ML20248E834
| ML20248E834 | |
| Person / Time | |
|---|---|
| Issue date: | 09/21/1989 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 8910060047 | |
| Download: ML20248E834 (94) | |
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BRIEFING ON S'TUDY OF AkhEQU ~
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DISCLAIMER L
This is an unofficial-transcript of a meeting of the United States Nuclear Regulatory Commission held on September 21, 1989, 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, l
I except as the Commission may E.uthorize.
l Q
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE 15 LAND AVENUE, N.W.
i WASHINGTON, D.C. 20005 (202) 232-6600 (202) 234-4433
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. UNITED STATES OF AMERICA I NUCLEAR REGULATORY COMMISSION L
BRIEFING ON STUDY OF ADEQUACY OF REGULATORY OVERSIGHT OF MATERIALS UNDER A GENERAL LICENSE PUBLIC MEETING Nuclear Regulatory Commission One White Flint North Rockville, Maryland
( Thursday, September 21, 1989 The Commission met in open session, pursuant to notice, at 10:00 a.m., Kenneth M. Carr, Chairman, .i presiding.
COMMISSIONERS PRESENT:
KENNETH M. CARR, Chairman of the Commission THOMAS M. ROBERTS, Commissioner KENNETH C. ROGERS, Commissioner JAMES R. CURTISS, Commissioner NEAL R. GROSS -
1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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JWJ - STAFF SEATED.AT THE COMMISSION TABLE:
SAMUEL _J. CHILK, Secretary WILLIAM C.'PARLER, General Counsel -
JAMES TAYLOR, Acting Executive' Director for-Operations
-ROBERT BERNERO,' Director, NMSS JOHN AUSTIN- NMSS STEVE BAGGETT, NMSS b
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NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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L h 1- P-R-0-C-E-E-D-I-N-G-S 2 10:00 a.m.
3L CHAIRMAN' CARR: Good morning, ladies and 4 gentlemen.
L 5 .The purpose of'today's meeting is to brief r
6 the Commission on the staff's assessment of regulatory 7 oversight of nuclear materials under a- general 8 license. During the last several years, the 9 Commission has made several initiatives to improve 10 regulatory oversight of nuclear materials. The 11 Commission is particularly interested in' assessing the 12 adequacy of regulatory oversight for nuclear materials-
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13 under general licenses.
. (? - issue wcs raised by 'NRC's Material 14 This 15 Safety Regulatory Review Study Group in 1986. The 16 Commission looks forward to hearing the staff's 17 recommendation on this issue and, if necessary, taking 18 actions to improve our regulatory program for 19 materials under general license.
20 copies of the presentation slides should be 21 available at the entrance to the meeting room.
22 Do my fellow Commissioners have any opening 23 remarks?
24 If not, Mr. Taylor, please proceed.
25 MR. TAYLOR: Good morning, Mr. Chairman.
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NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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. .L J 1 With me at-the table'from the Office of NMSS are the j i
'2 Director, Bob Bernero, and to my left John Austin and ]
l 3 Steve Baggett. All will- participate in the !
presentation.
5 To introduce this subject, I'd like to cover S just a few quick points. As the Commission known, the 7 general license program covers devices containing 1
8 radioactive- material which present relatively--
9 potentially relatively low hazards. They're used 10 widely throughout the country for important personnel 11 safety and industrial process control functions as 12 examples. They're gauges that control liquid levels, 13 weight and thickness, are examples of industrial
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14 applications, and you'll hear more about that today.
15 It has evolved within the Agency's 16 predecessor and within this Agency over a period of 17 the last 30 years and there has -- this is one of the 18 first comprehensive reviews, certainly since this 19 Agency started, that has been conducted.
20 There have not been major health and safety 21 problems associated with this program. However, the 22 Commission is aware that problems have arisen from ll 23 time to time which has raised the question of how we l
I 24 should improve and update this program. An example, 25 of course, the 3M static eliminators and that problem e.
.k 1 NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 l
(202) 234-4433
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1 which the Commission I'm sure remembers. i 2 Also, recommendations were provided by the 3 Material: Safety Regulation Review Study Group that we 4 make a general review of our policies and activities 5 on general licenses. We've also had that E 6 recommendation from several agreement states.
7 So, today, the staff will brief you with an-o 8 overview where we are in the program review and the 9 lead presenter in John Austin.
10 MR. AUSTIN: Mr. Chairman, Commissioners, 11 we'll be using 12 briefing charts for today's meeting.
12 (Slide) If I could have the first briefing 13 chart, please.
.h 14 The first briefing chart outlines what we 15 will be covering today. We'll give a general overview 16 of- the general license program itself. We'll be
- 17. identifying some of the problems that we perceive with 18 the program. We'll discuss some of the questions that 19 have been raised regarding the program and then we'll 20 describe the plans for improving nac updating the 21 overall general license program. r'i s. u .. l y , we'll be 22 discussing some of the staff initiatives and the 23 resource associated with those staff initiatives.
24 (Slide) If I could have the second briefing 25 chart.
C NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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6 1- I'd like.to first describe where the general 2 . license program fits within the overall- regulatory 3 framework. We have essentially three different 4- licensing regimen. The first is the specific license.
5 Here, we require applicants-to come to the Agency.and 6 request authorization to possess quantities of 7 byproduct material, to describe the activities that 8 they're going to carry out with that material and ,
9 require these applicants to have an understanding of 10 basic radiation protection principles.
l 11 Upon assuring that the applicant meets all 12 applicable regulations, we issue a sheet of paper to
_ _ , 13 that applicant in the form of a license that 1
! h 14 identifies what activities they're allowed to carry 15 out and what materials they're allowed to possess.
16 These licensees are under active NRC control 17 in the sense that we periodically inspect them. We 18 issue the license for a finite period of time, five 19 years. They must come back to um and seek renewal of 20 that license after that period of time, Thus, the l 21 specific license program is an active regulatory 1
22 control.
l 23 (Slide) The next regime is the general 1
24 license program. Here, a possessor of a generally 25 licensed device does not have to contact NRC prior to b
l NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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1 receiving it. They do not have to have training in 2 radiation protection principles because - the devices 3- that are authorized to be distributed to general 4 liceneees' . have safety built into them that is at a 5 sufficient level that the user can use them safely 6 without understanding radiation protection principles.
l 7 The . general licensees are under what we'd 8 call passive control. -We know who they are, but we 9 rarely contact them and they rarely contact us.
10 Typically it's more of a reactive regulatory program.
11 And the lowest level of regulatory control 12 comes under what we call the exempt practices. Here, 13 there is no control over the device. once it is
'bi 14 distributed to individuals. An example of that is the 15 smoke detectors containing americ.ium. Those are 16 exempted from the regulations after we have authorized 17 a manufacturer to construct and distribute them.
18 There's essentially no concern over the handling or 19 the disposal of the exempt devices.
20 This regime was the subject of a Commission 21 meeting last July, below regulatory concern or exempt 22 practices. The focus of the effort that we're 23 discussing today is in the middle regime. In 24 particular, the SECY paper that recently came to you, 25 SECY-89-289, deals with Part 31.5, general licensees.
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NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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1 That part covers the vast majority of generally 2 licensed devices and . encompasses those devices which .)
3 have a potential for causing a radiation hazard.
4 (Slide) If I can go to the third briefing h
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5 chart.
6 There are many provisions throughout the 7 regulations that create general licenses. There are 8 general . licenses for importing, for exporting, for i
9 ownership, but not necessarily for use. The general 10 license concept originated as an administrative 11 convenience, that is in anticipation of a large number 12 of these being designed with safety built in and a 13 large demand for them. Back in the very late '50s, I I. early '60s, the AEC decided that rather than process a 14 I 15 piece of paper for each and every gauge that was to go 16 into commerce, because of the safety being built into 17 the device, it would be much more convenient to create 18 what's called the general license. We don't l
19 relinquish total control over that and I'll be getting 20 into some of the provisions or constraints placed on l1 21 general licensees.
22 But 10 CFR 31.5 creates general licenses for 23 certain measuring, gauging, eliminating and control 24 devices. These devices are generally those of most 25 significant concern in terms of the potential for harm {
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NEAL R. GROSS l
j 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433 1
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~2 '10 CFR 32.51 ' provides for manufacturers to- ]
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'3 distribute to generally licensed. devices via a 4 specific license. Here, an organization would apply 5 for a specific license to the Agency to distribute a 6 device to general licensees. We review the design of l 7 that device to ensure that 'it meets the applicable-8 regulations and then issue what we call a G license, l
9 which is a license to that manufacturer which 10 authorizes the distribution to generally licensed 11 individuals.
I 12 We require those manufacturers to report to 13 us, or to an agreement state if that is the licensing 14 entity, all transfers that they make to general 15 licensees. -That's how we know who possesses generally 16 licensed devices.
17 CHAIRMAN CARR: or who did possess them, i
18 MR. AUSTIN: Who did, but there are 19 constraints on what the general licensee can'do after I 20 they receive it. There are prohibitions on disposal 21 and they can only transfer that device to another 22 specific licensee. But admittedly, we may not be )
23 aware of that transfer.
24 CHAIRMAN CARR: Who serves him with those 25 prohibitions and the notice?
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NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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' d ._ 1 MR. AUSTIN: When we review the-2 manufacturer's application, we require the 3 manufacturer to inform through a package insert the 4 general licensee that'they are in possession of. Atomic 5 Energy Act material and whatever other provisions that' 6 place constraints on the general licensee, such as 7 constraints on retransfer, on the -- the manufacturer I 8 must inform the general licensee that if there is an 1'
9 incident with the device or a loss of the device, that 10 they must report to the Nuclear Regulatory Commission 11 that.
12 CRAIRMAN CARH: That's just a package insert 13 in the --
["",i 14 MR. AUSTIN: Yes.
15 CHAIRMAN CARR: -- whatever he bought?
16 MR. AUSTIN: It is a package insert that --
17 CHAIRMAN CARR: Like my chain saw package 18 insert that says this is a dangerous piece of gear?
.19 MR. AUSTIN: Right. And that package insert 20 may only be read by the purchasing agent.
21 CHAIRMAN CARR: If at all. 1 22 MR. AUSTIN: If --
23 COMMISSIONER ROBERTS: Or maybe the 1 24 receiving clerk.
25 COMMISSIONER ROGERS: Yes.
NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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u 11 1 MR. BERNERO: John, if I could add. I recall 2 that when we were discussing the 3M affair, we had the 3 handout, the package insert and shared it with the 4 Commission. When you look at it you can say, "Yes, l- 5 indeed, the key information and requirements are all 6 there," but that's exactly the point. Is there any 7 assurance that the receiver reads it, understands it, l
8 and the right person understands it? We also found in 9 the 3M thing that there were people who were so 10 disorganized that they were leasing these devices and 11 putting them in the warehouse and a year later sending 1
12 those back and leasing another set and not using them.
