1 ILLINOIS POLLUTION CONTROL BOARD
June 13, 2006
2
IN THE MATTER OF )
3 )
PROPOSED NEW 35 ILL ADM. CODE) R06-25
4 225 CONTROL OF EMISSIONS FROM) (Rulemaking - Air)
LARGE COMBUSTION SOURCES )
5 (MERCURY) )
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TESTIMONY OF DR. DEBORAH RICE
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BEFORE MARIE E. TIPSORD
8 HEARING OFFICER
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The testimony of Dr. Deborah Rice, a
10 witness called in the rulemaking proceeding before the
Illinois Pollution Control Board taken on June 13, 2006,
11 at 9:00 a.m., at the offices of the Environmental
Protection Agency, Springfield, Illinois, before Holly
12 A. Schmid, Notary Public and Certified Shorthand
Reporter, CSR No. 084-98-254587 for the State of
13 Illinois.
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1 A P P E A R A N C E S
2 MEMBERS OF THE ILLINOIS POLLUTION CONTROL BOARD:
Ms. Marie E. Tipsord, Hearing Officer;
3 Dr. G. Tanner Girard, Board Member;
Ms. Andrea S. Moore, Board Member;
4 Mr. Anand Rao, Board Staff;
Mr. Thomas Johnson, Board Staff;
5 Mr. Tim Fox, Board Staff;
Mr. Nicholas Melas, Board Staff;
6 Ms. Alisa Liu, Board Staff.
7 COUNSEL FOR THE ILLINOIS
ENVIRONMENTAL PROTECTION AGENCY:
8 Mr. Charles Matoesian;
Ms. Gina Roccaforte;
9 Mr. John Kim;
Mr. Richard Ayres;
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11 COUNSEL FROM SCHIFF-HARDEN
Ms. Kathleen Bassi;
12 Mr. Stephen Bonebrake;
Mr. Sheldon Zabel;
13 Mr. Jim Ingram, Dynegy, Inc.
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COUNSEL FROM JENNER & BLOCK
15 Mr. Bill Forcade;
Ms. Katherine Rahill.
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COUNSEL FROM McGUIRE-WOODS:
17 Mr. James Harrington;
Mr. David Rieser;
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COUNSEL FOR
19 Ms. Meleah Geertsma
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1 E X H I B I T S
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3 IDENTIFICATION PG.
4 Exhibit No. 4: 48
5 Exhibit No. 5: 52
6 Exhibit No. 6: 74
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1
2 ready to begin this morning. Good morning. My name is
3 Marie Tipsford. I'm a hearing officer in this
4 proceeding. It's entitled in the matter of Proposed
5 Rule ILL. 35 ADM. Code 225, Control of Emissions from
6 Large Combustion Sources, Mercury. The docket is
7 R06-25.
8 I'm going to introduce the panel again
9 today because, as you can see, we have grown. To my
10 left is Dr. Tanner Girard and to my right is Board
11 Member Andrea Moore, the presiding board members
12 assigned to this matter. At the far end, on my left, is
13 Tom Johnson, board member, and at the far end on my
14 right is Nicholas Melas, also board member. To Andrea
15 Moore's right is Tim Fox, her attorney assistant. To
16 Dr. Girard's left is Anand Rao, and to his left is Alisa
17 Liu from our technical unit. With us again today are
18 Connie Newman and Aaron Conley.
19 This is the second day of hearing, and
20 we will proceed day to day, until the Agency is through,
21 or until Friday June 23, whichever occurs first. We
22 will convene at 9 a.m. each day and proceed, until close
23 to five. Thursday is a board meeting day, so on June
24 15, we will convene at 9 a.m. and recess, until after
Page5
1 lunch at around 10:30 or so.
2 During breaks, I am available to
3 answer any procedural questions. You may also direct
4 procedural questions to Mr. Fox or to Aaron Conley. Any
5 members of the press should speak to Connie Newman.
6 I want to emphasize that the Board and
7 staff cannot discuss the substance of the proposal off
8 the record, nor can we discuss any substantive issue.
9 Substantive issues should be raised during the hearing.
10 If you are not sure whether your issue is a substantive
11 issue, please ask and we can also place your issue on
12 the record.
13 Today we will continue with the
14 Agency's prefiled testimony, and allow anyone who wishes
15 to ask questions of the Agency to do so. The prefiled
16 testimony will be taken as if read and entered as an
17 exhibit. I emphasize again, anyone may ask a question.
18 However, I ask that you raise your hand, wait for me to
19 acknowledge you, step to the microphone, and after I
20 acknowledge you, please state your name and whom you
21 represent before you begin your question.
22 Please speak one at a time. If you're
23 speaking over each other the court reporter will not be
24 able to get your question on the record. Please note,
Page6
1 any question asked by a board member or staff are
2 intended to help build a complete record for the Board's
3 decision and not to express any preconceived notion or
4 bias.
5 At the back of the room are sign-up
6 sheets for the notice and cover sheets, which I covered
7 yesterday, if you have any questions, please see me at a
8 break. Dr. Girard, anything this morning?
9 DR. GIRARD: No, just good morning.
10 We look forward to your testimony and questions today,
11 and let's get to work.
12 MS. MOORE: Same thing.
13 MADAM HEARING OFFICER: Let's begin
14 Mr. Kim.
15 MR. KIM: We have a copy of Dr. Rice's
16 prefiled testimony.
17 MADAM HEARING OFFICER: I have with me
18 Dr. Deborah's Rice's prefiled testimony. I will enter
19 this as an exhibit, if there's no objection.
20 MR. BONEBRAKE: Steven Bonebrake, Your
21 Honor -- I'm used to saying -- we moved the mic to the
22 other table, as the court reporter mentioned she was
23 having a hard time hearing the folks at that table
24 yesterday. She was having an easier time hearing us, so
Page7
1 hopefully, my voice will project well today. No
2 objection. We do, however, reserve questions during
3 cross-examination regarding the qualifications of
4 Dr. Rice.
5 MADAM HEARING OFFICER: So noted.
6 This will be marked as Exhibit 3 and entered. We have
7 Dr. Rice sworn in and just a reminder, Mr. Hornshaw --
8 Dr. Hornshaw, I apologize, and Mr. Ross Was sworn in
9 yesterday. You are still sworn in today. That
10 continues. Go ahead, Mr. Kim.
11 MR. KIM: Continuing on with our
12 testimony, and in the order that we outlined yesterday,
13 we are now moving on to testimony and questions and
14 answers from Dr. Deborah Rice. Following Dr. Rice, we
15 will have Agency employee Jeff Sprague and he will
16 conduct his question and answer session. So we will
17 proceed with Dr. Rice, and I believe she's going to
18 begin with the Dynegy Midwest Generation questions, and
19 I think those are the only questions that were posed,
20 specifically, to her.
21 DR. RICE: Question 1: "Has Dr. Rice
22 been retained by the Agency to provide testimony in this
23 matter?" The answer is yes. "A: When was she first
24 contacted by the Agency concerning this rulemaking
Page8
1 proceeding?" I don't know the exact date, but it was
2 about the first of February of this year.
3 MADAM HEARING OFFICER: Mr. Bonebrake?
4 CROSS-EXAMINATION MR. BONEBRAKE:
5 Q. Good morning, Dr. Rice, a follow-up
6 question. Are you being compensated to testify today?
7 A. Yes.
8 DR. RICE: Question 2: "On page 3 of
9 Dr. Rice's testimony, she refers to cross-sectional and
10 longitudinal studies. A: What are `cross-sectional
11 studies?'" Cross-sectional studies can -- are
12 considered -- they are very often described as a
13 snapshot, and that is that the study is measuring
14 exposure and effect at the same time. "What are
15 `longitudinal studies?'" as part B. A longitudinal study
16 provides the opportunity to follow a cohort or group of
17 people over time, so that exposure can be measured at
18 one point, or sequentially, and effects may be measured
19 at a time that's different from the exposure or, again,
20 sequentially over time.
21 MADAM HEARING OFFICER: Mr. Bonebrake.
22 MR. BONEBRAKE CONTINUES:
23 Q. Dr. Rice, are cross-sectional versus
24 longitudinal studies considered to be more reliable?
Page9
1 A. Generally, longitudinal study -- it's a
2 more powerful -- I don't know if I would use the words
3 "more reliable," but it's a more powerful study design
4 because it allows the opportunity -- for example, we're
5 talking about methylmercury, so let's talk about
6 methylmercury. If we think that it's in utero exposure
7 that's important, we can measure the exposure in utero
8 and not test the children, until much later, and in some
9 cases, years later. Whereas that's not possible with a
10 cross-sectional study. With a cross-sectional study, we
11 go in, for example, and measure the effect. We measure
12 the performance of the children and the body burden of
13 the children at the same time.
14 MADAM HEARING OFFICER: Go ahead, Mr.
15 Bonebrake.
16 MR. BONEBRAKE CONTINUES:
17 Q. Is the Seychelles Islands study a
18 longitudinal study?
19 A. It's a longitudinal study. It's unlike
20 the other two studies. It's not a prospective study,
21 which is kind of another term. Prospective study means
22 that the mothers were actually recruited before the
23 children were born. In the Seychelles Islands study,
24 the mother-infant pairs were not recruited, until after
Page10
1 the babies were already born, so at that time, the
2 investigative team went in and collected hair from the
3 mothers, so it can be argued that the measure of
4 exposure might not have been quite as precise in the
5 Seychelles as it was in the other two studies. No. 3:
6 "What is the pathway for exposure to methylmercury for
7 most persons?" Fish. Four: "What is the pathway for
8 exposure to methylmercury for most Illinois residents?"
9 Fish.
10 MADAM HEARING OFFICER: Mr. Bonebrake?
11 MR. BONEBRAKE CONTINUES:
12 Q. When you say "fish," Dr. Rice, what is the
13 water body source of the fish for the Illinois
14 residents?
15 A. I don't know very much about Illinois --
16 well, I know nothing about Illinois-specific data. I
17 can tell you that in the United States, in general, the
18 vast majority of fish that are eaten are commercially
19 caught fish, so they may be ocean fish or they may be
20 fresh water fish.
21 Q. Do you know what percentage of
22 commercially caught fish are caught in the oceans,
23 versus the fresh water of the United States?
24 A. I don't know the exact figure, but I know
Page11
1 the majority of it will be ocean fish.
2 Q. Thank you.
3 DR. RICE: Number 5: What causes are
4 there for persons', particularly children's, auditory
5 and visual impairment, memory deficits, decreases in IQ,
6 deficits in visuospacial ability and changes in motor
7 function, other than pre- or post-natal exposure to
8 methylmercury?" You know, the answer to that is that
9 there are a myriad of causes or potential causes. There
10 nay be congenital conditions. There may be genetic
11 deficits. There may be specific diseases. There may
12 also be other chemical exposures, including, but not
13 limited to, methylmercury, but I think the important
14 point here is that methylmercury produces a
15 constellation of effects that, to my knowledge, are not
16 produced by any other single cause or any other single
17 exposure. One of the kind of hallmarks I think of
18 methylmercury exposure is that it, not only produces
19 cognitive deficits, but it also can produce motor and
20 sensory deficits that aren't produced, or we don't think
21 about them being produced in quite so robust a way by
22 other neurotoxicants.
23 MADAM HEARING OFFICER: Go ahead, Mr.
24 Bonebrake.
Page12
1 MR. BONEBRAKE CONTINUES:
2 Q. What other chemicals, Dr. Rice, cause the
3 types of effects that are identified in question No. 5?.
4 A. Illicit and licit drugs of various kinds.
5 Lead, certainly. I mean, lead is the poster child for
6 environmental neurotoxic effects. PCB's, dioxins,
7 maybe, although we really don't know as much about
8 dioxins as we like. I think those are the main ones,
9 but lots of drugs, lots of things that mothers take
10 during pregnancy. Smoking during pregnancy, alcohol
11 consumption during pregnancy, marijuana, cocaine,
12 anti-epileptic drugs. There are lots of things that can
13 cause impairment in the fetus.
14 Q. What about DDT, Dr. Rice?
15 A. It wouldn't be DDT, per se. It would be
16 the metabolytic (phonetic) DDT, which is DDE. There
17 have been studies that looked at DDE. I think that the
18 evidence for in utero exposure of DDE producing
19 impairment in the fetus is mixed. My conclusion, from
20 looking at the literature, is that there doesn't seem to
21 be an effect. If there is an effect, the signal is
22 very, very weak. For example, in the Oswego (phonetic)
23 study, there's no effect of DDE, for example.
24 DR. RICE: Six: "On page four of her
Page13
1 testimony, Dr. Rice states that there is no evidence of
2 a threshold below which there are no adverse effects.
3 A: Is it Dr. Rice's opinion that there is no threshold
4 for developmental neurotoxic effects of methylmercury?"
5 And I will just -- this is kind of a compound question,
6 so I will just answer this part. It's really -- I don't
7 have an opinion. It's really unknown whether there is a
8 threshold or not. The scientific data that we have --
9 the scientific evidence that we have doesn't identify a
10 threshold, which, you know, as a scientist, I have to
11 say it's always -- when you have no data for it's not
12 the same thing as saying we know there isn't. The only
13 thing I can say is that, with the data that we have,
14 there is no evidence of a threshold, and that it is not
15 safe --
16 MADAM HEARING OFFICER: Excuse me,
17 Mr. Bonebrake.
18 MR. BONEBRAKE CONTINUES:
19 Q. I'm sorry, Dr. Rice. Are you aware of any
20 agencies, state or federal agencies, that have taken the
21 view that there is a threshold, Dr. Rice?
22 A. Not that there is a threshold. I mean,
23 the EPA has a reference dose, which kind of implies a
24 threshold, but I don't think that -- I left the -- I was
Page14
1 with the Agency, and I left three years ago, and it was
2 not the opinion of me and my colleagues at that time
3 that we thought there was a threshold for methylmercury.
4 That's really call I can say.
5 Q. Do you know if the Illinois Environmental
6 Protection Agency has a specific exposure level for fish
7 advisories in the state of Illinois?
8 A. Only from listening to testimony
9 yesterday.
10 Q. Do you know if the Illinois Environmental
11 Protection Agency considers the fish advisory numbers to
12 be thresholds?
13 A. I have no idea. I can't speak to
14 Illinois-specific issues.
15 CROSS EXAMINATION BY MS. GEERTSMA:
16 Q. Meleah Geertsma, M-E-L-E-A-H,
17 G-E-E-R-T-S-M-A, for the Environmental Law and Policy
18 Center, and I just had follow-up question for Dr. Rice.
19 Dr. Rice --
20 MADAM HEARING OFFICER: Excuse me.
21 Could you move to the microphone because I'm having a
22 hard time hearing you.
23 MS. GEERTSMA CONTINUES:
24 Q. Dr. Rice, is there a difference in
Page15
1 definition of "threshold" in the way a scientist would
2 use it, as opposed to, say, a policy maker who is
3 setting a certain level of concern?
4 A. Yeah, absolutely. I mean, risk assessors
5 and policy people have to do risk management, so they
6 are always looking for a number as the starting point
7 for risk management decisions, and people who are pure
8 scientists in the academic community aren't really --
9 don't really have that burden, and so when I say there's
10 no evidence for a threshold, I'm talking about that as a
11 scientist, and not as a risk assessor, which is no
12 longer my hat.
13 DR. RICE: The second part of that
14 question, "and that it is not safe to eat any fish
15 containing any level of methylmercury, regardless of the
16 frequency of fish consumption." No. That's not my
17 opinion. My opinion -- and this -- actually, this is
18 kind of -- that question was a good segway into this
19 because my opinion is that, although we don't know
20 everything we need to know about the toxicity of
21 methylmercury, my opinion is it's reasonable to advise
22 people to keep their fish consumption so that it's below
23 the EPA reference dose, which allows fish consumption.
24 MR. BONEBRAKE CONTINUES:
Page16
1 Q. Dr. Rice, does that mean that the
2 population that keeps its fish consumption below the
3 U.S. EPA reference dose is safe from appreciable risk
4 from the consumption of methylmercury?
5 A. Well, as I said, we really don't know, and
6 so to say to keep fish consumption -- keep mercury
7 consumption below the reference dose is reasonable is
8 really a risk management decision. Is it without
9 appreciable risk? I would say that that's probably
10 true, but I really don't know. You know, again, it's --
11 proving the negative is impossible.
12 Q. Has U.S. EPA said that consumption at its
13 reference dose level would be free from appreciable
14 risk?
15 A. Yes. That's part of the definition of the
16 reference dose.
17 MS. GEERTSMA CONTINUES:
18 Q. Is appreciable risk a term that is
19 strictly defined in terms of a certain outcome number of
20 outcomes, or again, is that more of a policy
21 determination about what levels of potential risks an
22 advisory body thinks is appropriate?
23 A. I would say that's policy language, rather
24 than science language.
Page17
1 DR. RICE: "What effects would
2 Dr. Rice expect to see in a population" -- we are now on
3 6-B. "What effects would Dr. Rice expect to see in a
4 population consuming fish with methylmercury tissue
5 concentration below 0.05 ppm?" That's a low level of
6 mercury in fish, and again, really, the answer here is
7 the same as my answer to the last question, and that is
8 fish consumption should keep mercury intake below the
9 reference dose. Now, normal common fish intake in the
10 United States would certainly, at .05 ppm, would keep
11 methylmercury intake below the reference dose, but I did
12 a couple of calculations, and I will just give you a
13 couple of examples. For 150-pound person, if they take
14 in 4 ounces of .045 ppm seven days a week, that's under
15 the reference dose, and again, we can't say that that's
16 without any effect, but you know, as a risk management
17 policy decision, that's probably reasonable. On the
18 other hand, a 70-pound person, a child, and that's
19 fairly large child, consuming three ounces seven days a
20 week would be above the reference dose, so there's not a
21 clear-cut answer, you know, "Go ahead and eat everything
22 below .05." Again, you have to multiply frequency times
23 amount of fish you're eating times the amount of mercury
24 in the fish.
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1 MADAM HEARING OFFICER: Mr. Bonebrake.
2 MR. BONEBRAKE CONTINUES:
3 Q. Is U.S. EPA's reference dose linked to
4 chronic exposure, that is, longterm exposure?
5 A. It's part of the definition of the
6 reference dose is that it's a lifetime exposure, so it's
7 an amount that one ought to be able to eat every day
8 without producing appreciable risk.
9 Q. Does that also mean that, on some days,
10 you can exceed that number, and still be below the RfD,
11 so long as other days you don't eat any fish, so
12 therefore, the average is below the RfD?
13 A. I think that, again, this is a risk
14 assessment issue and a risk management issue. I think,
15 for most people, averaging is reasonable, and I think
16 that it's very clear that fish consumption advisories
17 allow averaging because they have advised one meal a
18 week, one meal every two weeks, one meal a month,
19 depending on the state and the fish advisory, but I
20 think there's also recognition that there's a limit to
21 that. You know, there's nobody -- and I don't think
22 there's any state that I know of -- that advises that
23 you can eat one meal a year of something -- you know,
24 that you can take in an entire year's worth of mercury
Page19
1 in one meal, and that would be an okay thing to do, so
2 it's -- yes. Probably most people would think some
3 averaging is all right, but there's a limit on that.
4 Q. Just a related question. There have been
5 incidents of what's referenced to sometimes as
6 poisoning, for instance, I believe in Iraq. From your
7 perspective, Dr. Rice, is there a level at which acute
8 poisoning will occur, that is, a level of exposure to
9 methylmercury?
10 A. Oh, absolutely. The first poisoning
11 episode -- there were two poisoning episodes in Japan
12 and the one in Iraq that you referred to, and by
13 "poisoning" what we mean is gross toxicity, that the
14 people are demonstrably obviously ill, and some of them
15 even die. That's poisoning.
16 Q. At what level does poisoning occur?
17 A. It's really hard to say. From the
18 poisoning episodes in Japan, at first, they didn't know
19 it was producing the effects. They thought it was an
20 infectious agent. Nobody had ever seen methylmercury
21 poisoning before, so it was really months, many months
22 before people understood that it was methylmercury, and
23 so it's really impossible to determine the level of
24 exposure and certainly, the cumulative exposure in that
Page20
1 and that population. In the Iraqi population, people
2 got their sooner because they recognized that there was
3 such a thing as methylmercury poisoning, and there were
4 estimates done on how much people were exposed to, and
5 the body burden at which exposure -- at which poisoning
6 occurred, and poisoning occurs somewhere around 20 ppm
7 in hair, frank poisoning in adults. The level is lower
8 for effects on the fetus.
9 Q. Does the 20 ppm in hair correspond to a
10 level or amount in fish that needs to be consumed to
11 generate that level in hair?
