THE CENTER FOR NUCLEAR WASTE REGULATORY 

ANALYSES (CNWRA®

) PERSPECTIVE ON 

PRELICENSING INTERACTIONS AND 

INFORMATION GATHERING 

Prepared for 

U.S. Nuclear Regulatory Commission 

Contract NRC–02–07–006 

Prepared by 

Budhi Sagar 

John Stamatakos 

Amitava Ghosh 

Center for Nuclear Waste Regulatory Analyses 

San Antonio, Texas 

September 2011 
ii 

ABSTRACT 

Through the Nuclear Waste Policy Act of 1982 (NWPA) and the Nuclear Waste Policy 

Amendment Act of 1987, Congress directed the U.S. Department of Energy (DOE) to engage 

the U.S. Nuclear Regulatory Commission (NRC) in prelicensing consultations regarding 

activities at the proposed Yucca Mountain high-level radioactive waste repository in Nevada to 

facilitate identification and early resolution of complex technical issues. The NRC was assisted 

by the Center for Nuclear Waste Regulatory Analyses (CNWRA®) in these prelicensing 

interactions. Based on the set of mutually agreeable guidelines, developed by the DOE Office 

of Civilian Radioactive Waste Management and the NRC Office of Nuclear Material Safety and 

Safeguards (NRC, 1999), the prelicensing interactions were of the following types: Appendix 7 

meetings, management meetings, and technical exchanges. In addition, project staff from DOE 

and NRC would interact biweekly for status updates. Furthermore, the NRC and CNWRA staff 

members visited the Yucca Mountain site, participated in observing DOE quality assurance 

audits, and conducted several public outreach meetings. CNWRA perspectives regarding these 

prelicensing interactions are discussed in this report together with suggestions for potential 

improvements for implementation of similar processes in the future. 

REFERENCE 

NRC. “Agreement Between U.S. Department of Energy/Office of Civilian Radioactive Waste 

Management and U.S. Nuclear Regulatory Commission/Office of Nuclear Material Safety and 

Safeguards Regarding Prelicensing Interactions.” SECY–99–031. Washington, DC: 

NRC. 1999. 
iii 

CONTENTS 

Section Page 

ABSTRACT ................................................................................................................................... ii 

TABLE .......................................................................................................................................... iv 

ACKNOWLEDGMENTS ................................................................................................................. 

1 INTRODUCTION ................................................................................................................ 1-1

2 BACKGROUND ON SITE CHARACTERIZATION PROGRAM .......................................... 2-1

3 TYPES OF NRC-DOE PRELICENSING INTERACTIONS ................................................. 3-1

4 CNWRA PERSPECTIVES ON EFFECTIVENESS OF INTERACTIONS ........................... 4-1

4.1 Appendix 7 Meetings ................................................................................................. 4-1

4.2 Technical Exchanges ................................................................................................ 4-2

4.3 Site Visits ................................................................................................................... 4-4

4.4 NRC-DOE Management Meetings ............................................................................ 4-5

4.5 Observations of DOE Quality Assurance Audits ....................................................... 4-5

4.6 Biweekly Yucca Mountain Status Meetings ............................................................... 4-6

4.7 Visits to the DOE Licensing Support Office ............................................................... 4-6

4.8 Public Outreach Meetings ......................................................................................... 4-6

5 SUMMARY .......................................................................................................................... 5-1

6 REFERENCES ................................................................................................................... 6-1

ATTACHMENT⎯SECY–99–031 
iv 

TABLE 

Table Page 

3-1 Types of NRC and DOE Prelicensing Interactions and Their Characteristics ................ 3-4 
v 

ACKNOWLEDGMENTS 

This report describes work performed by the Center for Nuclear Waste Regulatory Analyses 

(CNWRA®) for the U.S. Nuclear Regulatory Commission (NRC) under Contract No. 

NRC–02–07–006. The activities reported here were performed on behalf of the NRC Office of 

Nuclear Material Safety and Safeguards, Division of High-Level Waste Repository Safety. This 

report is an independent product of CNWRA and does not necessarily reflect the view or 

regulatory position of NRC. 

The author gratefully acknowledges J. Winterle for his technical review, W. Patrick for his 

programmatic review D. Pickett for his concurrence review, and editorial review, and A. Ramos 

for his administrative support. Authors were also benefitted significantly from discussion with 

many CNWRA staff members. Their contribution to this document is gratefully acknowledged. 

QUALITY OF DATA, ANALYSES, AND CODE DEVELOPMENT 

DATA: No CNWRA-generated original are contained in this report. Sources of other data 

should be consulted for determining the level of quality of those data. 

ANALYSES AND CODES: No CNWRA-generated codes runs or results are included in this 

report. Other sources of analyses and codes are described and the referenced sources should 

be consulted for determining the level of quality of those analyses and codes. 
1-1 

1 INTRODUCTION 

Through the Nuclear Waste Policy Act of 1982 (NWPA) and the Nuclear Waste Policy 

Amendment Act of 1987, Congress directed the U.S. Department of Energy (DOE) to engage 

the U.S. Nuclear Regulatory Commission (NRC) in prelicensing consultations regarding 

activities at the proposed Yucca Mountain high-level radioactive waste repository in Nevada. 

The primary objective of these NRC-DOE prelicensing consultations was to facilitate 

identification and early resolution of complex technical issues via discussions between technical 

and management staff of the two agencies. It was expected that these early discussions would 

help in developing a high quality and substantially complete license application for constructing 

and operating a geologic repository for high-level radioactive waste that could be reviewed and 

litigated in the limited period of 3 years, as mandated in the NWPA. 

Before DOE submitted its license application on June 3, 2008, NRC had the following 

prelicensing responsibilities: 

• Review the DOE Site Characterization Process 

⎯ Review the DOE Quality Assurance (QA) Program 

⎯ Resolve Key Technical Issues related to the high-level nuclear waste disposal 

• Establish the high-level nuclear waste disposal regulations (e.g., 10 CFR Part 63) 

• Review the DOE Site Recommendation 

• Review the DOE Environmental Impact Statement for Yucca Mountain 

• Develop guidance and licensing bases (e.g., Yucca Mountain Review Plan) 

• Establish communications with stakeholders and DOE (e.g., public meetings and 

prelicensing interactions) 

Throughout the prelicensing activities related to the proposed radioactive waste repository, 

NRC was assisted by the Center for Nuclear Waste Regulatory Analyses (CNWRA®). 

CNWRA was established in 1987 as a Federally Funded Research and Development 

Center, sponsored by NRC, to assist in resolving technical and regulatory issues related 

to the potential geologic repository. 

In the rest of this document, CNWRA perspectives regarding these prelicensing interactions are 

discussed together with suggestions for potential improvements for implementation of similar 

processes in the future.
2-1 

2 BACKGROUND ON SITE CHARACTERIZATION PROGRAM 

The site characterization activities at the Yucca Mountain site began in earnest in 1988 when 

DOE published its Site Characterization Plan. The plan envisioned many scientific and 

engineering investigations to determine the site’s waste isolation capabilities. During the course 

of investigations, the originally envisioned activities were modified, deleted, or supplemented, as 

needed. Surface based characterization activities, such as excavation of test pits and trenches 

and drilling of boreholes started in 1991 when the State of Nevada granted DOE the required 

permits. In 1994, DOE started to excavate the Exploratory Studies Facility (ESF) using a tunnel 

boring machine. The ESF consisted of a 7.5 m [25 ft] diameter and approximately 8 km [5 mi] 

long tunnel. It was designed as an area where underground in-situ experiments could be 

performed. Within the ESF, there were seven test alcoves and four test niches that were used 

to investigate hydrologic, hydro-chemical, and thermo-mechanical properties of the rock units at 

the Yucca Mountain site. The ESF also was used to map various geologic features, such as 

faults and fractures. To gather additional data regarding the rock characteristics at the 

repository horizon, DOE began excavating a smaller exploratory tunnel {5.5 m [18 ft] diameter 

and 3.2 km [2 mi]} across the main tunnel in 1997. This second tunnel was referred to as the 

“Cross Drift,” and was formally part of the Enhanced Characterization of the Repository Block 

(ECRB) study. The main purposes of the Cross Drift were to allow DOE to examine specific 

volcanic strata not intersected by the ESF and to characterize the Solitario Canyon fault in 

the subsurface. 

In addition, DOE drilled more than 450 deep and shallow boreholes to collect more than 

23,000 m [75,000 ft] of core samples and 18,000 geologic and water samples. Additionally, 

DOE studied quaternary fault displacement in more than 60 trenches and several 

natural exposures. 

The primary NRC objective of interactions during the site characterization phase of the project 

was to identify early any factors that may affect repository licensing. Towards that end, NRC 

and CNWRA staff members observed DOE site characterization activities, including excavation 

of the ESF and ECRB crossdrift. 

