Section E

Legislative and Regulatory Systems

E.1 Scope of the section

This section addresses Articles 18 (Implementing Measures), 19 (Legislative and Regulatory Framework) and 20 (Regulatory Body), of the Joint Convention, as well as requirements set out in Articles 19 and 20 of the IAEA Safety Standard GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety. Specifically, this section describes Canada's legislative and regulatory framework, regulatory body and approach to licensing radioactive material.

The NSCA provides the regulatory body with a mandate to establish and enforce national standards in the areas of public health, and safety, and environmental protection. It also establishes a basis for implementing Canadian policy and fulfilling Canada's obligations with respect to the non-proliferation of nuclear weapons. The NSCA sets out a formal system for review and appeal of decisions and orders made by the Commission Tribunal, designated officers and inspectors. It should be noted that the Commission Tribunal has legal authority to hear witnesses, take evidence and control its own proceedings. Additionally, the NSCA empowers the Commission Tribunal to require financial guarantees, to order remedial action in hazardous situations, and to require responsible parties to bear the costs of decontamination and other remedial measures.

E.2 Establishment of the Canadian legislative and regulatory framework

In Canada, matters that relate to nuclear activities and substances are under the jurisdiction of the federal government. NRCan has been charged with setting Canada's nuclear policies, including those concerning radioactive wastes. The Policy Framework for Radioactive Wastes establishes the roles and responsibilities of the federal government and waste producers. In particular, the federal government guides, oversees and regulates radioactive waste producers.

Section 9 of the NSCA states the objects of the NSCA and grants regulatory authority to the Commission Tribunal over the use of nuclear materials. The CNSC's responsibilities include the issuing licences, making regulations and enforcing compliance.

A list of the various federal organizations and acts that relate directly to Canada's nuclear industry are provided in Annexes 1 and 2. A detailed description of the regulatory body, its structure, operations and regulatory activities is provided in Annex 3.

E.3 National safety requirements

The NSCA is the foundation of Canada's regulatory framework, depicted in Figure E.1. All regulations are established based on the NSCA.

E.3.1 Nuclear Safety and Control Act (NSCA)

In the Canadian Parliamentary system, the federal Cabinet - on the advice and recommendation of the appropriate Minister - makes the decision to introduce government legislation into Parliament. The NSCA was passed by Parliament on March 20, 1997, and became law in May 2000. This was the first major overhaul of Canada's nuclear regime since the Atomic Energy Control Act (AECA) and the creation of the Atomic Energy Control Board (AECB), in 1946. The NSCA provides legislative authority for all the nuclear industry developments since 1946. These developments include health and safety standards for new energy workers, environmental protection measures, security regarding nuclear facilities, and public input into the licensing process. The NSCA can be viewed at: nuclearsafety.gc.ca

The NSCA establishes the CNSC as an independent regulatory body, responsible for regulating the use of nuclear material in Canada, including the nuclear fuel cycle. The CNSC is comprised of the Commission Tribunal, which makes licensing decisions, and the CNSC's personnel organization, which prepares recommendations to the Commission Tribunal, exercises delegated licensing and authorization powers and assesses licensee compliance with the NSCA, the Act's associated regulations and licence conditions. The NSCA gives the CNSC the power to make regulations, as shown in section E.3.2 below.

The CNSC's regulatory framework consists of regulations, policies, standards and guides that apply to all nuclear industries, including, but not limited to:

• nuclear power reactors,
• non-power nuclear reactors, including research reactors,
• nuclear substances and radiation devices used in industry, medicine and research,
• the nuclear fuel cycle, from uranium mining through to waste management, and
• the import and export of controlled nuclear and dual-use substances, equipment and technology identified as proliferation risk.

The CNSC's mandate includes the protection of the environment and the health and safety of workers, as well as members of the public. The CNSC discharges these responsibilities through co-operative arrangements with federal and provincial regulators in other fields, such as environmental protection and occupational health and safety.

According to the Parliamentary Directive issued to the CNSC in December 2007, the CNSC now readily takes into account the health of Canadians in regulating the production, possession and use of nuclear substances in order to ensure the necessary protection of the health of Canadians at times when a serious shortage of medical isotopes in Canada or around the world puts the health of Canadians at risk.

The NSCA incorporates stringent regulations to ensure that public health and safety are protected. For example, the NSCA act includes:

• radiation dose limits that are consistent with International Commission on Radiological Protection (ICRP) recommendations,
• regulations that govern the transport and packaging of nuclear materials, and
• specifications for enhanced security at nuclear facilities, including spent fuel dry storage and radioactive waste-management facilities.

The CNSC also has responsibilities under the NLA. The regulatory body conducts environmental assessments under the CEA Act and implements Canada's bilateral agreement with the IAEA on nuclear safeguards verification. As a model of regulatory efficiency, the CNSC oversees the entire nuclear cycle and all aspects of nuclear safety in Canada.

E.3.2 Regulations issued under the NSCA

As illustrated in Figure E.1, there are nine safety-related regulations issued under the NSCA:

1. General Nuclear Safety and Control Regulations,
2. Radiation Protection Regulations,
3. Class I Nuclear Facilities Regulations,
4. Class II Nuclear Facilities and Prescribed Equipment Regulations,
5. Uranium Mines and Mills Regulations,
6. Nuclear Substances and Radiation Devices Regulations,
7. Packaging and Transport of Nuclear Substances Regulations,
8. Nuclear Security Regulations, and
9. Nuclear Non-proliferation Import and Export Control Regulations.

In addition to the safety regulations, the CNSC's Rules of Procedure must also be followed. They apply to the public, licensees, the CNSC's personnel and Commission Tribunal members and govern to the conduct of Commission Tribunal proceedings.

The regulatory regime is flexible about how licensees comply with regulatory requirements.