12 A. Well, it would. I mean, one could
13 calculate, but we're not terribly concerned about
14 protecting people from frank poisoning.
15 Q. Have you ever seen any data suggesting
16 that fish in Illinois have mercury concentrations above
17 20 parts per million?
18 A. I haven't seen any data from Illinois at
19 all.
20 Q. Have you seen any data suggesting that
21 the --
22 A. But I would say that we're confusing
23 mercury in fish and mercury in hair.
24 Q. Let me back up, then, if I may, Dr. Rice.
Page21
1 Did you say that you can back calculate an exposure
2 level that would be linked to the 20 parts per million
3 in hair?
4 A. One could, yes.
5 Q. Have you?
6 A. I haven't. I think the World Health
7 Organization did that.
8 Q. Do you know what that calculation resulted
9 in?
10 A. I can't remember, no.
11 MADAM HEARING OFFICER: I think we are
12 ready for 6-C.
13 DR. RICE: "How many meals per week
14 would be required to cause these effects; that is, how
15 much fish would a person have to consume in a week for
16 these effects to occur? Again, you have to multiply the
17 amount of fish times the frequency of consumption, times
18 the amount eaten, so I think I have really kind of
19 covered that. D: "Are these effects consistent with
20 what researchers found in the Seychelles Islands?" The
21 Seychelles Islands report their results to be negative,
22 so this is kind of an odd question, but having said
23 that, we -- that .05 ppm, as far as we know, ought to be
24 okay to eat. If there are effects below that, I would
Page22
1 expect them to be the same kind of effects that have
2 been identified in the epidemiological studies which
3 include the list that we have already talked about.
4 MR. BONEBRAKE CONTINUES:
5 Q. The fish that were consumed by the
6 population at issue in the Seychelles Islands study,
7 those fish, on average, have methylmercury
8 concentrations of about .05 ppm?
9 A. They were actually pretty low. Well, we
10 don't really know what people were consuming, but what
11 the Seychelles Islands folks did was they went back to
12 markets in the Seychelles Islands, and they just bought
13 fish that were commonly available in the markets on the
14 assumption that those were the fish that people were
15 eating. They don't have food diaries or food
16 questionnaires or anything like that. They don't know
17 what those mothers were actually eating, but what they
18 did was they went and got a dozen or so species of fish,
19 and they analyzed the methylmercury in those fish and
20 they were generally fairly low. They were .05 to .1.
21 These are ocean fish I guess -- I guess the folks in the
22 Seychelles are eating fairly low off the food chain,
23 generally, but the Seychelles Islands has a commercial
24 tuna fishing industry, and they have one of their main
Page23
1 economic sources of income is a huge -- huge tuna fish
2 cannery, which is now owned by the Heinz Corporation,
3 and so people do eat some meals of high mercury fish,
4 although it's unclear how often they do that.
5 Q. When you use the term "high mercury fish"
6 what do you mean?
7 A. I'm not sure what I mean. I think of tuna
8 as being relatively high. It depends on what species of
9 tuna you are eating. Tuna can be as low as .1
10 something. It can be .3 something for other species of
11 fish, on average, but it can be -- individual tuna fish
12 can be well over 1 ppm.
13 Q. I think you mentioned that the results
14 from the Seychelles Islands study -- I think you used
15 the word "negative."
16 A. No. What I said was they reported it to
17 be negative. The results aren't, in fact, negative,
18 which I think we are going to talk about later.
19 Q. When you say they reported results as
20 negative, what is your understanding of what the author
21 is reporting?
22 A. We're going to get there.
23 Q. I can reserve, until we get to later
24 questions.
Page24
1 DR. RICE: E: "Where are the
2 Seychelles Islands located? In the Indian Ocean off
3 Africa. This is a population of people that are largely
4 African in their ethnicity. F: "What is the source of
5 fish that Seychelles Islands populace consumes?" I'm
6 not exactly sure what that means, but it would be
7 locally caught ocean fish, so I guess that takes care of
8 both potential questions there. G: "Does Dr. Rice
9 consider the Seychelles Islands study to be well
10 conducted and valid?" I do. H: "Does the National
11 Academy of Science conclude that the Seychelles study
12 was well conducted and valid?" Yeah. The National
13 Academy -- the NRCNAS panel reviewed the mercury
14 literature, including a lot of emphasis and some
15 modeling, actually, of three longitudinal studies from
16 the Seychelles Islands from the Faroe Islands and from
17 New Zealand, and they concluded that all three studies
18 were well conducted and valid studies. Two of those
19 studies reported effects associated with methylmercury
20 exposure and the Seychelles Islands the authors reported
21 no evidence for adverse effect.
22 MS. GEERTSMA CONTINUES:
23 Q. Dr. Rice, when you call a study valid and
24 -- well conducted and valid, between different well
Page25
1 conducted and valid studies, will there be differences
2 in a quality of the data based on how exposures and
3 outcomes are measured by the various team?
4 A. Yes. I mean, to say that they are all
5 well conducted and valid does not necessarily mean that
6 they are equal, you know, that, for example, the biggest
7 study was the Faroe Islands study with well over 900
8 children. In fact, the NRC committee estimated that,
9 given the effect size in the Faroe Islands, the
10 Seychelles Island study had about a 50 percent chance of
11 detecting an effect, even if one was there,
12 statistically detecting an effect, so there were, in
13 addition to the NRC panel, there have been other panels,
14 and I think I served on both of them, reviewing those
15 studies and talking about all of the areas that go into
16 well-conducted and valid, but the conclusion of a
17 scientific community is that all three studies are
18 well-conducted, valid studies.
19 MR. BONEBRAKE CONTINUES:
20 Q. Is it true, Dr. Rice, that some
21 environmental agencies, both, in this country and other
22 countries in the world have relied upon the Seychelles
23 Islands study to develop numbers that are similar to the
24 U.S. EPA RfD --
Page26
1 A. There's a whole list of questions about
2 that. Do you want me to answer this now or when we get
3 there?
4 Q. This particular question, if you wouldn't
5 mind, if you could answer that now.
6 A. Are there other agencies.
7 Q. Are there agencies other than the U.S. EPA
8 that have relied upon the Seychelles Islands study to
9 establish reference does or similar measures?
10 A. There is one Agency that I know of that
11 relies exclusively on the Seychelles. There are other
12 agencies that include it, as did EPA.
13 MADAM HEARING OFFICER: EPA. IEPA?
14 DR. RICE: U.S. EPA. I need to make
15 that distinction.
16 DR. RICE: "According to the" -- this
17 is I. I don't know "I" what.
18 MADAM HEARING OFFICER: Six.
19 DR. RICE: "According to the
20 investigators in the Seychelles study, they evaluated 60
21 primary endpoints through age nine, concluded that their
22 data "do not support the hypothesis that there is a
23 neurodevelopmental risk from prenatal exposure resulting
24 solely on ocean fish consumption." See Myers, et al.
Page27
1 2003, last sentence in the abstract. Is this correct?"
2 Yes. This is, in fact, an accurate quote from their
3 abstract, but the way that it's worded I think is
4 important, and it's a scientific wording, and it gets
5 back to the idea that because their data don't detect an
6 effect doesn't mean that there isn't one there, and so
7 being good scientists, that's the way that they word it.
8 I think it's important to point out, however, a couple
9 of things. One is that, at the same time that the
10 Seychelles Islands investigative team is saying that
11 their study does not support evidence for an effect,
12 they have also done benchmark dose analysis from, both,
13 their 66-month data, and now they have in press
14 benchmark dose analysis from their nine-year data and
15 benchmark dose analysis is -- I guess we are going to
16 talk about that at some point later today, hopefully --
17 is a way of determining a defined effect level, so on
18 the one hand, the investigative team is saying they
19 don't have evidence for an effect. On the other hand,
20 they are doing benchmark dose analysis to determine
21 where that adverse effect level is, so I'm not entirely
22 clear how, at this point, the investigative team feels
23 about it, but I think, in addition to that, it's
24 important to point out that other folks have done
Page28
1 additional analysis from the Seychelles Islands data.
2 One was done by -- one was done as part of the NRC
3 analysis and a subsequent analysis was done by Louise
4 Ryan of Harvard University for the U.S. Environmental
5 Protection Agency, in which she modeled the relationship
6 between IQ at nine years and methylmercury exposure, and
7 she found a decrement that is the same order of
8 magnitude as that in the Faroe Islands.
9 MR. BONEBRAKE CONTINUES:
10 Q. The benchmark studies that you just
11 mentioned, Dr. Rice, are those contained in any
12 published peer-reviewed literature at this point?
13 A. The 66-month data is published. I mean,
14 it's referenced in my review. I can't remember exactly
15 where they published it. The nine-year data is in press
16 in neurotoxicology. It's peer-reviewed. It's in press.
17 Q. Dr. Rice, do you know of other scientists
18 who have looked at the Seychelles Islands study and
19 reached the same conclusion as that stated by the study
20 authors, that is, that there's not a neurodevelopmental
21 risk from prenatal methylmercury exposure resulting
22 solely from ocean fish consumption?
23 A. I'm sorry. Would you repeat the question?
24 Q. Do you know if other scientists have
Page29
1 reached the same conclusion as that reached by the
2 authors of the Seychelles Islands study based upon their
3 independent review of that data?
4 A. I know of no other independent analysis of
5 the data, which would be the only way to draw such a
6 conclusion.
7 DR. RICE: 6-J: "In fact, didn't the
8 children in the Seychelles Islands study who were
9 exposed to the most methylmercury perform better on the
10 test of neurodevelopment than those who were exposed to
11 less? It's kind of unclear. What the Seychelles
12 Islands folks decided to do was to test these kids
13 repeatedly, including when they were young infants, and
14 on. Now their nine-year data have been published and
15 early on they saw -- they did see a positive association
16 between the performance and methylmercury, and by
17 "positive" I mean better on motor performance, but when
18 you take the data as whole, and they have done a lot of
19 nonlinear analysis subsequent to their initial studies
20 where, instead of just looking at a linear relationship,
21 or forcing a linear relationship, they actually try to
22 determine whether the relationship has some waves to it,
23 and when you look at that data as a whole, there's
24 really certainly no overriding evidence that performance
Page30
1 is better as a consequence of methylmercury exposure,
2 and in fact, their non-linear analysis revealed that,
3 for IQ at nine years, once you get passed a certain
4 point, that performance is actually worse.
5 DR. RICE: K: "Did the Seychelles
6 population consume more fish than is typically consumed
7 by Illinois residents?" I don't know they consumed, on
8 average, 12 meals a week.
9 MR. BONEBRAKE CONTINUES:
10 Q. When you use the term "meal," what
11 quantity of fish per consumption, time of consumption,
12 are you talking about, Dr. Rice?
13 A. I don't know that the Seychelles Islands
14 folks actually specified portion size. I have not seen
15 anywhere where they specified that. They may have, but
16 I haven't seen it.
17 Q. Do you know if the methylmercury
18 concentrations in the fish that were being eaten 12
19 times per week were comparable to methylmercury levels
20 in fish in the United States?
21 A. I have testified to that, already, and
22 that is that they went out and collected fish from the
23 market and those are the only data that we have, and in
24 general, the levels were between .05 and .1, but we
Page31
1 actually don't know what the people were eating because
2 they just didn't -- they just don't have those data.
3 Q. Do you know if the study authors,
4 themselves, said that, in the Seychelles Islands, women
5 of childbearing age consumed fish containing similar
6 concentrations of methylmercury to those in the United
7 States?
8 A. I'm sorry. I didn't hear the first part
9 of the question.
10 Q. Do you know if the study authors, with
11 respect to the Seychelles Islands study, determined that
12 women of childbearing age in the Seychelles Islands
13 consumed fish of similar concentrations of methylmercury
14 to those in the United States?
15 A. I don't know.
16 Q. I think you mentioned earlier the number
17 of subjects in question in the Faroe Islands study. Do
18 you know the number of mother-infant pairs that were at
19 issue in the Seychelles Islands study?
20 A. The cohorts started with over 800, but at
21 their nine-year data, they were down to 600 something.
22 I don't have the exact numbers.
23 Q. Do you know when the Seychelles Islands
24 study started?
Page32
1 A. The cohort was put together the late 80's,
2 I think. Well, no, the kids are 16 now, so --
3 Q. Were the children in question tested at
4 various points in time?
5 A. Yes, they were.
6 Q. At what points in time in their childhood,
7 Dr. Rice?
8 A. I don't remember exactly because people
9 have kind of, you know, ignored the early baby data as
10 data came out from older ages. They tested them at 66
11 months. They tested them at nine years, but they also
12 tested them a couple of times, I think, at 29 months. I
13 can't remember, exactly.
14 Q. Does six, 19, 29 and 66 months sound about
15 right to you?
16 A. Yeah. That sounds about right.
17 Q. Do you know if the Seychelles Islands
18 study authors determined that, for each of those study
19 points, there was not a demonstrated adverse effect
20 between methylmercury consumption and health effects?
21 A. That is the conclusion of the study
22 authors, yes.
23 DR. RICE: "Are there other studies
24 showing that the children of mothers who eat fish do
Page33
1 better on tests of neurodevelopment than do the children
2 of mothers who eat less fish?" There are studies that
3 show a relationship between increased fish consumption
4 and better performance, but they are not very well
5 covariant controlled, which I think I won't answer right
6 here. "Dr. Rice" -- so I mean that's kind of my general
7 thing, and this gets into specific studies. "Is
8 Dr. Rice familiar with the results of the study that
9 Dr. Hibbeln of the National Institutes of Health
10 reported based on a cohort of children in the United
11 Kingdom?" I'm aware of his presentations. I've heard
12 them -- I've heard a couple of them. To my knowledge,
13 nothing with his name as an author has been published,
14 and what he has reported has been an association between
15 increased fish intake in women in the United Kingdom --
16 this is part of a large nutritional study ongoing in the
17 United Kingdom -- and better performance of cognitive
18 tests in the kids, and as I say, I have heard a couple
19 Powerpoint presentations. I think the last one I heard
20 was a year ago. At that time, he didn't have any
21 omega-3 -- you know, the hypothesis that fish is good
22 for children's development because of omega-3 fatty acid
23 intake. He didn't have any of those data, and I think
24 more important -- I think there's two issues here. One
Page34
1 is that, to my knowledge, the study is not published, so
2 I can't really speak to it in any reasonable way, but I
3 sat in the audience both times and the study was really
4 pretty severely criticized from the audience. You know,
5 the problem with this study, and all of these studies,
6 that are that the biggest determinant of a child's IQ is
7 the mother's IQ, so that, if you're not controlling from
8 maternal IQ and you're not controlling for the
9 environment of the child, then you are missing the two
10 most important covariance. In the United States,
11 increased fish consumption in women is associated with
12 increased education and increased income, which strongly
13 suggests that it's also going to be associated with
14 increased IQ, so that there's a potential, very serious
15 uncontrolled confounder in these studies. Now, this
16 study of Dr. Hibbeln, if he is, in fact, the first
17 author of what he's doing now, is not published. I
18 haven't even seen it in document form and it's -- so I
19 don't think it's been peer-reviewed. Some of what I
20 just said is going to get shorter because it really
21 applies to all of these. One, "In the UK study, didn't
22 the children of mothers who ate more fish during
23 pregnancy have higher IQ's than the children of mothers
24 who ate less, even though the mothers who ate more fish
Page35
1 were exposed to more methylmercury." I am assuming that
2 we're still talking about the Hibbeln study, and my
3 memory just doesn't go back a whole year in regard to
4 the details of an unpublished study, and No. 2: "Is
5 Dr. Rice familiar with the results of Daniels, et al.,
6 who studied the same group of children in the UK, and
7 found that increasing cord blood mercury levels were not
8 associated with increased cognitive impairment, but that
9 increased prenatal fish consumption was associated with
10 improved cognition?" Yes. I am aware of this study,
11 which is published, and so I can look at it, and the
12 same criticism holds, and that is that there's a very
13 important uncontrolled covariant, and the thing I think
14 is particularly telling about this study is that the
15 better performance was not only associated with
16 increased intake of dark meat fish, which has omega-3's
17 in it, but also white fish, which has practically no
18 omega-3's in it, which really suggested there's
19 uncontrolled cofounding. When they looked at
20 methylmercury -- well, again, this was designed to be a
21 nutrition study and some of this contaminant stuff has
22 just been piggy-backed on it. The way they looked at
23 mercury was they looked in cord tissue, which is not a
24 standard marker for methylmercury exposure, and I don't
Page36
1 know what their relationship would be between mercury
2 levels in cord tissue and any of the markers that we
3 usually look at. Moreover, they divided the kids into
4 turtiles with respect to mercury levels. They just
5 divided them into thirds, rather than actually doing
6 what one would expect if they were really interested in
7 looking at methylmercury, and that is to do some kind of
8 a regression analysis. You know, to actually take the
9 data points from each child and model or look at the
10 relationship between exposure and effect, and they
11 didn't do that, so I don't know how to interpret their
12 negative mercury results.
13 MR. BONEBRAKE CONTINUES:
14 Q. Dr. Rice, you mentioned that the Daniels
15 study was published. What is the significance, from
16 your perspective, of publication of a study such as
17 this?
18 A. Well, the significance for me, in terms of
19 this testimony, was that, unlike the Hibbeln study,
20 which I was trying to recall from a year later, I could
21 actually look at this one, but because it's published,
22 it's published in a peer-reviewed journal.
23 Q. What is the significance of a study being
24 peer-reviewed, Dr. Rice?
Page37
1 A. Well, it's -- well, what it means is that
2 a couple of reviewers have looked at it and vetted it
3 and said that it's worthy of publication, but what we
4 all understand is that the peer review process isn't
5 perfect, so to say that something is peer-reviewed
6 doesn't mean that there's no flaws in it.
7 Q. And did the study authors in the Daniels
8 study, then, conclude that there was not an adverse
9 effect demonstrated from consumption of low levels of
10 methylmercury contained in fish?
11 A. I don't have the study in front of me. I
12 think what they said was that -- I think it was just,
13 basically, a one sentence thing where they said that
14 levels of methylmercury were low and were not associated
15 with effects of performance or something. I can't
16 remember exactly what they said, but I'm not really sure
17 how they -- they just used a non-standard marker, so
18 it's really kind of hard to interpret the results.
19 MADAM HEARING OFFICER: Actually, I
20 have a follow-up. Dr. Rice, then you have reviewed this
21 Daniel study.
22 DR. RICE: Mm-hmm.
23 MADAM HEARING OFFICER: Prior to this
24 testimony?
Page38
1 DR. RICE: Yes.
2 MADAM HEARING OFFICER: Just wanted to
3 be clear on that.
4 MR. BONEBRAKE CONTINUES: So it is
5 correct then, Dr. Rice, that, at least, two of the
6 studies that you have considered, the Seychelles Islands
7 study and the Daniel studies, have found that
8 consumption of fish containing methylmercury, at least,
9 at reasonably low levels is not associated with or
10 linked to adverse effects.
11 A. Well, that's a bit misleading to throw the
12 Daniels study in with the longitudinal studies. There
13 are multiple cross-sectional studies that find an effect
14 of methylmercury, but to answer your answer directly,
15 the Seychelles -- the Seychelles investigators report no
16 effect. Additional analyses say there is a deficit in
17 the Seychelles Islands study. The Daniels study reports
18 no effect related to methylmercury, but the data are
19 hard to interpret.
20 Q. With respect to the comment you just made
21 regarding the Seychelles Islands studies, have the
22 authors of the Seychelles Islands study come forth in a
23 publication and said that the statements they made in
24 their 2003 article were wrong, that is, that, in fact,
Page39
1 there was an association of adverse effect in
2 methylmercury exposure notwithstanding what they said in
3 2003?
4 A. They do have some positive results. They
5 have one positive result on motor performance at nine
6 years, for example. The fact that they have gone
7 through -- as I said before, I don't know how to
8 interpret the fact that they have gone through and done
9 benchmark dose analysis from their data. I haven't seen
10 Gary Myers come out and say that he rescinds the 2003
11 sentence.
12 Q. So that's really my question. As far as
13 you know, the statement in the 2003 article is the
14 public statement of Myers, et al., with respect to the
15 Seychelles Islands study?
16 A. What I'm saying is it's one statement. It
17 is a statement.
18 Q. It's still a valid statement. It's not
19 been rescinded, as you said, Dr. Rice?
20 A. I haven't read anything that it has been.
21 I really don't know.
22 CROSS EXAMINATION BY MR. ZABEL:
23 Q. Just one question for clarification,
24 Doctor. You use the word "non-standard marker. Could
Page40
1 you explain that, please?