To manage the interactions in a transparent manner, the NRC developed a framework of key 

technical issues (KTIs). There were ten KTIs covering general areas of study related to the 

postclosure performance assessment (e.g., unsaturated and saturated groundwater flow under 

isothermal conditions, structural deformation and seismicity, and igneous activity). Within each 

KTI, NRC and CNWRA staff members developed a number of subissues that more closely 

matched specific components of the performance assessment (e.g., under unsaturated and 

saturated flow under isothermal conditions KTI, there were climate change, hydrologic effects of 

climate change, shallow infiltration, and saturated zone subissues; under total system 

performance assessment and integration KTI, there were system description and demonstration 

of multiple barriers, scenario analysis and event probability, model abstraction, and 

demonstration of compliance with the postclosure public health and environmental standards 

subissues). The prelicensing interactions related to specific KTI subissues; NRC provided the 

status of their resolution in its periodic Integrated Issue Resolution Status Reports.
3-1 

3 TYPES OF NRC-DOE PRELICENSING INTERACTIONS 

The DOE Office of Civilian Radioactive Waste Management (OCRWM) and the NRC Office of 

Nuclear Material Safety and Safeguards (NMSS) developed a set of mutually agreeable 

guidelines for conducting the prelicensing interactions. These guidelines contained in 

SECY–99–031, Agreement Between the U.S. Department of Energy Office of Civilian 

Radioactive Waste Management and U.S. Nuclear Regulatory Commission Office of Nuclear 

Material Safety and Safeguards Regarding Prelicensing Interactions (NRC, 1999) (referred to as 

the “Agreement” from here on) is reproduced as Attachment 1 to this document. Care was 

taken in developing this Agreement to ensure stakeholders that no action taken (e.g., resolution 

of technical issues) during these prelicensing interactions, “...shall be deemed to constitute a 

commitment to issue any authorization or license, or in any way affect the authority of 

the Commission...” 

An Appendix 7 meeting between NRC/NMSS and DOE/OCRWM was defined as 

An Appendix 7 meeting is a meeting between the NRC onsite 

representative (OR), including any NRC personnel assigned to the 

OR, and DOE-Yucca Mountain Site Characterization Office (YMSCO), 

including contractors and subcontractors (NRC, 1999). 

These meetings, described in Appendix 7 of the Agreement between DOE/OCRWM and 

NRC/NMSS (NRC, 1999), did not constitute official interactions between these two 

organizations, and did not require any written reports or meeting summaries. These meetings 

were focused discussions on technical topics related to site characterization and related 

activities. External parties could observe these meetings at the discretion of these two 

organizations. No commitments were made at the Appendix 7 meetings. 

A technical exchange between DOE and NRC was defined as 

A scheduled interaction between DOE and NRC technical/licensing staff 

expected to focus primarily on technical or regulatory issues and to: review and 

consult on interpretations of data; identify potential licensing issues; discuss 

specific technical and/or regulatory topics, the sufficiency of available information 

and data, methods and approaches for the acquisition of additional information, 

and data as needed to facilitate NRC reviews, and evaluations and for staff 

resolution of such potential licensing issues (NRC, 1999). 

Technical exchanges were used to understand and discus technical or regulatory issues and 

accept planned actions on the part of both agencies. However, they were not used to officially 

establish or change positions or make commitments. These meetings were open to the public. 

The character of these meetings changed during the later part of the program when, in addition 

to the technical staff, management also started to participate. These meetings then shared the 

characteristics of both a technical exchange and a management meeting (see next paragraph); 

thus, in addition to technical discussions, commitments could be made. 

Technical exchanges were formal meetings between DOE and NRC technical and licensing 

staff. These meetings focused primarily on mutually agreed, specific technical and regulatory 

topics. A teleconference between DOE/OCRWM and NRC/NMSS was held approximately 

2 weeks prior to a technical exchange meeting to reach agreement on the agenda (NRC, 1999). 

Stakeholders were present in these meetings and were invited to participate, including providing 
3-2 

comments at the beginning and closing of the meeting. These meetings followed a strict 

protocol and a published agenda. Feedback from the public was specifically sought. Concise 

minutes of the meetings were developed summarizing briefly the presentations made and 

discussions that took place, regulatory or technical interpretations or positions, and points of 

agreement or disagreement, including any commitments made. Copies of the presentations 

and list of attendees were included as attachments to the minutes and were distributed to the 

State of Nevada, affected units of local government, affected Indian tribes, and public document 

rooms of NRC and DOE. 

A site visit between NRC and DOE technical staff members was defined as 

A site visit is a scheduled interaction to explain technical information related to 

ongoing field or laboratory site characterization and related activities; visit 

locations at the site for field briefings; and discussions of preliminary data and 

interpretation derived from field work. 

A site visit did not require written reports or meeting summaries. Site visits were not used to 

officially establish or change technical and/or regulatory positions. No commitments were made 

and no course of action was agreed upon. Stakeholders were allowed to participate in site visits 

consistent with security requirements. 

A Management Meeting between DOE and NRC was defined as 

A scheduled interaction held whenever necessary to review the summary results 

of technical exchanges; to review the status of outstanding items and issues; to 

discuss plans for resolution of outstanding items and issues; to update the 

schedule of technical exchanges and other actions needed for staff resolution of 

open items regarding the site characterization program; and to consult on what 

guidance is advisable and necessary for NRC to prepare (NRC, 1999). 

Unresolved management issues would be promptly elevated to upper management for 

resolution. Management meetings were conducted to discuss programmatic issues related to 

program policy, schedules, scope, and major assignments of resources. Any commitments that 

were made during these meetings were documented in correspondence. 

In addition, another prelicensing activity, which was not classified as an interaction between 

DOE and NRC (NRC, 1999) but provided important insights into the ongoing DOE technical 

activities, was participation in DOE internal QA audits of its Management and Operating 

Contractor and subcontractors⎯including the national laboratories⎯by the NRC and CNWRA 

staff members as observers. The DOE QA organization was responsible for and conducted 

these audits. NRC observed these audits in lieu of NRC-led inspections and similar QA 

assessments, which significantly reduced NRC resource requirements and also limited the 

impact on organizations that might be inspected. NRC observer teams consisted of QA 

specialists and technical staff with expertise in the technical area being audited. 

Representatives from the State of Nevada, local governments, and Indian tribes also attended 

these audit activities as observers. The objectives of NRC observers were to determine the 

effectiveness of the DOE audit process and implementation of the QA programs being 

assessed. NRC observers provided their comments, observations, and recommendations to 

the DOE audit leader, and also produced a formal audit observation report that was made 

available to all stakeholders. 
3-3 

The four kinds of permissible meetings and interactions and their characteristics are defined in 

Table 3-1. In addition, biweekly Yucca Mountain status meetings between DOE and NRC 

project staff members and visits to the DOE Licensing Support Office (LSO) by NRC and 

CNWRA staff members are also discussed in Table 3-1. Furthermore, NRC participated as 

observers in DOE internal quality assurance audits. Characteristics of these audits are 

discussed in Table 3-1. 

As the prelicensing activities progressed, the nature of these interactions changed. For 

example, very early in the program, before about 1997, technical exchanges were the primary 

mode for direct interaction among DOE staff, DOE contractor scientists and engineers, NRC 

staff, and CNWRA scientists and engineers. These technical exchanges were relatively 

informal and even included field trips to examine volcanic features or paleoseismic trench 

investigations. They also included stakeholders (e.g., Nye and Clark counties) and the public, 

but involved few, if any, NRC or DOE managers. Appendix 7 meetings were used when a very 

small group of NRC staff members needed to interact with their DOE counterparts at the NRC 

onsite representative (OR) office in the presence of one of the NRC ORs. 

In early 2000, NRC initiated a more formal process to identify and then close outstanding 

technical issues with DOE. Within each subissue, NRC and CNWRA staff developed a series of 

questions, which were discussed with DOE at a series of meetings that combined the 

characteristics of both technical exchanges and management meetings. In general, one 

meeting was held for each KTI. Before each meeting, DOE and NRC would hold one or more 

teleconferences to discuss NRC questions and proposed DOE answers. Later, DOE responses 

were presented formally at the meetings. Based on the response, NRC and DOE developed 

agreements that needed formal responses from DOE to be closed. DOE developed technical 

reports and provided additional information to NRC for each agreement. NRC staff evaluated 

the information and either closed the agreement or asked for additional information necessary to 

close the agreement. 
Table 3-1. Types of NRC and DOE Prelicensing Interactions and Their Characte

Interaction Objective Characteristics Participants Discu

Appendix 7 Meeting 

●Discuss technical topics related 

to site characterization and related activities (e.g., field trips) 

●Nonscheduled interaction ●No commitments to be made ●External parties may be notified 

 and invited to observe 

●NRC onsite  representative (OR)  and NRC personnel  assigned to OR office ●DOE-Yucca Mountain  Site Characterization  Office (YMSCO) ●Contractors 

Written material distributed and a was not required was meant to be and in-depth dismatters. At the Appendix 7 meefor stakeholder pas DOE started application. 

