Issue Date: 09/11/08 1 2300 

 NRC INSPECTION MANUAL HLWRS 

MANUAL CHAPTER 2300 

YUCCA MOUNTAIN INSPECTION PROGRAM: 

LICENSE APPLICATION REVIEW PERIOD 

2300-01 PURPOSE 

 

To provide policy and guidance for implementation of the U.S. Nuclear Regulatory 

Commission (NRC) Yucca Mountain Project Inspection Program during the period 

between receipt of the U.S. Department of Energy (DOE) license application and 

potential issuance of the construction authorization. 

2300-02 OBJECTIVES 

 

02.01 To evaluate implementation of quality assurance (QA) measures for work being 

performed by DOE during the license application review period that could affect the 

performance of systems, structures, and components (SSCs) important to safety (ITS) 

and engineered barrier systems and natural barriers important to waste isolation (ITWI). 

This would include design, procurement, and fabrication activities and ongoing 

performance confirmation work. 

02.02 To evaluate QA programs of DOE contractors, and DOE’s oversight of its 

contractors, providing services, equipment, and components for long-lead-time ITS and 

ITWI items. This may include inspections at facilities where actual design, fabrication, 

and testing are performed. 

02.03 To maintain an overall awareness of the status of programs and activities 

affecting safety and waste isolation. 

2300-03 DEFINITIONS 

03.01 Contractor. Any organization or individual that is under contract to furnish items 

or services to DOE. This includes, where appropriate, the terms consultant, vendor, 

supplier, and other titled sub-tier organizations. 

03.02 Finding. An observation made during an inspection that has been placed in 

context and assessed for significance. 

03.03 Inspection. An NRC planned and documented activity to investigate, examine, 

or evaluate, through observation or objective evidence, work activities and products to 

determine the adequacy of and compliance with established procedures, instructions, 

drawings, and other applicable documents. 

03.04 Quality Assurance. All those planned and systematic actions necessary to 

provide adequate confidence that a SSC, engineered barrier system, or natural barrier 

will perform satisfactorily in service. 
Issue Date: 09/11/08 2 2300 

03.05 Violation. Failure to comply with any portion of a legally binding regulatory 

requirement, such as a statute, regulation, order, license condition, or technical 

specification. 

2300-04 RESPONSIBILITIES AND AUTHORITIES 

04.01 Director, Division of High Level Waste Repository Safety (HLWRS). Provides 

overall direction for the inspection program. 

04.02 Deputy Director, Licensing and Inspection Directorate (LID), HLWRS.

a. Directs the implementation of policies, programs, and procedures related to the 

inspection program. 

b. Assesses the effectiveness, uniformity, and completeness of implementation of 

the inspection program. 

c. Approves changes to the inspection program. 

04.03 Regional Administrator, Region IV. 

a. Provides program direction for management and implementation of the 

inspection program elements performed by the Region IV office. 

b. Within budget limitations, ensures the regional office staff includes an adequate 

number of inspectors necessary to carry out the portions of the inspection 

program that are within the regional office’s responsibility. 

04.04 Director, Division of Nuclear Material Safety, Region IV.

a. Oversees regional implementation of the inspection program. 

b. Recommends and assists in the development and revision of the inspection 

program. 

2300-05 DISCUSSION 

During the license application review period, the NRC may conduct inspections of 

selected DOE Yucca Mountain Project activities. In addition to performance 

confirmation activities, DOE may proceed with design activities and procurement of 

long-lead-time items prior to NRC reaching a determination on construction 

authorization. Prior to issuance of a construction authorization, there is no regulatory 

requirement for a QA program that meets the requirements of Subpart G of 10 CFR Part 

63. However, DOE is expected to have adequate QA controls in place for activities that 

might affect design or construction of ITS or ITWI SSCs. HLWRS/LID and Region IV 

Repository and Spent Fuel Safety Branch (RSFS) will determine the inspections to be 

performed, and their priorities, based on the activities performed by DOE. The 

inspections will be risk-informed and performance-based to the extent practical. Where 

quality-affecting activities have been contracted by DOE to other organizations, this 

inspection program also applies to those organizations. 
Issue Date: 09/11/08 3 2300 

2300-06 INSPECTION POLICIES AND GUIDANCE 

06.01 Inspection Planning. The Region IV RSFS Branch Chief will schedule the 

inspections and assign the lead inspectors. Scheduling will consider inspection priority 

and the availability of inspection resources. 

