Convention on Nuclear Safety (CNS) Questions and Answers for Canada for Joint 8^th & 9^th Review Meeting

1. How was staff motivation maintained during the limitations imposed by the COVID pandemic?

2. Is there an effective knowledge management plan for different generations of workers?

The response is provided in the context of CNSC.

1.Shortly after the pandemic started, the CNSC began conducting regular pulse surveys to assess employee engagement and satisfaction on key workplace and health issues. The results provide managers with insights into areas that employees may be struggling with (e.g., workload pressures, balancing work and home life) in order to address situations and support employees as required. In addition, the CNSC conducts regular (quarterly) virtual Town Hall meetings where Executive Team members hold an “Ask Me Anything” segment. Employees can submit questions anonymously if preferred, and the utilization of tools allows for questions with the most votes to be responded to first.

The CNSC is a strong supporter of health and wellness, providing ongoing resources to employees through LifeSpeak - a health and well-being platform that includes videos, podcasts, tip sheets and “Ask an Expert” sessions on general topics related to mental health and well-being. This service is completely anonymous.

Recognizing that employees are motivated in a variety of ways, the CNSC also has a robust awards and recognition program to formally reward employees for key accomplishments.

2.The CNSC course Effective Knowledge Transfer, offered internally to all employees, discusses types of knowledge, such as tacit and explicit knowledge, barriers to knowledge transfer, adult learning principles and tools and strategies for effective transfer. In addition, the CNSC has several tools to support knowledge transfer, including checklists on identifying knowledge, guides on managing organizational memories and guidelines for assessing attrition risks. The CNSC also has a pre-retirement transition program that provides employees an opportunity to slowly reduce their working hours (i.e., 4 days a week, 3 days a week) to support their transition to retirement while they conduct knowledge transfer.

Page 13 Section D.2 Life extension of existing NPPs states that life extension activities are identified through a PSR and documented in an integrated implementation plan (IIP).

1. What are the dominant documents considered for decision-making for the renewal of a licence?

2. How does Canada calculate the remaining lifetime of structures, systems, and components (SSCs) to estimate the operating lifetime of the reactor?

(1) The dominant document considered for the licence renewal is the licence application that is submitted by the licensee to the Commission, formally substantiating and requesting licence renewal. There are a number of other licensee documents that support the application, and these include the PSR-related documents such as the global assessment report and the IIP, as well as the environmental risk assessment and the licensee’s program governance documents under its nuclear management system. In addition to the licensing documents provided by the licensee, other documents that are an important part of the CNSC’s decision-making process for licence renewal include submissions made by intervenors via the public consultation process as well as Commission Member Documents submitted by CNSC staff on their evaluation and recommendations for the licence renewal request.

(2) In Canada, all licensees have aging management programs to monitor the remaining lifetime of the SSCs. Through asset management programs, licensees have developed asset life projections and options that lead to asset management options templates (AMOTs). AMOTs have been used to assess the remaining life for all SSCs in the NPPs and have developed life management options which could entail on-going inspection and maintenance, refurbishment or replacement options. Any life extension requires re-assessment of the SSCs through system and component condition assessments as well as an update to the PSR and supporting documents. Note that pressure tubes are the life limiting component for CANDU reactors; however, they are replaceable, which potentially allows for multiple life extensions.

Executive summary

Page ii, 24

There have not been any substantial challenges in dealing with the gaps identified in the PSR. However, a part of the process is to determine which improvements can practicably be made. There are cases where the licensees have asserted that some improvements are not practicable, such as either due to physical limitations or through cost-benefit analysis. These assertions are reviewed by the CNSC to ensure that reasonable justification has been provided and obtain agreement that the gap does not need to be addressed, through the approval of the IIP.

There has not been any challenge on providing a conclusion for continued operation. This is not unexpected, however, as the purpose of the PSR is to review a plant that has already met safety requirements and look for improvements based on more modern standards.

Safety Factor Reports 1-4 were the ones that directly led to modifications being made in the NPPs as they focused on design, condition of SSCs, environmental qualification, and aging. In the most recent round of PSRs in Canada, the codes and standards that adopted post-Fukushima requirements have led to significant safety upgrades, such as enhanced overpressure protection and containment filtered venting. Note that while these improvements were included in the PSRs for completeness, they were also addressed separately through the integrated action plans that addressed directly the lessons learned from the Fukushima Daiichi accident.

Consultation with the public, Indigenous Nations and communities, licensees and interested organizations is an important part of the process the CNSC uses to develop many of the regulatory tools within its regulatory framework. The CNSC welcomes input on discussion papers and draft documents, and on proposed new regulations or amendments to regulations.

Each document is made available for public comment for a specified period. Comments submitted, including names and affiliations, are posted in the official language in which they were received. At the end of the consultation period, CNSC staff review all input and prepare a consultation report to summarize the feedback.

In addition, the CNSC often hosts consultation workshops with interested parties.

In 2020 and 2021, the CNSC reviewed the readiness of the regulatory framework to regulate disruptive, innovative and emerging technology (DIET). The review consisted of a series of questions that were applied against each section of each regulatory instrument in the framework:

• Does the text reference specific methodologies/ technologies?
• Is the language prescriptive regarding the manner in which something will be achieved?
• Could the text limit the opportunity for new technology?
• Are there opportunities for adding DIET-neutral text?

It was concluded that the CNSC regulatory framework does not impede the introduction of DIET. The overall finding was that the framework is predominantly “technology neutral”. While there are a few documents that are in part "CANDU-centric", it is with reason. The results of CNSC's review aligned with the findings of an external (Kinectrics) regulatory framework review for fusion (a DIET technology, which was completed in 2022 and confirmed the CNSC finding that the framework is ready to regulate fusion.

In short, the CNSC’s approach of regulating nuclear activities with a generally performance-based approach facilitates the safe introduction of DIET into regulated activities.

The graded approach is a method or process by which elements such as the level of analysis, the depth of documentation and the scope of actions necessary to comply with requirements are commensurate with the following:

1. the relative risks to health, safety, security, the environment, and the implementation of international obligations to which Canada has agreed

2. the characteristics of a facility or activity

The Commission and CNSC staff apply a risk-informed approach to all safety and control areas (SCAs) in order to place an appropriate amount of regulatory scrutiny on activities, depending on the level of risk. Primary considerations for the extent and depth of application are the degree of novelty, complexity and potential harm posed by the proposed activity or facility.

Understanding risks, including associated uncertainties, and ensuring that these risks are mitigated also plays a significant role in making regulatory recommendations and decisions. The risks and mitigation approaches need to be clearly described and well understood in order for the Commission to make an informed decision. Supporting evidence and the quality of that evidence are critical. Supporting evidence may include results of R&D, computer modelling and consideration of operating experience, and the evidence must be demonstrated to be relevant to the specific proposal.

When the Commission assesses applications that reflect a graded approach, its primary consideration is to ensure that risk is demonstrated to be at a reasonable level. This includes ensuring that:

1. regulatory requirements will be met

2. fundamental safety functions are adequate

3. high-level safety objectives are met

4. defence in depth is adequate

5. safety margins are appropriate and in line with specific hazards over the facility’s lifecycle

The national report states “Following the discovery of elevated measurements of equivalent hydrogen in pressure tube scrape samples at Bruce Units 3 and 6, CNSC issued an order to Bruce Power to obtain authorization from the commission prior to the restart of any of Units 3, 4, 5, 7 or 8 following any outage that results in a cooldown of the heat transport system.”

Since hydrogen near the burnish mark was found to be more than expected, could Canada indicate whether the accelerated increase of hydrogen was observed after a certain period of operation?

(1) According to page 36 and Annex 7.2(i)(a), the CNSC's regulation-making process includes extensive consultations with both internal and external stakeholders. How are the roles of internal stakeholders and those of external stakeholders distinguished in the drafting stage?

(2) Is there a set interval for the review of existing standards and documents in the regulation-making process?

When conducting analysis of any regulatory instrument within the CNSC’s framework, a working group comprising technical specialists and policy analysts review the subject matter and consider all standards (not only those developed by CSA and IAEA) to provide regulatory guidance and best practices to ensure the safe and secure operation of all licensed activities. Recommendations from this working group are considered by CNSC management for the standard(s) inclusion in the framework.

Regulated communities are provided the opportunity to comment on the inclusion of standards in the framework throughout the analysis and development phases of CNSC REGDOCs and regulations. This is performed through workshops, discussion papers, invitations to comment on draft documents, and other outreach activities.

According to page 46 of your national report, pre-licensing vendor design reviews (VDRs) are performed on reactor designs to identify and resolve potential regulatory or technical issues early on during the process of design.

(1) Please share two cases where issues were identified in the VDR process and how they were resolved.

(2) How do you implement VDR with the current licensing standards as it would be difficult to do pre-licensing review with the current licensing standards?

(3) How do you address the gap between the technical standards in the VDR stage and the current technical standards applied to licensing?

(4) In terms of permit procedure, period and review process, what are the differences between pre-licensing VDR and current processes for construction/operating permits?

(5) When pre-licensing VDR is complete, what future effects does VDR have? For example, how does VDR affect the process for an operating licence later? That is, if VDR is conducted, will the relevant area be left out of the review in the licensing process for the operating licence?

(1) Due to the confidentiality of proprietary information under review as part of the VDR, CNSC is unable to disclose the technical issues and resolution of specific designs, however, we can speak to it in general terms.

a. Means of shutdown (MOS) design: The design of MOS that is acceptable in a vendor’s host country is not necessarily acceptable withing the CNSC regulatory framework. This includes designs where the diverse means of shutdown credited the use of two diverse actuation systems that use the same rods. In these instances based on CNSC review during the VDR, the vendors either added another independent and diverse MOS or committed to provide additional justification to demonstrate safety that is equal to, or exceeds, Canadian requirements.

b. Event classification: A number of vendors used an event classification scheme to identify design basis accidents (DBAs) that was not aligned with the CNSC requirements (i.e., the frequency thresholds used differ from that used in Canada). Through the VDR process, the vendor committed to revise the classification scheme to align with CNSC requirements.

(2) The CNSC’s regulatory framework is robust and flexible and is fit for the pre-licensing review of advanced reactors and SMRs. As part of its regulatory framework, the CNSC permits the application of alternative approaches which have been exercised by vendors when submitting novel designs. The CNSC reviews the submissions against existing guidance and available research, while exercising engineering judgement. Internal processes and committees for addressing novel alternative approaches have been created to ensure a systematic, whole-of-organization perspective.

(3) A licence applicant must ensure their design meets the most up-to-date regulatory requirements at the time of licensing. The proponent is responsible for ensuring that they are kept aware of how the changes of standards impact their design. A freeze date is applied on standards once the licensing process has started to prevent changing expectations during an ongoing review.

(4) The VDR review process is documented in CNSC REGDOC-3.5.4, whereas the licensing processes are governed by the Nuclear Safety and Control Act (NSCA) and its regulations and documented in REGDOCs-1.1.1, 1.1.2, and 1.1.3 for site preparation, construction, and operation licences, respectively. Both sets of processes involve the applicant submitting information according to an agreed timeline, with CNSC staff performing the review, and holding a series of discussions. A major difference is that there is no licensing decision at the end of a VDR, and no public hearing process, which is required in the licensing process. The depth of licensing review is more comprehensive and covers all CNSC SCAs, while the VDR focuses on 19 select topics of interest. The timelines differ accordingly with VDRs spanning 1-3 years depending on the phase of review, and licensing covering several years, depending on the type of licence.

(5) The review does not certify a reactor design and does not involve the issuance of a licence under the NSCA. It is not required as part of the licensing process for a new reactor facility. The conclusions of a VDR do not bind or otherwise influence decisions made by the Commission, with whom the authority resides to issue licences for nuclear reactor facilities. The conduct of a VDR supports the vendor in identifying areas where improvement is required to facilitate the smooth conduct of a licensing review. During the course of a licensing process, the CNSC will be able to consider the results of a previously conducted VDR to inform their position and expedite the review of a certain area, if the information is still relevant.

