ML20206R550

Transcript of 990511 Acrs/Acnw Joint Working Group Meeting in Rockville,Md.Pp 1-103.Supporting Documentation Encl

ML20206R550
Person / Time
Issue date:	05/11/1999
From:	Advisory Committee on Reactor Safeguards
To:
References
ACRS-T-3078, ASB-300-775, NUDOCS 9905200150
Download: ML20206R550 (167)

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Ctcl^rvt ii Uj i,f d L AcesT-3078 '

, OFFICIAL TRANSCRIPT OF PROCEEDINGS NUCLEAR REGULATORY COMMISSION ADVISORY COMMITTEE ON REACTOR SAFEGUARDS

Title:

MEETING: ACRS/ACNW JOINT WORKING GROUP TE04 ( ACRS ,

RETURN CRIGINAL TO BJ'n'ri!TE

, M/S T-2E26 ~~

g F

415-7130

.nANKS!

Docket No.:

Work Order No.: ASB-300-775

/

LOCATION: Rockville.hfD DATE: Tuesday,h!ay 11,1999 PAGES:1 - 103 i

1

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1025 Connecticut Ave.,NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 9905200150 990511 307 PDR

1 1 UNITED STATES OF AMERICA I

.2 NUCLEAR REGULATORY COMMISSION

]

3 ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 4 ***

5 MEETING: ACRS/ACNW JOINT WORKING GROUP 6 ***

7 J 8 U.S. Nuclear Regulatory Commission 9 Two White Flint 10 Room 2B3 11 11545 Rockville Pike 12 Rockville, Maryland 13 Tuesday, May 11, 1999 l

i 14 l

() 15 The Joint Committees met, pursuant to notice, at 16 8:31.a.m.

17 MEMBERS PRESENT:

18 B. JOHN GARRICK, ACNW Chairman 19 GEORGE M. HORNBERGER, ACNW Co-Chairman 20 RAYMOND G. WYMER, ACNW 21 CHARLES FAIRHURST, ACNW 22 THOMAS S. KRESS, ACRS Co-Chairman '

23 GEORGE E. APOSTOLAKIS, ACRS 24 25 i

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2 1 STAFF PRESENT:

[ -

2' Andrew C. Campbell, ACNW Staff '

3. -Lynn Deering, ACNW Staff-4 Howard J. Larson, ACNW Staff 5 Richard K. Major, ACNW Staff 6 6 John Sorenson, ACNW and ACRS Fellow  ;

7 1

8 PARTICIPANTS:

9 Carl Paperiello, NMSS l

10 Seth M. Coplan, NMSS 11 12 13 1 14

() 15 16 17 )

18 19 l 20 21 22-23 24 25 1

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3 1 PROCEEDING

~

[V\ 2 [8:31 a.m.]

3 DR. GARRICK: Good morning. A little history in 4 the making.

5 This meeting will come to order. This is a 6 meeting of the Joint Working Group of the Advisory Committee 7- on Reactor Safeguards and the Advisory Committee on Nuclear 8 Waste. My name is John Garrick, Co-Chairman of the Joint

)

9 Working Group. On my far left is Dr. Thomas Kress, also 10 Co-Chairman of the Joint Working Group.

11 The Joint Working Group members in attendance are 12 George Apostolakis of the Advisory Committee on Reactor 13 Safeguards; George Hornberger of the Advisory Committee on

]

14 Nuclear Waste; and other committee members present are

() 15 Charles Fairhurst and Ray Wymer of the ACNW.

16 The purpose of this meeting is for the Joint 17 Working Group to discuss the NRC Staff's proposed framework 18 for a risk-informed regulation in the Office of Nuclear 19 Materials Safety and Safeguards. The Working Group will 20 gather information, analyze relevant issues end facts, and 21 formulate proposed positions and actions as appropriate for I 22 deliberation by the full Committees.

i 23 Richard Major is the Designated Federal Of ficial 24 for this meeting.

25 The rules for participation in today's meeting 1

.[

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l' have been announced as part of the notice of this meeting

( 2 previously published in the Federal Register on April 21, 3 1999.

-4 A transcript of.the meeting is being kept. As 5 usual, it is requested that the speakers-first identify 6 themselves and. speak with sufficient. clarity and volume so

'7 that they can be readily heard.

8 The Committee, the Joint Committee, the Joint 9 Working Group has received no written comments or requests 10 for time to make oral statements from members of the public.

11 As you know, the specific motivation for this 12 -particular Working Group was a recommendation from NMSS to 13 provide technical peer review of the Staff's future efforts, 14 to develop a framework for applying risk assessment methods D 15 to the regulation of nuclear material uses and waste 16 disposal.

17 I think that we will,-with that, get right with it 18- and ask Dr. Carl Paperiello, Director of the Office of 19 Nuclear Materials Safety and Safeguards, to begin.

20 DR. PAPERIELLO: Thank you. I am pleased to be 21 here today, and I would like to talk about risk-informed 22 regulation within NMSS. If I could have the -- why don't we 23 go on to the third slide. The second slide just says the --

24 an outline, to speed things up here.

25 In my view, what risk-informed regulation is about l

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5 1 is two pieces, risk assessment and risk management, and they 2' are two separate components of it, and in many ways somewhat 3 different.

4 Risk assessment is fairly scientific. Risk 5 . management has a great deal of political involvement. The 6 ' question is, if we know the risk, what is acceptable, and 7 that has been a target which has varied over the ages. If 8 we live in an era where people are starving to death and 9 suffering from infectious diseases, worrying about getting  ;

i 10 cancer when one is 70 years old is really not all that {

l 11 important. You may not live that long. )

I 12 To talk about the materials program, under the l 13 Atomic Energy Act we have identified more than 40 different 14 kinds of non-reactor activities, devices and systems that fs 15 are regulated by approximately 20,000 licensees.

16 Effectively in NMSS we regulate.everything the agency 17 -regulates with the exception of reactors, and even reactors 18 we get when they are in the final stages of decommissioning.

19 Most of the regulation we do, or most material in 20 the United States is regulated through the Agreement States 21 Program, not actually through NMSS. Now we argue about 22 volume of material, I have more curies than the Agreement 23 States because I have spent fuel. But in terms of numbers 24 of licensees, most of the licensees are in Agreement States.

l 25 The Atomic Energy Act, of course, provides for the ANN RILEY & ASSOCIATES, LTD.

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b

6 1 Agreement State Program. We have approximately 30 Agreement 1 i

(} 2 States with several more states, Pennsylvania and Ohio mest I 3 notably, likely to become Agreement States in the near 4 future. 4 5 Under this progrta we relinquish -- we don't

6. really delegate, we relinquish authority to the Agreement 7 States. The states have to have programs which are adequate 8 and compatible, obviously words which have a different 9 meaning to different people and always create a certain 10 amount of controversy. We have a program called IMPEP where 11 we assess all the programs to ensure that they are adequate 12 and compatible, and agreements can cover most areas of NMSS  !

13- regulation with the exception of high level waste greater 14 than Class C waste. Spent fuel storage, transportation, and

() 15 fuel cycle facilities. And states can decline to regulate 16 in certain areas. They can have partial agreements, which 17 happens. Some states choose not to regulate mill tailings.

18 Some states have returned to NMSS the sealed source and 19 devices program.

20 And also under the Atomic Energy Act, section 274 21 that provides for the states to become Agreement States, it 22 also has a provision which affects my program in that we are 23 to coordinate the development of radiation standards with 24= the Agreement States. So, therefore, when I want to change 25 my program -- for example, change the regulations in the l

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7 1- given area -- I have to consult with the Agreement States, 2 'and so therefore this is-not a sort of a dictated program,

[}

3 saying, okay, we're the boss. There is a certain amount of 4 give-and-take, and that creates, when we are trying to l

5 implement a risk-based, a quantitative -- this is what we 6 are really doing -- a quantitative risk base, we have always 7 had risk base within NMSS. It only has been qualitative and l I

8' has been based on judgment.

9 For example, we license big licensees out of the 1

10 headquarters. The smaller licensees are licensed out of the 11 regions. We have provisions for general licenses. We have 12 provisions for exempt quantities. So there is a graded 13 approach in licensing. There is a graded approach in 14 inspection. We don't inspect everybody at the same

() 15 frequency or the same level of effort. But it has not been 16 done on a quantitative basis in the past.

17 Next slide.

18 DR. APOSTOLAKIS: So let me understand this a 19 little better. If you want -- how do you make sure that the 20 states maintain an adequate regulatory program? Do you 21 inspect or -- DR. PAPERIELLO: Yes, we basically have a --

22 we have teams made up of Agreement State, NMSS and the 23 Office of State Programs staff. We visit them with a l l

24 frequency of once every two years to once every four,  ;

25 depending on previous performance. We take a look at their

]

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n 8

1- regulations, are they-up to_date. We-take a look at the 2 training and qualification of their licensing and inspection 3 staff. We review a sampling of their licensing activities I

~4 to see that the licensing work is done adequately, review a 5 sample of their inspection report to see that inspection 6 . reports are done adequately. We accompany Agreement State 7- license inspectors en some inspections again on a sampling 8 basis, and then we take a look at how the Agreement States 9 handle allegations, response'to events and when they have 10 programs for sealed source and devices or low level waste or 11 something like that, we look at -- we do the same thing for 12 those programs.

13 We then -- the report is written. There is a 14 management review board that is held for each of these

() 15 states. By the way, we do the regions the same way, same 16 program for the regions, too, except the regions are done at 17 a greater frequency. They do them every two years, l

18 regardless of their performance. From my viewpoint, they 19 work -- what they do is delegated from me, so I now have an 20 obligation to make sure that the resource expenditures are 21 reasonable, too. So there is a little twist with the 22 regions.

23 The management review board includes people like 24 myself, Karen Cyr, other senior managers of the agency, as H25 well as an Agreement State rep. So we review the report, O ANN RILEY & ASSOCIATES, LTD.

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1 9

l 1 .the state people have representatives there, and then we

(g 2 make a --you know, we put out a report on our decision, and

\s./  !

3 the findings of whether programs are adequate and i 4; compatible; also whether certain areas -- you could have a 5 case where the inspections aren't completely up to date. We 6 might turn around and make a finding-of satisfactory with 7 recommendations for improvement.

8 But, anyway, that's the program for the oversight 9 of the Agreement States.

10 DR. KRESS: Is there any concept in there -- I 11 almost hate to say the words -- below regulatory concern on 12 some of these things?

13 DR. PAPERIELLO: With respect to what?

14 DR. KRESS: Well, I suspect you choose a list of

() 15 16 things that you are going to have to license and regulate.

Do you choose --

17 DR. PAPERIELLO: Well, we do have exempt 18- distributions. I mean smoke detectors --

19 DR. KRESS: Okay, that would be one.

20 DR. PAPERIELLO: Yes, smoke detectors, luminous 21 dial watches, still the use of source material in certain 22 glasses; there's a whole list of exempt -- in fact, right 23 now we are reviewing all the exemptions because most of the 24 exemptions were made up years ago without a -- with not --

25 again, not as strong a quantitative view of risk as we now l

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10 1 have today.

2 DR. KRESS: So' risk might be the consideration one

(}

l 3 would use for those exemptions?

4 DR. PAPERIELLO: That's exactly -- well, that 5 would be the basis, but again, years ago, when many of these

.6 exemptions were written, we weren't as rigorous as we are --

I 7 I mean some of the exemptions that are written in the Part 8 40 were based on the fact they were uses thr.t predated the 9 Manhattan District. For example, glazes on dishes, uranium 10 glazes on dishes. That was something that went back, was in 11 the '30s. So when they wrote the original Part 40, they 12 made these things exempt. And the interesting thing, 13 because we are in the process, under direction from the 14 Commission, of' revising Part 40. In the original Part 40 O

I 15 they were exempt, but you couldn't manufacture them, and the j

16 reason is they wanted to save every gram of uranium for the 17 enrichment plants, and not waste it. That's my view of the ,

18 thing because it was very, very strange; you could watch the 19 evolution of Part 40 and the expansion of the exemptions and 20 the general license as uranium became more plentiful. So it 21 was not ---it was a national security issue, not a matter of 22 health and safety.

23 Let's talk about them. They vary widely. And 24 again, the way I put it, I regulate everything from the 25 production of luminous dial watches and smoke detectors to ANN RILEY & ASSOCIATES, LTD.

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~

11 1 spent fuel and strategic quantities of SNM; very drastic

./N 2 differences in the types of things that we regulate. l

'\) '

3 The hazard accident potential and failure modes 4 vary. Human error tends to be a very frequent cause of 5 system failures. Think about university research, where 6 very small quantities are used, people knock things over, 7 drop things, things boil over, so --

8 DR. APOSTOLAKIS: So when you say human error, you 9 think of university research?

10 [ Laughter . ] ,

I 11 DR. PAPERIELLO: Yes.

12 .[ Laughter.]

13 DR. PAPERIELLO: You know, a medicine 14 radiographer. Even irradiators, read anything, whether they

() 15 have to be by-product material or electronic sources, large 16 irradiators, most of the errors are human errors in 17 judgment, things like that.

18 We have -- in some systems we have a reasonable 19' amount of data on errors. In some other systems we have 20 almost no information.

21 For exair.pla. we know from experience that the 22 major cause of radiography overexposures is failure to 23 survey, but what percentage of the time do radiographers )

i 24 actually fail to survey? I mean I could draw a very simple )

25 -- and a very simple event tree exists for radiography 1

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12 1 overexposures. It's in one of the recent ICRP publications.

2 When I talked to one of the authors of that document, Don 3 Coo 3e, I said where did your numbers come from, and they 4 were guesses, because we don't know the data, we don't have 5 that information. And the communities vary in terms of 6 technical sophistication. They obviously vary very 7 differently from reactors, and the people sophistication 8 varies.

9 You know, fuel facilities will have regulatory 10 affairs managers who not only are involved with us but are 11 involved with the EPA and OSHA and other regulatory 12 agencies, down to small gauge users, engineering companies 13 who happen to use moisture density gauges and the like will 14 have somebody whose ancillary duty will be to take care of I

-15 the NRC license.

16 I have already -- one showed up'early in my 17 career, when I first became a section chief at a fossil l

18 plant that three years before had installed level gauges, i

19 and when we showed up with this license, what license? And

'20 eventually, of about five or six users named on the license, 21 there was one that was still at the plant. So it was a --  ;

22 you know, that --sophistication varies significantly.

23 In some cases NMSS in the past has given explicit 24 consideration to risk. The -- we have incorporated an old i

25 EPA standard that's no longer valid into the Part 60 that i

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13 1 required that the risk curve for releases of radioactivity 2 from proposed geological repository meet certain limiting 3 criteria. Now we know that's not the standard any more, but 4 at one time we did.  !

5 Secondly, we are in fact using risk when we set 6 radiation dose limits. However, we don't always recognize 7 it explicitly. For example, when we set a limit of 25 8 millirem per year for the average member of the critical l

9 population group for high level waste repository, we in fact 10 have set a risk standard because one can use the linear dose 11 model and translate that into risk, and we could argue, i

12 well, we don't like the linear model. But the practical I l

13 matter is on the reactor side, when you are looking at l 14 latent cancers, you are using a linear model. And the r

(3) 15 agency in -- and I don't remember the NUREG any more -- back 16 in around '86 or '87 endorsed not only the linear model but 17 endorsed certain of what we now call slope factors. And the 18 ones we use today aren't a whole lot different than what's ,

19 in that NUREG.

20 And, in fact, when you use $2000 per person rem, 21 you are in fact using the linear model. So we -- and I 22 don't want to get in arguments of whether the linear model 23 is valid at 25 millirem per year -- my personal believe is 24 it isn't, but the practical matter is that's what we do --

25 and so, therefore, you are in fact having -- establishing a

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14 1 level of acceptable risk.

~

2 Since the mid '70s, we have pursued PRA, 3 probabilistic -- I shouldn't say PRA, because that's one 4 thing I'm trying to -- if there's one campaign I have, I'm 5 trying to establish the idea in everybody's mind that risk 6 assessment and PRA are not the same thing. PRA is one of 7 many techniques for doing risk assessment, and it may not be 8 applicable to every area that we regulate in NMSS, but in 9 particularly performance assessment for waste, whether it's 10 high level waste or low level waste or decommissioning, or 11 the transportation, the publication we call the Modal Study 12 essentially is a PRA applied to severe accidents in 13 transportation.

14 DR. APOSTOLAKIS: I think we should clarify the

() 15 use of the acronym PRA. From the way you describe it, I 16 think you mean risk assessment as applied to reactors.

17 Because PRA, in my mind, is really a conceptual _ approach 18 that is applied in a certain way to nuclear power reactors 19 in a different way, but conceptually the same, to high level 20 waste repositories. So it seems to me that the use of 21 language, since we are beginning this now, is very important 22 and we should agree on what we mean by PRA and what we mean 23 by other things.

24 In other words, are PRA and performance 25 l assessments fundamentally different, or they differ in the I

i

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15 1 tools that they use to implement the same concept?

2 DR.'PAPERIELLO:

({ I think it depends on your 3 definition of PRA.

4 DR-. APOSTOLAKIS: I know. That's why we should 5 agree on a definition.

6 DR. PAPERIELLO: That's why I would just like to 7 say risk assessment and then recognize that some of my risk 8 assessment could be purely actuarial. Because in my side of ,

9 the house, I have a lot of actuarial data. I have data all 10 the way to the severe consequence. I know -- I have 11 empirical data on what happens when radiography sources get 12 loose, both in injuries and death to radiographers and J 13 injuries and death to members of the public, at least on a j 14 worldwide basis. So, you know, there are some differences.

15 Now I --

16- DR. APOSTOLAKIS: Go ahead.

17 DR. PAPERIELLO: I'm not a practitioner of any of 18 these things. I'm sort of a -- you know, at my level I'm 19 sort of just a -- I'm a physicist by background, so I --

20 it's --but we're looking at it, at least within the agency.

j 21 PRA is a very, you know, a bunch of event trees, you have 22 your fault trees, you have data from mechanical failures, 23 and I deal with a number, and the differences I see cetween 24 performance assessment and probabilistic risk assessment is 25 at the various Ts, or your various points where things come

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p 16 1 together, you use binary values in PRA for each of these, 2 where we use distributions in performance assessment, at

)

3 least. And I may be wrong. I'm telling you as a person who 4 is not a practitioner of any of these methodologies what it 5 looks like from the outside in.

6 DR.. APOSTOLAKIS: I don't think it's a matter of 7 being right or wrong. It's a matter of convention, really, 8 of language, and maybe that should be one of the first 9 issues that this subcommittee takes up, to agree on the 10 language.

11 DR. GARRICK: Yes.

12 DR. PAPERIELLO: If you look at the American 13 Chemical -- American Society of Chemical Engineers books on 14 integrated safety assessment, you will find PRA in that

() 15 16 paradigm as a subset of ISA, okay? So it's the most' quantitative, you know, version in there, but the PRA then 17 becomes a subset.

18 DR. APOSTOLAKIS: No, I know that there are 19 different -- and also they call it QRA, quantitative risk 20 assessment. So I think before we go into more detail of 21 these things, we should agree on the language, perhaps not 22 right now, but certainly our letter should say something 23 about it.

24 DR. GARRICK: Yes, the language is a major part of 25 the problem, and you are right, there's actually three O ANN RILEY & ASSOCIATES, LTD.

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o 17 1 acronyms that are used internationally that really mean the

(')

V 2 same thing, and they are PRA, QRA, and.PSA, with 3 probabilistic safety analysis being the preference of the 4 international _ community for PRA, and PRA being pretty much 5 an NRC acronym, and ORA being the preference of the space 6 industry _and the chemical industry, simply because they 7 don't like PRA. So -- but they all really are talking 8 pretty much about the same thing.

9 I would agree with one thing, that risk assessment 10 is something that is rather fundamental, and I think there 11 is agreement pretty much on what we mean by a risk 12 assessment. I would not necessarily agree that when I think i

13 of PRA, for example, I necessarily associate with it fault 2 14 trees and event trees. I think that's a detail. It's like 15 saying where do you get your probabilities from, and some 16 people say MONTE CARLO. You don't get probabilities from 17 MONTE CARLO. MONTE CARLO does the probability arithmetic.

18 It does not generate the fundamental probability. So I 19 think a way to get to this issue of language is maybe to 20 think in terms of very basic definitions, and then go from 21 there. And you're right, it's a big subject and we need to 22 evolve to it.

23 DR. PAPERIELLO: Okay. Well, in any case, when I 24 use probabilistic risk assessment, I use it within the 25 framework of what we do in this agency for reactors, and ANN RILEY & ASSOCIATES, LTD.

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18 1 from my view it works extremely well in mechanical systems;

/}

2 not just mechanical, but complex systems, many interact as

.v 3 -- again, I'm saying from the outside in,'I have a system 4 that should not fail, yet it fails, as-multiple redundancies

-5 and all that kind of stuff. I have a lot of systems that I 6- regulate with almost no redundancy, or the redundancy are 7 . human -- are procedures and human barriers.

8 What we are looking at and the subject of our 9 paper is we have identified sets of risk assessment 10 techniques that we believe cover most of the things we do in 11 NMSS. This is something we did not really have identified a 12 couple years ago. We believe that using performance j

13 assessment is effective for dealing with waste disposal' 14 systems.and decommissioning. The set of techniques that are

() 15 ' encompassed by integrated safety analysis, at least as 16 defined by the chemical industry, is an effective tool for 17 analyzing fuel cycle facilities and perhaps some l 18 transportation. And hazard barrier analysis is being 19 developed for the multiplicity of systems that we regulate 20 in what we call our materials program, but basically through 21 Parts 30 through 39 and some of the manufacturing and 22 non-fuel uses of source material.

23 We want to increase our use of. risk assessment.

24 The current revision of Part 70 will require a fuel

. fabrication and enrichment facility to perform integrated 25' O ANN RILEY & ASSOCIATES, LTD.

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l 19 l 1 safety analysis'. Actuarial methods are being considered for

} 2' our various material uses,_ byproduct material uses, where we 3 have large sets of data that involve many similar licensing 4 systems. We now have responsibility for the nuclear 5 materials events data base, and we gather data not only from 6 NRC licensees, but also from Agreement State licensees. And 7 we are'looking for simple predictive risk analysis methods 8 for our simple systems.

9 The Commission has directed us to develop a )

10 framework for the use of risk analysis and decision-making, 11 and of course we discussed this in 99-100. The problem is 12 -- okay, and we now have risk -- let's suppose that we have l 13 a risk assessment technique, or we have -- we can cover most 14 of our -- the things that we regulate with some kind of O 15 quantitative or semi-quantitative risk assessment, what

( j 16 should be our risk goal?

17 I think it's important to define a safety goal for 18 NMSS. And I call it the problem of the. target. The -- who 19 should be the target? I could pick a goal. I'll make a 20 number up, one in a million. Everybody assumes that one in 21 a million is negligible, at least for the society that we 22 have today. I assume if we lived forever, the probability 23 of death in an accident like automobile accidents would be 24 considered completely unacceptable. But as a practical 25 matter, the automobile death rate shortens the average life

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l; I'

20 1 span in the United States for about a year or so out of 70 2 something years. I assume if we have much longer life

(

)

3 spans, it would be a bigger -- natural life spans, it would 4 be a bigger number and we wouldn't find that acceptable any 5 more.

6 But the question is, what's the target? If the 7 entire population of the United States is the target, you 8 know, if I use 10 miles around every materials facility, I'd 9 probably blanket the country. That would mean I could 10 accept 270 deaths a year, or a half a million person rem. .i 11 And any estimate of dose to the American population from 12 things that I regulate, putting aside medicine, is probably 13 only on the order of a couple hundred, perhaps a thousand, 14 person rem. So I mean drastically higher exposures than .

() 15 now.

16 If you turn around and make it no one individual 17 .is going to be given a risk of 10 to the minus 6, you are 18 -going to be dealing with limiting the public dose to 2 i

19 millirem a year. So the question, I see as a major function I 20 defining my target for a given practice that I regulate. ]

21 So the reactor safety goal, at least as written, I 22 is not applicable. I i

23 There's the matter of cost / benefit. Now, 1 24 remember, I put aside medicine, and it's clear in the j 25 regulation of medicine, we allow a lot higher exposures, and ANN RILEY & ASSOCIATES, LTD.

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21 I we don't even -- and I'm putting aside the patients. We are 2 talking about patient release criteria right now of 500 (G)

3 millirem to a member of the public, we assume mostly family, 4 because the person who would get the treatment was presumed 5 to be suffering from cancer, and probably be returned to a 6 family environment.

