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TRANSCRIPT OF PROCEEDINGS 

70 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

SCIENCE ADVISORY BOARD 

AND 

CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE 

JOINT STUDY GROUP ON LEAD 

\ PUBLIC MEETING 

VOLUM E 2 O F 2 

Pages: 1-137 ' 

Place: Research Trianlge Park, North Caroline 

Date: April 28, 1989 

O HERITAGE REPORTING CORPORATION 

122t L Stmt N.W„ Suite itt 

Washington, D.C. 2MH 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

SCIENCE ADVISORY BOARD 

AND 

CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE 

JOINT STUDY GROUP ON LEAD 

PUBLIC MEETING 

VOLUM E 2 O F 2 

PAGE S 1 - 137 

At Research Triangle Park, North Carolina. 

Friday, April 28, 1989. 

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APPEARANCE S 

Chairman: DR. ARTHUR UPTON, 

New York University Medical Ctr 

Department of Environmental 

Medicine 

550 First Avenue 

Room M-S-B-213 

New York, New York 10016 

Staff Director: DR. DONALD BARNES 

Executive Committee 

Science Advisory Board 

Members of Panel 

DR. GARY CARLSON 

Department of Pharmacology 

and Toxicology 

School of Pharmacy 

Purdue University 

West Lafayette, Indiana 47909 

DR. J. JULIAN CHISOLM, JR. 

Associate Professor 

Johns Hopkins School of Medicine 

Francis Scott Key Medical Center 

4940 Eastern Avenue 

Building G, Room 224 

Baltimore, Maryland 21224 

DR. ROBERT FRANK 

Professor of Environmental 

Health Sciences 

The Johns Hopkins School of Hygiene 

and Public Health 

615 North Wolfe Street 

Baltimore, Maryland 21205 

DR. PAUL B. HAMMOND 

Department of Environmental Health 

University of Cincinnati 

Medical Center 

Kettering Laboratory 

322 3 Eden Avenue 

Cincinnati, Ohio 45267-0056 

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DR. TIMOTHY LARSON 

Environmental Engineering 

and Science Program 

Department of Civil Engineering 

University of Washington 

Seattle, Washington 98195 

DR. IAN VON LINDERN, President 

Terragrahics Environmental 

Engineering 

121 South Jackson 

Moscow, Idaho 833843 

DR. MORTON LIPPMANN 

Professor 

Institute of Environmental Medicine 

New York University Medical Center 

Tuxedo, New York 10987 

DR. KATHRYN R. MAHAFFEY 

National Institute of Environmental 

Health Sciences 

University of Cincinnati Medical 

Ctr. ML-56 

3223 Eden Avenue 

Cincinnati, Ohio 45267 

DR. PAUL MUSHAK 

Consultant and Adjunct Professor 

University of North Carolina 

Chapel Hill, North Carolina 27514 

DR. MICHAEL B. RABINOWITZ 

Investigator^ 

Marine Biological Laboratory 

Wood's Hole, Massachusetts 02543 

DR. ELLEN SILBERGELD 

Environmental Defense Fund 

1616 P. Street, N.W. 

Washington, D. C. 20036 

DR. BERNARD WEISS 

Division of Toxicology 

Department of EHSC 

School of Medicine 

University of Rochester 

Rochester, New York 14642 

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DR. JEROME J. WESOLOWSKI, Chief 

Air and Industrial Hygiene 

Laboratory 

California Department of Health 

2151 Berkeley Way 

Berkeley, California 94704 

Environmental Protection Agency 

Staff Participants 

DR. LESTER D. GRANT 

DR. J. MICHAEL DAVIS 

Mr. JOHN HAINES 

Mr. BRUCE JORDAN 

Mr. JEFF COHEN 

DR. JIM COGLIANO 

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1 WELCOME AND ADMINISTRATIVE NOTES 

2 DR. BARNES: If we can gather ourselves around the 

3 table, we'll begin, so we can finish. 

4 We're convening the second session of the Work 

5 Study Group on Lead for the Science Advisory Board of the 

6 USEPA. 

7 We met yesterday and talked about earlier issues 

8 related to the Clean Air Subject Advisory Committee and 

9 their review of the staff paper of the Office of Air 

10 Quality Planning and Standards. 

11 Today the session is going to be chaired by Dr. 

12 Art Upton, who is a Co-Chair of the Joint Study Group on 

13 Lead of the Science Advisory Board. He is also the Chairman 

14 of the Environmental Health Committee of the Science 

15 Advisory Board. And he comes to us as a former head of the 

16 National Cancer Institute. 

17 The agenda for today's activities are available on 

18 the side, in somewhat cryptic fashion. We have a series of 

19 speakers from EPA. We have one public comment that we're 

20 aware of, and we have a series of issues the Chair will call 

21 to our attention in a few moments. 

2 2 By way of administrative work, a sheet is going 

23 around to members of the Study Group, asking yon when your 

24 flights are scheduled to leave. We need to coordinate some 

25 semblance of order in transferring you tb the airport. 

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6 

1 With, unless there are other administrative details to deal 

2 with at this point, I'll turn the meeting over to Dr. 

3 Upton. 

4 DR. UPTON: Thank you very much Don. You'll. 

5 recall we reviewed the charts from the Study Group 

6 yesterday. Let me just review it one more time to sort, of 

7 set the stage for discussion we'll have this morning. 

8 First item in the chart was to review the weight 

9 of evidence, classification of lead and lead compound in 

10 carcinogens. Then you'll recall, we addressed that issue on 

11 the 30th of March, heard again an update yesterday by Dr. 

12 Cogliano. 

13 The second item in the chart was evaluate the 

14 supplement to 1986 addendum, the 1986 Air Quality Criteria 

15 Document for Lead. The document was entitled "Review of the 

16 National Ambient Air Quality Standards for Lead" The text 

17 consisted of scientific and technical information and we 

18 discussed that yesterday. 

19 The third item, to review the consistency of the 

20 proposed regulations for lead in drinking water. Tlie 

21 previously reviewed and approved data studies and analysis. 

22 And fourth, other relevant issues which may be 

23 identified, by the Joint Study Group, CASAC, or the HAM 

24 Executive Committee. 

2 5 So, -I think today we're moving into the 

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7 

1 consideration of the lead related exposure and health 

2 effects issues, and cut cross organizational lines within 

3 the agency. 

4 And the first presentation this morning is by Jean 

5 Briskin from the Office of Drinking Water. 

6 DR. BRISKIN: Good morning. I'd like to go over 

7 with you today a little bit about the "Safe Drinking Water 

8 Act" since it's very different than the "Clean Air Act" and 

9 explain a little bit about how we set standards, under that 

10 law. Talk about the proposed goal for lead in drinking 

11 water, which is a non-enforceable goal. And then talk about 

12 the enforceable standard in each of those cases. 

13 I'll be going through places where we have a Jot. 

14 of problem using the air quality criteria document and the 

15 OAQPS staff paper for assessments of health effects Irom 

16 lead and health risks from exposure to lead. 

17 Under the "Safe Drinking Water Act" we set 

18 standards for a two part sequence. First, we set a maximum 

19 contaminate level goal. This is a concentration of lead in 

20 water, which is a non-enforceable health based goal for 

21 drinking water. The more I talked about setting a standard 

22 with no known and anticipated adverse effects and I'U. be 

23 getting into health effects about that. 

24 Second step after having set a goal, is to set an 

25. enforceable standard called " The National Primary Drinking 

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n 

1 Water Regulation" and we're supposed to set that 

2 enforceable standard as close to the goal as feasible for 

3 large water systems. This is a technology based standard. 

4 We proposed the standards in August of 1988. We are working 

5 right now on finalizing those standards. 

6 The agency has a policy which has been established 

7 through four administrators on studying maximum contaminate 

8 level goals at zero for substances which are rated as class 

9 A or class B2 carcinogens. 

10 It's been a policy that has been upheld in court 

11 when challenged recently by people on both sides. And part 

12 of the rationale for that is the idea of protecting against 

13 things where there maybe no threshold. 

14 In the case of cancer, that may or may not be the 

15 case, but with our inability to look for a threshold and 

16 actually see a threshold, at least, that we're confident in. 

17 That has led us to also support the national contaminate 

18 level of .0. 

19 Our policy goal is to minimize the exposure of 

20 lead to all sources. We see drinking water as being one 

21 contributor towards total exposure. And we want drinking 

22 water to contribute a minimal amount towards total expusur1-', 

2 3 because people in the US today have blood lead levels that 

24 are associated with adverse health effects at the higher <-"MIH 

25 and there are many people who have blood lead levels who are 

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.1 near the range of possibly experiencing adve_:se health 

2 effects already. We see that drinking water should, as a 

3 goal, as a health-based goal, contribute as little as 

4 possible to existing body works. 

5 I mentioned the classification of lead as a B2 

6 probable human carcinogen. This group has reviewed that and 

7 I believe concurred on that finding. And that reason alone, 

8 one would ask, is sufficiently the administrator's policy 

9 for the last four administrators to establish maximum 

10 contaminate goal of zero for contaminates. 

11 And then, as I got to the occurrence of low level 

12 exposure effects, for which we can't really identify a 

13 clear threshold, for which there are no risks of adverse 

14 effects. And we believe we've been consistent with the "Air 

15 Quality Criteria Document" addendum and supplement in our 

16 characterization of that effect of -- we think that we have 

17 interpreted that properly. 

18 Our enforceable standard is something else again. 

19 We have two possibilities for controlling lead in drinking 

20 water. One is called a maximum contaminate level, that's a 

21 performance standard. We specify a concentration of lead in 

22 water that the water supplier must meet. 

23 The other possibility is a corrosion control 

24 treatment technique which is an operating standard. In this 

25 case we tell the water supplier; install a certain type of 

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1 treatment to control this contaminate, and if you install 

2 that type of treatment, no matter what level you get In the 

3 end we expect it to be much lower that what we started with 

4 would be considered sufficient. 

5 Our enforceable standards are technology based. 

6 They need to be feasible for large water suppliers. 

7 when we set the standards, it is a technology 

8 based standard, it is as close to the law as we can get. It 

9 is not immediately a health based standard. But when 

10 evaluating alternative standards to see how well they vary, 

11 we gad a set for equally feasible standards for large water 

12 systems. To see how close to that goal we get, you might 

13 evaluate in terms of the non-cancer health effect, because 

14 for a enforceable regulations, we agree with the Air 

15 Office's evaluation as to known cancer health effects are 

16 our greatest regulatory concern. 

17 And so we would evaluate the options that we 

18 propose in terms of numbers of children and forces of 

19 children whose blood lead levels would remain above, would 

20 be dropped below a blood lead range of concern, and until 

21 now the agency could playing with the range of 10-15 

22 micrograms per deciliter, which is consistent with the I.'Mir, 

2 3 Criteria Document Supplement. 

24 Here the agency is directed by a work group to go 

25 in a different range and thus so that we would of course 

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1 adjust our analysis. 

2 So to summarize, the maximum contaminate goal is a 

3 nonenforceable health base goal. It's not a goal for blood 

4 lead. It's a goal for drinking water concentrations. And 

5 it's only purpose really is to serve as a backstop. That 

6 is the minimum standard that we would set. 

7 There is then a technology based standard which we 

8 would evaluate in terms of non-cancer health effects, when 

9 we're looking at different options. 

10 There are a limited number of copies of the 

11 Federal Register Notice available, that I brought with me 

12 that describes our proposal in detail and I can point to 

13 page numbers in the preamble that explains our assessment of 

14 health effects, our rationale for the maximum contaminate 

15 level goals, and our discussion of how we would calculate 

16 benefits of any proposed alternative standards, and I'd be 

17 happy to answer any questions. 

18 DR. UPTON: Thank you Dr. Briskin. Comments? 

19 Questions? 

20 DR. CARLSON: Yes. Isn't the peak goal involved 

21 in the lead, the ability to measure the lead? 

2 2 DR. BRISKIN: When we set an enforceable standard, 

23 we consider how close to the goal, water suppliers oan got 

24 the water. When we use a maximum contaminate level to 

25 regulate, the maximum contaminate level- needs to be 

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12 

1 measurable and to, and so one of the technical feasibility 

2 factors that we consider is can be water supply measure, 

3 the contaminated water. To make an assessment of that, we 

4 come up with the notion of a practical quantitation limit 

5 for PQL. The practical quantitation limit is the level not 

6 the detection limit, but rather the level where we are 

7 confident we are able to quantify the amount of lead in 

8 water, not just tell that it's there, but we are very 

9 confident that five parts per billion of ten parts per 

10 billion as opposed to some other level. 

11 That's a policy based analysis and that's one of 

12 the technical factors that we consider. 

13 DR. CARLSON: That will probably play a role in 

14 the lead level. 

15 DR. BRISKIN: Or a maximum contaminate level would 

16 be one of the things that we would consider. 

17 DR. UPTON: Ward. 

18 WARD: You've made' it very clear that you're 

19 talking about the concentration as the purveyor of water as 

20 to the -- does that mean that the water sample remains in 

21 the stream? Obviously one of the concerns about lead, Is 

2 2 the aging lead solder in the homeowners or apartment house 

23 supply system. And obviously you don't have any regulatory 

24 authority over that so, -- where does regulatory authority 

25 stop, when you're considering lead in the drinking water, 

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1 and what do you do about depositories that lead gets in the 

2 water, between the suppliers' responsibility and the actual 

3 path? 

4 DR. BRISKIN: Under the State Drinking Water Act, 

5 we believe that we can hold water suppliers responsible for 

6 things under their control. 

7 Although the water supplier can't directly 

8 control the existence of lead quantity inside his own house, 

9 they can control the existence of lead in plumbing under 

10 their controlled water mains distribution systems. And they 

11 can control the corrosivity of the water, which is an a.1.must 

12 equally important factor in determining lead levels that we 

13 tap. 

14 Under our proposed rule, we propose a two part 

15 standard for the enforceable part. We propose that water 

16 suppliers need a maximum contaminate level of 5 parts per 

17 billion, measured at the entry points of distribution so 

18 that in the rare case where there might be lead 

19 contaminating the source, the water supplier would be 

20 required to remove the lead from that source, before 

21 streaming the water. 

2 2 Or trying lead as a corrosion by-product, you 

2 3 propose a treatment technique, so that the water supplier 

24 would be required to minimize the corrosivity of the water 

2 5 towards lead. If, at tlie tap, lead exceeded an average <>l 

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1 10 parts per billion or if the pH of the water was less than 

2 8, pH being a surrogate for the corrosivity of the water. 

3 Right now we're re-evaluating that issue and 

4 possibly considering many of the alternatives that we asked 

5 you to comment on among them and that is the outlet tap 

6 which would leave the water supplier free to choose the 

7 method of treatment to meet the standard at tlie tap. 

8 DR. UPTON: I think, Dr. Hammond. 

9 DR. HAMMOND: Do you have the authority to control 

10 the pH of the water in the reservoir? 

11 DR. BRISKIN: What we see the water supplier doing 

12 is controlling the corrosivity of the water that they 

13 deliver. Are the water suppliers free to do that in any way 

14 they choose? I believe that it wouldn't be recognized as a 

15 good engineering practice to control the pH in reservoir --

16 DR. HAMMOND: (Interposing) Well let me — 

17 DR. BRISKIN: — as far as the drinking water quality 

18 goes. 

19 DR. HAMMOND: At the point of delivery, wherever that 

20 is. 

21 DR. BRISKIN: Yeah, the, we prefer a treatment 

2 2 technique where the water supplier is able to choose the 

23 best combination of corrosion control practices that have 

24 found for water characteristics. What we found is that 

25 water suppliers vary immensely across the country. Water 

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1 chemistry is rather complicated as far as the varied 

2 equilibrium with the carbonate systems and so forth. The 

3 water suppliers find themselves balancing corrosion control. 

4 with concerns about — and with making sure that each 

5 section is sufficient to assure good microbiological 

6 qualities in water. 

7 And so we see pH adjustment, operating adjustments, 

8 and use of corrosion inhibitors, either alone or in 

9 combination, as being the general strategy. It's up to each 

10 local water suppliers to determine the combination that 

11 will, for their particular water quality and lead levels at 

12 the tap. 

13 DR. UPTON: Dr. Wesolowski and then Dr. Silbergeld. 

14 DR. WESOLOWSKI: I thought I heard you say that 

15 along the 5 parts per billion at the distribution source 

16 with 10 parts per billion at the tap, so what is the 

17 rationale for developing lead level exposure with different 

18 numbers? 

19 DR. BRISKIN: In the case of the removal of lead 

20 from water, we find that the technology data will used on 

21 something like reverse osmosis or in exchange is able to 

22 remove lead down to the practical quantitation which, in 

2 3 this case, will be five parts per billion. So that's as 

24 close as -- to that goal as zero, which is feasible. 

25 In the case of the corrosion control treatment 

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1 technique, the average of 10 is a trigger for treatment. It 

2 is not an enforceable standard. It's a indication of the 

3 construction lead coming out of peoples' water that the 

4 corrosivity needs to be controlled. 

5 The way that the system would work is, the water 

6 supplier measures lead at the tap among high risk houses, 

7 houses that have new lead-solder which has been shown to 

8 produce more lead than older lead solder or lead plumbing or 

9 lead service connections. If the average among those high 

10 risk taps, not just any value was greater than 10 or pH was 

11 less than 8 had more than five percent of the taps, then the 

12 water supplier would be required to apply to the state for 

13 approval of treatment. The treatment plan is an enforceable 

14 schedule with steps that the water supplier will take to 

15 minimize or prove to the state that it has already minimized 

16 lead levels at the tap. In some cases the minimum might be 

17 much lower than the average of 10. But in other cases, due 

18 to the characteristics of the local plumbing, it may not be 

19 possible to show the water supplier to meet an average of 

20 10. What the firm needs to show is that a water supplier 

21 has minimized the lead levels at high risk taps, whatever 

22 that minimum is. And the water supplier would probably 

23 start off doing a pilot format type of group study In terms 

24 of type of treatment in that adjustable scale to show that 

25 things are operating efficiently. 

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1 DR. UPTON: Dr. Silbergeld and Dr. Chisolm. 

2 DR. SILBERGELD: I guess what's kind of worrying 

3 is as you — from what you've said Jean, and thinking about 

4 this, it's hard to figure out where there really is a clear 

5 signal in terms of the number being given to guide action. 

6 Because it also seems to be generating a kind of water 

7 treatment system, which is never — at no point is there 

8 really a backstop that says at this level of lead 

9 concentration something has to happen. Analogous, say to 

10 what you might do at a super pump sight, where at some point 

11 people step in and provide alternative water supplies, as 

12 the most drastic and dramatic remedy. So, I'm a little 

13 concerned about that from the scientific point of view. 

14 What worries me here is that, obviously you are caught to, 

15 into a problem where there is a private individual 

16 component, which relates what goes on inside peoples' 

17 houses. Which is probably up to lawyers to decide what we 

18 can and cannot do. 

19 But just from a scientific public health aspect, 

20 what worries me here is that that's providing a barrier to 

21 information. It may be very important for public health 

22 people, and for individual physicians taking care of 

23 children, to know what the sources of lead exposure are. 

24 If a pediatrician has a child who comes in with a 

25 blood lead of 20, and the house doesn't have any lead pain! 

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1 in it, the house is not near a lead smelter, there would 

2 obviously, if the pediatrician takes to heart the 

3 recommendations of the American Academy, he or she is going 

4 to be looking for that preventable source, because that's 

5 the victim of the academy. Go find that source and 

6 intradict between the child and the source, because there's 

7 no therapy to be given here. 

8 And what you're doing by this system, it seems to 

9 me, what worries me, is making it very hard for that 

10 pediatrician, or for the public health department, on a 

11 larger scale, to get a sense of what, if drinking water 

12 might be the source for that child or for groups of children 

13 by this very elaborate averaging technique and by staying 

14 away from, really, what Ward said, which is we all know that 

15 the lead is the problem at the tap, and we know where we're 

16 going to find it is by sampling at the tap, and that a 

17 system that isn't built towards the primary purpose of 

18 finding out what's going into people from the tap, is not 

19 going to be very useful for public health planning or for 

20 individual management. 

21 We have to site all the legal and other problems 

22 with what you guys have been proposing. This is what 

23 worries me. 