2 A. Well, in most of the studies of the
3 relationship between methylmercury and performance,
4 people have looked at maternal hair mercury or they have
5 looked at cord blood mercury. These folks looked at
6 methylmercury in cord tissue, and the methylmercury
7 levels in cord tissue were pretty low, and I guess there
8 are two issued related to that. One is that we don't
9 know how to get from cord tissue back to what we
10 understand as markers of exposure that then can get us
11 back to intake. In other words, how much methylmercury
12 the woman was actually taking in to get to this cord
13 tissue. I mean, we know how to get from blood, cord
14 blood, back to intake, but we don't know how to get from
15 cord tissue back to intake, so that's one issue. The
16 other issue is an analytical issue, and that is that the
17 lower the levels that we're trying to detect, the more
18 error there is going to be in the actual analysis of the
19 methylmercury or other chemical, and the more you can
20 appreciate that, the more noise you have in your
21 analytical measure, the less accurate it's going to be,
22 and that will bias the results. That will bias the
23 results towards the null. In other words, that will
24 decrease the probability or the possibility of finding
Page41
1 an effect, even if there is one, so you don't want to be
2 using a marker for which the levels are very low. I
3 mean, I think -- I don't want to make a whole lot about
4 this Daniel study because I don't think there's a whole
5 lot we can make from it.
6 MADAM HEARING OFFICER: I have a
7 follow-up, and let me just say I'm just a lawyer, so
8 this stuff is really going over my, head to a large
9 extent, but the question asked by Dynegy and Midwest
10 Generation refers to increasing cord blood mercury
11 levels. You just said that they measured cord tissue.
12 DR. RICE: Tissue.
13 MADAM HEARING OFFICER: Levels and not
14 the blood mercury.
15 DR. RICE: Right.
16 MADAM HEARING OFFICER: You indication
17 there's a distinction between those?
18 DR. RICE: Yes, there is.
19 MADAM HEARING OFFICER: Thank you.
20 MR. ZABEL CONTINUES:
21 Q. Maybe it would be helpful if you would
22 explain the data that's necessary to get from cord blood
23 or hair measurements back to intake and that's missing,
24 apparently, in the cord tissue data, or for the cord
Page42
1 tissue data.
2 A. Yeah. Okay. To get from cord blood to
3 intake requires -- well, to get from anything back to
4 intake any marker requires a pharmacokinetic model. We
5 know a lot about the relationship -- we know how to get
6 from -- and EPA has done this and other people have done
7 this. We need to know the body weight of the woman. We
8 need to know the fraction -- we need to know -- the --
9 well, we need to know the fraction of methylmercury
10 that's going to be absorbed. We need to know the
11 fraction of methylmercury that's then going to get into
12 the bloodstream. We need to know the blood volume, and
13 if we know all of those things, then we know how much
14 mercury is actually going to end up in the maternal
15 compartment in maternal blood, and then we have
16 information on the relationship between the amount of
17 mercury in the blood of the mother and the blood of the
18 infant. What we don't know anything about is the
19 relationship between methylmercury and in the blood of
20 the mother or the blood of the infant and how much ends
21 up in umbilical cord. We don't know anything about that
22 relationship, so since we are missing that kind of final
23 piece or series of pieces, we don't know how to get back
24 from that to the intake of the mom.
Page43
1 MR. BONEBRAKE CONTINUES:
2 Q. Do you know if, in connection with the
3 Daniels study, the authors of that study had information
4 about methylmercury hair concentration levels in the
5 study population?
6 A. I don't know if they did or not. They
7 didn't present them.
8 MR. ZABEL CONTINUES:
9 Q. How do you get from the mercury
10 concentration in hair back to the intake? You described
11 blood, I believe.
12 A. Okay. You would assume a particular ratio
13 show of hair to blood. Obviously, hair is an excrescent
14 compartment, and so it's farther away from the fetus
15 than cord blood is, and so you have to make a series of
16 assumptions. The assumption ratio is usually 200 to
17 250, but I think that brings up an important point. For
18 example, in the Faroe Islands study, they had, both,
19 hair and cord blood, and what they found was that cord
20 blood was a better predictor of the performance of the
21 child than was maternal hair and mercury. Whereas, in
22 the Seychelles Island and New Zealand, they only had
23 maternal hair, so then you have -- you are quite right.
24 Then you have to get from hair to blood, and back
Page44
1 through blood, back to the intake of the mother, so
2 there's an additional assumption there, and the
3 Seychelles Islands folks, as I said before, this is an
4 African population. They looked at that ratio of hair
5 to blood in just a very few individuals, and so it's
6 hard to make a lot out of it, but unlike Caucasion
7 population where the ratio seems to be 200 to 250 to
8 one, and you also have to appreciate that that's going
9 to be different from woman to woman, so that's an
10 additional source of variance that's not captured in the
11 analysis. The ratio in the Seychelles Islands was over
12 400, and if that's really true, then the exposure in the
13 Seychelles Islands was lower than we think it was, than
14 we have assumed it was.
15 MR. ZABEL:
16 Q. Just for clarification, the 200 to 250
17 ratio you said was assumed. Is it based on empirical
18 data?
19 A. Yes, it is. It's based on empirical data
20 on I think Caucasions?
21 Q. Coming back to your description on the use
22 of blood, you listed several items that were necessary
23 to make the connection back to intake.
24 A. Right.
Page45
1 Q. Are those all based on empirical data?
2 A. Yes, they are.
3 MR. BONEBRAKE CONTINUES:
4 Q. Do you recall, Dr. Rice, what the average
5 methylmercury hair concentrations were in the Faroe
6 Island study population?
7 A. Hair concentrations? I think they were
8 4.4, or something like that. It's all in my document.
9 I don't necessarily have these things off the top of my
10 head.
11 Q. Is there a hair methylmercury
12 concentration level that corresponds to U.S. EPA's
13 reference dose?
14 A. Yes. It's about one, 1.2, depending on
15 who is doing the dividing.
16 Q. Parts per million.
17 A. Parts per million, I'm sorry.
18 Q. Do you recall what the methylmercury
19 concentration was, on average, in the Seychelles Islands
20 study population?
21 A. I think it was 6.3, and I'm not sure that
22 the averages were expressed the same. They can be means.
23 They can be medians. They can be geometric means, and
24 all of those are going to give you slightly difference
Page46
1 slants, colors of averages, and so I'm not sure that
2 those were presented exactly the same way.
3 Q. So Dr. Rice, if my math is right, the
4 average, or mean methylmercury hair concentration in the
5 Seychelles Islands study population is about five times
6 the methylmercury hair concentration that corresponds to
7 U.S. EPA's reference dose. Is that right?
8 A. The average is, yes, but it's important to
9 understand that the range completely overlaps, but the
10 lowest body burdens for the Faroe Islands are really at
11 the 50 percentile of U.S. women, so while there's no
12 question that, when you take the population as a whole,
13 the Faroe Islands is greater than U.S. women.
14 Nonetheless, there is a fair degree of overlap between
15 the two populations, and that's really relevant to the
16 issue of there not being a threshold for effects.
17 Q. Do you recall, Dr. Rice, if the study
18 population in the Daniels study had methylmercury hair
19 concentrations above one to 1.2 parts per million?
20 A. You know, if they reported hair
21 concentrations I don't recollect them, so I can't speak
22 to that. I was paying attention to their marker of
23 methylmercury exposure. Maybe they had hair, I don't
24 know.
Page47
1 Q. I have a copy of the Daniels study, and I
2 have got multiple copies for the Board and Mr. Kim and
3 Dr. Rice. May have I distribute those?
4 MADAM HEARING OFFICER: Sure. If we
5 run out of copies and someone does need an additional
6 copy, we can get some more made. Mr. Kim, I will give
7 you a second to check this and if there's no objection,
8 we will admit this as Exhibit 4.
9 MR. KIM: No objection.
10 MADAM HEARING OFFICER: Seeing none,
11 we will admit this as Exhibit 4.
12 (Exhibit No. 4 was admitted.)
13 MR. BONEBRAKE CONTINUES:
14 Q. Dr. Rice, do you recognize this article?
15 A. I do.
16 Q. What is it?
17 A. It's "Julie Daniels, et al., Fish Intake
18 During Pregnancy and Early Cognitive Development of
19 Offspring."
20 Q. Is this a copy of the article that we've
21 been discussing?
22 A. It is, yes.
23 Q. The Daniels article. If you could, turn
24 with me to page 400 of this article, third from the
Page48
1 back. You will see there's a paragraph at the upper
2 left starting "Although."
3 A. Mm-hmm.
4 Q. That first sentence reads, "Although
5 total cord mercury levels increased with maternal fish
6 intake, our data did not suggest adverse developmental
7 effects associated with mercury." And below that
8 there's -- probably four or five sentences down there's
9 a sentence that reads, "Mercury concentrations in hair
10 samples taken in the United Kingdom were 1.6 ppm, much
11 lower than concentrations from hair samples from the
12 Faroe Islands (4.3 ppm) where adverse effects of
13 prenatal exposure to methylmercury were clear." Do you
14 see that, Dr. Rice?
15 A. I do.
16 Q. Does that refresh your recollection about
17 the levels of methylmercury in the hair of the study
18 population in the Daniel?
19 A. Well, no, because this isn't the Daniels
20 study population. This references a completely
21 independent report from the United Kingdom that's
22 looking at methylmercury in hair. It's a report,
23 apparently, from England, but that doesn't provide any
24 specific information about hair mercury levels in the
Page49
1 Daniels study. As I said before, the Daniels study is
2 looking at umbilical cord mercury concentrations.
3 Q. Was the study population in the Daniels
4 study comprised of residents of United Kingdom?
5 A. Yes.
6 Q. Do you have any reason to believe that the
7 study population in question in Daniels the average hair
8 methylmercury level differs from the average in the
9 United Kingdom?
10 A. I have no way of evaluating that.
11 DR. HORNSHAW: Could I ask a follow-up
12 question?
13 MADAM HEARING OFFICER: Sure,
14 Dr. Hornshaw.
15 DR. HORNSHAW: I'm not familiar,
16 myself, with the Daniels study. Was that a study of
17 people who admitted to eating fish or is that a study of
18 the general population?
19 DR. RICE: No. It's a general
20 population study. It's a big cohort looking at
21 nutrition, nutrition and health.
22 DR. HORNSHAW: Thank you.
23 MADAM HEARING OFFICER: Anything
24 further? Question No. 7 I believe we're on.
Page50
1 DR. RICE: "Dr. Rice states in her
2 testimony at page four as follows: `In fact, there is
3 evidence from both the Faroe Islands and New Zealand
4 studies that the change in adverse effect in the child
5 as a function of maternal methylmercury level may be
6 greater at lower maternal methylmercury levels than at
7 higher ones. What does this mean?" I wish we had a
8 flip chart. What it means is that the slope of the
9 relationship between exposure and effect is greater at
10 lower body burdens. If I draw in the air, will that
11 mean anything to you? Let's do that on a chart. That
12 will be easier.
13 MADAM HEARING OFFICER: We will have
14 to admit it as an exhibit after you're done for purposes
15 of the record.
16 (At which point in the proceedings, a
17 10 minute break was taken.)
18 MADAM HEARING OFFICER: I think we are
19 ready to go back on the record. Dr. Rice.
20 DR. RICE: All right. We're at 7-A.
21 "What does this mean?" If this is increasing exposure,
22 and this is adverse effect, and this is zero, this is,
23 essentially, no mercury here. What it means is that,
24 when you plot this, that the effect is actually
Page51
1 relatively greater at the low end, so it keeps going up,
2 but the slope here is greater than the slope here, so
3 no, it doesn't mean that, after a certain amount, that
4 there's no longer an effect. What it means is that the
5 effect is actually greater down in here at very low
6 exposures, which of course, the most relevant for
7 focusing on -- and the most relevant for protection of
8 public health. This is what you're really concerned
9 about here.
10 MADAM HEARING OFFICER: For purposes
11 of the record, Dr. Rice was drawing on a chart which
12 will be entered as Exhibit No. 5 in the proceeding.
13 (Exhibit No. 5 was admitted.)
14 MADAM HEARING OFFICER: Mr. Bonebrake.
15 MR. BONEBRAKE CONTINUES:
16 Q. Dr. Rice, the slope that you just drew, is
17 that based on the results of the Faroe Island and New
18 Zealand studies?
19 A. Yes. The Faroe islands study, the shape
20 of the relationship is best fit by a non-linear
21 function. That was published -- I mean, Dr. Ryan found
22 that when she did her analysis for the NRC, but it's
23 also part of a report that was done for EPA by the Faroe
24 Island folks, and then it was published in the
Page52
1 peer-reviewed literature, and it's best fit by a
2 logarithmic function, which means that sometimes called
3 supralinear where the effect is actually greater at
4 lower levels, and talking to Dr. Ryan, that was also
5 true for the New Zealand study, although, to my
6 knowledge, that's not published anywhere.
7 Q. That slope would not fit the Seychelles
8 Islands study results given the reported results of no
9 link between adverse effects and methylmercury. Is that
10 right?
11 A. I don't know. I mean, you would have to
12 actually model those relationships and the Seychelles
13 Islands' team did do some non-linear analysis, and some
14 of their models were fit by something better other than
15 a linear relationship, but I don't know exactly what
16 family of curves they looked at, so I really can't speak
17 to that.
18 DR. RICE: "Does this mean that the
19 greater the exposure the less likely there will be to
20 have adverse effects?" No. C: "Does it mean there is
21 a threshold after which there are no deleterious
22 effects?" No. 8: "In her testimony" --
23 MADAM HEARING OFFICER: Excuse me.
24 Dr. Forcade.
Page53
1 CROSS EXAMINATION BY MR. FORCADE:
2 Q. Bill Forcade with Jenner & Block for
3 Midwest Generation. Dr. Rice, your chart shows exposure
4 on one axis and effect on another axis, and I believe,
5 as I can see from here, that it shows an adverse effect
6 as soon as you leave zero exposure. Is that consistent
7 with the statements you made earlier that there was no
8 identifiable threshold or non-threshold or are you
9 predicting there is, in fact, a negative effect as soon
10 as you leave zero exposure?
11 A. This is not to be taken at absolute terms,
12 but I drew it that way because of my earlier statement
13 that there is no -- there is no evidence for a
14 threshold, which doesn't mean, necessarily, that there
15 isn't one, but as far as we know, within the range of
16 exposures in the studies, in the Faroe Island study and
17 the New Zealand study, there is no evidence for a
18 threshold within those ranges, which would mean that the
19 slope would go back to zero.
20 Q. But you're not changing your original
21 position that you don't know whether there is a
22 threshold?
23 A. What I'm saying is that there's no
24 evidence for one, and that's the best we can do as
Page54
1 scientists.
2 MADAM HEARING OFFICER: Mr. Bonebrake.
3 MR. BONEBRAKE CONTINUES:
4 Q. Isn't it also true that there is no
5 evidence of an effect in a methylmercury exposure level
6 approaching zero? I mean, is there some number small
7 enough where there simply is not a number indicating
8 effect, Dr. Rice?
9 A. There are numbers small enough that
10 nobody's really looked. The next question is about the
11 open study, and I guess we're going to get into that,
12 which is a study in the U.S. where they didn't model the
13 data. They just did linear analysis. They just did a
14 linear regression on the data, and they found an effect,
15 and they found an effect within the range of exposures
16 in this population in Western Massachusetts, and so that
17 not only suggests that there's not a threshold, but that
18 there's not a threshold within the range of -- that
19 there are effects below the EPA reference dose is what
20 that study suggests.
21 Q. My question was, though, that, at some
22 level of methylmercury exposure, some low level there is
23 no evidence of an effect. Is that right, Dr. Rice?
24 A. I'm sorry, I didn't understand the
Page55
1 question. It sounded backwards.
2 Q. At some level approaching zero, there is
3 no evidence of an effect. Is that right?
4 A. What I'm saying is that there's no
5 evidence either way. We have no evidence down there and
6 I'm not sure what you mean by "approaching zero" because
7 everybody is carrying some level of methylmercury, so
8 there is a background level.
9 Q. Just trying to get a clarification
10 because, as Mr. Forcade pointed out, your line starts
11 out "Up from zero."
12 A. That's the best we can do with the data
13 that we have. That's the best assumption we have with
14 the data that we have.
15 MADAM HEARING OFFICER: Question No.
16 8, then.
17 DR. RICE: "In her testimony, Dr. Rice
18 mentions the results of the Oken, al. Is it true that
19 the authors concluded that the children they studied in
20 Massachusetts scored higher in neurodevelopmental tests
21 when their mothers had eaten more fish?" The answer to
22 that is the study found a relationship between better
23 performance on memory in these infants. These are
24 seven-month old infants related to fish, increased fish
Page56
1 consumption, and again, this study is designed -- it's
2 piggy-backed on another nutritional study, so it has the
3 same problem of uncontrolled and potentially very
4 important confounding, and we know, as I said before,
5 that there's a relationship between increased fish
6 consumption in the U.S. and education of the mother and
7 family income. This study also found, however, that
8 there was a negative relationship between increased
9 mercury body burden in the mother as measured by hair,
10 hair level in the mother, and performance of the child,
11 so fish intake goes in one direction. Methylmercury
12 exposure goes in the other direction, and this would not
13 be a confound. I mean, if it's true that being smarter
14 and having a higher income and all of that best
15 predicts -- is predictive of fish consumption in the
16 United States, then, if those confounders, or
17 covariants, were controlled for, the mercury effect
18 ought to be stronger, and what the investigative team
19 concluded was that they recommend that women eat fish,
20 but they recommend that women eat fish low in mercury.
21 A: "Wasn't the authors' recommendation resulting from
22 the study that pregnant women eat more fish?" Yes. Eat
23 fish low in mercury. B: "What was the basis of
24 Dr. Rice's conclusion on page five of her testimony that
Page57
1 the hair mercury levels of the mothers in Western
2 Massachusetts are typical of those in the U.S.?" NHANES
3 data, which we talked about yesterday, and that's a
4 national -- National Nutrition and -- Health and
5 Nutrition Examination Survey, and it's on ongoing survey
6 of people, not just women, but people in the United
7 States of tens of thousands of people that's designed to
8 be representative of the population of the United
9 States, and it is a nutrition health survey, and it's
10 only been relatively recently that a lot of chemical
11 exposures have been added to this survey. Methylmercury
12 was added to the survey in 1999, and so far, data have
13 been published for couplets of years, 1999 and 2000, and
14 then 2001 and 2002, and what the folks in the Oken study
15 found was that about 10 percent of the women in their
16 study had hair levels that would be associated with
17 mercury levels over the reference dose, over the EPA
18 RfD, and depending on how you want to do the analysis
19 from NHANES, somewhere between 10 and 15 or 16 percent
20 of women have methylmercury levels that would be
21 associated with those over the RfD, so that was the
22 basis of my statement that these levels are probably
23 representative of those in the United States.
24 MADAM HEARING OFFICER: Mr. Bonebrake.
Page58
1 MR. BONEBRAKE CONTINUES: And the hair
2 level that's associated with the U.S. EPA RfD I think we
3 talked about earlier is somewhere in the one part per
4 million to 1.2 part per million range. Is that correct?
5 A. That's correct, and they found -- this
6 study reported that 10 percent of the women were over
7 1.2 I believe.
8 Q. And the average methylmercury
9 concentration in the Seychelles Islands study population
10 as we talked about earlier I believe is somewhere around
11 six parts per million?
12 A. I think that's about right, yeah.
13 DR. RICE: C: "Does Dr. Rice have
14 information regarding the relative consumption of
15 freshwater versus ocean fish in Massachusetts?" All of
16 C is not my area of expertise, so I'm going to let some
17 other expert witness answer that question. D: "Is a
18 mother's hair mercury level a normal measurement taken
19 in the delivery room or obstetricians's office?" No,
20 but it's been done in multiple studies, and it's easy
21 enough to do, obviously. E: "Have there been
22 representative samples taken across the U.S. to confirm
23 the statement quoted in 8-B above?" Yeah. I have
24 already answered that. F: "If so, then what are the
Page59
1 results of subsequent studies on those babies: NHANES
2 doesn't address -- they don't go in and look at
3 performance of any kind on infants. I mean, it's not
4 designed to be a neuropsychological study, so there
5 haven't been any studies that followed up NHANES in the
6 United States. It's thousands and thousands of people.
7 9: "Dr. Rice refers to IQ decrements in her testimony.
8 A: What is a benchmark for determining whether IQ has
9 been decreased?" I think there's a little bit of
10 misapprehension about what we're talking about here.
