ML22230A211
| ML22230A211 | |
| Person / Time | |
|---|---|
| Issue date: | 04/26/1978 |
| From: | NRC/OCM |
| To: | |
| References | |
| Tran-M780426 | |
| Download: ML22230A211 (1) | |
Text
' TO SECRETARrAT RECORDS NUCLEAR* RECULATORY COMMISSION..
IN THE MATTER OF:
PUBLIC MEETING Place -
Washington, D. C.
Date -
Wednesday, April 26, 1978 ACE - FEDERAL REPORTERS, INC.
Offici.ai Reporters 444 North Capitol Street Washington, D.C. 20001 NAT!ONWIDE COVERAGS
- DAILY Pages 1 -
40 Telephone:
( 202 ) 34 7-3700
(
DISCLAIMER This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on April 26, 1978 in the Commission's offices at 1717 H Street, N. l1/.~ Hashington, D. C.
The meeting was open to public attendance and observation.
This transc~ipt has not been revie\\*Jed, corrected, or *edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes.
As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed.
Expressions of opinion in this transcript do not necessarily reflect final determinations or beliefs.
No pleading or other paper may be filed with the Commission in any proceeding as the result of or addressed to any statement or argument contained herein, except as the Commission may authorize.
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NUCLEAR REGULATORY COMMISSION PUBLIC MEETING Room 1130 1717 H Street, N.W.
Washington, D. C.
Wednesday, April 26, 1978 The meeting convened at 1:40 p.m., Chairman Joseph Hendrie presiding.
COMMISSION MEMBERS PRESENT:
Jbseph M. Hendrie, Chairman Peter A. Bradford Victor Gilinsky
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P R O C E E D I N G S CHAIRMAN HENDRIE:
We have come to order, I see.
The Commission subject this afternoon is a briefing on the final report of the Naturally Occurring and Accelerator-Produceq Radioactive Materials Task Force, known as NARM Task Force for short.
Lee?
MR. GOSSICK:
As you read the title, I am struck by the acronym that would have resulted if they had used all of the words, no arm, but anyway, Don Nussbaumer is going to give the briefing on the subject, Mr. Chairman.
CHAIRMAN HENDRIE:
Don, please go ahead.
MR. NUSSBAUMER:
By way of background, the NRC was asked to look into the matter of taking jurisdiction over NARM by both agreement states and the National Conference of Radiation Control Program Directors which consists of all 50 states.
We formed a task force in 1976 and produced a report which the Commission approved the issuance of for public comment.
We have now analyzed the comments, and the Task F.o:i::.ce has made a recommendation which the major offices have endorsed.
The representatives of the Task Force include persons from Nuclear Material Safety and Safeguards, Standards
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25 Development, Inspection and Enforcement, and the Executive Legal Director.
3 In addition, we had the benefit of resource persons from the EnYironmental Protection Agency who are represented here today, from the Food and Drug Administration who are represented here today, and from the Agreement States and the National Conference.
And we have a representative, Mr. Jim Blackburn, from the State of Illinois who helped us out on behalf of the National Conference.
(Slide.)
The naturally occurring and accelerator-produced isotopes has been a subject of continuing concern going back to pre-~orld War II days.
The second slide, please.
(Slide.)
The usage has remained fairly steady over the years.
You can see from this slide that out of 20,000 specific licenses for bj-product source inspection nuclear material, about 6,000 of those licensees use aNARM of various kinds.
And the principal use of NARM is --
MR. GILINSKY:
What kind of license?
MR. NUSSBAUMER:
Isotope radium.
MR. GILINSKY:
What licenses are involved here?
Are you talking about NRC licenses?
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MR. NUSSBAUMER:
In the 20,000.
It includes the Agreement State licenses.
MR. GILINSKY:
Right.
You are saying in addition to the materials covered by NRC Agreement State licenses, they usually go to the material?
MR. NUSSBAUMER:
Yes, and often in the same program and in conjunction with the materials that we regulate.
So radium is the principal isotope of concern as well as of use.
MR. GILINSKY:
Why are you looking at our licensees.
Aren't there other users of these materials?
MR. NUSSBAUMER:
There are two categories of users.
One are those that use the materials that we or the Agreement States regulate.
And the other category are those that use NARM.
What we are saying is that the programs that use the materials that we regulate are also using NARM.
This is the purpose of the slide just to show that there are very few users of NARM per se.
MR. GILINSKY:
I see.
But that wasn't evident from the slide.
MR. NUSSBAUMER:
No.
I am just trying to show the extent of usage of NARM by the slide.
MR. LUBENAU:
.The Agreement State experience has been that about 5 percent of all their licensees use NARM
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only.
And the remainder use either by-product sources. in speci nuclear material or those materials plus NARM.
That particular slide just indicates that of all the specific licensees, of all the people who might be subject to licensing, either ours or the Agreement States, 30 percent use NARM.
And of that, 25 percent use radium.
MR. GILINSKY:
You are also saying that this pretty much exhausts the users of radium in NARM?
MR. NUSSBAUMER:
Yes, that's it.
Right.
Next slide, please?
(Slide.)
The major uses of radium which we said is the principal isotope is in medicine.
And there, we have the principal use again in medicine is in what we call brachythera y which is an application of a sealed source to a cancerous tissue either by implant or by surface application.
There are some 1,800 medical facilities, hospitals and private practice., that are using radium today.