24 DR. BRISKIN: Let me address that with recent 

25 answers. One is to tell you about a portion ot the proposal 

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1 which I haven't gone over yet, which is on public education 

2 proposal. Second, let me tell you a little bit more about 

3 the monitoring system that we proposed, and third, let me 

4 tell you about, sort of the alternatives which we're 

5 considering. 

6 DR. SILBERGELD: Well, with the public education 

7 proposal, I can tell you it's sort of like a, people get 

8 the reaction from that at EDF. It is a disaster. And I 

9 hope you're not using that as some, that you have any sense 

10 that that's providing any public health protection. 

11 DR. BRISKIN: Let me explain what it is, because 

12 I don't know that everybody here knows what it is. 

13 On route to the proposed approach, we were 

14 concerned that if a water supplier did ever think that is 

15 was under their control to minimize corrosivity, that there 

16 would still be taps that would have too much lead coming out 

17 of them. We weren't comfortable with that, so what we 

18 proposed is that if more than 5% of the taps were found to 

19 have more than 20 parts per billion of lead, again these 

20 high risk morning first draw samples. Then the water 

21 supplier would be required to conduct an on-going publio 

22 education program. And the public education program would 

23 need to be targeted at high risk areas, so the water 

24 supplier would have to go out and find where lead levels 

25 were high in the community. And offer information to people 

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20 

1 on how they could further reduce their exposures. The 

2 presumption would be that the water supplier has already 

3 done what they could do to bring the lead levels down. 

4 We weren't sure how effective public education 

5 would be, and so we're sponsoring a public education pilot 

6 project here in Raleigh, North Carolina, that's been going 

7 on since August. We try to take a baseline reading of what 

8 peoples' knowledge about lead in drinking water was, and 

9 what they were doing about it. With the city of Raleigh, 

10 we've developed materials to explain to people that it's 

11 very important that one have knowledge about the water. 

12 We've worked with the city and they are improving their 

13 corrosion control treatment as a part of the steps they've 

14 taken. We can honestly say that they've minimized the lead 

15 levels at the tap at the same time they're telling 

16 consumers, that the consumer also needs to take action. 

17 That will be conducted — well, the city is 

18 conducting a post-test to see if there's been any change in 

19 the knowledge of the people that lives in the community or 

20 in their actions that they were taking to protect 

21 themselves. 

22 The city has offered free water testing t<> 

2 3 anybody served by the city water department and that has 

24 helped identify areas where there were excessive lead levels 

25 at the tap, and we're hoping that, through our testing 

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21 

1 procedure, we'll be able to see to what extent public 

2 education can be effective. And we would plan to modify any 

3 proposal, when we go final, based on our findings from that 

4 study. 

5 So, we're taking a look at it. We don't know 

6 that public education can be effective, but we're trying to 

7 see how effective it might be. 

8 DR. UPTON: Dr. Chisolm. 

9 DR. CHISOLM: First, Dr. Silbergeld, she speaks of 

10 the ideal facts in pediatrics and I would say that there 

11 isn't any answer. Cut the lip. 

12 DR. SILBERGELD: In this case it might be expected. 

13 DR. CHISOLM: You recall in Stockton, that they 

14 first recognized sodium hydroxide, but when they found that. 

15 they tested the water at different -- at greater and greater 

16 distances from the water treatment plant, the water was 

17 already close to the plant, but the pH had dropped at the 

18 end of the plant, I think they had to add phosphate to it. 

19 So my question to you, do you take this into account 

20 in your sample of -- where you're dealing with highly 

21 corrosive particles? My second question is what role does 

2 your office play in the enforcement of the use u I: low-I.e..id 

2 3 solder? I suspect that there are many pounds of 50* lead 

24 solders still out in the field. What role do you play iu 

25 that? 

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1 DR. BRISKIN: In the case of the hyper-capacity 

2 of the water supplies. The case where you're describing the 

3 water as not well buffered, usually what the system is using 

4 is something like sodium hydroxide to increase the pH, it is 

5 not well buffered, in that the pH drops off again after a 

6 certain distance. The City of Boston is connected with a 

7 similar problem and what they've done is to install pumping 

8 stations further along downstream. To further boost the pH 

9 alternative, would be to add carbonate as a buffer to the 

10 system of -- or, as you suggested, add a corrosion barrier. 

11 It would be up to the state to judge that the water supplier 

12 has minimized lead levels at the tap by controlling 

13 corrosion. So, they would have to work with the water 

14 supplier and be convinced by the water supplier that what 

15 had been installed was adequate to take care of the problem 

16 that you're raising. That's the case that's pretty well. 

17 known, I believe, throughout the Water Supply Committee. 

18 On the lead solder ban, in 1986 Congress enacted 

19 a ban on the use of lead solder, including water supplies, 

20 and they explicitly said that the states are to enforce that 

21 ban. So right now it is illegal to sell lead solder that has 

22 not been labeled 'Not Suitable for Water Use' and the 

23 states have been adopting tiieir own bans. We have been 

24 monitoring that adoption of bans on, including solder, flux 

2 5 and lead pipes. 

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1 Some states are very aggressive at enforcing the 

2 ban. Others are less so. For example, some states will use 

3 plumbing inspectors. They've adopted a ban for plumbing 

4 codes. And there are housing inspectors, plumbing 

5 inspectors who go out and before they approve new plumbing 

6 in a housing development they'll go in and test it to be 

7 sure that lead free soldering has been used but the 

8 enforcement capabilities spread out to the different states 

9 in housing, plumbing or Department of Health and it is this 

10 law that allows the states to adopt different approaches. 

11 The penalty for states not own enforcing the ban is that EPA 

12 would withhold up to 5 — 5% of the federal grants that we 

13 give the states for implementing the 'Drinking Water 

14 Program'. I know of at least one state that is in that 

15 dilemma now. Their Legislature had to act to enact a ban. 

16 So even though the federal ban is in place, the state 

17 legislature has to enact enforcement procedures quickly 

18 enough to hope that they'll have them completed. 

19 DR. UPTON: I see three hands up. Dr. Mushak, 

20 Dr. Carlson, Dr. Weiss, and Dr. Rabinowitz. Dr. Mushak. 

1 DR. MUSHAK: Beyond this business of the number 

22 of samples to decide upon. Is vital role making a little 

23 better on that score, than what was proposed? 

24 DR. BRISKIN: -- uhm. 

25 DR. MUSHAK: You know a number of us•criticized 

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2 4 

1 this program during Congressional testimony. It seems 1 i.k^ 

2 it's a little ridiculous to have the same number of, 

3 absolute number of samples for the City of New York, that 

4 has a horrendous mix of tide-like water and low-like water 

5 compared this contract with the equivalent with what you 

6 would get with a city like Charlotte or Durham, North 

7 Carolina. 

8 DR. BRISKIN: And we proposed a tiered approach to 

9 monitoring where large systems would take more samples, 

10 small systems would take fewer. We proposed that the larger 

11 systems would take 50 samples per quarter, and that Hie 

12 smallest systems, those that serve less than 500 people 

13 would take 10 samples every 5 years. We are re-evaluating 

14 the long term approach. We've gotten comments in both 

15 directions from our many amateurs, some commenting that 

16 there weren't enough samples there to adequately tell what's 

17 going on, and others saying that the number of samples that 

18 we were requiring were outrageous, too burdensome and too 

19 expensive. So we're having to come up with a monitoring 

20 scheme, that adequately identifies our lead problems and 

21 corrosion control treatments that have been put in place. An 

22 yet it is feasible for small water systems to do it. 

2 3 DR. MUSHAK: Cause I would find it hard tu 

24 believe that you could sample the City of New York quite 

25 perfectly, lead water-from 50 samples. Any half intelligent 

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1 human being could figure out some way to get 50 samples 

2 that would make his life simple and have low lead --

3 (Reporter: I can't hear you.) 

4 I hope that because of the vary large water system 

5 that the final rule making will take some percentage of the 

6 task, rather than 50%. 

7 DR. UPTON: Dr. Carlson. 

8 DR. CARLSON: Obviously, Jean came to the Drinking 

9 Water Subcommittee Group with this lead originally. And we 

10 had some questions about the sampling. We had a number of 

11 questions. One of the things being the worst case, su your 

12 argument doesn't hold. 

13 In other words, according to these directions, you 

14 have to look at the worst case samples. But that was our 

15 objection, which is just the opposite of, perhaps, what you 

16 feel. 

17 We had some problems with it as what it meant and 

18 Dr. Silbergeld is not here and I was going to agree with her 

19 that one of our concerns is that from the public health 

20 standpoint, both of these cases are identified through more 

21 than that. I know that's something you're concerned about, 

22 it's not something that is there to meet the letter "f the 

2 3 law. The law right now is 50 parts per billion. 

24 DR. BRISKIN: The current standard is 50. 

2 5 DR. MUSHAK: So this is controversial. And we also 

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1 had some problems with the analysis of all the data because 

2 you can't go back and repeat at those same places to see if 

3 their corrosion control is working. We had some questions 

4 as to whether that was reasonable. We also had some 

5 problems with statistical analysis that was confused with 

6 percentages. But I think a lot of that is being worked out. 

7 I mean, we made comments that Jean got, I think 

8 she told me 3,000 public comments or something like this to 

9 deal with, and I'm really glad about flexibility, because 

10 it's one of the things in the treatment, as Jean says, a lot 

11 of the source waters are going to be having different 

12 problems and the ability of the water purveyor to do what he 

13 has to do, dependent upon the water sources, which is really 

14 important, I think. It's a major step forward. 

15 DR. UPTON: Ms. Levine. 

16 DR. LEVINE: I think my hand is — (Laughter) 

17 DR. UPTON: Dr. Rabinowitz 

18 DR. RABINOWITZ: Well, just a question about the 

19 authority of the EPA in these matters. I assume you had no 

20 authority over private wells. 

21 DR. BRISKIN: That's correct. We only regulate 

22 water supplies that serves 2 5 or more people, ur 1.5 -M mor--

23 services. 

24 DR. RABINOWITZ: So, I'm just thinking, In -mr area 

25 we have apartment houses that have their own private wells. 

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2 7 

1 Some of these you might have authority over, some you might 

2 not. 

3 DR. BRISKIN: That's correct. 

4 DR. RABINOWITZ: We have a number of cases of lead 

5 poisoning from situations like this. 

6 DR. BRISKIN: Yeah. We, we've been trying to 

7 publicize the issue of lead in drinking water and probably 

8 not just the rule and it's a difficult task to keep 

9 drinking water in perspective with other sources of lead, 

10 because often it's not the major sources of exposure to lead 

11 but it can be an important contributor. 

12 DR. UPTON: Dr. von Lindern. 

13 DR. VON LINDERN: Can you tell us what blood lead 

14 distribution you projected 20 parts per billion? And what 

15 assumptions you used in calculating that. 

16 DR. BRISKIN: At the 20 parts per billion of lead and 

17 water? I can't because with the standard, let's say we were 

18 to set a standard of 20 parts per billion. If we set a 

19 standard of 20 parts per billion, then we would presume that 

20 the standard depends upon not just what the number is, but 

21 how you measure it. So, for example, if you set the 

2 2 standard 20 parts per billion and require every single tap 

23 to meet that 20 parts per billion, then, from there, l roul.d 

24 project, although I don't have the numbers with me today, "f 

25 what the expected change in blood lead distributions might 

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2 8 

1 be for current, assuming that 1 could get a reasonable 

2 picture of existing water lead distributions, which I'm not 

3 sure I have. 

4 I can make some estimates based on a couple of 

5 different data bases that are available to us, but we have 

6 no real verified database on water lead levels in the U.S. 

7 today. 

8 There's a complication however, which is that, if. 

9 we were to set a maximum contaminate level standards, which 

10 is what I think we were talking about. The standard is just 

11 not the number, but how you measure it. So if we were to 

12 set a standard that would require 95% of the taps to meet 20 

13 parts per billion, we would be silent on the other 5'fc. We 

14 can, again, attempt to make estimates of changes of blood 

15 leaded conditions based on the distribution of water lead 

16 levels. Remember that when the water supplier puts in 

17 corrosion control treatment, he aims at 20 parts per 

18 billion. Sometimes they're going to get lower than that 

19 just because that's how the corrosion control treatment 

20 works. They're not just going to stop at a point when they 

21 get one tap there. And it's the difficulty in predicting 

22 the post-regulation water lead distribution, which we can 

23 make estimates of. We can run that off our definition of our 

24 monitoring scheme. And then provide that with the data with 

25 holes in it on the existing water lead distribution. So, 

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2 9 

1 the short answer is, I don't know. 

2 DR. UPTON: Tom. 

3 TOM: This study group is suppose to be looking 

4 at the consistency of regulations between different programs 

5 within EPA. I understand from your presentation that the 

6 Water Program is consistent with the 10-15 micrograms per 

7 deciliter that you talked about. Maybe, I'm following up on 

8 the Dr. von Lindern's question. We're trying to see how 

9 that consistency is arrived at. if the air programs moved 

10 to 5 micrograms per deciliter, would the current Office of 

11 Water position, have to change in any way to maintain 

12 consistency? 

13 DR. BRISKIN: What we would do is evaluate the --

14 our plans are to take a look at existing blood lead 

15 distribution, and make estimates of the existing water lead 

16 distribution. 

17 You saw methods that had been developed by Alan 

18 Marcus to look and see what the change in water lead 

19 distributions might mean on changes in blood lead 

20 distributions and then estimate numbers of children who 

21 remaining or changed below certain blood lead levels ol 

22 concern. 

2 3 And if the agency goes with 10-15 as the blood 

24 lead levels of concern, we would forget numbers of children 

25 brought below those levels. 

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JO 

1 If the agency goes with 5 micrograms pei 

2 deciliter, we would look at the number of children changed. 

3 And because of possible irregularities in the distributions, 

4 that might effect our assessment of the relative stringency 

5 of different options for monitoring and for enforcing the 

6 standards. 

7 DR. UPTON: Dr.. Carlson. 

8 DR. CARLSON: Yes. I don't know Jean. I don't 

9 want to put words in your mouth about what numbers you're 

10 going to use, but Dr. Marcus is here and I'm reading in the 

11 brown book here about a slope of 0.161 micrograms per 

12 deciliter per microgram of lead in the water. 

13 So if you multiply 20 times that you get about 

14 3.2. Okay, micrograms per deciliter to blood at the 20. 

15 But remember, 20 is the high number, we're really trying to 

16 get one closer to 10 as an actual, alright. 

17 DR. BRISKIN: Well, you have to distinguish, I 

18 think, between individual water lead level and adding on to 

19 their — 

2 0 DR. CARLSON: (Interposing) Right. 

21 DR. BRISKIN: -- exposure from non-drinking water. 

22 DR. CARLSON: This would be the contribution due 

2 3 to the water. 

24 DR. BRISKIN: That would be the contribution due 

25 to the water for the people that that provision apply to. 

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1 DR. CARLSON: Right. 

2 DR. BRISKIN: We've been reevaluating what the 

3 appropriate coefficients might be at the different water 

4 lead levels and for children of different ages. 

5 DR. CARLSON: But is that the way to calculate. 

6 My concern is we've seen one method here in OAQPS of 

7 calculating intakes and turning those into estimated blood 

8 lead levels and distributions. 

9 Do you do that in a 'Drinking Water Program' and if 

10 so, what assumptions do you make about what age you 

11 calculate that at, what baselines you use? 

12 DR. BRISKIN: We've been looking at two year olds 

13 as being the most susceptible to lead in drinking water and 

14 we've also not been using the biokinetic uptake model. That 

15 has not been calibrated for drinking water, so we are using 

16 the same studies and data that go into that model and 

17 operate with blood lead water levels and conversion factors 

18 using the same studies that the same studies that the 

19 biokinetic uptake model has available to it for looking at 

20 non-drinking water lead contributions so that we can parse 

21 out a drinking water change. Roughly what you've got is a 

22 distribution of a blood lead levels which shouldn't l»--

2 3 normal. 

24 And some part of that distribution is through 

25 drinking water and at each.point you've got varying amounts 

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1 that are drinking water contributors. Down here with high 

2 blood lead exposures, you've got relatively small 

3 contributions from this water here. At lower blood lead 

4 exposures, you've got relatively large drinking water 

5 contributions and so what we're doing is talking about 

6 changing the distribution of the drinking water contribution 

7 to total blood level and seeing what effect it has on the 

8 distribution of blood leads across the country. There are 

9 some papers that describe the method for doing that, that Al 

10 Marcus wrote for us, that I can get you copies of that go 

11 into a lot of detail on how those calculations might be 

12 done. 

13 DR. UPTON: I see a lot of hands up. Ellen and 

14 Dr. Mahaffey. 

15 DR. SILBERGELD: What you've just said Jean, I 

16 really goes to the heart of the scientific basis of what 

17 you're trying to do, and as you point out, there is a lot 

18 that is not known. 

19 I guess there are two concerns that occur to me 

20 right now. One of course, I'm fundamentally -- what exactly 

21 is your thinking about what you've just drawn there and to 

22 what extent do you know that to be the case? And how COD 

3 you encompass all the different types of circumstances which 

24 might have relatively different distributions of 

25 contributions? 

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3 3 

1 But the two fundamental questions I have are first: 

2 off, maybe this question has to be deferred until the end 

3 but, if the agency adopts a certain blood lead level as a 

4 goal, and I think it's very laudatory that the agency is 

5 finally moving to that, but you're having a integrated over 

6 all public health goal which is independent of media, 

7 independent of source. 

8 To what extent, however, are your different risk 

9 assessments still built around meeting that goal, on a 

10 pathway by pathway, source by source method? 

11 We've heard a great deal about the continued 

12 contribution of air lead through direct and indirect 

13 pathways to blood lead, what margin does that give you to 

14 allow an additional contribution from drinking water. I 

15 suggest certainly much less than 10 or 5. It's a very snia 11 

16 amount be given, if we look at the current distribution of 

17 blood leads, and look at the sources, both from past uses 

18 which we're going to hear from next, I guess, with the 

19 Office of Solid Waste. The on-going uses and the air 

20 contribution which still, is still present and still very 

1 large, when you add up all its pathways. I'd suggest that 

2 2 you only got about -- Let's say if 10 is your goal, you 

2 3 maybe got 2 micrograms per deciliter for the contribution 

24 from drinking water, which is radically different from what 

2 5 you've been up to and what the environmental health 

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1 committee has been up to and needs to be re-thought. 

2 And then the other issues is, I think, here you 

3 have even less justification than the Air Document has in 

4 using two year olds, as your population of concern. 

5 First off, one might say that the infant from 0 to 

6 18 months has much higher portion of its diet may include 

7 drinking water. If you use the contribution of water to 

8 make formula, water in food processing, as well as just 

9 straight water to be fed to babies, which is now recommended 

10 by most pediatricians. 

11 And as well, I think it reopens the issue of fetal 

12 lead exposure, because of the very great propensity of the 

13 ingestion of lead by drinking water to be translated 

14 directly across the placenta to the fetus. So that I don't 

15 know why you're going with two year olds, in terms of 

16 exposure, as well as sensitivity or this notion of 

17 responsiveness that you all have. I'm most concerned about 

18 the allocation of the total, quote, allowable level of lead 

19 in blood to drinking water. 

20 What's your estimate of the contribution of 

21 everything but drinking water to blood lead, in whatever 

22 you're talking population is. So what have you got left to 

2 3 play with? 

24 DR. BRISKIN: I misspoke myself when I talked 

25 about two things. Some of the coefficients that we looked 

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1 at have been developed for infants. Those in the study 

2 looked at --

3 DR. UPTON: Age? 

4 DR. BRISKIN: Infants fed formula made of 

5 drinking water versus infants where lead was measured in 

6 form of their B.M.s. 

7 DR. CARLSON: Do you have the answer. 

8 CHRIS DEROSA: Yes. Six and one-half months. 

9 DR. BRISKIN: The second question — 

10 DR. MAHAFFEY: But are they your target 

11 population for "risk assessment"? 

12 DR. BRISKIN: We have, we need to consider two 

13 things. One is the sensitive person and that in this case 

14 because of the high proportion of diet possibly made out of 

15 water and formula would be in the infants. The second is 

16 the place where he — the person is consuming a lot of water 

17 and the older, we're talking total a greater volume of 

18 water. 

