GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Class II Nuclear Facilities and Prescribed Equipment Regulations — 4
4 An application for a licence to operate a Class II nuclear facility shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations : (a) the name and location of the nuclear facility; (b) the proposed commissioning plan; (c) a description of the results of any commissioning work; (d) evidence that the applicant is the owner of the site or has authority from the owner of the site to operate the nuclear facility; (e) a description of the components, systems and equipment proposed to be used, including their design operating conditions; (f) the proposed measures, policies, methods and procedures for operating and maintaining the nuclear facility; (g) a description of the proposed procedures for handling, storing, loading and transporting nuclear substances and hazardous substances; (h) the proposed quality assurance program; (i) the type and energy of radiation produced by any particle accelerator to be encompassed by the licence; (j) the proposed measures to ensure that the type of beam producible by, and the maximum output energy, limits to the beam orientation and maximum radiation dose rate of, the Class II prescribed equipment cannot be inadvertently altered; (k) the proposed method for measuring the effectiveness of the shielding of the nuclear facility and any results of those measurements; (l) a description of the proposed portable radiation detection equipment, including its type, sensitivity, range and accuracy and the methods and procedures for calibrating it; (m) the proposed methods, procedures and equipment for conducting the leak tests required by these Regulations; (n) a description of any proposed area radiation monitoring system; (o) the anticipated maximum dose of radiation that may be received by any person as a result of the commissioning of the nuclear facility; (p) the expected and maximum radiological workloads, per week in grays at 1 m, for any teletherapy machine to be encompassed by the licence; (q) the anticipated number of hours per week that the Class II prescribed equipment in the nuclear facility will be operated for the purpose of treatment, dosimetry, servicing or research; (r) the proposed methods, procedures and equipment for conducting radiation surveys, including the frequency of the surveys and the location of radiation survey points; (s) the proposed responsibilities of and qualification requirements and training program for workers; and (t) the proposed plan for the decommissioning of the nuclear facility.
Class II Nuclear Facilities and Prescribed Equipment Regulations — 5
5 An application for a licence to decommission a Class II nuclear facility shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations : (a) the name and location of the nuclear facility; (b) the proposed nature of and schedule for the decommissioning; (c) the land, buildings, structures, components, systems, equipment, nuclear substances and hazardous substances that will be affected by the decommissioning; (d) the nature, quantity and activity of any radioactive nuclear substances at the nuclear facility; (e) the nature and extent of any radioactive contamination at the nuclear facility, including radiation dose rates; (f) the proposed measures to control releases of radioactive nuclear substances and hazardous substances into the environment; (g) the anticipated maximum dose of radiation that may be received by any person as a result of the decommissioning; (h) the maximum quantities and concentrations of nuclear substances and hazardous substances that may be released into the environment; (i) the effects on the environment and the health and safety of persons that may result from the decommissioning, and the measures that will be taken to prevent or mitigate those effects; (j) the proposed responsibilities of and qualification requirements for workers; and (k) a description of the planned state of the site upon completion of the decommissioning.
Class II Nuclear Facilities and Prescribed Equipment Regulations — 6
6 An application for a licence in respect of Class II prescribed equipment, other than a licence to service, shall contain a copy of or the number of any certificate relating to the equipment in addition to the information required by section 3 and, where applicable, section 4 of the General Nuclear Safety and Control Regulations .
Class II Nuclear Facilities and Prescribed Equipment Regulations — 7
7 An application for a licence to service Class II prescribed equipment shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations : (a) the name, model number and characteristics of the equipment or the number of the certificate relating to the equipment; (b) a description of the nature of the servicing proposed to be carried on; (c) the proposed methods, procedures and equipment for carrying on the servicing; (d) the proposed qualification requirements and training program for workers; and (e) the proposed procedures to be followed after completion of the servicing to confirm that the equipment is safe to use.
