ML20217M005
| ML20217M005 | |
| Person / Time | |
|---|---|
| Issue date: | 10/20/1999 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9910270118 | |
| Download: ML20217M005 (139) | |
Text
{{#Wiki_filter:. ORIGli'lA _ UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION j l
Title:
MEETING WITH ORCANIZATION OF AGREEMENT STATES AND CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS PUBLIC MEETING Location: Rockville, Maryland Date: Wednesday, October 20,1999 l Pages: 1 - 97 : O 'y c/ l Le l 9 ! h
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" , LThis'is'an unofficial *.ranscript- 'of a meeting of
.the United State's;NucleariRegulatory. Commission held on
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- OctoberJ20, 1999, fin the C.:mmission's office at.One White
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cFlint North, Rockville, . Maryland. The meeting.was open to
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m J.public~ attendance and observation. This transcript has not m been reviewed,-corrected'or edited,.and it may contain i
'- inaccdracies. j i
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The. transcript.is' intended solely for general
.informationalJpurposes. As provided by 10 CFR 9.103,-it is I y 'not'part;of
- the' formal or informal' record of decision of the matters. discussed. ~ Expressions ~of' opinion in this' transcript do.not.necessarily' reflect final ~ determination or beliefs. .No1 pleading or'other paper may be filed with the I Commission in'.any procee' ding as the result of, or addressed t o ,- any?statementJor argument contained herein, except as the Commission.may authorize.
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8 g a f 1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 OFFICE OF THE SECRETARY 4 *** 5 MEETING WITH 6 ORGANIZATION OF AGREEMENT STATES AND CONFERENCE OF 7 RADIATION CONTROL PROGRAM DIRECTORS ) 8 *** j 9 PUBLIC MEETING-10 11 i 12 Nuclear Regulatory Commission 13 One White Flint North l 14 Rockville, Maryland 15 Wednesday, October 20, 1999 16 17 The Commission met in open session, pursuant to 18 notice, at 9:27 a.m., Greta J. Dicus, Chairman, presiding. 19 20 COMMISSIONERS PRESENT: 21 GRETA J. DICUS, Chairman of the Commission 22 EDWARD McGAFFIGAN, JR., Commissioner 23 JEFFREY S. MERRIFIELD, Commissioner 24 25 ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034
l 2 l 1 STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE 2 ANNETTE L.-VIETTI-COOK, Secretary of the !
'3 Commission 4 STEPHEN G. BURNS Deputy General Counsel 5 STANLEY R. MARSHALL, OAS Chair.
6 ROBERT M. HALLISEY, CRCPD Chair-Elect. l l 7 EDGAR D. BAILEY, OAS Chair-Elect i 8 RICHARD A. RATL1FF, PE, LMP, OAS Secretary ) 9 ROLAND G'. FLETCHER, OAS'Past Chair ) 1 10 DAVID K. WALTER, Chair, SR-6 Committee l l 11 12-1 13 l i
'14 15 16 17 18 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.
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l. 't. 3 1 1 PROCEEDINGS i l l 2 [9:27 a.m.] 3 CHAIRMAN DICUS: Again, good morning, ladies and i
'4 gentlemen.
5 On behalf of my fellow Commissioners, I would like 6 'to welcome representatives from the Organization of 7 Agreement States.and the Conference of Radiation Control l 8 Program Directorr, to discuss topics of particular interest 9 to our regulatory programs. 10 .I would like to recognize that this briefing is i
'11 part of an ongoing constructive dialogue on a continuing i 12 exchange of information between the states and the NRC 13 concerning areas of mutual interest. j 14 Today, we will hear from the OAS, Organization of 1
15 Agreement States, and the CRCPD, Conference of Radiation 16 Control Program Directors, regarding several issues, CPT' s sincluding the OAS resolution in support of NRC's budget, the 18 DOE pilot program as it relates to the states, NRC's 19 allegation protocols, a petition for rule-making on the 20 topic of source material, 10 CFR Part 40, continuing off-run 21 source initiatives, release levels for solid materials, and
.22 the Part 35 medical rule-making proposed draft final rule.
23 I would ask that, before you begin each of your 24 presentations, please introduce yourselves, provide your 25 affiliation, either the-OAS or the CRCPD, and identify the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.. 20036 (202) 842-0034
4 1- state that you are from, and we may stop your presentation 2 from time to time to ask questions, however we will try to 3 let you get through your presentation with minimal 4 interruption and save our general questions till the end of 5 each of your presentations. 6 Do any of my fellow Commissioners have any opening
.7 remarks they wish to express?
8, COMMISSIONER MERRIFIELD: Madam Chairman, I'd like 9 to add my appreciation for the representatives to come in 10 today. I think the relations between the NRC, the agreement 11 states, and the CRCPD are important. I look forward to 12 having an opportunity for a good dialogue today. 13 In a clarification, I take it that Madam 14 Chairman's intention is for us, at the end of each of the E15 presentations, to have an opportunity to ask questions on 16 the areas in that presentation? 17 CRAIRMAN DICUS: That's my intent, if everyone is 18 willing to do that, because each one is addressing a 19 particular subject. So, rather than hold the questions to 20 the end, I think at the end of each subject, it would be 21 appropriate to address the issues. 22 COMMISSIONER MERRIFIELD: I think that's fair. 23 CHAIRMAN DICUS: All right. 24 Well, if there are no further questions or 25 comments, then, Mr. Marshall, will you please proceed with ANN RILEY & ASSOCIATES, LTD. Court Reporters f 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
5 1 the briefing? 2 MR. MARSHALL: Thank you. 3 My name is Stan Marshall, from the State of 4 Nevada, and I'm pleased to be here as Chairman of the 5 Organization of Agreement States. 6 I'd like to quickly introduce Ed Bailey, 7 Chair-Elect for the Organization, Secretary Richard Ratliff. 8 David Walter from the State of' Alabama is also here. We 9 understand Roland Fletcher is en route to the meeting, and 10 also Bob Hallisey as Chairman for the Conference of 11 ' Radiation Control Program Directors from the State of 12 Massachusetts. 13 The purpose of the OAS briefing today is to 14 provide an update to the Commission about OAS concerns and l issues in support of the state-Federal relationship in a 15 16 longstanding national radioactive material program. 17 Briefing topics today will include Departmet-t of 18 Energy regulation and external regulation -- the external f 19 regulation pilot program status, by Ed Bailey; source 20 material exemptions, by Richard Ratliff, State of Texas; i' 21 comparisons of Part 35 and Part G, David Walter from 22 Alabama; and NRC allegation protocols, Roland Fletcher; 23 lastly, my closing remarks of the Organization of Agreement 24 State resolution to support the NRC proposed budget. 25 I'd like to turn thiF over to begin the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
6
?l' ' presentations.
2' MR.' BAILEY: My name is Ed Bailey, and as Stan
- 3. mentioned, I am.withfthe State of' California Radiologic
, 4- . Health Branch.and here representing the Organization of
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;5 Agreem'ent-States.
6- .Today;I'd.likefto make a short presentation cn the 7 external regulation. project of DOE facilities. 8 I.believe-you have copies of the slides. ' Simply 9 ' note.the. facilities that'have'been looked at in pilc* 10- , proj ect s .: Lawrence Berkeley National Lab, Oak Ridge 111~ ' National Lab, Radio-Chemical. Engineering Development Center,
- 12 and~ Savannah River Site for Receiving Off-Site Fuel.
5 13- California is particularly interested in the
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14- . external regulation of DOE because we have seven DOE sites i 151 in California. Some of those are fairly unique in that two ;
'16 aof those' sites are actually on State of California land;
'17 .three of them, the1 employees at the labs are' State of
'18 : ' California employees, not private contractors, not DOE 19 employees.
'20 When we get'into the models that were presented in i
21 the pilot studies, that becomes important, because Federal \ 22- LOSHA does noticover state employees, so that OSHA'would not { 23 bela viable regulator for the people at Lawrence Berkeley 1
*:24 " National Lab, Lawrence Livermore National Lab, as it turns 25- out ', Los Alamos. National Lab, because they're also employees
. ANN RILEY & ASSOCIATES, LTD.
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7 l' of the State of' California, and the smaller lab, the (2' Laboratory for Energy-Related Health Research at the 3 University of-California'at Davis. l l 4 -The reason we are interested in this, in SL regulating DOE,.is that a rem is a rem is a-rem, and it
- 6 'doesn't matter where it'comes from,-whether it's from AEA
'7 materials, whether it's from accelerator-produced 8- radioactive material, whether it's naturally-occurring, or 9 whether it's from machines, and we feel that there should be ICL ' consistent' regulation of all'these sources of ionizing 11' radiation, not only at our-licensees' facilities but at
- 12. Federal facilities.
- 13. The next part of my presentation, I'm going to 14 concentrate primarily on Lawrence Livermore -- I mean
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- 15. Lawrence Berkeley National Lab, because that's where we did 16 the pilot project.
17 CHAIRMAN DICUS: Before you go further, I'd like' 18 to acknowledge that Commissioner Dia: is on the bridge, and 19 it is a two-way communication, that he can hear.you and we 20 ~ should be able to hear him. I'd like for you to be aware of 21 that. 22- MR. BAILEY: Okay. l 23 CHAIRMAN DICUS: Please continue. 24 MR. BAILEY: All right. l 25 The Berkeley Lab was founded in 1931, is the l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,RD.C. 20036 (202) 842-0034 L
8 1 oldest of the national labs. It, of course, is named for 2 Earnest Orlando Lawrence, the invcntor of the cyclotron. 3 It's an unusual lab, because nine Nobel prizes 1 4 have been awarded to researchers at that particular lab. l 5 Also, when we look at all the trans-uranic elements, almost 6 all of them were discovered at Lawrence Berkeley National . I 7 Lab -- americium, Californium, berkelium. ) 1 8 -They've recently discovered two more elements I l 9 there, I think 116 and 118. { 10 So, it's been a focus of primary physics research 11 for a long time. 12 As I mentioned earlier, it is managed and operated I 13 by the University of California. The work at Lawrence 14 Berkeley National Lab is basically unclassified research in 15 basic sciences. 16 Presently employee over 3,000 people, sits in the 17 Berkeley Hills across the bay from San Francisco, totally 18 surrounded by the University of California at Berkeley, and 19 as I mentioned earlier, it has little or no weapons-related 20 work. 21 University of California has nine university 22 , campuses and three national lab campuses. The national lab 23 directors are on the same level, have the same status as the 24 chancellor of each of the U.C. campuses So, it's truly 25 integrated into the U.C. system. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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1 Lawrence Berkeley Lab is a rather unique facility 2 in that it has, as I've said,-very little weapons-related 3 material, and for the most part, it works with materials 4 that are not normally regulated by the NRC. 5 I've given a list here of the primary sources of 6 radiation that exist there: the advance light source; the l 7 Bevatron, which is not in production now; PET accelerator; 8 heavy ion accelerator. 9 The one facility that would be regulated normally 10 by NRC if it were a private business is the National Tritium 11 Labeling Facility, which literally sits in a building not 12 much larger than this room we're meeting in today, has an
-13 88-inch Cyclotron there.
14 The next slide shows sort of the history of the 15 Department of Energy and its self-regulating programs, 16 starting in 1946 with the Atomic Energy Act and going to 17 1977, where DOE was created as a cabinet-level agency. 18 The external regulation of DOE is already 19 occurring. The Clean Air Act Amendments extended NESHAPS to 20 DOE sites, and California is now in the process of signing 21 an agreement with EPA to assume regulatory authority under 22 NESEAPS. 23 So, we will be into the national labs. We will be 24 going and seeing anything that we would see regulating the 25 radioactive materials or other radiation sources there. l I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034 L
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10 I I 1 Also,fthe Federal Facilities Compliance-Act places
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' DOE sites under RCRAS LWe are. involved in -- or a signer.to c3. 1a FederalfFacilit'ies Agreement for the Lear facility at the
;4 University'of California, Davis,~which is cleanup.
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5 There are also existing NRC and agreement state 6; ' oversights.attother. DOE facilities,- and there's a list of
'7 them there.
8 I would mention just.in. passing that the fusion 95 facility;at General Atomics in San Diego -- I don't know 10- whether;they messed-up,.but they~ registered all of their 11 x-ray machines'with the State of California, and we 112' . regularly. inspect those facilities. 13' The drivers'for external regulation -- this is
~14. from the Ahearne Committee -- were safety, credibility, and
-15 . stab'ility, and I~think we will see that those can be 16 ~ afforded.
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-17' We have been involved at LBNL for'quite some t'ime. j 18 There's a list of different projects we've been involved I
19 'with as the State of California at Lawrence Berkeley Lab. 20 The external regulation-pilot, phase one -- that's
~21 when we met with NRC dnd did the original pilot.
22 After Congress said, hey, we want more involvement 23 by OSHA, we went back, and one of the big problems with I J24 having OSHA involved at all was, if you're not familiar, 25- OSHA is still on the 12-rem-per-year quarterly dose-based ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 c-
a 11 5 1 system.
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2 Their regulations are terribly out of date, and 3 so, it was really interesting to see them go in there and ; i 4 try to apply their regulations to a national lab. It just l 5- didn't work. 6 In fact, after the second day, the people from my j II 7 team that we e there called and said, please, may we come 8 1:ome , because we're looking at ladders, we're looking at , 1 9 electrical cords, we're not doing anything in radiation. I 10 'So, I let them come home. - 11 The external regulation process -- the next slide 12 gives sort of a brief. oversight of what has happened, 13 including the phase two pilot study. j 14 A few of these slides, including the next one, ! i 15 were given to me by DOE. {
-16 It doesn't show up well, but you can look at it in 17 your packet. This was presented by one of the people from 18 DOE at a meeting I was at recently.
19 The diagram on the left represents the DOE 20 structure for regulating and controlling radiation j 21 protection, environmental protection, and waste management 22 under the present system. j 23 This person, who is the radiation safety officer i 24 at one of the national labs, says, under external 25 regulation, which this particular lab very much favors, all l 1 I ANN RILEY & ASSOCIATES, LTD. ; Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 ; (202) 842-0034 j l l
w 12 li of-theLsudden.all of these three things that we normally E2' .think ofEas being under somefsort of radiation: safety head 3' come together;under a radiation safety committee regulated 4- by.an external regulator; 5 The'next slide shows some of the jurisdictional
'6 ' issues. The top shows NRC and OSHA, - OSHA covering NARM, 7e radiation-producing. machines'-- and'this is'at the present 8 time- whereas the states have a continuing spectrum of 9; . regulation'throughout.
10 .ALfew quotations that'have gone along with it: '
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11- 'The external regulation of DOE -- essentially all
-12 aspects of safety at DOE's. nuclear' facilities and sites
~13: 'should be regulated, externally.
114 "Mr.LChairman' the Department is ready to move 15 forward ~now to work'with you:and others to develop a path' 16' . forward to externally regulate single purpose Energy 17^ Research laboratories,"'and I think that's important. .< 18" The weapons program is sometimes held up as a red 19 herring. I 20 None of these external projects involved the 21 weapons program, it was always the energy program, although 22 we.could get into a discussion.of the weapons program, 23 because we also regulate f acilities, just as you do, which ] l 24 .are involved in weapons production -- namely, some of the 25 aircraft companies, shipbuilding yards, and so forth. .
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l n' J. l l 13 ' l' So, if clearances are needed, we and you have 2- those clearances; it's not a matter of national security, 3 really'. 4 The next slide are statements that were put into 5- the draft final report out of LBNL, and I want to read these , 6 two. 7 The first one is "LBNL agrees with the DOE Team 8 preference that LBNL'should be regulated by the same 9 regulators as private industry and academia. 'LBNL Ltlieves 10 that there would be a smooth and seamless transition to j 11 external regulation if'the regulator were the State of 12 California." 13 The next slide, "LBNL considers that the benefits 14 of external regulation are strongly dependent on the 15 -licensing model. LBNL believes that the only license model 16 that represents a clean break from DOE's self-regulation is 17 the model in which the University of California-LBNL is 18 licensed directly by the NRC or the State." 19 The main issues from our standpoint are who would 20 be the regulator, would it be the NRC, would it be OSHA, 21 would it-be Californid Radiologic Health, would it be 22 California OSHA? 23 Next issues are who would be the licensee, would 24 it be the U.S. Department of Energy, University of 25 California, or the lab itself? ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i L
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1 I might mention lthat'each ofJthe University of 2 1 California campuses holds a separate license to do their
- V ' operations. So, this would be just like adding another
- 4. license'to their pile of licenses.
5 NUREG-1708 just_recently was published, and there 6 -is.one huge l disappointment in-that document to the states, 7 and that's-the' statement'which follows. J
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8 "With respect to state regulation of DOE 9- facilities,. sovereign immunity should.not be waived and the 110 states should not regulate DOE facilities." 11- This-finding in the NUREG seems to'have some l'
- 12 , . contradictions.
