Official Transcript of Proceedings

NUCLEAR REGULATORY COMMISSION

Title: Advisory Committee on Reactor Safeguards

Radiation Protection and Nuclear Materials

Docket Number: (n/a)

Location: Rockville, Maryland

Date: Tuesday, October 18, 2016

Work Order No.: NRC-2682 Pages 1-337

NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers

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NEAL R. GROSS

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1

1

2

3

4 DISCLAIMER

5

6

7 UNITED STATES NUCLEAR REGULATORY COMMISSION’S 

8 ADVISORY COMMITTEE ON REACTOR SAFEGUARDS

9

10

11 The contents of this transcript of the 

12 proceeding of the United States Nuclear Regulatory 

13 Commission Advisory Committee on Reactor Safeguards, 

14 as reported herein, is a record of the discussions 

15 recorded at the meeting. 

16

17 This transcript has not been reviewed, 

18 corrected, and edited, and it may contain 

19 inaccuracies. 

20

21

22

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UNITED STATES OF AMERICA

NUCLEAR REGULATORY COMMISSION

+ + + + +

ADVISORY COMMITTEE ON REACTOR SAFEGUARDS

(ACRS)

+ + + + +

RADIATION PROTECTION AND NUCLEAR MATERIALS 

SUBCOMMITTEE

+ + + + +

TUESDAY

OCTOBER 18, 2016

+ + + + +

ROCKVILLE, MARYLAND

+ + + + +

The Subcommittee met at the Nuclear 

Regulatory Commission, Two White Flint North, Room 

T2B1, 11545 Rockville Pike, at 12:59 p.m., Margaret 

Chu, Chair, presiding.

COMMITTEE MEMBERS:

MARGARET CHU, Chair

DENNIS C. BLEY, Member

CHARLES H. BROWN, JR. Member

WALTER L. KIRCHNER, Member

JOSE MARCH-LEUBA, Member
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JOY REMPE, Member

GORDON R. SKILLMAN, Member

JOHN W. STETKAR, Member

ACRS CONSULTANT:

JAMES CLARKE*

DESIGNATED FEDERAL OFFICIAL:

DEREK WIDMAYER

ALSO PRESENT:

HANS ARLT, NMSS

GARY COMFORT, NMSS

DAVID ESH, NMSS

JOHN GREAVES, Public Participant*

LISA LONDON, OGC

CHRIS McKENNEY, NMSS

ROGER SEITZ, Savannah River National Lab

JOHN TAPPERT, NMSS

DOUGLAS TONKAY, DOE

ANDREA D. VEIL, Executive Director, ACRS

PRIYA YADAV, NMSS*

*Present via telephone
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C O N T E N T S

Page

Opening Statements.................................4

Acknowledgment for Distinguished Service Award.....6

Introductory Remarks by John Tappert...............6

10 CFR Part 61 Final Revisions

Gary Comfort.................................8

David Esh...................................96

Comments on Final 10 CFR Part 61

Dr. James Clark............................189

Public Comment...................................196

Subcommittee Discussion..........................208

Adjourn..........................................238
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1 P R O C E E D I N G S

2 12:59 p.m.

3 CHAIR CHU: Good afternoon. The 

4 meeting will now come to order. This is a meeting 

5 of the Advisory Committee on Reactor Safeguards, 

6 Subcommittee on Radiation Protection and Nuclear 

7 Materials.

8 I'm Margaret Chu, Chairman of the 

9 Subcommittee. ACRS members in attendance are Joy 

10 Rempe, Charlie Brown, Jose March-Leuba, and John 

11 Stetkar, Dennis Bley, Dick Skillman, and Walt 

12 Kirchner.

13 Dr. James Clark from Vanderbilt 

14 University is participating in the meeting and 

15 joins us today by telephone. Dr. Clark will 

16 provide a summary of comments provided on previous 

17 versions of Part 61, submitted by the Consortium 

18 for Risk Evaluation with Stakeholder Participation.

19 We call it CRESP. Which is a research 

20 organization funded by the DOE. And then he will 

21 provide comments on the current version of the Part 

22 61 in the role as a consultant to the ACRS.

23 Derek Widmayer of the ACRS staff is the 

24 designated Federal Official for this meeting. Now 

25 the purpose of today's meeting is for the NRC staff 
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1 to discuss and propose the final 10 CFR Part 61, 

2 Low Level Radioactive Disposal.

3 The Subcommittee will gather 

4 information, analyze relevant issues and facts, and 

5 formulate proposed positions and actions as 

6 appropriate for further consideration by the full 

7 Committee.

8 Detailed proceedings for conduct of 

9 ACRS meetings was previously published in the 

10 Federal Register on October 1, 2014. The meeting 

11 is open to public attendance.

12 And we have received two requests for 

13 time to make oral statements. Time for these 

14 statements is provided on the Agenda after the 

15 presentation on this matter.

16 A transcript of today's meeting is 

17 being kept. Therefore, we request that meeting 

18 participants use the microphones located throughout 

19 the meeting room when addressing the Subcommittee. 

20 Participants should first identify themselves and 

21 speak with sufficient clarity and volume so they 

22 can be readily heard.

23 There's a telephone bridge line 

24 established for this meeting. So we request that 

25 participants on the bridge line please keep their 
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1 phone on mute to minimize interference with the 

2 audio reception on the meeting room.

3 At this time I ask that attendees in 

4 the room please silence all cell phones and other 

5 devices that will make noise to minimize 

6 distractions. And I remind speakers at the front 

7 table to turn on the microphone when speaking. And 

8 likewise to turn off the microphone when you're not 

9 speaking.

10 Before we being, I would like to take a 

11 moment to acknowledge one of our presenters today, 

12 Dr. David Esh from the office of Nuclear Material 

13 Safety and Safeguards, was the recipient of the 

14 2016 NRC Honorary Distinguished Service Award. 

15 Namely for his work in the area of performance 

16 assessment, which we'll hear later.

17 The Distinguished Service Award is the 

18 highest honor granted by the NRC to an individual 

19 based on outstanding achievement. Congratulations 

20 Dr. Ech. And we look forward to hearing from you 

21 today.

22 We will now proceed with the meeting. 

23 I call on John Tappert, Director of the Divisions 

24 of Decommissioning Uranium Recovery and Waste 

25 Programs of the Office of NMSS to make introductory 
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1 remarks.

2 MR. TAPPERT: Thank you, Chairman. 

3 Again, my name is John Tappert. I'm with the 

4 Office of Nuclear Material Safety and Safeguards.

5 The staff appreciates the opportunity 

6 to brief the Committee today on the draft final 

7 rule for Part 61. We've been on a bit of a 

8 journey. The routes of this Rule go as far back as 

9 2005 when the Commission directed the staff to look 

10 at the depleted uranium which was being introduced 

11 in the waste streams, and determine whether Part 61 

12 should be modified as a result.

13 In the intervening years, there have 

14 been a number of SECY papers, Commission briefings, 

15 briefings with the ACRS, briefings with the 

16 Compacts and then various other stakeholders. And 

17 the culmination of that work was the draft on the 

18 Rule which we just presented to the Commission 

19 recently.

20 So we look forward to the opportunity 

21 to share the results of our work and responds to 

22 your questions.

23 Today's presentation will be given by 

24 two of our senior staff, Gary Comfort, who is a 

25 Senior Project Manager in our Rule Making Group. 
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1 And has been responsible for shepherding it through 

2 the rule making process.

3 And Dr. David Esh, who you just spoke 

4 of, is with our Performance Assessment Group. And 

5 he'll be relaying more of the technical elements of 

6 the Rule.

7 So, without further ado, I'd like to 

8 turn it over to Gary.

9 MR. COMFORT: Well good afternoon 

10 everybody. As John indicated, my name is Gary 

11 Comfort. I'm in NMSS, in our Division of Material, 

12 Safety, State, Tribal and Rule Making Programs.

13 Today Dave and I are planning on 

14 providing an overview of our draft final Rule that 

15 we recently submitted to the Commission on -- that 

16 would update the low level radioactive waste 

17 disposal regulations in 10 CFR Part 61.

18 We last discussed this issued before 

19 the ACRS in 2013. So it's been a number of years 

20 since we've last seen you all. Go to the next 

21 slide.

22 During my portion of the presentation, 

23 I'm planning to summerize the activities that have 

24 occurred since we last met with you. And provide 

25 an overview of the changes that would result from 
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1 this draft final Rule being implemented.

2 But first I'm going to go over what the 

3 purpose of the Rule is. Why we're doing the Rule. 

4 And what Commission direction it was based on.

5 Also I'll go over a quick summary for 

6 you of the part interactions that we've had with 

7 ACRS and some of the comments that we've gotten out 

8 of ACRS. After that I'll provide an overview of 

9 the draft final Rule itself. What the major, you 

10 know, summary of the changes as well as get into a 

11 little bit of the specific Rule language.

12 Dave will then follow up with getting 

13 into the technical basis for some of that Rule 

14 language that we -- and Rule changes that we've 

15 done.

16 You know, and then after that I'll 

17 provide basically a summary of where we're going to 

18 go from here. What happens to the rest of the rule 

19 making processing? Just so you're familiar with 

20 it.

21 We welcome your questions and comments. 

22 And you know, we're looking forward to, you know, 

23 final draft letter -- or the final letter that goes 

24 to the Commission. And they'll use that in their 

25 review of the final Rule and they're, you know, 
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1 during the decision to approve or affirm it.

2 On the next slide, first I'd like to 

3 get into the purpose of what the Rule is really 

4 supposed to be doing and what it's intended to 

5 solve. The current 10 CFR Part 61 regulations were 

6 mostly developed in the early 1980s.

7 As such they focused in dealing with 

8 wastes that were currently being disposed of at 

9 that time period. Most of the evalu -- or the 

10 evaluations were based upon inventories that were 

11 being disposed of at the time.

12 In the following 30 years since that 

13 time, there's been a lot of other types of wastes 

14 that weren't initially envisioned at that -- or 

15 that weren't ongoing at that time that are now 

16 potentially being disposed of.

17 For example, in the 1980s uranium 

18 enrichment was exclusively operated by the 

19 Department of Energy and the Government. And the 

20 wastes were therefore disposed of. And it wasn't 

21 expected that large quantities of depleted uranium 

22 could be disposed of in a commercial low-level 

23 waste site.

24 Since then, we've basically gone into 

25 the idea of privitiz -- we've issued licenses for 
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1 privatized uranium enrichment facilities. And so 

2 therefore, the waste from those would be expected 

3 to go to a commercial waste site.

4 And when we did the original 1982 

5 revision of Part 61 as I indicated, this type of 

6 waste wasn't envisioned to the point that really it 

7 wasn't even addressed in that Rule, in the final 

8 Rule. And so therefore, it defaults into a Class A 

9 waste.

10 Another issue that came up since then 

11 is the idea of blending wastes. Where you 

12 basically would take higher classes of waste and 

13 combine it with larger quantities of lower class 

14 waste. And dispose of it as a low level classed 

15 waste.

16 So that's something else that came up 

17 upon, you know, during this rule making that we 

18 were looking at. The problem is that, you know, 

19 these blended wastes could result in quantities of 

20 waste near the top concentrations of the Class 

21 level then were originally evaluated as part of the 

22 original 10 CFR Part 61.

23 So, the purpose of this rule making is 

24 really to develop a strategy that would allow these 

25 different types of new waste and waste that occur 
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1 in the future that we don't know about now that 

2 would have a pathway for evaluation and potential 

3 disposal on low level waste sites. Next slide.

4 So, to resolve the problem -- these 

5 types of problems, the NRC staff decided to create 

6 an approach where the 10 CFR Part 61 regulations 

7 would instead focus and use a more performance and 

8 risk-based approach by requiring site specific 

9 analysis. Including for waste disposed of under 

10 the existing waste classification tables.

11 The site specific analysis will help to 

12 ensure that the waste streams that were not 

13 originally addressed in 1982, or that are disposed 

14 of in conditions or concentrations outside the 

15 original assumptions of the 1982 evaluations. That 

16 they're being safety disposed of.

17 Implementation of the new Rule is 

18 intended to reduce ambiguity and facility the 

19 disposal of these previously disposed -- previously 

20 unanalyzed wastes. In addition, some rule changes 

21 were made to better align 10 CFR Part 61 

22 regulations with updated existing health and safety 

23 methodologies.

24 MEMBER SKILLMAN: Gary, before you 

25 change, and would you back up to three, please? 
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1 You mentioned in your comments that there was 

2 depleted uranium prior to this rule making 

3 activity.

4 It was basically DOE and it was 

5 probably defense related. Is it the vision of this 

6 rule making to reach back to those waste locations 

7 also?

8 MR. COMFORT: Well, I mean, if they're 

9 under the Department of Energy, they have their own 

10 regulatory scheme. So this Rule would not directly 

11 affect those, no.

12 MEMBER SKILLMAN: So the answer is no.

13 MR. COMFORT: So the answer's no. Yes 

14 sir, right.

15 MEMBER SKILLMAN: Okay. Thank you.

16 MR. COMFORT: Okay now I'm going to 

17 briefly go over, you know, some of the direction 

18 that we've gotten. Because all of this rolls into 

19 why, you know, where the Rule came out to become on 

20 it.

21 So, first of all, starting with the 

22 Commission direction that we've gotten over the 

23 years. Which has changed a little bit. Or, you 

24 know, become updated by the Commission as you'll 

25 see.
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1 Subsequent -- I've got the wrong --

2 okay. So, basically we originally got the 

3 direction as John indicated, out of some 

4 proceedings that were ongoing with Louisiana Energy 

5 Services.

6 They basically took -- that took place 

7 in 2005 where the question arose as part of those 

8 proceedings about the classification of DU as a 

9 Class A low level waste. It kind of fell in 

10 default because it wasn't directly addressed in the 

11 Part 61 1982 Rule.

12 As a result of those proceedings, the 

13 Commission outside of the proceeding directed the 

14 staff to consider whether the potential quantities 

15 of DU, depleted uranium that were generated by 

16 commercial uranium enrichment facilities warranted 

17 amending the Waste Classification Tables. 

18 So, based on this direction, the staff 

19 performed a technical analysis to evaluate the 

20 impacts of near surface disposal of large 

21 quantities of DU. The staff submitted the results 

22 of the analysis to the Commission as part of SECY 

23 08-0147, which was response to Commission Order 

24 CLI-05-20, regarding depleted uranium, dated 

25 October 7, 2008.
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1 In response to this paper, the 

2 Commission directed the staff to -- in a Staff 

3 Requirements Memorandum, or an SRM, which was 

4 identified as SRM SECY 08-147 to begin a rule 

5 making to require site specific analysis for 

6 disposal of large quantifies of DU.

7 With this direction the staff then 

8 began a series of public meetings where we went out 

9 and tried to get some insight of what people 

10 thought were the major issues related to this.

11 And basically the other thing that the 

12 Commission said, is to develop supporting guidance 

13 and technical basis for this. As well as to 

14 maintain the waste classification of DU.

15 Now, since that point, the Commission 

16 has told us on the waste classification to revisit 

17 that subject after we complete this Rule.

18 MEMBER CORRADINI: Garry, what do you 

19 mean by maintain the waste classification?

20 MR. COMFORT: It's right now defaulted 

21 as Class A waste. So, they said, don't go in and 

22 change the waste classification.

23 MEMBER CORRADINI: And maintains means?

24 MR. COMFORT: Keep it the same right 

25 now.
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1 MEMBER CORRADINI: Okay. Thank you.

2 MR. COMFORT: Right. And that's what I 

3 was just saying. They have actually asked us after 

4 we've finished this project, to go back and re-look 

5 at the Waste Classification Tables, including DU in 

6 them.

7 And so we have a product due to the 

8 Commission eventually on that.

9 MEMBER BLEY: Could that have any 

10 substantial impact on what you've been doing for 

11 all these years to get ready for this Rule?

12 MR. COMFORT: Well, we had actually 

13 asked the Commission that a few years ago. I mean, 

14 you know, do we have --

15 MEMBER BLEY: Do we have separated for 

16 depleted uranium?

17 MR. COMFORT: Yes. Should we do a 

18 complete rule making, you know, now instead of this 

19 specific one. But they decided that because of the 

20 issue of DU that was going on at that time, that it 

21 was more eminent to go ahead and try to deal with 

22 that.

23 And we feel that actually the end 

24 result of the Rule itself creates a safety program 

25 that despite whatever the classification is, if 
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1 something is going to be disposed of in these low2 level waste sites, they will be shown that it's 

3 safe to dispose of it.

4 So, you know, in some ways the 

5 classification system other then it's a legal, you 

6 know, coming out of statutes, it would, you know, 

7 isn't as necessary.

8 MEMBER BLEY: Okay.

9 MR. COMFORT: So, revising it may not 

10 be considered as important or absolute. But it's 

11 something that we have a project to have to do, is 

12 to look at it.

13 Okay. Now so we underwent -- started 

14 doing the rule making. And while we were doing 

15 that and going out and just starting the regulatory 

16 basis for the rule making, the other issue came up 

17 of blended waste.

18 So, basically the Commission direct --

19 based on a then Chairman's direction, the staff 

20 developed an analysis of issues associated with 

21 blended wastes. And submitted that evaluation to 

22 the Commission in April 2010 as part of SECY 10-

23 0043, which is blending of low level radioactive 

24 waste.

25 In response to this paper, the 
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1 Commission directed the staff to incorporate the 

2 issue of blending into the ongoing DU rule making 

3 that we were doing. So, based on the updated 

4 direction, we updated the regulatory basis and 

5 continued working on the Rule.

6 And we went out and basically put out 

7 the regulatory basis for public comment as well as 

8 with some preliminary Rule language. While we were 

9 finishing up the proposed Rule package, the 

10 Commission instead came down with additional new 

11 direction in the form of the listed SRM up there.

12 That basically told the staff to allow 

13 flexibility for licensees to use recent ICRP dose 

14 methodologies in their site specific performances' 

15 assessment for the disposal of all radioactive 

16 waste. And to establish waste acceptance criteria 

17 based on a site specific technical analysis.

18 The Commission also directed the staff 

19 to use a two tiered approach that establishes a 

20 compliance period that covers the reasonable 

21 foreseeable future. And a longer period of 

22 performance that had no defined period or limits to 

23 evaluate the performance of a site over the longer 

24 time frames.

25 The period of performance was to be 
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1 developed based upon a candidate site 

2 characteristics such as waste package, waste forum 

3 disposal technology, cover technology and geo4 hydrology, and the peak dose to a designated 

5 receptor.

6 Finally, the Commission wanted the Rule 

7 to have compatibility requirements that would 

8 ensure alignment between the States and the Federal 

9 Government. So this basically readjusted where 

10 we're going with the Rule that we put out, or for 

11 preliminary rule writing.

12 CHAIR CHU: Gary, I'm not familiar with 

13 the blended waste. Can you elaborate on that?

14 MR. COMFORT: Okay. Blended waste, you 

15 know, again, if -- you have basically a Class A, B, 

16 C wastes and greater then Class C.

17 Basically the idea that was being 

18 envisi -- or looked at at that time is if you have 

19 large -- if you have small quantities of let's say 

20 a Class B waste, could you combine it and basically 

21 lower the classification by combining it with large 

22 quantities of Class A waste, and dispose of it as 

23 Class A waste?

24 So, that's where the blending comes of 

25 the two waste categories. And that's again where 
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1 the Commission's concern was that when we had 

2 originally done the Part 61 rule making, we had 

3 looked at, well, what is the average concentration 

4 going to be disposed of?

5 Now we're looking at a pathway that you 

6 could be much closer to the limits of the Class A 

7 waste -- or to the waste categories.

8 So, we got this direction from the 

9 Commission, and we redid the Rule, you know, and 

10 basically finally we got a proposed Rule to the 

11 Commission in 2013 for review and approval. And 

12 that was identified as SECY 13-0075.

13 This is actually the latest ruling 

14 which that the ACRS had been reviewing. And they 

15 provided comments while that paper was up with the 

16 Commission.

17 In that package, the staff had proposed 

18 a new and updated technical analysis using a two19 tier system, as was directed by the Commission. 

20 With a compliance period of ten thousand years, 

21 followed by a qualitative performance period.

22 It included a performance analysis --

23 or a performance assessment with a compliance 

24 period limit of 25 millirem per year. Which is 

25 basically what we were using.
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1 But, the current regulations didn't 

2 have a time frame associated with it. And it also 

3 included a new requirement for an inadvertent 

4 intruder assessment with a limit of five hundred 

5 millirem per year.

6 And just as aside, when I'm mentioning 

7 the term an inadvertent intruder assessment, or 

8 when I'm talking about intruders in general, I'm 

9 not talking about somebody who's purposely going 

10 onto the site to disrupt the waste. I'm talking 

11 about somebody who after the site's been closed, 

12 really isn't aware the site is there and starts 

13 doing normal activities and the impact around that.

14 So, in response to the SECY that we 

15 provided the Commission, the Commission directed 

16 publication of the proposed Rule. But, they 

17 identified a significant number of changes that 

18 they had the staff do before we put it out as a 

19 proposed Rule.

20 I'll get over -- onto those in the next 

21 slide. But one of the other items that they did, 

22 is they encouraged the ACRS to continue involvement 

23 in the rule making. And to -- and I should have 

24 shifted the slide to start. It's just skipping --

25 yes.
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1 MEMBER REMPE: Actually, before you 

2 leave that slide, did you want to finish the last 

3 bit?

4 MR. COMFORT: Yes. This is the one. 

5 Yes.

6 MEMBER REMPE: Okay.

7 MR. COMFORT: So, basically they

8 directed the staff to -- or encouraged the ACRS to 

9 provide independent review and recommendations on 

10 the Rule. And which is why we're here.

11 MEMBER REMPE: And I looked ahead. And 

12 you're planning now to publish the Rule. But then 

13 you're going to delay and publish the guidance 

14 after the Rule is published?

15 MR. COMFORT: No.

16 MEMBER REMPE: Is that the plan? 

17 Because I thought that was in one of your slides?

18 MR. COMFORT: No. The Rule and the 

19 publi -- the Rule is going to be published, or the 

20 plan is to publish it at the same time as the 

21 guidance is published. Or the guidance with the 

22 Rule and stuff.

23 If it's incorrectly stated in one of 

24 the slides, it's a mistake.

25 MEMBER REMPE: Okay. I didn't 
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1 understand the words. But I just wanted to make 

2 sure. So --

3 MR. COMFORT: Yes. No, the intent is 

4 that both documents will be published on the same 

5 day. And be, you know, be usable on those dates.

6 MEMBER REMPE: Okay. So, we just got, 

7 I guess, the guidance today?

8 MR. COMFORT: Right.

9 MEMBER REMPE: Okay. I just wanted to 

10 understand that.

11 MR. COMFORT: And the guidance isn't 

12 publically available at this point.

13 CHAIR CHU: Is that the usual way? The 

14 Rule and then the Reg Guide goes together?

15 MR. COMFORT: Yes. The Commission now 

16 has basically for all Rules they've intended that 

17 both when we issue proposed Rules, to have 

18 proposed, you know, draft guidance for review and 

19 comment. Because it helps you, of course, you 

20 know, understand what the intent of the Rule is.

21 CHAIR CHU: Got you.

22 MR. COMFORT: And how we plan on, you 

23 know, implementing it.

24 CHAIR CHU: Okay.

25 MR. COMFORT: And it's the same thing 
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1 with the final Rule. Okay. So --

2 MEMBER BLEY: And since that subject 

3 was brought up, glancing at the slides, I think 

4 David's going to talk about the guidance. And I 

5 suspect -- well, I hope when you do that, you've 

6 got your slides laid out to make it clear to us 

7 what's changed in the guidance as you go through.

8 Because we will not have read it by 

9 today of course. And we will, if we have time, 

10 have read it by the time of the full Committee 

11 meeting. So, we might have a lot more questions 

12 then, then we have now.

13 But, if you can -- the better you can 

14 point out what's changed, the more it will help us.

15 DR. ESH: Sure. I can try to do that. 

16 And it is a short document. So, it shouldn't take 

17 you long at all to --

18 MEMBER BLEY: It is? Okay. It wasn't 

19 so short before.

20 DR. ESH: It's pretty long.

21 (Laughter)

22 DR. ESH: So, it will be helpful -- it 

23 wasn't the 575 pages.

24 MEMBER BLEY: That was the before, 

25 right? Or is that the new one? They're the same. 
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1 Okay.

2 DR. ESH: But, it will be helpful to 

3 point out what areas changed and where the new 

4 material is compared to the old material.

5 MEMBER REMPE: So, just to clarify my 

6 confusion in the second presentation, we'll hear 

7 from you, it says, the final guidance document has 

8 been developed.

9 And it's in concurrence. And it will 

10 be issued after the Commission approves the final 

11 Rule publication.

12 So, your plan is to publish both the 

13 draft guidance and the Rule. Then the 

14 Commissioners will approve the Rule. And you'll 

15 make any changes to the guidance. And then you'll 

16 finalize that.

17 MR. COMFORT: Right. I mean, the 

18 guidance is --

19 MEMBER REMPE: Because I just didn't 

20 understand that.

21 MR. COMFORT: Yes. The guidance is 

22 substantially completely. But the Commission can 

23 and does occasionally make changes when they affirm 

24 the final Rule that we have to incorporate.

25 And we'd want to make consistent 
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1 changes so we're not finalizing the guidance at 

2 this point. And I'll get into that -- you know, 

3 where do we go from here at the end of the -- you 

4 know, after Dave's presentation and stuff.

5 But we'll get into some of that also.

6 MEMBER BROWN: But before you go on, I 

7 think there's a question for Gary. We got -- one 

8 of the copies you sent us was a red lined, strike 

9 out version of the Rule.

10 And it had the stuff -- is that the 

11 most current? Is that the --

12 MR. COMFORT: Yes. That -- what you 

13 received is a red lined, strike out versus the 

14 current Rule language. It incorporates --

15 MEMBER BROWN: Yes.

16 MR. COMFORT: What we sent to the 

17 Commission. So that is the --

18 MEMBER BROWN: So that is -- I mean, 

19 take out all the strike outs and you end up with 

20 what you intend to publish, --

21 MR. COMFORT: With what the final Rule 

22 --

23 MEMBER BROWN: Right?

24 MR. COMFORT: Yes.

25 MEMBER BROWN: Okay. So, that had it 
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1 in red. So it was pretty easy to --

2 MR. COMFORT: Right. It shows you 

3 where the significant change -- or where the 

4 changes were.

5 MEMBER BROWN: Okay. Yes. I wasn't 

6 that. I just wanted to make sure I was looking at 

7 the right thing.

8 MR. COMFORT: Yes. Because I'll be 

9 going over some of the major changes. But that 

10 document shows all the editorials and small things 

11 that I'm not going to be going over.

12 MEMBER BROWN: Okay.

13 MR. COMFORT: I'm not going to go over 

14 it word by word.

15 MEMBER BROWN: No. I'll pass those.

16 MR. COMFORT: Yes. I thought that 

17 would be laborious if I tried to do that.

18 Okay. So, as I said, the Commission 

19 provided us a lot of changes which is not usually 

20 normal without them asking to see it back before we 

21 publish the Rule. In this case they said, you 

22 know, make these changes and go do it.

23 Well, for example, this basically on 

24 the right side of the -- well, left side of the 

25 chart, shows what was in the Rule that we sent to 
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1 the Commission in SECY 13-075. And this is for the 

2 proposed Rule.

3 And this basically is a summary of the 

4 things that were in the published Rule. And the 

5 color changes show where areas that the Commission 

6 changed.

7 And so you'll see they're in some 

8 substantial areas of the change -- of the Rule. 

9 For example, --

10 CHAIR CHU: So, the right-hand side is 

11 the --

12 MR. COMFORT: Is what we actually 

13 propose -- or sent out, published it.

14 CHAIR CHU: The proposed final --

15 MR. COMFORT: Yes. The published 

16 proposed Rule. Not the -- yes, it's the -- not the 

17 final Rule. 

18 CHAIR CHU: It's not the final Rule.

19 MR. COMFORT: The final Rule, that's 

20 the next stage, yes. But this is what we proposed 

21 for public comment. So, this is what went out for 

22 public comment.

23 CHAIR CHU: Oh. For public comment.

24 MR. COMFORT: Right. So, this -- I 

25 want to get into this just because when we start 
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1 talking about the public comments, you need to know 

2 the time frame -- or I mean, get the frame of 

3 reference of what those comments were based on.

4 Because of course, we incorporated a 

5 lot of changes into the final Rule based on those 

6 comments. So, for example, on the analysis time 

7 frames, we've gone forward with a two-tier approach 

8 for time frames.

9 We've basically, as I had indicated 

10 before, a ten thousand year compliance period. 

11 Followed by a performance period.

12 The Commission instead directed us to 

13 go through and do a three-tier approach. With 

14 basically one thousand year compliance period 

15 versus a ten thousand. But they added in between 

16 this protective assurance period. Which was from 

17 one thousand to ten thousand years.

18 And for the performance assessments, we 

19 were to apply a five hundred millirem dose goal. 

20 It wasn't supposed to be a limit. But it's just 

21 basically do as reasonably achievable so you can 

22 get to that, you know, the minimized doses to get 

23 to that limit.

24 MEMBER BLEY: Did the Commission 

25 specify the thousand year?
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1 MR. COMFORT: They specified the 

2 thousand year in their document panel. And then it 

3 was followed by the performance period. Which was 

4 again, a qualitative type rule.

5 For the intruder assessment it was kind 

6 of -- they basically said, leave that similar to 

7 the same. That you're going to have a five hundred 

8 millirem limit for the first thousand years.

9 But then you have a five hundred 

10 millirem dose goal for the second -- for the 

11 thousand to ten thousand years. And then again, a 

12 qualitative review after that in the performance 

13 period.

14 The other thing that they did on the 

15 intruder assessment there was for the scenarios for 

16 it, because they were concerned about uncertainties 

17 which the Committee also sent its concerns about.

18 They directed us to make sure that the 

19 scenarios were based on activities that were 

20 ongoing at the time of closure of the site. And 

21 so, you know, rather then looking ten thousand 

22 years out in the future and trying to guess what 

23 was going on.

24 So, just base the assessments on what 

25 was current -- or what was going to be happening at 
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1 the closure of the site.

2 They also directed us to add some 

3 discussion of defense in depth analysis as well as 

4 an explicit description of safety case. So, those 

5 were new things. I mean, again, new concepts being 

6 added into the Rule, you know, after we'd sent it 

7 to the Commission.

8 And then the other major thing that 

9 they did was to basically direct us to change the 

10 Compatibility Category from a C to a B for the 

11 major provisions of the Rule.

12 Now a Compatibility Category is when 

13 the Agreement States who are actually regulating 

14 all of current licensees, they have to adopt 

15 regulations that are compatible with our 

16 regulations. And we assign a Compatibility 

17 Category with those.

18 So, for example, Compatibility Category 

19 B says that you have to make the regulations 

20 effectively the same. You know, use the same 

21 language to the greatest extent in all that stuff.

22 Compatibility C says you have to meet 

23 the effective goal of it. But you could be more 

24 conservative.

25 So, for example, you know, in this kind 
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1 of case, you know, we're saying a thousand year 

2 compabil -- or a compliance period, they'd have to 

3 meet under Compatibility B, they have to have a 

4 thousand year compliance period.

5 Under Compatibility C, they could have 

6 a thousand years, they could have longer then that, 

7 five thousand, ten thousand, whatever period they 

8 wanted. But the Commission had directed us because 

9 they wanted the consistency in the regulations to 

10 Compatibility B.

11 So, -- go ahead.

12 MEMBER BROWN: I just want to clari --

13 make sure you keep talking about intruder, 

14 inadvertent intruder. And you made a comment a 

15 minute ago that an inadvertent intruder is somebody 

16 who goes there after the site is closed, 

17 inadvertently don't know what's going on.

18 MR. COMFORT: Right.

19 MEMBER BROWN: When a site is closed, 

20 does it look like just a great green soccer field? 

21 I mean, is it a green field? There's no signs, no 

22 nothing?

23 I mean, in a --

24 MR. COMFORT: I'll let Dave answer 

25 that.
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1 DR. ESH: All right. So, when it's 

2 operating of course, there's physical barriers to 

3 somebody accessing the facility.

4 MEMBER BROWN: Of course.

5 DR. ESH: And then at the -- there's a 

6 five-year observation and maintenance period at the 

7 time of closure. That the idea is that the 

8 licensee will ensure that the changes they made to 

9 prepare the site for closure have not caused any 

10 negative affects to the potential of the -- the 

11 potential performance of the site after closure.

12 So then the institutional control 

13 period starts. And the institutional control 

14 period starts is still an actively maintained 

15 period where access to the site maybe prohibited by 

16 fences and signs and that sort of thing.

17 But the institutional control period is 

18 only allowed to be credited in the regulation of up 

19 to one hundred years after the point of closure. 

20 So, there will be some potential limitation of 

21 access to the site during the institutional control 

22 period.

23 But, after the institutional control 

24 period, there's no requirement to provide barriers 

25 to access of the site. So, if the engineered cover 
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1 was designed such that it looked like a green 

2 field, then yes, it would just look like a green 

3 field.

4 If it was like some of the engineered 

5 covers that are used for erosion protection control 

6 that have the large rick-rack designs, then it 

7 would look like a big mound of rocks essentially 

8 sitting on the surface.

9 So, it would depend on the design and 

10 the facility what it would look like at that point.

11 MEMBER BROWN: Well, if some 

12 development occurred, you could come in and there 

13 could be houses, there could be a mall, and --

14 DR. ESH: Right.

15 MEMBER BROWN: All that kind of stuff. 

16 Okay. That's -- I just wanted to understand. So, 

17 that's after the institutional period though.

18 DR. ESH: Right. Correct.

19 MEMBER BROWN: Okay. Thank you.

20 MR. COMFORT: And that's why again, 

21 they were saying, you know, look at what's going on 

22 at that time period, you know, when closure occurs 

23 as to what the ongoing activity is. So, if you've 

24 got housing near there, you know, assume it -- if 

25 there isn't, if it's a big, you know, desert kind 
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1 of thing, we're not going to make you assume that 

2 somewhere a thousand years from now that population 

3 will move in there at all.

4 You may consider some sorts of 

5 intrusions, but, you know, they said use realistic 

6 scenarios. Or that's what the regulations are 

7 requiring.

8 MEMBER SKILLMAN: Gary, let me ask 

9 this. As I looked at the Compatibility Categories, 

10 this is from the handbook, 5.9 part two.

11 MR. COMFORT: Right.

12 MEMBER SKILLMAN: It's certainly 

13 confusing to me how you can -- not you -- how this 

14 discussion can say, now it's a B and not a C when 

15 it almost appears Category A is the most 

16 applicable.

17 MR. COMFORT: Because of the health and 

18 safety --

19 MEMBER SKILLMAN: Yes.

20 MR. COMFORT: Right.

21 MEMBER SKILLMAN: So, what is the 

22 discussion that certifies?

23 MR. COMFORT: Yes. Because Category B 

24 is trans-boundary issues and stuff, and how you say 

25 these are trans-boundary issues. This is one of 
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1 those why, you know, I mean, partly why we looked 

2 at these. And This is an area where we got a lot 

3 of comments on and stuff.

4 And so I'll get into that. But we --

5 you know, most people agreed with you, how would --

6 does that occur? Why wouldn't it be A? Or why 

7 isn't C appropriate?

8 You know, for example on the compliance 

9 period evaluations, a lot of stakeholders were like 

10 well, my current State, you know, requires ten 

11 thousand years for the evaluation. You're 

12 basically saying limit that.

13 You know, it's going to make an unsafe 

14 -- a less safe review and all.

15 MEMBER SKILLMAN: Right.

16 MR. COMFORT: So, that's one of the 

17 things we considered when we did the final Rule. 

18 And we basically did go back and revert some of 

19 these major things from B. Or we recommending to 

20 the Commission that they be revered from what was 

21 designated as C -- or B, back to the C category.

22 So, the Agreement States can have their 

23 flexibility and, you know, maintain safety 

24 appropriately and all.

25 DR. ESH: And one thing I would add to 
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1 that as -- the Commission did give direction for 

2 compatibility B. But that's an area they 

3 specifically said to seek comment on.

