Canada Gazette, Part I, Volume 150, Number 41: Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act
October 8, 2016
Nuclear Safety and Control Act
Canadian Nuclear Safety Commission
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
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.
The CNSC regulates the use of nuclear energy and materials to protect the health, safety and security of Canadians 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.
The CNSC proposes to amend the Class I Nuclear Facilities Regulations, the Uranium Mines and Mills Regulations and the Radiation Protection Regulations as part of its response to the Fukushima Task Force's recommendations. The proposals
- update and clarify existing requirements for radiation protection during an emergency with current international standards and practices;
- ensure that human performance and fitness for duty are addressed by licensees of Class I nuclear facilities to support workers in conducting their daily tasks and to be prepared to effectively respond to nuclear emergencies;
- ensure that nuclear power plant licensees undertake regular reviews against modern codes and standards to identify safety improvements to their facilities to ensure their continued safe operation;
- modernize the Class I Nuclear Facilities Regulations and the Uranium Mines and Mills Regulations to reflect the nuclear industry's best practice of placing paramount focus on safety through the implementation of a management system; and
- update the Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission) to reflect the proposed amendments to the Radiation Protection Regulations.
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 proposed Regulations) would
- lower the effective dose limit to 50 mSv and the equivalent dose limit to the skin to 500 mSv;
- specify dose limits for persons taking the following emergency actions:
- actions to minimize dose consequences, for members of the public, associated with the release of radioactive material,
- actions to prevent health effects of radiation that are fatal or life-threatening, or that result in permanent injury, and
- actions to prevent the development of conditions that could significantly affect people and the environment;
- specify dose limits for persons taking more than one of the emergency actions;
- require that the principle of keeping doses as low as reasonably achievable is followed;
- stipulate that pregnant women, including non-nuclear energy workers and off-site emergency personnel, are not to participate in the control of an emergency; and
- specify reporting requirements for when emergency dose limits are exceeded.
The proposed 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 proposed changes would 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 proposed amendments to section 15 of the Radiation Protection Regulations require 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 proposed Regulations would 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 would make 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 proposed Regulations would 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 operation. 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 are then included in the CNSC's annual nuclear power plant compliance report to allow for public input. At the next relicensing, the licensee submits the results of the next periodic safety review, the new implementation plan and a comprehensive report on the completion of the current implementation plan.
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 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 proposed Regulations would 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 will make 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 and bring the regulations up to date with the Canadian nuclear industry's current best practice.
The proposed 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 proposed 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.
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.
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 Web site. The CNSC received 26 comments from 16 stakeholders on the proposed 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 support 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 support the requirement to move from a “quality assurance program” to a “management system,” because the proposed Regulations will align with current industry practice.
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 the proposed regulatory changes.
The proposed Regulations would 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 and enforcement
The Regulations would come into force on the day they are registered. The proposed Regulations would 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 would use a graded enforcement approach to implement corrective measures.
Regulatory Policy Directorate
Canadian Nuclear Safety Commission
280 Slater Street
P.O. Box 1046, Station B
PROPOSED REGULATORY TEXT
Notice is given that the Canadian Nuclear Safety Commission, pursuant to section 44 (see footnote a) of the Nuclear Safety and Control Act (see footnote b), proposes to make the annexed Regulations Amending Certain Regulations Made Under the Nuclear Safety and Control Act.
Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Brian Torrie, Director General, Regulatory Policy Directorate, Canadian Nuclear Safety Commission, 280 Slater St., P.O. Box 1046, Station B, Ottawa, Ontario K1P 5S9 (tel.: 613-947-3728; fax: 613-995-5086; email: email@example.com).
Ottawa, September 29, 2016
Assistant Clerk of the Privy Council
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.
Effective dose (mSv)
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 immediately notify 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:
- (d) the proposed management system for the activity to be licensed, including measures to promote and support safety culture;
- (d.1) the proposed human performance program for the activity to be licensed, including measures to ensure workers' fitness for duty.
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:
- (v) the proposed management system for the activity, including measures to promote and support safety culture;
Administrative Monetary Penalties Regulations (Canadian Nuclear Safety Commission)
|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 immediately notify 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.