ML20149L811
| ML20149L811 | |
| Person / Time | |
|---|---|
| Issue date: | 11/13/1996 |
| From: | NRC |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9611180229 | |
| Download: ML20149L811 (107) | |
Text
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UNITED STATES OF AMERICA
! NUCLEAR REGULATORY COMMISSION i
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Title:
BRIEFING ON CONTROL AND ACCOUNTABILITY OF LICENSED DEVICES - PUBLIC MEETING l
l Location: Rockville, Maryland 1
. Date: Wednesday, November 13,1996 4
Pages: 1 - 68 i
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l l [. Y 9611190229 10CFR 961113 '
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DISCLAIMER This is an unofficial transcript of a meeting of-the United States Nuclear Regulatory Commission held on November 13, 1996 in the Commission's office at One White Flint-North, Rockville, Maryland. The meeting was open to public attendance and observation. This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes. As provided by 10 CFR 9.103, it is-not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.
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- l. t 1 UNITED STATES OF AMERICA L
i 2 NUCLEAR REGULATORY COMMISSION l
3 **** :
4 BRIEFING ON CONTROL AND ;
i l- 5 ACCOUNTABILITY OF LICENSED' DEVICES l i l
6 !
7 PUBLIC MEETING l l
8 ;
I 9 Nuclear Regulatory Commission 10 One White Flint North l'
11 Rockville, Maryland i
! 12 i
! 13 Wednesday, November 13, 1996
.14 l~
l 15- The Commission met in open session, pursuant to l
16 notice, at 2:05 p.m., Shirley A. Jackson, Chairman, i
17 presiding.
18 l 19 COMMISSIONERS PRESENT:
i ;
20 SHIRLEY A. JACKSON, Chairman of the Commission 21 KENNETH C. ROGERS, Member of the Commission
.22 GRETA J. DICUS, Member of the Commission I i ;
l 23 NILS J. DIAZ, Member of the Commission !
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24 EDWARD McGAFFIGAN, JR., Member of the Commission 25
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STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:
1 2 ANDREW BATES, Acting Secretary of the Commission 3 MARTY MALSH, Deputy General Counsel 4 JAMES TAYLOR, EDO 5 DR. CARL PAPERIELLO, Director, NMSS 6 DR. MALCOLM KNAPP, Deputy Director, NMSS 7 DR. DONALD COOL, Director, Division of Industrial 8 & Medical Nuclear Safety, NMSS 9 JOHN LUBINSKI, Co-Chair, NMSS 10 MR. ROBERT FREE, Co-Chair Texas Department of 11 Health 12 RITA ALDRICH, New York Department of Labor 13 MARTHA DIBBLEE, Oregon Department of Human 14 Resources 15 JAMES YUSKO, Pennsylvania Department of 16 Environmental Protection !
17 JOHN TELFORD, RES l 18 LLOYD BOLLING, OSP 19 20 21 22 23 24 1
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1 PROCEEDINGS 2 [2 : 05 p.m.]
3 CHAIRMAN JACKSON: Good afternoon, ladies and l I
4 gentlemen. Today a Joint NRC Agreement State Working Group-5- and the NRC staff will brief the Commission on improving l 6 control over and licensees' accountability for specifically 7 and generally licensed devices. f 8 In June of 1995, the Commission issued a staff ;
9 requirements memorandum approving the staff's plans to 10 proceed with a Working Group to evaluate this issue. The 11 Working Group completed its tasks and issued a. report on 12 July 2, 1996, which included a number of recommendations for 13 improving control and accountability over regulated devices.
14 Today we look forward to hearing from the~ Working 15 Group on those specific recommendations. We also look 16 forward to hearing from the staff on its preliminary views
.17 of the Working Group's proposal.
18- The issue of regulatory control over general 19 licensees has a long and complex history. The Atomic Energy 20 Commission created a general license system in 1959 and in 21 ~ the early 1980s the staff first learned of-smeltings of 22 radioactive sources in steel mills resulting in costly 23 clean-up for non-licensees and lost plant revenues.
24 In 1984, the NRC staff' initiated a study of 25 -general licensees to address device accountability issues.
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1 over the past decade, the Commission has considered various
- l 2- options to address this problem, but most proposals have !
3 required an infusion of significant new resources.
4 Today we hope to hear options that address the 5 limited resource-issues, along with solutions to the l
6 regulatory' problem.
l 7 Now, I understand that copies of the staff's i 8 paper, which is SECY-96-213, the Working Group's report, as i 1
9 well as viewgraphs from Ms. Aldrich, are all available. And !
10 I understand that the order will be the Working Group 11 report, then Ms. Aldrich would like to make some remarks, 12 and then we will hear from the NRC staff. Is that correct?
13 MR. LUBINSKI: Yes, that's correct.
14 CHAIRMAN JACKSON: So do my fellow commissioners 15 have anything they'd like to add at this point?
16 [No response.]
17 CHAIRMAN JACKSON: If not, you may proceed.
18 MR. LUBINSKI: Thank you. I appreciate your 19 introduction. I'd like to start by introducing the Working 20 Group members. To my far right is Mr. John Telford with the 21 Office of Research, NRC, who served on the Working Group 22 Next to him, to his immediate left, is Mr. Lloyd Bolling, 23 who is with our Office of State Programs, NRC. 1 l
24 To my immediate right is Bob Free. Bob's with the i
25 State of Texas and served as the Agreement State co-chair on .i ANN RILEY & ASSOCIATES, LTD.
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5 1 the Working Group.
2 On my far left is Mr. Jim Yusko. He's with the 3 State of Pennsylvania and served as a CRCPD liaison to the 4 Working Group.
5 Seated nextLto Jim is Martha Dibblee from the.
6 State of Oregon. She served as an Agreement State member to 7' the Working Group.
8 And to my immediate right is Rita Aldrich from the 9 State of New York. Rita served as an alternate to the 10 Working Group and attended.several meetings of the Working 11 Group.
12' Two other individuals I'd like to recognize at 13 this time.are Miss Robin Haden, who is with the State of 14 North Carolina. Robin was an original member of the Working 15 Group and attended several meetings and provided valuable 16 input.
17 In addition, Mr. Joel Lubenau served as the 18 initial chair of the Working Group for the NRC. In March of 19 '96 I' succeeded Joel as the NRC co-chair of the Working 20 Group when Joel then accepted a position with the Commission 21 staff.
22 CHAIRMAN JACKSON: I should point out we have a 23 . lot of ground to cover and I think we've allotted about an 24 hour and a half.
25 MR. LUBINSKI: I'll try to move quickly.
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- 6 1 CHAIRMAN JACKSON
- That's a discipline on us, as 2 well as on you.
3 [ Slide.]
4 MR. LUBINSKI: Starting with slide number 2, the 5 Working Group's slides, in licensing we deal with two 6 different types of licensing at the NRC. The special ,
7 licensing which requires a pre-approval -- basically the 8 administrative procedures and training are necessary to use 9 products under this license. There are industrial gauges ,
10 used under this license as well as sealed sources and 11 unsealed material.
12 The general licensing program is in effect without 13 a license being issued to a particular individual. It is in 14 the regulations. It is fairly straightforward. And the ,
15 requirements are all spelled out in the regulation.
16 Therefore, they can receive the material without a license.
17 As stated, the first general license was issued in 18 1959 with the purpose being to save agency resources. Later 19 it was expanded out to include a large variety of devices.
20 The bottom bullet indicates that there were 42,000 21 NRC general licensees and 460,000 devices currently used 22 under the 31.5 license. I'd like to point out that there's 23 NRC general licensees and we're still doing, about rule of 24 thumb, two to one for Agreement States as an estimate. So 25 we're estimating somewhere on the order of 900,000 devices ANN RILEY & ASSOCIATES, LTD.
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7 1 in Agreement States.
2 CHAIRMAN JACKSON: You're pretty confident in the 3 numbers relative to the NRC?
4 MR. LUBINSKI: The numbers from the NRC are from 5 the NRC general license database. Any error _would be 6 misreporting by general licensees into the database. If 7 anything, there's probably a slight overestimate. To give a 8 number on what it would be, I could not say.
9 CHAIRMAN JACKSON: But,you're saying it's complete 10 in the sense of capturing the universe?
11 MR. LUBINSKI: Of NRC licensees, yes.
12 CHAIRMAN JACKSON: Okay.
13 MR. LUBINSKI: Next slide.
14 [ Slide.)
15 MR. LUBINSKI: In looking at the types of devices 16 under a general license we say 460,000. I need to point out 17 that the majority of these devices are fairly low risk. In 18 looking at this slide you can see that 72 percent are exit 19 signs, tritium gas, relatively low hazard, both during use i i
20 and under accident conditions. l i
21 Other devices of lower risk on the pie chart are 22 shown as the chromatographs and static eliminators, so we're 23 talking about 84 percent of the devices being relatively low l
24 risk under the current general license. Jext slide.
25 [ Slide.]
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8 1 MR. LUBINSKI: Under the general license, as I {
2 stated earlier, the requirements for the general licensee !
l 3 are spelled out in the regulations. ThisEis a listing of l 4 .the current requirements, fairly simple and straightforward. !
c 5 Basically, the general licensee receives "a black box." i 6 They can use the device, cannot service the device, are I 7 basically given a list of do's and don'ts. Do's, such as 8- testing the device, maintain the device, maintaining the 9 labeling. Don'ts, don't throw it in the trash, make sure it ;
10 goes back to someone authorized to receive it, Don't 11 service it yourself. Make sure you have someone who knows l 12 what they're doing to service it. Next slide. i i
13 [ Slide.] !
14 MR. LUBINSKI: The reason we can do this under the I 15 general license falls back on the distribution of the j i
16- product. The device itself needs to meet certain safety ;
17 criteria. .This is ensured during the manufacturing and the !
18 design of the device and this is reviewed during the 19 licensing process by NRC.
20 There's an inherent safety to the device and this :
21 looks at use conditions, as well as likely accident l 22 conditions for use of the device. t i
23 The second bullet lists instructions and what 24' we're saying here is the fact that the general licensee does 25 not have to contact the NRC prior to receiving a NRC, they i
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1- need to be aware that they are a licensee and what t
2 requirements they have.
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3 This is done through the vendor. The vendor would i 4 provide them instructions, precautions and licensing !
i 5 information -- again, the list of do's and don'ts that they !
6 need to do. !
7 The last item is the reporting requirement. This 8 is a reciprocal agreement with Agreement State licensees, '
9 that is, Agreement State distributors, where they will tell t
l 10 us which NRC general licensees they distribute to and our 11 licensees will tell the Agreement State which devices. This t
I i 12 allows the regulator to know who the general licensees are 13 and what devices are being used under a general license.
14 CHAIRMAN JACKSON: How often is the database 15 updated?
16 MR. LUBINSKI: The reports are required to be 17 submitted on a quarterly basis. They are immediately 18 updated and again, there's a 30-day grace period on the 19 reporting.
20- The current regulatory oversight. For specific- ,
21 licensed distributors, there's a good track record, i 22 according to the information we have on inspecti'ons of these 23 licensees. They do provide information to the general 24 licensees. They do provide reports to the Commission. The l
25 designs that they have have been preevaluated and they are I
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10 1 manufacturing these devices in accordance with those 2 specifications.
3 They are also subject to inspections, as well as 4 application and annual fees.
5 For the general license users, we're dealing with 6 a much different situation here. We maintain -- that is, 7 NRC, the regulacors -- maintain a listing of the general 8 licensees and what tyoes of devices they have. However, we 9 do not subject them to routine inspections and we only 10 inspect basically for cause, if we have information such as 11 violations, safety concerns or an allegation.
