ML20203J988
| ML20203J988 | |
| Person / Time | |
|---|---|
| Issue date: | 12/16/1997 |
| From: | NRC ADVISORY COMMITTEE ON NUCLEAR WASTE (ACNW) |
| To: | |
| References | |
| NACNUCLE-T-0119, NACNUCLE-T-119, NUDOCS 9712220150 | |
| Download: ML20203J988 (135) | |
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R 3 \\ A_ /f#MF O//9 OFFICIAL TRANSCRIPT.0F PROCEEDINGS g
NUCLEAR REGULATORY COMMISSION ADVISORY COhlh11TTEE ON NUCLEAR WASTE
Title:
.97Til ADVISORY COhthilTTEE ON NUCLEAR WASTE (ACNW) AfEETING Docket No.:
TR08 (ACHW)
RETURN ORIGINAL TO BJWHITE, ACRS T-2E26 415-7130 t
TVork Order No.:
ASil-300-82 THANKS!
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LOCATION:
Rockville,hlar3land DATE:
Tutsday, December 16,1997 PAGES: 1 132 b
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(202) 842 0034 O01 AONWOFDCECOPY-R$TAIN FOR THEUFEOFTHE00E%TfEE -
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t DISCLAIMER UNITED STATES NUCLEAR REGULATORY COMMISSION'S ADVISORY COMMITTEE'ON NUCLEAR WASTE DECEMBER-16, 1997' l
The contents of this transcript of-the proceeding of the United States Nuclear Regulatory Commission Advisory O
- \\g
-Committee'on Nuclear Waste, taken on December 16, 1997, as reported herein, is a record of the discussi'ons recorded at the meeting held on the above date.
This transcript had not been reviewed, corrected and edited and it may contain inaccuracies.
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1 1
UNITED STATES NUCLEAR REGULATORY COMMISSION
(
2 ADVISORY COMMITTEE ON NUCLEAR WASTE 3
4 97TH ADVISORY COMMITTEE ON 5
NUCLEAR WASTE (ACNW) MEETING G
7 U.S. Nuclear Regulatory Commission 8
'Two White Flint North, Room 28-3 9
11545 Rockville Pike 10 Rockville, Maryland 20852-2738 11 12 Tuesday, December 16, 19Fi 13 14 The Committee met pursuant to notice at 8:32 a.m.
15 16 MEMBERS PRESENT:
17 B. JOHN GARRICK, Chairman, ACNW 18 GEORGE HORHBERGER, Vice Chairman, ACNW 19 F. FAIRHURST, Member, ACNW 20 RAYMOND G. WYNER, Member, ACNW 21 HAROLD LARSON, Member, ACNW 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:
2 RICHARD K. MAJOR, STAFF-
-3 GIORGIO'GNUGNOLI,'ACNW STAFF 4
-ANDREW C. CAMPBELL, ACNW STAFF l
s 5
LYNN DEERING, ACNW STAFF-6 JOHN W. SORENSEN 7
CARL PAPERIELLO, NMSS 8
VINCE HOLAHAN, NRR 9
MYRON POLLYCOVE, NMSS 10-SHLOMO YANIV, NRR i
.11 l
12 13 14 l
O 15 16 17 i
18 19 20-21 22 i
23 r
24
'25-I ANN-RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street,-N.W., Suite 300 Washington, D.C.
20005 (202) 842-0034.
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3 1
PROCEEDINGS
()
2
[8:32 a.m.]
3 MR. GARRICK:
The 97th meeting of the Advisory 4
Committee on Nuclear Wasta will now come to order.
5 This is the first day of the meeting.
My name is G
John Garrick, Chairman of the ACNW.
7 Other members of the committee include George 8
Hornberger, Ray Wymer, and Charles Fairhurst.
9 The entire meeting will be open to the public.
10 During today's meeting the committee will first review the 11 latest developments in the biological effects of low levels 12 of ionizing radiation; second, meet with the Director of 13 NRC's Division of Waste Management to discuss items of 14 current interest; third, the ACNW Staff will present a short r
15 tutorial on the Commission's low level waste regu'1ations in 16-10 CFR, Part 61; and fourth, we will prepare ACNW reports 17 on, first, ACNW strategic plan and priorities for 1998, 18 calendar years second, we will start the process of 19 developing a letter on low levels of ionizing radiation; and 20 third, the high level waste resolution status reports.
21-Richard Major is the designated Federal official 22 for today's initial session.
23 The meeting is being conducted in accordance with 24-the_ provisions of the Federal Advisory Committee Act.
We 25 have received no written statements or requests to make oral
[b ANN RILEY & ASSOCIATES, LTD.
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statements from members of the public regarding today's
/s
( )
2 session.
3 Should anyone wish to address the committee, 4
please make your wishes known to one of the members or one 5
of the committee staff.
6 It is requested that each speaker use one of the 7
microphones, identify themselves, and speak with sufficient j
l 8
clarity and volume so that they can be readily heard.
9 Before proceeding with the first agenda item, I 10 would like to cover some brief items of current interest.
11 It's kind of a slow month --
12
[ Laughter.)
13 CHAIRMAN GARRICK:
At the Yucca Mountain project 14 the drift scale heater tests began on December 3rd, 1997.
IO q,/
15 The former Westinghouse Electric Corporation, now known as 16 CBS Corporation, is seeking buyers for both its Savannah 17 River site operating contract and its commercial nuclear 18 fuel manufacturing plant near Columbia, South Carolina.
19 The Southeast Low Level Waste Compact Commission 20 voted Monday to suspend funding for development of a 21 proposed low level radioactive waste site in the state of 22 North Carolina.
The Chairman said the Commission is 23 concerned because of a projected $7 million spending 24 shortfall expected to occur in May, 1999.
25 Finally, 26 utilities have petitioned the Federal b
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Appeals Court to permit them to stop making payments to the j
(OD 2
Department of Energy for the Federal Nuclear Waste Fund 3
because DOE has not honored a legal requirement to begin 4
taking spend commercial nuclear fuel.
5 Unless there's questions, comments, clarifications 6
by members of the committee I think we will proceed to the 7
first item on our agenda and Ray Wymer is the cognizant 8
member for the subject, and the subject 2-t he health 9
effects of low level ionizing radiation.
10 MR. WYMER:
Thank you, John.
As I told John a 11 little earlier, I think that the word " cognizant" might be a 12 little strong since several of us here are brand new to this 13 subject and one of the things we hope to do this morning is 14 to learn some of the background and hear some of the experts
()
15 in the field present their views on the subject.
16 Abou" a year and a half ago, in March of 1996, 17 there was a subcommittee meeting jointly between the ACRS 18 and the ACNW where this topic was reviewed, and now a year 19 and a half later we are hoping to both receive information 20 on the background of the field, those of us who are new 21 members, that we are fairly unfamiliar with, and also to 22
-learn what new has happened since a year and a half ago.
23 One of the things that happened very recently was 24 the meeting in Seville of the International Conference on 25 Health Effects of Low Radiation Doses, which was sponsored
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by the IAEA and the World Health Organization, and we have l
I'
(_)d 2
several people here who attended that meeting and we hope to 3
get some discussion and some input to see what the advances 4
are or the moves are of the new positions in the field are, 5
if any.
6 It's a very difficult topic, as I am learning from 7
reading some of the background material in that the doses 8
that are involved are so low that it is hard to sort the 9
facts out of the noise.
10 At any rate, let's get on with it.
From now till 11 Noon we will have discussions in this area.
12 We are starting out with Dr. Myron Pollycove, 13 Visiting Medical Fellow here at the NRC, and we'd appreciate 14 it if you would just start right out and tell us what you
()
15 want to tell us.
16 DR. POLLYCOVE:
Well, I greatly appreciate the 17 opportunity of addressing the committee.
Quite a bit has 18 transpired in the past year and a half, particularly the 19 linear no threshold hypothesis is undergoing increasingly 20 critical scrutiny this year.
21 During the past seven months, I participated in 22 the following six conferences.
Vincent Holahan will address 23 the current re-examination of LNT by the NCRP, which is 24 being funded by the Nuclear Regulatory Commission, and a 25 National Academy of Sciences workshop was held in July on
[]/
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the impact-of biology on-risk assessment of radiation 2'
' effects as part of an initial study to determine the need 3
..for BEIR VII examination of low dose radiation effects..
4 Both-of-these sessions or meetings will be 5
addressed by Vince Holahan, j
6 In' addition.to these two, sessions of the annualL 7-meetings of the American Physician Society in April and the 8
American Nuclear Society in June also questioned the
~
9 validity of LNT.
- The Council of Scientific Society Presidents held
' a conference July 31st to August 3rd on perspectives and I a
12-think this is included in your handout -- the perspectives
{
13
, of creating a strategy for sciance-based national policy 14 ~
addressing conflicts of the scientific views on the health j
15
. risks of low level ionizing radiation -- that is a rather 16
- long title for a conference, but I think it accurately 17 reflects the current status, that there is -- the views are l
?
18 conflicting and the need for resolution of this-conflictEis---
19 obviously of great importance because of not only the 20
- enormous cost of remediation but possible detriment to the 21 --
- health of the. population.
22 This handout contains an index of 40 submitted 23-
!two-page' position summaries, of which 21 are included-in 124
'this so as-to keep it'under the 35 page limit that our' l
25-machines will staple,_but they are representative and the 40 ANN RILEY & ASSOCIATES, LTD.
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papers that are listed here in the index, of the 40
()
2 positions, one might classify nine of them as strongly 3
supporting LNT, four strongly supporting evidence of 4
hormeisis -- of course, which if finally demonstrated 5
conclusively would naturally end LNT -- and the 27 others 6
are riding the middle ground, supporting a practical 7
threshold, saying that we have to really balance the costs C
to society of pursuing a hypothesis to the nth degree versus 9
practical safeguards in an area where no harm has ever been 10 clearly demonstrated.
11 In fact, at the conclusion of this conference 12 there was agreement that no significant harm has been 13 demonstrated at or below 20 centiseiverts, and then a 14' subsequent draft of an accord was distributed which not only
()
15 said that nothing was seen below 20 but that there was a 16 wealth of evidence that demonstrated linearity above 20, and 17 it was this added new conclusion which was not made ar. the 18 end of the conference that gave rise to a good deal of the 19 dissention.
20 The disagreement with this subsequent draft has 21 led to a difficulty in getting a final report out, which has 22 still not been released.
23-Nou this was followed - 'this was held in early.
24 August, July 31st to August 3rd, and then more recently we 25
'have had this International Conference on Low Doses of
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. Ionizing ~ Radiation, biological effects and regulatory
()
'2 control,'which was sponsored by the'IAEA and_UNSCEAR, with 3
participation of'other WHO -- I think it was WHO and IAEA
'4-
'and UNSCEAR also participated in that.
5 This was held in Seville the 17th to the 21st of j
.6 November.
7 Now.I believe that you all have this program that l
t l8
'you might have'in full page, but essentially shows what the 9
program was in Seville, and.on the timetable you can see I
10 quickly on the timetable which shows Monday through Friday 11 the headings of the different parts of the program.
12 On the first day, reports of international 13 organizations on biological effects and reports of related P
14 international-conferences -- now-one of these reports'had to
()
15-do with Wingspread and Warren Sinclair said that there was i
-idt some dissention on the final draft -- not final draft -- on 17 the last draft, which was -- he was a large contributor to 18
.that-draft, and consequently he said that it was his 19 ~
personal opinion that there was a wealth of evidence to 20 support LNT above 20 rad.
.21 On the second day you can see molecular mechanisms.
22 of radiation effect; adaptive responsess enhanced repairLin
-23 apetosisi multistage processes of inducing malignancies;
)
24 hereditary effects, t
2Si
.Then on Wednesday, epidemiologic evidence; i
' O=
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radiobiological issues in the application of epidemiologic
()
_2 evidence; and then the effect of low doses on human health;-
3 radiation risk estimates.
Then we got rare into the 4
regulatory and formal recommendations, a special session on 5
the scientific evidence that leads to radiation protection; 6
control measures for practices causing exposure; reduction l
7 of existing' doses; chronic exposure.
i 8
Then-finally'the-windup on Friday, the regulatory 9
control on scientific research, and this was a roundtable.in 10 which Dr. Paperiello presented his views and I think we have 11 just distributed that, and then the conference summary 12 session in which Commissioner Dieus introduced the Chairs of 13 each of the previous portions'of the program, and the 14 closing of the conference.
()
15 Now I believe that the best summary, and we don't P
16 have time for it, to go into detail,.I'll just touch a few 17 highlights, is the one that Ann Maclachlan wrote up for 18-Nucleonics Week, and the three issues which have been 19' distributed to you of November 20th, 27th, and finally 20 December 4th I believe was the last.
21 On the very first page of the November 20th, she 22-points out-that there is a disagreement over radiation 23 benefits and this-surfaced at the Seville meeting.
And, of l
-24.
Lcourse, the minority that-were vocal argued that radiation
. 25<
-protection is suppressing or twisting data that shows a (f-Court Reporters ANN RILEY.& ASSOCIATES, LTD.
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small amount of radiation is beneficial.
(
)
2 The conference -- the great majority of the 3
members of the conference.were official representatives from 4
these different radiation protection committees, and l
5-submitted by the government, who have these radiation 6
protection policies in effect.
t On the -- on the second page of-November 20th, it 8
says that the chairman of Spain's Nuclear Safety Council, 9
and also the chairman of the entire conference, said that 10
-the discussion on research results and needs, as well as on 11 health impacts are essential because the world community 12~
must try to agree where our resources should be spent.
And 13 this was why -- really,-was the underlying motivation for i
14 the Wingspread Conference as well.
l
(
15
~ And WHO Director General, Hiroshi_Nakajima, said 16 that the public needs, quote, " reliable information,"
17 unquote, on low dose health effects.
Or else radiation l
18 effects will be multiplied to an unnecessary extent by fear.
19 And he targeted the validity of the LNT model as one of the 20
_ key issues of the conference, along with the long-term i
21 genetic effects of radiation.
22 Now,-no genetic effects were -- have been 1
23-demonstrated at-Hiroshima and Nagasaki.
I think there is 24 general _ agreement on that.
-25 The' chairman of the -- the current chairman of the t
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1 UNSCEAR, a, scientific committee, reviewed the committee's
[
()
2 most recent reports, including the 1994 report that included 3
adaptive responses to radiation of cells and organisms, and f
4 said that although these have been demonstrated, it is still 5_
premature to conclude that small does of radiation have a 6-protective effect.
And which has been observed clearly in i
7 laboratory experiments.
8 How, it is true that this effect-has not been t
l 9
-demonstrated below half'a rad, and so when Shelly Wolff gave a
10 his paper on adaptive responses, on the next page, he
-it discusses that, and says that -- that two centigrade clearly J
12 does this and he said, but for very low doses, below half a_
)
13
' rad, it is not been seen.
And so Elizabeth Cardis of the 14 International Agency on Research in Cancer, IARC, wondering
(
15 how an adaptive response mechanism could be observed in 16 laboratory experiments when one rem or one rad would only r
17
-produce a -- an effect in a cell every two years.
18 Well, that question could be easily answered, t
19 becaus". inter-cellular signalling has been well 20 demonstrated, and so if -- if 1/750th of all cells gets a 21 photon every_-- every day, this still leaves us with over 10 22
-to the 11th cells every day that are receiving radiation.
I t
23 So-it is not necessary for a cell to actually to be r.ffected I
24 by the direct gamma ray, since there are many neighbors that j
25 are than,_that can, and inter-cellular signalling occurs.
3 ANN RILEY & ASSOCIATES, LTD.
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So that is any question to answer.
()
2 Any rate, obviously, too much time will be spent 3
if-I went through the whole summary, but I certainly urge 4 -.you to do that.
I think we all agree, Dr. Yaniv, who was 5
also at the conference, we both agree that this is an 6
excellent summary that Ann McLachlan.
She also pointed out 7
that additional measurements, many measurs snts have been 8-made.in the past that show neutron activation, and the most-9 recent ones are being done in Germany on the nickel in some
- 10 rain gutters, and based on the nickel 63 content, which is
'11
-- which can be formed only by neutron activation.
-12 So that the discarding of the neutron effect that 13 was done in the revision of the T-65 P dosimetry, which was 14 put in effect in 1965, but in 1986, 21 years later, it was
()
15 revised, dispensing with almost all of the neutron radiation 1
16 in Hiroshima.
The argument is -- deals only with Hiroshima,
-17 becaur that was a one of a kind bomb where two uranium 18
-masses were fired and formed a critical mass.
That's the 19 only bomb.
20 And this was simulated in the desert, in Nevada, 21 and on the basis of-that simulation, the T-65 dosimetry in 22-1965 was established.
But arguments were made that the air 23 is very dry in Nevada, and there was some -- some shielding 24 by the container,- that wasn't exactly duplicated in the bomb 25 and, for that reason, a priori, without any new data, new O
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14 j
.1 puctulates.were -- were_ assumed and fed into the large new 2
computer-at Livermore and that is how the DS-86 dosimetry-3-
arose.
t 4
Well, it is very important, because if you ascribe f
5-all the radiation damage to the gamma rays, then, obviously, 6
they have a much greater impact on health effects.
- And, l
7 indeed, as I go through, I will show the original slope of 1
8 the high dose points that had about a one percent per gray i
t 9-incidence of cancer, but by doing away with the neutron 7
10 radiation, which, of course, has an RVE between 10 and 20, 111 this jumped up to a 5 percent.
So this whole revision is l
12 now being questioned and it is admitted by even the 13 strongest proponents, Pierce and Preston, of the revised 14 asymmetry, that there will be a change.
And they say that 15 this will not be much more than 10 to 12 percent.
Actually, it is about 30 to 40 percent, but that is not the real issue, because we multiply that 30 to 40 4.
18 percent by 10 to 20 for the RVE.
So it-makes an enormous 19 difference, de would essentially, in fact, as the -- the 20 ones who deve'.oped the DS-86 said, that if-this neutron 21 radiation is demonstrated, that, indeed, it looks as-through i
I 22 the T-65 D dosimetry would be, by accident,-almost correct.
23 So that is a greatLissue for discussion.
l 24
,There was some stressing that research in Russia, 25 particularly in the Mayak workers and the Techna River, that
)
~
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15 i
1-
-- which were subject to exposure by -- by contamination of 2
their. villages by -- by the dumping of radiation into the 3
river, that this would be very helpful.
In fact, I will l
?
4 present data, some data that has already been published on 5
that group.
j 6
Well, at-the -- at the end, it -- it -- let's see.
7 We have radiation control, and the difficulty i
0; between showing the risk and the actual regulatory control, 9
and there's a paper-by Dr. Paperiello, who will be here at 10-eleven, pointing out his view.
As you know, he's the.
11-l Director of HMSS.
And the session was concluded by 12 Commissioner Greta Dicus, who introduced the speakers, heads 13 of the the chairmen of the different sessions, and 14 thanked them for their~ clear presentation in summarizing, i
15 Well, where do we stand on all this?
Well, in the 16 summary it mentions that my views are that it's the 17 biological system in our body that controls an enormous i
18-number of alterations of DNA and mutations very effectively, 19 and I would like to go into that with the first slide.
20 This is reversed.
It should be molecular biology,
-21 epidemiology,.and the demise of the linear no-threshold 22 hypothesis.
See if we can get that in better focus.
l 23 The reason why molecular biology comes first is 24 because-it~ deals with the central problem as. viewed by NCRP.
- 25 In its rummary'in Report 121 on LNT and of course the l
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collective dose, which is dependent upon it, they state that
()
2 no human data proves or even provides direct support for the i
3 concept of collective dose with the implicit uncertainties i
4 that are involved in LNT there.
The best that can be said 5-is that most: studies do not provide quantitative data that l
6 with statistical significance contradict the concept of i
7 collective dose.
8 And then the summary goes on to say that i
9 ultimately the confidence in the linear no-threshold i
10 response, confidence in LNT, is based on our understanding 11 of'the basic mechanisms involved, and that's why I wanted to 12; deal with the molecular biology first, because they admit-l 13 that there is some statistically significant data that 14 contradicts LNT.
But they still cling to it because of this
(
)
15 understanding of the basic mechanism, that cancer could 16 result from the passage of a singir charged particle, 17 causing damage to'DNA that can be expressed as a mutation or 18 small deletion.
19 Well, a deletion, we're defining any mis-or 20 unrepaired DNA alteration as a mutation.
It is a result of 21 this type of reasoning that LNT cannot be_ excluded.
It is this presumption based on biophysical concepts which 23
=provides a basis for the use of collective dose in radiation 24 protection activities.. Now'this is November '95, so it's 25 just-about two years ago.
It's a. fairly current, I think, h
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accurate statement of their position.
2 And this is just a diagram that shows the ionizing 3
path that produces free radicals which are largely 4
responsible for DNA alterations here demonstrated as a 5
double-strand break.
Now this is an important concept, 6
because double-strand breaks, defined as a break in opposing 7
strands that are within five bases of each other, are more 8
difficult to repair than point mutations.
And-in fact 2 9
percent-of the DNA alterations produced by low-LET radiation 10 are of this nature, 2 percent, 2 out of 100.