13 One company in particular discussed that with me.
/
4" 14 So, that's one of the control aspects that 15 we're concerned about, is the lack of institutional 1
16 memory at the general licensee. Do they know they 17 have it? Do they know what it is?
18 CHAIRMAN CARH: Okay.
17 MR. AUSTIN: It's also part of the program 20 we think needs strengthening, which we'll be 21 discussing later.
22 (Slide) On briefing chart number 4, in 23 continuing the description of our general license 24 program, NRC has licensed about 54 manufacturers to 25 distribute devices to generally licensed individuals.
C NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 1 (202) 234-4433 -
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- .? '18' 1- Agreement states have ~ licensed . about176 manuf acturers m
p l2 to ~ dis tribute devices ' t o' .g e n e r ally licensed
.3 - individuals. NRC has;a; total of.about 30,000Lgeneral-14 licensees that possess about' 400,000 devices.
COMMISSIONER CURTISS: Does -that oinclude P
6- . agreement state licensees?
7 MR. AUSTIN: Does not.
8 COMMISSIONER CURTISS: Do:you-have any idea L
E 9 - how many the agreement states have issued, how many 10 devices there are out.there?
i 11 MR. AUSTIN: I think we generally have 12 multiplied.by a factor of two. Is that about --
13 MR. BAGGETT: That's the rule of thumb.
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14 MR. AUSTIN: Rule of thumb.
15 COMMISSIONER CURTISS: Sixty thousand 16 general licenses, 800,000 devices?
17 MR. BERNERO: Very rough estimate.
18 MR. BAGGETT: You have to recognize some of 19 the agreement states do not honor a general license.
20 They will issue a specific license, particularly for 21 some gauging devices.
22 COMMISSIONER CURTISS: Do Ee have a way of 23 simply asking the agreement states how many licenses
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24 they've issued of a general nature and tracking that?
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25 MR. PARLER: There certainly is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVENUE, N W.
WASHINGTON, D.C. 20006 (202) 232 6 (202)N
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'f authority to have a;way.- .
[ 2. COMMISSIONER'CURTISSi Have we asked.it?.-
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[1 3 MRI BAGGETT.: It would be. labor; intensive-- ,
4: COMMISSIONERiCURTISS: Okay.
5 MR. BAGGETT:- ~ - -
and .have to review ' the -
16: quarterly reportsione.by one.
7 ~ CHAIRMAN CARR: They might - be '. They-also 8 might have the number at their fingertip.
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9 MR. BAGGETT: They-may have. In past -- a9 10 numb'er.of years ago we'went out and looked at-some of-11 the devices and had some of the agreement. states also.
L . 12' look .at ' the.' products in the- field. They were having 13 similar. problems with the record keeping that NRC was.
l-l 14 It's such a large volume, it's labor intensive to go
- 15. 'through and weed out which licensees are maintained.
16 The quarterly reports may be one 'page or
- 17 they could be 500 pages.
18 COMMISSIONER CURTISS: We're roughly' talking-19 about 90,000 general licenses and about 1.2 million 20 devices, using the rule?
'21 MR. AUSTIN: Approximately. Enclosure 1 to 1
22 SECY-89-289 tabulates the various types of generally /
I 23 licensed devices and it also provides a rough estimate 24 of the numbers of each type of device. For background 25 purposes, enclosure 1 also contains a brief NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVENUE, N.W. i WASHINGTON, D.C. 20006 (202) 232 4 00 (202) N I
_ _ _ _____________ _____ _ _____________ _._____ ____________________________________ _ ______ _ ____j
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.1 . description of how these devices are used.
2- Right ' now,- Steve Baggett has brought in a i
3 .~ spectrum of devices,that are generally licensed and we 4 thought it would be useful for you all'to see some'of'
-5' them.
6 So,-Steve, if you could --
J' 7 MR..BAGGETT: Thank you.
8' (Slide) Could' I. have the first 35 9 millimeter slide, .please?'
10 .The general license under 31. 5 -- and - thes e
- 11. - samples do not contain radioactive material'. 31.5.'has 12 -a gamut of devices of different sizes.and models.
13' This is a static ' eliminator air nozzle 14 that's used to basically get dust' off of film- and
- , 15 plastics and used'to keep.' static charge from building
.16 up. It contains: polonium 210, around. 20 to 200
'17 millicuries of polonium 210 and it's similar to the 18 device that 3M was selling.
19 There's another device that's .used quite a 20 bit. It's called an electron capture detector cell.
21 It's used in gas chromatography and it's increasingly 22 used in the last few years because of an increase in 23 the EPA's interest in pesticide monitoring in watering 24 and air quality releases.
25 This goes into a product called a gas NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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15 IJ 1 chromatograph. We regulate this -- and this is just 2 an example of the type of labeling that's required on 3 the product. There are certain labeling conditions 4 and criteria. It contales about 12 millicuries of 5 nickel or 100 millicuries of tritium.
6 (Slide) We have exit signs. The next 35 7 millimeter slide, please.
8 Exit signs contain about 20 curies of ,
9 tritium gas. These little glass tubes are filled with 10 five curies apiece. They have a phosphor and they 11 emit a green glow. They're used for emergency exit 12 markers in residential buildings, schools, hospitals, 13 you name it.
( 14 We also have, which is -- a large part of 15 the devices are what we call gauging devices.
16 (Slide) Next 35 millimeter slide, please.
17 These gauging devices typically measure the 18 thickness of paper, density of materials. It gives J 19 you en idea of the range in construction of relatively 20 small to very robust design.
21 (Slide) Could I have the next slide, 22 please?
23 I want to give you an idea of the typical 24 conditions, environmental conditions, that these 25 devices are designed and constructed to operate in.
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NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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l-L 16 b.J l .This.is the -- gauging devices have a mechanism =so you 2 can .tell' what the concentration is of the density of 3 material. This is that monitor for a particular piece 4 of equipment to show you how dirty the environment is.
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i 5 (Slide) Next slide, please.
l-l' 6 This shows you the location of the gauge.
7 If you look right in the middle of-the screen, you'll 8 see a kind'of a whitish dot.
9 (Slide) Next slide, please.
10 Here's what the gauging device looks 'like.
11 This is a coal slurry plant in West Virginia and the 12 gauge is about two yearc old. So, it's very important 13 that they follow their general license requirement of E 14 maintaining labels, which this company is trying to do 15 by putting an additional label on the device. It just 16 shows you that we've had good operational history with
-17 these things in this type of environment, although the 18 paint -- they're not very pretty or attractive after a 19 number of years. They tend to function and function 20 well for a long period of time.
21 That's all I have.
22 MR. AUSTIN: Thank you, Steve.
23 (Slide) If I could have briefing chart 24 number 5.
25 To conclude the general description of the NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
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. 1 program, as I mentioned previously, there are a few 2 . constraints placed on the general' licensee. Part 20 3 requires the general licensee to report a theft or a 4 loss of a device to the NRC. The general licensee, as 5 we just discussed, learns of this requirement on them 6 only through the package insert,'and that can be lost.
7 or not read. We receive very few reports from general 8 licensees involving problems with these devices, but 9 we suspect that there may be more problems occurring 10 than what we hear.
11 And finally, the general licensee may only 12 transfer the device back to a specific licensee.
13 Other than those two provisions, the general
("_ . 14 licensees are exempted from Part 20, our radiation 15 protection principles.
16 (Slide) On briefing chart 6, I'd like to 17 get into some of the problems that we've experienced 18 with general licenses. The largest problem that we 19 perceive is the loss of control of the devices.
20 General licensees are often unaware of the potential 21 hazards. They do not always follow the regulations on 22 transfer, maintenance, disposal and record keeping.
23 Warning labels become illegible, making them 24 vulnerable to loss or entering into unauthorized 25 disposal channels.
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NEAL R. GROSS i 1323 Rhode Island Avenue, N.W.
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- J- 1 The .second problem ~ is the ' quality of the 2 devices. In the 1960s, when this program was just 3 getting underway, when a device was approved for 4 general distribution, the regulations were changed to 5 specify a quality assurance program that the vendor 6 had to use to ensure the safety of the device. That 7 practice of. placing into the regulations quality 8 assurance requirements for generally licensed devices 9 appears to have stopped in the late '60s. And 10 further, some of the rules that have changed since 11 then allowing devices to be generally licensed may not 12- have always been consistent with things we had done in 13 the past.
14 And finally, these generally licensed 15 devices are not required to have third party testing.
16 We think that some of the problems that we've 17 experienced in the past, had the device been subjected 1
18 to a third party test, we would have seen some of the 19 vulnerabilities early on.
20 CHAIRMAN CARR: Did I understand you to say 1
21 we don't require a QA program now?
22 MR. AUSTIN: The regulations require that l
l 23 the applicant describe in sufficient detail its L 24 quality control program. There are some ANSI l
25 standards, I believe it's ANSI standards, that in some NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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ix 19 q ;p h I cases address quality assurance, .but it is not ' what u 2 'I'd call 'a robust, explicit part of the regulatory 3- regime for these devices.
4 ' CHAIRMAN CARR: But you implied it used t o'-
5 be 6 MR. AUSTIN: Yes. The regulations still 7 contain frequency charts that certain devices had to 8 be subjected to --
9' CHAIRMAN CARR: So, the regulations are 10 there, we're just not enforcing them. Is that what 11 you're telling me?
12 MR. AUSTIN: The regulations are there for 13 some devices.- but not for others. Some of the devices
{' 14 have explicit quality assurance requirements attached 15 to them. Other devices have been added to the general 16 license provision, but they were not accompanied with 17 a quality assurance provision in the rules.
18 MR. TAYLOR: That's a mix.
19 CHAIRMAN CARR: But the regulations don't 20 address each individual device, I wouldn't think.
21 MR. AUSTIN: Initially they did, yes.
22 CHAIRMAN CARR: The license would address 23 the device.
24 MH. BERNERO: Unfortunately they do. We 25 don't have a generic rulemaking in place or a gene ric 0
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!: 20 g-I-FJ 2 1 rule in place that sets down performance standards or 2 criteria for overall QA programs of all devices. What 3 has happened -- you're licensing by. regulation really
-4 in these devices and what happens is some of them are
- l. .5 specifically required to have things, others are not.
l~
6 CHAIRMAN CARR: But in their license, not in 7 the regulations.
8 MR. BERNERO: Some of it's in the 9 regulations too. But there's a real need there for 10 consistent, overall requirements. That's one of the 11 initiatives that's clearly needed.
12 CHAIRMAN CARR: Well, could you write it
__ 13 into the license instead of the regulation?
I]"
14 MR. BERNERO: Oh, you could consistently do 15 it in every license, but I think it would be better 16 and we've discussed it in the paper to have a 17 performance oriented QA rule and then let the license 18 implement that.