The regulations require licence applicants to submit information on the environmental effects of their use of both radioactive and non-radioactive hazardous substances. The CNSC then uses this information and consults other federal and provincial regulatory bodies to establish the operating parameters for a specific nuclear facility. Brief descriptions of the regulations are provided below. Note, however, that all of the regulations can be viewed in full at: nuclearsafety.gc.ca

General Nuclear Safety and Control Regulations (GNSCR): outline the information to be included in licence applications; the obligations of licensees and their workers; definitions of prescribed nuclear facilities, equipment and information; and reporting and record keeping requirements. The GNSCR also detail the requirements for an application for a licence to abandon and obligations to provide information on any propose financial guarantees. Note that while these regulations apply to all licensees, including licensees for management of spent fuel and radioactive waste and decommissioning activities. Naturally occurring radioactive materials that are not associated with the development, production or use of nuclear energy are exempt.

Radiation Protection Regulations (RPR): contain radiation protection requirements. They apply to all licensees and others who fall under the mandate of the CNSC. The RPR require the development of action levels, which are proposed by the licensee and subject to the regulatory body's approval. Action levels are not intended to be secondary legal limits, but rather checks for the proper operation of a licensee's radiation protection program.

The dose limits are based on the ICRP's 1991 recommendations and apply to all organizations that fall within the CNSC's mandate. Nuclear energy workers, for instance, must not be exposed to more than 100 millisievert (mSv) over a five-year period or more than 50 mSv in a single year. The dose limit for pregnant nuclear energy workers is much lower at four mSv per year. Member of the public must not be exposed to more than one mSv per year.

Pregnant Nuclear Energy Workers

In 1990, the ICRP published new dose guidelines of two mSv pregnant new energy workers. The Canadian regulatory body planned to initially planned to adopt this new recommendation. The new limit, which was 20 percent of the previous one, drew heavy criticism from members of both the industry and scientific community. It was widely believed that such an extremely low dose would be very difficult to regulate and might restrict employment opportunities for female workers in Canada.

As is always the case when there are proposed changes to regulations, members of the public and industry were given the opportunity to review and comment on them. Public and industry response to the new proposed guidelines for occupational exposure for pregnant workers was made available in September 1992. Five major points were brought forward, of which two were given further consideration: (1) the reassignment of pregnant workers to non-radiation work will present major difficulties and (2) the bioassay programs are not available to show compliance with the intake limit of 0.05 ALI for pregnant nuclear-energy workers. These concerns led to a second public consultation, which took place in October and November 1992.

Three main concerns were raised in this second round of consultation:

1. Dose limits - while participants generally agreed that it is appropriate to set the same dose limit for a fetus as for a member of general public, they deemed the proposed limit to be too low. Many believed that the risk estimates did not warrant a change to the original 10 mSv limit.
2. Compliance - participants suggested that internal dosimetry would first need to be improved before they could demonstrate compliance with the proposed limit, and that contamination surveys, as opposed to a bioassay, could be used to comply with regulations.
3. Other comments - many participants felt that the social and economic impacts of the proposed changes must be examined and believed that a mandatory declaration of pregnancy would be an invasion of workers' privacy.

The CNSC heard these concerns and adopted several participants' internal and external dosimetry suggestions. It also issued a document entitled Revised Proposal for the Dose Limit for Pregnant Radiation Workers, which increased the proposed dose limit from two to four mSv. This change to the proposed dose limit reflects social concerns raised during the consultative process and accepts that a mother may be willing to accept certain risks.

Though no longer consistent with the ICRP-60 recommendation that the public not be exposed to more than one mSv per year, the revised dose limit is consistent with ICRP's conclusion that, in special circumstances, a higher dose could be allowed provided that the average over five years does not exceed one mSv per year. IAEA Safety Series No. 115 also states that, in special circumstances, a dose of up to five mSv in a single year is permissible provided that the average dose over five consecutive years does not exceed one mSv per year.

Provided that both the ICRP and IAEA agree that: (1) five mSv is not a significant conceptus dose; (2) it is reasonable to assume that a child would not be exposed to an additional dose until at least the age of five; and (3) there is scientific rationale to support a dose limit of five mSv, in special circumstances, a balance of pregnancy limit of five mSv would not pose a detectable risk to a conceptus. Therefore, the Canadian regulatory body's adoption of a four mSv dose limit for the balance of pregnancy mitigates both social and scientific considerations of conceptus risk.

Class I Nuclear Facilities Regulations: detail the information licensees need to supply when applying for different types of Class I nuclear facility licences. Licenses are available for stage in the lifecycle of a facility, including site preparation, construction, operation, decommissioning and abandonment. The regulations also address recordkeeping and the certification of reactor operators.

Note that under the NSCA, one of the definitions of a nuclear facility is "a facility for the disposal of a nuclear substance generated at another nuclear facility." A nuclear facility also includes, where applicable, the land on which such a facility is located, a building that forms part of the facility, equipment used in conjunction with the facility and any system for the management, storage or disposal of a nuclear substance. As defined under section 19(a) of the GNSCR, a facility that manages, stores or disposes of radioactive waste and whose resident inventory of radioactive nuclear substances is greater than 10¹⁵ Bq is a prescribed, Class 1 nuclear facility.

Class II Nuclear Facilities and Prescribed Equipment Regulations: specify the requirements for prescribed equipment, including low-energy accelerators, irradiators, radiation-therapy installations and equipment that contains only sealed sources.

Nuclear Substances and Radiation Devices Regulations (NSRDR): apply to all nuclear substances, sealed sources and radiation devices used in Canada that are not included in Class II prescribed equipment. In order to harmonize Canada's regulatory approach for the exemption and clearance of radioactive material with international practices, CNSC amended the NSRDRs to consider the IAEA Basic Safety Standards, as well as the most recent guidance from the IAEA on the concepts of exemption, exclusion and clearance. The amendments, following extensive stakeholder input, were approved by the Governor-in-Council, and subsequently published in the Canada Gazette Part II. The amended regulations came into force on April 17, 2008. Further information on exemption and clearance levels is discussed below.

Exemption and Clearance

Some materials excluded from the regulatory process because the associated radioactivity presents such a low risk that control by regulatory processes is not warranted. There are two such categories: radioactive material that never enters the regulatory control regime; and radioactive material that is released from regulatory control. Note that exempt and cleared waste materials may still be subject to other regulations, e.g. transportation regulations.

