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### U.S. ENVIRONMENTAL PROTECTION AGENCY CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE (CASAC) LEAD REVIEW PANEL

+ + + + + PUBLIC MEETING + + + + + TUESDAY, APRIL 10, 2012

The committee met in Salon B of the Marriot at Research Triangle Park, 4700 Guardian Drive, Durham, North Carolina, at 8:30 a.m., Dr. H. Christian Frey, Chairman, presiding.

PRESENT: DR. CHRISTOPHER FREY, Chair MR. GEORGE A. ALLEN DR. HERBERT ALLEN DR. RICHARD CANFIELD DR. DEBORAH CORY-SLECHTA DR. CLIFF DAVIDSON DR. PHILIP E. GOODRUM

DR. SEAN HAYS* DR. PHILIP HOPKE DR. CHRIS JOHNSON DR. SUSAN KORRICK DR. MICHAEL KOSNETT DR. ROMAN LANNO MR. RICHARD L. POIROT

DR. JOEL G. POUNDS DR. MICHAEL RABINOWITZ DR. WILLIAM STUBBLEFIELD DR. IAN VON LINDERN DR. GAIL WASSERMAN MR. AARON YEOW, DFO* MR. EDWARD HANLON, Acting DFO DR. VANESSA VU, Director, SAB Staff Office *Via telephone202-234-4433 Neal R. Gross & Co., Inc. Page 2

C-O-N-T-E-N-T-S Page Convene Meeting and Welcome 3 Review of Agenda 8

EPA Updates on the Lead NAAQS

Background 19

Update on Lead Monitoring Network and Federal Reference Method Research Activities 28 Lead Emissions from Piston Aircraft 80

EPA Presentation on Revisions to the Draft Lead Integrated Science Assessment 92 Discussion of EPA Charge Questions Chapter 3 - Source to Concentration 123 Chapter 4 - Exposure, Toxicokinetics and Biomarkers 176

Chapter 5 - Integrated Health Effects of Lead 228

Chapter 6 - Potentially At-Risk Populations 300

Chapter 7 - Ecological Effects of Lead 319

Preface, Preamble, Executive Summary 351 (Chapter 1) and Integrative Summary (Chapter 2)

Summary and Action Items Page 3

1 P-R-O-C-E-E-D-I-N-G-S 2 (8:30 a.m.) 3 MR. HANLON: Good morning, 4 everyone. I'm Ed Hanlon, the Designated 5 Federal Officer or DFO for this meeting of the 6 EPA Clean Air Scientific Advisory Committee or 7 CASAC Lead Panel's review of the Integrated 8 Science Assessment, second external review 9 draft for National Ambient Air Quality

10 Standards. Aaron Yeow is the DFO for the 11 CASAC Lead Panel, but was not able to attend 12 this meeting. So I'm filling for Aaron just 13 for this meeting. 14 One member of the panel, Dr. 15 Michael Weitzman, was not able to participate 16 at this meeting. Another member, Dr. Sean 17 Hays, will be participating via

18 teleconference. The CASAC Lead Review Panel 19 is a Federal Advisory Committee, and by EPA 20 policy, its meetings and deliberations are 21 held as public meetings that meet the 22 requirements of the Federal Advisory Committee Page 4 1 Act, also known as FACA. 2 Through the EPA CASAC, the Lead 3 Review Panel is empowered by law to provide

4 advice to the EPA Administrator. The

5 discussions and substantive deliberations of 6 the CASAC Lead Review Panel, its interactions 7 with the public and the agency, are conducted 8 in sessions where I, as a DFO, am present to 9 ensure the requirements of FACA are met. 10 FACA also requires that as DFO for 11 this meeting I maintain records of 12 deliberations of the committee, make 13 publically available the meeting summaries and 14 provide opportunities for public comment. The 15 minutes of this meeting are being taken to

16 summarize discussions and action items in 17 accordance with requirements under FACA. 18 These minutes will be certified by the Chair, 19 Dr. Chris Frey.

20 The CASAC Lead Review Panel draft 21 advisory report will be forwarded to the

22 chartered CASAC for their consideration and Page 5 1 approval. No sets of written public comments 2 have been received to date for the panel's 3 consideration for this review. Also, no 4 members of the public have requested to 5 present oral comments during today's meeting.

6 And I want to remind all at the 7 meeting today of the status of the panel's 8 compliance with federal ethics laws. The SAB

9 staff office has determined that there are no 10 conflicts of interest or appearance of lack of 11 impartiality issues for any of the CASAC Lead

12 Review Panel members. 13 Dr. Vanessa Vu, Director of our 14 SAB staff office will now make some opening 15 remarks. Thank you. 16 DR. VU: Thank you, Ed. Good 17 morning. I'm Vanessa Vu. I'm the staff 18 director of the EPA Science Advisory Board. 19 It's my pleasure to welcome everybody to the 20 public meeting of the Clean Air Science 21 Advisory Committee Lead Review Panel.

22 First I want to thank Dr. Chris202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 Frey, members of this distinguished panel for 2 your time and public service to EPA in 3 rendering your independent scientific advice 4 on scientific issues related to the agency's 5 revision, consideration of revision of the 6 National Ambient Air Quality Standards for

7 lead. 8 Your advisors actually will go 9 through the chart of CASAC for approval before 10 the newer report will be transmitted to the 11 administrator. I very much appreciate your 12 time and effort for preparing for this 13 meeting. And again I want to thank you for 14 your coming to North Carolina for this face to 15 face meeting. 16 Today you'll also receive many 17 presentations from EPA's office of air 18 quality, OAQPS in office of air and radiation 19 and presenting to you about the status of the 20 updates regarding the lead NAAQS revision. I 21 want to take, also express my thanks to 22 members of the office of air and radiation, Page 7 1 headed by Ms. Lydia Wegman, Dr. Diedre Murphy

2 and several other folks from the office of ORD 3 as well including Bob Vanderpool from the EPA 4 national exposure research lab and the Office 5 of Transportation Air Quality, Dr. Marion 6 Hoyer.

7 Several of these folks will be 8 here in person this morning and will give you 9 presentations. And of course the main review 10 of this next two days' meeting is involving 11 the second draft Integrated Science 12 Assessment. And you'll be hearing from 13 colleagues from the office of research and 14 development headed by Dr. John Vandenberg. 15 And I appreciate your time and 16 effort, along with all of your staff and 17 contractor personnel, to be present so that 18 CASAC panel will have an opportunity to ask 19 clarification questions during the next two 20 days for deliberation. And last but not 21 least, I'd like to thank my staff. Ed Hanlon 22 will physically be here to serve as a Page 8 1 Designated Federal Officer for this review 2 meeting. And Aaron Yeow, who is the DFO for 3 this panel, who is available on the phone 4 should anybody wish to have any questions for 5 Aaron. With that, I'd like to turn the 6 meeting over to Dr. Chris Frey. Thank you. 7 DR. FREY: Okay. Thank you, 8 Vanessa and Ed. And good morning to the CASAC 9 Lead Review Panel and to the presenters from 10 the EPA and members of the public who are in 11 the audience. We have a busy agenda today. 12 Vanessa's covered a lot of the agenda related 13 to the presentations that we'll be receiving 14 this morning. So I won't repeat that. 15 I do want to talk briefly about 16 what we're going to do today as a panel. So 17 EPA will be presenting throughout most of the 18 morning on various topics related to the lead 19 NAAQS and to updates that we had requested in 20 our last meeting regarding the key sources of 21 lead emissions and exposures. 22 As has been mentioned, we don't Page 9 1 currently have any public commenters. So we 2 will begin our deliberation at the time point 3 in the agenda that's currently listed for 4 public comments, which is after the morning

5 break. 6 And then we'll briefly talk about 7 the charge questions in their entirety and 8 then we'll begin going through the charge 9 questions in the order that, we'll start with 10 Chapter 3 on Source to Concentrations and 11 George Allen is the lead discussant for that. 12 And as we go through each charge 13 question, please keep in mind that our 14 ultimate goal as a panel is to produce a

15 letter to the administrator that summarizes 16 the key results of our review. And we will 17 attach to that a consensus response in more 18 detail to each charge question. And then in

19 addition we will have an attachment that 20 contains the comments of the individual panel

21 members. 22 So I think most of you have202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 submitted pre-meeting comments. You will have 2 an opportunity to revise those comments before 3 they're finalized for incorporation into the 4 transmission that goes to the administrator. 5 Each group that's working on a 6 charge question has a homework assignment 7 tonight which is to exchange information so 8 that either by late tonight or early tomorrow 9 morning you have a first draft of the 10 consensus response to the charge question. I

11 would like to have a chance to review that and 12 maybe briefly discuss it with the panel 13 tomorrow morning just to make sure we iron out 14 anything that needs to be ironed out before we 15 adjourn tomorrow at lunchtime. 16 For the lead discussants, as your 17 charge question is being discussed, please 18 think about what are the top, say, three to 19 five bullet points that ought to be conveyed 20 into the letter to the Administrator, keeping

21 in mind that I think a shorter letter often 22 has more impact than a long letter. So if we Page 11 1 can keep the letter to the Administrator to 2 two to three pages, not more than four pages, 3 that would be I think the goal to aim for. 4 Which would mean that we're looking at maybe 5 roughly a paragraph of content per charge 6 question that goes into the letter to the

7 Administrator. 8 So those should be really the 9 truly key points. And those points will be 10 reinforced by the more detailed response to 11 the charge question. And then that will be 12 further supported by the individual panel

13 member comments. 14 So anything that's an extremely 15 high level of detail, you can usually reserve 16 that for individual panel member comments. 17 Things that are kind of broad, conceptual with 18 some supporting detail would go in the charge 19 question response and really the key points 20 that the higher level administration should be 21 aware of go in the letter. 22 So for example, George, to put you Page 12 1 on the spot, as you're discussing Chapter 3 if 2 you think of well what are the key points 3 about Chapter 3 that should go in the letter

4 to the administrator? And then what are the 5 key points that should go in the response to 6 the charge question? 7 And then George is of course 8 supported by Cliff Davidson, Phil Hopke, Chris 9 Johnson and Rich Poirot on Chapter 3. The 10 five of you will want to interact throughout 11 the day or this evening either face to face or 12 by e-mail to come up with a first draft 13 response to that charge question. 14 And just as a reminder, the CASAC

15 Lead Review Panel deliberations need to be 16 done in the public. So anything that involves 17 the entire panel must be done in the public. 18 It is okay for a limited number of members of 19 the panel to interact on drafting the response 20 to the charge questions. Any e-mail, however, 21 that you send must be CC'd and I would 22 recommend CC'ing that to both Aaron Yeow and Page 13 1 Ed Hanlon for the purposes of today's meeting. 2 Okay. So then we will go through 3 Chapter 3, then Chapter 4, 5, 6 and 7. And 4 then we'll come back to the preface, preamble, 5 executive summary and integrative summary, 6 that includes Chapters 1 and 2. And as we go 7 through Chapters 3 through 7, there may be 8 things that come up that have implications for 9 modifications to the Executive Summary and the 10 Integrative Summary. 11 And so I would just ask that the

12 lead discussants for that ladder who are Cliff 13 Davidson and Michael Kosnett, try to keep some 14 notes on, you know, is there anything that was 15 said about, you know, Chapter 3, Chapter 4, 5, 16 6 or 7 that has implications for Chapters 1 17 and 2. And maybe be prepared to try to 18 incorporate that in your comments. 19 And likewise those of you are 20 discussants on Chapters 3 through 7, it would 21 help as you summarize your response to the 22 charge question to also think about which of202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 these points needs to be reflected in Chapters 2 1 and 2. Okay. Having said that are there 3 any questions about the process from members 4 of the panel? I think we've been through this 5 before so hopefully it's familiar. 6 I did want to take just a minute 7 to quickly go around the room and have 8 introductions. I think we've worked together 9 and know each other, but it's always nice to 10 just say hello and reinforce -- we haven't

11 seen each other in a little while. And I'll 12 start just to illustrate by brief just name 13 and rank and organization. 14 So I'm Chris Frey. I'm a 15 Professor of Environmental Engineering at NC 16 State. And Dr. Herb Allen, could you start us 17 off and then we'll go around the room

18 counterclockwise? 19 DR. ALLEN: I'm Herb Allen,

20 Professor Emeritus of Civil Environmental 21 Engineering at the University of Delaware. 22 DR. JOHNSON: I'm Chris Johnson, Page 15 1 Professor and Chair of the Department of Civil 2 and Environmental Engineering at Syracuse 3 University.

4 DR. STUBBLEFIELD: I'm Bill 5 Stubblefield. I'm a professor in the 6 Department of Environmental and Molecular 7 Toxicology at Oregon State University. 8 DR. LANNO: Roman Lanno, Professor 9 of Evolution, Ecology and Organismal Biology 10 at Ohio State University. 11 DR. DAVIDSON: Cliff Davidson,

12 Professor of Civil and Environmental 13 Engineering at Syracuse University.

14 DR. VON LINDERN: I'm Ian Von 15 Lindern with TerraGraphics Environmental 16 Engineering from Moscow, Idaho.

17 MR. POIROT: I'm Rich Poirot. I'm 18 with the State of Vermont Agency of Natural

19 Resources.

20 DR. CORY-SLECHTA: I'm Deborah 21 Cory-Slechta from the University of Rochester

22 Medical School. Page 16 1 MR. ALLEN: Thank you. George 2 Allen with NESCAUM, which is a multi-state 3 organization in the northeast U.S. 4 DR. HOPKE: Hi. I'm Phil Hopke.

5 I'm the Director of the Institute for a

6 Sustainable Environment at Clarkson 7 University. 8 DR. CANFIELD: I'm Rick Canfield,

9 Division of Nutritional Sciences at Cornell 10 University. 11 DR. HAYS: Sean Hays from Summit 12 Toxicology.

13 DR. KORRICK: Susan Korrick from

14 the Harvard Medical School and Harvard School

15 of Public Health and Environmental 16 Epidemiology.

17 DR. KOSNETT: Hi. I'm Michael 18 Kosnett. I'm a medical toxicologist and 19 occupational medicine physician at University

20 of Colorado School of Medicine and the

21 Colorado School of Public Health. 22 DR. GOODRUM: Hi. I'm Philip Page 17 1 Goodrum. I'm with Cardno ENTRIX in Syracuse,

2 New York.

3 DR. POUNDS: I'm Joel Pounds at 4 the Department of Energy's Pacific Northwest 5 National Laboratory. 6 DR. RABINOWITZ: Good morning. 7 I'm Michael Rabinowitz. I'm a retired isotope 8 geochemist. I live in Rhode Island. 9 DR. FREY: Okay. Thank you. And 10 the real purpose of that was to get practice 11 using the microphones. And as a reminder, 12 please turn off your microphone when you're 13 done. I think there's only a limited number

14 that can be on at one time. 15 Okay. So with that I would like 16 to turn over the floor to Ms. Lydia Wegman and 17 Dr. Diedre Murphy. Are you both ready? Okay, 18 the floor is yours. 19 MS. WEGMAN: Thank you very much, 20 Chris. We very much appreciate everyone being 21 here. My name is Lydia Wegman. I'm the

22 Director of the Health and Environmental202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 Impacts Division at the Office of Air Quality 2 Planning and Standards, which is part of the

3 Office of Air and Radiation at the U.S. EPA.

4 And our office works on the risk 5 and exposure assessment, the policy assessment 6 and works closely with ORD as we move forward 7 to consider the lead standard. And we very 8 much appreciate all the work that you have

9 done to date and all the work that we 10 anticipate you doing as we continue forward in

11 this review. 12 I just wanted to give you a brief 13 overview, which you may have had at the first 14 meeting. I'm sorry I missed your first 15 meeting, but I'm very glad to be here today. 16 Of the review process itself and the schedule

17 for this review. And I want to thank Dr.

18 Vanessa Vu and the SAB staff office for 19 getting this all organized today. 20 So this is our graphic of the 21 review process for an air quality standard. 22 You may have, many of you have certainly seen Page 19 1 this before. If you go across the top it says 2 Integrated Science Assessment up there in the

3 middle. 4 And that is obviously what is 5 being reviewed today, the second draft of 6 that. And right under it, of course, is the 7 work that you are doing and then the risk and 8 exposure assessment, which we have spoken to 9 you about and we'll talk a little more about 10 it tomorrow and how we're going to work in the 11 risk and exposure assessment from the last

12 review into this review. 13 The next step is the policy 14 assessment, which we will also be talking 15 about tomorrow. Diedre will be talking about 16 that tomorrow. Zach Pekar will be talking 17 about the risk and exposure assessment, I 18 should say, and how it will feed into the 19 policy assessment. 20 Once we get through all of that, 21 and I'll show you the schedule for it in a 22 minute, we then move into the decision making Page 20 1 phase at the agency. And that involves going 2 to the administrator, taking your advice, 3 which will be extremely important to the 4 administrator as she considers what steps to 5 take as we move forward onto a proposal

6 notice. 7 We have an interagency review 8 process which is run by the Office of 9 Management and Budget. So after the agency 10 proposal is drafted it goes to the Office of 11 Management and Budget for review by all 12 federal agencies that might be interested in 13 this action. We then issue a proposal and 14 then coming along the bottom tier here we have 15 a public hearing, an opportunity for comment 16 on the proposal. 17 And then we go into the final 18 rulemaking phase where we take the comments 19 and consider the agency and the administrator

20 will consider what the final action should be. 21 Again, there is interagency review for that 22 step. And then the final decision. Page 21

1 So you can see why the Clean Air 2 Act envisions a five-year process for all of 3 this activity. And in most cases we have 4 succeeded in taking more than five years. Not 5 always, not in the last lead review once we 6 got started. But we certainly need the full 7 five years in most cases. 8 It's a great deal of work and a 9 great deal of work on your part since the 10 integrated science assessment, the risk and 11 exposure work and the policy assessment are 12 all reviewed by you multiple times. So where

13 are we in this lead review. 14 As you can see in red, we are, you 15 are reviewing the second draft of the science 16 assessment today and tomorrow. Then we've 17 already done the planning document and as you 18 know, we're not doing a new risk and exposure

19 assessment in this case. 20 But we will be folding in the 21 results of the last risk and exposure 22 assessment to the first draft of the policy202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 assessment which we expect to get to you in 2 September of 2012. So that's not too far from

3 now. 4 And then we are hoping for a 5 meeting with you in October of 2012 to go over 6 that first draft. And you can see that our 7 plan is to have a proposed rule out in January

8 of 2014 and a final rule in November of 2014.

9 So that's the schedule as we envision it from

10 here on out.

11 And then the last slide I'll do 12 before turning this over to Diedre, you've 13 heard this, Diedre is going to recap what was 14 done in the 2008 rulemaking. And then we have

15 two other EPA folks here. 16 Kevin Cavender will be coming 17 forward to talk to you about the monitoring 18 network and methods. And Marion Hoyer is here 19 from our Office of Transportation and Air 20 Quality to talk about aircraft emissions 21 information. And I'm sorry I skipped Bob 22 Vanderpool, there he is, yes. And Bob will be Page 23 1 here to talk about methods, lead monitoring

2 methods. 3 So we've got all three of these 4 excellent folks here today. And then 5 tomorrow, as I said, Zach Pekar and Diedre 6 will be here to talk about the way in which 7 the risk and exposure information will be 8 presented in the policy assessment. So with 9 that I'm going to turn it over to Diedre. 10 DR. MURPHY: And I'll just take a 11 few minutes here to recap where we were at the 12 end of the 2008 review to sort of help the 13 stage for the monitoring updates that you'll 14 hear subsequent to that. So it's the next 15 slide, just briefly recap the decisions on the

16 different elements of the standard. Most 17 importantly, in the last review we concluded 18 that the previous standard of 1.5 microgram 19 per meter cubed was not requisite to protect 20 public health with an adequate margin of 21 safety. 22 And so in revising the standard, Page 24

1 EPA retained the indicator as lead in total 2 suspended particles and that was due to 3 reflection of the knowledge that lead 4 particles of all sizes put health risks. 5 Because in the case of the lead standard, 6 we're interested in multiple pathways of 7 exposure, not just the inhalation pathway of 8 exposure.

9 We also -- we revised the 10 averaging time and form to a maximum not to be 11 exceeded rolling three month period 12 calculated from three consecutive monthly 13 averages. And this gives equal weight to all 14 three month periods within the year and equal 15 weight to each month within each period, which 16 differs from the last averaging time and form 17 which was a calendar quarter. This also gives

18 us three -- 19 12 three-month averages for comparison to the 20 NAAQS rather than the four which we had 21 previously.

22 We also revised the level from 1.5 Page 25 1 to 0.15 microgram per meter cubed. And that 2 decision was guided by an air related I.Q. 3 loss framework that integrated evidence from 4 relationships between lead and air and lead in

5 children's blood and lead in children's blood 6 and I.Q. loss. The quantitative risk

7 assessment results were also deemed to be 8 supportive of the framework estimates and 9 provided support for that decision.

10 So overall the administrator

11 concluded that the combination of decisions on 12 indicator averaging, time, form and level 13 provided the requisite public health 14 protection, including health of sensitive 15 groups with an adequate margin of safety. So 16 then I'm just going to take a few more minutes 17 with regard to the consideration of indicator 18 in the last review as a background piece for 19 the conversations coming subsequent with 20 regard to the monitoring network and methods 21 that you'll hear updates on. 22 So with the proposed rulemaking in202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 the last review, we proposed two different 2 options on indicator. We proposed one option

3 that we would retain the lead in TSP 4 indicator, but allow the use of lead in PM10 5 data with the use of scaling factors. And so 6 we proposed that we could adopt a default 7 scaling factor from within various ranges. 8 From within a range of one to two 9 for source oriented sites in recognition that 10 source oriented sites were more likely to have 11 larger particles of lead and we proposed a 12 range for non source sites of 1 to 1.4 or a 13 larger range of 1 to 1.9. And we solicited

14 comments on all of this information.

15 And the information that we 16 proposed was based on the little available

17 data that we had at that time for those 18 different types of sources. We also allowed19 in that option for the development of site20 specific scaling factors. 21 The second option that we proposed 22 and sorry, proposed and solicited comment on, Page 27

1 was to revise the indicator to let in PM10 2 with a corresponding adjustment to the level 3 of the standard in recognition that it would 4 not be capturing all of the lead bearing 5 particles in the atmosphere. And so we took 6 comment on both of those options as well as on 7 the different aspects of both of those options 8 soliciting comment on information that might 9 be available on relationships between those 10 different size classes of lead bearing 11 particles. 12 The comment was overwhelmingly in 13 favor of retaining the indicator of lead in 14 TSP and the information that provided did not 15 give us any stronger information about 16 relationships between the two size classes at 17 different types of locations. And so our

18 final decision was to retain the indicator of 19 lead in TSP, however, we also in the decision

20 allowed for the use of lead in PM10 methods 21 without adjustments at particular sites.

22 At sites that were distant from Page 28 1 sources where we did not expect there to be

2 source contributions. But also at sites where

3 we had evidence that there would not be ultra 4 course particles bearing lead there. 5 So with that backdrop I think 6 we'll take a minute to modify the people up in 7 front of you and we'll bring up Kevin Cavender 8 and Bob Vanderpool to talk about monitoring

9 network and methods. 10 MR. CAVENDER: Thank you all for 11 having me out today. My name's Kevin Cavender 12 and I was the lead on the monitoring aspects 13 of the review for the last review. And I just

14 want to talk a little bit about some of the 15 findings that we had and the changes that we 16 made in order to implement the new NAAQS. 17 DR. FREY: Kevin, I'm sorry. Just 18 a quick, when you're on a slide could you 19 please state the slide number?

20 MR. CAVENDER: Sure. So I've 21 moved onto slide eight. I went too far on my 22 own copy here. Here we go. So when we Page 29

1 started the review we started looking at the 2 state of the lead monitoring in the US and we

3 found some issues. And so this is what slide 4 eight wants to talk about, some of the things 5 that we found when we started looking at it.

6 First off we looked at the network 7 design requirements, basically where 8 monitoring was required by our regulations. 9 And one of the things that we noted early on 10 when we were looking at the data that we felt11 that the only places that we would find non12 attainment, based on our review of the data

13 was near sources of lead. So this is unlike 14 ozone and PM2.5 where it's a very regional 15 pollutant, this is more of a source-oriented 16 pollutant that at least at this level of the17 standard we're only likely to find non18 attainment around sources of lead. 19 Then we looked at our requirements 20 and we saw that our requirements and the 21 network itself was probably ill suited to 22 identify those locations. We needed to revise202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 the requirements to capture all the sources 2 with the potential to exceed the NAAQS. And 3 one of the things that we heard from CASAC and 4 others through our comments is that we should 5 try to work in lead in PM10 in some way that 6 that sampler was a nice sampler and we should 7 be using it. 8 One other thing we identified was 9 that for the secondary standard in rural areas 10 of the improved network that we have includes 11 speciation of PM2.5 and that gives us a lead

12 measurement in PM2.5. And we felt that was a 13 good indicator for tracking trends of lead in 14 rural areas and that would probably be 15 adequate to meet our rural needs. 16 Moving on to sampling and 17 analysis, we identified again the lead NAAQS 18 had not been reviewed in 30 some years and a 19 lot of our existing monitoring requirements 20 had some issues. Nonetheless, we did feel 21 that the monitoring methods that we had in 22 place were adequate, although they did have Page 31 1 some issues that we thought needed some 2 updating. 3 In addition, we identified that we

4 did not have an FRM for lead and PM10. And so 5 that was something that needed to be 6 addressed. And again, looking at the methods 7 the things that we identified is that we 8 needed for an improved sampler specifically to 9 pick up the ultra-course particles larger than 10 PM10 and that the existing FRM for TSP and the 11 FEM were quite out of date and needed some 12 updating. 13 Moving on to slide nine, this is 14 starting to talk about some of the revisions

15 we made to address these issues that we 16 identified. First off we required -- we 17 revised our network design requirements to 18 require source-oriented monitors at locations

19 of estimated maximum concentration. 20 We required them for sources other 21 than airports that were estimated to emit half 22 a ton or more of lead. Sites near sources, we Page 32 1 actually did this through two rulemakings, the

2 2008 review and the 2010 we made a revision to 3 our requirements. So our sites were actually, 4 went out in two phases. 5 Sites near sources emitting 6 greater than one ton were required to be 7 operational by January 1, 2010. Sites near 8 sources greater than a half a ton, but less 9 than a ton were required to be operational by 10 December 27, 2011. We did allow for waivers.

11 In this case states were allowed 12 to either do modeling or review existing 13 monitoring data to determine whether or not a 14 source was likely to cause concentrations to 15 exceed half of the NAAQS. If they were found 16 to be less -- to likely cause less than half 17 the NAAQS we were allowing waivers. 18 Approximately 230 sources were 19 identified in our national emission inventory 20 with emissions greater than a half a ton. 21 Those were reviewed and ultimately we ended up 22 with about 130 required source-oriented Page 33

1 monitors. 2 For airports we also required 3 monitoring for airports that are estimated to

4 emit one ton or more. We have identified four 5 airports that are likely to emit one ton or 6 more. And those were required to be 7 operational by January 1, 2010. 8 In addition we required non

9 source- oriented monitors at NCore sites in 10 core based statistical area, CBSA, with a 11 population of 500,000 or more. This resulted 12 in approximately 60 sites that were required 13 to be operational by December 27, 2011. And 14 the purpose of those monitors was primarily to 15 track trends of lead concentrations in general 16 populations, not necessarily the most impacted 17 populations. 18 Moving on to slide 10, we also 19 required a one year monitoring study at 15 20 specific airports emitting between half a ton 21 and one ton per year. Those airports were 22 specifically identified in the rule or in the202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 reg language. 2 Airports were selected based on 3 three criteria. Lead emissions greater than 4 a half a ton, ambient air within a 150 meters 5 of the runway end or the run up area, 6 meteorology and airport layout that led to a 7 majority of the take offs from one runway end. 8 And these sites were required to be 9 operational by December 27, 2011. 10 I do want to point out that we 11 found that there are some complications when 12 siting monitors near airports so there are a 13 few airports that are straggling, have not 14 quite bit in. There are actually several that

15 went out well in advance of the deadline. So 16 it's kind of a mixed bag there, but I did want 17 to point out that there are some laggards that 18 haven't quite got in but are still working to 19 get put in.

20 We did make some revisions to 21 allow for lead and PM10 sampling. We're 22 allowing that in all non source-oriented sites Page 35 1 and select source-oriented sites, those sites2 where we were not expecting to see ultra3 course lead, such things as fuel combustion 4 sources, things like that where we're not 5 expecting to see the more course lead. In 6 addition, any site that exceeds 75 percent of 7 the NAAQS. Yes.

8 DR. JOHNSON: I have a 9 clarification question. What does ambient air 10 within 150 meters of runway end mean? 11 MR. CAVENDER: Okay. So actually 12 I'm wondering if I could get Marion to answer 13 that question. She's our airport expert. So

14 we'll let her --

15 DR. HOYER: Ambient air in the 16 context of an airport is anywhere where the 17 general public could be. And airports aren't 18 like point sources where we have a fence line 19 necessarily, because we have a lot of pilots 20 in training as well as families who come to 21 airports. So ambient air can be within the 22 fence line of an airport. So we would Page 36 1 consider residences, roadways as well as 2 interior spaces in an airport where the 3 general public could be.

4 MR. CAVENDER: So for lead and PM10 5 sampling we did have a requirement in there 6 that if the concentrations exceeded 75 percent 7 of the NAAQS or more, that they would have to 8 switch to lead and TSP sampling. So basically 9 we're, we can find a nonattainment with the 10 lead and PM10 if it exceeds the NAAQS. But if 11 it's approaching the NAAQS we want them to 12 switch to lead and TSP so there won't be any 13 question about, you know, where are they in

14 this scale issue. 15 We promulgated a new FRM for lead

16 and PM10. That was based on a low volume 17 sampler with XRF analysis. And we made a 18 number of updates to our quality assurance 19 requirements. Again, this is a 30-year old 20 requirements in a lot of cases and there were, 21 a lot of updating needed to be done. 22 So moving on to 2,000, moving on Page 37 1 to slide 11, this is just a map of our 2 expected and current network. A bunch of

3 different dots on there with different 4 meanings. Kind of reddish looking dots are 5 the previously existing sites. So these are 6 sites that may have already been running plus 7 the new one ton per year sites that went out. 8 The blue squares, which I want to 9 point out are probably, are certainly overdone 10 are what were the potential new half ton 11 sites. So we again, we identified about 130 12 of these. It appears that only 30 of them 13 actually went in because of the waiver 14 process. 15 So those blue dots are probably

16 overdone and as the data comes in we'll be 17 able to update this map and get a better 18 reflection of where those are. The triangles 19 are the NCore sites, the urban NCore sites. 20 And then there's a green diamond. That's 21 where our 15 airport study sites are. 22 Moving on to slide 12, this map202-234-4433 Neal R. Gross & Co., Inc. Page 38

1 indicates where the nonattainment areas were

2 identified. There were two rounds of 3 designations that went through and ultimately 4 we came up with 21 nonattainment areas that 5 are currently identified based on the monitors

6 that were out. The 2010 monitors that went

7 out had several sites that were identified

8 based on those monitors. None of the old 2011 9 monitors would have been wrapped up into these 10 rounds of designations. And that is all I 11 had. So I'm going to switch to -- 12 DR. FREY: Maybe we just do a few 13 clarifications. I wanted to just confirm, you 14 had mentioned this for the airport sites that 15 some sites were not actually operational by 16 December 27th, but some were operational 17 earlier than that. And I just was curious on 18 the other sites where there was a required to 19 be operational by date, have those other 20 target dates been met? 21 MR. CAVENDER: In most cases, yes.

22 But also there will be some that that's not Page 39 1 the case, especially the 2011. I'm fairly 2 certain the 2010s are all in, but the 2011 I 3 know there are some that are still having some 4 issues getting sited and installed. 5 DR. FREY: Okay. And then for the 6 sites that are operational, is that data 7 adequately, I guess quality assured and

8 available and useful data?

9 MR. CAVENDER: The 2010 data will 10 not be certified until June. I'm looking at 11 my boss right behind you. I think it's June 12 of this year.

13 MR. WEINSTOCK: 2010 data was 14 certified May 1, 2011. 2011 data will be 15 certified this May 1st. 16 MR. CAVENDER: Okay. 17 DR. FREY: Okay, great, thank you. 18 And one other clarification, when you mention 19 that a site exceeding 75 percent of the NAAQS 20 is required to switch to the TSP monitoring, 21 are they allowed to retain the PM10 monitor

22 also? Page 40 1 MR. CAVENDER: Yes. Certainly 2 they would be allowed to keep that. 3 DR. FREY: Okay, great. 4 MR. CAVENDER: They would have to 5 add a TSP sample. 6 DR. FREY: Okay. And then I think

7 there were some other clarifications.

8 DR. CANFIELD: You mentioned that 9 you initially identified 230 sites I think and 10 only 100 and about 100 were allowed waivers. 11 MR. CAVENDER: Right, that's 12 right. 13 DR. CANFIELD: And so could you 14 say a little bit about the quality of the data 15 and/or modeling that went into determining 16 whether a waiver was granted. For example the 17 quality of the assumptions about emissions in 18 the models or the quality of the data that 19 were available for your determination. 20 MR. CAVENDER: They were required 21 to use the modeling requirements that are in 22 the various regs for TSP modeling and other Page 41 1 types of modeling. Those requirements are all 2 specified in the CFR. Our office, OAQPS was 3 not the lead on that. Our regions actually

4 handled most of that so I was not involved in 5 that. But they were to follow the 6 requirements for modeling. So however good 7 those requirements are, that's what they used. 8 DR. FREY: Okay. Anyone else? 9 Okay, thank you very much. 10 MR. VANDERPOOL: All right. Bob 11 Vanderpool, ORD. I'm an aerosol research 12 engineer. I've been asked to provide an 13 update on the EPA's activities directed 14 towards reviewing and revising the FRM for 15 lead NAAQS. 16 Most of my discussion today will 17 be and I think probably in the interest of the 18 panel, will be involved with the sampling side

19 of the FRM itself. There has been a fair 20 amount of activity associated with the 21 analytical side of the FRM itself. 22 So I want to start off my202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 presentation first by just talking about the 2 material I'll be covering. We'll be talking 3 about the FEM designations that have been made 4 the last two years by ORD. Joanne Rice of OAR 5 has also been very active the last year or two 6 in developing a new analytical FRM for lead

7 TSPs.

8 So I'll mention that and then 9 we'll talk about the lead sampling techniques 10 themselves. And I'll talk specifically about 11 the specifications for those sampling 12 methodologies, both lead in TSP and lead in

13 PM10. And also what the uncertainties that we 14 know we have regarding those two measurements.

15 And based on those uncertainties if we did 16 want to consider replacing or revising those 17 sampling methodologies how would we go about

18 it? 19 And again that's a large 20 discussion item, but we have started that 21 process in ORD. We have started some wind 22 tunnel tests and I would like to update you on Page 43 1 that activity and where we propose to go from

2 here. 3 We're on slide 15 to this point. 4 I won't spend a lot of time on this slide 5 because Kevin's already mentioned this to some 6 degree, but lead is a rather unique pollutant 7 because we have actually two separate sampling 8 methodologies for lead depending on the source 9 orientation, what we know about the

10 characteristics of the ambient aerosol that 11 we're sampling. 12 But we have two widely disparate 13 sampling methodologies. The Hi-Vol is a very 14 high flow rate. The sampler samples in a very 15 large filter. And we sample with a rather 16 inconventional AA analysis at least going back 17 almost 40 years now. On the other hand for

18 non source-oriented sites we have PM10 19 sampling that's used at a rather low flow 20 rate, much smaller filter and we have much 21 more sensitive analytical techniques that we 22 can deploy. Page 44 1 With regard to some of the 2 analytical changes that have been made to the 3 FRM in the last few years, ORD since 2010 has 4 reviewed and approved four new applications 5 for lead and TSP. This is, the first one was 6 submitted by Inter-Mountain Laboratory. The 7 other three were either sponsored by OAQPS or 8 Region 9. All of these involve ICP-MS 9 analysis with the exception of atomic 10 absorption spectroscopy, which was the very 11 last designation that was made last year. 12 We're also in the process now in 13 the very final stages of reviewing two new 14 applications sponsored by ERG. One for lead 15 in TSP and also we have our very first FEM 16 application for lead in PM10. This is based

17 on ICP-MS. So users of the lead in a PM10 18 sampler will now have the option of using 19 either XRF analysis, which is the FRM for the 20 lead in PM10 or using a wet chemical technique 21 for this particular method. 22 Both of these method applications Page 45

1 are in final review. And I think it's safe to 2 say that the designation decision on both of 3 these is imminent at this point. So we expect 4 in the next several weeks we'll actually be 5 publishing a notice in the federal register so

6 both of these methods are available for use.

7 I mentioned that Joanne Rice of 8 OAQPS the last year or so has been very active 9 in developing a new analytical method for lead 10 in TSP to replace the older existing flame 11 atomic absorption method. This method is 12 based on a couple different extraction 13 techniques, but it's mainly designed to 14 provide much higher detection limit 15 requirements provided by the new NAAQS 16 compared to flame atomic absorption. 17 And one feature of this particular 18 new FRM is it'll be applicable not only to 19 glass fiber filters, but course filters and

20 teflon filters as well. So that will be a

21 nice feature there. I understand from Joanne 22 that the round robin testing that's been202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 involved in this method development is in the 2 final stages.

3 She's received her results from 4 RTI, ERG, ORD and there's final results coming 5 in from ORIA. And so far those results, in 6 terms of precision and comparability look very 7 favorable. And she expects that this method 8 will be proposed either later this year or 9 possibly in 2013. All right. 10 Let's get to the sampling side of

11 the FRM and let's talk about what we know and

12 what the uncertainties of the various methods 13 are and how we might investigate revising the 14 sampling methodologies themselves. If we 15 start out going back to Appendix B in Part 50, 16 which provides the design specifications of 17 the sampler itself, what we find somewhat to 18 maybe some people's surprise is that the 19 specifications that are provided in Appendix 20 B are very limited in the design features.

21 If I'm a manufacturer of a Hi-Vol 22 TSP sampler for example, all I'm told is that Page 47 1 it has to have a gabled roof that's 2 rectangular in shape and that it has to 3 operate within a fairly wide range of flow 4 rates from 39 to 50 cfm. The inlet velocity, 5 the upward captured velocity of the sampler 6 can range anywhere between 20 centimeters a 7 second and 35 centimeters per second. Even 8 though 25 centimeters per second is 9 recommended, it's not required. 10 And it's interesting to go back 11 40, 50 years when the Hi-Vol was developed and 12 to actually track down the origin of this 25 13 centimeter per second recommendation. It 14 turns out that's exactly the settling velocity 15 of 100 micron particle. So the thought 16 process 40 years ago, in aerosol science, is 17 if you provide a sampler that has an upward 18 suction velocity of the same velocity as a 100 19 micron particle, you'll officially collapse 20 your 100 micron particles and everything less. 21 We know 40 years later that that's

22 not the case. It does not take into account Page 48 1 the high inertia of large particles moving in 2 a flowing airstream. And so as the result we 3 end up with a sampler that does not perform 4 the way it was initially intended. 5 I mentioned the last point of 6 timer accuracy of plus or minus 30 minutes. 7 I just for my own amusement actually just to 8 show how archaic some of the sampler 9 specifications that we're still dealing with 10 40 years later. But the main problem with the 11 specifications that are provided in Appendix 12 D, is that in general for ambient samplers the 13 performance, just to isolate their performance 14 of that sampler the efficiency with which it 15 can capture large particles is a function of

16 flow rate and its dimensions. 17 There are no dimensions provided 18 in Appendix B for the Hi-Vol sampler. And in 19 terms of flow rate we have a very wide range

20 between 39 and 60 cfm. Those are all user

21 selectable. 22 If we look at what we actually Page 49 1 know about the way the Hi-Vol performs and I 2 know you've seen some of these curves before 3 so I won't spend a whole lot of time on it. 4 But these go back again 40 years to the mid to 5 late 1970's. Dr. Wedding initially conducted

6 some of the wind tunnel tests of the Hi-Vol 7 sampler. And we need to conduct tests in the

8 wind tunnel because in the ambient air we 9 don't have control over wind speed or wind 10 direction or particle size.