19 MR. AUSTIN: I think in the past, General 20 Counsel has cautioned against generic license 21 conditions that are applied one by one without going 22 to rulemaking. My recollection is that that created a 23 problem in the past. If you're going to do the same 24 license condition over and over and over again in a 25 license, is that not --
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I i 21 I
b: 1. CHAIRMAN CARR: Well, certainly that's
'2 preferable, but I can't understand. how we started 3 regulating them correctly and'then quit, if what you 4 tell me is accurate.
5 MR. AUSTIN: Again, this appears to have 6 changed.in the late '60s, early '70s.
7 CHAIRMAN CARR: Well, when you say it 8 appears to have changed, that doesn't necessarily mean 9 to me a change. Whether it changed or we quit. I 10 don't know what we're doing. But you see my problem.
11 MR. AUSTIN: I see your problem.
12 MR. PARLER: Whatever the change was, 1 13 think I should say it was not because of legal
- k. '"
14 reasons. Perhaps what Mr. Austin said was a view that 15 was expressed some years ago. It's probably grounded 16 on common sense. If you have conditions that you 17 repeatedly put in individual licenses, perhaps --
18 CHA1HMAN CARR: I've heard Commissioner 19 Rogers express that opinion.
20 MR. PARLER: Sir?
21 CHAIRMAN CARR: I've heard Commissioner 22 Rogers express some of those in the other way, "If we 23 keep waiving this thing, why don't we waive it for 24 everybody?"
25 MR. PARLER: I think what may be kind of
(
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3 22 gE l'
. LJ . 1 confused' here is that- there is still in the 2 re'gu l a ti on s , in the requirements for t'he specific 3 license, for the manufacturer, at least broad areas 4 .that have to be addressed. The practice, as I 5 .. understand it, that was discontinued in.the late '60s 6 was for the rule that established a general license 7 for the device itself, that rule used to be 8 accompanied by a great deal of QA type detail. For 9 whatever reason that I don't know about, other than 10 the fact that people go to different jobs, leave, that 11 practice was changed.
12 CHAIRMAN CARR: Okay. Let me say it's part 13 of the third party test. Why do I want a third -- why 14 don't I just require them to provide me the 15 documentation that they've tested it correctly and 16 give me the data?
17 MR. AUSTIN: There is always an advantage of -
18 having a disinterested third party doing the test. It 19 provides an additional level of protection, rather 20 than have the proponent, the one that benefits from 21 having positive data -- rather than have them generate i 22 that data --
23 MR. BERNERO: That's a widely done practice.
24 You know, the Underwriter's Laboratory and things like ;
25 that, for devices that are in commercial distribution l
bl NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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and that h' ave a safety issue associated with them.
2 That's what the real attractionfof third party testing
, 3 is. It's' independent.
4 CHAIRMAN CARR: But it doesn't seem to me 5 'that we require that of our. reactor licensees. We 6 require them to be honest with us and do the tests we 7 want them to do and provide us the documentation.
8 MR. BERNERO: Yes. Of courne --
9 COMMISSIONER ROBERTS: There is third party 10 inspection too. You can't manufacture a reactor 11 pressure vessel without having a national board 12 inspector inspect it.
l 13 MR. AUSTIN: Some of their electrical h"" 14 l devices have been subjected to UL testing.
15 MR. BERNERO: Yes. That's a major 16 consideration in that initiative of is there a 17 commensurate reliability or quality that . comes with 18 that. These devices seem to fit the pattern that is 19 widely used in the rest of our commerce for third 20 party testing.
21 CHAIRMAN CARR: It seems so simple. Why 22 haven't we required it before?
23 MR. BERNERO: Good question. I think this l 24 whole system, in the QA, in the third party testing, 1
25 in the reporting, in so many of the things, we're
{
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24 W l dealing with a system of regulation that sort of grew 2 over the last 30 years or so. I t. ' s not surprising if 3 we look back to see inconsistencies or gaps. You 4 know, we're a lot smarter today than we were then.
5 MR. AUSTIN: It started out as a very modest 6 program back in the 1960s. There were about 4,000 or 7 5,000 devices that were generally licensed. We've 8 gone up over a factor of 100 --
9 CHAIRMAN CARR: All right. Let's proceed.
10 MR. AUSTIN: The third problem that we 11 perceive with the general license program has to do 12 with the greater than Class C waste issue. Currently,
_ _ . , 13 when the staff authorizes distribution of devices to
("\ 14 generally licensed individuals, the ultimate 15 disposition of that licensed material is not 16 addressed. It could be, and it is in some cases, that 17 the cost of disposal of that device can be several 18 times the purchase price of the device. And it's not 19 clear that the buyer is aware --
20 CHAIRMAN CARR: So, do you want to put a 21 warning label in the brochure they're not reading in 22 the package?
23 MR. AUSTIN: We have a program to -- we hope 24 will make them read it and if we put dollar signs in 25 there saying, "A bill is coming due later," maybe that j 1
I i
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H 25 I will- further encourage .them to read .the package 2 insert.-
3 MR. TAYLOR: It may cost you more to get rid 4 of it than to buy it.
5 MR. BERNERO: I'm not sure of the outcome, 6 but we have. an overall objective to have what we 7 r.onetimes en11 internally " truth in material l
i 8 licensing," so that if someone is buying or leasing a 9 nuclear device of this sort, they know the full gamut 10 of the. costs'and the obligations and they know it up 11 front and perhaps are billed up front. One of the 12 alternatives --
this is not a commitment, but it's an 13 alternative to be considered --
is the vendor, the
(~ ' 14 distributor or manufacturer of the generally licensed 15 device, if it's greater than Class C, may only lease 16 it, for example, and then he or it, the company, L 17 retains the obligation for disposal and it's up to 1
18 that company to charge an appropriate fee built into 19 the price for the greater than Class C disposal.
l 20 Or, depending on how the DOE program comes 21 out. there might be some fee that can go with the 22 device so that it is entitled to DOE disposal at the 23 end of its useful life. Those are alternatives.
24 CHAIRMAN CARR: I guess --
25 MR. BERNFRO: We want to get that cost up C
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26 b 1 front.
2 CHAIRMAN CARR: -- the vendor could require 3 sufficient deposit that it makes the guy want to turn 4 it in when he's through with it.
5 MR. BERNERO: Yes, the equivalent of a bond 6 or something.like that, yes. Any one of these things 7 might be the solution, but right now we don't have the 8 solution and these people are buying a device, a 9 greater than Class C so tree, that literally cannot be 10 disposed of and, frankly, there are only a few places 11 you can turn the things in now and it costs an 12 enormous sum to do so.
_, 13 COMMISSIONER ROBERTS: Well, would you 14 hazard a guess? Of the approximate 1.2 million 15 devices how many of them are involved in greater than 16 Class C waste?
17 MR. BERNERO: Well, I think we've got a 18 tabulation in the attachment that gives a cut at that.
19 In enclosure 1.
20 COMMISSIONER ROBERTS: One is the listing.
21 M 52. BERNERO: Yes. If you'll look at Table 22 1.1, page 5 of enclosure 1. We've got hundreds, 23 getting into the low thousands of these devices.
24 COMMISSIONER ROGERS: I une a number in my i
25 notes of 22,000.
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1 ' M R '. BERNERO: Yes. If you a dd ' -- I'm
?
2 'looking at ' the' middle - devices , fuel, densitometer, 3 gauging devices. The gauging devices. dominate, 16,000 4 of them. Many of those are. moisture density gauges,
'S-
~
you know, the. things for pavement, that are marginally
'6- greater than Class C.- They may even constitute - a -
i.
7 different class when we come down to it. There may be 8- a different thing you can do with them.
9 H R .. 'PARLER: Of course, Mr. Chairman, if 10 th e -- r eall y , the greater -than Class C are a 11 relatively small number. There is the option of not' 12 generally licensing those, but specifically licensing 13 those that have the specific license spell out all of 1 41 the pertinent details.
15 CHAIRMAN CARR: Yes. My understanding was 16' that there's somewhere in the neighborhood of 6,000 or 17 so that might fit that category.
18 MR. BERNERO: Our estimate in the table is .j 19 of the order of 1,000 or more a year are sold and the 20 number out there in service, because utny of them have 21 this long half life -- that's why they're greater than 22 Class C -- is of the order of 20,000. So, it's quite 23 a few.
24 But an awful lot of them, I would remind G. 25 you, are these moisture density gauges or pavement NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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l , 28-l' gauges that. are' used in building contracts, paving.,.
2- Iroad' building, things like that.
l 3 . COMMISSIONER ROGERS: But there 'd '.still be I
a4 the' disposal problem', wouldn't there?
5 MR. BERNERO: Oh, ,yes. They are greater
o i:
6 than Class C, but they are americium 241, which has a
- 7. .very long half life and there may be a mechanism of' 8 recycle that lends itself with them. There may be.
1 9 Some sources, they're not recyclable.
10 COMMISSIONER ROGERS: But as far as the
- 11. ' disposal problem is concerned, they're the same as.
I 12 the --
13 MR. BERNERO: Oh, you still have. to deal 14 with it because they are greater than Class C.
- 15 COMMISSIONER ROGERS: Okay.
16 MR. BERNERO: There's enough of the long 17 half life material there.
18 MR. AUSTIN: And the fourth problem we have 19 with the program is the relatively low regulatory 20 priority that it has been given. Budgetary 21' constraints have limited NRC oversight and in the 22 reviews of this paper by agreement states and the 23 regions, that was one of the most frequent criticisms.
24 CHAIRMAM CARR: We don't normally consider
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29
( l problem and that's why it got a low regulatory
'2 priority, I presume.
3 MR. AUSTIN: It is not a high public health 4 and safety problem based on sketchy information and 5 part of these initiatives are to enhance our 6 understanding of what is actually happening out there, 7 to provide better data on backing up ' the statement 8 that there is essentially no public health and. safety 9 problem there.
10- (Slide) On the seventh briefing chart, some 11 of the questions that we've been asking and talking 12' about are the following:
13 Is the general license approach viable? We
(" 14 occasionally get a comment that it ought to be done 15 away with, that there should be only two regimes.
16 Either you don't have concern over the material and 17 you exempt it, or you issue a specific license. In
~
18 fact, we could specifically license all of these 19 generally licensed devices, but that has associated 20 with it substantial resources that we think are not 21 justified given the additional controls that might 22 come under the devices."
l 23 We could inspect the general licennees, but 24 then again we don't perceive a sufficient problem to 25 treat them the same way as we do specific licensees.
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30 1 T h e' second question is, are the l 2 responsibilities of.~the various parties clear and ;
3 complied with? As we've discussed previously, the 4 package inserts may be forgotten or lost. We know 5- very little . about the 400,000 devices and whether any 6 of the required leak break tests are, in fact, being 7 performed.
