ML20134H070
| ML20134H070 | |
| Person / Time | |
|---|---|
| Issue date: | 08/29/1996 |
| From: | NRC |
| To: | |
| References | |
| NUDOCS 9611130513 | |
| Download: ML20134H070 (140) | |
Text
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l 1 U.S. NUCLEAR REGULATORY COMMISSION 2
RADIOGRAPHY WORKSHOP Houston, Texas
! 5 6 I AUGUST 29a 1996 l 7 i 0'
8:30 O' CLOCK A.M.
9 l
10 11
!m t, 12 PRESIDING OFFICIALS:
13 CHERYL TROTTIER ,
l 14 LARRY CAMPER 15 DON NELLIS 16 17 18 j 19 20 PREPARED BY:
JUDICIAL TRANSCRIBERS OF TEXAS, INC.
22 7035 West Tidwell Building J, Suite 109 23 Houston, Texas 77092 24 (713) 462-6434 l-j Proceedings recorded by electronic sound recording, transcript A_ 25 produced by transcription service. g
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lO MS. TROTTIER: Today, I thought this would be a good I
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- time for us to obtain some comment on a rule making that we are l
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! about to undertake. And so, what we're going to try to do today i
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is give you a little background information on where we are, what l we hope to accomplish in the coming months, and what the real 5
purpose for today is. ;
- As I said, we are beginning to engage in rule making activity, and this is going to focus primarily on the 8
requirements that are currently in 34.20, which are the equipment 9 l requirements. As most of you know, we have upgraded equipment i requirements over the years, and in fact, last January 10th of 11 l
'96, the requirement that all equipment meet those -- that all I equipment in use meet the new requirements went into place.
( )' 13 At that time, I think a lot of people were surprised at how l 14 I widespread those requirements were and in particular, the issue !
15 l of how associated equipment was involved in those requirements 1 16 was brought to the attention of a lot of people.
17 Now, what we have received -- in fact, I guess we 18 received it before that date, but we received a petition, and Don 19 Nellis from our office is going to talk about that in a little 20 bit. But anyway, we received a petition from Amersham 21 i Corporation requesting a review and a modification to 34.20, i 22 particularly regarding associated equipment.
I 23 We are currently evaluating the petition. It's 24 l
out for comment right now. The comment period on the petition itself ends the beginning of September. What that process is r
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really about is anyone who has a comment about what the 2 Petitioner is requesting is welcome to provide comments to us.
3 We use those comments, then, in resolving petitions. But we 4 thought that this was a good opportunity particularly because we 5 have received a lot of inquiries in the last year regarding the 6 role of associated equipment in the requirements of 34.20 and a 7 concern that it was not clear what we really meant. Then maybe '
8 it was time to relcok at the whole Section 34.20.
9 And so, in doing this relook, what we thought is 10 this is a good opportunity before we go too far down the road and 11 develop a proposed rule half in the dark if not totally in the 12 dark that we obtain some comment and input from those it most O directly affects, which is why we decided to hold this one day 13 1
14 workshop. We don't really have a lot of prepared material.
1 15 Larry Camper from our licensing and inspection i
16 policy office, whereas we're from the rule making office, is ]
17 going to talk about some of the activities that they have 18 undertaken in the past year so you understand the current policy 19 that the agency is following. But what we hope to do is give_you 20 an opportunity to tell us where you have concerns. We will then 21 factor all of those concerns into any further rule making that we 22 Will Proceed with.
23 The current system that the agency uses for those l 24 of you in the audience that are from Agreement States is that 25 Prior to developing a proposed rule now, we prepare what we call i
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a rule making plan. This is not going to have the detailed words i
2 that a rule has, but it gives you the idea of what the rule will '
1 k out. That goes out to the Agreement States, and so the 3
4 Agreement States will have early input into the process prior to 5 us developing a proposed rule.
6 Timingwise, I don't expect to see a proposed rule ,
7 n the street for at least close to a year just because of the 8 amount of time it takes to get the rule. making plan developed, I 9 ' approved, and then followed by developing a proposed rule, which 10 w uld have-to be approved by our Commission before we could 11 publish it. So, we're probably talking close to a year, but we 12 just thought that this would be a good time while we're very
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'v 13 early in the process to have a better understanding of where as a 14 user you see problems in our current regulations.
15 Now, I will tell you that the purpose of this is 16 not to go back on the current requirements that all equipment 17 needs to meet 34.20, in particular, the camera. You know, this 18 is not really the topic here. The main topic that we understand 19 of concern is the issue of the associated equipment. And so, 20 we're really going to focus on that. The Commission has made the 21 decision that, in fact, that the January 10 date was valid, and 22 we have not decided that we're going to change that. So, you're 23 certainly welcome to make whatever comments you want, but I'm 24 just saying our primary purpose here is to see what is our next 25 step, what is the next thing that we need to do if any changes JUDICIAL TRANSCRIBERS OF TEXAS, INC. j Fax (713) -162.3042 . Office (713) 462 6434 l 1
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C y are necessary in the equipment rule.
2 I think with that because I probably just totally 3
confused everyone, I'm going to turn this over to Larry Camper, 4
who is the chief of our -- it's so confusing -- medical and 5
academic whatever -- it's too long a word. But anyway, I'll let 6
Larry explain where they are on the program. ,
7 (Talking off the record) 8 MR. CAMPER: Good morning. Can you hear me? I look 9 around the room and I see a lot of familiar faces over the last 10 two days, and I feel like I'm in a room full of old friends here.
11 And I see some new faces. I want to welcome you. Day three of 12 what I think has been a very productive workshop.
13 As Cheryl mentioned, I am Larry Camper. I'm the i 14 chief of the medical, academic, and commercial safety branch. )
l 15 For those of you who weren't in the last couple days, I'11 tell 16 you what that means is that I'm responsible for developing 17 technical and regulatory policy, licensing, inspection guidance, 18 and so forth as it pertains to medical, academic, commercial, 19 industrial users and (indiscernible - coughing). We've got 25 20 PeoP l e in the program, three sections. It's a big shop, and we
-21 interface routinely with Cheryl's branch in research. They 22 develop the rules. We provide the technical policy input, and 23 together, hopefully, we create something that makes some sense.
24 I'11 give you my phone number again if you want.
25 It's (301) 415-7231. Feel free to give me a call if you have any O
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y followup questions about what I say today.
2 As Cheryl was saying in her opening comments, what 3 we're trying to do today is I want to take a few minutes to step i 4 through where we are today, essentially, tell you why we're 5 there, what we've done about the 34.20 equipment requirements 6 that became effective in January of this year. And then, in my 7 concluding comments, sort of set the stage for what I hope will 8 be the primary focus and discussion that Cheryl was pointing out. .
1 9 And that is, we really desire to be large sponges as we talk to you today, and there will come a point in this discussion where I )
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11 suspect you'll be doing most of the talking and we'll be doing 12 most of the listening because problems have been laid at our 13 doorstep about 34.20 associated equipment.
14 Cheryl was alluding to in her comments the idea of 15 a rule making that could be on the streets in a year. Bear in 16 mind what she's saying is not the rule making that we've talked 17 about over the last of couple of days, a major revision of Part 18 34. We're talking about a new rule making yet to pass that would 19 f cus upon associated equipment issues.
20 So, with that, let me sort of tell you where we 21 - are. We have a rule that was first -- it was published as a 22 Proposed rule in 1988. That is the current 34 -- our 34.20 1 23 requirement. It requires substantial safety improvements, ,
l 24 including the embodiment of ANSI standard N432-1980, and the rule i
25 itself was published, it's final (indiscernible - coughing), ;
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.y January 10th of 1990. So , some six years ago.
2 At that time, we made efforts to inform all ;
3 licensees and Agreement States of this regulation, and the 4 regulations required that equipment used radiographic operations l S. in-part meet certain specific requirements, that the exposure l l devices and associated equipment must comply with ANSI N432-1980, l 6
7 and that " crank-out" devices must use improved connectors, have l
8 automatic securing mechanisms, use label source assemblies, guide !
l 9 tubes meeting certain criteria, and so forth.
10 Now, bear in mind if one goes back to that point 11 in time, you really have to go back even further, this rule
, 12 making initiative came out of a 1984 radiographic equipment 13 design safety task force, a series of recommendations from tihis 14 task force. This task force consisted of federal and state 15 regulators that had been put together because of increasing I
16 concerns about high levels of exposure within the industrial j
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17 radiography industry. j 18 In fact, if you go back and look at some-of the l 19 background where it talked about some of the exposure, what you 20 would find is is that back in the 1980s, we were having 21 situationswhererabiographersrepresentedsomethingontheorder
-22 of three to five percent of licensees, but were encountering 25 23 to 35 percent of overexposures. So, in the 1980s, there was l
l 24 concern. The task' group was created. The federal state 25 regulators ultimately made recommendations. Recommendations JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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> b i V y ultimately embodied in the rule making that was published in 1990. Okay. So, that's sort of how we got at that rule making.
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3 Okay. Now, the effective date of the rule was 1991, ne year after publication, the idea being there of course 4
5 to give the industry time to absorb this change. Two years after 6 the published safety rules which were made at the'end of January 7 1992, all newly manufactured equipment -- all new newly 8 manufactured equipment was to comply with the requirements set ,
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f rth in 34.20. And this time line was used to allow time for !
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10 manufacturers to change their design processes and their-11 manufacturing processes and ensure that all new equipment after 12 1992 met these requirements, and that went off very well. The d 13 manufacturers were able to adjust by and large. They were able 14 to meet those time lines by and large. There were one or two 15 minor exceptions that were ultimately straightened out, but the 16 industry was prepared to give to radiographers equipment meeting 17 those~ standards.
l 18 Five years after the effective date, 10 January of 19 '96, or six years after publication, all equipment in use had to 20 comply with 34.20. So, first, it's the manufacturers equipment 21 1992 forward. Come January 10, 1996, this year, just a few
-22 months ago, all equipment in use had to comply. Okay..
23 Now, as it turned out, despite that time line and
{ 24 despite what I think was certainly a reasonable effort to allow 25 the industry time to adjust to this change, we ran into a number i
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O y of problems, and it resulted in us having a flurry of activity 2
during the summer and early fall of 1995. And what happened was was that several letters were transmitted to our agency by 4
congressmen representing industrial radiographers primarily in 5
the state of Louisiana, maybe Texas, but certainly Louisiana. I 6
think there were three congressmen involved. And we held a 7
meeting with several licensees. They came to Washington. We met 8
with them. I think there were about a half a dozen of them. ,
9 And basically, the concerns that they expressed to 10 us dealt with the January loth, '96 deadline, and their concerns 11 were such things as why impose a deadline 10 January versus just 12 letting the old equipment, you know, age as it will and O ultimately we will replace it. They had some concerns about the 13 14 new equipment, the automatic securing mechanism on the new 15 cameras as required by the 34.20 requirement in particular, for 16 example.
17 There had been some reports early on that some of 18 those security mechanisms had failed. So, these licensees 19 expressed a concern about that. They were very concerned about 20 the cost to replace the equipment, and finally, the analogy I 21 like to use is I can drive my old Volvo until the doors fall off, ,
22 and-it's still a safe reliable Volvo; why do you make me go. buy a 23 new Caprice or whatever. In other words, my equipment still 24 works. fine. It's safe. It has a safe operating history, and my 25 Perators are familiar with it. Why do you want to. impose and JUDICIAL TRANSCRIBER $ OF TEXAS, INC.
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i 1 require me to buy new equipment when the old one is working just i 2
fine. 1 3
S , that was essentially what their concerns were.
4 And they, in essence, asked us to either delay the implementation
- 5 date, 10 January date, spread it out over a much longer period of ;
6 time, say five or six years, or as an alternative, let it l
! 7 replace -- we can replace equipment as it ran through its normal 8
aging process. Well, we felt the need, then, of course, to go 9
get more information as we often do when we're presented with 10 such a series of important concerns.
11 And so, what we did was we surveyed equipment 12 manufacturers, we surveyed several licensees. We kept that 13 number to below nine because otherwise, we would have to go 14 through an O&B clearance, and we also polled Agreement States and ,
15 we said -- basically, in the questions we said, tell us about 16 this; these are the concerns that have been expressed to us; how 17 legitimate do you think they are; what is your perspective on 18 them; and, you know, what should we do about the 10 January date.
19 Well, basically, the manufacturers said we are 20 prepared to meet that 10 January date. We have equipment on the 21 shelves or we can produce equipment to meet those deadlines. We 22 are prepared to satisfy the rule. We have put a considerable l 23 amount of effort and money into preparing for this rule, and we l think that it should proceed. They did express some concerns 24 25 about their customers and, of course, the ability to come up with l
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1 the funds necessary to buy replacement equipment in a short time 2 line, but the manufacturers were ready.
3 We Polled the licensees and we got a mixed bag.
4 They range from yeah, we're going to be able to meet that 5 requirement to we bought some cameras; we'll have to buy some 6 more, but we can do that because we staged the use to no, we've 7 got to replace, you know, 15 or 20 cameras; we haven't done yet, 8 and we've been waiting to see if the rule is going to become a 9 reality to yeah, we've replaced all of our equipment and, by 10 g 11y, everyone should because if you don't, it's not fair. So, 11 we've got a spectrum of answers.
12 With regards to the Agreement States, we did poll k 13 22 of 29 Agreement States. The Agreement States essentially said LT7' 14 thatall(ff'th{/fourAgreementStates, those being Washington, 15 New Hampshire, Kansas, Arkansas, have adopted a rule equivalent 16 to 34.20 with an effective date of 10 January 1996. Some states 17 indicated they would not support an exemption or extension of the 18 10 January '96 date, indicating that it would te unfair to
, 19 individuals who have complied with the *tle. Some states, the 20 ones in particular were going to also put in place a similar rule 21 or were going to handle it through license traditions. So, 22 essentially, the Agreement States were in line with the rule.
23 We also got several letters as a followup to the 24 meeting that we had with the six licensees. They sent us r'}
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25 followup letters reiterating essentially what we heard during the JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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y meeting and tried to reinforce their position, which we then took into consideraticn as well.
2 All right. So, then we had to figure out what we 3
were going to do about this. So, what we did was we prepared 4
what we call a Commission paper, where the staff presents to the 5
Commission a particular issue. It could be any issue in this 6
7 Particular case. It was whether or not we're going to proceed to 8
the 10 January limitation date, and that Commission paper was SECY-95-284 if you want to make a note of that for your record.
9 If y u want to obtain a copy of it, it is available. Entitled 10 11
" Industrial Radiography Equipment Requirementh Deadline" dated 30
- 12 November 1995 13 And basically, what we did in this paper is we 14 Provided a background and a recommendation, and in discussing the 15 background, we pointed out to them that what -- you know, what l 16 had been presented to us, what our survey had revealed, what our _
i 17 Perception of what the motivating factor were, which to a large 18 degree seemed to be economically motivated, and we suggested to 19 the Commission that we would proceed -- we should proceed with 20 the 10 January implementation date, that the industry had in fact 21 been given adequate notice. There had, in fact, been adequate 22 time. Manufacturers were prepared to provide cameras. Costs had 23 been considered in the rule making, and that we thought we should 24 Proceed.
We also included in that Commission paper a copy j~} 25 v
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1 lUA 1 of an information notice that would be provided to licensees to l 1
2 make them aware and remind them of the 10 January implementation l
3 date. We also discussed a discretionary enforcement approach, 4
which I'll cover in more detail in a moment about we woul6 deal 5 with individuals who have made efforts to replace their cameras, 6 and we also contained within this Commission paper letters that ;
7 would go back to the licensees that came to us as well letters to I 8 congressmen that had expressed some concern on behalf of their 9 And as I said, the recommendation was to proceed.
constituents.
10 The Commission came back with a staff requirements ,
_ a GM i 11 memorandum. That's "RM" as we refer to them, in which they told 12 us to proceed and only made one minor adjustment to the i i
(O) 13 information notice, and that had to do with how we would be 14 handling enforcement states those licensees that had made a 15 legitimate documented effort to replace the cameras.
16 With that, then, we next proceeded to develop l l
17 Information Notice 95-58, entitled "10 CFR 34.20; Final Effective 10 Date", and it is dated December the 18th, 1995. Now, the purpose 19 of this was to make the regulated community aware of the fact 20 that the 10 January date was rapidly coming tipon them, and that 21 the bottom line was you've got to comply. In the information 22 notice, there were some -- some interesting pieces of information 23 were contained, and if you'll bear with me, I'll read a couple of 24 them because I think it's worthwhile to remind you of what we 25 said.
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The NRC reminds its industrial radiography 2
licensees that after 10 January 1996, only radiographic 3
exposure devices and associated equipment which complies 4
with the requirements specified in 10 CFR 34.20 and is 5
authorized by the license shall be used in industrial 6
radiography operations conducted in the areas of NRC 7
jurisdiction. The NRC also reminds Agreement State 8
licensees working in areas of NRC jurisdiction under 9
reciprocity that they are also subject to these 10 requirements. The regulations in 10 CFR 34.20 apply to all 11 radiography equipment. This includes portable, mobile, and 12 fixed radiography cameras (both pipe liner and " crank-out" 13 type devices), source changers, and other associated 14 equipment used with radiography cameras, i.e., source 15 assemblies, drive cables, guide tubes, control tubes, source 16 stops, etcetera. j 17 Some provision of 34.20 only apply to certain 18 types of equipment. For example, 34.20 (c) only applies to l 19
" crank-out" cameras, while 34.20 (a) and (b) apply to all 20 radiography cameras and all associate'd equipment.
21 We then went on to say that with regards to i
22 associated equipment:
23 Traditionally, certain associated equipment has 24 has not been independently registered and/or evaluated by 25 the NRC or the Agreement States. This includes drive JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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O 1 cables, guide tubes, or source stops. With the new camera 2 models introduced, the manufacturers and NRC have taken the 3 system approach as denoted in the American National Standard 4 N432-1980, entitled " Radiological Safety for the Design and 5 Construction of Apparatus for Gamma Radiography", now 6 -equired by regulations. Therefore, information concerning 7 the drive cables to be used with the devices was included as 8 part of the overall system evaluation. However, older 9 associated equipment -- which we'll be talking about in more 10 detail later -- may not have been evaluated as part of a I 11 device registration process.
i 12 Licensees are reminded that 10 CFR 34.20 makes the
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( makes the licensee responsible for ensuring that the 14 equipment meets regulatory requirements. The licensee 15 should obtain information from the equipment manufacturer 16 which shows the equipment complies with 10 CFR 34.20 17 criteria, including any required testing. Equipment that 18 has not been registered will, at a minimum, require l J
19 prototype testing -- that's if prototype testing is allowed l 20' -- to meet the requirements of 34.20. If a similar piece of 21 equipment has already met the test results, then an
.22 engineering analysis -- we'll hear that again later today, 23 it's important -- may be used in lieu of actual testing.
24 The engineering analysis can be performed by the user or the 25 manufacturer and submitted to the appropriate regulatory JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 authority for evaluation and approval.
2 We then go on to say something about exemptions.
3 Basically, what we say about exemptions is that we will consider 4 exemptions to 34.20. We will not routinely approve them. We 5 will consider them, and the basis for considering them will be 6 only for limited special or unique cases where the licensee can 7 demonstrate that the engineered safety features, use limitations, 1 l
6 and procedures would compensate for not meeting the requirements 9 and afford similar or increased radiation safety protection. An 10 example of a limited special or unique case would include a 11 nonportable device used in a fixed radiographic facility.
12 Performance of radiography after 10 January '96
,m 13 with equipment which does not comply with the requirements j 14 of 10 CFR 34.20 is a violation of Commission requirements. l 1
15 We go on to say that it would be a Severity Level 16 III violation. And for those of you who were here yesterday when l 17 I was talking about our enforcement policy, you know that at 18 Severity Level III, we are in potential for civil penalty phase, l 19 and we're in potential for a public analysis of the violation.
20 We then went on to say that:
21 However, the Commission intends to exercise its 22 enforcement discretion for licensees who make a good faith l 23 effort to comply with 34.20 before the effective date of the 24 rule. Therefore, a licensee who performs radiography after j 25 10 January '96 with equipment that does not meet 34.20 will b
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not be subject to civil penalties or suspension of 2
1 operations for such violations if the licensee has evidence l
3 that on or before 10 January '96, it in good faith ordered 4
equip :ent for prompt replacement which meets requirements of l 5
34.20.
1 6
So, that was the essence of the Information Notice 7 95-58. After that, though, we realized that there was still 8
confusion as it related to associated equipment. So, then, what 9
we did next was we published Information Notice 96-20, entitled 10
Demonstration of Associated Equipment Compliance with 10 CFR 11 34.20", and that's dated April the 4th, 1996. I know you can 12 read all this on the screen, but I say it all for the record.
(,< 13 So, just bear with me. Again, these information notices, both of 14 them are available for you if you'd like to read them.
15 Now, this particular information notice focused 16 strictly upon associated equipment, and the essence of the 17 information notice was to try to tell you how you might go about 18 satisfying the requirements of 34.20 for the associated equipment 19 through the so called nexus approach. Now, we point out that we 20 amended our regulations to permit licensees to use an alternative 21 value of torque for performance testing of certain of the 22 equipment. We have done that previously.
23 We then go on to point out that:
24 NRC and the Agreement States review and evaluate l
l,m 25 radiography-associated equipment, guide tubes, exposure
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i O 1 heads, and collimators, as well as sealed sources, 2 radiographic exposure devices, cameras and source changers 3 for compliance with 10 CFR 34 -- Part 34. Upon completion 4 og this evaluation, acceptable components are identified on 5 a registration certificate. Information is also included in 6 a National Registry System maintained by the NRC.
7 I think it's important to point that out because 8 later we talk about the petition. You'll see that one of the 9 contentions in the pecition is the question of whether or not. ,
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- 10. associated equipment is evaluated as part of the sealed source )
11 device process. So , I want to point out that we were pointing 12 out that we.do do that process, and we'll talk more about that 13 when we talk.about the petition.
14 The regulation on performance requirements for 15 radiography equipment, Section 34.20, require that the 16 radiographic exposure device and all associated equipment
! 17 must meet the requirements of ANSI N432-1980, and other 18 specific requirements listed ~in 34.20. Associated equipment 19 includes source assemblies, drive cables, guide tubes, 20 control tubes, cranks, "J" tubes, collimators, exposure 21 heads, and source stops.
22 Now, there have been some questions which were
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23 raised concerning what constitutes an exposure head versus a 24 guide tube. We went to explain that': j 25 Exposure heads may be a separate or integral part O JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 l of a guide tube. NRC's analysis of associated equipment, ,
i 2 that is, collimators, guide tubes, exposure heads, has shown 'j i
3 that there is little risk of obstruction of source travel ;
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for equipment that guides the source assembly a distance of l 5
less than ten times the length of the. source capsule.- NRC's !
