Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

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U.S. ENVIRONMENTAL PROTECTION AGENCY

CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE (CASAC) LEAD REVIEW PANEL

PUBLIC MEETING

HILTON GARDEN INN RALEIGH-CARY CARY, NORTH CAROLINA 27518

FEBRUARY 5, 2013

Court Reporter: Wanda L. Greenlee, CCR Missouri CCR #1188 Midwest Litigation Services 711 North Eleventh Street St. Louis, Missouri 63101 (314) 644-2191Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 2 1 (WHEREIN, meeting convenes at 8:32 a.m.) 2 MR. YEOW: So good morning. I'm Aaron 3 Yeow. I'm the designated federal officer of the DFO for 4 this public meeting of the Clean Air Scientific Advisory 5 Committee Lead Review Panel. I'd like to convene and open 6 this public meeting with a short statement. 7 The panel's meeting today and tomorrow is 8 to conduct a peer review of EPA's draft of integrated 9 science assessment for lead and draft policy assessment 10 for lead. I'd personally like to acknowledge and 11 congratulate Dr. Christopher Frey for being selected as

12 the new chair of the charter CASAC. 13 CASAC is a federal advisory committee. And 14 by EPA policy, its meetings and deliberations are held as 15 public meetings that meet the requirements of the federal 16 advisory committee act, also known as FACA. Through the 17 charter CASAC, the panel's empowered by law to provide

18 advice to the administrator. 19 Consistent with the requirements of FACA 20 and with EPA policies, the deliberations of the panel are 21 conducted in public -- at meetings for which advanced 22 public notice is given. The discussions and substantive 23 deliberations of the panel, its interactions with the 24 public and the agency are conducted in sessions where I, 25 as the DFO, am present to ensure that the requirements ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 3 1 FACA are met. 2 This includes requirements for open 3 meetings for maintaining records of deliberations of the 4 panel, making available to the public summaries of 5 meetings and providing opportunities to the public

6 council. 7 We did not receive any written public 8 comments, and we do not have any registered public 9 speakers. However, there will be an opportunity for the 10 public to provide clarifying remarks toward the end of the 11 discussion of the ISA and, of course, at the end of the

12 discussion of the PA. 13 So for that -- I think on our agenda we -- 14 and Chris can cover this while we're on the agenda. But 15 at the end of the discussion of ISA today, so that will be 16 at noon, there will be an opportunity for the public to 17 provide clarifying remarks on the ISA. 18 So just notify me by e-mail or come up to 19 me, I would say probably by 11:30, to let me know if you 20 would like an opportunity for that. Minutes of this 21 meeting are being taken to summarize discussions and 22 action items in accordance with the requirements under 23 FACA. These minutes will be certified by the chair once 24 completed. 25 I want to remind all in attendance today ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 4 1 the status of this panel's compliance with federal ethics

2 laws. The SAB staff office has determined that there are 3 no issues of conflict of interest or an appearance of a 4 lack of impartiality for any of the advisory panel members 5 participating in this review. 6 And as many of you know, Dr. Vanessa Vu, 7 our previous SAB staff office director, has retired. And 8 Dr. Christopher Zarba here is our acting director now, and 9 we also have Mr. Thomas Brennan as our deputy director. 10 So I'd now like to turn the meeting over to 11 Mr. Thomas Brennan, deputy director of the SAB staff 12 office, then over to Dr. Christopher Zarba, acting 13 director of the SAB staff office, and then over to 14 Dr. Christopher Frey, chair of the CASAC. 15 MR. BRENNAN: All right. Thanks, Aaron. 16 I'm Tom Brennan. I'm the deputy director of the SAB's 17 advisory board. I'd like to thank the panelist for taking 18 time out of their personal and professional lives to 19 provide this public service. We very much appreciate your 20 efforts. Getting science advice from the CASAC is really 21 important to the agency and ultimately to the American 22 public. So, again, thank you very much for your efforts 23 and for your energy.

24 And I'd like to thank the EPA team that 25 made this possible. All the hard work it takes to get toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 5 1 a moment like this, and I know how hard they've all 2 worked, and that also is appreciated. 3 Like Aaron said, this is our first meeting 4 without Vanessa. And, you know, Vanessa had a 30-plus 5 federal career, 30-plus years and the last ten as our 6 director. And Aaron and I and a couple of other people 7 said -- you know, had the moment this morning like, What 8 would Vanessa do? And we kind of smiled. And we said, 9 You know, we just can't do it the way she did it. So we 10 just had to let it go.

11 But her attention to detail and her 12 commitment to these FACA committees, this one, the SAB and 13 the council was really remarkable. And she definitely 14 left a legacy and an imprint on all of those that worked 15 for her. So we're definitely going to miss her, and we're 16 thinking about her today. And happy for her retirement. 17 But, also, very excited to introduce our -- 18 like Aaron said, our new director, Christopher Zarba. And 19 I know he'd like to say a few words, so I'll just turn it

20 over to Chris. 21 MR. ZARBA: Thanks, Tom and Aaron. First 22 of all, it's Mr. Christopher Zarba. 23 MR. BRENNAN: Oh, I'm sorry. 24 MR. ZARBA: I earned it the hard way. I 25 asked Aaron for a few minutes just to introduce myself toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 6 1 you. I think today is Day 8 in my position as acting 2 director of the SAB. I thought it would be worth just 3 spending a few minutes to give you a little bit about who 4 I am, why I'm here and what I hope to accomplish. 5 I've been with the agency for over 30 years 6 too, and I've worked in a variety of programs within the 7 office of water, within the Superfund, in and out of the

8 water and ORD a few times. I was chief of staff to the

9 research office for 3 AA's. 10 And over the last seven or eight years, 11 I've been both acting director and director of the

12 National Center for Environmental Research. That's the 13 extra grants portion of the research program. And 14 hopefully some people here have received star grants. 15 So it's a job that I really enjoy. About 16 the only thing that I've been consistent through my career 17 is that I've worked very closely with the SAB throughout 18 my entire career. And very early in my career I had the 19 pleasure of working with Dr. Herb Allen here. We were 20 both on the other side of the fence in developing new 21 types of criteria for the office of water. It was a very 22 unique time that we had a very interesting mix of 23 academics, ORD scientists, program office and contractors.

24 We took on what I consider some of the 25 toughest remaining environmental issues left, and it wasMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 7 1 an amazing process. I wish I was, at that time, bright 2 enough to see the value of the SAB; I wasn't. But I had 3 very good advisors and coaches, and I lived the experience 4 of taking on very difficult issues. We had the -- a 5 variety of people who were against what we were doing. 6 We worked very hard. We used the SAB in 7 all the best sense. We knew we were going to be in front 8 of the SAB. We planned our research knowing that we would 9 have to pass that test before we even got to the SAB. We

10 had consultations. We listened to the advice. We 11 followed the advice we got from the SAB. And I had the 12 pleasure of using the SAB findings when the inside EPA 13 would call every month and say, you know, according to so 14 and so, so and so, they said this. 15 And I would always have my SAB report and 16 could take quotes right out of it, saying, Well, according 17 to the Science Advisory Board -- and this is the truth. 18 And I was amazed at how powerful having that document in 19 my hand was and how effective it was in helping the agency 20 make real changes. So according to Vanessa, I drank the 21 Kool-Aid early on in life, and I've always been an

22 advocate for that. 23 And most recently, in the interim, we 24 worked with the SAB on the state awards, and I've been an 25 advocate for getting the environmental justice technicalMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 8 1 guidance in front of the SAB. So it's a thrill to be 2 here. When I was in the interviews they asked me, you 3 know, why I wanted the job and was I not happy where I was 4 at. I said, No. I actually loved the job I was at. I 5 had a great boss and a great staff. And I really would be 6 thrilled if they didn't give me the job, I could get to go 7 back to that job I really loved. 8 Well, then they said, Well, why do you want 9 this job? And I said, Because I know of no place where a 10 handful of people can have more of an impact on the 11 effectiveness and the credibility of the agency than the 12 SAB. And I absolutely believe that.

13 So I'm here for selfish reasons. I want to 14 be part of that. I know what it feels like to make a 15 difference. So I'm here because I really believe in the 16 SAB, and I want to do what I can to keep that -- what 17 Vanessa has kept going, to keep it going and even bring

18 some new ideas to the table. 19 I think the challenges for the agency are 20 going to be tougher in the future. Money is getting 21 short. The scrutiny is going to get tougher, and I think 22 we always have to be looking at how we can do things

23 better. 24 So I know I've only been here for eight 25 days, but I want to give you a few ideas of the kind ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 9 1 things I'm thinking about and would like to have dialogue 2 with the staff, with other parts of the agency and with 3 you-all about what we can do in the future to make the SAB 4 as effective as possible. 5 And one of those areas is on the perception 6 or the reality of the balance in the panels. So Part 1 of 7 that would be there are things we do -- and much of this 8 I've just learned in the last week -- in the SAB, staff, 9 to ensure we have a balanced panel.

10 Much of what we do is not shared. So the 11 public will not know the steps that we have taken, whether 12 they were successful or unsuccessful in sharing a balanced 13 panel. And I think there's value in the public knowing, 14 whether we were successful or not, the things that the 15 science advisory board tried to do to make sure that panel

16 was balanced. 17 Secondly, I think we need to do more 18 outreach to ensure that when we do have open season in 19 getting the panel members that it's not good enough just 20 to see who applies. That I personally and others on the 21 staff will be going out to different groups through our 22 conversations about how they can serve and why it's 23 important and encouraging people to do so. 24 Another area that I think is right for 25 improvement, and I think this is maybe where I would beMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 10 1 most effective, is in encouraging all parts of the agency 2 to identify areas early on where an SAB involvement would

3 be most beneficial. 4 Right now, in many cases, it's a volunteer. 5 If you think you need a review, you can go to the SAB. 6 And all too often, those areas, those efforts that the 7 agency's taking on that are in the most need of review are 8 the least likely to step up to the plate. 9 And some of you know that ORD has gone 10 through a massive reorganization. We now are structured 11 quite different. We have a national program directors. 12 These are Title 42 super-grade positions, and they play a 13 very different role at integrating science across the 14 Office of Research & Development across the agency. 15 And I think those Title 42 national program 16 directors and others across the agency can help us do a 17 better job of identifying early on those areas where we 18 need an SAB review to actually send away teams to those 19 organizations to have consultations with them and get them 20 into the process sooner so the risks of having problems 21 down the road are less. And also to get to their 22 management that if they are reluctant, that we can make 23 the case early on why they need to be thinking about this

24 and the risks are limited. 25 So those are just some of the things I'mMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 11 1 thinking about. Obviously, I've got more homework to do 2 on that. We'll be talking to a lot of people. But I 3 think a collection of those things -- and there's probably 4 others that we can pursue that -- to help keep the SAB as 5 effective and based as possible. 6 So that's a quick summary. I guess I've 7 got a couple of minutes, Aaron, for a few questions or 8 comments. Is that okay? 9 MR. YEOW: (Nodded head.) 10 MR. ZARBA: Does anybody have any 11 questions? 12 (No response.) 13 MR. ZARBA: Well, it's a pleasure to be 14 here. It's nice to see familiar faces, and there's some 15 new faces that I hope to get acquainted with. Sir.

16 DR. VON LINDERN: I have a comment.

17 MR. ZARBA: Sure. 18 DR. VON LINDERN: First, we all certainly 19 miss Vanessa, and she did a great job. And so -- but I'm 20 heartened by your comments. And I'll have some comments 21 within my comments that reflect why. And that's because 22 having been here for almost 40 years on these committees, 23 I think the process has lost something during those years 24 that you discussed, and I'm happy to see that someone is 25 going to bring those back because this is a wonderfulMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 12 1 process that serves far beyond these documents. And the 2 criteria documents that were produced were seminal for 3 globally and every country for effecting a good elect 4 policy. 5 And I'd especially like to comment on the 6 balance of the panel because I miss the industry. We 7 don't have the other side here like we used to, and we 8 don't have the -- you know, the code and the frank civil 9 discussions around the facts that this, this forum brought

10 out. 11 And I'm heartened by your comments that the 12 agency can go back to that kind of process where the board 13 really serves as a place to work out the issues that the 14 country faces so that EPA can respond in more ways than 15 just a single document. So thanks. 16 MR. ZARBA: All right. 17 DR. FREY: Good morning. This is a 18 seasoned panel, and I guess I want to echo some of the 19 things we've heard earlier in terms of welcoming 20 everybody. Welcome, of course, to the panel members who 21 have devoted a lot of time. And you're all very busy 22 people, but this is obviously an important public service. 23 So it is a quite valuable service to the nation that we're 24 engaged in. 25 I do want to echo that, you know, in theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 13 1 retirement of Vanessa, I think she's been a tremendous 2 mentor to me. And I certainly conveyed to her directly my 3 high regard for her and best wishes for her retirement. 4 And I think that's likely to be a shared view among many

5 of us. 6 But I am happy to welcome Mr. Brennan and 7 Mr. Zarba here today. It's wonderful that they're here to

8 share their time with us. And I think some of the 9 comments Mr. Zarba made and that Dr. von Lindern picked up 10 on are, in fact, quite encouraging. And there are a few

11 remarks I have that I think will touch on some of these

12 issues as well. 13 What I would like to do is, we 14 traditionally have a brief round of introductions, just to 15 go around the table for the panel members to just say

16 their name and affiliation so we know who's here. And I

17 would like to do that.

18 And then I'll talk a little bit about the 19 -- I actually want to take a minute to talk about the 20 charter of CASAC because this brings up some issues that 21 follow onto what Mr. Zarba had to say and that also will 22 help frame our discussion over these next day and a half. 23 And then we'll talk about the agenda specifically. 24 So let me go ahead and go around the table, 25 starting with Dr. Johnson, if you -- and if each of youMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 14 1 would just say your name and affiliation. 2 DR. JOHNSON: Chris Johnson, Department of 3 Civil and Environmental Engineering at Syracuse 4 University.

5 MR. POIROT: I'm Rich Poirot. I'm with the 6 Air Program and the State of Vermont Agency of Natural

7 Resources. 8 DR. CANFIELD: I'm Rick Canfield, Cornell 9 University, Division of Nutritional Sciences. 10 DR. KORRICK: I'm Susan Korrick, Department 11 of School Public Health and Department of Environmental

12 Health. 13 DR. KOSNETT: Michael Kosnett, the Division 14 of Clinical Pharmacology and Toxicology at the University 15 of Colorado School of Medicine, also a member of the 16 Department of Environmental and Occupation Health at the

17 Colorado School of Public Health.

18 DR. FREY: This reminds me. One of the 19 real purposes of this is to get you practicing using the 20 microphones. So make sure you use the microphone. 21 DR. VON LINDERN: He brings that up right

22 in front of me. I'm Ian von Lindern. I'm an 23 environmental engineer with TerraGraphics Environmental 24 Engineering from Moscow, Idaho. 25 DR. POUNDS: I'm Joel Pounds, AssistantMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 15 1 Toxicology Department at the Pacific Northwest National 2 Laboratory. 3 DR. LANNO: Roman Lanno, Ohio State 4 University, Department of Evolution, Ecology and 5 Organismal Biology. 6 MR. ALLEN: George Allen from NESCAUM in

7 Boston. 8 DR. CORY-SLECHTA: I'm Deborah Cory-Slechta 9 from the University of Rochester Medical School. 10 DR. HAYS: Sean Hays from Summit Toxicology 11 located in Allenspark, Colorado.

12 DR. ALLEN: I'm Bert Allen from the 13 Department of Civil and Environmental Engineering and the 14 University of Delaware.

15 DR. RABINOWITZ: I'm Michael Rabinowitz. 16 I'm retired as a geochemist, but MBL lets me still use the

17 e-mail address. 18 DR. WASSERMAN: Gail Wasserman, Child 19 Psychology, Columbia University. 20 DR. HOPKE: Phil Hopke, Institute for 21 Sustainable Environment, Department of Chemical and 22 Biomolecular Engineering at Clarkson University.

23 DR. WEITZMAN: Michael Weitzman from the 24 Departments of Pediatrics Environmental Medicine and 25 Psychiatry, NYU School of Medicine.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 16 1 DR. DAVIDSON: Cliff Davidson from the 2 Department of Civil and Environmental Engineering at 3 Syracuse University. 4 DR. FREY: Okay. And I'm Chris Frey from 5 the Department of Civil Construction and Environmental 6 Engineering at North Carolina State. So thanks again to 7 all the members of the panel. We have a tremendous depth 8 and breadth of multidisciplinary expertise on this panel, 9 and so I -- it's always a privilege to serve with such an 10 esteem group of people.

11 I wanted to take a minute to talk about the 12 charter of CASAC, just to review it briefly. CASAC is a 13 scientific technical advisory committee, and it's 14 chartered under the Clean Air Act, Section 109-D. So our

15 mandate kind of stems from a statute or -- of federal law. 16 And under the CASAC charter, which is 17 submitted to congress periodically, our charter is that we 18 will review the criteria published under Section 108 of 19 the Clean Air Act and the national primary and secondary 20 ambient air quality standards and recommend to the 21 administrator any new National Ambient Air Quality 22 Standards and revisions of existing criteria and standards 23 as may be appropriate. And I think, in some ways, this 24 has been our main focus as a panel.

25 We also advise the administrator in areasMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 17 1 where additional knowledge is required to appraise the 2 adequacy and basis of existing new or revised standards. 3 We will describe the research efforts necessary to provide 4 the required information. We will advise the

5 administrator on the relative contribution to air 6 pollution concentrations of natural as well as 7 anthropogenic activity. 8 And we will advise the administrator of any 9 adverse public health, welfare, social, economic or energy 10 effects which may result from various strategies for

11 attainment and maintenance of standards.

12 And the reason I mention this is that I 13 think we tend to focus on some of these more than others,

14 and there is some broader discussion that I don't think 15 will be fully resolved at this meeting about how CASAC 16 should, I guess, operationalize to maybe more fully

17 address its full charter. 18 So I think we tend to focus quite a bit on 19 the review of existing standards and revisions among the 20 existing standards. But we do have the charter to 21 recommend any new national standards, if we choose to do 22 so. We certainly can advise the administrator on areas 23 where new knowledge is needed. And that includes advising 24 on research, if that's, you know, relevant to a particular 25 panel or, you know, review topic.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 18 1 And I think in this context of lead, of 2 course, we talk quite a bit about the relative

3 contribution to air concentrations of natural and 4 anthropogenic and even legacy issues and multimedia 5 issues. So I think we address that nicely. 6 In the context of this panel, with the last 7 part of our charter, which is advising -- essentially 8 regarding implementation of a standard, we've had quite a

9 bit of discussion about the measurement methods for 10 monitoring of lead. 11 And one might argue that's an 12 implementation issue, but we also do have the charter to

13 advise of adverse effects which could result from 14 strategies for attainment and maintenance of a standard. 15 I will note that typically, you know, 16 panels like this require a foundation of something to 17 review that usually originates from the agency. And I 18 think this is an ongoing discussion about what would we 19 like to do going forward to more fully address our 20 charter, especially regarding implementation. 21 And I should mention this is a public 22 comment that came up in the context of the ozone review 23 panel, and so it is something that we've had some

24 administrative discussion on within CASAC. And I'm 25 anticipating, and maybe this is something we can confirmMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 19 1 that -- at the July meeting of the ozone panel, which will 2 include all seven members of the statutory CASAC that we 3 will have an opportunity for some discussion with EPA on

4 some of these issues. 5 I want to point out that the strategy that 6 we use -- or the procedures we use here in terms of an 7 ISA, an REA, a PA, integrated science assessment, risk and 8 exposure assessment, policy assessment, are not 9 specifically mandated under the Clean Air Act or under 10 their charter, but these are operationally ways that we 11 receive information from the EPA and we provide feedback. 12 And I mention that, in part, because 13 there's no specific obligation on the part of the panel to 14 formally approve any of these documents, and it's also not 15 necessarily that our sole charter is to review such

16 documents. Our charter is broader than that. 17 So there may be some issues that come up in 18 the conversation here that go beyond the documents. And 19 as long as they're within our charter, I would tend to 20 support those discussions. So I just wanted to orient you

21 a little bit. 22 And this is kind of a complex issue of our 23 scope. And as the incoming chair of CASAC, this is 24 something that I wanted to kind of review both with the 25 charter CASAC, which I've done, and also with the panels.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 20 1 And as another comment, as I'm sure has 2 been explained when each of you agreed to serve on the 3 panel, there's a slight distinction between the panel and 4 the statutory CASAC. Just like in SAB there's a 5 distinction between panels and the formal SAB. 6 So in a sense, this panel is advisory to 7 CASAC and includes two CASAC members on the panel. But I 8 will tell you that seven-member CASAC relies very heavily 9 on these panels to provide the science advice. 10 So going forward, looking beyond this day 11 and the next day, we will have a process of developing the 12 written response to charge questions to the ISA and the 13 policy assessment and a draft letter to the administrator 14 on each of those that will eventually undergo what's 15 called a quality review by the chartered CASAC. 16 Okay. So then this segways into the 17 agenda. And I'll go through that, and then I'll pause and 18 see if there are any questions before we get into the next 19 part of the agenda. 20 But the agenda, we have a pretty aggressive 21 agenda. This morning, before lunch, we plan to finish our

22 review and discussion of the third external review draft 23 of the integrated science assessment. So in our 24 discussions, as I think we're well-aware, we have a lead 25 discussant on each charge question and several additionalMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 21 1 discussants. 2 And for purposes of preparing the response 3 to charge questions and the letter, it's critically 4 important that any points that we would put in those 5 written documents have been discussed in public. 6 And that's just a Federal Advisory 7 Committee Act requirement. So we cannot make any written

8 recommendations to the administrator that was not 9 presented in public and embedded in a discussion with this 10 group. 11 So anything that you think is important 12 that should rise to the level of a sentence or a paragraph 13 in the response to the charge question that goes to the 14 administrator, please bring it up. 15 On the other hand, if you have things that 16 are, you know, typos or minor editorial revisions, please 17 do not bring those up because we need to manage our time 18 efficiently. 19 I think we've all been through this 20 process. I think we're all pretty well calibrated on 21 what's important and what needs to be discussed. So I

22 don't think I need to belabor that. 23 But we do have a pretty aggressive agenda 24 for about 20 minutes per charge question on the ISA after 25 the EPA's presentation. So just be mindful of that as youMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 22 1 make your comments. And it's important that we have 2 enough time to discuss the policy assessment, which we 3 will hear a presentation on after lunch. And then we will 4 begin to discuss the responses to charge questions on

5 that. 6 I think -- I'm sure I'm not misrepresenting 7 the EPA's hopes and expectations that if all goes well, 8 the EPA would hope that this is the last external review 9 draft of the ISA. And -- but it's important to point out 10 that EPA is proposing that this first external review 11 draft of the policy assessment is the only version that we 12 would be reviewing and that the next version, they 13 propose, would be the final version. And so EPA is 14 proposing, in fact, that this would be our last 15 face-to-face meeting as the lead review panel for this 16 review cycle. 17 So it's especially important that we give 18 EPA the full benefit of our advice on the policy 19 assessment, and we can reserve judgment on whether we feel 20 we've reached closure on that as we get to the end of that

21 discussion. 22 But just please be mindful that -- you 23 know, if things go as some hope, then this would be our 24 last opportunity to provide detailed feedback. And I will 25 say, in terms of advising the administrator on the leadMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 23 1 standard, this is our kind of big opportunity to advise 2 the administrator on the indicator, level of form and 3 averaging time of the lead standard, both for the primary 4 and secondary standards. And so in some sense, that's the 5 bottom line culmination of everything we've been doing 6 over the last couple of years. 7 Okay. Let me pause and just ask, Are there 8 any questions? Yes, Dr. Allen. 9 DR. ALLEN: Can I change the tone for one

10 second?

11 DR. FREY: Sure. 12 DR. ALLEN: First of all, I promised our 13 chair that if I decide this meeting should be terminated 14 early, I will do it by making a motion. 15 Secondly, I do want to thank some of the 16 committee members specifically for the help that they 17 rendered at the last meeting. It's sometimes useful to be 18 on a panel that has a number of physicians on it in 19 attendance. And that was quite helpful, and I do thank 20 everybody for that, for their help. 21 DR. FREY: Yes. Thank you. Well, we're 22 delighted you're here too. Any other comments or 23 questions before we move on? 24 (No response.) 25 DR. FREY: Okay. All right. Excellent.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 24 1 With that, we are now at the point in the agenda where EPA 2 will deliver a presentation on revisions to the draft by 3 an integrated science assessment, and that's followed by a 4 public comment. I am -- we don't have any public 5 commenters listed, so I think we're still okay on time. 6 We would like to start the charge question discussion at

7 9:30. 8 There is an opportunity for public comment, 9 by the way, at the end of each of our major agenda items. 10 So at the end of the morning we do have an opportunity for 11 clarifying comments from the public regarding the ISA. 12 And then we have opportunities for public comments 13 tomorrow afternoon after our discussions to the policy

14 assessment. 15 So if anyone is interested in making public 16 comment, please contact Dr. Aaron Yeow to get on the -- 17 there's a list. I'm sorry, Mr. Yeow. We're promoting 18 many people, I guess, or giving out degrees today. So 19 Mr. Aaron Yeow. Okay. With -- and I'm going to turn the 20 mic over briefly to Dr. -- or Mr. Yeow and then to 21 Dr. Vandenberg. 22 MR. YEOW: I forgot to mention, Dr. Philip 23 Goodrum will be joining us by the phone sporadically, so 24 just to let you know that. And Dr. Stubblefield was not 25 able to participate. Okay, John.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 25 1 DR. VANDENBERG: Thank you very much. My 2 name is John Vandenberg, and I'm the director of the 3 Research Triangle Park Division of the National Center for

4 Environmental Assessment. And I also would like to extend 5 our appreciation to the panel for an incredible amount of 6 work. This is a significant effort from very busy people, 7 and your expertise and your pre-meeting comments have 8 been, as always, very helpful to us. We appreciate that. 9 As expected, this is, perhaps, our last 10 meeting with you in terms of discussing the integrated 11 science assessment, which I have my fingers and toes 12 crossed here. And we very much want to use this 13 opportunity to say how much we appreciate your time and 14 expertise. 15 I'd also like to extend my welcome to Chris 16 Zarba for joining the SAB staff. It's tough shoes to

17 follow for Vanessa. I think the entire time I've worked 18 with CASAC has been with Vanessa, and so it's -- we 19 welcome you. Of course, Chris, I've known you for many, 20 many years. So I appreciate that. I'm glad that Tom's 21 here. And, of course, Aaron, the sustained support from 22 you is very much appreciated. 23 While I'm thinking about thanking people, I 24 would like to note the staff along the back and along the 25 walls here, our principal EPA people -- not all, butMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 26 1 they've been fundamental to the development of this 2 document, both the folks within the Office of Research and 3 Development as well as the colleagues in the Office of Air 4 Quality Planning and Standards and also General Council. 5 I had the pleasure last week of presenting 6 to a workshop in the European Commission and then the 7 European Provident about the way this process works with 8 CASAC, with the agency, both with Office of Research and 9 Development, with Office of Air and Radiation and with

10 OGC. 11 And it was used as a model both by myself 12 as well as Janet McCabe, who is the deputy assistant 13 administrator for the Air Office, as how science and 14 policy can work well together with a great benefit of 15 external peer review. And it was highlighted both by me, 16 by Janet McCabe and also by John Sammut who was there, who 17 was Chris's predecessor as the chair of the CASAC, that he 18 presented to the European Parliament members as, again, an 19 example of how the United States was doing this because we 20 benefit so much from having scientific expertise and 21 perspectives from CASAC. 22 So it was very well received by the 23 audience that were just principally Europeans looking at 24 how they can look at this year, which is the year of err 25 in the European Union as a way to move forward in terms ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 27 1 their standards as well. It's a lot of what's going on in 2 Europe as well now. They're looking at what we do here 3 very much.

4 So what I would like to do to move forward 5 is, in addition to introducing the staff on the sides and 6 in the back, is also Mary Ross is to the side. She is the 7 branch chief for the group that develops the integrated

8 science assessments. And then Ellen Kirrane who's our 9 team leader for lead assessment as well. So I'm very 10 pleased and honored to be working with these people as 11 well with all of you on the CASAC.

12 Where we are in terms of the timeline is 13 we're meeting today to discuss the third draft and your 14 comments on that, moving towards final revisions later 15 this summer, is what we anticipate. Again, we very much 16 benefit from the written comments and the summary letter 17 that the CASAC will provide to the administrator in moving

18 towards that. 19 It takes several months to consider your 20 comments. We already have gone through them and find a 21 number of very, very helpful points, many of which we, you 22 know, immediately embraced as these are helpful to improve 23 the documents. So we're excited about the benefit we get 24 from your perspective as well as this anticipated end of

25 the timeline for us.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 28 1 What this doesn't show, which you'll be 2 seeing later today, is the rest of the story in terms of 3 the development of the further timeline, which is the 4 policy assessment and the final rulemaking of the Office 5 of Research and Development staff. We stay involved in 6 this all the way through the very end. So while we may 7 not be prominent in the discussions that go forward, we 8 are very much supportive of the agency's rulemaking 9 procedures. 10 This is the team. Again, you can see it's 11 a large team. It takes a lot of people to create a 12 document, to review a document. In some sense, you're our 13 external team here. Again, we appreciate those efforts.

14 The ISA has been revised in consideration 15 of your comments on the second draft, and Ellen Kirrane 16 will be going through the revisions -- the highlights of 17 those revisions to give you some level of detail. 18 One of the things that has changed here -- 19 there's a number of things that keep changing -- is we're 20 trying to give somewhat more detail in terms of what we 21 have done in terms of changing the document. 22 And in our response back to your comments 23 in the second draft, we've provided some pointers, if you 24 will, pointing to where we have made specific changes in 25 certain sections to help you in your review. It's aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 29 1 substantial document, and we thought that would be helpful 2 to you. Again, I thank Dr. Frey for his suggestions to be 3 a little bit more specific than we have been in the past. 4 In terms of the legislative historical 5 background, as an example, we have added more of the pre 6 -- earlier history, if you will, as one of the comments 7 that we will see. And, again, I think that this provides 8 us with a coherent and comprehensive historical document 9 that reflects both the state of the science as it is now, 10 but also gives that context of how we've gotten here in 11 terms of the state of the science of lead for many, many 12 decades now. It's really quite an amazing story. 13 What I would like to do now is turn to my 14 colleague here, Ellen Kirrane, and she will go through and 15 highlight the major revisions that we've made to the 16 different chapters of the document. Ellen. 17 DR. KIRRANE: Thank you. So we have gotten 18 conclusions now from specific health endpoints in this 19 draft, and this is representative of a pretty major change 20 to the document. And we'll be considering ways to 21 optimize the endpoint groupings in light of today's

22 discussion as well as the written comments.

23 And we've also enhanced critical review of 24 the studies as well as the transparency of the application 25 of the framework for causal determinations. We've updatedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 30 1 Chapters 1 and 2 reports to reflect the changes that were 2 made to Chapters 5 and 7. But I'll cover more of the

3 details of those revisions when I talk about the later 4 chapters, even though the comments were received in these 5 chapters. 6 With regard to Chapters 1 and 2, we've 7 revised the language in the executive summary to be a

8 little bit more accessible to a non-technical audience and

9 added more cross-references because I think the Document 10 16 pages, hopefully it helps navigate. 11 So starting with Chapter 3, we've added a

12 lot more cross-references. And what we did was focus on 13 references between Chapters 3 and specifically 4.1 of 14 Chapter 4, which is the exposure section. For the source 15 section, we revised to clarify the relative contribution

16 of different sources of lead. 17 For example, we had Figure 3-5 that shows 18 point source facilities and airports estimated to emit a 19 half of ton or more per year when comparing the two. 20 And Figure 3.6, we have five-year totals, 21 in tons, for mining, production and imports and exports. 22 That was something that was done in the 1986 AQCD, and 23 we're able to update those figures. 24 For the Section 3.4, the monitoring 25 section, we have expanded both the table and theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 31 1 discussion of PM samples available for lead sampling. 2 In Section 3.5, the section on Ambient Air 3 lead Concentrations, we have moved a lot of the detail to 4 the appendix to improve the readability and brought back 5 modified versions of the tables that compare the 6 co-located lead measurements for different sampling size 7 cuts. We also have both the Pearson and the Spearman

8 correlation coefficients in the text sections of the 9 appendix that go with the section, lead in a 10 Multipollutant Context, and we've streamlined the 11 background section to focus on natural background. 12 Moving on to Chapter 4. This is the 13 chapter on Exposure, Toxicokinetics and Biomarkers. We've

14 clarified differences between the size distributions and

15 ambient air and lead and soil and dust. We've also 16 expanded the discussion of the contribution of air-related 17 exposure to total lead exposure; included more links 18 between Chapter 3 and Chapter 4, again. 19 We've expanded the discussion of the 20 relationship between lead exposure and biomarkers, and 21 also expanded discussion of blood lead, air lead 22 relationship as well as the uncertainties relating to 23 those air-to-blood slopes. 24 This is an example of a new figure that was 25 included in Chapter 4. The figure on the left actuallyMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 32 1 appeared in the first and the second drafts of the lead 2 ISA. It's Figure 4-11. And it shows a rapid decline in 3 the blood concentrations and subsequent return to baseline 4 levels following a period of elevated lead exposure. 5 And to respond to CASAC comments that the

6 ICRP lead biokinetics model wasn't consistent with 7 literature showing persistently elevated blood lead 8 following a period of high exposure. We added Figure 9 4-12. And this figure, you can see on the right, there's

10 a different scale. What it shows is that the model does 11 predict a more gradual reduction in blood lead following a 12 period of extended high exposure. 13 This is another figure that we've added to 14 Chapter 4. We expanded discussion of uncertainty in the 15 air-to-blood slopes as well as implications of particular 16 slope on predictions blood lead. This figure is actually 17 a modified version of the set of figures that were 18 provided in the CASAC comments on the second draft. 19 And we chose these three slopes because 20 they were used in evaluating their related IQ loss of 21 children in the 2008 final rule for the lead NAAQS. And 22 it shows the air -- the impact of these air-to-blood 23 slopes on the estimated change in air-related blood as a 24 function of change in the air lead. 25 And we also included a new table, it'sMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 33 1 Table 4-14, to demonstrate the effect of a child's age on 2 air-to-blood slopes. And we used a perspective study in 3 Mexico, Schnaas, et al., to create that table. 4 Moving on to Chapter 5. We've expanded the

5 critical assessment of the individual studies. For 6 epidemiology, this meant focusing on study design and 7 methods, potential confounding as well as reverse

8 causation. We've added details to the text and the table.

9 That should be evident in the redline version. And we 10 have strengthened the critique of the study design and 11 outcome ascertainment for ADHD in particular. 12 We have added discussion of potential 13 confounding by nutritional status and for hematological 14 and developmental effects, and we talk more about 15 potential for the reverse causation in both the renal and 16 the immune effects chapters. 17 For toxicology, we have made sure that it's 18 evident that we're focusing on the oral routes of exposure 19 and concentrations within one order of magnitude of human 20 blood lead levels, and the one order of magnitude is 21 described in more detail on Page 2-3 of the document. 22 And we talk about the animal toxicology 23 studies there, and the majority are below about 25 to 30. 24 We're not using that cut point of 10. These factors were 25 also evaluated and sort of drawn on more specifically asMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 34 1 we documented our conclusions in the tables of causal

2 determinations. 3 We've also improved -- or implemented 4 comments to improve integration and synthesis in the 5 health chapter. We've incorporated advice from experts in 6 neuropsychology and neurotoxicology that appeared on the 7 third slide. We've asked for their help on categorizing 8 the nervous system endpoints and drawing parallels in

9 behavioral constructs in humans and animals. 10 And we've also integrated more closely by 11 outcome the request of epidemiology and the toxicology 12 studies. And there's some examples here that appear in 13 the redline version, Executive Function and Inattention 14 and Impulsivity. 15 This slide shows -- is a comparison of the 16 conclusions that we drew in the second draft, comparing 17 them to the way made our conclusions in the third draft to 18 the ISA. Again, we've made conclusions about specific 19 endpoint groupings. And this table compares the two

20 drafts.

21 In the second draft we concluded there was 22 a causal relationship between nervous system effects 23 generally in lead exposure, but we pointed to cognitive 24 function and inattention in children as the endpoints that 25 were driving the causal determination. And this is --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 35 1 even though we have ten endpoints, the conclusions around 2 that are -- remain pretty much the same. 3 For cardiovascular effects, we're making 4 causal determinations for four groups of related 5 endpoints. In the previous draft we highlighted blood 6 pressure and hypertension. And now we also include 7 coronary heart disease, which is largely based on the 8 strong evidence from cardiovascular mortality studies. 9 And throughout these slides, the text 10 that's in red is there to note a change from the second

11 draft. 12 The endpoints and causal determinations for 13 other health defects are listed here. After reconsidering 14 the evidence for renal effects, we conclude likely causal 15 rather than causal in the third draft. Largely based on 16 uncertain things related to reverse causality. 17 For immune effects, in the second draft we 18 made our determination based on the strong evidence of the 19 Th2. In the third draft, we considered the evidence in 20 light of the endpoints listed here; atopic and 21 inflammatory conditions, decreases in host resistance and 22 autoimmunity. 23 The other outcomes are relatively 24 straightforward, and there's good parallel between the

25 second and the third drafts.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 36 1 For reproductive and developmental effects, 2 the sperm effects are in male reproductive function and 3 delayed puberty onset is within development. 4 To enhance transparency on the causal

5 determinations we included tables like this. This is an 6 entry for attention related behavioral problems, and it's 7 actually less detailed than some. We described here very 8 specifically evidence that went into our causal

9 determination.

