ML20134F706
| ML20134F706 | |
| Person / Time | |
|---|---|
| Issue date: | 10/24/1996 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| DSI-G-3-00002, DSI-G-3-2, NUDOCS 9611070152 | |
| Download: ML20134F706 (140) | |
Text
,
2 3 OfficicI Trcnscript sf Prseccdings 3 9 2
NUCLEAR REGULATORY COMMISSION c
Title:
Stakeholders Public Meetings Handling of Nuclear Materials
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2 a
Docket Number:
(not applicable)
Rggfpgg E
.NOV'n n I996 c.n
. ottice of the
,Y Secreta
- Location:
Washington, D.C.
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Date:
Thursday, October 24,1996 Work Order No.:
NRC-890 Pages 1-119 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 070014 1323 Rhode Island Avenue, N.W.
/
Washington, D.C. 20005
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j (202) 234-4433
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EoA*LRei 76 24 GEN PDR 0{'$hNi(CN in Ct. v10 h-L N N'S
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DI5 CLAIMER PUBLIC NOTICE BY THE UNITED STATES NUCLEAR REGULATORY COMMISSION'S STAKEHOLDERS PUBLIC MEETINGS OCTOBER 24,,
1996 The contents of this transcript of the proceedings of the United States Nuclear Regulatory Commission's Advisory Committee of the Stakeholders Conference on October 24, 1996, as reported herein, is a record of the discussions recorded at the meeting held on the above date.
This transcript has not been revi~ewed, corrected and edited and it may contain inaccuracies.
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UNITED STATES OF AMERICA l
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NUCLEAR REGULATORY COMMISSION 4
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5 STRATEGIC ASSESSMENT AND REBASELINING l
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STAKEHOLDERS PUBLIC MEETINGS 7
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ASSURING THE SAFE OSE AND 9
HANDLING OF NUCLEAR MATERIALS SESSION 10
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11 THURSDAY 12 OCTOBER 24, 1996 l
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14 WASHINGTON, D.C.
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15 The Assuring the Safe Use and Handling of 16 Nuclear Materials Session wLs held in the Lincoln Ballroom i
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17 of the Washington Hilton and Towers at 1919 Connecticut l
18 Avenue, Northwest, at 1:00 p.m., Malcolm R. Knapp, Deputy i
19 Director, NMSS, NRC, presiding.
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20 PRESENT:
21 MALCOLM R.
KNAPP 22 CLARE DEFINO l
23 CHIP CAMERON i
l 24 RUTH MCBERNY i
25 EDWARD RHINGHE i
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PRESENT: (cont'd)'
2 BOB CRITES 3
RICHARD RATLIFF 4
JUDITH JOHNSRUD 5
LYNNE FAIROBENT 6
LISA JARRIEL ROB MCDOUGAL 8
LAWRENCE J.
CHANDLER 9
STEVE COLLINS 10 CARDELIA MAUPIN 11 ROY BROWN 12 DICK BANGART 13 TONY THOMPSON 14 DARRELL McINDOE 15 TOM HILL 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 A-G-E-N-D-A 2
Aaenda Item Page 3
Oversight of the Department of Energy 5
4 Agreement States 38 5
Medical Materials Oversight 77 6
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P-R-O-C-E-E-D-I-N-G-S 2
(1:10 p.m.)
3 MR. CAMERON:
Okay.
Good afternoon.
We're 4
ready to start.
And, for those of you who are interested 5
in the international arena, or the research' arena, it is 6
next door.
And this session is going to be on nuclear 7
materials.
8 A couple of announcements.
First, if you need
)
9 the handouts from this morning's session, they're all a
10 going to be in the Georgetown West room, along with copies 1.
11 of any of the full papers that you would, you would like j
12 to have.
13 And remember that you can go down to the 14 Georgetown West room, and have your comments videotaped, j
j 15 or just, you know, if you want to do a song and dance, or 4
16 some comedy routine, I guess you can go down there.
- And,
{
17 speaking of -- no.
l 18 (Laughter.)
19 We have three papers for discussion this 20 afternoon.
And what we're going to do is we're going to i
21 go through each one, and then have audience participation, 3
22 and then go to the, the next one.
I 23 And the first one that we're going to be 24 looking at is oversight of DOE.
And then, I believe, 25 we're going to move to agreement states, or -- right?
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1 (No audible response.)
2 Okay.
And then we're going to talk about 3
materials medical oversight.
I 4
And Mal Knapp, who's Deputy Director of our 5
Office of Nuclear Materials Safety and Safeguards, was the 4
6 sponsor for all three of these papers, and Mal is going to 7
be doing a presentation on each of them.
So, as laid out 8
ih the agenda, we're going to go with oversight of DOE l
9 first.
10 DEPUTY DIRECTOR KNAPP:
Thank you, Chip.
I am f
j 11 pleased to work with Chip, not just here but, as you can i
12 see from the first paper, he is the principal writer of 13 this particular issue paper.
14 The question is whether this introduces a 15 conflict of interest, but we don't think so.
I've been --
16 I've worked with Chip for a number of years, ever since we 17 were in the same work release program back in the 18 seventies, and.
i 19 (Laughter.)
20 I think he has a very good product here for us 21 to discuss.
The issue at hand is should the NRC seek to 22 expand its regulatory authority and responsibilities to 23 include DOE facilities, i
24 A moment or two of background.
DOE is largely 25 self-regulated.
NRC does have a role, as probably most of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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you know, in some aspects of DOE operations.
Should DOE 2
apply for license application at Yucca Mountain, the NRC 3
will receive and make decisions on that application.
4 DOE has been engaged in over 15 years of work 5
on remediation of certain uranium mill tailing sites.
The 6
NRC has regulatory authority over those.
7 We are also involved in DOE in other areas 8
that are not strictly licensing, with equal rigor.
- But, 9
with certification, we've been involved in certifying the 10 USEC gaseous distribution plants which were previously 11 operated by DOE.
12 And we have a, if you like, a collegial role, 13 in DOE's clean-up of West Valley, where we give them 14 certain advice.
So, we are involved with the Department 15 of Energy in a number of areas.
16 But about, my recollection, the better part of 17 two years ago, a little more, questions began to arise as 18 to whether DOE should be externally regulated broadly.
19 Questions were raised in the Congress.
20 As a result of some of these interests, the 21 DOE created their Advisory Committee on External 22 Regulation of DOE Nuclear Safety.
23 They considered the merits of external 24 regulation, and provided a report in about December of 25 last year, and concluded that external regulation would, NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE.. N.W.
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in fact, be appropriate.
The detailed reasons appear in 2
the issue paper, or they are summarized in the issue 3
paper.
i 4
Among the alternative regulators that the i
5 committee considered were the Defense Nuclear Facilities s
4 6
Safety Board, which already has a role at the DOE, and the I
j 7
Nuclear-Regulatory Commission.
i 8
Recognizing that this was an issue, 9
recognizing the possibility that, nt soae point, Congress e
10 might act to give us this kind of responsibility, or a 2
1 1
11 portion of it, it seemed very appropriate, as a part of i.
12 our strategic assessment process, to examine whether or 13 not NRC would wish to regulate DOE, given the opportunity, 14 would wish not to, or would wish for something else.
15 Among the factors that we have considered in 16 this decision process would be two alternatives, and I 17 think we are coing to have one alternative or the other.
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18 In fact, I'm going to argue one alternative we have right 3
19 now.
J
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20 One would be that Congress could approve broad I
{
21 regulation of DOE by the Nuclear Regulatory Commission.
i 22 The other would be that we would regulate DOE 4"
23 increasingly, on an incremental basis.
And this is 24 happening.
25 Within the last few years, as I mentioned NEAL R. GROSS COURT REFORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE., N.W.
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earlier, we have been given responsibility for the gaseoua 2
distribution plants.
3 We are currently working with DOE to provide 4
them with advice on their clean-up of the Hanford tanks.
5 And, in a variety of other areas, we are considering 6
whether or not we would be more actively involved with i
7 DOE.
8 So, it would be my expectation that, even if 9
Congress were not to legislate broad responsibility, that 10 we will be given opportunities, perhaps direction, on an 11 incremental basis, to take on additional responsibility i
12 over DOE facilities.
13 That, if we were to take on the whole job,
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14 would be big.
DOE has over 3,500 nuclear facilities, j
15 depending on how you define them.
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16 If we were to take them on, our best estimates 17 in the paper, should we take on all of the external work 18 that the DOE committee would have an external agency take 19 on.
Not necessarily the NRC.
20 But, should we do that, our best estimate is 21 that it would take somewhere between 1,100 and 1,600 22 additional staff to regulate DOE in the way in which we 23 now regulate commercial reactors and materials.
Our 24 budget would have to increase by something like 150 to 200 25 million dollars.
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1 Now, to offer perspective on that, right now, i
2 we have about 3,000 people working for the NRC.
Our 3
current budget is about 475 million dollars.
So, you can 4
see what a dramatic increase this would be, to the Agency, 5
were it to occur.
6 And that raises a lot of questions.
How would 7
we divvy up the work?
How would we avoid being spread too 8
thin?
These are considered, again, in the issue paper.
9 Another question that we would want to deal 10 with, if we were to regulate DOE broadly, or, perhaps more 11 Importantly, if we were to regulate DOE on an incremental 12 basis, is that I think, as most of you know, we are 13 required to cover, recover our budget.
14 We are a full fee recovery agency, so we 1
15 recover the budget by fees for licensing, by fees for 16 inspection.
How would we best go about doing that?
17 Because, if we were to do it incrementally, 18 there is the possibility we would get additional work, but i
19 it might be more complex to recover the resources, with 20 the possibility that the NRC might find itself stressed to 21 take the existing resources, and add, incrementally, 22 responsibility for DOE.
23 So these are some of the concerns that we had, 24 some of the key factors.
And, with that in mind, the 25 committee considered a variety of options.
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10 1
Now, you see four options on the slide.
I I
2 would note that we, in fact, have sub-options to many of 3
those.
And I'll sketch over them.
4 The first option, support broad responsibility 5
for NRC regulation of DOE has several sub-options.
- One, 1
6 we could simply support that responsibility as described 7
by the DOE external committee -- excuse me.
The Advisory i
8 Cbmmittee on External Regulation.
9 That particular method of regulating DOE would 10 be somewhat different than the version that NRC now has, 11 dealing with commercial facilities.
)
12 Our relationships with other agencies is 13 somewhat different.
The External Advisory Committee would 14 have us regulate such things as NARM, which we do not now 15 regulate.
i 9
16 So that suggests, as a possibility, a sub-17 option, taking on broad responsibility, where we would 18 take on the responsibility, but use the same 19 responsibilities which we now have through the commercial 20 industry.
21 If -- one advantage, if no other, is that 22 there would at least be consistency between NRC's 23 regulation and its relationship with other agencies, 24 across the spectrum of its responsibilities under that 25 option.
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11 A third alternative under that option would be 1
2 to try to improve a bit on where we are now.
For example, 3
many of you in this room are probably aware of some of the 4
frustrations that the public, the licensees, and the 5
agencies have had, in dealing with the subject of mixed 6
waste, with EPA.
7 If we were to take on these responsibilities, it might be good to regulate DOE in such a way that we and 8
9 the EPA come up with a more workable division of 10 responsibility than what we now have for commercial 11 facilities.
12 Another alternative would be that we could 3
13 take on broad responsibility for regulating DOE, but only 14 regulate certain types of facilities.
15 For example, the NRC could limit its 16 regulation to non-defense facilities.
This could have the 17 advantage of avoiding our injecting comparisons of 18 national defense and public health and safety in some of 19 our regulatory decisions.
20 Another alternative would be we could regulate 21 those things which are very similar to those which we 22 regulate right now.
23 As we -- as you can see in the issue paper, 24 there are descriptions of DOE facilities.
Many of those 25 are the same things that we regulate commercially, or very NEAL R. GROSS COURT REPORTERS AND TRANSCRBERS 1323 RHoDE ISLAND AVE., N.W.
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close to them.
But there are some, such as NAPJ4, which we i
2 do not now regulate.
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Another possibility would be that we would 4
take on all responsibilities, with the exception of 5
environmental restoration.
One question to be asked is, 6
given that DOE is doing environmental restoration for a l
7 number of its sites, what should the NRC role be?
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8 Should we be active in that, or should we l
9 recognize that it would be a better responsibility for j
10 EPA?
Would it be a good use of our resources and DOE's 11 time?
l 12 The third alternative is we could simply 13 oppose being given the additional responsibility.
I I
recognize any of these decisions would be positions for 14 l
15 the Agency to take.
Obviously, whatever decision Congress l
l 16 might make, we will certainly carry out to the best of our i
17 ability.
18 But we could decide we not want the additional 19 responsibility.
We could argue that, for us to properly 20 protect public health and safety from commercial nuclear 1
21 facilities, be they reactors or materials facilities, we 1
22 need to focus our management attention and our resources 23 on those alone, and it would be inappropriate for us to 24 expand our responsibility.
25 We could even say that we. don't want any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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additional responsibility.
That what we have now is 2
enough, and that we should not expand, even on an i
3 incremental basis, what our current responsibilities for l
4 DOE facilities are.
5 Finally, we could take no position on broad l
6 NRC responsibility.
We could note that DOE is continuing 7
to wrestle with the idea.
We could note that Congress is 8
g'oing to make the final decision.
9 We can position ourselves to speak to it, if 10 asked, but not take a position at this time.
That it 11 would simply be better for the Agency to be prepared to 12 discuss the subject when asked.
13 Those options were provided to the Commission.
14 As you've seen with other sets of options today, they were 15 intended to provide a broad range of alternatives for the 16 Commission to consider.
j 17 And, as you can see on the next slide, the 18 Commission's preliminary view is that it would not take a 19 position.
We would neither encourage nor oppose 20 legislation that would give us broader authority over DOE 21 facilities.
22 The Commission did note one or two things in 23 their preliminary review.
They believe that, if we were 24 given adequate resources and a reasonable timetable to 25 develop them, that we could provide adequate regulatory NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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oversight over DOE, if asked.
t 2
And, in the next viewgraph, we note that, were 3
we given that kind of oversight, so that we could have the 4
time to develop proper programs, we'd very much like to 5
have it, it given to us on as incremental basis, and that 4
I 6
we'd have some methodology or type of prioritization 1
7 available, so that we could best decide what would be the I
i 8
m'ost important thing to do, as we.take on regulatory 9
responsibility.
i 10 What should we deal with first?
Where could 11 we be most cost effective?
Where we could, could we most 12 constructively help health and safety?
{
13 That's the issue paper, very briefly, and the 14 Commission's preliminary views.
And I'd like now to turn 4
15 it back over to Chip, to hear what you think.
i 16 MR. CAMERON:
Okay.
Thank you very much, Mal.
17 There's a lot of things to consider, as you can see from, 18 from Mal's presentation on this particular issue.
Not 19 only in terms of the options, but also in terms of the 20 sub-options on this particular paper.
21.
And I guess I would just open it up to, to 22 anyone who wants to make a lead-off comment here, either 23 on the reasonableness of the preliminary. option, are there 1
24 any downsides to that, or, or anything.
Ruth, do you want j
25 to, to make a statement?
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MS. MCBURNEY:
I'm Ruth McBurney, from Texas 2
Department of Health. I'm here representing the Board of Directors of the Conference of Radiation Control Program 3
4 Director.
5 The CRCPD is a national organization dedicated 6
to rac:iation protection that is made up of personnel from 7
state, district, and territorial radiation control program l
8 throughout the country.
That is, non-agreement states and 9
agreement states.
So, we're pretty comprehensive in, in 10 the, the collective voice of all the state and local 11 programs.
I 12 We have established, within the Conference of 13 Radiation Control Program Directors, a committee that is 1
14 made up of state radiation control personnel in the states 15 in which the Department of Energy sites are located, and 16 they are working to develop some positions on how DOE i
17 oversight is to, could be accomplished, working with the 18 Department of Energy and some of the other federal 19 agencies as well.
20 As far as our comments on this issue, we noted 21 that there are several aspects of the issue that were not, 22 that we felt were not adequately addressed in the 23 document.
24 The first of which was that the description of 25 the Department of Energy facilities or programs omits NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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nuclear weapons assembly and disassembly facilities.
And i
2 we felt that they should at least be described there.
3 The concept of a waiver of sovereign immunity 4
for federal facilities, and what impact that would have on l
5 the workload of the NRC versus that which states could i
6 assume.
7 This is really clear in the discussion, I
8 e'sp%.taly like accelerators, where the states have all 9
the regulatory expertise, and NRC has much less.
10 Regarding a funding mechanism of how this 11 might could be accomplished, the NRC must find a way to 12 assure that the costs associated with the regulation of 13 DOE are not treated as overhead, and distributed among its j
14 other licensees.
15 We recommend that NRC seek amendment of the l
i 16 Atomic Energy Act, to allow for a funding process similar 17 to that used for U.S. Enrichment, or to be able to charge 18 fees to the federal agencies it regulates.
i 19 DOE must should be regulated just as other 20 licensees, including the payment of fees.
This would also 21 help remove the idea that NRC would have to develop some 22 new and different program for the regulation of DOE.
i The CRCPD Board of Directors supports the l
23 s
24 inclusion of decontamination as a regulated activity.
If 25 NRC intends to not regulate decontamination, there needs j
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1 to be a clear justification for that.
l 2
Supporters of the concept of the NRC 3
regulation of, of DOE point to NRC's high standards as an
)
4 advantage, rather than an obstacle.
If NRC standards were 5
not high, we doubt that there would be much incentive to 6
initiate the oversight process.