The development of regulatory requirements in Canada involves significant consultation. Prescriptive requirements require significant consultation to confirm that the details are appropriate and achieve the desired effect. However, performance-based, as well as non-prescriptive requirements, which may only identify the desired effect, involve similar consultation; the impacted parties would still need to consider how the variety of detailed options available can satisfy the required performance level, which could be quite generalized. So, development of performance-based requirements is not necessarily easier or more difficult than the development of prescriptive requirements. Once in place, both prescriptive and performance-based requirements necessitate that CNSC verify applicants' and licensees' compliance by examining details. From the perspective of applicants and licensees, performance-based requirements offer greater flexibility, but at the same time less certainty that their proposed, detailed measures will be confirmed by CNSC to meet the performance standard.

In Canada, the approaches taken to develop, meet, and confirm performance-based requirements have evolved gradually, with CNSC, applicants, and licensees adapting and improving over time. At the same time, detailed or prescriptive requirements have been introduced where needed. The result is the ongoing, strong safety record that is described in the report.

"For a licence amendment, suspension, or revocation, the licensee would normally receive advance notice and have an opportunity to be heard by the Commission."

In the case when a licence is revoked, does the CNSC have any measures in place to assign responsibilities and to ensure the safe operation of the facilities?

Before a licence is revoked, the CNSC must grant the licensee a reasonable opportunity to be heard, during which the CNSC can determine if measures are in place to ensure continued safe operation. In the case of a licence revocation, the decision-maker will be the Commission itself (as opposed to a designated officer) because only the Commission can revoke a licence on its own motion. CNSC Staff will also provide the decision-maker with their assessment of the safety, security, and environmental implications of revoking the licence (and/or of not revoking the licence). In the case of a licence revocation in which the licensee declines to exercise their opportunity to be heard, CNSC staff will still provide the decision-maker with this assessment. CNSC staff’s submissions will also include its recommendations for the decision-maker’s consideration.

If necessary, CNSC staff can take regulatory action to ensure the continued safe operation of the facility; CNSC inspectors and designated officers are authorized by the NSCA to order licensees to take any measures necessary to protect the environment, health, safety, or security. They may also order any person (i.e., non-licensee) to take certain actions that the inspector or designated officer considers necessary for certain specified purposes, for example: decontaminating a place or vehicle, storing a nuclear substance so as not to cause an unreasonable risk, or putting a nuclear facility into a safe state. Any person so ordered would be required by law to comply with the order, until an opportunity to be heard prior to the order being confirmed, amended, revoked or replaced. Compliance would include paying any necessary costs of compliance, though ultimately, they might be able to recover payment for the cost of compliance against others (such as former licensees) through a civil action.

"Each NPP site with a licence has an associated licence conditions handbook (LCH), the contents of which are under the responsibility of CNSC staff. A licensing hearing before the Commission always includes a proposed LCH for the Commission to review. LCHs are organized by the licence conditions and hence by the CNSC SCAs. Intended to inform both the licensee and CNSC staff, the LCH gathers in a single document all the regulatory details, explanations, expectations and associated processes for definitions, interpretations and administrative control of the licence conditions. The LCH is read in conjunction with the licence. The LCH associates each licence condition with compliance verification criteria (CVC) that are used by CNSC staff to confirm the licensee’s compliance with the licence condition."

Are the LCHs updated on a regular basis to accommodate changes (e.g., changes to the licence conditions, changes in the CSNC's expectations or understanding of a problem, etc.)? How does the CNSC ensure that updates to the LCH are communicated to the licensee?

Are the CVC made available to the licensee as well?

LCHs are not updated on a specific timeframe, but can be updated at any time, as needed. Typically, an LCH is not updated more than 1 time every 6-10 months. An update will typically include a number of revisions that have been tracked over that time period. Revisions may include changes to expectations such as new requirements as CVC (e.g., the implementation of new regulatory documents and standards) and new guidance documents. Revisions may also capture changes in regulations, licensing basis documentation or additional information related to the understanding of a specific problem. Changes to a licence condition may only be made by the Commission through a licence amendment; if that happens, the LCH would reflect, as appropriate, the change to the licence condition.

When an LCH is being revised, a draft is typically shared with the licensee to provide an opportunity to raise any potential issues with the CNSC. The licensees have no control over the revision of the LCH itself but sharing a draft helps ensure there are no errors, surprises (that could result in unintentionally putting a licensee in non-compliance), or unforeseen consequences in the revision.

All CVC are available to the licensees, since CNSC give a copy of the LCH to the licensee, including any revision. Licensees, as well as any member of the public, may also request a copy of the LCH at any time.

"Licence renewal is a mechanism for implementing new requirements from recently published CNSC REGDOCs or standards, thus contributing to the continuous safety improvement of NPPs."

Could you elaborate on the methodology used to introduce new requirements on the licence conditions? In other words, when does the CNSC decide to amend the licence conditions to introduce new requirements like REGDOCs, and when does the CNSC wait until a new licence is issued to introduce new requirements? Could the CNSC elaborate on the best approach to introduce new requirements based on its own experience?

The response to Question ID 32618 explains how licensees may be recommended or requested to implement recently-published or revised CSA standards; the same description would apply to CNSC REGDOCs. In Canada's experience, the practice of requesting implementation plans for new REGDOCs or standards, when warranted, has been effective in upgrading licensees' safety and control measures in a timely and appropriate manner, considering costs, other developments, etc. Continuous improvement is an essential tenet for both the licensees and the CNSC.

Licence renewal remains an effective mechanism to drive the implementation of new REGDOCs or standards that were not implemented by the licensee during the licence period. It is rare for the licence to be amended, during the licence period, to reflect the implementation of a new REGDOC or standard. The licence conditions themselves are brief and general, and typically do not cite specific REGDOCs or standards (e.g., there is a licence condition "The licensee shall implement and maintain a safety analysis program."). Licence amendments, when they do occur, typically change specific content in a licence condition (e.g., to adjust to a change in the licensed activities).

"The licensees of operating NPPs also conduct periodic safety reviews (PSRs) in support of ongoing operation, which also account for the possible implementation of new requirements associated with modern codes, standards and practices."

"In the previous reporting period, CNSC staff began recommending 10-year operating licences for NPPs, with a PSR performed every 10 years to synchronize with licence renewal. In 2017, the CNSC amended the Class I Nuclear Facilities Regulations to require all NPPs to conduct a PSR at an interval specified in the licence."

Could the CNSC specify how often PSRs are, or will be, conducted? What is the basis for the CNSC's decision regarding the period to be imposed in the licence conditions?

PSR involves, among other things, the identification of the applicable modern codes, standards and practices against which the NPP will be assessed. PSR also involves an examination of 15 safety factors (the 14 safety factors identified in IAEA SSG-25, as well as radiation protection). The IIP that results from the assessment will identify practicable safety improvements over time - such improvements will bring the licensed activity in closer alignment with the modern requirements but will not necessarily involve the full implementation of all requirements in a new REGDOC or standard. Also, some CNSC SCAs are not fully covered by the list of PSR safety factors, e.g., nuclear security. Thus, implementation of modern requirements related to security must be addressed by a mechanism other than PSR.

Full implementation of new REGDOCs or standards is a preoccupation of licensing. For example, licence renewals will involve the identification of REGDOCs and standards for the applicant to address in its application. The Commission effectively accepts the safety and control measures described in the application, including any proposed plans for implementing new REGDOCs or standards, when it renews the licence. Any REGDOCs and standard already implemented, and any plans to implement new ones, become part of the licensing basis for that licence.

The list of REGDOCs and standards that form the licensing basis (including ones to be implemented during the licence period) will typically not match the list of REGDOCs and standards considered in the PSR. For example, the PSR may consider a REGDOC intended primarily for new-build that can never be fully implemented at an existing NPP. In a similar example, it may be too early for a licensee to determine when a new REGDOC can be fully implemented, but it may be possible for a licensee in the context of PSR to assess and address some gaps with the new requirements in the new REGDOC. Also, the lists of REGDOCs and standards to be considered in a PSR and in a licence renewal application are developed at different times, so the most recent publications may not be addressed in either or both.

Nevertheless, after the PSR is complete and the licence is issued, CNSC may still (and does) request licensees to implement new REGDOCs and standards during the licence period. The details of implementation (e.g., date of full implementation) that were provided in the licence application, as well during the subsequent licence period, are reflected in the LCH as CVC.

This response is provided in the context of the question, which focuses on the implementation of new REGDOCs and standards. Typically, the LCH records, as CVC, the general plans that a licensee has provided for the implementation of a new REGDOC or standard. At the very least, this would include a date by which the licensee has indicated that full implementation will be complete. It could also include interim dates (major milestones) or planned significant changes to key licensee safety and control measures. CNSC staff may verify any of these, but typically an inspection against the new requirements would not occur until after the declared date of implementation.

A failure to implement the new requirements by the indicated date would be recognized as a non-compliance. Similarly, a failure to meet one or more of the new requirements, as determined by, say, an inspection after the licensee has indicated that implementation is complete, would also constitute a non-compliance.

As noted in Article 7.2 (iv), an AMP is one of a number of enforcement options that could be used to address the non-compliance, depending on its seriousness. The amount of an AMP depends on:

(a) the compliance history of the person who committed the violation;

(b) the degree of intention or negligence on the part of the person;

(c) the harm that resulted or could have resulted from the violation;

(d) whether the person derived any competitive or economic benefit from the violation;

(e) whether the person made reasonable efforts to mitigate or reverse the violation’s effects;

(f) whether the person provided all reasonable assistance to the Commission; and

(g) whether the person brought the violation to the attention of the Commission.

For existing NPPs, it is rare that a new REGDOC or standard addresses a significant gap - most are simply improvements on existing practice. AMPs are very rare for NPP licensees and would not be used to address the type of situation covered in this question. A failure to implement, in whole or in part, a new REGDOC or standard is more likely to be addressed through discussions with the licensee to determine the immediate safety concern, if any, and the extent of any compensating measures planned in the interim. Other enforcement measures, such as written notices or increased regulatory scrutiny, as described in Article 7.2 (iv), may be better suited to address these types of situations.

The baseline compliance verification plan for NPPs is based on establishing a minimum set of compliance verification activities to assure a sufficient level of sampling across all SCAs over a defined five-year period for an operating NPP with a standardized power reactor operating licence. Baseline compliance activities are not limited to inspections as CNSC staff may utilize other means of verifying compliance such as event reporting, scheduled reports and compliance assessments. To assure a sufficient level of sampling, all SCAs and their subset areas have at least one planned baseline activity performed on a yearly basis that can be reported back to the Commission and the public.

On top of that, CNSC staff utilized a risk-informed approach to assess the weighted relative risk of each SCA. SCAs were assigned a greater number of compliance activities based on their relative risk to provide a greater level of oversight to assure confidence of the licensees’ continued safety performance. As an example, for the management system SCA, about four compliance activities are planned on the baseline versus packaging and transport, which has one activity planned per year. Regardless of the number of planned activities, CNSC staff also plan for supplementary, or initiate reactive, compliance verification activities as necessary to respond to emergent trends, circumstances, and events.

The CNSC’s regulatory framework is robust and flexible and is fit for the pre-licensing review of advanced reactors and SMRs. As part of its regulatory framework, the CNSC permits the application of alternative approaches, which have been exercised by vendors when submitting novel designs. The CNSC reviews the submissions against existing guidance and available research and exercises engineering judgement. Internal processes and committees for addressing novel alternative approaches have been created to ensure a systematic, whole of organization perspective.

As part of its continuous improvement process, the CNSC is evaluating further enhancement to its regulatory framework to ensure that new technologies are properly regulated. For example, the security regulations are being updated to better address SMR challenges.

It is mentioned that there is a CNSC long-term regulatory framework plan for the period from 2019 to 2024, which outlines the regulations and regulatory documents that the CNSC will be developing or amending during that time.

