ML20044H064

Transcript of 930526 Meeting in Rockville,Md Re Briefing on Status of Efforts for Risk Harmonization.Pp 1-77.Supporting Documentation Encl

ML20044H064
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Issue date:	05/26/1993
From:	NRC COMMISSION (OCM)
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REF-10CFR9.7 NUDOCS 9306070333
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RISK HARMONIZATION '~ . j t 'i f Location:- ROCKVILLE, MARYLAND f b3I6* MAY 26, 1993 PagGS 77 PAGES 4 NEALR.GROSSANDC0.,INC. COURT-REPORTERS AND TRANSCRIBERS 1323 Rhode. Island Avenue, Northwest Washington, D.C. 20005 (202) 234-4433 i 5

1 DISCLAIMER This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on May 26, 1993, in the Commission's office at One White Flint North, Rockville, Maryland. The meeting was l open to public attendance and observation. This transcript i i t has not been reviewed, corrected or edited, and it may contain inaccuracies. l I The transcript is intended solely for general I informational purposes. As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with I the Commission in any proceeding:as the result of, or i addressed to, any statement or argument contained herein, except as the Commission may authorite. 9 NEAL R. GROS $ court Rf>0RTER$ AND TRAN$CRfttt$ 1313 RHODI ISLAMB AYtHut H.W. (202) 234-4433 WA$HINGToH DL 2000$ ' (202) 232-6600 i I _______m_

1 1 UNITED STATES OF AMERICA l NUCLEAR REGULATORY COMMISSION BRIEFING ON STATUS OF EFFORTS FOR RISK HARMONIZATION PUBLIC MEETING Nuclear Regulatory Commission One White Flint North Rockville, Maryland 4 Wednesday, May 26, 1993 1 The Commission met in open

session, pursuant to notice, at 2:00 p.m., Kenneth C.

Rogers, Commissioner, presiding.

COMMISSIONERS PRESENT: KENNETH C. ROGERS, Commissioner JAMES R. CURTISS, Commissioner l FORREST J. REMICK, Commissioner E. GAIL de PLANQUE, Commissioner NEAL R. GROSS 1 COURT REPORTERS AND TRANSCRIBERS i 1323 RHODE ISLAND AVENUE, N W. (202) 234 4 33 WASHINGTON, D C. 20005 (202) 234-4433

2 STAFF SEATED AT THE COMMISSION TABLE: JOHN C. HOYLE, Assistant Secretary MARTIN MALSCH, Deputy General Counsel for_ Licensing i and Regulations j JAMES TAYLOR, Executive Director for Operations l i ROBERT BERNERO, Director, NMSS .l RICHARD BANGART, Director, Division of LLW Management and Decommissioning, NMSS i JOHN AUSTIN, Chief, Decommissioning and Regulatory i Issues Branch, NMSS f MICHAEL WEBER, Section Leader, Regulatory Issues j Section, NMSS l } t 6 t o 3 i f NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS f 1323 RHODE ISLAND AVENUE, N W. (202) 2344 433 WASHINGTON. D C. 20005 - (202) 2344433 l

3- [ 1 P-R-O-C-E-E-D-I-N-G-S ( 2 2:00 p.m. 3 COMMISSIONER ROGERS: Good afternoon, 4 ladies and gentlemen. i 5 The Commission is meeting at this time to 6 receive a briefing from the NRC staff on the status of 7 efforts for risk harmonization. The staff has already 8 provided the Commission with an information paper on 9 this matter and copies should be available here in the 10 conference room. t 11 Before we begin our discussion of this 12 important topic, Chairman Selin has asked me to 13 express his regret that he's unable to attend today's f 14 meeting due to other government business. 15 By way of introduction, let me recount 16 just the most essential details of our dialogue with 17 EPA on risk harmonization.. In March of 1992, we were. 18 able to successfully conclude an effort to put in 19 place a memorandum of understanding with EPA to help 1 20 resolve issues of concern to both agencies. The March t 21 1992 MOU represents a major step forward to foster 22 cooperation between the Nuclear-Regulatory Commission 23 and the Environmental Protection Agency.in carrying 24 out agency mandates to protect the public health and ^ 25 safety and the environment on matters related to. i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVENUE, N W, (202) 2344 433 WASHINGTON, D.C 20005 (202) 2344433

i ? 4 1 radiation in the environment. 2 The MOU is essential for constructive 3 interactions between the agencies' because it 4 establishes a framework for: first, resolving issues [ 5 of mutual agency concern; second, avoiding unnecessary i 6 duplication of regulation; and

finally, focusing

-{ 7 priorities on the most significant safety and 8 environmental problems. t 9 The MOU also includes an important j l 10 provision, Section D, calling for NRC and EPA to 11 actively explore ways to harmonize health-risk goals 12 and to cooperate in developing a mutually agreeable [ 13 approach to health risk assessment methodologies for 1 14 radionuclides. Risk harmonization is a critical { 15 activity under the MOU because differing risk l 16 management approaches have been a root cause in areas 17 of disagreement between the two agencies. NRC and EPA t 18 are actively pursuing health risk harmonization both i 19 in a generic manner and through ongoing cooperative f 20 activities to resolve specific issues in program 21 areas. i 22 The most basic prerequisite for the 'l 23 cooperative efforts contemplated under the MOU is 24 prior agreement between the agencies on acceptable i 25 risk limits or in reality a common answer to the l ~ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON, D.C. 20005 (202) 2344433

5 1 question how safe is safe enough. It is with this in 2 mind that the MOU calls for the agencies to actively 3 explore ways to harmonize risk. goals. 4 Since this question is of such importance 5 to making the MOU work, the Commission is keenly I 6 interested in the staff's efforts in this area and 7 anxious to hear what the staff has to say today. l 8 Do my fellow Commissioners have anything 9 before we begin? t 10 Mr. Taylor, please begin. i 11 MR. TAYLOR: Good afternoon. With me at 12 the table are Bob Bernero, Mike Weber, Dick Bangart 13 and John Austin, all from NMSS. 14 As you know noted, Commissioner Rogers, i 15 this is a status update of where we are on the subject 16 of risk harmonization. i 17 To kick it off, Mike Weber will be the 18 principal presenter. 19 MR. WEBER: Thank you. i 20 Good afternoon. We certainly appreciate 21 the Commission's interest in this topic and also the l 22 briefing this afternoon. 23 It is interesting to note that EPA also 24 holds risk assessment in high regards and risk 25 management. Recently the issue of the EPA Journal NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON. D C 20005 (202) 734-4433

^

t 6 -.

I I featured a whole issue on risk assessment'and there's 2 a lot of useful insights in there from a variety of ] 3 different perspectives. J \\ 4 (Slide) Commissioner Rogers, if I could 5 have the first slide, please. 6 As you pointed out, the focus of this 7 effort is derived from the Memorandum of Understanding I 8 that the EPA Administrator and the Chairman signed 9 back in March of last year. That MOU provides the 10 basic framework for cooperative activities between the i 11 agencies on a wide variety of subjects, in addition to-12 laying out the goal and principles that would guide 13 those cooperative activities. . It also provides. f f 14 implementation guidance and it is in the 15 implementation guidance, Section C, that the staffs of 16 both agencies are directed to actively explore 'I 17 harmonization activities, both in terms of risk goals, 18 in other words risk management activities, as well.as -i 19 mutually agreeable approaches for risk assessment. [ 20 We'll be getting into some of those terms as we 21 proceed through the briefing. 22 (Slide) If I could have the next slide, 23 please. I 24 Shortly after the MOU was signed, the 25 staffs met to discuss the implementation of the MOU. ~ NEAL R. GROSS i COURT REPORTERS AND TRANSCllBERS 1323 RHODE ISLAND AVENUE N W. (PC2) 2344433 WASHINGTON, D C. 20005 (202) 2344433

7 1 That meeting identified five priority issues for 2 pursuit under the framework established by the MOU. 3 Clean Air Act regulation of radionuclides, the 4 Subparts I, T and W of EPA's regulations in 40 CFR 61, 5 EPA's draft Low Level Radioactive Waste Standards, 6 groundwater protection standards for uranium mill 7

tailings, principally agreement on-guidance and l

8 criteria for approving alternate concentration limits 9 for contaminants in groundwater at the uranium' mill 10

sites, radiological criteria for decommissioning.

11 This principally involves our enhanced participatory l 12 rulemaking on the radiological criteria as well as 13 EPA's parallel efforts to-establish generally-14 applicable standards. And then EPA's high-level waste 15 standards, what we commonly refer to as the Yucca and 16 the Non-Yucca standards, which are being pursued. 17 One common theme of all these issues is 18 the need for an effort on risk harmonization because, 19 Commissioner Rogers, as you pointed out, it has been t 20 identified as a root cause of the differences between 21 the agencies. 22 In each program area there exists both 23 real and perceived differences in both the risk goals 9 24 and assessments. These need to be addressed head on 25 and it's through the cooperative efforts both on a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON D C. 20005 (202) 234-4433

r 8 1 generic level through the generic activities on risk 2 harmonization as well as the individual program areas 3 that the staffs have been pursuing those. The status 4 of those activities is described in the SECY paper i 5 which is available at the entrance to the Commission 6 meeting room. 7 COMMISSIONER ROGERS: Just before you move 8 on, Mike. 9 MR. WEBER: Yes. 10 COMMISSIONER ROGERS: I think you said it, 11 but I thought I'd just check again. These five i 12 priority issues were mutually agreed upon between NRC j 13 and EPA at that first meeting. Is that what you --- 14 MR. BERNERO: Yes. That first meeting, I 15 Mike Shapiro, the Deputy Assistant Administrator for f 16 Air and Radiation, and I, with our staff, went over f 17 all of the issues. These represent a combined - t 18 priority, EPA's and NRC's. 19 COMMISSIO!!ER ROGERS: Okay. Thank you. j 20 MR. WEBER: (Slide) If I could have the ~ 21 next slide, please. 22 There are various components to our t 23 efforts on risk harmonization. Consistent with the 'l 24 Memorandum of Understanding, the staff differentiated 25 early in its efforts the difference between risk l ^ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS g 1323 RHODE ISLAND AVENUE. N W. l (202) 2344433 WASHINGTON. D C,20005 (202) 234-4433-

9 1 assessment and risk management. Risk assessment 2 principally attempts to answer-the question-how risky 3 is something. It includes the consideration of the i ~ 4 methods, the assumptions that are made and other 5 considerations involved in quantifying'or estimating l 6 health risks. This would also include to a certain 7 extent the uncertainties associated with those risk i i 8 estimates. D 9 Risk management, in contrast, would answer 10 the question what should be done about something that 11 poses a risk, which is especially important to a i 12 regulatory agency, both NRC and EPA. It involves the i 13 selection of risk goals and associated measures in 14 attempting to achieve those goals. It also involves i 15 things like value judgments, considerations of 16 uncertainty and how that should play into the 17 regulatory decisions, technological feasibility in 18 demonstrating compliance or in meeting the regulatory 19 requirements, as we]l as cost effectiveness and other 20 considerations. 21 I should point out at this point that by 22 risk we're principally referring to health risk 23 assessment and management. That's to distinguish it 24 from engineering risk assessment. You may be familiar f 25 with the National Academy of Science's report, the i NEAL R. GROSS OOURT REPORTERS AND TRANSCRIBERS j 13.'3 RHODE ISLAND AVENUE. N W j (202) 234 4433 WASHINGTON, D C. 20005 (202) 2344433

I 10 1 -1983 report called the red book, informally, on risk l 2 assessment. Based on those earlier discussions in the 3_

1980s, a distinction was drawn by a variety of 4

agencies, including NRC and EPA, on the difference ~ 5 between risk management and risk assessment, and also 6 the difference between health risk assessment which j 7 would involve basically assuming that exposure will l l 8 occur and then trying to estimate the risk associated 9 with the exposure versus engineering risk assessment 10 which involves consideration of failure of engineered 11 barriers or natural systems which eventually might [ 1 12 lead to human exposure. So, that's an important 13 distinction. l 14 In the environmental protection area, 15 human health risk assessment and management is the i i 't 16 principal focus. That's not to exclude engineering 17 risk assessment, but generally EPA has not delved into