11 We're not talking about some bright line that you cross
12 and then you have an IQ decrement. What I mean by "IQ
13 decrement" is this relationship here. If this is now
14 decreasing IQ, you have to think about this backwards.
15 Then there's a relationship, as exposure increases, IQ
16 decrease and that's what we're talking about,
17 increase-decrease.
18 MADAM HEARING OFFICER: Let me point
19 out that Dr. Rice was, again, pointing to what is
20 Exhibit No. 5.
21 DR. RICE: 9-B: "Is there any
22 disagreement among experts regarding what is IQ" -- I
23 will just answer these sequentially because they are
24 really three different questions. "Regarding what is
Page60
1 IQ?" Now, I mean, they are kind of theoretical
2 arguments in the field about how well IQ loads on some
3 inherent G-factor, but that's not really relevant to
4 what we're talking about. "How it should be measured,"
5 no. There is really no disagreement. There are a
6 number of so-called instruments, that is, IQ tests that
7 can be used. Some of them are age appropriate. You
8 don't use the same thing with a two-year-old that you
9 use with a six-year-old or a 20 year-old, so some of the
10 different instruments are really for different ages, but
11 even for children and adults, there are different tests.
12 They are all highly correlated with each other, and
13 there are tests that are very well accepted as being
14 valid. "How it should be measured and how changes in IQ
15 should be determined?" I think that for the purposes of
16 this testimony and for the Board to understand is that,
17 whatever it is that IQ tests are measuring, which I
18 don't think the theory of that is probably of terrible
19 concern, IQ -- performance on IQ tests is very
20 predictive of a variety of things. The performance on
21 an IQ test is predictive of how much money you're going
22 to make in your life, which is part of the documents
23 that we have submitted. It's predictive of how well you
24 do in school. It's predictive of how far you go in your
Page61
1 education, but I think it's also important to predict --
2 to understand that IQ is predictive of how well you do
3 in society. It's really predictive of your SES status,
4 your social economic status. It's predictive of whether
5 you're living in poverty. It's predictive of whether
6 you're on welfare. It's predictive of out-of-wedlock
7 births, if you're a female. It's predictive of ending
8 up in jail, if you're a male. So performance on an IQ
9 test, whatever it's measuring, is predictive of very
10 important and real, real world consequences.
11 MADAM HEARING OFFICER: Mr. Bonebrake.
12 MR. BONEBRAKE CONTINUES:
13 Q. Dr. Rice, are you aware of any studies
14 regarding trends in IQ in Illinois residents?
15 A. No.
16 Q. How about the same question with regard to
17 the United States.
18 A. IQ tests are re-normed every once in a
19 while because there's a drift, and there's arguments
20 about why that drift is occurring, but I don't think
21 that that's really relevant to what we're talking about
22 here. What we're talking about here is a relatively
23 short point in time and looking at the relationship
24 between IQ and contaminant exposure, methylmercury
Page62
1 exposure.
2 Q. Is it your view, Dr. Rice, that
3 consumption of methylmercury will cause a decrease in
4 IQ?
5 A. Yes.
6 Q. And would you expect, therefore, to see,
7 in a population eating methylmercury, a decrease in IQ?
8 A. On a population level, you really --
9 that's not the way you determine that. I mean, you
10 don't -- if you did an IQ test of everyone in the United
11 States this year, and you did one three years from now,
12 and you saw a decrease in IQ, you really wouldn't know
13 what to attribute that to, and we've all been exposed to
14 methylmercury for quite some time I think, so there's
15 just really no way to test the hypothesis that you're
16 putting out there.
17 Q. My question is are you aware of any
18 studies regarding trends in IQ?
19 A. No. I think you asked if I would expect.
20 I think that was your question.
21 Q. Then my question I will state to you is
22 are you aware of any studies in the United States
23 concerning whether there's trends in IQ's among the
24 citizens of the United states?
Page63
1 MR. KIM: I think she's already
2 answered that.
3 MR. BONEBRAKE CONTINUES:
4 Q. I'm not sure that she has. Was your
5 answer no?
6 A. My answer is that there is a drift in IQ
7 tests, and so they are re-normed periodically and
8 different instruments are re-normed at different times,
9 so that the mean is always 100. Their normed so that
10 they conform to a bell curve, so that the mean is always
11 100. One standard deviation about 68 percent of the
12 population going between 85 and 115. Two standard
13 deviations, which is about 95 percent of the population
14 will go between 70 and 130.
15 Q. Is this drift that you mentioned, is that
16 indicative of a trend?
17 A. Nobody knows what to attribute that to.
18 Most people attribute -- it actually is going up. It
19 actually goes up. It's called a Flynn Effect, and most
20 people attribute it to the fact that people are a lot
21 more literate now. They are a lot better educated, and
22 also, there may be some nutritional factors that come
23 into play, and the fact that people don't now have a lot
24 of diseases and parasites that really prevent them from
Page64
1 reaching their genetic potential, in terms of brain
2 development.
3 Q. So IQ's in the United States are
4 increasing?
5 A. I can't say that. I don't know.
6 Q. Are you aware of any studies regarding IQ
7 trends in Japan?
8 A. No.
9 Q. Is Japan a big fish eating country?
10 A. Yes.
11 Q. Would you expect to see, Dr. Rice, a
12 decrease in Japanese IQ's, in light of their fish
13 consumption?
14 A. Japanese have been eating fish for
15 thousands of years. I really wouldn't know what to say
16 about their methylmercury consumption.
17 Q. Has methylmercury been present in fish for
18 thousands of years?
19 A. I don't know.
20 Q. For hundreds of years?
21 A. I don't have the data to really interpret
22 the question that you're asking.
23 Q. Do you know if methylmercury has been
24 present in fish for hundreds of years?
Page65
1 A. I, personally, am not a fish tissue
2 person, so I don't know.
3 Q. Do you know if there are sources of
4 methylmercury in this world that are not man-made?
5 A. Yes, there are.
6 Q. Do those non-man-made sources lead to
7 methylmercury in fish?
8 A. I would assume that they would because
9 they result -- volcanos and fires, for example, result
10 in emission to air, so my assumption would be that they
11 would contribute to methylmercury in fish eventually,
12 yes.
13 Q. So it would be logical, then, to assume
14 that for thousands of years, people have been eating
15 methylmercury?
16 A. I would assume so, but we have no idea
17 about the relative quantity compared to now, so it just
18 really doesn't get you anywhere.
19 MS. GEERTSMA CONTINUES:
20 Q. Dr. Rice, you just used the phrase
21 "reaching genetic potential." Would you say that the
22 roll of a person practicing public health is not just to
23 prevent severe defects or mental retardation, but also
24 in maximizing the population's full genetic potential?
Page66
1 A. Absolutely. That is the role of public
2 health.
3 DR. RICE: 10: "What is the
4 relationship between mercury measured in a mother or
5 child's hair and the mercury measured in umbilical cord
6 blood?" I think we have already kind of addressed that
7 question. The usual assumption is that it's somewhere
8 between 200 and 250 to one. It may have been different
9 in the Seychelles Islands. We don't have enough data to
10 actually say that with any certainty, but I think that
11 it's really important to understand that using maternal
12 hair mercury as the marker really adds a lot of -- it
13 adds another source of variance because, for any
14 woman-fetal pair, any woman, you know, maternal-infant
15 pair, there's going to be some ratio between her hair
16 mercury and her blood mercury, and then between her
17 blood and her fetus' blood, and we already know that
18 there's a great deal of variance between maternal blood
19 and fetal blood. It can be as little as almost one to
20 one. It can be over three to one, but we don't have the
21 corresponding data for hair, so again, if you're using
22 hair as a marker, you're likely to be mischaracterizing,
23 misclassifying exposure to the fetus on the basis of
24 hair, which would bias the results of the study towards
Page67
1 the null. 11: "On page seven of her testimony, Dr.
2 Rice states that fetal blood has 70 percent more mercury
3 than that of the mother. Does Dr. Rice agree that there
4 is disagreement among toxicologists concerning this
5 relationship between fetal and maternal blood levels?"
6 No. I don't agree with that. B: "Does Dr. Rice agree
7 that this relationship may not be consistent?" I think
8 "consistent" is not a term that would be used by a
9 scientist in this regard. It's variable, and it's
10 variable, probably, for biologic reasons, so that the
11 ratio can be, in fact, over three to one, so that a
12 mother who has that kind of relationship between her and
13 her fetus in terms of blood, she is going to be putting
14 her fetus then at relatively more risk than a woman
15 whose ratio is only 1.1 to 1.7.
16 MR. BONEBRAKE CONTINUES:
17 Q. When you speak of variability, is it also
18 true the variability could go the other way, and a woman
19 could have a relationship with her fetal blood that's
20 lower?
21 A. Yes. 1.7 is the central tendency, so that
22 means that there are some that are higher and some that
23 are lower.
24 DR. RICE: 12: "Did Dr. Rice provide,
Page68
1 both, deposition and trial testimony in the matter of
2 Public Media Center versus Tri-Union Seafoods, LLC, et
3 al, consolidated case Nos. CGC-01-402975 and
4 CGC-04-432394 in the Superior Court of the State of
5 California, City and County of San Francisco, the
6 Tri-Union case?" The answer is yes. A: "What matters
7 did Dr. Rice address in her testimony in the Tri-Union
8 case?" I addressed the health effects of methylmercury.
9 B: "Did Dr. Rice's testimony address whether there was
10 a safe level of methylmercury consumption?" No. I
11 didn't. I derived a maximum allowable dose level, a
12 so-called mattel (phonetic) under Proposition 65, which
13 is not, in any way, designed to represent a safe level.
14 It's actually a level at which there has to be a warning
15 label, so I didn't derive a safe level.
16 MR. BONEBRAKE CONTINUES:
17 Q. Was the warning level at issue there
18 designed to reflect or correspond to a safe level for
19 consumption purposes?
20 A. No.
21 DR. RICE: "What comprises a safe
22 level of fish tissue methylmercury content?" I was
23 asked questions associated with that, yes. "The health
24 impacts of methylmercury exposure?" Yes. "Whether she
Page69
1 authored previous papers concerning the Faroe island
2 study, the impact of PCB exposure in the Faroe Islands
3 methylmercury study, and the appropriateness of federal
4 and state fish advisories." I was asked only about one
5 study that I was a third author on, and I was asked
6 questions about the appropriateness of, specifically,
7 the EPA, FDA fish advisory, and I was also asked
8 questions about state advisories. C: "On or about May
9 11, 2006, did the Court enter or file a decision in the
10 Tri-Union case?" I guess I'm no lawyer, so I don't know
11 what it means to file, so I can't speak to this with any
12 degree of expertise at all.
13 MADAM HEARING OFFICER: Dr. Rice, did
14 the judge issue a decision in the case?
15 DR. RICE: Yes. The judge issued a
16 decision in the case.
17 MR. BONEBRAKE CONTINUES:
18 Q. The testimony you just described that you
19 provided, was that, both, a deposition and at trial?
20 A. I'm sorry?
21 Q. You just described some testimony that you
22 provided.
23 A. Yeah.
24 Q. My understanding from your initial answer
Page70
1 was you provided, both, deposition and trial testimony.
2 A. Yes.
3 Q. So my question was were all those matters
4 addressed in, both, your deposition and trial testimony?
5 A. No. No, they weren't.
6 Q. Who were you testifying on behalf of in
7 this case?
8 A. The State of California.
9 Q. And do you know the name of the attorney,
10 or attorneys, who were representing the other side in
11 the case?
12 A. Mr. Hanelon (phonetic) was the lead
13 attorney, and I don't know the law firm.
14 DR. RICE: C-1: Did the Tri-Union
15 court reject Dr. Rice's testimony concerning
16 methylmercury," and 2: "If so, why"?
17 MR. KIM: Before she answers, we have
18 no problem with the question of did the Tri-Union court
19 reject Dr. Rice's testimony. However, the follow-up
20 question, "If so, why?" again, this was similar to a
21 question to a concern or an objection that we raised
22 yesterday with Mr. Ross and contrary to Mr. Ross'
23 situation, the question was asked of Mr. Ross as to what
24 the Illinois EPA had, and I may not have the exact
Page71
1 wording correct. What we asked the Illinois attorney
2 general's office to pursue in terms of a legal client,
3 and Mr. Ross had made reference to that request and that
4 claim in his testimony. Contrary to this situation,
5 Dr. Rice did not have any hand in authoring the case or
6 the opinion at hand here. She is not an attorney, and
7 she did not make any reference to this case in her
8 testimony, so again, it's the same thing. Any testimony
9 she would give speculating or trying to answer why the
10 court did what she did -- did what it did -- would be,
11 basically, outside the scope of what she would be asked
12 here to testify, and it would be irrelevant in terms of
13 information received by the court.
14 MADAM HEARING OFFICER: Just to be
15 clear for the record, your objection is to C-2.
16 MR. KIM: Yes.
17 MR. BONEBRAKE: If I may respond, the
18 issue, in part, is I believe the Court did address
19 questions pertaining to Dr. Rice's testimony, and I have
20 a copy of the decision. We can talk some more about
21 that. Obviously, Dr. Rice' testimony is fairly complex,
22 technically. Dr. Rice I'm sure would have a view of the
23 Court's findings regarding her testimony, which also, by
24 necessity, would address technical issues, so therefore,
Page72
1 I think we are probably in a situation where the
2 decision deals with kind of a combined set of legal and
3 technical findings by the court. It would seem to be
4 Dr. Rice would be in a position to provide her views on
5 why the court did what it did from a technical
6 perspective, at the very least, and one of the questions
7 I was going to ask Dr. Rice was has she read a copy of
8 the decision.
9 MADAM HEARING OFFICER: Dr. Rice,
10 we'll let you answer C-1, and I'm going to go with
11 Mr. Kim on this. I don't think that Dr. Rice is in a
12 position to explain why the court did something,
13 especially when the court should have been able to
14 explain that itself, and I haven't seen the decision,
15 yet. I think you need to put it in the record, and let
16 the document speak for itself.
17 Q. I can certainly put it in the record. I
18 can have her authenticate it, and maybe we can take some
19 questions from there. I think the questions I might be
20 inclined to ask are of kind of a technical nature, but
21 we can take those on a case-by-case basis.
22 MADAM HEARING OFFICER: Take those on
23 a case-by-case basis.
24 MR. BONEBRAKE: Why don't we get a
Page73
1 copy now for the record. It's over 100 pages, so I have
2 three copies.
3 MADAM HEARING OFFICER: I'm going to
4 mark this and enter this into the record as Exhibit No.
5 6 if there's no objection. We'll mark this as Exhibit
6 No. 6.
7 (Exhibit No. 6 was admitted.)
8 MR. BONEBRAKE: I'm sorry. Was that
9 No. 6?
10 MADAM HEARING OFFICER: Yes. So
11 Dr. Rice, did the Tri-Union court reject your testimony
12 concerning methylmercury?
13 DR. RICE: They rejected California's
14 case. I'm not sure that I can answer, specifically,
15 about my testimony. The issue of the use of the
16 technical information was really a legal argument about
17 the use of the epidemiological studies for Proposition
18 65, and apparently, the court rejected that. There were
19 other issues, as well. I mean, this wasn't the only
20 issue, so I mean I guess that all I can say about it.
21 MR. BONEBRAKE CONTINUES:
22 Q. Did the court determine that you had
23 provided misleading testimony in this decision,
24 Dr. Rice?
Page74
1 MR. KIM: Again --
2 MADAM HEARING OFFICER: Before we go
3 there, first, I think -- has she seen the decision?
4 MR. BONEBRAKE CONTINUES:
5 Q. Dr. Rice, have you seen the decision?
6 A. I have not read the decision.
7 Q. You have not read the decision?
8 A. No.
9 MR. KIM: Has this been formally
10 offered?
11 MADAM HEARING OFFICER: Yes, and I
12 asked if there was any objection.
13 MR. BONEBRAKE: Can you turn with me
14 to page 41 of the decision, Dr. Rice. Do you see, in
15 paragraph 121, Dr. Rice, the statement "Dr. Rice
16 provided misleading testimony of the single exposure to
17 methlymercury of the kind at issues in this case can
18 cause adverse effects in humans."
19 MR. KIM: Again, I'm going to object
20 if he's going to quote passages from the case, which she
21 has just testified she never read, and it's,
22 approximately -- pretty thick, I'm not sure -- 118
23 pages. I really don't see any need to go into
24 questioning her on what the judge was thinking and why
Page75
1 the judge decided what he decided. It's irrelevant.
2 she's never read it. She didn't have a hand in writing
3 it. The document speaks for itself.
4 MR. BONEBRAKE: I guess I would point
5 out to the hearing officer there are various statements
6 in this decision that we believe relate to the
7 credibility of Dr. Rice to provide testimony. I was
8 pointing out I believe there are various statements in
9 this decision that bear on the credibility of Dr. Rice
10 with respect to the testimony that she is offering
11 today. We believe that the decision by the California
12 court is very relevant to the Board's deliberations
13 concerning Dr. Rice's testimony, so we do believe that
14 the decision is relevant.
15 MR. KIM: We did not object to the
16 admission of the document.
17 MADAM HEARING OFFICER: The objection
18 is to questioning her on passages which she has not read
19 and I tend to agree with Mr. Kim. It's also difficult,
20 given the minimal number of copies as, understandably,
21 given the size of it for us to be able to follow along,
22 and do this, and I hesitate to let you read select
23 passages out loud without the opportunity to review it,
24 so I think I'm going to go with Mr. Kim on this one, and
Page76
1 ask that you not ask her directly about the passages
2 from the case.
3 MR. BONEBRAKE CONTINUES:
4 Q. Were you paid to testify in the Tri-Union
5 case, Dr. Rice?
6 A. Yes.
7 Q. By whom?
8 A. The State of California.
9 Q. Have you had any discussions with the
10 State of California regarding the decision which has
11 been marked as Exhibit 6?
12 A. I know that it exists.
13 Q. Have you had any discussions with the
14 state, Dr. Rice, concerning that decision?
15 A. Specifically, concerning this decision?
16 Q. Yes.
17 A. I'm aware of the fact that the State of
18 California is asking the judge to reconsider his opinion
19 on the basis of numerous errors of fact.
20 Q. Has the State filed anything with the
21 court with respect to your understanding that they were
22 seeking reconsideration?
23 A. I believe they have.
24 MR. KIM: As a matter of fact,
Page77
1 probably after the break lunch break, we would be trying
2 to get a clean hard copy of the Motion for
3 Reconsideration just so the Board can see that document,
4 as well.
5 MADAM HEARING OFFICER: Okay.
6 MR. BONEBRAKE CONTINUES: Is it your
7 understanding that a Motion for Reconsideration has been
8 filed?
9 MR. AYRES: It has.
10 MR. BONEBRAKE: Do you know if a
11 response for the Motion for Reconsideration has been
12 filed?
13 MR. KIM: We're not aware at this
14 time. It may be. I don't know.
15 MADAM HEARING OFFICER: I would note
16 that you are free to, in your own testimony, challenge
17 any of Dr. Rice's statements and further elicit
18 information from this when you present your case, but at
19 this time, I think it's more appropriate to move on.
20 MR. BONEBRAKE: Just so it's clear, I
21 may have some questions during the course of the day as
22 we continue to ask questions that relate to some of the
23 technical aspects of the court's decision, so is your
24 ruling that I'm not precluded from asking that type of
Page78
1 question?
2 MADAM HEARING OFFICER: We will rule
3 on those as they come up. Are we ready to move on to
4 question 13, then?
5 DR. RICE: 13: "With respect to the
6 United States Environmental Protection Agency's RfD for
7 methylmercury, is the reference dose measure of
8 methylmercury exposure, e.g., consumed, rather than a
9 measure of the concentration of methylmercury in the
10 body?" Yes. That's true. B: "Is there a benchmark,
11 or deleterious effect level, related to concentrations
12 of methylmercury in the body at which certain impacts
13 might be expected in a portion of the population?" I'm
14 assuming here that "benchmark" refers to the benchmark
15 dose analysis that the NRC committee did and what they
16 did was they estimated -- they started with actually a
17 linear curve here. They started with this relationship
18 and then they estimated for a number of endpoints for
19 the Faroe Islands studies, for the New Zealand study,
20 for the Seychelles Islands study for various ways of
21 combining the data, including integrated analysis of all
22 three studies. A point on the curve that was associated
23 with a doubling of the number of children who would
24 follow into the abnormal range, and it was -- the cutoff
Page79
1 was comparable. I mean, obviously, they are looking at
2 a bunch of different endpoints, but the analogy that was
3 made by some of the members of the panel and the members
4 of the EPA peer-reviewed committee was that it was about
5 comparable to an IQ of 75, so the point that they chose
6 as the starting point for derivation of the reference
7 dose was, instead of about five percent of the
8 population having an IQ below 75, 10 percent of the
9 population would be pushed into that range, so that was
10 the starting point. I mean, I don't know if that's what
11 was meant by this question, but I didn't know else to
12 interpret it.