10 And the column on the left will make the 11 evidence to the preamble where the framework for causal 12 determination is described. We left the key supporting 13 evidence in the second column, and in the third column we 14 note the key studies and the levels at which the effects 15 are observed on the far right. 16 We've received some comments about keeping 17 the text in these tables consistency -- consistent with 18 what's in Chapter 2 and also bringing in some of the 19 limitations of the blood lead levels to tables in Chapter 20 2, and that seems very reasonable to do. And I think the

21 level here that we left is the correct one for this 22 endpoint. 23 We have also incorporated a classification 24 system for at-risk populations, and that is based on what 25 was done for ozone documents. The summary of the factorsMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 37 1 that we've evaluated -- the summary table are listed here. 2 And we wanted to acknowledge one of the

3 comments that we received on the second draft of the 4 document, and that was to address the relative magnitude 5 or importance of the risk factors. Each of these risk 6 factors was evaluated to see if there were adequate 7 numbers of studies within each endpoint category. 8 And generally what we found is there were 9 not enough studies to actually look across the studies and 10 make any observations about the relative magnitude of the

11 effects. 12 We -- in the public health significant 13 section we highlight several studies, race and ethnicity, 14 genetic factors, and make sure in Chapter 6 that we 15 actually put the quantitative estimates. 16 But the problem that we're running into is 17 that for some of those studies, when you look across this 18 data -- for example, race and ethnicity, you see different 19 point estimates, but they're very overlapping. So we had 20 trouble relating observations quantitatively about what 21 the relative importance was. So we're looking for 22 feedback. It was our intention to respond to that 23 comment, and we're looking to -- for feedback in case we 24 have missed something. If you can recommend a different 25 approach, then we'll want you to do so.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 38 1 Moving on to Chapter 7, Ecological Effects. 2 The major revisions are listed here. In the first bullet 3 on as what's recommended, we're focusing on survival, 4 growth and reproduction and the sub-organismal responses 5 are secondary. We added the summary tables, and those are 6 for survival growth and reproduction and endpoints. 7 We've included the media-based exposure 8 concentrations and the modifying factors in those tables. 9 We've also increased synthesis and technical evaluation 10 and clarified language in the causal determinations 11 linking back to those enhanced technical evaluations. And 12 all the units should be standardized in the chapter. 13 Another important change in Chapter 7 was, 14 again, in response to CASAC comments. In the second draft 15 we had a causal determination of aquatic effects 16 generally. We broke out the freshwater and the saltwater. 17 And, again, the causal determinations that are in red are 18 the ones that have changed. And you can see under 19 saltwater there are a lot of inadequates, a few 20 suggesteds.

21 And the reason -- and the freshwater 22 effects were the effects that were driving the causal 23 determinations for aquatic effects. So a few of those are 24 highlighted in red. 25 So those are the major revisions that weMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 39 1 wanted to call your attention to. And we'll hand it back

2 over. 3 DR. FREY: Okay. Well -- yeah, Dr. Kirrane 4 and Dr. Vandenberg, thank you very much. This is a very 5 nice presentation, and I like especially that you're kind 6 of walking us through what's changed and showing us some 7 of these tables and examples of the details and also 8 bringing up comments that you want to respond to but are 9 having challenges in responding to. And I think that 10 helps us focus on where we can help you the most. I 11 appreciate this presentation. It's very nice. 12 At this point, we're at the part of the 13 agenda where we begin to discuss the individual charge 14 questions since we don't have public comments at this 15 point. And as mentioned earlier, if there are -- there is 16 an opportunity for clarifying comments from the public 17 later this morning on the integrated science assessment. 18 If anyone is -- from the public would like to make 19 comments, they should contact Mr. Aaron Yeow, the 20 designated federal officer. 21 With that, let's move directly into the 22 discussion of the charge questions. First, we will 23 discuss the preamble, the legislative and historical 24 background, the executive summary, which is Chapter 1, and 25 the integrative summary, which is Chapter 2. And the leadMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 40 1 discussant on this is Dr. Michael Kosnett, and the other 2 designated discussants are Dr. Michael Rabinowitz and 3 Dr. Ian von Lindern. But there will be an opportunity, if 4 other members have comments, we'll -- we will have that 5 opportunity as well. 6 And just as a reminder, I would recommend 7 -- highly recommend and encourage that the lead 8 discussants plan on doing some homework tonight to try to 9 draft a first version of the response to charge questions. 10 So if you have written material that supports your public 11 oral comments during the discussion, please e-mail that to

12 the lead discussant. 13 And just recall some of the rules for 14 communication with panel members. Since we're a federal 15 advisory committee, we can't have deliberations that are 16 not in public. But it is okay to send information to a 17 limited number of other panel members as long as you copy 18 the designated federal officer, Aaron Yeow. And I would 19 appreciate also if you would copy me as well. 20 So with that, I'd like to turn the floor

21 over to Dr. Kosnett. 22 DR. KOSNETT: Thank you. 23 DR. FREY: And by the way, you have 20

24 minutes. 25 DR. KOSNETT: Yeah. Well, this was a realMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 41 1 easy chapter to review, Chris. It only covered 2,000 2 pages in summary, so... 3 You know, I'll say some things here, and 4 then some of my comments, I guess, came up -- or should be 5 brought up in more detail on Chapter 5 because that's an 6 area that I am particularly interested in. 7 I do think that it was a very positive 8 finding that this document, as Dr. Frey pointed out, you 9 broke out various specific endpoints. And that is really 10 helpful. And I also thought, although you don't do it so 11 much in Chapter 2, but in Chapter 5, Table 5-17, you lay 12 out your assessment for how you went about -- you know, 13 this is the evidence and this is the consequential 14 evidence. So that -- I think that was very, it was very 15 helpful. 16 I think a larger issue that I'll mention 17 that I -- and I wanted to ask my colleagues on the panel 18 how they feel about this. It relates to the causality 19 assessments. One is a more general approach, one is -- 20 has to do with a particular influence. 21 The general approach is, you know, you have 22 -- it's clear -- it's pretty clear that when we say 23 there's a causal relationship -- and this is spelled out 24 in Chapter 1. I may have seen it in the preamble. You 25 have to have multiple high-quality studies that hangMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 42 1 together, and you have to have positive toxicological 2 support. 3 I think we're all in agreement, okay, we're

4 close. But then we -- to me it becomes a little bit more 5 unclear how you determine something is likely causal 6 versus suggestive. And I was going through some of these 7 endpoints. Like for example, this document concludes that 8 the hematological effects of lead likely cause. And if 9 you look at hematological effects, it's like ATP and ALAD. 10 Now, I can only speak for myself and maybe 11 others around the room. I have a lot of experience with 12 lead. You know, asthma and ATP and hematologic issues are 13 not really something that has -- that comes to attention 14 in lead-exposed children and adults, at least in my 15 experience. And I'll leave -- you know, maybe 16 Dr. Weitzman and Susan here may say something here on 17 that. But, you know, we don't -- we don't -- it doesn't 18 normally come to the floor. 19 And, in fact, I'm on the CDC committee, and 20 Debbie is too. And our whole document we recently put out 21 about, you know, the whole issue of level concern. We 22 don't mention hematological effects at all. 23 But this document says that the 24 hematological effects are likely causal. So if you look 25 into it, it's all based on animal toxicology. It's notMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 43 1 based on human epidemiology for the most part. There are 2 one -- I should take that back. There's one particular 3 study -- epidemiological study that has found a link 4 between asthma and lead. And I believe there's questions 5 about controlling social and economic status and such.

6 But then I realize under the framework for 7 causality right here, that's sufficient. You can just 8 have good animal studies, and the epidemiology doesn't 9 have to be very good and we can say likely causal. 10 And I don't know if -- you know, another 11 thing I wanted -- that comes up is the cancer assessment. 12 The cancer assessment here, it says, lead is likely 13 causal. It causes cancer, in humans. Well, I -- I think 14 people would take that away, that it could cause it. And, 15 you know, that's mainly -- the epidemiology -- the human 16 epidemiology is very inconsistent. There are some animal

17 studies that indicate that lead causes cancer in a certain 18 animal systems, but that's enough in this document to say 19 likely causal. 20 Now, I went back and thought, Well, what 21 does IARC say? How does IARC put it together? And IARC 22 looked at the same evidence that EPA has, and they said 23 their -- they come down to it produces limited evidence of 24 causing cancer. And they say limited evidence of causing 25 this. There's a positive association that has beenMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 44 1 observed between exposure of the agent, mixture or 2 exposure circumstance in cancer for which a causal 3 interpretation is considered by the working group to be 4 credible, but chance, bias or confounding could be -- not

5 be ruled out with a reasonable conscious. 6 And if you look at the evidence for -- 7 under likely causal, and I'd like to keep that for my 8 colleagues here at EPA, we look at that. It's not clear 9 to me that if we felt that bias or confounding could rule 10 something out, at least in the human studies, are you just 11 saying that it's still likely causal because the animal 12 studies are positive?

13 MS. ROSS: So it is true that the animal 14 studies -- and this preamble is reflecting that to us.

15 These assessments could also -- the kind of considerations 16 we do in other toxic pollutants where we often don't have 17 (unintelligible). So I think one of the things we 18 recognize here, and it's true in ours too, is that animal 19 data can provide important support for a determination. 20 Without a live human data, we have to look at them 21 together. 22 So if there's strong animal support, but 23 just limited data available for human studies, that can -- 24 that can inform determination. It's not required that we 25 have any one type of data. We try to look at them --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 45 1 whatever we've got to get some -- 2 DR. VANDENBERG: I might add just a little 3 bit. And that is that as we develop that framework, we

4 looked at the Institute of Medicine and we looked at other 5 frameworks, including the EPA's cancer guidelines. And 6 this is consistent with the cancer guidelines that EPA has

7 created in 2005. 8 DR. KOSNETT: Okay. 9 DR. VANDENBERG: So, again, the language 10 that you see is not identical across the frameworks. 11 DR. KOSNETT: Right.

12 DR. VANDENBERG: So -- 13 DR. KOSNETT: So I guess my recommendation 14 -- and I'll be interested in hearing what other people 15 have to say -- is that particularly in that likely causal 16 suggestion, that the human data is really not driving it 17 all and it's being given by the animal data. In the 18 executive summary and in the integrated summary in Chapter 19 2, which a lot of the policy readers will read, make that 20 a point. You know, make that explicit. 21 I mean, you can hunt -- you can go to Table 22 5-17 and sort it out, but it's good -- it's best to be 23 clear on that, I think. 24 DR. VANDENBERG: Can you tell -- exactly be 25 clear about what? Let me just make sure I understand.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 46 1 DR. KOSNETT: Well, where do you make the 2 decisions on likely causal based on the animal data being 3 the reason for that, even though the human epidemiology is 4 inconsistent. I think that should be emphasized, 5 particularly with lead. I'll tell you why, because with 6 lead, more than most substances, we have a lot of human

7 data. 8 MS. ROSS: Yes, we agree. 9 DR. KIRRANE: Yeah. I think we can bring 10 that forward, and it needs to be consistent. I think that 11 was another point in your comments. 12 DR. KOSNETT: And then the other point, 13 specifically, have to deal with -- about this causality 14 issue. It had to deal with two particular influences. 15 One is the renal and one is the behavioral aspect. 16 Focusing first on the renal, I notice that they changed 17 the assessment from causal to likely causal, which is the 18 downgrade. And you recognize and have a discussion in 19 Chapter 5 on reverse causality. 20 I think -- you know, I appreciate the fact 21 that those changes were made, and I had argued last time, 22 you know, for that. I -- but, again, if you wanted to 23 parse out the evidence in terms of whether it should be 24 suggested for likely causal at low levels of exposure, you 25 know, the human epidemiology, I felt, was inconsistent.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 47 1 There are some studies that show a 2 relationship of low levels, and there are some that do 3 not. There are some occupational studies that actually

4 show an increase in creatinine clearance with elevated 5 lead. Now, that has been tried to be explained through 6 equal positive hyperfiltration. But that, that's a 7 post-doc explanation. It's not clear that the blood 8 causes hyperfiltration. 9 DR. KIRRANE: Can I just ask a -- you said 10 low levels. Can you specify what you mean? 11 DR. KOSNETT: I'm not talking -- I mean, 12 I'm not -- I'm talking about the environmental exposure 13 that has occurred in, let's say, the United States in the 14 past 30 years, which -- 20 or 30. Okay. I'm not -- I'm 15 not talking about lead and nephropathy in high dose. I 16 mean, I know -- I'm very clear that lead causes 17 nephropathy in humans in high doses. 18 I'm talking about there is some literature, 19 which maybe you probably know, that suggests that blood 20 lead concentrations of 5 micrograms are associated with 21 decreased renal function. I say associated because that's 22 just with an epidemiological association. 23 Now, the human data is inconsistent in 24 terms of the epidemiology. There's some studies that show 25 that and some studies that don't. The animal data clearlyMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 48 1 shows that at elevated levels there's nephropexy toxicity.

2 There are no animal studies that have shown effects of 3 blood lead levels below ten, I don't believe. 4 DR. KIRRANE: It's 25 to 30, though, right? 5 That's on page -- we talk about looking at the informative 6 toxicology studies that are below 25 to 30. 7 DR. KOSNETT: Okay. 8 DR. KIRRANE: We can -- we need to clarify, 9 and there are studies in that range. 10 DR. KOSNETT: In that range. There's none

11 below ten?

12 DR. KIRRANE: Correct. Yeah. But it's 25 13 to 30 that we're setting up our approach.

14 DR. KOSNETT: Related to the animals?

15 DR. KIRRANE: Yes. 16 DR. KOSNETT: Okay. Okay. And there's no 17 human -- there's no pathological mechanism that's been 18 identified in terms of like biomarkers of renal toxicity 19 or pathology at these very low levels. And so some people 20 have said, Well, you know, inconsistent epidemiology, no 21 pathological evidence. What about the issue of reverse

22 causation? 23 And you addressed that in that chapter, but 24 the issue -- I must say -- and I know we don't have time 25 for me to go through all the details about reverseMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 49 1 causation, but when you -- the arguments that are set 2 forth all have counter-arguments. And I think it's an 3 improvement that the discussion is in there, but I think 4 that the discussion still says it's unlikely that -- the 5 gist of that discussion says it's unlikely reverse 6 causation. It exists, so, well, there's a possibility. 7 So I was -- I was thinking in light of all 8 that, why -- why are we saying it's likely causal and not 9 suggestive. If we have the epidemiology, it's -- it's 10 what it is. It's inconsistent. There's no toxicological 11 mechanism at low doses, so like less than ten. And 12 there's an acute concern about reverse causation. Maybe 13 it should be suggested. 14 And then, finally, the point about

15 behavior. I mentioned attention issues. I think that -- 16 if you notice in Chapter 2, when it makes these 17 assessments about behavior, it doesn't say anything 18 specifically in the chapter about dose, about blood lead 19 levels. And there seems to be two different groupings of 20 studies about behavior. In fact, you have -- can you put 21 up that slide you had on transparency, please. That was

22 table -- it was -- 23 MR. MCNAMARA: I've got it. Just give me

24 one moment.

25 DR. VANDENBERG: It's Slide 16.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 50 1 DR. KOSNETT: The interesting thing I saw 2 there was that -- if you notice, the studies that -- the 3 consistent epidemiology is -- a lot of it comes from the 4 work that's been done on -- generally on populations that

5 have blood lead levels above ten in the studies that were 6 done in the early '90s.

7 The studies that were done with children 8 with blood lead levels below ten, the epidemiological 9 studies have not been -- well, there are two types. 10 There's the study that Gail did and the study that Rich 11 did, the two people that are here. And the evidence -- 12 you notice that the -- in the middle there, you see where 13 it says Wasserman, et al., and Canfield, et al. And they 14 say, Association with inattention ratings inconsistent in 15 prospective studies examining children with lower blood

16 lead levels.

17 So that -- those studies are inconsistent 18 at a lower dose. The studies at a higher dose, above, you 19 notice those are studies from the '90s, for the most part. 20 And they look at -- they've looked at higher lead levels. 21 And then you have the more recent and cross-sectional 22 studies, which are mainly of the ADHD type. But then the 23 question there is -- a lot of it has been the problems 24 with not measuring confounding by parental 25 psychopathology, which is a big issue in the lead-relatedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 51 1 behavior effects at this time or the other. 2 So my sense is, and this is maybe -- this 3 is parsing it out, and I'll say this and I'll stop. My

4 sense is that shouldn't the document subdivide the causal 5 assessment for behavior in saying that levels above ten, 6 it's likely causal. Like, at lower levels, the evidence 7 is still just in the suggestive range because the 8 epidemiology is not as established. There's no toxicology 9 in animals below ten. Debbie, right? I mean... 10 DR. CORY-SLECHTA: Yeah, there is. 11 DR. KOSNETT: Okay. Below ten? 12 DR. CORY-SLECHTA: Yeah, attention-related

13 behavior. 14 DR. KOSNETT: In attention? Okay. All 15 right. Well, that's why I asked you because I know you're 16 familiar with that. But I just think that maybe the 17 issues -- I mean, I guess the bigger point is, is that you 18 don't -- the document doesn't break down in Chapter 2, in 19 the summaries, about the -- where -- at what level of 20 concentrations we're seeing these causal relationships. 21 And for the neurocognitive effects, it's 22 very clear that we're seeing them in temporary levels, in 23 the levels around where the standard has an impact. I

24 don't know that the behavioral evidence is on the same 25 par, or the attention level is on the same par and whetherMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 52 1 we should point that out. And I'd like to hear feedback 2 from my colleagues now. 3 DR. KORRICK: I just have one comment. So 4 Rich and Gail can comment on this, but in terms of 5 concurrent blood lead levels, the study -- the Canfield

6 and Wasserman studies are similar in their concurrent 7 levels with the standards in the '90s, correct? They're 8 the 6's. These are not super -- Gail's and Rich's were 9 super loads with kids, right? 10 DR. KOSNETT: Well, less than ten. 11 DR. KORRICK: Right. But they're 12 concurrent levels in the '90s reference. So if you look 13 at the summary, the transparency summary -- 14 DR. KOSNETT: It's Bellinger's model. 15 (WHEREIN, unintelligible due to multiple 16 people speaking at once.) 17 DR. CANFIELD: The children had higher lead

18 levels.

19 DR. KOSNETT: Yeah. But the concurrent

20 lists were not all that different. So I think we should 21 probably stem with her meaning, something that's specific.

22 But I think that it's a little bit of an 23 oversimplification to say it's all adults and children. 24 I mean, I think one of the other things 25 that's different about Wasserman and Canfield is you guysMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 53 1 looked at younger kids. You looked at four to five year 2 olds, which are very different ages to assess these things 3 than older school-age kids, which is what most of the 4 earlier studies did. So I think the comparisons are more 5 complicated than just saying it's a function of lower dose 6 versus higher dose. And I think that would be in the rest 7 of the literature. I don't think it's that simple. 8 But that's -- you know, I just want to put 9 that -- I think, you know, it's a complicated for all of 10 us to try to figure out what were those other 11 contributions of all of those issues. Age assessment is 12 as important as well as the exposure. I mean, I think 13 it's not just a simple statement. But others should

14 comment here. 15 DR. CANFIELD: Yeah. And so I would agree

16 with those comments. And also there's a difference in 17 your attention measures for your -- a variety of the 18 attention measures and variability simply in the quality

19 of the measures. And I've used some measures that were 20 more experimental in their use, and maybe not as accepted

21 as other measures. 22 They're certainly not on the same par as an 23 IQ. So to try and put all the attention that isn't 24 related to it in categories is quite problematic because 25 some are more pure attention tests and some are more pureMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 54 1 behavioral subregulation or externalized or something to

2 that effect. 3 So -- I mean, I didn't make a submission to 4 the category, but I do think that it's variability among 5 the attention measures as well as age, as well as those 6 all involved. So it -- I think it's great we're having 7 this discussion, by the way. The fact that we get into 8 this point about, you know, really what's the quality of

9 the evidence is where we want it to be. So I think that's 10 really good. 11 My question for the whole panel is, Is 12 there a place that we say this is about as good as we can 13 do given what evidence is out there because we don't have 14 all the studies from all the cells to give us a 15 perspective on how much is age, how much is the particular 16 measure, how much is the dose. Gail, any comments? 17 DR. WASSERMAN: Well, I would agree. I 18 think we've come a very long way in terms of being able to 19 parse out or to describe the complexity of the outcome 20 measure attention versus componsitionality versus 21 diagnosis. And there isn't the same consistency as there 22 is in measuring IQ. You know, we'll have pretty

23 consistent measures. So there's a lot of causes for that 24 variability. I think they're accurately presented in 25 Chapter 5. So the issue is how much integration we needMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 55 1 to pull together here. 2 DR. WEITZMAN: I concur about the quality 3 of what it is that we're trying to do. But as we try to 4 be consistent, there are multiple other pristine groups of 5 experts that weigh in on these things. How important is 6 it that we acknowledge that there are similarities or 7 differences in conclusions that bridge or as compared to 8 other important public groups. 9 As a clinician, I can tell you that the 10 American Academy of Pediatrics will write a policy 11 statement. And if there's inconsistency within the CDC 12 statement, what does that do in terms cognitive issues? I 13 believe that's important to other clinicians.

14 DR. CORY-SLECHTA: I don't think that the 15 new CDC recommendations are very specific with respect to 16 eliminating the phrase level of concern because we're 17 finding effects at the lowest blood lead levels that we 18 can reliably measure. And we describe some of the

19 evidence. That document was not intended to be a 20 comprehensive review, so we don't hang our hat, if you 21 will, on which of those effects. And then we set a

22 reference level from that. But I don't think it would be 23 inconsistent with what was suggested here. 24 DR. WEITZMAN: But I think that's important 25 having authored the previous CDC statement. I believe theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 56 1 first author -- we did try to be as careful as we could in 2 trying to come up with levels of evidence. And so going 3 forward, is this something that we want to do? I'm not 4 talking about something that's extreme, but simply a 5 couple of sentences, perhaps, to say what Debbie just said 6 in this particular document. I may be off.

7 DR. VANDENBERG: Can I comment to that 8 question?

9 DR. FREY: Yeah. Sure. Go ahead.

10 DR. VANDENBERG: So this review is for -- 11 you know, for this purpose, as you see in the framing of 12 it, how we constructed the framework for evaluation, the 13 nature of the way that it's in the literature. It is not 14 identical to what we did, for example. It is just 15 limited. CDC is sort of for their own purposes. Any 16 cross-comparison, it's not so likely here as it may be at 17 subsequent other considerations. So I don't know that I 18 would suggest to find ourselves constrained in this 19 document by what other bodies have done, whether it's IARC 20 or CDC or any of the others. 21 This is the document that's getting 22 reviewed here. I would look at the way we have framed it 23 and the way we've applied the evidence to that framework. 24 It's really the structure for this particular discussion. 25 DR. FREY: Yeah, go ahead.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 57 1 DR. CANFIELD: Yeah. I think there's one 2 other angle to this, which is it would be -- I think it

3 would be useful to look at the other current documents as 4 providing some help and just another perspective on issues 5 like the ones that Dr. Kosnett was bringing up in terms of 6 likely versus causal versus suggestive. 7 Because those are judgment calls, and there 8 are so many different dimensions to this literature that 9 if you're focusing on these three or four dimensions and 10 not remembering, you know, Dimension 8, you might come up 11 with a different perspective than if you really are 12 thinking about, you know, 8, 6 and 5 -- or something like

13 that. 14 And so other people might be focusing a 15 little bit more on other aspects of the data and providing 16 just a check to say, Oh, yeah, I see what they're 17 thinking, or I more agree with what I did. This is a very 18 sophisticated document, and you've done a great job. And

19 I think the one level -- and this relates also to

20 Dr. Kosnett's remarks. 21 One aspect of the causal determination, I 22 think might be causing some confusion or a sense of 23 inconsistency, is -- there doesn't seem to be a specific 24 way to incorporate information about inconsistencies, say, 25 within a study.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 58 1 For example, in large studies we may find 2 an effect on one measure, but not another. And you can 3 take that as evidence for, you know, this effect is 4 powerful and yet all the statistics we need and very 5 controlled, but why didn't we find it somewhere else.

6 And I think one reason for this that isn't 7 stated in the document in general is typically small 8 sample sizes. That's causing a huge problem throughout 9 this in -- I think in terms of consistency. It makes it 10 impossible for you to do your job when there's so much 11 noise in the data due to small sample sizes.

12 But the notion of what counts as 13 consistence or inconsistence is not explicit here. And, I 14 mean, it's a -- well, it's a huge amount of work to go 15 into every study -- even in a more detailed way than you 16 already have. It's just like impressive. 17 DR. FREY: Okay. I guess one thing I'm -- 18 and I'm not -- I don't have the domain expertise that the 19 discussants on this have, so I -- but one thing I'm trying 20 to figure out from the discussions, what are we going to 21 write for the answer to the charge question. 22 And so I'm -- something I'm -- just to kind 23 of reflect back what I think I've heard is -- one thing is 24 that a causality determination is context dependent, and 25 it matters -- it is affected by things like dose, age,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 59 1 what metrics are used and so on to Dimension 8, where 2 others -- and that for EPA's purpose they actually could 3 legitimately reach a different causality determination for 4 their context than another agency might reach for another

5 context. I think I've heard that. 6 And if that's true, then maybe that could 7 be discussed in the document just to make that clear that 8 if anyone wants to compare this to IARC or others, they 9 should do so very carefully because they're not really 10 comparable. They're not answering the same question. 11 And so maybe part of the advice is just to 12 be very clear about that. Is that an accurate -- and then 13 I think there were issues about the specific 14 interpretations Dr. Kosnett pointed out, whether something 15 should be likely causal or suggestive. And then some of

16 those decisions need to be reconsidered or at least more 17 clearly justified. 18 DR. KOSNETT: Yeah. Does anyone -- I mean, 19 do -- are people comfortable with calling renal likely 20 causal, or do you think it should be suggestive? The same 21 thing with behavior. I don't think there's a question 22 that the higher doses would give you. I'm just wondering

23 if the lower doses would be an issue confound and has not 24 been as clear. But I -- I don't want to say that if other 25 people aren't comfortable with it. That's why I want toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 60 1 get feedback on it. 2 DR. FREY: Yeah, and it could be that on 3 that issue -- I don't know that we were kind of -- I guess 4 if no one's objecting, I don't know if that means consent 5 by not objecting. But I guess if anyone takes issue with 6 whether there is uncertainty regarding that -- those two 7 choices of classification that it might be useful to 8 discuss that, but...

9 So in terms of the comment that we could 10 convey to EPA, it could either be just to raise that as an 11 issue that needs more attention, or if the panel feels 12 like the panel wants to advise on what the decision should 13 be on that as opposed to giving the EPA the latitude to 14 revisit that, I think that -- that's a decision we need to 15 make and convey our advice. 16 But what I would suggest -- we're kind of 17 behind schedule, but I suspect we're really not behind 18 schedule because as you pointed out at the beginning, 19 Michael, that some of this touches on Chapter 5. And I 20 think it was a very good discussion. So I'm optimistic 21 we'll still finish by lunch. 22 But I do want to give the other two 23 assigned discussants their opportunity on this charge 24 question. So let me offer the floor to Dr. Rabinowitz. 25 DR. RABINOWITZ: Thank you very much. AndMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 61 1 I have a feeling, to some extent, that the horse is kind 2 of out of the barn. No matter what we say, things are 3 going to kind of go along the fence. Despite that, I have 4 some minor comments to make. Maybe I'll just bring one of

5 them to the floor. 6 Of course, when we talk about -- we can 7 press the charge questions. If I could just bring your 8 attention (unintelligible). And that's regarding -- well, 9 it seems like we're wrestling here a bit with causation 10 and confidence and how we can express that in a document. 11 And the epidemiologists, of course, have 12 dealt with this a long time. The legal profession also 13 deals with confidence in making judgments. And I'm not a 14 lawyer, maybe there's no lawyers in the house. But I can 15 -- maybe? Is there a lawyer in the house? That's okay. 16 I -- well, it's always good to have one. So I stand ready 17 to be corrected by what I say. 18 It seems like the legal profession deals 19 with this by coming up with concepts of things are more 20 likely -- more likely guilty than not. Things are more 21 likely true than not. You don't have to be 100 percent 22 sure, but in civil cases you just have to be 51 percent

23 sure. 24 Maybe we can incorporate that kind of 25 thinking into how we address all things here. Well,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 62 1 things are more likely -- lead is more likely to cause 2 this effect than not. And then you go on to a more higher 3 level of confidence where beyond a reasonable doubt lead 4 causes it. Maybe that way of thinking about how to 5 express more uncertainties might be useful in this

6 context. 7 Having said that, did I -- could I ask you 8 to turn briefly to Page 114 on Line 3. And it's just 9 something here, and it may be just a typo. It just kind 10 of caught my attention. Where it talks about the larger 11 effects -- where lead has a larger effect at lower doses. 12 And I think we all believe that more lead equals more bad, 13 generally, regardless of the -- of what you're looking at,

14 whatever the outcomes are. 15 But here it says that the effect is greater 16 at the low dose, and I think there's some confusion here. 17 You may want to say that the rate of change in the outcome 18 is greater at these low doses of lead. The line is 19 steeper at these low doses. But this occurs from time to 20 time in documents. And I think what we need to say is 21 that maybe lead causes a greater incremental effect rather 22 than lead causes a greater effect. I think that's what

23 needs to be corrected there. 24 Later on we'll get together and talk about 25 what to give you later for the charge questions. As aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 63 1 general comment, though, I think you can say better and 2 better, how good does it have to be to say it's good 3 enough. I think it's almost good enough. 4 So in my other comments -- even though it's 5 not listed -- for instance, there's some diagrams in that 6 -- I believe it's in Chapter -- in the summary. There's 7 all these possible sources of lead, and they're all 8 equally large in the diagram. We all know in real life 9 some are bigger than others. I know this must be just a 10 schematic diagram. If there's any way to make the 11 extended exposure show up graphically, it just might help 12 the less informative. Those are my comments. Thank you. 13 DR. FREY: Okay. Yeah. I think I would 14 comment that, you know, operationally I think we as a 15 panel serve -- naturally fall into the notion that we need 16 to include ISA, and is it good enough and so on. That's 17 not a particular mandate of CASAC. We can provide 18 comments, and I think we -- we iterate and we want to see 19 the comments addressed. It's kind of like a journal 20 paper, I suppose. It's something we -- you know, do we -- 21 do we just offer comments, or do we make a decision on 22 acceptance or rejection. There's a distinction between 23 those two things, I think. 24 I just mention that just because I think we 25 don't necessarily have to bless or say we approve whatMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 64 1 they might say, but we do provide our feedback. And I 2 think there is a burden on the EPA to either respond to 3 the comments by changing it or explain why they didn't. 4 But, yeah, at some point maybe we can reach 5 that threshold where we're willing to let it slide. Yeah.

6 DR. VANDENBERG: I'd like to make a comment 7 about that. In many of the previous reviews, sort of the

8 final letter that the CASAC writes to the administrator 9 regarding whatever that final draft is, it's often been -- 10 a sentence has often been included by the chair which is 11 that the CASAC finds the document to be adequate for its 12 intended purpose. 13 DR. FREY: Right. 14 DR. VANDENBERG: But it's along those

15 lines.

16 DR. FREY: Yeah. 17 DR. VANDENBERG: It's not a yes, no. It's 18 just is it adequate for its intended purpose. And, again, 19 that speaks back to the idea that in the context in which 20 we were working with, this document has a certain purpose 21 to support ultimately the rulemaking. So that might be 22 something for you to consider as the chair. 23 DR. FREY: Yeah. Yeah. That's a good 24 point. Dr. von Lindern. 25 DR. VON LINDERN: Thank you. I'd like toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 65 1 say I concur with my colleagues' earlier comments, but I

2 concur with Dr. Rabinowitz. But I have to defer to 3 Dr. Kosnett on that discussion because it's beyond my 4 expertise. And I do want to commend the staff for a great 5 document. I think it helps create a success story in the 6 country wealth. They brought together a tremendous amount 7 of declamation, synthesized that well and done a good job 8 for the purpose of the document. 9 But, as you know, my problem is with the 10 scope and that it's narrow. I think as opposed to the 11 earlier process, the history and summary is a great 12 addition. That helps offset that somewhat, but I'll give 13 a little personal example. 14 This is my fourth time going through this 15 process. And because I'm an engineer and there's not very 16 many engineers on this panel, I always get assigned to the 17 sources category. 18 And the first thing we used to do in the 19 sources category was assess production, use, consumption, 20 disposal and role of lead in society. And we prepared 21 that information, and that was available in the document 22 for the policy reviewers to assess. In the 2006 process I 23 complained that that information was too sparse and it 24 needed to be developed. And the truth of the matter is, 25 is you won't find that information in the peer reviewedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 66 1 literature. You'll find that information in trade 2 literature, and you'll find it in the regulatory programs. 3 EPA used to pursue that. It used to 4 collect that data, and it used to analyze it. And 5 frankly, you could bet that was the industry. The 6 industry would back that information because they had an 7 interest in it, and they were on these panels. 8 And we, in the document -- the agency then 9 provided the policymakers a view of that aspect of the 10 problem. Well, what -- what the agency has done now is 11 totally eliminated. There's not a single word in this 12 document about production, use, consumption, disposal of 13 lead in the United States. There's lots of suggestive 14 evidence that the United States uses more right now than 15 it did during gasoline additive days, but we seem to 16 totally ignore data. 17 Now, the history does portray a huge public 18 health success, but history does not portray that that 19 production, that use, that consumption, that disposal has 20 gone on at greater levels than it did when we began this 21 process four years ago.

22 And there are more children in the world 23 today that suffer lead poisoning directly or indirectly as 24 a result of this policy. And we have totally ignored 25 that. It's not in this document, and the information isMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 67 1 not available for the policymakers when they review and

2 make a decision. 3 Those are really policy issues, so I'll 4 quit there and take this up again at the next round.

5 Thanks. 6 DR. VANDENBERG: Can I say something? 7 DR. FREY: Yeah, John. 8 DR. VANDENBERG: Yeah, one of the things -- 9 we did hear your comments before about this and have added 10 some additional figures that Ellen pointed in 3.6 which 11 does deal with mining primary and secondary production, 12 imports and exports. So I think we've heard your 13 concerns. Perhaps, not globally, but we've added what 14 information we could bring in to try to speak to some of 15 your concerns. I don't want you to feel as though we've 16 ignored your comments. 17 DR. VON LINDERN: No. And I want to, 18 again, stress that I think the staff has done a great job. 19 I just think the agency and, frankly, our federal 20 government have ignored this issue. This forum used to 21 provide a great deal of information for that, but you did 22 not have the opportunity to develop this time around the 23 federal changes of decisions. 24 DR. FREY: Okay. Other comments on this 25 first set of charge questions?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 68 1 (No response.) 2 DR. FREY: Okay. So Michael, do you feel 3 like you have a roadmap for drafting the initial response 4 to the consensus view on the charge questions? Is there 5 any other input you need from the panel? 6 DR. KOSNETT: Does anyone want to say 7 anything about the renal? 8 DR. CANFIELD: I could give my perspective 9 on -- I think your issue is that -- I think the current 10 classification, the causal classification is acceptable 11 and defensible. I think other judgments could also be

12 defensible. 13 But I think what's most important is that 14 the framework is explicit, and the evidence that they're 15 using to support their judgment is explicit. And there's 16 no mystery here except one person sees the glass half 17 empty and the other sees it half full. I kind of see it 18 boiling down to that.

19 So even if I would not feel comfortable 20 with likely causal, I know what the judgment is based on 21 and I see that it fits their criteria. And maybe I would 22 go back and say, Well, you could prove the causal 23 determination criteria, but I don't think this is the 24 place to do that. So that's my perspective. 25 DR. FREY: Okay. Anybody else?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 69 1 DR. KOSNETT: So we can say that we 2 compliment, certainly, and be appreciative of the fact 3 that it's more transparent. That would be recognized that 4 they are judgment calls on certain cases that say it was 5 likely or suggested. But the important point is we agree 6 to pinpoint, and that might not be resolvable. But we 7 appreciate the fact that there's more transparency. 8 DR. WEITZMAN: Well, could it be any less 9 than transparent? We've put together an explicit 10 criteria, but that explicit criteria is dependent upon 11 consensus, right? It's not quantitative. It looks like

12 it's clear cut how one reaches a determination about cause 13 and likely. If people are saying -- you disagree?

14 DR. KOSNETT: I don't know that -- if 15 there's -- if you look at the difference between 16 suggestive and likely -- suggestive evidence of causality 17 and likely in the preamble, it's not very clear to me -- 18 DR. WEITZMAN: Yeah, I think that's what I

19 said. 20 DR. CANFIELD: I'm just thinking that we're 21 sort of litigating the philosophy of science rather than 22 this particular application of a consensus of how to talk 23 about causality because there's no -- we're not going to 24 get actual approved causality. We're not getting there, 25 but we're going to have various schemes. And, of course,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 70 1 they have to be things that we agree on.

2 And if it's a consensus that this is a

3 reasonable scheme -- not that there couldn't be other 4 schemes or maybe another group might come up with another 5 scheme or apply it slightly differently. I just feel like 6 we're probably at -- I mean, I have suggestions for things 7 that make me uncomfortable, but I guess I'll propose that 8 this is probably as good as we're likely to find for this 9 kind of an application.

10 And I don't know these kinds of reviews

11 because this is the first time I've served on. I think 12 that this is pretty impressive and it goes a long way, and 13 there are a lot of people in the world that are going to 14 learn a lot about lead if they take a look at this. That 15 doesn't mean that, you know, whether it was -- you know, 16 whether it should have controlled for common knowledge -- 17 you know, when I did that analysis -- or not. 18 You know, I can't decide whether I really 19 should have done that or not, you know. So -- but I got 20 consensus of my co-authors. 21 DR. FREY: Okay. So I think I'm hearing

22 two levels of discussion. One is more about the -- I 23 guess the aspects and criteria for causality, which I 24 suspect we're not really wanting to open that as an active 25 area for further changes. And then another isMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 71 1 interpreting that in the context of our particular case, 2 and I think Rich offered a way forward in commenting on

3 that. 4 And I think when you're kind of near the 5 boundary of one category versus another -- I don't know if 6 it's a lack of transparency if you don't have total 7 consensus. It's just -- it's almost like you sort of have 8 essential tendency in the range of opinion, and you're 9 kind of blurry between two categories. I think in a way 10 that could be transparent and still be ambiguous. 11 But, again, I don't know if we want to get 12 into a long, philosophical discussion on that.