Technical Exchange 

●Discuss technical and regulatory 

topics, data interpretation, potential licensing issues, sufficiency of available information and data, and approaches for acquiring additional information and data for resolution of potential licensing issues 

●Scheduled meeting ●Meeting open to public ●Could not be used to officially  establish or change positions  or make commitments ●Meeting summaries were  prepared, developed by DOE,  and reviewed by NRC 

●DOE and its  contractor staff ●NRC and its  contractor staff ●Members of the public 

Meeting and age

advance. In inititechnical staff of interacted withoumanagement. In program, managfrom both agencthese meetings c“management mcommitments comaterial was excmeeting. 

Site Visit ●Discuss technical information 

related to ongoing field and laboratory investigations and preliminary interpretations of field and laboratory data 

●Scheduled meeting ●No technical or regulatory  commitments to be made ●Written reports or meeting  summary not required ●Stakeholders invited as  observers 

●DOE and its  contractor staff ●NRC and its  contractor staff ●Members of the public 

Site visits providobserving field aand for making tits origin more tr

Management Meeting 

●Discuss summary results of 

technical exchanges 

●Identify outstanding items and 

 issues and plans for resolving  them 

●Update schedules of technical 

exchanges 

●Identify actions needed for staff 

resolution of open items 

●Identify guidance for NRC to 

prepare 

●Scheduled meeting ●Commitments on path to staff  resolution of technical,  programmatic, and regulatory  issues were made ●Written meeting summary with  commitments were required ●Stakeholders invited as  observers 

●DOE and its  contractor staff ●NRC and its  contractor staff ●Members of the public 

Management meforum to discuss programmatic, amake commitmestatus. Manageheld when needeon a quarterly scand members of window to the ovfrom the perspecthe implementer

3-4 
Table 3-1. Types of NRC and DOE Prelicensing Interactions and Their Characteristics 

Interaction Objective Characteristics Participants Discu

DOE Quality Assurance Audits 

●Observe DOE quality assurance  audits ●Assess effectiveness of DOE  audit process and  implementation of QA program 

●Scheduled meeting 

●No technical or regulatory  commitments to be made ●NRC participated as observer ●Stakeholder invited to observe 

●DOE, its management  and operating  contractor, including  the national  laboratories ●NRC project staff as  observers 

Participation in Daudit as observeof information on related to laboraobservations, meexperiments, anobserved the auinspections, whicresource require

Biweekly Status Meetings 

●Update status of the project ●Inform participants about  upcoming activities ●Discuss arrangements of  upcoming technical exchanges 

●Schedule meeting ●No technical or regulatory  commitment to be made 

●DOE and its  contractors project  staff ●NRC project staff 

CNWRA did not 

Licensing Support Office Visits 

• Consult DOE documents and 

computer models in draft form before they were publicly available 

• Not a meeting • No technical or regulatory 

commitments to be made 

• NRC and CNWRA 

Technical staff 

Availability of draNRC and CNWRimportant techni

3-5 
4-1 

4 CNWRA PERSPECTIVES ON EFFECTIVENESS OF INTERACTIONS 

4.1 Appendix 7 Meetings 

The Appendix 7 meetings between DOE and NRC started as informal meetings with focused 

discussion on selected technical topics. No written reports or meeting summaries were 

prepared consistent with the DOE-NRC agreement (NRC, 1999). Useful, in-depth discussions 

took place in these meetings. Although not barred from attending, stakeholders initially did not 

take much interest in these meetings, as evidenced by their limited attendance at 

these meetings. 

As DOE began to develop the license application for a permanent geologic repository at Yucca 

Mountain, stakeholders increased participation in Appendix 7 meetings. As DOE staff became 

mindful of the presence of stakeholders, meeting effectiveness decreased: discussions were 

less open among the technical staff of both organizations, and information was less 

forthcoming. The NRC and CNWRA staff members were not inclined to present information that 

was not close to “final,” and DOE staff presented only “tried and true” information. There was a 

sense that information on recent work was held back if it was not fully vetted within the 

respective organizations. Additionally, responses seemed to become well-rehearsed answers, 

reducing effectiveness and somewhat diminishing the original intent of these meetings. 

Furthermore, preparation time increased for Appendix 7 meetings. In addition, technical 

exchanges were favored over Appendix 7 meetings because NRC and DOE wanted to close 

open items within each KTI in a formal way. Lessons learned from the Appendix 7 meetings, as 

well as suggestions for improving effectiveness of similar meetings with potential applicants, are 

discussed in the following paragraphs. 

Lessons Learned 

• Appropriate staff members from the applicant should be available to explore the 

technical subject matters thoroughly, as intended. At some Appendix 7 meetings, 

appropriate staff members from DOE and its contractor were not available or available 

only on limited time basis. On the other hand, in some meetings, several DOE and 

contractor staff members were present who did not appear to be part of the focused 

discussion. Presence of too many persons sometimes imposed logistical issues and 

probably distracted from the discussion. 

• Documents (reports and associated materials) related to the topic(s) of discussion 

should be available to the NRC and CNWRA staff members well in advance of the 

meeting to prepare appropriately for the discussion. When the NRC and CNWRA staff 

members received the documents early and had adequate time to prepare, the 

discussion was focused and productive, resulting in an effective and fruitful information 

exchange. Both sides benefited from the discussion. The NRC and CNWRA staff 

members developed a better understanding of the technical issues and better 

understanding of DOE approaches, assumptions, data, and analyses. At the same time, 

DOE and its contractor staff understood NRC and CNWRA staff member concerns, if 

any, on the proposed approaches. Conversely, in one preclosure Appendix 7 meeting 

on application of human reliability in the Preclosure Safety Analysis (PCSA), many 

inquiries by NRC and CNWRA staff members on the DOE approach met resistance from 

DOE to discuss adequately. As a result, NRC and CNWRA staff members were not able 

to gain insight into how DOE would introduce human reliability in its PCSA. 
4-2 

• NRC and CNWRA staff should ensure that all participants understand the scope, intent, 

and restrictions imposed by the DOE and NRC agreement (NRC, 1999) on the Appendix 

7 meetings. For example, no agreements or commitments can be made in the Appendix 

7 meetings because they were not considered formal interactions between these two 

organizations. 

Suggestions for Improving Effectiveness 

The following suggestions are provided to improve the effectiveness of future Appendix 7 

meetings with similar scopes with potential licensees. 

• Information, such as reports, analyses, results, etc. related to the topic(s) of the meeting 

should be made available to NRC and CNWRA staff members well in advance so that 

staff attend the meeting with sufficient preparation. This may help in identifying the 

technical issues beforehand to keep the discussion focused on important topics. 

• The policy of not keeping any official notes should be strictly adhered to so that the 

discussion can be open, as intended in NRC (1999). 

• NRC and CNWRA staff should ensure that applicant staff members understand the 

purpose and objective(s) to be achieved. Valuable resources would be wasted if time 

were lost discussing unnecessary background materials and giving instructions on 

meeting constraints and purposes. 

• The role of the regulator, especially during prelicensing interactions, should be made 

clear to the applicant staff members present in the meeting (and in other types of 

meetings, such as technical exchanges and site visits). 

• NRC and CNWRA staff members should ensure that appropriate applicant staff 

members will be available for effective discussion in a meeting; otherwise, alternative 

date(s) for the meeting should be selected. Additionally, the applicant should include all 

staff members directly needed for the focused discussion. 

• It is necessary to design a convenient mechanism to readily share information as they 

are officially available, so NRC and CNWRA staff members do not have to ask for 

specific reports. 

4.2 Technical Exchanges 

Technical exchanges were held with the expectation that all risk-significant issues would be 

discussed, debated, and paths for resolution would be formulated in a mutually agreeable 

manner so that DOE could develop a high-quality license application for the geologic repository 

at Yucca Mountain, and NRC could conduct an efficient license review of such a complex 

project in the stipulated time period. Initially, technical exchanges worked well: discussions 

were in-depth on technical and regulatory issues; and good technical information was 

exchanged during the meetings. However, as DOE progressed toward preparing and 

submitting the license application, meetings became less effective, especially in the preclosure 

areas. Presentations generally dealt with familiar “tested” information (e.g., methodologies to be 

used). Additionally, the presentations did not provide much depth on risk-significant issues 

beyond what were on the slides. Responses to clarification questions tended to be superficial in 
4-3 

some cases and follow-up staff questions generally would not bring out any further information. 

This extremely cautious approach to the technical exchange meetings undermined the intended 

purpose of the meetings. 