-t 18 that arena, whereas our agency certainly gets involved

-j i i 19 in those things on things like severe accidents and j 20 similar matters. 21 I should also point out that the agencies i 1 22 first focused on risk assessment. In other words, as l 23 we pursued the generic efforts on risk harmonization, l t 24 we felt it was important first to look at risk - 1 i 25 assessment for two reasons. One, because it appeared l NEAL R. GROSS i COURT REPORTERS AND ThANSCRIBERS 6 1323 RHODE ISLAND AVENUE N W. i (202)2344433 WASHINGTON. D C. 20005 (202) 234 4433

i 11 I simpler at the

outset, delving only into the 2

scientific aspects, how does one estimate the risk 3 associated with an exposure, and also it seemed to be i 4 a necessary prerequisite to the discussions which 5 would follow on risk management. If we were going to 6 look at the levels that were being achieved in the 7 various regulatory programs, it was important that we 8 speak with a common denominator and to achieve that 9 common denominator in terms of an estimated risk, we 10 first needed to address risk assessment. 11 (Slide) If I could have the next slide, 12 please. 13 COMMISSIONER REMICK: Mike, how difficult 14 is risk assessment since I believe, at least I assume, 15 that we and EPA pretty.well follow ICRP and NCRP in 16 many ways in determining health consequences? 17 MR. BERNERO: I'd like to interject if I 18 could, Mike, here. 19 MR. WEBER: Sure. [ i 20 MR. BERNERO: Basically in radiation, I 21 think it's fair to say that the Environmental 22 Protection Agency has a tendency to track and 23 participate in ICRP, NCRP activity, but they act 24 independently and they aren't always coincident in the 25 identification of risk coefficients or any other 3 i NEAL R. GROSS ) COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. 4 (202) 2344433 WASHINGTON. D.C. 20005 (202) 2344 433

12 1 measures of ways to link radiation exposure to health j i 2 consequences. They're close -- l 3 COMMISSIONER REMICK: But you could say 4 that about us too. 5 MR. BERNERO: Yes. Yes. But they're 6 close, but fairly consistent. The biggest problem is f 7 that the Environmental Protection Agency has other 7 8 actions deriving from non-radiological risk. 9 COMMISSIONER REMICK: No, I'm talking i 10 about radiological risk. 11 MR. BERNERO: Yes. Okay. l 12 COMMISSIONER REMICK: Yes. I'm. talking 13 about the two agencies. I'm not surprised. We come i 14 pretty close together in risk assessment techniques 15 since we rely at least to some extent -- 16 MR. BERNERO: For. radiological risk { 17 assessment, that is a fair comparison. r 18 COMMISSIONER REMICK: Yes. Okay. t 19 MR. BERNERO: But it's when you get into i 20 risk management that you're going to get a different-- 21 COMMISSIONER REMICK: Right. 22 COMMISSIONER ROGERS:

Well, I take it 23 though from the SECY paper that there are considerable

+ 24 differences, for example in modeiing methods. Several t ~ 25 examples were given there, in particular carbon-14 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON, D C. 20005 (202) 234 4433 l

13 1 problem and how that seemed to arise from a difference i 2 in how.one might model situations and with a simpler 3 model one feels more comfortable setting higher-4 requirements than with a model which perhaps may be 5 more realistic and therefore you might find you could I 6 not achieve those requirements. I think that's i 7 precisely the case with carbon-14, isn't it? So, i 8 that's in the assessment area. That's not in the 9 management area. 10 COMMISSIONER REMICK: No, but it's i 11 engineering, as I see it. I see that as part of 12 engineering risk. You're modeling the release. 13 MR. BERNERO: Again, take the carbon-14 14 and high-level waste, which is a very difficult 15 subject. I think if you speak of radiological 16 exposure and consequences,.given the presence of a 17 certain amount of carbon-14, its half-life and so 18 forth, and given that one is calculating a collective 5 19 dose, we would agree with the assessment that EPA has. 20

Now, there is an element of engineering risk i

21 assessment here, how does the carbon-14 come out of 22 spent fuel right away or slowly or whatever and how i 23 does it get through the package? But those 24 considerations aren't-really the dominant 25 consideration and the dominant controversy. The NEAL R. GROSS COURT REPORTERS AND TRANSCPiBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON, D C. 20005 (202) 2344433 ) I

1 14 1 1 dominant controversy is risk management. Given that 2 you calculate a-collective dose over that-many 3 generations from carbon-14, is it significant? It is 4 an amount of carbon-14 that meets the Clean Air Act 5 for an operating facility, but from the perspective of 6 a collective dose over 10,000 years, a risk-management 7 consideration, that's where we have the problem. 8 So, radiologically we agree on. what 9 carbon-14 is and how it. exposes the body, but the 10 management thereof is where we find difficulty. 11 MR. WEBER: I think it -- oh, excuse me. [ 12 COMMISSIONER de PLANQUE: Go ahead. 13 MR. WEBER: As we proceed, we're going to 14 get into some of these differences that.we did + 15 identify and it's a fair question. 16 .As we've addressed risk assessment, we 17 have included those analyses that are done to estimate 18 human exposure to the contaminant, whatever that 19 contaminant may be. So, if it involves transport of 20 a contaminant in the groundwater or in the atmosphere, t 21 that would fall under the risk assessment area. If l 22 the release of that contaminant was triggered by the 23 failure of a valve or something like that, that would 24 be more an engineering risk analysis. 25 COMMISSIONER REMICK: The difference being NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON. D.C. 20005 (202) 234 4433

15 1 in the health area we're just talking about the 2 consequence side, health consequences and not the 3 probability event that causes it. So, we're looking J i 4 as we used to do in the reactor area too. Look at i 5 consequences, :not the probability of the occurrence. 6 COMMISSIONER de PLANQUE: Let me go back 7 to what Commissioner Remick initially asked because I 8 saw something on page 4 of the paper which I couldn't 9 reconcile. If you're going to get to this later on, 10 you don't have to answer it now, but what I couldn't l-l 1 11 reconcile, which is what I think he was after, on the 12 top you have a group of bullets that say to discuss 13 the similarities. One of those, the third bullet, is 14 both agencies translate exposure and intakes 'into dose 15-and risk using internationally acceptable standards. 16 But then in your bullets on the differences, the third 17-and fourth ones, especie.11y the fourth one, you say j 18 NRC and EPA use slightly different risk coefficients 19 to convert doses and health effects. I was having 20 trouble reconciling those two and I think that's 21 probably where you were confused too. 22 So, I'm not sure which is the overriding 23 consideration there or if they're somewhat 24 inconsistent. i ~ 25 - MR. WESER : We'll get into that as we talk 1 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 W ASHINGTON, D.C. 20005 (202)2344433

16 1 about the differences and the similarities. 2 (Slide) If I could have the next slide, 3 please. 4 I think this graphic depicts where the 5 agencies currently are in terms of risk harmonization. i 6 We have a risk barometer, a thermometer down the 7 middle of the page. Those are-lifetime risk' 4 8 estimates, a cancer that could be attributed to the 9 exposure to_ contaminant, ranging from 10-2 or_one in 10 100 at the upper end of the scale, to 10 to a one in i 11 a million'at the lower end of the scale. 12 The NRC's traditional approach consistent 13 with international and national recommendations and 14 health physics practices has primarily been driven by-15 a top down approach whereby the NRC-establishes an 16 adequate protection threshold and.then applies various 17 mechanisms like ALARA or the concept that doses should j 18 be kept as Icw as reasonably achievable to drive those 19 doses or the risks associated with the exposures down f 20 well below that safety limit. That, based on the 21 information that we have, has been effective in 22 protecting members of the public as well as the 23 environment. I 24 In contrast to that, the EPA program we 25 characterize there as a bottoms up approach. This is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W. (202) 2344433 WASHINGTON, D C. 20005 (202) 234-4433

17 1 a very crude comparison because we're talking in EPA's 2 case about many statutes, many different regulatory 3 programs and often times we find that their programs, 4 are, of. course, driven by the statutory language. 5 Some cases they can consider practicality and 6 technological feasibility. In other cases.it's an 7 absolute risk standard that's driven by the 8 legislatic, 9 So, in EPA's

case, we often find 10 rulemaking that would establish what-would be 11 perceived as more restrictive requirements or better 12 levels of protection and then the application of 13 practicality concerns or technological feasibility 14 often comes in either through the regulation itself in 15 considering things like what is best demonstrated t

16 available technology, as well as in the permitting 17 process or things like that where perhaps the absolute 18 level established in the regulation is not attained 19 but something that EPA finds acceptable is and that's 20 done within the context of the regulatory framework. 21 COMMISSIONER de PLANQUE: The primary 22 cause for this stems from the original legislation, 23 the language in the original legislation? Is that 24 the -- ^ 25 MR. WEBER: I think that's the driver of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. j (202) 2344433 ~ WASHINGTON. O C. 20005 (202) 2344433 i

18 1 the programs, of course this has a long history and 2 often times the lod, 10 risk framework that we often 4 3 hear spoken about in terms of the EPA's drinking water I 4 program, the Superfund Program, the Clean Air Act now, 5 those programs can trace their concentration on that 6 risk range back to the delaying clause and de Einimis 7 concepts that were derived from those earlier legal 8 constructs. 9 MR. MALSCH: Just to add something. In 10 the case of some statutes, EPA regulation is not even 11 risk-based, it's based upon technology. So, whatever 12 risk level it achieves is sort of coincidental. In 13 one area that you can make a direct comparison, Clean 14 Air Act regulation, you can actually look at'-- they 15 have a two stage regulatory process that corresponds 16 pretty closely to our two stage process, adequate 17 protection and we have safety enhancements above 'that. 18 They have something like that. There you can draw 19 exact comparisons because the language is somewhat 20 similar. But once you get outside comparable 21 programs, it's very hard to draw comparisons. That's 22 why this is very, very crude. i 23 MR. WEBER: (Slide) If we turn to the 24 next slide, you'll see the variety of programs that' 25 the staff focused on as part of our analysis or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4 33 WASHINGTON, D C. 20005 (202) 234-4433

19-1 comparison of risk-assessment techniques employed by 2 the'two agencies. I won't run down through all those 3 different regulatory areas, but what we're attempting 4 to do is to have a broad enough scope so that we would 5 get a sense of how varlous non-radiological programs. 6 might also influence EPA's decisions in rulemaking-7 actions or implementation actions that would affect 8 radionuclides in the environment. 9 For example, often for consistency reasons 10 EPA would prefer to ensure that waste disposal 11 activities do not end up violating requirements set 12-under the Safe Drinking Water Act. Even though those 13 requirements may not have been specifically set for 14 radiological protection purposes, nevertheless for 15 consistency there's a policy driver there to attain a 16 comparable level. So, where some of these influences 17 may come from non-radiological programs, we wanted to 18 be sure that they were included within the scope of f 19 our comparison. 20 COMMISSIONER REMICK: Do you have any way 1 21 of judging how consistent they are in these various 22 programs, realizing that some it's driven by statute? i i 23 I realize we're always consistent with home we -- and -l 24 so forth and I was wondering how they compared us. 25 MR. TAYLOR: I want to be sure that went NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234 4433 WASHINGTON. D4. 20005 (202) 234-4433 i

20 1 on the record, sir. i 2 MR. WEBER: I think it's fair to say that 3 both agencies are not consistent and that is what 4 we're getting at in what we're doing now in the risk-5 management area because that's where we're looking at 6 risk objectives. But as we'll see later on, it is 7 difficult. It's one thing to be able to compare what 8 are the stated risk objectives. It's another matter-9 to be able to estimate or evaluate what level is 10 actually being achieved. That's a complex undertaking 11 and I hope we can get to that. 12 COMMISSIONER CURTISS:- Mike, in the list 13 of programs that you looked at at EPA, did you look at 14 EPA's groundwater policy as a discreet regulatory 15 topic or is it captured somewhere in these topics that 16 you looked at? 17 MR. WEBER: I think it's captured'in the 18 program under the Safe Drinking Water Act. As you ' re l 19 aware, the groundwater protection strategy that EPA 20 has outlined primarily references back to those 21 drinking water protection standards or the maximum 22 contaminant levels as the points of reference with 23 respect to implementing that program. So, that 24 becomes the driver in things like the draft low-level 25 waste protection standards and the alternate ~ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON, D C. 20005 (202) 2344 433 .I