13 DR. WEITZMAN: What I don't see is where 14 the evidence says -- 15 DR. FREY: Oh, absolutely. Yeah.

16 DR. WEITZMAN: -- that. This is a 17 remarkable, advanced --

18 DR. FREY: Yeah. 19 (WHEREIN, unintelligible due to multiple 20 people speaking at once.) 21 DR. WEITZMAN: So simply saying -- because 22 for somebody who's not as (unintelligible) as most of the 23 people on this panel, the transparency statement, the 24 level of detail, suggests that we have nailed which 25 category it is. So one or two sentences, to me, wouldMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 72 1 make us that much more obvious. 2 Plus, I don't interact with industry much, 3 but inconsistencies between one synthesis literature and 4 another opens the door to say that we're -- we don't know 5 if we hit it. To me, the one sentence. 6 DR. FREY: Yeah. Oh, absolutely. 7 Absolutely. So I think we're -- I think we've come close 8 enough on this question that I would like to move on, 9 unless anyone has a burning issue. 10 So I'm going to just take the prerogative 11 of a chair, and let's go through one more charge question 12 before our break. We had a scheduled break right around 13 now, but we're actually -- maybe a while ago. But let's 14 move forward and see if my hypothesis that this was the 15 time consuming charge question and the others will be real 16 quick. Let's see how that works out. 17 So we're next going to talk about Chapter 18 3, and this is on Source to Concentration. And the 19 contributing discussants are Drs. Davidson, Hopke and 20 Mr. Poirot. And the lead discussant is Mr. George Allen. 21 So I'll start with George. Oh, hold on one second. Aaron 22 wants to say something. 23 MR. YEOW: Sorry. This is just a reminder 24 for those on the phone to mute your lines. Thanks. 25 MR. ALLEN: Thank you very much. First ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 73 1 all, I'd like to acknowledge the agency's acceptance of 2 the revision of Chapter 3. It is a clear improvement over 3 the second draft. And I think with some minor changes 4 that we're talking about today that it will be good to go. 5 So I think that's great. 6 The chapter -- changes to the chapter were 7 very responsive to the panel's comments on the second 8 draft. The -- there's a large addition in Section 3.4.1.1 9 on sample collection. It's a good group of description of 10 the state of the science, a measure of altered coarse 11 particles, as I guess they were calling them, greater than 12 ten microns. It fairly illustrated the challenges, the 13 difficulty of trying o measure those larger particles 14 without the biases of the existing high-level FRM that 15 we've all known to -- to have mixed opinions on. 16 And it is understood that the agency will 17 not complete any work on the new, better FRM during the 18 cycle of the lead NAAQS. But I certainly encourage the 19 agency to continue this work as realistically as time 20 allowed. It is a major undertaking, but something that is 21 worth it in the long run. 22 Overall, it seems the readings for 23 non-airport near-source sites, the amount of lead greater 24 than 10 microns is not a lot, 10 to 30 percent, perhaps. 25 A lot of that, you know, being the -- below 15 microns.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 74 1 It's -- in the context of the NAAQS, .15, .21. I'm not 2 quite sure how we ended up ended up with .15 at the old

3 one.

4 These kinds of differences don't have a lot 5 of meaning, certainly in terms of our uncertainty of a

6 link between measure to air -- measure of lead in the air 7 and those to the body. So I don't think -- personally, I 8 don't think we need to worry about the modesty of this. 9 And the effort to validate a sampler of getting EPA sets 10 somewhere up 10 to 20 -- 15 to 20 microns. 11 Anything over 15 gets extremely difficult 12 extremely fast. And I would urge the agency to maybe -- 13 given the limited resources that are currently out there 14 for this thing to work, not to reach too high literally. 15 Maybe try to -- if this panel could support a cut of 15 16 microns -- and I'm not sure we've every really discussed 17 that in this panel from the point of health exposure 18 issues, that I would urge the agency to go with that size 19 cut that is much more practical to achieve both in the 20 wind tunnel testing process and field evaluations.

21 And there is some different -- there's 22 places where different size ranges are mentioned.

23 Sometimes 15 to 20 is mentioned. Sometimes 15 is 24 mentioned throughout the document. So that might be worth 25 the -- pulling those together so that they're moreMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 75 1 consistent. 2 The 3.7.3, the section concludes with a 3 sentence that doesn't seem to be fully supported by the 4 chapter in the Section 3.4.1.1, where it says the existing 5 samplers reasonably capture the airborne fraction of 6 ambient lead that is available for human exposure. 7 That is not necessarily the conclusion I 8 got from reading the Section 3.4.1.1. So there might be 9 some opportunity to clarify that there. I would love to 10 see some of the early general aviation airport lead data. 11 I know a lot of it's out there, but probably a lot of it 12 is not. And I understand that technically the agency has 13 to stick to data that are in AQS and certified. I can 14 fully understand that.

15 But I also know that state and locals out 16 there have a lot of data in the pipeline that are, you 17 know, available if you call them up. And since this is a 18 major issue -- a major undertaking of these 15 general 19 aviation airport that's the pilot. Some of them started 20 late, as this document notes. But a lot of them have

21 collected a fair amount data. 22 So in terms of the goals of that project 23 and that program, it would be nice if maybe the final 24 draft -- or the final version, I should say -- I'm hoping

25 this is the final draft of the ISA that somehow some ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 76 1 those data -- and even if they're preliminary, will be

2 included. That would inform this in terms of -- to an 3 extent these -- not -- you know, these half-ton to one-ton 4 airports could be contributed to elevated lead. 5 Finally, just as a sidebar, in the February 6 issue of Environmental Health Perspectives, there's an 7 interesting article. They call it Sunset for Leaded 8 Av-Gas. It's not a peer reviewed journal article. It's 9 really a news piece. But it does a -- the second half 10 does a very, very good summary of what's currently going 11 on. The process to -- as it says, a push to get the lead 12 out. That's actually in process right now. 13 The time frame, unfortunately, if you leave 14 it to the agencies involved, is more than a decade out.

15 But there's a lot of discussion about how that could be 16 done sooner. So this is something that people in this 17 panel might find interesting. It goes beyond what we're 18 doing right now, but it does give you the good -- the 19 bigger picture of the av-gas lead issue and EPA's efforts 20 to get in the nature of finding, which would move this 21 whole process along and speed it up. 22 And there's a letter from a representative 23 to the FAA saying, you know, let's get the -- get the lead 24 out of your pants and let's move on this one. So that's 25 just a sidebar, but it's the February issue of the EHP asMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 77 1 a news feature if anyone's interested. That's it. 2 DR. FREY: Okay. George, yeah, I want to

3 make a comment before we continue with more discussants. 4 So I think this is a good example of something that -- in 5 some sense, it's actually within our charter to discuss, 6 which would be, for example, the energy implications of 7 implementation of a lead NAAQS. It's actually within our 8 charter to discuss that or provide advice to the

9 administrator. 10 I don't think we're particularly 11 well-positioned to do that in this review cycle. And I 12 think this is an example of something that, as CASAC, we 13 need to establish in cooperation with EPA how to better --

14 fulfill our charter. 15 But just for example, just as a discussion, 16 you know, to the extent that air quality standard might 17 begin to give binding constraint on lead emissions from 18 the airports such to the extent that there is work 19 underway to look for alternative technical solutions that 20 would not substantially reduce the availability of fuel 21 for general aviation, that would potentially be something

22 that we could discuss. 23 I'm not proposing that we do that now, but 24 I just want to point out that this is an example where -- 25 in some ways I think we could be doing more with regard toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 78 1 our charter. And so, you know, I -- I actually supported 2 George in bringing this up. It's -- you know, I think we 3 understand it's probably not something that is actionable 4 in terms of the policy assessment. Maybe it's something 5 that could be mentioned in the ISA, but it is still 6 something that potentially is within our charter. So just

7 an observation. 8 I guess with that I would like to ask

9 Dr. Davidson to offer his comments. 10 DR. DAVIDSON: Thanks a lot, Chris. I just 11 want to echo George's feelings that I think that the EPA 12 has done a great job on improving Chapter 3. I've just 13 got a couple of points that I wanted to make. On Page 366 14 there is a brief discussion comparing the efficiency of 15 different samplers for sampling particles in general. 16 And normally one would expect that if 17 you're going to be comparing two samplers that you would 18 get the best agreement for the smaller particle sizes. 19 And when you go up to the larger particle sizes, you would 20 have a tendency to get a poorer agreement because clearly 21 the efficiency of sampling large particles is more 22 sensitive to the geometry of the -- things like the 23 geometry of the units and the geometry internal to the 24 sampler. 25 But, in fact, there is a comparison thereMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 79 1 between the Texas A&M sampler and the Andersen Impactor 2 where the statement says that for PM 4, you have a major 3 disagreement between the two. But for PM 10, you get 4 reasonable agreement. That's very curious. I'm not sure 5 how that can be the case. So I just want to bring that 6 up. 7 I also want -- I just want to make a point 8 that when we're talking about sampling small particles 9 versus sampling large particles, that in fact one of the 10 -- one of the challenges here is that a lot of human 11 exposure to airborne lead is through the ingestion of 12 deposited airborne lead. For, you know, particularly 13 urban gardens, where people are growing vegetables and so

14 forth. 15 And, therefore, this is a major 16 uncertainty. It's -- I agree completely with George. 17 It's really difficult to sample these large particles, and 18 yet those are the ones that are going to be depositing the 19 quickest onto, say, vegetables that people are growing

20 close to sources. 21 So that is a uncertainty. It's problem, 22 and we really haven't solved that one yet. But those are 23 my two comments. 24 DR. FREY: Okay. I'm just curious -- you 25 know, George raised the issue about the cut size forMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 80 1 samplers, and I think he -- if I understood correctly -- 2 is offering that, in his opinion, 15 microns is a suitable 3 target. I guess to the extent that's something that would 4 get conveyed into a charge question, I think that would 5 merit some discussion from this group of discussants as to 6 whether that is, in fact, something to which the several 7 of you agree and also whether that's something as a panel 8 we would want to support. 9 I don't know -- Cliff, if you have any 10 thoughts on that? 11 DR. DAVIDSON: Well, I think the idea here 12 is, is we have to look at the intended purpose of the 13 sampling, the intended purpose of monitoring. And 14 certainly, George is correct when he says that you get 15 bigger than 15 microns and you start running into 16 inefficiencies in sampling very quickly. 17 I think, though, that it would be -- it's 18 important to be able to understand the exposure of people 19 who are eating vegetables that they're growing near 20 sources and that maybe receiving the brunt of deposition 21 of large particles.

22 And I don't think we have a solution to 23 that problem, you know, short of doing something 24 completely different like having a lead deposition 25 standard or something like that which opens up all kindsMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 81 1 of other problems -- other Pandora's boxes, I guess you 2 could say. 3 But I think the sampling problem does get

4 severe above 15 microns. It's true. 5 DR. FREY: Okay. Let's see, next is 6 Dr. Hopke. 7 DR. HOPKE: Okay. Well, let me -- I mean, 8 I think they've done a real good job of fixing up this 9 chapter. In terms of the sample cut size, I get concerned 10 on focusing on the smaller particles because we do have 11 nasal deposition. We have kids running around where 12 they're going to go into oral breathing. And so there's 13 going to be more inhalability than we normally think 14 about. And particularly the stuff in nasal deposition

15 where it then moves back into the GI tract with the

16 transfer of mucus. 17 So that, you know, having spent the last 18 several years working a lot on Chrome 6 sampling, where we 19 have the same basic issue, I'm worried about the transfer 20 through the GI tract. Unless we can come up with some 21 cleaner, better relationships between large particle 22 distributions and, you know, this -- the shape of coarse 23 mode so that we know that IP 15 really represents X 24 fraction of the coarse mode, I think it's problematic in a 25 broader CS mode to some of these low-volume TXP heads,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 82 1 like the one McKinney came up with or something like that 2 where we have a reasonable -- you know, we no longer at 3 least have the wind speed and direction issues. We still 4 have, you know, a cut point that's obviously cutting the 5 whole portion of where we cut. 6 Again, keep in mind that we measure PM 10 7 and PM 2.5 mass reproducibly wrong by regulatory processes 8 so that, you know, we need to, to work at something which 9 gives us a useful measure of a sufficient fracture of the 10 exposure that we really get a good estimate of what's 11 going on. 12 I mean, the big particles are going to be 13 largely still around the point sources and are not going 14 to be transferred probably very far. So, you know, one of 15 the big questions still is, are we adequately using 16 Section 109 kinds of controls that are in those point 17 sources and not treating -- and maybe we should be 18 treating these much more as hazardous air pollutants than 19 criteria air pollutants, but that's another discussion. 20 But there are, you know, multiple tools 21 that the EPA has to try to reduce that exposure in those 22 areas. And there probably needs to be a more deep code of 23 attack. I mean, in terms of the general exposure, you 24 know, you'll see the big targets have the av-gas. I mean, 25 if we can do that, then we can reduce substantially theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 83 1 general population exposure. And other than that -- you 2 know, odds and ends (unintelligible). 3 DR. FREY: Okay. All right. Well, let's 4 see, let's go to Rich and see if we can just synthesize 5 what our message is. 6 DR. POIROT: So I agree with the previous 7 comments. I think some of George's points were right on. 8 You know, the agency was really responsive to our comments

9 last time. It reminds me to be careful what to ask for 10 because they really did everything, I think, that we asked 11 other than this chapter, particularly. 12 But I thought one of the most important

13 additions that reflects on that last discussion that was 14 starting up was, in addition to the section on alternative 15 sampling methods by collecting larger particle sizes, 16 there was a couple of really important, I thought, 17 including statements on various -- Page 368, specifically 18 that the relevant particle size distribution from ambient 19 sampling is smaller than the size distribution for sampled 20 dust, particles selected have been about -- 20 microns are 21 considered too large to be transported by more than a few 22 seconds under typical conditions. 23 To me that's a really important distinction 24 to make; that granted the ingestion of lead includes a lot 25 of larger particles incorporated in dust and taken up byMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 84 1 hand to the mouth and so on and so forth. That absolutely 2 doesn't necessarily mean that that's how we decide what 3 size -- particle size distribution is appropriate for 4 sampling lead concentrations in the ambient air. 5 To me that's a really important addition 6 and concept to carry forward. And it seems to me this 7 idea that particles larger than about 20 really don't have 8 much of an atmospheric lifeline. You know, they are part 9 of this so-called photo suspended particle thing, but only

10 for a few seconds. 11 A representative, either in space or in 12 time, is a sample that's collecting particles that are 13 under microns in diameter, depending on the speed and the

14 direction of the wind and so on and so forth. So to me 15 that's a big deal, and it suggests that there's this 16 convergence between what's feasible, a collection of 17 particles up to a certain size point, and what's 18 desirable. And that's, I thought, dependent on what 19 points directly (unintelligible).

20 It leads me also to make another 21 observation. I -- you know, here and there in this 22 chapter, and I know it comes up in other chapters where 23 the methods are more thoroughly understood, but this 24 concept of dust and loading, which I assume has units of 25 micrograms per square meter and loading rates ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 85 1 (unintelligible) and so on of dust. Well, okay, so how is

2 the dust measured? 3 You know, I know we see a late sample on a 4 hard surface, but then they're talking about dust loading 5 rates at urban streets and to sidewalks. How do you 6 sample that to loading and determine that loading? How do 7 you measure it? And what are its particle size

8 characteristics? 9 Because almost certainly there's this

10 transferal over the time from the emission of lots of 11 small particle lead that's incorporated into larger 12 particles, either in the atmosphere or shortly following 13 deposition, and then gets incorporated into this dust 14 which is available for ingestion in which falls especially 15 on -- regarding plants and that sort of thing. 16 Is it necessarily the same ambient air lead 17 that we're talking about. So a little more information on 18 dust, how it's sampled and what is the particle size

19 characteristics involved would be useful. 20 Just a few other minor points. I -- you 21 know, maybe this is picky, but the term "TSP," you know, 22 we all use it to mean, I think, whatever we want it to 23 mean. It's become so imprecise that it means on one hand 24 orbital suspended particles. A hypothetical concept it's 25 impossible to measure, but it -- as it's used for leadMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 86 1 sampling, what we really mean is TSP -- whatever the 2 high-volume sample it collects, that's what we're defining 3 as TSP in that sense. When we talk about TSP lead, what 4 we mean is lead likely by the hi-vol. 5 But we also use TSP in the same chapter 6 where a number of other samplers have been called by their 7 inventors TSP samplers. But what they collect is not the 8 same as what the hi-vol collects or what any other 9 so-called TSP sampling collects. And we also talk about 10 the future alternative yet to be developed TSP sampler.

11 Those are four different uses of the same term. 12 How are we ever going to get precise in our 13 measurements if we can't be more precise in our language. 14 So just -- and maybe it's minor. Maybe we've been doing 15 this for so long that we're comfortable with it. Yet it 16 just hit me that, Let's be a little more precise if we

17 can. 18 Again, if you're talking about so-called 19 TSP, meaning something different from what's hi-vol to us 20 and not in quotes -- what was the term I was thinking of, 21 you know, particles larger than ten is what we really 22 mean, PLT. Something bigger than ten, we don't know what

23 it is. We don't know how much. That's what we mean. 24 Let's call it that rather than pretending that we're 25 talking about the same thing.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 87 1 The last maybe minor comment I have was I 2 just happened to notice there was this nice bigger 325 on 3 Page 3-107 that's the correlation of lead with all of the 4 other line particles species measured in the CSM network. 5 And it just shows -- it ranks them from best correlated to 6 recent and so forth. And I just noticed that it's 7 different from the same exact figure presented in the 8 previous bracket. The things are in different orders.

9 The elements are in different orders. 10 And I'm just curious as to how that came 11 about. One of the reasons being that on the previous 12 version, potassium had had the second highest correlation 13 with lead of any other -- of any other species behind 14 zinc. And now the passing was bumped down three or four 15 notches, something like that. I think it's in eighth 16 place. 17 And then I noticed in the appendix you've 18 got the seasonal correlation, the same pictures are done 19 by spring, winter, summer, fall. And potassium comes in 20 second, third, fourth and second. And yet it comes in 21 eighth place in the annual -- and, you know, it has the 22 implication we've now have available from all this 23 receptive modeling work. Potassium is a great wood smoke 24 indicator, but it could also be fireworks. 25 There's an interesting thing, I just cameMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 88 1 across it last night, I'll put it in my advice comments. 2 But paper -- a card research study that showed extremely 3 elevated lead during a fireworks event. And not only 4 that, but the lead had an Asian -- a Chinese 5 (unintelligible) signature and so forth. 6 Anyway, it's just a minor point. That's 7 all I have to say. 8 DR. FREY: Okay. Well, I think both you 9 and Phil kind of allude to that -- this is my 10 interpretation -- it was about the particle measurement 11 techniques. They're really operational definitions of 12 what is a particle and what is a component of a particle. 13 So it's not a philosophical definition. It's a definition

14 of what can be measured. 15 And even a PLT that you propose -- it's 16 probably particles less than ten, but it's actually some 17 fractional cut point that it -- some could be bigger, and 18 so it's -- it's an operational definition. But I guess 19 that's the reality that we have to live with. But John 20 Vandenberg, if you want to clarify. 21 DR. VANDENBERG: Well, just to -- 22 specifically that question -- and I don't know, Jennifer, 23 do you want to just share with -- why that would be the 24 change? And while she comes up, I might note that when I 25 was at the commission meeting last week, there was a lotMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 89 1 of discussion on wood smoke and markers in the atmosphere. 2 Particularly in Greece, where evidently -- 3 because of the extreme poverty there, they're burning 4 furniture. They're burning their furniture because they 5 have no other source of heat. So they're getting a wood

6 smoke mixed with metals. 7 MS. RICHMOND-BRYANT: Just quickly, the 8 reason for that change in particular was, as we've 9 responded to the comments from the last time about using 10 this Pearson versus Spearman coefficients, it changed some 11 co-relations. And that was when that switched gears. And 12 we're hoping that the consistency in seasonal loads was 13 because it may have convinced me to present all of the 14 Spearman coefficients that would be amongst those data. 15 So that was the reason why. 16 DR. FREY: All right. So I guess to 17 summarize, it seems like it's fair to say that the three 18 or maybe all four of the discussants on this topic are 19 kind of converging toward the practicality of something 20 with like a 15 micron cut point; that that -- as Rich 21 pointed out, that particles larger than 20 don't transport 22 very far. And maybe even the 15 to 20 range they don't 23 transport very far.

24 So in terms of like an area-wide ambient 25 indicator, you know, something up to 15-ish is probablyMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 90 1 not too bad. But on the other hand, there is a source 2 unit total particle signal, which I think as Phil alluded 3 to, either might be represented with a different kind of 4 TSP sampler. And as Cliff pointed out, we probably don't 5 want to move into a deposition-base method. 6 Is that a fair summary? 7 DR. HOPKE: I think we're underestimating 8 the transport here. I mean, a 15 micron particle has a 9 deposition velocity of 7 and a half, 7 meters per second. 10 And, you know, at some wind speeds (unintelligible) and 11 carry it. I mean, you know, 20 to 30 micron particles, 12 they're going to have lifetimes of the ordinary of a few 13 hours. That's certainly enough to cover much of the urban

14 area. 15 And a 10 micron particle has a lifetime of

16 about 24 hours.

17 DR. FREY: So what's the --

18 DR. HOPKE: I think we have to be careful 19 here of not -- of recognizing the transport if -- you 20 know, these aren't baseballs that we've got. 21 DR. FREY: Right. So do you see a role, 22 then, for a combination of a -- well, sort of a coarse of 23 an endpoint -- 24 DR. HOPKE: There's a good understanding of 25 the fraction of the coarse mode that's PM and a high beMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 91 1 15. But, you know, it's pretty variable depending on what 2 the sources are. And, you know, again, a few big 3 particles carry a lot of mass. It would probably be a 4 good particle size. And so I just worry about whether 5 they're estimating the exposure in areas where there could 6 be large particles in a way that then would give us a 7 problem in producing more exposure than we think there is. 8 And this is an area -- you know, we'd really like to solve 9 this problem once and for all. 10 MR. ALLEN: Well, are you suggesting that 11 we goes as high as we can and take the time and effort to 12 suggest to the agency to push it as much as they can,

13 which will still be well under 20 microns? 14 DR. HOPKE: Right. And the point is, there 15 are other things out there in the NAAQS network that also 16 come into this play in the same similar way. So, you 17 know, I have to think there could be multiple benefits 18 beyond the lead issue if we had a sampler that would agree 19 on this more reliable, in terms of providing that 20 information -- a more inhalable -- not ingestible, but 21 inhalable that would include things that, you know -- 22 again, not -- wouldn't get into the respiratory tract, but 23 it would get into, you know, nasal deposition and into the

24 GI tract. 25 DR. FREY: Okay. So --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 92 1 DR. DAVIDSON: Chris, I was just going to 2 give input on that. To build on what Phil just said, that 3 I think there's one -- there's an important message here, 4 which is that the exposure to population is not entirely 5 small particles, even though those are the easiest ones to

6 measure. And so I think that the document needs to make a 7 point that there can be exposure to larger particles, but 8 that right now they can't be measured very well and that

9 this is a weakness that we have. 10 DR. FREY: Right. Yeah, exactly. Rich. 11 DR. POIROT: Well, I just wanted to maybe 12 point out the obvious that all of these sampling designs 13 using size selective inlets and filtration techniques, you 14 know, can be characterized in a number of ways. And we 15 tend to think of a 50 percent cut point. You know, we'll 16 let in half the particles of this size as being sort of 17 definitive. But at the same time, they're letting in 40 18 percent of the particles that are a little bigger than 19 that and 20 percent and so on. 20 So they all have these slopes to the cut 21 size, which may actually be at very realistic in terms of 22 the overall exposure regime and the importance of smaller 23 versus larger particles, I think, in that sense as well. 24 So it -- you know, and a counterpoint to

25 that is that from the discussion that we heard last timeMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 93 1 from Bob Vanderpool, that -- you know, that there's a 2 potential that a sampler with a somewhat higher cut size 3 in the range of 15 could actually collect more lead than a 4 TSP sampler does under certain conditions because it's 5 imperfect and its collection efficiency of all of these 6 particles in different size ranges as well. So it may 7 very well be -- especially if the lead tends to be in the 8 less than 20 micron size range, that kind of an approach 9 may actually collect more lead than the hi-vol TSP's

10 and --

11 MR. ALLEN: I think we've started 12 struggling with facts versus ideal solutions to this 13 problem. And as Rich implied, whatever EPA comes up with, 14 we'll probably have a rather sloppy size cut, which is 15 actually okay. Typically for a PM 2.5 we want to be as 16 sharp as we can. For the TSP, we don't care if it's at a 17 rather broad cut as long as it's reproducible in terms of

18 a measurement that it does. 19 We're not going to get a sharp cut, I know 20 that much for sure right now. And that's okay. You know, 21 I'm trying to just kind of ground things in reality as to 22 what is possible within the reasonable amount of effort. 23 We know we're never going to be able to render near 24 sources. Well, if you want to measure near source, 25 everything you do puts out a dust bucket. But we don'tMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 94 1 want to go there, I don't think, certainly not as a 2 (unintelligible). 3 DR. FREY: Okay. I think we've probably 4 reached closure on this. And so, George, your homework is 5 to draft a draft response to the charge question with 6 input from your fellow discussants. Are there any other 7 members of the panel that would like to weigh in on this? 8 Okay. Yes, Herb. 9 DR. ALLEN: Just one comment. Every time I 10 hear things and read things in here, I note that there are 11 issues brought up in one chapter that have great 12 application to another chapter. And there often not

13 indicated within the document itself. One that is in 14 Chapter 7, it is seemingly interesting is the honeybees 15 collected near an airport had the highest concentration of 16 lead out of the study. So that sort of says something

17 about aviation. 18 DR. FREY: Okay. 19 DR. ALLEN: So to add to the samplers.

20 Now --

21 DR. FREY: Yes. Yes. 22 UNIDENTIFIED SPEAKER: Mosquitoes too. 23 DR. FREY: Oh, yeah. They just need to 24 come up with an acronym for that. Yes. 25 DR. RABINOWITZ: Let me just quickly ask --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 95 1 maybe I'll learn something. The question of particle size 2 collectors, is this area more developed than the studies 3 for occupational exposure? 4 MR. ALLEN: No. It's the same problem. 5 DR. RABINOWITZ: The same problem there. 6 Okay. Thank you. 7 MR. ALLEN: Most occupational exposures, 8 the cuts and its use -- that's just what they've done -- 9 deemed important from an occupation perspective, which is 10 different than the larger steel immediate exposure, of

11 course. 12 DR. FREY: Okay. I think we need a break. 13 So during the break, you know, get psyched for quickly 14 responding to charge questions. We'll go ahead and break 15 until 11:05, and we will start promptly at 11:05. 16 (WHEREIN, a brief recess was taken from 17 10:52 a.m. to 11:05 a.m.) 18 DR. FREY: Okay. Our next item of 19 discussion is on the ISA charge question related to 20 Chapter 4, which is on Exposure, Toxicokinetics and

21 Biomarkers. And the discussants are Drs. Pounds and 22 von Lindern, and the lead discussant is Dr. Hays. So I'm 23 looking for Dr. Hays. There he is. Okay. So the floor 24 is yours. 25 DR. HAYS: Thank you. I'd like to commendMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 96 1 the EPA on a good job on Chapter 4. The section on lead 2 in consumer products is not such a great addition. It's 3 extremely helpful, but of course wasn't very helpful. 4 However, the discussion of the importance 5 of the lead in consumer products is extremely sparse and 6 seems to have (unintelligible). I don't know how many

7 studies have been done to show how lead in consumer 8 products can impact what that does. Maybe there are none 9 and that's why it's based on that category. Because given 10 some of those levels, it seems like some of the consumer 11 products that are out there could have significant impact 12 to (unintelligible). 13 Obviously, the -- the assessment for the 14 NAAQS is based on relationship between lead and air 15 ambient levels. And I thought the discussion of those 16 studies that are available in the current relationships 17 and the historical perspectives around the declines in the 18 use of lead in gasoline and related decreases in blood 19 lead in the U.S. and other countries is helpful, 20 especially for establishing the context around setting a 21 lead NAAQS. 22 However, the description of the empirical 23 models and the strengths and weaknesses that are available 24 was good, but what you find is that -- I'm looking through

25 the studies that have been done in the associated smelterMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 97 1 or mining communities, which are very different than the 2 scenarios than what's going on with the general population 3 and setting a NAAQS. 4 Furthermore, it's a challenge about how our 5 blood in relationship is (unintelligible) and excluded at

6 the blood lead levels. Most of the studies have blood 7 lead levels that exceed ten. Some, you know, are as low 8 as two, but that was the minimum in that study. Some of

9 the areas in the -- none of the studies that we have 10 available for the air lead have captured what's really 11 going on in the environment today in the U.S. for air 12 concentrations and very low blood lead levels. 13 It's a very challenging perspective. It's 14 not clear the NAAQS below .15 will have any impact on that

15 method. 16 MR. MCNAMARA: I'm sorry. Move closer to 17 the mic, please. 18 DR. HAYS: Okay. Sorry. Having a

19 statement like that is sometimes conclusive like that in 20 the ISA and may be helpful as well. That sentiment was 21 not captured in the ISA, but I think it was captured in 22 the policy assessment. 23 The relationship between blood and air in 24 Figures 4-22 and 4-24 seems to implies that the blood lead

25 level declines at 0.0 there at lead levels. That's notMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 98 1 the case, it doesn't seem. And I don't think they realize 2 that it's important to have a range there. So consider 3 complicating the figures of this levels that are supported 4 by the ambient is (unintelligible). 5 I'm not sure that the data that they've 6 attached suggests that we take the air lead levels to 7 zero. What I would love to see is something like a pie

8 chart that shows me how we could collect the lead from 9 various sources. That's a function that would work very 10 well. That really has not been captured in this 11 discussion. I mean, I don't think it's just generally the 12 community in relation about air, the relationship about

13 air. 14 So I think, you know, this integrated 15 science assessment is good, but it's really not -- to be 16 honest with you (unintelligible). Do you want to comment

17 on that? 18 DR. VANDENBERG: Just that we appreciate 19 and consider your comments. And we couldn't find the data 20 to do that and didn't feel like we should recycle that 21 whole section. I appreciate that. 22 MR. BROWN: I would just say that it would 23 be very situation specific. 24 DR. HAYS: Absolutely. I totally agree. 25 Yeah. And maybe some communities where it doesn't pointMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 99 1 to sources of lead that they would have a higher level. 2 We need other communities where you've got normal 3 exposures, you have some high blood lead levels associated 4 (unintelligible). That kind of discussion would be 5 helpful. And I agree, we probably won't be able to visit 6 that. To me it would be useful to have that stipulation,

7 but... 8 Now, beyond that, I have some specific 9 editorial comments, which I won't go into at this time. 10 DR. FREY: Thanks, Sean. Dr. Pounds. 11 DR. POUNDS: I really like clarity of this 12 chapter. I'm particularly pleased by the lucid 13 description of the topic strengths and limitations 14 introductory found in many of the introductory and 15 concluding sections. 16 I kind of made just, you know, three 17 comments to kind of give my colleagues a chance to reply. 18 Not necessarily in particular order, I agree. Table 4.9, 19 that describes the XRF measurements to population studies. 20 There's part of the text that's already notes some of the 21 issues relating to the measurements and interpretation of 22 this data, but the table doesn't indicate how they

23 censored the data. 24 In order for the panel to draw conclusions 25 about the distribution of all lead in the separate studiedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 100 1 populations, we really need to do that. You can't get 2 there just as a standard deviation. It lets you know how 3 the authors handled missing data. Sometimes it's not a 4 problem if the data is expressed in subtitles. Mostly 5 it's just (unintelligible). I think you can get that out

6 of the literature for most of the studies. 7 Secondly, it's a suggestion. So maybe if 8 the plots that were done with the later model that show 9 timed appendix decreases the blood lead levels, especially 10 after sensation of lead inputs in the models, our -- 11 especially because they compress and could be different 12 many years, even a lifetime (unintelligible). 13 And that time compression supports the 14 conclusion for it to decrease blood lead levels is very 15 graphic, which is at odds to what epidemiologist and 16 occupation health physicians expect when they are 17 typically following blood lead levels over periods of a 18 few months or a couple years. 19 So I suggest that this potential confusion 20 could be alleviated by just spinning on that curve after

21 removal of lead from all two and three terms. Some of 22 that is (unintelligible) in calculating the half-times of 23 those three compartments. 24 And then, again, I should note that those

25 calculated half-times would be consistent with the kindsMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 101 1 of data that the reported literature, at least from 2 occupation, cites. You could alternatively show an 3 additional plot that would show us just that timeframe 4 expanded to show the plot. 5 One other comment. Chris is suggesting 6 that it's okay to suggest recently, you might consider 7 speculating, because I'm not aware of it directly, the 8 potential role of a human microbiome in modulating lead 9 bioassessibility of lead. There are many reports of 10 literature optimizing or reducing reverse 11 (unintelligible). 12 And so, you know, I'm plausible that 13 depending on the (unintelligible), which is the kind 14 that's on age, gender, diet and so forth, that there could 15 be a contribution to these dissolution, changing of 16 access, if you will, to different level of minerals that 17 could be said to be sound to be incorporated. 18 That's the big -- I think that's just a 19 research and not something -- I think it's something to 20 do. I think all the other comments are self-explanatory. 21 DR. FREY: Okay. Thank you.

22 Dr. von Lindern.

23 DR. VON LINDERN: Thanks. This time I can 24 concur with my colleagues. They have great comments. 25 They've took most of mine. Especially with regard toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 102 1 Sean's, and I think it relates to Michael's earlier

2 comment as we're headed into much lower blood lead levels 3 and much lower exposure. The slope and relationship, it's 4 probably changing remarkably and it's going to be hard to 5 keep up. But practically we probably know what we need to

6 move forward.

7 There is a wealth of blood lead level 8 information, and health information that continues to 9 accumulate. Relative to the past, there's a lot less 10 exposure information available across the country right 11 now. And this is, perhaps, one time that I won't chastise 12 the agency for not providing that data. Instead, I 13 really, you know, question myself as to how critical that 14 is in terms of the other places where resources could be 15 expended on, on health issues. 16 So maybe that's a point in which we're good 17 enough for a while. I think in terms of presenting this 18 information that you did an excellent job. And this 19 chapter has improved remarkably through the drafts, I 20 think. And it does a good job now discussing the 21 uncertainties while reaching the important conclusions 22 that are necessary to support the use of the document down 23 the line. So that's my comments on this. 24 DR. FREY: Do other members of the panel

25 have comments?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 103 1 DR. KOSNETT: I was pleased that -- related 2 to other editions, I like the particular -- the fact that 3 on the modeling you included the rate of change to the 4 higher exposure and the sort of effect. And you didn't -- 5 you know, the first document had a sentence that said, 6 Well, after chronic exposure, when you reach some exposure 7 of blood lead levels to where they were before. And then 8 you gave a scenario (unintelligible). 9 So now you illustrate that when you have 10 higher levels of exposure, you build bone up. I think 11 it's a nice -- thank you for doing that. 12 The other thing I briefly wanted to say, 13 you know, the -- one of the key things that comes out of 14 this chapter is the relationship between air lead to blood 15 lead level relationships, right? Because, ultimately, 16 when you set a standard, you must apply air lead to blood 17 lead and blood lead to IQ when you make a decision. 18 So they have -- you know, I don't -- the 19 table, 4-12, that summarizes the study. They have a 20 paragraph on Page 4-144 that talks about, well, the slopes 21 are ranging (unintelligible). 22 But it doesn't really -- in this document, 23 it doesn't really make a final analysis about which ones 24 are the best for this assessment. To the extent, for 25 example, that a policy assessment looks at it and says,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 104 1 Well, we're going to take a median of 1 point -- a set 2 (unintelligible). 3 Did you want to not really weigh in on what 4 you think is the best for this document and kind of let 5 the folks who did the policy assessment and make that

6 call? 7 DR. VANDENBERG: We typically lay out the 8 evidence here, the judgments that listed -- included in 9 the list of descriptions. That's typically how title

10 that. And I know that some of the comments on other 11 ISA's, including this one, has been an encouragement for 12 us to move more into, given the range of data, what would 13 be the preferred approach. You know, we found that to a 14 greater or lesser extent. 15 DR. KOSNETT: Okay. I -- and I -- that's 16 fine. I understand. I'm just saying some people will not 17 find the policy assessment -- this is a bible of the 18 future. And so people are going to be turning to this 19 and, you know, it might be nice -- because this is such an

20 incredible document -- to include more of that discussion. 21 But you do kind of give an average change in the tables 22 and at least in the slopes. 23 This is kind of -- you know, like kind of 24 pointing people to this agency language. But it -- no big 25 deal, but I'm just -- they haven't really -- they laid itMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 105 1 all out on the table, but they don't always say 2 (unintelligible). That's done in the policy assessment. 3 If you felt compelled -- if you felt inclined to maybe 4 reiterate what you said in the policy assessment, then you 5 could -- but you don't have to. 6 DR. FREY: I think I just want to see if 7 Phil Goodrum is on the phone. And if so, if he wanted to

8 offer comments. Phil? 9 (No response.) 10 DR. FREY: No. Okay. Any other panelist 11 want to weigh in on Chapter 4? Sean, do you feel like you 12 have what you need for drafting your charge question? 13 MR. HAYS: (Nodded head.) 14 DR. FREY: Okay. Thank you. Okay. 15 Excellent. Well, in that case, let's move on to Chapter 16 5, which it will only take a few minutes, right. And the 17 lead discussant on this is Susan Korrick, and the other 18 discussants are Richard Canfield and Michael Kosnett. So, 19 Susan, the floor is yours. 20 DR. KORRICK: Okay. Thank you. First, I 21 have to commend the agency for doing an incredible job of 22 trying to address a lot of very complicated issues. I 23 think that this draft is a big improvement over the 24 previous ones. 25 In particular, I think the most fundamentalMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 106 1 concern we had previously was that the causal assessments 2 were not as transparent as they should be. And 3 particularly that the data measured would be in the 4 literature that was carefully acknowledging the issues and 5 strengths was not as explicit as it should have been. And 6 I think that this version addresses those issues, for the 7 most part, quite nicely. 8 Which takes me to some of my specific 9 comments. Which I think that the piece that's still 10 potentially debatable, I think, is that we're finding it's

11 not critical. And that is the kinds of issues that came 12 up and we talked about, the preamble and in Chapters 1 and 13 2, where -- in cases where the strength or evidence is not 14 clearly causal between lead and some particular health 15 outcome, distinguishing between likely causal and 16 suggested is a very subtle nuance distinction.

