Ontario Power Generation - Canadian Nuclear Safety Commission Staff Protocol for the Darlington New Nuclear Project Licence To Construct Application

August 2024

Summary of Changes

Revision No.	Date revised	Section	Description of change
0	2021-12-22	All	Revision 0 of the document.
1	2023-02-20	All	Updated to reflect submission of licence to construct application
2	2024-08-23	All	Updated for regulatory engagement and licence application review process

This protocol is strictly administrative in nature. None of the statements in this protocol are to be construed or interpreted as constituting a contract or as affecting the jurisdiction or discretionary powers of the Canadian Nuclear Safety Commission (CNSC) in its assessments of licence applications made in accordance with the Nuclear Safety and Control Act (NSCA).

Nothing in this Protocol fetters the powers, duties, or discretion of CNSC staff or the Commission respecting regulatory decisions or taking regulatory action. Also, this protocol does not change in any way any applicable laws or regulations, application requirements or hearing process as set by the CNSC Rules of Procedure.

The timelines outlined in this protocol provide a transparent and reasonable outline of what may be expected from a regulatory perspective, but do not, and cannot, bind CNSC staff or Ontario Power Generation – Darlington New Nuclear Project (hereto referred to as OPG) in any legally enforceable manner.

This protocol does not, in any way, affect or influence the Commission decision on OPG’s application for a Licence to Construct (LTC).

1. Introduction

1.1. Purpose

Ontario Power Generation (OPG) has a project for the site preparation, construction, operation, decommissioning and abandonment of a new nuclear generating station at its existing Darlington Nuclear Generating Station site located along the north shore of Lake Ontario, in the Municipality of Clarington. The current project scope for Darlington New Nuclear Project (DNNP) is to construct and operate a Small Modular Reactor (SMR) of approximately 300 Megawatt Electric (MWe) as early as 2028.

The environmental assessment (EA) for the DNNP was completed and OPG currently holds Nuclear Power Reactor Site Preparation Licence (PRSL) 18.00/2031. OPG submitted a Licence to Construct application in October 2022. A Commission decision regarding JRP recommendation # 1 was published on April 22, 2024, which states:

“The Commission determines that:

1. Ontario Power Generation Inc.’s selected reactor technology, the General Electric Hitachi BWRX-300 reactor, is not fundamentally different from the reactor technologies assessed in the Environmental Assessment for the Darlington New Nuclear Project; and
2. A new Environmental Assessment is not required.”

A Commission decision regarding the licence to construct application is also required. Recognizing the importance of project schedule and scope, the purpose of this document is to:

• establish a communication process (formal and informal) between OPG and CNSC staff;
• provide a framework within which CNSC staff will perform a technical assessment of the application and supporting documentation to make a recommendation to the Commission on OPG’s application for a Licence to Construct.

Target dates for deliverables and milestones are described in OPG’s LTC Application Plan (NK054-PLAN-01210-00007) and Section 4.2 in this protocol.

This protocol should be followed to allow for open and transparent processes that do not fetter the discretion of the Commission.

1.2. Scope

This protocol will come into effect on the date of the last signature to this protocol. It will terminate on the date that the Commission announces its licensing decision on OPG’s Licence to Construct application.

1.3. Document Security

The CNSC follows the Policy on Government Security, Access to Information Act and Privacy Act for information management. It is important for OPG to classify the submitted documents at the appropriate levels, to ensure that CNSC staff that need it, have access to the information to perform the review. Supporting information provided informally to assist CNSC staff in their review of the Licence to Construct Application has been classified by OPG as confidential.

CNSC will treat this material as confidential per the above noted Policy and Legislation.

1.4. Exchange of information

The exchange of correspondence between OPG and CNSC staff should be effectively coordinated, managed, retained, and retrievable by both participants. The following principles will be applied:

• Formal communication between OPG and CNSC staff will be controlled using the single point of contact (SPOC) approach through the respective Licensing organizations.
• Informal communication, whether verbal or through information sharing will be controlled between OPG, OPG’s contractors and the CNSC using the SPOC approach through both Licensing and technical divisions of each organization. This currently consists of Engineering for the Physical Design, Nuclear Safety for Safety Analysis, Law for Legal aspects and Environment, Health and Safety for Environmental Protection aspects, but may be expanded to other areas, subject to agreement by all three organization.
• The information exchanged will reflect the position of OPG or the CNSC staff – not of the persons involved.
• OPG and CNSC subject matter experts may communicate directly with each other to request clarification or to share information. Licensing SPOC’s must be aware of these communications and involved as required.