13 I do not believe that that was the conclusion of
. 14' -the LBNL" site team from NRC. This was not the conclusion of ,
15 the. DOE Oakland operations. This was not the conclusion of 16 LBNL, and.this was not the conclusion of the State of 17 California. 18? 1The question, then, is whose conclusion was it? 19 In a humorous vein -- I hope you'll take-it this 20 'way'-- as we were going through the phase one or phase two 21 of the external regulation projects, one of the people from 22' the lab said to me, "I don't want to replace one regulator l 23 in Washington with another regulator in Washington," and I 24: think that sort of sums up'how some of the labs feel in that 25- they would like to be treated-as just any other commercial ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025. Connecticut Avenue, NW, Suite 1014 j Washington, D.C. 20036 { (202) 842-0034
a. 15 1: establishment or academic establishment in the state. f l 2. In closing, the Organization of Agreement States 3' recommends that the NRC aggressively seek regulatory 4 authority over DOE and its contractor facilities and, l 5 secondly, that NRC include the regulation of DOE
'6 contractor-operated facilities in the agreement state l
! 7 program, and I hope it'goes without saying that the 8 Organization of Agreement States continues to encourage NRC 9 to become the sole regulator of all sources of radiation, 10 whether they be AEA materials, NARM, or machine-produced. 11 I thank you. I'd be happy to take any questions 12 or comments. 13 CHAIRMAN DICUS: Okay. Thank you. Appreciate 14 -that. 15 Commissioner McGaffigan. 16 COMMISSIONER McGAFFIGAN: The answer to your 17 question is, I guess, us. 18 (Laughter.) 19 COMMISSIONER McGAFFIGAN: And I want to explore 20 that with you. 21 The big issue that you didn't come back to is 22 who's the licensee, and one of your diagrams shows that it 23 was a relatively clean diagram, whether it was the agreement
- 24 state or NRC, and it is the strongly held view of DOE --
25 well, they don't want anything, but if there was going to be ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 I Washington, D.C. 20036 (202) 842-0034 l l
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16 1 something',.it had beenztheir' view all along that they would 2 2 be the. licensee,'inz whichicase-you'get the smorgasbord box 3- rather than the cleantdiagram. 4 ' So, that's an important issue. We're,-I think, in 5~ agree on that, that the licensee needs to be -- and.I guess
'6' .you didn't come down as to what the university or the lab --
'7 it probably doesn't' matter that much between those two, but 8' it is not DOE' and.that's your recommendation, right?
9 MR. BAILEY: Yes, that certainly would be -- my 10 recommendation is that these laboratories, which to the best 11 of my.know] edge are almost exclusively run by a contractor 12 rather than by DOE -- that the contractor be the licensee, 11 3 that'the contractor being held responsible for compliance 141 with regulations, just as you see with the Department of 15 Defense where they.have' essentially captive laboratories or 16 captive manufacturing plants, and they don't exclude those
- 17. from regulation.
18 COMMISSIONER McGAFFIGAN: You just mentioned the I 19- Department of Defense, and that leads to the next issue. l 20 The VA and the DOD medical centers in your state and around 21 the nation are regulated by us, and we have not -- I mean 22 that's a longstanding approach, and it has some real 23- benefits, you know, for the VA in terms of dealing with a 24 single regulator, namely us, that has, you know, whatever j 25 rules we have applying Part 35 -- applying to their ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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17 1 facility, and that was, I think, the main thing that 2 motivated us and the. Commission and, I think, the senior 3- staff. 4 I don't know what the team that was involved in 5 the program review -- but that's what was motivating us to 6 think in terms of this other model, that we would -- and 7 obviously, if you do this other model, then we have to have 8 the ability to deal with the accelerators, because a rem is 9 a rem is a rem, we agree with that. l 10 But there is this other model, which is widely 11 used for other Federal licensees, and why doesn't that model 12 -- why can't that work in this case, and why can't that be a 13 real advantage for DOE in terms -- and its licensees in 14 terms of-having a single regulator across the country? U.C. 15 should not face New Mexico rules in New Mexico and 16 California rules'in California. They could face NRC rules 17 in both places. 18 MR. BAILEY: I'd like to address that. 19 The two examples you mentioned, DOD and the VA, 20 again to the best of my knowledge, in both cases those 21 facilities are operated by VA or DOD employees, not by 22 contractor employees. In other words, the VA does not go 23 out to UCLA, for instance, and say come across the street 24 and run VA-Wadsworth. It just doesn't happen, so that you 25 are directly regulating a Federal agency, and we think ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
A , i 18 1 that's proper. 2 COMMISSIONER McGAFFIGAN: But are oftentimes -- I 3 don't know the deal in California, but in New Mexico, the 4 big VA medical center in Albuquerque has all sorts of -- 5 it's right in a whole hospital complex, I'm sure they tend 6 to be, anG there's all sorts of work between the -- joint 7 work between the VA medical center and the large hospitals, 8 with one being regulated by us and the others being related 9 by the State of New Mexico, and it seems to work. You know, 10 somehow, when things get to be joint between the two, we ! -11 somehow make it work. i i 12 MR. BAILEY: Well I think there are numerous 13 examples -- almost every university reactor ends up having a 14 line painted on the floor that says here's NRC jurisdiction 15 and here's state jurisdiction. 16 We could look at the fusion facility, General 17 Atomics. We've got a working agreement now. That's a 18 facility -- that's an NRC licensee, a State of California 19 licensee, and a DOE facility, just as E-Tech -- used to be 20 Rocketdyne. 21 All three entities operate there, and you have 22 licenses, we have licenses, and DOE has their little niche 23 carved out. 24 We really don't see where you're talking about a 25 contractor operating something, that there needs to be this ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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'l - issue ofcsovereign immunity involved. Any one of those .
l 2 contractors could lose that contract at any time. i 3 In the case oflthe facilities we have in
- 4. LCalifornia -- and I'm sure it applies to other places --
5 those facilities are actually on State of California land, 6 some of them. The employees are State of California 7 employees. 8 We don't see why they need to be restricted to a 9 Federal license-if,one occurs,:and you mentioned that you do 10 regulate DOD. We're involved in-base closures ~in 11 California,.quite a large number of them. The major 12 problems-that we're finding at'DOD base closure is not AEA 13 material. 14 It's two categories of material: radium from dial ; 15 operations and nuclear weapons debris which was washed off L16 - of aircraft and so forth. And I don't believe you regulate 17 -either'one of those.
-18 So, we go in and try to work on those sites. We 19_ go in with~ EPA teams and so forth.
20 -We find that people are a little amazed that we 21 don't have authority.as they do under their EPA agreement to 22 set a standard and make that standard stick, say that's a 23' regulation, and I think that's an important aspect of a
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24- . nationwide,~ comprehensive, radiation protection program, is H25 that we.do have authority to regulate all sources of ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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1 regulation -- most states have that.in their-provisions -- ! 2 and 'that any derive 3 authority that we have through the
, '3. ' Atomic EnergyfAct,.through NRC,: covers all the sources that' l
4 'you can' cover. ] 5: COMMISSIONER McGAFFIGAN: - I won't. pursue this much 6 tloager. Unfortunately, as you well know, the political I
;7 . ,climace;in Washington, given' Secretary Richardson's
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8- Lopposition,:the prospects for this legislation passing in 9 this Congress are'not high. 10 '- I'think we're in agreement more than we J
,11. Ldisagreement, namely that there would be a real benefit to
-l12 . external regulation,'that the licensee needs to be the J13 regulated party, because if DOE or both are the' licensee, 14 then you'll get the worst of all worlds.
15 'So,.there's a lot that we agree on. 16 Unfortunately, it's not going to happen anytime soon. 17 MR. BAILEY: We recognize that, too, I'm afraid. 18: COMh4ISSIONER MERRIFIELD: I would like to explore 19 ~ some of the issues that Commissioner McGaffigan has gone 20 'over in some greater detail, starting.with your 21" recommendations. You've got two, and I would like to deal 22 -with them' separately to the-extent Commissioner McGaffigan 23' hasn't. L24- -First-is that the NRC aggressively seek regulatory
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257 authority-over DOE and its contractor facilities. ANN RILEY & ASSOCIATES, LTD. ,
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21 1 In your_ slides, you quote Energy Secretary Bill
'2 Richardson, in a letter that he sent to Representative Ron 3 Packard on February 29th of this year, and in it, you quote 4 him as saying "Many of the potential benefits that we 5 expected to see from external regulation have not been 6 demonstrated and appear to be outweighed by associated costs 7 and difficulties raised in the pilot projects," unquote.
8 I think we, as an agency, have been relatively 9 robust in our defense of the activities that we undertook in 10 the course of this pilot project. 11 We disagree fervently with those very 12 characterizations of Secretary Richardson. 13 We believe, and certainly I believe, that -- well, 14 I should say I believe. I, perhaps, shouldn't speak for the 15 Commission on.this, but I certainly believe that the 16 activities undertaken by our staff,were, in fact, a 17 value-added benefit, were cost-effective, and led to 18 increased and enhanced safety for the individuals who work 19 at these DOE facilities. 20 The report that we have put out relative to those 21 pilot projects, we believe, demonstrates that the pilots 22 were a success. I 23 Now, I believe that -- as does -- as Commissioner l 24 McGaffigan has pointed out -- that we have a good role to 25 play in external regulation of DOE facilities, and indeed, I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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-believe that? the workers at: those facilities deserve to have
~
IL 2 an external 1 regulator.to ensure that.they have the
'3' appropriate levels of; health and safety! protection'as they
'4' igo about their-jobs.
5, Certainly, the individuals who live around those
~6 plants, the stakeholders and the states, also deserve
- 7 assurances.that.those facilities are managed in an 8 appropriate-fashion, and I think, in my own respect, I'think (9 externalfregulation could be an important enhancement of j 10! that program.
11- My question is -- you know, we have been very J12 active in making our views known on' Capitol Hill. I know 13- we've testified-before'atLleast,four House and Senate
'14 committees during the course of 1999-and alluded to this in 16- our testimony.
16 To what' extent have the views of the Organization 17 ofLAgreement States been carried to Congress, and to what 18 extent have you met, either individually or collectively, 19 withimembers of your various state delegations to provide 20 'them the. assurances that this is, indeed, the right 21 direction to go? 22- MR. BAILEY: I think you've hit an Achilles heel 23 there. 24- Fortunately.or unfortunately, I think you will 25 find:that most of the agreement state programs are not h ANN RILEY'& ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 1 (202) 842-0034
23 1 encouraged to directly contact their congressman by their 2 administrations in the state, and often, all of those 3 contacts go through someone far above us in government. 4 It is certainly a weakness, in my opinion, of the 5 agreement state program in that we don't have that 6 flexibility. 7 I think the direct answer to your question is that 8 very few people have actually contacted their congressional 9 delegation. 10 I will say that I was talking to one of our 11 senators' offices on Monday on another issue, and it came up 12 that I was going to be in Washington and we were going to be 13 before the Commission, and the staffer asked, well, what are 14 the topics, and she said would you mind giving me a call? 15 Well, I can respond in that way, when I get a 16 direct request from a U.S. senator, I can call them back and 17 say, well, we met with the NRC Commissioners and it was a 18 very fine meeting and we brought up the issues that we I 19 discussed and I think that they agree with us on some 20 things, but you know, I don't know, and if you've got any 21 magic words for me to'say to them, I'd be happy to take 22 them. 23 CHAIRMAN DICUS: If I could follow up on your i 24 question, and then I'll come back to you if we can, but you 25 mentioned -- and I understand the problem, because I've been ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 6t'.-0034 L
24 1 'in the same situation, but you mentioned that you try to 2 elevate these issues to,the senior management at the 3 department level that can go, presumably, to the delegation 4 of the state. 5 To what extent do you have information or data 6 that shows, when that is dene, something did happen to it, 7 'or do we not know -- do you not know, when you've tried to 8 elevate these issues, that they have, in fact, been carried 9 forward for you? 10 MR. BAILEY: I would say it is mixed. Sometimes 11 we get some feedback, yes, that there has been a letter 12 sent. 13 Normally what will happen in our process, at 14 least, is we'will prepare a letter for whomever's signature, 15 whether it be the department head, the agency head, the 16 governor's office, or whatever, and quite often, the 17 feedback we will get will simply be a signed copy of that 18 letter or things go into limbo and you have people call up 19 and see where is it, where is it, where is it? 20 COMMISSIONER McGAFFIGAN: When I was a former 21 staffer -- I spent 14 years on the Hill, and I nad wide 22 contacts in New Mexico, and I told anybody in your situation j 23 that they should presume that I called them. 1 1 24 [ Laughter.) 25 COMMISSIONER MERRIFIELD: I had the same standing , ANN RILEY F ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1 I
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.25 1- observation with my home state of New Hampshire.
2 Perhaps you may want to volunteer that, if asked, 3 you do have an opinion on it, and.that may bring some of 4 that forth. 5 On the first item, I'd just close with a notion. 6- When we testified before the House Science Committee, which 7 is more supportive, I'believe, of external regulation, we 8 were there with DOE and with OSHA testifying. There was not 9 a state view there. 10 I think it would have helped to further flesh out 11 that opinion, and to the extent you can work with 12 individuals in organizations and in other states to perhaps 13 increase that, I think it would be helpful. 14 MR. BAILEY: Could I just add one thing to that? 15 We've expressed -- or I've expressed what I 16 believe the states feel abcat external regulation, that we 17 should be involved in it. 18 I think, even if we can't be involved in it, we 19 still very strongly support external regulation of DOE and 20 would support that NRC preferably would be the organization 21 to do that. , 22 COMMISSIONER MERRIFIELD: Just briefly, I want to 23 got to the second point, because I know the Chairman wants 24 to move on, and that is that the NRC include in the 25 regulation DOE contractor-operated facilities in the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
26 1 agreement state program, your disappoin'tment. I guess 2 there's two levels of issue here. 3 One is, under the Atomic Energy Act, under Section 4 274, basically we can only give away those authorities for 5 which we have. So, we'can't very well give the authority to i 6 you which we don't have. 7 So, the first thing we need to do is get the 8 authority and then consider perhaps the appropriateness of l 9 delegating that to the individual agreement states. i 10 The second issue in that is, though, as you well 11 know, the Naiver of Federal sovereign immunity as it relate: 12 to DOE and DOD facilities is a very sensitive and relatively 13 contentious issue up on Capitol Hill. 14 I used to be the lead Senate staffer on Superfund 1 15 issues, where we had to grapple wi.h that in the sense of 16 our committee. There was great disagreement, and it crossed 17 party lines, it crossed a variety of spectra. 18 This is one, I thing, we, too, as an independent 19 agency, have to 1:rudge very carefully given the fact that 20 there is that level of disunity of a common position of 21 Congress. 22 So, while you have a huge disappointment, I think 23 it would be not in the best interests of this agency to 24 necessarily be in the forefront of waiving Federal sovereign 25 immunity, since there doesn't seem to be a great deal of
'I l
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' 1' ' agreement.among that, or consensus, I should say, in 2' Congress.
3 Soi .I sort of leave that. 4- COMMISSIONER McGAFFIGAN: There is one last 5 thought I have on this subject, again-to try to keep us 6' focused on the> main thing, if it ever is going to happen, 7- which is txi try: o get external regulation with the licensee 8 being the person who is the -- you know, the contractor-9 being the licensee, and that's that you mentioned earlier 10 these other models and you mentioned some in the materials 11 space. 12 We have similar models in reactor space where 131 something is worked out with the state. We regulate the 14 gaseous diffusion plants, but the states obviously can come 15- in under an MOU and do certain things. 16 With the State of Illinois, at Zion, we just 17 approved an amendment to an MOU that will allow them to be 18 involved in the decommissioning -- not decommissioning -- 19 watching that facility over an extended period of time while , 20: it's in safe-store, and so, there are things that -- if we 21 could get the main thing done, as Commissioner Merrifield 22- suggests, there are. things short of dealing with sovereign
-23 immunity that would-give you a role, and.I think we could 24 work those things out.
12 5 CHAIRMAN DICUS: Mr. Marshall, do you want to ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036-(202) 842-0034
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~1' -continue?'
2 MR. MARSHALL: I'd like to move next to Rich
~3 Patliff with the topic " Source Material Exemptions ~."
4 MR..RATLIFF: Good morning, Commissioners.
.5 This~is one of the topics, I think, that impacts ;
6 .many of the states, and I want to go through some of the l l 7 initiating events of what we're seeing on source material. l 8 . exemptions. 9 The first slide, please. 10 You have the bullet where it says " Shipment of 11 waste containing source material to unlicensed facilities," 12 and I want to clarify that. 13 What we have done for years -- I've beCn'in 28 14 . years now working on these rules, working with the NRC, 15 'through the State of Texas - 'I'm with the Texas Department 16 of Health Bureau of Radiation Control, and we always looked 17 at 10 CFR 40 and-would ask the question of staff, when it's 18 exempt,;does that mean it's exempt.for disposal,. and we l 19- :always got the answer no.