12 In addition, they're not subject to fees, which 13 basically means a general licensee may never come in contact 14 with the regulatory authority -- that, NRC in our case --
15 through the entire life of the device. They may receive it, 16 follow the regulation and then, when they transfer it back 17 to a specific licensee, provide a report to NRC stating that 18 they did such.
19 CHAIRMAN JACKSON: So the distributors are 20 specific licensees?
21 MR. LUBINSKI: The distributors are specific 22 licensees, go through the licensing process and are subject 23 to the inspections.
24 Status of the current program. As I stated, we 25 started in 1959. Only a small number of modifications were ANN RILEY & ASSOCIATES, LTD.
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1 made since 1959 to the actual general licensing program.
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2 However, in looking at the problems that you ;
.l 3 stated earlier in the early '80s, devices showing up in 4 cerap streams, as well as some follow-up studies of ;
5 compliance of general licensees, NRC determined that we-l 6 needed to increase our oversight and a proposed rule was in ;
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7 the form of a registration system for general licensees. !
I j' 8 What's important to note about this registration )
9 ' system is it applied to all general licensees. That would 10 be'the entire 42,000 licensees, along with their 460,000 11 devices.
12 That became a big problem when we tried to 13 retrofit the system to all these devices. We had to follow 14 up on reports of loss, follow up on miscommunications where
! 15 a vendor may have given us information and the licensee !
l I i 16 didn't report and now we have to track down was there an 17 authorized disposal?
l 18 The registration system did include annual mail 19 contacts, where we would contact the licensees as to whether 20 they did have their material.
21 The rulemaking was published as a proposed rule in j 22 1991. Extensive comments were received and resolved.
23 .However, in 1993 the rulemaking was put on hold. Basically, 24 the issue of resources came back up as the major problem and 25 the major problem with the resources, again, was the 3
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12 1 retrofitting of the rule to all existing devices.
- 2 The rule continues to be on hold, again because of 3 the low risk with the current devices and the resources 4 needed to backfit the program, retrofit the program.
5 However, we have continued -- and I say we, NRC 6 staff -- in the area of looking at some of these problems.
7 Specifically, we have tried to address the problem of i 8 baghouse dust disposal, which has resulted from devices 9 accidentally being smelted, and other initiatives, such as 10 the formation of the Working Group, the formation of the 11 Working Group to get a national perspective, as well as 12 input from the Agreement States on the process.
13 At this point I'd like to have Bob Free go over 14 the next few slides and discuss some of the involvement of 15 the states in the process some of the preliminary 16 conclusions.
17 [ Slide.)
18 MR. FREE: Thank you, John.
19 The Working Group, of course, felt that there 20 definitely was a problem but needed to identify, if they '
21 could, the scope of the problem. In order to do that, 22 public meetings were held and a public workshop. There was 23 a public meeting in October, one in December, and the public ,
24 workshop was held here in January of this year. !
25 The Working Group determined or identified that ANN RILEY & ASSOCIATES, LTD.
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13 1 there had been a number of smeltings over the course of the 2 past 13 years. About 20 smeltings had occurred in steel 3 mills and they ranged in cost to the mills anywhere from 3 4 to 23 million dollars.
5 Also, there were devices turning up in scrap yards '
6 and other locations that states either had to decide to 7 collect themselves, locate a licensee responsible or to get 8 the finder to dispose of them.
9 A survey was conducted by the NRC in 1990 of 3,000 10 general licensees that indicated there was a problem in that 11 area, that is that about 60 percent did not respond ;
12 initially and eventually determined some number less than 1 i
13 percent of the devices couldn't be located. Those are small 14 percentages, but when you look at the large numbers of 15 devices we're dealing with, they can be significant.
16 COMMISSIONER DICUS: Was this survey of general !
17 licensees only for gauges or was it all the general !
18 licensees, a representative number of all the general 19 licensees? -
20 ~MR. FREE: There were 3,000 general licensees that 21 were surveyed.
22 COMMISSIONER DICUS: I know but --
23 MR. LUBINSKI: If I can answer that, there were 24 actually three categories of general licensees and 25 approximately 1,000 per. That was industrial gauges, ANN RILEY & ASSOCIATES, LTD.
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analytical devices and exit signs. The results varied a bit 2 across each type of license. However, for the analytical
- 3 gauges and the industrial gauges, the results were fairly 4 similar -- the same numbers not responding, the same numbers 5 having difficulties locating.
6 It appeared in the area of exit signs that there 7 was actually more persons who could not account for gauges.
8 However, it was a lower risk item where there's not as much 9 concern.
l l
10 MR. FREE: Thank you, John. !
i l 11 I mentioned public meetings and the public l
l 12 workshop that were held. Throughout the process, the l
1 13 Working Group attempted to identify as many stakeholders as 14 possible. Joe'. Lubenau, who was co-chair at the beginning 15 of the process, spent a lot of time and effort attempting to 16 identify stakeholders, j 17 Participants at the meetings included Agreement 18 State representatives, members of the steel manufacturing 19 industry, licensees, vendors, manufacturers of the devices.
20 The Agreement States provided the three Working i
21 Group members and an alternate and conducted a survey to get l l
22 some consensus among Agreement States so that there was !
I 23 agreement that at least there was a problem and the extent 24 of the problem. All of the Agreement States agreed that J
25 there was a problem. l ANN RILEY & ASSOCIATES, LTD.
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1 The Working Group, in its discussions, identified 2 initially seven areas of concern and then another four. I l 3 won't try to list or disc,uss each of those, but 4 compatibility was one of the major ones. Cost and fee 1
5 considerations. Changes in device manufacturers or changes 6 to regulations affecting devices that are already in 7 possession, versus newly acquired.
8 Device disposal. One of the categories that we 9 discussed quite a bir. under disposal had to do with orphaned 10 devices. We had defined orphaned devices as devices that 11 turn up in the private sector and someone trained to handle 12 them would be required to take responsibility.
13 Eventually the Working Group came up with a straw-14 man proposal identifying problems and solutions. One of the 15 problem areas was regulatory oversight. The Working Group 16 felt that some enhanced regulatory oversight needed to be 17 conducted in order to control or contain these devices so 18 that they weren't lost or improperly disposed of.
19 Increased contact between users and regulators and !
1 20 attempts to identify early warning signs through possibly j l
21 self-inspection reports that would go out to the users. ]
22 control and accountability was another problem i 23 that was addressed. Solutions proposed were require devices 24 to have labels or tags containing certain information and to 1
25 have a certain durability. Also, the proposal would ANN RILEY & ASSOCIATES, LTD.
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i 16 4 1 recommend that a person responsible for the device and a
- i i
- 2 back-up person be identified. ,
3 CRAIRMAN JACKSON: Let me ask you a question, in 4 I Lterms of control and accountability. Inherent in this has i
5 to do with requirements that Agreement States might impose- i
.6 versus what we might. Should there be separate databases?
7- I mean, did you consider that issue specifically? i 1
i 8 MR. FREE: At the workshop in January a proposal
- 9 was put on the table by -- we call it the Jack Dukes ;
10 proposal. He worked for ABB and-at the time suggested'a f i
11 national database of ~ devices -- cnr sources. And there was a i
12 lot'of agreement with that. I 13 Subsequently, we did a survey that was mailed out i
14 and also handed out at the CRCPD meeting. A number of I 15 states agreed with that. The states seemed to be split I l
16' about 50/50 in terms of agreeing with the utility of the l 17 national database.
18 An additional problem that the Working Group 19 delved into was improper disposal of devices and suggestions 20 there or the recommendations include methods to increase 21 knowledge on the part of the users as to what devices they 22 have, where they are and maintaining some sort of j 23- accountability for those, communicating'between the user and i
24 the regulator and also the vendor so that when a device is l 25 put in motion, there's something in place so that a back-up i
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- l 1 system, if you will, exists to track it.
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.2 CHAIRMAN JACKSON: Before_you go on, let me ask i 3 you this question. Again, and I'm asking you because you j t
4 represent one of the Agreement States, some Agreement States !
5 do not have civil penalty authority. So in looking at this l 6 first bullet as part of the solution, did you consider what !
7 types of nonmonetary penalties could those Agreement States '
8 impose that do not have civil penalty authority?
9 MR.. FREE: My understanding is that there are a l t
! '10 number of different situations existing in states, f
, 11 regardless of whether Agreement States or non-Agreement, 1
12 relating to civil penalty authority, and some of the non- ;
13 Agreement States do have some regulatory responsibility for >
f 14 non-byproduct material. They would also be affected by some j 15 of these recommendations if they chose to use them. !
16 I've been told on.one occasion that a state didn't i 17 have any_ authority to levy civil or administrative 18 penalties. In Texas we use administrative penalties. We 19 also have a system for using our attorney general's office r 20 fc civil penalties. Other states do use civil penalties.
21 I don't have numbers that would indicate how many 22 could or how many could not use some sort of penalty system.
- 23 CHAIRMAN JACKSON
- Okay. At this point, .then, you l' l 24 haven't really had the opportunity to consider real-25 mechanisms for implementing this kind of a solution.
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1 MR. FREE: Not for civil-penalties. The members '
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2 of the Working Group represent states who have regulatory- l 3_ . processes in place now that address-the other regulatory l j
4 controls that were suggested.
f 5 One of the reasons for recommending a method for l
6 penalizing persons for improper disposal is that it's
{
7 another way to get people, persons who are responsible for f 8 the' devices, to use whatever they have available, whatever l 9 means they have available to maintain accountability for the t t
i 10 device and to dispose of them properly. j
)
11 I think what happens on a number of occasions is, j 12 though, that companies go bankrupt and then, in the transfer l i
13 of properties, these devices become lost. '
14 CHAIRMAN JACKSON: Do you have any data that ,
15 tracks the handling and disposition of the devices as a i 16 function of the regulatory authority of the states in which 17 different. improper disposals take place?
{
18 MR. FREE: Not in terms of the type of -- !
19 CHAIRMAN JACKSON: What I'm trying to get at is in !
20 terms of a remedy, the issue has to do with effectiveness of !
21 the remedy and that, then, tracks into some kind of 22 regulatcry space. And you have some of these devices that j 23 may be inpreperly disposed in Agreement States, as you point l 24 out, some in non-Agreement States, i 25 Even in some of the non-Agreement States, the ANN RILEY & ASSOCIATES, LTD.
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- 1 states have certain regulatory recponsibilities nonetheless 2 and the issue is to try 'c cget some coherent picture of '
3 what's out there relative to what we might do, whether it's ;
4 in terms of a direct oversight or in terms of what might 5 happen vis-a-vis adequacy and compatibility of Agreement 6 States programs.
7 i'E FREE: I see. We had a lot of discussion 8 about compatibility issues and --
9 CHAIRMAN JACKSON: I'm going to ask you a question 10 about that.
11 MR. FREE: I think that your question is leading 12 into that and right now a number of -- well, states !
13 generally have various means of coping with general-licensed 14 devices. That was the initiating problem that the Working
! 15 G;oup was based on.
- 16 When we began our discussions it became apparent l
17 that a number of states had different means of coping with l
18 these problems. Some have taken it on their own to either
[ 19 specifically license GL devices; others have taken other i
20 approaches. In Texas we have what we call a general license 21 acknowledgement program.
[ 22 So to answer your question, I think there's a wide 23 range of methods out there that are currently being used.
l t
24 What we tried to do as a Working Group was come up with i
- 25 something that we could reach consensus on that could at t
i e
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20 i 1 least form a foundation to build on adequate control, 2 regulatory control of the devices. !