21. 1 concentration limits for uranium mills. 2 COMMISSIONER CURTISS: Is the groundwater l 3 protection strategy itself a regulation or a policy 4 that implements a particular statute or --- 5 MR. WEBER: No. 6 COMMISSIONER CURTISS: What does it spring 7 from? 8 MR. WEBER: I think the motivation for 9 EPA's development of that was a recognition back in 10 the '80s-that EPA was not dealing with groundwater 11 protection in a consistent fashion. So, as a policy 12 matter, they sought to develop an approach that would j 13 enhance or foster some consistency between the various r 14

programs, principally the Hazardous. Waste Program 15 under the Resource Conservation Recovery Act, the 5

16 Superfund Program, various activities like that. 17 COMMISSIONER CURTISS: But the groundwater 18 protection strategy and the risk levels reflected 19 therein are not driven by any particular statutory 20 requirement. 21 MR. WEBER: That's right. 22 COMMISSIONER CURTISS: Is that a fair 23 statement? 24 MR. WEBER: Yes. ~ 25 MR. BANGART: In fact, the EPA indicated r NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N.W. {202) 2344433 WASHINGTON, D C. 20005 (202) 234 4433

23-1 that with the flexibility that they now have, and if 2 _they can implement a consistent program throughout the 3 states and across the country, then it would eliminate 4 the need for legislation that would drive the program 5 and they're comfortable with that kind of an approach. 6 COMMISSIONER CURTISS: I was really 7 picking up on -- and that's a key point. I was 8 picking up on Marty's earlier comment that in some of 9 these cases the risk level is pretty well established 10 in the statute itself. The Clean Air Act, as 11 interpreted by the courts, is probably -- 12 MR. MALSCH: Not so much risk level. In 13 fact, actually the first I've ever seen of risk level 14 actually established-in the statute was in the recent 15 Clean Air Act amendments. What I really meant to 16 refer to would be a statute which directed regulation 17 based upon risk management as opposed to regulation 18 based upon technological availability or some other 19 kind of a concept. See, if you can fashion a program 20 based upon, let's say, best available technology, you L 21 end up with risks, but what you end up with is sort of 22 a coincidental because it's driven by the technology, 23 not risk management concepts. 24 COMMISSIONER CURTISS: The challenge that 25 we face in the Clean Air context, of course, is ~ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON, D C. 20005 (202) 234-4433

-e 33 1 dealing with what has been construed by the courts and 2 explained by EPA as a statutorily mandated level, 3 quantitative level of protection, and the distinction 4 that I'm attempting to draw is that in the case of the I 5 groundwater protection -- back up. And hence, very. 6 little flexibility on their part in terms of how they 7 interpret that, what they call a fuzzy bright line. 8 In the context of the groundwater protection strategy l 9 which is in turn an issue implicated in a lot of the t 10 areas where we have disagreements with EPA, the degree 11 of constraint is much less at least insofar as the 12 statute is concerned because it's not driven by the 13 statute. 14 MR. MALSCH: Yes. I'm not aware that the 15 particular risk management levels chosen by EPA for 16 its groundwater strategy were actually dictated by 17 statute. I 18 COMMISSIONER CURTISS: All right. 19 MR. WEBER: In f act, I believe the EPA has 20 consistently maintained that - it is through other 4 21 rulemakings where EPA does have statutory authority 22 that they would seek to implement that strategy. And, 23 in fact, we see that in the mill tailings area, in the - 24 draft low-level waste standards, in the high-level 25 waste program. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE 8SLAND AVEN!)E, N W. (202) 234-4433 WASHINGTON. O C. 20005 (202) 234-4433

1 24 1 I should point out that in the comparison l 2 of the various programs, the staffs focused on routine 3 operations for_the most part. So, we did not consider 4 severe accidents or things like that. We also focused 5 on public or environmental protection as compared to 6 occupational protection. This was done for the most t 7 part because it helped us pare down the problem so l t 8 that it was manageable. As you're well aware, the 9 regulations that both agencies have are very diverse 10 and comprehensive and it would be a very formidable 4 11 task to try to tackle that in one shot. i 12 (Slide) If I could have the next slide, 13 please. 14 We completed the comparison last year and 15 in a briefing last November we identified a variety of l 16 similarities. It was a joint briefing by both the EPA I 17 staff involved in_the Office of Radiation and Indoor 18 Air and our own staff. These are very approximate 19 statements of what the conclusions of that comparison 20 were. There's more detail, some more detail, in the r i 21 Commission paper. There's even more detail in the 22 briefing charts that were used for that briefing. But 23 I'll try to go through these and stop me if you've got 24 questions. 25 The first one was that both agencies NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. 1202) 2344433 WASHINGTON, D C. 20005 (202) 2344433 ~l I ~

r 25 j 1 generally use deterministic risk assessments. As 2 we've already talked about, a decreased emphasis on 3 looking at the probability of some of the exposures, 4, as maybe driven by failure of-various components. 5 Of course there are notable exceptions to 6 that. For example, the high-level waste standards are 7 probabilistic in nature because they deal with the 8 containment requirements and there is probability 9 incorporated directly in there. There are also such l 10 things in our own program, for example under Appendix 11 I of 10 CFR Part 50. The standards for effluence, the-12 design objectives were based on technology, what 13 technologies were available at the time, and then the a 14 risks associated with it or the doses in that case 15 were then back calculated based on what technologies 16 could achieve. 17 The second one, both agencies generally maximally exposed 18 assess exposure to reasonably 3 19 individuals and usually consider the same exposure 20 pathways. Again I'd have to caveat by saying that in 21 high-level waste, certainly for things like the I 22 carbon-14 element of the containment requirements and 23 other areas, it's not always true that it was set 24 based on exposure to a maximally exposed individual. 25 I'd emphasize we use the word " reasonable" there NEAL R. GROSS COURT REPORTERS AND TRANSCRISCnS 1323 RHODE ISLAND AVENUE N W. (202) 2344433 WASHINGTON. D C. 20005 (202) 2344433 .~,

P .26 1 intentionally to reflect that in all cases we're not i 2 using worse case assumptions.- What' we generally 3 attempt to do both agencies, is look at it and 5 l 4 attempt to create a scenario of exposure.which would 5 reasonably bound but not capture perhaps the upper 6 five percent or so of the distribution of exposures. 7 Generally the -- 8 COMMISSIONER REMICK:. Excuse me, Mike. 9 What is the apparent lack of interest on both the NRC 10 and EPA to go to the critical group concept? 11 MR. BERNERO: I think what happens, if you l 12 use maximally exposed individual without reasonable in 13 front of it, there is a tendency to need the critical 14 population group as a more representative limit. Our 15 agency and EPA, as a matter of modeling practice, are 16 using a reasonable choice for the maximally exposed 17 individual. There's a lot of latitude there and 'f 18 that's why there is less interest in or need for 19 consideration of using a population group as against i 20 an individual. It's really a matter of -- there used 21 to be a tendency of using the fencepost cow or the 22 fencepost goat around a reactor station, taking the 23 worst theoretical person and not real. person. When 24 you do that, that's when you need the moderation that. l 25 you get with a critical population group. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202)1044433 WASHINGTON, D C. 20005 (202) 2344433 I .i

27 1 COMMISSIONER REMICK: But reasonable, of-l 'i 2 course, is in the eye of the beholder. .l 3 MR. BERNERO: Yes, it is. 4 COMMISSIONER REMICK: How have we used i 5 reasonable? Have we used it in any cases? 6 MR. WEBER: Well, for. example, I can think 7 of one recent case and that's the development of our 8 methodology to convert residual reactivity levels into 9 doses, the NUREG-5512 effort that we have through our 10 Office of Research and Pacific Northwest Labs.- There 11 we attempted to identify parameters that would define r 12 -- it would be a conservative representation of how f 13 someone may be exposed, but it would not be the 14 ultimate maximum exposure. For example, you wouldn't 15 assume that somebody is going to eat perhaps ten times 16 what a typical individual would ingest in '. terms of 17 plants grown on site or in terms of meat that might be i 18 produced on site. 19 COMMISSIONER REMICK: How about location? f 20 How do you determine the location'of an individual 'l 21 for -- I 22 MR. WEBER: That depends on the program. 23 Certainly for something like effluence, you may choose 1 24 the closest location that somebody could live to the 25 site while the site was operating. In contrast,-in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WASHINGTON. O C. 20005 (202) 2344433

.38 1 the decommissioning area, you might choose a location 2 that would be right on the contamination. So, it's 3 going to vary from' site to site. 4 COMMISSIONER REMICK: And if you expose 5 the person that could live the closest, isn't that the -l 6 maximally exposed individual -- well not necessarily,- 7 depending on plumes and so forth. But in general, it l 8 would be. 9 MR. BERNERO: Well, Commissioner, the real 1 10 test ~of it is when you're doing it, when you do such 11 an analysis, if there is reasonable judgment in 12 selecting a maximally exposed individual,.you ought to 13 be getting the same sort of result you get from a 14 critical population group. For instance, when we're i 15 doing calculations of decommissioning

residues, 16 assuming a factory is built and workers are in that 17 factory, you should get nearly the same result from 18 the maximally exposed individual or from the average 19 of the workers in the factory.

I think it's a fair. 20 thing to say that we are using modeling techniques 21 that will come out fairly close together and therefore .I i' 22 it reduces the need. 23 COMMISSIONER REMICK: I guess I don't 24 understand how you say if you-take the maximally or 25 the average how it's going to be the same. -I don't ^ -! NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4A33 WASHINCTON, O C. 20005 (?02) 234 4433

29 1 understand that. 2 MR. BERNERO: Because by -- the way it was 3 chosen. One is not choosing a worker who would work 4 in the factory and be a resident night watchman as 5 well and somehow or other get 24 hours a day exposure, 6 whereas the typical worker would only have eight hours 7 a day or nine hours a day exposure. 8 COMMISSIONER de PLANQUE: Try as an 9 example the situation where a child might be much more 10 radiosensitive to the particular element you're 11 talking about. In that case, would the child be the t 12 reasonable maximally exposed individual?- 13 MR. BERNERO: I don't think we do. i 14 MR. WEBER: In most of those programs we 15 looked at a lifetime of exposure. So, that would 16 capture the full range on radiosensitivities and that 17 would be reflected in the risk coefficients that we 18 would use. i 19 What we did is compare what the agencies 20 have done over the years-because this has been 21 developing over the last two decades. That's not to 22 mean that we will come out of this saying, "Yes, let's i 23 keep doing what we've been doing." In f act, as we get 24 together, we may identify the need to go with more of a critical group type concept. 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON. D_C. 20005 (202) 234-4433

30 1 COMMISSIONER REMICK: Am I correct the 2 only way in which we come close to.using critical 3 group was in the safety goal policy statement? 4 MR. BERNERO: To my knowledge that is. 5 The ACNW regularly recommends it to us. 6 COMMISSIONER REMICK: Yes. 7 MR. BERNERO: But to my knowledge that's 8 the only place where we have used it. 9 MR. WEBER: One other concern that has 10 been raised about the use of a critical group concept 11 is that by its very nature looking at the average 12 exposure to the critical group means that somebody is 13 going to be exposed to a higher risk. 14 COMMISSIONER REMICK: That's right. 15 MR. WEBER: And some people find that -- 16 COMMISSIONER REMICK: And somebody's going 17 to be lower. 18 MR. WEBER: Right. 19 COMMISSIONER CURTISS: If I could just l 20 take a topic that's on our agenda right now in the 21 high-level' waste area. If we were to move to an 22 individual dose

standard, which is one of the 23 considerations that the Academy is looking at in fact 24 this very week, are the differences that you've seen 25 in our historical approach to this issue so minimal l

l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON. D.C. 20005 (202) 234-4433 l

