ML20140D849
| ML20140D849 | |
| Person / Time | |
|---|---|
| Issue date: | 04/22/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20140D854 | List: |
| References | |
| COMSECY-96-061, COMSECY-96-61, DSI-12, NUDOCS 9704240161 | |
| Download: ML20140D849 (11) | |
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-l April 22, 1997 l
1 SECY NOTE:
The following documents are being released to the public at this time:
i 1.
Text of DSI 12 (Risk-Informed, Performance-Based Regulation) 2.
Staff Requirements Memorandum dated April 15, 1997.
3.
Views of Chairman Jackson dated February 3, 1997.
4.
Views of Commissioner Rogers dated January 23, 1997.
5.
Views of Commissioner Dicus dated January 28, 1997.
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6.
Views of Commissioner Diaz dated January 28, 1997, i
7.
Views of Commissioner McGaffigan dated February 13, 1997.
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8.
Memorandum from Commissioner Dicus dated March 27, 1997.
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John C. Hoyle I
Secretary of the Commission 4
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Risk-informed, Performance Based Regulation
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Sanmary A-2beit of C =s i
l 3.9 RISK-INFORMED, PERFORMANCE-BASED REGULATION (DSI 12)
COMS ECJ-9,6--Q6J,,
3.9.1 The Direction-Setting Issue and the Options cx.
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What criteria should NRC use in expanding the scope in applying a risk-informed, performance-based approach to rulemaking, licensing, 5.i I
inspection, and enforcement?
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a Option 1:
Continue Current Process a
e UJ Option 2:
More Rigorously Assess Relationship to Public Health and Safety * $! N j
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Perform a Comprehensive Assessment of NRC Regulatory Approaches Option 3:
. cz-1 Option 4:
Consider Risk-Informed, Performance-Based Approaches Primarily in Response to Stakeholder Initiatives l.......
3.9.2 Commission's Preliminary Views The Commission recognizes that, in order to accomplish the principal mission of the NRC in an efficient and cost-effective manner, it will in the future have to focus on those regulatory activities that pose the greatest risk to This can be accomplished by building upon probabilistic risk the public.
assessment concepts, where applicable, or other approaches that would allow a In risk-graded approach for determining high-and low-risk activities.
general, those activities that are of a higher risk should be the primary focus of the agency's efforts and resources. The level of staff activity u
associated with-lower risk activities should be determined based on a consideration of the cumulative impacts on safety, stakeholder initiatives and burden; reduction, and'the'effect'on agency and licensee efficiency.
The stNf should continue with the current efforts, in cooperation with the industry (Option 1), including pilot programs. The objective of this initiative is to obtain additional information regarding the appropriateness of a risk-informed,, performance-based' approach for the subject activities.
These activities and their schedule are presently captured in the agency's PRA Implementation Plan. As data from performance-monitoring of structures, systems 'and components are accumulated, the staff should evaluate the perfomance data to determine the effectiveness of the approach on the subject activity.
The staff should proceed in the direction of enhancing the PRA Implementation Plan (i.e., moving'toward implementation of elements of Option 3) by building t
on the Regulatory Review Group's (RRG) results, which were initially focused on reducing the regulatory burden, with.a more focused assessment of those regulations that are amenable to a risk-informed, performance-based approach.
In determining'the priority and scope of regulatory activities to be included i
in moving in the direction of partial implementation of Option 3, the staff should consider the cumulative impacts on safety, stakeholder initiatives and This burden reduction, and the effect on NRC and licensee efficiency.
approach should result in a further focusing of resources, on the various areas that the Commission regulates, that is commensurate with its risk si,gnificance, potential burden reduction and effect on efficiency.
Page 3,85 Phnw fl Stakholder interaction Report
a The staff should evaluate and clarify any technical and/or administrative issues associated with performance-based approaches to regulation (e.g.,
inspection activities, enforcement, etc.). The staff should also perform a i
thorough review of the basis for nuclear materials regulations and process and should identify and prioritize those areas that are either now amenable, or can be made amenable with minimal additional effort and resources to a risk-informed, performance-based approach. This assessment should eventually lead to the development of a framework for applying PRA to nuclear material uses that is similar to the one developed for reactor regulation (SECY-95-280), where appropriate.