7 We have petitions for rulemaking which would allow 8 visitors to patients undergoing implant therapy or 9' radionuclide therapy to get doses up to 500 millirem, at the 10 same time we are setting dose standards of 25 millirem a 11 year for high level waste. So I'm just saying -- and it's 12 estimated by NCRP that the release of patients with --

13 having undergone diagnostic procedures is rough? J00 14 person rem a year, NCRP 1.24, and that would give you, if

() 15 16 you used the linear dose model collective dose and put aside all the things which I don't believe, to about four deaths a 17 year, four induced cancers from patients being released --

18- not to the patients, but to members of the public.

19 So clearly cost / benefit comes into the thing.

20 Medicine gets a wide degree of latitude because it's 21 presumed to benefit -- be of great benefit to the patient.

22 So, anyway, this is an issue. So we are 23 interested, we are very much interested in when the agent 24 being included in any agency effort to establish a safety 25 goal for the agency and a decision needs to be made whether

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e- l 22 1 or not there is going to be either consistent with the

.2' reactor safety goal, which effectively is going to be a 3 question of who's defining who to target, or else just 4 having multiple safety goals for materials. You know, 5 decommissioning safety goal will be different than an '

-6 operating safety goal. Just as long as there's a decision.

7 Because'the question is then how do I use risk-informed 8 regulation? What am I --

at what point do I stop 9 regulating.

10 DR. APOSTOLAKIS: Are you going to ask the 11 Commission to consider --

12 DR. PAPERIELLO: I'm sorry?

13 DR. APOSTOLAKIS: Are you going to ask the -- or 14 suggest to the Commission that they should consider

() 15- establishing safety goals for material uses?

16 DR. PAPERIELLO: Yes. I mean this is part of --

17 you know, what we've had -- this is our second -- 99-100 is 18- our second paper on the topic, and we are progressively 19 moving, you know, moving down. Because I think we have L20 established now'a good sweep of risk analysis techniques.

21 I'm in the process of forming a group within IMNS 22- that will deal with risk assessment. In other words, I 23 don't -- I have practitioners for some of these techniques; 24 I don't have practitioners for all of them; and I need a 25 group that can use all the tools we are relying on for some 1

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23 l

1 things.on contractors right now.

2 As I pointed out, we have -- we don't have a lot

(}

3 of uniformity in materials. We have different degrees of 4 sophistication in different users. We have incorporated 5 risk in varying degrees. I think we'are moving -- what we 6 want to do is move to greater rigor. The technique we 1 7 choose has to be appropriate to the technology we are 8 regulating. We think'what we are doing -- we are trying to l 9 accomplish -- to use things which are analogous to the 10 reactor regime, and I guess we are looking to this committee 11 for, you know, advice and recommendations on the proposals 12 that we have, you know, offered up to the Commission.

13 DR. GARRICK: Questions for Carl? George? Tom?

14 DR. KRESS: Well, I agree with you that the

() 15 primary need before you can do what we are trying to do is 16 to have targets. I call them acceptance limits on l

l I

17 regulatory objectives. And I also agree with you that 18 safety goals for reactors are not goir.g to be very useful to l

19 you, but when you get around to setting these, I think you u 20 will have to come up with some sort of common metric for all 21 of these different things. And it seems to me like the 22 common metric is a cost / benefit. Somehow you need to decide 23 what your target cost / benefit is, and then figure out how to 24 set the goals based:on those, and I would -- you know, there I'

25 should be a concept in there of lives saved are worth more ANN RILEY & ASSOCIATES, LTD.

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l, 24 1 than statistical lives lost, especially in the medical

(~)

G' 2 field, when you do the cost / benefit. But I do think that's 3 where the biggest problem is going to be.

4 DR. APOSTOLAKIS: But I think there are some uses, 5 though, where there are other dimensions of risk that become 6 important, and one that comes to mind is the distinction 7 between voluntary and involuntary risk. I mean can we 8 really dictate to somebody what his life or her life is 9 worth? And when it comes to medical uses, as you pointed 10 out, that's different.

11 DR. PAPERIELLO: Right. And of course, that's the 12 basis between public dose limit and worker dose limit. To 13 my mind, the essence of occupational worker is informed 14 consent to the higher risk.

I

[G 15 DR. APOSTOLAKIS: Yes. Well, I actually had a 16 question. I forgot. It's really a comment. In the reactor 17 arena, as you pointed out, the regulations have been 18 risk-informed from day one, it's just that risk was not 19 quantified, and what drove us to the risk-informed approach 20 is that in the last 25 year we made significant progress in 21 quantifying risk, PRA, you know, since '74, with the reactor 22 safety study and all the other studies that followed. So 23 there is a driver there.

24 Now it seems to me in your case, the driver is 25 still the reactor side, because you have not -- have you T- ANN RILEY & ASSOCIATES, LTD.

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s_, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034

25 l 1- really made the same advances in quantifying risk in the 2 last 25 years, or are you just being forced to consider 3 risk-informed regulation because the other side is doing it i 4 and the agency wants to have a uniform approach to things?

5 DR. PAPERIELLO: I think it's a combination. I 6 think it's-a combination. I think we never thought about it 7 in some areas. In other areas we were forced to, we had to 8 do it when we started dealing with, you know, waste.

9 DR. APOSTOLAKIS: Sure.

10 DR. PAPERIELLO: We did it for transportation

]

11 because transportation, at least the rules up to now, Part )

12 71 has been based on international standards, they have been 13 based on international consensus that was deterministic.  !

14 And the question came down to us, okay, I test a Type B )

1 15 package by burning -- by having a certain temperature fire 16 for a period of time, submerging it in water and dropping it l 17 and all that. Well, then you get the -- okay, what happens l 18 if this canister is crossing the Mississippi River and winds 19 up going into the Mississippi River or falls down the Grand ,

20 Canyon gorge, you know. We can all make up accidents. So 21 back in the '80s, we did the modal study to look at what 22 would be the equivalent of severe accidents for packages, 23 and we defined a set of risks, and spent fuel is the issue 24 that has driven that.

25 I think in the balance of what we have done, we ANN RILEY & ASSOCIATES, LTD.

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26 1 are being driven to be more quantitative. On the other l

2 hand, when you look around, you turn around and say why not?

i ()i

\.

l 3 It's just been ignored. And, in fact, when you start l

l 4 looking for techniques, you find the techniques. The 5 chemical industry was driven to use ISA because they 6 couldn't tolerate severe accidents with chemical plants like 7 occurred in Bhopal in India, and some other accidents they 8 had. But the question comes down to, when you can cover a 9 certain amount of area, you are going to find -- in my view, 10 I find it attractive, is asking why we have a given 11 regulation, you know, in a given area.

12 I have been around about almost 25 years in the 13 agency, and I have seen singular events lead to significant 14 changes in a regulation. So we have an event and we wind up y

l

• 15 changing the regulations for one event. I'm talking about G

i 16 on the material side. We know about Three Mile Island and 17 what happened after Three Mile Island, but you turn around, 18 and now -- that's no consideration of probability. It was 19 based on consequence. I mean risk the probability of an 20 occurrence times the event. So you have one event, it's l 21 serious without considering the probability of it occurring.

l 22 We have revised the rules. And so the question now is, is l 23 do we need -- is explicit consideration of the risk.

l 24 But once you explicitly consider the risk l

l 25 assessment, you now have got to ask what's your risk

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27 1 management. Because what you did in the past is you blended

() 2 3

the distinction.

going on.

My assertion is that some of that is still 4 When I asked at the Seville conference about a 5 year and a half ago, the ICRP what their -- when they made a 6 statement.about acceptable risk, what the scientific basis 7 was, they said they didn't have any. So whereas a lot of 8 the conference was devoted to risk assessment, and they 9 talked about their standards, when you took the risk 10 management piece of it and you started delving into it, they 11 didn't have a good basis. It was an assertion. And so now 12 -- and so in my mind, I have been very conscious of the risk 13 management because it's a -- it's not a completely 14 scientific decision. It's a decision that's going to be --

(s_ )- 15 society's going to make a distinction what the risk is.

J 16 For example, the statement the difference between 17 voluntary and involuntary risk. Why? Psychologically I 18 understand it, but the end state is the same. You know.

I 19 But I'm just saying it's -- but, see, that's my whole point, 20 it's a -- and we recognize it in other cases. I would j l

21 assert that many of our voluntary risks are not voluntary at

-22 all. If I want to work, I have to drive a car, so I mean I  ;

23 would assert a lot of our voluntary risks are not voluntary.

24 DR. KRESS: But you recognize, of course, that you 25 always end up in this business with this input, that society ANN RILEY & ASSOCIATES, LTD.

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28 1 -- that you don't have a technical basis for those risk l (m)

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2 acceptance levels.

3 DR. PAPERIELLO: Oh, I well --

4 DR. KRESS: Yes, they always have to be fixed some 5 way and it's mostly societal judgment type thing.

6 DR. PAPERIELLO: Oh , I understand that, and I 7 recognize it in a democracy, and it's an incredible societal 8 judgment. And I don't think that's wrong. I'm just saying 9 you need to -- as a regulator, I need to recognize -- I need 10 to be very conscious in what space I'm in when I deal with 11 risk, that management of risk is a very different animal 12 than assessment of risk.

13 DR. GARRICK: There are a couple of things that 14 kind of impact my thinking based on this discussion. One is

() 15 that it seems that whatever direction we go with materials, 16 there ought to be some connections with what we have done in 17 the past including what we've done in the reactors.

18 MR. PAPERIELLO: Sure.

19 DR. GARRICK: In other words, the logic has to be 20 there. If we are talking about a safety goal for materials, 21 somehow there has to be a nexus between that safety goal and 22 the reactor safety goal, given the overall responsibility of 23 the Agency. And maybe that is the idea that Tom was getting 24 to with the cost-benefit concept. There has to be 25 something --

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r:

29 1 MR. PAPERIELLO: I understand.

f '2 DR. GARRICK: That bridges --

3 MR. PAPERIELLO: Let me --

4' 'DR. CARRICK: That bridges across these things in 5 order to assure the public that-the.NRC --

6 MR. PAPERIELLO: Right.

7 DR. GARRICK: Is not ad hoc already doing this, 8- 'that there is consistency in their view of.how safety should 9 be-regulated. That's one point.

.1 -0 MR. PAPERIELLO: I would say I would agree with 11- you emotionally,;but on the logical level I'll puint out we 12 don't do it in the-United States.

13 Let me point out transportation. If I recollect, 14 and don't hold me to the year, I believe the Department of

-( ) 15 Transportation's safety goal for the United States, under 16 GRPA, their outcome indicator, is 43,000 17 transportation-related deaths in the United States for '99.

18 Don't hold me to the year; I don't know, '98, '99, or the 19 year 2000, something-like that. Now obviously in a split 20 mostly with automobiles and very small for aircraft, and 21- rationally we all accept why-shouldn't we have the same 22- safety goal for automobiles as aircraft? Yet we don't, 23 because we all know that aircraft mile for mile is a lot 24 safer.

/ 25' Why don't we have the same safety goal in the I\ ANN RILEY & ASSOCIATES, LTD.

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g l-L 30 1 United States for my view, my side of the house, t

2 technologically enhanced natural radiation as Atomic Energy 3 Act and we don't? I'm just saying emotionally I agree with 4 you, we ought to have the same safety goal for the both 5 sides of the NRC house, and I kind of endorse that. Yet I 6 recognize that's not true for many comparable risks in the 7 United States.

8 DR. GARRICK: But to get to that, we don't want to 9 set the example of not being able to --

10 MR. PAPERIELLO: I understand that. I'm just --

11 DR. APOSTOLAKIS: But it seems to me, though, 12 again it's a matter of language, when you say comparable 13 risk, you mean comparable numerical values, but risk is 14 multidimensional. The numerical value is one aspect of it.

(. ,) 15. We talked about voluntary / involuntary controllability of 16 risk, for example. That's perhaps a better argument, that 17 rpen you drive your car, you feel that you're controlling 18 your fate.

19 MR. PAPERIELLO: Let me --

20 DR. APOSTOLAKIS: So the numerical values do not 21 necessarily have to be consistent with each other, because 22 there are other dimensions that make us use different 23 numerical values. But I would agree with Dr. Garrick that 24 we have to agree on the basic philosophy. The philosophy i 2 5 -- can be the same; the: approach, the conceptual approach, can

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31 1 be the same among the various offices of the Agency, even 2 though the particular' implementation may differ-in terms of 3 numbers or how we do things. So we have to go to a higher' 4 plane, I think.

5 DR. KRESS: And to expand on that just a bit, I 6 think George would say a risk analysis by any other name is 7 still a risk analysis.

8 DR. APOSTOLAKIS: It's like a rose.

9- DR. KRESS: Yes.

10 MR. PAPERIELLO: As I said, there's risk analysis, 11 and then there's risk management. They're two very, very 12 different animals.

13 DR. APOSTOLAKIS: Yes.

14 DR. KRESS: Oh, I agree with that certainly.

() 15 MR. PAPERIELLO: Let me make an observation about 16 reactor risk. When you look at risk over a ten-mile radius, 17 if we truly had a metric system and we used kilometers, 18 would we have chosen the risk over a 16-kilometer radius or 19 would we have rounded it to 15 or rounded it to 20?

20 DR. KRESS: It doesn't matter, and the reason is 21 is you fixed your acceptance criteria that you have for that 22 risk in conjunction with that number. So, you know, you can 23 make it smaller and make your acceptance value smaller; make 24 it bigger, make the acceptance values bigger. You can 25- balance those things off.

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i t -- j

32 l

1 DR. GARRICK: In fact, from a risk assessment,

{

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) 2 there have been a number of studies done that indicate that l 3 if you want to do it on a PRA basis, it's probably not 10 4 miles, it's probably a couple miles, because 95 percent of 5 the fatalities are within -- on a large early release are 6 within a mile or mile-and-a-half. So that right, you pick 7 the number, and then -- the other point I wanted to make was 1

8 I think that in the materials area we do have an advantage, 9 and that is to take note of all the mistaker that have been l 10 made in the past, and to try our best to avoid them.

11 One of the things in that regard that I think we 12 want to focus on is the matter of simplicity. Is there a 13 way to keep this process from going exponential in terms of 14 process? l O.

15

( -)

So the lessons learned from the safety-goal 16 experience on the reactor side is critically important here.

17 There's a lot of people in the industry that would argue 18 that there are no safety goals in the reactor side either, 19 because they're not implemented rigorously. The core damage 20 frequency has kind of come into use more in a use basis than 21 an actual requirement basis. And there are those who would 22 even argue thac the safety-goal idea is not particularly 23 logical because it is a single-attribute concept. It is a 24 speed-limit mentality, and we all know that everybody that 25 stays within the speed limit is not necessarily safe, and ANN RILEY & ASSOCIATES, LTD.

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33 ,

1 everybody that exceeds the speed limit is not necessarily j 1

2 unsafe, that.maybe what we should be adopting here is more ,

3 of a decision framework, that is to say, the choice between 4 alternatives. .

i 5 And so I think all I'm saying by this with respect 6 to.my second point is that we ought to be darn careful here 7' to make sure that indeed.we do want a safety goal, because 8 the experience with the safety goal in some people's minds )

9' has not been all that reassuring, primarily because it 10 hasn't really been implemented.

11 MR. PAPERIELLO: That may be the case. I wouldn't 12 want to -- I don't have enough experience on that side of j l

13 thinking about it. When I was on the reactor side I dealt 14 with the implementation of the program in the field and not I

~

15 the more-philosophical or regulatory interpinnings here in 16 headquarters. I do know in the <n.a of what I regulate I am 17 looking for some way of bounding what we do. You just can't 18 keep, every time something goes awry, adding another 19 requirement.

20 DR. GARRICK: That's right. l 21 MR. PAPERIELLO: For one thing, somebody can't 22 keep track of all the rules in the rule book. That's part 23 of my problem. I mean, one of the things we're doing when 24 we're revising all of our licensing guidance is to keep 25 things simple. Because I deal with a lot of entities, you O ANN RILEY & ASSOCIATES, LTD.

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r-34 1 1 know, gauges, what five things do I need to know about my

)

2 gauge? You know, don't put your hands on the source, you 3 know, keep it locked up when you're not using it, if it gets 4 damaged, don't abandon it. I forget what the other two 5 things are, but you can do it very, very -- keep it very, l 6 very simple.

7 I think in some cases for a lot of my licensees if 8 I could keep the rules on one of these cheat sheets. You 9 know, I used to play bridge years ago, and you get a plastic 10 bidding convention that was on a sheet of plastic and read 11 both sides. If you keep the rules on something like that, 1

12 for many of my licensees that's about as much as they can 13 remember or refer to. And it's better to have a handful of 14 reliable rules'rather than a whole bunch of extra little

() 15 things that people will never follow because they're going 16 to forget it.

17 Again, it has to be gauged to the sophistication 18 of the licensee.

19 DR. GARRICK: George..

20 Dh. HORNBERGER: Is it important to have the 21 Agreement States on board as you do this, and if so, what 22 are you doing to --

23 MR. PAPERIELLO: Well, it would be nice to have 24 the Agreement States on board, and of course what we do when 25 we write -- for the last several years, at-least since I've ANN RILEY & ASSOCIATES, LTD.

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35 i

L 1 been in charge, every time we have a rule revision, when we

[)

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2 revise all our licensing guidance, and in some cases when we 3 revise our inspection procedures, we have working groups, 4 and we include Agreement State people on the working group.

5 But the Agreement States are clearly not where we are in 6 terms of quantitative risk assessment in, you know, in 7 regulation.

8. DR.'APOSTOLAKIS: I assume we'll come back to the 9 issue of risk assessment when we talk about the framework.

l 10 DR. GARRICK: Yes. Yes. I guess we have another l

11 presentation to do. Yes. Yes.

o 12 Are there any other questions for Carl? We really 1

13 do appreciate your spending the time with us, Carl.

14 MR. PAPERIELLO: Glad to be here.

() 15 DR. GARRICK: Yes. Okay? All right. Thank you.

16 Seth, I'll let you introduce yourself and your 17 topic.

18 MR. COPLAN: Good morning. I am Seth Coplan. I 19 am in the Division of Waste Management in the Office of l

20 Nuclear Materials, Safety and Safeguards, and I am the i 21 contact on the paper that is kind of the main part of the l

l 22 discussion here this morning.

23 What I would like to talk about is, first of all, l 24 some background, how the paper came to be written, what its 25 purpose is, then I would like to spend some time taking ANN RILEY & ASSOCIATES, LTD.

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4 36 1 about risk assessment, starting with risk assessment methods

[~)

%j 2 that we have used in the Office of Nuclear Materials, Safety j 3 and Safeguards and what associations we believe can be made 4 overall within the office between such methods and the 5 things we regulate. Then I would like to turn to the topic 6 of risk management and with all of that in place, we can 7 talk about the framework and the need for stakeholder 8 involvement as we implement it and finally how this links 9 with the PRA Implementation Plan.

10 Obviously there is a lot of material there and I j 11 am going to try to move along but will be happy to answer l 12 any questions as they come up.

1 13 Basically the paper had its origins in the 14 strategic planning effort that the Commission went through a 1

()

y 15 couple of years ago. One of the issues that the Staff l

16 identified, that it looked to the Commission for policy 17 guidance on, was something called risk-informed and 18 performance-based regulation.

19 In 1997 on April 15th the Commission issued a 20 Staff Requirements Memorandum, an SRM, that gave direction 21' on this broad topic. Most of it was directed agency-wide.

22 A very substantial portion of what was not agency-wide was I l

23 directed towards reactors, but there was one paragraph in 24 particular that was focused in the materials area, and there 25 were basically three things that it brought up. l r

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37 1 First of all, it asked us to review the n

2 risk-informed and performance-based approaches that we had

(

3 in the high level waste area and in the industrial and 4 nuclear medical areas to assure that the needs of those 5 licensees were receiving adequate consideration.

6 Secondly, it asked that we review the bases for 7 our materials regulations to identify areas that could be 8 made amenable to either risk-informed or performance-based 9 regulation with minimal incremental resources.

10 Finally, we were asked to develop a framework for 11 using risk technology in materials regulation that would be 12 similar to the framework that was developed for reactors and 13 provided to the Commission in I think it was SECY 95-280.

14 We provided a preliminary response to the SRM in

( ) 15 SECY 98-138. The purpose of this paper was to address 16 several commitments that we made in SECY 98-138, which I 17 will get into in a minute, and to request that the 18 Commission approve, first of all, a proposed framework, 19 secondly, our approach for addressing risk management l

20 issues, and in particular the approach that we were going to 21 take or were planning to take to develop risk metrics and 22 goals, and finally Commission approval of the formation of 23 this subcommittee, because we thought we needed to have some 24 means of getting good technical peer review on this.

25 In SECY 98-138, we committed to develop or to

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38 1 scope the development of a framework, and estimate the

() 2 resources that it would take to do it, make recommendations 3 to the Commission on how we were going to proceed from 4 there,'and I probably ought to explain one thing there. In 5 SECY 98-138, the proposal that we had for developing a 6 framework was really going to be a pretty drawn-out, 7 cumbersome process that would have brought the Agreement

/

8 States in and lots of stakeholder interaction just to 9 develop a framework.

10 When we got together as a task group, which was 11 part of what we said we were going to do, it came out pretty 12 quickly we were over-cooking things and that the reactor 13 framework was really a fairly high level, logical structure 14 that was Just intended to make sure that all of the right  !

() 15 bases got touched and that even with the more complicated 16 situations that we have in terms of the variety of )

l 17 activities it would be possible to come up with a fairly 18 simple framework analogous to the reactor framework, and so 19 we ended up doing that.

20 We also committed to making an association of risk 21 assessment methods with the regulated uses of materials and 22 disposal, and finally, to make some preliminary

{ 23 identification of how we might use risk-informed approaches 24 in materials regulation.

25 We also committed to re-examining what activities i

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39 I

l 1 we had listed in the materials area in the PRA l

! l 2 Implementation Plan from the standpoint of are these 3 consistent w'ith the framework with the approach that we are .

4 planning.

5 I would like to turn now to risk assessment in  !

6 NMSS. I think that in the talk that Carl gave it started to 7 come out that we have been involved in risk assessment in 8 the materials area for a pretty long time actually. We 9 started developing performance assessment back in the middle 10 to late 1970s in part because a risk-based or risk type of 11 approach seemed to be the only reasonable way to account for 12 the kinds of upset conditions that might affect a repository 13 over the long period of interest that was involved, and so 14 we got involved in a number of activities within the United

() 15 16 States and international activities that led to the development of the performance assessment methods that are 17 in use now.

18 Carl described earlier how we got into applying 19 risk methods to transportation. Some time later we got into 1

20 a concern about accidents at some of the fuel cycle l 21 facilities that were kind of unanticipated and again look to 22 system analytic approaches that might help to ferret out 23 things like that before they happen and we became interested 24 in integrated safety analysis.

25 My point is that over a period of-time, we picked i

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40 1 up techniques or developed them as they seemed to be

['*}

Y 2 applicable and needed and when we started to look more 3 carefully at what we do in the office in connection with l

l 4 this paper, it struck us that really we deal in one sense )

1 I 5 with four types of activities.

6 We have got activities that involve a long-term 7 presence of nuclear material at a site at some planned 8 level. This is high level waste disposal, low level waste 9 disposal, and decommissioned facilities where some 10 contamination is left at the site so that people would have 11 exposures that are within the Part 20 limit and no more than 12 that.

13 The second broad area are activities that involve 14 casks to keep material from exposing people, and the casks f( ) 15 then need to be protected. We use them for shipping, use 16 them for storage of spent fuel.

17 The third type of activity is physical and 18 chemical processing of materials. It includes things like l 19 enrichment, fuel fabrication. We think of the preclosure 20 activities at a high level waste repository as falling into i

21 that category.

22 Finally, there is just an almost remarkable 23 variety of activities that involve the use of byproduct 24 material in industry and medicine, and what we found is, not 25 surprisingly, performance assessment is a good tool for the l

\

(/

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41 1~ first group. Should be -- it was developed for one of the 2 principal areas in that group.

V()

3 Secondly, we found that PRA and ISA both seemed to 4 work pretty well for transportation and spent fuel storage 5 analyses.

6 Thirdly, that where we re dealing with chemical 7 and physical processing of material we're dealing with 8 processes that are really in many ways similar to what goes 9 .on in the chemical inenstry and it made sense to pick up 10 techniques that were being developed in that area and that 11 is essentially what we did and what we are working with.

12 The area that was problematic is the one that

]

13 involves this wide variety of things that involved sealed 14 sources, loose material, just a whole variety of things, and 1

() 15 .there we had a contractor study that has~been working and 16 developing something that we have come to call 17 hazard / barrier analysis and we think that that might provide 18 a pretty good tool for doing risk assessment in this 19 industrial and medical area.