19 DR. MAHAFFEY: But, not for body weight. 

20 DR. CARLSON: I think the original thinking was 

21 that two year olds had higher blood lead levels, to begin 

2 2 with, from other sources of water. I think that's where th<--

23 Drinking Water Office began. 

24 DR. MAHAFFEY: I think if you'll look at those 

25 curves there's that that dip. I think the Cincinnati study 

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1 shows that most clearly. So that the infant from 0 to I 

2 years is very — 

3 DR. UPTON: We've got a bunch of hands up here. 

4 DR. BRISKIN: I didn't answer the second part of 

5 your question as to what proportion of drinking water lead 

6 is a total exposure of lead. 

7 DR. MAHAFFEY: What are you asking? 

8 DR. BRISKIN: Well, see we're not doing an 

9 allocation, we're not doing a reference-dose approach, 

10 where you say, — 

11 DR. MAHAFFEY: (Interposing) But you had to 

12 have some competent information to set a standard. 

13 DR. BRISKIN: Right. What we've done is look at 

14 the non-lead sources for different age groups and I think 

15 that, typically, drinking water ends up to be about 20% but 

16 there's a wide band, in percent of total lead intake. I 

17 think it goes below 10% and up as high as 50%. 

18 DR. MAHAFFEY: So my suggestion that you had 2 

19 micrograms per deciliter to play with is right. 

20 DR. CHISOLM: If 10 was your blood lead--

21 DR. MARTINSON: If 10 was your goal. 

2 2 DR. CHISOLM: It's right around that range. 

23 (Talking on top of each other) 

24 DR. BRISKIN: What we're trying to do is to 

25 minimize the number of children papulations that have blood 

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37 

1 leads above the level of concern. We have a technology2 based standard that we can only get an enforcement standard 

3 as low as what was stated and given a choice of two types of 

4 technologies or possible standards, as long as they are 

5 feasible, we would choose the one that would bring more 

6 children below the blood lead level of concern. But, we're 

7 not able to prevent all children from going below a human 

8 blood lead level of concern. 

9 DR. UPTON: There's a number of people who 

10 wanted to make comments, I believe Dr. Larson is first. 

11 DR. LARSON: Yeah, he is. That's perfect 

12 timing. I guess it comes closer to a question of 

13 predicting the average values versus predicting the 

14 percentage of blood lead in extreme cases. It seems to me 

15 the EPA policy is to protect the — minimize the exposure of 

16 the highest levels. That comes down to a question of to 

17 what extent are these distributions of blood lead caused by 

18 drinking water or by air sources, direct or indirect. 

19 Independently because one could simply -- as the 

20 doctor calculated just a few minutes ago and took to the 

21 mean values and multiplied them and compared them to another 

22 mean value. But the real question is, kids who are getting 

23 the high blood lead or high water lead doses. These kids 

24 are getting high lead from direct or indirect air sources. 

25 DR. BRISKIN: Sometimes, sometimes not. That's 

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JO 

1 why we've gone away from doing a simple type calculation and 

2 just take a coefficient and multiply times the water lead 

3 concentration and then put that out as an average water lead 

4 contribution and then put that out as an average non5 drinking water lead contribution. We are concerned about 

6 the details and I hope that by using information on blood 

7 lead distributions and water lead distributions that we can 

8 count them both as explicit information on water lead 

9 distribution, which make it difficult. There's very little 

10 data matching water lead levels and blood lead levels 

11 relative to other things that are around. 

12 So we're doing a lot of modeling in trying to 

13 assess the relative appearance alternatives. 

14 DR. LARSON: When you went to the exposure model 

15 exercises, that was to predict means and then you go back 

16 into the population look at the distributions above that. 

17 Then, as you say, the staff was not able to come up with a 

18 way to segregate, if you will, the water lead versus air 

19 indirect and direct lead contributions to the distribution. 

20 But it seems to me that distribution makes ail the 

21 difference in terms of the standards analysis and the extent 

22 to which in the future more and more is directed toward 

23 looking at that. It makes all the difference in terms o|-

24 integrated policy. 

2 5 DR. BRISKIN: One thing that we have to do, is 

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IQ 

1 to assume that water lead levels are distributed randomly 

2 across the population so that there's this joint 

3 distribution — distribution of blood lead, non-drinking 

4 water exposure and distribution of drinking water exposures 

5 and those are matched up randomly. 

6 So in a portion we have water lead distribution on 

7 each group of kids with different non-drinking water 

8 contributions. That's a big part of the difficulty in 

9 detecting that. 

10 DR. UPTON: DR. RABINOWITZ 

11 DR. RABINOWITZ: Just a few comments, one of which 

12 I'd like to underscore. I think it's an opportunity that 

13 you're aware of here and that is that the relationship 

14 between blood lead and water lead is not a straight Line, of 

15 course. 

16 And that the change in blood lead for a small 

17 increment in water lead is much greater. The payoff in 

18 changing blood leads is greater down at the low end of 

19 water, say, you might say low -- lower than 20 micrograms 

20 per liter, so that, any changes in water lead exposure 'luwn 

21 at that level, paid off more terms of blood lead than 

2 2 changes at the high end. 

23 So if the opportunities to prove blood leads to 

24 the population get a lot larger when you make changes at the 

2 5 lower water end". 

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40 

1 DR. BRISKIN: Yeah, in fact, we see benefits at 

2 both ends. The big slopes at low water lead concentrations 

3 means that there's benefits to be had by a great number of 

4 people across the country. Even though there may be a 

5 lesser slope at high water lead concentrations, because 

6 those water lead concentrations can be very high, we 

7 wouldn't want the drinking water with hundreds of parts of 

8 lead in it, anyhow. 

9 DR. WESOLOWSKI: Something you said here, I have 

10 to be a little skeptical about. When you show the role of 

11 water lead as the total intake at different blood lead 

12 levels in the sketch you made for us. 

13 I got the impression that you're trying to say 

14 that at the high blood lead levels water plays a smaller 

15 percentage role. 

16 DR. BRISKIN: Smaller piece of a bigger pie. So 

17 the absolute value of the contribution, depending on how 

18 big that pie is, may be smaller to and equal to in greater 

19 than absolute value of the contribution. 

20 DR. WESOLOWSKI: I guess I got a little skeptical 

21 about that till I know what these other sources are. in 

22 cases where the absence of lead paint and in the absence of 

23 lead air, all these other things -- and as you have higher 

24 blood leads, not only does the pie get bigger but the 

25 percentage from water also gets bigger. So, I'm just nut 

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1 sure. 

2 DR. BRISKIN: Over time drinking water lead, I 

3 believe, is increasing, depending on whether it stays the 

4 same and so if your, for the moment, leaving paint lead out 

5 of discussion and you're seeing drops in the total blood 

6 lead from drops of lead gases, drops of lead in air. You've 

7 got a shrinking pie. But if the drinking water mass for 

8 lead has remained constant, then your pie is not flawless, 

9 it's shrinking with the non-drinking water. The pieces are 

10 smaller, but the portion taken out by drinking water is 

11 greater than it has been in the past. 

12 DR. WESOLOWSKI: Are you and I together? 

13 DR. BRISKIN: That's the constant in drinking 

14 water. The drinking water pie shrinks and the portions 

15 redistributed themselves somehow. They all have to add up. 

16 (Talking at same time.) 

17 DR. WESOLOWSKI: I have trouble thinking of ail 

18 these things changing over time. I guess even if with a 

19 snapshot picture of it. You made a statement that I've just 

2 0 got to be skeptical about, I guess, and that is how do you 

21 know that at the higher blood leads the water is a smaller 

22 ration than — 

23 DR. BRISKIN: (Interposing) I was saying that --

24 I meant that as an example. 

25 DR. WESOLOWSKI: Okay. So that' may not be true 

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4 2 

1 that U.S. population --

2 DR. CARLSON: A set contribution of say 2 parts 

3 per billion or 2 micrograms per deciliter or whatever 

4 terminology you want to use. 

5 DR. BRISKIN: For constant drinking water 

6 concentration overlayed on distribution of non-drinking 

7 water contribution, but that of course has the right number 

8 of the distribution. 

9 DR. UPTON: Dr. Wesolowski. 

10 DR. WESOLOWSKI: The sources of lead in our 

11 drinking water are — in terms of ground water, come from a 

12 deposition of ambients, particles, and also from crustal 

13 weatherings. You have a feeling for what percentage of the 

14 contribution these two are and how would the lowering of the 

15 National Air Quality Ambience Standard lower the lead levels 

16 in water in time? 

17 DR. BRISKIN: Generally, you find relatively few 

18 water supplies that have lead in their sourcewater. We 

19 estimate that out of about 60,000 water supplies that we 

20 regulate, less than 1000 would have lead levels of less than 

21 5.3. We find that the lead particulates tend to settle out, 

22 so before water suppliers service one, there's an attempt at 

23 conventional treatment which is filtration or some type of 

24 settling. The particulates tend to settle out. 

2 5. I don't have data on, to make any estimates on how 

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1 lowering deposition would lower that incidence of -- as far 

2 as I know --

3 DR. WESOLOWSKI: (Interposing) Well, that's 

4 possible. 

5 DR. BRISKIN: Yeah. 

6 (Reporter - Your voices are getting lower.) 

7 DR. UPTON: Dr. Chisolm. 

8 DR. CHISOLM: If I were to select an age, I 

9 would take three months. Because the water requirement, no 

10 matter whether he's calculated that on the basis of body 

11 weight or calories metabolized, it's really highest from n 

12 to 3 months of age and then it tapers off. 

13 If you're thinking in terms of concentration, it's 

14 probably more the diet than is primarily milk and juice. 

15 DR. BRISKIN: We're trying to identify the most 

16 sensitive people and we have to use the conversion 

17 coefficients that are available to us in the literature as 

18 far as relationships of blood lead and water levels. 

19 DR. SILBERGELD: You shouldn't let — wait, this 

20 is backwards thinking. You shouldn't let what you can find 

21 in the literature to construct your exposure paradox 

22 determine a viable medical judgment as to what's the most 

23 sensitive population. That's just, oh, that unacceptable. 

24 DR. BRISKIN: I wasn't implying it, I was trying 

25 to doing the analysis, and if the data were available for 

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44 

1 say, 6 months olds and you're instructing me that 3 months 

2 olds are a more appropriate amount of data for 3 months 

3 olds, I was trying to figure out how I might do that. 

4 DR. CHISOLM: Well , you certainly can if you get 

5 any one of the major pediatric texts and look at water 

6 requirements according to age and caloric requirements 

7 according to age. Then make your calculations of the 

8 amounts assumed on that basis and then look at the 

9 concentration. 

10 DR. BRISKIN: It's certainly something that we 

11 can look into. 

12 AUDIENCE MEMBER: I apologize for getting here 

13 late, and perhaps missing it, but, you know, Market Research 

14 Corporations of America publishes a lot of information on 

15 food intake at some of these very young age groups. 

16 And one of the things you might think about in 

17 this instance; there are some products marketed that you 

18 really rehydrate the products that you would be using with 

19 home water. 

2 0 So, you could use the kind of approach Dr. 

21 Chisolm suggested, adjust for total salitic requirements 

22 that's given various marketin g practices in different parts 

2 3 of the country. 

24 You might want to assume that virtually all this 

25 fluid could, in fact, come from the home water supply. 

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1 DR. UPTON: Dr. Von Lindern. 

2 DR. VON LINDERN: I wanted to go back to our 

3 charge here for a second and maybe show just how confused I 

4 am. The charge here was whether the Agency has consistency 

5 between what we said yesterday in the 'Drinking Water Talks' 

6 and the standard. 

7 Right now, I understand that in estimating blood 

8 lead levels you're using some sort of disaggregate slope 

9 methodology independent of baseline blood lead levels. 

10 Whereas, yesterday we through a methodology of 

11 integrated intake from a number of sources. In the Office 

12 of Solid Waste thing here, I see that they use some sort of 

13 specific or generic modeling which varies on chronology of 

14 developing standards in a particular application. I'd just 

15 like to get a sense that everyone in this Agency is using 

16 the same baseline blood lead levels in their calculations in 

17 the same dose response methodology and can you tell me if 

18 'Drinking Water' and at least OAQPS are doing that. 

19 DR. BRISKIN: We are working everyday with OAQPS 

20 to use the same blood lead levels of concern, the same 

21 studies, the same analyses of those studies, to the extent 

22 that we are able to. We spent a great deal of effort, trying 

2 3 to coordinate our assumptions and drink water and 

24 non-drinking water exposures. 

25 So as far as blood lead levels are concerned --

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1 and even our approach towards calculating the things, even 

2 though we haven't had an update in a while, we're still 

3 trying to be very consistent with — and from there we felt 

4 drinking water standards and from there solid waste programs 

5 evaluate clean-up alternatives for pharamceuticals. But 

6 we're trying to be very consistent. 

7 DR. UPTON: Dri Carlson. 

8 DR. CARLSON: Yes. Partly in answer to Dr. 

9 Larson's comment. It really becomes almost a matter of 

10 philosophy, in other words, if you try to get the lead level 

11 down low, we're talking about these percentage 

12 contributions. 

13 One of the difficulties that we run into is about 

14 22. And you're saying to yourself, water, I mean I can 

15 argue either way and say, well, don't worry about the 

16 water, because 2 out of 22, you've got to do some more 

17 intervention than that. Or, I can argue the other way, 

18 that, that's a little bit more beyond whatever we did have. 

19 So, I can argue either way, so if it comes down to 

0 the both sides of the problem, depending upon where you are 

21 in this curve. 

2 2 DR. UPTON: I think that in the interest of time 

23 and there are other presentations to be made this morning. 

24 We would thank Dr. Briskin for her presentation, and call on 

2 5 the next speaker. It is my understanding that we are to 

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1 have a presentation from the Office of Solid Waste. Marlene 

2 Berg. 

3 We have a presentation from the office, I guess, 

4 from Bob Estral. Will anyone present this for us or are we 

5 simply read it and comment on it? Shall we take a moment 

6 to read it, those of us who haven't had a chance to do so? 

7 I suggest we take a ten minute break, to read this 

8 and reconvene at 10:15. 

9 (Whereupon a ten minute break 

10 ensued.) 

11 DR. UPTON: We've distributed the discussion 

12 papers from the Office of Solid Waste. I don't know if any 

13 of us saw this paper before today. I saw it for the first. 

14 time this morning. My sense is that it contains relatively 

15 little information, and for that reason, may not testify any 

16 lengthy discussion. 

17 I don't want to foreclose the discussion and I think 

18 there are comments that members of the Study Group or others 

19 would care to offer we should, we should allow them to be 

20 expressed, but there is no one here to answer questions. 

21 DR. WESOLOWSKI: That one of our mandates is to 

2 2 judge whether or not the EPA programs on lead is 

2 3 integrated. The fact that we have this piece of paper and 

24 no representative from that office indicates to me that it's 

25 not integrated. 

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1 (Laughter) 

2 DR. FRANK: We also do all our work with the 

3 Office of Solid Waste people and try again to bring into 

4 play the other scientific information that, in evaluation, 

5 that's the sort we've all been talking about. 

6 Those in regard to air in the water the other day. 

7 I don't know the specific•reasons as to why the 

8 representative -- he was planning to be here and he's not 

9 here — from Office of Solid Waste. But it does not mean, 

10 by any means, that we're not working with them. 

11 I think you'll see from some further discussion 

12 that you'll see from the information that Ronnie Levin will 

13 provide that there is some integration across the program. 

14 DR. UPTON: Well, I think it might be appropriate 

15 in the absence of someone in the Office of Solid Waste to 

16 call on Ronnie Levin and ask her to make her remarks, that 

17 were intended to deal with a broader issue. 

18 DR. WEISS: But before we do that I think the 

19 Committee ought to let the Administrator know that we're 

20 upset by the absence of a representative from OSW. 

21 DR. UPTON: I think that does reflect the feelings 

22 of the committee. Why not ask Ronnie Levin then to make her 

2 3 remarks if you would please. 

24 RONNIE LEVIN: I'd first like to finish up the 

25 last discussion before I change gears and that's about --

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1 DR. UPTON: (Interposing) Want to come up here? 

2 MS. LEVIN: Sure. 

3 DR. UPTON: Ronnie Levin, from ORD. 

4 RONNIE LEVIN: The point that I had wanted to 

5 make — to start out with, is that I would recommend to you 

6 that in addition to having a representative from the Office 

7 of Solid Waste, that you also have somebody from Emergency 

8 Response, because in fact, those two parts of that one 

9 office, in fact, have somewhat different problematic needs, 

10 and since their needs are so very different, you should 

11 really have representatives from both sides of that office. 

12 DR. COGLIANO: I'd like to mention before coming 

13 here I talked with people from the Office of Emergency 

14 Remedial Response on the Super Funded Portable Quantities 

15 Program. And I could tell you about that program, and I 

16 discussed some things we might do with them, so I think I'm 

17 there, partially as a representative of people from that 

18 office. 

19 RONNIE LEVIN: Well, would you want to talk to us 

20 about that? 

21 DR. COGLIANO: I don't really have a prepared 

22 talk on that, I can answer questions about the Portabl " 

2 3 Quantities Program, and what we might be doing with lead in 

24 the future on that. 

25 DR. SILBERGELD: I know that this came up 

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1 peripherally when we were talking about the leaded cancer We 

2 need to talk about also the implications of the leaded 

3 cancer decision. 

4 DR. UPTON: Why don't we have Miss Levin's 

5 presentation and then allow Dr. Cogliano to make his 

6 remarks. 

7 DR. COGLIANO: Thanks — Okay. 

8 RONNIE LEVIN: I've had to do a little mop-up 

9 work and so I'm just going to do some general summaries from 

10 filling in the gaps. Obviously this is a huge area and I'm 

11 not going to hit them all. 

12 Among the elements in EPA that approach to letter, 

13 of course, they criteria document the lead in their review 

14 of that. There's work ongoing in soil lead abatement. 

15 We're tried to super fund money. There are a few specific 

16 projects that are now under way. There are also broader 

17 methodological issues that are being raised by that. 

18 We have recently begun to do some work on lead 

19 based paint abatement. We're looking at health, potential 

20 health standards also technology issues there. This is a 

21 recent development. 

22 Lead in drinking water has turned somewhat about. 

2 3 We're doing again some health and exposure analysis as well 

24 as some technology development work. 

25 What's not listed here are the water quality 

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r» I 

1 standards, which would not be the drinking water standards, 

2 but for the environmental effects being considered. But 

3 that's not right now a regulatory outburst, but that is 

4 another potential area within EPA. 

5 What we've not represented this morning, but is 

6 this huge issue within EPA, are the disposal clean-up 

7 issues. They are broad based in the country and many 

8 issues. 

9 And finally, sort of an overall pulled together 

10 regulatory review and research plan that is currently under 

11 way in the Office of Research and Development. Being 

12 developed, in fact, by like grants and mainly within our 

13 offices to address the -- to pull together, to integrate and 

14 coordinate all the desperate efforts that are going on 

15 within the agency. 

16 DR. COGLIANO: So that's both research and 

17 regulation? 

18 RONNIE LEVIN: That's right. 

19 DR. COGLIANO: Just to be sure it's essentially 

20 trying to put in one place an overview of the different 

21 regulatory activities. And then what comes out of them as 

22 some significant and research needs and then hopefully to 

23 move to the next effort into operation plans. 

24 DR. UPTON: Is it part of the --

25 DR. COGLIANO: (Interposing) That's taking -HI 

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1 the roll of responsibility to integrate all the different 

2 program office activities. Just so everybody understands, 

3 in a sense, that would be us irrigating the powers that we 

4 don't have. 

5 RONNIE LEVIN: Just to step up a little of the 

6 brief summary of the Regulatory Enforcement Agenda of the 

7 Agency. 

8 We tried to define air as a technology transfer 

9 because for many of us it effects regulations that are under 

10 way. The technology transfer component is the key to 

11 whether the program -- whether the regulation is actually 

12 going to work. 

13 Drinking water and clean-up are two areas where 

14 all the past regulatory development in headquarters won't do 

15 anything, if in fact, when it comes to the actual 

16 implementation of it, there is an adequate resource or 

17 technology to support it. This is a huge area --

18 There are also some international efforts 

19 underway. Lead contamination of the environment is a big 

20 problem in industrialized countries and so we're trying to 

21 work with the European community and with Australia and New 

22 Zealand to teach them some of the hard lessons we've learned 

23 and to learn from them some of the lessons tliat they've 

24 learned. 