11 And the argument goes that we've been engaged in 12 is that the random free-radical alterations produced by DNA 13 will only rarely produce a double-strand break, because it's 14 a random as compared to a focused track of ionizing 15 radiation, and when a cell has 12 billion bases in its two 16 chromosomes -- in its pairs of chromosomes -- obviously the 17 chance of getting opposing double-strand break at random is 18 very small, whereas this is 2 percent.
19 Now even double-strand breaks, by the way, 20 although they are relatively difficult to repair, most of 21 them are repaired.
It turns out that between 90 and 99 22 percent of these double-strand breaks are indeed repaired, 23 which is pretty good if you have proofreading when you don't 24 have a guide on the opposite str.nd.
So that in our 25 calculations we have given the upper limits of difficulty of O
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1 repair to this double-strand break that is 10 percent, i
()
2' saying that only 90 percent of these are repaired, 10 1
3 percent are unrepaired, or_we call them a mutation.
l 4
Now, this is a statement by Bruce Alberts, who i
15 discovered the oncogene, that is, the gene that if it's l
I 6
turned on, if it's altered,.will actually promote 7
malignancy, and this is a quote of his, that in a lifetime-8 that a single mutation is not enough to cause cancer, 9
because in a lifetime every single gene -- and what he means 10 here11s every single class of gene, about 75,000 of them --
11 so he said that these 75,000 genes, every one of them in'the 12 body in some cells somewhere is likely to have undergone f
13 mutation about 10 billion separate times.
And this is only 14 due to the accuracy of-repair of normal cell division.
And
()
15 a free radical is about three orders.of magnitude greater, f
16-So only on the_ basis.of normal division there is a -- it is g
17 very. accurately -- defects are very accurately repaired so i
18-that-only one in -- I think~it's one-in a billion of these 19 separations results in a mutation.
20 So, that being the case, evidently the survival of
-21.
m.amals must. depend on someLform of double or more than 22 double insurance in the mechanisms that' protect us from
- being' overrun by mutant clones of cells that have a selective-advantage over our healthy, normal cells.
If a i
25 single mutation in some particular gene were enough to 1
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1-convert a typical healthy cell into a cancer cell, we would l
2
-not be_ viable organisms.
In other words, the fact that we 3
live on the average now to about 70 years is testimony to 4
the effectiveness of this system, this biosystem that j
5 controls DNA damage so that the number of mutations are
[
6 kept -- that are persistent are kept to a viable number.
7-And what is this biosystem?
This is an outlitie of 8
the significant damage that is produced to DNA by free 9-radicals.
Every cell has about 10 to the 10th free radicals 10 produced in-it every day.
And of that 10 to the 10th, about l
11
_one percent are close enough to the DNA that they're in a f
12 position to actually react with DNA and alter it.
These
-13 free radicals are extremely damaging and change the chemical 14 nature of anything that they run into.
So we have 10 to the 15 8th free radicals that are in a position to damage our DNA.
16 If you can read that, those are -- well, the antioxidants,-
17
-lutathione, a superoxide, dismutase, catalase, peroxidase.
18 There's a host of antioxidants.
We've heard a 19 good deal about antioxidants.
And I've put them in the --
20 as a function that prevents these radicals from producing 21-DNA alterations.
And about 99 percent of these free s
22 radicals that are=in.a position to attack DNA are prevented i
23 by_these antioxidants.
So that we wind up with about a
- 24' million alterations to DNA by free radicals and much less by 25-DNA replication-and thermal every day in every cell, events lh ANN'RILEY & ASSOCIATES, LTD.
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per cell per day.
That's a million.
()
2 Now what they say about these point mutations is 3
quite correct, that is, the advocates of the relative 4
unimportance of free radicals and the importance of 5
radiation, namely, that these are relatively easily fixed, 6
so that only one in 10,000 of these remain as mis-or 7
unrepaired DNA alterations, as actual mutations.
Whereas 8
remember only one in ten of the double-strand breaks remain.
9 So there's a factor here of 1,000 to 1 advantage over the 10 significance of a double-strand break versus these point 11 mutations.
But included in these 100 that are unrepaired 12 are 25 double-strand breaks.
In other words, even though 13 the odds -- because there's a steady-state pool of about 14 30,000 DNA alterations.
()
15 Experiments have been done in animals.
At first 16 they thought there were a half a million steady-state 17 alterations.
Then the technique was refined.
It came down 18 to about 120,000 DNA alterations, steady-state in the cell.
19 Now what that means is that we have DNA alterations, these 20 alterations, that are being formed by free radicals, but the 21 repair system is getting rid of them.
So that what you have 22 is a compartmental analysis in which you have a residual of 23 30,000 alterations in a cell at any one time, as opposed to 24 the million that are formed, 25 Now the reason for this is that the repair time on O-ANN RILEY & ASSOCIATES, LTD.
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1 the average is about a half-hour.
Some of them are 10 or 15
()
2 minutes.
Some of them are an hour.
But a half-hour 3
estimate for the repair time of these alterations is a 4
middle ground that's probably a best compromise for 5
If you have a repair time of a half-hour, a t 6
one-half of a half-hour, that means the turnover is about 45 7
minutes.
So if you have 30,000 DNA alterations and it turns 8
over every 45 minutes, that means that in a day you would 9
have about 32 tim's whatever's in that compartment, and that 10 brings you to 960,000, and that's the basis for the million.
11 The 30,000 is the lowest figure that has been obtained to 12 date by measurement of these oxyadducts in the urine and in 13 humans.
So using the lowest value it comes out to a million 14 a day.
()
15 Now when we have a repair and we have 25 16 double-strand breaks left here and another 75, these are not 17 persistent.
These in turn are largely removed by apoptosis, 18 by necrosis, by cell differentiation.
Once the stem cell 19 differentiates, it's not going to replicate anymore, and 20 aleo by the immune response.
So we have these three classes 21 of agents -- the prevention step, which reduces the possible 22 damage from 10 million to 1 million; repair, which reduces 23 it from 1 million to 100; and finally the removal system 24 that reduces the 100 to 1.
25 And it was about one persistent mutation is in
(
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rough agteement with the tens of thousands that are seen j }
2 at -- in older animals, So this would be in_a lifetime 3
would amount to about 25,550 pers4. tent mutations per cell.
4 Now we're talking of course in the stem ce'.ls that 5
perpetuate themselves because the cells as differentiated 6
cells die and of course we don't have -- if -- about 100 --
i 7
about 100 divi + :nn of differentiated cells occur in a 8
-lifetime, and so over 70 years that would be let's say every i
9 7,
8 months on the average.
Of course-aome cells and-the 1
10 brain don't do that, other cells are much more rapid, 11.
gastrointestinal tracts and in the bone marrow, but on the-12 average then about every eight months whatever mutations 13 have persisted in that cell will be lost.
14 CHAIRMAN GARRICK:
Dr. Pollycove, you indicate
()
15 that these estimates are based on data in the literature.
16 Over what time span are we talking abcut as far as the data 17 base is concerned?
?
18 DR. POLLYCOVE:
Well, I would say it's the 19.
molecular biology that grew very rapidly in the late 20 seventies and early eighties, and as far as the steady-state 21 measurements, those are relatively recent, in the nineties, 22 the steady-state compartment.
23 One of the best researchers in this field, not 24 only Bruce _Ames and Ken Beckman, it was their data that --
25 recent data of 30,000 steady state that I'm using, because O'
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that'0 the lowest.
Previous estimates were 120,000 steady
(~T i
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2 state, 500,000 steady state, and those gave rise to such i
3 great numbers that the importance of antioxidants 4
disappeared.
70 other words, if you had 500,000 instead of 5
30,000, this would be well 0.5 times 10 to the 8th, which 6
not much effec; of antioxidants.
So those' earlier 7
measurements were not made in oxygen-free environments and 8
were not made with the free iron ions removed with chelating 9
agents.
So this low number of 30,000 was obtained by doing 10 the analysis in an oxygen-free environment and scrubbing all 11 of the iron ions with chelates.
So that data is very 12 recent.
The 30,000 was just done this year.
13 CHAIRMAN GARRICK:
Thank you.
14 DR. POLLYCOVE:
And that's on a personal 15 communication.
It's going to be published by Ames and 16 Beckman.
17 All right.
Now what does low-dose radiation do to 18 the system?
An UNSCEAR in 1994 documented that antioxidants 19 are increased by low-dose radiation, that repair is 20 increased by low-dose radiation, and removal is increased by 21 low-dose radiation.
And I'll show you some examples of 22 that.
And then you say well, if they demonstrated all of 23 thtr i., how can they still say that these adaptive responses 24 are not aufficient to change the linear no-threshold 25 hypothesis?
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Court t. porters 1250 I Street, N.W.,
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i Very simply.
They Apply these improvemonts of-
/~~
i 2
prevention repair and removal only to the radiation damage
\\J 3
produced by low-dose radiation, not-this enormous background 4
that we've been talking about due to free radicals.
So they 5
ignore this background because they say well, they're so 6
easily repaired that it doesn't make much difference, what
-7 really counts are the double-strand breaks, and so they 8
apply all of tneir thinking to only radiation damage.
- Well, 9
as long as you ignore this biosystem that keeps us alive, 10 what they say is absolutely true, as we'll see as we go 11 through the calculations.
12 We'll see another slide that shows what happens 13 with a hypothetical increase of response, the total response 14 of these three systems of only 20 percent to increasing
- '( j) t 15 background radiation tenfold.
There are many places in the 16 world where people have lived for many generations in a 17 background of not one-tenth of a rem per year but 1 18 centigray per year.
And the reports from these areas all 19 uniformly stata that these people have less cancer and live 20 longer.
21 Now you say well, if that's the case, why would 22 there be any controversy?
Well, this data said well, this 23 isn't done under case control studies.
The public health 24-records are very poor in these areas of the world, and there 25 are many confounding factors that have not been determined, i
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and so we can't accept any of that data.
So that's why that 7_.,
i 2
cortroversy occurs.
But at any rate, being subject to a NJ 3
d of I r per year is nct above what occurs in many 4
'-n.
a t he world:
Brazil, India, China.
5
,o let us look then at some of these responses 6
thas THEa 4R has documented.
This is a study that was done 7
in Japan, and I'll read the ceiling that says antioxidant 8-SOD and lipid peroxide response to age and radiation, rat 9
brain cortex.
Now I will provide you with hard copy of 10 these slides, because many of these are not included in ny 11 address which you have in front of you of molecular biology 12 and so forth.
13 This is very interesting.
This was done with a 14 rat brain cortex, and these green triangles which are so n
(_)
15 inconspicuous are the superoxide dysmutase level in a 16 seven-weex-old rat -- there we are -- that fortunately is 17 still on the screen -- and this is the lipid peroxidase 18 concentration in the brain of this seven-week-old rat.
19 Now lipid peroxidase is a product of damage to the 20 cel..tlar membrane by free radicals.
So you have this-21 oxidative result of lipid peroxidase.
So this gives you an 22 idea of the damage that is done by the free radicals.
And 23 as you can see, the 65-week-old rat has less antioxidant 24 superoxidase dysmutase than the seven-week-old rat, and the 25 91-week-old rat has even less.
That's pretty much in line ANN RILEY & ASSOCIATES, LTD.
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11 with-our findingsfin humans,-too, and other animals, that
.(y J2
- these repair processes gradually decline with age..
.3.
When the rats received.50,-a half a gray,.of 4.
external: radiation, the 65 week old rat had the superoxide
-5 dysmutase antioxidant rose markedly by about 30 percent, 6;
.more thanl30 percent, from:90 to 120, well above what the 7 7
week old rat has under steady state condition and no 8
radiation.
9 Even the 91 week old rat managed to get up to the 10
- 7. Week old level'about.
11 Conversely, you see that as the antioxidant goes
-12 up the damage produced by the free radicals goes down and 13
.then at high doses as the antioxidant diminishes the damage, 1
14 the lipid peroxidase increases.
- ()
15 MR. EkIRhURST:
Excuse me, could I ask --
16 DR. POLLYCOVE:
Sure.
Absolutely.
17 MR. FAIRHURST:
Presumably these doses are
'18 significantly above background, so that is a negligible 3,9 -
consideration --
20 DR.'POLLYCOVE:
Pardon?
21' MR. FAIRHURST:
The doses that you are talking 22-about to the rats, presumably they are sufficiently so-high 23 compared that background effects are noLconcern.
24L DR. POLLYCOVE:
That's right, that's right.
25' Background, you-see--- viewed this way background also has a
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27 11 ;
_ stimulant effect, but very little.
What we are talking
_- 2 about istone-tenth low LET now.
We'are neglecting radon 3
-which is localized in the? lungs and the equivalent whole 4'
. bod / dose _is just an artifact.
S
-What the rats are exposed to and we are exposed to 6_-
every day is_one 365th -- well, it's about an MR -- well, 7
no, it's'less than an MR.
It's a third of an MR per day-for 8
background, so that when we give 25 or 50 we can say that
'9-then -- and this is what the levels are at this background
'10 -
-level of the 7 week old,_the 65 week and the 90 one and tue 11 same thing for the damage.
12-You see, the damage is least in the 7 week old.
13 Now the repair is very important and although I 14 couldn't find a good figure for showing the boost of repair 16 in-UNSCEAR, they all admit that it ic' stimulated because I
-16 when the animal is subject to high doses the amount of 17 damage that-occurs subsequently is much less, and the same
'18 can be'-- and also as far if you use death as a criterion, 19~
.so there is no question.and they state flatly, and you will 20 see their quote in my paper, that there is no question that 21_
repair is stimulating.
22:
Now this is to show you the importance of repair.
23
- We_-have just seen the importance of the antioxidants.
This is a beautiful study that was done at Johns
_2 4 _
25 Hopkins for"the Dermatology Department.
At Dermatology they 7-f ANN RILEY & ASSOCIATSS, LTD.
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j 28 1:
!had casesLdf 20 and 30 year o1~ds with basal cell carcinoma.
2
!Now-this is--quite rare in that age group:-- very' common!and1 3
- almost universal when'you get to-be-60:and-70, You get:
4
.these little basals and you be sure to get them-removed.
5' They^ don't metastasize but-they are malignant.
6 So they have these young individuals with these 7
basal cells and so they devised a very -- and I won't go 8
into it-because that will take more time -- but a very 9
interesting way of taking the lymphocytes-from these
- 10 patients, normal controls and these patients, and analyzing
- 11
[it for-its ability to repair damaged DNA, and they were able 12 to say what percentage of the damaged DNA was repaired by 13 the lymphocytes, so you can take a blood sample.
I would 14 like to have that tcst.done on myself actually -- and 40
()
15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> later you can' read it out and it tells you what 16 percentage of the damaged DNA wan repaired.
17 It has to do with this chloramphenicol amino 18 transferase activity, this enzyme.
This is produced in 19 these resistant bacteria and we don't have that unless we 20 become resistant to chloramphenicol.
I 21-At any rate, here we see that in the normal' 22-controls the activity is 87.5 percent, quite high, in-23 adults.
Of course, if you took 10 year olds it would be 24
~ even-higher, and that is in youth, and in middle age it 25-
~ drops off to about 78 percent, and in the 50 to 60 year old ANN RILEY & ASSOCIATES, LTD.
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- m,
e,
.e a
n
--au e
e.
r-,-
,,s v
~r-~p-
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- 4 :^
11 grouplitLdrops'offLto about-70Lpercent.-
i (2
Well,<when they took=ic'--ithese patients with 3J basal!' cell carcinoma -in: their 20s and 30s -- - they found-out -
c 4
L4;
- that.they..had-the same level as;thej50~and 60 year olds,-
l LS-Twhere itibegins to be'quite-common,-so it shows how one of:
i6:
L these f actors, :the DNA repair,- is _very.important to prevent
-7 cancer,_as is the antioxidants, as is-the immune system,;so 8-
-all of these.-- it's a complex _ system, a DNA damage control.
i c9
.biosystem that'is able to take care of these mutations.
(10-Now here is the immune system.
This is by e11:
Makinodan & James, 1990 -- this is takenrright out' of the j
12 UNSCEAR report.-
13 Again you see that if.you call the basal immune-14' response to sheep red blood cells,--mouse reaction to sheep
- 151
. red blood cells, and call that 100' percent that it goes up
~
16
.to about 180-percent in vitro when you just do it in a test.
r 17 tube and.then it drops very rapidly.
By the time to get=to 18-
- one gray it's dropped off to only 30_ percent of baseline.
19 This is a different scale.
This represents the 20
.end of this. _This is-2. gray, So you see the same response.
21 in vivo,- in the living-mouse,Lbut it doesn't-go quite as 22'
-high.
-It:only_goes up-40 percent, but it'is much more'-
23 Jresistant to radiation-damage.
At'one gray--
when you_do
'24-it-in!the' test-tube, it's down to 50 percent -- at one-gray, 25
-here;.it's probably about 80-to_90. percent, so it's quite d
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resistantias compared, and'this is typical.
/['\\1 2
If you;have.a whole system working.for you,
- \\,)?
?
~
3-3ignalling and' hormonal; f actors and sonforth, = it's: mucht more 4
-of;a homeostatic system.than ifLyou do it in isolated-test;
-5=
tubes.-
i 6
=At any rate, this. clearly demonstrates-the low 7-Ldoce stimulatory effect;and the high dose damage to the 8
cell._
9
-Not it is not because the-cell has an eitormous 10' number of mutations.
It's not the mutations produced by the 11 1 l radiation ~but by the effect that all of this ionization has 12-
- on all of-the functions of the cell including its' ability to 13 repair DNA;and take care of that, so what is important and
- 14-what was emphasized by Mike Bishop is it's this biosystem
()
15 that keeps us alive, and the ef fects that ' radiation produces 16
- are due tx) the effects it has on the system, not on the
-17~
number of mutations that are produced, which has been the
'18 exclusive focus on the radiation protection community 19 because this was very readily observed in the 1950s and soon 20 after the structure of DNA was elucidated, and~they have 21-just maintained that view.
It hasLpersisted for 40 years.
22-Now this-was-done in humans to show the effect~of:
23 low' dose-radiation.
You'see, these patients, the standard 24-therapy for this non-Hodgkins lymphoma is you give high dose 25
-radiation to shrink.the tumors and then you give ll ANN..RILEY & ASSOCIATES, LTD.
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'11 Lchemotherapy_to_ keep.the recurrencefdown,cand prevent 2-
- formation of1 new tunors - This-is=the standard therapy for:
23; "non-Hodgkins.lymphoma',-la-very difficult disease.
4L IJthink the most notable recent casualty was 5-
- Jackie Kennedy and'it is far-different than Hodgkins 16
-lymphoma,_which,is 95_ percent curable,-but-non-Hodgkins-7 lymphoma -- here isfthe survival of_the patients whofdid not 8
receive---low dose radiation, but just with high dose 9L radiation and chemotherapy.
At the end of three-four years,,
1 10 :
there was about a 36 percent survival -- whereas those who lli received total body irradiation or-half body _ irradiation of 12 only 10 centigray three _ times a week -
now we are talking 13-about 30 centigray a week for five weeks over the total-dose 14_
_of 150 centigray in;these small split doses, their (O
,p 15 survival -- 90 percent at six years.
Remarkable.
16-In fact, the next slide that I have will show what 17 happened to a tumor in the head -- this is a CT scan, and 18 here we have on August the 1st this large tumor in the top 19 of the nacal cavity, the base of the brain, and.six weeks 20 later, gone, and there was no radiation at all in this area.
21 Inffact, this was a patient.who only had half body 1
'22 radiation.
They found out-it didn't make-any difference
_ hether you irradiated the whole body or half body because 231 w
'24
,the main thing was to get the liver _ and: the spleen -ane *.he 25-
- lymphatics in this thoracic area.
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So with no diation, no chemotherapy-this
(',s 2
disappeared as the patie " received this very low dose of j
~
3-10R between the superster: 11 notch and the xiphoid to a 4
cumulative dose of 150, 5
They have a good stimulator because their immune 6
system has been stimulated and is -- and is killing the 7
lymphoma.
8 All right.
So now let's look at what happens if if we assume -- now, this is all assuming.
Assuming that 9
10 the cumulative effect of stimulating the anti-oxidants, the 11 DNA repair enzymes and the many mecnanisms that get rid of 12 mutations, if all of them working together at 10 times 13 background are stimulated to an overall 20 percent increase.
14 Oh, by the way, I neglected a very important --
O)
(_
15 there.
And I am sure you didn't notice it.
Well, probably 16 some of you sharp-eyed did.
This, in parenthesis, is the 17 fraction of metabolic DNA damage from low LET background, 18 100 mr per year radiation DNA damage.
19 Now, the amount of damage produced by radiation is 20 taken from what is well accepted in the radiation literature 21 by John Ward, who is the -- recognized as, if not the most 22
-- certainly in the United States, the most important-23 authority on radiation damage.
He is now editor of 24
" Radiation Research."
And using his data, that one
-25 centigray of energy absorbed by tissue will produce 20 DNA
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1 alterations in each cell.
And of those 20, as I said i )
2 before, 2 percent are double strand breaks.