Organizing technical exchanges (as well as Appendix 7 meetings) when DOE was preparing the 

license application became increasingly difficult. Technical exchanges appeared to be 

controlled by legal considerations and the format for information exchange became constrained, 

decreasing effectiveness of these exchanges. Although not stated, DOE may have been 

concerned that technical exchanges took resources that otherwise would be used to ensure on 

time completion of the license application. 

Lessons Learned 

• NRC and CNWRA staff members did not receive documents related to some technical 

exchanges sufficiently in advance to prepare effectively as a team. This may have 

affected focusing on risk-significant issues. This issue is similar to the one in 

Appendix 7 meetings. 

• NRC and CNWRA staff members lacked prior knowledge of some approaches DOE 

would adopt in the analyses in several areas before the license application was 

submitted. DOE did not agree to staff requests for a technical exchange on many 

risk-significant topics, especially when it was developing the license application. In the 

future, NRC staff should ensure that they have prior knowledge about the approaches to 

be taken by an applicant to implement a methodology in an analysis, especially in a 

risk-informed licensing review, so that the review can be more effective with minimum 

need for requests for additional information (RAIs). Prior knowledge of the approaches 

used in the analyses would have facilitated reviewing the license application more 

effectively and minimized the need for RAIs. 

• Level of design details that would be included in the license application was a long 

standing issue that was not successfully resolved before submittal of the license 

application. As specified in the regulations at 10 CFR Part 63, PCSA should be used to 

identify the Structure Systems and Components (SSCs) important to safety that would 

be relied upon to prevent or mitigate the radiological consequences as a result of an 

initiating and associated event sequences. In addition, it should be shown in the license 

application that the design of the importance to safety SSCs would provide reliabilities of 

the systems and components, at least what had been assumed in assessing safety of 

the facility and operation in the PCSA. It is important for NRC staff and the applicant to 

have a clear and common understanding of the level of design details expected in the 

license application. The level of design details should focus on the information needed 

for appropriate review of the license application using the standard review plan 

[e.g., Yucca Mountain Review Plan (NRC, 2003)]. NRC staff developed an interim staff 

guidance (ISG) HLWRS–ISG–02 Preclosure Safety Analysis-Level of Information and 

Reliability Estimation (NRC, 2007), to address the level of design details. The ISG 

provides the level of design and operational details necessary for SSCs at the geologic 

repository operations area and examples that illustrate commonly used approaches for 

estimating reliability of an SSC. NRC staff presented the level of design details 

necessary in the license application through examples in a technical exchange. 

However, lack of sufficient information at the system and component levels in the license 

application made it difficult to trace an event sequence all the way through the design 

and, ultimately to the assigned reliability value. Had DOE presented a detailed, 
4-4 

“real-life” example of reliability assessment of a system in a technical exchange, instead 

of high-level discussion of its approaches or methodologies, the need for sufficient 

design details and information for an acceptable quality PCSA would have been clear 

and fewer RAIs would have been needed for reviewing the license application. 

Suggestions for Improving Effectiveness

• Topics and scope of a technical exchange (as well as an Appendix 7 meeting) should be 

established well in advance of the meeting. Staff should focus on topics relevant to risksignificant issues. For example, discussion of both methodologies and application of 

these methodologies to an actual problem are important to risk-informed reviews. 

Definition of the problem, assumptions made, and implementation of the methodologies 

in actual analyses may affect significantly the outcome of the analyses. Consequently, 

the meetings should address both of these aspects with appropriate emphasis, instead 

of concentrating on one (e.g., only discussing methodologies). 

• Any interim staff guidance or other instructions to the applicant must be timely to be 

effective. Developing guidance earlier in the process, and updating it as necessary 

based on knowledge gained from applicant interactions, would have helped clarify NRC 

staff expectations and may have resulted in fewer RAIs. 

• NRC and CNWRA staff members should develop risk insights regarding the outstanding 

technical issues as early as possible and focus on meeting with the applicant on risksignificant issues. NRC and CNWRA staff members should connect technical questions 

to total system performance or PCSA, as appropriate. NRC and CNWRA staff took time 

to develop and apply risk insights as part of the technical review. Furthermore, NRC and 

CNWRA staff members sometimes struggled with the difference between “a sound 

technical approach with defensible technical conclusions” and “a technical approach and 

conclusions good enough to reach a safety decision.” As a result, some technical 

exchanges (also Appendix 7 meetings) devoted too much time to scientific or technical 

issues that were not necessarily risk significant. 

4.3 Site Visits 

Site visits in which the NRC and CNWRA staff members had the opportunity to meet with DOE 

and its contractors in the field in order to directly observe ongoing studies were an important 

component of the prelicensing review activities. Often these site visits were conducted as new 

information was being developed or new experiments were started. Examples include several 

site visits by NRC and CNWRA staff members to meet with DOE counterparts to observe 

paleoseismic records unearthed as new fault trenches were excavated, core recoveries as new 

drill holes were drilled, and the drift-scale heater test. In addition, the NRC and CNWRA staff 

members conducted their own field and laboratory experiments (e.g., Ferrill et al., 1996; 

Stamatakos et al., 2007). These independent analyses assisted the NRC and CNWRA staff 

members to develop their technical perspectives early and present their assessments in 

interactions with DOE and its contractor staff members. In some cases, DOE conducted 

additional field and/or laboratory studies to improve the quality of the license application. 

Lessons learned from site visits are given in the following section. There are no suggestions for 

improving the site visits. 
4-5 

Lessons Learned 

• The site visits provided opportunities to become more fully informed reviewers, who 

have observed collection of site-related information that formed the basis for developing 

the license application. 

 

• Independent field data collections and limited scale experiments by NRC and CNWRA 

staff members were essential in developing position(s) on complex technical issues. In 

addition, conducting limited-scale field experiments helped staff guard against possible 

biases regarding field observations made by the applicant. 

4.4 NRC-DOE Management Meetings 

These formal meetings were held quarterly with participation from senior level NRC and DOE 

managers, often including office directors. Policy and management matters were discussed and 

action items were tracked. These meetings were open to stakeholders and time was allocated 

for stakeholder statements. Participants often read prepared statements and these meetings 

rarely deviated from the agenda. Meeting notes were kept and tracking action items included 

assigning responsibility and completion dates. These meetings were useful in ensuring that the 

highest levels of management were engaged and aware of the status of the project and any 

ongoing programmatic, management, or technical issues that needed to be resolved. 

Effectiveness of management controls and implementation of the DOE quality assurance 

program were permanent topics for these meetings. 

Lessons Learned 

• The formality of the meeting in the presence of high levels of management constrained 

discussion to planned thoughts and statements, thus discouraging a free exchange of 

views. However, these meetings met their objective of making public high-level 

management concerns related to policy, work quality, schedules, and other important 

matters that may have affected timely actions by either DOE or NRC. 

• The meetings were effective in exposing DOE and stakeholders to NRC expectations 

with respect to the license application and to DOE plans for meeting these expectations. 

4.5 Observations of DOE Quality Assurance Audits 

Observation of DOE QA audits also provided a good source of information on ongoing DOE 

activities related to laboratory experiments; field observations, measurements, and experiments; 

and analyses. The NRC staff could factor this knowledge into its development of regulations, 

regulatory guides, and other regulatory documents, in addition to preparing for license 

application review. Lessons learned and suggestions for improving future interactions are given 

in the following paragraphs. 

Lessons Learned 

• The audit observation process provided an effective method for assessing quality 

assurance program implementation that would otherwise have required 

NRC-led inspections. 
4-6 

• The DOE-NRC agreement (NRC, 1999) placed constraints on audit observations and 

observers that, on some occasions, conflicted with the need to obtain detailed 

information on ongoing DOE activities. 

• Active participation by audit observers required careful balancing to avoid interfering with 

the audit team while providing timely observations to the audit team to avoid any 

potential surprises at the end of the audit. In some instances, the DOE audit team took 

the recommendations of NRC observers into account in their own recommendations to 

DOE (e.g., NRC, 2005). 

Suggestions for Improving Effectiveness 

• Future agreements should explicitly address audit observation activities to ensure 

sufficient detail is obtained about ongoing licensee activities. Technical observers 

should be instructed on proper conduct before each audit observation activity. 

• Specific time should be allocated each day for observers to discuss their observations 

with the audit team. This would allow timely feedback to the audit team and avoid 

delaying the audit team. The audit observers should focus on implementation of 

the QA program rather than on technical details of analyses conducted by the 

potential applicant. 

4.6 Biweekly Yucca Mountain Status Meetings 

Informal biweekly Yucca Mountain status meetings were held between NRC and DOE project 

staff without participation of stakeholders. The meetings updated the status of the project and 

informed participants of any forthcoming activities, including arrangements for technical 

exchanges. Because CNWRA staff generally did not attend these meetings, there is no 

discussion on lessons learned or suggestions for improving such interactions with a 

future applicant. 