-8 Are the devices that are generally licensed 9 acceptable ' for that program? Many suggest placing an 10- upper limit on 'the source content that ought to be 11 allowed in a generally licensed device.' We talk here 12 about maybe prohibiting . devices having. greater than 13 Class C waste from being in the general license
' h, .
14 program, bring them into the specific license arena
- 15. and put all the constraints we need to on it. That is 16 an option and we'll be addressing that in one of 17 our --
18 CHAIRMAN CARR: But that ignores . whether 19 it's a threat to public health and safety or not if 20 you just arbitrarily draw --
21 MR. BERNERO: Well, there, it's really 22 linking the greater than Class C category as requiring 23 a greater degree of administrative control, therefore 24 a special license. So, indirectly, it is public 25 health and safety, but it's not the risk of the device k
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- 1. 31 1 no much as the disposal of it, l
2 MR.~ AUSTIN: The specific license could, as l l.
l 3 we talked earlier, have a condition on it, that the I
4 bond be posted that will . ensure appropriate i j
5 disposition of the material when no longer needed.
6 COMMISSIONER ROGERS: Except that the 1 l
7 specific licensees have to have a basic understanding L 8 of radiation principles you've stated. And yet the 9 devices .that we're talking about are used in 10 applications where that's not required at all. So, 11 throwing those together --
12 MR. BERNERO: It's an additional burden.
13 COMMISSIONER ROGERS: --
escalates one
(.;
14 aspect of it to deal with quite a different one, 15 namely the disposal.
16 MR. BERNERO: Yes, exactly. And that's 17 why -- if anything, I'd say we're more inclined to go 18 for a financial lever. You know, something like an up i
19 front charge or a lease deposit or something of that l 20 sort which is usually a very effective way to keep--
1 21 it's like the deposit on a bottle. It's enough to 22 return the thing and recycle it.
23 CHAIRMAN CARE: It's more like the deposit 24 on your cable television box.
25 COMMISSIONER CURTISS: It does seem to me if
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,1 s.
. 32 bI 1 you're trying to get at the disposal problem with.
2 greater than Class C, that.the idea of returning it-to 3 the manufacturer --
4 MR. BERNERO: Is more attractive.
L 5 -COMMISSIONER CURTISS: And if there's a 6 - separate or additional concern about safety during 7 operation where you draw a line between, say, sources 8 that are'one curie and over, as you talked about in 9 the paper, and license those all specifically that are 10 in excess of one curie, that combination of approaches 11 might address the greater than Class C disposal 12 problem where there isn't any concern during or less 13 concern during use of the material.
14 MR. BERNERO: Yes.
15 COMMISSIONER ROGERS: We're just talking 16 sort of freely here, but as a general matter I would 17 hope that we could keep our categorization basis very 18 cl esan and.always start with the health and safety and 19 we don't get the disposal and other things mixed up in 20 that. They may be important practical problems, but 21 how we view the situation should be based, it seems to 22 me, always entirely on the safety issucc. And the 23 hierarchy we establish should be kept as pure as 24 possible on that basis and not six in other 25 considerations and screw it all up.
[
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4 9 33 1 MR. BERNERO: That's a good piece of comment 2 for us to'have. As John said early in the briefing, 3 we are graded in the degree of regulatory control 4 according to the' health and safety hazard. You know, 5 the inherent safety or the inherent risk of the device 6~ and.its use. That would be a significant confusion if 7 we start putting the waste disposal tag on things.
8 CHAIRMAN CARR: As I see the problem, it's 9 trying to. decide i f we --
10 COMMISSIONER ROGERS: Now, there is a health 11 issue there.
12 CHAIRMAN CARR: If there's a health and 13 safety issue out there we don't know about.
gh 14 COMMISSIONER CURTISS: It does seem that 15 there's a health issue in both areas where there's a 16 health concern thet we ought to pay attention to on 17 greater than Class C disposal and there's also an 18 operational concern that may be driven by a 19 distinction other than greater than Class C or less, 20 such as one curie more or less, that would govern what 21 we do during operation. But in either event, it does 22 seem to me we've got a health and safety concern.
23 MR. BERNERO: Yes, but they're so 24 different --
25 COMMISSIONER CURTISS: That's right.
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34 l
. 1 MR. BERNERO: -- and the agents who need to 2 deal with the health and safety concern are so 3 different because it's n'ot the paving . contractor who l:
4 can deal with the greater than Class C waste disposal.
'* 5 It's unnecessary to train him in repository design or 6 anything like that.
7 MR. AUSTIN: (Slide) This really leads into 8 the eighth briefing chart.
? 9 As we've seen here at the table today, there 10 are very many . useful ideas on what one can do to 11 improve the' general ' license program. With that 12 thought in mind, we prepared a draft of this paper and w 13 sent it to the regions in all the agreement states and 14 asked for those people with the hard field experience 15 with these devices, what do you think, where should it 16 go, where can we get our best bang for the dollar.
17 We received a total of 24 responses back to 18 the draft. There was strong support for doing more in 19 the general license program. The most frequent 20 comment was to be more restrictive on the types of 21 devices that could be covered by a general license and 22 there was an occasional comment to just abolish the 23 general license program and go to a two licensing 24 regime, specific or exempt.
25 COMMISSIONER ROGERS: Could you give us some b
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35 m j 1 . idea of where these responses were coming from?
2 You've got 24, so that's.not such a big number. Where 3 were they coming from?
l 1;
4 MR. AUSTIN: They were' coming from like the l , 5 state of Texas Board of Padiation Control, Florida l
l- 6 Radiation Protection Group. So, it was, in essence, 7 our counterparts in the agreement. states.
l COMMISSIONER ROGERS: What about industry 8
9 groups .in any way? Did you get anything from them?
10 MR. AUSTIN: We did not circulate it to the 11 industry groups, although I think all that go out into 12 -the field and interact with one licensee will have 13 their ear turned about their competitors and how bad
.h 14 their competitors are. But at this point, there is no-15 impact on the licensees. Rather, many of these 16 recommendations would involve rulemakings, at which 17 time they would have an opportunity to address any 18 concerns they have.
19 CHAIRMAN CARR: That last coament, I assume, 20 was from the states? !
i 21 MR. AUSTIN: Abolishing, yes. That was, I l
l 22 believe, the state of Florida. ' "
23 MR. BERNERO: I don't want to embarrass John 24 Austin, because he's on a rotational assignment to 25 Region IV, but I think Region IV suggested that we
(
)
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. b__ 'l further consider t.ermination of the general license 1
- 2 program.
l
- 3.
- CHAIRMAN CARR: Did they make that comment 4 while he was on a rotational assignment?
L 5 MR. 'BERNERO: No. He has to go down and l-6 . live with it now..
7 MR. AUSTIN: They may change that comment in
'8 the next two weeks.
9 (Slide) On chart number 9, we're now 10 getting into nome of our plans for improving and 11 updating the program. We are initiating a rulemaking 12 to require the general licensee to respond to a 13 periodic questionnaire regarding the inventory, 14 maintenance, and disposal activities. SECY-89-289 15 recommends expanding the questionnaire to include 16 obtaining information on leak tests. You do perform 17 leak tests? What is the frequency? The view is that 18- any question related to compliance with the 19 . regulations or obligations of the general licensee ,
i 20 ought to be reinforced on a periodic basis.
21 We think that this questionnaire will 22 heighten the awareness of the general licensee that
, J
, 23 they possess a radioactive source, particularly if it 24 is a responsible individual that has to respond. And 25 rather than allow the package insert now to go willy-NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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-[a 1 nilly_ within an organization, the recommendation is j
\
'l 2 .that a responsible individual within the organization' j i
3 must read the package insert and must respond on about 4- an annual basis to a questionnaire as 'to their 5 compliance with their obligations. .So we think thatl .
1 6 would help con t rol . -- have better control over the ] l
.7 devices in the field.
8 The second thing that we're doing.is.that we 9 are computerizing these quarterly transfer reports, 10 rather than have a file sitting there full of sheets 11 of papers with names and numbers on it. We're 12 entering these into the computer, in part to gain 13 better control -- a better understanding of what is
( 14 out there, and in part to assist in this annual 15 questionnaire.
16 COMMISSIONER ROBERTS: But at this point, 17 you have no idea if you have knowledge of all the 18 transfers? Is that not correct?
19 MR. AUSTIN: There is a requirement that the 20 manufacturer notify us if they transfer to a general 21' licensee.
22 CHAIRMAN CARR: But that's the initial 23 transfer.
24 COMMISSIONER ROBERTS: That's the initial.
25 What about the general licensee who then may make'some h
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4 l YI 38 h: I 1 disposition?
2 MR. AUSTIN: There is no requirement 3 associated with that.
4 Is that correct, Steve?
5 CHAIRMAN CARR: Except that he turn it back 6 to a specific licensee, the way I read your brief.
7 MR. AUSTIN: But I don't think they have to 8 report.that to the NRC.
9 MR. BAGGETT: In Part 31.5, which is the 10 requirements on the general licensee, there is a 11 requirement that the user notify the regulatory body 12 that he has transferred the device, whether to a 13 specific licensee or to another general licensee.
14 There's some very specific conditions.
15 CHAIRMAN CARR: Can he transfer it to 16 another general licensee?
17 MR. BAGGETT: There's one condition that, 18 say if a gauge is mounted in a factory or an exit sign 19 in a building, a general licensee of that gauge can 20 transfer the entire. product to a person buying out the El building, for example, and then notify NRC in this 22 case that he has made the transfer to this gentleman 23 or this company.
24 CHAIRMAN CARR: But the guy that read the 25 package insert normally doesn't sell the building.
C.
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39 C
- ; 1 COMMISSIONER ROBERTS: Yes. -
2 MR. BAGGETT: That's true.
3 MR. BERNERO: Very tenuous.
4 COMMISSIONER CURTISS: Row much confidence 5' do you' think we have, if there are X number of 6' transfers between general licensees. Do we think we-7 know about 10. percent of them or 90 percent of them?
8 What's your degree of confidence?'
9 COMMISSIONER ROBERTS: One percent.
10 CHAIRMAN CARR: Well, let's ask how many 11 reports have you gotten in the last six months?
12 MR. BAGGETT: We've received somewhere in 13 the neighborhood of 20 to 40, somewhere in that zone.
h' 14 CHAIRMAN CARR: Of a 1.2 million or 400,000?
15 MR. BAGGETT: Prior to contacting the 16 general licensees in '82 and '83 and '84, we received 17 maybe 10 or 12 a year. That's increased just due to 18 the degree of regulatory awareness. They are now 19 assigning some responsibility -- some are on this 20 annual reporting.
