Vol. 151, No. 20 — October 4, 2017

Registration

SOR/2017-199 September 22, 2017

NUCLEAR SAFETY AND CONTROL ACT

Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act

P.C. 2017-1175 September 22, 2017

The Canadian Nuclear Safety Commission, pursuant to section 44 (see footnote a) of the Nuclear Safety and Control Act (see footnote b), makes the annexed Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act.

Ottawa, April 12, 2017

Michael Binder
President of the Canadian Nuclear Safety Commission

His Excellency the Governor General in Council, on the recommendation of the Minister of Natural Resources, pursuant to section 44 (see footnote c) of the Nuclear Safety and Control Act (see footnote d), approves the annexed Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act, made by the Canadian Nuclear Safety Commission.

Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act

Radiation Protection Regulations

1 Section 15 of the Radiation Protection Regulations (see footnote 1) is replaced by the following:

15 (1) The effective dose limits and equivalent dose limits prescribed in sections 13 and 14 do not apply to a person participating in the control of an emergency.

(2) A licensee who requests a person to participate in the control of an emergency shall ensure that the person does not receive an effective dose greater than 50 mSv or an equivalent dose to the skin greater than 500 mSv unless that person is taking an emergency action described in Column 1 of the table to subsection (3).

(3) A licensee who requests a person participate in the control of an emergency shall ensure, if that person takes an emergency action described in Column 1 of the table to this subsection, that the person does not receive an effective dose greater than that described in Column 2 or an equivalent dose to the skin greater than that described in Column 3.

TABLE





Item

Column 1



Action

Column 2

Effective dose
(mSv)

Column 3


Equivalent dose to the skin (mSv)

1

Actions to minimize dose consequences, for members of the public, associated with the release of radioactive material

100

1 000

2

Actions to prevent health effects of radiation that are fatal or life-threatening, or that result in permanent injury

500

5 000

3

Actions to prevent the development of conditions that could significantly affect people and the environment

500

5 000

(4) If, on the request of a licensee, a person takes actions described in more than one item of the table to subsection (3), the licensee shall ensure that the effective dose received by that person does not exceed 500 mSv and that the equivalent dose to the skin received by that person does not exceed 5 000 mSv.

(5) A licensee shall limit the effective dose and equivalent dose received by and committed to persons participating in the control of an emergency to as low as is reasonably achievable, social and economic factors being taken into account.

(6) A licensee shall notify as soon as feasible the person who received the dose of radiation and the Commission in the event that the licensee becomes aware that any of the dose limits prescribed in subsection (2), (3) or (4) may have been exceeded.

(7) A licensee shall not request that a pregnant woman participate in the control of an emergency.

(8) The dose limits prescribed by subsections (2), (3) and (4) and sections 13 and 14 may be exceeded by a person who acts voluntarily to save or protect human life.

2 The portion of section 16 of the Regulations before paragraph (a) is replaced by the following:

16 When a licensee becomes aware that a dose of radiation received by or committed to a person or an organ or tissue may have exceeded an applicable dose limit prescribed by section 13 or 14, the licensee must

3 Section 17 of the Regulations is replaced by the following:

17 When the Commission or a designated officer authorized under paragraph 37(2)(h) of the Act authorizes the return to work of a person referred to in section 16, the authorization may specify conditions to protect the health and safety of the person.

Class I Nuclear Facilities Regulations

4 Paragraph 3(d) of the Class I Nuclear Facilities Regulations (see footnote 2) is replaced by the following:

5 The Regulations are amended by adding the following after section 8:

Periodic Safety Reviews

8.01 (1) Every licensee who is licensed to operate a nuclear power plant must conduct a periodic safety review of the nuclear power plant at an interval specified in the licence.

(2) For the purposes of subsection (1), nuclear power plant means a nuclear facility consisting of any fission-reactor installation that has been constructed to generate electricity on a commercial scale.