4.7 Visits to the DOE Licensing Support Office 

DOE created the LSO to allow NRC and CNWRA staff members to consult DOE documents 

that were in draft form and not yet publicly available. NRC routinely requested documents to be 

included in the LSO collection. DOE also made available in the LSO draft computer models, 

such as the total system performance assessment model developed in GoldSim (GoldSim 

Technology Group, LLC, 2004), for NRC and CNWRA staff members to become familiar with 

DOE approaches. Documents were not allowed to be taken outside the LSO facility. In 

general, availability of draft documents at the LSO benefitted both DOE and NRC by allowing 

early sharing of important technical information. For example, the NRC and CNWRA staff 

benefitted from learning early of planned changes in DOE performance assessment models. 

There are no lessons learned and suggestions for improvement for visits to the DOE LSO. 

4.8 Public Outreach Meetings 

Public meetings were one of the most important methods of communication in the NRC Yucca 

Mountain public outreach program. These meetings served as a tool to educate and inform the 

public, as well as to gather important feedback and input for NRC decision making. The 

process and format of public meetings evolved as more experience was gained. Staff learned 
4-7 

many important lessons throughout the program that contributed to continued improvement and 

overall success. 

The outreach program related to the Yucca Mountain repository started when 10 CFR Part 63 

was in a draft stage. The first public meeting on Yucca Mountain issues was held in March 

1999, to explain, gather additional input, and hear concerns from the general public and 

stakeholders about proposed rulemaking. 

Over the years, several public meetings were held at different sites in Nevada on various topical 

areas, including roles and responsibilities of NRC, NRC licensing process, Licensing Support 

Network, and the NRC hearing process. Insights gained from these public outreach meetings 

and interactions with stakeholders also benefitted other programs at NRC. In 2003, NRC began 

to recognize needs to increase stakeholder confidence in NRC. Members of the public outreach 

team were invited to join the Commission’s task force for evaluating public communications and 

providing strategies for enhancing communications at all levels of the agency. History and 

lessons learned from these public outreach meetings are elaborated in a separate report 

Lessons Learned From Public Outreach Meetings,1

 only pertinent points are presented here. 

Lessons Learned 

• Knowledge of risk communication and preparation for anticipated follow-up questions 

help significantly in success of the meetings. 

• An adequate number of NRC staff should be in the team for proper preparation for a 

public meeting. Additionally, team members should be encouraged to contribute freely, 

regardless of their position level in the agency. 

• It is important to visit the venue ahead of time to ensure proper facility size, ancillary 

equipment, and seating accommodations. 

• Dry runs of presentations to be delivered at the meeting help significantly in preparing for 

the meeting. 

• Makeup of a community can affect the course and reception of a public meeting. 

Consequently, anticipate concerns of the community and explain how to put those 

concerns forward to appropriate regulatory bodies. 

• NRC and CNWRA staff members should be prepared to deal with an elected official in 

the audience who may use the meeting as a personal campaign venue. Staff should be 

courteous to him or her and should answer the questions; however, staff should keep 

the discussion on the topic. 

• Transcripts of the discussion should be prepared, which will help in sharing information 

about the meeting with the members of the public who could not attend. Transcripts are 

also helpful for internal review and demonstration of compliance with agency policies. 

 

1

Submitted on April 7, 2011, to NRC as an intermediate milestone (14002.01.441.110) of CNWRA. 
4-8 

Suggestions for Improving Effectiveness 

• NRC and CNWRA staff members should ensure that the members of the public feel 

welcome in the public outreach meetings. Staff should not be defensive; however, 

preparation for unforeseen scenarios (e.g., security issues) should be accounted for in 

planning a public meeting. 

 

• NRC and CNWRA staff members should prepare presentations in plain language for 

effective communication with the public. 

• It is important to have the right staff members on hand to answer questions in a public 

outreach meeting. Both well-prepared technical experts ready to answer technical 

questions and legal staff to assist with policy and regulatory matters are needed. 

• NRC and CNWRA staff members should ensure that stakeholders see evidence that 

their concerns are being heard.
5-1 

5 SUMMARY 

Several different modes of interaction between DOE and NRC and CNWRA staff members were 

available to discuss, understand, and resolve potentially complex technical issues during the 

prelicensing phase. The protocols and restrictions, if any, of each type of interaction are 

described in SECY–99–031 (NRC, 1999). Each type had a different degree of success in 

fulfilling its objectives. In general, the effectiveness of Appendix 7 meetings and technical 

exchanges decreased when only “tried and true” information was presented, holding back any 

information about new work or approaches before it is fully vetted within the DOE organization 

and presentations and responses were too rehearsed. The effectiveness of these interactions 

declined further when DOE was preparing to submit the license application. In a project with 

significant complex technical issues with mandatory time limits on completing the review, it is 

essential that technical staff from both sides interact as early and effectively as possible to 

resolve the issues. A convenient mechanism is needed to readily share information as it 

becomes available for distribution.
6-1 

6 REFERENCES 

Ferrill, D.A., J.A. Stamatakos, S.M. Jones, B. Rahe, H.L. McKague, R.H. Martin, and 

A.P. Morris. “Quaternary Slip History of the Bare Mountain Fault (Nevada) from the Morphology 

and Distribution of Alluvial Fan Deposits.” Geology. Vol. 24. pp. 559–562. June 1996. 

GoldSim Technology Group, LLC. “GoldSim Probabilistic Simulation Environment.” Issaquah, 

Washington: GoldSim Technology Group, LLC. 2004. 

NRC. “Preclosure Safety Analysis—Level of Information and Reliability Estimation.” Interim 

Staff Guidance HLWRS–ISG–02. Washington, DC: NRC. 2007. 

–––––. “Audit of Bechtel SAIC Company, LLC, OCRWMP–OQA–05–11, Project Engineering 

and Records Management and Document Control.” Observation Audit Report OAR–05–06. 

Washington, DC: NRC. 2005. 

–––––. “Yucca Mountain Review Plan⎯Revision 2.” Washington, DC: NRC. 2003. 

–––––. “Agreement Between U.S. Department of Energy/Office of Civilian Radioactive Waste 

Management and U.S. Nuclear Regulatory Commission/Office of Nuclear Material Safety and 

Safeguards Regarding Prelicensing Interactions.” SECY–99–031. Washington, DC: 

NRC. 1999. 

Stamatakos, J.A., S. Biswas, and M. Silver. “Supplemental Evaluation of Geophysical 

Information Used to Detect and Characterize Buried Volcanic Features in the Yucca Mountain 

Region.” San Antonio, Texas: Center for Nuclear Waste Regulatory Analyses. August 2007.
ATTACHMENT 

SECY–99–031 
1 

SECY–99–031 

January 28, 1999 

FOR: The Commissioners 

FROM: William D. Travers /s/ 

Executive Director for Operations 

SUBJECT: AGREEMENT BETWEEN U.S. DEPARTMENT OF ENERGY/OFFICE OF 

CIVILIAN RADIOACTIVE WASTE MANAGEMENT AND U.S. NUCLEAR 

REGULATORY COMMISSION/OFFICE OF NUCLEAR MATERIAL 

SAFETY AND SAFEGUARDS REGARDING PRE-LICENSING 

INTERACTIONS 

PURPOSE: 

To inform the Commission of a revision to the agreement between the U.S. Department 

of Energy (DOE), Office of Civilian Radioactive Waste Management (OCRWM), and the 

U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Material Safety and 

Safeguards (NMSS), regarding general guidelines for communications between the two 

organizations with respect to all activities preparatory to DOE's submission of an 

application for authorization to construct and operate a geologic repository under 

section 114 of the Nuclear Waste Policy Act (NWPA). 

BACKGROUND: 

In 1983, NRC and DOE signed a Procedural Agreement and later a Project-Specific 

Agreement identifying guiding principles for interface during site investigation and site 

characterization. The agreements outlined procedures, for consultation and exchange of 

information that DOE and NRC would observe in connection with the characterization of 

sites for a geologic repository. The purpose of these procedures is to assure that an 

information flow was maintained, between the two agencies that will facilitate each 

agency's accomplishment of its responsibilities, under the NWPA. This agreement was 

last revised in 1993. 

DISCUSSION: 

The objective of this revision (attached) is to update, consolidate, and streamline the 

agreement. NRC and DOE staffs have worked jointly to incorporate changes to satisfy 

these objectives. The substantive changes include: (1) adding a provision stating that 

all interactions will comply with the "NRC Policy Statement on Staff Meetings Open to 

the Public"; (2) stating that management commitments will be documented in 

correspondence subsequent to the interactions; (3) streamlining the types of meetings 
2 

conducted to reflect current practice; (4) consolidating and eliminating redundant 

information to simplify the agreement; and (5) clarifying the use of terms by adding a 

"Definitions" section. 