13 MR. BONEBRAKE CONTINUES:
14 Q. Is that number, 58 parts per billion cord
15 blood?
16 A. Well, it's a little bit -- I don't know.
17 The 58 is kind of out there. What they did was they did
18 lots of different endpoints from all three of the
19 studies, 58 parts per billion corresponds to one of
20 them, corresponds to one endpoint from the Faroe Islands
21 study. They did lots of others. EPA does not consider
22 that its reference dose is based only on that one
23 endpoint. The integrative analysis from all three
24 studies, for example, is 34 parts per billion as a
Page80
1 starting point, so I don't think we can say that 58
2 parts per billion is the number.
3 Q. Didn't the National Research Counsel
4 determine that the Boston Naming Test from the Faroe
5 Islands study should be used for purposes of developing
6 a benchmark and the RfD?
7 MADAM HEARING OFFICER: I didn't get
8 the --
9 MR. BONEBRAKE CONTINUES:
10 Q. The Boston Naming Test.
11 A. The benchmark naming post was done on lots
12 of different endpoints, so the answer to your first
13 question is no. The NRC panel -- and these people are
14 my colleagues. I have known them for many years, so I
15 talked to them after it was all over, and their
16 understanding was that the EPA required there to be a
17 so-called critical study, critical endpoint. In other
18 words, you take all the data and you kind of rashet it
19 down to one endpoint, and they had a lot of discussion
20 about what endpoint that would be and so their
21 recommendation was to use the Boston -- to use the Faroe
22 Islands study and the Boston Naming Test. Now, I was
23 actually at the Agency. I'm an author of the EPA
24 reference dose for methylmercury, and I went to my
Page81
1 health director and I said -- because there was all of
2 this data. I mean, there were all of these benchmark
3 doses for all of these endpoints, and I said, "Does the
4 EPA have to use one study and one endpoint?" And she
5 looked at me and she said, "What you're supposed to do
6 is use common sense," so the reference dose, if you go
7 on Iris, you will see that the reference dose is based
8 on a number of these endpoints. When you go through and
9 do the calculation and then calculate intake, almost all
10 of them actually converge on a reference dose of .1, so
11 in that respect, it doesn't matter, almost, which
12 endpoint you choose from the New Zealand study or the
13 Faroe Islands study or the integrative analysis. You
14 can pretty much choose anything, and it all converges on
15 .1 so it's -- that's reassuring. That's really
16 reassuring that the reference dose isn't based on one
17 spurious finding in one study.
18 MADAM HEARING OFFICER: Is this a
19 follow-up?
20 MS. GEERTSMA: I have a question based
21 on something that was said earlier.
22 MADAM HEARING OFFICER: Let's go ahead
23 and finish with that.
24 MS. GEERTSMA CONTINUES:
Page82
1 Q. In response to Question 11 earlier in the
2 testimony, 11 earlier today about fetal blood having 70
3 percent more mercury than that of the mother, I was
4 wondering, did the benchmark dose analysis that you just
5 described, did that assume a ratio of 1.7 or did it use
6 some other ratio that was known at the time?
7 A. The benchmark dose is based on cord blood.
8 The issue then comes into play when you have to go from
9 cord blood back to the intake by the mother, so is that
10 EPA, when we derived our reference dose, we didn't know
11 what that ratio was, and there's been subsequent
12 sophisticated analysis by Dr. Allen Stearn that -- he's
13 the author of the 1.7. We assumed it was unity. We
14 knew that it wasn't -- we called that out as a data gap
15 at the time, so for the benchmark dose analysis, that
16 ratio was irrelevant because it's cord blood.
17 MR. BONEBRAKE CONTINUES:
18 Q. Has U.S. EPA said in publicly-available
19 documents that its reference dose is based on the Faroe
20 Islands study?
21 A. I'm not sure. I know what's up on Iris
22 now is -- it's considered to be dependent on a number of
23 endpoints. What was up on Iris in the past, I'm not
24 sure. I think it's gone -- but that's historical. I
Page83
1 mean, various people from the EPA have published. I'm
2 not sure what you mean by the EPA, if there's -- I guess
3 you're referring to, specifically, documents that have
4 EPA as the author. I'm not sure. I'm not sure whether
5 they have in the past or not.
6 MADAM HEARING OFFICER: Can I ask you
7 to clarify a term. You've used the "Iris" a couple of
8 times.
9 DR. RICE: Integrated Risk Information
10 System. It's part of EPA's website, and it's a list of
11 chemicals and the toxicity values that can be reference
12 doses, or reference concentrations, which are inhaled
13 concentrations, and there's something called a Cancer
14 Slope Factor and so those are listed with the kind of
15 justification rationale for a whole list of chemicals.
16 MADAM HEARING OFFICER: Thank you.
17 MR. BONEBRAKE CONTINUES:
18 Q. We talked a little about the 58 part per
19 billion standard. Is there in corresponding human hair
20 methylmercury level to 58 parts per billion?
21 A. About 10, 10 or 11 ppm.
22 Q. Ten or 11 ppm? Are you aware of any study
23 in the United States showing methylmercury hair levels
24 above 10 or 11 parts per million?
Page84
1 A. There certainly are people in the United
2 States with hair levels of 10 or 11 ppm, absolutely.
3 You usually see that in people who are subsistence
4 fishers or very high consumer of predatory fish,
5 swordfish, expensive fish very often. Swordfish and
6 tuna -- and what is it? Padigonian tube fish, which is
7 now called sea bass or it was called sea bass before the
8 fishery was fished out by people in the United States
9 buying it, so those levels certainly do exist, but it's
10 important to keep in mind that that 58 ppb is not a safe
11 level. It's a defined adverse effect level, so that you
12 would expect there to be effects lower than that, and I
13 have mentioned several times that there's no effect for
14 a threshold, even below that.
15 Q. All the fish you just mentioned are ocean
16 fish. Is that right, Dr. Rice?
17 A. They are, but certainly, I mean, I live in
18 Maine and I'm not an angler, so those are the fish I
19 think, but you could certainly push your mercury level
20 up pretty quickly eating some predatory freshwater fish,
21 as well.
22 Q. What study, or studies, Dr. Rice, are you
23 referring to when you talk about folks with hair mercury
24 levels above 10 or 11 parts per million based on fish
Page85
1 consumption of the type you just mentioned?
2 A. I think that Jane Hightower has something
3 in publication. What exists, unfortunately, is a lot of
4 data that's not published, data from various states and
5 various groups, so that, I can't point you, and again,
6 my area is not really the correlation between fish
7 intake and body burden, so there are other people who
8 can speak to that better than I.
9 MADAM HEARING OFFICER: Mr. Rieser?
10 CROSS EXAMINATION BY MR. RIESER:
11 Q. Similarly, with respect to your last
12 statement about you push body levels up if consuming
13 freshwater predatory fish. Are there any studies that
14 document that?
15 A. I don't know if there are or not, but
16 there really don't need to be. We understand very well
17 the kinetics of the relationship between intake of
18 methylmercury and what your blood level ends up being.
19 In fact, there are little calculators on the web that
20 allow you to do this and we have a program in Maine
21 where we can punch in the parameters, and the blood
22 level gets spit out, so you don't really need to do a
23 study. We know enough about the kinetics to understand
24 very well if you're taking in methylmercury at so many
Page86
1 ppm, what your blood level is going to end up being.
2 Q. Are the calculators on the web supported
3 by a study?
4 A. They are supported by a whole literature.
5 I mean, as I say, we know the pharmacokinetic of
6 methylmercury and all of that is databased.
7 DR. RICE: Where am I?
8 MADAM HEARING OFFICER: 13-C.
9 DR. RICE: "Has U.S. EPA developed a
10 benchmark or deleterious effect level in the body for
11 methylmercury, and if so, what is the current
12 benchmark?" Again, I'm not sure what that is supposed
13 to mean, but I have explained the benchmark dose
14 analysis, so I don't know if that's good enough.
15 MR. BONEBRAKE: That's fine.
16 DR. RICE: D: "Did U.S. EPA base its
17 calculation of its RfD on a benchmark level of
18 methylmercury in the body, and if so, what benchmark
19 level was used?" I think we have just gone over that.
20 EPA considers its reference dose to be based on a number
21 of endpoints that were derived by the NRC panel, and
22 again, we took that -- defined the effect level, which
23 is a doubling of the number of kids who would be in the
24 abnormal range and divided that by 10, so-called factor
Page87
1 of 10 uncertainty factor, and a lot of that uncertainty
2 factor could actually be considered to be data derived
3 because, just on the basis of kinetics, alone, we know
4 that there's going to be a factor of three or four that
5 you have to put on to protect women who maybe slow
6 excreters of mercury and their fetuses have high levels
7 of mercury and so forth, but again there is no evidence
8 for threshold, so there's really no evidence --
9 everything we know suggests that there still may be
10 effects down to the RfD.
11 MR. BONEBRAKE CONTINUES::
12 Q. Does U.S. EPA view its RfD to be something
13 other than a bright line where above you are going to
14 have effects and below you will not?
15 A. Yes. That's one of the things that EPA --
16 "bright line" is kind of a term that EPA managers throw
17 out fairly regularly, and yes, the RfD is not carved in
18 stone. I mean, you have the data that you have, and you
19 work with it as best you can, and you do the best risk
20 assessment that you can possibly do. I think it's
21 important to understand in this case, however, very
22 often the Agency is confronted with having to derive a
23 reference dose for a chemical where you've got one study
24 and erosions and it may not be all that good of a study
Page88
1 or maybe you have a couple of studies. Maybe the model
2 is not that good. Maybe the endpoints aren't that good.
3 Maybe the data the is s not that good and you end up
4 putting on multiple uncertainty factors, 1,000, 300,
5 1,000, 3,000, and so in those cases, you've got to say
6 that the RfD is not a bright line. There's so much
7 uncertainty associated with it. The methylmercury risk
8 assessment is a goal standard assessment. I mean, we
9 know more about methylmercury than we do just about
10 anything else. We have these big epidemiological
11 studies. We have lots of data, so yes, the reference
12 dose is not a bright line, but this reference dose is
13 pretty good.
14 DR. RICE: "Please explain what is
15 meant by Dr. Rice's statement at page four of her
16 testimony that U.S. EPA's RfD .1 micrograms per kilogram
17 per day is based on either the Faroe Islands study or
18 the integrative analysis of all three studies, and I
19 think we have gone over that at this point. 14: "Is
20 U.S. EPA 's reference dose related to the Boston Naming
21 Test results in the Faroe Islands study, and if so, in
22 what way?" and I think I have already explained that, as
23 well, that the Boston Naming Test was, if we were going
24 to do -- the recommendation of the NRC panel was, if you
Page89
1 were going to do critical study, critical effect, that
2 was the endpoint that they recommended, but there's lots
3 of other data out there. 15 --
4 MR. BONEBRAKE CONTINUES:
5 Q. Just for clarification, then, the 58 parts
6 per billion was related to the Boston Naming Test
7 endpoint from the Faroe Islands study?
8 A. Yes.
9 DR. RICE: 15: "Is there disagreement
10 among experts regarding what the appropriate RfD is for
11 methylmercury and the manner in which it should be
12 calculated?" RfD's, to my knowledge, are only derived
13 by EPA and I don't think -- if there's any disagreement
14 within EPA it's that the reference dose is probably too
15 high, but I really haven't talked to all of the experts,
16 so I guess I really can't answer that question.
17 MR. BONEBRAKE CONTINUES:
18 Q. You said that there's views within U.S.
19 EPA that the reference dose is too high. Hasn't U.S.
20 EPA, as recently as 2005, stated that its reference dose
21 is appropriate, Dr. Rice?
22 A. Yes, and I think that's still their
23 official stand, yes.
24 Q. And do other agencies, or have other
Page90
1 governmental agencies, that is, other than U.S. EPA,
2 published thresholds that are similar to RfD's, even if
3 they don't call them "RfD's"?
4 A. 16 is a whole laundry list of other
5 agencies.
6 Q. I guess the question, then, is, with
7 respect to 15, is there disagreement among experts with
8 respect to RfD's or thresholds that are equivalent to
9 the RfD and the manner in which those kinds of numbers
10 should be generated?
11 A. I'm not sure there's disagreement about
12 the manner in which they should be generated. I think
13 we all want to do the best risk assessment that we can,
14 and there's an understanding of what goes into that.
15 There's no question that other bodies have come up with
16 other numbers, and we're going to kind of go through
17 that.
18 DR. RICE: 16: "Have other federal
19 and state agencies, agencies in other countries and
20 domestic international organizations developed different
21 reference doses or similar values with respect to
22 methylmercury?" The answer to that is yes. "What study
23 did the U.S. Agency for Toxic Substances and Disease
24 Registry use as the basis for its minimal risk level for
Page91
1 methylmercury?" They considered -- they use the
2 Seychelles study is my understanding. That's what's in
3 their current document, and they considered that the
4 highest exposure in the Seychelles study represented a
5 no-effect level for the purposes of their MRL. I think
6 it's and their MRL is 0.3 micrograms per kilogram per
7 day, so it's three times that of the EPA reference dose.
8 MADAM HEARING OFFICER: "MRL" is
9 minimal --
10 DR. RICE: Minimal risk level, and I
11 think it's important to understand that ATSDR's mandate
12 is to go in and determine health effects of contaminated
13 sites, so the reference dose in the MRL are for
14 different purposes, and I'm not sure they can really be
15 considered to be comparable numbers. ATSDR's tasked
16 with the very, very difficult proposition of going into
17 a community where there's a superfun site or some
18 terrible toxic waste dump, and determining and assessing
19 health effects in that community or assessing whether
20 there are risks in that defined community , so it's been
21 called kind of a -- the MRL is a clean-up value, whereas
22 the RfD is a dirty down value. The RfD is something
23 that you don't want to get to. The MRL is something
24 that you have already got, this really contaminated
Page92
1 site, and how clean does it have to be before you're
2 really putting people's health at risk? So it's really
3 kind of different.
4 MR. BONEBRAKE CONTINUES:
5 Q. What is the regulatory or statutory basis
6 for the description you just provided regarding the
7 meaning of the minimal risk level, Dr. Rice?
8 A. I'm just explaining to you what ATSDR's
9 charge is as an agency. They do something quite
10 different, and I guess my analogy is, when EPA, for
11 example, does their Cancer Slope Factor, they consider
12 for the general population that they don't want the
13 cancer risk to be any higher than one in a million
14 people, but when EPA regions go in to a contaminated
15 site and they are talking about cleaning up that site,
16 then the standard changes to one in 100,000, or in some
17 cases, one in 10,000, in recognition that there's only
18 so much clean-up you can do, so they really are not
19 exactly apples and oranges, but they really are
20 different things.
21 Q. So it's your testimony that the MRL, then,
22 from the U.S. Agency for Toxic Substances and Disease
23 Registry is not a health-based standard.
24 A. No. It is a health-based standard. They
Page93
1 consider it a health-based standard.
2 DR. RICE: B: "What study did the
3 World Health Organization rely on to establish its
4 tolerable daily intake threshold?" They relied on the
5 Faroe Islands and the Seychelles study, so they didn't
6 consider the New Zealand study. What is interesting is
7 that the starting point, the hair level that they
8 started at to derive their -- it's a provisional
9 tolerable daily intake, actually -- was the same as the
10 reference dose. It was about 11 ppm in hair which is --
11 we all know what that's comparable to now. How many
12 hours are we into this? EPA applied a factor of 10 as
13 an uncertainty factor, which is not a safety factor.
14 It's an uncertainty factor, from that level. WHO, it's
15 JEXA (phonetic), actually, just applied a smaller
16 uncertainty factor, so I mean, really, the basis for
17 their level, which is higher than the EPA reference
18 dose. It's .23 and .23 micrograms per kilogram per day,
19 so it's about double. The U.S. EPA's reference dose
20 really uses pretty much the same starting point, but
21 they applied non-integer uncertainty factors, and they
22 added them, which is something that EPA just would never
23 do, and I wasn't part of that committee, so I don't know
24 why they did that. "What study did the Dutch
Page94
1 Environmental Protection Agency rely on to establish its
2 tolerable daily intake threshold?"
3 MADAM HEARING OFFICER: I don't think
4 you answered the tolerable data.
5 DR. RICE: It's .23 micrograms per
6 kilogram per day. I couldn't find a Dutch Environmental
7 Protection Agency. They have some agency that sounds
8 kind of like the Environmental Protection Agency. I had
9 on my shelf a document from 1995, and that was before
10 most of the data came out, the modern data came out.
11 There was some data from New Zealand, and data from
12 Iraq, and that's what they used, and they said that, for
13 women of childbearing age that they recommended .08
14 micrograms per kilogram per day, which is lower than the
15 EPA reference dose. If there's publication subsequent
16 to 1995, I couldn't find it, so "What did the U.S. Food
17 and Drug Administration rely on to establish its minimal
18 risk level for mercury?" U.S. EPA, FDA's stand on this
19 is unclear to me. They have a very old number they
20 derived back in the 70's and it's .4 micrograms per
21 kilogram per day that's four times the -- it's based on
22 paresthesias. It's based on overt toxicity in adults in
23 the Minamata poisoning episode. It's based on adults
24 having frank neurological signs of methylmercury
Page95
1 poisoning. However, in 2003, David Atchison, who is the
2 chief -- he's the chief medical officer for the FDA's
3 science division said publicly -- and this is on the
4 record -- that FDA agrees with the EPA reference dose,
5 so I'm not entirely sure, and I don't think they have
6 rescinded that, but they haven't come out with a new
7 number. They are asked by a couple of advisory panels
8 to do a risk assessment. In fact, they were pretty much
9 ordered to, and it's my understanding that they have
10 never done that, so I don't know where FDA stands on
11 this.
12 MR. BONEBRAKE CONTINUES:
13 Q. But as far as you know the last published
14 number was .4 micrograms per kilogram per day?
15 A. Back in the 70's, and more recently, their
16 head of science has said that they buy into the RfD.
17 DR. RICE: "What study did the expert
18 group convened by Toxicological Excellence in Risk
19 Assessment rely on to establish its RfD?" This is
20 private group. I mean, anybody can derive an RfD I
21 guess, and the only thing that I could find on their
22 website was something that IGF Keiser had done, had done
23 a site-specific risk management range -- again, it's not
24 really comparable to a reference dose -- for clean-up of
Page96
1 an Alcoa point comfort location in Texas, so it's a
2 site-specific clean-up level, and that was based on the
3 Seychelles Islands. That was all I could find.
4 MR. BONEBRAKE CONTINUES:
5 Q. You weren't able to find a specific
6 numeric level?
7 A. Yes. They have a range. Their range was
8 .3 to 1.1 micrograms per kilogram per day for clean-up
9 or this Alcoa location.
10 Q. Based upon your research and review,
11 Dr. Rice, then, is it true that none of the agencies or
12 other organizations we just discussed have issued an RfD
13 or comparable number that's more rigorous or stringent
14 than U.S. EPA's?
15 A. I think the number that I quoted from the
16 Netherlands was lower than EPA's number.
17 Q. Excluding that number -- and I think we
18 were uncertain about that number. Excluding that --
19 A. I don't think we are uncertain about the
20 number. It's a 1995 document, and it was really unclear
21 why anybody would be asking me about the Netherlands.
22 That's why I'm not sure that there's a later document.
23 Q. But excluding that, the numbers you were
24 seeing were equal to or higher than U.S. EPA's reference
Page97
1 dose. Is that right, Dr. Rice?
2 A. Yes. I think of the numbers that are
3 designed to be comparable to a reference dose. One is
4 lower. Then there's EPA. Then there's the WHO
5 reference level that's higher that I would say is
6 designed to be comparable to an RfD, and then, depending
7 on how you want to interpret the MRL, that's also
8 higher.
9 MR. KIM: Just for clarification, when
10 Mr. Bonebrake asked the numbers you are seeing -- he's
11 referring to the specific identified organizations and
12 figures that are in Question 16. Is that right?
13 MR. BONEBRAKE: That is correct.
14 DR. RICE: It's the one he asked me
15 about specifically.
16 MR. KIM: I just want to make sure
17 that's the universal.