20 DR. APOSTOLAKIS: Can we get a copy of that? i 21 don't have a copy of that.

l 22 MR. COPLAN: You don't have a copy of it? Okay --

23 DR. APOSTOLAKIS: And also are there any reports 24 or papers where we can go and learn more about ISA? I 25 MR. COPLAN: Yes. We will get that for you too.

j

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42 1 DR. GARRICK: I assume we are going to come back

() 2 3

to this because this is --

DR. APOSTOLAKIS: Not today, I don't think.

,s

4 DR. KRESS: That request is not just for George. j 5 It's for the --

6 MR. COPLAN: Understood.

7 DR. GARRICK: Seth, just to pick up on something 8 that Carl said, from a curie standpoint, aren't the first 9 three the real issue as-far as risk is concerned and curies l I

10 are, is that so? 1 11 MR. COPLAN: I think generally yes. The only 12 reason that I hesitated at all on that is that some of the \

13 sealed sources have a fair amount of activity in them and 14 they get lost from time to time and there have been in some (n,) 15 parts of the world some pretty nasty accidents that involved 16 material from sealed sources getting dispersed, but l

17 generally speaking it is the first three that have the real 4 18 concentrations of curies.

19 DR. PAPERIELLO: I would beg to disagree and I 20- think if you ask Commissioner Dicus, because I know she made i

21 the remark, she believes the last group is the more -- or 22 has the greater risk.

- You are talking to distinguish 23 between probability and consequence.

24 DR. GARRICK: I was talking about curies.

25 DR. PAPERIELLO: Oh -- I'll admit. No , the source 1

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e 43 1 terms in the top ones are much higher --

2 DR. GARRICK: Right.

(

3 DR. PAPERIELLO: But if one actually takes a look 4 at people being really injured or killed, it comes from 5 radiographic sources, it comes from -- and people have been 6 injured in misuse of medical sources, so, you know, 7 depending on how you define the numbers, if you turn around 8 and take a look at person-rem, I suspect your last group 9 dominates, except perhaps maybe occupational workers is 10 dominated by the last group because there is no barriers 11 physically much between the public and the source.

12 DR. GARRICK: I think that one of the reasons for 13 mentioning it is that to the extent that we can have pointed 14 out to the committee the differences, the fundamental

() 15- differences between the materials and the reactors, it is 16 helpful.

17 Another area that strikes me where the differences 18 are rather profound is that when I think of materials I 19 think of the real risk of being operational. When I think

'20 of reactors, I think of the risk of being upset conditions-21 because the operational is much tighter controlled and 22 much -- in many respects more manageable than the materials

23. risk, so there is an interesting difference right there is 24 that we are very focused in the high level waste on the 1 25 long-term disposal, but on the other hand, there's a

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1 44 1 considerable amount of evidence that says the real risk in

)

2 materials is not in disposal but rather in operational, and 3 it is one of the reasons why there has been some challenges 4 by the ACNW as to why there isn't more attention given to 5 the operational phase of, say, Yucca Mountain -- but that is j 6 another difference that is very, very distinctive with 7 respect to materials over reactors.

8 MR. COPLAN: Yes. It is fundamental. I think one l

9 of the slides that Carl used focused on a number of the 10 differences and the degree of hazard is one of them -- just i

11 .the curies associated -- and another important one is how {

l 12 material can get dispersed. With the reactor you have an 13 energy source built in to do the dispersal, and in most 14 instances with materials you have to depend on some outside

() 15 16 agent of some kind doing whatever dispersal you are going to get if it is going to affect the public.

17 DR. GARRICK: Yes.

18 MR. COPLAN: And I am sure there are exceptions to 19 that. There always are when one makes generalizations about 20 materials activities.

21 DR. GARRICK: Of course.

'22 MR. COPLAN: The PRA policy statement provides l l

23 general guidance on what regulatory use should be made of I 1

24 risk assessment. Basically it says that it should be 25 applied to reduce regulatory burden where possible and to l j

i l

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Washington, D.C. 20036 (202) 842-0034 i

i 45 1 find gaps where there may be such gaps in regulation and Y 2 there are two principal considerations that I think one goes d

~3 through in trying to decide how are ycu actually going to 4 use risk in regulating.

1 5 Basically they are what is the Staff going to do, j 6 what will it do with risk insights and risk assessment in 7 developing regulations and guidance, licensing, inspection, 8 assessment and. enforcement.

9 An example might help. In Part 63 we decided that 10 we would put a risk criterion front and center as the basis 11 for licensing a high level waste repository and so you have 12- a performance objective that anticipates that the Department l

13. of Energy is going to do a performance assessment, that the 14 Staff is in some fashion going to review that performance

() 15 assessment, and it is all embedded in the regulation.

16 On the other hand, the approach could be something 17 that might be more applicable in some of the other materials 18 areas where we wouldn't expect a licensee to have the 1 19 capability of doing risk assessments and instead the Staff

'20 would do some assessments for the purpose of developing 21- guidance and developing what may be fairly prescriptive 22 criteria that the licensee would be expected to follow but 23 that would be more risk-informed than just some of the 24 judgmental bases that are in place now.

25 So in any event, the point is that those are

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g-46 1 choices that.have to be made when one starts thinking about 2 risk-informing regulations.

(}

3- The complement'of that is what do you expect the 4 licensee to be doing? Do you expect them to be actually 5 doing calculations as part of their operation or do you-

6. expect that they are going to implement criteria that are 7' risk-informed because of what the Staff did?

8 There are a number of factors that are important 9 in making those decisions. They include the hazard and 10 complexity of the activity,.the degree of human involvement 11 'in the activity, the technical sophistication of the 12 licensee community, NRC staffing and training issues, 13 Agreement State issues and others.

14 The consideration of these factors in the --

() 15 across'the full spectrum of activities that we regulate is 16 something that is going to have to have a lot of stakeholder 17 involvement so that we are really sure that we are 18 understanding the right issues and addressing them and we  !

19 would expect that we are going to end up with a pretty broad 20 spectrum of regulatory approaches coming into the i 21 regulations at the end. l 22 DR. GARRICK: Seth, aren't you already 23 contradicting your approach? It seemed to me I heard you 24- say at the outset that the task group in trying to formulate 25 recommendations and'what have you was forced in the interest

("')

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47 1 of getting the job done and simplicity to -- what I read --

() 2

.3 minimize stakeholder participation?

MR. COPLAN: No.

No , let me clarify. It is the 4 difference between development of the framework and 5 implementation. In a sense what we did is we moved what I 6 think is really essential stakeholder involvement from a 7 development phase of the framework to an implementation Y

8 phase, and there I think it is unavoidable.

9 DR. GARRICK: But isn't that one of the concerns 10- and arguments that a lot of the stakeholders have is that 11 they are brought into the process later rather than early?

12 MR. COPLAN: Again I have to agree. I don't think 13 that we are really running afoul with that because the 14 framework itself I don't think is where the stakeholders

(

(3 ,f 15 would find that if there is an ox that's going to be gored 16 that that is where it would happen.

17 In fact, we did attempt to have an Agreement State 18 representative on the task group and when we discussed the 19 project with the organization of Agreement States they in }

20 effect said we are covered' indirectly through another 21 project that we are involved with and when you get to the 22 implementation, come back -- then we will have a pretty 23 strong interest.

24 1he paper has a tabulation of what are really very 25 preliminary thoughts that the Staff has had about where all i

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48 1 'of this might lead in regulatory terms. By the time we get 2 through working with stakeholders and so on, I would be b)

3 surprised if it ended up that way. It will probably look 4 quite different but it is kind of a starting point.

5 Risk management, I guess the way that I think 6 about a lot of this is that risk assessment gives you tools 7 for being able to ascertain uhat the risk may be that's

-8 associated with some activity. It doesn't tell you anything ,

9 about hc= you should react to that risk as a regulatory 10 agency. And that side of things is risk management. It 11 involves deciding what risks are you going to look at, what 12 metrics are you going to use, what individuals or 13 populations are you interested in. Are you concerned about 14 property or aren't you concerned about property, and so on.

15 And then once you've looked at what risks you want to s

16 measure, then comes the issue of what targets or goals do 17 you want to establish.

18 In the nuclear area I think that it makes sense to

) 19 look at things in terms of -- I guess I have sort of a 20 mental matrix that involves workers and public and normal 21 operations and accidents, normal exposures and accidents, so 22 that you really, when you start thinking about managing 23 risks, you have to start thinking about managing worker risk 24 during normal operations, worker risk during accidents, 25 public risk during normal operations, and public risk during

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49 1 accidents. And for both the reactor and the materials' area, O 2 there are-metrics and goals that apply to normal operations.

U 3 They stem from international groups like ICRP, there is 4 Federal radiation protection guidance, and so on. And for 5 the Commission's purpose, this is all embodied in Part 20.

6 For upset and accident conditions at power 7 reactors, there are the qualitative safety goals and the 1 8 quantitative health objectives, and, as Carl peinted out, j 9 they don't really quite' fit the materials area, for a number 10 of reasons, unfortunately. It would be nice to really be 11 able to pick them up. And we're figuring though that we are 12 going to have to, you know, somehow come to grips with 13 targets, and in a way that takes into account the very 14 substantial differences between all the different kinds of 15 activities that we regulate. And it's something that I 16 think we're going to have to work very carefully and 17 completely with stakeholders on.

18 Some of the things that are pertinent to 19 developing accident goals for materials. First of all, with I 20 reactors, as Carl pointed out, deciding on what the target i

21 groups were is fairly straightforward. The reactors stay in )

22 one place, and you have a population around the reactors, )

23 and depending on what happens at the reactor, the population 24 may or may not be affected to some degree.

25 For materials it gets more complicated. You have ANN RILEY & ASSOCIATES, LTD.

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50 1 some fixed facilities, a number of them, some of which do

/~'T 2 have enough energy involved in the processes that go on in O

3 the facility to disperse material, some not. You've got a 4 lot of things, though, that take a fair number of curies and 5 move them around from one place to another. Radiography is 6 an example of that, a radiography source has a lot of curies 7 in it, and it goes from one place to another, and then we 8 have the problem of gauges that get lost and end up in 9 places that they, you know, you don't expect that they 10 should be, but the point is they're moving around through a 11 population. And deciding how, you know, how to -- who the 12 target is is a problem that we're going to have to confront 13 that is a little bit different than the reactor situation.

14 The kind of -- the way the risk works is

,m 15 different, too.

(v) With reactors, you're kind of in a situation where the real concern is low-probability, 16 17 high-consequence events. Our situation is that most of the l

l 18 risk involves relatively low-consequence events relative to 4

19 the reactor situation but with much higher probability.

20 They happen.

21 We, you know, we have a materials event data base, 22 as Carl pointed out, that involves fatalities and that sort 23 of thing. And so the fact that we actually see kind of a l 24 continuous stream of events because of the large number of 25 licensees that we have and the fact that you have these l

l l

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51 1 relatively high-probability, relatively low-consequence

(} 2 things' going on, you see things happening, which is unlike 3 the reactor situation and is again something that I think 4 would have to be addressed in developing a safety goal.

5 And then in addition to those factors there are 6 some purely institutional considerations, namely that there 7 are an awful lot of people who have an interest in 8 standard-setting where materials are concerned. EPA is 9 heavily involved, ICRP, NCRP, and they have different levels 10 of authority, but all are involved, and all of them have to 11 be dealt with in however we would proceed in that area.

12 And then, at the risk of belaboring a point, 13 there's just this tremendous difference in the capability of 14 licensees to address risk in their activities, in the -- and

() 15 the value that society gets from what they do. And somehow 16 that has to be accounted for.

17 DR. GARRICK: But that fact cannot remove the 18 accountability.

19 MR. COPLAN: That's right. That's right. But, 20 you know, I think it's something that you have to address at 21 least at a philosophical level. In a sense the reactor 22 safety goal recognizes that you don't want to have I guess 23 it's a societal risk associated with the generation of 24' nuclear power that's in excess of the risks associated with 25 generating electricity by other viable means, so that

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52 1 there's a recognition that the risk doesn't come in a 1

() 2 3

vacuum, it's because you're trying to get something, and it's part of what you pay for what you're getting.

4 The framework that we came up with is fairly 5 similar to the reactor framework. It has four. parts, 6 basically.

7 The first part is simply identifying all of the 8 areas in NMSS where risk-informed regulation is a 9 possibility. A little bit different than the first part of 10 the reactor framework, in that the reactor framework deals 11 with only one activity, reactors. We've got to deal with 12 fuel-cycle facilities, with geologic repositories, and so 13 on, and each one of these has the same collection of 14 activities that -- or regulatory areas that you might have I

) 15 with a power reactor. And so the idea is to be able to look 16 at these and say is this something where risk-informed 17 regulation can bring a benefit or not?

18 There are so many of them that we have no hope of 19 kind of working through in a kind of a perfectly logical 20 fashion from start to finish we're going to be somewhat I 21 resource-limited in what we do, and so we're going to work 22 through these in a prioritized sort of way, and one of the 23 things that we'll have to do early on is establish how we're 24 going to do the prioritizing, one thing has to be external 25 drivers. For example, we've been driven to a riek-informed ANN RILEY & ASSOCIATES, LTD.

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53 1 approach in-high-level waste regulation by certain external 2 factors and by some factors that are just kind of intrinsic d('T 3 to the-repository problem.

4' The second part is having identified areas where 5 the staff thinks that-there's promise, that we would work 6 with stakeholders to identify metrics and to -- I'm sorry, I  !

7 jumped ahead here a bit.

8 The second part of the framework, I started to 9 think about the implementation. The second part of the 10' framework is to make sure that we understand what underlies 1

11 the current approach. What are the deterministic 12 considerations that are there, what sort of. institutional 13 concerns, and so on, make it what it is now.

14 Thirdly, what are the elements that risk

() 15 . considerations could improve, and what could come out of 16 that.

17 And finally, how can the things that are there now 18 that we like be integrated with the risk aspects?

19 And to implement, we came up with a five-step 20 process, the first of which I described in talking about the 21 first part of the framework.

22 The second step is one of deciding how to modify i 23 the current regulations, with this understanding of what it {

24 is you want to keep about it, what is it that you can gain 25 from risk. We would start thinking about metrics and goals

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54 1 and the issue of what is it that the Staff would do, what is

'2 it that the' Licensee would do, and bring in stakeholders 3 pretty heavily at that stage.

4 The third step would be to make the appropriate 5 changes to the regs and guidance.

6 The fourth step would be to make sure that the 7 Staff is knowledgeable in the new approaches to do whatever L 8 training is needed to accomplish that.

9 And then the fifth step is developing and adapting 10 the tools needed to make these things go.

11 The -- I think that I have really covered most of 12 the points on this slide. Basically let me just say that we 13 see this as just an extremely important part of making this 14 work. It would --

() 15 DR. APOSTOLAKIS: You know, the issue of 16 stakeholder involvement in risk management is something that 17 is of great interest these days, and the National Academy of 18 Sciences and Engineering have published -- issued reports l 19 through the National Research Council, the other NRC, where 20 they outlined approaches to using or to bringing 21 stakeholders into the process and so on. I wonder whether 22 something, especially in the analytic deliberative process ,

23 that is now something that people are trying to recommend, I 24 wonder whether these things would work here. One of the  ;

l 25 principles is that'you'should bring the stakeholders into l

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o 55 1 the process very early, and have them involved also in the 2 risk assessment process. You are not really assessing any

(}

3 risks here, you are planning to revise the regulatory 4 system?

5 MR. COPLAN: That's right.

6 DR. APOSTOLAKIS: But, even so, it seems to me 7 that bringing them in early in the process would help, and I 8- assume you are familiar more or less with that literature.

9 MR. COPLAN: Yes.

10 DR. APOSTOLAKIS: By the way, is this committee a 11 stakeholder?

)

12 MR. COPLAN: Yes.

13 DR. APOSTOLAKIS: So you would involve us --

14 MR. COPLAN: After a fashion.

() 15 DR. APOSTOLAKIS: -- you would involve us early in 16 the process?

17 MR. COPLAN: .You couldn't get much earlier than 18 this.

19 DR. APOSTOLAKIS: In the future I would really 20 appreciate it not being presented with a SECY when it's 21 final. When you plan to do something, it would be a good 22 idea to come before us and get some ideas, because this is a 23 new area, I think, for most of us, and reviewing a finished 24 product can only lead to trouble. And, you know, the 25 committee will make sure that it reacts to your proposals O ANN RILEY & ASSOCIATES, LTD.

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56 1 appropriately, that they are not final and, you know, trying

( 2 to develop something, if my colleagues agree, because

}

3 reviewing the final product sometimes is a risky 4 proposition. This is the fifth area of risk, you know, in 5 your --

6 MR. COPLAN: I am hoping that this will be unique.

7 DR. APOSTOLAKIS: Okay.

8 MR. COPLAN: In this. I think that the model that 9 we have in mind for the interaction with the subcommittee is 10 one that would be similar to the interaction that the Staff 11 had with the ACRS over the development of the risk-informed 12 guidance.

13 DR. APOSTOLAKIS: You are very well informed.

14 MR. COPLAN: That's what we're -- that's our goal fg

( ,) 15 here.

16 DR. APOSTOLAKIS: So we are in agreement.

17 MR. COPLAN: There is not a lot to say about the i 18 next chart here, just that we had committed in SECY 98-138 19 to look at the PRA implementation plan, and to look at the 20 activities we have listed in it, decide whether we thought 21 they remained appropriate. Given the framework, we did 22 that, we think they are. The other point is that we are 23 planning to come up with a -- well, as we lay out plans for 24 implementing the framework, they will be int .rporated into 25 the PRA implementation plan, and that will become the way of

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57 1- tracking our implementation.

\ 2 Just in conclusion, we have used risk assessment

(_)

3 in'the materials area for a long time, but the degree of 4 development of applicable methods and experience in using 5 them has varied from one area to another, and I think 6 consistent with really the importance of bringing risk

-7 assessment into play.in those areas, we have proposed a 8 framework to the Commission for expanding the uselof 9 . risk-informed approaches in the materials area. We would 10 see implementation as involving a pretty significant effort.

11 We think that. stakeholder involvement is extremely i 12 important, and we will value input'from the subcommittee for 13 technical peer review.

14 DR. GARRICK.: Thank you. We've already passed our (f 15 break time, but I think that while Seth is up front that 16 maybe we should take a little more time and ask the 17 questions now, and then take a break. So going in a little-18 different order, George?

19 DR. HORNBERGER: Seth, one of the concerns, of 1

20 course, about risk-informed performance-based regulation is 21 that licensees could see it as regulation on top of existing 22 regulations and, of course, that's a concern that we all are 23 sensitive to and want to avoid. It's pretty clear in some 24 of the areas that you mentioned -- for example, high level 25 waste disposal performance assessment as well, it's well )

I

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58 l

1 known to be the' method of choice. If we look at something

() 2 3

like sealed sources, do you have confidence that the framework that you have outlined is not going to add a 4 burden in any way to the licensees?

5 MR. COPLAN: If we do our job right, it shouldn't.

6 And I guess the reason that I would say that is that 7 starting from the general guidance in the PRA policy 8 statement, what we'd be looking to do is to reduce 9 regulatory burden where possible by using risk methods, and 10 where using them reveals, you know, some sort of a gap in 11 the regulations, we might make a change there. So, I mean, 12 to begin with, the basic idea is one of using it to reduce 13 regulatory burden.

14 Secondly, we recognize that the -- that that

() 15 licensee community is one that doesn't --

it doesn't make 16 sense to burden them with doing risk assessments; that for 17' them, the kind of regulatory framework that exists now, 18 that's fairly prescriptive, that has fairly prescriptive 19 guidance, is probably the right one, but it may need to be 20 reexamined from the standpoint of are we focused on the 21 right areas.

22 DR. GARRICK: George?

23 DR. APOSTOLAKIS: Well, where do we go from here?

24 I mean what --

25 DR. GARRICK: Well, if you have any questions --

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7 59

-1 DR. APOSTOLAKIS: No, I don't have any questions.

~T 2 The Staff is.not asking for a letter or anything at this

. [O 3 time. Are you?

4 MR. COPLAN: No.

5 DR. GARRICK: Tom?

6 DR. KRESS: No.

7 DR. GARRICK: One of the things that as a 8 practitioner in the risk field, and therefore.a little bit 9 short-sighted on some of these global issues, that strikes 10 me is that when you talk about the implementation of the 11 framework, I am a great believer in it, in the top-down 12 thought process, and you say that the first step is to 13 identify the specific regulatory applications that are 14 amenable to expanded use of risk, et cetera, et cetera. As

() 15 'a practitioner, of. course, I think the first step ought to 16 be based on our vast knowledge and experience, what does 17 NMSS think the real risk issues are in materials, one 18 through 10? And, of course, this has a process 19 implementation, and I'm asking the question, well, you've 20 got a lot of experience, and you have been, as you've said, 21 doing risk work for a long time and safety work for a long 22 time. I like the categorization into the four, I'd make it

'23 five, and I'll tell you why in a minute.

24 But one thing that would really, I think, help l 25 ~ this committee would be for us to have the full benefit of

!=

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w l 60 1 your knowledge of what the risk issues are. Where is the

() 2 3

problem here? We have identified some fundamental differences, the upset versus the operational, and the 4 populations that are affected, and the variety of other 5 things. But I would guess that there are some opportunities 6 here to narrow this problem down, whether it's done on a 7 curie basis and, as Carl has pointed out, that's different 8 from a risk basis, isn't so much important as us knowing 9 what those things are. Because as I look at your 10 categories, I look at them -- I looked at one category that 11 would be basically the disposal activity. That's where you 12 get rid of it for all time. And the other category that I'd 13 put as maybe the next one would be the process and 14 manufacturing facilities, because that's a category where we .

'\ l 15 can take maximum advantage of the reactor experience and 1 i

16 what-have-you.

17 And then the third category that I would think of, 18 and it lines up with yours except you have joined it with 19 transportation, I would have storage and then I would have 20 transportation as a separate because transportation is a 21 bogeyman in the risk field.

22 There is this tendency to think that you can't 23 move hazardous materials. I am reminded of the chemical 24 weapons program where a very preliminary transportation risk 25 analysis resulted in about a $15 billion decision to build ANN RILEY & ASSOCIATES, LTD.

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n-61 l' processing plants at each of the otorage sites rather than s

.f'T 2 either a central processing plant or a regional site because

%)

i .3 of the. transportation _ risk.

4 I think transportation is another area that is

~5 .very amenable to_the kinds of analyses and methodE that have 6 been developed.and tuned and that you have used,-and so I 7 'would consider it separate.

8 The~other thing I wanted to comment on the 9 categorization is that -- and I will be struck by lightning 10 on this one -- because I have always said that the biggest 11 lesson that we have learned in reactor risk is that risk is 12 plant-specific and therefore you have never known of a 13 generic plant to fail or have an accident, but on the other-

l. 14 hand when you talk about something like sealed sources,

! ' ('N 15 radioactive sources, this strikes me as something that l( j 16 really lends itself to a very good generic analysis of 17 asking the questions of'what can go wrong with the sources 18 and what are the consequences and what have you, so that 19 strikes me as very much an exception to the approaches of 20 getting consumed in the fine structure of individual seals 21 and individual sources. Now there may be categories of 22 sources you would want to ferret out.

23 But back to the question of the five step process.

24 Is there a way that you could get in front of this committee i

L 25 your collective and expert judgment as to what you consider l

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62 1 to be the top 10 risk issues associated with materials O 2 handling?

b 3 MR. COPLAN: Oh, I suspect we could, yes.

4 DR. GARRICK: Wouldn't.that be helpful, really 5 helpful to us, to know from the real experts what the 6 judgment is right now from a risk perspective?

7 MR. COPLAN: Yes, I suspect to could do that.

8 DR. KRBSS: Wasn't there a Scientech report on the 9 risks associated with it?-

10 DR. GARRICK: There was something, yes.

11 DR. KRESS: That would help, to get that. I have 12 read it in here somewhere but I couldn't find it in here.

13 It exists. It is in the packages.

14 MR. COPLAN: If I am not mistaken, which I could

( ) 15 easily be,.but that sounds like it may be the report that 16 deals with this barrier / hazard analysis or -- I 17 DR. APOSTOLAKIS: Yes.

18 MR. COPLAN: Or with diamond trees and all that 19 stuff.

20 DR. APOSTOLAKIS: It is the same one?

21 DR. KRESS: No. No, I don't think that was the 22 one they had in mind.

23 MR. COPLAN: Okay.

24 DR. APOSTOLAKIS: Well, maybe it is not Scientech.

25 They just say a contractor.

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g 63 1 Who was your contractor? Why is he a secret? In

(} 2 98-138 you refer to a contractor who developed the report?