11 So we conduct these tests under 12 controlled conditions using particles of known 13 aerodynamic diameter at controlled wind 14 speeds. He looked at the fact that the inlet 15 for the Hi-Vol was non symmetrical and so he 16 wondered what would be the effect of exposing 17 this sampler to particles in different

18 orientations.

19 And what he found is that the 20 orientation in which these particles approach 21 the sampler very much dictates the size 22 selected performance of that sampler. If you202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 look at particles that approach at 45 degrees, 2 that's approaching the corner of the sampler, 3 that achieves the highest sampling efficiency 4 of the sampler itself. 5 If we approach at any the other 6 angle at zero degrees as you see there in the 7 picture or at 90 degrees, which is from the 8 end, you get a much different performance from 9 the sampler. In fact if you look on the 10 bottom curve which represents either 0 or 90 11 degrees, the cut point of the sampler or the 12 sample or the particle size which is collected 13 with 50 percent efficiency is only 12 microns. 14 And again I think that's the kind 15 of thing that would be surprising to most 16 people to learn that the TSP sampler, which 17 stands for Total Suspended Particulate Matter, 18 doesn't sample everything. And it's very much

19 a function of the orientation with which the 20 wind approaches the sampler. Again, in the

21 ambient air we can't control the direction 22 with which particles approach the sampler. Page 51 1 By the way, these tests were only 2 conducted at one flow rate, 50 cfm and the 3 wind speed that was used during these wind 4 tunnel tests is only 14 kilometers an hour. 5 Normally we conduct these tests at 2, 8 and 24 6 kilometers an hour which corresponds to about 7 1, 5 and 15 miles per hour. So my expectation 8 just as an aerosol scientist, is that both of 9 these curves would probably shift to the lower 10 cut points at higher wind speeds than you see 11 even depicted here.

12 Dr. McFarland also conducted tests 13 of the same sampler at the same flow rate. He

14 understood that there were orientation issues 15 that Dr. Wedding had saw. So he put the 16 sampler on a turntable and he rotated it at 1 17 RPM during his tests. And what his interest 18 was is what is the performance of the sampler 19 as a function of wind speed. 20 And you can see from the three 21 curves at approximate wind velocities of 2, 8 22 and 24 kilometers an hour there's a very Page 52 1 dramatic reduction in size, selection and 2 efficiency as a function of wind speed. Again

3 we don't know what these curves would look

4 like at 39 cfm. We don't know what the curves

5 would look like at 60 cfm. These are all

6 uncertainties in the overall measurement of 7 what we're seeing. 8 So just to summarize what we've 9 seen, what we talked about and what we've 10 known for all these years and talked in 11 previous panel discussions, there's a wide 12 range of available flow rates for the sampler.

13 We have no dedicated test to look at the

14 function of those flow rates. We haven't done

15 a dedicated test to look at the function of

16 inlet velocities. There's no fixed inlet 17 dimensions on these samplers. 18 We've seen that there's very 19 strong wind speed dependence, wind direction 20 dependence. We also known there's a fair

21 amount of aerosol collection that can occur 22 during non sampling periods. And a sampler Page 53 1 such as this that has an eight by ten filter 2 doesn't lend itself to sequential multi event 3 sampling as would a smaller filter, such as 4 the lead in PM10 sampler. 5 On the other hand, if we look at 6 the lead in PM10 sampler and I was actually 7 involved in helping develop design 8 specifications for this back in 1987, we 9 actually looked at the specifications, the 10 design flaws if you will, the design 11 limitations in the Hi-Vol when we provided 12 these in Appendix L of the CFR.

13 Instead of the Hi-Vol which has no 14 design specifications we've got full design 15 specifications and 17 different drawings for 16 the dimensions, tolerances, materials and so 17 forth. The sampler operates at one fixed flow 18 rate. So just having fixed dimensions and 19 fixed flow rate means that all samplers 20 manufactured by all manufacturers perform 21 exactly the same way. 22 The inlet obviously is symmetrical202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 so that provides omni directional sampling so 2 we've eliminated wind direction independence.

3 We minimized rain and insect intrusion which 4 is important. And the most important thing is 5 that this inlet has been tested by more 6 researchers in more wind tunnels over a longer 7 time period than any other inlet that I'm

8 aware of. 9 So if you look at some of the test

10 results from McFarland and RTI and EPA over a 11 20-year time period, we see that the sampling 12 cut point from all these researchers 13 independent of wind speed is about 10 microns.

14 So if we look at the limitations of the Hi-Vol 15 and if we look at the key features of the lead 16 in TSP sampler which seemed to be favorable 17 and we want to combine these together, what

18 would those features be? What would those 19 design features be that we'd be interested in? 20 Well obviously we need to provide 21 very strict inlet dimensions. We need to 22 provide a constant flow rate. We need to have Page 55

1 an omni directional inlet. We need to have a 2 reasonable, acceptable variation in 3 performance as a function of wind speed over 4 the 2 to 24 kilometer an hour size range. 5 Thinking about the size select of 6 the performance of the sampler and thinking 7 about all these features and what our upper 8 limitations might be just due to particle 9 physics. Probably an upper cut point of a new 10 sampler would be on the order of 18 to 20

11 microns.

12 This is the size that's been 13 mentioned in previous panel meetings as 14 possibly achievable. An 18 to 20 micron cut 15 point would obviously measure all the 16 particles currently sampled by the lead in 17 PM10 sampler, plus a portion of those much 18 larger than 10 microns.

19 And then same with the low to 20 medium flow rate also gives us the advantage 21 of working with smaller filters, multi event 22 sequential designs and so forth. And then Page 56

1 based on the fact that we have fixed 2 dimensions and fixed flow rates, we expect to 3 have very strong both inter manufacturer and 4 intra manufacturer sampler performance. 5 So in terms of our developmental 6 approach at this point, what we would do again

7 within ORD is to conduct wind tunnel tests of 8 involving development of generation transport 9 measurement of very large particles. We'd 10 optimize our aerosol test facility wind tunnel 11 for these three wind speeds. And then we'd 12 really as a validation step, we'd actually go 13 back and retest the PM10 sampler itself and 14 make sure that our new generation in 15 measurement techniques are valid before moving 16 on to new prototype inlets.

17 Some of the inlets that have been 18 discussed before are actually commercially 19 available. This is one manufactured by URG. 20 This is something that Dr. Hopke mentioned 21 last year as a possible alternative. There 22 are a number of these commercially available Page 57 1 so we'll take a survey of those and we'll 2 conduct potentially a limited validation of 3 the way these perform. And then as necessary 4 we'll develop any new prototype samplers that 5 will hopefully provide a cut point in the size 6 range that we discussed. 7 I won't spend a lot of time on the 8 remaining slides. This is more show and tell 9 then anything else. But we do have access at 10 EPA to the world's largest aerosol wind 11 tunnel, very large dimensions, very easy to 12 move around in. There's very few blockage 13 issues to work with. And so again, we're very

14 fortunate to have this available to us. 15 Most of our previous size 16 selective tests in the past for the PM10 inlet 17 have been conducted using monodisperse 18 aerosols. These tend to provide very high 19 quality results, but it's very time consuming, 20 very labor intensive, difficult especially 21 when you're developing a prototype saying for 22 when you do a test and then you change flow202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 rate or you change inlet dimensions for 2 example. 3 And so it's easier if you can 4 develop the use of polydisperse aerosols in

5 the wind tunnels. So our current and it seems 6 right now in the wind tunnel or to use a bulk 7 polydisperse materials either Arizona Test 8 Dust or glass beads and then quantify these 9 materials in the test section using a Coulter 10 counter which analyzes particles as a function 11 of particle size over a wide range of sizes. 12 This is our current set up in the 13 wind tunnel. The photograph on the left is 14 our dust dispenser which disperses our bulk 15 material. We typically work in five and ten 16 pounds of this. That's one of the 17 disadvantages of having the world's largest 18 aerosol wind tunnel if you need to introduce

19 an awful lot of aerosol into the tunnel in 20 order to get to your detection limits. 21 But we deglomerate this bulk 22 material into individual sized particles using Page 59 1 a two stage sonic nozzle. And then we charge 2 neutralize those generator particles using the 3 two stage ion nozzle. The center photograph 4 shows the generation apparatus actually

5 mounted in the wind tunnel on a movable 6 travois so we can actually move these to

7 different locations as needed. And then the 8 photograph on the right is some of the 9 reference nozzles very low Stokes numbers that 10 we've developed for these tests.

11 I mentioned that there are a 12 number of commercially available low volume 13 inlets that are out there. These are designed 14 and operated anywhere to 5 to 16.7 liters per 15 minute and again I got the URD 1 in my hand 16 here just to give you an idea of the physical 17 scale that we're working on.

18 All of these low volume inlets 19 have a couple of features in common. One of 20 these is that they all claim to sample TSP 21 simply by virtue of the fact that they do not

22 have an internal fractionator. The other Page 60 1 feature is that none of these commercially

2 available units have been tested in wind 3 tunnels to any real degree.

4 So it's our intention to test not 5 all of these at all wind speeds for all 6 particle sizes, but just test enough of them 7 so we can gain at least a qualitative 8 understanding of how they may work as a 9 function of size. My personal expectation 10 based on experience is that some of these are 11 not going to provide a large enough particle

12 size collection characteristic. Some of these 13 may actually provide a couple in less than 10

14 microns. 15 Probably what we'll have to do is 16 go to sampler geometries closer to our 17 existing 16.7 Lpm inlet. The unit in the

18 middle has the internal fractionator which 19 provides a 10 micron cut point. The sampler 20 on the right has those components moved. So 21 we call this a "total sampler." So this is 22 probably where we're going to start for our Page 61 1 methods development is start off with a 2 sampler that we know has some degree of wind 3 speed independence and then go from there. 4 So my final slide is just to 5 provide a status of those research activities. 6 I've mentioned that we're in the progress now 7 of developing new generation techniques for 8 the polydisperse aerosol use, new measurement 9 techniques for the polydisperse aerosol use. 10 And then we'll be looking at a survey of these 11 low volume TSP inlets. We'll be conducting an 12 evaluation of the PM10 sampler itself and then 13 as needed will be designing new prototype 14 inlets to provide cut points closer to the 18 15 to 20 micron size range. 16 Once we have that, we'll obviously 17 be providing that information to you. There 18 may be one inlet. There may be a couple of 19 inlets that may be valuable candidates. And 20 certainly at some point once we have a final 21 design we'll want to go into the field that's 22 selected either source-oriented, non source-202-234-4433 Neal R. Gross & Co., Inc. Page 62

1 oriented sites to measure the inherent 2 precision of these new candidate FRM's and 3 also measure comparability with existing TSP 4 samplers and existing TSP samplers. 5 So that concludes my presentation. 6 I'd be happy to listen to any comments you may 7 have at this point. 8 DR. FREY: Yes. Dr. Hopke. 9 DR. HOPKE: So you're headed at 10 once again to a design standard rather than a 11 performance standard? 12 MR. VANDERPOOL: The design

13 standard would be such that it would have

14 fixed dimensions and fixed flow rates so that 15 we understand how it performs in the field. 16 Remember when we deploy and operate a sampler

17 in the field we won't have control over wind 18 speed, wind direction and particle size. 19 So yes it would be more of a 20 design standard in terms of the inlet 21 dimensions, the inlet flow rate and then we 22 would allow the manufacturers to provide that Page 63 1 flow rate using whatever technique that they -

2 - 3 DR. HOPKE: So you assume 4 manufacturers can't come up with clever 5 designs and meet a performance standard. 6 You're making the same mistake over and over. 7 MR. VANDERPOOL: The problem with 8 allowing the manufacturers to develop 9 performance data for the inlets is that they

10 don't have access to aerosol wind tunnels that 11 are necessary to evaluate the size selective 12 performance. We barely have access to our own 13 wind tunnel at this point. So yes, it would 14 be a design standard to eliminate the

15 uncertainties associated with different 16 designs. 17 DR. FREY: Yes. George go ahead

18 and then --

19 MR. ALLEN: This is a little 20 tight. All right. Bob, thank you. I want to 21 commend the EPA for finally taking on this 22 task. It's not easy. It's a lot of resources Page 64

1 in a time when resources are constrained. 2 On the other hand I think as you 3 made some really good points, the status of 4 the existing FRM sampler is, perhaps could 5 best be stated as embarrassing given that 6 we're in the 21st century. And it is indeed 7 well past time to overhaul it with current 8 technologies and aerosol science knowledge 9 that we now have as you've pointed out. 10 We've both been around long enough 11 to remember back in the late 70's and early 12 80's when we were half blind to this process. 13 But things were even worse back in the 50's or 14 late 40's, 50's when the Hi-Vol was developed. 15 And I acknowledge that what you're trying to 16 do is very difficult. 17 I mean the reality is we can't do 18 what we might want to do. So then the 19 question is are we okay with doing the best we 20 can do, which would be better than the current 21 FRM but perhaps not, maybe not and that's 22 something I'd like to get back to later today, Page 65 1 maybe not as much as the panel from the health 2 exposure end of things might want. We can't 3 really do a true TSP sampler unless there's 4 almost no wind speed. 5 One question I do have is given 6 the path forward you've outlined and given 7 where we are in the NAAQS review process, do 8 you see getting something that a new FRM 9 sampler could be promulgated in this review or

10 would that have to wait until the next one? 11 And of course I don't think we can promulgate 12 a new FRM sampler for lead that is not in the 13 context of a NAAQS review because it might 14 actually have some impact on the value or 15 level of the NAAQS if you're sampling a

16 different amount of lead in the air?

17 MR. VANDERPOOL: Well what I would 18 say is obviously if we were going to replace 19 the lead in TSP sampler with something else we 20 have to it for the right reasons in the right 21 way. So we have I think an idea of what needs

22 to be done in the wind tunnel in order to202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 characterize, to develop and characterize new 2 and better samplers. 3 We've got roughly about a year, in 4 terms of timetable we've got roughly about a 5 year of additional funding to conduct these 6 tests. I did mention that we'll certainly

7 have to conduct some level of field validation

8 of a source-oriented and non source-oriented

9 sites after that. 10 And certainly if we develop a new 11 sampling methodology there's going to have to

12 be some consideration whether the level of the 13 standard, the .15 micrograms per cubic meter,

14 needs to be revised or retained based on what 15 we know in terms of what that sampler collects 16 or does not collect. And those types of 17 discussions are going to take some interaction 18 between EPA and the panel and the other

19 stakeholders. 20 So to give you a short answer to 21 your question, I would think it's probably 22 unlikely that all that could occur in time to Page 67 1 get this promulgated during the current review 2 cycle. The main thing is that we've opened 3 the issue up for continued discussion. We're 4 addressing the issues and we do plan on moving 5 forward on the research necessary to address

6 the issues.

7 DR. FREY: Thanks. Just to 8 clarify and then Dr. Rabinowitz and then Rich 9 Poirot. I'm not trying to pin you down on a

10 schedule but --

11 MR. VANDERPOOL: Go ahead. 12 DR. FREY: -- what, I think if I 13 understand what you just said is the first 14 bullets there except the last one are part of 15 the scope that you're describing in the next 16 year and then that last bullet would be 17 subsequent. Is that a correct interpretation?

18 MR. VANDERPOOL: Yes. I did fail

19 to mention in terms of the status on this 20 particular site that the new analytical FRM

21 for lead in TSP has been drafted. It will be 22 proposed during this review cycle either this Page 68 1 year or next year. And I think it would be 2 safe to say that it could certainly be 3 incorporated into this review cycle. 4 The revisions, the possible 5 revisions to the sampling side of revising the 6 lead FRM, again we'll do the very best we can 7 with the resources we have during this review 8 cycle. But it certainly may not get done in 9 time to propose and promulgate it by the end

10 of 2014. 11 DR. FREY: Okay. Thank you. Dr.

12 Rabinowitz. 13 DR. RABINOWITZ: Firstly, thank 14 you for a clear presentation. And for me I 15 have this take away message from it and help 16 me try and get this right. It looks like 17 historically if you look at the TSP data that

18 was collected back in the 90's for instance or 19 the 80's, we didn't know it but the T was not 20 really total. 21 We were missing 20, 30 who knows 22 what sum percentage. So if you go back and Page 69 1 look at the old airborne lead data we may have 2 inadvertently been underestimating it by some 3 unknown percentage. We're probably within a 4 factor of two, but we're not that exact, as 5 exact as you might have thought. 6 MR. VANDERPOOL: No, I think 7 that's a very accurate statement. And the 8 bias, if you will, in terms of what we're 9 measuring and what the total concentration 10 that's out there is unknown during any given 11 sampler events, because we don't know wind

12 direction. 13 We don't know wind speed and we

14 don't know the size distribution of lead 15 bearing particles during that sampling event. 16 So we don't actually know with any degree of 17 confidence what it is we're measuring. I 18 think your take is exactly correct. 19 MR. POIROT: Bob, I wanted to ask 20 if you had -- 21 DR. FREY: You're not done yet. 22 MR. POIROT: -- assuming you could202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 achieve this 50 percent cut point up in the 2 range of 18 or 20 microns, couldn't that 3 presumably collect more PM10 particles than

4 the Hi-Vol under certain wind conditions?

5 MR. VANDERPOOL: More PM10 6 particles? 7 MR. POIROT: That is under the, 8 yes, more PM10 particles than the TSP sample -

9 - 10 MR. VANDERPOOL: I wouldn't expect 11 it to necessarily collect more PM10 particles. 12 MR. POIROT: Well particles in the 13 10 micron size range. 14 MR. VANDERPOOL: There may 15 actually be circumstances if you had a sampler 16 that had a 20 micron cut point that was 17 independent of wind speed and wind direction, 18 it actually may collect more lead mass than 19 would a co-located Hi-Vol TSP sampler just 20 because of the sampling biases that we've 21 discussed this morning. 22 MR. POIROT: The second question Page 71 1 was presumably this cut point wouldn't be real 2 sharp, would it? 3 MR. VANDERPOOL: Well again, 4 that's the type of thing that's up for 5 discussion. Do we want a sharp fractionation 6 curve? You know, one of the logistical 7 realities of working with large particles is 8 that the higher you go in particle size the 9 more uncertainty you have in generating 10 transport and measuring those particle sizes. 11 So my expectation is when we get 12 it in the wind tunnel and ask me a year from 13 now where we are, but in this investigation 14 we're probably going to have more variation in 15 sampler performance as a function of wind 16 speed than we do with the current PM10 inlet 17 for example. But that may be totally 18 acceptable based on those goals. 19 MR. POIROT: I guess, you know, 20 and then the third question maybe is more for 21 Kevin but, what about the idea of having some 22 additional particle size information in the Page 72 1 ambient air around these large sources and 2 that sort of thing as a way to help determine 3 okay what's the particle size that we want? 4 MR. KAVENDER: Yes. Actually that 5 kind of might go back to Bob again. Bob and 6 I and Jen worked on a paper a while back to 7 try to gather as much information from the

8 literature that we could on the size 9 distribution around, just basically size

10 distribution of lead in all different 11 settings, including source-oriented sitings.

12 We didn't find a lot of data. I 13 think that was ultimately the conclusion is

14 there wasn't a lot of data. And what we did 15 find varied greatly making it difficult to 16 make conclusions. I think that was something 17 Bob was actually thinking of when he does roll 18 out that he might be working with some other 19 samplers that might give us some better size 20 distribution as we're doing the field 21 evaluations so that we can get some

22 information on size distribution. Page 73

1 And exactly like you're saying it 2 is possible that a PM20 cut point may give us 3 higher concentrations than a TSP sampler 4 because we're getting better collection 5 efficiency between 10 and 20 than the current 6 TSP sampler. So, yes that's something that 7 again we've looked at the literature. We 8 didn't find much and it may be something that

9 we need to collect more of. 10 We did also do PM10 and TSP through 11 our last review. There was a little bit, 12 maybe more of that data, but that doesn't 13 really give us the full distribution 14 information that we would really like to look

15 at.

16 DR. FREY: We have a few more -- 17 Claire, I think we're starting to get pressed 18 for time. So I know there are some of you who 19 have clarifying questions and if we can keep

20 them brief. And I saw Dr. Davidson and Dr. 21 Canfield and George Allen. So go ahead. 22 DR. DAVIDSON: Okay. Thanks very202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 much, Bob. I think that it's really great to 2 hear that you're stepping out into an area 3 that's likely to make a change in this problem 4 that obviously we've all been aware of for

5 decades. 6 But I'm wondering if in fact the 7 idea here is to try and get a handle on all of 8 the lead in the air, including the very large 9 particles that are hard to sample from the 10 air, has there been any thought given to 11 looking at a deposition standard where the 12 material that you collect on an 13 aerodynamically designed flat surface can give 14 you a representative and repeatable sampling 15 of large lead particles that are probably 16 coming out of the air by sedimentation and 17 other deposition mechanisms?

18 MR. VANDERPOOL: The short answer 19 is no there hasn't been a lot of thought given 20 towards that direction. Again, we're dealing 21 with a national air ambient quality standard. 22 We certainly want to protect against the Page 75

1 particle size that we know penetrate to the 2 lower respiratory tract. 3 Those particles are going to have 4 a greater effect on blood lead concentrations 5 than say a 50 micron particle which may never 6 actually enter the respiratory system. And so 7 a deposition sampler may not actually 8 representatively collect the sub 10 micron 9 size fraction. So it's a difficult pollutant 10 from the beginning in that we have multiple 11 roots of exposure from multiple size particles 12 and we have multiple results in terms of blood 13 lead depending on what those roots of exposure

14 are. 15 So it's not an easy thing to 16 approach with a single sampler. My 17 recommendation is that we develop an ambient 18 air sampler that cuts as I say in this 20 19 micron size range. And then if we want to 20 understand deposition around source-oriented 21 sites, special studies can be, I mean you 22 almost need a soil sampler of special studies Page 76 1 using deposition samplers and that sort of 2 thing can used to augment our understanding of 3 what the aerosol concentration may be in the

4 ambient air. 5 DR. CANFIELD: I'll just be quick 6 with a couple of questions. One is to what

7 extent are the data that were used to allow 8 waivers for certain sites based on the high 9 volume TSP sampler? And well you can answer

10 that. 11 MR. KAVENDER: I'm sorry. Could 12 you repeat it again? I was thinking it was 13 going to Bob and I was zoning out.

14 DR. CANFIELD: So to what extent 15 when waivers are, maybe you don't know this as 16 well, but when waivers for sites are granted,

17 to what extent are those waivers based on data 18 from the high volume TSP? 19 MR. KAVENDER: So there's multiple 20 options that are allowed. Historical 21 monitoring data, which was very rare, 22 basically there wasn't monitoring data for Page 77 1 them to use. That may happen more in the 2 future as we've required these monitors to go 3 out after they've collected three years of 4 data they might be able to get a waiver 5 through that three years of data.

6 So most of the waivers that were 7 granted, almost all of them would have been 8 based off of modeling information. And those

9 emission estimates would have included all 10 particle sizes. It wouldn't have been 11 fractionated. Does that answer the question,

12 somewhat? 13 DR. CANFIELD: Are you concerned 14 about it? Maybe that's a better, about the 15 role of TSP sampling and the granting of

16 waivers?

17 MR. KAVENDER: Under the current 18 standard, no. And I think you'd asked 19 earlier, I did want to point out one other 20 thing. When I mentioned that there's waivers, 21 I'm not sure it was in my slide, but we did 22 only allow waivers for up to 50 percent of the202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 NAAQS. We factored in that there was going to 2 be some uncertainty. So we didn't allow 3 waivers all the way up to just under the 4 NAAQS. So we took into account some 5 uncertainty with modeling and other estimates. 6 DR. CANFIELD: Okay. I guess this 7 would be for Bob. The relative importance of 8 new analytic techniques versus the new 9 sampler, do you think the new analytic 10 technique is going to make a sizeable 11 difference in our measurements in, or our 12 accuracy as comparison to the continued

13 reliance on -- 14 MR. VANDERPOOL: No, I mean 15 obviously we're much further along in the 16 analytical development than we are in the 17 sampler development. So, you know, if we 18 developed a sampler for example that cut at 20 19 microns we would propose either XRF or ICPMS

20 or both as a federal reference method. So 21 we'd be in excellent shape for doing efficient 22 extraction and analysis on whatever samples Page 79 1 were collected by the new sampler. 2 DR. FREY: Okay, George quick 3 question. 4 MR. ALLEN: More really a point of 5 clarification for those on the panel who are

6 not in the aerosol science business. I would 7 think it's very possible to have a scenario

8 where the current louvered inlet with no size 9 cut, which is what we're talking about for the 10 most part, would certainly sample more lead in 11 a windy, dusty environment at higher wind 12 speeds under certain circumstances, certain 13 wind directions and speeds than would the 14 existing Hi-Vol FRM. Is that a fair 15 statement? We certainly could have scenarios

16 like that.

17 MR. KAVENDER: I don't have that 18 answer until we actually get in the wind 19 tunnel with that particular inlet. As you 20 know, George, Lee Kenny had done some wind

21 tunnel evaluation of the louvered inlet to 22 look at the aspiration characteristics of Page 80

1 itself. 2 Unfortunately her tests were 3 limited to very low wind speeds so we don't 4 have an understanding of how that sampler may 5 aspirate large particles at 24 kilometers an 6 hour. But that's certainly something we fully 7 intend to do and we'll update you at a later

8 date. 9 MR. ALLEN: Okay. Thanks. 10 DR. FREY: Okay. Well Mr. 11 Kavender and Dr. Vanderpool, thank you very 12 much. Obviously you generated a lot of

13 interest. And we'll now move onto a 14 presentation by Dr. Marion Hoyer on lead 15 emissions from piston aircraft. 16 DR. HOYER: Okay. We are on slide 17 32. I'm from our Office of Transportation and 18 Air Quality which is a sister office to the 19 Office of Air Quality Planning and Standards 20 in OAR. And our office is responsible for 21 regulating emissions from mobile sources. 22 So I wanted to tell you about our Page 81 1 work evaluating emissions from piston engine 2 aircraft that operate on leaded fuel. We have 3 an ANPR, an advance notice of proposed 4 rulemaking, out in the FR. It was published 5 in April of 2010, where we summarized

6 available data that we had on this issue. And 7 I will talk just a bit about that and what 8 we're doing as follow on work. 9 We issued this ANPR in response to 10 a 2006 petition from the environmental group, 11 Friends of the Earth, who asked us to conduct 12 two different lines of investigation. One is 13 to evaluate the potential for endangerment to 14 public health and welfare given the existing 15 information. Or if information was inadequate

16 to initiate studies in order to understand the 17 answer to this question of endangerment. 18 So the ANPR, I'm on to the next 19 slide, here we go, was intended to get 20 information out in the public purview and ask 21 a series of questions, because in fact there 22 are very few studies available that summarize202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 either exposure, emissions information or 2 blood lead concentrations, at least there were 3 no data at that time in the public literature. 4 So we asked a series of questions in this ANPR 5 trying to solicit information in case we 6 hadn't found anything that was out in the 7 public.

8 So in addition to that we also 9 summarized the work that we'll be doing next,

10 which I'll mention on the next slide. But we 11 did not receive any information from the 12 public of which we weren't already aware. And

13 some of those studies are summarized in the 14 ISA, but those that aren't in the public, 15 haven't been peer reviewed aren't found in the

16 ISA. 17 So onto our next steps in what we 18 are engaged in now and the timing which I 19 think is probably what you're most interested 20 in. We are looking at the demographic data 21 for people, specifically children who live 22 near these airports. As you're aware from Page 83 1 reading the ISA there are 20,000 airports in 2 the country where these piston engine aircraft 3 operate. 4 And so we're looking at the number 5 of children who live near those airports with

6 the 2010 census data. Those data will be 7 available to you in the policy assessment that 8 you'll see this fall. We're also modeling 9 piston engine aircraft emissions and we've 10 already conducted one model evaluation study 11 which is summarized in the ISA that you have

12 now. 13 And we're moving onto model other 14 airports so that we can understand different 15 airport attributes and the gradients in 16 concentrations near airports. We expect to

17 have the results of those data at the end of 18 next year or early 2014. And then in addition 19 to that, as you already know from Kevin, we 20 have new monitoring rules that are requiring 21 monitoring near 15 general aviation airports 22 and those data we expect to have certified by Page 84 1 the end of 2013, by the end of next year. 2 Those aren't all fully implemented yet. 3 So that's what our timing is 4 looking like and the broad outlines of what 5 we're doing. I'm happy to answer any specific 6 questions you have about this source sector. 7 DR. FREY: Yes. Rich, go ahead. 8 MR. POIROT: I was just wondering 9 if you had any information on the day of week 10 patterns or seasonal patterns in the use of 11 those things that might be related back to

12 ambient measurements?

13 DR. HOYER: We do in terms of 14 activity. There are 3,500 airports that FAA 15 considers important for national 16 transportation and at a subset of 17 approximately 600 of those facilities FAA 18 collects daily operations data. 19 It's not subsetted out by jet 20 engine operations and jet fuel does not 21 contain lead, versus piston engine operations. 22 So we have to estimate the fraction of piston Page 85 1 activity. But it depends on the type of 2 airport. If it's an airport that is serviced 3 mainly by planes for summer time vacationing 4 then it does have a strong seasonal variation. 5 Some airports are reliever 6 airports so they have a more consistent annual 7 and weekly cycle. Some airports mainly 8 facilitate training activities. So those tend 9 to have a higher weekend activity. So it

10 varies. Yes.

11 DR. MICHAEL KOSNETT: I could be 12 incorrect, this is Michael Kosnett, but is it

13 true that there's an aviation fuel that's 14 manufactured in Sweden for non, you know for 15 piston aircraft that doesn't contain lead?

16 DR. HOYER: Yes.

17 DR. MICHAEL KOSNETT: And it's 18 trying to be sold in the United States. I'm 19 just wondering if your monitoring in any way 20 can discern the impact of the airports or 21 conditions when there's a higher prevalence of

22 the use of the non-leaded aviation fuel202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 compared to the leaded aviation fuel?

2 You see this is what I'm 3 concerned, the big picture I'm concerned about 4 is supposing you go out there and monitor and 5 you don't at a particular airport or a 6 particular time and you don't find much lead. 7 But it could turn out that at the airport you 8 were monitoring or the time that you were 9 doing the monitoring the planes that were10 taking off and flying were using the non11 leaded aviation fuel. 12 And then, but without knowing that 13 you would say well we checked around airports

14 and there's not an issue. But there's not an 15 issue because of the time you looked they 16 weren't using the leaded fuel. So you follow 17 my point?

18 DR. HOYER: Yes. Unleaded fuels 19 are not widely available in this country. And 20 the 15 airports where we have monitoring are 21 keeping in touch with those facilities. Some 22 have tried to look into providing unleaded Page 87 1 fuel, but it has not yet proven out. So all 2 the information we have suggests that all of 3 these airports are currently operating their 4 piston engine aircraft on leaded fuel. 5 There are a lot of very 6 complicated issues involved in delivering an 7 unleaded fuel, aircraft being certified to run 8 on unleaded fuel for safety. And so it's not 9 widely available. And if folks are using it 10 they are generally bringing it in in a tank in

11 the back of their truck. 12 DR. MICHAEL KOSNETT: And do they 13 use non-leaded fuel in Sweden widely? 14 DR. HOYER: They do. It's my 15 understanding, we're not heavily engaged in 16 Europe with, you know, solutions to this

17 issue. 18 DR. MICHAEL KOSNETT: I'm sorry. 19 DR. HOYER: We're not heavily 20 engaged with the Europeans right now on 21 solutions to that part of the issue because 22 we're very focused on the endangerment Page 88 1 question itself and what are the exposures. 2 DR. MICHAEL KOSNETT: So I'm just 3 wondering though if to basically sort out this 4 issue about the contribution of leaded fuel, 5 if you have situations in Sweden where you6 have commercial aviation that's using non7 leaded fuel and they have data on the 8 measurements that they're obtaining near their 9 airports, would it not be helpful to obtain 10 that data and compare it to the measurements 11 you have so that you could potentially learn 12 something about the comparison?

13 DR. HOYER: Yes. We do. We are

14 in touch with folks there who have done some 15 emissions testing on these piston engine 16 aircraft. To our knowledge they have 17 conducted no monitoring of lead near these 18 airports. And again this is outside the 19 commercial aircraft realm. So it really is 20 this, what we call, general aviation sector 21 which is typically a different kind of 22 airport. Page 89

1 You have to be, right, so but I 2 did want to come back to your point about 3 potentially missing the lead. And the 4 placement of a monitor at an airport is really 5 the key to picking up the signal from the 6 plume of these aircraft because of their 7 operations around the facility.

8 The run off emission that Kevin 9 was mentioning happens at a discreet location 10 at the end of the runway and it is the most 11 fuel consuming mode of operation for the

12 aircraft. And of course aircraft take off 13 into the wind so that plume is being 14 transported downwind from that location and

15 that's where the monitor needs to be. You could 16 very easily have a monitor within a few meters 17 of a runway that if it's upwind of the runway 18 or next to it, you're going to miss the high, 19 you could get sampling upwind there. 20 DR. FREY: Just maybe a follow up 21 to clarify. So in monitoring these 15 22 airports would there be also a collection of202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 activity data related to the fueling of 2 aircraft? And would you have knowledge of the

3 source or the content of lead in the fuel used 4 at that airport?

5 DR. HOYER: Yes. We are 6 attempting to collect fuel and analyze it for

7 lead. We have done that at a few of these 8 airports already. We hear from industry that 9 there is potentially a seasonal variation in

10 the lead concentration. So it's kind of 11 difficult to get, you know, an absolute number 12 that's relevant to all of the flights. Plus 13 they come in with a tank, they obviously don't

14 -- 15 DR. FREY: Right, they may not 16 refuel at that airport. 17 DR. HOYER: Right. Exactly. 18 DR. FREY: Okay. Dr. Rabinowitz. 19 DR. RABINOWITZ: Well thank you. 20 About the tetraethyl lead that's added to the 21 gasoline as an octane booster, is it made in 22 the United States? I'm thinking like as an Page 91 1 isotope geochemist for a second and I'm 2 wondering if it's made in the United States 3 where they get the lead from. Or is it 4 imported as tetraethyl lead? 5 DR. HOYER: It's imported. 6 DR. RABINOWITZ: Do you know where 7 it's imported from?

8 DR. HOYER: Well there are new 9 places coming online manufacturing it is what 10 we're being told in China.

11 DR. RABINOWITZ: The reason I'm

12 almost a little excited about this is that if 13 suddenly a new source of lead appears in the 14 industrial flow it would isotopically perhaps 15 stand out. For instance, if they started 16 using Broken Hill lead to add it as a fuel 17 additive in place of maybe some other lead 18 they used before you should be able to trace 19 this lead. It should be very distinctive, if 20 you get lucky. 21 DR. HOYER: Right. 22 DR. RABINOWITZ: So do we have any Page 92

1 idea where --

2 DR. HOYER: Well we're told it 3 could be coming from at least three locations 4 in the world right now. I don't think anyone 5 really has the answer to that, but because 6 again we're focused so specifically on this 7 part of the issue and not the control aspect 8 yet that we haven't tried to chase that

9 back. DR. RABINOWITZ: On a 10 separate note, you'd just be measuring lead 11 you're not going to look for health effects.

12 DR. HOYER: Correct. Yes. 13 DR. RABINOWITZ: My concern of 14 course is that when you're by an airport 15 you're exposed to more than just lead.

16 There's noise and there's been a lot of 17 studies with school performance near airports 18 and a lot of issues. Okay. Thank you. 19 DR. FREY: Okay. Any other 20 clarifying questions? Okay. Well thank you, 21 Dr. Hoyer. Our next presentation is from the

22 National Center for Environmental Assessment Page 93 1 and our presenters are here. I see Dr. John 2 Vandenberg and, okay the floor is yours. 3 DR. VANDENBERG: Okay. Thank you 4 very much. My name is John Vandenberg and I'd 5 like to also extend my appreciation to the 6 panel, to the SAB staff and to the visitors 7 including my staff here that have been very 8 involved in the development of the second 9 draft, first and second draft of the ISA.

10 I'm the Director of the Research 11 Triangle Park Division of the National Center 12 for Environmental Assessment and I'm joined 13 here today by Dr. Ellen Kirrane. Ellen is the 14 team leader for our lead group and much of the 15 lead group is sitting to the back there. So 16 we're very pleased today to have this 17 opportunity to get your input on our second

18 draft.

19 So what I'd like to do is as I

20 mentioned in addition to the EPA staff I would

21 also like to note the external authors that we 22 have engaged to help us as we've developed the202-234-4433 Neal R. Gross & Co., Inc. Page 94

1 first and second draft of the ISA. And 2 they're listed here on the second sheet. As 3 Lydia mentioned earlier, the time line is such 4 that we're today reviewing the second draft 5 and our anticipation is to receive your final 6 written comments and report from the committee

7 to take that into consideration.

8 We have reviewed the draft 9 materials that were provided in advance and 10 very much appreciate the thoughtful comments

11 that we have received. I think it's been our 12 experience that we always benefit from the 13 comments and the range of expertise 14 represented by the group here is certainly 15 very helpful to us. And as you see here our 16 target is to finish the final ISA up later

17 this summer. 18 What I'd like to do is just do a 19 quick highlight of a couple of the major 20 changes to the ISA and they're going to be 21 shown by myself and then by Dr. Kirrane in red 22 with some highlighting of things that are the Page 95 1 focus of the charge to the panel today. In 2 particular, we have found that as we've 3 developed the different integrated science

4 assessments for the various criteria air 5 pollutants, that we have continued to evolve 6 our approach to improve the communication of 7 the material, the essence of it. 8 And in the second draft as you've 9 seen we have now incorporated a new preamble, 10 preface and executive summary. This stems

11 from work that was done on our ozone 12 integrated science assessment where we found 13 that as the reviewers have commented, there's 14 a lot of complexity to these assessments and 15 yet some of the material is consistent across

16 the different ISA's. 17 And so by bringing that into a 18 preamble in terms of the context, the setting, 19 the history, the preamble and the preface, we 20 can show that consistency across the 21 integrated science assessments and then really 22 use the executive summary to focus on the Page 96 1 particulars of this review, in this case of

2 lead.

3 So we have restructured this to 4 try to improve that communication and 5 certainly welcome your views on that, which is 6 one of the charge questions. The rest of the 7 Chapters 2 through 7 have been revised again 8 considering the comments that we received from 9 the panel as well as from the public on the

10 first draft. 11 And we're just going to very 12 briefly review the charge questions and some 13 of the essence of what we have changed in our

14 second draft. So let me turn this to Ellen 15 Kirrane to run through that. 16 DR. KIRRANE: Thank you. So 17 beginning with Chapters 1 and 2, the summary 18 chapters, we're requesting comments and 19 feedback on whether the summary chapters are 20 useful and effective. Throughout Chapter 3 21 we've brought in more information from 22 previous documents and in fact we've done this Page 97 1 throughout the document. We've also included 2 updated NEI data and including detailed data 3 for piston engine aircraft emissions. 4 We have more on non-air media, 5 including more comparing air lead with soil

6 and sediment lead. We also have more

7 discussion on alternatives to FRM collection 8 methods as well as more interpretation of the 9 measured concentrations. For example, 10 bioassays related to particle size, 11 distribution, wind speed and direction.