06.02 General Inspection Process. For each inspection, the lead inspector should 

implement the process described below for pre-inspection, onsite inspection, and postinspection activities. Applicable inspection procedures provide specific guidance for 

onsite inspection activities. Attachment 1 of this Inspection Manual Chapter (IMC) lists 

certain inspection procedures applicable to this inspection program. Other inspection 

procedures may be developed or used as appropriate. 

a. Pre-inspection activities. To facilitate management of inspection resources and 

tracking of inspection activities, the lead inspector should develop an inspection 

plan. The inspection plan should describe the scope and major areas of 

emphasis that will be inspected. In addition, the inspection plan should identify 

the team members and the inspection schedule. This plan will be reviewed and 

approved by the Region IV RSFS Branch Chief and the HLWRS/LID Project 

Management Branch A Branch Chief. The NRC Office of General Counsel 

(OGC) will review the inspection plan, as appropriate. 

b. Onsite inspection activities. In advance of the inspection, the lead inspector 

should schedule entrance and exit meetings with DOE management or their 

representative, including a representative who has responsibility for the areas to 

be inspected. At the entrance meeting, the lead inspector should discuss the 

inspection scope and other administrative matters, such as interviews with staff 

and document reviews. Whenever possible, the lead inspector should schedule 

a daily status meeting with DOE management to discuss the inspection progress 

and issues identified. 

 The lead inspector should conduct an exit meeting with DOE management at 

the conclusion of the inspection. The lead inspector should determine whether 

their supervisor and HLWRS management should be briefed on the preliminary 

inspection findings prior to the exit meeting. The lead inspector should present 

the results of the inspection, including preliminary findings, emphasizing their 

impact on safety. The lead inspector should make clear to DOE that preliminary 

findings are always subject to management review. 

c. Post-inspection activities. The lead inspector should provide an inspection 

debrief to Region IV management and, as appropriate, will include HLWRS 

management and OGC. Inspection reports should be issued using IMC 0610, 

“Nuclear Material Safety and Safeguard Inspection Reports,” and Region IV 

Policy Guide (PG) 4090, “Inspection Reports,” as guidance. Inspection reports 

should be approved and issued by the Region IV RSFS Branch Chief with 

review by OGC, as appropriate. 

 NRC inspections may identify issues and generic implications that could have a 

bearing on the review of the license application. Relevant inspection findings 

should be presented to appropriate HLWRS management and technical review 

staff for consideration in the review of the licensee application. Issues needing 

additional clarification or resolution may require follow-up inspections. 

06.03 Enforcement Actions. Enforcement actions associated with DOE’s license 

application are not anticipated during the license application review period. However, 
Issue Date: 09/11/08 4 2300 

as an applicant, DOE is subject to applicable NRC regulations regarding Title 10 of the 

Code of Federal Regulations (10 CFR) 63.9, “Employee Protection,” 10 CFR 63.10, 

“Completeness and Accuracy of Information,” and 10 CFR 63.11, “Deliberate 

Misconduct.” If and when the license application (LA) is docketed, DOE will also be 

subject to the regulations regarding 10 CFR Part 21, “Reporting of Defects and 

Noncompliance.” Inspection Procedure (IP) 78010, “10 CFR Part 21 Program,” 

provides guidance for conducting inspections to determine if DOE and its suppliers have 

established a program and procedures to effectively implement 10 CFR Part 21 

requirements for reporting defects and failures to comply associated with a substantial 

safety hazard. Issues identified regarding these regulations may result in violations.

Potential violations identified through inspection activities will be processed in 

accordance with NRC’s Enforcement Policy. 

06.04 Licensing Board Notification. If an issue is identified during the inspection 

debriefs that is new and pertinent to safety and environmental issues (e.g., contentions) 

in ongoing adjudicatory proceedings, Region IV PG 0603 “Procedures for Board 

Notifications Including the Commission,” should be used to make the appropriate 

notifications. OGC should be consulted concerning the need to make notifications 

under PG 0603. 