17 And it's hard to tell from the document how 18 those -- how decisions are being made, distinguishing 19 between those two categories. I'm not sure that that's 20 critical. I think the point is that we could all put 21 differences of opinion in that gray zone. And as long as 22 the criteria and the information that's being looked at 23 for each particular category and how that is very 24 explicitly defined. The ultimate choice in that gray zone 25 is probably not as critical.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 107 1 And so I think that you guys did a very 2 good job of that. So I think there's going to be debate 3 among all of us as to whether or not something falls 4 within that gray zone, but that's not the key piece. The 5 key piece is providing the information that got put into 6 the gray zone to begin with.

7 So I think that another area that we talked 8 a lot about last time was the notion of trying to divide 9 -- or identify health outcomes in more specific groups 10 that have some functional formalities as well as allowing 11 the risk of the system, but the causality system to be

12 more focused. 13 And I think you did a really good job of 14 that, for the most part. I think what -- again, it's sort 15 of reached a point in my mind that the -- some of the

16 issues with the document are more subtleties about how 17 those groupings remain, and there may be some debate about 18 whether they were all -- what everyone would agree with.

19 I know Dr. Canfield had some comments around that that

20 I'll let him add. 21 And I think that -- you know, in some cases 22 the choice of groupings was not what I would have chosen 23 and some groups of studies were not necessarily organized 24 in a way that I would have chosen, but I don't think

25 that's at issue.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 108 1 And I have some specific comments around 2 that. For example, you know, under school achievement, 3 the WRAML verbal learning task was listed and that has 4 nothing to do with school achievement. So there's some 5 organizational issues that are not quite accurate, but I 6 think those are really not important into the big picture. 7 Let me just see here. Another sort of 8 larger issue, and I'd be interested to hear what other 9 folks think, is that -- especially for the nervous system 10 studies which is by far the most extensive portion of 11 Chapter 5, the text indicates that some of these are 12 organized according to strength of study design.

13 So there's a clear distinction between 14 prospective and cross-sectional studies. But then within 15 those groupings, it's actually hard to know what the 16 specific design issues that were used to prioritize were. 17 And it's not immediate point, but it sort of gives out 18 this issue of how you think about ray zones. Like if you 19 -- depending on what component, I'll say design is 20 important to me (unintelligible) way of particular 21 findings. And it's a little hard to tell from the text or 22 the description how that was done. 23 You know, for example, on the adult 24 cognition studies, the Baltimore Memory Study is very 25 prominently featured as a prospective population basedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 109 1 study, and it's a good study. But there's some other 2 analysis that weren't ingested or compounded by smoking 3 and alcohol which I think is a potentially important 4 weakness, and it's not really discussed. 5 And maybe the rationale is that it's 6 sensitive to the over-adjustment, but some acknowledgement 7 of the complexities was missing. And I'm not necessarily 8 advocating that the document do that because I think it's 9 already several hundred pages, this particular topic, and 10 you could spend the rest of your lives with this. But

11 there are some subtle issues that are kind of hard to 12 piece out. 13 I think the other subtle issue I just -- I 14 think is worth mentioning is that there's a lot of 15 emphasis in the document in assessing study quality on 16 what's called representiveness. And I assume by that they 17 all mean generalizability. And I think that in a lot of 18 cases it's all misplaced emphasis. I feel as if some 19 studies are downgraded -- for example, the Cleveland 20 cohort in kids were effects of lead on -- only two were 21 not consistently seen. 22 It's, I think, downgraded. And it's 23 important, in part, because the population was felt to be 24 not representative of the generally most population 25 because of the high problems of alcohol and substanceMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 110 1 abuse during pregnancy. 2 And I think that -- there's two issues, I 3 guess. One is more of a -- I don't know if policy is the 4 right word, but obviously you want one or two that's 5 applicable to the generally most population because that's 6 the group that's of interest in terms of the policy that

7 will result from the science.

8 But I think the other issue is whether 9 representativeness or generalizability affects validity. 10 And they're not, in my mind, is not the -- they're not the 11 same. If something's not generalized, it doesn't 12 necessarily undermine. It's the written data. 13 So the fact that there was a high 14 prevalence of alcohol use during pregnancy and that cohort 15 doesn't necessarily mean that their findings are not

16 valid. And if it turned out that the effect of lead in 17 the context of prenatal alcohol exposure is different, 18 then in the context where prenatal alcohol exposure has 19 not occurred. That would affect the validity in some 20 study and how we really looked at the specific event. But 21 that's not how it's presented in the document. 22 So I think some things are -- the role of 23 representativeness, to me, is a little overemphasized and

24 is sometimes -- I think -- I'm sure it could be used to 25 undervalue studies that don't always find what theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 111 1 majority of the studies find. And I think that -- that's 2 just a caveat to keep in mind in sort of summarizing the

3 literature. 4 And then I -- again, this is a fairly 5 specific comment. But I think in an effort to provide 6 very specific health outcome categories, that was 7 generally done extremely well and was very helpful in all

8 senses. Both in terms of the robustness of the literature 9 summary, but also robustness of the causal assessments.

10 But sometimes the document reversed back to 11 more generalized statements, and we'll talk about 12 conclusions around, say, sensory effects of lead. Where I 13 think the sensory effects are quite different and we will 14 be hearing your decision. And the nice review that 15 depicts those different sensory components and listed 16 consecutively gets lost since the summary ends up combined

17 at the end. 18 So I would just urge you not to lose track 19 of the hearing advice and the more (unintelligible) that 20 you take and we'll make summary statements where you don't 21 list the benefit of that more specific analysis. 22 I guess the other thing -- one of the other 23 charge items is the extent to which the nervous system 24 outcomes have been grouped into appropriate constructs and 25 the appropriate parallels were drawn between endpoints ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 112 1 humans and animals. And I think that this also has the 2 proof, I think, that paring the text to the toxicology 3 summaries that deal more directly with a particular health 4 outcome that's been analyzed in epidemiology, that paring 5 them together so that they come in sequence is helpful 6 just in terms of being able to integrate those two

7 literature streams. 8 So I think I'll stop there because I'm sure 9 my other people have a lot to add. But, again, I think 10 it's much improved. And I think that this gray zone on 11 causality is going to be an area that we're going to have 12 to agree to disagree on in some cases. 13 DR. FREY: Okay. Thank you, Dr. Korrick.

14 Dr. Canfield. 15 DR. CANFIELD: Yes. Thank you for that

16 nice overview. So I would start with what I think is the 17 main issue that I have, and I'm going to say a couple of 18 words and I'm going to throw it to Gail and see if she 19 just wants to do my work for me. 20 And that is this grouping of -- we've got 21 these internalizing behaviors in a few places, but you 22 don't really take advantage of the grouping and the 23 effects of internalizing. And you're lumping attention 24 and attention-related behavior problems. And, again, what 25 we're asking you to do is clean nature at its joints in aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 113 1 way that probably not everyone agrees, but where the 2 joints are. So I'll give you that, and this may be good 3 enough. 4 But maybe, Gail, are you -- would you be 5 interested in talking about the internalized and 6 externalizing? I would say one possibility to consider is 7 to take internalizing, externalizing and attention. And 8 -- but Gail is more qualified. Is that something you 9 could help us with? 10 DR. WASSERMAN: Do you want me to talk now? 11 DR. CANFIELD: Yes. If you're -- if you're 12 -- if you would like, please.

13 DR. WASSERMAN: In terms of children 14 behavior problems, you do have two big clusters. You've 15 got internalizing problems and externalizing problems. 16 Mind you, they are highly correlated. And that -- that's

17 one concern I have in this section. And that doesn't -- 18 we're not really talking about necessarily independent 19 outcomes. It's almost as though they give you an IQ, and 20 so are performance and durable aspects or executive 21 function and IQ. It's not like this is iterated. 22 It may be all the same problems we're 23 talking about, like having different outcomes from the 24 core. So that should be mentioned. But if you take the 25 big chunks in internalizing or externalizing, that wouldMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 114 1 probably be the most (unintelligible) way to begin. And 2 that would put the extension problems in with the 3 externalizing where there's disagreement about that. 4 But simplest cutting of the wire, 5 internalizing on the line in and externalizing on the 6 other end. So within that issue, internalizing problems 7 would be things like anxiety. It would be things like 8 learning problems. 9 Mind you, there's another whole layer that 10 has to go on top of this, which is that there's a 11 difference between problems or symptoms or items on a 12 checklist which are generally looked at continuously and 13 more categorical diagnostic features. 14 So there's like two big things that are 15 like overlaying each other. But within the internalized, 16 if you could look at, you internalize and take your 17 problems and each construct has its how to part in the 18 diagnostic makeup as well as an incentive makeup. 19 And there are probably -- I agree. I got a 20 little confused with the conduct problems and 21 externalizing them separately because I would put the 22 conduct in the externalizing. As a subcategory I would 23 put the attention problems in with the externalizing as a 24 subcategory. And that might make things go a little bit 25 more smoothly. But they are intercorrelated probably onMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 115 1 any attempt we you make. 2 DR. CANFIELD: So, I mean, what I was 3 struggling with is whether I could justify asking them to 4 seriously consider using externalizing and internalizing,

5 whether that would make life easier and this more readable 6 and we'd have a sudden exit of personnel from EPA. 7 DR. WASSERMAN: I think the text -- you 8 know, have a big group for internalizing. And within that 9 have all of the things, the diagnostic and the symptom 10 things as separate subcategories. And then that would 11 move the conduct problems as a subcategory of the 12 externalizing. 13 DR. CANFIELD: I included in my comments a 14 group reg. So at this point, maybe we can talk over lunch 15 or something about -- or at some point of what you think 16 of that, of you can give some feedback now. I don't know

17 if that's a -- 18 DR. FREY: Well, yeah, procedurally we have 19 to deliberate in public on any advice that we would put in 20 the charge question or the letter, so -- and we can 21 provide advice whether or not EPA wants the advice.

22 That's another dimension. 23 DR. CANFIELD: Okay. Well, that's my call 24 then. Okay. 25 DR. FREY: But I guess to the extent ifMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 116 1 Dr. Vandenberg or others want to give us a little 2 perspective on how they receive this, we can do that now. 3 DR. VANDENBERG: Sure, if I might. So, you 4 know, this area is -- earlier we brought in some outside 5 folks that helped us and had a number of discussions. As 6 I think you're pointing out, there's a lot of ways of 7 framing this issues. And how you organize it at some 8 levels is very important, and at other levels is it not 9 that important. You know, as we're laying out the 10 evidence, we can -- I don't want to say tell a story, but 11 you're kind of bringing it together rigid information to 12 work with that doesn't really make sense. 13 I think we use the term "internalizing" 14 versus the "externalizing." I think what your framework 15 here presents is a way that structure is -- types of 16 outcomes to certain -- again, it's a structural way of 17 organizing. 18 I think what we could certainly do is look 19 very closely at this. Perhaps, if nothing else, bridge 20 this by bringing some reference into this context. And 21 there's a variety of ways to work on this. Because 22 otherwise it may have this fairly significant ripple

23 effect. 24 DR. CANFIELD: I think you can have 25 psychologist read this and say, I think, why don't theyMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 117 1 just talk about externalizing behaviors. So if you're 2 going to use the construct of internalizing, it usually 3 goes with externalizing, but -- and I -- so I guess I -- I 4 appreciate that you thought about it carefully. 5 DR. KIRRANE: Yeah. My only comment is 6 that it would be helpful for us if you made your comments 7 as specific as possible, and you have -- and then we will 8 very seriously consider that implementation. But like 9 John said, the extent that it kind of ripples throughout 10 the documents -- I don't think it's relevant in this case, 11 but please make very specific comments and we will 12 consider them seriously.

13 DR. WASSERMAN: I'm not sure we can do that 14 without, you know, moving -- flopping and moving text. 15 So, I mean, I think the issue is organization and 16 subcategories. 17 DR. KIRRANE: I think we (unintelligible) 18 received our -- you know, along the lines of that. 19 DR. WASSERMAN: Okay. Good. 20 DR. CANFIELD: Yeah. I just couldn't tell 21 whether putting externalizing out there, if you could just 22 kind of lay that out and say, Here's what we're needing 23 and let everything else then kind of flow. But that's up 24 -- you know the document at the writing level, so... 25 DR. VANDENBERG: Yeah. What you're sayingMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 118 1 here is -- we've made a big effort to do some 2 reorganization. And I think that the way you've laid this 3 out in your comments is very helpful. We've kind of 4 provided that context. So I think it's clear that this is 5 something that we should very carefully look into. We 6 haven't really done that just yet. But, you know, 7 certainly appreciate the comments.

8 DR. WASSERMAN: It's so much better. It's

9 much better. 10 DR. FREY: If I understand what you're 11 meaning, it sounds like you're talking about a text --

12 DR. WASSERMAN: Yes. 13 DR. FREY: -- category or something like 14 that. And that there may not be an unique one, and that 15 there may be a slightly better one or a significantly 16 better one than what's in there now. But in any case, 17 there's not one, right? And maybe another aspect of it is 18 that just acknowledging that there's more than one way to 19 categorize things, and here's what was chosen and some 20 rationale for that and maybe referencing that there are 21 other ways might also help some of the readers.

22 DR. WASSERMAN: I think there is -- 23 (WHEREIN, unintelligible due to multiple 24 people speaking at once.) 25 DR. FREY: Okay.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 119 1 DR. WASSERMAN: Internalizing and 2 externalizing. 3 DR. FREY: Okay. 4 DR. WASSERMAN: And then with the impact, I 5 think you would have -- you could look at behavior as 6 continuous symptoms towards our diagnosis. 7 DR. FREY: Okay. 8 DR. VANDENBERG: Yeah, if you could -- I 9 don't know if you could pull this up, but on Slide 14 of 10 our presentation -- or maybe you have it in front of you 11 there. What you see is a chart for -- again, it's on Page 12 14. What we're talking about is we've got internalized 13 and we've got attention-related behavior problems. This 14 is some reorganization related to that. You know, in some 15 fashion, it's pretty straightforward. 16 DR. WEITZMAN: I think it's pretty simple.

17 DR. VANDENBERG: Yeah. 18 DR. WEITZMAN: The related table, 5-17, all 19 you need to do is put in external. 20 DR. VANDENBERG: Again, that's very helpful 21 as a way to kind of bridge this effective line. So thank 22 you. 23 DR. KORRICK: Yeah. I think it is simple 24 to it operationally, but I think it's kind of how -- and 25 this is specific to his comment. It's not going to impactMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 120 1 (unintelligible). But I think this was an area where we 2 had some debate about causality and determinations; that 3 it's particularly important. 4 So right now attention to separating it out 5 from conduct and other externalizing behavior -- and you 6 have different degrees of causal assessment for those two 7 outcomes. So when you bind them, essentially, you know, 8 you're going to have to say you had internalizing

9 behaviors -- there's differences in robustness of 10 association for lead in one particular behavior. 11 DR. WASSERMAN: Within a subcategory. 12 DR. KORRICK: Within subcategories. So 13 there's going to be some full effect there. Again, the 14 issue of causality around attention and attention-related 15 behaviors was one that we have (unintelligible) 16 previously. And organizing it this way will help it be 17 clear to everybody, I think. 18 DR. CANFIELD: So one of the problems that 19 you'll encounter is that, when you're talking about 20 attention from a behavior problem standpoint, you're not 21 necessarily talking about the same phenomenon as 22 attention. You're talking about it as a neurocognitive or 23 information processing concept. 24 So I don't envy dealing with the problem or

25 -- but I -- that's what I see. It's some sort ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 121 1 attention that's separated out. And then you have the 2 attention-related -- you know, behavior problems as a ADHD 3 kind of world and clinical world, and that's different. 4 And I don't know whether that's something that you are 5 clear about in your own minds. 6 DR. FREY: Okay. 7 DR. CANFIELD: Why don't we move on to 8 Dr. Kosnett, if you want to take over and let me gather my 9 thoughts here for a second.

10 DR. KOSNETT: Sure. I wanted to add 11 comments to -- about the reversibility and persistency of 12 neurotoxic effects, as they discussed in the document.

13 There's a section on -- 14 DR. FREY: Pull the mic closer to you.

15 DR. KOSNETT: Sure. There's a section in 16 the document, 5-3-12, that talks about lifestyle -- oh, 17 it's not lifestyle, lifestage of exposure. And there's 18 another section, 2.9.5 on Page 2-71 which summarizes some 19 of that. And my comment is this, Section 2.9.5 says it's 20 generally accepted that the effects of lead are not

21 reversible.

22 There's a mention in there of some evidence 23 that there may be some compensation or improvement in the 24 studies. There's more regularity to the discussion in 25 Chapter 5. There's studies in 2009 that show thatMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 122 1 children who had earlier high levels around age two, and 2 then by the time that they got to be about age seven, the 3 blood lead levels had gone down; that they performed 4 better than children do have high blood lead levels at age 5 two and stayed high. So if the blood lead levels come 6 down, they seem to do better. 7 So I think -- is it fair to say -- and I 8 want to get feedback from my colleagues. Is it fair to 9 say that there is -- that the issue of reversibility or 10 compensation, which is hard at times to sort out one from 11 the other, the extent of which it occurs is subject to 12 some uncertainty. And at least in some evidence it 13 suggests that the effects might be partially reversible. 14 Although, more studies -- I just wondered if a slight 15 modification of that is needed. What do you think?

16 Debbie? 17 DR. CORY-SLECHTA: Well, I would also 18 assume in that study that the reason that the blood lead

19 levels came down was because there was some kind of an 20 intervention to actively make sure that happened. I get a 21 little bit concerned because interventions by themselves 22 -- maybe that's like a huge placebo thing. So -- and this 23 is why we know very little about -- right now about

24 academic or other kinds of interventions that are able to

25 reverse the effects of lead. So I'm not convinced on theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 123 1 basis of that; that that would tell us necessarily -- it 2 tells -- it tells me a different story; that -- you know, 3 about the intervention, per se, more than reversibility. 4 And I guess I'm a little concerned about 5 the term "reversibility." 6 DR. KOSNETT: That's right. You're right. 7 Maybe it's compensation. 8 DR. CORY-SLECHTA: Right. Or, you know, 9 it's a proactive intervention. Not, gee, if we just leave 10 them alone -- or just terminate lead exposure that somehow 11 going to go away. We suspect it will go away. And that's 12 coupled with the toxicokinetic issue; that once we 13 terminate lead exposure, we're going to get lead moving 14 back out of the bones. So, you know, that's a dynamic 15 system which means that the whole issue of what's going on 16 toxicokinetically is confounded with that.

17 So I think it's much more difficult. And I 18 guess on the basis of that one study, I'm not willing to 19 say that, you know, reverse -- I wouldn't use the term 20 "reversibility." I think we know nothing about what 21 interventions are actually affected in non-exposed 22 populations from a cognitive standpoint. 23 DR. KOSNETT: Well, then there's a whole 24 section, 2.9.5, and it's entitled reversibility. So it's 25 -- you know, it doesn't mention Dr. Harmon's (phonetic)Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 124 1 study. I don't know. You know, I think it's very 2 difficult to say. Rich, do you want to say something?

3 DR. CANFIELD: No. 4 DR. WASSERMAN: They're all sort of 5 stitched in between reversibility and stalling additional 6 incremental loss. I mean, we looked at exposure that had 7 different trajectories over time. And clearly there was a 8 loss to -- for kids who had worse prenatal and 9 (unintelligible). The kids who had prenatal exposure was 10 associated with a loss. And, however, so is postnatal. 11 So that the issue is not necessarily that you go back 12 that's at the time of that. So it's not really 13 reversible. But maybe you don't continue to take away 14 over time when the trajectory exposure. That's not 15 reversibility. 16 DR. KOSNETT: Well, the -- this is what was 17 interesting is that -- and I think this is true in the 18 Bellinger study, that if you had a high blood lead level 19 at two and your blood lead level came down when you were 20 seven, you performed as well as the kids at age seven that 21 never had a high blood lead level. 22 DR. KIRRANE: I mean, our study wasn't --

23 DR. KOSNETT: That wasn't -- see -- all 24 right. So that wasn't --

25 DR. CANFIELD: That's the exact conclusionMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 125 1 from the Bellinger study. I could be wrong, but I just --

2 I didn't remember it as -- 3 DR. KOSNETT: Well, I -- 4 DR. CANFIELD: It was statistically 5 different. There may have been -- 6 DR. CORY-SLECHTA: I just want to follow-up 7 again. So there's another sort of confound of those on 8 here that I try to keep reminding people of. If you're 9 not doing real well in first and second grade, you're not 10 going to be the valedictorian of your high school class. 11 So even if you stopped lead exposure, the fact that you're 12 behind in reading and behind in math, behind in -- you'll 13 probably lose your trajectory isn't going to be as good 14 anyway without some really proactive intervention. 15 So unsorting that from all these -- in 16 these studies that have gone on in terms of, you know,

17 which blood lead concentrations are the worst or best is 18 very difficult. Nobody has really attempted to do that as 19 far as I know. So, again, I -- you know, I just have 20 reservations about what we would say about reversibility 21 at this point.

22 DR. KORRICK: I think the other issue -- 23 the distinction between reversibility, whatever we can or 24 can't say about it, and compensation is not clearly also. 25 So that if there's compensatory mechanisms because of theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 126 1 developmental (unintelligible) that allow kids to perform 2 better than you might expect at some point, I think that's 3 going to be highly variable in class populations. And 4 it's going to be sort of individual susceptibility issue, 5 and I don't think interpreting the literature based on the 6 promise of individual resistance is necessarily the best 7 thing to do. 8 I think it's just going to be too variable 9 by population and by individual characteristics. Those 10 variability causals are complicated. And it's not only a 11 function of environmental enrichment, but also individual

12 characteristics. I don't know. I think it's a -- it's 13 hard to say for a variety of reasons that lead effects are 14 reversible. And this is just one of the many reasons why 15 experts say that.

16 DR. FREY: I don't want to cut off 17 discussion, but I do want to point out that we are running

18 short on time. So with that I kind of want to circle back 19 to the charge question. I mean, so what we're trying to 20 aim for is what are we going to say to EPA in the charge 21 question. So to the extent they're discussion items, we 22 need to kind of move in that direction. And, Michael, did 23 you want to say something, and then Gail.

24 DR. RABINOWITZ: I've kind of tried to 25 address this way back in Chapter 2. This brings in someMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 127 1 of the problem here about whether or not permanent -- 2 whether or not it's really about permanence of an effect 3 or reversibility effect. I don't know if it helps clarify 4 things to talk about it in terms of permanence or 5 reversibility.

6 I did want to see in the context of 7 neurotoxicity of lead that there are a number of effects 8 of lead on obvious sections and (unintelligible), where 9 the effects really are reversible. 10 Also, I thought the document, in discussing 11 whether or not lead effects are reversible -- they kind of 12 rely on -- too much, I thought, on that the chelation did 13 not result in acute or non-acute. And it may not be -- 14 this is because chelation not only results in 15 (unintelligible), but also redistributes lead in the body. 16 You may have more lead go in the sacral nervous system. 17 So any good chelation they do in terms of expelling lead 18 kind of complicates by being more within the brain. 19 So relying on chelation not to make the 20 child perform better doesn't mean lead itself. It's an 21 effect of chelation rather than lead, per se. Go ahead. 22 Thank you. 23 DR. WASSERMAN: It's good to know the 24 strength or limitations of the evidence. We talk about 25 child parental psychopathology as a contributor, asMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 128 1 something that needs to be adjusted or -- consistently 2 through this chapter in several places, it uses almost the 3 same language that the relationship between parental 4 psychopathology and the original behavior or additive 5 behavior is unclear, so we dismiss it.

6 That's not the reason those studies are 7 compelling from parental psychopathology. It typically 8 could be part of the reason, but most forms of behavioral 9 disorder -- behavior problems are highly inheritable, 10 including all of conduct problems, all internalizing 11 problems. And the reason you would want to have that in 12 there is to pull that up. 13 So it's not -- it's a narrative, which I 14 agree mushy at best. It is in there in and of itself, and 15 important in and of itself. 16 DR. KOSNETT: I saw that point and I agree 17 with you. 18 DR. KORRICK: Yeah, I mean -- well, that 19 does come up a lot, and it's repeated throughout. 20 DR. WASSERMAN: The same language.

21 DR. KORRICK: But I think the issue is the 22 -- the issue is it will improve your estimate of lead 23 effects if you adjust for that because it's an important

24 determiner between the documents. But if it is not 25 confound or if it's not related to parental qualityMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 129 1 parenting. 2 So I think one argument to be made is 3 there's no good evidence it's related to quality 4 parenting. Failure to adjust for it may diminish the 5 precision of your lead effect estimate, but it should not

6 confound it. It should not bias it. So that's a 7 distinction that's important in the issue of, you know, 8 causal -- the strength of it would turn causality. And I 9 don't know if that was the intent -- was intended by that 10 language in the document or not. 11 (WHEREIN, unintelligible due to multiple 12 people speaking at once.) 13 DR. WASSERMAN: If a parent has a 14 behavioral disorder and is -- has antisocial personality 15 disorder or something and rears, one of the components of 16 that is neglectful parenting. 17 DR. KORRICK: Right. 18 DR. WASSERMAN: So you might not clean your 19 house, or you might not watch your kid when he's chewing

20 on the windowsill. 21 DR. KORRICK: But, no. I think it's a 22 legitimate concern as a confounder. But I think that if 23 there is uncertainty about whether parental 24 psychopathology affects those behaviors -- and, in fact,

25 in some cases it doesn't. Then it's not confounded.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 130 1 So I guess the question is -- I mean, this 2 is sort of a minor point, but if there's uncertainty about 3 the relationship between parental psychopathology and 4 those behaviors, then -- then you can't set it forward as

5 confounded. 6 DR. WASSERMAN: But lack of parenting is a 7 symptom. 8 DR. KORRICK: Right.

9 DR. WASSERMAN: It's a criteria for -- 10 (WHEREIN, unintelligible due to multiple 11 people speaking at once.) 12 DR. KORRICK: Right. So maybe that 13 statement that's being used, if that's well-established --

14 which I don't know that were their term -- the statement 15 that it's uncertain what the relationship is to parenting

16 is the incorrect statement and needs to be corrected. I 17 don't know. I mean, that comes up a lot in the documents, 18 though. If you feel that's incorrect, that's actually an 19 important point just because it's a consistent theme. 20 DR. FREY: Okay. Other comments on Chapter 21 5? Susan -- or Rich, do you have something? 22 DR. CANFIELD: (No response.) 23 DR. FREY: Oh, well, I was going to wrap 24 up. And so if you have something, you know -- 25 DR. CANFIELD: Well, I did want to makeMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 131 1 sure that I had the -- on the record that I think with 2 respect to the reversibility that we -- the interpretation 3 of the animal enriched environment study, if we could look 4 back at that and see if it -- you might think about it as 5 a deprivation versus experiential exposure to 6 complexities. Isn't that the group that was not given 7 enriched environment is actually in a impoverished 8 environment, and that is achieved (unintelligible) 9 evidence for reversibility in that setting. 10 Okay. I have some other things in mind, 11 comments, but I think most of them are pretty 12 straightforward. So, thank you. 13 DR. FREY: Susan, do you have feel that you 14 have the input that you need? Is there anything you need 15 from the panel that would help clarify what -- get them 16 right? 17 DR. KORRICK: Yeah. I think I'm okay. 18 DR. FREY: Okay. All right. Good. All 19 right. Well, I propose let's continue to Chapter 6. And, 20 you know, if there's some burning issue that comes up, we 21 can circle back if needed. But just in the interest of 22 time. So Chapter 6 is Potentially At-Risk Populations. 23 And the lead discussant is Deborah Cory-Slechta and then 24 Gail Wasserman and Michael Weitzman. So Deborah, you have

25 the floor.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 132 1 DR. CORY-SLECHTA: Okay. So I -- in my 2 estimation, the chapter was much, much improved over last 3 time. It's reorganized. There's better delineation of

4 what I would consider some of the sources of the risks and 5 the -- I thought the discussion of at-risk vulnerability 6 and susceptibility was very, very helpful. And the 7 chapter does a better job of summarizing the strength of

8 the evidence. 9 Now, what I saw is missing, and you guys 10 brought it up this morning, is any discussion of the 11 relative magnitude of these interactions of these risk 12 modifiers. And what you stated was that it's very 13 difficult to come up with some kind of estimation. 14 But, you know, the fact of the matter is 15 that I -- when I read it now, I can't tell which, if any, 16 of these factors are more or less important. And from a 17 policy point of view, I think that really matters because 18 EPA is committed/required to addressing vulnerability. 19 But right now if I have resources or

20 limited resources -- I don't know which one of these were 21 which, you know, of the set of these should I be more

22 concerned about. 23 And I think what you brought up today was 24 well, how would we go about doing that? Maybe if you 25 could in at least a range of effects, you know, there'sMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 133 1 overlapping effects. But give us some idea of the range. 2 Are we talking about 1 percent changes or 20 percent 3 changes with respect to, you know, a (unintelligible) or a 4 diet, whatever. Just give us some idea of the range. 5 At the end of the day, I fully understand 6 that, you know, the -- in a way we're trying to determine 7 whether the safety factors that we've been slapping on to

8 these reviews relate to what we know from the literature. 9 And you can't really pull it out, but at least give us 10 some idea of where these things fall on a scale of 11 magnitude. You know, one fold increase, something like

12 that. 13 And that was really my primary comment on 14 Chapter 6. 15 DR. FREY: Okay. Thank you. Let's see,

16 Dr. Wasserman. 17 DR. WASSERMAN: I think it's greatly 18 improved, but the section -- and then maybe this is just 19 stylistic. The sections on risk I thought -- sometimes 20 now, rightfully so, include multiple endpoints and 21 different associations for different subgroups. And you 22 have to read through the whole paragraph or section to 23 come up with an integrating perspective. I don't know 24 whether it would be helpful to give the reader that at the 25 beginning of the paragraph because I kept reading itMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 134 1 thinking, Oh, that's appropriate; oh, no, it isn't. Or, 2 Oh, there were two girls; no, that doesn't work for boys. 3 And it was hard to pull it all together. 4 Whereas, if you had told me what I should 5 be looking for first, then I would have been able to 6 follow it. So I'm of the school that you say what you're 7 going to say, say it, and then say what you said. But 8 that's a lot of nothing. 9 And then occasionally the sections that 10 considers both human and non-human studies, without 11 clarifying exactly which it is -- and I think that is a 12 vital -- a very important distinction so that it would be

13 useful if each sentence sort of or each discussion of a 14 study brought us back to what the population of species

15 that were studied. And that's it. 16 DR. FREY: Okay. Michael. 17 DR. WEITZMAN: Thank you. I thought that 18 the chapter read much better in treating how each time I 19 view it I see things that I missed before, but I think are 20 still missing. So the lesion is as much with me as with 21 anybody else. 22 Having said that, I have a number of 23 comments that I don't think we need to discuss at large. 24 But there are a couple that we've touched upon, where 25 we've intubated but not dealt with in this particularMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 135 1 section. 2 So for example, when we're speaking about 3 reversibility or exposure, I think that there needs, in 4 this section, to be some acknowledgement. But we don't 5 know how critical it is of exposure or whether it's 6 cumulative exposure or peaked at a particular age. So 7 that's not especially a large issue. 8 I do think that one of the things -- and 9 I'd love to hear feedback from other people. One of the 10 things that we've not talked about is that there are, from 11 a public health perspective, a very large number of 12 children with preexisting conditions that one could 13 hypothesize would place at an increased risk, given the 14 same lead exposure. So I'm talking about premature 15 babies, with those that have birth asphyxia, head trauma 16 or any host of things; prenatal exposure to alcohol, 17 cocaine or heroin, tobacco. 18 You mention at one point where the -- or 19 the chapter mentions that there's one study on prenatal 20 tobacco exposure and increased risks of ADHD, but you have 21 over 30 percent of our children living in households with 22 smokers. So (unintelligible) running in the second-hand 23 smoke exposure. They have deleterious effects that may be 24 additive, or they may preclude the lead effects or 25 diminish them. If, in fact, the same neurotransmittersMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 136 1 (unintelligible) functions are effective. 2 There is one significant group of kids that 3 we haven't mentioned at all, and it's just a pretty easy 4 thing. And that's kids with sickle cell anemia tend to 5 get a peripheral neuropathies. And that was noted in my 6 previous discussions of this. 7 And then the only other thing that I have 8 for you is that the section on socioeconomic status and 9 race/ethnicity. It needs to be updated. We use data from 10 the 2000 census, and the population of children in the 11 United States in the past ten years is changing more in 12 terms of demography than it has any prior -- to any other 13 period in the United States. 14 And so many of those children's families 15 are largely coming from Asia and the Middle East, and so 16 they'll probably have multiple different avenues of 17 exposure. I don't know if there's any reason to assume 18 that given the same exposures they'd have different 19 outcomes. So I hope that's helpful.

20 DR. FREY: Gail. 21 DR. WASSERMAN: Smoking is, indeed -- 22 prenatal smoking is one of the strongest risk factors for 23 ADHD, so it definitely should be in there and an active 24 point. And enough said it's just for smoking status, 25 looking at behavior problems. And some of the studies didMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 137 1 have it, but it should be something to expand on. 2 DR. VANDENBERG: You know, just to clarify. 3 So, you know, some instances where we've got some specific 4 evidence and then others, as you were just citing, might 5 be more hypothetical. And so I think what we're trying to 6 do is portray the data that is available and not being 7 irrespective, even though it seems very reasonable. So -- 8 did you have a comment?

9 DR. KIRRANE: Yeah. I had kind of a 10 specific question. So if you look at the slide, the 18th 11 slide. So for example, you had said you can't look at the 12 factors that were evaluated and just get a sense of what's 13 the most important one. So obviously I think everyone 14 would agree that childhood is a very important, you know, 15 in terms of lead exposure. But the evidence comes from 16 longitudinal studies, studies that don't have comparison 17 groups. So if we put a range of effects on asking myself, 18 Okay, so children versus adults or -- it doesn't make 19 sense in that -- so that's the kind of -- when we try to 20 do this, we try to do it, you know, methodically across 21 all the factors. And that's the kind of problem I'm 22 anticipating. 23 DR. VANDENBERG: So we have suggestions and 24 considerable outcomes on how do we do that. One thing we 25 did try to portray, for example -- and I think -- IMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 138 1 mentioned about Raytheon (phonetic) -- Raison (phonetic),

2 I think is his name. Where we have some differences of 3 (unintelligible) groups. They aren't -- they are 4 statistically significant. 5 That was one way of portraying that. 6 Doctor, I'm not sure if that's what you were referring to, 7 but any suggestions about how we might bring more 8 information forward to give that sense of, These are the 9 big ones; these are not such big factors, we certainly

10 welcome. 11 DR. CORY-SLECHTA: Well, I think it may be 12 relevant -- it may be that you have to use different 13 mechanisms for different comparisons. Okay. So, you 14 know, what's happened in the case childhood versus adults 15 in the past. You know, we've seen these lines of blood

16 lead in neo-children. The effects are down here and the 17 adults start up there. So maybe something like that. 18 I'm also interested, though, if you have a 19 genetic polymorphism. You know, there's a lot of text 20 about, you know, well, they have this oleo or that. But 21 it's the outcome difference of 1 percent difference. You 22 know, so maybe different kinds of metrics, depending on 23 which comparisons we're talking about kind of thing. 24 You know, just off the top of my head, it's 25 one that I'm sort of thinking about. It may not be thatMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 139 1 you could be consistent. But if I'm a policy person at 2 EPA and I have limited resources, I want to know where I 3 can invest my money. I mean, I already know that 4 childhood is one thing. But should I be more worried 5 about X, Y and Z in childhood. You've got -- you know, so 6 sort of how can I package these in terms of where I might 7 go with my resources.

