108th ACNW Meeting U.S. Nuclear Regulatory Commission, March 24, 1999
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
***
108TH ADVISORY COMMITTEE ON NUCLEAR WASTE
(ACNW)
Nuclear Regulatory Commission
Room 2B3
Two White Flint North
11545 Rockville Pike
Rockville, Maryland
Wednesday, March 24, 1999
The above-entitled meeting, commenced, pursuant to notice at
8:31 a.m.
MEMBERS PRESENT:
DR. JOHN B. GARRICK, Chairman, ACNW
DR. GEORGE W. HORNBERGER, Vice Chairman, ACNW
DR. CHARLES FAIRHURST, Member, ACNW
DR. RAYMOND G. WYMER, Member, ACNW. P R O C E E D I N G S
[8:31 a.m.]
DR. GARRICK: Good morning. I believe it's Wednesday, March
24th, 1999. Our meeting will now come to order.
This is the second day of the 108th meeting of the Advisory
Committee on Nuclear Waste. My name is John Garrick, Chairman, ACNW.
Other members of the committee include George Hornberger, Ray Wymer and
Charles Fairhurst.
We will re-welcome and re-introduce our two consultants, Dr.
Otto Raabe and Dr. Kim Kearfott -- and we also continue to welcome the
member of our sister company and that is the Chairman of our sister
company, Dr. Dana Powers.
Today the committee will continue our discussions on low
levels of ionizing radiation and allow the public to hear their views on
the presentations we heard yesterday. We have some other business to
do. We will meet with John Greeves, NRC's Director, Division of Waste
Management, to discuss developments at Yucca Mountain, rules and
guidance under development, resources and other sources of mutual
interest. We will review progress on the development of a clearance
rule for materials and equipment having residual radioactive
contamination, and we will review the status of the Decommissioning
Standard Review Plan.
Mr. Howard Larson is the Designated Federal Official for the
initial portion of today's meeting and as usual this meeting is being
conducted in accordance with the provisions of the Federal Advisory
Committee Act.
Aside from the announcements we made yesterday regarding
people who wish to make remarks and comments, we have received no other
written statements or requests from members of the public regarding
today's session.
Should anyone wish to address the committee, please make
your wishes known to some member of the Staff and as usual we appeal to
you because of the need for recording your valuable words to use a
microphone, identify yourself, and speak with clarity and volume so that
we can hear your message.
So I think where we are today we are going to continue our
discussion, continue to hear from selected numbers of people and
hopefully advance this thing to a point where we have a basis for
developing some sort of a letter or report for the Commission, and with
that I will turn it back over to our lead member on this subject, Ray
Wymer.
DR. WYMER: Thank you, John. I think the appropriate way to
start this out for the benefit of the people who may -- there may be a
few -- who weren't here yesterday, to state what the purpose of this
meeting is, what we hope to accomplish.
The purpose of the meeting is to update the Advisory
Committee on Nuclear Waste with respect to the research and some of the
debate regarding the linear non-threshold hypothesis so that the
Advisory Committee can advise the Nuclear Regulatory Commission on
actions related to the LNT as applied to radiation risk of low level
ionizing radiation.
That is our purpose and in addition we wanted to maintain a
high level of visibility of this very important topic in the Commission
and in the public at large because we think it is a very important
issue, one with profound financial implications as well as health
implications.
This morning we will continue with discussion from the
audience with respect to their points of view and their interests and
points they want to make in this area of LNT and following up on the
procedure of yesterday, I want to turn it over to Michael Halus, who was
facilitating yesterday's panel discussion and who will also facilitate
the discussions this morning. Mike?
MR. HALUS: To reidentify the purpose for this particular
portion of the meeting, that is, the panel discussion, the purpose is to
further explore the issues associated with LNT with a view towards
searching for gaps in the research and identify further actions for
consideration and recommendation to the Commission.
We have invited people to make presentations on it. I would
ask people to constrain their remarks to a 20-minute time period so
everyone who chooses to present will have time to do that -- so is there
anyone in the audience who would like to make a presentation? They are
certainly welcome to do that.
Who would like to go first?
MR. ROCKWELL: Theodore Rockwell.
DR. GARRICK: Ted, you may want to go up here -- we can see
your wonderful physique better that way.
MR. ROCKWELL: Thanks. First of all, I want to say that Ted
Quinn, who is the President of American Nuclear Society wanted very much
to be here and he called me at midnight last night. He was still trying
to get a later flight out to Rochester, which I guess there aren't a lot
of them, and he didn't make it, but he asked me to convey the concern of
the American Nuclear Society on the importance of this issue and the
tremendous burden that it puts on nuclear technology to have to concern
itself with these minuscule levels and defend the fact when we are in a
position of saying we don't know whether we are killing people at one or
two MR per year.
Incidentally, I got an e-mail last night from Zbignieu
Jaworowski of the Polish Central Laboratory in Radiation and he told me
the 48th UNSCEAR session will be held in Vienna from 12-16 April. I am
preparing myself for it 100 percent of my time and he is -- they are
going to consider Cohen's work is specifically on the thing and other
epidemiological subjects relating to LNT and the whole basis for the
assumption of accumulating dose and so forth, and he has got a paper
here that he wants us to look over that he wants to send out to the
committee members ahead of time for their consideration on this whole
business of collecting LNT doses and pointing out how absurd it is, and
the way the thing is worded now and the way they are doing it is that
they want the sum of all annual doses over all the years in which
exposures continue over infinite time to account for exposures occurring
to all future time from the average individual dose over all
generations.
He plays this thing out all the way back to homo erectus and
homo habilis --
[Laughter.]
MR. ROCKWELL: -- and points out that the billions and
billions of manrem that have been built up over that situation and the
.00000 contribution of anything we can do, and says for gosh sake,
fellas, let's knock this off.
I hope that any consideration you give you will recognize
that you are not alone in this thing. There are a lot of people -- the
concern is building up that this is -- I mean there comes a time when
you have to say that the thing has reached a ridiculous point.
The other question -- this contract for this report, as I
understand, was under Regulatory Research, is that right, John?
DR. GARRICK: The NCRP --
MS. THOMAS: Yes, the NCRP 1.6 was through Research.
MR. ROCKWELL: Yes. Is there anyone here from Research that
is responsible for this report? Has anyone been here to say whether --
MS. THOMAS: Shlomo?
DR. YANIV: I know that Vince Holahan --
MS. THOMAS: Yes, Vince Holahan is on military assignment at
this point in time. He was the PM for this project.
MR. ROCKWELL: Well, do we know whether the people who paid
for this report feel that it answers the concerns that they had that
were expressed in the '96 meeting that the thing would consider all of
the data and that the questions that have been raised in the past have
been satisfactorily answered and so forth?
Is anybody here to answer that question?
DR. YANIV: I can answer my personal --
MS. THOMAS: Shlomo?
DR. GARRICK: Use a microphone.
DR. YANIV: My name is Shlomo Yaniv and I am with the Office
of Research. Now the comments that I am going to make at this point are
my personal ones, having read the draft report. I have not prepared any
remarks.
I was impressed by the scientific quality of the report, the
depths of analysis and I consider the report to be a report on the state
of the art of science in all aspects of radiobiology from molecular to
human epidemiology including animal research, et cetera.
Obviously it cannot answer all the questions that we would
like to have the answer for reasons that have to do with the nature of
the science and the state of the science, but it is an extremely good
picture of the state of the knowledge for the professional.
It is not an easy read and my personal opinion, that the
conclusions drawn in the draft report are correct.
MR. ROCKWELL: Are you satisfied that the concerns that were
raised three years ago by this committee and others that have come in
where specific questions were raised that this is not valid because,
this is not valid correctly handled -- are you satisfied that all those
concerns that have been specifically raised on the record have been
handled?
DR. YANIV: As I said, I have not prepared, I have not
reviewed anything prior to our conversation and I am not familiar with
the specifics that you right now ask or maybe don't remember at the
moment so I cannot answer that in an affirmative nor negative.
MR. ROCKWELL: But before the report is finally approved for
issuance, is anyone going to look over -- these concerns have been
presented before to this committee, to the NCRP. People have gotten up
and testified. Matter of fact, we have had concerns expressed to us
that we have heard all this stuff before.
You have. The question is has it been responded to and if
it is not going to be responded to now, do you plan to go over these
things and assure yourself --
DR. YANIV: I cannot answer that question. I am not the
Project Manager. I am a Staff member and as I said I am expressing at
this point my personal opinion. You are getting into policy which I
cannot answer.
MR. ROCKWELL: John, I assume that that will be addressed in
your letter?
DR. GARRICK: Well, we are going to review everything we
have heard and it will be the basis for our letter, that's right.
MR. ROCKWELL: Okay. Well, let me turn this over to Jim
Muckerheide or to Myron -- either one -- whichever of you guys want
to -- what we want to do is to try to make clear the nature of the
concerns that we have and specifically why -- I mean yesterday we only
had minutes and what we said was these things, these comments that we
have made have not been concerned and Arthur Upton got up and said sure
they have, and then he went on to the next topic.
We would like to get more specific as to why we feel that
these have not been raised, why they are substantive, and why they
should be approached.
MR. HALUS: For timekeeping purposes, we will go ahead and
start the 20 minute time period with the new speaker.
MR. MUCKERHEIDE: I wasn't so much anticipating making a
presentation as pointing out some of the questions that we would like to
pursue. In responding to the presentation yesterday by Dr. Upton, it
seemed to me that we have the classic example of having a number of
slides that represent the linear response that you get when you hit
cells with radiation, and they are cells in petri dishes that have no
biological systems that are immune-response, et cetera, and so you bring
out that data and say, see, it is a linear response. It doesn't include
cells that show non-linear responses.
A lot of the slides start at a relatively high dose, even if
it is only 1 rem per day, which is very low dose in high dose studies,
but there is no data that goes below the 1 rem per day. And so you end
up with this presentation that says here is another straight line.
In addition, the data that shows cell and chromosome
effects, we know from the radiation workers in the U.K. that have been
followed from the wind scale fire, the high dose group, they can see
chromosome effects in that population. There is no associated health
effects. That is true in general, high doses are going to have more
chromosome aberrations, but, in general, a chromosome aberration is a
dead end and it doesn't necessarily mean there are health effects. In
fact, in animals that show beneficial effects, you can see excess
chromosome aberrations.
So the fact that they presented a lot of data from the
biology literature that shows these kinds of effects, and yet it still
comes out with the same old straight line selected data continues to
exist.
He made a statement about double-strand breaks as being
normal activity is one in 25 years or something like that, on one of the
slides. Unfortunately, we didn't get any handouts, so I am not sure
that I remember this accurately, but I was thunderstruck at that number.
It is clearly not part of what biology represents, although radiation
has a higher percentage of double-strand breaks than single-strand
breaks compared to normal biological metabolism, it is certainly nothing
like one per 25 years. Double-strand breaks are frequent in normal
metabolism and representing that they aren't is clearly contrary to the
current knowledge of biology.
We had a number of presentations that showed responses from
neutrons, et cetera. That is, of course, not really relevant to
anything that we care about in low dose radiation response.
There was a statement I thought that was very instructive
about radium-226 as being the one thing we really know has a threshold,
and, of course, we have all known since the late '60s, early '70s, that
the threshold is about 1000r, and in this case we have radium-226 as a
threshold. I was interested in asking Dr. Pushkin about why the fact
that we already have radium-226 limits that are 125,000 times lower than
that threshold, why they are now still going through a rulemaking to
further reduce radium-226 limits in drinking water and why we went
through a whole exercise with radium-226 groundwater contamination in
New Jersey, with fears that were going to be damaging people because
they had more than 5 picocuries per liter.
The State of Wisconsin, the high dose, where the high
concentration area is in Wisconsin, Iowa, et cetera, are going through
now the fact that they may spend additional millions of dollars to deal
with the fact that they have radium in drinking water that is higher
than the limits, and the new limits would add more millions of dollars,
and, yet, in this presentation yesterday, we acknowledged that that is
one of the very specific cases where the linear threshold doesn't apply,
or the linear nonthreshold doesn't apply.
You were going to say --
DR. GARRICK: No, no.
MR. MUCKERHEIDE: Oh, I'm sorry. There was a presentation
on leukemia in the atomic bomb survivor studies that typically ignores
the low dose data point that was left off of one of the 1988 studies and
has consistently in the literature been pointed out that the actual
leukemia data in the lifespan studies is inconsistent with how it was
presented in Shimizu '88.
The fluoroscopy data that was presented ignored the
fluoroscopy study of the Canadian women, except for the high dose group
in one part of the study, but not the other part of the study. It has
been pointed out for years, since Ted Webster pointed it out on
publication of the original article, that the data is highly indicative
of hormetic response for breast cancer. It is also highly indicative of
a response for lung cancer.
It was known at the time of BEIR V, and yet it is the -- in
the actual summary of BEIR V, it is the second most significant study
after the lifespan survivor study in the document in terms of a person
rem year, and is relied on enormously for a straight line that is
generated, has straight line over a low dose decrement of one-third for
the breast cancer rate in that population.
More reference was made to the Cardis study of the U.K.,
U.S. and Canadian workers, a study that basically misrepresents its own
data. The study authors, after having published the study, and finally
gotten some criticism for the fact that they had come out in saying this
shows a linear response, several of the authors refused to make that
statement, yet the NCRP has continued to make it, and even to
characterize it as vindicating the linear model. And in that study, it
is clear that the only one cancer of the couple of dozen that is in
there, in a 1 out of 20 test, has 6 cases of leukemia versus 2.3
expected for greater than 40r dose group, and on the basis of that one
data point, draws a straight line to zero, discounting all of the data
in between. We show no such indication, and, therefore, the Cardis
study, in its own presentation, misrepresented its own data.
And as Myron has always pointed out, as long as you take 1P
values, then you essentially ignore all the data points below the line.
Out of the seven groups, you only have three that are above the line,
and it happens to be that the one at the end is high, so in 15,000
deaths, you have 6 versus 2.3 in a greater than 40 rem dose group, and
now the whole study demonstrates and proves the linear model, and it
gets referenced as though it does. And that has been documented, it is
documented in the Los Alamos Science magazine. It has been documented
in the literature.
I mean it is not as though this is, you know, somebody's
underground railroad, this material was presented to NCRP, and they are
well aware of. It has been presented not just for this report, but
before that. It came out in meetings that we had in '95.
I want to pass over the Cohen data. I did want to make one
point though about the characterization of Cohen's data as though it
were an anomaly and somehow the result of one man's extraordinary
treatment of this data.
If we go back to '87 when Cohen first took a look at
Cumberland County, Pennsylvania, and found that this highest-radon
county in his neighborhood had very low lung cancer rates, and he
compared seven other studies that indicated -- around the world that
indicated similar kinds of results -- those kinds of studies were then
published in a number of places, and so we've really known about this
since before '87 really.
Cohen kind of pulled this together in '87 in the Health
Physics Journal. He did two or three other interim studies, not all of
which just literally led to the 1995 conclusion by the time he had all
of the data that was so dramatic, but a number of studies are included
and all consistently reflecting the same kind of relationship.
But in addition to Cohen, you know, small studies and minor
efforts, but looking at the whole U.S. population all shows the same
relationship. You know, there's a tendency to think well, Cohen went
out and did all these measurements and there may be some self-selection.
Well, last year Bogen at Lawrence Livermore looked at just the EPA's
data on the radon based on the environmental measurements, and those
environmental measurements were correlated with residential radon
concentrations. But if you take the environmental measurements over the
whole U.S. and correlate it with the American Cancer Society's
statistics on lung cancer, and he looked at the women lung cancer
deaths, 1950 to 1954 as another set, but because the women from 40 to 80
years old had 11-percent smoking frequency and 4-percent smoking
frequency in the women 60 to 80 years old, and when he looks at that he
gets another curve just like Cohen's, totally independent in any way,
shape, or form from Cohen's analysis and the way he got his data and the
way he made the analysis.
When Jaeger published and simply said hey, we're going to
take the high-dose States and the low-dose States and see this enormous
discrepancy, and it's very highly statistically significant. Sandquist
at Utah in '96 did a cut at the data just on the EPA regions and looked
at radiation in terms of the EPA regions based on the EPA's own cut at
the radon in the country, and they got the same results. They found
that the lung cancer rate at the highest-dose region was 14 percent of
the EPA predictions, and the lung cancer rate at the lowest-dose region
was 390 percent of the EPA prediction, and that if you take each region
in between it's a consistent relationship.
I mean, this is not an anomalous kind of situation. And yet
BEIR VI itself treats Cohen as a nut on the fringe and misrepresents his
data in the curve and characterizes that in a paragraph to simply say
well, some people would think this might represent that there isn't a
significant effect, and they leave it at that. And then they go about
and they say we do a model that basically draws a straight line and
that's the end of it. And so this whole process continues.
I commented yesterday that Norm Frigario, who I knew in the
seventies, and one of the reasons I got exposed -- no pun intended, I
guess -- to this whole subject was when we were paying attention in '72
to Calvert Cliffs and Appendix I, Appendix D, all the initial efforts
because of the new NEPA standards and writing environmental reports. I
was working for Bechtel at the time.
AEC contracted with Argonne to do a low-dose study
specifically in response to Calvert Cliffs and a court's decision that
you didn't do a good enough job, and as a licensing initiative they made
a contract and Argonne did a study just to say here we have a population
that's exposed to low-dose radiation in the same terms and conditions
that we're concerned about in terms of chronic exposure at low rates,
and we have significant differences or significant enough differences,
but we don't have nitty-gritty detail data, we only have fairly coarse
numbers about radon -- or radiation. So just not including the lung
cancer dose, just looking at the radiation -- external radiation
numbers -- this characterization that of course Colorado is lower and
the Southeast of the U.S. is higher in terms of all cancers, and doing a
number of socioeconomic confounding factors assessments, this first cut
at the data was a negative.
Well, that report was issued by Argonne to AEC in '73, and
that project was killed by Regulatory Research or the equivalent of
Regulatory Research in the AEC at the time. And Norm Frigario
eventually got that "published" by going to an IAEA conference on
low-dose radiation, because he couldn't get it published otherwise, and
it came out as a proceedings paper. So it was a brief kind of form.
And that was referred to in BEIR III, and dismissed in two paragraphs.
It was brought up as an UNSCAER 1977 document that was suppressed at
UNSCAER by the UNSCAER process that said well, we really don't know if
this is serious. But nobody went back and looked at the fundamental
analysis that was done on the Argonne study, they all just said well, we
got this one little paper in a proceedings and that's what we're going
to build our decision on. And before Norm died in '78, '79, he was
completely convinced that the characterization and the inability to get
the document published was simply a result of the commitment to LNT.
At this meeting in '96, that meeting of the subcommittee in
'96, Charlie Willis, who recently died here at the offices as I
understand actually being here overnight made a statement --
MR. HALUS: You have five more minutes.
MR. MUCKERHEIDE: Made a statement that said I came to
hormesis fairly late. In 1958 I was at Oak Ridge -- or he didn't say
Oak Ridge -- I was at the lab, and they had potassium without
potassium-40, and they were doing cell studies. And the cells looked
good but they didn't function. And it was the LNT -- and he made the
additional statement -- it was the LNT that kept that work from being
published. Now we know that the potassium-40 was removed from potassium
through the calutrons at Oak Ridge to do biology experiments through the
fifties. There was a 1962 dated bottle of the stuff that was used at
Argonne in 1982. And that material was recovered from animals, in fact
it was contaminated because it had been recovered from animals because
it was so valuable, and Argonne actually got another kilogram or
something of it made up, about $75,000 sometime around '80 or '82, and
yet you can't find any of the published results of that in the
literature.
And reports of people who were around the biology community
at the time said oh, yes, we did mice experiments with that, and when
the material was there, we had seen the detrimental effects on animals.
But that work couldn't get published. In fact, you can't find it. You
do a search in the literature, you can't find anything about biology
experiments. And you look at this in the context of what's going on
today and realize that for 40 years this process of basically denying
that the data exists is part of our legacy.
It became important in the fifties partly because it was the
argument against allowing the military to have control of the bomb and
some of the argument against above-ground tests in order to pursue the
issue of public fear of fallout, and some of it was public fear enough
to work against the post-Korean War period of the Atomic Energy
Commission and the Army basically trying to say hey, with tactical
nuclear weapons we can get into the battlefield, and there was some
concern that this thing would get back under the umbrella of the
military, especially after a lot of the successful experiences with
putting the soldiers in the field with weapons. So part of the campaign
was to create public fear about fallout, part of the official government
campaign of people I know who were involved in the time, Robley Evans
said he was involved at the time. One of the great mistakes we ever
made.
But now we're stuck with this, and it's, as I said
yesterday, whether you think of it in terms of the biology of the LNT
and its fraud, or the actual consideration of how much radioactivity
you're putting into the environment and whether or not it has an effect,
you can't justify spending the hundreds of billions of dollars we're
justifying other than to say the public is being misled.
And the one last statement I intend to make just on this
point is I thought Greta Dicus' comments were quite salient about this
significance about what we have to do about protection and why it ought
to be cost-effective, but there's an element that keeps coming in in her
remarks and subsequently that says well, it's the public demands it.
I'm here to tell you as I kind of said yesterday that the
public only demands it because they've been made afraid by the kind of
promulgation of a misrepresentation of the nature of radiation health
effects that this agency as well as EPA and DOE and others are directly
accountable for because they promulgate this stuff, and it's the
promulgation of an NCRP report in an unexamined way that leads us
directly to the point that we're at.
There is a lot more on the presentations of others that I
would address. I don't know how you are going to run the meeting
itself.
DR. WYMER: Well, we'll give other people a chance next.
MR. MUCKERHEIDE: I appreciate that.
DR. HORNBERGER: Could I ask just one question?
DR. WYMER: Sure.
DR. HORNBERGER: Jim -- I'll try to phrase this carefully.
In your view, if we had a completely neutral, unbiased group of
scientists look at all the data, would they inevitably come to the
conclusion that there is a threshold for an effect?
MR. MUCKERHEIDE: It's inevitable.
DR. HORNBERGER: And do you have any idea as where that
threshold might be in a regulatory sense?
MR. MUCKERHEIDE: Ten to 20 rem.
DR. WYMER: Thank you.
DR. GARRICK: Can we have some more questions?
DR. WYMER: Go ahead.
DR. YANIV: I would like to make just a brief comment to
bring to the attention of the committee a fact that the speaker
addressed NRPB, British standard of nuclear workers. Just two weeks ago
an expansion of this standard has been published with a much longer
follow-up and greater statistical strength.
Now I have not read this standard. All I know about it is
what I read in the latest issue of Nucleonics reported on this study.
I want to make an additional personal comment. The speaker
indicated that the threshold might be within about 20 rads of, say,
effective dose equivalent. Now this is a level coming up -- about from
natural background and medical procedure over lifetime, and let's just
assume that he is perfectly correct and that there is no linearity above
natural background, et cetera.
Now just imagine the regulatory scheme under those
circumstances. First of all, we won't be able to discount natural
background or medical irradiation because the cell doesn't care, it
doesn't know what it comes from, manmade or non-manmade.
Secondly -- so once we reach the threshold from whatever
source it might be, every milli or microrem is not equal to another
microrem and on top of that we do not avoid the linear scheme. I don't
think I have to continue to imagine the nightmare, the almost total
impossibility to do anything.
Basically, I would just say be careful what you wish for,
you might get it.
[Laughter.]
MR. MUCKERHEIDE: Well, I find it --
DR. YANIV: I will underline this is my personal opinion.
It is not anyone else's position.
MR. MUCKERHEIDE: It strikes me -- two things. Number one,
we have many toxic materials that we put in our vitamin pills that we
are able to manage quite well. The idea that we become into a nightmare
because we give up a straight line doesn't seem to me valid.
On the other hand, if you want to have a straight line, have
a straight line, but the issue is not to cook the science to help you
prove it and not to pretend that it is a scientifically based straight
line. Make it a policy-based straight line but don't bias the science
in order to justify it.
DR. YANIV: The question is who is cooking the science.
MR. MUCKERHEIDE: NCRP.
DR. YANIV: That is your opinion.
MR. ROCKWELL: No, that's a fact.
MR. MUCKERHEIDE: That's a fact.
MR. HALUS: If we can, there are other people I think that
want to have comments and presentations.
We have noted a disagreement on that, but let's move the
process forward, please.
DR. POWERS: I wonder if I could ask the speaker a question.
I think you have made some sort of a case that Dr. Upton has
acknowledged that maybe you didn't do a real good job in taking into
account some fraction of the data, and has made a commitment to do
something better.
Do you think that is going to change the outcome of the
report, which to my mind basically says there is a lot of data out
there. It doesn't yet have a consistent interpretation. We need to do
more research.
MR. MUCKERHEIDE: Do I think it will change it? No. The
data has never changed the reports in the past.
DR. POWERS: No, no, I'm -- I will concede a certain
disinterest on the part of the authors of this and say that having
examined the studies very carefully, would it change the conclusion of
the report?
MR. MUCKERHEIDE: Oh, yes. Oh, yes.
DR. POWERS: You think that these studies that were
neglected are so persuasive that even in the face of the stringent
statistical justifications that you have to have that they would lead
to -- there would be no need for any additional research, it would just
become obvious?
MR. MUCKERHEIDE: It would become obvious.
You look at it in one sense and this isn't the only way to
approach it, but in Japan in the early '80s up to about '85, '86, '87
they did a series of experiments with mice that if we look at what we
are doing today in molecular biology and by the time you get two
experiments people are ready to do clinical trials -- well, they did a
whole series of experiments and showed the stimulatory effects of
radiation at 10 to 15 r that was enough to start clinical trials and the
stimulatory effects of radiation in mice was dramatic.
They in 1986-87 were treating cancer with stimulatory
effects. They got into the same bind that the medical establishment
here has gotten into, because they couldn't get public funding for it
because, as one of the Japanese research managers said, ICRP was against
it and we couldn't get government money to support it so only a little
private money was available, but they started a clinical trial on
non-Hodgkins lymphoma anyway and found a dramatic improvement in the
success rate of treating non-Hodgkins lymphoma patients, even though the
only point at which they got to treat the patients was at the point
where they were pretty much beyond hope in terms of normal procedures,
and if you are going to try to stimulate the immune system ideally you
would do it a little earlier but out of that population of patients they
saved a number of patients over the five year survival rate and now in
the last year or so the 10 year survival rate.
To end up, here is Ted Quinn. Welcome, Ted -- and so if you
are in a mode where people are actually treating cancer successfully by
stimulating immune function then you have got that kind of underlying
science, but the issue is whether or not that science is acknowledged
and recognized when it comes to the subject of radiation protection, so
part of the disconnect here is that a lot of the biological sciences and
a lot of the interest in some of this information is not considered in
this process.
A similar situation of not being able to get at the data
exists in the Cobalt-60 contaminated buildings in Taiwan.
DR. POWERS: Well, I guess what I am saying is that you have
a lot of point studies. Other people have a lot of point studies.
There are viewgraph after viewgraph after viewgraph of point studies.
There still isn't a model that connects all these results that says ah,
yes, I can explain why this guy got this and this other guy got this
other thing.
MR. MUCKERHEIDE: I don't agree.
DR. POWERS: In that kind of an environment, people will say
gee, we need more research. I mean it is not the most novel outcome of
the study -- and I don't see how additional point models -- point
studies change that conclusion.
MR. MUCKERHEIDE: But you swing from the fact that I make
one example and treat it as though it is just a point. The fact is
there is a whole spectrum of studies and part of why we ended up putting
some of this documentation together, even though it kind of became just
contributions from a number of people, is that there is a wealth of
data.
In fact, in 1980 the first book on hormesis had 1269
references. It has been going on since the turn-of-the-century. I mean
Calabrese referred yesterday to the debate at the early part of the
century was whether or not it is a direct stimulation or whether it is a
damage response.
I mean this isn't new information. There's literally a
world of information that just is not considered.
DR. POWERS: But what I don't see is one of these plots that
has dose across this thing -- the horizontal axis -- and something on
the vertical axis with a curve coming in and then some sort of a
threshold mark on it and I have got lots and lots of point studies. I
just don't have a model that puts everything together.
MR. MUCKERHEIDE: Now, wait a minute. We are asking you to
do that. The only reason it doesn't exist --
DR. POWERS: You're not asking me, trust me. I am the wrong
person to make that plot.