Uranium Mines and Mills Regulations

6 Subparagraph 3(b)(v) of the Uranium Mines and Mills Regulations (see footnote 3) is replaced by the following:

Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission)

7 Item 24 of Part 3 of the schedule to the Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission) (see footnote 4) is replaced by the following:

Item

Column 1

Provision

Column 2

Short-form Description

Column 3

Category

24

15(2)

Failure to limit radiation doses to a person participating in the control of an emergency

B

24.1

15(3)

Failure to limit radiation doses to a person taking a specific action during the control of an emergency

B

24.2

15(4)

Failure to limit radiation doses to a person taking more than one specific action during the control of an emergency

B

24.3

15(5)

Failure to limit radiation doses to persons participating in the control of an emergency to a level as low as is reasonably achievable

B

24.4

15(6)

Failure to notify as soon as feasible the Commission after a radiation dose limit is exceeded

B

24.5

15(7)

Requesting a pregnant woman participate in the control of an emergency

B

Coming into Force

8 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

On March 11, 2011, a magnitude 9.0 earthquake struck off the coast of Japan. The earthquake and the resulting tsunami caused the loss of thousands of lives and destroyed half a million homes in Japan. They also caused an accident at TEPCO’s Fukushima Daiichi nuclear power plant.

In response, the Canadian Nuclear Safety Commission (CNSC) launched a review of all major nuclear facilities in Canada. The review confirmed the facilities’ ability to withstand and respond to potential external events, such as earthquakes. A comprehensive review of Canada’s nuclear regulatory framework by the CNSC’s Fukushima Task Force also concluded that the framework is strong, comprehensive, and effectively applied to the whole range of nuclear power plant conditions, including severe accidents. However, the Task Force identified a series of recommendations to further enhance the safety of Canadian nuclear facilities.

Background

The CNSC regulates the use of nuclear energy and materials to protect the health, safety, security and the environment; to implement Canada’s international commitments on the peaceful use of nuclear energy; and to disseminate objective scientific, technical and regulatory information to the public. Before any person or company can prepare a site for, construct, operate, decommission or abandon a nuclear facility, or possess, use, transport or store nuclear substances, it must obtain a licence issued by the CNSC.

These activities are regulated in accordance with the Nuclear Safety and Control Act, which establishes the CNSC’s authority to set regulatory requirements for all nuclear-related activities in Canada. The CNSC’s regulatory framework consists of laws passed by Parliament that govern the regulation of Canada’s nuclear industry, as well as regulations, licences and regulatory documents that the CNSC uses to regulate the industry.

National standards — particularly the consensus standards produced by the CSA Group — set out the necessary elements for acceptable design and performance at a regulated facility or for a regulated activity. Standards are one of the tools the CNSC uses to evaluate whether applicants and licensees are qualified to carry out licensed activities.

The CNSC’s regulatory framework is also informed by international standards and best practices, including the guidance provided by the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), the International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency (IAEA). Alignment with international standards and best practices allows the CNSC to build on the most recent advancements in safety in order to enhance Canadian requirements.

The Fukushima accident highlighted the importance of continued improvements to strengthen and clarify the CNSC’s regulatory framework, and to enhance worker protection and the safety of nuclear facilities in Canada. The CNSC consulted extensively on the recommendations made by the Fukushima Task Force and established an action plan to further strengthen the safety of nuclear facilities.

Objectives

The Class I Nuclear Facilities Regulations, the Uranium Mines and Mills Regulations and the Radiation Protection Regulations have been amended as part of the CNSC’s response to the Fukushima Task Force’s recommendations. The amendments

Description

Clarify dose limits during an emergency

Canada’s Radiation Protection Regulations set limits on the amount of radiation the public and nuclear energy workers may receive during the conduct of licensed activities. The development of recommendations and standards for radiation protection are based on the work of the UNSCEAR, the ICRP and the IAEA.

The Fukushima accident underscored the importance of ensuring that the level of radiation exposure to workers is commensurate with the level of risk needed to undertake actions for the protection of the public, the health of nuclear workers and the environment during the control of an emergency.

