREY: Okay, well, great. 

8 Thank you, Dr. Korrick. Dr. Cory-Slechta?

9 DR. CORY-SLECHTA: So while I agree

10 with a lot of Susan's points, I don't

11 necessarily agree with the fact that you can't

12 have parity between human and animal studies. 

13 And I in fact I think we've made --

14 DR. KORRICK: Like I said, it's

15 just hard.

16 DR. CORY-SLECHTA: Right, we've

17 made a lot of progress I think also in moving

18 beyond IQ in the last five or six years. 

19 First of all, IQ scores don't capture all of

20 what's captured by the word behavior, nor does

21 behavior capture everything that's in an IQ.

22 So if you do a correlation between

Page 261

1 IQ tests and other behavioral measures, you

2 don't see always very good correspondence. So

3 they capture different things.

4 So I think it would have been

5 possible in the integration section actually

6 to capture a lot of what are some of the

7 demonstrated parities now in the animal and

8 the human literature.

9 So for example, I know that in, you

10 know, we published in 2004 from the Rochester

11 Cohort, very explicit data on measures of

12 memory and learning and attention using the

13 CANTAB test in the Rochester Cohort.

14 These are basically the same

15 measures we actually use in animal studies. 

16 So there are very direct correspondences and

17 ways to integrate.

18 Another one I would point out is

19 the work, we've been doing work on stress. 

20 And one of the things we know that lead does

21 is it basically breaks down the negative

22 feedback system for stress.
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1 Well Gump's studies in children has

2 showed exactly the same thing. There is a

3 slower deceleration, if you will, of the

4 cortisol response after a stress exposure in

5 kids.

6 Attention is another one, and I

7 think the Chapter doesn't break this out well

8 enough in terms of the neurobehavioral

9 outcomes.

10 There have been very, attention is

11 another behavioral construct and it means many

12 different things, and people have begun to

13 break down those different kinds of attention

14 deficits, and look at them both in the human

15 and in the animal studies, and there are some

16 very interesting correspondences in things

17 like impulsivity, self control, whatever you

18 want to call it.

19 Another one where I think sort of

20 got short shrift on the human side, and not,

21 maybe got passing reference on the animal

22 side, and is referred to really as auditory

Page 263

1 acuity, is the auditory brainstem evoked

2 response.

3 And this is something that

4 certainly affects auditory acuity, but we also

5 know that when you get changes in some of the

6 peaks of these measures, they relate back to

7 morphological changes and changes in synaptic

8 function and plasticity.

9 So they have very significant

10 implications. These are seen across the

11 animal and human literature, so I think

12 there's some very specific examples that could

13 be put into that section that indeed can

14 integrate it better. And in fact, they show

15 up at very similar blood lead concentrations.

16 One other thing, I thought, just

17 sort of going back to the health thing, the

18 toxicological section at least on the, what's

19 called the neurologic side, but I would agree

20 that is absolutely the wrong term, is kind of

21 disorganized.

22 It separates out Morris water

Page 264

1 mazes, as if somehow those were separate. Now

2 that's just a measure of learning, and it

3 doesn't matter whether I put the animal in a

4 water maze, or an operant chamber, or anything

5 else, it's how I arrange the reinforcement

6 contingencies in the environment, not whether

7 it's in a pool or an operant chamber.

8 And again, here I thought attention

9 could have been broken out, both in the human

10 and the animal literature, and memory

11 separately.

12 So there seems to be some confusion

13 in terms of the tox chapter on, you know,

14 what's what. So there's a section I think

15 called Response Inhibition, which could've

16 been in a section on attention with a much

17 more in-depth assessment of attention deficits

18 as we know them and what comprises them.

19 Just one other thing, there is

20 mentioned, and this comes back to vulnerable

21 populations of stress. And I think we have to

22 be a little careful about that, because one of

Page 265

1 the things we also know from the stress

2 literature is that high levels of stress can

3 be bad, but high levels of stress can also be

4 good.

5 And they can induce what we call

6 resilience, and in fact there is an animal and

7 a human literature on resilience, and I think

8 if you think about it in terms of your own

9 kids, if they don't experience disappointment

10 once in a while in life, they don't tend to do

11 quite as well.

12 And I think we're beginning to

13 understand that as well. So I think we have

14 to be a little careful about how you cite

15 stress. It's not just a unitary kind of

16 phenomenon.

17 DR. FREY: Great, thank you. Yes,

18 that reminds me there was a, I think a story

19 on ABC News before Father's Day about fathers

20 horsing around with their kids, and that that

21 taught them to deal with frustration.

22 And, you know, when a dad grabs a
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1 kid and has them punch themselves in the head,

2 and so I don't know if that's consistent with

3 the, you know, it's like, yes, you must deal

4 with this kind of stress. All right, Dr.

5 Kosnett?

6 DR. KOSNETT: I wanted, let me

7 offer just a few comments on the toxicological

8 integration, the integration on the

9 toxicological data with the epidemiological

10 data. And then I want to just take a moment

11 or two to discuss a concern I had just with

12 the whole approach in Chapter 5 on causal

13 assessment.

14 With respect to the discussion of

15 the toxicological data, I wanted to make a

16 suggestion that you parse out or separate out

17 animal and toxicological studies where the

18 dose is relevant to the low levels of human

19 exposure that we're seeing today.

20 You know, if you consider that if

21 we're concerned about blood leads between one

22 to ten micrograms per deciliter, generally

Page 267

1 speaking plasma lead is about one percent of

2 that, okay? And if you convert that into

3 concentration ranges that would be active at

4 a cellular basis, it's about .5 to five an

5 animal.

6 And why am I concerned with plasma

7 lead? Well plasma lead is, theoretically at

8 least the form of lead that's distributed in

9 the blood stream that's available for uptake

10 into the brain, into the kidney, into the

11 heart, into the vascular endothelium, and the

12 other endpoints.

13 There are, you know, many studies

14 that are discussed in this document that talk

15 about micromolar range, and not nanomolar

16 range, and I think we ought to focus on what

17 can be gleaned from studies that particularly

18 have concentrations that are relevant. The

19 same thing --

20 PARTICIPANT: When you're done,

21 I've got a rebuttal.

22 DR. KOSNETT: Okay. All right,

Page 268

1 that's fine, that's fine. And, you know, some

2 of the doses, you know, of animals exposed in

3 diet to 100 parts per million, which is 100

4 milligrams a liter or 100,000 micrograms per

5 liter.

6 A couple of months ago we were on

7 a panel talking about lead and water, and we

8 were talking about ten micrograms per liter of

9 concern, you know, so some of these levels

10 were extraordinarily high, the animal studies

11 were extraordinarily high.

12 Not to say that they were that

13 value, but let's try to focus on the doses

14 that are relevant to the low level human

15 exposures that are particularly of concern

16 with respect to the ambient air quality

17 standard.

18 The other thing has to do with the

19 temporal pattern. If you look at a lot of the

20 human health effects, like cardiovascular,

21 let's talk about blood pressure which is a key

22 concern.

Page 269

1 Whatever the mechanism that's

2 active in humans to cause them to develop

3 elevated blood pressure, it's not a short-term

4 pharmacological effect. I mean we don't see,

5 for example lead exposed children develop high

6 blood pressure.

7 If you look at the studies, it's

8 not there. And if you look at adult studies

9 to the extent that they exist, you know, and

10 just from basic -- well my personal

11 observations or whatever, is people who begin

12 work in a lead factory don't become, their

13 blood leads might go up in two or three

14 months, their blood pressure doesn't go up.

15 It's not a short-term pharmacologic

16 action. The mechanism of action that is

17 causing some of the cardiovascular effects of

18 lead, and possibly also the renal effects and

19 the neurodegenerative effects, is probably an

20 insidious process or process that has a long

21 latency.

22 And it may be associated with, you
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1 know, oxidative stress on certain organs and

2 how they are remodeled. It may have something

3 to do with epigenetic variability and that

4 could even explain how maybe early life

5 exposures.

6 But whatever, let's try if we can

7 to focus on the toxicological mechanisms from

8 the literature that are consistent with a

9 disease process that would be insidious, in

10 other words, slowly occurring over a number of

11 years or have a long latency.

12 Because in terms of the low level

13 effects of lead that we're dealing with, in

14 humans, that's probably what we're

15 confronting.

16 And then I wanted to just say a few

17 words about the causal assessments that are

18 made in this document. You know, Chapter 1

19 had a nice table on Page 1-25, about the

20 weight of evidence for causal determination.

21 And it sets forth, you know, five different

22 levels. Causal relationship, likely to be a

Page 271

1 causal relationship, suggestive of a causal

2 relationship, inadequate to infer a causal

3 relationship, or not likely to be.

4 And I would make a request or a

5 suggestion that in Chapter 5, that there is a

6 more transparent and rigorous application of

7 how you decided on causal relationships. It

8 was somewhat troubling to me to see on the

9 Table 2-, can someone put up Table 2-26?

10 No, Table 2-3, excuse me, 2-3 on

11 Page 2-26. And the same thing -- my comments

12 would also apply to Table 2-2. But what you

13 notice is that you have, can you, someone's

14 trying to do that? Okay.

15 If you notice on, you know, they're

16 at five micrograms per deciliter. There is a

17 number of different endpoints in adults that

18 are all -- these are all accepted as being

19 causal at that low level of exposure, at least

20 it's implicit in this document. And that if

21 you had someone who was -- exposure occurred

22 under five micrograms per deciliter, they

Page 272

1 would have those effects.

2 And, you know, really there are no

3 human studies, and no animal studies either,

4 that show that if you just confine an animal

5 or a human to a blood pressure under five,

6 that they would develop adverse cardiovascular

7 effects, or develop renal damage, or develop

8 decrements in cognitive function, if you're an

9 adult.

10 Those studies either haven't been

11 done, and I'm not saying that it might not

12 happen, but the data doesn't show that. And

13 I think, you know, particularly with the renal

14 endpoints, there's the whole issue of reverse

15 causation has not been adequately resolved.

16 It's an unresolved issue to the

17 extent to which renal insufficiency causes an

18 elevated serum creatinine, I mean to the

19 extent that an elevated serum creatinine that

20 reflects renal insufficiency causes you to

21 have an elevated blood lead as opposed to an

22 elevated blood lead causing that has not been

Page 273

1 really fully sorted out.

2 And I could go into more details

3 about the renal literature and the studies by

4 you, and Lynn, and colleagues, but we would be

5 here for a long time.

6 DR. GOODRUM: Michael, you're

7 proposing a ranking scheme that kind of

8 mirrors what was in the weight of evidence?

9 DR. KOSNETT: I think -- right --

10 I think that it -- and also what the document

11 does, is it just lumps, it says, there's

12 evidence for a causal relationship of lead

13 with neurological endpoints.

14 If you turn to the previous table,

15 can you turn to Table 2-, yes. Okay, so at

16 five you have ADHD there with children next to

17 decrements in full-scale IQ.

18 I think I agree that there's a

19 considerable amount of evidence that's

20 coherent with the toxicological literature,

21 that has mechanistic explanations of multiple

22 investigators, across multiple studies of
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1 different types about lead affecting IQ in

2 children at low levels.

3 Okay, even down at five. But the

4 data for ADHD is not on the same grounds, on

5 the same footing at this point. It's more

6 preliminary. I mean some of the key studies

7 acknowledge the fact that they haven't been

8 able to control for parental ADHD.

9 And in a disease that is 75 percent

10 or more genetically inherited, that's a very

11 critical thing to control for, parental ADHD.

12 So there's not really a -- this

13 document really doesn't parse out or examine

14 the way I think it could. Where do we, how do

15 we establish causality? And does ADHD really

16 belong on an equal footing with IQ loss, in

17 establishing causation at lead levels less

18 than five.

19 I mean and the causation issue is

20 of course, the issue of does it cause it at

21 any dose, and would it cause it at these low

22 doses. If you go through the entire document

Page 275

1 on all the endpoints, that's of concern.

2 I mean a lot, and I hope that in

3 the next round, that could be given more

4 attention. And in fact, in describing the

5 studies I think it would be helpful if there

6 was an extra column that said basically, the

7 strengths and limitations of all the studies.

8 You know, you have a lot of tables

9 that put forward, you know, summarize the

10 evidence from various studies, but there's not

11 a column in there about limitations of those

12 studies, or relative strength of those

13 studies, or which are the key studies that

14 ultimately get us to this point of saying

15 whether it's causal, or just suggestive.

16 DR. FREY: Okay, great, thanks. 

17 Let's see, we're a little behind schedule. I

18 do want to make sure we have an opportunity

19 for whatever further discussion we need to

20 have on Charge Questions 5.

21 We also need to take our break

22 fairly soon, and we still have three more

Page 276

1 Charge Questions to go. So having said that,

2 is there anyone who wants to say anything more

3 on any of the 5a through e questions? Dr.

4 Pounds?

5 DR. POUNDS: I'll make it quick. 

6 I agree with both Debra and Michael that it's

7 very important to evaluate the experimental

8 design of in vitro experiments to determine

9 their relevance for elucidating to mode of

10 action.

11 But I would want to make sure that

12 EPA, and Michael, and Debra, realize that the

13 simplest and most direct way to do this is

14 just to compare, is to convert the media

15 concentration of the cell culture media to

16 it's blood lead equivalent.

17 But that's absolutely indefensible

18 and inappropriate, even though it's easily

19 done. We know from autopsy studies, animal

20 studies, and dare I say it, biokinetic

21 simulations, that a given blood lead

22 concentration can result in wildly different

Page 277

1 tissue lead concentrations.