3 MR. COPLAN: It was Scientech.

4 DR. APOSTOLAKIS: Scientech. It is not the same 3 2

5 report though?

l 6 MR. COPLAN: I think it is, yes.

1 I am getting )

l l 7 nods from the back of the room that it is. l 8 DR. APOSTOLAKIS: But that was for reactors.

9 DR. KRESS: Yes.

10 MR. COPLAN: Oh, oh, oh, oh -- there were two that 11 were done. There was one done for reactors and one done for l 12 us, very similar in terms of the methodology.

13 DR. APOSTOLAKIS: So it was a diamond tree again?

14 MR. COPLAN: Yes, yes.

() 15 DR. APOSTOLAKIS: Wasn't there an ACRS letter on 16 that? Have you read that letter?

17 MR. COPLAN: I have not.

18 DR. APOSTOLAKIS: Yes. It is a recent letter.

19 MR. COPLAN: Okay. We will have to get it.

20 DR. GARRICK: Any other comments, questions for 21 Seth from either the subcommittee, the other committee 22 members or the Staff?

23 [No response.]

24 DR. GARRICK: Okay. Well, thank you very much.

25 MR. COPLAN: Thank you.

l i

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7 l

64 l L 1- DR. GARRICK: And I think with the permission and

[~h~ 2' the concurrence of the co-chairman, we will take a break for lV l 3- 15 minutes. Thank you.

4 [ Recess.]

5 DR. GARRICK: I think there are a couple of things 6- we want to cover in the remaining time, which is about an 7 hour and fifteen minutes.

8 Number one is based on what we have heard today, 9 what does the subcommittee think is the direction we ought 10 to be taking? We through the questions that we asked 11 implied some directions. It sounds.like that on the surface 12 at'least there is additional information that the 13 subcommittee wants to see, that maybe a letter is an 14 appropriate. We'll get some more guidance on that issue 15 (A) from the Staff I am told, but for the time being at least it 16 seems that there's these other documents that we would like  ;

1 17 to see and maybe even hear about, although I think it would I

18 be appropriate based on what we have heard for us to discuss 19 the issues some.

20 The second thing we want to see if we can resolve 21 is, as you know, the subcommittee process is a work in 22 progress in terms of how it is going to work and the 23 supporting documentation for it, and we need to talk about 24 that a little bit and see if we can come to grips with any 25 remaining issues for how the subcommittee will function.

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l' 65 1 So I think with that.I would like to hear from the

() 2 3

subcommittee or the members, their views on how they think on the basis of what we heard we should proceed. I am open 4 to suggestions as to who would like to comment first --

5 .maybe Tom, you would like to comment on that.

6 DR. KRESS: Yes, I will. First off, I think the 7 issue is one of risk. We're controlling risk and I.think we 8 need to recognize the different methods that have.been 9 suggested like PA and'ISA, PRA are all risk assessments by 10 different names and that we are interested f.n what I guess 11 you would call the risk triad or the triplet.

12 DR. GARRICK: Triplet.

13 DR. KRESS: Triplet, okay, and that somehow in all 14 the activities we have to address that triplet and g.

) 15 regardless of how the process is whether it is formal one, 16 whether it is qualitative or quantitative and whether it 17 adds up all the sequences or just the major ones or not, 18 we -- I think somehow we need to get that principle in 19 there.

20 The other one is I think we do need to develop 21 some high level principles as a committee to guide our view 22 of how to review this stuff and some of those high level 23 principles have to deal with acceptance criteria and risk 24 acceptance criteria as well as the uncertainties associated 25 with those.

1 j

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66 i

1 My own feeling is that we have to have a common l l

(' 2 3

metric on risk acceptance criteria and I don't know what it is right now, but I suspect somehow it has to do with the

{

4 risk benefit is a common metric that ties them all together, 5 and the uncertainties have to be dealt with some way by 6 defense-in-depth,.so I think we have a problem on how to 1

7 wrestle with the defense-in-depth in this arena because it  !

8 may mean something besides barriers when we talk about the 9 wide range of things that we are dealing with.

10 I think among ourselves we have to figure out what 11 our principles are on addressing this and those are some of 12 them that I think we have to deal with.

13 George, did you have anything to add to that?

14 DR. APOSTOLAKIS: Well, who is going to do this,

( 15 Tom?

16 DR. KRESS: That's the --

l 17 DR. APOSTOLAKIS: Not the committee?

18 DR. KRESS: Well, I think the committee ought l 19 to -- you know, I don't think we can sit by and wait for 20 somebody to come and bring a set of principles to us. We 21 need to think about high level principles. We don't have to l 22 quantify them but what are the principles associated with 23 this?

24 DR. APOSTOLAKIS: Or we can write a letter 25 recommending that the Staff do this, because I think it is l

l

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[ 67 1 going to take some considerable effort to think about this 2 and come up with proposals,'and we can certainly work with 3 the Staff but to go through another exercise where we have 4 to do it, I mean we are just finishing the defense-in-depth 5 letter and you know how much trouble that was.

6 DR. GARRICK: Just to help me-understand, Tom and 7 George, when you talk about principles are you talking about 8 something along the lines of what was generated through the 9 ACRS interaction with the NRR Staff on the set of 10 principles?

11 DR. APOSTOLAKIS: 1.174, yes.

12 DR. GARRICK: Yes, guiding the implementation 13 of -

14 DR. APOSTOLAKIS: Yes -- high level principles, 15 which is related really to_your top-down comment earlier.

16 DR. GARRICK: Right.

17' DR. APOSTOLAKIS: I mean at the very t<,p what is 18 it that we want to do and that will give us also an 19 opportunity to say a few words about language and establish, 20 you know, the common framework.

21 DR. KRESS: And I think we should have some sort j

22 of a graded approach to regulations in this area d 23 particularly. I think there are some beyond regulatory 24 concern issues here.

)

25 DR. GARRICK: Yes.

t I

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68 1 DR. KRESS: And, you know, it appalls me that we 2 are regulating at the very low millirem level in this area.

[}

i 3 I think we need-to think about where are or what are the 4 -real issues in terms of health effects and risk associated 5 with that but that is treading on' land that --

l 6 DR. HORNBERGER: Quicksand.

l l 7 [ Laughter . ]

8 DR.'KRESS: Yes, quicksand. That is the word I 9 was trying to get in.

10 DR. GARRICK: George, do you -- based on what we 11 heard, what is your thought on where we should go?

12 DR. HORNBERGER: Well, I mean I think that the 13 only other thing in addition to what has already been talked 14 about, and perhaps that is part of what we have talked lA) 15 about, is these-issues of how the licensee uses risks and 16 exactly how the NRC uses -- makes the connection between the 17 risk assessment and a regulation. Perhaps that is really 18 just in the risk acceptance criteria. Maybe that is just 19 'another way of saying that.

20 DR. KRESS: Yes. I meant to mention that also. I 21 think it's probably not practical to ask every licensee to 22 make his own risk assessment in this area.

23 DR. HORNBERGER: Right.

24 DR. GARRICK: Right.

25 DR. KRESS: Somehow the NRC has to do a lot of I

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p 69 1- 'that and reflect that in the acceptance criteria that they 2' come up with, which very well may be very prescriptive.

(( )

L 3 DR. GARRICK: Yes. The' materials field doesn't 4 have'the great focuser that the-reactor field has in terms 5' of everything centers around avoiding core damage. There is 6 not a counterpart here on the materials side that aids the 7 whole process of organizing the issue in the same way, and 8 solit seems as though they kind of'got a start on what may 9 be a direction that we will have'to go of maybe four or five 10 different categories of issues that have to be addressed.

11 And then there is one, the only one that sits i

12 apart from all the others perhaps is the Yucca Mountain 13 issue. That is clearly a singularity in the whole arena of i 14 materials risk. But the rest of it needs some real

()

15 organization to be able to provide focus to what the risk 16 are and' understanding the problem. I think that that kind i 17 of information has to be before the staff before anybody can 18 be thinking about the concept of safety goals and 19 what-have-you.

1 20 I think one of the things that this committee 21 probably feels a little different about than maybe what we 22 heard is that -- what the world of risk assessment is all 23 about. I think of us see the four categories of activities 1

24 that they have as really being a variation of scope of the  ;

25 application of risk assessment more than different methods j i

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f 70 1 being applied. You still ask the same questions. You only j' } 2 deal with the answers to the extent that is necessary within 3 that category and no more. So I think there is an 4 opportunity there maybe for some advice down the road. But 5 I do believe that we need to have the benefit of more of l 6 their understanding of what the risk issues are before we 1

7 are in a position to do that.

8 DR. APOSTOLAKIS: If we'did nothing, I mean we 9 wrote a letter this time and so on, what are the staff's l

10 plans? What do you plan to do and when will be the next 11 time you will come before us, and with what? It is not 12 clear to me what --

I mean do you have an SRM now that you 13 have to respond to and at some point you want to come before 14 this committee?

/~

(%) 15 MR. COPLAN: We don't have an SRM yet.

16 DR. APOSTOLAKIS: But you know there is one 17 coming?

18 MR. COPLAN: Eventually we will get an SRM. We 19 don't know what it is going to say.

20 DR. APOSTOLAKIS: So if we write a letter now, we 21 may influence the SRM.

22 MR. COPLAN: That is true. That's true.

23 DR. APOSTOLAKIS: Okay. So what are we going to 24 do? I mean when are we meeting again, and what will you 25 present?

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l.

( 71 1 MR. COPLAN: I think we were figuring that we-

[ -2 wanted to see an SRM before we got real deep into, you know, 3 into planning exactly where we were going to go next. I 4 mean that is part of the reason that we didn't get to this 5- subcommittee until the paper was written actually.

6 I think that one of the first things that we would 7 anticipate doing is identifying what we would put into the 8 PRA implementation plan. And it just seems to me that the 9 thinking that goes into that might be something to discuss 10 with the subcommittee.

11 DR. APOSTOLAKIS: So, well, it seems to me then 12 that if we want to influence things, we ought to write a 13 letter stating what we think --

14 DR. HORNBERGER: Should be done.

r i 15 DR. APOSTOLAKIS: Should be done. And 16 recommending to the Commission a certain course of action 17 and leave it up to them-whether they want to issue SRMs or 18 not. Because the process is til-in the very early stages 19 and we don't know which way we are going to go, right. So 20 maybe a letter is appropriate.

21 DR. GARRICK: Yes, I was thrown off a little bit 22 on the letter issue by the question that was raised earlier 23 by Tom when you were making your presentation. But it seems 24 that if we do want to impact, and there is value added in 25 our impacting the SRM, that a letter with some preliminary ANN RILEY & ASSOCIATES, LTD.

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i 72 thoughts and ideas on how to proceed might be beneficial.

~

1

[)

'%)

2 Now, if we were to write such a letter, Tom, is it 3 your thought that we should attempt a stab at some basic 4 principles?

5 DR. KRESS: Yes, that would be my thought, but 6 George seems to think that is more of a task than we are up 7 to at the moment.

8 DR. APOSTOLAKIS: Well, Tom, if you can produce 9 something, I would be happy to read it. But I know how hard 10 it is for part-time advisors to put together something that

11. is archival.

12 DR. KRESS: That's tue.

13 DR. APOSTOLAKIS: And, you know, the 14 defense-in-depth letter, we are writing a letter on (O) 15 defense-in-depth on the ACRS and Tom had the lead on that.

16 DR. KRESS: It is very painful.  ;

i 17 DR. APOSTOLAKIS: It is extremely painful. So my l 18 inclination would be state our concerns and what we think i 19 ought to be done at a high level, and then recommend -- and 20 maybe give some preliminary thoughts, I mean we can do that, 21 especially if we give alternatives where you really don't 22 have to vote then that you like this one versus the other 23 one, and then recommend to the Commission that they ask the 24 staff to actually spend some serious time on those. And 25 that will help everybody, I think, you know.

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73 1- Like, for example, one could be the principles.

j 2 Another one would be the

) Tie it to the top-down approach. ,

3 language, clear up the language and make it consistent with 4 .the white paper of the Commission. Another one, I Would 5 like to see some words about other aspects of risk like 6 controllability and so on, that influence the decisions. I 7 The necessity for goals. Maybe the Commission ought to 8 think seriously about .'.t, you know, that they should ask the 9 staff to think about establishing goals before they do 10 anything else.

11 DR. HORNBERGER: Goals?

12 DR. APOSTOLAKIS: Goals, safety goal.

13 DR. GARRICK: Well, actually, it seems to me that 14 one of the things we could do that would be rather specific, r

8 15 because it embraces the prior work to some extent, is for 16 the committee to comment on SECY-99-100. That has in it i 17 most of the issues that we have been talking about, 18 including the categorization, including the activities that 19 are involved. So maybe a first cut comment on SECY-99-100 20 would be a constructive initial product.

21 DR. HORNBERGER: But that would be basically the 22 platform to promote the ideas.

23 DR. GARRICK: Yes. Right. Including the idea of 24 the need for some basic principles.

25- DR. HORNBERGER: Yes.  ;

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74 1 DR. GARRICK: Seth, would you think that that as a 2 strategy would be constructive? {

3 MR. COPLAN: .Yes, I think it would. I would just 4 mention one thing and that is that we haven't really set any 5 resources at all aside to do this effort for FY '99, we are 6 not really planning to get started until FY 2000 and then we 7 are figuring on a level of effort that would be about 8 FTEs 8 per year office-wide, including some things that are 9 ongoing, so there are going to be some other demands on 10 resources, too.

11 DR. LARKINS: Yes. To add to that, I think_ plan 12 for about three meetings of the subcommittee per year in the 13 request.

l 14 DR. GARRICK: Okay. All right. Well, I think if ,

!(/'Tj 15 the subcommittee is in agreement with this, then we will '

16 attempt to draft a letter on our view on what we heard and 17 particularly on 99-100.

18 DR. APOSTOLAKIS: Yes, and I would appreciate.

19 receiving those documents we requested as soon as possible, 20 because I would-like to have a chance to look at them before 21 we finish the letter.

22 DR. GARRICK: Yes. Yes, I think so. Okay.

23 MR ., COPLAN: Do you have any idea what the timing

-24 of this letter might be?

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l 75 1 topic.

2 DR. HORNBERGER: That's right.

3 DR. GARRICK: If we can resolve a procedure here 4 that doesn't get totally; bogged down in practicing what we

5. preach, namely, of trying to keep things simple, it 6 shouldn't be too long.

7 Yes, Charles.

8 DR. FAIRHURST: Can I just ask a question? I am a 9 little hesitant here, but being the fool, I will rush in 10 where all the experts apparently fear to tread. But it is 11 interesting to listen to what Carl and Seth were saying, that there appears to be an implicit assumption that you can i

12 l

.13 define the risk. And yet we just came from a workshop last 14 time where this linear no-threshold hypothesis is highly --

() 15 well, a lot of people think it is extremely uncertain.

16 And I am' wondering if you are going to build a 17 large superstructure of regulations and codes which are 18 built on possibly an unsure foundation unless they get too 19 rigorously built in, which it will take a lot of effort to 20 get them in.

1 21 And let's say five, eight years down the road, 22 somebody comes up with some biological research in the human 23 genome studies and says, look, you are all wrong. There is

! 24 a threshold that is 5 rems or whatever there is. Would it l

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i 76 l 1 that as a -- whatever. You would arouse an enormous amount

/~'% 2 of misgivings and upsets and so on.

i V I 3 So at the outset, one would need to predd cate all 4 of the results drawn from the study on a strong discussion 5 of the uncertainty of the foundation. I don't know how much 6 that -- because when you are talking & bout, for example, as 7~ Carl was, risk benefit, that would change dramatically-8 depending on the definition of the risk.

8 9 DR. GARRICK: Right. If we take the measure of )

10 risk as a dose, for example, we get around part of that 11 problem because we are not having to work through the i

12 dose --

13 DR. FAIRHURST: That is what I am saying, the 14 experts must know a way around of comparing A to B, rather (s) 15 than comparing absolutes, et cetera, et cetera.

J 16 DR. KRESS: Yes, I think that might be one of our 17 principles. Let's deal with dose.

18 DR. GARRICK: Yes. Right.

19 DR. KRESS: Get around those problems.

20 DR. GARRICK: Get around the dose response curve.

21 DR. KRESS: As long as your acceptance criteria 22 properly' reflect things of risk, why, I think dose is a 23 perfectly. good measure.

24 DR. GARRICK: Right, but --

25 DR. FAIRHURST: But in the waste isolation, that ANN RILEY & ASSOCIATES, LTD.

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77 1 is going to be critical.

() 2 3

DR. GAFRIC K : Yes. Well, Yucca Mountain is moving in the direction of a Soso standard.

4 DR. FAIRHURST: I know, the definition of what 5 dose constitutes a risk.

6 DR. GARRICK: Yes. But I don't think they are 7 going to answer that, even --

8 DR. FAIRHURST: No, I know they are not.

9 DR. GARRICK: Yes. Right. Any comments from the 10 staff?

11 DR. LARKINS: Yes. It seems to me one of the 12 things that might be beneficial, if you could help the staff 13 in terms of prioritization, in terms of approaches. Now, 14 there's a number of parameters to consider, risk, the impact

() 15 on stakeholder, the likelihood of success in doing something 16 along this line and various methods to do that. So I think 17 if you are going to early on provide some guidance, maybe 18 give some thought to how they might want to proritize, or 19 develop an approach for prioritizing which regulations and 20 things they take on.

21 DR. GARRICK: Well, you know, my problem with that 22 is I need to know what the problem is in order to do that.

23 DR. LARKINS: Yes. Well, I understand. And that 24 goes along with your request, I think, for those areas where 25 there seems to be the greatest risk significance in the

'~\

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78 1 regulations.

2 DR. GARRICK: Right.

)

3 DR. LARKINS: And that is certainly one parameter, 4 but there are probably another five or six that might be 5 considered.

6 DR. APOSTOLAKIS: Now, just a comment here on the 7 principles. The staff came before the ACRS about a month 1' 8 ago and they proposed to develop overarching principles of 9 regulation that -- and goals, right -- that would apply to E10 reactors and NMSS activities and so on, and the ACRS -- and 11 I assume NMSS participated in that proposal.

12 MR. COPLAN: Yes.

13 DR. APOSTOLAKIS: The ACRS was very cool to the 14 idea. They felt that we can do much more that would be (bf 15 useful in the reactor area in the next several months and 16 trying to bring everything under the same umbrella.

17 But, on the other hand, we did suggest that they 18 spend some time thinking about these overarching principles 19 and goals. So you may want -- I mean that certainly should 20 appear in our letter someplace so that the staff has already 21 thought about it. And I don't know how -- the staff has not 22 responded yet, have they? I have heard through the 23 grapevine that you are actually implementing the 24 recommendation, but I haven't seen it in writing. This is ,

i 25 just a comment, that the staff has already thought about O

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F~

f 79 1 some of what we are talking about.

L

() 2 3

DR. GARRICK: Yes. Right. In other words, there is the conflicts here, there is -- on the one hand, you 4 would like to be able to assure the public that there is l

5 consistency in the thought process behind the formulation of 6 regulations be they for materials or reactors.

7 But on the other hand you've got to get the job 8 done.

4 DR. APOSTOLAKIS: That's right.

10 DR. GARRICK: And if you can see a way to solve it 11 for one group of things and not yet see a way for another 12 one, you shouldn't wait.

13 DR. APOSTOLAKIS: Exactly. That was the idea, 14 really.

() 15 DR. GARRICK: Yes. Right. Right. Yes, okay.

16 DR. LARKINS: Along that line, there are 17 overarching issues which come out of some of the things that 18 have been done on the PRA, which have been done on Part 63, 19 that this group should probably think about. George and Tom 20 were mentioning the problem that we're having with defense 21 in depth on the Part 50 stuff. Certainly there's an issue 22 on Part 63 and some of the other regulations, and if you're 23 going to have consistency or coherency in the regulations, 24 you might want to consider that.

25 The other thing is John Garrick made a point of ANN RILEY & ASSOCIATES, LTD.

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80 1 not making tra mistake of some of the things that came out (3\_ ; 2 of implementation or use of PRA. I think also you want to 3 take a look at lessons learned from the use of ISA, hazards 4 analysis, and PA, and fold that into your thinking also.

5 So you might want to ask the staff the next time 6 they come in to tal:c about lessons learned from the use of 7 these various methodologies, since they are proposing to use 8 that as various tools or methods for different regulations.

9 And there's been a lot done by DOE and Defense Department 10 and others in some of these areas.

11 DR. GARRICK: Yes, Ray.

12 DR. WYMER: I'm in the same position that Charles 13 is in of really not knowing much about this field, but I'll 14 make a comment anyway. l r'~%  !

l

,) 15 The SRM of April 15, 1997, says to develop a l

16 framework for applying PRA to nuclear materials uses similar 17 to the reactor framework. There's a big difference between i

18 that and developing overarching principles that cover both i 19 the reactors and the nuclear materials. You get down in to 20 'substantially mcre detail addressing what the SRM says than 21 if you try to do these overarching principles which have to 22 be very general in nature. What are you really trying to do 23 here, and how closely are you tied to having to do what the 24 SRM says?

25 DR. GARRICK: Well, I think what we're trying to

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81 1 do is find something we can anchor ourselves to.

[ h 2 DR. WYMER: Something you can do.

V 3 DR. GARRICK: That we can evolve from, that does 4 deal with the question of consistency and the kind of things 5 that.were discussed in the strategic initiative document, 6 but we have to be very careful about that, that's right.

7 That's one of the reasons for the joint committees is to 8 begin to, since we're both offering advice on these very 9 broad issues like how to implement risk-informed, 10 performance-based regulatory practices, we need to begin to 11 think about the overarching, but not to the extent that it 12 keeps us from getting other things done where the path is a i 1

13 little clearer. But, yes, there are some tough problems 14 here, and we obviously don't have the answers.

() 15 DR. HORNBERGER: Andy has a comment.

16 DR. GARRICK: Andy?

17. DR. CAMPBELL: One of the issues that came out in 18 Carl's presentation and also Seth's presentation are the 19 incidents that occur with sealed sources, and what I don't 20 think the Committee has in front of it is, you know, some 21 sort of statistical analysis of what the frequency of those 22 incidents are and the consequences. Are they mostly burns?

23 Are there -- you know, there are fatalities that are 24 reported occasionally.

l 25 But that would be helpful, and I think also one of l

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82 1 the considerations in_ applying a risk-informed basis would 2 be can a risk-informed approach reduce that frequency and, 3 you know, what are the costa and benefits of that.

4 DR. GARRICK: Yes, I think the main --

5 DR. CAMPBELL: What is the connection to having a

6. risk-informed approach as applied to sealed sources in terms 7 of actual safety which is reducing the incidents that occur?

8 DR. GARRICK: Right. Right. The main value 9 received from a risk-informed approach in my opinion is to 10 help us gain perspective on issues that affect risk, and to 11 help us therefore be in a position to allocate resources 12 accordingly as to what is most important. And I think that 13 also we need to be very conscious of these marked 14 differences between the two problems.

() 15 DR. APOSTOLAKIS: But I have a question about 16 that. I mean, the whole idea of a risk-informed approach, 17 as you just said, is that we want to focus Agency and 18 licensee resources on what's important. Now in reactors, 19 there is a clear need for that, because we are regulating 20 many, many things that are really not important. Is it the 21 same thing here? Do you feel that you impose unnecessary 22 burden on the licensees in some areas that, you know, we may 23- change that by following a risk-informed approach?

24 DR. GARRICK: We shouldn't, but we may. You 25 know --

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l 83 1 DR. APOSTOLAKIS: Have the licensees complained?

'- r L

.2 Like in reactors, I mean, they have complained.

l 3 Oh, they do complain?

i 4 DR. HORNBERGER: No , the reactor --

5 DR. APOSTOLAKIS: Oh, the reactor for sure. Yes.

6 So I'm trying to understand, I mean, if we switch to a 7 risk-informed approach here, what's going to change besides 8 the paper? I don't know.

9 Seth, do you want to comment on that?

10 MR. COPLAN: I wasn't sure whether you were 11 asking.

12 I think, first of all, we're not sure, but there 13 may be some areas where either the risk is worse than we 14 think and the regulations may need to be tighter. More

() 15 likely I think we will find that we may be focusing in some 16' wrong places.

17 And the other thing is that in terms of, you know, 1G just looking at the regulations and how they look, chances 19 are they would not change a great deal as a result of this 20 process. In other words, you know, turning again to the 21 IMNS licensees, for the most part these are not licensees 22 that you can expect to do calculations or that you would 23- want doing calculations.