Exemption

Radioactive materials in the first category are excluded from regulatory control by a process called exemption. Exempted waste is material that contains less than the exemption quantity as defined in section 1 of the NSRDRs. Although still radioactive from a physical point of view, exempted material can be safely disposed of, applying conventional techniques and systems, without specifically considering its radioactive properties.

Clearance

The release of radioactive material from control, on the other hand, is called clearance. Clearance of radioactive material is a management tool, not a waste classification. There are two forms of clearance: unconditional and conditional clearance. Unconditional clearance levels are defined in the amended NSRDRs.

Packaging and Transport of Nuclear Substances Regulations (PTNSR): are based on the IAEA Safety Standards Series No. TS-R-1, Regulations for the Safe Transport of Radioactive Material, 1996 Edition. The CNSC has been a major participant in the development of the IAEA regulations on the packaging and transport of nuclear materials and has communicated regularly with the federal transportation department - Transport Canada - and major Canadian shippers.

Nuclear Security Regulations (NSR): were amended in November 2006 and now align Canadian nuclear facilities with the IAEA's internationally accepted recommendations. In the development of the NSR, the CNSC gave due consideration to threats to Canada's security and included a number of new physical-protection requirements for security sensitive areas, including:

• enhanced security screening of employees and contractors,
• enhanced identification checks of personnel,
• enhanced screening of persons and vehicles when entering or leaving a protected area,
• heightened protection against forced vehicle penetration of protected areas, and
• enhanced intrusion detection for protected areas.

Uranium Mines and Mills Regulations (UMMR): detail the information needed for licence applications for uranium mines and mills, as well as code-of-practice and record keeping requirements and licensee obligations. Licences are available for each stage of a facility's lifecycle, including site preparation, construction, operation, decommissioning and abandonment. UMMR apply to all uranium mines and mills, including management of mill tailings, but not to uranium prospecting or surface-exploration activities.

Nuclear Non-proliferation Import and Export Control Regulations: govern the import and export of controlled nuclear substances, equipment and information.

Cost Recovery Regulations: enable the CNSC to recover the actual cost of regulating the nuclear industry equitably through licence fees.

E.3.3 Regulatory documents

The NSCA and its associated regulations provide the basis with regard to regulatory expectations and decisions.

In 2007, the CNSC streamlined and improved its regulatory framework. The organization strengthened the roles and responsibilities of the Regulatory Policy Committee (RPC) to align the CNSC's regulatory framework with its overall strategic direction. In September 2007, the Commission Tirbunal approved a revised regulatory framework for the development and approval of regulations and regulatory documents proposed by the RPC.

The following explanatory text is included in all regulatory documents:

• The CNSC develops regulatory documents under the authority of paragraphs 9(b) and 21(1)(e) of the NSCA.
• Regulatory documents clarify NSCA requirements and associated regulations, and are an integral part of the regulatory framework for nuclear activities in Canada.
• Each regulatory document aims to disseminate objective regulatory information to stakeholders, including licensees, applicants, public interest groups and the public, and promote consistency in the interpretation and implementation of regulatory requirements.

Additional information on the CNSC's regulatory documents program is available online at: nuclearsafety.gc.ca

As outlined in the CNSC regulatory policy Regulatory Fundamental (P-299), the CNSC bases its regulatory requirements on industry, national and international standards and best practices, including those of the IAEA. Canada has actively helped the IAEA develop nuclear safety standards and create technical documents, which outline more specific technical requirements and best practices for radioactive waste management and decommissioning.

A list of the CNSC's regulatory documents is included in Annex 3.6.1. Two of these documents are specific to spent fuel and radioactive waste. Other more generic regulatory documents that relate to action levels, decommissioning, environmental protection and public-information programs may also apply to waste management facilities. The CNSC's regulatory documents for radioactive waste and decommissioning are described below. A complete list of regulatory documents is available at: nuclearsafety.gc.ca

Regulatory Policy P-290, Managing Radioactive Waste

The CNSC issued P-290 in July 2004, following extensive consultation with the public, the nuclear industry and other stakeholders. P-290 is discussed in section B.5.

Regulatory Guide G-320, Assessing the Long-Term Safety of Radioactive Waste Management

The CNSC's Regulatory Policy P-290 identifies the need for long-term management of radioactive waste and non-radioactive hazardous waste arising from licensed activities. In December 2006, Regulatory Guide G-320, Assessing the Long-Term Safety of Radioactive Waste Management, was published to assist licensees and applicants assess the long-term storage and disposal of radioactive waste. The Guide (discussed in section B.6) was developed using provincial, federal and international documents, following a pre-consultation with the nuclear industry in Canada.

Regulatory Guide G-219, Decommissioning Planning for Licensed Activities

This document provides guidance on the preparation of plans for the decommissioning of activities licensed by the CNSC. G-219 is described in section F.8.

Regulatory Policy P-319 Financial Guarantees

The CNSC's personnel are considering the development of a revised policy and program for financial guarantees, in consultation with other government stakeholders, which will current international guidance. For more details, please refer to section F.4.3.

E.4 Comprehensive licensing system for spent fuel and radioactive waste management activities

E.4.1 Licensing procedure

Canada maintains the philosophy that licensees is responsible for the safe operations of its facilities. Because licensees make safety related decisions routinely, they must have a robust set of programs and processes in place to ensure adequate protection of the environment, and the health and safety of workers and the public. The CNSC performs regulatory oversight and verifies that licensees and operators comply with regulations.

Figure E.2 - The Licensing Process

Figure E.2 illustrates how an applicant can obtain a licence under the NSCA. First, the applicant must submit either an application for a licence (or letter of intent), or a notification of intent for a project to the CNSC. Applicants must meet general performance criteria, provide information and develop programs in accordance with NSCA regulations to be considered. The CNSC's personnel publish regulatory documents, including policies, guides, standards and notices, which help licensees meet regulatory requirements. Licensees are obligated to adhere to terms and conditions of licence, such as references to standards and decommissioning planning and financial guarantee requirements.