12 We have several new sections in 13 the document and throughout this presentation

14 the new sections are in the red text. We have 15 other non FRM analysis methods for total lead. 16 A section on background lead concentrations 17 with trans-oceanic transport included.

18 And also in addition to the

19 source- oriented monitor concentrations that 20 were presented in the first draft, we also

21 have concentrations from non source-oriented 22 monitors presented. So in the charge for202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 Chapter 3 we're requesting comments on these 2 and other changes both the content and the 3 presentation of the material. 4 Moving on to Chapter 4, in order 5 to better reflect the complexities of the 6 multi pathway exposures, we've included a new 7 section on exposure assessment methodologies. 8 In Chapter 4 we also made revisions to the

9 toxicokinetics and biomarker sections of that 10 chapter. Across these sections there's more 11 consistency in the use of terms. 12 And the air lead, blood lead 13 slopes were also re-evaluated considering the 14 range of the data that's in the studies. We 15 have more on bone lead and also quite a bit 16 more on past versus current exposures and what

17 this means in term of blood lead level. 18 This is a new figure that is in 19 Chapter 4. It shows the decline in blood lead 20 level over time and different NHANES, age 21 cohorts on the y-axis the mean blood lead 22 level is plotted on the log scale. So you can Page 99 1 see the older cohorts in green, their blood 2 lead level quickly drops off. And compared to 3 the younger aged cohorts, their blood lead 4 level currently is still higher. 5 In the younger age cohorts, those 6 born after 1980 especially, you see the effect 7 of blood lead level peaking during early 8 childhood and then quickly dropping off. But 9 what's evident hopefully from this figure is 10 that exposure history for the different 11 cohorts is very, very different. 12 And this may not be reflected in 13 the blood lead levels in the epidemiology. So 14 for Chapter 4 we are requesting feedback on 15 the interpretation of the science that was 16 evaluated and also specifically the discussion 17 on uncertainties and limitations, whether that 18 was adequate. 19 As you can see here moving on to 20 Chapter 5, the causal determinations have not 21 changed. And we do continue to make causal

22 determinations for these broad outcome Page 100 1 categories by evaluating the coherence of the 2 evidence across disciplines and across the 3 spectrum of related endpoints. And we adopted 4 this approach because specific pathways within 5 the broader categories of health outcome are 6 interrelated and we feel that they draw

7 coherence from each other. 8 We have changed substantially 9 however, how we are presenting the information

10 in our causal determination summaries. We 11 have sort of a summary causal paragraph that 12 highlights the endpoints that comprise the 13 weight of the evidence for the causal

14 determinations. And also includes the at-risk 15 population and life stage. 16 And in Chapter 5 this paragraph

17 comes at the end of the causal determination 18 summary. It usually begins in summary. It's 19 edited for Chapter 2 and appears first in

20 those summaries with the other evidence 21 following. And we edit it down further for 22 the executive summary. There's no blood lead Page 101 1 levels in the executive summary, but we do 2 have those blood lead levels put in context in 3 the Chapter 2 summary as well as in the 4 summary sections that follow at the end of 5 Chapter 5. 6 Just to give you a few examples, 7 these are some key phrases from the causal 8 determination summary paragraphs. For nervous 9 system effects shown here we say based most 10 heavily on cognitive function deficits and

11 inattention. And these are observed in

12 children. 13 It wasn't actually our intention 14 to weight ADHD as heavily as cognition. And 15 it was really, our intention was to present 16 that evidence as supporting inattention. So 17 we're reevaluating based on some preliminary 18 comments how that text was written up.

19 For immune effects the evidence 20 points to stimulation of TH2 responses. And 21 most of the evidence is from toxicology in 22 this case with supporting evidence from202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 epidemiology in children. The left side of 2 this figure shows increased TH2 activity and 3 the right side suppressed TH1 activity. And 4 all of the TH1 activity is from toxicology, 5 but there are several recent epidemiologic 6 studies that add to the evidence for IGE, 7 asthma and allergy.

8 And we did conclude that 9 confounding by SES and allergen exposure 10 didn't fully explain those associations 11 observed in children largely because you see 12 an independent effect on IGE in the animal

13 studies. And also several of those studies of 14 asthma and allergy in children did adjust for 15 potential confounders, maternal education, 16 allergen exposure and housing factors. 17 This is an example for

18 cardiovascular effects. We concluded the 19 causal relationship for cardiovascular 20 effects, but long term exposure to lead in 21 adults. The endpoints were increased blood 22 pressure and hypertension. Page 103

1 And we also tried to very 2 explicitly acknowledge the uncertainties 3 regarding the level, timing and frequency and 4 duration of exposure that contributed to the

5 blood lead levels or the bone lead 6 measurements in the epidemiologic studies. 7 And acknowledge also explicitly that the 8 cohorts studied were likely to have had higher 9 past than current exposures. 10 So we are requesting comments on 11 how well Chapters 1 and 2, those summary 12 chapters, reflect revisions to Chapter 5. And 13 specifically revisions to characterize the 14 weight of the evidence for specific endpoints 15 within those broad outcome categories.

16 We also have several new sections 17 in the health evidence write ups. A lot of 18 these sections originate in Chapter 5, but 19 they're carried through to the executive 20 summary and also Chapter 2. There's a section 21 on public health significance. It is in the 22 nervous system section of Chapter 5 and also Page 104 1 brought forward to Chapter 2 in the executive 2 summary. 3 The lead exposure and effects in 4 children is actually in Chapter 2, but draws 5 pretty heavily from the life stage write up 6 that's in Chapter 5. There's a confounding 7 section in the nervous system effects and 8 we've also tried to bring in confounding and 9 as well as discussion of the strengths and 10 limitations of the epi studies in general 11 throughout the chapter. And again we've more 12 explicitly acknowledged the uncertainties 13 about exposure and acknowledged them, but not 14 only in the studies of adults but also in

15 older children. 16 We also did quite a bit of work to 17 focus the evaluation of the toxicology

18 evidence on the studies that are most relevant 19 to humans. In the mode of action section, 20 that's the first part of Chapter 5, there are 21 some higher level studies but they are pointed 22 out, indicated in the text. We also enhanced Page 105 1 the integration of the animal toxicology and 2 the epidemiologic evidence. 3 So all of these revisions together

4 feed into our causal determinations and we're 5 requesting feedback on whether the evidence is 6 accurate and well described, especially 7 reflecting the weight of evidence for the 8 endpoints within the outcome categories. We'd 9 also like comments on the integration between 10 toxicology and epidemiology as well as whether

11 our conclusions on the blood and bone lead 12 levels in the epi studies and whether 13 inferences regarding lead exposures are

14 consistent with the evidence. 15 This is a summary slide for 16 Chapter 6. The factors on the far right of

17 the slide are factors that have been examined 18 in epidemiologic studies that looked at effect 19 modification. So our chapter continues to be 20 organized around these factors with supporting 21 evidence from the toxicology. But for lead we

22 also have another section that looks at202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 factors that influence exposure. 2 And there's a new section,

3 residential factors there. And for the second 4 draft of the ISA we've taken out the factors, 5 the physiological factors that influence

6 internal distribution of lead from the effect 7 modification write up and placed them in their 8 own section that comes first in the chapter. 9 The other thing to point out here

10 is that we've refined the discussion at the 11 beginning of Chapter 6. And we're using the 12 term at-risk rather than susceptible. And

13 this follows the revisions that were done for

14 the ozone ISA. And we also indicate when 15 there's only limited evidence available for a 16 factor, again following what was done with 17 ozone. So we are requesting comments on all 18 of these revisions and specifically whether 19 the designation of some of the factors as 20 having limited evidence is appropriate. 21 Moving on to Chapter 7, we've 22 added figures and text to support concepts Page 107 1 related to bioavailability. The aquatic 2 section was reorganized to separate lead 3 effects into fresh and salt water systems.

4 And we've also added additional information on

5 concentrations at which all of the effects are 6 occurring. 7 We have separate causal

8 determinations now for the terrestrial and 9 aquatic systems for each of these endpoints.

10 And these revisions in fact resulted in some

11 revisions to the causal determinations that 12 were made. And where they have changed we've 13 indicated those changes in red. 14 We are requesting comment on these 15 and all the various revisions to Chapter 7 as

16 well as the rest of the document. And I think

17 I will end there. 18 DR. FREY: Okay. Thank you. Any 19 questions of clarification from members of the 20 panel? Anything EPA that you would like to

21 add? 22 DR. VANDENBERG: The only comment Page 108 1 I would make is that in the presentation here 2 we had underlined certain words. It was just 3 to help smoothly run through the charge 4 questions. The charge questions are actually 5 as presented to the panel in their entirety. 6 DR. FREY: Okay. Good. Well 7 since there seems to be, Dr. Korrick. 8 DR. KORRICK: Sorry for the last 9 minute question, but can you just explain a 10 little bit about process here? So for example 11 you have external writers and you have 12 internal writers, in terms of how the comments 13 you got from the first draft are then 14 responded to. 15 You know, what's the process? Who16 makes the changes? How is the document re17 edited and stuff? I mean it's a little bit 18 relevant to some of my comments so it would be 19 helpful to know more. 20 DR. VANDENBERG: Sure. Thank you. 21 So we have external expert authors that we get 22 contributions from in terms of specificPage 109

1 sections of chapters and our staff have 2 ultimate responsibility to take that input to 3 basically work it in, to review it, to make 4 sure that we have ownership of it. 5 So it's our document, but we 6 benefit from certain areas of expertise that 7 may be beyond the areas of expertise of some 8 of our staff or are complementary to that. 9 And so the document though ultimately goes 10 through a review process within our staff and 11 then ultimately I'm ultimately responsible for 12 it. So we're reviewing it, refining it, cross 13 reading across different chapters and bringing 14 it together for that total integration which 15 is what we're striving for. 16 DR. POUNDS: I wanted to follow up 17 on what Susan asked about. Because in looking 18 at the second draft compared to the first 19 draft and some of the specific comments that 20 were made by both the consensus sections and 21 then some of the individual comments, and 22 we'll discuss this further during the course202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 of the day, there were several notable 2 instances in which there was no change made. 3 Now I appreciate the fact that the 4 agency might disagree with some of the advice 5 and guidance and that's fine. But it was 6 difficult to, for us at least, you know, going 7 through this and making these comments and 8 then not seeing any changes to understand 9 whether or not they had been looked at and 10 considered to be not valid or just not looked

11 at or whatever. 12 So I'm, you know, normally when 13 you review a document like you review a 14 manuscript, not a 1,000 page one, but you 15 know, you put in your reviewer comments and 16 then the authors get back to you. Well you 17 know, they respond to all the comments. And 18 certainly in the National Research Council 19 methodology when it goes out for external 20 review, you know, they review all the 21 comments. They don't necessarily accept them 22 all, but they review them all. Page 111

1 So is there a way we can find out 2 or get feedback on whether or not, you know, 3 why you didn't, you may have chosen to ignore 4 some of the suggestions? 5 DR. VANDENBERG: Sure, thank you 6 for that. Just to be clear, we carefully 7 consider all the comments. Now there may be 8 some that we don't necessarily, we consider

9 them comments and recommendations for our 10 consideration. One of the things that you 11 have not received is the reply back in terms 12 of the agency's response to the CASAC letter 13 is, I don't believe that's actually -- 14 DR. FREY: We actually just 15 received it, I think a few days ago. And I 16 believe everyone on the panel received it.

17 It's a letter from the administrator to Dr.

18 Jon Samet. And then attached to it is 19 approximately four pages explaining what

20 revisions were made. 21 DR. VANDENBERG: Right, so thank 22 you. So that came relatively late in the Page 112 1 process and I apologize for that. But 2 essentially what we do is we consider the 3 comments. We discuss them internally, quite 4 a bit actually and what we are doing is I 5 think reflecting our view of those. And there 6 may be some either miscommunications or 7 misunderstandings about some things.

8 We have in some instances tried to 9 provide red line to show the changes that you 10 can see. And we find that to be very 11 cumbersome actually because the documents 12 change so much that everything looks like it's 13 changed although some times it's just 14 reorganizing things. And so unfortunately 15 that's a hard response because it's not 16 supporting your review and then you've got a 17 giant document to review yet again. 18 But I think that what I would say 19 is that we very much do respect and consider 20 the comments that are received and you know in 21 some instances we find that maybe there's a 22 misunderstanding or misinterpretation or we Page 113 1 simply don't agree necessarily with the

2 recommendations.

3 DR. MICHAEL KOSNETT: And I 4 respect that. But, you know, I don't know if 5 I'm speaking for myself or my colleagues, but 6 if other people feel differently please tell 7 me what you think. But I would like to 8 encourage you to request, you know we put a 9 lot of time into doing the comments and some 10 of them are consensus, some of them are

11 individual.

12 Wouldn't it be reasonable to ask 13 that EPA, you know, respond in the table or 14 whatever to all the comments. You know, okay 15 like there's a comment, well like for example, 16 add a column looking at the shortcomings of 17 this study or mention this particular study. 18 And you could say yes we have added, you know, 19 a sentence or two about the shortcomings of 20 that study. Or no we decided not to because 21 we don't agree those are shortcomings. 22 But I think just to satisfy the202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 public health community and everyone else that 2 this input was effective, why couldn't you do 3 that? I mean other agencies like, you know, 4 California Department of Health Services which 5 does a lot of criteria documents, at the end, 6 you know, they get all the comments in and 7 then they have a whole section. This comment 8 came in, this is how we responded. This 9 comment came in, can you do that for us? 10 DR. VANDENBERG: I would say the

11 intent of our consensus for our letter back to 12 the agency is intended to go through the 13 consensus letter from the panel and then 14 respond to the major comments that we see 15 there. What we have found in the past is 16 going through over 100 pages of comments from 17 the panel is appreciated, but it's very

18 resource intensive for us.

19 And so we have elected not to do 20 the comment response, comment response, 21 comment response. Now I understand your 22 interest and perhaps the panel wants to make Page 115 1 some recommendations at some point. 2 DR. FREY: Yes. If I maybe could 3 weigh in a little bit. I think this comes up 4 on probably every panel. And so this 5 discussion I've, I think some of us have 6 probably heard this on other panels as well. 7 And I think it is a bit of a give and take 8 between the panel and EPA. 9 As a reviewer, I agree with your 10 position that, you know, it's nice to see the 11 point by point response to comments. On the 12 other hand, we provide as John said, 100 pages

13 of comments. And I think as John alluded to 14 this attachment to the letter that just came 15 back from the administrator sort of attempts 16 to respond to CASAC to assure us that comments

17 were addressed. 18 And if you haven't had a chance to 19 look at it, you know, I think it's a bit vague

20 I think in terms of how the comments were 21 addressed. And I think it may not address the 22 comments that weren't addressed or it may not Page 116 1 explain that we received this particular 2 comment. We chose not to respond for whatever 3 reason. And I think that's what you're in 4 part looking for. 5 And so it may be that in the

6 framework that's been used across several 7 panels may be a little bit more clarity on 8 this kind of response from the agency would be 9 helpful to us so that we don't, I think the 10 bottom line in the beginning of your question 11 was, we don't wonder whether the comment was 12 ignored. Or maybe it was thoughtfully 13 considered and then set aside for a good 14 reason. And it would at least help us at the

15 outset to understand that.

16 DR. MICHAEL KOSNETT: And that 17 informs the public health, our evolution of 18 knowledge about it. But I mean this is a 19 profoundly important document because it 20 becomes the federal government's major 21 assessment of lead. You know, the CDC is 22 cutting back on its lead poisoning branch and Page 117 1 a lot of these issues, you know, I don't how 2 many more documents CDC's going to put out on 3 it based on their current funding cutback. 4 So this becomes a major document 5 and for these kind of, for some of the 6 statements in here where, you know, you've 7 gotten considered opinions which are sometimes 8 at odds with what's written, it would be 9 reasonable for the public benefit, I think, to 10 respond to them. And again, I know it's 11 resource intensive, but that's typically 12 what's done by other, in other venues like the 13 National Research Council reports. 14 DR. VANDENBERG: Maybe just a, 15 what I could do is recognizing again our 16 approach has been to provide a letter back 17 through the administrators basically is to 18 provide more detail. And I think that's a 19 very reasonable thing that we could do.

20 I would hesitate to commit to do 21 comment response, comment response for a 100 22 page modification, you know, but I do believe202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 that would be visible way for us to be more 2 responsive. Certainly to show the respect

3 that is due for the comments that we've 4 received because we very much do consider all 5 of them. But we perhaps have not gone as far 6 as we certainly could do to provide more

7 feedback.

8 DR. FREY: And I think in 9 responding the priority I think clearly would 10 be on the main points in the letter from CASAC

11 to the administrator and the consensus 12 responses to the charge question. But 13 recognizing that sometimes in the response to 14 the charge question there is a reference to

15 more detail and an individual member comment 16 that supports that consensus. 17 And so occasionally diving into 18 that is worthwhile. But I tend to sympathize 19 that it's probably, well as much as we would 20 like to have the point by point response to 21 100 pages of individual member comments, that 22 may not be a realistic thing in terms of your Page 119 1 time availability. 2 But I think we've made the point. 3 Are you satisfied for the moment? Because 4 there are a couple other questioners. I know

5 Dr. Goodrum and Dr. Wasserman and --

6 DR. GOODRUM: Well Michael had 7 asked if other panel members had felt the same 8 so I was just going to weigh in that I thought 9 some form of a response to the comment. 10 Perhaps if it's focused on those, you know, 11 comments that maybe weren't addressed and with 12 the assumption that the ones that aren't 13 listed there were addressed in some way. 14 That might be a happy medium. But 15 I found it a challenge as well to go back and 16 kind of sift through certain sections in order 17 to identify, you know, exactly where changes

18 had been made. 19 DR. GAIL WASSERMAN: I just think 20 going forward that it would be easier for us

21 to review the draft if we had that context in 22 front of us rather than, to sort of try to Page 120 1 keep it in our minds. Because there were a 2 lot of changes. It's hard to track where a 3 specific issue may have been put or not put.

4 DR. CORY-SLECHTA: I don't 5 disagree with my colleagues, but on the other 6 hand, and you may want weigh in on this as 7 well, I think reviewing the second draft as a 8 point by point response to what you said 9 initially fails to give you the overview of 10 something new. That's my concern about that, 11 is that now you're just doing it as a 12 manuscript. 13 That did they answer A did they 14 answer B instead of looking at something in a 15 holistic way which has had other changes that 16 we may not have included. So I'd be a little

17 concerned about that kind of a review.

18 DR. FREY: I think that's an 19 excellent point. Vanessa wants to add 20 something. 21 DR. VU: I just want to remind 22 folks that on the panel that the historical Page 121 1 practices for the agency to provide written 2 response with regard to the consensus advice 3 from the CASAC, not so much on the individual

4 comments. Of the individual comments we 5 append all of your panelist comments as for 6 information for the agents consider. 7 But the agency has been taking the 8 CASAC consensus advice and try and respond in

9 the letter from the administrator back to the 10 chair of CASAC. So I just want to highlight 11 that point. 12 DR. FREY: Other questions of

13 clarification? And don't be influenced that 14 that will keep us from our break. I don't see 15 any. Okay. Well thank you to both of you.

16 And we will take a 15 minute break. When we 17 resume we will take up with charge question 3 18 on Chapter 3. 19 (Whereupon, the above-entitled

20 matter went off the record at 10:32 a.m. and 21 resumed at 10:47 a.m.) 22 DR. FREY: Okay, we just wanted to202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 point out that everyone should have received 2 an email that had the EPA response to the

3 comments on the first draft ISA. 4 But just to point out that that 5 response is also on the CASAC website for the

6 first external review draft of the ISA and

7 there's a tab there where the mouse is 8 pointing for agency response. 9 And I suppose you could click on

10 that and then there will be a PDF link for the 11 agency response, which is a document. 12 So it's available online at any 13 time no matter where you are. If you can get 14 on the internet, you can read that. And it 15 all has come to your inbox as well. 16 Okay, we're going to start with 17 the response to the charge question on Chapter 18 3. And I already kind of discussed the 19 process for charge questions. 20 So we've already, in my view, 21 dealt with the agenda item on discussion of 22 EPA charge questions in terms of process. But Page 123 1 we do have them up on the board in terms of 2 the content of the charge questions. 3 And so the chapter three is on the 4 source to concentration aspects of lead. And 5 there have been a number of changes that are

6 included there. 7 EPA is asking us to comment on the 8 adequacy of the changes made to the chapter 9 and recommend any revisions. Oh, could you

10 scroll down? Yes. 11 Okay, so the changes, the 12 revisions include elaboration of changes to 13 the National Emission Inventory, between the 14 '06 Air Quality Criteria document and this 15 ISA, discussion of limitations of the TSP 16 federal reference method sampler, which we've 17 already heard a little bit about. 18 Removal of some questionable data 19 in response to a comment on the first draft 20 ISA. Addition of a background lead section 21 and supplementation of studies to look at the 22 relationship between air lead and lead in Page 124

1 soil. 2 So the charge question is 3 basically to comment on these revisions in 4 terms of their adequacy and where appropriate, 5 provide guidance that could refine the 6 scientific interpretation and/or improve the 7 representation of the science. 8 The discussants on the charge 9 question are Cliff Davidson, Phil Hopkey, 10 Chris Johnson and Rich Poirot, all of whom I 11 believe are present. 12 And the lead discussant is George 13 Allen. And I would propose to go in that 14 order starting with George and then have each

15 of the other discussants chime in. 16 And then as George and all the 17 lead discussants know that you should take 18 notes to try to summarize and reflect back 19 what are the key points in response to the 20 charge question. 21 And as a homework assignment for 22 each charge question group, you should, by Page 125 1 this evening, try to collate a first draft 2 response to the charge question in writing.

3 And that also hints at the 4 schedule. And for various reasons, we have to 5 kind of keep things moving along. 6 And I know we're all very, very 7 busy and I know many of us, those of us who 8 are academics are dealing with end of 9 semester, and so this is an extremely busy

10 time. 11 On the other hand, as we know, it 12 takes a while to get all these write-ups 13 through the pipeline to the point where they

14 become finalized as a letter to the

15 administrator. 16 And so, keep in mind that the more 17 you can do while you're here, the better, 18 right? And the less you'll have to do later. 19 We would like to get all the final individual

20 member comments within two weeks. 21 We would like to get a good draft 22 of the consensus response to charge questions202-234-4433 Neal R. Gross & Co., Inc. Page 126

1 within three weeks. And then there will be a 2 period where we'll have the panel have an 3 opportunity to review that. 4 As a panel, we'll have a

5 teleconference to discuss and finalize our 6 report that will then go to the statutory 7 CASAC for a quality review. 8 And then subsequently it will be 9 finalized for delivery to the administrator. 10 Okay. With that, I would like to turn the 11 floor over to George Allen. 12 DR. ALLEN: Thanks, Chris. All 13 right, Chapter 3 is substantially improved

14 over the first draft. And it was useful to 15 get the summary and the attachment to the

16 administrator's letter. 17 Unfortunately, I didn't have that 18 when I was writing my comments. So I tried, 19 in my best way, to summarize those changes, 20 but missed a few things. So this is good to

21 have. 22 It's very hard to really take Page 127 1 something this large and try to focus in on 2 what's changed. And there were a lot of 3 changes, especially in Section 3.5. Things 4 moved around and some new material was added, 5 which was good overall. 6 In general, I think the revisions 7 do address most of the panel's comments from 8 the first draft. And it was, as I said, it

9 was a little hard to focus on some of the new 10 material given that it was a moving target. 11 And so my first section of the 12 comments are not entirely relevant given the 13 new material on the changes. 14 And again, HERO continues to be 15 very useful and especially for some of the 16 older material or non-published literature

17 material that is not available at all to most 18 of us, and just lives in somebody's deep, dark 19 files and gets scanned in. 20 And to have that posted on HERO, 21 especially some of the older studies on the 22 lead Hi-Vol, inlet material, the McFarland Page 128 1 work was very, very useful. There are very 2 few copies of that out there. 3 One thing that still seems to be 4 hanging, and maybe it's because I'm from the 5 northern tier, but Section 3225 on wood 6 burning talks about that source in the context 7 of wildfires, forest fires, maybe controlled 8 burning issues. 9 But nothing in the context of 10 valley winter wood smoke, which obviously the 11 northern tier has quite a bit of. There's a 12 lot of PM exposure there. Usually it's not

13 measured. 14 Because there usually aren't sites 15 there. But when you measure it, there's a

16 lot. And we know there's lead in wood smoke. 17 And for that population, as I said 18 last time, it's likely that wood smoke is 19 their primary exposure pathway to lead, 20 because there certainly aren't any industrial

21 facilities for sources of lead near them. 22 And there aren't, in the hills and Page 129 1 valleys there are very few general aviation 2 airports. So that seems to me, and then 3 talking to a few others, to be worth taking

4 into consideration is the discussion of wood 5 burning issues. 6 As I noted earlier, the monitoring 7 techniques is substantially improved and, you 8 know, does now include specifically that the 9 issues regarding FRM Hi-Vol and the method 10 development. 11 It is difficult because it may not 12 really be within the traditional scope of an 13 ISA process, but to get maybe an expanded

14 discussion on the state of the aerosol 15 science, that could support additional 16 alternatives that we talked about this morning 17 with Bob Vanderpool. 18 And again, I know that's really 19 not a review of the existing literature, per 20 se, but it could be a review, because the 21 literature is very sparse, as Bob pointed out, 22 and there's not much out there on this topic.202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 There's not a lot of data, but 2 there is a lot of knowledge. There are people 3 and sources that can really inform the process 4 as to what we actually could do. 5 Again, I don't know if that's good 6 to have in here, but it seems to stop a little 7 short from what I think would be good to have

8 in there. 9 Section 3.5 probably was the most 10 widely revised, which is a good thing. 11 Overall, there are a lot of improvements.

12 But there seem to be a lot of need 13 for proofing and editing, because in some 14 parts of this Section 3.5 were actually really 15 hard to read and comprehend and digest and

16 assimilate for several reasons. 17 Sometimes just simple errors and 18 sometimes just the material was not presented 19 in a clear way. Or it was kind of little 20 factoids were plopped down but not always

21 connected.

22 And it left the reader to do a lot Page 131 1 of that synthesizing and integration of the 2 material, at least that's my impression. 3 And in more than one case, since 4 the sampling method is extremely important for 5 lead, the larger lead, there were some cases 6 where it wasn't mentioned explicitly in the 7 text. Yes, I'm sure it's in the references. 8 But for reading through the text,

9 there seemed to be some method issues that 10 were missing there. 11 Some specific comments, very 12 quickly. I think I won't go over the ones I 13 had in the writing. 14 But one thing that struck me was 15 that the omission of the Cooper, and now it's 16 actually Paul, the exact 620 XRF sampler is a

17 commercial method for online realtime lead. 18 Probably more viable than some of 19 the other ones like C's, John Ondoff's water 20 extraction technique for highly time resolve 21 sub-daily lead measurements. 22 And on general aviation, airport Page 132 1 monitoring, just a quick sidebar, some of the 2 airports, especially the one nearest me in 3 Nantucket, we actually will have some idea of 4 where that stands early fall because if 5 there's an issue with Nantucket, it's going to 6 be during the June to September period because 7 it's a very, very seasonal airport. 8 And what's interesting is that 9 actually if you, and this is maybe why EPA 10 chose it, the concentrated activity in the 11 summer makes, for those three or four months, 12 the emissions inventory, effective inventory 13 much higher than the .7576 that's on the

14 annual basis. 15 It might be twice that, which 16 makes it right up there with Deer Valley in 17 Phoenix as, for those three or four months, 18 one of the largest general aviation airport

19 sources of lead. 20 So it will be a very interesting 21 site to look at and we should get the answer 22 probably sooner than later in that context. Page 133

1 There are some other issues. 2 Probably, the thing that keeps coming back to 3 me is that we have to keep in mind that the 4 lead network is a 6th day sampling schedule. 5 And since lead is, at least, a 6 source oriented lead is presumably very log 7 normally distributed, you have to be very 8 careful what you do with statistics that are 9 not combinations of lots of different samples

10 or sites.

11 And sometimes the tables in this 12 section, Section 3.5.1.1 and some other 13 places, Table 3-8, Table 3-6, get down to 14 numbers that might actually come from a single 15 sample, and those are just worth a note that 16 they're highly unstable. 17 Especially if you're looking 18 across time at 99th percentile or max values, 19 you have to be very careful how you interpret

20 that. 21 Other than that, just some other 22 comments in my notes, but I don't need to get202-234-4433 Neal R. Gross & Co., Inc. Page 134

1 into them. Thanks. 2 DR. DAVIDSON: Okay. So in fact, 3 I echoed George's comment that there's been a 4 great deal of improvement in Chapter 3. 5 And I feel that substantively, the 6 chapter is in much better shape now. I have 7 a number of editorial comments that I can just 8 submit separately.

9 One editorial comment that has 10 come up in the past that I just want to 11 mention is that for some of the maps, 12 particularly, like, the county maps of the 13 U.S., rather than having colors that change in 14 a way that can be followed by the reader, 15 like, maybe you have all of the blues at the 16 low end and all of the reds at the high end.

17 You have black at one end of the 18 scale and a very dark blue at the other end of 19 the scale. And you can't tell them apart. 20 And so obviously, that really 21 becomes a problem because you can't tell 22 whether this particular county is the lowest Page 135 1 or the highest. So I'll just mention that.

2 And then there are a bunch of 3 other editorial comments that I'll just

4 submit. So that's all I have. 5 DR. FREY: Okay, thank you. Dr. 6 Hopke? 7 DR. HOPKE: In the previous 8 version, we had a number of comments on the

9 size distribution issue in terms of we had 10 some problems with how it was presented. 11 But that wasn't meaning that we

12 wanted to have it taken out. We wanted to 13 have it improved. And at the same time they 14 published this Cho(i)/Troy, et al. paper, which

15 includes ORD and OAQPS staff, but is not noted

16 in the ISA.17 So if you're going to have a two18 tiered sampling system based on both Hi-Vol 19 and Low-Vol PM10, then we've got to have an 20 adequate discussion of the comparison of the 21 two and the interrelationships that exist

22 between lead and TSP and lead and PM10. Page 136 1 Otherwise, how do we have a basis 2 for having two different types of FRM's,3 depending on when you're in a source or non4 source area. 5 So this really is critical that we 6 get a good section back in there that properly

7 discusses the size distribution issue. 8 The other thing that's missing is, 9 in the sampling analysis section, there's no 10 discussion of passive samplers. And we've had 11 a couple of papers published in the last year 12 which show how one can really look at 13 microscale intervariability of coarse 14 particles across an urban region.

15 Give us a lot more information 16 than a few active samplers that we can afford 17 to run during the same period. 18 And so I suggest that this is a 19 useful thing to at least note that for people 20 who are looking at really trying to get out 21 the heterogeneity of exposure across a census 22 track or somewhat larger scale urban area, Page 137 1 these samplers can be very useful.

2 And all of the information is 3 needed in there so that they could look at 4 inter-urban spacial variability and non-source 5 areas both in terms of spacial and temporal, 6 because as two time periods measured in 7 Rochester, four time periods measured in 8 Syracuse.

9 And so there's data out there that

10 I think would be useful for them to include 11 here, and I think they should consider it. 12 The other major bull under my 13 saddle is the continued use of the Spearman

14 correlation coefficient. The fact that these 15 things have the same rank order has nothing to 16 do with whether they come from the same

17 source. 18 It may be driven largely by 19 meteorology, or other kinds of things. The 20 lack of a strong Person correlation 21 coefficient means that they aren't really very 22 strongly related.202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 And I think you're getting a false 2 presentation of the interrelationship of lead 3 with other pollutants. And to then highlight 4 that as part of the chapter summary is, at 5 best, bogus.

6 This is how to misuse statistics. 7 I'm not sure what point they're trying to 8 make, but it's not one that's made by the data 9 and the work they've done. And that's got to

10 come out. 11 DR. FREY: Okay. Dr. Johnson. Or

12 was -- 13 (Off microphone comments) 14 DR. FREY: Okay.

15 DR. RABINOWITZ: The trouble 16 because it's a Spearman correlation or any

17 correlation? 18 DR. HOPKE: Spearman, because all 19 you're looking at is relative rank order. And 20 that doesn't tell you anything about the 21 underlying linear relationship amongst the 22 pollutants. Page 139

1 The fact that they're rank order, 2 even if they're widely varying really doesn't, 3 you know, you're trying to make the hidden

4 case that these are related to other kinds of 5 criteria pollutants, it would seem. Except

6 that it doesn't make the case.

7 DR. RABINOWITZ: So if a different 8 type of correlation were used, product moment

9 -- 10 DR. HOPKE: Yes, right.

11 DR. RABINOWITZ: -- I think that 12 might be okay. 13 DR. HOPKE: Right. If you had a 14 product moment, then one could look at 15 underlying vectors that showed that they were, 16 in fact, interrelated in some way. 17 I mean, there would be a base for 18 looking at whether there really is a 19 quantitative relationship between these other 20 criteria pollutants and the lead. 21 DR. RABINOWITZ: Thank you for 22 your indulgence. Page 140 1 DR. FREY: Okay, sure. Yes, I 2 mean, well as I understand the Spearman

3 correlation is a value of one would indicate 4 monotonicity in the relationship, whereas if 5 you're looking at something like a Pearson 6 correlation, it's linearity. And you're more 7 interested in linearity than monotonicity?

8 DR. HOPKE: Yes. 9 DR. FREY: Okay. 10 DR. HOPKE: If what we're trying 11 to do is look at the real relationship between 12 other pollutants and their sources and the 13 sources of lead, which is what's seemingly 14 implied in that sector. 15 DR. FREY: Okay, thanks. Was 16 there a clarifying question? 17 DR. POUNDS: Just maybe a footnote 18 to come back to that. My experience with 19 correlation analysis is that, you know, the 20 Spearman rank correlation is actually, 21 mathematically it's the Pearson product 22 correlation performed on the ranks. Page 141

1 And I think I understand the 2 concern about overly drawing conclusions based 3 on ranks, but I think there is value, there 4 are purposes for using non-parametric

5 correlation methods which have to do with 6 minimizing potential influences of outliers, 7 for example. 8 Or not applying a model, which is 9 really what Pearson product-moment correlation 10 assumes is some model relationship.

11 And so I think there are merits 12 for using non-parametric methods, and I would

13 be interested to have further discussions on 14 that before we draw consensus opinion to

15 remove that. 16 DR. FREY: Okay, good. Well, Dr.

17 Johnson?

18 DR. JOHNSON: There were three 19 charge questions, as I read them, anyway, at 20 least that I responded to. My general 21 expertise is more in the area of fate and 22 transport than in the atmospheric and aerosol202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 chemistry, so I'll leave that to the others to

2 deal with. 3 One question had to do with the 4 addition of the materials, well all the

5 materials that were added to the document. 6 One of the things that was mentioned in 7 particular was the additional material on the 8 measurement, the measurement methods. I 9 thought that was fine, but again others will

10 have more detailed comments on that. 11 The section on background lead 12 concentrations that was added was, I think, a 13 good idea. I think it may still need some 14 work. The definition of background used this 15 policy relevant background. I understand, 16 from the EPA's perspective, regulatory 17 perspective, it's important to sort of come up 18 with a number that represents what, you know, 19 we can't regulate. We can't regulate what, 20 you know, South Korea does and how that 21 effects how much lead we get here in the 22 United States, that sort of thing. Page 143

1 At the same time, it's troublesome 2 to try to figure out what that number is. So 3 easier, at least conceptually, to come up with 4 say a geochemical background based on various 5 kinds of isotope work like Mike does and that 6 sort of thing. 7 In any event, regardless of 8 whether, you know, the policy relevant 9 background is the target you want to get at, 10 you know, I read that section and I never 11 actually came up with any sense of what those 12 background numbers might be that you would 13 propose. 14 I think the section pretty much 15 reads as a description of why you can't come 16 up with policy relevant background numbers. 17 So maybe I need to read it again a couple more 18 times to get at that. 19 But in any event, I think it's 20 really quite unclear what the EPA or what the 21 authors think might these background levels

22 be. Page 144 1 The third specific addition that

2 we were asked for feedback on was the section 3 in 3.6.1 relating soil lead to air lead. And 4 I thought that was really quite useful what 5 you did in that section. So I thought that 6 was quite nice. 7 Second charge question had to do 8 with whether the materials clearly, succinctly 9 and accurately provided a, I had to chuckle a 10 little at succinctly, but I have to also say 11 that, you know, the reason that the document 12 is what it is is because of probably the 13 comments that we came up with at our last 14 meeting. 15 So hard to call a 200 page chapter 16 succinct, but you know, it is what it needed 17 to be given the feedback that you had gotten

18 from us. 19 So finally, the third charge 20 question was to provide guidance that may 21 refine the scientific interpretation. 22 I think, you know, in terms of Page 145 1 soil and water chemistry and fate and 2 transport type things that I'm interested, I 3 think the chapter, in the first draft, did 4 quite a nice job. 5 The changes that have been made 6 have not changed that. It's still quite good 7 at laying out a conceptual model for the

8 behavior of lead.

9 Just more of a comment than a 10 suggestion. One of the things that's really 11 clear in reading those parts of the chapter is 12 that there seems to be very, very little work 13 being done in the United States these days on 14 the environmental, well I shouldn't say 15 environmental, that's too broad of a word, but

16 it's behavior of lead in soils and natural

17 waters. 18 And as these cycles go on, these 19 five year cycles go on, I can only imagine

20 that this document the next time around and 21 two times around from now, assuming that this 22 process goes forward, is going to get just202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 that much harder to write because you're going 2 to be relying more and more and more on 3 research that's being done in places that 4 might not be analogous to the United States. 5 So that's just more of a comment than 6 anything.

7 DR. FREY: Great. I should have 8 mentioned this earlier, and just as a reminder 9 to everybody that after we go through the 10 comments from the discussants on a charge 11 question, we will have an opportunity for 12 anybody on the panel to add or ask questions 13 related to any of the charge questions. 14 So you know, if a topic comes up 15 that you want to say something about and it's 16 not on your charge question, you will have 17 that opportunity. And Rich Poirot, you have

18 the floor. 19 MR. POIROT: Thanks, Chris. And I 20 agree with everyone's previous comments that 21 the chapter has been substantially improved

22 since the last revision. Page 147

1 I also wanted to echo George's

2 comment about HERO is a terrific tool. I mean 3 congratulations, that's a great thing. 4 By the way, I would like to be 5 allowed to use it indefinitely, even after 6 this review process is over. If I can sign up 7 for that list, wherever it is. It's a great

8 tool. 9 I generally think, also, that 10 there have been improvements to the chapter in 11 each of the specific areas mentioned in the 12 charge question. With possibly the one 13 exception that Phil mentioned of the removal 14 of that comparison of lead measured in 15 different particle sizes.