Section 15 of the Radiation Protection Regulations lacks clarity to ensure that doses to persons participating in emergency control are optimized and appropriate for the type of action being undertaken during the emergency response. The current Regulations permit effective doses up to 500 millisieverts (mSv) and equivalent doses to the skin up to 5 000 mSv during emergencies.

The Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act (the Regulations)

The changes to section 15 do not address off-site protective actions (for example sheltering and evacuation) to protect the general public in the event of an emergency. Off-site protective actions are addressed by Health Canada as well as provincial and municipal emergency response plans.

The changes clarify and update the current requirements in alignment with international practices, and reflect recent scientific information as well as new guidance on controlling radiation exposure during emergencies. The changes will ensure that doses to workers are minimized.

Update the Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission)

Under the Nuclear Safety and Control Act (NSCA) and its associated regulations, the CNSC applies various compliance and enforcement measures, including the issuance of administrative monetary penalties (AMPs).

AMPs are imposed by the CNSC in response to a violation of a regulatory requirement. The specific provisions against which an AMP may be applied are listed in the schedule of violations to the Administrative Monetary Penalties Regulations (AMPR). An AMP can only be issued for a non-compliance listed in the schedule of violations.

The amendments to section 15 of the Radiation Protection Regulations required consequential amendments to the schedule of violations in the AMPR. Although any violation listed in the AMPR can be subject to an AMP, in the context of the CNSC’s approach to graduated enforcement, other options may be preferred for effecting compliance. Not all cases of non-compliance will result in an AMP, nor will an AMP necessarily be the first enforcement option used in every situation.

Ensure Class I nuclear facility licensees have human performance programs in place, with fitness-for-duty measures to support workers, so they are prepared to effectively respond to nuclear emergencies

The Class I Nuclear Facilities Regulations list the required information to be submitted for licence applications, set requirements for the certification of Class I personnel and record keeping, and establish a 24-month timeline for the regulatory review of whether a site is suitable for the construction and operation of a nuclear facility. Class I nuclear facilities include nuclear reactors, high-energy particle accelerators, as well as nuclear processing plants, fuel fabrication plants and waste disposal facilities.

During the Fukushima event, mitigation and recovery efforts depended largely on the capabilities of workers to carry out tasks. The event demonstrated that proactive training and the management of risks associated with human performance (for example fatigue and stress) are essential to a successful emergency response.

The CNSC’s regulatory framework contains extensive requirements for the structures, systems and components that contribute to the safety of nuclear facilities. However, additional consideration is needed to manage the human components, which are a known source of variability in a nuclear facility’s operation. For example, when performing identical tasks, workers may vary the process used in minor but potentially significant ways. Workers also contribute very positively to safety and performance by using their human characteristics and abilities to detect even small changes in the environment and adjusting their actions accordingly.

A human performance program contains an organization’s processes and procedures that support workers in carrying out their tasks to the desired levels of performance. The program considers and manages the factors that can influence human performance, such as the fitness for duty of workers (workers are physically and mentally capable of performing their duties competently and safely), training, staffing, procedures, processes and the design of equipment. A human performance program includes the need for specific training, practice and rehearsal of emergency tasks, and gives consideration to how extreme conditions may influence human performance.

The Regulations amend section 3 of the Class I Nuclear Facilities Regulations to include a requirement that an application for a licence for a Class I facility contain the proposed human performance program for the activity to be licensed, including measures in place to ensure workers’ fitness for duty. This amendment makes it clear that Class I licensees are expected to have human performance programs to support workers in conducting their daily tasks and being prepared to effectively respond to nuclear emergencies, however improbable.

Ensure that nuclear power plant licensees undertake periodic safety reviews to identify any improvements to ensure continued safe operation

Canadian nuclear power plants have multiple, robust safety systems designed to prevent accidents, and reduce the effects should one occur. All of these systems are maintained and inspected regularly, and upgraded when necessary to ensure plants meet or exceed strict safety standards established by the CNSC. Nuclear power plant licensees conduct regular reviews of their performance to ensure safety is maintained.