MR. MUCKERHEIDE: I will ask the ACRS or the NRC or however
you want to look at it, but those of us who have commented on this since
the '70s have said the only reason that doesn't exist is because we can
spend $100 million to do a Hanford health study, $100 million on Hanford
and we can't spend money doing an assessment of the real data.
We can clean up Hanford for billions but we don't have that
job. That job is with the NCRP.
DR. GARRICK: Let me ask a question in connection with that.
You make the point of the dangers of doing research and
analysis from the point of view of a single cell and chromosome effects
without biological interaction. You were here yesterday when we heard
about the DOE research program.
What is your view about that program in relation to that
issue, in the relation to tying the phenomena at the single cell and
chromosome level with the biological systems?
MR. MUCKERHEIDE: The world of doing that research is very
important. It needs to be done.
The idea that somehow it is a de novo program I think is
false. There is a lot of data. There's the data that hasn't been
considered -- in fact, we don't even have computerized Russell's data,
spending $100 million over however many years in the early '50s to the
'90s, doing the mega-mouse studies at Oak Ridge. That data hasn't been
computerized and for about a half a million dollars it can be
computerized and there is an enormous amount of data there that is worth
recovering, and yet we always seem to treat this as though, hey, there's
new work to do, and in fact there isn't even really a substantial
pursuing of the issue that Russell's data was cooked in 1951 and that
that was stated -- in fact, what was interesting yesterday, one of the
points, was well, you know, we are concerned about the genetic effects
not of genetic effects so much as genetic related diseases.
Well, what is not really said there is that when it was
identified that Russell's data in 1951 that talked about a doubling dose
of 100 r was not including the cluster of mutations on exposed
population it became clear that the actual genetic damage had a doubling
dose of between 500 and 600 r, which is virtually a lethal dose, and so
that the whole idea that there could have been genetic effects went out
the window and so since that came up and those records were sealed in
1995, by the way, and since that came up the whole ICRP process has
shifted away from, you know, we don't have genetic effects but we are
concerned about genetic diseases -- and we have never identified a
genetic disease associated with radiation, but now that is where all
their genetics research money is going because we no longer have a
genetics problem.
But nobody has pointed out that it is because somebody, you
know, opened up the files and said, hey, you know, the data stinks.
DR. GARRICK: Let me ask another question, a follow-up about
research institutions.
You have also sort of made the point that there seems to be
an institutional commitment to the LNT by those bodies that are normally
entrusted with being the experts on radiation effects, such as the NCRP.
Maybe you include in that the NRC and maybe you include in that the
National Academy of Engineering -- because of the BEIR reports --
MR. MUCKERHEIDE: No -- actually the National Research
Council.
DR. GARRICK: National Research Council. What is your view,
and this question was presented yesterday, of creation of bodies or
institutions where you think that there would be a high likelihood that
the total database of merit would get reasonable consideration?
MR. MUCKERHEIDE: I don't have a conclusion. My one view
has been that we have an NCRP and an ICRP and they have tended to have a
focus on radiation protection and they are funded by the radiation
protection agencies and as a result we really don't have a full
consideration of biology, medicine and health sciences, physiology, et
cetera, that a lot of the literature that exists is in biological
sources that are not generally considered to be part of the radiation
protection establishment.
One of the comments, for example, well, some of these
sources are, you know, publications that are remote. And I look at, for
example, last year there was a publication in "Gerontology," in May of
'98, in France they took 300 mice controls, all in one room, 300 mice
with thorium under the cages, 7 mr per year, 300 mice -- 14r per year --
14r per year. The two exposed populations lived statistically
significantly longer than the control population, which is what we have
always seen when you have whole animal exposures.
But that data, I didn't even really pick up on it, but that
data certainly doesn't get to the radiation protection establishment.
But there are dozens, hundreds of studies. I mean this is where the
literature exists that is almost excluded. If it is not part of the
establishment science mainstream, then they tend to ignore it.
And it is easy for anybody from that side of the aisle --
and one of Don Luckey's problems, for example, biochemistry, head of the
department in a school of medicine, concerned about nutrition, concerned
about antibiotics, developed the understanding of the stimulatory effect
of antibiotics in chickens and small animals, and it is used in
agriculture. He established the principle of insecticide hormesis
because if you -- and we all know that you have got to take your full
course of antibiotics because otherwise germs get stronger. I mean all
of this is part of the same biological mechanism. But when he published
it on radiation, even though he had already done it on heavy metals in
toxicology, well, wait a minute, he is not a part of the radiation
business, so he is over there. And when he tried to get funding, just
like the guys in medicine who tried to get funding at Johns Hopkins or
the University of California at San Francisco, there is no funding. If
it is radiation, you have to go over there.
And Professor Kondo in Japan basically concluded only in
China is public health controlling studies of radiation effects. All
the other countries of the world, essentially, treat radiation separate
from the public health establishment, and so we value these things
differently.
So my argument conclusion is you need to move it into an
arena where the public health establishment, that doesn't have a vested
interest in radiation and radiation biology, can apply the normal
standards that they apply to whether or not there are effects and what
those effects are.
MR. HALUS: We have had a good discussion on this particular
topic. I believe there are other people who would also like to make
comments. Should we provide them an opportunity to do that, or are
there further questions that we need to ask at this time?
DR. FAIRHURST: I would just like one point of
clarification.
MR. HALUS: Please.
DR. FAIRHURST: I think -- let's say I have got your message
anyway. I wasn't here unfortunately, but apparently Dr. Land yesterday
gave a statistical assessment and what I heard was sort of the
statistical impossibility of extrapolating very low doses with obviously
concurrent very, very large populations. And then I heard somebody say,
well, you expect you will get a result supporting LNT, more or less, if
you use one-sided P values. Is this your position? I mean the position
that if you included the data that you have and had a totally
independent statistical assessment of that, you would see a threshold?
Is that what I am hearing?
MR. MUCKERHEIDE: Yes, I think that is correct.
MR. HALUS: Are there any further questions from the
committee? Is there another presenter that would like to make comments?
MR. ROCKWELL: Could I point out that Ted Quinn, the
President of the American Nuclear Society, did make it. I don't know
when his plane has got to leave, but if he could talk now, I think that
would be appreciated.
MR. QUINN: I would very much like to speak.
DR. GARRICK: Okay. Please. Please take the time now, Ted,
to go ahead and address -- if you would, step to the front and put on a
microphone.
MR. QUINN: Good morning, Mr. Chairman. Good morning,
panel. I am pleased to come before you for just a few minutes to
represent the American Nuclear Society. I have a number of messages
from the American Nuclear Society, and then I have a couple from myself.
The first is I thank you for a couple of minutes to have the
chance to come before you. I would like to recognize that I believe
today you have a very distinguished panel sitting at the table, with the
experience and credentials that can address this position.
The position of the American Nuclear Society is this is a
very serious issue, and I am proud that the ACNW has taken it on the
table to address it. It affects the future of our nation, it affects
the future of how we perform everything in nuclear science and
technology, and I believe you at the table, and with the input from
these experts that have provided it, are well qualified to address it.
The ANS is developing a public policy statement on the issue
of the effects of low level radiation. We are not ready to release it
yet, we are still in the works of developing the policy, but I think it
has elements in that have a short-term and a long-term nature to it.
The long-term nature addresses the importance of molecular
studies in science, as has been proposed by the DOE, and is working
through. And I believe those studies have great potential in the
long-term to address the issues that are so critical to us -- whether
there is a threshold, what is the process of cell reconstruction to
support the resistance from toxicity, resistance from radiation,
resistance from any other cell damage mechanisms? And I am very pleased
with that long-term progress and the fact that DOE is funding. We
certainly support continued DOE funding to make this work.
In the short run, I think this group, and I think our nation
has a responsibility to develop limits that are fair and equitable.
Now, I would like to step out and say what is my own
personal opinion. My own personal opinion is that the limits of 100
millirem are fair. I believe the statement of the Health Physics
Society, and I support it myself, is very fair and equitable. And that
is all I am prepared to say, Mr. Chairman.
DR. GARRICK: Thank you.
MR. HALUS: Do we have any questions from the committee?
DR. GARRICK: Ted, when do you expect the policy statement
to be finished?
MR. QUINN: I would say within the next three weeks.
DR. GARRICK: Is there anything you can say about? Pardon?
DR. FAIRHURST: I was just surprised that it would be
available so quickly.
MR. QUINN: We have been working on it for over a year, and
it is such an important subject, and somewhat controversial, that it
takes that long for us. And I apologize that we didn't have it to
present to you today.
DR. GARRICK: Yes.
MR. QUINN: What does it say? The thrust of it, again, it
addresses the importance of molecular science. As we go down the road,
it is critical to us that the human genome and other issues that are
doing so great in the technology of the future have the potential to go
in and address a threshold level in a scientific approach for molecular
science. That doesn't in a way denigrate or take away from some of the
other studies that are occurring, have occurred in the past, to provide
you with data from a scientific approach that can give an earlier
answer. But I believe in the long run, those studies are critical.
DR. POWERS: How did you arrive at 100 millirem was fair and
equitable? It just seemed like a good idea or --
MR. QUINN: I believe the current -- and this is, again,
what I believe and not what is a position of the American Nuclear
Society.
DR. POWERS: I understand. How did you come up, arrive at
100, not 200, not 50?
MR. QUINN: I am a power plant engineer, and I spend all my
time and days in the power plants. I am not a molecular scientist or a
health physicist. I would say my belief is based on the people that
work for me, or out there in the field that have stated -- or the
position of the Health Physics Society and others that have stated that
experts believe this is a fair and equitable limit. I can't tell you
myself, based on any personal experience, other than that.
DR. POWERS: You are in the same position I am.
MR. QUINN: Okay, sir.
DR. POWERS: Have to believe the experts.
MR. QUINN: Yes, sir.
DR. POWERS: But the experts have been called into question
here.
MR. QUINN: Okay. Well, I will reinforce the importance of
this particular group. It is an enormously serious question, and I am
very proud that your group is taking a straightforward approach and
looking at it. It is critical to our future.
MR. HALUS: Other questions from the committee?
DR. WYMER: We do want to thank you for making the effort to
get here.
MR. QUINN: Yes, sir.
DR. WYMER: Through a difficult traffic situation and
probably other problems.
MR. QUINN: It is, but the importance is that you are
looking at it, not me. The importance is that you are doing this, and
there are 250,000 people or more out there in the industry that depend
on your deliberations. So I look very much forward to the results of
your deliberations and I hope that all the scientists that you need to
help support this provide input to you in an appropriate manner.
MR. HALUS: Kim and Otto, do either of you have questions?
DR. RAABE: I have a question, Ted. The Health Physics
Society came out a couple of years ago with the position statement,
"Radiation Risk in Perspective." I am sure you are familiar with it.
MR. QUINN: yes.
DR. RAABE: Basically saying that there is no basis for
quantifying risk below an exposure of 5 rem or a lifetime exposure of 10
rem, but that we don't have any mechanism for quantifying it.
MR. QUINN: Okay.
DR. RAABE: What is the position of the American Nuclear
Society with respect to this position statement? Has the Society
discussed it in any way, --
MR. QUINN: Yes.
DR. RAABE: -- or do you have something to say about it?
MR. QUINN: Okay. It provides great input to the
development of our public policy statement on the effects of low level
radiation, we refer to it in there. The issue is we haven't signed it
yet today. So when you ask me what is the position, it is in advance of
my ability to say, Dr. Raabe, and the committee, that this is the
position of the American Nuclear Society. I spoke to my own experience
and not --
DR. RAABE: I guess what I am asking, do you see anything on
the horizon that would suggest that the American Nuclear Society would
contradict this or go with this?
MR. QUINN: No, absolutely not. No.
DR. POWERS: What is the position statement supposed to
accomplish?
MR. QUINN: Good question. You are asking good questions.
The issue of the position statement is that today, in the scientific
community, there is a tremendous amount of discourse in addressing this
particular issue. And I suppose maybe I could personally say the data
of that discourse, is I have had experts within the American Nuclear
Society working overnight, many nights to address the development of a
public policy statement in this issue, and some even present have spent
that. And the issue becomes it is significant, it requires, on the
behalf of scientific societies, a scientific approach.
If I was a representative of a trade association or -- I
mean I would take a different position relative. But we believe that
the scientific community can provide answers, and that there's two parts
to it. From the Wingspread Conference results, I am sure you are all
much more familiar with that than I am, there are two responsibilities
in our country we saw, that scientists that support this committee and
others come up with a scientific solution, and that the public policy
arena address the issue of setting up appropriate standards, and that
the public is made aware of those appropriate standards. All of those
issues are addressed in our public policy statement, sir.
MR. HALUS: Any further questions?
[No response.]
MR. HALUS: Thank you for your comments.
MR. QUINN: I would like to thank you again, Mr. Chairman,
and the committee for this time.
DR. GARRICK: Thank you.
MR. MUCKERHEIDE: Can I just make a comments about Ted's --
and stay there, Ted, so you can adjust this if I misspeak at all.
Having worked from the perspective of the Chairman of the Low Level
Radiation Health Effects Subcommittee at the ANS, my sense of where we
were driving over the last four or five years is that we are not -- we,
the ANS, speaking now, are not the experts, and signing on to the Health
Physics Society statement was not something that the ANS, through its
own Society, its own wisdom, if you will, as the engineering and
technology people, could or should really do.
Our issue is the debate is strenuous, it tends to not get
recognized very much, and it must be addressed by our institutions. And
I think, you know, reading into all of that, you have got to accept
that, in one sense, the ANS can't make a scientific decision on this
because it is really up to the Health Physics Society, the Radiation
Research Society and others where that debate goes on. On the other
hand, the emphasis we have had is we can't let the institutions continue
to set it aside it or ignore it. We have to urge that it be undertaken
in a serious scientific vein and not just as a matter of policy.
MR. HALUS: Thank you for your comment. Are there other
presentations that people would like to make from the floor? I guess we
have another one coming up now.
DR. POLLYCOVE: Well, again I appreciate the opportunity to
make essentially a couple of comments about the future and what should
be done.
First I would like to address the question of the molecular
biology and the models and so forth. I think that this is very
important because I believe that much of the resistance to departing
from LNT is stated very, very explicitly in the NCRP Report 121. They
have a biophysical presumption. They know that the damage done to DNA
is proportional to the radiation it receives, whether it's low LET or
high LET. They know that that damage isn't all repaired, and therefore
proceed to the conclusion that there must be an incremental risk for all
amounts of radiation.
Again, they state it in a very succinct and truthful manner,
and I don't disagree with any of the statements that I made so far.
That's all true. And Ted read this yesterday. So that any of these
effects as due to radiation of cancer, suppressor genes and oncogenes
being expressed and so forth, any of these effects could result from the
passage of a single charged particle causing damage to DNA, and we know
that damage is proportional, that could be expressed as a mutation or
small deletion.
It's the result of this type of reasoning that a linear
nonthreshold response relationship cannot be excluded. When you have
that firmly in the back of your mind, you're going to view all evidence
that supports this view as being scientifically correct and all evidence
that contradicts this as being some hidden flaw in it, there's something
wrong, because this is -- how can this be right and how can that be
right at the same time?
Now, it is this presumption -- and I use the word
"presumption" correctly -- it is this presumption that as a result of
this type of reasoning, that a linear nonthreshold dose-response
relationship cannot be excluded, it is this presumption based on
biophysical concepts -- and again, it's absolutely true -- it's based on
biophysical concepts, not biological concepts, not on an intact organism
responding with homeostatic principles. This is -- I could not -- this
is absolutely correct. It is this presumption based on biophysical
concepts which provides a basis for the use of collective dose in
radiation protection activities.
Now how can you justify any more strongly the necessity for
molecular biological models based on biology to explore this and find
out indeed if linear damage to DNA is translated into a linear risk to
the organism. This is exactly this question that is so valuable to the
DOE effort now.
Now that doesn't mean that one should then exclude
epidemiologic evidence that contradicts LNT. There's been a great
chorus of support. We don't want any more of epidemiologic studies like
Cohen. We don't know what's wrong with it, but it must be wrong. We
don't know what's wrong with the nuclear shipyard worker, but there must
be some mismatch in the controls, et cetera, et cetera, et cetera.
Well, I think that if a model, a biological model that can
explain how at the same time you can have damage that's proportional to
radiation, and you see, even if you repair the damage in a constant way,
and that's admitted, let's say 99 percent of the damage is repaired or
10 to the minus 6 is all that's left over, only one part in a million
remains, still this concept is absolutely correct. If you have a
constant repair of the damage, then LNT follows as night the day.
So we have to go to the molecular biology, and it's for this
reason that I began about a year and a half ago to work on a biological
model. And it was for this reason that we pulled together international
experts in a meeting in Berkeley to which Marv Frazier referred in June
of last year to discuss this whole topic, including endogenous damage.
There's no endogenous damage, and it's not affected in any way except in
a constant manner by the -- still it's LNT. So the endogenous damage
has to be taken into account, and these adaptive responses have to be
taken into account, and show the great high probability that these
mechanisms of prevention, repair, and removal operate on the endogenous
damage as well as the radiation damage. And from an evolutionary
standpoint this makes sense.
At any rate, so on this basis that the model was developed
that Marv Frazier felt was if all the experts can agree, and these
include experts on radiation damage, if all the experts on damage and
repair and so forth can agree on the model, then this furnishes a basis
for targeted research to see if some of the assumptions in the model
based on what we know now indeed are valid or whether they need to be
modified and so forth. So this is really why I think this molecular
biological research is so important, because we have to see whether this
biophysical presumption actually materializes as a correct biological
function.
Okay. Now there are many points in the NRC report that I
think demonstrate -- how shall I put it? -- the lack of impartial
treatment of both sides of the issue. And to focus on one only, with
the time that's available, I would like to just focus on Bernie Cohen's
work, because Evan Douple referred to that that the BEIR VI committee
gave it great attention, spent a great deal of time, in fact there was
even a BEIR VI workshop that we had for two days in preparation for
dealing with Bernie's data. So it did get a great deal of attention,
and was dealt with specifically in the BEIR VI report. It was also
dealt with specifically in the NCRP report which came out about a year
later after the BEIR VI report.
Now from the -- and I'll distribute this letter -- from the
Central Laboratory for Radiologic Protection, the director, Dr. Stavomir
Sterlinsky, wrote this letter to Dr. Meinhold, and he thinks that this
report is very important and certainly deserves an in-depth reviewing.
However, we received it relatively late and time limits restrict us to
only a few comments.
And I will only excerpt the comments that he makes, and then
show the data which was shown in the BEIR VI report which Evan Douple
put on the screen yesterday and contrast that data which was shown as a
justification for discarding Bernie Cohen's data with Bernie Cohen's own
data in his own report, which they refer to. All right.
Now, general comments. Papers quoting as supporting LNT
often contain data to the contrary, and evidence against LNT is often
downplayed. Ecological studies and epidemiology cannot be regarded as
trustworthy and should not be relied upon to study low-dose effects --
page 156. If they provide evidence against LNT, e.g., Cohen, 1995, yet
they are acceptable otherwise -- and specifically Dimidchik et al.,
1996, on page 180.
Page 154 to 156, ecological studies, this is an
exceptionally biased discussion -- now maybe biased is a harsh word,
Otto, but he uses it anyway --
[Laughter.]
In which the arguments of only one side are presented.
Cohen, 1995 study demonstrates LNT predictions of lung cancer mortality
due to residential radon -- and this is all Bernie claimed -- is not
confirmed by epidemiology. He says I'm not trying to prove hormesis or
anything else, I'm just saying that the predictions that are made by the
mine workers study and EPA are not confirmed when you actually go out in
the field and see what goes on.
Now, so, in this chapter five papers are cited in support of
statements that ecological studies such as performed by Cohen are
intrinsically biased. Cohen refuted most of these arguments in his
publications, none of which were even mentioned here. In other words,
they don't cite the Cohen responses to these criticisms.
A striking example of the biased treatment of this subject
is at the paper of Lubin, 1998, in which Cohen's work is criticized, is
cited here twice. However, the arguments from Cohen's reply in the same
issue of Health Physics, pages 18 to 23, and information that the
so-called Lubin's effect contributes very little to the huge discrepancy
between Cohen's data and LNT predictions, and offers no plausible
explanation of this discrepancy, are not presented.
A similar biased treatment of the available information is
continued on page 197, lines 1, 2, 3, 4, 15, 17, 18.
On page 158 -- sorry, that has to do with the atom bombs in
Japan. Let's continue with the Cohen. Here we are.
MR. MUCKERHEIDE: Page 197.
DR. POLLYCOVE: On page 189 again this has to do with lung
cancer and cigarettes and downplaying. All right, here we go. Page
193-197. This is a continuation of an attack on Cohen. Study
demonstrating that residential radon cannot practically be a causal
factor for any lung cancers in the United States. In this attempt to
disqualify the methodically meticulous work of Cohen four papers are
cited here. Cohen responded to this criticism, refuting most of the
arguments against his work, and he cites the Cohen and Colditz, '94,
Health Physics '64-'65, your reference Cohen '95, Cohen '97, Cohen '98,
Health Physics 7518, Cohen, ibid, page 23, Cohen '97, Health Physics --
none of these Cohen papers are even mentioned. A statement on page 197,
line 28, the results of Cohen's study cannot be relied upon should
perhaps end with "because it does not support LNT."
[Laughter.]
This is another example of a biased approach to NCRP SE 16
report.
Now let's look at the slide that Evan Douple -- here we
are -- in the front, here we go, good -- showed yesterday.
MR. HALUS: We have about five minutes remaining.
DR. POLLYCOVE: Okay. This will be very quick.
I want to point out that the bars are shown on the cohort
studies. The cohort study shown -- the average in a solid line, the
mean of about 9 cohort studies, that solid line. You can see the points
and you can see the bars on it. And then below it we have this sort of
figment of the imagination, misplotted, the points should go through
those lines, so it looks steeper and more ridiculous than it really is,
and no bars, no bars at all.
Now -- oh, thank you.
So anyone looking at this would say well, you know, here's
solid data with statistics and here is a fantasy. Well, what actually
does this curve look like? You see how small the bars are. They're
very tight. These don't begin to approach no effect, let alone theory.
Now perhaps they were annoyed by the fact that the theory is shown in
the dotted line.
[Laughter.]
But there are no points up there. There are no bars up
there. So they said well, we'll do the same thing to Bernie. But
Bernie has very tight, very tight. It's very interesting to note that
from four picocuries per liter on how big the bars get. Of course, the
reason for that, there relatively few homes that have that high radon
concentration. And that explains exactly why EPA set this -- there's no
scientific basis for setting the remedial level at four picocuries per
liter. No, you set it where you're going to get the least public
resistance. No science.
DR. RAABE: Myron?
DR. POLLYCOVE: Yes.
DR. RAABE: Can I say something about this.
DR. POLLYCOVE: Sure.
DR. RAABE: While you have it up here?
Myron and I participated in the hearing for the NCRP
committee meeting, and we were both present when Bernie Cohen presented
this to the committee, and Jay Lubin got up and criticized it. And what
it really came down to, Jay Lubin, who is really the author of this BEIR
VI model, he gave a very, very strong condemnation of the whole
methodology from a mathematical basis. It appeared to be quite a
rigorous mathematical derivation, with lots of equations on the board.
That went through because this being an ecological study,
Bernie Cohen did not know the dose to anybody. All he knows is the
average concentration in homes in these counties, so no particular
person's exposure is known.
Okay, so this is what you call an ecological study for that
reason. Now what Lupin did, he convinced the committee from a
mathematical argument that if there were a presumed unknown cross-level
confounder, mathematically the slope of this line could be anything, and
the committee accepted that.
DR. POLLYCOVE: I know.
DR. RAABE: That's what it comes down to. You were there.
DR. POLLYCOVE: Yes, I was there.
DR. RAABE: It was a devastating presentation. He took 30
minutes to condemn this methodology --
DR. POLLYCOVE: But it was on a theoretical basis and
Cohen's response to that and show that even if that were true and the
smoking were completely inversely related to the radon concentration --
in other words, you had more radon, the less smoking -- it still
wouldn't bring it up to the horizontal.
DR. RAABE: The point I wanted to make though is that the
committee heard both sides and they made a decision to accept Lubin's
argument. Now I don't personally accept it but I don't see the
committee as having some sort of sinister type of reason for rejecting
it.
They accepted the Lubin argument and it was a very strong,
well-presented argument so when the committee sat down to go over it,
the way I look at it, they said, well, if Lubin is right, then Cohen's
slope is meaningless, because that's what Lubin said.
DR. POLLYCOVE: Then what is the point of not plotting
Bernie Cohen's curve correctly and dropping the bars and all of that?
That has nothing to do with theory. That has to do with scientific
integrity. That is my point.
It's not a linear model.
DR. HORNBERGER: Put that back up there. That's an
exponential model?
DR. POLLYCOVE: No --
DR. HORNBERGER: Plotted on semilog.
DR. POLLYCOVE: This is plotted on semilog, right.
DR. HORNBERGER: That's an exponential model.
DR. POLLYCOVE: Right, right.
DR. HORNBERGER: It's not linear -- it's not a linear no
threshold model.
DR. POLLYCOVE: No, that's right.
DR. HORNBERGER: Just a point of clarification when you have
that up there.
DR. POLLYCOVE: Oh, sure.
DR. HORNBERGER: I think I know the answer but --
DR. POLLYCOVE: Right.
DR. HORNBERGER: Are the indoor studies and the miner
studies -- I assume that they are also corrected for smoking?
DR. POLLYCOVE: Yes, presumably, although you see, the
smoking of the miners I don't know how that was objectively determined.
In fact, I don't even know how the exposure of the miners was
objectively determined.
Many of these miners were people who worked 16 hours shifts,
although they only considered 8-hour exposures every day they worked,
and some of them slept overnight in corners which had enormous stasis
and collection of radon, so that the dosimetry of the miners study was
far worse than the dosimetry on the counties where they actually
measured the residential, average residential radon exposure in the
homes and assumed they were in so many hours a day, and even the ones
where they did individual and the case control studies, there was no
telling exactly how many hours each member of the household spent in and
out of doors so that the exact dosimetry was very difficult, but it was
particularly loose in the miners.
DR. HORNBERGER: Yes, well, one of the reasons I asked -- as
you know, I am not an expert --
DR. POLLYCOVE: Right.
DR. HORNBERGER: -- but I served on a committee with
somebody who did some of these miner studies and I recall, I may be
recalling incorrectly, but I recall him telling me that it was a very,
very strong correlation with smoking, that basically --
DR. POLLYCOVE: Oh, yes.
DR. HORNBERGER: -- basically that miners who did not smoke
basically were not affected by the radon exposures.
DR. POLLYCOVE: That's right. In fact, that was the
response of the BEIR VI committee when they were asked, well have you
checked the radon in you home? The only one that responded -- everybody
stonewalled on it except Roger McClelland, and he said well, no, I
didn't check it but I don't smoke so it doesn't make any difference.
DR. WYMER: Do we have other questions about the
presentation?
DR. RAABE: Just one comment on this one. Those so-called
datapoints are not actually data. They are the result of a very
complicated, maximum likelihood logistic -- as Charles Land described to
us yesterday and those are the estimated means and the standard -- and
the 95 percent confidence range for those means.
The actual data, which I have here, is a scatter plot.
DR. POLLYCOVE: Right.
DR. RAABE: It's a scatter plot, okay? So this is generated
by a computer program with a log linear model and it is anchored at the
zero dose point. There is no zero dose point. That was created by the
computer.
DR. POLLYCOVE: Right.
DR. RAABE: Now if I would suggest that that zero dose point
which creates the relative risk of one was off by just 10 percent, you
can suddenly get a straight line across there that has no dose response
relationship at all, so there is a lot of things going on in this --
DR. POLLYCOVE: Right, and even these, every one crosses the
no effect line.
DR. RAABE: I have to make one more comment and that is I
did my doctoral research on radon in the '60s. I think I know something
about it. Now these case control studies, yes, they correct for smoking
because they match the case control so that they have smokers, but how
would the figure out the dose to radon over the lifetime of these
people?
Now I studied radon, you know, and I know a lot about it I
do not think I could estimate my personal lifetime radon dose. Now can
they get it by looking at somebody's home where they happen to live at a
certain time? It is a very difficult problem, to get these doses, so
there is a tremendous uncertainty in the doses and there is the
structure of the regression -- so there are real questions.