Is this plan revised and updated on an annual basis and does it include the responsible persons, resources, supervision, etc.?

The CNSC follows the Cabinet Directive on Regulation and the associate Treasury Board Directives on Regulatory Transparency and Accountability. As a regulator in Canada, the CNSC is required to publish on its external website its forward regulatory plan and update its regulatory stock review by April 1st annually. This gives advance notice of upcoming regulatory changes over a period of 24 months and also long-term regulatory projects.

These updates are based on the CNSC 5-year regulatory framework plan. The regulatory plan is reviewed and approved annually and published internally. The internal plan has more details that are used for planning, resourcing and costing. Project details, such as responsible persons, management teams, etc. are found in the individual project plan.

The approaches and methods used by CNSC staff to conduct compliance verification as part of the power reactor regulatory program have not seen a significant change as a result of the pandemic, other than an increase in the application of hybrid and remote techniques. These techniques were established prior to the pandemic and were used on occasion - primarily for the conduct of pre-inspection meetings, desktop review of documentation, exit meetings when conducted following the on-site week, and at times when specialists were unavailable for travel. During the six-week period in the spring of 2020 in which site inspectors were not physically accessing the site due to emerging pandemic concerns, the use of remote inspection techniques was increased and expanded. New videoconferencing software was adopted to improve access to, and improve ease of, virtual meetings. Techniques such as recording or transmitting video feed of activities such as fire drills were used during the period when site inspectors had returned to on-site activities but travel of specialist staff from headquarters was still limited. The pandemic led to a small number of inspections being conducted entirely by remote methods, but a hybrid approach has been identified as preferable to entirely remote inspections.

While these are not new approaches or methods, the success of conducting select portions of inspections such as advance preparation, document review, and administrative meetings such as entrance and exit meetings remotely have encouraged their continued and expanded use on a more routine basis. Some inspection activities such as field verification of equipment status, control room inspection, observation of work activities, emergency exercises, and some meetings were found to benefit from on-site presence, both of the site inspectors, and of the specialist staff. A hybrid approach to inspection will continue to be used to improve the efficiency of on-site information gathering.

CNSC is expecting licence applications for SMRs at the Darlington site and Chalk River Laboratories. One of the CNSC's regulatory readiness pillars for SMR reviews is, "a capable workforce with sufficient capacity and technical expertise…"

(1) Please discuss the challenges (if any) that CNSC has faced with recruiting and retaining staff with the technical expertise to evaluate SMR/emerging technologies in licence applications.

The CNSC created and implemented a SMR integrated resource strategy to create a pool of qualified junior and intermediate level candidates that hiring managers could select from as well as leveraging internal talent. The job posting received over 500 applications for mid-career-level positions. The skill sets of the candidates ranged from those with significant nuclear experience and those that were recent graduates with no nuclear experience but an interest in regulating innovative technologies. CNSC created a streamlined process to evaluate candidates.

There have been some challenges in recruiting senior positions externally where significant experience is required. However, the CNSC is considered a top employer (e.g., the hybrid-first work policy that allows flexibility for candidates). CNSC retention of qualified staff is excellent. It is common for staff in the Regulatory Operations and Technical Service Branches to be hired externally at junior or mid-career level, promoted over time and remain at the CNSC until retirement. Retirees from these areas often delay their retirement, staying on average 5 and a half years beyond when they are eligible to retire.

The ninth Canadian national report states that “During the reporting period, the nuclear industry, the CNSC and CSA Group continued to collaborate to strengthen Canada’s program for nuclear standards,” and CSA Group has revised CSA N289.3:20 (publication year: 2020), CSA N289.2:21 (publication year: 2021) and CSA N289.4:22 (publication year: 2022).

Taking into consideration “the large uncertainty in the seismic hazard” as explained in the sixth Canadian national report (page 280), revising these standards shows that Canada has made significant effort to improve seismic standards to ensure the safety of nuclear power plants.

Could you please provide more details on the collaborative activity to improve CSA Group standards on seismic qualification?

Does CSA Group adopt a policy to revise seismic standards on a regular basis based on the latest research or new knowledge?

CSA group is responsible for the development and improvement of CSA nuclear standards. The CSA standard development process is a consensus process. CNSC staff actively participates in the committees responsible for the seismic standards. More on the standards’ development process is available from CSA Group (https://www.csagroup.org/ ).

The CSA Group requires that standards be reviewed every five years and are either reaffirmed (if there is nothing that requires changes in the standard) or revised to implement changes through a structured and traceable process, governed by the CSA management system. Changes to a standard can be prompted based on proven new research and knowledge.

The report states that the amendment to the Class I Nuclear Facilities Regulation that addresses lessons learned from the Fukushima Daiichi Accident was published and came into force in October 2017.

The amendment might be based on the assessment by the CNSC Fukushima Task Force and The Fukushima Daiichi Accident: Report by the Director General (the DG-IAEA Report) as explained in the sixth Canadian national report from page 61 to page 63 and in the seventh Canadian national report from page 56 to page 57, respectively.

(1) As the DG-IAEA Report refers to the interim and final reports by the Investigation Committee established by the Cabinet (Japanese government) and the report by the Independent Investigation Commission established by the National Diet of Japan, would you please share CNSC’s view of the above-mentioned reports?

(2) Did these reports provide Canada with a helpful perspective in areas of seismic safety of NPPs?

Generally speaking, licensees are required to comply with their licensing basis, which includes currently applicable laws and regulations, their individual licence, and the safety and control measures they described in their licence applications. A licensee is not automatically required to implement recently-published CSA standards, including recent revisions. That requirement is restricted to CSA standards specified in the licence and ones cited in the licence application and the documents that support the licence application. The Commission may recommend that a licensee implement a recently-published or revised CSA standard, and CNSC staff may request implementation plans also. Conversely, a licensee may voluntarily ask the CNSC for acceptance to implement a new or revised standard, e.g., if it offers additional clarity or alternative approaches. See Q ID 29132 for an example of a CNSC REGDOC that is outside the licensing basis of existing CANDU NPPs - for such a document, the licensees would consider it during periodic safety review (PSR), which would determine the extent to which it can be practicably implemented (e.g., in whole or partially).

See response to Question ID 32472 for additional discussion.

CNSC regulatory document REGDOC-2.11.2, Decommissioning provides requirements and guidance for all phases of decommissioning, from planning for to completion of decommissioning. This regulatory document is complemented by the requirements and guidance in CSA N294, Decommissioning of facilities containing nuclear substances.

REGDOC-2.11.2 states that the licensee shall inform the CNSC, in writing, prior to shutting down a facility, location or site permanently or ceasing to manage, possess, use or store nuclear substances. For nuclear facilities with a Class I or a uranium mines and mills licence, the licensee shall submit to CNSC staff, for acceptance, the following documents, in order to transition from operation to decommissioning:

• a permanent shutdown plan, which includes the steps to transition the facility from operation to a permanent shutdown state
• a stabilization activity plan: comprises steps for the facility's transition from a permanent shutdown state to a stable state for decommissioning
• a detailed decommissioning plan

The typical phases of decommissioning are: planning for decommissioning, preparation for decommissioning, execution of decommissioning and completion of decommissioning.

Planning for decommissioning is conducted under a licence to operate. Execution of decommissioning and completion of decommissioning are conducted under a licence to decommission. Preparation for decommissioning is conducted under a licence to operate; however, some preparation activities, such as stabilization activities, may be conducted under a licence to decommission. Stabilization activities are conducted to transition the facility from a permanent shutdown state to a stable state for decommissioning. Stabilization activities may be performed under either a licence to operate or a licence to decommission, depending on the site-specific licence. Stabilization activities of reactor facilities may include defueling the reactor, draining and storing cooling water from the reactor main systems, draining water from secondary and auxiliary cooling systems, cleaning and decontaminating, maintaining cooling for the irradiated fuel bays, transferring the spent fuel to dry storage, modifying the operating conditions/programs to align with the state of the facility, performing extensive surveys and maintaining routine surveillance of the facility.

"REGDOC-1.1.4 Licence Application Guide: Licence to Decommission Reactor Facilities - Not drafted"

Please elaborate on how the CNSC is enforcing requirements for decommissioning, knowing that the regulatory guide has not been drafted? What legal basis does the CNSC use to enforce such requirements?

The Class I Nuclear Facilities Regulations (CINFR) provides general requirements for a licence application (Section 3) as well as specific application requirements for a Licence to Decommission (Section 7). Paragraph 3(k) of the CINFR requires the inclusion of the proposed plan for the decommissioning of the nuclear facility or site.

CNSC regulatory document REGDOC-2.11.2, Decommissioning provides requirements and guidance for all phases of decommissioning from planning for, to completion of, decommissioning. This REGDOC is complemented by the requirements and guidance in CSA N294, Decommissioning of facilities containing nuclear substances.

"For new NPPs, information on decommissioning plans and financial guarantees (FGs) is required early in the licensing process. The Class I Nuclear Facilities Regulations require an applicant to provide information on its proposed plan for decommissioning a nuclear facility or site."

Does the CNSC have requirements for a submission on decommissioning during the licensing phase? If so, could you refer to the document containing such requirements and elaborate on the criteria used to assess the submissions?

High-level criteria regarding decommissioning can be found in the following CNSC regulatory documents:

• REGDOC-1.1.1, Site Evaluation and Site Preparation for New Reactor Facilities, Version 1.2, section 4.11.2
• REGDOC-1.1.2, Licence Application Guide: Licence to Construct a Reactor Facility, Version 2, section 4.11.3
• REGDOC-1.1.3, Licence Application Guide: Licence to Operate a Nuclear Power Plant, Version 1.2, section 4.11.5
• REGDOC-2.11, Framework for Radioactive Waste Management and Decommissioning in Canada, Version 2

More detailed information is provided in regulatory document REGDOC-2.11.2, Decommissioning and CSA Group standard N294, Decommissioning of facilities containing nuclear substances. Information on FGs is provided in REGDOC-3.3.1, Financial Guarantees for Decommissioning of Nuclear Facilities and Termination of Licensed Activities.

It is stated that "As mentioned, several of the suggestions were not directly related to NPPs. However, those that were relevant covered topics such as: • ensuring qualified and competent staff to regulate existing facilities as well as emerging technologies; • consolidation of safety policies into a single document; • the formalization of inspector exchanges between sites; • ensuring the objectivity and independence of on-site inspectors. The CNSC will be addressing these suggestions through various initiatives and the formalization of existing practices."

What is the status of the review on the practices and the formalization by the CNSC for "ensuring the objectivity and independence of on-site inspectors"?

The CNSC has reviewed the aviation industry and transportation industry as potential areas for learning about harmonization of regulatory processes. The CNSC is looking to other industries, including benchmarking of processes, as regulatory readiness activities continue on international harmonization and assessing SMRs on a fleet approach. In addition, the CNSC is participating in the IAEA Nuclear Harmonization and Standardization Initiative, which aims to improve the effectiveness of regulatory reviews and explore opportunities to harmonize approaches to licensing and regulating advanced reactor technologies.

For the aviation industry specifically, CNSC reviewed the regulatory lessons learned from the Boeing 737 Max accidents in 2018 and 2019. A working group reviewed information on the United States Federal Aviation Administration’s aircraft certification process for potential relevance to the CNSC’s regulatory oversight of new and existing NPPs. Although there were no particular recommendations related to international harmonization, it did recommend, among other things, updates to internal work instructions, processes, and in some cases, the regulatory framework for areas including advanced technologies.

The licensee's management system is required to have a process to prevent, detect and control counterfeit, fraudulent and suspect items (CFSI). The licensee's CFSI process is reviewed as part of CNSC staff review of the licensee's management system documentation. CNSC's inspection on the licensee's supply chain includes a verification of the effective implementation of the CFSI process.