There are two types of communication: formal and informal.

1.4.1. Formal Communication

The purpose of formal communication is to document any official regulatory requests or positions from CNSC staff, and for OPG to provide an official response or a formal submission. All formal communication must have a record number associated with it in the corresponding document management systems and captured in action tracking, where appropriate.

1.4.2. Informal Communication

It is a normal and accepted practice that OPG and CNSC staff interact on a regular and informal basis. The basis of this communication is normally to clarify technical points that may relate to administrative, licensing or compliance issues. Neither CNSC staff nor OPG will communicate regulatory positions or application commitments in this manner.

2. Roles and responsibilities

The signatories to this protocol have the following roles and responsibilities:

• The CNSC has regulatory and statutory responsibilities under the Nuclear Safety and Control Act and its regulations. CNSC staff are responsible for assessing OPG’s licence to construct (LTC) application and making a recommendation to the Commission.
• OPG is the applicant and is responsible for submitting adequate and complete information to support the licence application as per regulatory requirements.

For the purposes of this protocol, the CNSC staff shall be represented by the following representatives:

• Director of the Advanced Reactor Licensing Division
• Single Point of Contact, Advanced Reactor Licensing Division

For the purposes of the Protocol, OPG shall be represented by the following representatives: Senior

• Manager, Regulatory Affairs – DNNP Licensing, OPG
• Single Point of Contact, Regulatory Affairs – DNNP Licensing, OPG

CNSC staff and OPG will identify an alternate if a primary team member is unavailable.

For the purposes of LTC communication as per this protocol, GEH shall be represented by the following representatives:

• Manager, Canadian Product Regulatory Affairs, GEH
• BWRX-300 Chief Nuclear Engineer, GEH

3. Long lead items

Long lead items may include technical or regulatory reviews of structures, systems, components, programs and/or processes. Upon request, CNSC staff will review OPG submissions for long lead items and provide a technical review, identifying any potential barriers to licensing or providing concurrence on OPG’s methodology and/or approach. It is understood that CNSC staff positions on such items does not and cannot, in any way, bind Commission decisions and that procurement of such items is entirely at the business risk of OPG. The authority to approve or accept long lead items lies with the Commission as part of its decision-making processes.

4. Application work

CNSC staff will review the application for a LTC, in accordance with REGDOC-1.1.2, Licence Application Guide: Guide to Construct a Reactor Facility, version 2. Further review criteria are captured in CNSC regulatory and guidance documents and in industry codes and standards applicable to a construction licence.

4.1. Project schedule

OPG will provide CNSC staff with a project schedule with an overview of the completion of the project, as well as more detailed schedules on components of the project or information that will be required to enable, or are tied to, the accomplishment of scheduled activities.

OPG will update the schedule regularly and will notify CNSC staff of any significant changes in the schedule that are related to the items identified by CNSC staff upon such changes being identified.

4.2. Application Review Time

CNSC staff’s review process began when OPG submitted its initial application for a LTC in October 2022. OPG will endeavor to support an expedited licensing process with an anticipated CNSC staff review time of 24 months, and an expeditious record of decision by the Commission. REGDOC-3.5.1, Information Dissemination: Licensing Process for Class I Nuclear Facilities and Uranium Mines and Mills, Version 2, identifies a 32-month timeline for Class 1A nuclear facilities. This timeline includes the application review, preparation of the Commission Member Document and the hearing process.

The 24-month review period is based on the assumption that the information submitted by OPG is sufficiently complete and detailed to allow the regulatory safety assessment and licensing process to proceed efficiently. CNSC staff will endeavor to review the application expeditiously without compromise to the level of effort required to ensure a thorough technical review. CNSC staff also will not compromise on timelines for engagement and consultation with the public and Indigenous groups.

The planned review time may be extended under various circumstances including, but not limited to:

• any significant changes made to the design or safety analysis of the nuclear power plant;
• any delay in OPG’s timelines for submitting packages;
• the insufficiency of the information provided by OPG. For an expeditious review, the submissions must be complete, comprehensive and of sufficient quality to ensure the review can be carried out in an efficient manner;
• resolution of information requests issued by CNSC staff;
• any outstanding issues from compliance under Licence to Prepare Site that impact the assessment of the LTC application;
• any additional time to ensure adequate public and Indigenous engagement and consultation.