' 20' So, when material from FUSRAP sites went to 21 ' California, we felt that -- that kind of brought the issue f l
I 22- to a head'. It went to a landfill, really not a licensed 23 site, and then,.as the Commission, you've reviewed the
-24 policy and have confirmed that, yes, if it's exempt, 25 concentrations exempt by the 10 CFR 40, it's totally exempt.
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l 29 1 COMMISSIONER DIAZ: Madam Chairman? 2 , CHAIRMAN DICUS: Commissioner Diaz? l 3 ; ' COMMISSIONER DIAZ: Can you hear me now? l
.4 CHAIRMAN DICUS: Yes, I can hear you now.
5 COMMISSIONER DIAZ: The reason I was so quiet is 6 because you couldn't hear me before. It's not that I did 7 not haveJ. questions, j 8 CHAIRMAN DICUS: Okay. Did you have any questions l 9 -with regard-to the DOE oversight? 10 Commissioner.Diaz, we're not being able to hear j 11 you-very well, you're breaking up. So, we'll have to 12~ re-look at what the problem is so that we can you on the 13 bridge, and I think that's.the feedback that we're getting, 14 as well. 15' Why~ don't you continve? I '16 MR. RATLIFF: The fact that the NRC clarified that 17 especially the source material that's less than .05 percent [ -18 by weight-was exempt really brought a new regulatory area L R19 that the states had to look at, because as you know, the 20 formally utilized sites were determined not to be under-NRC jurisdiction, and now the material really was exempt from 22 other sites, and.so, we've really. looked at this a lot, and i 23 . when we get down-to the point of look~ng at exempt l 24 concentrations versus release for unrestricted use and some 25 of the comments I'll have at the end are some of the ll ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
30 1 suggestions we have, because when we look at~ the different 2 levels of uranium and other products:that really aren't 3 addressed'that come'in from the exempt concentration or 4, exempt levels, if'it's exempt and it goes to a sandbox at a 5~ day-care center, I have a lot more concerns than I do if it
- 6) goes to a hazardous waste or a regular 11ndfill, and so, I
.7 .think'that there's some tweaking that really needs to be
~8. done when this rule is reviewed, 9 The' Colorado program then found a company that was 10 not under the exempt part, but they were a general. licensee, 11 and under'the general license in 10 CFR 40.22(b), the
'12 facility was exempt from a-lot of things, including the 13 worker protection, contamination control, and so, they ended 14 up.with a facility that would not be released under the
.15 state's criteria nor the NRC. criteria, but yet, because they 16 were' exempt, they really were able to do this operation and 17 really cause radiation areas that were much higher,'so we
'18 get back to the same thing, a rem is a rem is a rem, really 19- didn't work here.
20 Then, in specific, the next slide, on 10 CFR 21 113 ( a ) , this is one that -- NRC, I think, started to really 22' 'look at'this in 1992, the 57 FR 48.749. .You all proposed to 23 totally re-look at the 10 CFR 40. You know, it's been since 241 the. Atomic Energy Commission, I think, created in 1946, and
.25 :this was set up1 in 1947 but not based on any radiation ANN RILEY & ASSOCIATES, LTD.
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1 safety criteria but based on the strategic use of the 2 materials, and now that you have real specific l l 3 deconomissioning standards, as agreement states we're 4 adopting these standards.
-5 When we look at the radiation concentrations and j 6 .the ensuing radiation levels that people could be exposed l 7 .to, they're not consistent from the standards to what the i
8 exemptions are in the rule. ; 9 When you look at the exemption, it's less .05 ! 10 percent by weight, and you go to the next slide, for 11 uranium, just natural uranium, you're looking at 330 12 pico-curies per gram, for thorium, 116, versus what you and 13 what we require as agreement states, cleanup Jor uranium i 14 sites'of 30. I 15 There's a wide difference there. 16 The thing that we really look at in the states is 17 the fact that you do have the daughter products in any of i 18 these, and the radium tends to be one of the more hazardous 19 materials. . . l 20- In fact, work that I did on the Conference of 21 Radiation Control, working on low-level waste, using NRC's
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[ 22 models, radium was equal to or greater hazard than l 23 plutonium, because it's a long half-life, it's a 24 bone-seeker, it's a alpha-beta-gamma emitter, you have radon ( 25 gas produced. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
32 1 So, .adium tends to be one of the materials that 2 can really~cause multiple real hazards to people. ) { 3' So, what we're recommending is that 10 CFR 40, I ) 4 think, is going to.be reviewed, but it's been a long time 5 .- since'this, started, and it really needs to be reviewed with 6; L your current dose methodologies, your current biological 7 -data,'and to really 90 through and look at what is safe, 8 .becausefyou'really, I don't think, want to have exemptions 9 like you have now, with the source material less than .05 10 percent by. weight is exempt, because it's exempt and it 11 could go'to sandbox in a day-care center. 12 I don't think that will happen, but it's possible, 13 'whereas controlled disposal'really would be what I would 14 suggest when we get into the amendment, because you could 15 have a two-stage exemption, exemptions that really are
- 16. exempt, totally exempt.
17 For' instance, the smoke detectors with americium ~ 18 sources =-- they're exempt, you put the::L in the landfill, 19 there's no hazard. 20 Even if they end up somewhere, they're just not a
.21- tszard, whereas.those concentrations of. uranium and thorium ,
- 22. ;really are not' appropriate to be released to put in 23 someone's-backyard as fill dirt or whatever.
'24' So, I think there's a two-pronged approach that 25 could be used as stuff that's truly exempt and stuff that's ANN RILEY & ASSOCIATES, LTD.
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33 s 1 exempt from being disposed of as radioactive waste but that
'2 could go to equivalent disposal.
3 Then that whole part'gets to be one of the parts 4- Ethat - .you'can see I have pulled a lot of my hair out over 5 the' years about it, because after the Juarez incident back 6 in the '80s,~most'of.our scrap-yards and our landfills have t 7 radiation detectors, and so,.they detect multiple things. 8 I would say more than half of it is naturally 9 occurring radioactive. material, a lot of patient diapers 10 from medical treatments, but aircraft engine parts come in, 11 'and.it gets.real confusing with the way the rule is set now, 12 because if'it's a complete engine, it's not been worked on, 13 it doesn't have any milling or grinding, it can go into the 14 landfill as an exemption, but if it's a part.that's less 15 radiation,:it can't go in there, and so, this whole part 16- confuses,the people who have the aircraft engines, it 17 confuses the regulators, and in general, everybody, and I 18 think, when you do the reviews to this section, it really 19 needs to look at something that will be useful, given the 20 circumstances today, that you have a lot of material 21: recycled, either at the' steel mills or material disposed of 22 at the scrap-yards'or you do have detectors, so that you 23 really look at.the radiation safety as the bottom,. that if
.24 .it's safe'it can go there, if not.it should not be disposed
' 2 5- o'f in'that manner.
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'34 1 Then my final slide ~here is, looking at the whole 2 issue'that'we' deal 1with, and I think Ed's touched on it and 3 -others will, is NORM, the naturally occurring radioactive 4 materials.
J5. We have many of-the~same isotopes, you.have tne 6 same_ problem, .and it's really not an NRC' problem, it's the
'7 Congress'1 definition oftwhat.you have_ regulatory authority 8 over.
9 ' A nunter of -years ago, the states had worked with 10 NRC to really have. control over NORM, and there were studies 11 that were done, but I think the final word came down that 12' really, no , it was.a states-issue and NRC didn't have 13' resources.
' 14 - ~But I think to have -- what we've always talked 15- about-is a uniform regulatory program across the United 16 States, which we. feel the agreement states have, that.NRC 17 -really has to regulatefthese other materials, the NORM, the 18 Laccelerator-produced materials, and I think it's a big leap
- 19 to get=to the-machine-produced, the x-rays and accelerators, i20 but theLideal situation.would be.that, but just regulating 21 radioactive. materials would really, really help.
22 .The FUSRAP issue -- just to touch on it, you know, 23 Lit's something that was forgotten,'now it's come up, it's 24 ' shifted around, but as states, we're dealing with it daily. 25 We spand a. lot of resources on it, but we feel ANN RILEY & ASSOCIATES, LTD. Court Reporters-1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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7-35 1 .that, with the exemption, if.it's for disposal only, we have 2 -disposal sites that we feel. comfortable with that can go 3 -there.
- 4 The ones that we are,looking at in Texas are both 5 ' hazardous waste' sites, so even iffit'did become a RCRA issue 6 in the: future, they're already in hazardous waste Lites, but 7- I .think clarification on that: whole rule to make sure that i 8 those -things can cya there without any problem, because-we 9- devote a lot'of' resource to that, and I: think, in the 10 future, as you make changes to this. rule, we would really be 11 willing to come to the table, devote our resources to l 12 develop a rule that's1 workable for all of us.
l 13 CHAIRMAN DICUS: Thank you. I appreciate your 14 comments on that, and I know that the Part 40 rule-making is 15 lagging a' bit. In fact, it's probably been put on hold 16 aecause of' competing' priorities that we have and the
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17- resource issue that you mentioned. 18 We recognize, for several of these issues, there 19 are a lot'of concerns with both technical issues as well as i '20 jurisdictional issues, and we have the staff working on some 21~ ideas on how we're going to deal with some of these, and I 221 -think we expect a paper to us next month on some of those
- 23. issues.
24 FUSRAP is clearly our most frustrating issue, to 25' me,.I think to all of us, and we look at it just frotn the > l p ANN-RILEY & ASSOCIATES, LTD. Court Reporters 1025. Connecticut Avenue, NW, Suite 1014
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.1 'legalipoint of; view that we have to deal with and then 2 looking at it.from-a scientific point of view, the two don't
.: -- they pass in'the night and-they don't quite meet,;but
'43 'that'sljust part=of the fun that we have in our various
'5 . programs and: dealing with some of.the. issues that we must
- 62 deal'with.
7- -Commissioner Merrifield, did you have any comments 8' -you wanted.to'make? 3 COMMISSIONER MERRIFIELD: The first one is sort of 10' a ciarifying question. You mentioned the notion of these 11- materials ---it1was determined they need to disposed of, 12 .could go to equivalent disposal facilities. Did you mean 13' ' RCRA sub-title C facilities?
- 14. MR. R,1TLIFF : If it has hazardous materials, then 15 'I think itLcould=go.to.a hazardous waste site. If it was 16 fjust. contaminated dirt.with no hazardous constituent, it 17 'could-go to just a regular permitted landfill.
^ 18 So., I think, you know, it really depends on the 19 'other constituent, whether it has a hazardous constituent, 20 but:I think, at that exempt level', I have no problem, from 21 the health and safety risk, that it goes tr. those sites.
22T I think it's better -- that way, at least, it's 23 put'into a facility that's monitored, secured, and you don't q 24 .have it< appear in'different places in the environment 12 5 COMMISSIONER MERRIFIELD: Okay. So, you're ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
- n. n 37 1 -comfortable with subtitle D facilities.
p E L3 MR. RATLIFF: . Correct. 3 COMMISSIONER MERRIFIELD: For materials that have 4 hazardous components,. subtitle C, and for that which is not 15 exempt, it.would go'to' Enviro-Care or one of-the other L 6 facilities-permitted'to take low-level waste. 7 MR. RATLIFF: Yes. l 8 ' COMMISSIONER MERRIFIELD: All right.
?9' .You talked a-lot about the need for consistency in I 10 a: regulatory approach. Although it wasn't part of your.
_-1 11 presentation, I do want to explore one issue. 12 Currently underway at the agency is an edfort we 13' .have to seek stakeholder input on how or if we should move 14- forward cx1 a clearance rule, .r.nd I was wondering, given the
'15 ' issue of consistency, is there a position among your group-16 on that' issue that you'd like to share with us, and is that
'17 . consistent among you all?
18 MR. RATLIFF: I think the answer is we've 19- discussed it, and the majority, I think, agree. We need a l 20 floor that,-below this level,'it can be handled not as 21 radioactive material. l 22 Without that, you're continually having to go.into 23 different'modeling,' different approaches from state to 24 state. L25 I think it also helps the-people that we both ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 ,
30 ) l 1- regulate if they know that this is -- anything abcVe this is 2 going to be disposed of as radioactive waste or raciractive i I 3 material. I 4 It gives them the up-front foresight to know how I l 5 they have to conduct their operations and help them conduct l I 6 them in a better way. The exemptions like this -- I think .j i 7 -you run into so much opposition. ) 8- What we had, though, in Texas was successful. We 9 . were petitioned for rule-making to take radioactive 10 materials with a half-life less than 300 days to go to a 11 landfill, and we had certain concentrations. 12 It was not only supported by our board of health 13 and our boards and the regulated community, but "he Sierra 14 Club supported this rule-making, because it really saved 15 money for the universities, for materials that could go to a 16 landfill under controlled situations and not have to go as 17 low-level waste and therefore leave them money they needed 18 for doing other educational issues. 19 So, I think there's a lot of different things out 20 there that we can work on to make this issue work, and I l l 21 really think that the'whole clearance regulatory issue is an ! 22 important one to all of us. 23 COMMISSIONER MERRIFIELD: Just by of clarifying, 24 you mentioned that a majority of members were supportive of 25 this. I wouldn't want to have you point out which states i l J ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
39 L 1- 'weren't, but isLthere some attempt to come to a consensus 2- l view-that could'be represented as a view of OAS?
'3- MR. RATLIFF: Well, we haven't voted on it, is the L14 : thing. We've discussed it a lot, and I think that's what we
;5 need to doi _
6 ~I think that's an issue that's definitely one.that
' l7' 1we'll ?. lave'to address and that Ed, as Chairman next year --
8 Lit will.be a challenge to really get everybody'on-board, but' 9 'there are a few people that'still don't think that you need
' 10 - to have a level like'that, but most of us who have worked 11 withius and seen-the realities agree, you really do need a 12 clearance rule, a below regulatory. concern, whatever you
. 13 want to call it, something that really establishes the lower
- 14 limit that really causes no health concerns to the public.
. 15 MR. MARSHALL: I would suggest there's probably 16; not a significant opposing opinion,- that many states without 17 l resources or'the circumstancec to'need to address it will
'18 _probably be in favor,'but as Richard says, we've not voted 19' with-a' formal -- for a formal record on it.
20 MR. BAILEY: .I was at:the San Francisco public 21 meeting, and ILthink there are a couple of things that
-1 22 struck me'at that dieeting.
23- One is thatLsomehow we got it over into recycle,
. 2 4' andithat raise 1 concerns among environmentalists, consumer l25 ' groups, Land so forth.
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40 1 In listening to representatives from the 2- individual power plants, from the steel industry, and so 3 forth, they were hoping the rule wasn't going to be used as 4 a recycling rule; rather, that it was going to be sold as a 5 disposal rule, and I think if it were repackaged and ; 1 6 . presented in.that fashion, rather than, as it got turned 7 around to, a' recycling issue, that it would be a much easier 8 sell. 9 I didn't see any of those groups, other than some 10 of their organizations, saying, hey, we want this, we want 11 this rule so we can recycle more of that stuff. The steel 12 people didn't want it. The power plants said I don't want 13 me steel going and being recycled. 14 So-those were sort of my takes on that particular 15 meeting, and I did have to add at that meeting, since I was 16 there in California, that both members of the legislative 17 and executive branches of California government really have 18 expressed concern about this rule and whether or not it 19 would be an item of compatibility, strict compatibility, and 20 if it weren't, then would we have shopping around? Could I 21 take my stuff to Nevada or Texas and get it recycled if I 22 couldn't in California? 23 So, there are all these kinds of issues. 24 COMMISSIONER MERRIFIELD: This reminds me, 25 whenever I used to have discussions with the state, I would ANN RILEY & ASSOCIATES, LTD, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
41 1 always refer-tohthe-state of' Aurora, so you never had to
.2 refer to.any particularistate.
.3 1So,,let me just get your-last point, so it's. clear 14- to me,7at i least.
15 'What you're'saying is you think the idea of our 6E having aibaseline standard so that there-isn't. shopping by _ l 1 7 somelof these' folks >is a positive thing. 'That was the
. 8 ' impression.
9' MR. BAILEY: Yes, I do, and we did -- I think,
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'10 during that meeting,'did suggest that you have a table -
I 11 similar to what you do for water.and air, rather than having l 12 -all this dose modeling,.which anybody that's worth their ]
'13 salt as a dose-modeler can change it by at-least one order 1 14' of magnitude in'the process. So,'give us a table, you 115- measure it, if it's below it you throw-it away or dispose of.