6 analysis included a review of equipment designs and i 7 incidents involving several travel obstructions. Based on !
8 these findings,_NRC's policy is that associated equipment 9
that guides the source assembly at a distance greater than 10 l ten times the length of the source capsule, i.e., exposure l
1 11 heads, "J" tubes, jet engine probes, source stops, and so ;
1 12 forth is considered a guide tube and must meet the testing j 13 requirements for guide tubes. In addition, NRC's policy is l 14 that only associated equipment that comes in contact with 15 the source, for example, collimators that slip over the end 16 stop must meet the applicable testing requirements.
17 Here was the main message of the IN:
- ' 18 The NRC has identified-several ways which
! 19 licensees can demonstrate that their radiography equipment f
20 meets the 34.20 requirements. First, the most direct method l
21 would be that the equipment has been labeled by the 22 manufacturer pursuant to a registration certificate. If the ;
23 label is worn off, you should contact the manufacturer or 24 have support information as described below. Secondly, i
25 alternatively, licensees can make this demonstration if they ;
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1 can provide a document trail to register associated !
2 equipment. The document trail can be a purchase order i 3 listing the radiography equipment that can be tied back to a !
4 registration certificate, documentation from the 5
manufacturer verifying that the equipment the licensee is !
6 using was approved and registered with the NRC or an i 7 Agreement State. Documentation must clearly identify which 8
equipment meets this requirement or the third method is a i !
9 signed NRC or Agreement State recognized checklist 10 certifying that the licensee has evaluated its equipment, 11 and that it meets the specifications of the checklist. In )
12 order for the checklist to be recognized, it must have been 13 provided by the manufacturer to be recognized and approved l
l 14 by the NRC or the Agreement State.
15 At the time of the information notice, we included 16 one checklist which had been provided by Amersham.
17 If a licensee possesses and intends to use 18 radiography equipment that is not labeled by the 19 manufacturer or that the licensee cannot demonstrate that it 20 meets 10 CFR 34.20 requirements, then the licensee must 21 submit an application for a custom review. l 22 So, that's the four ways provided in the nexus l
23 approach. All right. Then, the next thing, the next big step in 24 the process was as Cheryl alluded to. We did receive a petition ;
, 25 for rule making, which was submitted by Amersham, which we l
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O 1 published in the Federal Register Notice 3837 on the 18th of 2 June, 1996. And we'll talk about that in the next slide or two, -
3 and we'll talk about it in great length when Don makes his 4 i presentation.
5 Now, with regards to the exemptions, what I have 6
seen in exemption requests since the 10 January date? I've had [
7 18 exemption. requests. Now, that number troubles me for one or 8 two reasons either I've got a lot of licensees that are in I t
9 noncompliance. We have 160 licensees, we do, NRC does . pw+<(Y ' .I !
10 . Agreement States have the remainder of a total of about 600. j
- 11. Either I've got a number of licensees out there that are still 12 using associated equipment of the days gone by and have not .
13 l sought an exemption, and the equipment doesn't meet the criteria 14 l of 34.20 or I don't have much of a-problem. It's one or the 15 other.
l 16 Now, I hope that it's not the former. I would 17 love for it to be the latter that we just don't have much of a 18 problem. And maybe one of the things you can tell me today when 19 we get into this part of the discussion is do I have a problem or 20 not because if 18 exemptions, it's not high on my scope of 21 concern. It's not the kind of thing that would compel me to 22 recommend that we pursue rule making to change the 34.20 23 associated equipment. And if on the other hand, I've got 24 licensees that are in noncompliance or I've got licensees that 25 really don't understand what the problem is or that the j JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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2 or it's not a safety significance, then that's a fodder for I-
'3 consideration for ruling. And we want to do something about this-4 problem if indeed it's a problem.
l j 5 All right. So , what did the exemptions -- what j 6 did they ask for. Well, nine dealt with fixed cobalt sources, 7 the device that's used in fixed setting themselves, one mobile 8 device which was used in the seal, four portable field devices, 9 four guide tubes. The guide tubes were the -- two of them were 10 the "J" tubes used by the airline industry, and we hurriedly gave 11 them an exemption because we~obviously didn't want them to not be 33 using their "J" tubes to test aircraft engines, and we talk about 13 a public health and safety problem. So, we quickly approved 14 those exemptions. So, they provided some compensatory safety-15 measures, not the least of which was they could only be used 16 within these aircraft engines, source and exposure mode within 17 the engine.
18 We approved ten of the requests to date. Six of i 19 those were fixed cobalt devices used in seals. One was a 20 portable fie'1d device and three guide tubes. In the case of 21 those eight that we did not approve, we could not approve them 22 under the circumstances presented under the information as 23 provided. They -- either they didn't provide adequate 24 compensating measures. They did not provide somoching that was !
25 an equivalent to margin of safety or they di.1 not provide an t
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l O 1 adequate justification or a unique use scenario. Bearing in mind 2 that the economic argument was in and of itself, not adequate nor l
3 necessarily was a safe operating history. !
! I 4 So, we still have active ongoing communication 5 between those other applicants. I have now gotten back responses l
6 from those eight exemption applicants. We are continuing to 7 review those exemption requests. In the case where we had 8 unapproved requests, we pointed out to them in the letters that 9 they had not given us conditions or criteria as set forth in
! 10 Information Notice 95-58, in that they would be limited special 11 cases, use limits, unique cases, or adequate compensatory 12 measures. But we may hopefully grant the other exemptions 13 depending upon whether or not that criteria can be met.
14 Now, the Amersham petition, I want to say just a 15 couple of things about it to set the stage for Don's talk later.
16 I promise not to steal his thunder, but to sort keep it in the 17 flow of things, we have received the Amersham petition under our l
18 regulatory Part 2.082. And the essence of the petition is that 19 we should remove the ANSI 432 application to associated equipment i
20 and make it regulatory guidance rather than rule language, 21 require inspection and maintenance of associated equipment, that 22 device registration due should not include associated equipment.
23 Other issues such as consistency or I should say 24 inconsistency amongst the regulators are addressed. The petition 25 points out that it's marked indifferences on how the Agreement
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l lO 1 States are handling this versus our handling it.
l A cost benefit 2 argument is made, and the fact that there was little or no 3 industry awareness. And again, Don will talk more.about that 4 later.
5 part 34 revision, we've talked about this a lot 6 over the last couple of days. For those of you who were here, 7 you kind of know where we are on that. I've guardedly said over 8 the last couple of days and I'll do it one more time for the 9 record that this rule is now before the commission for its l 10 consideration with protesting what we categorically refer to as
- 11 quiet space, in that we don't normally talk about.pending l
12 regulations which are before_ commission consideration. If you l
13 stop and think about it, it makes a lot of sense that when the
! 14 policy, the Commission itself, is considering a rule which its l
- 15. staff has presented to it, it's there time to analyze the rule, 16 and it's something that we truncate our discussion of it at that j 17 point in time, 18 But as I have repeatedly, if we're going to have a 3 19 meaningful information exchange, it just so happens that your 20 workshop is occurring at a time when we are where we are. And I 21 think it's important to convey the information to you to the
? l l' 22 extent that we can, albeit in guarded fashion because where we 23' are in the policy stage. But I think that's in keeping with what 1
24 the Commission would prefer. We want to be open to the extent 25 .that we can or that the administrators sit back and allows us to JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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2 Now, we did publish a proposed rule on the 28th of l
3 January of 1994. We have subsequently been working since that 4
time to address the comments that were received. As I mentioned l 5 the last couple of days, the final rule has gone to the 6
Commission on the 3rd of January [ sic], just a day before the 4th 7 of July. It's now up there for consideration. A couple of 8
interesting things to bear in mind about that particular rule 9 package.
10 The final rule has eliminated the proposed 11 labeling requirements for associated equipment. That was one of 12 the issues of cont;entions in the comments, and the staff has
, [ \
(,) 13 recommended a provision that would remove those labeling 14 requirements not at least in a small part because the licensee 15 can't -- doesn't necessarily have the capacity to be able to come 16 up with the information to label the associated equipment. Just 17 might not be able to get that information, and therefore, it 18 seems unreasonable to expect them to do something that they 19 literally may not be able to do.
20 The final rule with modified guide tube crushing 21 test criteria, it would take it away from the ANSI requirements 22 and, rather, refer it to a test that simulates conditions of use 23 because the ANSI standard may not necessarily be as applicable as 24 one would like as compared to the conditions of use.
25 I think, then, that the other thing that I would
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O l i share with you is something else that we have suggested that is l l 2 terribly important. It sets the stage for the conversation that I i
3 we'll have later. We point out that paragraph 34.20 (f) in the I 4
proposed rule would specify that all associated equipment t
5 acquired after 10 January '96 had to be labeled to identify the 6 components and so forth and so on has been deleted. I mentioned 7
that.
8 The NRC is currently reevaluating the 9 applicability of the ANSI standard N432-1980 for associated ;
10 equipment. In response to comments raised on the proposed rule l 11 and subsequent comments from a number of licensees requesting 12 interpretation information of notice 95 -- excuse me -- 96-20 t'%.
-() 13 issued 4 April 1996, the NRC will consider the need for an 14 amendment to 34.20. In the interim, NRC inspections will focus !
15 on safety issues and incidents relating to safe -- to associated -
16 equipment.
17 I found myself engaged in a discussion the other 18 evening with one of the manufacturers who absolutely implored me 19- to make it clear to you, the regulated community and 20 manufacturers that are here, that at this point in time, one of 21 the things we are trying to do is to address this is my group is 22 developing what we call a temporary instruction. A temporary 23 instruction is what we use to guide our inspectors as they go 24- about inspecting any requirement, whatever it may be. In this 25 case, it's associated equipment and 34.20 requirements as to how l
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- 2 What we are working on telling them in that 3 inspection guidance is you should be looking first and foremost >
4 to see if they're using an imaging camera that meets the t 5 requirements of 34.20. You should be looking to see if the .
6 system generally appears to be working, the components appear to 7 be compatible, and only in the case where you can obviously '
8 discern noncompatibility or what appears to be a safety ;
9 significant issue, should you pursue the question of associated !
10 equipment. We can do that as part of the inspection process.
11 That seems like a reasonable approach to do in inspection space 12 at a time when we are reassessing as an agency the direct l O 13 applicability of the ANSI standard and its application on l 14 associated equipment.
15 And while addressing some of the concerns that I 16 have been expressed by the regulated community and some concerns 17 that have been expressed by Agreement States as to how they 1
18 choose to go about inspecting and evaluating the associated l 1
19 equipment issue, I think it's important that you know that, and I 20 agree with the manufacturer that I was talking it. I think it's 21 important that you know that because it tells you how we're 22 handling it in the interim, whatever we may ultimately do.
(
23 Now, I thought I'd just very quickly run through 24 what the requirements are in 34.20 only in terms of the various 25 sections that are included in there. I'm not going to go into JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 the details of all those requirements, but just quickly for those 2
of you who in the last 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> have not pulled out your 10 CFR 3 Part 34 and reviewed 34.20 equipment requirements and those of 4
you who could not put down that Tom Clancy novel last night and 5
look at 34.20, I thought I'd just step through this real quickly.
6 34.20 (a) basically says that equipment must comply with -- yeah, 7 Don did his. He's good. Equipment must comply with ANSI N432-8 1980.
9 Now, some of you have said, well, you know, why i 10 did you put an ANSI standard in your regulation, and this 11 standard has been updated in 1981; so, why do you have 1980 in 12 here. Well, there's a couple of reasons for that. One is i m 1 l( 13 because at the time -- and again, it's terribly important that 14 one get in the time machine and travel back to what was going on 15 in the 1980s or early 1990s in the field of industrial 16 radiography. And that is, we felt -- the regulators felt based 17 to a large degree on the recommendations of the task torce that 18 it was important to have a minimum set of standards. You might 19 recall -- you can probably recall the horror stories of the 20 garden hose and those kind of things, some of the jury rigging 21 that was going on with some of the equipment back in those days.
22 So, let's have some minimum standards. Okay.
23 That's an applaudable thing to do, I think, to embrace an l 24 industry standard, to have some minimum sets of standards. But 25 of course, the downside is any time you put an ANSI standard or
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U 1 any other organization standard into your regulations that's 2 subject to be modified, you're faced with the question of should 3 it be modified when using these standards. Also, when -- on the 4 timing on new ANSI standard in '91 in terms of the rule, there 5 was a timing mismatch, didn't necessarily line up. And also, if 6 you loo'k at the ANSI standard in 1991, the criteria is even more 7
burdensome to deal with as related to associated equipment.
8 So, anyway, that's what (a) says. 34. 20 (b) 9 basically deals with labeling of Type "B" containers and 10 modifications that applies to radiographic exposure devices, 11 source changers, source assemblies, and sealed sources.
12 34.20 (c) (1) deals with source assemblies control tube o
IQ 13 connections, and basically, this is criteria that is designed to 14 prevent disconnection of these devices. 34.20 (c) (2) deals with 15 automatically securing the source, and this basically says that 16 when the source is cranked in, it needs to be automatically l 17 secured.
18 34.20 (c) (3) that there shall be safety plugs or 19 covers on all outlet fittings, lock boxes, and device cable ;
20 fittings. 34.20 (c) (4) deals with labeling, and it requires that I 21 there be a danger erected label on the license. 34.20 (c) (5) 1 22 deals with guide tube crushing kinking tests and things that are I l
23 required the ANSI standard in environments that are encountered.
24 As I mentioned a moment ago, we're moving more toward l i l
! 25 environments that are encountered.
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i 1 34.20 (c) (6) requires that you must use a guide 2 tube when moving a source out of the camera. There must be a 3 guide tube used. 34.20 (c) (7) must use exposure head. Basically, 4 this says that you must use an exposure head at the end of the i 1
5 guide tube as an excellent source from the end of the guide tube.
6 34.20 (c) (8) connector and tensile test, which basically brings to 7 bear the ANSI N432-1980 for guide tube exposure connections.
8 34.20 (c) (9) source changer, source security system. When -- and 9 this is a requirement that when you're either connecting or 10 disconnecting the guide tube source, you don't want an accidental 11 withdrawal of the source when connecting or disconnecting. '
12 34.20(d) points out that all new systems after
- 'p ,
13 1992 had to meet these requirements. 34.20 (e) , which is the one 14 that we brought to bear on the 10th of January of '96, which says l 15 that all devices in use at that date have to comply. 34.20(f) i 16 does allow for an alternative test on the torque test using the- !
17 value that is representative initially in the rule we have on 18 torque tests that complied with ANSI standards, but literally 19 was -- the equipment was not designed to be torqued to that level !
20 of tolerance required by the ANSI standards.
21 So, that gives you a review of 34.20. It tells 22 you what we've done to date and why. Hopefully, it sets the 23 stage for our concerns about 34.20. And let me reiterate that as !
l 24 we move into the discussion of associated equipment, there are l j l
l 25 several things I would challenge you to help me out with. How '
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(G 1 big of a problem is it? You're going to hear some of the 2
petitioners' concerns, what their thoughts are about the validity A
of some of those concerns. Do you believe the problem is big 4
enough to warrant a rule making initiative to deal with it? By 5
contrast, have you dealt with an inspection or guidance space?
6 What can be done to try to align the proce 2 that we use with the 7 process that the Agreement States use?
8 The ANSI standard. As I searcned through this, I 9 come back to one very striking thing. I go back and I look at 10 the ANSI standard in 1980. I think one of the things that got us 11 the path that we're on is that the ANSI standard defines 12 something called a gamma radiography system, and it includes O
13
) associated components. Later in that standard, it describes 14 source assemblies and then lists a series of tests which have 15 become embodied in 34.20. Now, I heard that from even those who 16 participated in the ANSI standard committee that it was never 17 intended to address associated equipment. Well, I hear that and 18 I'm very receptive to that. I guess I'm troubled by the 19 definition because it's rather explicit, and did we misread it or 20 did we just misapply it or what's causing that confusion.
21 Another thing they talked about a little bit that 22 7,d like to know more about is that -- and I'll share it with 23 you when time comes when we're in the discussion, I think it's 24 clear on our regulations that we do evaluate associated equipment 25 as part of the sealed source and device review. And I'11 be more l JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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O 1 explicit when we get to that part of the discussion about why I 2 believe that and what is the regulatory basis'for doing it. But 3 I guess I would -- it would be helpful to me to hear if you have 4 any thoughts about why there's confusion on that point; why 5 associated equipment should not be evaluated as part of the 6 device review in which we say, okay, tcis particular system using 7 these particular components -- in fact, this particular 1
8 associated equipment meets the requirements of 34.20 or 32.210, 9 which is the criteria that we use to evaluate sealed source 10 devices. <
11 And really, and the biggest question that I would 12 like some' help with is is it okay -- I mean, is it safe? Does 13 it -- is there a public health and safety. problem if 14 radiographers interchange this associated equipment? In other 15 words, I've got a camera system with particular components. It's
! 16 undergone a particular review against established criteria, and 17- now, a radiographer working somewhere is going to interchange 18 those components. Is that okay? Can that be done safely? Is 19 there a problem? And if so, how much of a problem is it? If 20 it,s not a problem, why is it not a problem?
21 And I guess the closing thought.would be tell us 22 what we need to do on one hand particularly of safety in this 23 area help you to continue to prevent overexposures in your 24 industry and yet at the same time be reasonable and be ,
25 technically valid. I think good science is always helpful.
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1 So, anyway, there's some -- I charge you with l
2 those thoughts. I hope thas background will set the stage. I'll 1
3 be happy to entertain questions that you might have before Don j 4 does his presentation. Any questions on what I had to say?
1 5 Fantastic. Thank you.
6 MS. TROTTIER: -Thank you, Larry.
l I think before Don l l
7 starts, I'm going to offer the opportunity for about a 15 minute 8 break. Would that make everybody happy? Okay. So, we'll meet 9 back here at 9:45.
10 (Recess) 11 AFTER RECESS 12 MS. TROTTIER: If everyone can reassemble, we'll get 13 back on schedule. You all got a break because I never changed my 14 watch from eastern time. When I said 10:30, I said oh my, we're 15 going to have-to give these people a break. And then when I 16 started saying what time to come back, I realized it's not 10:30.
17 What the advantage was, it gave the sound guy a chance to work on l
18 the microphones. Now, they'11 all be functional.
19 One thing I wanted to mention, we did send a sign 20 up sheet around. So, it should be around somewhere. Hopefully, l 21 it will eventually make it back up here. If for some reason you 22 didn't get on it, we'll leave it up here. So, some time today, 23 stop by and put your name down.
! 24 We are having.this meeting transcribed as you can 25 tell. We will make a transcript available. The transcribers I
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1 O I have told me that they can give me a Wordperfect disk. I don't 2 mind mailing out disks to everyone on earth. I do mind mailing 3 out hundred page documents, though. So, I will be less inclined 4 to offer a free service of mailing out a document as I will a 5 disk because it's something that's easy, and it doesn't take a !
6 -lot of secretary's time to reproduce, reproduce, reproduce. So, 7 if you have a capability or you want it E-mailed, that's even 8
better. That takes even less effort. We can do that. But what .
9 I'm going to ask you to do is either give me a piece of paper 10 with your address or however you would like it before the day is 11 over is probably the easiest thing, and I'll try and get that to 12 you as soon as we can.
Q -- 13 If you don't have any means to take it other than 14 paper, we'll just do it on whatever basis is available. If we do l 15 get only a few requests, well, maybe we will make copies. In 16 general, the agency's policy is that we put it in our public 17 document room, and anyone can go there and make copies. I 18 realize that is an enormous burden. So, I'm trying to find a way 19 to simplify it, and for us, the easiest thing is to do it by 20 computer. So, as I said, if you're really interested in getting 21 a copy of the transcript, then let me know today via piece of 22 paper because my brain is old and it won't retain it if you just 23 tell me. So, you need to write that down.
l 24 Okay. What I'm going to do now is Don --
25 introduce Don Nellis, who is our primary radiography rule writing
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lG(3 1 person in the office of research who has been doing this for many 2 more years than I have been. involved,.and so, has a great deal of 3 knowledge about our radiography regulations. And he will just 4 briefly walk you through the petition. And the only reason we're 5 really bringing this up is this is really what was one. of the 1
6 impetuses to starting this effort besides the fact that, you i 7 know, while we were getting all these comments at the time that i
8 the January 10 date was approaching, and we thought we'd better 1 9 consider relooking at this, l
10 The' receipt of the petition really kind of i 11 culminated that thinking to the point that maybe it is time to do 12 a reevaluation, a serious reevaluation. And we basically got 13 approval from our upper management to move forward and do such a 14 . thing. So, in these days of dwindling resources, while that may 15 - not seem that significant to us at the NRC, it's very 16 significant. We don't do anything anymore that we don't get high 17 level approval for because we have less and less resources, and 18 so, we have to justify a need to do for the rule making.
19 So, with that, I'll turn it over to Don, and when 20 he gets done, then, as I originally promised, this was an 21 opportunity for you to provide comments. We will shut up and 22 listen to your views, but for now, Don will go through the 23 petition.
l 24 (Talking off the record) l 25 MR. NELLIS: Okay. I'm briefly -- I'm only going to --
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1 I'm not going to talk very much about the petition. I have 2 simply abstracted a few paragraphs on it. I'm going to put it on 3 there and let you read it. If you can't read it, I'll read them 4 to you. I've got a set of copies here. And then we'll go 5 through it, and if at the end of this time, I haven't done 6
justice, Kate Roughan is sitting right over here, and she's the 7
one responsible and she can respond in person to what needs to be 8
going on.
9 Anyway, what I thought I'd start out with, I 10 wanted to make one mention that has to do with this meeting and 11 not nothing as to this. But it's sort of a lead in in the 12 American National Standard. They all have one of these. They're A
) 13 sort of a caveat. And it says:
14 The American National Standard is intended as a l l
15 guide to the man -- to aid the manufacturer, the consumer, 16 and the general public. The existence of an American 17 Standard does not in any respect preclude anyone, whether he 18 has an approved standard or not from manufacturing, 19 marketing, purchasing, or using products or procedures not 20 conforming to the American National Standards and so on and 21 so forth.
22 In other words, it's the thing that the 23 manufacturers, users, and so on need developed way back many, l
24 many years ago to kind of protect the American public. And they 25 tried to tell us and say, well, look, we can't cover all the k,)
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i i O 1 bases, but let's make sure we identify this and we identify that i 2 and we identify some other things here.