8 DR. FREY: Yeah. 9 DR. CANFIELD: Maybe I'm not remembering 10 something. I was thinking that this table included both 11 risk factors with respect exposure and also one with 12 (unintelligible), which means then it got more things 13 going on here. I can't see a way to put a single

14 statement on it. 15 DR. VANDENBERG: We have previously -- 16 we've gone through a number of iterations about 17 susceptibility and vulnerability, behavior versus 18 (unintelligible). And this is, this is an ongoing

19 discussion as to how to best frame that. 20 DR. CANFIELD: I like the discussion, you

21 know. 22 DR. VANDENBERG: Yeah, it's a continued 23 thing to try to refine addressable in the nature of a -- 24 of what, and so we certainly welcome your comments on

25 that.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 140 1 DR. CORY-SLECHTA: Well, you know, the risk 2 group -- the risk one that is working on this might see 3 what they think is elaborate. But they're certainly 4 looking to be able to pull these into the risk assessment 5 more directly instead of a safety-net approach. So maybe 6 they have something. But, you know, again, I'm not 7 convinced when I sort of try to think about what 8 comparisons I looked -- to me, I think we're going to have 9 a one size fits all. I just don't think we can. 10 DR. FREY: Okay. Are there other comments 11 on Chapter 6? 12 (No response.) 13 DR. FREY: Deborah, do you feel like you 14 have the input you need? Do you have any questions for 15 the panel? 16 DR. CORY-SLECHTA: No. I'm okay. 17 DR. FREY: All right. Let's move on to 18 Chapter 7. And the discussants of Chapter 7 can take as 19 much time as they'd like. The only thing between us and 20 lunch is Chapter 7, so -- so Dr. Allen is the lead 21 discussant, and Drs. Johnson and Lanno also are designated

22 to discuss this. So Dr. Allen. 23 DR. ALLEN: Draft 3 is fantastically 24 improved over the earlier versions. You really have done 25 an excellent job. It's well-written. It's lengthy, butMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 141 1 it's reasonably easy to follow. And that -- we'll come 2 back again. It is long. You've done a really good job on 3 summarizing and integrating a huge amount of information. 4 By now reporting all of the concentrations -- or I should 5 say almost all the concentrations in mass units; that is 6 either milligrams/kilograms or milligrams per liter rather 7 than some in mass and others in molar units, it's much 8 easier for everybody to make comparisons among those

9 studies. 10 However, going along with improving it and 11 making it easier to read, makes it easier to find where 12 some improvements can be. And so it's -- I'd like to say 13 these are not as a real criticism, but as something to 14 follow on your improvements. All right. 15 First, it struck me, reading through here, 16 was it's now really clear that the concentrations 17 producing effects vary by many orders of magnitude. You 18 have ranges and effects attributed to them in your 19 Synthesis of New Evidence chapter -- or section, sorry. 20 They summarize this really well. And a Causal

21 Determination sections that follow that. But it isn't 22 easy to see where everything comes from. All right.

23 There is a lot of information in the tables 24 at the end, which is also very good. But what I would 25 like to suggest is the following. All right. Add aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 142 1 graphic for terrestrial and add a graphic for aquatic

2 effects that relates the various effects on the abscissa 3 to concentration on the ordinate. All right. You know, 4 go X's or bars that show ranges of things. 5 This is helpful in framing where you are, 6 what things are important and relative -- within relative 7 importance of one effect relative to another effect. And 8 now there's just so much material that a summary like this 9 would really help. All right.

10 The effects -- some of the effects that we 11 -- that you cite in there are real, no question about 12 that. They obviously see these. But they -- 13 applicability of these to environmental situations is 14 either unproven or probably not there at all. All right. 15 And that doesn't come through. These are presented one 16 after another or with equal weight in terms of writing for

17 all of them.

18 And I went back to take a look at this. 19 The ISA has concentrations that vary by eight orders of 20 magnitude. Eight orders of magnitude. That's far more 21 than what the environmental range is, by many orders of 22 magnitude. The environmental range is only two or three 23 orders of magnitude, which we consider to be big. Eight 24 orders of magnitude is just -- I don't know what to do 25 with it. All right.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 143 1 So that is where I think that graphic would 2 come in there because if you were on blood lead levels 3 scale, you could see -- and put in there what the 4 environmental range is and what the environmental range, 5 then everybody can see, well, these are effects that 6 people saw, but they're way above the environmental range.

7 That's Point 1. 8 Point 2: A primary factor that controls 9 bioavailability in both aquatic and terrestrial systems is 10 the solubility of the tested material. If you put in -- 11 you know, I can add in lots of lead to my fish aquarium by 12 throwing stones in. All right. You know, unless I hit 13 the fish on the head, I'm not going to really worry about 14 what the effect on the (unintelligible) would be. All 15 right. 16 So solubility really has to be dealt with. 17 Lead typically is added as a chloride or the nitrate 18 salts. Both dissociate completely to release lead ions. 19 Lead ions can react with ligands in the solution to form 20 soluble complexes and insoluble precipitates. All right. 21 For solutions that are near neutral pH, the 22 solubility of lead is fairly low. And many of the 23 concentrations reported in the literature likely exceed 24 the solubility of lead hydroxide, cerrusite or 25 hydrocerrusite. Incidentally, hydrocerrusite is the leastMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 144 1 soluble, and it is not mentioned anywhere. 2 You need to, I think, have a paragraph that 3 discusses solubility and the importance of solubility in 4 terms of exposure. And how you calculate this -- our -- 5 and EPA has a wonderful computer program, that's this 6 MINTEQ. 7 To finish this. An example, all right, of 8 this is there is a discussion of foliar proline 9 concentrations in a macrophyte were reported to increase 10 in concentration-dependent manner as the lead 11 concentration increased from 20,720 to 1,036,000 of 12 micrograms of lead per liter. The upper concentration is 13 over 1 gram per liter. 1 gram of lead per liter is 14 soluble and the pH is too. It just wasn't the solution. 15 So what to make of the study, I don't know. 16 The relevance of the study -- the relevance of a gram per 17 liter of lead -- if I'm an industrial discharger, I'm -- 18 first of all, the state's going to fine the hell out of 19 me, you know, if I'm discharging anything near that. But 20 now I'm wasting material. These are recoverable ranges. 21 So, you know, again, what's the relevance 22 of some of these things. And that's, I guess, all I need 23 to say. 24 DR. FREY: Okay. Thank you. Dr. Johnson. 25 DR. JOHNSON: I agree that the quality ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 145 1 this chapter of the document has improved tremendously

2 over the three drafts. 3 A couple of -- just a couple of minor 4 comments. One is sort of a literary one. It's that you 5 added a section called Fate and Transport of lead in 6 Ecosystems, presumably in response to concerns that this

7 should be an add. 8 But -- so it's there. It's nice enough. 9 It's assigned. But none of the material in that is ever 10 really brought back later in the, in the chapter. I note 11 in particular there's a section that talks about 12 half-lives and the time to reach steady state and all 13 that. And none of those values are, you know, ever 14 brought back later. You know, it just makes you wonder 15 why this -- it's necessary to have that stuff if it's not

16 used later. 17 The table in the appendices -- the tables 18 in the appendices are fantastic. I -- you know, they're 19 -- it's so good to be able to, you know, go through those 20 and see the different key studies and threshold levels. 21 It's like that -- really, really well-done. I really like

22 that. 23 I guess the only real major substantive 24 comment I have is just -- and it's something we've talked 25 about before, which is that the -- in trying to understandMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 146 1 ecosystem effects for the air-quality standard means that

2 at somewhat we have to relate air concentrations to 3 concentrations in soils, terrestrial systems, water for 4 aquatic systems. 5 And there's a real -- you know, there's a 6 real disconnect, a real inability to make meaningful 7 relationships for those. And -- and so, therefore, to try 8 to understand -- to try model effects and come up with 9 relationships that can be used to set a standard becomes 10 really difficult. 11 This will come up again in the PA 12 discussion tomorrow. But, you know, I think it's a -- you 13 can hope that maybe there will be sufficient data in the 14 future to close the gap, but I think it's also appealed 15 to, you know, movements -- we're going relationally 16 forward in this regard to a critical load-type approach 17 for looking at ecological effects of lead because -- you 18 know, trying to do it with large CL data analysis is 19 probably -- given the amount of work that is going on or 20 not going on in the United States, it's hard to imagine 21 that we're ever going to get to the point where there's 22 enough field data to do it without some kind of critical 23 loads approach. 24 And I guess just to close that discussion, 25 I noted in reading through Chapter 3 it talked aboutMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 147 1 precipitation lead. And the first sentence of this 2 section, it says, there's currently no precipitation 3 monitoring for lead in the United States. 4 I can't believe that. I mean, this -- 5 there's no regular monitoring of precipitation of lead in 6 the United States. So in terms of us, you know, 7 suggesting for research -- or not research even, just 8 monitoring it. 9 It seems to me that you would pick lead as 10 sort of an -- even if we're in sort of a sunset period for 11 lead and, you know, lead as a concern as an ecological 12 pollutant, it seems to me we ought to do -- note the -- 13 monitoring elements that are falling onto our ecosystem 14 and moving though them, so -- and that's it. 15 DR. FREY: Okay. Thank you. Dr. Lanno. 16 DR. LANNO: Thanks, Chris. First, I'd like 17 to reiterate what Drs. Allen and Johnson said, is that 18 this is a great improvement of the previous drafts. And I 19 really approve of the tables at the end. And as Dr. Allen 20 said, one of the pitfalls is reorganizing the data in a 21 very equal fashion as to answer the questions.

22 It was nice to see a breakout of the 23 freshwater and saltwater data so you can make heads or 24 tails of that and justify that based on bioavailability. 25 So in looking at the tables, one of the problems that IMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 148 1 have -- or one of the problems that I kind of come up with 2 was -- as Dr. Allen suggested, that we get a figure 3 together that would summarize terrestrial and aquatic 4 exposures and the background concentrations or violently 5 levels you'd expect to see.

6 And where these effects occurred was we had 7 this issue about expressing concentrations in chemicals in

8 either mass volume or mass -- mass basis. And so we moved 9 to draw the Chestfield data. You've got many situations 10 where you have no (unintelligible) with lead in the 11 studies, and that's fine. 12 But what do you do with hydroponic data. 13 So you have a mass volume perspective from milligrams to 14 liter exposure to -- micrograms and milligrams to liter of 15 lead exposure in hydroponic systems, but I don't know how 16 you put that all together in one figure using those old 17 expressions of data and such. 18 So you may have to just justify that. 19 Maybe not including the hydroponic data, maybe not 20 including (unintelligible) or something like that.

21 So relevance of those two actual 22 environmental scenarios maybe should be clarified a bit. 23 And to follow along with that, many of the studies have 24 nominal concentrations. For the life of me, I'm not sure 25 what (unintelligible). That just adds some confusion toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 149 1 what the actual exposure dose is of lead in the system. 2 So if you were to include the nominal 3 values on the figure, it might be indicated as a different 4 color or a different symbol than the actual measured 5 values. And before a figure, I would suggest that maybe 6 you go to the U.S. EPA (unintelligible) document and see 7 how they set up their different concentrations and 8 different responses to -- lethal responses to the survival 9 than they have whole organisms -- sublethal responses, 10 like growth and reproduction. They have the subordinates 11 and biomarker types. 12 But that would be a good place to take a 13 look at a figure to start summarizing data. I have 14 further comments, but we can just talk about that later. 15 DR. FREY: Okay. Great. Other members of 16 the panel, comments on Chapter 7? Oh, I'm sorry. Go

17 ahead. 18 DR. RABINOWITZ: Quick question. Does EPA 19 monitor precipitation for anything, or they monitor it for

20 lead? 21 DR. CANFIELD: Yeah, there's the 22 atmospheric that's the ascitic deposition that someone 23 spoke about (unintelligible).

24 DR. FREY: Yeah. 25 DR. KOSNETT: I had a question of myMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 150 1 colleagues who were focusing on the logical impacts that 2 were discussed a lot in Chapter 7, but there's a section 3 in Chapter 2, 2.9.7, which is clearer in this document 4 than compared to the last document. It's called 5 Ecological Effects and Corresponding lead Concentrations. 6 And it has a sentence in there, it says:

7 There is limited evidence to relate ambient lead

8 concentrate -- ambient air concentrations of lead to 9 levels of deposition onto terrestrial and aquatic 10 ecosystems and to subsequent movement of 11 atmospherically-deposited lead through environmental 12 compartments (e.g., soil, sediment, water, biota). 13 And I read that and I said, There's limited

14 evidence that relate to air concentrations of lead to the 15 ecosystems. And I'm wondering if you agree with that 16 because we -- from a unity epidemiology perspective and 17 clinical perspective, we found that when there's elevated 18 levels of lead being emitted into the air, there's -- I 19 wouldn't call the evidence limited to say that you don't 20 think it's healthy in children. And there's a lot of 21 Superfund studies and everything that show that there's a 22 relationship. It may not be the current air lead. 23 DR. ALLEN: You're looking at the a 24 suspended (unintelligible). To get to ecological 25 receptor, those have to be positive, be soluble andMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 151 1 transported and then be wrapped. There's a lot more 2 stages in not monitoring -- and that's the -- that's the 3 critical loads information that we were discussing. And 4 we don't have good critical loads models. We don't have 5 models, really, that allow us to do how emission of lead 6 from, say, a stationary source that then effects the 7 ecosystem or all its transports.

8 DR. KOSNETT: So we know more about the 9 human ecosystem than the -- 10 DR. ALLEN: Yes. Yes. It's a much simpler 11 system.

12 DR. KOSNETT: We know much more about urban 13 settings than --

14 DR. ALLEN: Yes. Yes. Yes. 15 DR. HOPKE: I forget you've got solid 16 surfaces (unintelligible) depositing in the soil that --

17 which is soluble. There was a lot of that -- there was 18 some of that worked on in the settings (unintelligible), 19 but that was a high level. You know, we have different 20 sources now to be used in the composition particles, and 21 their chemistry in the environment is not going to be the

22 same. 23 (WHEREIN, unintelligible due to multiple 24 people speaking at once.) 25 DR. ALLEN: Michael, there's another largeMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 152 1 difference that I see between the ecological system, and 2 that is that we see effects much lower in dosages than 3 what we see here. And overall, when I look at a number of 4 this (unintelligible), I find when I look at the logical 5 ones, the most sensitive endpoints are depth. And that 6 makes no sense at all biologically. And that means that I 7 don't -- I think what that means is that we really don't 8 understand the ecological system well. We sure as heck 9 don't understand biomarkers in ecological systems.

10 DR. JOHNSON: The connection between air 11 concentrations and deposition is sort of -- this section 12 starts with looking at the long and hard studies going 13 back through the period of use of lead gasoline, for some 14 sites there is good, sufficient basis to relaying 15 emissions to deposition. But in many of these studies, 16 and the ones I know of, they emitted air concentrations. 17 If you can kind of get the air concentrations, you can 18 kind of back into that way. But, again, that's -- that's 19 characterizing the whole argument of that lead gasoline 20 created. Whether those relationships would hold now, 21 they're very much different. It's unclear. 22 DR. FREY: Okay. 23 DR. KOSNETT: Can I say one other thing?

24 DR. FREY: Sure. 25 DR. KOSNETT: I wanted to -- I asked youMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 153 1 something earlier about Dr. Bellinger's study, on that 2 reversibility. And I think I mischaracterized that. It 3 was prenatal effects that -- in Dr. Bellinger's studies 4 that assumed to dissipate or -- 5 DR. CANFIELD: That was Bayley effects that 6 considered -- that found the (unintelligible). It's not 7 clear whether it was a change in instrument or a change in 8 -- a measurement change. 9 DR. KOSNETT: He stills shows that during 10 the fact of two -- that two years of age -- 11 (WHEREIN, unintelligible due to multiple 12 people speaking at once.) 13 DR. KOSNETT: No. On later, on later life 14 effects, in his perspective study. There was another 15 study by Dr. Cheng and Ken Dietrich (phonetic) that looked 16 at their cohort and looked at the TOC setting. And they 17 felt that at age -- that the children that came down by 18 age five, compared to the levels of two, improved. 19 DR. CANFIELD: In that one study? 20 DR. KOSNETT: Yeah. Right. 21 (WHEREIN, unintelligible due to multiple 22 people speaking at once.) 23 DR. KOSNETT: But, anyway, I 24 mischaracterized it. It was the prenatal effect. And 25 that was in this publication that I -- in the PHP in 1990.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 154 1 I just wanted to clear that up for the record. 2 DR. FREY: Okay. Thanks. Anything else on 3 Chapter 7? 4 (No response.) 5 DR. FREY: Okay. I think, actually, some 6 of Dr. Kosnett's comments prompted me to -- it would be a 7 good idea for the discussants on each of the Chapters 3 8 through 7 to also give some thought as to whether there's 9 implications for -- I guess especially Chapter 2, in the 10 summary if there are any, you know, issues that, you know, 11 are not clearly communicated or if there's a mismatch or 12 something missing or so on, for Chapter 2, if you could

13 make sure to let Michael know that since he's the 14 coordinator of the comments on Chapter 2. 15 So please give that some thought. So I 16 guess I'll specifically mention the lead discussants of 17 Chapters 3 through 7 are George, Sean, Susan, Deborah and 18 Herb. But really I think it's a kind of panel-shared 19 responsibility.

20 DR. WASSERMAN: Will the comments in 21 Chapter 2 change as we justify the changes? 22 DR. FREY: Yeah. We certainly can do that. 23 I mean, so we -- 24 (WHEREIN, unintelligible due to multiple 25 people speaking at once.)Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 155 1 DR. FREY: But to the extent -- you know, 2 and I guess, also, there may be things that in the 3 chapter, are important to fix in that chapter that may not 4 have implications for Chapter 2. All I'm saying is just 5 be mindful of it. If you see a link, it helps to call

6 that out. 7 We'll definitely consider that in our 8 review of -- our later review of our responsive charge 9 questions, which we are planning -- again, as I mentioned 10 earlier, we'll have a teleconference on April 1st to go 11 over a hopefully close to final draft of the response to 12 charge questions, and we can definitely come back to this 13 issue of concordance among the charge question responses. 14 I know we have at least one clarifying 15 comment, which Aaron now will communicate. I think as far 16 as other issues here, I think we've covered everything we 17 need to cover. So I'll let Aaron communicate any 18 clarifying comments and also I think if there are any 19 housekeeping announcements, and then I'll just make a 20 couple of quick remarks. 21 MR. YEOW: Okay. So we have one request 22 for a public comment. But she was not able to be on the 23 line, but she asked me to read something. And I will not 24 try a female voice impersonation. Okay. So these are 25 public comments from Anita Meyer, Department of DefenseMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 156 1 Chemical and Material Risk Management Program. Well, I 2 should also note that these have been e-mailed out to you, 3 and they're available on our website was well. 4 The Department of Defense Chemical and 5 Material Risk Management program would like to call the 6 Panel's attention to a recent (Dec 2012) National Academy 7 of Science study funded by DoD titled "Potential Health 8 Risks to DOD firing Range personnel from Recurrent Lead 9 Exposure". 10 The recent findings in this report would be 11 useful for inclusion in Section 4.1.3.4; for example one 12 of the major findings is that "...the OSHA standard 13 provides inadequate protection for DOD firing-range 14 personnel and for any other worker populations covered by 15 the general industry standard. Specifically, the premise 16 that maintaining blood lead levels under 40 μg/dL for a 17 working lifetime will protect workers adequately is not 18 valid." As a result of this report's findings, the DoD is 19 reviewing its guidelines and practices for its firing 20 range personnel."

21 So that's it for that comment there. And 22 then -- so in terms of housekeeping items, lunch is not 23 provided and the hotel does not have lunch. So we're 24 going to have to -- and Leslie has a list of restaurants

25 out front here.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 157 1 And the hotel might provide a shuttle, I 2 think, but it only can take like six at a time or 3 something like that. So, you know, I walked it last 4 night. There's a shopping center about ten minutes away, 5 and it has a lot of stuff in there. It's not a bad walk, 6 it's like ten minutes. And, you know, we did eat a little 7 bit in the lunchtime, but we still have a good hour and a

8 half for lunch. So it should be sufficient time for that. 9 But if you need a list of restaurants or whatever, you can 10 check with Leslie out front here. And then I'll just turn

11 it back over to Chris. 12 DR. FREY: Okay. Well, just a reminder to 13 -- on the homework assignment to -- I think while it's 14 fresh is a good time write the draft responses to the 15 charge questions. And if you can e-mail those to both me 16 and Aaron anytime this evening, that would be great so we 17 can get a sense of where things are. 18 I would like to thank the EPA, the National

19 Center for Environmental Assessment and all of their 20 hardworking staff there. And, John, if you would like to 21 say something? 22 DR. VANDENBERG: I would just like to 23 extend our appreciation. I think it's been a very helpful 24 discussion this morning. The written comments are very, 25 very helpful. So, again, thank you for your sustainedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 158 1 support. We very much appreciate it.

2 DR. FREY: And at what time did we want to

3 ask and see for the fourth draft? No. I think we will 4 find -- I think it's fair to say we'll find that the -- 5 with our comments that the ISA is adequate for its 6 intended purpose. They're bringing the endorsement that 7 you're looking for. 8 (WHEREIN, unintelligible due to multiple 9 people speaking at once.) 10 DR. FREY: But we're not -- as a panel, 11 we're not asking for a fourth draft. No. Okay. All 12 right. Well, with that, have a good lunch. 13 (WHEREIN, a lunch recess was taken from 14 12:44 p.m. to 2:17 p.m.) 15 DR. FREY: Okay. Let's please get started. 16 Welcome back from lunch. Our agenda this afternoon is -- 17 we'll start with a presentation from EPA on the draft 18 policy assessment. We have a couple of comment sessions 19 scheduled, but we don't have any public commenters. So 20 we'll move then into the panel discussion. And today 21 we're scheduled to try to cover Chapters 1, 2 and 3 on the 22 policy assessment before we break. And then tomorrow 23 morning we'll cover Chapters 4, 5 and 6. 24 And as mentioned earlier, if there are any 25 public comments -- there is an opportunity for clarifyingMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 159 1 comments from the public at the end of tomorrow morning's 2 session. Are there any panel members on the phone? 3 (No response.) 4 DR. FREY: Okay. All right. Well, with

5 that I would like to turn the floor over to the EPA's 6 Office of Air Quality Planning and Standards. 7 MS. WEGMAN: Thank you, Chris. Good 8 afternoon everybody. My name is Lydia Wegman. I am the 9 director of the Health and Environmental Impacts Division 10 in the Office of Air Quality Planning and Standards. And 11 it's my division that has done the work on the risk and 12 exposure assessment and the policy assessment as well as 13 the work that's been done by our sister division, The Air 14 Quality Assessment Division. 15 And I'll just quickly introduce the folks 16 that are here. Dr. Deirdre Murphy, Ms. Ginger Tennant, 17 Dr. Karen Martin, Mr. Kevin Cavender. Where's Zach? I 18 can't see him. Dr. Zach Pekar and Mr. Lewis Weinstock,

19 he's in the back there. And all of us are here and 20 available to answer questions as discussion proceeds. 21 Okay. I think many of you are familiar 22 with this slide, but I just want to remind folks what the 23 process is that we go through in setting National Ambient 24 Air Quality Standards. And then the next page I'll go 25 through the schedule for this particular review.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 160 1 But overall we start with a kickoff 2 workshop. We have -- if you go to the middle of this 3 slide, you start with an integrated review plan, which we 4 have done. We have the integrated science assessment. 5 And you, of course, have been reviewing the third draft of 6 that ISA today. We'll also be -- you have also reviewed 7 the risk and exposure assessment, in this case the only 8 draft we have planned for that -- yeah, just the planning 9 documents on that one. And then you have reviewed the 10 draft of policy assessments. 11 And as you can see on the far right, you 12 review all of these documents and we also take public 13 comment. The next step after we complete this process is 14 to develop a proposed rule. And this is on the -- toward 15 the bottom on the left. And we propose a decision -- 16 well, we draft the proposed rule. And that goes to the 17 interagency group, which is a group managed by the Office 18 of Management and Budget. 19 And we issue the proposal, and we have 20 public hearings and we take comment. And then we have the 21 draft final notice, which again is reviewed by the Office 22 of Management and Budget and other interested federal 23 agencies. And then we get to the final decision on the

24 standard. 25 So you can see why this process can take aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 161 1 minimum of five years. Was there a question? 2 (No response.) 3 MS. WEGMAN: No. Okay. 4 DR. WEITZMAN: When do you start again? 5 MS. WEGMAN: When do we start again? Well, 6 we are in the middle right now, as you know, of the lead 7 review having completed the last one in 2008. So we will 8 move forward. And as you will see from the next slide, 9 we're not going to make our five-year schedule. But we're 10 going to be darn close.

11 So where are we in this review. The red -- 12 the highlights in red are where we are today at the 13 meeting with you. And, of course, this afternoon we'll be 14 talking about the draft policy assessment. 15 We plan to issue the final policy 16 assessment this summer with the plan -- the goal of having 17 a proposed rule out in January of next year, and the final

18 rule in October of 2014. 19 I want to note, as you are aware, that we 20 are not planning to do a second draft of the policy

21 assessment. As we noted in the cover letter that we sent 22 you, the cover memo, at this point we don't have any

23 substantive information that we would add that would 24 provide a basis to developing a second draft of the policy

25 assessment.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 162 1 And so this is the one draft that we're 2 planning, and we very much look forward to hearing your 3 comments on it today. And we appreciate the comments that 4 we've received so far and all the work that you've put in 5 to reviewing it. I will note that when issued the final 6 policy assessment, you are welcome to offer comments to us 7 on that if you wish. We won't be soliciting comments on 8 it. But if the CASAC panel has additional comments that 9 it wish to offer, we would certainly take those into 10 account as we move forward in the rulemaking.

11 And I'll also note that there have been 12 occasions where CASAC panels have provided comments to us 13 on our proposed rules. So I want to note that we're not 14 going to be soliciting comments in that way. But to the 15 extent the panel wish to provide additional comments, 16 there will be a couple of opportunities for that even 17 though we're not going to be providing a second draft of 18 the policy assessment to you. 19 So unless there are any questions, I'd like 20 to briefly -- yes? 21 DR. RABINOWITZ: Somebody asked me to ask 22 what was the budget for this? 23 MS. WEGMAN: I can't tell you right now 24 what the budget is for it, but we provided the resources 25 that we felt were needed for this review. And our primeMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 163 1 resource here are the people who have done the work at -- 2 you know, a standard team working on it. So I can't -- 3 DR. WASSERMAN: Great job.

4 MS. WEGMAN: That's what I think. I think 5 they've done a great job. Thank you. Any other 6 questions? 7 (No response.) 8 MS. WEGMAN: Okay. I'm then going to turn 9 it over to Dr. Murphy. And I think we've already -- I 10 guess the next slide --

11 DR. MURPHY: Yeah. In addition to the 12 people Lydia mentioned, there's also Dr. Halil Cakir in 13 the back as well, which is some of the air quality 14 analysis. If there's questions on that, he can answer

15 them. 16 So moving to the next slide. Who has

17 control of this?

18 MS. WEGMAN: You do. 19 DR. MURPHY: Oh. Sorry. Okay. This 20 morning there was mention to me that someone like to be 21 told what they were going to be told, so this slide is 22 giving you a heads up of what we will briefly cover in the 23 remaining slides. Just touching on the purpose and 24 description for the policy assessment, noting the history 25 and multimedia aspects associated to lead NAAQS andMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 164 1 summarizing the key considerations for the primary 2 standard. And Ginger Tennant will go through those for 3 the secondary standard and then just briefly touch on the 4 overview of the charge. 5 With regard to the policy assessment, the 6 policy assessment presents a staff evaluation and 7 conclusion on the policy implications of key scientific 8 and technical information. The draft policy assessment, 9 which you-all are reviewing, presents the preliminary

10 staff conclusions. 11 Importantly, the policy assessment helps to 12 bridge the gap between the scientific and technical 13 assessments presented in the ISA and REAs that are 14 considered in the review and the judgments that are 15 required by the EPA administrator in determining whether 16 it's appropriate to retain or revise the National Ambient 17 Air Quality Standards. 18 Development of the draft policy assessment 19 is also intended to facilitate CASAC advice to the agency 20 and recommendations to the administrator as provided for 21 in the Clean Air Act, and also to facilitate public input 22 and comment in the early phases of reading. 23 So just briefly, the National Ambient Air 24 Quality Standards for lead were initially set in 1978. 25 Most recently our review of the 1978 standard wasMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 165 1 completed in October of 2008. As a result of that review, 2 EPA concluded that the large body of evidence that had 3 been accumulated over that three-decade period called into 4 question the adequacy of the primary and secondary

5 standards. 6 With regard to the primary standard, EPA 7 concluded that it was not requisite to protect public 8 health with an adequate margin of safety as required by 9 the act. And we substantially revised the standard, 10 including the lowering of the level of by an order of 11 magnitude from 1.5 to 0.15 micrograms per deciliter. 12 With regard to the secondary standard, we 13 concluded that it needed substantial revision. However, 14 the relevant data were lacking to provide a basis for 15 setting a secondary standard independent -- of an 16 independent basis than that for the primary. And so it 17 was revised to be identical in all respects to the 18 primary.

19 The review of as a lead National Ambient 20 Air Quality Standards involves complexities that different 21 and unlike any of the other National Ambient Air Quality 22 Standards. The persistence of lead contributes to its 23 multimedia distributions throughout the environment and 24 throughout human exposure microenvironments. 25 Also, the persistence contributes to aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 166 1 tempo-complexity that in that lead that is emitted during 2 the time -- or has been emitted during the time prior to 3 regulation or during the time of more relaxed

4 recommendation has contributed to concentrations in the 5 environment and in human populations. That remains today 6 in the older generation of human populations. 7 And this complicates our consideration in 8 this review with regard to the adequacy of the now current 9 standard. And these figures was used in the policy 10 assessment to try to illustrate some of them. 11 When we go into the review, the originating 12 question that we begin with is: Does the currently 13 available scientific evidence and exposure risk-based 14 information support or call into question the adequacy of 15 the protection afforded by the current lead standard? And 16 we ask that, first, with regard to primary and then 17 secondary. 18 Traditionally, we turn, first, to

19 considerations of the evidence and then move on to 20 considerations of the exposure risk-based information in 21 thinking about that question. 22 In this review, the evidence available 23 since the last review continues to indicate neurocognitive 24 effects in young children as the most sensitive endpoint; 25 that blood lead is the most appropriate lead exposure/doseMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 167 1 indicator for health effects characterization; that air 2 lead contributes to lead in blood; and that air-to-blood

3 ratio -- estimates of air-to-blood ratio that have been 4 published or made available since the last review fall 5 within the ranges that were available at the time of the 6 previous review. 7 The risk factors that are recognized to 8 increase exposure or susceptibility to lead have been 9 recognized to include early childhood (including prenatal 10 life state), nutritional status, proximity to sources 11 (including residential factors) such as lead in housing 12 and some racial and ethnic backgrounds. 13 And then lastly, as in the last review, a 14 key role was played by epidemiological studies of blood 15 lead and also by studies that relate air concentrations to 16 lead in children's blood. And those will provide for 17 conclusions with regard to health effects of ambient air

18 lead. 19 Additionally, the limited newly available 20 evidence in this review on inputs to the evidence-based, 21 air-related IQ loss framework that was developed in the 22 last review are generally consistent with what was

23 available at that time. 24 The framework integrates two types of 25 relationships, relationships between air -- lead and airMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 168 1 and lead in children's blood and relationships between 2 lead in children's blood and their cognitive impact, their 3 IQ. And this framework was used in the last review to 4 consider the evidence, particularly with regard to the 5 subset of children that are most exposed to lead in the

6 air. 7 Previously identified uncertainties still 8 remain in this review. Those include those with regard to 9 the shape of the dose-response curve for neurocognitive 10 decrements or IQ of air-related lead in young children, 11 uncertainties with regard to air-to-blood ratios that 12 related lead and air to lead in children's blood, 13 particularly with regard to the steps that transfer lead 14 from air through the exposure pathways to lead in 15 children's blood under today's circumstances for exposure. 16 And there's also uncertainty with regard to 17 the role of current air lead exposures in contributing to 18 other health effects in other populations. 19 And moving on to risk-based considerations.

20 We draw the common results of the risk assessment that was 21 developed in the last review. This was completed in

22 November of 2007. So we'll refer to it as the 2007 REA in

23 the document. 24 And for considering risk associated with 25 the now current standard, we focused on results from thatMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 169 1 review from two different case studies, one which is 2 referred to as the generalized local urban case study. 3 And for that one we've performed an interpolation of 4 results that were initially -- of analyses that were 5 initially conducted for two air quality scenarios which 6 bracket those associated with the current standard. And, 7 also, there's a location specific urban case study for 8 which the conditions are comparable to the current

9 standards.

10 We concluded that the air-related risk 11 estimates from those two case studies are roughly 12 consistent with and generally supportive of the estimates

13 that are derived from the evidence-based framework. 14 The estimates are approximate. We 15 recognize them to be approximate and characterized by two 16 bounds, and upper bound and a lower bound. And we have 17 limitations in the ability to quantify air-related 18 exposure and risks. 19 This effect on the upper bound contributes 20 to the overestimation of that bound, particularly at lower

21 air concentrations. And that's a function of the methods

22 and data limitations in the risk assessment. 23 Uncertainties that were previously 24 identified with regard to the risk assessment still 25 remain, and including the uncertainty -- included that theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 170 1 uncertainty in air-related risk is greater in air quality

2 scenarios under lower air concentrations. 3 With regard to the preliminary staff 4 conclusions, we conclude that the current body of 5 evidence, in combination with the exposure/risk 6 information, supports the primary standard as protective

7 as the current standard. 8 Further, we've preliminarily concluded it 9 is appropriate to consider retaining the current standard, 10 including all its elements, without revision based on 11 consideration of the health effects evidence, including 12 particular emphasis on the evidence-based air-related IQ 13 loss framework. And the key aspects of this framework are

14 consistent with the evidence in the last review. 15 Also based on consideration of the exposure 16 risk information drawn from the 2007 REA, as supporting 17 information, along with its associated complexities and 18 limitations. And we consider reasonable judgments on 19 uncertainties in the evidence and exposure/risk, including 20 increased uncertainty at lower air levels, judgments on 21 public health implications of estimated air-related blood

22 lead and risk levels under the current standard and 23 judgments on the appreciable uncertainty as to whether 24 there would be reductions in the public health risk from

25 alternative lower standards.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 171 1 And with that, I'll turn it over to Ginger 2 for the secondary. 3 MS. TENNANT: Thank you. Okay. So this is 4 the question we're considering with regard to the 5 secondary standard in the policy assessment. And it's 6 essentially the same kind of question that you were asked 7 for the primary. Does the currently available scientific 8 evidence and exposure/risk-based information, as reflected 9 in the ISA and REA, support or call into question the 10 adequacy of the protection afforded by the current 11 secondary lead standard? 12 Okay. And so, again, similar to the 13 primary standard, we'll walk through the evidence-based 14 considerations, the risk-based considerations and then 15 into the preliminary staff conclusions. 16 Again, we have the evidence-based 17 conclusions. And this is just an overview of the main 18 evidence-based considerations that were presented in the 19 draft policy assessment that you're reviewing today.

20 The evidence available since the last 21 review continues to indicate that lead deposition to soils 22 has decreased since the phase-out of leaded on-road 23 gasoline; that bioavailable lead is a better predictor of 24 effect on organisms than the overall amount of lead in the 25 system; that lead has effects on growth, reproduction andMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 172 1 survival, and that these effects can be adverse to 2 organisms and ecosystems.

3 There continues to be limited evidence to 4 link, as we were discussing this morning, the current 5 ambient air lead emissions and deposition to environmental 6 media and then to ecological effects.

7 And the connection between the air 8 concentration and ecosystem exposure and associated 9 potential for welfare effects continues to be poorly

10 characterized and is more so for the conditions associated

11 with the current lower standards than had been the case 12 for the prior standard. 13 Okay. And so this is for the risk-based 14 considerations. So given the evaluation of the newly 15 available evidence, we concluded with case studies that 16 the available evidence didn't provide the basis for 17 developing new ecological risk and exposure assessments.

18 So what we've done is to characterize the 19 case studies presented in here, the 2006 pilot risk 20 assessment, which was the first draft of the REA. There 21 was later drafts that looked at the primary standard, but 22 this is the one that looked at the ecological standard.