16 We had noted what seemed to be 17 some problems with it last time, but we were 18 hoping it might be fixed rather than just 19 removed, because I think as much information 20 as you can provide on the lead in different 21 particle sizes in the ambient air would be 22 important. Page 148 1 And along those lines, if that 2 analysis could be redone, or you might even

3 revert to the older Cavender and Schmidt memo

4 that came out last time that included most of

5 that same historical data. 6 But what we're especially 7 interested in among other things is that size 8 distribution changing over time and if so how, 9 and where and in proximity to what kinds of 10 sources and that sort of thing. 11 The Cho, et al. paper also would 12 be an excellent thing to just reproduce a 13 table from that paper that's kind of the same 14 idea but from a literature review perspective. 15 And then the third suggestion I 16 had along those lines is I noticed that 17 throughout the chapter you had at least seven 18 different studies that were all based on, 19 recent studies based on Moody samplers. 20 So, and I've found three or four

21 more in the literature. What about 22 summarizing all of that fairly detailed size Page 149 1 distribution data in a single table or 2 graphic, if it should work out? 3 But again, as I say, you know, how 4 that's changed over time or maybe seasonally 5 or any more information along those lines

6 would be useful. 7 And in particular, also making the

8 connection between what's in the ambient air 9 and then in Chapter 4, how does the size 10 distribution effect ultimately the uptake and 11 absorption of lead, which I thought could be 12 improved a little bit. 13 I agree that the discussion on the 14 limitations of the Hi-Vol TSP sampler is much 15 improved and so forth. However, it doesn't 16 really seem to be pointing towards the what

17 next. 18 And so Bob Vanderpool's 19 presentation from this morning was especially 20 helpful along those lines. 21 You know, arguably, this kind of 22 methods development, it doesn't belong202-234-4433 Neal R. Gross & Co., Inc. Page 150 1 necessarily in the ISA on the one hand. 2 But on the other hand, since we 3 proceed with this thing in a sequential 4 process and we're kind of maybe halfway 5 through, we would like to see that work get 6 done earlier rather than too late to be, once 7 again, taken into consideration in possible 8 revisions to the sampler. 9 Let's see. Oh, and then I guess I 10 thought that, you know, there's this sort of 11 justification for a continued use of the TSP 12 sampler that it's sort of in recognition of 13 the importance of the size of all, or however 14 it's said, of all particles of all sizes. 15 But that's really kind of squishy. 16 You know, and what is the importance of lead 17 in the air in all particle sizes? And is that 18 importance equal for all particle sizes, 19 because that's kind of what this TSP approach 20 of let's glop it all together and count every 21 particle size equally is sort of based on a 22 presumption of. Page 151

1 So it seemed to me that more work 2 along those lines could be useful. That sort 3 of leads me over into Chapter 4 a little bit. 4 But I think the two things need to 5 be linked better. There's very little 6 information in Chapter 4 on how particle size, 7 especially particle size from ambient air lead 8 really effects, let's say, the transport of 9 lead particles to surfaces from which they may 10 be taken up on your hands. 11 And then how does particle size 12 effect the take up of lead on your hands and 13 then how does particle size effect ingestion. 14 So a little bit more along those 15 lines I thought would be helpful. Maybe 16 that's a Chapter 4 issue, but linking the two, 17 I think would be helpful. 18 I thought the air lead, soil lead 19 discussion was very helpful. I ended up 20 noting kind of a large body of literature for 21 which Mark Laidlaw, I think, is the principle 22 author, the ringleader or predominant Page 152 1 spokesman. 2 But there are quite a few papers 3 in this sort of same general area that argues 4 that historically deposited soil lead is, in 5 fact, the single most important source of lead 6 uptake in an urban environment. 7 And part of that argument relates 8 to seasonal changes in blood lead. And 9 apparently there are many causal or 10 contributing factors that may be driving that, 11 one of which they argue is a seasonal increase 12 in air lead concentrations, which I wasn't 13 really able to find looking at the seasonal 14 patterns in the lead data.

15 But it did lead me to reflect a 16 little bit on the section in the chapter on 17 seasonal patterns of lead. There are some 18 tables or chapters, I guess, figures on Pages 19 393 through 396 that present seasonal patterns 20 of lead measured in different particle sizes. 21 But they're kind of box whisker 22 plots based on aggregation of all the data Page 153 1 from all the sites in those particle sizes. 2 They convey almost no information whatsoever.

3 You can look at them and there's 4 no seasonal pattern perceptible in any of 5 those plots where they've aggregated all the 6 data from all the sites together. 7 But I included them in my written 8 comments just as kind of a quick look at some 9 of the seasonal patterns that you can find if 10 you look in different parts of the data in 11 different regions and so forth that I think, 12 you know, could be helpful. 13 One, for example, is that across 14 all of the western sites, and the remote sites 15 in the improved network, there's a huge 16 springtime peak in fine particle lead in the 17 remote western United States, which I think 18 might be very consistent with the Asian 19 transport concept. 20 It's very small. It's less than 21 half a nanogram per cubic meter. But on the 22 other hand, it's very consistent across the202-234-4433 Neal R. Gross & Co., Inc. Page 154

1 whole rural west and so forth. 2 So I think, anyway, a little bit 3 closer look at some of the seasonal patterns 4 in different sites, different regions, 5 different sizes could be helpful. 6 But one other thing I thought

7 could be useful is I noticed there was one and 8 only one reference that I saw, a paper by Jim 9 Cass that looked at historical changes in soil 10 lead and noted, I think, that at higher 11 elevation sites with acidic soil, there hadn't 12 been much change in soil lead over time. 13 Let's say, I don't know, several decades. But 14 at lower elevation sites, there had been a

15 substantial reduction in soil lead. 16 But that was the only indication 17 that that might be so that I saw. And it's 18 probably not something there's much literature 19 on. But if in fact soil lead is diminishing, 20 if this lead is soluble and we keep pouring 21 all this pretty clean water through it, we 22 would expect that soil source to be Page 155

1 diminishing over time. So I guess that was 2 the last of my general comments. 3 DR. FREY: Okay, thank you, Rich. 4 And I know George is trying to figure out the 5 top three to five bullet points. 6 But we'll buy him a little more 7 time and see if there are questions or 8 comments from other members of the panel? 9 Yes, Dr. Von Lindern? 10 DR. VON LINDERN: My comments are 11 kind of integrated, so a lot of them I'll save

12 until later. 13 But pertinent to Chapter 3 and 14 picking up on the last topic before the break, 15 I've been making these same comments for six 16 years and haven't got an answer yet as to why. 17 But there's only 18 pages about

18 sources in this document. There's no 19 information about uses, rates of consumption,

20 the role of lead in the U.S. Commerce and 21 production, level of imports, exports, where 22 the waste ends up, where they go. Page 156

1 The old documents used to use a 2 principle, basic engineering principle of a 3 material balance about what's going on about

4 lead in the United States.

5 And I was in this section last 6 time about sources and so on, and one of the 7 big critiques was that EPA doesn't know 8 anything about this. 9 Well, EPA seems to know less about 10 it today, but has determined that it's not 11 policy relevant. Therefore, they don't need 12 to know. So if it's not showing up in U.S. 13 air, they don't care. 14 I don't see how you can proceed 15 through that first chart we saw here and let 16 other agencies review this, let other parts of 17 EPA review this information if you don't have 18 any knowledge about the sources, fate and 19 disposition of lead in the country. 20 So now we have a huge, huge 21 document, 1,100 pages that 550 pages are about

22 health effects at low level lead. But we seem Page 157 1 to have forgotten what was in the previous 2 iterations of this process, an important

3 factor. 4 And it becomes more distressing 5 because evidently what little information came 6 out in the last document says we're using 7 almost as much lead now as we were during 8 throughout lead years.

9 But we don't know where it comes 10 from, and we don't know where it's going, at

11 least as far as these documents are concerned. 12 So that's my seventh year of pointing that

13 out. 14 MR. ALLEN: Okay, could you

15 summarize that in a bullet? 16 DR. FREY: Well, it sounds like a 17 material balance accounting is what you're, 18 maybe is that the bullet point distillation of 19 what you just said? 20 Other comments? Yes, Dr. Johnson? 21 Or Dr. Allen, okay. I guess I wanted to maybe 22 give Dr. Vandenburg an opportunity, having202-234-4433 Neal R. Gross & Co., Inc. Page 158 1 heard what's been discussed, and maybe the

2 last comment. 3 Also, I guess I'm personally 4 interested in the context on the policy 5 relevant background. 6 And I think I could imagine some 7 arguments as to how that plays out in the 8 context of a strategy that assumes that the 9 ambient concentrations are very source 10 oriented and that that might be a kind of a 11 different scenario then we're used to seeing, 12 say with ozone or fine PM where there could be 13 large scale transport, even a hemispheric 14 scale transport. 15 But I guess I was curious if you 16 could comment on both the policy relevant 17 background and maybe this question about 18 whether a material balance discussion is, what 19 your thoughts on, or whether that's 20 appropriate or could be included. 21 DR. VANDENBERG: Thank you very 22 much. And again, thank you all for thePage 159

1 comments. I'll also introduce Mary Ross here,

2 who is the branch chief and Jen Richmond3 Bryant who has the lead on these chapters, 4 have joined me in the front here. 5 In terms of the policy relevant 6 background, that terminology has continued to 7 evolve, particularly with some of the other

8 ISA's. 9 For ozone, we've actually moved to 10 a different way of approaching the issue of 11 what is the source, what is the concentration, 12 where does it all come from, where is it 13 going? 14 Sort of along the lines of some of 15 the questions that were just raised. And so 16 what I would say is we would certainly, you 17 know, we understand the comments about this 18 larger scale global issue of the lead balance, 19 where is it coming from, where is it going?

20 I am a little bit cautious about 21 wanting to get into a global balance because 22 of the scope change there and how we would Page 160 1 actually redefine that scope. 2 And certainly would welcome any 3 suggestions or recommendations along those

4 lines.

5 But it is an area that I think we 6 do need to consider, because it may speak to 7 the exposure to North Americans, you know, the 8 U.S. population that we're focused on here in 9 terms of studying national ambient air quality

10 standards.

11 And so to the extent that it 12 relates to those set of, ultimately, policy

13 choices that is relevant information that we 14 need to figure out how to put the scope around 15 and convey that in an effective manner. 16 So again, your comments are 17 certainly welcome and appreciated. As you 18 were going around, a couple of things, and 19 maybe this is not for George Allen's list, but 20 a couple of comments I might make in terms of 21 helping us to support your review is there 22 were a couple of comments made where we might Page 161 1 be able to point to where the document 2 actually refers, for example, to the wood 3 smoke in a different chapter. 4 And so one of the things that we 5 have tried very hard to do is to cross 6 reference among the different topical areas 7 that cut across chapters. 8 And so to take a specific example, 9 the wood smoke comment, there is a section in 10 Chapter 4.1 that actually addresses some of 11 those issues of exposure. 12 Perhaps not to the valley point 13 that George was referring to, but I would just 14 like to know if it's helpful to the committee 15 for me to point out a couple of those now, or 16 subsequently? I don't know what's best for 17 you. 18 That's one example where, or the 19 choice study that a couple of you, Cho 20 referred to. Jen actually is a co-author on 21 that paper and it is referred to in the

22 document.202-234-4433 Neal R. Gross & Co., Inc. Page 162 1 But perhaps we can bring that out 2 more as I think a couple of you were 3 suggesting. So, you know, we're wanting to 4 support your review as best as possible. 5 But that's the kind of thing that 6 we can point to certain things in response. 7 And it gets back to maybe the earlier comment 8 of how we're responding to your comments. 9 As we can respond right now, but 10 I'm not sure that's actually what you want. 11 But there are certain things that we can help 12 support your review, and we would welcome your

13 feedback on how to do that best. 14 And then just a minor aside about 15 the color pallette. Okay, my staff know I'm 16 a color challenged person, okay? I don't see 17 red and green very well. And so I've moved 18 towards the blue pallette. 19 But maybe we've gone too far. 20 When we have maps with red and green, I can't 21 see them at all. You know, they just look 22 like a mess, a mush to me. But in any event, Page 163 1 it is again, we appreciate the comments. 2 To the extent that we can help by 3 pointing out certain things, we certainly 4 would welcome the opportunity to do that. 5 DR. HOPKE: I think I might make, 6 maybe a sort of general observation. And I

7 think this follows on Dr. Von Lindern's 8 comment is that I think some panelists, and I 9 don't want to speak for them because they can 10 obviously speak for themselves, but I think

11 there's a concern that the ISA will take on a 12 life of it's own, and in terms of it becomes

13 a reference document for lots of other 14 agencies. 15 And I think there's nothing that 16 can be done to prevent that. On the other 17 hand, the ISA clearly has a context and a 18 scope and a focus that is specifically related 19 to the national ambient air quality standards. 20 And those are kind of opposing or 21 conflicting issues. And I wonder if some of 22 it is just the name of the document, calling Page 164 1 it the Integrated Science Assessment may 2 invite the interpretation that it is, in fact, 3 all encompassing.

4 And I don't know to what extent 5 EPA has thought of this issue or considered

6 even how to name the document so that it is 7 more clearly focused on air related, you know,

8 environmental ambient --

9 DR. HOPKE: You could even call it

10 a criteria document. 11 DR. FREY: Yes, well criteria 12 document means something to us. But anyway, 13 I don't necessarily want to have a long 14 discussion on this, because I think it gets us

15 a little bit off track. 16 But I think it also is a question 17 of interpretation and then that confusion on 18 the interpretation, I think, can lead to 19 comments that are pulling at what is the real

20 focus of the document. 21 I don't know if you have some 22 thoughts or comments you want to make in that Page 165 1 regard. Pardon? 2 DR. VANDENBERG: Real briefly.

3 DR. FREY: Yes. 4 DR. VANDENBERG: No again, we have 5 evolved over time towards this terminology. 6 And what we've tried to do is to bring into 7 the introductory materials in the document 8 what the scope is, what the focus is. 9 The development of an integrative 10 plan with our colleagues in the air offices in 11 attempt to sort of link this to, as you say, 12 link this to the ultimate policy relevance of 13 the document itself and try to give it that 14 context how this maps against or is 15 complimented by the risk and exposure 16 assessment ultimately feeding into the policy

17 assessment. 18 So we're trying to do that and 19 certainly if we're falling short of trying to 20 define that scope, we would welcome any 21 suggestions on how to do that better. 22 But it does carry through multiple202-234-4433 Neal R. Gross & Co., Inc. Page 166 1 documents here, it's not just this one that 2 also, I think serve as a reference for others,

3 too.

4 DR. FREY: Are there other 5 comments or questions? Rich? 6 MR. POIROT: I wanted to add, I 7 forgot to mention earlier that regarding the 8 inventory and the emergence of the aviation 9 fuel as being the single largest category, it

10 occurred to me that there's a difference 11 between being the largest category and being 12 the most important kind of a source. 13 And that it might be helpful, you 14 know, there are 20,000 of these general 15 aviation airports distributed everywhere and 16 only about half of their lead is emitted at 17 that location. The other half is widely

18 disbursed in the ambient air. 19 What about, like, a listing of the 20 largest 20 or X sources of lead and then where 21 would airports show up in that, you know, 22 listing might be helpful as well. Page 167

1 It also occurred to me that 2 anything that you could do to confirm the 3 importance of that source category would be 4 very useful. 5 One example, as I noted, you cited 6 this Dan Murphy paper that looked at all the 7 improved data and looked at the day of week 8 pattern in all of the species measured by 9 improve, and lead was uniquely the only specie 10 measured in this whole network aggregated 11 together that peaked on weekends. 12 And they concluded that this was

13 consistent with the increased recreational use 14 of avgas on weekends. Of course the other 15 thing that we know peaks on weekends is 16 residential wood burning that George mentioned 17 as a potential source. 18 I guess I would be surprised if 19 that actually showed up at the improved sites. 20 But at any rate, anything that you could use 21 to help confirm that. 22 Another example was, I guess in Page 168 1 some places there's studies that show 2 increasing blood lead concentrations as you 3 get closer to airports and that sort of thing. 4 But that was my answer. 5 DR. FREY: Okay, George. I bought 6 you as much time as I could. 7 MR. ALLEN: Gee, thanks. Well, to 8 go through it quickly the first round through. 9 I think what one of the real big take-homes is 10 this issue of Spearman versus Pearson rank 11 order, et cetera, correlations. 12 And whether they're appropriate, 13 when, where, and what the issues are. There 14 is clearly a lot of discussion on that. I'm

15 not sure we have consensus on it. But there

16 was a lot of discussion. 17 I can see both angles there. So

18 there's more work to be done on that. You 19 know, the Cho paper did come up. It is 20 certainly referenced in Chapter 3, whether 21 better use of it could be made, I guess, is 22 the question there. Page 169

1 The basis for having two different 2 FRM's was brought up. The topic of passive 3 samplers, it's an interesting one. You can 4 certainly get detailed spacial intra-urban 5 variability information from there. 6 It's certainly not an FRM. It's 7 more of a diagnostic research kind of thing,

8 but it is out there. 9 (Off microphone comment) 10 MR. ALLEN: Sorry? 11 DR. HOPKE: The Cho, et al. 2011 12 paper's never referenced in Chapter 3. 13 MR. ALLEN: I thought, Cho, C-H-O, 14 no I. It is there, trust me. But yes, the 15 little, take off the I in your comments. C-H-O 16 is the lead author. I believe, is that

17 correct?

18 DR. RICHMOND-BRYANT: Yes. 19 MR. ALLEN: Okay. That's why you 20 couldn't find it. Okay. 21 DR. HOPKE: It's not adequately

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

1 MR. ALLEN: Let's see. The issues 2 of fate and transport defining the PRB 3 question, you know, are the numbers that are 4 there or lack thereof, are they adequate? 5 What might EPA think some better numbers might

6 be? 7 That's a tough one. It's tough in 8 any pollutant, but perhaps tougher in lead. 9 Let's see. Perhaps, you know, a little work 10 being done in terms of fate and transport in 11 the U.S. and you know, there might be issues 12 in taking work done elsewhere and applying it

13 to here.

14 Behavior of lead in soils and 15 water, how do we make progress? That sounds 16 familiar. Kind of like how do I make progress 17 with the FRM sampler?

18 Let's see. Issues of size

19 distribution that that table I've heard from 20 a couple different places that got removed

21 rather than fixed. Sounds like we would 22 prefer that be fixed rather than removed. Page 171 1 Issues with size distribution, are 2 they changing over time and place? The Cho 3 table there might have use. 4 Linking Chapter 4, we already had

5 some discussion of how there seems to be a 6 pretty good, well there is a good linkage 7 between Chapters 3 and 4. 8 And one might argue that they 9 really need to be, to some extent, considered 10 together and that's my job, I think. 11 Linking importance of size versus 12 exposure. That's one of my favorite themes, 13 actually. 14 And if we're going to move forward 15 with changing the size characteristics of an 16 FRM, what implications does that have in terms 17 of both exposure and ultimately blood lead. 18 And that's a very tough question 19 there. The lead log papers on air and soil 20 that were brought up, historical soil lead, 21 perhaps most important in an urban non-source

22 oriented context. Page 172 1 And there's a lot of words there, 2 but they're all important. Seasonality was

3 discussed. Let's see. Potential for Asian 4 transport in background is on the table.

5 The issues of material balance 6 accounting for that. And actually for me, 7 what is maybe most interesting, inventory

8 trends. 9 Those are probably, like many 10 things in trends, it's a moving target over 11 time and if you try to put a trend together

12 with different benchmarks across that time 13 line, you could end up with some odd results. 14 We know that the lead inventory, 15 especially with GA, general aviation aircraft 16 has changed a lot. And unless you deal with 17 those, inventory trends could be difficult.

18 That's what I have. I'm not sure 19 if I missed anything that was important. But 20 if I did, let me know. 21 DR. FREY: Well great. Thanks, 22 George. Well obviously the Chapter 3 Page 173

1 discussants will have opportunities during 2 breaks and this evening to put together a 3 first draft consensus response to the charge 4 questions. 5 And it would also be helpful if 6 you consider what are the top maybe three to 7 five sentences or bullet points or maybe 8 paragraph that goes into the letter to the

9 administrator. 10 I think we're at the point in the 11 agenda for the lunch break. And rather than 12 start the next topic and spend three minutes 13 on it and then take a break, I think we could 14 break early. 15 And we will resume at 1:30 sharp 16 with the discussion on Chapter 4 led by Dr. 17 Goodrum and supported by Dr. Hayes, Dr. 18 Pounds, and Dr. Von Lindern. So we will 19 adjourn until 1:30. Thank you. 20 (Whereupon, the above-entitled

21 matter went off the record at 11:41 a.m. and 22 resumed at 1:30 p.m.)202-234-4433 Neal R. Gross & Co., Inc. Page 174

1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 (1:30 p.m.) 3 DR. FREY: Okay. It's time to 4 begin. I just want to check again if Sean 5 Hays is on the line? Sean are you there? Not 6 yet? Okay. 7 Well we're up to the part of the 8 agenda to review the charge question related 9 to Chapter 4. And Phil Goodrum is the lead 10 discussant. And Sean Hays, Joel Pounds and

11 Ian Von Lindern are the co-discussants.

12 And we'll start with Dr. Goodrum. 13 And if Sean doesn't make it on the line, we'll 14 skip him and then come back as he gets on the 15 line. So, Dr. Goodrum, the floor is yours. 16 DR. GOODRUM: Thanks, Chris. I'd 17 be happy to circle back with Sean as well. 18 That may be Sean right now. Sean?

19 DR. HAYS: Yes. This is Sean. 20 DR. GOODRUM: Okay. Great. 21 Perfect timing. We're just getting started. 22 DR. HAYS: Very good. Page 175

1 DR. GOODRUM: Okay. So I provided 2 some preliminary comments. And then as I was 3 listening today to the presentation, a few 4 other items occurred to me. And I'll try to 5 highlight those. 6 I find myself just as a kind of 7 overall starting point today, thinking about 8 some of the specific goals that were outlined 9 in the planning document. To see, Number 1, 10 if we can tease apart air from other sources 11 of exposure, to the extent that we can. And 12 then to present an uncertainty analysis.

13 To use the information that we 14 have to provide the reader with some context 15 of what the uncertainties are. And therefore, 16 how that might influence some of the policy

17 decisions down the road. 18 So in my notes, for those that 19 didn't focus specifically on Chapter 4, maybe 20 I could just spend a minute highlighting what 21 EPA has already summarized as changes and 22 updates to Chapter 4. Would that be helpful? Page 176 1 Okay. 2 So exposure and toxicokinetics are 3 two groups of changes. And I should probably 4 start by saying that overall as I compared 5 our, you know, consensus comments, and my 6 personal comments, to the changes that I was 7 able to track. I was very pleased. 8 I thought most of the comments

9 that we had were well addressed. And the 10 additions to this chapter, while not 11 extensive, were important and helpful. So 12 I'll try to highlight those. 13 Specifically, there was some

14 additional discussion added on the 15 relationship between air lead and particle 16 size distribution. How those parlay into 17 inhalation versus ingestion, exposure routes, 18 which is a difficult thing to tease apart. 19 And that additional text I thought 20 was very helpful. There was some discussion

21 on measurement errors and uncertainties. And

22 I'll come back to that. Because the Page 177

1 presentation today by Bob Vanderpool was 2 particularly helpful for me. 3 And I'm going to turn to my 4 colleagues and maybe just present a question 5 to them on how to maybe provide a good 6 recommendation for introducing, for capturing 7 those measurement errors and what they mean 8 when we're trying to develop relationships

9 between air lead and blood lead.

10 There was a new section in the 11 exposure side on exposure assessment 12 methodologies. I thought that it did a very 13 nice job of creating a transition between the 14 sections that existed before on exposure 15 assessment, sources of exposure, and then 16 different approaches, empirical modeling 17 approaches. 18 So this was a nice kind of way to 19 introduce the different exposure assessment 20 methodologies. So that was very good. So let 21 me stop there on the exposure side for just a

22 moment.202-234-4433 Neal R. Gross & Co., Inc. Page 178 1 The two questions again in the 2 planning document that I found helpful, and 3 provided some perspective. One goal here with 4 this chapter was to determine if there's 5 enough information that we can disentangle 6 from water and soil related pathways, the 7 contribution of the air related pathways.

8 And then how did the new studies 9 inform the assessment of exposure to these air 10 related pathways? Overall what my take home 11 on this chapter, while the sections do an even 12 better job now of outlining the pluses and 13 minuses of the different studies, and the 14 different exposure methodologies, I found it 15 stopped just short of integrating that 16 information in a way that informed these two 17 questions. 18 I think probably the first 19 question is addressed fairly well. There's 20 some discussion of the challenge and why it's 21 challenging both empirically and with modeling 22 to really truly disentangle new air Page 179

1 contributions from old air contributions, for 2 example. 3 So you're left with the impression 4 that, you know, there are these uncertainties. 5 And you can only expect the different 6 information sources to give you a quantitative

7 estimate so far. 8 But the second piece, how does

9 this information inform our overall

10 assessment? And how do we characterize that 11 uncertainty? I thought could be synthesized

12 a little bit better. 13 And so I presented just one way 14 that I had thought of, and we had talked about 15 as a group last time. And I presented it here 16 again. It's just a series of figures that 17 attempt to take the information on the slopes 18 that is presented both from the empirical 19 study evaluation as well as predicted slopes 20 from the modeling approaches. 21 And put it in a framework that 22 might be a good hand off, if you will, to the Page 180 1 eventual policy decision. So if we think 2 about the fact that we have uncertainty in 3 these slopes, because each study is specific 4 to a community and there's measurement errors

5 and what not. 6 And so there is no one slope, but 7 there's a range of slopes that are important. 8 We need to understand then, what is the 9 contribution of air to the change in blood 10 lead? So that if consequently we are somehow 11 to reduce air as one of the multiple sources, 12 what might we expect as a change in the blood

13 lead. 14 So I need to add to my little 15 graphics here, just to make it absolutely 16 clear, that the Y axis is the change in blood 17 lead, not the absolute blood lead. And 18 focusing on two aspects of the distribution of 19 blood leads in a population. 20 That would be the geometric mean, 21 and then some upper percentile. And I just 22 picked the 95th percentile. And I Page 181

1 characterized this as an example simulation 2 with IEUBK, but really all I did was to borrow 3 the IEUBK approach of relying on the log 4 normal distribution to represent variability.

5 So I did no more than take that 6 slope and interpret what that slope means in 7 terms of a change in the blood lead at either 8 the geometric mean or the 95th percentile. 9 And so these are just a series of 10 graphics that show, not to be proscriptive, 11 but just to show as an example, that as you 12 change from .15 to .1, or some other standard, 13 the change in the blood lead varies between 14 something much less than .5 to about one. 15 Without putting any judgment on, 16 you know, what's recommended, I think this is 17 a good, helpful framework that, it brings it 18 back to the original question, which was now 19 that we understand the relationship between 20 the change in air lead and the change in the 21 blood lead, and what that means as we change

22 our standard.202-234-4433 Neal R. Gross & Co., Inc. Page 182

1 Then we can look at our studies

2 and have a better context to understand those 3 uncertainties. So kind of long winded way of 4 recommending that we revisit the original 5 question. I have -- 6 DR. KOSNETT: Phil, can I ask you 7 this question about that graph? 8 DR. GOODRUM: Okay.

9 DR. KOSNETT: Is that an -- that 10 should be a negative delta, right? If you're 11 going to revise the Y axis? Because it's 12 going from .15 to --

13 DR. GOODRUM: That's true. It's 14 the absolute change in blood lead. But if you 15 wanted to look at the direction, obviously 16 it's going to down.

17 DR. KOSNETT: Yes.

18 DR. GOODRUM: So it would be even 19 more informative to put the slope on it. 20 That's right. 21 DR. KOSNETT: Okay. 22 DR. GOODRUM: But it's just the Page 183 1 absolute change in blood lead at post. I'm 2 not going to reiterate my comments. I think 3 I'll just mention one other item that occurred 4 to me. And this is the question part for my 5 colleagues. 6 So I was thinking about, well two 7 items. One is, there's a statement on Page 4- 8 122 that's repeated in the integrated study on 9 Page 214. That is in a paragraph that talks 10 about an uncertainty, a limitation really of

11 models. 12 And even of empirical data, which 13 is that, you know, in a dynamic system where 14 we would expect there to be oscillations, is 15 the term used here, in the peaks and valleys 16 in blood leads and empirical data, are getting 17 snap shots. 18 We can't expect that the empirical 19 data necessarily is going to capture the peaks 20 and valleys and the exposure. It's a 21 integrated, kind of cumulative metric. 22 And so the statement is, high Page 184 1 variability in blood lead in blood exposures 2 can produce episodic oscillations in blood 3 lead concentration that may not be captured 4 with low sampling frequencies. 5 And I think what's really meant 6 there is that the intent isn't to capture

7 those oscillations. The intent is to 8 accurately represent some long term average

9 blood lead. 10 And so really the question is, 11 given that we have discreet points in this 12 distribution that oscillates, and every 13 individual, let's say, is a random point on 14 that oscillation. The real question is, 15 collectively, do our blood leads give us a

16 measure that's unbiased? 17 So I would reframe that to say 18 that, you know, we're interested in 19 understanding from the data or from the models 20 what the slope is on that relationship. Not 21 to represent the immediate time course, but 22 what the actual long term average slope is. Page 185 1 What that relationship is between average, you 2 know, exposures and blood leads. 3 I think that's important because 4 it gets into these questions of, you know, is 5 it critical that we reproduce individual life 6 histories or is it more important that the 7 estimates that we derive are protective of 8 populations, and high ends on those 9 populations, high end exposures on those 10 populations? I think I'll stop there. 11 DR. FREY: Thanks, Phil. I just 12 wanted to point out, we finally found your 13 graph and it's up on the screen. 14 DR. GOODRUM: Okay. Thanks. 15 DR. FREY: So if anyone wants

16 refer to that. And it's in the additional 17 preliminary comments, the second set of 18 comments that were sent out by Aaron, on Page 19 9, I believe, if you want to refer to that. 20 MR. HANLON: And they're also up 21 on our website, the meeting website. 22 DR. FREY: Okay. Sean, are you202-234-4433 Neal R. Gross & Co., Inc. Page 186 1 ready to share your comments on Chapter 4?

2 DR. HAYS: Sure. 3 DR. FREY: Okay. 4 DR. HAYS: You bet. So I thought 5 EPA was very responsive to addressing the 6 comments that we had on Chapter 4. So I

7 commend them for that.

8 The two main concerns that I had 9 with the previous document that we reviewed,

10 was that the lack of discussion about the 11 relative sources of exposure and pathways, and

12 their contribution towards blood lead

13 concentrations. 14 They've added a section that 15 presents the IEUBK model results for 16 addressing this kind of apportionment issue. 17 And while that's one way of approaching it, 18 you know, it would be nice to have some data. 19 I assume in the future exposure and risk 20 assessment they'll expand on this. So I'm 21 assuming you'll expand on that even more. 22 The other concept that I had an Page 187 1 issue with in the first version, was the air 2 to blood lead correlations, or slope factors. 3 And they've done a very good job of adding 4 more transparency with respect to those. 5 Table 411 and Figure 422 are very helpful. 6 The thing that's very striking to 7 me is the lack of data, or lack of slope

8 factors for the air concentrations of interest 9 for the NAAQS. And potentially lower air 10 exposure levels. There's a few that barely 11 overlap the NAAQS, and a little bit lower. 12 And some of those, especially the 13 log log models really diverge at the low air 14 exposure levels. So it will be interesting 15 and important for EPA to provide an opinion on 16 which correlations will be most applicable for 17 a risk assessment, at or below the current 18 NAAQS. 19 And I think the modeling that Phil 20 presented would be a very nice addition to the 21 exposure and risk assessment report. And to 22 be able to compare and contrast the two, the Page 188 1 IEUBK and the slope factors. Especially at 2 those low air concentrations, to get a better 3 handle on which models are most applicable.

4 And that's all the comments I had. 5 DR. FREY: Okay. Thank you, Sean.

6 Dr. Joel Pounds. 7 DR. POUNDS: Thank you. I concur 8 that the Chapter 4 was certainly more complete 9 and more transparent from the previous 10 version. In fact, in most places it was 11 really a pleasure to read. 12 A couple of general comments. And 13 that is, for example, Section 4.1, each 14 paragraph lucidly describes the data and the 15 conclusions from the papers. 16 But unlike Section 4.2, the 17 paragraphs really didn't end with any summary 18 or evaluation of the data, and tell the reader 19 what we were supposed to get out of those 20 particular papers or what those data meant in

21 the context of the ISA. 22 And I think that to go back and Page 189 1 revisit, especially Section 4.1, to try to add 2 a little bit of interpretation would really 3 improve the transparency of the document. 4 Again, I think because I really 5 did like the revised chapter, I feel that some 6 of these are kind of nit picking. And I'm not 7 going to go over very many of my comments. 8 One thing, I think that if the 9 notes for the figures could include the 10 figures that involve simulations. If they 11 could provide some of the important input 12 information to the model, that would help 13 those of us who care about such things 14 interpret the models. 15 And for example, you know, when 16 there's changes in blood lead, what was the 17 lead input to the model as it changed over

18 time? 19 Second sort of related questions 20 was that I was unclear why some of the figures 21 used time averaging of urine lead or blood 22 lead. So time averaging is used to, you know,202-234-4433 Neal R. Gross & Co., Inc. Page 190 1 decrease the variability of your data. And 2 perhaps the air, when time averaging is used 3 with ICRP data, you know, simulated data, 4 there are no experimental error as such. 5 And so it seems like including 6 those time averaged data kind of distract from 7 the message of the chapter, without providing 8 anything substantive in return for the space. 9 And then I provided several 10 examples of sentences that I didn't really 11 agree with. And I've tried to explain why. 12 And I think most places it's a matter of 13 clarity. 14 But I did find a few places, for 15 example, on Page 39 it says that the body 16 burden of lead in blood is one percent. And 17 on Page 49 it's five percent. And on Page 15, 18 and Page 54, I'm sorry, 49 and 54, it says 19 that the major lead binding component in blood 20 is either hemoglobin or ALAD, depending on 21 which page you read. 22 So, I mean, these statements are Page 191 1 really directly in contradiction with each 2 other. And in fact, when I looked at an 3 apparent contradiction with some of the text 4 on erythrocyte binding proteins in Chapter 5, 5 which were, different figures were given, but

6 kind of a little bit different discussion. 7 So it wasn't easy to tell if they 8 were apples and oranges or Granny Smith's, and 9 Delicious apples that were being compared. 10 But this chapter was quite useful I think in 11 the context of the ISA. And it was a joy to

12 read. 13 DR. FREY: Okay. Thanks. Dr. Von

14 Lindern. 15 DR. VON LINDERN: Excuse me. Yes, 16 I concur with my colleagues' statements here. 17 Before I thought this was, I thought it was 18 pretty good to begin with. And it was 19 improved. 20 However, I could be more enthused 21 about it if it was a prelude to a risk 22 assessment. But because we're not going to Page 192 1 have any risk assessment, it really is a 2 presentation about historical information, and 3 the potential measures by which we might 4 pursue a risk assessment, were we to have the

5 data to do one. 6 So that goes back to my earlier

7 comment that most of this is based on decades 8 old data and relationships. Now, and some 9 folks have pointed out the difficulty of 10 taking those relationships down into the 11 exposure levels of the current NAAQS.

12 I did feel a little bit better 13 this morning, after the folks talked about the 14 work that is ongoing to do some additional 15 monitoring. And do monitoring that is 16 pertinent to the atmospheric levels that are

17 of concern here. 18 I think maybe next time, five 19 years from now, when there are some more data, 20 it might be exciting again. Because evidently 21 the air lead values that we've been seeing all 22 these years weren't all that accurate. Page 193

1 So if you really dissect out a 2 decision making was made with respect to this 3 NAAQS. It's based on the air lead, blood lead 4 relationship. And it seems like we might be 5 upsetting the way we measure air lead. 6 So we're going to have to go back

7 and re-look at how blood lead relates to that. 8 In that case, and folks have noted here 9 before, that there's lots of other routes of 10 exposure as well. 11 So all of those relationships are

12 teased out within those other routes of 13 exposures. And those have changed 14 dramatically in the United States over the 15 years.

16 So what is the relative

17 contribution from these different sources? 18 We're probably not as certain about that as we 19 think we were when we were looking in that 20 window of a decade or two ago. 21 And then the last thought is, I 22 always try now to caveat all of these202-234-4433 Neal R. Gross & Co., Inc. Page 194 1 relationships as the United States, Europe and

2 Australia. Because the rest of the world is 3 out there and has far different exposure 4 scenarios that they're dealing with. 5 And as we begin to explore those 6 we're going to see a lot of what we have 7 presumed to be mechanistic, maybe really is,

8 has a lot more of these variable factors

9 involved in it.

10 And then I had one last minor 11 point. And that's in the historic description

12 of the successes that we've had in the 13 country. That's a bit gasoline centric in my

14 view.

15 There were a lot of other air lead 16 sources that were dramatically reduced over 17 the years. And it would be good to have the

18 record reflect that as well. Thanks. 19 DR. FREY: Great. Thank you. At 20 this time I'll open up the commenting to any 21 member of the panel. And I guess, Phil, you'd

22 like to follow on. Page 195

1 DR. GOODRUM: Yes. Joel reminded 2 me, and Ian just led into it nicely, that 3 there is one other topic that I neglected to 4 mention, but will just put on the table. And 5 that is, given the measurement errors that we 6 understand, I understand better now from this 7 morning. 8 What impact then does that have on 9 our ability to estimate these load factors? 10 If the bias was systematic, in other words, 11 the lead and TSP was systematically 12 underestimated, it seems to me that the slope 13 factor, that relationship between change in 14 lead and change in blood lead, change in air 15 lead and change in blood lead wouldn't be as 16 affected as any absolute prediction of blood 17 lead, or ration models, or what have you, that 18 are trying to include air in one of the 19 explanatory variables. 20 So you might get the intercept 21 wrong, let's say, on a linear regression, just 22 to keep it simple. But the slope might be Page 196 1 right. So that's just a question to kind of 2 pose to the group. 3 It is, we have two aspects of 4 uncertainty. One is the uncertainty in the 5 relationship between air lead and blood lead, 6 as reflected by the slopes. And then the 7 other is the ability to understand the

8 relative contribution of air to an absolute

9 estimate of blood lead. 10 And that percent contribution of 11 air, which might be reflected by, you know, 12 certain data sets for U.S., Europe, and

13 Australia could be a different relative

14 contribution than for other communities. And 15 the data might bear that out.

16 So there's a difference between 17 how the uncertainty might impact the slope, 18 versus any absolute estimate. That's just a 19 follow on thought that we'll try to capture. 20 DR. FREY: Okay. Comments? Yes,

21 Michael. 22 DR. KOSNETT: I hadn't yet had a Page 197 1 chance to review Chapter 4 in detail. But 2 there were a few things that I had hoped the 3 document would reflect to a greater degree, 4 based on our previous topics. And I'm just 5 going to bring up three of them. 6 One is, we had in our report that 7 was finalized in December, we had asked that 8 EPA consider in this document putting in 9 better perspective. The relative contribution 10 of lead from air, to lead from other pathways. 11 Including diet and water. 12 And there was, it seemed to me 13 that there was an attempt to do that on Page 14 4-6, which if you look at the bottom of Page 15 4-6. I don't know if you could put that up. 16 But it's basically a narrative 17 explanation of a study based on EPA 2007, that 18 essentially says that inhalation air is about 19 zero to five, 0.5 to .06 percent. Ingestion 20 of recent lead is about 12 to 28 percent. And 21 then presumably the remainder that we get is 22 diet, which is the largest part. And then202-234-4433 Neal R. Gross & Co., Inc. Page 198 1 combining diet with water. And then dust. 2 And I thought it would be -- I 3 think that's kind of interesting in a document 4 like this to put in perspective how, you know, 5 the average American has a blood lead of one 6 and a half micrograms per deciliter today.

7 If we were to eliminate all the 8 air lead, that wouldn't change. Their blood 9 leads wouldn't change very much. Because 10 most of it is not recent lead in air, or 11 inhaled lead. You know, ingested lead from

12 recent lead. 13 And so I thought a table, or some 14 kind of graphical depiction of the relative 15 source contributions would really be helpful

16 to have in this document. 17 In fact, I think if we go back on, 18 if you go back to our report comments, our 19 consensus comments, we asked for that. But 20 with all due respect to the fact that this 21 half page paragraph was put in at the bottom 22 of, where this paragraph was put in at the Page 199 1 bottom of 4-6. I think that's the only 2 attempt.