24 So you'd have criteria that for all intents and 25 purposes looked the same, but the emphasis may be different,

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l l

84 l

1 there might bis requirements that aren't there now, there I

/~' 2

, tg) 1 might be requirements that are there now that would 3 disappear and that sort of thing, but you'd still have Parts l 4 34 through 39 looking pretty prescriptive.

5 DR. APOSTOLAKIS: It's not clear to me that a 6 risk-informed approach or a performance-based approach would 7 change much. So we seem to be doing this just to be 8 consistent, I guess, with what we're doing in other areas.

9 DR. KRESS: Well, I don't know how many resources 10 NRC puts.into policing these things. They certainly could 11 focus their attention there.

12 DR. APOSTOLAKIS: Well, I hope --

13- DR. KRESS: You know, even if the regulations 14 don't change at all --

T 15 DR. APOSTOLAKIS: Yes, that could be.

_j 16 DR. GARRICK: Well, I think that our position l

-17 right now is that even though we're just beginning to get 18 into this matter, that there may be an advantage in us on 19 the basis of what we've' heard here to write a letter and 20 comment principally on SECY-99-100, and we will do that i

21 unless new information suggests otherwise.

22 I think maybe it might be appropriate so that we

'23 can do.that for us to switch to the issue of how the 24 subcommittee is going to work and see if we can get some 25 resolution of that, and I'm going to look to Andy to help,

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I' )

85 1 and maybe Jack Sorensen to help us with this discussion.

() 2 3

I have two pieces of paper here that are kind of critical in this regard. One is a memo that was written by 4 Andy on April 27 to the ACRS and the ACNW that's basically l

5 the minutes, I believe, of our teleconference where we were 6 trying to address procedural issues for a joint ACRS/ACNW 7 subcommittee meeting, and the other thing that I have is an 8 excerpt from something.

9 DR. CAMPBELL: Okay. Let me tell you what that l 10 is. The draft -- the memo which is stamped " Draft" is in 11 your notebook right behind the agenda, in case you don't 12 have a copy of it. It's before Tab 1, just immediately I 13 behind the agenda. But the other piece of paper John 14 referred to is a recommendation from the P&P Subcommittee of O)

( 15 ACRS.

l 16 Behind that is an attempt on my part to take the 17 old draft protocol, which is three years old, and try and 18 update it. I didn't completely have success in that, in l 19 that I still have Tom as Chairman of the ACRS, but other 20 than that, it was an attempt to update the protocol in terms 21 of this memo, this conference call. So the issues before 1

i 22 you are a, b, c, and d recommendations from the P&P 23 Subcommittee, and whether or not the joint subcommittee is 24 going to proceed by those. It's somewhat different than the 25 discussion during the conference call.

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86 1 DR. GARRICK: Okay. Maybe we can address these

. 2- one by one.

3 In the conference call we sort of compromised from 4 the very simple approach of the subcommittee writing letters 5 itself.and the cochairman, whoever may be so designated at 6- -that time, signing those letters, and allowing any Member of 7 either committee to attend,-and as long as they participated 8 in the meeting and the discussions, they were to be a party 9: of the letter.

10 Now I guess that's not enough based on what I'm 11 hearing.

12 DR. APOSTOLAKIS: It's not.

13 There were some strong views expressed at the P&P, 14 Planning Procedures Subcommittee that this is a subcommittee j

() 15 like any other, and it's supposed to do what you announced i 16 -earlier today, namely to collect information and so on and i

17 propose positions to the committees. Some sort of 18 compromise was reached in the sense that -- well, first of 19 all, .the easy part is when we decide that one topic belongs 20 to ACNW, for example. Then this subcommittee doesn't get L21 involved, unless you want some comments from us.

22- But.when we feel that it's a joint-letter, then as 23 I recall we would write a letter, the four of us, we will 24 . agree, you know,.I don't know whether we'll do that through 25 a formal vote or among ourselves. But then that letter will O ANN RILEY & ASSOCIATES, LTD.

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I 87 1 be forwarded to the ACNW and the ACRS and those two

( '2 committees will have to approve, and the review, though, 3 will not be line by line. The review will be on the main 4 points of the letter, and if there is any disagreement or 5 they want to emphasize more one of the points, because if it 6 goes line by line, we'll never really finish. And then they 7 will have to be endorsed.

8 In fact, as I recall, the official letter will be 9 signed by the Chairmen of the two committees, and not the 10 cochairmen of the subcommittee. So in this case it will be 11 Garrick and Powers.

12 Now if the ACRS, for example -- see, that way you 13 give the opportunity to the full Committee to express its

-14 support or disagreement. Now if there is a serious

( 15 disagreement I suspect the letter will come back to the four 16 of us --

17 DR. GARRICK: Yes.

l 18 DR. APOSTOLAKIS: For some compromise. But also I 19 it's very important, individual Members will have the 20 opportunity for added comments.

21 DR. GARRICK: Sure.

22 DR. APOSTOLAKIS: Because if it's only from us, 23 we're not giving them that opportunity.

24 DR. GARRICK: It seems that the success of this 25 approach would be strongly dependent upon the subcommittee

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88 l

1 Members bringing the arguments, the discussion, the basis

() 2 3

for the letter in a very transparent DR. APOSTOLAKIS: Yes.

4 DR. GARRICK: Fashion before the full Committee.

5 DR. KRESS: Yes, because'they will not have had a 6 chance --

7 DR. GARRICK: Right. I 8 DR. KRESS: To hear what the --

9 DR. APOSTOLAKIS: Speaking of a chance, Powers was 10 adamant that there should be a briefing of the full ACRS, so 11 the poor staff would have to do this three cimes if you guys 12 want the same thing. And that's really a heavy burden, 13 unnecessary burden, but he really felt very strongly 14 about --

t 15 DR. GARRICK: Well, I think if you push that to 16 the limit, you're back to two committees.

17 DR. APOSTOLAKIS: You're back to two committees.

18 DR. GARRICK: And there's not much advantage.

19 DR. APOSTOLAKIS: Well, maybe we can again find a 20 compromise, and Tom and I go back to the ACRS and get a 21 briefing.

22 DR. KRESS: Yes --

23 DR. APOSTOLAKIS: And say, you know, this is what 24 we heard, these are the points, and this is the way the 25 subcommittee is thinking of going, and at least it comments l (I) w-ANN RILEY & ASSOCIATES, LTD.

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E 1

1 89 1 from the ACRS itself to bring back to the subcommittee.

1 2 There may be rare occurrences where the ACRS would

)

3 feel they wold need a briefing by Staff but I don't see that 4 happening too often.

5 We'll try to minimize that -- but in principle 6 each committee could demand a briefing. We'll try to 7 minimize that.

8 DR. GARRICK: I think operationally it depends 9 upon what is the reality here. If every time we do this one 10 of the committees demands a briefing, you know, we are i

11 wasting a lot of time. '

12 DR. APOSTOLAKIS: That's right.

13 DR. GARRICK: Of a lot of busy people. The other 14 thing that I guess we have to face up to is is this a

() 15 consensus position or is this an individual position, and 16 how do.you deal with that? I think there comes a point at I I

17 which the consensus has to prevail some way. i 18 DR. APOSTOLAKIS: Another way we are handling it 19 now at the ACRS, and that was based also on the feedback we I i

20 got from the Commission and the Staff, we tried to list only l 21- consensus points in the letters, which meant that a lot of 22 things were eliminated.

23 DR. GARRICK: Yes.

4 24 DR.'APOSTOLAKIS: There was a lot of discussion 25 that if you go to the letter you do not find at all. .

l l

l (_/

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l 90 l' DR. GARRICK: It is in the transcript but not the 2 letter,

( j 3 DR. APOSTOLAKIS: It is in the transcript but not 4 in the letter, and, you know, sometimes you see added 5 comments, but as a rule that discussion is lost, so what we 6 are doing now, we are structuring the letter where we have

)

7 conclusions and recommendations upfront and these are'the 8 clear consensus of the committee, but then they are followed 9 by discussion. This is the National Academy format.

10 DR. GARRICK: Right.

11 DR. APOSTOLAKIS: In the discussion now we try to 12- present different points of view without really commenting 13 on whether this is the consensus of the committee and so on, 14 and at least the Staff finds this very informative, so we

) 15 may want to do the same thing'here and say some members of 16 the committee also are uncomfortable with this because of 17 such and such a reason and leave it at that, but I don't 18 think the letter should be consensus I mean on everything.

19 When the full ACRS reviews those letters, they  ;

i' 20 really-scrutinize the recommendations and the conclusions 21 line by line, commas, periods, semicolons -- but the 22 discussion is paragraph by paragraph, so we don't really go l 23 into the detailed words, and that speeds up the process of 24 course.

25 DR. GARRICK: Yes. Well, I was going to ask you, 1

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b 91 l 1 when you talk about agreeing on the basic points or agreeing i

'N

[d 2

3 on the recommendations, how does that work?

paragraph by' paragraph process?

Is that a 4 DR, APOSTOLAKIS: No. The recommendations are 5 line by line, but they are usually one, two, three -- very 6 short.

7 DR. GARRICK: Yes.

8. DR. APOSTOLAKIS: Certainly they are line by line 9 and I believe that when each committee, ACNW or ACRS, review 10 a letter that we produce they should look at the 11 recommendations and'the conclusions line by line, but the 12 discussion they.should not, because as you say, otherwise we 13 are back to two committees.

14 DR. GARRICK: Right, right. Yes.

() 15 DR. CAMPBELL: Let me just add something here.

11 6 Dana received this draft memo but in that there were a 17 couple of concepts that were discussed at the conference 18 call.

19 One was that any member of either committee could

20. provide comments on any -- for consideration by the

.21 subcommittee of any topic it is reviewing or letter it.is 22 drafting.

23 DR. GARRICK: It's Item 7.

24 DR. CAMPBELL: That was Item 7. The other was 25 .that in terms of voting as it was conceived of during the L

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92 1 conference call, any member of either committee could

[^

(_,} 2 participate in the subcommittee, so for example Charles and 3 Ray today are participating in the subcommittee and under 4 the original idea of a conference call they would have a 5 voting right.

6 You could retain something of that in terms of 7 continuing to invite members of both committees to 8 participate in the subcommittee activities to avoid the kind 9 of situation where you end up with three briefings on the 10 same subject matter of three committees.

11 DR. GARRICK: Well, I think there's some general 12 rules that we ought to be following.

13 One is that we ought to be tapping from each of 14 the respective committees the best expertise we can on the O)

( 15 subject at hand and, two, if somebody has a particular 16 desire to get involved in an issue, whether they are an 17 expert or not they should get involved.

18 DR. APOSTOLAKIS: But in terms of voting though, 19 it seems to me that the first letter should come from the 20 four members of the subcommittee.

21 DR. GARRICK: Yes, so the four members of the 22 committee generates the draft letter.

23 DR. APOSTOLAKIS: Yes, and clearly I mean Ray is 24 not a voting member, but if he says something, the 25 subcommittee will listen, so it is not a matter of saying

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93 1 no, you don't vote.

2 DR. GARRICK: Oh, of course -- and besides which, 3 this process that we are trying to get underway here,'there 4 is going to be a lot of rotation of members and co-chairmen 5 and what have you, and so we are trying to maintain a very 6 collegial approach to the whole process.

7 Well, I haven't studied these thoroughly, Andy.

8 If we were to embrace these can you interpret it for us as 9 to what it means?

10 DR. CAMPBELL: The P and P?

11 DR. GARRICK: Yes, the ACRS subcommittee 12 recommendations. What is different about this than what we 13 have on letter one?

14 DR. CAMPBELL: Well, the main difference is that

() 15 voting will be by either ACRS or ACNW or in some cases both 16 'ACRS and ACNW, full committees.

17 The original concept in the phone conference was 18 that the subcommittee would act as its own subcommittee with 19 a charter and would vote, the four of you or whoever was 20 participating.

21 DR. APOSTOLAKIS: That's different.

22 DR. CAMPBELL: That is a fundamental difference.

23 DR. GARRICK: How do you feel about that, George 24 and Tom?

25 DR. KRESS: Well, you know, it was my original ANN RILEY & ASSOCIATES, LTD.

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1 l

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94 1 proposal that the subcommittee act like an individual view.

f~N 2 DR. GARRICK: Yes.

\.

3 DR. KRESS: I guess some of the discussions on the 1 4 ACRS were persuasive from the point of view that, number 5 one, they didn't think the Commission desired to set up ,

1 6 another independent committee, and number two, that they may 7 not appreciate three sets of views, one from a subcommittee 8 and one from the ACNW and one from ACRS, although that may l

9 not be a likely outcome.

10 Those arguments were persuasive to me, that we 11 probably shouldn' t be putting together another indeper; dent l

12 committee.

13 DR. GARRICK: Yes, but the whole idea here again 14 was to get the two committees to work together, l f%

) 15 DR. KRESS: It was a pragmatic, practical idea.

16 DR. GARRICK: Right, and that there's certain 17 issues -- that without the subcommittee concept there are 18 certain issues that we both address and in theory at least 19 we could be offering different advice and we are trying to 20 at least --

21 DR. KRESS: Yes, trying to avoid that.

22 DR. GARRICK: Yes, so the real trick here is going 23 to be able to implement this additional complication and get 24 something done, be able to get something done.

25 DR. KRESS: I think, without -- George and I being

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n-95 1 very persuasive in discouraging this business of ACRS --

. [~ -2 they need to hear everything that the subcommittee heard

-3 from the Staff over again, I think that would be the part 4 that would just not be at all workable.

5 DR. GARRICK: Yes.

6 DR. KRESS: We have to get around that part some

7 way.

8 ?R. GARRICK: Yes. I wonder if we shouldn't even

~

9 say something like,that.

10 DR. KRESS: In the write-up?

11 DR. GARRICK: In the write-up.

12 DR. KRESS: Yes. Probably it ought to be better 13 to have it explicit.

14 DR. APOSTOLAKIS: Say something like what?

()

s 15' DR. GARRICK: Say something like every attempt 16' will be made to avoid-the need for presentations to the two l 17 committees independently.

18 DR. KRESS: Through the use of summaries --

19 DR. GARRICK: Or something of that nature.

20 DR. CAMPBELL: In terms of procedures that could 21 be accomplished by having the lead member of the 22 subcommittee for a particular letter or a particular issue 23 address the ACRS or the ACNW, as the case may be, or both 24' committees and then have the Staff available to answer 25 questions but not require that they have to prepare a l

\

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96 1 presentation because, you know, part of the FTE impact on 2 the Staff is going through the whole process of preparing

'\()~T l 3 presentations.

I 1

! 4 DR. KRESS: That's a good suggestion.

5 DR. GARRICK: Can you represent that in words?

6 DR. CAMPBELL: Yes. I will put something together 7 and run it by -- well -- I'll get it out to you on e-mail 8 would probably be the best thing, if that is okay with John 9 Larkins.

10 DR. GARRICK: Okay. Now as far as the issue of 11 the signatures of the two chairman, does anybody have a 12 problem with that?

13 DR. HORNBERGER: No , but it does strike me that 14 the Item C is really the one that is important. It strikes A *

.%]

f 15 me that if we decided that it were either an ACNW or an ACRS 16 matter, it would be more like acknowledging that we wanted 17 consultation from someone with expertise on the sister 18 committee, and Item C is really where the -- I don't think 19 that we would welcome going to more meetings if it weren't 20 truly something of interest to both committees, and 21 therefore that is -- it all depends on how it plays out.

1

. 22 If both committees insist on going through it line 1

23 by line, it is going to die. It's just going to die.

24 DR. GARRICK: So are you suggesting maybe some l 25 modification to Item C?

l

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1. DR. HORNBERGER: No , not at all, just an h

v 2 acknowledgement that it is just going to depend upon the 3 individuals being willing to recognize that, okay, this is 4 the way we are going to do it, but there are pragmatic 5 considerations that, as George said, go through the ,

6- recommendations and conclusions line by line because you are 7 signing on to that. They are the important.part but to 8 not -- because if we have to go back and forth and back and 9 forth four times amongst the committees, first of all we 10 will never get a letter out. Second of all, we will get _

11 worn out. We won't want to participate in those.

12 DR. GARRICK: Right, okay -- so my summary of 13 where we are is that Andy is going to make an attempt to 14 consolidate the two sets here of guidance that we have, with

, 15 the additional narrative that we referred to earlier.

16 DR. CAMPBELL: Okay. I think --

17 DR. APOSTOLAKIS: I want to make one comment.

l 18 DR. GARRICK: And get that out to us for 19 consideration.

20 DR. APOSTOLAKIS: To avoid problems in the future 21 it is always best to bring the stakeholders into the process

22. early, so what I think we should do is Tom and I should 23 inform the ACRS in June that this subcommittee is about to 24 prepare a letter with these five points we mentioned, and l 25 maybe we should half an hour for a committee meeting or 45 D ANN RILEY & ASSOCIATES, LTD.

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98 1 minutes to discuss this and see whether the members

() 2 3

disagree, agree, they don't think it is the right list --

DR. GARRICK: You mean the procedure?

4 DR. APOSTOLAKIS: No. No, the letter we plan to 5 write -- about principles and language and so forth.

6 DR.'GARRICK: All right, all right.

7 DR. APOSTOLAKIS: So we prepare them that, hey, 8 this is coming -- you are going to see it in July or August.

l 9 DR. GARRICK: Yes. .

I 10 DR. APOSTOLAKIS: And maybe we will get some 11 useful input. I think that will help.

I 12 DR. KRESS: Maybe if we had a draft all ready by 13 then.

14 DR. APOSTOLAKIS: Well, I would rather do it

( 15 before there is a draft, for psychological reasons.

16 DR. KRESS: Okay.

17 DR. APOSTOLAKIS: I mean if you have a draft l

18 that's great, but it is a " rough" draft.

19 DR. KRESS: Very rough.

20 DR. APOSTOLAKIS: But I think that would be very 21 helpful, to give them, you know, we are thinking of putting 22' down these recommendations, what do you think? Because we.

23 just went through a similar debate when we were talking 24 about the overarching principles, and maybe there will be 25 'some good ideas. You never know.

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F 99 1 DR. KRESS: Oh, absolutely.

/" 2 DR. APOSTOLAKIS: The important thing is not to k -}/

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3 ' surprise people with a letter.

4 DR. GARRICK: Do we want to talk about what we ,

I 5 want to put in this letter for a few moments -- }

6 DR. APOSTOLAKIS: Sure.

7- .DR. GARRICK: -- at'this point in the way of 8 recommendations.

9 We've already identified something in the way of a 10 first principle, namely that we ought to be thinking as far i

11 as risk measures are concerned in terms of dose as the i 12 parameter, and -- a risk parameter. I 13 DR. APOSTOLAKIS: Is that really something we want 14 to bring up in this letter?

l

() 15 16 DR. GARRICK: Well, I don't know.

DR. KRESS: I think that's the right way to go. i 17 It's a good time to bring it up.

18 DR. APOSTOLAKIS: Dose.

19 DR. KRESS: As a surrogate for risk.

20 DR. APOSTOLAKIS: I thought we were talking about 21 higher level.

22 DR. KRESS: Frequency and dose.

23 DR. GARRICK: Yes, it's not just dose.

24 DR. APOSTOLAKIS: Oh , so what you're saying is 25 stay away from estimating individual risk and --

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100 1 DR. GARRICK: Right. Right.

f~}

V 2 DR. KRESS: And cancers --

3 DR. APOSTOLAKIS: Oh, oh, oh.

4 DR. GARRICK: Yes. All we're saying is that --

5 DR. KRESS: That is a principle.

6 DR. GARRICK: We'll do either a PDF of dose or a 7 CCDF. Yes.

l 8 DR. APOSTOLAKIS: The surrogate goals, I mean, we l l

9 can perhaps recommend that the staff think about it, but to l 10 actually say what they are at this point.

11 DR. HORNBERGER: Well, I mean, the decision we 12 have to make is whether we're going to recommend principles 13 or whether we're going to recommend that the staff think 14 about what the principles should be.

(3 15 DR. APOSTOLAKIS:

() That's right. Maybe that's the 16 first step.

17 DR. HORNBERGER: And if we're going to do this in 18 short order, then I think that we ourselves are not going to 19 put forward the principles, we are going to perhaps give 20 some for examples.

21 DR. APOSTOLAKIS: Exactly.

22 DR. GARRICK: All right. Then it seems to me what 23 we're going to have in this letter is, number 1, a 24 recommendation that the staff develop those principles and 25 maybe give an example so as to convey to them when we talk

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~-

I 101 l 1 about principles what we mean, and, number 2, maybe some

~

2 brief comments on this document itself, including the (w

3 categorization of activities that they have done and some of l 1

4 our thoughts about that. Number 3, some discussion of l 5 methods and the need to perhaps illustrate the continuity of 6 the methods from one category to another, that it's not so 7 much a discrete individual method for one category versus a l 8 discrete individual method for another category, it's more a 9 matter of degree and scope than it is kind and fundamental 10 thought process. So those are the kind of things --

11 DR. HORNBERGER: Okay. Now, John, on that last 12 one, is that different from the language, or is that part 13 and parcel?

l 14 DR. GARRICK: I think it's part of it, but the I (m) x_/

15 language should be part of this too, because we've commented 16 on it, we've discussed it --

17 DR. HORNBERGER: Well, as a white paper.

18 DR. GARRICK: Yes. Yes. Yes. So -- and usually 19 what we try to do after we discuss what we want to put in a 20 letter, we put the finger on somebody to say okay, on the 21 basis of what the Committee has discussed, would you be so 22 kind as to try to generate a first draft? Is there any 23 reason why that procedure wouldn't work here, and is there a 24 volunteer?

25 DR. HORNBERGER: Is there an alternative to that

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c:

102 1 procedure?

() 2 3

DR. APOSTOLAKIS: Well, do you want to also include the need for quantitative objectives?

i 4 DR. GARRICK: For what?

5 DR. APOSTOLAKIS: Quantitative objectives, safety 6 goals.

7 DR. GARRICK: Oh, yes. Right, right. The issue

! 8 of safety goals. Right.

9 DR. HORNBERGER: The safety goals. Make sure we 10 get the language.

11 DR. APOSTOLAKIS: That's right.

j 12 DR. KRESS: That and the metric one.

l 13 DR. APOSTOLAKIS: Right.

14 DR. KRESS: Well, it sure wouldn't upset me very

() 15 mach if you made a stab at this draft, John.

I 16 DR. APOSTOLAKIS: -I'll second that.

17 DR. HORNBERGER: We have a volunteer.

18 DR. APOSTOLAKIS: I move that John Garrick 19 volunteer to do this.

20 DR. KRESS: He has a way with words anyway.

21 DR. GARRICK: I think that's unfair, but -- okay, 22 we'll try to put something together and get it out to the ~ l 23' Members.

24 Very good. Any other issues, topics, relative to 25 the Subcommittee process from either the Committee, the

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J

103 1 staff, or the NRC' staff that we want to bring forward at

( 2 .this point?

)

3 MR. COPLAN: Not from the NRC staff.

4 DR._GARRICK: Okay. Then I think unless we have 5 'such comments, we will adjourn. Okay?

6 (Whereupon, at 11:43 a.m., the meeting was 7 concluded.]-

8 9 ..

10 11 12 13 14

() -15 16 17 18 19 20' 21 22 4

23 24 25

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REPORTER'S CERTIFICATE lI This is to certify that the attached proceedi.gs be' fore the. United States Nuclear Regulatory Commission in O]*

\

l the matter of:

1 NAME OF PROCEEDING: MEETING: ACRS/ACNW

)

JOINT WORKING GROUP t

CASE NUMBER:

PLACE OF PROCEEDING: Rockville, MD were held as herein appears, and that this is the original transcript thereo: for the file of the United States Nuclear Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and ,

accurate record of the foregoing proceedings.

,1 bbk l'%

Mark Mahoney Official Reporter Ann Riley & Associates, Ltd.

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1. %, UNITED STATES 8 o NUCLEAR REGULATORY COMMISSION I. '

• $ I Advisory COMMITTEE oN NUCLEAR WASTE WASHINGTON. D.C. 20886 O*%...../

April 27,1999 SCHEDULE AND OUTLINE FOR DISCUSSION 109" ACNW MEETING MAY 11-13,1999 Tuesday. May 11.1999. Two White Flint North. Room 2B3.11545 Rockville Pike. Rockville, Maryland

1) 8:30 - 12:30 P.M. Joint ACRS/ACNW Workina Group on Risk-Inforned Reaulation (Open) (Apostalakis/Kress/Garrick/Homberger-Sorensen-Campbell)

The joint working group will discuss a framework for risk-informed regulation in NRC's Office of Nuclear Material Safety and Safeguards 12:30 - 1:30 P.M. " LUNCH"

2) 1:30 - 3:30 P.M. ACNW Plannina and Procedur93 (Open) (BJG/RKM)

O 2.1) Preview issues for 109" ACNW meeting '

2.2) Finalize agenda for 110* ACNW meeting, June 28-30, 1999 in San Antonio, Tx 2.3) Review EDO responses to Committee letters 2.4) Recer:t and planned attendance at outside meetings 3:30 - 3:45 P.M.