CNSC staff also participate as observers at meetings of the Nuclear Procurement Issues Corporation and the CANDU Procurement Audit Committee, where CFSI affecting Canadian nuclear facilities are evaluated and discussed.

It is mentioned in the national report that the CNSC has a well-established 15-month co-op student program that comprises three rotations of five months each.

Is the co-op student program limited to only students from Canada or can students from abroad express an interest to participate and benefit from this program? How do students become aware of this program and how it is communicated to universities?

The appointments are made by the Governor in Council through an Order in Council, which specifies the tenure of the appointment and the term of office. Remuneration for part-time appointments is established in a separate Order in Council. The Order is signed by the Governor General acting on the advice of Cabinet. Appointments are subject to an open, transparent, and merit-based selection process supported by the Privy Council Office.

Subsection 10 (5) of the Nuclear Safety and Control Act provides that “[E]each permanent member holds office during good behaviour for a term not exceeding five years.” Subsection 10 (7) states that a member is eligible to be re-appointed. The exact length of the term and whether a member is re-appointed or not is a decision made by the Governor in Council. Each appointment is separate, and the term can vary from one member to the other. The term of an appointment can be for either a specific or indeterminate period. When a specific period is indicated, the appointment lapses at its expiration, unless there is an executive decision to the contrary.

The tenure of an appointment for the temporary permanent members is “during good behaviour” (may only be removed for cause). The President’s tenure is “at pleasure” (removal must satisfy requirements of fairness and natural justice).

The NSCA provides that a Commission member “shall not, directly or indirectly, engage in any activity, have any interest in a business or accept or engage in any office or employment that is inconsistent with the member’s duties.” A member who becomes aware of such a conflict of interest “shall, within one hundred and twenty days, terminate the conflict or resign from the Commission.” Members are also subject to Canada’s Conflict of Interest Act.

CNSC employees, like all federal public servants, are also subject to the Values and Ethics Code for the Public Sector. This requires public servants to take “all possible steps to prevent and resolve any real, apparent or potential conflicts of interest between their official responsibilities and their private affairs in favour of the public interest.”

CNSC employees are also subject to the CNSC Conflict of Interest Policy, which includes detailed post-employment provisions. The Commission President has designated the Director of the Internal Audit, Evaluation and Ethics Division (IAEED) as responsible for putting in place infrastructure and controls to effectively administer the conflict of interest policy, including identification of reportable assets and liabilities, ensuring that persons offered employment are aware of the policy and that non-compliance may result in termination of employment, and reminding employees who are preparing to leave the CNSC of the policy. IAEED also administers the Conflict of Interest and Post-employment Program that offers employees tools to prevent and avoid situations that could create the appearance of a conflict of interest or result in a potential or actual conflict of interest.

The nuclear industry’s views were sought as an input into Project Athena. The project took place in three phases: planning, execution, and decision-making with a goal of generating high quality, evidence-based information on CNSC expenditures and developing credible options for change. During the execution phase, the project generated evidence through multiple lines of evidence, including by seeking out views from external stakeholders, Indigenous groups and the public on future drivers that may impact CNSC's work. Through research, licensees indicated they were concerned about the costs associated with the regulatory burden and that increased communication and consultation would strengthen confidence in the CNSC.

The majority of the proposals (called “staff suggestions”) are being implemented directly by the various business units in the CNSC. Most of these suggestions offered a practical view of changes considered to be "quality of life" improvements that would bring improvements to the day-to-day work of staff. In total, staff contributed 691 suggestions to Project Athena, by either submitting a suggestion form directly to the review or participating in a design-thinking session on pre-determined topics.

Through the execution phase of the project, the evidence collected was synthesized in order to develop potential change options. Through facilitated discussions with senior executives, the CNSC has decided to prioritize 11 transformation initiatives in three main areas:

• Improving operational effectiveness: exploring how CNSC can leverage digital technology to focus on safety and have a consistent approach across all regulatory programs.
• Transforming how the organization delivers internal services: investigating how to provide managers with richer, deeper information that allows them to do their jobs better and allows internal services to focus more on integrated activities.
• Improving the quality of the work experience: adopting efficiencies to improve the day-to-day work experience.

There is a high degree of interconnectivity and complexity to these transformation initiatives. They represent a large and complex scope of change that impact many business units and are likely to present cultural shifts in the CNSC over several years. To ensure the highest chances of success, the CNSC has decided to create a dedicated change management function - a Transformation Management Office - to oversee these transformations. This office will ensure the organization considers all changes, whether stemming directly from Project Athena or not, as a single suite of integrated changes to be delivered in a coordinated way.

The report states that "CNSC staff communicate with… staff of Natural Resources Canada (NRCan) in areas of mutual interest. NRCan formulates the Government of Canada's policy regarding uranium, nuclear energy and radioactive waste management."

Since the Geological Survey of Canada (GSC) is part of the Earth Sciences Sector of NRCan, do CNSC staff communicate with staff of GSC in areas of seismic hazard assessment?

In preparation for CNSC review of emerging SMR technologies, the national report describes CNSC's strategy for regulatory readiness. The report states that CNSC established a steering committee to provide governance, ensure that pillars of regulatory readiness are appropriately balanced, and prioritize activities that support the strategy.

(1) Please discuss significant findings of the steering committee that have shaped CNSC's strategy for regulatory readiness.

(2) The report mentions looking beyond the nuclear sector for models/examples of regulating advanced technologies. Please discuss parallels identified to other industries and explain how those influenced CNSC's strategy for SMR regulation.

1) The CNSC's SMR readiness effort is supported by an organization-wide matrix and governance bodies, such as the SMR Steering Committee (SMR SC). The SMR SC, comprised of senior management from across the organization, provide high-level direction regarding how to strategically approach the development of the CNSC's SMR Readiness Project. This direction informed the definition and development of the project's four pillars: i) regulatory predictability; ii) capacity and capability; iii) policy and shared responsibilities, and iv) international harmonization and collaboration. Under these pillars, a suite of projects have been strategically prioritized, scoped and defined (managed by the SMR Readiness Project Management Office) to ensure the CNSC can efficiently and effectively review SMR license applications within committed regulatory timelines without compromising the safety or security of Canadians, Indigenous communities and nations, or the environment.

(2) The CNSC has reviewed the aviation industry and transportation industries as potential areas for learning about harmonization of regulatory processes. The CNSC is looking to other industries, including benchmarking of processes, as regulatory readiness activities continue on international harmonization and assessing SMRs on a fleet approach.

A specific example is CNSC's review of regulatory lessons learned regarding the Boeing 737 Max accidents from 2018 and 2019. CNSC staff commissioned a multi-disciplinary working group to review the publicly-available accident investigation reports and other official reports, which reviewed the United States Federal Aviation Administration’s aircraft certification process. The working group focused the review on potentially relevant information for the CNSC’s regulatory oversight of new and existing NPPs. It identified both strengths of the CNSC and recommendations, for example, in ways to update internal work instructions, processes, and in some cases, the regulatory framework, as they relate to new and existing technologies.

Commission members can be removed under subsection 10(5) of the Nuclear Safety and Control Act, which provides that “Each permanent member holds office during good behaviour… and may be removed at any time by the Governor in Council for cause.”

Appointment “during good behaviour” means that the appointing authority can remove the appointee only for cause, meaning for some fault on the part of the appointee, which would have to be established through a fair and reasonable process.

As previously mentioned, the “Governor in Council” is, strictly speaking, the Governor General acting on the advice of the Prime Minister (PM) and Cabinet, but is in practice the PM and Cabinet. Typically, the PM and Cabinet act on the advice of the Minister or Ministers responsible for the portfolio; in the case of the CNSC, this is the Minister of Natural Resources. This means that the Cabinet may remove a permanent member of the Commission at any time “for cause”, that is for some kind of misconduct. As noted above, this misconduct would have to be demonstrated through a fair and reasonable process, that is to say the member would need to be given a reasonable opportunity to refute the allegations of misconduct. The member would have recourse to the Federal Court system to ensure that this process was a fair one.

The President of the Commission is designated by the Governor in Council (that is, the PM and Cabinet) from among the permanent members of the Commission. As a permanent member of the Commission, the President holds office during good behaviour and can only be removed as a permanent member for cause. (See the response to Question ID 31174 for context.)

However, the President’s designation in the function of the President and CEO of the Commission is one which is made by the Governor in Council “at pleasure”. That is to say, the Governor in Council (Cabinet) may rescind the designation of the President at any time and for any reason, so long as a minimum threshold of procedural fairness is observed.

In late 2007, Parliament enacted emergency legislation to allow a CNSC licensee to produce medical isotopes, notwithstanding the fact that this would mean non-compliance with the conditions of the licence, for a period of 120 days owing to a global emergency (i.e., a medical isotope shortage). This temporarily bypassed the regulatory oversight of this issue. The President of the Commission at that time offered public criticism of this move, which led the Cabinet to lose confidence in the President and consequently to rescind her designation as President. It is important to note that despite this, the former President retained her position as a permanent member of the Commission (she eventually chose to resign as a Commission member).

"The CNSC maintains trained, experienced inspectors at all NPP sites with operating reactors on a permanent basis. They provide a high degree of day-to-day interaction with the licensees and scrutiny of their activities"

Could you elaborate on the powers of on-site inspectors and whether they can make decisions on safety related issues or make recommendations to the licensee? Did Canada experience challenges in adopting such day-to-day interactions knowing that the licensee is responsible for safety?

The NSCA defines the powers of CNSC inspectors (SS 32-36). For example, inspectors designated under the act may order that a licensee take any measure that the inspector considers necessary to protect the environment or the health or safety of persons or to maintain national security or compliance with international obligations to which Canada has agreed.

In practice the CNSC’s enforcement strategy operates on the principle that, where a non-compliance is identified, the licensee is encouraged to return to compliance using the least punitive form of enforcement practicable. The strategy also relies on the ability to escalate enforcement should the prior method of returning the licensee to compliance be insufficient. In all cases, it is the responsibility of the licensee to ensure the safe operation of the plant, and the protection of the workers, the public, and the environment.

On-site inspectors routinely conduct inspections, monitor key licensee databases (e.g., corrective action database, official shift logs, work management database, etc.), routinely attend licensee operational decision-making meetings and meet regularly with licensee senior management. In the event a non-compliance with a regulatory requirement is identified, CNSC will often raise a notice of non-compliance (NNC) as the first enforcement measure. The licensee will often be required to submit a corrective action plan, with clearly-defined actions and target completion dates, to address the nature of the non-compliance, for CNSC review and acceptance. Should the non-compliance recur, or a similar event occur, CNSC staff determine whether the enforcement action initially raised should have been sufficient to deter recurrence; if so, CNSC staff may consider escalating enforcement beyond the NNC. The CNSC has many tools available under its enforcement strategy to return a licensee to compliance with requirements—e.g., warning letters, AMPs, de-certification, prosecution, etc.—all of which have defined criteria for their use. The principle of using the least-punitive enforcement measure to achieve compliance still applies, even in the case of escalating enforcement; however, the severity of the measures applied increase.

Repeated findings can escalate into graduated enforcement, especially in the case where previous enforcement measures (e.g., NNCs, warning letters) have been applied yet have failed to prevent recurrence. CNSC staff have discretion to recommend escalating enforcement to their line management if they have evidence of a continued lack of compliance to regulatory requirements or expectations, or where previous corrective measures have failed in their implementation.

Canada has not experienced any challenges in this approach.

All licensees are required by their licence to follow the requirements of CSA Standard N286-12: Management System Requirements for Nuclear Facilities. Within this standard there are requirements for the management of all workers including contractors, along with requirements to ensure all workers are competent and qualified for the work that they are performing. Given this, all of the NPP licensees in Canada have processes and procedures for the management of contractors working for their facilities.

No special or additional provisions or rules have been established, since the Canadian regulatory framework already holds the licensee accountable for safety and all activities in support of the licence. This responsibility and measures to discharge this accountability are required to be built into their management system. The CNSC uses CSA N286-12 as a source of CVC for oversight of the licensees' management systems. CSA N286-12 itself has requirements for licensee oversight of contractor activities.