25 It's also — lead contamination is also a big 

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1 problem in developing countries. So we're trying to work 

2 with developing countries to help them avoid some of the 

3 pitfalls that we've encountered. 

4 We also identifying specific research needs and 

5 trying to establish priorities among the different research 

6 needs. The needs are — and trying to look across our 

7 program and our regulatory needs to decide what are the best 

8 places are to sink our resources. 

9 And finally, we're interested really in crafting 

10 the big picture of strategy and in crafting a big picture of 

11 strategy, I just wanted to finish up by raising some of tin; 

12 big questions that we have. There are open questions. 

13 Apparently both the Office of Policy Planning and Department 

14 of Research and Development have begun to look at the big 

15 picture of lead. And that's led to raise some questions 

16 about how we think about pollutants in the U.S.. 

17 It also has shifted our gears from identifying 

18 specific element to specific health effects to specific 

19 population, and forced us to try and integrate some of what 

20 we're thinking about. 

21 First of all, there are serious new health 

22 effects that are making us re-think some of what we're 

23 doing. Feelings about issues, that you've already begun to 

24 speak about here. The nature of bone storage. How inert a 

2 5 compartment it is. It's a point both for its health 

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1 implications and for the long term exposure implications. 

2 Old age may be another time period in human 

3 development where there are specific and great health risks. 

4 And that raises new questions about health effects that we 

5 have not in past investigated at all. 

6 In addition to the specific health effects, 

7 there's been health issues that we're beginning to think 

8 about. One of the questions that has come up a few times 

9 about reversibility. 

10 Reversibility, reserve capacity is similar to 

11 capacity. Obviously these all feed into questions and 

12 thresholds. Questions about what the body can absorb. And 

13 we're not sure what to do with those. There's a finite 

14 similar to capacity or reserve capacity in the body, but 

15 we're not sure exactly how to address those issues. 

16 Another health issue of concern is that the 

17 baseline of concern has moved. But it's not only for blood 

18 lead levels, but some of the measures that we've been using. 

19 For instance, blood pressure, the blood pressure levels of 

20 concern have changed in fact, and in evaluating sources and 

21 needs and therefore regulatory development, this has raised 

22 some health issues for ns. 

23 As we look at measured effects moving towards 

24 lower and lower levels, we're meeting a crossing of 

25 threshold. For adverse effective rays that none of us 

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1 though about five years ago, all of a sudden begins to take 

2 on meaning. Now what is adverse effect? This is a context 

3 that we didn't have, but as detection limits have come down, 

4 it's like we're all of a sudden having new problems that are 

5 big health issues. And we're not sure exactly what we are ' 

6 going to do with these. 

7 The carcinogenicity issue which you've all been 

8 dealing with here for the past month or so. It is not a 

9 negligible risk, not a huge risk, but there are open 

10 questions about the cancer causing potential mechanism in 

11 water lead. That's another thing that we need to keep in 

12 the pot for consideration is the health issue. 

13 Following that, there are some big public policy 

14 issues that we're struggling with and you're struggling 

15 with. We have to address lead as a multi media pollutant, 

16 and we've all had the leisure, or perhaps the restriction of 

17 dealing with lead on medium by medium, air verses water, 

18 verses solid waste. 

19 But in fact, in addressing a multi media 

20 pollutant you can't departmentalize and expect that you in 

21 fact accurately represent exposure or the problem. And 

2 that's a big problem for us. We need to move away, I think, 

2 3 from making judgments about which source is more important, 

24 which health effect is most important, which population is 

25 the sensitive population for a specific thing., 

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1 In fact there are broad issues that we need to 

2 integrate in some way into different programs, but this will 

3 come out in different ways, but these are big, open 

4 questions that we have. 

5 The two approaches to the public health 

6 approaches, one of, in reducing population explosions, one 

7 is shifting the whole distribution, the other of truncating 

8 the tail raises questions for our different programs. 

9 Also how to compare relatively high risk specific 

10 small populations against low level exposure in huge 

11 populations. We've all been struggling with these 

12 distribution issues and we're really not sure what to do in 

13 these cases. 

14 This has also become more important as congress, 

15 in fact, is moving to give EPA, give us a nod for assuming a 

16 more integrated role, integrate its role in lead 

17 contamination of the environment. We're talking about lead 

18 paint which is normally seen as a hot issue. Lead 

19 contamination control actually gave EPA authority over water 

20 coolers, which is not anything that we had done before. We 

21 have also identified the school drinking water, which is not 

22 a community that we have traditionally regulated. And so, 

23 this is just added to the difficulties of really developing 

24 an integrated approach to all these issues, and SL? I don't 

25 have any answers to date, but they are new, big questions 

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1 that EPA is beginning to struggle with. 

2 Thank you. 

3 DR. UPTON: Thank you Ms. Levin. Any comments? 

4 Dr. Silbergeld. 

5 DR. SILBERGELD: Maybe Lester could also speak 

6 with us too. Is there any, as part of this, is there any 

7 effort going on to try and develop a kind of integrated 

8 picture, related to the source term? 

9 That is, the kind of work — I'm thinking ot two 

10 examples. One is the kind of work that Gary had recently 

11 done, looking at the total input picture of lead. Is there 

12 any attempt to do that for the United States, as well as 

13 projections of changes? 

14 And then the other, which is very interesting. I 

15 heard at the National Academy of Sciences -- National 

16 Academy of Engineering meeting by an economist at Carnegie 

17 Mellon, whose name slips my mind right now, where he's done 

18 with what he calls metal metabolism studies, which is 

19 somewhat akin, in which he looks at the flow. 

20 He's done this for cadmium and for zinc. And he's 

21 started on lead. He sent me some of the stuff. He looks at 

22 the flow from extraction, through systems of production, 

23 appearance in consumer products. He hasn't really gotten to 

24 the waste side, which is, of course, our mystery guest. I 

25 wondered whether -you're approaching it -- You're doing, r 

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1 think an exemplary job of integrating from the receptor 

2 side, for the first time. Of looking at populations, and 

3 what's going on there, and you're stepping one step back to 

4 the media of proximate contact water, etc. 

5 But I'm wondering about the source terms, and to 

6 what extent you're able to do that and whether you are 

7 starting to do that. 

8 DR. COGLIANO: Well, I think, Ellen, that 

9 different program offices are carrying out their 

10 evaluation. How, generally speaking, it looked at, one <.vr 

11 another segment of that source receptor relationship or 

12 whatever. 

13 DR. SILBERGELD: Yeah, but that, that has been very 

14 misleading and I think get us into these debates as to which 

15 is more or less important. I'm wondering whether there's 

16 been an overall attempt. 

17 DR. COGLIANO: I don't think there's been an 

18 overall attempt in that sense for lead. There had earlier 

19 been things, at times, some number of years ago, some 

20 projects that did a little bit, say Kathy Ember or somebody 

21 in that area, come close22 I think that one of the kinds of items that we 

23 identified in the discussion at meetings that we had. We 

24 had a Deputy Administrator and you, and others from the 

25 different program offices to be looked at. 

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1 So it' s identified as an issue or a point to be 

2 addressed. I think to date there has not been a single 

3 coherent project effort or something identified where you 

4 would pull all of those things together. 

5 DR. WEISS: You know, I'd like to suggest that we 

6 scrutinize the nature of this to our surroundings. A 

7 library in scenario given different circumstances 

8 RONNIE LEVIN: (Interposing) The word library 

9 wasn't in it when you mentioned it to me, it was just a 

10 number of — 

11 DR. COGLIANO: -- I just expanded it. A number of 

12 different scenarios, making different assumptions about the 

13 contribution of different sources, and the consequences of 

14 different kinds of abatement. 

15 You've seen perhaps one or two endpoints. A 

16 possible endpoint would be the distribution of scores on 

17 psychological tests. And then you could determine how 

18 different strategies, or change would impact that 

19 distribution, using that distribution to develop a 

0 quantitative measure of risk based on the population 

21 distribution of scores. 

22 And then you would have some means o| 

2 3 communicating to people like me, what the ultimate result 

24 would be of minor or major changes in all of the different 

25 media. 

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1 I don't think you can construct a formula right 

2 now for demonstrating the impact of the change of one media 

3 on the total constellation of endpoint. 

4 I think what you need now is a more 

5 impressionistic communication of these changes. I think 

6 that would be a very useful way for integrating all of the 

7 different program offices and their total health 

8 implications. 

9 RONNIE LEVIN: I think that a really intriguing 

10 idea. Thank you. 

11 DR. HAMMOND: In the past, EPA has made 

12 decisions, recommendations concerning the air lead. Those 

13 decisions, as I recall, were never followed by a systematic 

14 quota to evaluate the consequences of the decision. 

15 Now, I think you kind of lucked out, so far as NU2 

16 is concerned. I don't think, in fact, you were responsible 

17 for NH2 as a source of valuable information. And so what 

18 I'm asking is, now in 1989 is the EPA going to do something 

19 about that failing of tests for whatever reason? 

20 You're going to have an NH3, I understand that. 

21 But do you have a plan for using NH3 for getting 

22 supplemental information that you need that is not built 

2 3 into an NH3, in order to evaluate the impact of consequences 

24 of your decisions in 1989? 

25 DR. "FRANK:- Yeah. -- First of all, I think, 

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1 perhaps you overstated the case, as far as not having some 

2 mechanism in place to evaluate it with. 

3 What happened, I direct your attention, in your 

4 green book to page 2-3, in which I very nicely characterized 

5 for you. Okay? We have what has gone on, in fact, in regard 

6 to the impact of air movement -- abatement, if you will. 

7 What's happened as far as staffing with reduction in lead 

8 and gasoline air standard. 

9 If you look on that page, it's page 2-1, and then 

10 the figure down below, 2-2. I think you will find there 

11 very excellently depicted the consequence of our regulatory 

12 action. In fact it has spelled out quite a success story. 

13 Probably one that the Agency needs to process more and let 

14 people know up here. By golly, when you undertake some of 

15 these massive efforts that we've all been involved in for 10 

16 years, or more, advise there are some very real 

17 environmental benefits to be gained. This tells the story of 

18 that. 

19 DR. GRANT: I have a question. The question is 

20 really as to whether that was defined as the result of 

21 action through the time of that air lead standard. 

2 2 DR. COGLIANO: We have a. regular program. A 

23 radiant by which the Air Office is looking at, what is 

24 going on in the way of emissions and also air 

25 concentration; -in relation to all the - criteria air 

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1 pollutants and a number of others as well. 

2 So that you have in places, and have had for a 

3 very long time, at least one of the kinds of mechanisms that 

4 is looking at the environmental level related to air, and 

5 that's what is depicted here. That still exists and will 

6 continue. 

7 Let's go to your next question, and that is the N. 

8 Haines business which did provide to us yet another very 

9 useful mechanism or whatever by which to have a look at it 

10 that is, if, had blood leads -- and therefore provided us 

11 with very high curves or whatever, by which we could see. 

12 After 1978, especially, a very dramatic dropoff 

13 with major reduction in lead gas took place and blood leads 

14 came on down so, I haven't seen them in here. So anyway, N. 

15 Haines 3 does contain provisions for blood leads and 

16 essentially to provide another snapshot of what's happening 

17 in the late 80's or early 90's. Now, is there a very well 

18 coordinated, integrated, whatever connection into there, and 

19 do we have, EPA, a super opportunity to perhaps get other 

20 additional things out of N. Haines? 

21 The answer to that is a mixed yes and no. We've 

22 had ability to give some input to the recommendation, but 

23 were not in a position to strongly determine what is going 

24 to go on with the N. Haines. Katie, I'd like to know if you 

25 want to add something on the N. Haines?-

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1 DR. MAHAFFEY: There is a lot I could add to it, 

2 most of which it is probably better not to. In terms ul--

3 I am looking at this from several perspectives because I am 

4 on a National Academy of Sciences committee about monitoring 

5 for normal contaminants in both environmental and tissue 

6 samples. There is a major lack of information in this area. 

7 One of the things I am really quite concerned about is 

8 sampling of chemical and bacterial quality of water at the 

9 tap. It is important to know what is going on at the 

10 reservoirs, but let's face it, the water that we drink 

11 typically is coming from the tap. 

12 We have had many many calls from people who are 

13 concerned about water, who are concerned about bottled water 

14 and one of the things we repeatedly go back to nicrobial 

15 safety. If you have filters on taps because people lack 

16 confidence about it, the chemical quality of the water just 

17 makes for another type of problem. 

18 I think EPA has certainly not publicized, if they 

19 have the information, on the extent of sampling of water at 

20 the tap and the water quality once it has gone through the 

21 entire distribution system. 

22 At one point there was some discussion about 

23 adding water samples to M. Haines for the people who wei.o iu 

24 N. Haines 3. I don't know whether that part bf the ending 

25 surveys "stayed in it, because again- we- have had rather 

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1 limited ability to find out what is happening. 

2 I don't know which part of scientific advisory 

3 boards would deal with this, but I think that EPA should be 

4 in a much stronger position to make recommendations for this 

5 national survey. Granted there are limitations on the 

6 amount of lead available and certainly you don't want to be 

7 using biological samples that are difficult to obtain and 

8 valuable for many reasons in ways that wouldn't produce the 

9 best qualify of scientific information. 

10 But the other side of it is I think the 

11 reservations of EPA and some others should have had in this 

12 were not given very good treatment by a number of different 

13 sources. 

14 I think this is something the science advisory 

15 board overall should really take a look into. 

16 DR. MUSHAK: Could I just follow up on your 

17 response to my perhaps overstated concerns. 

18 DR. McCLELLAN: Okay, Paul. 

19 DR. MUSHAK: As an example of why I was concerned 

20 is the fact that one important piece of information is 

21 missing that you could have had, I believe, had you had the 

22 money. That is the consequences of the phasedown of lead i.n 

23 gasoline on the concentration of lead in soil and dust. it 

24 is not there. 

25 Now, I don't know if that. is. expected. V would 

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1 say it was a fairly obvious measurement needed in the 

2 evaluation of the phasedown. I guess that if it is of any 

3 help whatever, that this committee and other committees 

4 could recommend whatever they feel or they and you feel are 

5 needed as programmatic objectives for evaluating the 

6 consequences of what you do vis a vis lead or anything else 

7 for that matter. 

8 DR. HAMMOND: I think that generically that is 

9 likely to be a very helpful thing because of the 

10 recommendations of SAD or whatever, that the agency 

11 undertake to evaluate the consequences of facts as it were. 

12 There are some various efforts and various bits and pieces 

13 whatever where that is attempted. 

14 I think in the case of lead in soil specifically, 

15 the last go-around, as far as N. Haines, at that time I 

16 think it wasn't as it was planned in the early '70's and so 

17 on we weren't even at a point where we had a definite 

18 program to remove lead from gasoline shall we say. That 

19 came about by the time that earlier ending was planned on 

20 being conducted. It is parallel independent of that. 

21 It was too late in a sense there right off. I. 

22 think this go around -- and again, Katie, you can correct me 

23 — I don't know that the available overall monies or pots of 

24 monies for it would allow in the N. Haines or Ln the 

25 structure, of all.of.it to do much of a .national survey on 

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1 what is happening to the soil2 Anyway, we probably will get or are getting other 

3 information which is through other research programs that 

4 will provide some indications or whatever. I will just make 

5 note of one thing. Some of our water research programs are 

6 finding, and they are monitoring or looking at various lakes 

7 and rivers, streams, whatever, sediments in them, that i.n 

8 fact over the past number of years there has been a rather 

9 dramatic decrease or decline in the lead levels being found 

10 in those sediments and so on and is thought mainly to be due 

11 to the removal of leaded gasoline and secondary deposition 

12 or whatever. 

13 We are going to have to be looking at exactly 

14 those patterns and trying to relate them over time to the 

15 sense that we can in fact know what is going on. There is 

16 likely to be some sort of a time lag we should expect 

17 between leaded gasoline phasedown. There is a very 

18 immediate connection with decreases in the air levels that 

19 are we 11-demons trated. But then perhaps as a lag time for 

20 what is happening in decreases in sediment of waters and 

21 streams. 

22 Anyway, I think -- going back to some of the 

23 earlier discussion -- I don't think there are any lead 

24 measurements as far as in drinking water as part of N. 

25 Haines 3. I don't think that that is part of it. 

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1 You mentioned something earlier and that was 

2 money. Believe it, for real, in terms of what, would be 

3 ideal to be done in relationship to a lot of these different 

4 kinds of evaluations and analyses, that does come into play 

5 and it is a very, very big substantial factor in terms of 

6 what indeed the agency can attempt to undertake. 

7 In these days of the huge budget deficits and so 

8 on in the last number of years, you have to deal with that. 

9 It becomes a lot harder and harder in establishing 

10 priorities and so on to do it. 

11 DR. UPTON: There was a group who wanted to 

12 comment — Dr. Mushak, Rabinowitz and Wesolowski. 

13 DR. MUSHAK: Two questions. The first has to do 

14 with this business of what constitutes an adverse health 

15 effect. Can we expect that the agency would try to involve 

16 some reasonable guidelines for this problem and 

17 DR. UPTON: (Interposing) And what constitutes an 

18 adverse health hazard. 

19 DR. MUSHAK: Wrestling with the problem of 

20 evolving guidelines for tackling this business of what 

21 really is an adverse effect and kind of in a generic way, 

22 using guidelines that can be applicable. 

2 3 From the perspective of someone who works with a 

24 lot of metals with EPA and other agencies, it is amazing how 

25 lead is really at the cutting edge. You are looking at a 

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1 lot of subtle effects. 

2 If you look at -- it is almost like the late 

3 snapshot of the mercury for example. That is now starting 

4 to look like lead has some effects, but it hasn't gotten 

5 there. 

6 Now part B of that question is failing EPA being 

7 able to do this, is there a default position which is simply 

8 you go to the lowest observable level. 

9 There is a second question. 

10 DR. FRANK: Maybe I better watch what I say at 

11 first. 

12 First of all, obviously the issue of adverse 

13 health effects and how to define them is one of long14 standing concern and so forth and certainly in terms of our 

15 interactions with CASAC, for example, and the air standards, 

16 it is a continuous thing. The Clean Air Act obviously puts 

17 that right out front and we have to come to grips with it. 

18 On one hand, as an example, what Mort described 

19 yesterday, the fact that working with the committee there 

20 have been certain things that have evolved at least to some 

21 extent in a generic sense, we have arrived at certain agreed 

22 on conclusions that there is a more than ten percent 

23 decrement in airway function or whatever, at least for 

24 asthmatics as likely having an adverse effect and can be 

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1 pollutants -- ozone or N02 or sulfur dioxide or whatever. 

2 There has been an evolution. As far as formal 

3 mechanisms, there does exist a work group within the agency 

4 that is taking a look at whether one can develop some 

5 generic kinds of guidelines in terms of approaches to define 

6 adverse effect. That is in part in response to requests 

7 from our previous administrator last year. It would be 

8 helpful to have some additional input along that line. 

9 One thing I think all of us need to keep in mind, 

10 part of our experience I think in the last ten years in 

11 dealing with certainly some of the different air pollutants, 

12 some of the metal and so forth, is maybe we are going to 

13 find ourselves getting into a bit of difficulty in 

14 developing very rigid guidelines. This is because, 

15 depending on some different circumstances, certain changes 

16 that in and of themselves alone may not constitute an 

17 adverse effect, but if they occur in conjunction with other 

18 ones or a constellation of other facts --

19 DR. HAMMOND: You are preaching to the consumer20 DR. FRANK: Yes, to you, Paul. It is useful for 

21 others, a constellation of effect becomes very important. I 

22 think we all need to be very careful as we walk through thi.s 

23 sort of process, to allow, yes, there are certain gen.; r !•• 

24 things, but at the same time allow the flexibility and 

25 operate in connection with that. 

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1 DR- MUSHAK: The question is, I think the agency 

2 needs to look more at a societal definition of an adverse 

3 effect. That we touched on it a little in the ATS report, 

4 that there is, if you will, a national level or 

5 international level cost for effects which an individual is 

6 may be minor. That is, it is one thing to say that Joe Doe 

7 from Indianapolis is a little dumber from that shift at the 

8 highest, not necessarily the retardation. 