4 31 1 that you would expect -- and I realize I'm asking you that we and EPA could reach 2 to speculate here 3 agreement on issues such as the point of exposure and 4 uptake pathways, what have been referred to as the 5 static biosphere questions? Are we close enough to 5 6 reach agreement on that? 7 MR. BERNERO: Let me speak to that because l 8 that has come up already. You may be familiar with it r 9 that in the, oh, past month or so, a little over a 10 month, the staff reviewed the Energy Policy Act of 11 1992 and possible impacts on the high-level waste 12 standard and had a dialogue with the Advisory 13 Committee on Nuclear Waste and they wrote a letter and 14 this very issue came up. The Advisory Committee, not l 15 surprisingly, said, "You really ought to focus on the 16 critical population group as against the individual .j 17 risk for that issue." 18 What you have just said, Mr. Commissioner, l r 19 is the big uncertainty is not whether one is doing the 20 critical individual or the critical population group. t 21 In the staff's view, the big uncertainty is what is I 22 the biosphere for reference purposes? How are we 23 going to model this thing if you're speaking of a' dose 24 out over say a 10,000 year period? I can only suggest 25 that yes, that.is something that would have to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W-. (202) 234-4433 WASHINGTON. O C. 20005 (202) 234-4433

33 1 developed a clear consensus on such modeling, that is i 2 the dominant uncertainty. It - is the uncertainty 3 already prevalent in all foreign programs because i 4 foreign high-level waste programs aren't all based on 5 dose to an individual as against release quantities 6 such as we have in the U.S. I 7 So, it's a formidable task, but it's one 8 that's already on the table for all the -other. 9 programs, foreign programs, and I'm confident we could 10 deal with it. It won't be easy, but we could deal 11 with it. 12 COMMISSIONER CURTISS: Okay. j 13 MR. WEBER: One other important similarity 14 here is that in some cases both agencies have saw fit i 15 to protect a real person as compared to a hypothetical 16 person. For example, EPA standards under 40 CFR 190 17 are designed to protect an actual person rather than 18 a hypothetical person. The same can be said for our 19 requirements, the public dose limits under Part 20. t 20 Moving to the third similarity, both 21 agencies translate exposures and intakes into doses 22 and risk using internationally accepted techniques 23 generally.. To get back to our earlier discussion of 24 this

point, certainly NRC has followed the 25 recommendations of, to a great extent, the National NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N.W.

(202) 234-4433 WASHINGTON, D.C. 20005 (202) 234-4433

33 1 Council on Radiation Protection Measurements, the-2 International Commission on Radiological Protection, 3 other advisory groups or scientific peer groups like P 4 UNSCEAR, BEIR IV and the BEIR V Committee. 5 EPA generally has done the same. However, 6 in some of their programs, for example, we recently 7 reviewed the draft -- or the proposed drinking water 8 standards for radionuclides. In those cases, EPA saw 9 fit to develop their own dosimetry and their own 7 10 modeling to estimate the risk associated with the 11 intake of radionuclides from drinking water. They. 12 felt that they were doing the best science based on 13 the epidemiological work that had been done. That 14 does, however, take them away from some of the risk 15 coefficients and dose conversion factors that are 16 included in their own federal guidance to the-other 17 agencies, like Federal Guidance Report Number 11. 18 We, in fact, had.a meeting with the EPA 19 staff on this and so earlier this year the similarity 20 is that by and large we both subscribe to these 21 recommendations, but there are some differences, and l 22 we experience those diffe.rences in the various program 23 areas. j J 24 Both agencies assess risk primarily in 25 terms of cancer f atalities or in terms of mortality as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. .f (202) 234 4433 WASHINGTON. D,C. 20005 (202) 234 4433 e-rwp

34 1 compared to morbidity. Once again, there are some 2 exceptions. In the Superfund program the risk range 3 is applied for morbidity so that for radiological 4 exposures that would include both f atal. cancers as 5 well as nonfatal cancers. There's a lot -of 6 uncertainty and controversy associated with that 7 approach because that will vary based on the cure rate 8 and various other medical treatments that are 9 available, how early is the cancer detected and things 10 like that. 11 Both agencies also sorietimes truncate risk 12 assessment, so the similarity here is that, yes, in 13 certain cases Le have truncated, however there is also.. 14 a difference. And when I talk about truncation here,- b 15 I'm referring to deciding at some distance from a 16 facility or at some time into the future to stop l 17 counting the exposures or the risks-based on the 18 recognition that as time ' continues certainly the l 19 uncertainties associated with making long-tern 20 projections of the risks or the doses increases 21 substantially so that at some point you come-to the i 22 point where it's questionable ~ whether you can justify l 23 looking beyond a certain time period. 24 COMMISSIONER REMICK: When I read that,. 25

Mike, "both agencies sometimes truncate risk NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.

(202) 2344433 WASHINGTON, D.C. 20005 (202) 2344433

35 1 assessments," I was reminded of the saying, "Old Bill 2 Bailey goes to work daily, sometimes." That means 3 sometimes he doesn't too. 4 How consistent are we in our truncating 5 out in distance? I was under the perception that a o 6 few years ago at least sometimes we would go out and 7 integrate out to 250 miles around the reactor and 8 sometimes 50 miles. Of course, the Safety Goal Policy 9 Statement basically says, for cancer, out to ten miles 10 and for prompt fatality one mile. How consistent are 1 11 we, do you know, within the Agency when we're thinking 12 about distance? 13 MR. BERNERO: Well, I would say in general 14 tne principle that people try to follow in truncation 15 is, if it's the tail of a curve where I have 16 calculated in the first 50 miles, say, the predominant 17 impact, there is little justification to calculate out 18 to a. greater radius as long as it's the tail of the 19 curve and the dose calculated is not a significant 20 addition for the purposes of the calculation. Then I. j 21 can truncate, because I have the essential story or 22 the essential facts already. 23 Where you run into a difficulty is where 24 collective dose is itself the objective and the High-25 Level Waste Standard is the classic example of that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON. D C. 20005 (202) 234-4433

36 i 1 where it is collective dose that is the primary _. f 2 standard and therefore one does not truncate, except, 3 as in high-level waste, one truncates at 10,000 years 4 for the reasons evident in that proceeding. There we 5 are not consistent. I should say, that is a non-6 truncation case that is quite different, but it has a 7 reason and that's where much of the controversy comes. 8 I don't think we have differences where 9 either agency is calculating a point source diffusing 10 from, say, a single reactor station or something like 11 that,. a point source going out where you could do a 12 ten mile radius or a 50 mile radius and get the bulk 13 of the impact and therefore reasonably truncate going 14 beyond that point. But where collective dose is 15 itself the object, I don't think we are entirely 16 consistent and we would tend -- 17 COMMISSIONER REMICK: Unless you-have it 18 cut-off. 19 MR. BERNERO: Yes. The NRC would tend to 20 say you need to have a different risk perspective cn 21 use of collective dose and, of course, the High-Level 22 Waste Standard, that is one of the long-standing 23 criticisms, this comparison to other risks and so 24 forth. 25-MR. WEBER: (Slide) Could I have the next NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234 4433 WASHINGTON. D C. 20005 (202) 234-4433

r 37 1 slide, please? 2 Turning now to some of the differences 3 that we identified, certainly the use of risk 4 assessment in the agencies is somewhat different based 5 on our differences in mission. 6 In the radiological area, EPA's mission is 7 primarily one of developing standards. In contrast, 8 NRC's program includes both rulemaking to implement 9 generally applicable standards and other requirements 10 as well as the implementation of those requirements l 11 through licensing and various other regulatory 12 reviews, so our programs tend to use risk assessment 13 more in terms of compliance determinations or 14 implementation aspects. EPA's generally are applied 15 more to support generic actions like rulemakings. .l 5 16 Of course, as I pointed out, both agencies 17 have their share of rulemakings and EPA also has 18 implementation responsibilities in programs.like the 19 Hazardous Waste Program, the Drinking Water Programs, 20 Clean Water Act Programs, things like that, so they 21 too do site-specific risk assessments. 22 Both agencies use risk coefficients for 23 converting doses into

risks, however the risk s'

b 24 coefficients that are used vary. When we put this ^ together at the time last November, NRC was using a 25 NEAL R. GROSS 2 COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON, D.C 20005 (202) 234 4433 i

38 1 risk coefficient for low LET ionizing radiation of 4 d 2 about 5X10 fatal cancers per person rem. In contrast 4 3 to that, at the time EPA was using 4X10. So at that 4 time there was a difference in the risk coefficients 5 for converting dose into risks, however EPA generally 6 prefers at least today to go directly from the intake 7 of the radioactive material to a risk and therefore 8 bypass the dose altogether except in those programs 9 where dose is an important element of a compliance 10 determination. And so, they're using in some ways 11 more sophisticated modeling to relate the intake of 12 the radionuclide to a risk by looking at organ-13 specific risk factors and age-specific risk factors. 14 What I'm trying to get at is they're l 15 relying less on some lumped risk. coefficient like 4 16 we've used, 5X10, and instead preferring a more 17 sophisticated analysis to relate the dose to the risk l t 18 or the intake to the risk. So, that's one of the i 19 differences that you-were asking about earlier. 20 COMMISSIONER REMICK: I remember back when l 21 the Commission was reviewing the BRC policy statement 4 22 I asked the staff the question why we're using SX10 t f d 23 rather than 4X10 and the staff made a very. strong 4 24 defense of SX10. What's EPA's excuse for using 4X10' 4 d 25 ? At that time, I. read BEIR V saying 4X10. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON O.C. 20005 (202)2344433

39 1 MR. WEBER: I'm probably not the best 2 person to answer that, but what I am aware of is that 3 EPA believes, because of its mission and its statutory 4 responsibilities, that it independently needs to 5 develop conclusions on the risk associated with 6 exposure to radiation. And therefore, when it gets a 7 BEIR V report it will scrutinize that report and I f 8 think with that scrutiny there's the expectation that 9 they may come out at a different-place. They also t 10 rely on data that I'believe the BEIR V committee did 11 not place a great deal of emphasis on. 12 Did you want to say something? 13 MR. BERNERO: Yes. I just wanted to add, 14 I was trying to allude to that much-earlier in the 15 briefing. The EPA looks at a BEIR V report as a base i 16 of comparison for what they're doing to see if they're 17 generally in agreement, whereas we are tending to use l 18 it as a reference. j 19 If I recall correctly, when we had the 20 discussion of 5 versus 4 in using BEIR V directly, I 21 believe there was an age of the population i 4 22 interpretation that was necessary between 5 and 4. 23 COMMISSIONER REMICK: And I think somehow i 24 age related to workers or something else. ~ 25 MR. BERNERO: Yes, but I don't think that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON, D C. 20005 (202) 234-4433 i i

40 1 pertains to the EPA usage. The EPA usage is actually 2 independent of BEIR V and only compared to it. 3 COMMISSIONER REMICK: I see. I 4 MR. AUSTIN: If-I could add to that, one 5 should recognize that when we went into this 6 comparison it was with the idea of trying to identify 7 differences that could influence the decision. That 8 is, if we both did an analysis, would one agency i 9 conclude one thing and the other something different? 10 And I think the message is here that we didn't really 11 find in most cases any significant difference that 12 would influence the decision. 13 COMMISSIONER REMICK: Yes, I understand. 14 It just seemed like a unique opportunity with a group 15 of experts around here to explore some of these things 16 that are in the back of my mind. 17 MR. BERNERO: I'd like to have Doctor Cool 18 from the Office of Research speak to it. He is an 19

expert, j

20 COMMISSIONER REMICK: Fine. Okay. l 21 DOCTOR-COOL: Good afternoon. I'm Donald j 22 Cool with the Office of.Research. 23 At the time we_were holding the discussion 24 that you referred to, the BEIR V report and the-l 25 UNSCEAR report had just come out. EPA's 4X10 value ) 4 NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON, D.C, 20005 (202) 2344433 i