Class II Nuclear Facilities and Prescribed Equipment Regulations — 8
8 A person may carry on any of the following activities without a licence: (a) prepare a site for a Class II nuclear facility; (b) construct, operate, modify, decommission or abandon a Class II nuclear facility that includes a geophysical logging particle accelerator; or (c) decommission a Class II nuclear facility that includes a brachytherapy remote afterloader. SOR/2008-119, s. 7
Class II Nuclear Facilities and Prescribed Equipment Regulations — 9
9 A person may, without a licence to carry on an activity in relation to Class II prescribed equipment, possess, transfer or produce Class II prescribed equipment that does not contain a nuclear substance. SOR/2008-119, s. 7
Class II Nuclear Facilities and Prescribed Equipment Regulations — 10
10 No person shall use Class II prescribed equipment unless (a) it is a certified model; or (b) it is used in accordance with a licence that authorizes its use for development purposes or for scientific research that is not conducted on humans. SOR/2008-119, s. 8
Class II Nuclear Facilities and Prescribed Equipment Regulations — 11
11 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act may certify a model of Class II prescribed equipment after receiving an application that includes the following information: (a) the applicant's name and business address; (b) the name and business address of the manufacturer of the equipment; (c) the brand name and model number of the equipment; (d) the design of the equipment and its components, including any standards used in the design; (e) the intended use of the equipment; (f) the name, quantity in becquerels and form of the nuclear substance to be incorporated into the equipment; (g) the method of incorporating the nuclear substance into the equipment; (h) the expected radiation dose rates around the equipment in all modes of operation, including the method, calculations and measurements used to establish them; (i) the maximum radiation dose rate that the equipment can deliver; (j) instructions for the use, transportation and storage of the equipment; (k) instructions for conducting leak tests on the equipment; (l) instructions for dealing with accidents involving the equipment; (m) a description of the labelling of the equipment; (n) the quality assurance program that was followed during the design of the equipment and that will be followed during the production of the equipment; (o) the type of package for and the procedures for packaging and transporting any equipment that may contain a nuclear substance, including the emergency response plan to be followed in case of a transportation accident involving the equipment; (p) the recommended inspection and servicing program for the equipment; (q) the type of beam producible by, and the maximum output energy and limits to the beam orientation of, any particle accelerator or radioactive source teletherapy machine; (r) the estimated maximum photon and neutron leakage during the use of any teletherapy machine; and (s) the half-lives of activated components of any particle accelerator and the radiation dose rate at 30 cm from those components. (t) [Repealed, SOR/2008-119, s. 9] (2) The Commission or the designated officer may request any other information that is necessary to enable the Commission or the designated officer to determine whether the equipment model in question poses an unreasonable risk to the environment, the health and safety of persons or national security and whether certification of the equipment model would be in conformity with measures of control and international obligations to which Canada has agreed. SOR/2008-119, s. 9
Class II Nuclear Facilities and Prescribed Equipment Regulations — 12
12 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person who has applied for the certification of a model of Class II prescribed equipment of a proposed decision not to certify the model, as well as the basis for the proposed decision, at least 30 days before refusing to certify it. (2) The notice shall include a description of the person's right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 14.
Class II Nuclear Facilities and Prescribed Equipment Regulations — 13
13 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person to whom a certificate for a model of Class II prescribed equipment has been issued, and any licensee who is licensed in respect of that model, of a proposed decision to decertify the model, as well as the basis for the proposed decision, at least 30 days before decertifying it. (2) The notice shall include a description of the person's and the licensee's right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 14.
Class II Nuclear Facilities and Prescribed Equipment Regulations — 14
14 (1) Where a person referred to in section 12 or 13 or a licensee referred to in section 13 has received a notice and has requested, within 30 days after the date of receipt of the notice, an opportunity to be heard either orally or in writing, the person or the licensee shall be provided with such an opportunity in accordance with the request. (2) On completion of a hearing held in accordance with subsection (1), every person and licensee who was notified in accordance with section 12 or 13 shall be notified of the decision and the reasons for it. (3) Where neither a person referred to in section 12 or 13 nor a licensee referred to in section 13 requests an opportunity to be heard within the period referred to in subsection (1), they shall be notified of the decision and the reasons for it.