9 It is something else to say that the U.S. 

10 collectively is a lot dumber because of ten million little 

11 dumber Joe Does spread all over the country. 

12 So the concept of a macro scale of adverse effect 

13 rather than the conventional clinical approach of a patient 

14 sitting on a chair. 

15 DR. FRANK: Yes, we do that, or take that into 

16 account in some very many ways already, in a number of 

17 different programs. It is certainly reflected in a kind of 

18 approach used in the air office in addressing the standards, 

19 how many people are effected, what the magnitude of the 

20 effect is. 

21 DR. MUSHAK: Yes, but enumerating subjects Is not 

22 the same as saying X-people have a public have a couple --. 

2 3 DR. FRANK: We understand that it goes beyond 

24 just that. 

25 DR. WESOLOWSKI: I would just comment, the 

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1 mortality, we have a base decision of where you may have an 

2 extremely low individual risk certainly in one person, when 

3 you look at it across the wide population you have a large 

4 population, a more significant population at risk. We do 

5 consider those factors. 

6 DR. UPTON: Ms. Levine. 

7 MS. LEVINE: Well, I think that this whole issue 

8 is very new to us and it has lots of forms of the question. 

9 One we keep coming up to which is what happens to the 

10 distribution of people in various classes. 

11 Another thing is what is the magnitude of effect 

12 within specific classes, and then the form of this question 

13 recurs. One thing in several of the cost benefit analysis 

14 that we have looked it is the magnitude of the I.Q. effect. 

15 But the leveling that takes place there is that 

16 we look at total I.Q. points and it is hard to tell whether 

17 it is a million children with one I.Q. point, or 100,000 

18 children ten I.Q. points. That is a very big difference in 

19 terms of what you think the impact is. 

20 In addition, some of the exposures as we look 

21 across the country, with gasoline there was a relatively 

22 constant coefficient by age, sex anrl race across the country 

23 for the impact of lead in gasoline. For drinking water, as 

24 far as we can tell, it is a very different distribution and 

25 much closer to being bimodal. For lead paint there.may be 

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1 almost a dichotomous variable, that we have people with very 

2 large exposures and we have people with no exposures. 

3 So when you talk about the result of regulatory 

4 efforts, it really depends upon what the specific exposure 

5 is that you are looking at because the distribution of that 

6 exposure takes a different form, it is not the same. 

7 How do we portray the results of a specific act 

8 or this library of scenarios really depends on a whole host 

9 of different ways of asking this question. I think it is 

10 incredibly interesting. It is very new. There are very few 

11 methods that exist, but we are really interested in that 

12 question. We are just beginning to do some work on it. 

13 DR. MUSHAK: A central question, and I am getting 

14 back --

15 MR. JORDAN: I have set across this table since 

16 the early 1980's I have looked at a lot of smart scientists 

17 and debated the same issue you are raising back and forth. 

18 I find that while there have been attempts to do 

19 it, no generic rule has ever been written out that said this 

20 is adverse, and this isn't adverse. Except for a few 

21 effects, it's adverse. Cough may be not adverse. 

22 It is a very, very tough issue and it is 

2 3 addressed each time we review the standards and maybe not in 

24 some well-defined way of doing it. The thing I point is we 

25 do have ongoing- within the agency now a pretty large task 

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1 force where we are trying to focus in at the direction of 

2 the administrator, this task force would set up to try and 

3 get some better definition of what an adverse effect is. 

4 Having listened to some of the smartest 

5 scientists in the world debate this, I really don't know how 

6 enthused I am or what might be the outcome of it. 

7 DR. UPTON: There is a workshop planned dealing 

8 with this broad question. I think Dr. Rabinowitz had his 

9 hand up. Dr. Frank? 

10 DR. FRANK: No, I don't think so, but since you 

11 asked. 

12 (Laughter.) 

13 DR. FRANK: Define work at our neighbors at the 

14 U.S. Geological Survey in their water resources branch and 

15 looking at trends and surface waters. 

16 In response to the question, generic adverse 

17 health effects, I am not included as one of the smart 

18 scientist, but I am going to say my own point of view about 

19 that is that it is very difficult indeed to make generic 

20 criteria because you have to treat each pollutant 

21 independently. 

22 For example, a specified reduction in some 

2 3 spirometric function like a forced biocapacity of ten 

24 percent, unless you know the mechanism of the effect, it is 

25 very difficult to judge its adversity. -A - ten percent 

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1 reduction owing to ozone may be associated with inflammation 

2 the same magnitude of change associated with S02 which is 

3 certainly not associated with inflammation. 

4 So we really have to deal with at least in the 

5 small class of pollutants that I am familiar with — yes, 

6 just to add my comment. A headache in a context of lead 

7 exposure as a symptom has a very different meaning, 

8 obviously and possible encephalopathy and a life9 threatening situation is different than a headache in 

10 connection with inhalation of some other gaseous compound or 

11 whatever. 

12 Again, somebody said is a headache an adverse 

13 effect. You can't answer that question if somebody has a 

14 headache alone. You have got to look at the whole picture. 

15 DR. WESOLOWSKI: The soil problem I would like to 

16 comment on because Bruce expressed frustration working with 

17 scientists. 

18 MR. JORDAN: I didn't mean frustration. 

19 DR. WESOLOWSKI: I can understand that completely 

2 0 because as far as I am concerned from the public health 

21 point of view, adverse health effects have to be defined by 

22 both scientists, then as a public health policy decision, 

2 3 and then as a societal decision. So any workshop where yuu 

24 only have scientists involved has limitations in defining 

25 adverse effects. 

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1 But what I wanted to talk about was Dr. Hammond's 

2 suggestion for a perspective soil survey. I like that idea 

3 because it is always a useful scientific exercise, but it is 

4 expensive and I think that it might have difficulty in 

5 testing the hypothesis as to whether EPA's control strategy 

6 is working. This is because the change in the air quality 

7 standard as proposed yesterday is fairly minimal and because 

8 most of the phase-out of leaded gasoline is so great that 

9 doing a soil survey can test that. It would be difficult. 

10 Instead I think such a soil survey would be of 

11 value in determining the half-life of lead in soils. But 

12 then to test that hypothesis, one would have to measure more 

13 than just the lead in soil, but would have to measure 

14 permeability, rate of soil, different minerals and so on. 

15 So scientifically the thing has merits but it is a more 

16 expensive study and one which might not assist in making 

17 judgment as to whether there are definite standards. 

18 DR. MUSHAK: I think soil becomes all the more 

19 important as you consider the whole sewage sludge bucket. 

20 Nobody knows what to do with that stuff. 

21 DR. FRANK: it has become quite a large issue for 

2 2 the agency to deal with on account of the number things, 

23 including incineration of sludge or municipal waste. 

24 .MS . LEVIN: Sludge is potentially the one source 

25 that is projected as a source of environmental exposure 

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1 projected to increase. That has obviously lots of long term 

2 indications. On the other hand, we have a problem with the 

3 fact that it has to go somewhere, all this waste. But that 

4 is one source of environmental exposure from lead that is 

5 projected to increase. 

6 The other thing is that we have a series of 

7 modeling efforts underway now primarily in our Athens, 

0 Georgia laboratory, a model called MINTAC which is looking 

9 at soil permeability, insulation rates, deviation, and so 

10 forth. So some of that is underway. 

11 DR. UPTON: Two more comments. Dr. Mahaffey and 

12 Dr. Silbergeld. 

13 DR. MAHAFFEY: One of the things that concerns me 

14 greatly seems to be the absence of data on lead in water. 

15 And as Mike has pointed out, the USGS can measure lead in 

16 water. I know from hearing the presentations at the 

17 National Academy, that we know a lot about contaminants iu 

18 mussels and shellfish. 

19 I have asked several times about do we really 

20 know how much lead is in the water, in the water coolers and 

21 who consumes this water, and how much is consumed. 

22 I can understand a lot of changing definitions on 

23 health effects, but it would seem a fairly reasonable 

24 straight-forward question to ask how much lead is in water, 

2 5 where is it, and can't, this be measured at the tap. 

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1 MS. BRISKIN: There are a couple of data bases 

2 that are around on lead in drinking water at the tap. They 

3 weren't necessarily designed to look at national 

4 distributions, but they do give us some idea of what lead 

5 levels are at the tap. 

6 One that was cited in the benefit study for lead 

7 in drinking water is a study that was written up by Paterson 

8 and it looked at water samples that were taken in 

9 conjunction with people who called the Culligan Water 

10 Softening Company because they were thinking about getting 

11 their water softened. 

12 That gave us our first reasonable broad based, 

13 although people debate whether it is nationally a 

14 representative picture of the distribution of water lead 

15 levels in the U.S. That is where we came up with the 

16 estimate that we thought as many as twenty million people 

17 got water with more than 20 parts per billion. Those were 

18 tap samples and they weren't taken that we are now 

19 recommending samples be taken. They were partially flushed 

2 0 and they were taken at random times during the day, but: they 

21 were taken consistently within that data base. 

22 Second, we have data now supplied to us by i h" 

2 3 American Waterworks Service Company which is the largest set 

24 of information we received in anticipation of our proposed 

25 rulemaking and that is a' data base of about fifteen hundred 

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1 data points from the ninety or so water systems that that 

2 company manages. These are consistently taken morning first 

3 froth -- that is samples that have stood in the pipes 

4 between eight and eighteen hours -- one liter samples with 

5 available information on pipe type, solder age, corrosivity 

6 characteristics at the tap. That is the data base we are 

7 trying use to determine possible lead standards. We are 

8 able to stratify that and look at the change in distribution 

9 of water lead levels with change for acidity 

10 characteristics. 

11 Again, it is not necessarily a nationally 

12 representive picture because those companies tend to be in 

13 the northeast. They don't represent the whole country. 

14 So there are data bases that are out there to 

15 give us some idea of water lead levels. We find that 

16 whenever there is somebody who calls the Office of Drinking 

17 Water and say we have sampled in our town or in our school, 

18 the numbers we get tend to be on the order of 15-25 percent 

19 of the samples above twenty. That tends to be a fairly 

20 stable estimate. 

21 DR. MAHAFFEY: One of the reasons we are sort of 

22 harping on this point is that metals continue and wil I 

2 3 continue to be an enormous problem in this country. 

24 Obviously they are not going to go away. There were some 

25 - numbers cited in one of these NAS workshops about -- and T 

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1 hate to quote it because I am not sure of the bounds of this 

2 definition -- but if you look at something like the top ten 

3 chemicals related, half of them were metals. 

4 Now, I wouldn't want to be quoted on that because 

5 I am not sure it is quite accurate. Metals are an enormous 

6 problem for which there is virtually no remaining margin of 

7 safety in many cases. Certainly in most you are not 

8 different by a matter of a factor of ten. It would behoove 

9 EPA to be planning a survey of tap water for metals, 

10 including Ph for acidity. 

11 We have looked at arsenic in water. We are 

12 looking at lead in water. Certainly other metals rapidly 

13 come to mind. 

14 MS. BRISKIN: It is certainly something we are 

15 considering and have considered in the past and continue to 

16 think about — the balancing of whether we have the funding 

17 for doing something like that together with our regulatory 

18 schedule. By law we are required to come out with final 

19 standards on most metals by June of this year. We are not 

20 going to make that, but there is a lot of interest in the 

21 Drinking Water Program. Because we have a standard which is 

22 a technology based standard, get as close to the goal as 

2 3 feasible, some might argue that the distribution infonnation 

24 is perhaps less important than getting information and 

25 improving the treatment techniques to bring those metal 

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1 levels down as close as you can to the health base goals. 

2 Those are the kinds of considerations the agency 

3 has been thinking of. 

4 DR. UPTON: Thanks, Jean. One final comment. We 

5 are running short of time. 

6 DR. SILBERGELD: I would like to back-up maybe 

7 and give you some more fundamental thoughts perhaps in the 

8 specific areas of issues you brought to us. 

9 What Katie says I think reinforces their 

10 importance because they have implications beyond lead. The 

11 agency is certainly to be commended for what you have done 

12 with lead over the 15-16 years. I have certainly been 

13 involved in it. You moved dramatically to a multi-media 

14 appreciation, to a health-based goal. I think without doubt 

15 the actions of this agency have interacted with basic and 

16 medical research in an extraordinarily productive way. 

17 The lead problem consists of .two major 

18 components: One is the past uses of lead, and the other is 

19 the present uses of lead. Unfortunately in the absence of 

20 the Office of Solid Waste, we really can't come to grips 

21 with what is going on primarily in the area of remediation 

22 and dealing with the past residues in the environment, many 

23 of which accumulate in the solid phase. 

24 I just hope that in the scientific and exposure 

5 analyses, you will make known the knowledge that you. have, 

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1 NORD, and in the specific programs, you will make it clear 

2 to the Office of Solid Waste that they need to expand their 

3 concerns beyond the leechability of lead from the solid 

4 phase into hypothetical drinking water sources. That they 

5 adopt a much more integrated approach to the way in which 

6 they gain control of that problem. 

7 But the other point I think is exemplified if you 

8 turn to page 23 in the green book. There is something that. 

9 is very, very interesting here on this table. If you look 

10 at the column for 1987, in addition to underlying our need 

11 to congratulate the agency on the overall impact that its 

12 actions have taken to reduce by over thirtyfold the inputs 

13 into air. What is emerging here is that the solid waste 

14 fraction is now becoming one of the largest single 

15 contributory sources to lead metabolism in the country. 

16 If you add in water and land disposal, I think 

17 that fraction would only increase, very likely. It is quite 

18 interesting with just looking at air, it is so large at this 

19 point. But I am concerned that the focus of attention wiIJ 

20 be just on the first level message of those figures. That 

21 is we have got to get control of solid waste, we have io 

22 figure what to do about sewage sludge, we have to deal w.fi h 

23 incineration, etc. 

24 Because what this is really telling us is that 

25 this is one end point in a metabolic halfway, if you will, 

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1 that lead is ending up in a waste phase which then creates 

2 enormous problems of management. We haven't heard from the 

3 Office of Toxic Substances which is your part of the agency 

4 that can deal with this. Why is so much lead ending up in 

5 this phase and what points of research in terms of analyzing 

6 why this should be so, and then policy decisions which are 

7 amenable and feasible to change this growing fraction of the 

8 contribution of overall lead inputs are available to you. 

9 DR. UPTON: We have scheduled a presentation at 

10 this time from Mr. Robert Fensterheim. Would you take the 

11 floor? 

12 MR. FENSTERHEIM: This is a rather brief 

13 presentation which merely takes us back to the discussion 

14 which you were engaged in before with Jean Briskin. 

15 Let me just say I appreciate this opportunity to 

16 address this committee on behalf of a state that is far 

17 away, California, and representing the Association of 

18 California Water Agencies, which is a water trade 

19 association that is very interested in altering the water 

20 standards, with particular attention to lead. 

21 Just so you know a little about ACWA. It 

22 represents about 360 public water agencies which provide 

23 approximately 90 percent of the water that is delivered to 

24 California. Most of ACWA members are small to midsize, 

25 although ACWA also does represent the largest utility in the 

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1 country and others that fall in that sector. 

2 We understand that part of the mission of this 

3 committee is to examine whether the scientific information 

4 on lead is being applied in a standard and consistent manner 

5 with the agency programs. I guess we are particularly 

6 concerned that it's not, particularly as it pertains to the 

7 Drinking Water Standard. 

8 The focus of the discussion this morning was on 

9 five parts per billion, ten parts per billion, twenty parts 

10 per billion, and various numbers. You were all discussing 

11 what the risks were associated with those numbers. 

12 In our view, what you really need to be 

13 considering is not the MCL standard when you look at the 

14 consistency issue, but the MCLG which is really the goal 

15 issue which is the standard on which health is based. The 

16 MCL is supposed to be as close to the health based goal as 

17 is feasible, but it is not a health based standard. 

18 It is ACWA's view that zero should not be the 

19 health based standard on which EPA develops its regulation. 

20 It should not be the goal if the available health effects 

21 information does not support a zero goal for drinking water, 

22 and this is not the approach the agency has been taking "i23 this committee has been taking with respect to its 

24 evaluation of air. 

25 As I said earlier, according to. the .Safe . Drinking 

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1 Water Act, the national contaminant level goal is to be 

2 established on a level which no known anticipated adverse 

3 effects occur on the health of a person which allows for an 

4 adequate margin of safety. We believe zero exceeds that 

5 mandate. 

6 In fact, we rather share the view of the SAB 

7 Environmental Health Committee, which then reports to the 

8 EPA administrator, made that point back in October of 1900 

9 which took issue with the MCLG that zero was being too 

10 conservative. 

11 EPA has traditionally reserved the zero MCLG 

12 value for percentages. While we don't have full agreement 

13 with that approach, for carcinogens we believe that EPA 

14 should in fact be able to establish a risk base level that 

15 is ten to the minus six, ten to the minus five. 1 am not 

16 here to debate what that level should be. We believe there 

17 should be a level below which there is objection to the 

18 human health and the environment. 

19 For lead in particular, a substance which this 

20 committee and the agencies report as a low carcinogen, we 

1 particularly believe that to be the case. Cancer, as we all 

22 know and you have been discussing this morning, is not \.\v 

23 principal end point of concern for lead. ACWA recognizes 

24 that. 

25 We also recognize the difficulty in building 

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1 those response relationships for these non-carcinogenic 

2 effects, some of them being very subtle and some "f them 

3 being very difficult to measure. 

4 Nevertheless, it is the association's strong view 

5 that the agency should not evade its responsibility for 

6 assessing health risks by establishing a zero health based 

7 standard. 

8 We believe there should be some finite number 

9 that the public, that the water utilities can strive to 

10 achieve, above zero, which EPA can establish and protect of 

11 human health and the environment with an ample margin of 

12 safety. 

13 This is the approach used by a lot of other 

14 federal agencies — FDA, CDC, world health organizations. 

15 There are numerical standards that are established which are 

16 protective of human health and the environment. We believe 

17 a similar type of approach should be taken with respect to 

18 lead. 

19 Now, make no mistake, ACWA is not in favor of 

20 lead in drinking water. That is not our objective at all. 

21 Rather we are just of the opinion that EPA should be able tv 

22 establish a level, other than zero, where exposure via 

23 drinking water is not believed to protect the publi'.1 health 

24 concern. 

25 ~" Only with- such a level, -first determined on. the 

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1 basis of the best available scientific evidence, will 

2 rational decisions be made on the appropriate controls and 

3 costs associated with drinking water samples. 

4 DR. UPTON: Thank you very much, Mr. Fensterheim. 

5 DR. LARSON: I have been quoted. That is not 

6 what our order said. Okay, the MCL's shouldn't be zero. We 

7 took --

8 MR. FENSTERHEIM: I was quoting the letter. 

9 DR. LARSON: No, it says it may be overly 

10 conservative. You took it out of context. It goes on. Our 

11 main concern that there was not the justification. It had 

12 to do with the document, not that it shouldn't be zero. Sc> 

13 when you took it out of context, you changed the meaning. 

14 We really took Jean Briskin to task on the health 

15 effects, mainly on the writing of it, and the fact that it 

16 wasn't justified. A lot of references to these documents, 

17 of course which you didn't have, but it was not our 

18 suggestion that the MCL shouldn't be zero. It is just a 

19 justification for it. 

20 DR. UPTON: Other comments or questions for Mr. 

21 Fensterheim? 

2 2 If not, thank you very much. 

2 3 DR. MUSHAK: I have a general comment. 

24 DR. UPTON: Paul, sorry. 

25 DR. MUSHAK:•- Does anybody know what the natural 

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1 level of lead in water is? We know what the natural level 

2 of lead in the soil is, but what about water? 

3 MS. LEVIN: It is below two. 

4 DR. MUSHAK: (Interposing) Parts per billion? 

5 MS. LEVIN: — Yeah, based on data I pulled 

6 together for the WHL book. 

7 DR. MUSHAK: Below two. It's very low. 

8 MS. LEVIN: Very, very low. 

9 DR. SILBERGELD: And then if you attempt to 

10 factor out the deposition from the airborne sources, it may 

11 be even lower, but it is extremely low. 

12 DR. UPTON: I would like to ask at this time 

13 whether Dr. Cogliano has additional remarks he would wish to 

14 offer. 