4 Because I think they said we're going 

5 to make it B. But, let's see what our stakeholders 

6 think about it, was my interpretation of their 

7 direction.

8 MEMBER SKILLMAN: So, the conclusion 

9 is, it will be B. And while it's not universal 

10 consensus, there is acceptance of that category?

11 MR. COMFORT: Well, for publication of 

12 the proposed Rule it would be. In the final Rule 

13 we did change some of the major provisions back to 

14 C so that they have more flexibility as to, you 

15 know, they didn't have to meet it exactly. They 

16 could use longer time periods. Or use some 

17 alternatives.

18 MEMBER SKILLMAN: And you're going to 

19 discuss this a little more?

20 MR. COMFORT: Yes. I'll be getting 

21 into that. Just what about their comments --

22 MEMBER SKILLMAN: A little later. 

23 Thank you.

24 MR. COMFORT: Into the final Rule that 

25 we've done.
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1 MEMBER SKILLMAN: Thank you.

2 MR. COMFORT: Okay. So, that really 

3 brings us up to the publication of the proposed 

4 Rule. I'm going too just quickly step back to 

5 discuss the past ACRS interactions that we've had 

6 with you.

7 Just to remind you, the Committee and 

8 the new members, of what types of comments that 

9 we've gotten in the past on it. I'm not going to 

10 try to go over our feelings on some of them and 

11 all.

12 But, as you can see by the slide, we 

13 have had a number of interactions with you on Part 

14 61 in the past. They started in 2009. The last 

15 one as I said, was in 2013.

16 After most of them, I mean, we had two 

17 in 2011. One was on the Rule. One was on the 

18 guidance. We got a single letter.

19 But, after each of those we did get a 

20 letter from -- or the Commission got a letter from 

21 the ACRS. And we, you know, the staff responded to 

22 those letters.

23 On the next slide I go over some of the 

24 key issues so that you --

25 MEMBER BLEY: Not to bicker, but I'm 
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1 looking at what I have is our last letter was 

2 issued in February 2014. And we'd had a meeting in 

3 February, a full Committee meeting with you in 

4 February 2014.

5 MR. WIDMAYER: I can clarify that. 

6 They're identifying Subcommittee meetings that they 

7 were presenters at.

8 MEMBER BLEY: Oh.

9 MR. WIDMAYER: We've had meetings where 

10 they were not presenters.

11 MEMBER BLEY: Okay. But this was a full 

12 Committee meeting. 

13 MR. WIDMAYER: Yes. Our meeting was a 

14 full Committee meeting.

15 MEMBER BLEY: We wrote a letter in 

16 2013.

17 MR. WIDMAYER: Right.

18 MEMBER BLEY: We wrote another one in 

19 2014.

20 MR. WIDMAYER: They were three meetings 

21 that were just stakeholder involvement.

22 MEMBER BLEY: Okay. So that 2014 was 

23 just stakeholders?

24 MR. WIDMAYER: Yes.

25 MEMBER BLEY: That's the ones we've 
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1 had. Okay. I remember. Sam asked for those.

2 MR. WIDMAYER: Right.

3 MEMBER BLEY: Yes. Okay. Thank you.

4 MR. COMFORT: Thank you for bringing 

5 that up. So, going through the letters, I mean 

6 basically a lot of them had consistent issues from, 

7 you know, each letter.

8 I'm going to go over some of the 

9 general issues that I identified that you listed. 

10 First of all it said that you -- that the Committee 

11 had identified the Rule should be risk informed, 

12 based on site specific, realistic performance 

13 assessments with considerations for uncertainties.

14 The realistic assumptions for release 

15 in fate transport of view, using a realistic 

16 likelihood of intrusion, and a range of site 

17 specific conditions. I think actually, you know, 

18 when we got that the Commission did, as you saw in 

19 one of the slides, at their direction, they were 

20 telling us, you know, use realistic scenarios.

21 They did tell us to address 

22 uncertainties and things. So, they clearly adopted 

23 a lot of those recommendations.

24 Your Committee also suggested we use 

25 time frames determined on a case by case site 
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1 specific basis rather then defining specific fixed 

2 period performance and all. That's not something 

3 that the Commission went forth with.

4 They did define the periods of 

5 performance, you know, in the forms of the 

6 compliance period as well as the performance period 

7 with specified time frames and all. Next slide.

8 The ACRS recommended compliance with 

9 the performance objectives after institutional 

10 periods should be evaluated considering features, 

11 events, and processes, otherwise known as FEPs. 

12 Commensurate with the site specific risk.

13 The ACRS indicated their concerns with 

14 the value of requiring inadvertent intruder 

15 analysis because of the large uncertainties 

16 associated with human intrusion scenarios. And 

17 instead indicated that reliance on the durability 

18 and stability of the site was sufficient.

19 And finally, the letters stated that 

20 previously disposed waste should not be subject to 

21 the new requirements. You know, we've adopted some 

22 of these in some form, the Commission has. And 

23 others they went forth with, you know, with other 

24 approaches, you know, based on what the Commission 

25 had published in the proposed Rule.
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1 And although we appreciate all the 

2 recommendations put by the, you know, the ACRS as I 

3 said, you know, not all of the recommendations have 

4 been adopted. And we look forward to see what, you 

5 know, comments you do come out for the final Rule.

6 I think that will be important for the 

7 Commission to consider in making their 

8 determinations.

9 MEMBER BROWN: Can I ask to go 

10 backwards?

11 MR. COMFORT: Sure.

12 MEMBER BROWN: I guess one of my -- I 

13 was trying to -- I'm not sure I under -- no. Ahead 

14 again.

15 MR. COMFORT: Okay.

16 MEMBER BROWN: It's the bottom one. 

17 Did you -- let me read that. Should not be subject 

18 --

19 MR. COMFORT: Yes. Based --

20 MEMBER BROWN: You all did not -- you 

21 actually did require the sites to be -- the past,

22 previously posted, to do additional compliance. Is 

23 that correct?

24 MR. COMFORT: Correct. To the extent 

25 that they're -- if they're currently operating and 
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1 not completely terminated. So I mean, if it's a 

2 site that's completely terminated and closed down, 

3 we're not requiring.

4 But, if they're continuing to dispose 

5 of waste, then they would have to meet the new 

6 regulations and all.

7 MEMBER BROWN: For the new waste or the 

8 old waste?

9 MR. COMFORT: They'd have to do the 

10 performance assessment, which would have to include 

11 or address the old waste. But, there would not be 

12 an expected impact on it.

13 MEMBER BROWN: Okay. So, it's new 

14 requirements in fact.

15 MR. COMFORT: But there are -- yes.

16 MEMBER BROWN: Basically. Okay.

17 MR. COMFORT: And do you have anything 

18 to add, Dave, on that?

19 DR. ESH: And this was an area that we 

20 received a fair number of comments on. And the way 

21 I like to think about it is, you know, if you have 

22 a disposal facility that has some waste in it 

23 today, and then you have some unused capacity that 

24 you're going to put some more waste in in the 

25 future, the technical analysis that you do is going 
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1 to look at the impacts from all the wastes in terms 

2 of whether you're meeting the performance objective 

3 or not.

4 There's no -- all of it will contribute 

5 say to a ground water plume. And there's no way to 

6 separate the contribution, or should you separate 

7 the contribution from the waste that was put in 

8 previously to the new waste.

9 All of it contributes to a human health 

10 impact. So, if you want to continue to operate, 

11 you should include all the waste in your inventory 

12 in your assessment. In simple terms that's the 

13 description for this question.

14 CHAIR CHU: Even the old waste and the 

15 new waste are the same? You still --

16 DR. ESH: The old waste and the new 

17 waste maybe the same. It maybe different. It 

18 maybe similar isotopes. It maybe different 

19 isotopes.

20 If it was different isotopes, then it 

21 would be easier to separate it. But that's 

22 generally not the case is, you know, the waste 

23 that's in the older -- or the isotopes that are in 

24 the older waste are going to be similar to the 

25 isotopes that are in the new waste.
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1 So, from a health and safety 

2 standpoint, if you want to continue to operate, you 

3 should be meeting the performance objectives for 

4 all the waste that you have accumulated to date 

5 and that's the same idea that would apply even if 

6 you didn't change the regulations.

7 Whenever you get the closure, you want 

8 to be able to demonstrate that you're meeting the 

9 performance objectives for all the waste that 

10 you've taken to date. Not just oh, I'm going to 

11 separate out some section of the waste that because 

12 it was done under earlier requirements and then the 

13 new section of waste that I'm going to treat 

14 differently.

15 We didn't think that was a practical or 

16 a smart policy approach to deal with operation of 

17 these facilities. Now, a facility that's closed, 

18 these requirements are not applying to.

19 So, West Valley or Sheffield or some of 

20 the older legacy sites, these are not retroactively 

21 being applied to those older sites, these 

22 requirements.

23 MR. COMFORT: Okay. So, moving onto 

24 the next slide. I'm going to quickly go over.

25 We stopped, you know, originally on our 
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1 time line at submitting the proposed Rule and it 

2 being published. Now I'm going too just briefly 

3 update you from that point to the current date.

4 The proposed Rule was actually 

5 published in February 12, 2014. It was published 

6 for a 120-day comment period. On March 20 -- or 

7 actually, the SRM was provided on February 12, 

8 2014. And the proposed Rule was actually published 

9 on March 26, 2015 for 120 comment period.

10 Because of a number of stakeholder 

11 requests, we reopened the comment period from 

12 August 27 to September 21. And we received, you 

13 know, another few dozen comments on it.

14 We looked at those comments and we 

15 processed them as I'll discuss in a minute. And we 

16 finally, you know, developed a final Rule package 

17 that we submitted to the Commission on September 

18 15, 2016, SECY 16-0106.

19 So now I'm going to go over basically 

20 the comments that we received during the proposed 

21 Rule. Some of the major areas that we received 

22 comments on. So, next slide.

23 We did receive 24 hundred and one 

24 comment letters. Of which about 23 hundred were 

25 form letters. So, about one hundred discrete, you 
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1 know, comment letters.

2 We did extensive public outreach while 

3 the Rule was out there. We held six workshops and 

4 a webinar. And we did those workshops at, you 

5 know, we recorded them and basically analyzed the 

6 information coming out of them to develop any 

7 additional comments that weren't in part of the 

8 letters. And added them to our comment list.

9 As indicated, I have a number of the 

10 groups that we did get comments from and all. 

11 Overall we identified over eight hundred comments.

12 Which we then bend into groups 

13 together. And then responded to as part of the 

14 Statements of Consideration that's in the draft 

15 Rule package.

16 Next one. Some of the example -- next 

17 slide. Some of the examples of the public 

18 comments, one of the big areas was this whole idea 

19 of the time frames and how they're doing it.

20 The Commission as I said, had directed 

21 us to put in the proposed Rule the three tiered 

22 system. A lot of the comments were that it's much 

23 more complicated then necessary.

24 The comments, you know, felt that it 

25 was difficult to understand how to implement in 
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1 some ways and what we were wanting out of it.

2 Some of the stakeholders were concerned 

3 about this idea of the five hundred millirem dose 

4 goal. I mean, the current requirement in Part 61 

5 is a 25 millirem limit, annual limit for the 

6 performance assessment health for -- or for the 

7 public dose exposures.

8 But, you know, that -- there's no time 

9 frame associated with it. So, by putting clear 

10 time frames, you know, you may not have been going 

11 out that far anyway. 

12 So, were we really reducing health and 

13 safety? Not really. But to the perception of the 

14 public, that five hundred millirem limit was 

15 something that, you know, much higher then they 

16 expected and all.

17 So, the response to a lot of these 

18 comments, you know, the staff went back and 

19 revisited it. And we came up with a new system 

20 that we felt was simpler and based upon the public 

21 comments overall.

22 And, you know, we'll get into it in 

23 more detail. But, effectively it created back to a 

24 kind of a two-tier system. But, the first tier was 

25 more site specific based upon what types of waste 
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1 that you were going to dispose of.

2 So, effectively the compliance period 

3 would be a thousand years. Or if you're disposing 

4 of significant quantities of long-lived waste, then 

5 it would be ten thousand years.

6 And if you didn't have ten thousand 

7 year compliance period, you wouldn't even have to 

8 worry about the performance period at all. So, if 

9 you were just doing, you know, normal low-level 

10 waste that's short lived without the significant, 

11 you don't have to be -- you'll only be responsible 

12 for doing these performance assessments after a 

13 thousand years.

14 MEMBER BROWN: And this change is both 

15 in the rule and in the guidance?

16 MR. COMFORT: This -- yes. Everything 

17 that we've made in the rule will be reflected in 

18 the guidance that you have, in the draft guidance 

19 that we've developed.

20 And things such as, like I use the word 

21 significant quantities of long-lived waste, that's 

22 discussed in the guidance. And Dave will get into 

23 that a little bit more.

24 Any other questions? Another area as 

25 we discussed earlier was the Compatibility 
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1 Categories. You know, a lot of the stakeholders 

2 felt that it reduced current health and safety 

3 because some of the States had longer compliance 

4 periods where they had the limits of 25 millirem 

5 after, you know, after ten thousand years.

6 Or some States even went further to 50 

7 thousand. Or peaked theirs that they evaluated or 

8 required the evaluations.

9 Most of the commentors recommended C. 

10 A few liked the idea of having, you know, a comment 

11 basis across all the waste sites. But again, you 

12 know, there are -- in different areas and how, you 

13 know, in each State should be, you know we felt 

14 should be allowed if they want to put a little bit 

15 more restrictive or do it.

16 And also, we didn't want to disrupt the 

17 current programs significantly of what they were 

18 going. So in that case we, you know, in order to 

19 help adapt that, we changed in the final Rule the 

20 compliance period definition to a Compatibility C.

21 That's where the time frames are, are 

22 the thousand year time frame, or ten thousand year 

23 time frame was. So they can use longer.

24 Some of the areas remained C, such as 

25 the performance period review. We had a, you know, 
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1 had in the proposed Rule and stays as C.

2 The other big area though that we 

3 changed from B to C was in 61.58, which is the 

4 waste acceptance criteria. So, we were allowing 

5 more flexibility on the States of what they 

6 required for that.

7 I'll go up, continue on with some of 

8 the comments. Again, we were talking about a few 

9 minutes ago about the grand fathering and all. We 

10 got a lot of comments on that.

11 A certain number of the comments were 

12 hey, 61, you know, 10 CFR 61.1.a kind of seems to 

13 have a grandfather clause in there. That it says 

14 effectively that, you know, States can adopt these 

15 on a site by -- or a case by case basis. You know, 

16 the regulations on a case by case basis.

17 Well, the intent of that was when we 

18 published the original Part 61, that there wasn't a 

19 frame work at that time other then Part 20 for 

20 doing these rules. So, we were creating a whole 

21 new frame work.

22 And so the idea was, it may be harder 

23 for some of these States to adopt these 

24 requirements immediately. And so we put that 

25 language in there.
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1 So, it's kind of an artifact. But they 

2 were saying hey, it's still in there. Well, 

3 clearly it wasn't intended to apply to this type.

4 So, we basically have gone through and 

5 addressed the comments on grand fathering that we 

6 do, as Dave said, think that it's important to 

7 include sites that are currently operating under 

8 this new requirement.

9 And as well to make sure there's no 

10 future concern, we have removed that clause from 

11 61.1.a so that, you know, people won't go back and 

12 say hey, you know, the States don't have to adopt 

13 that because of that language.

14 That was really as I said, an artifact 

15 from the original Rule. And should have had a time 

16 frame that it was based on and removed previous to 

17 this.

18 Another interesting --

19 CHAIR CHU: Gary, can I ask a quick 

20 question?

21 MR. COMFORT: Yes.

22 CHAIR CHU: How often do licensee, 

23 operating licensees have to renew their license? 

24 Every how many years? Or do they differ from State 

25 to State? Or what?
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1 MR. COMFORT: It's dif -- my 

2 understanding is it's different from State to 

3 State. But they may have more information on that. 

4 Okay.

5 CHAIR CHU: Okay.

6 MR. COMFORT: Yes Because as part of 

7 the regulatory analysis, I'm pretty sure that I saw 

8 some States that were evaluating. Because we tried 

9 to do it based upon what their actual renewal 

10 cycles would be.

11 And I think it varied, you know, some 

12 maybe like ten years. Some maybe 20 years on what 

13 it is. But, it depends upon the State and what 

14 they've required.

15 Another bit area that we had that was 

16 interesting was backfit. A lot of NRC's 

17 requirement, or regulations basically require us to 

18 do a backfit evaluation when we're changing the 

19 regulations.

20 Part 61 does not have that kind of a 

21 requirement in it. I mean, we do look at, you 

22 know, that we do through the regulatory analysis 

23 that I just mentioned, some cost benefit analysis 

24 on it. But we don't do a formal backfit.

25 The comments that we received were 
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1 well, basically this is going to impact, you know, 

2 a Part 70 licensee doing uranium enrichment. They 

3 do have a backfit provision. So why doesn't 

4 backfit apply because of that?

5 And basically we went through our 

6 review and determined that, you know, and normally 

7 unless the Commission directs otherwise, we don't 

8 do backfit for areas where, you know, there's kind 

9 of the subsequential impact to somebody. So, you 

10 know, this impact is directly to the regulations 

11 for low-level waste disposal.

12 And it just happens that somebody 

13 disposing of their maybe impacted, but we don't 

14 look at that as part of, you know, being under the 

15 backfit of the Part 70 provision, or having to be 

16 reviewed under that. Because we're not changing 

17 Part 70 on it.

18 So, as a result, we have not included 

19 backfit. We feel satisfied the regulatory 

20 analysis, which we did do a lot of update to trying 

21 to -- we've talked to a lot of the licensees in 

22 States to get better estimates of the costs.

23 And the costs have showed to be a, you 

24 know, potentially a lot higher then what was in the 

25 proposed Rule in the final regulatory analysis. 
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1 Which is publically available as part of the 

2 package.

3 So those are some of the major areas of 

4 where we had, you know, comments in. I mean, we've 

5 got a lot of other comments that some were great 

6 editorials where, you know, use consistent rule 

7 language.

8 There were other comments, you know, 

9 that were identifying, you know, problems that we 

10 had that we clarified. You know, such as you 

11 referenced one part you've changed. But you didn't 

12 fix it in the other part in Part 61.

13 So, we really appreciated all the 

14 comments. And as I said, we have an extensive 

15 write up as a response to all the comments that we 

16 did identify.

17 So now I'm going to go over to what the 

18 meat of what we're really here for, is to look at 

19 the draft final Rule changes that we've done. 

20 Basically this chart, or table, indicates the 

21 changes from the current Part 61.

22 We're going to forget about the 

23 proposed rule and previous iterations that we had. 

24 I'm going to go now just talk about changes that 

25 are from the existing Part 61. That's what I 
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1 provided you, you know, the Committee with the red 

2 lined, strike out version of.

3 So, first thing is that was that we're 

4 requiring a site specific analysis. That's not in 

5 the current Rule.

6 And then we're going into these --

7 we're specifying time frames for the technical 

8 analysis. And I'll go into a little bit more 

9 detail in a couple of minutes of where these 

10 changes are in the Rule, and detail what they are.

11 But, for this one we're basically 

12 putting the time frames as I said, for a compliance 

13 period of a thousand year or ten thousand year, 

14 depending upon how much long-live radionuclides are 

15 being disposed of at the site.

16 MEMBER SKILLMAN: Gary, let me ask this 

17 please. Is there any other points in government 

18 where a one thousand year or ten thousand year 

19 analysis horizon is utilized? Is there any other 

20 place?

21 MR. COMFORT: You mean the combination 

22 of one or the other?

23 MEMBER SKILLMAN: Of either?

24 MR. COMFORT: Oh, yes. Dave can go 

25 over that.
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1 MEMBER SKILLMAN: I mean we're in 

2 2016. 3016 sounds like a long way away.

3 DR. ESH: Right. So, the thousand 

4 years is used in NRC's decommissioning under 10 CFR 

5 Part 20. We have a thousand year period to do an 

6 assessment for unrestricted or restricted release 

7 in decommissioning.

8 For the disposal of high level waste, 

9 the analysis time frame goes out to a million 

10 years. Broken into two phases up to ten thousand 

11 years. And then from ten thousand years to a 

12 million years.

13 So, that requires a million year 

14 analysis. For the waste isolation pilot plant, I 

15 believe they do ten thousand year analysis there 

16 for analysis of the disposal of transuranic waste 

17 at WIPP.

18 Internationally, there's a whole 

19 variety of time frames that are considered. And 

20 generally when you speak to the international 

21 people, they're somewhat taken aback by the U.S.'s 

22 position that we would look at significant 

23 quantities of long-lived waste for a thousand 

24 years, if that's what we were proposing.

25 They generally are much more 
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1 comfortable looking at longer time frames. So, 

2 they either look at longer time frames, or they 

3 first put a limit on the amount of long-lived 

4 wasted that's suitable for near surface disposal.

5 And the IAEA pretty much does this too. 

6 Although the IAEA generally gives higher level 

7 guidance to how to solve a problem. They don't 

8 say, you know, use this number and that number for 

9 the time frame and the concentration.

10 But, their framework is pretty good. 

11 So they have, I would say, a better framework in 

12 terms of waste classification then we do. And so 

13 do some of the other countries like France for 

14 instance.

15 So, in the U.S. we mix long and short16 lived waste together in our waste classification 

17 system. And some other programs they distinguish 

18 the type of waste not just based on the 

19 concentrations of the current day, you know, 

20 radiation hazard from handling the material.

21 But also in terms of the longevity of 

22 the waste they make distinctions. And so, for 

23 instance in France, their long-lived waste once you 

24 get to a certain threshold, is all destined for a 

25 geologic or a deep disposal system. They don't put 
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1 any of that in the near surface.

2 Whereas, in the U.S., what we're taking 

3 about here, partly because of our classification 

4 system is, in some circumstances like with the 

5 large quantities of depleted uranium, you're 

6 putting significant quantities of long-lived waste 

7 in the near surface.

8 So, that distinction needs to be made. 

9 I went kind of off on a tangent in the 

10 international space and answered your question.

11 MEMBER SKILLMAN: That was very 

12 helpful. And I appreciate that.

13 DR. ESH: Right. So, but in the 

14 domestic side, there are instances where the time 

15 frames are developed. And I'm going to talk about 

16 that in more detail whenever we get there.

17 MEMBER SKILLMAN: Thank you. That was 

18 very helpful. Thank you.

19 MR. COMFORT: And so the key point about 

20 the thousand or ten thousand years, currently in 

21 our current regulations there aren't any time 

22 frames at all. So, it does lead to some ambiguity 

23 as to how long do you need to analyze that for.

24 It says you've got to protect the 

25 members of the public, you know, and maintain a 
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1 dose of 25 millirem. Some people could say, you 

2 know, hey that's out for whatever the peak dose or 

3 long time. Others are, you know, hey, we're really 

4 in general talking about short-lived waste. So 

5 we're only going to analyze that to five hundred 

6 years.

7 But, that's what we're trying to do, is 

8 create a system that reduces that ambiguity by 

9 providing time frames for these analysis.

10 The other thing this has that we do, is 

11 we're adding a new requirement for technical 

12 analysis for protection of the inadvertent 

13 intruder. That's, you know, not -- there are --

14 there is a requirement to protect them.

15 But it doesn't have a dose limit 

16 associated with it. As part of this new 

17 requirement, you'll have a five hundred millirem 

18 annual dose limit that you have associated with.

19 Now one of the changes that we've done 

20 from what the Commission directed based on public 

21 comment is the same ideas. Doing scenarios out 

22 into the future and guessing what's going to happen 

23 at the site is difficult.

24 So, even closure, if you've got a new 

25 site, that could be 50, a hundred years away from 
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1 now. Trying to guess what's going to happen in a 

2 hundred years could be significant.

3 Instead what we've change, or what 

4 we're recommending in the Rule language to change 

5 to is to basically say, do the analysis of what's 

6 going on at the site at the time the analysis is 

7 done. You know what that is. There's not a lot of 

8 question about what's going on. So, it's easier to 

9 analyze.

10 But, you'll have to update those 

11 analyses during renewal. And then we'll have a 

12 final requirement to update them at closure. So 

13 again, you're getting an effective goal of the 

14 analysis will be based on closure when the site 

15 closes.

16 MEMBER BLEY: When does renewal come 

17 up?

18 MR. COMFORT: Renewal is based upon 

19 whenever, you know, whenever the requirement for 

20 the Agreement State is. I mean, what period 

21 they've selected at what point.

22 MEMBER BLEY: And that's different for 

23 every?

24 MR. COMFORT: It's my understanding 

25 it's different for each site. Or each State I 
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1 should say.

2 MEMBER BLEY: Well, okay.

3 MR. COMFORT: We've also added this new 

4 ten thousand year performance period analyses. 

5 Now, it's intended to be more of a qualitative 

6 analysis. It can be based on technical analysis 

7 itself.

8 But we're not putting any type of 

9 specific limit, you know, that you have to meet 

10 during that post time frame. It's more for the 

11 regulator to be able to make a decision 

12 particularly for these long-lived radionuclides.

13 You know, that there will be some form 

14 of public health and safety going on in that 

15 future. But it's difficult to tell what's going to 

16 happen, you know, a thousand years, let alone ten 

17 thousand or 50 thousand years out there.

18 MEMBER BLEY: Question. You're using a 

19 thousand and ten thousand because that's what the 

20 SRM said. Is that right?

21 MR. COMFORT: Well yes. The original 

22 proposed Rule for the SRM. But also, I mean, it's 

23 members of the staff had provided in the original 

24 proposed Rule, we used ten thousand years.

25 But the Commission's divided it into 
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1 the one thousand and ten thousand years.

2 MEMBER BLEY: Okay.

3 MR. COMFORT: So, we're trying to be 

4 more site specific by allowing, you know, instead 

5 of just one flat for all waste that there are 

6 differences in what types of wastes some sites may 

7 want to accept.

8 MEMBER BLEY: Take me back. Because I 

9 don't remember. Is there -- is anywhere the 

10 rationale laid out in the Rule and the SRM or 

11 somewhere else about where ten thousand years comes 

12 from?

13 Why is it ten thousand years? This is 

14 bothering me. I don't understand that at all.

15 DR. ESH: As opposed to seven thousand 

16 or --

17 MEMBER BLEY: Anything else.

18 DR. ESH: Twenty-three thousand, or 

19 something else right?

20 MEMBER BLEY: Or just a thousand. I 

21 mean, here's what I remember.

22 DR. ESH: Okay.

23 MEMBER BLEY: What I remember is what 

24 the Rule says is if the peak comes after a thousand 

25 years, then you use a ten thousand year. And 
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1 there's one other case where, and I forget what 

2 that is -- oh, if the daughters continued to grow 

3 after a thousand years, you use ten thousand.

4 The one I know we're concerned about is 

5 depleted uranium. It doesn't peak at ten thousand 

6 years. It peaks way out by forever. So, ten 

7 thousand years isn't much different from a thousand 

8 years.

9 I don't have a clue why we come up with 

10 this second number. And why it's what it is. And 

11 I don't remember reading a justification that 

12 convinced me in any way.

13 DR. ESH: Well, we did a white paper on 

14 considerations for selecting the analysis time 

15 frame. And if you don't have that, we should get 

16 you that. And I'll put an action item for that.

17 MEMBER BLEY: This was back in '13 or 

18 something.

19 DR. ESH: I believe it may have been 

20 generated in about 2011 or so.

21 MEMBER BLEY: Okay.

22 DR. ESH: Somewhere in that time frame.

23 MEMBER BLEY: But my memory of it was, 

24 it just said because DU keeps growing, we're going 

25 to use a later time period. But ten thousand 
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1 doesn't get you anywhere near where the peak 

2 occurs.

3 DR. ESH: Right. Well, the situation 

4 with depleted uranium is a little unique in that 

5 depleted uranium is essentially free of its 

6 daughter products whenever it's generated. So, 

7 it's a very pure material.

8 And then those daughter products build 

9 in over time. And -- but the uranium can cause 

10 health impacts and it's pretty significant because 

11 it's such a large amount of material and it's very 

12 concentrated in uranium.

13 The daughter products are the ones that 

14 really can drive things. Especially say the radon. 

15 So, at a thousand years, the build up of the 

16 daughter products, you're only at about one one17 thousandth of the peak dose from the material.

18 MEMBER BLEY: Right.

19 DR. ESH: By ten thousand years you're 

20 within one tenth of the peak dose of the material.

21 MEMBER BLEY: Well, more -- I don't --

22 DR. ESH: It's -- no, it's very 

23 nonlinear, right. It gets good -- it depends on 

24 the ratio of the isotope of U-238 and U-234. The 

25 ratios -- the isotopic fractions of the various 
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1 uranium isotopes.

2 MEMBER BLEY: Right.

3 DR. ESH: But no, you're at about one 

4 tenth of the peak, the other direction. Right. 

5 Yes. So, you're not at 90 percent. You're at one6 tenth.

7 But the view was that if we have to do 

8 something with deleted uranium, if you're only at 

9 one one-thousandth of what you might estimate the 

10 impact to be, you're really missing the target 

11 there.

12 I mean, if you're within one-tenth 

13 given what goes on in performance assessments and 

14 the uncertainties and all the various calculations 

15 and those sorts of things, that's fairly reasonable

16 when you combine it with the performance period 

17 after that.

18 So, the performance period is still 

19 likely to involve quantitative calculations, but a 

20 qualitative interpretation of those calculations. 

21 So, you don't have a firm dose standard for those 

22 very long times. Very long being after ten 

23 thousand years.

24 But you still have somebody doing the 

25 calculation to see what they think is going to 
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1 happen. So, that we felt was an appropriate way to 

2 address depleted uranium or other waste that might 

3 have similar characteristics to depleted uranium.

4 So, greater then Class C waste, CTCC 

5 has the potential to have a very large amount of 

6 long-lived, alpha emitting radionuclides. They 

7 have the same sort of performance issues associated 

8 with them that the depleted uranium will have.

9 So, if you say well, I want to dispose 

10 of GTC -- too many C's. There's two Cs on there. 

11 In a low level waste disposal facility, that would 

12 be a consideration for that waste too.

13 So, the way we structured it with this 

14 kind of tiered approach is we had a lot of comments 

15 that said okay, but should you really be doing ten 

16 thousand years for short-lived waste, traditional 

17 waste that has very low amounts of long-lived 

18 radioactivity.

19 MEMBER BLEY: Right.

20 DR. ESH: And we generally would say 

21 no. You know, you can analyze that for a shorter 

22 period of time. If everything's decaying out of 

23 your system, fine. You know, don't muck up your 

24 calculations with the --

25 MEMBER BLEY: Is the guidance clear on 
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1 that?

2 DR. ESH: The guidance, I hope, is very 

3 clear on that.

4 MEMBER BLEY: Okay. Because I haven't 

5 seen that yet.

6 DR. ESH: Right. Right. So, you have 

7 it on your CD. And I'll point you to where that 

8 discussion is.

9 MEMBER BLEY: Okay.

10 DR. ESH: So but the idea was that in 

11 this -- what we've generated here that has elements 

12 that I think various stakeholders were looking for. 

13 But still has enough technical credibility for that 

14 challenging problem, which was the direction why we 

15 did all this to begin with.

16 So, if we were given that direction to 

17 deal with this difficult waste stream in our low18 level waste regulations, and then we didn't come up 

19 with requirements that we think are appropriate for 

20 that sort of material, then what exactly did we do?

21 So that's, you know, in plain terms 

22 that's what we were attempting to achieve here.

23 MEMBER BLEY: That helps a lot. And I 

24 did not remember that you built up to a substantial 

25 fraction of the daughter.
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1 I've probably got the white paper.

2 DR. ESH: Yes, I was just going to say 

3 that --

4 MEMBER BLEY: But it would be good to 

5 circulate that to everybody.

6 MR. WIDMAYER: Yes, I'll put it back 

7 out. At probably two previous meetings, David's 

8 provided a chart --

9 (Simultaneous speaking).

10 MEMBER BLEY: I remember that, but I 

11 don't remember all the details.

12 MR. WIDMAYER: -- probably gave a 

13 nickname to it, like Esh's Bullseye or something.

14 MEMBER BLEY: This was a good 

15 discussion. Thank you, David.

16 MEMBER REMPE: We forget things. Could 

17 you talk a little bit about uncertainty and how you 

18 are -- that was one of the stakeholder comments, 

19 and the commissioners have said do something about 

20 it -- and how you are dealing with it in the 

21 guidance document, and also a little bit about how 

22 does that compare with the international 

23 community's approach?

24 MR. ESH: Do you want to talk about 

25 that now, or do you want to wait until I get in 
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1 tonight?

2 MEMBER REMPE: If it's in your 

3 presentation -- it wasn't obvious from looking at 

4 the slides, but if it fits better, that's fine, but 

5 I'd like to see it discussed.

6 MR. ESH: Let me try to address it 

7 there, and if I don't, remind me again, and we'll 

8 pick it up there.

9 MEMBER REMPE: All right, thanks.

10 MR. COMFORT: Any other questions? The 

11 other things that we did were basically add a new 

12 requirement to update the technical analyses at 

13 site closure, add a new requirement to identify 

14 defense-in-depth protections and to have -- the 

15 rule will also facilitate implementation and better 

16 align the requirements with the current safety 

17 standards by changing the performance objectives.

18 I'm going to go over, now, the 

19 significant changes to the rule language, going 

20 through the entire rule real quickly. Where we did 

21 a lot of changes were in definitions. We've added 

22 definitions for compliance period. This is where 

23 we set up the 1,000 year and the 10,000 year. As I 

24 indicated, this is Compatibility Category C, so an 

25 agreement state could change this, be more 
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1 conservative on how long they want the compliance 

2 period to be.

3 It would have to be no shorter than 

4 these, but it could be longer. We also added a 

5 definition of defense-in-depth. We believe that 

6 defense-in-depth is already implicit in the current 

7 Part 61, but the commission wanted us to spell it 

8 out and to have licensees identify their 

9 defense-in-depth protections, so we've put in a new 

10 requirement, as you'll in 61.12, I'll get into in a 

11 couple of minutes. Moving on --

12 MEMBER SKILLMAN: Gary, let me ask 

13 this. Compliance period -- why doesn't the 

14 compliance period begin on the day of the rule for 

15 an active site? The way this definition is 

16 written, it means the time from --

17 MR. COMFORT: Site closure.

18 MEMBER SKILLMAN: -- closure. Say one 

19 of these sites is out there for the next 60 years. 

20 It has the legacy inventory been underground for 

21 maybe 30 years. It's receiving inventory for the 

22 next three or four decades. Why doesn't the --

23 what governs from today to the day the site is 

24 closed?

25 MR. COMFORT: They have an active 
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1 license, so the protections from that is where 

2 you'd be getting the health and safety protections. 

3 The idea of the compliance period is after there's 

4 nobody at the site anymore, that you're trying to 

5 evaluate. You have somebody actively at the site, 

6 so if you see issues coming up, you know, they're 

7 going to be doing monitoring and stuff like that 

8 actively at the site --

9 (Simultaneous speaking).

10 MEMBER SKILLMAN: The final rule is 

11 really for low-level radioactive waste disposal 

12 after the site is closed?

13 MR. COMFORT: These new requirements 

14 are for it. There are other requirements on what 

15 they have to do while the site is operating.

16 MEMBER SKILLMAN: I certainly 

17 understand that.

18 MR. ESH: 61.43, the performance 

19 objective, provides for protection of the people 

20 operating the facility and members of the public 

21 during operations. That's where the issue you just 

22 raised would come into play, and all the associated 

23 requirements (Simultaneous speaking).

24 MEMBER SKILLMAN: Let me ask one more, 

25 and this is really an off-the-wall question, but 
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1 I'd like to get it out of my system because I lived 

2 the life, and so did my colleague here. What about 

3 stuff that got dumped at sea? There was a lot of 

4 stuff that went overboard, and it's wherever it is. 

5 How do you think about that in the context of this 

6 rule?

7 MR. ESH: The sea disposal of material 

8 happened in both oceans, of course, the Atlantic 

9 and Pacific. Other countries pursued that, too. 

10 But then I believe it was maybe in the early '70s 

11 that basically, that practice was ended. There was 

12 a moratorium placed on that practice because it was 

13 not viewed as being environmentally responsible, I 

14 guess, or ethical, whatever word you want to 

15 (Simultaneous speaking).