DR. POWERS: You were persuading me that the argument that
the slope of the line could be anything is essentially true. I don't
think that either study proves anything anyway.
DR. POLLYCOVE: Well, this study shows that the predictions
of EPA that if you live in a high radon residence that you have more
chance of having lung is incorrect, and that is all Bernie Cohen
claimed, that they -- with tremendous statistical power he showed that
people who live in homes with higher concentration of radon have less
risk of cancer when using the same correction for smoking that the BEIR
IV and the BEIR VI use and even if you assumed that there was an inverse
relationship you still couldn't get this line to be horizontal. That is
what he showed.
DR. WYMER: Kim, did you have a question you wanted to ask?
DR. KEARFOTT: No.
DR. POWERS: It strikes me it is of limited predictive
value -- that is, I would not reduce my rate of lung cancer by injecting
radon into my house. I have to inject in radon plus engage in all of
the other activities that might affect my --
DR. POLLYCOVE: Well, all the other activities you can think
of -- he has expanded this to 150 socio-economic factors and shown how
each of these will change the slope, and none of them got to zero, and
they flip-flopped around the average, and when you take 90 percent of
the population, these other factors will bend one way or another but
statistically the only way you can get this kind of effect, and as I
said this was not only seen by Bernie but seen by many others.
In fact, let me tell you how objective Bernie was. For the
first few years that he was looking into this, he believed that radon
produced cancer. He installed a ventilation unit in his home. He got
rid of the stuff out of his basement, but by the time the data piled up
into the
'90s he turned the switch off.
[Laughter.]
MR. HALUS: Chairman, I believe you had a question.
DR. GARRICK: Yes. Before Myron leaves, I want to ask him
one overarching question.
Given what we have heard the last two days, and assume for
the moment that you are the ACNW, what single recommendation do you
think would best reflect -- what single recommendation to the Commission
would best reflect what we have learned?
DR. POLLYCOVE: Well --
DR. GARRICK: If you want to make two, that's okay.
DR. POLLYCOVE: Well, first of all, I would say that we
learned that -- in my own personal opinion -- we have learned that there
are tremendous biases built in because of the focus on radiation damage
and the acknowledgement that for all practical purposes -- this is a
little slight change -- but for all practical purposes that radiation
damage of DNA indeed is proportional to the amount of radiation, period,
and because of this firm concept, as stated in their own NCRP
publication, they feel that it is illogical even though they don't have
any data, they say they have no data to support it and some data
contradicting it with high statistical power, it's all admitted in that
one summary, nevertheless that this has to be adhered to, and so
therefore this report demonstrates this bias.
They want to stay with what they understand, with what is
clear and logical, and what supports that they highlight and what does
not support it it must be flawed, and they tend to -- so it is not an
impartial, because there is this strong basis not being impartial.
Okay. So what I think is needed is, as was suggested
yesterday, is to have an entity, and perhaps the Surgeon-General is not
the best but on first blush it would seem that here's somebody that is
impartial, that can get a group of scientists that have not been
identified. In other words, even though these people are expert, they
should not be included because they have demonstrated repeatedly that
they are going to cling to this central viewpoint -- people that are
more biologically oriented, that have not been associated with the
radiological protection.
As pointed out, recently it came to my attention that in
Japan there's a study that has been going on for over six years. In the
first three years they gave tritiated water for a lifetime to mice and
showed indeed that there was a great increase in cancer as the dose went
up. Then after they did that study, they went to very low doses, by low
doses meaning about in the order of 100 mr per day, which is low dose.
That is what we get in a year these mice got in a day. They showed that
at these very low doses that cumulative, over a lifetime, these mice
showed marked decreases in cancer. For instance, all cancers were
reduced to 40 percent of the controls and with a P value of .0007.
Now that study was not cited in the NCRP report and yet
another study, another revision by Jeffrey Howe, the Canadian breath
fluoroscopy study, was cited even though it hasn't been published and it
was cited as being published in 1998 in the American Journal of
Epidemiology, and hasn't been published yet in 1998, so they reach every
shred of data that they feel can invalidate the Canadian breast
fluoroscopy study.
I am just saying that because of clinging to this point of
view that you need to get people who have not been familiar and active
in this and perhaps selected by somebody that is impartial and
scientific from the biologic community and not the radiation protection
community.
DR. GARRICK: So basically the recommendation would be
because of biases in the NRCP report we need another study?
DR. POLLYCOVE: Right, right.
DR. GARRICK: And it should be biologically based rather
than --
DR. POLLYCOVE: That's right.
DR. POWERS: I guess I am struggling with what that
accomplishes. You would have a bunch of studies over here, and I find
your arguments on the biophysical very persuasive -- if I have that
mindset then linear follows as night follows day -- and then on the
other hand I find persuasive also the arguments that say cells in petri
dish don't have the full amino and biological response and so the
biological thing could give you a different model and in fact I have
been fiddling around -- can I create a model that does something here?
Stay tuned.
DR. POLLYCOVE: Well, we hope it will be published this year
in either the National Academy of Science or Science so we will have
something out front.
DR. POWERS: But here is the problem I see is that now I've
got another study that says now things go not linear. Okay. Do I stop
there?
DR. POLLYCOVE: No.
DR. POWERS: I got to get in another study that doesn't have
the prejudice that's there. I have got more and more studies.
DR. POLLYCOVE: Well, it's not a prejudice. If you gave
tritiated water to mice in varying doses, and you just find out what
happens, and you find out that at the high -- they did the high dose
studies first and they found out that indeed the cancer increased
proportional to the dose and lifespan was shortened proportional to the
dose, and when they went to the lower dose tritiated water study for a
lifetime, they found that they lived longer and they had less cancer.
Now I don't see why that is prejudicial.
MR. HALUS: Okay -- do we have further questions from the
panel?
DR. POWERS: Well, I would still like to understand how
having this study helps. I mean it seems to me the far bigger help is
to have, yes, a model that doesn't have this biophysical basis on it --
DR. POLLYCOVE: I agree.
DR. POWERS: -- and say here are the experiments one can do
that would say yes or no.
DR. POLLYCOVE: Precisely. That is where I started.
DR. POWERS: I think that is a far more valuable
recommendation to you than yet another study with a different group of
people.
DR. POLLYCOVE: It's hard to understand, it is hard to
accept things that you don't understand. In fact, your understanding
contradicts those results. It is hard to accept that.
MR. HALUS: Are there other questions or comments?
DR. RAABE: Just one quick comment. I think the committee
is starting to get the feeling here that nobody really understands the
mechanisms by which radiation produces cancer. If they did, they would
get the Nobel Prize, so they're all guessing. We all know DNA is
involved but cells are involved, tissue, organ systems, cells talk to
each other. Nobody really knows all the pieces and so this is why there
is such a disagreement in the scientific community and if someone is
concentrating on the biophysical piece, then they will project that and
say well, this represents it.
Also, the things that are published are not all of equal
quality.
And I have looked at a lot of papers that supposedly show
things, maybe it is a mouse study -- I didn't look at this one, all
right -- but I go in there and look, as a researcher who has worked with
animals, and I know there are real serious problems in how you set up
your controls in these experiments. And I look at these studies, and I
have talked to people, and I say, my goodness, they could get any result
they wanted by misrepresenting the controls, you know.
And one laboratory actually took a bunch of mice that came
in and exposed the first batch to the radiation, and then they wanted
some controls, so they ordered another batch, and those were the
controls. That was actually reported at a national meeting. And they
found hormesis, believe it or not.
Now, I am not saying that represents all -- I am just saying
each study has to be looked at very carefully. And, also, when a
scientist looks at these studies and sees an observation that disagrees
with his, perhaps his model that he has, based on other work that he has
done, he also realizes that there are chance observations that occur in
studies that may agree or disagree, and the standard of acceptance is
always going to be higher for some unusual results, results you consider
to be unusual.
If I send up -- some of my papers, I have trouble getting
published because some of my results are unusual. But the standard is
higher in science. Scientists say, well, you got an unusual result, you
have got a bigger task to prove it. You have to do a lot more. And it
is not that you are biased or there is some conspiracy against it, it is
just that the bar gets higher if you come up with something that is
different and doesn't quite fit the model that everyone is working with.
MR. HALUS: Are there other questions for the speaker?
MR. MUCKERHEIDE: Can I just ask one question? Myron, you
pointed out the fact that radiation damage to DNA is linear.
DR. POLLYCOVE: Yes. Essentially linear.
MR. MUCKERHEIDE: You didn't mention the relationship to the
level of background, normal metabolism and whether or not linear would
necessarily result in health effects if you are in the large background.
Can you just give a little bit on that?
DR. POLLYCOVE: Well, I alluded to the fact that if you only
consider radiation damage and not the response of the organism to the
damage as Ed Calabrese dwelt on yesterday, then it follows inescapably
that if damage is translated one to one into life-shortening and cancer,
then it is inexplicable that low doses could have the opposite effect.
And it just turns out that when you take into account the adaptive -- I
am sorry, I am not addressing your question.
MR. MUCKERHEIDE: Right. I wanted to put that in the
context of normal oxidative metabolism breaks.
DR. POLLYCOVE: Okay. Well, yes. Well, I didn't want to go
into the model itself. It turns out that when you look at the amount of
damage that is caused by radiation at low doses, per day, continuous, to
the damage that occurs endogenously from the free radicals that are
caused by oxygen metabolism, it turns out there is an enormous
discrepancy, so that even when you take into account that there are 2
percent of the damage that is done by low LET radiation is -- performs
-- results in double-strand breaks, and that only one in 10 million --
we did a statistical analysis which the radiation damage gurus and these
experts agree with, that only one in 10 million of the random damage
done by free radicals produces a double-strand break.
There are so many that occur each day that it turns out,
surprise, that there are more double-strand breaks, far more
double-strand breaks per day from endogenous damage than there is from
the low level radiation damage, and not in the one in 25 years, and so
forth, and so on, which is just some wild guess, I don't know where that
came from.
But anyway, I think this is what -- but this is all part and
parcel of the model that we are working on, nearing a final draft, and I
really don't want to talk about that any more than ANS wanted to talk
about the policy, President Quinn wanted to speak about the policy of
ANS, until all of us authors, or seven of us, sign off on it and submit
it for publication. Once we get to that point, I am willing to talk
about it.
MR. HALUS: Thank you very much for your comments. Thank
you very much for your presentations. Let's go ahead and take a break
at this time, say, a 15 minute break.
DR. WYMER: Yes. And when we come back, then we will go
into a discussion of our report based on this meeting and the discussion
period is essentially over at this point.
MR. ROCKWELL: Can I just make a quick answer to John's very
important question about what should you recommend? One, I think that
it is important to point out that serious questions have been raised
about the basis for many of the conclusions in this NCRP, and those
should be responded to because the report is not -- should not be
considered accepted and valid until some of these very fundamental
questions that have been raised, time and time again, and ignored time
and time again, are responded to. That would be the first thing that I
think is important.
And then, second, whether or not the LNT as a model is
repudiated is less important, really, than facing the question of how
low down are we going to continue to insist that we are killing people.
The idea that we now say we are killing people at 100 millirem, at 10
millirem, at 1 millirem per year, we have got to face up to that
practical question, which is the real burden on us right now. And to
say we don't know and, therefore, we are going to assume that we kill
people, and actually have the Department of Energy send out a report
that says they are going to murder 23 people by shipping shielded casts
of rad waste around, as long as we are saying those things, I think we
are not in realm of science, and we are really just killing this
industry.
MR. HALUS: Okay. Thank you for the comments. We will take
a break at this time. And would you still like to start at half past or
25 till?
DR. WYMER: Twenty-five till.
MR. HALUS: Okay. We will start 25 till, and that concludes
the discussion from the floor. Thank you very much, everyone, for
participating.
[Recess.]
DR. GARRICK: Okay, I guess the meeting should come to
order. Ray, I think what we want to do now is have a discussion among
the committee members, the consultants, et cetera, on what we have heard
and what it means, and see if we can begin to flush out some of the
nuggets that might be the basis for us to make some recommendations to
the commission.
DR. WYMER: That's right. I think we have, both you and I
have independently suggested to our consultants that we really want them
to do all the work. So I guess we would like to hear, as a starting
point, what each of you, in turn, have to say about what might
constitute recommendations and input into a report.
DR. RAABE: Before we get into that, I wanted to make one
sort of observation about what we have heard over the last
day-and-a-half. To me, as a radiobiologist, there is a big gap and what
we have heard. And there is a big gap in what BEIR VII is trying to do,
and there is a big gap in what the NCRP report does, and that gap, I
think is crucial. That gap is inadequate treatment of the effects of
protracted radiation.
In fact, I could even justify recommending that we should
have a report where the committee is asked only to look at protracted
radiation instead of --
DR. WYMER: Protracted low level or just --
DR. RAABE: Protracted, it doesn't make much difference
whether it is low, you have to put the high level -- as a scientist, you
have to put the high level in with the low level to see what the shape
of the dose response curve looks like. But protracted radiation, for
example, -- it is really what we are talking about within the nuclear
waste issue, really, internally deposited radionuclides.
You heard in the BEIR VII presentation yesterday, they said,
no, we are not going to cover internally deposited radionuclides. So
that means they are going to emphasize the acute high dose rate, atomic
bomb survivor studies and other related medical data, and very little --
they won't touch on what probably is the most important issue.
Also, they work with a very simplistic model to take all
these analyses they do of acute high level radiation and try to predict
what is going to happen from protracted radiation, and the model can be
shown easily to be wrong, by looking at actual data on humans and
animals with protracted irradiation.
So I just see that as a gigantic gap, you know, we just
didn't get it. Some people touched on it a little bit, but only a
little bit. And the whole basis of protecting the public with regard to
radioactive waste is probably low doses of radiation protracted in time.
And if there is a significant difference in the shape of the dose
response curve, then we should know that.
Now, I actually have worked for about 20 years in analyzing
protracted radiation studies from internally deposited radionuclide,
looking at about 12 radionuclides, and both high LET and low LET, and I
can tell you that from my studies, I always found a very pronounced
effective threshold. Very pronounced.
Now, that is just, you know, that is my observation of data.
But I think the whole point is, if there is a true difference in
response, and there is an effective threshold associated with protracted
irradiation, we need to pull together the information about protracted
irradiation.
DR. WYMER: Okay.
DR. RAABE: The other one little point, just a technical
point that came up a couple of times, and I mentioned it at the very
beginning yesterday, and some people asked, well, what did I mean by
this? Linear no-threshold has two parts. It has the linear part and
the no-threshold part. Now, to some people, when you say there is a
threshold model, they think, oh, that means there must be some dose at
which the risk is zero. Well, we can prove there is no zero risk
because, you know, as Art said yesterday, there are some DNA changes
that aren't repaired.
When I talk about a threshold model, I call it an effective
threshold model, I just talk about the risk going down to very low
levels. And when I calculate a risk of 10 to the minus 20, at some low
does, for all practical purposes, I ignore that. It is probably the
chance the ceiling will fall in this building because some engineer
miscalculated some stress on some beam.
MS. THOMAS: Don't say that.
MR. LARSON: That's 10 to the minus 4.
[Laughter.]
DR. RAABE: So, you know, to some people, when you say
threshold, they say -- it clicks in their mind, zero, zero risk. Well,
I don't know if we can -- we can't find zero risk, and I am not sure we
need to.
DR. GARRICK: I like to call that the speed limit mentality.
DR. RAABE: And so the other thing -- and if you read -- I
read the whole NCRP report and this is a very important part of the
first several sections, that they come to the conclusion that since
there are DNA changes that are not repaired, that, obviously, you cannot
have a threshold.
Now, the linear part is interesting, too, because they also
say, therefore, the linear is the best model. Well, why linear, you
know? Curvilinear responses are very common in biological studies.
And, so, could it be curvilinear with no-threshold?
So those are all questions that just popped in my mind as
things were going on yesterday.
DR. KEARFOTT: I could give a summary of my impressions if
you want it.
MR. HALUS: That would be great.
DR. KEARFOTT: We have time. I just want to start out by
saying I am not a toxicologist, I am not an epidemiologist, I am not a
biologist, I am not in risk analysis, but I feel like a voyeur about to
become a target in an interdisciplinary scientific spitting match. I
shouldn't have said that publicly, but I am prepared to get wet, so my
comments are only from someone in a closely-allied area looking at what
I have heard in the last day.
I view there as being three problems associated with this
whole issue, credibility, certainty and creativity. Credibility, we
have a two-pronged problem. The first part of that problem is acceptance
by the public. The second part is acceptance by the scientific
community. Certainty, we need to know what is really possible to answer
and how well can we answer it. We need to be realistic about what we
can know, what is needed to change things, and the need to proceed in
the public interest needs to inform our interpretation of certainty.
The third issue, creativity, I am struck by a lack of new
approaches. The approaches appear to be the same old types of research,
although I was given some hope with the humane genome project. There
seems to also be some dissonance among the results that is based upon
disciplinary lines.
I would like to see somebody, and it is probably not NRC,
but someone with timeframes for action, to try to look at radical
advances, the Manhattan Project, broad and forward thinking individuals
who would be unrestrained and unfettered in looking at what are the
fields and technologies, et cetera, and DOE has started to do that, that
can inform this better. That is probably beyond what this particular
committee can do.
I want to make some brief comments about what I viewed as
each of the research areas and then make some recommendations to you
about that. First, is the epidemiology, and I am going to also lump in
there, and I will get wet doing this, both the human, animal
epidemiology, and the non-human animal research, which I realize is much
more controlled. It seems that that is where the human endpoints
reside.
The results of epidemiologists' studies will also help us
with workers in accidents, but may not be that helpful because of the
dose ranges that are practical in looking at public stuff, these two
types of research are very useful for testing low dose models. The work
on this data will help us, give us a better launch point or
extrapolation point, the lowest point at which we have data about
endpoints, and it will help us understand the confounding factors that
may be involved in the inductions of cancer and other effects. We might
need new studies along these lines, but we have to be very careful about
what type of studies are done.
I also get the sense, and I will address this with one of my
recommendations, is that there is not really a reanalysis of older data
and good quality control of datasets when trying to combine them to make
a result.
The cellular biological research is the second category of
research. I think these are important in giving us the models to go
below where the animal and non-human -- the human and non-human animal
research takes us. It will help us understand the possibility, the
validity, et cetera, of hormesis and is the basis of all our models.
We have to be very careful with the cellular research,
though, that we don't confuse damage and significant response.
I think with these areas of the human epidemiology, the
nonhuman animal research and cellular there are other issues that affect
those that are holding them back, for example, the way that we're
analyzing things. Secondly, different things like what dose quantity is
being used and is it appropriate for the type of study. And I have some
basic questions about that.
I also hear things like well, the absolute doses measured
will not really affect the results, they just shift the curve. Well, if
you have a nonlinear curve, having an error in your jumping-off point
will have a very serious effect on the results. For example, if you had
an exponential model, then where you're setting the doses and what
quantities you're using for doses are going to completely confound
things.
The third broad area is about regulatory research, how do
you regulate and perform operations in the presence of uncertainty? I
think the risk-informed approach is something that there's probably
research, it's not scientific, but policy-related research on regulatory
mechanisms. That might be something that NRC staff should be encouraged
to absolutely continue.
The fourth area would be in risk communication and how we do
things, and in fact it informs how we treat the results of the other
research, and that's both to the scientific community and to the
nonscientific community. How do we get acceptance, how do we put
through a change and get that accepted? And how do we get scientific
consensus among fields? Certainly risk communication and how to run
meetings and making sure there's open and how we do this is beyond my
expertise, but I identify that as an area of research.
The last area is something that struck me in all of this,
and this has to do with the synthetic methods of analysis by which we
integrate data from different disciplines in order to get a result. And
I'm going to speak to that a lot. I do not believe that we have
necessarily institutional bias by NCRP, NAS, or NRC. There is something
more subtle going on that's affecting the acceptance of this work, and I
will address that. Areas of this sort of synthetic methods analysis
include items like interdisciplinary peer review of what's happening and
are there -- what are the limits of science itself and to how we're
reviewing things. Secondly, how you link disciplines together to inform
policy. And the third thing which we actually were hearing a lot of
this veiled today, the third thing is how to analyze and build models
with data from different disciplines. So that's probably the area that
should receive the greatest effort at this point if you want to do a
fast result.
I have several recommendations that fall out of that
perspective. Some are -- they're on different levels. Some appear
trivial and some appear sort of more broad sweeping.
First of all, before hearing Otto's comments, I was struck
that not only were a lot of the data that were flashed before us very
quickly -- not only were the dose ranges not going anywhere close to
what we're interested in, subcentigray, and -- or wherever you want to
pick it -- that they were not the right type of data. These are all
external exposures, except for the radon base, and I'll privately
discuss my opinions on that with anyone who will give me ten minutes.
They are primarily external exposures. They exclude for the most part
not only sort of protracted or low-dose-rate things, so we have no low
dose, we have very little low dose rate protracted exposure information,
but we're also missing high LET data. And those are exactly the effects
and things of concern when we're talking about decommissioning,
decontamination, low levels in the environment. We're talking about
internally deposited radionuclides.
When you open that, there are things that aren't even being
looked at, like dose distributions within organs. I've done a bit of
work in nuclear medicine, internal dosimetry, and they found out that if
you take an organ and you divide it into the different cell types, in
vivo, that you assign dose quantities that relate to those cell types,
and you use dose distributions on that to recalculate things, you get a
much better correlation between dose and effect. And I think they're
just starting to do that in nuclear medicine and radionuclide-based
radiotherapies, which are right out at the front of the map in those two
disciplines. So there's a lack of internal data, which are the most
important, and if anything, you would serve the scientific enterprise by
supporting strongly, even though NRC may not do or fund this, but
supporting strongly research in that area.
Secondly, we need to continue the biological research
support, DOE's program, and allow high-risk innovative research. Along
that line, because of the policy implications of that research, it is
imperative that NRC be engaged, even as an observer, in the interagency
reviews of research in these areas.
The policy issues, as we heard, are quiet strong. The
industrial issues, as we heard from President Quinn of ANS, are quite
strong. So in research being conducted and things going on with NAS,
DOE, NASA, DOD, NCI, et cetera, in particular the new DOE program, NRC
should at the very least have active observers following what's going on
so that NRC can stay in touch with changes, advances, while they pursue
concurrently what they need to do in terms of other issues.
I'm just going to put in a plug for this, as we cannot
ignore the need for research aimed at cost reduction in measurements and
remediation activities despite trying to look at our limit, I think cost
reduction is something that will actually help the industry.
My last point is probably the most controversial, and it
sort of has two parts. I don't believe in a conspiracy theory, but in
hearing how BEIR and NCRP are working, and we've heard their consensus
process, I think these are very noble efforts to do a proper consensus
process, but you think about it, you have 16 experts on a BEIR report,
and there will be one person who actually is the person who is figuring
out how to tie together all the data and derive the result. This might
be a mathematician or statistician or someone. The same thing with
NCRP.
You have 60 council members. There are not very many of
these data-synthesizing people involved who are council members of the
NCRP. When the BEIR and NCRP reports go out to comment, they go out to
the stakeholders. They go out to the specialists in radiation
protection, they go out to the radiation biology specialists who may
favor, just by virtue of being scientists, they're going to favor
theories that support their own work. And it's not going to go out to
mathematicians, the statistical society, to the people who are scattered
across disciplines who are actually bringing together the work. So I
would favor something that said there needed to be independent research
in the synthesis of this data and analysis by which these models get
derived.
And I would further wildly speculate that there have only
been a handful of individuals involved historically with that in the
past. Which I then sort of as a slightly more wild recommendation would
say the following which actually supports (e), which is that we need to
have because of the historical mistrust by both the public and the
scientists, and this is a large undertaking I recognize, some
independent new group or groups that will start doing two things.
I mean, one thing, you could totally revise the NAS and the
NCRP process. That's one approach. The other is to try to find a new
group or groups that will do two things. No. 1, they will rereview and
attempt to synthesize the existing data, making sure there's peer review
of the experts who are doing the synthesis. These are people from math,
statistics, et cetera, who happen to have specialized in radiation. But
they're not getting peer review necessarily by people outside the
radiation field in the synthesis.
And, secondly, there might be something to be gained by
taking all the data that we have, doing quality assurance or quality
control in reanalyzing it. When you do that, you have to be very
careful you don't miss 75 percent of the data, and, secondly, that
there's an independent judgment, interdisciplinary independent judgment
of the quality of the research. No matter how nice your data bases are,
if you don't do that, you're not going to get results that are totally
credible.
So I think I've said more than I should have, and that
summarizes my impression of this meeting.
DR. GARRICK: Thank you.
Otto?
DR. RAABE: Okay, back to me.
Well, I don't have quite as elaborate a presentation
prepared, but I made the point about protracted radiation, which is
something that's very near to what I'm thinking about, and I wanted to
just point out a few things that we do know really well about protracted
irradiation.
For example, a lot of people in this century have been
exposed to radium-226, and this has been under study for a long time.
This book "Radium and Humans" written by Bob Rowland out of Argonne
Laboratory summarizes all the data, the effects data and the dosimetry
data, on some 2,000 people, 1,450 of them who were exposed to
radium-226, very high levels, mostly earlier in the century. Radium
was -- I think Marie Curie got the Nobel Prize for separating radium in
1905 from uranium, and after that it was used for all kinds of things,
medical potions, put in drinking water, and for luminous dials. And by
1909, just four years after she got the Nobel Prize, you could buy a
watch with a luminous dial or a clock with a luminous dial with radium.
And the workers who worked with that material got exposed at high
levels. But also chemists got exposed, and it was used in medicine.
Well, the studies of these people have gone on for at least
50 years. Robley Evans was a big investigator in this at MIT, and then
it was taken over by Argonne.
What do these data tell us about high LET irradiation of the
skeleton from radium? That's the question that we have human data.
Well, Robley Evans in 1972 went around the country and pointed out in
lectures he was giving, he was president-elect of the Health Physics
Society at the time, he went around and said hey, there's a practical
threshold. The reason I know this is because no person whose dose to
the skeleton was less than 1,000 rad, which is 20,000 rem after you
correct for the quality factor for alpha particle, developed bone cancer
or had any other effects that we could observe. That was 1972.
Okay. Now we have Rowland's report just a few years ago
summarizing the final data -- that it will get. There were a lot of
people still alive in their eighties and nineties in good health that
didn't get into the final report when the study ended.
What is Rowland's conclusion? No person whose dose to the
skeleton was less than 10 gray, 200 sievert, 20,000 rem, developed bone
cancer. We're talking about a gigantic dose. Is this a fluke, or is
this real? Okay. So you look at animal studies with radium. Well,
it's easy to show why this occurs with protracted exposure. It occurs
because when exposure is protraced over a lifetime, there isn't a linear
response, nothing happens for most of the person's lifetime, and there's
a long induction period until you actually have the bone cancers
develop.
As the dose rate goes down, which is the concentration of
radium in the skeleton, and you have to remember that when people were
exposed to radium they had it in their skeleton for their lifetimes,
yes, it was cleared over time, and it was reduced, and it went down as a
power function with time. So that when they were very old, they had
very little left. But they got irradiated almost over their whole
lifetime after initial exposure. And so this means that when you look
at the data from the human studies and the animal studies, they turn out
to agree. And I published this in 1980 in "Science."
They agree very well, and also the mouse studies. What they
show is that as the average concentration of radium in the skeleton gets
smaller, called the dose rate, if you will, the time required to develop
cancer gets longer and longer and longer. Now it turns out it takes
less total dose to produce the cancer at low dose rates. This is what
always confuses people. They say well, you know, lower dose rates are
more dangerous. They look at this. You heard this yesterday. It's
absolutely true. It takes one-tenth as much total dose to reach a point
where there's cancer in people and the dose rate is lower. But the time
keeps getting longer and longer.
Eventually a finite population of people die of age related
illnesses. They die of old age or something else.
When the time required to produce the cancer exceeds the
lifespan, you get no cancers. We are talking about competing risks.
Now if medical science were to extend the life expectancy of
people we would probably have to lower some of our radiation standards,
because what we are talking about to my way of thinking for these
protracted exposures is that in our normal lifespan we don't live long
enough for some of these low doses to have any effect, and that is
exactly what we see in these people and it is exactly what we see in the
animal studies.
They agree exactly and also the distribution of the cases of
bone cancer from radium is not a broad distribution. It is very narrow.