Next slide.
(Slide.)
The major uses in industry are, again, as sealed radiation sources in applications similar to those that by-product material is used in such as gages, static eliminators, and well logging tools.
And there, we have about 1;600 users.
Next slide.
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(Slide.)
In addition, there is a use of radium in consumer products.
The one of principal note is the smoke detectors where we have around 100,000 units sold annually.
Next slide, please.
(Slide.)
MR. GILINSKY:
Smoke detectors (inaudible).
MR. NUSSBAUMER:
The ionization smoke detectors contain either,radium or americium 341 which is the material we regulate.
So there are two kinds on the market -- the kind that are controlled.by us through authorized distribution, and the kind that are con trolled by states or,,,you know, with the advice and cons:ultation of FDA which contain radium.
MR. BRADFORD:
What is the breakdown?
Are most of them controlled by us?
MR. NUSSBAUMER:
Most of them are controlled by us, yes, sir.
CHAIRMAN HENDRIE:
Let's see,.we don't license the use of radium.
MR. NUSSBAUMER:
That's correct.
CHAIRMAN HENDRIE:
It..is a naturally occurring material, apd we don't class it as a by-product material.
MR. NUSSBAUMER:
Right..
CHAIRMAN HENDRIE:
Some states will and some states won't, I suppose, regulate it. Is there any federal control
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on it?
MR. NUSSBAUMER:
Yes, there is federal control.
We will get into that a little later.
The various statutes that the EPA has would allow it to control radium in all the various stages of use.
And the Food and Drug Administration has a voluntar program whereby they provide federal guidance to the states for regulating radium.
CHAIRMAN HENDRIE:
But that's a voluntary con-tribution.
MR. NUSSBAUMER:
Right.
CHAIRMAN HENDRIE:
And some states will regulate, and some states will not, I assume.
~R. NUSSBAUMER:
Yes.
We find that in the 50 states.
We kind of have a mixed bag.
All of the Agreement.::
States have a. licensing program for this material which is comparable to by-product source in special nuclear material.
So they run a total single program for radioactive materials.
Some non-Agreement States actually have licensing programs that are for radium or NARM.
Others have registratio
- programs.
And there are a few that have no programs.
Turning for a moment to the accelerator-produced radioisotopes, these materials go back to 1936 when E. o.
Lawrence-first produced a series of isotopes with his cyclo-tron.
And following that, they found early use in medicine
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for diagnosis and therapy.
(Slide.)
'The first successful use of an accelerator isotope occurred i~.19~9 when phosphorus 32 was used to.treat poly-cythemia vera.
The major uses of acceleratpr-produced radioisotope today are in.diagnostic studies and for calibration standards.
- .N.ext slide, please..
i (Slide.)
- The accelerator:-:-produced isotopes are on the increase in medicine apparently because the deliver a lower dose to the patient for these diagnostic studies.
And the FDA has bee:n advocating the increased use of accelerator-produced isbtopes over the fission isotopes because of this factor.
Next slide.
(Slide.)
~aturally occurring materials, of course, also occur in the fuel cycle, and the area we have been concerned with principally is that of uranium mill tailings.
And we note that tpe Commission decided last week to move for legislatio~ for that specific problem.
!)ur task force recommendation included mill tailing, but that*has.now been broken out to be handled separately.
Next slide.
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(.Slide.)
~his is just a listing of the various federal agencies that have one degree or another of control over NARM.
MR. BRADFORD:* Do any of them do the kinds of things that you are proposing here?
MR. NUSSBAUMER:
No, sir.
What we are proposing 9
is that NARM be incorporated into our existing regulatory pro-gram so that it is evaluated and regulated.in the same fashion as we regulate by-product source in special nuclear material, including the provision of turning that regulation over to states w~en they have a program that we consider acceptable.
MR. BRADFORP:
What, for example, does EPA do?_
(Slide.)
MR. NUSSBAUMER:
EPA has several authorities for controlling this material.
Some of them are implemented to greater degrees than others.
MR. BRADFORD:
Well, what do they actually do?
MR. NUSSBAUMER:
Their comment was that in total, they felt t~at they had sufficient authority to control this area under the e~isting ~tatutes.
, CHAIF{.MAN HENDRIE:
See, the naturally occurring stuff, they get pretty much under the Resource Conservation and Recovery Act, don't they?
MR. NUSSBAUMER:
Right.
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10 CHAIRMAN HENDRIE:
What about the accelerator produced MR. NUSSBAUMER:
Accelerator-produced material, I think, is a questionmark.
EPA's comment on this report was silent in respect to accelerator-produced isotopes.
The comment was they thought they had sufficient authority to handle naturally occurring materials under these various statutes.
MR. BRADFORD:
But do they actually have programs in these areas now?
MR. NUSSBAUMER:
In some cases they do, in some they don't.
CHAIRMAN HENDRIE:
Are the specifically radioactive materials listed under the Toxic Substances Act?
MR. NUSSBAUMER:
It includes radioactive materials, but by-produce source in special nuclear material is exempt.
Therefore, it would include radium, for example.
MR. GILINSKY:
Is there a lot of accelerator-produc d material?
MR. NUSSBAUMER:
.Yes, there is a fair amount of accelerator-produced material, and it is increasing.
Many of the universities supply accelerator-produced isotopes in the immediate area to their medical facilities £or diagnostic work.