The Fukushima accident highlighted the importance of periodically reviewing nuclear power plant safety against modern codes and standards to identify possible safety improvements.

The Regulations amend the Class I Nuclear Facilities Regulations to require nuclear power plant licensees to carry out a periodic safety review at an interval specified in their operating licence.

A periodic safety review involves an assessment of the current state of the plant, its performance, and the adequacy of the programs, including aging management programs, which are in place to maintain reactor safety. The review’s objective is to determine the extent to which the plant conforms to applicable modern codes, standards and practices, and to identify any factors that would limit safe long-term operation. It is a comprehensive evaluation of the design, condition and operation of a nuclear power plant and is an effective way to determine reasonable and practical improvements to safety until the next review or, where appropriate, until the end of commercial operations. Operating experience in Canada and around the world, new knowledge from research and development activities, and advances in technology are also taken into account. A periodic safety review is complementary to — and does not replace — routine and non-routine regulatory reviews, inspections, or other CNSC compliance and verification activities.

Upon completion of the periodic safety review, the licensee submits an implementation plan as part of their application to renew the licence to operate. The implementation plan lists the identified safety improvements committed in a schedule for completion. When the new licence is issued, it refers to the commitments made in the implementation plan. The licensee’s progress in meeting the commitments of the plan is then included in the CNSC’s annual nuclear power plant compliance report to allow for public input.

Canadian licensees have recently performed reviews equivalent to periodic safety reviews to assess the safety of their operations, facilities and equipment prior to major projects, such as refurbishing a reactor. The reviews have been effective in achieving safety improvements. The application of periodic safety reviews in Canada represents an evolution of a current practice, as opposed to the adoption of a new one.

Adopting these safety reviews on an ongoing basis will ensure the continued enhancement of nuclear power plant safety and alignment with national and international codes, standards, and practices.

Modernize the Class I Nuclear Facilities Regulations and the Uranium Mines and Mills Regulations to require licensees to have a management system

In 2009, the CNSC and the Canadian nuclear industry agreed to move from a requirement for a quality assurance program to a management system, in keeping with the International Atomic Energy Agency (IAEA) guidance for the nuclear industry and the recent updates to the CSA Group’s nuclear standards. The CSA N286 standard, CSA N286-12, Management system requirements for nuclear facilities, incorporates and builds on the IAEA’s safety standards, and the CNSC is in the process of implementing it for all Class I and uranium mines and mill licensees. This standard has been adopted as the term of reference in the Canadian nuclear industry for several years, and aligns with international best practices for nuclear facilities.

The Fukushima accident demonstrated that the decisions made under normal operations should be primarily focused on safety, and that having a management system would ensure that the organization’s various programs are integrated to support those decisions.

A management system integrates the organization’s various programs, including those for quality assurance, human performance, and security, so that safety is not compromised by other requirements or demands. The management system also ensures the promotion of a safety culture, the regular assessment of safety performance and the application of lessons learned from experience.

The Class I Nuclear Facilities Regulations and the Uranium Mines and Mills Regulations currently require the submission of a proposed quality assurance program as part of a licence application to the CNSC. The Regulations update the section on general requirements for licence applications in both the Class I Nuclear Facilities Regulations and the Uranium Mines and Mills Regulations from “quality assurance program” to “management system.” All Class I nuclear facilities and uranium mines and mills currently have management systems in place as a condition of their licence to operate.

This amendment makes it clear that licensees of Class I nuclear facilities and uranium mines and mills are expected to establish management systems that give primary consideration to safety. The amendment brings the regulations up to date with the Canadian nuclear industry’s current best practice.

“One-for-One” Rule

The Regulations do not increase the administrative costs of licensees or applicants.