7 In addition, allowing development of different 8
standards for the DOE facilities would only dilute the 9
process, and cause frustration among other NRC licensees 10 being held to different standards.
11 Regarding the option, based on the record of 12 past omissions, the Department of Energy should not 13 regulate itself.
14 The options and the direction-setting issues 15 include regulation by the Defense Nuclear Facility Safety 16 Board, or the NRC.
17 Of the two agencies, only NRC has the 18 experience and resources necessary to enable a transfer 19 and implementation of regulatory responsibility to an 20 outside organization.
21 We believe NRC should pursue adoption of the 22 advisory committee recommendation.
That's the Advisory 23 Committee on External Regulation.
24 Incorporation with agencies with adjacent 25 responsibilities.
NRC should wors with the state NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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radiation control programs to develop a model proposal, 1
2 per sub-option 1B.
3
~
.A plan for the NRC to subsume the Defense 4
Nuclear Facilities Safety Board into its operation, during 1
i 5
the transition from self-regulation to NRC regulation, I
y 6
could be developed, along with a determination of which 7
facilities and operations were going to be regulated by 1
8 N'RC or by the states.
4 9
And this could be done by focussing on main 10 concepts developed by the committee.
That is, that DOE 11 should be regulated like other nuclear facilities.
i s
12 DOE has signified its commitment to external 13 oversight, Congress has indicated in providing 14 legislation, host states are supportive of external i
4 15 oversight, and affected stakeholders have petitioned the 16 federal government to resolve this issue.
Thank you.
i 17 MR. CAMERON:
Thank you, Ruth.
Mal, do you 18 have follow-up questions for, for Ruth on that?
j 19 DEPUTY DIRECTOR KNAPP:
I don't think I do, at 4
4 20 this time.
I'd just like to note for the record that 4
a 21 there was a meeting yesterday where a number of agreement 4
22 state representatives joined us.
23 We got their suggestions, and we had a very i
24 constructive discussion.
And a summary of that meeting 25 and the written comments will be part of the public i
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1 record.
2 MR. CAMERON:
Okay.
That's a, that's a good 3
point.
That will be part of the public record, that 4
session.
Okay.
5 DEPUTY DIRECTOR KNAPP:
Okay.
So, given that, t
6 I believe I understand Ruth's comments.
Thank you very 7-much, and we will consider them.
i B
MR. CAMERON:
And I guess I would just ask I
9 Ruth, if you
- if I could ask you to clarify the one 10 point.
In terms of -- you talked about the waiver of 11 sovereign immunity.
I 12 In terms of the conference position, is it 13 advocating that, if the NRC was given authority for a
)
[
14 broad scope of DOE facilities, that we should, should j
15 operate our regulatory framework in the same way that we 16 operate the regulatory framework for commercial l
17 facilities?
18 In other words, the agreement states should be l
19 allowed to regulate the DOE facilities that might fit, l
20 might correspond to the present types of facilities that 21 we have the states regulate?
)
22 MS. MCBURNEY:
I believe that part of that is i
23 right.
Part of it would be to allow those states that 24 have facilities like accelerators, like the, the DOE labs, 1
j 25 to regulate those.
And not so much for the states to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISUU4D AVE., N W.
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assume, agreement states, oversight on those.
2 MR. CAMERON:
So we wouldn't necessarily have 3
to follow the agreement state model?
4 MS. MCBURNEY:
No.
y 5
MR. CAMERON:
Okay.
And I guess that what, 6
what the Conference is recommending is that the Commission 7
aggressively pursue taking over the regulation of DOE 8
fhcilities?
9 MS. MCBURNEY:
Right.
10 MR. CAMERON:
In other words' 1B, rather than 11 just sort of sitting back and waiting to, to see what 12
$1appens?
13 MS. MCBURNEY:
That's correct.
14 MR. CAMERON:
Okay.
Thank you.
Do we have 15 some comments on, on the Commission pursuing option 1B7 16 Yes?
17 MR. CRITES:
That's the takeover option?
18 MR. CAMERON:
Yes, I hate to say.
Takeover.
19 I don't know.
I don't know if that sounds right.
But 20 yes.
21 MR. CRITES:
Bob Crites, Gaithersburg, 22 Maryland.
Yes.
I would support option 1, for NRC to 23 assume the responsibility for regulation of DOE.
24 And, although it was pointed out that there 25 are 3,500 DOE facilities, that's only about a tenth of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.
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i licensed facilities NRC now oversees.
2 It was pointed out in the option paper that 3
these facilities are located in 13 states.
However, the 4
NRC has a national presence, and, in 21 of the states, 5
provides all the regulation.
So I believe that NRC has 6
capability, has presence there, and can manage this 7
effort.
8 As to the resources, the ability to staff 9
this.
There are currently about 100, 120 full-time 10 employees in the Defense Nuclear Facilities Safety Board, 11 and DOE has its own staff, NEH, that has been providing 12 regulatory oversight, within the agency.
13 These staff would not be necessary, if the NRC 14 were to take over that responsibility, and could be 15 transferred to helping out this effort.
16 The final point that I would like to, to make 17 addresses the issue, or the concern about the priorities 18 of nuclear, or of national defense versus public safety.
19 And, if universities and medical installations 20 can meet NRC requirements, it's inconceivable to me that 21 DOE, with its resources and scientific backing, could not 22 do likewise.
23 MR. CAMERON:
Okay.
Thank you.
How do other 24 people feel about the NRC assuming responsibility for 25 external regulation of DOE facilities?
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22 1
And a related question to think about is what 2
are the downsides if the Commission pursues option four?
3 In other words, the more or less wait and see posture.
Is 4
there, are there dangers there?
Richard?
5 MR. RATLIFF:
Richard Ratliff, to clarify.
6 With the State of Texas, Texas State Department of Health, 7
but representing the organizational agreement states.
8 We've also submitted detailed comments at the 9
meeting yesterday, and will have follow-up comments.
But 10 we really believe that it's time for the DOE to not have 11 self-regulation, but have oversight.
12 Multiple of the agreement states, for the last 13 five years, have had cooperative agreements in place with 14 the Department of Energy, where we do enhanced i
15 environmental monitoring off-site, sometimes on-site, and i
16 we do emergency response planning.
I 17 I think one thing that, that may be lost at 18 the federal level many times is that, when you get to the i
19 agreement state level, the states are responsible, whether 20 it be an NRC-licensed reactor or a DOE facility, for the 21 protection of public health and safety of the citizens of 22 that state.
23 And so we do have emergency response 24 capabilities and environmental monitoring 25 responsibilities.
And so we do feel that NRC should move NEAd. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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23 1
into this arena.
2 We agree with the fact that, that the states 3
have been working in this area for years, that there 1-j 4
should be a program similar to the way EPA has worked the 5
hazardous waste program, where they_have delegated I
l 6
authority to states, and the state regulatory program 7-actually does the inspection of hazardous waste at DOE l
8 s'ites, including, in Texas, the PANTEX site, and the mixed i
3 9
waste that would be associated with nuclear weapons i
i 10 production or disassembly.
11 And we really do feel that the, the production j
12 and assembly facilities should be included, if NRC has 13 oversight.
i 14 As we all know, the, our President has entered
)
I 15 into treaties with the Russians to disarm, and, because of 16 this disa'rming, there are multiple warheads that~are being 17 disassembled, with an increasing number of, of what they 18 call pits, the center of the nuclear weapon, being store i
19 at PANTEX.
20 And I, and I think it's a successful program,
- 21. but we need to make sure that there is adequate oversight, 22 and the states have the resources to assist NRC, and that 23 this could really be a joint partnership, where we really 24 do work together for the, the good of not only the whole 25 nation, but the states and the people in the adjoining NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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- areas, i
2 Ruth basically covered all the other common i
3 areas, but we, we also agree, if the NRC waits the problem 4
just gets more and more unwieldy, and I think that, with 4
i 5
the expertise of all of the people concerned, we can bring 6
this to a better, satisfactory conclusion.
1 7
MR. CAMERON:
Thank you, Richard.
Again, the 8
soggestion is, is that the NRC would be well-served, 1
9 everyone would be well-served by being more pro-active on 10 this.
I mean, assuming that the NRC was'the best j
11 organization to, to take over external oversight.
e 12 !
Is the committee that, that Ruth mentioned --
13 that's a standing committee now, that the NRC, we would be
{-
14 able to work you on, on these issues?
i 15 (No audible response.)
l 16 She's shaking her head yes.
Okay.
Is, is, 4
i 17 would -- you know, there's the question of should DOE be 18 externally regulated, and there's the question of who 19-should do it.
l-l 20 Does, does anybody believe that DOE should, 2
t 21 should not be externally regulated?
Just to get that off 22 the table.
i a
23 (No response.)
1 1
24 Okay.
No one stepped forward on, on that one.
l 25 Mal, do you have any things that you would specifically 4
4 NEAL R. GROSS I
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25 l
1 like to, to find out from people?
2 DEPUTY DIRECTOR KNAPP:
I'd be interested in 3
views on one particular subject.
This is, this relates 4
not only to this issue paper, but to others that are being 5
discussed.
It has to do with the regulation of mixed 6
waste.
7 As I mentioned earlier, a number of us have 8
s'ome frustrations with the overlapping responsibilities of i
9 NRC and DOE -- excuse me, and EPA.
Sorry about that.
I 10 don't which of those two agencies I would aggravate by 11 saying that.
12 (Laughter. )
13 But one of the alternatives, one of the sub-14 options here is that, if NRC and EPA were to have 15 responsibility for DOE, and if we were to regulate DOE's
.16 mixed waste, that a very simple solution would be to 17 determine if we have chemical -- let's talk about what 18 mixed waste is, for those of you that may not be familiar 19 with it.
20 It's waste which is, has hazards both because 21 it's radioactive and because it's chemically toxic.
- Now, 22 one of the proposals made by the issue paper would be 23 that, given that both hazards are present, we would 24 attempt to determine which was the controlling hazard.
25 In many of these cases, the chemical toxicity NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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26 1
could far outweigh the radioactive toxicity, or the other
! [rway around, i
3 Once we had determined which hazard was 4
controlling in mixed waste, we would then simply have the i
5 agency that has the lead for tha. hazard deal with
-l 6
disposal of that waste.
1 l
7 Thus, for radioactive, it would fall to NRC.
8 I'f it were principally chemically toxic, it would fall to 9
EPA.
It's a simple way of making life a lot simpler.
We 10 have worked for years to try to resolve the mixed waste 11 issue in other ways.
12 I would be interested whether anyone has any 13 comments on whether that particular aspect of the issue 14 paper is good, bad, or indifferent.
I did hear a comment 15 yesterday from the states, that they think that that could 16 be workable.
I'd like to hear any other ones.
17 MR. CAMERON:
Good.
Do we have a response for 18 Mal on that issue, from anyone, the mixed waste issue?
19 Judy?
20 MS. JOHNSRUD:
I have a question.
I have a 21, question.
Can we anticipate a substantial increase in the 22 quantities of mixed waste, resulting from decommissioning 23 clean-up activities?
DOE's activities, not to mention the 24 commercial realm.
25 DEPUTY DIRECTOR KNAPP:
I don't know that I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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27 5
1 real comfortable answering that question.
I'd have to 2
deal with, with hearsay.
I understand there is a fair a
3 amount of mixed waste that DOE has responsibility for, but I
4 I honestly don't know how much.
5 If there are any NRC staff in the audience who 6
can give some sort of a quantitative, or somewhat i
7 quantitative answer to the question, I'd be happy to hear 8
f'orm them.
9 MR. CAMERON:
Anybody else have a response or 10 information on the mixed waste issue, for Dr. Johnsrud?
11 Yes?
And please state your name, Ed, and affiliation.
12 MR. RHINGHE:
Edward Rhinghe, from the 13 Department of Energy.
Even though that's not my i
14 particular area of expertise, I feel confident in giving i
15 you a one word answer.
Yes.
There will be,a large 16 increase in the amount of mixed waste generated as a 17 result of all our clean-up activities.
18 MR. CAMERON:
And can you tell us why that j
19 would be?
20 MR. RHINGHE:
Well, for example, if you look 4
21 at the, the Hanford tank problems, and the problems there.
22 There are many areas where there is contamination in the 4
i 23 soil that is both radioactive and chemical, and there will 4
24 be -- and also, in disassembling a lot of our plants, they 25 have the same thing there currently.
i NEAL R. GROSS COURT REoORTERS AND TRANSCRIBERS 132' TlODE ISLAND AVE., N W.
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u 28
]
1 The buildings are sitting there.
They're 2
contaminated with both hazardous and radioactive material.
T l
3 As those are torn down and cleaned up, they will generate 4
waste to be disposed of.
I 5
MR. CAMERON:
Okay.
Thank you, Ed.
Yes?
6 MS. FAIROBENT:
Lynne Fairobent.
Chip, I a
7-think one think one thing that bothers me, as I sit and
{
8 listen to all of this discussion, is the fact that we 4
9 continue to try and differentiate and make a difference 1
10 out of the risk associated with DOE type of activities and j
11 the risk associated with commercial type of activities.
l 12 The amount of mixed waste that may be 13 generated, whether DOE is externally regulated or 4
I' 14 continues under its current regulatory scheme, is no
)
j 15 different.
Okay.
1 16 That amount of waste, quantity-wise, hazard-17 wise is still going to be the same.
The only thing that 18 will change on that is th'e technologies employed during D 19
& D and remediation activity.
20 I think, in answer to Mal's question on the i
21 mixed waste, I guess my concern stems from the fact, 22 again, that, when you take a look at the risk, and you j
23 take a look at the hazards involved to the public around 24 any of these facilities, be it a commercial site or a DOE 25 facility, because of the split with the Atomic Energy NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N W.
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29 1
Commission, and DOE's self-regulation over the nuclear
{
2 aspects of their program.
3 Remember, EPA regulates the environmental.
4 DOE is not self-regulated in that sense.
And DOE, about 5
four years ago, made the commitment to go to external 6
regulation for OSHA, for non-nuclear safety hazards.
i 7
So we're talking about, really, who continues, i
8 o'r who should be regulating the nuclear aspects of it.
To l
9 the public, I think, that differentiation is not very 10 clear, especially if you're in the state'where you're co-11 located to a commercial facility and a DOE reservation.
12 The off-site releases are not differentiated 13 if they come from a DOE facility or a commercial facility.
14 They don't look different out there.
And we continue, or
'.5 we have been continuing to perpetuate this split in, in 16 approach and pnilosophy.
17 And I think somebody earlier asked should we, 18 you know, what happens if we don't expedite taking on 19 responsibility.
I think we continue to propagate the 20 continuation of dual regulatory paths, let's say, in the 21 radiation area, and different philosophies.
)
i 22 A key _ example is 40 C.F.R.
193, which EPA's 23 been trying to promulgate for years, that is a low-level i
24 waste standard.
25 If you go back and look at it now, I believe NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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the current draft would not apply to commarcial 2
facilities, but continues to apply to DOE facilities.
The i
I 3
hazards are basically the same.
4 So we continue, within DOE, as we revamp its i
5 regulatory pro ess, either in the transitioning from DOE 6
orders and responses to DNFSB recommendations, or Price t
7 Anderson Amendment rules.
8 We're just continuing another set of 9
regulations.
If one set is good enough on the commercial i
f 10 side, and the material is the same, why is that set not 4
11 good across the board?
i i
12 MR. CAMERON:
Okay.
Thank you, Lynne.
I 3
f l
1 4
13 think that's a, a good point on what may be one of the 14 downsides of option four.
15 It also brir.gs urs another issue, which is we j
16 tried to identify a number of factors in the paper about 17 why it might be -- what are some of the difficulties of i
18 NRC taking over, assuming regulatory authority over DOE, i
19 and Mal mentioned staff, cost, there's type of staff that j
20 might be needed.
21 I think your comment shows that there may be 22 no differences, in terms of regulating DOE facilities, in 23 some respects, from commercial facilities.
l 24 But I guess I would like to ask all of you 25 have we identified all of the factors that should be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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31 1
considered in external regulation of, of DOE?
National l
2 security, whatever.
3 And, among those factors, are there, is there 4
any factor that would influence the decision of who should i
i 5
be the external regulator of DOE?
Yes?
6 MS. JERRILL:
Thank you.
My name is Lisa 7
Jerrill, and I work for the United States Enrichment 8
Corporation, and we operate the gaseous diffusion plants.
l 9
And we're just going through this process, where NRC is 10 taking over regulatory authority from DOE.
11 And we're in a transition phase right now, and 12 that's one thing you haven't mentioned, that there is 13 going to be a phase where the facility is going to be 14 dually regulated.
15 And that has been very problematic for the 16 company, and for he plants themselves that are continuing 17 operation.
18 So that's something, I think, that should be 19 factored in as a, something you should plan for, this 20 transition phase, and how the plants have to go to two 21 regulators, and get them to agree on a tech spec change, i
22 or NKTSR.
It's very problematic.
23 Secondly, the point about holding these 24 facilities to the same standards as the utilities you now i
i 25 regulate.
l l
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32 1
I also think the Agency has to take into 2
consideration that these are facilities that have operated 3
for 40, or odd years, or however many odd years, under 4
DOE.
And, in many cases, design criteria doesn't exist, 5
let alone can't be found, somewhere in Oak Ridge.
6 So, I mean, that has to be taken under 7
consideration.
That there are standards that should be 8
s'e t, and goals that should be set for these facilities to 9
meet, but that, the minute they are under NRC 10 jurisdiction, they're, they can't, they can't possibly 11 meet the same standards-that a facility that has started 12 with the NRC, and gotten their license from the VRC is i
13 held to.
14 MR. CAMERON:
Thank you.