It has been increasing.
We expect it to continue to increase because of this lower dosage rate to the patients.
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4 11 MR. BRADFORD:
At what point would you be proposing to take jurisdiction over that?
Would you be regulating the accelerators themselves?
MR. NUSSBAUMER:
That would be an option.
We drew s
a line in our task force recommendations that just the 6
material generated by the accelerator, but we noted that the 7
accelerators themselves are subject to the same kind of £rag-8 mented regulation as.the materials.
9 So an option would be to, in drafting legislation, 10 include the accelerators as well as the facilities themselves.
11 MR. BRADFORD:
Does it include elements out beyond 12 americium?
Is there any use for those things from the periodic 13 tabl~?
14 MR. NUSSBAUMER:
In the accelerator-produced isotopes 15 MR. BRADFORD:
Yes.
16 MR. NUSSBAUMER:
Yes, it would.
17 MR. BRADFORD:
Are they in use at all?
18 MR. NUSSBAUMER:
Yes, mostly for research-type 19 applications.
I wouldn't consider it extensive, no.
20 21 22 Next slide, please.
(Slide.)
Here is a summary of the state regulation of NARM.
23 As I mentioned, 25 Agreement States that have licensing programs.
24 Five non-Agreement States have licensing programs.
Twenty Ace-Federal Reporters, Inc, 25 states either have registration or are inactive.
That is, they
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25 12 have the statute, but no program.
Or they have no control program at all.
In addition, there is a problem with the premarket clearance of products and devices such as smoke detectors which in the case of the materials we regulate, we evaluate the design of the device before it is authorized-for dis-tribution... ::
The I?rogram that now exists is a voluntary one wher*
guidance is:: provided by FDA for the states to use.
But we run into a problem o.f. transferring these things to Interstate Commerce where one state reviews it, but the other state may not be sati~fied with the review* and so on.
The reviews*can vary from one state to another.
Ne.xt slide, please.
(Slide.)
Just an exarnple of a comparison in the area of smoke detec~ors between those that contain radium and those that contain americium.
You see from t:he third line down that the toxicitY, grouping for radium and americium are the same.
They are in:the most radiotoxic group.
And in the case of the radium detectors, there is no requirements for a*license to manufacture, an imp<?rt license~
M~ny of these are made outside this country, or premarket approval, although there is a voluntary program involved there.
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25 13 In the case of americium, we control all 3 of those finds.
Next slide, please.
(Slide.)
An example of a situation with radium detectors which I think demonstrates the variability of the controls is one that we found, our Inspection-Enforcement Office found, at Dulles Airport where they were asked to do a radiation survey of smoke detectors.
And they found that these radium
- detectors contain much more activity than the 0.1 microcurie shown on the previous slide, something on the order of 40 microcuries.
And they were reading on the order of 100 mr/hour Beta Gamma at the surface.
And the extimated.'exposure_to the people in the control tower was around 2 rem per year which is a significant fraction of the occupational exposure if you want to consider that.
The point is that this --
MR. GILINSKY:
Are these some kind of special smoke detectors?
MR. MUSSBAUMER:
Well, these were smoke detectors that were made some time ago.
They are an older kind.
They have more activity in them.
Of course, they had_several of them in the control tower.
And we have taken steps to notify FAA who has
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25 14 jurisdiction in this to --
MR. GILINSKY:
I guess what I am asking is why you point to Dulles?
This could have happened in somebody's house, I suppose, who had several smoke detectors.
MR. NUSSBAUMER:
I think it is possible.
We just happened to find out about this becaus*e we were called to do a survey of the smoke detectors in the control tower.
We were quite surprised to find this situation.
I just wanted to mention that as an example of the variability you have in control.
Next slide, please.
(Slide.)
So our overall conclusion was that the regulation of NARM is fragmented and not uniform and incomplete at the federal level.
Next slide.
(Slide.)
The states who have had the most experience with this material and who know where the gaps are have asked the NRC to step in and fill these gaps.
This is the reason we did this study and formed the task force.
Next slide, please.
(Slide.)
Our recommendations are that the NRC seek authority to regulate NARM:
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25 15 Where it occurs in the fuel cycle, noting that steps have already been taken to break out the mill tailings problem; Where it is manufactured; Where it is made into devices or sources; And where it is used in the same manner as NRC-regulated materials such as medicine and industry in gages and so on.
Next slide, please.
(Slide.)
NRC would regulate, then, the receipt, import, possession, use, distribution, and disposal, of these just as it regulates. these &ctivities for by-product source in special nuclear material.
Next slide, please.
(Slide.)
Under the Atomic Energy Act, we would also recogniz and relinqu~sh authority to qualified states, the Agreement State Concept,:.as we are now doing with our 3 materials that we have jurisdiction over.
MR. BRADFORD:
What do we do now to regulate the disposal of an americium smoke detector?
MR. NUSSBAUMER:
Well, since it is a consumer product, there is no control over the disposal.
The fact that it will be disposed of in an uncontrolled and random
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25 fashion is taken into account in the safety evaluation we conduct before we allow these things to be distributed.
And we have a safety analysis that we have pre-pared on this particular aspect.
16 MR. BRADFORD:
So when you are talking about regulating the disposal, for example, on the previous slide, with regard to radium smoke detectors, we are not really talking about regulating disposal necessarily; we are talking about assessing the impact of random disposal?