21 COMMISSIONER CURTISS: Sounds like it's ten 22 percent or less.
23 MR. BERNERO: I don't think we could do a 24 successful material balance, based on our --
25 COMMISSIONER ROBERTS: I think not.
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40 1 CRAIRMAN CARR: Well, I'm concerned about--
2 I don't know if these things are sold through the 3 mail. I'm sure they're not just necessarily an over-4 the-counter purchase. But I'm concerned that the 5 specific licensee, when he makes the transfer to 6 tonebody and he tells us who that was, he also tells 7 us, I assume, the name of the " responsible 8 individual." Right? That's the way I read it.
9 MR. AUSTIN: Well, it could be a purchasing 10 agent. We - would recommend specifying it be a 11 responsible individual.
12 COMMISSIONER ROBERTS: By name or by title?
13 MR. AUSTIN: At least by title.
14 CHAIRMAN CARR: But I don't have a warm 15 feeling that unless we require the guy immediately on 16 receipt to acknowledge to us that he has received it 17 and understands his responsibilities -- it's kind of 18 like for a while the FCC required you to report when 19 you bought yourself a CB radio and it got too much to 20 handle. But at least you were required to report that-21 you had one and you had a frequency.
22 MR. BERNERO: And that's a very good 23 example, because that at least told the purchaser that 1
24 there was a regulatory authority and they had an i 25 identify and there was some attempt at control.
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5; 1 .I think we're starting to draft the control 2 rulemaking here, but these are the very issues that 3 we're trying to study so that'we can see whether by 4 the. initial sales representative giving the 5 information to the purchaser, and then perhaps a 6 separate but coincident purchaser initial report to 7 the NRC, followed by . an annual reminder report that 8 requires a certait. m unt of different or. interpretive 9 thinking. In other words, not simply, "Yes, I bought 10 a device from the XYZ Company," but "I bought a device 11 and I know it's radioactive and I know this and this l 12 and that and that."
13 Our objective is to put into the corporate h' - 14 memory, "Yes, you have a device. There are certain 15 obligations that go with it, and we're going to keep 16 track of it. We'll be in touch with you on an annual 1
17 basis and we need to know about changes or transfers 18 of control.
19 CHAIRMAN CARR: And, as I say, even in their 20 brochures and their catalogues, if these things are 21 listed in a catalogue --
22 MR. BERNERO: They are.
23 CHAIRMAN CARR: -- there'd be a little note 24 there warning this requires some kind of a -- this
- 25 contains radioactive material and requires
{.
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~1- notification when you own it.
4 2 COMMISSIONER CURTISS: . Just ' looking at the l' 3. numbers here',.with 400,000 of these people licensed by '
4 the.NRC, we may get more letters than we got on the 5 emergency planning rulemaking as a. result of a process
-6' that looks at'the general licensee.
7 I wonder if there's not some 1 merit to,,
8- because of those numbers,-looking to the specific 9 licensee, of which we have what, 80, 70?
10 CHAIRMAN CARR: 130 total.
11 COMMISSIONER CURTISS: 130 total, about --
12 CHAIRMAN CARR: States and us.
. 13 MR. BERNEP.O : A much more manageable set --
14 COMMISSIONER CURTISS: --
into the specific 15 licensee and telling them, "We're interested in having 16 you track where the devices go," as they go from 17 general licensee to general licensee and then auditing 18 the specific licensee on a regular basis to ensure 19 that they've set up a mechanism to do that. It almost 20 boggles my mind that we've got 400,000 people out 21 there, 400,000 licenses here and I take it 800,000 22 that we'd like to have a similar process for at the 23 agreement state level, it may be a matter of 24 compatibility for them, where we're going to seek to h 25 track 1.2 million devices and every transfer of those.
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43 1 MR. BERNERO: Yes.
2 COMMISSIONER CURTISS: Is that a burden we 3 ought to take on or that-the~ specific licensee ought
- 4. to take on'given the interest that it has economically 5 in selling those?
6 MR. BERNERO: It's only perhaps one order'of 7 magnitude smaller, but the number of licensees is 8 going to be on the order'of -- an. order of magnitude 9 less than the number of devices, so that our 10 communications would be on average with somebody who's 11 got perhaps ten devices.
- 12. But still, it's an intimidating or daunting 13 number of communications.- But again, we're going into
(".". 14 a rulemaking draft. But if we go to the manufacturer 15 or distributor, it puts us one step removed and once 16 again we're -- but there's a real resource advantage.
17 When we went through 3M, I used to shu dd e r 18 at all of the mailings. The cost of the mailing, I 19 forget the sum, but it was in the thousands of 20 dollars, many thousands of dollars, just to send a 21 copy of one of those orders to the general licensees.
22 We did that all through 3M. It was very costly.
i 23 CHAIRMAN CARR: You're convincing me that we 1
24 ought to track what's important for public hisalth and
. 25 safety and we ought to forget the rest of it.
{. .
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I MR. BERNERO: But this is the cost 2 . effectiveness of how we track it.
3 CHAIRMAN CARR: Well. but we don't have to i
4 . track all 400,000 of those.
1 l .5 COMMISSIONER CURTISS: If the ones that are l
l
- j. 6 issued to the general licensee are as we've defined 7 them, inherently safe, there's nothing that you can do 8 or not as much that you can do with the device if you 9 read.the instructions. I guess I wonder, does it make 10 sense on the use problem to draw a distinction between 11 those maybe over a curie and those under a curie. It 12 looks to me , . just in rough numbers, like we've got
_, 13 about 15 percent of all the devices that exceed one
~
14 curie.
15 MR. BERNERO: Now I would ask you to pause.
16 The ones where the inherent safety is enough that you 17 don't have to track them, those we exempt, the smoke 18 detectors and wrist watches and things like that.
19 Those are exempt frca regulation. The reason --
20 CHAIRMAN CARR: If you took just the greater 21 than Class C and said, "That's a problem we can deal !
22 with," that limits to 20 plus thousand, more or less, i
23 instead of 400,000.
24 MR. BERNERO: That might be a segmentation 25 that can have some merit. But again, that's the --
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-1 COMMISSIONER CURTISS: That's the disposal 2 question that-Commissioner Rogers raised.
3 CRAIRMAN CARR: Well, no, that's also the 4 high --
5 MR. TAYLOR: The public health and safety r 6 issue usually comes up when these devices are 7 mistreated, smashed, broken.
8 CHAIRMAN CARR: It only comes up when you're l 9- worried about putting materiel in a Coca-Cola bottle.
10 MR. TAYLOR: Yes, or released, but in some
- 11 way where the material gets out of the encapsulation.
12 That's the manufacturer's object, is to contain it.
13 COMMISSIONER CURTISS: .Wt I take it you've
.g got a number of devices that are not greater than 14 15 Class C that are in excess of one curie that might 16 pose an operational concern that you'd like to track 17 to a greater degree than less than a curie.
18 MR. TAYLOR: We'd have to do those things.
19 MR. BERNERO: Yes. I don't recall that as a 20 category.
21 COMMISSIONER CURTISS: Just look at your 22 chart in the back of your enclosure 1.
23 CHAIRMAN CARR: But what I'm saying is 24 there's a limited number that fit the category you're 25 really worried about.
(
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- l. MR. AUSTIN: Right, correct. They're a 2 limited number, limited designs, limited materials and 3 limited uses. That is what would be explored in ' a 4 rulemaking that you would recommend that would better 5 define the criteria under which any device could be 6 within the general license program. Now --
'7 COMMISSIONER CURTISS: It seems to me just 8 looking at the numbers, if you took the areas that 9 you're concerned about, the greater than Class 0 10 devices are the ones that you're concerned about from 11 from the standpoint of disposal. If that's the 12 concern, it would seem to me to be a fairly simple 13 thing to say to the specific licensees, "You have to 14 ensure that you get those back and that you dispose of 15 them." And there are what, did we say 22,000?
16 CHAIRMAN CARR: Well, I'm sure that number 17 will be refined.
18 COMMISSIONER CURTISS: That cures that 19 problem and you're left with are there devices out 20 there in addition to those that you're concerned about 21 during operation. Just looking at the chart, I'm just 22 adding up the ones that have americium 241 in them and 23 it comes out to about a total of, oh, I think 180,000 24 self-luminous exit signs. Ones that are in excess of 25 one curie, it seems to me, are the ones that we ought
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47 1 to focus on tracking during the operational life and 2 that could be done, I think, most efficiently through 3 the specific licensee, through.the manufacturer. Tell 4 us where they are.
5 MR. BERNERO: We're going to have to nort 6 out the sets and sort out in a rulemaking the 7 appropriate segregation, reporting, possibly even 8 going -- I'd like to caution about -- we got into the 9 multi-curie. It's an old rule of thumb, if it's a 10 curie or more, it's something to worry about. But 11 there are some curies I worry about a lot more than 12 other curies. And so, it's a tough thing to draw a 13 line, a clear line --
^( 14 CHAIRMAN CARR: I can tell you right now, if 15 you're going to track exit signs, you're never going 16 to catch up with the problem.
17 MR. BERNERO: Yes. That's some of the 18 curies I don't worry so much about.
19 MR. AUSTIN: Also for enhancing the control 20 over these devices, as I mentioned previously, we 21 would require the manufacturer to inform the general j 22 licensee of the disposal cost because they could be so 23 great and for some of these smaller companies they may 24 not be able to afford it.
25 And the last tic on viewgraph 9 is what we NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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l 48 Ti a g &_J l have just been discussing, in what way might we limit l
-2 devices coming under the general license program.: We 3 would explore that in the rulemaking.
4 (Slide) To enhance the quality of the 5 devices, we would recommend having third party testing 6 of the devices. Not necessarily all of them, but' 7 decide which ones would be required to be subjected to i
8 third party testing in a rulemaking. Again, we think j t
9 this would be -- should be an independent test. Staff -
10 now has initiated its own independent testing of 11 certain devices, some tritium exit signs now, and we 12 will be expanding that program. But again, believe
_ _ _ 13 that the vendors should be required to have a third 14 party carry out those kinds of tests.
15 The primary benefit of that test is that we 16 would have better confirmation of the adequacy of the 17 design. Now we look at a sheet of paper, a paper 18 design, and have to reach a judgment as to its 19 adequacy.
20 The second part of enhancing the quality of 21 the designs is to have a performance oriented quality 22 assurance rule or a reg guide. It could possibly be 23 described in a regulatory guide. But the main message 24 is in some way make sure that there is an adequate 25 quality assurance progren. Now, there is a little NRC NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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1 oversight of and requirements on manufacturers' 2 quality assurance programs.
3 We've discussed several times here .the 4 greater than Class C waste. That issue exists whether
~5 it's a generally licensed device or a specifically 6 licensed device and we would propose to address that 7 when we respond to a previous staff requirements 8 memorandum to get back to you late this year.