In the public comments on this issue, the NRC particularly solicited views on how it should deal with dual regulation when applying a risk-informed, performance-based regulatory philosophy.
3.9.3 Summary of Comments A.
Significant/Important Comments Directly Affecting the Preliminary Views or the Direction-Setting Issue Almost all the commenters supported the Commission's view that, in general, those activities that are of a higher risk should be the primary focus of the agency's efforts and resources. Consequently, most commenters supported the movement toward more risk-informed, performance-based regulatory approaches.
Several commenters (including the Advisory Committee on the Medical Uses of Isotopes and commenters at the public meetings) suggested that the paper was difficult to understand. Although commenters supported the Commission's precept to focus on those activities that are of higher risk, most commenters either provided qualified support for the combination of options selected by the Commission in its preliminary view or supported combinations of the optionsthatwere'differentfromtheCommission'spreliminaryview.
For example, the Organization of Agreement States (OAS) and the Conference of Radiation Control Program Directors (CpCPD) supported a combin'ation of all the options. The Nuclear Energy Institute (NEI) generally concurred with the Commission's preliminary views but emphasized what it considered to be several important implementation-issues including the need to consider changes to 4
regulations without necessarily requiring an improvement in safety.
NEI indicated that the implementation of a risk-informed, performance-based regulatory concept, framework, and practices should build on those established through the Maintenance Rule (10 CFR 50.65) and that there is no need for 7
further protracted debate.
0AS' comments for DSI 12 were endorsed by the States of South Carolina, 1
Mississippi, Georgia, Utah, t.ouisiana and New Hampshire. CRCPD and the State of Texas did not explicitly endorse OAS' comments but enclosed comments that were almost identical to those provided by the OAS.
NEI's comments were endorsed by Westinghouse, South Carolina Electric 2
and Gas Company, and Entergy Operations.
Yankee Atomic Electric Company references NEl's responses and indicates support for NEI's comments on DSI 12.
Siemens Power Corporation stated that they were in general agreement with-j NEI's comments.
Phase 11 Stakeholder interacion Report Page 3-86
Rbk Informed, Performance-Based Replation SumrNzry Analysh of Comments Public Citizen supported Option 2, that is, to more rigorously assess relationship of proposed risk-informed, performance-based activities to public The Environmental Coalition on Nuclear Power (ECNP) did health and safety.
not favor risk-informed, performance-based regulation indicating that risk-informed, performance-based regulation will result in deregulation and relaxation of requirements.
Some commenters, including the State of Washington, supported a stakeholder-driven process. The State of Washington stated that by allowing industry and stakeholders to drive the application of probabilistic risk assessment (PRA),
the NRC may save staff time by applying resources only to those areas identified as significant and further suggested that the potential downside of
" ramping up to speed" could be minimized by collectively agreeing on a 3-5 year plan of areas for emphasis.
One comenter (Maloney) noted that PRA estimates are based on the assumption that a plant completely conforms to design and license standards, and, given recent concerns at some plants, the relevance of PRA for policy decisions seems even farther from the practical decisions of NRC inspectors and plant The commenter suggested that the NRC abandon continued attempts to incorporate PRA into the regulatory process because PRA continues to fall managers.
validation, short on the most fundamental issues of any mathematical model:
reproducibility, precision and continuity, and measuring the experience of Finally, the commenter suggested that the agency and the industry change.
might benefit from a study of how competitive industries deal with comparable issues of performance and reliability management.
After reviewing the comments, four general areas were identified that may affect the Commission's preliminary view.
Recognizing the dist.inction and defining the relationship between " risk-1.
informed" and " performance-based."
Some commenters noted distinctions between " risk-informed" and " performance-based" and used the distinctions to support comments for moving more cautiously toward the performance-based aspects of risk-informed, performance-based regulation. For example, in the OAS response to Direction-Setting Issue (DSI) 11, the OAS indicated that the NRC 'should aggressively pursue the move However, performance-based regulation is toward risk-focused inspections.
good for the licensees that have a good attitude and safety culture, and it wil.1 not work for those weaker licensees. Similarly, the State of Maryland cautioned that prescriptive regulatiun is good in that it has had a larger base of review against potential hazards and provides an increased attention to detail that may be lacking with performance-based regulation.