16 MEMBER SKILLMAN: That's all, thank 

17 you.

18 MR. ESH: That was pre-Part 61. The 

19 same sort of logic that applies to the older sites 

20 were closed prior to Part 61 would apply to the sea 

21 disposal -- the material that was disposed at sea.

22 MEMBER SKILLMAN: Thank you.

23 MR. TAPPERT: Just to clarify, on the 

24 performance assessment, you're doing that during 

25 the operation of the facility? You're not 
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1 operating it for 60 years and then applying the 

2 compliance period, right? The compliance period 

3 begins after the site closure, but you're doing 

4 that analysis to inform what's being accepted into 

5 the facility, right?

6 MEMBER SKILLMAN: I appreciate your 

7 comment because that's why I was picking away at 

8 what is compliance period. I'm not suggesting that 

9 something is in error. I was going for clarity. 

10 What I heard the gentleman say is, "While you've 

11 got your license, you're in a different set of 

12 protections. Compliance period really begins when 

13 you close the site and you go to your first 1,000 

14 years. I believe that's what you're trying to 

15 communicate.

16 MR. TAPPERT: Yes, so that's the 

17 compliance period for the analysis period. My 

18 understanding is that you're doing that during the 

19 operation of the facility, and you're updating it 

20 periodically. You don't continue to operate the 

21 facility and then do the analysis at the very end. 

22 Even though that's the compliance period, it 

23 informs the operation of the facility.

24 MR. COMFORT: They have to provide the 

25 performance assessment as part of the initial and 
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1 updated applications that they do. They'll do the 

2 evaluation, so it's not that they're going to all 

3 of a sudden dispose of a bunch of stuff, and then 

4 say, "We're not going to meet these requirements, 

5 and we now have to do something with it. Whether 

6 they should have before -- that they're permitted 

7 to dispose of material that some of these analyses 

8 --

9 MEMBER BLEY: This might not be a fair 

10 question, but since we're writing defense-in-depth 

11 into the rule, were you guys tracking or involved 

12 in, or at least knowledgeable of the fairly recent 

13 NUREG KM, knowledge management on defense-in-depth?

14 MR. COMFORT: We were aware of it, yes.

15 MEMBER BLEY: Are you consistent with 

16 it in any way?

17 MR. ESH: I guess you should tell us 

18 whether we're consistent with it. We looked at 

19 that document when the regulation was developed and 

20 these requirements were developed. I believe we're 

21 consistent with it.

22 MEMBER BLEY: Okay, you're aware of it 

23 and you followed it. Thank you. That's what I 

24 wanted (Simultaneous speaking).

25 MR. ESH: I'm going to talk about 
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1 defense-in-depth and --

2 MEMBER BLEY: I haven't looked 

3 carefully, so maybe we'll let you know if we don't 

4 agree.

5 MR. ESH: I'm going to talk about 

6 defense-in-depth when we get to my part. There 

7 were some challenges with implementing it for a 

8 waste disposal problem compared to, say, other 

9 problems, and I was planning to talk about that.

10 MEMBER BLEY: Thanks, David.

11 MR. COMFORT: We've added a definition 

12 for an inadvertent intruder assessment, as 

13 indicated on it. As I indicated before, one of the 

14 things that it is important to note is that we 

15 changed the scenario, that basically, somebody that 

16 engages in normal activities and other reasonably 

17 foreseeable pursuits that are realistic and 

18 consistent with expected activities in and around 

19 the disposal site at the time of the assessment. 

20 That was, again, a change both from writing this 

21 definition, but it's also from what was in the 

22 proposed rule. It examines the capabilities of the 

23 intruder barriers to inhibit contact with the 

24 waste, and it estimates the inadvertent intruder's 

25 potential annual dose considering uncertainty.
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1 We added a definition for long-lived 

2 radionuclide because that becomes an important role 

3 as to particularly setting the compliance period as 

4 indicated. I won't go over the different ideas. 

5 We added definitions for performance assessment and 

6 performance period, again just to fulfill the 

7 requirement -- to add more definition into what the 

8 rule is and when we use those terms.

9 For example, in the current 61.13, we 

10 talk about technical analyses and technical 

11 analysis. That technical analysis is really what 

12 became the performance assessment. It's one of the 

13 technical analyses that's now required in the new 

14 rule, including the inadvertent intruder assessment 

15 and all. Performance period, as I said, is a time 

16 frame established to provide disposal after the 

17 compliance period, but is not going to be -- it 

18 doesn't have any technical quantitative 

19 requirements or dose limits that you have to meet 

20 on it in our role. Again in compatibility C, so an 

21 agreement state could determine to do something 

22 otherwise. We also added, again, per commission 

23 direction, a safety case. Again, we think the 

24 regulations already have safety case implicitly 

25 involved, but the commission wanted us to more 
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1 explicitly state what a safety case and what makes 

2 it up and have the licensee show that the site that 

3 they're operating on a holistic level is safe.

4 Going to some of the new requirements, 

5 one of the ones I'm pointing out, the 61.12, 

6 because we got a lot of comments on it regarding 

7 defense-in-depth. Originally, this was in the 

8 proposed rule, in 61.13, which is a category of 

9 technical analyses. The way it was written, a lot 

10 of people looked at this was going to be a big new 

11 elaborate analysis that licensees were going to 

12 have to undertake.

13 That wasn't our intent, nor the 

14 commission's intent. To make sure that's not the 

15 case, we moved it to 61.12, which is technical 

16 information. Now we're just basically saying they 

17 have to identify defense-in-depth protections. As 

18 Dave indicated, he'll get into that some more. The 

19 key thing we're trying to say, it's not supposed to 

20 be a brand-new big analysis. 61.13 is where 

21 probably the meat of the rule really is, in the 

22 technical analyses. We've broken this into a 

23 number of analyses that make up all the technical 

24 analyses, or a number of assessments that make it 

25 up. The first one is the performance assessment, 
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1 which is really showing the protection of public 

2 health and safety.

3 It basically relates to the performance 

4 objective in 61.41 for the compliance period, now 

5 that we've defined as -- I have 25 millirem on an 

6 annual basis, but you have to consider the future 

7 events and processes that represent the phenomena. 

8 You consider the likelihood of disruptive -- what I 

9 have listed here is basically a write-down of the 

10 requirements of what you have to do as part of that 

11 performance assessment. Continuing on the 

12 technical --

13 MEMBER BLEY: Can I --

14 MR. COMFORT: Sure.

15 MEMBER BLEY: -- interrupt you for 

16 something? Earlier, it'd be 61.7, you mentioned 

17 this. In 61.7, it talks about if after closure, 

18 the license will transfer to the state or federal 

19 government, if it's US it's DOE, and you don't 

20 regulate that anymore. If it's a state, our 

21 regulations do continue to apply. Two questions 

22 related to this. Are all of the existing 

23 facilities either going to be DOE or are in states 

24 that are agreement states?

25 MR. COMFORT: All of the existing sites 
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1 are in agreement states.

2 MEMBER BLEY: So there's no 

3 (Simultaneous speaking) not in an agreement state, 

4 then what would happen? It's not now, but if one 

5 shows up in a state that's not an agreement state 

6 in the future, the license won't transfer to the 

7 state then?

8 MR. COMFORT: I'll have to turn to Chris 

9 McKenney. I think he's getting up to --

10 MEMBER BLEY: Or is this a hole that 

11 you don't think will ever occur?

12 MR. COMFORT: I'll ask --

13 MR. MCKENNEY: Chris McKenney, NRC. 

14 That is one of the factors of defense-in-depth for 

15 institutional control that's built into the rule. 

16 That's one of those inclusive events of 

17 defense-in-depth that's already built in, that by 

18 requiring either state or federal ownership of the 

19 land for long term, that reduces the probability. 

20 Almost all of them are on state-owned land. One is 

21 an interesting situation is state-leased land. It 

22 will then revert to federal ownership later, which 

23 is U.S. Ecology on the Hanford facility. At that 

24 point, it will revert to the Hanford Nuclear 

25 Reservation in 2063.
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1 But the Barnwell facility's already 

2 owned by the State of South Carolina, and the Texas 

3 facility has, if I remember correctly, joint -- one 

4 cell federal ownership, and one cell's state 

5 ownership, but there's a combined issue there for 

6 some stuff. Those are there for, again, for 

7 defense-in-depth for the institution control is 

8 long term.

9 MEMBER BLEY: I guess what I didn't 

10 understand is should there be a future site that's 

11 in a state that's not an agreement state, then the 

12 way the rule's written, it still reverts to the 

13 state, I guess.

14 MR. MCKENNEY: The state is an option 

15 to have that there be, again, as a long-term 

16 steward, to make sure that there's less possibility 

17 that you don't have to worry about a commercial 

18 entity owning the property and maintaining it from 

19 sale to another party and having an intruder move 

20 on to the site. If it's owned by the state or 

21 federal ownership, it has a higher probability of 

22 not being used for future development of something 

23 other than (Simultaneous speaking).

24 MEMBER BLEY: That kind of makes sense 

25 to me, but it doesn't quite tell me we can't -- I 
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1 don't think NRC can order the states to 

2 (Simultaneous speaking).

3 MR. MCKENNEY: Which is why we don't 

4 rely on them for more than 100 years. That was the 

5 intent of why that was placed in the rule was 

6 because by putting it under state or federal 

7 ownership, it was likely that you could maintain it 

8 as not being used for other purposes, but as just 

9 an unused property, basically, for very long 

10 periods of time. But if it was owned by a company, 

11 then you'd have to rely on deed restrictions and 

12 other things like that, as it was passed from 

13 company to company, or as those corporations 

14 evolved in time. So that's why that situation 

15 occurs.

16 MEMBER BLEY: Okay, thanks. The second 

17 question I had on that one was for the sites that 

18 revert to the DOE after closure, and DOE 

19 regulations apply, do we have harmonization between 

20 this new rule and what DOE is doing, or are we just 

21 doing our own?

22 MR. ESH: Whether the state or the 

23 federal government owns the lands, our regulations 

24 will apply until the license is terminated, I 

25 believe. I don't know. I looked (Simultaneous 
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1 speaking). Even if DOE assumes ownership of the 

2 land, they would be responsible for carrying out 

3 the institutional control activities until the end 

4 of the institutional control period.

5 MEMBER BLEY: Can I read you a sentence 

6 from --

7 MR. ESH: Let's hear from Lisa 

8 (Simultaneous speaking).

9 MEMBER BLEY: Let me read the sentence, 

10 and then go ahead. The sentence I'm looking at is 

11 Item 4. I can't track all of the things, but it's 

12 under 61.7. "After finding of satisfactory 

13 disposal site closure, the commission will transfer 

14 the license to state or federal government that 

15 owns the disposal site." Two sentences. "If the 

16 U.S. Department of Energy is the federal agency 

17 administering the land on the federal government, 

18 the license will be terminated because the 

19 commission lacks regulatory authority over the 

20 Department for this activity."

21 MS. LONDON: Yes, that's what I was 

22 going to say. Once the license is terminated and 

23 DOE is taking ownership, their regulations will 

24 apply.

25 MEMBER BLEY: My question was how does 
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1 this new rule harmonize or not harmonize with DOE 

2 regulations?

3 MR. ESH: If this rule was finalized 

4 the way it is, DOE's regulations would be less 

5 restrictive, so there should be no issue with it 

6 being taken over under DOE's regulations.

7 MEMBER BLEY: Kind of the point I'm 

8 getting at it is --

9 MR. ESH: But the one area where I 

10 would say that's not the case is DOE applies 100 

11 millirem dose limit for a chronic intruder. 

12 Whereas, under these regulations, we have a 500 

13 millirem dose limit for -- whether it's acute or a 

14 chronic intruder. They make a distinction between 

15 an acute and chronic intruder.

16 MEMBER BLEY: Kind of the point I was 

17 getting at is I know there are international 

18 efforts to harmonize regulations. In the nuclear 

19 area, there are similar things within the states. 

20 We're coming up with a new rule that will apply to 

21 some, but not all of these facilities. I don't 

22 even know what fraction would go to DOE and what 

23 fraction would go to the states. Have we tried to 

24 match, so that both the DOE and NRC will be given 

25 the same rules, or is it just you flip a coin which 
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1 site it is, and you get different rules?

2 MR. ESH: No. I wouldn't say -- of 

3 course, the perception could be that, but the -- in 

4 the last letter that we received from the ACRS, it 

5 said don't define, say, the analysis time frames 

6 and do it completely site specific. If that's the 

7 case, then you are going to be using different 

8 values for all different sites.

9 This idea that the NRC and DOE and EPA 

10 and whomever all need to do the same thing, I don't 

11 think that's the case. I think you can have 

12 different regulatory requirements and make 

13 everything work. Whenever I go through the 

14 technical elements of the regulation, I'll talk 

15 about examples where this draft final proposed 

16 approach is already being made to work in the U.S. 

17 for both NRC and DOE.

18 Yes, you could do some harmonization, 

19 but would you then try to harmonize EPA's approach 

20 to management of hazardous waste with the DOE and 

21 the NRC approach to management of radioactive 

22 waste? Those are diametrically opposed, compared 

23 to just arguing over what the proper compliance 

24 period should be. They do a 30-year evaluation 

25 period using a standardized design, and then at the 
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1 end of 30 years, they'll re-assess and decide 

2 whether they still need to maintain the proper 

3 controls and restrictions in place. That's a lot 

4 different approach then what's being done waste 

5 disposal in the NRC commercial side and the 

6 Department of Energy.

7 MEMBER BLEY: As you go through your 

8 presentation, if you'd point out the places where 

9 things are different between this proposed rule and 

10 the DOE regulations, I'd appreciate it.

11 MR. ESH: I would argue that there is a 

12 difference right there, of course, but there are a 

13 lot of things that are very similar. Do they need 

14 to be identical? I don't think they need to be, 

15 partly because in the commercial side, the NRC's 

16 philosophy is that you're going to release these 

17 sites at some time in the future, and that the 

18 present generation has made proper and good 

19 decisions as to how to manage that material.

20 It's not going to create an impact to 

21 somebody in the future, whether that is a health 

22 and safety impact, or whether that's a financial 

23 impact. If you want to say I'm going to provide a 

24 much longer period of, say, institutional control 

25 to manage the waste, then that comes with financial 
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1 implications. On the public side, or on the 

2 commercial side, we have financial assurance 

3 requirements associated with how much money you 

4 need to put aside to meet your obligations. Those 

5 can be significant in some cases. If you extend 

6 the time that you're going to control it, you're 

7 going to greatly increase the size of those 

8 obligations that you may need to put aside to do 

9 all the activities that you may need to do.

10 On the Department of Energy side, I 

11 don't believe they, when they're self-regulating, 

12 that they have those same sorts of financial 

13 assurance requirements because they receive funding 

14 from Congress to do all their activities and 

15 Congress, year after year, maintains their funding 

16 to make sure they can meet their obligations. 

17 There's some differences like that that you have to 

18 keep in mind whenever you're talking about -- yes, 

19 at the highest level, I agree with you completely.

20 We should all be able to come to the 

21 same point. But when you start getting down to the 

22 implementation stage and look at some of the 

23 differences, it makes sense why there could be some 

24 differences between the requirements. They may be 

25 presented as being difficult and extreme, but from 
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1 a practitioner, and the other practitioners I talk 

2 to, they don't view them the same way. What you 

3 may receive from some stakeholders as to how 

4 significant of an issue this is, you'll receive a 

5 lot different message from other stakeholders. The 

6 practitioners don't view this as, generally, it's 

7 as big of an issue as maybe some of the 

8 policymaker-type stakeholders.

9 MEMBER BLEY: I'm going to chase this 

10 just a little further. Thanks for that 

11 explanation. I like that. Are those kind of 

12 arguments laid out in the statements of 

13 consideration or somewhere else? We don't have the 

14 statements of consideration.

15 MR. WIDMAYER: Yes, it's part of the 

16 red package I gave you.

17 MEMBER BLEY: It's in this package? 

18 It's not called statements of consideration in that 

19 package.

20 MS. LONDON: It's in the Federal 

21 Register notice.

22 MR. COMFORT: The draft Federal 

23 Register notice includes the statements of 

24 consideration. No, it won't get into that -- it 

25 won't get into this harmonization issue in there at 
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1 all and stuff on it. Part of it --

2 (Simultaneous speaking).

3 MEMBER BLEY: The arguments were pretty 

4 interesting about commercial versus a tax-supported 

5 operation, but that's not anywhere in there?

6 MR. COMFORT: Yes, we didn't get a 

7 question specific to that that would have been 

8 answered that way. The actual rule language that 

9 you're addressing in 61.7 regarding the states and 

10 all has not changed. That's in the existing 

11 regulations anyways and stuff. The part that we 

12 may want to look at is the statements of 

13 consideration for that rule, which I guess they 

14 really didn't have one. They had the environmental 

15 impact statement to see if they were -- what they 

16 were envisioning in the way of the turnover to a 

17 state or Department of Energy and stuff on it --

18 MR. WIDMAYER: Hey, Dennis.

19 MR. COMFORT: -- but it does not 

20 discuss this at all.

21 MEMBER BLEY: Thanks, Gary.

22 MR. WIDMAYER: One of the parties that 

23 wants to make comments this afternoon is the 

24 Department of Energy, so you'll hear from them

25 later on in the day.
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1 MEMBER BLEY: I was figuring that would 

2 happen.

3 MR. COMFORT: Okay, continuing on, 

4 another part of the technical analysis, and a big 

5 one, is the new inadvertent intruder assessment for 

6 the compliance period. It requires that -- it 

7 assumes the inadvertent intruder occupies a 

8 disposal site and engages in normal activities and 

9 other reasonable foreseeable pursuits that are 

10 consistent with the activities and pursuits 

11 occurring in and around at the time of the 

12 development of this intruder assessment, as I 

13 indicated in the definition.

14 It's updated prior to closure, and it 

15 identifies barriers to inadvertent intrusion that 

16 inhibit contact with the waste or limit exposure, 

17 and it provides the basis for the time period over 

18 which the barriers are effective. Finally, it 

19 accounts for the uncertainties in variability in 

20 the projected behavior of the disposal site and 

21 general environment. This relates to the 

22 performance assessment in 61.42, which, for the 

23 compliance period, has an annual dose limit of 500 

24 millirem, which is new, which is not in the current 

25 rule now.
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1 CHAIR CHU: Can I ask a quick question?

2 MR. COMFORT: Sure.

3 CHAIR CHU: The intrusion scenario, 

4 within the compliance period, do you do one-time 

5 assessment, or several, or what? It's not clear to 

6 me.

7 MR. ESH: The intruder assessment 

8 covers the whole compliance period. If you had 

9 significant quantities of long-lived waste, then 

10 the performance period, also. The evaluation would 

11 look at intruder impacts --

12 CHAIR CHU: (Simultaneous speaking.)

13 MR. ESH: Yes, it'd calculate the 

14 intruder impacts over the whole time period, and 

15 then generally pick the peak value within the time 

16 period.

17 MR. COMFORT: Dave, I think, will get 

18 into more on that. The types of scenarios I think 

19 that we have them look at are relatively defined on 

20 it. In addition, in 61.13, Item C, D, and E, are 

21 that you do it announced as a protection of 

22 individuals during operations. That hasn't changed 

23 from what's currently in the regulation. We have a 

24 long-term stability analysis.

25 Again, that's required in the current 
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1 regulation. The big change is that it now has a 

2 time period that you have to associate that 

3 stability analysis with. Then we've added this new 

4 performance period analysis, which is only required 

5 if you have to do a 10,000-year compliance period 

6 for the performance assessment or for the 

7 inadvertent intruder assessment. It basically 

8 looks at how the site would limit the potential 

9 long-term radiological impacts, consistent with the 

10 available data and current scientific 

11 understanding. There's no dose limit associated 

12 with that. It's just basically try to minimize 

13 doses that you can find or seem to be a reasonably 

14 achievable level in the far future. But again, 

15 with all the uncertainties, that's why we decided 

16 not to put a limit on that.

17 We had some other changes throughout, 

18 again, editorial, but the next area where there's a 

19 significant change in the performance objectives is 

20 61.41. Again, this is basically added a 25 

21 millirem dose limit for the protection of the 

22 public. We've defined a compliance period, rather 

23 than just for the assessment, in general. It 

24 basically stays the 25 millirem limit. However, 

25 the previous was based on methodology, older ICRP 
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1 methodologies.

2 We've updated the language in there so 

3 that the more modern methodologies or more recent 

4 methodologies can be used. It's, as I said, 

5 demonstrated through the analyses for the 

6 performance assessment that are specified in 

7 61.13(a). For the performance period, as I said, 

8 it must minimize the releases to radioactivity to 

9 the general public, to the extent reasonably 

10 achievable. That's basically the qualifier on it, 

11 and it's demonstrated through 61.13(e), which I had 

12 just shown you. 61.42 is basically the performance 

13 objective for the inadvertent intrusion. This is 

14 where there was no limit before. It was basically 

15 evaluate it and keep it reasonable. Now we've put 

16 a limit of 500 millirem to the inadvertent 

17 intruder, which is demonstrated through the 

18 analysis that we discussed for 61.13(b).

19 Similar to the 61.41 requirement, the 

20 performance period, you have to minimize exposures 

21 to inadvertent intruders to the extent reasonably 

22 achievable. The final area that I'm going to go 

23 over is really the draft final -- is 61.58, which 

24 is the alternative requirements for waste 

25 classification. In the current rule -- well, this 
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1 section was really replaced in its entirety.

2 The original 61.58 allowed the 

3 commission to authorize provisions for the 

4 classification and characteristics on a specific 

5 basis if there were reasonable assurance that the 

6 performance objectives of Subpart C in 10 C.F.R. 

7 Part 61 could be met, so basically the 61.41, 

8 61.42. In this draft final rule, we've replaced 

9 requirements to better specify a process for 

10 requesting and approving alternative requirements 

11 for waste classification by specifying the waste 

12 acceptance criteria must be provided and specify, 

13 at a minimum, the allowable activities and 

14 concentrations, the acceptable waste form 

15 characteristics, and identifying restrictions or 

16 prohibitions on the waste materials or containers 

17 that might affect the facility's ability to meet 

18 the performance of objectives.

19 The final rule also requires that the 

20 applicant provide acceptable methods for 

21 characterizing waste for the acceptance and program 

22 to certify the waste. These programs are required 

23 to be reviewed annually by the licensee. Really, a 

24 overview of the big ideas of the changes. Dave, in 

25 his presentation, will be getting into more of the 
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1 technical basis for it and how the changes will 

2 work through guidance and all of this stuff. Are 

3 there any questions I have before we potentially 

4 take a break or move over to Dave?

5 CHAIR CHU: I have a question on the 

6 performance period analysis. Are these 

7 quantitative or qualitative?

8 MR. COMFORT: The results are evaluated 

9 qualitatively. You can develop a quantitative 

10 evaluation. A lot of times, it may just be running 

11 out your model that you've already developed and 

12 keeping things consistent.

13 (Off mic comment)

14 MR. COMFORT: Right, but we're not 

15 requiring you to meet a certain limit or anything. 

16 It's more to give an idea of what's the potential.

17 CHAIR CHU: Even if it peaks a lot?

18 MR. COMFORT: That's what you're trying 

19 to evaluate. If you see a huge peak somewhere in 

20 the future, when you run it out past -- in this 

21 performance period, the regulator may say, "If 

22 there's something that can be done about it, we may 

23 want to do something about it."

24 CHAIR CHU: Because I was thinking of 

25 what, Dave, you said earlier about depleted 
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1 uranium. In 10,000 years, only 10 percent decayed.

2 MR. ESH: At 10,000 years, you're only 

3 at about one tenth of the peak risk is what it is 

4 generally. Of course, that would depend -- that's 

5 just from a radiological decay and in growth 

6 perspective. When you move to a real system and, 

7 say, you put that waste in a disposal facility and 

8 you analyze what the impacts to the drinking water 

9 are, or an inadvertent intruder, the peak may occur 

10 a lot earlier than the peak radiological time. The 

11 peak radiological time is something like 2.1 

12 million years, but in the dose assessment, the 

13 peaks may occur earlier. It would depend on your 

14 specific site physics and chemistry, that sort of 

15 thing.

16 CHAIR CHU: I was just wondering have 

17 you done any reference case calculation way beyond 

18 10,000 years to test that performance period, see 

19 what happens?

20 MR. ESH: Not specifically in, say, 

21 this iteration of the rulemaking, but back in 2008 

22 time frame, whenever we looked at can you even put 

23 depleted uranium in a near-service disposal 

24 facility, we ran calculations out to much longer 

25 time then. The general messages from that were 
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1 that you're going to be very challenged to put that 

2 material in a human site, and you're going to be 

3 very challenged to put that material in a shallow, 

4 arid site. You need to start getting the material 

5 fairly deep, in order to knock the radon impacts 

6 down.

7 MR. COMFORT: Any other questions?

8 MEMBER KIRCHNER: Yes, I have a 

9 question. You mentioned earlier that several of 

10 the agreement states would take a longer time of 

11 compliance. When they do that, is the 

12 justification for that just to be conservative, or 

13 does it fit in with your long-lived radionuclides 

14 definition?

15 MR. ESH: I can't answer, necessarily, 

16 why the agreement states may have used different 

17 values. Originally, prior to starting this 

18 rulemaking activity, all the existing facilities 

19 were located in four agreement states. The 

20 analysis time frames that they used ranged from 500 

21 years to 1,000 years or peak dose, whichever is 

22 longer. For that particular case, their peak was 

23 at approximately 50,000 years.

24 Their compliance periods that the four 

25 sites used ranged from 500 to 50,000. As we went 
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1 through this rulemaking process, the one agreement 

2 state that had used 500, they had a proposal from 

3 their licensee to dispose of larger quantities of 

4 depleted uranium, so they did a revision to their 

5 rulemaking to specify requirements for large 

6 quantities of depleted uranium.

7 For that, then, they look at 10,000 

8 years, and they do a longer term analyses. Their 

9 new requirement mimics what's in our draft final 

10 rule pretty well. As to why they picked those 

11 different values, I think it's part of what you may 

12 have heard if you were part of the subcommittee or 

13 full committee at previous meetings in all this 

14 last eight, nine, or ten years that we've been 

15 discussing it. There's a big diversity of opinion 

16 on the topic. It can be quite subjective. 

17 Everybody has an opinion, and they tend to all be 

18 different. The thing that I have looked at in both 

19 the response to comments and in the draft final 

20 approach is right now, all of these facilities are 

21 in agreement states. The agreement states do the 

22 regulation, and in most cases, the states have to 

23 receive the facility after closure from the 

24 licensees.

25 They have standards on the book that 
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1 they've used to license their existing facilities. 

2 Who am I, sitting here in Washington, to come and 

3 say, "No, you've got it all wrong. You need to do 

4 it this way." They have to make the decisions 

5 based on their processes and rulemaking and 

6 interaction with their state stakeholders what they 

7 think is appropriate to do for that facility in 

8 their state.

9 Because it's not something that I think 

10 you can pull a number and say absolutely, this is 

11 the perfect number for it, then we should afford 

12 flexibility to them to look at the problem in a 

13 manner that they think is suitable for their 

14 agreement states and to managing -- go ahead.

15 MEMBER KIRCHNER: I might invert my 

16 question, then. Once you promulgate this final 

17 rule, would any of the agreement states be less 

18 conservative, not bounded by the rule?

19 MR. ESH: No, all of the agreement 

20 states -- South Carolina has -- they've used an 

21 analysis of up to 2,000 years in their technical 

22 evaluation. They don't have a requirement -- or 

23 they haven't done an intruder assessment. In the 

24 existing rules going forward, if they determine 

25 that they do not have significant quantities of 
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1 long-lived radionuclides, then they would be fine 

2 because they could use 1,000, or they could keep 

3 their 2,000 if they want, whatever they choose.

4 If they found that they did have 

5 significant quantities of long-lived radionuclides, 

6 then they would get pushed up to the 10,000. 

7 Otherwise, the other three existing agreement 

8 states are all at or greater than the requirements 

9 that we've proposed.

10 MEMBER REMPE: You don't know whether 

11 they have long-lived radionuclides? Surely, they 

12 know (Simultaneous speaking).

13 MR. ESH: No, they have long-lived 

14 radionuclides in their facility. As I'll outline 

15 when I talk about it, half of that decision -- or 

16 the part of the decision associated with the 

17 inadvertent intruder, where it's much more 

18 straightforward to determine what is significant. 

19 For 61.41, the protection of the public through 

20 releases of the facility that might occur, say, 

21 into an aquifer or if you had erosion at the 

22 facility or those sorts of things, release to 

23 surface water, those are much more site-specific 

24 calculations. What's significant for one site can 

25 be a lot different than what's significant for 
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1 another. Without having the details of their 

2 hydrogeology and all the things that might go into 

3 that, it's hard for me to say, clearly, whether 

4 they are in the camp of having significant or not.

5 They have some long-lived 

6 radioactivity, and based on the fact that their 

7 waste was pretty similar to what's generated 

8 commercially, without any special waste streams, my 

9 educated guess would be that they don't have 

10 significant quantities of long-lived isotopes, but 

11 it would depend on some of the details of the 

12 problem. Based on inventory, alone, and the fact 

13 that they're a humid site, it makes it much more 

14 challenging for them to make that argument than it 

15 does, say, for a site in Utah or a site in West 

16 Texas.

17 MEMBER REMPE: Thank you.

18 CHAIR CHU: Any other questions? If 

19 not, I suggest we take a break. We'll come back at 

20 five until 3:00. Thank you.

21 (Whereupon, the above-entitled meeting 

22 went off the record at 2:40 p.m. and went back on 

23 the record at 2:56 p.m.)

24 CHAIR CHU: Let's resume the meeting 

25 and have Dr. Esh give his presentation.
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1 MR. ESH: Thank you, Dr. Chu. Thank 

2 you for your kind introduction earlier. To me, 

3 that's really a reflection of who I work with, 

4 rather than my own abilities. I'm going to give 

5 you an overview of the major technical elements of 

6 10 C.F.R. Part 61. Before I do that, I'd like to 

7 recognize some of the people that aren't here that 

8 have contributed to that.

9 Of course, you've heard from Gary 

10 Comfort, but also, we had Andrew Carrera in 

11 rulemaking that did a significant amount of work on 

12 this project, Chris Grossman, who's on the 

13 telephone, and Hans Arlt, from my group in 

14 performance assessment, Lisa London, who you heard 

15 from earlier, from our office of general counsel, 

16 Tim McCartin, senior level advisor in all things 

17 waste, I would say.

18 I don't know what his particular title 

19 is. We had members from agreement states on our 

20 working group that provided valuable input to this 

21 process. Then in the low-level waste branch, our 

22 current project manager, Steve Dembek and Priya 

23 Yadav, who's our excellent project manager on the 

24 guidance document. All of those people had 

25 significant contributions to this project. We also 
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1 would like to indicate that we appreciate the time 

2 and effort of all the commenters and stakeholders 

3 in this process. I'm particularly impressed by 

4 members of the public when they give their time for 

5 something like this. Everybody's time is valuable.

6 They come in the evening and listen to 

7 the meetings for three hours and read some pretty 

8 substantial documents. That's impressive to me 

9 when we get that sort of input from members of the 

10 public. We did our best to respond to all the 

11 comments, which was part of the package.

12 The draft final rulemaking package has 

13 been through review at, basically, all levels of 

14 the NRC, except the commission, and except your 

15 committee, possibly, but it went through the full 

16 concurrence process on its way up there. Of 

17 course, not everybody is going to be happy with the 

18 final outcome, but that's generally impossible to 

19 do when you have some pretty diverse and strong 

20 opinions on some of the topics.

21 MEMBER BLEY: Sorry to interrupt. That 

22 statement that everything's been reviewed all the 

23 way up, does that include the NUREG?

24 MR. ESH: Sorry, no. The NUREG is at a 

25 little bit slower pace than the rest of the 
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1 package. I've kind of learned, through my 

2 experience, that maybe a good rule of thumb for a 

3 regulator is if everybody's kind of unhappy with 

4 you, then you've done a good job, so we'll see. 

5 Next slide, please, Gary.

6 The outline I'm going to follow is a 

7 little bit different than if you just picked up the 

8 regulation and started reading through it because 

9 some of these pieces kind of fit into others. This 

10 is more of a top-down view of the technical 

11 elements of the regulation. I'll start off with 

12 the safety case, which is kind of the overarching 

13 summary of the arguments for why you believe the 

14 facility is safe.

15 A lot of information flows into the 

16 safety case, but the two primary ones are the 

17 identification of the defense-in-depth protections, 

18 and then the technical analyses. They provide much 

19 of the basis for the safety case. But that isn't 

20 to diminish many of the other components of the 

21 regulation that might, in some respects, play an 

22 equally important role in the overall safety case. 

23 The analysis time frames I'll discuss because it is 

24 an area of interest to a lot of stakeholders. The 

25 way I would describe it is it kind of provides a 
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1 boundary condition for the technical analyses. 

2 What you decide with analysis time frames can then 

3 condition or dictate what you need to consider in 

4 your technical analyses. As you heard earlier, 

5 part of the approach in the final rule is to try to 

6 make a distinction between "normal waste" and waste 

7 that may contain significant quantities or higher 

8 amounts of long-lived radionuclides.

9 The technical analyses that I'll 

10 discuss, I'm going to describe the performance 

11 assessment, intruder assessment, and site stability 

12 analyses. Then all of that information can flow 

13 into the waste acceptance requirements. As Gary 

14 discussed, the waste acceptance requirements or the 

15 waste acceptance criteria can be based on the waste 

16 classification tables in Part 61, Table 1 and Table 

17 2, or they can be based on the results of the 

18 technical analyses, or they can be a combination of 

19 both.

20 I'll go through that approach in the 

21 waste acceptance requirements because the waste 

22 acceptance requirements are really how you put 

23 something in place that ensures that all the 

24 analysis and evaluation you did in developing the 

25 licensing of the facility is going to be achieved 
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1 in the actual facility. We'll talk about the 

2 guidance document in a kind of high-level form, but 

3 any of these things I talk about or areas I don't 

4 talk about, if you have questions when I'm done, 

5 hopefully we have enough time. Feel free to talk 

6 about any things, whether I talked about them in 

7 the slides or not.

8 MS. YADAV: Dave, can I add one 

9 comment?

10 MR. ESH: Yes, go ahead.

11 MS. YADAV: Hi, this is Priya Yadav. 

12 I'm glad you guys can hear me and Chris Grossman. 

13 We were trying to say a couple things a little 

14 earlier, but we were on mute. I just wanted to

15 add, on the guidance -- because I know that it is a 

16 long document -- on the CDs that you have, I also 

17 added a file that's called, "Please Read Me First." 

18 I thought hopefully, you might glance at it and 

19 read it. Dave and I and Chris just tried to kind 

20 of pick the most important areas for you to look at 

21 first, since it is so voluminous.

22 We identified, "Look in this section 

23 for a discussion of significant quantities. Read 

24 this section carefully." It's just a quick one 

25 pager, saying, "Here are the most important 
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1 sections that you might want to start with." Of 

2 course, all 500 pages are available to you, as an 

3 official use only copy. Right now, it's not 

4 publicly available, just because we don't want to 

5 have multiple versions of a NUREG out before the 

6 rule is not changed anymore. After we get 

7 definition on the rule, that it's final, then we'll 

8 issue the publicly available version of the NUREG. 

9 So the OUO copy you have on CD is for your use, but 

10 I hope that the Please Read Me file helps you in 

11 what areas to start with.

12 MR. ESH: Thank you, Priya. On Slide 

13 3, the first item I'll talk about is the safety 

14 case. The safety case is a collection of arguments 

15 and evidence to demonstrate the safety of the land 

16 disposal facility, e.g. the defense-in-depth 

17 protections and the technical analyses. Our 

18 representation of safety case is quite similar to 

19 the international atomic energy agencies, but not 

20 identical.