A financial guarantee (FG) for decommissioning must be established to fund the activities described in the preliminary decommissioning plan (PDP). The NSCA stipulates that the FG shall be in a form that is acceptable to the Commission. The NSCA and associated regulations require that licensees make adequate provision for the safe decommissioning of their facilities. Regulatory guidance and the associated acceptance criteria for establishing an FG is provided in CNSC REGDOC-3.3.1, Financial Guarantees for Decommissioning of Nuclear Facilities and Termination of Licensed Activities. The regulatory document provides requirements and guidance on the attributes of an acceptable FG in terms of liquidity, certainty, adequacy of value and continuity. The FG ensures that applicants and licensees establish and maintain sufficient funds to decommission a licensed location and dispose of any associated nuclear substances.

Licensees are required on a 5-year basis to review their PDP and associated FG and submit to the Commission a written report confirming that the FG for decommissioning costs remains valid and sufficient to meet the decommissioning needs.

The CNSC has a compliance program covering each SCA. For the Management System SCA, planned inspections and compliance assessments are carried out on key elements of the licensee's management system, including problem and event cause and resolution, engineering change control, contractor management, supply management, configuration management, self and independent assessments and management system effectiveness. The frequencies of these inspections range from once per year to once every five years.

Every licensee has a review cycle for each of their programmatic and process documents. These review cycles vary from two to five years, depending on the program and process.

Security culture considerations can be assessed in the same manner as safety culture - through application of a robust and systematic, multi-phased methodology and appropriate treatment of data (e.g., through the use of multiple methodologies: document review, observations, interviews, focus groups, questionnaires).

In general, the security aspects included with the safety culture assessment are focused on getting knowledge of the workforce's awareness of various security-related issues including physical security, cyber security and information security. Workers are assessed to ensure they understand their role in ensuring all aspects of security. Canadian licensees have gained some very good insights on the security culture at the Canadian NPPs, allowing them to take some actions, such as related to information technology systems and controlled nuclear information.

The report states that "The foundation of safety culture is further established by constantly… promoting a "just culture" that aims to learn as much as possible from events or near misses without removing the possibility of holding persons responsible for their actions."

(1) Does the Canadian legal system encourage honest disclosure of human error and ensure accountability at the same time?

(2) Would you please share the experience of "just culture" from a legal viewpoint?

The Canadian legal system does not have a specific framework dealing with disclosure of human error and the resulting accountability. Accountabilities are built into various systems, with, for example, employees in a nuclear field being accountable to their employer, the employer being accountable to the CNSC, and the CNSC as a whole being accountable to Parliament. The Commission members are accountable to the Governor in Council, although the Governor in Council has limited powers to remove a permanent member. (The Governor in Council is the Governor General acting on the advice of the Prime Minister and Cabinet but is in practice the Prime Minister and Cabinet). The NSCA contains a provision, paragraph 48(g), making it an offence to “[take] disciplinary action against a person who assists or gives information to an inspector, a designated officer or the Commission in the performance of the person’s functions or duties”. Licence conditions, as well as the NSCA and associated regulations, also require licensees to report regularly to the CNSC. More generally, Canada is a common law jurisdiction which has a highly-developed body of jurisprudence dealing with matters of negligence.

CNSC REGDOC-2.2.1 (currently being revised) defines “just culture” as:

A workplace environment where issues related to human performance are assessed in the full context of a given situation to provide fair decisions, and where people are encouraged to provide honest feedback and report errors without fear of reprisal. Note: A just culture does not tolerate negligence, or destructive acts.

Canadian law does not recognize a concept of “just culture” per se, although the idea has been discussed in certain law journals, in particular, in the context of disclosure of human error in medical malpractice and certain employers, in particular in the medical field, have implemented “just culture” policies in their workplaces which encourage honest and proactive disclosure of human error by taking a non-punitive approach to such disclosures.

Section 10(d) of the national report (page 97) states that CNSC reviews the safety culture self-assessment of the licensee and provides feedback.

Please explain if the feedback provided by the CNSC becomes suggestions or recommendations on the licensee’s safety culture activities. If so, is it compulsory for the licensee to implement it?

In pages 94-96 of the national report, nuclear operators have different cycles for self-assessment of safety culture. (Ontario Power Generation: 5 years, Bruce Power: 3-6 years, NB Power: 5 years)

(1) What is the average cycle for self-assessments for Canadian nuclear operators?

(2) If a cycle is set, what are the reasons and grounds for it?

(1) In the past, safety culture self assessments in Canada were typically conducted on a 3-5 year cycle. With the publication of CNSC REGDOC-2.1.2, Safety Culture, they are required at least once every 5 years. In the case of the 6-year cycle for Bruce Power, which was a one-time exemption granted due to the COVID pandemic.

(2) The grounds for minimum of once in a 5-year cycle is based on the requirements of REGDOC-2.1.2. The REGDOC requirements were based on what was deemed a reasonable timeframe for conducting these assessments, given the time it typically takes for a culture to change. The REGDOC does not restrict conducting these assessments on a more frequent basis should there be a significant cultural issue identified.

In REGDOC-2.1.2 Safety Culture, section 3.2, Preparing for the Safety Culture Assessment, it is stated that a team of external experts and employees is deployed to assess safety culture, and this increases the objectivity of safety culture assessments but runs the risk of lowered objectivity in self-assessment.

- In implementing safety culture self-assessment, as stated in section 10(b) of the national report, is there a process incorporated in the planning stages for the assessment to confirm objectivity is maintained in Canadian NPPs?

The interrelated concepts of safety and security culture can be assessed in the same manner as safety culture - through application of a robust and systematic, multi-phased methodology and appropriate treatment of data (e.g., through the use of multiple methodologies: document review, observations, interviews, focus groups, questionnaires).

The CNSC regulatory oversight approach regarding licensee’s safety and security culture takes a more promotional approach as opposed to traditional regulatory compliance. To this end, the CNSC monitors the licensee’s assessment of their safety and security culture and maintains awareness of their cultural insights and any corrective actions they may undertake as a result of their assessment. Presently, the CNSC does not intend to be prescriptive in this regard, as the licensee is best-positioned to envision changes that may positively effect changes to their organizational safety culture. It should however be noted that if a regulatory non-compliance were to be identified through the self-assessment process, the CNSC would use traditional regulatory means to address the situation.

The CNSC follows an established process for confirming effectiveness of licensee corrective actions; safety culture corrective actions are not treated differently. It should be emphasized that the onus is on the licensee to perform suitable analysis to confirm the corrective actions have met their intended purpose or function.

Canada's 8th CNS report stated that CNSC completed a safety culture assessment and identified findings and recommendations in a management action plan. The report also stated a follow-up assessment would be conducted in May 2022 to confirm effectiveness of the actions. The current report recaps the assessment and states a follow-up will be conducted during the next reporting period but does not discuss the results of the May 2022 assessment on CNSC's management action plan.

(1) Please clarify if the assessment was conducted.

(2) If so, please discuss the results of the assessment.

In Article 11 of the national report (page 102), it is stated that the licensee training program provides operations and maintenance training.

(1) How often is the maintenance training given?

(2) Is the maintenance training mandatory?

(1) There are several occurrences of maintenance training per year, typically in the 100 - 200 hours per year range dependent on the role of the worker.

(2) Maintenance training is mandatory to maintain qualifications for certain work tasks.

Formal succession plans are in place for the Senior Manager role and above. Succession planning for Section Managers and Department Managers is managed via the development planning process and performance review process. Interested and selected high-potential employees are ‘linked’ in the training program and receive additional leadership training as required. Also, an “Emerging Talent” program has been developed to train high-potential employees on the skills for leadership – these individuals are placed on respective succession plans.

The Leadership Team receives basic management training and extended leadership courses. Initial training includes the leadership academy (2 week session), where employees learn how to coach employees, manage difficult situations, build teams and gain an understanding of leadership and the union environment. Following basic leadership training, individuals receive extended training such as the nuclear professional development seminar, advanced people skills (emotional intelligence), personality and communication styles, and fierce conversations. Also, all new managers must complete a job familiarization guide to ensure that they understand business practices, strategic vision, culture, and behavioural practices so they can successfully integrate into the leadership team.

CNSC's regulatory framework contains REGDOCs in the 2.2 series (for the Human Performance Management safety and control area) that include requirements pertaining to “training, qualification, certification, staffing” and more, e.g., REGDOC 2.2.2-Personnel Training, REGDOC 2.2.3- Personnel Certification, Volume III: Certification of Reactor Facility Workers, and REGDOC 2.2.5-Minimum Staff Complement.

For certification, the requirements are closely tied to the concept of operations of the plant, and thereby, the SMR being technology employed. The current requirements and guidance, which are based on experience from operating CANDUs, provide a solid, high-level starting point on which to base requirements and guidance for SMRs. These requirements may be applied in accordance with the graded approach documented in REGDOC-3.5.3, Regulatory Fundamentals, subsection 5.4 throughout the life cycle of future reactor facilities. Canada does not set detailed personnel certification requirements applicable to the personnel involved in the site preparation and construction phases, allowing applicants to propose alternatives to existing requirements in accordance with REGDOC-3.5.3, Section 3 and REGDOC-1.1.5, Supplemental Information for Small Modular Reactor Proponents, Subsection 3.2.

For SMRs that are first-of-a-kind (FOAK) designs, certification schemes for reactor personnel and initial cohorts of certified workers will be developed during the licensing process, as per the licence application guides REGDOC-1.1.2, Licence Application Guide: Guide to Construct A Reactor Facility and REGDOC-1.1.3, Licence Application Guide: Licence to operate a Nuclear Power Plant. While this performance-based approach may entail some uncertainty in the early licensing stages, as opposed to more prescriptive approaches, it also offers added flexibility in adapting the regulatory framework to meet the challenges posed by FOAK designs.

Regarding qualification, the high-level requirements in REGDOC 2.2.3 Volume III and REGDOC 2.2.2 would apply for SMRs. The requirements for training and staffing in REGDOCs 2.2.2 and 2.2.5, respectively, are both technology neutral. Therefore, they are directly applied to the regulation of SMRs

The Canadian national report states that “In 2016, CNSC published discussion paper DIS-16-05, Human Performance… CNSC incorporated feedback from the discussion paper into the new version of REGDOC-2.2.1, now titled Human Performance which is scheduled for public consultation in 2022,” and both the discussion paper DIS-16-05 and the new version of REGDOC-2.2.1 refer to books written by Professor Sidney Dekker.

What is the background of incorporating knowledge from books written by Professor Sidney Dekker?

In effort to inform the REGDOC, CNSC staff continually review literature relating to human performance from both domestic and international sources. While CNSC staff have incorporated a range of material in REGDOC-2.2.1 Version 2, the noted introductory text from Dekker was included as an accessible reference that addresses many of the concepts contained in the REGDOC:

Ashgate, The Field Guide to Understanding 'Human Error', Third edition, Dekker S., Australia, 2014.

The CSA Group has published a commentary document to provide guidance for users of the standard to understand the intent of the clauses. The commentary document provides guidance on the application of graded approach with some examples. Following are some examples of relatable everyday work processes that apply a graded approach:

• There are different organizational levels for approval of purchase orders for items and services based on cost and other business risks.
• Some problem identification and resolution processes segregate problems into high, medium, and low significance, and the resolution process has tiered levels of investigation and effectiveness reviews such as self-check or independent verification.
• The supply of items specifies different levels of management systems/quality assurance (QA) standards depending on the significance and complexity of the items and services and oversight frequency. The extent of supplier assessment is also based on business risk factors such as QA level, the supplier’s past performance, and other factors. Some purchases require three-way match, while others require f

our-way match before payment is tendered.

The graded approach is not implemented on a day-to-day basis; rather, it is applied during the development of a process. Once the process exists, it is implemented and translated into management system documents such as procedures or instructions; workers follow these without any further need to apply the graded approach.