That's a good point.
15 I believe that point is something that, that we haven't --
16 have given some though to.
17 DEPUTY DIRECTOR KNAPP:
We have given some 18 hought to it, but I'm pleased it come up again.
I agree 19 with you on both your points.
20 MR. CAMERON:
Okay.
Anybody else out there 21 want to make a comment on this particular issues paper?
22 Did you want to make a comment, sir?
Oh, good.
Come on 23 out, or up here, if I can make it a little easier.
{
24 (Asides.)
25 MR. MCDOUGAL:
My name is Rob McDougal, and I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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work for SAIC, which is a contractor for DOE, and their 2
environmental management program.
3 3
One of the things that struck me was, from 4
reading the legislation that died in the recently i
5 concluded session of Congress, to create an interim spent i
6 fuel storage program.
7 There was a provision there clarifying that i
N'C regulatory jurisdiction would continue after DOE is 8
R l
9 required to take possession of the spent fuel from the 10 utilities, under the provisions of the Nuclear Waste l
11 Policy Act, January 31st, 1998 deadline.
12 I was wondering if anybody at NRC has thought l
13 about what the statutory basis is, for the survival of NRC i
14 regulatory jurisdiction, after DOE takes possession, as it i
15 is now required to by the federal appeals court ruling?
j 16 MR. CAMERON:
Does Larry want to handle that?
17 (Laughter.)
i 18 MR. CHANDLER:
I understand.
It's -- I'm not 19 sure the premise of your question is completely accurate.
20 I believe the court was speaking to the take title 21 provision that requires that the Department would take 22 title.
23 You need a mike.
24 MR. CHANDLER:
I said I'm not sure the premise 25 for the question is correct.
My understanding is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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Court of Appeals was addressing the take title provision, 1
g 2
which requires the Department of Energy to take title to 3
the spent fuel, but not actually possession of it.
4 So, it's unclear to me where possession would 5
remain.
It might actually remain in the possession, I J
6 suppose, of the licensed, currently licensed facility, j
i 7
which is subject to NRC licensing.
8 And, in that context, I could more readily 9
understand, understand the question.
We would have 10 authority over the facilities, and continue -- over the 11 fuel, to the extent it's being possessed by the current 12 licensee.
But I, I don't know.
I'm not that familiar 13 with it.
14 MR. MCDOUGAL:
If you assume that a utility 15 executive would probably want DOE to take possession and 16 title to the fuel, under the, under the provisions of the 17 Act, whi'ch I think they would probably have a financial 18 interest in doing, what -- I was just curious about what 19 the basis is for NRC regulating DOE, absent some I
[
20 legislative clarification of its authority.
21 Under the, as you know, under the Energy 22 Reorganization Act, the NRC has authority to regulate DOE 23 only with. respect to certain facilities that are 24 considered exceptions to the general structural feature of 25 the Reorganization Act.
But NRC would not be regulating NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND t.VE., N.W.
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35 1
DOE's Atomic Energy Defense activities, certainly.
2 MR. CHANDLER:
That's clear.
And part of the 3
premise of the, of the issue paper was the need for 4
legislative authority to do a lot of what we're speaking 5
of.
6 Clearly, under the Energy Reorganization Act, 7
I think there are four specific categories of facilities.
8 There's the High Level Waste Act, which gives you Yucca 9
Mountain.
Beyond that, you would need specific 10 legislation to deal with it.
11 But I think the first part of your question is 12 right.
I'm sure the utilities would love DOE.to take both 13 title and possession, in the way that you're saying.
14 MR. MCDOUGAL:
So, do I understand correctly 15 that it's your view that, without, absent congressional 16 action to clarify its statutory authority, that you, the 17 NRC corporately, is presuming that there is a significant 18 jurisdictional question about the continuation of its 19 regulatory jurisdiction over what started out as licensed 20 material 21 MR. CHANDLER:
You're, you're asking a very 22 large question over there.
I'm not prepared to answer it 23 that broadly.
24 MR. CAMERON:
Would you like to sign a 25 statement?
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36 1
(Laughter.)
2 MR. CHANDLER:
I've lost my voice again.
3 MR. CAMERON:
That issue, I think, is also 4
relevant to the high level waste spent fuel storage paper 5
that's going to be discussed tomorrow, and perhaps we'll 6
be better prepared to, to discuss that particular issue.
7 Before we end, we heard a number of people 8
s'upport a more planned, pro-active, whatever you want to 9
call it, approach to, to this particular issue.
10 Is there anybody else -- does anybody out 11 there who wants to speak to the Commission's preliminary 12 choice of option, about take no position?
Yes?
13 MS. JERRILL:
.I'm not sure on the timing on l
14 what, when you said take l'o position.
Do you mean take no 15 position now, or take no po ition even after. Congress says 16 go ahead and do it?
17 (Laughter.)
18 For instance, I mean, there are a lot of 19 people out there taking positions, and I would just think 20 it would be, it behooves the industry for the regulatory l
21, body to take a position.
I know somebody successfully now l
i 22 has passed, through one of the houses, a change to the 23 Act, to mandate that the Paducah guards have guns.
24 My God, they're changing the Act so that one 25 set of guards has guns, and where -- I wonder where the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVE., N.W.
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~. _
37 1
NRC was there, let alone something like this.
I just 1
2 can't believe you wouldn't take a position.
3 MR. CAMERON:
Mal?
4 4
(Laughter. )
5 DEPUTY DIRECTOR KNAPP:
Without, without going i
6 into detail, in a number of measures, including security, 7
the NRC is aware of pending legislation, and does take 8
p'ositions.
That does not necessarily mean that our views 9
carry the day with Congress.
10 With respect to whether we should take a 11 position, on overall regulation of DOE, if you like, 12 that's, that's what's on the floor right now.
13 There are arguments that would be that perhaps i
14 we would be muddying the waters, and that the better thing 15 to do, from a national perspective, is to take no 16 position, which is certainly one possibility, and 17 obviously that's the Commission's preliminary view is i
j 18 that they would not take a position.
l 19 But I'm, what I'm hearing today is that the
[
20 comments we've received are that we should take a 21 position, that we should seek broad responsibility for 22 regulating DOE, and I think, listening to Chip's queries, 23 did not hear people commenting in favor of the present 24 preliminary view.
25 MR. CAMERON:
Yes.
It seems that we've heard NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.
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a number of comments on the downsides of option four, and i
2 a number of comments in support of, of option one.
3 Now, of course, there are plenty of f
4 4
opportunities, by the November comment close date, for 5
people to offer comments contra to this in writing, or e-6 mail, and we would encourage you to, not to do, file 7
comments contra to this, but to, to comment on it.
i 8
But anybody else, before we go on, who wants 9
to state a position on, on the option issue?
I 10 (No response.)
11 Okay.
Well, good.
Mal, are you ready to, te 12 discuss the agreement state issue?
)
i j
13 DEPUTY DIRECTOR KNAPP:
All right.
The second i
i 14 issue paper for this afternoon's session is direction 15 setting issue number four that deals with our relationship 4
16 with agreement states, and the particular issue is what 17 should be our strategy regarding states becoming and 18 remaining agreement states.
19 And I'd like to go right ahead to some of the 20 key factors that we think, we have in the paper as items 21 of concern.
I 22 There are many agreement state i
23 representatives in the audience, but, for those of_you i
24 that are not, you might like to know that agreement states i
25 are responsible for approximately 70 percent of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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39 1
materials licensees in the country today.
2 The NRC licenses about 6,500 material users 3
with specific licenses.
The agreement sthtes have around 4
15,000.
The NRC has about 35,000 general licensees.
The i
5 agreement states handle about 100,000.
l 6
Of the 50 states,.29 are presently agreement
+
7 states, and four states are in the process of seeking, or 8
becoming agreement states.
Others may continue to do so.
4 9
with these things in mind, it's fairly clear s
10 what the first bullet is.
The number of our licensees is t
11 expected to decline as more states become agreement l
12 states.
13 And here I'm going to give a little bit into j
J l
14 the overlap between this issue paper and the next one, 15 which is the NRC's materials program.
I would expect some 16-of the comments we receive on this paper will overlap with 17 the next, and please feel free to do so.
These papers are 18 closely linked.
19 Clearly, as the number of agreements states 20 increases, the number of materials licensees with the NRC 21 will decrease.
This will have an impact on our materials 22 program, and the direction it should take.
23 One of the concerns that we have is the NRC's 24 method of funding.
The Omnibus Budget Reconciliation 25 Action of 1990.
That may be Act.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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40 1
OBRA, as we frequently refer to it, makes us a-2 full fee recovery agency.
This means that our licensees 3
pay for the things that we do, although, in some cases, i
4 the licensees may not receive the direct benefit for our 5
actions.
6 A question to be asked is what should be our i
7 relationship with agreement states?
Recognizing agreement i
8 states licensees, in general, would not pay money to the i
9 NRC.
When I say in general, there are certain 10 circumstances in which they do.
11 We also recognize that, as we've said in a 1
4 12 couple of other issue papers today, we are coming under 13 pressure to decrease the Agency's budget, and this would 1
14 mean that we should reduce the amount of financial support 15 that we provide to agreement states.
16 To be a little more specific, right now, we 1
n 17 spend in the neighborhood of about a million dollars a 1
18 year to pay for the training that agreement state staff 19 receive, and the travel that they take to get to that 20 training.
i I
21 One could argue on both sides of whether that 22 sort of funding should be continued, and it's a 23 significant issue to the Agency and to the states, so we 24 look for comments in that area.
25 Finally, we recognize that, as was mentioned i
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. ~
~. - -
-- - - ~.
.e 41 1
earlier, when the state becomes an agreement states, wa j
2 relinquish our regulatory authority to that state, but we 3
still have a remaining responsibility to oversee an i
4 agreement state program, and oversee agreement states i
5 through, currently, the IMPEP process.
3 6
With these factors in mind, we came up with a 7
number of options.
This is what I think a couple of folks 8
ift the agreement states refer to as an extremely broad set 9
of options.
10 (Laughter.)
?
11 Turn the agreement states program over to the
}
12 Environmental Protection Agenc;'.
Why would we want to do 13 that?
Well -- oh, I'm sorry.
I didn't mean to quote you 14 directly, Ruth, but.
I 15 (Laughter.)
16 The fact is that EPA has an authorized states 17 program, which, in some ways, resembles the NRC's 18 agreement states program.
i l
l 19 Now, while EPA focusses on the environment, 20 and does not necessarily focus on public health and 21 safety, or worker health and safety, the fact is, there is 22 an existing program in place at the federal level.
23 And one can argue that, in the interest of 24 effective and efficient regulation, that perhaps states l
25 would prefer to be dealing with one federal agency at a i
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42 1
time, in an agreement authorized status, rather than two.
1
^
2 Another option would be to strongly encourage 3
states to become agreement states.
This is simply a 3
4 recognition that the process does appear to be going in i
5 that direction.
More states are becoming agreement i
6 states.
l 7
Perhaps we should try to come up with a way to 8
g'et as many states to be agreement states as possible, and 9
couple this with appropriate change in out materials 4
10 program, which might somehow phase it out, or limit it, or i
11 change the NRC's entire role from being in materials as 12 much as a regulator, as it might a guide, a leader, a 13 coordinator of the agreement state programs.
14 Another alternative would be to continue the 15 current agreement states program, including adopting the 1
l
~
16 current initiatives.
17 We could also, as another alternative, treat 18 the agreement states more as co-regulators.
Another way 19 of looking at that would be that we would have a less, 20 shall we say, paternalistic role of the NRC, and we would 21 treat the agreement states much more as equals.
22 Again, for those of you that are not familiar 23 with the process, we do have an oversight responsibility, 24 yet, at the same time, we recognize that agreement states 25 have a principal role, they are regulators.
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Certain agreement states have very large 2
programs.
That a partnership is certainly a very 3
reasonable way to proceed.
This option has, as a part of 4
the partnership, that our funding of agreement state 5
programming would not continue.
6 And I'd like to digress a second.
In all of 7-the options that you see, in the materials papers and all 8
df the issue papers, they are not meant to be cast in 9
concrete.
10 We drew these things broadly, to give folks a 11 chance to see what they look like.
An option, by itself, 12 is not necessarily an only option, and variations on 13 options are being considered.
14 So, as you talk to us today, particularly on i
15 this paper, there may be aspects of an option, such as 1
16 having co-regulators or partners among the agreement 17 states, that some will favor, but another facet of that 18 option, such as not paying for agreement state training l
19 and travel, could be a part that you would not like.
1 20 And these are certainly not intended to be an i
21 irrevocable package, and comments, that you may like part 1
l 22 of an option but not the whole option will be very l
1 23 welcome.
i 24 Last but not least, we could go, if you like, 25 all the way.
Devolve regulation of AEA materials to the l
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i states.
Arguably, when we began to learn about nuclear t
2 materials, a half a century ago, we had a great deal to 3
learn.
4 Now, we know a lot more.
We have a pretty 5
good idea of what the hazards are that are associated with j
2 6
many materials.
7 States are already doing a good job of i
1 4
1 8
regulating a number of aspects of safety.
They regulate 9
NARM today.
Is it possible that we should consider that I
10 current AEA nuclear materials could also~be turned over to 2
1 11 the states?
Would that be a reasonable solution?
12 So, those are some of the options that we r
13 considered.
As I said, it is a very broad set, and 14 intended to provoke thinking.
j 15
.The Commission's preliminary views are that i
16 they would continue the current program, including 17 adopting the current initiatives.
They would encourage 18 more states to become agreement states, but they would not 19 use tangible or monetary incentives.
L l
20 Instead, they would use intangible incentives, 21 trying to strengthen our co-regulator partnership role.
22 They are considering providing seed money to states about 23 to become agreement states.
i j
24 The idea here is that a state considering 25 becoming an agreement state needs to develop programs, NEAL R. GROSS COURT REPORTERS AND TRANSCR18ERS i
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needs to develop regulations, procedures.
Perhaps seed 2
money could be of an asset to some of these states, to 3
become agreement states.
4 And, as a possible compromise with respect to 5
training, provide training to agreement states, without 6
charge, on a space available basis, and funding and travel 7
-- funding for travel would be borne by the agreement 8
s'tates.
9 This is an area where the Commission 10 particularly seeks comment, and as -- I think we have one 11 more slide to go.
No?
12 (No audible response.)
13 Well, if we had one more slide, here's what it 14 would say, and I think it's in your handouts.
We 15 particularly want comment on whether we should fund 16 agreement state travel, training, and technical 17 assistance.
18 And we particularly want comment from 19 agreement states, non-agreement states, keeping licensees, 20 keeping' licensees to the NRC and keeping licensees to the 21 agreement states.
l 22 A lot of what you've just heard is a result of l
l 23 the constraints we are under with OBRA, the Budget 24 Reconciliation Act.
i 25 We would like very much to come up with a way NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.
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I 46 1
of dealing with this situation that is as fair as it can 2
be to licensees in both agreement states and non-agreement 3
states, and the agreement states themselves.
4 With that summary, I would like now, again, to 5
return it to Chip, and ask for your comments.
6 MR. CAMERON:
Thank you, Mal.
Steve?
7 MR. COLLINS:
You've already heard my comments 8
on option one.
9 MR. CAMERON:
Steve, can you repeat those in j
10 public?
I 11 (Laughter.)
12 MR. COLLINS:
You heard them.
The agreement 13 states should be treated as partners or co-regulators, in 14 the effort to protect the health and safety from radiation 15 in'the United States.
16 The statute which created the agreement states 17 program recognized the growth of the states, and their 18 eventual assumption of a co-regulator status.
The 19 majority of the states are now agreement states, and are 20 fully capable of participating with the NRC in determining 21 the shape of the program.
22 By the way, I'm Steve Collins, with Illinois 23 Department of Nuclear Safety, representing the 24 Organization of Agreement States.
25 In your options, only option four states that, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE N W.
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quote, "the Commission would recognize the experience that 2
lies within the agreement states."
This recognition 1
3 should occur within the NRC, regardless of the chosen 4
strategy option.
5 The NRC's assertion, under option four, that, 6
as a part of this recognition, agreement states should be 7
self-sustaining, and should require minimal support, in j
8 tfie form of subsidized training, amounts to saying that 9
the agreement states must pay the NRC to recognize the 10 contributions made by the agreement states that support 11 the NRC and its licensees.
The contributions are i
12 identified in the specific comment section below.
13 Option four has taken the spirit of 1
14 cooperation between agreement states and NRC, and reduced 15 it to a destructive game of tit for tat.
16 NRC's ideas presented in option four are in 17 direct contrast to the views recommended in other DSI's, l
i 18 where cooperation with professional societies, 19 international agencies, and licensees is stressed.
]
j 20 The term co-regulators, as described under 21 option four, appears inconsistent with the states' views 22 of the NRC-agreement state relationship.
23 We propose that the NRC transform its 24 traditional view of the NRC-agreement state relationship 25 into strategic partnering.
The relationship is less donor 4
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1 48 1
helping recipient.
The relationship would be more equal i
2 and cooperative.
3 This idea is taken directly from the last l
4 paragraph on page 13 of DSI 20, international activities.
5 Yet the NRC is willing to foster such healthy 6
relationships overseas.
They should also want to foster 7
equally healthy relationships with regulatory agencies in i
8 the United States.
l 9
Something that's in answer to your question of 10 what is missing from the DSI, from the discussions, is an 11 evaluation of the health and safety impacts for each 12 option should be included, as these impacts are the 13 primary reason for NRC's existence.
t 14 With the above in mind, the agreement states 15 favor continuation of certain programs developed in 16 partnership with the agreement states, and presented in 17 option three, especially the adequacy and capability 18 policy statement, as revised by the agreement states in 19 September, 1996, and the IMPEP.