3 And I don't think it was -- No 4 that's not, that's Table 4.6. I'm talking 5 about Page 4-6. So, and I think, Phil, you 6 and I were talking off line. Is that fair?

7 Is that a fair comment?

8 DR. GOODRUM: Yes. I think it is. 9 And, you know, most of what I think is 10 presented there is the model predictions of

11 what those relative contributions are. But we 12 could, you know, ask that that be presented to 13 the extent possible from the, you know, what 14 the empirical data bear out as well.

15 DR. KOSNETT: Yes. So I think it 16 would be really helpful. Because when you 17 actually think about it, air is a very simple 18 contribution. And, you know, why is it 19 important?

20 Well one of the reasons it's 21 important is that we as a society, and we've

22 had blood leads now about 1.5. We want to Page 200 1 avoid children at the higher end certainly, 2 getting exposure. 3 But say we wanted to shift our 4 entire population. Say it was a desirable 5 public health goal to go from a blood lead of 6 1.5 to .5 over the next 20 years. Because we

7 know that there's still adverse affects at 8 1.5. How would we get there? 9 Well this document could help us 10 with some of the scientific foundation by 11 showing us where we think the lead is coming

12 from. 13 So I think it would be a helpful 14 contribution to the literature, and to 15 understanding regulating lead overall, to have

16 a little more discussion about it. And a 17 graph or table or something, pie chart, or 18 whatever, would be really helpful. Okay. 19 Then another concern I had was, we

20 had made a comment in our consensus comments 21 last time, about the rate of change of blood 22 lead after you terminate exposure. If you Page 201 1 could turn to Page 4-67? If you could put 2 that up? Oh, no. Do I mean -- Hold on. Yes, 3 well Page 4-67.

4 And there is a statement. And 5 it's talking about the modeling of blood lead 6 after you change exposure. And it says 7 basically -- 8 DR. FREY: Could you just mention

9 the line number?

10 DR. KOSNETT: The line number? 11 DR. FREY: Yes. That would help. 12 DR. KOSNETT: Line 12, Page 4-67. 13 And then it's -- Okay, you're not putting it 14 up? Or you are putting it up? All right,

15 Line 12. It talks about simulation. 16 And it says, based on this 17 hypothetical simulation, a blood lead 18 concentration measured one year following 19 cessation of a period of increased lead 20 uptake, which showed little or no appreciable 21 change from prior to the exposure event. 22 Whereas, body burden would remain elevated.202-234-4433 Neal R. Gross & Co., Inc. Page 202 1 And could you turn to the next 2 page, please? See there's a graph there. And 3 do you see that graph? It shows somebody 4 having 20 years of lead exposure that elevates 5 their blood lead four-fold. Okay. So it's a 6 300 percent increase in blood lead. 7 And then it says you stop the 8 exposure after 20 years, and within a year 9 your blood lead goes back down like it never 10 happened. 11 Now we raised specific comments at 12 the bottom of Page 86 of our A-6, of our

13 comments in December. This is the consensus 14 comments. These are mine personally. But

15 these are also consensus comments. 16 That there's something wrong with 17 the real world validity of that modeling, with 18 all due respect to the legate model. Because 19 there are features of the legate model which 20 say that lead can exchange from bone, only in 21 a certain exchangeable compartments. And not

22 across all of bone matrix. Page 203

1 Whereas the O'Flaherty model would 2 say that it's a different model. It says that 3 lead can diffuse out of bone, and not just in 4 specific compartments. 5 Now I can tell you from my own 6 experience in occupational lead poisoning and 7 dealing with people in the workplace. If you 8 have someone who had a 300 percent increase in 9 their blood lead by working in a factory for 10 20 years, and you removed them from exposure,

11 their blood lead does not return to baseline 12 in one year. It just does not, okay.

13 And I think we asked for a 14 discussion. And we specifically cited this 15 question. And there's been no change

16 whatsoever in the document to reflect that 17 concern. And I want to ask EPA, why not? 18 DR. VANDENBERG: Could we respond? 19 DR. BROWN: I would just say, if 20 you could turn to Page 462, Line 5? We did 21 add in most of a new paragraph there actually. 22 Discussing the slow decline in the blood leads Page 204 1 in the occupational setting. As well as 2 mentioning -- Well there was already one 3 children's study in there that was mentioned. 4 DR. KOSNETT: Right. But why do 5 you have that other sentence in there, and 6 those simulations without mentioning there

7 that those simulations -- there is doubt on 8 the validity of these simulations, and that 9 other modeling approaches might not replicate

10 them. 11 I think, and maybe, Joel, you 12 might feel differently. Joel's an expert in 13 this. But I just think it gives the wrong 14 impression to people looking and interpreting 15 blood leads, to think that after a year your 16 blood lead goes down. 17 It just always -- That may be the 18 case for certain exposures and certain 19 magnitudes of exposures. But it's not the 20 case, it's not universally the case. And I 21 would still make a request that the nuances of 22 this be discussed better. Joel, do you have Page 205

1 a comment?

2 DR. POUNDS: A little bit. I 3 mean, I understand your concern. But the 4 simulation in Figure 4.11 is for children. It 5 only gives a blood lead of about nine. And 6 you were trying much of your argument from 7 your experience with occupational exposure -- 8 DR. KOSNETT: But Joel, it's not - 9 - I'm sorry, it's not children if we're 10 looking at the same one. 11 DR. POUNDS: I'm sorry, it's not 12 children. It's just a blood lead level of 13 less than ten. It's not the kind of, what I 14 assume that you have in terms of occupational 15 exposure. You know, long term occupational 16 exposure, such as David has. 17 Blood leads don't return nearly as 18 quickly as these do with cessation of 19 exposure. And you know they have that in some 20 of their studies. Because they had strikes

21 that went out. 22 DR. KOSNETT: Right.202-234-4433 Neal R. Gross & Co., Inc. Page 206

1 DR. POUNDS: But I think it's not 2 wise to extrapolate from a simulation that 3 goes up to nine micrograms, to something that 4 goes, you know, three or four times higher 5 than that. Because your body burden is going 6 to be a lot higher than three or four times

7 that. 8 DR. KOSNETT: And it may be true, 9 that there may be a relatively quicker change 10 going from a 300 percent increase from two to 11 eight, as opposed to 20 to 80. But I think 12 the basic principles of exchange of lead from 13 the compartments are still scale.

14 At least I have not seen evidence 15 to indicate that the exchange, the rate of 16 bone turnover changes appreciably if somebody 17 had a, when blood lead goes from eight to 25, 18 let's say. 19 I think, I mean, certainly there's

20 some effects on osteoclastic function. But I 21 think essentially the bone metabolism stays

22 similar. So I still think the rate at which Page 207

1 lead is released would mirror it.

2 And I don't think it would decline 3 so much faster going from eight to two as it 4 would from -- At least, this is a model.

5 Remember this is a model. This isn't real

6 data.

7 And so I have concerns about the 8 validity of this model, based on -- Yes, most 9 of my experience is to show you a higher 10 exposure. But I think the principles of bone 11 metabolism is still applicable. 12 And then I would say that the

13 burden is on the modelers to show that there's

14 differences in bone metabolism that would 15 predict that it would fall much faster, than 16 it would at a higher -- 17 DR. POUNDS: So your concern is 18 with the, if you will, the T-1 half of the 19 change in blood lead. 20 DR. KOSNETT: You're basically 21 changing the half life of lead in blood after 22 20 years. So that's a long term compartment. Page 208

1 DR. POUNDS: Yes. So that one of 2 the questions that I had in my comments was 3 about asking for more information in the 4 simulations. So we don't know what, as we're 5 discussing this, we don't know what the input

6 to the model was. 7 And before it went up, right, for 8 that duration of time. And did it come, did 9 lead input come down to zero, which is 10 something that can't occur, you know, even in 11 Michael's dreams, right. Or did it come down 12 to some baseline? So we just don't know that. 13 And that might help us interpret 14 some of these data a little better. Yes, I 15 think although, that Ellen O'Flaherty's PPBK 16 model and legates about kinetic model are 17 mathematically different, and structurally 18 different. To the degree that I've played 19 with Ellen's model, I think they give very 20 comparable outcomes. 21 You know, model simulations and, 22 you know, the models were developed, both of Page 209 1 them really, all of them, to predict blood 2 leads. They weren't developed to predict bone

3 leads -- 4 DR. KOSNETT: Right. 5 DR. POUNDS: -- or tissue leads, 6 right. That was just some of the things that 7 had to be done in order to predict the blood

8 leads. 9 DR. KOSNETT: All right. Well --

10 DR. POUNDS: So as far as I'm

11 concerned -- 12 DR. FREY: I'm just looking at the 13 clock. And we're running into the time for 14 discussion of other charge questions. So I 15 wonder, just to summarize what's been

16 discussed.

17 I think what I've heard is some 18 concern about the fidelity of the predictions 19 implied by the graphs in Figure 4-11. And 20 maybe one approach to that is to clearly label 21 that these are example scenarios based on 22 particular parameter values.202-234-4433 Neal R. Gross & Co., Inc. Page 210 1 And that empirical data may 2 suggest that, or experience may suggest that 3 the decay and the blood lead concentration may 4 not follow this time path. And that there 5 maybe is more interaction between bone and 6 lead than is implied by the model after the 7 air exposure ends. But I'm wondering if we 8 can kind of wrap this up -- 9 DR. KOSNETT: Okay. That's fine. 10 But you can understand too, that has broad 11 implications -- 12 DR. FREY: Oh, absolutely.

13 DR. KOSNETT: -- for risk 14 assessment and superfund sites and other 15 things like that. And people, if you're 16 basically told that, you know, once you've 17 moved away from that site, if your blood lead 18 is still high then it had to be, you can't, 19 you know, it had to be due to some exposure 20 you have now. 21 Because your blood lead's supposed 22 to go down to where it was after a year. I Page 211 1 mean, this has broad implications for risk 2 management and risk assessment. 3 DR. FREY: But I'm just thinking, 4 maybe some of the detail here could be 5 discussed by the group -- 6 DR. KOSNETT: Okay. 7 DR. FREY: -- in writing the 8 response to the charge questions. And, 9 Michael, you are certainly welcome to

10 contribute to that. 11 DR. KOSNETT: Yes, I will. And -- 12 DR. FREY: And I think the point, 13 and it may be a general point too, is that, 14 you know, I think this is another example 15 where panelists are concerned that the 16 revision wasn't really responsive to the

17 comment. 18 And I think in part it was. But 19 it was in text a few pages before. And then 20 the figure is kind of a lightning rod for the 21 concern. And the discussion of the figure and 22 the documentation of the figure itself doesn't Page 212 1 quite address the concern of the panel.

2 So I think there is a need to be a 3 little more thorough in addressing the prior

4 concern and then the concern iterated here. 5 And I agree with you. This clearly has 6 important implications for risk assessment. 7 Having said that, I wonder if we can --

8 DR. KOSNETT: I have one -- 9 DR. FREY: I will get to you, just 10 a second. Just try to wrap up on Chapter 4.

11 DR. KOSNETT: I have one more and 12 I won't take long. 13 DR. FREY: Okay. All right. And 14 then Dr. Rabinowitz has been patient. So -- 15 DR. KOSNETT: Okay. The other 16 thing is it has to do with the slopes and the 17 tables of the slopes. Like Table 4-10, and 18 actually Table 4-10 I think is repeated in

19 Section 2. Excuse me Table 4-11. We have all 20 these different slopes -- I'm sorry, 4-102.

21 There's all these -- 22 DR. FREY: Wait, 4-102 is a page? Page 213 1 DR. KOSNETT: Page 4-102, Table 4- 2 11. And it sets forth a bunch of blood lead, 3 air lead slopes. And then there's discussion 4 in the narrative that these slopes range from, 5 you know one to nine. And that some of them 6 have log log relationships, some of them have 7 linear relationships. 8 But the thing that we asked for, 9 and again going back to our comments from 10 December is, we said to EPA, can you discuss 11 for us, given this broad range, which ones do 12 you consider to have the most validity and 13 utility for risk assessment? That was one of 14 our specific comments. 15 DR. FREY: I forgot the page. 16 DR. KOSNETT: And, you know, with 17 all due respect, I don't think that has been

18 addressed.

19 DR. VANDENBERG: And that comment 20 kind of intersects with what Sean was picking 21 up on, Figure 4-22, which does a nice job of 22 presenting that information graphically.202-234-4433 Neal R. Gross & Co., Inc. Page 214 1 But there's, you know, uncertainty 2 in terms of the low end. And it might be 3 helpful to include some text that speaks to, 4 you know, how to address that uncertainty and

5 inferences at the low end.

6 DR. KOSNETT: Which one is better? 7 And, you know, even in the summary on Page 4- 8 123, there's a summary of it. And it says

9 that there's different ones. But it doesn't 10 give a critical evaluation of which one is 11 more, has the greatest utility. And which one

12 we should use. 13 And we asked for that, and it's 14 not there. And I know it's hard. I mean, I'm 15 not saying it's easy to necessarily take all

16 these different studies. 17 But this is something that I hope 18 we would get out of a document like this. And 19 so I think I'd like to reiterate the request 20 that that be done. Okay. I'm done. 21 DR. FREY: Good. Thank you. I 22 almost hesitate to ask, but I guess if anyone Page 215 1 has a recommendation for what might be the 2 most useful studies, it might be helpful to 3 EPA to share that in your comments. But let 4 me give the floor to Dr. Rabinowitz. 5 DR. RABINOWITZ: Thank you. I'm 6 sorry if I'm repeating a few things. But it 7 seems to me that you have two things going on 8 at once in this chapter. 9 On the one hand, we really knows 10 what goes on with blood lead. We know that if 11 you had a long period of exposure it decays 12 more slowly. Dirocheck did a lot of work with 13 this in occupational setting. We've seen it 14 in children too. So we know what really goes

15 on.

16 And then we have these models that 17 are shown, chosen by the authors of the 18 document for some didactic purpose. They want 19 to make some point. 20 And I just think as long as we 21 keep these two separate, know what really goes

22 on. And the simulation models that are used Page 216 1 just for some explanatory purpose. Perhaps, 2 Chris, using the foot notes you suggested, I 3 think we'll escape that problem. 4 Turning to a different topic, 5 okay. Just a question. On Page 437, there's 6 a little something that kind of caught my eye. 7 There's a figure there on Page 437. I just 8 have this fear that some little error creeped 9 in and is just going to stay in until we

10 address it. 11 And there's that graph. And 12 there's lead phosphate. I can't believe lead 13 phosphate's so high. But I've been wrong so 14 many times. Can somebody just go back and 15 make sure that's really -- 16 Because lead phosphate is the 17 least soluble form of lead. It's solubility

18 factor is like ten to the minus 36 or 19 something. Now maybe it really is like it's 20 reported here. But just check it, okay?

21 That's all.

22 You had that wonderful table Page 217 1 showing all the air lead, blood lead slopes in 2 your certain studies. And I have some

3 comments. When our turn comes later this 4 afternoon, some of these things do reappear in 5 Chapters 1 and 2. Should I address it now? 6 DR. FREY: I'm going to leave that 7 to your judgment. 8 DR. RABINOWITZ: Okay. Well I'll 9 do it now. I'll just read my comments, which 10 were originally designed to go into Chapter 1. 11 But they fit here, because this is where the 12 table is that shows up in Table 1. 13 And you have all these lists of 14 slopes. This is all nice, big scatter. And 15 I said to myself, gee I've measured this value 16 twice in my life with different populations. 17 So in my notes to you I've just kind of 18 rearranged my data to fit your template, to 19 see how the slopes would compare. 20 And the results are there for you 21 to see. Whether or not you want to include it 22 in the document, I'll leave for your judgment.202-234-4433 Neal R. Gross & Co., Inc. Page 218 1 But for myself, since I measured it twice and 2 wound up with numbers like four and nine for

3 adults and children.

4 And it's kind of within an order 5 of magnitude of these other ones. Yes, it's 6 all fine. If you're willing to accept it's 7 all fine within an order of, factor of two 8 uncertainty. 9 If you're willing to accept that 10 size of uncertainty, I'll just swallow it 11 whole. If you want to include these other 12 studies, that's fine. My mother would like 13 that. That's it for now, thank you. 14 DR. FREY: Okay. Thank you. Dr.

15 Pounds. 16 DR. POUNDS: I'm sorry, real 17 quick. So the presentation we heard this 18 morning that showed particle size dependent 19 underestimation of air leads, you know, which 20 I did not appreciate. Makes me really suspect 21 all the slope relationships. 22 And so from all of these data, I Page 219 1 don't know which of them to trust, right. And 2 I assume that somebody who recognizes this 3 issue has looked over that. But, you know, 4 Phil raised the issue, but I haven't heard any 5 discussion to give me any comfort that we can 6 trust these slopes.

7 DR. RABINOWITZ: Well how much do 8 you want to trust it? Does that mean right 9 within ten percent? I mean, what do you want? 10 DR. FREY: Well I know George, and

11 then Dr. Von Lindern are next. 12 MR. ALLEN: I guess I'd probably 13 say, don't worry about that. Although we do 14 certainly not like the FRM. Overall in the 15 bigger picture it's probably not going to 16 change the kind of data we're talking about by 17 more than ten, 20, 25 percent. 18 And given all the other 19 uncertainties in the process I don't think 20 it's a player. So I wouldn't let that keep 21 you up at night. I mean, there are issues 22 with the sampler, but it's in a different Page 220 1 perspective.

2 DR. POUNDS: Well that's 3 comforting.

4 DR. VON LINDERN: I also have a 5 suggestion for that table in the next chapter. 6 So I'll get it out here. Really you've 7 already done it. You've already twice said 8 which ones you believe in. 9 Because you've adopted two 10 standards. And in those standards you cited 11 particular studies that you relied upon to 12 pick the air lead, blood lead slope. So

13 that's not reflected in those tables. 14 And in fact, the Brunekreef is 15 kind of the second stage of history. Because 16 the standard was adopted a few years before 17 that and cited three specific studies for the 18 air lead, blood lead slope. Those are

19 reviewed in that Brunekreef article later on. 20 But the agency is already on 21 record in having adopted the standards as to 22 which ones they relied upon. And it would be Page 221 1 good for the history to reflect that.

2 DR. FREY: Yes. Dr. Canfield. 3 DR. CANFIELD: I just wanted to 4 make sure I understood what George was saying 5 here about, comforting us about the errors in 6 the sampler.

7 So we don't know the flow rates

8 and the variation in the flow rates in the 9 samplers that are out there? We don't know

10 the size and the variation in size? And we 11 don't know if they're getting the particles 12 that they were designed to get? And then 13 there's wind speed and direction and all those 14 kind of things. 15 I mean, those are a lot of sources 16 of uncertainty. If they all cancel out, well 17 that's fine. But is there, am I 18 characterizing the sources of airs correctly? 19 Or maybe not? 20 MR. ALLEN: Well yes and no. They 21 don't cancel out. That's not what I'm trying 22 to say. The errors for any one given202-234-4433 Neal R. Gross & Co., Inc. Page 222 1 measurement site, compared to what we think 2 they might be, might be 50 percent on a bad 3 day. Or maybe a factor or two on a bad day. 4 But when you take all the data. 5 We're talking about a lot of exposure data 6 here, lots of samplers, lots of sites, and 7 kind of dump them all in the same pot, which 8 is kind of what we're doing, most of it's 9 okay. 10 It's not a -- Phil's nodding his 11 head. Oh, good. It's not great, but it's not 12 really going to change the relationships that 13 we're talking about here. 14 DR. HOPKE: Given the variability

15 and the actual transfer from concentrations to 16 exposure dose. And then the differences in 17 the biological processes, this is a source of 18 error that it would be good to clean up. But 19 it's not driving the whole process. 20 MR. ALLEN: Right. Thanks Bob. 21 DR. FREY: Yes, Rich.

22 MR. POIROT: I would like to sort Page 223

1 of come down a little bit on the other side of 2 that, which is to suggest that if you're

3 concerned about this blood lead to air lead 4 ratio, having been affected by under sampling 5 of lead by TSP samplers. 6 If you collected more lead that's 7 just going to make the ratio smaller. There's

8 more lead out there in the air at some time 9 than the TSP samplers collect. 10 But it's in really, really large 11 particle sizes. And progressively less is 12 missed as you get down to the smaller. All of 13 the smaller stuff is captured.

14 But I kind of wanted to raise the 15 opposite point, which is that again in this 16 exposure chapter there's relatively little 17 information. And I suspect that's because 18 there's none in the literature, or little 19 about how particle size affects first of all

20 the transfer of air lead to surfaces from 21 which it can be taken up.

22 And then how once it's on the Page 224 1 surfaces and you get it on your hand, you 2 know, how much is taken up by hand to mouth 3 action. How does particle size affect that? 4 And then third, once it is 5 ingested, how does the particle size affect 6 the percent absorption, which is confounded by 7 the difference in chemical composition of lead 8 and different particle sizes, with the general 9 idea at least proposed in Chapter 3?

10 That the smaller the size 11 particles are, the more soluble they are. All 12 of those things all push in one direction. 13 And nothing pushes in the other direction, 14 that says, coarse particles are more 15 important, or even as important a way to get 16 your dose of lead. So I just, I did want 17 emphasize that. 18 I also just wanted to make the 19 observation that in the one instance where you 20 do cite some differences in particle sizes of 21 how lead is picked up by the hands. There are 22 two studies. And the results are maddeningly Page 225 1 disparate with the one study, the older one, 2 showing it's virtually all less than ten

3 microns. 4 And the newer one saying the mode 5 of the particle size is 40 microns, plus or 6 minus 25. So it's, that's night and day.

7 That makes a lot of difference in terms of air

8 lead and reflects back on how should we

9 measure it to feed back better into how it's 10 ultimately taken up. 11 DR. FREY: Okay. One or two more 12 questions on Chapter 4? Comments? Okay. 13 Great. Phil, I think I'm not going to put you 14 on the spot to summarize right now. 15 But I might put you on the spot 16 either at the end of today or the beginning of 17 tomorrow. So I'll give you a little bit of 18 time. Because I think there's a lot to digest 19 here. Okay. 20 Well let's move on to Chapter 5, 21 which I'm sure we'll have a very brief, quick

22 discussion of. Frank? And the lead202-234-4433 Neal R. Gross & Co., Inc. Page 226

1 discussant is Dr. Korrick. And co-discussants 2 are Dr. Canfield, Cory-Slechta, Kosnett and

3 Wasserman. All of whom are reticent to share 4 their opinions. Okay, Dr. Korrick. 5 DR. KORRICK: Okay. So Chapter 5 6 is I think generally very much improved over 7 the previous draft. And I think that ways in 8 which it's been improved include I think in 9 general it looks at consistency in the 10 literature on a given health in point much 11 more comprehensively than it did originally. 12 That there's very consistent 13 acknowledgment of limitations of current blood 14 lead and capturing relevant exposures in 15 adults and older kids, which was an important 16 point from our previous comments.

17 That it's much clearer on sort of 18 setting the standard for what was known as of 19 the 2006 document and then building on that, 20 which has a nice sort of organizational flow

21 to it.

22 And that there's much better Page 227 1 addressing of the use of, or more explicitly 2 explaining homologous or process related 3 outcomes in animal as compared to human

4 studies. 5 And also acknowledging the role of 6 dosing in animal studies in determining 7 comparability with human studies. Not only 8 for dose response issues, but obviously for

9 mechanistic issues. So I think that those are 10 some of the major concerns that we had in our 11 original review. 12 And I think every single one of

13 them has been addressed to some extent in 14 Chapter 5. And it's a big improvement. But 15 I think that apropos of discussions we had 16 before the break, I think that there are some 17 areas that were not addressed, or were 18 addressed incompletely.

19 And it's hard to know if that was

20 a conscious choice or an omission. And I

21 think some of the areas that were not 22 addressed as completely as I would like, and Page 228 1 I appreciate that my colleagues in this review 2 may disagree, is that I think there's an -- 3 Just as a backup a little bit. 4 There's an incredibly rich literature on the 5 health effects of lead. I mean, there are 6 almost no other contaminants for which so many 7 studies have been performed. And so 8 summarizing it I grant you is a huge task. 9 And I think you guys have 10 generally done a very good job with that huge

11 task. But because it's such an extensive 12 literature, there's variability in its 13 quality. And I think that message is not as 14 well conveyed as it probably should be. 15 And I think it's important in 16 terms of understanding the nuances of where 17 lead is likely to be a health hazard, and

18 where it's not. 19 So examples of that, I think in 20 the revision, understanding how the weight of 21 evidence is applied in the studies that were 22 reviewed in Chapter 5 is I think it's not as Page 229 1 comprehensive or nuanced as I think it should

2 be. 3 And I think examples of that are, 4 for example, the issue of confounding is 5 brought up much more in this version than the 6 previous one. But it's not always talked 7 about in a very accessible way for the reader. 8 So for example, there are some 9 sections of this chapter where confounding 10 isn't mentioned much. Or it's mentioned only

11 in the sense that these were the confounders 12 that were adjusted for.

13 And there's not much discussion 14 about whether that was considered adequate,

15 whether studies in which confounders weren't 16 adjusted for are less valuable than ones in 17 which they were. 18 And the intellectual way in which 19 confounding is dealt with is very superficial 20 on some level. And in that way it doesn't 21 help with understanding the weight of evidence 22 around sort of confounding issues.202-234-4433 Neal R. Gross & Co., Inc. Page 230 1 I think a more specific example of 2 this is for example, in the nervous system as 3 well as the immune system discussion, there

4 were several statements to the effect that 5 failure for adjustment to likely confounders 6 didn't change findings much in Study A. 7 Therefore, Study B's lack of adjustment for 8 confounding doesn't matter. 9 And that's not a typical 10 epidemiologic perspective on confounding. 11 Confounding can be very study specific. And 12 so to use that as a way of excusing lack of -- 13 What I would say is that in 14 studies where confounding important potential 15 confounders were not accounted for, the 16 results of those studies should not be given 17 the same weight. 18 And that's not how this weight of 19 evidence analysis was done. And I would say 20 it's an unconventional, sort of a euphemistic 21 way to put it would be, that would be an 22 unconventional way to think about confounding. Page 231

1 That because it didn't seem to 2 make much difference in one study, the fact 3 that another didn't adjust for it didn't 4 matter. I think that's really not a statement 5 that you want to have. And it comes up in 6 this chapter several times.

7 And I think there's also a more 8 fundamental question, which is for some 9 outcomes some key confounders, and Michael 10 looked at this much more carefully than I,

11 were not mentioned. And I think that's an 12 oversight that ideally should be corrected. 13 And I think again, in the weight 14 of evidence rubric there's a couple of other 15 ways in which the revision fell a little short 16 of what I think would be an ideal goal. So 17 around issues like study design. 18 There are a number of topics where 19 there's a mix of prospective and cross 20 sectional studies. And sometimes in reading 21 the chapter it's actually hard to tell what's 22 prospective and what's cross sectional. Page 232

1 And for certain health outcomes 2 that really matters, both in terms of whether 3 you might be concerned about reverse 4 causality, and also whether the sort of timing 5 of exposure is -- you can make inferences 6 about critical timing for exposure.

7 And I think that distinction is 8 not very well made in most of the sections of 9 the chapter. And I'll give you an example. 10 So for example, in the nervous systems section 11 for ADHD studies that have been done, say 12 using NHANES data. 13 Those are by definition cross

14 sectional studies. And there are a number of 15 limitations with those studies, including the 16 cross sectional nature of the exposure outcome 17 assessment. But also including the nature of 18 the outcome assessment with parental reported

19 ADHD.

20 And none of those issues are 21 brought up. And I think those studies, 22 although I think some in the field believe Page 233 1 them to be fairly definitive.

2 I think those studies have a lot 3 of methodologic limitations, which are not

4 discussed. And that need to be discussed more 5 to put them in proper perspective from a 6 weight of evidence point of view. 7 And then I think the other, there 8 are two other points I'll make. And then I'll 9 let others comment. I think the, in general 10 the issue of exposure timing from the 11 perspective of blood leads in older 12 populations is not necessarily reflecting the 13 ideologically relevant exposure, was very

14 clear. 15 But I think exposure timing in

16 another context was not so clear. And that 17 is, especially again in the nervous system 18 section, there are a number of places in which

19 a comment is made that in recent literature 20 concurrent exposure appears to be the more 21 toxic, or the more important. 22 And then within the same paragraph202-234-4433 Neal R. Gross & Co., Inc. Page 234 1 there'll be a statement that says, there's 2 still substantial uncertainty about which 3 exposure period, early life, concurrent, is

4 the most deleterious. 5 And I think those apparent 6 contradictions, it may just be a word smithing 7 issue. It may be that the key is that recent

8 literature has demonstrated that concurrent 9 exposures in later childhood are still 10 deleterious, which may not have been the 11 historical perspective. And that that's an 12 important new piece of information. 13 But it doesn't preclude the 14 importance of earlier life exposures. And one 15 is not necessarily, they're not mutually 16 exclusive exposure time periods. And so are 17 risk factors. And that subtlety is lost in 18 the wording, which ends up seeming 19 contradictory. 20 And I think the last thing. This 21 is sort of again apropos of our discussion 22 before the break. I get the impression that Page 235 1 there's been some cutting and pasting of text. 2 And this may be what George Allen was 3 referring to. 4 There are sections of this chapter 5 that really don't make any sense. And they're 6 sections that deal with topics that I'm pretty 7 familiar with. So the only way I can -- 8 They're like almost incomprehensible.

9 And I think what must have 10 happened is there must have been some cutting 11 and pasting that went on, and some editing. 12 So that the original meaning, or whatever it 13 was -- I can't imagine that someone actually 14 wrote this, the original. Because it just

15 isn't -- 16 And the prime example is, there 17 was a discussion about ALS, the sort of 18 potential for differential survival to bias 19 the relationship between lead and the rest of 20 ALS. And it's incomprehensible. 21 So I think I would just urge you 22 go through with a experienced read and make Page 236 1 sure that some of the more complicated 2 sections are really saying what you think they

3 are. Because from a reader who didn't write 4 it, some of them are very hard to understand. 5 And I think there's a good message 6 in that ALS section, but it's completely lost 7 in the way it's currently written. So I think 8 I'll stop there in terms of just sort of an 9 overview of some of the issues that I thought 10 were important, and let others comment. And

11 then we can circle back around. 12 DR. FREY: Great. Thank you,

13 Susan. Dr. Canfield. 14 DR. CANFIELD: Thank you, Dr. 15 Korrick, for doing an excellent job of an 16 overview. You captured many, most of my

17 concerns as well. 18 I characterize it to myself as a 19 great deal of unevenness, and the completeness 20 of the exposition going from section to 21 section, or paragraph to paragraph sometimes.

22 And I found it sometimes difficult Page 237 1 to read, because there seemed to be a lot of 2 run on paragraphs where there is really a 3 change in study, or a change in topic, but 4 there was no new paragraph. So it took me a 5 while to go back and figure out that, oh wait, 6 now this isn't the same as what I was reading

7 before. 8 So there's some, also, 9 editorially, some housekeeping things. There 10 was cutting and pasting where there were 11 repeated sentence and repeated sections that, 12 you know, clearly had been pasted over, but 13 didn't get cleaned up.

14 But in terms of more substantive 15 issues, I did appreciate the approach to 16 pointing out homologies between the animal and

17 the human task. But I think it was a bit

18 overdone. 19 I think the, for example, the 20 section of the Morris water maze and making 21 that on the one, and let's see it done on Page 22 5-73. It's described that the CANTAB is, it's202-234-4433 Neal R. Gross & Co., Inc. Page 238 1 described as sharing homology with tests used

2 with the Morris water maze. 3 But then on page 5-88 it's the 4 Morris water maze is homologous to the spatial 5 memory components of the CANTAB and WISC-R. 6 And then later it says in 5-100 for the Morris

7 water maze results. It said that these animal 8 observations provided strong coherence with

9 associations with children. 10 And then in 5-102, tests of 11 learning and memory in animals that are 12 directly homologous to tests conducted in 13 children. So it sort of goes from what I 14 would agree with, which is sharing homology. 15 And I think it's a fairly nice job 16 of characterizing the level at which they're 17 the same. And then gradually, by the time we 18 get to the, closer to the end of the sections, 19 they're directly homologous. And I don't 20 agree with that. 21 And I can give you some more 22 details on why I, what differences I would Page 239 1 point out between the CANTAB tests and the 2 Morris water maze, in terms of spatial 3 navigation and possible stress component of

4 the water maze that's not reflected in the

5 CANTAB. So that was one issue.

6 I have a number of these that Dr. 7 Korrick already mentioned. Oh, I also thought 8 that it wasn't very helpful to have 9 characterizing of early exposure from 10 conception through, you know, early infancy as

11 short duration. 12 I think it, in some areas, the 13 toxicology studies, the exposure durations

14 were one hour or 24 hours in cell culture. 15 But I think the notion of conception through 16 birth being a short exposure duration is a 17 little misleading. 18 Another issue was relation, when 19 we talked about the dose response 20 relationships. And the non monotonic, or the 21 superlinear versus the U shaped dose response 22 curves in toxicology. Those are in my Page 240 1 understanding quite different. Or at least 2 not necessarily the same results. 3 In the tox studies where you have 4 say an effect at a low level, or no effect at 5 a low level, effect at a medium level, and no 6 effect at a high level. Or, you know, 7 whatever you get in many of these. You get no 8 effect at a high level. 9 That's not what's going on in the 10 superlinear blood lead I.Q. situation, where 11 higher blood lead is still worse than lower 12 blood lead. It's just that the rate of change 13 in functional decline is less, okay. So those 14 should not be mapped one to the other, because 15 they really are quite different effects, in my 16 understanding. 17 I did think there were many good

18 statements of the sort that "There's 19 uncertainty regarding the frequency, duration, 20 timing, and magnitude of exposure contributing 21 to the blood lead levels among --", and some 22 population. And I think that could be used Page 241

1 somewhat more. And this is similar to what 2 Dr. Korrick was mentioning. 3 And in particular, I think in 4 studies, in cross sectional studies of school 5 age children, those statements need to be more 6 prevalent, just as in adults. Because 7 especially, for example, in the NHANES studies 8 in particular, when we have blood lead levels 9 of 7.5 or five or something in an 11 or 16 10 year old child in 1994. 11 We really don't know what that 12 means about exposure earlier in life, similar

13 to an adult. Now it becomes less and less 14 uncertain as time marches forward, and the 15 range of lead levels is less. But still we, 16 I think it should be included in many of those

17 studies.

18 And it is related to Dr. Korrick's 19 comment on making clear distinctions between 20 cross sectional data and longitudinal data in 21 this regard. Because that, I also had 22 difficulty, even knowing the literature202-234-4433 Neal R. Gross & Co., Inc. Page 242 1 somewhat, keeping track of when the 2 longitudinal result was being compared as 3 similar quality and validity to a 4 longitudinal, going from one outcome to

5 another. 6 So other issues, I wanted to point 7 out that in Pages 5-86, Table 5-6, where the 8 Beaudin et al, and Stangle et al studies. 9 That's out of Barbara Strupp's lab at Cornell. 10 Some of their most prominent 11 effects are in what they call error 12 reactivity, which they characterize this as an 13 emotional effect. An effect on emotionality. 14 And so I was thinking that, you know, it's in 15 a cognitive section in Chapter 5. 16 And I think it would be good to

17 look back at those studies and consider 18 putting them also in the mood emotion, or in 19 the behavior sections. It's not entirely 20 clear to me where you want to put those. And 21 I don't think it's entirely clear how to 22 interpret their error reactivity measure. Page 243

1 But there should be at least some 2 discussion of that. I think it might provide 3 some animal toxicology insight into the

4 behavior and emotion sections of this 5 document. I'm wondering if I'm going on too 6 long. 7 DR. FREY: If you feel you have 8 something important to say, please say it. 9 DR. CANFIELD: Well stop me. One 10 thing that's important to say is that I do 11 have an overall very positive view of this 12 chapter. I think this is -- 13 Whenever I felt sorry for myself 14 reading it, I only had to think of what it 15 must, the work that went in to producing it, 16 to get it to the point that it's at. And it's 17 a very impressive amount of work. So this 18 comes across as quite negative, but it's

19 because time doesn't allow for too much 20 praise. Yes, thank you.

21 DR. VANDENBERG: We'll wait. 22 DR. CANFIELD: Okay. So in the Page 244 1 section on chelation, I think there, I didn't 2 see mentioned of the work, also coming from 3 the Strupp lab, on showing that chelation 4 itself confers potential cognitive impairment. 5 So just chelation alone. And that could be 6 wrapped into the interpretation of some of

7 these chelation effects. 8 Then the work on, the section on 9 Page 5-100 on methionine, choline 10 supplementation. And that shows that it did

11 not reduce brain lead. But it did cause 12 improved learning and memory in rats. 13 And I thought it might be worth 14 including a sentence or two about the work on 15 early choline supplementation and memory and 16 attention in rats. And that's work by 17 Christine Williams and Warren Meck, at Duke. 18 And you do mention Blusztajn and, 19 starts with a Z, can't remember it. You do 20 reference the Blusztajn work, but what's more 21 particularly relevant to the choline, would be 22 the Williams and Meck work on cognition. Page 245 1 Because it may be that you get an 2 independent effect of the choline on improved 3 cognitive function, even though brain lead 4 didn't change. 5 But there wasn't enough detail to 6 know actually when that choline 7 supplementation was administered. At least in 8 the text. So I can provide more detail on 9 that, and I won't go into it more right now. 10 Let's see. I thought your 11 discussions of SES were good in a number of 12 places. And it is a complex issue. And 13 there's so much variability and lack of 14 comparability in so many of the lead studies, 15 that it's not easy to draw a clear conclusion. 16 But I thought it would be useful, 17 and other people can comment on this. But I 18 thought often about what an instructive 19 comparison is. 20 The comparison between the 21 Rochester and Boston studies, in terms of the 22 cohort differences on the one hand, and the202-234-4433 Neal R. Gross & Co., Inc. Page 246 1 similarity of the effects of lead that were 2 reported on the other end.

3 So in Boston of course we have the 4 high SES, high I.Q., you know, excellent, 5 seemingly excellent parenting and education,

6 and all kinds of beneficial social factors. 7 And lead levels in the, you know, averaging

8 below ten for the maximum. 9 And then in Rochester you've got10 mostly single parents, mostly African11 American, quite low income. Really not such 12 good social circumstances. And lead levels at

13 about the same as Boston. 14 So you have two very, about most 15 contrasting social environments, or social 16 ecologies that you are likely to find in the

17 U.S. And it turns out that the effects of 18 lead, both for the full range of lead levels 19 and less than ten, turned out to be very, very

20 close. 21 And so that is another that adds, 22 I think, something to the view of where SES Page 247 1 fits in this. It's not a quantitative 2 comparison, but a qualitative comparison that 3 might be helpful. 4 I thought there might be some -- 5 I guess I had an overall concern about a bit 6 of a conformation bias that pervaded the 7 document. That it, it's hard to put my finger

8 on. 9 But one thing that I thought could 10 be helpful, is that there should be, at least 11 some point. Maybe I missed it. But a mention 12 of like unpublished studies that showed no 13 effect, that are in somebody's file drawer. 14 And we don't know what they might 15 add to the picture if they were there. So 16 that's always there of course. But I'm just 17 mentioning that might be helpful as a source 18 of uncertainty. I think I'll stop there. 19 Thank you for your patience. 20 DR. FREY: Okay. Thank you. Dr. 21 Cory-Slechta. 22 DR. CORY-SLECHTA: Okay, I first Page 248 1 of all support all the comments that I've 2 already heard from my colleagues, and want to 3 commend you for the improvements that are 4 obviously in this chapter. I have a couple of 5 things that I want to add to what was already

6 said. 7 I have some concerns about using 8 the term, the clinical diagnosis ADHD. All 9 but one of those studies are based on parental 10 or teacher reports. And while I'd probably 11 put a lot more credence in a teacher's report, 12 because they see a lot more children. I think 13 all of us who have children probably thought 14 our children were out of control at one point

15 or another.