2 So the matter of evaluating these

3 in culture -- cell culture experiments is not,

4 how does the culture medium equate to blood

5 lead, but it's how does cell culture, how does

6 the cell lead equate to the lead content of

7 the tissues that's being studied.

8 That studying neurons, then the wet

9 weight of lead in the cell culture should be

10 in the range of tissue lead concentrations

11 from brain. You're not going to find those

12 data very often, but I would argue that those

13 are one, there's others, but that's one of the

14 primary criteria by which you should evaluate

15 in vitro studies.

16 DR. FREY: Okay. Other comments on

17 health effects? Do you have a question?

18 DR. KORRICK: I just wanted to

19 follow-up on one of Gail's comments that,

20 especially for a metric like IQ, it's useful

21 to have information about it's clinical

22 relevance, and that a one point change in IQ
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1 is clearly not going to be clinically relevant

2 for an individual child.

3 And I think that's a good point,

4 but I think there's a complimentary approach

5 in the context of population studies and

6 population risk.

7 And I think the classic example was

8 Herb Needleman's explanation of, you know,

9 like this, so this dent in lead in studies

10 where if you shift population IQs by small

11 amounts, you can impact the tails of the

12 distribution disproportionately and have a

13 larger proportion of kids with either very

14 low, or fewer kids with gifted IQs so that on

15 a population level small changes in a mean

16 indicator for a particular continuous health

17 measure can have an impact, even though on an

18 individual level, there's not a clinical

19 interpretation of it.

20 So, I mean I think that's the

21 classic perspective that we usually take

22 around these kinds of measures. And it's true

Page 279

1 for the blood pressure measurements as much as

2 it is for the IQ.

3 You're talking about a point

4 difference in systolic blood pressure being

5 related to a microgram per deciliter of blood

6 lead, which has no clinical relevance.

7 But on a population basis looking

8 at the distribution of blood pressure on the

9 population, that can shift blood pressures in

10 a way that disproportionately increases the

11 number of people who would meet clinical

12 criteria for hypertension and be at risk for

13 all sorts of cardiovascular disease related to

14 that.

15 DR. WASSERMAN: I'm sorry I have to

16 respond.

17 DR. FREY: Go ahead, sure.

18 DR. WASSERMAN: The shifting of

19 population means in IQ, is to really not based

20 on much of anything.

21 All of the prospective studies

22 which really contribute to the Lanphear meta

Page 280

1 analysis, and really most of the work done

2 even before that, removed kids from

3 investigation who were very low functioning,

4 or who had other high risk conditions, which

5 would've contributed to IQ.

6 So for various reasons, kids with

7 genetic anomalies or other health conditions,

8 so we really don't know, and maybe this is a

9 question for the sort of susceptibility,

10 vulnerability portion of the analysis.

11 We don't really know what the lead

12 effect is on otherwise very low functioning

13 children. So we don't know if a kid has an IQ

14 of 50, and we then expose that child to a high

15 level of lead, whether you will have the same,

16 or greater, or none, or what kind of impact,

17 on his function.

18 DR. KORRICK: Yes, I mean I think,

19 that you're right, and it's conceivable that

20 those susceptibility factor, Deb said, you

21 know, there's a floor effect and, you know,

22 blah, blah, blah.

Page 281

1 But I think just in terms of the

2 mathematics of the distribution of a

3 biological property in the population, you can

4 model shifts in the mean of the population,

5 assuming a particular distribution which will

6 vary depending on the health outcome.

7 And you'll see changes in the

8 proportion of the population, it's a little,

9 it's different than saying what the outcome

10 specific effect of the exposure is, it's

11 looking at the effect of the exposure on a

12 distribution of outcomes.

13 DR. WASSERMAN: But you don't have

14 any data at that point, to say that's what the

15 shape of the distribution would look like to

16 shift that population.

17 DR. FREY: Okay. I think we're

18 heading toward a break unless there's any

19 other Chapter 5 comments. If not, since we're

20 behind, let's just take a ten minute break. 

21 Let's come back at I guess 3:25, and we've got

22 three more questions to go through, so be
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1 ready to go.

2 (Whereupon, the foregoing matter

3 went off the record at 3:14 p.m. and resumed

4 at 3:25 p.m.)

5 DR. FREY: Okay. Well, let's see

6 who is here and who's on the next Charge

7 Question. So we wanted to move toward a

8 discussion on Charge Question 7, which is on

9 ecological effects.

10 I think there was some lingering

11 issues about our health effects discussion

12 just a minute ago about changes in IQ, and

13 partly in the context that the last review by

14 a CASAC and EPA reached a conclusion that a

15 change of, I guess a population change of two

16 IQ points was of public health significance.

17 I'm not sure that what I heard, and

18 I guess the two people involved in that

19 discussion aren't in the room at the moment. 

20 But I don't know that what I heard was

21 inconsistent with that.

22 I think we were talking about half

Page 283

1 an IQ point, as opposed to two IQ points. But

2 that may be something we need to come back to

3 and just clarify whether we're reversing what 

4 CASAC had been saying, which I don't think we

5 mean to do.

6 DR. WEITZMAN: I have a sense that

7 we're going to say the same things.

8 DR. FREY: Okay.

9 DR. WEITZMAN: But, what I took

10 away from what Gail was saying, was a focus on

11 half an IQ point in an individual child, as

12 opposed to a population basis.

13 DR. FREY: Okay.

14 DR. WEITZMAN: And I think that

15 many people avoid then on changes as low as an

16 IQ point on a population basis of having

17 difference in measurable outcomes of function.

18 DR. WASSERMAN: I'm sorry, I missed

19 what you said.

20 DR. FREY: Well what we're talking

21 about is the last review for the lead

22 standard, led to a more or less a

Page 284

1 recommendation that a two percentage point

2 change in IQ was a --

3 DR. WEITZMAN: Two points.

4 DR. FREY: Two IQ points was of --

5 DR. WEITZMAN: Or one.

6 DR. FREY: Or one was of

7 significance, and we had some debate about

8 half a point being perhaps for an individual

9 child not significant clinically.

10 And I think it's an important point

11 as a panel that we clarify the distinction

12 between a clinical outcome for an individual

13 child, versus a population metric of some

14 kind, whether it's an average, or a median,

15 and that, I guess clarify that there is a

16 distinction there.

17 DR. WASSERMAN: I think there's a

18 distinction between statistical significance,

19 clinical significance, and perhaps public

20 health significance, and it would be useful to

21 define what those are.

22 DR. FREY: Well the public health

Page 285

1 aspect is ultimately a judgment. I mean the

2 whole standard setting process ultimately

3 becomes a judgment of the administrator based

4 on input from the staff and from CASAC, and

5 from the public.

6 So it's probably not purely a

7 scientific question, it's an interpretation,

8 and it's also a value judgment in that sense. 

9 Yes?

10 DR. KOSNETT: Forgive me if someone

11 else said this earlier. But, you know, when

12 you identify a small change in any, you know,

13 one to two micrograms, excuse me one to two IQ

14 points, or one millimeter, or two millimeter

15 systolic blood pressure changes, bear in mind,

16 that emerges from the population.

17 There are some people who have a

18 substantially higher impact, and some people

19 probably don't have any impact. I mean that

20 could happen.

21 So, you know, on average though, if

22 you see those even small effects across a
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1 population, that infers that there are some

2 people who are substantially more exposed, and

3 that's a reason to take action.

4 And, you know, the other thing

5 about the ambient air quality standard that's

6 important to bear in mind, is that it's

7 supposed to account for not only vulnerable

8 populations, but to have then a margin of

9 safety.

10 DR. FREY: Right.

11 DR. KOSNETT: Associated with it

12 too, and a lot of times in lead we don't even

13 allow traditionally the margins of safety that

14 are incorporated into regulations for a lot of

15 other substances.

16 So when we bear that in mind, I

17 think there is a public health concern for one

18 to two micrograms per deciliter, excuse me,

19 one or two IQ points, or one millimeter, two

20 millimeter systolic blood pressure.

21 DR. FREY: Okay. Well that may be

22 all that we need to say on that at the moment. 

Page 287

1 I just wanted to clarify that a little bit. 

2 Let's go onto Charge Question 7.

3 PARTICIPANT: Do you want to skip

4 6?

5 (Off microphone comments)

6 DR. FREY: Well we have, yes in the

7 agenda --

8 PARTICIPANT: We got eco first.

9 DR. FREY: In the, well I have on

10 the agenda, Charge Question 7, is not the eco11 effects.

12 PARTICIPANT: Yes it is.

13 DR. FREY: That is the eco-effects. 

14 Okay, so the next set of discussants are Drs.

15 Stubblefield, Herb Allen, Chris Johnson, and

16 Dr. Lanno. And we'll start with Dr.

17 Stubblefield.

18 DR. STUBBLEFIELD: Let me get

19 myself organized here for a second. All

20 right. I will go through the Charge Questions

21 as addressed, and we'll characterize my

22 comments at this point, and then I will leave

Page 288

1 it to each of my compadres here to make their

2 comments.

3 I think that I need to start by

4 saying that I think that Section 7 was an

5 extremely well written, well organized

6 document. It certainly covered an awful lot

7 of information in a very short period of time,

8 and it was quite readable, and excellent in

9 all of those categories.

10 I will say a couple of things. 

11 There's some questions about the desire to

12 stick to 2006 and later data. Clearly that is

13 what was done, that was clearly the charge

14 that was written into the approach that was

15 taken.

16 I think that we need to be mindful

17 that this 2006 number, I gather derives from

18 the previous air review document, and that

19 relied on other criteria, and numbers, and

20 data that proceeded that.

21 But if you look back at the genesis

22 of some of those numbers, like if you're

Page 289

1 relying on what are quality criteria derived

2 values, and those summarizations for the data

3 evaluation, you're really looking at 1985

4 science, you're not looking at anything newer

5 than that.

6 If you're considering the soils

7 effect data, you're really relying on 2003 and

8 older data. And because of that I think that

9 it's very important that we go back and pick

10 up some of the newer information, or at least

11 include that in our summary of the, when

12 addressing the potential effects

13 concentrations.

14 There's also a question about the

15 availability and the use of some additional

16 data that were not included in the document. 

17 And that's deriving predominantly from the

18 fact that most of the data that is, well in

19 fact all of the data that's in there is

20 limited to the peer reviewed literature.

21 And there is a substantial body of

22 information that's been generated over the
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1 last five to six years, that have been driven

2 by the European REACH Regulations.

3 And that has resulted in really

4 pushing forward an awful lot of new

5 information, new empirical data that, if we're

6 going to do the best job we can, we should

7 include that information.

8 Now I know that, it's my

9 understanding that there was a call for data

10 that it went up with the announcement that

11 this work was going to go ahead.

12 And my understanding is that the

13 industry had recommended at that point in time

14 to, or at least acknowledged that they had

15 that data, and that they would make that data

16 available at the time of the REACH

17 registrations.

18 And my understanding is that that

19 has occurred at the end of last year, and so

20 all of that information should be available. 

21 And I know that you can search the European

22 Chemical Agency's website and you can get

Page 291

1 direct access to summarizations of all of the

2 data that has been generated.

3 While we were sitting here earlier

4 today, I actually pulled that document up and

5 went back and looked at the information that

6 was available in there, just as a cursory

7 example.

8 And of the data that were listed in

9 those tables for example, if you're just

10 looking at say invertebrates, aquatic

11 invertebrates for example, there was an

12 additional 26 tests, with at least six

13 additional species, that were all included in

14 the post, as part of the REACH generation

15 process. So there's a substantial database

16 that we really should take into consideration.

17 As far as the organization of the

18 document goes, I felt that it was quite well

19 organized. I liked the separation of the

20 terrestrial and the aquatic effects. I like

21 the segregation on the basis of endpoints.

22 I would suggest that there be, at

Page 292

1 least in the aquatic area, well, I guess, yes,

2 in only the aquatic area, that we would

3 separate marine and freshwater data. There is

4 a clear difference in lead speciation in the

5 marine system versus the freshwater system.

6 The sensitivity of the organisms

7 are reflected as a part of that, and any of us

8 that have ever put lead chloride into water

9 and found out that it didn't immediately go

10 into solution, has learned that lesson. So I

11 would make that recommendation.

12 Moving along in the charge

13 questions here. The second one that we were

14 to address was, is it appropriate to derive a

15 causal determination for bioaccumulation and

16 its effect on ecosystem services.

17 I'm not going to go into a lot of

18 detail on this, because I know Dr. Allen has

19 a substantial series of comments about this. 

20 I'll just say that bioaccumulation,

21 bioconcentration should not necessarily be

22 thought of as an adverse or toxic effect.

Page 293

1 Bioaccumulation as a result of

2 environmental exposures can result in an

3 adverse effect to an organism or to the

4 consumer of that organism, but only if

5 concentrations actually reach a site of action

6 in that organism. And so that has to be taken

7 into consideration, and so I'll leave

8 additional comments on that topic to Dr.

9 Allen.

10 To go on, has the ISA adequately

11 characterized available information between

12 lead exposures and effects on individual

13 organisms. Here I've already highlighted the

14 fact that there's additional data that should

15 be taken into consideration.

16 I believe, I think that the way one

17 should move forward on presenting that kind of

18 data is probably in the form of species

19 sensitivity distributions. It allows us the

20 opportunity to present an array of data and we

21 can highlight in such a presentation new data

22 versus old data.
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1 Frankly if you look at the old

2 data, most of the old data would not be

3 acceptable by today's standards in terms of

4 how we evaluate data.

5 For example, much of the data that

6 was included for example in the original Water

7 Quality criteria, was based on nominal

8 concentrations as opposed to measured

9 concentrations. And by today's scientific

10 standards, those data wouldn't even be

11 accepted. They would be rejected out of hand. 