It is stated that "In 2019, OPG was notified by one of its vendors that a supplier of ingots, since 1995, had been falsifying chemical analysis results obtained from the top and bottom of the ingots when they did not meet customer specifications. A supplier performed material chemical analysis of the tubes extruded from those ingots and found them to meet the necessary specifications. These tubes were used in Pickering bleed condenser tubes and Darlington shutdown cooling heat exchangers. Since the material met code requirements, OPG did not need to formally approve the non-conformance reports nor obtain approval of the pressure boundary authority. OPG assessed the extent of condition and found 14 history dockets, since 1995, containing material that was produced and tested by the supplier. Operating experience (OPEX) notifications were sent to COG and WANO."

Could you describe the actions taken by the operating organization of the NPP and the CNSC (besides sending notifications to COG and WANO)?

It is stated that "In 2019, OPG was notified by one of its vendors that a supplier of ingots, since 1995, had been falsifying chemical analysis results obtained from the top and bottom of the ingots when they did not meet customer specifications. A supplier performed material chemical analysis of the tubes extruded from those ingots and found them to meet the necessary specifications. These tubes were used in Pickering bleed condenser tubes and Darlington shutdown cooling heat exchangers. Since the material met code requirements, OPG did not need to formally approve the non-conformance reports nor obtain approval of the pressure boundary authority. OPG assessed the extent of condition and found 14 history dockets, since 1995, containing material that was produced and tested by the supplier. OPEX notifications were sent to COG and WANO."

Could you explain the measures taken by NPP operating organizations for an item that meets the requirements of the laws and regulations but does not meet the technical specifications?

With reference to article 13 of the Canadian national report, Korea would like to ask the following question:

How does the CNSC verify that the licensee's management program complies with CSA N286-12 and has been implemented effectively in accordance with their management program?

With reference to article 13 of the Canadian national report, Korea would like to ask the following question regarding CFSI:

Does the CNSC monitor or inspect the supplier's CFSI-related program?

Based on Table 8: Quantitative safety goals and the following description, the CNSC quantitative safety goal for significant core degradation is less than 10E-5 per reactor-year. Per page 129, the IAEA specific Safety Guide SSG-3 specifies a frequency of severe core damage of less than 10E-4 per reactor-year.

Question: Could you please explain the differences between the definitions of significant core degradation and severe core damage, and between their corresponding thresholds?

In Table 8: Quantitative safety goals, there are only quantitative safety goals for small-release frequency and large-release frequency for level 2 PSA.

The large early release frequency (LERF) is usually required for operational NPPs for routine configuration of risk management. Could you please explain why there is no safety goal for LERF in table 8?

Does the CNSC involve experts from external support organizations, or individuals, who have specialist skills in particular areas of the assessment and verification of safety?

Does the CNSC have regulations/guidelines for selecting and involving experts from external support organizations?

Broadly speaking, the NSCA enables the CNSC to “appoint and employ such professional, scientific, technical or other officers or employees as it considers necessary for the purposes of this Act” (subsection 16(1)). Hiring is subject to CNSC staffing and human resources policies and procedures. Additionally, Section 21 of the NSCA authorizes the Commission to “enter into contracts for the services of any persons having technical or specialized knowledge of any matter relating to the work of the Commission, to advise and assist the Commission in the exercise or performance of any of its powers, duties or functions under this Act…”.

The CNSC cooperates with other organizations and jurisdictions to foster the development and application of a consistent, effective regulatory framework in Canada. The CNSC also cooperates with other jurisdictions to increase efficiency and effectiveness; for example, entering into formal arrangements where appropriate. See section 8.1 (g) of Canada’s report for commentary on cooperation with other regulatory bodies. An example of international cooperation agreement is at the following link: https://nuclearsafety.gc.ca/eng/resources/international-cooperation/international-agreements/cnsc-usnrc-smr-advanced-reactor-moc.cfm

According to the IAEA standards, SMRs have capacity between 10Mwe and 300Mwe and micro-reactors have less than 10Mwe. Depending on the capacity, the safety goals would be different.

Section 14(i)(d) of the national report (page 127) states that quantitative safety goals of a new nuclear power plant are presented in RECDOC-2.5.2 and RD-367.

- Please elaborate on the quantitative safety goals applied to SMRs.

Section 14(i)(a) of the national report (page 120) states that CNSC and NPP licensees perform a third-party assessment.

- Please explain the details and methods of the third-party assessment.

Section 14(i) begins with the general statement that the CNSC and licensees collectively conduct a wide variety of safety assessments, including third-party assessments. Section 14 (i) I describes reviews by WANO and IAEA. IAEA techniques are varied and well known. In addition, certain third-party reviews are required of the licensees (e.g., for fire protection). However, those types of assessments are not as general/broad as the ones being discussed in Section 14 (i). In this context, it is the licensees that arrange third-party assessments.

All Canadian NPP licensees have third party peer reviews conducted on a 2 year basis by the World Organization of Nuclear Operators (WANO). These peer reviews are conducted by highly-qualified staff from WANO members around the world. The peer review team typically consists of about 20 people that spend 2 weeks at the NPP observing personnel performing their jobs, conducting interviews and reviewing documentation The peer review covers a number of areas and all areas are reviewed in accordance with the WANO "Performance Objectives and Criteria". During the review, the team notes strengths that may be useful to other plants, and areas in which improvements can be made to enhance safety and reliability at the host plant. The team focuses on the workers performing their day-to-day tasks, as this is where operational success lies. The result is a confidential report to the utility identifying strengths and areas for improvement. This confidentiality ensures full, open discussion between the review team and the management of the host plant. In addition, WANO uses a continuum process to maintain close connection with the sites to allow more rapid support should performance declines occur.

All existing NPPs are subject to REGDOC 2.4.2, Probabilistic Safety Assessment for Reactor Facilities, requiring the performance of a Level 1 and Level 2 PSA. This includes consideration for the reactor core and other radioactive sources, multi-unit impacts, internal and external hazards (and combinations thereof) and includes at-power and shutdown states of operation. As such, multiple separate models are developed in most cases and have the following structure:

• Level 1 and 2 At-Power Internal Events
• Level 1 Outage Internal Events
• Level 1 and 2 At-Power Internal Fire
• Level 1 and 2 At-Power Internal Flood
• Level 1 and 2 At-Power Seismic
• Level 1 and 2 At-Power High Winds.

For multi-unit NPPs, a full scope set of PSA models are developed for a single reference unit including multi-unit impacts. The reference unit PSA is then applied to the other units limiting duplication of work. Integrated, or whole-site PSA has been applied to different degrees by the licensees to confirm that aggregate risk from all hazards remains below the established safety goals. A first-of-a-kind pilot project was conducted for Pickering in 2017 to develop a whole-site risk assessment and Point Lepreau has developed an integrated PSA model considering all hazard groups.

Article 14, 18

Pages 128, 177

The preface in CNSC REGDOC 2.5.2, Design of Reactor Facilities: Nuclear Power Plants, states that its requirements do not apply for existing facilities unless they have been included, in whole or in part, in the licensing basis. REGDOC-2.5.2 is not part of the licensing basis for the existing NPPs, which were designed many years before the REGDOC was published.

With respect to the quantitative safety goals, the existing NPPs established, as part of the licensing basis, their own safety goals in alignment with international practices, specifically the IAEA Safety Series No 75-INSAG-3 (1988), Basic Safety Principles for Nuclear Power Plants, which was updated in 1999 as INSAG-12. These are: severe core damage frequency less than 10E-4 per reactor-year and large release frequency less than 10E-5 per reactor-year. In addition to these established safety goals, licensees have also established safety targets or administrative goals that are one order of magnitude lower than the safety goals (10E-5 per reactor-year and 10E-6 per reactor-year respectively). These administrative safety goals are set as desired operational objectives to strive towards.

As part of mandatory PSR, CNSC REGDOC-2.3.3 requires the licensee, to the extent practicable, to resolve identified gaps with respect to applicable modern codes, standards, and practices. The identified gaps would include the comparison against safety goals defined in REGDOC 2.5.2. In addition, the licensees have developed internal policies to review all cases where the average risk (per year) is below the safety goal but exceeds the stated administrative target.

To conclude, there is no need for CNSC to give exception to application of REGDOC 2.5.2 requirements for the existing NPPs given they are not required to align with REGDOC 2.5.2.

The report states that "Bruce Power also added new appendices on common-mode failures, which brought detailed analysis of internal and external hazards related to such failures into the safety report for the first time. The common-mode analysis addressed… seismic events… Over the reporting period, Bruce Power worked to address CNSC comments on the new analysis."

These sentences might indicate that the licensee tried to enhance seismic safety voluntarily.

(1) If it is so, what is the background of the new analysis by Bruce Power?

(2) Is the new analysis based on the lessons learned from the Fukushima Daiichi Accident?

(1) The work carried out by Bruce Power was an enhancement of the safety analysis report to include common mode events and align with the requirements of CNSC REGDOC-2.4.1, Deterministic Safety Analysis. Note: New Brunswick Power (NB Power) and Ontario Power Generation (OPG) have also carried out this safety report improvement.

(2) This analysis was not totally based on lessons learned from the Fukushima Daiichi accident; however, the lessons learned were integrated in the new analysis.

All possible accidental external explosions are considered, but only those most relevant have been mentioned. Note that situations other than accidents, such as malevolent acts or sabotage, are dealt with separately.

The events (including explosions) described in the question falls under internal/external hazards, which are analyzed as part of the hazard analysis. If any loads/damages/challenges resulting from these hazards produce postulated initiating events, they are then analyzed via deterministic safety assessment according to the characterization of anticipated abnormal occurrences, design-basis accidents, etc.

Yes, all discharges of liquid radioactive effluent from Canadian NPPs directly to the environment are checked against derived release limits (DRLs), which are the current regulatory criteria, prior to release to the environment. The DRLs are based on a member of the public receiving a dose of 1 mSv/year. DRLs are calculated following the methodology in CSA N288.1, Guidelines for modelling radionuclide environmental transport, fate, and exposure associated with the normal operation of nuclear facilities.

For facilities with releases to the sewer, the liquid effluent is compared against conditional clearance levels in the Nuclear Substances and Radiation Devices Regulations. These conditional clearance levels are equivalent to a member of public receiving a dose of about 10 μSv/year.

The CNSC’s effective dose limit for a pregnant NEW was informed by a comparative risk analysis, public meetings and by a stakeholder consultation, conducted in the 1990s, which sought views from female workers. The rationale for proposing the 4 mSv effective dose limit for pregnant NEWs was that:

a) the risk to the embryo and the fetus associated with a dose of 4 mSv to the mother is very small;

b) the risk to the embryo and the fetus from a dose of 4 mSv is certainly very small when compared to the risks from other sources;

c) during consultations leading to the adoption of the new limit, workers affected by it indicated to the CNSC that the risk implications were acceptable; and,

d) discrimination against women was feared because some employers might conclude that the only effective method of compliance with the dose limit would be to remove a pregnant worker from work with radiation, or to not hire women at all.

As specified in section 13 of the RPRs, the effective dose limit for a pregnant NEW applies to the balance of the pregnancy starting from the date on which the licensee has been informed by the NEW of the pregnancy in writing.

Article 15 of the national report (page 139) states radiation protection requirements. In the foot note, "A Nuclear Energy Worker (NEW) is a person who is required, in the course of the person’s business or occupation in connection with a nuclear substance or nuclear facility, to perform duties in such circumstances that there is a reasonable probability that the person may receive a dose of radiation that is greater than the prescribed limit for the general public."

- Does the definition of NEW include only those working in fuel cycle facilities, or does it also include those working in other areas?

A NEW is defined in the NSCA as a person who is required, in the course of the person’s business or occupation in connection with a nuclear substance or nuclear facility, to perform duties in such circumstances that there is a reasonable probability that the person may receive a dose of radiation that is greater than the prescribed limit for the general public.