All changes to this agreement have been coordinated with DOE/OCRWM and reviewed 

by NRC/NMSS, and NRC's Office of the General Counsel (OGC). In an August 1998 

public meeting, NRC and DOE staffs briefed representatives from the State of Nevada, 

Affected Units of Local Governments (AULGs), and other interested parties, on the 

proposed revision to the agreement, and solicited their comments. Copies of the 

proposed revised agreement were available at this meeting. Comments received from 

the State and AULGs were incorporated into the agreement. 

OGC has reviewed the procedural agreement and has no legal objection. There are no 

resource, information management, or information technology impacts expected as a 

result of the revised Procedural Agreement. 
3 

William D. Travers 

Executive Director for Operations 

CONTACT: Chad J. Glenn, NMSS/DWM 

(702) 794-5046 

Attachment: Agreement Between DOE/OCRWM and NRC/NMSS Regarding Prelicensing Interactions 

ATTACHMENT 

AGREEMENT BETWEEN DOE/OCRWM AND NRC/NMSS REGARDING 

PRELICENSING INTERACTIONS 

November 16, 1998

1 PURPOSE 

1.1 This Prelicensing Agreement describes general guidelines for communications 

between the staffs and management organizations of the Department of Energy 

(DOE) Office of Civilian Radioactive Waste Management (OCRWM) and the 

Nuclear Regulatory Commission (NRC) Office of Nuclear Material Safety and 

Safeguards (NMSS), including senior management and contractors designated 

by either agency, during the prelicensing period with respect to all activities 

preparatory to DOE's submission of an application for authorization to construct 

and operate a geologic repository under section 114 of the Nuclear Waste Policy 

Act (NWPA). 

1.2 This Prelicensing Agreement supersedes the Procedural Agreement@ and the 

Project-Specific Agreement", as revised in 1993. 

1.3 No action taken pursuant to this agreement shall be deemed to constitute a 

commitment to issue any authorization or license, or in any way affect the 

authority of the Commission, its officers, and staff, in any licensing proceeding. 

1.4. Nothing in this agreement shall be construed to confer rights to any party other 

than to DOE and NRC. 

2 DEFINITIONS 

Appendix 7 Meeting - An Appendix 7 Meeting is a meeting between the NRC On-Site 

Representative (OR), including any NRC personnel assigned to the OR, and DOEYucca Mountain Site Characterization Office (YMSCO), including contractors and 

subcontractors. These meetings, described in Appendix 7 of this Agreement, do not 
4 

constitute interactions within the intent of Section 3 of this agreement and will not 

require the preparation of written reports or meeting summaries. These meetings are 

intended to be focused discussions of technical topics on site characterization and 

related activities. At the discretion of DOE and NRC, external parties may be notified 

and invited to observe Appendix 7 meetings and field trips subject to identification 

requirements and compliance with applicable access control measures for security, 

radiological protection, and personnel safety. No commitments may be made at 

Appendix 7 Meetings. 

Commitments⎯An explicit statement to take a specified action agreed to or volunteered 

by the OCRWM or NMSS to one another, an external governmental agency or entity 

identified in the NWPA as having a right to participate. Commitments require action 

within a specified period or by a specified date. All commitments will be documented in 

correspondence by the party(ies) making the commitment. Unless expressly provided 

in writing, no commitments made to NRC pursuant to this prelicensing agreement are to 

be interpreted as becoming licensing commitments or conditions. 

Interactions⎯Technical Exchanges, Management Meetings, or Site Visits. 

Management Meetings and Technical Exchanges are planned interactions open to 

public observation subject to the NRC Policy Statement: Staff Meetings Open to the 

Public. Technical Exchanges or Management Meetings include but are not limited to 

planned or scheduled DOE/NRC face-to-face meetings as well as alternative forms of 

planned or scheduled DOE/NRC interactions such as videoconferences. These 

interactions will comply with the NRC Policy Statement: Staff Meetings Open to the 

Public whether conducted by NRC or DOE. Certain interactions require written reports, 

as described in Section 3.5, and are subject to public notification and observation. 

Management Meeting⎯A scheduled interaction held whenever necessary to review the 

summary results of Technical Exchanges; to review the status of outstanding items and 

issues; to discuss plans for resolution of outstanding items and issues; to update the 

schedule of Technical Exchanges and other actions needed for staff resolution of open 

items regarding the site characterization program; and to consult on what guidance is 

advisable and necessary for NRC to prepare. Unresolved management issues will be 

promptly elevated to upper management for resolution. Management Meetings are 

conducted to discuss programmatic issues related to program policy, schedules, scope, 

and major assignments of resources. Any commitments that are made during these 

meetings will be documented in correspondence by the party(ies) making the 

commitment. These meetings are subject to the NRC Policy Statement: Staff Meetings 

Open to the Public whether conducted by NRC or DOE. 

Observers⎯A representative(s) sent to primarily observe but not participate 

substantially in an activity (as in a meeting, audit, or surveillance). Observers may 

furnish questions, observations, and recommendations generally at the beginning and 

end of meetings. Direct communication between observers and meeting participants 
5 

during a meeting, audit, or surveillance is generally discouraged in order to minimize 

disruption. 

Programmatic Issues⎯Issues discussed primarily at Management Meetings related to 

program policy, schedules, scope, and major commitments of resources. 

Site Visit⎯A scheduled interaction held between DOE and NRC technical staff to: 

explain technical information related to ongoing field or laboratory site characterization 

and related activities; and visit locations at the site for field briefings and discussions of 

preliminary data and interpretation derived from field work. The primary purpose of a 

Site Visit is for both agencies to benefit from discussion of technical topics in the field. 

Site Visits will not require the preparation of written reports or meeting summaries. Site 

Visits will not be used as a forum to officially establish or change technical and/or 

regulatory positions, establish commitments, nor agree to courses of action. 

Representatives from the State of Nevada, affected units of local government, any 

affected Indian tribes, the public, and other interested parties may observe the 

proceedings of Site Visits consistent with security access, logistical arrangements, and 

safety rules. Proceedings covered by Appendix 7 of this agreement do not apply to Site 

Visits. 

Technical Exchange⎯A scheduled interaction between DOE and NRC 

technical/licensing staff expected to focus primarily on technical or regulatory issues 

and to: review and consult on interpretations of data; identify potential licensing issues; 

discuss specific technical and/or regulatory topics, the sufficiency of available 

information and data, methods and approaches for the acquisition of additional 

information, and data as needed to facilitate NRC reviews and evaluations and for staff 

resolution of such potential licensing issues. Technical Exchanges may be the forum 

for gaining an understanding and discussing technical or regulatory issues and the 

acceptability of actions on the part of both agencies, however, they can not be used to 

officially establish or change positions or make commitments. These meetings are 

subject to the NRC Policy Statement: Staff Meetings Open to the Public whether 

conducted by NRC or DOE. 

3 GUIDELINES TO CONDUCT OCRWM AND NMSS INTERACTIONS 

3.1 OCRWM and NMSS may conduct interactions on topics of mutual agreement at 

the request of either agency. Open, scheduled interactions may be either 

Management Meetings, Technical Exchanges, or Site Visits (see Section 2, 

"Definitions"). Proceedings covered by Appendix 7 of this agreement do not 

constitute interactions within the context of this agreement. 

3.2 Technical Exchanges are expected to focus on technical or regulatory issues, 

and are intended to be staff-to-staff interactions, with respective contractor staff 

included as needed. Technical Exchanges may be the forum for gaining an 

understanding and discussing technical or regulatory issues and the acceptability 
6 

of actions on the part of both agencies, however, they cannot be used to officially 

establish or change positions or make commitments. 

3.3 Management Meetings are generally expected to focus on programmatic issues. 

Verbal agreements can be made by the managers attending Management 

Meetings; however, any commitments will be documented in accordance with 

Section 3.5 of this agreement. 

3.4 A teleconference between OCRWM and NMSS should be held approximately 

two weeks before each Technical Exchange and Management Meeting to reach 

agreement on an agenda. 

3.5 Technical Exchanges and Management Meetings shall have bilateral minutes 

that summarize and document the meeting. The concise bilateral minutes shall 

include: (i)) brief summaries of the presentations made and the discussions held; 

(ii) regulatory or technical interpretations or positions; (iii) identification of points 

of agreement and disagreement; and (iv) documentation of commitments made 

at Management Meetings by either organization. Attachments are to include a 

list of attendees and copies of presentation materials and any view graphs used 

at the meeting. Copies will be provided to the State, affected units of local 

government, affected Indian Tribes, and the NRC and DOE Public Document 

Rooms. 

3.6 Representatives from the State of Nevada, affected units of local government, 

any affected Indian tribes, the public, and other interested parties may observe 

the proceedings of Technical Exchanges, Management Meetings, or Site Visits 

consistent with security access, logistical arrangements, and safety rules. Such 

representatives may provide comments at the opening and ending of the 

meeting. 