9 CHAIRMAN CARR: What do you mean address it?
10 MR. AUSTIN: I believe you have asked for us 11 to gain more data on what is the problem with respect 12 to surplus greater than Class C waste. We are in the 13 process of that and we owe you a response back I think
' (;
14 it's in December of '89.
15 MR. BERNERO: And how we are dealing with 16 the outstanding problem of that, which includes the 17 interaction with DOE. I don't know if you've heard 18 it. I've just heard, by word of south yesterday, that 19 DOE has released their plan for greater than Class C 20 waste. I haven't seen it and I'm certainly interested 21 in seeing it. I've seen drafts of it.
22 COMMISSIONER CURTISS: The things that I've 23 read indicate that DOE is prepared to take on an 24 interim basis greater than Class C waste in 1990. If 25 that's FY'90, that's about two weeks away. And I C
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50 1 ' guess the concerns that I have that the General 2 Counsel raised in his June 30th memo about how you 3 track the material that goes into the DOE facility 4 that has to wind up in a licensed disposal facility, 5 it seems to me need to be addressed. I encourage you 6 to do that in that paper.
7 It may be worth taking a look at whether DOE 8 plans on taking this waste from our licensees two 9 weeks from now or making their facilities available, 10 if that's an FY'90 plan that they have. If that's the
-11 case, it does seem to me that it's also worthwhile to 12 tell the licensees in some way or another that greater 13 than Class C waste that goes to a DOE facility has to 14 wind up in a ' licensed disposal facility and somehow 15 putting them on notice that turning the material over 16 to DOE isn't the end of the regulatory chain for us.
17 It's not clear to me we've done that yet.
18 MR. BERNERO: No. We have been discussing 19 that with DOE and the DOE people just briefed the 20 Advisory Committee on Nuclear Waste about their plan, 21 oh, about two weeks ago or so. The plan has been in 22 existence for some time and it was awaiting Sectary 23 Watkins' review. Apparently, if the news report is 24 correct, the approval is there and I'm looking forward 25 to sitting down with DOE very soon to sort out these NEAL R. GROSS i
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. I-. 1 - very issues because-we have discussed them with them 2 intensively the whole idea of' tracking the-material, l' 3 the prices or costs to .be collected and how to 1 '.
4 separate an emergency possession from a routine 5 possession because we have these well loggers going 6 out of business and going bankrupt and things like 7 that.
8 CHAIRMAN CARR: Well, but I don't -- if when 9 you say you're going to address it in consonance with 10 this, you mean you're just going to add these numbers 11 in?
12 MR. BERNERO: No,.no. We have to establish
. 13 a mechanism whereby licensees have greater than Class 1 ;
14 C waste to dispose of and have a way to dispose of it 15 that is an orderly --
16 CHAIRMAN CARR: When you take care of that 17 problem, you've taken care of this one.
18 MR. BERNERO: No, not necessarily because I 19 would still have the concern that a general licensee, 20 even though the general licensee has a way te dispose, 21 a reasonable way to dispose of greater than Class C 22 waste, may not do so. They may throw it in the 23 landfill or something.
24 CHAIRMAN CARR: So why not address that 25 issue? You don't address that by solving the problem NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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,. 1 52 k I of where you're going to put Class C waste.
2 MR. BERNERO: No, that I address within 3 the --
4 CHAIRMAN CARR: But I'm concerned that 5' you're trying to-wrap it into t h'e other paper and I 6 don't want it wrapped in.
7 MR. BERNERO: No. Oh, no, no. No. We're 8 not going to deal with the ' licensee control 'of the 9 device to.make sure it reaches the proper destiny in 10 greater than Class C land. No. As long as.'there is a
- 11 generally licensed device that is of that category of 12' waste in the general license arena, we will deal'with 13 the issue of whether or not that can only be leased,
{~ 14 the vendor takes it back or whatever control mechanism 15 is appropriate and then the disposal mechanism is the 16 separate issues and that's --
17 COMMISSIONER CURTISS: A related question.
18 CHAIRMAN CARR: Having said all that, what 19 do you mean by this paragraph here7 l 20 MR. AUSTIN: The former. That is that the 21 matter of actually disposing of the greater than Class 22 C waste would be addressed and hopefully resolved in
- l. 23 the paper that is due to you the end of this year.
24 CHAIRMAN CARR: Okay.
25 MR. AUSTIN: The issue of control, I C
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.I believe, ought to be addressed in the rulemaking 2 dealing with criteria of devices that should be 3 allowed to come under the general license.
4 CHAIRMAN CARR: So you're going to address 5 it in two things?
6 MR. AUSTIN: Yes.
7 MR. BERNERO: Right.
B ,
MR. AUSTIN: Two parts.
l 9 CHAIRMAN CARR: Put a third bullet on that 10 one. All right.
11 MR. AUSTIN: The fourth initiative staff is 12 undertaking has to do with the quality of the l 13 licensing reviews of generally' licensed devices.
L
_ (I 14 Currently, all of the 29 agreement states are L 15 authorized to perform sealed source device reviews.
l-16 This could lead to varied interpretations, the lack of 17 uniformity. NMSS would like to, in achieving better 18 assurance of consistency and uniformity, take a harder 19 look at the sealed source and device registry sheets 20 that the agreement states submit to us. Now they come 21 in and they go into a folder. We can see an advantage 22 of taking them and looking at them for completeness, l_ 23- compliance with regulations, adequacy of review to 24 again provide better assurance that devices that are 25 being sold country-wide, foreign countries --
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- j. 54 1 1 CHAIRMAN CARR: But the applicant ~ is a 2 specific licensee.
3 MR. AUSTIN: .Of the agreement state.
4 CHAIRMAN CARR: He is a specific licensee 5 and when'he comes in to us or to them, he comes in to 6 license a specific piece of material under a general L
7 license.
8 MR. AUSTIN: He gets a specific license and 9 what's called a G license. The G license authorizes 10 him to distribute to people who do not have specific 11 licenses.
12 CHAIRMAN C AP.R: But not anything he wants 13 to, only particular things.
(;
-14 MR. AUSTIN: Only things approved.
15 CHAIRMAN CARR: And forget how the states do 16 it. How do we do it? How do we handle those guys 17 that come int What kind of tests do we do? What do 18 we require of the guy' !* r 4 7eu waytog the s i.a t eu 19 hren't compatible?
20 COMMISSIONER ROBERTS: I think you're saying I
21 they don't know.
22 CHAIRMAN CARR: But they know they require 23 the states to be compatible.
24 MR. TAYLOR: I think John's point is to look 25 at the devices that have been licensed by specific NEAL R. GROSS 1323 Rhode Island Avenue, N.W. .
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r 55 license in the agreement' states and be sure that the
'l i 2 collective knowledge is gathered together. So, if we i
3 see a device that we may have question with, that we'd-4 appropriately convey that and discuss Lit.. They may.
5 'even be doing something better.
6 CHAIRMAN. CARR: Oh, you mean for those 7 states that are using a specific instead of a general s 8 license for the same device?
9 MR. AUSTIN: Yes. The manufacture; has two 10 licenses that are specific to them. They have a 11 license that authorizes them to possess and use 12 material at their site. Then, as a separate matter, 13 we'. issue what's called a G license. It's essentially I
14 the same thing with a G added to it, which -- the only 15 effect of that is that we tell that licensee, "You are 16 authorized to distribute to people who do not have a 17 license."
18 CHAIRMAN CARR: But if he sakes more than 19 one product, does he have more then one G license?
20 MR. AUSTIN: No. That one G license can 21 cover thousands of products, but once he sells it to 22 that --
23 CHAIRMAN CARR: No, no, I don't mean 24 thousands of the same product. I mean two different 25 products.
C.
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- No. The point of the matter 2 is that orange box down on the end of the table, he j
3 has a specific license because he has to build those 4- things for his business and it's got --
5 CHAIRMAN- CARR: It's got radioactive 6 material, he manufactures something.
7 MR. BERNERO: But then he is licensed tc 8 distribute that device and the specifics of that 9 device,.which is authorized for general --
10 CHAIRMAN CARR: On a G license.
E '
11 MR.- BERNERO: Yes. And that's what we would 12 'like to be sure -- and we look at state exercises in 13 that as well as our own for technical and regulatory
(*.h 14 consistency.
15 CHAIRMAN CARR: But I assume we do that when 16 we inspect the state's program.
17 MR. BERNERO: Well, I'm not sure we do 18 .enough of it. There's room for more. We have had 19 substantial dialogue on this and I think there's room 20 for more --
21 CHAIRMAN CARH: Let's go back to my second 22 question. If the guy that makes the orange box also 23 makes the exit sign, has he got another G license?
24 MR. AUSTIN: Yes, separate.
25 MR. BERNERO: For that device. For that 1
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57 1 device, the exit sign.
2 MR. BAGGETT: He would have one piece of 3 paper and item A on his' license to sell would say this 4 orange one and item B would say this particular one 5 here and there would be --
6 CHAIRMAN CARR: So we add to his G license 7 as he comes.in for another product.
8 MR. AUSTIN: Right.
9 CHAI2iMAN CARE: Any time he sends us a 10 product.that he wants to add to his license, what' kind 11 of testing do we require?
12 MR. BAGGETT: The regulations require that 13 he submit testing to demonstrate to us that it will 14 survive the conditions of use. This one would be a 15 lot.of testing, say dropping it from 30 feet, and this 16 one may not be --
17 CHAIRMAN CARR: But that's spelled out in 18 our regulations.
19 MR. BAGGETT: It says that you will provide, 20 right.
1 21 MR. BERNERO: Excuse me. I don't think it's l
l 22 spelled out in our regulations. It's spelled out in l
23 our testing licensing review activity, our specific 24 review. I don't recall the regulations setting down 25 like a type B package or anything like that set of NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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b l 2 CHAIRMAN CARR: How does he know what to 3 submit to us when he sends us his piece or his data 4 for.his exit sign?'
l 5 '
MR. BAGGETT: We have some regulatory guides L
6 that explain what we're looking for in a product 7 design and references some of the ANSI standards . to 1
8 give them an idea of types of testing that we're 9 looking for.
10 MR. BERNERO: And he has performance 11 objectives that are in the regulations about doses 12 under normal conditions or accident conditions.
13 CHAIRMAN CARR: And I assume that's a matter h 14 of state compatibility. So, I'm trying to go back and 15 find out what it is you're going to --
what you're 16 worried about in the licensing review area. The fact 17 that we're not doing it?
18 MR. AUSTIN: That we need --
19 CHAIRMAN CARR: Or the fact that we're not 20 doing it well or the fact that we don't require enough 21 documentation?
22 MR. AUSTIN: The sealed source in device 23 reviews can become rather complicated. Sometimes 24 you're dealing with rather simple things, others get 25 rather complicated. It takes a certain critical mass h.h NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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59 1 of ' individuals to understand what all they need to 2 look into'of a design to determine _its adequacy for 3 general distribution. It's not obvious that- a l l' 4 agreeJent states have that critical mass. Maybe they 5 do, maybe they don't.