21 There are some differences between what 

22 we're considering a safety case and how they would 

23 describe a safety case. Those differences 

24 primarily arise from the role of stakeholders in 

25 their processes, and also the fact that in the 
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1 IAEA's vision, for many of their member states, 

2 they will do multiple safety cases. They'll do a 

3 safety case for site selection. Then they'll do a 

4 safety case to determine whether they can construct 

5 the facility. Then they'll do a safety case for 

6 operations, a safety case for post-closure, and so 

7 on and so forth. Whereas, in the NRC licensing 

8 process for low-level waste, we basically do one 

9 safety case for the whole thing. You could maybe 

10 make an argument that we're kind of doing two 

11 because once you get to the closure point, which 

12 may be a considerable distance in the future, you 

13 might be doing, essentially, another safety case 

14 then, if your information has changed 

15 significantly.

16 If your information has not changed 

17 significantly, then I would make the argument 

18 you've only done one safety case. It's the 10 

19 C.F.R. Part 61 licensing process. But the safety 

20 case is to describe all relevant safety aspects of 

21 the disposal site and things like the design, the 

22 managerial controls, the regulatory controls, all 

23 of that feeds together to make the safety case.

24 Much of the information for the safety 

25 case is already in the existing 10 C.F.R. Part 61 
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1 requirements, under 10 C.F.R. 61.10 through 10 

2 C.F.R. 61.16. The idea is that the safety case 

3 will be updated over time, as new information is 

4 gained during the various phases of the facility, 

5 but depending whether that update is simple or 

6 significant depends on, No. 1, how much your 

7 information has changed and, No. 2, how much margin 

8 you may have built into your facility to begin 

9 with. If you are smart about your design and maybe 

10 do a good job at anticipating changes that may 

11 occur over time or things that might stretch your 

12 system, then your safety case is going to be a 

13 pretty robust argument through time, no matter what 

14 phase of the facility operation or closure, that 

15 sort of thing, you may be in.

16 Next slide, please. The main point, 

17 and the main view of the safety case from us, is 

18 that it should be a plain language description. 

19 You're kind of looking at an executive summary of 

20 your licensing basis for the safety of the 

21 facility. You'll describe the strategy for 

22 achieving the safe disposal, the safety arguments 

23 that go into that, describe your site and facility, 

24 provide information about the characteristics of 

25 the waste and the design and the proposed operation 
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1 of the facility, and then also summarize the 

2 technical analyses, the strategy for institutional 

3 control, and the licensee's financial 

4 qualifications.

5 This description should be something 

6 that is understandable by many. It may be 

7 technical, but it doesn't have to be. But it 

8 should, in a concise form, summarize all the key 

9 features that go into making the safety argument. 

10 The safety case was added, as Gary had indicated, 

11 based on direction from the commission that we 

12 received on the prior rule, as published. Go 

13 ahead, Gary. On Slide 5 here, now we'll move into 

14 defense-in-depth, which is one of the components 

15 that feeds into the safety case. The definition is 

16 up here at the top. I'm going to read it.

17 "The use of multiple independent and, 

18 where possible, redundant layers of defense, so 

19 that no single layer, no matter how robust, is 

20 exclusively relied upon." One thing that we wanted 

21 to do here, NRC has existing definitions of 

22 defense-in-depth. We did want to deviate and come 

23 up with multiple definitions of defense-in-depth. 

24 We thought that's going to be confusing to people, 

25 and people may say, "Why do you have a different 
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1 definition? Which definition should I use?"

2 We felt that it was much better to 

3 have, as much as we could, a single definition 

4 because defense-in-depth is really a principle, and 

5 it shouldn't change depending on the application. 

6 But in the case of a waste disposal facility, there 

7 are some pretty substantial differences than many 

8 other nuclear facilities because the waste disposal 

9 facility, at least as you progress out in time, 

10 their reliance on active safety systems and 

11 controls diminishes, and it becomes almost totally 

12 reliant on passive safety systems and controls. At 

13 the bottom of this diagram, you see the various 

14 arrows here. That's just increasing time from left 

15 to right, but it's basically indicating the various 

16 things that may come into play to make a 

17 defense-in-depth argument.

18 Those include personnel controls, 

19 active barriers, passive barriers. But the bottom 

20 big arrow is different phases or different life 

21 cycle time frames of the facility. You see that 

22 the items above it, the various types of 

23 defense-in-depth protections, may diminish as you 

24 go out in time, especially the impact of personnel.

25 Because after the institutional control 
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1 period, generally, you're not going to have any 

2 personnel there, and the same thing with controls 

3 and active barriers because there'll be nobody 

4 there to maintain an active barrier. Examples of 

5 defense-in-depth protections can include things 

6 like the site characteristics and the waste 

7 characteristics. This feature was also added in 

8 response to commission direction. As I indicated, 

9 a challenge with the waste disposal is that it is 

10 different from active and other nuclear facilities, 

11 in that you are relying more heavily on passive 

12 components and less heavily on active components. 

13 So the problem came into play, especially with the 

14 word redundant in the layers of defense. We had 

15 this question -- this was an area of question from 

16 a variety of stakeholders. They said, "What does 

17 that mean for a waste disposal system, then?"

18 Say in a reactor, you have a pump and a 

19 backup pump. In a waste disposal system, you have 

20 a drainage layer and an engineering cap. Does that 

21 mean you have a backup drainage layer and the 

22 engineering cap? What we basically explained, and 

23 especially in the guidance, is that we're looking 

24 for redundancy at the functionality of what you're 

25 trying to achieve, but not necessarily redundancy 
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1 of the layer or barrier itself.

2 If minimizing water flow to the waste 

3 is very important to you, then you should have some 

4 redundancy of trying to prevent the water flow to 

5 the waste, not that you have to have redundant 

6 barriers to achieve that function. You can, if 

7 that's the way you choose to go about it. But the 

8 other important point, then -- sorry, next slide, 

9 Gary. The other important point, though, is that 

10 as we discussed earlier, we aren't asking for 

11 defense-in-depth analyses. We're asking for 

12 identification for the defense-in-depth protections 

13 commensurate with the risks. We want the licensees 

14 to describe the capabilities of their 

15 defense-in-depth protections and provide a 

16 technical basis for those capabilities.

17 The requirement, as formulated now, 

18 provides considerable flexibility for how somebody 

19 demonstrates that they meet these requirements 

20 associated with defense-in-depth protections. They 

21 are not prohibited from doing what I would call 

22 defense-in-depth analyses. If I was faced with the 

23 problem, that's what I would do.

24 I would be most straightforward and 

25 more quantitative and less subjective, but they 
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1 aren't necessarily required -- they aren't required 

2 to do that. They're only required to identify the 

3 protections, so it may take a more qualitative 

4 form, the description of how they've achieved the 

5 defense-in-depth requirements. Next slide, Gary.

6 As I indicated, operations and 

7 post-closure may have some differences based on the 

8 phase of the facility you're in. During 

9 operations, you can have both active and passive 

10 safety systems commensurate with the hazard and 

11 complexity of activities. Whereas, when you move 

12 to the post-closure phase, you're really looking at 

13 essentially just the passive features of the 

14 system. Post-closure is, of course, after the 

15 closure and, really, after the institutional 

16 control period. After closure of the facility, 

17 only if problems were identified would you imagine 

18 that there's going to be changes to the design or 

19 other sorts of activity at the facility.

20 Otherwise, the institutional control 

21 period is mainly a passive monitoring of the 

22 facility performance and active monitoring of -- or 

23 preventing access to the site. There are some 

24 benefits associated with defense-in-depth that are 

25 identified here. Under the post-closure one, I'd 
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1 say it's the second and fourth items.

2 Defense-in-depth, we believe, provides 

3 the diversity of the capabilities associated with 

4 defense-in-depth of the components and the 

5 attributes, provides you more resilience to 

6 unexpected failures or external challenges. Then 

7 in addition, the use of defense-in-depth should 

8 help mitigate some uncertainties or lessen the 

9 impact of uncertainties. It's not going to 

10 mitigate all uncertainties, but it can help you 

11 mitigate some of the uncertainties. The 

12 defense-in-depth is made to work with and not 

13 inhibit, in any way, the demonstration of 

14 compliance with the performance objectives. Those 

15 two things work together to provide information 

16 that supports the overall safety case. Next slide.

17 CHAIR CHU: Dave?

18 MEMBER BROWN: Go ahead, Margaret.

19 CHAIR CHU: Can I ask you to give some 

20 specific examples of post-closure defense-in-depth 

21 specifically (Simultaneous speaking)?

22 MR. ESH: The defense-in-depth for 

23 post-closure, you're really looking at the passive 

24 performance of the system. That's going to be 

25 things like your engineered cover. Even though 
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1 it's an engineered cover, and some engineered 

2 covers, based on their design, might require more 

3 active efforts to maintain them, many of them can 

4 have some passive performance credit to them.

5 Department of Energy, at the Hanford 

6 Site, has the Hanford barrier that they've done a 

7 lot of work on and tried to evaluate how much 

8 passive performance you might expect from that sort 

9 of engineered cover. They've even looked at things 

10 like fires, kind of unlikely events that you might 

11 expect and how they might stress the system. Then 

12 as you move into the system, of course, if you have 

13 waste forms for some types of waste, the waste form 

14 is going to have passive performance in the system. 

15 You might have an engineered cover that helps limit 

16 infiltration or release of the waste, and the waste 

17 form, itself, might help limit infiltration 

18 contacting the radioactivity that's embedded in it 

19 or encapsulated, depending on the design, and then 

20 the release from it.

21 You could also, in some cases, have 

22 waste containers that might have some performance 

23 credit. That's generally more rare in the 

24 commercial side of low-level waste disposal, but 

25 certainly, people aren't prohibited from using an 
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1 engineered container and taking credit for it as a 

2 barrier. That's an example with respect to 

3 infiltration.

4 I would look at the arguments -- also, 

5 say if I was a location that was a very arid site, 

6 that arid site is a barrier to release or a 

7 component to the argument to release because you've 

8 selected a location where the precipitation is very 

9 low, and the infiltration rate is low. That's one 

10 of your active parts of selecting the facility to 

11 make your safety argument that provides you some 

12 confidence that you're going to be meeting the 

13 criteria. That sort of thought, that's just an 

14 infiltration example, but we could go through other 

15 ones, transport and things like that.

16 MEMBER BROWN: Could I ask a question 

17 here, also?

18 MR. ESH: Yes.

19 MEMBER BROWN: Back when you answered 

20 my question relative to active site, old stuff, 

21 when it has to be evaluated for compliance, in 

22 accordance with the new rules, which, I guess, 

23 includes defense-in-depth compliance evaluations, 

24 does that mean they have to dig it back up if you 

25 find you don't comply?
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1 MR. ESH: Right. This is a question 

2 that came up in the public comment process and has 

3 come up multiple times in our eight or nine years 

4 that we've been discussing it. This idea that if 

5 you're not in compliance, you need to take some 

6 action is always in place. NRC, we regulate a 

7 facility.

8 We have requirements you're attempting 

9 to meet. We then inspect and verify and monitor 

10 that you are meeting the requirements. If you're 

11 not meeting the requirements, then some action is 

12 taken to get you into compliance and meet the 

13 requirements. You could, hypothetically, identify 

14 a situation where a facility has a challenge 

15 meeting the compliance criteria in the future. 

16 They would have to come forward and say what 

17 actions they're going to take to try to mitigate 

18 the impacts of that.

19 MEMBER BROWN: But you changed the 

20 rules. You've changed the rules on them after --

21 the stuff could have been there for 10 or 15 years, 

22 and now you've changed the rules. Now you're going 

23 to say, "We've got new rules." It seems like their 

24 only recourse to make compliance would be to come 

25 back and dig it up, put more barriers around it, 
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1 etc. Is that --

2 MR. ESH: Digging it up would be the 

3 last action you would take, I would believe. I 

4 think at first, you would see if there were 

5 barriers you could put in place to mitigate the 

6 impacts. Secondly, you might even do a risk 

7 analysis to look at the socioeconomic 

8 considerations -- the technical plus socioeconomic 

9 considerations to see whether it's justified to 

10 take that action.

11 Because you have a hypothetical dose 

12 impact sometime in the future. You have a real 

13 impact from doing remediation or digging up 

14 radioactivity. We deal with this all the time in 

15 decommissioning, where there's actual material in 

16 the environment that somebody has to decide whether 

17 to take action for and what action to take. That's 

18 not unique to this problem. The existing 

19 requirements in Part 61 are silent on -- say if 

20 you're coming at this from an analysis time frame 

21 standpoint, they're silent on what the compliance 

22 period is. The intruder protection performance 

23 objective says the intruder must be protected at 

24 any time in the future. Is that changing the 

25 requirements on them if now, we specify a time, if 
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1 you go from any time to specifying a time? I would 

2 say any time encompasses any time.

3 MEMBER BROWN: It sounds like mouse 

4 milking to me. You answered my question. I 

5 understand your point. I just wanted to make sure 

6 I understood the thought process. You're kind of 

7 bouncing around a little bit. There's a lot of 

8 things to think about, which take time to assess 

9 and all types of other things.

10 MR. ESH: I don't think that the -- we 

11 don't have Charlie Brown and Lucy going on here.

12 MEMBER BROWN: That's me.

13 MR. ESH: I know you're Charlie Brown.

14 (Simultaneous speaking.)

15 MEMBER BROWN: Should I take that with 

16 a grain of salt, or should I be angry?

17 MR. ESH: That's purely by accident. 

18 We aren't intending to change the target on 

19 somebody. There are some considerations that --

20 yes, there are new requirements put in place, but 

21 the fundamental backbone to what's trying to be 

22 achieved in low-level waste disposal is still there 

23 in the existing Part 61, and in the proposed one. 

24 The one area where it's different, and I would say 

25 is the most significant area, is in the area of 
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1 requiring the intruder assessment.

2 When the existing Part 61 was 

3 developed, the intruder was protected by the 

4 regulator doing an analysis of what waste they 

5 thought would go in the facilities in the future, 

6 and then doing -- basically we call it a back 

7 calculation to determine what concentrations would 

8 result in the impact they were trying to protect 

9 people to.

10 Those concentrations are what are shown 

11 in Table 1 and Table 2 of the regulation. The 

12 existing regulation says protect the intruder at 

13 all times in the future, but the way that you do 

14 that is by showing that the waste meets Table 1 and 

15 Table 2. It also has other requirements associated 

16 to intruder barriers and depth of the waste that 

17 you must meet. That's the area where I would more 

18 agree with you that you could say that the target 

19 was shifted because you're now requiring an 

20 analyses, but in our -- in practical application of 

21 that, three of the four existing sites have already 

22 done an intruder analysis. It's only one out of 

23 the four that didn't do the intruder analysis. The 

24 majority of them have.

25 MEMBER BROWN: Thank you.
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1 MS. LONDON: This is Lisa London from 

2 OGC. I just wanted to highlight a couple of points 

3 that Dave made that I think it's really important 

4 -- key take-away points. That is that the 

5 performance objectives in Part 61 always have to be 

6 complied with. That was always the case. If a 

7 site had reached its closure point ten years ago, 

8 it would be incumbent upon them to be able to 

9 demonstrate compliance with the performance 

10 objectives.

11 These rule revisions are not imposing 

12 anything that says -- we're simply not requiring 

13 anything to be dug up. You're not going to find 

14 anything in the rule that requires that. It's 

15 incumbent upon the licensee to propose how they 

16 would want to approach dealing with a situation if 

17 they were to determine they would not be able to 

18 meet the performance objective. We're not 

19 requiring anything to be dug up. Just wanted to 

20 make sure -- because as Dave noted, this has come 

21 up numerous times. I think it's really important 

22 that we stress that we are not requiring anything 

23 to be dug up. It will be incumbent upon the 

24 licensee to propose how they solve a problem.

25 MEMBER BROWN: Yes, but that's kind of 
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1 -- you're not requiring it, but in order to be --

2 they're going to evaluate, and in order to comply, 

3 they might have to dig it up. (Simultaneous 

4 speaking) you're not requiring it, but it's a 

5 backdoor way of they're required to be doing 

6 something.

7 I'm not saying it's not right or wrong. 

8 I just wanted to make sure I understood what you're 

9 doing in here. I'm talking about while you're 

10 active right now. He already went over the 

11 post-closure part, that there's an institutional 

12 period. I'm not quite sure what happens there, but 

13 then the post-institutional period is another set 

14 of things you deal with.

15 It was while you're still -- you've got 

16 stuff you put in, site's active, now you put more 

17 stuff in, has to meet the new. Now how do they 

18 have to evaluate that for compliance and go back? 

19 You say you're not requiring digging up, but, in 

20 fact, the only way to comply may be to dig it up, 

21 in which case, then you go through the rest of the 

22 risk assessments, the dose assessments, etc. 

23 Where's the rational person that sits down -- I 

24 could use where's the adult in the room that says, 

25 "No, we're stopping right here because it's just 
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1 not clear that the balance is not met"? It's just 

2 hard. Maybe the state -- should the state be in 

3 charge of that, as opposed to the NRC regulations, 

4 or what? It just seems to be a little bit open.

5 MS. LONDON: I wanted to make sure 

6 everyone understood that the requirement to comply 

7 with the performance objectives, those were always 

8 there. At closure, that's something -- the site 

9 would have always had to demonstrate. If we had 

10 never done these rule requirements, they may have 

11 still gotten to that point where at closure, they 

12 couldn't demonstrate compliance with the 

13 performance objectives. Then they would have had a 

14 problem.

15 MEMBER BROWN: Based on some of the 

16 stuff they have to look at now, that's not 

17 overwhelmingly obvious to me, but I understand your 

18 point, or what you said, thank you.

19 MR. ESH: Next slide, Gary. Probably 

20 one of the most challenging issues in this process 

21 was the issue of the analysis time frames. This 

22 figure is designed to give you an overview of the 

23 variety of time frames that are in the regulation. 

24 The second and third line down are really the only 

25 new parts in the regulation. The top line and the 
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1 three below that are all existing in the 

2 regulation. Each of these time frames has a basis 

3 for how they've been placed in the regulation and 

4 the purpose of them.

5 For instance, in the area of site 

6 characteristics, this is our representation for the 

7 guidance document on how to look at the site 

8 characteristics because the regulation in 61.7 says 

9 that you should consider site characteristics for 

10 500 years or the indefinite future, I think, is the 

11 language that's in the existing regulation.

12 How long is the indefinite future? 

13 What we said in our guidance document is that you 

14 should generally be looking at the site 

15 characteristics commensurate with the type of waste 

16 that you're trying to dispose. If you have -- if 

17 you're in the situation that you have -- you don't 

18 have significant quantities of long-lived waste, 

19 then a 500-year to 1,000-year type of time frame is 

20 appropriate.

21 If you're in the situation where you do 

22 have significant quantities of long-lived 

23 radioactivity, then you should look at your site 

24 characteristics commensurate with how long you're 

25 trying to evaluate the problem for. The ones that 
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1 I'll focus on, though, are the ones that are 

2 different here. We can talk about the other ones 

3 if you have questions, but the compliance period 

4 and the performance period. We understand -- and 

5 we looked at them carefully -- the ACRS's positions 

6 on this topic, both the recent ones and the ones in 

7 the very distant past.

8 This issue has been discussed even back 

9 in the 1990s because the NRC was developing a 

10 guidance document for 10 C.F.R. Part 61, how to do 

11 the performance assessment analyses. One of the 

12 issues that they tackled was the compliance period. 

13 They had interactions with the ACRS, the staff, at 

14 that time, in the 1990s, and the ACRS wrote various 

15 letters on that topic then. We considered those, 

16 too, when we developed our approach. There's a lot 

17 of confusion on time frames.

18 One other thing we saw in the comments 

19 from various stakeholders is that the compliance 

20 period in Part 61 is 500 years. That is not 

21 correct. Part 61 is silent on what the compliance 

22 period is. For 61.42, it says, "Intruder must be 

23 protected for any time in the future." That's the 

24 existing regulation; that's what it says with

25 respect to compliance period and time frames. We 
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1 only added or altered, really, the compliance 

2 period and the performance period. Next slide, 

3 please. As we talked about earlier, all of our 

4 existing facilities are in agreement states. We 

5 took that into consideration as we developed the 

6 approach for time frames and how we tried to solve 

7 this problem. Throughout the process, we've had 

8 significant interest in the topic.

9 We received significant comments, and 

10 we devoted significant effort to formulation of the 

11 final position. As Gary described earlier, the key 

12 features of the final position is a compliance 

13 period of 1,000 years or 10,000 years, depending on 

14 if the site will contain significant quantities of 

15 long-lived radionuclides. Then the performance 

16 period only applies if you're using the compliance 

17 period of 10,000 years.

18 So long-lived waste, you're looking at 

19 10,000 years, plus the performance period. 

20 Insignificant quantities of long-lived waste, 

21 you're going to be using 1,000-year compliance 

22 period. For a low-risk problem, we would be in 

23 alignment with what we do in 10 C.F.R. Part 20 for 

24 decommissioning, or what the Department of Energy 

25 does in their analyses. The other important factor 
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1 here is that, as Gary discussed, the Compatibility 

2 Criteria C. Agreement states can be more 

3 restrictive if they choose to. That's one of the 

4 consistent comments that we received in this 

5 process from the agreement states. All four of the 

6 existing agreement states currently use a 

7 compliance period longer than 1,000 years.

8 The only unique case is for Utah, that 

9 has this distinction between large quantities of 

10 uranium and traditional waste, where they say use 

11 10,000 years, plus look longer for the large 

12 quantities of uranium because they were trying to 

13 come up with criteria that they thought were 

14 appropriate for depleted uranium.

15 Our rulemaking, though, was a little 

16 more broad than just depleted uranium. We were 

17 also tasked with looking at blended waste, and we 

18 had to consider the potential for new waste streams 

19 to come into play in the future. Because the 

20 existing regulation, especially with the 61.42 

21 requirements, are based on assumed quantities and 

22 concentrations of waste.

23 If you've done an inverse calculation 

24 to develop what the concentrations are that you 

25 need to use to demonstrate compliance with 61.42, 
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1 if you change your waste, then what does that mean 

2 for those concentrations that you calculated? The 

3 concentrations that you may need as limits can be 

4 quite a bit different if you change your waste. We 

5 did not want to be in the situation, after eight or 

6 nine years, of somebody coming in with a new waste 

7 stream, and we would need to turn around and say, 

8 "Now we need to go through this process again to 

9 look at the new waste stream that may have 

10 developed, that we need new criteria for. We 

11 wanted something that would work, no matter what 

12 the waste streams are, that somebody could do the 

13 analyses and demonstrate compliance with it.

14 MEMBER REMPE: David, I'm a bit slow. 

15 Tell me again what Utah does, and they did it

16 because of -- expound a bit about their reasoning 

17 for doing something different there.

18 MR. ESH: They make a distinction --

19 they originally had analyzed 500 years. They used 

20 500 years as a compliance period for evaluation of 

21 their low-level waste facility. There's members in 

22 the audience here that can correct me if I get 

23 anything wrong on this.

24 Part of the reason for that was their 

25 site, they believe, has ground water that's not 
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1 potable. It eliminates a large part of the 

2 analyses that you commonly look at in a low-level 

3 waste facility. I would say if you're trying to 

4 site a facility, that's a great idea. If you put 

5 it someplace where somebody's not likely to use the 

6 water, you would want to take advantage of that. 

7 But then the licensee proposed one of the entities 

8 to take some of the large, significant quantities 

9 of depleted uranium. They said, "Okay, that raises 

10 some unique issues for us.

11 What may we need to do differently to 

12 regulate that material, as opposed to this 

13 traditional material that doesn't behave like 

14 that?" They went through a rulemaking process and 

15 developed criteria for -- I don't know the specific 

16 language they used, but basically, large quantities 

17 of uranium, they use a different compliance period 

18 for that compared to other waste.

19 MEMBER REMPE: That period is?

20 MR. ESH: They use 10,000 years for 

21 that, and then they look longer. They have 

22 something similar to what we're calling our 

23 performance period here. They have that in their 

24 regulations.

25 MEMBER REMPE: Thank you.
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1 MR. ESH: Let's see if I had anything 

2 else I wanted to say on here. All our agreement 

3 states have been licensed and are operating. All 

4 of them have used a compliance period longer than 

5 1,000 years. One of the arguments we heard from 

6 some of the stakeholders is using a 10,000-year 

7 compliance period is going to make these facilities 

8 unlicenseable, and it's going to create a huge 

9 burden for them to be licensed. All our facilities 

10 already use values longer than 1,000, and they are 

11 licensed and operating.

12 To me, that's factual information that 

13 demonstrates that position was not entirely 

14 correct. We also discussed with a variety of the 

15 contractors that developed the performance 

16 assessments -- because I had an opinion that if you 

17 have a site that might be stressed by some unique 

18 processes or events in the future that occur, say, 

19 with a frequency that they're likely to occur after 

20 1,000 years, but not really likely to occur within 

21 1,000 years, then that would be a situation where 

22 maybe you can have some additional burden in your 

23 licensing.

24 Because maybe you're worried about a 

25 seismic event, for instance. That's not a good one 
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1 for waste disposal, but it's just the one I'll use 

2 for an example. Maybe you're worried about a 

3 seismic event that could damage or stress your 

4 facility. That could introduce burden if you're 

5 doing a 10,000-year analysis, compared to 1,000, 

6 because maybe it's at low enough frequency you 

7 don't expect it to occur with a frequency to affect 

8 your 1,000-year analysis. But in the vast 

9 propensity of cases, what you have to do to develop 

10 a 1,000-year analysis, a performance assessment, 

11 intruder assessment, etc., a huge part of that 

12 effort is the same for the 10,000-year analysis. 

13 It's not a significant increase in effort to go 

14 from the 1,000 year to the 10,000 year.

15 You have to develop the models. You 

16 have to develop all the data for it. You have to 

17 write all the reports, all that sort of stuff you 

18 have to do for the 1,000-year analysis. This idea 

19 that the 10,000-year analysis is significantly more 

20 burdensome I don't believe is true. It wasn't true 

21 from our experience, and then it also wasn't true 

22 when we talked to the various contractors on the 

23 private side that developed the models. They said 

24 no, the additional burden for the 10,000-year 

25 analysis, compared to the 1,000, is not significant 
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1 to them.

2 CHAIR CHU: David, I do want you to 

3 comment on something. I agree with you on the 

4 extra burden between 1,000 to 10,000 is not that 

5 much more, but a lot of people comment on the fact 

6 that because the uncertainty increases as time goes 

7 on, your answer is not credible.

8 MR. ESH: Right.

9 CHAIR CHU: So would you --

10 MR. ESH: Right --

11 CHAIR CHU: -- here --

12 MR. ESH: Yes, that's -- that's another 

13 argument that we heard, and -- and I think that 

14 creates a -- in my opinion, a policy challenge 

15 associated with the uncertainty, and where I would 

16 go with that is so the argument that was put forth 

17 is the uncertainty is increasing, okay, in some 

18 cases it is, and in some cases it is not. 

19 You know, we looked at the uncertainty 

20 and different sources of uncertainty when we did 

21 our white paper, and our opinion was basically that 

22 the socioeconomic source of uncertainty is much 

23 much larger than many of the other sources of 

24 uncertainty associated with like flow and transport 

25 and, you know, all the -- all the gs that go into a 
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1 performance assessment because, if you think about 

2 how the world has changed in the last even 100 

3 years, you know, and I like to use -- I like to use 

4 the Las Vegas argument.

5 So the argument I would make is if you 

6 could go back in time say 300 years and talk to 

7 somebody living in the environs of where Las Vegas 

8 is today and ask them what Las Vegas was going to 

9 look like 300 years from then, they would not have 

10 predicted what they got. They would have been 

11 probably way off on that estimate, and that is the 

12 type of uncertainty you're dealing with on the --

13 on the -- the human side of it.

14 And one way we try to manage that in 

15 the regulatory process is we say, use some fairly 

16 conservative receptors that are representative of 

17 what people might try to do today and just 

18 eliminate that source of uncertainty that does not 

19 do you any good to speculate about exactly what 

20 somebody is doing, but if you want to refine your 

21 receptor scenario and say, well, today, we have 

22 nobody living there, and we have hunters that spend 

23 five hours a day there, well then in the future, 

24 if, you know, they hit a gold rush of the next 

25 natural resource in that environs and they -- say, 
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1 for instance, fracking.

2 I think fracking is a great example, 

3 too, you know. 50 years ago, fracking wasn't so 

4 widely done, if at all, but now, fracking is pretty 

5 prevalent. So if you did an assessment 50 years 

6 ago and said, you know, what's the likelihood of 

7 somebody drilling in my facility, well, fracking 

8 wouldn't have been part of the consideration, but 

9 today, if you're in West Texas or at WIPP, or, you 

10 know, some other -- even Western New York, it's a 

11 consideration for all of those places.

12 So anyway, I am sorry I am rambling a 

13 bit, but the uncertainty piece is an important 

14 consideration, but I think the policy challenge is 

15 I don't -- I am not aware of other areas in the 

16 NRC, or even in risk management in general, that 

17 use the argument of the uncertainty is so large, 

18 therefore I should reduce my requirements, which is

19 basically the argument that is put forth, okay? So 

20 if you're saying, well, the uncertainty is so large 

21 with 10,000 years, therefore I should make it 

22 1,000, I don't know. I think from a policy 

23 standpoint, that is difficult.

24 You know, think about in everyday 

25 experience what you would do. If I was going out 
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1 and trying to cross Rockville Pike and there was a 

2 big truck parked there, I would not just start 

3 walking, you know? I would try to do something to 

4 mitigate my risk or mitigate my uncertainty 

5 associated with the decision I was trying to make. 

6 I think the same thing should apply here in the 

7 waste disposal areas, that you should be doing 

8 things -- if you truly think the uncertainty is 

9 prohibitive, then you should not be taking that 

10 action, you should be taking some other action 

11 where you can understand the uncertainty and you 

12 can uncertainty the risks associated with it.

13 I personally do not believe that those 

14 uncertainties are prohibitive in these 

15 calculations. I think they serve a very good 

16 purpose. They communicate to the best of our 

17 ability how we expect things to behave in the 

18 future, and they are useful for making regulatory 

19 decisions, which is what you are trying to do.

20 Part of the problem in waste disposal 

21 is that the risk gets liberally applied throughout 

22 the vernacular, but in many cases, we aren't 

23 necessarily talking truly about risk. We are 

24 talking about radiological dose, which might be 

25 different, especially considering what you're doing 
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1 to get from Point A to Point B in that calculation, 

2 so it's kind of a long answer to your question 

3 about uncertainty, but I think fundamentally, I 

4 don't agree with the idea that if the uncertainties 

5 are prohibitive, you should reduce your 

6 requirements. I think it means you should solve 

7 the problem a different way, or you need some 

8 different requirements --

9 CHAIR CHU: Thank you.

10 MR. ESH: -- not -- not that you should 

11 -- not that you should lessen them. 

12 MEMBER REMPE: To belabor it, I think 

13 this is a good time to re-ask my question about the 

14 international community because I think the same 

15 situation occurs, even if they go to 50,000, 

16 they've got to deal with uncertainties for that 

17 period, and do they treat it the same way? They 

18 basically --

19 MR. ESH: Right.

20 MEMBER REMPE: -- don't try and -- they 

21 use the conditions the way it is today, and they 

22 run their calculation out for 50,000 years instead 

23 of 1,000, or something like that.

24 MR. ESH: Right. Internationally, they 

25 will take a variety of approaches. Some of them 
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1 say for like -- I know some countries even for like 

2 chemical waste disposal, their requirements is they 

3 analyze to peak, whenever that might be. It might 

4 be five million years that they analyze for, and so 

5 they are talking about uncertainties that are quite 

6 significant compared to what we're talking about.

7 But they -- especially in Europe, I 

8 would say, the people are much more comfortable 

9 with this idea of longer time frames, and partly 

10 because they've been around -- they have been there 

11 longer, and you'll talk to people who their family 

12 may have lived in the same town for like 700 years, 

13 and for us, we're kind of an infant compared to 

14 that in terms of a country and our development and 

15 everything, so part of that cultural idea reflects 

16 -- or comes into play.

17 But then in many cases in the 

18 international space, they will set a limit for what 

19 they think is appropriate for near-surface 

20 disposal, and it might be a -- a general limit of, 

21 you know, x becquerels per kilogram of long-lived 

22 alpha. Once you have set that limit, that is their 

23 way of mitigating the uncertainty associated with 

24 the longer time frames.

25 If you have limited how much of the 
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1 long-lived material can go in the near-surface, 

2 then you can use a much shorter compliance period 

3 because you have restricted what the risk may be at 

4 a longer time by prohibiting that material from 

5 going there. So that is -- you see that quite 

6 commonly in a lot of the other programs, is they 

7 will set some sort of waste limit that is separate 

8 from the technical analyses.

9 And here, in the U.S. and in this 

10 rulemaking, we're trying to strive for a much more 

11 site-specific analysis-based approach, and so you 

12 could set some sort of similar concentration limit, 

13 say, for uranium. In fact, limits for uranium were 

14 calculated in the original regulation, in the draft 

15 regulation for 10 CFR Part 61. But between the 

16 draft and the final, they decided that there wasn't 

17 going to be much uranium that was going to be 

18 disposed in a commercial low-level waste disposal 

19 facility.

20 Well, that looks like that was a bad 

21 assumption today, but the limits that they 

22 calculated were a very small fraction of the 

23 concentrations of the depleted uranium that you're 

24 -- that you're dealing with, so they did generate 

25 some -- they -- we, being the NRC, we generated 
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1 values for say concentration limits for uranium. 

2 That option was proposed to the Commission during 

3 the early stages of this process, and they didn't 

4 adopt that approach. They decided, no, the 

5 site-specific analysis approach was the better way 

6 to go because you can do it in a more risk-informed 

7 manner. You can reflect the actual say 

8 radiological dose impacts at the site rather than 

9 some hypothetical calculation that the regulator 

10 would do.

11 So that -- that option was provided to 

12 the regulator of how to -- how to -- it was 

13 provided to the Commission of how to manage 

14 uncertainties, and they adopted the approach we're 

15 talking about here.

16 MEMBER REMPE: I am a little confused 

17 because I thought earlier, you told me -- told us 

18 that the international community actually was 

19 amazed the U.S. is only thinking of up to 10,000 

20 years, they went further overseas --

21 MR. ESH: Right.

22 MEMBER REMPE: -- to longer time 

23 periods.

24 MR. ESH: Right. The ones that do not 

25 set some sort of limit --
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1 MEMBER REMPE: Go for longer time 

2 periods --

3 MR. ESH: -- generally, they just

4 analyze out for much longer time frames.

5 MEMBER REMPE: And for uncertainties, 

6 basically, no, they don't try and think about 

7 uncertainties and differences in seismic or weather 

8 changes, they take the conditions the way they are 

9 today and do some uncertainties, but they run the 

10 calculation longer --

11 MR. ESH: Well --

12 MEMBER REMPE: -- is that the answer?

13 MR. ESH: No, I would not generalize 

14 like that, and if I gave you that impression, it is 

15 incorrect.

16 They -- it can vary from program to 

17 program, but generally, any of these that are doing 

18 the technical analyses, they are trying to do the 

19 best estimate they can of the expected performance 

20 in the future, so if they believe -- many of them 

21 will -- will look into climate change --

22 MEMBER REMPE: Okay. 

23 MR. ESH: -- for instance. We say look 

24 at natural cycling of the climate, but that 

25 anthropogenic climate change, who knows where it's 
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1 going to end up and how exactly you should assess 

2 it. That is kind of a, okay, if it does in fact 

3 need to be revisited in the future, we will revisit 

4 that aspect of the assessment, but by considering 

5 natural cycling of the climate, you should be 

6 encompassing most of the effects of the 

7 anthropogenic changes in the climate because the 

8 natural cycling of the climate from the planetary 

9 motions and everything is so large, you know, you 

10 get glaciation and that sort of thing eventually at 

11 some locations.

12 But the -- the anthropogenic changes 

13 will occur earlier, but right now, it does not -- I 

14 would not say that they are going to cause effects 

15 on the order of the planetary motion types of 

16 effects from the climate cycle.

17 So anyway, internationally, though, 

18 they do consider all those sorts of process --

19 features, events, and processes in their analyses, 

20 but it can vary substantially from program to 

21 program. So some of them are much more mature than 

22 others, and some are earlier in their development 

23 in terms of the complexity of their technical 

24 analyses. 