3.7 Consistent with NRC Policy Statement: Staff Meetings Open to the Public, the 

NRC will assume the lead to keep all parties informed about schedules for all 

OCRWM and NMSS Technical Exchanges, Management Meetings, and Site 

Visits. 

3.8 Unscheduled OCRWM-NMSS communications may occur by telephone, 

electronic mail, or in person. Unscheduled communications shall not be a 

substitute for an interaction as defined in Section 2 of this procedure. 

3.9 Closed, scheduled interactions between OCRWM and NMSS may also be held, 

according to the limited exemptions and circumstances described in the NRC 

Policy Statement: Staff Meetings Open to the Public. 

3.10 At the invitation of OCRWM and consistent with NRC policy, NRC staff may 

attend OCRWM sponsored or conducted meetings as observers and may 
7 

participate by providing comments. An OCRWM meeting attended by NRC staff 

as an observer shall not be a substitute for an interaction as defined in Section 2 

of this procedure. 

3.11 Both OCRWM and NMSS will identify management points of contact who have 

signature authority for correspondence to the other organization. Each 

organization will identify points of contact for informal communications and 

questions and will update these points of contact as necessary. 

3.12 NMSS staff, and consistent with security access and safety rules, representatives 

from affected units of state, local governments, and Indian Tribes, may 

participate as observers at OCRWM quality assurance audits and surveillances 

provided that such participation does not unreasonably interfere with or delay 

such audits and surveillances. The OCRWM audit team leader is responsible for 

the direction of the audit. Observers are encouraged to participate fully by 

furnishing their questions, observations, and recommendations in written form to 

the team leader (or sub-team leader). All inquiries will be addressed. NMSS 

may perform audits of OCRWM and OCRWM contractor quality assurance 

programs. Quality assurance audits and surveillances are not considered 

interactions in the context of this agreement. 

3.13 Interactions between NMSS and DOE program offices other than OCRWM 

concerning activities preparatory to DOE's submission of an application for 

authorization to construct and operate a geologic repository under Section 114 of 

the NWPA will be conducted in accordance with the provisions of this agreement. 

3.14 Guidelines specific to project activities are included in the appendices to this 

Agreement. 

3.15 The terms of this Agreement regarding these interaction guidelines may be 

amended at any time by mutual consent, in writing. This agreement and 

subsequent revisions will become effective upon the date of issuance. 

3.16 Appendix 7, “Agreement Concerning the Nuclear Regulatory Commission OnSite Representatives for the Repository Project Prior to Licensing”, provides a 

description of activities of the NRC On-Site Representatives. 
8 

______________________________________ 

 ____________________ 

Lake Barrett, Acting Director Date 

Office of Civilian Radioactive Waste Management 

U.S. Department of Energy 

______________________________________ 

 ____________________ 

Martin J. Virgilio, Deputy Director Date 

Office of Nuclear Material Safety and Safeguards 

U.S. Nuclear Regulatory Commission 
9 

APPENDIX 1 

AGREEMENT BETWEEN YMSCO AND NMSS EFFECTIVE PRIOR 

TO THE SUBMITTAL OF A LICENSE APPLICATION 

Appendix 1 specifies and implements provisions for activities and communication during 

the prelicensing period that may occur between the DOE Yucca Mountain Site 

Characterization Office (YMSCO) and the NRC Office of Nuclear Material Safety and 

Safeguards (NMSS) under the “Agreement Between DOE/OCRWM and NRC/NMSS 

Regarding Prelicensing Interactions.” The activities include: (i) identifying YMSCO and 

NMSS points of contact for formal communications and informal points of contact for 

other communications and questions; (ii) accessing data, documents, and records by 

YMSCO and NMSS; and, (iii) accessing YMSCO site characterization samples and 

collection of samples by NMSS and contractor staff. Nothing in this Appendix shall be 

construed either to modify the “Agreement Between DOE/OCRWM and NRC/NMSS 

Regarding Prelicensing Interactions” in any way or to confer rights on any party other 

than YMSCO and NMSS. 

1.0 Identification of YMSCO and NMSS Points of Contact 

Points of contact identified by YMSCO and NMSS, for formal and informal 

communications, will be transmitted to the other organization through the point of 

contact designated for formal communication. Point of contact information will include 

the names of all points of contact, designation for formal or informal communication, 

their mailing and e-mail addresses, and telephone and fax numbers. YMSCO 

designates the following individual as the point of contact for formal communications 

with NMSS: 

Assistant Manager for Licensing 

Yucca Mountain Site Characterization Office 

Office of Civilian Radioactive Waste Management 

U.S. Department of Energy 

P.O. Box 30307 

North Las Vegas, NV 89036-0307 

NMSS designates the following individual as the point of contact for formal 

communications with YMSCO: 

Director 

Division of Waste Management 

Office of Nuclear Material Safety and Safeguards 
10 

U.S. Nuclear Regulatory Commission 

11545 Rockville Pike 

Two White Flint North 

Rockville, MD 20850 

2.0 Access to Site Data, Documents and Records 

2.0.1 Written responses will be provided to written questions, comments, requests for 

data, samples, or documents, and requests for evaluations that are made by 

either YMSCO or NMSS. Requests by either organization for large data sets are 

subject to negotiation of a schedule for availability. The requesting organization 

is responsible for obtaining and providing to the responding organization any 

clearances needed for internal reproduction of published documents covered by 

copyrights. 

2.0.2 YMSCO has developed and will maintain a data base identifying site 

characterization technical data collected by YMSCO, except those data 

excludable by law. The information contained in this data base includes a 

description of the data, dates when the data were acquired or developed, the 

quality assurance status of the data, and the storage location of the data. 

2.0.3 Data sets from the YMSCO technical data management system are available to 

the NMSS upon written request. Requests must specify the data sets’ 

identifications to enable retrieval from YMSCO’s Technical Data Base, and 

format parameters, such as hard copy or electronic format, and any other 

applicable format items, needed to assemble and provide the data. All data 

provided by the DOE to the NRC prior to the submittal of the License Application 

are given with the following caveat: “CAUTION: Interpretations based upon 

these data are subject to change as more data are acquired, developed, or 

evaluated.” 

2.0.4 Upon request, at NRC's or DOE's option, each organization will provide the other 

at least one controlled copy of any specially developed or modified 

noncommercial software and available documentation used to evaluate site 

characterization and related activities, performance assessments, and design 

analyses subject to resolution of proprietary, privileged, software licensing 

agreements, and availability of the code. 

2.0.5 OCRWM records or documents must be authorized as available by YMSCO 

staff. Generally, records and documents that have completed a final DOE review 

shall be made available to the ORs upon request; however, DOE shall only 

provide access to view but not to copy or retain materials that are in preparation, 

if such access is specifically requested by the ORs. Records or documents may 

not be authorized as available by contractor staff. 
11 

3.0 Sample Access, and Sample and Data Collection by NMSS and Contractor 

Staff 

Written requests from NMSS for collection of samples or field data will be reviewed for 

acceptance by YMSCO to ensure that the collection will not compromise site 

characterization and related activities, that procedures have been established for the 

collection of the sample(s) or data and provided that such requests do not unreasonably 

interfere with site characterization and related activities. Once a request has been 

accepted, YMSCO will arrange for timely collection of the sample(s) or data according 

to applicable YMSCO procedures, and prepare and ship the sample(s) or transmit the 

data. If collection and/or transport of the sample(s) or collection and/or transmittal of the 

data will be delayed, YMSCO will notify NMSS of the proposed schedule for collection 

and delivery. 

If samples must be collected by NMSS or contractor staff, NMSS or contractor staff will 

follow applicable YMSCO, DOE Nevada Operations Office, and Nellis Air Force Base 

procedures and fulfill specified training requirements for access to the sample site(s), 

including surface and underground access control, site security, radiological safety, 

personnel safety, and protection of wildlife and the environment. For example, if 

samples or data are to be collected by NMSS or contractor staff, the NMSS and 

contractor staff will use YMSCO=s sample acquisition and handling procedures to 

obtain samples acquired as part of the site characterization program. Requests will be 

made in writing for samples for which no process of acquisition has been identified in a 

YMSCO procedure. YMSCO will review the request with NMSS staff to ensure that the 

location of the sample or the amount of sample material does not adversely impact the 

needs of the site characterization program. If no adverse impacts are identified, 

YMSCO will arrange for the NRC to receive or collect the requested materials. NMSS 

will request, through the YMSCO Project Manager, use of DOE rights-of-way for access 

to sample collection sites and will comply with the land access and environmental 

protection requirements. 