Regulation should continue to reflect conservatism well below what a risk-based evaluation would allow.
'The NRC Director for the Office of Enforcement (OE) expressed concern about the current agency emphasis on risk-informed, performance-based regulatory approaches and states that NRC should be focusing on the fund programmatic issues.
The Director of and not achieve success fortuitously by relying on margins.
OE further indicated that NRC needs to focus not only on the results, but also on the process, procedures, training, the degree of questioning attitude, self
, assessments, and so on, so that the agency can identify programmatic issues before negative results affect the public.
Page 3-87 Phase 11 Stakeholder Interaction Report
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Other commenters asserted that more emphasis needs to :e placed on the
" performance-based aspect of risk-informed, perfonrance-based regulation.
One commenter (Performance lechnology) suggested that the NRC immediately start at least two pilot programs ts dwor.strete the 5 fficiency of a risk-informed, performance-based decisior proccu.
The Council on Radionuclides and RadiophumaceMt&! and Hallinckrodt Medical visi:" and the type of regulat. ion suggested that the relationsMp between needs further consideration.
That is, highn risk activities should not necessarily call for more prescriptive regulations and that the NRC will need to make a more sophisticated analysis when determining the appropriate j
regulatory basis for practices involving high hazards.
Finally, an NRC staff member suggested that because of the lack of a framework j
for performance-based regulation, a new policy statement that includes all aspects of risk-informed, performance-based regulation should be issued by the 4
Comission to provide guidance to the staff and the industry and to ensure an 4
efficient transition.
Demonstrating a commitment to change the regulatory environment and 2.
establishing a new strategic direction.
Several commenters (as discussed below) expressed concern about the agency's commitment to change the regulatory environment and to establish a new strategic direction. Some commenters emphasized that a new regulatory process will mean changes to NRC and industry assessment practices and culture, expressed skepticism that the agency is genuinely receptive to changing its longstanding regulatory approaches, or indicated that the direction-setting issue was not really a direction-setting issue.
1 The Oregon Office of Energy indicated that before choosing any of the options, Further if the NRC must break a stalemate that has surrounded the use of PRA.
7 PRA is to be useful, the NRC and the industry must reach an agreement on what In a stakeholder public meeting, an NEI representative PRA will be used for.
indicated that no matter what option is implemented, the industry is concerned that risk-informed, performance-based regulation does not become an additional In addition, according to the NEI representative, if the layer.of regulation.
industry and NRC continue with everything they are doing today instead of 4
focusing on results, establishing performance criteria, and being able to show i
i quantitatively that they have effective programs, a major step back will have Yankee Atomic Electric Company (YAEC) notes that the vagueness of been"taken.
the Commission's preliminary views does not bode well for achievement of significant progress in this area in the ft.ture.
Several commenters (associated with nuclear material users) indicated that current level of interest and current efforts in pursuing more risk-informed, performance-based regulation in nuclear materials areas were not accurately According to some commenters, in this respect, characterized in the paper.
the Commission's preliminary views do not respond to the current environment 3
and challenge of material licensees (i.e., the urgency to systematically review regulations to develop cost-effective, risk-informed, performance-based regulations).
The State of Two commenters suggested that the DSI should be redefined.
Tennessee suggested a high-level strategic direction in which the NRC should establish a program to regulate all radioactive material at any concentration Phase 11 Stakeholder interaaion Report Page.%88
Risk informed. Perforrnance-Beed Regulation Suminary Analysis of Comments which presents a risk beyond that presented by the natural concentrations of material found in the earth. Entergy Operations stated that the description of the risk-informed, performance-based strategic issue did not appear to meet the intent of the rebaselining initiative.
It did not appear that the staff revisited basic philosophy and principles.
Rather, it summarized a set of options for how quickly the NRC should proceed with the use of risk-informed, performance-based regulation.
According to Entergy, two issues that should have been considered are (1) establishing a regulatory threshold and (2) the adverse effect of regulation on safety. The Commission's preliminary view only seeks to preserve the status quo and avoids dealing with real risk-informed, performance-based rebaselining issues.