And since the 3
other -- the other 98 percent are easily repaired, compared 4
to the 2 percent, essentially, this amount of DNA damage is 5
determined correctly, as they say, by the double strand 6
breaks,=because the 98 percent, all 1 is 10,000 is repaired, 7
so they really don't contribute much.
8 But the double strand breaks do, and when you take 9
that into account, you find out that the fraction of the 10 metabolic damage, that is the number of DNA alterations by 11 free radicals and the other factors, DNA replication and 12 thermal, that the damage produced by 100 mr per year, as,our 13 background, is 5 -- about 5 times 10 to the minus 9th of le this, 5 times 10 to the minus 9th.
O(_,/
15 When we get to the mutations, since there are more 16 double strand breaks here, it drops down to the 10 to the 17 7th.
18 So, in other words, in 100,000 cells, one would 19 have one -- one, because that would make it 10 to the 5th if 20 we had one -- would have 100,000 cells, you would have one 21 mutation from radiation, and you would have 10 to the 7th 22 mutations from free radicals.
And, of course, this ratio is 23 maintained because the removal mechanism doesn't distinguish i
24 between one mutation and another, and so it drops down, this 25 one -- and a 10 to the minus 7.
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34-1 So the persisting mutations, if you have 10 to the
,m
'E 2
7th cells, you would have one due to radiation, and you have (d
3 10 to tne 7th due to free radicals.
So that very important 4
part, I omitted.
5 Okay.
So now what happens if we have a tenfold 6
increase in background and a 20 percent stimulation, which 7
is well within the data shown in UNSCEAR '94, a 20 percent 8
stimulation overall.
You see~what we have here is 7 percent 9
here, and 7 percent here and 7 percent here, and you say, 10 well, if you have 7 tP ee times, it becomes 21, but, no, 11 because this is coming down, it actually comes out to 20, 12 the overall effect.
13 Okay.
So our 10 to.the 8th, instead of going down 14 to the 10 to the 6th, would go down, with a 7 percent O(_,)
15 improvement, down to 9.3 times 10 to the 5th, instead of 10 16 to the 6th, a little decrease here, and then with a hundred 17
-- with 7 percent boost'in repair, we would bring this down 18 to 86.
Remember it used to 100.
And, finally, with another 19 7 percent stimulation here, it brings it down to 8/10ths, 20 that's our 20 percent overall stimulation from background.
21 Well, what happens to the radiation damage?
And 22 this is important, because the -- their statement that 23 nothing is absolute, this is in UNSCEAR, they say nothing is 24 absolute.
Sure, you are going to improve the system, but
-25 you are still going to have residual damage, i.e.,
residual
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radiation damage, and, indeed, that is true, s
.(b) 2 The radiation damage, instead of being 10 to the 3
minus _7th, it actually, because this has come down so far, 4
is now 10 to the minus 6th of the metabolic damage.
And 5
when you calculate it out, instead of the radiction damage 6
going up tenfold, which it would do-it if were linear, but 7
because of the 20 percent stimulation, it cnly goes up 8
eight-fold, so it quite true that the repair is not absolute 9
and that there is still a good deal of radiation damage.
In 10 other words, their statement is absolutely correct.
11 But one has to put it in perspective with the 12 damage that occurs normally by metabolism.
So that the low 13 dose effect is not that it reduces radiation damage, which 14 it does a little bit, I mean, instead of going up tenfold, A(_)
15 it goes up eight-fold, but the fact that it goes -- that you 16 have this 20 percent of this enormous background, so that 17 you wind up with 8/10ths of a mutation per cell, instead of 18 one, so you -- and it is this type of effect that has people 19 dying at 90 instead of dying at 75, or having less cancer 20 than at high -- at high background than you do at normal 21 background, 22 So this is the, really, is the heart of the story 23 that low does improve the overall biosystem control of DNA 24 damage and gives rise to these beneficial effects, not 25 because they reduce the radiation damage, far from it, there
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is more radiation damage than there was before, no question f;
2 a'cout that.
U 3-Well, let's see what-some of the data.
These 4
villagers along Mayak River and so forth, this was reported 5
out in 1994.
I have forgotten the name of the Polish 6
investigators, but it is cited by Javarowski,'who is a 7
former chairman of UNSCEAR in -- oh, here it is.
Here is 8
the -- we can focus this.
It's -- there we are.
Kostyuchko 9
V.A. Kreslin L/U in the " Science Toth1 Environment," pages 10
-- I have got that -- Volume 142, it begins_on page 119, 11 1994, and it is cited by Javarowski.
12 So what they found is_that these controls who were 13 subjected to background were used as a 100 percent standard 14 cancer mortality and -- of one.
And the ones who received A
i
).
15 twelve 120 miliseiverts, or 12, here I have rem, or 12 rem, s
16 the same thing, their cancer mortality was 61 percent of the 17 controls.
And those who received the cumulative dose of 50 18 rem, 500 miliseiverts, the incident of cancer mortality in 19 that group was 72 percent of the controls.
20 In Japan, they have been following the survival of 21 the -- of the -- those who were survivors and exposed to 22 A-bomb radiation, male and female, versus the unexposed 23 population.
And the unexposed population is shown in blue.
24 So that_after about the age of 55 or so, or 60, we see that 25 the unexposed population is dying more rapidly.
This is on
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a logscale, so these differences are quite'large when you
()
2' work them out on the logscale._'Are dying much more rapidly
~
.3 -
than the exposed.
4 You might have seen an article in'" Time" that l
5 showed that this was surprising that the exposed survivors 6
were living longer.-
7 Now, this is data taken from residents of a radium 8
spring, Misasa area, where the-radon is quite high and in-9 the water as well as in the air, and we see that_the control
'10_
area, which was a similar area that.is uncongested and used
-11 for recreation and so forth,.but-not near the springs, were 12-used as a control.
And the one relates to the population at 13 large for Japan.
And, in fact, there is another spring that 14 did not have radon that is very popular and crowded, and I) 15 they actually were a little above this level.
16 Well, you see that-the people in the -- at this 17 high radon concentration area had considerably less, their 18 standardized mortality rate from total cancer was about half 19-of the -- of the population at large, and very -- and 20
. considerably reduced with respect to this other area that'is-21 quiet and not polluted and so forth.
And you can see total 22 cancer, stomach cancer, both male and female, were 23 strikingly -- are strikingly, not were -- are strikingly 24-reduced in this. concentration,lhigh background.
<25 This wasi-- I-quoted that from Kondo in.1993 book 2
I
's.3
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on this subject..
I I
2 And this is Bernard Cohen's data from the V University of Pittsburgh showing that -- oops.
Come on,-
4 fthat's -- okay.
Showing that the -- corrected for smoking, 5
the mortality from lung cancer, compared to baseline 6
mortality, decreases very sigaificantly and progressively as 7
the resident radon level increases from about the average 8
for the country, about 1.5 picograms -- picocuries per.
9 liter, all the way to 6 or 7.
10 Here we see the nuclear shipyard worker study.
'll MR. HORNBERGER:
Dr. Pollycove --
12 DR. POLLYCOVE:
Yes.
13 MR. HORNBERGER:
On that last slide, could you 14 just tell me, what's the EPA action level?
Do you know?
O(,)
15 DR. POLLYCOVE:
Yes, the EPA action level is right 16 here.
There people have to or are supposed to get rid of 17 their radon.
It's right at this level.
And that's because 18 there are relatively few.
You see, it's just at this level 19 you see that the bars get bigger, so this way they would 20 have less of a kickback from the public than if they-picked 21 3, because you see there are a lot of people still here.
22 This is standardized mortality in the shipyard 23 workers as compared to the unbadged workers, and this is the 24 only study I know of that did a very careful study of the 25
'unbadged workers who were performing the same work and so
.,A
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39 11-forth.
So we see very significant-reductions of all causes,
()
2 no statisticalEsignificance here.
This-is.getting to be
.3 prettyfsuggestive because the~95-percent confidence limits 4
doesn't quite get up tolthe mean, but nevertheless there is 5
overlap of the 95-percent confidence level, so that 6
rigorously this decrease in lymphatic and hematopoietic-
'?
cancers is_'also not statistically significant at the
.8 95-percent confidence level.
9 Now I want to emphasize that this data is on ' 1 10
'very closely matched -- 29,000 badged nuclear radiation 11 workers that received more than half -- more than 5 12 milliseiverts cumulative dose, all the way up to more than 13 50, compared to the unbadged workers.
14 And the UNSCEAR comment on this study was that, as
)
15 you-can read it, that since the three groups were identical 16 and they_were doing the same kind of work and the median age 17
.of employment was the same, that the statistically 18 significant decrease in standardized mortality ratio from 19 all causes.cannot be due to the healthy-worker.effect alone, 30 since the nonnuclear workers and-the nuclear workers were 21 similarly selected for employment and were afforded the same 22' health care thereafter.
4 23
'Now that study was never published, and when I 24 asked DOELwhy, they said it wasn't in the contract.
That's 25'
-what-I'was told.
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But this study was.
This study is by Cardis et
['l 2
al., and this study pulled together 95,000 badged employees
%J 3
in three countries in seven different facilities, and they 4
said that there was no increase of cancer from all causes.
5 In fact, their data showed that they didn't do the --
6 analyze the nonbadged workers, they just did an internal 7
comparison of the badged workers, similar to what was done 8
at Rocketdyne.
And the internal comparison did not show --
9 actually it showed a slight decrease only -- using one-sided 10 P values, mind you, only damage; the other didn't count --
31 showed that there was a decrease in cancer mortality even 12 then if you eliminated the lymphatchemopoietic nonchronic 13 lymphocytic leukemias.
They said that on the nonchronic 14 lymphocytic leukemias the trend analysis of the dose (O
,j 15 categories with an estimated P of 0.046 was obtained using 16 computer simulations based on 5,000 samples rather than the 17 normal approximation.
And this is the actual data that they 18 use.
This is taken right out of their chart.
19-In this dose category there were fewer observed 20 deaths than expected.
That was thrown out.
That got rid of 21 60.
In this category there were 1.8 deaths more, so this 22 was kept.
This was less than expected, thrown out.
This is 23 less than expected, chrown out.
This is 1.6 deaths more 24 than-expected, retained.
This is
.7 deaths less than 25 expected, thrown _out.
So that-they wound up with these
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~1.
- yellow ones, D2,.D5, D7,- with 33 deaths of-119.
And they.in-U[~ld
- 2
.theirl statement in their summary abstract they said they did
-:t lan_ analysis ~on 119 deaths.
They did use one-sided-P values, 4
so they got rid.of 86_of those deaths, and wound up with
!i
-only 33.
Now they said that 33 is-inadequate, so they had 6
.to do a 5,000-death simulation, and on that basis they got
- /
this trend.
8 And this is the author's,.IARC, who want to do a-9 new study that will have 600,000 orkers instead of only 10 95,000.
-11:
Now the Canadian fluoroscopy study concluded its 12 analysis of breast carcinoma in women receiving various
-13 amounts of cumulative exposure over a period of several years who were in TB sanitaria-that were repeatedly 14 (f
=15
- fluoroscoped to see how their lungs were collapsed and how-16 therapy was going And they said that the best fit to the 17 data was linear and the risk from exposure to 1 centigray 18 per million women if we just look at let's say 30-year-old, 19 there are very-few, very few in this category, 30-year-olds 20 were 55, 20-year-oldsLabout 90, 40-year-olds less.
This is 21 about an average.
22 The 55, if you got one centigray to your breast, 23 you stood 55 chances in a million would increase your odds
'24 of dying of breast cancer.
And this is the table of data 25 that they.had, and these are the dose ranges,.O to 9 was ANN RILEY & ASSOCIATES, LTD.
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11 fconsidered--the controls.
Most'of~them were around 0, 10 l
1
()
(2?
through'19,--201through 29, and so forth. : Nova Scotia was 3
- aberrantLbecause they did the-fluoroscopy AP with the screen
{
4-in the back_and they had. received-25-times the dose to the.
l 5
breast that the normal PA would-having the low-energy X rays 6
enter-postarially and having the film in front.
At any-7 rate -- and this is their srandardized rate per million 8-person-years for non-Nova Scotia.
We'll_ forget about the 9
high-dose area.-
10 We see that the rate goes down from about 586 per Ell ;
million to 390 per million, back up to 498, still-12 significantly less, and then by the time we get to the 30 tcr 13 39 dose -- 30 to 39 rem or centigray we're back up slightly 14
_above,- not statistically significant, but slightly above
()
- 15 baseline, and even when you go to the 40 to 70, it's.still 16
- hovering around this range, because there's so few cases.
17 But it's clear _from inspection of the table that the rate 28 goes down and-then comes back_up, and-that there's-no.way 19 you can fit that with a linear fit.
20 So Ted Webster, the physicist at Mass.- General 21
' Hospital,'who was not an official. reviewer-but was 22 privileged to see the' data before it was finally published, 23 was upset that they thought'that-the linear _ fit was the best 24.
response.
So he plotted the data..Now when you see an-25; article:in which you have a table and they don't. plot'the O
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results, one should become suspicious, and he was, because rN-2 this-is what it looks like.
([
3.
This is his plot of the data.
The-fact that 4
here's that dip that we talked about at 15 rad,-here it's 5
still-below baseline at 25, and then it's hanging in there 6
slightly above, we mentioned before, and then at the higher 7
dose level at 175 we're up'to considerably elevated.
But 8
there are so few cases that two standard deviations it's 9
still not significantly elevated.
And here of course these 10 are not significantly elevated.
And these points are.all 11 compatible with no risk or less at the 95-percent confidence 12 level.
But this point is not compatible with no effect.
13 The 95-percent confidence level is below the controls.
14 Now the second author of this paper, Jeffrey Howe, A(,)
15 proceeded to revise this study seven years later in 1986, 16 and he revised it.
He said, well, now we have more data --
17 it's true, there's another seven years of follow-up on 18 these.
19 Now these were done in the '30s so we have now 20
'30s and '40s -- we have follow-up now 40, 50 years.
It's 21 as long or longer than the follow-up in the Rocketdyne 22 study.
23 In-his introduction he says that the breast tissue 24 doses of current concern are primarily those associated with 25 routine diagnostic procedures, particularly mammographic
,m
(
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screening,_and he's right.. That's about:2-milleselverts.
()
2J Such doses are substantially lower than the average breast 3
tissue dose. received by women'~in the atomic bomb and redical 4
cohort studies.
Now that 's true.-
~5 But this is not true -
"This necessitates the
.i 6-covelopment of mathematical model; *or risk projection based r
7-on observations and high dose studies" -- remember, he is an 8
author of this low dose study that clearly demonstrated this 9-
-very beneficial effect, reduction of mortality from breast 10 cancer to two-thirds, if you remember.
That's two-thirds.
11 That's a one-third drop here -- two-thirds of the controls.
12 Now this is a -- it's either a complete dioaelief.
13 of-their own data-or it's a_ complete disregard of health of 14 women.
15 "So this necessitates the development of 16 mathematical models for risk projection based on observation 17 of high dose studies.which can then be used to extrapolate 18 to-the low doses."
You saw the type of extrapolation that 19-goes on.
20.
So what did-he.do with his revision?
The first 21 dose category rose from 1 to 50.
He' lumps them all together 22 so you can't see the reduction.
23--
In the workshop that we had in July, because 12 4 -
.someone brought up breast cancer in the atomic -- although-25 we were supposed'to be talking about molecular biology --
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-there was someone from the NIH that brought up breast cancer
(
)
2=
in the atomic survivors study which showed some, at low 3
doses'some decrease consistent with this,_but they didn't 4
have enough cases, it wasn't statistically significant, but 5
he was talking about that and it really had nothing to do 6
with -- he was talking about the high dose effects of breast 7
cancer, which had nothing to do with actually our topics of 8
discussion, so at that time I thought; well, if we are going 9-to talk about breast cancer I'll bring these up, and I did.
10 Jeffrey Howe was sitting there as a member of the 11 National Academy of Sciences when I went through this.
12 Here is another example of this -- this 1996 study 13 of Pierce, et al., of the latest update of solid cancer 14 deaths in the Japanese lifespan study.
This was referred (A,)
15 to, if you read the Seville notes, that Warren Sinclair said 16 we have demonstrated down to 5 rem -- now who says that we 17 don't have any data to support the linear, no threshold? --
18 although he agreed that nothing below 20 at the conference, 19 but now he was back on the 5 rem, and we'll see how this was 20 derived.
21 The question of the lowest dose at which there is 22 statistically significant excess risk is of interest to 23 some, but that isn't enough to provide these statistically 24 significant, lowest dose which is statistically 25 significant -- even though it.is of interest to some because
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of the_ tendency of the uninformed reader -- how can we put
[~)/
2 that? -- for the failure to find a significant effect to be
\\_
3 equated to no effect.
4 Now he is now thinking for me -- failure to find a 5
significant effect to be equated to no effect -- of course, 6
this is done repeatedly for those studies that show hormetic 7
effect.
They say, oh, no, it's only good at the 90 percent 3
level or it's only good to the 80 percent level, it's not 9
significant, but now when it comes to the " gold standard,"
10 it suddenly doesn't make any difference if it is not 11 significant -- because you might think that there is no 12 effect, just because it's not demonstrated to be 13 significant, and this does not reflect a very cogent 14 approach to inference -- inference about low dose risks.
(3 r,,)
15 So he admits that what he is going to show is an 16 inference and yet Warren Sinclair is saying this is solid 17 data, all right?
We have considered the question of 18 determination of the minimum dose -- DM -- for which a 19 statistically significant dose response when an analysis is 20 restricted in this low dose range up to the lowest dose 21 based on the statistical methods discussed below, and it's 22 very difficult to find out the statistical method that he 23-uses because it is far, far below, many pages and very 24 cryptically alluded to.
25 This 0.05 -- that's 5 centiseiverts -- P equals f~D ANN RILEY.& ASSOCIATES, LTD.
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47 1-two-sided test, all right?
Now what is tested there at 5 f si 2.
centisoivert?
It's very interesting.
(\\I i
3 The statistical methods that he used does not used 4
observed excess solid cancer deaths, but substitutes
-5 estimated excess deaths derived from a model that assumes 6
linearity and this is documented by their own slide at the 7
National Council of Radiation Protection Annual Meeting in L
April of
'96, which was just three months before the paper 9
came out in Radiation Research.
10 This was the data that the authors presented at 11-that annual meeting of NCRP, They gave the dose and the 12 observed deaths, but not these.
Observed deaths, but not 13 observed excess deaths -- this was not shown.
These two 14 columns were not shown.
What was shown was estimated and O(,/
15 this is part of their slide, not my words -
" estimated 16 excess deaths and attributable fraction to excess deaths of 17 the solid tumors.
18 Now you see, if you look at the attributable 19 fraction of solid tumors, you can see it looks very linear.
20 It goes zero, 1,
6, 12 -- it's beautiful -- when it is 21 arrived at using estimated excess deaths.
22 But if you look at the observed, this is the data 23 that came out in the paper, which he didn't want to analyze 24 because you might get the wrong conclusion because it's not 25 significant that there was no effect.
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This is. the data _ from the paper and you see' how n(;L 2
the observed differ from the estimated -- 18, 28 -- and'so 3
the-observed: fraction = attributable you-see shows a negative L4 here, 3 percent, 4 percent, but-now when we get to from 2 to
^
5 5 or 35 centiseivert average between 20 and_50, now they 6
begin to correspond very nicely.- That shows exactly what' 7
happened.
-8 They took a linear fifth to the high dose data, 19.
extrapolated down to the low dose and said, well, where is 10 the lower statistically significant?
'11 MR. FAIRHURST:
Excuse me.
Above 2 seiverts they 12 go down-again --
13 LR. POLLYCOVE:
Two seiverts?
-14 MR. FAIRHURST:
Because of the --
)
15-DR. POLLYCOVE:
Yes, yes.
That is another thing I 16 didn't bother to -- you-are absolutely right.
When you get 17-to high doses it goes down again.
It doesn't continue on a 18 flinear, and so when it is-claimed that above 10 it's linear, 19 that's simply not true because when you get to the high dose 20 range it's no longer linear.
It falls off, so you get sort-21 of a sigmoid thing, down below -- and then off at the high 22 dose.
23' MR. FAIRHURST:
But why does it fall?
24" DR.-POLLYCOVE:
Well, I don't know.
Maybe, you 125' know,rthere's enough. cell killing so-that you don't die r~s
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_ - _, ~
~ _..._-_. _ _ _._ _. _._-. _.
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-of;-- tNe-malignancies.begin1toffall'off.. CertainlyJat a 2 '.
'very high' dose'that happens.
' 3:
I just assume that at high doses that-thei 4
- malignant cells,1which are more. sensitive, they-are more 5
rapidly dividing, that they would be killed and just as high
- I 61 radiation dosel-- of. course much higher ---is used to remove
.7
. malignant cells, so.that may be the explanation.