16'- it"however it s1.ould be. 17 CHAIRMAN.DICUS: Okay.
,18 Do we have Commissioner Diaz~on-line?'
19 COMMISSIONER DIAZ: I am on-line. 20 CHAIRMAN DICUS: Can we' turn up the volume, 21 because we can barely' hear you, t
- 22 COMMISSIONER DIAZ: :Can you hear me now?
L .2 3 ' CHAIRMAN DICUS: Barely. L 24' COMMISSIONER DIAZ: I guess-this is not working. 25: ' So, I'11.just listen a'nd-be. quiet. l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
~ (202)' 842-0034 l 1
I 1 1
42 1 CHAIRMAN DICUS: 'I apologize, Commissioner Diaz.
=2. I think our technology is a little behind the times right 3' Ihere, so we.need to keep working on that, but at least.you 4 'can hear us, so that part is good, and I'm sure, if you have l5 _any particular questions, if you'd like to submit them in 6 ' writing, I:think wefcan probably get_them address.
7- Commissioner McGaffigan. 8 COMMISSIONER McGAFFIGANi I will.get off the 9 clearance for_the moment land get back to the Part 40 issues i 10- that you have raised with us. 11 The first comment.I would make is that the Staff' 12: :has not been consistent ~over the years.with regard to exempt i3 materials'and whether they could be disposed of. We went 14 and looked at the history of that last year. 15 The second point I would make is that in the case 16 of the Metcoa material that ended up at WCS, the state 17- regulator in Texas for RCRA had previously allowed some
~
l 118 .FUSRAP material.from another state which they had declared 19, exempt NORM, almost identical stuff, to go to WCS. That was 20 a factor and it was not going to a school sandlot. It was
~ 21. going to a hazardous waste facility. It was all those sorts 22 ofLthings that weighed in our mind in making that decision.
23 I agree that we need to look at Part 40. I think
- 24 one:of1the issues -- I hope it.is not forever on hold. We
-(
25 .have'three papers before us at the moment that need to be
- ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue,_NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 o_
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's .
43 1 voted on once_we get some additional information and 2' additional thingsineed to be looked at. 3 One of the problems we face in all honesty.in this L 4 ' area is we have got a very small number of licensees and l
-.5 under the fee-legislation they get weighed'down with L 6 everything. At-the_ moment they get weighed down with a lot of adjudicatory matters which hopefully rules would help 8 -straighten out so that there~would be less adjudication, but 9' this may be an. area where some day somebody in the Congress 10 who really'wants us to legislate in this area is going to 11 have'to give us some money off the fee base to revitalize 12 Part 40 and get it done and-get the resources for it, 13 because we will bankrupt the few remaining people who are 14 -trying be prepared to mine uranium if we make this too large 15 a process, and yet it needs to'be done.
!. 16 The' issue I would like to explore is NORM, because 17 you guys have been saying, both of you, a rem is a rem is a 18 rem, and one of the_ perplexing things for me still learning 19 .this business is the way that NORM gets handled -- you know, 20 the CRCPD had some draft rules on NORM'and you got the usual 21 letter from EPA saying it was' inconsistent with Superfund 22 principles, blah-blah-blah -- that we.get, that DOE gets 23- that anybody who tries to make rational regulations gets,. 24 but what: you were trying to do there was consistent with 25 your current practices,~as I understand it, with regard to ANN RILEY & ASSOCIATES,.LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 . I (202) 842-0034
44 l' -NORM'.
- 2 Could you tell me a little bit -- Mr. Bailey 3 should1 feel: free to. talk -- you know,.one of the perplexing 4' things..is the famous Buttonwillow case. That facility for
- 15. ?better or worse is: regulated and presumed safe by I guess a 6 different; state of1 California regulator to receive NORM 7 ' materials from the nearby oil fields, the slag and whatever, 8- up to 2,000.picocuries'per gram, as-I understood it, and'
'9 .that is what.the_ Corps has been'sayingland yet stuff that is 10; "f'ar:less contaminated coming;in from'New York-the state has lli a problem.with and how often are these RCRA facilities 12 allowed to take fairly significantly_ contaminated materials
'13 'from oil fields or whatever? 14- MR.'RATLIFF: In Texas, where we have a lot of oil 15 drilling and reworking of wells, we have real specific rules,.and-the 2,000 picocurie per gram is a Department of 17 LTransportation rule for their purposes. -If it is below that 181 ,it wasn't regulated-forLtransportation purposes. 19: il think somehow EPA got this transferred to some 2(F of the states'-hazardous waste groups and they_put this in 1 21 permits'and that is not an. appropriate number. In Texas we l 1 22 cet up our numbers based on.two things for;a oil and gas 23 .related scale lthat'has' NORM,-but we went with the limit for 24 -uranium mill l tailings for radium, which is 5 picocuries per 25? . gram unless they-could show that the radon emanation was ANN RILEY & ASSOCIATES, LTD. CourtJReporters 11025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034' l
45 1 less than the 20 picocuries per square meter per second, 2 which is the real controlling factor EPA had on looking at 3 the dose, and if it is less than that they can go to 30, so l l 4 l radium ends up being the controlling factor, then other l
'S isotopes you have in NORM the uraniums, the thoriums, other 6- daughter products. We have gone to the .05 percent by 7 weight exemption and extracted that and just came across the 8 board for 150 picocuries per gram.
9 It has worked well for oil and gas, but the unique 10 thing with oil and gas though in Texas is that it is 11 regulated by us and our Railroad Commission of Texas and ; 12 they are allowed to take -- there is a license that we have l l 13 with two companies and they permit these companies where ' 14 they put it back where it came from. l 15 The have deep injection wells and so you don't end l l 16 'up'with a disposal problem for oil and gas NORM. Other NORM 17 is.a different situation. There really is no disposal site 18 to handle that NORM. I think it has to be based on risk and 19 that is what we have done in our rules, and we have looked 20 at what equivalent rules do we have'for uranium industry and 21 for other areas. 22 CHAIRMAN'DICUS: Yes. I i 23 COMMISSIONER MERRIFIELD: Can I just interrupt 24 because this is a very good piece I want to ask a question 25 to clarify. You said the EPA adopted the DOT rules relative i i ANN RILEY & ASSOCIATES, LTD. j Court Reporters j 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 ! (202) 842-0034
46 1 to the 2,000 picocuries per gram -- l l 2 MR. RATLIFF: I don't know if they adopted it. I j 3 think they presented it that it was a number out there, and l 4 I am not sure how the states got it but it seems that there 5 are multiple state hazardous waste regulatory agencies in 6 states that have come up with that magic number and really 7 they are using it inappropriately. 8 COMMISSIONER MERRIFIELD: But that number 9 apparently went through EPA, do you believe? I am just 10- guessing because they are EPA delegated programs. 11 COMMISSIONER McGAFFIGAN: And I think this is a 12 discussion that I think some day we need to have in much 13 greater depth, but the other place -- 14 CHAIRMAN DIFITS: So are you suggesting we have a 15 NORM briefing? 16 COMMISSIONER McGAFFIGAN: Well, some day we need 17 to have it, although that is not our area. 18 CHAIRMAN DICUS: It might be some day though. 19 COMMISSIONER McGAFFIGAN: A rem is a rem is a rem. 20 COMMISSIONER MERRIFIELD: I was going to also 21 suggest that there is some possibility at least, although I 22 wouldn't want to unfairly characterize our r.rethren at the 23 EPA that we may be suggesting levels that are more 24 protective of health and safety than they are. 25 (Laughter.] ANN RILEV & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
s. 47 1 COMMISSIONER McGAFFIGAN: Well, certainly our 2 Agreement State colleagues are, ,
~ l 3 MR ' BAILEY: I think they would disavow any I
?L knowledge of that number.
;5 COMMISSIONER MERRIFIELD: That is why we don't 6 want ' to make zul unf air characterization.
7 COMMISSIONER McGAFFIGAN: But just to stay on this 8 subject, I mean again something that was motivating us when I
.9 we were, thinking about what the right thing to do is-here, I 10' fand Mr. Paperiello is sitting there behind you, but coal 11 ash, which .:Us probably the single largest amount of 12 -technologically enhanced NORM we have out there, as I l 13 understand it EPA encourages the recycler of coal ash in 14 concrete.for building materials, et cetera. ,
i 15 You mentioned your state legislators are concerned 16 about things. LWell,.sor.s of that coal' ash can be 500 parts 117: per million uranium and thorium, right? -- or higher. It- i 18' can be' fairly hot' and'it it-were controlled by.us it would 19 be in'this. mix. I don't know what the effect of recycling 20 the: coal ash in building materials and concrete is but if it 21' is fairly.' hot coal ash it is trivial compared to all the 22J granite on: Capitol Hill-probably but there's some dose that 23- probably would lxa higher:than any dose you would get from 24 any recycled nickel coming out of Mike Mobley's contractor ;
-25 'in Tennessee by'many orders of magnitude.
4
' ANN RILEY:& ASSOCIATES, LTD.
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48 l n I think the reason sometimes it gets
.1 MR. RATLIFF:
2 blessed is because it is= natural. It has been here. It is-3 extracted.and what we'see with'the coal ash is that it can L4 be-high. Typically it.is' lower but it is still being put ) 5 into building materials and if I remember right, there is. 63 still:aLrequirement'that' federal new buildings'use this for 7 recycling-purposes, j EF , The studies we have done have looked at the radon 9~ emanation, which is-because' radon would be the greatest 10 problem --- 11: -COMMISSIONER McGAFFIGAN: Right. 12 .. MR. RATLIFF: -- and there'is just not a radon 13 problem, but yet it is still material going there for 14 inappropriate use and we concur with that. 15' ~ COMMISSIONER McGAFFIGAN: .I don't know whether it l'6 is inappr'opriate or appropriate. EIt is just the practices, 17 the actual practices that we have going on across the 18 . nation, and your viewgraphs were to the point that the 19 practices don't add up.to a coherent whole, the practices 20 don't add up to a coherent whole and it is not just our' l J 21 -fault.and it is not yo'ur fault. ) l
- 22. CHAIRMAN DICUS: It is a combination.
'23 COMMISSIONER McGAFFIGAN: It is EPA has to take 24- 'some responsibility as well. Why don't I leave it at that.
4 25 CHAIRMAN DICUS: All right. Mr. Marshall is
)
i ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1025. Connecticut Avenue,-NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
a E 49 1 . ready. We can proceed to the next topic, and I am kind of 2 ,looking at the watch. We still have a lot of material to 3 cover,.so try to move us.along. 4 MR. MARSHALL: I am watching it as well and I will 5- .just ask. David and Roland to bear that in mind as we
- 6" still'--
7 CHAIRMAN DICUS: Thank you. 8' MR. MARSHALL: -- have Bob -- David Walter from 9 Alabama'on. comparisons of Part 35 and Part G. 10 MR. WALTER: And you-might say I am here as 11- Agreement State but I am also here as the CRCPD since 12 virtually.everything_that I am going to talk about has to do 13 with'the Conference's SR-6 committee. 14 I would like to take a few minutes to inform you 15 'about areas of the-revised Part 35 for the Agreement States 16- and the Conference's use of-radioactive materials or the 17 SR-6 committee have some differences of opinion, but I also 18 want to give.you my opinion on how the parallel rulemaking 19 processes work for Part 35.
'20 Let me start with the second slide with the duties of the authorized user. At the public hearing conducted at
-22' 1the '98 Organization of Agreement States Meeting a number of-l
'23 = states-commented that the specific duties of the authorized L
24 users should be detailed in-the rules. Well, currently the
-25 definition of an authorized user includes reference to their ANN RILEY & ASSOCIATES, LTD.
Court Reporters
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- 4 0
.50 J1- required training and experience. The only, time that'a
- 2; specific duty:is spelled out for.an authorized user is in 3 35.40 where'it'says that-the authorized user,must prepare a 4 written directive.
5' 'If.you look1at 35.27;it says the licensee shall 16 requirefa. supervised. individual to follow the instructions 7 of a supervisinglauthorized user, but there is no reference 8 -to the-duties of that supervising-autnorized user and 35.27' 9- further refers you'to Rule.35.11;- but when you :look at 35.11 10- itostates'that:an' individual may; perform license duties-11 -under the-supervision.of an authorized user as provided in
- 12. 35.27,.and that.' appears to be a Catch-22. -
13- .Our committee believes the rules should be a 14 'little bit more specific regarding the duties of all'the
- '15 -authorized' users. It is our intent to offer rule text that 161 ' specifies.the radiation. safety related' duties of the 17' ' authorized user based on the-radiation risk of the-study.
18 .These will be broken into three' specific 19 requirements that may sound very familiar to many of you -- 20 selecting the patient, prescribing the dose or dosage, and 21- . interpreting the results of the study. The reason it may 22- sound' familiar ~is.because this text is similar to that that
- 23. 'was usedl in the mid-1980s Reg Guide 10.8.
'24 -Now there will be-those out-there who say it is 25 'the practice of medicine and we have to stay out of it, and ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025: Connecticut Avenue, NW, Suite 1014 Washington, D-.C. 20036 (202) 842-0034
,o , , .
51
,1 I'say to them that that is true. It is-the practice of
,y(2 . medicine. But it is also dealing with radiation safety of 3- the patient and that is our job, and you simply just can't 4 ' separate those:two. Next slide.
5- Next I want to discuss the submission of written
- 6. procedures. Throughout the new Part 35 there are a
7 requirements to develop and implement. written procedures. 8! .However, there is no requirement that the licensee submit 9- lthese procedures for review by the Commission Staff. Rather 10 the intent is to review these written procedures only when a
'll problem is found during an inspection that should have been 12 - addressed by one of these required procedures.
13 Well, the SR-6 committee intends to have Part.G 14 -recommend the submission of these written procedures for 15 review byLthe' state agency. Thefreason is, simply stated, we 16 would rather determine the adequacy of a written procedure 17 ;before a problem occuir If you want until after a prob.' m 18 occurs you'may: find that the written procedures were totally 19 inadequate, were never even written or that nobody even knew 20 they existed and if:that is the case, that means each p'erson 21= i s l e f t o n t h e i r o w n i'n h a n d l i n g a n y g i v e n s i t u a t i o n a n d 22 ~ .quite likely they are going to handle it in a different way, 23- and I. don't believe that this is in the best radiation 24 safety interest of the patients or occupational workers. 25' Additionally, we also believe that the review and ANN'RILEY &-ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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s , 52 l' discussion of a' written procedure opens a line of 2 communication between the agency and the licensee and can 3 . build a rapport'or at least start building a rapport between i4 them and it can increase the confidence of both parties in 5 the-resultant radiation safety program. Next slide. 6 'Now let me discuss patient release criteria. Rule 7 35.75, or the patient release rule subject, is a very 8 difficult one for us states. On the'one hand you have a 9 ~ possible small increase in exposure to the general public 10 .with a tradeof.f of lower medical costs and better patient 11 morale, but on the other hand you have muddied the radiation 12 safety aspects of unsealed source therapies by placing 13 radiation safety into the hands of a minimally trained
.14 patient,and their family and you may have led to increased 15 costs to state agencies who have no choice but to respond to 11 6 landfill alarms and deal.with resultant waste.
17' There are'some points I would like to discuss
=18 here.
19 First, if a member of the public can receive 5 20 millirems of exposure from a released patient, what is the 21 limiting factor for this exposure? Can this same member of 22 the public -- for instance, an LPN working at a nursing 23 home -- be exposed to numerous released patients resulting 24 tin exposures'muchl greater than 500 millirems in a year? If
.25 so,'then what'is the point of having a 100 millirem per year ANN RILEY &: ASSOCIATES, LTD.
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53 1 limit for the general public? 2 On this point, why not offer the same types of 3 exeraptions to all other dif ferent types of licensees, not 4 just medical? Well, once it is decided that such exposures 5 are acceptable, then your heart of the matter is the 6 training that is given to these patients and their families. 7 Is it adequate and effective? If it is and the patient 8 really understands why and follows through on how tt 9 maintain these exposures to others' ALARA and how to 10 minimize the waste problem, then this rule should work. If 11 'not, we end up with unnecessary doses.to the public and
.12 increase landfill alarms.