Dose limits during an emergency

Limiting doses to persons given the type of action being undertaken during the emergency response enhances worker protection. The requirement to report any exceedance of dose limits remains unchanged. As a result, there are no incremental administrative costs.

Human performance program

Human performance is a key contributor to the safety and security of nuclear facilities. This requirement is formalizing current practice because this information is currently supplied as part of a licence application.

Periodic safety review

Nuclear power plant licensees have already completed the equivalent of a periodic safety review and submitted the information to the CNSC. The information is submitted as part of the application to renew the licence to operate. There are no new associated costs with the amendment to the Class I Nuclear Facilities Regulations because the requirement to demonstrate the safety case for the plant over the proposed licensing period remains unchanged. The periodic safety review is an established method for identifying safety improvements for aging power plants, and has also been shown to be an effective means of achieving these improvements.

Management system

The current regulations are out of date because they require a quality assurance program, which is one element of an overall management system. By considering the implications of all actions with regard to safety as a whole, a management system ensures that safety is not compromised. The change to require a management system will modernize the regulations and reflect current national and international best practices. Licensees already supply this information, so there are no administrative costs associated with this change.

Small business lens

The small business lens does not apply to this proposal. No small businesses are impacted by the proposal, so there are no costs to small businesses.

Consultation

Initial consultation

The CNSC responded to the Fukushima nuclear accident by launching a review of all major nuclear facilities in Canada. The CNSC Fukushima Task Force Report identified a series of recommendations aimed at further enhancing the safety of nuclear facilities in Canada.

The CNSC proposed an action plan to implement the recommendations and embarked on a series of consultations with the public and stakeholders to seek their input. The action plan was also subject to two independent evaluations: one by the IAEA Integrated Regulatory Review Service mission, and the second by an external advisory committee.

The CNSC consulted further with stakeholders by publishing two discussion papers in 2013: DIS-13-01, Proposals to Amend the Radiation Protection Regulations, and DIS-13-02, Proposed Amendments to Regulations Made Under the Nuclear Safety and Control Act. Notice of the consultations was also posted on the Government of Canada’s Consulting with Canadians website. The CNSC received 26 comments from 16 stakeholders on the draft Regulations.

Stakeholders were encouraged to voice their views on the potential impacts of the proposed regulatory initiatives, including any administrative burden or cost (as well as any possible reduction in burden) on businesses.

The comments came from a broad range of stakeholders representing government, industry associations and organizations, the uranium mining and exploration sector, health care facilities and hospitals, as well as nuclear power plants and research reactors.

Dose limits during an emergency

The CNSC received 25 comments from 12 stakeholders on proposed amendments to section 15 (Emergencies) of the Radiation Protection Regulations. Stakeholders generally supported the proposed changes to the section on emergencies, although many licensees recommended that the terminology used align with what is used internationally. The CNSC considered the feedback received and the lessons learned from the Fukushima accident in the drafting of the Regulations. The CNSC is also developing accompanying guidance to ensure regulatory expectations are clear.

Human performance program

Class I nuclear facility licensees felt that it was not necessary to include human performance and fitness for duty in regulations because they already have human performance programs in place, commensurate with the risk for the licensed activity. Licensees felt the CNSC already has the authority to set this requirement in licences and that the CNSC is developing regulatory documents on various aspects of human performance.

The CNSC is proposing to set the high-level requirement for a human performance program in regulations because it is a general requirement for all licence applications for Class I nuclear facilities. The scope of measures to be implemented to ensure workers are fit for duty varies depending on the risk profile of the licensee or licensed activity being performed. Therefore, specific fitness-for-duty assessments may not be justified for some licensees and licensed activities. Since Class I licensees currently provide information on their human performance programs, it is the CNSC’s assessment that there should not be increased costs.