12 So I think it's important we take that into

13 consideration.

14 Subject areas that should be added

15 and expanded, or removed. This one is an

16 interesting question and I think we need to

17 give some consideration to it.

18 There is a substantial amount of

19 the text that is related to physiological

20 stress, or immunological effects, or

21 neurobehavioral effects in this document.

22 And traditionally the EPA has

Page 295

1 always taken a position when dealing with

2 ecological endpoints, that we look at

3 predominantly effects on populations and

4 communities, as opposed to individuals per se.

5 By taking the, and unless you can

6 make a direct correlation between those

7 measurements and the effects on the

8 population, or the effects on the community,

9 then it's, you're basically changing the

10 paradigm that the Agency has taken with regard

11 to how one considers those data.

12 And it wasn't clear in the text, or

13 the subsequent evaluation of how that is going

14 to be done, or if it's going to be done.

15 If you decide that you are going to

16 continue with the typical EPA evaluation on

17 endpoints, that is to focus on endpoints

18 related to survival, growth, and reproduction,

19 then my suggestion would be to then take the

20 rest of that information and move it into an

21 appendix, or something of that nature, that

22 would allow you to reduce the volume of the

Page 296

1 document. So I'll leave that one there.

2 Questions about soils, I know Roman

3 is going to, Dr. Lanno's going to make some

4 comments on that topic, so I will leave it at

5 that. I will just say that it would be my

6 recommendation that you focus your efforts on

7 natural soils, as opposed to artificial soils.

8 And the issue of how one would go

9 about presenting data associated with

10 environmental parameters. We've made a major

11 point, and I think that it's worth commenting

12 on specifically, is that the question of bio13 availability is really the state of the

14 science today with metals.

15 You've seen this in the development

16 of the Terrestrial Biotic Ligand Models. 

17 You've seen it in the Aquatic Biotic Ligand

18 Models. And so therefore, it is extremely

19 important that that information be taken into

20 consideration in any type of an evaluation.

21 And the way that is probably most

22 easy to present that kind of data in a

Page 297

1 document such as this, is to present the data

2 as adapted for a range of conditions.

3 So for example, if we know for a

4 fact that things like calcium concentration,

5 magnesium concentration, pH, and dissolved

6 organic carbon, all affect the toxicity of the

7 material, then what you do is you present a

8 range of calculations reflecting toxicity over

9 the range of conditions that exist throughout

10 the United States.

11 So cover tenth percentile DOC, 90th

12 percentile DOC, et cetera, et cetera, and

13 present the data in that fashion. Therefore,

14 the reader gets an idea of what the conditions

15 are throughout the U.S., and what the effect

16 of those individual parameters are.

17 So that covers I think the charge

18 questions, or at least my comments on the

19 charge questions. But there's one more issue

20 that I'd like to raise very briefly that

21 wasn't posed as a charge question.

22 And that's the issue of causal
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Page 298

1 determination. There is a section at the end

2 of Section 7 that goes into detail on reaching

3 conclusions with regard to whether a causal

4 relationship has been shown or not.

5 And so when I first looked at that,

6 I started asking myself, what is that really

7 getting at? And I went back to Chapter 1 and

8 read the description of the weight of evidence

9 for causal determination.

10 And the thing that grabbed me was

11 the very first sentence under a causal

12 relationship says in Table 1.2, it say,

13 "Evidence of sufficient," speak Bill,

14 "Evidence is sufficient to conclude that there

15 is a causal relationship with relative

16 pollutant exposures."

17 And that's the part that got me,

18 "with relevant pollutant exposures," because

19 I don't think that that's addressed adequately

20 throughout the document.

21 If you are just looking at lead

22 concentrations and/or whether data exists to

Page 299

1 show that, you know, lead can be causally

2 related to mortality. Well, you know, that

3 can be shown on so many levels, you know,

4 during hunting season, ask the ducks, they're

5 pretty sure there's a causal relationship.

6 But when we start looking at some

7 of these other factors, like effects on

8 growth, effects on, you know,

9 bioconcentration, which I disagree with, I

10 mean but, all of those documents, you've

11 concluded that there is a causal relationship.

12 And I don't disagree that

13 concentrations can cause these effects. I

14 mean it's shown in the literature, but as to

15 whether it meets the standard of relevant

16 environmental exposures is the question that

17 I have.

18 I mean basically what you're doing

19 is you're doing a risk assessment as you move

20 forward with that and you have to adequately

21 address exposures in any risk assessment. And

22 so, well I'll just leave it at that.

Page 300

1 DR. FREY: Thank you. Dr. Herb

2 Allen?

3 DR. ALLEN: I guess I'd like to

4 start off and say, you know, it's in many ways

5 a tremendous document. I looked at this

6 things and said, my god, I have 115 pages to

7 read, yes. And so I started wading through

8 them and found that they were exceedingly well

9 written, that the articles -- and there were

10 lots of articles -- were well summarized, not

11 critically but they were well summarized. 

12 They reflected what the author's said, as

13 opposed to a critical evaluation, I'll talk

14 about that in a second.

15 So I thought all of that was very

16 good. The thing that I said this morning

17 still holds. When I read each one of these

18 sections, I didn't know what the contribution

19 of those two or three or six new papers were

20 to helping you make decisions.

21 Because I didn't know what you

22 thought the state of science was at the

Page 301

1 beginning of the period, and that -- how this

2 modified it.

3 You know, they're great studies,

4 but did they really provide important

5 information. They provided information, but

6 did they provide important information for a

7 rulemaking process? And that really is a key

8 thing.

9 I'm going to hold my comments to

10 two topics. And the first of these is

11 something that's at the bottom of Page 7-9,

12 and that talks about a sequential extraction

13 procedure was employed by Ettler, et. al

14 (2005), to determine the relative bio15 availability of different lead fractions

16 present in soil collected from a mining

17 smelting area in the Czech Republic.

18 I said great, you know, I'm highly

19 biased. I hate to have to tell you this, I

20 think that sequential extraction procedures

21 stink. I don't think they're that good, but

22 it's polite company.
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1 So I have real problems with

2 sequential extraction procedures, but here I

3 read the sentence, and it said, my god, these

4 things really provide useful information. 

5 I've never seen that.

6 So I went into this paper, which

7 incidentally the HERO system, you people are

8 my hero. The HERO system is great. You get

9 kudos for that, click on it, up pops the

10 paper. I can go into the library at the

11 university, I can get that paper.

12 But I can't get most of the book

13 chapters and reports, and those really were

14 helpful. So the system really does provide

15 somebody like me with a great deal of help. 

16 And boy, I don't know that I would've gotten

17 all of the things that I wanted without it.

18 At any rate, back to the sequential

19 extraction procedure. In sequential

20 extractions, what you do is you take the

21 sample, you shake it up with a witch's brew,

22 or, you know, out pops metal, or you analyze

Page 303

1 this, and now you have a number.

2 Well, I took freshman Chemistry and

3 I took a few more chemistry courses after

4 that, and it said if I really want to

5 understand partitioning, I need to have two

6 numbers. One is a capacity and the other one

7 is an intensity.

8 And if I do one extraction, I can

9 only get one number, and there's no way to get

10 two numbers out of one measurement. That was

11 my fifth grade arithmetic teacher told me

12 this, you know, and I paid attention in that

13 class when I wasn't sleeping.

14 So this was my problem in going in,

15 so I really was delighted to find that you

16 actually found this to be useful because you

17 wrote the documents. So I went in and I read

18 the paper.

19 And I got quite surprised. 

20 Determine the relative bio-availability. 

21 Well, I know how to determine relative bio22 availability, we do it in the laboratory all

Page 304

1 the time.

2 You know, something dies, something

3 doesn't grow as well, something goes funny,

4 you know, something happens. So I read this

5 paper and I looked and I looked and I looked,

6 and you know what I didn't find: any organism.

7 Nothing was ever exposed. Tell me

8 how do I determine bio-availability without a

9 bio. This was nothing more than one more of

10 a great litany of papers which have used the

11 same technique, which have said, gee, if it's

12 in the first extractant, you know, it's more

13 bio-available than in the second extractant,

14 and that's more bio-available than the third

15 extractant.

16 Or have I ever seen that proven? 

17 No, not once. Now why do I spend the time

18 doing this? Is it because this is so

19 important? No, it's because as I read the

20 whole document, this is what I see to a large

21 extent in the document.

22 You are citing what the authors

Page 305

1 say, as opposed to having critically looked at

2 the information and assessed the information

3 scientifically, independently, completely

4 independently of what the authors claimed, or

5 the reviewers.

6 Being a journal editor, you know,

7 I can tell you there are excellent reviews,

8 and there are some reviews that I simply mark

9 never ask this reviewer to look at anything of

10 mine again.

11 So these things go on. It is, I

12 think your job, not just to say what is in the

13 literature, but actually to evaluate the

14 literature, and say not, this is a new paper

15 since 2006, but this is a useful paper since

16 2006. That's point one.

17 Point two. Later on and throughout

18 this whole thing, we run into BCF,

19 bioconcentration factors, and then I won't

20 steal what Dr. Lanno was going to tell you, so

21 I'll simply leave it very generic as

22 bioconcentration factors.
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1 I have been very interested in

2 bioconcentration factors. In, oh 1995 or

3 1996, Peter Chapman and I got together at a

4 meeting, you know, we were dealing with, among

5 other things, bioconcentration.

6 And bioconcentration factors are

7 exceedingly useful. They are exceedingly

8 useful in a regulatory framework. They were

9 developed to deal with DDT. Lead is not DDT.

10 DDT and its related compounds have

11 the same property with regard to bio

12 concentration factor. That is, that the

13 concentration in the organism, divided by the

14 concentration in the water, is a constant,

15 roughly.

16 You know, I mean you have to do a

17 little bit of modification to make it true

18 these days, but basically that's what it's all

19 about. Now that's important because if I know

20 the concentration of the organism, I know what

21 the concentration of the water is.

22 If I know what the concentration of

Page 307

1 the water, I can tell you what's present in

2 the organism. They're related by this

3 constant. The BCF, wonderful concept.

4 I'm old enough to remember back in

5 the old Great Lakes data days when we started

6 with DDT in fish, we had no idea what was in

7 the water, because nobody had an analytical

8 method that could measure DDT in the water.

9 But what we did know was that it

10 was directly related, and so we knew that if

11 we had a fish with a higher concentration than

12 another fish, it had been exposed to a higher

13 concentration in the water.

14 And if you did some mapping you

15 could say, gee, there's a contamination area

16 over here relative to here, you know, things

17 like this. So it is actually a very useful

18 thing.

19 Now we come to, you know, use of

20 BCFs in this document dealing with lead, and

21 this is not true. You know, back to the '96

22 story, Peter and I said, you know, we ought to

Page 308

1 put together a little paper that deals with

2 why BCFs are not useful for metals. And we'll

3 put this in as a review paper in Environmental

4 Science and Technology.

5 So Environmental Science and

6 Technology says if you want to write a little

7 review paper for us, send us a paragraph and

8 we'll tell you whether we want it or not.

9 So we wrote them a paragraph and

10 they said, ridiculous, nobody in their right

11 mind would do BCFs for metals. We don't want

12 the paper. 1996, not 2011. Nobody would do

13 this.

14 We wrote back to them, we said,

15 sorry, there's this organization called EPA. 

16 There are these Europeans, they all use BCFs. 

17 They said, what, they're completely nuts. 

18 Write the paper. The paper's in ES&T, it's

19 cited in here.

20 Since then, it does the graph and

21 it does the graph correctly, but with a very

22 limited set of data, and I forget which metal

Page 309

1 we used, but since then, a group got together

2 and they went through all of the literature

3 which was available for metals, and that paper

4 is cited in my review.

5 And what they did was they put

6 together the BCF concentration relationships

7 for metals. Now if metals are like DDT, if

8 you made these graphs, the line would have a

9 slope of zero. They don't. They virtually

10 all have a slope, and the slope is negative.

11 That is the higher the aquatic

12 concentration, the lower the BCF. Now the

13 policy implications of this are tremendous. 

14 If you want to lower BCFs, get rid of these

15 stupid controls that we have on systems and

16 start dumping metals into the environment,

17 we'll lower the BCF.

18 So if you want to make BCFs, you

19 know, the policy, then boy, put more metals

20 out there. That'll lower the numbers. A few

21 organisms might die, you know, but what the

22 heck, the BCFs will be lower on the whole,
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1 right.

2 So this is the problem. It just

3 isn't useful, it's the wrong parameter. Now

4 does EPA know that? Oh yes, EPA knows that. 

5 EPA put together a policy document out of the

6 risk assessment forum called Framework for

7 Metals Risk Assessment.

8 And I suggest, and I suggested out

9 of the last consultation on this, that that

10 document be used. The ARRA Office was

11 involved in putting together, ORD was involved

12 in putting together, everybody was involved in

13 putting together. It went through the Agency.

14 This says BCFs aren't useful. Your

15 document says, gee, here are BCFS, here in

16 wonderful numbers. I don't know what to do

17 with them. With that, I should shut up.

18 DR. FREY: Thank you. Dr. Johnson?

19 DR. JOHNSON: That's a hard act to

20 follow. I'll be brief. One of the Charge

21 Questions was, is it appropriate to derive a

22 causal determination for bioaccumulation as it

Page 311

1 affects ecosystem services.

2 It's already been alluded to, and

3 from what I can gather, Roman's going to talk

4 a little bit more about this too. But of

5 course, it is a tricky question because

6 bioaccumulation, and this is even mentioned in

7 the document, is an ecosystem service, as one

8 of the services that ecosystems provides, the

9 removal of these metals.