3 Another item on that issue also has to do with the 4 Working Group recommending that vendors provide disposal 5 information to users prior to transfer, or along with the ;
6 transfer of the device. That is, the Working Group felt 7 that with that, vendors could be made aware of the cost of r 8 disposal, the potential cost of disposal, and know their 9 concerns related to properly handling of devices after 10 they're through using them.
11 And the last issue or problem that we addressed 12 had to do with orphaned devices. I say last because it's 13 last on this list. It's something that we discussed and 14 agonized over throughout our meetings.
15 Orphaned devices is a situation that I find 16 troublesome personally because among my responsibilities is 6 17 responding to incidents and recovering or retrieving some of ,
18 these devices. And, as a regulatory person attempting to ,
19 identify the ownership, many times that's impossible.
20 I've found that there's a variety of ways of 21 handling orphaned devices around the country. Some 22 regulatory bodies leave these devices in the possession of 23 the finder, with some sort of mechanism for tracking it and 24 assuring that it's adequately stored. Others take 25 possession of them and still others try to find a licensee ANN RILEY & ASSOCIATES, LTD.
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- l 1 who's willing to take possession of it until some
- 2 arrangement for disposal can be maintained. '
3 Now, these finders generally, when we're talking 4 about these types of devices, small gauging devices, the 5 disposal costs of these things can range upward to $20,000. ;
i 6 For a small entity, a person who makes his or her living i
7 handling scrap, that's a very significant cost. Many of 8 them have concerns over spending $800 for a radiation 9 detector.
1 10 So the Working Group felt that some method needed 11 to be developed so that there was adequate means of taking 12 possession of these devices, putting them under adequate 13 control and disposing of them.
14 CHAIRMAN JACKSON: How many such devices are i
15 there?
16 MR. FREE: Orphaned devices?
17 CHAIRMAN JACKSON: Right.
i 18 MR. FREE: I don't have a clue. I think we 19 estimated at one point in our discussions regarding just 20 gauges, cesium gauges, perhaps 80,000 in existence across 21 the country, and that was a wag.
22 But we also discussed, in our recommendations for 23 enhanced regulatory programs, what types of situations 24 should we address. I think there are three situations.
25 We have devices that are already lost that are ANN RILEY & ASSOCIATES, LTD.
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22 j i
i going to turn up somewhere. We have devices that are in '
l 2 someone's possession now and may be in jeopardy of becoming 1
)
3 lost, for whatever reason. And then we have devices that 4 are going to be manufactured and produced in the future.
5 I don't think it would be adequate to simply 6 address future manufactured devices. There are too many out ;
7 there already that I feel are in jeopardy of becoming lost 8 and becoming a problem. l 9 CHAIRMAN JACKSON: I think the Working Group's 10 paper recommended NRC funding for the ultimate disposal of 11 orphaned devices that are not the responsibility of DOE or 12 the EPA.
13 So the question I would have for you, whether you 14 considered it, if the NRC funds that ultimate disposal of 15 orphaned devices, being orphaned in the sense that you say, 16 given that we're a fee recovery agency, how would you 17 suggest that NRC recover those disposal costs?
)
! 18 MR. FREE: The Working Group didn't feel adequate .
)
19 to really address --
20 CHAIRMAN JACKSON: You punted it to us. )
21 MR. LUBINSKI: If I can expand on that, we did go ,
l 22 into a lot of discussion on the subject. Maybe the end 23 result, as you said, was we definitely punted at that point.
24 However, in the recommendations, the first part of 25 that recommendation for orphaned devices and ensuring proper I
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i 'l l :
l 23 ,
l 1 disposal was that DOE and EPA definitely have some i
2 responsibilities in this area. .!
l 3 We weren't sure, because there are not definite '
L 4 agreements in place, to say whether or not there will be a ;
l 5 " piece of the pie" left that would not be-covered by those l l 6 two agencies. Our statement was that felt a health and !
l 17 safety standpoint and protection of property, we needed l 8 these devices to be controlled. l 9 We looked at funding and considered where we would ;
10 go for funding. We threw around the ideas of recommending l
l 11 that NRC go to Congress and ask for a fund to be set up as >
12 part of our funding -- that is, NRC's funding coming from '
13 Congress for this, as part of DOE's funding coming for this, 14 as part of a. surcharge over all general licensees'and all i
15 specific licensees, as being a possible solution. ;
16 Because of this issue of fees and it being_such a 17 volatile siltation, we decided at that point instead to l
l 18 recommend that not necessarily NRC provide the funding but 19 NRC ensure that the funding is available. Where it would l 20 actually come from, whether or not it would come from i l i l 21 Congress or another agency or whether or not there would 22 need to be a surcharge along the line somewhere would need 23 .to be a final decision, a policy decision made by NRC, and 24 we could not bring ourselves to make that kind of 25 recommendation.
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24 1 MR. FREE: I didn't mean to imply that I was
- 2 finished.
3 [ Laughter.]
4 MR. FREE: That's true. In fact, one thing that 5 we did do at the Vancouver-Washington meeting was invite a 6 representative from the Northwest Compact to hear our plea 7 and find out what he might have to add or suggest.
8 I've talked to our low level waste authority in 9 Texas and frankly, a lot of people are concerned among the i
10 waste disposal industry that certain individuals might take 11 advantage of the situation if compacts simply agree to take 12 these devices when they were found.
13 So there are a lot of complicating features 14 involved in trying to persuade a compact or a waste site to 15 accept the disposal of these devices.
16 COMMISSIONER DIAZ: Is there an estimated cost for 17 programming on a yearly basis?
18 MR. FREE: If they're found by someone who has no 19 knowledge of radiation protection, safety or waste disposal, 20 they're going to have to rely on someone to come in and 21 survey, package, ship, deliver, and then the waste site to 22 dispose of it. Estimates, if one of the waste site !
-23 contractors takes it from cradle to grave, are up to j 24 $20,000.
25 COMMISSIONER DICUS: Along those same lines, do {
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25 I l ,
l 1 you have any information about individual states in the i
l 2 situatoin of orphaned devices and when one would show up in -
3 the private sector with an innocent bystander, the state, in l
4 effect, ultimately became the proud owner of this device.
i !
! 5 Do you have any data on that? I know of at least one state ,
6 that did have to go.out and bring them in and did have to !
l '
! 7 dispose of them, at a cost'of about $100,000 when several of 8 them were sent off at one time, i'
9 So I just wonder because it's a case where the j 10 states assume the responsibility, and I know there are one 11 or two or three. I know there's more that one state that .j
. 12 assume the responsibility and the cost of doing this. I ,
t l 13 just wondered if you had data on that. l l 14 MR. FREE: Only anecdotal information. In Texas l 15 we have storage facilities for devices. And what we've done L
! 16 is collect these and store them. We haven't actually had to ,
l l
17 pay disposal costs yet. And every year we go through an 18 agonizing discussion over whether we're going to continue to l 19 collect them. And it goes beyond byproduct material to the j j 20 realm of radium and other NARM materials. l 21 I know that some states are not able to collect 22 these because they don't have the facilities to store the 23 devices in the first place. To me, that's a whole new 24 Working Group operation.
- p. 25 MR. LUBINSKI: At this point I'd like to talk i
I i
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26 l' about the recommendations that were specifically identified 2 in the Working Group report'. Bob has given basically a 3 skeleton of what the recommendations are.
4 The first recommendation we call increase 5 regulatory oversight and we left it as that for the fact of 6 the compatibility issue. We talked about that already or 7 touched'on it.
8 Our recommendation for this type of oversight 9 would be a compatibility 2 recommendation, the reason being 10 that there are certain aspects of the program that would 11 need to be in place, and that's what we identified as our 12 increased oversight program -- annual contact with 13 licensees, licensees doing inventory. These are essential.
14 The method in which a state would do that we 15 didn't-think was important. If'a state would like to go'out 16 - and do inspections every year, fine. Why should we limit 17 them and say it needs to be a computerized database?
18 However, with that said, we felt the most 19 efficient way of doing this would be a computerized 20 registration system. The idea, we'd like to be able to say 21 it's a great new idea that we came up with. However, as 22 already stated, the 1991 rulemaking talked about 23 registration. A proposal from one of the vendors referenced 24' registration.
25 We basically tweaked it a bit. The one major i
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1 27 ;
1 . thing we did~is we said that this registration would not i t
2 apply to all generally licensed device. It would only apply l l
1 3 to those that contain certain isotopes that we felt were of 4 ' concern, specifically cesium, cobalt, strontium and.all l
5 transuranics. l l
6- The reason we picked these were based on health ;
7 .and safety concerns when these items are released to the i
8 public; in addition, what they could cause as far as
! 9 property damage. Ten millicuries of cesium, as an example, i 10. may not be a major health and safety concern if found by 11 someone on the street. However, that same source smelted in 12 a steel mill could cause millions of dollars worth of f
13 damage. Therefore, we felt from the property standpoint, 14 that that needed to be included.
15 In addition to this, we included certain specific-i 16 licensed devices. Basically these gauges were lower l 17 priority on the inspection scale currently; that is, five-18 year inspection cycle, may get bumped back to six or seven i i
19' years. We said this would be a more efficient way to )
l l 20 regulate these devices and ensure that they are actually l 21 maintained and controlled.
22 We looked at the resources that are currently used l 23 in the inspection program and said they could be used to !
24 actually maintain this registration system. These devices 25 have shown up at scrap dealers, steel manufacturers, both i
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28 1 specific- and general-licensed devices.
- 2 The meat of the program is more of a time factor.
3 Over time, if someone gets a device, they don't lose it 4 immediately. It's over time, five years from now. They 5 forget that they're a general licensee. They forget that 6 the device exists because the product line has been shut 7 down.
8 Therefore, an annual contact would again keep our 9 presence known, let them know that yes, you are a general 10 licensee, give them knowledge.
11 In addition, we found that the people who maybe 12 had the original general license are no longer with the 13 organization. Maybe they moved on in the organization and 14 this was very much a low priority in their annual duties.
15 Therefore, with this annual contact, it's a 16 remir. der. Let us know who your responsible person is. Let 17 us make sure they know they have a general license.
18 We also said from this registration we'd be able 19 to verify disposal, ensure it went to either a proper i
20 disposal site or back to a specific licensee.
21 And the last item that we felt was important to i
22 address but could not be addressed on a compatibility issue 23 with the states was the fee per device. We need to fund the 24 program somehow. The fee should come from the users.
25 States that have programs such as this in place i
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29 1 have indicated that it's better to do it on a per device 2 basis. It gives someone a reason to go out and check if 3 their device is there. Well, I'm not just going to send in 4 the check. I'll go check and make sure the device is here ;
5 first.
6 So it's an annual contact. Does the person still 7 have the device? Do they still know they are a general 8 licensee?
9 The second item we talked about in proposing 1 10 penalties, many people made the statement, you need to put 11 teeth into your program, and that was a statement made by 12 the stakeholders in the process. )
13 The penalty -- we said, as Bob has already 14 indicated, disposal could cost as much as $20,000 for one 15 device. If you're issuing someone a $2,000 civil penalty 16 when authorized disposal of their device could be $20,000, 17 that hardly keeps them from doing an unauthorized disposal.
18 Therefore, we said that the penalty should really 19 be based on what the authorized disposal would be. And 20 again, $20,000, that was for a 1 curie cesium source. There 21 may not be that many of those out there but it's an example.
22 For the states, the question came up earlier about 23 civil penalties. Again, we call it a penalty system in the 24 recommendations because states may need to do it in another 25 way -- administrative. Martha made many comments that she ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
30 1 is able to put administrative penalties on her licensees 2 that sometimes have much better effect than any type of 3 civil penalty she could issue to them.