3.
Fostering public confidence and ensuring public understanding of the process.
Several commenters (including commenters at the stakeholder public meetings) emphasized the importance of ensuring that information associated with risk-informed, performance-based regulation is effectively communicated to the public. The OAS suggested that risk should be explained in a form that the public can easily understood and the transition toward risk-informed, performance-based regulation should be accompanied by an aggressive public education program. The State of Oregon suggested that a transition toward risk-informed, performance-based regulation will likely be accompanied by a perceived decrease in public perception of NRC credibility because of
" relaxation" in current requirements. The Advisory Committee on the Medical Uses of Isotopes and other commenters suggested that the DSI paper cannot be easily understood by the general public and the public will not understand the implications of proceeding toward risk-informed, performance-based regulations.
Public Citizen stated that safety has already been, and will continue to be, sacrificed as the NRC shifts its regulatory philosophy.
So long as the nuclear industsy views risk-informed, performance-based regulation as synonymous with non-enforcement, any move toward accelerating the transition will likely result in reducing the margin of safety at operating reactors The impression is that the NRC has been deregulating across the country.
safety requirements on the basis of how burdensome the regulation was to the licensee.
Establishing an objective standard for adequate protection of the public 4.
health and safety.
Several comments concerning the application of risk-informed, performance-based regulation for power reactors and several comments concerning the application of risk-informed, performance-based regulation for nuclear material conveyed concerns about the development of objective standards for risk-informed, performance-based regulation.
In general, those comments concerning objective standards for power reactors emphasized the need to develop a " regulatory threshold" or objective standard for the adequate protection of public health and safety.
An NEI representative commented that it is extremely important that we start using YAEC indicated that there was no meaningful discussion of the Safety Goals.
any projected activities directed toward establishing a comprehensible nexus between the Safety Goals articulated 13 years ago by the Commission and an objective standard to assess the adequacy of the existing regulation and the Page 3-89 Phme 11 Stakeholder Interaction Report
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need, if any, for additional regulations.
Entergy Corporation stated that if the Safety Goals set a sufficient level for public health and safety, then they should be formalized through regulation with appropriate implementation guidance.
Entergy ' indicated that rational use of the Safety Goals within the regulatory framework is the ultimate marriage of risk-informed and performance-based regulation.
Framatome Technologies emphasized that the use of nuclear energy clearly involves risks, but putting those risks into context with other societal risks is of fundamental, strategic importaoce.
In the nuclear materials area, where there are no Commission-approved Safety Goals, some commenters suggested the need for an independent agency to establish standards, the need for these standards to be performance-based, and the need for these standards to be adopted by appropriate regulatory agencies.
The Non-Destructive Testing Management Association (NOTMA) stated that it is imperative that the NRC define objective safety goals for the radiography industry.
NDTMA further stated that it is not possible to evaluate the cost efficiency of a proposed rule, nor perform a periodic review of the effectiveness of a rule, without measurable safety goals.
B.
Comments on Other Options As stated in 3.9.3. A, although commenters supported the Commission's precept to focus on those activities that are of higher risk, most commenters either provided qualified support for the combination of options selected by the Commission in its preliminary view or supported combinations of the options that were different from the Commission's preliminary view.
In general, comments associated with Options 2 and 4 either strongly supported the particular option or strongiy opposed the particular option. The State of Michigan's comments epitomize some commenters view concerning the options and their relationship to the NRC's mission. Michigan stated that Option 2 appears to most supportable, especially if scoping criteria are refined to guide NRC resources, and that Option 4 appears to depart from what Michigan believes should be a primary mission of the NRC.
As previously di." 'ssed, the OAS indicated that aspects of all options should
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be adopted. Undm 'ts discussion of Option 2, the OAS stated that rigorous PRAs should be rt.3 of power plant licensees so that they can be relied upon as satisfactory tools for regulatory applications. The OAS and the State of Illinois believed that plant-specific risk analyses should be required, should meet standards for accuracy and completeness, and should be kept current.
C.
Comments on Important Omissions Several comenters (including NEI, OAS, and others) provided detailed information concerning omissions from the paper.