15 DR. COGLIANO: If you would like a brief summary 

16 of the RQ's, I can give that. 

17 DR. UPTON: What is the wish of the study group? 

18 THE STUDY GROUP: What is an RQ? 

19 DR. COGLIANO: I will tell you very briefly. RQ 

20 is under the Superfund Reportable Quantity Program. It is a 

21 quantity that if you release more than a particular amount 

22 into the environment, you have to call up the i:'e'|<>ral 

2 3 National Response Center. They will send somebody out. to 

24 the site to evaluate if some kind of action needs to be 

25 taken, if people need to be evacuated,.if alternative water 

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1 supplies need to be brought in, the substances needs to I >e 

2 or what would be appropriate. 

3 DR. HAMMOND: This is a part of EPA? 

4 DR. COGLIANO: Actually, the National Response 

5 Center is run by the Coast Guard under interagency 

6 agreement. 

7 In adjusting portable quantities, EPA uses six 

8 primary criteria: Cancer on which the Emergency Response 

9 Office takes the cancer evaluations directly from the office 

10 I belong to in Washington. Chronic toxicity is the second 

11 one. They take the chronic toxicity evaluations from our 

12 office in Cincinnati. Then acute toxicity, aquatic 

13 toxicity, ignitability and reactivity. 

14 The last four substances are evaluated by means 

15 of tables of LD-50s or flashpoints, and they were -- all of 

16 the substances — they can be evaluated very quickly. So in 

17 adjusting reportable quantities, the Emergency Response 

18 Office divided them into three groups. 

19 The first group were the substances which were 

20 not carcinogens, they were not chronic toxicants. They just 

21 looked up in a table all these values of LD50's and 

22 flashpoints and they promulgated RQ's, I believe, in 1904. 

2 3 The second group of chronic toxicants were 

24 promulgated in 1986. Lead was originally in that group and 

25 just before promulgation, it was pointed out to them there 

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1 was a lot of cancer data on lead so lead was pulled out of 

2 that group before promulgation and put into the third group 

3 of carcinogens. 

4 Carcinogens were done on a later track because we 

5 were waiting for the cancer guidelines that were promulgated 

6 in 1986 and it takes a longer time to evaluate those 

7 substances. 

8 Ellen, the last time you asked about lead would 

9 have dropped to 5,000 pounds if it wasn't for cancer, and 

10 that is true. It is because the reasons the chronic 

11 toxicity evaluation that was done was done in the early 

12 1980's, really before 1983. It doesn't take advantage of a 

13 lot of the information we know about lead since then. 

14 One shortcoming was the lead substances were not 

15 grouped together and considered as a class. For example, 

16 there were no or very minimal chronic toxicity or acute 

17 toxicity studies on metallic lead. We did not apply lead 

18 acetate, lead phosphate, all of the other substances to the 

19 reportable quantity for lead metal itself. 

20 I think that is something we would probably not 

21 do today. I think we would group them together, with 

22 perhaps differences in absorption but we would say i he 

23 effects we see form other lead compounds should apply to 

24 lead as well. 

25 Secondly, neurotoxicity was not included. There 

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1 are no -- in the chronic toxicity evaluation done in the 

2 early 1980's, IQ scores and any of those things we have been 

3 discussing most of yesterday were not included. That is why 

4 the reportable quantity for lead and metal would have been 

5 5,000 pounds. 

6 Other substances like lead sulfite also had been 

7 proposed at 5,000 pounds for similar reasons. There weren't 

8 studies on them and we did not see fit to apply the results 

9 from one lead compound to another. 

10 Now, lead has been pulled out of the carcinogen 

11 rules well to await this committee's deliberations on lead. 

12 After this committee is finished, we will be proposing or 

13 promulgating final reportable quantities for lead. I would 

14 like to suggest to this committee we will include cancer and 

15 I would like to ask the committee, in their written 

16 comments, for advice about whether the low potency 

17 characterization of lead is appropriate given what we talked 

18 about yesterday and last month. Or perhaps we should 

19 decline to make a qualitative characterization of lead. 

20 Secondly, we should do, I think, a new evaluation 

21 of the chronic toxicity of lead to include all. of the 

22 information we have had in the last several years. 

2 3 MS. BRISKIN: What do you du with tefra-ethy'l 

24 lead? 

25 DR. COGLIANO: -Tetra-ethyl lead, I_ think that 

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1 already had an RQ of ten pounds based on chronic toxicity, 

2 but I am not sure if it included the neuro-toxic effects. 

3 DR. SILBERGELD: I think this raises a general 

4 issue which touches on what Paul brought up, and that is it 

5 would be worthwhile, I think, for the Science Advisory Board 

6 to look into the whole RQ methodology. 

7 It essentially reveals the problems that all of 

8 us, and the agency of course, because they are on the front 

9 line, have with dealing with non-cancer effects. I think if 

10 you look into the RQ's — and I know this is arcane 

11 Washington jargon -- but if you look into the substances 

12 that fall into that middle category, you will probably be 

13 very disturbed about what has happened to them. Not so much 

14 for the implications for specific toxic chemicals, but the 

15 implied judgments about the importance of different kinds of 

16 systemic toxic responses. 

17 It is that generic issue that I think the SAB 

18 should get involved in and give some guidance to. I think 

19 you would agree the whole areas of neuro-toxicity and 

20 reproductive toxicity fair very poorly in the RQ system. 

21 DR. COGLIANO: That's right. Actually our 

22 environment --

23 DR. SILBERGELD: Irritants and sensitizers fair 

24 well. Ironically, the things that most of us would consider 

25 much more severe non-cancer health-.endpoints .are treated 

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1 very, very poorly. This is not out of any deliberate 

2 neglect but because of the lack of methodology that would 

3 guide that particular kind of very critical -- let me remind 

4 you — very critical response of the agency, immediate based 

5 response to deal with spills. 

6 DR. COGLIANO: These methodologies, we are always 

7 looking at them and I have talked to Chris DeRosa in our 

8 office in Cincinnati and he has some suggestions for how to 

9 change the criteria of evaluating chronic toxicity and I 

10 think he would be very receptive to some of your concerns. 

11 DR. MAHAFFEY: Just to amplify on this, I think 

12 the metals areas becomes particularly a problem because if 

13 we use mercury as an example, there is certainly evidence 

14 that even inorganic mercury over time can be mentholated in 

15 the environment. 

16 So changing the organic ligan will have a plain 

17 effect on the toxicity. I would be interested in how 

18 something like arsene is handled because the different forms 

19 of arsenic would have very different toxicities, arsene 

20 being quite acutely toxic. 

21 DR. COGLIANO: Arsene was only recently proposed 

22 to become a circla-hazardous substance so we haven't 

23 evaluated that. That is something we will be looking into. 

24 DR. UPTON: Yes, Dr. Larson. 

2 5 . DR. LARSON: Does the Coast Guard -- does it 

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1 somehow use NOAH in its evaluations as an agency. Somehow I 

2 got the impression that if it went out into the air, NOAH 

3 got involved. 

4 DR.- COGLIANO: I am not aware of NOAH being 

5 involved in this Emergency Response. They use our health 

6 evaluations. The Coast Guard contributes the expertise. 

7 DR. LARSON: There's a big center out in Seattle 

8 where the emergency response is NOAH based and any claim 

9 that if there is an air problem, the Coast Guard calls them. 

10 DR. COGLIANO: I am not really aware of that. It 

11 could be they have a piece of that too. I am mostly aware 

12 of the Coast Guard and EPA response teams. 

13 DR. LARSON: So again, when you are dealing with 

14 environments, it is a multi-bureaucracy. 

15 DR. UPTON: At time time I wonder if there are 

16 any other comments that agency personnel would like to 

17 offer, from any of the offices we heard from in the last 

18 couple days. 

19 DR. FRANK : I wonder if anybody wants to say 

20 anything about Solid Waste just to inform us and help us 

21 complete our picture. 

2 2 DR. GRANT: I think obviously it would be much 

2 3 better to have a representative of the office here and 

24 explain it.for you. 

25 DR. FRANK : What are the issues that Solid Waste 

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1 deals with and what are they responsible for? 

2 MS. LEVIN: I could outline the basic approach of 

3 the RICRA program and the basic approach of the Superfund 

4 Program and that might give you some context. 

5 Under RICRA, the Resource Recovery and 

6 Conservation Act, that governs the present disposal of 

7 wastes. That ranges from the manifest system where people 

8 who are transporting waste are supposed to attach labels to 

9 it so people know what they are moving around, to 

10 determining what is allowed to be put into what type of 

11 waste disposal, of what can go into land, what can go into 

12 other places. 

13 The standards for those disposal facilities--

14 whether or not landfills need liners, whether or not 

15 incinerators need scrubbers, that type of thing. And then 

16 corrective action. If for the existing disposal facilities, 

17 both hazardous waste and solid waste which is everything 

18 that is not hazardous. If the landfill, for example, has a 

19 leaking plume, whether or not that plume needs to be 

20 addressed and how clean the ground water needs to be cleaned 

21 up to would also be covered under RICRA. 

22 The Superfund Program handles much of the same 

23 materials -- wastes -- but it is the wastes that w° p out 

24 there before the program was enacted. Again, it is cleaning 

25 up hazardous waste facilities, to determine which facilitjes 

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1 need to be cleaned up and to what extent. 

2 The RQ program is again looking at releases into 

3 the environment and determining whether or not an immediate 

4 response needs to be taken. 

5 So there is the emergency response side and then 

6 there is the long-term clean-up side. So figuring out 

7 whether it is a hazardous waste, whether or not you can put 

8 it in the ground. If it is in the ground, does it need to 

9 be moved around somehow and if the facility is emitting 

10 pollutants, to what extent does that need to be cleaned up? 

11 The different programs there that you find listed 

12 on this thing -- EP standard, delisting, different mode.ls--

13 are all the different ways of evaluating risks associated 

14 with those different aspects of waste handling. Or if not 

15 quantitative risks, then setting relative priorities for the 

16 programs so they can take action. 

17 DR. HAMMOND: Mr. Chairman. 

18 DR. UPTON: Yes. 

19 DR. HAMMOND: I am not fully sure we can fully 

20 discharge our charge under the study group now or if we 

1 could even if we heard the presentations. What we need to 

22 do, I think, is to take the mass balance approach that we 

23 have identified in these charts and elsewhere where the lead 

24 gets into the environment, where humans may get it so we can 

25 understand what the remaining sources__are, and how much gets. 

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1 to people , and under the new rubric of risk-reduction which 

2 I am sure this administrator will pursue in advance, lead 

3 being a multi-media pollutant , w e have to have some kind of 

4 mass balance presented to us for the present, for the 

5 foreseeable future, and perhaps for the long term future. 

6 So that if resources are limited, as they are and will be, 

7 the agency can do the most risk-reduction by knowing which 

8 are the largest sources of environmental exposure and which 

9 are the most technologically feasible to reduce under 

10 current technology. 

11 So I think what this committee is going to need 

12 to complete its task is some integrated statement from 

13 somebody in EPA which addresses mass balance and 

14 transmission from sources to people. I think if the agency 

15 wants us to address land in that manner, we are going to 

16 have to get some technical support from somebody in the 

17 agency on mass balance. 

18 DR. UPTON: Dr. von Lindern. 

19 DR. VON LINDERN: I would also like to bring up 

20 one issue that we touched on a second ago. I have some 

21 familiarity with CERCLA, SARA and mercury programs. A note 

2 2 on this messag e from Offic e of Solid Wast e that, they, or- at2 3 least someone is developing a reference dose per lab, or 

24 examining that and is apparently going to base it on the 

2 5 - MCL. .-- -

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1 As I understand it, the MCL is a technology based 

2 standard. The MGCL has a zero goal. Is that consistent 

3 with the development of a reference dose? 

4 MS. BRISKIN: The reference dose would not be 

5 based on the MCL. The reference dose typically is a 

6 concentration or an amount of pollutant you would be exposed 

7 to in terms of milligrams per kilogram body weight for some 

8 unit of time. So that is not an MCL. That would come a 

9 step before. 

10 Traditionally, in the Drinking Water Program, we 

11 develop maximum contaminant level goals where here we 

12 proposed a zero for lead, but for other contaminants where 

13 we have non-zero goals, giving the data that is usual ly 

14 available, we use a reference dose approach. We look at a 

15 no observed adverse effect level or a no observed effect 

16 level, assuming that there is a threshold for the action of 

17 that pollutant, putting in some safety factors, and 

18 translating that into a dose. A reference dose would be the 

19 dose below which you would expect there would be no adverse 

20 health effects. 

21 From there, that is the starting point in the 

22 Drinking Water Program for developing a maximum contaminant. 

2 3 level goal for other pollutants and could be a possible 

24 point for developing, say, a soil lead clean-up number for 

25. the Superfund Program. 

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1 We have been working recently with the Oft ice - > I: 

2 Solid Waste and the Superfund office and Air and Research 

3 and Development to develop an approach that would let the 

4 wastes programs figure out soil lead clean-up goals. 

5 We have been working with them to explain about 

6 lead toxicology and appropriate ways to evaluate exposures 

7 to lead. In the Drinking Water Program, at least, we have 

8 rejected the RFD approach for evaluating health effects for 

9 lead. We are still working with the Solid Waste Office. 

10 They are coming to understand, I think, the notion <.> I: 

11 evaluation in terms of blood lead levels of concern. 

12 At last I understood that research and 

13 development was working pretty closely with them to develop 

14 an alternative approach which sometimes in slang still gets 

15 called reference dose because it is still an intake of lead 

16 that is associated with something. Where a reference dose 

17 is associated with zero risk, you could develop a dose that 

18 would be associated with or be calculated back from a given 

19 blood lead level of concern. 

20 So that is in the very preliminary stage? <<f 

21 development right now and I wouldn't reaily be able to 

22 represent their office and what they are thinking aI'cut 

23 using -- a reference dose approach or an alternative 

24 approach. 

25 DR. VON LINDERN: Is. it fair to say that there is 

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1 another risk assessment methodology developed out there 

2 within the agency at least that we are not aware of here. 

3 DR. GRANT: I am not sure you necessarily want to 

4 call it a different risk assessment approach or whatever. 

5 There exists, quite separately, with many questions in 

6 regard to lead, or whatever, a set of methodologies for 

7 evaluating both oral exposures and inhalation exposures, so8 called reference doses. 

9 I think Jean indicated the attempt was made to 

10 identify lowest observed amperspect levels or no effect 

11 levels. with appropriate modification, given information on 

12 whether it is from animal studies, human studies, high to 

13 low does extrapolations, areas of uncertainty nnyway--

14 modifying factors or uncertainty factors, essentially you 

15 come up with a margin of safety if you will below that and 

16 estimate some level that would be projected to have a very 

17 low probability of being associated with risk of an adverse 

18 effect. That's being done for a variety of other 

19 substances. As Jean noted, it is typically done or at least 

20 developed in light of the fact that for many, many 

21 substances we have very limited data bases or information by 

2 2 which to make judgments as to what might be safe. 

23 One of the issues right now is whether or nor. to 

24 do that kind of an exercise for lead. One of the 

25 interesting aspects, of it is that in fact and indeed, we 

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1 have quite a considerable data base on lead in comparison to 

2 any of these other substances. 

3 So it is now, in a sense, being discussed and so 

4 on as to would it not perhaps be much more effective and 

5 better to use that available knowledge that we have with 

6 regard to lead, both in terms of the health effect but also 

7 in terms of exposure, multi-media exposure relationships, 

8 plus the absorption factors by kinetic model, and to apply 

9 that instead of just coming up with some single number or 

10 something R&D made to shoot at. 

1.1 In that situation, in regard to the Superfund 

12 business, lead in soil is an obvious considerable important 

13 factor. And then to figure out what might be appropriate 

14 levels of lead or action levels or criteria for "clean'' 

15 levels in soil that you have to clean up. 

16 Some of the issues there that come into play and 

17 are beginning to be looked at or addressed include such 

18 things as bio-availability issues and so on. One of the 

19 things is lead in soil, depending on the chemical species, 

20 particle size, the soil characteristics, and so on. Lead in 

21 the soil on site perhaps the bio-availability or whatever 

2 2 may be different to some extent as far as rates < • (' 

23 absorption and so on from other substances. 

24 If so, and if there is a basis to project that, 

25 • would that perhaps mean- that site specific clean-up levn lbHeritage Reporting Corporation 

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1 may be more appropriate, rather than some single soil lead 

2 number. 

3 It is a bit of a complicated issue, if you will, 

4 with a lot of sub-issues pertaining to it. The agency is in 

5 the process of trying, in fact, to come to grips with these 

6 various aspects of the problem as I have just described. 

7 DR. VON LINDERN: I certainly appreciate the site 

8 specificity problems as well as anyone, I expect. But if I 

9 understand the Superfund public health evaluation 

10 methodology, in there will be some sort of allowable intake 

11 value if they develop this methodology for lead in the way 

12 that they have for other contaminants. 

13 That implies an allowable amount of absorbed lead 

14 per day. Isn't there certain implications involved with 

15 them doing that in light of the methodology that developed 

16 here yesterday, which is to project blood lead levels. 

17 DR. GRANT: Yes, there is an implication and what 

18 we all are hoping to be able to do, in fact, is to take 

19 advantage of what we have been working in connection with 

20 the Air Office and Water Office individual market and others 

21 in the modeling efforts, biokinetic modeling efforts and 

22 developing that further along and getting appropriate input 

23 parameters to' better take into account what would be soil 

24 lead contributions about and try to determine, under various 

25 - circumstances r what might, be appropriate. Let me just yivc. 

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1 you some impressions, yeah, okay, it may be a different 

2 answer as to what might be appropriate given, in fact, the 

3 levels of intake from other sources or the media under 

4 different specific circumstances. You might, and the idea 

5 of the site specific cleanup levels — 

6 DR. VON LINDERN: You mean intake versus uptake? 

7 DR. GRANT: Excuse me? 

8 DR. VON LINDERN: You mean intake — I'm 

9 confused. 

10 DR. GRANT: I didn't quite hear you. 

11 DR. VON LINDERN: Would you say that there's 

12 reason to develop allowable - different uptake amounts of 

13 lead in different populations or intake — absorbed intake? 

14 DR. GRANT: I think we probably all need to be 

15 coming up with some simple answer to what is an allowable 

16 absorbed dose. I don't think there's any disagreement with 

17 regard to that. That's an adverse effect. You come out now 

18 and start talking about allowable different amounts on the 

19 intake side or the exposure side from different sources -- I 

20 mean that's probably what we've all be talking about here. 

21 How do you do some kind of apportionate or whatever as to 

22 what may be allowed from different routes of exposure or 

2 3 sources, and we heard that we need to take into account the 

24 whole picture, the multi-media picture. And I think that 

25 applies to the soil lead situation,.perhaps more so- than, I 

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1 won't say more so, but very distinctly for sure in a sense 

2 in that instance. If somebody presents you with a high 

3 water lead level, a high air lead level or something, then 

4 you may judge that you have less room for maneuver say for 

5 soil lead than in a different situation with low amounts 

6 from the other sources. In order to not exceed the absorbed 

7 level. 

8 DR. VON LINDERN: I'm just expressing my concern 

9 directly and drop it at that. I suppose that most would 

10 agree that there is a theoretical absorbed dose that one 

11 could accept -- maybe some of us couldn't -- if one could be 

12 developed. 

13 DR. UPTON: I think that to complete our work 

14 today we'll need to have an opportunity to work in sub15 groups for a short time after lunch. It would be my 

16 suggestion that we do so until about 1:45 and reconvene, 

17 report back from the sub-groups and aim at adjourning for 

18 the day at 3:00 because people have airplanes to catch. So 

19 that my hope would be that within the next ten or fifteen 

20 minutes we can recess for lunch. 

21 I'd like to discuss with the study group the 

22 drafting group's report. I've got some thoughts about the 

2 3 proposal, but I think rather than pushing it out, I would 

24 like to listen to the reactions to my proposal. So I think 

25 if we're going to succeed in having the time we need to work 

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1 in drafting groups we will probably have to limit this 

2 discussion to another five minutes. And I see several hands 

3 up. I know that Dr. von Lindern hadn't finished his 

4 remarks, he was going to give us the bottom line, in his 

5 words. And there have been other hands up here, Dr. 