• BREAK"

3) 3:45 - 5:30 P.M. Yucca M >untain Review Plan (Open)(GMH/HJL)

The NRC staff will describe the strategy for converting the Issue Resolution Status Reports for the proposed high-level repository at ,

Yucca Mountain into a review plan for the repository license application -(Christiana Lui) 5:30 P.M. RECESS Wednesday. May 12.1999. Two White Flint North. Room 2B3.11545 Rockville Pike, Rockville. Maryland l l

4) 8:30 - 12:30 P.M. Risk Communication (Open) (BJG/LGD)

The ACNW will discuss recent expe4nce and plans for improving risk communication and public outreach with representatives of the:

O a) The envirenmentai ereiectien *9encv

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t' t 109* ACNW MEETING . 2 b) The NRC staff c) The Nuclear Energy Institute 12:30 - 1:30 P.M. " LUNCH"

5) 1:30 - 3:00 P.M. Meeting wdh N7tC's Executive Director for Doerations. (EDO) Dr.

William D..Trasers. and NRC's Deoutv Executive Director for Raoulatory Proorams. (DEDR) Mr. Frank J. Miraalia, (Open)

(BJG/RKM)

The Committee will meet with the EDO and DEDR to discuss items of mutualinterest. -

6) 3:00 - 5:30 P.M. Preparation of ACNW Reports (Open)

Discuss a possible report on the following topics:

6.1) Low-Levels of lonizing Radiation (GMH/HJL-MLT) 6.2) White Paper on Repository Design (CF/LGD) 6.3) Waste Related Research and Technical Assistance (GMH/HJL) 5:30 P.M. RECESS Thursday. May 13.1999. Two White Flint North. Room 283.11545 Rockville Pike.

Rockville. Maryland

7) 8:30 - 4:00 P.M. Continue preparp+ ion of ACNW reoorts noted in item 6 (Open) 4:00 P.M. ADJOURN NQIE:

e Presentation time should not exceed 50 percent of the total time allocated for a specific item. The remaining 50 percent of the time is reserved for discussion.

e Number of copies of the presentation materials to be provided to the ACNW - 35.

• ACNW schedules are subject to change. Presentations are frequently canceled or rescheduled to another day. If such a change would result in significant inconvenience or hardship, be sure to verify the schedule with Mr. Richard Major at (301) 415-7366 between 8:30 a.m. and 5:00 p.m., several days prior to the meeting.

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V SCHEDULE AND OUTLINE FOR DISCUSSION ACRS/ACNW JOINT WORKING GROUP MAY 11, 1999 TUESDAY, MAY 11, 1999, TWO WHITE FLINT NORTH, ROOM 2B3, 11545 ROCKVILLE PIKE, ROCKVILLE, MARYLAND

1) 8:30-8:40 a.m. Opening Remarks (BJG/TSK)

2) 8:40-10:00 a.m. Discussion with the NRC staff.on a framework for risk informed regulation of nuclear materials applications. . (C. J. Paperiello, S. M. Coplan)

3) 10:00-10:15 a.m. Break  ;

4) 10:15-11:30 a.m. Continuation of discussion with the NRC staff on a framework for risk informed regulation of nuclear materials applications.

5) 11:30 a.m.-noon Discussion of organizational matters by Q

V joint working group members, including adoption of working group procedures.

i

6) 12:00 noon Adjourn l

l c: ACRS Members ACNW Members ACRS/ACNW Staff O

= = __ _ _ _ _ ___ _ ___ _ __ _ _. _,

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POLICY ISSUE 1 (Notation Vote)

March 31.1999 SECY-99-100 FOR: The Commissioners FROM: William D. Travers Executive Director for Operations

SUBJECT:

FRAMEWORK FOR RISK-INFORMED REGULATION IN THE OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS PURPOSE:

To (1) address commitments made by the staff in SECY-98-138 and (2) request Commission approval of: (a) the staff's proposal to implement the framework for using risk assessment in regulating nuclear material uses and radioactive waste disposal; (b) the staff's proposed approach for addressing risk management issues in those areas and, in particular, its O= development of risk metrics and goals; and (c) the formation of a joint Advisory Committee on Reactor Safeguards (ACRS)/ Advisory Committee on Nuclear Waste (ACNW) subcommittee to provide technical peer review of the staff's future efforts.

SUMMARY

This paper addresses commitments made by the staff in SECY-98-138. It describes the results of an effort to scope the development of a frameviork for applying risk assessment menods to the regulation of nuclear material uses and waste disposal and makes recommendadons to the Commission on how to proceed. It first discusses the risk assessment considerations that were '

CONTACT: Seth M. Coplan, NMSS/DWM (301) 415-5873 O

'N

?,f The Commissioners 2 to comprise the scoping effort (i.e., an association of risk assessment methods with nuclear material uses and the regulatory use of such risk assessment methods). It next describes a

. proonsed framework, steps for implementation of that framework, and reports the staff's canclusions about the value of current "Probabilistic Risk Assessment (PRA) Implementation Plan" activities in consideration of the proposed framework. The paper then discusses risk management issues related to nuclear material use and disposal, including the development and establishment of appropriate risk metrics and goals as part of implementing the framework.

Finally,'it discusses stakeholder involvement, technical support, and peer review. It recommends that the Commission approve (1) the staff's proposal to implement the framework and (2) formation of a joint ACRS/ACNW subcommittee to provide technical peer review of the staff's future efforts.

BACKGROUND:

in SECY-95-280, the staff informed the Commission of its framework for applying PRA in reactor regulation. This framework provides a general structure to ensure consistent and appropriate application of PRA methods in regulating nuclear reactors. Since the reactor framework was transmitted in November 1995, the offices of Nuclear Reactor Regulation (NRR) and Nuclear Regulatory Research (RES) have made substantial progress toward completing the six-step process that was envisioned to implement it.

In its staff requirements memorandum (SRM) of April 15,1997, about risk-informed (Rl) and O

(1) performance-based (PB) regulation, the Commission included direction nuclear material uses to assure that the needs of those licensees and areas receive adequate consideration; (2). review the bases for nuclear materials regulation to identify areas that can be made amenable to RI or PB regulation with minimal additional retources; and (3) develop a framework for apply:ng PRA to nuclear material uses similar to ths reactor framework. SECY-98-138 provided a preliminary response to the SRM. The staff concluded that the first two of these requests could not be addressed fully until a framework had been at least partially developed. The staff further concluded that: (1) the reactor framework was not directly applicable because of differences among the activities regulated by the Office of Nuclear ,

Material Safety and Safeguards (NMSS) and collectively between those activities and reactors; '

and (2) development of an appropriate framework could be a substantial effort that would need to involve the Agreement States (AS') and other stakeholders. The staff informed the Commission that, given U.S. Nuclear Regulatory Commission's (NRC's) available resources, it would first use a task group (TG) to scope the development of a framework, estimate the requisite resources, and make a recommendation to the Commission on how to proceed. For the scoping effort, the staff proposed to: (1) make a preliminary association of risk assessment methods with regulated uses of nuclear material; and (2) as appropriate for each regulated use and in coordination with the AS', make a preliminary identification of how the associated risk assessment method could be used in a risk-informed regulatory framework for nuclear materials regulation.

Part of the staff's response to the April 15,1997 SRM was the establishment of e NRC/AS' Workmg Group, the Nuclear Byproduct Material Risk Review (NBMRR) Group, to identify and d

,O aocumention ai a fortechnical basis 9r o o aaro ca tofor a risk-informed

< sei tie ef's 1 m t ri i approach to regulation

1. ies ri * >#ferm tie #. ^ of certain m i

i The Commissioners 3 O compar) ion paper, SECY-99-062, " Nuclear Byproduct Material Risk Review," describes, in greater detail, one of the risk assessmer:t methodologies that is discussed in this paper. Earlier papers provided detailed descriptions oi other risk assessment methodelegies thct are discussed in this paper and appy principally to applications of nuclear materials. More specifically, SECY-94-228 descthd performance assessment (PA) and SECY-98185 described integrated safety analysis (ISA). '

i DISCUSSION:

The staff has completed the proposed scoping effort using a TG drawn from each of the divisions of NMSS and from the offices of NRR and RES' (the TG members and their organizational affiliations are listed in Attachment 1). This paper die-- the results of the scoping effort and makes recommendations to the Commission on a framework for the use of risk assessment in nuclear materials regulation. These recommendations address issues related both to risk assessment [i.e., the variety of assessment methods that are now in use or could be used (and how these are or might be used) in RI regulation) and risk management (i.e., the establishment of metrics and gesis for risk to appropriate individuals or groups). The framework proposed is consistent with the Commission's "PRA Policy Statement" and, at a high level, parallels the framework adopted for reactor regulation. The objectives of the materials framework are the same as for the reactor framework: (1) enhance safety by focusing NRC and licensee resources in areas commensurate with their importance to health and safety; (2) provide a framework for using risk information in all regulatory matters; and (3) allow use of risk information to provide flexibilhy in licensing and operational areas. Although risk management

-O i r tid "i o a 't ria c ai#a aort'" seov-aa-'aa.ta v r d' cu di" t

this paper bar:ause the staff found that uses of risk assessment to meet these three objectives in regulating nuclear materials could be limited by an important policy gap relative to the reactor situation.' Specifically, the Commission's " Safety Goals for the Operations of Nuclear Power Plants Policy Statement" established important risk metrics and goals for the reactor program and in that way provided a risk management foundation for subsequent use of PRA. No similar policy statement exists for material uses and disposal and, in consequence, the need to consider development of an analogous foundation is discussed in this paper.

Association of Risk Assessment Methods with Nuclear Material Uses Broadly, the activities regulated by NMSS can be categorized in four groups: (1) activities that involve long-term commitment of a site or facility to the presence of nuclear material at a planned, acceptable level (e.g., HLW disposal); (2) activities that involve use of engineered casks to isolate nuclear material under a variety of normal and off-normal conditions (e.g., '

transportation and storage); (3) activities that involve physical and chemical processing and possession of nuclear material at a large-scale facility (e.g., fuel fabrication); and (4) activities that involve the use of either sealed or unsealed byproduct material in a wide variety of industrial and medical applications. Not surprisingly, these groups correspond clooely to the organization of NMSS. Their differences frorrmne another include: the facilities, systems, or devices employed; potential exposure pathways; potential accident initiators and frequencies; '

potential consequences; and populations at risk. Systematic analysis of these specific features

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closely related NBMRR along with being kept informed of TG progress would meet their needs adequately.

The Commissioners 4 i

is the crux of any risk assessment that might be applied to en NMSS-regulated activity. i Therefore, different risk assessment methods are more efficient and effective for the activities of each group. Such methods have been developed or adapted from methods used for other similar technologies as the need has arisen. Accordingly, the degree of development of and i experience in using these methods differs.

L Geologic disposal of radioactive wastes, site cleanup, and mill tailings reclamation constitute  ;

group 1. Starting in the mid-1970s, the staff has been a developer of PA methodology for the assessment of risk associated with deep geologic disposal of HLW, land disposal of low-level radioactive wastes (LLW), and residual site contamination after decommissioning. From the beginning of the HLW and LLW programs, it was recognized that risk insights that can be uerived using PA are particularly well-suited to address issues that arise from the long-term - l nature of HLW and LLW disposal. Thus, NRC's existing regulations for deep geologic disposal i of HLW (10 CFR Part 60) and land disposal of LLN (10 CFR Part 61) both anticipate the use of PA methodology to show compliance with long-tum performance objectives for those facilities.

A similar reliance on PA is an essential feature of sne-specific regulations that are now being developed for HLW disposal at Yucca Mountain (10 CFR Part 63). More recently, NRC amended 10 CFR Part 20 to establish criteria for residual contamination at decommissioned sites. The staff is currently developing risk-informed guidance to implement these criteria.

Transpoitation and stomge, particularly of spent fuel, comprise group 2. The staff made early 3 efforts to apply risk usessment methodology for the analysis of transportation risk-most O ^ notably, the " Final Environmental Statement on the Transportation of Radioactive Maten

<~uase-oi7o). e shiani 9 co i i < ae peo te s vere siaa- v and Railway Accident Conditions"(NUREG/CR-4829, also known as the " Modal Study"). More recently, the staff has applied PRA methodology in deciding to approve the one-time shipment of the Trojan reactor pressure vessel, with intemais, for disposal at the U.S. Ecology site in the State of Washington. Also, the staff has nearly completed its re-validation of NUREG-0170 in light of proposed shipments to a repository (vs. reprocessing). The re-validation effort should be completed by the last quarter of fiscal year (FY) 1999 and includes a computer evaluation of cask response to severe accidents and probabilities, the use of current health effects models, and studies of population distributions about likely shipment routes. The staff intends to use the  ;

results of the NUREG-0170 re-validation in its efforts to update the Modal Study for the new l generation of dual-purpose cask designs. The Modal Study update will focus on confirming l severe accident probabilities and effects and will likely include partial or full-sca:e package  !

tests. Moreover, the staff intends to encourage more Rl decision-making with the U.S.

Department of Transportation and the Intemational Atomic Energy Agency (IAEA). The staff believes that ISA and PRA are both appropriate risk assessment methodologies for transportation.

Dry cask storage is the other major group 2 actmty. The staff thinks that ISA or PRA can be an appropriate risk assessment tool for this activity as well. At one point, the staff wanted to apply PRA to dry cask storage systems with staff and contractor resources, but suspended the  !

project when the resources were needed for high-p;)ority licensing ane: certification efforts. In lieu of this broad project, an initial ISA was developed by the staff for one particular dry cask storage system which, in essence, was a general scoping risk assessment of the vulnerabilities

' of this cask system. The report is currently under peer review and will be issued later this year. l I

e6

., 1 The Commissioners 5 O Although this appears to be an effective early risk assessment, further development of an ISA or PRA will be constrained, based on available staff resources.

Fuel fabncation, uranium enrichment, and mining and milling of source material exemplify group

3. There are several ongoing efforts to develop appropriate risk assessment methods for the processes included in this group. First, the staff and the major fuel cycle licensees have adapted risk assessment technology that was developed for the chemical process industry after the Bhopal accident. This adaptation, ISA, has proven to be an integrated hazard identification and assessment methodology for major fuel cycle facility operations. The staff and these )

licensees have been working to develop a regulatory approach using ISAs, and substantial progress has been made in that regard. In June 1999, the staff expects to transthit proposed revisions to 10 CFR Part 70 incorporating this approach for Commission approval. These proposed revisions will be the result of extensive staff and industry consideration of how the ISA concept should be applied to fuel cycle facilities, and the staff expects that it will be generally supported by the industry. Second, the staff and the U.S. Department of Energy (DOE) plan to use ISA technology to support design and operation of the pre-closure facilities related to a geologic repository for HLW. Such use is incorporated in the proposed Part 63.- The staff is sponsoring a project at the Center for Nuclear Waste Regulatory Analyses (CNWRA) to l develop guidance for the review of the pre-closure safety analysis for the repository, based on the ISA methodology. Finally, the CNWRA is starting a project to assess the risks associated with in situ leach extraction of Uranium. Risk insights gained from this project will be used to support risk-informed rulemaking for such facilities.

O i#e# tri ir d' ear a*v.e#ci r- eicio . #e il-ieaaima -aiifv are#9 4. wi'a r n ct te risk assessment, the situation regarding the wide variety of activities in this group is complex.

In the early 1990s, the staff tested the use of PRA methodology to study the risk associated with a new medical procedure (gamma stereotactic surgery). The results were positive, but the approach was expensive and had some significant limitations. Although the PRA correctly predicted human error to be the principal accident initiator, the fault tree / event tree methodology was an inadequate tool for analyzing such accidents. Recently, the staff started the NBMRR in partial response to the SRM of April 15,1997. The principal objective of the NBMRR was to develop the basis for a risk-graded approach to regulating the activities in group

4. This involved the development of appropriate risk assessment methods to address these activities. The staff believes that the project has resulted in significant progress in that regard and has provided the Commission with a more detailed description in SECY-99-062, " Nuclear Byproduct Material Risk Review," dated March 1,1999.

Definitions of these risk assessment methods and a table that displays their specific association i with the activities comprising these four groups are provided as Attachinent 2 to this paper.

Use of Risk Assesement Methods in a Risk-informed Renulatorv Framework The "PRA Policy Statement" provides general guidance on what regulatory use should be made of risk assessment. Implementation of this general guidance can be accomplished by a variety of approaches involving staff and licensee use of risk insights and risk assessment in regulatory l decision-making. In each case, there are two principal considerations: (1) What specific tse is the staff expected to make of risk insights and risk assessment in development of regulations and guidance, licensing, inspection, assessment, and enforcement? and (2) What specific use

1

. j The Commissioners 6 '

~

. is the licensee expected to make of risk insights and risk assessment in planning and conducting its operations? A number of factors are important to these two considerations.

They relate primarily to what can be gained in terms of safety and reduction of regulatory burden, on the one hand, versus the cost of transition and ultimate implementation, on the oth'er. These factors were discussed in SECY-98-138 and include: hazard and complexity of l the activity, degree of human involvement in the activity, technical sophistication of the licensee community, NRC staffing and training issues, AS issues, and others. Consideration of these factors in the context of the full variety of NMSS-regulated activities must involve stakeholders 1 and can be expected to. result in a number cf specific approaches, each of which would be f appropriate for the specific activity Some of these approaches make or will make qualitative I use of risk assessnent to supplement traditional approaches (e.g., approach for regulating low-activity, sealed sources); others make or will make quantitative and more sophisticated use of such methods (e.g., the HLW approach). A tabulation of current staff thinking regarding such approaches is provided in Attachment 3. This tabulation was developed only as part of the scoping effort. It is preliminary and is likely to change substantially as the framework proposed 1 below is implemented. l A Proposed Framework During its deliberations about the appropriate scope of a nuclear materials framework, the TG developed a framework that is applicable to the materials area. This framework, described in Attachment 4, is similar to the reactor framework, but adopts a lower level of specificity. Like the reactor framework, it is a high-level structure that leaves the particulars of establishing and OL implementing specific risk-informed approaches to a series of implementation steps. These steps are also described in Attachment 4. Progress toward completing them would be reported and tracked in the "PRA Implementation Plan." With Commission approval, the staff will begin implementation of the framework described in Attachment 4.

Current PRA Imolementation Plan Activities in Consideration of the Framework The SRM of April 15,1997, requested that the staff re-examine its Rl/PB approaches with regard to nuclear material licensees and to HLW issues, to ensure that the needs of those licensees and those areas receive adequate consideration. In Attachment B to Attachment 1 of SECY 98-138, the staff provided its preliminary response by re-examining the approaches that are supported by Tasks 4 and 5 of the "PRA Implementation Plan." The staff considered this response to be preliminary because it believed that some conclusions and priorities could have changed as work on a framework progressed. The staff now has re-examined these same approaches, given its proposed framework, and sees no reason to change its preliminary l analysis and conclusions. Moreover, as is discussed above, the staff now expects to add activities to the "PRA Implementation Plan" if the Commission approves its framework.

Risk Manaaement Risk management for NMSS must achieve the overall regulatory goal--safety in the use and disposal of radioactive material. A fundamental element of risk management is to determine which risks to estimate [what are the risk metrics (i.e. what activity produces the risk, what

? individual, group, or property receives the risk, what conditions produce M risk)) and to

.' determine what limits are acceptable (i.e., risk goals) for these various risks. In addition risk 1

I

o - The Commissioners 7' management would involve using risk insights to evaluate and manage aspects of the

. regulatory program in various programmatic areas,~ such as licensing, inspecten, and rule changes.

Risk Manaoement Metrics and Gamle for Nuclear Material Uses and Dianraal In developing risk metrics a fundamental aspect is whether the risk arises from normal '

operations with the attendant low-level exposure of workers and the public or whether the risk arises from upset or accident conditions [this is designated, normal exposure and potential

. exposure by the Intemational Commission on Radiation Protection (ICRP)]. For both power reactor operation and material uses, the risk metrics and goals have been established for normal operations by intemational and national standards-setting organizatiohs (such as ICRP -

and the National Committee on Radiation Protection and Measurements (NCRP)) and further incorporated into law and regulation. For upset and accident conditions at power reactors, the

' Commission's " Safety Goals for the Operations of Nuclear Power Plants Policy Statement' establishes two qualitative safety goals that are supported by two quantitative health objectives (OHos). The OHOs are supported, in tum, by two subsidiary risk goals for core damage frequency and large early release frequency. Although it is attractive to consider the OHOs and analogues of the subsidiary risk goals for material risk management, this is not feasible, because of differences in the population at risk, the number of uses regulated, the nature and behavior of the systems regulated, and hazards posed by reactors versus material uses.

Therefore, the materia!s program must develop its own set of safety goals. Furthermore, because of the substantial differences among the various material uses, separate safety gos's h for each activity regulated under each program area must be contemplated. It should be noted that this approach could result in different risk goals (or levels of protection) being applied to different regulated activities; however, any such goals would provide reasonable assurance of adequate public protection.

At a minimum, the risk metrics and goals must address the safety of workers and the general  !

public for normal operations, it should be noted that, in the materials area, the risk associated '

with normal operation (especially for workers) tends to be large compared with the risk from accidents (e.g. see Table S-4,10 CFR 51.52). Metrics and goals for normal operations have  :

been established in terms of radiation dose. They apply for all activities and sources  ;

and include:

i Populatien at Risk Risk Metric Risk Limit Regulation Workers Annual dose Part 20 0.05 Sv (5 rem) and ALARA8 Pub c Annual dose Part 20 1 mSv (0.1 rem) and ALARA Under the overarching public risk limit, more restnctive limits have been established or are being considered for specific activities or sources. For example, a 0.25 mSv/ year (25 mrem /yr)

O 8 A1. ARA is the acronym for "as low as is reasonably achievable."

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The Commissioners 8 and ALARA limit has been established in Part 20 for public doses from residual radioactivity at formerly licensed sites and a 0.25 mSv/ year (25 mrem / year) and ALARA limit has been established in Part 61 for public doses resulting from land disposal of LLW. Similarly,0.01 mSv/ year (1 mrem /yr) is being considered as a limit for public doses as a result of recycling of previously contaminated material.

The challenging part of establishing risk goals for materials uses, as for reactors, will be the upset or accident gc als. In developing the reactor safety goals, NRC considered such factors as the population at risk surrounding each reactor, the number of reactors, and probability of severe accidents at those reactors. These same factors are important for establishing materials safety goals. For materials, the population at risk depends on the specific use, is quite variable, and can be quite large. For example, a large portion of the entire U.S.

population is at risk from transportation accidents; a smaller, but still large population group is at risk from medical procedures (primarily from diagnostic procedures). In contrast, the population at risk from the proposed repository at Yucca Mountain is comparatively small. The number of material licensees (-20,000) and number of sources for potential accidents are large compared with the number of power reactors (~75). Becsose there are so many more regulated sources, even if the accident rates were comparable to reactor accident rates, the numbers of incidents would be much larger. Since some of these accidents could be, and indeed have been, fatal, the safety goals for material uses must consider the large numbers involved and the likely adverse public reaction that a numbar of radiation-induced fatalities wouki engender, even if the risk were low. On the other hand, few material uses involve as much radioactivity as a power reactor and none has the high temperature and pressure that O co miria#' io ia ar

• r a ra of ta r cier "rc

• r '" # .ta ri

• power reactors derives primarily from low-probability, high-consequence, events, whereas the oc' t a -i'a risk from material uses and disposal derives primarily from higher probab:!W, low-consequence, events. Because of these differences in the nature of the risks, it is appropriate to use different safety goals and different risk management strategies in the two arenas. Some risk metrics that might be useful for materials uses include: (1) overall risk of individual fatality from a panicular material use for the appropriate population at risk (both workers8 and members of the public); (2) frequency of large exposures [e.g., exposures in excess of the dose limit for Abnormal Occurrence reporting-0.25 Sv/yr (25 rem / year)) for a particular material use; (3) the maximum dose possible from a particular material use given reasonably conservative assumptions (i.e., a dose cap); and (4) the probability of a criticality event at a facility using fissile material. It is premature to suggest risk goals to correspond to these metrics.