8 Well, this is th'e analysis which they did not~
9-provide when_you look at the data, and'you see that the
'10 excess deaths at Sr havesa P value of 0.25', but more' telling j
~ !11-
-isuthat the excess deaths here at 15r have a P value of 12
- 0. 5 6. -
ItLis only when you get to 35r that it is e
4 13 statistically significant, so if they were to publish in 14' their paper what is the lowest dose that is statistically
()
15 significant increase of solid tumors, the answer is 35R, not 16 SR, and they didn't want to say that, so he said that-you'd 17-
.just get the wrong impression if we said that the first 18 statistically significant is lower, because they you'd say there's no effect below that.
19-20 So anyway this simple, straightforward analysis of 21 the data was not presented because weLmight get the wrong.
-22 ideaTin our heads.
23' This was worked out very carefully with-Dr. Ludwig
. 2 4.
Feinendegen and myself.
25 Now this is an old slide ~and I-want to show-it ANN RILEY & ASSOCIATES, LTD.
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-1 ibecause-.this was on T65 D dosimetry:inLthe early dayo in the 2
L'60sLand?'70s and even'early1'80s.
13
-_The.high dose data' flops-aroundfrough'y_-like this, l
i (A
not very-good, and'you~can_see you.might say there is a 5-fall off'there,1but'atLany rate the high dose data flops 6
Laround and if you project this, you get_about a one percent 7-risk for a grid,'and nowLit is 5 percentnwith the new DS 86 8
dosimetry that got-rid of.allithe neutrons which would have 9'
a relative biologic effect offl0 to 20, so I thought this
- 10 old slide was of interest; 11 1 Now just a_ conclusion.
This is again another-look 12 at Bernie Cohen's work and how -- and this is the BEIR IV.
13=
_ extrapolation--'for-many orders of magnitude above the uranium i
- 14
'mine workers.
t
()
15 Well, how can you then reconcile this?
16 Well, you can reconcile it very easy by using a 17 mathematical model which is being used, by the way, by --
18 it's terrible to look at, but just to get an idea of1the 19-complexity -
it's use by Suresh.Moolgavkar to give a_ linear 20-
'fifth.
The way he-gets a linear fifth is he doesn't change-l
- . 21 any of-the feedback-and death and repair.
They all stay at 22 a constant level.
There is no change at. low doses, so 23 obviously if.theyLare all fixed then you if-just increase:it L
R2 4 -
-you are going"to get a linear increase, so it looks very 25
' rigorous butLif you keepEall the rate constants constant you 1
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1 are going to_get a proportional: linear effect.
()
2 Now what Ken Bogen did was he said, well, I am not 3
= going to k4ep the rate constant -
I am going to improve l
-4 repair, and he does it by one simple thing -- just apetosis.
f 5
.Actually, the real situation is much more 6
complicated, as I pointed out before.
There are many things i
7
- that are stimulated, not just apetosis, but if you pick up _
i 8
this one thing and get rid of this, then what you wind up 9_
with in this. mathematical model, you get this kind of thing-j 10 which you can, by having the rate constant, it's properly i
31 adjusted, get exactly Bernie's data, and if you want_to just 12 arbitrarily say, which by the way this is far too -- it 13 doesn't correspond to the actual slope which you saw on 14 Dernie's -- this is funny.
l
()
15 I'd tell Ken Bogen he ought to at least use their 16-data.
17 This has an increase of 1.4 already at around 5 18 picoeuries per-liter.
So now if we -- if we go to 5 19 picocuries per liter, you have a very small increase in 20 risk.
They have got -- they have got it already, you know, 21 off the ceiling.
But in any rate.
22 MR. HORNBERGER:
Now, that is starting at zero.
23 DR._POLLYCOVEr What?
Yes.
Yeah.
But, right, 24
-let's'go-back.
25
.MR. HORNBERGER:'-Alsut 20 percent --
1 i
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THE REPORTER:
Use your microphone.
l 2
DR. POLLYCOVE:
Oh, All tight.
'Is that better?
3-MR. HORNBERGER:
He_is talking to me.
4 DR. POLLYCOVE:
See if this is still on. - Is it l
5 working?
Okay.
]
6 Yes.
Well, right.
So we can say that -- right, l
7-that the risk, the increment here.is
.4.
You are quite
{
8
- right,
.4 at 5.
t 9
Now, we will go back.
So let's get an increment 10 of. 4 at 5.
I'm glad you called that to my attention.
11 Oops.
I'll get this-focused-h re.
All right.
.4 at 5, so 12 you can see that it is quite a different slope, like that.
13 But at any rate, whatever it is, you can -- you 14 can then just change the rate constants and knock off the 15 protective effect and you can get back to the high dose 16 state.
In other words, the mathematical models will take
-17 into account low dose stimulation and high dose depression, 18
-but as -- the normal constants are worse on repa.ir than they j
19
.starc off.
And so it is easy to develop mathematical models 20 that can actually incorporate the stimulating effect of low 21-doses and the damaging effect of high doses, that is my only 22
. point.
23 And this=is just very similar to what is shown in 24 a diagram by Luckey -- and, by the way, this is just about 25
_20
---20 centigray.
And this came out, you know, about a V[
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{
1 decade ago.
20 centigray.- And this is the zero equivalent 2
point, which would be a threuhold.
3 Now, of course, if it turns out actually that l
4 there are -- that, indeed, there are beneficial effects, 5
and, of course, in Europe these radon spas are very popular, 6
.there is no reason --
7
[ Laughter.]
i 8
DR. POLLYCOVE:
There is no reason why you can't l
r 9
indulge.
But at any' rate, chis would give a zero equivalent 10 point reasonable threshold, as contrasted with the linear.
l 11-Well, finally, I think this quote is a marvelous 12 one, and I will get it focused here.
By Richard Feynman, 13
-wno is a wonderful teacher as well as marvelous theoretical 14 physicist, is deceased now, got the Nobel Prize for physics 15 in 1965, and it says, "In general, we look for a law by the
[
16 following process:
First, we guess to see what would be
~
17 implied if this law we guessed is right.
And then we 18 compare the result of the computation with nature, with 19 experiment, experience, compare it directly with observation 20 to see it it works."
21 Now, here-is a theoretical physicist and he says,
'22.
look, the final -- the final thing is if-it actually 23
. corresponds to reality.
"If it disagrees with experiment, 24:
--it is wrong." :And that simple statement is the key to 25 science.
"It does not make any difference how beautiful, i
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i 1
54 1-and, of_ course, this a beautiful, simple model, how l
()
2
' beautiful your guess is, it doesn't make any difference how 3
smart you are, who made the guess, what his name is.
If it 4
disagrees with experiment, it is wrong.
That's all there is i
5 to it."
t 6
And I think, you know, it:is just a matter:of
-7 time, because we know of nothing in medicine, or biology, l
8 that is linear.
The most pernicious poisons that are --
9 when you get the dose down low enough, they are either-
[
10 stimulatory or harmless, and this is true for arsenic, this 11 is true for many things, that the FDA rules against.
As 12 Bruce Ames shows, it is present in food, that the essential 13 for life in tract amounts.
14 My own particular area of research was iron
()
]
15 metabolism.
And iron is one of the most reactive, ionic 16 iron is almost like a free radical.
It will react and i
17 combine with anything.
So the body takes good care of the 18 iron that we need for hemoglobin synthesis and for our 19 cytochromes and enzymes, by always having iron kelated and 20 bound to a protein.
It is like a baton that is passed from 21 one hand to another.
It is never allowed to float around 22
. loose.
Even so, very-snall amounts of ionic iron,
" know, 23 even a kelato, nothing is perfect, has a very small amount 24 of iron -- ionic iron-present, but not enough to do any 25 harm.-
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So here is something that is absoittely essential
()
2 to life, iron, that is extremely toxic in ionic form, and, 3
in fact, if you swallowed 100 iron pills at one time, it 4
would undoubtedly. erode your stomach and cause massive 5
gastric bleeding, and, yet, in trace amounts, it is 6
absolutely _ essential.
And this is true of arsenic.
This is 7
true of chromium.-
Elements that are very toxic at high I
8 amounts, but in the proper amount are beneficial.
9-And all the medication we have in medicine is the 10 same way.
At the right does, it will have certain desirable l
31 functions.
You take 10 or 100, or 1,000 times that dose, it 12 will probably -- a 1,000 will probably be lethal for most 13 medications that we take, 14 So we see nothing in medicine or biology that is
()
15 linear. -And as the -- as NCRP very correctly stated,-and 16 this is quoted in my article that you have, that the-LNT is 17 a bio-physical presumption, not a biological one, a 18 bio-physical presumption.
The words that are used by NCRP l
19 to describe LNT are absolutely accurate, and I couldn't have 20 done better myself.
21 Thank you.
22 MR. WYMER:
Thank you very much, Dr. Pollycove, 23 for a stimulating discussion.
24 Are there any responses, linear or otherwise, from I
. 2 5_
the audience? _Any questions, that is?
4
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MR. HORNBERGER:
I take it you don't have very
()
2-strong feelings on this, i
3
[ Laughter. )'
l 4
DR. POLLYCOVE:
Well, I am afraid my tone of voice 5
gives me away.
6 MR. HORNBERGER:
Would you say, to summarize, that i
1 7
the best guess right now, given the data that we have, is
)
8
'that a 20, a threshold of 20 is appropriate for us to --
l
)
9 DR. POLLYCOVE:
1 would-say it is' appropriate, I_
i 10 would say itLis safe. _You know, you -- look, I mean all the 11 data we have, and including the Wingsprend, say we can't see 12 any significant damage below 20.
We can extrapolate and 13 talk IQ's and Randall this and that, but actual observed damage, we don't see.
14
()
15 Now, obviously, you don't want -- you don't want
{
16-to have a threshold right_at your level.
I would be very
'17 happy to for the moment, and give away all the benefits for i.
18 hormesis.
But for the moment, till it is better 19 established, to say, oh, let's go in order of magnitude l
20 down, let's go down ir, and I think that would solve our 4
21 clean-up problems and -- and the normal variation in 22
-backgrcund.
All -- I mean there are very few places in the I
23.
world.where the background is greater than 1r.
24.
And so if we had -- of course, I know th at Dr.
25 Paperiello will_be talking with you, and he would be l
[dL 3_
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delighted with -- for clean-up, for 100 mr, a tenth of that.
/
2 But I think that, in other words, I would be -- well, I k
3 would be very happy to subject myself ir per year, very
-i 4
happy.
I think it would do me good.
l 1
5 MR. WYMER:
Any other questions or comments?
l 6
(No response.)
7 MR. WYMER:
I thank you very much.
8 DR. POLLYCOVE:
You're very welcome.
]
9 MR. WYMER:
For many of us, that was a cuantum
[
10 leap in information.-
11 DR. POLLYCOVE:
Now, as-I say, in the paper there 12.
are just ten slides there, and I was informed by Mr. Larson 13 that you probably would want to have some documentation of l
14-all of it, so I will prepare copies of all the slides and l
15 send them to you.
16 MR. WYMER:
Very good.
Thank you.
17 DR. POLLYCOVE:
Yes.
18 MR. WYMER:
The next speaker on my outline here is 19 Dr. Carl Paperiello.
Is he here-yet?
20 DR. PAPERIELLO:
Yes.
21 CHAIRMAN GARRICK:
I think maybe, Ray, we ought to
[
22 take a break.
We have-a break scheduled in here.
And maybe 23'
.now-is good time to do that.
24-MR. WYMER:-- Okay.. Right.
That is a good idea.
25 CHAIRMAN GARRICK:
Yeah.
So don't we take a 15 t
[\\
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58 1
_ minute break.
Thank you.
2
[ Recess.)
3 MR-WYMER:
Let's stan the proceedings again j
4
'here.
5 Next on the agenda is Dr. Holahan, who's a senior 6
health pNysicist with the Raciation Protection Branch, who l
7 is going to give us sort of an update on things that are l
l 8
going on.
l 9
Please.
110 MR. HOLAHANt
'I-just wanted to open with a 11 cartoon, if you will.
This was published in the Health 12 Physics Newsletter just this month, and it may help f
i 13 summarize many of the things that we've heard this morning.
l 14 I see we've got four different hypothetical curves here f
15' called the lineup, and if you don't mind I'll read to you.
16 At the bottom it says the culprit who put us into risk' looks 17 somewhat like No. 2, but it could have been No. 1 or No -3 18 or No. 4, or to tell you the truth, it might not be any of 19 them at all, or it could have been more than one of them.
20 As Charlie Meinhold, the president of the NCRP, i
21 had prepared in comments for the Wingate meeting, if it were 22 so simple that Bernie Cohen or Warren Sinclair or others 23 were actually 100-percent right, the issue of linear 24 nonthreshold-hypothesis-would in: fact be quite simple.
But 25-the problem, it isn't.
And we're dealing with a situation
+
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where the data is very. strong at 20 centiselverts and
()
2 higher, at least from the epidemiological side.
3 If you talk to folks like John Boice,- formerly l
i 4'
with the NCI, he will tell you that statistical significance j
5 really_doesn't happen until we get to about 35 rem, where 6
we've got risk rates that are about_1.2 or 1.3.
But to be l
7 able to 90 down into the lower dose ranges we have to look
-f 8
at the extrapolation of data, because the number of cancers
! are so few and the number of people that we'd have to look 10
-at are so large.
11 One of the things that had triggered several 12 projects that are ongoing now was the 1994 publication of l
13 UNSCEAR.
The report to the U.N. is only about five pages in 14 length, but it'has two major annexes.
The first annex deals-
}
(
15' with the. epidemiological studies of radiation 16
~ carcinogenesis, and the second one, which Dr. Pollycove 17 talked to you in detail and abstracted information, was 18.
adaptive responses to radiation in cells-and organisms.
19 A problem from my perception with the way this was 20 set up was in the conservation of space.
They tried to make 21
-sure with the annexes they didn't duplicate information.
So 22 what you find is.in some cases something that would be very 23 pro-adaptive response acknowledging that anything_that~might 24--
be counter-to.that was-in Appendix A,- and the information.
25 that was in Appendix A that~might have been very i
)
i O
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pro-carcinogenic effects didn't necessarily address the
()
2 adaptive response.
3 But this was published in August of 1994, and in 4
part in response to that we received a proposal from NCRP in 5
February of '95 to conduct a comprehensive review of the 6
linear nonthreshold hypothesis.
7 I'll just go over a couple of these points very 8
briefly.
What I would like to do is really just give you n 9
status update.
You were briefed ca this I believe about 10 year ago.
But in fact the proposal was for a three-year 11 study.
It was initiated in the August time frame of
'95.
l 12 The committee has met five times to date.
The 13 purpose as you can see here was basically a roassessment of 14 the data, and as I say triggered in part by the UNSCEAR
(
15 report, where they would look at low-dose, approximately 20 16 rem, and approximately 1 r per hour as a dose rate.
17 Nov subsequent to receiving this proposal the 18 staff in the Radiation Protection and Health Effects Branch 19 went back to the council and asked to reiterate a couple of 20 things, that from a regulatory standpoint we are very much 21 interested in doses and dose rates below these.
That is to 22 say, much of the regulation that we're dealing with today 23 are questions of 15 and 25 millirem per year above 24 background, which is clearly orders of magnitude below this 25 dose region right.here.
Similarly when we're talking _about
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dose rates that are 15 and 20 or 30 millirem per year, we're
()
_2 talking something that's very much significantly below this.
3 And when I posed this both to NCRP and later to i
4 the National Research Council and some of the efforts we i
5 had,-you'd almost see people turn gray right there, because f
6 of the lack of data.
We clearly don't have it to date on 7
che epidemiological side, and it'n beyond the envelope, if 8
you will, on cell and molecular biology right now as it 9
exists _today.
I 10 Again the rationale that NCRP provided to us in i
11 taking on this study is as follows:
A couple of the words i
i 12 that I've highlighted here is the fact that LNT is an
-13 assumption, and as an assumption ic is not based in fact to 14 this date.
As a regulatory agency we do use it as a tool
()
15 for managing risk.
We don't use it necessarily to predict 16 on an individual basic what is going to happen.
17 Where ore we today with this project?
A writing 18-team had-been-established.
There are approximately eight 19 members on the committee.
The report's going to have 20 approximately nine sections.
You can see that we're dealing 21 with many of the cellular molecular aspects of this, 22 chromosome-aberrations.
We have several folks doing 23 oncogenic transformation.
Dr. Hall from Columbia's working 24.
on that,-carcinogenic effects not only in laboratory animals 25' but human populations, and in response, as I say, to O
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Appendix B here, adaptive response.
()
2 Now in addition to the individual work that the 3
committee is doing, last year they solicited a call for 4
papers from the scientific community.
That-call was in such 5
journals as the Health Physics Journal, Radiation Research.
6 Approximately 42 individuals have submitted reams of 7
information, either personal correspondence, reprints.
My 8
understanding from the project manager on this project is 1
9 they-have s
-1 linear feet of material that they're 10 trying to Jort through.
And the subcommittee, Scientific 11 Committee 1-6 has been encouraged to actually have a public 4
12 hearing where they'll invite members of the public to come 13 in and address the committee directly.
We believe that this 14 will probably be held in the spring of next year where a
()
- .5 finite group of folks will actually come in and make their 16 case known directly to the committee.
17 -
Based on the literature that's been submitted, 18 based on the presentations that are made to the committee, 19 and based on their own research, we're anticipating right 20 now by the end of next year to have a draft report that will 21 be available for review and' comment by the collaborat!.ng 22-organizations.
23-When I say collaborating organizations, there are 24 40-some organizations that will have a chance to provide 25 comments.on theJdraft report.
NRC is one of those
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1 organizations.
DOE, EPA,.NIST - -the advisory committee had f
()
2 indicated that they were interested in having some outside 3
personnel review the statistics of-the data that was 4
presented there, and they suggested NIST.
Well, NIST is a 5
collaborating organization, and they will have a full chop
[
6 on that.
7 Based on that review cycle, which will take 8
probably anywhere from six months to a year plus votes by 9
the council itself, I would anticipate something, probably 10 tho '99 time frame before we see a final published report, 11 but we should have a draft report as I say probably the end j
12 of next year.
13 In concert with this, we have a second project 14 that we started, an1 this is with the National Research
()
15 Council.
This particular project was intended to be a 16 little more broad-based than just the NCRP review.
It's the 17 biological effects of exposure to ionizing radiation.
It 18 would be report No. VII.
19 Report No.
V, which was published in the December 20
'89 time frame, reviewed much of the dosimetry and the I
21 epidemiological studies that were associated with Hiroshima 22-and Nagasaki in the DS '86 review, and the question that 23 EPA, DOE, and NRC asked, is it time to do a reassessment of 24 that BEIR study-looking at some of the new data that was 25
-available.
l
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Much of'that new data that we're interested in was
(
2 alluded to very briefly this morning.
There are a number of 3
studies ongoing in Russia, both among the population of the 4
Tetru River area, as well as the Mayak production workers.
5-We have additional followup information on the atomic bomb 6
study, the lifespan study, as well as the anticipated 7
changes in the dosimetry that might be associated with i
8 Hiroshima.
9 Similar to what was done with BEIR VI, which was 10 the' radon study in 1994, there was a scoping study where the 11 Board on Radiation Effects research would review the data 12 and say yes, we think a etudy is warranted, and here is what 13 we would suggest is a statement of work that you would 14 charge a committee to do,-and we will reconstitute a
()
15 committee to do that.
16 This group was set up in October of this year.
17 They had their first meeting at the beginning of this year.
18 As you can see, their purpose was to review the information 19 since BEIR, and here was their specific scope.
20 Again, many of the answers that are anticipated 21 are going to come from cellular molecular biology.
We've 22 got a number of folks on tais particular committee with the 23 Hational Research Council that are very strong in those 24 areas, as well as adaptive rePponse and-the epidemiological 25 studies.
One of the things I'd like to stress again is we f~
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I specifically stated that we're interested in low-dose
([
2
= exposures, and by that we're saying 1 to 100 millirem above j
3 background.
Again, we're trying to push the' envelope with j
i
.4 the science.
j 5
A second thing we're very much interested is in-i 6
.tne estimation of the dose and dose-rate reduction factors.
7 Now BEIR V acknowledged that these dose and dose-rate i
8 reduction factors-varied anywhere between 2 in 10.
There's
[
9 an awful lot of uncertainty depending on the system that 10 you're looking at.
We're trying to reduce the uncertainty 11 in these to see are we being overly conservative in our i
12 standards.
i
- L3 Again, as Dr. Pollycove alluded to, we're very 14, much interested in thresholds, but it's not just thresholds f
15 at the organism level, we're talking about organ thresholds, 16 too.
Where this might be significant is let's say overall 17 Dr. Pollycove suggested maybe 20 rem was a threshold.
But 18 what if, per se, we don't have a 20-rem threshold with 19 breast cancer?
Let's say it's 10 or it's 5 or it's 1.
20 That's 50 percent of our population.
Do we set a standard 21-for a resistant population, or do we have to set those for a 122-sensitive population?
And those are the type of things that 23 we're asking the committee to look at.
24-l Genetic predisposition, we're very much concerred 25 there.
Even.the_ molecular biology is suggesting that there ANN RILEY.&-ASSOCIATES, LTD.