Periodic safety reviews

Nuclear power plant licensees fully supported this requirement. In discussion paper DIS-13-02, the CNSC proposed that periodic safety reviews take place every 10 years. Nuclear power plant licensees felt the 10-year interval should not be specified in regulations and could be worked out through the licensing process. This approach will provide flexibility to coordinate with the reviews with applications for licence renewals. The CNSC agreed and has proposed that the Regulations require nuclear power plant licensees to carry out periodic safety reviews at an interval specified in their operating licence.

Management systems

Licensees of Class I nuclear facilities and uranium mines and mills fully supported the requirement to move from a “quality assurance program” to a “management system,” because the draft Regulations align with current industry practice.

Prepublication consultation

The draft regulations were published in the Canada Gazette, Part I, on October 8, 2016, followed by a 30-day public comment period. During the comment period, 20 comments were received in 6 different submissions from stakeholders that included nuclear power plant operators, a medical isotope producer, and an industry association. No comments were received from Indigenous groups. The comments were posted on the CNSC website for feedback from November 21 to December 19, 2016. No further feedback was received.

Dose limits during an emergency

Overall, there was general support for the proposed changes to section 15 (Emergencies) of the Radiation Protection Regulations. Stakeholders requested more clarity on the proposed new dose limits, which are based on the International Atomic Energy Agency’s General Safety Requirements Part 3. Further information is being drafted for additional guidance to support compliance with section 15, which will be included in a CNSC regulatory document on radiation protection.

During early consultation, stakeholders had requested changing the requirement to “immediately” notify the Commission of dose limits being exceeded during an emergency (what is now subsection 15(6)) to “as soon as practical.” Stakeholders requested clarification on the proposed requirement, as immediate notification would not be practical in certain cases. During an emergency, the overriding requirements are to control the situation and to take measures to minimize impact on the public, workers, and the environment. Reporting requirements should not distract from the control of an emergency. In the drafting of the regulations, “as soon as practical” was considered to be too subjective, and the existing wording in the Radiation Protection Regulations was used when finalizing the text for publication in the Canada Gazette, Part I. Stakeholders repeated their request to change the requirement in their comments on the draft regulations published in the Canada Gazette, Part I. After further consideration, “immediately” was replaced with “as soon as feasible” in subsection 15(6). This language is used in the Packaging and Transport of Nuclear Substances Regulations, 2015, in subsection 36(2). The corresponding short-form description in the Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission) has also been revised to align with new wording of the provision.

Stakeholders requested that subsection 15(7) of the Radiation Protection Regulations, prohibiting pregnant workers from participating in the control of an emergency, be modified to include a dose limit of four millisieverts. With respect to the protection of sensitive populations, such as pregnant women, the CNSC sees no compelling reason for these individuals to be involved in the direct control of an emergency. It is neither expected nor acceptable to subject pregnant workers to potentially elevated doses because of the potential risks to unborn children. The CNSC acknowledges that pregnant workers may play an active role in aiding emergency response, but from a remote and radiologically stable, safe environment where they would continue to be subject to the dose limits prescribed in sections 13 and 14 of the Radiation Protection Regulations. This is captured in subsection 15(7), so it is unnecessary to specify a dose limit. The requirement prohibiting pregnant workers from participating in the control of an emergency therefore remains unchanged.

One licensee asked if the CNSC is considering future changes to dose limits, based on the age or preferential use of older personnel during emergencies. The CNSC is not considering age adjustment for dose limits in emergencies, nor is it drafting guidance to recommend preferential use of older personnel in such circumstances. The system of radiological protection, whether it is applied during normal operations or emergencies, does take into account differences in detriment based on age and sex. However, dose limits are set so that they are age- and sex-neutral and adequately protective of all.

Update the Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission)

Stakeholders noted that the language used in the short-form descriptions in the schedule of violations is different from the provisions in the Radiation Protection Regulations. They were concerned that the differences could cause confusion and result in a penalty being applied based on the language used in the short-form descriptions.