In summary, commenters suggested that the following should have been. considered in the development of the DSI paper and/or the Commission's preliminary view.
1.
A more comprehensive assessment and discussion of the necessary level of training and experience that may be necessary to implement risk-informed, performance-based regulation including an assessment of how the level of staffing and level of staff expertise may affect how fast and how far the agency and industry proceed toward risk-informed, performance-based regulation.
Phase 11 Stakeholder Interaction Repon Page k-90
S:=-Ary Analvsi. cf Comments Risk informed, Performance-Based Regulation 2.
The effect of the transition toward risk-informed, performance-based i
regulatory approaches on continued cooperative efforts in materials programs such as parallel rulemaking process with the Agreement States.
3.
A more detailed discussion of how risk-informed, performance-based approaches will be implemented, that is, th9 need to consider when risk-informed, performance-based regulation should be mandatory or optional.
D.
Comments on Internal / External f actors YAEC. indicated that the discussion of factors is general and that it is difficult to offer substantive comments.
Some of the factors discussed, such as " risk harmonization" have been given greater value than is warranted by actual results.
Further YAEC believes that the NRC should accept the 3
challenge of demonstrating results and clear benefits commensurate with the resources expended on initiatives such as the risk harmonization effort.
The NEI. indicated that NRC's role as a leader in risk-informed, performance-1 based regulation, both domestically and internationally, should be considered a significant influencing factor.
In addition, NEI suggested that the onset
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of electrical power deregulation should be reflected as an external factor.
E.
Comments on Staff Requirements Memorandum Question.
l The Commission solicited comments on how NRC should. deal with dual regulation when applying a risk-informed, performance-based regulatory philosophy.
In the nuclear materials area, some commenters suggested the need for an
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independent agency to establish standards and the need for these standards to Furthermore, some commenters suggested, once these be performance-based.
standards were established, the adverse effects of dual regulation may be minimized.
Other commenters indicated that the way to resolve dual regulation is to
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change the statutory authority to eliminate the dual regulation or to apply the concept of risk-informed, performance-based regulation across regulatory agency boundaries. Some commenters encouraged the use of NRC resources to m ek a common risk philosophy among regulating agencies.
NEI suggested that
/nere there is dual regulatory jurisdiction on matters associated with radiological hazards and materials, it is essential for the NRC to be the lead According to NEl, a common interagency regulatory framework is agency.
central to improving the effectiveness and efficiency of.the nuclear regulatory process.
One commenter, the ECNP, supported continued dual regulation and viewed dual regulation as an extension of redundancy of safeguards.
3.9.4 List of Commenters i
WRITTEN COMMENTS 1.
September 24, 1996, Stephen Maloney, Devonrue t.TD 2.
October 21, 1996, Organization of Agreement States (Robert Quillin) i Page 3 91 Phase 11 Stakeholder Interaction Report
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3.
October 23, 1996, Summary of Discussion at Agreement State / NRC Regulators' Meeting 4.
October 28, 1996, State of Washington (Terry Frazee) 5.
October 29, 1996, James Lieberman, U.S. NRC 6.
October 29, 1996, Richard Barkley, U.S. NRC 7.
October 30, 1996, Barry Mendelsohn, U.S. NRC 8.
November 3, 1996, Marvin Lewis 9.
November 4,1996, State of New Hampshire (Diane E. Tefft) 10.
November S, 1996, State of Michigan (Flint C. Watt) 11.
November 7,1996, State of Mississippi (Robert W. Goff) 12.
November 8,1996, State of Tennessee (Michael H. Mobley) 13.
November 12, 1996, Glenn Kelly, U.S. NRC 14.
November 13, 1996, State of Oregon (David Stewart-Smith) -
15.
November 13, 1996, Glenn Kelly, U.S. NRC 16.
November 13, 1996, Performance Technology (Bob Christie) 17.
November 14, 1996, League of Women Voters of Rockford, IL (Betty Johnson) 18.
November 14, 1996, State of Oregon (Ray D. Paris) 19.
November 14, 1996, State of South Carolina (M. K. Batavia) 20.
November 20, 1996, Dr. Moni Dey, U.S. NRC 21.