25 MEMBER REMPE: Okay. 
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1 CHAIR CHU: Dave, a lot of what you 

2 describe on how to, you know, apply the FEPs and 

3 all that, is it in the guidance document? Are all 

4 these things --

5 MR. ESH: Right. So in the guidance 

6 document in Chapter 2 is where we go through a 

7 process of how to develop the scope of your 

8 analyses, so what should be in it, and what should 

9 be out of it, and there's kind of two approaches, 

10 either top-down or bottom-up.

11 And one is based on identifying the 

12 safety factors or safety functions of your system 

13 and then building kind of the processes and events 

14 that may affect those safety functions, so that is 

15 pretty much the top-down. The bottom up is you 

16 start with a database or a list of all the 

17 features, events, and processes that you could 

18 anticipate at any site, and then you determine the 

19 subset of those that may apply to your particular 

20 site, and then you go through a process of taking a 

21 subset of those to develop into your models to 

22 evaluate your particular site.

23 So it is -- it is pretty lengthy, 

24 though, that part on the -- the FEP process, so 

25 I'll warn you ahead of time. Let's see, where were 
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1 we here on time frames? I think we can go to the 

2 next slide.

3 Also, one other thing on the time 

4 frames, the -- it isn't just in the Agreement State 

5 space that these 10,000 year analyses were used. I 

6 think this was a question earlier, but the 

7 Department of Energy has used the 10,000 year 

8 analyses in a variety of decisions that have been 

9 made, so in their incidental waste determinations 

10 for the Saltstone Disposal Facility at the Savannah 

11 River Site, for tank closure at the Savannah River 

12 Site, for tank closure at Idaho, at Idaho National 

13 Laboratory, and in process for tank closure at the 

14 Hanford site, all of those sites have analyzed --

15 or done 10,000 year analyses for those various 

16 decisions.

17 And the incidental waste problem is one 

18 where it is material that had resulted from the 

19 weapons program, basically, and some of the 

20 material that -- the residuals that remains in the 

21 system, if you went strictly by definition, it 

22 would be high-level waste because in the U.S., 

23 we're not very smart with how we define our waste 

24 classes, and Lisa will smack me for this, but they 

25 are based on words in legal definitions instead of 
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1 by necessarily engineering and that sort of thing.

2 So yeah, so the problem is that some of 

3 that material by definition could be considered 

4 high-level waste, but then the Department of Energy 

5 goes through this waste incidental processing, 

6 waste determination process to determine that some 

7 of it could be managed as -- with -- as low-level 

8 waste, or similar to low-level waste, and for the 

9 Savannah River Site and Idaho, they used the 

10 criteria in 10 CFR Part 61. 

11 That material is much more similar to 

12 kind of the situation for some unique waste streams 

13 where you have long-lived -- significant amounts of 

14 long-lived radioactivity than it is most of the 

15 traditional commercial low-level waste, so it makes 

16 sense to use that there, and with our proposed 

17 requirements, I think -- I can't guess how it would 

18 fall out, but my guess is they would continue to be 

19 using the 10,000 year evaluation for those 

20 incidental waste determinations, but there may be 

21 situations in DOE's inventory in waste where they 

22 could determine if it were incidental waste that it 

23 does not have significant quantities of long-lived 

24 radionuclides, and then they would use 1,000 year 

25 analyses.
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1 So that's another data point of you had 

2 asked about, you know, numbers and who uses what. 

3 Maybe it was over here, I think you asked numbers 

4 and who uses what, so let's see here.

5 Significant quantities, so the way this 

6 approach is set up now is that you determine your 

7 compliance period based on if you have significant 

8 quantities of long-lived radionuclides, and how 

9 does one determine though if you have them? And 

10 what we're advocating is that you start simple and 

11 introduce more complexity to make this decision if 

12 necessary.

13 So the simplest approach is to look at 

14 your inventory. The inventory is the thing you 

15 know best in -- in probably this performance 

16 assessment process. Even the inventory has 

17 uncertainties, but you know what you want to put 

18 into the system, so you can design a disposal 

19 facility with say minimal long-term barriers 

20 because you only want to take short-lived waste. 

21 That would be smart. I would do that as an 

22 engineer.

23 If I was trying to dispose of 

24 long-lived waste, I would design a much different 

25 facility than if I am trying to take short-lived 
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1 waste. So we thought, well, can't we structure 

2 this analyses to kind of go in that same direction? 

3 And in the -- the previous -- the most recent ACRS 

4 letter that we received, they said -- or you said 

5 use a site-specific approach, don't define the 

6 period of performance or compliance period in the 

7 regulation.

8 So the challenge we faced was, though, 

9 that many stakeholders had told us to define the 

10 compliance period or the performance period --

11 period analyses in the regulation. We heard that 

12 early on in the process when we had workshops in 

13 2009. They said yes, yes, yes, we all want a 

14 number in the regulation. Of course, nobody can 

15 agree with each other, but they all wanted a number 

16 in there.

17 So -- so we -- you know, we listened to 

18 you, and we know the existing regulation has --

19 does not have a compliance period in it, and as I 

20 stated earlier, originally, that did result in a 

21 pretty big variance in the values that people used. 

22 The other challenge with not putting a 

23 number in there, but doing it purely based on a 

24 site-specific analysis, is we think there could be 

25 negative incentives from a policy standpoint. So 
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1 if you have a very good site, then maybe your peak 

2 dose is not until 100,000 years or longer. So --

3 and then say if you had an underperforming site or 

4 a poor site, maybe your peak dose happens in 500 

5 years. So should the poor site only need to 

6 analyze 500 years while the good site needs to 

7 analyze 100,000 years? That -- I mean, in my mind,

8 it probably should be the other way around, as you 

9 want to have more confidence in what is going on 

10 with the poor site, and you can -- you can -- can 

11 rely on simpler analysis for the better site.

12 So without defining the period of 

13 performance, we kind of -- and -- we thought you 

14 could run into that, and the practical experience 

15 from what has happened in our Agreement States 

16 looks like that kind of is the fact. So like 

17 Texas, that has a very robust site and, whether you 

18 believe their calculations about infiltration rates 

19 and that sort of thing, potentially very long 

20 travel times, or even no travel times to -- to 

21 groundwater, that was a site that analyzed the 

22 longest.

23 And so we didn't want to have that 

24 disincentive to choosing good sites because if 

25 you're going to raise this argument that it is 
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1 extremely burdensome to do the long-term analyses, 

2 and it causes me all sorts of problems, well then 

3 why would you ever choose a good site that is going 

4 to force you to do this long analyses with this 

5 burden and all these problems? As an engineer, I 

6 would choose the one that I think is a lot easier, 

7 which would be the poorer-performing site.

8 So we -- we talked about that and tried 

9 to say, well, we think we need to put some numbers 

10 in here, but then if we're smart about it, we can 

11 do the part which you also wanted, which was to 

12 make it basically site-specific, so we started off 

13 and we said, okay, this is going to be 

14 waste-specific, but then maybe you look at 

15 inventory and you say gee, based on my inventory, 

16 I'm not sure whether I have significant quantities 

17 or not. Well then, you do site-specific screening 

18 analysis and see, okay, based on my physics and 

19 chemistry of my site, is the amount of inventory 

20 that I have likely to cause me a long-term problem 

21 or not?

22 So that's another way, as you step 

23 through this process, of defining whether you have 

24 significant quantities or not, is to consider the 

25 actual site-specific characteristics or do a full 
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1 site-specific analysis as indicated in number 3 

2 here on a case-by-case basis, but the -- what I 

3 would say, though, is if you're needing to get into 

4 this really complicated argument for why you're 

5 doing 1,000 years, you should probably just be 

6 doing the 10,000 years because that means that 

7 you're in such an area that you're going to ask for 

8 all sorts of problems associated with if you 

9 truncate the analysis, especially if the impacts 

10 are much bigger after 1,000 years, kind of like 

11 your example, Dr. Chu, with the depleted uranium.

12 If you're really worried about managing 

13 the material, I think you'd want to know what is 

14 going on throughout the whole hazard profile of the 

15 material. You might make different decisions as to 

16 how you design your facility and how you make your 

17 arguments about protecting health and safety, but 

18 you definitely want to know what is going on for 

19 the waste that you're disposing of, you know, 

20 irrespective of what the regulatory requirements 

21 might be.

22 And so this approach with the -- kind 

23 of looking at the inventory, looking at the 

24 simplified dose assessment and then maybe doing 

25 some more complicated we feel is going to allow 
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1 people to do -- to tailor the analyses based on the 

2 waste that they have and to make smart decisions 

3 and make sure that the analysis is appropriate for 

4 the material and the site that they're analyzing. 

5 It doesn't get all the way where you would 

6 recommend it in your letter of don't define it at 

7 all in the regulation, but as I explained, there 

8 are reasons why we felt we could not do that. So 

9 next slide, please, Gary.

10 Here is an example that's similar to 

11 what is in the guidance, not identical, and I'm not 

12 necessarily going to go through this in detail 

13 here, but it's there in your slides, you can look 

14 at it, and we can -- you can ask about it, we can 

15 talk about it if you'd like --

16 MEMBER BROWN: What's SOF?

17 MR. ESH: SOF is the sum of fractions.

18 MEMBER BROWN: Okay. 

19 MR. ESH: So yeah.

20 MEMBER BROWN: Thank you.

21 MR. ESH: So yeah, so in the -- in the 

22 context of the -- of where this came from, that 

23 would make sense. I see now that that is not 

24 identified in the example. It's a little hard to 

25 understand. But so in -- in low-level waste, when 
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1 you have a mixture of radionuclides, when you 

2 compare each radionuclide to its concentration 

3 limit to get -- you get a fractional value, and 

4 then you sum all those up, and that is called the 

5 sum of fractions, right, okay. All right, all 

6 right. 

7 You can just tell me to shut up if I am 

8 --

9 MEMBER BROWN: No, no.

10 (Simultaneous speaking.)

11 MEMBER BROWN: -- Charlie Brown. 

12 (Laughter.)

13 MR. ESH: The performance assessment is

14 one of the main components of the technical 

15 analysis that you use in the 10 CFR Part 61. It is 

16 not a new requirement, though. The existing 10 CFR 

17 Part 61 has requirements for technical analyses. 

18 The words are different, the analyses is 

19 essentially the same.

20 So the existing analyses in Part 61 for 

21 demonstration of compliance with 10 CFR 61.41 is a 

22 performance assessment. This is just modernizing 

23 the terminology because in 1982, they didn't call 

24 it performance assessment, now we do. The 

25 definition that is shown up here, though, 
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1 basically, you identify the features, events, and 

2 processes that could affect the disposal site 

3 performance, so that's getting the scope of the 

4 analyses correct, and then you estimate the impacts 

5 associated with those, including the uncertainties. 

6 Some of the new requirements under 

7 61.13 that support the performance objective are 

8 new, but I will talk about those on the -- on the 

9 next slide or the slide after. Those requirements 

10 are we believe implicit in the existing regulation. 

11 They're kind of mom and apple pie things when it 

12 comes to performance assessment, so you need to 

13 have support for your calculations, you need to get 

14 the scope right, you should consider uncertainty 

15 and variability. Those are all things that the 

16 modern technical analyses should do, and so we 

17 don't believe those are burdensome. 

18 Even if they're not listed in the 

19 regulation, if a performance assessment came in to 

20 me at NRC that wasn't being done under an Agreement 

21 State and it was lacking on any one of those 

22 things, they would be getting lots of RAIs on it, 

23 and maybe I wouldn't approve their application, 

24 because those are fundamental components of the 

25 performance assessment, and they aren't necessarily 
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1 -- well, they can involve effort, so -- but they 

2 should be part of any performance assessment, 

3 existing or in the future.

4 There is a requirement to update the 

5 performance assessment enclosure. That is an 

6 important requirement because, as Gary indicated, 

7 or was indicated previously, some of these 

8 facilities may operate for a substantial period of 

9 time, 50, 60 years. A lot of things can change in 

10 50 or 60 years: our knowledge about various 

11 scientific and technical things, the -- what's 

12 going on socioeconomically in the environment of 

13 the disposal facility, so the requirement to update 

14 the performance assessment at closure is good 

15 science, and we think it is good policy because 

16 when you get to the point of closing the facility 

17 and the pass-off occurs from the licensee to the 

18 entity that is going to be doing the institutional 

19 control, they want to have confidence that the 

20 facility is going to continue to meet the 

21 requirements.

22 So without updating the performance 

23 assessment, there -- there may be some questions 

24 about that. If the licensee was smart and 

25 introduced significant margin or enough margin in 
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1 their analyses when they did their initial 

2 licensing basis, then the amount of updating that 

3 they might need to do at closure could be minimal, 

4 so they could make the argument that I've already 

5 accounted for everything that we observed in this 

6 time period while we operated.

7 The other thing in the performance 

8 assessment area is that we modified the siting 

9 characteristics, consistent with the disposal of 

10 long-lived waste. So this one is a little bit 

11 tricky if you're not familiar with Part 61. The 

12 siting characteristics are in 61.50, and they have 

13 -- there's requirements in there that are 

14 exclusionary or need to be present for a site, and 

15 they don't indicate basically the time frame that 

16 you're talking about that that characteristic might 

17 need to be present or need to be excluded.

18 So an example would be the facility 

19 cannot be located in a 100 year flood plain, okay? 

20 So what is the 100 year flood plain now? What is 

21 the 100 year flood plain 1,000 years from now? 

22 Those can be different answers, and the one is much 

23 harder to estimate than the other. You can do a 

24 pretty good job estimating the 100 year flood plain 

25 today; much more challenging to estimate the 100 
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1 year flood plain 1,000 years from now.

2 So we looked at that and said, okay, 

3 Part 61 when it was developed with the waste tables 

4 and these other criteria were envisioning not 

5 significant quantities of long-lived waste, but 

6 they were looking at mainly short-lived activity 

7 that would make sense to say, okay, you don't want 

8 to put the facility in a 100 year flood plain where 

9 it's flooding today because if it's flooding today, 

10 you're likely to have a lot of instability 

11 tomorrow.

12 So -- but the idea is that at longer 

13 time periods, when the short-lived activity, which 

14 you can only tolerate a small amount of that 

15 getting into the environment, has decayed away, the 

16 long-lived activity, then you can use a what we 

17 would call risk-informed performance-based approach 

18 to consider those siting characteristics, and what 

19 that means is whether you can meet the 61.41 or 42 

20 performance objectives.

21 So for the first 500 years, we stuck 

22 with the language in Part 61 that says, for 

23 instance, you can't cite a facility in a 100 year 

24 flood plain. After 500 years, if you have a 100 

25 year flood plain or you project that you're going 
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1 to have flooding in that area, then you can look at 

2 it in terms of whether it impacts the performance 

3 objectives or not. 

4 Otherwise, say there's a requirement in 

5 there like the waste can't be disposed in the zone 

6 of water table fluctuation. Well, if you applied 

7 that for 10,000 years, you would have to look at, 

8 well, can I demonstrate that this waste is never 

9 going to be in the zone of water table fluctuation 

10 for the next 10,000 years? That seems to be an 

11 intractable problem technically. But you can 

12 probably better estimate if it does fluctuate, 

13 what's the impacts that I might see from it, so the 

14 modified siting characteristics, that's how we went 

15 about it. Next slide, please. 

16 MEMBER KIRCHNER: May I ask just a 

17 question of clarification? So you have 500 years 

18 for the site characteristics versus 1,000 years for 

19 the compliance period, so how do you reconcile 

20 those?

21 MR. ESH: Yeah, the site 

22 characteristics language is existing in the 

23 regulation. It says consider the site 

24 characteristics for 500 years or the indefinite 

25 future. I don't remember, let me get the language 
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1 straight for you here.

2 So, okay, here, it is "In choosing a 

3 disposal site, site characteristics should be 

4 considered in terms of the indefinite future and 

5 evaluated for at least a 500 year time frame," so 

6 at least a 500 year time frame. If you evaluated 

7 the site characteristics for 500 years and you're 

8 analyzing for 1,000 --

9 MEMBER KIRCHNER: Yes.

10 MR. ESH: -- you're not going to be --

11 something is not going to occur -- like with 

12 confidence, you're not going to be able to say 

13 something occurs in the 500 to 1,000 year time 

14 frame that is significant that you couldn't also 

15 argue should be part of the site characteristics 

16 you consider in the 0 to 500. Now as long as 

17 you're in the same ballpark of what you're 

18 analyzing, I think that is what we're trying to 

19 achieve.

20 Since the regulatory language is pretty 

21 broad in how it could be interpreted, then we chose 

22 to address that in the guidance of how to -- how to 

23 consider the site --

24 MEMBER KIRCHNER: So you didn't --

25 MR. ESH: -- characteristics. 
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1 MEMBER KIRCHNER: -- go back and change 

2 it from 500 to 1,000?

3 MR. ESH: No. I think we still 

4 reference 500, but we also say -- we talk about the 

5 concentrations of the waste and say based on the 

6 concentrations of long-lived waste that you're 

7 dealing with, here's the time frames you might want 

8 to consider in terms of site characteristics. 

9 MEMBER KIRCHNER: Thank you.

10 MR. ESH: Yes. So this is the figure 

11 of the performance assessment process, and what 

12 should be stressed is it is a learning process. 

13 The outer stuff on the pentagon is collecting data, 

14 developing the conceptual models, developing your 

15 numerical models, combining the models, and 

16 estimating the effects, while considering the site 

17 characteristics of the design and the waste form. 

18 That process is normally iterative in a performance 

19 assessment.

20 If the site is very complex, maybe you 

21 have a lot more iteration. If the site is simple, 

22 maybe it is once through, and -- and you are 

23 content with the results, but the performance 

24 assessment technical analysis is -- is iterative.

25 The requirements that were added in 
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1 this rulemaking are around the outside here, just 

2 to show how they fit into the overall performance 

3 assessment. So as I indicated, the three on the 

4 bottom there, or the one on the right and the two 

5 on the bottom with 61.13, that's scope uncertainty 

6 and the basis for your models. Those are kind of 

7 fundamental things to performance assessment. We 

8 did receive comments on it, but if you aren't doing 

9 those things in your performance assessment, you're 

10 -- you're probably not doing a good job with your 

11 performance assessment.

12 MEMBER SKILLMAN: David, you mentioned 

13 it's a continuous process. How often or how 

14 frequently is that circuit enacted?

15 MR. ESH: It depends on like in this, 

16 since these are in the Agreement States, it depends 

17 on the particular Agreement State. So I know in 

18 Texas they do an annual update to their performance 

19 assessment. Texas looks at that as one way to 

20 manage the facility and understand the performance 

21 and uncertainty and that sort of thing.

22 So they ask for an annual update. 

23 That's not a requirement in the regulations to do 

24 an annual update. To be on a -- I'm sorry Gary. 

25 Do we have a -- do you know, do we have a 
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1 requirement for an update frequency in the 

2 regulation? 

3 MEMBER SKILLMAN: That's why I asked 

4 the question. I'm looking for it and I don't see 

5 it here.

6 MR. COMFORT: Yeah, I'm not sure that 

7 we do.

8 MEMBER SKILLMAN: Why wouldn't you ask 

9 that?

10 MR. ESH: Well, we have a requirement 

11 to update it when you get to the point of closure, 

12 so ideally though, if you've done a good analysis 

13 when you establish your licensing basis, there may 

14 not be a need to do many updates as you operate the 

15 facility. It depends apparently also on the 

16 complexity of the site and the type of waste that 

17 you're receiving.

18 So the update period that may be 

19 appropriate for one might not be appropriate for 

20 another. We'll have to look and see here. Maybe 

21 we can. If Gary can look if I'm talking, if we 

22 added anything for that. But that was kind of the 

23 thinking behind should we put an update period in 

24 or not. The one thing we wanted to achieve is that 

25 when you get to that final decision point of saying 
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1 okay, I'm going to move to closure, you do an 

2 update then.

3 So that takes into account everything 

4 that may have happened during operations. A good 

5 operator is probably going to update before that, 

6 because they want to know ahead of time what they 

7 might be looking at, you know, but that's not a 

8 requirement. As long as you can demonstrate that 

9 you're safe at closure. Whether you have problems 

10 to address when you get to the closure point, the 

11 way it's structured now I believe that would be up 

12 to the licensee.

13 MEMBER SKILLMAN: But that almost flies 

14 in the face of the idea that you don't know what 

15 you don't know. If you're not taking a look 

16 periodically, you may very well be surprised?

17 MR. ESH: I think the reality is that 

18 all of them do take a look. So all of them 

19 periodically update their analyses to reflect their 

20 new inventory and the understanding on the site 

21 based on observations they might have, and I don't 

22 know. Maybe we'll hear once we get to the comment 

23 period. Any of the individuals in the room can 

24 elucidate what they do --

25 MEMBER SKILLMAN: What you're saying is 
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1 it's simply not required at this point in time.

2 MR. ESH: I don't believe so, but 

3 Gary's looking. So this next slide here on 

4 performance assessments, a visual representation of 

5 what a PA is and what it entails. You have to 

6 build all of this regardless of the compliance 

7 period. That's something I was stressing earlier.

8 So if you start on the upper left-hand 

9 side, you have a real site. You're going to 

10 develop a conceptual model for the site. Then from 

11 the conceptual model, then a performance 

12 assessment. There's lots of what I would describe 

13 as models within a model.

14 So you might have a model for the 

15 hydrologic performance of the site. You might have 

16 a model for the geochemistry of the site and a 

17 waste form performance. All of those things feed 

18 into the overall radiological dose assessment. So 

19 if you have 1,000 year compliance period or a 

20 10,000 year compliance period or some other number, 

21 you have to do all of these things to develop your 

22 models to evaluate your site.

23 As you go out in time, there may be 

24 unique features, events or processes, especially 

25 with lower frequency events that could come into 
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1 play. But that's part of the -- part of the Part 

2 61 approach to managing the uncertainties 

3 associated with low level waste disposal is the 

4 siting characteristics.

5 So you're supposed to consider the 

6 likelihood for seismicity and volcanism and erosion 

7 and subsidence and all those ologies that can 

8 stress your system and result in releases or 

9 impacts. Those are to be part of your performance 

10 assessment analyses, or a consideration of your 

11 site characteristics and then if necessary part of 

12 your performance assessment analyses.

13 So this idea that the burden is 

14 significantly different depending on the compliance 

15 period doesn't agree with our experience and it 

16 didn't agree with many of the other practitioners 

17 that we talked to. The main point that I would 

18 associate with the performance assessment is that 

19 the quality of the work, both in terms of the 

20 analyses but then in the actual operation of the 

21 site is what's going to determine whether public 

22 health and safety is protected, not necessarily the 

23 number that's spit out of the computer program.

24 So I mean that can't be lost on -- we 

25 spent a lot of this time talking about the 
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1 technical analyses and debating the requirements 

2 for it. But the other parts of Part 61 that are 

3 used by the regulator to evaluate the actual 

4 operation of the facility and to inspect against, 

5 those are the primary drivers of whether the 

6 facility is achieving its performance goals, not 

7 necessarily what may be going on inside a computer 

8 model.

9 Next slide, Please. So the inadvertent 

10 intruder assessment, it has always been part of the 

11 Part 61 framework. As I indicated previously, it 

12 was analyzed by the NRC, by us the regulator, and 

13 that analysis was not site-specific and it was not 

14 risk-informed, because we had to make certain 

15 assumptions about the site, such as that it's a 

16 human site. You had make certain assumptions about 

17 the waste that's going to go into it.

18 So the resultant waste classification 

19 tables are completely tied to the assumptions that 

20 the NRC put into the analyses, especially about the 

21 waste. So when we were faced with the issue of 

22 depleted uranium disposal, it basically represents 

23 an unanalyzed safety condition.

24 So if you've disposed of depleted 

25 uranium and you have not done an intruder 
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1 assessment, then you could potentially have a 

2 safety impact associated with that, because 

3 depleted uranium was not included in the waste 

4 classification tables. I don't know whether that 

5 was -- you could say that's NRC's fault, 

6 responsibility for not making that clear, or it's 

7 the implementer on the other side that didn't 

8 understand that issue.

9 But the fact of the matter is that the 

10 source terms that were analyzed were very well 

11 described in the environmental impact draft and 

12 final documentations. So if you, if I was a 

13 licensee and I was looking at disposing of new 

14 material, I could easily do a comparison to see 

15 whether okay, does this material fit in the box 

16 that, the regulatory box that was developed or not.

17 In the revised regulation, this is the 

18 main change, even though a lot of debate goes on 

19 about the time frames and a few other pieces, when 

20 this issue came up of whether we needed to change 

21 the regulation, I naively said that yes, we do. We 

22 only need to add the requirement to do an intruder 

23 assessment and it should only take three months. 

24 So I was a little bit off.

25 (Off mic comment.)
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1 MR. ESH: A little bit 

2 humbling. So in the revised regulation, the 

3 intruder assessment is now site-specific, which we 

4 think is much more powerful and much more flexible. 

5 It also creates some ancillary burden 

6 or effects especially on regulators. The 

7 site-specific intruder assessment allows the 

8 consideration of the actual waste, the site 

9 conditions and the expected receptor scenarios for 

10 that site.

11 So one of the comments ACRS gave us in 

12 this area previously was you don't need to do this 

13 intruder assessment. You can just consider the 

14 durability of the waste and the stability of the 

15 site. Yes, the durability of the waste and the 

16 stability of the site are important considerations, 

17 but how do you know what durability or stability 

18 you need if you don't consider the source of the 

19 material that you've put in the facility?

20 So the intruder assessment is one way 

21 to calculate how much of a particular type of salt 

22 waste stream or concentrations of radionuclides 

23 that your facility can take, at least from a 

24 protection of the inadvertent intruder.

25 We also felt that it was much more 
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1 difficult to design and justify the performance of 

2 a durable barrier, especially a durable barrier 

3 from the perspective of intruder protection, than 

4 it is to do the intruder dose assessment. The 

5 intruder dose assessments are usually much more 

6 simple than the performance assessments.

7 They represent on the order of, you 

8 know, ten percent of the effort of a performance 

9 assessment. So the intruder assessment yeah, while 

10 you could argue that what's the validity or policy 

11 reason for including the intruder. Part of that 

12 was derived from when Part 61 was developed, was 

13 around the time that like Love Canal, where you did 

14 -- people did dispose of waste and then it got 

15 disturbed and caused some health impacts. 

16 So that was kind of the mentality at 

17 the time. It ended up in part 61, and even though 

18 it is a regulatory analysis, we do think it has a 

19 good purpose because it is a check and balance in 

20 the system. So if you combine -- if you think of 

21 defense-in-depth, this is kind of defense-in-depth 

22 of regulatory analysis, combining the intruder 

23 analysis with the 6141 type of analysis gives you a 

24 type of defense-in-depth from the regulator's 

25 perspective.
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1 Next slide, Please. Now one of the 

2 important considerations, and this detailed charter 

3 or table here that on the left-hand side you have 

4 on your CD. So don't worry about trying to read 

5 this right now. 

6 It's the intruder, inadvertent intruder 

7 receptor is a very important topic, because the 

8 dose impacts associated with the inadvertent 

9 intruder can be driven by the types of activities 

10 that occur and especially how one may occur and how 

11 much disruption is associated with them.

12 What we've done in Part 61 is we 

13 followed the Commission direction of course, and 

14 the language associated with the intruder is shown 

15 in the draft final rule. But basically we say the 

16 intruder will potentially undertake normal 

17 activities such as dwelling, construction, 

18 agriculture, drilling for water, or other 

19 reasonable foreseeable activities consistent with 

20 the activities in the vicinity of the site when the 

21 assessment is development. 

22 So the direction that we received from 

23 the Commission prior to this was at site closure, 

24 to consider the activities in the vicinity of the 

25 site. Well, if a site operates for 50 or 60 years, 
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1 we felt that could be difficult for some and maybe 

2 draw them into, for instance, a legal argument as 

3 to how well they can project what the particular 

4 activities are 50 or 60 years in the future as 

5 compared to when now, in the present day.

6 If you have a requirement to update the 

7 analysis at closure, well that's when you should 

8 reflect if something different is going on at the 

9 facility, than rather trying to project it today 

10 what you think is going to be going on 50 or 60 

11 years from now. So that's -- you can look at that 

12 language as a slight deviation between the last 

13 version of the proposed regulation and the draft 

14 final regulation. 

15 Next slide, Please. This is a figure 

16 of some of those types of what we would consider 

17 normal activities, normal from the standpoint of 

18 people are always going to look for some place to 

19 live and they need to eat and they need to drink 

20 water. Those are things that people do today. 

21 Now where they get their water from can 

22 vary substantially. What they live in can vary 

23 substantially and where they get their food from 

24 can vary substantially. So but we also would say 

25 that while you can and should consider the 
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1 site-specific characteristics, you should also 

2 perceive with caution in defining your receptors, 

3 because on one hand you want to argue that there's 

4 enormous uncertainties that make the results 

5 unusable.

6 But on the other hand, then you turn 

7 around and say but I can accurately define what my 

8 receptors are and what they're doing. Those two 

9 things are kind of diametrically opposed. You 

10 choose one or the other. 

11 So and if you think you have 

12 imagination with developing intruder receptor 

13 scenarios, wait until you interact with your 

14 stakeholders and see the intruder receptor 

15 scenarios that they may propose to you.

16 So that is a slippery slope. The 

17 flexibility is afforded there. The intruder is a 

18 regulatory construct. It's not a risk calculation, 

19 and it is used effectively on low level waste 

20 disposal, both on the commercial side and DOE, both 

21 entities do this intruder assessment. 

22 And of course I guess looking at these 

23 figures, these are obviously not just scale unless 

24 we have like 12 feet tall people in the future. 

25 So next slide, Please. Site-specific 
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1 scenarios, I just talked about that a little bit. 

2 We think you should consider them, and they can be 

3 used to constrain the exposure pathways for the 

4 normal activities or for reasonable foreseeable 

5 activities, and it's much better to base that on 

6 physical information, things that might be durable 

7 over time such as that the water is not potable and 

8 it's going to remain not potable, rather than 

9 cultural information such as well, there's no 

10 housing development there today. Therefore, there 

11 will never be a housing development there.

12 If the environment is such that it's 

13 very unlikely to support a housing development, 

14 well that's one thing. But you know I still get 

15 pulled back to that Las Vegas example. I think 

16 that challenges me from relying too heavily on 

17 cultural information.

18 Next slide, Please. Site stability is 

19 the third component of the technical analysis. 

20 It's an important part of the safety strategy. The 

21 original regulation said stability is a cornerstone 

22 of disposal. We are not backing away from that. 

23 We still believe stability is the cornerstone of 

24 disposal.

25 Part of that arose from the early 
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1 problems that occurred in low level waste 

2 facilities. There were a lot of stability issues 

3 with the facilities that were developed prior to 

4 Part 61. And even more recently with one of the 

5 existing facilities had an event or incident 

6 associated with what I would call stability issues, 

7 the Beatty facility in Nevada.

8 We did revise in response to public 

9 comment the stability definition, because the 

10 stability definition was somewhat circular than the 

11 existing regulation. Stability is structural 

12 stability. So we tried to provide a better 

13 definition for stability in this final version of 

14 the regulation.

15 Next slide, Please. Site stability. 

16 The guidance in Chapter 5 provides a lot of detail 

17 on this. It's also somewhat of an iterative 

18 process starting with site characterization, what 

19 are your hazards, what are your disruptive 

20 processes both natural and anthropogenic, doing 

21 some sort of either technical analysis or technical 

22 assessment combined with engineering design.

23 It's pretty much two different 

24 approaches or a combination of the two that can be 

25 used to demonstrate stability. For instance, 
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1 there's an appendix to the guidance document that 

2 has examples both for the stability analyses that 

3 was done for decommissioning at the West Valley 

4 site, which is one of the most challenging sites 

5 with respect to stability.

6 And then there's an appendix that has a 

7 technical evaluation report from uranium mill 

8 tailings management, where in that area usually 

9 design-based approaches are used to develop erosion 

10 protection. So those are based on determining that 

11 PMF, probable maximum flood from the probable 

12 maximum precipitation, and then from that designing 

13 your erosion protection systems, the sizing of your 

14 ripwrap (phonetic) and your drainage channels and 

15 all those sorts of things.

16 Now there's a TER with some information 

17 around it in there that we gave examples about the 

18 technical approach and the modeling approach. Then 

19 you combine that with the evaluation and 

20 monitoring.

21 Next slide, Please. So the site 

22 stability should consider the temporal and spatial 

23 scales. The temporal and spatial scales associated 

24 with the site stability analysis should be a 

25 function of the waste. So we -- if you have 
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1 primarily short-lived waste, and you're primarily 

2 looking at the waste at the site itself and the 

3 disposal trenches and whether you can ensure the 

4 stability of those.

5 When you start moving out to 

6 longer-lived waste in higher concentrations, when 

7 that is tied, of course it triggers when you might 

8 need to do a longer-term analyses, and a 

9 longer-term analyses means the scope of your 

10 stability assessment and how you're bringing in the 

11 geomorphological considerations becomes a larger 

12 area that would be important to consider. But some 

13 of that can be seen in the examples that we 

14 provided in the guidance document.

15 So that's pretty much the end of the 

16 technical analysis part, and now we'll transition 

17 into waste acceptance criteria. The technical 

18 analysis may feed the waste acceptance criteria 

19 depending on the approach that's selected by the 

20 licensee. 

21 The licensees must review their waste 

22 acceptance program at least annually, and this is 

23 the primary mechanism that you ensure that the 

24 waste that is sent and received and disposed is 

25 going to meet the technical criteria based on the 
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1 analysis that you performed to license the 

2 facility.

3 So the three components to the waste 

4 acceptance requirements are characterization, the 

5 criteria themselves and then the certification, and 

6 the first thing that I'll talk about is the 

7 criteria. 

8 Next slide, Gary. So the waste 

9 acceptance criteria are made up of the allowable 

10 limits on radioactivity, the waste form 

11 characteristics and container specifications and 

12 then any restrictions and prohibitions. The last 

13 two bullets here are really lumped together in 6156 

14 in the regulation under waste characteristics. So 

15 that lists the types of restrictions and 

16 prohibitions and the characteristics that the waste 

17 may or may not have.

18 The allowable limits on radioactivity 

19 may be on a package basis, or they may also be on 

20 the overall facility. The waste form 

21 characteristics and container specifications 

22 include things like it can't be disposed of in a 

23 cardboard box. You have solidify liquids. You 

24 can't dispose of explosives. You can't have waste 

25 that's pyrophoric or it contains chelating agents. 
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1 They're all things that are important things from a 

2 performance standpoint.

3 As an engineer when I look at the waste 

4 characteristics and the prohibitions and 

5 restrictions, I think that's a much -- one of the 

6 most effective risk management components of the 

7 regulation, regardless of all the technical 

8 analyses and everything else. If you put 

9 pyrophoric material in a facility, you're asking 

10 for trouble, right.

11 So the requirement that prevents 

12 pyrophoric material from going in is a very 

13 important requirement to ensure the longer term 

14 performance or performance of the facility after 

15 closure. 

16 Next slide, Please. So in this draft 

17 final rule, as within the previous version, there's 

18 flexibility to develop site-specific waste 

19 acceptance criteria. So you can use the 6155 

20 limits. You can use the results of technical 

21 analyses or a combination of both to develop your 

22 criteria.

23 So either way though, the licensee must 

24 demonstrate that the criteria will demonstrate the 

25 performance objectives will be met. So the 
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1 important point in this is that the licensees have 

2 considerable flexibility, and generally you would 

3 be considering the concentration and the inventory.

4 So even in the existing Part 61, 

5 there's language that references the consideration 

6 of the inventory of the material you're disposing 

7 of, in addition to the waste classification tables. 

8 So long-lived mobile isotopes, there was an 

9 identification in the early 1980's that you might 

10 need to develop inventory limits for those 

11 isotopes, technetium, iodine, technetium-99, 

12 iodine-129, tritium and carbon-14.

13 The reason why a licensee and you might 

14 be thinking to yourself well why does the licensee 

15 need to do this third bullet if they're doing the 

16 other things, or especially if they're using the 

17 6155 concentration one. It's because of the 

18 problem I talked about earlier. 

19 The 6155 concentration limits were 

20 developed for a specific waste. So if your waste 

21 is outside the envelope of what was considered when 

22 they were developed, you basically have an 

23 unanalyzed safety condition there potentially.