4 We felt that the increased civil penalty was 5 justified based on one, the disposal cost but also the 6 consequences. As I said earlier, if you're talking millions 7 of dollars of damage to a steel mill and you're only 8 charging someone a civil penalty of $2,000, it really 9 doesn't have much of an effect.
10 The third item with the orphaned device, and we've 11 touched on this so I'm going to go quickly, is the fact that 12 no program could be 100 percent effective, so they're going 13 to exist in the future.
14 In addition, we've said there are 42,000 general 15 licensees, 460,000 devices. Many of these are already lost.
16 They were distributed over 20 years ago. We feel that they 17 may either be lost or waiting to be lost in a storage closet 18 somewhere, getting ready to go out with a load of scrap.
19 And again, we've talked about that, that we need 20 to get other agencies involved in this and basically make a ;
21 clear distinction of where the responsibility comes.
22 The question of what happens when someone finds a 23 device really needs to be answered, as well. It's 1
24 inconsistent across state lines. Some states will take l 25 possession of the device. Other states say, "You took !
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4 31 1 possession of it; you're stuck with it; you pay for the 2 disposal costs." Hardly an incentive for someone to state 3 that they have a device. What's going tu nappen? They're 4 going to just pass it along to the next person, 5 The last two recommendations are recommendations 6 for not NRC but really for NRC to pass along. NARM devices 7 have the same problems. We feel we should recommend to 8 CRCPD that all the states look at this and implement similar 9 programs for NARM.
10 In addition, nonlicensees, we have no jurisdiction 11 at this point. But if they're going to get a device, let's 12 give them information to educate them and allow them to 13 educate themselves, especially in the area of what do you do 14 when you find an orphaned device or any type of radioactive 15 material.
16 of course, the most important thing is probably 17 the cost of implementing the system, as well as the 18 benefits.
19 [ Slide.]
'20 MR. LUBINSKI: The next slide indicates a 21 " cost / benefit analysis" that we did based on $2,000 per 22 person-rem. I'm going to start with the costs first.
23 Initial set-up cost. The majority of this cost 24 goes into retrofitting the system. Again we're talking 25 'about going back,. finding devices. You may need to send ANN RILEY & ASSOCIATES, LTD.
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i 1 .
32 1.
1 inspectors out to facilities when someone says they lost a '
l'; 2- device or cannot' find it. :
l i
3 This is a one-time cost. If we elected to do this 4 over a three-year period, that is start'and do one-third of .
i 5 the retrofit and then the next third, it'could be amortized I i i 6 over three years, or however many years to do that.
I i
- 7 The annual operating cost again is based on a
{
t i '8 computerized registration system, the idea being here that ;
9 'with a compatibility 2 system you could not have one i
10 national database. You would need to have 30 different 11 databases. Even in a smaller state, this may be the most 12 effective way and we estimated a co.'t based on that.
l 13- Cost.to licensees, we feel, if anything, it may be !
14 a bit of an overestimate for the fact that-licensees'are ;
15 already required to do leak testing of devices. They're 16 already required to do servicing and maintenance of devices.
17 Therefore, to fill out'an extra piece of paper when they're 18 doing that to do their accountability and to make sure that .
19 they have an inventory record shouldn't be much of a burden. 4 20 The annual benefits were much more difficult to !
i 21 calculate in this case. Steel manufacturers -- we looked I e
22 here basically at property. We said that they're causing l 23 property damage, the devices, once they get into a steel i
24 mill. j 25 This is based on what we have at this point from )
J
}'
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l 33 i
1 small steel mills that have smelted devices, based on an 2 average cost of $8 million per device, which included 3 downtime of the facility. i 4 The reason we put "could approach" is that if we 5 cleared it up and never had another lost device, we could 6 say yes, we're going to save $12 million. The effectiveness 7 of our system we can't put an exact number on, to say that 8 it's definitely going to be a total of $12 million.
l 9 Exposure savings came from a report that was 10 provided to us by NRC. Pacific Northwest Labs did a report 11 and indicated that for cesium sources that are currently 12 used under general licenues, the exposure savings when 13 converted $2,000 per persor.-rem could be as much as $2 14 million. And that again is based on a population dose, tha
! 15 number of people involved, but, on ti.? average, co.1d be 16 about $14,000 per year.
17 CHAIRMAN JACKSON: Let me ask a question in t5rms l 18 of how those estimates were arrived at. Did they consider 19 the following three probabilities? The probability of loss 20 of the device, the probability of breach of containment and l
21 the probability of external or internal radiation exposure 22 for a given event.
l 23 MR. LUBINSKI: P&L considered those indirectly.
l 24 What they did is they went back and studied all cases where 25 incidents have occurred involving radioactive material ANN RILEY & ASSOCIATES, LTD.
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l t
34 1 getting into the public domain. Then they did an analysis 2 of that to determine what were the most likely 3 representative cases of people being in a proximity to the ;
4 device and the time they were in that proximity.
5 Based on that information they looked at what the 6 internal dose would be, as well as the external dose, based 7 on cesium sources, those numbers.
8 From the limited amount of data that P&L did, they i
9 were within an order of magnitude on their estimates. From 10 a limited number of cases -- I don't have the number they 11 looked at -- what they'd indicated is it was a good enough 12 estimate that they thought additional work in this area, 13 with time and proximity factors, should be performed. At 14 this point this was what they called a preliminary estimate 15 for cesium sources.
16 That concludes the Working Group's recommendations 17 and report. At this time what I'd like to do is ask Rita 18 Aldrich to provide her views on the report. Rita was 19 involved in some of the meetings of the Working Group.
20 CHAIRMAN JACKSON: Am I understanding this is 21 going to take about 10 minutes?
22 MS. ALDRICH: Yes.
23 MR. LUBINSKI: I just want to note that Rita was i
24 not involved in the final writing of the Working Group 25 report. Therefore, Rita submitted a separate letter to the ANN RILEY & ASSOCIATES, LTD.
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. _ - . . ._ , _ . . ___m._-_______. . . _ . _ . _ . . . _ _ . _ _ - __ _
l l
35 l
- - i l' Commission stating what her views were and she's going to go 2 over those now, i 3 MS. ALDRICH: Some of what I have-in my overheads 4
we've gone through already some I'll kind of_ whip through l 5 them.
6 One of the basic premises that we were working L
7 with from New York's perspective, we've had a steel mill in 8 .New York that's melted two sources, the same mill, l
l~ 9 unfortunately, at 10-year intervals and it's cost an awful 10 lot of money. So this is a topic that's very close to --
11 CHAIRMAN JACKSON: Do these mills put any kind of 12 detection devices?
13 MS. ALDRICH: Yes. After the first smelting, the 14- mill put in a portal monitor. After the second smelting, l 15 the mill has also put in a monitor at the scrap bucket, so
! 16 it'll be looking at smaller quantities.
i 17 But the monitor was working when the second source l
18 was received and it didn't necessarily protect them from it.
19 If it comes in in the middle of a load of scrap and it's in l 20 it containment, the monitor won't pick it up, if it's in its 21 original shielding. So they do the best they can but it 22 doesn't mean that they're always going to be able to detect l
- 23. them.
24 In my opinion and in our opinion, I guess, in New 25 York, the general licensing of sealed sources and devices is i
a I
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36 ;
l 1 a basically, flawed concept. It tries to establish a middle * '
2 ground between exemption and specific licensing. And it l i
3 fails because, in essence, it results in too little control ;
4 of hazardous sources -- curie quantities of cesium sources,- !
5 500 millicuries of americium, things on that order. I 6' And it invites overregulation of sources that !
7 don't pose a realistic hazard if they're lost or stolen, I 8 such as microcurie quantities of beta emitters in small 9 gauges.
'10 We regulate them all right now as if they had 7 11 equal hazard. As long as we continue to combine sources i 12 with such different hazards in one category, we can't solve !
13 the present problems. Any increase in regulatory oversight 14 on the GLs will just_ shift the imbalance a bit, continue the 15 underregulation of the hazardous sources and the ;
16 overregulation of the less hazardous sources. L 1
17 Our proposed solution was to divide the general j 18 license into those'that should be specifically licensed and !
19 those that should be exempted preferably from regulation 20 because what we're doing right now is not adequately 21 regulating anything in the group. j 22 We differ from the Working Group in this respect. {
23 This is sort of a fork in the road here. One of them is to i
24 say, well, we'll take the general license and we'll try to j i
25 improve it. The other is to say that the general license j l
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- 1 37 {
i i
1- .hasn't worked for these more serious sources and that we ;
i 2 need to go to another system that we have demonstrated does i 3 give us adequate control. l t
4 The states have complained about the general l r
5 license for quite a while and at one of our meetings an old i 6 memo from --~I'm sorry; I haven't called for-any of the !
1 I
7 slides. Excuse me. We're now on the fourth overhead. Oh, i 8 it is up there.
9 At any rate, this is excerpted from a 1981 memo, l
10 so this concern goes back quite a ways. And in the memo it ;
i l
11 states that at a recent All Agreement States meeting, which j 1 t 12 is an annual meeting between NRC and the Agreement States,
! 13 the states commented that "NRC should reevaluate the GL l l 14 device distribution licensing concept and seriously consider )
! i 15 rescinding the GL concept of licensing gauges." '
16- [ Slide.]
17 NS. ALDRICH: The next slide is just the second 18 part ot that memo and just goes on to say that the states 19 have seen a number of incidents involving this use of GL 20 sources and'it would be beneficial to discuss this. Next l
21 overhead, please. !
22 [ Slide.)
23 MS. ALDRICH: If an agency has a problem with a !
24 class of specific licensees -- that's the case in which you
! 25 have issued a specific document to a specific company, i
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\
l
38 1 .they've applied for a license, they have made commitments 2 ahead of time, they've told you who the radiation cafety 3- officer is going to be -- if you have a problem after the 4 license is issued, you use the specific license as a way to 5 address the problem.
- 6. It must be issued before the sources can be 7 applied. It must be amended if the person responsible for 8 radiation safety changes. It must be periodically renewed.
9- Next overhead, please.
10 The proper control over and disposal of sources 11 are the subject of periodic inspection of the licensee.
12 Improper disposal of all sources must be proven before the 13 license can eventually be' terminated.
14 And a question that the Chairman had asked a while 15 ago about nonmonetary penalties,.the specific license also 16 .gives you a way to impose nonmonetary penalties. You can 17 amend restrictively the license, you can suspend the 18 license, you can make them put all sources in storage 19 because you think they have an accountability problem, or 20 you can revoke the license for cause.
21 So with a general license, there's no way to do 22 that. It's given in the regulations. You have no control 23 over -- it seems to me, at any rate, you have no control
'24 -over the person after they acquire the source.
25 The philosophy behind the regulation of GLs is ANN RILEY & ASSOCIATES, LTD.
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39 1 very different from the specific licenses. The sources can 2 be acquired with no prior-approval by a regulatory agency,
- 3 by any company or person that can afford them.
- 4 I also think it's important to think about what a 5 company might think if they can order a source, to them, a 6 gauge -- they don't think of it as a radioactive source --
7 out of a catalogue and receive that with no prior regulatory 8 questions or approval? How much of a hazard are they going 9 to regard that object as presenting? Very little, it seems.
10 And I think that in that sense, we're failing 11 because in making it that easy to acquire something that is 12 hazardous, could cause a very extensive personal property 13 problem, we are sending that message, that this isn't that 14 important.
15 So in the absence of issuing a specific license, 16 there isn't any prior designation of a radiation safety 17 officer, there's no licensing document that can be used to 18 enhance control, there are no periodic inspections and 19 almost complete reliance on source vendors for the records 20 of receipt and disposal.