3 And I remember'back in the early 60s when I lived I
4
-- I guess it was the late 50s that in Texas, there was some big j 5 to-do window air conditioners. They had everything. They had I 6 one ton units, five ton units. Some of them were BTU units.
7 others were horsepower units. There was no correlation at all, i 8 and the industry was getting a very bad name, and then of course, 9 then they got together and they came up with an American Standard 10 for the particular things, and they itemized just a few things. )
11 So, everybody would meet that standard, and they decided which 12 ones would be used.- And I think they came out with the term 13 " BTU", _as I recall, and that's the way you bought) your units.
14 Now, with that, I'll go on with the Amersham I i
15 petition. There were just two requests that the NRC amend the I 16 regulations or move the references to the associated equipment.
17 And the other one was that we should have additional inspection 18 4
and maintenance requirements. Now, the old 34. 8 is now 34.31 in 19 the final one, and there are some additional parts in there, but 20 1,m not sure it's going to cover everything that people wanted.
21 This is the discussion of the thing.
22 Can everyone see that? NRC has, expanded its 23 th 9 3'1. '.L 10 -
review to cover associated equipment ef--32.20=With- 210, 24 rit' r, without making any formal rule making. And the l
25 petitioners understand these committee members agree that this iO JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 4 shouldn't be provided a regulatory approval document checklist.
4 2 petitioner claims Agreement States don't require associated i 3 equipment to be listed and approved on the device registration ,
4 ' sheet, and this puts them at a competitive disadvantage since 5 they are a NRC manufacturer -- NRC licensee, I should -- excuse 6 me. Petitioner claims that there is an undocumented requirement 7 which states that the user or manufacturers cannot perform their ,
8 own certification on associated equipment.
I 9 And then since -- of course, since January 10th 10 of 1996, all the associated equipment has t.o comply with the 11 requirements of 34.20, and it produces some negative impact.
12 First of all, since collimators have never been tested, there's 13 no standard for collimators. A lot of people to be safe are just 14 not using collimators, which is a ridiculous sort of situation.
1 15 NEC licensed manufacturers must be able personally to provide !
16 approved for associated equipment while Agreement State 17 manufacturers do not. So , that's another competitive 18 disadvantage.
19 The enforcement of regulations, Larry already 20 mentioned that. There's some inconsistency among the various 21 regions in the way to interpret the regulations in the Agreement i does th,v9f %
j 22 States. So, that one inspector dWt thi ' one way and one uY
- 23 inspection does them a different way. Some licensees are unable -
j 24 to radiography. For instance, there are no standards that 25 provide for jet -- "J" tube 5 jet engines) obes, and so on and so
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V 1 forth, and I don't expect there will be. Well, because you make 2 those sort of things for a particular job you're doing.
3 Now, the reasons for the petition. The associated 4
equipment that is currently in use has good operational safety fl-y n ~
5 history. The petitioner believes A22 should be used as guidance' 6 for the associated equipment and not as a regulatory approval 7 C checklist. They also believe that the manufacturer shouldn't be 8
h allowed self-certify that the associated equipment is fit for 9 use. And I don't know what that means actly fit for use".
10 The petitioner notes that there are some specific applications i 11 where ANSI requirements cannot be met. And of course, that's in 12 the case of the aircraft industry, the "J" tubes, and the special
/,.N )
tj 13 kinds of tubes that they need for that work, and I guess there l 14 are other conditions too where you have to manufacture your own.
15 And the petitioner believes that the regulatory 16 review of all this associated equipment adds considerable 17 unnecessary costs. They believe very strongly that a proper 18 inspection and maintenance program on all the equipment is 19 required, including accessory equipment, and this should be made l 20 mandatory. I don't remember now that that is in the final rule, 21 whether anything -- I think is what is meant, and that would be 22 in 34.31. And that's the extent of the petition as presented.
l 23 Now, the comments on the petition, we've only 24 received two comments to date, and here's comment number one.
I 25 This is either his comments. Feels -- and I can't identify them.
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q l- l 1 l Feels the manufacturer-has the necessary expertise to perform the j 2 assessment and they don't need regulatory approval for it. There I 3 are -- there is some equipment that can't meet ANSI-N432 l 4 requirements. That again is the "J" tubes and that sort of thing 5 And for-their particular -- for this particular company, the big 6 impact has been about 35 hundred and that's since January of this 7 year. But the main problem they claim is the different l 8 interpretation between NRC -- between the user and NRC on what 9 constitutes compliance.
10 And we have the one from the second person, who 11 said that he's been in the radiography business for over 30 12 years. And he said it's shown that associated equipment properly 1
- '13 maintained and used presents no safety problems, and over the 14 years, the only incidents he's been involved in were obviously 15 misuse of the equipment. And he goes on to say that this is l
16 placing a tremendous economic burden on the industry, and the 17 associated equipment needs for specialized jobs is not unsafe 18 merely because it can't meet N432. And then again, he's talking l
19 about "J" tubes and various types of the things for the industry 20 that way.
j 21 So, that's the end of what I have to say here 22 unless someone has a question or two. Kate, did I do a 23 reasonable job or you would like to add something?
-24 I can add a few more things. Just like MS. .ROUGHAN:
4 25 to clarify one point in the petition. When we did the petition, f JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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lO 1 there was inference that the Agreement St tes were treating the 2 registration documents differently, and that was just based on F
3 conversations with customers and some regulatory authorities and
.4 things like that. Since the petition has gone in, we've been .
5 told specifically that the other Agreement States are requiring 6 that all the associated equipment be listed on the documents.
7 So, that is a little bit different than what was originally in ,
8 the petition.
9 Our main concern for doing the petition, we're 10 looking at the current state of the industry. The industry now 11 actually has a very good safety record compared to 10 or 15 years 12 ago, and what really bothered us is that the regulations that are 13 coming into place now are based on the fact that 15 years ago, j 14 the radiography industry did have a lot of overexposures, a lot 15 of equipment that wasn't manufactured to any specification or 16 things like that. But with the advance of a lot of things from 17 the past few years, a few specific examples is just the 18 requirements for the camera itself, automatic locking device and 19 the ANSI standard for that camera. That has improved the safety ,
1 20 of the industry.
21 The other requirement is that the source and the 22 drive cable connection have a positive connection so you don't 23 have a disconnect. The majority of source retrieval incidents 24 were due to sources becoming disconnected in the field. That
! -25 doesn't happen anymore. We rarely get a call now to go out on a 1
O :
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( l source retrieval and assist any customers. So, what concerns me l
2 is that'the NRC is implementing a lot of, in my view, excessive 3 regulations for the associated equipment based on data from 15 4
years ago, where it's not as appropriate now as it was 15 years l 5 ago.
l 6 So, we put in the petition just to bring to light 7
several issues that we had come across with the final date of 8 January 10th, 1996. And just to kind of summarize the petition, 9 we strongly feel that there does need to be some minimum criteria 10 for associated equipment. You can't just put garden hoses out 11 there in the field, but the fact that it's associated equipment, 12 it's not the primary vehicle for the source cable. It's not 13 the -- a critical component to safety. It assists in the-source 14 travel and things like that, but it's not critical to safety. We 15 feel that the associated equipment as long you meet some minimum 16 criteria and that can be the ANSI standard which is actually 17 fairly good guidance. We designed the standard several years 18 ago. It's still good guidance, but in some cases, it's not 19 applicable.
20 The jet engine probes are not going to pass the 21 crush test that's required by ANSI, and yet, they're fit for use 22 because they're used in a protected environment. You can check 23 them out prior to use to make sure they are safe to use. So, j 24 what we're pushing for in the petition is that, again, sets a f
25 minimum criteria, whether the ANSI or some other standards that lO JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 are necessitated by the environment that the associated equipment 2 is going to be used in and let the user make the assessment of 3 whether or not it's safe.
4 Now, right now, associated equipment requires us 5
to meet that for regulatory safety review, where internally in 6
the company, we've already done testing, engineering analysis, 7 whatever it may be to prove that it meets ANSI or otherwise fit 8 for use. The regulatory review does not seem to add any added 9
benefit because again, there isn't from historical perspective, 10 there are not incidents due to the associated equipment unless 11 it's been improperly maintained or used when it's in very poor 12 condition.
f (3) 13 So, we're pushing for a self-certification much 14 the way for a DOT Type A shipping container. You're authorized 15 to ship 27 carriers of iridium, 11 carriers of cobalt in a Type A 16 container. By the DOT and NRC standards, you're allowed to do 17 self-certification on the testing, and that series of testing is 18 12 or 15 tests the container has to meet. It goes out into the l
19 public domain into the transportation cycle. There's no 20 oversight on it once it's in the transportation cycle, and yet, l
21 in that respect, the shipper can do self-certification, whoever 22 the shipper is. It can be anyone in this room with a Type A 23 package. They can do the self-certification, keep that 24 documentation on file for one year.
25 And yet, for this associated equipment that's not LJ
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1 critical to safety, we're required to -- there is required to be 2 a secondary review by the regulatory authority to prove that's 3 fit for use where years of experience in the field of the 4 equipment being used and just having people meet minimum 5 standards on their own and doing self-certification will prove 6 that it's -- will prove that's safe for use.
7 So, that was the main impetus behind the petition.
l 8 In addition to the regulatory review, we initially did get system
)
9 approval for the controls and guide tubes for the cameras.
10 Unfortunately, we looked at the whole realm of associated )l 11 There equipment. There's no way we can cover all the equipment. )
12 are' jet engine probes that are designed on a daily basis by 13 people based on the specific application. "J" tubes are
- 14. designed, rigid source stops. If there's a unique application, i 15 somebody has to manufacture a piece that can be used for that 16 radiography.
17 And when I'm done with my comments, I think we 18 have someone here that has some slides on some of that equipment 19 which might help demonstrate that. So, there's just no way we 20 can actually cover every single piece of equipment that needs to 21 be used out in the field. It's just added time to get approved, 22 economic burden, all those associated issues.
l 23 And just -- Larry, you made a comment about the i
24 inspector instructions in terms of how you look at the system as i
25 a whole and make sure it's compatible. That's a great idea. The JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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,a 1 only problem is, it still raises a question of compliance. We as 2 a manufacturer, people as licensees, there's still a regulation 3 in place that says it has to be approved. So, in a sense, you're 4
telling the inspector to look the other way. Where does that 5
leave the licensee? I like the approach. It's just it still 6 puts everyone in kind of a gray area as to compliance.
7 And I will be quiet for now because I know all the 8
users probably have quite a bit to say about it.
9 MR. CAMPER: Kate, I have a question. The -- two 10 questions, actually. The first one deals with the question of, 11 you know, the exotic uses like, say, "J" tubes and aircraft 12 engines for example. The exemption pathway, is that the viable 13 alternative? Is it working? I mentioned I had very small 14 numbers of exemption requests. So, I guess I'm interested in 15 what your thoughts are as to whether or not the exemption pathway 16 that we're using right now for those type of users is a viable 17 alternative, and if not, why not.
18 And then the other one is the idea of the 19 manufacturer determining. One of the points that you made and 20 one of the points that one of the commenters made was that the 21 manufacturer could determine. I guess my question is, as I 22 understand it, from a practical standpoint is that there is a --
23 associated equipment is being interchanged in some cases. And I 24 guess my question is, how would you as a manufacturer be able to 25 do that when you may or may not know what associated equipment is fq
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1 being interchanged by the various radiographers in the field? :
i 2 So, how would you do that and what would be your 3 basis for requesting that your client do that? I mean, you would l l
4 not have a regulatory authority to do that. So, it would seem to 1 l
5 me that your equipment users may or may not choose to share with l 6 you the various associated equipment that they're going to use.
7 So, how would you do that or any other manufacturer for that 8 matter?
9 MS. ROUGHAN: Well, for the first question. I do 10 believe and I'll let again the industry speak for itself. There 11 are quite a few cases where the unique applications are being 12 used in equipment noncompliant with (indiscernible - too far from i
(A,) 13 mike). Oh , I'm sorry. People have not just gotten the approval.
l 14 In the second case, again, I do believe there should be minimum 15 standards for the associated equipment, but again, and if all the i 16 manufacturers meet that -- and when I say manufacturer, I just 17 don't mean ourselves and NRC, I also mean any of the other i 18 people. The airlines sometimes make their own jet engine probes.
19 other licensees make their own specialized tools and things like 20 that. They can be considered the manufacturer, again, as long as 21 they meet the minimum criteria.
22 In terms of compatibility issue, it's not 23 addressed now with NRC. We have asked the NRC over the years for 24 compatibility -- to address the compatibility issue of sources 25 and different devices and things like that. It's not addressed J
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l now. So , I don't think we're introducing any new safety problem.
2 I MS. TROTTIER: Okay. What I'd like to do is open up :
3 the floor and tell you how I'm hoping this works. We have two 4 sets of mikes. I've turned this one around because I'm sure none j 1
5 of you want to stand with your back to everybody just to face us i 6 three regulators here. So, I've tried to turn the mike so that j i
7 you'll be facing the group as a whole. The reason there are two l 8 l mikes is one is, of course, for amplification. The other is for j 9 the transcriptionist. We do have a slide projector. We also 10 have an overhead projector. Anyone who wants to use them is 11 welcome to do it. There's a lapel mike there that might help a 12 little if you're going to use the projectors and it's easier then l
O 13 l V for both the transcriptionist to hear you and for the rest of the 14 group to hear you.
15 I would also ask that you try to be brief in case l 16 there are other people who have something to say. You know, if l 17 there's -- if you want to elaborate at length on something, then 18 maybe you could do that later on. We are going to be here all l 19 day. So, we do have plenty of time, I think. But I just want to 20 make sure that everybody gets a chance because we did decide to l
21 limit this to one day. So, I want to make sure everybody gets a 22 chance to make any of the statements that they want to make.
23 So, at this point, I'm going to open up the floor.
L 24 7,11 try and control the number coming up, but as far as I'm 25 concerned, this is your part of the program. So, feel free to O \
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1 express anything you want to. I would suggest and it's not a 2 necessity, but if you enunciate your name clearly, it will make 3 it easier for the transcriptionist. And also, if you try to 4 speak clearly. You have to remember some of this is fairly 5 technical, and it makes it easier for them to understand if you 6 clearly enunciate things rather than use a lot of jargon that 7
might end up coming out as gibberish on the transcript.
8 So, we'll review the transcript and try and 9 clarify anything that's confusing, but this is new stuff to most 10 transcribers. So, be patient with them. And at this point, I 11 will shut up as we promised and let you speak. Go ahead.
12 MR. SPEAKER: My name is George Johnson. I am ,
i (gQ 13 radiation safety officer with Capital X-Ray Services I 14 Incorporation, Tulsa, Oklahoma. We have been an NRC licensee for 15 31 years. I have ten years experience prior to that as a 16 radiographer for a number of firms in the United States.
17 What I brought is a set of 26 slides that pretty 18 well tells the story as to where the industry is as far as 19 associated equipment. Not only the airline overhaul and 20 maintenance industry that needs the jet engine probes and need it i
21 today, not three months from now, but today for a particular 22 engine, but those of us involved in the petroleum, chemical, 23 power and light industries where we don't know from one day to 24 the next what type of pressure vessel we're going to be handed, 25 what type of tower we're going to be handed, what type of
! i V
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l t 1 structure we're going to be handed to radiograph, and contracters 2 don't wait. It's as simple as that.
l 3 So, in a lot of cases, we must also be able if 4
allowed to construct, test somehow if necessary, but to construct l 5 and to use some associated equipment that is not being 6 manufactured by any of the manufacturers.
- Their inventory would i
l 7 be horrible, and I think these 26 slides will show that. !
8 (Talking off the record) l- 9 MR. JOHNSON: First of all, this is not an 10 advertisement for any particular exposure device system 11 manufacturer. It just so happens that at this point in time, all 12 of the equipment that my firm owns is Amersham manufactured, but 13 I have tested both the Source Production equipment, the new 14 equipment, and the Industrial Nuclear, and I find both of those 15 particular manufactured items to be very effective for use and 16 just as safe in my opinion as the one I'm using. It just so
! 17 happens that I have Amersham today.
18 Do I need a mike?
19 (Laughter) 20 MR. SPEAKER: This particular slide is what we might 21 call the approved systems today. One of those two iridium l
22 devices is one that was retrofitted with the new positive locking l
23 mechanism. The other iridium device is one of the newer f
24 manufactured after January 10, '96, and the cobalt unit is one 25 that has been retrofitted. My industry -- our industry had a JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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- 49. j O 1 pretty good 1991, a pretty good 1992, and for about three months, 2 we had a fairly decent 1993. So, I cut -- my business partner l 3 and I cut our salaries and we spent in those three years $92,000 4 on both retrofitting and purchasing the new system. Some of you 5 have spent more than that. Some of you have spent less than l 6 that. I fully well realize that.
7 My problem began when we started looking at other 8 associated equipment that we needed to conduct radiographic i 9 operations. As far back as December of '94, Mr. Burl Nethercutt 10 with American Airlines and I had a feeling that this was going to 11 happen. No one in our region in Region 4 had any answers. No 12 one in Region 3, I understand, had any answers. So, what we did 13 was look at all the associated equipment that we were using prior l 14 to that date, prior to December of '94, and we wrote a radiation I l
15 safety officer's assessment of that equipment. We bounced this 16 off of some people in Region 4. They said that's good because we 17 don't have any answers yet either, and we put those in our file 18 and thought that we were going to be able to continue to use, 19 continue to manufacture certain items ourselves for certain 20 specific applications.
21 These particular type of collimators as far as 22 January 10, '96 is concerned were the type that were only the 23 ones that were approved. Those particular type of collimators 24 that could be attached to an approved source guide tube stop or 25 to an approved source stop which was a dismountable type. And O
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o 1 the top one is a lead one which has some ears cut off of it.
2 It's attached to a dismountable -- approved dismountable source 3 stop. The tubes coming down from the black one are attached to I 4 source stops. The third one is attached to one of the 5 dismountable. And that's where we were January 10, '96. These 6 are fine and dandy for about two half value layers with iridium.
6 7
8 But what we need -- what the industry has got to 9 have is some larger 360 degree collimators and directional r l
- 10 collimators, directional in port collimators, side port 11 collimators for use for long exposures with iridium and for 12 exposures with cobalt 60. Right there is just a very small 13 number of the collimators that I took out of service in January 14 10, '92. That's about half of my collimators that I took out of 15 service. The 527 ray guide Amersham collimators, some of my own 16 design in 360 degree and manufactured, and some side port, they 17 all had the Amersham one inch by 18 connector on them, but none 18 of them were approved.
19 This is -- and the lighting is not real good for 20 this, but this is a picture of a new source stop, unused. This 21 is a picture of a six-month old source stop that has one of the ;
22 approved collimators that's attached with a one-quarter inch by 23 20 threads to the inch set screw, which is very prominent or a 24 thumb screw. You can't use brass because brass and tungsten l 25 doesn't match too well threaded. You can't use nylon because iO JUDI<CIAL TRANSCRIBERS OF TEXAS, INC.
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1 the -- it just will -- the threads turn over on the nylon when l 2 you attempt to attach it. So, what you use is steel, and steel 3 works -- a steel set screw works loose in these collimators, and 4
therefore, it's a continual reattachment and you're eating the 5 source tip up.
6 And it wouldn't matter, Donny, if it was one of 7 your brass ones. Ti'e came thing happens with one of those.
8 Brass is a little harder than aluminum, but still yet, it eats it 9 up. This is a year old one. The damage that occurred. Okay.
10 But a good inspection and maintenance program takes care of that.
11 We throw away a lot of source tubes long before the tube itself 12 or the device connector is in any danger of causing problems.
13 It's usually because these tips are eat up with the dismountable l ,
l 14 type collimators. !
15 Here's another problem. We do a tremendous amount '
l 16 -- a' lot of other people in here do a tremendous amount of 17 pressure vessel type radiography. Pressure vessels, heat 18 exchangers. Tulsa, Oklahoma is the heat exchanger capital of the f 19 world. Houston tried to take it away from Tulsa several yearo 20 ago, but it didn't work. For the past seven years, over 80 l
21 percent of the heat exchangers built in the United States are not 22 being used domestically. They're being shipped overseas. And ,
23 when these people over there want radiography conducted on a ---
w e(d?
!; 24 ., certain g seam, don't talk to them about ultrasound because 25 .it's not going to work.
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O 1 They may also require ultrasound, but they also ,
2 want those well seams radiographed,' and the American Society of ,
3 Mechanical Engineers Construction Code Books have a paragraph 4 that states very plainly the absence of suitable radiographic 5 equipment shall have no bearing on whether it's radiographed or l 6- not; it shall be. When you attach a collimator, even one of '
l 7- these lightweight ones to the end of a flexible tube, you cannot l >
8 '
keep it into position. And most of you are radiographers. So, 9 you know that if you have any movement of that source during the
{
10 exposure, you wipe out a film or a number of films. With a rigid .
11 tube using the same type of positioning device with a collimator, I +
12 number one, the set screw does not eat the stainless steel up as !
13 badly as quickly, plus there's no drooping of the collimator.
14 I cried. I literally cried because right here is 15 ( -
just about 50 percent of the centering devices. , Stainless steel' 16 rigid guide tubes curve to specialty items that we have to have 17 - to do a lot of radiography, and again, we're not given tube. I 18 needed a tube here while back. I called Donny Dicharry, and he 19 is making some'in Louisiana, 432 tested and so on and so forth.
20 Took me two months to get it. Is there a problem? Yes, sir.
21 Another NTD firm did the job with an unapproved tube. Did I.tell 22 on them? No, sir, I did not. There is a problem there because t 23 for all of us that will take this equipment out of service l
24 because it is not approved, there's always somebody else that 25 will damn well do the work with something that's not approved.
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- This is an air tool heat exchanger. They're found t
2 in every type -- this is a baby here. This is a baby because 3 these things are 16 feet long sometimes. They're a box is what 4 it is. They're held together with all these tubes from these 5 holes, big fans, and what they do is remove Leat from certain 6 You find them in water treatment plants.
proces:4es . You find 7 them in power plants. You find them everywhere. And the ASME 8
requirements and the American Petroleum Institute requirements ,
9 require that the well seams be radiographed.
l We have to have 10 tubes for that because the holes in a lot of these, these are 11 threaded later on and tubes are put in and sealed or a plug in 12 the other end, and we have to have a rigid tube that will go 13 inside this to do the radiography.