6 CHAIRMAN CARR: Do we have it?
- 7. MR. AUSTIN: We have it.
8 CHAIRMAN CARR: Do we use it?
9 MR. AUSTIN: Yes, sir.
10 CHAIRMAN CARR: Okay. So, it's a matter of 11 inspecting the state programs to make sure they.
12 comply.
13 MR. AUSTIN: Yes, and the regulations, in my
" 14 view, are not complete. There's room for 15 interpretation, how far do you go, you push harder in 16 this case but not in that. The thought here is that 17 because this involves worldwide distribution of 18 radioactive devices, should not a federal agency have 19 a firm understanding of the adequacy of the reviews?
20 See, we never turned over to the agreement states the 21 authority to issue E licenses, exempt distribution.
22 NRC, NHSS performs those reviews because of the 23 national implications of it. Here, is there not a 24 middle ground where we receive their product, their l 25 engineering evaluation, their safety evaluation 1
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- 1. report, the design and say, "Would we have approved .
-2 that? Does it meet what we think the. requirements 3 are?"
4 CHAIRMAN CARR: Well, that's.why they send 5 it to us, I assume.
6 MR. AUSTIN: They only send us the 7 registration sheet for the device such that it is in a 8 central location, so that if someone else tooks to 9 manufacture that device, they can rely on that sheet.
10 But in terms of evaluation of the adequacy of that 11 sheet and conditions, we do very little of that now.
12 ' CHAIRMAN CARR: Well, from talking to the 13 states' guys who talk to me, they lead me to believe
(? 14 they do a better job of it than I do.
15 MR. AUSTIN: In some cases, that may be 16 true. In other cases, I'm not sure it's true.
17 CHAIRMAN CARR: Okay. Let's proceed.
18 MR. BERNERO: Now, at this point, let me 19 take over.
20 (Slide) Could I have slide 11, please?
21 In one editorial version of this paper, we 22 had a table that's a little more detailed. It might 23 be a useful supplement to you here. Basically, we're 24 talking about the two budget years, FY'90 and FY'91, I
^
25 in harder terms than we talk about the out years. If C r 1
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.p' i li._J i .I we're going to do some of this activity, what are the- j i
2- resource implications?- If ' you look at this more f 3 detail'ed table that I gave you a' photocopy of, it has-L 4 two basic categories, the FTE required for- these 5 initiatives and the FTE already allocated. Obviously,.
6 FY'90 and '91 are the harder numbers and FY'92 to '94 7 is prospective or speculative. In the already 1
8 allocated number, it's that out year budgeting process 9 that we have.
10 In essence, this should give you a scale of 11 the overall activity, the number of FTEs involved in 12 all of .the categories. In FY'90, we're going into 13 this tracking maintenance and developing the reporting 14 requirements and the follow-up inspection activity and 15 the important thing to note is this is an information 16 gathering phase. We should be a whole lot smarter 17 about the situation a year from now than we are right-18 now.
19 Our prospects for how big is the problem or 20 how small is the problem can change rather 21 significantly because this early activity is the 22 information gathering where you find out are they 23 really in a disorder and scattering these things to 24 the four winds or is it just that we didn't have 25 sufficient information to see?
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62 1 So, if you look at the resources allocated, 2 we've got it broken down into the five categories of 3 regulatory activity and in a footnote of this table 4 and in the Commission paper we spoke of it. The 5 Office of Research has a one and a half FTE per year 6 underpinning for us to r,upport this rulemaking 7 activity. So that at last mentally add that to the 8 FTE figures you're looking at.
9 Now, the things I would invite your 10 attention to in looking at the resources are, one, in 11 the current years this state oversight -- it's the 12 fourth item in the table, expand oversight of 13 agreement state program and provide more technical h~ 14 assistance to states. We do not have two additional 15 FTE allocated there but we've got an agreement with 16 our colleagues in state programs that we're going to 17 try as resources are available from one source or 18 another to ease into that in the years prior to our 19 ability to actually budget for that. We consider that 20 just below the line in priority and therefore we 21 haven't actually allocated those FTE.
22 If you'll look at the column for FY'92 and 23 '94, the projections of the tracking for an expanded 24 annual survey of four FTE per year is probably a 25 realistic one. We think that will be a realintic b
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_ 1 expenditure.- But.if you look down to t h e t h i r d i t e m ,-
2 review-. vendor QA programs, increase licensing .and 3 inspection effort, we're foreseeing one - FTE to. get 4 going on that in the requirements end, and perhaps 5- four FTE if we follow a pattern such as we're talking 6 about in the medical QA where we're going to go out 7 and verify the implementation of the- device QA 8 programs. That's probably a fairly realistic number.
9 The certain devices to be specifically 10 licensed, the thing on the bottom, that's up in the 11 air. That could be -- if we came to a regulatory 12 conclusion through rulemaking that a large fraction of 13 these devices should be done by specific licensing, 14 that could be very resource intensive. On the other 15 hand, if we find that there is an orderly way to deal 16 with them in the general license arena, then that 17 number of resources would be much, much smaller.
18 So, I just want to give you --
this is 19 obviously not a budget briefing, but I want to give 20 you the flavor of the information gathering phase 21 being such that in the out years, the necessary 22 resources to pursue the proper general license program 23 remain to be established firmly. We will, of course, i 24 propose, as the information comes in, propose in our 25 future budgets.
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64 1 (Slide) May I have slide 12, please?
2 CHAIRMAN CARR: Before you leave that one, 3 you're telling me that you've got seven people 4- allocated through '94, if I add up the last column, 5 and you need somewhere between 11 and.16 more by '94-6' if I add up the last column in the required.
7 MR. BERNERO: Yes. But that's why I wanted 8 to give you the -- in the last column of the FTE 9 required, the four for item number one is probably a 10 fairly good number. The four for the item number 11 three, is probably good, but that bottom one is mushy.
12 CHAIRMAN CARR: Well, but --
13 MR. BERNERO: And it dominates.
(b 14 CHAIRMAN CARR: -- 11 to 16 is not very 15 mushy. I mean that's not very accurate, shall we say, 16- anyway. But what you're telling me is we need to 17 throw in 11 to 16 more FTE to take care of something 18 you've already said you don't think is a threat to 19 public health and safety, but you don't have the data.
20 MR. BERNERO: I'd just go back to the 21 proposal that in the current budget years we're 22 putting in the control activities that will establish 23 what we have and we could end up with the low end of 24 that scale which would be, I think, the necessary 25 discipline for a general license program to ensure the
(
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- 'l public health and safety. And the high end of that 2 resource program would be associated with discovering 3 enough problems that we have to withdraw items .from 4 the general license program and put them in the 5 specific license program which is.more costly.
6 CHAIRMAN CARR: All right. Let's go ahead.
7 MR. BERNERO: Have slide 12.
8 Let me just summarize our conclusions.
9 Recall what was in the paper and'what John's briefing 10 covered. We've come to the conclusion that we should 11 continue the general license program but give 12 increased attention to it. We don't have enough 13 information to say with adequate confidence that
{.,, l' 14 everything is in excellent condition or excellent 15 shape. There are just too many unknowns, too many 16 doubts.
17 So, we have these initiatives that we've 18 spelled out in the paper. They have already started 19 and they will proceed and as each rulesaking or l .
l 20 whatever comes to a head, we'll be coming to you with l
l 21 them. They're on the two fronts, basically and 22 initially to improve controls, to get a better handle 23 on everything that's going on, who has them, do they 24 know they have them, what happens to them, and 25 secondly, to enhance their quality. And so you'll see NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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-b 1 'the priority in our initiatives is first and foremost i
2 to the improvement of controls and-of course getting 3 the -information. for that, and then secondly enhance 4 .the quality-of the devices that are under control.-
5 So, that concludes our presentation.
6 CHAIRMAN CARR: Questions?
7 Commissioner Rogers?
8 COMMISSIONER. ROGERS: No,.I don't think so.
9- CHAIRMAN CARR: Commissioner Curtins?
10 COMMISSIONER CURTISS: Nope.
11 CHAIRMAN CARR: Well, I've got all kinds of.
12 problems with this thing. The first one is it looks 13 like 'we've been doing nothing for three years since
- {:' 14- they reported out their study that said we ought to 15 get on with it. When I get the briefing here today, I 16 kind of get the feeling that there's still not 17 something I can get my arms around and say, "We're 18 going to have that done by this time."
19 When I look at your table, I'm not sure that 20 we don't already have the data we need. Somebody can 21 set down and look at those sources and make a little 22 bit of a study of what we know about how they're put I together and decide whether there is a real threat to 2 the public health and safety. I don't think we have 3 to do a lot more than that. I
(
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<M-1 1 It wouldn't take a lot. of analysis to sit l' ;
l 2 down- and look at 'what the sourc'e is, how it's !
l 3 encapsulated, what they use it for, and make a 4 decision on which of these are really going to be a L
l 5 problem, either from disposal or from misuse or 1
'6 whatever. And after they've got that, then we can act 7 on that. If we're worried about disposal, we make 8 whatever is necessary to make sure- that it happens 9 that way. If there are some in this list that aren't 10 worth worrying about, that are BRC, then let's quit 11 worrying about those.
12 I don't understand, I guess, why it's a two 13 or three year more problem when we've had three years 14 to work on it. The recommendation's there. Everybody 15 recognizes it's clear. The states are-bitching. We 16 recognize that the problem -- and it seems to me we've 17 got a better handle on the problem than you left me 18 with the idea that we do. That may be mistaken on my 19 part, but I stand ready to be corrected.
20 But I think it seems to me that the risk to 21 the public is what we ought to base all this.on. And 22 once you decide that, since we know what we're dealing 23 with here, the way to figure that out is pretty 24 straightforward.
25 The question that we don't know is what's NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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I b, 1 out there it seems to me. And you say you're working
~2 on that and you're going to get a handle on that 3 within=the next year, and I'm glad to hear that. But-l 4 I think personally I'd like to see the staff provide .) !
5 the Commission within a reasonable amount of time---
G which seems to me three or four months'-- an analysis j 7 of the potential health and safety aspects 'of these l
l 8 devices and identify those that you think greater 9 regulatory control is required on, and give us some 10 recommendations so we can do something.
11 I get the impression here we're going to 12 launch off into r. long study of the problem and then 13 some day down the pike we'll come up with some
. {,:'
14 solution to it, maybe, if we've got enough manpower 15 and money, and.that leaves me a very warm feeling.