24 So that's why this requirement to meet 

25 the performance objectives must be demonstrated, 
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1 even if you're using the 6155 limits. 

2 As I indicated earlier, three of the 

3 four existing sites on the commercial side have 

4 already analyzed intruders, and in the DOE practice 

5 it's part of their requirements to analyze 

6 intruders. 

7 So the next slide, Please. The 

8 allowable limits from 6155. This is what the 

9 process looks like. It looks complicated but it 

10 really isn't. The part I just talked about on the 

11 previous slide is really top two boxes on the 

12 diagram. After that, it's everything else you're 

13 doing to meet the requirements associated with the 

14 waste.

15 So the determination of the limits is 

16 rather straightforward, whether it's based on the 

17 concentrations and the sum of fractions or you need 

18 to develop some sort of inventory limits. The 

19 other requirements take up most of the diagram. 

20 Next slide, Please. So if you were 

21 developing allowable limits from analyses, this is 

22 how it might look like, something like this. Of 

23 course this is the flexibility that provides you 

24 the ability to look at the site-specific 

25 characteristics. It's very powerful. 
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1 But then that power also then triggers 

2 the need for a thorough review by a competent 

3 regulator, because if you're basing what the 

4 facility can take on the analyses, you have to 

5 ensure that the proper quality and valuation was 

6 done of that analyses, that the results are 

7 correct.

8 This was a concern for a number of 

9 stakeholders. They described it as putting the fox 

10 in charge of the hen house I think, which was kind 

11 of a good layman's way of describing it. I said 

12 no, you're not putting the fox in charge of the hen 

13 house but if you are, the regulator is the farmer. 

14 So I mean you still have somebody that's supposed 

15 to mitigate or evaluate and make sure that the 

16 decision is going to be safe.

17 MEMBER BLEY: Dave, I have a question. 

18 If we have reg guide and we have the SRP, I know 

19 how that works. If we have a NUREG as the 

20 guidance, does that serve both functions? Is that 

21 the guidance for reviewers as well, or are you 

22 going to have an SRP on this?

23 MR. ESH: Right. We have an SRP for 10 

24 C.F.R. Part 61 that was developed based on the 

25 existing regulation.
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1 MEMBER BLEY: Right.

2 MR. ESH: And it is quite voluminous, 

3 and we looked at that and we said ideally, we would 

4 like to develop an SRP that would go along with the 

5 new regulation. 

6 But at the time, I think there was a 

7 decision that supplementing existing guidance by 

8 putting in discussion in areas that were new was 

9 the appropriate way to go for this rulemaking 

10 because it was supposed to be a limited scope 

11 rulemaking, right.

12 So you know, I mean you laughed at 

13 that. It was supposed to be a limited scope 

14 rulemaking. So that made sense to supplement the 

15 guidance rather than wholesale revising it. Now 

16 my personal opinion is just like we did in 

17 decommissioning, with doing a whole-scale revision 

18 of the guidance there and consolidated the guidance 

19 of what I think Derek participated in before his 

20 life here.

21 (Off mic comment.)

22 MR. ESH: Yes. That would be a useful 

23 activity to undertake in the low level waste area, 

24 but it would be very resource intensive and 

25 considering the climate with Project Aim and agency 
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1 resources, I just don't know whether they would 

2 devote the resources to --

3 MEMBER BLEY: Well, let me push that a 

4 little. I know somebody else wants to talk, but 

5 just a minute. The old SRP can't, I can't expect 

6 that it would be appropriate here. But I could 

7 expect, depending on what we see in this document, 

8 that it might be complete enough and clear enough 

9 that it would serve the purpose as guidance for a 

10 reviewer as well.

11 And on the other hand, if we don't have 

12 good guidance because we don't want to spend the 

13 money to get it, we might pay a hell of a price and 

14 so might the licensees when the reviews come 

15 around.

16 MR. ESH: Right, and I don't want to 

17 give that impression because the existing SRP, I 

18 think, provides a lot of guidance for the areas of 

19 the regulation that were not touched in this 

20 rulemaking. There are a lot of areas that aren't 

21 touched in this rulemaking. I mean a lot of the 

22 language changes in say 61.7. 61.7 does not 

23 provide requirements. 

24 It's just basically the concepts of 

25 setting the stage for how everything fits together. 
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1 So you know, we received a lot of comments about 

2 our changes to that section, but the reality is 

3 that really doesn't mean anything in terms of 

4 compliance with requirements in the regulation.

5 In the areas that we did change, that's 

6 where we hope this guidance document comes into 

7 play, to provide information in the areas that we 

8 did change. So Chris, I don't know if you had a 

9 comment.

10 MR. McKENNEY: Chris McKenney from the 

11 -- Branch. The one that's also in front of the 

12 Commission right now is a programmatic assessment

13 for the low level waste program, and one of the 

14 actions -- one of the possible actions within the 

15 next five years is a consolidation of all of our 

16 guidance, to try to revise our older guidance and 

17 bring it -- and bring the guidance that is 

18 necessary into a consolidated set of guidances.

19 There's a couple of options there of 

20 guidance for operators and possibly guidance for 

21 generators, and of course resource requirements for 

22 that. And as Dave mentioned, for this guidance 

23 compared to NUREG-1200, this would only be like 

24 part of Chapter 6 of NUREG-1200, because even 

25 Chapter 6, which is the technical types of 
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1 analyses, had also accidents and everything else 

2 and stuff which during operations, which this 

3 doesn't even cover those sort of things.

4 This guidance still does cover a number 

5 of things that the reviewers could use in that 

6 analyses for -- NUREG-2175 does cover a number of 

7 things, and with our reliance on our previous 

8 analyses in NUREG-1573, which is the previous low 

9 level waste guidance on performance assessment, 

10 which we put out in 2000, which was also written 

11 for both reviewers and the license community.

12 Again, was a combined sort of mixture 

13 of SRP and guidance to the community, not an SRP 

14 but not a -- just a pure guidance document.

15 MEMBER BLEY: Right, okay. It kind of 

16 all sounds reasonable to me. One question. After 

17 the rule becomes a rule, how soon do you anticipate 

18 staff would begin receiving analyses that they need 

19 to review in this area?

20 MR. ESH: Well, the short answer to 

21 that is not any time soon because they would all be 

22 received in Agreement States. So all the 

23 facilities are in Agreement States. The Agreement 

24 States would have a period of time after our rule 

25 becomes final to make the corresponding changes in 
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1 their regulations and make them final, and then 

2 they would have, receive the updated analyses in 

3 their Agreement States, which they -- the language 

4 is, I think --

5 MR. COMFORT: Five years or the next 

6 renewal.

7 MR. ESH: Five years or the next 

8 renewal.

9 MR. COMFORT: Whichever's earlier.

10 MR. ESH: So it would depend on when 

11 their rule got final and then when the next renewal 

12 was.

13 MEMBER BLEY: And the states that are 

14 not, our staff would review?

15 MR. ESH: They would, and just like 

16 always, we're available to help them or provide 

17 input to them. We have two different versions. We 

18 have one that's kind of a less detailed input to 

19 their process, and then one that's a more formal or 

20 more detailed input to their process, where I 

21 believe they reimburse the agency for our time if 

22 it's the latter one. If it's the former one, then 

23 we supply that voluntarily.

24 MEMBER BLEY: Okay, and then these 

25 areas, this reg guide would provide them guidance 
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1 as well as the licensees?

2 MR. ESH: Right. 

3 MEMBER BLEY: Okay.

4 MR. ESH: So allowable limits.

5 MEMBER SKILLMAN: David, let me ask 

6 this please. Here are five assessments, and you 

7 mentioned a key word which is quality, and I look 

8 at the red line strikeout and I see quality 

9 identified as a concept. I'm just wondering what 

10 the vision is for the quality that is acceptable 

11 for these analyses. What is it that you use to 

12 ensure that you're getting a durable and 

13 responsible product?

14 MR. ESH: Right. So in the regulation, 

15 I believe we had a requirement for, associated with 

16 quality assurance of the analyses, because we felt 

17 that was important, and then in the guidance 

18 document, we've added -- and that's in the area 

19 where, one of the areas where I would say you 

20 should take a look at.

21 We added material associated with the 

22 quality assurance of developing models, data, all 

23 the components of the technical analyses. We put 

24 material in there referencing various quality 

25 assurance procedures and documents. 
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1 MEMBER SKILLMAN: Thank you.

2 MR. ESH: Next slide, please, and I'll 

3 try to hustle through these so we aren't too far 

4 behind. Waste characterization is the -- waste 

5 characterization and waste certification are the 

6 other two pieces to the waste acceptance 

7 requirements. The licensees must specify 

8 acceptable methods for characterizing the waste.

9 Now detection methods have improved

10 significantly, but there's still a source of 

11 uncertainty associated with what exactly the 

12 inventory is, especially for the long-lived mobile 

13 isotopes, because they're generally hard to detect, 

14 especially if in the presence of some other 

15 isotopes that are -- confound their identification.

16 We have new guidance associated with 

17 that, that allows the use of scaling factors and 

18 also indicates that say for performance assessment, 

19 in some cases a practice was that if a measurement 

20 was done and the isotope was at the lower limit of 

21 detection, then a value of zero was assigned in the 

22 inventory for the performance assessment.

23 Well, if the lower limit of detection, 

24 if it's below the lower limit of detection, you 

25 know it's below that, but it doesn't necessarily 
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1 mean it's below zero. The challenge is that when 

2 you assign a lower limit of detection, even if the 

3 lower limit of detection it was causing some 

4 performance issues in some analyses.

5 So that's where the consideration of 

6 scaling factors and some other approaches that 

7 developed the inventory may come into play and may 

8 be useful. So we hope that that's a reasonable 

9 approach to deal with this issue of inventory 

10 uncertainty. 

11 The waste characterization is to ensure 

12 that knowledge of the waste characteristics is 

13 commensurate with the assumptions and approaches 

14 used to develop the waste acceptance criteria, and 

15 sufficient to demonstrate that the waste acceptance 

16 criteria are met.

17 Next slide, Gary. The characterization 

18 methods may be -- I talked about this some --

19 direct or indirect, such as materials 

20 accountability, characterization by source or 

21 scaling factors. Data quality comes into play 

22 here, quality of the technical analysis we just 

23 talked about, and also the documentation of the 

24 responsibilities for characterization, quality 

25 assurance of procedures and records. 
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1 The guidance that has been developed 

2 addressing data quality and documentation. So if 

3 you want to rely on technical analyses to develop 

4 your waste acceptance criteria, then you need to 

5 ensure that those analyses are transparent and 

6 traceable, and they should be publicly available 

7 to your stakeholders.

8 You know, you should be able to weather 

9 the storm of the criticism that you might get and 

10 be able to answer the questions that the 

11 stakeholders might have about your analyses. 

12 What's shown here on the right of the 

13 characterization methods slide, there's one way to 

14 go about characterizing data using like a data 

15 quality objectives process.

16 First, you develop your data quality 

17 objectives, then you obtain the data, then you 

18 evaluate the data and you iterate if necessary. So 

19 it's plan, implement, assess, decide. 

20 Next slide, please. Waste 

21 certification is the third piece to the waste 

22 acceptance requirements, and that's the program to 

23 certify that the waste meets the acceptance 

24 criteria prior to receipt at the disposal facility. 

25 So this has been modeled after DOE's program. They 
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1 do this in their facilities because for quite some 

2 time now they've used site-specific analyses to 

3 develop their waste acceptance criteria at their 

4 sites.

5 The waste certification process can be 

6 important for the generators and the operators, and 

7 if people aren't used to using that, I'm sure there 

8 will be some growing pains to get that implemented.

9 Next slide, please. So now a few 

10 slides about the guidance. The guidance changes 

11 that we've made are generally in support -- well, 

12 the guidance is in support of the regulations, and 

13 we've developed guidance for the licensees and 

14 Agreement State regulators to provide approaches 

15 that the NRC finds acceptable to meet the 

16 regulatory requirements.

17 Of course Agreement States and 

18 licensees may come up with their own methods to 

19 satisfy the regulatory requirements, as long as 

20 they can demonstrate that the requirements are met. 

21 The guidance that we developed we hope is useful to 

22 licensees and the Agreement State regulators.

23 If we were evaluating an application, 

24 that's the document, combined with many others, 

25 that we would use. It is around 500 pages or so. 
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1 It's not all words though, so you'll have to be the 

2 judge whether it's a good sleep aid to you or not 

3 if you need that sort of thing.

4 There are many examples provided, and 

5 some figures and that sort of thing. So hopefully 

6 it's not just reading all dry regulatory text. We 

7 do have in there suggested references, screening 

8 tools and case studies, a variety of other 

9 information. One important thing to note about the 

10 guidance is, and I can't make this enough -- can't 

11 make this point enough times is that guidance does 

12 not provide requirements.

13 So requirements are provided in the 

14 regulation. Guidance provides methods that you may 

15 use to satisfy the regulatory requirements. So 

16 we've received lots of comments, especially from 

17 some stakeholders that kept saying things about the 

18 requirements in the guidance, and it's just a 

19 misinterpretation of what guidance is in the 

20 regulatory approach.

21 We did not receive as many comments on 

22 the guidance nearly so as we did on the regulation, 

23 possibly due to length of the document. We really 

24 tried to get comments on it. We did receive some 

25 good comments from a variety of stakeholders, but 
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1 it was a bit of a challenge to get comments on it.

2 It will be issued at the same time as 

3 the proposed rule, so sorry, as the final rule. It 

4 will be issued the same time as the final rule. 

5 Oh, I'm sorry. I'm misreading my bullet here. The 

6 draft NUREG was issued at the same time as the 

7 proposed rule. The final NUREG will be issued at 

8 the same time as the final rule.

9 It was discussed in seven public 

10 meetings, including a webinar that was dedicated to 

11 it and we have the same public comment for it as we 

12 did for the rest of the regulation. The guidance 

13 such as the NUREG is easily revised or easily as 

14 defined in relation to developing a regulation. 

15 So it still might be a bit 

16 time-consuming, but it's way easier to revise 

17 guidance than it is to change a regulation. So we 

18 expect that in the future, there may be the need to 

19 revise or supplement the guidance document, even if 

20 we don't have that need to do anything with the 

21 regulation. But that of course would depend on 

22 resources. Next slide, please.

23 MEMBER REMPE: Just a question, though. 

24 Like if we had a discussion of this topic at our 

25 full Committee meeting, right now the disks you 
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1 gave us are not openly available with the guidance 

2 document. Do you anticipate that you'll be done 

3 with your effort so it will be public by the first 

4 week of November?

5 MR. ESH: I don't believe so, because 

6 it has to be held to -- before it can be made 

7 final, we have to see what the final changes to the 

8 regulation may be. So we have to wait and align it 

9 with that, and that's primarily why it's held back.

10 Now the version that you got right now, 

11 if we didn't get any changes to the regulation, 

12 that would be the final guidance document. We 

13 don't anticipate any changes -- right now, we don't 

14 have any additional changes to that document. So 

15 yeah.

16 The comments that we received on the 

17 guidance document were mainly in alignment with the 

18 rule comments, such as in the analysis time frames. 

19 There was a lot of discussion about the protective 

20 assurance period, which Gary discussed in the three 

21 tiers that he said it's confusing and it should be 

22 eliminated.

23 There was comments about 

24 defense-in-depth and the requirement for analyses. 

25 So that we already covered in detail. There was 
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1 confusion on the various time frames, like I showed 

2 you that figure, a version of it that we put in the 

3 guidance document. We had questions about the site 

4 closure process, so there's more new material on 

5 that, including the development of say permanent 

6 markers to identify the site at closure, and there 

7 was some clarification on the inadvertent intruder 

8 assessment scenarios in the guidance.

9 MEMBER BLEY: One question about the 

10 comments. In the big package that was released, 

11 there's the summary of comments and your responses. 

12 Did you get many comments beyond those from 

13 licensees and the state regulators?

14 MR. ESH: You mean on the guidance 

15 document?

16 MEMBER BLEY: Well on both.

17 MEMBER SKILLMAN: On both.

18 MR. ESH: The comments on the rule were 

19 from a whole variety of different stakeholders, 

20 members of the public, licensees, Agreement State 

21 regulators, other trade and industry organizations, 

22 environmental groups. It was a wide smattering of 

23 groups that provided comment on it. On the 

24 guidance document, it was much more limited to some 

25 of the licensees and Agreement State regulators.
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1 MEMBER BLEY: Okay, thanks. I hadn't 

2 seen a list of all those.

3 MR. ESH: Right. So all the comments 

4 are publicly available that we received on the 

5 rule. The responses for the guidance documents, 

6 the comments on the guidance document are an 

7 appendix to the guidance document. So you have 

8 that on your CD.

9 So the major revisions made were of 

10 course in the analysis time frame area. We 

11 eliminated the protective assurance period and we 

12 modified the compliance period discussion. We 

13 added detailed examples of how to determine if a 

14 site has significant quantities, because that 

15 drives your compliance period selection for either 

16 the 1,000 year value or the 10,000 year value.

17 We clarified the information on 

18 defense-in-depth. A variety of figures describing 

19 the state closure process, the time frames and the 

20 process for developing allowable limits, and as I 

21 indicated, we have the appendix for the public 

22 comments. We also had an appendix on the 10 C.F.R. 

23 Part 61 draft environmental impact statement DEIS 

24 default scenarios.

25 So that provides some background to 
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1 what was analyzed for the intruders, in case people 

2 wanted to analyze similar intruders in their 

3 site-specific analysis. So they have the details 

4 for how they would do that. So I guess either I 

5 would entertain questions now or turn back to Gary. 

6 He's going to do a path forward summary I think, 

7 right.

8 CHAIRMAN CHU: Because we're running 

9 late in the schedule, I recommend if there are any 

10 more questions we hold them until the end of the 

11 agenda, because we have still a couple of things. 

12 People are lining up, but I want to first thank you 

13 for, the two of you for your excellent and 

14 comprehensive presentations, you know. If you 

15 could stick around a little bit, there may be more 

16 questions. Now we're going to turn to the -- go 

17 ahead.

18 MEMBER BLEY: Well, another path 

19 forward presentation.

20 CHAIRMAN CHU: Oh you have another one?

21 MR. COMFORT: Well, it's just a real 

22 quick summary of where we're going from here. All 

23 it is basically is the Commission currently has, 

24 you know --

25 CHAIRMAN CHU: Oh please, go ahead, go 
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1 ahead. Yeah, okay.

2 MR. COMFORT: Yeah, and they're 

3 reviewing it. They'll you know presumably be 

4 receiving your letter and take that into account. 

5 My understanding is they're also talking to some 

6 other stakeholders and stuff who have been 

7 interested in the rule. They'll eventually come 

8 out with a decision on the rule, whether to go 

9 forward with it or not. 

10 Should, you know, our expectation and 

11 hope is that they'll go forward with it. They may 

12 have changes related to that. Once they do give us 

13 direction that they do want us to move forward and 

14 publish the rule, we'd make any minor changes that 

15 they wanted us to do.

16 The package is then sent to the Office 

17 of Management and Budget for review under the 

18 Paperwork Reduction Act. Once we get their 

19 approval, then we publish it in the Federal 

20 Register. Under the terms of this rule, it would 

21 be effective one year after the publication of the 

22 rule itself.

23 Now since we don't have any licensees, 

24 that really doesn't mean a lot, unless a new 

25 licensee happened to come in. The Agreement 
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1 States who do have the licensees will have three 

2 years from the date of publication to incorporate 

3 compatible regulations. Presumably, they would use 

4 the same implementation time period that we put in 

5 our rule, which is for existing licensees. 

6 They'd have up to five years or the 

7 next renewal to provide an update to their 

8 application on it. So likely some of these 

9 Agreement States may not see an application for 

10 seven or eight years under this time scale. That's 

11 really where -- and I was going to answer real 

12 quick the question about updating the performance 

13 assessments.

14 It's not specifically stated in the 

15 rule, but based on the language in the rule, they 

16 would have to update it minimally at the time of 

17 renewal, because they'll have to apply up to date 

18 information in their application, and their 

19 application has to include a technical analyses and 

20 all.

21 It would also be expected that in 

22 certain circumstances, such as if they were 

23 changing their waste acceptance criteria, they may 

24 have to go back and look at it and evaluate and 

25 update it to support the waste acceptance 
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1 criteria. 

2 MEMBER SKILLMAN: Yeah. My concern was 

3 addressed by the timeliness of the one year review 

4 of the waste acceptance criteria. That took care 

5 of my real concern. Thank you.

6 MR. COMFORT: That's it.

7 CHAIRMAN CHU: Thank you. We're going 

8 to go to the next agenda item with comments from 

9 Dr. James Clarke. I hope he's still there. 

10 MEMBER BLEY: Jim are you on the line? 

11 Try to talk to us, see if your line's open.

12 MR. CLARKE: I think I'm on right now.

13 MEMBER BLEY: Yep, you're okay. We 

14 hear you.

15 MR. CLARKE: Okay. Well thank you. 

16 It's a real pleasure to participate in this 

17 meeting. Let me do a sound check. I have a 

18 tendency to fade. Can you all hear me?

19 MEMBER BLEY: Very good right now.

20 MR. CLARKE: Okay and also I --

21 MEMBER BLEY: And your slides are on 

22 the board.

23 MR. CLARKE: Okay, good. I want to 

24 extend my congratulations to David Esh on his very 

25 well-deserved honor. David, congratulations. 
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1 MR. ESH: Thank you.

2 MR. CLARKE: Oh, you're welcome. So 

3 let me start with the first slide. I have slides 

4 that provide an introduction to CRESP. It's an 

5 mouthful of an acronym. I'll spell it out in a 

6 minute. I also have slides summarizing the 

7 comments that CRESP submitted. This organization 

8 submitted comments in 2013 and 2015.

9 Since CRESP didn't provide any further 

10 comments, I have a few of my own in my capacity as 

11 a member of the former -- and that should be NRC, 

12 ACMW now, and as a consultant to the ACRS. All of 

13 this material is at a very high level necessitated 

14 by the time I have, and answer any questions you 

15 might have. So I'd be pleased if it would be 

16 helpful to provide the ACRS with a more detailed 

17 report. If you'd like that, that would be great. 

18 And then I'm Jim Clarke of Vanderbilt University. 

19 So the next slide, please. Just an 

20 introduction to CRESP. It's the Consortium for

21 Risk Evaluation with Stakeholder Participation, and 

22 it's a university, multi-university consortium led 

23 by Vanderbilt, and I believe it goes back to Tom 

24 Grumbley (phonetic). So I think that would be 

25 somewhere in the late 90's.
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1 The management board is shown there. I 

2 think some of you know David Kosson. He is our 

3 principal investigator. You may know Steve Krahn 

4 and Shlomo Neuman. Craig Benson I know is on the 

5 line with you folks, so you may recognize some of 

6 those names and the universities that are 

7 represented are shown there as well. Next slide, 

8 please. 

9 MR. COMFORT: Go ahead.

10 MR. CLARKE: Right now, I am trying to 

11 change my own slides.

12 (Laughter.)

13 MR. COMFORT: I can't help you with 

14 that.

15 MR. CLARKE: Here we go. A little bit 

16 about the CRESP mission. I worked with an attorney 

17 a long time ago on a lot of merger acquisitions for 

18 corporations, and you know, she would call this 

19 happy stuff. But basically what we're all about is 

20 safe, effective publicly credible risk-informed 

21 management of existing and future nuclear waste, 

22 and you can see the rest for yourself.

23 We are independent. We do give advice 

24 to the Department of Energy. They don't always 

25 like it, but that's our situation. 
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1 Next slide, please. We operate under a 

2 cooperative agreement, and basically as you know, 

3 we provided comments on the 2013 and 2015 drafts. 

4 Next slide. So I would say that we 

5 applaud and strongly support the Nuclear Regulatory 

6 Commission's risk-informed performance-based 

7 approach, and I'm a true believer of that. I 

8 remember the first time I came to an NRC meeting 

9 and somebody said risk-informed, I said "what's 

10 that." I know what risk-based is, but what's 

11 risk-informed, and you know it's truly, truly a 

12 good approach, a wonderful approach and we strongly 

13 support it.

14 If we took issue with anything in the 

15 proposed regulations, it was because we believe 

16 that the NRC was departing from a risk-informed 

17 performance-based approach. 

18 Next slide, please. This is just a 

19 very brief summary of some of our comments, but 

20 several provisions in the draft rules, both in 2013 

21 and 2015, and this quote comes I believe from our 

22 first comment in 2013. "Commendably reflect and 

23 implement a risk-informed performance-based 

24 approach. Notably provisions for site-specific 

25 waste acceptance criteria, site-specific 
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1 performance assessment and updated dosimetry in the 

2 2013 comments."

3 And then the site-specific 

4 assessment to exposure to an inadvertent intruder, 

5 provisions for defense-in-depth and safety case 

6 evaluations we thought were very positive 

7 additions.

8 Next slide, please. However, we did 

9 express concerns that there were parts of the 

10 regulations or proposed regulations, but we didn't 

11 think that the NRC was taking the risk-informed 

12 performance-based approach, and in particular the 

13 continued incorporation of very long time frames 

14 that greatly exceed our experience and forecasting 

15 abilities.

16 So this is really, really the heart of 

17 my comments, these long time frames. We talked 

18 about 1,000 years, 10,000 years and beyond 10,000 

19 years, and that's at the heart of the comments that 

20 we made, and at the ones that I will now make from 

21 a personal standpoint. 

22 So the next slide, please. These are 

23 my comments. It appears the staff concerns that 

24 are reflected in the rule stem from the appearance 

25 of long-lived radionuclides, large quantities, from 
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1 activities that were unanticipated, and these are 

2 understandable and legitimate concerns. 

3 However, they should be addressed 

4 through regulations in a way that's consistent with 

5 NRC's risk-informed performance-based approach, and 

6 it strikes me that I have used risk-informed 

7 performance-based probably more in these few 

8 minutes than I've heard.

9 Next slide, please. The draft 

10 regulations were revised to eliminate protective 

11 assurance period. This has been covered, from 

12 1,000 to 10,000 years. However, the revision now 

13 states that the compliance period would be either 

14 1,000 or 10,000 years, depending on the inventory 

15 and the concentration of long-lived radionuclides.

16 However, a compliance period of 10,000 

17 years, I think, is neither risk-informed nor 

18 performance-based. This time period is outside our 

19 current body of knowledge, and it greatly exceeds 

20 our ability to forecast the future. My personal 

21 feeling is that our current ability would be better 

22 limited to a few hundred years. But I appreciate 

23 the 1,000 years has some standing, for example with 

24 the Department of Energy.

25 Next slide. With respect to the 
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1 intruder assessment, I appreciate that the staff 

2 was directed to use 10,000 years. I have the same 

3 concerns about the merits, and I think my 

4 understanding is that the Commission said to use 

5 the 10,000 years in the guidance, but I believe 

6 it's on the draft regulations.

7 So whether, you know, this is in other 

8 cases, should be approached on site-specific, kind 

9 of site-specific basis. So in summary, I've just 

10 got a few more here. In summary I appreciate that 

11 the appearances in large amounts of long-lived 

12 radionuclides requiring disposal in waste streams 

13 that didn't exist were unanticipated when 10 C.F.R. 

14 61 was first promulgated.

15 These unanticipated events appear to be 

16 driving the regulations to positions that are 

17 neither risk-informed in my opinion nor 

18 performance-based. For example, 10,000 year 

19 compliance periods and 10,000 year intruder 

20 assessments. 

21 Next slide. Perhaps these 

22 unanticipated waste streams, which has depleted 

23 uranium can be handled in other ways, and that's 

24 really what I'd like to suggest, possibly through 

25 guidance, but in ways that don't require 
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1 unrealistic compliance periods. I can't help but 

2 wonder what if we took long-lived radionuclides out 

3 of the main body of 10 C.F.R., perhaps they could 

4 be treated as exceptions, maybe as special waste. 

5 But they appear to be driving the regulations.

6 Next slide, please. So I just have a 

7 few closing comments. I know we're running short 

8 on time, but my experience with the NRC covers over 

9 16 years, consultants to the Advisory Committee on 

10 Nuclear Waste, member of the Advisory Committee on 

11 Nuclear Waste and Materials and now a consultant to 

12 the Advisory Committee on Reactor Safeguards.

13 I appreciate the opportunity to tell 

14 you all that the people from the NRC with whom I've 

15 had the pleasure to work are truly extraordinary. 

16 We just heard from two of them, and indeed I hold 

17 the NRC and its staff in very high regard. We just 

18 apparently disagree over the merits of including 

19 extremely long time periods as compliance periods 

20 in enforceable regulations.

21 That was my last line, and I appreciate 

22 the opportunity to provide these comments, both on 

23 behalf of CRESP and me, and I'd be pleased to 

24 address any questions you might have.

25 CHAIRMAN CHU: Thank you Dr. Clarke. 
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1 Any questions for Dr. Clarke?

2 (No response.)

3 CHAIRMAN CHU: No? Thank you Dr. 

4 Clarke again for your presentation. 

5 Now we're going to move to the next 

6 agenda items. As I mentioned, we have received 

7 two requests to speak at this afternoon's meeting. 

8 As is customary, we have asked these speakers to 

9 try to restrict their statements to no more than 

10 five minutes. 

11 The first of these statements is from 

12 Doug Tonkay from the U.S. Department of Energy. 

13 Doug, are you there?

14 MR. TONKAY: Yes, I'm right here.

15 CHAIRMAN CHU: Oh you're here.

16 (Laughter.)

17 MR. TONKAY: Thank you.

18 CHAIRMAN CHU: Thank you.

19 Public Comments

20 MR. TONKAY: Yeah, good afternoon. I'm 

21 Doug Tonkay. I'm the Waste Disposal office 

22 director with the Department of Energy's 

23 Environmental Management Program, and I appreciate 

24 having the five minutes to talk. DOE is 

25 responsible for regulating low level waste disposal 
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1 facilities at sites across the country, and in 

2 doing so we have technical requirements for 

3 maintaining our performance objectives, as well as 

4 setting site-specific waste acceptance criteria at 

5 our disposal sites.

6 In addition, our directives allow 

7 utilization of commercial disposal facilities, 

8 which are directly impacted by this rule. So we 

9 have a significant interest in the changes to 10 

10 C.F.R. Part 61. I would like to thank the 

11 Subcommittee for providing the opportunity to share 

12 the views and, as well I'd like to thank the 

13 speakers for their excellent presentations.

14 Please note DOE was not given an 

15 advance copy, so we have not had time to review 

16 thoroughly all of the proposed amendments and the 

17 supporting rationale, and we would appreciate the 

18 Committee's consideration of an opportunity to 

19 provide further observations at the full Committee 

20 meeting in November.

21 In July 2015, DOE provided comments on 

22 the then-proposed revision. We are pleased that 

23 the NRC staff considered and accepted many of the 

24 comments. I want to address three areas for which 

25 we remain concerned based on our initial review of 
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1 the Federal Register notice.

2 First, as we've been discussing 

3 somewhat today, the draft final rules we understand 

4 effectively proposes a default compliance period of 

5 10,000 years for long-lived waste, with a 

6 performance objective of .25 millisieverts annual 

7 dose limit. The Commission directed and we agreed 

8 that 1,000 year compliance period be used.

9 Multiple Commissioners observed that 

10 using a 10,000 year compliance period in this 

11 context provides false comfort based on guesswork 

12 and subjective speculation. 

13 We also agree with the ACRS, which 

14 stated in their letter to the Commission that 

15 introducing significant uncertainties for the 

16 performance analysis through speculation on human 

17 activities, waste and site performance, and earth 

18 processes for a millennia is unlikely to improve 

19 either our decision-making process or our 

20 understanding of the safety decisions regarding 

21 near surface low level waste disposal. 

22 We note that the NRC regulations for 

23 materials and sites that are comparable to the near 

24 surface disposal of low level waste established 

25 compliance periods of 1,000 years at most. In 
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1 light of these considerations, we'd prefer to see a 

2 final rule with a compliance period for an annual 

3 dose limit to 1,000 years, while requiring 

4 qualitative consideration of analysis for longer 

5 time periods, up to the point of peak dose but not 

6 extending beyond the period of geologic stability.

7 Let me clarify Dr. Esh's statement that 

8 DOE has used 10,000 years for waste incidental to 

9 reprocessing analysis. This occurs because it is 

10 in an NRC NUREG guidance document that is used by 

11 the NRC technical staff that we are required to 

12 complete consultation with. It is not part of the 

13 DOE directive.

14 Our second concern is that the rule 

15 continues to include radon in the dose-based 

16 performance objectives. The inclusion of radon is 

17 inconsistent with other EPA, NRC and DOE 

18 regulations that address management of uranium 

19 containing materials. 

20 Including radon in the calculation of 

21 annual dose imposes a limit for future exposures to 

22 a limited number of hypothetical receptors, that is 

23 significantly lower than the levels currently 

24 accepted as guidelines for residential exposures 

25 across the country today.
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1 To establish more restrictive 

2 limitations in the context of an extended 

3 performance assessment that entails significant and 

4 irreducible uncertainties would be particularly 

5 unwarranted. Therefore, the final rule should 

6 exclude radon from dose calculations and instead 

7 include a performance objective with a flux 

8 standard for more consistency with other national 

9 requirements for disposal of waste containing 

10 uranium.

11 Finally, DOE suggests that a draft of 

12 the NUREG-2175 be made available for comment before 

13 the rule is finalized. The draft final rule 

14 indicates that a substantial amount of additional 

15 information ha been moved to guidance, and 

16 similarly that a large number of clarifications 

17 appear in the NUREG.

18 What information is included and how 

19 the regulatory provisions are interpreted can have 

20 a dramatic effect on implementation, particularly 

21 concerning the scope and conduct of performance 

22 assessment over extremely long time periods. While 

23 the staff indicated that changes could be made in 

24 the future, it could be many years if not decades 

25 before a revision to the guidance is available.
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1 Thank you again for the opportunity to 

2 present our views, and we will continue to monitor 

3 progress of the rulemaking, and we appreciate the 

4 opportunity to provide further observations at the 

5 full Committee meeting. 

6 CHAIRMAN CHU: Thank you very much Mr. 

7 Tonkay for your comment. We're going to go to the 

8 next comment from Roger Seitz from the Savannah 

9 River National Laboratory. He must be --

10 (Off mic comments.)

11 MEMBER BLEY: We're getting the phone 

12 line open now for you.

13 CHAIRMAN CHU: It's open?

14 MEMBER BLEY: Go ahead, yeah.

15 CHAIRMAN CHU: Mr. Seitz?

16 MR. SEITZ: Can you hear me?

17 CHAIRMAN CHU: Yes.

18 MR. SEITZ: Okay. 

19 CHAIRMAN CHU: Yeah. Please go ahead 

20 with your comments. Thank you.

21 MR. SEITZ: Okay. Thank you very much 

22 for the opportunity to speak today. Again, my name 

23 is Roger Seitz and I've been a performance 

24 assessment practitioner for more than 30 years. 

25 These comments reflect my experiences over that 
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1 time. 

2 I'd like to note that I do appreciate 

3 the efforts of the staff to address the comments, 

4 and to develop the updated materials. I previously 

5 had the opportunity to speak in detail as part of 

6 the DOE presentation for this Subcommittee, and 

7 also submitted comments.

8 So today, I'm just going to briefly 

9 summarize my thoughts on a few, but not all of the 

10 comments that have been provided. The first thing 

11 I would want to address is the time of compliance, 

12 and the change to 10,000 years for long-lived 

13 waste is a concern and also the fact that 

14 long-lived waste is not clearly defined in the 

15 rule.

16 So it's 10,000 years for long-lived 

17 waste, and then a more specific definition has been 

18 moved to the guidance. Overall, I believe 1,000 

19 years is a reasonable time frame to have strict 

20 compliance, and that's consistent with or far 

21 exceeding time frames for other U.S. rules 

22 addressing near surface disposal, noting that for 

23 deep geologic disposal there are longer times.

24 I agree with the positions of the IAEA 

25 and the ICRP that time frames after many hundreds 
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1 of years involve increasingly speculative 

2 assumptions and lose meaningfulness in terms of 

3 strict decision-making. That said, I do believe 

4 that time frames after 1,000 years need to be 

5 addressed, but in an increasingly qualitative 

6 manner with an intention to build confidence that 

7 major consequences are not going to occur later in 

8 time.