13 Judging by the increases in landfill alarms over 14 the last few years, it appears that at least some of the 15 licensees are not providing adequate ALARA training as 16 required. Next slide 17 The revised Part G will offer as an option to the 18 states verbiage that will allow the release of patients but 19_ will try to assure that the ultimate responsibility for 20 radiation safety remains with the licensee. Additional text 21 will be included that requires the authorized user to 22 personally approve the release of the patient based on their 23 professional opinion that the individuals are adequately 24 trained and fully understand how to maintain exposures ALARA 25 and minimize the release of radioactivity. Next slide, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
54 1 please. 2 Now let's turn to authorized user training and 3 experience. In the revised Part 35, there has been an 4 increase in the required total number of hours of training 5 from 800 to 700 hours for uses covered under 35.390. SR-6 6 applauds this increase in training hours because the new 7 Part 35 is supposed to be a more risk-based rule and we 8 believe that the therapeutic use of unsealed radioactive 9 material is about as high a risk as you are going to get in 10 these rules. 11 However, we disagree with the decision to maintain 12 the training and experience for oral I-131 as specified in 13 35.392 and .394 to only 90 didactic hours and three 14 supervised cases. 15 When you compare to other therapies those 16 involving I-131 have proven to be the most likely to have 17 misadministrations, and of all the current unsealed source ) la therapies, oral I-131 poses the greatest radiation risk to 19 ancillary personnel and to the general public. For these 20 reasons the new Part G will recommend not have lesser 21 training requirements for those authorized users who wish to 22 use-only oral I-131 for therapy. The committee will 23 recommend that they be required to have the same 700 hours 24 of training and experience as anyone else who wishes to use 25 unsealed therapeutic radiopharaceuticals. Next slide. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
55 1 One of the things that SR-6 wanted included in the 2 revised Part 35 was a set of minimum training and experience 3 crir- ia for technologists. I mean they are the ones who 4 actually handle the isotopes and dose the patients 95 5 percent of the time but there are no minimum training and 6 experience requirements in the rules. Unfortunately we were 7 unable to get such criteria included in the new rule, so our 8 committee is Joing to try to come up with a set of 9 recommer. dad mi.imum radiation safety -- and I stress 10 rLdiation safety -- training and experience criteria for 11 nuclear medicine and therapy technologists. 12 The committee has already gathered minimum 13 training and experience requirement information from many of 14 the states that already require licensure or registration 15 for technologists and will use that information in drafting 16 our rule text and although this text that we draft will not 17 be as restrictive as many of these current state 18 requirements, there are a number of states out there that 19 have no current requirements, so this could be a good 20 starting point for them. Next slide. 21 Now I want to discuss probably the most l 22' contentious rule in this draft Part 35, to me at least, and 23 that is 35.3047. As anyone on your staff who was at the 24 working group meetings can tell you, I don't agree with this 25 reporting rule at all. Regardless of its intent, I view ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
56
' 1-thisLruletas a'detfacto approval to allow embryo fetuses and 2- . nursing children to receive 50 timen more exposure than the
'3 : rest of the general public and 10 times more exposure than
.4 the allowable limits from a released patient.
Because of the obvious contrary health physi;s I 5' ; I 6' implications the SR-6 committee has decided that the revised ]
.7- Part G'will not recommend the inclusion of such a reporting 8 requirement. We will instead allow our Part 20 equivalent 9 exposure,1-imits and reporting. requirements to take.
10' precedence. Next slide. 11 Now a-few statements about the parallel rulemaking I believe the process 12 process during this Part 35 rewrite. 13 .has worked very well and has been quite helpful to the 1
- 14. states, but for the process to work its best the states 15 'should lxa represented on the rule writing teams. Now the 16 .Part 35 working group included Marsha Howard from Ohio as 17 well as myself, and Tom Hill from the state of Georgia 18L represented the Agreement States on the steering group.
19 This'seemed to-work quite well, and my being on the SR-6
- 20 ' committee helped a great deal.
21 For any major rule revisions or new rule writing I
'22: strongly urge that a member of the Conference SR committee 23 that is affected by the change be included on the NRC
-24 working. group. In addition, the Agreement States should
. ;5 have a representative on the steering group, because having ANN RILEY & ASSOCIATES, LTD.
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.1 these state representatives on these working and steering 2 ' groups has provided for a better line of communication to 3 .the Agreement States. The representatives can' relate
,4 specific areas of concern to the states and let them comment L5- and give suggestions about the rule, and give those back to 6- those' individuals who'can relate them to the working groups 7- in person.
8 I,was also able to give regular updates to my SR 9- committee members and this allowed them to understand the in direction-the NRC rule was taking and tried to start i
- 11. formulating ideas for suggested. state regulations text.
12 Our committee met in February of this year and I l'3 -think we were all very pleasantly surprised at the amount of 14 work that we got down in the amount of time that we had, and 15 I: attribute much of this to the members being informed of
~
16 what the NRC drafts were so that we'didn't have to bring 17 them all back up to date before or during the meeting. 18 In closing, I believe the Agreement States 19 actually do agree with. the majority of the new Part 35, 20 however I urge the Commission to consider the statements I 21 have made~about the small number of problem areas and 22 consider appropriate. actions. Thank you.
'23 ' CHAIRMAN DICUS: Thank'you very much. And let
'24 me - I'did mention that since we are having trouble with 25 being able to hear, Commissioner Diaz suggested that if he ANIL RILEY & ASSOCIATES, LTD.
Court' Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washin3 ton, D.C. 20036 (202) 842-0034
58 1- had.vr4Luen' questions to submitithat you would be responsive 12 ' lto answering them. And he has indicated that he will have
.3 some written questions to submit He'll have those to us in 4 a ccuple.of days, and I'll channel them either to Mr.
5? Hallisey or Mr.' Marshall, depending on what topic they IL 6 happen to belon. So we will take care of that in due time. , 7- I've got a couple of questions I'd like to pose to 8 you'on the Part 35, and.I-think-you're aware tomorrow we 9' will have:a briefing on Part 35 from.the staff and ACMUI
.10 involved as well, 11 It's my understanding that there is general 12 agreement wi;-h the NRC's medical policy statement with 13 regard ~to the fact that NRC should not delve into-the 14 ; practice of medicine. ,Is that a fair statement?
15 MR. WALTER: As much as possible; that's correct. 16 CHAIRMAN DICUS: Okay. And I think then we have 17 some concerns from the NRC because you're wanting to require 18 such prescriptive requirements of authorized users, their 19 duties require selection of the patient, prescription of the 20 dose, et cetera and so forth. Do you see that as delving l 2'1 into the practice of medicine? Because I think the NRC's i 22- position maybe-is that we're getting into that arena. 23 MR. WALTER: There is no specific cutoff point
'24 that you.can-say that everything to the right of this is 25 " going to be medical, and everything to the left of this is i l
ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue,.NW, Suite 1014 Washington, D.C. 20036 (202)'842-0034
sq: 59 1 11 strictly radiation safety. The fact of.the matter is that I
-2. we requirefanyone who uses radioactive material or oversees 3 the1use of radioactive material to have a good understanding 41 of radiation _ safety and the use of these materials. And'for 5_ that. reason I. don't believe that'to the point that--- the 6 extent that we've gone we're not telling them what they have 7~ to'do as far as me'ical-is d concerned unless it has to do 8 :specifically with. radiation-safety-related mattors. To that 9 extent no, I do not believe that we're having a problem with
'10. that.
11 CHAIRMAN DICUS: Okay.. 'I think we may have a 12 slight difference of opinion there, but we understand where 13 -you're coming from, we understand that concern. 14 Let me bring up one more thing, then I'd like to
.15 .have the other Commissioners -- and this'has to do with the
. 16. l training and experience requirements on your slide on that, 17 on 35.392 and 35.394.
18 The NMED data base, which Agreement States do
- 19- . provide.information'on with regard to misadministration 20 -data, et cetera,. frankly in our opinion does not appear to
- 21' support the SR-6 concerns that, and I'm quoting what you 22 said,. iodine misadministrations pose ~the greatest biological 23 -radiation risk to the patient, I think is a quote taken from 24- .some comments that have been made.
'25 Where~is the SR-6 Committee -- what are you basing L
1 1 ANN.RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 60 l l 1 that comment on, what sort of scientific data, since the 2- NMED data does not appear to support that? 3 MR. WALTER: Let me get a little clarification 4 exactly what you mean. Are you speaking specifically about 5 the effects on.the patient or the effects on ancillary 6 personnel and the public? 7 CHAIRMAN DICUS: I was talking about the questions 8 related to the effects on the patient, but I would expand it 9 to the ancillary pe*sonnel as well as the public. 10 MR. WALTER: Okay. It only takes 30 microcuries 11 of iodine to deliver a 50-rad dose to the thyroid. We're 12 dealing with millicurie quantities that if you're only a 13 millicurie off, you're looking at a substantial difference 14 in dose. 15 Now from a patient's standpoint, that is not the 16 most important thing. The fact of the matter is using oral 17 iodine you're flooding the body so that the entire body -- 18 it's a whole-body exposure rather than a specific area of
.19 the body that would be exposed if you were using beam 20 therapy or a sealed-source device -- the vast majority of 21 the dose is going to go to any thyroidal activity or tissue 22 that is still active with then a great deal of it going to 23 the kidneys and bladder.
24 But in looking at this, we looked at the 25 misadministration data, and looking at that specifically ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
L G1 it ~ there is no.doubtLthat the misadministration -- the number
~
2- of:misadministrat' ions that occur, and we're not 100 percent 3 .. certain.on this last part that I'm about to say, but we do 4 know thatithe number of misadministrations that occur in 5~ Ltherapylare.much higher in iodine than they are with 6- ivirtually any other. kind of radioactive material, whether it 7- be sealed--or unsealed-source' medical use.
- -The question was'whether or not the percentage of 8
9: iodine therapies.that became misadministration was actually 10 higher. -There are a huge number of iodine therapies that 11 'are given in. comparison to every other type of therapy. 12' It's one of'the highest, iffnot the highest, at this point
.13 'in time. It's more than -- I would say probably twice as 14 high than any'of'the next ones after that.
- 15. But we're basing that on the biological aspects of 16 the radioactive material. You have a much larger area of I But when
'17 the body: receiving a large dose for the patient.
18 you get.out to the -- as I'said in'here, it's the ancillary
'19 ' personnel and the general.public. The general public, yes, l 20 >the general public can be exposed to the individual as a
.21 point source, but to a greater extent they're exposed to an 22 individual's. contamination that they didn't even know that i
! 23 there.was-a patient'around there.
.24 CHAIRMAN.DICUS: I don't want to take up too much 25- more. time,. so I just wanted to pursue it a little bit, and ANN RILEY'& ASSOCIATES, LTD Court Reporters 1025fConnecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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62 1 it_had.to do really, because youre working around to the 2 patient-release criterion in some ways,.and a little bit 3 concerned,about that, because, . you know, a variety of things 4 'to into'the decision on patient-release criteria, including
'5 the;well-being of the. patient,. psychologically, et cetera, -6! there are a lot of other things that have to come into that.
7 . Granted, it'is something of a problem, but I think 8 also you were: working around in your-comments the fact that
~ 9' then State radiation control programs, for that matter the
.10 NRC, may' find itself responding to alarms that are set off 11 at waste' facilities, et cetera, and therefore they need some 12 ability to recoup from these kinds of expenses. And point 13 :out that nothing in any of the proposed rules prevents that. =14' Now, I think.what you're trying to go.to, well if 15 you have a tighter grip on the release criteria and maybe 16 don't allow these patients to be released, then you won't 17- .have as many of these alarms going off. But -- 18 MR. WALTER: No, what I actually -- 19 CHAIRMAN DICUS: I'm not sure where you're going. 20 MR. WALTER: When I was saying that, what I 21- actually mean is that when a patient is released, the
'22 . licensee is generally not' held accountable for.their 23 exposure to other individuals because the data that was --
24 the equations.that were worked on show that it's unlikely 25 .that that' individual will expnse any other person to more ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
E , L . .. I 63 !- 1 than 500 mill'irem. That's all they have to do. If that l I l 2< I patient-then'goes to a-restaurant within the next two hours
]
1 3 .or less;and becomes sick to their stomach, if they don't 4- ' notify the licensee that something has happened, the I 5 iicensee"will not know anything about it and will not take
- 6. ~ any responsibility for it, even if they were going to.
7 CHAIRMAN DICUS: Well, I've actually been under 8- the impression that they are given some instructions before
- 9. they leave the hospital on certain things they should be l
- 10. doing. Are you saying that's not'the case? -
l 11 MR. WALTER: They are -- the only part that
'12 requires written instructions is if it's greater than 100 13 millirem. Okay? If there is a possibility of an exposure 14 greater than.1001 millirem, yes, there is something that is ;
15 in'there'that states that. . 1 16 But having worked with a number of these patients, 17- if you have your choice of being cooped in a room for the
'18 next'two to three days, in a hospital room with no ability
- 19. to get outside or having the ability to say I'm going to go i
- 20. home and I'm not going to go anywhere, and being able to be 2
.1 released, there is a no-brainer. They are going to say 22 whatever they think is necessary to get -- to go home.
23 The written instructions notwithstanding, that 24- doesn't.necessarily mean, knowing the_ patients, they may -- 25' there are going to be some of them that are going to be very , l ANN RILEY & ASSOCIATES, LTD. Court Reporters
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64 l
-1 . conscientious and are going to definitely call immediately 2
'2 and-say,something'about it. But I'd also believe that there 3 are a mudaer of them out there who -- _ their training is s not -- when I say adequate, I mean it's not actually clear t
- 5. in their mind that this is'an important thing that they need l 6 to make sure.that they8re doing.
7 CHAIRMAN DICUS: I think I understand what'you're 81 'saying,' but I'm not sure there's a rule that really fixes 9 .that. But -. ; 10 MR. WALTER: There isn't right now in the 11 1 Current draft.-- 12 CHAIRMAN DICUS: Well, I'm not sure that -- 13L MR. WALTER: And there may not be a possibility of 14- that. 15 , CHAIRMAN DICUS.: Right. 16 MR. WALTER: We're not -- at this point in time 17' I'm not really attacking 35-75 on its release -- allowing the-release of an individual who can receive 500 millirems, I 18 19 but -- because personally I didn't see a problem with the 20 500-millirem publ-ic dose from pre-1993. But if a person --
= 21- ;and most'of these patients will come in, if it's thyroid, if 22 they've'had-a thyroidectomy,_they very ofh.a will come in H23 'two-to three times a year, which allows their family members 24 and_anyone else to receiv e up'to 1,500 millirems in a year.
25' Is that your intent? Is that the intent of this rule, to l ANN RILEY & ASSOCIATES, LTD. j Court Peporters 1 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036- ] (202) 892-0034
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e , 65 1 allow much. larger doses per year than the 500 millirem? J2 That's!just the point'I'm making for that. 3 The.other is that you have to' consider nursing 4 h'ome facilities and other places where a lot'of 'hese t -- a 45 lot;of these' patients and their families are in support 6 groups. So they'may be exposed to not just.the one person 7 in their' family, but to numerous other patients. So now 8 we're looking at occupational exposure rates, possibilities 9 .of' occupational exposure' rates. 10 CHAIRMAN DICUS: All right. We need to move on. 11 Commissioner McGaffigan. 12 COMMISSIONER McGAFFIGAN: Well, you've talked
'13 through the patient release. I just come back tc the T&E 14- for' endocrinologists. Our data, as Chairman Dicus 15' indicates, is that endocrinologists in the practice of the 16 use of sodium iodide have not had problems. There have 17 been.-- there's two data points in the data base, and 18 neither were serious for the patient.
19' - And so the question -- if you go to 700 hours, the 20 ' endocrinologists have also testified to us that you will 21 disrupt the practice of. medicine, because-they will not be 22 able to build that into their educational programs, and you 23 basically will be denying an option for patients. We could 24 not,. based on the data we have, deny that option to 25 patients. That's the choice we made. I hope you guys have ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
n , 66 1 .a vigorous-debate, and-I think you will, because the z 2 . endocrinologists will bring it to you' when the SR-6 findings
.3 go to the br>ader community of the CRCPD.
14 The technologist T&E will -- that's not an issue I
- 5. was up to. On the embryo-fetus, when you say you're going 6; to propose to your. colleagues that you use the Part 20 7 reporting, is that 100 millirems per year?
8- MIL ' WALTER : For an embryo-fetus, it would be 500 9 millirems in the full term. For a nursing infant, it would 10 be 100 millirems or a released patient-criteria of 500
'll millirems. Yes. So I could see where 500 millirems would 12 be applicable to either of those.
13- COMMISSIONER McGAFFIGAN: As you know, the doctors 14 tend.to think of the mother and child as a unit that they're 15 treating, and so-again you're going to - I mean, this is lis - going to be one of these issues that come up against 17 practice-of-medicine considerations, and we're going to have
~18 to -- we're going to have to hear tomorrow's testimony from
- 19- 'ACMUI and the staff and make a judgment. But the staff 20 paper justifies the 5,000-millirem reporting requirement on 21 the grounds that -- I' guess ACMUI has told the staff that 22 there are no deterministic effects and stochastic effects 23 are less than 1 percent. I mean, that's the line in the 24 paper.