6 Wesolowski's hand was up, Dr. Mahaffey's hand was up and I 

7 think Dr. Mushak's. So I'd like to limit this to the next 

8 five minutes or so, whenever our recorder is ready to go 

9 again. All right, Dr. von Lindern. 

10 DR. VON LINDERN: I'd be happy to take this issue 

11 to the sub-group and make only one point. If the Office of 

12 Solid Waste does develop a methodology for AIC to follow 

13 their Superfund public health evaluation methodology, in 

14 order to do that they have to determine what's an acceptable 

15 intake rate. And that's something that this group and your 

16 group have struggled with for a long time and I would just 

17 like to point that out. 

18 DR. UPTON: Dr. Wesolowski. 

19 DR. WESOLOWSKI: I want to follow up a little on 

20 what Mort said, the committee really does need some kind of 

21 document that shows an integration and as one committee 

22 member I know of, Les, were apt to do that, he'd do his 

23 usual thorough and complete job and we'd have some enjoyable 

24 moments criticizing the finer things, but certainly would be 

5 proud of-the document— But Les may not want to take on that 

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1 responsibility. 

2 My question had to do with the fact the agency 

3 recently has given indications that they're going to take 

4 over human exposure, guiding scientific principles, risk 

5 assessment and risk management, and in fact I was upholding 

6 the program which limited the funding as much larger amounts 

7 of funding. I know that -they're not represented here in an 

8 exercise which involves total human exposure and I'm 

9 wondering whether it would be appropriate to consider them 

10 as the integrating force for the total human exposure 

11 problem. 

12 DR. GRANT: I think that — well, for one thing 

13 on total human exposure, the program, to date, has focused 

14 their responsibility more on other subjects like lead and 

15 metal and within the neuro context. For example, looking at 

16 indoor air as well as outdoor air. For example, so you can 

17 define it along that line. I seriously doubt that in terms 

18 of the resident expertise, shall we say, concentrated in 

19 different areas that would necessarily be — you know — to 

20 take on that kind of a job. There was a recommendation or a 

21 request or whatever to the committee but I think it's 

22 probably not necessarily very useful or fruitful for you to 

23 try to determine at the moment so specifically, what group 

24 within the agency should take it on versus a general 

25 recommendation, that some such integrated whatever should be. 

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1 done and then for us to figure out what would be necessary 

2 to do that, and who appropriate actors would be in helping 

3 perform that assessment. You know, I expect you would end 

4 up with an integration across several different program 

5 offices, offices of research and development and so on. 

6 Some type of an effort like that. 

7 DR. VON LINDERN: Yeah I agree it's not for me to 

8 say thanks to who, but in a sense this problem fits into 

9 that generic brainwork, doesn't it? 

10 DR. GRANT: Yeah, to an extent it does and as 

11 time goes on it may come to be addressed more in the context 

12 of that. It's just that historically it evolved more from 

13 looking at air toxins and what more metabolic or organic 

14 compound or something like that. In a total exposure, in a 

15 sense not just the indoor but outdoor air environment as 

16 well. 

17 MR. JORDAN: Gee, I don't think you have to 

18 stretch your eyes very far to see who'll be doing anything 

19 very quick. 

20 DR. UPTON: Dr. Mahaffey. 

21 DR. MAHAFFEY: A quick question about the soil 

22 lead levels that might be set. I can understand the need to 

23 know about bio-availability of lead in soil but would you be 

24 aiming towards setting a limit based on soil type and if you 

25 did set your- process, who would be responsible for 

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1 determining the bio-availability, the person having to clean 

2 it up or the agency? 

3 MS. BRISKIN: Just very quickly. I think that 

4 what I said was somewhat misinterpreted. We in fact will 

5 not set or do not set soil standards. We can — there are 

6 two efforts underway in EPA that are looking at the issue of 

7 what's a safe level in soil. One is the effort under the 

8 Cleanup and Outwork Program under the Office of Emergency 

9 Response. And the others are our support of HUD's 

10 activities that have we touched to do that. In addition, we 

11 have some modeling efforts underway, which is looking at 

12 some abbreviation of bio-availability issues. I do want to 

13 suggest that all of that is happening as a single standard 

14 setting activity. There are three distinct activities. 

15 DR. GRANT: To be sure, we at ORD do not have 

16 responsibility or authority or whatever to establish the 

17 level of the standard, but provide the technical support to 

18 the different program offices. 

19 DR. MAHAFFEY: But does anybody know if you did 

20 this who would be responsible legally? 

21 DR. GRANT: Ultimately, it's probably Osworth and 

22 the office that would have that responsibility. 

2 3 MS. BRISKIN: But not for paper for over the 

24 soil? I wanted to distinguish — there are high soil 

2 5 contamination levels in urban areas and that would not fall 

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1 necessarily under Superfund and so you just need to--

2 that's why I wanted to say that there are different 

3 activities that are currently underway and so you would not 

4 meet be a single standard necessarily. 

5 DR. GRANT: When Superfund was asked about this, 

6 they told us that all their science was done by R&D and 

7 whatever you guys decide, that's fine by them, they really 

8 didn't have much role to play in this and so on. Is that 

9 coordinated with what's happening in the cities? Is there a 

10 linkage to there? 

11 MS. BRISKIN: Yes. 

12 DR. GRANT: The Superfund, whatever - the bill13 SARA 3 whatever, included a mandate for the agency to carry 

14 out soil lead abatement demonstration projects, up to three 

15 FMA decisions. That responsibility overall falls to Osworth 

16 and the management of Superfund. They have drawn upon us, 

17 ORD, my office and others as appropriate, plus our mustering 

18 of outside experts, some of whom are sitting right here, in 

19 helping to provide technical support in developing protocols 

20 and an approach to doing these soil abatement projects. And 

21 they are now underway in three different locations - Boston, 

22 Cincinnati and Baltimore - and following a timeline, which 

23 we anticipate to produce some hopefully useful data or 

24 information somewhere out in 1991. We're likely to be 

25 getting—a full picture with the final reports in 1992. .. It 

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1 should hopefully tell us something about the effectiveness 

2 of soil lead abatement, whether new or other procedures for 

3 lowering lead in the soil. The effectiveness of that in 

4 reducing blood lead levels in children in the urban areas. 

5 So there is a definite tie in, in whatever integration or 

6 assistance going on between Osworth and the Office of 

7 Research and Development. 

8 Gary, the second area, the general issue of 

9 trying to develop soil lead standards or trying to come up 

10 with whether it's a single number or there should be 

11 different numbers for different situations, specifics and so 

12 on. Again, they are looking over to us to provide 

13 assistance in doing that. That's part of what we've just 

14 been talking about a little bit ago with Ian von Lindern in 

15 terms of response to his question of efforts along those 

16 lines. 

17 DR. MUSHAK: As a follow up to Ian's question, 

18 this business of the certain Superfund site in northern 

19 Idaho which shall remain nameless. That was evaluated by 

20 Region X. And we have involved a few things in it. 

21 DR. GRANT: Paul, you can't use data intake 

22 because that's a scale primarily for chronic lifetime 

2 3 exposure. 

24 DR. MUSHAK: Also in that exercise, the Agency 

2 5 kind of adopted the notion that lead shall be viewed in. a 

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1 sub-chronic sense. A two-year old child shall be the object 

2 of risk and assessment. So that in terms of how Osworth 

3 interacts with how lead is to be handled, it's already taken 

4 — in terms with EPA. So can you come up with an ADI that 

5 going to keep anybody happy? Yes, I think that question's 

6 been answered. 

7 DR. SILBERGELD: Again, it's the definition of 

8 what is a hazardous waste? Then come up with a definition 

9 which is based on the leechability of lead and an incredible 

10 multiplier of the existing drinking water supply. I think 

11 people should be aware of it. 

12 DR. GRANT: Now that's true Ellen, it is true. 

13 DR. UPTON: I think unless there are pressing 

14 comments or questions that have to come out at this point, I 

15 would like to express on behalf of the study group thanks to 

16 the agency spokesmen who have so effectively briefed us 

17 during the last couple of days. I've been immensely 

18 impressed with the quality of the written and verbal 

19 material that we've been privileged to review. 

20 I don't know how many of the agency people will 

21 come back when we reconvene at 1:45. Certainly you're all 

22 welcome and invited. But unless some of you will not be 

23 here, let me again thank you very much for your efforts. 

24 Now I would like to propose that the members of 

25 the study group divide themselves..into four sub-groups and I 

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1 have thought about this in relationship to the major issues 

2 that are to be addressed by the study group. The first one 

3 includes the problem of carcinogenicity, the weight of 

4 evidence classification, and how the issue is dealt with in 

5 the air quality levels. And I would propose that a sub6 group consisting of Drs. Frank, Hammond and Upton look at 

7 this problem and try to develop a couple of paragraphs, at 

8 least key bullet type statements that reflect the findings 

9 and conclusions of the study group and the recommendations 

10 that we might care to offer. Try to be responsive to Dr. 

11 Cogliano's plea at the last moment for advice. 

12 The second sub-group look at the treatment of the 

13 health effects, other than cancer, including such matters as 

14 sensitive sub-groups in the air quality documents. We're 

15 trying to get closure on the air quality documents. This 

16 issue of how one handles the non-carcinogenic end points I 

17 would hope might be referred to a sub-group consisting of a 

18 sub-group consisting of Drs. Chisolm, Rabinowitz, Silbergeld 

19 and Weiss. 

2 0 The third sub-group I would propose to concern 

21 itself with exposure and exposure dose models, the 

22 assessment of those matters, again taking into account such 

23 relevant considerations as sensitive sub-groups, different 

24 sources, different media of exposure, 

25 bio-availabilities, efeciation^ there are a- family- of issues 

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1 that have to go into the models. And I would suggest for 

2 that sub-group that it include Drs. Carlson, Larson, and 

3 Mahaffey. 

4 And then a fourth sub-group I would ask to 

5 propose to look at cross-agency consistency, coordination 

6 and other relevant issues which have been raised, the mass 

7 balance matter for example. The need for an integrated data 

8 base. And here I would like to propose that the group 

9 include Drs. Lippmann, Mushak, von Lindern, and Wesolowski. 

10 So that would be the chairman's effort to try to 

11 harness the impressive talent of expertise and experience of 

12 this study group to address the issues our charge has given 

13 to us. My suggestion would be if the study group was 

14 amenable to this proposal, that we eat lunch quickly, go 

15 into sub-groups, work together in sub-groups, bring back 

16 some written bullet-type statements, and when we reconvene 

17 at 1:45 aim to have some discussion of these, interaction 

18 with staff and adjourn, start heading for the airport at 

19 3:00. I'm told by Dr. Barnes that there are other rooms, 

20 other areas in which sub-groups might work separately, but 

21 that's my proposal. And I open it up for reactions. It's 

22 on the table. Any counter suggestions or modifications? 

2 3 .DR. UPTON: Question. Yes. 

24 DR. YODER: Yesterday, Dr. McClellan suggested 

25 that you're still very much interested in input from the 

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1 public. Could I ask how your reports this afternoon would 

2 be - or how public comments would be worked into the report 

3 that you would be developing this afternoon? 

4 DR. UPTON: Obviously, the reports that we'll 

5 develop this afternoon will reflect everything we've heard 

6 today as well as comments which were received in advance of 

7 our meeting, at the time of the March 30 meeting. My 

8 understanding, and I think the doctor had emphasized earlier 

9 that really to complete the response to our charge we need 

10 some additional information. And I think Dr. McClellan 

11 assured the audience yesterday that the comment period 

12 remains in force so that no completion can be envisaged 

13 until the end of the comment period, as far as I'm aware. 

14 DR. BARNES: In talking about Dr. McClellan 

15 yesterday, his suggestion is that when the comment period 

16 closes the program will gather all those comments and make 

17 them available to study group prior to the submission of 

18 their report. 

19 MS. BRISKIN: I noticed that in your assignments, 

20 there is in fact one issue that is not very well covered in 

21 terms of the charge that was given to us, and in fact, I'm 

2 2 not sure that we can cover it but I would hope perhaps that 

2 3 we could send at least a formal statement about our 

24 inability to cover it. That's point number three, which has 

25 to do with our judgment of the consistency of what's going 

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1 on. I would suggest that it's said to be on drinking water. 

2 The consistency of.what's going on within the agency with 

3 respect to the lead, since in fact we did not have a 

4 complete opportunity to hear everything that's going on with 

5 respect to lead we really can't address that. But perhaps 

6 we could note that, that we weren't able to deal with it in 

7 part because it's a very large topic but also that our 

8 efforts were hindered by the lack of presentations. 

9 DR. UPTON: Good point. I would hope that the 

10 fourth sub-group that addresses specifically cross-agency 

11 consistency, coordination with other relevant issues, would 

12 do exactly what you've suggested. 

13 If there are no further comments now, then we 

14 stand recessed until 1:45. 

15 (Whereupon, the meeting was 

16 recessed, to reconvene this 

17 same day at 1:45 p.m.) 

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1 AFTERNOO N SESSIO N 

2 DR. UPTON: i think we're all assembled again. 

3 In view of the hour, we have only an hour left. Cabs are 

4 coming and people will have to begin to move away to the 

5 airport. We want to ask each of our drafting groups to 

6 respond. Let me clarify what we're trying to do at this 

7 particular time. The emphasis is on a summary of the key, 

8 the findings, conclusions, recommendations that have emerged 

9 during the past two days. 

10 It was pointed out to me, after we recessed this 

11 morning, that it was the understanding of a number of the 

12 members of CSAC that we had really essentially come to 

13 closure on the Air Quality Document so that remarks that are 

14 being made this afternoon address broader issues, not that 

15 they have no relevance to the Air Quality Document but 

16 address broader, more generic questions. I think with that 

17 introduction, I wonder if we could call first on group 

18 number four that was dealing specifically with cross-Agency 

19 issues. And I'm not sure who will report, whether it will 

20 be all of them or one.. 

21 DR. LIPPMANN: I guess I was taking the notes, so 

22 with the indulgence ot my associates, I will give you a 

23 report. We concluded that there was a striking lack of 

24 consistency in the preparation for this committee's review 

25 and the documentation provided to us by -the various program 

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1 offices. Whereas the Office of Research and Development and 

2 the Air Office gives extensive documentation and made the 

3 review relatively easy to address and the Water Office at 

4 least showed up and was prepared to engage in some 

5 clarification and discussion of the issues. Several program 

6 offices who are likely to account for an increasing amount 

7 of vote here in the future, Pesticides, Toxic Substances, 

8 Solid Waste, Superfund, Emergency Response Office, gave us 

9 no information on which to form a judgment — consistency on 

10 many of these issues. 

11 Therefore, as we review the other issues for 

12 consistency, we can really only focus on the consistency 

13 between ORD, Air and Water to any extent and the others we 

14 have a caveat up front that we can't fully address the 

15 consistency. 

16 With regard to other more specific issues, there 

17 was certainly a consistency in the health effects index 

18 which is used for lead and that is for blood lead. 

19 Certainly Air and Water appeared to be very consistent in 

20 accepting blood lead level and being indicative of excessive 

21 exposure and likely health effects. 

22 In terms of target value for blood lead as an 

23 indicator, again the Air and Water Office had explicitly 

24 said that they would be here. We don't know about 

2 5 -consistency in other program offices there-,—plus we weren't 

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1 told about it. 

2 In terms of the population at risk, again, there 

3 was a general consistency as far as we could tell that it 

4 was children who were judged to be the population at 

5 greatest risk, but we note that there was some apparent 

6 inconsistency about the age of the children of the most 

7 sensitive group. Again, both Air and Water and we don't 

8 know about the other areas. 

9 There was even between Air and Water, however, an 

10 apparent inconsistency in the percentage of the population 

11 who can be in exceedance. The Air Office appears to talk 

12 about 95% of the population being within the lead in water 

13 target as being how they will proceed, whereas the Air 

14 Office gave us a series of percentages generally higher than 

15 95% in terms of the air standard. So there is an apparent 

16 inconsistency with those two programs and probably other 

17 inconsistencies between the program areas. 

18 In terms of the consistency of the exposure 

19 models, there was an apparent lack of consistency, at least 

20 as far as we can tell, there may be inconsistency of some 

21 elements, like analytical methods, but sampling protocols 

22 did not seem to be on a consistent basis. There was no 

23 addressing of important issues like bio-availability, in 

24 terms of data on the activity levels of water, how much 

25 water was consumed was inconsistent with the assumed air 

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1 bodies, questions like that. 

2 But basically, we note an important thing that 

3 needs to be considered in the exposure models is the 

4 allocation of the overall blood lead burden through the 

5 various media. Each of the Air and Water Offices has more 

6 or less adopted a permissible fraction on their own, as far 

7 as we can tell. Water appears to be willing to accept for 2 

8 micrograms per deciliter of the body burden, explicitly. 

9 Air was a little less explicit as far as their stand and the 

10 other offices we don't know. 

11 We really are groping when we look at consistency 

12 on risk reduction strategies. We heard elements of each 

13 from Air and Water, but it's difficult for us to judge their 

14 consistency. Again, we don't know the other program 

15 offices. 

16 Risk communications — it's likely that there are 

17 inconsistencies but again we don't have enough information 

18 to judge that. 

19 We recommend two actions to the Administrator, in 

20 terms of our recommendations in this area. One, that a 

21 thorough mass balance be conducted on current levels, flux 

2 2 and so forth. But extending back into the past and forward 

23 into the future as well, because of the knowledge that the 

24 balance element has been changing in the past and are likely 

25 to be changing.-.in...the future. And then more generically 

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1 still, we recommend that the EPA develop a national lead 

2 policy. Thank you. 

3 DR. UPTON: Are there any comments from members 

4 of the sub-group? Questions from the study group? Anyone? 

5 Mr. Jordan. 

6 MR. JORDAN: On the mass balance, you're thinking 

7 from a source standpoint? Okay. 

8 DR. LIPPMANN: One of the strengths of the source 

9 is the transporter routes and rates, presentation of a 

10 burden to target the Agency. 

11 MR. JORDAN: Then on what scale? National scale 

12 or geographical scale or what? It could go either way, but 

13 it's very difficult. 

14 DR. LIPPMANN: You didn't address it. 

15 MR. JORDAN: Okay. 

16 DR. LIPPMANN: It's up to you to interpret it. 

17 (Laughter) 

18 DR. LIPPMANN: There are some other somewhat 

19 subtle differences if you read the Federal Register. Notice 

20 on the drinking water, they for instance don't have any 

21 mention of blood pressure and lead level which would seem to 

2 2 be important based on what was in the other documents. They 

2 3 also pay a little more attention I think to carcinogenicity 

24 as one of the reasons for making zero as the LP. And those 

25 two things aren't- necessarily bad, they need to be 

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1 straightened out at least within the agency so that -- Now 

2 they do focus also on the neurotox procedure, what we 

3 focused on yesterday. So there is some consistency, but it 

4 could be better. 

5 DR. VON LINDERN: Well, we didn't address that at 

6 all. I guess I was operating on the premise that the 

7 various effects which were discussed in the context of the 

8 error are applicable and then how it gets to the point. 

9 DR. LIPPMANN: That's true. And that's 

10 conclusive. Why they couldn't decide, there were still some 

11 problems. It may be because it was done before the 

12 documents were complete. We're going back to last summer, 

13 last year. 

14 DR. VON LINDERN: Okay. The Air and Water 

15 documents used different end points. How do you define --

16 DR. LIPPMANN: Used some of the same but not 

17 necessarily — same. 

18 DR. GRANT: I think the accurate statement is 

19 that the attempt was made to have consistency between them 

20 and certainly the main focus in these is on the neurotoxic 

21 and early fetal development, whatever you call that. And 

22 where there may be a difference would be on emphasis. For 

2 3 example, the discussionis on carcinogenicity in one more so 

24 than in the other. And then the blood pressure, I'm not 

25 sure if it was totally left out of one of .the documents but 

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1 it was probably highly focused on children as the key --

2 DR. LIPPMANN: The number one point we're making 

3 at zero is number one, as far as the way they listed, was 

4 the lack of threshold for ALD dehydrates. 