An application for a CNSC licence, including renewals or amendments, may be subject to other legislation and regulations. For example, an Environmental Assessment (EA) under the CEA Act may be required to analyze potential environmental, physical and socio-economic impacts. Note that there are opportunities throughout the EA process for public consultations. The range of stakeholder consultations is determined by possible the environmental impacts and the size and complexity of the project.

Only after positive decision is made on the EA (if one is required) may the Commission Tribunal proceed with making a licensing decision. The Commission Tribunal holds public hearings to consider licence applications for major facilities (see section E.4.3). Under section 37 of the NSCA, the Commission Tribunal can delegate the responsibility for issuing certain types of licenses - other than Class I licenses and uranium mines and mills - to persons who have been identified as a Designated Officer (DO), which are defined under the legislation. This can include various types of licenses, including radioactive waste management facilities that are not defined as Class I nuclear facilities. When a DO is delegated this responsibility, no public hearing occurs, unless the DO refers the decision back to the Commission Tribunal, using a risk based approach. In this case, the Commission Tribunal will evaluate the need to conduct a public hearing, as part of its decision making process.

The CNSC administers its licensing system in cooperation with other federal and provincial government departments and agencies that work in areas such as health, environment, transport and labour.

Once a licence is issued, the CNSC's personnel are responsible for administering the Commission's decision, including the requirement to develop and implement a compliance verification program (see section E.6.3) to ensure that licensees continue to meet their legislative and licence obligations.

E.4.2 Process assessment of a licence application

Early communication with the CNSC can help applicants develop a good understanding of the licensing process, regulatory requirements for spent fuel and radioactive waste management facilities and information to be submitted in support of a licence. Early communication also enables the CNSC to develop a regulatory review, which ensures that qualified personnel are available to carry out the application review.

Figure E.3 - The Lifecycle of the CNSC's Licensing Approach

The management of spent fuel, radioactive waste management and uranium mine/mill waste are regulated during their entire lifecycle - from site preparation, construction and operation to decommissioning and, finally, abandonment. Each phase requires a separate licence.

Licence Application

For a new licence, the regulations require applicants to submit comprehensive information on: their policies and programs, the design and components of the proposed facility, the manner in which the facility is expected to operate, facility operating manuals and procedures and any potential impacts on the site or surrounding environment. The design must be such that emissions from the facility meet strict limits under normal operating and upset conditions, as applicants are required to identify the manner by which a facility may fail to operate correctly, predict the potential consequences of such a failure and establish specific engineering measures to mitigate the consequences to tolerable levels. Those engineering measures may include, but are not limited to, multiple barriers to prevent the escape of noxious material. Many of the analyses of potential accidents are complex, covering a very wide range of possible occurrences.

The CNSC's personnel rigorously review all submissions, using existing legislation and the best codes of practice and experience available in Canada and around the world, to ensure regulatory requirements are met. The expertise of the CNSC's personnel covers a broad range of engineering and scientific disciplines. Considerable effort is also spent reviewing the analyses to ensure that predictions are based on well-established scientific evidence and defences meet defined standards of performance and reliability.

In addition to reviewing the information described above, section 24(4) of the NSCA places the onus on the CNSC to ensure that "the applicant:

• is qualified to carry on the activity that the licence will authorize the licensee to carry on, and
• will, in carrying on that activity, make adequate provision for the protection of the environment, the health and safety of persons and the maintenance of national security and measures required to implement international obligations to which Canada has agreed."

The comprehensive assessment that takes place during the licensing process may result in defining additional programs and criteria, as a condition(s) of the licence. Once the CNSC's personnel are satisfied that all of the requirements of the NSCA and its associated regulations are met, and the applicant's documentation is complete and acceptable, a licence recommendation is prepared by the CNSC's personnel for submission to the Commission Tribunal - or a DO - for a decision. The recommended licence may include any necessary conditions that were identified as required during the assessment, including the documentation references submitted in support of the application. By referring to the applicant's documentation, the licence legally binds the applicant to comply with its own procedures and programs, and makes them subject to the CNSC's compliance, verification and enforcement program.

Licences may also contain other terms and conditions, such as references to standards, with which licensees must comply. For example, licensees may be required to observe occupational and public radiological exposure limits derived (or adopted) from internationally accepted standards, such as those of the ICRP. Limits for controlled release of gaseous or liquid effluents or solid materials are adopted from complementary regulatory regimes, such as the Provincial Water Quality Objectives or Metal Mining Limits for Liquid Effluent Releases, or derived from specific licence conditions, such as the Derived Release limits. Other standards, established by organizations like the CSA and the American Society of Mechanical Engineers (ASME), may also be adopted by the CNSC.

Joint Regulatory Review Process

Although the nuclear sector is subject to federal jurisdiction through the NSCA, the CNSC utilizes a harmonized or joint review approach with other federal, provincial or territorial departments in such areas as health, environment, transport and labour. The CNSC would expect nuclear facilities to comply with all applicable federal and provincial regulations.

In recognition of this dual reason, the CNSC has established a joint regulatory process. As a lead agency, the CNSC invites other federal and provincial regulatory agencies whose area of responsibility could impact on the proposed nuclear facility to participate in the licensing process. Those that choose to participate become members of a site-specific Joint Regulatory Group (JRG).

This procedure ensures that the legitimate concerns of both federal and provincial agencies are considered in the regulatory process and are reflected, as appropriate, in the licence in the form of site specific requirements. For example, the CNSC and the Saskatchewan departments of Environment and Labour have an administrative agreement that optimizes the participation of the Ministry of Environment (MoE) and the Ministry of Advanced Education, Employment and Labour (Labour) in the administration of the CNSC's regulatory regime. The involvement of Labour and the MoE, in the regulation of Saskatchewan's uranium mines and mills helps to better:

protect the health, safety and security of Canadians and their environment, and

harmonize the CNSC, MoE and Labour regulatory requirements and regulatory activities.