06.05 Inspector Qualification. NRC inspectors should be assigned responsibility for 

those inspection requirements consistent with their qualifications. All inspections should 

be led by an NRC Inspector certified to IMC 1246, Section XIV, “High-Level Waste 

Repository Inspector.” Support during the inspection may be provided by NRC or 

contracted technical experts. Support personnel are not required to be certified in 

accordance with IMC 1246, but will conduct activities under the lead of a certified 

inspector. 

2300-07 TYPES OF INSPECTIONS 

 

07.01 Data Collection/Analysis Activities. Subpart F of 10 CFR Part 63 requires that 

the performance confirmation program must have started during site characterization 

and continue until permanent closure. During the license application review period, 

data collection and analysis supporting the performance confirmation program, site 

characterization, and other activities such as design qualification testing are expected to 

be ongoing. Inspections may be conducted to assess the implementation of QA 

requirements for data collection and the use of data in analysis and models for work 

being performed. Inspections may include observation of significant ongoing data 

collection activities conducted at the Yucca Mountain site or related Yucca Mountain 

Project facilities. 

Inspections should place emphasis on QA measures, document control, and 

methodologies for ongoing work activities. This includes a review of the methodology 

for data collection, analysis, and evaluation of chemical and physical parameters for 

natural barriers important to waste isolation and to determine environmental conditions 

that may impact engineered features designed for the repository. Inspections should 

include the review of data analysis processes for use of data in modeling, including the 

revision of software codes since the submittal of the LA. This effort should focus on the 

transparency and traceability of data to verify that new data being collected and new 

analyses being performed are properly documented and appropriately selected for use 

in modeling and that modeling software has successfully completed validation and 

verification processes such that model outputs are reliable. 
Issue Date: 09/11/08 5 2300 

Additionally, inspections may review DOE’s oversight of contracted activities to verify 

effective quality measures are being applied to ongoing work. 

07.02 Engineering Design Activities. Selected building and facility design documents 

may be inspected in their early development stages to verify adequate implementation 

of the design process. DOE may proceed with engineering design after LA submittal 

but before a decision is reached on a construction authorization. The objective of these 

inspections is to verify that adequate QA measures have been established and 

implemented for the design of ITS SSCs and ITWI engineered barriers. The inspections 

should evaluate the measures taken to translate applicable regulatory requirements, 

and the design basis described in the license application, into specifications, drawings, 

procedures and instructions. 

07.03 Vendor Activities. When DOE begins procurement of long-lead-time ITS SSCs, 

the NRC may begin inspections to verify implementation of the contractor’s QA program 

and to observe development and testing activities. Potential inspections should be 

determined based on the significance to safety of the SSC provided, the importance of 

the SSC for waste isolation in DOE’s safety analysis, and the overall frequency and 

significance of problems previously identified with the contractor’s SSCs, including 

problems identified by third-party auditing organizations. Inspection emphasis should 

be placed on manufacturing processes, particularly new or state-of-the-art processes, 

employed during the design, fabrication, and testing of basic components. The 

inspections should verify that the contractor’s processes meet applicable industry 

codes, standards and regulatory requirements. The NRC may also observe audits and 

surveillances conducted by DOE of its contractors to assess DOE’s procurement 

process. 

END 

 

Attachments: 

 1. Inspection Procedures 

 2. Revision History for IMC 2300 
Issue Date: 09/11/08 Att1-1 2300 

Attachment 1 – Inspection Procedures 

Inspection Procedure 

Number 

Inspection Procedure Title 

40002 Inspections to Review Allegations 

78010 10 CFR Part 21 Program 

 

 
Issue Date: 09/11/08 Att2-1 

Attachment 2 – Revision History for IMC 2300 

Commitment 

Tracking 

Number 

Issue Date Description of Change Training 

Required 

Training 

Completion 

Date 

Co

Ac

N/A 09/11/08 

CN 08-026 

Initial issuance. IMC 2300 was previously issued and deleted under document name, “Yucca Mountain Pre-operation Inspection Program.” IMC 2300 is being issued to establish policy and guidance for inspections of the Department of Energy’s Yucca Mountain Project activities during the license application. Researched commitments for 4 years and found none. 

None N/A N/A