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may be individuals in the popult ton that are either
()
.2 repair-deficient-for radiation injury or some of the cleanup 3
mechanisme,~ the apeptitosis.
P53 gene is something that's j
i 4
very much of interest in the scientific community right now i
5 as far as radiation rasearch is concerned, and-that l
6 particular gene product is deficient in abcut 1 in 50,000 j
i 7
individuals.
And-finally, what is the influence of adaptive 8
response and radiation hormesis?
9 The status?
The committee has met about four 10 times.
They held a public workshop in July where
.11 approximately 20-25 individuals were invited to address the i
12 committee as.well as the Board on Radiation Effects 1
i 13
- research, Of that group, Dr. Pollycove was invited to also 14 address the adaptive resporse issues.
Subsequent to that
, ()
15 they met in August, the subcommittee and the board, to 16 discuss preliminary recommendations and conclusions.
And 17 we're anticipating right now two reports coming out of that 18 group in the next several weeks to several months.
19 The first report is we're expecting a letter 20 report in about one week.
EPA has requested information 21 from the Board saying if hypothetically you were to 22 recommend continuing with BEIR VII, and if hypothetically 23-you were going to recommend doing that right now, what type
- 2 4 --
of. things would be in that statement of work, what type of 25 issues should the committee address, and:what type of
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expertise would be needed?
()
2 And EPA has asked for that type of report to help 3
them in their planning process to get a jump, if you will, 4
on the follow-on study, which would probably be anywhere 5
from 18 to 24 months in length.
6 It is not a final recommendation.
The final 7
recommendation will be completed sometime in the January 8
time frame.
They anticipate that going through the report 9
review at the academy relatively quickly, and it should be 10 available in approximately the mid-February time frame.
11 MR. HOLAHAN:
That is the status of those two 12 committees.
If you have any questions, I would be more than 13 happy to answer them.
14 MR. WYMER:
Are there any questions?
(]j
/
15 CHAIRMAN GARRICK:
I would like to ask a couple of 16 dumb ones.
You started off your presentation with the 17 observation that when these groups were confronted with the 18 radiation levels of i..terest, that they reacted quite 19 disappointedly because of the absence of data.
20 One of the things that I have never quite 21 understood about the whole issue of the effects of low level 22 radiation, and maybe you can help me, and I kind of draw 23 analogy with something I do understand, and this is you will 24 sometimes hear people make the obser ation that even though 25 their machine -- let me do an en',.neering reliability
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i 68-1 analogy -- even though their machine has operated for a
(
2 long, long period of time,-because there have been no 3
failures observed, there is sometimes a tendency to-say 4
there is no data, which is absolute nonsense.
The data is 5
extremely rigorous and very obvious.
-6 And-I guess I am struck by the fact that here we 7
have a radiation workers community that has been wearing l
i 8
film badges 1and dosimeters for 50 years, in reasonably 91 controlled working environments
---I remember wearing 11 0 dosimetries of!different types, and fi]m badges of different 11
. types, in the very early '50s, in all kinds of environments 12 of low level rrdiation, from reprocessing plants to fuel i
13-manufacturing plants, to nuclear laboratories, to l
14 radio-chemistry c
. rations, and:yet-we keep saying there is 15 no data.
16 I don't -- I guess 7. just don't understand that.
17 There must be huge amounts of data on workers in radiation 18 --
environments, far-more information than, for example, we 19 have on chemicals,-where_we have not been asked to wear and 20 record our chemical uptakes over long periods of time.
- 21 And I guess I am curious as to why there is such a 4
22 struggle!with-this issue with respect to_ data.
Is it all a 23 matter _of_what pure science' considers a controlled 24' experiment?- Or is-it something else?
25-FUt. ! HOLAHAN: - Well, I think it-is going to be a O.
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combination of a couple of things.
I abstracted this
()
2 particular curve off our web site.
For public education f
3 purposes, we do have a section where we discuss radiation, 4
some radiation biology, the effects at the somatic level, 5
effects at the genetic level.
And one of the situations 4
6 that comes up is the discussion of the linear non-threshold 7
model.
8 Now, within the last two weeks, this very simple 9
curve has generated more e-mail traffic on the rad-safe 10 network than I would ever have anticipated.
And let me see 11 if I can explain some of the problems we have here.
- First, 12 we have risk, and we will assume that this is carcinogenic 13 risk, absolute numbers, is a function of dose.
We have no 14 units on here, other than the fact that at this intercept
()
15 right here we say zero.
So I will presume we are talking 16 zero additional dose above background.
17 Many of the curves that we alluded to have the 18 zero access here as an intercept.
But, in fact, that is not 19 the case.
Because if you look at the 1996 American Chemical 20 Society data, we have a normal mortality rate of 21 approximately 23.9 percent.
22 Almost 1 in 4 individuals that will die in 1996 --
23 or died in 1996, were due to cancer.
Now, clearly, in this 24 situation, that is not due to additional dose.
It is going 25 to be either metabolism.
.It is going to be due to exposure
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1
- to chemicals.
It will be due'to exposure to radiation.
It 2
- could be genetic predisposition. -It will be an assortment 3
things.
But we are going to start off with this baseline 4
4-here, and, again, that is not a real nice finite point, j
5 there is going to be a certain amount of error associated-G with.
7-Now, this.is all nice and fine from an educational
-8 standpoint, so we can show-this nice linear line with a i
9 positive slope, but is that really an accurate depiction of 10 the slope.
Let me pose this to you.
If we look at the risk l
11 coefficients for a population, we can ' increase the risk of:
12 cancer at about 5 times 10'to_the minus 4th per rem.
Okay.
' i 13 So it is 500ths of 1 percent per rem.
So if I move down 14 this by 1 rem, I am going _to increase from 23.9 to 23.95, 15 and where ar.i. we going to see this on this curve?
You are 16 just not going to see it.
17 So that when we start talking about what is'the 18 effect of 15 millirem or'25 millirem, or 1 rem, or 20 rem, 19 this curve-now is going to look essentially flat.
We-are
- r
.20 saying that there is a linear increase, but how does that i
21
_ compare to the background here?
When;you have got literally 22 tens of millions of people dying every year, and you don't 23 know if it is associated with radiation or any of the other i
24-confounding factors they_are going to be associated with.
25[
So, let's say.ne are' dealing with a worker x_
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- population.
And let us also suppose we are dealing with
()
2 20,000 workers at a number of different facilities, whether 3
they be power plants or shipyards, and during the course, 4
some of these individuals, they are only receiving 500 5
millirem per year, and we are looking at 15 or a 20 year 6-working life for these individuals, where we are talking 7
about protr cted exposures.
There is time for the repair of 8
damage.
are, in fact, going to see some very small 9
changes.
So in these 20,000 individuals, you may have a 10 baseline of, let's say, 5,000 cancer deaths over a 20 or 30 11 year period, and we are only going to anticipate an increase 12 of maybe or four, or five, or six, or seven individuals 13 having cancer that might be associated with the radiation.
14 Now, the question I would pose, in a situation
()
15 like that, which individual was it?
The other thing I would 16 pose is what happens to the baseline with time?
As 17 lifestylc changes occur, case in point, dietary changes, 18 going from a roughage diet to a higher fat content diet, 19 there is going to be an increase in stonach cancer.
Is that 20 a confounding effect on the perception of what the radiation 21 dose is, or is it a dietary lifestyle change.
Smoking is 22 another confounding factor.
How do we sort those type of 23 things ort?
24-When we start dealing with the workers, we have 25 another si aation where we don't have a normal distribution ANN RILEY & ASSOCIATES, LTD.
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72 1
of individuals.
The reference to the health worker effect,
()
2 we are already talking about individuals that may enter the 3
work force young.
They are going to be strong, able-bodied.
4 They, depending on their job, may have a decent income, so 5
they can have a good standard of living.
We are hoping they 6
have got medical care and insurance, such that we can get an 7
carly detection of illness with those individuals that you 8
may not see in the general population.
9 Now, the question is going to be, you have got a 10 finite number of individuals.
Through ALARA we are trying 1
to keep these doses as small as possible.
You have got a 12 huge background.
You might have a healthy worker effect in 13 there.
Now, the question I have is, to you, what is the 14 chance that you are going to detect some sort of an increase
(
15 in that population?
And what we find is, in many cases, the 16 epidemiological studies just don't have the statistical 17 power to see that.
Especially when we say you need to have 18 a relative increase of almost 20 percent above background 19 before you can see it.
20 Again, we are talking about doses that Dr.
21 Pollycove was alluding to, that are 5 and 10 rem at 22 Hiroshima and Nagasaki, and we are trying to say, well, that 23 is still in the background, can we say that is part of a 24 linear increase?
Well, the worker is in the same situation.
25 The only difference there is some of those workers might ANN RILEY & ASSOCIATES, LTD.
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73
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receive that over ten years, and it is hard to detect where 2
they are.
3 Now, a number of organizations will-say, if we
~
4 can't get the answer out of_ epidemiology, where are we going i
5 to get it?
The problem we have is is the tools, the 6
molecular tools _aren't sensitive enough today.
Ten year
]
7 ago, when I was in-the lab, if we were Iroking at the 19 induction of single strand and double strand breaks, and 9
trying to quantify those numbers, we were talking about tens 10-of gray of radiation exposure to get enough damage to be 11 able to isolate on Lucient gradients.
And the questions now 12 are in the tens or hundreds of millirem.
With many of the-13 techniques that we have today, we can possibly detect 14
- changes in the cellular and molecular work at 10, maybe 5
()
15 rads, but that is still' an order of magnitude or greater 16 above what we are talking about for regulatory purposes
.17 here.
18 We are hoping that the tools will get strong r so 19 that we can, you know, ascertain what is gcing on here, but 20 now the question is going to be, whether there is an-1ML increase or a decrease, or whatever might be happening at 22 the cellular, molecular level, can we extrapolate that to 23.
the whole organism?
24 CHAIRMAN GARRICK:
Yeah, I guess what I am partly 25 getting at is making a distinction between understanding l
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mechanisms at the molecular level, nuclear and molecular
()
2 level, versus the availability of information.
And I get 3
the sense that this throwing your hands in the air and 4
saying there is no data is a cop-out.
That in terms of the 5
bottom line, namely, mortality rates, morbidity rates, there G
is an enormous amount of data.
And the fact that r;.edy not 7
be able to correlate that down to the detailed mechanisms of 8
repair and damage is one thing, but to suggest that the 9
-information isn't there seems -- strikes me as not correct.
- 0 No. 1 and No. 2, if there isn't the ability to get 11 the kind of discrimination you may be looking for to be able 12 to sort out the effects from different sources, be it 13-dietary or background radiation or whatever, doesn't that 14 also suggest that it is not an important mechanism or
()
15 contribution at those levels? It just seems to me that we're 16 sometimes over-microscoping this thing and not giving enough 17 attention to what I would call -- well, I have to qualify 18 myself.
I am a Bayesian, and from a Bayesian standpoint I 19 just think there is an enormous amount of information that 20 we are probably not utilizing in trying to come to grips
-21 with at least some macro contributions or issues associated 22 with this problem, that we are kind of lost in the repair 23 mechanism and damage mechanism staae and maybe we're not
-24 looking at the forest quite the v4f we should.
25 MR. WYMER; I suspect we ought to move on and
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i 75 t
1 there is an opportunity for discussion among_ participants at j
. 2 10:45.
3 CHAIRMAN GARRICK:
Well, I couldn't help but take i
4 advantage of Vince's presence here because whenever I hear 5'
anybody talk bbout no data I get very suspicious and I think i
6-in:the radiation field there's room for being extremely r
7 suspicicus and that is a personal opinion.
8 I think that we keep looking for the data to give 9
us the answers rather than the analysis of the data, which 10
-is the most efficient way to get the answers.
~
-11 MR. WYMER:
Well, thank you very much.
12 StriccAv i: the context of the LNT discussion, the 13 broader context, ic %
1ike within the next year or two
[
i 14 we will have if not more decisive information certainly more 15 information on which to base judgments and decisions, but it 16 does look like it will be a year or two off before some of 17 these studies are completed and the final reports are 18 approved and issued.
19 That is the impression I get from what you have 20 said.
I 21 MR. HOLAHAN:
- Yes, 22 MR. WYMER:
Perhaps now we could hear just a few
.23 comments from Dr. Yaniv on the Russian experience and 24 related things.
25 DR. YANIV:
I have not prepared any formal l
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presentation and I-have no viewgraphs.
()
2' I just want to add a couple words regarding the O
studies being conducted by NRC and other agencies in the 4
former~ Soviet Union, but before that just one comment 5
regarding.the Seville conference.
6 As Dr. Pollycove stated, the description, the 7
summaries in Nucleonics Weekly and Inside NRC by Ann 8
Mact,achlan were well-done and I couldn't have written 9
.anything more elucidating.
10 However, she did not address one point that was 11
. presented at that conference whid, I think is quite 12-important.
As you all know, the majority of the people i
13.
exposed in Hiroshima and Nagasaki are still alive or at j
14 least were alive during -- at the time of the latest l
15 epidemiological report studg.
16 More importantly however, the people irradiated at 17 young ages, which means zero te 20, more than 90 percent of 18 them are still alive and to assess their lifetime risk of 19.
exposure, models, temporal projection models, have been 20
. developed and the most commonly used temporal projection 21 model that fits best the data is the so-ca21ed relative -risk 1
22_
projection model, which implies that if you see an increase l
23 of 5 percent over an expected level of cancers at age of 20 24
'let's say from a person irradiated at the age of 10, this
'25 same 5 percent will project. to an -: ige of 60, 70 which is the I
i i
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time of increased cancer-risk, because cancer after all'is
()
2-the disease of old age, and this assumption of constant 3'
relative risk model really drives the risk coefficient way 4
up for the people irradiated at a young age.
1 5
Evidence now appears which was presented by Dr.
6 Keller at the conference that as time goes by and these 7
people irradiated at young age their relative risk decreases i
8 with time and if this is -- ad this has also been observed 9
-previously in some other epidemiological studies like
-10
-ankylosing spondylitis in England, t
11 This fact if it is-confirmed, if it holds tp, will 12 have-a very significant impact on the risk coefficient from F
13.
the Hiroshima-Nagasaki cohort.
I just wanted to get thst on l
14 the record.
(I
-15 Now as far as ctudies in the former Soviet Union, 1G as you know there is an agreement between the United States 17 and Russia on cooperative studies on radiation health 18 effects.
Under the auspices of this agreement there is a 19 joint coordinating committee on radiation effects research I
20 and there is an executive committee of which I am a member.
21 The NRC-just about right now signed a contract to 22
. perform a study of detarministic effects among workers in 23 the Mayak Protection Association.
We-talked about. effects not :the-subject of this meeting -- just for the record.
25
'Now the cohort available in Southern Urals, which O'
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78 1-have been irradinted as a result of operation of Soviet 2
Union's first. nuclear weapons production facility, are as j
3-follows.
You have the worker population which number 4-several thousand.
You have the population of the city of_
5 Ozyorsk; formerly known as Chelyabimsk 65 formerly known as l
6 Chelyabimsk 40 -- or not known at all.
7
[ Laughter.]
8' DR. YANIVt And you_have a population numbering 9
into the tens of thousands of inhabitants living along the l
10.
banks of-Teterev River into which in the early 850s raw, i
11 nuclear waste was dumped on the order of several million 12
- curies, j
l 13' Then there is an'.*.her population sometimes 14 overlapping that resulted from the explosion of the waste 15 storage tank in 1957 accident, et cetera._
t 16 Now all studies emanating or papers emanating at 17 this point in time from -- and several were published in the 18 Health Physics Journal, represented three years ago at the 19 San Francisco Health Physics Society meeting, et cetera, are l
20' highly preliminary.
No conclusions should be drawn from 31 these studies.
f 22 Only now, funded mostly by DOE, dose f
-23 reconstruction for the worker population for the Teterev 24 River inhabitantszare being undertaken.
They are in their 25 initial _ stages.
No definitive results can be expected P
w-
~
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. within the next'five years.
The importance of this
) );
- 2'
-population however-is that the total dose received by_the l
13 population, thef- -I'll use a-dirty. word -- person-seivert-or person-rem -- is. comparable to Hiroshima-Nagasaki.
The 4
51
. difference.however is that they received-the doses at the 6
relatively low-dose rate over long periods of time and if 7
and when the, studies are properly done=and completed, they 8
have the' potential of answering the important question --
9 chronic versus acute exposure.
10 "hiei is what my-friend, Vince, alluded.to -- the-11 dose rate-l reduction factor, which is a very important 12 aspect, to what extent the risk is rcduced by protraction.
13' But these studies will not-answer-the question 14 that we;all ask, what is the-effect, beneficial or zero at O
(,/
15 100 MR per year or 200 MR per year.
16 No epidemiological study can answer that kind of a 17-question -- again, for-the reasons that were described by 18 Vince.
19-That is br'.efly in Russia.
Chernobyl -- we are 20 participating in a rather passive fashion with the National 21 Cancer Institute and.the. Department of Energy and 22 corresponding Ukrainian and Byelorussian institutions in two 23 studies of; thyroid cancer-among thoce who were children
. ;24 during the Chernobyl. accident.
Again, these are long-term L25 :-
prospective studies designed specifically to address not-
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-1L onlyfthyroidicancerfbut-thyroid diseases induced by. iodines, 2
- radiciodines,eand answers will not-be-forthcoming'for many, 3'
many t years '._
1 4
Papers ~-have.been published,-presented,
'5
- preliminary.~ There was one in Seville which claimed to 6-indicate a significant increase of thyroid cancer among _
7
. children-from doses as-low as 60 miliseiverts.
I take all 8
these,-whatever it is, given the_ situation, with a grain of 9-salt,1with a rather large grain of_ salt.
10
- In'another study, they did this, right now
[
1L1
'beginning is a feasibility study of leukemia among the 121
- liquidators, the clean-up workers that receive the 13 relatively high doses.
Again, if this study -- this study, 14
' in this study also'the French are participating by an
- p. d
.15 agreement with NRC, and the study is being managed on the 16 U.S.
side by National Cancer Institute.
And in this study, 17-if: successful, will take few years, at least few years, 18 because we will have to wait, we fi'rst do 18 month 19-
. feasibility study, which just began-in November, 20 And, again, the question that this study will 21 answer,-if successful, would be acute versus chronic 22
- irradiation for leukemia.
And -- but do not expect answer 23
- on threshold or effect of the very. low level.
?
- 24-So that about concludes the few words-that I
- 25-
= wanted =to present.
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to, I will at least try to answer them.
(')
2 MR. WYMER:
Thank you very much.
It does appear n.J that there is a great deal of information to be gained from a
4 experiences in Russia.
It is unfortunate that we have to J
get our data that way, you know, from the things that had to 6
happen to the people in order for us to get the data.
- But, 7
nonetheless, the data I am sure will be useful.
8 DR. YANIV:
Well, the data are extremely useful.
9
'The reasons that we are doing, for example, the study that 10 we are supporting, deterministic effects study, is that this 11 have never -- never to be reproduced again, unique source of 12 data, and as far as NRC is concerned, this has to deal with 13-assessment of consequences of severe accident in nuclear 14 power plants.
f~h
(,)
15 MR. WYMER:
Yeah.
16 DR. YANIV:
We have models that are used in PRAs 17 that are to large extent based on animal experiments, some 18 of it exclusively on animal experiments, because we had no 19 human data.
While the Russian have human data.
So it is an 20 opportunistic study, to confinn or slow out whatever models 21 we have, and that is the main reason, main objective.
There 22 are scientific objective also.
23 And the, as I say, the population of the study is 24 unique because they have both external and internal exposure 25.
which is -- which is the kind of situation that one might
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expect-in an accidental situation if one were to occur.
-2 MR. WYMER:
Thank you Dr. Yaniv.
3 Are there one or two, at the most,. questions, that 4
anybody would like to ask Dr. Yaniv?
5-
[No response.]
6 MR. WYMER:
Thank you very much.
7 The final speaker this morning is Dr. Paperiello, 8
who is the Director of the Office of Nuclear Material Safety 9-
-and Safeguards.
According to my notes, he is going to 10 discusG how we can practically obtain results and not just 11 talk at each other, and that would certainly be an 12 interesting approach, 13 DR. PAPERIELLO:
I guess what I really would like 14 to discuss is a sense of frustration on this whole issue.
15 The -- I went to the Seville Conference expecting to hear 16 some debate, and there wasn't any.
I thought it was -- it 17 was the strangest scientific conference I ever went to, 18 where the 50 to 60 percent of the time of each session was 19 dominated by invited papers.
They call them keynate 20 speakers, but where I come from, I am a physicist by 21 background, we would occasionally have invited papers at 22 scientific meetings I have gone to, but this is the first 23 time where they dominated.
24 Contributed papers, some of the authors were-25 invited to speak.
They got three to five minutes.
And then
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83 11
.theitime spent'in discussion was strange.
I was on:one
!21
- panelftalking;about, youLknow,.the regulatory; impact, and I-
-3 Ewound Op1having-representatives of4IAEA and ICRP answering i 4
- all-the questions _and not the panel.
So it was kind of a
~
~5 strange, a strange meeting 6'
But putting that particular meeting asid - and.