21 Basic inequities -- overhead, please. Specific 22 licenses, and very often there's no difference between a 23 specific-licensed gauge and a generally-1 _ensed gauge of 24 the same activity, except for the labels. You can get a 25 curie under one kind of licensing or a curie under another ANN RILEY & ASSOCIATES, LTD.
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40 1- kind of licensing. It's cesium 137 and it's a curie.
2 There's really vr;ry little difference between them in many 3 cases.
4 But the specifically licensed ones are subject to 5 all' code' requirements. Many of our code requirements really 6 don't make sense for a simple type of license like this.
7 On the other hand, the GLs, as.they're currently 8 regulated, are exempt from everything except the few 9 requirements in the segregated part of the regulations, plus 10 requirements for proper disposal.
11 And keep in mind that the only knowledge that the 12 general licensee has of their requirement very of ten is what 13 the vendor tells them about because they're often not 14 contacted by a regulatory agency. In New York we have. l i
15 always registered GLs and we require them'to do semi-annual -
16 inventories. We're working.towards the point where we're 17 going to have them on a database so that we can contact them !
i 18 on a regular basis. !
i 19 But because of the concept that they've always 1 l
20 been a different kind of animal, they've never been recorded 21 on computer, at least in New York. We kept paper records, i
-22 so now we're creating -- in the last few months we've been 23 creating a computer database so that we can regulate them 24 more effectively with direct. contact.
25' The specific-licensed fixed-gauge licensees, our ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 i
41 1 experience with them -- these are the equivalent or the i 2 parallel to the generally-licensed gauge licensees -- that 3 they perform as well as any other licensee of ours, as long 4 as the same degree of regulatory oversight is exercised.
5 I agree that we need to look at our resources.
6 Next overhead, please. We need to reexamine how our 7 resources and our licensees' resources are being used to 8 regulate these various objects. As I said before, many of 9 the GLs are similar or identical to the specifically-10 licensed items.
11 Our conclusion in New York is that we are :
12 underregulating the GLs and overregulating the SLs and our 13 experience demonstrates that we can achieve good control of l
14 both with a few basic concepts. Next overhead, please, j 15 One is to require a licensee commitment to 16 oversight of sources and proper disposal before the sources 17 are allowed to be acquired. There will be companies that 18 won't choose to undertake the responsibility and may not 19 wish to look at the down-the-line cost of disposal. I think 20 that should be an up-front decision. You can't have that 21 unless there's some previous contact and explanation on the 22 part of the regulatory agency.
23 Second, require the licensees to maintain good 24 records of receipt and disposal and of current source l 25 inventory. Next overhead, please.
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42 1 Third, require prompt notification to the_
2 department of loss of control of a source. Four, regularly 3 scheduled inspections. These, don't have to-be lengthy.
4 Ours we're trying to keep to an hour. We have a four-page-5 form. It just hits the high topics. Basically, where's 6 your inventory? They'll spot-check what you have in the 7 facility against your inventory because an inventory, by 8 itself, is worth the paper it's written on unless you have 9 some confidence that it reflects the reality in the 10 -facility.
11 And regular license renewals to reinforce the 12 licensee commitments. I think one of the important concepts
'13 is that the recipient of one of these gauges makes that 14 commitment up front that they're prepared to care for it, 15 that they're prepared to pay eventually to dispose of it, 16 that they're going to do all of the check tests and leak 17 tests that required.
18 So what I am suggesting is that to conserve 19 resources, that we can do a streamlined version of a license 20 to cover both the generally-licensed and the specifically-21 licensed sources that fall into this category of concern, as 22 I think we're calling them. We can guarantee 10-day 23 turnaround. We have a mini-license application form that's 24 four pages long, not too onerous.
25 It explains what the responsibilities are. It ANN RILEY & ASSOCIATES, LTD.
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43 1 requires the licensee to enter just the basic information -
2 - their name, their address, who's going to be the radiation 3 safety officer, the person responsible for carrying out the 4 radiation safety responsibilities. I think it can be done 5 at least as cheaply as what's being proposed in adding some 6 refinements to the general license, but I think it gives us 7 the essential concept, which is that we have contact with 8 the applicant before they receive a source over which we are 9 concerned and we would like them to be concerned.
1 10 That's really about it. Thank you. ;
11 CHAIRMAN JACKSON: Thank you. I just have one l
12 last follow-on question. If I look at the recommendations 13 that the Working Group made, and to the extent that you want 14 to comment on Ms. Aldrich's recommendations, you mentioned 15 the suspended rulemaking; to what extent were any or all of l
16 these recommendations addressed at that earlier rulemaking? j 1
17 MR. LUBINSKI: The first comment is that Ms.
18 Aldrich's letter that she'd sent in -- the Working Group
]
19 hash all seen a copy of a letter. As a Working Group, the 1 20 Working Group has not gotten together and commented on the 21 report, so I think at this point we don't want to have any 22 comments except to say that many of the conclusions or bases 23 for what Rita has stated are the same as what the Working 24 Group says.
25 From the point of the suspended rulemaking, the ANN RILEY & ASSOCIATES, LTD.
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44 ,
{ 1 current rulemaking that was in place in 1991, that'is, the 2 proposed rulemaking, besides the registration system, did L
3 have-some other essential elements'that are needed for the j 4 program and are things that we basically addressed.
l t 5 For example, providing disposal information to a l
i f
6 licensee up front, that was included in the rulemaking.
7 Tying up some loose ends cn1 what a general licensee can do 8 and what they should do, such as inventory systems and 'i 9 disposal of devices and providing proper-notification of ,
10 ' disposal.
11 However, the way the current rulemaking is set up, ;
12 it only addresses generally-licensed devices. We felt that 13 was one shortfall of the current rulemaking.
14 The second would be the current rulemaking was )
15 designed to address all general licensees. However, the 16 wording in the rulemaking is not such that it would require 17 all general licensees to comply with the registration ]
18- program. It put the burden on NRC to contact.the licensee. !
19- The burden on the licensee was to respond to NRC and 20 . requests for information.
21' So the implementation could be modified; however, 22 the proposed rulemaking that did go out addressed all
- 23 general licensees and told the public that's what we were 24 going to do. What we would have to do to revive that would 25 be an issue.
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- t ;
.ls 45 :
i i
1 .However, the fee situation would need to be !
< i
. t i 2 addressed as part of~that, as well. The current rulemaking, ;
3 with it only applying to licensees responding to NRC l
4 requests, may have some problems in the fee area. You're i i
g^
5 trying to collect fees from someone at that point and set up I i
j 6 an equitable billing system for those types of licensees.
i f
- 7 So we did look at the rulemaking. We pulled the !
t !
8 parts out that we thought were good and we agreed with that l i- i l 9 along our process. However, from this standpoint we would i 1- !
I 10 -probably recommend that new rulemaking be developed along 11 .the same lines that would include specific licensees and I 12 would clearly' address just those devices that we're .
-13 concerned with in the regulation, not as a policy issue.
14 CHAIRMAN JACKSON: And what about this issue of j 15 equity of treatment of general licensees and specific i 16 licensees?
i 17 MR. LUBINSKI: We feel that the equity would take l 6
18 place in that case with the class of general-license we're i 19- concerned with because we would also recommend the specific I
- 20. licensees that are doing the same operations. As Rita said, 21 some devices are identical except for the labeling, whether ,
22 they're used under a specific or general license. If you !
23 put.them into the same registration system, they would be
- 24. treated equally. !
25 Currently,.many of these are gauge licensees with ANN RILEY & ASSOCIATES, LTD.
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46
~
1 prior number 5, which is inspection every five years.
2 Instead of going through that type of method, instead, put 3 them under a general license. Make that the requirement, l
4 that they're under the general license registration system.
5 The general licensees that we did not address --
6 that is, exit signs, chromatographs -- we, at this point, 7 would say we don't see where we would need to look at those.
8 Maybe in the future, as an expansion of the general license 9 registration system, it may be something to consider, but at i 10 this point we would say leave them as they are.
11 If you want to say there's inequitable treatment 12 between them and the current SLs, there probably is, from 13 the standpoint of fees and the amount of oversight.
14 However, it is valid based on the risk associated with each -
15 of those devices -- during use, during accident conditions, 16 and during loss conditions.
17 CHAIRMAN JACKSON: I guess I'm really more 18 referring to specific licensees and general licensees who 19 may de facto have the same kind of device.
20 MR. LUBINSKI: We would say put them under the 1
21 same registration system, and that's part of our 22 recommendation. Put them under the same criteria, same fee l l
23 system, same system of requirements and take them out of l 24 their current licensing system as we see it and the current 25 inspection system that they're under and put them into this ANN RILEY & ASSOCIATES, LTD.
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~
47 1 registration system.
2 CHAIRMAN JACKSON: Commissioner Rogers, do you ,
3 have any questions?
4 COMMISSIONER ROGERS: No.
5 CHAIRMAN JACKSON: Commissioner Dicus?
6 ' COMMISSIONER DICUS: Yes, one quick one. You said 7 that you thought that the cost of what you're proposing or ;
8 what the State of New York is proposing is about the same as 9 what the Working Group is proposing and I wonder if you had 10 actually run the numbers on a cost / benefit basis.
11 MS. ALDRICH: No, we haven't, but I think that 12 what the Working Group is starting with is really kind of 13 soft numbers. I'm jast thinking of it qualitatively in 14 light of what actions you'd be taking. You would have a 15 one-time contact with the applicant in the licensing 16 process. The basic requirements would stay the same. The 17 other activity that would require time and money would be 18 this annual contact. I'm not sure that that's absolutely 19 necessary if you put them on a regular inspection schedule.
20 There are a lot of differences between what the 21 states do now and what NRC is doing. Our fixed gauges are 22 inspected on a three-year interval. They're quick l 23 inspections but they're there. You get there and show the l l
24 flag so that they know that you exist and that you're 25 actually going to look at what they have.
i' l ANN RILEY & ASSOCIATES, LTD.
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48 1 I'm in complete disagreement with saying we're ,
2 going to equalize the playing field by taking these fixed 3 gauges we now specifically licensed and put them into a 4 level of control that I consider to be inadequate as it 5 stands, even with the improvements. To me, this is 6 illogical. We're going in the wrong direction.
7 CHAIRMAN JACKSON: Commissioner Diaz?
8 COMMISSIONER DIAZ: Precisely that was my point.
9 It seems to me like we might have an issue of concern that l 10 although it might have little health benefit impact right >
11 now, it could have at any one point, in any one area, become ,
12 an issue, like it has happened in other places in the world. i 13 And putting the system on the same basis seems to 14 me like it would be actually decreasing control, rather than 15 if we're going to go to a registration system, have a i 16 registration system that's very specific and designates 17 which isotopes according to those and according to a risk 18 basis analysis, which ones should actually be done.
19 MR. LUBINSKI: I would argue the point of less 20 efficient system going under a registration and the reason I 21 would say that is there's one aspect to the registration 22 system that we currently don't have under a specific 23 licensing program. When a specific licensee is inspected, l
24 we can check records of transfers at that facility but 25 there's really no cross-check done against what a ANN RILEY & ASSOCIATES, LTD.
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i 49 1 distributor may have said.
2 So with the registration system you would have a !
3 real-time, per device check of what a licensee has. -You l 4 would get the reports from the distributor that says a !
5 licensee received a device. When you did your annual I 6 contact you could specify that device by serialarumber, 7 verifying that it is indeed there.
8 When you go to someone's facility every three ,
i 9 years, every five years, and you look back at some of the ;
i 10 records, the license may say you can have any type of 11 gauging device containing cesium, americium or cobalt. You i
12 don't know, as an inspector when you go there, exactly what j 13 devices are supposed to'be at that facility until you look !