November 20, 1996, U.S. Department of Energy, Office of Civilian Radioactive Waste Management (Daniel E. Dreyfus) 22.
November 21, 1996, State of Louia.iana (Penald Wascom) 23.
November 21; 1996, State of Georgia (Thomas E. Hill) 24.
November 21, 1996, State of Utah (William J. Sinclair) 25.
November 22, 1996, South Carolina Electric & Gas Company (Gary J.
Taylor) 26.
November 24, 1996, N. P. Kad ebi, U.S. NRC 27.
November 25, 1996, Westinghouse Electric. corporation (N. J. Liparulo) 28.
November 25, 1996, Framatome Technologies (John R. Bohart)
Page 3-92 Phase 11 Stakeholder interaaion Report
- Rhk-informed. Perfonnance-Based Regulation Summary Analysk of Comments 1
29.
November 26, 1996, Advisory Committee on the Medical Uses of Isotopes (Judith Anne Stitt, M.D.)
30.
November 27, 1996, Nuclear Energy Institute (Dr. Thomas D. Ryan) 31.
November 27, 1996, State of Texas (Richard A. Ratliff) 32.
November 27, 1996, Conference of Radiation Control Program Directors, Inc.
(William P. Dornsife) 33.
November 27, 1996, Council on Radionuclides and Radiopharmaceuticals, Inc. (Roy W. Brown) 34.
December 1,1996,- Environmental Coalition on Nuclear Power (Judith H.
Johnsrud) 35.
December 2,1996, State of New Jersey (Jill Lipoti) 1 36.
December 2, 1996, Yankee Atomic Electric Company (Jane M. Grant) 37.
December 2,1996, State of Maryland (Roland G. Fletcher) 38.
December 2, 1996, Entergy Operations, Inc. (Michael J. Meisner) 39.
December 2,1996, Mallinckrodt Medical (Ashok Dhar) 40.
December 2,1996, ABB. Combustion Engineering Nuclear Systems (Charles B.
Brinkman) 41.
December 2,1996, Nuclear Waste Division, Clark County, Nevada (Dennis Bechtel) 42.
December 2,1996, National Mining Association (Richard L. Lawson) 43.
December 2, 1996, Non-Destructive Testing Management Association (R. D.
Dicharry) 44.
December 2, 1996, State of Illinois (Thomas W. Ortciger) 45.
December 3,1996, Public Citizen's Critical Mass Energy Project (James i
Riccio) 46.
December 3, 1996, Siemens Power Corporation (L. J. Maas)-
47.
December 4, 1996, State of Pennsylvania (William P. Dornsife) 48.
December 5, 1996, Morton Associates (Henry M. Morton) j 49.
December 6, 1996, James Creed, U.S. NRC ORAL COMMENTS f
Washington, D.C. (October 24 - 25, 1996) pages 93 - 127 1.
Clayton Hinnant, Carolina Power and Light Page 3-93 Phme 11 Stakeholder interaction Report
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Jim Riccio, Public Citizen' Critical Mass Energy Project i
3.
Tony Thompson, National Mining Association 4.
Henry Morton l
S.
Ruth McBurney, CRCPD 6.
Lynn Fairobent, ATL International, Inc.
7.
Greg Gurican, GPU Nuclear, Inc.
i 8.
Tom Hill, OAS 9.
Janice Stevens Colorado Springs, CO (October 31 - November 1,1996) pages 341 - 369 1.
Steve Floyd, NEl-2.
Thomas Tipton, NE!
3.
Roger Huston, NE!
4.
Roger Walker, Texas Utilities Electric Co.
5.
Ashok Dhar, Mallinckrodt Medical 6.
Bill Sinclair, OAS 1
7.
Ken Weaver, CRCPD 8.
Les England, Entergy Operations j
Chicago, IL (November 7 - 8, 1996) pages 90 - 125 1.
Roy White, Illinois Department of Nuclear Safety (IDNS) 2.
Steve Collins, OAS 3.
Mark Doruff, Amersham Corporation j
i 4.
Kristen Erickson, Michigan State University 1
5.
Betty Johnson, League of Women Voters of Rockford, IL l
6.
Glenn Kelly, US NRC Page 3-94 Phase 11 Stakeholder Interaction Report l