10 So you get into this logic where

11 reducing the amount of the metals in the

12 environment actually reduces the value of the

13 ecosystem service, because there's less metal

14 being removed.

15 So my answer to this question, is

16 this Charge Question, is that it probably is

17 not appropriate to, you know, derive this

18 causal determination between bioaccumulation,

19 as it affects ecosystem services.

20 And that kind of goes to the end of

21 the chapter in which, as Bill mentioned, these

22 have these causality determinations. And one

Page 312

1 of them was that there is a causal

2 relationship between lead exposures and

3 bioaccumulation of lead that affects ecosystem

4 services.

5 First of all, having just said that

6 I don't think it makes sense to connect those

7 two. Okay, well if you do connect them, I

8 don't think the case was made in the document

9 that there is a causal relationship between

10 lead exposures and bioaccumulation.

11 And secondly, I wouldn't agree that

12 there's evidence that any such bioaccumulation

13 actually had a substantial impact on ecosystem

14 services, the services that ecosystems

15 provide. So I guess I would disagree with the

16 conclusion that's made in that particular

17 case.

18 The other causal determinations

19 with the caveat of what Bill said about the,

20 what were the environmental levels, that

21 phrase, I was okay with those.

22 Another Charge Question was, are

Page 313

1 there subject areas that should be added,

2 expanded upon, shorten or removed. I agree

3 with Bill that keeping the terrestrial and

4 aquatic systems separate makes a lot of sense.

5 It really helped me read it, to get

6 through it. But the one thing you lose there

7 is you lose, excuse me, you lose any

8 discussion of the connectivity of aquatic and

9 terrestrial systems.

10 And so in freshwater systems in

11 particular, the loadings of metals that come

12 into those systems largely come from the

13 terrestrial environment and there really is

14 not any discussion in Chapter 7 of those sort

15 of watershed-nature linkages of those

16 environments. I think that's a pretty

17 important omission.

18 A relatively small comment to -- a

19 lot of discussion in the chapter talks about

20 aging of lead in soils. It's not really, the,

21 excuse me, the definition of aging is

22 basically leeching following initial influx,
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1 but also binding and complexation.

2 It's a very confusing definition. 

3 I think most people reading it would have a

4 gut feeling of what it means, but it's really

5 not much of a precise definition.

6 Leeching is a physical process. 

7 Complexation and binding are chemical

8 processes. So this idea of aging isn't really

9 aging, it's more physical/chemical

10 transformation of the lead in the soil.

11 The points that are made are fine,

12 but maybe aging isn't quite the right term to

13 use, and maybe it would help readers if

14 another term were developed.

15 And then the last thing I'd say is

16 that I was very disappointed in both these

17 terrestrial and the aquatic ecosystem

18 sections, with the discussions of critical

19 loads.

20 In both cases, what the document

21 said is, well, you know, nobody's really

22 published anything on critical loads in the

Page 315

1 last five years, so I guess it's not

2 important. I guess we don't really need to

3 talk about it.

4 The fact that people haven't

5 published a lot on critical loads doesn't

6 necessarily mean that we are not in a better

7 position to use critical loads analysis to

8 look at some of these question.

9 We have a lot more, well a lot

10 more, there's more data out there. There are

11 more studies that can be used to support a

12 critical loads type analysis. And I thought

13 that the document kind of punted on that, when

14 they probably could've been a little bit more

15 productive. So, I'll stop there.

16 DR. FREY: Okay, thank you. Yes,

17 I think the term aging gets used in other --

18 for other pollutants too. Maybe it's sort of

19 a popular term, but maybe not so precise. Dr.

20 Lanno?

21 DR. LANNO: I would like to concur

22 with the other panel members and say it was a

Page 316

1 well written document, and covered a lot of

2 ground.

3 And I think that the biggest

4 problem I really had with it was linking the

5 context and relevance of exposures that were

6 being made in vitro and lab systems to, but we

7 could use, actually call, you know, policy8 relevant data. And so I'll talk a little bit

9 more about that in a second.

10 But I'll skip right down to the

11 Charge Question, are there any other subject

12 areas that should be expanded upon, shortened

13 or removed. And Bill covered quite nicely all

14 the factors that could affect the bio15 availability of metals in lead and soils.

16 And it's a very complex system. 

17 And there's a really nice schematic in the

18 Metals Risk Assessment Framework that captures

19 the interaction between chemical and metals

20 external to the organism, interacting with

21 environmental matrix, interaction with the

22 membranes, and kind of what happens once they

Page 317

1 get inside the organism.

2 And that might be something that

3 would be useful to incorporate as kind of a

4 summary or introductory diagram or figure when

5 you start talking about bio-availability.

6 I guess this another editorial

7 thing, if you call these editorial. You

8 provided a nice little summary of background

9 levels of aquatic levels of lead, and there's

10 nothing for soils.

11 Now another U.S. EPA document on

12 the Eco-SSL, Ecological Soil Screening Level,

13 guidance for developing Eco-SSLs. If you go

14 to the lead document, they have a nice little

15 diagram of background lead concentrations in

16 the U.S. that might be useful to orient the

17 reader to what's background, what a dose might

18 actually be, a represent -- what a high dose

19 would represent.

20 And along with that the Biotic

21 Ligand Model that we talk about and this is

22 quite complex, and there's some great diagrams
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Page 318

1 that can show, provide a visual for that as

2 well. So, you know, a really good point of

3 talking that you can use to distinguish

4 between various factors that are affecting

5 metal speciation.

6 Along the lines of

7 bioconcentration, I'm following up with what

8 Dr. Allen said here. Throughout the document

9 I find that the terms bioaccumulation and

10 bioconcentration are being used

11 interchangeably. And there are very, very

12 definite definitions, that they are different.

13 And with bioconcentration being

14 solely uptake from water and often an artifact

15 of lab situations, where you test in the lab

16 and it was designed for organic compounds,

17 like Dr. Allen mentioned, so it's got

18 different implications.

19 Bioaccumulation factor would

20 involved anything that is in contact with

21 something that you're not sure where the metal

22 is coming from, so the diet. So it could be

Page 319

1 ingestion of soil or sediment. So sediment

2 and soil tests would involve bioaccumulation

3 factor.

4 And we see the same thing with

5 bioaccumulation factors in soil, they will

6 decrease with the concentration of lead in the

7 soil, metal in the soil.

8 Nominal concentrations, done that. 

9 And I'd like to address the comment, or the

10 Charge Question about, if the ISA was expanded

11 to consider dose response in terrestrial

12 systems, should we limit data to field soils?

13 And I'd say absolutely. Natural

14 soils are the only way to go. We

15 unfortunately, have this substrate that we use

16 for testing organisms called the OECD

17 Artificial Soil, which as any soil scientist

18 will tell you, it's not soil. It may be

19 closer to dirt, Herb, than soil.

20 But it's not a soil. It's a test

21 substrate. And it doesn't really have any

22 relevance if we're supposed to derive any kind

Page 320

1 of guidance with respect to natural soils.

2 It has it's function as a medium

3 that you can use to test proof of principle

4 concepts of exposure to certain elements, and

5 even that's arguable, or certain compounds,

6 some people won't use it at all. But it can

7 be used in that context.

8 And so I don't really think it's

9 appropriate, you know, we have to be careful. 

10 We call soils as well and how we sample them. 

11 There's a lot of guidance out there that

12 involves how to go out and take soil samples

13 in the field.

14 You know, removing the organic

15 thatch and what horizons you're going to use

16 and define those. So there's quite a bit of

17 data available on how to do that in the soil

18 science literature that could be referred to.

19 The other thing is, you know, for,

20 if we're going to develop guidance for plants,

21 hydroponic testing probably is not as useful

22 as full soil, natural soil tests, or

Page 321

1 artificial soil tests.

2 For many organisms, their

3 physiology changes when not in contact with a

4 substrate. That goes for aquatic sediment

5 organisms as well as terrestrial soil

6 invertebrates, as well as plants. You know,

7 plants may not have as much in the way of root

8 hair, so that changes the whole uptake surface

9 that's available for interacting with metals

10 in the medium.

11 So soils are the way to go natural. 

12 Soils that are prepared and sampled, that's a

13 different story, but let's just say artificial

14 soils are not good, and natural soils are the

15 way to go.

16 Throughout the text there's again

17 this idea of relevance and context. 

18 Statements like, accumulated significant

19 amounts of metal, or metal significantly

20 increased, or detected at elevated levels,

21 without the context of where you're comparing

22 it to a control. Is it the background levels? 
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1 What's the comparison being made to?

2 So it's a little bit, I understand

3 that maybe we make the assumption that, you

4 know, if we have a series of concentrations,

5 we're going to, you know, compare our

6 exposures to a zero concentration. But is

7 that zero/zero, or is it a background level of

8 metal?

9 You know, so the context has to be

10 set in a way that we understand what the, you

11 know, the relevance of that effect we see in

12 terms of the increase of the parameter we're

13 measuring.

14 My final comment is basically

15 related to assessing these primary literature

16 documents, and what kind of quality assurance,

17 quality control, are we going to use to assess

18 whether or not the document and the data

19 within the document are actually useful for

20 developing any kind of assessment with respect

21 to lead in soils.

22 So there is an example for instance

Page 323

1 of an I think it was a nematode experiments,

2 when they have I think it was exposed in agar,

3 and they had some molar value of lead

4 exposure, and looking at defects in

5 development and behavioral aspects of the

6 nematode.

7 And I'm thinking, okay, so how do

8 we relate that to population level effects. 

9 It's possible, but it's an in vitro test from

10 a plate where you're exposing them in

11 solution, with no soil, and so how do we get

12 to the nematodes that actually live in the

13 soil. Same species, but, you know, different

14 test media.

15 And so we have to remember that, in

16 working with organisms as Bill said, we're

17 interested in community and population

18 effects, but not just structure, the function

19 as well.

20 And that's something that, you

21 know, we have organisms that people don't care

22 about. You know, who cares if worms get

Page 324

1 cancer, maybe the fisherman do if they can't,

2 well even if they got cancer, you can take

3 them fishing I guess.

4 But, you know, the bottom line is

5 that they're performing a function out there. 

6 They're turning over soil. They're ingesting

7 soil and organic carbon, and well then carbon

8 cycling as our collembola, as are bacteria.

9 And within that whole community,

10 there's this term called dysfunctional

11 redundancy, were often interested in just, is

12 the carbon cycled, and we don't care what

13 cycles it. So we have to remember that

14 context as well. It's, you know, not just the

15 organism.

16 So for bacterial tests in soil, we

17 will be looking at, you know, nitrification

18 processes and such that are important in

19 supporting all the ecosystem services that we

20 have.

21 So I think, you know, from that

22 context, let's try to make sure we use the

Page 325

1 right studies to describe what it is that we

2 want to do within policy development, make

3 them policy-relevant.

4 So there are a number of questions,

5 and it was a great guidance and again,

6 presented in the Eco-SSL document, as to what

7 are good studies to use from the primary

8 literature if we're doing this. So if you can

9 refer that document, that would be a good

10 place to start.

11 DR. FREY: All right, thank you. 

12 Other comments on Chapter 7 and the Charge

13 Question for Chapter 7? Yes, Dr. Kosnett?

14 DR. KOSNETT: I had a question and

15 then a comment. And maybe, Roman, you can

16 answer this question about aging of lead in

17 soils. I mean I saw that there was a

18 discussion in there that aging tended to

19 increase lead's interaction with organic

20 material in the soil, and render it more

21 immobile.

22 And I just had a question about
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1 aging of other mineral deposits of lead. Like

2 is it the case though, that when you have mine

3 tailings, like lead sulphide, and it gets

4 weathered, it becomes a sulphate or perhaps

5 even a carbonate, and becomes more mobile. Is

6 that correct?

7 DR. ALLEN: That's correct.

8 DR. KOSNETT: And should that be

9 reflected in here somewhere, I don't know. I

10 mean that might apply just to tailings, but I

11 didn't, when I read that I was just a little

12 confused because I had heard that.

13 DR. ALLEN: It applies not just to

14 tailings, but also to rice paddies. It

15 applies to reservoirs. Sulphide oxidation is

16 a well known phenomenon.

17 DR. KOSNETT: And that's considered

18 aging? That --

19 DR. ALLEN: That is, that certainly

20 is one aging and it does not make things less

21 mobile, but makes them more mobile. So, what

22 is observed in adding metals to soil are

Page 327

1 generally from spiking experiments is that,

2 without leeching, even without leeching, so

3 that we don't have a mass-balance problem.

4 That with time, the assessibility

5 as a very general term, becomes less. And

6 this is due to physical/chemical changes,

7 reactions that are slow on the time scale of

8 these kind of observations, which are days to

9 months to years.

10 DR. KOSNETT: Okay so if I, perhaps

11 if I, and just to simplify it, is it possible

12 to say then, that when lead's already soluble,

13 in a soluble form, and it sits and ages in the

14 soil, it binds to organic materials and

15 becomes more immobile.

16 But if you start with a lead

17 sulphide, and you, like in tailings, and it

18 gets weathered, then there might be a period

19 of increased mobility?

20 DR. ALLEN: Yes.

21 DR. KOSNETT: Is that a way to put

22 it all together?

Page 328

1 DR. ALLEN: That's exactly what

2 will happen. Like we've done some recent

3 experiments in the laboratory not with lead

4 sulphide, but with another tailing, and that's

5 exactly what happens in the system.

6 DR. KOSNETT: And then I had one

7 other comment. And this was actually a

8 comment similar to one that I made earlier

9 this spring about the issue of commenting and

10 mentioning the extraordinary lead burden of

11 raptors that occurs in various parts of the

12 United States.

13 Now, you know, that is a

14 consequence of the use of lead ammunition. 