14 And again, some of these are 16 feet long. This-15 is a baby one right here. And a rigid tube is basically the only
- 16 way this radiography can be conducted. Well, why don't you 17 double wall it. Put that tube on the bottom and shoot all the 18 way through. Because most of these things have four rows of 19 ~
deflector plates inside them, and we want the film to be as high 20 quality-as possible; therefore the less steel we radiograph 21 through, the higher the quality film. Simple as that.
22 And this is another use of the so called "J" tube.
23 I have retrieved a tremendous number of sources in 31 years.
i 24 Most of those are not disconnects. They are jammed tubes where l
25 the radiographer had too sharp of a radius coming out of an item' is JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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O 1 he's radiographing. The source will go past it because the !
i 2 source capsule is usually round, but since the connector and 3 everything is kind of squared off on the end coming back, it 4
. won't come back. So, therefore, you've got a retrieval problem 5 in a lot of cases. The "J" tube stops that.
6 l This is a heat exchanger. It's kind of, dark.
7 This one is 64 inches outside diameter, and there are 1,392 8
condenser tubes. There is an adjoining circumferential seam that 9 must be radiographed on these. The only way it can be 10 radiographed is to lay the thing out for a certain number of 11 film, and you go around the periphery with a tube into the so 12 called tube sheet to radiograph each film separately, somewhat I 13 like they do a burner can on a jet engine. !
.14 In some cases -- I have one coming up -- Public 15 Health and Safety, it is a phosgene reactor. It's not destined
.16 for use in the United States, and of course, when anybody says 17 phosgene, you go back to 1914, 1915, when it was used 77 18 effectively by the Germans. But phosgene is a by-product of a 19 yot of processes, and the client says that that adjoining seam 20 shall be radiographed, shall be ultrasonically examined, 2L etcetera, so on and so forth, and it is from the tube. It is 19 ;'
y)olh 22 feet to that we-1-1 seam, and I have no tube. I have no tube. If-23 I ask Donny or Amersham to build me one that is -- construct one 24 that is approved, I have no idea how long it will take, but I'll 25 guarantee you-that somebody else will radiograph it if I' don't.
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1 A lot of times the manufacturers get in a hurry.
2 They put these exchangers together before they clear up repairs. 1 3 So , we have a lot of so called pick up radiography on them, even 4
weM %_y_
on the longitudinal waF1 seam.
5 Tremendous number -- engineers today are doing '
6 their best, heat exchanger engineers, pressure vessel engineers,
- 7 to take orifices out of their design. Every time you put a 8 branch connection into a pressure containing part, you have a
]
i 9 stress riser that increases the stress on the unit. Every unit )
10 we used to do 20 years ago had a so called manway in it big 11 enough for a man to get in, bring his equipment in, set it up, l 12 put the controls on the outside, and do the work, the ,
13 radiography, from outside in. That is not true today. So many 14 of these units are closed units. They're full of internal i j 15 structures, etcetera. They cut the size of nozzles down to this-
- 16 two inch nozzle.
W c l cl That welt seam must be radiographed.
You can't 17 get a standard guide-tube. Amersham is a little over 700,000 l l
18 thousandths in -- .700 in diameter. You can't get it through.
19 there to do it. So, here again, is a necessity for rigid tube.
l 20 There's a radiographer's problem right there.
l 21 There's a dandy setup. Again, this is one of them with a 22- coupling because we do a lot of three-quarter inch coupling, and 23 the three-quarter inch coupler is too small in diameter for a 24 standard guide tube to go through. So, another tube with that 25 loop at the top without using a "J" tube is a source jamming i
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a 1 problem ready to happen.
2 We also need radius tubes because in a lot of 3 cases, there is not nozzle in the head where you can center in a 4 straight line in some of these units. So, therefore, we have to 5
come in from a side -- now, this was open, but they're closed ;
6 when we radiograph them. We have to come in with a radius tube 7 to center. There are power plants all this country with L 8 inspection ports, three-quarter inch coupling inspection ports 9 about six inches on a main seam line and secondary seam line of a i 10 well that were designed by -- allowed by ASME Section 1 power l 11 boilers to put in so you could use a "J" tube to-do the 12 radiography, and this is that type of radiography.
13 The components of a rigid source guide tube: the l
14 connector, the source stop, and the tube.
l Now, yeah, I've seen 15 people use welded tubing. No , welding tubing should not be l
16 allowed because ASTM A312, 304, and 316, a seamless tubing is 17 available in different sizes.
We need 7/16" diameter, half-inch 18 diameter, 5/8" diameter, and different diameters to be able to no
(.
19 this work. Some of them after they're GTAW welded, and in some 20 cases, some of the people around the country are using -- and I 21 think the airline industry primarily use both GTAW welding and 22 silver brazing. Don't you use some silver brazing on some of 23 them? We do too.
24 Well, since nobody knew what was going on, we 25 thought -- just another cut in the eye -- Region 4 couldn't tell
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- U 1 l us that the way we were reading 34.20, all we had to do was to 2 develop the equipment, conduct the test, put the test results in 1
3 file, go ahead -- the prototypes -- go ahead and use the 4 equipment as long as we had all documentation. We really got 5 fooled on that last information notice.
l 6 But anyway, I stole a little bit of American's 7 basic design for this ANSI N432 $2,000 crush tester, and that's !
8 $2.000 building it ourselves. You want to come and weigh it?
9 You ca? weigh it. Everything is applicable. It's set up right 10 now for the crush testing on a piece of half-inch diameter 11 stainless steel tubing. Here's a front view of it. Mine has a 12 trigger. I shoot skeet, so I decided to put a trigger on the ,
en l l k ,)
l 13 thing like a skeet gun, also to keep people's feet out from I 14 underneath it. i 15 34.20 says kinking test also. Well, the kinking i
16 test for flexible tubes is to put it into a loop, hold one end, 17 and pop it and it's supposed to straighten out. But you can't do I '
i ,
18 that with a rigid tube. So, I went to the N432-9 ANSI standard, 19 which uses a two inch bar for a kinking test, and after we do ten 20 crushing tests, we put the same tube back up for a kinking test.
! 21 And that separates the tubing from the tubing, guarantee you.
22 That's the killer right there. That's the heel of 1 !
23 the item that has to be a certain size radius. It's had holes l
24 drilled in it because the weight has to be evenly distributed 25 between the arm and the hand, and these are not easy to build.
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O 1 American -- I don't know. You know, they've got 10,000 engineers I 2 out there and 15,000 welders, and Burl's was a lot cheaper than
'3 mine was, but anyway, there's the results of crushing kink I
4 testing on 7/16" o.d. stainless tubing, 35 thousandth wall, and 5
three different wall thicknesses of half-inch diameter steel 6 tubing, and the source tube -- source capsule and the cable will i i
! 7 still move freely through it -- will still move freely through i
l 8 it.
9 Yeah, I tested a lot that would not make it. It 10 was not the crush testing that did it. It was that last kink 11 testing on each end. Here is a close up or a little closer view l 12 of the damage that the tubing incurs approximating a 225 pound 13 man striking one of these tubes with his heel on both a vertical 14 and a horizontal movement. He weighed more than 225 pounds in my 15 opinion with this type of damage. Here is a much closer view of !
16 the damage that the tubing will sustain during the test. And l 17 again, that dummy source assembly on a cable must still move 18 freely through after the testing for that tubing to be approved 19 for use unde [ 432-80; 20 Well, I needed a tensile tester. That weight that.
21 has the OSHA approved colors on it is 112 pounds "X" number of 22 ounces. It's supposed to equal 500 newtons. It's threaded at 23 the bottom, and a solid stainless steel tube of 5/16 diameter, 24 the length of which is according to the length of tubing we 25 tensile test. The black item at the bottom has an exposure v
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- device connector on it. We have a 20 foot cased hole in the 2 floor, and we lower that tensile weight through the tube at about
]
3 7/10 of an inch per second until it impacts the tube end, the
)
4 source stop, allow it to rest for -- it's either ten or 30 l
5 seconds; I don't remember now -- 30 seconds, I believe, and then l
6 repeat that test ten times.
7 We did not on -- we tried several things here for
'I 8 the funnies of it.
l We did not even drive a tip off using lock 9 type industrial adhesive to just glue them on. We did not' drive-l.
10 any of the tubes -- the tips out that were GTAW welded or any f
- 11 that were silver brazed. Now, some of those tubes out there that !
4 I i 12 people are still using that's got a rubber plug in the end or !
13 something like that, you're going to drive the end of it out. i 14 But this particular tensile test from 432-80 is checking the 15 source stop, the tip; it is checking the well; it's checking the l
16 -- it's putting tensile on the threading connection to the 17 exposure device, and that connection weld to the tube itself.
18 - Well, I checked with Amersham about an automatic 19 exposure control to do the 20,000 cycle test, and they hit me s 20 with 15,000. And I had alrea'dy spent'$15,000 on tubing material 21 and all of this business and the crush tester and the tensile 22 tester, and I said whoa back. So, I talked to Region 4 and I was
- 23 told do something different, maybe. So, I did. I did a, torque 24 test. This is.a torque wrench that was fitted with an Amersham 25 "T" handle. It is two inches longer, so therefore, I wasn't JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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!O l 1 looking for a quantitative amount of torque, but regular -- but a 2 comparison.
3 Thirty-five feet control unit, 28 feet approved 4 flexible tubes, right at 50 inch pounds to take the source out of 5 the exposure device "S" tube.
j Right at 14 inch pounds of torque 6 to -- for that source capsule and drive cable to travel 28 feet 7 to the stop. And I'm sure there are some radiographers in.here, 8
and everyone of you know that if you're cranking fast, doesn't 9 matter by hand or with a reel, and there is an overtorque, what l 10 you might call a follow through at the end when you hit it, and 11 that generally jumps up to approximately 100 to 125 inch pounds 12 of torque when the source hits the end of source stop.
13 We did the same thing with the same control unit, 14 different exposure devices, but with stainless steel tubes and i
)
15 found not'one bit of difference in torque, even with the radius !
16 tube. !
17 l
We need very badly in my opinion this 34.20 to be )
18 amended in some manner to remove the references to associated ;
19 equipment in the manner of testing because again, it's not the 20 airline overhaul and maintenance or the jet engine industry that 21 needs these specialized tubes. Those of us in the petroleum, i
- l. 22 - chemical, and power and light industries also need them, and 23 we're not given the time. We're not given the time in a lot of >
24 cases to do that.
25 I went a little bit further. I've got a couple JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 more slides. I bought some approved tubes. They're not cheap. '
2 They're cheaper than I thought they would be. Because I needed 3 my collimators, and I needed them very badly. So, I spent almost 4 $2,000 on re-machining those tungsten -- and this is just part of 5 them -- those tungsten collimators so that I could fit them with I
6 either Amersham 691 dismountable source tips or one of Mr.
7 l
Dicharry's approved source stops. So, I've got my collimators l 8 back in use, and'they are a -- and they should be for all of us a 9 large part of our Alara [sp.ph.] program.
10 I was desperate. I was very desperate because I l 11 knew what was going to happen to my radiographer's dose. Over 70 12 percent of our exposures we use a collimator on, and that's the (g3 13 one we can use collimators on. And if I was down to 30 percent 14 or 40 percent, the dose was going to jump and jump very high.
15 rem --
And we all know where it is today at five gr-am annually. Thank 16 you kindly.
17 MS. TROTTIER: Thank you. I want to interrupt for one 18 minute. Something that I was asked to do, and I failed to do it.
19 The dining room manager has asked whether we are interested or 20 planning on eating here, and I think probably that has an impact 21 on how much food they prepare. So, she indicated that they do 22 have a group rate on the buffet of $6.00 plus tax and gratuity.
23 I guess what I'll do is just ask a show of hands. Who is 24 planning on eating here and then I'll let her know, you know, 25 whether or not we're going to have a large group or not. So, if JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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ll 1 you could do that right now, then I'll try to do a head count l
2 here? All right. Thanks.
3 MR. SPEAKER: What are they serving today?
4 MS. TROTTIER: Oh, that's a really good point, isn't j 5 it? She did tell me. All right. Smothered pork chops, potatoes 6 au gratin, salsa corn, spicy wings, beef vegetable soup, salad 7 bar, dessert, and beverage. That's what on the buffet.
8 l MR. SPEAKER: Can I make one more comment?
9 MS. TROTTIER: Sure.
10 MR. SPEAKER: I will at lunch take sealed bids for that 11 crush tester --
12 (Laughter) 13 MS. TROTTIER: Okay. All right. Put your hands up l
14 again, and you've got to take more time because I'm really slow 15 What does that look like, 30, 40 people?
l here. All right.
16 That's good. Thanks.
17 MR. CAMPER: George, I have a couple of questions for 18 you. By the way, I appreciate your comment on the trigger. I'm 19 also a skeet and sporting clay shooter. So, I understand where 20 you're coming from. I think what you did an extremely good job 21 of articulating is that there are unique needs that require 22- custom equipment. It's got to be done in a timely manner, and 23 there's competitive pressure, all extremely viable and valid 24 arguments. Now, on the other hand, you did comment that -- I 25 think you were referring to a particular construction of a n
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l lO 1 particular tube -- some people will do it soundly and some will 2 not. And I think that's probably a valid statement as well.
l 3 And I guess my question is if we pick up the idea 4 that the petition made, for example, the idea of self-certifying, 5 what -- could radiographers do that, and if they were to do it, 6 if it's not the ANSI standards that apply because of the 7 uniqueness in particular, because the timeliness tells you there 8 may not be other sources available that meet that criteria, and 9 they may not even work at all. I guess my question would be can 10 radiographers be expected to reasonably do that, and if they l 11 were, against what criteria?
12 MR. JOHNSON: Some, I believe, yes, sir. But I'm going 13 to have state this. I don't care how many regulations anybody 14 makes. The industry is only going to be so safe. There are 15 going to be continued overexposures, etcetera nationwide. It's 16
-f just going to happen regardless or regulations. I'm a firm 17 believer in the fcct that it doesn't matter whether it's a small 18 firm or a large firm, that the radiation safety -- we know how
~ l 19 live those radiation -- you know, you can be personally liable i 20 now.
21 So, if RSO and the management of that company is 22 -willing to let this equipment be used and let them be liable for 23 it, I'm willing to be liable for mine. I'm sure American 24 Airlines and other airlines are willing to be liable for theirs, l 25 maybe NQS, what have you. And guidelines for the manufacturer of f.
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O 1 these -- the only guideline that I've seen, it cannot be welded.
2 It cannot have a weld seam in it that could catch a source.
3 That's about it.
4 There is one particular application that I can i
l 5 te'11 you about real quickly that is the only way that a wedd i
l 6 particular we R seam can be radiographed, and these are in every 7{j i
7 nuclear plant in the United States, and that is the feed water I
- we.ld l
8 heater. And they have a petr seam that's about 15 feet down into g-9 the unit, and the tubes are less than one-half inch in diameter l J
10 on the inside. There is no stainless tubing of the stop ball.
11 The stop ball on Amersham's is about 3/12, 3/15 in diameter.
12 It's a little less on Mr. Dicharry's. But anyway, you need about 0
Q 13 3/18 to maybe 3/25 on the inside diameter. They can't do it with 14 the tube.
15 So, what are they using? They're using teflon.
/ l 16 Now, that teflon tube will collapse. However, when they can 17 insert that down into one of the heat exchanger tubes and as the l
18 isotope goes through it, it opens the teflon up. There's 19 . virtually no friction on it at all down to this 15 feet or so i
20 where this.well seam is, and they have to make several exposures.
21 So, they put.it in and make an exposure, take it out, move it,-
l 22 what have-you. It's the only way it can be done. And the Power ]
23 and Light people, they will not allow -- yes, they will allow j 24 ultrasound, but in addition to the radiography because there's a 25 particular type of well discontinuity that occurs very frequent 1y' JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 w e lds - 'r~
l on these yeLis; And an ultrasonic operator can't tell what it 2 is, but the radiograph can.
j 3 But there's an application, and I know that i t
4 particular -- the particular firms involved in that type of 5 radiography did not ask for any exemptions because it wasn't 6 steel, it wasn't a rigid type tube. It was a teflon liner. ,
1 7 Again, I'm going to go back and say I have retrieved a number of I 8 sources over the years. We've used these stainless steel tubes, 9 and I have only had to retrieve one isotope that was jammed in a l
10 rigid tube. And'it wasn't the tube. It was a clamp that clamped i 11 around the tube that exerted just enough pressure to keep the 12 source from coming back. Very simple to retrieve.
13 I think the history of the rigid tubes, the "J" 14 tubes are very, very good. The garden hose variety, no.
15 MR. CAMPER: You've been a RSO for a long time. Can l
16 you in a few words characterize what you think the safety l
j 17 significance is or is not of the development of these various 18 custom guide tubes and so forth. Is there a problem here or not 19 from a radiation safety standpoint?
20 MS. TROTTIER: Can I get you to go to the mike. I'm 21 sorry.
22 MR. JOHNSON: There's always safety significance in my 23 i opinion if whatever is used in associated equipment is not l
1 24 manufactured and inspected. You know, it's unbelievable to me at 25 what I see in some quarterly inspection and maintenance programs.
O V
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O 1 They're on paper. l It's also unbelievable at what I see around 2 the country in some daily radiographer's inspection programs, and 3 there is a thrust. There is a safety thrust in those two l 4 avenues.
5 MR. CAMPER: The other question for you is, you know, 6 again, if one goes back and looks over time, there have been many 7 adjustments in this industry over the last ten years. One of I
8 things that I'm struck by by what you have said is that the i 1
9 associated equipment -- you know, since 1992, manufacturers have l 10 been developing f,ystems that met these requirements and so forth.
11 But what I'think I'm hearing you say and correct me if I'm wrong 12 is the associated equipment problem is not an issue that's going ;
13 to ultimately disappear. I think I heard you say that literally, 14 manufacturers can't maintain an inventory or may not.even know 15 what the need is to sustain such an inventory, which to me 16 translates into the fact that the associated equipment is not a 17 dying issue. It is an issue that will continue assuming the 18 industry remains viable.
19 MR. JOHNSON: Yes. And I think we're going to have to 20 go to -- a little further with that. If you're only 21 manufacturing five items and you're only potentially liable-for 22 five items, that's one thing. But any manufacturer that 23 increases that number in inventory to 25 and 30 and 40 different 24 items increases their liability sometimes way out of bounds. If 25 I was personally an exposure device manufacturer, you couldn't JUDICIAL TRANSCRIBERS OF TEXAS, INC. ;
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- 67. l O 1 pay me enough money to make you a rigid guide tube because of the 2 liability. It's.not that the tube won't do-the job. It is the 3 potential abuse and the potential damage that can occur to it, 4 maybe not in use, maybe in use. !
But because of ineffective 5 inspection and maintenance programs.
6 MR. JOHNSON: And use.
7 MR. SPEAKER: And use. Yeah.
8 MR. CAMPER: So, that, then, would mean that a possible ,
l 9 i pathway, for example, might be removing the associated equipment 10 to Part 34, replacing it with a much more stringent requirement l 1
11 for maintenance and inspection. Now, against what criteria?
12 What could we make -- what could we bring to bear as appropriate l 13 in maintenance and inspection criteria?
14 MR. JOHNSON: Well, number one, both -- all three 15 manufacturers of the exposure devices in.their operations manuals 16 tell you what to .4ok at, what should be looked at on the daily 17 inspection and on the quarterly inspection. And most licensees 18 if they do a cookbook type program, they kind of go down the line 19 as to what they're going to do on a quarterly basis and a daily 20 basis by'the radiographers. So, you know, is it free -- is it 21 free and open? I know Mr. Nethercutt before they use a jet 22 engine probe, they use a dummy source assembly to make sure it's 23 open to the end. We do the same thing. It's on the daily I 24 checkup. We don't do it between every exposure because sometimes 25' we have too many exposures to do that. But at least, when that
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U 1 radiographer checks it out, it's open, it's clear. He looks at 2
wel4 s wdd 5 _ >
the weF11r. The welts are fine, so on and so forth.
3 MR. CAMPER: The manufacturer's checklist makes sense.
4 What about the unique device that you are literally -- and you're 5
manufacturing some of these things in the shop. The 6 manufacturer's guidelines would not apply.
7 MR. JOHNSON: No , they will not.
8 MR. CAMPER: So , in that case, then, what types of 9 inspection criteria -- maintenance criteria?
10 MR. JOHNSON: Again, because we're basically talking 11 about either collimators or we're talking about a rigid or maybe 12 a flexible type tube, are they open? Are the attachment C
t 13 connections threads okay? Does the source stop have a hole in it wel 14 7 or is the ,1-broken? It's relatively a few things because 15 you've got something you're going to attach to either an exposure 16 device or attach to an approved flexible tube to take the source 17 from here to here through a hollow cylinder or a collimator to a 10 certain point. So, there's just very few things that's necessary 19 for inspection.
20 MR. CAMPER: Do you do operations in Agreement States?
21 MR. JOHNSON: Did.
22 MR. CAMPER: For reciprocity?
23 MR. JOHNSON: Did.
-24 MR. CAMPER: Did?
25 MR. JOHNSON: Yes. And I still do. I still do JUDICIAL TRANSCRIBERS OF TEXAS, INC. I Fax (713) 462.3042 . Office (713) 462 6434
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l O 1 reciprocity, but I had a Kansas and a Texas license for years 2 until 1984, when the petroleum industry did a (whistle).
3 MR. CAMPER: Have you ever had -- have questions ever 4 been raised in any of your inspection and reciprocity scenarios l
l 5 with regard to the associated equipment?
6 MR. JOHNSON: No, sir.
l
! 7 MR. CAMPER: Do you have any impression as to j 8 generally, how the Agreement States inspectors go about looking l \'
9 at these things?
10 MR. JOHNSON: From what I've heard since January, in 11- most cases, they're not even looking at anything. I've heard of 12 one incident in Texas, but this was because the tube had been
() 13 approved, apparently, by the NRC for use on a jet engine. But it 14 had only been approved for a particular airline in overhaul and I
15 maintenance, and there were subcontracting and somebody else was I l
16 using the tube instead of them. And that's the only incident I
17 7,ve heard right there.
18 MR. CAMPER: If were, for example, in the solicitation 19 of comments and called for development of guidelines for 20 maintenance and so forth for inspection, what organization or I 21 what approach would you then recommend that we could run such 22 guidelines by if we were considering including those in ultimate i 23 (indiscernible) criteria?
l l i 24 MR. JOHNSON: I think the same thing the state of Texas 25 did when they tried to put together the examination. Bring some lO JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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O 1 licensees together from different type of industries. We're 2 still talking about collimators and tubes. That's really what ,
3 we're talking about is collimators and tubes. And get some ideas 4 from them in a public meeting.