In fact, in the biological system a coefficient of variation
of only 20 percent is kind of a minor miracle, and that is what it is
for the animal studies. It is about 30 percent for the people. When
you plot this up, the average radium in the skeleton versus the time to
development of cancer the coefficient of variation is only about 20 to
30 percent. It is really tight, and all it shows is that as dose rate
goes down people have to wait longer to get the cancer, even though the
radiation is more effective on a total dose basis, but you end up with
this lifespan effective threshold.
But it is real so you look at these people below 10 gray,
200 sieverts, 20,000 rem, over their lifespan -- they don't develop bone
cancer, they don't have any other effects that we can see, and the same
is true in the beagle studies and the same is true with plutonium and
the same is true with Strontium-90 is a low LET radiation. We studied
that at my laboratory and -- non-linear. It is a threshold type
response again.
When I say it is a threshold type response, I don't mean
that there's some dose here below which the risk is zero. I don't mean
that at all.
Okay, so what we are dealing with then is perhaps this
range. Now when I started in this field in the '50s and I went to
graduate school at the University of Rochester, they said oh, we are
going to use this linear model for radiation protection. Now we know
that it is probably wrong but it probably overestimates the risk, so if
we are just going to worry about radiation protection and we want to set
up some standards, we'll use this linear model.
I think the problem came in the '70s when the ICRP started
writing things into some of the reports that suggested that they
believed they could really count bodies with these models, so you use
this linear model.
Now what if we had a standard of 100 millirem per year for
the public and people actually got exposed to an extra 100 millirem per
year for their whole lifespan -- 70 years?
The linear model would predict an increase in lifetime
cancer of about .3 percent -- .3 percent. On the other hand, if you
look at this type of result from these data with several radionuclides,
every one I have looked at comes out this way. It is not a fluke. It
doesn't make a difference which laboratory or which radionuclide. They
all turn out this way.
If this is more representative of those protracted
exposures, then the risk is considerably less than .3 percent, so the
uncertainty we have is somewhere in that range. It is probably lower
than .3 percent. It could be so small that it's almost meaningless --
certainly not measurable.
Now from the point of view of the statistician such as
Charles Land, whom we heard yesterday, if you just go out -- even when
Charlie talked -- Meinhold -- if you just go out and say, you know, you
can't find that, you're right. You cannot just de novo go out there and
try to find a .3 percent increase in cancer rates in the general
population where 30 percent of people are developing cancer. You just
can't find it, so there is no statistical test and no study you are
going to do that makes any sense that will ever find that if it is .3 or
to be able to provide that it is not .3 but .1 or .01 or .001 or 10 to
the minus 20. There is no way that you can do that directly.
So what we are stuck with then is that we have got to look
at what we do know, which is mostly high doses and see if we can figure
out what the processes are involved.
Now why does this occur? Well, to my knowledge nobody has
figured out how to tie together the acute exposures which are much more
effective at causing cancer with the protracted exposures, because we
know that at one sievert we can increase in an obvious way the cancer
rate in people from the atomic bomb survivor data.
These studies with Strontium-90 or radium, we cannot see
anything at 1000 rem if it was spread out over the whole lifetime, but
we know if we give them instantaneous exposure to 100 rem there will be
a 60 percent increase in all kinds of cancers so there is a big
difference, and one of the problems is the model that is -- the paradigm
model that is in the minds of the people we heard who are promoting the
basic linear model.
The paradigm is oh, well, you know, the protraction lowers
the slope. You just need a correction factor. It is still linear but
we are going to lower the slope -- but it doesn't look like it is linear
anymore.
So in other words, we don't understand the mechanism that
gets us from radiation exposure to cancer. If we can't explain these
data as well as the atomic bomb survivor data. If we understood the
mechanism we could explain both sets of data -- so there is a big hole
in our understanding.
As long as there is that hole in our understanding there
will be disagreement among scientists on this issue. I am not sure how
we can get away from that.
DR. GARRICK: Yes. Reaction to the public if they took that
out of context could be very negative.
DR. RAABE: Of course.
DR. GARRICK: That we don't understand the relationship
between radiation exposure and cancer --
DR. RAABE: We don't know the exact mechanism.
DR. GARRICK: Yes.
DR. RAABE: We know that you get -- you expose at certain
levels, you get some increases in cancer.
DR. GARRICK: But it seems that the concept of looking at
the issue not in terms of a threshold but in terms of a curve, if you
wish, that can give us insight on what the likelihood is of getting
cancer is a much more logical representation of the science than the
debate about a threshold.
DR. RAABE: I agree with you. I agree with you. Yes,
absolutely. It is curvolinear, you know, and I mean it's easy to show
that with human data -- now of course the human data that throws a
spanner in the works, as the British would say, is the radon stuff that
we heard, because they fit this log linear model which they call a
linear model and the people who did that really believe that it is a
true model so you have this case where you have protracted exposure.
Now personally I believe that there is an effective
threshold for the radon stuff too but it hasn't been well demonstrated,
and you have these data which are very hard to interpret because of the
uncertainties in dose and other factors.
DR. GARRICK: It also seems that a lot of progress could be
made if we think more in terms of radionuclide specifics about
thresholds --
DR. RAABE: Absolutely. Absolutely.
DR. GARRICK: Than mixes, and this is kind of appealing,
because in the nuclear waste disposal issue we usually end up talking
about a very few, very few radionuclides, and in fact you can almost
generalize it. You can almost say that for low-level waste because more
of it's uranium contaminated than we ever anticipated that the driver
for long-term exposure will be uranium.
For transuranium waste we have seen that the driver over the
compliance period of the repository is principally plutonium. And for
the Yucca Mountain waste, we now know that for periods beyond 10,000s of
years that the driver is going to be things like neptunium-237, with the
early dominance provided by iodine and technetium.
So the truth is maybe we're just not taking advantage of the
characteristics of the problems that we're having to deal with with
respect to getting the most mileage out of what we do know.
DR. RAABE: Yes. And there are some holes in what we know
about those things, too. Plutonium, for example, I've done a lot of
work with plutonium in my career, and I've measured plutonium at the
Nevada Test Site in the fifties, and I've done modeling, and I've made
particles of plutonium, and I've gone to fuel fabrication plants and
studied the plutonium particles that were produced during fabrication
processes, studied the solubility of plutonium in different forms, and
have worked with and was involved in experiments where we exposed
beagles to plutonium particles that we made specifically to find out
about effects on the lung.
And I've modeled the results of these studies.
Unfortunately the studies, they were all funded by the Department of
Energy, and at the time when the last beagles were dying, they took away
the money, so the final complete analysis -- they got more interested in
genome work at that time. So the money got, you know, shifted, because
they thought the genome work had a bigger payoff.
So the analysis was never totally completely done, and data
are still available for that, but I have done these analyses of
plutonium, and again you find this threshold phenomenon, for the same
reason. So I then estimated by a scaling process that I developed what
the human risk would be from inhaling plutonium.
So then I said well now I find some human data to try to see
if it fits the lung risk from inhaling plutonium. There isn't any. Not
in the United States. Because although thousands of people have been
exposed to plutonium by inhalation in the nuclear industry in the United
States, we've got no documented cases of the lung cancer being produced
by anyone exposed below the standards -- or above the standards -- in
the United States.
Now they tell me the Russians are going to supply the data,
and they actually have been, because they weren't being as careful as we
were. And so they had people exposed to very high levels. But those
data are very complicated, because they didn't get exposed to just
plutonium, they got exposed to neutrons and external radiation, gamma
rays, and all kinds of things.
But they have two papers been published out of Russia on
this, and one was published in the Health Physics Journal in December,
and it shows that -- it states in this paper that there were no
effects -- well, I should point out before I get to that that I
estimated that the effective threshold, the place where the risk would
drop quite precipitously, was at about one gray to the lung, which is
about 2,000 rem. So -- because with the alpha particles from plutonium,
but one gray.
Well, the paper that was published in the Health Physics
Journal from the Russian data. They found that below eight-tenths of a
gray they had no effects that they could identify, no lung cancer.
But to confuse the issue, another group at the same
institute published a paper in Radiation Research where they fit a
linear model to it.
DR. GARRICK: Yes.
DR. RAABE: The same data. Fit a linear model to it and
claimed that you could describe it with a linear dose-response model.
Well, that's not new in our industry. The reason that
it works so well is that when you actually plot up the data -- I've done
this many times -- when you actually plot up the data as a function of
cumulative dose and look at the shape, what I call the threshold region
or the region where the risk gets very low is very tiny, it's right at
the origin. It's smack up against it, because all -- it's down there
below one gray, and all the effects are 2, 3, 4, 5 -- and so it gets
shoved over in the corner, and you've seen that on some of these plots
yesterday.
DR. GARRICK: Yes.
DR. RAABE: And it's just a little squiggle, because it's
not caused by the radiation, it's caused by the life-span limitation.
See, it's not -- the radiation is causing this straight line to appear
that maybe it's a straight line, I don't know in this kind of plot, it
looks curvilinear to me, but you can put a straight line through it.
The radiation's causing that straight line. But that little squiggle,
which is the life-span limitation, is caused by something else. People
are dying of old age.
Well, you can draw a straight line through it and it looks
great. In fact, the year that Evans came around the country and
promoted this model, Chuck Mayes and Ray Lloyd took the very same data
and they regrouped it, plotted it on a linear scale, and drew a straight
line and declared there's a linear dose-response. Same data.
DR. GARRICK: It's amazing what you can do with the least
squares fit. You can make almost anything.
DR. RAABE: And it does look good. It looks very good. You
look at it and say hey, yes, that's a straight line. Well, that
threshold there, this is a log plot, that threshold is way down here in
this little squiggle at the bottom, but it's a very important squiggle
if you're only exposing people to a few millirem per year -- or a few
hundred millirem per year.
DR. KEARFOTT: I just have a question for Otto. It seems to
me another source of data, there are the animal data, but another new
source of data, a long-term thing, are the Chernobyl data. It sounds
though like what you're saying is you're not going to see an effect
there anyway.
DR. RAABE: Well, as you know, they have been studying,
looking for effects from Chernobyl, and the last reports I heard, which
were I think a year ago when I was in Vienna, basically said that they
haven't found leukemia that was predicted by the linear model from the
atomic bomb survivor data, they didn't have any of that leukemia; what
they did find was thyroid problems with children. That conflicts with
some other data that's around, but, you know, still it doesn't sound
unreasonable that high doses of I131 to children could increase their
cancer rates, and it's not unreasonable, but I've heard people say that
that data is a little bit hard to interpret too because they don't have
any good baseline information about the number of nodules in the thyroid
and so forth, and suddenly they come in with this team of people looking
at all the children, and so forth.
But I think that's believable, that the I131 exposures to
children did produce this effect. They were high doses, very high
doses. But nothing else has come out of it, and certainly leukemia
did -- they expected it would appear within ten years, you know, they
didn't find it.
DR. GARRICK: I wanted to ask a question. We've discussed
this several times, and I'm becoming convinced more and more of the
problems with it, but one thing that I've never really felt that I could
completely resolve in my mind was we have at all our nuclear
installations since the late forties been wearing film badges and
dosimeters and monitoring ourselves quite carefully and health physics
and radiation protection in the various reactors and also the
laboratories have been tenacious in seeing to it that we do that, and
also supplementing our own measurements with their own measurements in
areas where special kinds of work were being conducted. And yet I get
the sense that this enormous data base is relatively useless.
What seems to be terribly disappointing because it's low
dose, most of it, and it's very population oriented, but I guess it's a
combination of confounding factors and issues having to do with
identifying the individuals and how they died and what have you. Why is
that tremendous data base not more valuable in addressing this issue?
DR. RAABE: Well, the workers in the United States have been
under study at various laboratories, and the Cardis study that
was discussed --
DR. GARRICK: Yes.
DR. RAABE: Is a very comprehensive, complete study, and,
you know, what it showed, we heard some comments this morning about it,
what it shows is that when you really look at the workers, you can't
disprove the hypothesis that there's no risk, and you can't disprove the
hypothesis that the linear no-threshold model is correct, because the
uncertainty, even when they have thousands, tens of thousands of workers
in this composite study, the uncertainty is great. And you saw the data
presented yesterday. There is a couple leukemia cases -- there are two
labs that have high leukemia and the others did not. In fact, at Oak
Ridge leukemia is lower in the exposed people than --
DR. GARRICK: Well, we may not be able to --
DR. RAABE: You know, so it's --
DR. GARRICK: Yes, but --
DR. RAABE: You can't reach conclusions --
DR. GARRICK: Okay. But you did this, you broke the problem
down into a linear problem and a threshold problem. Maybe you can't
address the issue of linearity, but can't you say something on the basis
of this data base about threshold? I mean, the fact that we can't do
anything --
DR. RAABE: No. No.
DR. GARRICK: Suggests to me that there's --
DR. RAABE: What this largest study of these data, the
Cardis study, has shown, international study, is that you can't say
anything about the threshold. You can't disprove the hypothesis that
the dose response is linear, and you can't disprove the hypothesis that
there was no effect at low dose. You can't disprove either hypothesis.
DR. HORNBERGER: Well, it depends on what your null model
is.
DR. RAABE: Beg your pardon?
DR. HORNBERGER: It depends on what your null model is. He
is saying if your null model is no effect, then there is a threshold.
DR. RAABE: Well, I'm saying that the uncertainty, I mean,
you have to compare it to something. So they compare it to people at
high dose or low dose.
DR. GARRICK: Well, there's an uncertainty because you
didn't observe anything. I mean, you didn't see --
DR. RAABE: There's not much happening. That's right.
DR. GARRICK: But to me that's --
DR. RAABE: As Keith was saying yesterday, we don't know the
risk.
DR. GARRICK: What am I missing here? To me that's
extremely valuable information.
DR. RAABE: It is, but it doesn't -- you can't reject the
LNT on that basis, and so you'll always have somebody --
DR. GARRICK: No, but again if I look at it in its component
parts, and in this case look at threshold, rather than linearity --
DR. RAABE: We have a fantastic record of radiation safety
in this country. It's too bad that we can't tell the public about it.
DR. GARRICK: Go ahead.
DR. KEARFOTT: This goes back to what I was attempting to
articulate and which I think Keith Dinger yesterday was trying to do but
were not the right specialist. Isn't there something in risk where you
have a study like this that you can say that the study shows that within
uncertainty sigma that the risk must be less than x under a certain
dose. Isn't there a way you can make a statement like that?
DR. GARRICK: Sure.
DR. KEARFOTT: And isn't that what should be coming out of
this? And why aren't we getting this?
DR. GARRICK: That's my perspective. That's --
DR. HORNBERGER: But again, as Land said, what you're going
to be able to say with that kind of study is an upper bound, and the
upper bound you can't discard the LNT.
DR. GARRICK: Exactly right.
DR. KEARFOTT: Which is fine. That's fine. Who cares?
DR. RAABE: That's why I started off. I said 100 millirem
per year, you can calculate from the ICRP model, three-tenths percent
increase in cancer over the lifetime if someone's exposed to 100
millirem every year for 70 years. It's probably not that high. It may
be effectively zero. We don't know, and we can't prove it.
DR. HORNBERGER: Right. But, see, my point is that, you
know, statistically, if you start with your null model being that the
slope is zero, the data can't refute that.
DR. RAABE: That's right.
DR. HORNBERGER: I mean, that's just an alternate way to
look at it.
DR. RAABE: The data cannot refute that. That's right. You
cannot disprove that hypothesis, that it's zero.
Now, we're not talking at all about -- I'm not talking at
all about any beneficial effects. I mean, if there -- we heard about
beneficial effects, and if there are beneficial effects that affect
carcinogenesis, that will alter the findings.
DR. HORNBERGER: Yes, but most of the worker studies show
the healthy-worker effect. Certainly the Oak Ridge study showed it.
DR. RAABE: I think they all do.
DR. HORNBERGER: They all do.
DR. RAABE: And yesterday we heard that the atomic bomb
survivors showed it.
DR. HORNBERGER: Right.
DR. RAABE: The healthy survivor effect.
I've never gotten an answer to this question, because I
heard this rumor, and I presented it as a rumor to Charles Land
yesterday, and I don't think he bit on it.
DR. GARRICK: I see the jokes now. The bad news is you're
going to be bombed tomorrow by an atomic bomb; the good news is if you
survive, you'll be healthier.
DR. RAABE: Well, --
DR. HORNBERGER: You didn't say that, did you? That's going
to look terrible in the official transcript.
DR. RAABE: The Japanese kept very, very good records of
where people lived, and when they were born, and when they died, they
kept extremely good records. And I heard a rumor that there was a
control group that consisted of people who did not -- were not present
in Japan, or in Nagasaki and Hiroshima at the time of the bombing, and
they decided not to use it, the rumor, because the people -- most of the
people who were exposed had much lower mortality and lower cancer rates.
Now, I have never been able to prove that to myself. I have
never found that. And that is why I asked Dr. Land, and he didn't say
anything against it. He did say there was 26,000 people that were taken
out of the study because they didn't like the way they looked. You
know, as a scientist, I worry about these things. I don't like
censoring the data because you don't like the way it looks.
DR. GARRICK: One of the things I -- oh, excuse me. Go
ahead.
DR. KEARFOTT: Oh, no, it's off. It's a slightly different
topic.
DR. GARRICK: One of the things that, and this is maybe a
slightly different topic, too, but you reminded me of it, that I wanted
to raise yesterday, is that I recall, in the last two or three meetings
we have had on this issue, that one of the arguments given against some
of this data that we are hearing hasn't been adequately considered, one
of the arguments given is that part of the problem is that it was not
done under controlled experiment conditions, or that it was not
supported with a quality assurance standard of some sort.
Is there a way to take old work and put a quality template
on it of some sort and move it out of the zone of not being useful
because of that, and into the zone of being accepted?
DR. RAABE: Every paper I read, I try to evaluate the
quality of it because there are so many things that can happen.
Experiments are very complicated. And I think in some cases, and I
can't, you know, pick -- as I say, every paper sort of has to be looked
at separately. You have to look at the study and figure out what the
potential flaws are. Sometimes there are big ones. And those flaws can
lead to great uncertainties, which makes you doubt whether the results
are meaningful. That is why repeated studies that show the same thing
are so important in science.
You know, we know about cold fusion, for example, you know.
Whatever happened to cold fusion? Well, it wasn't repeatable. And you
could go through the original paper and say, well, you know, it looks
right. Okay.
So, this is the thing, there are all kinds of pitfalls that
even the best scientist can fall into these pitfalls, even trying to be
careful. And so, yes, every time you see a result, you have to say,
well, what -- you know, is this correct, or are there other problems?
And you try to evaluate that. In some cases you can see there are
problems. And, usually, the kind of problems you see, for instance,
animal studies is the author does not tell in any detail how they
selected the controls. That is one of the big problems that occurs in
so many studies. Controls are so important.
In the case control study, you have to know something about
the controls if you want the confounder situation to be stable. And,
typically, you know, I have just got to get on to this, there are lots
of studies that come out. Here is the Rocketdyne study, you probably
heard about this, it made the news last year, out of UCLA, where they --
lots of studies like this, small studies, where they are looking at
nuclear workers, and they are finding, in effect, and they are saying
that radiation is much more dangerous than we ever believed because they
found a statistically significant effect at a very low dose. The
exposure of these people was very small, but there was a statistically
significant effect to higher exposed people versus lower.
And we look at it and say, well, -- and there are lots of
these. There is the Steve Wing paper, several of them. What is going
on here? How -- you know, because this is going to happen. You are
going to see this kind of alternative paper in the literature. I am
sure this is published in some statistical journal now.
Well, there is a big problem with these epi studies. The
problem is that the confounders are very difficult to work with. The
other kinds of exposures that occur are very difficult to quantify, and
when the study is done, the only good measurements that the researcher
can find about these workers is the radiation exposure, because it has
been documented perfectly. You know, if you are doing any kind of
fitting of data which has multi-factorial data, one of the principles of
regression is the measurements that are made with the greatest precision
tend to dominate the response, even though other factors are actually
causing the response. So you get the impression that the best
measurements have a cause-effect relationship when all they have is an
association that is related to the way which they are done.
But we have -- okay, what are the confounders? Well,
cigarette smoking. In this case, I talked to the author. He based his
conclusion on four cancer cases in the high dose group. One was a
Hodgkin's lymphoma, which is not believed to be radiation sensitive
anyway, one was leukemia, and two were lung cancers. And I said to the
man, the two that were lung cancers, were they cigarette smokers? And
he said, I don't know. Well, what about cigarette smoking? Well, we
took some side groups and we tried to balance it and it looked like
about the same number of people were smokers in the control group as the
exposed. But he didn't -- but they didn't do it, it was a side study.
They didn't actually do it in the main study.
So he was basing this -- you know, okay, well, the principle
of confounders is that if your control group has the same percentage of
smokers, obviously, there is also dosimetry there. How much do they
smoke and so forth? But if they have the same number, the
biostatistician thinks he has got it covered. But if there is only four
cases, or two cases that you are dealing with, forget it. The normal
proximation doesn't work for two cases.
DR. HORNBERGER: If there are four cases in the high group,
how many in the low group?
DR. RAABE: Oh, well, there are lots, I have the numbers.
DR. HORNBERGER: No, no, no. But four cases --
DR. RAABE: A lot. Lots. But the low group is a big group
of people and the high group is only 20, or 17 people.
DR. HORNBERGER: Gotcha. Gotcha.
DR. RAABE: But this comes out, you know. They had a big
press conference. Let's see, they -- I don't have them all here, but
they had a big press conference over, you know, 17 workers, two cases,
in the high group. Three cases in 210 workers, lower down, and six
cases in 723, and then at the lowest group, three cases in 1,333. Well,
that becomes statistically significant -- two cases in 17 workers.
Well, you say, well, okay, well, leukemia is involved there.
Well, what about their exposure to organic solvents? Well, we didn't
measure that. There are no objectives for that, we couldn't figure that
out. Did they smoke cigarettes? Well, I don't know, we don't know.
Did those two cigarettes? We don't know. Didn't you look? No. But
this makes the news.
Steve Wing came out with a study that was the classic in
epidemiological fishing expeditions, where you look through all of the
data, you know, 40 different kinds of cancer, and find one that seems to
be increased with dose. This was multiple myeloma that he found.
Actually, it wasn't increased with dose, which is kind of interesting.
There's four labs. He took Battelle Northwest, Oak Ridge, I think -- I
am forgetting what the other two labs were, but he had four DOE
laboratories that he was working with. And he look at this multiple
myeloma.
Battelle Northwest, in 1979, Ethel Gilbert reported that
there was an anomalously higher level of multiple myeloma in workers at
Battelle Northwest. This didn't occur anyplace else. And you can have
all kinds of random things happen with 40 different kinds of cancers in
your list.
Well, so, he had this as a starting point. And when he did
the case control study, he found no radiation effect on multiple
myeloma, but that didn't stop him. Then he partitioned the people into
the age at which they started working, only he grouped people lower than
40 years and higher than 40 years. Bang! His computer program gave him
a significance. And he ended up making a videotape that was shown to
all the workers, you know, I am saying, you know, you have got this
higher risk of multiple myeloma.
You know, so, on the other side, I mean we have to -- we
have got one side here with people coming in and saying, well, you know,
radiation is really not that dangerous and maybe even beneficial
effects. Then you have these other papers coming out from scientists
who are recognized in way or another saying, oh, it is even worse than
we thought. So that goes into the pot.
What does the public hear? Well, the public heard this.
They had a big press conference. It made all the newspapers in
California. The public heard about Steve Wing. They hear these things,
you know, multiple -- you know, this cancer occurs up there. And the
workers all had to watch this tape to tell them that they have an
increased risk. It is a faulty study, it is very obvious.
DR. GARRICK: While we have you here, because we have to
break for lunch here pretty soon, but what in your opinion, both of you,
has been the most important advancement made in, say, the last five
years in the arena of understanding low dose response, if anything? If
you want to pick a different time period --
DR. RAABE: Twenty years?
DR. HORNBERGER: Well, that answers your question.
DR. GARRICK: Yes.
DR. RAABE: If you go by the NCRP's newest report, there
hasn't been much new because they basically are saying --
DR. GARRICK: Because this seems to be a point of debate
too, between the LNT supporters and the nonsupporters, where the
nonsupporters seem to think that there's been quite a bit of work done
that would be evidence of a nonlinear --
DR. RAABE: Some of the studies that are cited by some
people who say that you can't believe the linear no threshold are
studies that just show you can't discount the possibility of no risk.
They don't disprove the linear no threshold and there is a big
difference between saying your statistics are such that I can't rule out
zero and saying that LNT is wrong.
Of course the Cardis study is the biggest one that has been
done with the most workers that I know of in one study and I think very
carefully done overall in terms of the epidemiology and the best
biomathematical methods, and I know Ethel Gilbert personally. I think
she is a very good biomathematician. She was involved in that.
And what do they show? And I heard Ethel Gilbert -- they
say, well, I am repeating myself, it doesn't show anything particularly.
I mean we have a very good record. We can't prove or disprove anything
within the limits of statistics. They do believe there is a leukemia
effect but when I look at leukemia effects and I see it is not
consistent, it only occurred at two places, one in Canada, one in
Europe, didn't occur in the United States, sounds like it wasn't
radiation. Sounds like a confounder.
DR. GARRICK: Charles?
DR. FAIRHURST: A couple. In that period what has been the
support? Is there support gaining for hormesis or is that something
that was not considered significant 15, 20 years ago and it is seemingly
getting greater attention or greater credence?
DR. RAABE: Well, I don't -- I haven't personally worked in
the area of hormesis. I work with data and try to fit models and so
forth. Now sometimes you see things that look like a beneficial effect.
Yes, the dogs in our studies with Strontium-90 that lived the longest
were the ones in the lowest dose group.
DR. FAIRHURST: But we are talking about advanced in the
last 20 years. Is there a scientific sort of credibility growing or
greater evidence that it is real based on basic mechanisms or basic
understanding?
DR. RAABE: There are a number of studies that have been
pointed up in the last few years that suggest a beneficial effect of --
DR. FAIRHURST: That is what I was pushing Art Upton about
yesterday and he seemed to agree to it.
Could I ask quickly the other question? It seems to me that
you alluded to it yesterday somewhat. This great variation in
background, and seemingly no effect, I mean what can you do with that?
Apparently you can't treat it statistically but there must be some way
that evidence shows there's a variation.
DR. KEARFOTT: That background is extremely variable.
DR. FAIRHURST: I agree --
DR. KEARFOTT: Hundred foot dimensions --
DR. FAIRHURST: With no apparently correlation to cancer.
DR. KEARFOTT: That's possible.
DR. FAIRHURST: That is what I am hearing.
DR. RAABE: Well, let me give you some real numbers, okay?
I did the calculation for the 100 millirem per year, okay? Most of us
get about 300 millirem per year, so that would predict about a one -- if
you believe the linear no threshold, if you believe it is the upper
limit that would predict, upper limit of about 1 percent lifetime risk
from cancer from this background level.
Now the average person in the United States, what? -- 35
percent of the people get cancer? You can't find that in the noise. I
mean if you go to Utah, where people don't smoke very much, the cancer
rates go way down but their radiation level goes up. Well, even if
there was a special increase of a couple percent in their risk due to
the radiation, the drop in 10 percent that occurs because they don't
smoke overwhelms that.
DR. FAIRHURST: Right.
DR. RAABE: In Colorado the average dose to people,
effective dose to code, is about 900 millirem, about three times higher.
Colorado is 48th in cancer in the United States. I have the numbers
here if you want to see them.
Lung cancer, Colorado is down. Only Utah is lower than
Colorado in lung cancer. Most of this extra dose is from radon and Utah
is down there. D.C. is 48 cancers per 100,000 and Colorado is 35 --
this is lung cancer in 1995.
So let's take the 900. Well, that would predict about a 3
percent lifetime risk of cancer. We are still looking at this
background level. It is lower in Colorado than here but I don't know if
you could statistically ever see if that 3 percent were real. Can you
see it amidst the confounders?
DR. FAIRHURST: Yes, but can't you come to a conclusion that
given all of the cancer-causing agents that are bounding in the world
today, radiation is not a significant component.
DR. RAABE: Absolutely right. Even if you believe LNT.
DR. FAIRHURST: The public heard that.
DR. RAABE: Even if we believe LNT, the people who are
arguing LNT are arguing for a very low risk and low dose and the people
who are arguing other things -- are arguing for a lower risk.