15 And in the initial planning document it said

16 that the document won't consider the extent to

17 which ammunition contributes to the food

18 chain, and lead body burden of wildlife,

19 because that's not a source relative to

20 consideration of air-related lead.

21 But we do note that the document in

22 many other places considers background lead. 

Page 329

1 And especially in the human section, you know,

2 we have a document on air lead, but we're

3 talking about contribution of paint and other

4 sources as it contributes to background.

5 And I think it would be, I would

6 like to make a request again, and I don't know

7 if there's a consensus or support for this,

8 but I hope there might be, that in order to

9 fully assess the impact of cumulative lead

10 from all sources including airway, pathways,

11 or air-related pathways, it's worth noting in

12 as comprehensive a document as this ISA is, of

13 that fact that, of all the wildlife out there,

14 probably the most highly impacted by lead are

15 the predatory birds, or the raptors.

16 You know, there was a study in 2009

17 in the Yellowstone ecosystem of 63 bald eagles

18 and golden eagles. And the median blood lead

19 concentration in those eagles were 41

20 micrograms per deciliter. And they're our

21 national bird, as an aside.

22 But, you know, so I just think that
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1 I would like to make a request and if people

2 agree, there's a consensus that at least there

3 be mention in here of that impact, of that

4 extraordinary background, because I don't

5 think there's any other animal, group of

6 animals that have that much lead. Does anyone

7 disagree with that?

8 DR. CORY-SLECHTA: So avians have

9 a nucleated red blood cell, so they bind lead

10 differently. They have higher blood leads

11 because of that. So I'm not sure you can

12 compare them directly to mammalian red blood

13 cell binding.

14 DR. KOSNETT: Do they have that? I

15 mean other birds don't have that --

16 DR. CORY-SLECHTA: No, mammalians

17 don't.

18 DR. KOSNETT: -- it's the eagles,

19 the predatory birds.

20 DR. CORY-SLECHTA: But still I'm

21 not sure what that means relative to what we

22 think of in terms of mammalian blood lead

Page 331

1 concentrations. I don't know how those curves

2 intersect, or where they intersect.

3 DR. KOSNETT: And that's a good,

4 that's an interesting point and I respect

5 that. But I'm just saying that this document

6 doesn't mention the extraordinary occurrence

7 of high lead levels in predatory birds as a

8 consequence of, probably of ammunition to a

9 certain extent. And I just want it to be

10 mentioned. I would like to request it be

11 mentioned.

12 DR. FREY: Well it seems like, yes,

13 reasonable enough to mention it, and mention

14 the different, I guess the different way lead

15 binds in avians. And I'm not sure if the

16 health implications are that well known, or

17 the species survival, or growth effects.

18 DR. KOSNETT: When, you know, and

19 I don't want to belabor this point, but when

20 it does come to things like the California

21 Condor and eagles and all that, there have

22 been a lot of adverse health effects

Page 332

1 documented at the high levels that are being

2 seen.

3 DR. FREY: But I think if that's in

4 the context of exposure to lead ammunition, it

5 seems like something that could be noted, but,

6 unless it's important to a background

7 characterization because there might be a non8 linearity in a response function, then how far

9 the EPA needs to go with that is I think maybe

10 not very far.

11 DR. KOSNETT: Yes, I don't think to

12 the extent that it contributes to background

13 and there's a desire to capture parts of

14 terrestrial organisms that have particularly

15 high backgrounds, I think is, it might be

16 worth mentioning.

17 DR. FREY: Okay. Okay, sounds fair

18 enough. I think we need to move on unless

19 there's a burning issue on ecological effects. 

20 We'll go to Charge Question 6, which is on

21 susceptible populations and life-stages.

22 We're at about 4:20. I do want to

Page 333

1 try to adjourn by 5:30. And we have this

2 Charge Question and then Charge Question 2,

3 which is on the integrative summary. 

4 So in making your comments, if you

5 might just keep in mind, you know, your

6 written comments will be part of what goes to

7 EPA. I think the focus here would be on, you

8 know, the significant comments that we all

9 need to hear, and EPA needs to hear.

10 But anything that's sort of

11 detailed maybe you can reserve that just for

12 your written comments. Yes, Dr. Hopke?

13 DR. HOPKE: And the lead discussant

14 should be pulling together all of the comments

15 from all of the people to make an integrated

16 consensus report.

17 DR. FREY: Sure, that's right. 

18 Yes, and that's a good reminder. I mentioned

19 this at the beginning that the lead

20 discussants should be identifying the key

21 points that would go in the Summary Consensus

22 Response to the Charge Questions.
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1 I would like the lead discussants

2 to draft something by this evening so that

3 this could get emailed to me, so that I can

4 bring something back tomorrow.

5 We might not spend a lot of time

6 talking about it, but I'd want at least a

7 preliminary idea of where we are in answering

8 the Charge Questions.

9 And I've been taking a lot of

10 notes, so I have some idea, I think of what

11 our answers are, but I really want to get the

12 input from the lead discussants. So just keep

13 that in mind. That applies to about a dozen

14 of you who have a little bit of homework for

15 tonight.

16 Okay, let's go ahead and get into

17 Charge Question 6. This is Doctors Weitzman,

18 Cory-Slechta and Wasserman. And let's start

19 with Dr. Weitzman.

20 DR. WEITZMAN: I thought that this

21 was an important, kind of well-crafted

22 chapter. I did have a number of concrete

Page 335

1 issues with it, and then suggestions.

2 Beginning with the title. So it

3 does deal with susceptibility and it does deal

4 with age as one of the characteristics that

5 lead tracks with, but there are a whole host

6 of other things that are discussed in this

7 chapter as well, such as where do you live,

8 nutritional status, and so it really is not

9 exactly capturing what the chapter's about. 

10 So the chapter's division deals with

11 susceptibility to exposure and absorption of

12 lead as one part of it. And the other is

13 susceptibility to adverse consequences given

14 a certain exposure.

15 And I like that a great deal, but

16 I think that it was difficult for the people

17 who wrote this to stick to it. And so I kept

18 on getting confused because, in different

19 sections, the authors actually had things

20 mixed up.

21 So for example, underneath the

22 effects in nutrition, there's some discussion

Page 336

1 of nutritional consequences of different lead

2 levels. But there's virtually nothing

3 discussed about nutrition as it leads to

4 absorption of lead, or to behaviors that

5 might, like pica that might increase it.

6 But I won't waste a lot of time on

7 this because I actually have, and what I've

8 written, specific pages of numbers where

9 things appear.

10 A generic issue was raised for me

11 in this chapter in that, repeatedly in the

12 chapter, there was mention, and in other parts

13 of the report, this was discussed in more

14 detail.

15 And I think it would make it a lot

16 easier if either the page references, or

17 hyperlinks were provided to those areas where

18 that was discussed.

19 And this is a variation on

20 something that several people have brought up,

21 including the gentleman who spoke this morning

22 representing the public, was now the member of

Page 337

1 the board, which is that, in the Effects

2 section, there are a fair number of variables

3 that are mentioned that are supported by one

4 or at most two studies. And for example, the

5 study on ADHD being heightened amongst

6 children who have secondhand smoke exposure,

7 and leads as well.

8 That's one study from NHANES. It's

9 cross-sectional. So that really we need to be

10 very careful in any way suggesting that there

11 are causal inferences here.

12 This is something, in fact this

13 chapter more than any other part of this

14 report for me, I found myself wanting to write

15 laundry lists of unanswered questions about

16 susceptibility. So that's what kept on coming

17 up for me.

18 There are a number of medical

19 mistakes in what's written. So for example,

20 in speaking about weight and blood lead and

21 renal function, so a BMRI of 25, and I'll give

22 you more examples, is not being obese, that's
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1 overweight.

2 So there are a number referring to

3 people with diabetes as diabetics is now in

4 the medical community seen as something that's

5 impolite. You don't define somebody in terms

6 of a characteristic that they have. People

7 are more than the sum of their disease, and

8 that appears in a number of places here.

9 As relates to susceptibility to

10 lead exposure, I thought that there were a

11 number of things that, and it may be my bias

12 given what I count, my professional

13 background, but housing is extremely important

14 to children or to individuals' blood leads.

15 And it may or may not directly

16 affect them via exposures inside the house. 

17 So many of the things that we're discussing in

18 terms of ambient lead may be a consequence of

19 deteriorating exterior paint.

20 And HUD and the National Center for

21 Healthy Housing, has mapped using geographic

22 information systems, extremely well those

Page 339

1 parts of the country that have older houses or

2 don't have replaced windows.

3 And I think that if the point of

4 this is to be encyclopedic about the knowledge

5 that we currently have about exposure and

6 consequences, to me it doesn't make sense to

7 ignore housing, or urban/rural residence, or

8 proximity to -- it came up today, somewhat

9 jocularly about proximity to an airport, so

10 there are many sources that we know that there

11 are ways in which you could highlight children

12 as being exposed.

13 Again, I'm slipping over into what

14 isn't known, when you said, Michael, that 75

15 percent of ADHD is associated with genetics. 

16 It's 75 percent of it runs in families. All

17 right, so you have parents who have it.

18 So it may be that having a parent

19 who has ADHD enhances the likelihood that,

20 given a specific exposure to lead, that you're

21 going to develop it as well. So yes, there's

22 a genetic basis to ADHD. There's a genetic

Page 340

1 basis to absorption of lead. And I didn't

2 think that that kind of thing was discussed

3 well enough.

4 I mentioned the nutrition. There

5 was an extensive literature, at least on iron,

6 there's a much more rudimentary literature on

7 calcium and fat intake and children's

8 absorption of lead although, if you look at

9 the pediatric literature, people speak as if

10 it's a given, the calcium metabolism.

11 And calcium metabolism again, I

12 don't know that it belongs in this document. 

13 But Vitamin D receptor genes have been shown

14 to be associated with lividity of absorption

15 of lead.

16 Part of the obesity epidemic is

17 that at least serologically, that very

18 substantial parts of the population now are

19 measurably Vitamin D-deficient. Although,

20 that raises all sorts of biologic questions.

21 If Vitamin D, which is a fat

22 soluble vitamin, is in cells, does that mean

Page 341

1 that it's unavailable to function in terms of

2 its other functions? That is a whole emerging

3 literature.

4 But I don't know how exactly how

5 they're related to this, other than that we

6 know that lead is intimately tied to bone

7 metabolism, as is calcium and Vitamin D.

8 So I have a number of other things,

9 but I think I'll save that for the summary

10 that I'll put together.

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

12 Dr. Cory-Slechta?

13 DR. CORY-SLECHTA: Well, I had some

14 very specific things, to some extent I take

15 exception to, or maybe think we ought to

16 consider a little more critically, that show

17 up in the susceptible populations.

18 There is significant discussion in

19 there, as well as other parts of the document

20 amount gene/environment interactions. And

21 there's never in any place in the document any

22 indication of the magnitude of those effects.
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1 So this has come up peripherally

2 before, but, you know, are we talking about a

3 one percent or a two percent change, how

4 important are these as susceptibility factors? 

5 Are they really, even, you know, a

6 beta coefficient doesn't really tell me

7 anything. If I'm talking about, are they

8 really changes of biological meaning in terms

9 of susceptibility, I can't tell from the

10 document. And a lot of what I see in the

11 literature doesn't suggest to me that they are

12 necessarily all that critical.

13 I think another thing that tends to

14 give over-sold has become dogma in the

15 literature more than anything else is that

16 early development is the most vulnerable

17 period.

18 And there clearly are, if we think

19 about things like toxicokinetics, that there

20 is greater vulnerability early on, but I would

21 suggest there is a significant database to

22 show that later periods in life generate lots

Page 343

1 of adverse health effects.

2 You know, there's a huge rodent

3 literature showing exposures that don't even

4 start until, you know, adolescence or later,

5 can have great effects. The greatest effects

6 on LTP, which is the underlying physiological

7 substrate for learning, occur post-weaning in

8 rodent models.

9 So I think we tend to oversell it. 

10 We state it. We don't put references in. And

11 I would note in the document, it's stated

12 several times with no references whatsoever.

13 So I think we tend to give it

14 greater emphasis than it deserves. Even some

15 of the longitudinal cross-sectional studies

16 where effects later in life were being

17 attributed to blood leads at two years, are

18 being reinterpreted because current blood lead

19 at seven, eight, nine, ten, 15 years old, is

20 as good or not better predictors.

21 So I think that needs more careful

22 thought than to just throw those old phrases

Page 344

1 back out there.

2 And I want to come back to this,

3 two other issues. One is the importance of

4 gender. It just strikes me as just

5 extraordinary that, with all the literature on

6 lead, it's probably been studied more than any

7 other environmental chemical, we know almost

8 nothing about gender.

9 If the animal studies tell us

10 anything, we almost never see the same effects

11 in males and females. We never put them

12 together. They're always divergent. 

13 So let me give you a little

14 example. We know that blood leads always tend

15 to be slightly higher in males than females. 

16 We don't really know why.

17 So if you're thinking about the

18 distribution and the non-linearity of the

19 dose/effect curve, where presumably there

20 would be a greater number of girls because

21 the blood leads are lower, maybe in fact girls

22 are more sensitive.

Page 345

1 So the need to stop statistically

2 controlling out the effects of gender and to

3 look at those modifiers, and I think gender's

4 gotten far too little attention.

5 One thing that does come up in the

6 document, and I think is going to be important

7 in the future is the potential for epigenetic

8 changes and I think what they suggest in terms

9 of susceptibility, is the role of the maternal

10 and the paternal contribution to what those

11 might be later in life.