In circumstance’s where review timelines may be delayed:

• OPG and CNSC staff will communicate review timelines delays to the other as soon as they are reasonably able to;
• CNSC staff will continue reviewing material in other submission packages where possible; and
• OPG and CNSC staff will provide updated estimated timelines for the completion of applicable work and resolutions.

OPG has committed to providing responses to LTC application technical review information requests in 40 business days. CNSC staff has committed to providing a response on the sufficiency of OPG’s response in 20 business day. Going forward both parties will, within 10 business days of receiving a correspondence, provide a written confirmation of its review and a firm timeline for any responses or completion of request. For any items identified as “Prior Notification” OPG will provide the submission 30 days in advance of implementation, unless an alternate timeline for acceptance or approval has been noted.

As separate plan with a detailed list will be created for tracking of OPG DNNP commitments, submissions and closure milestones. Any timelines committed by either party will be tracked in this plan.

OPG will notify CNSC staff as early as possible if slippages occur in the schedule of submissions. CNSC staff will attempt to accommodate slippages to the extent practicable.

CNSC staff’s assessment consists of a technical review on the LTC application packages (see Table 1 below).

Table 1 - Detailed technical review LTC application packages

Package	Topic
1	Management Aspects
2(a)(b)	Design and Safety Analysis
3	Security
4	Environmental Monitoring and Environmental Assessment (EA) Follow-up
5(a)(b)	Core Control Processes and Operations Aspects
6(a)(b)	Construction and Commissioning Program

The grouping of submissions will be as follows:

1. LTC Application was submitted with packages 1, 2(a), 2(b) and 3 on October 31, 2022.
2. Package 4 was submitted on November 17, 2022
3. Packages 5(a), 5(b), 6(a) and 6(b) were submitted by March 31, 2023.

4.3. Results of the Technical Review

During the technical review, CNSC staff will issue an information request (IR) if it is determined that there is insufficient information available to complete the review. Upon completion of the detailed technical reviews to satisfy each Safety and Control Area, CNSC staff will confirm the closure of any information requests.

OPG may propose submission of responses to information requests and other technical comments later in the licensing lifecycle. CNSC staff will review the proposed deliverable and deliverable date or milestone and indicate its concurrence with the proposal as “conditional acceptance”. All such conditional acceptances that have deliverable dates or milestones occurring within the period of the construction licence shall be tracked by OPG in its quarterly commitment report as outlined in section 4.8 of this protocol.

Once IRs are closed and finalized, the document title will be made available on the CNSC Open Governmental Portal, subject to redaction of OPG proprietary or confidential information.

4.4. Issue Resolution

CNSC staff will review the Licence to Construct application submitted by OPG to make licensing recommendations to the Commission. Disagreements between OPG and CNSC staff raised during the review, including differences of opinion or interpretation and application of regulatory documents, will be addressed under issue resolution mechanism.

Nothing in this issue resolution mechanism seeks to bind, or has the effect of binding, the Commission.

Step 1: Identification of the Issue and Resolution at the Project Manager/Working Level

1. Periodic OPG and CNSC licensing or technical review meetings will be held to review progress on the key activities and highlight any potential major issues. Minimum attendance at these review meetings will be the Licensing SPOC for CNSC staff and OPG but may include technical SPOCs as well. For the Physical Design, Safety Analysis, and Environmental Protection safety and control areas, informal technical meetings may be initiated by OPG’s and GEH’s Design Authorities and respective managers with CNSC Division Directors. OPG and GEH Licensing will be in attendance during all such meetings with CNSC.
2. The intent is to identify any potential major issues either through these licensing and technical review meetings or through outstanding CNSC staff’s LTC review technical comments. Where all technical comments associated with a Safety and Control Area or a specific subject have been resolved, CNSC staff will confirm resolution of that area and the item will be considered closed for the purposes of the LTC application review and recommendation.
3. It is the intention of all participants to resolve issues at this level.
4. If an issue cannot be resolved at this level, it will be documented (typically, a brief factual summary of the issue and a paragraph representing the view of each organization) within one week of the indecision and forwarded to the Director/Manager Level (Step 2).

Step 2: Resolution at the Director/ Manager Level

1. A Step 1 issue, once documented, will be provided to the CNSC Director of the Advanced Reactor Licensing Division and OPG Senior Manager, Regulatory Affairs – DNNP Licensing. A meeting will be called, normally within 7 business days, to resolve the issue, and the resolution documented.
2. Issues which cannot be resolved at this level will be referred to the Executive Level (Step 3) within 10 business days, supported by the original or revised documentation from Step 1 and any additional documentation from Step 2.