The CNSC believes the new short-form descriptions align sufficiently with the text in the Radiation Protection Regulations. The short-form descriptions do not replace the provisions in the Act or regulations. Section 2 of the Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission) states: “(2) In the event of a discrepancy between the short-form descriptions in the schedule and the provision to which it pertains, the provision prevails.” No changes have been made to the draft regulations, other than to update the short-form description with the notification of exceedance of dose limits, to align with the revised text of subsection 15(6) as noted above.

Human performance program

Stakeholders raised several concerns about the proposed requirement for a human performance program with measures for fitness for duty. The comments focused on the CNSC’s statement that the draft regulations do not impose increased administrative burden. Stakeholders expressed frustration that the Regulatory Impact Analysis Statement published in the Canada Gazette, Part I, did not contain a detailed impact analysis of the costs of implementing future licence conditions.

Administrative burden, as defined by the Red Tape Reduction Act, refers to activities that are necessary to demonstrate compliance with new regulatory requirements, including collecting, processing, reporting and retaining information, and completing forms. It does not include compliance burden resulting from future licence conditions.

The Regulations codify existing practice and do not introduce new requirements. Through their comments, Canadian nuclear facility licensees have confirmed that they currently submit information on their human performance programs and measures that ensure fitness for duty. As a result, they already meet this high-level requirement. The CNSC has therefore determined that the regulatory amendments outlined here would not result in an increase in administrative burden, and the “One-for-One” Rule does not apply.

Further to the above, stakeholders were also concerned that once the high-level requirement for a human performance program becomes law, it will drive a series of new licence conditions that will demand multi-million-dollar investments. Stakeholders referred specifically to the proposed requirement for random drug and alcohol testing, for certain nuclear power plant personnel, included in the draft CNSC regulatory document, REGDOC-2.2.4, Fitness for Duty. Requirements included in CNSC regulatory documents are only mandatory when referenced in a licence condition.

The amendment to the Class I Nuclear Facilities Regulations regarding a human performance program with measures for fitness for duty does not require random drug and alcohol testing and, while it is related, draft REGDOC-2.2.4 does not depend on the regulatory amendment. Although the introduction of random drug and alcohol testing for certain nuclear power plant personnel would undoubtedly have an impact on affected stakeholders, this would be considered as part of the CNSC’s established process for the development of regulatory documents. The impacts of new licence conditions introduced through CNSC regulatory documents are considered on a case-by-case basis. The CNSC has a thorough and transparent public consultation process where stakeholders provide input on the impacts, financial and otherwise, of new requirements. Regulatory documents are presented to the Commission for final approval at a public meeting. The Commission considers input from all stakeholders before making decisions on requirements.

As part of its commitment to continuous improvement, the CNSC published discussion paper DIS-16-05, Human Performance, in October 2016. The CNSC intends to use this feedback to inform its approach to regulating human performance. Before incorporating new requirements or guidance on human performance into its regulatory framework, the CNSC will provide stakeholders with further opportunities to provide feedback on any specific measures that might be proposed.

The CNSC has made no changes to the proposed requirement for a human performance program.

Periodic safety reviews

Stakeholders expressed concern that the definition of a “nuclear power plant” in the Regulations could result in the requirement for periodic safety reviews for small reactors. Stakeholders felt that this would make small reactors uneconomical, and suggested deleting the requirement since it could be included as a licence condition. Stakeholders also raised concerns about the costs associated with carrying out periodic safety reviews and drew a link to the “One-for-One” Rule.

Nuclear power plant licensees have already been completing the equivalent of periodic safety reviews (previously referred to as “integrated safety reviews”) and submitting the information to the CNSC, as part of their application to renew their licence to operate. The requirement to demonstrate the plant’s safety case over the proposed licensing period remains unchanged; therefore, the “One-for-One” Rule does not apply.