___________________________________ 

 ____________ 

J. Russell Dyer, Project Manager Date 

Yucca Mountain Site Characterization Office 

Office of Civilian Radioactive Waste Management 

U.S. Department of Energy 

___________________________________ 

 ____________ 

John T. Greeves, Director Date 
12 

Division of Waste Management 

Office of Nuclear Material Safety and Safeguards 

U.S. Nuclear Regulatory Commission 
13 

APPENDIX 2 - OWAST [RESERVED] 

This appendix is reserved for any future agreement applying to communications 

between the Department of Energy (DOE) Office of Civilian Radioactive Waste 

Management (OCRWM) and the Nuclear Regulatory Commission (NRC) Office of 

Nuclear Material Safety and Safeguards (NMSS) related to spent fuel storage or 

transportation authorized under the Nuclear Waste Policy Act (NWPA) and any future 

amendments to the NWPA. Such an agreement will become effective upon an 

exchange of letters between the parties agreeing to adopt this agreement for such 

activities. 
14 

APPENDIX 3 - OTHER DOE PROGRAM OFFICES [RESERVED] 

APPENDIX 4 - NRC POLICY STATEMENT: STAFF MEETINGS OPEN TO THE 

PUBLIC 

APPENDIX 5 – RESERVED 

APPENDIX 6 – RESERVED 
15 

APPENDIX 7 

AGREEMENT CONCERNING THE NUCLEAR REGULATORY COMMISSION ONSITE REPRESENTATIVES FOR THE REPOSITORY PROJECT PRIOR TO 

LICENSING 

The purpose and objective of the on-site representative (OR) is to serve as a point of 

prompt informational exchange and consultation, to preliminarily identify concerns about 

investigations relating to potential licensing issues, and to serve as a point of contact for 

informal communications between NMSS and YMSCO. This appendix is intended to 

supplement the base agreement and to detail the guidelines which will govern 

communication between the NRC OR, including any NRC personnel assigned to the 

OR, and DOE and its contractor personnel (prime and sub) through the project's 

Assistant Manager for Licensing. Any communications between the OR and DOE, its 

contractors, or subcontractors identified in this appendix will not constitute interactions 

within the intent of Section 3 of the base agreement and will not require the preparation 

of written reports or meeting summaries. These meetings are intended to be focused 

discussions of technical topics on site characterization and related activities. At the 

discretion of DOE and NRC, external parties may be notified and invited to observe OR 

meetings and field trips subject to identification requirements and compliance with 

applicable access control measures for security, radiological protection, and personnel 

safety. Communication between the OR and DOE and its contractors and 

subcontractors are not intended to interfere with or replace other channels of NRC/DOE 

communications and procedures for information release identified in the base 

agreement and Appendix 1. 

The following points are agreed to: 

1. The OR can attend any meetings on-site or off-site dealing with technical 

questions or issues related to prelicensing work following notification of the 

cognizant DOE project representative responsible for the meeting as discussed 

below. Such notification shall be by memorandum, telephone or personal 

contact and will be given at least 24 hours in advance where DOE has provided 

adequate prior notification to the OR. The meetings may involve solely DOE or 

solely DOE's contractors (prime and sub), or any combination of DOE with their 

contractors. If objections to the OR attendance are voiced for any reason, the 

reason should be specified. Such objections will be infrequent and will be 

exceptions to the rule. If the OR does not agree with DOE objections, it will be 

raised to a higher management level for resolution. If resolution cannot be 

achieved, the OR will not attend the meeting in question. 

2. The OR may communicate orally (in person or by phone) with persons employed 

by DOE, DOE's prime contractors or the prime's subcontractor, (on-site or off-
16 

site), providing that the following procedures are followed. If practicable, the OR 

will arrange for all individual sessions with prime contractor and subcontractor 

staff by contacting the YMSCO point of contact, or designee. If they cannot be 

contacted, the OR will attempt to contact the proper prime contractor, section, or 

department manager. As a minimum, the OR will give timely notification of all 

such sessions to DOE and the affected contractor or participant(s) management 

as soon as possible. The OR will avoid discussions with personnel when it would 

appear to disrupt important duties and will seek to schedule meetings at a 

mutually convenient time. It is at the option of DOE, in consultation with 

participant management, as to whether or not a staff member, supervisor, or third 

party is to be present. No record of such discussions is required; however, 

questions that are raised or other issues that arise as a result of these 

interactions will be reported by the participant to the YMSCO point of contact, 

or designee. 

When NRC headquarters or contractor staff is temporarily assigned to the OR 

office, the NRC Chief, Performance Assessment and HLW Integration Branch, or 

designee, will notify DOE's Assistant Manager for Licensing of the assignment at 

least one week prior to the assignment. 

3. The DOE project office, DOE prime contractors, and their subcontractors will 

provide the OR access to records which would be generally relevant to a 

potential licensing decision by the Commission as follows. Upon request by the 

OR, DOE or the DOE contractor or subcontractor shall provide: (i) copies of any 

records of data; (ii) records which document the analyses, evaluations, or 

reduction of data; or (iii) records which contain information deduced by reason. 

These records will be made available to the OR, after the documentation has 

been reviewed and approved in accordance with the appropriate project office 

administrative procedure. Records that have not been reviewed and approved 

by the project office shall be made available for viewing, but not to copy or to 

retain, at any stage of completion. Requests by the OR for release of such 

records shall be made through and authorized by the YMSCO point of contact, or 

designee. 

4. Copies of predecisional and preliminary drafts of documents required by the 

Nuclear Waste Policy Act of 1982 as amended, or related to prelicensing 

activities, which have not been approved by DOE, will not be provided to the OR 

without DOE approval. Documents of this type may be made available by 

authorized DOE personnel, for review in DOE or DOE contractor offices. Such 

documents may not be authorized as available by a DOE contractor alone. Any 

such documents made available are for the use of the OR and shall not be 

placed in any NRC public document room. 

5. The OR does not have the authority to direct DOE, its contractors or 

subcontractors to perform any work nor does the OR have stop work authority. 
17 

Any formal identification of questions or issues for investigation by DOE that 

could result in contractor or subcontractor work must be formally presented to 

DOE through the NRC Chief, Performance Assessment and HLW Integration 

Branch in writing. 

6. The OR will attend on-site meetings upon request by the DOE project office or 

prime contractor onsite whenever possible. The OR will provide any records 

which would normally be available under 10 CFR Part 2.790 of the Commission's 

regulations to project participants upon request to copy. If convenient, copies of 

such records will be provided by the OR. 

7. The OR shall be afforded access to the site, research facilities, and other 

contractor and subcontractor areas to observe testing or other data gathering 

activities, in progress, as part of site characterization and related activities 

subject to compliance with the applicable requirements for identification, and 

applicable access control measures for security, radiological protection and 

personnel safety, provided that such access shall not interfere with the activities 

being conducted by DOE or its contractors and that any discussions conducted 

during such access shall comply with Point 2 above. Such access shall be 

allowed as rapidly as it is for DOE or DOE contractor employees upon display of 

an appropriate access identification badge, or, if badging is not possible for 

national security reasons, upon prior notification to DOE or cognizant contractor 

supervisory personnel (by memorandum, telephone, or personal contact). When 

an access identification badge is available to DOE or DOE's contractors and 

subcontractors on a routine basis, it shall be made available to the OR upon 

completion of the required security clearances and appropriate radiological and 

personnel safety training. DOE will ensure that any training required is provided 

to the OR. 

8. NRC can videotape or photograph any inanimate objects or geologic features 

associated with site characterization and related activities at the Yucca Mountain 

Site consistent with Nevada Test Site security. Additionally, upon request from 

the OR, DOE will provide NRC videotape footage of personnel performing site 

characterization and related activities. If requested, the OR and other NRC staff 

will be permitted to accompany DOE during the videotaping. 

9. DOE YMSCO may provide, to the NRC OR, the information required to execute 

DOE responsibilities under Appendix 7 of this agreement by informal note, by 

telephone, or by personal contact. Such communications shall adhere to the 

procedures for communication and information release specified elsewhere in 

this agreement. 

10. Meetings and field trips conducted as described in this section are not to be 

considered as opportunities to establish or alter regulatory positions or 

commitments. No agendas, minutes, or records of these meetings or field trips 
18 

are required. Matters that arise may be (i) reported to YMSCO management by 

the ORs or other NRC representatives assigned to the OR's office through the 

YMSCO points of contact, or designees, or (ii) discussed in internal meeting 

summaries prepared for each organization's management. 

11. Prior notification of external parties, including State, affected units of local 

government, any affected Indian Tribes, or the general public, is not required for 

field trips or meetings under this Appendix. At the discretion of DOE and NRC, 

external parties may be notified and invited to observe OR meetings and field 

trips subject to identification requirements and compliance with applicable access 

control measures for security, radiological protection, and personnel safety. 

12. NMSS may station on-site representatives at any OCRWM project office or work 

site to serve as points of prompt information exchange and consultation. At such 

time as the NRC ORs are stationed at the site, they are to be provided with office 

space that is near the DOE project office and site activities.