41 1 was based on where they had been prior to coming out 7 2 with those reports. Since that time, they.have been 3 taking a relook as we had taken our relook in the same 4 time frame and two things come out of that which I 5 think are relevant here. r 6 First of all, they do prefer to use organ-7 specific numbers rather than going to a sum total. l t 8 They sort of dislike going to a single bottom-line I 9 number. But if you add all of those values up at this 10 point, they would end up, if you pushed them to it, to 11 a number which is now in fact very close to 5 also. L 12 They have adopted nearly an identical methodology to i 13 what we have in our NUREG-4214, the health effects 14 criteria associated with accident-analysis,._ so that 15 has actually come more closely together since the time 16 of those discussions two years ago. 17 COMMISSIONER REMICK: Thank you. 18 MR. WEBER: Another difference that was 19 identified is that there are differences-in. the 20 assumptions made in terms of long-term exposures-of 21 members of the public or the environment. These are 22 things like to what extent is inadvertent intrusion l 23 considered. You're probably all aware in the 24 Hazardous Waste Program inadvertent intrusion isn't-25 even considered, whereas in our Low-Level Radioactive NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l 1323 RHODE ISLAND AVENUE, N W. j (202) 234 4433 WASHINGTON. D.C. 20005 (202) 2344433 Y

43 1 Waste Program the requirements themselves are based on 2 assessments which contemplated intrusion into the 3 waste and in fact that was the basis for developing 4 the waste classification

system, so there-are 5

differences of that nature. 6 There are differences in terms of how long 7 is the person assumed to be exposed to the' 8 contaminant. Many of our programs assume a 70 year L 9 lifetime, therefore the person would be exposed for 70 10 years. EPA generally uses 70 years, but in some-11 programs, notably the Superfund program, they've now 12 gone to 30 year exposure, which of course if you're 13 looking at the risk, that's a factor of two when you' r 14 implement the assessments. 15 There are other differences such as the j 16 reliance on institutional controls. NRC generally 17 tends not to rely ~on institutional controls after a 18 certain point, for example 100 years. ' EPA, in some of. 19 their programs, takes the same approach. In other 20 programs, however, they place greater reliance on 21 institutional controls. Just like we were. talking i 22 about inadvertent intrusion for a hazardous waste j + 23

site, the -same can be said for. reliance on

'I 24 institutional controls. There's a presumption.that 25 the deed restrictions and other constraints that will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON, D C. 20005 (202) 2344433

43 1 be placed on a property after it's been used for land 2 disposal of hazardous wastes will remain effective on 3 into the future. That earlier assumption has not been 4 found to be acceptable in our rulemakings on low-level 5 waste and other programs. 6 COMMISSIONER CURTISS: Mike, is there a 7 clear practice at EPA insofar as how they handle human 8 intrusion? Do they -- and here more specific in my-9 question. In establishing requirements, for example, 10 for the stabilization of hazardous waste sites ~ or 11 other activities of that

nature, do they in 12 establishing those requirements assume and permit 13 reliance on institutional controls to prevent human 14 intrusion at some subsequent point, in particular way 15 out in the long-term horizon?

16 MR. WEBER: Yes. I think that's an a 17 implicit assumption in.their regulatory program. - They - 18 haven't come out and said that per se, but certainly P 19 to the extent that inadvertent intrusion is not 20 considered in designing a facility or looking at the 21 wastes that are going into the facility, barriers are .22 not constructed. The only thing that remains after 23 the facility has been closed are those institutional 24 controls, to prevent human intrusion. 25 COMMISSIONER CURTISS: Okay. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON, D C. 20005 (202) 234 4433

44 1 MR. AUSTIN: We actually have a case now 2 that eventually will come to the Commission where it 3 is a RCRA site being closed at which thorium has been 4 buried. The question it if the license had not been 5 terminated, we would have to make a determination of 6 unrestricted use at a site where EPA tells us there 7 will never be human involvement again. In that case, 8 eventually we'll be coming to the Commission. It 's an 9 interesting -- 10 COMMISSIONER CURTISS: That issue is, of' 11 course, at the heart of the Academy's review of the 12 high-level waste issue and the question of the 13 reasonableness of relying on institutional controls to 14 prevent human intrusion is a very complicated one, but. 15 it sounds like the practice has been all over the map 16 at least at EPA and perhaps within our own agency on i 17 that question. 18 MR. WEBER: In other programs, for example 19 our mill tailings program, there is_ reliance on 20 institutional control in perpetuity. Not to the 21 extent that you would decrease the level of protection 22 in terms of the radon barrier or the rock rip-rap for "l 23 erosion protection, but certainly land ownership and 24 preventing somebody from going on the site and ~ 25 building a home, things like that. [ NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON. D C. 20005 (202) 2344433

45 1 Other differences that we identified, 2 NRC's risk assessments generally focus - on limiting 3 individual risk. EPA risk assessments will look at 4 usually both individual risks and population risks, 5 especially where those population risks, they believe, 6 determine which control option is preferable. We got 7 into that a little bit before about collective dose 8 and critical population group and the carbon-14, I 9 think, is a good example of that. 10 NRC typically uses radiological dose for 11 both its rulemaking activities as well as 12 implementation and compliance assessment. EPA, in 13 contrast, typically today relies more on health risk 14 than a radiological dose. That's certainly evident in 15 the Superfund program and drinking water program where 16 the driver is the risk determination and then that 17 risk is then back calculated into what the resulting 18 dose would be. 19 COMMISSIONER de PLANQUE: But by and large 20 in the radiological area the results ~ should _ be the 21 same except for the few cases you pointed out,.the 22 example being LET. 23 MR. WEBER: Right.

However, it is-24 important to point out, at least based on what Doctor 25 Cool said earlier and EPA's ongoing assessment of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBE 9S 1323 RHODE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON, D C. 20005 (202) 234-4433

t 46 1 organ and the age-specific risk factors, that in some 2 cases their risk coefficients may be considerably less 3 than the ones that we're currently using. One case 4 comes to mind and that's for thorium-232. I believe 5 the difference in the risk factors is on the order of 6 140 times, which may have significant implications in 7 terms of how either agency proceeds..In fact, EPA.is 8 now looking at its whole approach.on converting dose 9 and risk as part of their drinking water standards.- l 10 So, we're going to watch that closely and interact i 11 with them so that we're sure we're kept abreast of 12 what they're doing. { 13 COMMISSIONER REMICK: Mike, I'd like to go 14 back a minute to make sure I understand the statement 15 you made about EPA. I think you said they implicitly I 16 rely on institutional controls. Now, am I correct in 17 adding to that passive institutional controls? I 18 could interpret institutional controls being guards or 19 an agency patrolling and so forth. Are you including 20 that or are you talking about deeds, restrictions and 21 things like that? 22 MR. WEBER: They're passive, but to remain 'l 23 effective there has to be some active body there 24 that's empowered to enforce things like deed 25 restrictions. If the deed restriction includes 4 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON. D C. 20005 (202) 234-4433

47 I consultation with an agency, there would have to be 2 the reliance on that consultation to ensure that that 3 restriction was carried out and'the protection were 4 achieved through the application of that control. But 5 if you define passive controls as things like deed t 6 restrictions, restrictive covenants, things like that, [ 7 yes. That's to prevent against inadvertent intrusion. 8 Certainly_the RCRA landfills are designed to minimize 9 infiltration and to minimize transport. of the 10 contaminants after the operation of the facility. 11 COMMISSIONER CURTISS: As you 've described 12 it, it sounds more like an active institutional 13 control than a passive one. 14 MR. WEBER: Right. Well, I think what 15 we've found all throughout this discussion with EPA is r 16 that you have a spectrum. Some institutional controls i 17 are more active than others. But when you're racking 18 them up against each other, you may find that they're 19 both more or less an active type control. l 20 COMMISSIONER CURTISS: And at least' l 21 insofar as those active institutional controls are 22 applied in the area of hazardous waste under RCRA and 23 Superfund, where the risks of some of the the 24 toxicity of some of the substances continues 25 essentially undiminished over a long period of time as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. l (202)2344433 WASHINGTON. D C. 20005 (202) 2344433 i

48-1 opposed to the diminished radiological risk, would one 2 infer from that that those active institutional 3 controls in that context might suggest they'd be 4 reasonable to rely on in less risky situations? ) 1 5 That's the high-level waste question where the issue 4 6 of active institutional controls is squarely before 7 us. As you compare what is done in the RCRA context 8 for a longer term, essentially unabated risk, is that 9 inferring too much from what you said? 10 MR. BERNERO: We don't have in the NRC, 11 nor do I think EPA has, a consistent approach to the 12 use or reliance upon institutional controls. If you 13 take the uranium mill tailings as a starting point, in 14 uranium mill tailings we look rather strongly at the 15 first couple of hundred years and look long-range _ i 16 toward a thousand year stability of the as-built 17 configuration. We mandate state or federal ownership 18 custody to' avoid interruption or-disturbance of the-19' tailings impoundment. We're making an assumption that.

l 20 it's good enough for a thousand years because-it will 21 be undisturbed and therefore one can reasonably 22 extrapolate beyond that, even though the half' lives 23 involved go far beyond a thousand years.

f 24 The level of risk may be quite reasonable i 25 because if you look at what the consequences of i l NEAL R. GROSS i - COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W-(202) 234-4433 WASHINGTON, D C 20005 (202) 234-4403 I

49 1 disturbance are, it's not the end of the world. It's 2 not a real big release,-real big source term. 3 In contrast, if you look at RCRA, at a 4 hazardous -waste

site, it's not biodegradable 5

generally. The mercury is mercury for centuries, for 6 millennia to come and the time horizon that appears to 7 be within EPA's frame of reference is to look at a few 8 decades really and to assume

custody, deed it's 9

restrictions and what have you will assure 10 really an assumption that one has assured undisturbed 11 performance and that you can rely-on some analysis 12 that shows that there will be no migration from this 13 undisturbed performance that' would cause off-site 14 hazard. 15 It's not consistent with many other areas. 16 In high-level waste, the issue takes on a different 17 complexion. Presumably the risk is high if you do 18 disturb it or get near.it because it is high-level 19

waste, but that's the principal reason you have 20 remoteness.

You're down deep in some geologic i 21 formation. Now the disturbance has to be of a more 22 elegant type, a drilling for resources or massive [ 23 excavation or something like that. [ 4 24 There is no a consistent policy in the EPA 25 or in the NRC for that and it's a major issue really. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WASHINGTON. D C. 20005 (202) 234-4433 e

50 1 MR. WEBER: In fact, to foreshadow a 2 little bit about next -Friday's briefing on _the 3 enhanced participatory rulemaking, one of the things 4 that we quite clearly heard in the workshops by _ a l 5 number of different representatives is that the 6 Commission ought to revisit the _ definition of 7 decommissioning because continued reliance on the 8 unrestricted use requirements may be-in some cases too 9 stringent. In other cases, the thought of releasing 1 10 a former nuclear facility for unrestricted use was 11 implausible. So, that was an interesting observation l 12 that we had in those workshops and you'll hear more 13 about that next Friday. 14 COMMISSIONER REMICK: One further question i 15 on the institutional controls. Has anybody tried to 16 lay out what -- when we say passive or active what 17 were we talking about, institutional controls? Has j 18 anybody laid out the type of things that might be ..j 19 passive, the type of thing -- I get confused, I must 20 admit, as we throw them around. I don't think I 21 understand. I know I don't understand completely. l 22 Has anybody tried to do that? I t 23 MR. BERNERO: I don't_ know of any-i I 24 compendium of that. It might be a constructive thing ~ 25 to do. I hate to invite a mandate. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVENUE, N W. (202) 234-4433 WASHINGTON. D C. 20005 (202) 234 4433 1

J 51 1 MR. WEBER: We did explore that in both 2 the uranium mill tailings rulemaking and in Part 40 3-and EPA did as well in 40 CFR 192. We also did.that, 4 I believe, as part of our Part 61 rulemaking for low-5 level waste where I think we give examples of what we 6 would consider active and what we would consider 7 passive. 8 COMMISSIONER REMICK: It would be helpful 9 if you just give us those past things that have been 10 done. It would help me anyhow. 11 MR. WEBER: We've already talked about the 12 difference there in the bottom. We commonly truncate [ 13 population dose in terms of space and time. EPA 14 prefers to conduct the assessment of the population i 15 dose and only truncate it if they're convinced that' i 16 what the residual is will not significantly. affect - 17 their selection of the control option. j e 18 COMMISSIONER REMICK: This is where we run 19 into the problem though. If you. integrate this out d 20 over great distances and then you're adding up what I-21 might call insignificant doses to a large number of l 22 people, I'm not sure the meaning of it. 23 MR. BERNERO: Unless your focus is on the- .j 24 collective dose itself, that the collective dose 25 integrated at very low levels of radiation over very NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j 1323 RHODE ISLAND AVENUE. N W. i (202) 2344433 WASHINGTON, D C. 20005 (202) 234-4433 --9 I