7 criticism of that particular meeting, my problem is_how do I-8-
bring this issue -- quit debating the issue and start -
. 9 getting answers?- How do I get -- it almost:looks like the ICL
'linearists, and that is-probably c bad term,-but anyay there
- 111' is one pool of people, with their interests, and they talk 12 to themselves,-and the-people who don't believe the linear 13-
.model, for one reason or another, they, talk to themselves, 14 and nobody really gets. - really gets engaged.
That's what
()
15 I would like to do.
'16 I am not an expert in health effects.
I am a 17'
_ nuclear physicist by education.
I happen to be a health 18-physicist by what I went into when I got out of graduate 19 school.
Obviously, in my -- my background.is. environmental
'l 20-monitoring for the State of New York, before-I became a 21
. regulator with.the NRC, and I have done inspection, I have 22-
-been on the licensing side and the reactor side, so I am 23 ftrying to get a job done.
24
,And I can read-arguments, and what I see-rightenow 25 is an-awful lot of plausibility arguments and nothing, and i O.s.
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no way -- and lack of resolution, and almost the parties
[)
2 ignoring each other, other than dismissing the other one.
3
_So_how do you bring it together?
I guess my view, 4
and I ra.ve presented this both at the Wingspread Conference 5
at the -- at the Seville Conferences, I am not sure 6
epidemiology -- I agree, at very low doses, it won't prove 7
the linear model.
It could disprove it.
But I don't think 8
it will prove it.
I think the Russian data might help us on 9
this dose rate effectiveness factor.
10 And, by the way, you realize that is a " fudge 11 term," or as I had a remark -- somebody in ICRP said to me, 12 yes, it is linear, but the slope is different at low doses 13 than high does.
So --
14
[ Laughter.)
b
(,/
15 DR. PAPERIELLO:
And so that's really what we have 16 said.
The slope isn't -- you know what we are really 17 admitting is that it is not linear.
18 I think molecular biology is clearly going to be 19 where there is an answer.
But right now I feel all the 20 arguments I have heard are plausibility arguments.
There is 21 plausibility behind the linear dose model.
On the otaer 22 hand, you can find plausibility why it is wrong -- why it is 23 wrong.
Example of the adaptive responce.
24 I think the session on adaptive response was very 25 interesting in Seville.
The conclusion was, well, the doses
[
)
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we use are too high to be e.gnificant at real low doses,
( ')T 2
because they are talking about an adapting does of somewhere L
3 on the order of several_ rem, and then a challenging dose of 4
several hundred rem.
5 On the other hand, the molecular mechanisms are 6
important.
Why?
What is going on?
I think an understanding of what the -- in other words, once you know 8
the molecular mechanisms, then you can model the curve and 9
see whether or not you get -- you know, what kind of a line 10 you -- or what kind of a curve you get.
11 I am bothered by the fact that Bernie Cohen's-data 12 on radon is just dismissed.
I don't see why that data is 13 any poorer than, in tenas of -- and I hear confounding 14 factors are the reason uhy you can't trust the data, but I O
( j!
15 don't hear the same thing on miners.
I really wonder, when 16 you go back and J ook at the mining population in the '50s 17 and '60s, how good that dosimetry really was.
What were the 18 confounding factors?
I don't know what the controls were on 19 that parcicular population.
20 So there are some issues there that -- but they 21 talk, each parti talks around each other, and I,
- frankly, 22 don't know how to bring the parties together.
You know, the 23 argument usually is in science, we have a strong enough 24 debate and eventually we arrive at the truth.
But in-this 25 case, I don't really find a debate.
I find one group --
[~'
\\s-)
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86' 1-each group 11s in its own corner and is talking to its own
)
-2 adherents and I-don't:see -
and now and then lobbing a L-3 L
- shell'over to:the over_ side,lbut I_ don't-really see.
4:
[ Laughter.]
5-
.DR.
PAPERIELLO:
I am not -- you know, I am giving 6-you the view of a person who. is trying to get a job done in 7
this thing.
8 I will make a remark, because I altered my-9 presentation at Seville based on what I heard, that ICRP, I 10 think it is weak in the area of r3sk management.--I mean 11 what they would do is they would support a risk assessment.
12
-Their slope is.05 per seivert, but then-they achieve their 13 radiation lovels, which were, for my viewpoint, were 14 acceptable, but they would assume -- they based the public
-()
15 considers a risk, an annual risk of 10 to the minus 4 as 16 tolerable.
17 And-I, in my presentation, I pointed out 10 to the
-18 minus 4, public acceptance-of risk is tolerable isn't a 19 constant.
Some people would accept 10 to the minus 4 for 20
- driving-their own car, because they know they are in control 21 and they are a safe driver, they will never have an 22 accident.
On the other hand, you tell them the risk is 1 in 23 10,000 of getting radiation poisoning, which as we all know
.24 from movien is a horrible way to die, that is intolerable.
-25 In-fact, for me, it is zero.
-/
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And so there is a problem, and I don't_think I see
[^ )
2
-- and I had-other regulators come up to me-and tell me
%J-3 you're right.
Their outright statement that people will 4
tolerate that risk is wrong.
5 Anyway, I come to you today to bring that problem.
6 I don't have an-answer to it.
I don't know how -- I don't 7
know how to bring the parties together.
And I guess my -- I 8
have a sense of frustration that we are going to just keep, 9
you know, worrying this thing to death, and we are never 10 going to resolve.
And each party is going to be quite 11-happy.
In the meantime, I have to live in this regulatory 12 environment.
And as I told the meeting in Seville, I have 13 to regulate at levels two to three orders of magnitude below 14 any level for which I have, and even they would admit they O
(,/
15 have an effect.
And, you know, we are talking about 16 regulating.
That doesn't -- that means coercion.
17 I think some of the scientists in some of these 18 groups don't really understand what it means to regulate.
19 It is not a good idea or something like that.
It means you 20 go over the line and you are -- there is going to be 21 sanctions taken against you.
And we are talking in the 22 United States about spending a lot of money.
We are talking 23 about -- yourself, you know.
We are talxing about cleaning 24 up to levels on the order of-either 25 millirem a year, or 25 15 millirem a year, or ground water to 2 millirem a year, or
(
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14:milliremia year, or something~like that.
We are talking:
- 2' about a;: lot of money.
And:there are alternative uses~for
-3 that money, andisome of which extend human life ~.
.4 I guess what I am-bringing to:you for suggestions-
- 51 tis how we_canLget the parties here to'truly engage and not"
'6:
eachione dismiss the other one and try.to solve the problem.
7-MR.-.WYMER:
Thank you.
That certainly sounds like 8
the' issue as far as a regulator is concerned.- We have'some 9
time scheduled for-general-discussion among the participants 10 andithe audience too, as far as that_goes.
Anybody1 care to l11 participate?
12-MR. HORNBERGER:
I have a quick question, Carl.
13 You know, we've heard again this morning that the basic 14-argument or perhaps-even admission on both sides is that
)
'there aren't any data, and that there are -- you said 15 16 yourself there are unlikely to be sufficient data in the 17 near future.
18 How does one engage -- I mean usually in science 19-as you put it when we engage in a dispute.it's either based 20 on theories that are pretty fundamentally sound or it's 21 based upon data.
And it strikes me that this kind of 22 discourse'at very low levels is apparently hindered-by the 23
' fact.that nobody' admits that-there are any data to go.on, 24 and'nobody admits;that.there-are any -- there's any
'25; theoretical model:that's defensible.
a-<
[-
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i 89 1
MR. PAPERIELLO:
I think you can formulate (G')
2 questions that can be answered and asked, and then you look 3
at.
For example, let's suppose that the mechanism that 4
we're hearing about the induction of cancer from radiation 5
are these complicated double-strand DNA breaks.
Fine.
6 Okay?
We know that 23 percent of the population will die of 7
fatal cancer.
We know that with a slope of 5 percent per 8
seivert that somewhere around 450 rem, there ought to ba as 9
many breaks as occur spontaneously in a lifetime.
That 10 something is worth investigating.
I know from talking to 11 Myron his estimate of double-strand breaks is enormous.
But 12 what I heard at Seville, well, it's not just double-strand 13 breaks, maybe it is some kind of varnish double-strand 14 breaks.
O
(,,/
15 So that's what I'm saying, we've got a 16 plaucibility.
That's what I'm trying to get the -- that 17 would be something I'd like to -- I wish we would have had a la good debate.
I coulo hear a debate among the molecular 19 biologists on the difference between the spontaneous rate of 20 breaks, double-ctrand breaks, versus what's to be induced by 21 radiation.
But that doesn't get discussed.
I think there's 22 an issue of some -- of data that tends to show hormetic 23 effects.
As I said, Cohen's data.
I don't think I see it 24 dismissed.
I've never seen any of the tarious NCRP, ICRP, 25 or any of these organizations seriously look at the data.
[
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It gets tossed off as an ecological study.
It doesn't
[\\
2 count.
- (_)
3 But the fact of the matter is if I would argue --
4 I might agree with that if I had one community compared to 5
another community.
But you've got multiple communities, and 6
it's a continuum.
I've already said-somewhat sarcastically that if I lived in an area of high radon, I wouldn't have to N
8 worry because the-confounding factors would protect me.
9
[ Laughter.1 10 Because that's all I hear.
But the fact of the
'11 matter is I know what confounding factors mean, and I know 12 what the problem with the ecological fallacy is.
It is that 13 although I measure oomething in a given area, that doesn't 14 apply to the people in the area.
But the fact of the matter O
(,/
15 is radon is measured -- these measurements were ma6e in 16 people's homes.
It ought to be somewhat representative of 17 what the people are getting.
If not, our entire radon 18 program in this country is worthless, because it means that 19 measurements of the radon in your home doesn't influence 20 what you get.
21 Now when you start arguing about well, we don't 22 know what the smoking is.
Supposedly Dr. Cohen looked at 23 all these things.
We have had people from NIST look at it, 24 and they've decided that his statistics were valid.
So the 25-question is, what is the confounding effect?
And there has
[
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--li
- to ; be ;ax continuum.. In other words,-as the_ radon goes_up,:
()
21 this; confounding effect has to-1just go' proportional, because
=3 the1 data isn'tJa major scattergram,-it's-a relatively6you 4
know,Jobviously1:it. wobbles, but'itJgoes ---it's pretty!
5' isteadyJ And that's an argument I'd"like to hear really.
-6 thought out, bue it isn't, it's just dismissed.
7 And so these are the things that I find troubling
'8 in this-problem.- -HowLdo you get the people to, you know,-_
9 really, at least to my -- as I said, obviously I'm a
- 10-
-scientist, but I'm not a molecular biologist, I'm not;'an til-epidemiologist, and all that.
But-I think I'm a fairly 12:
-rational person, and I know that the scientific principles
- 13s iof how we,=you know, now you weigh evidence and things like
- 14 '
- that, nd-I don't see a satisfactory argument on this whole.
()
15' thing.
It's sort of-each group's side dismisses the other 16 Rand goes their own way and talks to themselves, and it just 17 idoesn't resolve it.
I've been quoted, and I actually did 18 say this, butLnot in-a public statement, but an aside to
.m 19-somebody, _it was more like a theological gathering than a 20 scientific meeting.
213 MR.'FAIRHURST:
You were talking about just 22 getting the Academy of Science to sort of take a study on 23;
- your behalf, right, of this problem.
How is that
- - why 24 doesn'tithatt deal-with-the issue?
You're requiring the;
- 25 l study.
) _.
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i 92 1-MR. PAPERIELLO:
My observation is when I look at
(
)
2 these various committees they're self-perpetuating, there's 3
interactions between members that sit on one, sit on the 4
- other, 5
Right.
6
-MR.
PAPERIELLO:
And you really don't have the 7
independence that you would -- that I would, you know, that 8
I would really like to see.
But on the other hand, I can 9
argue yeah, you want independence, you want people who are 10 ignorant.
11 So, you know, and I can understand that.
It's --
12 but look, if you read the history of science, you know that 13 people resist.
Ernest Mach didn't agree with Albert 14-Einstein, yet Albert Einstein had a high respect for Ernest (D
(_,/
15 Mach.
He was the dean of German science.
The same thing 16 would be said about Arthur Eddington and black holes.
I 17 mean, the theory was all laid out in the thirties and he 18 squashed it.
So, I mean, that's the, you know, we know 19 these things go on, and so it's --
20 CHAIRMAN GARRICK:
Carl, one of the things you 21 said that I think is very true and is very important, and it 22 suggests that maybe what needs to be done here is the 23 adoption of a different strategy, and that is that you made 24 the observation that there are questions that can be 25 answered.
It seems that as long as we're lining up linear l
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proponents with nonlinear proponents and having as an end
)
2 objective the getting of a curve that we all accept that (V
3 we're probably never going to get there, at least there's 4-this discouraging prospect here that science doesn't seem to 5
be working very well.
Maybe if we look at it, it's not much 6
different than any other problem that's been attacked down 7
through the ages, and maybe it's just a matter of how 8
science in fact does work.
9 But one of the concerns is of course there seems 10 to be institutional commitments here that have to be guarded 11 and protected, and that that possibly is interfering with 12 natural process of scientific investigation and the exposing 13 of truth and arguments that well, this experiment wasn't 14 quality-controlled and this one was, and maybe -- and I'd
/
- \\
15 like to hear your comment on this.
Maybe what we should be 16 doing here is going back to a different question.
Rather 17 than a question of a dose-response curve, back to the 18 question that has been debated before, with no more success 19 than the dose-response curve, but that is the question of 20 well, what constitutes a reasonable threshold for managing 21 radioactive waste.
22 I don't think the public is as cognizant of the 23 costs of implementing a radioactive waste program using 24 linear criteria as perhaps they ought to be, and is there 25 any merit in avoiding the contest that's going on and ANN RILEY & ASSOCIATES, LTD.
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refocusing.on criteria or guidance for radioactive waste (J~)-
2.
management with respect to a threshold?
3 MR. PAPERIELLO:
Well, as I mentioned, I thought 4
that in my presentation at Seville, which I did sharper.
5 after I listened to the other presentations that went before 6
me, that you had to separate out the issue of risk 7
assessment with risk management.
The problem with risk 8
management when you look at it is there is a lot of 9
political factors or a lot of factors that we would call 10 and -- combine and call political factors.
11 I noted again the public doesn't see risk as one 12 number as acceptable.
Can I avoid the risk?
If I can avoid 13 it, it's less tolerable.
I tolerate things because I can't 14 avoid them.
Who benefits and who pays the consequences?
()
15 You're telling me I get a chance of getting cancer and that 16 person over tnere saves $100 million.
That's not acceptable 17 to me.
You know, 1"'s -- if I thought I was actually paying 18 the money, maybe I would accept more risk, but if I think 19 it's somebody else's cost, you put it off.
20 The issue of again what's the cause of death?
21 People fear cancer more than things like high blood pressure 22 consequences, things like that.
That's a known fact.
How 23 much control do I have over it?
The reason why we tolerate 24 as many people dying in automobile accidents is most of us 25-feel we have control and it's not going to happen co me.
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95 1-Having once-rolled a car over and having the entire family
[G) 2.
walk away unharmed many years ago, I have a lot of respect 3 -
for cars.
It's, you know, I don't think I'll ever do that 4
again and walk away alive.
So, you know, it's -- I hear 5
what you're saying, but, you know, it's almost if I can't 15 solve the problem on the waste assessment side or 7
risk-acsessment side, I'll~go over to risk management.
8 CHAIRMAN GARRICK:
But I guess my point is maybe 9
it's more of a timing question.
I'm not suggesting we 10 shouldn't try to solve it at the basic scientific level.
11 Indeed, we should.
But in the meantime, as you said it very li well, we've got a job to do, and we're probably doing it 13 extremely irresponsibly.
14 Partly because of the criteria that we h&ve A(_,)
15 adopted by which to solve it and probably we are solving it 16 totally out of context with the way we are solving other 17 problems *, hat are a threat to life, and somehow we seem 18 to -- and the proponents of sustaining these solutions -- we 19 seem to be not held accountable for that.
20 I wonder why that is.
I wonder why there isn't an 21 absolute outrage to come up with criteria that is (a) 22 consistent with the way in which we solve life-threatening 23 and health-threaten ng problems in other industries, for d
24-example.
You know, we are denying society the option here 25 of using nuclear to possibly be a major factor in saving the
-(
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'1 1 planet in the: future..
[
- - 2 ~
It?just strikes _me that there are. extremely _
~
-+
-- 3 L
--important-accountability questions here that-are getting; i
14j
. totally-lost:at the molecular-biology.leve11that may-not be 5
'all that-relevant in the grand scheme of things'if we~take 6'
-full advantage of what.we are learning from the forest 4
7 rather'than the trees, and this industry seems-to be caught 8
up in that more than any other industry.
9 DR. PAPERIELLO:, I don't have an answer for you, because it's my perception that people don't treat all risk 11 as equal.
They don't do it in their own lives, As I 12
~ mentioned again at the conference, people regard radiation 13' from medical or background as different than things that are 14
" nuclear" -- I don't know how you_can change that.
()
15' There is an interesting book out called " Nuclear
- 16_
Fear" by Stefan Wearst, who is the Historian for the 11 7 American Physical Society.
It is about 10 years old now.
18
.The book--happena to be in our library.
I have my own copy.
~19 He talks about how people from the time radiation was 20 discovered up to the mid '80s, radiation is regarded much 21
,like magic was 400-500 years ago.
22 You recall when I talked about risk management, 23.
think of!the principles of managing the risk from witches 2 4 --
L300_ years ago.. Mankind.has a high capacity to be
-25 irrational.
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,I(dont have-an answer.
IfthinkLwhen you~are 2'
dealing in0a= political arena,-and you can take a look around 3-
- you-and see'how not all, even medical risk,--certain medical 4
-risk, you know,Jailot-of emphasis is placed on AIDS, but the 5
fact of the matter is people like myself who have 6
hypertension, we have a higher death rate'---that represents 7
a higher risk over a-long haul.
More people are affected.
~
8-There is another-interesting book called "Against 9
Method" by-a philosopher by the name of Paul Firerobint at. Berkeley, who-hates science.
In fact, he hates Galileo --
ill it's an interesting book-to read.
12
[ Laughter-.)
13 DR. PAPERIELLO:
That, you know, scientists plead 14 causes -- there is no preferred form of knowledge over any
,-(
15
- other.
It's just a fascinating book to reo.d. so I mean all 16 these people make up the United States of America.
All 17 these' people vote.
18 I could take you to a book store on the South Side 19 of Wheaton, Illinois, near where I lived when I was in the 20 Midwest in an area which is either a lot of scientists or a 21' lot of -- Wheaton is a very religious town.
Wheaton College 22-is the alma mater of Billy Graham, and the number of books 23 in that bookstore devoted to things like " crystal power" and 24 New-Age stuff' exceeds the number' feet of books devoted 25' either theology or science, so obviously, you know, there's
))
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-1.
people:who believe' things:to be-true_thatLI as_a scientist 12
-find [ impossible.to_believe and this is not -- risk
-_ management 11sHan interesting-subject in-itselfJand-I don't-
- 3 ---
4 know ok a scientific basis"for it.
There'probably is'one--
l but I just don't know one.
5 6
MR. WYMER:
Let me-take a slightly different tack 7
on this business of deciding what an_ acceptable risk is.
8 I think there is'a strong cost-benefit element =and-9 it is time dependent.
It seems to me that the major cost 11 0
- factor is with respect to-how much you clean up a site, what 11 you are-required to do, and granted that then isn't it 12
-important-to know when these costs will be incurred and at-13-what rate, and how the time; dependent curve will be with-14
. respect to the cost and doesn't that give us-some good
(
15 l measure of how fast we have to arrive at some acceptable 16 risk?
Ji7 --
Maybe we-can wait five years or maybe we should 181 have done it yesterday.
19 I would like to have your conments on that?
20 DR. PAPERIELLO:
I think that is an interesting 2L
' issue.
I think-it's' tied up with'the issue of institutional 122 control'.
I have-felt.that we have been relatively 23 pessimistic =aboutLinstitutional control because I could
-24
.think off the1 top of my head, I guess'somewhere in one of 25 our-rules we-use-'something'like 100' years, and'I can-think
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i.
1 of an:e number of sites in the United States that have been
)
2 under the control of the Unite 6 States Government for
[G 3
somewhere on tha order nf 200 to 250 years -- in particular 4
Fort McHenry up here in Baltimore -- or West Point in New 5
York, any number of facilities that the Federal Government D
6 has been in control over.
7 I also distinguish -- again, this is something I 8
thought about when I was in Spain -- that there is two 9
levels of institutional control.
One is where you have the 10 ability to intervene and then one where you may not have the 11 ability to intervene anymore but you have the ability to 12 keep people away.
13 In other words. mankind seems to remember what was 14 done at the Pyramids for a period of about 4500 years even i ()
15 though we in many years lost the ability to build new 16 Pyramids or of course as in today we don't have the will to 17 do it -- we have no particular -- I suspect we could if we 18 wanted to, but we don't want to.
19 So you have the concept of discounting.
I think 20 if you know the words -- what is the value in the future.