DR. FAIRHURST: But can I turn it another way and say you
are throwing billions of dollars at the LNT hypothesis or protection
against radiation and say for god's sake put that money into stopping
people from smoking.
DR. HORNBERGER: You're too rational.
DR. FAIRHURST: Commissioner Dicus yesterday said what is
the public willing -- if they are willing to pay it, we'll pay it. I
think we are not serving the public by not -- I think it was one of your
points -- I know your risk information and risk doesn't work but there's
got to be some way you can inform the public of the stupidity of some of
these allocations. Maybe I am still --
DR. RAABE: One response I have gotten from the public, I
like to use comparisons. The risk of a few extra millirem is the same
risk as moving up a thousand feet, you know, so you if you move to the
mountains you are going to get the same dose, but in a discussion with
the public one thing I wanted to bring up was if you come up with these
numbers, these numbers that we play with, they are pure speculation,
mind you.
The Health Physics Society is right. Below 5 rem you cannot
come up with a quantitative value that doesn't have such gigantic
uncertainties that it is almost meaningless, but if you take these
numbers to the public and say well, you know, the risk is only
three-tenths of a percent of getting cancer -- "Well, what about those
people who get the cancer?"
DR. FAIRHURST: Oh, sure. Sure.
DR. RAABE: That is what I have been told -- but what about
those people who actually get those cancers?
DR. GARRICK: Just to push Charles' proposal a little
further, if you took a place like Central City, Colorado, where --
DR. HORNBERGER: Where some of us have claims.
DR. GARRICK: -- where some of own mining property --
[Laughter.]
DR. GARRICK: -- and it's 1000 millirem or whatever, and
another similar location, similar population, full time residents of
course, where it is about 100, are we saying that we still couldn't
control the analysis well enough to do a credible comparison?
DR. KEARFOTT: Only a good epidemiologist I think could give
you that answer.
DR. GARRICK: Yes.
DR. RAABE: Yes, you are asking an epidemiological question.
The question is whether you can do a case control study
where you can control enough factors to reduce the background level or
to control for the background level of cancer and we know about
cigarette smoking. That is easy. But we don't know about other things
and so I don't know. That is an epidemiological question.
DR. KEARFOTT: But it sounds like a hard one.
DR. GARRICK: But they have pretty good information on some
of these things, like you say -- like cigarettes. We seem to know
everybody that smokes in the United States.
DR. HORNBERGER: Yes, but my suspicion is that perhaps if
Central City were the size of New York City that you might have a chance
but when you have a few hundred people living in Central City, even on
the sample size basis you are going to be really -- it's tough, and that
is not the hardest part of the problem.
I still think they have these controlling for lots of other
things.
DR. GARRICK: Well, it's unfortunate that we have a
phenomena that is so easy to measure as radiation and we have so many
measurements as we do on it that we can't do a better job of answering
some of these questions, but I guess you have convinced me of the
problems.
All right. I guess the other thing I would ask is sort of
in closing of this session are there any other comments that you would
like to make, nuggets that you have rethought?
You have given us an excellent discussion of what you have
observed from the discussions of the last day plus, and it looks like it
is pretty much now up to the committee to figure out what we want to say
about this, but before we do adjourn this segment, I appeal to you if
there is any other parting observations or comments that would help us.
DR. RAABE: I would like to repeat one thing that I
mentioned in passing. You asked earlier if we needed another study.
DR. GARRICK: Yes.
DR. RAABE: If someone said, you know, do you need another
study, I'd say well, you know, I would really like to see a study where
the Committee has a charge to look only at protracted radiation and try
to piece together all that you know about protracted radiation exposure.
I think that's the target of our problem, it's the source of our
problem.
I also like the idea of doing some targeted analyses of
specific radionuclides.
DR. GARRICK: Yes.
DR. RAABE: All that we know about plutonium, and don't
leave out the animal data, because there isn't any human data. It
always puts me in shock that we spend all these multimillions of dollars
on very elaborate animal studies, and when you read the reports that are
being produced, to a large extent that information is not used.
DR. GARRICK: Yes.
DR. RAABE: And usually it's this hidden idea well, you
know, human data is more appropriate, you know, animal data is animal
data, you know. So although the animal data are really well controlled
and the human data are not, and the animal dosimetry is very precise and
the human data dosimetry is very imprecise, to not use the animal
data -- anyway, that was my main thing about the protracted and the
targeted radionuclide.
DR. GARRICK: Kim.
DR. KEARFOTT: I tend to be naively optimistic in that there
must be some opportunity, somewhere, to break the box. And I was very
sort of captured by Dr. Fairhurst's comments about the public and, you
know, can't you do this another way. So somehow there has to be a way
of taking a different approach to analyzing and presenting the data that
we already have and have a truly independent group figure out how to
synthesize things. And I think that's the only way we'll break a box in
which one of the walls in the box is the public and the other wall in
the box are the technical people.
DR. GARRICK: And I think that complements exactly what Dr.
Raabe just said, and all we have to do is figure out who.
DR. FAIRHURST: Could I throw out --
DR. GARRICK: Yes.
DR. FAIRHURST: One even more extreme thing. You, I've
actually talked -- do you know a fellow named Crowe at the University of
Wisconsin who is looking at projections? It's always interesting to me
to see how people project data, et cetera, and if it has a negative
effect, you keep it in, and if it seems to have a positive effect, you
say well, you know, that's a bit too -- let's push it out, because --
one of the things that's interesting, that if you're -- there's a big
stimulus now to do fundamental biological research on the causes of
cancer or the effects on DNA, et cetera. Now presumably if you discover
this research is fruitful, not only will you be understanding perhaps
the causes of cancer, but possibly ways to reduce its impact, or I
wouldn't call it a cure, but somehow to put preventative. And so -- and
the next thing of course is, as you say, that people ultimately die of
old age, and if you push the age out, presumably you're eliminating
other diseases and leaving one of the most intractable cancer to -- tend
to increase the percentage of people dying.
But if you start using similar sorts of logic, if you like,
or illogic, to extend, what's the reality that the causes of cancer will
be a major component of a problem 50 or 100 years from now? Do you see
what I'm saying? If we are pushing this research, and it should be
done, and if it's successful, then you're eliminating the problem, or
partially the problem, even if you do have -- you find out that there is
a high consequence of a dose 50 years from now, you may be able to offer
that person some remedial treatment. And I'm trying to figure out how
you put that into --
DR. RAABE: It's sort of like the case with thyroid
exposure. We know that people might have gotten high doses of I131
years ago, but thyroid cancer's almost 98 percent curable. Is that what
you're saying?
DR. FAIRHURST: Yes.
DR. RAABE: And presumably for other kinds of cancers there
are going to be even more fantastic methods for treatment.
DR. GARRICK: In fact, the health effects models that we've
used before the NRC got into the risk business were based on essentially
that, that 90 percent of the thyroid cancers were recoverable.
It sounds like the ode of the radiation researcher is to
want to live long enough to have died from radiation-induced cancer.
[Laughter.]
DR. RAABE: When I give the talks on the studies I did with
internal radionuclides, I always point out that if you removed all other
causes of death, you would eventually die of radiation-induced cancer.
DR. KEARFOTT: I just wanted to comment that the treatments
depend on understanding of the mechanisms, and so that's why I support
continuing sort of biological research, because that's where those
answers are going to come from.
DR. GARRICK: George?
DR. HORNBERGER: Yes, a question again, sort of a
hypothetical -- well, it's not hypothetical, but it follows a little bit
on what Charles said.
One of the things that we're grappling with right now is of
course Yucca Mountain, and here we're talking about setting standards
out at 10,000 years and beyond. Currently the draft standards call for
a 25-millirem all-pathways standard, and as you've heard, there are some
arguments with EPA as to whether or not that is or isn't the right
standard. Could you just give us your -- even if it's a gut-level
feeling -- on what a standard -- a reasonable standard, radiation
standard, should be for that kind of problem over that kind of time
frame.
DR. RAABE: Well, there is no basis for saying that 25
millirem is different from 15, that is for sure.
The Health Physics Society's position statement is that you
can allow 100 millirem per year, and I stand with that. I don't think
there is any known or expected risk at all. Protracted exposure --
DR. HORNBERGER: So, 100 millirem at 10,000 years, that
seems reasonable.
DR. RAABE: Sure.
DR. GARRICK: All pathways?
DR. RAABE: All pathways?
DR. GARRICK: Yes.
DR. RAABE: Yeah. I don't think there is any known expected
risk associated with that kind of exposure.
DR. KEARFOTT: I also support Health Physics Society's
statement in there.
DR. FAIRHURST: You know that the significance of that with
Yucca Mountain is that DOE's own studies show that the risk is -- or the
does is rising beyond 10,000, even though we set our standard at 10,000.
And so the public is going to go jumping through the roof if you, say,
set it at a time when it is not the worst.
DR. KEARFOTT: I have a terrible problem with this whole
sort of long-term waste stuff, and that I view internal dose assessments
and the number I can give for you next year has an order of magnitude
uncertainty in it, when you take everything into account, and then you
tell me to extrapolate 10,000 years, I mean that is the problem I have
with all that.
DR. GARRICK: Well, that is a valid problem. What I would
like to do is invite our consultants to enjoy this afternoon with us if
you like, in a slightly different position. We are going to hear some
presentations on the clearance rule and also on the decommissioning
standard review plan. I don't know what your travel plans are. I just
want to indicate that you are welcome to be here if you are going to
still be in town.
Any other parting comments before we adjourn for lunch?
This has been an excellent session and I think it has coalesced a number
of ideas and points that gives us a basis for trying to work up some
sort of rational report.
Dana, have you got a parting remark?
DR. POWERS: I guess maybe a couple of questions. One
question, a lot of research was outlined that could be done. Have you
any idea why it is that the industry that bears such high costs is not
an active sponsor of research in this area? The second question would
be, have you seen anything that refutes the logic that we can set a
standard of what is safe enough, utilize a linear hypothesis that may or
may not be bounding, and set risk standards based on that?
DR. RAABE: The first question was --
DR. POWERS: Industry.
DR. RAABE: The industry. I don't know anything about that.
DR. KEARFOTT: I suspect that it might be because industry
doesn't want to fund very long-term purely scientific research,
particularly an industry whose main focus is power.
DR. GARRICK: Why don't we ask Ralph to make a comment?
What you got to say about that, Ralph?
MR. ANDERSON: My name is Ralph Anderson with the Nuclear
Energy Institute. I am sorry I couldn't join you this morning, I was
very busy at our offices help prepare our final testimony on
appropriations for this year for DOE and NRC, and the reason I had to
stay behind is because we were completing our section of the testimony
that is supportive of the DOE research funding and encourages continued
research in this area.
So, first of all, I think the statement is incorrect. And,
in fact, last year and the year prior, we had many interactions with
Senator Domenici's office in which we were very supportive of his vision
for research in this area. So I think that is a misunderstanding of
industry's position.
Also, through EPRI, which is our research arm, we have, in
fact, invested money in the past to do feasibility studies of
epidemiological studies, and primarily because of economic reasons, and
because we also reached the conclusion that the studies would not be
definitive, we determined not to go forth. But I think that is
reasonable in any mode of research, you don't proceed with research that
you don't expect to be fruitful, especially at a potentially high cost.
So I think that there is a misunderstanding of industry's position on
such research.
DR. KEARFOTT: The second question --
DR. POWERS: Am I misunderstanding that you are not funding
any research in this area, especially this litany that was given to us?
MR. ANDERSON: I beg your pardon?
DR. POWERS: Am I misunderstanding that you are not funding
research, especially in this litany of research suggestions that we have
had?
MR. ANDERSON: When you say we funding, I am not sure what
opportunities for funding we specifically have.
DR. POWERS: Well, it seems to me that there are apparently
a large number of people in the academic community wiling and anxious to
conduct studies ranging from cells in petri dishes up to epidemiological
analyses.
MR. ANDERSON: I am sure that is probably true, having
worked once upon a time in the research community, and not to make light
of what you say. I suspect there are probably thousands beyond those
that we are aware of. If you are suggesting would we directly fund such
research through the universities, I suspect not. We might encourage
such funding through federal funds, and let me tell you why.
What we ascertained in '92 when we looked at going forth
with an industry funded large scale effort on epidemiology, one of the
conclusions that we reached after talking with a lot of the people who
were so-called stakeholders out in the public community was that any
study that we funded would be found highly incredible unless the results
were that all radiation kills all people. And so, in that sense, we
have done indirectly, we support the NCRP, we have for years. We have
given money to specific efforts at NCRP. As I mentioned, we have
supported primarily literature reviews through EPRI, subsequent to our
'92 decision. And then we work through the Congress, because we think
that an understanding of the issue actually is a little broader than,
quote, "just the industry." We think in the public interest to have
better answers to the questions. And, you know, we have been very
supportive of research through federal monies.
But I think we would shoot ourselves in the foot if we were
to try to pass money directly over into the research community. It just
seems to pollute the well. I would be happy to talk further about it,
but that's --
DR. GARRICK: Okay. I think we want to -- I guess, James,
you have one final --
MR. MUCKERHEIDE: Over the last 20 years or so, I have
talked to the industry about funding research. It has always struck me
as very surprising, but quite rational why industry does not research.
As a regulated utility environment, two things were fundamentally true.
In their regulatory process, they got some money to support EPRI in the
early days, but compared to chemical industry or oil industry, or any of
the other private industries, they didn't have the same approach, nor
did they have the same incentives.
Number two, they were party to a government ownership,
essentially, of the nuclear enterprise. They were licensed and
regulated under very rigid conditions, the ownership and the
responsibility under the licensing regime, and the authority for
byproduct materials and lots of other issues were all very -- pretty
much closely hidden by -- held by the government, and so there wasn't a
sense that there was something to do.
Thirdly, it was very clear that if we have to spend a great
deal of money to meet a requirement, we pass it through to the rate
payer, so some of the issues that we addressed in the '70s and in the
early '80s were pretty much set aside as, well, if we have to pay
another $100 million, we just put it in the rate base.
And, finally, in more recent times, I think if we begin to
see this industry become more privatized, the potential that they will
join the arena of industries that actually fund research, I mean we have
a chemical industry Institute of Toxicology. There is no nuclear
industry Institute of Radiobiology. There is an entire world of
programs that chemical industries and other industries fund relative to
their own self-interest, but being a quasi-governmental regulated
enterprise, primarily, it just never really was in their interest. So I
think one of the things we hope to see change is under the new tendency
to be more privatized, that the interests will begin to revert to having
more self-interest and seeing long-term research and long-term interests
come to the fore.
DR. GARRICK: Yes, and I think, fundamentally, unlike the
chemical industry, the automobile industry, many other industries, the
nuclear power industry had its beginning in a government arena where
most of the research was performed by the government.
Okay. I think we will break now for lunch.
[Whereupon, at 12:05 p.m., the meeting was recessed, to
reconvene at 1:02 p.m., this same day.]. A F T E R N O O N S E S S I O N
[1:02 p.m.]
DR. GARRICK: The meeting will come to order.
We are now going to shift into a little different area of
activity. We are going to hear about the Clearance Rule and also about
the Decommissioning Standard Review Plan this afternoon.
It is my understanding, Frank, that you are going to lead
off the discussion and I will look to you to introduce the subsequent
speakers, okay? Frank Cardile.
MR. CARDILE: Go ahead and put the next slide up, Giorgio.
Basically this is just an introductory slide on page 2. We
are here to talk about -- we are here to kind of lay out the progress of
where we are in development of a Clearance Rule, basically, as it
indicates here, give some background, indicate where we are, the recent
activities that we have gone through and completed, what are our
upcoming steps, what is coming up next that we, the activities that we
are going to be conducting.
Then we will get into some specifics of an issues paper that
we have completed and that we are going to be sending on to the
Commission shortly, and then Tony Huffert, to my left here, will discuss
some particulars with regard to development of a technical basis that we
are going to use to support any rulemaking effort that we get into.
We are trying to let you know where we are. We have made a
lot of steps here fairly recently and we have got a lot of steps going
on in the next few months and year and we want to let you know what is
going on.
On the next slide, on page 3, to give you some background on
how we got to where we are, in SECY-98-028, which was sent up about a
year ago in February of 1998, the Staff went to the Commission and
requested Commission guidance or direction on three options for how we
should proceed with regard to clearance, that we could either continue
with our current regulatory structure, which basically relies upon the
use of regulatory guidance, or we could support EPA in their efforts at
issuance of a standard on clearance, and then follow them up by issuing
a conforming rule or we could proceed independently to issue a NRC rule
for NRC licensees.
The Commission came back in June of 1998 and directed us to
proceed with the third option that you see up there, the third bullet,
and that we should promulgate a dose-based rule on clearance, we should
begin in FY 1999, and that we should use an enhanced participatory
rulemaking process similar to Part 35, the process that they have gone
through and also similar, although they didn't mention it or they didn't
specifically delineate it, similar to the process that we went through
on the decommissioning rule or the cleanup rule in 1992-93 timeframe.
So with that direction, if you go on to the next slide, on
page 4, the Staff received that SRM in June of 1998 and proceeded with a
number of steps to get started and then on January 27th of this year,
1999, we sent up to the Commission a SECY paper, SECY-99-028, describing
to them our rulemaking process that we envisioned for clearance.
Included in that process, and not specifically noted on the
slide here, is that we were forming a working group and a steering group
on clearance, on the clearance rulemaking effort. The purpose of the
working group and steering group is obviously to assist in the
preparation of the document. The working group would be made up of
working staff from NMSS, NRR, Office of State Programs, OGC, and
Research. Obviously this is a wide effort going across both licensing
offices, NRR and NMSS, also the Office of Research plays a role in
assisting with the development of the technical basis to feed into the
rulemaking.
OGC of course provides the legal input and OSP provides
input with regard to compatibility and other areas.
The steering group -- in addition to those members of the
working group we also have a working group member from an Agreement
State, from the state of Texas. We also set up a steering group made up
of management from those particular NRC offices to give us early
management direction on some particular areas and also to expedite the
concurrence process.
This working group-steering group process has been used and
was used also on the cleanup rule, which was completed a couple years
ago.
We also have a steering group member from the state of
Illinois, an Agreement State, so we have some state representation on
this panel, on both of these panels.
We also are proceeding with not only -- as part of our
rulemaking process not only the standard rulemaking procedure but we
also, as the Commission directed us to do, are supplementing the process
with an enhanced participatory rulemaking process the object of which is
to obtain early and meaningful public input into any rulemaking that we
would conduct.
As noted there then, on the first bullet, really this first
bullet describes some of the specific plans with regard to this enhanced
participatory process. Two of the key components of that process are
that we would publish an issues paper in the Federal Register. I will
talk about that some more as we are going on to the next slide.
Basically this issues paper will go out there and be
published in the Federal Register and its intent is to foster discussion
on the issues associated with any rulemaking early on, so that we
know -- we can get some information.
We also hold four facilitated public meetings at different
geographical locations. We anticipate those beginning in August of this
year and going through November of this year. Right now we anticipate
those meetings being in Chicago, Atlanta, San Francisco, and Washington,
D.C. The last one would be in Washington, D.C.
We would invite the ACNW members to attend any of those
public meetings and in particular we also anticipate that in the
timeframe of those public meetings, either in amongst them when we can
reflect what we have been hearing, or perhaps when we are done with --
when we are completed with the public meetings we would hold a meeting
with you to go over your views on the specific content of the issues
paper.
The idea -- you may be familiar with a facilitated meeting.
The idea of facilitation is to not only just hold a meeting and say what
are your views, but to broaden participation to make sure that different
views are represented and to make sure that the view that are
represented are presented at the meeting, so it is not just open up the
door and hold a public meeting but there is a process that we go through
prior to that where we invite specific interests and then we let them
know early on what the questions are and bring these interests into the
meeting.
We are in the process right now. That process of
facilitation will be one in which we both contract out some of that work
and also use a person here, Chip Cameron, who has done this type of work
at Part 35 meetings prior to this.
The second bullet on the page, going back to the content of
that Commission paper, we discussed the specific technical basis that we
will still need for this rulemaking the schedule for developing that
technical basis.
Tony Huffert later in this paper, Section 4 your notes here
today, will be talking to some of the details about that technical
basis.
In broad terms, we are right now in the process of getting
on board the contractors that we need to assist us in that process. We
plan to have those contractors on board -- there's four separate
contracts and four separate contractors. One is a competitive bid. One
is a task order on an existing bid. Two are with Government contracts.
But we plan to have them all on board and running shortly and certainly
completed by either June or July of this year that they would all be on
board.
Finally, the last bullet on this page, the SECY paper
indicated that following completion of the public meetings that in
probably February of next year we would bring the Commission another
paper indicating the results of the meetings, where we stand on the
meetings themselves, and what we learned from those meetings, and then
also where we stand on the development of the technical basis and where
we would go from there.
Okay. The next slide as the first order of business are preparing this
issues paper. The point of the issues paper is to, as I said, foster
discussion on the issues before we would get into any rulemaking.
This paper has been completed. It's currently in NMSS
office, concurrence process, the various offices and the steering group
members have concurred on the paper. We plan to send it to the
Commission for information this month, and then we plan to publish it in
the Federal Register for public comment next month, in April. We would
invite written and electronic comments on it. We will indicate in it
how it can be obtained, both electronically and how paper copies can be
obtained from the staff.
The comment period of the paper will remain open until of
course the last public meeting in November, and then we would also note
in the FRN notes that the issues paper not only being available for
people who have sent in their written comments but it will be the format
of holding the public meetings.
Following the public meetings of course we'd be in a better
position to decide what direction to proceed.
So getting into the details of a little bit of what's in the
issues paper, on page 6, the next couple of slides, what we did in the
issues paper is we had a background section in which we try to lay out
in as direct and clear a manner as possible where we are now, why we're
doing what we're doing, why this is different than what we've ever done
before, and what we plan on doing, some of the context of why we're
doing what we're doing. That's Part A of the issues paper. Part B of
the issues paper is ask some specific questions -- it raises four
specific issues, lays out alternatives under each issue, and then asks
some specific questions to foster discussion in these public meetings.
So this first page here that you see, page 6, is part of the
background, discusses some of the rationale for why the NRC is
considering rulemaking in the area of clearance. Basically it notes
that Part 20 already contains criteria on the amount of radioactivity
and gaseous and liquid releases that may be released from a nuclear
facility to the environment. Also subpart (e) of Part 20, which was
recently added, has criteria on the release of decommissioned lands and
structures.
This part focuses on protection of persons -- focuses on
protection of persons coming on the site and using a decommissioned
structure or using decommissioned lands after license termination. It
does not focus on release of metals or other equipment or other things
from the decommissioned structure to the public. So it was focused on
the structure and the lands.
However, unlike -- like I point out here, the existing
criteria for liquid and gaseous releases and lands and structures, there
are no specific criteria in Part 20 governing releases of solid
materials. Now I don't get into this here, but the issues paper
discusses in some amount of detail or provides some information about
what these solid materials are. It notes that the solid materials are,
for example, metals, equipment, furniture, and any other material that
could be at a nuclear site.
It also points out that some of this material would have no
radioactive contamination, for example, many, many of the NRC licensees
or sealed-source users have equipment and materials that have no
contamination because their source is a sealed source and there's no
contamination on site. But it points out that other materials obviously
at some other facilities can become contaminated because they're in
perhaps like a reactor facility or a laboratory facility where there's
contamination which may leak from a pipe and particular equipment may be
there and become contaminated, or obviously if a piece of equipment is
part of the radioactive system, like a tank or piping or pump systems,
those would obviously become contaminated. So the paper tries to point
out that there's a difference in levels between the amount of
contamination that any particular piece of material can have.
The bottom line or the bottom tick on this page is that the
Commission's thought is that in order to provide -- the rationale is
that to provide consistency in the framework for releases of all
materials we're considering this rulemaking.
This would put us in a better position to avoid
inconsistencies between standards and also allows us to deal with
requests from licensees, especially in the future. As more facilities
reach decommissioning, there may likely be increased requests for
clearance.
On the next page, on page 7, again this is more background,
the issues paper notes that anytime the Commission proposes a rule or
considers proceeding towards rulemaking, it considers alternative
courses of action. Three of the courses that we lay out in the issues
paper as possible courses of action, and again this paper is intended to
foster discussion. It says that these are the things we've thought
about based on our knowledge that we have, and obviously this is a
jumping-off point for anyone else -- or for anyone to say either changes
or suggestions or permutations to these courses of action.
Basically the three alternatives that we lay out are permit
release of the materials for unrestricted use if potential doses are
below a certain level. This level obviously would be worked out during
the rulemaking process. The process that we've been using this word
"clearance" and "unrestricted use" back and forth a little bit so far
today, and it has been used back and forth.
As you may well know, internationally the definition of
clearance is release of material for unrestricted use, so that clearance
would be restricted to the -- or would be used for this first
alternative. Because this rulemaking is proposing or this effort is
proposing alternative courses of action besides just unrestricted use,
we have to be careful not to just call the whole thing clearance. But
anyway, unrestricted use or clearance of materials could include recycle
or reuse of this material into either consumer products or industrial
products, or you could just release material for unrestricted use and it
could wind up in a landfill.
A second alternative that we note is that perhaps rather
than just putting the material out for any use, we could restrict its
use to certain authorized uses which would probably result in the public
receiving -- the general public receiving lower doses.
And a third possible option is that neither unrestricted nor
restricted use would be permitted, but any material that had been in
radioactive service or had become contaminated because it had been in an
area where material was used -- licensed material was used or stored
would just not be permitted to be released. This is a third option
which we indicate in the paper.
Going on to page 8, again in background this is something
that we obviously are aware of.
There have been previous Commission efforts to address
release of solid materials. In particular the BRC policy from July
1980, you know, you can read the details of what the BRC policy was
intended to do, but it basically was a broad policy statement saying --
put out as a way around which to formulate future decisions regarding
regulations or licensing decisions.
It has four principal components, one of which was
decommissioning lands and structures, and another one of which was
setting a standard for release of solid materials for recycle. Notice
that it only talked about recycle, didn't talk about clearance in
general, which can mean also general release or where material could
wind up in a landfill.
However, based on, you know, public concern with this
policy, some of that public concern being just the nature by which it
was developed and some of that public concern being the content of that
paper, the Commission decided that a more extensive public involvement
process should be followed with regard to the policy, but before that
larger process could occur, the -- and so the Commission put a
moratorium on the policy. Before any additional work or public
involvement could be conducted, Congress enacted the Energy Policy Act
of 1992 which revoked the BRC policy statement.
Moving on to the next, on page 9, continuing with regard to
the BRC policy, it's our thought that what we're doing now is not just
the BRC policy -- that was a broad policy-setting approach -- this
effort would aim at establishing some specific requirements and would
aim at using the procedural requirements of the Administrative
Procedures Act or the APA, as noted in the second check here. The APA
of course requires us to go through the NEPA process, which would
include an evaluation of the environmental impacts associated with any
clearance rulemaking, which would include a full assessment of potential
scenarios and pathways of exposure by which people might become exposed
to clearance pathways.
The APA or our process also involves doing a regulatory
analysis consistent with Executive Order 12991. And as a supplement to
the EPA process, we would conduct an enhanced participatory rulemaking
process. This APA/EPR enhanced process was conducted in a similar
manner following -- has been previously conducted -- following the BRC
policy being revoked, one of the components of that policy, namely the
decommissioning lands and structures component, was -- we went through a
rulemaking -- enhanced participatory rulemaking process on that in which
we held public workshops. We put out a proposed rule -- an early draft
of a proposed rule for public comment, and then went through the
rulemaking process so that in July of 1997 we issued a final rule on
decommissioning of lands and structures which now gives NRC licensees as
well as NRC clear direction on how to review decommissioning of lands
and structures, and it also gives the public clear information on how
NRC conducts its business with regard to decommissioning lands and
structures, and also what avenues are available to the public with
regard to being involved in an individual licensing situation or case
for decommissioning of a particular facility.
So the point being that this APA/EPR enhanced process was
conducted for the decommissioning process, and the process was completed
in 1997.
Moving on to the next slide, that was all background, we
finally now get to the four broad issues that we are going out to the
stakeholders with to get stakeholder views on. Again we want not only
stakeholder comments, but we're also asking for stakeholder information.
If people have some information about some of the things that are in
here, and we'll talk about them a little bit, that's part of what we're
going out to get also.