Example of a New Licence

The following is an example of a licence that the Commission Tribunal issued after the last report was published. After public hearings on June 22, 2007 and September 12, 2007, the CNSC issued a Class IB operating licence for Ontario Power Generation's Darlington Waste Management facility. This licence, issued on October 24, 2007, allows OPG to operate a spent fuel dry storage waste management facility at the Darlington Nuclear Generating Station location, on the shore of Lake Ontario and close to Toronto. The licence was issued for a five-year term and requires OPG to submit a mid-term status report on operational performance in January 2010.

Licence Periods

Typical licence terms for radioactive waste management facilities vary from five to ten years in duration.

In 2002, the CNSC introduced flexible licence terms to allow for more risk-informed regulation of spent fuel and radioactive waste management facilities. The CNSC may consider adjusting licence terms based on licensee performance, facility risks and compliance and verification findings. Short licence periods will continue to be an option when licensee performance is unsatisfactory or given other considerations. However, along with longer licence terms being assigned, the Commission Tribunal has requested mid-term or status updates, to allow the Commission Tribunal and the public to stay informed about the facilities' operations and performance. In some cases, such as Rio Algom's waste management facility operating licence, licences have been issued for indefinite terms on the condition that status reports be provided at five-year intervals.

The CNSC's personnel recommend licence periods using a set of consistent factors. These factors include: facility related hazards, the development and implementation of safety programs (see section E.5.3), the implementation of an effective monitoring and maintenance program, licensee experience and performance, Cost Recovery Fees Regulations and the facility's planning cycle.

Regardless of the specifics of the licence term, or the schedule of mid-term or status reports, the CNSC's personnel have an obligation to inform the Commission Tribunal of any significant event at a nuclear facility licensed by the CNSC. Should such an event occur, all operational issues must be included in a Significant Development Report (SDR) to be presented to the Commission Tribunal.

Licence Renewals

Applications for licence renewal or amendment require the CNSC to revisit the original documentation and assessment in light of licensee performance and compliance history (see section E.6.1). The CNSC bases its review on performance history, risk and expert judgment, and may add, modify or remove licence conditions.

Since the last report and following public hearings on April 11, 2007 and January 24, 2007, the CNSC renewed a Class IB operating licence for OPG's Western Waste Management Facility. This licence, issued on May 22, 2007, allows OPG to operate a radioactive waste management facility (including spent fuel dry storage) on the location of the Bruce Nuclear Generating Station. The licence was renewed for a 10-year term on the condition that a status report on operational performance be submitted after the third and seventh year of the licence term.

Licence Amendments

Amendments to spent fuel, radioactive waste management and uranium mine and mill licences can modify existing licence conditions, add new licensing requirements or approve revisions to the facility design, its operations or licensee programs referenced in the licence. Examples of such documents include: operating policies and principles (OP&P), station-shift complement, radiation protection requirements and emergency plans, before reaching a decision. DOs, when delegated by the Commission Tribunal, can typically amend Waste Nuclear Substance licences.

Since the last reporting period, the Commission Tribunal amended the Beaverlodge Waste Facility Operating Licence, extending the expiry date to January 25, 2007. On March 7, 2007, the Commission Tribunal also amended the radioactive waste facility operating licence for the Hydro-Québec facility located in Bécancour, Québec.

E.4.3 Information and participation of the public

Public hearings

As discussed in the CNSC Licensing Procedure (see section E.4.1), the NSCA requires that a public hearing be held before a licensing decision is made or whenever it is in the public interest to do so. Public hearing proceedings give non-nuclear organizations and interested members of the public a reasonable opportunity to comment on matters before the Commission Tribunal. The CNSC Rules of Procedure (Rules) apply to these proceedings and set out the requirements for, among others, the notification of public hearings and publication of decisions from public hearings.

In accordance with the Rules, a public hearing may take place on a single day or on two non-consecutive days. Most major decisions are made following a two-day public hearing process. Day one and two may be several months apart (the usual timeframe is 60 days), to allow stakeholders enough time to review the application and recommendations. The CNSC's licensing process is described in Annex 3.

Streamlining

Since the last reporting period, panels of the Commission Tribunal also conducted hearings to increase the efficiency of the Commission Tribunal's operations and maintain the forum's effectiveness. The the CNSC's President established several panels of one or more members last year to exercise Commission Tribunal functions. Under the NSCA, not all Commission Tribunal members must be in attendance at a Commission Tribunal activity. A smaller panel of members can exercise certain powers. The Commission Tribunal's use of panels is in line with the practices of other Canadian administrative tribunals.

Abridged hearings

The Commission Tribunal is required to make all decisions with respect to applications to amend licences previously issued by the Commission Tribunal (i.e., for Class I nuclear facilities and uranium mines and mills). Many of these applications regard minor changes and updates that are of low safety significance to a facility's operations and reference documentation. The Commission Tribunal therefore decided, in accordance with Part 2 of the Rules, that in such cases, it may be neither efficient nor in the public interest to hold full public hearings.

The Commission Tribunal must also decide on approvals and other requested changes to - or deviations from - licence requirements when the authority to make such decisions has not been previously delegated to the CNSC's personnel or the changes or deviations are akin to a licence amendment. An abridged hearing process may also be used, when appropriate, for such approvals, changes or deviations.

To consider Class I and uranium mines and mills licence amendments that pose relatively low-risk as fairly, informally and expeditiously as possible, the Commission Tribunal may, in accordance with Rule 3 of the Rules, hold hearings over an abridged timeframe and with a reduced notice period and limited opportunity, if any, for interventions. For example, the Commission Tribunal used an abridged hearing process to accept the Environmental Impact Statement for the proposed Port Hope long-term low-level radioactive waste-management project on January 24, 2007.

Outreach activities

The CNSC's personnel outreach program is described in Annex 3.11.

Public hearings and meetings are fundamental to the CNSC personnel's outreach activities. The Commission Tribunal publishes Records of Proceedings, including Reasons for Decision to explain the basis for its licensing decisions. This document, along with other information about the Commission Tribunals' proceedings and decisions, is publicly available at: nuclearsafety.gc.ca The Commission Tribunal also posts the complete transcripts of all public proceedings within days of a hearing or meeting, a best practice confirmed through benchmarking analysis.