A NEW includes persons who meet the definition in connection with any licensed activity or nuclear facility under the authority of the CNSC.

Article 15 (a) of the national report (page 141) states that according to the RPR for workers and application of the ALARA principle, effective dose for the balance of the pregnancy for a pregnant NEW is set at 4mSv.

- What is the rationale for the value of 4mSv?

The CNSC’s effective dose limit for a pregnant NEW was informed by a comparative risk analysis, public meetings and by a stakeholder consultation, conducted in the 1990s, which sought views from female workers.

The rationale for proposing the 4 mSv effective dose limit for pregnant NEWs was that:

a) the risk to the embryo and the fetus associated with a dose of 4 mSv to the mother is very small;

b) the risk to the embryo and the fetus from a dose of 4 mSv is certainly very small when compared to the risks from other sources;

c) during consultations leading to the adoption of the new limit, workers affected by it indicated that the risk implications were acceptable; and,

d) discrimination against women was feared because some employers might conclude that the only effective method of compliance with the dose limit would be to remove a pregnant worker from work with radiation, or not hire women at all.

As specified in section 13 of the RPRs, the effective dose limit for a pregnant NEW applies to the balance of the pregnancy starting from the date on which the licensee has been informed by the NEW of the pregnancy in writing.

The title of Article 15 (a) (page 141) is "Radiation Protection for Workers…", which seems to imply it is about occupational exposure. However, the section also describes public dose limit. For example, "1mSv per calendar year for a person who is not a NEW" is also mentioned.

- Does this refer to a member of the public?

A ‘person who is not a NEW’ as specified in section 13 of the RPRs is not a member of the public. This is a person who does not meet the definition of a NEW but who is occupationally exposed due to their connection with the licensed activity or nuclear facility.

The dose limit for a member of the public is defined in subsection 1(3) of the RPR. It states:

For the purpose of the definition of NEW in section 2 of the NSCA, the prescribed limit for the general public is 1 mSv per calendar year.

"Each year, licensees establish challenging radiation dose performance targets based upon the planned activities and outages for the year. They are analogous to the constraints recommended in the IAEA Safety Guide GSG-7, Occupational Radiation Protection. CNSC staff members verify that the NPP licensees monitor their performance against internal radiation dose performance targets and that this information is used to improve radiation protection performance."

Does the CNSC have established requirements on monitoring of workers for internal contamination (e.g., when is internal dosimetry required, monitoring period, type of tests, etc.)?

Yes, the CNSC has established requirements for the monitoring of workers for internal contamination.

The CNSC has regulatory requirements for the ascertainment and recording of doses of radiation as per section 5 of the RPRs. Every licensee must ascertain and record the magnitude of exposure to radon progeny, the effective dose and equivalent dose received by and committed to a person who performs duties in connection with any activity that is authorized by the NSCA or is present at a place where that activity is carried on.

Regulatory guidance on ascertaining occupational doses is published in CNSC REGDOC 2.7.2, Dosimetry, Volume I: Ascertaining Occupational Dose. This document provides regulatory expectations for ascertaining the committed effective dose and intake monitoring/dosimetry methods.

"Section 13 of the Radiation Protection Regulations (RPRs) requires that every licensee ensure the following effective dose limits are

not exceeded:..."

Does Canada intend to harmonize the dose limits in the RPRs with those of IAEA GSR-3? If the answer is ‘yes’, what is the timeframe to implement such amendments?

The CNSC most recently revised the RPRs in November 2020. No changes were made to the effective dose limits prescribed in section 13 at that time.

The CNSC continues to review the regulatory framework to seek opportunities to modernize, taking into account international benchmarks such as the IAEA Safety Standards. The next review of the CNSC’s RPRs is anticipated to occur in 2025/26.

"Some of the key amendments to the RPR made during the reporting period include: • a revision to the equivalent dose limit for the lens of an eye for a NEW from 150 mSv to 50 mSv in a one-year dosimetry period"

Could the CNSC elaborate on the reason the new amendments to the RPR deviate from the ICRP (International Commission on Radiological Protection) recommended equivalent dose to the lens of the eye (20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year)?

The CNSC most recently revised the RPRs in November 2020. The revisions to the RPRs were based on significant regulatory analysis and stakeholder consultation.

The CNSC originally proposed two changes to the equivalent dose limit for the lens of the eye. The first was to lower the current equivalent dose limit for a NEW from 150 mSv to 50 mSv in a one-year dosimetry period. The second was to introduce a new equivalent dose limit for a NEW for the lens of the eye of 100 mSv in a five-year dosimetry period (which would align with the effective dose limits in the RPR).

Stakeholders provided extensive feedback on these proposed amendments, including their general agreement with the proposed dose limit for a one-year dosimetry period. However, stakeholders had concerns about the science that underpins the ICRP recommendation for a five-year dose limit and cited implementation challenges, including concerns about the current lack of licensed dosimetry for measuring lens of eye dose in Canada. Stakeholders also expressed significant concerns about the costs of implementing and managing exposures to the lens of an eye below the average dose of 20 mSv per year, especially in high-hazard work in NPP refurbishments. Some stakeholders indicated that in certain situations, a five-year limit could restrict worker employment.

Based on an analysis of all available information, the CNSC did not move forward with the proposed five-year dose limit for the lens of an eye for NEWs.

It is the CNSC’s position that the latest regulatory revision enhances worker protection by lowering the equivalent dose limit for the lens of an eye for a NEW in a one-year dosimetry period. It addresses stakeholder concerns regarding impacts on worker employment, and it will give industry and academia time to further research the science that supports the ICRP’s recommendations. In addition, it will allow time for licensed lens of the eye dosimetry to be developed in Canada and for practical implementation challenges to be addressed.

Licensees are expected to have measures in place in their radiation protection programs to manage cumulative doses to the lens.

Future amendments to the equivalent dose limit for the lens of an eye for NEWs, including the adoption of a five-year dose limit, will be considered during the next review of the RPR, scheduled in 2025/26.

Could the CNSC elaborate further on any existing requirements to assess the dose to NPP workers from neutron fields?

In case such requirements exist, could the CNSC specify for which type of facilities such monitoring is required?

As per the requirements of the CNSC’s RPRs, every licensee must ascertain and record the magnitude of exposure to radon progeny as well as the effective dose and equivalent dose received by and committed to every person who performs duties in connection with any activity that is authorized by the NSCA or is present at a place where that activity is carried on. As such, workers who are occupationally exposed to neutron radiation must be monitored and their doses ascertained and recorded. This applies to all licensed activities and facilities under the CNSC’s jurisdiction.

Regulatory guidance on ascertaining occupational dose can be found in CNSC REGDOC 2.7.2, Dosimetry, Volume I: Ascertaining Occupational Dose. Section 4.6 of this REGDOC covers regulatory guidance regarding dosimetry for neutron exposures.

Regarding the general and specific requirements during operations of nuclear power plants (NPPs) related to protecting people and the environment:

Q: What are the specific measures to protect the environment, as opposed to the protection of the population?

The CNSC’s environmental protection framework has requirements and specific measures that licensees must implement to ensure the protection of the environment. This is elaborated in CNSC REGDOC-2.9.1, Environmental Principles, Assessments and Protection Measures. Examples of specific protective measures include both control and monitoring of effluents and emissions, protection and monitoring of groundwater, environmental risk assessment (ERA), and establishment of an environmental management system that includes, among other things, provisions for environmental emergency preparedness.

For Class I nuclear facilities and uranium mines and mills, the licensee must conduct an ERA in accordance with CSA N288.6, Environmental risk assessments at nuclear facilities and uranium mines and mills. The ERA must be completed in a systematic, scientifically defensible manner that identifies, quantifies and characterizes the risk posed by releases of nuclear and hazardous substances and physical disturbances (stressors) on representative human and non-human biota. The end product of an ERA is a determination of the risk to human and non-human biota.

The ERA results provide feedback into a licensee’s monitoring programs (e.g., recommending any changes to the monitoring program to focus on new issues). The licensee is required to implement an effluent monitoring program and an environmental monitoring program to address the results and conclusions of the ERA. An effluent monitoring program collects and analyzes samples of treated water/air at the point of release/final point of control. Results are compared against regulatory licence limits and estimated releases are used as source-terms for the ERA. An environmental monitoring program collects and analyzes samples in the receiving environment, such as water, sediment, vegetation, soil, air, groundwater, and biota (such as fish). The results are compared against local/regional background, protective environmental quality guidelines, and ERA predictions.

The CNSC most recently revised the RPRs in November 2020. The revisions to the RPR were based on significant regulatory analysis and stakeholder consultation.

The CNSC originally proposed two changes to the equivalent dose limit for the lens of the eye. The first was to lower the current equivalent dose limit for a NEW from 150 mSv to 50 mSv in a one-year dosimetry period. The second was to introduce a new equivalent dose limit for a NEW for the lens of the eye of 100 mSv in a five-year dosimetry period (which would align with the effective dose limits in the RPR).

Stakeholders provided extensive feedback on these proposed amendments, including their general agreement with the proposed dose limit for a one-year dosimetry period. However, stakeholders had concerns about the science that underpins the ICRP recommendation for a five-year dose limit and cited implementation challenges, including concerns about the current lack of licensed dosimetry for measuring lens of eye dose in Canada. Stakeholders also expressed significant concerns about the costs of implementing and managing exposures to the lens of an eye below the average dose of 20 mSv per year, especially in high-hazard work in nuclear power plant refurbishments. Some stakeholders indicated that in certain situations, a five-year limit could restrict worker employment.

Based on an analysis of all available information, the CNSC did not move forward with the proposed five-year dose limit for the lens of an eye for NEWs.

It is the CNSC’s position that the latest regulatory revision enhances worker protection by lowering the equivalent dose limit for the lens of an eye for a NEW in a one-year dosimetry period. It addresses stakeholder concerns regarding impacts on worker employment, and it will give industry and academia time to further research the science that supports the ICRP’s recommendations. In addition, it will allow time for licensed lens of the eye dosimetry to be developed in Canada and for practical implementation challenges to be addressed.

Licensees are expected to have measures in place in their radiation protection programs to manage cumulative doses to the lens.

Future amendments to the equivalent dose limit for the lens of an eye for NEWs, including the adoption of a five-year dose limit, will be considered during the next review of the RPR, scheduled in 2025/26

The table titled Occupational dose summary for Canadian NPPs, 2019 to 2021, should be read as follows:

• Total collective dose in person-mSv is the sum of the collective dose from routine operations plus the collective dose from outages.
• For a given row, if you add the value in column 4 (collective dose from routine operations) to the value in column 5 (collective dose from outages), you will get the resultant total collective dose in column 6.

The last column on the right-hand side is for the maximum individual effective dose to the most exposed worker in a given year for each facility.

Canadian NPPs have separate DRLs for gaseous emissions and for liquid effluents. During the reporting period, the gaseous and liquid releases from Canadian NPPs were a small fraction of their corresponding DRLs.

Environmental impact levels are also known as environmental action levels. Historically, environmental action levels are set at 10% of the DRL. Recently, environmental action levels have been developed in accordance with the guidance and requirements in CSA N288.8-17 Establishing and implementing action levels for releases to the environment from nuclear facilities. This approach consists of gathering actual effluent data, determining the upper value of normal operations using a statistical analysis, and applying a factor above the upper value of normal operations to calculate the environmental action level.

What are the criteria (environmental measurement, calculated dose…) that would lead the responsible authority to order/recommend the ingestion of iodine?

How is this decision communicated to the people concerned?

The CNSC is currently updating REGDOC-2.10.1, Nuclear Emergency Preparedness and Response, Version 2 in view of the application to SMRs and advanced reactor technologies.

Applicants make the case for the size of the emergency planning zones. Information is provided in sections 3.3.5 and 4.6.1 of REGDOC-1.1.1, Site Evaluation and Site Preparation for New Reactor Facilities, Version 1.2.