5 MR. CAMPER: All right. Thank you very much.
6 MR. NELLIS: Can I ask a question, please? I guess I 7 misunderstood a little bit some of your talk there, but it seems 8 to me you said at one point that you required a certain type of 9 tube, and you were not able to get it from Amersham; you were not
! 10 able to get it from Donny Dicharry. But somebody else went out 11 and made something and they did the job, and presumably, they did 12 it safely and so on. I take it that you didn't want to do this
("%
Q 13 because you were afraid of losing your license. I gather there i 1
14 are other people --
i l 15 MR. JOHNSON: I have never been afraid of losing my 1
l 16 license.
17 MR. NELLIS: All right. Well -- '
l 18 MR. JOHNSON: My opinion is to comply, comply with the l
i 19 regulations --
20 MR. NELLIS: Right. Okay. But what I was going to ask 21 is how do you -- I'm asking for suggestions when NRC here. Is --
22 if you run into an -- if any of these people out here run into a 23 condition where they need some particular piece of equipment,.it !
24 may take -- you'll go through a series of tests. It may take a r
i 25 couple of months, and they've got to get a job done right away.
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O lO 1 Is there any particular guidance that you could give us or tell 2 us how you best do this, who to approach, what needs to be done 3 on these tubes and so on, and whether we have to run testing or l 4 not? What would you do in those conditions?
5 MR. JOHNSON: Well, frankly, I don't care whether it's 6 an ANSI document or anything else. We know that the source l 1
7 capsules are certain diameters. It's basic. That the stock l l
8 balls are certain diameters. So, whatever the inside diameter of 9
one of these tubes is, it's got to allow that to go through. So, 10 that is the first guideline for manufacturing either a rigid tube !
11 or a collimator, that the inside diameter must be of a certain 12 size. The attachment of how you put the connection and the I i /~~T 13 l!d source stop on. And I've got six different designs, and this 14 whole industry has used the same designs for years. A plug 15 welded on the end, etcetera, so on and so forth. And what I've 16 seen over the years is that good silver brazing or GTAW welding 17 is probably the very best attachment for both the exposure device 18 attachment piece and the source stop.
19 A very good example is Amersham quit selling 20 fittings -- what, Kate, four years, two years ago? They won't 21 sell me any of their fittings. So, I'm having to make those 22 fittings or I was, machine them from stainless steel. Of course, 23 you know, you can't patent a one inch by 18 thread. So, to me, 24 ge,s still very -- it's still a very simple thing. Something has 25 got to be a certain size inside diameter.
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I O 1 The flexible tubes. I They're fine when they're 2 new. The polyvinyl coating -- when that polyvinyl coating is put 3 on those tubes, it's hot, and you've got fingers of the polyvinyl 4 coating that goes down into the flex and that's beautiful.
5 They'll pass any crushing test and any kinking test. But a year l
l 6 old tube, there are no polyvinyl fingers down inside that, and I 7 can crush any of them in ten crushes. Of course, the prototype i
8 passed. So -- and the eating up the tips on and so forth, you 9 know, we still have some potential problems with approved l 10 equipment. It's not going to be solved.
11 The way to solve it is with emphasis on daily 12 equipment inspection by the radiographers and quarterly 13 inspection and maintenance by management. Small guidelines for 14 the diameters, the lengths. You know, you're not going to have -
15 - if an Amersham 35 feet set of controls is only safe with 28 t
j 16 feet maximum length of guide tube, then the collimator or the 17 rigid tube, including the flexible tube should not -- ehall not l
18 exceed the maximum that's allowed for the use of the control 19 unit. It's still very few things to me that are necessary to set 20 up a relatively safe -- because there's no such thing as a 21 hundred percent safe and they never will be a hundred percent l-l 22 safe -- relatively safe for a manufacturer to either design his 23 own collimators, have them built.
24 South Manufacturing, Bixby, Oklahoma has made
- 25 collimators probably for everybody in this room. He's not now.
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- 73. i O 1 He hasn't since January, and then he had a bunch of customers 2 send them back, want their money back. Those collimators, the 360 3 degree and the directional, beautiful collimators. He doesn't 4 manufacture them anymore. Nobody is going to buy them because 5 they're not approved.
6 MR. NELLIS: Seems to me like we're between a crack and 7 a hard place.
8 MR. JOHNSON: Yes, sir.
i 9 MR. NELLIS: If we don't have some standard of j 10 approval, we can't really approve them. And therefore, you 11 can't get them manufactured for anyone. No one wants to 12 manufacturc them because they can't get approval, and people
, 13 aren't going to be able to do radiography. Right? ;
14 MR. JOHNSON: I'm not suggesting this as a suggestion, 15 as an alternate. And I very seldom get mad about any regulation. )
1 16 I attempt to comply with it. But when the regulation told me one l 17 thing and I approached building the testing equipment and testing i 18 it, buying the proper tubing and testing this, and then I'm told 19 that I've got to send every design and 700 and some odd bucks for .
)
20 every design in to get approval, no, sir. I do not agree with 21 that whatsoever. For somebody -- for me to have to pay to l
22 evaluate something that I've already tested to the ANSI document 23 that the NRC references to begin with.
24 Now, I'm not going to test anybody else's tubing, j 25 There's liability again. I will allow other licensees to use my its JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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( l 1 testing equipment, but on their own. I'm not going to do it for l 2 them.
3 MS. TROTTIER: Thank you. All right. Now, I think we 4 need to let others speak. And we will try to be a little more 5 quiet up here.
6 MR. GIBSON: Harry Gibson with H&G Inspection. I'm a 7 NRC license and an Agreement States license. One of the things 8 he left out was what happens when you find a piece of equipment l
9 that's approved and you write the NRC and you tell them this l 10 piece of equipment is not working? You don't get an answer back.
l 11 They don't do anything about it. So, what good is it doing us to ;
12 have equipment tested that when we actually write the letters, i
.g 0 13 tell you that we've had problems with this piece of equipment and l
14 so on and so forth, and then we don't get any answers back.
15 Also, with the automatic locking devices, nobody 16 dreamed of the problems we were going to have in source 17 retrieval. Some " crank-outs" you can't get loose from the 18 cameras. It's been a nightmare. I mean, it's literally been a 19 nightmare just on source retrieval. And yes, we have had some 20 disconnects with the new cameras. I have all three 21 manufacturers.
22 MR. CAMPER: Did you state that it's equipment?
23 (Talking off the record) 24 MR. CAMPER: Is it equipment or is it operator error?
25 MR. GIBSON: No , sir.
4
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i j 1 MR. CAMPER: The reason I asked the question because I l
2 had the impression going back and looking at some of those events 3 and talking to some other licensees, in the beginning, there was 4 some operator familiarity problems. So, was it the equipment in 5 your opinion or was the operator interface issue?
6 MR. GIBSON: It was equipment. In fact, we offered 7 to -- in fact, we invited the NRC in the state of Texas to come 8 to our office. We'd be more than happy to demonstrate the l 9 problems. Nobody ever showed up. Right, David?
10 (Laughter) 11 MR. SPEAKER: So, this equipment is approved. Now, we 12 decided that since this equipment had that problem that we would 13
_) use some other equipment housings that maybe we wouldn't have j 14 this problem to solve our problem. Now, the housings we used, 15 are they approved? No. The only reason because they were 16 manufactured prior to January 10th, 1996. Now, if I bought a new 17 one today from Donny, then it would be approved to put on there.
18 But since we don't get any answer, it's kind of -- puts us in a 19 position of they really don't care. l l
20 (Pause) 21 MR. NETHERCUTT: I'm Burl Nethercutt, RSO, American 22 Airlines in Tulsa. George Johnson, I think, said it all, and he ;
1 23 did a good job. George and I work together and have for many 24 years. And our -- the end results of what we do is to comply 25 with the rules as written as we understand them. But there was I
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(O LJ 1 mass confusion in the airline industry and other industries as to 2 this associated equipment. Region 4 gave us what they thought to 3 be proper instructicns, and it didn't prove out. We've gone 4
through the trouble and manufacturing equipment to run all these 5
tests as George demonstrated he has the capabilities. We have 6 the capabilities. We documented what we did only to find out 7
that we still have to submit it to the NRC for custom approval.
8 The only thing that I wanted to add to this, and 9 he pretty well defined the cost of all of this, but it's also 10 time. Time is of an essence. If we have a problem on a jet 11 engine, I don't think any of you are willing to fly an airplane 12 for the next three months while the NRC is making a decision to n
13
(] approve or disapprove a custom design.
14 In 1988, we had an engine failure going into 15 Minneapolis. Within eight days, I had a probe, one that had been 16 approved by -- for the airlines. But within eight days, I was 17 able to tell a good engine from a bad engine. Under today's 18 regulations, I would have to violate the regulations to do that 19 because I could not get approval within eight days. First of 20 all, we have to do research and development. I can't do the 21 research and development because I don't have approval. It's a 22 catch-22. Something has to be changed to allow us to do that.
l l 23 I would just like to support that there's no 24 problem working with the ANSI document. I could do that if you 25 would allow the RSO, then, to document what he's done and let it JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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O 1 be approved or reviewed at the next annual review. In the 2 future, Part 34 revision, you're going to insist more and more on 3 a qualified RSO. I have said for 20 years make the RSO '
4 accountable. Make sure the company he represents allows that RSO 5 to be accountable. If he's not accountable, then he's the one 6 you're going to look to. But if you make him accountable, I see 7
no reason at all why we cannot comply with this regulation, )!
8 document what we do, and put it on file.
9 MR. CAMPER: Question for you. !
10 MR. SPEAKER: Yes.
11 MR. CAMPER: The emergency situation that you 12 described, for example, your eight day scenario on an aircraft
, 13 engine, it was an emergency situation. Maintenance and 14 inspection won't address that. The question is, if you're going )
15 to develop a guide tube in this case or whatever piece of guide 16 equipment that it was that you needed, against what criteria or 17 should there be any criteria? Should it be something that you as 18 a professional should do on your own recognizance and that's the 19 end of it or should it be against some standard, and if so, what?
20 MR. SPEAKER: Well, the criteria has to mean will it do 21 the job and do it safely. The guide tube that we're currently --
l 22 that you approved back in January on almost an emergency crisis l
23 is only -- we have a hole through the back end of the engine that 24 350 thousandths in diameter. We have to have the inside diameter
- 25 of the tube approximately 320 thousandths so that the source will O JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 slide through it. So, as you can see, that guide tube had to be 2 centerless ground. Therefore, the wall thickness is so thin, l 3 that it's not going to pass your crush test, but we've been using l 4 that guide tube since 1988 with no difficulty, and other airlines )
5 are doing the same thing.
6 So, the criteria has to mean is it safe to use, 7 and the RSO actually should have the authority to do that.
8 MR. CAMPER: Easy to use. To accomplish a job, to me, 9 is fairly straightforward. I mean, I can follow it. I guess the 10 question is safe, safe by what standard?
11 MR. SPEAKER: Okay. Let's say the end stop has to be i
12 in there. We. don't want to run the source out of the guide tube,
) 13 and the connector has to stay on. But as George fully explained, 14 it doesn't take a whole lot of welding or anything to maintain 15 that. We ran all sorts of tests like George did. It doesn't 16 take much to meet that type of requirement. And what we're 17 trying to do and the ANSI document is a way overkill, but you 18 don't want to ever lose that source outside of containment. It 19 doesn't matter how thin that tube is if you're shooting something )
l 20 straight down it as in the jet engine world. That guide tube is 21 completely enclosed inside of a heavy steel center shaft. So, i i 22 the only damage it's ever going to get is either during the 23 . insertion or somewhere exterior before it's ever installed. I i 24 MR. CAMPER: So, what I think I'm hearing is 11 we were 25 to in a rule making ask for a checklist of items, a minimum JUDICIAL TRANSCRIBERS OF TEXAS, INC, F x (713) 462 3042 . Office (713) 462 6434
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1 checklist of items that would ensure baseline safety, you think [
2 the industry could probably do a pretty good job of giving us 3 those handful of items -- you just went through two of them, in i 4 fact?
5 MR. SPEAKER: I think that the industry could -- you
! 6 know, you'd have to have from the different industries their 7
input, but I see no reason why there could not be a few 8 guidelines established, and if you stayed within those 9 guidelines, you've got no problems. First of all, we found out l 10 that a stainless steel guide tube or material that was M l 1
! 11 thousandths or greater will be absolutely safe as long as it's l 12 not made of soft steel. Anything of the hardened steel 35
- o l
l Q 13 thousandth wall thickness will pass the crush test. We're using 1
i 14 a 60 thousandths guide tube. In that setup that George just 15 showed you a picture of will just bounce off of it and leave a 16 slight dent.
17 So, I think we're working in an area that doesn't j l 1 18 need to be worked. I don't think we have a problem there. The i
l 19 19 years that I've been RSO, it has never been a problem that I l
20 can find in any case histories. I'm not sure where someone 21 decided that it was a problem, but I would sure like to know 22 where all these problems were that would even cause us to have to 23 go this associated equipment. I can see where you're coming from 24 the regulatory. It makes a statement associated equipment.
25 But I also agree with Kate. I think we need to g
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O 1 redefine that word, take it out of there and put something else t
2 in its place, set up some type of a maintenance program that says 3 you shall check it. If you want it checked on a daily basis with i 4 a nogo [sp.ph.] gauge, hey, I can do that. I can do all sorts of i 5
things, but when I need a guide tube today, I need the ability to 6 do so.
7 Yes, Don.
t i
8 MR. NELLIS: I've got a little question here. I can 9 understand where you're coming from. You've been in the business l
10 for a long time. You're obviously a qualified RSO, and the 11 company stands behind you. They're a big company. I don't think 12 they're apt to just -- if something happens, they're just going r
() 13 14 to fire you and so'on, and then we can't -- 'cause we can come back on the American Airlines. But I'm wondering if this would 15 apply to all of the smaller companies, for example. With the l 16 minimum requirements for the RSO, do they have the experience to i
17 do this sort of thing and to put their stamp of approval on it?
18 I mean, that's really, I think, the problem we've 19 got. With the big companies like yours and so on, I don't think l
20 that's an issue. But I mean, somebody gets a radiographer.
21 Eventually, he gets to be an RSO and so on and so on. He has l
22 really minimum qualifications. He may have a lot more than that, 23 but he's probably not got much engineering ability and things and l
24 that sort of thing. Is he going to be able to say, well, all
, 25 right, the company stands involved in what I do and design all b
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O 1 this equipment. I think that's where our -- what our problem is.
2 How do we handle that sort of situation?
3 MR. SPEAKER: Well, I think the lawyers are taking care 4 of that for you. The liability is getting so great out there, 5
that the small company -- if he goes out and he does something 6 major, he's going to be in big trouble. And so, I think a lot of 7 that will handle itself. But you're fixing to come out with a 8
Part 34 change that's going to increase the qualifications of a 9 RSO. And as you do this, I don't see how that it cannot take 10 care of itself.
11 MR. NELLIS: Thank you.
12 MR. CAMPER: Thank you.
13 MS. SPEAKER: Don, just to answer that concern that the 14 small companies do need specialized tools to take away that added i 15 step of regulatory approval. The existing manufacturers can
! 16 probably comply with the customer's need. We would have the 17 expertise. We have the testing apparatus. We have the 18 additional information to make engineering analyses and things 19 like that. So, if a customer called up and needed something 20 quickly, we could then respond to it. We can't respond to it now l
21 because we need the outside approval. We can do it quickly 22 internally. We cannot do it quickly if we need outside approval.
I 23 MR. NELLIS: And you would stand behind it.
. 24 MS. SPEAKER: I'm sorry?
25 MR. NELLIS: And you would stand behind the equipment.
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lO 1 MS. SPEAKER: We would stand behind it. Yes.
2 MR. SPEAKER: I'm Roy Parker. I'm a consultant to 3 numerous radiography companies. And I think that we're missing 4 the big point here, gentlemen. You people seem to be begging the 5 issue that there is a problem and assuming that the regulations 6 can take care of it. I think we're clearly hearing today that :
7
( this is an area where regulations are not necessary. So, why 8 don't we assume the position of, hey, let's get rid of these 1 9 regulations and try to make it work. We've already been saying, 10 hey, look, for many, many years, the associated equipment has not 11 been a problem. So, let's don't overly regulate it. Let's don't 12 cause the expense. You people have not demonstrated the need for 13 it, so let's just get out of it. Cut your losses.
14 (Clapping) 15 MS. TROTTIER: Is there anybody else? l 16 MR. SPEAKER: I'm Robert Baker. I'm the RSO at 17 Transworld Airlines. I think what you're seeing is we have no 18 problems with the projectors. The flexible guide tubes, the j 19 tubes that are built by the manufacturers. What we run into is 20 custom problems. .Now, you're saying how can a small outfit do 21 this. Okay. Let's take a small company. If you have that doubt 22 they can build up a few, you can test them. Have an independent 23 tester do it if they know how to do it. You are willing to 24 accept a known tube that has been worked, used as a tube that can 25 be continued in use with proper certification. Why can't we i
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w, 1 prove it if that's what you want?
2 second, we set up a program of inspection before 1
3 We run a we go into the job, inspection as we insert on the job.
1 4 dummy down through the tube. This can be done any time. It's no l
5 problem. So, I just -- I don't see the reasoning. What we need l 6 is the ability -- we have the equipment to do it -- to build that 7 emergency tube or that guide tube that the manufacturer can't l l
8 give us. They can't stock 50,000 different tubes for the entire '
9 industry. And I think that's all we're asking for in this 10 situation. I'll keep it short. That's all I needed to say.
11 Thank you.
12 MS. TROTTIER: Thank you. Go ahead.
(j 13 MR. SPEAKER: Tim Hart with the United States Navy. I 14 have a couple of questions or comments, I guess. The first one 15 would be after January 10th, we had some equipment personnel 16 procedure problems at one of our particular gamma radiography 17 commands. We took the device in question, shipped it back to the 18 manufacturer. The manufacturer did an evaluation and said 19 nothing wrong with the equipment. Sent the equipment back to the 20 ccmmand, and they used that same piece of equipment. And less 21 than 45 days later, we had a repeat problem.
22 The second time, the Navy said, well, you know, we 23 do have to send it back for Part 21 evaluation, but I think we're 24 going to be a little smarter this time. We're going to go and 25 send an independent team down and look at it. Our investigation
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1 was -- I don't want to say inconclusive, but it had three facets.
2 We saw that there was a potential equipment problem. We saw i 3 there was a potential unfamiliarity with the equipment, and we 4
saw there was some procedural shortcomings. And so, we took on 5 all three. We took on to address all three. l 6 My question would be -- rather, I have -- rathed-7 it be an exposure device, a drive cable, a guide tube, a source
- 8 stop, if I have an equipment problem, an equipment failure and I 9 take that piece of equipment and send it back to the manufacturer 10 to do the Part 21 evaluation, would you as the manufacturer find 11 anything wrong with that equipment? The company in question, I
'12 have the utmost respect for because we've used their equipment y) 13 for years and it's excellent equipment; however, it just doesn't 14 make good monetary sense.
15 Going one step further in talking with Jim, 16 probably a more logical safety evaluation for a problem part 17 would be to let people take and manufacture the pieces that they 1
18 need to use given some basic guidelines, and if they have a 19 problem, have an independent entity do the review of the 20 equipment, not the manufacturer, not the user; maybe the NRC, but 21 certainly someone independent of its use. Take -- look at the 22 equipment and say whether or not you've got a problem as opposed 23 to every -- I've got 2,000 different designs of "J" tubes and 24 source stops. If you guys can do the evaluations on those, why 25 doesn't the NRC do the Part 21 evaluations on a failed device and JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 do we really want you to? This -- I think that about covers it.
2 MR. CAMPER: Help me out. I think I missed the 3 question.
4 (Laughter) 5 MR. SPEAKER: I guess it's not so much a question as it
.6 is a comment. You're going to tell the company I as a gamma ,
7 radiographer, you're going to tell me that I think my equipment -
8 - and let's think about this. I'm a radiographer, and what do I 9 do for a living? I radiograph planes, right, radiograph pipes l
10 and nuclear power plants. Oh, my god. If I can't inspect and 11 design equipment that I can use to do this, how is it that I can 12 stop the planes from falling out of the sky? i've got a q
l Q 13 contradiction in terms.
l 14 We have -- when the Navy sees a problem with the 15 equipment, I don't see that sending it back to the manufacturer 16 to do the Part 21 evaluation is correct stance. I wouldn't say 17 that maybe each radiography company has got the technical 18 expertise to do the evaluation themselves, but let's put in the 19 regulations something -- let's not do a whole bunch of research 20 on a piece of equipment before it's failed. If we have a big 21 failure problem, and we've heard that the "J" tubes and the 22 source stops are not a big failure problem, why regulate them?
23 MR. CAMPER: I thought there for a moment you were ,
24 headed towards the self-certify approach. But what I think the 25 last-part of your comment really says just use it until there is
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i O 1 shown a failure and then evaluate the failure, and don't worry 2 about it unless you have a failure.
t 3 MR. SPEAKER: Basically, except for I would ask the NRC 4 to lay out some basic minimal guidelines as to what it has to l
l 5 meet, i.e, you've got to have a certain I.D.; you've got to have 6 a certain -- you've got to have a stop on the end; you've got to 7 -have a certain compatibility of threading. Okay. ,
8 MR. CAMPER: That gets back to that minimal --
9 MR. SPEAKER: That's right.
l 10 MR. CAMPER: -- minimal checklist concept that we could 11 explore.
12 MR. SPEAKER: And if you want to do -- if you want the ,
l f'-
13 community to do independent certification, i.e., I create a guide l
14 tube or a "J" tube or whatever, I create it and use it. If you 15 feel it's important enough for someone to do an evaluation, then 16 tell us. Okay. Do an evaluation, whether it's a design 17 evaluation, whether it's physical testing, or whether it's some l 18 good sound engineering evaluation. But don't -- I have a rough 19 time figuring out how come the NRC can't do Part 21 20 investigations, but can do certification of equipment -- of j l- j 21 auxiliary equipment. That's all.
22 MR. SPEAKER: Dave Culbertson with Tenneco Energy, RSO.
23 I have a NRC license, and I think we're down to maybe five 24 Agreement State licenses. For our particular business, we've 25 downsized a little bit. So, we've got a lot of surplus
.0 v
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1Q l 1 equipment. And when this new requirement came in, we tried to 2 meet it in accordance with the recommended guidelines that came l 3 out documenting, you know, the purchase of this and try to go
! 4 back through the paper trail. It's a nightmare for a large 5 company to try to find the appropriate purchase order 6 requirements. Now, I don't know for this particular camera what 7 really the associated equipment that came with it when we
[ 8 originally purchased it. So , it's become a nightmare to try to l 9 chase that down and come up with some good documentations.
l 10 The other problem we're having is the fact of the 11 collimators. I think John alluded to that with Capital X-Ray in 12 Tulsa, their particular problem. We've got a lot of specialty 13 collimators that we purchased over the years, and now, we can't 14 utilize those. They don't fit into the particular requirements 1 1 !