18 DR. RICE: That's the universal of
19 numbers we are talking about. 18: "At page two of her
20 testimony, Dr. Rice refers to mercury poisoning episodes
21 in Japan and Iraq. Is it true that individual exposures
22 in these two cases and these two instances and some
23 cases exceeded 200,000 micrograms of methylmercury?" I
24 don't know if that's true or not. There's really no way
Page98
1 to know what the exposures were in Japan in Minamata.
2 Maybe this kind of calculation was done -- been done for
3 Iraq. I don't really know. These are poisoning
4 episodes where people actually died, so I just didn't do
5 it because I didn't think that it was particularly
6 relevant.
7 MR. BONEBRAKE CONTINUES:
8 Q. It's not relevant because those are
9 instances of acute poisoning, as opposed to chronic
10 dose?
11 A. No. I wouldn't characterize them as
12 acute. Well, "acute" to a toxicologist means one
13 exposure or maybe two exposures. We talk about acute
14 exposure to animals meaning that you are just giving
15 them one dose. I would characterize the exposures in
16 Iraq as being sub acute, maybe. I mean, they were
17 relatively short term, certainly, compared to lifetime
18 exposures. The exposures in methylmercury in Minimata
19 in Negata went on for years before people really figured
20 it out and people stopped eating some of these fish. I
21 don't know how to -- I guess I wouldn't characterize
22 that exposure as chronic, depending on -- there's policy
23 definitions of these numbers. EPA defines "chronic" as
24 more than a tenth of your life. I don't know. I
Page99
1 wouldn't characterize it as chronic. It's certainly not
2 comparable to eating a little bit of methylmercury your
3 entire life.
4 DR. RICE: 19: "Does Illinois EPA use
5 EPA's RfD in calculating fish advisories?" All of this
6 I am going to let somebody else answer. Somebody else
7 would have a better --
8 MADAM HEARING OFFICER: All of
9 Question 19?
10 MR. KIM: Yeah. I think Dr. Rice is
11 going to defer Question No. 19 and Dr. Hornshaw I
12 believe is the person who handled those. He's right
13 here if you would like us to do this now.
14 DR. RICE: I was actually going down
15 through C.
16 MR. KIM: So 19 A, B and C. So would
17 you like us to do that, just to answer the questions?
18 MR. BONEBRAKE: Who was Dr. Rice
19 referring to? I missed that.
20 MR. KIM: Dr. Hornshaw.
21 MADAM HEARING OFFICER: For purposes
22 of the record, it might work, since there's other
23 subsets that Dr. Rice is and reminding Dr. Hornshaw, you
24 were sworn yesterday and still sworn in.
Page100
1 MR. BONEBRAKE: If I may, I think
2 there are some related questions and questions that have
3 been proposed to Dr. Hornshaw, so if I may reserve some
4 related follow-up because I'm not sure what all those
5 questions are, but they may be a little different than
6 what's being asked here.
7 MADAM HEARING OFFICER: The first
8 question is "What is Illinois -- does Illinois EPA use a
9 U.S. EPA's RfD in calculating fish advisories?"
10 DR. HORNSHAW: The first thing I have
11 to do is correct that because Illinois EPA doesn't do
12 the Fish Contaminant Program, first of all. I need to
13 correct this question. Illinois EPA doesn't issue the
14 fish advisory. It's the Fish Contaminant Monitoring
15 Program issued them, as I said earlier, and the fish
16 contaminant Program does use EPA's reference dose in
17 calculating fish advisories. The most stringent
18 advisory is "Do not eat." We have that for all the
19 contaminants. The most stringent advisory we issue for
20 any of the contaminants is "Do not eat." I don't know
21 if you intended that question to be asked.
22 MR. BONEBRAKE CONTINUES:
23 Q. If I may, I think you mentioned that the
24 FMCP does rely on U.S. EPA's reference dose?
Page101
1 A. Yes.
2 Q. Why was U.S. EPA's reference dose
3 selected?
4 A. Because it was what we did at the time
5 that the National Academy issued its report on mercury
6 reference dose. We figured that was the best
7 appropriate Health Protection Value. "Health Protection
8 Value" is the term of art that's employed by the Great
9 Lakes protocol, and we base all of our advisories on the
10 Great Lakes protocol, so we had to come up with a Health
11 Protection Value, and we thought that the National
12 Academy of Science's acceptance of .0001 milligrams per
13 kilogram per day was the most appropriate Health
14 Protection Value.
15 Q. Can you define for us what is a "Health
16 Protection Value" I think is the phrase you were using?
17 A. Yes. It's a value that has, essentially,
18 the same meaning as U.S. EPA's reference dose and that
19 should be acceptable for daily exposure for lifetime.
20 A: Actually this was asked of Dr. Rice, and I don't
21 know if she wants to try and answer part of it, too.
22 MADAM HEARING OFFICER: The question
23 is "Are you aware of any states with more stringent fish
24 advisories than Illinois?"
Page102
1 DR. RICE: I don't even know what the
2 Illinois fish advisory is.
3 MADAM HEARING OFFICER: Dr. Hornshaw,
4 are you aware of any states --
5 DR. HORNSHAW: It's my understanding
6 that Indiana has more advisories more stringent than
7 ours, but that's based on their choice to combine the
8 effects of PCB's and either chlordane or mercury in fish
9 that have more than one contaminant, which the Fish
10 Contaminant Program has chosen not to do at this time.
11 MR. BONEBRAKE CONTINUES:
12 Q. Dr. Hornshaw, what is the more
13 appropriate -- I mean, what is that more stringent
14 standard in Indiana?
15 A. My understanding -- and I have discussed
16 this with the people at the Department of Health in
17 Indiana -- but I'm still not sure how they exactly they
18 use this. They call it a "bump-up." If the
19 contaminant, if there's more than one contaminant in any
20 fish that's under concern, whichever contaminant would
21 derive the more stringent restriction, that's the basis
22 for the advisory. Then it goes up one level above that
23 for the second contaminant, so for instance, they would
24 advise no more than a meal per week based on PCB
Page103
1 contamination, and there's also mercury contamination
2 found in the fish. Then they would bump it up to one
3 meal a month as the advisory, and we would not do that.
4 Q. I think you mentioned the most stringent
5 standard in Illinois was "Do not eat." When is that
6 standard applicable?
7 A. If you have the Technical Support Document
8 tables in Section 4, Table 4.2 and 4.3 lists those for
9 methylmercury, it's greater than 5.6 currently. The
10 fish Contaminant Program will change that one milligram
11 per kilogram to be consistent with FDA action level when
12 we convene this year to do the advisories for next year.
13 MR. KIM: That's on page 53 of the
14 Technical Support Document.
15 MR. BONEBRAKE CONTINUES:
16 Q. If you wouldn't mind, that change will be
17 up or done.
18 A. It will go from what's in the table now I
19 think it's 5.6 milligrams per kilogram to one milligram
20 per kilogram is the level where we will say, "Do not
21 eat."
22 Q. With respect to the 5.62 standard,
23 Mr. Hornshaw, are you familiar with any data that has
24 been collected by IEPA or that IEPA currently has in its
Page104
1 possession that identifies tissue mercury levels that
2 are --
3 A. There are none. The last I am aware of is
4 1.4.
5 Q. It's 1.4 parts per million?
6 A. Milligrams per kilogram, parts per
7 million.
8 Q. I will have some related follow-up
9 separately for Dr. Hornshaw.
10 DR. HORNSHAW: Less stringent fish
11 advisories? I'm aware that Missouri changed their
12 advisory this past year or last year. They now issued
13 a statewide advisory, but it only tells people or women
14 of childbearing age in children under I think 15 to eat
15 no more than a meal per week of any bass species greater
16 than 12 inches. Where we talk about all predator
17 species and don't give a size range. Similarly, Iowa
18 this year changed their advisory. They had one or two
19 advisories that were based on the FDA action levels on
20 PCB's or mercury and they have since adopted some kind
21 of risk-based approach that we use, and I believe their
22 cutoff less stringent than ours. I think they use .2
23 for one meal per week, all the way up to one meal per
24 week.
Page105
1 Q. The current unlimited fish consumption
2 advisory in Illinois is 0.05 parts per million. Is that
3 correct?
4 A. That's correct.
5 Q. Are you aware of whether other states have
6 issued official advisories with a higher unlimited fish
7 consumption number that is above 0.05?
8 A. I can't answer that now. I know, in the
9 past, there were some states that use different value in
10 the Great Lakes area, but since all the Great Lakes
11 states are using Great Lakes protocol, they are all very
12 similar in our fish advisories. I can't speak for the
13 rest of the country.
14 MADAM HEARING OFFICER: I believe we
15 are back to question D where Dr. Rice is going to take
16 back over.
17 DR. RICE: D: "Has U.S. EPA issued an
18 official advisory?" EPA issued a conjoint official
19 advisory with the Food and Drug Administration. E --
20 MADAM HEARING OFFICER: Excuse me.
21 MR. BONEBRAKE CONTINUES:
22 Q. Dr. Rice, what is that advisory?
23 A. Don't eat swordfish, tile fish, King
24 Mackerel and something else. Shark. And then eat a
Page106
1 variety of fish species. Eat fish containing as much as
2 12 ounces a week of fish that contains low levels of
3 mercury, including light tuna. Albacore tuna has more
4 mercury in it than light tuna, so if you are going to
5 eat Albacore tuna, in a particular week, don't eat more
6 than six ounces. That's my recollection of, more or
7 less, what the advisory says.
8 Q. And you use the term "low levels" in that
9 answer. Do you have an understanding of what "low
10 levels" means in connection with that advisory?
11 A. FDA considers low levels to be what's in
12 light tuna. I mean, they really want to protect tuna,
13 and so it's about .1, and it's a little bit of a moving
14 target because FDA is now back to doing fish tissue
15 analysis. It's .14. It's down to .118, but it's
16 something a little bit over .1.
17 Q. The .1 is .1 parts per million?
18 A. Yes .1 parts per million.
19 DR. RICE: E: "Do the U.S. EPA and
20 the U.S. Food and Drug Administration advise the public
21 that women can safely eat fish with low levels of
22 mercury, including up to 12 ounces of tuna?" I guess I
23 could have looked at this as a cheat sheet. Yes. "Does
24 Dr. Rice agree that state and federal fish advisories
Page107
1 inform the public that certain amounts of fish may be
2 safely consumed, even if they contain methylmercury?"
3 You know, I really haven't read all the state
4 advisories. Again, state fish advisories are not my
5 area. Federal fish advisories I guess referenced to
6 just the one that exists, and so I will just speak to
7 that one, and yes, that is implicit I guess in the
8 advisory that you can consume fish, even if they contain
9 methylmercury.
10 MR. BONEBRAKE CONTINUES:
11 Q. Do you disagree with that advisory,
12 Dr. Rice?
13 A. I disagree with the advisory. I don't
14 disagree with the assertion that fish can be safely
15 eaten even if they contain methylmercury, which I think
16 we went through on another question.
17 Q. Does your home state of Maine have a fish
18 advisory?
19 A. Yes, we do.
20 Q. For methylmercury?
21 A. All of the bodies of water in Maine are
22 under a fish advisory because of methylmercury, but
23 Maine has some of the highest levels of fish in the
24 country because we're on the jetstream downwind of the
Page108
1 power plants.
2 Q. Do you disagree with the fish advisory in
3 Maine for methylmercury?
4 A. Maine. Yeah, Maine subscribes, mostly, to
5 at low levels, to the FDA advisory and my supervisor,
6 Dr. Andrew Smith, and I have had conversations about
7 this because it's not -- it's pretty easy to get above
8 the EPA reference dose with this advisory. EPA also
9 differs from the advisory in that we allow some
10 consumption of fish that contain high levels of
11 methylmercury such as swordfish. I don't disagree with
12 that, particularly for people who aren't pregnant or
13 could be getting pregnant soon. I don't disagree with
14 that part of the advisory at all.
15 Q. Are there portions of the advisory that
16 you do disagree with?
17 A. As I stated, I think that the safest thing
18 to do is to keep intake below the reference dose.
19 Eating 12 ounces -- for a child to eat 12 ounces of
20 light tuna a week, puts that child -- again, depending
21 on weight -- above the reference dose, and since I'm a
22 co-author of the reference dose, I disagree with that
23 aspect of this joint advisory, which was very much a
24 compromise for EPA and FDA who had vastly differing
Page109
1 opinions about the risks that methylmercury in fish
2 poses.
3 MADAM HEARING OFFICER: Mr. Zabel.
4 CROSS EXAMINATION BY MR. ZABEL:
5 Q. As you said, you mentioned that Maine is
6 downstream, downwind of the jetstream of power plants.
7 Is it your opinion that the mercury content in Maine
8 fish is the result of domestic power plant emissions?
9 A. Not solely, not by any means.
10 Q. How much, Doctor?
11 A. I don't know. I don't know.
12 Q. Ten percent?
13 A. I don't know. Senator Collins refers to
14 Maine as the tailpipe of the nation, based on this
15 reality, and obviously, it's not just mercury. She's
16 also refers to other air pollutants, but there's
17 certainly natural sources of methylmercury in Maine, as
18 well.
19 Q. You are downstream of China, as well, in
20 the jetstream, are you not?
21 A. But you're a lot closer.
22 Q. We're a lot smaller, too, in terms of
23 emissions. Is that correct, Doctor?
24 A. I don't know.
Page110
1 Q. If you don't know, how can you make a
2 statement like that? You have no data to support it.
3 Is that correct?
4 MR. KIM: I'm going to object. I
5 don't think she was making a quantitative statement.
6 MR. ZABEL: She was making a
7 majoritive statement and trying to get away with it, and
8 that's what I do not like about these proceedings. I
9 will withdraw the question, Madam Hearing Officer.
10 DR. RICE: I just might say that a
11 child eating six ounces a week of Albacore tuna puts
12 them at 380 percent of the reference dose, which is why
13 I disagree, one of the reasons, and I mean, you can do
14 these calculations. They are easy to do. The
15 multiplication is very straightforward. It's very, very
16 easy for, particularly, a child to get over the
17 reference dose very quickly.
18 MADAM HEARING OFFICER: Mr. Zabel.
19 MR. ZABEL CONTINUES:
20 Q. How many Albacore tuna are there in Maine?
21 A. Freshwater or salt water.
22 Q. In Maine. Maine water bodies.
23 A. Maine water bodies. I'm not a fish
24 person. I'm going to guess and say none.
Page111
1 Q. I will accept the guess then.
2 DR. RICE: Where are we?
3 MADAM HEARING OFFICER: G.
4 DR. RICE: "Is it true that U.S. EPA's
5 RfD addresses the amount of methylmercury that may be
6 consumed every day for an entire life?" Yes. I mean,
7 that's integral to the definition of a reference dose,
8 so presumably, one could eat .1 micrograms per kilogram
9 per day every day, and still not be producing
10 appreciable adverse effect, although I've already sort
11 of testified to the fact that we don't really know that
12 there's no effect below the reference dose. H: "Is it
13 also true that if an individual's average daily
14 consumption of fish over a period of weeks or months is
15 less than the RfD, that individual's consumption is
16 considered by U.S. EPA to be less than the RfD, even if
17 that individual, on certain days during that period,
18 consumes more than the RfD?" I'm not sure that EPA has
19 made a formal statement on this, specifically, relating
20 to methylmercury in fish. It's implicit in the advisory
21 that you can -- that there's some averaging that's
22 reasonable. If you can eat one Albacore tuna fish
23 sandwich and not eat any other fish for the rest of the
24 week and that puts you below the cumulative reference
Page112
1 dose for the week, it's implicit in the advisory that
2 that's allowable, but I want to also say that it's part
3 of EPA guidelines that, for reproductive and
4 developmental effects, that EPA considers that one dose
5 is sufficient to produce an effect. In other words,
6 because of the way the fetus develops, there are
7 critical periods that you may be able to produce an
8 effect, if you give a particular contaminant or drug, on
9 day 20, or during a particular day three months into
10 pregnancy and so to be -- so EPA's position is that,
11 even if the data or exposure over an extended period of
12 time, if you don't really know the mechanism, and you
13 don't really know the critical effect, which we almost
14 never do, or I'm sorry, the critical time period, that
15 it can be assumed, or should be assumed that only one
16 exposure may be enough to produce effect, and of course,
17 that argues against the idea of averaging. I think
18 probably good public health policy is somewhere in the
19 middle of that. You wouldn't want to see a pregnant
20 woman sit down and eat two pounds of fish with three ppm
21 of methylmercury any time during her pregnancy or the
22 months leading up to her pregnancy, but that's not to
23 say is that I would be terribly alarmed over one meal
24 that is slightly above the reference dose, as long as
Page113
1 the woman is paying attention to how much cumulative
2 mercury she's eating. I know that's a really long
3 answer.
4 MR. BONEBRAKE CONTINUES:
5 Q. Are you familiar with the federal CAMR?
6 A. Not terribly, no.
7 Q. Are you familiar with U.S. EPA's
8 reconsideration of the federal CAMR?
9 A. No.
10 Q. So you haven't read any of the documents
11 associated with U.S. EPA's reconsideration?
12 A. You know, I have tried to read some of the
13 documents, but some of that is so outside my field
14 because it's really all about deposition and power
15 plants, and I just cannot speak to it with any expertise
16 or insight, whatsoever.
17 Q. Do you recall any discussion in the
18 documents that you did see indications that U.S. EPA
19 simply did not have data to support the view that a one
20 dose of methylmercury during pregnancy would cause
21 adverse effects?
22 A. I don't recollect seeing that. I'm not
23 surprised that there's no data because there's not --
24 there are just no studies where a woman goes from zero
Page114
1 mercury, one big spike of mercury, and then zero
2 mercury. We all have a background of mercury, and
3 again, it's the idea that just because we don't have
4 data to support that -- my argument is on theoretical --
5 my argument is on what we know about development of the
6 fetus and so it's not -- it's not a data-based argument,
7 so it's not at all surprising that a sentence like that
8 would be in there.
9 Q. So your view is an extrapolation from the
10 existing data, rather than a conclusion drawn directly
11 from the data, itself,
12 A. It's not drawn from the data, no it's not.
13 MADAM HEARING OFFICER: Dr. Rice, it
14 is right nearly 12 o'clock. That ends Question No. 19
15 which puts us halfway through the numbers of questions.
16 That means that why don't we go ahead and take a lunch
17 break. Try to get back as close to one as possible.
18 (At which point the hearing was
19 adjourned for lunch.)
20 Q. MADAM HEARING OFFICER: I believe we are
21 ready to start with question 20 of Dr. Rice.
22 DR. RICE: 20: "With respect to the
23 PCB's, it appears from Dr. Rice's testimony Appendix A
24 to the TSD, and the references thereto that Dr. Rice has
Page115
1 studied the developmental neurotoxicant effects of PCB's
2 in infant monkeys exposed through breast milk. Is that
3 correct?" Not entirely. What we did was a study in
4 which infant monkeys were actually fed -- infant monkeys
5 -- a formula of which there is such a thing, and to
6 which we added a mixture of PCB's that was designed to
7 be representative of the PCB mixture in Canadian milk.
8 PCB's are a mixture. There's a possible 209 different
9 kinds of different PCB's, depending on how many chlorine
10 atoms there are, and where they are on the ring, and
11 they may have different toxicities, so our study was
12 designed to look at the mixtures that is found in the
13 breast milk of Canadians, which is really the same as
14 that found in the breast milk of Americans. "Does
15 Dr. Rice agree that PCB's are an established
16 neurotoxic?" It is a neurotoxicant, indeed. It's a
17 developmental neurotoxicant. B: "Has the EPA issued an
18 RfD for PCB's?" They have issued two for two different
19 commercial mixtures. "If so" -- this is B-I -- "If so,
20 what is that RfD?" As I said, they have two for
21 commercial mixtures. They are both based on data from
22 monkeys, not from data in humans. One is a so-called
23 aerochlor (phonetic) 1254, and this is a mixture in
24 which it has a relatively high component of chlorine
Page116
1 atoms in the mix. It's not representative of the
2 mixture in humans, but it's a better approximation than
3 1016, which is the other one. The reference dose is two
4 times 10 to the minus fifth milligrams per kilograms per
5 day, and that's based on suppression of immune function
6 in adult Reyes monkeys. The other reference dose for
7 PCB's that the EPA has is for aerochlor 1016. That's
8 based on developmental effects in Reyes monkeys and
9 that's five times 10 to the minus fifth milligrams per
10 kilogram per day. Two: "Has Illinois EPA issued fish
11 advisories for PCB's?" Somebody else will have to
12 address that.
13 MR. KIM: I believe Dr. Hornshaw is
14 not here right now.
15 MR. BONEBRAKE: We can address that
16 question later.