20 This is the Commissioner, the Commission's 21 preliminary decision.
In addition, we recommend the NRC 22 recognize the many benefits received by the NRC and its 23 licensees from the states, and return the funding of 24 training, travel, and technical assistance.
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s 49 1
more states to b3come agreemant states, to recognize the 2
fact that the agreement states are regulatory partners 4-3 with the NRC, and seek appropriations for the functions 4
involving agreement states with assistance in the form or 4
testimony before congressional committees provided by 5
l 1
6 agreement states.
7 I have some specific comments now, that I I
B referred to earlier.
The many benefits the NRC and its
,l 9
licensees receive from the agreement states, without a
10 reimbursement, were conspicuously missing from this DSI, 11 resulting in an inaccurate representation of the benefits-12 cost situation.
13 In September of 1996, the Organization of 14 Agreement States passed a resolution, pertaining to l
15 training and funding, that summarizes the services and 16 benefits provided to the NRC and its licensees by the 4
17 agreement states.
2 18 The benefits include the agreement states 19 regulate all commercial, low' level radioactive waste 20 disposal facilities, and are in the process of licensing 21 all the new commercial, low level radioactive waste 22 disposal sites.
l 23 Although the NRC charges a supplemental fee 24 for waste disposal, and these revenues are not provided to 25 the agreement states, low level radioactive waste NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE N.W.
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e-1 facilities in agresm3nt states continue to receive wanto 2
from NRC licensees, as well as agreement state licensees.
l 3
The second one.
The agreement states respond 4
to incidents involving transportation of NRC-licensed 5
material within their jurisdictions, particularly those 6
involving interstate carriers.
7 The third one.
Many agreement states provide 8
sdlaries for their staff participating in NRC IMPEP 9
reviews of agreement states, and NRC regional offices.
10 The fourth.
The NRC has requested and 11 received agreement state staff lecturers at NRC-sponsored 12 training courses, without payment of salary for agreement t
13 state staff time.
j J
14 Five.
Agreement states develop many rules 5
15 that benefit the NRC, such as well logging and industrial 4
16 radiographer certification, without compensation from the 17 NRC.
18 Six.
The agreement states have conducted 19 surveys, and assisted in the removal of by-product
).
20 material-from facilities at the request of NRC.
21 Seven.
The agreement states are currently 22 investigating potentially contaminated sites for licensees 23 that the NRC possibly terminated inappropriately.
24 And the last one.
The states monitor the 25 environs of nuclear power plants and other nuclear fuel NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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o u
51 1
facilities licensed by the NRC, in order to confirm tha 2
validity of NRC licensees' environmental monitoring 1
3^
prcigrams, and to confirm that releases of radioactive 4
m/4terials to the environment are in compliance with j
5 effluent limits, with only partial compensation.
- Now, l
6 that's estimated to be about one third of the cost.
7 In addition, other considerations that have 8
b'een omitted from this DSI include the following three.
9 The NRC states that it requires a minimum of 500 to 1,000 l
i 10 licensees to have a viable NRC program.
l 4
)
11 Most agreement states have less than 500 l
12 licensees, and would remain viable programs even if NRC's
)
13 by-product material program ceased altogether.
The NRC l
14 would do the same amount of work on the regulations if i
i 15 there were no agreement states, or if there were 49.
16 An evaluation of the health and safety impacts 17 for each option should be included, as these impacts are 18 the primary reason for NRC's existence, as I said earlier.
I 19 There is no evidence that so-called tangible 1
20 incentives, or seed money, without continued support from i
21, NRC, would result in any new agreement states.
Funds 4
22 would be better spent on training, travel, and technical j
23 assistance to the existing agreement states.
24 While the Commission wants to encourage more 25 states to become agreement states through intangible l
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- - - ~
52 1
incentives, charging them for assistance is a tangible f
2 disincentive.
3 Continued funding would send a message that 4
the NRC recognizes that the NRC and its licensees benefit 5
from new states becoming agreement states, and the overall i
6 cost of such regulation, on a national basis, will be A
7 lowered, with additional agreement states.
i 8
The NRC should look more closely at program 9
areas such as low level waste rescarch, detailed data 10 collection, and analysis of operational data and events, 11 and support of international students for spending cuts 12 which would not likely reduced level of safety for the 13 public and workers.
14 We have specific comments on each option, if 15 those are desired later.
16 MR. CAMERON:
Thank you very much, Steve.
i 17 Mal, would you like to follow up with Steve on any of 18 that?
19 DEPUTY DIRECTOR KNAPP:
I did have two points, l
20 and I think I understood them from yesterday, but I think i
21 it might be worthwhile so that others interested in the 22 discussion could be aware of them.
23 I believe, when we talked about international 24 students, you were referring to international attendees at 25 our training classes, where states presently participate.
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Am I correct in that?
2 MR. COLLINS:
Yes.
3 DEPUTY DIRECTOR KNAPP:
Thank you.
- Second, 1
4 you mentioned yesterday what the states said was an 5
advantage to having the training programs that did not j
6 arise in the comments you just made, and, if you are in a 7-position to sort of summarize it again, it might be 8
worthwhile.
9 This was the point, I think, that was made.
l 10 That the advantage of having a program run by the NRC to 11 provide training would be the uniformity and perhaps the 12 independence associated with having all of the regulators, 13 NRC and agreement state, trained in approximately the same 14 way.
l 15 Perhaps you, or one of the other agreement j
16 state representatives might like to elaborate on that, the 17 basis -- or, for the benefit of the rest of the folks 18 here.
19 MR. COLLINS:
Yes.
One way of assuring that 20 the same level of protection is provided across the United 21, States, from the same types of uses of radioactive 22 material, is to ensure that, regardless of who the 23 employer is, that the people out there, at the grass roots J
24 level, you know, face on face contact with the licensees, 25 actually receive their training and instruction from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1
same people, in an environment where the students are 2
learning together, and sharing the benefits of their 3
experiences.
4 So that basically, when they come across i
5 situations that are similar, they're handled similarly, 6
and the applicable regulations get applied similarly.
i j
7 And, basically, the real spirit of what's compatible, that i
8 is, comparable application ends up coming through with 9
that.
)
4 10 And one of the other things is I referred 11 several times to benefits and the services NRC and its 2
]
12 licensees receive.
Typically, if there's a transportation 13 incident, something in interstate commerce is under NRC 4_
14 jurisdiction, not the states.
4 15 But, if it occurs in the states, we're not i
i 16 going to wait for NRC to fly somebody in, and it's really 17 good for NRC to have state people there that they know, 18 because those students were in their classes with their 4
i 19 own employees, that the level of training is something 4
i 20 they feel comfortable with, when we go out and handle i
21 incidents that involve material that are technically under 1
22 NRC jurisdiction, or under another federal agency 23 jurisdiction that NRC has an MOU with, to provide 24 assistance.
25 DEPUTY DIRECTOR KNAPP:
Thanks for the 1
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1 additional commsnts.
2 MR. CAMERON:
And I guess I'd have one i
3 question, or clarification for you, Steve.
You were 4
talking about the fourth option, which is, treats 5
agreement states as co-regulators.
l 6
And, at a minimum, I think you're saying that 7
it's, it's really overstated, in the sense that it implies i
8 t' hat the agreement states are not, are not co-regulators 9
now.
10 Given that, is there anything within that 11 option that, if you take it out of this context of the i
i 12 implication that agreement states are not co-regulators 13 now, are there, is there anything in there that could 14 profitably be applied to, to any of the options that, that i
15 you're supporting?
Or, should it just be scrapped 16 entirely?
.L 7 MR. COLLINS:
Well, as I stated, basically, we 18 are already your co-regulators or your partners, whether i
l 19 you 3'ke to recognize it or not.
We do recognize that NRC i
20 has a role, under the Atomic Energy Act, that is not l
l 21 provided to the agreement states.
That is, the oversight 22 of the agreement states.
l i
l 23 But that difference in our roles should not i
l' 24 result in our failure to recognize that, in most other i
25 respects, the agreement states have equal responsibilities t
j 1
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e.
56 i
1 and functions, and an even larger scope of sources of 2
radiation to regulate.
)
3 So, with that stated, most everything else in 4
option four is basically pretty good stuff.
?
5 MR. CAMERON:
Okay.
6 MR. COLLINS:
We don't have a problem with the a
1 7
rest of it.
I 8
MR. CAMERON:
Okay.
Thank you.
l
]
9 MR. COLLINS:
The -- we made very clear that 10 the training and stuff, and the funding of that is not f
11 really ties to recognition of the partners that we are.
J i
12 That we are, have been sharing with you our resources, and 1
13 services, and stuff from the beginning.
i 14 We specifically think that our agreement, 15 between our governor of these states and their 16 commissioners, in fact, pledges our best efforts to 17 cooperate and provide those services and things, without I
18 getting into this tit for tat, who pays for what kind of 19 thing.
20 And we think that the benefits you receive are 21 worth well over the one million dollars, or 1.1 million 22 dollars per year that's spent.
We think the states'
/
i 23 efforts on low level waste licensing alone are worth more 24 than that.
25 MR. CAMERON:
Okay.
Good.
Good.
Thank you.
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57 1
Thank you, Steve.
Let mm ask Mal.
Is it -- it seems lika 4
2 it's a fair characterization to say that the Commission's 3
preliminary option combines elements of options two, 4
three, and four.
Is that, is that correct?
5
(;o response.)
N 6
I guess the point I'm trying to get to is it 7
seems like this option, about giving the agreement state 8
program to another federal agency, or the fifth option, 9
about just basically giving the programs, program 10 completely to the states, are pretty much off the board, 11 at this point.
12 DEPUTY DIRECTOR KNAPP:
You're correct in 13 that.
I think I would -- my interpretation of the 14 Commission's words, and those of you that have them right 15 in front of you can do this just as well as I can, would 16 be that the real, the real focus of the Commission at this 17 point, a preliminary view, os to continue the current la program.
19 But -- and then they would encourage, with 20 intangible incentives, additional states to become 21 agreement states.
22 so, I -- yes.
I think it could be reasonable 23 to say it contains elements of the three in the middle, 24 but I think the principal focus is that they're.
25 MR. CAMERON:
Okay.
Well, given that, is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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1 there anyone out there who would like to comment on either 2
option one or option five?
I'd-just like to make sure 3
that we're not ignoring someone who, who feels that those, 4
those options might be the best way to go.
5 DEPUTY DIRECTOR KNAPP:
Chip, could I add just 6
another thought, as you look at these.
Someone that is l
l 7
strongly opposed'to one of the options, we want to hear 8
that two.
You don't necessarily have to favor.
9 MR. CAMERON:
Oh, that's right.
I J
10 (Laughter.)
11 I think we heard, aarlier, some, some 12 opposition to, to option one, at least, and I think we 13 have a reluctant comment, or perhaps, over here, on those.
14 But we're not, I'm not trying to -- I'm not looking for 15 people who just want to support those options, but I just 16 want to make sure that we have a discussion on this.
17 Judy?
18 MS. JOHNSRUD:
Yes.
When the SECY-95, was it 19 201, came out, years ago, a year ago, proposing to abolish 20 the low level waste division, I found myself in the rather 21 awkward position of supporting the NRC, around the low 22 level waste division of the NRC.
I gasped at the thought 23 that you might be wiped out.
24 But, with regard to the fifth option, I,
I 25 fully appreciate and concur that we need some baseline of NEAL R. GROSS COURT REPORTERS AND TRANSCREERS 1323 RHODE ISLAND AVE., N.W.
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l 59 r
1 standards that are uniform, throughout the nation.
But I l
2 think, increasingly, the states are seeing that they may 3
have clusters of pollutants of various kinds, that impact 4
upon their citizenry.
i 5
And the, the synergisms and the multiple j
i 6
source problems devolve back to the states, to deal with 7
those who may suffer health impact from a variety of 8
en'vironmental pollutants.
i 9
And it's for that reason that many of us in I
l 10 the environmental community are urging that the states be 11 authorized and permitted to set standards, radiation 12 standards, that may be more restrictive, but not less so, 1
l i
6 L
13 than those of the NRC.
l t
l 14 And this is in order to deal with the real 1
t 15 world problem of health damage that may result not only 16 from the radiation, but from that, or.perhaps from several 17 sources of radiation, within a given portion of a state.
18 It's a, in a sense, it's a very difficult 19 problem, and yet -- and I know some states want to go down 20 to the other end, and simply let go, but there, there 21 appear to be some needs for the ability to be more t
22 restrictive than the baseline federal standards.
23 It would give us uniformity, but would also 24 permit the particularity on the part of a state that 25 wished to protect its citizens better.
I l
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MR. CAMERON:
Okay.
Thank you.
Mal, do you 2
have a, any comment on that?
3 DEPUTY DIRECTOR KNAPP:
I just want to make 4
sure.
I think I interpret your comment well, but I just i
i 5
want to restate it.
With respect to the general concern 6
of regulation, it's your view that states should have an 7
opportunity _to be more restrictive than federal standards, 8
but not less.
9 To translate that into an application of 10 option five here, you would not favor devolving this to 11 the states, because that would essentially eliminate a 12 federal presence in this material?
13 MS.,
JOHNSRUD:
That's right.
And I think it 14 is, I think the situation is compounded by some states, 15 where administrations and legislatures are even more 16 determined to cut the budgets and the existence of 17 regulation.
So, it's -- we're in a difficult era.
18 DEPUTY DIRECTOR KNAPP:
Thank you.
19 MR. CAMERON:
Okay.
Thank you, Judy, and 20 thanks, Mal.
Cardelia?
21 MS. MAUPIN:
Hi.
Cardella Maupin, Office of 22 State Programs, NRC.
Hi, Judith.
I remember you from our 23 compatibility workshop, back in 1994.
We just sent out 24 revisions on our compatibility and adequacy policy that 25 we're looking at, and we did send you a copy.
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I 61 1
And, in looking at that, you should see that 1
'2 the states would be given, or we're envisioning to, in 3
that proposed finding, to give the states more flexibility 4
in dealing with the issues that you just mentioned.
5 On the other hand, in looking at those states 6
who want to use other legally binding measures to 7
implement requirements, we're also looking at using what a
we call the IMPEP program to make sure that the overall 9
protection of -- that the state is doing an overall 10 adequate job of protecting public health and safety, which 11 is the primary mission.
12 So, I would just encourage you to look at that 13 package.
I know it's very extensive, but that's what we 14 hope to get with those revisions, and that new policy 15 statement.
\\
16 MR. CAMERON:
Okay.
Thank you for that 17 information, Cardelia.
Roy?
18 MR. BROWN:
Roy Brown, with the Counsel on 19 Radionuclides and Radiopharmaceuticals.
CORAR member i
20 companies have fixed facilities, nuclear pharmacies, i
J 21 distribution facilities in all 50 states.
22 We obviously sell to hospitals and physicians 23 in all 50 states.
So, we deal quite a bit with NRC 24 licenses.
We have agreement states licenses.
We are 25 selling NARM products in NRC states.
We have a whole NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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variety of regulatory authorities, in doing really 2
everything in all 50 states.
1 3
One thing that we're disappointed that was not 4
addressed in this DSI was the issue of compatibility.
We 5
see there are quite a few problems with compatibility now, j
6 between the NRC and the agreement states.
But there's 1
7 also a problem with compatibility between agreement 8
states.
I 9
Even though the CRCPD has done a very good job 10 developing standards for states, the states that have 11 adopted them, they work very well, but the states that 12 have not adopted them create some problems for us.
13 We have problems everyday in transporting 14 radiopharmaceuticals in all 50 states.
We have problems 15 with the regulations I'm talking about.
We also have i
16 problems with licensing.
I 17 When we go to license a new 18 radiopharmaceutical that contains a NARM radioisotope, 19 it's very, very difficult.
In some cases, we have to deal i
20 with many different states that want many different types 21 of licensing requirements.
22 So, we would like to see the issue of 23 compatibility between the NRC and agreement states 24 handled, and also the, the problem of compatibility 25 between agreement states handled.
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63 1
Also, just to quickly address the options.
{
3 CORAR is a group that can strongly_ disagree with one and I
2 3
five.
Chip, you're looking for someone -- you're looking 4
for strong disagreement.
You have it with CORAR.
l 5
MR. CAMERON:
Okay.
Thank you, Roy.
I'm not t
i l
6 looking for it, but.
i f
7 (Laughter.)
f 8
MR. BROWN:
Issues, options two, three and 9
four, we can go with, but, in particular, three and four, 4
10 we, we like aspects of that.
We're not sure we agree with l
a j
11 the words stron-ly encourage in option number two.
i
{
12 MR. CAMERON:
Okay.
Thank you very much, Roy.
l 13 I guess I would ask Mal, and perhaps Dick Bangart, who's 4
j 14 head of our Office of State Programs, or any of the, the i
15 steering committee.
}
16 We're in the midst of developing a new 17 compatibility policy.
Can, can someone explain why the i.
18 strategic issue focussed on these issues, and did not 19 focus on, on compatibility?
I think there probably is a 20 good reason for that.
21 DEPUTY DIRECTOR KNAPP:
Dick may wish to say 22 something about it.* But from our perspective at the time, i
23 as I.think you recognize, many of the issues and the 24 options are very broadly written.
They're written at a 25 very high level.
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1 And I think I might say that we are more 2
interested in if you like the underlying way in which we 3
relate in this case to agreement states.
Given that that i
4 has been pretty well settled, then the issue of 1
5 compatibility would be if you like an implementation or a i
6 furthering of it.