MR. NUSSBAUMER:
We would have to look at the design of the particular device and source ~nd quantity and make a decision as we do with americium, whether it was permissible to permit these to be disposed of in an uncon-trolled way.
The main thing we are concerned. about in disposal of the NARM is the waste that comes from the various uses of NARM in medicine and industry.
Next slide, please.
(Slide.)
We would not propose to regulate naturally occurring materials where they exist in nature.
For example, radon in caves or where they exist as incidental contamination in consumer products such as radium in building materials and so on, feeling that that is part-of an environmental problem that the EPA is more able to cope with.
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25 17 MR. BRADFORD:
When does it stop being in situ--.
that is, are you talking about when it goes into some kind of a process or MR. NUSSBAUMER:
Yes, sir.
MR. BRADFORD:
Not when it is first broken.out of the rock?
MR. NUSSBAUMER:
Right, when it is processed.
MR. BRADFORD:
We we wouldn't be regulating mines, for example.
.r.iR. NUSSBAUMER:
No, that's right, we would not be regulating mines.
CHAIRMAN HENDRIE:
What about things like tailings from phpsphate workings?
MR. NUSSBAUMER:
We would not propose to include that in thi~ particular request for authority since that is not part of.the fuel cycle.
MR. BRADFORD:
But neither is any of the rest of this.
MR. NUSSBAUMER:
Right, but then, we are not pro-posing that :these kind of sources of*NARM be included in any authority we would request.
MR. GILINSKY:
How do those tailings compare with our tailings?
CHAIRMAN HENDRIE:
I think they are pretty good.
I think there are more of them, and I think the radon emission
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~-- ---------
from them is -- somebody help out.
I suspect several times what we are getting out of the uranium tailings, at least.
MR. GUIMOND:
It is very significant.
There is probably about 10 times as much of the material generated.
The activity is probably about a tenth, probably about 10 or 18 20 times as much as uranium tailings generated.
The *material is made about a tenth of your average uranium tailing material.
And they are widely used for reclaiming or building structures on for a variety of thing's.
CHAIRMAN HENDRIE:
More dispe:i:-sed, and you are getting more radon up out of the material than out of our tailings piles.
MR. GUIMOND:
Right.
MR. BRADFORD:
Let me see if' I unde~stand that.
If you had the same quantity, the radon would be one-tenth?
MR. GUIMOND:
l'he radium concentration in the original material is approximately a tenth of the radium concentration in, say, your average tailings pile, but there is generated annually about 10 to 20 times as much of this materia as there is generated, say, uranium residues.
And they are for the most part generated in more habitable areas where there is a lot more people exposed to it.
MR. BRADFORD:
But if you used these tailings in construction somehow, you would have roughly a tenth of the
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MR. GUIMOND:
You have a tenth of the original source, that's correct, but it depends upon the use.
To give an example, put two examples, where they were used in, say, the Grand Junction area where mill tailings were used under and around structures, you had a small amount of the material used under and around structures.
And that contributed, of course, to the radon source getting into the structure.
Now, to give an example from Florida where structur s are built on maybe what we call an infinite depth of the material, 10 to 20 feet of the material, since there is considerably more material utilized there, even though the concentration is smaller, there is much more material and, therefore, the source material can be comparable.
MR. GILINSKY:
What is the source material?
What does that do to the radiation level, say, in the house in terms of, say other houses that would be built on that tailing?
MR. GUIMOND:
Radon decay product levels observed in structures in Florida that are built on this type of proble, have on the order of, say, 100 times, up to 100 times, norm.al background in radon decay product levels.
MR. GILINSKY:
100 x 100 rngs.?
MR. GUIMOND:.
No.
You are talking about, say, gamma.exposures, but these are measured in working levels.
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25 20 Normal exposure in a regular house, in working levels, which are the uni 1form radon decay products, is on the order of, say, O
- O O 2,working levels.
- Levels observed in these structures are up to, say, 0.2 working levels.
To relate that to -- well, put it this way:
it can be on the order of exposures that you c:ould get in the uranium mine.
MR. GILINSKY:
What does that come out to in terms of rems?
Wp.at is a working leyel?
MR. GUIMOND:
Well, there is a lot of controversy right now with respect to a direct conversion between working levels to r~ms because it depends upon the model that you use and how;you want to characterize the bronchoepithelium.
But basically the way we do it is -- I am from EPA -- we go back to the:: epidemiological work which is then related to deaths of, say, minors or people exposed to this related
\\
to working ~evels that they are exposed to, and then estimate a risk from there.
Alld then we estimate kinds of risks involved here.
MR. GILINSKY:
I see~
We are talking about exposur s to the lung~
MR. GUIMOND:
That's correct.
MR. GILINSKY:
Not the whole body.
gR. GUIMOND:
So basically, at the present time,
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- 20A, I
we estimate that people living in some of these structures down -- say if you live in. a structure in Florida, one of the higher ones I am talking about 0.2 working levels -- you could maybe up to 10 times or more your risk of lung cancer than the normal risk you would have.
If you assume that a normal lifetime rish o~_lun~.
cancer is on the order of 3 per*l00, then it can be significant MR. GILINSKY:
You say it would be 10 times that?
MR. GUIMOND:
Yes, if you lived, say, a lifetime in that type of a structure, exposed to that upper level that I estimated, from some places that we have observed, it could be that high.