17 DR. RICE: C: "How did the level of
18 PCB exposure in the Faroe Islands compare to U.S. EPA's
19 RfD for PCB's?" There's no way of knowing that because
20 what we have in the Faroe Islands is levels in cord
21 tissue. We don't have intake. We don't have any
22 measures of intake at all, so it's impossible to say.
23 D: "How did the level of PCB exposure in the Faroe
24 Islands compare to the level that produced effects in
Page117
1 the infant monkeys that Dr. Rice experimented with?"
2 Again, really the same as C, we have an external dose,
3 but we don't know anything about the actual exposure to
4 PCB's in the Faroe Islands, so it's really not possible
5 to answer that question.
6 MR. BONEBRAKE CONTINUES: A follow-up
7 question. Do you recall, Dr. Rice, if the court in the
8 Tri-Union Seafoods case addressed the question of
9 whether the PCB's found in the Faroe Islands population
10 exceeded the reference dose for PCB's?"
11 MR. KIM: By way of clarification,
12 when you say "addressed" are you referring to the
13 opinion that was handed out as an exhibit earlier today?
14 MR. BONEBRAKE: The opinion or
15 otherwise.
16 MR. KIM: I'm assuming the same ruling
17 on the opinion itself stands.
18 MADAM HEARING OFFICER: Dr. Rice has
19 already indicated she hasn't read the opinion, so she
20 can't really comment. Could you rephrase the question,
21 perhaps?
22 MR. BONEBRAKE: I think the question
23 includes, but is not limited to the opinion, so if she
24 otherwise knows if the court addressed the question of
Page118
1 whether the PCB level Dr. Rice knows whether the PCB
2 level present in the Faroe Islands exceeded the RfD for
3 PCB's.
4 DR. RICE: We certainly talked a lot
5 about PCB exposure in the Faroe Islands in that trial.
6 I don't remember whether we talked about how it related
7 to the reference dose. I really don't recall, but as I
8 say, we don't know the intake in the Faroe Islands, and
9 so I can't really make any substantive statement whether
10 it exceeded the reference dose or not.
11 MR. BONEBRAKE CONTINUES:
12 Q. Well, can we turn to page 34, paragraph
13 105 of Exhibit 6, which is a copy of the opinion?
14 MR. KIM: Again, if we're --
15 MADAM HEARING OFFICER: Let's listen to
16 the question before you object.
17 MR. KIM: Sure. Page 34.
18 MR. BONEBRAKE CONTINUES:
19 Q. Page 34, paragraph 105. The question will
20 relate to the first sentence in that paragraph, which
21 reads, "The average daily exposure to PCB's among
22 Faroe's women exceeds the United States reference dose
23 for PCB by 172 times, and the average daily exposure to
24 methylmercury exceeds the RfD for methylmercury by four
Page119
1 times." Dr. Rice, do you believe that to be an
2 incorrect statement by the court?
3 MR. KIM: Again, before we go any
4 further, I'm not sure of the abbreviations the court is
5 using. I note after that statement, there is --
6 DR. RICE: This is testimony for Jay
7 Murray for the fishing industry.
8 MR. KIM: This is testimony of a
9 different witness. I don't know if Dr. Rice was present
10 during that testimony, but regardless --
11 DR. RICE: I wasn't.
12 MR. KIM: This was a statement by the
13 Court restating other testimony that was provided during
14 the course of the hearing or the trial, presumably, so
15 again, the statement speaks for itself to the extent
16 that some recitation or citation is going to be made in
17 here.
18 MADAM HEARING OFFICER: His question
19 is does she agree or disagree with that statement, and
20 given these parameters, whether or not she disagrees,
21 or agrees, she can make that qualification.
22 DR. RICE: In relation to PCB's again,
23 I don't know how Dr. Murray came up with this
24 calculation. He surely must have somehow tried to back
Page120
1 extrapolate from body burden to intake, and to my
2 knowledge, there hasn't been a good PK model. There
3 hasn't been good pharmacokinetic modeling for PCB's to
4 get in humans or any other species to get from the body
5 burden back to intake, so I have no way of knowing how
6 he came up with 172. I didn't hear his testimony. I
7 didn't read -- I just don't know.
8 MADAM HEARING OFFICER: So you can't
9 really express an opinion.
10 DR. RICE: My opinion is that we
11 really don't know. My opinion is that the appropriate
12 pharmacokinetic modeling has not been done, so we have
13 no way of knowing.
14 DR. RICE: Is it -- this is E: "Is it
15 true that mothers in the Faroe Islands mercury study had
16 PCB concentrations in their bodies that were among the
17 highest body burden concentrations in the world?" The
18 PCB body burdens in the Faroe Islands are high compared
19 to the U.S. population. I mean, the world, most of the
20 population in the world haven't been assessed, but
21 there's no question that the PCB body burdens, the
22 average PCB body burdens, in the Faroe Islands are
23 higher than those in the U.S. or in Europe, but again, I
24 think it's important to point out that the distributions
Page121
1 overlap and they overlap fairly substantially.
2 MR. BONEBRAKE CONTINUES:
3 Q. What do you mean by the "distributions
4 overlap," Dr. Rice?
5 A. I mean that some of the folks in the Faroe
6 Islands had body burdens and PCB's that were the same as
7 some of the people in the United States.
8 Q. Some had PCB concentrations much higher?
9 A. I haven't seen -- I don't know the whole
10 distribution. Certainly, the average is much higher. I
11 think it's probably reasonable to assume that there were
12 a lot of people in the Faroe Islands that had higher
13 body burdens than most of the people in the United
14 States.
15 DR. RICE: "Is it correct that when
16 the Faroe Islands study is adjusted for PCB exposure,
17 the investigators in that study concluded that any
18 correlation between methylmercury and performance on the
19 Boston Naming Test was not significant?" No. I don't
20 think the Faroe Islands study team concluded that.
21 There were -- the NAS committee addressed this
22 co-exposure to PCB's in the Faroe Islands in great deal
23 because it's an important issue. You know,
24 methylmercury is a neurotoxicant. PCB's are
Page122
1 neurotoxicant. They are both developmentally
2 neurotoxic, so it's an issue that really needs to be
3 addressed, and they did this in a couple of ways. They
4 head the Faroe Islands investigators -- or they did --
5 control -- look at the benchmark doses with and without
6 control for PCB's. They also divided the cohort for
7 which there were PCB data available by turtiles. In
8 other words, they divided them into thirds, lowest,
9 middle and high, and looked to see if there was any
10 difference, systemic difference, in the effects of
11 methylmercury, depending on whether the kids had low or
12 high PCB body burdens and there was no evidence for any
13 kind of systemic change. The Faroe Islands
14 investigators also looked to see whether there was a
15 statistical interaction between methylmercury and PCB's
16 in their cohort and they didn't find one. The
17 conclusion of the NRC panel was that the effects of
18 methylmercury and PCB's appeared to be independent of
19 each other, and I might say -- and this adds I think
20 even more assurance in this regard -- the Faroe Islands
21 folks chose not to look at their cohort when they were
22 babies. They didn't look at them, until they were seven
23 years old, and then they also looked at them again at 14
24 years of age. The 14-year data are now published and
Page123
1 what they found at 14 years was that there was still
2 effects on Boston Naming. There were still effects on
3 attention, measure of attention, which is reaction time
4 on a vigilant task and there were still effects on motor
5 performance, which is three of the endpoints that were
6 significant at seven years. When they did their 14
7 years analysis, there was absolutely no evidence for
8 effect of PCB's, so I think that adds further
9 reassurance that there's nothing really wonky about the
10 Faroe Islands study or the Faroe Islands data or
11 interpretation of that study.
12 MR. BONEBRAKE CONTINUES:
13 Q. When was that additional analysis you just
14 referred to?
15 A. It's online in Environmental Health
16 Perspective. No. It's online in Neurotoxicology and
17 Teratology.
18 Q. When was that work performed, Dr. Rice?
19 A. Well, I mean, the guys are 16 and 17 now,
20 so the 14-year data was collected several years ago and
21 there was actually one paper already published on the
22 14-year data reporting deficits in sensory regarding
23 sensory effects that were -- had been found at seven
24 years that were still found at 14 years, but this is now
Page124
1 further analysis on their cognitive endpoints.
2 DR. RICE: "Did you co-author a paper
3 in 2003 that found a correlation in the Faroe Islands
4 study between the prenatal PCB exposure and poor
5 performance on the Boston Naming Test?" I think what we
6 stated in that paper was that we did author a paper. We
7 state that the results are not significant after control
8 for methylmercury. The PCB effects are not significant
9 after control for methylmercury exposure. When we were
10 talking about the 2001 paper -- they actually published
11 two papers on their seven-year data. One was on the
12 effects of methylmercury controlling for PCB's, and
13 then, because there was so much concern in the community
14 about the co-exposure to PCB's, they also published a
15 paper in 2001 on the effects of PCB's and what they
16 found was that, when they control for methylmercury,
17 there was no effect of PCB's on the Boston Naming Test,
18 and that there was no evidence -- in their 1997 paper,
19 the authors reported that there was no evidence for an
20 interaction between methylmercury and PCB's, and that's
21 what we reported in our paper.
22 Q. So with respect to your 2003 report and
23 you were a co-author of that report. Is that right?
24 A. Yes.
Page125
1 Q. And that report did you say found a
2 correlation or no correlation? I wasn't clear from your
3 answer.
4 A. No correlation. There was no correlation
5 between methylmercury and PCB's. That's what the
6 authors reported. I mean, that wasn't -- I mean, we
7 didn't have the raw data. In their 2001 paper, the
8 investigators said that, after control for
9 methylmercury, there was no effect of PCB's on the
10 Boston Naming Test.
11 Q. Can we turn to page 41, paragraph 120 of
12 Exhibit 6, which is again, the order -- call it the
13 decision -- in the Tri-Union Seafoods case, and I was
14 interested in the second sentence in that paragraph.
15 MADAM HEARING OFFICER: Could you give
16 the page number again?
17 MR. BONEBRAKE: Yeah. It's actually
18 top of page 41, and it's in paragraph 120, and it's the
19 second sentence in that paragraph, and it reads, "Dr.
20 Rice's paper reports that a number of endpoints in the
21 Faroe Islands study, including the Boston Naming Test,
22 were negatively associated with methylmercury, until the
23 authors controlled for the effects of PCB's." Do you
24 agree with that description of your paper, Dr. Rice?
Page126
1 A. No.
2 Q. So you think the court got it wrong?
3 A. Yes.
4 Q. Is that -- the paper that's referenced
5 there, has it been published?
6 A. The Chaset, et al., paper.
7 Q. The 2003 report?
8 A. Yes.
9 Q. So as far as you now, Dr. Rice, that is
10 available publicly?
11 A. Yes. It is available publicly.
12 MADAM HEARING OFFICER: Could I ask
13 where that was published?
14 DR. RICE: Environmental Health
15 Perspective, so it's actually available free online.
16 DR. RICE: H: "Is it possible that
17 PCB's could have had an influence on the results of the
18 Faroe Islands study by producing or contributing to
19 environmental toxicity?" Yes. It's possible that
20 that's true. You know, these statistical methods aren't
21 perfect and just because the effects weren't
22 statistically significant doesn't necessarily mean that
23 there wasn't an effect. The NRC panel really did the
24 best job they could at looking at the co-exposure of
Page127
1 methylmercury and PCB's. Their conclusion was that the
2 effects, if there are effects, they are independent, so
3 even if there is a PCB effect in the Faroe Islands, it's
4 independent of that of methylmercury, and that's not my
5 opinion. That's the NRC's opinion and I really have no
6 further light to shed on that.
7 MR. BONEBRAKE CONTINUES:
8 Q. When you say "independent," what,
9 specifically, do you mean, Dr. Rice?
10 A. I'm trying to think of how to explain this
11 without talking about it statistically. If you look at
12 the relationship between methylmercury body burden and
13 performance on any measure, you will get some
14 relationship. You can do the same thing for PCB's. It
15 happens that the correlation between children, between
16 methylmercury body burden and PCB body burden was low
17 enough that those effects could be teased out. They
18 could be separated from each other. Does that make
19 sense?
20 MADAM HEARING OFFICER: It's your
21 question.
22 MR. BONEBRAKE CONTINUES: That's fine
23 if, that's your answer. We can let it stand.
24 DR. RICE: 21? Is that where we are?
Page128
1 "Isn't it true that women and children studied in the
2 Faroe Islands study ate almost exclusively whale meat
3 and/or whale blubber?" I'm assuming that only includes
4 meat, and not vegetables. I don't know, but anyway,
5 folks in the Faroe Islands also ate a significant amount
6 of fish. It's an island. It's a group of islands, in
7 fact, in the North Atlantic, so in addition to eating
8 whale, they also ate fish. Now, some women in the
9 population ate whale. Not everybody ate whale. Some
10 women ate whale blubber, and it's important to
11 understand that the whale meat contains methylmercury
12 and the whale blubber contains PCB's, and so some women
13 liked the meat, and not the blubber, and vice versa,
14 which is one of the things that allowed the effects of
15 PCB's or potential effects of PCB's and those of
16 methylmercury to be discriminated. I mean, if everybody
17 ate meat and blubber, then you couldn't tell the
18 difference. "How much whale meat or whale blubber does
19 the average American eat?" I'm going to take a guess
20 here and say not much. "How much whale meat or whale
21 blubber does the average Illinois resident eat?" 22:
22 "Is it Dr. Rice's opinion that people should not eat
23 fish because of potential for exposure to
24 methylmercury?" I think we have covered that before by
Page129
1 saying that we can't be sure that anything is absolutely
2 safe, but I certainly wouldn't recommend that people
3 don't eat fish or never eat fish. I eat fish. Last
4 night for dinner I had crab cakes and salmon, which are
5 both low in methylmercury, I might point out, so I
6 wouldn't say that. 23: "How do average mercury levels
7 in Illinois fish that are typically consumed compare to
8 average mercury levels of" -- okay. This is not any
9 question. This is an Illinois person question.
10 MR. KIM: Dr. Hornshaw is here now, so
11 he can answer this, if you like.
12 MR. BONEBRAKE: My preference would be
13 to cover it when Mr. Hornshaw is presenting later.
14 DR. RICE: 24 falls into the same
15 category. So go on to 25?
16 MR. BONEBRAKE: Yeah.
17 DR. RICE: "At page six of her
18 testimony, Mr. Rice refers to a study involving
19 dentists. Do dentists have higher or lower incident of
20 heart disease than other American men exposed to
21 mercury?" You know I was unaware whether there was any
22 literature on this at all because I didn't know why
23 anybody would do this, so I went to Medline, which is a
24 database for looking up publications, and I only found
Page130
1 one study from Japan that even addressed the issue, and
2 they actually found a lower incidence in dentists. Now,
3 I don't know why that would be true and it's only one
4 paper, so I don't think any weight could be put on it at
5 all.
6 CROSS EXAMINATION BY MS. BASSI: Well,
7 why in the study where you were talking about in your
8 testimony, apparently, at page six which I forget right
9 now, but you were talking about excluding dentists. Why
10 would dentists have been excluded from the study
11 participants?
12 A. I'm --
13 Q. For cardiovascular effects.
14 A. I'm assuming that's why this question was
15 asked. Because dentists are exposed to mercury vapor,
16 which is inorganic mercury. It's not methylmercury. A
17 different form of mercury in the body, and so it may
18 have very different effects than methylmercury does, and
19 in fact, the dentists in that study -- 60 percent of the
20 cohort was dentists, and they actually had higher total
21 mercury levels than the cohort as a whole, but we have
22 no idea how much of that was methylmercury. Most of it
23 would have been inorganic mercury from exposure to
24 mercury vapor in their dental practice.
Page131
1 Q. Does the fact if they are exposed to
2 mercury vapors then it's probably inhaled as opposed to
3 ingested?
4 A. Yes.
5 Q. Does that make a difference from what you
6 know?
7 A. Yes. It will make a difference in the
8 distribution, and it will also mean that none of it gets
9 converted into methylmercury in the body. It goes into
10 the blood. It's mercury vapor. It's elemental mercury,
11 which is reactive, and it will be changed into inorganic
12 mercury, but that's not methylmercury and the effects
13 can be quite different.
14 Q. Thank you.
15 MR. BONEBRAKE CONTINUES:
16 Q. In that testimony, Dr. Rice, you state --
17 and again, it's at page six of your testimony. In a
18 study of male health professional in the US, a
19 non-statistically significant relationship was found
20 between coronary heart disease and toenail mercury
21 levels after dentists were excluded from the analysis.
22 Is it typical for toxicologists to rely upon
23 non-statistically significant results?
24 A. No. I mean, if that were the only study,
Page132
1 one would want to say that replicated. The problem was
2 that, by the time they eliminated 60 percent of their
3 cohort, they didn't have a whole lot of statistical
4 power to detect an effect because they didn't have very
5 many people left. Now, it could be that it's the lack
6 of power that led to the non -- to the fact that it was
7 not statistically significant or it could have been
8 that, really, there wasn't any effect there and it's
9 hard to interpret that on the basis of just one study,
10 but there are other studies that did find statistical
11 effects, and you have to add that piece of evidence into
12 the rest of the evidence.
13 Q. But would you agree that, typically, a
14 toxicologist would not rely upon a non-statistically
15 significant result?
16 A. It depends on the context. I wouldn't say
17 that categorically, no.
18 DR. RICE: "What factors cause heart
19 disease?" We're on 26 now? "What factors cause heart
20 disease in men?" Well, you know, the only information I
21 have on that, really, is probably what everybody else
22 reads. It's really not my area, but obviously, there's
23 a constellation of things that produce heart disease in
24 men related to lifestyle, lack of exercise, food intake,
Page133
1 various aspects of foods intake, probably genetics, as
2 well as potentially environmental factors, environmental
3 contaminants, like lead, for example, and methylmercury.
4 DR. RICE: 26-A: "How many of these
5 are mercury related?" I think that the mechanism --
6 see, now, I don't really know how much is known about
7 the mechanisms of other factors that are involved in
8 heart disease. How do you get from taking in high
9 cholesterol to heart disease? The biochemical mechanism
10 is unfamiliar to me. It's just not my area, but I know
11 that in the finished study of the effects of
12 methylmercury, elevated hair methylmercury -- hair
13 mercury was associated with elevated oxidized LDL
14 levels, which are a risk factor for heart disease, and
15 there was also an increase in carotid wall thickness in
16 the finished study, which is another risk factor for
17 heart disease, and I guess that's really the only thing
18 I can say about, that and the mechanisms of
19 methylmercury toxicity related to heart disease are
20 really not very well characterized, either, in humans or
21 in animals, so there's a limited amount of data
22 available I think. "In her testimony, Mr. Rice
23 indicated there's an association between methylmercury
24 and heart cardiovascular disease. Is there currently a
Page134
1 level of uncertainty concerning such association?"
2 Those questions are always hard to answer because it
3 very often depends on who you are talking to, what
4 circles you run in. That's like saying, "Is there
5 uncertainty about global warming?" Not among the vast
6 majority of researchers, but that doesn't mean that
7 there's nobody out there who won't say there's no
8 evidence of global warming. However, I think that the
9 evidence for the relationship between cardiovascular
10 disease and methylmercury is probably less strong than
11 that. "Is Dr. Rice aware of any studies reporting an
12 inverse association between fish consumption and
13 cardiovascular effects, i.e., fish consumption has a
14 protective effect against cardiovascular disease?" Yes.
15 There certainly are studies out there, but there's
16 also -- there are also studies that say that fish intake
17 may be protective up to a point, but when you get too
18 much methylmercury in your body, then that protective
19 effect goes away and actually reverses, so having too
20 much methylmercury in your body then contributes to risk
21 for cardiovascular disease.
22 MR. BONEBRAKE CONTINUES:
23 Q. I had a follow-up. I think the question
24 before when you were talking about uncertainty, would it
Page135
1 be your view, Dr. Rice, that there are other experts in
2 the field that have the view that there has not been an
3 established connection between methylmercury consumption
4 and cardiovascular effects?
5 A. I'm sure that there are people out there
6 that would say that and I think there are other issues
7 about trying to quantify those effects. The
8 relationship between exposure and effect has been
9 quantified, unlike this graph here where it has been
10 quantified. Is there a threshold for adverse effect?
11 We don't know, and that makes a big different when you
12 are trying to do cost benefit analysis or
13 quantification. The other issue or another issue is
14 that a couple of these studies that really found an
15 effect a robust effect, relied on toenail methylmercury,
16 or toenail mercury concentrations, so that's fine for
17 establishing an effect, a relationship, but then how do
18 you get the same issue we were talking about this
19 morning. How do you get from toenail mercury back to
20 intake? We just don't know how to do that, yet, so
21 using these studies for quantification really requires a
22 lot more talk among groups of experts I think to do
23 that.