16 So I have some real concerns about 17 tagging that to an actual clinical diagnosis. 18 Unless you can demonstrate to me some studies 19 that show the predictive capacity of parent or 20 teacher ratings to clinical diagnosis. I'm 21 not aware of any of those kind of things. And 22 I would guess the correlations aren't all that Page 249 1 high. 2 I'm very comfortable with talking

3 about attention related behaviors. There's 4 ample evidence to cite that. But to call it 5 ADHD gives it a clinical moniker that is not 6 convincing based on the absence of studies in 7 which clinical diagnoses were actually carried

8 out. 9 So that is in Chapter 5, but it 10 also shows up in other places in the text as 11 ADHD. I'd be much more comfortable if you 12 called that, you know, attention related 13 behavior, something to that effect. 14 I want to go back to this issue of 15 homologies. Because it's clear that the 16 people who wrote this part of the chapter 17 aren't very comfortable with behavioral 18 assays.

19 And the Morris water maze -- 20 First of all, there are many places where 21 CANTAB is cited as if it's some unitary 22 phenomenon. CANTAB is simply a company from202-234-4433 Neal R. Gross & Co., Inc. Page 250 1 which you can purchase tests of learning, 2 memory, or attention. 3 It is not a battery. It is not a 4 unique battery. When we do CANTAB we may use 5 very different tests depending on the 6 questions that we're asking. And yet if you 7 read through here, you would get the sense 8 that somehow CANTAB was a unitary thing. 9 There are places where the 10 homologies do fall apart. Although, Rick, you 11 might be interested to know somebody has a

12 virtual Morris water maze for children. So 13 they don't actually -- Go figure. 14 I absolutely understand that. So 15 I was going to point that out. The Morris 16 water maze -- If you want to get a homology 17 to the animal studies, it would be reversal 18 learning, and the intra/extra dimensional 19 shift set, something like that.

20 That test is never mentioned in

21 here. You talk about outcomes and don't 22 always stipulate the name of the test in here. Page 251 1 And I think it's important to stipulate the 2 name of the test so people reading it will 3 know what, in fact, you were measuring. So 4 yes, there are some homologies that clearly

5 are overextended.

6 I also want to remind us that in 7 the old days, coming back to this issue of the 8 weighting of importance of studies. There are 9 some in here that are actually ecological, so 10 to speak. But in the old days, and I 11 understand the goal here was really to 12 integrate.

13 But the criteria document used to 14 actually differentiate cross sectional from 15 longitudinal studies in its presentation, with 16 a sub title or sub heading. That might go a 17 long way here to getting around this problem. 18 But I agree it's very -- there is 19 no apparent weighting as far as I can tell of, 20 you know, the greater weight to the 21 longitudinal, versus the cross sectional. And 22 I think that's always been a very important Page 252

1 distinction as we've moved forward. 2 The other thing about the 3 concurrent lead exposure, which really has 4 become sort of a change in our thinking over 5 the years, is that I think it says in addition 6 to this problem --

7 And I don't think we'll ever solve 8 this problem of knowing which particular

9 behavioral or brain functions are disturbed at 10 what points in time necessarily. The fact 11 that you have effects with concurrent blood 12 lead also suggest the importance of lifetime 13 lead exposure. 14 And something else that you did 15 mention very briefly, and I brought this up 16 before. And that is the effect of early 17 failure on your later success, independently 18 of any more lead exposure. If you don't do 19 well in first or second grade, you're probably 20 not going to be the class Valedictorian in 21 high school. 22 So that's completely independent, Page 253 1 if you will. Early failure is a good 2 predictor of later failure for the most part, 3 without intervention. So I think those are my 4 comments on top of what I've already heard.

5 Thanks. 6 DR. FREY: Okay. Thank you. Dr.

7 Kosnett. 8 DR. KOSNETT: I am, I guess I'm 9 less sanguine about my analysis of the 10 revisions than my colleagues. Because I feel 11 that some of the major points and desires that 12 we had requested in the previous report have, 13 unfortunately, not been satisfied. 14 I'll start though by saying one of 15 the key ones that was satisfied, was that we 16 made a point that a lot of the analyses in 17 adults that looked at concurrent blood lead, 18 can't necessarily be imputed to their current

19 blood lead. 20 Because, you know, like 21 hypertension differences. And people with 22 blood leads less than five, or renal affects202-234-4433 Neal R. Gross & Co., Inc. Page 254

1 in blood leads less than five. Because all

2 the adults that have been studied had the 3 majority of their lives with blood leads 4 greater than ten. 5 So that has been recognized. And 6 I think that was good, and I was glad to see 7 that. The major big picture concerns that I 8 had was, I think that the whole approach to

9 causal determination should be revisited. And 10 I, you know, I have more extensive written 11 comments. And time won't permit me to go into

12 it in detail. 13 But, you know, essentially EPA in 14 their preamble basically says, in order to 15 establish causation, you have to have multiple 16 high quality studies that see it. And you

17 have to be able to have control for bias or 18 confounding with reasonable confidence. 19 I would also probably say that you 20 probably need to have biological plausibility, 21 and hopefully some kind of dose response. But 22 this type of analysis isn't really put forth Page 255 1 in each of these end points. 2 In other words, has confounding 3 been adequately looked at? Have, you know, do 4 the toxicological studies support it at the 5 same dosage that is attributed in the 6 epidemiological studies?

7 Now it's better for some than

8 others. But for several of them that hasn't 9 been done. And a lot of times you see this 10 phrase. I think it shows up multiple places

11 in the document. 12 The weight of the evidence 13 supports the association. As if that's a 14 causal determination, okay. Just because 15 there's evidence that supports an association,

16 doesn't mean that the association is causal. 17 Because supposing it's due to confounding, 18 okay. 19 So that phrase continued to show 20 up, you know. And I think it really needs to 21 behave. You know, like on Page 5-218,it says 22 the weight of the evidence demonstrates Page 256

1 association within attention and 2 hyperactivity.

3 Well that's not a causal 4 determination, just because there's an 5 association. What about the potential 6 confounding issues?

7 Well for the newer behavioral end 8 points, I think in particular the document

9 merits reconsideration and revision to examine 10 the limitations of the neuro behavioral data, 11 particularly in comparison to the cognitive 12 and I.Q. data.

13 And one of the reasons for that is 14 that there's been a paucity of success in 15 adjusting for parental psychopathology in 16 behavioral outcomes, such as inattention and

17 ADHD. 18 And we pointed that out in our 19 comments in the December CASAC report. And we

20 said that literature should be reviewed for 21 that regard. 22 And we also said, basically, that Page 257 1 in the tables that set forth all the studies,

2 it would be nice to have a column that showed 3 the limitations of the key strengths and 4 limitations of the key studies. 5 For example, the ones that didn't 6 control for psychopathology in the parents.

7 Or didn't control for home school or other 8 things like that. And that hasn't been done. 9 And in fact, a lot of the evidence 10 has been said to, you know -- there'll be 11 things like on the neurobehavioral studies 12 that says, well this was found after 13 controlling for things like maternal I.Q. and

14 socioeconomic status. 15 But that's not, those are not 16 adequate controls for behavioral end points. 17 In large part because -- They're not 18 sufficient I should it that way. Not 19 sufficient because in large part a lot of 20 behavioral deficits are considered to by 21 highly heritable. 22 Also to the extent that they can202-234-4433 Neal R. Gross & Co., Inc. Page 258 1 be explained by models, the models tend to 2 have very low R-squared, about ten percent. 3 Models of intelligence can explain maybe 25, 4 30 percent of intelligence. 5 We know for example that maternal 6 I.Q. is the single huge predictor of child 7 I.Q. We don't have an equivalent test to give 8 the parents. Or if we do, it's not been done,

9 to include in the models. So there's a lot of 10 potential for residual confounding in these

11 behavioral outcomes. 12 And I think throughout, that 13 failure to mention that is a significant 14 shortcoming. I think that it's also maybe 15 even more significant, because a lot of times 16 in this discussion in here they're lumped 17 together in the same sentence. 18 It will say, because of the 19 effects on lead on cognition and behavior. 20 But they're really, the strength of the 21 literature and the maturity of the literature 22 is quite different between the effects on Page 259 1 cognition, which I think is very strong, and 2 on behavior, which isn't. 3 And for example, there's many 4 sentences that say it's consistently observed,

5 that effects of lead on inattention are 6 consistently observed. Well I would challenge

7 that. 8 For example, two studies by 9 authors who are sitting right here at the 10 table, which were some of the best studies of 11 this, because they were perspective studies, 12 looked at the impact of lead on attention. 13 Gail Wasserman's study of children in 14 Yugoslavia. And with respect to the attention 15 aspect of the behavior the lead exposure 16 wasn't significant. 17 And then Dr. Canfield's study in

18 Rochester of the children with low blood 19 leads, the one you published in 2003, Rich, of 20 executive function. At best you might have 21 inconsistent or marginal effects of lead on

22 attention and other measures of executive Page 260 1 function. And those are very good studies. 2 And they weren't mentioned. 3 They certainly don't paint a 4 consistent picture at low levels. And yet 5 they were not mentioned in here. So that

6 concerned me. 7 I was also concerned on, and I

8 made extensive comments on the renal issues. 9 And I don't need to go down in the weeds about

10 it. But I think the document has backed off

11 a little from the first version on the 12 relationship between low level lead exposure 13 and renal dysfunction. 14 But nevertheless, it still doesn't 15 address some of the major concerns about that 16 literature. And there were three things in 17 particular in our consensus comments that we 18 pointed out.

19 We said that the issue of reverse 20 causation has not been ruled out. We pointed 21 out that there's not consistency, because some

22 studies have found it and some studies haven't Page 261

1 found it. 2 And we also pointed out that there 3 was a lack of a pathological mechanism for 4 nephrotoxicity at low blood lead 5 concentrations, like blood lead concentrations

6 less than 15 microns for deciliter for 7 example. And I don't think that all those

8 comments and the uncertainties that those 9 produce with causal analysis with lead and

10 renal deficits -- 11 And we're talking about low level

12 lead and renal deficits. Not lead and 13 nephropathy at high doses. I don't think that 14 that has been given the balance that it 15 should, it would merit. And I won't go into 16 all the details of that, because you can look 17 at my written comments for that. 18 The other thing is, there's a 19 section in here on confounding, and the 20 influence of confounding on neurobehavioral 21 outcomes. And it's a new section, which is 22 good.202-234-4433 Neal R. Gross & Co., Inc. Page 262 1 But it was surprising that this 2 new section on confounding and neurobehavioral

3 outcomes didn't mention the fact that 4 confounding by parental psychopathology hasn't

5 been addressed. 6 I was really surprised that that 7 was missing, because we had explicitly 8 requested that it be put in there. So those 9 broad stroke things on causal determinations 10 and analysis, I think merit careful attention

11 and discussion. 12 I think for virtually every end 13 point you should, it would be helpful to go 14 through and say, okay, for these specific

15 effects this is the causal framework. Have we 16 ruled out confounding? Have we seen dose 17 response? Did we see biological plausibility 18 through mechanisms at these low doses? 19 And based on that, can we conclude 20 that there's a causal relationship at a 21 particular endpoint of a particular dose? 22 That's really going to be helpful. This Page 263 1 document will make a huge contribution if it

2 can do that. 3 But right now it still has a long 4 way to go before it can accomplish that. And 5 I hope that it can be done in the next draft. 6 And I hope we can see it as well. Because I

7 think it's substantial. We need to do that. 8 Thank you. 9 DR. FREY: Okay. Thank you. I 10 think the last point you raised there about 11 opportunity to see a draft, and so on. I

12 think we can circle back to that after we kind 13 of see what the totality of comments are. Dr.

14 Wasserman is next. 15 DR. WASSERMAN: If people recall, 16 when we talked about in the last version, we 17 made a distinction between delinquency and 18 delinquent behavior. And perhaps just even 19 making that distinction between attention 20 problems and attention deficit disorder would 21 clarify some of what's going on. 22 But regarding the provision of a Page 264 1 clinical diagnosis, the way we would give a 2 clinical diagnosis is to query the parent and 3 to query the teacher. I mean, you don't 4 arrive at a diagnosis of ADHD frankly in any 5 other way. 6 You might give a continuous 7 performance task. But basically the clinician 8 will integrate information from other people 9 who are reporting on the child's behavior. 10 Children with ADD are notoriously bad self 11 reporters. So they're not going to tell you. 12 So these are components that would 13 feed into a diagnosis. Although they are not 14 the same thing as a diagnosis. And a 15 clinician would not take, would not 16 necessarily -- 17 If the parent reports ADHD 18 symptoms, but the school does not, they would 19 probably dismiss that, and vice versa. If the 20 kid is problematic in one setting and not in 21 another, they would see how he behaves in the 22 office. But generally it's thought you've got Page 265 1 to get two out of three major settings for

2 attention deficit behavior to arrive at the 3 diagnosis. 4 So the symptom scales, or the 5 distractibility type behaviors reported by 6 whoever they're reported by, are a component, 7 but they are not the same thing as. So I 8 think that would be a helpful distinction. 9 There's a couple of other places 10 in which the weighting of the evidence is a 11 little confusing to me. Between Pages 62 and 12 64, there's a discussion of a series of papers

13 from Asia in which the usual confounders don't 14 contribute to intelligence. That to me is a 15 red flag that you have somehow misconstructed 16 your construct. 17 That if, you know, Pat Shrout, 18 when we started our work in Yugoslavia said, 19 you know, if it walks like a duck and talks 20 like a duck, and quacks like a duck and swims 21 like a duck, it's probably a duck. So we 22 always check to make sure.202-234-4433 Neal R. Gross & Co., Inc. Page 266 1 If we got a thing and it was -- 2 Because we were measuring I.Q. in a place that 3 we didn't have any reason to think we could do 4 that reasonably. If it bore the same 5 relationship to all the other things in its 6 social environment, that construct. That we 7 probably could call it I.Q. 8 So I'm worried when I see papers 9 in which lead relates to I.Q., but the usual

10 cast of characters in a social environment

11 does not. Not that lead's been 12 mischaracterized. But probably either the 13 confounders or the I.Q.s not very well. So 14 that's the kind of cement in evaluating 15 studies that, I know it's a tough task. But 16 I think that would be helpful here. 17 Just another comment on parental 18 psychopathology. It is extremely difficult to 19 measure parental psychopathology in a large 20 epidemiologic survey. Largely also because 21 most symptoms of ADHD will wane after the age

22 of 15 or so. Page 267

1 So most adults who are parents 2 won't show you very much, or have much memory 3 of what they had as a diagnosis. Whether they 4 had a diagnosis in the past. 5 Michael pointed out the study in 6 Romania in which they called and they asked 7 parents of kids, you know, did you ever get 8 this diagnosis? 9 I can assure you, having worked 10 very close to Romania, that the likelihood 11 that most 30 year olds, when they were eight 12 to ten in Romania, had access to a competent 13 mental health practitioner, and a school that 14 functioned to ascertain parental 15 psychopathology in that way, it just didn't 16 happen. 17 So I guess what we're asking is, 18 is there some way to go beyond whether this is 19 a published study? Therefore, all the

20 inferences that the authors make should be 21 accepted at face value. And is there still 22 more critical editing of evaluation that can Page 268

1 come to bear? 2 I like very much your suggestion, 3 Michael, that we take criteria and say, you 4 know, it should do this, it should do this, it 5 should do this, it should do this. 6 If the body of evidence in this 7 section does, you know, five of these seven 8 things, we're cool with it. If it's down to 9 two, it's a little bit more worrisome. If 10 there could be more editing like that. 11 I have a comment on the homology 12 issue as well. There's one point in Page 5- 13 91, where they're relating maternal self

14 esteem in humans with maternal stress in 15 animals. And I think you'd have a real hard 16 time making that equation.

17 Stress in an animal mother -- 18 Elsewhere I've seen it related to depression. 19 So whether self esteem seems like a very far 20 stretch to maternal stress. Clearly stress is 21 not good, and it might relate to all sorts of 22 other packaged mother's behaviors. Page 269

1 But to equate it to maternal 2 stress with a little bit, without more 3 documentation of how that translation might 4 be, I would have trouble with.

5 And then a little bit later on in 6 that same section, there's a discussion of 7 overall fixed interval rate being called a 8 hyperactive behavior. And I wasn't sure what 9 you all were meaning by that. 10 If you meant overactive behavior, 11 or the equivalent of hyperactivity ADHD. 12 Because those are two very different things. 13 Especially since so much of ADHD relates to 14 issues of attention management, and not 15 necessarily hypermotoric response. Again, 16 really needs to be some more connection going

17 on. 18 I really appreciated the section 19 in here that relates back to Chapter 2, on the 20 public health significance of small effects. 21 I know I was very difficult about that before. 22 I think that's really an improvement here in202-234-4433 Neal R. Gross & Co., Inc. Page 270 1 what is presented. Excuse me.

2 I still have trouble with the 3 discussion around Page 214 that relates back 4 to the figure that's presented in Chapter 2.

5 I can talk about it here or when we talk about 6 Chapter 2. The discussion is in Chapter 5 and 7 then the summary of the discussion is in 8 Chapter 2. The actual figure is presented in 9 Chapter 2.

10 DR. FREY: Well if it's salient to 11 Chapter 5 and if it wouldn't take too long, 12 then go ahead. 13 DR. WASSERMAN: Okay. The figure 14 is one in which you've got a distribution of 15 I.Q. in the population, based upon exposure. 16 I's a Chapter 2 figure. And it's the model 17 that says even small effects can have large 18 population consequences. If you shift the 19 higher -- 20 DR. FREY: Gail, could you just 21 point us to what figure is it, or what page? 22 DR. WASSERMAN: The figure is on Page 271 1 255, but the discussion really is in Chapter 2 5, like Pages 213 to 216. 3 DR. FREY: Okay. And could we 4 post that? This is from Chapter 2, Page 55. 5 DR. WASSERMAN: I'm sorry, Page

6 255. 7 DR. FREY: Page 255. 8 DR. WASSERMAN: Yes, posting it is 9 better. There it is. Okay. So the idea is 10 that we might move more people into the 11 clinical range, even with a very small effect 12 size. Because the entire distribution might

13 be shifted.

14 And this is a model. This is a 15 statistical projection. It's referred to on 16 Page 214 as based on purely statistical 17 grounds. But I'm thinking, as before we had 18 a discussion of distinguishing between what's 19 empirical and what's modeled. 20 The model doesn't really take into 21 -- It assumes linearity across levels of 22 ability and exposure. It assumes that the Page 272 1 effect of a given amount of lead is going to 2 have the same adverse impact, regardless of 3 where your ability is. And we really don't

4 know that. 5 And nothing that's offered in the 6 discussion in Chapter 5 or Chapter 2 really 7 speaks to that. That we don't know about the

8 bottom end of that curve. We haven't included 9 kids in that level, at the bottom edge of the 10 I.Q. distribution.

11 And it was hard for me to find 12 where you said this is only a model, this is 13 a possibility. And I think it's so important. 14 Because somebody's going to look at that and 15 say, oh my God. Yes, look how we are 16 definitly increasing the number of seriously

17 retarded individuals.

18 And I don't know that we have 19 really enough information at the lower end of

20 the distribution to make that statement. If 21 anything, this figure calls out to me, maybe

22 we need to do more research that concentrates Page 273 1 on kids who are disabled from things other

2 than lead. And look at the contribution of 3 lead to I.Q. in other populations of kids with 4 already disabling conditions.

5 But somehow this needs to be

6 clarified that this is a model. And the model 7 doesn't really address the issue at that 8 bottom end that's so scary. It's very scary 9 to look at this picture. But it isn't based 10 on anything.

11 DR. FREY: I think there's a

12 clarification comment. Yes. 13 DR. RABINOWITZ: Yes, just briefly 14 on this point, which struck me as well. The 15 phrase I wanted to add to the caption would 16 be, assuming the shapes of the distributions 17 don't change. Now having said that -- 18 DR. WASSERMAN: Assuming the 19 impact. It's a linear impact, right? 20 DR. RABINOWITZ: Yes. Assuming 21 everything just shifts without changing the 22 shape. I just add to that a secondary thought202-234-4433 Neal R. Gross & Co., Inc. Page 274 1 that, if you design an intervention to reduce 2 lead exposure, not all interventions will 3 affect everybody equally.

4 So sometimes interventions will 5 change the shape of the curve. But yes, it 6 is, the same alarm bell went off in my mind. 7 I'm not sure how to deal with it, except maybe 8 explain it away. 9 DR. WASSERMAN: To me, in my 10 experience dealing with, clinically with 11 people who are at the very low end. It's 12 really sometimes very difficult to demonstrate 13 the impact of social environmental effects on 14 people who are profoundly retarded.

15 And I don't know whether that is 16 because it's so hard to measure I.Q. in the 17 30, 40, 50 I.Q. point range. That it's a 18 measurement issue. Or is there something 19 that's very invulnerable to change once you've 20 gotten that far down.

21 But I know that this curve is 22 unlikely to be a reasonable projection at that Page 275 1 level. And it keeps appearing. And somehow, 2 and I keep ripping it up. 3 And I think we just need to say, 4 this is a statistical projection. It's based 5 on estimates which may or may not take place. 6 It would be really cool if we had data at the 7 bottom end, but we don't.

8 DR. FREY: I think this has 9 generated some related discussion. If you 10 don't mind we could go off on that tangent for

11 a minute. 12 DR. WASSERMAN: No, no, no. I'm

13 done. 14 DR. FREY: Okay. All right. So 15 Dr. Cory-Slechter and then Dr. Canfield.

16 DR. CORY-SLECHTA: Well first of 17 all, I think, you know, this has been around 18 for a long time. I don't think it's even 19 statistical. It's really theoretical. 20 DR. WASSERMAN: Okay. 21 DR. CORY-SLECHTA: So maybe if

22 it's called theoretical instead of statistical Page 276 1 that would help clarify it. 2 DR. WASSERMAN: On Page 214 3 they're talking about, I'm assuming the same 4 things based on purely statistical grounds. 5 I thought that they were linked, but maybe 6 they're not.

7 DR. CORY-SLECHTA: No. It's been 8 a theoretical thing. And it was published a 9 long time ago. I did want to return to the 10 issue of attention. Because we got caught in 11 describing that as if it was a unitary 12 phenomenon.

13 And I think in addition to 14 thinking about the strengths of all those 15 studies, it has to be recognized that 16 attention is not one thing. 17 A diagnosis of attention deficit 18 disorder can mean you have two of three 19 different diagnoses. So Michael, when you 20 talk about comparing studies, unless they're 21 comparing the same behavioral domains, the

22 same -- Page 277

1 Because attention is one big 2 construct. You can't compare them. I can't 3 directly compare a study of impulsivity to one 4 of hyperactivity. They're not the same 5 outcome. So I don't think that got adequately 6 recognized. 7 I did want to come back to your

8 statements about the fixed interval schedule. 9 In fact, that has been demonstrated to be a 10 surrogate of impulsivity in children. 11 Children who have high rates of 12 responding, that's learned behavior on an FI, 13 also show in a delay of reward task, always 14 choose the short delay. So that's -- 15 DR. WASSERMAN: I wasn't saying 16 that it wasn't. I just said the dots weren't

17 connected. I didn't know if it was considered 18 as a symptom of --

19 DR. CORY-SLECHTA: Well it should 20 be considered more. It's not "hyperactivity". 21 This is learned behavior. It should actually 22 be thought about in terms of impulsivity.202-234-4433 Neal R. Gross & Co., Inc. Page 278 1 That's really what it's been 2 demonstrated to be a surrogate of in children. 3 In the same children, FI and delay of reward 4 performance. So it might go better in that

5 kind of a situation.

6 DR. WASSERMAN: Thanks. 7 DR. CANFIELD: I just wanted to 8 add something to this population figure, which 9 is I don't think we need to worry about, you 10 know, making sure everything is right down to 11 the 40s and 30s and 50s of I.Q. 12 But I think it, and that's not to 13 say that I don't agree with your concerns 14 about the assumption of linearity. But I 15 think we see something quite like this down in 16 the range where kids in 70, 75, where they're 17 qualifying for special education. 18 And so I just want to temper the 19 comments about the range. I think 75 is a 20 level that is relevant for societal impact and 21 impact on the child. And we do have some data

22 relevant to that. Page 279

1 DR. KOSNETT: As long as we have 2 that figure up I wanted to add one other 3 observation on it. If you go down -- Can you

4 move the line to 16 so we can see Line 16? 5 And you notice it says, it's 6 referring to that graph. It says for small 7 changes in I.Q. or attention. For example, 8 small changes in I.Q. or attention are often 9 significant on a population basis. 10 And that presumes that this bell 11 shaped curve applies to the measures of 12 attention. We know that I.Q. follows this 13 nice bell shaped curve. 14 DR. WASSERMAN: The degree of the 15 inattention, if you're like on a five or a 16 ten, you'll either have it or you don't.

17 DR. KOSNETT: It doesn't follow a 18 bell shaped curve.

19 DR. WASSERMAN: It's not the more 20 inattentive you are, the more -- You are not 21 any more likely to be given a diagnosis of 22 ADHD. So you're right. It does not fall -- Page 280 1 DR. KOSNETT: So I was going to 2 ask you to revise that. I think it's okay to 3 use this bell shaped curve example for I.Q..

4 But I would delete the order and attention 5 part. Because I don't think it's the same 6 metric. You can't apply the bell shaped curve

7 to it. 8 DR. CORY-SLECHTA: Can I just say, 9 this is exactly why I don't think we should 10 use the diagnosis. If you go in and you look 11 at actual studies of children where they've 12 measured impulsivity or that, you do in fact 13 get graded responses. It isn't all or none. 14 And so hence, I disagree with you. 15 If it's diagnostic and it's yes or no, that's 16 one thing. But if I'm actually measuring 17 impulsivity or -- 18 DR. KOSNETT: Yes, okay.

19 DR. CORY-SLECHTA: -- 20 hyperactivity in a kid, I get graded 21 responses. They're not yes or no. 22 DR. KOSNETT: But have you looked Page 281 1 at the performance on some behavioral measures 2 in some of the epidemiological studies? They 3 don't, I don't believe that they fall in the 4 same kind of bell shaped curve that 5 intelligence does. 6 DR. CORY-SLECHTA: I think you 7 can, you know, my point is you get graded 8 responses. 9 DR. KOSNETT: Oh yes, yes. I 10 agree to be graded, but it doesn't necessarily 11 have to follow this nice bell shaped curve.

12 DR. WASSERMAN: And it would be

13 easier to talk about in attention if the

14 section on neurobehavioral effects 15 distinguished between inattention and 16 impulsivity, and a diagnosis of ADHD. 17 DR. KORRICK: And I just wanted to 18 add, it depends on the measure. There are

19 some continuous measures of attentional skills 20 that do have, that can be sort of normalized 21 to a sort of bell shaped curve. There are 22 some that are not. They're count data that202-234-4433 Neal R. Gross & Co., Inc. Page 282

1 have a Poisson distribution. But there are

2 measures.

3 And I think the fact that we're 4 sort of discussing this among ourselves is 5 very revealing of the challenges of 6 summarizing this literature, which is that 7 even the people who write, who do the studies, 8 oftentimes use the terminology sloppily. 9 That measuring sort of formal 10 psychometric tests that look at attention 11 scales or impulse control scales are very 12 different than making a clinical diagnosis of 13 ADHD. Even if some of those tests might be 14 used to make the diagnosis. And those issues

15 are blurred in a lot of the literature. 16 So when you're reading and 17 reviewing the literature, you have to be very 18 critical and make sure you understand what it 19 is they measured. And what it is you can 20 infer from it. And it's not always obvious

21 from the authors themselves. Because 22 sometimes these things get really muddled. Page 283 1 And anyway, I think the issue her 2 with this particular illustrative theory does 3 apply to some attentional behavioral measures.

4 And I think the issue is -- This is not 5 telling you necessarily what the dose response 6 for lead is at various I.Q.s. They're just 7 telling you what the distribution of I.Q. is. 8 And it's making an assumption that 9 distribution of I.Q. doesn't change, vary, 10 depending on lead level, which is probably 11 what the small changes -- That's probably not 12 unreasonable. So I think, and the same could 13 be said for other normally distributed 14 populations. 15 It's a different question than 16 what you're -- This is getting a different 17 theoretical issue. It's just looking at, all 18 that's there is a distribution I.Q.

19 DR. WASSERMAN: True. And it's 20 saying that we can move the entire

21 distribution down at the lower -- 22 DR. KORRICK: Well it's saying Page 284 1 that distribution doesn't change with 2 additional exposure. And as Michael said,

3 that's the issue. 4 DR. WASSERMAN: Right.

5 DR. KORRICK: You have to make the 6 assumption that the distribution of population 7 I.Q.s is independent of lead exposure.

8 DR. WASSERMAN: Yes. 9 DR. KORRICK: And all you need to

10 do is add a sentence to that effect. Because 11 I think that's the fundamental assumption of

12 this theoretical construct.

13 DR. WASSERMAN: And to demonstrate

14 that this is theoretical. 15 DR. KORRICK: Right. And if you 16 bind to that assumption this is a very 17 compelling argument. If you don't bind to 18 that assumption then it's a different issue. 19 But a lot of people believe that assumption. 20 And it's something that's been around for a 21 long time.

22 DR. WASSERMAN: But we don't know. Page 285 1 DR. KORRICK: I mean, this has 2 been around for 30 years. But, yes. 3 DR. CORY-SLECHTA: I think if you 4 go back, as I remember one of the original 5 citations of this was Bernie Weiss, who 6 published this. 7 And his intent was in fact to say 8 you would have less kids in the gifted range, 9 and potentially more kids moving below 70. 10 That's all it was. It never made assumptions 11 about anything. 12 And I think if you cite it the way 13 it was originally written it could avoid what 14 has become a discussion of, well you didn't 15 consider these assumptions. He clearly didn't 16 when he wrote this. He wrote it as a policy 17 piece basically. 18 DR. KOSNETT: Right. It was 19 Bernie, yes. 20 DR. FREY: Yes, Dr. Canfield.

21 DR. CANFIELD: Just to add on to 22 what Debbie was saying is that I think another202-234-4433 Neal R. Gross & Co., Inc. Page 286 1 point. And I think Bernie Weiss made this 2 point as well, which is that if you get -- 3 That the point here is that there's a 4 disproportionate change in the proportion of 5 kids in the lower and upper tails, as a result 6 of a say five percent change in the mean. 7 So if the mean changes five 8 percent, you actually get something like a 28 9 percent increase in the kids that fall below 10 75, given some assumptions. So it's that a 11 small change in the mean leads to a 12 disproportionately large change in the tails.

13 DR. KORRICK: Given some 14 assumptions.

15 DR. CANFIELD: Given some 16 assumptions. 17 DR. FREY: Okay. I think we've 18 discussed this from lots of angles. Are there 19 any other comments on Chapter 5? Anyone else? 20 DR. WASSERMAN: Oh, just one other 21 thing. Some of the figures, and this is not 22 really a science issue. I found them Page 287

1 differently captioned. So that not all the

2 abbreviations were well described at the 3 bottom of the figure. And in one instance I 4 went back to the original figure, which had 5 far, you know, many lines of text under it. 6 So somebody needs to be consistent 7 in reading through the figure, figurative, 8 figural material, to make sure that they're 9 all understandable. I know you don't want 10 eight lines of small print underneath each 11 one, but -- 12 DR. FREY: Well I happen to be a 13 fan of all figures should be self explanatory

14 and -- 15 DR. WASSERMAN: Exactly. 16 DR. FREY: -- actually should be

17 labeled. And there should be notes. 18 DR. WASSERMAN: Right. And no

19 abbreviations. 20 DR. FREY: And whatever the key 21 inputs were to find abbreviations. So that's 22 the gold standard I think. Dr. Canfield. Page 288 1 DR. CANFIELD: One other point. 2 On Page 5-112, where the mini mental state

3 examination is discussed. It's described as 4 a test of general cognitive function. And 5 that isn't, that's misleading. 6 It's really a screening test for 7 cognitive impairment. And so it's not an I.Q. 8 test or a test of general function. It's just 9 a screening for impairment. And I can go into 10 more detail if you like. 11 DR. FREY: Okay. One or two more. 12 Oh, I'm sorry. Dr. Rabinowitz.

13 DR. RABINOWITZ: If I can take a 14 few more seconds of your time. I think you 15 all appreciate we're all struggling trying to 16 figure out some way to help you with your task 17 of getting it better organized. 18 And with that in mind let me just 19 throw out an idea and see if it may help or 20 not. Looking at these different studies and 21 the confounding effects, some studies include 22 some confounders and others, others. Page 289

1 Anything to be gained by, as you 2 tabulate the studies, to present the raw lead 3 effect, and then the adjusted. After you 4 adjust for whatever the confounders are in 5 that study, the adjusted effect.

6 So the reader could look at the 7 magnitude of this. Does this confound mean a 8 big effect or is it a small effect? Does an 9 approach like that help? And I'll just leave

10 it there. 11 DR. FREY: Okay. 12 DR. KORRICK: I mean, I think 13 that's a good point. But it may not be

14 available in all the literature that was

15 reviewed.

16 I think the other issue that came 17 up related to that is that often times the 18 text would say, results were attenuated after 19 adjustment for X, Y, Z confounders. But the 20 P value was still significant.

21 And that's not -- It would be 22 nice in that setting to know how much it was202-234-4433 Neal R. Gross & Co., Inc. Page 290 1 attenuated. P values are integrated into a 2 lot of information. And effect magnitude is 3 just one piece of it.

4 So the fact that the P values were 5 still significant doesn't necessarily mean

6 that there's not still a concern about 7 residual confounding or, you know, that does -

8 - 9 If there's a large attenuation in 10 the main effect, that does suggest some more 11 measured interpretation of that study. And I 12 think that got kind of lost in the text. 13 DR. FREY: May I propose that we 14 deserve a break. We deserve a break today. 15 And we'll take a break until 3:50 p.m. And I

16 have the official U.S. time. So we will start 17 at 3:50 p.m. 18 (Whereupon, the above-entitled 19 matter went off the record at 3:35 p.m. and 20 resumed at 3:52 p.m.) 21 DR. FREY: Okay, folks. We, I 22 think, as a panel, have completed, more or Page 291 1 less, our discussion on Chapter 5. I would 2 like to try to get through Chapters 6 and 7 3 before we adjourn for the day; around 5:30. 4 I think it's pretty clear we're 5 not going to get to the preamble and executive 6 summary in Chapters 1 and 2 today, but we do

7 have a little bit of slack in the schedule

8 tomorrow. 9 So that actually may be good in

10 the sense that the discussants and the lead 11 discussants Chapters 3 through 7 have an 12 opportunity to reflect and, hopefully, send 13 some writeups tonight.

14 And that'll be beneficial to the 15 group that is discussing Chapters 1 and 2, and 16 the preamble, and the executive summary. 17 I think there's some follow-up 18 clarification that Dr. Vanderberg wanted to 19 offer on Chapter 5 and so I'd be happy to give 20 you the floor. 21 DR. VANDERBERG: Okay. Thank you. 22 I'd like to turn to Dr. Patel to make a point, Page 292 1 I guess, about the maternal issues.

2 DR. PATEL: Based on the comments 3 that we received on the first draft, we did 4 look into a potential confounding of lead 5 attention, ADHD-related behavior relationships 6 and how they were confounded by parental 7 psychopathology, and we included it, to the

8 extent that evidence was available.

9 We did include that in the

10 discussion of ADHD-related behaviors. 11 However, we'd like to add whether there is a 12 body of evidence that we're missing that does 13 support parental psychopathology confounding

14 that association.

15 We understand that it is an 16 important risk factor for the outcome in

17 children. However --

18 DR. CORY-SLECHTA: Can we not call 19 it psychopathology because I think that's the 20 wrong term. I think what Michael is referring 21 to is a genetic basis for ADHD rather more 22 than a psychopathology. Page 293

1 DR. WASSERMAN: It doesn't have to 2 be genetic. Parents with ADHD don't get their

3 kids to the doctor. 4 DR. CORY-SLECHTA: Either or, but 5 I mean, it's genetic, but psychopathology, I

6 think -- 7 DR. WASSERMAN: How about parental 8 behavior problems. 9 DR. CORY-SLECHTA: Something, yes.

10 DR. WASSERMAN: That's more

11 neutral.

12 DR. KOSNETT: I'm not wedded to 13 that term because in all that literature, and 14 I think it's safe to say, I've tried to review 15 it all, there are no studies that adequately 16 control for parental behavior. 17 Now, there are two studies that 18 you cite that said they controlled for 19 parental behavior, okay? And if you look at, 20 and I comment, and my written comments on it, 21 you know, one study was in Korea where they 22 asked the parents, have you ever had a202-234-4433 Neal R. Gross & Co., Inc. Page 294 1 psychiatric disorder?

2 And that was the basis for 3 controlling for parental. And less than 5 4 percent of the parents, by the way, said that 5 they ever did, which is probably implausibly 6 low, because it was any psychiatric disorder. 7 And the other one was the one by, 8 the remaining study, Nick Alusu, and they, 9 basically, just asked the parents, like Gayle 10 was saying, did you ever have ADHD, okay? 11 DR. WASSERMAN: Is there any 12 family history of behavior problem, right? 13 DR. KOSNETT: Yes. And then, in 14 the actual models that they showed in the 15 paper, they don't include the parental data. 16 But the narrative in the section says, these 17 studies have shown this effect, even those 18 including control for parental ADHD. 19 And I'm taking a more critical eye 20 towards it and, you know, diving into the 21 actual literature and saying that a critical, 22 you know, review of it would say that, Page 295

1 actually, you can't say that the appropriate

2 studies have been done.

3 And it's hard to do. If it was 4 easy to do it when you're doing an 5 epidemiological study, people would probably 6 do it, but it's hard to know if the parents 7 have had ADHD or behavioral problems.

8 DR. KORRICK: I'm not sure that's 9 what your -- I don't know. Your question is 10 really, what's the evidence that parental ADHD 11 is a confounder, not what literature looked at 12 it or didn't, right? 13 So I think in terms of that, 14 honestly, I don't know if there's direct 15 evidence, and others should speak up if they

16 do. I think it's based on the theoretical 17 notion that there's a strong familial 18 component to ADHD and that parents with 19 attention, or other ADHD-like difficulties, 20 have, probably, different parenting styles. 21 And that, those things could put

22 their children at increased risk for ADHD and Page 296 1 also, potentially, at increased for 2 contaminant exposures like lead. So I think 3 the reason for assuming that it's a likely

4 confounder is based on what's known about 5 familial propensity to ADHD and what's 6 potentially an issue for exposure risk. 7 But I'm not aware of any data that 8 definitively demonstrates that. So I think 9 that was your question, right? 10 DR. KOSNETT: No. I agree, Susan, 11 that's an important distinction.