Although most hearings are held in Ottawa, an increasing number of affected communities use videoconferencing as a cost effective way to participate. The Commission Tribunal offers teleconference and videoconference services to facilitate access to public hearings and meetings. Since the last reporting period, and as part of the CNSC's ongoing efforts to provide easier access to the Commission Tribunal's proceedings and enhance the visibility of the CNSC, the public can now view live webcasts of all public hearings and meetings through the organization's external Web site. Archived webcasts of past proceedings are also available online for three months following the proceedings. Note that in an effort to encourage public participation, the Commission Tribunal periodically holds licensing hearings relating to large, complex facilities in the local communities.

In 2005-06, the Commission Tribunal conducted 29 hearings. A total of 192 intervenors participated through written and oral submissions. In 2006-07, the Commission Tribunal conducted and documented 49 hearings, where it duly considered submissions from applicants and input from the CNSC's personnel and stakeholders. The Commission Tribunal continued to focus on outreach and community engagement during 2006-07, when it heard presentations and considered written submissions from more than 600 intervenors. In 2007-08, the Commission Tribunal conducted 43 hearings and heard 198 intervenors.

E.5 A system of prohibition of the operation of spent fuel or radioactive waste without a licence

Under section 26 of the NSCA, no person may possess, package, transport, manage, store or dispose of a nuclear substance, except in accordance with a licence issued by the CNSC or when exempted by the regulations. Since all radioactive waste contains nuclear substances, radioactive waste is subject to the NSCA and associated regulations.

E.6 System of institutional control, regulatory inspection and documenting and reporting

E.6.1 General description of compliance program

As stated in section E.4.1, only the Commission Tribunal or a Designated Officer can issue licences to operate spent fuel and waste management facilities.

Section 30 of the NSCA authorizes the CNSC's personnel who are designated inspectors to carry out inspections and verify licensee compliance with regulatory requirements, including licence conditions. Licensees must have an approved set of programs and processes in place that adequately protect the environment and human health and safety.

The CNSC's Regulatory Policy Compliance (P-211) is implemented through a corporate wide compliance program whose output is integral to the operating licence renewal process and which integrates all three compliance elements:

• Promotion to encourage compliance,
• Verification activities to confirm that licensees are complying with safety provisions, and
• Reactive control measures to enforce compliance.

The CNSC rigorously enforces its regulatory requirement through a variety of measures such as inspections, reviews, audits and assessments. The CNSC's personnel:

• apply regulatory requirements in a manner that is fair, predictable and consistent,
• use rules, sanctions, and processes that are securely founded in law and graded according to the seriousness of the violation, the compliance history of the licensee and the actions of the licensee once the violation is discovered,
• establish and maintain a compliance verification program based upon the level of risk that the radioactive material or activity presents to human health, its authorized use and the environment,
• ensure that its compliance activities are conducted by trained and qualified staff, and
• develop and implement a compliance promotion strategy and a compliance-enforcement strategy.

E.6.2 Compliance promotion

The compliance program aims to inform the regulated community of the rationale behind the regulatory regime, disseminate information to regulated areas about regulatory requirements and standards, and design realistic and achievable requirements and standards. Promotional activities include communication and consultation.

The most common communication and consultation activity used to promote compliance consists is regularly scheduled meetings with the licensee, at which ongoing activities and developments, licensing and compliance issues, safety performance, outstanding commitments and emerging issues are discussed. Generally, compliance verification activities also result in follow-up meetings. The frequency of planned meetings varies by licensee, facility and risk level.

E.6.3 Compliance verification

To verify compliance with regulatory requirements and licence conditions, the CNSC:

• evaluates a licensee's operations and activities,
• reviews, verifies and evaluates licensee supplied information,
• ensures that administrative controls are in place, and
• evaluates a licensee's remedial action and any actions taken to avoid future incidents.

Programs cited in the licence or previously assessed during the licence application review process are evaluated. The CNSC checks that a licensee's activities meet acceptance criteria derived from:

• legal requirements,
• the CNSC policies, standards, or guides that clarify how the Commission intends to apply the legal requirements,
• licensee supplied information that expressly states the licensees intentions to meet the legal requirements in performing the licensed activity, and
• the CNSC personnel's expert judgment, including knowledge of industry best practices.

The CNSC's personnel assess licensee programs and their implementation according to the following five ratings:

1. Exceeds requirements,
2. Meets requirements,
3. Below requirements,
4. Significantly below requirements, and
5. Unacceptable.

The following categories are used to summarize all assessment and inspection results, as well as group licensee programs and performance in several safety areas being evaluated for licensing purposes. A standard list of programs or topics has been developed for each type of facility, and may include:

• Organization and Management,
• Non-Radiological Health and Safety,
• Public Information Programs,
• Training and Qualification,
• Radiation Protection,
• Environmental Protection,
• Emergency Preparedness,
• Fire Protection,
• Operation and Maintenance,
• Incidents and Abnormal Events,
• Quality Management,
• Decommissioning and Financial Guarantees,
• Security, and
• International Obligations (Safeguards, etc.).

Compliance verification results are used in licence renewals and mid-term reports.

Regulatory Inspections

Type II Inspections

Type II - or routine - inspections provide an overall perspective of the status of a facility in the area examined and note any obvious deficiencies or abnormalities. These may be planned or unscheduled inspections, but are usually conducted according to written check sheets, which allow an inspector to record his or her observations and recommendations for follow-up action. Check sheets are dated, signed and kept on file.

Type I Inspections

Type I evaluations are usually done according to inspection guides prepared for that specific occasion. The results are recorded and sent to the licensee for follow-up action, as necessary, and kept on file. When planned, the inspections are coordinated with the licensee and meetings are scheduled. When unscheduled inspections arise, follow-up meetings may not always be possible due to scheduling conflicts between the licensee's contacts.

Type I audits are always pre-planned to a high degree of detail, with acceptance criteria spelled out in advance. The licensee is notified in advance of the audit and its subject area. Entrance meetings, daily briefings of audit results and exit meetings are included in audit plans. Personnel who conduct the audit are chosen for their expertise in the area being assessed. They could include specialists from head office, project officers onsite or from head office, or a combination of the two. The audit results are recorded in a CNSC report to the licensee and follow-up actions are recorded and assigned dates for completion.