In addition to these substantial technical issues, a number of other factors must be considered in developing specific risk management strategies and the risk-informed regulatory approaches j that would incorporate such strategies for materials regulation. First, developing, setting, and  !

implementing radiation protection standards is shared by NRC with other stakeholders, including: (1) the U.S. Environmental Protection Agency (EPA) and other Federal agencies; (2)

State govemments (which, in some specific cases, have statutory authority to set and implement more restrictive standards than those established by EPA); and (3) independent i

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• It should'be noted that the safety goals for reactors do not address worker safety. For many, if not most, material uses, the risk to workers is the pnncipal aspect of the risk and, therefore, much of NMSS' regulatory effort is directed j toward worker protechon from both accdonts and normal exposure Acw,(-Gy, risk metrics and goals for nucisar i metenal uses would address worker e me./h, from accdonts, l l

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The Commissioners 9 O standards-setting entities such as ICRP, NCRP, and IAEA. Therefore, NRC must accommodate these shared functions in developing a risk management approach and assure an appropriate level of communication with, and acceptance by, these stakeholders. Second, material licensees have a quite variable level of capability in risk assessment, different levels of r

esources available for all regulatory matters, and different levels of interest in pursuing a risk-informed approach. Except for a few such licensees (e.g., the DOE Yucca Mountain Project),

material licensees do not have a significant capability in probabilisitic safety assessment methods and do not have the attendant sunk costs for their development; this is different from the situation for power reactors. These variations in capabilities, resources, and interest must ,

be factored into any RI regulatory approach selected for a particular area of material use. I Thus, as part of the evaluation of attemative RI regulatory approaches, careful consideration must be given to: (1) the costs, both to the staff and licensees, of implementing a new approach; and (2) the benefits, in terms of risk reduction and/or elimination of unnecessary l

regulatory burdens. Consistent with these technical and programmatic considerations, the l series of implementation steps that are described in Attachment 4 for the proposed nuclear l materials framework include consideration of risk management issues.

The variability in target populations, standard-setting authorities, and existing dose limits (and thus in implied risk metrics and goals) is illustrated by the table in attachment 5.

Stakeholder involvement. Technical Surmrt. and Peer Review Implementation of the proposed framework and risk management approach will affect the O a biic.ota r aev -- at a aci < t iii i-). ao iic a . Acceroi# air.th t '<

considers that a broad range of input will be needed to effectively expand the use of RI regulatory approaches in the materials area. To assure appropriate consistency across NRC, important aspects of implementation will be coordinated with the PRA Steering Committee.

When changes to an existing regulatory approach are contemplated, the staff plans to minimize the impact on NRC and stakeholder resources by: (1) seeking stakeholder involvement through public workshops, Intemet postings, and pilot projects; (2) using technical consultants to supplement its own expertise; and (3) establishing a mechanism for technical peer review. For pee, review, the staff believes that a joint ACRS/ACNW subcommittee (with appropriate input from the Advisory Committee on the Medical Use of isotopes) could best integrate a knowledge of R1 approaches in the reactor area and an understanding of materials issues into its reviews.

The staff has discussed this matter with the Executive Director of the ACRS and the ACNW.

He agrees with the staff's recommended approach and with Commission appraw inuld form such a subcommittee.

RESOURCES:

To fully implement the approach described above, the staff in each NMSS pregam area would conduct most of the resource-intensive activities. These would include: evaluating the risk aspects of a programmatic area; interacting with stakeholders; making the appropriate changes to the regulations. staff review plans, and Regulatory Guides; training; and developing or adapting needed tools. This would entail an effort of 5 full-time equivalents (FTEs) per year for 5 years starting in FY 2000. In addition, a small cadre of material risk experts would be needed

' to facilitate the activities in various areas and assure an appropriate degree of consistency across NMSS and withia NRC. This would require an ad6tional 3 FTEs per year starting in FY

The Commissioners 10

'O 2000. In FY 2000, although no FTEs have been budgeted, $400,000 has been budgeted for contractor technical assistance which would provide approximately 2 FTEs of contractor support for the effort. If the Commission approves the staff's recommendations, the remaining unbudgeted 6 FTE would be reprogrammed from other, as yet, unidentified NMSS efforts in FY 2000.

Some support would also be needed from OGC and ACRS/ACNW. Estimated resources for these offices are 0.2 FTE and 0.5 FTE per year, respectively. Although the OGC and ACRS/ACNW budgets for FY 2000 did not include resources for this effort, these offices will reprogram resources from within their currently available budgets if the Commission approves the staff's reccmmendations. Resources to fully implement this effort in FY 2001 and beyond will be addressed during the FY 2001 budget formulation process.

RECOMMENDATION:

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That the Commission approve: (1) the staff's proposal to implement the framework set forth in Attachment 4 for using risk assessment in regulating nuclear material uses and disposal; (2) the !

staff's proposed approach for addressing risk management issues in those areas and, in particular, its development of risk metrics and goals; and (3) formation of a joint ACRS/ACNW subcommittee to provide technical peer review of the staff's future efforts.

COORDINATION:

O The Office of the General Counsel has reviewed this paper and has no legal objections. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has l

no objections. The interoffice senior level PRA Steering Committee was briefed on this paper i and its comments have been appropriately incorporated.

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Executive Director for Operations Attachments: 1. Task Group Members

2. Definition of Terms

3. Potential Regulatory Use of Risk Assessment Methods

4. A Framework for Applying Risk Assessment to Regulating Nuclear Material Uses and Disposal

5. Summary of Dose Limits and Target Populations

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Commissioners' completed vote sheets / comments should be provided directly to the Office of the Secretary by COB Friday, April 16, 1999.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT April 9, 1999, with an information copy to the Office of the Secret uy. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

DISTRIBUTION: i Commissioners OGC OCAA OIG OPA '

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-O TASK GROUP MEMBERS Office of Nuclear Material Safety and Safeauards:

Stephen Koenick, Division of Fuel Cycle Safety and Safeguards Dennis Serig/ John Telford, Division of Industrial and Medical Nuclear Safety Norman Eisenberg, Division of Waste Management Lawrence Kokajko, Spent Fuel Project Office l Seth Coplan (Chair), Division of Waste Management t Office of Nuclear Reaulatorv Research:

Nathan Siu, Division of Systems Technology Qtfice of Nuclear Reactor Reaulation:

Gareth Par:y, Division of Systems Safety and Analysis -

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DEFINITION OF TERMS Virtually all the safety assessment and compliance analysic tools used in the Office of Nuclear

~ Material Safety and Safeguards (NMSS) are a variety of systematic safety assessment methods. A subset of these systematic safety assessment methods are Probabil:stic Safety Assessment (PSA) methods. Because the terminology is not standardized and because each group of users of such methods tends to use terms to stress a particular aspect of the methodology or its application, a variety of terms have been developed and employed in various applications. The following definitions are provided for clarification:

System Analysis - System analysis is a directed process for the orderly and timely acquisition and investigation of specific system information pertinent to a given decision.- (Emia Tree Handbook.'1981)

Probabilistic Safety Assessment (PSA) - A wide class of probabilistic methods used to assess safety; this includes probabilistic risk assessment (PRA), risk assessment, failure mode and effects analysis, and performance assessment (PA).

Risk - The risk triplet is the set, <s, f,, x;>, in which si represents the ith scenario (sequence or progression); fi ls the associated frequency; and x,is the resulting consequence. (S. Kaplan and B. J. Garrick, "On the Quantitative Definition of Risk")

Risk Assessment (RA) " Risk Assessment refers to the technical assessment of the nature

.O and magnitude of risk." (from:" Risk Analysis: A guide to principles and methods for analyzing

. health and environmental risks." J.J. Cohrssen and V.T. Covello, CEO,1989)

Probabilistic Risk Assessment "Probabilistic Risk Assessment is an analytical technique for integrating diverse aspects of design and operatic 4) in order to assess the risk of a particular nuclear power plant [ facility] and to develop an information base for analyzing plant-specific

[ facility-specific) and generic issues. In achieving these objectives, probabilistic risk assessments serve many purposes." (from PRA Procedures Guide.1982.) Note, this is a definition of PRA focused on U.S. Nuclear Regulatory Commission (NRC) reactor activities and is used as a term of art, within NRC, to denote analyses of reactor safety, usually with considerable detail regarding the component and system failures that lead to an accident. In some cases the plant systems analysis (Level l PRA) is expanded to include an analysis of accident progression and source term (Level ll PRA) and further expanded to include  !

consequence analysis and risk integration (Level lli PRA) A broader community uses PRA to

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mean a broader variety of analyses devoted to other systems and with a wider range of complexity and detail.

Performance Assessment (PA) - PA, a type of systematic safety analysis, is a method: (1) to '

estimate the potential health, safety, and environmental effects of creating and using a nuclear waste facility; (2) to characterize these effects in terms of their magnitude and likelihood; (3) to i compare the characterization of these effects with acceptability standards; and (4) to present  ;

the results of these analyses in a format useful to reguiators, scientists, and the public.  !

(Adapted from N. A. Eisenberg, algt, "A proposed validation strategy for the U.S. DOE Office 4

of Civilian Radioactive Waste Management geologic repository program," GEOVAL 1987) PA, E

. ' as used programmatically in NMSS, includes any quantitative assessment or modeling -

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performed to evaluate a waste facility or part thereof, regardless of the degree to which the analysis is probabilistic..

Total System Performance Assessment (TSPA) " Performance assessment is a method of forecasting how a system or parts of a system designed to contain radioactive waste will behave over time. Its goalis to aid in determining whether the system can meet established performance requirements. A TSPA is the subset of performance assessment analyses in which all of the components of a system are linked into a single analysis. (U.S. Department of Energy (DOE), " Viability Assessment of a Repository at Yucca Mountain, Total System Performarce Assessment.' 1998) This is clearly a term of art used by DOE to emphasize the complete nature of the analysis. It should be noted that although a TSPA must calculate some measure of total system performance, it may also calculate (most analyses dg calculate) the performance of subsystems or provide intermediate results.

Integrated Safety Analysis (ISA)- An ISA is a systematic analysis to identify plant and extemal hazards and their potential for initiating accident sequences; the potential accident sequences and their likelihood and consequences; and the items (i.e., site, structures, systems, equipment, components, and activities of personnel) that are relied on for safety. This methodology, adapted from the chemical process industry, provides for flexibility in the scope

. and detail of the analysis, depending on the magnitude of the hazards and the nature of the system. This method has been used in NMSS to address the safety in fuel fabrication facilities and in spent fuel storage facilities.

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4 ASSOCIATION OF RISK ASSESSMENT METHODS WITH REGUI.ATED USES OF NUCLEAR MATERIALS Group Description Regulated Activities Risk Assessment Method .

l 1 Actness that irwolve long-term commitment of .-High level waste (HLW) Peik,...e-@ Assessment I a site or facility to the presence of nuclear disposal '

malenal at a phanned, acceptable level -Low level waste (LLW) deposal

-Decommescrung (residual  ;

contammateri)

-Mill tailings reclamaton 2 Actness that involve the use of engmeered -Transportaten Prhhehc Risk casks to isolate nuclear matenal under vanous -Dry cask storage Assessment or integrated normal and off-normal condsbons safety Analyses (ISA) 3 Actnees that involve chemical and physcal -Mining and milling of source ISA processmg of nuclear material at a largescale material facility -Uranium hexaflouride conversion

-Enrichment

-Fuel fabncaten

-Pre <:losure actnnes related to HLW and LLW desposal ' l t

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-Waste treatment facility j l (vitnficabon)

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O y 4 Actnees that involve the use of either sealed or unsealed byproduct matenal in industJist and madmalapplicabons

-irradiators

-Radography Hazard /Bamer Analysis (Nuclear Byproduct I

-Medmal Uses Material Risk Review

-Well Logging assessment methodo'ogy)

-Laboratory Use

-Manufactunng ano Distribubon

-Gauges

-measuring systems

-Waste Disposal (inemeration, packaging processing)

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POTENTIAL REGULATORY USE OF RISK ASSESSMENT METHOOS Group Achwity Regulatory Mandestabon of Risk Ucensee Use of Risk Staff Use of Risk insens Assessment m .mt 1 tegh.4evei messe (HLw) Pr *=s*~done standen coenedby Portormance esposal nde PA to demelop risk inngres (PA) to srtow comphance s)sapport of ndemalang and s

us#1seandard developmerit of godmos PA to sipport independere somew of hoonmoe's analyes 1

Low levet weses (LLW) Does standant. lor reasonable acenenos. PA to show comphanos with esposal coebed by rule PA to develop nok inngre; standard insipportof development of giadanos. PAtoeipport independers sowow of boennee's analyes P

1 , Demidial Does atendant, for reasonable scenanos, PA to show cornphance with

_) codeed by nee standard. Gisds.ioe will PA to dovutop nokinmgtes in sipport of downlopment permit sempirhed analyes in of giadanos. PAtosipport most camel independere nnmow of hooname's analyms 1 Mid talamps feelematon Urannan Miel Taihngs Retamon Control None None Act and - Erwironmental Protecton Agency standards esembheh an immidable bass 2 Transeortshen Portonnance4emed emeria and geannos Apphearnasconnee rney P N nek and nok.entonned reginatory deamore, perform nok - _ .; to le4.Teesan vessel)derhed from nok

_ (PRA)or support regidssory actus kesgrated Soloty Analyes irmeras (e.g Trosan reacnor vessel). OSA)to develop nek iraghes that unoorpn reguishons and giederse 2 Dy omsk saarmee Porturmanon tened crtiene aruf giadence Apphonnt4scenase rney and nak-informed regidssory doomore perform nok -

PanA orISAto dew nek

_ to inngres that underpm denied hem nok engtes oi.pport regisseory aceans. engidamons and gudenes 3 herung elsowas masonal Pomergeve cettene and gedance denved None ISAto detelop nok inngres tram ask esgres '

that unserpn regidamons andgiadence 3 Muhng of neuros massnal Premonstve onnens arms gedance dwived None BSA to dewstop nok magres tem eiskineWds sist inderpen regadebens and giadance 3 UF4 porwarwon Portormance _- - _ _ compneed of ISAsummary o ISA senmary forms the reenlotpcot connesiumnoes, ywon the demonstrale cunphence bones for regulatory hhekhood of eqwence unth portcumance ackwees-restissements 3 Enstohmore Perlosmance regwramares compneed of ISA senmary to ISA sonnery forms the resologmal consequences, yven the demonstrate comphece bees for mgidatory thekhoodof - unhpr _

anwees.

regiaremente 3 Puoilabncehort Portonnanos segissemores compneed of ISA summary Ic ISA summary forms the rN consequenons given the demonstrate comphance bears for regulatory hhalihoodof occurrence, unh pericwmance acerww retliaremeras.

3 Pse<lloonse antwees for >LW Dome standard for normal operatons and a ISA to show comphance with esposei ISA to sipport endeperusert apocenen of hiudy onenancs does standards rowawof anybeenmee analyses that may beer angrutcorey on post-closure r"pama-y performanos 3 Pie,ssewe menudy for U.W Does slendard for numal opershon ard None None empenal psomonphvo requwemeres Int all-nomial conetons

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w omemes imder pere memore.ar e. w w me ym me ynner.

Nennoesen) remotopaal conseguonoms, green the demoruirene comphence been for regdelary lihakheed of seawrence. vnth portormance seweet, requusmeras 4 Sealed Soweme Flegdelory req.emoras renyng korn Nons Ongomg vetnamert to esemphon to spoodc honnemg oniene develop nok Q that wuserinn regdekons, boonome and supschon preanoes, and gedence 4 Unoseled Snoodum Messnel Ro e edeneryre.oremerasranginghem Nore Ongomg ndnamers to mpeento apeune honnemo omone newesop nokinngres that walarpm regulebens.

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'2 O A FRAMEWORK FOR APPLYING RISK ASSESSMENTTO REGULATING NUCLEAR MATERIAL USES AND DISPOSAL

1. THE REACTOR FRAMEWORK OF SECY-95-280 e

As d3 scribed in SECY-95-280, the reactor framework is a general structure to ensure consistent and appropriate application of probabilistic risk assessment (PRA) methods. It has four parts. The first defines regulatory application areas (e.g., graded quality assurance) in which PRA can play a role in the U.S. Nuclear Regulatory Commission's (NRC's) decision-making process. The areas are grouped by the expected sophistmation of the PRA required (ranging from PRAs based on generic data to state-of-the-art PRAs using plant-specific data).

The second part entails an evaluation of the deterministic engineering considerations underlying the application area to ensure that the existing deterministic engineering approach is altered only after careful consideration. Factors to be considered include: defense-in-depth, the single-failure criterion, and appropriate codes and standards. The third part of the framework is an evaluation of risk issues in support of the proposed regulatory action.

Elements of this evaluation include: scope and level of detail of the PRA, human and equipment reliability, sensitivity and uncertainty analyses, and assurance of technical quality.

The final part integrates the deterministic and risk considerations to ensure a consistent and scrutable decision-making process and to ensure that the underlying bases for rules, regulations, regulatory guides, and staff review guidance are maintained or modified to the '

extent supported by the risk and engineering conclusions of parts two and three.

This framework is implemented through a six-step process. The first step is to identify the specife regulatory applications that are amenable to expanded use of PRA information and to identify responsible staff organizations and pilot plants. The second is to conduct pilot -

programs for selected regulatory application areas. These projects provide insight into the treatment of issues, the selection of risk metrics, and the development of standards and guidance. The third step of the implementation process is to develop and document the acceptance process and criteria. The fourth step is to make near-term regulatory decisions in response to industry requests and initiatives. The fifth is to develop formal PRA standards, working with appropriate professional societies and industry groups. Finally, the sixth step is to make long-term modifications to the regulations, if necessary.

2. RISK ASSESSMENT IN MATERIALS REGULATION-COMPARISON WITH REACTORS SECY-98-138 discussed the following differences between the nuclear materials and reactor pmgrams in terms of developing a framework for using risk-assessment in nuclear materials regulation:

1. PRA may be applicable only for a few nuclear material uses; other risk assessment methods may be needed for most such uses; i

2. Integrating probabilistic and deterministic considerations is not as important in regulating nuclear material uses as it is in reactor regulation; O

3 0 3. Relating analytical methods to specific applications is much more important for materials applications;

4. A broad range of licensee and regulator circumstances will need to be considered.

3; A FRAMEWORK FOR NUCLEAR MATERIAL USES AND DISPOSAL These differences are addressed by a framework that is quite similar tp the reactor framework of SECY-95-280. It too has four parts. Like the reactor framework, the first part defines regulatory application areas in which risk assessment methods can play a role in NRC's decision-making process. _The areas are grouped by regulated use (e.g., fuel fabrication) and within each use by regulatory application (e.g., graded quality assurance). The second part entails an evaluation of the current considerations underlying the application area to ensure that the existing approach is altered only after careful consideration. Factors to be considered include: deterministic considerations [ hazard, relative importance of human vs. equipment error, -

defense-in-depth (where applicable), codes and standards);, current risk considerations (e.g.,

use of performance assessment in geologic repository licensing); and institutional considerations (existing statutory requirements, Agreement State issues, and licensee circumstances). The third part of the framework is an evaluation of new risk considerations in support of the proposed regulatory action. Elements of this evaluation include: scope and level of detail of the risk assessment, sensituty and uncertainty analyses, and assurance of tec O co hnical quality.

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1. r final ce" part i t #tintegrates the current considerations and new risk >e r tie e cr#i di d c ie#-- ki a aroc e to #<-

that the underlying bases for rules, regulations, regulatory guides, and staff review guidance are maintained or modified to the extent supported by the conclusions of parts two and three.

This framework will be implemented through a five-step process. The first step is to identify the specific regulatory applications that are amenable to expanded use of risk assessment information and to identify responsible staff organizations. This step would be accomplished by identifying a full sat of regulatory application areas as defined above and then screening them to establish a set of applications that would be amenable to risk-informed (RI) regulatory approaches. The staff would intend to systematically evaluate all of its regulatory applications in this manner, but extemal considerations would be used to priontize which would be treated l first.. For example, the staff is currentiy working with an RI approach for total system j performance of a geologic repository for high-level radioactive waste (HLW) because of l extemal considerations regarding the national HLW program. Because of limited resources,  !

the staff is proposing this step-by-step approach, rather than a comprehensive reevaluation in all areas simultaneously. On this prioritized basis, the technical and programmatic factors  ;

affecting the choice of risk metrics ano goals in each regulatory application area would be '

systematically evaluated. Consideration would be given to: (1) the costs, both to the staff and

- licensees, of implementing a new approach; and (2) the benefits, in terms of risk reduction and/or elimination of unnecessary regulatory burdens. This evaluation would use predictive or  !

actuarial risk studies, as appropriate. Given these considerations, the staff would decide whether it seems appropriate to change the existing regulatory framework and, if so, propose risk metrics and goals as a basis for interaction with stakeholders. Such interaction would i nclude stakeholder workshops, intemet postings, and possibly pilot projects.

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~O The second step is to decide how to modify the current approach of the regulatory application areas that are determined to be amenable to RI approaches. Stakeholder workshops, intemet postmgs, and pilot projects will be used as an important source of information to address the following considerations: (1) what specific use is the staff expected to make of risk insights and risk assessment in development of regulations and guidance, licensing, inspechon, maammament, and enforcement? and (2) what specific use is the licensee expected to make of risk insights and risk maaaaament in planning and conducting its operations? The third step is to make the appropriate changes to the rules and regulations, staff review plans, and Regulatory Guides. Where feasible, the staff would encourage industry development of voluntary standards. The fourth step is staff training to assure consistent and knowledgeable implementation of the new R1 approaches, and the fifth step is to develop or adapt needed tools

. (e.g., risk assessment methods or computer codes). This five-step implementation process is shown in Figure 1.

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1 Step 1 Identify: (1) candidate regulator)  ;

applications for risk-informed approaches; and (2) responsible i oraanizations.

V Step 2 Decide how to modify current regulator 9 approaches.

Y Step 3 Change regulatory approaches.

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Y Step 4 Implement risk-informed approaches.

Y Step 5 Develop or adapt risk-informed tools.

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SUMMARY

OF DOSE LIMITS & TARGET POPULATIONS Dose om REGul.AToRY TAROrr PoPUI ATION REFERENCE Dose LeMrr Basis 500 REM ICRP & NCRP max tousvALENT pose To THE sxlN or AN OCCUPATIONAL NCRP # 116 RECOMMENDATION WORKERS roR EMEROENCY UrEWVING ErroRTs (P. 44) 400 REM NCRP CAREER MALE AsTRoNAuf WHoLE soOY NCRP #98 (P. 7)

RtcoMMENDATloN Dost EoulVALENT WMrr' 300 REM NCRP CAREER FEMALE AsTRoNAuf wMoLE soDY NCRP #98 (P. 7)

RtcoMMENDAtoN I Dose EouiVALENT UMIT' .

300 REM iO CFR I00 max TOTAL nAoiAviou pose rom A 2 Houn Pameoo To Twc 1 O CFR I 00. I I(A)(I)

Twynoso rnoM A PosTui.Avro riesion Paoouct mass.AsC Ir AN INoMouAL WERE PREsENT AT ANY Po0NT oF A NUCLEAR ntAcTom's Exclusion AmsA souwoAny 250 REM NCRP THEoRET) CAL oCCuPAttoNAL brEnME Dost ~ NCRP #98 (P. 7)

REcoMMENoAnoN i 00 REM NCRP WMoLE sooY pose roR urE-sAVING ACT1oNs NCRP #39' (P, 100)

RecoMMENDATloN (VAUD UNTIL l 986) 50 REM ICRP & NCRP max ErrscTivt pose To AN oCCuPATloMAL WORKER NCRP # 1 16 REcoMMENDAT1oN roR EMEROENCY UrE-SAVING EFroRTs ICRP 60 50 REM i 0 CFR 20 AamuAL onoAM om Tissus post oTwan THan ts.Ns or THE tyc; O CFR 20. I 20 I SnAu.ow pose rouev4LsNT to THz soum on ANY ExTmmurTr .