MR. BRADFORD:
And are there particular groups that are more sensitve and susceptible?
MR. GUIMOND:
Well, that*s*a bit of a 9ontroversy right now as to whether or not, say, exposure to children is more significant than exposure to adults.
There is some folks that would say yes, other folks that would say no.
MR. NUSSBAUMER:
May I have the next slide, please?
(Slide.)
The next slide is a summary of the comments that we received on our report.
of the 25 comments we received, 21 agreed with the recommendation that we had made., 2 dis-agreed.
One was EPA, and one was an industrial concern.
And 2 expressed no position on the matter.
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25 21 I MR. BRADFORD:
The basis for EPA's disagreement was that they had adequate authority already.
What was the basis for -- was it Westinghouse?
MR. NUSSBAUMER:
Yes.
They just felt that there was enough federal regu-lation already without anything more.
~ext slide, please.
(Slide.)
We feel that some of the benefits of NRC.* assuming jurisdiction over NARM are:
- 1.
To enhance radiation safety for the workers and the public in the various areas wehre NARM is used.
- 2. It would sim!)lify the regulation of NARM by centralizing; it essentially in one agency.for those areas that we had !!carved out.
It would provide a comprehensive control within an existing competent federal program which is already operational And it would recognize and enhance the role of the states since this could be then turned back to them to regulate when they* have demonstrated an adequate prog,ram.
Jmd finally, it.,,would require what we consider to be a minimal ad?di tional federal effort on our part.
May~ have* the next slide, please?
T,aken into account the fact that most of the people
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25 22 who use NARM ar~ already NRC licensees, we estimate about 7-person years would be required in the way of resources which is roughly equivalent to $500,000.
Next slide, please.
'(Slide.)
MR.* GOSSICK:
Don, I think *a question on that point is in fact is such manpower required?
How did we ascertain outside of the 20,000 licensees are also using NARM; that there aren't some:excellent or other people using NARM that are not licensees now?
MR. NUSSBAUMER:
Well, we did take that into account.
We took into accou~t those people who were not NRC license~s, but in non-Agreement States and that we would have to license who were using NARM.
MR. GOSSICK:
Thank you.
I think you indicated to Commissioner Gilinsky that was a relatively small number com-pared to the 20,000.
My question is:
how do we know?
MR. LUBENAU:
We rely heavily on Agreement State.
experience.
We ask them what percentage.
We determine from their experi,ence what percentages of the Agreement State I~
licenses ar~ also using NARM or using NARM only, and then projected that across the country.
MR. NUSSBAUMER:
Next slide, please.
(Slide.)
To summarize, we feel that federal control is
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25 23 needed to PFOtect the public health and safety in this area.
The public ~omments did support the NRC taking on this responsibility.
NRC would appear to be the logical agency since it has an existing and.similar program already in effect.
The cost would appear to be minimal.
And the need for NRC authority over NARM and mill tailings has already been established, and separate efforts are underway to get that authority.
That is the end of the presentation.
CHAIRMAN HENDRIE:
Let's see. It appears to me that a good deal of the incentive for.this additional licensing authority which you would seek comes from the Agreement States.
Anc:l. I expect that is reasonable enough because in the Agreement States, there are presumably state offices that are established'to deal on the one hand with us and on the other hand with a.;tl of the by-product material licenses,. the authority to regulate, which same we turn over to the state
- 1 in the agre~ent.
To the extent that those states have authority or want to reg~late other radioactive material that are use*d in similar way'[f,, I can see where from their standpoint, it probably would be handier to have federal authority invested in NRC to flow back to them through the NIRC agreement.
And it fits very well within their pattern.
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25 24 So I can see why from the states.' standpoint they would recommend this increase, this additional regulatory authority here with us.
On the other hand, the proposed extension is aimed primarily at naturally occurring or accelerator-produced radioactive materials that in fact have uses that are rather similar to the sorts of uses that by-product materials are now put to...
But there are certainly a lot of naturally occurring radioactive.. materials.
And I dare say not inconsequential amount of ac;:celerator-produced material which doesn'.t fit this sort of a pattern, which is the phosphate mined tailings and so on, which we would not presume to become involved with.
So I don't know that I really agree that this progra covers the NARM field in a comprehensive way in the sense of sweeping all of these materials into one cohesive federal control poin~.
It seems to me that substantial amounts of these materials a~e left to be deal.t with by primarily, I guess, EPA under t:q:e assorted authority that they have.
Sd I wonder if it really is as neat as it sounds at first blush.
MR. NUSSBAUMER:
There are 2 points on that, Mr.
Chairman.
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. 25 25
- one is the proposal could be more comprehensive.
In fact, tqe Executive Legal Director suggested in his comments on our pap~r that they felt that since the going for additiona authority in this area might be controversial anyway that the NRC might well consider asking for all encompassing authority over this.
CHAIRMAN HENDRIE:
You mean if you are going to get shot at, you might as well go for
/ffi.. NUSSBAUMER:
Right.
You might as well go *for something oig.
'CHAIRMAN HENDRIE:
Right.
We might as well pick a bushel of apples as long as he is going to shoot at us anyhow.
MR *. NUSSBAUMER:
A second point is -we found out in our study that there_are areas where we think there is a radiation safety problem.
It is hard to tell because of a lack of data -- things like consumer products, leaking radium sources, you know.