Regulatory Reporting

The CNSC's personnel also assess the contents of submitted operating reports. Licensees are required to submit operating reports to the CNSC according to licence conditions. The frequency of these submissions varies by licensee, facility and risk level, but it generally ranges from quarterly to annually. The analysis of safety significant events is another component in the safety performance evaluation of a facility. The objective of these analyses is not for the CNSC personnel to duplicate reviews done by licensees, but to ensure that licensees have adequate processes in place to take corrective actions when needed and integrate lessons learned from past events into day-to-day operation.

E.6.4 Compliance enforcement

The CNSC uses a gradual approach to enforcement, commensurate with the risk or regulatory significance of the violation. The enforcement tools available to the CNSC are:

• discussion,
• verbal or written notice,
• warning,
• increased regulatory scrutiny,
• issuance of an order,
• licensing action (i.e. amendment or suspension of part of a licence),
• revocation of personal certification,
• prosecution, and
• revocation or suspension of a licence.

Depending on the effectiveness of the initial action, subsequent enforcement measures of increasing severity may be invoked.

E.7 Considerations taken into account in deciding whether or not to regulate nuclear substances as radioactive waste

Section E.3.1 indicates that the CNSC is authorized, under the NSCA, to regulate nuclear substances so as to protect human health and the environment. The CNSC Regulatory Policy P-290, Managing Radioactive Waste, defines radioactive waste as any waste containing a nuclear substance, leaving no room for regulatory doubt, and promotes the following key principles with respect to radioactive waste:

• the generation of radioactive waste should be minimized to the extent practicable, and
• radioactive waste should be managed in a manner that is commensurate with its radiological, chemical and biological hazards.

(For a full description of Regulatory Policy P-290, refer to section B.5.)

E.8 Establish regulatory body

E.8.1 Funding of the CNSC

The CNSC is a departmental corporation, listed in Schedules II and V of the Financial Administration Act. The NSCA stipulates that the CNSC report to the Parliament of Canada through a member of the Privy Council for Canada who is designated by the Governor in Council. Currently, this designate is the Minister of Natural Resources Canada. The Commission requires the involvement and support of the Minister for special initiatives such as amendments to regulations and requests for funding.

The CNSC's operations are funded through annual appropriations from Parliament. Most costs incurred for the CNSC regulatory activities are recovered through licence fees, under the CNSC Cost Recovery Fees Regulations. The CNSC collects these fees and deposits them into the Consolidated Revenue Fund of the Government of Canada. The activities that are not cost-recoverable activities, such as cost-exempt licensees and fulfillment of international obligations, are funded by the federal government.

Recently, due to growth in the nuclear sector, the CNSC has experienced rapidly increasing demand for its licensing, licensee certification and pre-project power-plant design review activities. As a result, the regulatory body has necessarily explored alternate funding mechanisms to meet future resource requirements. In 2007-08, the CNSC received approval from Canada's Treasury Board for revenue spending authority commencing in 2008-09. This authority is being phased in over a two-year period, with full implementation of revenue spending authority for all cost-recoverable activities effective in 2009-10. This authority will enable the CNSC to address growth in the nuclear sector.

E.8.2 Maintaining competent personnel

Recruitment and retention of personnel continues to be a focus for the CNSC. Since the last reporting period, the organization has increased its staff by more than 30 percent. Between April 1, 2006 and March 31, 2008 alone, the CNSC hired 178 people. Even more growth is anticipated in the coming years due to growth in the regulated industry.

In support of this growth, the CNSC reviewed its recruitment and retention strategy to ensure stated goals are achievable and current. The revised strategy emphasizes knowledge management, raising the CNSC's profile through employer branding, human resources planning, and recruitment and development of new personnel.

Given the importance of employee development, the CNSC continues to encourage learning and development opportunities for managers and employees. The implementation of mandatory individual learning plans will ensure that employees prepare for future careers with the CNSC, while building the skills required for their current roles. In addition to the more than 100 in-house courses offered each year, the CNSC encourages employees to attend external training courses. The CNSC is placing particular emphasis on developing and implementing a comprehensive leadership program.

New employees and managers at the CNSC are further supported by a recently launched Orientation program, which is comprised of a comprehensive orientation manual, a half-day orientation session and an enhanced orientation Web site (due to launch in fall 2008).

The CNSC also continues to contribute to the CANTEACH and University Network of Excellence in Nuclear Engineering (UNENE) programs. (See section F.3.2.)

Aboriginal Consultation

Consulting Canadians on matters of interest and concern to them is an important part of good governance, sound policy development and decision-making. In addition to good governance objectives Canada has statutory, contractual and common law obligations to consult with Aboriginal groups. To this end, and as one of the many departments, agencies and other Government of Canadian entities that, collectively, comprise the federal Crown, the CNSC is obligated to ensure that any regulatory activity that it undertakes that may have an impact on established or potential Aboriginal rights is informed by rigorous consultation with prospective rights holders.

The role of the CNSC in ensuring that this legal obligation is fulfilled may vary, depending on the nature of the project in question, the role of other federal entities, etc. In some instances the CNSC may be part of a federal Crown consultation team, in other instances it may be the lead or coordinator, and in yet other cases the CNSC may be the sole federal entity involved in consulting a group of Aboriginal peoples with respect to a particular project.

The role of the CNSC in ensuring that the legal duty to consult is met reflects the entire nuclear cycle and all aspects of nuclear safety in Canada. From mining and milling, to transportation of radioactive materials, the construction and operation of power reactors, and decommissioning and fuel waste management, the CNSC acknowledges that Aboriginal rights may potentially be impacted at any given stage in the cycle. The CNSC also recognizes that other federal departments, agencies, as well as provincial and territorial governments, as representatives of the Crown, have a role to play in most if not all of those stages, and thus sees itself as one of many organizations that, collectively, have an obligation to ensure that the legal duty to consult is met. For further information is available at: nuclearsafety.gc.ca/eng/resources/aboriginal-consultation/index

Management System

In 2005, the CNSC formally committed to establishing a corporate wide management system in accordance with the requirements and guidance set out in IAEA's Safety Standard Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety (GS-R-1), draft standard Management Systems for Regulatory Bodies (DS-113) and accompanying safety guides. Furthermore, the CNSC established a Quality Council. The the CNSC's Executive Vice President of Operations holds the position of Chief Quality Officer and heads the council. A new division for internal quality management was also formed.