That would be my view, but Dick is i
7 standing so perhaps he can correct me.
1 8
MR. BANGART:
I'd agree with your comment.
l 9
This is Dick Bangart.
10 Certainly, there is a relationship between the 11 broader direction-setting issues captured in this issue i
12 paper and other ongoing activities that we have in dealing 13 with the agreement states in setting up policies and 4
I 14 programs.
And over the last three-year period, there has 4
15 been a significant number of changes to the agreement 16 state program that have resulted from both Commission 27 direction and input from the agreement statement community i
18 that are in various stages of being put into place right 19 now.
20 And the compatibility issue is one where the 21 Commission a year ago did give preliminary approvel to a 22 new policy statement on that issue, but it was 23 commissioned by a statement also from the Commission that 24 it would not go into effect until implementing procedures 25 were developed and finalized and approved by the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.
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65 1
Commission.
i 2
What Cardelia mentioned was the fact that 3
those implementing procedures, together with at least a 4
slightly revised policy statement, are now out for'public i
)
5 comment.
I believe it's the middle of November that --
{
t 6
November 8th.
We've asked for public comment by i
7 November 8th. 'There is still opportunity to further 8
ihfluence the Commission as we go' forward with developing l
9 our final policy statement and implementing procedures on i
10 the compatibility issue.
l 1
11 MR. CAMERON:
Okay.
Thanks for that 12 clarification, Dick, and I see we have someone over there I
13 at the mike.
14 MR. THOMPSON:
I'm Tony Thompson on behalf of J
15 the National Binding Association.
j
)
16 And with respect to stricter state standards 17 as they relate to the regulation of. radioactive materials, 18 you have some preemption questions that raise legal-19 questions, it seems to me, particularly since the Atomic 20 Energy Act has been interpreted to provide NRC and the 21 Federal Government with preemptive authority.
EPA for 1
22' that matter, too, is with respect to setting health and
)
23 safety standards regarding radiation exposures.
24 At the same time, the Commission has the 25 position on certain aspects of 11(e) (2) byproduct NEAL R. GROSS COURT REPORTERS AND 1RANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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66 1
material, wherein non-agreement states are authorized to 2
regulate without making the same kinds of commitments that 3
the agreement states have.
So it seems to me there a*.e a 4
number of very dicey legal issues tied up in the 5
discussion that was related to evolving authority, more 6
authority, to the states on the regulation of health and 7
safety.
8 MR. CAMERON:
Which would make it even more 9
difficult.
Thank you, Tony.
10 Steve?
11 MR. COLLINS:
Steve Collins, Organization of 12 Agreement States.
13 In a moment when you hear from Ruth McBurney 14 of the Conference of Radiation Control Program Directors 15 you will hear a couple of specific sentences to option 5.
16 But before that, with regard to the comments from the 17 gentleman representing the radiopharmaceutical 18 distribution industry, and for that matter any other 19 manufacturing and distribution that is more than out 20 state, that the states, in fact, agree with your comment 21 with regard to what you're calling a lack of compatibility 22 from states to NRC and state to state.
23 What we intended to convey in our comments 24 that maybe wasn't clear enough is that as a part of this 25 DSI, and the implementing procedures for adequacy and NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE.. N.W.
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67 1
compatibility policy statement, our proposal is -- and 2
that partnership concept that we explained -- is that the 3
states and the NRC work together on deciding what 4
regulations are needed, what policies are needed, and the 5
exact wording of the model rule or regulation that will be 6
used by each state and the NRC in its promulgation l
7 process.
8 The process that we have right now that the 9
agreement states become at times so frustrated with is 10 that the NRC develop ones and then says, "Here it is.
11 Take it or leave it.
This is the way you're going to do 12 it.
And oh, by the way, there's a few where you can be a 13 little more restrictive if you want to."
We don't like 14 that.
We don't think that's the way to go.
15 In the beginning states 25 years ago in the 1
16 infancy of agreement states program, that was'an okay way 17 to start.
And our statements where the Atomic Energy Act 18 recognized that the agreement states would mature and one 19 day become co-regulators or equal partners, with the 20 exception of the oversight role, we are there now.
We 21 want to be recognized there, and we want to start working 22 as partners in this early stage of developing those rules.
23 And we think that the compatibility issues will almost 24 disappear if, in fact, we work together in the beginning 25 to come up with what are we going to regulate, and what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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are the words of those draft rules going to be?
I 2
And we also have proposed through the 3
Conference a new organization to help make that happen, 4
and under that new crganization it would -- basically, the 5
states and the IRC are not supplanting each other's roles.
6 We each have to go through our Administrative Procedures 7
Act process for promulgating a rule.
But the model rule 8
that everybody starts with would be co-developed or 9
developed by all of us, the partners in the process, as 10 opposed to just one and then the one being the big butter 11 from Washington saying, "Do it this way."
12 MR. CAMERON:
And is that going to be Brought 13 out in your comments to the partnering idea?
14 MR. COLLINS:
In the written comments, yes.
15 MR. CAMERON:
Good.
Thank you.
16 Rob?
17 MR. McDOUGAL:
Rob McDougal from SAIC.
18 I arrived a few minutes late for the beginning 19 of the DOE regulation session, but I wanted to find out if 20 there was a discussion of the connection between the two 21 issues -- the agreement state issue and the external 22 regulation issue.
As I'm sure most of you know, the 23 Advisory Committee on External Regulation of DOE Nuclear 24 Safety recommended that, quote, " Essentially all DOE 25 facilities and activities, nuclear facilities and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE.. N.W.
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69 1
activities, be externally regulated."
And the Secretary 2
accepted that recommendation and appointed a task force to 3
implement it.
4 And last I checked, which was some months ago, 5
the task force appeared to be favoring NRC as the 4
6 principal candidate to be recommended as an external 7
regulator.
8 And my question really I guess goes to:
t 9
recardless of whether NRC takes a position on external 4
{
10 regulation, does its preliminary position here on the l
11 future of the agreement states program, which I take to be 12 pretty much option 3 -- continuing that program with 13 adopting current initiatives -- does that contemplate some 14 sort of help to prepare agreement states for the 15 assumption of regulatory responsibility for all of the DOE 16 nuclear materials that would come to be regulated under 17 NRC in the agreement state program?
18 MR. CAMERON:
Go ahead.
19 MR. KNAPP:
I was going to ask Steve if he j
20 wanted to answer the question.
It was discussed briefly 21 yesterday.
And then I think I might have a comment, i
22 Steve, after you.
i 23 MR. COLLINS:
Well, after my comment, I'm sure 24 you will.
25 (Laughter.)
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70 f
1 I think we made the statement fairly clearly J
2 yesterday,.if not today already, that the states that
)
3 currently have these DOE facilities in them think that in l
4 those particular areas we've got more expertise than NRC
[
5 does and we're going to be advising them, if they'll 6
listen.
i 7
MR. CAMERON:
Okay.
Thanks, Steve.
8 And I believe Ruth McBurney from the
]
9 Conference, in her statement at the beginning of the 10 session that you missed, Rob, did speak to the 11 relationship between the NRC and the agreement states in
'egard to the regulation of DOE.
12 r
13 And you may want to repeat that, Ruth.
I 14 MS. McBURNEY:
Yes.
I think -- and correct me 15 if I'm wrong, because I was not at all of the meeting 16 yesterday -- but since those are federal facilities the 17 materials maybe still continue to be regulated by NRC with 18 the assistance of the states.
But what we are seeking is 19 the exemption from sovereign immunity for the other 20 sources of radiation in those facilities where the states 21 do have more expertise, those being the accelerators, the 22 X-ray machines, and so forth, the other sources.
Not just 23 the agreement states, but all of the states -- state 24 programs.
25 On behalf of the Conference of Radiation NEAL R. GROSS COURT REPORTERS AND TRANSCRISERS 1323 RHoDE ISLAND AVE.. N.W.
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71 1
Control Program Directors, I had some other comments on 2
this issue as well.
We concur with the comments made by 3
the Organization of Agreement States but have a few i
4 additional remarks.
5 The mission of the Nuclear Regulatory i
6 Commission is partly to ensure adequate protection of the j
7 public health and safety, and that is one of the primary 8
m$issions.
One important way that this mission is 9
accomplished efficiently is through the agreement states i
10 program, and we support the concept of states as partners i
11 in the effort to provide effective regulation of 12 radioactive materials.
i 13 We would like to add to the list of benefits t
14 that states as a whole provide.
Both agreement states and 15 non-agreement state programs respond to inci, dents.
Steve t
16 mentioned transportation of radioactive material,
)
{
17 reciprocity issues where NRC-regulated material is brought l
18 into the state, a
i 19 We also respond to incidents at landfills and 4
20 scrap yards that may involve the improper disposal of 21 radioactive materials, some of which may involve NRC
- 22 license material.
These incidents can take up a 23 significant amount of staff time with no reimbursement for 24 those resources, i
25' And as Mal mentioned earlier, training should l
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j
72 1
be provided.
Aside from the funding issue, it's necessary 2
to keep training uniform throughout the country in order 3
to know that when anywhere we have to deal with these 4
regulatory issues that there is somebody close by that can 1
5 respond and that the training is consistent in agreement 6
states as well as the NRC staff.
7 Just from a personal experience, I found that 4
8 ha'ving the NRC courses and having the regulators from both 9
the states and the NRC attending these together you not 1
10 only hear the same thing, but you share experiences among 11 yourselves and come out a little more than just being
{
12 inbred in an NRC-only course or a states-only course.
13 There is a sharing of information.
14 Along with the partnership issue on the 15 standards, we are trying to develop -- the CRCPD is 8
16 working with creating an organization or a group to I
17 develop national consensus standards, model regulations j
18 that the federal agencies can use, that the states can
)
19 use.
And Steve touched on it, but it would be in parallel 20
-- the NRC and the states on materials issues, FDA and the 21 states on X-ray issues, and so forth -- to develop i
22 consensus standards.
Not that each one would not have to 23 go through its own rulemaking process, but just to keep 24 the level of uniformity going across the country and that 25 you would not have the bifurcation of all of the state NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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o 73 1
programs.
2 MR. CAMERON:
Okay.
Thank you, Ruth, and 3
thank you, the Conference and the Organization of 4
Agreement States for coordinating your presentations.
5 MS. McBURNEY:
Steve mentioned that both the 6
Organization of Agreement States and the CRCPD had some i
7 comments about 1 and 5.
And as we mentioned earlier, you 8
k*now, concerning EPA, why would NRC want to do that.
9 Again, there would be reciprocity issues involved.
If EPA 10 is regulating states and NRC is regulating the other 11 materials licensees, that would be a problem.
12 And also, it would not make any difference in 13 the cost.
I mean, it would increase the cost on a 14 transition level to put it over in another federal agency.
15 On option 5, the position of both groups was 16 that the NRC and the states, through the CRCPD, should 17 begin working on the long-term goal of as more and more 18 states become agreement states -- not that it would be 19 encouraged -- toward implementing option 5.
In addition, 20 NRC should never consider walking away from regulating 21 licensees in a state where there is no agreement state 22 program.
23 MR. CAMERON:
Okay.
Thank you very much for 24 those comments, Ruth.
25 Richard, do you have some comments?
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MR. RATLIFF:
Yes.
Richard Ratliff, Chief of 2
the Texas Department of Health, Bureau of Radiation 3
Control, not Organization of Agreement States this time.
4 I think that NRC did in their options miss one 5
real specific option that just occurred to me while 6
everybody was talking.
Whereas NRC did not consider the 7
historic relationship with agreement states, where the NRC 8
pa'id for the agreement states' travel and per diem to the 9
agreement states courses and to the annual all agreement 10 states meeting, which has historically been an exchange of 11 information to benefit NRC and the states, and this really 12
-- option 3 talks about continuing the program with those 13 caveats, which is not funding the travel.
And so this 14 other option just I think was not considered and should be 15 considered.
16 Steve had mentioned that NRC receives a lot of 17 free money from states, from state licensees, because it 18 has been several times mentioned that it's an equity issue 19 that the NRC licensees shouldn't be paying for agreement 1
20 state activities.
21 But when you look at it, in Texas alone we 22 have major U.S. manufacturers of well logging instruments 23 and actually doing services -- Slumber J, Western Atlas, 24 Dresser Atlas, Tan Technologies -- and they pay NRC fees 25 because they have national operations that are much higher I
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)
75 1
fees.
So they really are paying, and we do the major
)
1 2
inspections at their facilities as well as our nuclear 1
3 reactor facilities which we do the emergency response at 4
and they pay NRC fees.
5 Also, in NRC NUREG-1311, funding of NRC 6
training program for states, which was published in June 7
1988, on page 2, paragraph 3, it states, and I quote, "The 8
N'RC agreement state program has been reviewed by the 9
General Accounting Office, an internal NRC task force, and, i
10 the National Governor's Association."
11 In their reports, the NRC training program for 1
12 states was consistently identified as the key to enabling 13 states to prepare for such agreements and to make 14 agreement state programs that are adequate to protect 15 public health and safety and compatible with the 16 Commission's program.
Their reports also contain 17 recommendations to expand the state training program.
10 So, in conclusion, I think that NRC should 19 continue the agreement states program with the 20 reinstatement of NRC paying for agreement state training 21.
courses, which is tuition, travel, and per diem, as well 1
22 as travel and per diem for the annual all agreement states 23 meeting that benefits both the states and the NRC and all 24 of the people we regulate.
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76 i
i that some areas, such as international programs, the i
2 agreement states program, and maybe even the research 3
program, should be exempted from 100 percent fee recovery, 4
not be charged to NRC licensees but should be directly 5
appropriated by Congress.
6 MR. CAMERON:
Okay.
Thank you, Richard.
And l
7 you would add those into the Commission's preliminary j
i 8
option.
9 MR. RATLIFF:
Correct.
10 MR. CAMERON:
Okay.
Why don't we take a break 11 and come back and talk about the materials program, unless i
12
-- does anybody have any final comments on this issue?
l i
13 Okay.
How about 10 after 3?
14 (whereupon, the proceedings in the foregoing-15 matter went off the record at 2:55 p.m. and went back on 16 the record at 3 :23 p.m. )
17 MR. CAMERON:
Okay.
If everybody could take 18 their seats, we're going to get started on the last topic 19 for this afternoon.
20 And I have one announcement.
There has been a 21 message on the board for Rod Krich, K-R-I-C-H.
Okay.
22 Well, if anybody knows Rod, you might tell him that.
I 23 don't know if he has picked it up, but -- so any message 24 in anybody's hand --
25 (Laughter. )
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'e 77 1
Okay.
The last topic of discussion in the 2
nuclear materials area is materials oversight, which 3
includes the medical program, and Mal is going to discuss 4
some specifics on that.
5 MR. KNAPP:
I'm going to presume that the size 6
of the audience means that it's late in the day and not a 7
lack of interest in whether the NRC should retain its 8
materials program.
But in my view, the important people 9
are here, so I'm perfectly happy.
It always works.
10 Okay.
DSI number 7:
what should be the 11 future role and scope of NRC's nuclear materials program?
12 And in particular, the NRC's regulation of the medical use i
13 of nuclear materials?
14 I'm going to skim these, because I suspect 15 that most of you in the audience are pretty familiar with 1
)
16 this.
But in a few of the key factors -- this~we might i
17 want to remind ourselves of -- we regulate AEA materials, 18 those created or made radioactive by exposure to radiation 19 during the fission process.
It means we don't regulate 20 NARM, we don't regulate linear accelerators, we do not 21 regulate X-ray machines.
22 I think we are all pretty aware that there are 23 opposing strongly-held views on the part of the regulated 24 medical community and Congress and the media concerning 25 the regulation of nuclear materials in medicine.
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1 In part because of these differing views the 2
NRC instituted a study by the National Academy.of Sciences p
3-some time ago.
Last winter the Academy's Institute of i
4 Medicine provided a report which recommended that NRC 5
eliminate its regulation.
Actually, recommended to l
6 Congress that they pass legislation which eliminates NRC's 7
regulation of its medical use program.
8 Earlier this afternoon we talked about i
9 agreement states, the increase in the number of agreement 10 states.
This is a factor, as I said earlier, on the 11 materials program.
As the number of NRC licensees 12 decreases, we begin to have a smaller and smaller program, 13 and eventually there is a concern that our materials 14 program will drop below a critical mass and require that 15 the program be changed or that it can no longer be self-16 sustaining.
17 And finally, the NRC is conducting business 18 process reengineering of its materials licensing program 19 and anticipates expanding business process reengineering 20 in time to other aspects of its materials program.
For 21 those of you that are not quite familiar with this topic, 22 basically it constitutes standing back, asking how and why 23 what we do -- in this case in licensing -- and asking if 24 there is not a better way to do it.
It comes from the 25 concept that if you've got a process and you start to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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automate, you can make the mistake of automating a procens 2
which is inefficient to begin with.
3 So if you're going to do that, look at the 4
process, make it efficient, and then take advantage of the 5
information technology tools we have today to make that as 6
workable as possible.
We are seeing some success in that.
7 We anticipate reducing the number of staff that we will 8
n'eed as a result of the efficiencies, and we expect to 9
expand that to other areas.
10 Given these key factors, the staff provided 11 the Commission with a variety of options.
The first 12 option would be to increase our regulatory responsibility.
13 We would add X-rays, accelerators, NARM, and NORM, 14 naturally-occurring as well as accelerator-produced 15 radioactive materials.
It would be expanded to cover 16 essentially all forms of ionizing radiation.
17 The second alternative would be to continue 18 our ongoing program.
"With improvements" means 19 improvements such as the business process reengineering I 20 spoke about just a moment ago.