23 So that's the difference between the 2006 and the 2007 24 that Deirdre was talking about.

25 And so what we've done here is look atMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 173 1 that. And to the extent to which those case studies were 2 part of the commissions that are associated within our now

3 current standard. 4 And so as you can see, the case study 5 results vary. The primary and secondary lead smelter case

6 studies are located in counties which exceed the current

7 standard. It's unknown whether the current air 8 concentrations at the near roadway case study sites exceed 9 the current standard, although the soil concentrations 10 include deposition that would be associated with higher 11 past concentrations, including usage of leaded gasoline. 12 In the Hubbard Brook Case Study, the 13 ambient air concentrations likely do not directly impact 14 the stream lead levels under air quality conditions 15 associated with meeting the current standard. And that

16 was the semi-conclusion that was reached in the last

17 review. 18 The extent to which the past (vs current)

19 air emissions of lead have contributed to surface water or

20 sediment concentrations at the locations identified in the

21 Nationwide Screen continues to remain unclear. 22 And so when considered with regard to 23 air-related ecosystem exposures likely to occur with air 24 lead levels that just meet the current standard, the risk 25 information does not provide evidence that the currentMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 174 1 standard is inadequate. 2 And so these are the preliminary staff 3 conclusions with regards to secondary standard. Currently

4 available evidence does not include evidence of 5 significant effects at lower concentrations or evidence of 6 higher level ecosystem effects beyond those reported in

7 the last review. 8 There are significant difficulties in 9 interpreting effects evidence from laboratory studies to 10 the natural environment and then linking those effects to

11 ambient air lead concentrations. No new critical loads

12 information is available that would inform our 13 interpretation of the public welfare significance of the 14 effects of lead in various ecosystems. 15 Therefore, the risk evidence does not call 16 into question the adequacy of the current standard, and

17 there is no new evidence to inform the consideration of a 18 distinct secondary standard. 19 Therefore, preliminary staff conclusion was 20 it's appropriate to consider retaining the current

21 standard without revision. 22 And now I'm going to hand it back to you. 23 DR. MURPHY: And I'll just touch briefly on 24 the areas of charge questions that's on the table contents 25 of the document as well. The first charge question isMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 175 1 with regard to introductory and background material which 2 are described in Chapter 1, and we're asking this 3 regarding to our characterization of the context and 4 background provided on past reviews and the scope for the

5 current review. 6 Then in Chapter 2 we ask the panel to

7 consider characterization of the most relevant information

8 -- whether or not we characterized the most relevant 9 information on emissions, air quality, lead concentrations 10 and other media and ambient lead monitoring information. 11 With regard to the primary standard, we 12 have two chapters, Chapter 3 and Chapter 4. Chapter 3 13 focuses on the health effects and exposure/risk 14 information. And we've asked this very charge questions 15 for comment on our characterization of key aspects of the 16 health effects evidence, including differences from the 17 last review and the characterization of quantitative 18 exposure/risk estimates, and associated limitations and 19 uncertainties, in a context of the current review. 20 And then lastly, with regard to the primary 21 in Chapter 4, the charge questions speak to the question 22 of our presentation of considerations informing the 23 preliminary conclusions, including focus on the 24 air-related, evidence-based, IQ loss framework. And we're 25 interested in hearing the panel views on the adequacy ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 176 1 the current standard, including all of these elements. 2 And with regard to the staff conclusion, that the current 3 standard is adequate without revision. 4 With regard to the secondary standard, we 5 have two chapters, Chapter 5 and Chapter 6. The focus is 6 on the welfare effects and exposure of risk information. 7 We're asking the panel's reviews with regard to our 8 characterization of key aspects of the welfare effects 9 evidence, including differences from the last review. And 10 with regard to our characterization of the quantitative 11 screening-level risk assessment and the associated

12 limitations and uncertainties now in context of the

13 current review. 14 And then Chapter 6, we have presented our 15 review of the secondary standard. And we're asking for 16 the panel's views on the presentation of considerations 17 which inform our preliminary conclusions and the panel 18 views on our conclusions with regard to adequacy of the 19 current secondary standard. 20 DR. FREY: Okay. Thank you. Are there 21 questions for clarification from members of the panel for 22 the Office of Air Quality and Standard? 23 (No response.) 24 DR. FREY: Okay. All right. Okay. Well, 25 thank you for the presentation. And I'm assuming you'llMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 177 1 be here if we have some questions from the discussions. 2 The next item on the agenda is public comment, which we 3 don't have any at this time. So then we proceed to the 4 subsequent agenda item, which would be panel discussion. 5 And we'll begin -- we'll go in order of the 6 chapters. We'll begin with Chapter 1. The lead 7 discussant is Dr. Davidson, and the other discussants are 8 Dr. Rabinowitz and Dr. von Lindern. So I'd like to give

9 the floor to Dr. Davidson. 10 DR. DAVIDSON: Okay. Thanks very much, 11 Chris. I want to say that I think this is a very, very -- 12 you did a very nice job on this policy assessment. And I 13 feel overall that that Chapter 1, there's a reasonably 14 good job in laying out the floor for the rest of the, the

15 rest of the document. 16 However, I have a couple of minor issues 17 that I don't need to go into here. They're written up. 18 But there's one major issue that I felt we want to bring 19 up. And that is the fact that lead really is unique in a 20 number of ways. It's unique in that of all the various 21 pollutants, we have disturbed the natural cycling of lead 22 to a greater extent than virtually any other pollutant. 23 And I think that was a point that should be made. 24 But in addition -- it's unique in that this 25 is really one of the biggest environmental success storiesMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 178 1 that exists for any pollutant. If you look at globally 2 what has happened with lead emissions and lead 3 concentrations, certainly the removal of lead from, from 4 gasoline in the United States was the beginning of the 5 removal of lead from gasoline in many other countries

6 around the world. 7 And so this really has had a tremendous 8 global impact. And I think it would be very difficult to 9 think of another pollutant that has had -- where people

10 have made a decision that has reduced the emissions to the 11 extent that we've done with lead for any other pollutant. 12 Probably the only, the only thing that really comes to 13 mind on a global stance is something like chloroformic

14 carbenes. 15 And, in fact, chloroformic carbenes -- I 16 mean, they are now new pollutants, to begin with. But, in 17 fact, eventually the reduction of chloroformic carbenes 18 will (unintelligible) what's happened to lead. 19 But for right now, lead is really a unique 20 success story. I think that's one thing we could all put 21 some credit into. Okay. But there's another unique, and 22 that's that as a result of a very large emissions lead 23 that occurred over such a long period of time in the U.S. 24 and around the world, lead also has the biggest legacy 25 problem of any pollutant. And it is that point that IMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 179 1 think is most important. 2 So the problem with lead that we face now

3 is not so much the reduction of current emissions as much 4 as it is understanding what happened to the millions of 5 tons -- and we are talking about loads of tons of lead 6 that were emitted in this country. And, in fact, we do 7 not have a good handle on where that lead went and what 8 the exposures are of that lead. 9 So I guess the bottom line point that I 10 would like to make is that I really think putting lead 11 into the proper context needs some statements about the 12 uniqueness of lead, these various points of affecting the 13 natural cycling. An enormous success story, but also a 14 very major legacy problem. And the fact is we don't know 15 today what happened to those millions of tons of lead, and

16 we don't know -- we don't have information on human 17 exposure to those millions of tons of lead. So that's -- 18 I would like to see that brought up in the introduction. 19 So that's all I wanted to say. 20 DR. FREY: Okay. Thank you. This will 21 open up a big discussion, but I guess is there a further 22 context in the legacy of lead in terms of re-entrainment 23 and (unintelligible) exposures in the (unintelligible) 24 that's worth discussion along with what you're commenting

25 on?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 180 1 DR. DAVIDSON: Well, I think that's an open 2 question. As you know, there have been papers and 3 literature about the importance of these cited lead, and 4 there is some disagreement about that importance. I think 5 that's part of the uncertainty. 6 DR. FREY: Okay. All right. Well, thank 7 you, Dr. Davidson. And let's see, next on the agenda is 8 Dr. Rabinowitz. Oh, I'm sorry. Did you have a comment on

9 this issue? 10 DR. WEITZMAN: I thought that was very 11 eloquent. I just wanted to voice my own concern in 12 tempering our enthusiasm about this as a success. 13 Catalytic converters played an enormous role in limiting 14 lead emissions. It wasn't necessarily -- lead being 15 removed from gasoline wasn't necessarily (unintelligible) 16 to protect the nation's children. 17 This is a multimedia exposure problem, and 18 we're here talking about ambient air. But the FDA and the 19 Consumer Products Safety Commission, part of the EPA, as 20 well as the medical community played a profoundly 21 important role in litigation, in eliminating paint -- lead 22 in paint. So I don't in any way mean to trivialize what I

23 have witnessed over the course of decades. 24 But it's taken partnering, and it's taken a 25 real vision about the ozone lap between environmentalMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 181 1 health and (unintelligible) agencies. Would you agree

2 with that? 3 DR. DAVIDSON: I would entirely. I think 4 your points are very well taken. 5 DR. FREY: Okay. Dr. Rabinowitz. 6 DR. RABINOWITZ: I agree with everything 7 said so far. What would I say about the documents 8 themselves? I must say I agree -- I like the overall 9 approach. I like the systematic approach. I recognize 10 the nature of it. The opinions suffer from frontal 11 phobia. I don't know if Chris's remarks about how nifty 12 lead is. (Unintelligible.) Further, if you just compare 13 the annual reduction rate of lead in tons, million tons, 14 and just divide it up by the average cost of the pints. 15 If you have any element, iron or copper, zinc, having any 16 element, lead stands way out. 17 If you do that with a simple division, you 18 get the average ton production is divided by the average 19 cost of the proposition. Lead is frighteningly different. 20 I happen to love lead because other (unintelligible)

21 elements in that there's a natural variation of a 22 composition of lead. 23 About this document, I have a few comments. 24 I think that -- just in general, I think that it does 25 adequately provide the reader a clear, stand-alone basisMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 182 1 to make a decision about whether to obtain a revised 2 understanding. I think you could read this without having 3 to go back to the earlier documents. 4 I think it adequately provides the reader a 5 clear basis, and I happen to -- maybe it's through the 6 emission. I happen to agree with you about maintaining 7 the current standards. Basically, if you -- even if you 8 lower the air lead standard to zero, you effectively 9 change blood lead level distribution. So you're not 10 getting the edge protection that we find in here, the 11 airport standard (unintelligible). 12 There are a few little points we could 13 change about it. Chapter 2, Line 28, you talk about the 14 values in the environment. And I think that somehow you 15 should say that these current values in the environment 16 are expected to decrease it for -- to be left on their 17 own. And the rest of my comments are in the written form. 18 Thank you. 19 DR. FREY: Thank you. Okay.

20 Dr. von Lindern. 21 DR. VON LINDERN: Well, I agree with most 22 of the comments that I have heard. I have a couple of

23 caveats. The first one would be I don't love lead. I 24 like lead and I respect lead, and I like it more than I 25 like gold. But that's about as far as I'll go on that.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 183 1 And I agree with Dr. Davidson, with one 2 caveat on that. As I go through this, generally I think 3 it's a good policy document. And I have to admit it 4 probably adequately addresses the question that's before 5 the agency. So most of my comments, again, are about what 6 the agency doesn't do as opposed to what it does do well. 7 But in the discussion, I do does overdo 8 that the conclusion that no information justifying 9 reconsideration of the NAAQS has come forward. I think 10 that's all I agree with that conclusion. I think there 11 should be caveats to convey the level of uncertainty and

12 lack of information that's involved in that decision. And 13 I don't think that gets conveyed in the policymakers, and 14 I don't think it also gets conveyed in this document how 15 limited the scope, its volume, the ISA is. 16 And that's limited because of the scope.

17 It was limited both in terms of the database that it 18 examined. It's limited in terms of the question that it 19 addresses. And the most important to me, it's limited in 20 terms of the geography that can be considered in 21 evaluating the policy. 22 I think there's also another aspect of this 23 new procedure that bothers me as well, and this looking 24 only at information that has accumulated in the last five 25 years without conveying how limited the previousMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 184 1 information was -- and that the fact that some of that 2 information we're relying on, in particular the areas that 3 I've complained about, are severely outdated. 4 And I hate to see a process come here that 5 every five years we can say, No new information has come 6 forward. We'll stick with what we've got when the basis 7 of that decision is deteriorating because information is 8 no longer applicable. 9 One example of that, I think, is the risk 10 assessment of 2006. I think we all recognized that the 11 word "risk assessment" was weak because they weren't 12 monitoring data. There weren't emissions data to really 13 update the risk assessment based on observation. It was 14 based on modeling. And the inputs of those models at that 15 time were 5, 10, 15, 20 years old. Now, we're still 16 relying on that same document this time around. I don't 17 see that conveyed to the policy readers. 18 I think all too often it says, No new 19 information has come forward, when sometimes it should 20 say, We didn't look for any new information, in some 21 areas. And there simply wasn't enough information before. 22 So the fact that there's not any now doesn't make it more 23 comforting.

24 That doesn't mean that the decision is 25 going to change, but I think it still should be conveyedMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 185 1 to the policy folks that what level of uncertainty goes 2 with -- with these various conclusions that are passed on 3 to them. One of the greatest areas of uncertainty, of 4 course, is in the production use and disposition of lead. 5 And I think Dr. Davidson did a good 6 presentation about the uniqueness of lead. There is 7 multimedia. The agency does a good job of recognizing 8 that. In fact, you've spent (unintelligible) analysis

9 over the last few decades and does do this multimedia 10 analysis. But it also -- its effects go beyond the 11 purview of the Clean Air Act or NAAQS. 12 So I've heard Dr. Frey say that we could 13 give recommendations regarding the effect this may have on 14 energy policy. I wonder if we can give a recommendation 15 on the effects it may have on places that are outside the 16 purview the National Ambient Air Quality Standard. 17 And one example I'd like to make is 18 Dr. Davidson does correctly, I think, point out that the 19 removal of gas in the additives in the U.S. have very 20 positive impacts globally. And United States is a leader 21 there. There was less lead emitted on this plant 22 (unintelligible) as a result of that. 23 But with respect to the production, 24 recycling the solo lead, we didn't curtail that globally.

25 We moved it out of the United States. So those emissionsMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 186 1 are still happening. They're having less control, and 2 they're damaging more children. 3 So it is a great success story, but as with 4 every other environmental success story there are 5 unintended consequences. And I think it's appropriate 6 that that should be considered in advance as part of the 7 policy. 8 If you can't look at it in terms of the way 9 you define the document -- the ISA document, it seems to 10 me certainly if you look at it in terms of how it might 11 affect the policy that this agency is putting forward. 12 Thank you. 13 DR. FREY: Okay. Great. Yes, Dr. Murphy. 14 DR. MURPHY: Sorry. I just wanted to 15 clarify. Dr. von Lindern, regarding your mention about

16 REA that it's -- the REA that's the human health risk

17 assessment was not based on decades old information. I 18 mean, there were both modeling and monitoring based case 19 studies. And the monitoring based ones were based on 20 fairly recent information. 21 I cannot remember the exact year, something 22 like 2003 to 2005, I think at that point. It was whatever 23 is most recently available. And the modeling was based on 24 the information we had on emissions at those two point 25 sources that were included. So just as a clarification.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 187 1 DR. VON LINDERN: Yeah. I wouldn't 2 disagree with that, but most of those emission trackers go 3 back to the 1970s that were used. The monitoring network 4 was severely curtailed in the 1990s, and there was very 5 little -- relatively very little information available to 6 relay at that time. And I think that's why we all see it 7 as a modeling effort. I mean, you-all did a great job of 8 that, but it would have been better to have based that on 9 monitoring and evaluation of real exposure as opposed to 10 modeling exposure. And it's just a little bit 11 (unintelligible) now -- that was outdated at that time, 12 and now it's five years older. The next time we're here 13 it's going to be ten years older. And there's not 14 information being collected to update that. So... 15 DR. FREY: Well, I guess your comments 16 touch on a couple of things -- and, obviously, you alluded

17 to. And I have reviewed the charter of CASAC at the 18 beginning of the meeting. And I think there's at least 19 two things that are relevant. 20 One is, you know, what is the research 21 effort necessary to provide the required information. So 22 that's definitely something we can advise the 23 administrator on. So if there's something that the panel 24 wants to say about the need to collect data to support 25 exposure and risk assessments going forward, we certainlyMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 188 1 can say that. 2 And secondly, as I mentioned, part of our 3 charter is to advise the administrator on adverse public 4 health, welfare, social economic or energy effects which 5 may result from various strategies for attainment and

6 maintenance of standards. 7 It doesn't say -- this language here 8 doesn't say public health effects (unintelligible). Maybe 9 that's an intent, but it doesn't actually say that. So I 10 think if the panel wanted to make a statement to the 11 administrator to raise awareness of, you know, the 12 potential -- as you say, either unintended consequences 13 or, you the -- you know, sort of -- well, we solved the 14 problem here (unintelligible). 15 I think we -- initially in our charter, and 16 my interpretation that we could do that. 17 DR. VON LINDERN: Okay. Good. And I, and 18 I agree that we can -- I think it's worth mentioning. 19 DR. FREY: Okay. 20 DR. KOSNETT: I agree. And it is worth 21 mentioning. One of the consequences of the air pollution 22 control technology that's been worked there on the COB 23 issues of lead in the United States, which is 24 (unintelligible). It is resulting in the -- in a lot more 25 of that recycling and getting exported to Mexico.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 189 1 DR. FREY: Yeah. And the one thing I think 2 we have to, I guess, be mindful of is a lot of our advice 3 is based on a fairly detailed review of evidence -- you 4 know, for example, the size, you know, prompted ISA at 5 times. So I think any statements we make -- I guess there 6 should be, you know, some evidence that we're comfortable 7 with to support that so that there are citations or -- and 8 this will probably come into, you know, written document 9 of these public comments, but I would encourage that as 10 well. I know George and then Rich. 11 MR. ALLEN: Just kind of a quick update. 12 Actually, we are fairly data rich in terms of lead 13 monitoring now. At one point (unintelligible), but I just 14 wanted both source monitoring and population monitoring -- 15 lead monitoring is a substantial network, multiple 16 networks. A pretty good, pretty rich data set to let us 17 know what's out there. So in light of that, early 2000's 18 we were in much better shape. 19 DR. VON LINDERN: And I agree. That's a 20 pretty good picture. And as I think I said this morning, 21 it's really a question on my three sources. In terms of 22 other things you can spend money on, and it's probably 23 appropriate where it's at. 24 I probably didn't do a good job in -- also 25 supporting one of Dr. Davidson's points in that lead isMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 190 1 unique and that is multimedia, and there is a real legacy 2 problem there in terms of the zincs. But that's not just 3 a historical problem. That's an ongoing problem. There 4 is still just as much lead being used in the U.S. right 5 now that's ending up in the sub city. And I don't think 6 we know where those cities are, and I think it's incumbent 7 on -- somewhere in the agency probably to do that. 8 And then Dr. Weitzman also did a very 9 excellent job in giving many others credit for this -- 10 resolving this problems in the U.S. Many other agencies 11 were involved and many other players and actors and 12 factors. And then you have a little historical note on 13 that, and I agree. And my historical observation would be 14 that there -- there seems to be less collaboration among 15 the different regulators now than there were earlier in 16 the lead times. We used to have other agencies here, and 17 they were all working in a lead regulation world.

18 But we seem now to be almost limited to the 19 indicator or averaging foreman level of NAAQS. I don't 20 know that that focusing on emission to that point from 21 what was doing 30 years ago is in the best interest 22 (unintelligible) of the country. 23 DR. FREY: Okay. Thank you. Rich? 24 DR. CANFIELD: Two questions. One is -- 25 you spoke about the need or the desirability for havingMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 191 1 evidence for issues like distribution of lead and other 2 offshore and recycling. I would think it would be okay 3 for us to express concern about the general lack of 4 information, and I don't -- I don't -- I mean, other 5 people may know better than, but that includes you and it 6 does exist. So I don't want us to put a standard that we 7 can't meet for something that can be very important. 8 DR. FREY: Yeah. And if could, I think you 9 raise an excellent point. And what I might want to say -- 10 I think if we're going to say that NAAQS is going from 11 U.S. to Mexico -- if we're going to make an assertion, we 12 probably need to back that up. But if we're going to just 13 comment on, you know, here's important information that we 14 think should be obtained, then this is sort of like almost 15 a research need or a need for a future setting. And, of 16 course, then the burden's not on us to provide the

17 evidence.

18 DR. KOSNETT: Yeah. It doesn't have to be 19 a huge -- 20 DR. FREY: Yeah. No, no. 21 DR. KOSNETT: But for example, there have 22 been usage meetings between the United States and NAAQS 23 where they're always talking about, you know, you travel

24 with lead in the United States. So there's some 25 importance.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 192 1 DR. FREY: Sure. Yeah. 2 DR. KOSNETT: I think he explained his -- 3 you know, certainly, there's a lot of lead. And lead is 4 more recycling lead. So we're using a lot of lead in 5 recycling. 6 DR. CANFIELD: There are a couple of others 7 that are high.

8 DR. KOSNETT: What? 9 DR. CANFIELD: There are a couple of others 10 that are very high. 11 (WHEREIN, unintelligible due to multiple 12 people speaking at once.) 13 DR. CANFIELD: Again, this is outside of my 14 area of expertise. On one hand we have people presenting 15 information about the air monitoring technique and the

16 idea that the data is close to useless. The monitors 17 aren't parallel. They don't get anything; they're not in 18 the right places, et cetera.

19 But then at other times it's characterized 20 as quite good. So I understand one of my main concerns is 21 to have a really good sense of (unintelligible). Really 22 the quality of that air monitoring data, how good is it

23 now. Or do we -- don't -- do we need better air 24 monitoring? Is that really important. And is it worth 25 monitoring with the equipment that we have.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 193 1 DR. FREY: Yeah. Well, that's a great set 2 of questions. And, obviously, you're more informed to 3 answer it than I am, but I guess I'll kind of summarize. 4 So I think -- you know, almost with any 5 area, if you know more about it, you know more about the 6 skeletons in the closet and the limitations. And you know 7 a little bit more about monitoring of lead with a 8 (unintelligible) sampler. 9 And we had a presentation on this in the 10 last meeting about what's sensitive to things like wind 11 speed and wind direction, so that's probably not the best

12 method. And then we had some discussion earlier about 13 particle size and how that relates to exposure. So I 14 think one way of looking at this -- there's certainly many 15 opportunities to improve the techniques applied for 16 monitoring and to deploy better monitoring methods. 17 But there's almost a flipside to that too, 18 which is that, Well, operationally those will give us a 19 new definition of what it is that we're going to use as an 20 indicator, assuming that maybe some future standard would 21 be based on an improved -- you know, higher particle size

22 cut off or a different kind of TSP monitor.

23 And so then there's -- also I think the 24 question, the consistency in the time series of data that 25 we wouldn't actually be able to compare very well the timeMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 194 1 sequence of data from this new monitoring technology with 2 the old monitoring technology because they're 3 operationally different. So there are all these nuances

4 to do it. 5 But I think in terms of, you know, is the 6 current information completely useless, you know, 7 Dr. Hopke used the phrase earlier "reproducibly wrong." 8 And I don't know, maybe I should let you comment on is it 9 completely useless.

10 DR. HOPKE: That's what makes me nervous.

11 DR. FREY: Yeah. 12 DR. HOPKE: Not completely useless, but -- 13 you know, again, the technology has moved on. So the 14 question is, you know, at this stage where we ask for good 15 control, is it good enough for this purpose, or is this a 16 scenario where we have relatively limited resources to 17 develop monitoring tools. 18 Is this the place that is important enough 19 to focus that kind of attention? Probably not at this 20 stage, as we -- as we control things better and better, 21 particularly if we can get access to these last major 22 sources, is -- you know, is -- you know, is it good enough 23 for government work? 24 You know, we've got a pretty good idea of 25 the, of the response exposures with the exposures that weMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 195 1 have. We have that and used that to move things in the 2 right direction, seeing less clinical examples of lead 3 poisoning and problems like that. So, you know, at this 4 stage, is this the place where we're going to focus enough 5 attention to divert significant resources. I would say 6 probably not. 7 DR. CANFIELD: I guess that agrees with the 8 (unintelligible). What don't we know that we don't know. 9 You know, that's, I guess, the basis of my -- if we 10 listen, all this lead is coming in. We don't know where 11 it's going and we can't measure it. 12 (WHEREIN, unintelligible due to multiple 13 people speaking at once.) 14 DR. FREY: Yeah. Another phrase of today 15 is -- you know, is it adequate for its intended purpose.

16 DR. CANFIELD: Sure. 17 DR. FREY: I mean, maybe one could argue 18 that the high volume TSP samplers are, in some way, 19 adequate for the intended purpose. But I think, you know, 20 things could be improved. But then if you step back to an 21 even bigger picture (unintelligible), it's less of a 22 priority than something else. 23 I do want to comment on the good enough for 24 government work comment because when I -- my first job out 25 of high school I worked as a lab assistant at the NavalMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 196 1 Research Lab. And there were two post-docs in my lab. 2 And my father was -- worked for the government also. And 3 I used that phrase with the post-docs, and they repeated 4 it to the section chief. And he chewed them out for it,

5 so... 6 (WHEREIN, unintelligible due to multiple 7 people speaking at once.) 8 MR. YEOW: Technically, you guys are 9 special government employees. 10 MR. ALLEN: (Unintelligible.) 11 DR. FREY: Yeah. Yeah. We certainly 12 wouldn't start today with a high-volume sampler that's in

13 use now. 14 DR. HOPKE: And, again, it may be in the 15 context that would go under NAAQS kind of problem that you 16 develop a sampler that could do a better job for lead, but 17 also for (unintelligible) you're interested in monitoring 18 that have problems through both inculcation and deposition 19 and the passage within the GI. And now it may be worth 20 the investment because you're going to use it for more 21 purposes. 22 DR. FREY: All right. Lydia, do you want 23 to add something? 24 MS. WEGMAN: Well, I just wanted to note 25 that we do have two of our monitoring experts here, KevinMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 197 1 Cavender and Lou Weinstock. And to the extent that it 2 would be useful to the committee to hear from the experts 3 as to where we are in lead monitoring, we'd be happy to 4 have them speak to it. 5 DR. FREY: Okay. Okay. Well, let's see if 6 maybe that -- I don't know that we need that right now, 7 but if that comes up -- yeah. Dr. von Lindern. 8 DR. VON LINDERN: I think maybe I started 9 this, so I'm going to have to bring it back. My primary 10 point was -- and now I'm not sure I know the answer. We

11 didn't do it in the REA -- did we not do it because there

12 were no new data? Or did we examine some data that told

13 us that the situation was still the same? I think it's 14 because -- at least when I agreed that we shouldn't do it 15 was because I thought it defeats the purpose because there

16 wasn't new information accumulated at that time. 17 DR. FREY: Well, yeah, I think -- yeah, 18 that's a -- I think that's a good point. And I think in 19 some of the written comments this comes through. And I'm 20 assuming this will come through in our discussion today 21 is, yeah, there's a question. Is it because nothing's 22 changed or has there been some accumulation of evidence 23 that increases the confidence in previous decision. And 24 those are slightly different. But, yeah, Dr. Murphy. 25 DR. MURPHY: I was just going to clarify.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 198 1 With regard to the decision on the risk assessment, when 2 we develop an REA planning document, what we did was go 3 through the evidence that had accumulated and ask the 4 question: Was there additional evidence which would have

5 modified how we conducted the risk assessment such that

6 that new evidence warranted us to redo a risk assessment

7 with new information.

8 When we talked about information and 9 evidence, we weren't focused on monitoring information, 10 per se. And I don't think we considered much about the 11 availability of monitoring information other than I will 12 recall with regard to do we have more detailed monitoring 13 information in terms of gradients, because the issue of 14 spatial gradients was something we didn't understand in

15 the last review.

16 So -- but when we evaluated the information

17 available and made a decision that it did not warrant the 18 comment of a new assessment, it was because we would be 19 using the same models. We would be feeding them with 20 similar input. We would not be using substantially 21 different approaches which would give us a substantially 22 different answer. It wasn't focused on monitoring data, 23 per se. 24 DR. FREY: Okay. Other comments on Chapter

25 1?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 199 1 (No response.) 2 DR. FREY: Cliff, as the lead discussant 3 for Chapter 1, do you have any other requests or input 4 from the panel?

5 DR. DAVIDSON: No. I think I have it. 6 DR. FREY: Okay. Very good. Okay. Let's, 7 let's go to Chapter 2. Chapter 2 is Ambient Air Lead. 8 George Allen and Phil Hopke are discussants, and Rich

9 Poirot is the lead discussant. So I will leave the floor

10 to Rich Poirot. 11 MR. POIROT: Thanks, Chris. So I guess the 12 two -- Chapter 2 charge questions: To what extent does 13 the panel agree that the most relevant information on 14 emissions, air quality and lead concentrations in other 15 media is presented, and to what extent is the information 16 presented appropriately characterized and clearly

17 communicated? 18 In my opinion, yes, to all of the above 19 with just some minor suggested tweaks or suggestions. 20 Regarding the information on emissions, I think you've 21 done a really nice job -- and this is, by the way, a huge 22 improvement over the confusion over emissions that I 23 recall from the last lead cycle where it really wasn't 24 clear, you know, who was in first and who was in second 25 and that sort of thing.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 200 1 So I note -- you know, up through the 2008 2 NEI inventory data. So just a one general suggestion, 3 there's -- in describing it, since we're now in 2013, why 4 not just past tense, especially since you comment on a 5 number of occasions that there are a number of programs 6 that have already taken place or they're well on their 7 way. They're pushing emissions down or along those lines. 8 There's a very nice appendix that's added 9 that lists all the various regulatory programs. They're 10 already in the works. They're further pushing emissions 11 down. So I'm just thinking -- I don't know if it's 12 possible, but with a future version, the next draft of 13 this final version, any opportunity to get all 14 quantitative about some of those programs in place would 15 be very interesting information. 16 Or even, to me, a general characterization 17 of the kinds of emissions reductions we expect to see. Is 18 it likely to resolve them -- a reduced concentration away 19 from specific kinds of relatively few point sources. 20 That's one kind of reduction. Or if, for example, we 21 really were to get the lead out of av-gas or some other 22 largely dispersed forms of lead, would it be likely to 23 bring down the general population exposures everywhere.

24 And that would be another kind of concern. If that were 25 possible, it might be useful information to include.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 201 1 Along similar lines, the information that 2 you present under concentrations up through 2011, again, 3 it's very clearly presented. And I think you've done a 4 good job of that. However, as Rich pointed out, you know, 5 we've got a bunch of new source specific, including 6 airport specific monitors that have gone out at various 7 dates in the past from which some data is coming in. And 8 certainly if the airport would relay the sampling, it 9 would be hugely useful to inform not only this process, 10 but of course the parallel Section 231 process. 11 So, you know, with lead, since it's a not 12 to be exceeded standard -- and you can really know if you

13 have a violation with as few as three months of data. And 14 even if you don't have a violation, that kind of 15 information would be informative even if you don't have 16 three years of data that you use to calculate the design

17 data. 18 So maybe in the next version of this policy 19 assessment document -- or even as a -- something in 20 attachment to it, if you could bring any of that new data 21 forward and display it, I think it would inform the

22 decision. 23 By the way, somewhat of an aside, but this 24 parallel Section 231, the process on av-gas is kind of an 25 interesting thing. I got to wondering what happens if theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 202 1 data comes in -- and maybe you can help us with this. If 2 the data comes in and we have exceeded this near airports, 3 will it be possible for the agency to find that, no, it 4 doesn't pose a significant risk to health? 5 DR. KOSNETT: Can you give a -- just say a

6 word about what is the section -- what is 231? 7 MR. POIROT: Well, maybe --

8 UNIDENTIFIED SPEAKER: Marion back there 9 would probably be the best to speak.

10 DR. HOYER: 231 -- 11 DR. FREY: Could you use a microphone? 12 UNIDENTIFIED SPEAKER: Marion, why don't 13 you come up here. 14 DR. MURPHY: This is Dr. Marion Hoyer from 15 our Office of Transportation and Air Quality, and she's in 16 the middle of that process. 17 DR. HOYER: Section 231 is the part of the 18 Clean Air Act that gives us authority to evaluate 19 emissions from aircraft engines that cause or contribute 20 to air pollution. It could be reasonably anticipated to 21 endanger public health and welfare, and it gives us the 22 authority to set additional standards for pollutants that 23 we have test. But just to be clear, EPA does not have the 24 authority to set fuel standards for aircraft.

25 MR. POIROT: So -- and it's described inMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 203 1 the document as sort of this parallel separate unknown 2 process. But what struck me is sort of interesting as 3 having these two balls in the air at the same time. And 4 wouldn't it be interesting if there were exceedances of 5 the standard measured near airports, exceedances of NAAQS 6 -- it would be very difficult -- it would take a really 7 good lawyer to say, No, this doesn't constitute a 8 significant risk to human health. 9 Or maybe the other part of that that could 10 be really interesting is, Okay, what if the measurements 11 come down below the level of the NAAQS, could the agency 12 still then conclude, Yes, this does (unintelligible) lower 13 than the NAAQS. Just the relationship of those things, I 14 just wanted to comment was interesting to me. 15 I guess the information -- I thought the 16 information on -- well, as I said, if it were possible to 17 bring some of the new monitoring data forward, even if 18 it's not a full three years, if might be informative -- if 19 it's possible to do in the next version of this. 20 Then the last part of the charge question 21 related to the, the information on lead in other media. 22 And I guess my -- I had made this comment earlier, but I 23 thought a little bit more information on the 24 characteristics of lead in dust and what we mean by dust. 25 I'm especially interested in knowingMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 204 1 particle size characteristics of this dust that becomes 2 ingested. Because to me that's really where the energy

3 occurs between how do we -- how should we measure -- or do 4 we measure lead in the air, or should it be measured in 5 terms of the particle size characteristics versus what I 6 think of as the different particle size characteristics in 7 the dust that gets deposited on things that gets ingested. 8 Two are not the same in understanding the 9 similarities and overlapping differences would be an 10 important subject. So that was my, my -- those are my 11 general comments on the first question. 12 And then the second charge question, 13 information on ambient lead monitoring, I sort of answered 14 part of that. Oh, this is on monitoring methods more, I 15 think, the second charge question. That's right. 16 And I just noticed, for example, that the 17 agency expects to have a new improved sampler available 18 for consideration in a future review. So my goal would be 19 to get that A changed to B in the next review, rather than 20 just saying, Yeah, we're interested in this, kicking it 21 down the road, kind of like we did last time EPA was 22 interested in an improved and alternative sampler. So I 23 know it's a hard thing to make a commitment, but that 24 would be kind of a direction I would like to encourage you 25 to move in rather than having this maybe (unintelligible).Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 205 1 You know, although it still points out, 2 there's other things to do with money. It's just not the 3 best use. I kind of think it's something better than the 4 hi-vol is within our very near-term grasp. Although, 5 Chris, I thought, made one of the best points is, Man, 6 (unintelligible) historical record that's part of that 7 long-term success story. So certainly if the long-term 8 KSD sites, you don't want to switch to something 9 (unintelligible) for historical purposes. We'll keep a

10 few of these old records around. 11 So, again, towards that goal of moving 12 forward. I thought that was good language in the ISA that

13 made a clear and marketable distinction between the 14 desired characteristics for the sampling in the ambient 15 air versus the particle sizes and other factors pertaining 16 to dust deposited and ingested by non-breathing 17 techniques. So bringing a little bit more of that 18 information forward, I thought would be useful. 19 I'll restate my point about imprecise 20 language. We use TSP to mean whatever is convenient. You 21 know, tell me I'm wrong. I'll say, Oh, I didn't meant 22 that. You know, by the way, while others express concerns 23 about the monitoring and so forth. Look back in the ISA. 24 There's a graphic that shows the particle cut size 25 characteristics of the hi-vol sampler.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 206 1 And if you look at what's 50 percent 2 particle cut size, and this happened to be at 5 meters 3 (unintelligible). The particle cut size for the TSP 4 hi-vol, based in that chart in the ISA, ranged from about

5 12 to 18 microns. 12 -- and the difference between 12 and 6 18 was which way did you have the chip roof slanted in 7 respect to the wind. 8 So we're talking about 15 to 20 -- 15, 9 George mentioned, would be close to the upper limit of 10 what's theoretically possible. Keep in mind, what we've 11 already got is 12 to 18. You don't know which. You know, 12 maybe we should -- if we're going to continue to use TSP 13 sampling, why not specify the direction that you want the 14 wood slanted, the roof slanted in relationship to the 15 source. Because if you don't, you can deem the thing 16 about the difference between a cut size of 12 and 18. So, 17 anyway, that's all I had to say about specifically the 18 charge questions. 19 Maybe one other kind of minor -- I 20 questioned -- really, more of a question was -- on Page 21 228. And some of the associated graphics, you talk about 22 a category previously historical methods. But monitoring, 23 so I didn't quite know exactly what that was. And I was 24 guessing. Is this site where it used to be an active 25 source, the source is now shut down.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 207 1 And that category comes out to be kind of 2 the second highest category among all of your categories, 3 which is sort of interesting to me because, okay, the 4 source is shut down. Where is the lead coming from? 5 Presumably it's some sort of fugitive resuspension kind of 6 a thing. I don't know what else to infer there. So 7 that's kind of interesting. 8 And, you know, some of those sites seem to 9 be approaching, you know, closer levels to NAAQS. 10 MR. CAVENDER: With my experience in 11 secondary lead smelting, I would say just because the 12 source stops operating, doesn't mean that they uncover 13 their storage piles or do anything else. There still can 14 be quite a bit of -- due to the dust coming off of these 15 old industrial sites. We've got -- for the most part, 16 that's what we're seeing. There's a couple of sites that 17 we're seeing. We've got years of data, and we can see it 18 trails off at the top. But, yeah, we specifically want to

19 look at those to see if there's some other areas that we 20 should be looking at. 21 MR. POIROT: So, anyway, those were my just 22 general comments. I overall thought that this is really 23 well done. It doesn't need much -- just a tweak in the 24 directions in which I included in my written panel notes. 25 DR. FREY: Okay. Thank you, Rich. George.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 208 1 MR. ALLEN: Well, I concur with Rich. Just 2 a word (unintelligible). 98 percent of it is good enough. 3 It's only when you're close to large point sources where 4 you might establish that in a meaningful way. At the same 5 time, our mentions of lead are being used precise of any 6 of the NAAQS. We worry about 7 percent. Okay. 7 (Unintelligible.) I understand that. It's important, I'm 8 sure. But I want to put this whole process in perspective 9 to the NAAQS. I know it's important. 10 Overall, Chapter 2, it's a very good 11 summary. It's a well-organized summary. I had one 12 question on Section 2.2.2. The boxplots needed to have

13 the whisker defined. I didn't know whether the whisker 14 was 95th, but that's a minor point. 15 On the second charge question, Section 16 2.2.1, again, that's a well-written description of the 17 process being taken towards a better FRM sampler. And 18 other than that, my comments are pretty much the same as 19 the ISA. So I won't beat that horse anymore. 20 One slight oddity, which gets back to the 21 form of this thing, Page 2-22, Section 2.2.1.3.3. Is the 22 NAAQS form is unique. The lead NAAQS is unique to any 23 other NAAQS, never to be exceeded. So I have a question. 24 It talks about design values. And so how, how do you 25 calculate a design value for lead. Well, it turns out IMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 209 1 answered my own question. And the answer is it's 38 2 values for each of the purposes at the average of 3 one-month's peak. And you are running sort of average of 4 the highest of those as was the second value. 5 It might be useful to have that in the 6 document. I have no idea how it was done, and I had to 7 ask. I mean, I'm sure it's out there in the documents

8 somewhere. And that's it for me.