16 MR. BERNERO: Mr. Chairman, I think that I 17 can say this, that in a short time span-of the order 18 of three to four months we can give you an analysis of 19 the sources in that table and I can forecast the 20 degree of report that we can make. I would expect 21 that virtually none of them would fall into BRC, or 22 almost none. I doubt very much that you'll find any 23 of those sources --
24 CHAIkMAN CARR: Even if we get the BRC rule 25 out?
l C
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69 1 I 'l MR. BERNERO: Even with'the BRC policy out, 2 1 think that Just by the simple ' fact that they are 3 designed to meet accident release and normal exposure 4 standards that are in the regulations and that are 5 substantially different from what'one' associates with 6 BRC, I don't think any'of those are going to fall into 7 BRC land.
8 CRAIRMAN CARR: All right.
9 .MR. BERNERO: I think we will be able to 10 identify, though', a category -- I'll call them the 11 " worry set," or the " troublesome set," that are up at 12 a range that could --
13 CRAIRMAN CARR: Something a lot less than 14 400,000.
15 MR. BERNERO: Yes. But a small set-that are 16 in a category that might be potentially or actually 17 ineligible for general licensing, that in a better 18 world you would have requirements that succinctly 19 exclude certain devices.
20 Now in rule of thumb, we have referred to 21 those as the greater than one curie devices, but 22 that's too simple a definition. You know, it's not 23 adequate. But I think we could identify that category 24 of sources in this list that fall into the arena that 25 maybe these things shouldn't be generally licensed b
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.h 1 devices "and how can we define them .out of the L" ., 2 universe.
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3 But 'I would say I would expect that that 14 ' analysis would tell you, okay, you've reduced the list 5 n little. bit if - you just arbitrarily rule out the-6 troublemakers or worry devices.
7 CRAIRMAN CARR: Probably an . order of' 8 ' magnitude. <
9 MR. BERNERO: I doubt it. I doubt it very 10 much. -I think you'll still have a very large number 11 of pavement: gauges, moisture density devices, and coal 12 slurry devices.
13 CHAIRMAN CARR: Because only of their (b ~
14 source?
15 MR. BERNERO: That you will have --
16- CRAIRMAN CARR: I want to know what the
~17 threat to the public is.
18 MR. BERNERO: Yes. If it gets out --
19 CRAIRMAN CARR: 'If it's properly 20 encapsulated, am I worried about it?
21 MR. BERNERO: Well, as we said in the paper, 22 the threat to the public, we don't know of anyone 23 who's ever been killed by one of these sources the way 24 they've been killed by a teletherapy source or by a 25 radiography source. But they can get a significant C"
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- I 71 1 exposure if the: source is somehow drilled ~ through or
.2 broken up.
.3 CHAIRMAN CARR: But you can also take a look 4 and see how it's used and decide what the. probability 5 of that is.
6 ~MR. BERNERO: Oh, we do. In fact, the 7 regulations say what-it has to be in' order to qualify.
8 CHAIRMAN CARR: And I would assume we 9- already would have done that or we wouldn't have it in 10 the box as a generally licensed item.
11- MR. BERNERO: Yes. We establish in the 12 regulations the requirements for the normal exposure 13 and for the acciders t exposure potential for that 14 device in order to qualify for the general license.
15 CHAIRMAN CARR: And what we're worried about 16 now is have we done that right and have we made a 17 mistake in some of those.
18 MR. BERNERO: Yes.
19 CHAIRMAN CARR: And all I'm saying is, 20 you've got the data, why don't we look and decide 21 whether we've made a mistake? And those few items we 22 sight have made a mistake with, come to us and we'll 23 change it.
24 MR. BERNERO: You're talking about what 25 amounts to a rereview of --
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72 h . I' CHAIRMAN CARR: That's what you' re talking 2 about,.I think. You're saying:that we've got some out 3 there generally licensed that' we - shouldn't have 4 generally licensed.
5 MR. AUSTIN: The devices that are out there 6 comply with' 32.51 and 31.5. If we went to a --
in 7 . essence, what you're saying is should we revoke the G 8 license of one of the vendors for those.
'9 CHAIRMAN CARR: Or something.
10 MR. AUSTIN: And the licensee can say, "I am 11 in compliance with all of your regulations. On what 12 basis are you revoking my G license?"
13 Rather, you could start a rulemaking that h 14 would allow the vendors a - chance to comment on it, 15 that says, "We will use this thought process in 16 deciding whether or not a device should be generally 17 licensed or specifically licensed." And it's going to 18 be backfit. And you could go through that 19 administrative procedure.
20 MR. BERhERO: John, wait a minute. I think 21 the essence -- there are two reasons why a device on 22 that list might indeed come off that list.
23 One reason is, in retrospect when I look at 24 it I think the review that authorized its distribution 25 was flawed, that it doesn't really meet the criteria
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[_ -_. .1 ;in fthe regulations'. That's ~ one reason.. And that'is F '2 an - extensive reanalysis - of the docket and accident 3 ' calculations, models','whatever.
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H -4 There is another reason, and'that's_what I L5 was referring-to by the. troublemakers. It is the ones 6 that do meetE the nominal criteria,- but' are -close-f 7 enough to the upper end'of it or -
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8 CHAIRMAN CARR: Or that common sense says, 9' " Hey, we.shouldn't have done that."
l'0 HR. BERNERO: -- constitute a- sufficient 11 uncertainty that we would say, "In order to exclude 12 these, I'm going to have to change-the rules."' -I'm
. 13 going to have to redefine the criteria to say "Here 14 are the criteria you meet, and in addition you meet 15 'some other. criteria or set of criteria in order. to 16 include or exclude appropriate' sets."
17 So I was talking about the ones that would )
18 ' presumably meet _the criteria, but would be at .the 19 borderline. And I think what you're talking about is i 20 an audit of the review process for whatever number of 21 devices it is.
22 CHAIRMAN CARR: What I'm talking about is, 23 if we've got generally licensed items out there that 24 are ia threat to the public health and safety, either 25 from a disposal operation or improper disposal or from (J' !
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74 1' a misuse, and we know what those' are, then those are 2 the . ones we.ought to focus on. And it seems to me 3 we've got enough data to know which-those are.
'4- MR. BERNERO: We certainly know the greater 5 then. Class C, and we are focusing on those. .And'I 6 think that in this time period' we can ' sharpen the 7 focus' on the- ones that are' in either category,
-8 possibly flawed safety evaluation or within the' 9 expected safety evaluation criteria, but so close to 10 be uncomfortable.
'll CHAIRMAN CARR: Well, we can make a 12 Judgement on that.
13 MR. BERNERO: Yes, we can make that C:
- 14. judgement. I think we can do that.
15 CHAIRMAN CARR: And it's important, of'
' 16 ' course, to remember we've got-to consider the state's 17 _ perspective in all this, which you've been doing, I 18 think.
19 Any comments from my fellow Commissioners 20 additionally?
21 COMMISSIONER ROGERS: Well, just the -- that 22 additional 11 to 16 people per year looks like a 23 pretty substantial commitment for us to make, and 1 24 think we better be darn sure we know what we're doing 25 and what we're getting for it, because it's a big NEAL R. GROSS 1323 Rhode Island Avenue, N.W.
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I price tag compared to all the other things that we 2 have to do that are on our plate.
3 MR. l BERNERO: That's the very reason we're 4- '
laying it on the table,- not in budget space, but in 5' programmatic forecast.
6 MR. TAYLOR: You haven't made a budget.
7' MR. BERNERO: No, no.
8 CHAIRMAN CARR: Well, as I said, I'm glad to 9 see we're getting on with'it. It seems to me we could 10 have done -- we're late in doing our work.
- 11. COMMISSIONER ROGERS: I just think that some 12 of the points the Chairman has been making suggest
. _ , 13 .some ways that you might reanalyze this whole thing or 14 look at it in a little different perspective, because 15 I can't add anything to what he said. I haven't 16 really quite. feel I've got a grasp of this thing yet,
.17 but I have a sense that somehow we're going by the 18 numbers in some way and what we have to do is not 19 count up numbers, but really go back and reanalyze the 20 situations. And I think that's what the Chairman 21 seems to be suggesting to me, and I'd like to 22 reinforce that.
23 CHAIRMAN CARR: I think the thing it comes 24 down to is there's some of this stuff should be 25 specifically licensed or not, and that's what we're kl.
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'1l . going to - arrive at. But I'm convinced that there's 2 not reason to'do 400,000 specific licenses.
3 MR. TAYLOR:. I agree.
4 . CHAIRMAN CARR: I - would be surprised if-5 there was~ reason to do 10,000 specific licenses out of 6 those things. It ought to be'some where down -- I' 7 sean, that should bound it, in my-opinion, but'I may
'8 be wrong But-we need a good argument if we're going 9- to say more than that.
10 Any other comments? If not, we stand 11 adjourned.
12 (Whereupon, at 11:40 a.m., the above-13' -entitl'e'd matter was concluded.)
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CERTIFICATE OF TRANSCRIBER 1 This.is to certify that the attached events of a meeting of the. United States Nuclear Regulatory. Commission entitled:
TITLE OF MEETING: BRIEFING ON STUDY OF ADEQUACY OF REGULATORY OVERSIGHT OF MATERIALS UNDER A GENERAL LICENSE PLACE OF MEETING: ROCKVILLE, MARYLAND DATE OF MEETING: SEPTEMBER 21, 1989 were transcribed by me. I further certify that said transcription is accurate and complete, to the best of my ability,.and that the transcript is a true and accurate record of the foregoing events.
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i GENERAL LICENSE PROGRAM 10 CFR 31.5 CREATES GENERAL LICENSES FOR CERTAIN MEASURING, GAUGING, ILLUMINATING, AND CONTROL DEVICES c10 CFR 32.51 PROVIDES FOR MANUFACTURERS TO DISTRIBUTE GENERALLY LICENSED DEVICES VIA A SPECIFIC LICENSE MANUFACTURERS REPORT 00ARTERLY TO NRC OR TO AGREEMENT STATE ALL TRANSFERS 3
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ABOUT 54. MANUFACTURERS LICENSED BY NRC
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! TRANSMITTAL TO: I Document Control Desk, 016 Phillips gl j ADVANCED COPY TO: The Public Document Room
! DATE: /0/3/fi 3
SECY Correspondence & Records Branch i: FROM:
I.
!!' Attached are copies of a Commission meeting transcript and related meeting ll document (s). They are being forwarded for entry on the Daily Accession t.ist and l placement in the Public Document Room. No other distribution is requested or
[ required, f Meeting
Title:
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$17$ndsc Lx) 260 x2 bs _
Meeting Date: 9 / 2 / / F /'
Open X Closed
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Item Description *: Copies ll ,
Advanced DCS
- 8 to PDR Copy
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ll j:' 1. TRANSCRIPT 1 1 l li, , a 1 : ,
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- PDR is advanced one copy of each document, two of each SECY paper.
C&R Branch files the original transcript, with attachments, without SECY j!j 3
papers.
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