21 The third option would be to continue the 22 program but to decrease the oversight of low-risk 23 activities but continue to emphasize high-risk activities.
24 In talking about our materials program, at this point 25 sometimes it's important to remember that we look at a lot NEAL. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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of things in the materials program, from things as small 2
and as numerous as gauges to things as large and as few as 3
fuel cycle facilities.
4 And so this option would be one in which we 5
consider some aspects of the regulation of nuclear 6
materials and ask whether we should deemphasize those 7
which have a lower risk.
I did not say deregulate; I said d' emphasize.
And what we would do there is something we 8
e 9
would consider as we look at those applications.
10 Possibilities might consider such things as diagnostic 11 medicine or certain gauges which have very small sources.
12 At the same time, if we were to look at that 13 and base it on low risk /high risk, we might find that 14 there are some things which right now we regulate under a 15 general license, or which are exempt, and we might decide 16 the risks are sufficient that maybe we should consider 17 specific licenses.
18 So this would not be a deregulation.
It would 19 be a reconsideration of that which is low risk and that 20 which is high risk and getting comfortable with the fact 21 that our regulations are consistent with the risks we now 22 believe are available.
23 Another alternative would be to accept the 24 recommendations of the National Academy of Sciences, which 25 in essence would be to discontinue our regulation of all NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 medical activities, with the exception of our oversight of 1
2 devices and manufacturers on devices such as -- or, excuse 1
3 me, manufacturers such as radiopharmaceuticals.
i
\\
4 And then the last option would be to f
5 discontinue the materials program.
And although there are 6
various ways to do that, this would not be unlike option 5 1
l 7
in the agreement states paper which you saw in the last i
8 pfesentation.
Given these options, the Commission gave us
,i 9
a number of preliminary views and asked a number of 10 questions.
11 First, their preliminary view would be that l
12 they favor option 2, continuing the ongoing program with i
13 improvements such as the business process reengineering.
14 But they would also like us to at least add some elem.
15 of option 3 -- that is, to consider the low-risk and high-16 risk activities, decrease our emphasis on low-risk l
17 activities, our oversight, but continue emphasis on high-i 18 risk activities.
19 In implementing option 3, we would use the 20 Commission's risk-informed performance-based approach to 21 regulation to decide how we might best approach it, j
22 Specifically, the Commission would ask us to look in the i
23 medical area at which are low-risk activities.
24 Given these views and the issue paper in 25 general, the Commission has asked a number of questions to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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O 82 1
which it particularly seeks comment.
And here, 2
unfortunately, the last slide left the meeting early, so 3
I'm going to have to ask you to look at your handouts.
4 Or, if you're close enough, just at least to help us 5
focus, the last slide appears on the flip chart.
6 There are four particular areas in which the 7
Commission would specifically like comment.
They'd be 8
interested in the views of other affected organizations, 9
such as the Organization of Agreement States, Conference 10 of Radiation Control Program Directors, on applying a 11 risk-informed performance-based approach to NRC's 12 oversight of medical activities.
13 One suggestion which was made where the 14 Commission would particularly like comments would be:
15 should the agency strive to have the remaining non-16 agreement states acquire agreement state authority for 17 medical use only?
Recognizing that states regulate many i
i 18 aspects of medicine which are not based on radioactive 19 materials already.
20 The Commission would particularly like 21 comments in this area on whether a single agency should 22 regulate radiation safety.
This question'is broader than 23 simply the concern about materials in medical.
It arose 24 from some of the comments which we had received earlier.
25 And you've heard today some of the concerns we have with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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83 i
multiple agencies being involved.
Comments as to whether 2
a single agency should regulate radiation safety are i
3 sought.
4 And finally, as a feed to your understanding l
l L
5 of the issues, particularly those involving nuclear 1
6 medicine, this particular paper had about a 30-page 7
appendix added to it, which we hope reasonably accurately l
s'mmarized the views of the Institute of Medicine, and
)
8 u
1 9
summarized the comments which we have received so far or 10 which we had received thrcuch -Sout the end of August on 11 those views.
Any comments on whether or not we accurately 12 reported their views, or the views of others, any comments 13 on whether you agree or disagree with those views, would 14 certainly be well received.
15 That's a quick snapshot of where we are, and I 16 would now again like to give it to Chip and ask for your 17 comments.
18 MR. CAMERON:
Could you just clarify what we 19 mean, just generally I guess, by " risk-informed 20 performance-based"?
And also, in terms of the fourth --
21 or the third specific question -- single agency -- are we 22 talking about single agency at the federal level that 23 would exclude state regulation, or are we talking about l
24 single agency within a state?
I think it might help I
i 25 people if we clarifded both of those.
1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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r 84 1
MR. KNAPP:
All right.
Let me begin with the j
2 risk-informed performance-based and mention a little bit i
'3 about it, particularly as it applies to materials 1
i
}
4 regulation.
[
b 5
Risk-informed regulation, more broadly than i
l
{
6 simply.PRA -- Probabilistic Risk Assessment -- is i
j 7
something that the NRC is moving toward.
As you may have j'
8 h'ard earlier today, a number of our regulations are very l
e 1
l 9
yrescriptive.
The question can be asked:
should we go to 4
4
]
10 regulations which are less prescriptive,-"Do this and this I
11 and this," and more performance based, " Achieve this i
12 result and use what you think is the best way to do it.
?
t 13 Provide us a plan for how you're going to get there."
j 14 The question is:
should the successes and the 15 insights -- or could the successes and the insights gained 4
16 in risk-informed performance-based regulation of nuclear-j i
17 reactors enhance, perhaps make more efficient, more i
l-18 effective, NRC's regulation of its materials program?
l i
19 Now, I misspoke just a second ago.
I don't 20 want to~give you the impression we're asking whither.
The f
21 Commission has issued a policy statement on risk-informed E
i.
performance-based regulation, which says, "This is the 22 23 direction we will go."
Some questions to be asked about i -
24 the materials program are:
how fast and how far?
i i
1 25 And with respect to how far, one can argue NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 2
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4 L
m._,.__
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85 1
that a broad scope licensee with considerable talent and 2
an ability to tap its health physicists could rather i
3 easily handle risk-informed performance-based regulation 4
4 by achieving levels of perforr.unce using their 1
t S
l 5
understanding of radiological matters.
6 On the other hand, some of NRC's licensees, t
j 7
such as radiographers, have limited training, they use the l
8 8
d'evices as a tool, and they might be best served -- we all l
9 might be best served -- by a relatively prescriptive 10 program which does not necessarily emphasize performance-11.
based approaches.
12 So as we look at the materials program as a 13 whole, we need to look at moving towards risk-informed i
14 performance-based regulation and asking:
where is this 15 applicable and where are there places where it is perhaps 16 not that good an idea?
That's risk-informed performance-17 based.
18 Your second question was:
what do we mean by 19 a single agency?
We have a host of federal agencies these 20 days involved in nuclear regulation.
Certainly, we have 21 EPA that sets generally applicable environmental i
22 standards.
We have NRC, with the responsibilities you've i
23 heard about today.
There are certain transportation 24 regulations which are created and implemented by the i
25 Department of Transportation.
FDA has certain regulations NEAL R. GROSS COURT REPORTERS AND TRANSCR18ERS 1323 RHODE ISLAND AVE., N.W.
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l 86 i
l i
1 which 3e implements in the medical area.
2 In some cases, we find that we work smoothly i
3 with other agencies and things don't seem to cause very l
I 4
many problems.
On the other hand, in some areas we do 5
have disagreements.
Those of you that are student.s of the 6
NRC/ EPA relationship would know that although we are i
7 working hard at it there are fundamental differences in 8
the legislation, and occasionally in the philosophies, of 9
the two agencies.
)
10 And we have developed this outfit called the 11 Interagency Steering Committee on Radiation Standards, and i
12 we are trying to come up with consistent ways of doing j
13 risk assessment and risk management.
But it's a long 1
14 process.
j 15 The question could be asked:
given all of 16 this, would a single agency's regulation be the most 17 effective way to go in nuclear materials or for radiation 18 safety in general?
And given that the issue had surfaced, 19 the Commission would be very interested in comments about 20 it.
21 MR. CAMERON:
Okay.
Thanks, Mal.
l 22 MR. KNAPP:
Excuse me.
I didn't finally 23 finish your question.
I'm sorry.
24 We were thinking principally at the federal 25 level.
Your question said:
are we thinking about federal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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e 87 1
and state?
We'd be happy to entertain comments in both 2
directions.
But I think what we had in mind:
would 3
licensees, states, others, be best serve d by a single 4
federal agency?
5 MR. CAMERON:
Okay.
Thank you for that 6
clarification.
7 With that, who would like to start out with a 8
c6mment?
Right there in the back.
9 MR. McINDOE:
Allow me to introduce myself.
10 My name is Darrell W. McIndoe.
I am a full-time nuclear 11 medicine physician.
I represent the American College of 12 Nuclear Physicians and the Society of Nuclear Medicine.
13 I wish to thank you for the opportunity to 14 present oral comments at this time.
15 Both organizations, and I will concur as an 16 editorial comment, think that what you're doing now has 17 been long overdue, and we appreciate the effort that is 18 being expended to take a relook at medical oversight.
We 19 hope that you will take our comments and utilize them in 20 your final decisionmaking.
Rapid action in this area 21 would be greatly appreciated by professionals in these 22 organizations.
23 The last-20 years there has been a steady 24 increase in regulation of nuclear medicine activities, and 25 these tend to be prescriptive type changes and not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE N.W.
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e 88 i
1 performance based.
We do 10 million diagnostic nuclear 2
medicine procedures each year.
We do approximately 60- to 3
70,000 therapeutic nuclear medicine procedures.
4 The amount of regulatory effort required to i
i 5
document, monitor, undergo, and fulfill the prescriptions
)
i 6
is an exceptional financial burden, and I might 1
7 parenthetically add, as a practicing clinician, non-l 4
8 reimbursable.
We cannot add this as our overhead.
9 And when you spend 45 minutes to an hour of i
i 10 your day filling out papers to fulfill requirements and I
i 11 not get reimbursed for it, this is a very expensive 12 proposition when you multiply it over the national 13 spectrum.
And we feel that the NRC needs to assume some i
14 form of fiscal responsibility in terms of trying to reduce 15 this cost to the national medical effort.
16 Today we would like to comment specifically on l
17 three areas, and that's diagnostic nuclear medicine, 18 therapeutic nuclear medicine, and nuclear pharmacy 4
l 19 regulations.
20 As I mentioned before, we do 10 million 21 procedures a year, and these are tracer elements.
We d
l 22 cannot afford to have our diagnostic tool interfering with 23 the body's physiology, so they have to be extremely low l
24 level.
There is no injury.
There is no morbidity or 25 mortality from these procedures.
It has a superb safety NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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89 l
1 record; nobody has ever died of a diagnostic nuclear 4
2 medicine procedure in the last 20 years.
i 3
These things are accomplished in every l
4 hospital.
And as a matter of fact, for a hospital to gain i
5 accreditation it must have access to nuclear medicine 6
technology.
7-Because of its common usage, and because of 8
itis very safe nature, we feel it imperative that the NRC 9
reevaluate its attitude regarding regulation of diagnostic 10 procedures.
We feel that basically a general license 11 would cover diagnostic nuclear medicine.
" hat we would be 12 licensed to received these materials, carry out our 13 professional duties, and on an annual basis to inform the 14 NRC that we are still in business, or we have gone out of 15 business.
This would remove many of the prescriptive 16 requirements in 10 CFR 35, which we find somewhat onerous 17 at times.
18 In the field of therapeutic nuclear medicine, 19 we are increasing the dose and activity which we inject or 20 have the' patient ingest many magnitudes in terms of 21 activity.
But let me emphasize that the amount of 22 activity that we are using, even though it is therapeutic, 23 is not lethal.
And by prescription we cannot give a 24 lethal amount of a therapeutic radionuclide.
25 We think you really need to review the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.
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_. ___ _ ~._-
a 90 l
1 classification of this as a high-risk activity.
Again, we 2
have a superb safety record.
Nobody has ever died in the
]
i 3
last 20 years of an overdose of a radionuclide used i
4 therapeutically.
5 Now, in terms of the fact that we anticipate 6
increasing growth and prescriptions in the area of 7
therapeutic nuclear medicine, we feel that the mix of 8
options in 2 and 3 could be applicable.
And one of the l
9 things that we would like to encourage is that there be a 4
10 participatory-type workshop with the organizations who 11 utilize these therapeutic radionuclides, and that you sit 12 down and hammer out what the risks are, what procedures 13 need to be accomplished in terms of their regulation.
14 And it, I'm sure, is our attitude at the 15 present time -- but there is always room for other comment 16
-- that we'll find that there is very little risk in this 17 area, and that, again, the prescriptive-type approach 18 which is being accomplished at the present time can be 19 reduced and put on a performance-based status.
20 We also have sent a rather lengthy model for 21 regulation of the therapeutic nuclear medicine to Chairman 22 Jackson regarding revisions which have been suggested for 23 10 CFR 35.
And this, with other significant detailed 24 written comments, will be forwarded before the closecut 25 date.
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. ~.
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Finally, I'd like to talk a little bit about 2
nuclear pharmacy, and this differs from radionuclide 3
pharmacy manufacturing.
We're talking about the actual a
4 pharmacy application which occurs in hospitals or in free-5 standing -- what we call unit dose organizations that give 6
us our activity to use on patients.
1 7
And we would ask you to strongly consider 8
separating out the regulation of the pharmacy versus the i
9 manufacturer.
The pharmacy fits into our hospital 10 category as part of our armamentarium and the risk again 1
11 is at the level that we deal with with patients.
It is 12 not in the risk of manufacturing.
13 These practices of nuclear medicine, nuclear i
14 pharmacy, are state functions.
And we are feeling that
)
15 the NRC should regulate their activities in a similar 16 manner that the state would, 17 In conclusion, we hope to make it clear that 18 our 12,OOO-member Society of Nuclear Medicine and 1,500-19 member American College of Nuclear Physicians favor a low-20 risk approach for evaluating and restructuring the 21 regulations regarding diagnostic nuclear medicine, and 22 hopefully come to a meeting of the minds on therapeutic 23 nuclear medicine.
24 We are happy to engage in any participatory-
'25 type forum that you would wish to set up in order to j
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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o 92 1
establish a performance-based risk analysis and '.cpe we c
2 can assist you in moving forward with the changes that we
- 1 1
3 are recommending.
But this does not preclude most of the 4
stuff that we have said.
It is basically with options 2 1
5 and 3, but I think we a]:0 need to look very strongly at 6
the possibility of re' quiring congressional legislative J
7 activity to perform some of the goals that we hope to i
8 reach.
4
[
9 Thank you for allowing me to testify.
10 MR. CAMERON:
Okay.
Thank you for the i
j 11 suggestion.
Is it Dr. McAdoo?
12 MR. McINDOE:
McIndoe.
13 MR. CAMERON:
McIndoe.
If you could just bear 14 with me for a minute --
15 MR. McINDOE:
Sure.
I' 16 MR. CAMERON:
-- I did have a clarifying 17 question for you.
4 18 Clare, could you put the options back up for 19 us?
I J
20 Basically, what I heard you say is that the 21 Society and the College would endorse options 2 and 3 --
i 22 in other words, look at apply a risk-based, risk-informed, i
23 performance-based approach under 3, and that that 24 theoretically would take care of most of the problems that 25 you see with the Part 35 regulations.
Is that correct?
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93 4
1 MR. Mc1NDOE:
Well, let me just put it this 2
way:
there are things which we feel that you have the 3
capability of doing very rapidly and allowing us to get on 4
with our business that can be done without legislative 5
affect.
i 6
But when you take the entire problem of the 7
materials and the nuclear medicine radiopharmacy, j
8 etcetera, etcetera, it may be necessary in the future --
9 which typical of any legislative action takes a lot longer j
t l
10 time than a 90-day comment period in the Code of Federal i
11 Regulations.
So what we are asking for is a sort of " step 12
' briskly forward" and do che recommendations which are
)
13 within your authority to do and, if necessary, also fall 14 back when necessary for legislative action.
j 15 But to anse;er your question:
yes, a lot of it 16 could be solved by taking diagnostic nuclear medicine, 1
17 making it nothing more than a general license, and that 18 would remove 10 million procedures out of the pipeline in 19 terms of paperwork on them.
And we're still going to have 20 to keep accurate records, but it's one of those things 7
i 21 that it just doesn't have the same onerous time-consuming 22 properties that you go through when you're fulfilling all 23 of the regulations of CFR 35, and cross the Ts, dot the 24 Is, and make sure this is done and that is done and 25 something else.
And what we're really after is:
hey, are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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1 we doing a good job and we're doing it safely?
)
2 MR. CAMERON:
Okay.
And I take it that you're 3
not endorsing -- you're not necessarily not endorsing --
4 but you're not endorsing at this time option 4, which ties 5
into the Institute of Medicine report.
That's what I 6
really wanted to clarify.
7 MR. McINDOE:
Right.
And I think the 8
Ihstitute of Medicine report -- quite honestly, I think 9
most of us sort of look at it and say, "Wouldn't that be 10 wonderful?"
But there is reality also.
And I think we 11 would like to get things done that we can get done now, 12 and if it comes out to the fact that -- sometime later on i
13 that there is an omnibus medical nationwide concept in 14 terms of regulation, and so on, that requires 15 congressional action, so be it.
16 What we're trying to do is give the best 17 service that we can for our patients at the least cost.
18 MR. CAMERON:
Okay.
So that implementing 19 options 2 and 3 would not only be a big first step, but 20 maybe the only step necessary to avoid implementation of 21 option 4, I guess is what you're saying.