9 For example, when we -- a number 500 

10 millirem has been used. 500 millirem is still less 

11 than the average annual dose for someone in the 

12 United States today, and it's significantly less 

13 than average doses in some areas of the earth. So 

14 these things should be reasonable considerations as 

15 part of a qualitative assessment after 1,000 years.

16 The second item I will address is 

17 radon, and this is a comment that I've made several 

18 times, and I continue to be concerned that staff 

19 has departed from the well-accepted practices that 

20 exist in EPA, NRC and DOE rule. In the other 

21 rules, radon is treated as a separate performance 

22 objectives, as a flux or concentration.

23 I believe this was done because if you 

24 conducted dose assessments for acceptable 

25 concentrations of radon in a basement per EPA 
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1 guidance, those concentrations will easily result 

2 in doses well in excess of 25 millirem per year. 

3 So effectively staff are imposing a much more 

4 restrictive requirement for potential doses that 

5 may occur far in the future than are currently 

6 applied for exposures routinely occurring in many 

7 homes every day now.

8 The third thing I will address is 

9 inadvertent intrusion, and I appreciate some of the 

10 changes that helped with clarification. But I am 

11 still concerned that it's being treated as a strict 

12 performance objective. This is a departure from 

13 international recommendations that emphasize 

14 considering inadvertent intrusion in the context of 

15 optimization, rather than using a dose constraint.

16 I'm also concerned about the staff 

17 implication of the link between 500 millirems per 

18 year as the objective and how that accounts for 

19 likelihood in some respect. Note that 25 millirem 

20 per year is five percent of 500. 

21 So this leads me to think staff is 

22 implying that they believe there is reasonably a 

23 five percent chance that there will be a complete 

24 loss of control at the facility, there will be a 

25 complete loss of memory of the waste that is there.
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1 Someone will chose to move on to the 

2 footprint of the facility. They will choose to 

3 drill a well through the facility rather than to 

4 the side of the CAF, for example. They will 

5 continue drilling in spite of cuttings that are 

6 obviously not soil, grow a garden, etcetera. I 

7 would argue that the likelihood of all those things 

8 occurring is much less than five percent. So I 

9 would recommend not referring to 500 millirem as 

10 some means of addressing likelihood.

11 Finally, I would like to express 

12 concern about a potential lack of transparency by 

13 publishing a substantially revised guidance as 

14 final without public review. The staff responses 

15 to comments refer to major changes being made to 

16 the guidance, and substantial information moved 

17 into the guidance.

18 Without seeing the substantially 

19 revised guidance, it is very difficult to 

20 understand how the staff interprets this 

21 substantially changed version of the rule. I was a 

22 bit dismayed to see the staff's position that the 

23 guidance will be issued with the rule without 

24 comment, but the public can provide input and their 

25 input would be considered when the guidance is 
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1 revised.

2 Considering that Part 61 was 

3 promulgated in the early 80's, and it's just now 

4 being revised more than 30 years after the original 

5 rule, I'm left to wonder how long it might be 

6 before such a revision would occur. Thank you very 

7 much for the opportunity to speak with you.

8 CHAIRMAN CHU: Thank you very much, Mr. 

9 Seitz, for your comments. I would like to know if 

10 there are other public members who would like to 

11 make comments?

12 MR. GREAVES: John Greaves --. I'd 

13 like to make a comment if I could.

14 CHAIRMAN CHU: Yes.

15 MR. GREAVES: This is -- I'll be brief. 

16 This is John Greaves. Just as background, Paul 

17 Wellhouse and I provided specific comments during 

18 July of last year during the opening of the comment 

19 period. Paul Wellhouse was a principal author of 

20 Part 61 in the early 80's. Both Paul and I were 

21 NRC senior executive managers responsible for 

22 implementing Part 61 requirements, and developing 

23 associated guidance for over two decades.

24 After retiring a decade ago, we both 

25 provided advice to a number of national and 
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1 international organizations on low level waste 

2 disposal. 

3 My view is the staff has done a good 

4 job of listening to and incorporating many of the 

5 recommendations provided by us and others with 

6 expensive experience on implementing low level 

7 waste disposal regulations.

8 One recommendation by numerous 

9 stakeholders was a clean two-tiered approach has 

10 not been incorporated. A blended two-tiered 

11 approach has been recommended and incorporated by 

12 the staff in this proposed rule. Gary Comfort 

13 labeled it a kind of a two-tiered system, and it's 

14 not clean. It will be difficult to implement and 

15 result in unnecessary mitigation risk in my 

16 opinion. 

17 This moving target will be a 

18 significant risk with such a subjective approach 

19 that can be argued by multiple parties either way 

20 in the future. A clean two-tiered approach with 

21 1,000 year compliance period and a second tier from 

22 1,000 RPG dose approach would be adequate to ensure 

23 safety to 1,000 year compliance period and that 

24 second tier analysis as the peak dose. 

25 DOE stated a few minutes ago they used 
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1 such a two-tiered approach. This would eliminate 

2 the need for a separate, new lengthy rulemaking to 

3 address waste classification for waste streams 

4 containing larger quantities of long-lived 

5 materials. 

6 In my opinion, requiring compliance 

7 only in a guidance document in terms of specific 

8 compliance period, whether you do 1,000 or 10,000, 

9 is not an appropriate regulatory approach and 

10 unnecessary if a plainly two-tiered system is 

11 specified.

12 In my view the Commission needs to make 

13 a clear final call on the one versus ten thousand 

14 year compliance period number. It's really a 

15 policy call. Thank you for the opportunity for 

16 providing these two comments.

17 CHAIRMAN CHU: Thank you, John for your 

18 comments. Any more online? Comment? If not, I'll 

19 turn it to the floor for comments.

20 MR. ARLT: I'm with the NRC staff. I 

21 just want to make a quick comment. So my name is 

22 Hans Arlt. I was the author of part of Chapter 2 

23 of the guidance, and I just wanted to make a 

24 comment as far as like the uncertainty with regards 

25 to a site with 1,000 years and 10,000 years.
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1 The part that's in Chapter 2 looks at 

2 that. It looks at the uncertainty of the site, and 

3 it -- it has something called scenario development 

4 and conceptual model development and so forth. All 

5 the sites do not have the same uncertainty. There 

6 are certain sites that have a lot of uncertainty. 

7 If I gave you an example, say you want to build a 

8 site on the big island of Hawaii. 

9 I would not say that 1,000 years is 

10 adequate. You probably couldn't even judge the 

11 next 50 years or 100 years for a site like the big 

12 island. There are just too many uncertainties as 

13 far as like volcanos, earthquakes, the elevation 

14 it's at. It just would be a very, very bad site to 

15 build a repository.

16 Or if you're in another place, if 

17 you're like on the plains in Kansas or the desert 

18 in Chile and so forth, places that have not changed 

19 at all, the uncertainty for those areas is very, 

20 very low. Chapter 2 has a method of looking at 

21 those uncertainties.

22 So I just basically wanted to say 

23 there's no big magic line with the 1,000 years or 

24 10,000 years. You really have to look at the site, 

25 and if the site has so many uncertainties, you 
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1 know, that just might not be a good place to build 

2 it.

3 CHAIRMAN CHU: Thank you very much. 

4 Any more comments? 

5 MEMBER BLEY: Something's come up since 

6 before Madam Chairman, and I'd like to ask a 

7 question at this time if I might?

8 CHAIRMAN CHU: Sure.

9 MEMBER BLEY: Jim Clarke put something 

10 in my head here, and I went back and looked what I 

11 think is the last SRM, and I'm going to say how I 

12 read it, and then I'm going to ask you guys to 

13 comment if you would. They say to include a 

14 regulatory compliance period of 1,000 years.

15 Later they mention 10,000 years three 

16 times. Once is approving a proposal to require an 

17 intruder analysis built on the same assumptions. 

18 The second time is to do a protective assurance 

19 analysis out to 10,000 years, and the third time is 

20 to provide qualitative analysis for a performance 

21 period of 10,000 years or more.

22 As Dr. Esh talked earlier, the way I 

23 understood your discussion of the analysis at 

24 10,000 years and why seeing this build up to ten 

25 percent of the daughter products, if uranium was 
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1 significant, is almost as a sensitivity study. 

2 It's not trying to model everything that's 

3 happened, but to say gee, if we build up to this 

4 amount of radon or other daughter products, is the 

5 site still well protected?

6 The conclusion about that could well be 

7 a qualitative approach, and the rule as it's 

8 currently stated, the 10,000 years is the 

9 compliance period if you have long-lived waste, 

10 which seems different than what the Commission 

11 suggested to you. 

12 So if you guys would talk about that a 

13 little. It will probably come up at a full 

14 Committee meeting too, but I'd be interested in how 

15 you address that.

16 MR. COMFORT: Yeah. The revision, I 

17 mean the Commission provided us direction and there 

18 were a few areas from which the final rule changed. 

19 But you've got to remember that Commission 

20 direction was for the publication of the proposed 

21 rule. 

22 We incorporated what we believe all of 

23 what they directed into the proposed rule, and then 

24 part of the Administrative Procedures Act, we've 

25 got to consider all the comments that we received, 
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1 and then we made revisions based on that to what we 

2 think both is what the Commission was aiming for, 

3 as well as, you know, addresses other public 

4 comments and all. So that was the intent that we 

5 go off to, you know. We were using the 10,000 

6 years, but we're only applying it for the 

7 long-lived waste.

8 MEMBER BLEY: I have a couple more 

9 questions on this. The first is, and I think Gary 

10 you went through this earlier, I think you talked 

11 that in fact the Agreement States really urged you 

12 to have something like a 10,000 year compliance 

13 period for the long-lived waste. 

14 Did I remember that correctly, because 

15 I haven't thoroughly looked at all those comments, 

16 but I've looked at them?

17 MR. ESH: They wanted to be able to 

18 preserve their approaches.

19 MEMBER BLEY: Okay, and some of which 

20 had that or maybe --

21 MR. COMFORT: Right. They didn't 

22 specify, you know, that we should have a 10,000. 

23 They wanted the flexibility by changing the 

24 compatibility category.

25 MEMBER BLEY: Okay. I haven't had the 
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1 opportunity yet to read the final guidance. 

2 Perhaps it makes clear that these things that 

3 happened associated with 10,000 years are of the 

4 sort I talked about, and I think that was the way I 

5 interpreted the discussion you folks offered 

6 earlier, that yeah, we want some analysis to be 

7 guideposts for making determinations of the perhaps 

8 qualitatively, perhaps quantitatively, of the 

9 capability of the site.

10 And I'll have to read it and see. But 

11 would you tell me that that in fact is the case?

12 MR. ESH: Right, yes. So the objective 

13 of those analyses is to provide the information for 

14 the regulatory decision-making about whether public 

15 health and good -- public health and safety is 

16 protected for the disposal action that you want to 

17 take. So --

18 MEMBER BLEY: And they're not intended 

19 to be models of the future?

20 MR. ESH: Well that --

21 MEMBER BLEY: --under all capabilities.

22 (Simultaneous speaking.)

23 MR. ESH: This is the problem. So 

24 people will talk about this process that you're 

25 doing a forecast. I wouldn't call it a forecast at 
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1 all. You are doing a regulatory analysis to 

2 justify this regulatory decision or action that you 

3 want to make, and maybe I'm splitting hairs about 

4 that. But they are not forecasts. They are not 

5 projections. 

6 Sure, you're generating dose 

7 assessments into time. But it's not the same thing 

8 as like trying to say well, what's the population 

9 growth over the next five years, or who's going to 

10 win the election, you know? Those are true 

11 forecasts and projections.

12 This is an analysis over time, but it's 

13 -- we never describe or try not to ever describe 

14 them as forecasts. So and the idea that for the 

15 material that we were directed to address in this 

16 rulemaking, the depleted uranium, that you should 

17 only analyze it for 1,000 years and then cut it

18 off, I don't know why you would describe that as a 

19 risk-informed approach.

20 How by not calculating what you think 

21 is going to happen is that risk-informed? I 

22 realize there are uncertainties associated with the 

23 calculations and what's happening over time. But 

24 that's the information that you should be 

25 considering as a decision-maker, not missing, 
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1 especially when the thing that you know most in 

2 these problems are the waste characteristics.

3 You know, I mean the decay and ingrowth 

4 characteristics. The radiation physics is the part 

5 of this that we should have the most certainty 

6 about. So if we know things about the radiation 

7 physics, then that should reflect into the 

8 approaches that we're trying to do, which is what 

9 we're doing with this tiered approach to the 

10 compliance period. We're trying to bring in the 

11 radiation physics into how we solve the problem.

12 MEMBER BLEY: Okay. This is starting 

13 to fit together for me, and I look forward to 

14 reading the guidance. I'd just mention, you know, 

15 if you look at Reg Guide 1.174, when it looks at 

16 things like this it has you do the best 

17 calculations you can, but talks about an integrated 

18 decision-making process. I think you're talking 

19 the same kind of thing here.

20 MR. ESH: Right, and I think it was 

21 maybe one of the ACRS meetings where I had some 

22 figures or slides on performance assessments and 

23 results, and you know. You can have a situation 

24 where your numerical model or calculation generates 

25 a number that's well below your limit, and as a 
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1 regulator I could still say you didn't make a 

2 safety case because it's based on the quality of 

3 the information and what went into the assessment 

4 to get you from here to there.

5 Likewise, you could have a situation 

6 where maybe you generate a result, a probabilistic 

7 result and some of the results are above your limit 

8 and I could say look, you've still made the 

9 criteria because you had a lot of conservatisms and 

10 this, that or the other thing that went into the 

11 calculation.

12 So too much is hung up on generating 

13 numbers and comparing numbers, instead of what 

14 this is about is developing all the information to 

15 build some confidence that you're making a correct 

16 decision, of which the numbers are one input to 

17 that.

18 Like I said earlier, you know, waste 

19 characteristics in those prohibitions and 

20 restrictions is probably much more important than 

21 whether you've analyzed 1,000 years or 10,000 years 

22 for your compliance period. 

23 I mean if you look at the Beatty, 

24 Nevada case, they had the site catch on fire and 

25 barrels blew out of it because they apparently had 
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1 put metallic sodium in it and then they got a bunch 

2 of water that interacted with the sodium and blew 

3 the barrels out.

4 Okay. Maybe if they had followed the 

5 waste characteristics more closely, they could have 

6 avoided that problem. That actually is a good 

7 example because the only reason why that didn't 

8 turn into a significant impact is because in the 

9 location where that occurred, there wasn't a lot of 

10 activity remaining. If there had happened to be 

11 some long-lived waste in the vicinity of where that 

12 happened, there at least would have been an 

13 expensive cleanup to deal with, if not health and 

14 safety impacts. 

15 I don't know. We appreciate all the 

16 input we have from the commenters, and we realize 

17 we differ from some of the commenters in the 

18 approach and the opinions. 

19 I would indicate that I don't believe 

20 the guidance, I would call it, was revised 

21 significantly. So we did make the changes to the 

22 guidance that we needed to in response to the 

23 changes in the regulation, and other ancillary 

24 changes to the guidance.

25 But I certainly wouldn't characterize 
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1 it as a significant revision. The most significant 

2 thing is we dropped Chapter 6, which was the 

3 protective assurance period analyses because we 

4 took that out of the rule. So if you're talking 

5 big changes, that's the biggest change. A lot of 

6 the other material remained the same in the draft 

7 that was provided for comment.

8 So and many of the other comments that 

9 you heard at the end here, they're similar to the 

10 comments that were provided in writing and that 

11 we've generated responses to. 

12 So if you're curious what our responses 

13 would be to those questions, I know we're running 

14 late tonight. Look at those between now and the 

15 final committee meeting and we'll be happy to come 

16 back to them when we get to that point.

17 MEMBER REMPE: If we have discussion of 

18 this at our November meeting, and this document 

19 still has not been released, will we have a closed 

20 meeting?

21 MR. WIDMAYER: Do you want an answer? 

22 We have been able to close certain portions of full 

23 Committee meetings. We have to check with OGC and 

24 find out if --

25 MEMBER REMPE: Well that's my question, 
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1 is we can't discuss it openly. If we have 

2 questions about what's in here, it's not been 

3 released to the public and I think you've said the 

4 reason it's not been released is the Commissioners 

5 want to see it because it might affect some of the 

6 rule language, and that's why it's not been 

7 released. Is that a correct paraphrase of your --

8 MR. COMFORT: No. The Commission 

9 doesn't actually look at it specifically. It's 

10 more because we won't want to have a bunch of 

11 variations going around, that there could be some 

12 document -- you know, people saying oh, you 

13 released this back in September or whatever. This 

14 is what I'm using. Oh, what do you mean you 

15 changed it, you know. It's just version tracking 

16 control --

17 MEMBER REMPE: But something in the 

18 2125 could impact what's in the rule that might be 

19 published; is that true?

20 MR. COMFORT: No. The Commission could 

21 though change and direct -- change direction of 

22 what we want to do in some ways that we'd have to 

23 update --

24 (Simultaneous speaking.)

25 MEMBER REMPE: In the 2125 guidance --
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1 MR. COMFORT: Right. Well, in our rule 

2 and then we'd have to update --

3 MEMBER REMPE: In the rule.

4 MR. COMFORT: Right.

5 (Simultaneous speaking.)

6 MR. COMFORT: Yeah. 

7 MEMBER REMPE: Okay. That's what I 

8 thought you said.

9 MR. COMFORT: Right, yeah. If the 

10 Commission changes something in the rule, then we 

11 would update 2125?

12 MEMBER REMPE: And they might do that?

13 MR. COMFORT: Yeah, and if they don't 

14 make any changes, then what you see as the guidance 

15 would be going forward. And the Commission could 

16 always make the decision, I mean if they get public 

17 interest to say go release it anyways, you know. 

18 We're not going to worry about the version control 

19 issues. That's up to the Commission direction. We 

20 follow Commission direction.

21 MR. ESH: Yeah. Let's look at that. 

22 Let's take that back and get back to the Committee 

23 about -- so we haven't issued, released the 

24 guidance because, just as Gary's said, the rule is 

25 just the staff's proposal to the Commission. If 
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1 the Commission changes the rule, we'll have to make 

2 conforming changes to the guidance.

3 But I need to talk to our general 

4 counsel and our rulemaking staff. But to me, it 

5 seems like the draft guidance is consistent with 

6 the draft final rule, which is with the Commission. 

7 So I'm not sure what the pre-decisional argument 

8 would be at that point. But let us explore that 

9 and get back to you.

10 MEMBER BLEY: This is something we have 

11 to know about very, very, very quickly. I mean 

12 like tomorrow quickly. We have -- we're down to 

13 two weeks and a day or something like that, and we 

14 have to get our FRN out. If we should have to 

15 close part of the meeting, we have to include that. 

16 I suspect if OGC gets involved and we pursue this a 

17 little, closing a FACA meeting for pre-decisional 

18 material could get pretty dicey.

19 MR. WIDMAYER: Yeah. That doesn't 

20 usually happen.

21 MEMBER BLEY: Doesn't usually work.

22 MR. WIDMAYER: What we've done in the 

23 past with a similar situation is staff generated a 

24 version of the guidance document that had draft as 

25 a watermark on every page, and indicated what it 
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1 was as far as timing goes, and then it was clear 

2 that it wasn't going to necessarily be a final 

3 guidance document. The issue was whether or not 

4 the Commissioners had a chance to look at it, even 

5 in its draft form.

6 MEMBER REMPE: The guidance document. 

7 Not just the rule but the guidance document. 

8 MR. WIDMAYER: Right and they, as the 

9 staff indicated, they don't typically look at the 

10 guidance. So it should be okay with the Commission 

11 for us to have the open meeting.

12 MEMBER BLEY: I hope you guys can 

13 really pursue this right away tomorrow and get back 

14 to us like before noon. If this thing has draft 

15 across every page, that's also a problem because I 

16 have -- some of us have trouble reading that type 

17 of -- me in particular.

18 MEMBER STETKAR: It's also difficult 

19 for the ACRS. If the ACRS had comments on -- well, 

20 I guess we could have comments on something that's 

21 not.

22 MEMBER BLEY: It's possible. It would 

23 be good to see that called final and let us look at 

24 it, even if it's not published yet.

25 MR. WIDMAYER: Well, it won't be final.
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1 MR. COMFORT: Right.

2 MR. ESH: Right.

3 MR. WIDMAYER: Because we're not going 

4 to finalize the guidance until the Commission 

5 approves the rule.

6 MR. ESH: Right.

7 MR. WIDMAYER: But what we can explore 

8 is can we make that draft conforming, consistent 

9 with what was offered to the Commission, if we can 

10 make that public, and that's what I want to explore 

11 with OGC and the rulemaking staff.

12 MR. COMFORT: Well we're -- it's 

13 really the issue is I mean it hasn't gone through 

14 all our formal management concurrence and OGC 

15 concurrence yet, that there may be tiny little 

16 tweaks of a word here and there, but the concepts 

17 are all there, that you're going to see that 

18 nothing technical is going to change.

19 Whether we can discuss it in 

20 generalities I mean in a public meeting, because it 

21 supports the rule, I mean you're just really 

22 talking about the rule and how you're going to 

23 implement it and how, you know, one phase. The 

24 only thing is other members of the public wouldn't 

25 have seen it if we don't release it. And while we 
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1 can't discuss it --

2 MEMBER BLEY: You bring up something I 

3 was going to hold until you go around the table, 

4 but I'm going to say it now.

5 CHAIRMAN CHU: Okay.

6 MEMBER BLEY: As Chairman of the ACRS. 

7 I want to -- I know you want a letter that supports 

8 the rule and the guidance. We got the guidance 

9 today and we still have this other thing going on. 

10 In the past year, there was a case very similar to 

11 this. We wrote a letter endorsing the rule but 

12 told the Commission we could not yet endorse the 

13 guidance for different reasons. 

14 But we did that. That's a possibility 

15 no matter what happens because we've had such short 

16 time to look at this. The other possibility is we 

17 have -- we read through it and we have a good 

18 enough full committee meeting that we feel we can 

19 include it in the letter. I was going to bring 

20 this up later but I'll bring it up now for you, 

21 Madam Chairman. 

22 We were scheduled for a two hour full 

23 Committee meeting. Since we've not had a 

24 Subcommittee meeting on the guidance with us having 

25 had a chance to review the guidance, it seems to me 
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1 you might want to have a longer full Committee 

2 meeting. What I was thinking was we could make 

3 this the third one on the first day of the meeting, 

4 and schedule it for four hours. 

5 If it doesn't take that long that's 

6 great, and if it does because we've got to dig into 

7 this, and as we go through the guidance, it's also 

8 possible we might have real disagreements with it. 

9 We don't know yet. I mean the way David walked us 

10 through it, it sounds pretty good. But that's not 

11 the same as reading it and thinking about it.

12 CHAIRMAN CHU: Dennis, you're saying in 

13 the full Committee, we spend a lot of time going 

14 through the guidance document. Is that what you're 

15 saying?

16 MEMBER BLEY: If the staff wants us to 

17 include review of the guidance document in our 

18 letter, I don't see how you avoid that, since we 

19 haven't -- we will not have read it until then.

20 CHAIRMAN CHU: Are we going to have 

21 time to write the letter, you know, 24 hours later?

22 MEMBER BLEY: Well, that's up to you. 

23 That's up to you.

24 MEMBER REMPE: But the Commission has 

25 told ACRS not just to review the rule, but also to 
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1 review the guidance, right?

2 MR. WIDMAYER: Yes. They encouraged 

3 you to --

4 MEMBER BLEY: That's almost irrelevant 

5 at this point. We will review it. Whether we 

6 review it to support a letter in November is what 

7 I'm talking about. We didn't get it a month before 

8 then, and it's going to be pretty hard to fit it 

9 all in.

10 (Simultaneous speaking.)

11 MEMBER STETKAR: I like the analogy 

12 that you brought up in that other case, where we 

13 just told them we're going to review the guidance 

14 later, and we haven't done that yet in that 

15 particular case.

16 MEMBER BLEY: I thought we did.

17 MEMBER STETKAR: Well, we wrote a 

18 letter on it. There's still open issues.

19 MEMBER BLEY: Oh yeah, open issues.

20 MEMBER STETKAR: There's still open 

21 issues. They're coming back to us some time.

22 CHAIRMAN CHU: But my question is --

23 MEMBER BLEY: What do you do?

24 CHAIRMAN CHU: Why write a letter in 

25 November? Can we --
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1 MEMBER BLEY: Because the staff has 

2 asked us to. That's --

3 CHAIRMAN CHU: That's my question, is 

4 does it make more sense if we review the guidance 

5 documents between now and November some time, and 

6 then the full Committee actually comes in December 

7 and we write a letter in December that's 

8 comprehensive and we reviewed everything. We got 

9 all the information, you know, rather than I have 

10 12 hours to make a decision. That's just an option 

11 that I want people to think about.

12 MR. COMFORT: Can I just make the point 

13 that I mean it's really not totally up to us. This 

14 document is before the Commission. I mean they can 

15 make a vote any time they want and, you know, the 

16 earlier that you provide input for that so that 

17 they can kind of assimilate that. If they're 

18 willing to wait longer, that's up to the 

19 Commission. But I just want to --

20 MR. WIDMAYER: Our timing right now is 

21 sensitive to the timing of the Commission. This 

22 paper is with them right now. The SECY paper is 

23 with them to make a decision whether to have the 

24 staff move forward and publish this as a final 

25 rule. The more this committee delays, the less 
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1 likely they are to have your letter in time to help 

2 with their decision.

3 CHAIRMAN CHU: But if we rush, we're 

4 not going to have the information in the letter.

5 MEMBER BLEY: Well, we can certainly 

6 write a letter on the rule.

7 CHAIRMAN CHU: Right, right. Is that 

8 --

9 MEMBER BLEY: And we can, you know, if 

10 I were you I would prepare the beginning of a 

11 letter on the rule, and have the Subcommittee help 

12 you with that. As we review the guidance, we can 

13 decide whether we'll be able to say anything 

14 positive or not about it. 

15 MEMBER STETKAR: Why don't we -- the 

16 purpose of the Subcommittee is to bring things to 

17 the full Committee.

18 MEMBER BLEY: The full Committee.

19 MEMBER STETKAR: So why don't we go 

20 around the Subcommittee and see if we'd like to 

21 recommend to the full Committee that we postpone a 

22 review of the guidance?

23 MEMBER BLEY: I think at this point, 

24 you could go around the table for everything, get 

25 comments on everything.
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1 (Simultaneous speaking.)

2 CHAIRMAN CHU: Yeah. 

3 Subcommittee Wrap-Up and Discussion

4 MEMBER REMPE: I want to start off by 

5 thanking the staff, and I do believe that you've 

6 answered a lot of questions and that you've spent a 

7 lot of time trying to deal with this issue. 

8 However, I am stuck on Commissioner 

9 guidance that said we need to look at the rule and 

10 the guidance. I'm stuck on the fact that the 

11 guidance was just given to us today. We didn't 

12 have a chance to go through it and implementation 

13 of the rule, which is in the guidance, could affect 

14 my thoughts about the rule.

15 Hence, despite the fact -- I mean I 

16 would be happy to send the Commissioners a 

17 valentine or mailgram saying we didn't get this in 

18 time. We'll talk to you next December. Why don't 

19 you wait until we get a chance to talk, to have a 

20 thorough evaluation?

21 So I'm with what Margaret is suggesting 

22 that -- I mean we can send them a note or we can 

23 call them and contact them. But I don't think we 

24 should be providing comments on the rule when we've 

25 not had a chance to discuss the guidance. Thank 
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1 you.

2 CHAIRMAN CHU: Thank you. Charlie?

3 MEMBER BROWN: Yeah. I don't have any 

4 other comments, other than one on this, is that I 

5 -- am I interfering? Pardon?

6 MALE PARTICIPANT: You're okay.

7 MEMBER BROWN: Okay. I have a little 

8 bit of difficulty understanding how you can issue 

9 guidance without ever having the public and the 

10 people who have utilize it even see it. That just 

11 seems to go against my sense of whatever sense I 

12 should have.

13 I mean I don't know why you just don't 

14 publish it and just don't put the drafts on the 

15 thing but put pre-decisional up at the top on every 

16 page, and let the public see it, and then they can 

17 see what's going on. Because right now, that's 

18 just my opinion, okay.

19 MR. ESH: Can I add though that the 

20 guidance was made publicly available, and it had 

21 the same public comment period as the rule? That's 

22 the -- I mean the way the process works is that was 

23 the proposed rule and the proposed guidance. So we 

24 received all the comments, make changes, and then 

25 we issue a final document, the final rule and the 
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1 final guidance.

2 MEMBER BROWN: That's the same that 

3 they made comments on?

4 MR. ESH: That's the final draft of the 

5 final guidance document.

6 MEMBER BROWN: But is it the same? Is 

7 it --

8 MR. ESH: It is not the same, but how 

9 do you ever get out of the public comment loop if 

10 you always submit something for public comment 

11 then? So if you submit that document, you're going 

12 to get new comments. Then what do you do, change 

13 the document and then you have to submit it again?

14 MEMBER BLEY: I'm sorry. This isn't --

15 this isn't a time for discussion with the staff. 

16 But the process we always see is one where the 

17 staff publishes guidance, gets comments and 

18 prepares the final that includes responses to all 

19 the comments. 

20 That's just the way, and then they 

21 don't go out again unless there's massive changes 

22 that really upset things. In any of their guidance 

23 documents that I've been aware of since I've been 

24 here.

25 CHAIRMAN CHU: Jose.
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1 MEMBER MARCH-LEUBA: Yes. Maybe you 

2 have noticed I'm not an expert of this field, so I 

3 have been mostly quiet. But I have listened to

4 David and I have agreed with essentially every one 

5 of your arguments. I really appreciate what you 

6 said. But I sense a lot of pushback on a couple of 

7 topics. The 10,000 years and the radon.

8 So if you could prepare one slide or 

9 two on that for the full Committee for my 

10 education. What is the implication of doing the 

11 10,000 year analysis? Why is people opposed to it, 

12 and what would be the rationale of taking radon as 

13 a different isotope than any of the others? 

14 Is it because we don't have good models 

15 for it? So if you could educate me on that one in 

16 a couple of weeks, I would appreciate it.

17 MR. ESH: Certainly.

18 CHAIRMAN CHU: John.

19 MEMBER STETKAR: Nothing, thank you.

20 (Off mic comment.)

21 MEMBER BLEY: Not even going to help on 

22 the decision about the letter?

23 MEMBER STETKAR: Well, I thought --

24 (Off mic comment.)

25 MEMBER STETKAR: I thought we were 
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1 going to just go around and ask. Nobody else --

2 MEMBER BLEY: Charlie did.

3 MEMBER STETKAR: Okay. Well my 

4 recommendation would be that we bring the rule to 

5 the full Committee, and that we recommend that we 

6 did not hear anything on the guidance. If nothing 

7 else, the full Committee, as best as I can tell, 

8 isn't here and they haven't received the guidance 

9 and it's now about two weeks before the full 

10 Committee meeting, which is well under our 30 days 

11 time for transmitting material to the full 

12 Committee and expecting --

13 I've been told, I haven't loaded the 

14 CD, that it's several hundred pages?

15 MALE PARTICIPANT: 500 pages.

16 MEMBER STETKAR: 500 pages? There's no 

17 way that you can expect, you know, our other 

18 committee members to try to do any type of 

19 meaningful review of that material in two weeks, 

20 given everything else we have to do. So that would 

21 be my recommendation.

22 CHAIRMAN CHU: Dennis.

23 MEMBER BLEY: Yeah. First, I see no 

24 reason why we don't draft a letter on the rule. I 

25 think we not only should but we have to, to serve 
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1 the Commission in the way they've asked us to, and 

2 we've had the rule for a fair time now and we've 

3 had a very good discussion today on it.

4 I'm not as -- I mean there have been 

5 times in the past where we have fit in things at 

6 this late a date, but nothing with this much 

7 material in it. If we're going to -- I don't mean 

8 to ramble on here -- if we're not going to try to 

9 include the guidance in the letter and we're not 

10 going to use a couple of hours in the full 

11 Committee to have a briefing on the guidance, 

12 we'll need another Subcommittee as soon as we can 

13 to look at the guidance, some time late November or 

14 early December if possible.

15 But we'll have to look at what's 

16 feasible. Our Subcommittee agenda is pretty full 

17 right now. We have to look at that. We don't have 

18 the full Committee here to make a choice, but as a 

19 subcommittee I'd lean toward trying it. 

20 But I haven't read it yet, so I won't 

21 know for a week whether that's even remotely 

22 feasible and whether the briefing we got today 

23 covers it at anywhere near the level we would have 

24 wanted to dig into it. That's the best I can do.

25 CHAIRMAN CHU: Well, I have voiced my 
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1 preference is to review everything, okay, the rule 

2 and the reg guide -- and the guidance document if 

3 possible. But my question is if we only write a 

4 letter on the rule, does that mean we have to write 

5 another one?

6 MEMBER BLEY: Yes.

7 CHAIRMAN CHU: So it will be another 

8 one.

9 MEMBER BLEY: Yeah, and if we write a 

10 letter on both, two or three things have to happen. 

11 We have to make a longer full Committee meeting, 

12 which I will do. We have room to put it in as a 

13 four hour meeting. The staff has to clarify the 

14 status of this document to support the review by 

15 tomorrow some time. 

16 But I misunderstood you earlier. I 

17 thought you didn't want to include this guidance in 

18 the letter.

19 CHAIRMAN CHU: Well if we didn't review 

20 it, then we can't include it. That's my point.

21 MEMBER BLEY: Yeah, and our time to 

22 review it is two weeks plus the full Committee 

23 meeting.

24 CHAIRMAN CHU: I'm going to ask David a 

25 question. I used to do performance assessments. 
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1 So I think a lot of things are in the details, how 

2 do you implement it, and then I believe most of 

3 that is in the guidance document, right? So my 

4 point is if we don't read it, are we going to miss 

5 something important for the rule? That's what I'm 

6 afraid, okay, is say -- because they're kind of 

7 linked, you know.

8 The guidance tells you what 

9 the rule really asking the licensee to do, and then 

10 what kind of bothers me a little bit is say we 

11 approve the rule, but we haven't looked at the 

12 implementation. Is that okay not to look at it and 

13 then approve the rule? 

14 MR. ESH: Well, the rule has to stand 

15 on its own merits and the technical content that's 

16 in there, along with the statement of 

17 considerations that goes along with it. So while 

18 the guidance does provide information associated 

19 with implementation, my opinion is you could look 

20 at the rule --

21 CHAIRMAN CHU: Independently?

22 MR. ESH: Independently of the 

23 guidance. You could also just take my opinion and 

24 write that the guidance is very good.

25 (Laughter.)
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1 MR. WIDMAYER: That was summarily 

2 rejected.

3 MEMBER STETKAR: In the past, we've 

4 also taken -- well I have anyway, because it's a 

5 subcommittee meeting, the position that the rule 

6 ought to be very clear on what should be done. The 

7 guidance tells you how to accomplish it, and the 

8 rule ought not to be held hostage to the how to 

9 accomplish it part of it.

10 In that sense, as we did in this other 

11 kind of ongoing example right now, it should be 

12 possible for the ACRS to reach conclusions 

13 regarding the rule language, without being held 

14 hostage to the implementation guidance. I mean if 

15 the rule language is that dependent on the 

16 implementation guidance, it seems there's a 

17 problem.

18 MEMBER BLEY: I'm going to clarify my 

19 recommendation. I'm going to recommend that in 

20 fact at the next meeting we have a four hour 

21 session and we have at least two hours devoted to 

22 the guidance. Whether or not at that time we can 

23 decide we're ready to write or not on the guidance, 

24 we'll decide then.

25 We have the previous guidance. We've 
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1 had it for a long time. We reviewed it two years 

2 ago and personally I don't know how much has 

3 changed. It sounds like a lot of it's pretty 

4 similar, which would make our reviewing easier, 

5 except for some of us haven't been here for that 

6 other meeting.

7 MR. ESH: Crea's (phonetic) "please 

8 read me" file, that will be useful, because that 

9 focuses you on the delta from the previous version 

10 to this version.

11 CHAIRMAN CHU: I'm going to sort of 

12 change the subject a little bit and make a comment 

13 about 10,000 years. Personally, it doesn't bother 

14 me. Maybe it's because I just don't know how to 

15 perform this assessment. 