14 at transfer records at that facility.
So if the licensee does not have the transfer 15 i
16 . record that he received it, you're not going to look for the' !
17 device. Therefore, you never check to see if the device was l
18 there. Through the registration system you can do that I
'19 cross-check.
l 20 COMMISSIONER DIAZ: But taking a devil's advocate 21 position, what is the incentive for a licensee to switch 22 -from a general license to a specific license or l
-23 registration? It's always the fact that it will be more 24 economical to be under the general license and that could 25 actually be a fact that would deregulate them, rather than 5
^
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4 50 1 increasing regulation.
2 MR. LUBINSKI: That would be something, as far as 3' the costs we could see, as being a benefit to the licensee 4 that would push them to say yes, I'd rather be under the 5 registration program rather than the specific licensing 6 program.
7 We also considered the -- and I'm going to use the 8 word inequity again -- when we're talking about the exact 9 same device being used under either a specific license or a 10 general licenae and it being the choice of the recipient.
11 They decide how they want to use it.
12 If they are only using it and possessing it and 13 not doing any additional services to it, we would say that 14 we should structure the program such that they are required 15 to have it under this registration system. !
16 If, for other reasons, such as they want to have ;
17 training and be able to do servicing of that device, now 18 they say they want to put it under the specific license 19 instead, well, now we're dealing with someone who has a 20 -higher level of training and knowledge of the consequences 21 in dealing with this device.
22 But if they're just dealing with the straight 23 possession and use of the device, we would look at that as 24 being in the regulation as a requirement to go under the 25 registration system.
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_ _ _ _ . . _ . . _ ~ _ _ _ . -
51 1 CHAIRMAN JACKSON: Commissioner McGaffigan?
2 COMMISSIONER McGAFFIGAN: Could you comment on the 3 1 millicurie standard that Ms. Aldrich is proposing as the 4 category of general licensees that we would think about 5 moving to specific license, the amount of activity that 6 would relate both to the industrial problem and the public 7 health and safety problem. Is that in the right ballpark, 8 from your perspective?
9 MR. LUBINSKI: It is in the ballpark. If you look 10 at the numbers that the Working Group proposed, we were 11 talking 1,000 times the exempt quantities in Part 30, which 12 would range anywhere from .1 millicuries up to 10 13 millicuries, depending on the isotope, and we also picked a 14 1 millicurie for the transuranics, which were not listed in 15 the exempt quantity table. So we're in the right ballpark.
16 As far as the different types of isotopes, ve had 17 determined -- that is, the Working Group had determined --
18 with the input from the stakeholders, which isotopes should )
i 19 be included based on what the effects would be if lost, 20 handled by members of the public, in addition to making it 21 into a steel mill or a scrapyard and causing damage to 22 property.
I 23 Miss Aldrich indicated that she was looking at the 24 gamma emitters -- is that correct? -- 1 millicurie --
25 MS. ALDRICH: And the transuranics.
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)
52 1 MR. LUBINSKI: And the transuranics, so we're very 2 close right there. We're talking cobalt cesium; she's 3 talking all gamma emitters. Our strontium we felt needed to 4 be added more for the health and safety risk if it is lost, 5 because of the high doses someone could get.
6 This was' based on experience of the members who 7 are involved in these working sessions, members of the 8 -public as well as licensees on their experience.
9 To say that we did a risk assessment at that 10 point, it was a type of risk assessment, but very much along 11 the lines of disposal problems, half-life of the isotopes, 12 internal and external exposures, as well as cost of damage.
13 So it's not far off when you talk about this 14 category.
15 COMMISSIONER McGAFFIGAN: I might ask Ms. Aldrich, 16 what is the matter with the isotope-specific range that 17 they're talking about as an approach?
18 MS. ALDRICH: I don't think it brings us any more 19 precision because as John said, we're still just making 20 qualitative comparisons. I think it's preferable to keep 9
21 things simple and not to pretend to precision that we don't 22 really have. That's all.
l 23 So I would prefer the 1 millicurie across the 24 board, making it easier for everybody concerned, both the 25 recipients and the manufacturers.
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i 53 l 1 CHAIRMAN JACKSON: Although, in fact, the kind of l 2 emitter you have relates to what the biological damage is. '
l 3 Is that not correct?
4 MS. ALDRICH: Well, we're talking about sealed l
l 5 sources and I have no incidents in New York, at least, that 1
6 I can recall where the sources themselves were breached.
7 They're very sturdy. So we're talking about external dose, 8 so it seems to me that a millicurie is precise enough.
9 CHAIRMAN JACKSON: I think we'd better move along l
10 and hear from the staff. Thank you very much.
11 MR. LUBINSKI: Thank you.
12 CHAIRMAN JACKSON: Mr. Taylor?
13 MR. TAYLOR: The staff will now give its 14 preliminary views based upon what was in the SECY paper.
15 This will be given by Don Cool.
16 DR. COOL: Good afternoon. I'll try to move 17 things along quickly. We'll go ahead and go to slide 2.
18 [ Slide.)
19 DR. COOL: Just a couple of observations with -
20 regard to the risks. When you talk about the category that 21 is generally licensed today -- all the devices, all that 22 entire range -- under ordinary conditions, those kinds of 23 devices do not represent a high risk to health and safety.
24 That's the kinds of environments that they were particularly l 25 designed and used for.
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54 1 For the majority of those devices and, as we saw
- 2 earlier in the Working Group slide which had the pie chart 3 on the kinds of devices, exit signs and a variety of things, 4 even most of those, the vast majority of those under 5 accident conditions, loss conditions and otherwise, don't 6 pose a significant hazard, even if they are lost and out 7 there in the environment.
8 However, it is true that some of those devices do 9 not account for the radiation exposure, property damage.
10 That's an area which this agency has not looked at in terms 11 of assessing public health and safety. We've looked at it 12 in terms of dose. We've looked at it in terms of the 13 collective doses and risks in a traditional sort of analysis 14 in terms of a regulatory analysis that would be done with a 15 rulemaking.
16 Heretofore, rightly or wrongly, property damage 17 and some of those issues associated with a nonhuman health 18 effect type of analysis have not been considered as part of 19 the activities.
20 [ Slide.)
21 DR. COOL: Basically, the options -- next slide --
22 that we look at fall into sort of three major types of 23 categories. We could maintain the status quo as it 24 presently exists today. You could go back and simply 25 reinitiate and move forward the rulemaking plans and ANN RILEY & ASSOCIATES, LTD.
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55 1 activities that were in place a couple of years ago, ,
2 recognizing some of the resource considerations that were 3 associated with those. Or we could, as a third option, go 4 back and take a look again at those rulemaking activities 5 but attempt to readjust them in light of what has been '
6 learned with the Working Group report, some of the other 7 activities, and some of the other issues that have arisen.
8 If I can go ahead and go to the next slide.
9 CHAIRMAN JACKSON: No, not quite.
10 DR. COOL: Okay. Trying to keep it moving.
11 Sorry.
12 CHAIRMAN JACKSON: If you're assuming you're 13 tracking to option 3 --
14 DR. COOL: I am tracking to option 3 on the next 15 slide. l l
16 CHAIRMAN JACKSON: What further evaluation do you 17 need? How long would it take to develop such an action 1 18 plan? And when would it be finished, with the existing 19 resources?
20 DR. COOL: That's exactly what I hope to address 21 in just a moment, if I can. j l
22 CHAIRMAN JACKSON: Good. Okay.
23 DR. COOL: Because the answer to that depends on
)
24 the component of the action. For some of it, in terms of I
l 25 moving forward, I think we can move forward on a couple of i ANN RILEY & ASSOCIATES, LTD.
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56
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1 fronts relatively quickly.
2 The rulemaking that was previously on the books, 3 as the Working Group indicated to you, was a rulemaking that 4 covered all generally licensed devices. In retrospect, in 5 looking at the hazards associated with those devices, that's 6 probably not necessary. We really don't see just simply 7 attempting to go forward with that with all of the 8 implications that would be associated with that.
9 On the other hand, as they also noted, it doesn't 10 deal with some of the inequities and some of the sources 11 that are out there under a specific license category, which 12 are really kinds of identical sources.
13 And what we would like to do is go back and look 14 at it in terms of reracking the entire system. Here I think 15 perhaps we have maybe a slightly different view from the 16 Working Group that might actually end up sounding a little !
17 bit closer to where Ms. Aldrich was in the sense that rather j 18 than perhaps being still considered a generally licensee 19 that you would, in fact, create what would amount to perhaps 20 a fourth category right in the middle which bears some of 21 the characteristics of a specific license, in terms of 22 contacts, in terms of fees and billings and other sorts of 23 things, but which was a much simplified process and which 24 perhaps might involve a different kind of touch, if you 25 will, to the licensee.
]
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57 1 If the issue, as the Working Group pointed out, 2 was a matter of contact and accountability, we believe you 3 could achieve that through an annual sort of registration 4 approach where you ask them to certify certain things. You 5 ask them to provide points of contact. You ask them to 6 certify that they've, in fact, done a proper leak test, that 7 it has the right kind of signage, that they've eyeballed it, 8 they have inventory control over the thing, that they 9 provide evidence of disposal if they have disposed of the 10 device, and limit perhaps then an inspection program to 11 those situations where you don't get back a satisfactory set 12 of answers to that.
13 That, in fact, would be more like a variation of a 14 specific license than a registration of a general licensee, 15 although the semantics get to be rather fine, depending on 16 how you particularly cut the process.
17 We believe that we could probably move forward to 18 put some of that in place and start to test the system. One 19 of the things I think we're trying to learn here is that you 20 don't try to go and conquer the entire universe in one large 21 bite chunk. Certainly some of the' states have done it and 22 there's been some different approaches which the states have 23 used.
24 As part of our business process reengineering 25 going along on separate tracks, we've been looking at some ANN RILEY & ASSOCIATES, LTD.
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t !
! 58 1 of the ways that people have been doing registration and l .
L 2 licensing in other sectors. And, in fact, there are federal :
l !
- 3 agencies out there who issue enormous numbers of licenses -- !
4 the Federal Communications Commission -- who use processes l 5 like this and, in fact, have systems already developed, 6 which we may be able to take advantage of. [
7 Our proposal would'be to try and implement and try I 8 and implement within the next year a test pilot, our thought ]
9 being perhaps those generally licensed devices which were 10 distributed in the last year or perhaps 1995 and 1996. That !
11 would be something on the order of 1,000 gauging devices. .
12 CHAIRMAN JACKSON: How would you limit the sample?
i 13 DR. COOL: Test the system. That has a couple of !
14 advantages as we see it, just in our preliminary thinking, 15 in that those are most likely to be the ones which we'd have 16- the best records on, the most recent records on, and the 17 fewest number of those that we won't find on the first pass 18 because the real issue, as has been pointed out a couple of 19 times already, where you really get into the resources is !
20 how long and how far and how many times do you chase the f 21 device that doesn't come back when you sent that letter to ;
22 XYZ locality and it comes back undeliverable, no person P
23 here, don't know what you're talking about. Then you maybe 24 get the standard sort of skip trace. i 25 From there you start to send out inspectors and i ANN RILEY & ASSOCIATES, LTD.
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59 i 1 how far down do you pursue those, recognizing, as the 2 Working Group indicated, that there are some which are 3- already lost. They are sitting in somebody's scrapyard 4 someplace and the only way those will ever be found is.if 5 they show up on a detector sometime as the metal continues 6 to move about the process.
7 So we believe we could move forward relatively 8 rapidly in that arena. '
9 Likewise, we would like to go ahead and start 10 moving forward to revise the rulemaking, move that into I 11- production, to address some of the issues that have been 12 dealt with here, to look at a rerack of the system -- that l
13 is, to take some of the things which are specifically l 14 licensed now and put them into this new category, to put in !