Because there is no one to review the design and -quality assurance on the source manufacturer, no one to review the, in many cases, design of some of the consumer products before they are distributed in the public domain.
And there are a limited number -- I think it is around 300 or so -- medical and industrial firms using these materials where the control program is variable.*
In some cases, theie could be no regulation at all
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25 And we felt in these areas, it was worthwhile filling in those gaps so that the country has a uniform radiation protection program for those materials, those radioactive materials, that are used in similar ways by-product source in special nuclear material, and then NARM as well.
26 See, we control in the medical area, for example, the use of many isotopes.
CHAIRMAN HENDRIE:
What you do then is to recut NRC's authority lines from description which says, "Well, its source of material or by-product material, special nuclear material, and if it isn't one of those as, duly defined, why, it isn't ours."
MR. NUSSBAUMER:
Somebody else's.
CPAIRMAN HENDRIE:
You. go from there to saying, "Well, NRC authority extends to either some or all consumer products using radioactive materials, whatever the source of those materials."
I am not sure one would want to say all consumer products.
MR. LUBENAU:
The task force did make a distinction that we had no intention of getting involved in the regulation of consumer products where the radioactivity was there incidentally as, for example, building materials.
What we did intend in our recommendation is that the regulation extend
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25 to products: where radioactivity is introduced deliberately and for the* purpose of utilizing its radioactive properties such as smoke detectors.
27 CHAIRMAN HENDRIE:
Well, you go then, and you say, "Well~ the definition of source material, special nuke, bi~-
- 1 product, I will add a. class of fabr:i,cated products in which radioactiveimaterials are deliberately installed."
As Vic says, the next step is to say all radio-activity, reactors today, tomorrow, the world.
I don't think we can -- I would find it hard to go that far.
MR. NUSSBAUMER:
Which is why*
we tried to draw a boundary.,
~HAIRMAN HENDRIE:
We are not set up for it,.and there are other agencies with differently drawn authorities and statutes that come at that overall problem in a different way than we:do and perfectly legitimately.
But I think a fair question, instead of our pushing our authorii:,y out from where it now lies to take in this group of fabricated products, using radioactive materials, maybe the other fellow's authority which--* let's see, the EPA people feel they have.the authority to deal with this area~
I expect it could be made more explicit.
And since they have a:: general mandate about radioactive, about exposures, p:iopulatiori exposures, individual exposures, general
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10 11 12 13 14 15 16 28 dose limits,. and so on across the country, is it clear that it is better bhat we do it than it is that they do it?
MR. NUSSBAUMER:
Well, I think there are arguments for all 3 t)oints of view.
You mentioned 2.
A third point of view was: one that FDA expressed which was to give their voluntary program with the States whereby they provide guidanc on NARM matie;l='ials for the States, give that a chance to see if that would --
'CHAIRMAN HENDRIE:
It primarily leaves the authorit with the States with a voluntary federal technical program.
MR. NUSSBAUMER:
Assistance program.
<=HAIRMAN HENDRIE:
. That sort of thing.
MR. NUSSBAUMER:
The reason we are in it was because the* States asked us to assume the authority, and we thought, well, we need to have a short-term study to take a look at the problems.
We felt that for those things that are 17 used in the. same fashion as by-products in sources, special 18 nuclear material, it would be a simple matter, indeed, to pull 19 those into our existing program and take care of at least 20 that part o~ the problem, recognizing there were other problem 21 beyond that:of more environmental nature such as phosphate
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25 CHAIRMAN HENDRIE:
Ken, do you want to --
MR. PETERSON:
Yes.
Thank you.
Happily, one of my major concerns has been taken
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25 29 care of by the' movement of events.
The initial staff proposal that came up would have had a dr~ft legislation covering all of NARM, including mill tailings.
My concern was that that might result in us holding up the mill tailings legislation and not moving ahead with it.
- That has now been broken out and is moving ahead separate y.
So that concern of mine has gone away.
I think what you are left with, then, is the possibility now of considering moving ahead with a separate piece of legislation to just pick up this other NARM.
Now, one of the purposes of such legislation would be to deal with much of the overlap and uncertainty-that one of the charts showed.
And.the question that I raise, and I think that ELD partly raised, too, although I don't raise it in the context of us grabbing off more necessarily.
What I am saying is should we in context of moving ahead with this legislation, possibly moving ahead with this legislation, consider using it to clarify other areas of uncertainty in terms of radio-logical protection at the federal level -- transportation and Clean Air Act, OSHA, some of these other concerns?
Should it be an effort on our part to clarify and make more efficient, hopefully make more efficient, the broader radiological responsibilities, or should we seek
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25 30 just this small additional piece of, relatively small piece of NARM?
.. I. think it is a question the Commission needs to face.
My o~n view is that I think it is well worthwhile thinking tht="ough in making a decision here as to whether you want to use this as a vehicle.for some broader clarification or not.
I don't think that has been looked at.
My recommendation is that it should be.
I am not opposed to us seeking necessarily control over other-NARM, non~mill tailings NARM.
One more thing.
You are already in effect dealing here with jµrisdiction that NEPA claims to have; FDA's support was conditional support, although on the chart it counted as support. It is highly conditioned support.
You know, if you are going-to, with all due respect for the people who are here from these other agencies, take them on in these jurisdictional matters, perhaps you ought to consider** possibly taking them on or clarifying other areas where.. there is overlap, too.