And again, as I noted earlier, this comment period on the
issues paper will be open through November. The paper we hope will be
in the Federal Register in a few weeks, after going through the, you
know, sending it to the Commission. If, again as I noted earlier, we
would probably come back to you and get your specific views on
particular issues, today our hope is that we can point out what we are
laying out there is what some of these issues and what some of the
questions that we're raising are, but after you have more time to digest
them, we could come back to you later this year in amongst the public
meetings and have another meeting.
Again, the structure of the issues paper is that it lays out
the issues, it lays out a couple of alternatives under each issue, and
then it asks several questions under each alternative or each issue
seeking advice or information or input from the stakeholders.
The first issue on this page, issue number 1, is the broad
question of whether we should even have a rule. There's some
question -- there are questions raised as to well, we don't want a rule
or, you know, why should there be a rule at all in this area. And so
the first issue, even though the Commission directed us to prepare a
rule, we thought it was important to address this issue by laying out
the pros and cons of whether we should continue with the current
case-by-case approach or conduct a rulemaking under the APA.
Moving on to the next issue which gets to needing a little
more detail. This is where we have the substitute page, I don't know if
everybody got it. Basically, all the substitute page does is it tries
to be less busy than the page that was in the stapled package. It is
the same information, it just cuts it in half, or puts one thing on each
page.
As you can see here, Issue Number 2 asks, what are the
principal alternatives for rulemaking that should be considered? It
lays out, again, as we did earlier in the background, three potential
alternatives, one being unrestricted use at different potential dose
levels, or above background, or even no dose above background. These
laying out of different alternative dose levels, including, basically, a
background level, is similar to the process that we did for the cleanup
rule, which we analyzed -- which we asked for public comment and also
analyzed in the Environmental Impact Statement, both a return to
background at the site, as well as different alternative dose levels
that a site could be released at.
We also list here the other alternative of releasing
material for unrestricted use or not permitting any release of solid
materials. And the third check is other as suggested by comments.
Actually, when they went out with an issues paper for the cleanup rule
back in 1992, one of the things that came back -- when they put out the
issues paper, there was not a restricted release option, so that is why
this other check here is important, because we may get some options,
suggestions made in public comments that would add to the list of
alternatives.
Going on to the next page, that gets into -- tries to get
into some of the details about what factors should NRC be using in
making its decisions between alternatives. The first being the human
health and environmental impacts. We talk about -- the paper talks
about looking at assessment of, obviously, impacts to individuals, but
also assessment of impacts to different population groups, and the paper
also talks about the fact that there can be competing impacts, so that
just by having a lower dose criterion, which obviously lowers -- a lower
dose criterion for cleared material, while that obviously lowers the
dose impact for exposure to that material, there could be a competing
impact, that because you have to -- now, all that material, rather than
going into clearance goes to, say, low level waste, the replacement of
that fresh material, or that material with new mined material would have
impacts associated with that.
So we had a similar -- I keep referring to the cleanup rule,
but we had a similar situation there. And so what we tried to do in the
Environmental Impact Statement was balance both impacts that went down
against impacts that go up. So that would be what we would be doing and
we would be asking -- the paper asks specifically, what are suggestions
for making this balance and what are some of the other impacts that are
competing, both radiological and non-radiological?
We also will be doing a cost benefit analysis using NUREG
BR-0058, which is the guidelines for -- NRC's guidelines for complying
with the Executive Order. We would be looking at all -- we would be
looking, as part of this balancing, we would be looking at the costs of
the whole process by which material would be cleared. We would be
looking at the cost of surveys at the different dose levels that you see
here. We would be looking at possible impacts, economic impacts on the
scrap metal industry. Is there a potential that we would -- that alarms
would be going off causing material to be rejected and sent back, and
what possible economic impacts are associated with that.
We would be looking at implementation considerations. Tony
will be getting into some of this in more detail in a few minutes. The
implementation considerations, of course, would include -- what are the
questions or concerns about surveying large quantities of metal at these
low dose levels, or even at dose levels near background or at
background?
As I just noted, some of the answers to these questions,
like on the implementation or the environmental impacts, we will be
developing in our work, but we are also asking the public to provide
input to help answer some of these questions. And we will be looking at
other international, national and state standards.
Going on to the next slide on Issues 3, we will be -- Issues
3 in the paper tries to flesh out a little bit more information, or a
little more detail about the potential for restricted use on releasing
metal. One option being we could release -- or, I'm sorry, we could
restrict the first use of solid materials to some authorized use,
particularly, as it notes here, you could perhaps make steel beams that
you would use in a structural support.
We were at a meeting a couple of months ago where a
gentleman suggested we could make military equipment. He was talking
about tank treads, so, you know, rather than consumer products. So that
can question can come up, or that is a potentially valid alternative
which we should consider.
A question that is associated with restricted use would be
that because of the uncertainties in controlling material flow or where
the material goes, we may need to require that the processing of the
material into this first use be licensed by the NRC. So a question that
is raised in the issues paper is, should NRC license the -- I guess, the
manufacturer, for example, of the bridge structure? And, so, that would
be -- that is a question that is raised.
There are several questions that are raised in the paper, I
could run down what they are, related to that, related to how long the
restrictions should stay in place, what are candidate materials. What
is a good set up for restricted use?
An interesting question in the cleanup rule which we just
issued, there is a restricted -- there is some parallelism, there is an
unrestricted and restricted use of buildings and lands in the cleanup
rule, and if there is restricted use, there is an opportunity for public
involvement in how these restrictions are set up. In the cleanup rule,
if you restrict use of a building or lands, you terminate the NRC
license because it was decided that the public deed process of how a
particular piece of land or building would be used can be satisfactorily
covered by the existing deed process, just the local land set up.
So, the cleanup rule for the lands and structures allows NRC
to terminate the NRC license when the dose level is reduced to a low
enough level and then the whole process of the restricted use, and the
deeds and the lands only being allowed to be used for, say, industrial
purposes, not a farmer, that is all an unlicensed use. Here, you may
have, because, like I say, there is no -- I don't know if there is a
deed process for tanks and pipes as they leave a reactor, so you may
have to license how this material is handled until it winds up in a safe
form. So that is the difference between the two rules.
Also, the cleanup rule had a public involvement process
where how these lands were used could be reviewed by the local populace
so they could provide input as to how these lands and structures were
used in a restricted way. Here, because you have metal that will come
out of the plant and go anywhere in the country, having a public
involvement process at a particular site maybe is different or may be
more difficult. So these are questions that are raised in the issues
paper.
The second alternative that we list here is that we would
restrict release of the metal to only a landfill site rather than
allowing any consumer or industrial use at all. The rationale for that
would be that this would cut out any direct public usage exposure
pathway and limit exposure pathways to only what you might get from any
landfill exposure, which is generally thought to be at least fairly well
-- it can be fairly well defined, unlike perhaps consumer uses, which
can be fairly broad.
So those are two restricted uses that we indicate as
potential alternatives.
Finally with regard to the issues that we list, issue number
four, which is on page 13, the Commission directed us in their SRM.
Their other point that they made was that the rulemaking should cover
all materials unless there was some factor that would cause us to limit
the number of materials covered, namely that it would delay -- if we
expedite the rulemaking to limit the materials covered in the scope, we
should do so.
Our technical basis that we have developed and which Tony
will get into a little bit is basically right now limit it to metals,
concrete, and to some extent soil, so one alternative is to limit the
rulemaking to a select group of materials, namely metals, concrete and
soil. Another alternative is to apply it to a wider group of materials,
as you can see here, and another alternative would be to conduct the
rulemaking on this wider group of materials at a later date and there
are specific questions on that in the issues paper.
The next page goes into the development of the technical
basis and I will let Tony proceed from here.
MR. HUFFERT: Thank you, Frank. I would like to point out
some of the requirements that the Staff were given from the Commission
in its June 30th, 1998 SRM on how to proceed with this rulemaking.
They told us to develop a dose-based regulation as compared
to a detectability based regulation, so we have been pursuing rulemaking
at different dose levels, as Frank mentioned, from basically background
up to 10 millirem with values in between.
They asked us to focus on clearance levels above background
for unrestricted use, which means do not include background doses or
background concentrations of radionuclide in this rulemaking when you
are doing your dose assessment, and they also asked us to consider
existing work being conducted by the IAEA, other contractor analyses
that have been performed, for example the Environmental Protection
Agency has been working in this area and has done a substantial amount
of work to date that we can draw upon.
Also, speaking of EPA, we have been directed to look into
NORM and NARM practices. Specifically they asked us to take a look at
the practice to take coal ash and recycle it into building materials.
We think that that would be a fairly interesting benchmark to consider
when we are developing our own analysis.
We have been asked to use realistic scenarios when we are
developing the rule as compared to using really conservative analyses,
and also to consider the materials that have been analyzed so far, which
is iron, steel, copper, aluminum, and to some extent soils.
On the next page I would like to talk briefly about some of
the work that has been conducted so far by the Office of Research. They
have been working for several years with other Federal agencies
developing a draft report, NUREG-1640. This document covers iron,
steel, aluminum, copper, and concrete.
The reason for these materials being selected was that
initial studies indicated that these materials would be of economic
value and that these would likely be released from not only the NRC
licensees but also DOE as well.
These materials have been studied by other Federal agencies
and we can draw upon that work also.
They took a look at 79 scenarios for clearance and they
specifically identified 85 nuclides to analyze. The 85 nuclides were
obtained from looking at manifests, Class A waste, and then comparing
that listing to work being done by the Environmental Protection Agency.
DR. GARRICK: Are you going to say something about the basis
of the scenarios?
MR. HUFFERT: I can, yes. Would you like for me to do that
at this time?
DR. GARRICK: Well, if you are going to later, that's fine.
MR. HUFFERT: Let me go to the next bullet and then I'll
talk about that.
We are planning on issuing this draft NUREG-1640 this month.
Currently there is a Federal Register notice being developed by the
Office of Research. We are hoping that we will have a fairly long
comment period on that report so that it will extend well into the time
that we have our public meetings, which will be running through the Fall
of this year.
About the scenarios, the 79 scenarios were arrived at
through trial and error basically. The Office of Research looked at
clearance, meaning there could be direct disposal of material, there can
be direct reuse of material, and there also can be recycle of material.
Recycle would involve materials being released from a nuclear facility
as scrap. It would then be handled at a scrap facility where it would
then get back into a steel mill where it would then be processed and
then put back into use.
DR. GARRICK: And that is what you mean by a scenario?
MR. HUFFERT: There are actually two different models that
were used to develop these scenarios. There's a material flow model in
NUREG-1640 which has different scenarios of how this material is
basically moving once it is released and there is also a dose assessment
model and the dose assessment model has scenarios in there. These are
basically exposure scenarios so the combination of those, it is my
understanding, represents the 79.
As far as the limiting scenarios, it turns out that consumer
products are not the limiting exposure pathway and in many cases it is
truckdrivers or it is workers at processing facilities. The workers at
processing facilities would be, for example, a worker in a steel mill
where the material can become airborne through different metallurgical
processes and the material can be potentially concentrated so these are
the sensitive scenarios that have led to the critical dose conversion
factors.
Further work is needed to develop our technical basis.
NUREG-1640 really was focused on identifying realistic critical groups
and calculating dose factors for each critical group. It did not get
into collective dose assessment. It did not get into soils. As Frank
mentioned, there has been some work done on soils for the
decommissioning rule, and we can benefit from some of that work already
done. But NUREG-1640 does not specifically address soils.
We will have to develop more scenarios for the noncritical
individual dose scenarios that are needed for estimating collective
doses in population groups. We think that we have to take a look at
population behavior. We have to take a look at the probability of a
number of persons being exposed to both processing and the end products
itself. NUREG-1640 does not cover that. So we are currently in the
state of we have developed a statement of work.
We are going to go out for competitive bid to a contractor
to further refine that work. And we're also going to be doing more work
in the area of cost-benefit analysis. The EPA has done work in this
regard. However, the NRC has not.
The third bullet on this page talks about some of the
progress made by the EPA in developing the technical basis. In 1997
they released two reports. One was a draft technical support document
entitled "Evaluation of the Potential for Recycling Scrap Metals from
Nuclear Facilities." This is basically a data compilation report that
discusses supporting analysis for a second document they prepared which
is called the preliminary cost-benefit analysis and radiation protection
standards for scrap metal. The NRC Office of Research has been working
closely with EPA on these documents and I think it's a very good
resource for us to use.
We will continue to develop our technical basis in order to
develop a generic environmental impact statement, a regulatory analysis
to analyze the different regulatory options, and, as Frank mentioned, we
have four statements of work that are being developed right now.
Two of them have to do with implementation. I'll be
intimately involved with those, as I'll be working on a draft regulatory
guide. We are planning on going to national labs for that support. We
will be focusing one contract on survey methodology, and we'll be
actually focusing another contract on the detection of radioactivity,
the actual radiation physics involved, since we are going down to such
low concentrations of radioactive material in matrices --
DR. GARRICK: Yes, at some point I'd like to hear you
comment a little bit about the problems that I can envision when you
start talking about complying with the one-millirem requirement, the
instability that -- the radiation instability that exists in some of
these sites. It sounds like that's a tough challenge.
MR. HUFFERT: We faced a similar technical challenge when we
were working on the decommissioning rule, and I was involved in that.
We were given a task to go from on the order of 30 millirem per year all
the way down to basically background. We contracted with some experts
in the field. We took a look at what was needed, and we actually came
up with new survey approaches that were incorporated into MARSSIM. And
that's been widely accepted.
I think that we're going to be facing a similar problem
here. The differences that the material that was analyzed for the
decommissioning rule was basically on lands and structures, and in this
case it's going to be incorporated in metal. And detecting alpha and
beta contamination when it's found in a matrix of steel is almost
impossible to do with the survey instruments. You might have to use
other methods, for example, taking samples in order to do that.
We don't have any answers for you today. This is under
development. We started working on this in October, and we are
currently in the stage of getting our contractors on board and looking
at this problem. I can tell you that the staff has been involved in
recent workshops in this area. I've attended a couple of them where
this was discussed. And there is a lot of work going on both nationally
and internationally in this area that we can draw upon.
MR. CARDILE: Also I think the two contractors that you're
planning on using are the ones that assisted you on the --
MR. HUFFERT: Yes. Well, we're hoping for that.
MR. CARDILE: Okay.
MR. HUFFERT: We're in the stages right now of trying to get
contractors on board, and the one in particular is extremely good at
radiation physics, and I think they would be invaluable to have on
board, because they could help us in that area.
The next slide was put together to present a snapshot of
where we are today in our technical basis development and the work ahead
of us in order to complete this rulemaking. On the left-hand side of
the table we have basically the NEPA analysis, which is referring to our
generic environmental impact statement that we'll be developing, the
regulatory analysis, the draft reg guide, and then public participation.
The middle column discusses the regulatory requirements or procedures
that we would be following in the development of our technical basis.
For example, under NEPA, we have fairly clear guidance on how we should
proceed in our own 10 CFR Part 51.
Under the regulatory analysis, as Frank mentioned before, we
have Executive Order 12866, an SRM, and also a brochure report on how to
conduct that. We just talked about the draft regulatory guide, how we
need to develop practicable instrumentation methods, and as far as the
public participation, we would be holding four public meetings during
this year throughout the country, and that will be satisfying two
requirements. It's not only going to be satisfying the 10 CFR 51
process but it will also be satisfying our own enhanced participatory
rulemaking process.
To the right we have the technical information needed, and
to give you a feeling of where we are today, we have items A through L
listed. We only have item A and item K at this point. Item A is
NUREG-1640, which talks about the individual dose factors for four
materials. We need to develop items B through G in order to do our EIS.
Items H and I are more involved in the costs. We need to find out more
information on the actual source inventory. That has not been well
defined. We need to find out economic impacts that will be given to
industry with this rulemaking.
And as far as the issues papers is concerned we're getting
that out for public comment next month, and I already discussed the
public workshops.
It's also important for you to understand what the staff is
involved in amongst other Federal agencies. I alluded to work with the
EPA, but we're also working with the Department of Energy and other
Federal agencies on the Interagency Steering Committee on Radiation
Standards.
We recently had a subcommittee meeting in February where we
talked about our rulemaking efforts and other work that's being done in
the Federal Government in this area. There is a Department of State
initiative called the International Radioactive Source Management
Initiative. It is something that is fairly recent in its development.
We have many different Federal agencies participating on that
initiative, private industry, we have the Conference of Radiation
Program Control Directors, and the focus is not only on clearance, but
it's on source tracking internationally.
The NMSS and research staff have also been participating
internationally with meetings at the IAEA, and we have one group of
people going from the EPA, NRC, and DOE over to Vienna next month to
work on one of the technical basis documents called Tech Doc 855. So
the staff is quite busy in this area.
That concludes my presentation.
DR. GARRICK: Further comments?
DR. WYMER: Yes. I am glad to see you working on this. I
think it is an extremely important issue and I think there are hundreds
of millions of dollars at stake here, depending on how this thing comes
out. I had one specific question. It seems to me, I am sure you have
good reasons, that you are limiting yourself quite a bit when you talk
only about ferrous metals, aluminum, copper and concrete. I suggest
that maybe you might want to consider the strategic and critical
materials list that the Department of Commerce puts out, since these are
strategic and critical materials, and they have a definite definition of
what those terms mean.
So it seems to me that this rule will be applied broadly
eventually. No matter how you initially decide you are going to direct
it, it will be applied as broadly as people choose to apply it. So I
have that one comment specifically.
MR. CARDILE: Yeah, I think -- and that is one of the
questions in the issues paper. It lays out the material or the
equipment and material we have information about now, the database we
have now, and then it requests, well, what other suggestions are there
for materials? And we would certainly take that under advisement.
DR. WYMER: Any other comments?
DR. HORNBERGER: Yes. Can you give me an idea -- you say
are going to develop a dose based regulation considering from background
up to 10 millirem. Why 10? Why not 100?
MR. CARDILE: I will start and then you can jump in.
MR. HUFFERT: Sure.
MR. CARDILE: Well, it lays those I guess three or four as
what we think are probably potential alternatives. The opening paper,
for the cleanup rule, started at 100 and suggested 100, 25, you know,
15, 10, 1 down to background, and we wound up having a dose standard of
25 millirem for the cleanup rule for a land and structure based on, to
some extent, on the fraction of 100 millirem as the appropriate value.
The initial thought in preparing this paper is that,
because, potentially, these materials can be more dispersed in the
public usage than perhaps one fixed decommissioning site, or
decommissioned site, that a value less than the 25 millirem from the
cleanup rule was probably more appropriate here.
Numbers that have been, you know, used or talked about in
international circles, for example, for clearance, have been the range
of 1 to 3 millirem, so at least as an opening suggestion here, we listed
10. Again, the question in the issues paper, are these appropriate
values or not?
DR. HORNBERGER: So sort of your rationale is that because
these would be sources that could move around, that they would somehow
be potentially more dangerous than a source that was fixed?
MR. CARDILE: Well, not more dangerous, but perhaps a person
could be exposed, whereas, a person would not likely be exposed -- well,
not more likely. The dose calculation coming up with the 25 millirem
for a decommissioned site is a person, a resident farmer or a resident
person living or working at that site. That is kind of the limit as to
what they would get. Whereas, here, it is not that it is more
dangerous, but there is potential for, I guess, more multiple exposures
in that --
DR. HORNBERGER: So it is a collective dose argument rather
than an individual dose?
MR. CARDILE: Well, it is also an individual dose argument
to an individual, if we have to watch that you don't get more than this
dose level from a particular -- that you can't get exposed to several
pieces of equipment, or former pieces of equipment --
DR. HORNBERGER: If steel goes into a car and you drive
around a car for your life, and that is worse than being a farmer living
at the site?
MR. CARDILE: No, but the steel could go into the car, and,
you know, the material building your house, and the material, you know,
in your car, your bed frame or whatever, things like that.
DR. HORNBERGER: Has anyone worked out the probabilities
that those multiple things would happen?
MR. HUFFERT: Actually, that is one of the things that is
going to be looked at in our statement of work for the continuation of
the NUREG-1640 work. We are looking at exposures to multiple sources
and population behaviors. That has not been done so far, and it is
going to be a large piece of work to get that accomplished.
DR. GARRICK: Have you done the cost -- implementation cost
studies as a function of different standards, different clearances?
MR. HUFFERT: We will be working on that. How we did it for
the decommissioning rule was we chose different dose levels and we then
took the dose levels, converted it to picocuries per gram by using a
dose conversion factor, and once we had these levels of radioactive
contamination present, we then did studies to figure out what is the
cost of surveying to different dose levels. We would just take
different concentration values. We set up studies where we would use
very crude instrumentation, all the way to extremely sophisticated
methods that are almost impracticable to use to try to figure out where
the state of the art was.
And from there, we basically came up with cost curves, and
we could see where certain radionuclides were very difficult to measure
and it helped us in our generic Environmental Impact Statement. And a
similar thing would be done here for this rulemaking. The statement of
work that I have been working on with the Office of Research has that
stipulated, that we would go from a return to background or background
level, all the way up to 10 millirem or more. We think we have a handle
on what the dose conversion factors are from NUREG-1640 and other work
done by the federal agencies, so we can start applying that work -- I'm
sorry, those dose conversion factors to our study.
DR. GARRICK: What about pilot applications as a rule, is
this planned?
MR. HUFFERT: As far as implementation?
DR. GARRICK: Yes.
MR. HUFFERT: That is in the statement of work.
DR. GARRICK: Yes.
MR. HUFFERT: Not to sound like a broken record here, but
when we did this work for the decommissioning rule, we did pilot studies
at large decommissioning sites. We also set up a maze, if you want to
call it, at one of the national labs, work surveyors were required to go
in and survey against walls to find out how well they could detect
different radioactivity levels, and that also helped us as a pilot to
understand what -- how implementable our rule really was. And we are
planning something similar to that here.
DR. GARRICK: What have been the operators' reactions to the
program you have made so far, the people that have the facilities?
MR. HUFFERT: I haven't talked to anyone yet about that. I
have talked to people in the Office of Nuclear Reactor Regulation about
it, since they are the group regulating the reactors and they are on the
working group, they are on the steering group, they haven't raised any
concerns yet.
We don't know where the dose standard is yet, it is an open
book right now. If it is a higher level, it probably will not present a
problem. If it is much lower, it would be more difficult to implement.
DR. WYMER: How much attention are you paying to the
international standards in this area? They have already gone through
this, at least some of the countries, and they have established
standards, and they have methodologies established. How much are you
taking that into account?
MR. HUFFERT: The Office of Research -- in fact the
technical manager for NUREG-1640 is a member of the working group who's
developing Tech Doc 855. He'll be going there next month to refine that
document further. He has been a very good resource for the agency, and
we are kept aware of what's going on through him, and also our Office of
International Programs.
As far as implementation is concerned, I can talk to that a
little bit, if that would help. There are studies going on
internationally in this area not specifically related to clearance, but
illicit trafficking, and for example there's a study being conducted
right now at the IAEA that is -- they have set up a portable monitor at
one of the -- I think at the Austrian borders. They are evaluating
instruments from France, Germany, the United States, England, I think
Sweden. They're evaluating the ability of these equipments to detect
radioactivity in scrap or some type of confined geometry. There will be
a workshop next month at Los Alamos on this, and I can tell you I just
recently participated in a workshop with the steel industry on detection
of radioactivity in scrap which will actually be very close linked to
what we're doing here.
DR. WYMER: Fine. Thanks.
DR. GARRICK: I take it that this is a status report, that
you're not looking for anything specifically from us except the
discussion.
MR. CARDILE: That's right, and as I pointed out, a good
time to -- we'd be interested in -- the point of the issues paper and
the public meeting is to get feedback to feed into some of these
contracts as we go forward. And we'll be reporting back to the
Commission in hopefully February of next year based on the results of
all of these public meetings. So a good time to get some strong
feedback would be in amongst the public meetings that we're holding in
the fall, either while we -- or, you know, during that period of time or
maybe immediately after that time we'll probably be in a position to
report back some preliminary results about the meetings and also receive
your input.
DR. GARRICK: I guess that the real key here is that not as
what you end up with is the actual clearance limits, clearance level.
Is that right? And so the process by which you get to those levels.
And you say that those have not really been established yet.
MR. CARDILE: The clearance levels?
DR. GARRICK: Yes.
MR. HUFFERT: No, not at all.
MR. CARDILE: Well, I'm sorry, yes, the process for us doing
this rulemaking has been laid out, and it's laid out in management
directives, in our regulations, et cetera. But as far as what the
actual value is going to be, no, we don't have -- we don't know if it's
going to be 10 or 100 millirem or zero.
DR. GARRICK: Now are you satisfied that the way you're
proceeding that everybody that has involvement in this process, the
stakeholders, the public, et cetera, are in a position to contribute
information for you to make -- for that decision to be made?
I'm always thinking a little bit about the smaller operators
who don't always have the resources to handle these kind of projects.
MR. HUFFERT: I can tell you that when we do an analysis
we're required in our regulations to look at the economic impact of a
proposed rule on small entities under the Regulatory Flexibility Act, we
need to do that.
DR. GARRICK: Um-hum.
MR. HUFFERT: And as Frank had mentioned, we are actively
involved with the States in our working group and steering group, and
certainly the public meetings, the Federal Register notices, we're going
to have a Web site set up for comments on this. We're asking for a lot
of public participation.
MR. CARDILE: I expect that one of the participants in the
public meetings will be, for example, the scrap dealers or the steel
manufacturers, and they'll come back to us with a lot of information
about what's practical and not practical, what impact this could have on
their industry and not.
With regard to -- that will represent both the large and
small people who will be receiving this material. In terms of the large
and small NRC licensees, that'll be -- I presume that'll be part of what
we're getting at with some of these contracts that you do on survey
abilities and capabilities and what are the costs to survey material,
whether it's a reactor licensee or a small hospital. So --
DR. GARRICK: What do you consider to be the most difficult
technical issue? Is it the surveying part of the problem? When you're
dealing with these low levels?
MR. HUFFERT: I think it's going to be a tremendous
technical challenge if we are required to go to zero.
[Laughter.]
I don't mean to be facetious, but if you're at 10 millirem
per year, it's a much easier target, but if you're at a small fraction
of 1, it could be very difficult now. Maybe we can come up with some
innovative methods of surveying. I don't know yet.
DR. WYMER: In inferred, perhaps wrongly, from something
that was said, that maybe you'll be making these permissible doses on
these various kinds of materials radioisotope-specific with respect to
the contaminant, and in particular with respect to the half-life of the
contaminant, since obviously if it's a short half-life, it's not so
important that it have a low a dose, because after a little while you
won't have so much.
Is that in there, or did I read something more into it than
you said?
MR. HUFFERT: Go ahead.
MR. CARDILE: I'm going to let you answer. I was just going
to say one point I may have made which may have been confusing was that,
for example, a restricted use might be something that's beneficial where
a half-life -- an isotope had a short half-life because obviously it
goes away.
I don't think we're planning on setting a dose limit based
on --
DR. WYMER: On specific --
MR. CARDILE: Specific isotope.
DR. FAIRHURST: How will you know where to look for this? I
mean, there's certain pathways you can follow, you know, where something
started out, but you're talking about scrap yards and things like this.
How would you -- were you going to have a blanket requirement on all
scrap dealers that they must check? Or am I --
MR. CARDILE: Are you talking about in general or about this
restricted use possibility?
MR. HUFFERT: The surveys would be conducted at the point of
release of the nuclear facility.
DR. FAIRHURST: Okay.
MR. HUFFERT: I think before the material was released from
the nuclear facility, you'd have to survey it, assay it, whatever,
before it gets out --
DR. FAIRHURST: All right.
MR. HUFFERT: To the general public.
MR. CARDILE: But once it was released -- once it was
surveyed at that point and released for unrestricted use --
DR. FAIRHURST: Then you don't worry about it.
MR. CARDILE: It can go anywhere, and the hope is that these
dose models that have been done in NUREG-1640 would sufficiently
represent these pathways.
DR. FAIRHURST: There's no need for concern?
MR. CARDILE: Yes.
DR. FAIRHURST: I don't --
MR. CARDILE: And that's why the restricted use is in --
because it says that while if it's decided that -- to limit where this
material can go, then you have questions of well, how do you do that?
And it's something we'll have to face.