53 1 large populations is the very thing you're trying to i 2 control. 3 MR. WEBER: Based on the linear dose 4 hypothesis. 5 MR. BERNERO: Yes. That full 6 extrapolation of the linear hypothesis is exactly the 7 issue in carbon-14, high-level waste 8 COMMISSIONER REMICK: I understand, but 9 the uncertainties become so great that I just don't i i 10 believe the numbers. 11 MR. BERNERO: Well, it takes the linear i 12 hypothesis as a very precise line even as it comes to i 13 zero on the graph. i 14 COMMISSIONER REMICK: No, I understand 15 that. But I'm saying when you determine that it's.02 16 whatever, millirem per year or whatever, that might be 17 zero or it might be.04 or.2 and I just don't know -- i 18 adding up' with that great uncertainty in the dose 19 numbers, I'm not sure what meaning it has at all, 20 assuming linear. 4 21 COMMISSIONER ROGERS: Well, logical'ly _ I i l 22 suppose it says that you have to integrate it out to I 23 include every individual.in the wnole world. 24 MR. BERNERO: It does, but that problem 25 has come up time and again. Now, BEIR V or any'other i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON, D.C. 20005 (202) 2344 433 r

53 1 expert group, they will tell you that as you get to 2 ten rem or below ten rem you begin to incur greater 3 and greater uncertainty on the hypothesis. You stick 4 with the hypothesis, but the uncertainty is growing as 5 you go down. And how you're way down on that curve. 3 6 You're almost at the zero and you're getting micro rem 7 to mega people. Adding it all up, like one is 8 building a savings account, it's giving a certainty to 9 a very uncertain impact. But that is the essential 10 question when you're talking about -integrated radon 11 risks from uranium impoundment, mill

tailings, 12 impoundments, when you're talking about the entire 13 concept of the high-level waste standard.

That's why 14 we have said over and over again, try to get some 15 better risk perspective. 16 MR. WEBER: The bottom line in our 17 comparison of risk assessment methods is that although 18 differences

exist, the similarities between the 19 agencies approaches appear to be stronger than the

-20 differences. As John Austin pointed out, it was the 21 attempt to identify-those differences'that may exist 22 that could significantly effect the bottom line. At 23 the time, last November, once we were through the risk 24 assessment ' comparison, it was perceived that the risk 25 management differences would be more significant and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j 1323 RHODE ISLAND AVENUE, N W. l (202) 2344433 WASHINGTON, D C. 20005 (202) 2344433

i 54 1 I think we've seen that to be the case. 2 (Slide) If we can have the next slide. 3 on the risk management comparison, all we 1 4 can say is that we're in the process of comparing the 5 programs. We're comparing the same programs that we. .l 6 looked at in terms of the risk assessment comparison. 7 We're looking at the attributes listed there in terms 8 of the dose or the risk limitation. In other words, 9 is the program driven by a decision that some dose or 10 some risk is acceptable and, if so, what is that? Do 11 we look at an individual risk or population risk? What is the basis for that limitation? Is it 13 statutory? Is it a policy call? Is it based on a f 14 consistency determination with another program within 15 FPA or within NRC? How is that risk objective or dose 16 objective then implemented? Is it implemented simply f 17 as a single statement that that is the level to be 18 achieved or does it come with a whole collection of 19 requirements that add additional levels of protection 20 above that fundamental risk or dose objective? What 21 are the compliance mechanisms in place to ensure or to 22 attempt to ensure that that objective is, in fact, 23 achieved? And finally, under what conditions would ~ 24 the agencies consider exceptions? 25 Those are the areas that we're exploring. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W. (202) 234-4433 WASHINGTON. D C. 20005 (202) 234-4433 i

55 'l 1 1 We have a preliminary table comprised and we're in the 2 process of reviewing that. Once EPA has had another 1 3 chance to look at it, we will circulate that.within 4 the agencies again for staff level revi~ew and hope to-5 complete that in the next couple months. } 6 (Slide) If I could have the next slide, 7 please. 8 Both the efforts on risk assessment and 9 risk management comparisons will provide the basis for i 10 the preparation of the so-called white paper. 'We-11 believe the white paper is important because it will .i 12 provide a foundation for where we go from here in } i 13 terms of risk harmonization, identifying both. a t 14 consistent basis, where are we today as well as 15 setting the groundwork for consideration of where we 16 might want to be tomorrow and what it would take_to 17 get us there. Identifying opportunities both on 18 harmonization of goals, if that's desired, or in-terms 19 of some of these assessment differences that we've i 20 identified. i 21 Also flagging issues that deserve-22 additional consideration. For example, we may not be 23 able to identify that something can be fixed in a 24 particular way or that it should be fixed. Perhaps l 25 we'll embark on a further consideration of those s NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. f <202> 2xu23 wASHiNoTON. o e rocos (2023 234u33 1

56 i 1 differences where they exist. 2 And also to prioritize, recognizing that 3 both agencies in an era of reduced resources need to 4 focus on what's reasonable and in 'so doing I 5 prioritizing those activities that really promise the l 6 greatest potential for harmonization. 7 We hope to have a draft of that white j 8 paper complete late this summer and we'll again be 9 going through the same internal review process to 10 ensure that all the offices within the NRC, as well as 11 the EPA that have a stake here have their chance to 12 comment on that and provide input. We expect that it 13 will probably take longer on the risk management 14 because you do get into things like value judgments, 15 policy considerations, cost benefit _ tradeoffs, 16 technological constraints, things like that. So, it 17 goes beyond the scientific realm and you're getting 18 into some of the more fundamental policy issues. 19 COMMISSIONER REMICK: Assuming once that 20 white paper is finalized, has any thought been given 21 to the advisability of making that available to the 22 National Academy of Sciences studying the high-level 23 waste standard? It seems like it provides some very~ l 24 important background information. ^ 25 MR. BERNERO: No, we hadn't specifically i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON, D C. 20n05 (202) 2344 433

57 1 thought of doing that, but it certainly would be 2 available. It will be a public document. 3 MR. WEBER: (Slide) Could I have the last 4 slide, please? 5 What's the future for the' risk j i 6 harmonization effort? As we've already identified, at i 7 least at this time we perceive that there are more~ l 8 similarities when you look at the programs across the L 9 board in risk assessment than there are differences-1 10 and that the risk management differences appear to be l 11 more significant. Clearly the stated risk objectives 12 of the two agencies differ. We talked about the top 13 down, bottom up comparison, NRC principally being t 14 driven by a risk level on the order of 10-3, coupled 15 with the ALARA concept and other regulatory mechanisms 16 to drive the doses and the risks well down. f i 17

EPA, in

contrast, having a-stated 4

4 18 preference for something in the order of 10 to 10 19 lifetime risk range, although there are differences 20 even within the EPA programs as well may be expected 21 and some of those differences are driven by. statute. I 22 more than anything else. l i 23 COMMISSIONER REMICK: Do they ' ever do .l I 24 comparative risk type of things, what'the meaning of -{ 4 25 a lifetime risk of 10 in comparison to other risks? i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (232) 2344433 WASHINGTON D.C. 20005 (202) 234 4433

58 1 MR. WEBER: They did that -- 2 COMMISSIONER REMICK: I put it in the 3 abstract. 4 MR. WEBER: No, they did that, in fact, in 5 response to the Clean. Air Act issues raised about 6 benzene and vinyl chloride. That's how they-selected 7 that risk range as the presumptively safe level under 8 the Clean Air Act. 9 MR. BERNERO: And one of the things that 10 is even on the table now in the dialogue concerning 11 the Clean Air Act Subpart I, we are in a situation 12 where NRC with the 100 millirem with ALARA may have or 13 appears to have consistency in outcome with'an EPA 14 Clean Air Act standard that would be ten millirem as I 15 a bright line standard. But one has to ask the 16 question if the outcome is the same, is that really i 17 risk harmonization or is that fortuitous, because our I 18 objectives are essentially an order of magnitude 19 apart? That pictorial that Mike showed earlier with 20 the top down, bottom up approach, we have that 21 difference and we are regularly now in the Clean Air 22 Act finding that the outcome may be acceptable to both 23 of us, but the rationale for acceptability is quite 24 different. 25 COMMISSIONER de PLANQUE: Let me follow NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 13?3 RHODE ISLAND AVENUE, N.W. (202) 2344433 WASHINGTON. D C. 20005 (202) 2344433

= 59 -i 1 that one step further. In spite of the difference of 2 the bottoms up and the top down, in spite _of that 3 difference, if you woke up EPA at 2:00 in the morning 4 and you woke up NRC at 2:00 in the morning, would they 5 agree on what they think is safe? The fact that you 6 fortuitously get to the same place so often, if you 7 put the question in those terms, would it be answered 8 the same? 9 MR. BERNERO: I would say no. I would say i 10 no because what we are saying is safe, is 100 millirem 11 a year a very conservatively drawn limit? Anything 12 below it is as reasonably achievable. But push comes 13 to shove 100 millirem a year to a member of the public 14 is safe. I believe the risk objective, the statement 15 in the Clean Air Act is ten millirem.a year, or more 16 accurately three millirem a year is what is safe. 17 What ve're doing is shuffling on cases to see if ALARA 18 gets us to the point where there is a coincidence of 19 objectives or rather a coincidence of results. and 20 that's why we still have a debate about whether or not 21 a regulatory guide has sufficient teeth or strength in 22 its language to make sure it comes out that way rather f 23 than as reasonably achievable. 24 MR. MALSCH: Commissioner, that comes out 25 most clearly if you look at some of EPA rulemakings in i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 *433 WASHINGTON. D C. 20005 (202) 2344 433

60-1 the Clean Air Act where they struggled with defining 2 what is a, in our terms, adequate protection. They 3 use different statutory terms, but it was the same 4 basic objective and they clearly came out with a~ 5 different risk level in so defining than we would. 6 COMMISSIONER CURTISS: Yes. It seems what 7 ve're doing is applying a technology-based component t 8 to our risk-based standard or health-based standard. 9 The technology component being ' how low can you 10 reasonably get it given current technology and cost 11 considerations, which is another way of stating 12 maximally achievable control' technology or best 13 available control technology. I think you're correct, 14 and I share that view, that the underlying risk' 15 question which is in turn the objective of the Section 16 D of the MOU, that effort, the underlying risk 17 question tends to get finessed in that context because i 18 we take advantage of the technology-based character of 19 what could be done to get it down below -- I'm not l l 20 suggesting we ought not to have ALARA. We do and it's 21 a good idea. But it does circumvent or finesse the 22 risk question. We don't have an agreement on what 23 level of exposure is safe. 24 MR. WEBER: The level of protection that 25 the programs achieve, of course, that's a difficult NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS ~ 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON. O C 20005 (202) 234 4433

~ 61 1 question, what is the level of protection that's' 2 achieved. The reason it's difficult is it's, clouded ~ 3 by differences in regulatory programs. In some cases 4 NRC's requirements or EPA's requirements may have a 5 defense in depth type approach so that it goes 6 considerably beyond merely stating, here's the dose or 7 here's the risk objective that you're to attain. 8 ALARA is something that's difficult - to 9 quantify. Often times it's situationally dependent. 10 It depends on what kind of facility you are, how j 11 you're operating, what kind of people you have there, 12 what kind of technology, what are the radionuclides 13 you're dealing with? So, that's difficult to 14 quantify. The level of review is also something that 15 varies between the agencies and, in fact, varies-16 between programs. What kind of licensing or 17 permitting reviews are involved prior. to giving [ 18 somebody a permit or a license? And finally, the t 19 inspection and the enforcement efforts ~ differ. i 20 Certainly EPA doesn't have the luxury of having 21 resident inspectors on many of their facilities, l 22 whereas -- some would consider it a luxury. 23 MR. TAYLOR: Sorry. ( 3 24 COMMISSIONER REMICK: The EDO just gulped. 25 MR. WEBER: In other cases, in EPA's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON. D C. 20005 (202) 234-4433