And we have been briefed on that recently in several instances.
Thank you.
CHAIRMAN HENDRIE:
Let's see.
If I look over that way, you identified yourself from EPA, are you the only
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MR. GUIMOND:
I think so.
I don't see anybody else,here.
CHAIRMAN HENDRIE:
Would you 1ike to fit your two cents worth: in here?
MR. GUIMOND:
Well, I might say a few things relative to: us on::some of the things, some of the areas that have been spoken of.
I.was a member of the resource from EPA on the task force.
We made some of our comments known then.
The agency's probably principal authorities which were outlined on the board there are ones that give us authorit for certain types of uses like under the ':foxic Substances Contro:1 Act~
Now, it can be a fairly new act.
There has not been much in the.way of implementation, particularly with respect to radiological radioacti~e materials under that act to date.
There is still a certain degree of organization on that line.
Another act that comes along is the Solid Waste Act.
And in that vein, we are presently putting out criteria for hazardous materials.
And there will be performance fi standards out within, say, 6 months to a year, or proposed ones, addressing this type of sources.
And the same thing applies to the various other authorities*where we are trying to move ahead in this area.
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10 11 12 13 14 15 16 17 18 19 20 32 I, think the concerns that we had when we commented on the proposal that was sent to us by Don Nussbaumer was that, indeed, there seemed to be, :~ this proposal seemed to be, somewhat restricted.
That is, if, indeed, the intent was to get rid of federal ~verlap, get rid of duplication, bring the whole thing into$. focal point so to speak, then it would not achieve that by virtue of the fact that these emissions such as the in situ, such as the incidental places where radioactivity still will be there, will not be handled by this* and, *therefore will have tq have some addressing by EPA or somebody else under the various authorities that are available to them.
So for that matter, *there are st.ill goirig to be some fragmentation, if you will, of the radiological control for NARM materials.
- A;nd then, another factor was that if then you are going to try to, say, bring about control of certain NARM materials, waste disposal of them or certain uses of them which we concei vab',;J-Y would have authorities for, we could then either get ihto a situation of duplication of effort where we 21 both have authorities over it, or you would have..t6 have some 22 taken *away from us an.d given to you which, as you already 23 noted, I am sure, would have its own problems in getting 24 through one way or the other.
Ace-Federal RePorters, Inc, 25 So that is, I think, one of the key things that we
33 commented on from the standpoint of how it focused.
2 Why _aren't we then involved here with res*pect to*
3 the mill qu~stion, the mill. tailings question?_ I think our 4
staff is pretty much in agreement that during our licensing S
operations,: there are certain additional authorities that you*
6 need and*reguire and would support in that area.
7 But some of these other questions are ones that we 8
feel the* need may be highly questionable* in light of our 9
authoritiesior other agency authorities and don't really see 10 the need.
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25 CHAIRMAN HENDRIE:
Thank you.
Are there other* people from other agencies or state group~ that would like to. --
MR *. GOSSICK:
I think Jim Blackburn from Illinois would like to comment *.
CHAIRMAN HENDRIE:
Jim?
MR. BLACKBURN:
Thank you, Mr. Chairman.
Illinois is one of these 5 states that is a non-Agreement Licensing State.
We do license NARM.*
The State's Programs Group have not yet made us an offer that we can't refuse so we haven't got agreement yet, but.we did pick up the other side of the ball.
G:HAIRMAN HENDRIE:
We will make you a new offer.
.$R. BLACKBURN:
But in this unique position, we are finding several. problems.
We are finding problems all
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25 the way along the line, particularly with NARM sources that have not been evaluated.
34 I think that several of these sources would never have entered the marketplace if they were by-product material.
I think that this is by virtue of the fact that they are corning in now as almost entirely accelerator-produced materials sort of speak to that aspect that they can be produced without premarketing clearance.
Many of these are designed for nuclear medicine studies where they are taped directly onto a patient.
They are fairly small.
Many of them consequently are left on the patient, can be left there for many hours.
In fact, the situation that they may find it the next day when somebody decides to give the patient a bath and found that yesterday somebody forgot to remove the source.
Several of these sources, we have noticed have --
in fact, we have never found any that has taken a -- as part of their design criteria and incorporated shielding within the source or below the active portion of the source to reduce the radioactive exposure to the patient.
Many of these sources are manufactured in non-Agreement, non-Licensing States.
They are shipped under private label.
They may change labels 3 or 4 times.
And it is an extremely difficult problem to try to determine exactly how the source is manufactured.
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25 35 We are also finding that due to the emphasis placed by the NRC :on their agreement program~ certain Agreement States wheue they are forced due to budgetary restrictions are letting the NARM problem slide.
They can't do this with their by-product and source of special nuclear licenses, but they can with NARM.
I think that New York is one, and it is a case in point.
They have a major source manufacturing firm in New York State.
Many of these sources have not been evaluated properly.
I understand that some of them in fact are even using what they call pressure fit.
These are radium sources.
They have been out there for a long time.
Whether they are all double.encapsulated or not, no one really knows.
But this is the type of problem.
These sources are in the marketplace and are being used.
Now, who.is going to license it at.the federal level, I personally do not care.
But somebody needs to be ab:le to cov:er the waterfront at this level.