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15
ipment shall be equipped with a key switch or code-operated device that prevents persons who are not authorized by the licensee from operating the equipment. (13) After a device or system referred to in subsection (2), (3), (5), (6), (7) or (8) is serviced, the licensee shall not use the Class II prescribed equipment until the licensee performs a test or an inspection that establishes that the device is functioning as prescribed by those subsections. (14) Subsections (2), (3) and (7) and paragraphs (9)(b) and (c) do not apply in respect of a particle accelerator that meets at least one of the following criteria: (a) its radiation dose rate at 30 cm is not greater than 200 µSv per hour when it is being operated in the manner that produces the maximum dose rate as limited either by its characteristics or by its interlocks, and it is located in a room that is equipped with a lock and that can be unlocked and entered only by persons who have been authorized by the licensee; or (b) its radiation dose rate at 30 cm is not greater than 25 µSv per hour when it is being operated in the manner that produces the maximum dose rate as limited either by its characteristics or by its interlocks. (15) Paragraphs (2)(b), (3)(b) and (9)(b) do not apply in respect of a brachytherapy remote afterloader that contains a total quantity of nuclear substance that, if exposed, would produce a radiation dose rate in air of less than 10 mGy per hour at a distance of 1 m. SOR/2008-119, s. 10; SOR/2010-108, s. 1(F)
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.01
15.01 (1) Every licensee who operates a Class II nuclear facility shall appoint a radiation safety officer. (2) Every licensee who services Class II prescribed equipment shall appoint a radiation safety officer. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.02
15.02 No person shall hold the position of radiation safety officer unless the person has been certified by the Commission or a designated officer authorized under paragraph 37(2)(b) of the Act. SOR/2010-107, s. 2 SOR/2022-15, s. 1(E)
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.03
15.03 An application by a licensee for certification of a person as a radiation safety officer shall include the following information: (a) the name of the person; (b) a record of that person’s education, training and experience; (c) a statement by the licensee that, in their opinion, the person is capable of performing the duties of the position; and (d) the Class II prescribed equipment in respect of which the person may be certified. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.04
15.04 (1) The Commission, or a designated officer authorized under paragraph 37(2)(b) of the Act, shall certify a person for the position of radiation safety officer if (a) the person has successfully completed a certification examination that is recognized by the Commission; (b) in the opinion of the Commission, or of the designated officer, the person is capable of performing the duties of the position; and (c) in the opinion of the Commission, or of the designated officer, certification is consistent with the purpose of the Act. (2) A certificate issued under subsection (1) shall specify the Class II prescribed equipment in respect of which it is valid. SOR/2010-107, s. 2 SOR/2022-15, s. 2(E) SOR/2025-197, s. 1
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.05
15.05 A certificate comes into effect on the day on which it is issued and is valid for the period in which the person is employed by the licensee as a radiation safety officer. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.06
15.06 (1) A person who is employed as a radiation safety officer on the day on which these Regulations come into force is deemed to have been certified in accordance with section 15.04. (2) A licensee shall notify the Commission of the name of the radiation safety officer and the Class II prescribed equipment in respect of which the deemed certification is valid within 30 days after the day on which these Regulations come into force. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.07
15.07 (1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act shall notify a licensee who has applied for the certification of a person, and the person in respect of whom certification is being sought, of a proposed decision not to certify the person and the basis for that proposed decision at least 30 days before refusing to certify the person. (2) The notice shall include a description of the licensee’s and the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.09. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.08
15.08 (0.1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act may decertify a person if the conditions set out in subsection 15.04(1) are no longer met. (1) The Commission or a designated officer authorized under paragraph 37(2)(b) of the Act shall notify a person in respect of whom a certificate has been issued, and the licensee concerned, of a proposed decision to decertify the person and the basis for that proposed decision at least 30 days before decertifying the person. (2) The notice shall include a description of the licensee’s and the person’s right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 15.09. SOR/2010-107, s. 2 SOR/2025-197, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.09
15.09 (1) If a licensee or a person referred to in section 15.07 or 15.08 has received a notice and has requested, within 30 days after the date of receipt of the notice, an opportunity to be heard orally or in writing, the licensee or the person shall be provided with an opportunity to be heard in accordance with the request. (2) On completion of a hearing held in accordance with subsection (1), the licensee or the person shall be notified of the decision and the reasons for it. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.1