9 DR. FREY: Yeah. I think that was in 10 2.2.1.3.1. Thanks, George. Phil. 11 DR. HOPKE: Okay. Again, I agree that this 12 is nicely written. It brings on the Chapter 3 stuff into

13 what -- into the PA. One source that I think that's been 14 potentially neglected is the potential for burning old 15 wood. In a recent study that George and I were involved 16 with, we did see some hints that place wood is being made 17 into pellets. And both treated wood and obviously old 18 painted, lead-painted wood. 19 And given the current amount of waste wood 20 that would be generated in the north of New Jersey where 21 it is considered -- in older houses that very well contain 22 lead paint. One's concerned that a lot of that wood would 23 end up in chips and pellets. You know, again, it's not -- 24 it may not -- it may be a very localized source, but it 25 could be important to those locales.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 210 1 My big quibble here is the lack of any

2 basis for the form of the standard. There is no 3 literature cited for the not to be expected form of the 4 standard. As George indicated, it represents a problem in 5 terms of defining a design value. There -- you know, in

6 the other standards we've all had at least some literature 7 on things like the percentile for lead standard and other 8 kinds of bases for reviews that perform. 9 Here there's absolutely nothing, none -- 10 you know, the document is totally silent on where they 11 pulled this out of the hat. Now, it dates back to, you 12 know, primeval times when we were all young. But it would 13 be good to see some of that material (unintelligible). It 14 needs to be reviewed and recognized that we thought about 15 it again because the point of the standard is very 16 important. The combination of the concentration of the 17 form is completely what makes things happen. And 18 recognizing that the real world is units of distributions 19 and not in absolute values is really sort of essential to 20 making things work well. 21 And right now we have this 1970s primitive 22 view of things where we can set this never to be exceeded 23 in that criteria, and I think that it deserves at least a 24 short revisit to bring back what the basis was for setting 25 that in the first place. And there be some justificationMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 211 1 for why it's still pertinent today. 2 DR. FREY: Okay. Thank you. Rich. 3 MR. POIROT: I'd like to agree with Phil 4 and George on that point. However, I'd like to ask the

5 chair whether he thinks that that -- our comments on 6 Chapter 2 are the right place in the document to put that

7 in? 8 (WHEREIN, unintelligible due to multiple 9 people speaking at once.) 10 DR. FREY: Well, I think certainly for our 11 discussion, we've discussed it now and also tied it in 12 later. I think Chapter 4 actually deals with the form. 13 So we definitely want to make sure in our written comments 14 to the administrator that we convey information relative 15 to the form. Perhaps, in both places, if it makes sense. 16 Definitely we can combine it into the Chapter 4 17 discussion, if that seems to be the best place for it. 18 But I think at this stage having the discussions and 19 certainly -- 20 (WHEREIN, unintelligible due to multiple 21 people speaking at once.)

22 MR. POIROT: Yeah. No. I -- I didn't want 23 to cut it off in the session, is all. It's just that 24 question -- in the one place I could think of, maybe, to 25 put it into this Chapter 2 response is in terms of theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 212 1 presentation of available data. Let's present it, for the 2 most part, as homeland data where there are at least three 3 years available to calculate this design value, even 4 though it is not to be exceeded. You could get an 5 exceedance with (unintelligible). In reflecting on that, 6 it could -- go ahead and make a comment. 7 DR. FREY: Yeah. So I guess in terms of 8 our procedure, Deborah is the lead discussant on Chapter 4 9 -- do I have that right?

10 DR. CORY-SLECHTA: Yes. 11 DR. FREY: So, perhaps, Rich is the lead 12 discussant on Chapter 2 and Deborah on Chapter 4. You 13 want to make sure that -- well, we don't miss it. You 14 know, think all of the other ones did it and then no one

15 does it. But -- and then if there's some reason to have 16 it in both places, because there's some difference in the 17 context, that's certainly fine, in my opinion. 18 DR. MURPHY: Can I just clarify that the 19 data in three years are not required. It's three months 20 that makes a three-month average. And so there's an 21 appendix that describes the criteria for the air-quality 22 analyses and what the requirements were for the averages 23 of that audit graphed in those figures. So just to 24 clarify that point.

25 DR. FREY: Yeah. So it's a three-monthMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 213 1 rolling average. 2 DR. MURPHY: Right. So it's three months. 3 You need three monthly averages to derive a three-month 4 average. So it's not a three-year requirement for data. 5 Now, I think there's some confusion because in order to 6 judge an area to be in attainment with this number, you 7 need to have a clean three years, if you will. But to be 8 judged out of attainment, three months will serve. 9 MR. POIROT: Okay. And it was only data, 10 however, from sites to add three years of data and present

11 it. 12 DR. MURPHY: I'm sorry? 13 MR. POIROT: In the appendix, it summarizes 14 the available lead monitoring data. I believe you only 15 presented data from sites that had three years of data. 16 DR. MURPHY: I'm not positive on that, but

17 I don't believe that's the case.

18 MR. POIROT: Oh.

19 DR. MURPHY: But we can check that and be 20 clear on that point. That's a good comment.

21 DR. FREY: That sounds familiar. 22 MR. POIROT: That's why I inferred if three 23 years were necessary for the design guidance. And maybe I

24 misread it. 25 DR. FREY: Okay. Michael.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 214 1 DR. WEITZMAN: I don't mean to distract, 2 but I want to go back to something that Mr. Poirot said 3 earlier about dust lead. Given the past ten years

4 accumulated data about some of its serious effects at 5 lower levels of exposure in children, and the new CDC

6 statement. Is there a reason to revisit dust lead

7 standards. Does HUD do that or the EPA? And if it's the 8 EPA, is this the right panel? Did that make sense at all? 9 DR. CAVENDER: It is being looked at by 10 another EPA panel, and EPA is developing -- or relooking 11 at the lead -- resident, both the resident and commercial 12 buildings. 13 (WHEREIN, unintelligible due to multiple 14 people speaking at once.) 15 DR. FREY: Okay. Other discussion on 16 Chapter 2? Michael. 17 DR. KOSNETT: I had a question that relates

18 to both lead and the contribution of ambient air lead to 19 lead in soil. Yeah, lead in soil and lead in die. It's 20 addressed -- you know, there's a section on Page 2-27 -- 21 no, 2-36 that talks about lead in soil. And then it says 22 at the top of Page 2-37, Few studies have investigated 23 temporal trends of surface soil lead concentrations in 24 more populated areas in relation to reductions in usage of 25 leaded gasoline and paint.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 215 1 And I've also considered in relation to the

2 decrease of ambient -- airborne air related emissions. 3 Really, there's -- there's nothing really cited in here 4 that points to that. I know we talked about this when we 5 talked about the REA in 2001, but maybe the other people 6 -- I just wanted to speak to that. Do we really not have 7 any data that says what happens to all the lead in the 8 soil that's been deposited over time? 9 In urban -- you know, in urban areas -- you 10 have a thing in the previous paragraph about lead in 11 forests, and that's going down. You say, Well, maybe 12 because it's moving or something (unintelligible). The 13 question is about lead in soil that's just been -- not 14 contained, but in historical emissions it's just sitting 15 there. Do you know what happens to that? The assumption 16 is in your simulations -- do you keep that level, it's not 17 going to change? 18 DR. MURPHY: So I'm assuming you're asking 19 a couple of questions. I'm sorry. I'm hesitant. I guess 20 I could clarify a couple of things. This paragraph is 21 referring to -- as you know, the prior paragraph talks

22 about there are studies that relate trends in soil lead

23 concentrations in the remote areas and we tie them to 24 reductions in the use of lead gasoline. 25 In more populated areas, there are a fewMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 216 1 studies which do that in any way. And this then points to 2 the ISA for analyses that are presented in the ISA that 3 are close to that point but don't really present studies 4 that do that. So that's why the statements -- a few 5 studies have investigated because United States doesn't 6 really identify it as a limited data set. 7 Your second question seems to be having 8 something to do with the risk and exposure assessment, 9 which is a different thing. I mean, this is commenting 10 with regard to over this time period when we've seen such

11 dramatic reductions in air concentrations that have been

12 noted in the discussion earlier this afternoon. Have we

13 also tracked reductions in the soil concentrations in 14 urban areas. And this statement really just says a few

15 studies needed to have done that. And to the extent the 16 panel knows about other studies that should be cited, that 17 is something that would be useful to the ISA or could help 18 us if they were already (unintelligible). 19 DR. KOSNETT: My second question, you know, 20 that -- is when you go on and you develop your scenarios 21 and your -- with like the new lead and the old lead, you 22 basically keep the dust lead and the soil lead compound. 23 You keep the soil lead flat. That's what I'm saying. You 24 don't change that. 25 DR. MURPHY: With regard to the riskMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 217 1 assessment --

2 DR. KOSNETT: Yes.

3 DR. MURPHY: -- we maintain -- we did not 4 try to simulate what the change in air concentration would 5 do in terms of changing soil lead because we had limited 6 data to do that with. And so we held constant, the soil

7 -- the outside soil concentration. We did have a model we 8 looked at (unintelligible) lead in response to air

9 concentrations. 10 But with regard with regard to soil 11 (unintelligible). So, yeah, you're right. 12 DR. KOSNETT: And then building on that. 13 If you'll notice, the contributions of ambient air lead to 14 the various things you talk about indoor house dust, 15 outdoor dust, terrestrial media, biota, aquatic media and 16 sediments. What's missing is food, is the diet. There's 17 nothing -- no section in here of that. The zinc, by far, 18 by far, the overwhelming source of lead to the 19 (unintelligible) of Americans today is in the food. Okay. 20 (WHEREIN, unintelligible due to multiple 21 people speaking at once.) 22 DR. WEITZMAN: To preschool children? 23 DR. KOSNETT: To everybody. And if you 24 look at the Clayton and Benson Table 4-1 in the ISA -- I 25 mean, that -- you know, the food and beverage intake forMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 218 1 an adult is one and three-quarters of lead intake. So the 2 question I have is, do we have -- how much of that is 3 legacy of air lead? 4 And over time, since that's the biggest 5 single component of our exposure, if we change -- you 6 know, to what extent is, is future ambient air emissions 7 going to affect that? And just out of my own curiosity, 8 is that a legacy that is going to last for a long, long

9 time. 10 DR. MURPHY: So I think it's fair to say 11 there's a lot of uncertainty in that area. In the risk 12 assessment, for example, we did -- we did something 13 similar with regard to diet that we did with soil. We 14 didn't try to project what might change in terms of 15 dietary concentrations in response to a changed air

16 standard or air concentrations because we don't have 17 information that allows us to make that projection. 18 It's an area of future uncertainty. I 19 think we recognize there is a pathway there, but 20 connotatively we don't have information that allows to do

21 that. 22 DR. KOSNETT: Deirdre, do you think that of 23 the 10 micrograms a day that the average adult gets in the 24 diet -- or somewhere around there, I should say. Maybe 25 not 10, but say 5 to 15, somewhere in that area. Is that,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 219 1 is that the legacy of lead in gasoline or the airborne 2 lead emissions that they got into the soil or the water 3 and the food supply. I mean, what do you think?

4 DR. MURPHY: I don't have information to 5 make a statement to that issue. As you note, in addition 6 to those sorts of sources, there are also introduction of 7 lead through a different processing that can happen in 8 other countries as well as in the past. So there's a lot 9 of uncertainty. 10 DR. KOSNETT: Does anyone have an idea on

11 that? Michael? 12 DR. RABINOWITZ: Just backing up a little 13 bit here about lead in soil and resampling. It's trite. 14 And it's easy to go back to agricultures and resample it 15 10, 20, 30 years later, no problem. Urban settings are 16 the areas that's pretty difficult because urban activity, 17 just the landscaping, buildings and roads. It's hard to 18 go back and actually sample the same place again and 19 again. It just doesn't work in rural settings like that. 20 It's hard to go back (unintelligible). 21 Like in St. Louis, you go back and see the 22 (unintelligible). We're going to be doing this. The 23 result of all this we're doing is that lead levels go 24 down. The other big change besides taking lead out of 25 gasoline is taking lead out of cans. And that's just a --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 220 1 this disappeared about the same time lead gas disappeared. 2 I don't think we should forget that there will be lead in 3 containers. So most of the spots we can go with our

4 criteria base now. 5 DR. FREY: Did you have a comment? I think 6 you wanted to weigh in on this discussion. 7 DR. DAVIDSON: I did actually. I wanted to 8 get to the first point that Dr. Kosnett made. With regard 9 to looking at lead in soil, there are published 10 resuspension rates for different types of soil. And we've 11 done some modeling. You said there's resuspension rates. 12 In particular, modeling for Los Angeles where you'd expect 13 there to be very high concentrations in soil near the 14 freeways, near all roads. And what you find is that the 15 resuspension rates are high enough so that you can easily 16 get the -- you can use that model, and you can easily get 17 airborne concentrations that are equal to the current 18 measured airborne concentrations in Los Angeles, which are 19 -- which are -- they're not very high, but you know, 20 they're on the order of 30 or 40 nanograms per deciliter. 21 So well below the standard of .03, .04. 22 But you can easily get that by using -- 23 even underestimating resuspension rates and knowing the 24 lead content in the soils. It's interesting, though, that 25 if you solve the equations -- the coupled equations forMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 221 1 lead in soil and lead in air, what you find is that the

2 lead in the soil does not decrease in concentration with a 3 fast time constant by any stretch of the imagination. 4 In other words, there's a huge reservoir of

5 lead and that lead adds to the airborne lead 6 concentration. Indeed, we believe it may be mostly 7 responsible for the airborne lead concentration. But the 8 soil reservoir is not decreasing in its lead level over a 9 time scale of several years. You actually have to be time 10 scales of many decades before you see, before you see a

11 reduction. Which is one reason there was a lot of concern 12 -- at least I was concerned over, What's the ultimate fate 13 of the millions of tons of lead deposited on urban soils. 14 It's not going to go away by itself. And actually I agree 15 completely with what Dr. Rabinowitz said about moving soil 16 in urban areas. That's the way the soil is removed from 17 urban areas. It's when a developer comes in and actually 18 uses a bulldozer and removes big chunks of soil. That's 19 going to get rid of it, by not allowing the wind to 20 naturally resuspend it. 21 DR. KOSNETT: And what do you think -- do 22 you think that the lead in the diet, which is the biggest 23 source for the average American -- is that, is that 24 enduring legacy of past emission or is that from something

25 else?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 222 1 DR. DAVIDSON: Okay. So this goes back to 2 the National Academy of Science panel back in 1980, which 3 I was on, where we looked at lead in the diet, lead in 4 water, lead in dust and so forth. And at that time, the 5 typical lead in adult diet was around 7,500 grams per bit, 6 so 10 micrograms per bit. And that was contributed -- 7 that 75 was contributed mostly by food. 8 Now, the question is, how much of that lead 9 in food is actually from the air. This is a bit -- it's 10 very difficult to know that because the lead in canning 11 went down. The lead in the air went down, so there's less 12 deposition onto food crops. So, in fact, lead is going

13 down from lots of different sources. So it's not 14 surprising that you have a 10 microgram per day lead 15 intake now from diet. But I suspect that a lot of this is 16 the legacy of gasoline derived lead. Because if you look 17 at the emissions that came from lead, we're talking about 18 millions of tons. Do you agree with that, Michael? 19 DR. RABINOWITZ: I suppose. I mean, I 20 agree that, certainly, lead levels in diet are much lower

21 now. 22 MR. MCNAMARA: Move closer to the mic, 23 please. 24 DR. RABINOWITZ: The question is whether 25 residual sources of lead in the diet. And I guess in theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 223 1 old days you'd see one or two major sources. But now that 2 the general levels have dropped, there's opportunity for 3 smaller sources to be placed in it and roll. For 4 instance, (unintelligible), which used less and less in 5 factories. It used to be lead dairy animals. So you're 6 now going to -- you've seen it on How It's Made, it shows

7 on TV that it's in food in factories. So there are 8 bearings and little bits of metal wind up in it. It's a 9 microscopic analysis. 10 You know, Chris -- you pick up a glass 11 somewhere and it's heavy, there's lead in it. And maybe 12 Dr. Weitzman will have some more recent data, but I'll bet 13 from crystal radiates into the diet. Of course, it's 14 porcelain. It's imported. (Unintelligible.) 15 I don't think it's -- I could be wrong. 16 That's why I come to meetings. You could tell me I'm 17 wrong, and I'd learn something. I may be wrong, but I 18 think residual -- the legacy of lead in gasoline is no 19 longer a source of agriculture, and I don't think it's

20 much of a source in diet and a few of these other little

21 sources.

22 DR. KOSNETT: I don't know. 23 DR. RABINOWITZ: This is my seat of the 24 pants answer. 25 DR. KOSNETT: I don't know, and I don't --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 224 1 I haven't seen data on it. It's not in the 1,600 pages. 2 Like I said, it's not -- and we don't know, but it's an 3 interesting question. I don't want to waste any more 4 time, but it's an interesting question. 5 DR. WEITZMAN: Well, I just think it's the 6 largest single source, you know, to have, right? There's 7 also lead in water, right? 8 (WHEREIN, unintelligible due to multiple 9 people speaking at once.)

10 DR. FREY: Yes. 11 DR. WEITZMAN: If every, every 12 municipality, every state has a lead program that deals 13 with lead in paint in the houses. And so I'm confused 14 when you say that the majority of lead comes from food.

15 Is that true for children with blood lead above five? 16 DR. KOSNETT: I'm not talking about that, 17 no. No. I'm talking about -- I'm not saying -- 18 (WHEREIN, unintelligible due to multiple 19 people speaking at once.) 20 DR. KOSNETT: I'm not saying that. I'm 21 saying for the background -- the background person that's 22 had blood lead of about 1.3. Right? Isn't that the 23 geometric -- you look at what is maintained -- you know, 24 what is the input that we get on a daily basis, the 25 biggest single source that we can trace. Not to the leadMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 225 1 worker, not to the child. Other people. It's lead in the 2 diet. It's not lead in the air. I mean, that's a 3 (unintelligible), right? It's not lead in water 4 necessarily. 5 So we don't breath it, we don't drink it. 6 It's -- because we eat it, you know. And some of it we 7 get from soil. But if you add up all the numbers, the 8 biggest source is diet. 9 DR. FREY: I guess this discussion also 10 prompts me to point out -- and we talked about this 11 earlier that, you know, the one thing we can advise the 12 administrator and the agency on is data needs and research 13 needs. And if this is an area where not a lot is known, 14 you think it's tangent or relevant to informing the next 15 round of review of the standard, this may be something

16 we'll want to mention. 17 And related to that, I do want to -- I 18 guess for all the charge question lead discussants, both 19 of the ISA and Policy Assessment, I would encourage you 20 and your groups to identify if their research or 21 information needs are relevant to your topic areas. And 22 maybe, you know, separately list them and a few bullet

23 items. 24 I guess depending how many we come up with, 25 we may want to call that out as a separate component inMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 226 1 the letter to the administrator. And part -- I don't want 2 to change things by saying we're moving along pretty well. 3 If we have some time tomorrow morning after we complete 4 the charge questions, I think it would be worth a few 5 minutes just to see where we are on wanting to recommend 6 research or information priorities. 7 It also reminds me that -- I wanted to ask, 8 and I don't mean to put anyone on the spot publicly in 9 front of the entire panel, but Dr. von Lindern, would you 10 be willing to volunteer to draft some text related to the 11 unintended consequence or the -- you know, that issue that 12 we talked about earlier of kind of the global displacement 13 of lead as a potential adverse impact that we might want 14 to point out to the administrator. And would you be 15 willing to kind of serve as a lead? I think you're

16 best -- 17 DR. VON LINDERN: I guess I asked for that. 18 DR. FREY: Yeah, I think so. 19 DR. VON LINDERN: Yes, I will. 20 DR. FREY: Okay. So if anyone has input on 21 that, I would encourage you to -- okay. So having said 22 those things, any other discussion on Chapter 2? Yes,

23 Rich. 24 DR. CANFIELD: So just going back to the 25 notion of a point source that is being commissioned andMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 227 1 maintains its pollutant ways, does that suddenly become a 2 non-regulated site, or what -- I mean, if -- 3 MR. CAVENDER: The actual requirements for 4 lead monitoring, we regulate the states who put the lead 5 monitorings out. We put in a regional administrator 6 authority that can require a monitor anywhere where 7 there's a decision that the lead NAAQS may be exceeded. 8 And then the previous preamble to that of 2010, which was 9 2008, we specified one area in particular they should be 10 using that authority in a recently closed facility. So 11 they don't automatically get out. We're hoping that 12 they'll still be addressed to that approach. 13 DR. RABINOWITZ: Just a quick comment. 14 Perhaps, you can guide us on this. Don't most old, 15 closed-up lead factories become Super Fund sites and, 16 thus, they're monitored? 17 MR. CAVENDER: I don't know, but I would 18 suspect yes. I've heard many have never officially closed

19 to avoid that. 20 DR. FREY: Well, it sounds like we might be 21 at a good point for a break now. Let's take a break until 22 -- let's do a 15-minute break, which would take us to 23 4:20. And then we'll take on Chapter 3. 24 (WHEREIN, a brief recess was taken from 25 4:03 p.m. to 4:20 p.m.)Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 228 1 DR. FREY: All right. The only thing 2 between you and dinner is our discussion of Chapter 3,

3 so... 4 I have a list of people that want to 5 mention something briefly. I'll start with Dr. Murphy and

6 then Dr. Kosnett. 7 DR. MURPHY: I just wanted to mention since 8 there was much discussion previously about research needs 9 that we do -- although we did not include a charge 10 question, but at the end of Chapters 4 and 6, there are 11 sections with regard data gas and areas for future 12 research. And so your consideration of that and focus of 13 your comments in that way might be a (unintelligible) way 14 to go. 15 DR. FREY: Yeah. Thank you. That's a good 16 point. Yeah, I have noticed that those were there, which 17 is great. Michael, you promised a brief comment. 18 DR. KOSNETT: Yeah, just briefly. I mean, 19 we had some discussion during the break about the 20 contribution of dust and lead, and I was -- I revise what 21 I said. For adults diet is the most important part, but 22 for children those actions and analysis suggest that dust 23 is more important. 24 DR. WEITZMAN: I'm glad you revised it 25 because then we were going to have to rewrite --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 229 1 (WHEREIN, unintelligible due to group 2 laughing.) 3 DR. KOSNETT: Yeah. So it's for adults, 4 not for children. So I just wanted to clarify that on the

5 record.

6 DR. FREY: I know Michael's relieved 7 because we were talking about that during the break also. 8 So thank you for that clarification. All right. Let's go 9 to Chapter 3. And we have an esteem group of five 10 discussants. Rich Canfield is the lead, and then Michael 11 Kosnett, Joel Pounds, Gail Wasserman and Michael Weitzman

12 are also discussants. 13 So I'll yield the floor to Dr. Canfield.

14 DR. CANFIELD: So -- 15 DR. FREY: Oh, and I'm sorry to interrupt. 16 Just one thing, the -- I was asked to remind everybody 17 please use your microphone, which you are doing and I want 18 to congratulate you for that. But I want to make sure 19 everyone remembers to use the microphone. 20 DR. CANFIELD: Okay. So Chapter 3. I have 21 sort of the full view of Chapter 3. On one hand I think 22 it reviews the evidence and is fairly complete. But I, on 23 the other hand, think it's extremely difficult to get 24 through. And it's -- I think it's clear that it's a

25 draft.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 230 1 So it -- I have a lot of comments that are 2 really stylistic, but it -- I think it was to the point. 3 And at least in my reading -- maybe it was too late at 4 night when I was doing it, but I felt like that complexity 5 of the expressions were interfering with my ability to 6 keep the thread and, you know, feel confident about my

7 evaluation. 8 So -- and I recognize this takes just a, 9 you know, herculean amount of condensation to get Chapter 10 5 down to this. So I congratulate you on that. That is 11 not easy in any way. And these accurate sentences have to 12 have parentheticals to refer to, you know, sections in the 13 Chapter 5, and there are other qualifiers, but something 14 -- it just gets out of control. But it's primarily 15 stylistic things, which in this case became partly a 16 problem with clarity, just in general. So I think it was 17 reasonably complete, but not reasonably clear. 18 So with respect to the first charge 19 question, that is that. I think it generally captures the 20 key aspects of the evidence. And my concerns about 21 content are really just related to content in the ISA 22 rather than the translation of it in here. There may well 23 be places where others will find a lack of translation for

24 me to -- it was more the -- the content seemed to be 25 fairly complete.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 231 1 So in the second charge question, to what 2 extent is the newly available evidence on air-to-blood 3 ratios appropriately characterized and considered in light 4 of information previously available in past reviews.

5 So I think it's -- the context is clear. 6 The history is laid out. It's clear there's no change in 7 the -- recommended at this time, given the data context. 8 And I think especially in this section, 2.1, it was often

9 the case that it's not until the end of the section that 10 you got the message that you wanted at the beginning of 11 the section to help you understand what it's saying 12 essentially. That's distracting. So I'm sure all of that 13 goes together. 14 So, also, what extends to newly available 15 evidence, Charge Question 3, to what extent is newly 16 available evidence on concentration-response functions for 17 IQ decrements in young children appropriately 18 characterized and considered in light of information 19 previously available in past reviews. 20 Now, I take that to be a question about, 21 Did you really capture what you needed to capture from the

22 ISA in this short document. And I think there could be 23 various (unintelligible) because there are a lot of angles 24 to the concentration response, if you will. 25 I think the newly available data isMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 232 1 appropriately characterized and weighted. I think that 2 the importance that you give to it is appropriate. Even 3 though I think parametric information could be extracted 4 from the data in the more current -- the recent studies, I 5 don't think that I would want to see the previous studies 6 weighted by less reliable information. So I think that 7 the weighting is despondent. 8 And I also think, in terms of 9 characterizing this context, that you correctly identify 10 that we really have a lack of information of lead levels 11 to verify range. And we have the problem -- or we just 12 don't know what that -- what the approaching origin means

13 in low-level lead. 14 So on to Charge Question 4. I actually 15 should have said if any of my co-panel members want to 16 jump in, you can. I am getting on to Charge Question 4. 17 So feel free to jump in. 18 So Charge Question 4. With regard to the 19 exposure and risk information, to what extent is the 20 information drawn from the human exposure and health risk 21 assessment in the last review sufficiently characterized 22 and clearly communicated. To what extent is the 23 information appropriately interpreted in light of the 24 currently available information and for the purpose of 25 assessing the adequacy of the now current standard.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 233 1 So I think the information in the last 2 review was well-characterized and appropriately 3 interpreted, but the clarity of this communication can be 4 improved. And I think it's clear, and I agree that new

5 REA is not warranted at this time. But I would like to 6 know that at the beginning of the sections rather than at

7 the end. 8 So Charge Question 5. Are the limitations 9 and uncertainties in the exposure/risk information 10 appropriately characterized and considered in our 11 interpretation of the information in the context of this

12 current review. 13 They -- the limitations and uncertainties 14 are all characterized. The epidemiological data are 15 inherently limited, and there's a lack of data on the 16 effects of exposures at levels common today. And, thus, 17 their concentration response estimates are uncertain. 18 Primary choices for biokinetic models 19 typically require restricted assumptions, and that's a 20 source clearly identified. And there's no single air 21 quality scenario that covered all basis. So in many ways 22 I felt like the uncertainties and limitations were, were

23 clear. 24 I have a -- just a couple of potential -- 25 potentially important wording changes or things toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 234 1 consider, I should say. One is, there are a number of 2 places where I would appreciate a change -- or appreciate 3 change of business. I think this goes back to a common -- 4 this is on other sections, where it would be good to say 5 when the new information reinforces, strengthens or 6 otherwise improves the interpretation of the previous

7 information. 8 And so maybe the notion of whether there's 9 any quality of change would be important or something 10 that's a bigger jump and appreciated. So clearly no -- 11 nothing that is qualitatively important as has been put 12 out recently. So, again, this could come up in Chapter 5, 13 but I'm -- the ISA, but it seemed by the time I got to 14 this condensation of all the information, I looked at 15 Table 3-2 on Page 321 -- 3-21. I am wondering whether the 16 24 month Bayley data are sufficiently strong to merit 17 presenting at this level of the review. 18 And I would be interested in my colleagues' 19 views of that, just my -- and for those not in the area, 20 the fact that 24 months is a timely behavior still 21 changing radically in the child's mode of expression, his 22 language and solve problems, that are pointing to -- it's 23 difficult to predict much in later function and later IQ 24 based on those kinds of scores. They go through the 25 (unintelligible).Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 235 1 And so I would kind of put the baby in a 2 different category than all of the IQ data. Again, that 3 could be, I think, justified for -- for the ISA, but I 4 just felt like it was out of place here -- or it could be 5 reasonably considered to be out of place here. And others 6 may provide their perspective on that. 7 I thought that your discussion about -- and 8 this could have gone any way -- the limitations and 9 uncertainty section, but your -- Page 22, Line 17-23, very 10 nice discussion of the problem with unknown earlier 11 exposures. That comes up many times in this chapter, and

12 I think it becomes redundant at times. And -- but there 13 is a need to mention it again and again. It's 14 appropriate, but I think it -- you could expand a little 15 bit on this section on Page 22 and maybe include that as a 16 particular cross-sectional settings and maybe put that

17 earlier so that -- so that that issues is dealt with and 18 find a shorthand way to refer back to it when it becomes

19 relevant later. 20 At this point, most of it is in this place 21 -- or you get little dribs and drabs of the -- of the 22 aspect of this issue that are relevant to the specific 23 context, and then you have to say more than you need to -- 24 more than you should need to. And that's fine. So that 25 would reduce the redundancy and just make this issue -- aMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 236 1 very important issue clear throughout the document. 2 So besides wording issues and some 3 clarification questions and things like that, that's my -- 4 that's all I have to say. 5 DR. FREY: Okay. Thank you. Dr. Kosnett. 6 DR. KOSNETT: I agreed with the analysis in 7 Chapter 3. I thought that it was well-presented and 8 cognitive. It was appropriate to use the modeling of the 9 slopes to the lead air relationship, blood lead air 10 relationship. I was -- thought it was a nice analysis. I 11 don't really have a substantive critique to offer about 12 that, so I'll be brief. 13 DR. FREY: Okay. Thank you. 14 DR. POUNDS: I thought following Michael I 15 would have a chance to drink my coffee. So with respect 16 Charge Question Number 1, the answer is yes. This chapter 17 maps very well to the relevant -- I can say chapters in 18 each bulleted and bold question, that it's in this 19 chapter. It's very clearly linked to the ISA. It was 20 easy to read that way. The data and conclusions are 21 compared and contrasted clearly and concisely with the

22 evolution of data. 23 With the conclusions of the previous 24 review, there were occasions when I thought that there was 25 too much data. This may be because of spending a lot ofMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 237 1 time with the areas over the last couple of years. But I 2 thought that -- I can -- I reread this (unintelligible). 3 As Rich said, when you get to -- you know, what's the

4 bottom line? 5 There was one -- and I guess this is 6 Question 5. (Unintelligible.) And I'll have to say it 7 too, because I think I'll say it a little different. That 8 there's an enormous amount of EPA experience that they've 9 derived in this effort in the last couple of years. 10 Policy assessment too often concludes the review, or the 11 recent literature does not provide any new insight. 12 So as a reader, I have to conclude -- well, 13 can we regulate the lead as low as we have to go, or we're 14 not doing the time and research that we need with the 15 appropriate external designs to support regulation of lead 16 levels that we're going to be facing in five years. 17 I'm suggesting that rather than cutting 18 back on collecting our data, our ideas, that the EPA 19 should systematically address the adequacy of the existing 20 data and identify explicit data caps that are yet to 21 support what we expect to be lead exposure relevance in 22 the -- 2017, '18. (Unintelligible) dealing with models 23 that were published 20 years ago and haven't been 24 adequately updated or reparameterized with modern biology,

25 and I think that's indefensible.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 238 1 To change the subject, one key aspect 2 that's not incorporated into the policy analysis 3 adequately and that's -- although, I think that they 4 looked at the appropriate model and comprehensively 5 incorporated the key aspects, but Chapter 4 included some 6 nicely articulated limitations of blood lead emission in 7 situations of changing lead exposures there. This concept 8 should be introduced to the policy a little bit more 9 directly. 10 And then one potential confusing part of 11 the task, and that's in Question 2, is the expression of

12 the air-to-lead ratios. Sometimes these ratios are 13 expressed as 1:2 or 1:5, other times they're reduced to a 14 slope. So I have to do this mental arithmetic in my 15 calculating division state to try to contrast and compare 16 -- and contrast air regulations from adjacent paragraphs, 17 for example. Just a consistent use of notation would 18 improve the reading a little. But the chapter did meet 19 the goals that it set out for itself.

20 DR. FREY: Rich. 21 DR. CANFIELD: I just want to clarify. 22 They're coming up with different lead mentions in Chapter 23 4, and -- 24 DR. POUNDS: They give you time not to -- 25 air regulations?Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 239 1 DR. CANFIELD: No. The -- you're saying 2 different ways of measuring blood lead or --

3 DR. POUNDS: No. The -- more the -- the 4 inability of the given blood lead to inform -- 5 (WHEREIN, unintelligible due to multiple 6 people speaking at once.) 7 DR. CANFIELD: Okay. Okay. 8 DR. FREY: Okay. Great. Let's see.

9 Dr. Wasserman. 10 DR. WASSERMAN: I have (unintelligible), 11 except I would -- 12 (WHEREIN, unintelligible due to multiple 13 people speaking at once.) 14 DR. CANFIELD: If you take a look at IQ

15 scores --

16 DR. WASSERMAN: At Table 3-2? 17 DR. CANFIELD: Oh, is that the one? I'm 18 sorry. Maybe I'm -- maybe I'm -- 19 (WHEREIN, unintelligible due to multiple 20 people speaking at once.) 21 DR. WASSERMAN: Is that the table you're 22 looking at? 23 DR. CANFIELD: I'll check it out, but I 24 agree with you with this. If it's not just IQ plus 25 Bayley, then I would agree with -- I'll leave it at that,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 240 1 but I think I looked at it differently. 2 DR. FREY: Okay. Thank you. Dr. Weitzman. 3 DR. WEITZMAN: I concur with what my 4 colleagues said before me. 5 DR. FREY: Okay. Other discussion on 6 Chapter 3? 7 DR. CANFIELD: I would like to formally 8 withdraw my comment on Table 3-2. It doesn't -- it is a 9 hot shop, so... 10 DR. FREY: Okay. Other comments, 11 discussion on Chapter 3? 12 (No response.) 13 DR. FREY: Okay. Well, I would propose 14 that -- we're actually a little ahead of time on our 15 agenda, but I think it might be good if we use the time we 16 scheduled and continue through 5:30 if the Chapter 4 17 discussants are willing to do that. 18 And my thought is, we may or may not get 19 through all of Chapter 4 today. But it might be good to 20 go through it this afternoon and then reflect on it this 21 evening, and then we can pick up again with it. I think 22 Chapter 4, in some ways, is kind of the bottom-line key 23 thing, right? This is where the EPA is making a 24 recommendation about that standard, and so what's what 25 this whole process -- at least for the primary standard isMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 241 1 culminated to. 2 So we have three discussants, which is 3 Deborah Cory-Slechta, Sean Hays and Susan Korrick. Would 4 you-all be amenable to proceeding? 5 (WHEREIN, group nods heads.) 6 DR. FREY: Okay. With that then, I would

7 like to turn the floor over to Deborah. 8 DR. CORY-SLECHTA: Okay. I'm going to go 9 through the charge questions, and I'm going to talk about 10 the reality perspective and then sort from an academic 11 perspective with respect to a couple of the charge 12 questions.

13 I did feel that the evidence-based 14 framework from the last review is appropriate. I was on 15 that review, and I felt it was appropriate then. And that 16 the new literature really just provides further support 17 for the health effect conclusions that are presented in 18 the prior review. Fundamentally, we haven't really

19 altered that much of the uncertainties. 20 The second of those questions is, What are 21 the panel's view on staff's interpretation of the 22 exposure/risk information, and on staff's conclusions that 23 the information is generally supportive of the conclusions 24 drawn from the evidence-based framework as to the adequacy

25 of the current standard.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 242 1 If felt that he exposure-risk information 2 from the prior review does appear appropriate given the 3 absence of significant new information that's really been 4 a fundamentally change in the interpretation. 5 The third question seemed like a little bit 6 of an open question, and here's where I'm going to say 7 something that I said in the last review of CASAC review 8 of lead. That is, What are the panel's views on public 9 health policy judgments that inform staff's preliminary 10 conclusions with regard to the adequacy of the current

11 standards. 12 And I have a couple of statements here. 13 One, the document states repeatedly that no threshold for 14 lead effects on IQ can be identified. But I think this is 15 a bit of an overinterpretation. We're now seeing reports 16 of blood lead levels -- reductions in IQ of blood lead 17 levels as low as 2 micrograms per deciliter. In essence, 18 we're seeing effects being reported at the lowest blood 19 lead levels that are -- can be reliably measured. So 20 we're basically right up against the wall. 21 So where the threshold is going to come in 22 there, I don't really know unless we start doing all the 23 blood lead by ICPMS or AAS, which isn't going to happen in 24 the field. So the idea that there's a threshold, in my 25 view, sort of contradicts the literature that continues toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 243 1 accumulate. 2 Okay. There's statements that the 3 regulations -- again, this from my different perspective. 4 The regulations do not require that a zero risk be 5 achieved, neither does it prevent it. It doesn't say you 6 cannot go to a zero risk. And so given that and the fact 7 that we have this supra-linear concentration-response 8 curve that had been demonstrated in several studies, it 9 becomes difficult, at least in my mind, to support a 10 standard based on a one to two IQ point loss from a 11 neuroscience/psychology biological perspective. 12 I said this before, I'll say it again. The 13 fact that we're basing the standard on some level of 14 degeneration of function, it's really difficult for me as 15 a neuroscientist and psychologist to really seem 16 appropriate. And from a public health perspective, I 17 don't really want to be the one in the room telling them, 18 Don't worry. It's only a one to three IQ point loss, at 19 least just from -- whatever. 20 So I don't know. Maybe get some wording 21 with respect to this -- especially the threshold level, 22 you might want to think about. And, you know, from a 23 policy perspective, we are making judgments based on 24 what's an acceptable loss of IQ. And that has public 25 health consequences. It has social ramifications. And IMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 244 1 brought it up five years ago, and I still believe that. 2 With respect to the last two, In the panels 3 view, does the discussion in Section 4.3 provide an 4 appropriate and sufficient rationale to support the 5 staff's preliminary conclusion that it is appropriate to 6 consider retaining the current standard. 7 And, you know, I have to answer yes, given

8 the evidence-based framework and the fact that we are now 9 down to lowest blood lead levels that can be reliably 10 measured, at least in the field. So it's not really clear 11 that we would need all these IQs anymore. It's become a 12 bit of a moot point in a way. Well, you can expand that

13 discussion as well. 14 And any recommendations regarding 15 additional interpretations. I would just go back to the 16 repeated statements about the threshold because I just

17 don't see how that fits with where we are in terms of 18 reliability of blood lead measures by almost all the 19 laboratories that are part of the quality control programs 20 doing these and where we're seeing the IQ reductions. So 21 those are my comments. 22 DR. FREY: Okay. Nice mapping to the 23 charge questions. Let's see, our next discussant is 24 Dr. Hays. 25 DR. HAYS: Thank you. It was nice to readMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 245 1 Chapter 4, but it was kind of like, you know, reading what 2 we thought was going to come out when we saw the first 3 draft of the ISA. You pretty much knew what was going to 4 be the conclusion, and they gave it to us. 5 I concur with respect to the answers to the 6 charge questions that Deborah provided. Provided, it sets 7 for the argument for there's no special literature as

8 well. So I'm on that. 9 I think the -- there's some very profound 10 statements in Chapter 4, at least I was -- I followed my 11 chair reading. Page 4-28, Line 2-3, it says: We also 12 recognize increased uncertainty in projecting the 13 magnitude of blood lead response to ambient air

14 concentrations at and below the level of the current 15 standard. As we talked about in the science assessment, 16 they are withstanding the relationship between air and 17 blood at the low levels that we have today. It is

18 uncertain. 19 Now, Page 4-32, Lines 33 through 35: In 20 staff's view, based on current evidence there is 21 appreciable uncertainty associated with drawing 22 conclusions regarding whether there would be reductions in 23 risk to public health from alternative lower levels as 24 compared to the levels of the current standard. 25 Now, having listened to what Deborah saidMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 246 1 about the IQ levels going on even at the lowest exposures, 2 perhaps, this sentence should be rewritten to write -- to 3 read something about drawing conclusions regarding whether

4 there would be reductions in blood lead levels from 5 alternative lower levels. That's compared to the level

6 standard.