12 And I would also agree with the

13 comments about nutrition. And I think if

14 we're going to talk at all therapeutically,

15 most of those early studies were not done in

16 a way in populations where you could actually

17 determine how useful iron supplementation or

18 calcium supplementation were.

19 But again, I think that's something

20 that deserves a little bit more attention. So

21 those are my comments. Thanks.

22 DR. FREY: Great. Thank you very
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1 much. Next is Dr. Wasserman.

2 DR. WASSERMAN: I would agree with

3 those comments. This chapter's a real hodge4 podge of effects. And effect modifiers that

5 appear in a single study to me, should be very

6 suspect until -- I mean on the one hand we

7 have studies of IQ and lead, and there's like

8 hundreds and thousands of papers and then we

9 have like one study that finds something.

10 And there has to be some way of

11 saying there are 45 of these, but only two of

12 these, and they shouldn't all be presented

13 with a similar level of, gee, this is new and

14 interesting.

15 In fact the table that's in this

16 chapter, the Table 6-3 that lists all the

17 possible modifying factors, for almost all of

18 them the authors rightly conclude that more

19 evidence is warranted.

20 So I think that's the general

21 conclusion. But maybe it could be shrunken

22 down or integrated somehow better.

Page 347

1 DR. FREY: So maybe a general

2 warning, unless otherwise noted, more evidence

3 is needed or something like that.

4 DR. WASSERMAN: Exactly.

5 DR. FREY: Okay.

6 DR. WASSERMAN: Here's a list of

7 things for which we, that might be

8 interesting, but, gee, we'd like more.

9 DR. FREY: Right, okay. Was that

10 it? Those are your comments?

11 DR. WASSERMAN: Yes.

12 DR. FREY: Okay. I'm sorry someone

13 raised their hand. Yes, go ahead?

14 DR. WEITZMAN: Okay, but only in a

15 more general way on this topic.

16 DR. FREY: Okay. Well, I think all

17 the lead discussants have spoken.

18 DR. WEITZMAN: May I just?

19 DR. FREY: Yes, go ahead, and then.

20 DR. WEITZMAN: It relates to what

21 Debbie said.

22 DR. FREY: Okay, sure.

Page 348

1 DR. WEITZMAN: I won't belabor it. 

2 You know, there's a much more extensive human

3 epidemiologic literature on IQ than many other

4 subtle but serious, you know, cognitive

5 decrements.

6 And what Debbie was pointing out

7 about, what we call critical windows of time,

8 and people will frequently talk about lead not

9 having a single biologic signature. It may

10 very well in part be due to different timing

11 of exposure. So you may have different

12 effects. And you may be susceptible to

13 different types of effects at different times.

14 DR. WASSSERMAN: Especially since

15 so many neurodevelopmental functions can't be

16 measured reliably, you can't even find

17 differences until adolescence. So if we're

18 not looking and because this document would

19 suggest, why even bother looking at

20 adolescence.

21 And other parts of these other

22 documents would suggest that the older people

Page 349

1 get, the harder it is to even quantify what

2 their exposure is. But again would say, let's

3 not even go look there. But there's many

4 things that you can't even identify until you

5 look there.

6 DR. FREY: Okay. Yes, go ahead.

7 DR. RABINOWITZ: Well, if I could

8 just, I suppose, share a bias I have with you

9 all. And that is, I know a lot, year by year

10 more and more work is being done on

11 susceptibility in subpopulations, and it's

12 very important to find out who's the most

13 vulnerable to protect them.

14 Mostly we learn a lot about

15 mechanisms. However, the biggest predictor of 

16 lead's effect on a person are not these

17 details about the person, but how much lead

18 there is.

19 And I'm afraid that we only have so

20 much emphasis to go around, only almost

21 resources to go around. And I don't want to

22 lose sight of the major factor that is
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1 affecting people's ill effects from lead is

2 how much lead is there, rather than some other

3 factor that modifies the effect.

4 DR. FREY: Sure, yes.

5 DR. CORY-SLECHTA: I think well,

6 no, I just think there's a different

7 interpretation of effect modifications, so,

8 and I'm very acutely aware of this is that,

9 lead may have effects at far lower levels in

10 the presence of some modifier, than it does

11 without that same context. And therefore, you

12 know, it can change essentially what we're

13 talking about as effective levels, and that's

14 not just for lead, it's for an toxicant.

15 So it may be that lead has effects

16 at one microgram instead of ten micrograms if

17 it's in the presence of insufficient iron

18 status or something like that. So I think

19 it's not just where the money goes, but, you

20 know, when we're talking about, more about the

21 risk assessment, per se.

22 DR. FREY: Phil, did you want to

Page 351

1 add something?

2 DR. GOODRUM: Yes, I'm just hoping

3 Michael can help me out here a little bit,

4 because I think I understand what you're

5 saying is that, you know, it's the mass. It's

6 the dose.

7 But I think in terms of setting

8 standards, you know, all things being equal,

9 and in other words, all populations being

10 exposed equally, is there an unequal response

11 due to differences in susceptibility. So I'm

12 just struggling a little bit with your point

13 on it's the quantity that is really the

14 driver.

15 DR. RABINOWITZ: Well, maybe I

16 didn't express it well or maybe I'm wrong. 

17 But I think that the, one of the major drivers

18 of lead toxicity is how much lead's in the

19 environment.

20 Now I know our task is to protect

21 the most vulnerable among us, and for that

22 it's good that we go through all these other

Page 352

1 exercises.

2 But I just wanted to have a naive

3 reader take away from this big fat document,

4 that what's important is how much lead is in

5 the environment, as well as these other

6 factors.

7 DR. GOODRUM: But it's the standard

8 setting that kind of influences how much lead

9 gets in the environment, so where we set that

10 standard, it's like a bad calculation, you

11 know.

12 DR. RABINOWITZ: To protect the

13 most vulnerable.

14 DR. FREY: Okay, any other burning

15 issues on Charge Question 6? Going once,

16 going twice, okay. Let's go to Charge

17 Question 2.

18 So this is the integrative health

19 and ecological effects overview. And now that

20 we've covered everything, we can, I guess,

21 focus on the integration aspects of Chapter 2.

22 And we have, let's see, one, two,

Page 353

1 three, four, five, six, seven, eight

2 discussants on this. So just keep in mind

3 that we probably have about 40 minutes on

4 this, at most. So 40 divided by eight is

5 five, right. So five minutes or less per

6 person. The lead discussants will start with

7 Dr. Davidson.

8 DR. DAVIDSON: Okay, thanks. 

9 Thanks very much, Chris. Basically I felt

10 that Chapter 2 was probably the most difficult

11 chapter to write. And I also think that it

12 may end up being the most problematic.

13 Although, I think that there is a

14 lot of positive to say, is that it's a

15 tremendous synthesis of information, and that

16 synthesis that has parts that are well

17 presented.

18 The main overall problem that I

19 have with Chapter 2 is that it is, I guess,

20 not consistent in terms of both the content

21 that it has, and also inconsistent in terms of

22 how it references the other chapters.
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1 The content is a problem because

2 it's pretty clear that there are value

3 judgments being made here about, what is

4 important enough to include in Chapter 2, and

5 what is not sufficiently important, so you

6 just basically leave it in the rest of the

7 chapters without bringing it to bear in

8 Chapter 2.

9 And that's a very difficult thing

10 to do, and I'm not sure that everybody would

11 agree with the judgments that were made on

12 what to include in Chapter 2, versus what to

13 leave out.

14 When I read through Chapter 2,

15 there are certain areas where that I feel are

16 well written, but I want to get more

17 information on it. And so therefore, I would

18 like to know where it is in the rest of the

19 document that I can go in order to get that

20 more information, the more detailed

21 information.

22 Some sections like, a notable one

Page 355

1 is, let me see here, Section 2.8.4.1, on

2 Exposure of Children, has lots of detail with

3 regard to where it is later in the document

4 that I can go and look this up.

5 Now there's a trade off here

6 between having so many citations to the later

7 chapters, that it almost ends up being

8 difficult to read.

9 On the other hand, the good thing

10 about it is that any detail that I want in

11 that Section 2.8.4.1, I know exactly where to

12 go to get more information. So there's a

13 little bit of a trade-off here between making

14 it easy to read and making it easy reference.

15 Conversely to this particular

16 section, there are several other sections

17 where the reader does not know where to go in

18 the rest of the document to find the

19 information.

20 And then there are some sections

21 where the content is not very thorough, and in

22 addition, there are not a whole lot of

Page 356

1 citations to the other chapters. So, you

2 know, kind of the bottom line here is

3 consistency all the way through. That's all

4 I have.

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

6 Dr. Wasserman?

7 DR. WASSERMAN: I think as I

8 understood what was, that this is a summary,

9 but I also remember reading in Chapter 1, that

10 the first task is to determine causation and

11 then only if there's causation determined,

12 then to look at the magnitude of causation.

13 Because there's very little

14 reference in this Chapter 2, again to effect

15 sizes. But I'm not sure whether that's, that

16 may be because of this framework of, here

17 we're going to talk about causality, and then

18 later we'll talk about the magnitude.

19 On the other hand, so that would be

20 a plus for having this organizational

21 framework. This is just causation, amount of

22 causation.

Page 357

1 My concern would be that most

2 practitioners are going to read Chapter 2, and

3 no much else in this document. So I think it

4 really behooves us to have this to be as solid

5 as possible.

6 So it might be useful then to weave

7 in some aspect of clinical significance to

8 these effects that are mentioned here. Aside

9 from that, my points about Chapter 5 in terms

10 of the nomenclature, and some of the other

11 ways of considering things, so it all applied

12 to discussion here.

13 I like very much the framework of

14 saying, you know, this is a strong effect,

15 this is a minuscule effect, that's really very

16 helpful. That's a very nice rubric to carry

17 forward.

18 My concerns have to do primarily

19 with the fact that many people are just going

20 to stop here. And so is that, do you have in

21 here what you want to have in here.

22 DR. FREY: Okay, thank you. Next
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1 is Dr. Herb Allen.

2 DR. ALLEN: I echo what Dr.

3 Davidson said on having a link in some way to

4 the more detailed information in other

5 chapters.

6 It certainly would help. It should

7 not be the reader's responsibility to try and

8 find where the information is that supports

9 the one or two sentences. And I think there

10 are a number of ways that can get handled.

11 A couple of, I have a number of

12 comments, but I'll give you only a couple. 

13 The correlation of lead with zinc, bromine,

14 copper, and potassium from around the airports

15 was absolutely fascinating.

16 But, you know, shouldn't that be

17 followed up. If airplane fuel makes up 49

18 percent of the lead, then there have to be

19 very, very strong correlations of potassium in

20 that fuel, compared to potassium from other

21 sources.

22 And my guess is, that isn't true. 

Page 359

1 My guess is that some of these correlations

2 are completely spurious. And again, that was

3 my point of, I think that you need to take a

4 deeper look at the information, other than

5 simply reporting what is said.

6 And I haven't gone through that

7 analysis myself, but that's simply a guess. 

8 I think the copper, and others come from other

9 places. Bromine probably does come from the

10 fuel in the absence of significant signatures

11 from sea spray, which will overshadow it.

12 You use an LC50 as a measure to

13 compare environmental concentrations. I would

14 suggest that an LC50 probably, I'll defer to

15 my biologist friends, but killing half the

16 population is probably not a good idea.

17 You know, even as a chemist, I see

18 that. So if you're going to use a comparison

19 to an effects concentration, I'd pick an LC5

20 or an LC10, as being the kind of a number that

21 you might get away with, without raising

22 everybody's hackles, you know, in the process.

Page 360

1 One more on where I think you need

2 to be careful on taking data from the

3 literature. And that is, if I can find my own

4 comments. You have on Page 40, a discussion

5 of sediments, let me read you the one sentence

6 here, sediments are one of the things I happen

7 to have done some work on in my life.

8 "Since the 2006 lead AQCD, there is

9 further evidence for the effects of lead in

10 sediment associated communities, exposure to

11 three levels of sediment lead contamination,"

12 and it gives the levels, "eye on a microcosmic

13 experiment, significantly reduced nematode

14 diversity and resulted in performing of

15 restructuring."

16 It had effects. So I looked at the

17 study, the first thing they did was to silt

18 the sediments and oxidize them. These aren't

19 sediments anymore, they're laboratory

20 manipulated former environmental sediments.

21 And how to relate this to what's

22 going on in the environment, I don't know. 

Page 361

1 There isn't any sulphide left. You got rid of

2 it all. So it's modified and these effects

3 are not what you would see in the environment

4 and certainly not at these concentrations.

5 So I, you know, again I think you

6 need to really delve into what the studies

7 actually did, and then whether these data can

8 actually be used to draw these kind of

9 conclusions.

10 Or whether there might be

11 artifacts, and there's nothing wrong with the

12 study. I mean, you know, they did this, they

13 found this, those are the effects they found. 

14 It's now taking this and trying to extrapolate

15 it and use this as saying, ah, ah ah, look at

16 this, you know, that's the problem. With

17 that, I be quiet.

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

19 Korrick?

20 DR. KORRICK: So I don't have a lot

21 to add, just two comments. I think that

22 because this is the section that maybe people
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1 will start with, as integrating, that it's

2 important to set a tone of sort of, clear

3 thinking in this section.

4 And there are a number of examples

5 which I'll send in with my written comments

6 that that doesn't appear to be the case, I'll

7 give one that I found particularly confusing

8 on Page 11.

9 Which says, studies of adults

10 without occupational lead exposure have not

11 provided consistent evidence for associations

12 between blood lead and neurological effects,

13 I'm paraphrasing, has cognitive reserve may

14 compensate for the effects of lead.

15 Compensatory mechanisms may become

16 less affective with age, explaining the

17 consistent associations between measures of

18 accumulative lead exposure and neurocognitive

19 deficits.