15.1 Every licensee shall designate in writing a person qualified to replace the certified radiation safety officer during the radiation safety officer’s absence. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.11
15.11 A person designated under section 15.1 may replace the certified radiation safety officer for not more than 60 working days in any consecutive 365-day period. SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 15.12
15.12 The requirement in section 15.01 does not apply in respect of a Class II nuclear facility for which a person who has duties equivalent to those of a radiation safety officer is designated and who is certified under subsection 9(2) of the Class I Nuclear Facilities Regulations . SOR/2010-107, s. 2
Class II Nuclear Facilities and Prescribed Equipment Regulations — 16
16 (1) Every person who enters a room in which an irradiator that uses more than 10 15 Bq of a nuclear substance is located shall, on entering the room, ascertain that the radiation field in the room is safe by using a radiation survey meter. (2) A person referred to in subsection (1) shall, immediately before entering the room, verify that the radiation survey meter is in working order. SOR/2008-119, s. 12
Class II Nuclear Facilities and Prescribed Equipment Regulations — 16.1
16.1 (1) Every licensee who uses a brachytherapy remote afterloader shall ensure that patients who have received treatments by means of that equipment are surveyed by a radiation survey meter and are free of nuclear substances from the remote afterloader immediately following each treatment. (2) Every licensee shall ensure that when the brachytherapy remote afterloader is being used, the treatment room is equipped with the following: (a) a remote alarm system to detect and warn of any interruption in treatment if the control panel area is not continuously occupied by staff during treatment; (b) a shielded storage container of sufficient size to hold the radioactive sources in an emergency; and (c) the remote handling tools necessary to recover the radioactive sources in an emergency. SOR/2008-119, s. 13
Class II Nuclear Facilities and Prescribed Equipment Regulations — 17
17 (1) Every licensee who installs a sealed source in any Class II prescribed equipment other than a pool-type irradiator shall, after installing the source, take measurements of radiation dose rates when the equipment is not in the irradiation mode and notify the Commission in writing as soon as practicable if the dose rate at any location that is 1 m from any sealed source in its shielded position exceeds the manufacturer’s specifications. (2) Every licensee who possesses a radioactive source teletherapy machine shall, after the installation of a sealed source in the machine, take measurements of radiation dose rates at all accessible locations outside the room in which the machine is located, with the machine in the irradiation mode and operating under conditions that will result in the maximum dose rate at each location. SOR/2008-119, s. 13
Class II Nuclear Facilities and Prescribed Equipment Regulations — 18
18 (1) Every licensee who uses, decommissions or services Class II prescribed equipment shall make available to each worker a radiation survey meter that (a) has been calibrated within the 12 months preceding its use; (b) is capable of measuring the gamma, X-ray and, if applicable, neutron radiation from the sealed source and the Class II prescribed equipment; and (c) indicates whether the power level of its batteries is sufficient for its operation. (2) No person shall use, for the purposes of the Act, the regulations made under the Act or an order or a licence, a radiation survey meter that has not been calibrated within the 12 months preceding its use. SOR/2008-119, s. 14
Class II Nuclear Facilities and Prescribed Equipment Regulations — 19
19 (1) Every licensee who possesses or uses, in or for Class II prescribed equipment, either a sealed source containing 50 MBq or more of a nuclear substance or a nuclear substance as shielding shall, at the following times, conduct leak tests on the sealed source or shielding using instruments and procedures that enable the licensee to detect a leakage of 200 Bq or less of the nuclear substance: (a) if the sealed source or shielding is used after being stored for 12 or more consecutive months, immediately before using it; (b) if the sealed source or shielding is being stored, every 24 months; (c) if an event that may have damaged the sealed source or shielding has occurred, immediately after the event; and (d) in all other cases, (i) if the sealed source or shielding is located inside Class II prescribed equipment, every 12 months, and (ii) if the sealed source or shielding is not located inside Class II prescribed equipment, every six months. (2) Where a licensee, in the course of conducting a leak test on a sealed source or on shielding, detects the leakage of 200 Bq or more of a nuclear substance, the licensee shall (a) discontinue using the sealed source or shielding; (b) discontinue using the Class II prescribed equipment in which the sealed source or shielding is located or may have been located; (c) take measures to limit the spread of radioactive contamination from the sealed source or shielding; and (d) immediately after complying with paragraphs (a) to (c), notify the Commission that the leakage has been detected. (3) Subsection (1) does not apply in respect of a sealed source that is used or stored underwater in a Class II nuclear facility that consists of a pool-type irradiator equipped with a device capable of detecting water-borne contamination of 200 Bq or less of a nuclear substance. SOR/2008-119, s. 15
Class II Nuclear Facilities and Prescribed Equipment Regulations — 20
20 No licensee shall use Class II prescribed equipment on a person except as directed by a medical practitioner who is qualified to give such direction under the applicable provincial legislation.