The purpose of the management system is to define and apply a common set of practices, principles and processes across the entire organization. The management system will provide the CNSC with an overarching and uniform management structure by:

• bringing together, in a coherent and consistent manner, all of the organization's business requirements,
• mapping out and managing processes as part of a larger integrated system to minimize duplication,
• defining roles, responsibilities and authorities,
• defining processes and procedures that relate to activities, as opposed to general functional roles, and
• serving as a consistent framework for continual and ongoing improvements.

In December 2007, the CNSC issued the Management System Manual as the top-tier document which describes the integrated management system to ensure consistent quality results. Ongoing efforts are focused on process development and documentation of the lower-tiered documents, including processes, procedures, forms and guides.

Integrated Regulatory Review Services (IRRS)

the CNSC established a project to host a mission from the IAEA's Integrated Regulatory Review Services (IRRS) focused on power plants. The CNSC sent a letter officially requesting the mission to the IAEA in November 2005. The project is being planned and executed in accordance with relevant IAEA documents and will follow the IAEA's modular IRRS approach.

As part of the CNSC's preparation for the IRRS mission, a self-assessment review team (SART) conducted an assessment in 2006, which outlined recommendations for improvements at the CNSC. A corrective action plan was drafted during the reporting period to respond to the SART's suggestions and establish an integrated plan to implement the following five corporate-wide improvement projects:

1. management system,

2. integrated planning and performance management,

3. regulatory compliance processes,

4. regulatory licensing processes, and

5. leadership development.

The licensing and compliance improvement initiatives aim to develop and implement integrated solutions, which will improve the effectiveness and efficiency of the CNSC activities and decisions, and clarify the roles, responsibilities, authorities, and accountabilities.

In 2006, the Integrated Improvement Initiatives Program was initiated as a way to enhance integration among all five of the aforementioned corporate wide improvement projects. The CNSC identified the management system as the lead initiative. Efforts throughout 2007 focused on process development in the areas of planning, licensing and compliance.

In 2007, following a review of IRRS missions in other countries, the CNSC chose to broaden the scope of the IRRS mission to include power plants, research reactors and other nuclear facilities and the regulation of nuclear substances. The IRRS mission is planned for May 2009.

E.9 Supporting the separation of roles

E.9.1 Separation of the CNSC and organizations that promote and utilize nuclear energy

The NSCA is distinct and comprehensive legislation for the regulation of nuclear activities and the separation of functions of the regulatory body from organizations that promote or use nuclear energy. The CNSC's mandate (see section E.3.1) focuses clearly on the health and safety of persons and the protection of the environment, and does not extend to economic matters.

Section 19 of the NSCA authorizes "the Governor in Council [to], by order, issue to the Commission directives of general application on broad policy matters with respect to the objects of the Commission." However, any political directives given to agencies - such as the CNSC - must be of a general nature and cannot fetter the Commission Tribunal's decision-making authority in specific cases. In addition, all directives must be published in the Canada Gazette and put before each House of Parliament.

E.9.2 Strategic communications

Part of the CNSC's mandate is to disseminate information to all stakeholders. The CNSC has had ongoing, transparent discussions with the Canadian Nuclear Association (via a Regulatory Affairs Committee) since 2000 and with NPPs and other licensees (via the Cost Recovery Advisory Group (CRAG)) since 2002. The CNSC's strategic communications plan was finalized during the reporting period.

The CNSC's strategic communications plan involves a three-year phased approach. During 2006 and 2007, the CNSC focused its outreach activities on heightening public awareness and understanding about regulated nuclear activities and regulatory body's role. In 2006, the CNSC made a special effort to engage diverse stakeholders, including municipal governments in the regions of major facilities, media, provincial officials, professional associations and non-governmental organizations (NGOs).

In late 2006, the CNSC established a Non-Governmental Organization Regulatory Affairs Committee to communicate and consult with NGOs on nuclear regulatory and policy matters. Co-chaired by a member of the NGO community, the Non-Governmental Organization Regulatory Affairs Committee is a forum for exchanging and clarifying information to promote common understanding of issues. It allows the CNSC to better respond to the information needs of the NGO community, while enabling NGO members to comment and advise the CNSC on broader issues related to nuclear regulation in Canada.

While a similar industry-based forum has existed since 2001, this Committee enables the CNSC to further expand its engagement with stakeholders. In addition to this forum, the CNSC also established links with an association of host communities of major nuclear facilities in early 2007.

The CNSC has held numerous hearings in host communities. To ensure the needs of future stakeholders are met, the CNSC is committed to proactively contacting communities likely to become involved in nuclear activities (such as mining and milling) in the next decade.

E.9.3 Values and ethics

The CNSC has a firmly entrenched values and ethics regime, which serves to strengthen and support value based governance, leadership and operational and individual ethical practice. Introduced in 2005, the Values and Ethics Strategy defines the organizational values on which the CNSC ethical practices are based. It includes provisions for the disclosure of wrongdoing in the workplace and the protection of employees from reprisal. To this already robust regime, the CNSC has now added the disclosure, reprisal protection and accountability elements of the Public Servants Disclosure Protection Act, which came into force in April 2007.

In 2008-09, the CNSC will receive the results of an evaluation of its Values and Ethics program and implement an Informal Conflict Management System (ICMS) within the organization. The evaluation recommendations will allow the CNSC to improve the efficacy of the Values and Ethics program, and the ICMS will provide personnel with many new dispute resolution options.

The evolution of the ethics regime at the CNSC creates an environment that supports exemplary practice and is resistant to forces and pressures that encourage inappropriate business conduct.

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