25 ~ So it's a judgment. It's a judgment as to how , ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
67 1 much we treat medicine as a different -- because there is a 2 clear benefit being provided by medicine -- as a different 3 thing from dealing with reactors or fuel-cycle facilities. ! 4 It's -- I appreciate your raising the issue, but I know the 5 doctors will have a very d fferent view. 6 MR. WALTER: I think originally that this was 7 brought forth because of the belief that there was no doubt 8 that you would have to have a pregnancy test done before 9 every study. But if you go and you look at the actual 10 information about the dose that would be expected under 11 normal dosing procedures for diagnostic uses of 12 radiopharmaceuticals, you're not going to find a huge number 13 of those tests that are going to expose that embryo-fetus to 14- greater than 500 millirem unless you are saying I don't want 15 a bone scan of 20 millicuries, I want one of 60. 16 COMMISSIONER McGAFFIGAN: Um-hum. 17 MR. WALTER: And that determination is something 18 that needs to be made by the physician anyway. And I am not 19 saying to any physician that they cannot dose this patient 20 if their medical decision, and I'm saying that this is their 21 practice of medicine, they can make that decision to give 22 higher doses based on the fact that this is what is going to 23 best for my patient. There's no doub', that that's what they 24 can do. They can give a 500-mill'. curie dose of technetium l 25 to do an ingrown toenail for *11 I care, as long as they say ANN RILEY & ASECCIATES, LTD. Court Reporters 10,. 4 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034
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68 1; it's the-best thing.for their patient. 2 CHAIRMAN DICdS: Commissioner Merrifield. Moving 3 on from the ingrown toenail.
.4. ' COMMISSIONER MERRIFIELD: I would weigh in,-along ~S with Commissioner.McGaffigan, in terms of the concerns 6 . relative to iodine-131, but I don't want to belabor that any !
7 more.
'8 Just a short word on misadministration and doctor 9 notification of-the NRC. This is probably the single most 10 . third-wire ~ issue for doctors, and the number of vehement 11 letters that we get from members of the medical community -12 . relative to the fact they don't believe the NRC.should be in 13- the business of-worrying about this is certainly noteworthy.
14; Similarly noteworthy in terms of the review that I have'done since I've been here'is the lack 15 surprising to 16 a certain degree'to me -- the lack of patient iuvolvement in
.17 the concerns about those notifications. I mean, we've been 18 talking about relaxing our standards for notification for 19 misadministration, and there has been no -- I would have 20- expected more comment from the stakeholder community outside 21 of you all about that kind of change, and to my knowledge we 22 just haven't gotten a lot of.that. So I sort of throw that 23 out there. I'd be interested to see what comments you get 24' when you-release.your report. I'd second Commissioner 25 .McGaffigan on that one. Thank you.
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- 1. MR. WALTER: I do want to point out that
'2 ~regardless of what'we put in'SR-6, the rationale will 1 3 specify that there is a-less restrictive option to maintain 4 Leompatibility.for.the State. And so that will be included L5 as a possibility, and.if the State.so chooses, they can go I
~6- that. route,.but that-does'not mean that that will be the l
7 ' recommendations.of our committee. 8 CHAIRMAN DICUS: Okay. Stan.
.9 MR. MARSHALL: I am glad to introduce, a bit late j
' 10.. 'but not lost', RolandLFletcher. Roland is from the state of -
11 Maryland and'is Past Chairman for OAS. He is here to talk ,
.12 :about' allegation investigation protocols.
13; .MR.. FLETCHER: Chairman Dicus, Commissioners, good 114 . morning.
'15 As.you may see from.my topic, this is something of 16 a. follow up of an area that I have'been looking at for the 17 past couple;of years. In fact,.at the Commission briefing 18' Elast year I talked about information-sharing.and at that
~
19 time Chairman Jackson recommended that I go and talk with IMI some of the-specific offices including the Office of 21" Investigations,.which.1'did, so I am approaching this topic 22 today from a'more' generic perspective. I'am not focusing.in i 23- on'. specific things although they fit into my information, L '24 but what I want to talk about.is what we see as areas of E 1 l ?25. concern and'some of the' recommendations that I think might JURI RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1 t'
1 e a 70 1 help to ease those areas. 2 One of particular concern is Management Directive 3 8-8, which is going to be highlighted on a few instances as 4 perhaps the source of a problem and the location of a 5 possible solution. 6 What we are talking about are instances where 7 investigat ons may be conducted in Agreement States and on d 6 several occasions that I am aware of'throughout the country l 9 the Agreement State program management, the state senior 10 management themselves are essentially either not informed, 11 not made aware, and for various reasons of course but 12 ofttimes we found that there are other options. 13 As I look through Management Directive 8-8 in 14 reference to the first area, the failure to recognize or 15 acknowledge Agreement State authority, in the glossary there l 16 is no definition of an Agreement State. In the procedures 17 there is no information that could be given to an 18 investigator as to how an investigation should be conducted 19 in an Agreement State. 20 As a result, what we are finding is that in some 21 instances. investigators are not taking the Agreement States 22 seriously, either because they are unaware of the 23 jurisdiction of the Agreement State over licensees within ) 24 that state or for other reasons that I don't want to touch 25 upon, but we find that their relationship in conducting the , e i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034
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, 71 j 1 investigation is often. inappropriate to successful results.
2 We also find th'at there have been instances where i 3~ .there'is'an extreme reluctance to share.information. I am I J4 !well aware that there are instances where.information,
- 5- . integrity.of information must be preserved but ofttimes the 1 6 . Agreement State once'again deals with many of the licensees j7 on a regular basis and can perhaps provide-information that 8 .the' investigator is not even aware of.
9 'There have been instances where information has
'10E been shared with either the Headquarters or the region'and 11? the investigator from one or the otherLis not aware of that 12' information. I' find that'a little difficult to understand.
113; So what happens is there is;a reinvestigation of 14: investigations that have already been, conducted and'that 15_ . leads;to some problems with the Agreement-States. 16 There is. ofttimes staffs who in many instances, as , 17 I said.before, are,very. familiar with certain licensees and 18 .they have information from cradle-to-grave about certain 19 ' licensees. It may be an instance dealing with reciprocity, 20 it may be an: instance.just dealing with some concern, but 21; some contact or at least ---well, some contact or
' 22- communication with a member of the Agreement State staff 12 3 .might be. beneficial for those conducting the Agreement 24 --l State.
25 The last is-I guess a perception, a feeling that ANN.RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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i 72 1 'is shared once again by.many. Agreement State individuals, 2 ahd';that.isthat'ofttimespersonnelaremadetofeelas 3: though they do not'have the expert'ise, they do not have the 4 ' competence, they do not have the relevant information that 51 an investigator should bother to seek. This is very far 6' from the truth andlI think it does not aid in continuing to 7 -build and strengthen.our partnership.as far as handling 8 these types of investigations. 9 .I have some recommendations that hopefully we can 10 jointly pursue and that is perhaps when information that 11 requires an investigation is revealed either through an 12 allegation or-other'information an analysis is done as to
.13~ whether or not this information should beiprecluded from an 14 Agreement State. I am not sure that this should be done by 15 an; investigator. I.think there-has to be some contact with 16- the Agreement State personnel at that headquarters, either 17 at the region or at the headquarters' level to make a 18 rational determination as to whether or not this 19 investigation might be aided by contact with the Agreement 20 State.
21 There needs to be, I believe, more information,
;22 perhaps even a paragraph or procedure, outlined in the 23 Management Directive giving guidelines on appropriate 12 4 -contacts and appropriate procedures to be followed when 25 pursuing an Agreement State licensee within an Agreement i
F ANN RILFY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
a . ! 73 1 State. I haven't-seen anything in-here. I have been over ;
' ~
'2 -it a couple of' times.
.There is'a reference to referring 03: allegations to AgreementJStates but there is nothing-that I ;
14 have been able'to uncover that says this is how you 5 coordinate with'an Agreement State. 6 JWhenever there's instances suchEas reciprocities 7 some states [have indicated that they. find out the day after 8f .that an. investigation has taken place'in their state. There 9 nee'ds to be some-precoordination and-I think in the best 10 interest' of partnership-perhaps there needs to be some joint 3 11 communication'with the' licensee. Unless there is some.real 12 reason'to preclude it, I think this would.be very helpful.
- 13. I believe that once anEallegation has been
'14 referred-to Agreement State and that'it is completed, if 15 there-is no-follow-up'on such a' thing there needs to be a
; 16 - 'real good reason why and there needs to be communication 17 between the region'and the headquarters when such a thing 18 happens'and there have been instances throughout.the country i 19 where that'has not occurred.
20 When final reports of Agreement States for 21- allegations are prepared once again, and I am not making T22 ! l light of the need for. confidentiality, but I do find and 23 states have indicated that there.have been instances where 24: they have been blindsided on'information within their own L L 25 ' state':and this does not bode'well with the states and their ; l l l ANN RILEY & ASSOCIATES, LTD, Court' Reporters i J1025 Connecticut Avenue,, NW, Suite 1014 L Washington,- D.C. 20036 , (202)' 842-0034
74 , 1 state government oversight. 2 I believe I have already mentioned about the 3 reciprocal investigative information exchange process. What 4 we in Agreement States normally do is whenever we have a 5 violation that occurs under reciprocity we will communicate 6- with that licensee but any follow-up will normally take 7 place within our state under the reciprocity agreement. We j 8 will not normally pursue that licensee into an NRC state and 9 if that should be necessary, we should feel it's necessary, 10 then we communicate with the NRC. We only ask that the same 11 process be afforded to states if such is deemed appropriate. 12 As in other instances, and I know that we in 13 Agreement States are always pressed to find the time and the 14- energy and the individuals to do so, but I believe this is 15 another instance where we get to know each other better when 16 we demonstrate that we are doing the same thing, we have the 17 same mission, we have the same intent and we want the same 18 results, so some type of a joint system I believe would be 19 preferred. 20 These are the things that I wanted to present as 21 far as concerns and recommendations and I will entertain 22 questions. 23 CHAIRMAN DICUS: Thank you for your comments. 24 This is a somewhat complicated issue. It may not lend . 4
}
25 itself easily to resolution, but whatever appropriate 4 ANN RILEY &' ASSOCIATES, LTD. Court Repormers 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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75 1- methods are availaP- for us to discuss these issues, we 2' ~ certainly'I think would have an open mind to doing it. 3 I think one of the things we have to keep in mind 4l is whenever there is a situation where there is sensitive 5 material or.the need to protect sensitive information, an 6 alleger, whatever, some states-do not have that ability to 7 protect that information. That is one of the complications 8- Lthat we must deal with when we deal with this sort of issue. 9 Commissioner Merrifield? 10 COMMISSIONER MERRIFIELD: There are a couple of 11 things that got raised.that I would like to comment on. 12 I-think one of.the things that bothered me in your 13 presentation was the: area of concern,.your statement that 14 there's a tendency to treat Agreement State personnel as 15- co-conspirators in wrongdoing investigations. I 16 I.would say two things relative to that. First, I 17 think we have a Office of Investigations we feel pretty 18' confident in. We think they do a pretty darn good job 19 around-here. Now that is not to say that there may not be 20 an individual investigator who may not have the appropriate 21 attitude relative to state personnel. 22- We as an' agency obviously have provided for -- 231 have given;the responsibilities to the Agreement State to 24- runsthese programs. With that comes a respect of this ! 25 agency'for this program and'that should run up and down ANN RILEY & ASSOCIATES, LTD.
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76 L1 throughout our agency, and so it does' bother me.that at 21 least'your impression is that we have investigators that are 3' treating you, our colleagues,'in some disrespectful manner, 4 'and that.is certainly something I think we can go ahead and
=5 take that-as'a lesson learned.and look at.
6 We are professionals. We should treat-it as a 7' professional relationship and it would be unfortunate for 8 .you to feel that you were treated in a disrespectful manner. 9 That having been said, the issue of our sharing 10 this:information, as Chairman Dicus has mentioned, is very 11 sensitive. I am aware since.I have been a Commissioner of 12 one investigation that was underway in which I wasn't even 13 able'to share'with'my staff activities relative to an .14 investigation, so that the need for tight control over this 15 is very-important. J16 The preferences in the federal whistleblower 17- -statutes are to protect' alleger confidentiality -- when in
~
18 doubt protect that alleger, and so we have to act with great 19 care in terms of making'sure that we meet those goals of 20 federal law.
'21 Now that is'not to say that there may not be some 22 way in which we can explore a manner in which we can provide 23 some' greater information. I don't know. We certainly 24 haven't tasked the Staff to do'that. That may be something 25 ~ worth' a discussion: between yourselves and members of our i
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'1/ ' Staff'to see if therefis a.way of having better 2 -communication'and better interaction so that we are treating
- 3- you in a fair and profes'sional manner.
14 MR. FLETCHER: And I am very, very' sensitive and I 5 thickiI' mentioned to the need for confidentiality and the
~6-l sensitivity.of information. States also, many states -- I
'T -am'sure it is not all -- but many states also, I mean we 8 conduct investigations and we have the same kind of protocol 9 and all'I.am saying is that-in those instances where those loi th'ngs i don't apply'there needs,to be more sharing of 11- information.
12 . COMMISSIONER MERRIFIELD: Well, maybe what we are 13 doing here is-applying a one-size-fits-all method of dealing
~14 with these issues here at our agency, and.maybe we need to 15: explore setae way. of being more flexible on more of a case by 16 . case basis. That is something to at least consider.
17- CHAIRMAN DICUS: I think that is one of the things 18 'we mentioned,: that whatever way is appropriate and proper 19 that'we can address some of these issues I think we would be 20 willing to do so. Commissioner McGaffigan? 21 ~ COMMISSIONER McGAFFIGAN: I don't really have a 22 questi'on, but' I do see, as Commissioners do, the monthly OI 23 report, and I can't recall very many cases -- I mean the 24- vast majority of the cases are reactor sites, et cetera, 25 .that are open OI. There aren't too many, on an annual ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 t
1 + < 78 14 basis,fthat-I can-recall off'the1 top of my head -- , l L 2' investi$ations in'an' Agreement State or.something that is in 3 .your" jurisdiction. I think it is a: sensitive matter when it l 1 4 comes up but-I don't think the numbers ~are very.large. 5: CHAIRMAN DICUS: No. Mr. Bailey? l 6 [ :, MR. BAILEY.: Alphabetically I'm first. 1 7- * . CHAIRMAN DICUS: :Well,-I saw two'. hands. l 8 MR. BAILEY: We had'a: problem some time ago in
- 9. regard tolwhat ~I.am sure was just a formatted letter that 10- =came out and said we have'gotlthis complaint -- this
'11- allegation about the use of an x-ray machine, it is not in
~
7121 our jurisdiction, but oh, by the way, give us a report back 13' 'in130 days how~you handled it. 14' .So.we.went to Region IV and we said, hey, just j
/look at1your letter, and I am happy to report that they did. I -15 ~ 16 -They looked at it and caid, okay,'this is in your-17 jurisdiction,.'it is not in ours and so we are referring the .18 . . allegation.to.you.
19 'But I understand'the' frustration on several of 20 these that have been referred to us to investigate. We 21 don't get a-name so we don't know who the guy is and what we i
- 22' do , what we have:done, is gone to the licensee and then they
- 23. t' ell-us who the alleger is and then we can investigate them, 24 so-when we do get these letters down that do involve 25 Agreement State materials and we don't know who the alleger i
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79 1 was it is:veqr' difficult in many. cases _to follow up, to see 2 if there is in fact any truth
- , but-when you go to the i.
R3 company they-are:very seldom saying okay, you caught me, I'm , 14 guilty. You have got to go to someone else. MR. MARSHALL:
~
Si That's real similar to what we've 6 had.4 One that I-had in the last year was that we have a 4
.7l : report allegation that one of-your. licensees -- and they
.8 gave usLthe licensee'name -- has radiation safety problems.
9' That's it. 10 Where do we start,;since we can't talk to the ll ' alleger? It really made1it hard for -- you know, we've done 12 inspections,'we look at-this, and I think that's where you 13 run into.the problem is we can't really do'our job -- , 14' COMMISSIONER McGAFFIGAN: It isn't'us-15 investigating you, it's -- 16_ jMR . MARSHALL: 'Right.
- 17. COMMISSIONER McGAFFIGAN: Turning it over --
'18 MR. MARSHALL: Turning it over so that we can --
19 where do we-start? 20 COMMISSIONER McGAFFIGAN: Have enough information.
~ 21 Okay.
R2 2 ~ CHAIRMAN DICUS: All right. I think we can effect 23 some improvements there.
'24- Okay, Mr. Marshall, is there anything else?