7 And I think that -- I think that some of 8 the things Michael has said that it occurs that -- Michael 9 was mentioning about diet as a primary level of exposure 10 or dust. The reduction in air levels beyond -- below the 11 NAAQS. There may not be an impact in low blood lead 12 levels. So I guess I would recommend that change. So 13 instead of saying reductions in risk to public health, say

14 reductions in blood lead levels. 15 I agree that the new science does not 16 support lowering the NAAQS any lower than its current

17 level. 18 Deirdre, you did ask about our input on 19 these concluding sections on uncertainties and future 20 research and data collection. I actually liked those a 21 lot. They're very good. 22 One of the statements in there I thought 23 was really profound, but it was really vague the way it 24 was written was, you said: Apportionment of blood lead 25 levels with regard to exposure pathways with a particularMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 247 1 focus on understanding -- the particular distinction 2 pertinent to policy relevant exposures in background

3 sources. 4 Well, I kind of rewrote that and said: 5 Apportionment of blood lead levels with regard to exposure 6 pathways, particular focus on understanding pathways and 7 sources that cause more elevated blood lead levels among 8 children today. 9 Now, I catch what you-all were trying to 10 say there, but I think that was the issue. What is 11 causing the elevated blood lead levels in children today, 12 and what can you do to reduce those exposures. And I 13 think this gets back to, you know, air is not the driving 14 factor anymore. It's the other sources. 15 You know, I reiterate a comment I had given 16 a long time ago, and that is how tough Canada -- and I

17 think Michael was involved in that as well. How the 18 Canada set up their regulation. What they did is similar 19 to what you did in terms of assessing blood level and IQ 20 decrements and coming up with target blood lead level. 21 But then across the agency, then, they 22 said, Okay, we need to get down to this level. Let's say 23 2 micrograms per deciliter. How do we do that? And they 24 said, Okay. Air, you get 20 percent. Soil, you get 40 25 percent. Diet, you get the other -- whatever, I can't doMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 248 1 the math in my head that fast. And then they go, Portion 2 it that way. They said, Okay. Go get it and we'll come

3 to that level.

4 And that makes sense. And I think this 5 gets back to some of Ian's comments earlier about, you 6 know, this -- this blinder's view of air being 7 (unintelligible), and I know that's a mandate through 8 NAAQS. But lead is different than that, and you've got it 9 regulated from a multimedia source. I think that kind of 10 approach will be really useful. 11 Now, how you do that, I don't know. Take 12 it out of the NAAQS and put it in something else. 13 Initially ambient -- multimedia exposure quality standard. 14 I don't know, something like that. But that's how the 15 agency can handle these issues and how we can do so. But 16 the blood lead levels and public health risks in the 17 future don't (unintelligible). So that's it. 18 DR. FREY: Okay. This -- well, thank you. 19 Yeah. So you've got to give a national multimedia 20 standard. This reminds me that for a number of years 21 there's been discussion about multipollutant air quality 22 standards, and -- so I think we could expand that concept 23 in giving kids plenty of food (unintelligible). I'm happy 24 to develop regulations. 25 But I think from a science perspective,Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 249 1 that certainly makes a lot of sense -- from a statutory 2 mandate perspective as a challenge for EPA. 3 Well, let's see. Our next discussant is

4 Dr. Korrick. 5 DR. KORRICK: So I actually don't have much 6 to add. I think the previous -- Deb and Sean summarized 7 things real nicely, except that reiterate -- I think the 8 language is important here. And we talk about a -- it had 9 a reduced risk to the public health in the context of a 10 standard that potentially is associated with a couple 11 points loss of IQ in most exposed children. I think it's

12 a little better. 13 As with what Debbie said, I find that a 14 little difficult as a public health message. And then I 15 think that the uncertainty -- as Sean said, the 16 uncertainty in that issue is whether reducing the standard 17 further than what you have children's blood lead levels, 18 not whether it has an impact on protecting their health 19 because I think the current standard has already

20 demonstrated that it has some limitations in terms of its 21 public health protectiveness. Which is, I realize, a 22 policy decision by a health point of view. It's not 23 optimally protected. So I think that language is actually 24 really important. It's just that our message isn't

25 communicated.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 250 1 Now, I think I -- sort of on a more generic 2 basis, in the document there's obviously a lot of emphasis 3 on areas of uncertainty. And the importance of 4 uncertainty and categorizing cannot be done at this point 5 in the process. But sometimes I felt as if it was a 6 little bit of a cop out. There's more known, perhaps, in 7 some instances than was explicitly acknowledged.

8 So in terms of the discussion of the 9 standard using three-month averaging, not to be exceeded 10 by the level of form, there's language saying that that's 11 -- there's a lot of uncertainty about the timing and 12 duration of lead exposure that's relevant. And I would 13 say that's true, but that there are some perimeters that 14 we're very aware of that are applicable that could be 15 mentioned in that example. 16 So, for example, we know that the exposure, 17 we kind of see, are adverse in terms of developmental 18 outcomes. And pregnancy has a self-limited time period, 19 and there's even some data to suggest that exposures 20 during some trimesters are at more lead risk. So one of 21 the bounds of that uncertainty is that we know that 22 exposures leads to early childhood, over a period of 23 months, are relevant. 24 And then a lot of the children's IQ data 25 goes out, say, age six or seven. So you know that theMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 251 1 time frame this -- in the scale of months to a handful of 2 years. You're not trying to extrapolate, at least based 3 on the health outcome that's considered most synthesized. 4 You have to kind of extrapolate over an adult lifetime. 5 So to say there's uncertainty about the 6 relevant time period and duration of exposure is an 7 accurate comment, but we do have information about grammar 8 trends a little bit that is relevant to the form standard, 9 and maybe the standard makes sense. 10 And I think being able to acknowledge that 11 means that much. It's more detail than we want to put in 12 this kind of assessment, but I think acknowledging that is 13 actually helpful to the reader because uncertainty and 14 lack of characterizing information are not dissonant. You 15 can have both things going on simultaneously. I think 16 that's the case for a lot of the uncertainties that play 17 into this policy assessment. 18 So I think that's the only, sort of 19 additional, comment that I would make. 20 DR. FREY: Okay. Great. Other comments on 21 Chapter 4? 22 (No response.) 23 DR. FREY: And in particular -- you know, 24 so this is -- as I said earlier, this is kind of the 25 bottom line for the primary standard. Any furtherMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 252 1 comments regarding indicator or level, the averaging time,

2 the form? 3 (No response.) 4 DR. FREY: Is there any -- I guess in the 5 absence of a comment, does that mean sort of by silent 6 consent that the panel's comfortable with the EPA's 7 proposal to retain the current standard and all of those

8 attributes of the standard or what the indicator of level 9 averaging time form. And if not, speak now. Okay. So 10 Phil, Herb and Deborah. 11 DR. HOPKE: Okay. Well, again, let me 12 bring -- bring up the issue of the form again. I mean, 13 I'm not opposed to the form, but I don't think it's been 14 very well presented. I don't think it's been very well 15 justified. I don't think it necessarily, you know, has 16 the context of the kind of exposure, you know, relative -- 17 you know, how does it really relate to the exposure and 18 add protectiveness to the standard? 19 We see in these kinds of discussions, for 20 example, in -- you know, the percentile standard aquatic 21 to PM 2.5. We haven't seen a parallel kind of discussion 22 here. In fact, at this point -- you know, like I said, 23 this is a holdover from the original 1970 whatever and, 24 you know, we've learned just a little bit since then in a 25 variety of fields.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 253 1 And it might be nice to understand what the 2 thinking was then and why we believe that's still 3 (unintelligible). I'm not suggesting necessarily that it 4 be changed, but I don't think at this point the status quo 5 ranthy (phonetic) is -- has been very well justified.

6 DR. FREY: So is that focused on the not to

7 exceed --

8 DR. HOPKE: Yeah. 9 DR. FREY: -- aspect of the form? 10 DR. HOPKE: Absolutely. 11 DR. FREY: Okay. All right. Well, that 12 may be something -- and, Rich, do you want to address that

13 issue? 14 MR. POIROT: Well, just to follow up on 15 that. You know, in some ways the form has become more 16 stringent with the last review and that it used to be, I 17 think, a fixed calendar three-month quarter. And now it's 18 rolling. And so those two aspects of the form -- 19 DR. HOPKE: Right. But they're -- in 20 neither cases there have been analysis of data or anything 21 shown why this is good, bad, different, better. 22 DR. FREY: Okay. Well, let's see, Herb had 23 his hand up. 24 DR. ALLEN: I really like what Sean had to 25 say about basically the multimedia exposure because that'sMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 254 1 what it is. And as you lower the amount of exposure from 2 air, it becomes less and less important. And that really, 3 I think, comes across -- so what happens when air no 4 longer is of importance, and what is the form -- what kind 5 of standard do you have for air where you are basically

6 force the habit of their standard because that's the act 7 if air no longer is a factor. 8 DR. FREY: Well, that -- yeah, that's a 9 good question. Yeah, so the NAAQS -- and I'm not a 10 lawyer, so maybe the general counsel of the EPA could

11 answer this better than I can.

12 But I think the -- as I understand the 13 Clean Air Act, it gives the EPA the authority to establish 14 criteria which essentially, as I understand, is basically 15 identifying what pollutants to regulate under the NAAQS. 16 And as I understand it, it is actually -- 17 it is possible to add more pollutants to the NAAQS. I 18 don't think that's been done. But then the flipside, is 19 there a process for removing pollutants from the NAAQS? 20 And that's clearly not been done, either. 21 And, yeah, at some point -- you know, as 22 you say, if the air component drops down -- maybe we're 23 not at that point yet, but is there a point in which -- 24 this is looking at that question.

25 DR. ALLEN: Yeah. And that's what we wereMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 255 1 discussing for an hour or so, on air. If the major -- if 2 food is the major source of lead, what we need to be doing 3 is legacy lead not hurt depositional lead, then do we -- 4 doing anything in an air lead standard is not going to 5 affect -- is not going to affect food. So here what the 6 effect (unintelligible). There is probably as much 7 exposure from the water as there is from the air in many 8 cases, and many cases it's not.

9 Those would be dealt with. 10 (Unintelligible) exposure of any importance is food. All 11 right. And that's going to be a legacy issues, and that's 12 going to be around for a long, long time because lead does 13 not move to ground and water. 14 DR. FREY: Okay. 15 DR. CORY-SLECHTA: I want to underscore, I 16 think Sean's point about the fact that it doesn't impact 17 blood lead at the end of the day, it really has become 18 sort of moot issue. We're down to 2 micrograms now, 19 basically. We're at the lowest reliable measurement 20 levels. So I would agree. Maybe it's time for a 21 reconsideration of lead as a NAAQS, but it's important as 22 a multimedia pollutant. And doing it a different way is 23 just -- it's still there. It's critical.

24 DR. RABINOWITZ: It seems like we still 25 need a standard. Even though we've reduced lead in airMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 256 1 throughout the solo -- it doesn't matter so much. We 2 still need a standard to keep it low. I'm not sure how 3 you best do it, and I need an average not to exceed. But 4 you still need some standard so somehow it doesn't creep 5 up again in some other sources. That's regarding lead in

6 the air. 7 And regarding lead in food, I'm not sure 8 how much of it is still a legacy of airborne lead. I 9 think there's other sources of lead going into our mouths 10 from other sources of contamination, not just old airborne 11 lead that's either in the soil and predislocated and maybe 12 splashed onto the food. There are other sources of maybe 13 in factoring the processing of the intention. 14 DR. FREY: Thank you. Phil and then Sean. 15 DR. HOPKE: Yeah. I just want to point 16 out, in terms of keeping NAAQS code, there's and aphorism 17 by Mark Twain. Never do something bad when someone's 18 watching. Okay. And given the network we have and where 19 we're spending resources to actually make composition 20 measurements, it's very easy then -- so the NAAQS gives 21 you a false sense of security. So beware. Having the 22 NAAQS doesn't necessarily mean that somebody isn't 23 producing -- putting lead in the air at some place for 24 which you're not making composition measurements. 25 DR. FREY: Okay. It sounds like a uniqueMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 257 1 system, kind of, situation.

2 DR. HOPKE: Of course.

3 DR. FREY: Yeah. Sean. 4 DR. HAYS: Within our documentation, it 5 kind of makes it seem like we've succeeded. And maybe we 6 have towards -- with respect to air. But I just came 7 across this quote today. Failure changes for the better,

8 success for the worse. And so we claim success with 9 respect to lead exposures in air. But that maybe creates 10 a false sense of security, like Phil just mentioned. And

11 somehow there needs to be a shown statement about its 12 other sources of lead need to be the focus, and EPA needs 13 to consider how to handle those through the various other

14 tools it has available to itself. 15 DR. FREY: Okay. 16 DR. KORRICK: I'm sorry. Maybe I 17 completely lost you guys. I thought part of the challenge 18 here, it's not that there's not been a huge -- there's not 19 been a huge benefit of lowering air lead levels to public 20 exposure risk and health risk, but I thought that we don't 21 know what proportion of exposure is attributed to air. 22 And we don't know if you have the standard if it would 23 have an impact on lead exposure risk. 24 And it sounds like most people are assuming 25 that we know that the role of their lead is very, veryMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 258 1 small. I mean, I know in adults -- Michael has pointed 2 out there that the food is the major source of this 3 exposure. But even if there are lead -- you get a 10 or 4 15 or 20 percent of exposure risk, given that health risk 5 especially in kids, it's so explicitly sensitive below the 6 exposure. So that can still represent a substantial 7 health benefit to eliminate that exposure source.

8 So I'm a little confused. Did I miss 9 something that -- I feel as if there's an expression of 10 more certainty that some of these more fundamental issues 11 than I have been presented. 12 DR. CANFIELD: And just to go along with 13 that is our ability to claim victory over air lead based 14 on our current ability to measure its effects in the most 15 sensitive -- or on children. So we may find -- so I am 16 somewhat convinced by people who say, you know, pretty 17 dusty will be a moot point, but -- 016 micrograms per 18 deciliter or something. 19 DR. FREY: Yeah. Deborah, you have a

20 comment? 21 DR. CORY-SLECHTA: Well, I think Susan's 22 point is well-taken. Of course, we're beyond primary 23 prevention, unfortunately. But in kids the issue has 24 always been dust and not so much food. And if you look at 25 the young teens blood lead distributions by age, they'reMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 259 1 always highest of the one or two years of age and some of

2 which can come from air. 3 Having said that, those populations are 4 also largely inner-city populations where there's probably 5 so much incorporation into the soil at this point that 6 short of digging it up or completely rehabbing houses, I

7 think that's considered to be the source of those -- for 8 those age groups. So, you know, there is resuspension of 9 air. We did hear about that, and that has been considered 10 for dust. And I think it's being considered in the 11 dust-lead standard. But really the issue here is dust. 12 And this is just a residual contamination. I don't know, 13 you know, where it's going to go at this point short of a 14 lot of money for each contaminated site. 15 DR. KORRICK: Okay. I mean, I think it's a 16 bit -- we were talking about this a little bit; that -- 17 Michael's -- the lead-per-kid study where the data is low 18 leads around houses that had the highest blood lead 19 levels. The impact on health was proportionally very

20 small. So I think the conventional -- what's known is 21 that the dust appears to be the major source of the 22 exposure aspects, but it's not so -- I don't think it's 23 been so clearly apportioned that that's -- maybe I'm 24 wrong. 25 I mean, basically, heavily exposed kids inMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 260 1 inner-city housing who've ingested lead paint are getting 2 exposed from lead paint. But there's a whole lot of kids

3 out there who have a blood lead level of 2 that have not 4 ingested lead paint and that are still along the continuum 5 of children who are going to be adversely affected by 6 lead. And I don't think we necessarily know where the 7 lead is coming from. Is that not correct?

8 DR. HAYS: That's how lead is. 9 DR. KORRICK: Yeah. And so I -- I mean, 10 I'm not saying that keeping the same standard isn't the 11 appropriate thing to do at this time. But I think -- I 12 feel uncomfortable being to (unintelligible) about having 13 finished this story when there's fundamental uncertainties 14 about the role that air lead plays in exposure and the 15 role that changes the standard might claim as exposure. 16 I think that's the area where things are 17 unresolved. And because from a public health point of 18 view, the sensitive outcome -- the outcome is so 19 exquisitely sensitive to small amounts of lead, those 20 uncertainties compound. 21 DR. FREY: Okay. Herb and then Sean and

22 then Phil. 23 DR. ALLEN: I agree with you, Susan. But I 24 think what's needed is a better understanding of what the 25 portions of lead exposure are from various sources toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 261 1 various populations. And only when you have that can you 2 really understand whether a proposal to have the standard 3 stay as it is move up, move down. It's possible. 4 That's when -- when everybody knew that air

5 lead was -- the lead in air was the source of most of the 6 exposure, but it was very simple to set a standard because 7 if you lowered the amount of lead in the air, you lowered 8 the amount of blood. And, you know, the city had a good 9 response. I don't think that's clear anymore. I mean, we 10 have the same issue going on in the ecological one where 11 what we said is, We don't really know how (unintelligible) 12 the critical loads model, which is the same thing we 13 really need on -- you know, it is the equivalent of a 14 critical load, right, to tie these together. Until you 15 have them all tied together, you can look and see where -- 16 where the control is, where the engineering part. And 17 then that becomes the answer to the question.

18 DR. FREY: Sean and then Phil and then

19 Deborah. 20 DR. HAYS: I don't have a comment anymore. 21 DR. FREY: Okay. Phil. 22 DR. HOPKE: Okay. I mean, again, the 23 question is, is lead then -- I mean, I would like to look 24 at a broader context of threats to public health in the 25 air. And is lead really the place where we want to putMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 262 1 the amount of time and effort that we are now relative to 2 mercury or several other things that I can think of. 3 And, you know, isn't it time that we 4 started putting real life into the criteria of pollutants. 5 And it was cleverly designed by congress that they need to 6 be modifiable. We have sat in a very rigid structure for 7 35 years always looking at the same things. And I'm not 8 sure that we're really doing the job we're supposed to do 9 to protect public health with an active margin of safety 10 from broadly distributing multiple sources of air 11 pollutants.

12 And so I would like to see us use this 13 opportunity, not -- probably not this time, but I want to 14 really see av-gas cleaned up and, you know, we'll get it 15 straight. You know, seriously look at the next go-around 16 as the last step and be able to use that as a way of 17 saying, Now, it's time to move on, you know. 18 And I realize that opens a Pandora's box 19 and makes very -- lots of people very uncomfortable 20 because they've made careers out of lead criteria 21 documents -- well, not so much lead criteria documents, 22 only a recent amount out of that. But, you know, isn't it 23 time to think of this as a dynamic system in which we're 24 working to find the most important causes of public health 25 problems. And I don't think our curve approaches that.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 263 1 DR. FREY: Okay. I have Deborah and then

2 Cliff and then Michael. 3 DR. CORY-SLECHTA: Well, I actually want to 4 go back to Dr. Davidson's question that he raised earlier 5 in relation to what Susan was bringing up. Because I 6 appreciate your point, Susan, but I also remember 7 Dr. Davidson asking, What happened to those million pounds 8 of lead that have been dispersed into the environment

9 before. 10 Well, we know where they are. They're --

11 DR. DAVIDSON: Tons.

12 DR. CORY-SLECHTA: Huh?

13 DR. DAVIDSON: Tons. 14 DR. CORY-SLECHTA: Tons. I'm sorry, a 15 million tons. A lot of them are in the inner-city soils 16 and dust where they're going to remain. So I think sort 17 of following up on what Dr. Hopke said as well, so what is 18 the contribution now with the new standard to that huge 19 burden that's already there in those inner-cities? 20 I mean, is it -- is it enough of a -- what 21 they call in psychophysiology a just noticeable 22 difference; that, in fact, it's contributing? I don't 23 know that it is, and I am hearing a lot of people say that 24 that -- you know, we don't really know what the 25 attributable proportion of that is. But there's a hugeMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 264 1 level there already.

2 We now have the standard down to .15. I've 3 heard people say that lowering it further won't change 4 anything. And, you know, at this point -- like I still 5 believe, short of going into these cities and removing old 6 housing and the soil, we're probably not going to 7 influence kid's blood leads. Even changing dietary 8 probably isn't going to change the kid's blood leads. 9 DR. DAVIDSON: Okay. So let me just 10 respond to Susan by saying I think that we do have two 11 separate issues here. One issue is the issue of airborne 12 -- the airborne lead standard at .15 micrograms per cubic 13 meter. And I think we've heard from several people that 14 lowering that standard is not going to do much good at 15 this point. So I think that is one recommendation to

16 count. 17 But I think that the second issue is, are 18 there other things that need to be done to protect -- 19 protect the public, particularly the susceptible 20 population like kids from lead exposure. And I think that 21 is very different than regulating the airborne lead

22 concentration. 23 So, namely, it involves the legacy lead

24 which lead in dust and so forth. So I think these are two 25 separate -- two separate issues. And I think we need toMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 265 1 make that clear in our panel response for the policy 2 assessment; that these are really two very separate 3 issues, but they're important -- particularly the second. 4 DR. FREY: Okay. Go ahead. Michael, 5 Susan, Rich. 6 DR. KOSNETT: Yeah, I agree that there's 7 separate -- you know, they're separate issues. I think 8 the thing we need -- you know, why are we here today? 9 We're here because in 2008 they asked -- they lowered the 10 standard, and -- and under the terms of the National 11 Ambient Quality Standards, there's a five-year review. So 12 we're coming back now and we're looking at the collective 13 data and we're saying that the standard should be

14 maintained. 15 But I think that's an important -- I mean, 16 the fact that the standards at .15 has protected a lot of 17 children in this country. And, you know, there are a lot 18 of sources and perhaps -- potential point sources and lead 19 which are not being developed or used in this country 20 because of this. So I think this standard is protecting 21 us. I mean, you know, we like -- we'd like to maintain

22 it.

23 And there are other sources of lead that we 24 certainly need to go after. And there's a lot of lead, as 25 Debbie mentioned, you know, in certain demographic groupsMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 266 1 -- depending on where they live and what have you. And we 2 need to address that. But let's -- I don't think anyone 3 is saying that we want to forget about what -- I mean, 4 we've gotten a good standard here. It's made a tremendous 5 difference. I think what we're saying here is that based 6 on the past (unintelligible), let's keep it where it's at. 7 But I don't think we want to measure into telling EPA use 8 another method (unintelligible). 9 We shouldn't even approach the fact of 10 saying that it's no longer -- that the standard is no 11 longer necessary because the standard's been a success.

12 DR. HOPKE: No. The standard has not been 13 (unintelligible). You took the gas -- the lead out of 14 gasoline -- out of the catalytic converters. 15 (WHEREIN, unintelligible due to multiple 16 people speaking at once.) 17 DR. HOPKE: -- because you knew that was 18 poisoning the air. I mean, the lead went before the 19 standards went down, but -- 20 DR. KOSNETT: But Phil, the fact that you

21 still have this standard -- 22 DR. HOPKE: No. It has nothing to do it. 23 DR. KOSNETT: There might be -- there could 24 be -- there -- if you wanted to recycle the battery -- you 25 want to be a battery smelter in the United States orMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 267 1 whatever, you'd have to have tremendous air pollution

2 control. 3 DR. HOPKE: Right. 4 (WHEREIN, unintelligible due to multiple 5 people speaking at once.) 6 DR. HOPKE: But you can do the same thing 7 under Section 109 as a point source that happens. You do 8 NAAQS and you do residual risks. And if there's any more 9 risk turns out that we know that the money was for, you

10 have to do more than that. 11 DR. MURPHY: I would just clarify you still 12 have to meet the NAAQS. At any -- 13 (WHEREIN, unintelligible due to multiple 14 people speaking at once.) 15 DR. MURPHY: Yes. In ambient air, you have 16 to meet the NAAQS. And in the residual risk program, when 17 they do risk assessments --

18 DR. HOPKE: No. You don't have to have the 19 NAAQS. You could eliminate the NAAQS tomorrow. But if 20 you had the scientific basis to do that, and I think we're

21 almost there. 22 (WHEREIN, unintelligible due to multiple 23 people speaking at once.) 24 DR. HOPKE: No. That's the point. 25 DR. KOSNETT: For any --Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 268 1 DR. HOPKE: No. They go on and on and

2 forever. 3 DR. MURPHY: If I could just mention -- 4 DR. HOPKE: We're still running with 188 5 hazardous confounds defined in 1970 by congress, and there 6 hasn't been a new hazardous pollutant produced by a 7 general company since -- in 42 years? Give me a break. 8 DR. WEITZMAN: I think carbons, Phil, were 9 eliminated as NAAQS.

10 DR. MURPHY: Yeah. 11 MS. WEGMAN: And you can get a hazard with 12 a high carbons with as NAAQS -- 13 (WHEREIN, unintelligible due to multiple 14 people speaking at once.) 15 MS. WEGMAN: I mean, it is possible to do 16 it, if it were appropriate to do so.

17 DR. HOPKE: Well -- 18 MS. WEGMAN: And just to be clear, it was a 19 1990 measure specifically eliminating NAAQS. 20 DR. HOPKE: Well, in the '70s -- there's a 21 few changes from '70 to '90, but their basic questions 22 remain consecutively.

23 MS. WEGMAN: But the list in the statute 24 came in, in 1990, the correct codes. But in any event, it 25 doesn't really matter. The only point is, we do haveMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 269 1 authority of two above the NAAQS, if that were 2 appropriate. 3 DR. HOPKE: I'm saying not now, but you 4 should be seriously looking at the next go-around if you 5 can get the (unintelligible). 6 MS. WEGMAN: All right. Well, we'll see 7 how that goes. 8 DR. FREY: Let's see, I think -- I almost 9 forgot who the speaker was before. So I know Michael 10 spoke, and then Susan and then Rich were in the queue. 11 DR. KORRICK: Okay. I don't think we're 12 completely in disagreement. Now, I think that if the big 13 picture issue is public health in the future, then 14 figuring out what the most important determinants of lead 15 exposure in kids are and how to best address those would 16 be first on the list. And that sort of incorporates 17 Cliff's first two points.

18 And then I think there's a third issue 19 here, which is that prioritizing components and their 20 relative public health importance is another big picture 21 issue, which I don't -- I don't know. I guess I didn't 22 think about it within the scope of what we're doing, but 23 -- but, no. I mean, if -- you know, if you asked me, it's 24 a professional word that the greatest risk of kid's health 25 today lead in air would never be on the list.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 270 1 So, I mean, I think -- I mean, I don't know 2 whether the NAAQS have changed with prior criteria 3 pollutants. But ingestion comes up, you know, from a 4 societal point of view. What are the things that most 5 impact the quality of children's lives. This isn't one of 6 them, but that's a huge charge to try to come up with the 7 priorities for research money and for resource allocation 8 if children's health is your first goal. 9 So I mean, that's a third issue, but I 10 think it's kind of beyond what we're doing today. 11 DR. FREY: Okay. Rich. 12 MR. POIROT: I've decided I'm too ignorant 13 about policy issues to ask the questions. 14 DR. FREY: Okay. Well, I think I'll -- 15 just to maybe clarify, I don't think the panel was moving 16 in the direction of this review recommending revocation of 17 the lead NAAQS. I mean, maybe one way of looking at it is 18 that the lead NAAQS, in some ways, is at a pretty mature 19 state in this development. 20 And, I mean, we're kind of -- I guess from 21 the fact that in EPA's recommending not changing the 22 standard, we've gone through a significant process of 23 reviewing the science. And I guess the fact of the 24 evidential basis we're setting the standard hasn't changed 25 in a substantial way.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 271 1 That's not to say it couldn't change with

2 more focus efforts to collect relevant information. And a 3 number of panelist have pointed out that that seems to not 4 be happening in areas where it maybe could be helpful. So 5 it may not be the case that this is the final word on the 6 lead standard and that 1,000 years from now we'll have the 7 same standard. But I guess that's where we are right now.

8 Mike. 9 DR. RABINOWITZ: Would the chair serve, by 10 a show of hands, on actually bringing -- I just didn't 11 know the procedure, but would the chair be served? Would 12 the chair like to see a show of hands at some point during 13 the meeting whether or not -- how we rate on the question 14 on maintaining or revising the airborne standard for lead? 15 Or do you want them to read the comments? 16 DR. FREY: Yeah. That's a good question, 17 but I don't know that we vote on that, per se. 18 DR. RABINOWITZ: Okay. 19 DR. FREY: But I think it is -- in fact, we 20 knew in the sense that we do try to reach a consensus. So 21 I think the way I prefer to handle it is, if anyone 22 objects to the panel recommending -- to support EPA's 23 recommendations to advise the administrator of retaining 24 current standard, that ought to be brought up. 25 I don't think I -- my interpretation -- andMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 272 1 I haven't actually heard anyone say that. I think we've 2 heard some discussion that kind of is broader and goes 3 beyond that particular question. And if I'm wrong, then 4 speak, by all means. 5 DR. HOPKE: Yeah, that's right.

6 DR. FREY: Yeah. So -- 7 DR. HOPKE: I'm saying that we still have a 8 couple of important distributed sources of lead, aviation 9 gas and (unintelligible). Everything else beyond that 10 then -- we're never going to control the soil. And points 11 lessons were contributed through all other leads. So 12 let's start to recognize that and at least have a sensible

13 scientific discussion as to whether we continue on this 14 path forever (unintelligible). 15 DR. FREY: Yeah. And I think the -- yeah, 16 and that's really more of a policy than a science issue in 17 a sense, I think. But the -- I think -- 18 DR. HOPKE: You know, under a broad charter

19 the CASAC has --

20 DR. FREY: Yes. 21 DR. HOPKE: -- we're in a position to say

22 to the administrator --

23 DR. FREY: Yeah. 24 DR. HOPKE: -- maybe it's time for you to 25 seriously think about moving on.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 273 1 DR. FREY: Right. And I think the resource 2 implications for the agency are maybe a factor there, but 3 -- and this is actually something I wanted to not discuss 4 today, but maybe tomorrow. Is there are a few items I 5 thought -- assuming that we don't need the full morning 6 tomorrow on secondary standard -- and if we do, that's 7 perfectly fine -- but I did want to also raise the issue 8 kind of more operationally of the process that we've gone 9 through in this review cycle, given that -- you know, Sean 10 made the comment that we still get surprised that the 11 policy assessment has come out the way it has.

12 And I think if we would have seen the 13 policy assessment a year or two ago, it would also have 14 been no big surprise. What does that say about the value 15 of going through this detailed, you know, third draft ISA 16 and -- and I think -- and, honestly, there is a value to 17 that. I think there is tremendous value, and I think this 18 morning you heard a lot of locutory comments about how the 19 lead ISA is going to be an extremely valuable document to 20 a scientific community. 21 On the other hand, you know, there's a lot 22 of time and effort that goes into that. In some sense, 23 the characteristic time of the change and the information

24 basis for the lead standard is much slower than the 25 five-year review cycle. And I think we're kind of caughtMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 274 1 in that. But by statute, we must review this standard 2 every five years. You know, ideally, maybe if we were to 3 review this standard every 10 years or 15 years. I don't 4 think we have that option. 5 But we might have the option of thinking 6 about, Well, what's the process. Because the ISA is not

7 mandated under the Clean Air Act. That's sort of a 8 construct that we use, both agency and us as CASAC. And 9 it works very well, I think, when we are in situations

10 where we need to recommend revisions to the standard. But

11 does it work well in situations where we don't need to

12 recommend revisions to the standard. 13 So I don't propose to have that discussion 14 right now, but maybe tomorrow we can talk a little bit

15 about that. Because I think if we can find some 16 efficiencies, it may be helpful to all involved. 17 MS. WEGMAN: Dr. Frey, if I could just add 18 one thing --

19 DR. FREY: Yeah.

20 MS. WEGMAN: -- for consideration tomorrow. 21 The ISA, per se, is not mandated by the law, but we are -- 22 you and we are both a party to review air quality 23 criteria, and that's why we need to have the air quality

24 criteria documented in the ISA. 25 DR. FREY: Right.Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 275 1 MS. WEGMAN: So we are required by law as 2 part of the five-year review to reviewing and considering 3 the air quality criteria. So we would need some

4 version -- 5 DR. FREY: Oh, sure. Yeah. Yeah. No.

6 I'm -- 7 MS. WEGMAN: I just wanted to clarify that. 8 (WHEREIN, unintelligible due to multiple 9 people speaking at once.) 10 DR. FREY: Yeah. Yeah. I mean, we need 11 something, but -- I think we talked a lot this afternoon 12 about the role for the lead NAAQS, and that was actually 13 something I was going to suggest we talk about and we had 14 covered that. I think looking toward the letter to the 15 administrator going beyond charge questions -- or 16 actually, it is implicit in some of our charge questions, 17 issues of data and research needs. That's something we 18 are, under our charter, tasked to advise the administrator

19 about.

20 And we've kind of touched on that. I would 21 encourage you, as I said earlier, to groups to make a full 22 venue to your group discussions. And we can always pull 23 out those into maybe a separate item in the letter to the

24 administrator on advice on research and data needs. 25 We already discussed a little bit aboutMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 276 1 adverse consequences that are part of our charter to 2 address, and Dr. von Lindern will be the lead on drafting 3 some input on that. And we've heard some discussion on 4 multimedia issues, which reminded me, you know, as CASAC, 5 we also -- informally, at least -- would like to give some 6 thought to multimedia. And multimedia -- I'm sorry, not 7 multimedia, multipollutant. 8 And multipollutant may make much more sense 9 for things like asset to a knots or knots in ozone. And 10 that's something, as I understand in our agenda for the 11 ozone panel meeting this summer, we may actually have that 12 as an agenda item. I don't know that there's a clear role 13 for lead to be a multipollutant review along with other of 14 the existing criteria pollutants. And it's not obvious at

15 all that that makes sense. 16 But I just mention that as something that 17 the statutory CASAC is always interested in looking at 18 other opportunities to do things synergistically among 19 criteria pollutants. But I think here it's maybe more 20 than multimedia issue, and that then goes beyond the 21 NAAQS, even to other statutory authority besides even the

22 Clean Air Act. 23 So with those kinds of things to think 24 about plus the charge questions -- and I would recommend 25 all the groups do as much as they can while it's stillMidwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 277 1 fresh. Are there any kind of burning issues anyone wants 2 to raise before we break for the evening? 3 (No response.) 4 DR. FREY: Any questions? Clarifications 5 you need to add? 6 (No response.) 7 DR. FREY: Lydia or Deirdre, anything you

8 want to add?

9 MS. WEGMAN: Huh-uh. 10 DR. MURPHY: No. Thank you. 11 MS. WEGMAN: Thank you. 12 DR. FREY: All right. Let's see, let me 13 just review my own notes. So in sense, we've kind of 14 covered Chapter 4. We've had all the lead discussants 15 talk about Chapter 4. If there are any burning issues 16 with Chapter 4 that come up, we can continue tomorrow. 17 But otherwise, our main published agenda would be Chapters 18 5 and 6. And so we'll resume in the morning for that. 19 Any housekeeping issues?

20 MR. YEOW: No. 21 DR. FREY: Okay. So at this point, I think 22 -- officially we're not adjourning. We're just breaking

23 until tomorrow. So we will now recess until tomorrow. 24 (WHEREIN, the meeting was recessed at 25 5:37 p.m.)Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

### Page 278 1 C E R T I F I C A T E

2 STATE OF MISSOURI ) 3 ) ss. COUNTY OF JEFFERSON ) 4 5 I, Wanda L. Greenlee, a Certified Court Reporter, 6 CCR No. 1188, within and for the State of Missouri, do 7 hereby certify that the tape transcription in the 8 foregoing tape was transcribed to the best of my ability 9 and therefore reduced to typewriting under my direction; 10 that I am neither counsel for, related to, nor employed by 11 any of the parties to the action in which this tape was 12 taken, and further, that I am not a relative or employee 13 of any attorney or counsel employed by the parties 14 thereto, nor financially or otherwise interested in the

15 outcome of the action.

16

17 18 ______________________________ Wanda L. Greenlee, CCR 19

20

21

22

23

24

25Midwest Litigation Services 1-800-280-3376 scheduling-va@midwestlitigation.com 

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