12 DR. KORRICK: Yes. 13 DR. KOSNETT: Because they haven't 14 looked at it, you can't say it's a confounder, 15 but if you were going to look at this 16 literature and say, are you satisfied that all 17 the potential confounders have been adjusted 18 for to the point that we could say that the 19 finding is not due to confounding, with 20 reasonable confidence, I would have to say, in 21 the absence of controlling for parental 22 behavior, you don't have that confidence. Page 297 1 Particularly when your R-squareds 2 for the outcome are, like, 10 percent. 3 DR. WASSERMAN: So not having any 4 studies that address it one way or another is 5 a limitation of the existing literature 6 because there's this great big hole in our 7 understanding of the operation of the

8 confounders. 9 DR. FREY: Okay. John, does that

10 address --

11 DR. VANDERBERG: Yes. 12 DR. FREY: Okay. Great. All 13 right. I would like to go ahead with Chapter 14 6 and Dr. Cory-Slechta is the lead discussant, 15 and Dr. Canfield, and Dr. Wasserman, are the 16 co-discussants. And the floor is yours Dr. 17 Cory-Slechta. 18 DR. CORY-SLECHTA: I thought that, 19 in general, the revision document does a 20 pretty good job of addressing a lot of the 21 concerns that came up last time; that we

22 talked about it.202-234-4433 Neal R. Gross & Co., Inc. Page 298

1 It's been revised in terms of the 2 order presentation, which makes it more 3 palatable to follow. I still have one issue 4 with it. It came up with respect to Chapter 5 5 a little bit before, and I've brought this 6 up before, and that is that there's no 7 discussion of the magnitude of any of these 8 risk factors, and I find that really

9 difficult. 10 I mean, in terms of when we get to 11 risk assessment, how do we know, you know, are 12 these really important factors? Do they cover

13 the threes and ten factors that we throw on 14 top of a no AL or a low AL when we're talking 15 about at risk populations? 16 I think it would just be really

17 useful if we have some indication. Are we 18 talking about a genetic polymorphism that 19 produces a 1 percent difference in outcome, 20 you know, in terms of magnitude of an effect, 21 or is it 10, or 15, or 20 percent? 22 I get no sense from the chapter of Page 299 1 any of the magnitudes of the effect. I can 2 tell you that, in the neuroscience world, 3 there have been lots of editorials recently, 4 asking people, stop doing genetic polymorphism 5 studies, because the magnitudes of the effect 6 are so small as to be really meaningless in 7 many cases, unless you're talking about 8 disease that's caused by a gene mutation. 9 So some sense of the magnitude of 10 these effects, I think, would be very, very 11 useful, especially as you think about risk 12 assessment, which is, ultimately, where you're 13 going. 14 DR. FREY: Wow, that was brief. 15 Okay. Excellent. Dr. Canfield.

16 DR. CANFIELD: Yes. I had a

17 similar issue where I didn't feel like there18 was much contour to the importance or non19 importance of the various risk factors across

20 sections. Debbie said it much better than I 21 was planning to. 22 I was looking at an issue, it Page 300 1 actually comes up in Chapter 1 and 2, I guess, 2 that I was now looking for in 6 and I couldn't 3 find the place for it, but it was the issue 4 with children as being an at-risk population. 5 I felt this really is so minor 6 that there's a number of places in the 7 document where synaptic pruning from ages one 8 to four were somehow, I think, presented a 9 little bit too magically, or in too need of a 10 package, as, you know, this synaptic pruning 11 is really, you know, our bet as to where 12 things are happening. 13 And I just don't think we have the 14 evidence that the ages one to four are so 15 clearly, you know, the range that we're 16 concerned about and whether synaptic pruning 17 tells as much of the story as implied by the 18 text in a number of places. 19 DR. FREY: Okay. Great. Dr.

20 Wasserman. 21 COURT REPORTER: I'm sorry. Could 22 you turn your microphone on, please? Page 301

1 DR. WASSERMAN: Oh, I'm sorry. 2 Just again, that issue of equating maternal

3 stress in animals and lower maternal self4 esteem in humans, also appears in this 5 chapter. 6 There's another place, though, in 7 which, and I don't know if this is the only 8 place, there is discrepancies in the 9 literature cited about the directionality of 10 the risks. I'm thinking gender in particular, 11 Page 620, some studies are finding an

12 increased risk for males. 13 There's this paper on frontal lobe 14 grey matter loss and greater cognitive 15 deficits in a Polish cohort, and others find 16 greater risk for females, like in the Port 17 Perry studies. 18 And again, these are things that I 19 would view as red herrings. If you've got 20 inconsistencies in things that should be the 21 theme, like girls sometimes do worse and 22 sometimes boys don't, again, that should help202-234-4433 Neal R. Gross & Co., Inc. Page 302 1 you weight the evidence. 2 So if you add these things 3 together, plus the 40 unpublished studies in 4 which gender doesn't matter, probably, it 5 should help you evaluate, critically, the 6 degree to which gender is really important as

7 a risk factor here.

8 Yes. I'm done. 9 DR. FREY: Okay. Yes. Go ahead. 10 DR. CORY-SLECHTA: I guess I 11 disagree with you, Gail, you know, a huge 12 issue in neuroscience is gender differences 13 and I would highly expect there to be gender

14 differences in the different outcomes for

15 lead. 16 It would be one thing if you were 17 comparing exactly the same outcome, but 18 they're not. And I think, in the animal 19 world, gender differences are the rule and not 20 the exception. We could never put boys and 21 girls in the same group. They're clearly the 22 rule and not the exception. Page 303

1 So I think that most of the human 2 studies, some of them never even looked at 3 gender as an interaction factor, so I think

4 we've lost a lot of information from that 5 point of view. But, certainly, based on the 6 neurobiology, you expect gender differences to

7 be different for different outcomes. 8 So I guess I would take exception

9 to that. 10 DR. WASSERMAN: But these are, 11 very closely, the same, you know? I mean, in 12 Port Perry there are, like, I.Q. scores. In 13 Poland there are also I.Q. scores, but it --

14 DR. CORY-SLECHTA: But those could

15 be the result of other residual confounders 16 that differ by gender and culture, so I still 17 don't have a problem with that I guess. I 18 just think it tells us we need to understand 19 better what the different gender impacts are. 20 DR. WASSERMAN: Well, and then

21 there's all the other studies that don't find 22 any differences. Page 304

1 DR. CORY-SLECHTA: All of them. 2 There's not that many that actually looked and 3 parsed it out. That's been part of the 4 problem. 5 DR. WASSERMAN: Well, then maybe 6 that just needs to be highlighted.

7 DR. CORY-SLECHTA: Yes. 8 DR. FREY: Okay. We're open to 9 other panelists. Dr. Kosnett.

10 DR. KOSNETT: I didn't delve into 11 the weeds of Chapter 6, but there's a section 12 of Chapter 2 which refers to the populations 13 at risk that there were two things that caught 14 my eye and I thought it would be worth 15 bringing up. 16 One is, and this is on Page 2- 17 7(a), and it has the statement in here about 18 exposure. You know, you're being at risk if 19 your co-exposed to lead with metals and 20 chemicals. And it has a very provocative

21 statement in here. 22 It says, "Since lead is acid Page 305 1 soluble, fluoridation may increase lead 2 concentrations in water through leeching from 3 pipes and lead solder." And I thought, wow, 4 that is a very provocative statement because

5 it's EPA. 6 In an EPA document they're 7 implying that fluoridation of water supplies 8 could increase lead exposure. Now, everyone 9 knows that fluoridation is controversial among 10 certain segments of society. 11 And if they felt that this

12 sentence from EPA validated concern about 13 fluoridation, it would be on the news. And, 14 you know, I went and looked at the section 15 that it refers to, 4.1.33, to say, well, where

16 did that come from? 17 And there's one study that they 18 cite where they took brass fixtures and they 19 put it in vitro in a tub, and they measured 20 the amount of the lead leeching out of the 21 brass, and then they added fluorosilicic acid 22 to it, and then they measured the202-234-4433 Neal R. Gross & Co., Inc. Page 306

1 concentration of lead in the water.

2 So it was brass fixtures and it 3 wasn't a measure of water at the tap, and it 4 had no effect on pipes, and there's no 5 literature that says that fluoridation 6 actually increases lead exposure through 7 drinking water systems in actuality. 8 I actually checked with one of our 9 colleagues who's published a lot of work on 10 lead and drinking water. And I said, you 11 know, is this kosher? And he had concerns too

12 that this went too far. 13 So I hope you can just take that 14 out in a hurry. 15 DR. FREY: Dr. Canfield, I think,

16 has a relevant comment.

17 DR. CANFIELD: Yes. There is one 18 peer-reviewed paper from mid-last decade and 19 it's not a patriot group or anything like 20 that, but there was something of a crusade and 21 someone who really did, in neurotoxicology, 22 got a peer-reviewed paper in on different Page 307 1 forms of fluoridations, you know, systems and 2 blood lead levels, and age of housing. 3 I mean, so I wouldn't agree with 4 you that there's nothing out there, but it 5 should be cited in this place, and I can 6 provide you with the reference to it if you're

7 interested. 8 DR. KOSNETT: Okay. Yes. 9 DR. CANFIELD: I mean, I'm not

10 sure I believe it. And it's not an individual 11 child measure. It's more of a, you know, 12 group and county kind of analysis. 13 DR. KOSNETT: Yes. Well, that's 14 interesting, but that wasn't cited in here, so 15 I didn't go -- 16 DR. CANFIELD: Right. I remember 17 when I read through I was thinking that I was 18 going to go back and look for that paper, but 19 I didn't at that point.

20 DR. FREY: Let's see. Dr. Johnson 21 and Dr. Cory-Slechta.

22 DR. JOHNSON: Yes. This seems to Page 308 1 me just a little misleading. I mean, if 2 hydrochloric acid of the same concentration 3 would have the same effect, right? There's 4 nothing specific, I think, about the fluoride 5 part of that that causes this release of lead. 6 So I mean, I think it's a red 7 herring and the concentration of fluoride 8 that's used in drinking water systems is not 9 enough to change the pH substantially anyway.

10 I think it doesn't make sense to have that in 11 there. I think you're just asking for

12 trouble.

13 DR. CORY-SLECHTA: Yes. It's not 14 in Chapter 6, so it only, at least I didn't 15 see it, appears in Chapter 2. So I'm not 16 quite sure how it turned up there and not -- 17 unless it's someplace else in the document 18 that it's referring --

19 DR. KOSNETT: It's cross20 referenced in 4. 21 DR. CORY-SLECHTA: What? Oh, 4, 22 okay. Page 309

1 DR. KOSNETT: It cross-references 2 in Section 4, but in Section 4, they just have 3 that one in vitro study. 4 DR. CORY-SLECHTA: Right. Okay.

5 DR. FREY: Other comments on 6 Chapter 6? 7 DR. KOSNETT: There was just, in 8 that same paragraph that, something about 9 exposure to arsenic, and lead, and cadmium, 10 mixtures, and it cites an article by Wang and

11 Fowler on the mixtures.

12 And I read that article and I 13 don't think that article says that. So I

14 think that that should be revisited. That's 15 the citation in Section 6.1; Wang and Fowler. 16 DR. FREY: Okay. Any other 17 comments; Chapter 6? Maybe we're going faster 18 than I thought. Maybe we will get to some of 19 the Chapter 1 and 2 before the end of the day. 20 Okay. Well, seeing no further 21 hands for Chapter 6, let's go ahead to Chapter

22 7 and the lead discussant is Dr. Roman Lanno202-234-4433 Neal R. Gross & Co., Inc. Page 310 1 and the co-discussants are Dr. Allen, Dr. 2 Johnson, and Dr. Stubblefield. And so, Dr. 3 Lanno, the floor is yours. 4 DR. LANNO: Great. Thanks, Chris. 5 I think it's a consensus that the chapter was 6 greatly improved with the additional content 7 and the organizational structure was changed

8 to make it much more readable. 9 And within each section, the 10 addition of reference to previous AQCD 11 documents really helped, kind of, frame what 12 had happened since the last revisions, and 13 actually, it went right through three or four 14 of the documents, so I would say it's a good 15 historical account of what was going on. 16 And the summary at the end of the 17 chapter has really provided a good idea of

18 what had been discussed in that section. And

19 a lot more of the more recent literature was

20 added to it. 21 And organization, one of our

22 concerns was to break out the fresh water Page 311 1 marine sections and discuss them separately 2 because of the very different environmental 3 chemistry in those two systems, and that was 4 accomplished quite nicely. 5 So kudos for the organization and 6 making it much easier to read. So to follow 7 that up, although you've got new information 8 and it's organized, one thing that the chapter 9 could benefit from is, I think, a good summary

10 of all the data that's there. 11 And I saw that, in a previous, I 12 think it was a 2006 AQCD, they have an annex, 13 or an appendix, of data. I never did look at 14 that, but that would seem like a very good 15 place to summarize a lot of the information so 16 that you can take a look at it and try to make 17 sense of all the exposure concentrations that 18 exist for the various organisms that are 19 exposed. 20 And having said that, since this 21 is an integrated science assessment, taking 22 that data further and summarizing it into a Page 312 1 meaningful synthesis. This is not going to be 2 an easy, I don't think, but I think it has to 3 be attempted. 4 So summary tables that would list 5 these media-based concentrations, so the 6 concentrations of lead in soil, or water, 7 whether it be marine or fresh water, and with 8 the respective responses and the key abiotic 9 modifying factors, so looking at pH, or 10 cationic exchange capacity, organic carbon in 11 soils, pH dissolved organic carbon, and water 12 hardness in aquatic systems. 13 I think you put that all into one 14 big data table, or into an annex, it would 15 really help, kind of, get a bigger picture on 16 what data was available and what the modifying

17 factors were. 18 And also, so to take that further, 19 once you've got the tables, a discussion of 20 who these concentrations are actually related 21 to effects in the various systems.

22 So if we could have an initial Page 313 1 discussion of some of the very high levels 2 that are there, and in many of these studies 3 there are very high levels of lead, which, 4 really, are not environmentally very 5 meaningful, although they generate part of the 6 dose response in the laboratory setting. 7 It'd be nice to, kind of, talk

8 about the relevance of those doses. And at 9 the other end of the scale as well, I think 10 Dr. Allen had found a few places where there

11 were some concentrations of lead that were so 12 low, the question is, how could they ever have

13 been measured? 14 And if they're that low, do they 15 provide any kind of a meaningful addition to 16 the dose response relationship that's seen? 17 And that was going to lead into some of the 18 other questions or comments that we have as

19 well. 20 And then, finally, if you have all 21 these response to the different 22 concentrations, you have a nice table that's202-234-4433 Neal R. Gross & Co., Inc. Page 314 1 setup in Table 2.1 where you've outlined the 2 range and the meanings for the various 3 concentrations of lead in the various media, 4 so in soil, and in sediments, and fresh water,

5 and marine environments. 6 And so to, kind of, overlap the 7 meaningful exposure concentrations with those 8 environmental concentrations to give us a 9 context of, could that effect happen in the

10 real world? 11 Now, there are many, many other 12 factors, such as bioavailability, that are 13 going to affect that outcome, but I think if 14 we could get an initial mapping of the two 15 ranges of data, the expected environmental

16 concentrations and the concentrations at which 17 we see effects in laboratory settings, that 18 would at least give us some better context of 19 how to interpret the results, because this is 20 a wide range of results. 21 I mean, why wouldn't you have 22 concentrations and responses? And it's very Page 315 1 difficult to bring it all together, but that 2 would be a good first attempt at a synthesis

3 of the data. 4 And I guess, second point to 5 follow up on that is, just how the expression 6 of the exposure dose occurs in your document. 7 And one thing we had talked about for the 8 revisions for this document was, consistency 9 of expression of exposure dose. 10 So I know in some paragraphs we've 11 got milligrams per kilogram and micrograms per 12 kilogram in the same sentence. And although 13 you can flip back and forth with that very 14 nicely, if you throw micromolar in there, then 15 it's all of a sudden you're doing all this 16 math to figure out what's going on. 17 And so it would be nice, in some 18 way, if you could set that up so that it's 19 relatively constant. I don't think you want 20 to be taking the micromolar values out, but 21 perhaps, in a bracket, you could put what that 22 is in micrograms per liter. Page 316

1 If that's the concentration that's 2 usually found in surface waters, then that 3 would facilitate a good comparison.

4 And further on to that effect 5 about exposure dose, it wasn't clear, to me at 6 least, in how many of these were we actually 7 talking about nominal concentrations or

8 measured concentrations of lead? 9 And in the case of nominal, I'm 10 assuming when you had, you know, 10, a 100, a 11 1000, that's all nominal and I don't know if

12 that was measured or not. And in most of the 13 U.S. EPA -- well, in all the U.S. EPA water 14 quality criteria development process, nominal

15 concentrations are not used. 16 So, you know, we have to find out

17 what the measured concentrations are and I 18 think it's just better to report those if they

19 exist and dismiss the nominal concentrations.

20 Don't include them. 21 And in some of these cases, you 22 may only have nominal concentrations. I don't Page 317 1 know how the data got published then, but that 2 happens. So that's something to consider as

3 well. 4 It could be old data, although, 5 these are the more recent publications. But 6 anyway, a third consideration for expression 7 of dose is what the medium actually is. And

8 there are situations when we talk about 9 effects on terrestrial plants where the actual 10 exposures to lead occurred in hydroponic

11 culture. 12 So it's not actually in soils. It 13 could be construed as soil poor water, but 14 it's not even the soil poor water. It's a

15 mixture of various salts. I'm not even sure 16 what goes into a hydroponic mixture. 17 But a mixture of salts, and then 18 the lead would be added, and then you'd 19 incubate the plants exposed only to the 20 aqueous medium and not in contact with any 21 soil, which is a very different exposure 22 scenario than in the real world because you202-234-4433 Neal R. Gross & Co., Inc. Page 318 1 have different physiological adaptations of 2 the plants to the water medium. 3 In fact, they don't develop root 4 hairs and such, they kind of get lazy I guess.

5 You don't have to find water in the soil. 6 They're already exposed to it so their 7 physiology actually changes. 8 So I think if you could point that 9 out at least and then maybe consider those 10 types of studies as more supporting than 11 direct evidence for lead dose responses in 12 soil systems. 13 Another example would be the tests 14 that were conducted with nematodes, C. 15 elegans, where I think they were expressing

16 concentration of lead on a micromolar basis or 17 on a micrograms per liter basis, which would 18 tell me that it was probably conducted in an 19 agar solution, or some other type of solution, 20 and not actually in the soil. 21 And again, it's the same type of 22 thing. The organism in the soil responds Page 319 1 quite differently than an organism exposed in 2 an aqueous system if it's a soil organism. So 3 to point all those out would be, I think, 4 quite useful in interpreting some of that data

5 further. 6 The endpoints that they use in the 7 assessment. So there's a whole range, 8 obviously, from suborganismal-like enzyme 9 level, or gene expression endpoints, to whole 10 organism responses, then, of course, take that 11 to community and population levels.

12 And we'd like to be able to take 13 it at least to the population levels because 14 that's the point at which we, kind of, try to 15 regulate when it comes to the ecological 16 receptors. So we'd like to at last have a 17 whole organism response. 18 And in the U.S. EPA water quality 19 criteria development, the major endpoints we 20 use, we'd like to use a reproduction, and 21 probably growth, and sometimes lethality as 22 well, if there's no chronic data. Page 320 1 But the suborganismal expressions 2 of response, they have to be used with caution 3 because they often don't translate into whole 4 organism responses, and therefore, population 5 effects. And so that should be spelled out 6 clearly as well. 7 And so the relative importance, I 8 think, that if you have an enzyme expression 9 and you have a reproductive endpoint, like 10 numbers of organisms reproduced, that's got to

11 be a balance because those two numbers don't 12 carry the same weight in interpreting 13 ecological effects. 14 So some balancing the expression 15 of what the endpoints actually are would be

16 useful as well. 17 And finally, I've got here, this 18 whole issue of causal determination, to follow 19 up what Dr. Kosnett was saying earlier, and 20 how we interpret this. I'm not quite sure 21 where we're going with this. 22 So we have a situation where, in Page 321 1 the lab, we have a dose response and I guess 2 that is causal if you can say that the lead is 3 causing the effect that we're seeing, but how 4 does this actually relate to the aerial 5 deposition of lead in causal determination, I 6 don't quite understand, or is that even the 7 goal of the causal determination? 8 Does that capture that, Bill? 9 Yes? So, yes, we'll probably boot that around 10 a bit more here. So, you know, exactly, I 11 mean, I guess the question becomes, in the 12 terms of an ecological receptor, what does 13 this causal determination actually mean? 14 And there's a few paragraphs here 15 in Chapter 2, I'll go to Chapter 2 for a 16 second, if I read the sentence, "The 17 proportion of observed effects of lead 18 attributable to lead from atmospheric sources

19 is difficult to assess due to a lack of 20 information, not only on bioavailability as 21 affected by the specific characteristics of 22 the receding system, but also on deposition202-234-4433 Neal R. Gross & Co., Inc. Page 322

1 and on the kinetics of lead distribution in 2 ecosystems in long-term exposure scenarios. 3 Therefore, the connection between 4 the air concentrations and ecosystem exposure 5 continues to be poorly characterized for lead 6 and the contribution of atmospheric lead to 7 specific sites is not clear." 8 So I think we really have to make

9 a clear distinction as to what the causal 10 determination actually means and also is that, 11 how can we relate atmospheric lead deposition

12 to effects in different matrices? 13 And I understand that, in the lab, 14 you're going to amend your matrix with lead at 15 a certain concentration and get a response, 16 but that link between aerial deposition and 17 what actually winds up in that matrix, I 18 think, is very important to define somehow. 19 I think that's all I've got for 20 now. I think I'll pass it on. 21 DR. FREY: Okay. Great. Thank 22 you. Dr. Allen. Page 323

1 DR. ALLEN: First of all, this is 2 so much improved over the previous version 3 that they're just light years apart. This is 4 really far better. It is easier to read. 5 There is more synthesis. There's more 6 guidance to the reader. All of the things 7 that Roman has already said, I would like to 8 reiterate in spades. 9 You're really to be congratulated.

10 You did a lot of work since the last time. 11 With that said, all right, let me go back to 12 one of the things that Roman talked about and 13 then amplify on that.

14 And this is in the units of 15 concentration. For people who don't work a 16 lot with chemicals, it is very difficult for 17 them to switch back and forth between weight

18 units and molar units. 19 They see numbers. They look at 20 the magnitude of the numbers and not the units 21 that are behind them. And you'll have a 22 paragraph where you talk about some response, Page 324 1 you know, and the first study will be in 2 micrograms per liter, and the next one will be 3 in micromoles per liter, you know, with 4 nothing in there that tries to give the reader 5 some help. 6 So you really give the reader the 7 help that they need, which is to take -- most 8 of the people are used to working in weight 9 units, although they shouldn't be, but that's 10 a different story, and so I would put, behind 11 all of the molar units, in parentheses, the 12 value in weight units. 13 And don't carry them out to 14 extreme numbers of decimal points, round them 15 off. They were rounded off to begin with. 16 Now, when I look at some of those numbers, I 17 looked at one sentence in there and I said, my 18 God, how in the world did they possible do

19 this? 20 And I commented on that. They ran 21 a study with lead at 10 to the minus 12th 22 molar. Now, analytical chemists talk about Page 325 1 lead being sticky and it is very, very 2 difficult. It sticks to everything. It's 3 hard to get off, so on, and so forth. 4 10 to the minus 12th molar, wow. 5 Congratulations. Then I read the paper and 6 you screwed up. The lowest level isn't 10 to 7 the minus 12th molar, they ran values as low

8 as 10 to the minus 15th molar. 9 Now, 10 to the minus 15th molar, 10 to put it into some perspective, years ago, 11 you know, the person who really started a lot

12 of the lead business was C.C. Patterson. And 13 Patterson's laboratory ran the best clean 14 laboratory in the world and everybody checked 15 against Patterson's, and if you didn't check 16 against Patterson, your results weren't any 17 good. 18 Just de facto; no good. He ran, I 19 remember, deep ocean leads which were the 20 water should have been the least effected by 21 any anthropogenic input. Those were, as I 22 remember, a couple of nanograms per liter.202-234-4433 Neal R. Gross & Co., Inc. Page 326 1 That's about six orders of magnitude higher 2 than what these people ran. 3 I don't know how you did it. On 4 top of that, then I looked at this. This was 5 a study on estrogenic effects and so the human 6 health people pay attention. The lowest 7 levels that are being reported for health 8 effects, if an estrogenic effect is considered 9 a health effect, is in this paper, not in 10 cognitive things. It's in estrogenic effects. 11 We have an estrogen here, which is 12 the most -- I don't work in the field, I see 13 a number of papers in the area, but as far as 14 I can tell, it's the most estrogenic substance

15 that's ever been found. 16 Some point to be taken, I think 17 there's something wrong. And I think that 18 it's important enough, because the numbers are 19 so small, that somebody can take this and run

20 with it. 21 And so I've pointed out two that 22 have really low numbers. This one is even Page 327 1 lower and I was surprised when I got to it 2 because it was two orders of magnitude lower 3 than the previous one, then I get to this one, 4 you know, and it's really low, then I look at 5 the paper and it's even lower? Check them. 6 And check them and put in whatever 7 caveats you want to put in; take them out. I 8 would rather see them in and then something 9 said about them, otherwise, somebody else is 10 going to come up with it and draw a

11 conclusion. 12 And so I think one of your 13 services ought to be to say something critical 14 about studies that need to be said something

15 critical about. That's one. 16 Let me go back. I have one last 17 comment and that, again, is on the weight 18 versus molar values. In many types of 19 studies, it doesn't make any difference 20 whether you compare things on a weight basis 21 or on a molar basis, you reach the same

22 conclusions. Page 328 1 This number's higher, this 2 number's lower, you get an effect at this 3 level, and so on. However, when you start to 4 consider chemical processes, and you start to 5 consider one metal versus another metal, and 6 there are chemical processes involved, you can 7 only look at them on a molar basis. 8 And you have looked at them on a 9 weight basis. And you drew the conclusion

10 that in assessment of critical loads that lead 11 was ten times less than were the other metals, 12 which were probably, copper, nickel, and

13 cadmium come to mind. 14 However, you know, if we remember 15 back to freshman chemistry, atomic weight of 16 lead is 200, atomic weight of cadmium is 100, 17 and everything else is 50, plus or minus a 18 little bit, so you have one to two to four.

19 Lead is about three to four times 20 that of copper and nickel, and therefore, the 21 number is not tenfold higher, but threefold 22 higher. Threefold falls apart in our ability Page 329 1 to model these things; tenfold does not. 2 And so what you reach in a 3 decision depends upon how you actually do that 4 assessment. And so when you consider 5 chemistry, please look at molar 6 concentrations, not weight concentrations. 7 Thank you. 8 DR. FREY: Okay. Dr. Johnson. 9 DR. JOHNSON: I have very few

10 comments on this. I think Roman did a nice 11 job of looking at all of our pre-meeting 12 comments and putting together a nice summary. 13 So, basically, in terms of -- and 14 also in this particular chapter there weren't 15 that many charge questions, so the two notable 16 additions to this chapter, I thought, were the 17 additional discussion of ecosystem receptors 18 and the biotic ligand model, especially with 19 regard to the terrestrial systems portion of 20 the chapter.

21 And also the increased discussion 22 of ecosystem services. The discussion of the202-234-4433 Neal R. Gross & Co., Inc. Page 330 1 ecosystem services, you know, I think, takes 2 a pretty narrow view of ecosystem services. 3 Perhaps that's necessary for what you're 4 trying to do. 5 You know, one of the things, as I 6 mentioned in this meeting last July, is that, 7 you look at soils, for example, and they 8 provide ecosystem services in terms of growing 9 crops and things like forest, wood fiber, 10 things like that, which is, sort of, what 11 you're focusing on here, but they also 12 provided ecosystem service in the sense that 13 they prevent metals, like lead, from ever 14 reaching aquatic systems. 15 So, you know, that's a bad thing, 16 potentially, for the crops that are growing on 17 the soils, but is a good thing for the aquatic 18 systems that these terrestrial systems 19 ultimately deliver water to. 20 And that, I guess, leads to a 21 larger question that I also raised previously, 22 which is that, you talk about terrestrial Page 331 1 systems, you talk about aquatic systems, 2 there's really very little, if any, discussion 3 of the linkages between terrestrial and 4 aquatic systems. 5 How you would do that in the 6 context of an ecological risk assessment, you 7 know, I'm not sure that that's an easy task to 8 do, but it is an important linkage that

9 deserves some consideration. 10 Other than that, I think the 11 discussion of critical loads, I have to read 12 this some more. When I make my final 13 comments, maybe I'll bring it up, but I'm 14 interested to hear what other people have to 15 say.

16 It sort of seems like the critical 17 loads is kind of halfway. You don't really 18 embrace it, certainly, as a decision-making 19 tool. At the same time, you don't discard it 20 entirely and not even talk about it, so I

21 haven't decided how I feel about whether 22 you're really gaining anything by bringing Page 332

1 that whole critical loads discussion into this 2 document the way that it is. That's all I

3 have. 4 DR. FREY: Okay. Thank you. Dr.

5 Stubblefield. 6 DR. STUBBLEFIELD: Thank you. I 7 should start like my colleagues have all 8 afternoon and congratulate you on the 9 increased quality of the document. It really 10 is a substantial improvement in the overall 11 readability and content of the document. 12 I also will keep my comment very

13 brief because I think that Dr. Lanno had 14 pulled together an excellent discussion of the 15 points that were provided as Chris just

16 indicated. 17 There's a couple of things that I 18 would bring up. One of them is just a comment 19 in passing, and that is that, although there

20 is a substantial amount of new information 21 that is added to this document, the previous 22 document had relied substantially on old Page 333 1 science; that was pointed out. 2 It was 1984 and older work, but 3 this one has brought in a great deal of newer 4 published data. The one thing that was 5 mentioned in the past comments that we 6 provided was that there is a substantial 7 amount of industry information that has been 8 generated. 9 And if I recall correctly, it was 10 offered to EPA by industry representatives 11 that they could have access to that data if 12 they so desired. And I guess that EPA never 13 went after it. But when I go through the 14 document and I read comments like, well, 15 there's no saltwater growth fish data, I know

16 that that's incorrect.

17 There are data that are available

18 and I think that it would be made available if 19 it was accepted by the agency. So to that 20 extent, I would reiterate that comment. 21 Other things, I think Roman hit

22 the nail on the head for me as far as the202-234-4433 Neal R. Gross & Co., Inc. Page 334 1 issue of causality. I really don't know what

2 that means. 3 I've gone through the document and 4 in every case, the conclusions that are 5 reached almost always have a form that, 6 basically, they all end in a sentence that 7 says, the evidence is sufficient to conclude 8 a causal relationship between lead exposure 9 and something, like physiological stress in 10 plants, and vertebrates are vertebrates. 11 And I don't know what you mean by 12 lead exposure. And so in going through the 13 document, I tried to get a better handle on 14 what is meant by that. And there is one 15 section in the document, I believe it is 16 7.4.26, "Survival of Aquatic Biota".

17 And there's a sentence in there 18 that says, "Freshwater biota that exhibits 19 sensitivity to lead in the range of lead

20 concentrations measured in U.S. waters 21 includes some species of gastropods, 22 amphipods, cladocerans, and rotifers although Page 335 1 the toxicity of lead is highly dependent upon 2 water quality variables such as DOC, hardness 3 and pH." 4 The form of that sentence suggests 5 to me that there is a comparison of reported 6 toxicity values to measured environmental lead 7 concentrations. And this almost, to me, 8 sounds like an ecological risk assessment,

9 which makes sense. 10 However, the other sections do not

11 relate the observed effects concentrations to 12 any kind of environmental concentrations. So 13 I don't know if they're real or not. And so 14 I don't really know what a causal relationship

15 is. 16 Are you trying to evaluate the 17 lead exposures that result from atmospheric 18 deposition of lead on potential receptors or 19 are you trying to just say that, in laboratory 20 studies where I wallop the heck out of them 21 with X doses of lead, I can see this effect? 22 And if that is the case, then you Page 336 1 have to do something to try to tie the two 2 together. So if the bottom-line is to try to 3 get some kind of indication of whether 4 atmospheric concentrations of lead are 5 resulting in adverse effects on receptor 6 organisms, and I think that's really 7 important. 8 And then the last thing, and Roman 9 mentioned it as well, and that was the 10 question of, what I will call, non-traditional 11 endpoints. Traditional endpoints that are 12 used for things like ambient water quality 13 criteria are always limited to survival growth 14 and reproduction.

15 That's because we don't know what

16 to do with behavioral data. And we don't know 17 what to do with enzymatic data or genetic 18 sorts of endpoints. And we don't know how to 19 relate that to population level kinds of

20 effects.

21 And so until we can establish such 22 relationships, we typically do not take those Page 337 1 things into consideration in establishing 2 criteria. I'm not saying that it shouldn't 3 be. I'm not saying that this isn't achieving 4 what you want. 5 But it does set a precedent that 6 you should be mindful of, because if, in fact, 7 you are acknowledging that this is real 8 effect, then I would suggest that the Office 9 of Water needs to go back and rewrite their 10 criteria to take into consideration; enzymatic 11 effects, or neurological effects, or 12 behavioral effects, or whatever. 13 And I think that the agency needs

14 to be mindful that that is a decision that is 15 being made by going forward in this fashion.

16 That's it. 17 DR. FREY: Okay. Thank you. 18 Other comments on Chapter 7? Yes, Dr.

19 Rabinowitz.

20 DR. RABINOWITZ: First I need to 21 confess that I did not read the chapter. It 22 was just quickly once-over. But I just had202-234-4433 Neal R. Gross & Co., Inc. Page 338 1 two questions; really. Did it appear in the 2 chapter, would it be useful to appear in the 3 chapter, some expression, for those outside of 4 that world, to list the most sensitive 5 species?

6 Was that there? Did I miss it? 7 Would it be useful? I mean, like a miner's 8 canary, that kind of thing. Is there 9 something when birds start falling out of the 10 trees? I mean, what's our tip-off that 11 there's too much lead in the environment, any 12 way, enzymes, or whatever; bodies. I just

13 want the most sensitive. 14 Secondly, Bill, I like your idea 15 of getting all the information we can to fill 16 in the blanks, like, lead in saltwater, but I 17 don't know, has there been some ruling or not, 18 that we can only use published data in peer 19 review journals? 20 DR. FREY: Yes. Actually, that's 21 discussed in the, I guess, John, you can 22 correct me whether it's the preamble, but yes, Page 339 1 there's a pretty clear definition of, you 2 know, peer review literature or, I think, it's 3 data that, maybe, EPA has collected and it's 4 gone through quality assurance. So there is

5 a threshold. 6 DR. RABINOWITZ: Somebody needs to 7 address the question whether or not this 8 potentially useful data does meet that 9 threshold. I'm not prepared to do that. 10 DR. FREY: Other panelists; 11 questions; comments? I saw, I think, Mary

12 wanted to make a comment on behalf of EPA. 13 DR. ROSS: Well, the question has 14 come up about the causal determinations and 15 what they mean. And maybe what we can do is 16 bring some of the preamble and introductory 17 materials closer to Chapter 7 because it's 18 very similar to the health effects 19 determination where we're integrating evidence 20 biologically, but not really linking it saying 21 causal at a particular concentration. 22 But it's intended to integrate the Page 340 1 information from the field studies, the 2 laboratory studies, what's known about 3 biological mechanisms, to determine if there

4 is credible evidence that indicates that 5 there's a causal relationship between lead 6 exposure, through any medium, and the outcome. 7 And it can be a challenge, just 8 like it is in human health, to determine how

9 much of that is related to air versus other 10 imports. So the causality determinations here 11 are very similar to those in the health

12 outcomes. 13 They're not specifically saying 14 air and they're no specifically saying a 15 specific concentration. We do try to focus on

16 the concentrations in the whole evaluation 17 that are, what we call, relevant. They're

18 closer to environmental concentrations. 19 We use a term, sort of a term, of 20 one to two orders of magnitude as, sort of, a 21 general rule of thumb, but we tend to look to 22 see what might be relevant in terms of mode of Page 341 1 action. Really high concentrations can cause

2 a different effect than the more environmental

3 concentration. 4 So I just wanted to bring in, that 5 was the intent and obviously it wasn't clear. 6 So that's something we could -- right, so in 7 Chapter 2 -- 8 DR. KIRRANE: Page two, you've 9 probably seen it, so I don't mean to suggest 10 that it's adequate, but there's a paragraph on 11 Page 2-3, you may have seen it, but just in 12 case you missed that, it kind of lays out what

13 we did. 14 DR. ROSS: But we could bring that 15 back into Chapter 7 too.

16 DR. KIRRANE: Yes. 17 DR. ROSS: And they're a long ways 18 apart. 19 COURT REPORTER: I'm sorry. Could 20 you use the microphone?

21 DR. ROSS: So we'd be interested 22 in what would be helpful in making it clearer,202-234-4433 Neal R. Gross & Co., Inc. Page 342 1 obviously it wasn't clear, in how the causal 2 determinations are made, but some of the early 3 information could also be brought into Chapter

4 7 to be closer to the evaluation too. 5 So just wanted to bring that up. 6 DR. JOHNSON: No. I appreciate 7 that and I have looked at, specifically, that 8 paragraph, which I found interesting because 9 the first sentence is, "The causal statements 10 for terrestrial and aquatic effects are 11 arranged according to ecologically meaningful 12 levels of biological organization; organism, 13 population, community, and ecosystem." 14 And then you go on down, and when 15 you actually present it, then you start 16 talking about effects on enzymatic levels of, 17 here it is, "Lead, physiological stress, 18 hematological effects, neural behavioral 19 alterations, all may decrease the overall 20 fitness of an organism, even though the 21 connection to effects at higher levels of 22 organization may not have been characterized." Page 343 1 So, to me, it sounds like you're 2 acknowledging that the organismal level is 3 probably the bottom level that you're 4 considering, which is typically consistent 5 with survival growth and reproduction kinds of 6 endpoints. 7 But then you come back and you 8 look at all of these other physiologic stress 9 and other non-traditional endpoints, if you 10 will, and you say, but these can contribute to 11 affecting this organism, which, the way I read 12 into that, and I don't have any issue with you 13 saying that, but just be aware that when you 14 say that, what you're saying is that, those 15 kinds of endpoints really are important. 16 In that, they are attributable to, 17 in this case, lead, and so therefore, you 18 should be setting your evaluation standard on 19 the basis of those endpoints.