25- MR.dMARSHALL: I truly appreciate Bob's patience. ANN RILEY & ASSOCIATES,:LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
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80 3 1 1 I'm going to try to take one breath and get through a couple 2 ' slides very quickly. 3 The last item is the OAS resolution to support 4 NRC-proposed budget. I truly appreciate, on behalf of the 5- States and the executive committee, appreciate the 6 attendance and participation of Chairman Dicus at the recent 7 Agreement State meeting in Austin, Texas. At that meeting 8 we discussed what we understood was the NRC-proposed budget 9 to include some additional funding to address NRC 10 initiatives involving Agreement States. At a business 11 session of the attending States a resolution was proposed, 12 discussed, and passed by those participating in the business 13 meeting. 14 The next slide indicates that the 29 States 15 participating in the discussion voted unanimously to support 16 the resolution, which we sent to Chairman Dicus, as well as 17 to the Senate and the House Finance Committees. In the 18 resolution States were also encouraged wherever possible l 19 'within constraints of communicating to legislatures to also 20 support such budget. Many States have struggled, and I 21 believe most, I'm proud to say, have been successful to get 22 our own dollars to come to our own OAS meeting. I was 23 pleased-that we had as many States, including Ohio and even 24 four other -- I don't mean it derogatorily, but Agreement 25 State wannabes. There were the four additional States ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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- <- -.- 1 81 11 looking;at the option, and we look forward to continuing the .
)
M2 relationship in this national program with maybe your help
-3 to --'
-4 CHAIRMAN DICUS: Okay.
L L 5 .MR. MARSHALL: That's all I'm going to say, and i
- 6 defer the balance of time to the Chairman and Bob Hallisy. ,
7l CHAIRMAN DICUS: -Thank you.
.8 Go ahead, Bob.
9 MR. HALLISEYi Good morning, Chairman Dicus and 10 Commissioners McGaffigan, Merrifield, and Diaz. My name is 1
~
- 11. . Bob Hallisey, and I am the-Director of the Radiation Control 12 Program, but I'm here this morning as the current Chairman l 13 of the Conference of Radiation Control Program Directors, ;
l 1-4 commonly referred to as CRCPD. 15 I am also the Director of the Massachusetts L 16 . Radiation Control Program, which on March 21 of.1997 became 17 th'e-30th-Agreement State. 18- In this' respect, I want to relate to the 19 Commissioners how proud and pleased we are to have entered 20 into this agreement with the Nuclear Regulatory Commission, 21- and what a tremendous effect this has had on the identity of 22 Lour program within the State government, our relationship 23 with the medical community, academia, and industry in the 24 Commonwealth.of Massachusetts, and the professionalism and 25 great sense of accomplishment of our expanded staff. I-ANN RILEY & ASSOCIATES, LTD . Court. Reporters 1025 Connecticut Avenue,.NW, Suite 1014 I Washington, D.C. 20036 (202) 842-0034 l
82 1 1Becoming an. Agreement State to us was the final ! 2 step towards a comprehensive radiation control program, and 3~ Massachusetts would like to take'this~ opportunity to thank 4 -the Commissioners and all of.the staff of the NRC, and 5 especially' Paul Lohaus and the staff in the Office of State
,6 Programs, for all this work in making this happer, and for 7 'the continuing excellent relationship.we have with all the 8 staff that we have experienced as a new Agreement State, no 9 . longer-the baby,Tthough,'now that' Ohio is.
10 Back to~CRCPD, which is the primary purpose of my 11 ,being here. I thank you for this kind invitation, and I 12 would'like to tell'you a' bit about CRCPD and to briefly , 13 1 relay to you some related issues that our organization l 14L . wishes to call-to your attention. i
'15 Many of our issues have'already been addressed by 16 Lthe Organization of Agreement States, because obviously all 17 of the Agreement States are part of the conference.
18 The conference is a nonprofit organization 19- incorporated in the State of Kentucky, with our principal
'20 offices there in Frankfort, and incidentally our 31st annual i
21 meeting was held last May in Louisville, Kentucky, and the 22- Chairman-was present'at that meeting. 23 The.overall~ purpose of the conference is to 24 . provide atcommon forum for the exchange of information among 25 State and local radiation programs, and also to provide a i J ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 : Washington, D.C. 20036 (202) 842-0034
83 1 mechanism for States to communicate with the Federal 2 Government on radiation issues. 3 Our mission is to promote consistency in 4 addressing and resolving radiation protection issues, to 5 encouragr high standards of quality in radiation protection 6 programs, and to provide leadership in radiation safety in 7 education. 8 Our overall goal is to keep'the radiation exposure 9 to the patient, the worker, and the general public to the 10 lowest practical level, whil.e not restricting the beneficial
-11 uses.
12 Our members are State and local radiation program 13 directors and their staff, staff of radiation-related 14 Federal and international agencies, individuals from the 15 medical profession, academic institutions, and the radiation 16 industry, and some retired radiation protection 17 professionals. We have about 1,000 members. 18 The activities at our organization are divided 19 into five separate councils, depending upon the matter -- 20 subject matter of the committee and task force. 21 The five councils are the Healing Arts Council, 22 which deals primarily with X-ray matters; the Environmental 23 Nuclear Council, which deals with radiation environmental 24 matters; the Suggested State Regulation Council, which 25 oversees the various working groups. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
4 84 l l 1 (Increase in amplification.] 2 I'm not going to start again, though, I hope. l 3 CHAIRMAN DICUS: Your voice carries so well. 4 MR. HALLISEY: I apologize for that. 5 The Suggested State Regulations Council, which 6 oversees the various working groups that develop the 7 SSRCR's, a General Council which oversees all of our liaison 8 activities with various Federal and other organizations, and 9 now a Special Council which oversees the task forces that 10 report directly to the Executive Board, such as our Trading 11 Commission and our Strategic Planning Group. 12 CRCPD, through cooperative agreements, works very 13 closely with numerous Federal agencies, in addition to the 14 known activities that we have with the Nuclear Regulatory 15 Commission. l 16 We work very closely with the Food and Drug 17 Administration in the diagnostic X ray area and in the 18 mammography area; with the Environmental Protection Agency 19 in the Office of Radiation and Indoor Air in our ! 20 decontamination and decommissioning issues; MOSSUM, orphan 21 source, low-level radioactive waste, radon, NORM; with the 22 Department of Energy with our low-level radioactive waste, 23 hazardous waste sites, orphan sources, and norms in l 24 transportation of radioactive materials; with FEMA, the ( 25 Federal Emergency Management Agency, on our offsite reactor ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
U m ., . 85 l l' . emergency. planning and_ response, our potassium iodide L 2 protection issue, emergency guides in pathway analysis. 3 Some other-Federal; agencies that we deal with are f -- 4' Department:of Transportation, CDC, Department of
-5 Agriculture, the National Institutes of Occupational Safety l 6 and Healthi~and'some State:-- Department of State on Import l
l 7 _and Export Issues; l 8' Professional' organizations that we work with are 9- numerous and many, and I won't name_them all, but they L 10 include the Health Physics Society, the American College of 1 11 Radiology, American College of Medical Physicists, our 12 Association of Safe Drinking Water Administrators, the C' int 13 Commission on Accreditation of Hospitals, the National 14 Governors Association, and the National Council on Radiation 15 Protection and Measurements. 16 I did want to call to your attention some special 17- services of'CRCPD that we are'especially proud of. One is 18 our accreditation of regional calibration laboratories, 19: traceable back to standards for survey instruments for State 20 use. 21' The second is our program of recognition of l' 22'- licensing States,-those that-license NORM uses. L T23 The third is our issuance of special 24; transportation authorization for shipping of radium. 25 The fourth is we coordinate and broker the Texas l l-l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025. Connecticut Avenue, NW, Suite 1014 p Washington, D.C. 20036 L (202) 842-0034 i.
= 86
.1 ' Industrial Radiography Examination to States. And we also 2- . coordinate and conduct an' annual national conference on 7
3 radiation protection, which is now involving many other 4 associated agencies and organizations with us.
, .5 .WeLalso conduct comprehensive' reviews of State 6: 1 radiation' control programs using a team of experts. These 7- reviews are.similar.to the IMPAIR process, and they're done 8; by request.to,the State to review the entire State radiation 9 control program,.and 12 States so far have been through this
.10 : process, and we've'used'in additional to NRC EPA and FDA 11- ~ representatives for their respective program areas.
12 We are especially proud of our numerous 13 . publications, which are disseminated widely in the radiation 14 protection community, such as our bimonthly news brief, the 15 directory of personnel responsible for radiological health. 16 Thie directory lists addresses and telephone numbers for 17 many-of the key individuals in the radiation arena. This is 18 a directory.of professional personnel and State and local L19 . government agencies who administer radiation control
- 20 activities. And in selected Federal agencies, certain U.S.
'2 11 . territories, Canada, and Mexico who have radiation 22 protection responsibilities.
23 I have brought with me copies of the 1999 24 directory for each of you, and I have instructed the CRCPD 25 -executive office to .mee that.each of you are sent a copy of
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4 6 87 1 next year's directory when it comes out in January. 2 Hopefully you'11 use it to contact any of us for any issue. 3 We also have the publications of our proceedings, 4 our annual national conferenc, in which all of our 5 presentations and papers are presented. We also have a list 6 of State contacts that can be used during radiological 7 emergencies. Our radon culletin is widely disseminated 8 throughout the country. We also do profiles of State 9 radiation control programs which are available for the 10 numerous programs that have participated that list program 11 staff, budget, salary ranges, job descriptions, et cetera. 12 And we also do various technical reports relating to 13 radiation protection. 14 Lastly I wanted to mention our Web site, which is 15- CRCPD.org. And on the Web site, which we hope you will 16 visit, we have all of our SSRCR's, we have some technical
- 17 papers and publications, and a method to communicate and ask 18 questions at any time of the conference.
19 Over the years CRCPD has taken positions on many 20 radiation-related issues. The conference has three 21 different forms of positions. First is the position of a 22 task force or a committee. As a matter of fact Dave had 23 mentioned as a committee chair certain positions that his 24 particular committee had on Part 35. 25 The next step up would be an executive board 1 I I ANN RILEY &' ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l 1
88 1L position where an item is brought to the board and the boar'd 2 . votes.on it unanimously for that position.
-3 And the third step up would be a conference 4- position for'all of the members, which is done primarily 5 through. resolutions.
6-. With these three types of positions-'in. mind, I 7 wouldLlike;t_ Jiefly like-to call ta) your attention two 8 resolutions of'the conference relating to current issues. 9 'First is a resolution which was first in 1993 in 10 'which CRCPD resolved to formally request Congress to amend "11' theTAtomic Energy Act to provide for- the regulation of the - 12 -Department o" Energy.by,the NRC. The conference is aware of 13 the continuing. discussions on this issue and offers our 14 assistance to the NRC-in this area. 15 The second resolution, which was passed in 1998, 16 related L to the regulation of 11(e) (2) . material-and the 17 transfer of FUSRAP to the Army Corps of Engineers. 18 The remainder'of my comments are from the
- 19. executive board'and the committees and task forces. We want
.20 t'o' convey to the Commissioners.our sincere appreciation for 21- NRC's' role in the CRCPD orphan source initiative and the 22f importance of NRC's continuingnits support to-locate, track, 23 . provide for theidisposition of, and overall management of 24 .these orphan sources. 'This is a very intense interest to 25' the States, CRCPD,'as well as internationally. F~ must not 1
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1 1 89 3 I let this initiative be weakened, but rather strengthened. l i 2 Secondly, with more and more States signing 3 agreements with the NRC, the conference has been thinking i 4 about a potential role in providing guidance and rules to 5 States in the future. At some time in the future, probably 6 95 ptrcent or greater of radioactive material licenses will 7 be issued by Agreement States. At such time it may not be 8 economically feasible, as you know, for the NRC to continue l 9 its current regulatory program for such a small number of l 4 10 licensees. However, there will still be need for national 11 guidance and regulatory development to assure consistent l 12 regulatory control. With our experience in CRCPD conducting ; 13 comprehensive program reviews, in developing the SSR's, and l 14 our licensing State process, we are looking to put together 13 a blue-ribbon panel committee to investigate CRCPD's 76 potential role in this area. 17 Next we support and sympathize with the NRC as you 18 deal-with the concept of establishing in regulations release 19 levels for solid materials. 20 We also support the NRC's effort to establish an 21 expanded NMED data base to cover all incidents. 22 We also applaud your efforts to get accountability 23 of GL sources and devices. 24 Lastly, the conference supports the NRC budget 25 request to receive general revenue funds to support the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
90 l' -State andiinternational' programs of the Nuclear Regulatory 2' Commission. 3 Again, we thank you for'the opportunity to speak
-4 before youlthis morning, and I'd be happy to entertain any .5- comments or questions at this time. ~6 CHAIRMAN DICUS: Thank you very much. We do thank 7- -you forfthe. support OAS and CRCPD did give us in our budget i 8 quest'. We weren't quite successful this year but we will.
9 keep trying to get'where we want-to be with regard to 1
- 10 getting some things off the fee base so we can continue to 11 support" programs.that we think are very vital to radiation 12' safety.
13 .I~only have one question. You mentioned that 12 14~ states had undergone a comprehensive review of their 15 programs by CRCPD, by your panel. What was the general 16- findings, the outcomes of.that? 17 MR. HALLISEY: 'Most of the states have a positive 18- outcome from that. They were looking for a review of their 19 program to determineRif it was comprehensive enough and also 20 to go back to their hierarchy-for support to expand the 21 - program in. areas in which it was lacking. . I 22 In the majority of the instances, the process 23 worked. The states were able to get better support from 24 their organizations, increase their budget. 25- ' CHAIRMAN DICUS: All right. Commissioner I l i l ANN RILEY & ASSOCIATES, LTD. Court Reporters i 1025 Connecticut Avenue, NW ,- Suite 1014 Washington, D.C. 20036 (202) 842-0034
4 , e' a .91 ,
- 13 McGaffigan. 1
.2 -COMMISSIONER ~McGAFFIGAN: .I was just going tc ask
'3. who is the current CRCPD representative to ISCORS, the 4 Interagency Steering Committee on Radiation Standards? Do 5 you: happen to.know? )
-6 MR. HALLISEY: Yes, I believe it is the second
'7 Past C.i. ?ir, Jill L Lapodi .
'8 COMMISSIONER McGAFFIGAN: Jill Lapodi? Do you
.9 personally have any view as to how ISCORS is working? -Maybe 101 it would be second-hand from Jill or.one of the things we 11 1 -have.tried'to push is to.open more of the meetings. We have 12 had a couple open meetings when they happened to be here, i
13' 'but do you.have any. views on how the ISCORS process is 14 working? 15 MR. HALLISEY: Well, Commissioner McGaffigan, I am ; 16 sure that if you know Jill Lapodi, her response would always 17 be on'a very positive. vein, and I know she is very intense'
- 1EL .with the ISCORS issue, and she has reported back to the
.19 -Board.that she feels that the process is working'and looks 20 forward to continue working with us.
- 21. COMMISSIONER McGAFFIGAN: Okay. She may be more 22 positive than is appropriate --
23_ MR. HALLISEY: That may be -- 24 COMMISSIONER McGAFFIGAN: -- in that instance. 25 You mentioned the possibility of some day, if we
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a.. . . - . 92 a .
.1' have:very few Agreement States left, ISCORS potentially !
2 becoming a . body 'that ' would -develop . rules and regulations for 3 the nation. 4- , That11s:something that I know the Chairman
- 5. mentioned once in a speech. It,will require legislation and
-6 itLmay. anthat is some jears off,-butrit is a fairly 7 profound, change that we are going to need to do some 8 thinking'about because it will; require legislation almost' 9 ' surely. l l
10 There will be a lot of: people thinking about'it 11 and-I'am-notisure. You know, if we can get things off the 12 fee base, then we'may be able to maintain that core 13- rulemaking capability here, working with you all in the way 14 -that-currently we do. If resources are really, really tight 15 and' Congress wants this outlet -- but you aren't going to do
.16 it for free-'either, right?
11 7 '[ Laughter.] 18 COMMISSIONER McGAFFIGAN: So I suspect, you know, i l 19- maybe your choice is whether-they give us the resources off J20 the. fee base or they give CRCPD the resources off the fee 21' base in order to have this rulemaking capability. E22 MR. HALLISEY: Much of our ru'emaking activities j 1 23 have been done by the Conference based upon contributions to 24L the operation of the Conference from various federal 25 agencies. f-( ..
\<
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93 1 COMMISSIONER McGAFFIGAN: Right. 12 CHAIRMAN DICUS: Commissioner Merrifield. 3 COMMISSIONER MERRIFIELD: Just a couple of things, 4 because I do want to follow up Commissioner McGaffigan on
-5 that.