Additional information is provided in section 2.10 of DIS-16-04, Small Modular Reactors: Regulatory Strategy, Approaches and Challenges.

With regard to p.158, if each Province defines its modalities of stockpiling and (pre)distributing iodine thyroid-blocking (ITB) agents:

(1) Please confirm if there is any national guideline that applies to all Provinces.

(2) Is there any national system to consolidate data about the stockpile/(pre)distribution status of ITB agents from each Province? If so, which authority is in charge?

The administrative framework of the Federal Emergency Response Plan (FERP) and the Federal Nuclear Emergency Plan (FNEP) bring together the resources and expertise available across the federal government to respond to nuclear emergencies in federal jurisdiction or support provinces in their response.

National guidelines for protective actions, such as Health Canada’s Generic Criteria and Operational Intervention Levels for Nuclear Emergency Planning and Response, are intended to assist federal and provincial emergency response authorities on choosing appropriate protective actions to protect public health and safety. Intervention levels in such guidelines are used to inform decisions on which measures are necessary to protect the public during a nuclear emergency. These guidelines are based, in part, on advice from international organizations such as the IAEA and the ICRP and are found on the Government of Canada’s publications website.

National requirements would also include CNSC REGDOC-2.10.1, Nuclear Emergency Preparedness and Response. This REGDOC requires licensees to provide the necessary resources and support to provincial and municipal authorities to do the following:

• ensure that a sufficient quantity of ITB agents is pre-distributed, to all residences, businesses and institutions within the designated plume exposure planning zone, together with instructions on their proper administration; and,
• ensure that a sufficient quantity of ITB agent is pre-stocked and available within the designated ingestion control planning zone; this inventory of ITB agents shall be located so that it can be efficiently obtained by, or provided to, members of the public when required.

The REGDOC has additional requirements related to KI pills such as maintaining the pre-distributed and stockpiled pills within the expiry date.

As NPPs in Canada are only located in two provinces (Ontario and New Brunswick), the REGDOC only applies to the licensees in those provinces. Ontario also falls in the emergency planning zones for two NPPs in the USA. Emergency Management Ontario is also responsible to work with the appropriate municipalities in the emergency planning zones of the USA reactors and have pre-distributed ITB in the appropriate areas.

There is no national system to consolidate data about stockpile/pre-distribution status of ITB as it is provincial jurisdiction. For example, Emergency Management Ontario works with the Ministry of Health, OPG and the appropriate municipalities in Ontario to pre-distribute ITB agents within 10 km of the NPP and ensure that ITB agents are stockpiled in sufficient quantities and can be distributed in an emergency. This aligns with the requirements in REGDOC-2.10.1. The majority of Canadian provinces do not require ITB agents as NPPs are not located in those provinces nor are they in the emergency planning zones for reactors in the USA.

With regard to p.158:

(1) in case of urgent distribution of ITB, is there any guideline to include the following procedures?

- screening people for contraindication/precautions

- checking parental consent when distributing KI to minors

- managing side effects

(2) Are these procedures different in each Province?

(1) The process for deciding when to direct the ingestion of iodine is broadly laid out in the Provincial Nuclear Emergency Response Plan (PNERP) Master Plan for the Province of Ontario. The technical criteria for intervention levels are defined in Annex E of that plan: if it is believed that the public would get more than 50 mSv of equivalent dose to the thyroid gland, the provincial authorities would direct them to take a KI pill.

The Ontario Provincial Emergency Operations Centre uses dose modelling to estimate radiation doses to the public to support that decision-making. In the extremely unlikely event of a fast-moving emergency where the province would not have time to complete modelling, the decision would be based on the situation at the NPP. This is illustrated in the PNERP Implementing Plan for Darlington (Table 4.2) and is the same for Bruce and Pickering.

The province would not depend on environmental measurements to make this decision because, by the time those measurements would be received, it would be too late. KI pills need to be taken just before exposure to be the most effective.

The direction would be communicated to the public in the affected area using the AlertReady system. Instructions would be sent to the mobile phones of everyone in the area, as well as through broadcast-intrusive alerts over radio and TV. More information on public alerting can be found in section 6.2 of the PNERP Implementing Plan for Darlington. Again, these arrangements are the same for Bruce and Pickering.

(2) In New Brunswick, the New Brunswick Technical Advisory Group would determine when to recommend the public to take a KI pill, following the Health Canada Generic Criteria and Operational Intervention Levels for Nuclear Planning and Response.

With regard to p.158, in case of KI pre-distribution:

(1) Is there any guideline to include the following procedures for KI pre-distribution?

- For institutions, the target locations and how to manage each location;

- For residents, how to exchange, return and receive additional KI?

(2) Please explain how the procedures are being established.

KI pills are required to be pre-distributed to all residents and institutions within 10 km of an NPP in accordance with CNSC REGDOC-2.10.1. All residents, institutions and individuals working within the 50 km ingestion planning zone may also order KI pills (free of charge), through www.preparetobesafe.ca in Ontario. In New Brunswick, individuals and institutions can order KI pills, free of charge, by contacting the NB Emergency Management Organization. The province and designated municipalities do have some KI pills available at pharmacies that can be obtained by members of the public. The CNSC does not provide guidance to the province or municipalities on how to identify locations for KI pills to be stockpiled.

To replace expired KI pills that have been pre-distributed within 10 km, provincial and municipal authorities, with support from the licensee, coordinate this replacement as a requirement of REGDOC-2.10.1. Anyone ordering KI pills through www.preparetobesafe.ca, are informed to reorder KI pills once the expiry is reached, and additional orders can be placed through the website at any time.

Health Canada participates in two working programs to share emergency preparedness expertise. There is a Statement of Intent between Health Canada and the USA's National Nuclear Security Administration, Department of Energy. The two organizations meet yearly to update and exchange information.

There is also the Nuclear/Radiation Communications Working Group hosted by the US Environmental Protection Agency that brings together professionals working in the nuclear/radiation emergency response communication preparedness areas. The group offers a platform to brainstorms ideas and fill gaps. The working group offers members the opportunity to learn, collaborate and network with a diverse group of experts across various disciplines. The quarterly, webinar-based meetings typically focus on one topic that is presented by a subject matter expert and discussed afterwards.

Chapter 18 of the national report (page 175) describes the construction of SMRs and micro-reactors.

(1) Which regulatory documents does CNSC apply to assess the NPP design documents?

(2) Please explain whether the assessment criteria for the existing NPP design documents and licensing process are applied to SMRs and micro-reactors.

The following CNSC documents are used to assess NPP designs:

REGDOC-1.1.2, Licence Application Guide: Guide to Construct A Reactor Facility, Version 2

REGDOC-2.3.1, Conduct of Licensed Activities: Construction and Commissioning Programs

REGDOC-2.4.2, Probabilistic Safety Assessment (PSA) for Reactor Facilities, Version 2

REGDOC-2.5.1, General Design Considerations: Human Factors

REGDOC-2.5.2, Design of Reactor Facilities

RD-367: Design of Small Reactor Facilities.

The CNSC uses existing regulatory documents developed for NPPS using a graded approach for SMRs. The CNSC is continuously improving and modernizing the regulatory framework and continues to ensure it remains technology-neutral and flexible for innovative technologies such as SMRs.

Paragraph “Modernization of design for operating NPPs” notes that during a PSR, the licensee determines reasonable and practical modifications to improve facility safety to a level approaching that described in current standards. Corrective actions, including design and other safety improvements, are also prioritized. Typically, new standards are more stringent than those used in the design of a nuclear facility.

How is the adequacy (reasonableness limits) of such modification measures determined?

The current version of REGDOC 2.5.2, although principally written for water-cooled reactors, allows the review of other reactor designs. If other reactor technologies are reviewed, they are subject to the safety objectives, high-level safety concepts and safety management requirements associated with REGDOC-2.5.2.

It is foreseen that, in the future updated version of REGDOC 2.5.2, particular attention will be given to ensure that it is further optimized to support the review of non-water-cooled type of reactors while remaining objective-based.

It is stated that "The use of natural uranium in CANDU reactors results in fuel bundles – either fresh or irradiated – that cannot lead to a critical state either in air or light water. Therefore, a criticality accident cannot occur when CANDU fuel is stored in an irradiated fuel bay or dry storage facility."

What measures are taken in the design and operation of the dry storage facility to ensure the irradiated fuel is cooled?

Have you considered the French feedback on stress corrosion discovered on safety injection circuits of pressurized water reactors (IRS number 9063)? If yes, how was it considered?

Have specific inspections been carried out?

The CNSC requires, through licence conditions, the implementation and maintenance of programs to ensure safety, such as programs for safety analysis, fitness for service, and environmental protection. The CNSC performs oversight of the programs through compliance activities. For information related to the management of spent fuel and radioactive waste in Canada, please see Canada's most recent National Report to the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management. The report can be accessed from the CNSC public website.

Long term integrity of the fuel during dry storage has been studied and reported in the nuclear waste safety report. Used fuel retrievability is incorporated into the dry fuel storage design. Fuel cladding integrity is analyzed to exceed 10E6 years.

Entry conditions for SAMGs may vary slightly between Canadian NPPs, however; here are some general entry conditions for SAMGs:

(1) Deterioration of the existing accident condition, that may be directed by the emergency management organization (EMO)

(2) For a reactor unit with heat transport temperature greater or equal to 90ºC, a reactor inlet header saturation margin that is in the superheated region for greater than 15 minutes and either moderator level that is below the top of the highest channels or radiation levels that reach certain levels at designated measurement points

(3) For a reactor unit with heat transport temperature less than 90ºC, the sub-cooling margin is 0ºC for greater than 15 minutes and either radiation levels are indicative of significant fuel failures at designated measurement points or the EMO or shift manager directs entry to SAMG

(4) For irradiated fuel bays, based on gamma dose-rate at designated measurement points, low water levels or advice from the SAMG technical support group

For entry into EMEGs, the entry condition is the loss of all AC power (i.e., Class IV power (grid), Class III power (standby generators) and emergency power) to the NPP. It should also be noted that EME may be deployed at the discretion of the EMO to help mitigate other events if deemed appropriate.

REGDOC 2.5.2 Section 7.8 “Equipment environmental qualification” restricts the scope of environmental qualification to design-basis accidents (DBAs). However, it goes on to state: “Equipment and instrumentation credited to operate during design extension conditions (DEC) shall be demonstrated, with reasonable confidence, to be capable of performing their intended safety function(s) under the expected environmental conditions. A justifiable extrapolation of equipment and instrumentation behaviour may be used to provide assurance of operability, and is typically based on design specifications, environmental qualification testing, or other considerations.”

In addition, CSA Group standard N290.13, Environmental qualification of equipment for nuclear power plants, which is part of the licensing basis for Canadian NPPs, restricts environmental qualification to DBA conditions. There is however an informative Annex B that provides guidance on equipment survivability assessments for DEC.

Thus, the scope of regulation for environmental qualification in Canada is a deterministic approach under DBA conditions only. Note that DEC and BDBAs are both considered to be severe accidents and would fall into the category discussed in the Canadian report on page 190. DECs and BDBAs are subject to a probabilistic approach (e.g., survivability assessment), which is not expected to be as rigorous as the application of environmental qualification within the design basis. The aim of survivability assessments is to obtain reasonable assurance that the equipment will survive to perform its function in the severe accident timeframes.

Therefore, since environmental qualification is only considered for DBA conditions, the traditional systems are already qualified as they must be per design requirements for DBA. Harsh environmental conditions expected in severe accidents are subject to survivability assessment.

Yes, the CNSC’s simulations of severe accident progression were helpful. For example, the simulations confirmed the effectiveness of EME in impeding the progression of the accident to more serious consequences.

Analytical simulations are also a backbone of licensees' emergency preparedness drills and exercises. For some licensees, simulation informs the role play of the drill and exercise participants. For other licensees, the outcomes from severe accident analysis are used to formulate manual injects into the design of an exercise or drill.