21 In fact, a little bit of thought -- and I did this in 22 respect to Yucca Mountain -- if you put aside $10,000 and 23 you let it accumulate at the rate of 2 percent per year real 14 interest, real rate of return, and calculate how much money 25 you'll have at the end of 10,000 years is on the order of 5
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trillions of dollars,-solit isieasy to-create a perpetual leare fund _for-a site-Llike,that.
3; I think there are things-about the future-value::
-4:
that you could=probably get in there.
5.
Let me-tell you the one weakness I think in 6
' cost-benefit.
I think -- to me it is attractive.
I like 7
the idea, but logically'I think you get into the problem
~8 that you had with utilitarianism.
That sounded like 9
- something. good -- you know,'the greatest good to the
=10 greatest number.- The-problem is once you got beyond food, 11 shelter, clothing and certain basic necessities, the-12 question is competing " goods" is a vacation somewhere 13 equivalent to a: stereo system?
You know, something like 14' that -- and that is where-I think you have some of the DV 15 problems.
16 I think the other issue with cost-be.
Cit, as I 17 mentioned earlier, is who pays-and who benefits, or again in 18 one of the remarks I made in Seville, I said I have cases 11 9 where the person who pays, the person who benefits and.the 201 person who undergoes a risk may be'three separate things.
21 In other words, if I clean up a facility, somebody W
22 pays to clean ~it up.
The person who will reside there
- 23 benefits,.but some other community who-gets the waste will
-24 pay the risk.
You know, how do balance allithat stuff?
25-MR. WYMER:
My point was just a little different
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_than_that, as'I am sure'you know.
7 I
i' 2
It was the cost-benefit not in the absolute sense LJ -
you are talking about but in the sense of how much time do 4
we have bef,re we have to arrive at this decision as to what 5
the acceptable *isk is, and that is sort of a different way 6
of looking at the cost-benefit.
7 DR. PAPERIELLO:
Well, you could obviously store 8
spent fuel for 100 years before you worry about disposing of 9
it.
10 MR WYMER:
I was thinking with respect to 11 cleaning up sites more than --
12 MR. PAPERIELLO:
Well, that would be the other 13 thing, too.
You could put sites in the safe store.
And we 14 do that.
We don't call it that, but think about all your
()
15 RCRA facilities.
What are they, on the chemical side?
16 There's no disposal.
That stuff isn't going to decay away.
17 That's indefinite storage.
18 MR. WYMER:
It's a tough issue.
19
-Are there any other comments from any of the 20 speakers or any of the participants in the audience?
We 21 have another ten or 15 minutes left for stimulating 22 discussion.
23 MR. FAIRHURST:
I don't know whether I really have 24 a comment.
It seems to me there has been some evolution of-25 thinking with regard to environmental concerns.
You know, O
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25, 30 years-ago,vthere1was*a feeling-that we created some
()
12T
. problems 1that could be cleaned up, and it was a relatively
~
4 3'
simple thing.to do.
Nowadays,-when-people-are starting to
~
'4' go out'with contracts and.say how much willuit cost, there
'5-
~_> realization that you're going to commit a significant 6
fraction of national resource to this, and so the debate as 7
to how to allocate funds -- I'm not talking about risk ---
8
.and how much you're willing'to pay more in taxes and the 9
govarnment-is-talking about cost reduction here and cost
.10 reduction there, but the climate is changing in which one
-11 could pose some of these problems.
12 I' don't have an answer to it, but for example, if
.13 you say it's going.to cost us X billions of dollars to take 14 care of it, well, what if.we allowed the cancer research
(~
. (,)f 15 people to get half of that money -- would they advance and 16 solve our linear no-threshold hypothesis more rapidly and,
.17 therefore, come to a more -- you could modify the limit some 18 five, ten years -- I'm asking this sort of philosophical 19 question we're posing, and --
20 MR.-PAPERIELLO:
Let me make another observation.
21 I suspect by the time we get all the answers for molecular
.22' biology, we will know so much that we'll be able to cure 23 cancer, and-maybefit will be a moot issue.
~
24 MR. FAIRHURST:
Yes.
25.
MR.-PAPERIELLO:
I mean, there are some of the O
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- problems 1-- -when you talk about discounting,1what is1the-
' 2 --
world going to be'like in_a thousand years?_
I mean, I think
-3 that we haven't-the-foggiest--idea what the world is going to beelike in a thousand years,-land'we have no way of 5
projecting it, and because my -- again, my_ analogy is,-okay, 6-
-it's.1000 A.D.,
I want to know what the world is going to L7^
look-like in 2000 A.D.,.so I go to the most educated people-8' I can' find,1I go to the Monks in, you know,.in Paris, with 9
no disparaging intent, they couldn't tell me what the world 10 was going to look like in a thousand years.
ill The other thing that struck me when I was in 12 Spain, being-in Seville, and my wife went over to Cordoba,
-- 13 and realizing that in 950 A.D.,-Cordoba was the second 14 largest city in Europe, had a major university --
O
(,/
15 universities and a-center of learning and all that.
We in 16 the United States are affected by a very poorly taught 17 history.
We never studied sorld history, we studied 18-European history, and European had something-called the Dark
-19
_ Ages,fand I think in back of our minds, somehow civili=ation 20 is going to collapse and we're going to go into a Dark Ages 21 and all kinds of_ horrible things are going to happen, and-22-our descendants who have now revered to a level of barbarism 23 are going lto run'into problems.
1 24S But the fact of the matter is, Europe, between 600 25 and 1000 A.D., may have had a Dark Ages; IndiaJhad a golden 3001 RILEY & ASSOCIATES, LTD.
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_ age,,;I've-been told, in 800_A.D. -The Byzantine-empire _was-
- 2~
goihg-greatcguns between Justinian and I'm told the 3-
-Venetians went and sacked-the-thing-around-1200 or so, 4
Obviously the rest-of the Mediterranean -- you had Islamic 5
civilization _allLalong the_ southern base of the-6 --
Mediterranean, all the way up.to the Pyrenees.
So really 7-the Dark Ages that we sort of have this mental image of 8
laffected Europe from Rome and north, north of the Pyrenees, 9
and not the rest-of the Mediterranean world.
It's certainly 10 I don't know what went on in-the rest of the world.
I 1:1-Lhave'no idea what went on in the Orient.
12 I think that has a lot of -- I can remember I 13-worked for New York -- when I worked for New York State at 14 one meeting people actually debating what was going to A(,/
15 happen to the low-level waste disposal site after a nuclear 16
- war, 17 (Laughter.]
18 MR.:PAPERIELLO:
As if, you know, that was -- and 19 I think there's an element of not just absolute _ risk, but 20 relative risk.
If, in fact, civilization in the United 21 States gets?to the point where people do not remember what
-22 we did-in Fevada, I suspect'it would be an upset condition L23-that would kill so many people that a few extra cancers from 24 Yucca Mountain probably will be trivial in comparison.
i
_ 25 Think about-it.
What-would you have to do?
You would e
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105 1-
-probably-have toikill 98' percent of the-people in the United 2
States.
3 I-mean, you know, if we reverted to barbarism like 4
'the American -- you know, Native Americans,.this North 5
.American only -- North America'can only support a couple 6
million people living that way as hunters-gatherers, you 7
know.. So-you would have to kill off 98 percent of the 8
population.
I mean, tha*.'s a horrible consequence.
9
.So in terms of relative risk, I just have -- I 10 have a' lot more confidence in the future.
I think we can --
11 I.think institutional controls will work for a long time,
-12 MR. FAIRHURST:
What I am suggesting is that 13 perhaps the public is a little more accepting of reason than 14 you have probably been suggesting, and not just because it's 15 going to hit their pocketbook.
16 MR. PAPERIELLO:
I guess my view is the public
.17 acceptance will grow or: change if there is a perception of a 18 strong need.
19 MR. FAIRHURST:
Right.
20 MR. PAPERIELLO:
I think as people would-say, if I 21 can.get my electric power and do the things I want to do 22
-from coal, I'm-happy to take coal, which I think I know, 23.
versus nuclear, which I don't know, and if people feel the 24 only way they can get electric power is from nuclear because 25 of the greenhouse effect, then maybe.there will be more ANN RILEY & ASSOCIATES,'LTD.
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acceptance.
$I31 2
I mean, there's a factor-that part of this issue
-q 13
- is people,_you knowi like the oldfandicomfortable, don't 4;
like thefnew.
Radiation-is mysteritus.
I don't have a good
.5 a n s w e r.-- I mean, I don't -- I have read _enough history that 6
I~can understand how people come out the way they do; I just 7
don't know how to make a -- effect change, because most.of 8
the change that has occurred doesn't seem to occur through a 9.
very calm, rational, you know, decision; it usually.is 10-episodic and1unfortunately.gets accompanied by violence.
11 And I don't mean in a sense -- but some kind of a trauma, 12 CHAIRMAN GARRICK:
Well, maybe that's the 13 strategy.
14-
[ Laughter.]
()
15 MR. PAPERIELLO:
Well, you think about it.
Think 16 about social changes.
I mean, to abolish slavery in the 17 United States, we had to have a war.
Democracies came about 18 really_from violence.
I mean, whether it was in France, the 19 French Revolution, the American Revolucion was certainly
.:M)-
much_more ---but it's just an historical fact.
You have C
21 major - -there are --' there is usually trauma when there is 22 a major social change.
Even the industrial revolution,.
1 23 there was a lot of trauma when people were shoved off the 24
-landiand you had the closure.in England and things-like 25
.that..
There wasn't a -- it wasn't something that wasn't ANN RILEYJ&. ASSOCIATES, LTD.
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accompanied by a good deal of trauma.
2 MR. WYMER:
Do you have any feeling at all, Dr.
.L 3
Paperiello, about when we ought to -- when the NRC ought to 4
come out with an acceptable risk?
What's the timing of 5
that?
6 MR. PAPERIELLO:
No, I can't answer that.
I think 7
that's going to be a policy deci,sion by the Commission.
8 MR. WYMER:
But they will accept input certainly 9
from people like yourself.
10 MR. PAPERIELLO:
Yes, I'm sure they will.
11
[ Laughter.]
12 MR. WYMER:
I think I understand why you have high 13 blood pressure.
14
[ Laughter.]
()
15 MR. PAPERIELLO:
I've been told by the doctor I 16 didn't pick my parents very well, so it's genetic, in the 17 family.
18 CRAIRMAN GARRICK:
Well, it is exactly noon.
19 Unless there's some other contributions that somebody wants 20 to make, maybe we ought to declare that we're ione for the 21 morning.
22 Thank you very much.
23 CHAIRMAN GARRICK:
All right, Then I guess we 24 will adjourn until-1:00, 2S
[Whereupon, at 12:01 p.m.,
the meeting was ANN RILEY & ASSOCIATES, LTD.
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108 l'
recessed, to reconvene at 1:00.p.m'.,-this.same day.)
l O
2 3
4 4
l 5
6 i
7 8
l 9
10-
.11-12 13 -'
i 14 O
15
~16 17 l
18 i
19 20-
=21~
1 22 23
'24 25' i
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109 1
APTERNOON SESS?,0N L( )
2 (1:00 p.m.)
l.
3 CHAIRMAN GARRICK:
The meeting will now come to 4
order.
5 This is the part of t..e meeting where we have sort 6
of a fires 4.de chat with the executives of the NMSS and 7-Division of Waste Management.
8-Today, we're going to hear from John Austin.
John 9
is the: deputy chairman of the external regulation of DOE 11 0 task force.
This is a-subject-that's of great interest to 4
11 the committee, and we're grateful that you could come and 12 spend some time with us.
As I understand it, Carl 13 Paperiello is the chairman of the task force.
j 14 So with that, and unless there are some questions-(
= 15 or announcements, why don't you proceed, John.
16 MR. AUSTIN:
Thank you, Dr. Garrick.
17 You know, mentioning Carl-is reflective of the 18 importance that the Commission places on this activity.: I 1
d 19 have sometimes likened the issue of external regulation of 20 DOE _to cicadas.
About every seven years, they pop out of-21 the ground, make a lot of noise, and then slowly die away_to 22 repeat tha' process.. But this time, it seems a little'more 23 serious.
24 What1I_had proposed to do is go over some of_the 25 background,.because there are two-new members on-the O
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110 I
committee, and then talk about some of the potential
()
2 benefits of external regulation, a memorandum of 3
understanding that has been developed, what the objectives 4
are of the program and how we're approaching it, and then 5
talk about where we're going from here.
6 On the background, as you know, DOE has 7
self-regulated its facilities since 1946 when it was first 8
formed as the Atomic Energy Commission.
In recent years, 9
there has been an exception to that in that environmental 10 legiolation brings the Environmental Protection Agency and 11 through EPA some of the states to have oversight of 12 environmental matters at DOE facilities.
13 OSHA has no jurisdiction over DOE facilities 14 becauso DOE has a worker safety program; therefore, OSHA
)
15 does not extend to those federal facilities.
16 Back in 1994, on the House side, there was some 17 legislation proposed that would have required all new DOE 18 facilities to be regulated by NRC, and it would have created 19 a commission to study what to do about the existing 20 facilities.
Then Secretary O' Leary made a counter-proposal 21 to form an advisory committee to look into these issues with 22 the thought that having DOE examine extensively itself, it 23 could then go to Congress and make some informed 24 recommendation to Congress.
25 In January of 1995, DOF formed the Advisory O
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CommitteeHon External Regulation of DOE' Nuclear Facilities.
fh 2
It was'co-chaired by John Hearn and Gerard Scannell.
You 3
all )n,w John Hearn is former chairman of the Nuclear j
4 Regulatory Commission.
Gerard is the president of the I
9 National Safety Council and he is the former head of OSHA.
)
6 They looked into this issue -- it was composed of l
7 over 20 people from industry, f roia states, from 8
environmental groups.
So there's. quit' a cross-section of l
9 interest-in that committee activities.
10 Their recommendations were that essentially all 11 aspects of DOE activities should be_ externally regulated; 12 however, they were approximately evenly divided over who
-13 should engage in that external regulation.
The options were
{
14 the Defense Nuclear Facilities Safety Board with an expanded
()
I 15 role going beyond its current advisory role to the Nuclear l
16 Regulatory Commission.
17 Secretary O' Leary accepted and endorsed that 18 advisory committee report and formed an internal working 19 group chaired by Tom Grumbly to implement the advisory 20 committee's recommendations.
That working group issued its 21
. report just about a year ago and they recommended that NRC
+
22-be'the organization to regulate the Department ~of Energy
'23 nuclear facilities.
'24 On a separate' track, NRC was, in 1996, undergoing-25 a strategic: reassessment 1and re-baselining-of the agency
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activities.
That was a collection of direction-setting
(}
2 issue papers on quite a variety of subjects, including high 3
level waste, low level waste, and there was one on external 4
regulation of DOE.
That was affectionately known as DSI II, 5
and the issue there was what options were there on taking a 6
position on whether NRC should regulate DOE.
7 Those papers were published in September of '96.
8 The Commission's tentative position at that time was to 9
remain neutral.
That has basically been the NRC's position 10 from day one, not to get into the political debate about 11 external regulation.
12 The public comments received on DSI II were 13 strongly in favor of NRC seeking regulatory jurisdiction.
14 Then in December of '96, Secretary O' Leary announced her
()
15 decision that she would be seeking legislative authority for 16 NRC to regulate the DOE nuclear facilities.
17 In a March 28, 1997 staff requirements memorandum 18 addressing DSI II, the Commission endorsed the proposal to 19 seek regulatory authority provided that there was a clear 20 Congressional mandate and an adequate budget to angage in 21 that activity, and the commission directed the staff to form R22 a task force to sort through over 20 technical policy and 23 procedural issues that need to be thought through in 24 justifying any proposed legis?.ative mandate.
25 In March, we did form a task force chaired by Carl
(} -
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113 1-Paperiello,-and we started to look into this host of issues 2
ranging from Price, Anderson would remain in effect to the 3
role of states, what about cafeguardt, and-security, and 4
issues like that.
5 In June of 1997, Chairman Jackson met with 6-Secretary Pena and they discussed how to approach this, and 7
the agreement was that we would examine this issue through a 8
. series of pilot projects in which we would go out and 9
simulate regulation at a set of DOE nuclear facilities to
,10 gather real world information on the value added of external 11-regulation.
12 Heretofore, it's basically been people sitting in 13 their offices sorting through the issues, and this time it 14 wac decided to get.out into the field, see what's there and 15 see what might have to be done if NRC were to regulate.
16 Benefits that people have identified over the 17 years of external regu? ation have been that it would bring 18 about greater discipline and accountability -- who would be 19 in charge and who do you see if something is going wrong.
20 There is a thought that with NRC's regulation 21 being a very open process of public meetings, notices,
-22 opportunity for hearings, that there would be enhanced 23 credibility and openness in the DOE activities.
NRC 24 regulation would probably bring about a greater stability 25_
-and predictability.
(
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114 l-1 With NRC, there is one vacancy at the Commission 2
level created each year, so it's a -- mathematically, that's 1
3 a 20 percent change per year.
I think we are into our fitth i
4 executive director for operations, although not a political q
appointee, but we have had five EDOs in'the 22 years we have 5
6 been in existence.
So it's small' changes at a time, 7
stability at the EDO level.
There is a tremendous amount of 8
stability in the NRC program.
9 Further, we tend to apply cost-benefit' analyses in
+
10 making the decisions, and we do this -- can do thia on an i
11 individual site basis.
All of this would be expected to 12 lead to enhanced safety at the facilities, and DOE agrees r
13 with that statement.
l 14 One of the first things that we did on forming the 15 two task force, one within DOE, one within NRC, was to 16 c'evelep a memorandum of understanding.
After several months 17 of interactions between the two agencies, that memorandum of 18 understanding was signed on November the 21st by Secretary 19-Pena and by Chairman Jackson.
20 The MOU focuses on the pilot program, which I'll
~21 be getting into shortly, what the objectives of that pilot 22 program would be, the scope of the pilot program and the --a 23
- stakeholder plan for involving other interested individuals.-
24
_On the scope of the pilot, _there was early 25
. agreement that for FY '98, we would engage in no more than
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115
-1 three pilot projects, and that those pilot projects would be Il 2
drawn from either the nuclear energy component of DOB, the V
3 energy research component or environmental management 4
component.
5 In essence, we're ta).ing a rather cautious and 6
deliberate approach to this.
DOE is engaged in activities 7
that we have little regulatory experience in.
So basically 8
what we have been doing is looking for facilities that are 9
current to existing NRC -- similar to current NRC licensees, 10 facilities where our existing regulations-could be applied 11 with some flexibility, facilities that would likely meet our 12 standards, and, of course, we would hope that any facilities 13 in the pilot would be willing to engage in that activity.
14 Finally, we wanted facilities that would be in (Q_,/
15 existence for a long period of time or new facilities, the 16 thought being there is that if -- for those facilities in 17
-the DOE complex that are going out of existence in the next 18 few years, it didn't make a whole lot of sense to spend a 19 lot of time trying to impose a regulatory structure, a new 20 regulatory structure on them just to have them disappear 21 within a few years.
Rocky Flats would be an example of 22 that, which is clearly moving away from its former mission.
23 This was the plan or is the plan for FY '98.
The 24 thought is, for FY '99, to bite off a greater challenge, 25 take on facilities that we are less familiar with and see I)
ANN RILEY & ASSOCIATES, LTD.
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116 1
how flexible our program could be.
()
2 As I said, the memorandum of understanding 3
identifies about eight objectives of the pilot program..
4 First and foremost would be -- the overall fundamental 5
objective would be.to reach a judgment on whether it is t
6 desirable for NRC to regulate DOE.
l 7
To' determine that, we would first propose to see
~8 what the value added would be with NRC regulation.
We are 9
testing various-regulatory approaches that could be used in i
10 regulating these facilities.
For example, at Lawrence r
.11' Berkeley, we are looking at how we could apply risk-informed l
12 performance-based concepts in that program.
13 We hope tc determine the status of a diverse set 14 of DOE facilities with regard to where they would stand in l
15 relationship to our existing regulatory program.
Of course, 16 what everyone is interested in, we would want to know what 17 are the costs, both to the Department and to NRC and to the 18 facility itself, for having external regulation.
19
.Another objective would be to evaluate alternative 20 regulatory relationships in this arena.
There, the issue is 21 would NRC regulate'the department itself or would it 22 regulate the operator of the facility, the MNO, or NRC 23 regulate both.
That's a live question and we need to answer I
24
-it by the end of the program.
25 There will be issues in transitioning to a l
t
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- regulatory program, and we'need to bs' aware of those and be j
()
2 prepared to address them.
Of course, there would be need 3
for legislation.
There are a variety of statutes that
)
~
4 direct NRC and limit NRC's authority, and we need to sort i
5 through-those to find out what all proposals we could need 6
to put forth to Congress. ~There's a lot of stakeholder 7
interest' existing at the DOE facilities and we would need to 0,
sort through what kind of a stakeholder plan would we have if we were the regulator.
x10
_ Of course, one of our objectives always in 11 regulating any entity is not to interfere with any ongoing i
12 safety or safeguards program, and we are keenly aware of 13
-that, to not interfere with DOE operations.