5 DR. VON LINDERN: It says, listed under the major 

6 points for the toxicity. That's one that might be any 

7 number of points ;— but it reads funny. It's just this type 

8 of thing. And I'm sure this only, when they come to the 

9 final rule, I'm sure it will be better and I just wanted to 

10 give us that remark. 

11 DR. UPTON: We're getting into exposure modeling, 

12 exposure risk relationships and I wonder if we could hear 

13 from the third sub-group that had to do with this whole 

14 series of problems such as exposure, bio-availability, 

15 speciation and so on. 

16 AUDIENCE MEMBER: Dr. Upton, before you go on, 

17 could I make one remark about consistency? 

18 DR. UPTON: Sure. 

19 AUDIENCE MEMBER: This may not need saying, but I 

20 feel some urge to say it anyway that as to how the different 

21 programs go about setting standards, it should be remembered 

22 that the different offices work under different statutes and 

23 the basis for standards is different and to give perhaps the 

24 strongest example, if one office is setting standard that is 

25 based on health effects, you will get one result. If 

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1 another office is basing a standard on available control 

2 technology, the chances are that you'll get a different 

3 result. And of course the discussions leading up to the two 

4 standards will focus on different things. So to some 

5 extent, a wish for data consistency may need to be addressed 

6 to Congress and I just urge that you keep in mind that there 

7 may be those differences.-

8 DR. UPTON: Thank you. Dr. Carlson. 

9 DR. CARLSON: Yes. What you're also pointing out 

10 is the difference in the NCLG and the NCL for the drinking 

11 water. So I generally, the things that Dr. Larson 

12 talked about yesterday in that report covered a lot of 

13 feelings with regard to the overall acceptance of this 

14 document, the exposure analysis methodology validation. And 

15 generally felt that the review of the National Standard Air 

16 Qualities, standard for lead, exposure analysis methodology 

17 and validation, serves as a regional model on which to 

18 build. Our real concern was that's not the be all and the 

19 end all but it seemed like a good place to go and it 

20 provided means for identifying gaps in knowledge and areas 

21 for additional research that could someday have answers, 

22 such as writing the report. But it's really true in the 

23 sense that after discussion in the last couple of days we 

24 realize that there are some points that we make that are 

25 pretty -- and others we really have a difficult time 

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1 dealing with. 

2 As far as sensitivity goes, this is a difficult 

3 issue, obviously. We've been talking about it. The mother4 fetal unit certainly presents a sense of the population. 

5 However, unless we use extreme assumptions of transfer of 

6 environmental leads on transfer of environmental lead to the 

7 mother and into the fetus. It's problematic to focus on 

8 this. Furthermore, there are few data sets on fetal tissue 

9 that could be used to address the question. And some of 

10 these imply the questionable methodology and the 

11 questionable methodology really refers to the age of these 

12 studies rather than -- at their time they may have been all 

13 right. 

14 Fortunately, there is research now on projects 

15 utilizing Australian populations near lead smelters that 

16 should provide some of this data. Dr. Mahaffey talked to us 

17 a little bit about this and this is a very extensive study. 

18 It is very difficult, so we should get some information that 

19 you would be able to plug into these models, if you want to 

20 use that mother-fetal unit as a sensitive population. 

21 We endorse the multi-media model. It should be 

22 of such a nature to recognize that the age of the sensitive 

2 3 group may change with media, that is at three months, as Dr. 

24 Chisolm pointed out this morning, that at three months water 

25 may be the most important group for.. exposure and later on 

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1 though when you have the type that are crawling around on 

2 the floors and into the dust. It is noted in the document 

3 time spent indoors and outdoors also varied greatly with age 

4 and should be considered. We got in a big discussion today 

5 about the Drinking Water people using a certain age group 

6 perhaps, and Dr. Marcus' report was six and a half months, 

7 and the document on the air was two years. Those are not 

8 necessarily inconsistent if you consider the importance of 

9 the different exposure medium. Which is really what we are 

10 after. 

11 Speciation is important in distinguishing organic 

12 from common lead. However, it is suspected that some 

13 populations or subspecies may not be that useful. Jim isn't 

14 here, I know he presented that slide yesterday, and that 

15 really had some interesting information on it but the 

16 differences among speciation within the organics is not much 

17 compared to the tetra-ethyl lead versus the inert solubles 

18 in organic salts versus lead metals. It would be more 

19 profitable to spend more effort on the influence of 

20 particulate, of a particle size on absorption 

21 characteristics in the form of a salt. Finally, further 

22 studies on the acquisition of data to correlate exposure 

23 with blood levels, as much information as possible regarding 

24 exposure conditions by whatever route practices best. It 

2 5 - •needs to obtained by the agency to better understand the 

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1 relative source contributions- This seems to be in this 

2 modeling business, you go and you look at the contributions 

3 and things that are already involved this morning, the 

4 inquiry uses 20% as a default value, unless they can justify 

5 a different number, that's what they use. I'm not sure, I 

6 should know, but I apologize for that. Whether or not 

7 that's what they did this time. But they often do that. 

8 Many of the times, that's what they do because they don't 

9 have the data and we should really be there collecting that, 

10 the exposures by the various sources and comparing those to 

11 the blood levels of paint rather than just obtaining blood 

12 levels and then not being able to attribute any sort of 

13 source contribution. 

14 DR. UPTON: Thank you very much. Other members 

15 of the drafting group? Dr. Mahaffey is not with us. Dr. 

16 Silbergeld? 

17 DR. SILBERGELD: It would be useful if you would 

18 address this issue which comes up in the Staff Paper between 

19 sort of responsive populations and susceptible populations 

20 and causes potential for confusion in those terms and also I 

21 think each one raises separate scientific issues. What the 

22 Staff Paper identifies as populations most likely to respond 

23 to a change in an external source term, as well as 

4 populations most likely to respond in a biologic sense to a 

25 given exposure. — . 

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1 DR. UPTON: Other comments? 

2 We're seeing, I think, in the last couple of 

3 days, what amounts to new and vexing but increasingly 

4 important series of issues dealing with non-carcinogenic 

5 effects for which there appears to be risks of lower levels 

6 of exposure and I wonder if we could call on the second sub7 group to share with us its thoughts on * the how the agency 

8 can best approach this category on the the next issue. 

9 DR. GRANT: We have four reports. 

10 DR. WEISS: I wonder if it's necessary for me to 

11 read everything that I wrote, but I began with the assertion 

12 that we typically define an adverse effect by its expression 

13 in residuals, for example, in cancer cases. But with 

14 neurotoxicgens, we face another kind of interpretative 

15 problem because as you saw from the document what we really 

16 have to contend with is the expression of risks posed by a 

17 shift in the distribution of some end point. For example, 

18 IQ scores. And even small shifts in the mean are amplified 

19 greatly when you look at the extremes of the distribution. 

20 A shift of 5 IQ points or 5% for example in a population of 

21 a hundred million, changes the number* of individuals with 

22 IQ's above 130 from 2.3 million to 990,000, with a 

2 3 corresponding expansion of the number of individuals with 

24 IQ's below 70 which is an important legal value for 

25 . intervention-in the schools-. As a result of this reason^- it 

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1 makes the most sense for regulatory decisions to formulate 

2 risk in terms of shifts and distribution. Similar 

3 distributions or similar expressions of risk I think would 

4 also help visualize the total impact of relatively small 

5 displacements of the blood pressure distribution. We 

6 recommend that the supplement treat risk in this way in the 

7 next draft, perhaps with an accompanying table showing the 

8 proportion of children corresponding to postulated shifts in 

9 the mean of intelligence tests scores. Such a scheme 

10 presents the Administrator with a clear statement of the 

11 consequences stemming from any specific choice of a targeted 

12 blood level. In addition, such an approach makes it 

13 unnecessary to use terms such as level of concern which 

14 appears throughout the document and which to some readers 

15 might imply support for the concept of a threshold. 

16 DR. UPTON: Comments? 

17 DR. GRANT: Bernie, let's be sure — are you 

18 referring to levels of concern or whatever in relation to 

19 what's in the supplement versus in the Staff Paper? 

20 DR WEISS: It's in both. Yes, we discussed what 

21 level of concern, then, and we have four different 

22 interpretations. 

23 DR. GRANT: We settled with attempt to add 

24 additional information as we noted yesterday that you were 

25 trying to da. I can't give you an absolute definite topic 

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1 as to what will be the outcome of this because it's highly 

2 dependent upon what some of the research groups, for 

3 example, are going to be able to do for us, to provide for 

4 us. It's as simple as that. We don't have the data in our 

5 hands, we don't have control of the data and so forth, and 

6 we will be highly dependent on the cooperation to the extent 

7 that it's possible to get it. 

8 DR. WEISS: Perhaps you change the way you stated 

9 it to another kind of formulation. For example, a statement 

10 to the effect that adverse effects have been observed at 

11 levels as low as, say, 10 to 15. But there's no 

12 documentation here or no cogent documentation to allow you 

13 to examine the risks at blood levels below those values. So 

14 you can only hypothesize depending upon how you extend the 

15 dose effect function, as to what the actual risks might be. 

16 DR. GRANT: I think we can certainly attempt some 

17 kind of reworking of language that gets towards that 

18 conveying on the level of competence, where there's lack of 

19 sufficient information or softer information, we can build 

20 in something on that. 

21 DR. UPTON: There were other members of the sub2 2 group. Do we have comments from others? 

23 DR. SILBERGELD: We also treated the issue of 

24 incorporating the experimental studies and both Mike 

25 Rabinowitz and I wrote some comments-on that. What I wrote 

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1 dealt with essentially with the justification for looking at 

2 the experimental data because, as was noted here, it can 

3 support the human studies remarkably. First off, there's a 

4 lot of in the case of lead. It supports the human studies 

5 providing confirmation both of the kind and quantitatively 

6 as well of the observations that have been made in those 

7 human populations and it has the advantage of eliminating 

8 many of the confirming variables which are inevitably 

9 present in those human studies. And also very importantly, 

10 the experimental data provide a mechanistic basis for 

11 developing health-based goals to reduce toxicity. So we 

12 recommend that the addendum summarize recent studies, 

13 particularly those incarnates and also look at the recent 

14 mechanistic studies in conjunction with inferences from the 

15 basic neuroscience on events in neurogenesis over the late 

16 fetal and early neo-natal period. We conclude that these 

17 experimental data are a basis for proposing that there's 

18 likely to be no lead threshold for lead neurotoxicity at 

19 least over the contemporary range of levels of exposure, 

20 i.e., from 1 through 29 grams per deciliter. We would like 

21 some kind of statement in particularly in response to your 

22 comments, Dr. Upton, about the perspective here that the use 

23 of mechanistic data in risk assessment is in effect a long 

24 established- practiced. And we're presented with an 

25 opportunity,—because- of-the richness of data on lead, to go 

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1 beyond the standard practice in non-carcinogen risk 

2 assessment of using low L's and no L's in developing health3 based goals. Therefore, we would urge the agency to explore 

4 the mechanistic models specifically available from the lead 

5 data for risk assessment for this purpose. 

6 DR. UPTON: Thank you, Dr. Silbergeld. Paul? 

7 DR. MUSHAK: I would think it would be importance 

8 in that regard, that is connection with a mechanistic study, 

9 to look specifically or to highlight evidence for 

10 irreversibility of the facts. Of course, I've come back to 

11 this matter as some of the neuromaturational studies. 

12 DR. SILBERGELD: I think we meant to point to 

13 that when we talked about linking that to what we now know 

14 about neurogenesis and I think that that's exactly right. 

15 DR. UPTON: DR. RABINOWITZ 

16 DR. RABINOWITZ: Overlapping areas of interest 

17 here. what I want to say is although the supplement 

18 includes grading on the available information of the health 

19 effects in the Criteria Document, some gaps need filling. I 

20 wonder whether the lack of recent animal studies would shed 

21 light on possible mechanisms of lead toxication. But of 

22 particular importance is the usefulness of these studies as 

23 a basis for downward extrapolation of dose effects of lead 

24 from the human studies which generally involve doses of lead 

25 in excess of the current range--of- interest,, less, than 15 

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1 micrograms per deciliter. It's a range with precious little 

2 data. 

3 Other areas of health effects not adequately 

4 discussed in the supplement include blood pressure and the 

5 diagnosis of hypertension among women; infants, minor 

6 congenital anomalies which may be markers for the 

7 interference with other less physical systems such as the 

8 nervous system and which show no threshold of detectable 

9 effect. The effect of lead on birth weight and in the 

10 extensive animal literature deserves more explicit 

11 presentation, depressed birth weights, head size, body size, 

12 may be considered health end points on their own aside from 

13 their role as a mediators of other effects. 

14 DR. UPTON: Thank you. Comments? Dr. Chisolm? 

15 DR. CHISOLM: This carries on with what Dr. 

16 Carlson had to say. The most sensitive population may 

17 differ for different environmental sources of lead. For 

18 example, with regard to dust lead, drinking water lead in 

19 early life, sensitive population differs for different 

20 developmental and biological reasons. The mobility and the 

21 prevalence of normal human activity make the 12 to 36 month 

22 olds the most sensitive for dust lead. By contrast, water 

3 requirements vary with age, the highest from birth to 3 

24 months of age. Primarily, though, this age range has the 

25 highest -growth rate, —the highest -metabolic rate and the 

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1 greatest rate of maturity. Water can be calculated on the 

2 basis of body weight, preferably on the basis of water 

3 requirement to which the requirement is attached. Therefore 

4 the 3 month old should be selected as critical to the 

5 drinking water while 24 months would serve more about dust. 

6 Similar considerations with regard to water may well apply 

7 at the geriatric end of the age spectrum in relation to 

8 diminishing function. Studies in aging rats, for example, 

9 also indicate with normal demalnurization that there is the 

10 translocation of lead from bone primarily to the brain and 

11 kidneys. And that's the reason we're just not going to 

12 accept it. 

13 DR. UPTON: Thank you very much. Comments? 

14 Questions? Anyone? 

15 DR. GRANT: Yesterday we discussed at the end of 

16 the CASAC review or whatever, the recommendations or 

17 whatever which are very similar to what, essentially the 

18 same as what you are saying now. We certainly will go back 

19 in there and take a look at several of things that you've 

20 just noted. For example, as I indicated to Bernie 

21 yesterday, we will look at the data and information 

22 concerning the animal studies, things like the Rice study 

23 and so forth and bring into the addendum information along 

24 that line. We'll take a look at some of the mechanism stuff 

25 as well. - As I indicated to Mike yesterday, things such as 

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1 studies on the blood pressure in women, pregnant women, and 

2 so on. So we'll certainly take those into account and try 

3 to bring them in here. 

4 I will repeat what I said yesterday, and one 

5 test, besides the fact that we do not intend to an all6 comprehensive totally all-inclusive kind of literature 

7 review or whatever. What we are talking about here and what 

8 I'm saying that we're going to try to do is indeed to focus 

9 in and present enough information on the subject to get 

10 across the main points and to illustrate them, or whatever. 

11 Just so that there's no misunderstanding here on the part of 

12 all of us as to what we intend to do. 

13 DR. UPTON: I think we can then move on to the 

14 first and last of the sub-groups on carcinogenicity, looking 

15 particularly at the document and attempting to respond to 

16 Dr. Cogliano's inguiry about further elaboration of the risk 

17 assessment, qualification, etc. Dr. Hammond. Dr. Frank. 

18 DR. FRANK: The evidence that lead is a human 

19 carcinogen should be amplified, in both the AQCD supplement 

20 and the OAQPS staff paper. Both the paucity of 

21 epidemiological evidence with which to attempt quantitative 

22 risk assessment and the uncertainty surrounding the use of 

23 extrapolation from the high level animal exposure studies 

24 currently available to predict human risk of cancer should 

25 be amplified— Justification for the emphasis on non-. 

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1 cancerous adverse effects, especially those involving 

2 cognitive functions and neurotoxicity, effecting the 

3 youngest elements of a population should also be spelled out 

4 in greater details as part of this implication. That is, we 

5 didn't recall a simple comparison of the two age groups that 

6 might be involved on the one hand on these non-cancerous 

7 effects, people at the beginning of life, and those that 

8 might be involved with renal cancer, people my age. 

9 Secondly, the evaluation made of the available 

10 epidemiological data by Drs- Mack and Shanker in the 

11 handouts that all of us got upon arriving here, should be 

12 reflected in the two documents as part of this exercise. 

13 And third, and lastly, in the future 

14 consideration should be given to Dr. Lippmann's 

15 recommendation, and this is apart from the Air Quality 

16 Criteria Document, to Dr. Lippmann's recommendation 

17 concerning monitoring of the incidence of renal carcinoma as 

18 it may be influenced by reduced emissions from translocation 

19 and other sources. That is, in the next one to two decades 

20 this effort would of course involve elements both of 

1 retroactive data analysis and future data collection. 

2 2 DR. UPTON: Thank you, Dr. Frank. Dr. Hammond, 

2 3 any --

24 DR. HAMMOND: No, other than for the benefit of 

2 5 those who have not had- a chance to read the report on the 

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1 March 30 study, I think that Dr. Mack's focusing on the 

2 renal tumor incidence rather than on the lung tumor or the 

3 gastrointestinal tumor simply results from the fact that in 

4 those epidemiological studies — there was never any 

5 adequate controls for smoking, for ethnicity or dietary 

6 habits, which do substantially influence the incidence of 

7 those other two kinds of tumors for which there is some 

8 elements of an elevated incidence related to lead. So 

9 that's the reason for the focus on the renal. I gather, 

10 though I don't know this, but Dr. Mack felt that a renal 

11 tumor is indeed something that occurs more or less 

12 independent of smoke the disease compounds. 

13 DR. UPTON: Comments, anyone? 

14 DR. FRANK: It's a little confusing when you just 

15 now said Paul. From yesterday, I thought it was mentioned 

16 that smoking did contribute to renal tumors and although it 

17 was low it was not necessarily very rare for certain types 

18 of tumors. Maybe we misunderstood. 

19 DR. UPTON: I think the question came to me and 

20 it was my recollection that there was an elevated relative 

21 risk in smokers, although maybe not highly elevated. Dr. 

22 Mack would certainly know better than I. It's his opinion. 

2 3 When you think about age, Dr. Frank, I am 

24 reminded that at NYU we have a professor who will be 101 

25 -this month and he--gets out of bed everyday. Still very 

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1 sharp, very productive, very active. 

2 DR. FRANK: Dr. Upton, and I think the reason he 

3 lived that long is that he never had any lead in the water 

4 he drinks. 

5 (Laughter.) 

6 DR. UPTON: Well, the discussion groups have each 

7 made their reports. I wonder whether there is anything 

8 else. The Dr. Barnes reminds me that he would hope to 

9 receive from those who have reported their handwritten notes 

10 so that they can be typed up and made available to CASAC and 

11 this Joint Study Group. 

12 I think if there are no other items of business, 

13 I would like to thank those who have labored to make this 

14 meeting a productive one and express particular appreciation 

15 to our recorder who has been busy there and I am sure has 

16 captured the remarks throughout the meeting. Thanks also to 

17 Dr. Barnes for his behind-the-scenes administrative support 

18 as well to those at all stages. 

19 And without further ado, we can consider the 

20 meeting adjourned. 

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Certificate of Reporter, Transcriber and Proofreader 

Science Advisory Board - Clean Air Scientific Advisory Committee 

Name of Hearing Jo i n t study Group on Lead - Public Meeting 

Docket No. (If applicable) 

Research Triangle Park, North Carolina 

Place of Hearing 

April 28, 1989 

Date of Hearing ~ 

We, the undersigned, do hereby certify that the foregoing 

pages, numbers 1 through 137 , inclusive, are the 

true, accurate and complete transcript prepared from the 

reporting by ff.I- JfenTf-__S in attendance at 

the above identified hearings, in accordance with applicable 

provisions of the current GSA professional verbatim reporting 

and transcription contract, and have verified the accuracy of .. 

the transcript by (1) comparing the typewritten transcript 

against the reporting or recording accomplished at the hearings 

and (2) comparing the final proofed typewritten transcript 

against the reporting or recording accomplished at the 

hearings. 

Date Name and Signature of Transcriber 

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\y Tune ;<?3 

Date 

ib June '?3 

Date 

R. \JhjJL0m,t r 

Name and Signature of Proofreader 

Heritage Reporting Corporation 

Name and Si 

Heritage Reporting Corporation 

iignature of Reporter 

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