24 DR. RICE: "Are such results found in
Page136
1 the Chicago Western Electric Study in Japan and the
2 Nurse's Health Study and the U.S. Physicians' Health
3 Study?" Yeah. I'm aware of these studies. I have
4 looked at these studies. I think probably the best one
5 of these is the U.S. Physicians' Health Study. The
6 problem with all of these studies is something that we
7 have talked about already, and that is these are not
8 randomized controlled studies. In other words, people
9 choose to eat fish or not. They choose to exercise.
10 They choose to eat vegetables. Increased fish
11 consumption in the United States might be a surrogate
12 for healthy lifestyle. The folks that looked at this,
13 by far the best, are the folks that did the U.S.
14 Physicians' Health Study because they tried to control
15 for exercise and intake of other foods, of red meat, of
16 vegetables of various dietary nutrients and tried to
17 control for those when they looked at the benefits of
18 fish consumption on the cardiovascular effects, but just
19 recently, last week, or the week before, out of this big
20 cohort, this big longitudinal cohort that's been
21 followed now for many years, is an increase in atrial
22 fibrillation associated with increased fish consumption
23 in this cohort, which doesn't take away the benefit that
24 is they found on myocardial infarction and so forth, but
Page137
1 immediately people started saying, "Well, you know there
2 are uncontrolled confounders out there. These people
3 probably have a really healthy lifestyle, and that's not
4 being captured. They exercise all the time and that's
5 why there's increase in atrial fibrillation." So you
6 really can't have it both ways.
7 MS. BASSI CONTINUES:
8 Q. I'm sorry. What does "increase in atrial
9 fibrillation" mean? Is that good or bad?"
10 A. It's a bad thing.
11 Q. Thank you.
12 DR. RICE: Before I launched into this
13 big explanation, yeah.
14 MADAM HEARING OFFICER: That only a
15 handful of us would have understood. Not me.
16 DR. RICE: 28: "How does the
17 methylmercury reference dose of .1 microgram per
18 kilogram per day relate to cord blood concentrations
19 relate of 5.8 micrograms per deciliter?" It's the same
20 for Boston naming Test, and again, we talked about that
21 at great length this morning. It's only one blood
22 level. There are other blood levels out there. The
23 integrative analysis that was done by Dr. Ryan would
24 yield a level of about 3.4, for example, so that's how
Page138
1 it relates.
2 MR. BONEBRAKE CONTINUES:
3 Q. Does cord blood concentration of 5.8
4 micrograms per liter, does that incorporate U.S. EPA's
5 uncertainty factor?
6 A. Yes.
7 MS. GEERTSMA CONTINUES:
8 Q. This is backing up to the atrial
9 fibrillation, not to belabor it, but just a
10 clarification. Did you mean that recent analyses of
11 that cohort have shown that there is, in fact, a
12 negative cardiovascular outcome associated with
13 increased fish consumption?
14 A. Yes.
15 DR. RICE: "What is the basis for
16 Dr. Rice's statement on page seven of her testimony that
17 16 percent of U.S. female population of childbearing age
18 had blood levels of methylmercury greater than 3.4
19 micrograms per deciliter?" Again, that's from NHANES
20 and it's, specifically, by a study, a publication by
21 Catherine McHaffey (phonetic) who is an investigator at
22 EPA who has access to the NHANES data base.
23 MR. BONEBRAKE CONTINUES:
24 Q. Just for clarification, the NHANES survey,
Page139
1 though, addressed mercury concentrations in hair. Is
2 that correct?
3 A. No. It has blood and hair.
4 DR. RICE: 30: "Does Dr. --
5 MADAM HEARING OFFICER: Mr. Forcade
6 had a question.
7 MR. FORCADE CONTINUES:
8 Q. Excuse me. I've noticed that there has
9 been a subtle shift here occasionally in the reference
10 to a certain amount per deciliter and a certain amount
11 per liter?
12 A. Then I misspoke. I'm sorry. It's per
13 liter. I'm an old lead person and we do deciliters.
14 Q. Just wanted to clarify.
15 DR. RICE: Thank you. 30: "Does
16 Dr. Rice contend that there has been a reduction in IQ
17 in the U.S. population over time?" I think we covered
18 that this morning.
19 MS. BASSI: Would you repeat that,
20 please? What was your answer?
21 DR. RICE: No. 31: "Is mercury a
22 natural occurring element?" Yes. A: "Was
23 methylmercury present in fish from natural sources, even
24 prior to the industrial revolution?" I have no direct
Page140
1 knowledge of that or information about that, but I would
2 assume that it must have. B: "Is methylation of
3 mercury a natural process?" Yes. C: "Even without
4 anthropogenic sources, would some level of methylmercury
5 be present in the environment and in fish?" and again, I
6 gave the example this morning of fires and volcano, and
7 so I'm assuming that surely must be true. There was
8 also anthropogenic sources of methylmercury emission
9 because the Greeks and other European societies mined
10 mercury hundreds of years ago.
11 DR. RICE: 32: "Does Dr. Rice have an
12 economic degree or any training regarding economic
13 analysis?" No, I don't. I have a Ph.D. in toxicology.
14 33: "What is the basis for Dr. Rice's conclusion
15 regarding loss earnings among the women with mercury in
16 their blood levels and their children?" This is really
17 not my analysis. I can't speak to it with any authority
18 at all. I included it in my review for the sake of
19 completeness, just to let the Board know that these kind
20 of analyses are out there, but as I answered previously,
21 I don't have an economic degree, and I don't know how to
22 do this modeling and this cost benefit analysis, so I
23 can't speak with any expertise to I think any of this
24 question.
Page141
1 MR. BONEBRAKE CONTINUES:
2 Q. Just for purposes of clarification,
3 Dr. Rice, what is in your testimony and reports attached
4 to the TSD with respect to societal costs or benefits
5 associated with methylmercury or methylmercury control
6 are simply a reiteration of what you have read from
7 other people's work?
8 A. Only as it applies to the monetization,
9 the Trasande, et al., paper, which I think is the only
10 one I talked about in terms of monetization. The other
11 things that are in there about the fact that
12 cardiovascular effects have not been included, and we
13 have talked about the strength of the evidence for
14 those. That, potentially, is something that maybe
15 monetized in the future that isn't captured. I also
16 talk about the fact that IQ predicts all kinds of other
17 things, besides lost wages, which we talked about this
18 morning. I'm very familiar with the National
19 Longitudinal Survey of Youth. It's a database from the
20 Department of Labor, and that was the basis of the
21 statements that I made this morning, so I don't back off
22 those statements at all. It's just with regard to the
23 monetization. I don't know how to do monetization.
24 Q. Just to make sure I understand, your view,
Page142
1 as you are an expert in the area of identifying the
2 types of impacts that someone who is monetizing should
3 take into consideration, but you're not an expert in the
4 monetization process?
5 A. That's exactly right, yes. I think I used
6 the example, for example, when EPA did its monetization
7 for led. The cardiovascular effects being a lot more
8 costly than the lost wages.
9 MADAM HEARING OFFICER: Ms. Bassi, did
10 you have a follow-up?
11 MS. BASSI: At the end I think,
12 please. Thank you.
13 MADAM HEARING OFFICER: I need to make
14 a point of clarification, actually. This question
15 refers to Appendix A, page 28? Is that of Dr. Rice's
16 testimony? TSD?
17 MR. BONEBRAKE: That one actually is
18 directed to the TSD, but there's also some testimony, as
19 well, that deals with -- I think you're heading is
20 "Societal Costs" in your testimony, so this issue was
21 addressed both places.
22 MADAM HEARING OFFICER: Just wanted to
23 clarify where that was in the record. Thank you.
24 DR. RICE: 34: "One of the reports
Page143
1 that Dr. Rice discusses in her report to Illinois EPA is
2 that of Trasande, et al. A: Are the authors of the
3 Trasande, et al., report pediatricians?" I don't know
4 about Dr. Schetker (Phonetic) but, both, Dr. Landervan
5 (phonetic) and Dr. Trasande are pediatricians.
6 Dr. Landervan is head of -- he's at Mt. Sinai, and he is
7 head of the Center for Children and -- Children and
8 Environmental Health, or something, and Dr. Trasande is
9 the associate director, and this team of authors has
10 authored other reports on monetization of these kinds of
11 effects. They have done a similar analysis for lead.
12 They have also done analyses for other decrements
13 associated with childhood diseases, such as learning
14 disabilities and asthma. The societal burden cost of
15 some of the pollutants that are out there.
16 Dr. Landervan has worked in the area of
17 neuropsychological effects of contaminant in children
18 for three decades. He's very inter nationally renowned,
19 very distinguished professor. "Are they economists?" I
20 don't know if Dr. Schetker is an economist or not. I
21 only know the other two. C: "Is Dr. Rice aware of the
22 corrections that Trasande report authors must make
23 following a critical analyses by U.S. EPA economists?"
24 I submitted my report in March, and in April, EPA put up
Page144
1 what they call "A note to Trasande" at Trasande, et al.,
2 on their website in which they state that Trasande, et
3 al., will be publishing a letter in Environmental Health
4 Perspectives adjusting I guess their analyses, their
5 monetization because they made a mistake in their
6 calculations, and I'm aware of the note. I've read the
7 note. I have not seen the letter. I looked right
8 before I came to see if the letter was up on
9 Environmental Health Perspectives, yet and I couldn't
10 find it. They are not -- I don't know about "must
11 make." I mean, scientists if they find an error or an
12 error is pointed out, they make the correction, or they
13 publish a retraction or a correction, or whatever it is
14 they have to publish.
15 MR. BONEBRAKE CONTINUES:
16 Q. Dr. Rice, do you know if that correction
17 has been made at this point?
18 A. I think I just testified that I looked for
19 the letter on the Environmental Health Perspectives
20 website, and I couldn't find it. If it's gone up, it's
21 gone up in the last few days, and that's all I know. I
22 don't have any personal knowledge of that.
23 DR. RICE: D: "Is Dr. Rice aware that
24 Trasande, et al., must retract their initial conclusions
Page145
1 and substantially lower their estimates of the cost of
2 power plant mercury emissions?" Again, that's what EPA
3 says on its website in their note and they explain the
4 way -- the mistake that Trasande, et al., made, and it
5 would result in about a tenfold decrease in their
6 estimates for monetization, but I haven't seen the
7 Trasande, et al., calculations. They, I guess,
8 misunderstood that it was a tenfold -- the IQ decrements
9 were over tenfold and not a onefold, but again, EPA has
10 a document out there on its website, and as far as I
11 know, that's as far as its gone right now.
12 MR. BONEBRAKE CONTINUES:
13 Q. So it's your understanding, Dr. Rice, that
14 the projected costs that were earlier considered in the
15 Trasande analysis would be reduced to about 10 percent
16 of what they originally projected?
17 A. According to EPA, and that's all I know.
18 I really -- as far as I know, the letter isn't out, so I
19 really can't say anything more than that. I don't know
20 whether Trasande, et al., are going to agree, so I know
21 it's on EPA's website and that's all I know. 35: "At
22 page eight of her testimony, Dr. Rice refers to a
23 Department of Labor survey of IQ's, and the impact of a
24 3 percent reduction in IQ's. Is Dr. Rice aware of any
Page146
1 study or report indicating that consumption of fish has
2 caused a 3 percent or greater decline in IQ in Illinois
3 residents?" I don't know anything specific to Illinois.
4 We have very good data on the relationship and we have
5 several analyses now on the relationship between IQ and
6 methylmercury intake. I would assume that it wouldn't
7 be substantially different in Illinois. I don't know
8 about the Great Lakes. I know that in coastal states,
9 including the East and West Coast and in the Gulf,
10 people in those states, in general, eat more fish and
11 their mercury levels are higher, and that comes from
12 NHANES those are NHANES data. To my knowledge, the
13 Great Lakes states have not been broken out, and whether
14 that would be true around the Great Lakes, I don't know.
15 CDC, Center for Disease Control, who are the people who
16 do the NHANES database are very, very careful to the
17 degree to which they are willing to break down their
18 data because they have to be very careful that
19 individuals are not recognizable on their database, so
20 you can't, for example, get state-specific data. It's
21 just too small an area, too few number of people for CDC
22 to publish on.
23 MR. BONEBRAKE CONTINUES:
24 Q. You mentioned the coastal states. Is it
Page147
1 also true that the populations in those coastal states
2 eat more ocean fish than do the populations in states
3 such as Illinois, which are inland?
4 A. I'm not sure that -- I mean, that's a
5 pretty obvious and interesting question. I don't think
6 that anybody's published on that, whether that's true to
7 their increase -- due to their increase of consumption
8 of ocean fish. I don't know.
9 Q. Make sure I understand. Your testimony
10 was that the coastal state populations have higher
11 levels of fish consumption and higher mercury levels in
12 their bodies?
13 A. They have higher levels of mercury in
14 their bodies, and there are some data that they also
15 have higher levels of fish consumption, but to my
16 knowledge, it hasn't been broken down. I haven't seen
17 data published or even unpublished that break it down in
18 terms of ocean versus freshwater fish.
19 DR. RICE: 36: "Are there any
20 peer-reviewed studies that definitely attribute, in
21 Illinois, or even in the United States, neurological or
22 physical impairment to consumption of methylmercury in
23 freshwater fish?" To my knowledge, that hasn't been
24 done. I mean, you're interested in the amount of
Page148
1 mercury, the relationship between methylmercury and
2 performance and the effect, and then you need data -- I
3 mean, if you really are concerned about freshwater fish,
4 specifically, then you need data on relative consumption
5 patterns, how much freshwater fish do people eat and how
6 much mercury is in that freshwater fish, and from there,
7 it's a straight extrapolation to how much of a deficit
8 there would be. To my knowledge, nobody has done that,
9 certainly not specific to Illinois. I don't know why
10 you would do that exercise, frankly. 37: "What is the
11 main source of methylmercury exposure in the U.S.?" I
12 think that was also Question 3 or something. Fish. 38:
13 "Is demethylation of methylmercury in the body necessary
14 for a toxic effect to occur?" That's also a very
15 interesting question. Methylmercury in the adult brain
16 is demethylated. It goes into the brain, and then some
17 of it, at least, is demethylated, and it's an open
18 question whether some of the toxic effects, particularly
19 delayed neurotoxicity, is a function of how much
20 inorganic mercury is in the brain because, once it is
21 demethylated, it doesn't come back out. Now, inorganic
22 mercury doesn't get into the brain, so it's not like the
23 inorganic mercury in the blood is getting into the brain
24 and producing an effect. Really, it's the methylmercury
Page149
1 that's going across what's called the blood brain
2 barrier, and then some of it is demethylated. How much
3 of that is responsible for the neurotoxic effects? We
4 don't really know. We have been studying methylmercury
5 for 30 years or more, and we still don't know the answer
6 to that question. For the fetus, though, methylmercury
7 doesn't really have enough time to be substantially
8 demethylated, so surely, in that case, it's
9 methylmercury that's having all, or most, producing all
10 or most of the neurotoxicity.
11 MR. BONEBRAKE CONTINUES:
12 Q. If methylmercury is demethylated, is it no
13 longer toxic to human beings?
14 A. I thought I answered that. I guess I'm
15 not being clear. It's unknown in the brain. The degree
16 to which the methylmercury that's demethylated and then
17 stays in the brain is contributing to the neurotoxic
18 effects, particularly delayed neurotoxicity during
19 aging. Maybe it's a major player, but we just don't
20 know. For other organ systems, like the kidneys, for
21 example, there's no question that inorganic mercury
22 produces toxicity.
23 DR. RICE: 39: "Is Dr. Rice's
24 conclusion that the risks of eating fish outweigh the
Page150
1 benefits of ingesting omega-3 fatty acids supported by
2 other experts?" I guess what's being said here is the
3 assertion that I think that we shouldn't eat fish, and I
4 don't agree with that. I don't think I have ever said
5 they thought that people shouldn't eat fish, that
6 injection of fish outweighs the benefits of ingesting
7 the omega-3 fatty acids, so I guess I can't answer that
8 question the way it's worded. I might say, though, that
9 there was an analysis done by the Harvard Center for
10 Risk Assessment, and it was done for the fishing
11 industry. It was paid for by the Tuna Foundation in
12 which they looked at the benefits of, potential
13 benefits, of omega-3's to the development of the fetus,
14 and they also looked at the decrements produced by
15 methylmercury and they did so under various scenarios,
16 including various kinds of increased fish consumption,
17 either paying attention to how much methylmercury is in
18 fish or not paying attention to how much methylmercury
19 is in fish, and in every case, the IQ loss produced by
20 consumption of -- of methylmercury in fish outweighed
21 the benefits. Any potential benefits from omega-3 fatty
22 acids.
23 MR. BONEBRAKE CONTINUES: Hang on for
24 just a second. I'm looking at the report reference.
Page151
1 MS. BASSI CONTINUES:
2 Q. I would like to go back to where you were
3 discussing about IQ and the decrements in IQ and so
4 forth, and at various times today, and in your testimony
5 I think in your testimony, but at least today, you
6 stated that IQ in the United States is not decreasing,
7 but that there are monetary or economic losses due to
8 the effects of methylmercury ingestion due to the loss
9 in IQ or to IQ decrements, and these, to me, seem
10 diametrically opposed. If IQ is increasing, where are
11 the decrements? Or are you saying that we would all be
12 real geniuses.
13 A. If we didn't eat mercury? Yeah. I mean
14 these are relative. I mean, they have to be relative
15 because, if we were all really stupid, I guess we would
16 all have our same jobs and our same salary. I don't
17 know if that's true or not, but within a population, IQ
18 predicts all of these things, including lost wages, and
19 so it's relative to everybody else in the population at
20 that time. I mean, I guess it really doesn't account
21 for -- if IQ 30 years ago was higher or lower than it is
22 now, so it's really a very kind of short term effect. I
23 mean, even though it's over the lifetime of the
24 individual, it's short term in that way. I mean, it's
Page152
1 not subject to sort of these longterm 100-year
2 fluctuations in IQ.
3 Q. Well, it also seems strange to me that you
4 say that increased consumption of fish occurs among
5 women who are have higher IQ's and more education and
6 more money, and if this is true, but eating fish results
7 in IQ decrements in their children, again, it just seems
8 inconsistent to me. Maybe it's statistics? Maybe it's
9 just that.
10 A. No. I'm assuming that that relationship
11 now represents more educated women's awareness of all of
12 the health advice about eating healthy, eating your
13 vegetable and exercise. I don't think it's reflective
14 of what they were eating when they were two.
15 Q. Okay.
16 MADAM HEARING OFFICER: Are there any
17 other questions for Dr. Rice? Going once? All right
18 then I guess we're through with Dr. Rice. Thank you
19 very much.
20 MR. KIM: What we were going to do
21 next was the testimony that sort of accompanied
22 Dr. Rice's testimony concerning health impacts was also
23 going to be presented by Jeff Sprague of the Illinois
24 EPA and he has received some prefiled questions, and
Page153
1 he's prepared now to answer those. We would probably
2 keep Dr. Rice on the panel and just as sort of a preface
3 to Mr. Sprague's testimony, he was really identified as
4 a witness way back when we had the original hearing
5 schedule and there was some concern that Dr. Rice, from
6 a logistical standpoint, was not going to be available
7 and he can get into more of this in his testimony,
8 obviously, but I guess I just want to sort of point out
9 that Mr. Sprague is -- was offered up as sort of a
10 back-up to Dr. Rice, so there is some of the questioning
11 that is sort of redundant, and I'm sure he will explain
12 how many of the questions he would have forced off on
13 Dr. Rice, anyway.
14 (A small break was taken.)
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Page154
1 STATE OF ILLINOIS)
2 COUNTY OF ST. CLAIR)SS
3
4 I, Holly A. Schmid, a Notary Public in
5 and for the County of Williamson, DO HEREBY CERTIFY that
6 pursuant to agreement between counsel there appeared
7 before me on June 13, 2006, at the office of the
8 Illinois Pollution Control Board, Springfield, Illinois,
9 Dr. Deborah Rice, who was first duly sworn by me to
10 testify the whole truth of her knowledge touching upon
11 the matter in controversy aforesaid so far as he should
12 be examined and her examination was taken by me in
13 shorthand and afterwards transcribed upon the typewriter
14 (but not signed by the deponent, and said deposition is
15 herewith returned.
16 IN WITNESS WHEREOF I have hereunto set
17 my hand and affixed my Notarial Seal this 21st day of
18 June, 2006.
19 __________________________
20 HOLLY A. SCHMID
21 Notary Public -- CSR
22 084-98-254587
23
24
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