The definition of “nuclear power plants” was taken directly from the Nuclear Security Regulations. The CNSC believes it is premature to determine the impacts of periodic safety reviews on small reactors. Efforts are underway to consider how the introduction of small reactors will impact the CNSC’s regulatory framework. The CNSC published discussion paper DIS-16-04, Small Modular Reactors: Regulatory Strategy, Approaches and Challenges in May 2016, and is consulting with stakeholders on this issue. The CNSC has made no changes to the proposed requirement or the definition of a “nuclear power plant.”

Management systems

Stakeholders expressed continued support for replacing “quality assurance” with the term “management system” in the Class I Nuclear Facilities Regulations and the Uranium Mines and Mills Regulations. However, they requested the phrase “including measures to promote and support safety culture;” be deleted from the provision. Stakeholders believe that safety culture should not be singled out because it is firmly embedded in nuclear industry standards, such as CSA Group standard N286-12, Management system requirements for nuclear facilities. They agree that safety culture is an important part of the management system, but it should not be emphasized over other management system requirements.

It is the CNSC’s position that the provision as worded does not isolate safety culture as a separate activity or program. Rather, it emphasizes that safety is the primary consideration over competing goals to ensure the protection of people and the environment. The CNSC has made no changes to the proposed requirement.

The numbering convention for the draft amendments to the Class I Nuclear Facilities Regulations designated the proposed management system provision as paragraph 3(d) and the proposed human performance program as paragraph 3(d.1). Stakeholders interpreted these designations as meaning that the human performance program was a specific requirement to be included in the proposed management system, and were concerned that it would inappropriately raise the profile of one program within the management system. However, “(d.1)” is a temporary designation, and indicates that in the order of items listed in section 3 (general requirements for licence applications), the human performance program requirement will follow the requirement for a management system. Therefore, no changes are necessary.

Transition period to implement regulations

Stakeholders requested a transition period to implement the Regulations. A transition period is not necessary, as the Regulations do not introduce new requirements. Licensees have confirmed through their comments that they already have submitted the information pertaining to their human performance programs and management systems, and nuclear power plant licensees have conducted the equivalent of a periodic safety review.

With respect to the Radiation Protection Regulations, the amendments to section 15 detail the actions that the licensee must take to maintain doses to persons involved in the control of the emergency below applicable dose limits and as low as reasonably achievable. As a result, the requirements only apply in the event of an emergency. Licensees have been aware of the proposed new dose limits in section 15 since 2013. In response to a regulatory request under the Fukushima action plan, licensees were asked to assess the habitability of control facilities during beyond-design-basis accidents and severe accidents. Each licensee demonstrated that it did not require upgrades to control facilities to maintain doses to persons below the new limits. Based on this analysis, the CNSC is confident that licensees are in a position to comply with the Regulations without the need for a transition period.

Rationale

Following the spring 2011 events at Fukushima, nuclear regulators around the world launched a comprehensive review of all their major facilities. As Canada’s nuclear regulator, the CNSC reviewed the capability of nuclear power plants — as well as other nuclear facilities — to withstand conditions comparable to those that triggered the Fukushima accident.

The review confirmed that the Canadian regulatory framework is strong and comprehensive. At the same time, it identified and outlined a series of recommendations, including these regulatory changes.

The Regulations will contribute to the continued safe operation of nuclear facilities and strengthen their ability to adequately deal with potential emergencies, and to protect the health and safety of nuclear workers, emergency responders and the general public.

Implementation, enforcement and service standards

The Regulations come into force on the day they are registered and will be enforced in accordance with the CNSC’s existing enforcement policy. CNSC inspectors regularly verify that licensees are complying with the Nuclear Safety Control Act and its regulations. If a licensee is found to be non-compliant with these Regulations, the CNSC will use a graded enforcement approach to implement corrective measures.

Contact

Brian Torrie
Director General
Regulatory Policy Directorate
Canadian Nuclear Safety Commission
280 Slater Street
P.O. Box 1046, Station B
Ottawa, Ontario
K1P 5S9
Telephone: 613-947-3728
Fax: 613-995-5086
Email: cnsc.consultation.ccsn@canada.ca