62 1 programs, there are such things ' as citizen suits, 2 citizen suit provisions in the statutes so that there 3 is a driver there from the standpoint of if members of 4 the public are concerned enough about a facility down 5 the street that may not be operating in compliance, 6 there's a legal mechanism there -to force the 7 compliance. There are also things like the toxic 8 emissions reports that are required under EPCRA for 9 many of the facilities that process materials. t 10 So, all these things complicate our lives 11 in terms of assessing, going beyond the state of [ 12 comparing merely the stated risk objectives and 13 looking at what is the actual level.that's achieved. 14 But we're going to persevere and hope to address those 15 things as part of our white paper and try to shed some 16 light on some of these factors that may contribute'to 17 the overall assessment. 18 MR. TAYLOR: That concludes our 19 presentation. We look forward to this white paper. 20 I'll hold my breath. 21 COMMISSIONER CURTISS: We do too. 22 COMMISSIONER ROGERS: Jim? 23 COMMISSIONER CURTISS: I just have - a 24 couple of questions here. This has been a very good ~ 25 briefing. The background materials that you prepared NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WASHINGTON, Da 20005 (202) 234-4433

63 1 in preparation for this I thought gave us a good-sense 2 of where you.are and where you're going. It's really 3 that later question, where we're going with this, that ~ 4 I'd like you to expand upon. 5 Your schedule to have the draft white 6 paper complete in -- available in summer, this summer, 7 can you expand upon what needs to be done in terms of 8 the steps between now and then to get that done and, 9 in that context, could you address whether this effor-10 is receiving the same level of attention that it's 11 obviously getting here over.at EPA? 12 MR. WEBER: In terms of the steps that are 13 involved in how we move from here and write the white 14 paper, as I mentioned, we have prepared a table that 15 racks out the various programs of both agencies i 16 looking at those attributes that I' discussed. That's 17 in a draft form. It's been around our offices once. 18 It's down at EPA. They still have to fill in some of 19 the blanks and, once we complete that, we can move to 20 the next step of identifying where are we similar, 21 where are we different and exploring why we may.be 22 similar or different. That all provides the grist for 23 the development of the white paper. We've done that 24 on risk assessment and so we have that piece. 'We have 25 the thinking for the most part completed there. t NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERG 1323 RHODE ISLAND AVENUE. N W. (202) 2344433 W ASHINGTON, D C. 20005 (202) 234-=433

64 1 1 We now need to complete the-piecc~on risk 2 management, so, once we complete the table we identify 3 similarities and differences, move on to identifying 1 4 opportunities for pursuing risk harmonization and then 5 writing the paper. .r 6 MR. BERNERO: But I think it's worth 7 speaking directly to your later question about 8 priority. I hesitate to say this in front of the EDO. 9 It appears and has appeared as long'as 10 we've been working on the risk harmonization that the j 11 NRC has a few more resources to dispose to this effort 12 than EPA has and therefore we have-tended to lead or l 13 draw the effort forward, and that's still going on i 14 right now. EPA is trying to participate, 'but in 15 general they just don't have as much horsepower on it 16 as we have. l 17 MR. WEBER: In fact, this effort competes 18 with the same resources that we're cooperating with 19 EPA on the enhanced participatory rulemaking, because 20 the same individuals are involved, so in some ways 21 that's what delayed our efforts earlier this spring. l' 22 MR. BANGART: In fairness though, also, 23 because of prompting by I think all levels of 24 management here in conversations with counterparts in l 25 EPA, they have given it a higher priority than they ^ I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W. (202) 2344433 WASHINGTON, D.C. 20005 (202) 234-4433 I I

65 1 had initially, so they have moved forward at a faster 2 pace in more recent weeks. 3 COMMISSIONER CURTISS: Well, I would hope 4 that we would continue to emphasize the priority of 5 this effort and that EPA in turn would be able to 6 spare resources, and I know they are limited in their t 7 resources because of other activities going on, to 8 support this effort in an active way. 9 In my view, this effort is -really. the i 10 linchpin to the MOU and I'm going to ask a couple of 11 questions in a minute in that regard. It's essential 12 that we come to grips with the issues that are raised i 13 and that we hoped to resolve when we wrote Section D 14 of the MOU. I'm pleased to see that we've finished,. 15 largely finished the risk assessment part of this and 16 concluded in large ptrt that the differences are minor 17 in terms of the outcome or impact on specific 18 initiatives. But in the risk management area, that's l 19 really the key part of Section D of the MOU. 20 That really leads ne to a question that 21 goes to why this is important and what the practical 22 impact is of it. We have several initiatives pending 23 before the Agency right now, in fact a couple pending 24 before the Commission right now that involve specific ^ 25 regulatory efforts. One that comes to mind is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234 4533 WASHINGTON. D C. 20005 (202) 2344433 l l

4 66 I 1 low-level waste standard that EPA is working on. 2 Second that comes to mind is the question of what the '5 3 appropriate risk level ought to be for ACLs where. i 4 we've tentatively endorsed a 10-3 objective in the' 5 staff requirements memo. 6 Recognizing that this effort won't yield 7 a product until later this summer and in addition 8 recognizing that those two issues really involve 9 questions of risk management, the low-level risk-j 10 question and the ACL issue, what would the staff's 11 recommendation be in terms of how we as an agency, and i 12 understanding of course that EPA has got a role in 13 this, how we ought to proceed in addressing 'those 14 issues? Should they be -- I'm inclined to say that' it i 15 would make sense to hold up action on both of those l 16 until we've resolved the risk harmonization issues, 17 the risk management issues that in turn will point the f 18 direction to how to address the low-level waste and 19 ACL question. 20 Alternatively, I guess one could go 21 forward with those prior to the resolution of these 22 issues in the context of Section D, but then one is 23 left asking what's the purpose of the risk management i 24 section of this MOU. But at a minimum, it seems to me 25 that those two issues ought to be treated the same one NEAL R. GROSS I COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON. D C. 20005 (202) 2344433 + a

67-j I 2 1 way or the other. Either we ought to go forward with 2 both of them or we - ought to, as I'm inclined ' to 3 suggest, hold up action on both of them _until we i 4 complete the risk management discussion. 5 Bob? t 6 MR. BERNERO: Well, I would say that we l 7 have differences or regulatory overlap in a number of 'l 8 areas with EPA that are subject to the MOU. In the 9 Clean Air Act, as you know, we are working to resolve i 10 them in spite of the fact that the risk objectives 11 appear to be disparate. And if we can succeed, 12 because I think we should succeed in that, obtaining 13 rescission of those Clean Air Act regulations by EPA, l 14 we are proceeding on that course to do that in the [ t 15 Clear Air Act. t 16 In those other areas where it really boils ' i 17 down to a difference of risk objectives, the MOU also 18 calls for elevation in parallel with the' development -i 19 of this risk harmonization effort and cognizant of 20 this risk harmonization effort and I think that's { 21 really what we need to do. I think we have to take 22 the other areas and pursue them in a fashion 23 consistent with -- we have different objectives. We 24 are working to harmonize this. 4 25 One could argue wait for the white paper, t NEAL R. GROSS j COURT REPORTERS AND TRANSCRIBERS 1323 51HODE ISLAND AVENUE, N W. (202) 2344433 WASHINGTON. D.C. 20005 (202) 2344433

68 1 wait for the ultimate harmonization 'of risk 2 assessment. Could take very, very long and leave'a 3 lack of

decision, and yet those decisions on 4

individual cases may be the fundamental way that one 5 can drive toward and obtain risk harmonization. 1 6 COMMISSIONER CURTISS: Yes, although I'm 7 not optimistic because what we've seen in the past, as 8 Commissioner Remick has pointed out, is that as we've 9 attempted to resolve issues in the context of 10 individual cases a couple of things have happened. 11

First, our approach has been pretty.

12 disparate. We've been all over the map with the risk 13 assumptions that we have used in various regulatory 14 initiatives within each agency and between the two 15 agencies and one of the central purposes in-16 recommending a risk harmonization section in this MOU 17 was to try to bring some harmony, if you will, to the 18 risk basis upon which we regulate. And I'm not 19 optimistic that going ahead with discrete initiatives 20 is going to lead to a revealed standard, if you will, 21 a rish standard that is going to be harmonious anymore 22 in the future that it has in the past. 23 Secondly, what tends to happen in my view 24 and I guess the low-level waste issue is perhaps an 25 example of this is that the discussion oftentimes NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WASHINGTON D C 20005 (202) 234-4433

69 l 1 ' devolves into is this technologically achievable. Is 2 this something that can be done? What are the 3 differences in terms of what we can achieve from a 4 technical standpoint? And again, maybe that's a way l 5 to regulate based upon what's technologically 6 achievable, but in my view it's not an approach that 7 I would prefer. I'd prefer to see the risk-based P 8 approach that the MOU itself is focused'on trying to 9 achieve. 10 And E,o, as I say, recognizing that the EPA 11 would like to gio forward with the low-level waste 12 initiative and we'd like to go forward with the ACL 13 initiative and resolve those, it strikes me that some.. 14 thought about how we treat those in the context of the 15 Section D provision and treating them harmoniously one i 16 with the other needs to be given. [ 17 MR. BANGART: I just want to

add, i

18 especially on the ACL issue, we have not started the 19 process yet of working above the lowest rung on the 20 ladder to try to resolve that before it gets up to the 21 highest levels of the two agencies, so we likely will 22 be proceeding up that management chain to try to reach 23 some resolution. 24 But my prediction would be that in the ACL 25 issue as the low-level waste standard issue they ) NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (232) 234 4433 WASHINGTON. D C. 20005 (202) 2344433 )

70 1 probably won't get resolved in the kind of timeframe 2 that it's going to take to put the white paper 3 together and reach some conclusions as to where we go 4 with that, so my suspicion is that they'll be captured 5 in the broader effort to reach harmony, although we l 6 are going forward. 7 COMMISSIONER CURTISS: In the case of the 8 ACLs, you do have a Commission-established 10-3 risk l 9 level in the SRM and the risk question has been i 10 addressed already at this level within this agency. { s i 11 MR. BANGART: And we're planning to come 12 back to the Commission with an update'on where we 13 stand on that. 14 MR. AUSTIN: This white paper, and we're 15 talking about in late summer of this year, may be'a 16 far cry from resolution of the issues. It will 17 address. the things that ought to be taken into 18 consideration, but I don't see how it could possibly. 19 resolve the order of magnitude difference between~ the 20 two agencies. That will take a lot of interaction and 21 fundamental considerations within both agencies. 22 COMMISSIONER CURTISS: Yes. 23 I don't have any other questions. I'd 24 again like to commend you for the work that you've put 25 in on this and encourage you to encourage EPA to. keep' L NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W. (202) 234-4433 WASHINGTON, D.C. 20005 (202) 234-4433 i

71 'l up or increase their level of effort so that you can 2 achieve the schedules. They obviously impact on some 3 of the things that are before the Agency right now in 4 specific regulatory contexts. 3 5 I would encourage you as you work in this 6 area to keep active track of what's going on in the 7 risk community more generally and in particular I i 8 guess I would suggest that'we follow the efforts of 9 the risk group that's been est'ablished under the Clean 10 Air Act and that is I think a group of appointees from f 11 various -- the President, the Senate and the House, i' 12 that is working on the broader' risk questions. 13 There is some interesting activity going 14 on right now with legislation in the Senate that would 15 have EPA focus on doing a risk assessment, risk i 16 management evaluation for.each of. their regulatory 17 initiatives, so there's a lot going on in the risk 18 arena as this document obviously points out and as 19 we've seen in other contexts that would be worth 20 keeping close tabs on. 21 But again, I thank you for this effort and 22 commend you for the work that you've done. 23 COMMISSIONER REMICK: I certainly join in i ~ 24 commending the staff both for the document and the 25 presentation and discussion today. It's helped me in l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W (202) 234 4433 WASHINGTON, D.C. 20005 (202) 2344433 )