6 Appreciate the kind words in a number of the' areas 7 you spoke'about in terms of our budget, in terms of DOE 8- external l regulations, support-for our trying to get some 9 money for general revenues for state programs -- appreciate 10 all those very kind comments. 11 One of the things you did mention was the issue of 12- orphan sources. I think tuost people know but it is 13 certainly worth repeating that Chairman Dicus has been a - 14 real leader in making this element of the program happen, 15 and I think it should be noted -- her active support based 16 in part on.her prior experience with your group, which has ; l 17 led this agency.into that effort, and she is to be 18 congratulated for that. 19- On the issue of our lasting materials program, I 20 am as fervent a member on this Commission in terms of being 21 a federalist, in being supportive of Agreement States coming l 22; into this program and taking more responsibility for the i l 23 . material' areas. That having been said, I think there is a 24 logic in having a national program through the NRC to set l 25 the standards. The question is how big should that program l l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 1 (202) 842-0034 i 1
94 1- .be as'we move out into an area where we have an increasingly 2- . larger.and larger number of. Agreement States. 3 'I believe that our Materials staff is excellent.
.4 I.think they do a very good job'and I think it would be 5 unfortunate to-lose the capability.that we have as a 6- national agency to conduct'those programs.
7 -An effort to have you take some of that, obviously 8 .there's some difficult funding issues. There's also the 9 issues of economies of scale, the fact that we have got all 10' those folks here in one agency in one place clearly makes it 11 easier than trying to have=50 states plus the territories 12 try to replicate the same thing and-so as you go forward 13, with your blue ribbon panel, I certainly would leave that 14 with jou from my personal standpoint. 15- We have a problem right now, and our problem right 16 1r'w is that there are more Agrecaent States. We have fewer
.17 material licensees. We are continuing to place an 18 unfortunate burden on that group for an increasingly larger 19 portion of the Materials program.
20 We need to do those Materials program efforts'. I L21 believe our efforts to'try to get those efforts off the fce
- 22. base and into general revenues because they benefit all 23 American people whether they are Agreement States or not is 24 :important. As.I did before, I would urge you to the extent 25 you can to rachet-up even further_your. efforts to be in ANN RILEY & ASSOCIATES, LTD.
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r-l 95 L l 'l ' touch with members of'your delegation to let them know the
' 2. .importance ofLthose programs.
i l' 3' CHAIRMAN:DICUS: And assume they did call you -- E .i-L 4' [ Laughter.). 4 5' COMMISSIONER McGAFFIGAN: Like McGaffigan and
.6 Merrifield.
[
.7 - : CHAIRMAN DICUS: Anything else?
l 8 COMMISSIONER McGAFFIGAN: No. 9: CHAIRMAN DICUS: Did you have anything you wanted
- 10 .to add? Comments?
11 ;CO MISSI'ONER McGAFFIGAN: I think Mr. Marshall had 12 'a closing statement.
-13 CHAIRMAN DICUS: Okay.
14 MR.' MARSHALL: We are pleased for this opportunity
' 15 . again.- This has been a very interesting,. challenging and 16f ' enjoyable: time as Chairman. I will~ relinquish gavel on 17- -January 1 to Ed Bailey as the new Chair and'we look forward i
118 to the next Commission briefing. 19' CHAIRMAN DICUS: -Thank you -- and I remind you
.- l 20 again that you will~get some questions in writing from 21 Commissioner Diaz, and as I said before, I will channel L22 those to-the: proper. place to try to get the answers.
23 COMMISSIONER MERRIFIELD: Chairman? Just before a , you make your closing comments,: I would just like to put a 24-251 . plug;in, as they did for their website -- l ANN-RILEY & ASSOCIATES, LTD. L . Court-Reporters
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_g . . 96
'[ Laughter.]'
1. 2' COMMISSIONER MERRIFIELD: NRC. Gov -- in addition,
'31 hopefully if.we:are successful'and things work out, perhaps
- 4- next year when you have your meeting.we'will do it -
15 videostreaming softhat your colleagues will~also be able to 6' .see it;on the Internet.
.7- CHAIRMAN DICUS: Yes.
l 8 .- COMMISSIONER ~MERRIFIELD: And if --
.9 iCHAIRMAN DICUS: That is something we are working
]
-101 on .-
.11 COMMISSIONER MERRIFIELD: In place hopefully in 12- place by the end of the year.
CHAIRMAN DICUS: Yes. Yes, that is -- okay. 14- Thank you for bringing that up. I had forgotten about that.
'15 We'are looking forwardito being able to do that.
16 Well', again, on-behalf of my fellow Commissioners 17i I'want'to thank both-the Organization of Agreement States
.18 and'the Conference of Radiation Control Program Directors 19 .for another very informative briefing. It is clear from our I
L20 discussions.today that I think we have-made a lot of 21_ progress-in pooling our resources to. work together and 22- achieving consensus on many topics of concern to both of all-
.23 of our regulatory' programs.
-2<r As I noted at the OAS Annual Meeting in Texas in ;
25_ ' September, states have steadily increased their
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i 97
.1- opportunities for early involvement:in regulations, guidance 2 'and other regulatory development activities and now play a L3- much more significant. role in. helping direct and shape the 4 NRC. program. Part of that ongoing involvement includes a 5 'new-direction, an. exchange of ideas for including more 6- performance-based, risk-informed decision-making processes 7- .in our-routine. interactions with all of our stakeholders as
.6, well as inclusion of these ideas into revised regulations.
9- Since the public's health and safety is paramount
'10 in-all of our'eddeavors we must take it upon ourselves to 11 reach beyond our comfort level with the old way of 12 developing _ regulatory strategies and instead use our i i
13 ' technical competence and insights drawn from past operating 14 history to better focus licensee and regulatory attention on 15 design orLoperational-issues commensurate with their 16' importance to health and safety. 17 A solid materials regulatory program in the United
' 18. ' States helps provide reassurance to our stakeholders that we 119: are:and'we will continue to work together to resolve 20 -regulatory issues-that are of mutual concern.
r 21 Again'I thank~you.very much and unless my fellow 22 Commissioners have any further questions or closing 23 comments, this meeting is now adjourned. T24 .(Whereupon, at 11:44 a.m., the meeting was
-25; concluded.]
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. c.- ,
's CERTIFICATE.
-This.isotoJcertify thatfthe attached description of a meeting of the'U.S. Nuclear' Regulatory' Commission entitled:
~
TITLE'OF-MEETING: - MEETING WITH ORGANIZATION OF AGREEMENT
. STATES.AND CONFERENCE OF RADIATION
. CONTROL PROGRAM DIRECTORS PUBLIC MEETING PLACE OF MEETING: Rockville, Maryland DATE OF MEETING: Wednesday, October 20, 1999 was held as herein1 appears; is a true and accurate record of the meeting, and that.this is the original transcript thereof
- taken. stenographically by me, thereafter reduced to typewriting by me or under the direction of the court
' reporting company 1
Transcriber: Rose Gershon Reporter: Mike Paulus
s
- Virglho - 05SNRGGOMM5MFha102099. doc - __ Pa 931 ]
/_
- f. I 1
OA 3 Organaation of Agreement Scates Rev 10/12/99
- Stan Marshall, Chair Kathy Allen, Future Chair- l Elect l
'- Roland G. Fletcher, Past Chair . Richard Ratliff, Secretary Edgar Bailey, Immediate Chair-Elect ORGANIZATION OF AGREEMENT STATES NRC COMMISSION BRIEFING REINVENTING NRC ALLEGATION -
INVESTIGATIONS IN AGREEMENT STATES Presented by Roland G. Fletcher - Program Manager Maryland Radiological Health Program PAST-CHAIRMAN, ORGANIZATION OF THE AGREEMENT STATES
7(osetta Virgilio - OASNRGCOMMtsMP NG.102099. doc PCg3 2 l 4-October 20,1999 Rev 10/12/99 ) AREAS OF CONCERN: I
- FAILURE TO RECOGNIZE OR ACKNOWLEDGE AGREEMENT STATE AUTHORITY.
- RELUCTANCE TO EXCHANGE INivnWIATION PERTINENT TO AN AGREEMENT STATE LICENSEE.
I
- LACK OF COMMUNICATION BETWEEN NRC HEADQUARTERS AND THE REGIONS.
- INEFFECTIVE UTILIZATION OF THE EXPERTISE ON AGREEMENT STATE STAFFS.
- TENDENCY TO TREAT AGREEMENT STATE PERSONNEL AS CO-CONSPIRATORS IN WRONGDOING INVESTIGATIONS.
POSSIBLE NEW APPROACHES:
- IMMEDIATE NOTIFICATION AND DISCUSSION WITH AGREEMENT STATE STAFFS ON ALL INVESTIGATIONS INVOLVING STATE LICENSEES, UNLESS SPECIFIC FACTS PRECLUDE.
- ACKNOWLEDGEMENT OF AGREEMENT STATE JURISDICTION.
*. REQUEST FOR THE OPPORTUNITY TO MEET WITH LICENSEE.
- ACCEPTANCE OF COMPLETED AGREEMENT STATE ALLEGATION INVESTIGATION REPORTS UNLESS SPECIFIC NEW INFORMATION PRECLUDES. ;
- SHARING OF FINAL REPORTS OF NRC INVESTIGATIONS OF AGREEMENT l
STATE LICENSEES.
- A RECIPROCAL INVESTIGATIVE INFORMATION EXCHANGE PROCESS IS NEEDED.
- INITIATE MORE JOINT INVESTIGATIONS OF ALLEGATIONS "ALA" IMPEP.
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l EXTERNAL REGULATION OF , THE DEPARTMENT OF ENERGY FACILIT1ES Edgar D.- Bailey, PE, CHP California Radiologic Health Branch External Regulation Pilot Projects , Lawrence Berkeley National Laboratory Oak Ridge National Laboratory (LBNL) Radiochemical Engineering Development t Center ~(ORNL/REDC) Savannah River Site Receiving Basin for Offsite Fuels'(SRS/RBOF) j q,* *a.1 . COT 9 , 1
i . CALIFORNIA DOE SITES , l
. Lawrence Berkeley National Laboratory Lawrence Livermore National Laboratory .
Sandia National Laboratories / California Stanford Linear Accelerator Laboratory for Energy-Related Health Research Energy Technology Engineering Center Fusion Research Center i With apologies to Gertrude Stein:
"A rerrt is a rerrt is a reirt. "
Attributed to hilke Afobley and others. l l 2
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. : . w: .: : a. N : .m.n_L Berkeley Lab c Founded in 1931 - oldest national laboratory o f # ,- . w b r e.: o N trned after Earnest Orlando Lawrence,
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o Managed and operated by the University of California for the U.S. Department of Energy
. . l l
ERNEST ORLANDO LAWRENCE i BERKELEY NATIONAL LABORATORY i j 1 Presently Ernploys Over 3,200 People Occupies 134 Acres in Berkeley Hills Surrounded by UC Berkeley Elevation 500 to 1,000 Feet - Little or No Weapons Related Work l l University of California , The Regents of the University of California President of 1he University Ric hard Atkinson Berkeley San Francisco - Davis San Diego Irvine Santa Barbara Los Angeles Santa Cruz Riverside Lawrence Berkeley Lawrence Livermore Los Alamos National Laboratory National Laboratory National Laboratory LAWRENCE BERKELEY N AT4DN AL LAGORATORY 4 l
r ERNEST ORLANDO LAWRENCE BERKELEY NATIONAL LABORATORY ,
- Advance Light Source (Synchrotron) ,
a Bevalac/ Bevatron (Not Operating) Research Medicine (PET Accelerator) Heavy Ion Accelerator (Not Operating)
- National Tritiurn Labeling Facility I
Hazardous Waste Handling Facility 88-inch Cyclotron i U.S. Department of Energy A self-regulated safety program 1946 Atomic Energy Act established the AEC 1954 AEA amended to give AEC broad powers for peaceful purposes J
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1962 Kentucky was the first AEC Agreement State 1974 Energy Reorganization Act of 1974 split AEC into ) ERDA and created US NRC on January 1,1975 1977 DOE created as cabinet level agency replacing ERDA
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External Regulation of DOE 1990 . Clean Act Act Amendments extended NESHAPS (air emission stds.) to DOE sites 1992 Federal Facilities Compliance Act placed DOE sites under RCRA (hazardous waste disposal) Existing NRCIAgreement State oversight: , Gasseous Diffusion Plants Paducah KY, Portsmouth OH Spent Fuel Storage - Ft. St Vrain CO Offsite lab. Battelle PNNL - Richland WA , l 1994 9 Legislation introduced in the House to place DOE national labs under US NRC and OSHA l Drivers for External Regulation Safety Uniform standards consistent with industry Credibility Remove conflict of interest of self regulation; i open to external scrutiny Stability Predictable, resistant to political change 4 Aheame Commince,1995 Report of Advisory Committee on Extemal Regulation of DOE Nuclear safety i
.v.
ERNEST ORLANDO LAWRENCE BERKELEY NATIONAL LABORATORY Work Smart Standards Program Copper Release Study / Concurrence-DOE AIP Program Tritium Issues Work Group External Regulation Pilot (Phase I) , Eucalyptus Release Study / Concurrence External Ref alation Pilot (Phase II) EXTERNAL REGULATION 1995 Legislation Introduced in Congress Secretary O' Leary Convenes Advisory Committee on External Regulation 1 12/95 ACER Recommendations Published Secretary O' Leary Appoints Working-Group on External Regulation l 12/96 WGER Report Published I 7 i
i External Regulation cont. 9/97 DOE /NRC/RHB Begin Work on P,ilot Study LBNL Volunteered and Was Selected as First Pilot Project 11/97 DOE /NRC Sign MOU for Pilot Project Draft Report on Pilot Study Issued j 1 9 External Regulation cont. Congress Instructs Increased Involvement Phase II of Pilot Study i e
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1 More Effective Radiation Safety Management l
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'AEA. RADIATION NARM** PRODUCING MATERIALS MACHINES STATES Non-Federal Facilities , ,,,; ,,,,,,,,,,,y,,,
**NARM: Naturally occurring and Accelerator. produced Radioactive Material 9
o w External Regulation of DOE In the news ...
" Essentially all aspects of safety at DOE's nuclear facilities and sites should be externally regulated."
Advisory Committee on External Regulation of
- Department of Energy Nuclear Safety, Dr. John F.
Aheame,12-95 "The Department of Energy (DOE) will submit legislation to transfer oversight of nuclear safety to the Nuclear Regulatory Commission, Secretary of Energy Hazel R. O' Leary announced today." DOE press release, 12-20-96 External Regulation of DOE In the news ...
- "Mr. Chairman, the Depanment is ready to move forward now to work with you and others to develop a path forward to externally regulate single purpose Energy Research laboratories." Acting Secretary Betsy Moler before the House Science Committee,5/21/98 "many of the potential benefits that we expected to see from external regulation have not been demonstrated, and appear to be outweighed by associated costs and difficulties raised in the pilot projects." Energy Secretary Bill Richardson, letter to Rep. Ron Packard,2/19/99 1
10
1 "LBNL VIEWS. . ." l "LBNL agrees with the DOE Team , preference that LBNL should be regulated by the same regulators as private' industry and academia. LBNL believes that there would be a smooth and seamless transition to external regulation if the regulator was the State of California." L . l l "LBNL VIEWS . . ." l .
"LBNL considers that the benefits of external regulation are strongly dependent on the licensing model. LBNL believes that the onl'y license model that represents a clean break from DOE's self-regulation is the model in which UC-LBNL is licensed directly by the NRC or the State."
L 1 I1 i
4 ISSUES REGULATOR (S):- NUCLEAR REGULATORY COMMISSION OCCUPATIONAL HEALTH & SAFETY. ADMIN. CAL RADIOLOGIC HEALTH BRANCH CAL OHSA , 1 ISSUES cont.
. WHO WOULD BE THE LICENSEE?
U. S. Depamnent of Energy-The University of California Lawrence Berkeley National Laboratory 12
. 1
NUREG-1708 ONE HUGE DISAPPOINTMENT!
"WITH RESPECT TO STATE REGULATION OF DOE FACILITIES, l
SOVEREIGN IMMUNITY SHOULD NOT BE WAIVED AND THE STATES SHOULD t NOT REGUI, ATE DOE FACILITIES." j i 13 l l l
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CONTRADICTIONS This was not the conclusion of the LBNL site team from NRC.
-. This was not the conclusion of the DOE ,
Oakland Operations. - This was not the conclusion of LBNL. This was not the conclusion of the State of l California. t l Whose conclusion was it? 14
1 1 1 "I DON'T WANT TO REPLACE l ONE REGULATOR IN WASHINGTON WITH ANOTHER REGULATOR IN WASHINGTON." t l 1 1 l l OAS RECOMMENDS: . That the NRC aggressively seek regulatory authority over DOE and its contractor facilities. : 1 That the NRC include the regulation of DOE j contractor-operated facilities in the Agreement State program. 15
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