> 25 REM EPA PROTECTIVE VOLUNTARY WMoLE soDY Dose roR UrE-sAV0NO actions & EPA-400-R-92-OO l Action Gulots PROTECTION or LAMOE POPULATIONS (MAT f992) 25 REM IO CFR 100 max TOTAL mAotATloN oosE rom A 2 Hour PEntoo To NE WHoLE i 0 CFR I 00. I I(A)( I) sooy rnow A postutATuo riasson PnooucT msurAsc or Au tNoiviouAL WEnE PREsENT AT ANY PoeNT or A NUCLEAR nsActom's exclusion AmeA sovuoARY 25 REM EPA PROTECTIVE WMoLE sooY oosE roR urt-sAVING actions & EPA-400-R-92-OO I ACTloN Guiots & PROTECT 1oM or LAROE PopuLATloNs (MAY I 992);

USNRC RG 8.29 RG 8.29 (P. 8 3) 25 REM l O CFR 20 & DrETiME post uMrr ron eNoiviouALs PARTICIPATING (N I O CFR 20. I 206(EX2) 10 CT'R 835 PLANNED sPECIAL Exposures & I O CFR 835.204

' CAmerm WHoLE soof oose courvALENT uurT AT Aoc 55 sAsco ou A urimme exccas misn or cAncem MonTAuty or 3x 1 O* Pam RAo.

NCRP sitPont No. 39 (l 971) mas sten suPtastoEn av NCRP REPom7 No. I f 6 (l993)

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_ 3 DOst oR REGULATORY TARGET POPULATION REFERENCE DOst LIMrT BASIS ,

I 18.75 REM 29 CFR 19 8 0 max OUARTERLY DOSE FOR HANDS AND FOREARMS; FEET 29 CFR 19 8 0.96 (a)

! AND ANKLES (OSHA-REGULATED ACTIVITIES [

l 15 REM 1 O CFR 20 ANNUAL EYE DOSE EQUIVALENT (LENS OF THE EYE) f O CFR 20. I 20 t 10 REM USNRC RG 8.29 i ACUTE EMERGENCY EXPOSURE FOR PROTECTING RG 8.29 (1996) l VALUABLE PROPERTY (P. 8.29- 13) l 1 O REM NCRP ACUTE EMERGENCY EXPOSURE FOR UFE-SAVING ACTIONS NRCP # 9 i I RECOMMENDATION (P. 36) 7.5 REM 29 CFR 1910 max OUARTERLY DOSE TO SKIN OF WHOLE BODY OF 29 CFR 1910.96 (a)

OCCUPATIONAL WORKERS (OSHA-REOULATED ACTivtT1ES) 5 REM i O CFR 20 & ANNUAL EXPOSURE LsMrT FoR OCCUPATIONAL WORKERS 1 O CFR 20. I 201 &

6 O CFR 835 (NRC, DOE & STATES) i O CFR 835.202 MAX WHOLE SODY DOSE TO ANY INDIVIDUAL LOCATED ON OR 5 REM i 0 CFR 72 eEYOND THE NEAREST SOUNDARY OF THE CONTROLLED 1 O CFR 72.106 l AREA OF AN ISFSl OR MR5' I 5 REM l O CFR 35 NOTIFICATION LIMITS FOR MEDICAL MISADMINISTRATIONS 60 FR 48623 INVOLVING MEMBERS OF THE PUsuC (OCT 1995) 3 REM 29 CFR 9 I o max OUARTERLY DOSE TO THE WHOLE BODY 29 CFTt I 9 I O.96 (OSHA-REGULATED ACTivmES) l REMEDIAL ANNUAL ACTION LEVEL FOR NATURALLY NCRP # I 16 2 REM EPA OCCV.* MING RADIATION (RADON) FOR MEMBERS Or THE (P. 49)

PUBuC (CORRESPONDS TO 2 WLM*)

n .875 PEM OSHA max OI.,ARTERLY HAND OR FOREARM DOSE TO 29 CFR 1910.96(s)(3)

A MINOR (UNDER AOC I 8)

. IAEA THRESMOLD FOR CONDUCTING ENVIRONMENTAL MONITORING AND lAEA SAFETY SERtES #6 I .5 REM RECOMMENDATION ASSESSMENTS OF RADIATION EXPOSURE LEVELS IN WORM AREAS (i985) out To THE TRANSPORT OF RADIOACTIVE MATERIAL l .25 REM 49 CFR 172 max OUARTERLY EDE FOR OCCUPATIONAL RADIATION 49 CFR 172.803 EXPOSURE RESULTING FROM TRANSPORTATION ACTIVITIES (B)( l )

i REM -

Av0 A$moNAUT EXPOSURE PER FuGHT MISSloN NCRP #94 l

l OSHA-REOULATED ACTIVmES INCLUDE OCCUPATIONAL EXPOSURE FMOM FACILTAES OTHER THAN THOSE REOULATED BY NRC OR AN AOREEMENT STATE. TMESE MAT INCLUDE RADIATION EXPOSURES FROM X-RAYS OR LINFAR ACCELERATORS OPERATED SY NON-AOPEEMENT STATES.

ISFSI = INDE. PENDENT SPENT FUEL STORAGE INSTALLATION. MRS = MONITORED RETRIEVABLE STORAOC INSTALLATION l ONE WORKING LEVEL MONTH (WLM) IS APPRoxiMATELY EOUAL TO AN ANNUA.L EXPOSURE TO AN AVERAGE OF 4 PCI PER l

I UTER Or RADON IF THE RADON PRODUCTS ARE IN $O% EOULLIBRIUM WTTH THE RADON. ONE WLM EXPOSURE woULD RESULT FROM mEINO EXPol.ED TC 1 WORKINO LEVEL (WU FOR A PERIOD or 6 wCRK NO MONTM (i.E l 70 HRS)

P \miSK_MLT.wPD CJONES. NRC 05/t 5/97 REv 2 ATTACHMEl4T l

I

n-4 DOSE oR REGULATORY TARGET POPULATION REFERENCE DOSE LIMrr basis 1 REM EPA EPA PUSUC PROTECTION ACMON OUlDE UMIT FOR EPA 400-R-92-OO I EVACUATION & SHELTER (PP. 2-6) 750 MREM OSHA max OuARTERLv SxtN OF WHOLE BODY DOSE 29 CFR I 9 I O.96(S)(3)

TO A M6MOR (UNDER AGE I 8)

C50 MREM -

Av0 EDE' PER DiAONoSTIC NUCLEAR BRAIN SCAN NCRP #93 (P 46) 540 MREM - 10 CFR 20' AVO ANNUAL MEASURABLE DOSE PER RADIOGRAPHER NUREG 0713 (l993)* Vol. 15 (P. 4-6) 500 MREM IO CFR 35 PROPOSED PAMENT RELEASE CRrrERIA SECY-96-100 &

.- NUREG-I 492 500 MREM i O CFR 20 max DOSE COUIVALENT UMrr TO THE EMSRYO/ FETUS i O CFR 20. I 208, 10 CFR 835 & (ENTRE OESTATION PERIOD) i O CFR 835.206 &

49 CFR I 72 49 CFR I 72.803 (S)(3) 500 MREM ANSt, NoN* DESION CRITERIA FOR SHIELDINO FOR ANSI N433.1 &

AOREEMENT STATE MADIAMON-PRODUCING MACHtNES NCRP #49 REOS (f.E., TELETHERAPY, X-RAY MACHINES, IRRAD6ATORS) 500 MREM NCRP MAX ANNUAL EFFECTIVE DOSE UMT FOR INFREQUENT NCRP # f I 6 f RECOMMENDATION ANNUAL EXPOSUP.ES TO MEMSERS OF THE PUSUC (P. 46) 500 MREM NCRP REMEDIAL ANNUAL ActON UMf7 MECOMMENDED FOR NCRP #116 RECOMMENDATION CONTINUOUS EXPOSURES FROM NA1 URAL SOURCES (P. 50)

(EXCLLDING RADON) 500 MREM 49 CFR I 72 & max ANNUAL RADsAMON EXPOSURE TO MEMBERS or THE 49 CFR I 72.803 EPA FRC OENERAL PUBUC FROM TRANSPORTINO RADIOACTIVE ' (S)(2)

GUIDANCE' MATERIAL

• LAEA SAFETY SERIES #6 330 eeREM -

ANNUAL TEDE rom PUBuC NCRP#1O1 (INCLUDING ANNUAL MEDICAL EXPOSURE) (P. 73) 300 MREM -

ANNUAL TEDE FOR PUSuc NCRP #94 (EXCLUDING ANNUAL MEDICAL EXPOSURE)

EDE == ErFECvivE Dose souivALENT RESULTANT AVERAOE Dost FROM THE APPUCATION OF REGULATDRT REQUIREMENTS iN I O CFR PART 20 (s.E., ALARA)

NuMcER or RADoo0RAPHERs MoNf*ORED FOR RADIATION EXPOSURE IN 1993 WAs 47EO.

O' 8

EPA's FEDERAL RADIATION CouMCaL (FRC) OuiDaNCE wAs issuEc IN 1960. EPA is CURRCNTLY DEVELoPINO OUtDANCE FOR REOULATORY AGENCIES FOR UMrT)NO RADIATION exposures TO MEMBERS or THE OENERAL PUSUC, AND THE ANTICIPATED ANNUAL WMIT la EXPECTED TO sE I 00 MREM /rR. HourvtR, As or 1996, THis NEw EPA OUIDANCE DOCUMENT HAs NOT DEEN tasuCD.

IP:\Ris(MLT.wpD CsONEs, NRC 05/15/97 RCv 2 ATTACHMENT

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l-l LO DOSE oR REGULATORY ' TARGET POPULATION REFERENCE DOSE LIMrT basis 270 MREM lO CFTt20'* Av0 ANNUAL MEASURABLE OCCUPATIONAL DOSC PER l

I O CFR 20. I 201 WORKER AT LWR $ (1993)

200 MREM -

AVO ANNUAL DOSE TO MEMBERS OF THE PUBUC NCRP #93, # 1 Ie i

rRoM RADoM (P. 59; 45) l 160 MREM OSHA Av0 ANNUAL DOSE EOulVALENT TO NCRP #94 AIRPLANE CREW MEMSERS (P. 22) 125 MREM OSHA max OuARTERLY wwoLE soDY DOSE TO A MINOR 29 CFR I 9 i O.96(s)(3)

(UNDER AGE I 8) l I 00 MREM I O CFR 20 & MAX ANNUAL DOSE uMrTS roR MEMsERS or THE PusuC I0 CFR 20. I 301 &

IO CFR 835 I O CFR 835.208 l

t 00 MREM lAEA B.S.S.'" MAX ANNUAL DOSE EOurVALENT FOR NON-RAQsATION lAEA SAFETY SERIES WORKERS (& SHIELDING DESION SPECIFICATIONS) i15-1 100 MR/WK O CFR I 72 MAX WEEKLY RADIATION EXPOSURE TO MEMBERS OF THE 49 CFR 172.803 PusuC rROM TRANSpoRTAtloN or RADIOACTIVE MATERIAL (B)(2)

I 85 MREM PROPOSED MAX DOSE

• cam" TO AN INDIVIDUAL FOR RESTRICTED USE SECY-96 OS2 &

' 40 CFR I 96 (EPA'S PROPOSED DECoMMiSSloNING STD) PROPOSED 40 CFR 196. I I (D)(2)

( ) MAX ANNUAL DOSE EQUIVALENT TO THE THYRotD OF ANY 75 MREM l O CFR 72 REAL INDIVIDUAL LOCATED BEYOND THE CONTROM.ED AREA I O CFR 72.104 RESULTINO FROM RADIOACTIVE MATERIALS IN EFFLUENTS AND DIRECT RADIATION FROM AN ISFSI oR MRS 50 MREM i o CFR 20 ANNUAL TEOE TO MEMBERS OF THE PUBUC RESULTING PART 20 APP B. TDL 2 FROM THE INHALATION OR $ NOES 110N OF RADioNUCUDES CONTINUOUSLY FOR A YEAR 50 MREM 29 CFR I 91 O max TEOE FROM sNHALATioN OR INOESTION 29 CFR I 9 i O.96(C)(2)

TO A MINOR (UNDER AGE I 8) (REFS To 10 CFR 20)

' LsCENSEES (d.E.. FUEL CYCLE FACIUTIES) SUBJECT TO I O CFR 20. I 301(D) &

25 MREM i O CFR 20 EPA *S GENERALLY-APPUCABLE ENVIRONMENTAL RADIATION 40 CFR 190. I O STANDARDS IN 40 CFR I 90 25 MREM I O CFR 40, APP A MAX ANNUAL PUBUC DOSE EQUIVALENT CANNOT EXCEED 25 i O CFR PART 40, MREM wHoLE sODY 75 MREM THYRolD, AND 25 MREM To CRITERION 8 ANY OTHER ORGAN AS A RESULT OF EXPOSURE TO PLANNED OtSCHAROES OF MADICACTivE MATERIALS, RN-220 AND ITS DAUGHTERS EXCEPTED TO ENVIRONMENT.

RESULTANT AVERAot Dose IN l 993 FROM THE APPLeCATION OF REOULAToRY RCounREMENTS IN I O CFR PART 20 (s.E.,

ALARA)

" TcTAL MusasER oF COMMERCIAL LWR WORKERS MoNnoRED FoR RADIATION EXPOSURE 1993 WAS l 69.862. NUREG-IN 0713. VoL I 5 P.+0.

U 4AEA B.S.S.= INTERNATIONAL BAttC SAFETY STANDARDS FOR PROTECTION AGAINST IONIZIMO RADIATlON AND FOR THE SAFETY OF RADIATION SOUR:::ES SAFETY SER EF '4o. I i 5-1 (l 994).

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Dose oR REOULATORY TARGET POPULATION REFERENCE Dost LeMrr Basis 25 MREM l IO CFR 6I max OrFstrE RELEASES TO ANY MEMBER OF THE PUBUC iO CFR S I .4 i FOR BOTH OPERATIONS AND POST-CLOSURE ARE UMITED TO  ;

25 MREM wHOLE BODY, 75 MREM THYRotD, & 25 MREM l

OTHER ORGAN ,

I 25 MnEM 10 CFR 72 max ANNUAL DOSE EQUlVALENT TO THE WHOLE BODY OR I O CFR 72.104 OTHER ORGAN OF ANY REAL INDIVIDUAL LOCATED BEYOND THE CONTROLLED AREA RESULTING FROM RADICAC,TIVE MATERIALS IN EFFLUENTS AND DIRECT RADIATION FROM AN ISFSI om MRS 25 MREM 40 CFR 190 ANNUAL DOSE EQUIVALENT SHALL NOT EXCEED 25 MREM 40 CFR 190.10 wHoLE sODY, 75 MREM THYROID, & 25 MREM OTHER i ORGAN AS THE RESULT OF PLANNED DISCHARGES FROM URANIUM FUEL CYCLE OPERATIONS TO THE ENVIRONMENT.

25 MREM NCRP MAX ANNUAL EXPOSURE TO MEMSERS OF THE PUBUC FROM NCRP # 116  ;

RECOMMENDATION A SINGLE SOURCE OR SET OF SOURCES UNDER ONE (P. 47) l CONTROL 20 MREM -

MAX INDIVIDUAL PUBUC EXPOSURE DUE TO NCRP #92 TRANSPORTATION OF RADIOACTIVE MATERIAL (P. I65) 2C MRAD I O CFR PART 50 max ANNUAL BETA AIR DOSE FROM OASEQUS EFFLUENTS AT I O CFR 50, /PP I APPENDIX l ANY LOCATION NEAR OROUND LEVEL FR')M EACH LWR FOR SECTION ll (B. l .)

ANY INDIVIDUAL OCCUPYING AN UNRESTRICTED AREA l 5 MREM PROPOSED ANNUAL EDE FRoM ALL EXPOSURE PATHWAYS FROM A 40 CFR I 96. 61 40 CFR I 96 DECOMMISSIONING SffE I5 MREM MAX ANNUAL ORGAN DOSE OR DOSE COMMITMENT FROM l O CFR 50, APP I, t 0 CFR PART 50 RADIOACTIVE LODINE OR RAM IN PARTICULATE FORM FROM SECTioN 11 (C.)

APPENDlX l EFFLUE#dTS Rrr raaE FROM EACH LWR FOR ANY INDIVIDUAL OCCUPYING AN UNRESTRICTED AREA 1O MREM -

AVO ANNUAL EFFECTIVE DOSE EOUlVALENT TO INDIVIDUALS NCRP #93

1. N THE U.S. rROM CONSUMER PRODUCTS (P. 59)

IO MRAD 1 O CFR PART 50 MAX ANNUAL GAMMA AIR DOSE FROM GASEOUS EFFLUENTS I O CFR 50. APP I APPENDIX l AT ANY LOCATION NEAR OROUND LEVEL FROM EACH LWR SECTION ll (A)

FOR ANY INDIVIDUAL OCCUPYING AN UNRESTRICTED AREA 1O MREM EPA'S CLEAN AIR max DOSE UMIT TO MEMeERS OF *HE PUBUC FROM 40 CFR PAR

• 6 I ,

ACT RADIOACTIVE AIR EFFLUENTS RESULTING FROM FACIUTIES SUBPART l REGULATED UNDER THIS SUSPART I O MREM iO CFR PART 50 max ANN AL ORGAN DOSE OR DOSE COMMITMENT FROM I O CFR 50, APP l APPENDIX l UQUID EFFLUENTS FROM EACM LWR FOR ANY INDIVIDUAL IN SECTION 11 (A)

AN UNRESTRNN AREA

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(P:\misM,NLT.wpo csONE1. NRC 05/15/D7 nev 2 ATTACHMENT

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DOSE om REOuuToRY TARGET POPULATION REFERENCE DOSE Lawrr BASIS max ANNUAL DOSE TO ANY INTERNAL ORGAN OR NC TOTAL SODY' 40 CFR I 96.23 (1) 4 MREM PROPOSED CORRESPONDING TO sNDIVIDUAL MCLS SPECIFlED IN ($gg g 40 CFR I 96 i O CFR I 4 i FOR PRcnECnON OF OROUNDWATER AT A REMEDiATED SrrE 40 CFR I 4 I .16)

• 3 MREM iO CFTt PART 50 max ANNUAL TOTAL SODY DOSE OR DOSE COMMf7 MENT l O CFR 50, APP 1 APPENDIX l FROM LtOUID EFFLUENTS FROM EACH LWR FoR ANY SECTION 11 (A)

INDIVIDUAL IN AN UNRESTRICTED AREA 2 MREM IN IO CFR 20 MAX DOSE LJMIT TO MEMBERS oF THE PuSUC IN AN 1 O CFR 20. I 301 ANY ONE HR UNRESTRICTED AREA FROM EXTERNAL SOURCES" (A)(2)

MAX EXTERNAL RADIATION LEVEL FOR PACKAGES IN ANY 2 MR/HR 10 CFR 71 NORMALLY OCCUPIED SPACE (i.E., LOCATION OF DRIVER 10 CFR 71,47 (B)(4)

TRANSPORTINO RADICACTIVE MATERIAL) 2 MR/MR 49 CFR I 72 MAX RADIATION EXPOSURE TO MEMBERS OF THE OENERAL 49 CFR l 72.803 PUSUC FROM TRANSPORTATION OF RADIOACTIVE MATERIAL (S)(2)

MAX ANNUAL INDIVIDUAL DOSE EQUlVALENT PER SOURCE OR lAEA SAFETY SERIES 89; I MREM IAEA SAFETT PRACTICE wrTHIN THE MANOC OF MISKS TO SE CONSIDERED lAEA-TECDOC-855 &

SERIES "TRivlAL. " NCRP # 1 16 (P. 5)

ALSo CALLED "NEOUOlBLE INDIYlDUAL DOSE (NID)"

l

\

4 U I THE 4 MREM /rm oRoWNDWATER STANDARD 18 DERIVED FROM WE AVERAOE ANNUAL CONCENTRATION OF SETA PARTICLE AND PHOTON RAD OACmvlTY rRoM MAN-MADE RADIONUCUDES $N DRINKINO WATER WHICH WOULD PRODUCC AN ANNUAL DOSE COUlVALENT Or 4 MREM TO THE TOTAL SoDY oR ANY ONTERNAL ORGAN (3Eg 40 CFR 4 4 I . I 6). NBS HANDSOOK 69 (AuO l 963) IS USED

' AS THE BASIS FOR DERIVING THESC OUANTmES, AND EACH VARY FROM THE 4 MREM STANDARD (FOR EXAMPLE., THE MCL FOR SR-90 m- 0.07 MREM /rR: THE MCL FOR URANIUM = 0.7 l* REM /rm) 14 IN THE STATEMENTS OF CONS!DERATION FOR THE REVISED 1 O CFR PART 20 (Sgg 56 FR 23374). THE REASON STATED FOR THE INCLUSION OF THE DOSE RATE LIMIT OF 2 MREM $N ANY ONE HOUR WAS THAT THE LIMIT "PROVIDES A MORE READILY MEASURASLE QUANTITY THAN THE I 00 MREM /rR vALUE AND CAN SC MORE EASILY VERIFIED BY SHORTWRM MEASUREMENTS."

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-d REFERENCES AN?l N433.1, "SAFC DESIGN AND USE OF SELF CONTAINED, DRY SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY l), l977.

EPA-400-R-92-00 I , EPA PROTECTIVE ACTION GUIDES," l992, IAEA SAFETY SERIES No. 6, "REOULATIONS FOR THE SAFE TRANSPORT OF RADICACTlYE MATERIALS (l 985 EDmoN)

(11204,470BL lAEA SArETY SERIES NO. 37, "ADvtSORY MATERIAL FOR THE LAEA REOULATIONS FOR THE SAFV TRANSPORT OF RADIOACTIVE MATERWL ( l 98 5 EDmON) [1 A-470. I 1.

IAEA SArETY SERIES 1 15-1, *lNTERNATIONAL BASIC SAFETY STANDARDS FOR PROTECTION AGAINST lONIZINO RADIATION AND FOR THE SArETY oF RADIATION SOURCES " 1994.

REA TECDOC-855, " CLEARANCE LEvCLS roR RADioNuCUDES IN SOUD MATERIALS" (INTERIM REPORT FOR COMMENT), l998.

IAEA SAFETY SEmiES 89, " PRINCIPLES FOR THE ExEMP* TION OF RADIATION sources AND PRACTICES FROM REOULATORY CONTROL," l988.

ICRP PusuCADON 60, " ! 990 RECOMMENDATIONS OF THE ICRP."

NATIONAL BUREAU OF STANDARDS (NBQ HANDBOOK NO. 69,

• MAxlMUM PERMiSSleLE BODY SURDENS AND MAXIMUM PERMISSIBLE CONCENTRATIONS OF RADioNuCUDES IN AIR OR WATER FOR OCCuPAT oNAL EXPOSURE," 1969.

NCRP REPORT NO. 39, " BASIC RADIATION PROTECTION CRITERIA." l97l (SUPERSEDED BY NCRP REPORT 9 I).

NCRP REPORT NO. 49, " STRUCTURAL SMIELDING DESIGN AND EVALUATION FOR MEDICAL USE OF X RAYS AND GAMMA RAYS OF ENEROFES UP TO I O McV." l 976.

NCRP REPORT No. 9 i , "RECCMMENDATIONS ON UMITS FOR Exposure TO IONIItNO RADIATION," l 9 8 7.*

(SUPERSEDED sY NCRP REPORT No, I i 6).

NCRP REPORT #92, "PupuC RADIATION EXPOSURE FROM NUCLEAR power GENERATION IN 1hE U.S.." l 987.

NCRP REPORT No. 93, *lONfZlNO RADIATION EXPOSURE OF THE POPULATION OF THE U.S. " 1987.

RP REPORT NO. 94,

• EXPOSURE OF THE POPULATION OF THE U S. AND CANADA FROM NATURAL BACKOROUND RADIATION," l987.

CRP REPORT No 98, " GUIDANCE ON RADiAnON RECEIVED IN SPACE ACTivmES," l989.

NCRP REPORT No. I O 1, " EXPOSURE OF THE U.S. Population rRoM OCCUPATIONAL RADIATION " l989.

NCRP REPORT NO. I i 6, "l.JMITATION OF* EXPOSURE TO lONIZINO RADIATION," l 993.

NUREG-0713, VoL. I 5. " OCCUPATIONAL RADIAwON EXPOSURE AT COMMERCIAL NUCLEAR POWER REACTORS AND OTHER FACstmES, I993."

NUREG- 1492, "REOULATORf ANALYSIS ON CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADtOACTivt MATERIAL," l994.

U.S. NRC REOULATORY guide 8.29, "lNSTRuCT10N CONCERNING M"J FROM OCCUPATIONAL EXPOSURE," 1996.

IO CFR PART 20 (NRC REOULATIONS) 1 O CFR PART 35 (NRC REOuLATioNS) iO CFR PART 50 (NRC REOULATloNS) 1 O CFR PART 833 (DOE REOuLATloNS)

ED CFR PART I 9 i O (OSHA REOULATIONS) 40 CFR PART e n (EPA REOULATIONS) 40 CFR PART I 90 (EPA REOuLATIONS) 40 CFR PART I 96 (EPA REOULATIONS) 43 CFR PART l 72 (DOT REOULAtioMS)

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