20 So I found that logic a little hard

21 to understand. It somehow implies that bone

22 lead measures are done in a different age

Page 363

1 distribution than blood lead, which is not

2 really the case.

3 So there are a number of examples

4 where, in summarizing sort of the overview of

5 what's in the document, the logic gets a

6 little bit perverted, and I think it is

7 important to sort of go back and do a quality

8 of thought check, and make sure that what's in

9 there really makes sense. It may be cutting

10 and pasting, I don't know what happened.

11 And my only other comment is, I

12 didn't realize until looking at this section,

13 that growth was never covered in the human

14 health review although, it's covered in the

15 ecology review.

16 And I wondered why that was. There

17 are studies, old but studies looking at

18 stature and lead, especially in childhood

19 growth charts that see lead-related decrements

20 in childhood stature, which I think are

21 interesting and mechanistically tie into some

22 of what's thought to be lead's effect on bone.

Page 364

1 And I wondered if that was a

2 conscious choice, or an oversight. Because

3 seeing the information in the ecology and

4 realizing it was absent from the human review,

5 I thought was sort of an unusual omission.

6 And maybe because it's old data, it

7 wasn't included. But I wondered if anybody

8 could comment on that? So those are my two.

9 (Off microphone comment.)

10 DR. KORRICK: Yes, so maybe the

11 chapter, the miscellaneous outcomes, growth is

12 in there, okay. So it should just come

13 forward in Chapter 2. I didn't see it, but.

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

15 Lanno?

16 DR. LANNO: I think it's really

17 interesting to see the comparison of these

18 toxicities, modes of toxic action across all

19 the different groups. And along with that

20 comes, from my perspective, it's how do we

21 compare these?

22 And if we do, we have to

Page 365

1 standardize the units. And this is kind of

2 something that got under my craw a little bit

3 was, you know, if we're going to express

4 exposure dose, let's be consistent with it.

5 And I take you to maybe to Table 2-

6 6 there. And it was really, really

7 interesting because I'd never done much work

8 with the human parameters. But it sticks in

9 my mind, micrograms per deciliter is the blood

10 value. So as soon as we talked about birds at

11 41, I'm going, okay, that means something.

12 But if you look at the other, the

13 exposure dose column in that table. You've

14 got picomolar, nanomolar, micromolar, and part

15 per million.

16 And first of all, part per million

17 is not even an exposure dose. I mean, let's

18 at least put SI units and go to milligrams per

19 liter, or something like that for that.

20 And then I said, okay, well here's

21 a good chance to use HERO, so let's go and

22 look in the database and see what this part
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1 per million actually was in.

2 And so, if I go to this table here,

3 I'm going to this table here, okay. So it was

4 the studies of the second last line there,

5 endocrine disruption, and it states the dose

6 is 20 part per million acute, and there's two

7 references given.

8 And I went to one of them, and one

9 of them was actually the experiment that that

10 value came from, and it was in drinking water.

11 So then I went to the other one,

12 and it was in some other medium. None of

13 these are in air, so it's not really clear to

14 me. I mean we talk about context and

15 relevance again, so drinking water and an

16 effect, and then the other one was an in vitro

17 test and an effect.

18 And again, I think we really have

19 to be careful, if like as Dr. Wasserman

20 mentioned, if this is the only chapter

21 somebody is going to read, we have to be very

22 careful of the context of the exposure doses

Page 367

1 as you express them in this chapter.

2 And I would suggest that, you know,

3 at least SI units, molar is best because

4 you're not dealing with a massive chemical, a

5 massive lead at the site of toxic actions, the

6 number of moles of the element at the site of

7 toxic action, interact with the biological

8 molecules. So, molar might be the best way to

9 express it, but at least SI units.

10 And one last comments, I see that

11 we go from human to ecological, and then we've

12 got all these great summary tables for the

13 human section. And we don't have those great

14 summary tables for the ecological section. 

15 It'd be nice to have them if we could.

16 And in the ecological section you

17 tend to forget to include references, so

18 people can go to the paper where the data

19 might have been presented. And there's very

20 few measures of exposure dose that are

21 presented in the ecological section.

22 So I think maybe we're getting the

Page 368

1 short shrift there in the ecological section,

2 in terms of the interpretations. So maybe

3 that would be something to look at when you go

4 through it again.

5 DR. FREY: Okay, thanks. Dr.

6 Rabinowitz?

7 DR. RABINOWITZ: Okay. In the

8 interest of time, I'll try and be a little

9 brief. Of course I know everybody reads

10 carefully everything I type, so I'll try and

11 talk here instead about substantive things

12 more.

13 And it was irresistible to try and

14 compare the welfare system, the ecosystem with

15 the humans, and the question is, it's just

16 irresistible, I'm glad you did it, the

17 question is doing it right.

18 And it's a matter of aligning the,

19 so the doses and exposures are all kind of

20 correspond. There's hazards in doing this,

21 but they all become apparent to you and you'll

22 highlight it for us.

Page 369

1 I guess my main concern has to do

2 with causality. And a lot of that really

3 appears first in the document, back in Chapter

4 1, and on Page 19. But with your indulgence,

5 could I address it here?

6 And I just, let me find my -- I

7 guess it has to do with, let me just find

8 myself here, excuse me. It has to do with

9 whether lead is the independent risk factor,

10 maybe I can just read what I wrote here.

11 I wish efforts could be made to

12 show the extent or strength of confounding, in

13 the context of the effect size for lead. And

14 for the whole model's predictive power, the R15 squared.

16 The presentation the researchers

17 they cite, and the journal reviewers they must

18 satisfy, seem content to show that lead as a

19 non-zero coefficient in multiple regression

20 models.

21 For example, and for children, and

22 the mental performance. But because of the
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1 extent of the confounding, this is different

2 than showing that lead is an independent risk

3 factor.

4 And these other risk factors often

5 share considerable variants with lead,

6 particularly in some of the high risk

7 populations, lead exposure and other risk

8 factors coexist.

9 The relative size of this non-zero

10 coefficient, the size of the lead effect,

11 should be shown in terms of the total model,

12 R-squared, the goodness of fit, some measure

13 that.

14 How good is the model's fit and

15 does adding a lead term improve the model's

16 goodness of fit, having nested models. I'm

17 not a statistician, but when people tried to

18 teach me things, they thought that I would be

19 part of the standard.

20 Is to see if you add lead to a

21 model, does it improve the model's goodness of

22 fit, to show a model with a lead term, without

Page 371

1 a lead term, don't just satisfy us, and show

2 a non-zero lead term.

3 I would like to see just lead

4 improved the model's goodness of fit. Do the

5 other coefficients of the other risk factors

6 change significantly.

7 Those are the types of things I'd

8 like to see when people say that lead is a

9 risk factor, especially these low levels. My

10 concern really is that these increasingly low

11 levels and, you know, I've been at this long

12 enough, I think that everything now is low

13 level.

14 Where lead effects are small, blood

15 lead can still be measured relatively

16 accurately, usually to at least two

17 significant figures.

18 Where other stronger variables such

19 as maternal education, the richness of a

20 child's home environment, it's hard to measure

21 it to two significant figures. And also,

22 they've often entered it to the models as

Page 372

1 broad categorical variables where lead is

2 allowed to be a continuous variable.

3 So for these reasons, I'm sorry,

4 but I still remain skeptical that at these

5 rather low levels, the effects that are

6 attributed to lead are fully caused by lead.

7 And besides that, there's a few

8 other comments I have mostly about, well I

9 just, how some tables could be made better,

10 some things could be made better.

11 The work that Arthur Chamberlain

12 did, that you report here, that fell into the

13 chapter of ethyl lead, by the time he burned

14 and exposed it to people, it's really

15 inorganic lead, so maybe that needed to be

16 shifted. Things like that, so thank you.

17 DR. FREY: Okay, thank you. Next,

18 Dr. von Lindern?

19 DR. von LINDERN: Thank you. I have

20 the distinction of having stood between us at

21 lunch, and now --

22 (Laughter)

Page 373

1 DR. FREY: We planned carefully.

2 DR. von LINDERN: So I'll hold it

3 to two main comments. One, I really liked

4 this chapter and I think it was a courageous

5 presentation.

6 And in, kind of, the history of

7 these documents and this process, I think it's

8 an important event because you are trying, for

9 the first time to bring the ecological and

10 human health material together, and I think

11 that's an advancement for EPA and for the

12 science.

13 That being said, you're bringing

14 two disciplines that haven't greatly

15 cooperated over the years together, and

16 they're both not going to like it. So you're

17 going to get a lot of criticism there, but

18 that should be constructive criticism that

19 should be a starting point for building this

20 as a process in EPA, so I commend you for

21 that.

22 I think it was excellently edited. 
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1 It was a good read. And I'm not used to

2 giving these many compliments, so now I'll

3 move to the other part.

4 And this isn't a criticism of the

5 chapter so much, as it is perhaps the status

6 of knowledge right now, or what information

7 was sought, only for 72 pages of this chapter

8 address exposure.

9 But exposure is a critical part of

10 doing the overall job here, and doing the risk

11 assessment that we'll discuss tomorrow. And

12 is that because we haven't looked at that

13 information or is that because there's no new

14 information, or is that because there's no

15 information about contemporary exposures in

16 the country.

17 So I beat that horse one more time,

18 and then I yield. Thank you.

19 DR. FREY: Okay, thank you. Is

20 there a question on this point, or?

21 DR. CORY-SLECHTA: It was on

22 Michael Rabinowitz's comment.

Page 375

1 DR. FREY: Okay. All right, why

2 don't you go ahead then?

3 DR. CORY-SLECHTA: Well, I guess

4 I'd like us to sort of consider the opposite

5 point of view, and Michael, and I would argue

6 some of the same things that David Bellinger

7 has argued. That in many of these

8 epidemiological studies, we completely

9 overcontrol.

10 So for example, if I go to the

11 Rochester Cohort database and I look at the

12 correlations between virtually, mother's IQ,

13 income, home score, you name it, they are so

14 highly correlated, they essentially all boil

15 down to one.

16 And yet we throw every single one

17 of those into every study, and we do it not

18 for a good biological rationale, we do because

19 everyone else did it, or it won't get

20 published if we don't put it in.

21 But I would argue that we probably

22 don't really appreciate the magnitude of the

Page 376

1 effect because we're so extensively over

2 controlling for all of the other things we

3 think are out there, that are all highly

4 related and boil down probably to SES.

5 DR. RABINOWITZ: I find myself

6 agreeing with you, that these are really all

7 wrapped up in some way, and that's why I think

8 it would be better for the reader to see it

9 with and without lead, and they can see the

10 extent of this confounding. Maybe it's over

11 controlled, you know.

12 DR. CORY-SLECHTA: Nobody presents

13 the correlations between all the other

14 covariants, that's the big, so.

15 DR. RABINOWITZ: Would nested

16 models help you in that circumstance?

17 DR. CORY-SLECHTA: What?

18 DR. RABINOWITZ: Would nested

19 models help you in that circumstance to

20 understand?

21 DR. CORY-SLECHTA: Yes, and no. 

22 There would be several ways to look at it I

Page 377

1 think.

2 DR. FREY: Okay. Dr. Weitzman?

3 DR. WEITZMAN: So I agree with much

4 of what's been discussed. I think that it's

5 really a remarkably well put together

6 document.

7 I think there's a metaphysical

8 question that has to be answered, which is,

9 whether it's a summary, it's an executive

10 summary that comes up front, or it's something

11 that comes later, and how one structures an

12 executive summary is often different than the

13 closing chapter or concluding chapter, in a

14 volume of this size.

15 I think that this would be a great

16 place to try new technological efforts since

17 this is going to be online to link people to

18 the myriad places where this heroic effort has

19 been undertaken to summarize a truly

20 voluminous literature.

21 So I do think that there are ways

22 to do that. And the only concrete objection
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1 that I had, I'm not sure that it applies to

2 both volumes that you provided to us, but it

3 certainly applies to Chapter 2.

4 There's one sentence that says that

5 there are studies that show associations

6 between lead in paint, and children's blood

7 lead levels. So I understand that the purview

8 of this exercise doesn't focus on paint or

9 children's homes.

10 But somehow it seems to do a

11 disservice to the most ubiquitous

12 environmental problem that confronts children,

13 namely lead, to have just one sentence that

14 says there's an association that's been shown.

15 So, yes there are multiple,

16 multiple, this is a multimedia exposure

17 problem, but it somehow seems disingenuous to

18 have that one sentence as enough.

19 DR. FREY: Okay. Any other

20 comments on Chapter 2? Rich?

21 MR. POIROT: I just wanted to echo

22 Ian's point about how useful I thought it was

Page 379

1 to really try to put the health and

2 environmental effects together.

3 You know, if for no other reason

4 then, you know, some of you may know, I've

5 been on a campaign for many years to try to

6 get the Agency to consider having separate

7 secondary standards for pollutants.

8 And in some cases, those have been

9 very well justified. But conversely,

10 secondary standards are almost always set

11 equal to the primary standards, even when

12 there's no justification whatsoever for doing

13 that.

14 You know, the most recent example

15 I think would be the secondary Sox NOx, now

16 we're going to have secondary standards for

17 NO2, I don't know. At any rate, I think that

18 this will really put you in a much better

19 position to draw those links and to establish

20 secondary standards that are justified, which

21 I think would be important.

22 CHIARMAN FREY: I wanted to make

Page 380

1 one comment and then, so I guess on the one

2 hand I was almost thinking we wouldn't have a

3 comment about where Chapter 2 was.

4 But it's kind of funny because I

5 guess, I don't know how many of us are also on

6 the ozone panel, there was big discussion on

7 the ozone panel about this issue for that ISA.