15 some new requirements with regard to looking at property ,
1 16 damage in terms of an evaluation. It-will take some period j l
17 of time and almost certainly require a reproposal of the 18 package, rather than simply bringing back the package that 19 was brought up before.
20 That has a probably two-year time frame for total 21 completion of analysis, proposed rule, public comment 22' period, _ final' analysis and bringing those sorts of things 23 closer.
24 CIAIRMAN JACKSON: Two years from now?
25 DR. COOL: Roughly two years or so from now, given l
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60 1 those sorts of circumstances.
2 CHAIRMAN JACKSON: And how long a test 3 registration period would you be having, a pilot test 4 registration?
5- DR. COOL: Off the top of my head, and this is 6 only_the preliminary planning, I'd like to get that in place 7 within the next year, run that for a year and start the 8 expansion the year after that.
9 _ CHAIRMAN JACKSON: Let me just get to the bottom 10 line. If we don't push you, when would you have come back 11 with a plan?
-12 DR. COOL: I would have come back with a plan 13 within a few months.
14' CHAIRMAN JACKSON: Okay. You've had the Working 15 Group report since July, correct?
16 DR. COOL: That's correct.
17 CHAIRMAN JACKSON: So a few months, meaning the 18 beginning of next year, with a plan?
19 DR. COOL: With a plan. And --
-20 CHAIRMAN JACKSON: If we don't push you on it.
21 DR. COOL: And if this Commission would give 22 approval, that plan would indicate when the test would
- 23. actually be getting off the ground.
24 CHAIRMAN JACKSON: Commissioner Rogers?
25 COMMISSIONER ROGERS: No, I don't think I have any ANN RILEY & ASSOCIATES, LTD.
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61 ;
1 questions.
2 COMMISSIONER DICUS: I'll wait. No, I do need to l 1
3 ask it.
I 4 You are going to do these at the same time but i 5 some of the information you get out of registration is going 6 to be necessary for the rulemaking, is it not? It seems I 7 like the two are not necessarily tracking together, is my 8 point, that the registration program, I think you said 1 9 upwards of three years, and, if I heard you right, on the 10 rulemaking, maybe two years. Now, maybe I'm missing 11 something.
12 CHAIRMAN JACKSON: Yes, how does one inform the 13 other?
14 DR. COOL: Preliminarily, if we were to have a 15 registration running by the time you got to the comment 16 period, within the next year or so, then you could be 17 gathering data in that year which could also inform a final 18 rulemaking activity, l
19 What I meant to imply was that in the third year I 20 you could then be looking to move it, with the rulemaking 21 final, towards those specific licensees, to bring them into 1 22 part of the program if you wished to do that, and to begin 23 to go back, depending on how far back and how much resource 24 you want to put in it, to capture previous years, '94 and 25 '93, the older cases.
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62 1 So I believe roughly they could time-out. Part of 2 it would depend on the speed with which the rulemaking 3 activity could proceed and the speed with which we could get 4 a first cut registration system off and get them signed out 5 and see what kind of response we got.
6 CHAIRMAN JACKSON: Commissioner Diaz?
7 COMMISSIONER DIAZ: I'm probably a little confused 8 but let me see if I can express my confusion. We seem to be 9 always worried about a series of sources of radiation to the 10 public from many things and our ontrol or lack of control 11 over them. Here we have in a specific case, hundreds and 12 thousands of sources which we have been dealing with for 13 many years, and I think we have now concluded that we need 14 to take additional action on it.
15 I haven't seen, and maybe it exists and maybe v.-
16 have done it, what is an overall risk assessment of all of 17 these sources, static and moving, in this country, and what 18 is the potential for any of those sources, in the curie 19 range, for example, to really have an impact on health and 20 safety?
21 Second, I didn't see a staff number of how much 22 would be the incremencal cost to put a program that would 23 actually, in a short period of time, address the issue. I 24 think the issue has been standing around and it might very 25 well be that it's an issue of resources. I think that we ANN RILEY & ASSOCIATES, LTD.
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i 63 j 1 should consider addressing the issue in as short as possible !
i 2 time.
i t
l 3 So I have a statement, that being about risk j i
4 assessment, and cost and implementation. l 5 DR. COOL: Okay. With regard to the first piece l 6 of it, we do not have a formal PRA or similar risk analysis i
7 which addresses all moving or static sources within the l 8 United States, as I think you have outlined. What we do li 9 have is the operational experience here in the United j 10 States, which indicates that we have not had significant i
-11 sources which have caused major exposures to the population. ,
12: COMMISSIONER DIAZ: You mean you believe you have i 13 not had significant exposure. l 14 DR.. COOL: The data which we have available -- {;
15 COMNISSIONER DIAZ: The data which you have j i
16 indicates that but you're not sure that you have not.
17 DR. COOL: I would have to say that I do not l 18 believe that there have been significant exposures of !
19 individuals within the United States.
l 20 COMMISSIONER DIAZ: The data indicates that there 21 1s -- l i
22 DR. COOL: That's correct. l
! 23 COMMISSIONER DIAZ: Okay.
j_ 24' DR. COOL: With regard to the second case, actual' l 25 costs, the previous cost estimates in FTEs are probably not i-ANN RILEY & ASSOCIATES, LTD.
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64 1 bad in terms of what it would take to try and move 2 relatively rapidly and to try and recover, to the extent 3 that you could recover and recapture sources which are out 4 there and which you can find.
5 Our reason for trying to move in a pilot test in 6 terms of the system and then to bring it on line is really 7 driven by two purposes: one, to make sure that what we 8 develop will work before broadening it and two, to gain some 9 experience with the capture rate for those that we believe 10 the capture rate should be low on, and to gain some measure 11 of understanding of how far we would wish to push the topic 12 of pursuit.
13 I really believe that the issue of the resources 14 that the agency would spent is really a function of, from a 15 policy standpoint, how far and how long we wish to pursue 16 old sources which we could not find, recognizing that there 17 is some number of them which we will never find except as 18 they show up on a portal monitor or a scrap line monitor 19 within the actual systems.
20 COMMISSIONER DIAZ: Should we reduce the 21 uncertainty that surrounds the issue?
22 DR. COOL: You're trading those off. That's 12 3 correct.
24 COMMISSIONER McGAFFIGAN: I may also be confused.
25 It strikes me that the test program you're proposing, it ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034
i 65 -
L* 1 isn't really a very good test because it's the part'that we !
2 understand, you know, the devices that have been distributed .
l 3 .in the last year or two, whereas the problem is those '
4 things -- it strikes me that a better test would be to go to {
5 find everything half a curie and above that might have been l i
6 generally licensed ever. I don't know how many of those -
7 there are. I'm just making that up, but that's a real test. ,
t 8 That would tell us how hard it is to find, how [
9 many things we're going to have to go beat the bushes to try :
10 to find, whether there's a real concern. But the test i i
11 program doesn't sound to me like it's going to tell me ;
i 12 anything, other than we can find what was done in the last '
13 year with close to 100 percent accuracy without very much }
14 sweat.
l 15 CHAIRMAN JACKSON: And it's not necessarily i
16 referenced to public health risk i l
17 COMMISSIONER McGAFFIGAN: Right. !
18 CHAIRMAN OACKSON: Which is what our jobs are.
19 COMMISSIONER McGAFFIGAN: So my big problem with i 20 this, and I join Nils in not understanding, is if the l 21 concern is -- and I also differ -- I got the briefing a week 22 ago from Joel and there is a Texas case where one of these L 23' devices ended up in a home and people were exposed to decent 24 exposures. Wasn't that in Texas?
25 DR. COOL: I believe what you're referring to is i
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__ m _. .- _ _ . _ _ _ - _ _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ _ _ _
i
, 66 ;
1 what we refer to as the Larpin event, which was a !
l 2 radiography camera, specifically licensed, in fact, under s
3 relatively tight control. Texas was swinging by every few l 4' . weeks-and the device was stolen.
5 l
Sk) it doesn't really exactly fit the mode that i 6 we're talking about here.but it certainly demonstrates what 7 happens when people sort of forget and other things happen 8 around the source which sort of leave it sitting there all 9 by itself.
l 10 COMMISSIONER McGAFFIGAN: I know we have to get on '
11
~
to other things but my suggestion is the pilot you've 12 discussed.really wouldn't inform me very much in a l i
13 rulemaking, I don't think. !
t i
14 DR. COOL: One brief comment. You're correct. '
. 15 .The test, as proposed right now in its interactive thinking, ;
16 would not be a good test in terms of the difficulty of 17 finding older cases. That's very true. The test would, 1 18 think, be a reasonable test of the actual registration and j 19 operation of such a system, a computerized system that mails 20 out the. returns and that interaction set with licensees 21 which needs to be ironed out before you would expand it.
- 22 So for part of it I believe it would work.
23 Certainly for the part of trying to capture all the old 24 sources, no, it was not intended to go try and capture all
' 25' .the old sources at one pass, at least within the resources ANN RILEY & ASSOCIATES, LTD.
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67 1 that we had available to us in the present budgeting cycle.
2 CHAIRMAN JACKSON: Thank you. The Commission i 3 would like to thank the members of the Working Group and the 4 NRC staff for an informative briefing on the Working Group's 5 report and the staff's response to that. :
6 The Working Group presents a number of l l
7 recommendations that would improve control, they believe, i
8 over and licensee accountability for regulated devices and I 9 commend the Working Group for your structured approach to l
10 designating which devices require increased regulatory ,
l 11 oversight. I also compliment you for seeking wide l 12 stakeholder input and participation.
13 The Commission further would like to thank all of 14 the individuals, regulators, organizations and all 15 stakeholders who, in fact, participated in the Working )
16 Group's meetings, including the Organization of Agreement ,
l 17 States, the Conference of Radiation Control Program j 18 Directors, affected industries and the public.
19 The Commission does value your input in helping to 20 develop solutions. And your views, in fact, as you can see, 21 influence our thinking and decisions and strengthen our 22 actions to resolve what's been a longstanding issue.
23 So the issue, then, before the Commission seems to 24 be whether a significant amount and how much of agency 25 resources must or should be redirected to resolving the ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 Washington, D.C. 20005 (202) 842-0034 l
I i
68 1 problem of device control and accountability. The staff 2 recognizes this dilemma and seem to be suggesting a moderate '
3 approach. Included in that is a potential action plan.
4 So the Commission wishes to consider more 5 specifically the staff's recommendation relative to the 6 Working Group's recommendations, specifically this putative 7 action plan, to weigh the resource implications and to make 8 a decision accordingly.
9 So we will ask you to accelerate the development 10 of the action plan with elements include.d of the plan, i 11 schedule relative to the elements and resource implications. !
l 12 You'll hear from us on what that accelerated date is going l
13 to be.
l .
I 14 Do my fellow commissioners have anything they 15 would like to add?
16 [No response.)
17 CHAIRMAN JACKSON: If not, we're adjourned.
18 [Whereupon, at 3:37 p.m., the briefing was 19 concluded.]