DR. FAIRHURST: Is this an issue that when you're talking
about public meetings that there will be a broad spectrum of public
involved or just people who feel like have some sort of business or -- a
business reason for --
MR. CARDILE: Well, I think, as I was saying, there would be
the nuclear industry or the licensed industry, not just sometimes when
we talk about nuclear we think about, you know, power reactors, but it
would be the whole licensed community. I mean, people from small walks
of life with regard to licensees.
It would also be the people who then receive the material,
they have a business interest, but they also have a from what we've
heard somewhat they also have an interest in terms of we're a steel
manufacturer or where a scrap dealer, and we either can or can't deal
with this material. So there would be that spectrum of people.
But then there would also be -- and I think that's the
process of the facilitator is to go get other, you know, public groups
to say we're concerned or not concerned about this material coming into
general commerce or general public consumer use, and if it does, what
are the dose levels and that type of thing. So the hope is that the
facilitator sets up these meetings so we get kind of people along this
step of this process of where this material could wind up.
MR. LARSON: Is your question in some of the past
participatory rulemakings, you know, the agency has provided funds to
some people that are unable to get to the thing otherwise. Are there
plans in this one to do that?
Is that what you're asking, Charlie? Like the Native
Americans --
DR. FAIRHURST: What I'm trying to say well, if you have to
go down to one millirem, or .1, it would seem to me that you're going to
have a lot of pressure in any public meeting to keep going lower and
lower and lower, and at some point you have to say look, this doesn't
make either risk sense or financial sense or whatever. I don't know. I
just --
MR. CARDILE: Well, one of the things that -- well, one of
the things that the issues paper points out that the public meetings are
intended to foster discussion, obtain advice, obtain data or
information, perhaps not to reach -- and point out things like competing
impacts, point out things like implementation problems like going to
zero, but not necessarily to reach consensus. So --
MR. HUFFERT: That analysis will be performed in our generic
environmental impact statement and regulatory analysis. There's a
process set up for weighing the different factors.
MR. LARSON: If a clearance level is for unrestricted use,
then why are you going to go through a collective dose analysis, which
sort of amplifies the situation that -- I don't understand.
MR. CARDILE: I can start. Again, for example, these
cleanup rules, for example, we went through a process of saying all
right, well here's the exposure to an individual, but, you know, on the
other hand, especially in the case of clearance, you might, while the
exposure to an individual may be low, the exposure to a large number of
people because there's a lot of equipment available could be higher.
The guidelines of NUREG or BRO-058 in complying with the
cost-benefit regulatory analysis guidelines talk about balancing costs
and impacts. So we'll be looking at both individual dose and collective
doses.
DR. GARRICK: That likely introduces -- doesn't that
introduce a real complication as far as accountability is concerned?
MR. HUFFERT: What do you mean by accountability? Do you
mean as far as defining the population?
DR. GARRICK: Yes.
MR. HUFFERT: Yes. I think that what would happen is we
would have to give it our best shot of not only understanding population
behavior, but also try to estimate the uncertainty in those numbers.
And when we are collective doses, I think we should be checking the
uncertainty in those numbers carefully. And if we follow NCRP 121 we
would be categorizing our uncertainty estimates for the collective dose.
MR. CARDILE: An additional uncertainty in trying to
estimate collective doses is, if you are just calculating individual
dose, you just need to know if such-and-such concentration gives you
such-and-such individual dose. In order to calculate collective dose,
we have to go back and make some estimate as what is the volume of metal
at a power plant available at these levels. And that is something that
is going to be part of these contracts, but it is not easy to put a
handle on.
DR. GARRICK: It sounds like a nightmare to me. Doesn't
this run the potential of forcing you into the equivalent on an
individual dose that is --
DR. HORNBERGER: Minuscule.
DR. GARRICK: -- minuscule and infinitesimally small? Isn't
there an allocation problem here of great proportion?
MR. CARDILE: Well, an experience we had in -- I keep
referring to the cleanup rule, but an experience we had in the cleanup
rule was that we tried to do the same thing. We looked at, what is the
collective dose from people either coming on and using these structures
or lands for different possible uses down the road? That was a little
easier because there is perhaps a limited number of ways you can use a
building. But we actually looked at the building and said, all right,
this building could be used for a certain type of usage, and the lands,
or it could be used for an apartment building, you know, where there is
a lot of people, but a lower dose because you only -- you know, there is
a limited number -- a limited amount of usage of the land, as compared
to, say, a resident farmer who is growing the crops.
So we tried to look at alternate collective doses, and we
had several different alternatives. And what we -- if you go back to
the statement of considerations for the final cleanup rule or
decommissioning rule, we, in essence, said that, look, there is not an
absolute -- I forget the word we used, but there is not an absolute,
definitive answer with regard to where the best ALARA number or the best
cost benefit number is. It can vary, you know, based on the
circumstance, based on uncertainty.
The cleanup rule wound up saying we think that 25 millirem
is the right fraction of 100 millirem. We think that this is
sufficiently supported by the regulatory an and collective dose analysis
that we think this is the appropriate number. So that is a long way
around answering your question that, you know, in that case, we
basically looked at the individual dose and said we think this is the
appropriate number. We looked at the regulatory analysis and balancing
of collective doses and benefits, or costs and that said that, you know,
we can't make the decision based on that.
We think we are right here with the right number. The same
thing could happen here. We could decide upon an individual dose that
we think is an appropriate constraint below 100 millirem, an appropriate
fraction of 100 millirem. We could look at the collective -- we could
say that implementation-wise, you know, you can measure this in a
reasonable way. And with regard to the collective dose, given all the
uncertainties of quantity of metal, following people around, how they
might use this material, that, you know, that we think whatever this
individual dose value we have set is reasonable. So that's two years
ahead of where we are right now, but --
DR. GARRICK: It seems that we work very hard to make this
as complicated as it can be.
MR. CARDILE: Well, of course, we are required, as Tony's
slide points out, to do a NEPA analysis, to do a regulatory analysis
using the guidelines of the NUREGs.
MS. THOMAS: Wait, wait. If you are not going to account
for the material once it gets released for unrestricted use, how are you
going to determine collective dose? That just doesn't -- it doesn't
follow.
MR. CARDILE: Well, we are going --
MR. GNUGNOLI: I think you have it just backwards. What we
have to do is decide what criterion we will use. In order to see the
cost benefit of using the different criteria to set clearance, we have
to sort of know what the cost is going to be, both in terms of health
effects and in terms of the commercial impacts and such. And, so, sort
of the other way in that. Once we have set the clearance criterion and
everybody accepts it, who cares what happens with all that?
You know, at this point we are taking the lead from other
organizations who have gone a little bit ahead of us, like IAEA, where
they have tied it traditionally to the idea of trivial dose, which is
the 1 to 10 millirem range from Safety Series 89. And that is basically
why it factored into our range of numbers that we selected for the dose
considerations.
And then other people will say the difference between 10
millirem and 30 millirem is really inconsequential. So the idea is
perhaps in that range, we will cover enough that it might be below,
let's say, the D and D standard of 25, that we have, in effect, tried to
cover the spectrum a little bit at the lower end.
DR. GARRICK: So given what we have heard from the health
physics experts about the effectiveness of 100 millirem standard as
assuring the protection of the public, given that kind of information,
what is your view with respect to risk and safety if we eliminated the
collective dose requirement in the rule?
MR. CARDILE: We are not anticipating having a collective
dose requirement in the rule, of course. I mean we are only using it as
a tool. The rule would be --
DR. GARRICK: Well, to calculate the dose. Yes.
DR. FAIRHURST: What is the basis for the IAEA 1 to 10 as
being trivial, is that --
MR. GNUGNOLI: It is out of Safety Series 89. They went
into it to some degree -- there is a discussion in Safety Series 89 on
setting that.
DR. FAIRHURST: No, but I mean was that based on sort of
idea that a collective dose, no matter whatever material it was, you
could never do any harm with 10 millirem?
MR. GNUGNOLI: I really don't remember.
DR. FAIRHURST: Or did you just pluck it out of the air?
MR. GNUGNOLI: Actually, it would have been a number of
experts plucking it out of the air, that's the way they work.
DR. FAIRHURST: I think most people would agree that 10 is
trivial.
MR. GNUGNOLI: Right.
DR. FAIRHURST: That doesn't mean that 10 is a justifiable
number.
MR. GNUGNOLI: Well, the idea -- I don't doubt that there
are practices and activities with higher possible dose levels that would
be okay. The idea over this triviality aspect is it would be applied
across the board to any activities so you wouldn't have to think about
it.
DR. FAIRHURST: Right. I understand.
MR. GNUGNOLI: But in things above those levels, it may
still be perfectly safe, but they would have to be looked at
site-specifically.
DR. FAIRHURST: It is like shooting yourself in the foot.
MR. GNUGNOLI: Yes.
DR. GARRICK: One of the things that I think that is a
hopeful advantage of a risk-informed approach to regulatory practice is
simplification, is, you know, the idea of getting away from subsystems
requirements over prescriptive, intermediate results, et cetera. So
that is an aspect that we are looking for.
One of the things I was curious about here is, given that
you have guidance from the commission level with respect to regulations
and the development of new regulations to adopt a risk-informed,
performance-based perspective, what have you done here to do that? As
best I can tell, the only thing you have done is the so-called
probabilistic exposure scenarios. Is that it?
MR. CARDILE: I guess -- don't forget, we are at the very
early stages.
DR. GARRICK: Yes.
MR. CARDILE: As Tony mentioned, we are planning on making
sure that this thing is implementable, any dose level we pick is
implementable. The other thing is we are looking at what is the
appropriate individual dose level, what is the appropriate risk that we
are looking at here. So, I think, you know, obviously, this rule is
going to be based on both the risk to an individual and the ability --
the capability to implement whatever rulemaking we come up with.
DR. WYMER: I have a --
MR. CARDILE: But we may be -- I'm sorry, I didn't mean to
cut you off.
DR. WYMER: Go ahead.
MR. CARDILE: I was just going to say that that is the idea,
the point of the issues paper is to say, is this the appropriate set of
factors to be using in the consideration of setting the standard?
DR. GARRICK: Yes.
MR. CARDILE: I mean here is alternative dose standards
which we could use, here are some of the factors that we would consider
in developing them, namely, health and environmental impacts, cost
benefit implementation, other countries' standards. What guidelines
would you give, you know, the collective you, as we proceed?
The point of the issues paper is to foster this kind of
discussion, but we don't have the answers to these questions. We're
trying to formulate what our questions that we can go to the public with
and -- both the general public and the regulated public and the steel
manufacturer public would, you know, wherever they fit in the spectrum
and talk about these kinds of questions.
DR. GARRICK: Yes. Well, we sort of believe, I think, as a
committee, that the strategy with respect to regulatory development, if
indeed you're going to go in the direction of risk-informed
performance-based, is to make them very tough with respect to
performance and risk requirements, but allow a lot of flexibility with
respect to how you get there, and move away from overprescriptiveness of
the intermediate steps. And I take it that's what you're trying to do
with a dose-based approach.
MR. CARDILE: Definitely. I think, for example, if you go
back to the cleanup rule, it's fairly unprescriptive in the sense that
it lists a dose standard.
DR. GARRICK: Right.
MR. CARDILE: And that's basically it.
DR. GARRICK: But I'm a little worried about this issue of
what you end up with as dose levels, number 1, and how that is
allocated, number 2.
MR. LARSON: Are you alluding then that you'd like to see
the issues paper and the technical basis document rather than towards
October and November, sooner than that? Because supposedly a technical
basis doc can be out -- you're saying June, right? And of course the
SECY says the issues paper was out in January, but it still hasn't got
out yet.
MR. CARDILE: No, the issues paper said that it would be
sent to the Commission in March, and that's what we're planning on
doing, and then we will publish it in April for comment until November.
The NUREG-1640 is scheduled for publication in March.
DR. WYMER: Yes, that sort of gets at what is the extent of
the responsibility of the Nuclear Regulatory Commission in these kinds
of matters. In a way it gets at that. It also relates in a way to two
points I raised earlier on strategic and critical materials and whether
or not you're radioisotope-specific in this thing.
Although I kind of inverted the last one now, and I'll say
what materials are you going to pay particular attention to, if any, and
let me tell you what I mean when I ask that. I'll give you a trivial
example, but there probably are better examples.
I know, for example, that there was a great deal of concern
in the people doing very-low-level background counting that we don't
crud up the copper that's used in the instrumentation, and there are
probably other similar examples that can be found in specialty uses of
materials that might be contaminated with low levels of radioactivity
that would be deleterious to scientific investigations or health studies
or things like this.
So are you going to try to pick out, you probably are not,
but pick out specific materials that have known specific sensitive uses,
uses that are sensitive to radioactive contamination and put them into a
special class with special requirements?
MR. HUFFERT: No, not to my knowledge.
DR. WYMER: The answer is no, huh?
MR. HUFFERT: So far what we're doing --
DR. GARRICK: Simple answer to a long question.
DR. WYMER: Yes.
MR. HUFFERT: We are focusing on copper, aluminum, iron,
concrete. That's what was done. We will be including soils at the
Commission direction. And for this proposed rulemaking, I don't think
we're going to be including any more materials unless we're directed
otherwise. It's one of the issues that are contained in the issues
paper, should we be doing this. So --
DR. WYMER: Copper of course is one of the --
MR. HUFFERT: Right.
DR. WYMER: Sensitive materials.
DR. GARRICK: I guess one of the things that would help the
committee a great deal on this whole issue is to get a better sense of
the world into which this thing is going to be applied, because it would
be easier for us to visualize what kind of problems might develop if we
better understood the variety and spectrum of applications in the kinds
of facilities you're talking about and the size, shape, et cetera.
I'm sure we can dig that out, but I think that it's
important to understand the operational implications when you're looking
at any kind of future development of regulations.
That's why we ask the questions about participation, who
participated in developing source material that you use to move forward
with the documentation.
I don't know whether it's practical for us to at some point
in time get a little better overview of how this thing is going to be
used or not, Howard.
DR. GARRICK: I think -- part of my concern about a lot of
these things is I think we sometimes -- the committees are handicapped
unless they're really operationally involved and can get overacademic
about their consideration of some of these things, and I think we need
to be a little educated on the field and what's going on out there in
order to better visualize some of the problems that you might run into.
I don't know if that makes any sense to any of my colleagues
or not.
DR. WYMER: I don't mind being called academic.
DR. HORNBERGER: Howard can brief us.
MR. GNUGNOLI: One of the things that really wasn't
discussed a whole lot is the fact that the United States may be faced in
the future with importation of materials, and there's very close work
with the State Department on that. There's -- we are aware that perhaps
the extent that you are addressing can be described as pervasive. It's
almost in every --
DR. GARRICK: Yes.
MR. GNUGNOLI: You know, aspect of our society, and maybe
we're putting too much stock in this enhanced participatory rulemaking
process. But it is our hope that we will glean more and more of a
picture as time goes on with people telling us you don't have the idea
of what's going on, what about this and this and this?
DR. GARRICK: Yes, one of the bodies that I like to hear
from of course are the people that are going to be affected by this.
MR. GNUGNOLI: Did you say infected?
DR. GARRICK: Affected, and particularly because the
standards seem to be very, very low that we're talking about, and it's
not clear that there's much anxiety here as far as health and safety is
concerned. But I think the view of the licensees that have to live
under these rules is very important for us to also hear.
Because they can speak the kinds of problems that I am
alluding to with direct experience, and that as background information
has always been very helpful, to me, anyhow, in offering any kind of
advice on these kind of issues.
MR. CARDILE: I am sure that with regard to the licensees
who are going to have to face these dose levels, that they will be well
represented at these public meetings.
DR. GARRICK: yes.
MR. CARDILE: And also from the experience of the cleanup
rule, I am sure we will get plenty of letters or comments.
DR. GARRICK: Yes.
MR. CARDILE: Written comments on whatever stage we are in,
including I am sure when the issues paper goes on the streets, we will
get some written reaction from the nuclear industry, the NEI, you know,
the various industries saying we have no material, this is a waste of
time. These doses you are talking about are too low.
We got -- you know, like I say, the cleanup rule, steps
along the way generated quite a bit of information, you know, written
letters to us letting us know what is reasonable, what is not
reasonable. So that aspect, I have no -- that piece of the world, I
have no doubt, will let us know what is going on.
I also have no doubt that the steel, given what we have
heard at a couple of meetings, that people who are going to be the
immediate recipients of this material will let us know that these doses
are too high or too low, or are going to cause havoc in their industry
or not.
And then I have no doubt that, you know, at least convening
the process to get public involvement, you know, the general public,
they will let us know whether they think these doses are too high or too
low. That was certainly our experience in the cleanup rule, and I
expect that this facilitator for this rule, both the internal -- well, I
can't speak to the external facilitator, but the internal facilitator
for the cleanup rule is the same person who worked on the -- for this
rule is the same one who worked on the cleanup rule and is familiar with
the parties and how to get representation of the different parties and
how to bring that, you know, their views forward, so we should be pretty
well served.
In terms of looking at trying to give you better information
about what is the universe of materials out there, and the situation out
there, there was -- an earlier draft of this NUREG-1640 had a discussion
of a literature survey of materials that were covered, you know, that
would be covered by something like this. I don't know if that was ever
published, but I would suspect in succeeding documents that we are going
to have that type of information available to you.
DR. GARRICK: Okay. Any other comments from members, staff?
[No response.]
DR. GARRICK: We are grateful to your time management in
allowing us plenty of time to ask the questions that we wanted, so we
like that. Thank you very much. I think that completes this topic.
MR. HUFFERT: Okay. Thank you.
MR. CARDILE: Thank you.
DR. GARRICK: Thank you. Okay. What I would like to do is
maybe, given it is a long afternoon, is take -- rather than one 15
minute break, we may take two 10 minute breaks, and I would like to
declare one right now, a 10 minute break.
[Recess.]
DR. GARRICK: We will come to order. We are now going to
hear from Nick Orlando on the decommissioning standard review plan.
MR. ORLANDO: Thank you, Dr. Garrick. What I would like to
talk about today is just to give you all a little update on the standard
review plan. I think the first time I talked to you about this was
about six months ago, and in that discussion I showed you a schedule
where we had incorporated some ACNW briefings and some requests for
input, and this is actually the briefing or request for input that I was
supposed to have for you a couple of months ago, but we have supplanted
that with just an overall program presentation, so that is what I am
here to talk to you about today.
Just to give you a little bit of background information,
remind everybody, back in July of '98, the commission gave the staff
some direction to go forward with some guidance that the staff had put
out, specifically the DG-4006, said send that out for a two-year comment
period and maintain a dialogue with the public during the comment
period, develop a standard review plan that incorporates the
risk-informed iterative approach in NUREG-1549, and also provide clear
guidance on what we mean by ALARA when we develop the SRP, review the
potential conservatism in the D and D screening code, and test the D and
D model on some sites and use that as a test bed for developing your
standard review plan, and, finally, use the probabilistic approach in
calculating the total effective dose equivalent to the average member of
the critical group, which is the dose target in the new license
termination rule.
My little portion of that world is the development of the
standard review plan. The purpose of the SRP is to allow the staff to
evaluate information that is submitted by licensees, to support the
decommissioning of their facilities. We want to be able to do this in a
timely and efficient manner. We have had concerns from licensees that
our reviews take too long and that they tend to be disjointed.
We also have to make sure that the decommissioning can be
conducted in accordance with all of our criteria and at the end of the
day, the licensee will have submitted all the information the staff
needs in order to make the judgments about the standard review plan.
We had given you a description of the contents of the
standard review plan. If you are familiar with NUREG-1199, where it
talks about -- or where it sets out acceptance criteria, and resources,
and analysis requirements and whatnot, the standard review plan will
follow that same basic format and content.
And then the very last bullet on the slide indicates that we
will use this to review not only decommissioning plans but also other
information. One of the things that has come up since we started
developing this, at least from my perspective is the interplay of this
with the activities in the Office of Nuclear Reactor Regulation. And I
think because of the process we have been going through, and because of
the discussions we have been having, that, at least for me, has gelled
up very nicely and we can talk about that a little later on when I get
to the question and answer period, so I will give you one question you
can ask me.
Okay. One of the things that the commission said to do is
make sure that we continue having stakeholder input, and to do that the
staff has and will continue to have a series of workshops on different
aspects of the standard review plan. Now, we had the first workshop
back in December, the 1st and 2nd, of last year, and in that workshop,
we discussed specifically dose modeling.
We had a second workshop in January and we talked about dose
modeling and restricted use scenarios -- or license termination under
restricted use. I recognize that these workshops are intended to
facilitate a two-way dialogue between the NRC staff and licensees. They
can raise issues to us, we can talk about them in an atmosphere of
trying to figure out what the questions and the possible solutions are.
We can't go to the licensees or to the participants in the workshops and
ask them for solutions because we run afoul of FACA if we do that, the
Federal Advisory Committee Act.
So, in some of the workshops we have had a lot of data
presentations. The last one, in particular, was extremely
symposia-like, but everybody seemed to enjoy that. We talked a lot
about some of the issues facing the dose modeling group. The last
workshop in March was actually on dose modeling the first day and ALARA
issues the second. The way we have set it up, at least the last three,
one day was dose modeling and then the other day was another issue.
In June we are going to have this third -- or the fourth
workshop, and if you look at your old schedule, that was actually slated
for I think the 18th and 19th. We got bumped because of the annual NRC
awards ceremony, the Presidential awards, and so we had to move that
back to the 23rd and 24th. And in that workshop, we are linking that to
a workshop that Tom Nicholson and Research is having on groundwater, so
there will be four days of groundwater modeling issues being discussed.
The August workshop, we are going to talk about comments
that we have received to date on the D and D screen, and either discuss
surveys or discuss questions or issues that are identified by the
agreement states. One of the persons who is -- or one of the
participants in the workshop has been Dave Zamori from the New Jersey
Department of Environmental Protection. He is representing the Council
of Radiation Control Program Directors, and he has requested a day for
the states to come in and present what they think the issues are and
questions and problems they see having. So I am not sure if we are
going to do that in August or October. Originally, we thought we would
do it in October, but the agreement states are kind of indicating they
would like to do it earlier as opposed to later. And then if we don't
do agreement state issues in October, we will do surveys.
Now, as far as some of the milestones --
DR. GARRICK: Are you going to tell us a little bit about
what you have learned from the workshops?
MR. ORLANDO: Well, one of the other handouts I gave you was
a list of issues that had been identified. Some of those are issues
that came out of the workshops. Some of those are staff generated
issues. I can discuss a little bit about some of the observations I
think that we saw in the workshops.
DR. GARRICK: I am especially interested in anything that
led to changes or revisions or anything that was significant enough that
it changed your way of doing business.
MR. ORLANDO: Okay. And to remind you, the milestones that
we have established or set up so far, we are still on track pretty much.
We have established the work groups. We have developed the default
tables and published that in November of '98. And we have identified
the issues needed to comply -- or to start developing the draft SRP
modules.
We still hope to finish development of the drafts by June
and then close -- and then revise those by May of next year, and then
submit the final draft SRP for review in the summer of 2000.
We have had several challenges, as you may or may not be
aware. Specifically, we lost some folks, Dave Fauver has moved on to
private industry. He was one of the group leaders for the surveys
module. He was also heavily involved in the dose modeling group. To
offset that, we have contracted with the Oak Ridge Institute for Science
and Education to help us develop the surveys component. In addition,
Tim Harris is going to be working with the dose modeling group -- Tim
Harris is in my section -- is going to be working with the dose modeling
group to take up some of the work that Dave had been doing.
Richard Tretill, who was originally slated to head up the
group on financial assurance has rotated out, and I am not sure when he
is going to come back, so we have asked ICF, Kaiser, who does a lot of
our decommissioning, financial assurance reviews, to come in and write
that portion of the standard review plan. It will be written by those
folks but overseen by NRC folks.
In addition, there have been some other staff moving around
a little bit, but we think we can still catch up and get done what we
need to get done.
The -- let's see, I seem to have lost my issues one. The
very last slide in your packet is a list of issues requiring resolution.
Instead of taking all of the issues on the second handout and trying to
make slides on them, what I thought I would do would be to give you
those, let you look at them at your leisure. You can think about them.
We can discuss a little bit some of the thoughts that I am having, or
that some of the work groups are having.
Bobby Eid is in the back -- or on the side. He can talk
about some of the issues associated with dose modeling. I can talk
about restricted use and some of the other modules. And, you know, we
can talk about that a little bit if you would like, or we can just talk
about the workshops, as you have indicated, or just about anything else.
I just wanted to give you an update as to where we were with everything.
We have met the milestone of identifying the issues and one
of the things we said we were going to do when we did that was give them
to you and let you all think about them, too. So that, believe it or
not, concludes my formal presentation and maybe you will thank me, too,
for giving you all kinds of time to ask questions now, till 5:30.
MR. LARSON: You have prepared some answers that you have
given in some of these public workshops to some of the questions on
these issues.
MR. ORLANDO: We have thought about some of the answers,
yes.
MR. LARSON: Well, I have been at some of them, and so has
Dr. Wymer, where you have talked about -- you have given the questions
in writing and given the answers orally.
MR. ORLANDO: Verbally.
MR. LARSON: But I mean you have got answers to some of
these.
MR. ORLANDO: Yes.
MR. LARSON: So if the members had some questions, they
could ask.
MR. ORLANDO: Certainly. But, of course, you know, those
are, as I said in those venues, those haven't been translated into
actual draft standard review plan acceptance criteria or anything yet,
they are just sort of the staff's working thoughts on a lot of them.
DR. HORNBERGER: Which do you consider the most sticky
wickets on this list of issues that is behind you?
MR. ORLANDO: Dose modeling.
DR. HORNBERGER: Dose modeling?
MR. ORLANDO: Without a doubt. The most work, the most
technical issues. Quite frankly, for health and safety plan surveys and
financial assurance, I think, in general, those are going to be pretty
easy to do. I mean it is just the process of writing down what we want.
It is kind of interesting, for health and safety plans,
there is guidance out there on what we want.
There's a lot of health and safety plans that have been
written. There are some very good health and safety plans. Financial
assurance -- there's just so many things that we're going to accept:
surety bonds, statements of intent by federal facilities, you know,
external sinking funds, things like that. We don't have a whole lot of
wiggle room. The regs are pretty clear.
Dose modeling? You know, we have a code, and, you know, how
are you going to move from specific -- excuse me -- from screening to
site specific, how are you going to factor in these difficult cases,
things like that.
I'm writing a lot of the modules that aren't on here, for
example, facility operating history, you know, things like that, and
those you have to generate from whole cloth. But clearly from a
technical standpoint, dose modeling is going to be the tough one.
DR. HORNBERGER: I would be interested in hearing some more
discussion about dose modeling, but before we do that, do you have a
gut-level feeling about how you're going to handle ALARA?
MR. ORLANDO: Chris McKinney unfortunately is not here, he's
out in New Mexico today, but he has identified some of the issues. The
principal issue with ALARA is making sure that it's an a priori kind of
an assessment. There is a lot of concern -- ALARA can kind of be
handled two ways. I mean, you know, sort of traditionally, you can look
at it and say, well, here's my dose and that's the amount of material in
the dirt or that I'm shooting for, and the dose I'm going to get from
that, and if I clean up six more inches, how much is that going to cost
and what's the dose benefit.
There's also what Chris likes to think of as rolling ALARA
assessments where you're doing those kinds of things as you're looking
at imbedded pipe and as you're looking at each -- as you come across
individual situations at the site, where perhaps you would maybe not
have as good characterization as you need. So you start chasing
contamination through the soil.
Well, all of a sudden, you've got to start making ALARA
assessments at that point, because if you thought it was going to take X
amount of money to clean up to a certain level -- don't forget, ALARA is
below 25, so we're already, you know, safe.
If you wanted to take it to 23, all of a sudden, if you've
got to dig 75 more feet or 75 more cubic feet of dirt out at a cost of a
couple of thousand dollars a cubic foot, all of a sudden, you've got to
start making ALARA assessments at that point, and those are the kinds of
things that he's having -- wants to get, you know, down.
MR. LARSON: Yes, but the SRM on ALARA said that in
addition, if the licensee complies with the 25 millirem dose criterion
using the screening, the licensee will emit the intended ALARA
requirement and additional demonstrations may not be necessary.
MR. ORLANDO: That's for soil.
MR. LARSON: Okay.