15 under the new regulations. And we're also being mandated in some 16 of our Agreement States that we must use collimators. So, that's 17 required us now to go out and purchase new equipment because we l
- 18 can't document the old equipment as meeting the particular 19 requirements. So, that's placed a burden on our particular 20 industry and an additional cost.
21 Now, what I'm hearing in the concept today and I 22 have to somewhat agree to it, if it fell back on the licensee and 23 we're given some guidance as to some checkpoints as a minimum, 24 and that these be reviewed or audited as necessary to see that cauS -
25 the industry is complying with that, I think you put the .owness--
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O 1 [sp.ph.] back where it needs to be and that's on the user. If 2 the user has a particular problem, a disconnect or some 3 associated problem because of that equipment, then it falls back 4 on them. They're responsible for maintaining, making sure that 5 it meets those particular maintenance components.
6 So, I agree that we ought to back off on this 7 particular regulation and put it back on the licensees.
l 8 (Pause) 9 MR. CAMPER: I certainly hope you bring that up in 10 peace.
11 (Laughter) 12 MR. SPEAKER: My name is Donny DiCharry. I'm with i 13 Source Production & Equipment Company. And I have a few comments 14 and then a few recommendations. I know you have asked us to be 15 brief so I've limited my comments to about 20 pages of notes 16 here, but they're small.
I 17 First of all, I'd like to thank the NRC for having 18 this workshop. I think that after the Vancouver workshop last 19 May, it became apparent that some of the problems associated with 20 the associated equipment portion of the rule really are a problem l
21 and really do need to be addressed and are not going to be 22 addressed fully by virtue of the NRC's Information Notice 96-20, 23 and I look forward to some good response and solutions that will 24 come out of this workshop. I'd like to state from the outset 25 that SPEC is fully in support of Amersham's petition. I have one V
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! l reservation and it is that Amersham stole our thunder. We wanted j 2 to d 'o the same thing. They - we have opposed the labeling and 3 the whole system registration concept with the NRC since 1991.
4 And so, I'm pleased that the petition was sent in and that it's 5 now before us.
6 In my opinion, the registration of all systems 7 with all combinations of associated equipment.has a number of 8 . problems associated with it. It's impractical simply from a l
l l 9 licensing standpoint. A system consists of, as a minimum, a 1
10 camera, a source, a set -- a control assembly, and a guide tube, !
l l 11 perhaps, even a collimator. Well, you don't have to be much of a 12 mathematician to figure out that mathematically, we can end up
. 13 with literally thousands of combinations of systems that all 14 might have to be registered in some form or another if the rule
- 15 is maintained. That also would be very expensive primarily to 16 whichever entity must submit to these applications to register 1
- 17 each system.
18 But the point that is perhaps most relevant is l
19 simply that it does not appear to be significant to safety, and I 20 believe that that is the point that Dr. Parker made, and I do 21 agree with it. That also was a primary comment that was echoed j 22 at the Vancouver workshop. There are some very difficult 23 problems that are imposed upon the users if every system must be 24 identified and registered. And it does free trade, if you will.
25 It doesn't prohibit. It limits. It puts a chill on competition l JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 and the ability of the users to pick and choose among the various 2 manufacturers to get to the level of quality at the lowest 3 possible price that they can get in the marketplace.
4 And I have one question about -- which I don't 5 know that I-can get an answer from now, but one question about 6 what is the regulatory link between creating a rule that 7 specifies the minimum requirements of equipment and automatically )
8- resulting in an interpretation that all equipment combinations 1
9 must be registered. We agree with the ANSI standard. We think 10 that it is useful and good, and I have not really explored this, 11 but I just am not certain that there is automatically a link to 12 require everything to be registered. And I think that is what is
( 13 really the big problem to the users. It's this registration of 14 it all.
15 There have already been some possible solutions 16 that have already discussed and have already been put on the 17 table, such as the ability of a user to file for an exemption. l 18 And yet, we've already seen that there are significant problems 19 with this approach. Number one, it does -- it is expensive, and 20 number two, it does take time, and in many cases, the time is 21 simply not available. George Johnson pointed out that when he 22 asked us to provide a rigid guide tube for him, it took two l 23 months for us to get the necessary approvals. We have speeded up 24 the process. It only took five or six weeks for us to get 25 approval for guide tube that can be used in sub-freezing weather.
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,b 1O 1 And so, that just simply is not a very practical approach for the 2 industry to take.
l 3 The approaches that were offered in Information 4 Notice 96-20 also have problems associated with it. One of the 5 options is that users could rely upon manufacturers' checklists 6 to be able to visually or in some other way take a look at the
! 7 equipment, and based upon the checklist, to be able to determine 8 whether or not the piece of equipment does comply with the ANSI 9 standard. And especially old equipment that you purchased a few 10 years ago before the new rules went into effect that are 11 perfectly usable, and most prcbably do meet all the ANSI 12 requirements, but you do need a way to be able to prove that the I
n 13
' 't.j equipment does meet the requirements. j 14 And I would -- as we pointed out in Vancouver, the 15 use of a checklist is not a very reliable means to verify that a l 16 piece of equipment meets all the requirements. There are too l
17 many components that are simply -- they look too much alike. The 18 fittings that we put on a control assembly today look a whole lot l 19 like the ones we put on control assemblies 20 years ago. And did 20 we test equipment 20 years ago to verify that it meets the ANSI 21 standard? No, not at all. And so, there can be errors made in 22 relying upon a manufacturer's checklist.
23 Certainly not intentional, but one of the l
24 consequences can be that this does impose an additional level of 25 liability on the employer of the worker who is hurt using a piece v'
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l 1 of equipment that later during litigation, it is shown that the l
2-piece of equipment was, if you will, approved by the employer 3 using the manufacturer's checklist, and it turns out that the 4
piece of equipment never was really tested and approved to meet 5
the ANSI standard. So, now, there is a serious question of l
l 6 liability.
7 The option'in Information Notice 96-20 to use an 8
engineering analysis, we disagree with quite strongly, and the 9 main reason is because there is no regulatory definition for this 10 term " engineering analysis". I feel that the responsible 11 radiography companies are perfectly capable of doing an analysis 12 that will allow them to conclude whether or not their unmarked 13 piece of equipment is safe for use and does seem to comply with a l
14 design that has been tested and marked and shown to meet the ANSI 15 standard.
l 16 We also know that there's another side of the coin 17 and it is that there are some radiography companies that would-
! 18 rely upon this undefined engineering analysis to perform a smoke 19 and mirrors magic wand approach to verifying that their equipment 20 meets the requirements. And testing labs, undoubtedly, would be l
l 21 tempted to do that without realizing that once again, they also 22 invite a significant amount of liability if that equipment is 23 involved in some sort of an overexposure event which is 24 inevitable.
25 The -- and so, the self-certification approach has JUDICI AL TRANSCRIBERS OF TEXAS, INC.
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O) 1 some significant problems to the radiography companies 2 themselves. It also invites many compliance problems that we 3 haven't even begun to discuss here, and it is that if a company r 4 -certifies their own equipment, they develop their own ANSI test 5 fixtures like Capital X-Ray has done, now, how does the 6 government verify that their ANSI testing equipment complies, and 7 who comes to audit them to see whether or not they performed 8 ;
their ANSI testing in accordance with the ANSI requirements. And
(
9 so, it just goes on and on, and -- which would be important to :
l 10 try to pursue if there were ample evidence that the associated a 11 equipment part of the rule really is significant to safety, which 12 it just simply does not appear to be.
O V 13 So, I do have some -- a few recommendations, and -
14 the first one in keeping with Amersham's petition is to simply l
l 15 eliminate the system rule from 34.20 as it applies to users. I r
16 would also recommend that the ANSI standard not be scuttled. We l )i 17 do believe in these requiremer.ts for the manufacturers to test )
i 18 their entire system, but to relocate that requirement to Part 19 32.210. Maintain the requirement on us manufacturers, and that's 20 where the responsibility is now, and that's where it should 21 belong as opposed to imposing it on the users. I 22 I would recommend as a third item that the NRC !
l 23 clarify that users are able to mix and match components of l
l 24 various radiography systems without having to register another f
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1 adopted. And it goes beyond simply being able to take one 2 manufacturer's set of controls and use it with another ;
3 manufacturer's camera because it gets very significant from a 4 financial standpoint to the users of whether or not the users are 5
able to take their set of controls, and when a single component 6 breaks, to be able to use a replacement component from another 7
manufacturer, to be able to take the drive cable out of your !
8 control assembly and replace it with another drive cable that is 9 made by another manufacturer.
10 The industry has successfully done this for 40 11 years. To reiterate, we prefer for the system testing I
12 requirement to be imposed on the manufacturer, but just like with 13 the automobile industry. Manufacturers are required to comply 14 with certain requirements for their automobiles, but then when 15 they send it out to the consumer, the consumer is allowed to 16 decide which brand of tires it wants to put on the car. Now, 17 certainly, it's arguable that tires are very important to the 18 safety of a vehicle, and yet, if the automobile consumers can 19 safely choose which tires they want to use, I would submit that 20 the radiography industry is able to do the same.
21 Another recommendation also in keeping with 22 imposing the ANSI standard requirements on manufacturers in Part 23 32 as opposed to Part 34 is to clarify the QA program 24 requirements that are required of manufacturers. And I would 25 recommend that regulatory guide 6.9 would be the model that JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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(3 1 should be used by manufacturers or equivalent. The most 2 important aspect of this as far as being able to identify and l
3 correct generic safety problems is that these QA programs do l
4 require that manufacturers maintain records of equipment
]
5 failures, of customer complaints about the equipment, and it does
~
6 require that we take corrective action.
7 Even if the equipment complies with the regulatory ) i 8 requirements, we still must address indications of safety 9 problems. Amersham does that. SPEC does that. All 10 manufacturers should do that. I would also point out that the :
1 11 ANSI standard can continue to require increased levels of 1 i )
12 performance on radiography equipment, and the result will be that 13 equipment will become more reliable, and it may also last longer.
14 Yet, just like the equipment that was manufactured 20 years ago, 15 all the equipment will eventually fail. It will wear out. It 16 will be subject to damage. And so, the ANSI equipment is not a 17 solution to equipment malfunctions.
18 And now, we are getting further emphasis on the 19 second part of Amersham's petition, and it is to clarify and 20 enhance the inspection and maintenance requirements that should 21 be used by the licensed -- by the users of the equipment. The 22 manufacturers are the ones that are in the best position to know 23 what sort of inspection should take place, what sort of l'
24 maintenance should be done, and particularly, what the frequency 25 of the maintenance should be. Manufacturers should be required
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l 1 to give a maintenance schedule under normal use conditions and 2 abnormal use conditions.
3 Currently, there is no requirement for users to 4 comply with any manufacturer's recommendation of inspection and 5 maintenance of their equipment. I also would like to point out 6 and recommend that some systems should still be registered, but 7 not the sort of systems that we have identified fully in the ANSI 8 standard.
9 There are some combinations of equipment that 10 there should be some control over so that the user knows that the 11 system is compatible, but there are only four items that really 12 are significant to safety. The first is the camera, the second im
) 13 is the source, the third is the drive cable connector, and the 14 fourth is the control adapter, the item that connects the control 15 assembly to the camera itself. These are the four items that 16 really comprise the portions of the operating system that all 17 needs to fit together, all needs to operate together. And I 18 would think that there would be a way in which those combinations 19 of items could be registered, could be easily reflected in 20 guidance to the users so that the users always know whether or 21 not they have this newly defined system that is all compatible 22 with each other.
23 And that's my last page. So, I appear to be l
f 24 finished.
25 MS. TROTTIER: What I'd like to suggest is that we take
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1 a lunch break now, which is -- this is about the time I told the 2 dining room to expect us. And in case there are people who do 3
want to go off site, I'm going to suggest -- it's quarter of 4
twelve; let's come back here by 1:00. That gives you a little I
5 extra time if you are driving somewhere.
6 (Recess) 7 l
AFTER RECESS 0
MS. TROTTIER: Okay. Shall we get started for the I 9
afternoon session.
10 l (Pause) 11 MS. TROTTIER: I wanted to make a couple of reminders l 12 before we get started. One is a lot of you have given me cards.
O t 13 So, don't forget that if you want to get a copy of the 14 transcript, please let me know today.
15 I also wanted to make mention of the fact that we 16 discussed the petition and it was out for comment, but I don't 17 remember whether we indicated that the comment period doesn't I l
18 close until early September. So, if when you get back, you 19 think, wow, I wish I had said this, I mean, I think this would l l
20 have been a really good idea to convey and you didn't do it, 21 you're certainly welcome to send in a comment letter. The 22 Federal Register citation which I probably didn't bring --
23 MR. NELLIS: September 3rd. l
, 24 MS. TROTTIER: Is it September 3rd?
25 MR.' NELLIS: Kate, I thought you were going to apply JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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2 MS. SPEAKER: I will apply for an extension. Yes.
3 MS. TROTTIER: You will? Why? You want to comment?
, 4 (Laughter) l l 5 MS. TROTTIER: It's always best when you are commenting j l 6 officially to use the official address. If for instance you send 7 it to us, we will forward it to our secretary, but it's best to 1
8 follow the directions that are in there. And since I can't find 9 the notice in front of my face, I will just -- okay. Larry is 10 going to give it to me. So, you know, that way, you know exactly j 11 what to do.
12 Submit comments to the Secretary of the USNRC, )
l (3 13
() Washington D.C. 20555-0001. We wouldn't want to not use that.
14 Attention Docketing and Services Branch. That way, it gets 15 docketed right away. I mean, it's not a big problem. If it 16 comes to us, we forward it to docketing, but it just saves one l
17 extra step in the process. So.-- and we are going to try to move 18 on this rule making initiative, which means sometimes when we 19 have petitions out for comment, many years go by before we 20 resolve them, not that this is a good thing, but that happens, in 21 which case it doesn't matter how long it is before you send in 22 comments.
j 23 What I am going to say on this one is if we do 24 extend the comment period, which I don't see that we can't agree 25 to that, we probably won't extend it for more than 30 days. My 7s JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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lG 1 goal is -- and I have talked to the state of Texas about this 2 earlier -- is to move forward with this, at least to the point of 3 getting a rule making plan out to the Agreement States for review 4 by December. So, what that means is by October, we've got to 5 have our thoughts formulated and start putting something 6 together. So, if you are going to provide comments on the 7 petition, try to do so before the end of October because it's 8 going to be more useful the more timely they are. If we get too 9 far down the process, we just won't be able to consider 10 additional comments.
11 Now, you know, this is not really impacting 12 anything other than potential development of a proposed rule.
< b) 13 You know, once a proposed rule gets out, well, certainly, there's 14 not a comment period, but this is just a comment on the petition 15 that was submitted and any ideas that you have on things that i 16 you'd like to see changed in 34.20.
17 So, with that, I think I'll just open the floor 18 back up again to comments. Donny, did you --
l 19 MR. SPEAKER: I just wanted to ask for verification.
20 The comments that we are submitting here today verbally are 21 considered comments on the petition?
22 MS. TROTTIER: Yes. Because -- and that's a good 23 question. Because we're having this transcribed, while we 24 provide you the information in a transcript, our primary purpose 25 in having it transcribed is so that we can use this information.
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v 1 So, if you've already said something here today, you need not 2 send that in in writing. I'm just saying if there's something l
3 that when you get back and home, oh, why didn't I think of that l
1 l 4 or if someone else says, boy, I wish I could have been there to 5 provide this, there is still an opportunity, although it's 6 relatively short, you know, but at least within the next month or l
l 7 two.
L l 8 okay. At that, then, I'll shut up again and let ,
I 9 you speak. Go ahead.
10 MR. SPEAKER: My name is John Forbis. I'm from l
l 11 Reinhart & Associates in Austin, Texas. We're a small company.
12 Do a lot of radiographic work, a lot of different projects on a !
.m l
13 small basis. I'm kind of the devil's advocate here. I'm a very 14 young RSO, very little experience. And I still visualize things
! 15 as a radiographer. I still think about the jobs that I have done 16 and the ones I will do as a radiographer more than as a RSO. .
17 And it comes to my mind that no matter what 18 requirements are in place as far as certifying well devices or 19 attachment devices and so on, that the radiographer is the last 20' point of control for whatever happens. In Texas, in a traffic 21 accident, the person who can last stop the accident has got some l 22 liability than anybody else. That's kind of a common sense 23 thing. And radiographers are not engineers, not necessarily 24 mechanics. I know I don't trust mine with a whole lot of 25 mechanic work. However, as we have heard for the last few days, JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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O 1 they're trained and certified and required to be carded soon to 2
be by NRC and certainly by Texas already. So, they have some 3
degree of responsibility and accountability built into the 4
certification. i 5
One of those things as people have pointed out is 6
the duly equipment checks and, of course, the RSO iu responsible 7
for the q- terlies. But it's the radiographer that will be 8 checking h. equipment out everyday before he uses it and right 9 on the spot. Perhaps, he's had a helper drop something and it 10 needs a second look, not just at the first part of the day.
11 Now, radiographers have good' days and bad days.
12 Okay. They have good jobs and better jobs. Aircraft work is 13 nice if you can get it. A lot of times we're climbing tanks or 14 climbing into holes or going through places where people most $
l 15 normally don't go. And certainly, not with delicate equipment or l 16 equipment that could be easily damaged, but, of course, we're not 17 talking about things that can be damaged and can really cause 18 problems if they are. The man in charge is in charge right 19 there. He's goc to know, well, that source tube has got a little 20 bit too tight of a radius on it; I better straighten it out and 21 so on.
22 Of course, all of us have gotten over unlocking l 23
,ur self-locking cameras and climbing back out through the manway 1
24 and having it click behind us and then crawling back in and 25 unlocking it again, and then crawl out and try not to touch ,
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I 1 anything. That was a problem of leaving a little pressure on the i 2 crank handle in the forward direction. I believe everybody knows 3 that now.
4 Anyway, like I say, it's the man in charge on the 5 job that really has control of this no matter what. No source 6
tube is going to survive a tumble down a hopper in a boiler or in 7 a vestibule or a drop from a water tank. I'm not even going to 8
tell you about water tanks. Anyway, that's the point. You've 9 got a man in charge already. The equipment that's been out there 10 for so long has really not given us a problem in that way. And 11 all the new features in the new locking cameras and the new 12 attachments on the pigtails are so good that we're confident in 13 those new improvements.
14 Another think I'd like to address is while this is 15 going on, Texas licensees are actually being almost written up.
16 Let's say given their first warning that their source tubes 17 aren't labeled, they don't have PO's for all their old stuff to 18 show where they bought it. I don't know if it's true. I hea: d l 19 it. Someone was asked why he shouldn't stack up all his source 20 tubes and " crank-outs" and survey them just to make sure that 21 they're not contaminated. This is pretty scary to me.
22 We're a small company. Someone came in and told 23 us that we should have a PO for everything we had laying around 24 that we use on a daily basis or could use.
l I don't know. Not 25 too scary absut the cameras or anything. Any sort of controlled !
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1 material, we would, perhaps, be tempted to throw the saddle out 2 the window and let the shack burn down as my old grandpa used to 3 say. Thank you.
4 MR. CAMPER: Let me make sure I got that. Throw the 5 saddle out the window and let the shack burn down.
6 (Laughter) 7 MS. TROTTIER: Go ahead.
8 MR. SPEAKER: Of course, if you're north of Waco, you 9 don't know what that is. ;
10 (Laughter) 11 MR. SPEAKER: My name is Earl Banfield. I'm the l 12 corporate radiation safety officer for MQS Inspection. We're an ;
( 13 Nonagreement and Agreement State licensee in several locations l 14 throughout the U.S. And I'd like to just possibly put this into 1
15 a little prospective here. Mr. Camper had mentioned that three l 16 to five percent of the licensees are industrial radiography 17 licensees, yet, they represent 30 percent of the overexposures.
18 Could I get an idea about how many overexposures we're talking 19 about here? Two, maybe three a year?
20 MR. CAMPER: I don't recall the exact number. What I !
21 said was at that point in time, back in the eighties, they
, 1 l 22 represented that percentage of the licensees and that percentage 23 of overexposures at that point in time. I don't know what the
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< (g 1 MS. TROTTIER: Actually, it isn't very many, at least 2 now with the most recent set of data, which is the data from -- I 3 think we have published '94 data. We're about ready to publish 4 '95 data. Now, I will say in fairness to radiographers that we 5 only get data from a subset of our licensees. So -- but, of 6 course, those are the licensees that we expect to handle the 7 larger amounts of radioactive material, which is why we set them 8 aside as ones who have to report to us.
9 But we did look at this when we were drafting the
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10 final rule that went to the Commission because the state of Texas i
11 had raised this as an issue of why we should adopt the two man 12 rule because it did reduce the number of exposures in their i 13 jurisdiction. So, we did look at it for our licensees. And we 14 did notice that there are overexposures from radiographers, but I 15 don't remember the numbers as being more than a handful. I'm 16 saying less than ten, I think, for the year.
17 MR. SPEAKER: And also, would it be accurate to say 18 that none of these exposures were lethal exposures?
19 MR. NELLIS: I just wanted to add a little bit here.
20 You know, when this all came into being, it was back in the 21 sixties when our first records on radiography problems came l 22 aboard, and I have a whole chronology of things. And there were 23 an awful lot of then. Of course, some of that radiography, I 24 think, is what they call fishtail radiography, and people weren't 1 i
25 trained very well and so on. And there were a lot -- it was
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lO 1 difficult to get good records. Now, Texas had a lot of records, 2 and at one time, we had a number of them, but they were printed l
3 out on -- and Texas didn't have a large staff. They would print 4 out what happened and who got exposed and so on, but they didn't !
5 give all the details as to why. So, we didn't really know.
l But 6 there were a tremendous number of them, and some of them are 7 pretty hefty.
I 8 over the years, things have gone down and they've l 9 gotten much, much better, and we only have a few per year. But I l 10 do know of two last year. I can't remember where they were. One I 11 was kind of silly. It was -- for some reason or other, two 12 radiographers were working up high on a scaffold and they had 13 this source up there and they were putting things up. They never 14 retracted the source, and one of them, I recall, got something 15 like 1500 MR to his head, and the other one was somewhere in the 16 order of 900. And so, that's -- and these are supposed to be 17 radiographers who knew what they were doing. So, at least that's 18 just plain sloppiness.