20 21 22 23 l l
24 I I
25 l l
l l
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1250 I Street, N.W., Suite 300 l Washington, D.C. 20005 (202) 842-0034
CERTIFICATE This is to certify that the attached description of a meeting of the U.S. Nuclear Regulatory Commission entitled:
TITLE OF MEETING: BRIEFING ON CONTROL AND ACCOUNTABILITY OF LICENSED DEVICES - PUBLIC MEETING PLACE OF MEETING: Rockville, Maryland DATE OF MEETING: Wednesday, November 13, 1996 was held as herein appears, is a true and accurate record of the meeting, and that this is the original transcript thereof i taken stenographically by me, thereafter reduced to i
typewriting by me or under the direction of the court !
reporting company Transcriber: uda.ocs LClacu.A Susan Harris f
.j t
[
t t
DISCUSSION POINTS Rita Aldrich Principal Radiophysicist Radiological Health Unit New York State Department of Labor November 13,1996
Premises: -
+
- 1) " General Licensing" of scaled sources / devices is a basically flawed concept that tries to
' i establish a middle ground between !
exemption and specific licensing.
It fails because it results in too .
little control of hazardous sources, and invites over-regulation of !
sources that do not pose a realistic hazard if lost or stolen.
i 1
i
- 2) As long as we continue to combine source.s with such disparate comparative hazards in one regulatory class, .we will not solve the current problems. Any increase in regulatory oversight will simply shift the imbalance a bit -- continuing under-regulation of the hazardous sources and increasing over-regulation of the others. ,
i
i i
Solution: :
- 1) Divide current " generally licensed" sources / devices into those that should be specifically licensed and those that should be i exempted.
i
11/23/81 MEMO TO NMSS FROM OSP At the most recent All Agreement States meeting, the States made the following comment:
"The NRC should reevaluate the G.L.
l device distribution licensing concept and seriously consider rescinding the
! G.L. concept of licensing gauges."
4
l . . :
1 l
k The States also reported they have seen a number of incidents involving misuse of G.L. devices. I believe it ,
would be beneficial to include this
! matter as a discussion item of the next IOWG meeting.
5
If the regulatory agency has a problern with a class of specific licensees, it can address the problem with a license amendment. The ;
license is a vehicle for control: it i t must be issued before sources can be acquired; it must be amended if the person responsible for radiation safety (radiation safety officer or RSO) changes; it must be periodically ,
renewed; ;
4 I
b
1 I
proper control over and disposal of sources are the subject of periodic inspection; and proper disposal of all
- sources must be proved before the license can eventually be terminated.
i The philosophy behind regulation t of GL's is entirely different: sources .
can be acquired with no prior.
approval by a regulatory agency, by any person or company that can afford them. t 7
l Therefore, there is no prior ;
designation of a radiation safety officer, no licensing document that
- can be used to enhance control, no periodic inspections and almost complete reliance on source vendors for records of receipt and disposal.
8
<w f, r ~ - 9 - e w -e e- - -w . n e - _ _ __-
BASIC INEQUITIES -..
4
- a. SL's are subject to all code requirements (whether they make sense for a simple gauge licensee or not), while GL's are exempt t from everything except the few '
requirements in their segregated part of the regulations, plus disposal requirements.
9
SL FIXED-GAUGE LICENSEES Our experience shows that these licensees perform as well as any other SL (scaled source or loose material),
as long as the same degree of regulatory oversight is exercised.
n
. 10
Primarily, however, we need to reexamine how our resources, and our licensees' resources are being spent to regulate section 31.5 GL devices, versus similar (or identical)
. devices that are specific-licensed. Our conclusion in New York is that we are underregulating the GL's and overregulating the SL's. Our experience demonstrates that this has resulted in very good control of SL's, but that this control results from a few basic concepts:
11
l I
- 1. requiring a licensee commitment to oversight of sources and proper eventual !
disposal, before sources are allowed to be acquired, r
- 2. requiring licensees to maintain good records of receipt and disposal of sources, and of current source inventory; i i
12 j
_ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _. _ _ . _ _ _ _ _ _ _ _ _ _ . _ . _ _ _ _ . - _ . - _ - _ _ _ _ _ - _ . _ _ _ _ _ - - -_amm_ s-
- w --= _--w _- - - ._ w ._ m __ -_- __ = m-+ --_ _ _ _ __.___* * ' -- _ _ _ - - _ . -
- 3. requiring prompt notification
- to this Department of loss of control of a source; i
- 4. regularly scheduled inspections to reinforce these requirements; and
- 5. regular license renewals to reinforce licensee conlmitments.
~
13
1 We have begun a regulatory initiative to create equity between the regulation of GL's and SL's. This will improve control over GL's, while conserving both our resources and our licensees'. It will also assist licensees that have acquired sources under both SL and GL, in establishing one integrated program for equal oversight of all of their .
sources. ,
L 14 l i
E This involves creating a subset of GL's that will require a specific ,
icense to possess in the future. We would differ from the working group
- in recommending that one simple activity limit be used to define this ,
subset (1 millicurie). It also involves relieving SL gauge licensees from the same code sections that GL's are currently exempt from.
i 15
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i Improving Control Over, and Licensees' Accountability For, Specific- and General-Licensed Devices November 13,1996 Staff's Preliminary Views Donald Cool, NMSS Staff's Preliminary Views 1
Preliminary Conclusions on Risks
- Under ordinary conditions, general- and specific-licensed devices do not represent a high risk to health and safety of users or members of the public.
- Under conditions associated with loss of control, the majority of devices used under a general license do not represent a risk to health and safety of users or members of the public even
- The current general and specific licensing programs do not account for radiation exposure or property damage as a result of loss of control of licensed material.
Staff's Preliminary Views 2
I Options
- 1. Maintain status quo.
- 2. Continue with previous plans.
- 3. Develop and implement an action plan to .
address the Working Group's recommendations .
and the other issues identified by NRC staff.
I Staff's Preliminary Views 3
i Plan Components l
- Move forward with previous rulemakings, deal ,
with related issues, and work with the Agreement States.
- Pilot test registration approach. j.
- Reexamine device review criteria in 10 CFR 32.51. t
- Address licensing, enforcement, and implementation concerns.
l l
Address disposal of orphaned devices.
Staff's Preliminary Views 4 _ _
l Improving Control Over, and Licensees' Accountability For, !
Specific- and General-Licensed Devices November 13,1996 i
Joint NRC-Agreement State Working Group Report and Recommendations John Lubinski, NMSS Robert Free, Texas Working Group 1
Licensing A Specific License is issued to named persons upon applications submitted to NRC. Review and pre-approval by NRC staff.
A General License is effective without the filing l
of an application with the Commission or the issuance of a licensing document to particular persons. All requirements are in the regulations. ;
l A General License was first issued in 1959 to ,
l save Agency resources.
l Approximately 42,000 NRC general licensees possessing 460,000 devices under 10 CFR 31.5.
Working Group 2 ,
i Types of Devices Used Under the 10 CFR 31.5 General License Approximately 460,000 Devices Exit Signs 72 % 7 330,000 '
7 s
'\
\
i Other 6%
- 28,000
. -oz . .. N.' Chromatographs
- 2%
10,000
\ Static Eliminators 10%
Fixed and Portable G s 10%
44,000 l
Working Group 3
i General-Licensed Users Must i . acquire devices from an authorized distributor
. maintain labeling
. operate devices in accordance with instructions periodically test for leakage and operation have service performed by a specific licensee suspend operation if the device is damaged
. not abandon the device
. transfer the device to a specific licensee
. may transfer to another general licensee if it remains at the same location of use
. report transfers, damage, theft, or loss to NRC
. keep records Working Group 4 .
Distributors of General-Licensed Devices Must i Develop and maintain designs to meet specific safety criteria Provide instructions, precautions, and licensing information to general licensees i
- Report to regulatory authorities transfers of devices to general licensees information is maintained in the General License Database (GLDB). The GLDB is updated with information from both distributors and users Working Group 5
~ ~ ~ ~ ' ' -
Current Regulatory Oversight
. Specific-Licensed Distributors:
Evaluate device designs Distribution requirements verified through licensing Inspect for compliance
. Application and annual fees General-Licensed Users:
Maintain general licensee information Are not subject to routine inspections .
General licensees are inspected to resolve issues such as allegations, incidents, or indications of unsafe practices
. No fees Working Group 6 .
.,_- - ~-
i Status of Actions '
1 General License Registration Program .
Proposed rulemaking published December 27,1991.
Applied to ALL 10 CFR 31.5 general licensees and distributors.
Annual mail contact between NRC and general licensees.
. Final rule put on hold 1993.
I .
Staff notified the Commission on December 29, 1993. !,
Resource decision based on risk. ,
Continues to be on hold because of low risk; efforts have continued in the area of baghouse dust disposal and other initiatives.
.i Working Group 7
Is There a Problem?
U.S. Steel manufacturers (relatively small mills) have smelted radioactive sources (20 over 13 years). The costs to industry has been approximately $8 million per smelting. Costs are based on industry reports and include decontamination, material disposal, and down-time. j Through monitoring programs, recyclers have i discovered sources in scrap metal.
Licensees have reported loss of devices and losses have been discovered as a result of inspections.
. 1990 Survey 3000 general licensees surveyed.
- 6% did not respond to the contractor.
Initially, many users could not account for their gauges.
<1% of the devices were never located.
t Working Group 8 , ,
Stakeholder involvement !
Held public meetings and a public workshop I
. Participants included Agreement State personnel, Licensed Users and Vendors, non-Licensed Recipients (Metal Recyclers and Manufacturers), and other Government Agencies (DOE, EPA). j
. Agreement States:
Experienced Agreement State Personnel as Members of the Working Group
- Two Surveys j
. Organization of Agreement States' Technical Workshop Conference of Radiation Control Program Directors l
Working Group 9
Issues & Concerns NRC and AS Compatibility Cost and Fee Considerations Radiation Exposure Savings 4
- Device Design Changes That Affect All Devices Versus Only Newly Acquired l . Device Disposal t
Device Identification Devices Requiring increased Oversight General-Licensed versus Specific-Licensed Devices '
Identification of Current Users and Devices Imposing Restrictions on Portable Devices and Storage of Devices i
Working Group 10 . ,
The Problem and Components of the Solution Problem: Solution: ,
i Regulatory
- Increase contact between users Oversight and regulators
. Identify early warning signs l
Working Group 11
The Problem and Components of the Solution (cont.?
1 Problem: Solution:
Control Over & .
Require devices to have labels Accountability or tags that contain certain For Devices information and maintam durability j Require users to perform inventories (six month)
, . Require users to maintain i current inventory records Require users to assign Responsible Individual and backup Working Group 12 - .
1 The Problem and Components of the Solution t
(cont.)
1 Problem: Solution:
i
! i improper Require users to demonstrate Disposal of evidence of proper disposal or Devices face significant penalty (include '
an initial grace period for i enforcement)
- Require vendors to provide disposal information prior to initial transfer of the device.
i Working Group 13
The Problem and Components of the Solution (cont.)
Problem: Solution:
a
" Orphaned .
Define responsibilities for DOE Devices" and EPA acceptance of orphaned devices. ,
Ensure that all orphaned devices are disposed of properly.
Recommend training to non-licensed stakeholders Require devices to have permanent labeling that indicates that the device contains radioactive material.
Working Group 14 ,
Recommendations NRC and Agreement States increase regulatory oversight for users of certain devices NRC and Agreement States impose penalties on persons losing devices l
NRC and Agreement States ensure proper l disposal of orphaned devices
. NRC encourage States to implement similar oversight programs for users of NARM
. NRC encourage non-licensed stakeholders to take appropriate actions, such as instituting programs for material identification l
l i l Working Group 15
Costs & Benefits for increased Oversight Costs:
Initial Setup $3,385,000 Annual Operating:
i NRC and Agreement States - $738,000 Licensees - $4,305,000 Annual Benefits: i Steel Manufacturers - could approach
$12,320,000 L Exposure Savings - $14,000-$2,106,000 I
Working Group 16 i
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. , , - . . . - . - - ~ - . _ - , - . . - . - . _
__ . - . . . . ,.