The second problem that we have run across is that as a state,*. and we* have several manufactUJ::ers within our state which we l.i;:cense, and as. a part of their distribution license, we prohibi ~'. them from distributing their sources. to anybody not licensed to receive it.
Jfowever, this does not cover facilities like a
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25 VA Hospital::*
And so the VA Hospital can buy and does buy an accelerat6r-produced source that we would not authorize the private* sector to buy simply because there is no one in the federal reana that covers::this type of situation.
36 We also have problems with certain of our licensees where due to their manufacturing.techniques, they incorporate both a source of by-product material and a naturally occurring source, ih which case, you have tremendous problems with the NRC on labeling.
Their labels are very legally formatted, which is fine, but in their legal format, they give no recognition:of a licensing state.
.fmd so how do you develop a label for a device that has both americium and radium, for example?
This has been_
a major prolJlem for us.
We are still trying to_fight it out.
We feel that this licensing of courses needs to be consistent and needs to be all-encompassing, as much as possibl.
When we have a brachytherapy source that is radium versus a brachytherapy source that is cesium, it would appear to us the regulations ought to be consistent.
The mechanisms need to be consistent.
And we have the same problem with waste disposal, this type o~ thing.
We are not saying that the NRC has had a spotless record; we don't either.
But we do feel that we need to get some clean federai jurisdiction over this problem to help the
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25 states* in solving our problems which are basically public health.
37 CHAIRM..~ HENDRIE:
From your standpoint, Jim, these problems are pretty well concerned to manufacturer, distri-bution and use of sources, very much of the same kind as use of by-product material?
MR. BLACKBURN:
Correct.
Many of them, in fact, the same source capsule is used for both materials which is another one of our problems.
Because it is evaluated for cesium and ends up in the Agreement State's catalogue.
And it is sort of incidental. It is also used for radium in which case that falls under our jurisdiction.
So you get this type of agency interactions that does not mesh real clean.
MR.. GILINSKY:
May I ask you aside from the fact that it is an administratively messy situation, what is the health problem?
You pointed to the Dulles Control Tower, but what do you think is happening out there?
What is the problem to which this is the answer?
MR. BLACKBURN:
The big problem, as I see it, is the distribution of radioactive sources without premarketing clearance by a competent regulatory authority.
And I personal y do not like to take the approach that any problem that needs to be solved, give it to the Federal Government.
I would rather have the states do it.
But there
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25 are certain states that either cannot or will not.
And in that case,,;it is impacting on my state if these states will not.
38
- If I have a source manufactured in Massachusetts and I cannot find out about it until.it has already been dis-tributed in my state, I have a health problem.
MR. GILINSKY:
Well, is there some data on the healt problem?
Are there people getting excessive doses because this material is not controlled or because it is mislabeled or whatever.?
Do we know that?
MR. BLACKBURN:
Particuljarly if you would use the criteria of ALARA, absolutely yes.
I think the regulations for both my regulations and the NRC' regulations says that ALARA is applicable.
You would reduce all exposures as low as reasonably achievable.
MR. GILINSKY:
Do we have some estimate of what the exposures are as a result of this material?
MR. BLACKBURN:
As Don mentioned, where there is no regulatio11-s, it is extremely difficult to get any valid statistics. If there is no regulations requiring reporting, nobody reports.
MR. LUBENAU:
If I can quote just quickly from a couple of** thOughts from the original task force report, a problem here is if you don't look, you are not going to* know that there is a problem.
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25 39 In many states which do not have programs, it is hard to say. that
- there is a problem because no one has been there examining it.
But if we can look at, for example, the Wisconsin s:tudy of 39 medical radium facilities found radiation levels in upcontrolled areas up to 100 mr/hour and 4 facilities wd:th workers in unrestricted. areas, may*
- have. received more than 50.0 mi1.li-rem in a year.
Initial surveys and medical users in 8 states disclosed b~tween 13 and 53 percent of the facilities possessed sources which)were leaking or were contaminated.
And then th~s is Dave Lacker* from Texas.
And unfortunately, Mr. Lacker who was one of the resource people on the task'force, and he could not make it*today.
They are having budgetary hearings in Texas.
And that obviously has a higher prio~ity for him.
He wrote to us and described some of their findings in Texas.
And I will not go over them, although he does mentio 25 reported'.lost sources.
But he then says:
These incidents -- in Texas.
represent to me a serious potential hazard since they occurred in.a regulating state.
What happens in those areas of the coun~ry where there are essentially no regulations requiring t~e usual radiation safety precautions?
CHAIRMAN HENDRIE:
Anybody else like to make a comment?
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25 L
(No response.)
MR. KELLEY:
I think Don should be complimented on his slides.
MR. NUSSBAUMER:
That is Mr. Lubenau.
CHAIRMAN HENDRIE:
Let me ask, do y.ou prefer to think about this a bit rather than try to take some action here?
I detect a certain reflective feeling.
40 MR. BRADFORD:
I don't mind waiting.
But my own inclination would be to go ahead with something pretty close to the recommendation.
Obviously, I would probably benefit from both of your reflections.
CHAIRMAN HENDRIE:
What do you --
MR. GILINSKY:
I prefer to wait.
CHAIRMAN HENDRIE:
I think I would like to mull on it a little bit, too.
All right, Don, we thank you very much for the good presentation and very interesting set of slides.
And we thank you all for coming.
,(Whereµpon, at 1 : 4 0 p. m., the meeting was adjourned.)
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