19 MR. SPEAKER: Excuse me. Can I butt in on that one?
20' Let me throw this one in. That was a prime example of an 21 alarming rate meter, the radiographer relying on it, and up where-22 he was, he relied on his alarming rate meter. It didn't work 23 because of the noise and other things. So, in this case, I want l
24 to bring that out as a contradictory point to the alarming rate l
25 meter question. Thank you.
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,O 1 MR. NELLIS: He was still violating the rules, though. l 2 MR. SPEAKER: In what way?
3 MR. NELLIS: He was supposed to retract the source --
4 MR. SPEAKER: Oh, definitely. He was supposed to 5 retract it, but he did do what he thought was a survey.
6 MR. SPEAKER: So, therefore, the point I'm getting to )
7 is that the number of overexposures that have occurred in 8 industrial radiography by number is only a handful. One. Two, 9 that of those handful of exposures, very few if any of those were 10 related to equipment problems, and even more so, those that were 11 related to associated equipment only.
12 So, looking at this in a risk management sense, i
13 you know, I'm looking for a cost benefit ratio here. Industry 14 has spent a lot of money to comply with this. Mr. Johnson has 15 mentioned that he spent $92,000, and also was not included in the
]
16 value he gave you was the administrative costs or the hidden 17 costs on top of that. Those are even tougher to quantify, but 18 they are a substantial expense. So , therefore, the associated 19 equipment component of 34.20 has not resulted in a reduction or 20 at least a significant reduction of exposures, and the cost of 21 compliance has been substantial.
22 Looking at a risk benefit ratio here, it does not 23 appear that this regula+ ion has any benefit for the amount of 24 money that's been spent for compliance. Now, we take -- so, l 25 therefore, why do we have this regulation, not to mention t, hat
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107. i O 1 also, the industrial radiography industry has improved 2 substantially over those years regardless of that regulation.
3 I also want to mention that for licensees to 4 verify compliance is difficult a t beat. You look at a guide f l 5 tube. It's a fairly simple component. Take a look at a drive ,
6 assembly, a drive assembly that has been certified by a ,
7 manufacturer. Not every single piece on that drive assembly has 8 been marked by the manufacturer, and it is impossible for the j 9 licensee to verify that each component comes from the original 10 manufacturer. A technician or a RSO replaces the screws in the 11 cap on the drive assembly. We have no way of knowing. But since 12 he did replace those screws, that assembly is not longer 13 compliant. It was not manufactured by the manufacturer.
14 Does it have an impact on safety? Replacing those 15 screws doesn't have an impact on safety. It's more of an impact 16 that they're in there at all. But anyhow, thank you.
17 MR. CAMPER: Yeah, I don't have the reference I was i
18 quoting from this morning. I don't have it here with me. It 19 must be in the room. But the point was the numbers, I don't 20 recall what they were, but they were small. What I.was pointing
- 21 out was that one of i le things that was causing concern was the 22 relationship, the fact that three-and-a-half percent were having 23 25 or so of the overexposures, albeit the number was probably 24 small. But it was the relationship that was causing concern back 25 in the eighties.
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O 1 MR. SPEAKER: My name is Daniel Bonvillain. I'm an RSO 2 with Capitol Ultrasonic in Baton Rouge. I'd like to just give a 3 . comment about what all is being said. As my company -- as the.
- l. ,
4 gentlemen from Oklahoma with the large company, I have a small i
5 company about 50 employees, and it's been very cost burdensome to 6 me to -- I don't set compliance as a goal, but rather the 7- standard that I operate my business by and try to comply with 8
l what I read the rule to say has been very costly to me. And 9 weighing the benefit of that cost versus safety, if the equipment 10 that I have has been working safely and has a long track record i
11 of working safely, why impose this burden of proving all this to ;
12 this standard on me when more or less as Dr. Parker said earlier, !
13 if I don't have a problem, why make me fix it? :
14 And to quote what was said by the panel earlier 15 that, quote, the feeling of a task force was that this would be 16 beneficial. And I'm an American citizen and a ' taxpayer, and I 17 help pay the salaries of those regulatory people who sat on that 18 task force that had a feeling. But that feeling -- you know, I 19 have a better feeling that this equipment that I use has ' een 20 working safely for years, and by spending money to certify it or 21 replace it is not making it any safer than it's been for the last 22 20 years.
l 23 MR. CAMPER: Let me take this as an opportunity to try 24 to answer a point I think I heard in your comment real quickly-25 and also that Donny made earlier, and that is if I go back and I i
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1 ("h l U 1 look at this now as someone who wasn't in the loop at the time, j 2 someone who took over this particular program area a year-and-a- l 3 half ago, but someone who's looked at this closely since that 4
time, a couple of observations that I'm struck and I thought I --
1 5 we'll take a minute just -- how did we get here? Why is it that !
1 6 we have what we have today?
1 7 Well, I think if you go back, the root of it is 8
that in the ANSI standard of 1980, which one can argue that it )
9 was perhaps interpreted incorrectly -- you can certainly make 10 that argument. I would hear that; I've heard that. If one goes )
11 back and looks at the standard, though, you find something called 12 a gamma radiography system. And it says, I quote, all components l
,. 1
( 13 necessary to make radiographic exposures, including the exposure 14 device, source assembly, control, and other components associated 15 with positioning the source, such as source guide tube, exposure I 16 head, and collimators if used. Okay.
17 So, I think that was the basis by which associated 18 equipment became captured in the process. We subsequently 19 embraced the ANSI standard in our regulations. One can argue 20 that, perhaps, that was a misapplication of that standard. I can 21 understand why you would make the argument. The idea at the time 22 was that there would be some minimum set of criteria that would 1
l 23 be put in place for equipment standards. That happens to be the l l
24 criteria that was chosen. I mean, there are pros and cons to i l
25 using industry standards. I do think it's a reasonable posture l O JUDICIAL TRANSCRIBERS OF TEXAS, INC. j Fax (713) 462 3042 . Office (713) 462 6434 i
110. .
1 for regulators to take to try to embrace industry standards 2 whenever possible because of the consensus that you typically get 3 from that of the buy in. I mentioned this in one of my talks 4 previously.
5 So, anyway, I think that's what it going. Then ?
6 you take a look at, well, how did it end up getting into the 7 sealed source device review process. If you look in 30.32 of our ;
8 regulations -- Part 30 is an administrative part of our l
9 regulations that applies to many parts, and then there are 10 specific parta. In the case of radiography, it's Part 34. In the l
11 case of medical, it's Part 35. The radiators Part 36, etcetera, 12 etcetera. But you'll see something in there that says the 13 following:
l 14 Application for specific licenses. States under 15 paragraph "G" that the applicant, parenthetical licensee, is 16 required to identify the source or device as registered by 17 the Commission or an Agreement State or submit the 18 information identified in 32.210(c). In many cases for l
19- efficiency and convenience, the manufacturer, not the 20 licensee requesting use of the device submits the 21 information to register the equipment. This is an 22 acceptable practice as covered in 532.210.
23 So, what happened was, we looked at the embodiment )
24 of the components, the associated components as defined in the 25 ANSI standard, as embraced in our regulations and codified in our :
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/m V) 1 regulations. And then that transcended into virtue of this by i 2 via this requirement into sealed source and device review. Now, 3
it seems to me as we progress over time, we now find ourselves up !
l 4
against a deadline that has been hanging over us for some time.
5 Along the way, for whatever reason, there seems to have been 6
either a lack of awareness, perhaps some misunderstanding, some l
7 thoughts that it would ultimately go away, any number of reasons 8
why the January 10th date wasn't an impending date of terrible 9 importance.
10 But then it came to be, and now it's after the 11 fact. And then you have these problems that have surface as it 12 relates to associated equipment. This is what gets me back. I
,m i
) 13 mean, that's sort of a 45 second overview of how it is I think we 14 got where we are today. And of course, what we're searching for 15 now is, you know, what should we do about it, and we're getting a 16 lot of good input and opinions. But I thought I would just take 17 just a minute to explain how I think in the executive executive 18 summary how we got where we are.
19 MR. SPEAKER: Since Dr. Parker brought it up about the 20 alarming rate meters, I'm sure the NRC has in their documentation 21 up there where we wrote them letters telling that we had found 22 out, and pil of us RSOs and all of us smart people, none of us 23 realized that that rate meter battery could be checked with a 24 battery check, but that rate meter wouldn't read radiation, 2,5 wouldn't work. We found it by accident. We found out by i, ,\
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lO 1 accident in NRC state, by the way. We found out if we change the 2 battery, hey, now all of sudden it will read radiation.
3 We wrote the state of Texas at the same time, told 4
them that since we found out these rate meters may not work, the 5
only way to know the rate meter works is to put it in a 500 MR 6 range. And the only way to put it in a 500 MR range when you're l- 7 operating with 30 curies is to get it up in front of the camera, I 8
l and now you're making an extra exposure to check your rate meter 9 that according to all principles, you shouldn't be making. The 10 state of Texas wrote me back and said you can't do that. I wrote 11 them back and said, well, we're going to have to do it anyway 12 because that's the only way we know how to check the alarming i 13 rate meters.
l 14 So, we've got rate meters out there that everybody ,
1 L 15 is depending on, and that's probably what happened when the boys l 16 got the overexposure there. They didn't want to use their meter.
l ,
17 Doctor, you're not going to get radiated without the meter no 18 matter what you do if it's working -- if it's working. So, 19 consequently, these guys are out there now depending on these 20 rate meters. They're mandatory. The regulatory body says 21 they're mandatory. They figured they worked pretty good. So, l
22 now, they'reLnot using the survey meters as well as they did l
23 before because the survey meter may be cumbersome climbing up the i
! 24 side of a tower, especially that water tower he was talking about
~
- 25 there.
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1 We have notified the NRC of this. We've notified 2 Texas of this. And at this point, as far as I know, nothing has 3 ever been done, not even a good comment period to go around the
- 4 industry to see how many people in the industry have experienced 5 this same problem.
6 (Pause) 7 MR. SPEAKER: My name is Kevin Cooper with Technical 8 Welding. I'm the RSO here for our shop here in the Houston area.
9 Just to make a few comments. One about our equipment is that our 10 equipment within our company is old. It's not that it's ancient 11 or anything. I mean, some of it's probably ten to fifteen years 12 old, but our equipment has been well maintained. We have 13 documents that can go back on each piece of equipment. All of 14 our equipment, whether it's a source tube or an extension or a 15 control assembly is uniquely identified with a serial number. We 16 have a serial number and an inspection sheet for each piece of 17 equipment in a file. We keep up with our stuff every'three 18 months as the Texas regs tells us that we have to inspect and 19 maintain our equipment.
20 The radiographers within our company is not 21 allowed to do the maintenance on the equipment themselves. The 22 equipment maintenance comes from either myself or the people that 23 work on my staff only. They're the only ones that are authorized l
24 to do i.his. Therefore, nobody else within the company is allowed I
- 25 or authorized to the maintenance of the equipment because of the V
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i 1 -- even though that they know how to work it. They've been a l
2 radiographer for several years. They do not have the technical 3 aspect, and when they take something apart to find out if it's 4
been worn, we check the tolerances on our pistol grips with the 5
bearings and everything, and if it's worn, we replace it.
6 So, we change bearings on our controls probably 7 about every six months. But when I buy a brand new set of 8
controls from wheth it's Amersham or SPEC, wherever we buy our 9
controls from or what I need and my bearing goes out, what am I 10 supposed to do? I can't go back and certify and tell you that, 11 yeah, I can tell you when I replaced the bearing, but was that 12 bearing an approved bearing to put in there? I just go down to a o
13 Id bearing company and I get the bearing that fits it and I put in 14 it.
15 And on a couple of other comments from the 16 gentleman from Oklahoma, when we bought our SPEC-150 cameras --
17 that's all we have in our company, and we own pretty close to 30 10 SPEC-150 cameras, and I love them. I have no problems with them.
19 I wouldn't have anything else other than a SPEC.
20 Donny's paying me a lot, I'll tell you what. When 21 it came up about these cameras on these -- cameras we were going 1
22 to go with this time last year, we had made our assessment 23 between the Amersham and the SPEC, and we decided that we within 24 our -- with what we wanted to do with, we went with the SPEC, but 25 we had a problem with both cameras. And the problem with both
(
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v 1 cameras is that we do a lot of internals, and I don't know how 2 many people here do a lot of internals. I'm sure if you're out 3 in the plants and do fab shops like we do, you're going to come 4 to internals, where we go inside and we shoot. Well, the problem 5 was with either one of the cameras is that once this camera is --
l 6 you've exposed it and you brought it back in, well, you're kind 7 of stuck. You cannot operate the camera without having to go j
8 back in there and unlock the camera.
l 9 Well, it came up with the SPEC, and through the 10 meetings and everything is that SPEC was going to develop a piece 11- of equipment that's called a RUM for short, but it's called a 12 random unlocking mechanism -- or a remote unlocking mechanism, l
13 where the camera is unlocked from the pistol grip being 35 feet 14 away from the actual device. And we've got this. We were the 15 first company to -- in the top 48 states to receive this RUM, and 16 we got the very first one.
17 In our meantime when we were waiting for this l
l 18 piece of equipment to be made, SPEC was already manufacturing the 19 piece of equipment, finding out how we were going to work this 20 thing out. In the meantime, we were calling and writing to the 21 state of Texas on this piece of equipment, finding out because 22 of -- we felt like this might be within an exemption for the 23 Texas regs to put this on our license to use it because it was 1
24 something that was going to be added onto the camera to unlock
- 25 it.
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O 1 Well, we get our letters back from Texas, and we 2 get the -- and in the process, SPEC gets their request back from 3 the NRC, which we do hold a NRC license and a Louisiana license.
4 Between all three states, the word was use it; we didn't need 5 anything. In other words, the NRC did not see this piece of 6
equipment being a certified or an associated equipment with the l 7 camera, even though it connects right to the controls and it i
8 operates the camera. But we didn't need any kind of l 9 certification to use it. Texas said go for it. So did NRC. So, 10 we're using it, and we have no documentation on it other than I l 11 know that the piece of equipment has been tested because SPEC did 12 not want to just give it to us without it being tested underneath l f 13 ANSI certifications or anything. We have it and it works great.
14 And I do know that there are some other companies 15 that I've heard from our supplier that has these things now, that 16 they're using them, and they're working out great. See, so 17 there's a piece of equipment that needed the approval or we l
18 thought we needed the approval from the NRC, and the only thing 19 the NRC said was we don't certify things like that because they 20 use that -- I know Texas, their words is that it's considered ;
21 that our control cables, source guide tubes, and our extensions, 1
22 we do not have to be licensed to or registered to use that 23 equipment; therefore, why should you register this piece of i
24 equipment. And that's the same thing that the NRC said.
25 So , you know, that's just some equipment that --
[h v
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v 1 between the equipment that we have that's being maintenanced and 2 equipment that we use that got us out of this little problem that 3 we had about securing or unlocking this piece of equipment while 4
it was inside a piece of pipe or inside a vessel, that greatly 5 helped us out on our production of it. And due to -- to make I
! 6 another comment is that the problems that we've ever had with 7
people within Technical Welding as of all of our companies, if a l
8 l person got hurt or got an overexposure with using the equipment, 9 it wasn't the equipment that gave them the exposure. It was the 10 individual themselves that did not use a survey meter or they I
i 11 didn't crank it in all the way or they put the equipment within a 12 bind or in a location that the source went out, but it never came 13' back in, and therefore, them not using their survey meter, they l
i 14 walked upon the source.
15 Now, I don't know why they would do that.
l Every 16 company in here has O&E procedures, and we tell our people that 17 survey meter has got to be with you. You're going to wear it.
18 ye,s like a watch. Don't let it down; don't put it down. And l
1 !
19 therefore, they do it anyway. So, the equipment is not what 20 gives the exposures. It's the people that give themselves the 21 exposure by not following the operating and emergency procedures 22 set forth by the company, not~the equipment. And so, you've got 23 these new cameras out, and we've all had to buy these new i
24 cameras.
And we've got people today that's gotten overexposed,
!. 25 and we thought and the NRC thought that because of the locking --
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- O 1 automatic locking camera that this would result in less 2 overexposures to an individual. But as we find out, the camera 3 didn't do it. It's the person.
4 MR. SPEAKER: You didn't train him well enough, Kevin.
l 5
MR. SPEAKER: Yeah. That's what everybody says. We 6
didn't train them well enough. So, you know, as I can see is 7
that all this associated equipment is not getting anywhere. The 8
equipment is fine. The inspections that I have had in the past 9
with the state auditors that are in this room, they know my 10 equipment; they know our equipment; they know it is in excellent 11 shape. They have seen the equipment. They know everything about 12 the equipment. I give it to them.
, And we've never had one 13 violation on our equipment, none. l 1
14 MR. SPEAKER: Did he buy your lunch to say this?
15 MR. SPEAKER: No, he didn't buy my lunch.
16 (Laughter) 17 MR. SPEAKER: So, anyway, that's -- thanks for 18 listening to me.
19 MR. NELLIS: Okay. I just want to respond to that last ;
1 20 remark -- set of remarks there. The original ANSI standard N432 21 has -- I don't believe it has anything about locking the source 22 in there, but there's a requirement in the rule that you have to 23 go up and physically lock the source in position at the end of 24 l every shot, and I know this is difficult to do when you're up in 25 strange places and up in high altitudes and the various places JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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l O 1 down in pits too and so on. And Donny DiCharry has been very 2 active in opposing this and wanting to put on a release at the 3 remote so you can do it at the control. And I just wanted to let .
4 uAl39 -
9) you know that the new standard, ANSI standard N4 C .F has that in l l
5 there. And it says:
6 Exposure devices shall automatically secure the 1 7 sourceassemblkinasecuredpositioneachtimethesource 8 assembly is returned to a fully shield position within the l
t 9 exposure device. It shall be possible to release the Y'O L U S)TA L)'
10 automatic securing device only by means of a JonSI--
11 operation on the exposure device or on the remote control.
12 So, that is allowed on the new one, but it's not 13 in the present standard. That's one thing I wanted to address, 14 and then the gentleman over here was talking about the task 15 force. He thought we were raising a lot of money. I just wanted 16 to point out one of the things that came out of the task force i
17 is -- if I can find it here -- okay. This is not part of 432 l
l 18 because we added we had a task force because we didn't think the ,
1 19 standard as it was being developed had a sufficient in it. And I 20 of course, the task force was formed'before the ANSI standard
! 21 first came up. And it says:
22 The coupling between the source assembly and the 23 source control cable must be designed in such a manner that 24 the source assembly will not become disconnected if cranked 25 outside the guide tube.
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lO 1 Prior to that time, nany of the sources were
)
2 cranking out and they were falling off. So, there was a l 3 connector designed and it was tested and so on through the 4 auspices of this task force to, you know, to prevent that sort of 5 operation. And there were several other issues. If you'11 6 notice, the first paragraph of 34.20 says you will follow 432,
- 7. and then there's a whole bunch of additional things. And once l l
8 those other additions came out of the task force, and this task 9 force included not only NRC people, but people from Louisiana, i
10 Texas, California -- were you on that one, Donny? I don't j 1
11 remember. I l 12 But anyway, there were quite a number of people on l O
V 13 there, and Tony C. in the NRC was on it, and it formed the basis l
l 14 of.this regulation. And they have gone out and they traveled 15 around the country and met with radiographers and so on. So, it i
16 was something in' addition. So, it wasn't really a waste of time.
17 We went out there to try to find out what the problems were and 18 tried to solve of them. We may not have got them all, but we did 19' get some of them.
20 And then coming back to one other comment about 21 the alarming rate meters, I don't want to get into what we should l_ !
22 do and shouldn't do about those' things. But the only rate meter 23 1,ve_had and had some sent to me, they have a little hole in the j
'24 side of them. You can take a paper clip and punch them'in there 25 and you get a little beep, and that's supposed to be an l
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l indication that everything -- all the connections and everything 2 are working correctly.
l That's what my understanding is. I don't l
l 3 know how you check them. I don't think you should have to check 4
them in a 500 MR field. I think that they should be checked 5
OY maybe with a calibration, so if they don't work, then I would
&{
i 6
like to know the names of the companies and so on, and I think we 7
could find out what's going on.
8 MR. SPEAKER: Well, probably the one you were looking 9 at was the NDS manufactured here in Houston. And with a small 10 check source, it's kind of hard to get a small source to put out i
l 11 500 MR per hour. I bet you won't lay it around on your desk.
I 12 And that's what it takes according to the NRC, 500 MRs whether 13 they're designed to start going off at. According to the NDS, ,
1 14 when I really got into this problem, they told me that they had 15 originally asked the-NRC about putting a high-low switch on the 16 rate meters and were told that they would not be accepted with 17 the low rate switch, rhich you could walk up to the side of a 18 camera or a check sot e and the check the rate meter.
19 And all it does when you stick the paper clip in 20 there, and if you read the operating instructions on everyone 21 y,ve seen -- maybe there's some different brands that I've l 22 haven't run into yet -- all that does is a battery check. It's 23 just like a survey meter. You know, you can check the-batteries 24 on a survey meter and the batteries will check on every line that 25 you use and all the rest of them. .
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1 MR. NELLIS: I understand that. I was under the l j 2 impression this was supposed to also check the circuit.
3 l MR. SPEAKER: No, sir, it cannot. It cannot check the l i
4 circuit. It's like a survey meter. A survey meter, you know, 5 .the battery check will check, but it may not be reading j 1 6 radiation.
7 MS. TROTTIER: Okay. I do want to bring up one issue
-8 here related to the alarming rate meter. The topic of this 9 workshop is 34.20. Okay? If when get all done and everyone has 10 brought up all the comments that they have about 34.20 and you 11 feel a burning need to express your views on this subject that we 12 alr'eady know all of your views on, we'll entertain them.
13 I do want to say this about it. Unen the final 14 rule comes out, the agency has taken a position on alarming rate 15 meters. It may not be popular with some, but currently, it is 16 our position. If the Commission so agrees with us, then that's 17 what the final rule will say. .There is nothing wrong with the 18 system that Amersham used to deal with the problem of associated )
19 equipment. If you feel you have a major safety problem with the 20 continued use of alarming rate meters, you are always welcome to
-21 petition the Commission to change our regulation, but we have 22' evidence that shows that we have lowered overexposures.