14_
On the approach.to simulating regulations at these i
()
E 15 facilities, we're looking at them as sort of like a joirt 16 self-assessment.
We invite the Department to accompany us 17 at the facilities.
We invita the facility itself to 18 participate;and we are inviting state radiation protection 19 program representatives to engage in this pilot program.
20 We're using the pre-licensing model as we go to
-21 these facilities.
There, we inform them of generally what 22__
our expectations are.
We try to find an existing license-that closely matches what the activities are at the
~
-24 facility.
We talk to them - -what if?
Could they_do it 12 5 this way?- Could they do it that uay?
And then we're also L ANN RILEY & ASSOCIATES, LTD. ' Court Reporters ~ 1250 I-Street,-N.W., Suite 300 Washington,-D.C. 20005' (202) 842-0034 'g,aiv. g W-, ,y7e-71-- .e -my p -e,-,g eg w_ w g qr me-.my5w wggs,i%,-sy. 4msw'g-7
118 1 .using some of our inspection modules, recognizing, though, 'i 2-that because we have no jurisdiction over these facilities, - 1 3 there will be no enforcement action taken at anything we 4 find at t+e facility. l 5 An inceresting thing that we are exploring is what 6 to do about accelerators. As you know, Lawrence-Berkeley -7' National Lab is the first pilot project that we've engaged 8 in. They're world class in cyclotrons and accelerators. 9 You know, should NRC become involved with them? 10 Currently, our regulatory reach has always been 11 limited to materials that have some connection'to the 12 - neutron chain reaction, and we-have never engaged in ~ 13= regulation of radium or other accelerator-produced 14 radionuclides. But their accelerators, cyclotrons are a 15 significant potential source of radiation exposure, 16 -primarily to the workers, and we're examining what, if 17 anything, we should do in regulatory space with those. 18 By way_of.a-stakeholder plan, we are trying to 19 involve as many interested parties as possible. For 20 example, for the Lawrence-Berkeley visit that <e had last 21 week, the Department sent out 600 invitations to known 22 interested parties to participate in the stakeholder 23 meeting. - 2 4.. So we are! outreaching. There is a lot of interest 25 in.this program, and the Office of~ManagementJ and Budget, y ANN RILEY & ASSOCIATES, LTD. Court Reporters -1250 I Street, N.W., Suite 300
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119 1 the House and Senate have a lot of interest in what's going () 2 on. So we need to keep as many people as possible informed 3 of what we're doing and where we're going. 4 For the individual pilot projects, 5 Lawrence-Berkeley is the first. It is a ccTplex facilit/ 6 that is similar to a large university. So what we are doing 7 with them is we have given Lawrence-Berkeley one of the 8 tniversity licenses held by our Region I office. We're 9 using inspection approaches that we use at large 10 universities and just applying that to Lawrence-Berkeley. 11 The second pilot program to begin in_early 1999 -- 12 or 1998 or the spring of 1998 -- we're still trying to work 13 out that schedule -- that second one will be the Radio 14 Chemical Engineering Development Center at Oak Ridge. It's () 15 part of the Oak Ridge National Laboratory. It's off the 16 -main campus adjacent to the high flux isotope ?- cear. 17 REDC comprises two large hot cells, hot cells 18 within hot cells. They are ext 1.cting very, very heavy 19 elements, trans-plutonium ones that they take targets that 20 could start out as curium and produce those radionuclides 21 that were not on the periodic chart when I was in school 22 --:urium, berkelium, nobelium, seaborgium--- and what thia 23-will do is test the flexibility of Part 30 -- all of these 24 are not under Part 70, so they turn out to be byproduct 25-materials. They involve assemblies that. design and h ANN RILEY & ASSOCIATES, LTD. \\/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, ID. C. 20005 (202) 842-0034
120 i fabrication the likes of which we have not seen befora. [Vl 2 It's basically microchemistry, separating out these very 3 small quantities of heavy elements. 4-So we'll see, you know, how flexible we can be in 5 approaching this somewhat different facility. We do 6 currently license some hot cell facilities somewhat similar 7 to this, but it's the radionuclides that we have very little 8 experience with and we'll be testing our capabilities. 9 The thi2d facility was recently selected. It's a 10 spent fuel storage installation planned to be constructed at 11 the Savannah River site. The thought there is that they 12 would be -- DOE would be storing aluminum clad fuels, which 13 we have little experience with, so we'll be testing the 14 flexibility of part 72. There may be other novel fuels that () 15 we have not regulated going into this facility. 16 DOE's hope is that we engage them in this pilot 17 project in the spring of 1998, spend about five to six 18 months simulating regulation as they go through ths 19 preparation of a request for a proposal. That request for a 20 proposal would be designed and the construction schedule and 21 the like, and DOE's hope is that through these interactions, 22 we would influence the RFP and the characteristics that 23 would be called for in the RFP such that once the facility 24 is designed and constructed, that it would be licensable, 25 So they want the regulator along their side the entire step / ANN RILEY & ASSOCIATES, LTD. \\/ Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
121 1 of the way. () 2 .It's also-consistent with FY '98 appropriations 3 language that this directs DOE to have all new facilities i 4 constructed after the year 2000 to be in compliance with NRC 5 -regulations. Congress didn't say we would regulate them, 6: but that they have to design their facilities in accordance 7 with NRC regulations. n 8-Let's see. In FY '97, we had no money-9 appropriated for this activity, so we negotiated with the l J 10 Department of Energy an interagency agreement whereby they -11 would reimburse us for all of our expenses in FY '97. Very 17~ late in the FY '98 budget cycle on the Hill, the House 'l -13 Appropriations' appropriated a million dollars for this pilot 14 program directly to NRC. The Senate recognized the effort () 15 in conference. Congress actually appropriated $1 million 16 for the FY'898 budget. 17 That $1 million, we are saying supports about six 181 FTE within the agency. That allows for the extensive travel 19 'that will be involved'in the pilot program and it allows for 20 the potential for some contractual support. The budget now. 21 for FY '97 is before OMB and we'll have to see how that 22 plays _out. 23-
- The assumption that we're now operating on is that 24-we would have about-five additional _ pilots in FY '99 that we 25_
would. submit: proposed -- I'm sorry -- submit proposed- ((~ - lAVNLRILEY:& ASSOCIATES, LTD.- \\ Court Reporters i '1250LI-Street, N.W.,'-Suite 300 Washington, D.C. 20005 (202) 842-0034-9
122 1 legislation to regulate a class of DOE facilities in the /~'T 2 spring of calendar. year '98. U 3: This is somewhat different than what is in the 4 memorandum of understanding. The memorandum of 5 understanding said that after two years, if justified, the' f 6- -two agencies would prepare proposed legislation, i 7 In transmitting the MOU, the signed MOU to DOE, 8 the Commission's letter said that the commission prefers to 9 re-look at the MOU after the Lawrence-Berkeley pilot 10 program, which is scheduled to be finished in April of this t il year, a~ final report in April. 'Its Comminsion proposed that 12 -we re-visit the MOU at that time to determine whether we 13 should seek at that point in time legislation to regulate a 14 class of facilities like research-oriented national () 15 laboratories. So that's a possible outcome. 16 Overall, we're thinking that in calendar year '99, 17 we would submit the broad legislation to have oversight 18 responsibility for all but the defense program facilities. 19 So that's about where it stands. I can give you 20 some brief remarks on what we found at Lawrence-Berkeley. -21 Again,.they're the first pilot. We spent all of last week 22 out there with-three inspectors who were licensed reviewers 23. andia couple of policy people. 24 First, we-found no significant safety issues,- 25. Lawrence-Berkeley-has a very impressive program. We-think [') ANN R'%EY & ASSOCIATES,. LTD. \\~/- CourtLReporters .1250 I Street, U.W., SuiteL300. Washington, D.C. 20005 (202).842-0034 -~ a.
123 1 it is licensable, that it wouldn't take much by way of 2 change to be licensable. There are no fundamental changes () 3 that would have to be made. 4 The lniversity of California has volunteered to 5 prepare an application for a license. That's under the 6 concept that if you -- if you look at like Part 30 and Part 7 70, they're very general regulations requiring the 8 submission of an application and requiring addressing some 9 issues. 10 The way the regulatory program evolves is through 11 the regulator asking questions about what do you mean by 12 having a procedure, what do you mean by having an 13 anvironmental monitoring program? So thruugh these 14 interactions, round 1 questions, round 2 questions, a number () of commitments are made by the applicant, and it's through 15 16 those commitments, through those letters that are referenced 17 in the license itself where you flesh out what the real 18 regulatory program is and what is really inspectable, and 19 the University of California has volunteered to go through 20 thia process. 21 On our side, we're preparing what we call a 22 mock 'icense and sharing that with the State of California 23 and Lawrence Berkeley to see what the program would look 24 like to get a much better feel for what the cost would be if 25 we were to regulate the laboratory. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
124 1-There_is-an issue. _The University of California () 2 prefers to have the state regulate the laboratory. Their 3 thought there is that if the state were to do it,_the state 4-could do the-Atomic Energy Act materials and the 5 accelerators. 6 Sotwo need to sort through that. Eminent domain 7-has prevented us from relinquishing jurisdiction over 8 Veterans Administration, over the Army, the Air Force. Jul 9-example of how,-you know, the state regulating part of a 10 facility like the -- the university itself, the campus holds 11 _a_ license from the State of California. It's when you get 12 up into the national laboratory space, would that be a 13-federal license.or an extension of the state license. 14 That's what they're looking at. () 15 But we have experience in having state regulate 16 one part and federal-regulating another, and it's -- like at 17 UCLA. UCLA has a state license to engage in medical 18 practice and other things. Right across the street from 119 that campus is a Veterans Administration Hospital which 20 holds a-federal license, and many of the physicians walk ' back and forth from, you know,_ one-hospital to another, and 221 -that-doesn't seem to cause confusion. 23 But it is a major policy issue to be decided at 24 the Commission and Congressional levels. ,I have no idea how 25 that's going =to~come out, ANN RILEY'&-ASSOCIATES, LTD. 's-Court Reporters- .1250 I_ Street, N.W., Suite 300 -Washington, D.C. 20005
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125l 1 Let's see. Well, we had a stakeholders' meeting j ( '2 last Thursday. As I mentioned, over 600 letters of 3 invitation were sent out. There are some very active I 4 interested groups in the Berkeley area. They have 5 considerable concerns about the national tritium labelling 6 facility, which is at the Lawrence Berkeley site, and there 7 are come other activities that the university appears to be 8 getting into that the citizens groups are very concerned -9 about. l 10 It turned out about 50 individuals nhowed up to 11-the stakeholders meeting. It went for two hours in the 12 evening, and they had very, very interesting, knowledgeable 13 questions. I think it was a fair exchange, and I think the 14 meeting went quite well, but it was rather interesting to \\ 15 see that level of local interest in what was going on. 16 MR. FAIRHURST: Largely university employees, the 17 stakeholders? Largely people who came from the university 18 community? 19 MR. AUSTIN: No. Citizens that live in Berkeley. 20 There are three or four organizations that routinely 21 interact with the laboratory, Physicians for Sound Energy, 22 some name like that. There were people from Lawrence 23 Livermore Laboratory, Los Alamos National' Laboratory. There 24 .were people from our Walnut Creek office, which is being 25 shut down, and a fair. number from Lawrence Berkeley Lab [ ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005-(202) 842-0034
126 l' itself and the finiversity of California's president's i 2 office. That shows you the level of interest out there in 3 this program. 4 We anticipate taking another look at our work plan 5 that incorporates all the issues, take a look at what we 6 found last week at the laboratory, revise the work plan and 7 go back out in January, the week of January 12th, to take a-8 greater in-depth look at some of the areas and to hopefully 9 wrap up some loose ends and then go about writing our report 10 to the Commission and to the secretary in April of 1998, and 11 we anticipate starting RADC within a couple of months. 12 CHAIRMAll GARRICK: John, are all the pilot 13 projects operating facilities? 14 MR. AUSTIN: Yes. 15 Cllt.IRMAN GARRICK: Is there any plan to do a pilot 16 on a clean-up operation? 17 MR. AUSTIN: Not at this point in time. We think 18 that the clean-up operations are probably already under an 19 agreement with EPA, either RCRA or CERCLA agreement, being 20 overseen by EPA or its counterpart in the state. 21 In some cases, there are tri-party agreements 22 where there are deadlines, tnere are standards incorporated 23 into it, penalties if DOE does not follow through, so we 24 prefer not to upset those kinds of arrangements. 25 At this point, we have not put on the table-any / ANN RILEY & ASSOCIATES, LTD. b Court Reporters 1250 I Street, N,W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l
127 1- ' clean-up operation, but to get at the difficulties that we () 2 might' find'if we~got into legacy issues, we have been 3 talking to the Department about Argone National Laboratory, 4 ~ which has some burials from years ago to see how that would i 5 work out. 6 CHAIRMAN GARRICKs Of course, some of the clean-up 7 operations can get fairly elaborate from an operational 8 standpoint, requitang new facilities, process facilities, 9 handling facilities and what have you. ] 1-0 MR. AUSTIN: There is at least one case already in 11 house on that, and that's TWRS, the Tank Waste Remediation i 12 something or other -- 13 CHAIRMAN GARRICK: System. f 14 -MR. AUSTIN: Sybtem. Thank you. I know acronyms, l () 15 but I don't know what they -- how you spell them out. We 16 are engaged in'that. That is like a clean-up activity. i 17 '4 AIRMAN GARRICK: That was the one I was thinking 18~ of. 19 MR. AUSTIN: Yes. Now, that is -- we on the task 20 force are trying to stay aware of what's going on in that 21-arena. There will be a similar activity I believe.down at l 22 - Savannah River on their tanks. There is a planned mixed 23-oxide facility that -- for. excess plutonium that would be 24-mixed with' uranium oxideLto-prepare mixed oxide fuel for - 25: - commercial reactors, _ That's.not within the pilot. Those 'Y CJL ANN RILEY & ASSOCIATES, LTD. Court Reporters 1250 I-Street,-N.W., Suite 300 Washington, D.C. 20005J (202) 842-0034 i-9,.~e v.,,+v-m +.* s--g',- ,,,,,-.,--,,w-, ,w' ,,-w-- y ,w,--* r, p -r ,w +12--,,----r, e
= 128 1 are straightforward regulatory programs, not like a 2 laboratory where you're testing alternative concepts,. i 3 alternative relationships, although there are things that -4 could be learned across the board in all of these, including 5 the enrichment facilities. 6 So we on the task force are staying aware of 7 _ what's going on at TWRS, at the planned MOX facility. 8 CHAIRMAN GARRICK: You said a little while ago .9 that where there -- where regulators or-regulation is in 10 effect, it sounded like that you wouldn't interfere with 11-those. So it sounds like that way down in the future, that 12 DOE will' continue to have multiple regulators. I'm thinking 13 of such facilities as the Waste Isolation Pilot Plant, for 14 example, which has been certified by the EPA. Is it pretty 15 well assumed now that NRC's role, if this were to go 16 forward, it would be restricted or limited? 17 MR. AUSTIN: I really think it's one step at a 18' time. -Let's conclude Lawrence Berkeley, let's see what 19 happens at revisiting the issue, should we seek legislative 20 _ authority over research-oriented national labs. There -- I 21 -think on DOE's side, they remind us that there is a lot of 22: skepticism'about what external regulation would be. There 23 are some within the' department that are very concerned that 24 ~if NRC were to regulate them,-we would break the bank. '25 ..Those'that are skeptical of the viability ofthis approach a ANN RILEY & ASSOCIATES, LTD. ^ - Court Reporters 1250-I Street, N.W., Suite 300= Washington, D.C.:20005_ -(202)-842-0034 -.-.u..
129 1 use the enrichment plants as an example of what they call a () ~ 2 very high price tag for getting those facilities into a 3 certified point, but they don't -- or appear not to 4 recognize.that most of those costs would have been necessary 5 to-come into compliance with existing DOE requirements, not 6 anything new from NRC. 7-And there_is also not a well known recognition of 8-the difference between a facility license and a materials 9 license. In materials licenses, like at universities, it is 10 a possession and use. You can possess and use radioactive -- ;11 material in a Butler Building if you have access controls,- 12 so it doesn't require, you know, major seismic upgrades or 13 things like that. l j 14 So what we need to do is understand the cost for a i () 15 class of facilities and then, if justified, go forward for 16: that legislative authority for that class. -17 How far it would go in the future is-largely 18 dependent on how well we do. Are we overly restrictive? Is 19 there no value added? So it will be a stop at a time. 20 MR. HORNBERGERr Just sort of a follow-up. You H21 mentioned, John,.that -- I think you said calendar '99 in ~ _22 the scheme of' things, you would go forward with legislation 23' to basically-. handle everything except_ defense programs, .24 -Now, beyond '99, do you--see the: likelihood that 25 you wouldfalso* regulate _ defense aites? Are they beyond the-- ANN RILEY & ASSOCIATES, LTD. Court Reporters-L12501I-Street, N.W., Suite 300-Washington, D.C. 20005 ^(202) - 842-0034-
130 1 pale? f~)') 2 MR.-AUSTIN: My crystal ball is very, very fuzzy t 3 when it-gets out that far. Congress in the FY '98 4 appropriations directed the Defense Nuclear Facilities 5 Safety Board to engage in a study on how their jurisdiction 6 may be broadened, how it may be lessened..As I recall, 7 there are probably about 20 different subjects'that the 8 board is going to have to address in a study over the next 9 six to twelve months. 10 CRAIRMAN GARRICK: Charles, Ray, any questions? 11 You-probably know something about that--facility at Oak 12-Ridge. -Ray? 13 MR. WYMER: Where should we look? Where are the 14 skeletons buriedc Under the floor. () 15 (Laughter.] 16 MR. WYMER: A pipe broke. 17 (Laughter.) -18 MR.-WYMER: No, I don't have anything specific. 19 I'll be very interested, though; to follow the details once 20 you get into it since I, in fact, had that facility under my 21 purview at one time. 22-MR.-AUSTIN: We may be consulting with you. -23 (Laughter.) 24-CRAIRMAN GARRICK: Any other questions? Any i 25-questions.from the-staff? O ANN RILEY & ASSOCIATES, LTD, Court. Reporters-1250 I Street,1N.W.;-Suite 300 Washington, D.C. 20005 (202) 842-0034:
l 131 l l' Were you going to report on any other activities 2 such as the status of -- I guess we're going to hear about 3 Yucca Mountain tomorrow, so -- j 4 MR. AUSTIN: The only thing I have thought about 5 for the last eight months is external regulation, DOE. 6 CHAIRMAN GARRICK1 Right. 7 MR. AUSTIN: -So I lost a little touch of the high 8 level waste program. 9 CHAIRMAN GARRICK: Okay. Well, thank you very. i 10 much. That was very informative and we're glad to see as l {11_ -much progress as there has been, ar.a we look forward to l 12 hearing from you again soon. Thank you. l 13 The next topic is something that we would like to 14 do mere often, is give the members of the staff an 15-opportunity to educate the committee on selected topics, and 16 today, we're going to hear a little bit about licensing f 17 requirements for land disposal of radioactive waste. The 18 ACNW staff member that's going to lead us through this 19 -discussion is Andy Campbell. 20 I guess, because you are preparing a comprehensive 21 set of minutes for thin presentation, that we need not have 22' it recorded. Is that correct? 23-MR. MAJOR: Unless Andy wants it -- do you want it 24 ' recorded? 25 CHAIRMAN _GARRICK: Do you_want a transcript, Andy? t ANN RILEY-& ASSOCIATES, LTD. f Court Reporters 1250 I Street, N.W., Suite 300 Washington,.D.C. 20005 (202) 842-0034 .v ,,--e.+- ,,w w,',, -a.. -v ,Lr-., s,-,, e, ---,..,--w 1.g.---
m__.___.______.-______..___.._____...___.. 132 s 1 So I think, with that, we can terminate'the l 2 recording activities for the-balance of today. 3 (Whereupon at 1:45 p.m., the meeting was 4 recessed, to reconvene at 8:35 a.m., Wednesday, DecernL 2r 17, I 5 1997.] - e 6 -7 i 8 9 10 11 12 13 I 14 t 15 P 16 17 18 19 20 21
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'23 24-25-k . ANN RILEY & ASSOCIATES, LTD. Court-Reporters '1250 I Street, N.W., Suite 300 Washington; D.C. 20005. i (202) 842-0034. s 5 4,.-_,
REPORTER'S CERTIFICATE This is to certify that the attached proceedings (m) before the United States Nuclear Regulatory Commission in the matter of: NAME OF PROCEEDING: 97TH ADVISORY COMMITTEE ON NUCLEAR WASTE (ACNW) MBETING DOCKET NUMBER: PLACE OF PROCEEDING: ROCKVILLE, MD were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear r Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court (- '(,,/ reporting company, and that the transcript is a true and accurate record of the foregeing proceedings. \\ ~',nC4% 1 0 C/ ( Jon Hundley Official Reporter Ann Riley & Associates, Ltd. O}}