Step 3: Resolution at the Executive Level

1. A Step 2 issue with documentation will be sent to the CNSC Director General, Directorate of Advanced Reactor Technologies and OPG Director and VP, Nuclear Regulatory Affairs. A meeting will be called, normally within 30 days, to resolve the issue and the resolution documented. In exceptional circumstances, CNSC Executive Vice President & Chief Regulatory Operations Officer and OPG Sr Vice President – Enterprise Engineering and Chief Nuclear Engineer will resolve issues that remain outstanding from Step 3. If the issue cannot be resolved at CNSC staff level, the issue will be presented to the Commission for decision as part of the licensing process.

Key OPG points of contact for the regulatory engagement with the CNSC are:

VP, Nuclear Regulatory Affairs Director,
Regulatory Affairs Strategy
Senior Manager, Regulatory Affairs DNNP Senior
Advisor Licensing
Director, Engineering
Senior Manager, Design Engineering Senior
Manager, Engineering Programs Senior
Manager, Safety Analysis
Senior Manager, Environment Health and Safety
Senior Counsel

Key GEH points of contact for the regulatory engagement with the CNSC are:

VP, New Plant Licensing
Manager, Canadian Product Regulatory Affairs
BWRX-300 Chief Nuclear Engineer

4.5. Managing change

When a proposed change to the licensing basis is considered risk significant and has a potential impact on the review of OPG’s licence to construct application itself, the change will be submitted to the CNSC as a formal notification. Any changes to the LTC application and/or supporting documents that have a potential impact on the design and safety and control measures contained within the application, will be communicated as “notification requiring CNSC concurrence as per the OPGs standard process, as these changes may impact the conclusions of CNSC technical review. Changes will be communicated on a quarterly basis. OPG started this process after the submission of the last LTC application package with the first quarterly notification having been submitted for Q2 2023.

4.6. Interfacing with other Jurisdictions

OPG and CNSC staff will identify areas of coordination with various jurisdictions in the federal, provincial, and municipal level. Where possible, CNSC staff will provide a single window approach to coordination of review efforts in its role as the regulator.

4.7. Project Communications

Monthly or more frequent meetings will be held between OPG and CNSC staff at the project management team level to discuss the review progress and highlight any potential major issues.

On a quarterly basis or more frequently, manager level meetings will be held between OPG and CNSC staff to discuss the overall progress for the project and any issues as required.

4.8. Licence to Construct Commitments

There are a number of regulatory commitments related to the DNNP, as specified in the DNNP Commitments Report (NK054-REP-01210-00078). These activities, and deliverables associated with these regulatory commitments, must be completed as part of the Licence to Construct Application. OPG will make submissions for these regulatory commitments as per the DNNP Commitments Report. In addition, any other formal regulatory commitments made by OPG as part of the CNSC LTC review process are captured in regulatory actions, the status of which is reported to CNSC staff on a quarterly basis.

4.9. Document Approval

Documents formally submitted in support of the application will be approved or accepted by the applicant in accordance with OPG’s governance procedure N-PROC-MP-0078.

At the time of licence to construct application, the design has not been finalized. Accordingly, some technical documents, including those produced by the design authority, may be provided as in-progress design information to facilitate the technical assessment. These preliminary design documents are reviewed by OPG using a graded approach and will be formally accepted at the end of design phases BL2 and BL3 as per governance procedure NK054-PLAN-01210-00035 These documents will be secured in the same manner as formally approved documents as stipulated in section 1.3 of this protocol. Notification of changes to formally submitted LTC application documents will be managed via OPG program N-PROG-RA-0002 through the submission of subsequent baseline design information or as part of the quarterly notification process as stipulated in section 4.8 of this protocol. This does not include changes to submitted in-progress design documents.

5. Revisions of the protocol

Significant material revisions of this protocol shall be coordinated by the managers and approved by the signatories of this protocol. Managers can approve minor revisions (e.g., editorial corrections, clarification of text or updates to organizational structure) to this protocol.

6. Approval by signatories

The participants hereto have signed the protocol, in counterpart, on the dates indicated below.

Mark Knutson
Sr. Vice-President – Chief Enterprise Engineer and Chief Nuclear Engineer, Ontario Power Generation Inc.

Ramzi Jammal
Executive Vice-President and Chief Regulatory Operations Officer Canadian Nuclear Safety Commission

7. References

Canadian Nuclear Safety Commission Rules of Procedure, SOR/2000-211.