16 But I look at the value is you are 

17 forcing the licensees to go through this quite 

18 rigorous or comprehensive process, to look at all 

19 the things that could possibly happen at your site 

20 and your environment, and then up until a time you 

21 feel that you have a little bit of control, because 

22 of the radioactivity, okay.

23 And so to me, I think it's similar to 

24 what you say. It's not the answer itself, but it 

25 is the process you go through so you know your site 
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1 well, okay. You know your engineer barriers, you 

2 know the long-term geological change that might 

3 occur. All these things that otherwise a licensee 

4 wouldn't look at it rigorously. To me that's the 

5 value.

6 So and then like you said, it's 1,000 

7 year or 10,000 year, the cranking of the computer 

8 is nothing, okay. You just keep cranking for 

9 another 9,000 years. But it's looking at all the 

10 things and you have to justify what you present to 

11 the NRC, the evaluator of why you pick what you 

12 pick. That's the value I feel. So 10,000 years 

13 doesn't bother me. Just my personal opinion. 

14 MEMBER SKILLMAN: I want thank David 

15 and Gary for a very thorough presentation. This 

16 represents a huge amount of work. Thank you. I 

17 also want to respect the four individuals that made 

18 comments. So thank you. I have nothing further to 

19 add. I'm aligned with Joy and with John. I 

20 believe we could write a letter, we could write a 

21 letter on the rule. 

22 Until we see the guidance, I think we 

23 should be careful. A four hour meeting would allow 

24 us to creep up on that. But I think we should be 

25 very cautious before we commit to writing anything 
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1 regarding the NUREG. But I do believe we can look 

2 at the rule from the perspective of overarching 

3 guidance, as opposed to how to. Thank you.

4 CHAIRMAN CHU: Walt?

5 MEMBER KIRCHNER: Thank you. Thank the 

6 staff for their very good presentations. I think 

7 I'm in Dick's camp and several others. I think we 

8 could -- the rule should stand on its own, and 

9 therefore I think we could be in a position with 

10 the next full Committee meeting to write a letter 

11 on the rule.

12 I sure would like to look at the 

13 guidance of why and maybe reserve comment until 

14 everyone has more opportunity to review it 

15 thoroughly. There were a couple of areas that 

16 hopefully maybe we could ask the staff to address. 

17 We heard comments on radon-related 

18 dose, and also I thought I understood the rationale 

19 for the 500 millirem per year dose for the 

20 intruder, but if that could be addressed again in 

21 the full Committee, I would appreciate hearing that 

22 again.

23 It seems to me to be an important 

24 addition to the rule, and I'm not sure I 

25 thoroughly, being new to this area, ingested the 
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1 rationale behind that. Thank you.

2 MEMBER BLEY: One clarification. I 

3 think Derek's going to circulate the old white 

4 paper to the full Committee, yeah.

5 CHAIRMAN CHU: Any other comments?

6 (No response.)

7 CHAIRMAN CHU: Thank you very much. I 

8 thought the presentations were excellent.

9 MEMBER BLEY: Meeting adjourned.

10 (Whereupon, the above-entitled matter 

11 went off the record at 5:59 p.m.) 
DOE Remarks Regarding NRC Staff Revisions to Draft Final 10 CFR Part 61 (October 18, 2016) --

Revised as given

Good afternoon, I am Douglas Tonkay, the Waste Disposal Office Director with the Department of 

Energy’s Office of Environmental Management. DOE is responsible for regulating low-level waste 

disposal facilities at sites across the country. In doing so we have technical requirements for

maintaining our performance objectives as well as setting site-specific waste acceptance criteria at our 

disposal sites. In addition, our directives allows utilization of commercial disposal facilities, which are 

directly impacted by this rule. So, we have significant interest in any changes to 10 CFR Part 61. 

I would like to thank the Subcommittee for providing the opportunity to share DOE views on the NRC 

staff’s draft final rule. Please note that, DOE was not given an advance copy, so we have not had time 

to review thoroughly all of the proposed amendments and their supporting rationale. We would 

appreciate the opportunity to provide further observations at the full Committee meeting in November.

In July 2015, DOE provided comments on the then proposed revision. We are pleased that the NRC staff 

considered and accepted many of our comments. I want to address three areas for which we remain 

concerned based on our initial review of the Federal Register notice. 

First, the draft final rule, as we understand it, effectively proposes a default compliance period of 10,000

years for long-lived waste with a performance objective of 0.25 mSv annual dose limit. The Commission 

directed, and we agree, that a 1,000-year compliance period be used. Multiple Commissioners observed 

that using a 10,000-year compliance period in this context “provides false comfort . . . [based] on 

guesswork and subjective speculation”. We also agree with the ACRS, which stated in a letter to the 

Commission that, “Introducing significant uncertainties to the performance analysis through speculation 

on human activities, waste and site performance, and earth processes for millennia is unlikely to 

improve either our decision making process or our understanding of the safety decisions regarding near 

surface [low-level waste] disposal.” We note that NRC regulations for materials and sites that are 

comparable to near-surface disposal of low-level waste establish compliance periods of 1,000 years at 

most. In light of these considerations, we prefer to see a final rule with a compliance period for an 

annual dose limit to 1,000 years, while requiring qualitative consideration of analyses for longer time 

periods, up to the point of peak dose but not extending beyond the period of geologic stability. Let me 

clarify Dr. Esh’s statement that DOE has used 10,000 years for Waste Incidental to Reprocessing analysis. 
This occurred because it is in NRC NUREG guidance used by NRC technical staff and we are required to 

complete consultation with them. It is not a DOE directive.

Our second concern is that the rule continues to include radon in the dose-based performance 

objectives. This inclusion of radon is inconsistent with other EPA, NRC, and DOE regulations that 

address management of uranium-containing materials. Including radon in the calculation of annual 

dose imposes a limit for future exposures to a limited number of hypothetical receptors that is 

significantly lower than the levels currently accepted as guidelines for residential exposures across the 

country today. To establish more restrictive limitations in the context of an extended performance 

assessment that entails significant and irreducible uncertainties would be particularly unwarranted. 

Therefore, the final rule should exclude radon from dose calculations and instead include a performance 

objective with a flux standard for more consistency with other national requirements for disposal of 

wastes containing uranium. 

Finally, DOE suggests that a draft of NUREG-2175 be made available for comment before the rule is 

finalized. The draft final rule indicates that a substantial amount of additional information has been 

moved to guidance, and similarly, that a large number of “clarifications” appear in the NUREG. What 

information is included and how the regulatory provisions are interpreted can have a dramatic effect on 

implementation, particularly concerning the scope and conduct of performance assessment over 

extremely long time periods. While the staff indicated that changes could be made in the future, it 

could be many years, if not decades, before a revision to the guidance is available.

Thank you again for the opportunity to present our views. DOE will continue to monitor progress of the 

rulemaking and would appreciate the opportunity to provide further observations at the full Committee

meeting.
Dr Chu, thank you for the opportunity to make comments. I will be brief. I, [John Greeves] and Paul 

Lohaus provided specific comments during the public comment period 7/24/2015.

Paul L. was a principal author Part 61 in the early 80’s. Both Paul and I were NRC SES managers 

responsible for implementing Part 61 requirements and developing the associated guidance for over 

two decades. After retiring a decade ago we both provided advice to a number of national and 

international organizations on LLW disposal activities.

The staff has done a good job of listening to and incorporating many of the recommendations provided 

by us and others with extensive experience with implementing LLW disposal regulations.

One recommendation by numerous stakeholders for a clean two-tiered approach has not been 

incorporated.

A blended two-tiered analysis has been recommend and incorporated by the staff. 

A “kind of a two tier system” [as labeled by Gary Comfort earlier today] is not clean; it will be difficult to 

implement and will result in unnecessary litigation risk. This moving target will be a significant risk with 

such a subjective approach that can be argued by multiple parties either way.

A clean two-tiered (i.e.; 1,000y compliance period; a tier-2 1,000y-to-peak dose) approach would be 

adequate to ensure safety through a 1,000 year compliance period, and second tier analysis out to peak 

dose. DOE uses such an approach two-tiered approach.

This would eliminate the need for a separate new lengthy rulemaking to address waste classification for 

waste streams containing large quantities of long lived material.

I would add, in my opinion, requiring compliance, pointing at a “guidance document” to determine a 

specific compliance period (either 1,000 vs. 10,000) is not an appropriate regulatory approach, and 

unnecessary, if a clean 2-tier system is specified. 

The Commission needs to make a clear final call, on this 1 vs. 10k y compliance period number. It is a 

policy call.

Thank you for the opportunity to provide these few comments.
10 CFR Part 61

“Low-level Radioactive Waste Disposal”

Final Rule

Gary Comfort

Senior Project Manager

United States Nuclear Regulatory Commission

Presented to the ACRS Radiation Protection 

and Nuclear Materials Subcommittee

October 18, 2016
Discussion Topics

• Purpose and History

– Overview

– Commission Direction

– Past ACRS Interactions

• Proposed Rule Comments

• Draft Final Rule 

• Technical Elements

• Path Forward

2
Purpose of Rule

Problem: Ensuring safe disposal of new 

waste streams not analyzed as part of 

original 10 CFR Part 61 regulation

• Depleted uranium (DU)

• Blended wastes

• Future waste streams

3
Purpose of Rule

Objectives

• Specify site-specific analyses requirements

• Reduce ambiguity and facilitate implementation

• Better align with existing health and safety 

standards

4
Commission Direction

• Order CLI-05-20

– Staff directed to consider disposal of DU

• SRM-SECY-08-0147

– Directed rulemaking to require site-specific analysis 

for disposal of large quantities of DU and associated 

technical criteria

– Develop supporting guidance

– Maintain the waste classification of depleted uranium

5
Commission Direction

• SRM-SECY-10-0043

– Incorporate blending into rulemaking

• SRM-COMWDM-11-0002/COMGEA-11-0002

– Allow licensee flexibility to use ICRP dose methodology

– Use two-tired approach with compliance period covering 

reasonably foreseeable future and longer period of 

performance

– Allow flexibility to establish waste acceptance criteria 

based on site-specific technical analyses

– Establish compatibility to ensure alignment between States 

and Federal government

6
Commission Direction

• Staff provided proposed rule to Commission in 

SECY-13-0075

– Latest rule language ACRS reviewed

• SRM-SECY-13-0075 

– Directed numerous significant changes

– Directed publication after changes made

– ACRS encouraged to provide independent review and 

recommendations on the technical basis and the 

accompanying draft guidance

7
Commission Direction

8

Comparison of Draft Rule in SECY-13-0075

and Published Draft Rule

SECY -13 -0075

Analysis Time Frames (2 – tier)

Performance Assessment

Waste Acceptance Criteria

Updated ICRP Dosimetry Modeling

Compatibility Category C

Intruder Assessment

Publication

Analysis Timeframes (3 – tier)

Performance Assessment

Intruder Assessment

Explicit Description of Safety Case

Defense In Depth (DID) Analysis

Site Stability Analysis

Waste Acceptance Criteria

Updated ICRP Dosimetry Modeling

Compatibility Category B

= Minor change resulting from SRM Direction = Major change resulting from SRM Direction
ACRS Interactions

Meeting Dates

Subcommittee Full Committee

December 16, 2009 March 4, 2010

June 23, 2011 July 13, 2011

August 17, 2011 September 8, 2011

April 9, 2013 July 10, 2013

9
ACRS Letter Reports –

Key Issues

• Risk-informed based on site-specific, realistic 

performance assessments with consideration for 

uncertainties

– Realistic assumptions for release and fate and transport of 

DU

– Realistic likelihood of intrusion

– Range of site-specific conditions

• Use timeframes determined on a case-by-case sitespecific basis rather than defining specific fixed 

period of performance

10
ACRS Letter Reports –

Key Issues

• Compliance with performance objectives after 

institutional control period should be evaluated 

considering FEPs for a given site for a period 

commensurate with the site-specific risk

• Protection of inadvertent intruder

– Large uncertainties associated with human intrusion 

scenarios will not help decision making

– Durability and stability should be sufficient

• Previously disposed wastes should not be 

subject to additional compliance evaluations

11
Rule status

• Proposed rule

– SRM-SECY-013-0075 issued February 12, 2014

– Published for comment on March 26, 2015 (80 FR 

16081) 

– 120 day comment; reopened August 27 –

September 21, 2015

• Draft final rule

– Submitted to Commission September 15, 2016

12
Public Comments on 

Proposed Rule

• Received 2,401 comment letters (2,300 form)

– Extensive public outreach

– Six workshops and webinar

• Represented:

– Individuals 

– Public interest groups

– Native American Tribal Governments

– Industry groups

– Licensees

– State and federal agencies

• Over 800 comments binned and responded to

13
Examples of 

Public Comments

• 3-Tier System

– More complicated than necessary

– 500 mrem dose goal reduces public health and safety

– RESPONSE: Changed to new, simplified approach

• Compatibility Category

– Reduced current health and safety provided by some 

States

– Most commenters recommended “C”

– RESPONSE: Changed compliance period definition 

and 61.58 to “C”

14
Examples of 

Public Comments (Cont)

• Grandfathering

– 61.1(a) should allow existing sites to grandfather

– Already disposed of wastes should not need to be 

addressed

– RESPONSE: Staff concluded that grandfathering not 

appropriate and removed confusing language in 61.1(a)

• Backfit

– Backfit analysis should be done because of impact on 

other licensees

– RESPONSE: No backfit in Part 61; NRC doesn’t address 

passed along costs

15
Draft Final Rule 

Major Changes

The rule 

• Requires a site specific analysis

• Provides a 1,000 or 10,000 year compliance period for 

protection of the general public

• Adds a new technical analysis for the protection of inadvertent 

intruders 

• Adds a new post-10,000-year performance period analysis 

• Adds a new requirement to update the technical analyses at 

site closure

• Adds a new requirement to identify DID protections

• Facilitates implementation and better aligns the requirements 

with current safety standards

16
Draft Final Rule Language –

Definitions (61.2)

• Compliance period 

– Site closure to 1,000 years if no significant quantities of 

long-lived radionuclides. 

– Site closure to 10,000 years otherwise

• Defense-in-depth

– Use of multiple independent and, where possible, 

redundant layers of defense such that no single layer, no 

matter how robust, is exclusively relied upon

– Includes, but is not limited to, the use of siting, waste 

forms and radionuclide content, engineered features, and 

natural geologic features of the disposal site to enhance 

the resiliency of the land disposal facility 

17
Draft Final Rule Language –

Definitions (61.2)

• Inadvertent intruder assessment is an analysis that:

– Assumes inadvertent intruder occupies site and 

engages in normal activities and other reasonably 

foreseeable pursuits that are realistic and consistent 

with expected activities in and around the disposal 

site at the time of the assessment

– Examines capabilities of intruder barriers to inhibit 

contact with the waste or limit exposure to radiation 

from the disposal unit

– Estimates inadvertent intruder’s potential annual dose 

considering uncertainties.

18
Draft Final Rule Language –

Definitions (61.2)

• Long-lived radionuclide means radionuclides: 

– Where more than 10 percent of the initial activity of the 

radionuclide remains after 1,000 years

– Where the peak activity from progeny occurs after 1,000 

years; or 

– Where more than 10 percent of the peak activity of the 

radionuclide (including progeny) within 1,000 years 

remains after 1,000 years

19
Draft Final Rule Language –

Definitions (61.2)

• Performance assessment 

– analysis to demonstrate compliance with the 

performance objectives

– identifies the features, events, and processes that 

could affect the disposal site performance

– estimates the potential dose as a result of releases 

caused by all significant features, events, and 

processes including the uncertainties

• Performance period 

– timeframe established to evaluate the performance of 

the disposal site after the compliance period

20
Draft Final Rule Language –

Definitions (61.2)

• Safety case 

– Collection of information that demonstrates the 

assessment of the safety of a land disposal facility

– Includes technical analyses, DID, and supporting 

evidence and reasoning 

– Also includes description of the safety relevant 

aspects of the disposal site, the design of the facility, 

and the managerial control measures and regulatory 

controls.

21
Draft Final Rule Language –

• 61.12 Specific Technical Information 

- New DID requirement added as 61.12(o) 

- Requires identification of DID protections, 

including a description of the capability of 

each DID protection relied upon to maintain 

safety and a basis for the capability of each 

DID protection

- Not an analysis

22
Draft Final Rule Language –

• 61.13 Technical Analyses

– Requires performance assessment for compliance period that:

• Considers features, events, and processes that represent a range of 

phenomena with both beneficial and adverse effects on performance

• Considers the likelihood of disruptive or other unlikely features, events, or 

processes

• Provides a technical basis for models used 

• Evaluates contaminant transport pathways and processes in environmental 

media (e.g., air, soil, groundwater, surface water) 

• Accounts for uncertainties and variability in the projected behavior of the 

disposal site and general environment and in the demographics and 

behaviors of human receptors

• Identifies and differentiates between the roles performed by the natural 

disposal site characteristics and design features in limiting releases of 

radioactivity to the general population

23
Draft Final Rule Language –

• 61.13 Technical Analyses (cont)

– Requires inadvertent intruder assessment for compliance period 

that

• Assumes inadvertent intruder occupies the disposal site and engages in 

normal activities and other reasonably foreseeable pursuits that are 

consistent with the activities and pursuits occurring in and around the site at 

the time of development of the inadvertent intruder assessment.

• Is updated prior to closure to reflect any significant changes to the activities 

and pursuits occurring in and around the site.

• Identifies barriers to inadvertent intrusion that inhibit contact with the waste 

or limit exposure and provides a basis for the time period over which 

barriers are effective.

• Accounts for uncertainties and variability in the projected behavior of the 

disposal site and general environment.

24
Draft Final Rule Language –

• 61.13 Technical Analyses (cont)

– Analyses of the protection of individuals during operations 

• Includes assessments of expected exposures due to routine operations and likely accidents 

• Must provide reasonable assurance that exposures will be controlled to meet the 

requirements of 10 CFR Part 20

– Long-term stability analysis

• Evaluates need for ongoing active maintenance after site closure 

• Based on analysis of active natural processes, infiltration, and surface drainage of the 

disposal site. 

• Provides reasonable assurance that long-term stability of the disposal site can be ensured 

for the compliance period and that there will not be a need for ongoing active maintenance

– Performance period analysis

• Only required if 10,000-year compliance period used 

• Assess how disposal site limits the potential long-term radiological impacts during the 

performance period, consistent with available data and current scientific understanding. 

• Must identify and describe features of the design and site characteristics relied on

25
Draft Final Rule Language –

• 61.41 Protection of the general population from 

releases of radioactivity 

– Compliance period

• Limits annual dose to 0.25 milliSieverts (25 millirems) to any 

member of the public

• Demonstrated through analyses that meet the requirements 

specified in § 61.13(a).

– Performance period

• Must minimize releases of radioactivity to the general environment 

to the extent reasonably achievable

• Demonstrated through analyses that meet the requirements 

specified in § 61.13(e).

26
Draft Final Rule Language –

• 61.42 Protection of individuals from inadvertent 

intrusion.

– Compliance period

• Limits annual dose to 5 milliSieverts (500 millirems) to any 

inadvertent intruder

• Demonstrated through analyses that meet the requirements 

specified in § 61.13(b).

– Performance period

• Must minimize exposures to any inadvertent intruder to the extent 

reasonably achievable 

• Demonstrated through analyses that meet the requirements 

specified in § 61.13(e).

27
Draft Final Rule Language –

• 61.58 Alternative requirements for waste 

classification and characteristics.

– Specifies waste acceptance criteria

– Requires waste certification

– Requires annual review of content and implementation 

of the waste acceptance criteria, waste characterization 

methods, and certification program

28
QUESTIONS?

?????

29
Path Forward

• Commission review

• If approved for publication

– Incorporate Commission directed changes

– Send to OMB for review (~90 days)

– Send to Federal Register for publication

• Effective date: 1 year from publication

• License updates due next renewal or within 5 

years of effective date

• Agreement States have 3 years from publication 

to implement compatible regulations

30
BACKUP SLIDE

31
Timeframe changes

32
Overview of Major Technical Elements of 

10 CFR Part 61

David Esh, PhD

Senior Risk Analyst

United States Nuclear Regulatory Commission

Presented to the ACRS Radiation Protection and Nuclear Materials 

Subcommittee, October 18, 2016
Outline

• Safety Case

• Defense-in-Depth

• Analysis Timeframes (Significant Quantities)

• Technical Analyses

– Performance Assessment

– Intruder Assessment

– Site Stability

• Waste Acceptance Requirements

• Guidance (NUREG-2175)

2
Safety Case

• A collection of arguments and evidence to demonstrate the safety of a 

land disposal facility (e.g. defense-in-depth protections and technical 

analyses).

• Describes all safety relevant aspects of the disposal site, the design of the facility, and the managerial control measures and regulatory controls 

to inform the decision whether to grant a license.

• Includes the same type of information that the original 10 CFR part 61 

required to be submitted as part of a license application (i.e., 10 CFR 61.10 – 10 CFR 61.16).

• The safety case will be updated over time as new information is gained 

during the various phases of the facility’s development and operation. 

3
Safety Case

• Plain language description of:

– Strategy for achieving safe disposal

– Safety arguments that highlight the main evidence that 

quantify and support the claim that the land disposal 

facility will be safe

– The disposal site and facility

– Information about the nature of the waste and the design 

and proposed operation of the facility

– The technical analyses that demonstrate performance 

objectives

– Strategy for institutional control of the disposal site

– Licensee’s financial qualifications

4
Defense-in-Depth

• The use of multiple, independent, and, where 

possible, redundant layers of defense so that no 

single layer, no matter how robust, is exclusively 

relied upon.

5

Note: Lifecycle timeframes not to scale

IMPLICIT

EXPLICIT
Defense-in-Depth Requirements

• Identify defense-in-depth protections commensurate 

with risks.

• Describe capabilities of defense-in-depth protections.

• Provide a technical basis for capabilities of defense-indepth protections.

6
Defense-in-Depth for LLW Disposal

• Operations

– Provide for active and passive safety systems commensurate with 

the hazard and complexity of the activities.

• Post-Closure

– Disposal site is essentially a passive system, relying on both natural 

site characteristics and engineered features.

– Diversity of capabilities of the components and attributes of the 

disposal site increases the site’s resilience to unanticipated failures 

or external challenges. 

– Each layer of defense must make a definite contribution to the 

isolation of the waste.

– Capabilities of site characteristics and engineered features over 

long timeframes are subject to interpretation and many 

uncertainties. These uncertainties can be quantified generally and 

are addressed by requiring the use of multiple layers of defense. 

7
Timeframes

8

Waste specific
Timeframes

9

• Throughout the process, significant interest in the analyses 

timeframes.

• Significant comments received reflecting diverse opinions.

• Staff devoted significant effort to the formulation of the final 

position.

• Key features:

– Compliance period is 1,000 years or 10,000 years depending on if 

the site will contain significant quantities of long-lived radionuclides.

– Performance period only applies if the compliance period is 10,000 

years.

– Compatibility criteria is C (Agreement State may be more 

restrictive).
Significant Quantities

10

How does one determine if they have significant 

quantities? 

– Start simple and if necessary introduce more complexity

1. Perform screening based on inventory

2. Perform screening based on simplified dose 

assessment

3. Site-specific analysis (case-by-case)
Significant Quantities - Example

11

Example A licensee wishes to dispose of waste at a disposal site that does not have a 

potable groundwater pathway or any credible mechanisms for release other than from 

disturbance by inadvertent intruders. The total volume of disposal cells for existing waste is 

400,000 m3. The inventory of waste located in the facility is comprised of: 50,000 m3 of C-14 

containing waste at 0.2 Ci/m3, 200,000 m3 of waste containing C-14 at 0.1 Ci/m3 and I-129 at 

0.002 Ci/m3, and 50,000 m3 of Tc-99 containing waste at 0.01 Ci/m3. The uncontaminated fill 

and material used to construct the cells represents 100,000 m3.

Conclusion: The licensee uses the Class A waste concentrations to calculate the volumeaveraged SOF per the following equation. This equation is used to calculate the SOF for n

waste streams containing m isotopes. V is the volume, C is the concentration on a volumetric 

basis, and CA is the Class A waste limit for the particular isotope.

Because the SOF is less than 1, a 1,000-year compliance period can be used and 

performance period analyses are not required.
Performance Assessment

12

Performance assessment is an analysis used to 

demonstrate compliance with 10 CFR 61.41(a) and (b) that 

identifies the features, events, and processes that could 

affect the disposal site performance; and estimates the 

potential dose as a result of releases caused by all significant 

features, events, and processes including the uncertainties.
Performance Assessment

13

• Performance assessment is not a new topic – renaming 

of technical analyses

• New requirements in 61.13:

 Scope (features, events, and processes)

 Uncertainty and variability

 Model support

• Requirement to update the performance assessment at 

closure

• Modified siting characteristics consistent with disposal 

of long-lived waste

IMPLICIT

EXPLICIT
Performance Assessment

14

61.50: Informed 

by timeframes

61.28: Update PA 

at closure

61.58: PA results may be 

used to develop WAC

61.13: Features, 

events, and processes

61.13: Uncertainty 

and variability

61.13: PA results 

considered in DID 

and safety case

61.13: Model support
Performance Assessment

15
Inadvertent Intrusion Assessment

• Similar to performance 

assessment, except:

– Receptor scenarios

– Onsite exposures

– 500 mrem/yr limit

– Precluded during 

institutional control 

period (i.e., 100 yrs)

16
Inadvertent Intruder Receptor

• Normal Activities

– Dwelling Construction

– Agriculture

– Drilling for Water

• Reasonably Foreseeable 

Activities

– Consistent with activities 

in vicinity of site when 

assessment developed

17
Normal Activities

18

Dwelling Construction

Agriculture

Drilling for Water
Site-specific Scenarios

• Constrain exposure pathways for normal or 

reasonably foreseeable activities based on:

– Physical information

• Waste characteristics and disposal practices

• Disposal site characteristics

– Cultural information (e.g. land use)

19
Site Stability

20

• Consideration of site stability is an important part 

of the safety strategy.

• Site stability is required for the compliance 

period but may be performance-based.

• Guidance describes design-based and modelbased approaches.
Site Stability

21
Site Stability

Temporal, Spatial scales = f(Waste)

22
Waste Acceptance Requirements

• Licensees must review 

their waste acceptance 

program at least annually

• Ensures that the program 

continues to be adequate 

and is being implemented 

in a way that continues to 

protect public health and 

safety

23
Waste Acceptance Criteria

• Allowable Limits on Radioactivity

• Wasteform Characteristics and 

Container Specifications

• Restrictions and Prohibitions

24
Waste Acceptance

• Flexibility to develop site-specific waste 

acceptance criteria.

• Use 61.55 limits, results of technical analyses, or 

combination of both to develop criteria.

• Either way, licensees must demonstrate that 

criteria will demonstrate that performance 

objectives will be met.

25
Allowable Limits from §61.55

26

Yes

No

Conduct

technical analyses

to determine if additional limits 

are needed to meet 

performance objectives.

Waste is not required to 

be segregated per 

10 CFR 61.52(a)(1).

Demonstrate 

compliance w ith 

minimum requirements 

specified at 

10 CFR 61.56(a).

Demonstrate 

compliance w ith 

stability requirements 

specified at 

10 CFR 61.56(b).

Does w aste 

meet stability 

requirements at 

10 CFR

61.56(b)?

Class A w aste is 

required to be 

segregated per 10 

CFR 61.52(a)(1).

Demonstrate compliance 

w ith intruder barrier 

requirement specified at 

10 CFR 61.52(a)(2).

Determine w aste class per

10 CFR 61.55.

Determine concentrations of 

radionuclides in w aste.

Class A Class B Class C Greater

Than

Class C

Generally not 

acceptable for 

near-surface 

disposal per 

10 CFR 61.55.

Evaluate on a 

case-by-case 

basis.
Allowable Limits from Analyses

27
Waste Characterization

• Licensees must specify acceptable methods for 

characterizing waste

– Acceptable methods to characterize waste

– Criteria for determining an acceptable level of uncertainty in 

the characterization data

– Documentation required to ensure sufficient detail is available 

to demonstrate that the waste acceptance criteria are met 

• Ensure that knowledge of the waste’s characteristics is:

– Commensurate with the assumptions and approaches used to 

develop the waste acceptance criteria

– Sufficient to demonstrate that the waste acceptance criteria 

are met

28
Characterization Methods

• Direct or indirect (materials accountability, 

characterization by source, scaling factors) 

methods

• Data quality

• Documentation

– Responsibilities

– QA

– Procedures

– Records

29
Waste Certification

• Program to certify that waste meets the acceptance 

criteria prior to receipt at a disposal facility

– Designate the authority to certify and receive waste for 

disposal at the disposal facility

– Provide procedures for certifying that waste meets the 

waste acceptance criteria

– Specify documentation required for waste characterization, 

shipping and certification

– Identify records, reports, tests, and inspections that are 

necessary to maintain and provide criteria for auditing

– Provide approaches for managing certified waste to 

maintain its certification status

30
NUREG-2175

• NUREG-2175 (Guidance for Conducting Technical 

Analyses for 10 CFR Part 61) provides:

─ Flowcharts, NRC staff recommendations, and 

examples for how licensees can develop high-quality 

technical analyses

─ Guidelines for what licensees or applicants should 

include and what regulators should review for each 

type of analysis

─ Suggested references, screening tools, and case 

studies

31
NUREG-2175

• Draft NUREG-2175 (Guidance for Conducting Technical Analyses 

for 10 CFR Part 61) 

– Issued at same time as Proposed Rule (March 26, 2015)

– Discussed in seven public meetings including in a dedicated 

webinar (May 2015)

– Same extended public comment period as proposed rule

– Received seven sets of comment letters 

• Individuals, public interest groups, industry, licensees, and 

federal agencies

• Final guidance document has been developed (in concurrence) 

− Will be issued after Commission approves Final Rule publication

32
Major Comments Received

• Analyses timeframes

– Protective Assurance Period and three-tiers is 

confusing and should be eliminated

• Defense-in-Depth

– Requirement for a separate “analysis” should be 

clarified

• Confusion on various timeframes discussed

• Questions on site closure process

• Clarification on inadvertent intruder assessment 

scenarios

33
Major Revisions Made

34

• Analyses timeframe

– Eliminated protective assurance period

– Modified compliance period discussion

– Added detail and examples on how to determine if a site has 

significant quantities of LLW

• Defense-in-Depth

– Clarified the requirement to identify defense-in-depth 

protections and describe their capabilities

• Added figures describing site closure process, timeframes for 

evaluation, process for developing allowable limits 

• Appendix with responses to public comments received

• Added appendix on 10 CFR Part 61 DEIS default scenarios
Put Title Here

Put SubTitle Here

Presentation to the NRC ACRS RP & NM Subcommittee

The CRESP Management Board

Craig Benson8, Joanna Burger2, James Clarke1, Michael Greenberg2, Kathryn Higley3, 

Kimberly Jones4, David Kosson1, Steve Krahn1, Shlomo Neuman7, Ron Rousseau9, Richard Stewart5

1Vanderbilt University, 2Rutgers, The State University of New Jersey, 3Oregon State University, 4Howard University, 5New York 

University, 6Robert Wood Johnson Medical School, 7University of Arizona, 8University of Wisconsin- Madison, 9Georgia 

Institute of Technology

CRESP Comments on Proposed Rule 10CFR61

October 18, 2016 1
CRESP Mission

Support safe, effective, publicly-credible, risk-informed 

management of existing and future nuclear waste from 

government and civilian sources through independent 

strategic analysis, review, applied research and 

education.

www.CRESP.org

2
• CRESP operates under a Department of Energy cooperative 

agreement awarded to Vanderbilt University. The multiuniversity consortium is working to advance cost-effective, riskinformed cleanup of the nation's nuclear weapons production 

facility sites and cost effective, risk-informed management of 

potential future nuclear sites and wastes. 

• Members of the CRESP Management Board commented on the 

2013 and 2015 drafts for 10CFR61 LICENSING REQUIREMENTS 

FOR LAND DISPOSAL OF RADIOACTIVE WASTE

www.CRESP.org

3
• We applaud and strongly support the Nuclear 

Regulatory Commission’s Risk-Informed, 

Performance-Based Approach.

• If we took issue with certain aspects of the 

proposed regulations, it was because we 

believed that the approach was departing 

from a Risk-Informed, Performance-Based 

Approach.

www.CRESP.org

4
• Several provisions in the draft proposed rules of 2013 and 

2015 “commendably reflect and implement a riskinformed, performance-based approach”.

• Notably they include provisions for site specific waste 

acceptance criteria, site specific performance assessment, 

and the use of updated dosimetry. (2013 comments).

• Furthermore, we noted that site specific assessments of 

exposure to an inadvertent intruder, and provisions for 

defense-in-depth and safety case evaluations were 

positive additions, consistent with risk-informed, 

performance-based regulation (2015 comments)

www.CRESP.org

5
However, we expressed concerns that there 

were parts of the proposed regulations where 

the NRC was still not taking a risk-informed 

performance-based approach, in particular, the 

continued incorporation of very long time 

frames that greatly exceed our experience and 

forecasting abilities. 

www.CRESP.org

6
Comments from Jim Clarke Consultant to the ACRS

7

• It appears that the staff concerns reflected in 

the Proposed Rule stem from the appearance of 

quantities of long-lived radionuclides from 

activities that were unanticipated when10CFR61 

was first promulgated.

• These are understandable and legitimate 

concerns.

• However, they should be addressed through the 

regulations in a way that is consistent with NRC’s 

risk-informed, performance-based approach.
8

Comments from Jim Clarke, Consultant to the ACRS

• The draft regulations were revised to eliminate the “protective 

assurance period” from 1000 to 10,000 years, however, the 

revision now states that the compliance period would be either 

1000 or 10,000 years depending on the inventory and 

concentration of long-lived radionuclides intended for disposal.

• However, a compliance period of 10,000 years is neither riskinformed nor performance-based. This time period is outside our 

current body of knowledge and greatly exceeds our ability to 

forecast the future.

• My personal feeling is that our current ability to forecast future 

events would be better limited to a few hundred years, but I 

appreciate that 1000 years has some standing e.g., with the 

Department of Energy.
Comments from Jim Clarke Consultant to the ACRS

9

• With respect to the intruder assessment, I 

appreciate that the staff was directed, by the 

Commission, to use a 10,000 year period, but 

have the same concerns about the merits of 

putting unrealistically long time frames in 

regulations.

• Rather the intruder assessment, as the draft 

regulations support, should be approached on a 

site-specific and waste-specific basis.
Comments from Jim Clarke Consultant to the ACRS

10

• In summary, I appreciate that the appearances of larger 

amounts of long-lived radionuclides requiring disposal 

and waste streams that did not exist at the time, were 

unanticipated, when 10CFR61 was first promulgated 

almost 35 years ago.

• However, these unanticipated events appear to be 

driving the proposed regulations to positions that are 

neither risk-informed nor performance-based viz. the 

imposition of a 10,000 year compliance period in 

certain cases and a 10,000 year intruder assessment.
Comments from Jim Clarke Consultant to the ACRS

11

• Perhaps these unanticipated waste streams, such 

as DU, can be handled in other ways, possibly 

through guidance, that do not require the 

imposition of an unrealistic compliance period, 

rather that letting their occurrence drive the 

regulations. 
In closing my experience with the NRC covers over 16 years:

• Consultant to the Nuclear Regulatory Commission, Advisory Committee on 

Nuclear Waste. 2000-2004

• Member, Nuclear Regulatory Commission Advisory Committee on Nuclear 

Waste and Materials 2005 -2008

• Consultant to the Nuclear Regulatory Commission Advisory Committee on 

Reactor Safeguards, 2008 to present

The people from the NRC with whom I have had the pleasure to work are 

extraordinary.

Indeed, I hold the NRC and its staff in very high regard.

We just apparently disagree over the merits of including extremely long 

time periods as “compliance periods” in enforceable regulations.

Comments from Jim Clarke Consultant to the ACRS
Comments from Jim Clarke Consultant to the ACRS

13

• I appreciate the opportunity to provide these 

comments on behalf of CRESP and me and would 

be pleased to address any questions you might 

have.
Questions?

14