20 DR. ROSS: Can I ask one more 21 question?

22 DR. JOHNSON: Please. Page 344 1 DR. ROSS: So again, thinking 2 about the health effects, because I am 3 actually a health effects person, the 4 equivalent would be using small physiological 5 changes, not so much as the endpoint 6 themselves perhaps, but as part of the adverse 7 outcome pathway, or the mode of action, 8 considering the effects that are seen, and 9 then drawing the conclusions relevant to the 10 bigger picture. 11 These small effects may be part of

12 the chain of events that results in an 13 organismal chain. And, you know, if that is 14 useful, if we could set that up, as a way to 15 better explain how we're putting the 16 information out, not so much that each 17 individual outcome is, in itself, a clinically 18 observable effect, but it might be part of, 19 this is a question, part of an ecological 20 pathway that results in effects down the road. 21 DR. JOHNSON: I agree that it may 22 setup a pathway of effects, but in many cases, Page 345 1 for example, let's go away from lead for a 2 half second, just because I don't want to play 3 with that given the topic, but let's talk 4 about, say, PAHs. 5 An organism gets exposed to PAHs

6 in the environment and what is the normal 7 response that would occur with that? Well, 8 you'd have induction of CYP1A and that would 9 cascade to, you know, basically, some people 10 would look at that as if it's a compensatory 11 response. 12 It's a response that your body had 13 best be doing if it's being exposed to PAHs so 14 that you can metabolize and eliminate those 15 materials. But it could also lead, if you 16 overwhelm that capacity it could lead to 17 adverse effects, or that metabolism may, in 18 fact, lead to adverse effects in and of

19 itself. 20 But the problem is that if you 21 look at that, you can say, I exposed the 22 organism and I got a response. And that202-234-4433 Neal R. Gross & Co., Inc. Page 346 1 response is probably, or could lead to, a bad 2 outcome. So if that's the case, there are 3 many people out there who would say, you need 4 to regulate to protect that you don't have 5 those kinds of responses. 6 And so, I mean, this is an 7 argument that has gone on for years and years 8 in terms of how you interpret the data. So 9 that is why everybody in the past has stopped 10 short of looking at lesser levels of 11 complexity than at an organismal level. 12 DR. ALLEN: Just to say something 13 along with what Bill was talking about, there 14 are lots and lots of papers in the literature 15 on, I exposed organisms to some metal, or I

16 went out into the environment and I collected 17 organisms and I measured metallothionein in

18 them. 19 Bill, how many papers are there on

20 metallothionein? And the conclusion is 21 always, or virtually always, this is bad. And 22 what Bill was saying is exactly right. This Page 347 1 is what an organism does in response to an 2 exposure. 3 It is index of exposure, is it 4 bad? Is it bad that we get exposed or is it 5 bad that we get too much? Well, I step on the 6 scale in the morning and I find out whether my 7 exposure was too much or not. 8 Unfortunately, it generally tells 9 me that my exposure was too much, so I have to 10 do an evaluation in there to do something, and

11 it's not these values themselves. 12 On the other hand, I don't think 13 that they ought to be taken out of the 14 document. I think that they ought to be 15 there, but I think that when you prepare this 16 that it ought to be clear about what things to 17 use; how to use them; how to assess the

18 information. 19 And the other thing that I think 20 that I am correct on is that, you probably do

21 not wish to take a different office's

22 decisions on how to set criteria and somehow Page 348

1 start to set them on a different basis; that 2 probably would not be good. 3 DR. FREY: Dr. Kosnett, you wanted 4 to jump in. 5 DR. KOSNETT: I think that changes 6 in behavior have the potential to be adverse 7 effect in ecosystems because they may affect 8 predator-prey relationships and they may 9 affect reproductive activity. So they have 10 that potential. 11 They have the potential, so 12 ideally, if you wanted to be conservative from 13 the standpoint of how a pollutant could 14 perturb an ecosystem if it had an effect on, 15 for example, prey avoidance, I would consider

16 that to be adverse.

17 DR. ALLEN: And what we do with

18 the 10 to the minus 15th molar EC50 value for 19 estrogenic effects. Will we now set the lead 20 value, recommend a lead value for the world, 21 to be 10 to the minus 15th molar, which means 22 that we need to do a 99.999 percent cleanup of Page 349 1 all the environment, not what we consider to 2 be the contaminated environments; the deep-sea 3 water, the top of Mount Everest, and so on. 4 DR. KOSNETT: Well, that's 5 different than behavior, number one, and -- 6 DR. ALLEN: Estrogenic effects are 7 pretty serious.

8 DR. KOSNETT: I haven't seen that 9 study. That's a pretty provocative study that 10 you mentioned; that low. But generally 11 speaking, yes, you don't want to clean that 12 below background, so that's, you know, where 13 you go. 14 But I just think that, simply, 15 thinking that if you don't affect, you know, 16 growth, or survival, or reproduction, that

17 there can't be a behavioral effect that we 18 need to be vigilant for early on. I would be

19 concerned about that.

20 DR. STUBBLEFIELD: I don't 21 disagree with you. 22 DR. ALLEN: Right. I agree.202-234-4433 Neal R. Gross & Co., Inc. Page 350 1 DR. STUBBLEFIELD: I think you're 2 absolutely right and if the studies exist that 3 showed the relationship between a measurable, 4 quantifiable, behavioral response and an 5 effect on the organism's ability to contribute 6 to a population, i.e. survive and/or 7 reproduce, then I'm with you a 100 percent. 8 The problem is, there isn't that 9 data out there right now. The only issue that 10 I am aware of right now that's even under 11 consideration is the issue of copper olfactory 12 concerns and its potential behavioral effect 13 on salmon populations. 14 And that one, the jury is still

15 out on it.

16 DR. KOSNETT: What was that? 17 DR. STUBBLEFIELD: Copper and 18 other metals, but copper predominantly, 19 decreased reproduction in salmon with an 20 olfactory response that has been observed in 21 juvenile organisms that would suggest that 22 they may not be returning to their natal Page 351

1 streams. 2 But, like I said, that's still an 3 open question and it is not considered, now, 4 in the development of water quality criteria

5 values. So there are no metals or other 6 compounds, that I'm aware of right now, that 7 this water quality standards have ever been 8 developed or set on behavioral kinds of 9 responses. 10 But if those data exist and you 11 can show that relationship, then absolutely, 12 I agree with you. It should be incorporated 13 into it. It's just not. 14 DR. FREY: I think we could spend 15 another few minutes on Chapter 7. I would 16 like to allow some time to start talking about 17 the preface, and the executive summary, and 18 Chapters 1 and 2, before we break at 5:30.

19 It sounds to me like some of this 20 echos what I recall from comments in the prior 21 review that there were some things that were 22 treated as if they were endpoints that really Page 352 1 weren't endpoints. And I think this seems

2 like a similar discussion. 3 And they may be, sort of, like, an 4 analogy to a biomarker in a human health study 5 where they could have a consequence, but in 6 and of themselves, they don't necessarily 7 prove an adverse effect.

8 And so it sounds like that

9 distinction is still one that needs to be more 10 clearly taken into account; as I understand

11 the discussion. 12 And is it also fair to say that, 13 with regard to Chapter 7, the application of 14 the criteria, or the aspects, for judging 15 causality and for weight of evidence that are 16 given in the preamble, are those, first of 17 all, seen as equally applicable in the 18 ecological context and is there a need to 19 apply them more transparently in Chapter 7 20 than what's currently done? 21 DR. STUBBLEFIELD: I think my only 22 concern is the way that the statements are Page 353 1 made, where it says, lead exposures lead to, 2 or have a causal relationship to, something. 3 And so if we're talking in terms of a hazard 4 assessment, can lead, at any concentration,

5 cause this effect? 6 Okay. I'm good with that. I 7 mean, the way that it would be written, but to 8 infer that atmospheric concentrations of lead 9 are leading to this effect, that one is a far

10 stretch for me.

11 So I think that the text needs to 12 be tightened up to, you know, clarify that. 13 DR. FREY: Okay. So the 14 distinction is, there might be evidence for 15 the hazard but not for the dose response; for 16 example. 17 DR. STUBBLEFIELD: Exactly. 18 DR. FREY: Okay. Yes, Dr. Allen. 19 DR. ALLEN: Even more than just 20 the dose response is the question about, at 21 what concentration are we going to make the 22 decision? Before, you said that you worked202-234-4433 Neal R. Gross & Co., Inc. Page 354 1 one to two orders of magnitude above

2 environmental levels. 3 Well, these are one to two orders 4 of magnitude above what we see in many 5 contaminated waters. In fact, some of these, 6 I would venture to say, probably would only 7 exist in the effluent from a badly-operated 8 plant making lead batteries who wish to throw 9 their money down the drain. 10 And under those circumstances,

11 those concentrations don't relate to the 12 atmospheric contribution to the concentration, 13 and so it really is somewhat unclear with the

14 numbers that are in the text for effect 15 concentrations, how they relate to the 16 atmospheric component of that. 17 Where the atmospheric 18 contribution, I think, even on a pond at the 19 end of the runway from a general aviation 20 field, probably won't reach those levels. You 21 know, so some way to frame what the 22 concentrations actually are and what should be Page 355 1 considered, is something I find missing. 2 DR. FREY: Okay. Great. I would 3 like to move to the last charge question, and 4 recognize we may not get through all of it 5 today, but I think it would be good to get a

6 start on it. 7 And this is on the preface, 8 preamble, executive summary, and integrative 9 summary. We need some kind of acronym for 10 that. Maybe that group can propose an acronym

11 for that. And the lead discussants are Cliff12 Davidson and Michael Kosnett, and the co13 discussants are Dr.'s Rabinowitz, 14 Stubblefield, and Von Lindern. 15 And we have 30 minutes, so five 16 discussants, 30 minutes, it's possible, but 17 let's go ahead and start with Dr. Davidson. 18 DR. DAVIDSON: Okay. So let me 19 kind of give a very brief synopsis of how I 20 feel we have to proceed with the preamble, 21 preface, and Chapters 1 and 2. Essentially, 22 what all of this material covers is a summary Page 356 1 of what's in the rest of the chapters. 2 And so in reading through these 3 four sections, I was constantly asking myself, 4 well, where is the supporting evidence for 5 this statement? And where is the supporting

6 evidence for that statement? 7 And, of course, that supporting 8 evidence is later on. It's in the chapters. 9 Now, there are some areas of these sections 10 where I went through and did some revising 11 just because the wording is rough and so

12 forth. 13 But, you know, in terms of the 14 substance of this set of sections, what I'm 15 going to be relying on is the bullet items 16 that others are providing and going back and 17 looking at whether the sections in, say, 18 Chapters 1 and 2, which are the executive 19 summary and the integrative summary, whether 20 the statements in those chapters need to be

21 modified based on the bullet items that we're 22 getting. Page 357

1 So I guess I see these chapters as 2 being of a very different nature in terms of 3 working with them, and making suggestions for 4 change, compared to the other chapters, which 5 are, what we might call, primary chapters. 6 So I guess that's kind of my brief 7 summary of where I think we are with these and 8 I guess we're going to be relying on the 9 bullet items that others are providing in 10 order to go back and see what changes need to 11 be made in these chapters. So that's my 12 feeling on it. 13 DR. FREY: Okay. Great. And I 14 think the group that's the lead on, well, 15 preface, preamble, executive summary, and 16 integrative summary, whatever that could be 17 summarized to, has members who, for the most 18 part, are also associated with a discussant 19 group on another chapter. 20 I think Chapters 3, 4, 5, and 7, 21 are represented in your group, and possibly, 22 maybe not Chapter 4 -- no, Chapter 4 is there202-234-4433 Neal R. Gross & Co., Inc. Page 358 1 too. So 3, 4, 5 -- 6 maybe is not. So it may 2 be that, for Chapter 6 input, you really do 3 need to rely on the Chapter 6 group to 4 summarize that and get a draft, hopefully, 5 tonight. 6 But, I guess, through some 7 interaction among discussants who are assigned 8 to two groups, hopefully, can capture the 9 flavor of the key points in those other 10 chapters. Okay. Dr. Kosnett. 11 DR. KOSNETT: One thing in 12 particular that, I think, stands alone in 13 Chapters 1 and 2 is the section on public 14 health significance, is that true, Dr. 15 Vanderberg? What?

16 DR. KIRRANE: It draws on a 17 section that's in the nervous system effects, 18 pretty heavily, but there is not a section in

19 all of the health outcomes that's like that. 20 DR. KOSNETT: Okay. Because it 21 goes into other endpoints too. It talks about 22 other endpoints too and, I mean, I think it's Page 359 1 fine to focus -- my recommendation would be, 2 it would be fine to focus the public health 3 significant chapter on the things that are the 4 real driving things for which there's causal - 5 - in other words, where you establish 6 causation, then you can talk about public 7 health significance. 8 I think it's probably a little 9 more dicey to talk about the public health 10 significance of things like Alzheimer's

11 disease and references in there to autoimmune 12 disease and infection, you know, 13 susceptibility to infection.

14 I don't think we should talk about 15 the public health significance of lead 16 exposure in terms of those endpoints for which 17 causation is possible, perhaps, but not

18 established. 19 I think we're on safer ground to 20 talk about causation. Still talk about public 21 health significance, but for the endpoints

22 that we feel causation is established. Page 360

1 And the two that standout most in 2 this documents, to me, are the cognitive 3 effects of lead at low dose, for which there's 4 no threshold identified, and I think that 5 there's a causal relationship established 6 between lead, and hypertension, and 7 cardiovascular mortality.

8 We don't know where the low dose 9 is, but it's generally been only established 10 in populations that have had years to decades 11 of exposure of blood leads, probably between 12 10 to 20, or 25. 13 So I think talking about the 14 public health significance of those two 15 endpoints would make sense and then to 16 possibly back off the other discussion. 17 There was one other thing that 18 caught my eye on Page 2.54 and there was a

19 sentence in there that there's no safe level 20 of lead exposure. 21 And I think EPA, in this document, 22 it might be prudent to avoid the issue of Page 361 1 calling a level safe, because determining

2 what's a safe level or not a safe level is a 3 risk management decision. 4 You know, I think what we said at 5 CDC, right, that there's no level of lead 6 without deleterious effect, or it has been

7 shown to have -- because we don't like to tell 8 people in public health that if you have a 9 blood lead of 1 that's not safe, you know, 10 because safe or not means, like, are you going 11 to take action to protect your family or 12 something like that.

13 So that's a -- 14 DR. VANDERBERG: Are you seeing

15 that in the document? 16 DR. KOSNETT: Yes. Page 2.54. So 17 I just don't like to use that term. 18 DR. FREY: It's on Line 20; in the

19 middle of that line. 20 DR. KOSNETT: I just think it's 21 just not advisable to use that term. I know 22 what they meant. There's no level without202-234-4433 Neal R. Gross & Co., Inc. Page 362

1 deleterious effect that has been shown to be

2 without deleterious effect. 3 DR. RABINOWITZ: So just change 4 the wording. 5 DR. KOSNETT: Yes. Okay. And 6 then, you know, the rest of my comments, 7 basically, mirror the concerns that I 8 expressed on causation analysis, but those can 9 be addressed simultaneously in the revisions 10 to the Chapter 2 and Chapter 5. So that's, 11 essentially, my take. 12 DR. FREY: Right. Yes. And since 13 we've already had quite a bit discussion on 14 Chapter 2, so, yes, great. Dr. Rabinowitz. 15 DR. RABINOWITZ: Well, you have my 16 written comments, but may I first ask, is 17 there a lawyer in the house? 18 DR. FREY: Would you like there to

19 be one. 20 DR. RABINOWITZ: No. I'll play 21 lawyer then.

22 AUDIENCE MEMBER: There is one. Page 363 1 DR. RABINOWITZ: Uh, oh, well, you 2 keep me honest then, sir. As I understand it, 3 in legal terms, you can be, in some civil 4 cases, the test is if it's beyond a reasonable 5 doubt, or more likely than not, and then 6 there's beyond any reasonable doubt. 7 So the legal profession, of which, 8 I'm not a member, has some way of grading 9 certainty. And here, the EPA's adopting ways 10 to try and talk about causation with, I think, 11 levels of certainty to how much is proven and 12 not proven, but I think we're kind of 13 wrestling with that. 14 But I just want to throw out the 15 idea that maybe there's some way we could, oh, 16 I hate to say this, learn something from our 17 legal friends about how confident you have to 18 be in something before you come down and say, 19 guilty or not guilty. 20 Let me move on to another subject. 21 You got my comments. I certainly do think 22 it's a much improved draft. You've heard that Page 364 1 and I give more reasons why I think it's 2 improved. I have more suggestions, like, in 3 the table of contents, why not add the 4 preamble and preface to that; small things? 5 Some other small examples, I give 6 suggested wording. See, the trouble with 7 being a reviewer is, you kind of want to be an 8 author too. And you want to kind of, see, I 9 would write it differently. So I'll leave it 10 to you whether or not you want to take my 11 suggestions or not. 12 But I hope you look at each one 13 one at a time. Let me give you an example, 14 for instance, on Page 229, Line 5, you talk 15 about leaf uptake of lead in plants. 16 And that's 229, just one little 17 example here, Line 5, and I was just going to 18 suggest, after the word leaves, you talk about 19 the atmosphere, and you just might point out 20 to the reader that, leaves have waxy cuticle 21 layers that bind lead particles and little 22 lead actually enters the stoma of a leaf; just Page 365

1 a little detail like that. 2 And I have a few other things like 3 that. My assumption is that there will be 4 people who only read the first chapter. Maybe

5 there'll be a few more who read the first and 6 second chapter. A lot of people won't go 7 beyond that so any little tidbits you can give 8 people to help them digest these things might

9 be useful. 10 And maybe I should let you read my 11 comments on your own. I did want to mention, 12 again, if I may, the air/lead, blood/lead, 13 relationship slope which appeared later in it, 14 and I offered those two additional articles; 15 peer reviewed. 16 You take one, or both, or neither, 17 I guess, I think the one that we did at the VA

18 is useful because it was a real measurement on 19 people. It wasn't epidemiology and trends. 20 We actually measured how much lead 21 went into somebody and how much lead came out 22 of somebody, and we actually measured202-234-4433 Neal R. Gross & Co., Inc. Page 366 1 something. So you may want to use that. 2 Although I could go on, I pass for

3 now. 4 DR. FREY: Okay. Hey, we may 5 actually get through all the discussants 6 before 5:30, but that will depend on Dr.

7 Stubblefield. 8 DR. STUBBLEFIELD: Thanks, Chris. 9 Actually, I think most of my comments on these 10 two chapters have already been touched upon in 11 our discussion of Chapter 7, so the only issue 12 that I really had was, again, how one draws 13 conclusions about exposure concentrations and 14 how you get that from air deposition versus 15 surface water discharge, or something of that

16 nature. 17 It's a really difficult problem, 18 but if we don't get a handle on it, then I 19 don't see how we can ever evaluate and come up 20 with "safe" or acceptable atmospheric

21 concentrations of lead. 22 So I think that's key to the Page 367 1 entire effort and I would just draw your 2 attention to that and hope that we can get 3 that addressed more specifically in the 4 overall chapters, because I do think it's very 5 important. I'll leave it at that. 6 DR. FREY: Okay. Thank you. Dr. 7 Van Lindern. I've proven you wrong. 8 DR. VON LINDERN: You're putting 9 me between the panel and happy hour and I do

10 have -- 11 DR. FREY: No pressure.

12 DR. VON LINDERN: Lots of 13 pressure, quite a few comments. I wonder if 14 I could get the first slide that came up this 15 morning; Page 2 of the -- 16 DR. FREY: Can we get the -- this 17 is a slide from the EPA's presentation? 18 TECHNICIAN: First presentation?

19 DR. VON LINDERN: Yes. 20 DR. FREY: First presentation

21 Slide 2. 22 DR. VON LINDERN: And I guess I Page 368 1 don't see these chapters as just a summary of 2 the other chapters. I see this as where the 3 process, the procedures, the application of 4 policy, the history that's been done before,

5 is laid out. 6 And those are some of the things I 7 take issue with because I really think the 8 agency is missing a huge opportunity and, 9 frankly, they have a great legacy in lead 10 regulation in this country and the successes

11 that have come as a result of that. 12 And now, narrowing this process, I 13 don't think that's, in my opinion, where you 14 want to go. So I'm going to take a few 15 minutes to try to convince you of that. 16 If you look at this chart, we 17 start up in the corner with limiting ourselves 18 to peer-reviewed studies. So a hell of a lot 19 of the good information out there in the world 20 that should be going into policy decisions 21 isn't coming through the peer-reviewed

22 literature. Page 369

1 And historically, you haven't 2 limited yourselves to that. The previous air 3 quality criteria documents, the staff often 4 did analyses of trade literature, of 5 professional reports, and other information, 6 and used that information, and brought that

7 before the committee to be vetted. 8 And that's part of the complaint I 9 had this morning. There's now nothing on use, 10 consumption, production and disposal because 11 that doesn't show up in the peer-reviewed 12 literature. It shows up in the agency's work 13 and there's a lot of good work out there the 14 agency could take advantage of. 15 Secondly, in this document, you're 16 limiting yourself to only exposures within one 17 or two orders of magnitude in the United 18 States. So you're eliminating the rest of the

19 world from consideration. 20 But the rest of the world is going

21 to look at this document. I tried to count 22 up, in the front pages of this, how many PhDs202-234-4433 Neal R. Gross & Co., Inc. Page 370 1 are working on this thing. It's over a 120. 2 There's no other agency in the government 3 that's going to put another 120 PhDs on a lead

4 assessment. 5 CDC is cutting their work, State 6 Department doesn't do this kind of work, the 7 country looks to you for the current

8 assessment on the science about lead. And the 9 world looks at this country, so this is an 10 important document. 11 And to limit it like that, I 12 think, personally, I don't think scientists 13 should be doing that. Scientists should not 14 predetermine what's relevant. That should be 15 done later by people who are applying the 16 technology or people who are looking at the 17 policy. 18 But to, up-front, say, we're going 19 to exclude certain parts of the world from 20 these considerations is prejudicing the 21 document in my opinion. 22 Thirdly, because we haven'tPage 371

1 collected the data, and because we're not 2 reviewing all the data, we've already ceded 3 the risk assessment. It's not going to 4 happen. You're not going to do it. You're 5 going to use last time's risk assessment. 6 So the whole rest of that process 7 is already predetermined; where this is going. 8 And I don't think that's taking advantage of 9 what the agency could do or what the agency 10 has done in the past.

11 So I wanted to take the time to 12 talk about a couple of examples that perhaps 13 would show why it might be better to take a 14 broader view in an oblique disclosure, these 15 are two things I work on, currently, and I've 16 worked on for a long time. 17 And first, the Bunker Hill site in 18 Idaho. This agency has just acquired $800 19 million to spend on cleaning up that site. 20 Well, they will spend over the next 20 to 30 21 years, and that's after the health problems

22 have been resolved there. Page 372 1 We spent the last 20 years working 2 on the health problems and, frankly, I've 3 spent the last 37 years on this committee, and 4 I had the good fortune to be on this committee 5 because I was the lead scientist, at 25 years 6 old, of that situation. 7 We had lots of poisoned kids. We 8 had an average blood lead of 70 in less than 9 5-year-old kids there. And today, and for the 10 last decade, that number has been less than 2. 11 During that whole time period, we 12 worked closely with NCEA right here, on an 13 annual basis, all the time, and we like to 14 think, I know, that they helped us do a better 15 job of cleaning up that site. And I like to 16 think that us working with them helped them to 17 promote better science here.

18 We were the first site to use the

19 IEUBK model and worked with that over the 20 years with the staff here all the time. Right 21 now, now there's $800 million there to spend. 22 That money is going to be spent on ecological Page 373

1 and welfare effects. 2 We would hope that the same kind 3 of progress that was made in the health 4 earlier, could be done in the areas of Chapter 5 7 here, over the next 20 years, in which EPA

6 would work with the divisions here that work 7 with the regions to apply the best science out 8 there, monitor those situations, and learn 9 from it, and have the same kind of progress on 10 the ecological side that was observed on the 11 health side previously. 12 But there is another policy 13 consideration about that $800 million. A 14 series of a settlement with mining companies. 15 Those mining companies have made, and are 16 continuing to make, that money from overseas 17 production because we don't produce lead in 18 the United States anymore.

19 We use a lot of lead and we don't 20 recycle a hell of a lot of it, so most of it's 21 coming from overseas and a good deal of our 22 waste is going back overseas. Yet, those202-234-4433 Neal R. Gross & Co., Inc. Page 374 1 companies operating overseas are providing the 2 dollars that are doing the ecological cleanups

3 in the U.S. 4 And some of that is coming at the 5 expense of the health of children in those 6 countries. That should be policy relevant.

7 We shouldn't have a document about the science 8 of lead poisoning and exclude those children 9 from the rest of the world who are, perhaps, 10 suffering because of our policies and our 11 procedures.

12 I don't know that that's an issue 13 for the air quality division, or an issue for 14 this document, but it certainly should be an 15 issue for the Environmental Protection Agency

16 and for the United States. 17 So if it's irrelevant here, one of 18 my questions is, where is it relevant in the 19 process? 20 Now, the other side I want to talk 21 about is Nigeria. And it's not just Nigeria, 22 but there are more kids dying of lead Page 375

1 poisoning, higher levels, more severe damage 2 going on, on this planet right now than has 3 ever been before. It's just not happening in

4 the United States. 5 Just some numbers to put it in 6 perspective, 500 kids died in six months in a 7 population of 10,000. A third of the children 8 under 5 in these villages died of 9 encephalopathy. 10 We'll get these kids into 11 treatment. The average blood lead level of 12 kids coming into treatment is a 130. There

13 are children who have survived with blood 14 leads over 700. They're in terrible shape. 15 They're going to be a burden on their 16 communities for as long as they're there. 17 Soil/lead concentrations are 10 18 percent in these homes. So there are severe 19 problems, ongoing, and they're not unrelated 20 to U.S. policy. And I'll just finish quickly 21 so we can go to beer. 22 If you go all the way around that Page 376 1 chart and you go back to the criteria document 2 that we did in 1986, which was followed up by 3 an attempt to revise the standard, and there 4 was actually a recommendation to revise the 5 standard at that time, that EPA didn't take 6 up. 7 That's why they had to be sued in 8 2006 to do it again and get the standard we 9 have today. But it wasn't totally 10 irresponsible at that point, what the agency 11 did, and that was Administrator Reilly at that 12 time, convened an SAB to look at the 13 consistency of lead policy across the entire 14 agency. 15 And that was a great exercise and 16 it really helped the agency to be able to look 17 at, if they weren't putting lead in the air, 18 where was it going and where else could we

19 deal with it? 20 And a lot of the other cleanups 21 that have occurred, have occurred as a result 22 of that policy. I would hope that the agency Page 377 1 would take that kind of view again today 2 because this process looks to me like they're 3 trying to dismiss lead because it's not in the 4 air anymore in the United States. 5 But it's certainly continuing to 6 be a public health problem in this world and 7 a lot of kids are suffering as a result. And 8 there should be somewhere in the agency that 9 deals with that. So that's my question; where 10 is it? Thank you. 11 DR. FREY: Okay. Dr. Rabinowitz. 12 DR. RABINOWITZ: Ian, thank you 13 for your global insight. I just need a point 14 of clarification. In the tragic situation in 15 Nigeria, the lead poisoning, it's not a result 16 of trying to reclaim lead or the lead 17 industry, they're looking for gold, as I 18 understand it, I may be wrong, and the lead 19 just happens to be overlying a gold deposit. 20 So they incidently get poisoned to lead. 21 It's not because of, we're 22 exporting our lead batteries to Nigeria.202-234-4433 Neal R. Gross & Co., Inc. Page 378

1 DR. VON LINDERN: No. That's

2 correct. That's associated with artisanal 3 mining. 4 DR. RABINOWITZ: They're looking 5 for gold.

6 DR. VON LINDERN: All of it is 7 associated with the price of metals worldwide. 8 There are other examples that are more 9 directly related to our policy, but the point 10 is, and you're giving me a chance to give one 11 of my last points, is that this is a 12 scientific assessment about the aspects of 13 lead and it should be multidisciplinary, and 14 it should include all of those aspects.

15 There should be an interest that 16 these types of situations are going on 17 regardless of how related they are directly to 18 our policy. And, frankly, the only reference 19 to Nigeria in that 1100 pages is to 20 contaminated cocoa that's being imported to

21 the United States. 22 We shouldn't put those kinds of Page 379 1 blinders on in terms of looking at what we can 2 learn about lead worldwide. And as an aside, 3 what I'm learning over there, and I tried to 4 articulate it this morning, is, a lot of what 5 I felt was certain knowledge about lead 6 exposure and how it translates to blood lead, 7 it only applies here.

8 It's different over there. 9 DR. RABINOWITZ: Points on a slope

10 for some of these.

11 DR. VON LINDERN: Yes. All of 12 these slopes that we deal with in air, and 13 soil, and all of that, have all of the complex

14 factors that we understand now about lead 15 poisoning built into them. 16 And as you begin to pull those 17 out, we're not down there yet to where we 18 absolutely know what's going on inside of 19 people. There's a lot more to learn and I 20 think EPA should be interested in learning, 21 not just in trying to focus on whether there's 22 lead in the air in the United States right Page 380

1 now. 2 DR. FREY: Let's see, Dr. Allen? 3 DR. ALLEN: We do export a lot of 4 lead for recycling in the form of e-Wastes and 5 there are major health problems with e-Wastes 6 in many countries. The one that's documented, 7 probably the best is in China, but there are 8 lots of other ones, and I don't think that's

9 mentioned at all. 10 DR. FREY: Yes. I think, John, 11 I'll give you the mic in a minute, I think the 12 challenge here is just that there is a 13 statutory mandate that, I think, does 14 constrain the scope of the NAAQS review 15 process. 16 And on the other hand, clearly, 17 lead is a multimedia pollutant and it exists 18 in many forms, and there's many exposure 19 routes and pathways. And I guess the thing I 20 interpret from some of your comments, Dr. Van 21 Lindern, is that, in some ways, the assessment 22 is a bit misnamed because it's not, in the Page 381 1 sense that you describe, it is not a truly an 2 integrated science assessment.

3 It's a science assessment tailored 4 to a specific problem. And I think you're 5 right that, you know, this is a tremendous use 6 of resources, of, you know, PhD-level people 7 working on an assessment for lead, and it will 8 be an important reference that will be cited 9 by many, but it won't address all the issues 10 that you raise. 11 And I don't know that it can go 12 very far with those issues and maybe some 13 cursory acknowledgment. It seems like there

14 was a 1991 document that's referenced in the 15 ISA that was a U.S. EPA document on a strategy 16 for reducing lead exposures that gets more at 17 what you are describing. 18 And it looked at, more broadly, 19 across all the different regulatory program

20 offices of EPA and I don't know to what extent 21 it looked internationally, so it may well be

22 that there's a critical need for that.202-234-4433 Neal R. Gross & Co., Inc. Page 382 1 And that, unfortunately, this is 2 probably not the right forum for that. And 3 whether it's something that the SAB could do, 4 or the National Research Counsel, or whomever, 5 and to build on this ISA to add those things, 6 could be quite valuable. 7 But anyway, John, I think you 8 would like to say something. 9 DR. VANDERBERG: I actually think 10 you said that very well is that, as this 11 process is very much focused on our primary 12 purpose, is to support the National Ambient 13 Air Quality Standard setting process. This is 14 not a global science assessment, but we do 15 recognize that it is used globally. 16 People will refer to this document 17 around the world. It'll be downloaded many, 18 many times and that's what we find for our 19 assessments is that they are viewed as very 20 important documents globally, and we recognize 21 the importance and the value of that. 22 In other venues, and I'll use Page 383 1 mercury as an example, there have been the 2 recognition of this global nature of the 3 problem, and what has come of that is a larger 4 scale coordination of the planning process, 5 reports to Congress, and so forth.

6 That's not where we are here with 7 this particular assessment nor are we that for 8 our other integrated science assessments, but 9 I can certainly appreciate your comments and 10 recognize the importance, and the tragedy that 11 occurs in places like Nigeria, and China, and 12 others, but that is not the purpose and the

13 focus of this document. 14 And I'm sorry that that's the 15 focus and the disappointment that that may 16 bring, but it is important for us to focus on 17 supporting this process because this alone is 18 extremely important for us as a country, and 19 that is our primary focus. 20 And as we develop a plan for this, 21 as you see, the integrated review plan, we do 22 layout that scope, you know, in consultation Page 384 1 with CASAC, as well as with collaborations

2 with Office of Air and Radiation as well as

3 our Office of General Counsel. 4 So I think from the get-go, we 5 layout what the scope is, and again, 6 recognizing it's not necessarily going to meet 7 all the needs that may be out there for this 8 type of information, but it's the way in which 9 we are working at this point. 10 DR. FREY: I wonder, not that this 11 would address the issues you raised but, if 12 it's worth, even if it's a page or something, 13 that just more clearly acknowledges that there 14 are some things beyond the scope of this

15 assessment. 16 And to the extent there are any 17 really key documents that might touch on some 18 of those other issues, just, you know, to give 19 someone a little bit of help if hey stumbled 20 across this, and they read it, and realize, 21 oh, this is only focused on air. Is there 22 someplace else I can go? Page 385

1 And maybe a few references, but I 2 don't think that could be a major focus of 3 this document, but maybe that would help, at 4 least, clarify that this document is not 5 trying to be, you know, everything to 6 everyone. 7 DR. VON LINDERN: So I can give a 8 little summary, first, I'm not a virgin and I 9 understand your position completely. And I 10 know you're doing the job that you're mandated

11 to do. 12 So I was trying to goad the agency 13 a little bit, but it was also a compliment 14 because what the agency has done, and what's 15 been done from this group, and from this group 16 within EPA, over the last three or four 17 decades, has made a tremendous difference in 18 this country; obviously. You've written that 19 up. 20 It's made a great deal of 21 difference in developed countries that have 22 relied on this, and have implemented programs,202-234-4433 Neal R. Gross & Co., Inc. Page 386

1 and have benefitted millions of children. 2 Right now, there's a problem out 3 there in the undeveloped countries and the 4 more attention that EPA pays to that, 5 regardless of whether it's from here, or from 6 its international programs, or it's in 7 coordination with the State Department, or 8 whatever, the better it's going to be for

9 those kids.

10 And that's what it would be more 11 comforting to hear that that is ongoing 12 somewhere within our government. Thanks.

13 DR. FREY: Yes. I don't know if 14 we're the right group to answer that question. 15 It was a good question. Dr. Allen?

16 DR. ALLEN: I don't know that 17 these are just overseas problems. What we've 18 seen in the past couple of years is a 19 tremendous increase in metal prices. We have 20 had, in Philadelphia, the copper lines for the 21 trolleys cut down. A couple of people

22 electrocuted. Page 387

1 And those are being stripped and 2 the insulation burned off with home-type of 3 things; open fires and so on. If the same 4 thing is going on with e-Wastes, and so on, 5 within the United States, you have a 6 population exposed to high lead concentrations 7 along with high everything elses.

8 And I don't know whether that 9 exists or not. Is there any information?

10 DR. ROSS: It's not in the

11 National --

12 DR. VANDERBERG: It's not in the 13 National Emissions Inventory is what Mary was 14 saying. 15 DR. ALLEN: Well, that I know.

16 DR. VANDERBERG: We don't have a 17 line on that really. 18 DR. ALLEN: Has CDC, you know, 19 seen anything like that; I wonder? Do you 20 know? You know, I just wonder if this might 21 not be an emerging problem that then does

22 deserve some attention. Page 388

1 DR. FREY: I would like to hit the 2 pause button on our discussion, since it's a 3 little bit after 5:30, and we'll have an 4 opportunity to discuss more. I don't know, 5 John, will you be here tomorrow?

6 DR. VANDERBERG: Yes. I would 7 like to say, actually, for a longstanding 8 family vacation, I won't be here tomorrow. 9 DR. FREY: Oh, okay.

10 DR. VANDERBERG: But I wanted to 11 extend our appreciation for your time today 12 and tomorrow. Your pre-meeting comments, very 13 valuable to us. Your post-meeting report and 14 comments will be extremely helpful to us, so 15 thank you very much for your time. 16 And again, I apologize for 17 arrangements that had been made before this 18 meeting was scheduled, so I'm sorry I won't be

19 here. 20 DR. FREY: Oh, that's okay. 21 DR. VANDERBERG: But Mary and crew

22 will be. Page 389

1 DR. FREY: Well, I'm glad you 2 thanked us before what I'm about to say. 3 DR. VANDERBERG: And we're done, 4 right? 5 DR. FREY: Okay. So I think in 6 terms of process, I think it's fairly clear. 7 All the groups that have reported, which 8 includes all the groups, should try to collate 9 a first draft of the consensus response to the 10 charge questions. 11 Phil Goodrum, I think, wins the 12 award for sending a draft already, so the rest 13 of you are way behind. And you can thank Phil 14 for making you all look bad. 15 And if you can get the draft, and 16 I would encourage you to copy me on it, and 17 copy Ed Hanlon, and also copy Aaron Yeow, and 18 remember, don't send a draft to the entire

19 committee. 20 You can caucus among a small 21 number by email, but, you know, it should be, 22 I guess, nominally, less than half of the202-234-4433 Neal R. Gross & Co., Inc. Page 390 1 total panel. So you can certainly do that 2 within your groups. 3 If you can get something by 9:30, 4 10:00-ish, you know, there's a good chance 5 I'll see it. Definitely, please get it by 6 about midnight or so, and Ed promised that if 7 we have them by midnight that we would be able 8 to have hard copies, one way or another, by 9 tomorrow morning when we reconvene. 10 And, of course, the more you get 11 done here, the less you have to do later, and 12 we're all busy in our home institutions. Yes. 13 DR. WASSERMAN: Did you want us to 14 coordinate with the person who was writing the

15 consensus statement? 16 DR. FREY: Right. So the lead 17 discussants have the mandate, and charge, and 18 responsibility, to put together the consensus 19 response with the input of members of your 20 group, and also, of course, there have been 21 some panelists who've commented on charge 22 questions that they were not assigned to, and Page 391 1 you should take that account as well. Phil.

2 DR. GOODRUM: Those individual

3 comments will still be -- 4 COURT REPORTER: Could you use the 5 microphone. 6 DR. FREY: Individual comments, 7 you're welcome to revise if you're ready to 8 resubmit. Do that as soon as you can. We 9 would like to get those within two weeks and 10 we do want to get the final charge question 11 responses within three weeks, but let's try to 12 get as much done by tomorrow as we can. That 13 will help us. 14 And also, if we can get a hard 15 copy, we can take a little bit of time 16 tomorrow to go over and see where we are and 17 whether there are any rough edges, or, you 18 know, hopefully we're close to a consensus on 19 answering all of the charge questions. 20 I think something we need to 21 consider, and this is why I thanked John for 22 thanking us before I made these comments, but Page 392 1 I've already mentioned this to John, so he 2 knows this, that, based on the Chapter 5 group 3 comments, and I guess the question is whether 4 other groups have similar concerns, is whether

5 there's a need to see a third draft of the ISA 6 before we, as a panel, are comfortable with

7 it. 8 My hypothesis right now is that, 9 with at least some aspects of Chapter 5, there

10 seems to be a need for further refinement and 11 that it's substantial enough that the panel 12 would probably like to see that.

13 I don't think we need to vote on 14 that right now, or make a decision tonight, 15 but, obviously, we do need to advise EPA by 16 tomorrow on that. So I think it's something

17 we can consider. 18 And I've talked to the group 5 19 panel, or subgroup, and they will think about, 20 if we were to ask for a third draft, what 21 might be the priorities be in terms of what we

22 would like EPA to do. Page 393

1 And so for the other groups, I 2 think for some of the groups, the comments 3 were mostly positive with some criticisms, and 4 probably many of the criticisms we could trust 5 that EPA would do, take into account, and not 6 necessarily need to see a third draft. 7 But I think in Chapter 5, 8 especially, that it may be more than that. So 9 I just mention this now because I think we'll

10 need to talk about it a little bit tomorrow 11 during the morning session. 12 And, of course, in the morning 13 session, we'll also have a presentation from 14 EPA on the planning for the policy assessment, 15 and if you recall, the risk and exposure 16 assessment is going to be combined into the 17 policy assessment. 18 So we're not going to have an REA 19 to review, so tomorrow morning is kind of in 20 lieu of an REA, but it's really a preview. 21 It's not a final product for us to review.

22 We will have a review of the202-234-4433 Neal R. Gross & Co., Inc. Page 394 1 policy assessment, I think, in the early fall

2 is when that's scheduled as of now. Let me ask 3 the DFO, or Vanessa, have I left anything out?

4 MR. HANLON: I don't think so.

5 DR. FREY: And I know there were 6 some hands that went up, are there any 7 questions from the panel, or, John, do you 8 want to take back your thank you? All right. 9 DR. JOHNSON: Can we leave papers

10 in this room?

11 DR. VU: Yes. You can leave the 12 paper, but please bring your laptop with you. 13 DR. FREY: Okay. So before I 14 adjourn for the evening, thank you so much. 15 I think everybody has contributed very 16 productively to today's meeting. I wish you 17 a productive evening in writing the consensus 18 response to the charge questions. We will 19 reconvene at 8:30 a.m. sharp. See you tomorrow 20 morning. We are adjourned. 21 (Whereupon, the above-entitled 22 matter went off the record at 5:45 p.m.)

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involve44:8 189:10 involved41:4,18

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