8 And what I am sensing from the

9 relative lack of commentary about it is, and

10 I guess a lot of positive comments about this

11 ISA's Chapter 2 is that, and maybe I'm over

12 interpreting.

13 But there was I think a general

14 comfort level with Chapter 2, where it was,

15 and kind of the general scope but, you know,

16 taking into account some of the comments we've

17 heard about need for consistent, kind of level

18 of detail and referencing to other parts of

19 the document, and then of technical issues

20 here and there.

21 But I think the question of

22 whether, you know, this is an executive

Page 381

1 summary, is it a summary, should it come early

2 or later in the document, inevitably comes up

3 I think for every ISA, for every criteria

4 pollutant review.

5 And I think, I guess I'm wondering

6 if anyone feels strongly that Chapter 2 needs

7 to be other than where it is, and kind of

8 other than what it is.

9 You know, I think there's some

10 value for the reader to have that early in the

11 document before you might, I guess get up the

12 courage to go look at Chapter 5, which is it's

13 own -- yes, and energy.

14 I guess I just want to get a sense,

15 because I think EPA would appreciate the

16 feedback and maybe the feedback from this

17 panel will be different than other panels,

18 which is fine.

19 DR. GOODRUM: I'll just quickly

20 respond that I think if it's -- well, where it

21 is, it's a good preview, especially given most

22 of the chapters have, there's an attempt to
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1 have a mini summary at the end of the chapters

2 anyway, so I don't feel a need for an overall

3 document executive summary.

4 DR. FREY: Okay. Yes, Cliff?

5 DR. DAVIDSON: Yes, I guess I agree

6 with that, but I think when I hear the words

7 executive summary, I think about, you know, a

8 small bite size piece that I can look at. And

9 Chapter 2 will never be a bite size piece,

10 it'll be voluminous in its own right.

11 But obviously, much shorter than

12 the whole rest of the document. So I kind of

13 like where it is as well, because I don't

14 think it looks like an executive summary.

15 DR. FREY: Yes, I think one other

16 aspect that maybe was more evident in this ISA

17 than in other pollutants, is the integrative

18 aspect, and particularly the human and eco, I

19 think as some people have already pointed out,

20 a nice improvement.

21 So I just wanted to echo some of

22 that for EPA's benefit because I think,

Page 383

1 certainly there's some things to revise there,

2 but by and large, it seems to be about where

3 it needs to be. And probably about the length

4 it has to be.

5 You know, I don't think an

6 executive summary is probably even realistic

7 for this document. Any other, I guess Dr.

8 Kosnett, you had something you wanted to tell

9 us.

10 DR. KOSNETT: Earlier when I had

11 made some comments about Chapter 5, I also

12 mentioned my concerns about the application of

13 the causal framework, and certainly that gets

14 recapitulated and summarized in Chapter 2.

15 So I hope that, to the extent

16 there's consensus that those concerns would be

17 raised in the comments on Chapter 2.

18 DR. FREY: Okay. Are we about out

19 of steam, from the panel? Anything else on

20 Chapter 2? If not, John, you have a --

21 DR. VANDENBERG: I very much

22 appreciate the discussion about Chapter 2, and

Page 384

1 again as you mentioned Chris, there was quite

2 a discussion about this with those on it.

3 We've been fortunate in that we've

4 got a pretty dynamic process. We can change

5 things, and so we consider all the detailed

6 comments as was asked, or a comment made

7 earlier, but we also consider the big picture,

8 kind of structural things.

9 And so, if you'll allow us, what I

10 might ask is for Mary Ross to share some of

11 thinking that's been going into what we've

12 been reacting to from the comments on the

13 ozone document, is that may help you get some

14 sense of the direction that we're going, and

15 it's some of the reframing of things.

16 And part of that I think is a

17 reflection of, even the sense here, is this an

18 executive summary, is this an integrated

19 overview, is this redundant, is it different,

20 what is it?

21 And so we're trying to rethink that

22 and think of what's the most effective way for

Page 385

1 us to communicate to perhaps a variety of

2 audiences.

3 And there are a variety of

4 audiences clearly, you know, different

5 audiences have different needs for

6 information. So if you'll give us just a

7 second, let me ask Mary to give her thoughts

8 on that.

9 DR. FREY: Yes, just I guess one

10 little comment about the ozone. My

11 recollection of the response to the relevant

12 charge questionnaire, was that that panel

13 actually didn't really have a consensus as to

14 what that Chapter 2 should be.

15 And among the opinions in that

16 panel were, comfort with kind of where it was,

17 which was analogous to what we're seeing here,

18 but yes, it would be interesting to hear, you

19 know, what your thoughts are moving forward.

20 DR. ROSS: Yes, because we heard

21 various executive summary, put it at the end. 

22 And so one of the things we've considered, and
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1 others actually independently have said, why

2 is this Chapter 2?

3 So we have considered merging

4 Chapters 1 and 2 into an over arching summary

5 that comes up front that's more than an

6 executive summary.

7 We might add then your snapshot, if

8 needed, for a long chapter. But we take a lot

9 of what's Chapter 1 and put it into two other

10 places.

11 And those would be a preface that

12 include the history of the pollutant, the

13 history of the NAAQS review, and the

14 legislative background that are specific to

15 that pollutant that are useful information,

16 but you don't necessarily have to read it to

17 get into the health and eco effects.

18 So that would be a preface that

19 would include what is now legislative and

20 historical information. And move the

21 causality framework into a preamble, since

22 that is actually applied across pollutants.

Page 387

1 Not unlike what's done for IARC,

2 for those of you familiar with the IARC

3 process. So then that would still be

4 available electronically, but it actually

5 diminishes Chapter 1 to about four or five

6 pages, that is specific to the pollutant.

7 This is lead. This is the standard

8 for lead. These are the policy relevant

9 questions. These are the literatures. The

10 parameters that would play a role in

11 developing this document, that lead right into

12 what is now Chapter 2.

13 We were going to test run that for

14 ozone. I guess we can ask you feedback on

15 whether you thought that would be useful here. 

16 Then Chapter 1 and 2 would become one thing at

17 the beginning of the document.

18 DR. FREY: Okay.

19 DR. VANDENBERG: So I think the

20 point is that we're actively thinking this

21 through, and trying to think of different ways

22 to frame it that would be as affective as

Page 388

1 possible, so your comments are very much

2 welcome.

3 DR. FREY: Yes, Dr. Wasserman?

4 DR. WASSERMAN: I think that if you

5 want to put the causal framework, like the

6 logic of the framework separate from the

7 results, that might work well.

8 But I actually like having your

9 causal determination as a separate piece, not

10 merged in with the history and the act and all

11 the legislative stuff, but just the

12 determination that this is a level one, and

13 this is a level four, and there's strong

14 evidence here. I like those things, gold

15 boxes that you can put something in.

16 DR. ROSS: And I'm sorry, I

17 misspoke, so the legislative, the history

18 would be in a preface, but all of the causal

19 determinations and the discussion of it would

20 remain. But the general structure of the

21 framework, the Hill criteria, and the things

22 would be in a side document that, since that's

Page 389

1 sort of the basis for determining it. But

2 definitely what's in Chapter 2 would stay in

3 the document. If that's, perhaps I --

4 DR. WASSERMAN: I just didn't want

5 to have that causal, your possible conclusions

6 merged in with the history of --

7 DR. ROSS: No, that wasn't what we

8 intended. We were trying to get them farther

9 apart.

10 DR. WASSERMAN: Yes.

11 DR. FREY: Well I think the lack of

12 the vehement opposition might be interpreted

13 as implicit support. I mean it sounds like

14 something worthwhile to experiment with.

15 And yes, I think the generic causal

16 framework that's in Chapter 1, you know, that

17 appears in every ISA, and making that a stand18 alone document that is consistent has a lot of

19 benefit.

20 But then as, I think you alluded to

21 some interpretation relative to each pollutant

22 is still useful, but that would still be in
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1 this new Chapter 1, so that sounds fine.

2 Okay, well I think we've gotten

3 through a day of charge questions on the ISA. 

4 So I think we're at the point in the agenda

5 that is labeled Summary and Action Items.

6 I think given the time, I do want

7 to adjourn at 5:30 and it's 5:22 now, so I

8 don't want to try to do a summary right now.

9 What I would like to do is just

10 remind the lead discussants if they could

11 please put together, whether you do it in

12 bullet form or paragraph form is fine, I'm

13 mainly interested in the content of what you

14 think the key consensus points are for your

15 charge question, and email that to me and

16 Aaron, preferably if you can by, not later

17 than 10 o'clock tonight.

18 I'd like to have a chance to take

19 a look through that. I would like possibly

20 tomorrow morning to just spend a little bit of

21 time reviewing that, because I think whatever

22 we can do face to face here, could save us a

Page 391

1 lot time in a teleconference later on.

2 And we will have to have a

3 teleconference to follow on, to review, you

4 know, the full draft of the letter to the

5 administrator, the response to charge

6 questions for this review of the ISA.

7 So the more we do to kind of put

8 that in, at least content before we adjourn

9 from this meeting in our TP, the better. Yes?

10 (Off microphone comment.)

11 DR. FREY: Yes, I'll get to that. 

12 Are there any questions about what I'm asking

13 in terms of the response on the charge

14 questions? Does that seem clear? Everyone

15 know who they are, who's, I made a list.

16 It includes Drs. Kosnett, George

17 Allen, Rich Poirot, von Lindern, Pounds,

18 Goodrum, Cory-Slechta, Korrick, Stubblefield. 

19 I can't read my writing. Wait, now I should

20 be able to figure out who that is.

21 PARTICIPANT: Everyone with an

22 asterisk.

Page 392

1 DR. FREY: Everyone with an

2 asterisk. Let's see Stubblefield, Weitzman,

3 that's what I couldn't read, Davidson and

4 Wasserman. Yes, so all of you are on the hook

5 for homework assignment.

6 But all of your co-discussants

7 should please make, if you haven't already

8 provided your written comments, or if you

9 revised your written comments, please get that

10 to your lead discussant on each of the charge

11 questions your on, and that'll help them write

12 the summary.

13 Tomorrow we start at 8:30 sharp. 

14 We will have a presentation from Brian Hubble

15 and others from EPA's Office of Air Quality

16 Planning and Standards on the exposure and

17 risk assessment scope and methods plan.

18 Do we have any public comments? 

19 Right now, we don't have any signed up. So

20 then we'll have discussions on health risk

21 issues, and welfare risk issues related to

22 that scope and methods plan.

Page 393

1 And that will be a consultation so

2 we do not need to present, or produce a

3 consensus report. So our work tomorrow's a

4 little bit, maybe more straightforward in that

5 regard.

6 I saw a list of all the airline

7 departure times. I think 99 percent of us are

8 here until at least noon, maybe one exception,

9 and I think may of you had flights around 2:30

10 or so.

11 So we're scheduled to go until

12 12:30 tomorrow, and as I said, you know, if we

13 can I do want to use some time tomorrow

14 morning to look over the Response to Charge

15 Questions.

16 So if I can get your input tonight,

17 if things go well, maybe we'll have a rough

18 draft of the content of the Response to Charge

19 Questions that we can hand out first thing

20 tomorrow.

21 You could take a quick look at it

22 when you come in, and if there are any content
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1 issues there, we can try to address that. We

2 don't need to do all the wordsmithing. Yes?

3 (Off microphone question.)

4 DR. FREY: For tomorrow's ERA, if

5 you have pre-meeting comments, you can submit

6 those. There's no other specific homework for

7 the REA. Any other questions? Anything from? 

8 I guess John, and did we meet your needs, or

9 do you have any last questions, things that

10 you were hoping to hear that you didn't hear

11 about?

12 DR. VANDENBERG: No, I would just

13 like to extend my great appreciation. This

14 has been very, very helpful. We appreciate

15 the time and energy, and we will very much

16 appreciate your written comments as well. We

17 do go through them very carefully. So thank

18 you, really thank you very much from all of

19 us.

20 DR. FREY: Yes, actually maybe

21 along that line, there was in the

22 administrative meeting, there was some, I

Page 395

1 think new members who were asking, what

2 happens to our comments?

3 And I assured the panel that EPA

4 does take them very seriously, and certainly

5 anything that we put in the letter to the

6 administrator, or in the Consensus Response to

7 the Charge Questions, I think EPA has a pretty

8 high burden either to respond to those or come

9 back with a pretty good reason why it wasn't

10 possible to do that.

11 And then also, that EPA does look

12 through all the individual member comments,

13 and I think that's a fair statement.

14 DR. VANDENBERG: That's correct.

15 DR. FREY: Okay. Yes?

16 DR. GOODRUM: A question, if we

17 included some charts along with our text

18 comments, would you like us to attach Excel

19 files?

20 DR. VANDENBERG: If you attach the

21 chart that you generated?

22 DR. GOODRUM: Yes.

Page 396

1 DR. VANDENBERG: Or a chart that

2 you lifted from part of --

3 DR. GOODRUM: Yes, as part of our

4 notes. If we generated charts to explain a

5 concept?

6 DR. VANDENBERG: No, I don't --

7 DR. GOODRUM: No?

8 DR. ROSS: I don't know that we

9 need the Excel file unless you wanted us to do

10 something with it. But I mean the

11 presentation.

12 DR. FREY: Okay. Well, I think

13 with that we're going to finish early. It's

14 5:28, and we're adjourned.

15 MR. YEOW: We can be adjourned.

16 (Whereupon, the above-entitled

17 matter went off the record at 5:29 p.m.)

18

19

20

21

22
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2004 261:10

2005 129:7 301:14

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2014 29:14

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