~ 72 1 understanding the differences or similarities between-2 the two. agencies. 3 And I agree very much with Commissioner f 4 Curtiss on the importance of the ef fort, particularly 5 what follows beyond the white paper, because I think 6 if we can truly work to get some resolution of these 7 differences and a common understanding we'll determine _ 8 whether what we intended when we worked on the'MOU 9 with EPA will actually come to fruition. And I. assume I 10 that's why they wanted an MOU also,.so that hopefully 11 down the road when we're working on issues either 12 where we have common authority or common interest that 13 we'll have an understanding and a method. for 14 proceeding in a mutually acceptable way. 15 So, very important work. I'm glad the EDO 16 is providing the resources that he is on this and I 17 hope it will continue and I thank you very much. 18 COMMISSIONER de PLANQUE: I too am pleased 19 with what you've done so far and cheer you on to 20 continuing and getting EPA to do their share as well. 21 I was particulary interested in the 22 efforts like the comparison charts. I think they're 23 incredibly useful to us, as well as you, I'm sure, and - + 24 I thought it was kind of interesting in the SECY paper 25 one of the things you pointed out was this helped to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON, D C. 20005 (202) 234-4433

73 l' identify some internal inconsistencies and - that's. 2 clearly a step in the right direction. 3 I would also add to Commissioner Curtiss' 4 idea of looking at what's going on in the risk 5 community in general to extending that to the 6 international scene too, because this is really a very 7 active issue. 8 If I have one particular message that I'd r 9 like to deliver, it's one of trying to' stay as neat 10 and clean with the terminology as you can. Often the I 11 problems in this area are ones of semantics more than j ~ 12 real problems. I just not'ced throughout here'that i 13 the same thing was referred to using several different-14 words just in these papers alone, " limit" and'" goal" 15 and " objective," same thing given several different 16 terms, trying to make clear what we're talking about 17 in all of these situations whether it's a goal, a 18 limit, an objective or-whether it's a real standard. - 19 I think it's incredibly important that we 20 try to be consistent in the termino?ogy and try to 21 carry that consistency for ourselves ' but also with 22 EPA. Just using different words can lead to so much 1 23 misunderstanding, so I would encourage you in that-i 24 direction to be very careful and as precise as 25 possible. I know in some cases you're limited by i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234 4433 WASHINGTON, D C. 20005 (202) 234 4433 j

74 1 legislation which 'might ' call something some particular i 2 thing. 3 MR. TAYLOR: That's an important element, 4 particularly in the white paper which will be widely 5 read and distributed. 6 COMMISSIONER de PLANQUE: Right. 7 MR. TAYLOR: Very important. 8 MR. BERNERO: In the white paper. we did on 9 engineering risk assessment that'was a major problem 10 right up front, get the semantics straight. I 11 COMMISSIONER de PLANQUE: Right. 1 12 MR. BERNERO: Because, terminology is so 13 different. 14 COMMISSIONER de PLANQUE: Well you can see l 15 it right in these two papers, different words used for 16 the same - thing, so the more you can do in that [ 17 direction the better. I think you've seen that we've 18 struggled at the Commission level.with terminology 19 used, particularly in the low-level waste area, and 20 sometimes the differences aren't really there but they 21 appear as if they're there. 22 But overall I commend the-staff for what l 23 you've done. It's very good.- Carry on. 24 COMMISSIONER ROGERS: Well, just let me 25 add-my own personal comments in agreement with.my NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. i (202) 2344433 WASHINGTON. D.C 20005 (202) 234 4433

l 75 i 1 fellow Commissioners here. I think that -- I' don't l i 2 have very much to add because I think they real'ly have 3 touched on some of the very important points. 4 I think this question of speaking the same 5 language, not only-not using different words for the 6 same thing, but when you are using the same word that 7 you agree on what it means. That's always not so 8 clear. 9 So I do think that to me this is a very 10 important activity. It's one that I suspect needs to L 11 be supported at the very highest level,

though, 12 because I suspect there will be times when real l

13 frustration will set _in on everybody's part. j 14 I would ask you to keep in mind the 15 possibility at any rate at some time along the way of 4 16 both agencies somehow or.other perhaps maybe taking a 17 little different approach, I mean, rather _ than 18 maybe it's not that we have to agree with them and 19 they have to agree with us, yet there may be a third 1 20 approach here somehow that can emerge from this. I 21 have no idea. 22 I'm just speaking in generalities, but I'm - 23 sure that we both approached these problems on a 24 historical basis. We've built on what we've known 25 over the years. They've done the same thing, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. (202) 234-4433 WASHINGTON, D.C. 20005 (202) 234-4433

76 1 there are times when you know you just are on parallel 2 paths that are not going to come together and it may [ 3 be that there's some way that a quantum step could be i 4 taken.to bring these things together. It might be. i 5 that you're just not going to automatically, even with 6 good will, come together because you're not trying to i 7 achieve things in exactly the same way and maybe 8 there's real value in trying to find a way that is 9 common to both agencies. 10 Certainly the rest of the country I think 11 would like to see a government position and a U.S. i 12 government approach rather than an agency one that a 13 particular corporation, individual, is subject to two 14 conflicting kinds of requirements and there they are. 15 They have to resolve it, whereas we're the ones that 16 ought to be resolving these things for them. 17 So I just would ask you to try and keep in 18 mind the notion that perhaps there might be some way i 19 of breaking through some of these by a little. l 20 different approach. I don't know what it.would be, 21 but sometimes that can help. i 22 I'd like to thank the staff. 23 Particularly, Mike, you did I think an 24 absolutely superb job and I want to just acknowledge 25 that in my opening remarks I really plagiarized very NEAL R. GROSS i COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. l (202} 2344 433 WASHINGTON, D C, 20005 (202) 2344 433 r

77 1 much from what you wrote in the SECY, so I really want - j P 2 to be honest and admit that. l; 3 So, thank you all very much. I think it's 4 been an excellent briefing and we look forward to the l 5-paper, the white paper as soon as it's ready. l 6 (Whereupon, at 3:37 p.m., the above-7 entitled matter was adjourned.) 8 i 9 E 10 11 7 12 13 14 [ 15 16 f 17 18 19 20 21 22 23 f 24 ~ 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.- (202) 2344433 WASHINGTON. D C. 20005 (202) 234 4433 j i

CERTIFICATE OF TRANSCRIBER This is to certify that the attached events of a meeting of the United States Nuclear Regulatory Commission entitled: TITLE OF MEETING: BRIEFING ON STATUS OF EFFORTS FOR RISK HARMONIZATION PLACE OF MEETING: ROCKVILLE, MARYLAND DATE OF MEETING: MAY 26, 1993 were transcribed by me. I further certify that said transcription i is accurate and complete, to the best of my ability, and that the transcript is a true and accurate record of the foregoing events. 1/1A v g-Reporter's name: Peter Lynch t I l 1 1 NEAL R. GROSS COURT Rf90tTERS AND TRANSCttBERS 1323 RM00f ISLAMO AVfWUf. W.W. (202) 5 4 33 W ASMfMOTO N. 0.C. 20005 (202) 232 6 j \\ l

j' United States Nuclear Regulatory Commission i NRC-EPA MEMORANDUM OF UNDERSTANDING: PROGRESS IN RISK HARMONIZATION BRIEFING FOR THE COMMISSION May 26,1993 ,m e mm-we .-og---ei.,rg, -+v e. es..=iWw,-- <w--.+.e.-e =.e cv -,. sow _-+ .-v-, w.. -es, e-6. e,m. mm.- .,su m,mm__m____._m.m. ..u. m..2. .m ..m m

p'"% United States \\,,,,f}1 Nuclear Regulatory Commission NRC-EPA Memorandum of Understanding Signed by the EPA Administrator and the Chairman on March 16, 1992 e Basic framework for resolving interface issues related to the regulation of radionuclides in the environment e Directive to explore risk harmonization l L^ 1 May 26,1993 i. l-

p"% United States \\,,,,)1 Nuclear Regulatory Commission Need for Risk Harmonization e Five priority-issues Clean Air Act regulation of radionuclides EPA low-level radioactive waste standards Groundwater protection standards for uranium mill tailings Radiological criteria for decommissioning . EPA high-level waste standards Exploration of risk harmonization is essential for resolution of the e priority issues 2 . May 26,1993 ~ - -.. -.. . _ a. _. _. _. _....., -... _. _ -.... ... a..

.r* p. (,o United States %,,,,,,/ Nuclear Regulatory Commission Risk Harmonization Components e Risk Assessment Methods, assumptions, and other considerations involved in quantifying or estimating health risk e Risk Management Selection of risk goals and associated measures to achieve the goals e Agency-specific risk management approaches appear to be source of both real and. perceived differences between NRC and EPA 3 May 26,1993 -...-,,-u- ..__.-,i....mm m-m- - --.--mm m a s -__ ____. _. _.,_me._ 4 ..m. m

Risk Harmonization 10.2 A _imit i 4% -3 t 10 t t t l t t t -4 R 10 t t t -6 l 10 t t s Goa / Limit -e ,o Lifetime EPA NRC g;gg Bottom Up Top Down l 4

p.- ~s t United States \\,,,,,,) Nuclear Regulatory Commission RISK ASSESSMENT COMPARISON Scope NRC Programs EPA Programs l - Decommissioning - High-level waste f - Low-level waste - Low-level waste l - High-level waste - Uranium mill tailings - Uranium Recovery - Indoor radon - Materials licensing - Superfund - Fuel cycle facility licensing - Hazardous and solid waste - Radiation protection standards. management - Eftluent requirements for - Clean Air Act reactor facilities - Safe Drinking Water Act l - Clean Water Act' l 5 May 26,1993

d e'"Ng l } United States \\,,,,,,/ Nuclear Regulatory Commission Risk Assessment Comparison

• Similarities in Risk Assessment Approaches (November 1992)

Both agencies generally use deterministic risk assessments Both agencies. generally assess exposure to reasonable maximally exposed individual and usually consider the same exposure pathways Both agencies translate exposures and intakes into doses and risks using internationally accepted techniques Both agencies assess risk primarily in terms of cancer fatalities Both agencies sometimes. truncate risk assessments -6 'May 26,1993 '

s p*~% y United States a s,,,,,,/ Nuclear Regulatory Commission Risk Assessment Comparison e Differences in Risk Assessment Approaches (November 1992) - Use of site specific vs. generic assessments - Use of slightly.differentLrisk coefficients for conversion - Assumption of different long-term exposure scenarios NRC Risk Assessments EPA Risk Assessments 1 - Limit on' individual risk - Limit on population risk .- Use of radiological dose in - Use of health risk .rulemaking and compliance assessment - Truncation of population dose - No truncation of population dose in terms of time and space-- if it affects control options 7 -- May 26,1993 -m.s.- .m.mm.~,-i e... ..-..--,--cs 4.* ,--w e.,.- - - ~ee.-w .- ~..,, - - - - *.. - - -,, or w-. ~w -e-*

e 9 f - %,, .1 United States \\,,,,,) Nuclear Regulatory Commission Risk Management Comparison e Comparison is currently in process Risk Management Attributes e Dose and risk limitation Basis for limitation Implementation considerations Compliance' mechanisms -. Exceptions e Range of NRC and EPA programs consistent with Risk Assessment Comparison 8 May 26,1993 m . _.. _.. ~. _........,,. ~. . x .2 =

p-~% (, %,,,,,)y United States. Nuclear Regulatory Commission RISK HARMONIZATION l WHITE PAPER e Results of Risk Assessment-and Risk Management comparisons Foundation for. risk harmonization process Consistent basis for future efforts e Specific Highlights New opportunities Issues deserving additional attention Priority issues for discussion - Draft complete in late Summer 1993 9 May 26,1993 4 ...--.-.----.--..-,..._.__x,-----_-.1._-

p-~ % (, <,,} United States %,,,,,) Nuclear Regulatory Commission Future for NRC-EPA Risk Harmonization e More similarities in risk assessment than differences Risk management differences appear to be more significant e e Stated risk objectives differ e Level of protection is clouded by differences in regulatory approach - Defense in depth ALARA measures - l Level of review - -Inspection and enforcement l l e Risk-management comparison and White Paper will attempt to i address these factors 10 May 26, IM3 -.-.....-.-.....-.-...:...-. -. -... =.. -.... - -- -. -~. .=..~...~.. - - . - -}}