22 MR. McINDOE:
I would say that that is, you 23 know, a reason -- at this stage in the game, we don't know l
24 what the future holds.
And it may be that going through I
25 changes in 2 and 3 may suddenly bring to the surface NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1
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=
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95 1
something that we haven't thought about that would take 1
2 congressional action to do.
I don't know.
I think the --
3 MR. CAMERON:
Okay.
4 MR. McINDOE:
-- just one of those things, 4
5 though, that come in and say, "Let's tn.e the Institute of 6
Medicine report and institute it tomorrow."
It isn't 7
going to happen tomorrow.
And I think what we're really 8
after is something we've been after for the last 10 or 15 4
9 years, and that is pull down on the noose a little bit and 10 give us some breathing room.
And that is to cut out 11 diagnostic nuclear medicine and understand the very low i
12 risk that's associated with therapeutic nuclear medicine, 13 as well as nuclear pharmacy.
14 MR. CAMERON:
Okay.
Thank you very much, Dr.
i l
15 McIndoe.
That's enlightening, at least to me.
16 Do we have some further comments on the j
17 options or on some of the points that Dr. McIndoe raised 18 in terms of the risk-informed approach to medicine or the 19 suggestion that we do an enhanced participatory process on 20 potential revisions to Part 35?
21 Tom?
22 MR. HILL:
Tom Hill with Georgia Department of 23 Natural Resources speaking on behalf of the Organization i
24 of Agreement States.
25 I think in my comments that I have here we'll NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 j
1 address some of those.
I think we have added maybe one l
J l
2 additional step to what the previous commenter made, so 3
let me make these and we'll get to those points I think.
4 The organization of Agreement States supports 5
the concept of a consistent, unified, national program for 6
the regulation of all sources of ionizing radiation.
It 7
makes little sense to continue to divide radiation 8
piograms according to historical distinctions.
9 However, NRC's strategic assessment and 1
]
10 rebaselining initiative, stakeholder involvement process 11 paper, falls shorts in addressing all radiation safety 12 issues and doesn't prcvide a complete perspective on this 13 issue.
Little mention is made that the majority of 14 radiation exposure is from non-AEA sources, and thus gives 15 the impression that only minor changes to NRC's program i
16 are needed.
l 17 Further, it appears to provide questionable 18 information to support its conclusions -- for example, the i
19 statement that it would take several hundred FTEs to 20 regulate ~ discrete NARM.
21 OAS supports efforts to identify regulations 22 that are unnecessarily burdensome, duplicative, or too 23 prescriptive.
This is especially needed for Part 35.
24 The option of using a risk-based approach is 25 supported by most of the states.
However, such criteria NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoOE ISt.AND AVE., N.W.
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must be uniformly applied to both existing and proposed 2
regulations.
Identification and classification of low-3 risk activities should be done in conjunction with the 4
agreement states, and we ask that it be done in j
5 conjunction with them.
6 NRC must not abandon regulatory control over 7
low-risk activities solely to reduce its regulatory 8
bdrden.
Such an action would result in additional 9
problems faced by all radiation control programs, such as i
i 10 the problem of poorly controlled, generally licensed i
11 devices.
12 Although this paper purports to address all
- t 13 materials oversight, the vast majority of the paper 14 focuses only on the medical area.
The organization of i
l 4
15 Agreement States is in support of NRC's initiatives to 16 streamline the licensing process, eliminate duplicative or i
17 contradictory regulations, update regulatory guidance for 18 all categories of licensees, not just the medical 4
19 licensees.
I 20 We would caution the NRC not to abandon the 21 regulation of radioactive material altogether.
The use of 22 radioactive material in this country is safe for workers, 23 because there are established requirements for users of 24 radioactive material.
The public is protected because of 25 the regulatory community's diligence in ensuring that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 1
individuals using radioactive material do so safely.
2 In some cases, it is necessary to modify the 3
regulations to be less prescriptive.
But it is not 4
necessary to relinquish all control over the safe use of 5
radioactive material.
In fact, it is appropriate for NRC 6
to consider expanding its regulatory authority to 7
establish uniform safety standards for all forms of 8
ionizing radiation.
9 Some specific comments on the options.
Option 10 number 1 -- the increased regulatory responsibility with 11 addition of X-ray accelerators, naturally occurring 12 material As indicated on page 15 of DSI 7, agreement 13 states are in support of establishing one federal agency 14 to work with the states to establish basic standards for 15 all uses of radioactive material.
16 We recognize that this is a major departure 17 from the current federal approach.
However, we believe 18 that it makes sense to treat all ionizing radiation 19 equally.
A rem to an individual is still a rem, whether i
20 it comes from AEA material, NARM material, or an 21 accelerator.
4 22 Although this report states that it would be 23 difficult to support legislation to address all sources of 24 ionizing radiation in the absence of a compelling safety 25 problem, we find that to be a little short-sided.
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99 1
indicated through this DSI, and DSI 2 and 4, many state 2
regulatory agencies already have established programs to 3
address all uses of ionizing radiation in their respective 4
states.
5 States did not wait for an incident to develop 6
a program but have been proactive in ensuring the safety 7
of workers and the public.
In fact, it may be that the 8
states are in a better position to oversee certain DOE 9
operations because the state programs are more 10 encompassing, and that refers back to the earlier paper i
11 this afternoon.
We do not understand the report's estimate of 12 13 several hundred FTEs to regulate discrete NARM possessed 14 by persons in non-agreements states and by federal 15 agencies.
However, if NRC was referring to adding --
16 needing those people for accelerators, for X-rays, j
17 etcetera, then it may be a more reasonable estimate.
But i
18 for discrete NARM only, we do not think so.
19 Looking at several -- the several hundred 20 statement would mean that the effort to be applied to 21 discrete NARM is vastly larger than resources now devoted 22 to agreement material.
So I think those were probably 23 referring to X-rays, accelerators, etcetera.
24 Option number 2 continue the ongoing 25 program of improvement.
As stated above, we support the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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100 1
NRC's effort to identify regulations that are obsolete, 2
unnecessarily burdensome, duplicative, or too 3
prescriptive, in the NRC's work to modify or delete these 4
regulations.
5 We also support the NRC's effort to streamline 6
the licensing process.
The modifications made to date through the business process reengineering should benefit 7
1 8
up to at least a third of NRC's licensees.
We agree that 9
this option should continue to be pursued.
i 10 Option number 3 -- decrease the oversight of 11 low-risk activities with continued emphasis on high-risk 12 activities.
We strongly urge the Commission to reconsider 13 its support for this option.
14 A joint NRC-agreement state working group on 4
15 devices recently reported that problems associated with 16 the NRC's general license program included inadequate 17 regulatory oversight, inadequate control and 18 accountability of devices, and improper disposal of 8
19 devices.
The working group developed straw man solutions 20 and recommendations aimed at regaining control of the use i
21 of both generally licensed and specifically licensed I
1 22 devices.
1 23 These recommendations include requirements for 24 users, distributors, and regulatory agencies.
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a 101 1
oversight, minimal licensing requirements, and the 2
possible elimination of inspections.
As written, it 3
appears that option 3 is advocating regulation of only 4
high-risk activities.
We agree that some streamlining 5
commensurate with risk is warranted.
However, we are 1
6 firmly opposed to abandoning requirements for all low-risk i
i 7
activities, l
8 In evaluating the risk, there are some things 9
now that probably should be regulated a little more 10 stringently than they currently are, such as some 11 generally licensed devices that carry sources of cesium.
12 There are some specifically licensed devices that maybe 13 shouldn't be regulated quite as stringently as they are.
14 So we think that looking at the risk is an appropriate way 15 to go.
16 The regulations are written to minimize risk 17 to workers and the public.
Proper training and use of 18 radioactive material will result in lowering any risk
-19 associated with using radioactive material.
To remove the 20 regulations designed to limit risk, if you remove the 21 regulations designed to limit risk, you can no longer 22 ensure that low-risk activity will. remain such.
23 Option 4 discontinue regulation of medical 24 activities except for NRC oversight of the licensing 25 manufacturers.
The NRC should not discontinue the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE, N.W.
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o 102 1
regulation of all medical activities, just as it should 2
not discontinue the regulation of all other uses of 3
radioactive material.
It is vital that the NRC recognize 4
the professional views of the agreement states, 5
physicians, physicists, pharmacists, hospitals, and 6
professional organizations regarding the unnecessarily 7
burdensome and detailed and prescriptive requirements of 8
P$rt 35, and make modifications.
9 To assist in determining the proper course of 10 action, the NRC, FDA, and representatives from applicable 11 boards of medicine and pharmacy should jointly develop a 12 paper describing the jurisdictional boundaries of each 13 entity relative to regulated use of radioactive material 14 and the practice of medicine.
Such a document would be a 15 great reference point to begin recalibration of existing 16 regulations.
17 Under some circumstances, it may be 18 appropriate for states to regulate federal facilities.
19 This also gets back to the previous comment on sovereign 20 immunity.
It may be appropriate, and we oppose self-21 regulation of medical uses by federal facilities.
NRC got 1
22 out of the business that would have the possibility, then, j
j 23 of self-regulation by federal medical facilities, and we 24 oppose that.
25 Number 5 -- discontinue the radioactive NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE. N.W.
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103 1
materials program.
As indicated in our comments on option 2
3, the NRC must not simply discontinue its oversight of 3
the use of material.
It is reasonable to assume that 4
individual states and federal agencies would self --
5 unreasonable.
6 (Laughter.)
l 7
I thought that was coming out wrong.
l 8
It's unreasonable to assume that individual l
t 9
states and federal agencies would self-regulate to the 10 same degree.
This would cause problems for facilities 11 doing business across state borders.
Deregulation of i
12 radioactive materials sends the message that the material i
l 13 is inherently safe -- a sentiment that Congress and most 14 of the citizens of the country are unlikely to agree with.
15 Regarding the Commission's preliminary views, 1
l 16 we agree with the Commission's preliminary viewc regarding 17 option 2 and caution the Commission to consider possible L
18 problems encountered with deregulation of low-risk uses of 19 radioactive material.
We do not believe there should be 20 encouragement for non-agreement states to develop programs 21 to regulate only medical use.
22 Thank you.
23 MR. CAMERON:
Thank you very much, Tom.
l 24 Mal, do you have --
25 MR. HILL:
Let me make one other comment.
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MR. CAMERON:
Sure.
Go ahead.
)
2 MR. HILL:
I'm sorry.
I forgot this.
There 3
are 29 agreement states, and these views are a consensus i
4 of those.
I'm not saying that it's unanimous, because we 5
do have at least one agreement state that strongly 6
recommends the adoption of option 5.
So I'll put that in.
7 MR. CAMERON:
Okay.
Thank you for that 8
clarification.
9 I think Mal might have some questions for you, 10 and I also have some clarifications to ask you about.
11 Mal?
12 MR. KNAPP:
Actually, I only had one very 13 limited clarification.
The question you raised about our 14 estimates for NRC staff needed to regulate discrete NARM 15
-- thank you for the catch.
That was an error in our
)
1 16 paper.
We meant the resources associated with X-rays, I
17 linear accelerators, and discrete NARM, and we appreciate 18 your catching the oversight.
19 MR. CAMERON:
Okay.
Tom, in relation to 20 option 1, the NRC option of regulatory authority for NARM, 21 I take it that the agreement states would support the NRC 22 seeking legislation to assume that authority, assuming 23 that it would be under the.same sort of agreement state 24 framework if we assumed that authority.
25 This has been suggested by the Conference and j
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's e
105 1
others a number of times in the past, and I just wanted to 2
clarify:
is that what you're recommending?
3 MR. HILL:
Yes.
4 MR. CAMERON:
Yes, it is.
Okay.
5 And going back to the point that Dr. McIndoe 6
raised, it seems like we focus on the Institute of 7
Medicine report.
But it seems like you're also saying l
8 that the initial focus may be on -- may be more properly 9
placed on Part 35.
And after that process, then you could 10 see whether there is any viability left to the Institute
]
}
11 of Medicine report.
Is that a correct characterization, 12 or -- in other words, look at the Part 35 in terms of the 13 low risk -- from the low-risk perspective.
14 MR. HILL:
Yes.
And I think the IOM report 15 kind of is the driving force for that.
16 MR. CAMERON:
Okay.
Okay.
Thank you.
17 How about some other comments on some of the 18 points raised?
Option 1 -- well, Roy, go ahead.
19 MR. BROWN:
Roy Brown with the Council on i
20 Radionuclides and Radiopharmaceuticals.
-21 Let me start off by commending NRC for their 22 ongoing activities that are addressed in item number 2, 23 option number 2, the BPR activities of Part 35 revisions, 24 identifying regulations that are obsolete and unnecessary 25 or too prescriptive.
That's a very good process NRC is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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=,
106 1
going through right now, and by all means that should be 2
continued regardless of what other options are r
3 incorporated.
4 Section 81 of the Atomic Energy Act never 5
envisioned the development of cyclotron-produced isotopes a
6 and NARM-produced or NARM radiopharmaceuticals.
There are 7
many of these NARM radiopharmaceuticals and radioisotopes 1
j 8
ih use today being regulated by a variety of different 4
9 agencies.
CORAR believes one federal agency should 10 regulate these NARM materials and believes it should be 4
1 9
11 the NRC, as outlined in option 1.
1 12 I'11 withdraw my comment about the several J
13 hundred FTEs.
14 (Laughter.)
4
+
15 CORAR feels very strongly in support of the f
j 16 deemphasizing regulatory oversight for very low-risk 17 activities as outlined in option 3.
We believe this is a I
l 18 much more sensible approach than option 4 with the IOM i.
19 report.
20 As Dr. McIndoe indicated, diagnostic nuclear 21 medicine and nuclear pharmacy is a very, very safe 22 activity with very little risk to the public.
And we do i
1 23 believe -- CORAR believes that this activity could be 24 safety deemphasized.
However, we recognize that 4
25 therapeutic nuclear medicine with slightly higher amounts NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISt.AND AVE., N.W.
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of radioactive material presents a slightly higher risk.
s 2
We also suggest that the NRC undertake an 3
enhanced participatory rulemaking to resolve the best way 4
to regulate this therapeutic nuclear medicine.
We also 5
recognize that the manufacturing of radiopharmaceuticals a
6 and medical radioisotopes presents a slightly higher risk, 7
even though it's a very safe activity, and we fully I
8 recognize that we will continue to be regulated by the 9
NRC.
10 Let me point out at this point CORAR had i
11 previously supported the IOM recommendations.
- However, s
12 with the NRC looking at this, considering low-risk 13 activities, and possibly deemphasizing these low-risk 14 activities, we are now withdrawing our support for the IOM l
15 recommendations and getting behind option 3.
So this is a 16 change in policy, a very dramatic change in policy, for 17 CORAR if this goes through as postulated.
18 A specific response to question E -- I 19 mentioned this earlier.
CORAR feels one federal agency 20 should regulate radiation safety, and we feel that agency 21 should be the NRC.
However, CORAR also advocates that a 22 different independent advisory group set the standards a
23 that NRC and the states enforce.
24 Lastly, let me thank NRC for the opportunity 25 to present these comments and let you know that CORAR is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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108 1
very interested and very willing to work with the NRC in 2
the further development of this activity.
3 Thank you.
4 MR. CAMERON:
Thank you very much, Roy.
5 Mal, do you have any questions?
6 MR. KNAPP:
I'd like to explore, Roy, one of 7
your comments a little further, if I may, and you may not 8
have developed it enough.
I don't want to put you on the 9
spot.
10 The concept of a single agency having 11 regulatory jurisdiction, but having an external body 12
' develop the standards -- if you could elaborate on that at 13 all -- for example, who the external body might be or what 14 that relationship would be -- that would be very helpful.
15 MR. BROWN:
We will go into greater detail in 16 our written comments when we submit those next month, but 17 we are thinking along the lines of an NCRP or a group like 18 that, an independent group, not an NRC or an EPA.
19 MR. KNAPP:
Thank you.
20 MR. CAMERON:
Okay.
I think it's interesting 21 what we're hearing, at least from people here today.
22 There seems to have been -- to be a lot of support for 23 option 1, and also option 2, and option 3.
It seems like 24 there is consistency among a number of different people on 25 that.
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Is there anybody out there who doesn't think 2
-- outside of the NRC staff -- that doesn't think that 3
(Laughter.)
4 we should try to assume regulatory 5
authority for NARM?
I am just looking for any other views 6
on that particular option, since we have heard support 7
from a couple of people at least.
8 Go ahead, Ruth.
9 MS. McBURNEY:
Ruth McBurney, Conference of 10 Radiation Control Program Directors, Board of Directors.
11 Just to clarify on option 1, that we are in 12 support of establishing a federal agency to work with the 13 states to establish basic standards for all sources of 14 radiation but not particularly to take on the task of 15 regulating all sources of radiation.
So we're not 16 purporting that NRC take on X-ray and accelerators, and so 17 forth.
18 MR. CAMERON:
Okay.
That's an important 19 distinction.
20 MS. McBURNEY:
Right.
If every state other 21 than Wyoming has an established program for X-ray machines 22
-- and it's unlikely that any state would choose to 23 relinquish control of X-ray services -- for X-ray sources, 24 federal agency should work with all of the states to 25 establish basic standards and minimal requirements.
But NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS i
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the active oversight and inspections should remain the 2
state authority and control, except for maybe federal 3
facilities.
4 MR. CAMERON:
Okay.
Thank you.
4 5
Mal, did you have any questions on that?
6 MR. KNAPP:
One.
If we were to take that 7
approach -- as you're well aware NRC has an oversight 8
responsibility over the agreement states.