23 Therefore, until proven otherwise, that is 24 probably going to remain the position of the NRC. It's not that 25 we're ignoring letters. It's not that we have just chosen an JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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1 illogical path. We have what we believe is sufficient evidence 2 that indicates that this is an' effective tool. It's not the only 3 tool, and it should never replace survey meters. But since the i
4 topic here is associated equipment, I would like to defer any 5 more comments on alarming rate meters until the end of this j 6 session. Okay. Thank you.
7 MR. SPEAKER: I'd just like to clarify the statement 8 about the task force. I didn't say it was a total waste of time.
9 I said the feeling that they needed to mandate regulations 10 l concerning associated equipment was a waste of time and money, 11 not the whole task force. Thank you.
12 MR. CAMPER: Let me, if I could, help to -- again, from 13 our advantage point, knowing what we have to do when we leave 14 here, let me try to put some structure back to the discussion. I 15 mean, you're free to talk about anything you want to talk about, 16 but in terms of using your time as effectively as you can while 17 you have our ears.
18 There have been several suggestions thus far about 19 what to do, and the ones I've heard are something like -- go like 20 the following. Perhaps we ,could pursue revising what the ANSI 21 standard should applyEb Lto those essential components of a 22 system that Donny, for example, described rather eloquently.
23 Another option that's been discussed is self-certification.
^24 Another variation of that has been self-certification with 25 perhaps some minimum checklist that would be followed in terms of O
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1 the baseline things. I 2
Another suggestion has been the certification by ,
l 3 radiation safety officers that the equipment essentially is safe 4 to use and acceptable. Another suggestion has been the idea of 5 trying to remove the associated equipment consideration from the l
6 regulations and go toward a checklist approach only. And of 7
course, another suggestion was you see no safety significance, 8
and you ought to just take this out of your regulations entirely.
9 I guess what I would like to know from you are there any other 10 recommendations that we could consideration as we try to figure 11 out what to do next? I 12 (Pause) !
14 This is 34.20 that I wanted to talk about, Company. Yes.
15 associated equipment. Larry, you challenged us this morning and 16 asked us to talk about five different things that I wrote down.
17 Number 2, alignment of the How much of a problem is this?
10 states, the Agreement States with the NRC. This is where I see .
19 the big stumbling block. If this requirement with associated 20 equipment remains in the NRC regs, the Agreement States have the 21 option to either enforce it or not enforce it. That's happened 22 now with other equipment that's in compliance with ANSI N432.
(
I 23 Some of the Agreement States have already agreed to exempt pipe 1
24 liners for example from the requirements of 432.
25 So, this is where I see one of the problems of lc i JUDICIAL TRANSCRIBERS OF TEXAS, INC.
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- 1 leaving it in there. Now, Donny made the suggestion to put the l 4 l 2 requirements for checking the associated equipnient in another l 3 section of the NRC requirements for the manufacturer to do. If 4 the associated equipment parts were taken out of 34.20 and put
)
1 8
5 somewhere else, associated equipment wouldn't have to be worried l 6 about. Agreement States wouldn't have to worry about whether 1
7 they're going to enforce it or not enforce it, whether they're 8 going to exempt it or not exempt it.
i 9 Part of the problems I have is if the NRC gives me 10 an exemption to use a "J" tube, a centering device, etcetera, and 1
e 11 I have a NRC license and a Agreement State license, I take that t
12 exemption to the Agreement State, Agreement State may say no, you 13 can't use it in my state. That's presently happening with 432 14 equipment. Some states have automatically amended our licenses j 15 to list nonapproved equipment. But the NRC said you had a good 16 faith option that if you were going to get replacement equipment,
-17 you could continue to use it until the replacement equipment came 18 in. But.the Agreement States said no, we don't want that. If 19 it's not on the list of equipment, can't use it.
j 20 So, I see a big stumbling block here with
- 21 compliance, and we've heard for the last two days since we.were 22 here is how much we are alike and how much we're'different in the 23 Agreement States and the NRC.
24 The'other -- one of the other things you asked us 25 is why shouldn't this apply. Why should not associated equipment
( .
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1 be included. My response to that is that there are special l 2 applications that need immediate approval to perform an important )
3 task such as jet engines. We talked about that. Also, I l
4 co111mation. There are collimators out there that are not being 5 used. What is the purpose of collimation? ALARA [sp.ph.] To 6 protect the health and safety of the individuals. Therefore, we 7
need some other recommendation as to how to handle those items.
8 I don't have the answer for that 100 percent. Donny's item to 9 put it somewhere else in the regulations makes sense.
10 Public safety and health concerns -- let me 11 back up. If somebody were to interchange components, would it 12 adversely affect public safety and health? I think Earl said it I 13 V very well, that if I change some pieces and parts out, it's not 14 going to change that piece of equipment. I think the 15 manufacturers know that their pieces of equipment are safe and j 16 operate -- and how they operate, and the manufacturers work l
17 together sometimes on that, believe it or not.
18 So, I think the pieces of equipment out there are .
1 19 safe. I think they're interchangeability items that need to be l 20 addressed by the manufacturers, and I think we can continue to l 21 work a safe system so that we can maintain the health and safety. l 22 The other item was tell us what to do. Is it 23 reasonable and is it technically valid. Larry, you said you had
~24 to put some type of technical paper or summary together that I 25- assume somebody reads that says it's not just a good idea; why is l
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-t O 1 it a good idea, and what do we do next. Donny's suggestion is 2 one item. Put the requirement for associated equipment on the 3 manufacturers.
4 MR. CAMPER: Can I ask a general question? What do you 5
mean by manufacturer? No, no, that's easy. SPfC and Amersham is 6
easy. Is the small company that creates a specific guide tube, 7
is that a manufacturer?
O MR. SPEAKER: That was the next thing. What should we 9
(
do? Is it reasonable and is it technically correct? I put down !
j 10 here as dictated by the manufacturer based on the industry's )
J l
- 11 needs. Okay. The RSO of that company as we've pointed out i 12 before has some special training, education, etcetera, and may be
. 'OQ 13 willing to take the responsibility to do that. I jotted down l
4
! 14 some other things as I listened to minimum requirements as to 15 what that should be. We talked about making sure that the "J" 16 tube or the centering device had a stop on the end. We talked 17 about it having a welded or a soldered or a brazed connection to 18 the coupling that attaches it to the exposure device or the guide 19 tube.
20 We talked about it being -- we didn't talk about 21 it, but I wrote down being as short as practical to do the job.
22 We talked about it being made out of stainless stcel tubing, 23 unwelded, but then the item comes up what about the teflon liner 2 /'
in the nuclear reactor. Do we have to insert to make a certain 25 exposure.. It doesn't meet all of that. So, we need some U
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l 1
.O 1 guidance somewhere to give that individual an option for a 2 special application.
3 I said for situations where a flexible tubing is 4 needed, the length shall be as short as possible to permit free 5 movement -- free movement of the source. The item is checked.
6 The "J" tube, the centering device, the teflon tube is checked 7 daily with a source to make sure that it permits free movement.
8 That's one of the things we talked about. That's how we know 9 that it won't get hung up, hung out in the unshielded position.
10 Technically feasible, I'm a radiographer. I don't 11 have all of that technical expertise. I don't know how to 12 address that, and as everybody has said, we've had these d 13 conditions exist for a long time, and the equipment has operated l' 14 - very good. Thank you. I 15 Did you have any questions for me?
j 16 MR. CAMPER: No. I think what I'm hearing you say the 17 manufacturer in the case of the example that I was citing, I 18 mean, that could be characterized as a manufacturer.
19 MR. SPEAKER: Yes.
20 MR. CAMPER: Let me just make another comment. I think l
21 I speak, I know, certainly for the others up here as well because 22 we talked about it at lunch time. You have certainly made a 23 compelling case that there's a problem. You have certainly made 24 a compelling case that there's an immediacy to that problem. You 25 have certainly made a compelling case that it is a complicated 0
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() 1 problem that will not go away. The associated equipment problem 2 is not an end of life issue, and the industry is changing. It's 3 going to continue to be a problem because you're going to ,
4 continue to find yourselves in unique circumstances. So, let me f
5 just share with you that we certainly heard that.
6 Now, I think that where we're focusing now -- and .
I 7 this was the point I was making a few minutes ago -- is the 8 question of -- I rattled off a half a dozen, roughly, I think, 9 suggestions that I heard. And for the recommendations or 10 clarifying articulation of those recommendations would be
- 11 extremely helpful. f 12 MR. SPEAKER
- Larry, I suggest a straw poll on your six l l ) 13 possibilities. Even though the population has diminished a !
! 14 little bit, maybe you'll get some sort of idea to consist just i 15 from those six things if you feel it's appropriate.
I 16 MR. CAMPER: We can do that. .Let me see if I can think 17 of them again. The first one would be -- is to revise the 18 regulation so that it's clear. The ANSI standard applies to only l ,
19 those essential components as articulated by Donny earlier this 20 morning. How about straw man show of hands. Okay. The next one :
21 was the idea that the associated equipment would be taken out, !
22 and it would be replaced with a self-certification approach in i
23 which the licensees would be expected to self-certify and no 24 e
criteria for that would be defined. It would just be the ) i 25 licensees would self-certify. How do you feel about that? j 1
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1 MS. TROTTIER: Do you want to record the number?
{
2 MR. CAMPER: We could do that. What was the first one?
3 Let me see the first one again. Let's do the first one. How 4 many hands were on the first one?
5 MS. TROTTIER: 14.
6 MR. CAMPER: Okay. We have 14. And for the one I 7 just --
8 MS. TROTTIER: Looked like two.
9 MR. SPEAKER: No certification at all?
10 MR. CAMPER: No. There would be -- you would self-11 certify, but there would be an absence of any criteria, and you 12 would simply self-certify that it was safe. Again, there would
( 13 be general catch words, that it was safe, posed no health and 14 safety problem. We see --
15 MS. TROTTIER: Eight.
16 MR. CAMPER: I have eight, nine. Another approach 17 would be that you would self-certify under defined minimal 18 criteria, such as an end stop would be in place and some of the 19 basic things that were discussed earlier today. So, self-20 certification with some minimum set of criteria. I see one.
21 Removal of associated -- was that two?
22 MS. SPEAKER: No. I've got another suggestion.
23 MR. CAMPER: Okay. Good. Another alternative was l
l 24 simply remove associated equipment from the regulation, period.
25 14. Let's see. Were there any others?
LJ ,
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1 MS. TROTTIER: Put it somewhere else.
2 MR. CAMPER: What? Oh.
The idea that the entire --
3 thank you -- the idea that the entire burden, if you will, 4
ensuring that associated equipment would be placed under the 5 32.210 approach for the manufacturer, and I think that what we're 6 hearing is the manufacturer would be broadly interpreted, that 7 term. In other words, it wouldn't just be the large 8
manufacturers that obviously come to mind. It would be when 9
someone -- when a licensee is manufacturing, you would need to 10 meet that criteria under 32.210. Seven.
11 Were there any other recommendations? Kate?
12 MS. SPEAKER: I kind of had a combination type 13 situation. I think the best option for us as a manufacturer for 1 t l 14 getting things out into the field is to take Donny's approach in l
15 terms of defining the four key partr that are critical to safety.
l 16 Get those defined as a system, get those registered under 32.210.
17 Anything beyond that, guide tubes, control, "J" tubes, would be 18 vo to the user to self-certify.
l 19 !
MR. CAMPER: Can I see a show of hands on that 1
20 recommendation?
j 21 MS. TROTTIER: That's a majority.
22 MR. CAMPER: That's the largest number yet. Kate, 23 would you please rearticulate that.
24 MS. SPEAKER: Kind of a combination of what Donny has 25 said earlier this morning and what we have suggested in the t
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q l petition, which shows the manufacturers working together once 2 again, is that we define the four key components that are 3 critical to safety as the minimum system. That gets registered 4
under a device review under 32.210. Anything beyond that system 5
then requiree nelf-certification by the user -- well, actually, 6 the manufacturer that's going to be using it. The guide tubes, 7 "J" tubes, jet engine probes, etcetera. Collimators.
8 MS. TROTTIER: Okay. Now, I just want to move into 9 rule making space. Rule makings are not popularity contests.
10 So, I don't want you to go back and think, well, this is what got !
11 the majority vote. That's what the rule is going to look like.
12 If it doesn't come out that way, what on earth is wrong with you, 13 NRC. So, I just want you to know I think it was a noble gesture 14
- that Larry had to take a vote, and I think it helped coalesce 15 ideas, but that doesn't mean that's where we're going to end up.
16 So, you know, take it for what it was. Okay.
j 17 MR. CAMPER: And she's a health physicist, not a 10 lawyer.
i 19 MR. SPEAKER: Is any of this given strong consideration 20 as to our opinions of this, then?' I 21 MS. TROTTIER: Oh, yeah. I'm just saying we just --
22 MR. SPEAKER: Well, why shouldn't it have some bearing 23 on --
L 24 MR. CAMPER: No. She's not saying it doesn't have any.
3
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1 does not necessarily mean that's what the rule will ultimately I 2 look. I think I had a cliche yesterday. You know, watching rule 3
making take place is an intricate process like making sausage.
4 You know, you don't want to watch either one being made.
5 But there's no question about it that your 6
comments and the straw man -- it certainly helps us if nothing ;
7 else to collate the ideas and get some idea where the crowd 8
generally seems to be. That helps us to formulate what we think 9
is the most reasonable recommendation, but there are many, many 10 steps to the rule making process. That's all Cheryl was.saying.
11 MR. NELLIS: Well, what happened to the other majority 12 that didn't voto? It seems there's about 40 or so people in the (Q 13 room and the maximum number we had was about 17 show of hands'.
14 That means more people --
15 MS. TROTTIER: No, no. A lot of people voted. We have 16 14 here -- )
I
! MR. NELLIS: You've got 14, 14. If you add them all 18 up, they just barely -- well, they may come to this 40.
19 MR. CAMPER: Some voted three times. Yes.
20 MR. SPEAKER: Larry, I have two comments away from I 21 I don't want to kill the 34.20, but I do have two other 34.20.
22 comments.
j 23 MR. CAMPER: Go right ahead.
24 MR. SPEAKER: I don't think either one of these 2
25 comments will require rule making. As I understand it, one has
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'w) 1 been promised, but I think it's a long time coming, and that is, 2 there is a burning need to get the Type "B" package quality 3 assurance program away from the separate certificate of 4 compliance and rolled over into a single license so that you 5 people as radiographers can have a concise program. I understand 6 that has been promised. It may be in the -- I don't see why rule 7
making is necessary, but if it is, let's get it done and get on 8 with it in that particular one.
i 9 MS. TROTTIER: I believe unless something radical 10 happens in the next few weeks, that will be in the final rule.
11 MR. SPEAKER: Thank you. The second comment is I would i
12 like to recommend that we get away from what I think to be a
{y f
J 13 silly game of playing model numbers in licensing, and that is, 14 matching up camera models, source models, source changers. I 15 think that process can be simplified greatly without rule making.
16 I know that Region 1 tried it. I think in certain cases, I don't 17 see any reason why this whole process of putting the licensee 18 back through the problems of sending in an amendment which is 19 rather costly simply because somebody has changed a series or a 20 model number.
21 We're all in radiography. The operating and 22 emergency procedures are not going to change to that significant 23 of a degree. So , I think that can be a way of generically 24 licensing or putting in models in some way to overly simplify the
! 25 silly game of model numbers, source model numbers, and source
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l lO l 1 changer numbers that is I think very time consuming and very l
2 expensive. Thank you. ,
3 MR. CAMPER: Well, thank you. But I totally agree with 4 your comment. When we were going through a process recently, we 5 were involved in looking at the Amersham 615 and 615L System. We 6 found much to my chagrin that the regions were in fact licensing l 7 systems differently. Two of the regions were specifically 1
8 identifying systems on the license, and two of them were using 9 more generic approval, in that the device had undergone a 32.210 10 process or an equivalent Agreement State process. I think that 11 latter or the latter approach, by the way, makes much more sense.
12 The idea that you can use a system that's undergone review as ]
! O 13
! () opposed to identifying a specific long series of cameras that may 1
14 become obsolete, which may have'a change of nomenclature. l 15 I mean, the bottom line is it's undergone a review gafe 16 and it's g to use. So, I certainly appreciate your comments,
,I 17 and I do have an effort to correct that problem, by the way.
18 Other comments.
19 MR. SPEAKER: Donny DiCharry. Earl, don't leave yet.
20 MR. CAMPER: I thought someone was supposed to get his l
21 notebook.
1 22 (Laughter)
' 1 4
23 MR. SPEAKER: I just wanted to add on to a comment that l 24 Earl Banfield made earlier regarding the need to evaluate rules I 4
25 based on its cost benefit t,s the industry. And in order to be r)
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o U 1 l able to do that type of cost benefit analysis, the industry and 2 the NRC really does need relevant data. We have been talking 3 thus far about the number of overexposures that occurred in years 4 past versus how many have occurred since these new rules have 5 gone into effect. And I would like to point out that the number 6 of overexposures is really not relevant to this topic of
- 7 associated equipment. It is only the number of acute 8 overexposures that somehow can be related to an equipment i
9 malfunction that involves associated equipment.
10 The total number of overexposures is much greater 1
11 than the very, very small limited number of acute overexposures 1 I
l 12 that somehow can be related to associated equipment malfunctions. I (O,/
13 And if that overexposure data is segregated along these two line, 14 chronic overexposure versus acute overexposure, I think what we 15 would see is even greater evidence that the cost of the .l l
16 associated equipment rule is very difficult to justify from a ;
17 cost benefit relationship, i 18 And that conveniently allows me to, if I may, make 19 a comment on the need for good data, even also in evaluating the 20 alarming rate meter rule. The NRC has stated that it has 21 ~ indications that the rule is good and useful. If the NRC has 22 data to support their position, then I would request that that 23 data be published so that it can receive the same sort of peer 24 review and same sort of critique that a cost benefit analysis 25 would as well. Thank you, a
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A U 1 MR. SPEAKER: My comments before -- really, the whole 2 basis of my comments before is that, you know, in safety, what we 3 would like to do as companies in the area of safety is to put our 4 resources where the most benefit is achieved. It really doesn't 5 do us any good to spend our money in time and areas where we're 6 not getting any reward in safety. We want to make it as 7 effective as possible. And I think that's what Donny alluding to ,
8 as well.
9 The other thing I'd like to comment on is part of 10 this rule, when people talk about not using collimators because 11 they can't comply with the rule, I have a real concern about the 12 philosophy of ALARA with that, and I believe the Commission has
( 13 to have that same concern. And I think it really needs a serious 14 look.
15 And lastly, you know, you talked about -- Larry, 16 about -- we're talking about compatibility in components. We 17 really can't forget -- you know, and this really relates to the 18 manufacturers and distributors more than somebody building 19 something in their individual offices. But there's a thing 20 called product liability, and they have a severe exposure to 1
21 that, and I'm sure they can explain that a lot better than I do.
22 If I had a piece of equipment that didn't operate safely, and, 23 you know, they could be held liable for that product. So, there 24 is some -- you know, there is an enforcement mechanism in there 1
i 25 anyhow. It's just part of our everyday business, not to mention l
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our own programs.
2 Anyhow, thank you.
3 MR. CAMPER: One comment on the collimators. I share 4 your concern. As I said awhile ago,.I have a sense that there's 5
an -- there is an' immediacy here, and one of the things that 6 compels me to believe that is the collimator problem. The other 7 one is is that -- is clearly the uniqueness and in some cases the 8 time urgency, what you're doing and what the need for specific l
9 pieces of equipment are. Well, I've got'some other things too, 10 but those two come to mind. But there is an immediacy here, and ,
11 the collimator problem is troubling. l l 12 MS. TROTTIER: Okay. If there aren't any other 13 comments, 1 would like to thank you all for taking the time to 14 come. I think what this workshop tells me is we probably need to 15 do this more often. A-lot of the times, we're worried about 16 adding expense to people's lives by bolding workshops where they .
1 17 need to travel, and since this happened to be a time when a 18' workshop was occurring that we thought would draw a large number 19 of you anyway, it seemed reasonable. But I think maybe in the 20 future, we will attempt to do this more often. And to be honest, 21 you know, maybe had we done this six months ago, we would be way 1
r 22 ahead of the game now. But unfortunately, at the time, we didn't 23 make that de' cision, but, you know, we learned a lot here, and I
- 24 think-in the future, we'll-be more prone to try and hold these q 25- workshops prior to us undertaking some activity that ends up 4
y/
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l (3 IV j 1 adding a great deal of burden.
l ,
j 2 One of the problems that our agency suffers from 3 and I'm sure you can understand this is that we spend an enornious 4
number of resources regulating a hundred licensees, who for good l 5 reason could kill many people if they were not regulated 6 properly. So, I guess that's fine. But the problem with that is
- 7 that our system is set up to focus around those licensees. Those 8 licensees have huge resources.
l Every time we do something, they 9 know about it instantly. They have people polling the Federal 10 Register daily to find out what we're doing. They hava people in 11 our public document room everyday trying to find out what we're 12 doing.
I b
I (,; 13 And unfortunately, the problem with people in this 14 industry is you don't have time to sit and read the Federal 15 Register everyday. And so, many times, we take actions and by 16 the number of comment letters we get, I realize that you're 17 probably not even aware of what we're doing until we've already 18 done it. So, maybe having these meetings helps to avoid some of 19 those problems in the future.
20 Anyway, I want to thank you all for coming. And I 21 guess Jim wants to make a statement.
22 MR. SPEAKER: Yes. I'm Jim Myers. I'm with the Office 23 of State Programs from NRC, and this is really Larry and Cheryl 24 and Don's show up here. But I would also express our thanks from 25 the state program side of the NRC for your attendance, and I'd r i i L/
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O 1 also like just maybe to point out that back in March, we had a 2 workshop in Vancouver. It was in conjunction with the 3 organization of Agreement States. Cheryl attended that meeting.
4 I was there, and Cindy Cardwell, who is from Texas who had to 1 5 leave, Cindy I co-chaired that.
6 One of the recommendations that was made by OAS 7 back to NRC subsequent to that workshop was that a future I
j 8 workshop be held to address the implementation of parts --
i f
9 sections of Part 34. This was one of them, and the meeting ,
1 10 yesterday, also, I think was part of that agenda that NRC l 11 listened and did hold the workshops.
12 I would also say that if anyone has an interest, l j -( ) 13 there are a couple of other recommendations related to equipment 14 that came out of the discussions on 34.20 at t?st workshop. So, 15 I guess what I'm trying to say in the bigger .cture is that, l 16 certainly, the Agreement States have an int Jast in this issue, 17 and I think we're all trying to get together and communicace and 18 come up with a solution to it. And thanks for coming.
19 (End of workshop) 20 21 22 l
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