DR. HORNBERGER: But as far as the dose modeling goes,
you're first overhead related to the D and D code and testing it at a
complex site, et cetera, et cetera.
MR. ORLANDO: Yes, sir.
DR. HORNBERGER: Tell me a little about the dose modeling
and to what extent does it cover what was on the first of your overheads
and to what extent does it go beyond it for more complex sites. You
mentioned site specific. How is this all going to play out?
MR. ORLANDO: Okay. If I can, I would like to turn it over
to Bob Eid. He's the project or the group leader for the dose modeling
group. If that's all right with you all since he's the one who --
DR. GARRICK: Yes. I think that would be good.
MR. EID: Good afternoon. My name is Bob Eid. I am here to
answer your questions about dose modeling. I will try.
As you know, dose modeling is very complex, lots of issues.
We try to deal with the issues as much as we can. We try to interact
with the users also to look into what are the issues that they face when
trying to use the current tools that we have or the tools currently
available for dose modeling.
As you know, the current tools for dose modeling, most
licensees, they use -- they have two options. They have the D&D version
1 code that we have, and this is the NRC code, and we said this is a
screening code, it's for a two-year period. We found that also the
license, mostly they use RESRAD. The licensees tend to use more RESRAD
rather than D&D screen.
Now, you asked the question about what are the issues in
dose modeling. There are so many issues -- where to start?
Let's first see, just to give you two or three or maybe four
issues, for the current code that we have, version 1, we have the issue
regarding alpha emitters for surface contamination. The alpha emitters
for surface contamination, DCGL, those guidelines -- currently they are
very low. They are not detected at all within the limit or with the
fluctuational background. That's an issue. We struggled with that
issue early in the process. We tried to generate default tables for
licensees to use. We were successful in generating default tables on
D&D version 1 for beta and gamma emitters, but we were unsuccessful in
developing default tables for alpha emitters. That's the first issue.
The second issue that we have about the methodology of D&D
version 1.0, the methodology we tried to -- NMSS staff expressed their
concern from the beginning that the current methodology tended to
exaggerate or to be conservative, such that there would be a dose,
higher dose that maybe is not needed -- in other words, to increase the
risk -- and the answer was, well, this is screening methodology and we
understood that. But I guess there were presentations also in this
regard, and everybody understood yes, it is screening and we like to
take it as screening methodology and we should accept that excessive
dose.
Now, working with the code, we found that from this
workshop, they were very usual, that the licensees, they did use the
code, and they came with numbers, and they found that for certain
radionuclides, these doses, they are practically unacceptable for them,
and they called them anomalies. An example for those, they are the
cesium values and the strontium 90 values.
To put you in perspective, if you are interested in knowing
numbers, the current version 1.0 produces doses for unit concentration,
one pico curie per gram, of about around 60 millirem per pico curie per
gram. However, if we use, you know, the Sanuleta report where they
listed single radionuclide source, they assume not all radionuclide
source, all come back to the reason behind this extra dose, that it is
-- you will find that the value could be 14 millirem for strontium 90.
For cesium, the unit concentration dose currently in D&D version 1 would
produce about 28 millirem, whereas in the report using single
radionuclide value, would produce -- also be around fraction of
millirem. So you could see the difference in the doses.
The reason for having these extra doses currently, because
the methodology tends to be over-conservative and tried to assume that
you have all radionuclides listed in the table at your source.
So in other words, just to articulate this, to be honest in
my giving you the presentation to reflect also research point of view
according to what they said, okay, these anomalies in the version 1.0
for some radionuclides -- again, not for all radionuclides -- they're
related to the high dose values generated using version 1 as compared to
using single radionuclide input, and they are called both artifact of
the current methodology to select a solution representing the single
default set for all radionuclides. That's what the have. And this is
-- I guess it's a significant issue. The question, is this such kind of
high difference in the dose, and everybody recognize that extra dose
there is not needed, because at the end, you have a default parameter
that's indeed for when you have all radionuclides to establish single
set or default parameter for all radionuclides sources, you will end not
with the 90th percentile of certain parameters, you will end with the
99.9 percentile of that parameter. So this is -- that's, you know, I
think a serious thing that we need to consider, whether to -- you to
accept whether the licensee can accept this extra dose between one
millirem or 28 millirem or between 14 and 16 millirem or not.
If we agree that it is not -- it is an excessive dose that
is not needed, then maybe you will need to modify the methodology
currently and D&D.
The answer to the question of what to do about it already
exists, and it was realized earlier that the -- possibly this excessive
dose could be resolved by having the Monte Carlo version, where in the
Monte Carlo version, you try to avoid -- you put your single
radionuclide or the mixture of the radionuclides that you have and then
develop default parameter, see if that corresponds to these kind of
scores. So by doing this, you will minimize this kind of excessive dose
that's currently in D&D version 1.0.
Another third issue also, the input parameters in the
current code, and we talked about it and we said this represents all
kind of conditions across the United States, represents all
radionuclides, and these input parameters, they are conservative
somehow.
We found there are certain parameters that are quite
conservative. Almost there is consensus among the group that they need
to be changed. An example of those is the mass loading factor for plant
reposition, and this is a number almost everybody agreed that needs to
be changed.
Another factor which we spent lots of time in the discussion
in the dose modeling group is the resuspension factor for indoor. The
resuspension factor for indoor, we find the PDF is constructed on data
which was taken in 1964, published data, and the number of data points
here are two, although they were also data points for that specific
reference that was quoted.
We tried to look at the PDF again to look critically at what
kind of data we have, and we find we understand that yes, it is
conservative. We were at first with the situation, okay, what to do
about it, what alternatives we have. We found that we need additional
data.
We tried to look at additional data, and the workshops, they
were very successful trying to communicate with the industry and plead
for them to give us whatever site-specific data they have. I would like
to record that we were very successful on the one that -- the industry
cooperated at the workshop. They were so successful in getting actual
data that were measured over years by the licensee that they were not
aware of, and there were several presentations about resuspension
factors by industry. There were honest and true presentations by us and
new suggestions.
I think possibly, if -- still we are not in complete
agreement within the group. If we agree, we have consensus agreement,
we could move forward to modify resuspension factor. If we do that,
based on our recommendation that not everybody agrees, of course -- as
you know, this is technical discussion not everybody agrees on. If we
move forward this that, we could modify the alpha surface contaminations
by possibly a factor of 18 to 20, and we will be now in the working
region, the measurable region of dose.
Those are some of the issues. There are other issues that,
you know, I would like to give you more time if you would like to ask
any other questions.
DR. HORNBERGER: Just a short follow up perhaps. What
you've described, you're right, I mean, these are interesting technical
issues. It appears to me that you have your ideas well in hand for how
you're going to collect data and perhaps modify the code and change
default settings. In other words, you've given us a good indication
that you have the road pretty clearly mapped out in front of you as to
how you're going to solve these technical problems.
Do you see any technical problems din the dose modeling that
you don't have a clear idea of how you're going -- that is, are there
some big questions that really aren't even resolved conceptually?
MR. EID: Really, I do not know specifically. The only
problems that I know, that the licensees are using one code and we have
another code, and we are trying to use and to improve our code as much
as we can to make it more useful for screening. Our code has
limitation, as I said before, and we tried to balance to see what are
the limitations and to what extent we can use our code, and to what
extent that we could allow the licensees to use our other codes and how
we evaluate that.
We found that RESRAD, as you know, is a very popular code
used by the licensees. Now the question is, when the licensees, they
submit RESRAD to us, we have no information about how to assist the
conservatism in RESRAD, how to assist these parameters. We are working
on that. But also, we need to start with this -- the Commission, they
told us to have risk-informed, you know, based regulations, so try to
look at RESRAD, and currently it's more deterministic. They are working
on a probablistic version, which is not workable. So that's the reason
we tried to develop -- we developed a scope of work for RESRAD, a RESRAD
probablistic, and we tried to have some kind of similar approach which
we adopted, actually, the probabilistic approach. That's one of the
issues that we struggled at the beginning, to go to probabilistic or
deterministic. We agreed that we would like to go to the probabilistic,
although we cannot completely say, if licensees submitted deterministic
with sufficient justification, just ignore it completely, but we've said
that's the route we'd like to see.
Therefore, we are working on it such that if licensees, they
submitted RESRAD for site-specific analysis so we could have a feeling
and we could have the tool to assist what kind of conservative
assumption they have. The question is, can you use other codes for
screening analysis. Then the issue will be, you have two default
values, for example, and how you deal with that.
I think if we succeed in modifying our code currently and we
have trust that yes, the numbers are workable, they are good and they
are prudently conservative rather than excessively conservative, I could
say that it is a step forward.
Possibly we may find out that there are some comparable
results between -- if we have probabilistic RESRAD -- between RESRAD and
D&D. So if we do that and they are comparable within, say, 10, 20
percent, I mean, okay, we will accept that. We could say you could use
any code even for screening. But currently, because we do not have
sufficient confidence in the level of uncertainty and confidence in the
dose levels that are derived, we say we will use D&D screen for
screening. However, for site specific, the licensees could use any
other code, but they have to do, you know, the uncertainties and
additional justification based on site-specific conditions.
DR. GARRICK: Can you say a few things about what you're
actually doing to make the analysis probabilistic?
MR. EID: Yes. What we are doing, already, as you know, D&D
is a -- it is originally probabilistic but currently version 1, it is
not probabilistic, it is deterministic, because the input parameters,
they are single default data, they are inputted in the code. So the
PDFs for the different parameters were selected based on probabilistic
approach; however, they are single values currently in version 1. But
we are doing work -- I guess there was a previous presentation by
Research about developing a Monte Carlo version of D&D. It's called
version 2.0. So we are hoping this version will be accessible to use by
the staff and the licensee as soon as possible.
Our information, that this will be within six to nine
months, that would be produced assuming that the contract is placed.
DR. GARRICK: How are you going to obtain the PDF input
parameters?
MR. EID: For RESRAD or D&D or --
DR. GARRICK: D&D, yes.
MR. EID: For D&D, already there are PDFs, but they were
used for, you know, at the beginning, to start with, for singular
radionuclides. And then we tried to generate PDFs by having mixing
those -- all of these radionuclides, mixing them together. I tried to
generate a dose which is, say, the 90th percentile of the dose based on
those PDFs. So the version -- this is version one. version two will
try to input the PDFs that they could respond to that radionuclide
mixture or to that specific radionuclide.
For example, currently, the code will assume all
radionuclides that you have there and will try to modify those PDFs
slightly in order to accommodate the 90th percentile level confidence
for all radionuclides, regardless whether it does exist or does not
exist.
The version two, it will only account for the PDS that
correspond only to the radionuclide present at the specific site.
DR. GARRICK: So is that how you deal with the site
specificity?
MR. EID: Right.
DR. GARRICK: Because the screening -- when it's screening,
it's really not probabilistic because it's a table of PDFs, right?
MR. EID: That's correct.
DR. GARRICK: All right.
MR. EID: That's correct. So hopefully, possibly if we find
that -- from Monte Carlo version, we may look at, say, fuel cycle
facilities, they have specific radionuclides, could be five, six or ten
radionuclides, so you run the code and see those correspond to this kind
of source term; or if you have a nuclear power generator facility that
has a specific source term, you only consider radionuclides for that
specific source, you do not need to consider other kinds of
radionuclides, that they may be an outlier causing the dose to be very
high.
DR. GARRICK: Yes.
Ray?
DR. WYMER: Well, I did attend the January working group
meeting, and I thought there was a lot of good interplay between the
industry and the staff and found a lot of receptiveness in the staff to
the ideas that the industry came out with.
One thing that struck me, however, was that there seemed to
be, at least among a few of the industry people who stood up and talked,
a strong tide running for why we're fooling around with D&D when we've
got RESRAD, we know it works, we've been using, we're happy with it,
we've got experienced people with it. So we're still in that sort of
dilemma of having two different approaches.
What can you say about that now, Nick?
MR. ORLANDO: Well, I'll say what Cheryl Trottier said at
the last workshop whenever a question was asked, and that's that D&D was
an NRC staff code, it was developed, and it was -- since we had it, it
was put on the street for use.
I think Bobby indicated that, you know, it's appropriate for
screening right now, and that if licensees want to use that or RESRAD,
they can come in and just negotiate with the staff on which one they're
going to use.
DR. WYMER: I have a recollection that the two codes didn't
always come up with the same answer for the same situation.
MR. ORLANDO: And I think that's one of the things the dose
modeling group is looking at, is trying to make sure that, you know,
when the program version comes out or other versions of RESRAD come out
or the input parameters that would go into the RESRAD, the doses will be
coming out closer or, you know, within --
DR. WYMER: Within acceptable --
MR. ORLANDO: Within an acceptable range, I should say.
MR. NELSON: This is Bob Nelson from Division of Waste
Management. I would like to address that question, RESRAD versus D&D.
We've said this several times during the workshops and it's
important to stress that D&D was only intended originally as a screening
code. Because it was intended as a screening code, the default
parameters set were set at a very high confidence level to achieve -- so
that you would achieve a 25 millirem dose, and they were set based on
probability distributions of the various input parameters, and because
it was a screening code, the ultimate numbers were chosen, had to
consider already nuclides.
So regardless of what radionuclide you put into the code,
you're going to come up -- the default parameters stay the same. That's
one of the problems with using it in a site-specific way that Bobby has
talked about.
The RESRAD -- the basic difference between RESRAD -- one of
the basic differences between the two codes is the defaults that are
used. They were not determined the same way. The default parameters
for RESRAD were determined deterministically based on expert judgment.
So one of the things that we are doing is developing under a
contract -- Mark, maybe you can -- with Argonne to develop a same type
of probabilistic default parameter set for RESRAD as was developed for
D&D so that we have basically an apples and apples comparison rather
than an apples and oranges comparison. I think that will eliminate some
of the confusion between the two codes.
As Bobby talked about, we're developing the Monte Carlo
front end to D&D to eliminate this problem of not being able to look at
specific radionuclides and getting a more realistic dose out of the
code.
Both of these, of course, require time to implement. The
D&D Monte Carlo version won't be even at a beta -- test version won't be
ready until, right, nine months, sometime in the Fall, and a final
version won't be out until about a year from now. So we have this
interim period where we still have what we've got.
DR. WYMER: How will it impact your two-year
let's-see-what-it-does period?
MR. ORLANDO: That two-year is -- that's for the dose -- the
draft guidance GG-4006. That was put out, and the comment period on
that closes this year, August of this year.
DR. WYMER: But the trial runs will be done with the
existing version.
MR. ORLANDO: I guess what I'm saying is there was no
Commission-directed two-year time frame for evaluating the code.
DR. WYMER: Okay.
MR. NELSON: One other point I wanted to make, that even
once we have these -- so we are on a path to getting better -- code
working tools out there, but we still have another issue with the codes.
Once -- even if you have these probabilistic determined defaults in both
codes that are similar, how do you change to go from a -- the default to
a site-specific parameter? And if you change one parameter, how does
that impact the other parameters? What linkages are there and what
other parameters do you have to consider when you consider changing a
parameter?
That's another issue that the dose modelling working group
will be addressing during this development period, and some of the
guidance we're going to have to put out is how do you change default
parameters, what justification do you have to supply to change from
default parameters to site-specific parameters.
DR. WYMER: That does a good job of answering my question.
DR. GARRICK: I guess I'm still struggling a little bit with
the merit of a Monte Carlo calculation at the screening level where, you
know, uncertainty and probabilistic has meaning if you're talking about
a specific situation. But when you're talking about a generic
situation, I'm having trouble rationalizing what that means. I mean, if
you're just trying to demonstrate that Monte Carlo can do probabilistic
arithmetic, you know, we know that, but what's the significance of it?
MR. EID: I agree with you. I think the -- at the end, if
you think that you have all sorts of mixtures of radionuclides at your
site and all sorts of environmental conditions and then you need to go
look at the 90th percentile, and then when you apply it, you find that
you are not at the 90th percentile, you are at the 99th percentile, you
will have excessive dose for sure. The question is what to do about it.
This issue was raised and there was a suggestion for a grouping.
I guess there was also a suggestion by the ACNW, by the way,
about almost -- how many months? -- nine months ago in the presentation
about the grouping of radionuclides, for example, uranium and thorium,
or other kinds of radionuclides. This way, you could reduce the extent
of conservatism in this process, grouping possibly on -- based on soil
types, that you don't need to have KD value that corresponds to all
kinds of soil types and all types of geochemical conditions, a grouping
possibly based on environmental conditions like rainfall. So those are
the possibilities that, you know, we could do as far as screening.
MR. EID: This is Mark Thaggard. Would you like to add onto
that?
MR. THAGGARD: Yes. I think your question is why are we
trying to calculate the probability on this. I think the original idea
was to try to come up with the confidence that at any given site, you're
going to see the dose criteria, so that if you -- the idea was that if
you go into the dose assessment analysis with no information about the
site, these -- PDF is supposed to be based on national data, so if you
take any site in the country, just randomly pick a site no know nothing
about that site, and you run a dose assessment, what is the probability
that you're making a mistake by releasing this site when, in fact, you
shouldn't be releasing it. This was the original idea of trying to come
up with a probability. It was to give us some level of confidence in
terms of whether we are releasing sites that we shouldn't be releasing,
and there's some debate as to whether or not we are correctly
quantifying that, but that was the original intent.
I don't know if that answers your question.
DR. GARRICK: I think that's an expression of honesty.
MR. NELSON: I would like to follow up on that, because
Bobby brought up an example during his discussion of an existing problem
where, if you run RESRAD as it -- or D&D as it is now for strontium and
cesium, you get ridiculously high numbers. They don't make sense. And
that's because the default parameters set has been established based on
all radionuclides rather than given radionuclides or a given mixture.
What the Monte Carlo version will be able to do is you'll be
able to put in a specific mixture, it will calculate the default
parameter set for that specific mixture and give you a screening value
for that mixture.
We have done that. Bobby has looked at that for the
strontium and cesium, and have compared it to RESRAD, and the values,
once -- when you do this for a specific radionuclide mixture, they come
much closer to what RESRAD would give you for the same calculation.
They're not exact, but they're within an order of magnitude closer.
So that's the value. It's still a screening tool, but it
gives you a better screening value, a more realistic screening value
based on the radionuclides you have rather than assuming that every
radionuclide that -- is there.
DR. HORNBERGER: When you say it gives you a more realistic
value, more realistic compared to real data or more realistic compared
to RESRAD, which we don't know what the result means anyway.
MR. NELSON: Well, when I say realism, I guess it's a
subjective realism. When you look at what D&D gives you for strontium
90 at a pico curie per gram and it says that your dose is going to be 60
millirem per year, that, to me, is unreasonable. Okay. So by lowering
the number, that becomes to me more realistic. Whether it's the exact
right number or not, I don't know, but it certainly gives you an answer
that you don't say, well, that answer is worthless, 60 millirem. Of
course it's not 60 millirem.
So in the calculations that we ran, and these were
preliminary numbers, but the strontium dose went from 60 under current
D&D to a little under 15 with the Monte Carlo approach, and that's
compared to about five for RESRAD. So it's a significant change for
someone who is doing a screening review. I mean, if they can pass it at
15, but they've got -- if they've got 15 or somewhere in that range and
they're stuck with trying to screen 60, I mean, there's just -- you
know, it seems a significant difference there.
So I think it's -- I think the code -- the improvement is of
great benefit in the screening area because it's going to give numbers
that are tailored to the radionuclides that are of interest.
MR. LARSON: I didn't think it was two codes that were
similar for each different radionuclide. That's for some radionuclides,
one was higher than the other, and depending -- you know, so -- it
sounds like there was a lot of changing that you had to do to get
similar realistic or unrealistic results for each of the radionuclides.
MR. EID: I believe the two models here are different. They
would yield somehow different values. However, if you try to adjust the
source term to make it similar, say make RESRAD, the top 15, the
contamination the top 15 centimeter, and the thickness of the
unsaturated zone around one meter, that's one thing to try to shape your
source term, to make it similar to D&D, and then try to input a default
value similar to what we have in D&D, you will get, somehow, some
comparable values.
An example for cesium, I found that the -- after -- you
know, for a single radionuclide, if you do that, you will get 2.27 and
2.3. It is not a joke, those are real numbers. I ran them. They are
so close to each other.
So the models possibly -- yes, we had differences in the
models, and we may have differences in the peak dose at the time, I
guess. You know, this is also another difference because one model
tends to retard, other model tends to have infiltration and the material
moves much faster through the aquifer.
However, at the end, it looks like the numbers are similar
if you adjust the source term, the default values, and if you look at
the right time for the peak dose.
DR. GARRICK: Do you want to say anything more about the
workshops themselves and how they went?
MR. ORLANDO: Well, as Boby said, based on the comments that
we got from the participants, they were extremely appreciate of the fact
just in general that the staff is doing this outreach before we write
down what we think the answers are.
There is concern from the industry on exactly some of the
issues that you raised -- you know, why do we have two codes? You know,
what's going on here?
The industry, my impression, and this is just my impression
from the workshops and it may be rather simplistic observations, but the
industry, especially the nuclear power industry, is extremely concerned
right now about costs. They always have been, but with deregulation, I
think they're even more concerned. They are concerned about making sure
what they do is being done cost-effectively in decommissioning.
For example, they are very interested in seeing if they
can't take their thousand-acre site that is 95 percent buffer zone and
getting it down to something that includes the parking lot, the reactor
building, and the areas that actually have been impacted by operations.
They don't want to be in a situation where they're out surveying via
MARSSIM woods. So that's things that they've come to us and talked
about.
In addition, they are interested in making sure that when
they do the assessments that we're going to ask for -- and one of the
reactors have indicated they're going to come in for restricted use. In
fact, Paul Genoa from NEI has said that's not going -- that none of them
are planning that right now. But they have come in and I think they're
concerned about finality. They realize that, you know, the license
termination rule is relatively new, the Part 50 rule is relatively new,
they're struggling with sending in the first post-shutdown facility
decommissioning activities report, the PSDARs are just starting to come
in. That's the first thing that comes in when you shut down a reactor,
or after the certification.
Nobody sent in a licensed termination plan yet. They're
interested in the interlink between the decommissioning plan standard
review plan and the license termination plan review.
One of the things we did at the last workshop was very --
this question came up, and we did a very quick sort of ad hoc overview
of the interaction between NMSS and NRR with respect to reviewing
license termination plans and decommissioning plans, and I'm not sure
that the industry understood that, at least the power plants didn't.
On the materials side, their concerns are the same. They
see -- they're more used to dealing with decommissioning plan concepts
and things, so it's not too bad, but they still have the concerns that
the power industry has, finality, making sure that what they send in is
done, doesn't generate reams and reams and reams of requests for
additional information and additional justification and everything else.
One of the things that my management has told us is that
they want to see us start limiting the numbers of requests for
additional information to one. Have the interactions with the industry
during the reviews of the plans, publicly notice it, publicly -- make
that information publicly available, but don't have ten or five or
three, you know, sets of 60 questions going back and forth.
Then there are the technical questions, looking at -- you
know, finding alpha emitters, measuring that under the MARSSIM, partial
site release even for fuel facility plants, things like that.
So I think, to sum it all up as far as the workshops, I
think they've been good. I think the industry appreciates the fact that
we're doing this. I think they are slowly -- probably not by this time
-- they're comfortable with coming in and talking to the staff about
things that they find and problems that they have. So I think they've
been good.
That's just sort of my observations on the things that have
come up and the things that I heard while I'm sitting there in the
workshops.
MR. EID: I would like to add to Nick that in addition, the
data that is generated by the licensee and then we use, it is really
invaluable. The data is so important we do not find it in a published
paper or in a journal, and that is we -- after going through the QAQC of
the data and we feel confident using the data that they have, this will
give us one step further in moving towards using the right thing.
MR. ORLANDO: Yes, as Boby said, you know, for resuspension
factors, really the only study was what -- that's the '66 data, I think?
'64 data?
MR. EID: The reference we use is '63, '64 data, and we have
some skepticism from the beginning about the data, how it was used and
so on, but because it is the only reliable data -- it was published in
the Journal and has lots of data points, so we use references, and we
are updating this information.
DR. WYMER: There is a sort of a sleeper out there with
respect to this decontamination and termination of license and
restricted license termination that has to do with the potential
ultimate role of NRC and what are now DOE's problem.
You know, if you take over regulation of the DOE sites, what
thinking have you done with respect to that? And the kind of thing I'm
thinking about in particular is when you look over the DOE sites and
their potential long-range problems, one of the big things you see is
there's a lot of -- an awful lot of pump and treat going on forever,
essentially, because you never really do get the activity down.
Have you done any thinking at all or is it too premature?
You've got too much on your plate to even worry about that right now if
you do take over the DOE problems?
MR. ORLANDO: Well, officially, my understanding is that
Secretary Richardson has kind of pulled back from that a little bit.
There's not --
DR. WYMER: Yes, but secretaries come and go, you know?
MR. ORLANDO: Yes, that's true. Congress has not finally
spoken, so I'm not sure where that is going to go.
To be honest with you, no, I haven't -- or I don't think we
have thought about how we would manage a DOE facility other than if it
were to remain, you know, pump and treat forever, then it would remain
under some kind of license or some kind of regulatory control.
It seems, just off the top of my head, it would be
relatively easy to impose the restricted use criteria on that facility
in a 25 millirem, 100 millirem if there's a -- if loss of control, or a
500 millirem under the alternate criteria. Maybe a DOE facility -- you
could never terminate a license.
DR. WYMER: Yes.
MR. ORLANDO: And maybe there wouldn't be -- again, just my
opinion -- maybe there would not be any utility in ever terminating
whatever regulatory hook we have at a DOE facility if it's that badly
contaminated, or if they're continuing those kinds of operations.
DR. WYMER: Yes, but surely you're not turning your
attention to that problem until it becomes your real problem.
MR. ORLANDO: Right. Right now, we're just, again, trying
to -- at least for restricted use, we've enough things to do with the
fuel cycle facilities and other folks.
DR. WYMER: Yes. Okay.
MR. NELSON: This is Bob Nelson again.
I agree with Nick, we really haven't factored potential of
overseeing DOE into this development process, but DOE has --
representatives have attended the workshops and they have commented on
various issues as we go through them. So they have been a participant,
and we hope they will continue to be a participant in the workshops.
So we value their input, but we're not, within the scope of
with document, trying to -- looking at it as potentially encompassing
DOE sites.
DR. WYMER: Are you making sure you're not building yourself
into a hole? If that does happen -- I don't see anything in it that
would indicate that you are constructing a situation that you won't be
able to dig out of if you do take over the DOE stuff.
MR. ORLANDO: I don't think so. I mean, if they're going to
go for unrestricted use, they can --
DR. WYMER: Well, unrestricted, there's no problem with it.
MR. ORLANDO: Yes.
DR. WYMER: It's the restricted use.
DR. GARRICK: At DOE, it's a problem.
MR. LARSON: At the last workshop, the DOE guy got up and
said, I don't care what anybody else is using, but we're using RESRAD.
MR. ORLANDO: That's true. That was a DOE guy, yes.
MR. LARSON: One question on the schedule. I ought to
remember it, Nick, but I don't. You're coming back into the committee
after you get the public comments and gin them up so -- isn't that
towards the end of the year?
MR. ORLANDO: I believe so, yes, or we can come back at some
other time if you're interested to discuss some of the issues after
you've had a chance to think about them. I think -- I would have to go
back and look at the actual time line that we did. I mean, I can't
answer it --
MR. NELSON: We're scheduled to issue or complete the draft
modules with the exception of dose modeling in June, so if we're no
schedule, everything should be done but the dose modeling guidance in
June. If you'd want to have a brief in the late -- I don't think you're
meeting in August or September, so if you -- if you want to have a
briefing in July on the SRP up to that point, we could probably do that,
but we would have to look at the specific schedule. But it might be too
close to actual completion of the SRP to do that. Maybe the early Fall
would be a better time. We'd have completed most of the workshops by
that time and could probably -- and would be a lot further along on some
of the dose modeling issues at that point to give you a better status
report.
DR. GARRICK: Any other comments, questions, discussions?
Thank you for the update.
MR. ORLANDO: Thank you for letting me introduce the people
who sat over there who did most of the updating.
DR. GARRICK: And I think we'll take our second break at
this point, and I guess we'll go off the record for the rest of the day.
[Whereupon, at 3:50 p.m., the recorded portion of the
meeting was concluded.]
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