I didn't 9
clearly understand whether you would see that sort of an 10 oversight responsibility over states that regulated --
l 11 over regulation of X-ray equipment.
12 For example, let's say that we follow the 13 option, we reach agreement that we work appropriately to 3
a l
14 set standards for safety and for use of X-ray equipment, 15 and that the states use their existing programs to a
16 implement those standards.
In the event that a state did 17 not do that, chose not to do it, or did it badly, would 18 you see that the NRC would have any role at that point, or 19 would you leave that at the, say, discretion of the state 20 legislature?
21 MS. McBURNEY:
Our first option would be to 22 work together for consensus standards, that there would be 23 a consensus standard-setting group made up of the federal 24 agency -- whether that's NRC or whatever -- and the states 25 to set model regulations, and so forth.
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I guess our fallback position, then, would ba I
2 the second option as an agreement statement type i
l i
3 regulation.
j 4
MR. KNAPP:
Right.
But in your first choice, 5
the single agency would set standards --
6 MS. McBURNEY:
Right.
i 7
MR. KNAPP:
-- but would not have the 8
oversight authority.
t 4
l 9
MS. McBURNEY:
That's correct.
3 10 MR. KNAPP:
Thank you very much.
11 MR. CAMERON:
Roy?
l 12 MR. BROWN:
Roy Brown with CORAR.
I wanted to i
13 clarify CORAR's position here.
CORAR is only recommending 14 the adoption of NARM and the use of medical isotopes and 15 radiopharmaceuticals in option 1.
The concern we have 16 right now -- if we're selling a NARM radiopharmaceutical, 17 if we're,
ling it to an agreement state, or a state 18 that'r
's owing CRCPD guidelines, it's a very well-19 addrest:,ed program, a very well put together program, that 20 they have a license and we sell to them and check the 21 position limits, just like an NRC license.
22 However, if we try to sell a NARM 23 radiopharmaceutical or a NARM medical isotope to a non-24 agreement stata, in some cases they have a license, and in 25 some cases they have a registration.
And as Ruth NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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112 1
indicated, in some cases like the State of Wyoming there 2
is nothing.
And that goes back to our comment earlier 3
about consistency as well.
l 4.
MR. CAMERON:
Okay.
Thanks for that 1
5-clarification, Roy.
6 Dr. McIndoe?
7 MR. McINDOE:
Just a question here on using 8
option 1.
Where we have accelerator-produced 9
radionuclides for diagnosis and therapy, I would hope that 10 if this option comes about that it would still tie into 11 option 2, that the regulation and categorization of 12 safety, etcetera, would fit in with that.
j 13 I think the idea of CORAR's having an 14 independent organization be the lead for establishing 15 standards that professional organizations, states, j
16 etcetera, can agree with and say, "This is what we think 17 is the national standard for all forms of ionizing 18 radiation," and then also we previously have mentioned 19 have some participatory type of forum where we can 20 establish a degree of risk with each of these things that 21 we are utilizing.
22 Then, NRC as a regulating agency can see i
23 whether we are in compliance, and in those places where 24 the standard has been established and you review and find 25 that there is non-compliance, then you have the statutory NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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j
113 1
authority to give sanctions.
Or what would be better 2
probably is reeducation, to make sure that these standards 3
are complied with.
4 But I think if you're going to lump things 5
together you've still got to have risk stratification, 6
you've still got to keep the same comments in your 7
options 2 and 3.
And I think everybody feels that it's 8
mbre efficient to have one compact place where you can 9
deal with rather than four or five like we have to have at 10 the present time.
But I still think there has to be the 11 concept of options 2 and 3 that have to be applied to 1.
12 MR. CAMERON:
Okay.
Thanks.
13 And I believe Mal wanted to comment on that.
14 MR. KNAPP:
I just have a question.
I would 15 like to make sure that I clearly understand the positions 16 of several of the recent speakers.
I look up the 17 definition of NARM -- naturally occurring and accelerator 18 produced.
19 Okay.
Let's go a little further; let's talk 20 about discrete NARM versus diffused NARM.
And I'd be 21 interested -- I want to make sure I understand -- diffused 22 NARM, for those of you that may not be experienced with 23 it, would be naturally-occurring radiation in large 24 quantities, such as in piles of ~ailings but tailings 25 which are of other ores, not necessarily regulated by the NEAL R. GROSS COLRT REPORTERS AND TRANSCRFERS u23 RHODE ISLAND AVE., N.W.
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Nuclear Regulatory Commission.
A 2
i My question to the various speakers is:
when 3
you calk about NARM, do you refer to all forms, or do you 3
4 refer to what we might just call " discrete NARM"?
Any 5
help would be appreciated.
2 6
MS. McBURNEY:
I think in our comments we are
]
7-referring to discrete NARM only, naturally-occurring and t
1 8
a'ccelerator-produced radioactive material.
That would be, 9
for example, radium sources, radiopharmaceuticals that are i
.f 10 cyclotron or accelerator produced, waste that is either 1
11 accelerator produced or some of these discrete, naturally-
)
a 12 occurring sources, such as uranium.
13 We're not referring to the types of naturally-I 1
1' 14 occurring radioactive material that a lot of the states 15 are having to deal with, such as phosphogypsum piles, and
)
16 oil and gas, NORM, and so forth.
17 MR. BROWN:
Roy Brown, CORAR.
CORAR's 18 comments were limited to discrete NARM.
19 MR. KNAPP:
Thank you.
20 MR. CAMERON:
Okay.
Does that clarify it for 21 you, Mal?
22 How about anybody else on this particular 23 issue?
Does anybody have any other viewpoints that they 24 want to put on the floor at this time?
25 Ruth?
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i 115 1
1 MS. McBURNEY:
Ruth McBurney, CRCPD, Board of f
2 Directors.
3 Just a few additional comments.
Basically, we 1
4 concurred with the comments made by the-organization of 5
Agreement States that there is a definite need for 6
regulatory reform in the materials area.
Current 7
regulatory schemes should be assessed for effectiveness, i
i i
8 iricluding appropriate risk reduction, comprehensiveness, 9
cost, including both cost to the regulated community and 10 the cost to the regulators, and responsiveness to rapid 11 advances in technology, both in medicine and industry.
12 The public is protected because of the 13 regulatory community's diligence in ensuring that 14 individuals using radioactive materials do so safely.
In l
l 15 some cases, it is necessary to modify the regulations to t
16 be less prescriptive, but it is not necessary to 17 relinquish all controls over the safe use of radioactive 18 material.
19 Just as a matter of discussion, considerable 20 consultation with the state programs must be utilized in 21 implementing any of the options under this issue.
22 Significant risk exists that either, one, further 23 fragmentation of radiation and safety regulations would 1
24 occur with some of the options, or that the NRC will i
25 continue to mandate regulatory requirements that have no i
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116 1
health and safety basis.
2 The important conclusion one must draw from 3
the IOM report is not that medical regulation should be 4
deregulated but that NRC implementation of the 5
prescriptive regulations was inappropriate and heavy-6 handed.
7 Under option 1, we too are in support of 8
establishing that one federal agency to establish -- work 9
with the states to establish the basic standards.
And I 10 think on the other options we were in agreement with what 11 was mentioned by OAS, except under option 3 we have some 12 additional comments.
Hand in hand with the proposals from 13 option 2, under option 3 a risk-based approach should also 14 identify areas of low risk in which NRC and the agreement
)
15 states should reduce the type and degree of regulation, i
16 and other areas in which the degree and type of regulation j
17 should be increased.
18 As mentioned, some of the high-curie, 19 generally-licensed gauges probably should be specifically 20 licensed, and some gas chromatograph sources, which are 21 now specifically licensed, could go to general license.
22 We are opposed to an across-the-board ramping 23 down of all so-called low-risk sources, just for sake of 24 expediency, or whatever.
25 As contained in the -- regarding option 4, as NEAd. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE.. N W.
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I 117 i
1 contained in the position passed by the CRCPD on May 6, j
2 1996, we are concerned that the adoption of this option, 3
as well as option 5, would be considered an unfunded j
4 mandate for some states.
The elimination of the entire 5
program could have a detrimental impact on the uses of i
6 radioactive material on the citizens of non-agreement 7
states which are unable to develop a state program that is 8
not consistent with the national model.
i 9
Separating medical uses of radioactive 10 materials would add to the confusion over jurisdictional I
\\
11 issues among federal and state agencies at a time when we 12 need to be moving toward greater consistency.
In-house 13 sources of radiation are regulated.
And we will be i
14 attaching our entire position on the IOM report as an 15 attachment with our written comment.
16 MR. CAMERON:
Ruth, one clarification.
But 17 you would not be in support of option 4, at least given 18 the possibility of moving forward with option 3.
19 MS. McBURNEY:
Correct.
20 MR. CAMERON:
Okay.
Thank you.
I always feel 21 like I'm trying to trick you.
22 (Laughter.)
1 23 And I am.
No.
i 24 (Laughter.)
25 Wait 'til you see how this looks on the j
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118 i
i transcript.
2 Does anybody else have anything to say?
Any 3
other comments on this?
4 Okay.
Well, just let's close up.
Mal, do you 5
have --
6 MR. KNAPP:
I have a final closing comment.
7 Go ahead, though.
8 MR. CAMERON:
I just wanted to say that we are 9
going to get started at 8:00 tomorrow, and the focus l
10 tomorrow morning is going to be on reactors.
But for 11 those people who are in the materials area, keep in mind 12 that there will be a paper on risk-informed performance-13 based.
14 And Jim, correct me if I'm wrong -- I mean, 15 that's broader -- it's more broadly focused than just 16 reactor regulation, so that it might be useful for people 17 to be there, because I know you have a lot of good ideas 18 on this.
19 We're not going to do a wrap-up session today, 20 but we will do a wrap-up session tomorrow to give you one 21 final chance to revisit things that we have done during 22 the two days.
23 Mal?
24 MR. KNAPP:
Very briefly.
These are not easy 25 issues.
The fact that they are on the table indicates NEAL R. GROSS court RE*oRTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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119 1
their complexity and their. difficulty of resolution.-
In j
2 addressing these things, feelings can run high.
It can i
3 become difficult to be constructive.
I was very, very
{
4 pleased today with the constructive comments, with the 5
spirit of cooperation I heard from the commenters.
You i
6 have made our jobs over the next six weeks much easier.
7 Thank you.
8 MR. CAMERON:
Thank you very much.
See you 9
tomorrow.
10 (Whereupon, at 4:29 p.m.,
the proceedings in 11 t'.ie - foregoing matter went of f the record. )
12 13 14 15 16 17 18 19 20 21 22 I
23 i
i 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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CERTIFICATE This is to certify that the attached proceedings before the United States Nuclear Regulatory Commission in the matter of:
Name of Proceeding:
STAKEHOLDERS PUBLIC MEETINGS HANDLING OF NUCLEAR MATERIALS Docket Number:
N/A Place of Proceeding:
WASHINGTON, D.C.
were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission taken by me and, thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript ~ is a true and accurate record of the foregoing proceedings.
)
i NAL CORBETT RI)lER Official Reporter Neal R. Gross and Co., Inc.
I NEAL R. GROSS CoUM REPORTERS MD TRWSCRBERS 1323 RHoDE ISLAND AVENUE, NW (202) 234 4433 WASHINGTON, D.C. 20005 (202) 234-4433
ud 1
l l
Direction Setting Issue No. 2 3~ ~,
Oversite of the Department of
~
~
- 2. %
Energy October 24-25,1996 t
Sponsor: Malcolm R. Knapp, NMSS l
Writer: Francis X. Cameron, OGC
~
DSI2 jj;
- Should the NRC Seek to Expand its Regulatory Authority and Responsibilities to Include DOE Facilities?
i g..
l i
f l
i i
/
f
.i Key Factors
- The Commission Could Be Required to Assume Jursidiction over DOE Facilities and Activities in Two Ways:
h,
- Congress Could Approve the Recommendations of DOE's Advisory Committee on External Regulation of the Department of Energy Nuclear Safety i
^5;
.+
4
- NRC Jurisdiction Could Increase Incrementally as a Result of DOE Initiatives Such as Privatization of Specific Facilities
- DOE Owns & Operates ~3500 Nuclear Facilities
- NRC Is Require'd to Recover its Budget by Assessing Fees to NRC Applicants and Licensees
- NRC Would Need Considerable Additional l
k Resources l
^!
Options
- Support Broad Responsibility for NRC 4..
Regulation of DOE
,i! ' !6E
- Support Broad Responsibility for Regulating Certain Types of DOE Facilities i
- Oppose Broad NRC Responsibility for Regulating DOE Facilities j
- Take No Position on Broad NRC Responsibility for DOE Facilities
Commission's Preliminary Views
- The NRC Would Not Take a-Position on Accepting Broad Responsibility for DOE 3, ;
Facilities (Option 4). NRC Would Neither
4 Encourage Nor Oppose New Legislation jg g Giving it Broader Authority over DOE Nuclear Facilities.
l
- Given Adequate Resources and a Reasonable Time Schedule to Develop and Initiate a Regulatory Program, the NRC Could Provide Adequate Regulatory Oversight of DOE, If Asked.
V D
i Commission's Preliminary Views (cont)
- If NRC Were to Be Given Added Regulatory Oversight of DCiE Facilities, the W
Commission Would Prefer That the so' Regulatory Responsibilities Be Placed on the NRC on an Incremental Basis and That
- , _m
~:)
Some Type of Prioritization NIethodology Be Used to Determine the Types of DOE Facilities That, If Subject to NRC Oversight, Would Provide the Greatest l
Potential Benefit to Public Health and Safety.
V
.~
The Commission Particularly Seeks
- Comment on Whether NRC Should Fund j
Agreement State Training, Travel, and Technical Assistance.
y&
R; Comments Are Especially Sought from i
l Agreement States, Non-Agreement States, l
Fee-Paying NRC Licensees and Agreement State Licensees.
l I
a
- l i
l Direction SettingIssue No. 4 NRC's Relationship With p
Agreement States 6
October 22 -25, I 996 i
f Sponsor: Malcolm R. Knapp, NMSS
/
t i
DSI4 I
What Should Be NRC's Strategy Regarding States Becoming and Remaining Agreement yv i
States?
- S ~
..;r ua.88 l
/
V
l Key Factors
- The Number of NRC Licensees Is Expected i
(
to Decline as More States Become
?
Agreement States
- The Omnibus Budget Reconciliation Action f"
1:
of 1990 Requires NRC Programs to Be
)
n Funded by its Licensees
~
- NRC's Decreasing Budget May Increase Pressure on the Agency to Minimize its Financial Support to Agreement States
- NRC Is Obligated to Oversee the M
Agreement State Program j
I Options
- Turn the Agreement States Program over to the Environmental Protection Agency Strongly Encourage States to Become pi Agreement States
~M*
- Continue the Current Agreement States Program, Including Adopting Current Initiatives
- Treat Agreement States as Co-Regulators l
- Devolve Regulation of Atomic Energy Act Section 274 Materials to the States
Commission's Preliminary Views
- Continue the Current Program, Including Adopting Current Initiatives j
- Encourage More States to Become and Remain t
40 Agreement States Primarily Through Non-Monetary Incentives as 9;.;
- Explore Providing " Seed Money" and/or Financial Grants to Encourage States to Seek Agreement State Status
- Provide Training to Agreement States Without Charge on a " Space Available" Basis. Funding for Travel and Technical Assistance Would be Borne by the Agreement States h
+
I i
i I
t Direction Setting Issue No. 7
- ' *
- Materials / Medical Oversight l
\\
October 24-25,1996 l
Sponsor: Malcolm R. Knapp, NMSS
)
Writer: Josephine M. Piccone, NMSS j
i i
DSI 7 1
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- What Should Be the Future Role and Scope w
of XRC's Nuclear Materials Program, and in t
g,a h.
Particular, NRC's Regulation of the Medical 3
i L se of Nuclear Materials?
l l
'l Key Factors
- NRC Regulates Nuclear Material Created or Made Radioactive by Exposure to the Radiation During the j
Fission Process in Reactor i
F
- There Are Opposing, Strongly Held Views of the Regulated Medical Community and Congress and the 1
77;
.r.
Media Concerning the Regulation of Nuclear Materials in Medicine
- The National Academy of Science Has Recommended That Congress Eliminate the NRC's Medical Use Program t
- The Number of NRC Licensees Is Expected to Decime as States Pursue Agreement State Status
- NRC is Conducting " Business Process Reengineering" k
of its Materials Licensing Program i
Options
- Increase Regulatory Responsibilitp with Addition of X-ray, Accelerators, and Naturally Occurring f
and Accelerator Produced Radioactive Materials (NARM)
- 7 p0
- Continue Ongoing Program (With Improvements)
- Decrease Oversight of Low-Risk Activities with i
Continued Emphasis of High-Risk Activities j
i
- Discontinue Regulation of All Medical Activities Except NRC Oversight of Devices and Manufacturers (National Academy of Sciences
/
Recommendation) p
- Discontinue Materials Program
t A
- Commission's Preliininary Views
- Continue the Ongoing Program with Improvements (Option 2) and;
,.. g!:.,y
- Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities (Option 3).
- In Implementing Option 3, the NRC Would L tilize the Risk-Informed Performance Based Approach to Determine Which Activities in the Materials Area, and Specifically in the Medical Area, Are Low-Risk Activities.
k
-d 4
i Direction SettingIssue No. 7 i
m a.
1 Materials / Medical Oversight
^
October 24-25, I 996 i
Sponsor: Malcolm R. Knapp, NMSS i
Writer: Josephine M. Piccone, NMSS t
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