Packaging and Transport of Nuclear Substances Regulations, 2015

Packaging and Transport of Nuclear Substances Regulations, 2015 The Canadian Nuclear Safety Commission, pursuant to subsection 44(1)a of the Nuclear Safety and Control Actb, makes the annexed Packaging and Transport of Nuclear Substances Regulations, 2015. S.C. 2012, c. 19, s. 129(1) S.C. 1997, c. 9 Ottawa, April 10, 2015 His Excellency the Governor General in Council, on the recommendation of the Minister of Natural Resources, pursuant to subsection 44(1)a of the Nuclear Safety and Control Actb, approves the annexed Packaging and Transport of Nuclear Substances Regulations, 2015, made by the Canadian Nuclear Safety Commission. Definitions The following definitions apply in these Regulations. A1 has the same meaning as in the IAEA Regulations. (A1) A2 has the same meaning as in the IAEA Regulations. (A2) Act means the Nuclear Safety and Control Act. (Loi) activity means the number of nuclear transformations occurring per unit of time, as measured in becquerels. (activité) alternative activity limit for an exempt consignment, in respect of an instrument or article, means an activity limit for a consignment that is above the activity limit for an exempt consignment set out in the IAEA Regulations and that has been approved as meeting the exemption criteria set out in those Regulations for an instrument or article. (autre limite d’activité pour un envoi exempté) basic radionuclide value means either an A1 in TBq, an A2 in TBq, an activity concentration limit for an exempt material in Bq/g or an activity limit for an exempt consignment in Bq, as set out in the IAEA Regulations. (valeur de base pour un radionucléide) carrier has the same meaning as in section 1.4 of the Transportation of Dangerous Goods Regulations. (transporteur) certificate means a document issued by the Commission under paragraph 21(1)(h) of the Act or by a designated officer authorized under paragraph 37(2)(a) of the Act, indicating the certification of a package design; a design for special form radioactive material; a design for low dispersible radioactive material; the calculation of a value demonstrating that fissile-excepted radioactive material will remain subcritical; the calculation of the basic radionuclide value for radioactive material that has a basic radionuclide value that is not listed in the IAEA Regulations; or the calculation, for an instrument or article that has an alternative activity limit for an exempt consignment, of the alternative activity limit. (document d’homologation) confinement system means the assembly of fissile material and packaging components intended to preserve criticality safety. (système d’isolement) consignee has the same meaning as in the IAEA Regulations. (destinataire) consignment has the same meaning as in the IAEA Regulations. (envoi) consignor has the same meaning as in section 1.4 of the Transportation of Dangerous Goods Regulations. (expéditeur) containment system has the same meaning as in the IAEA Regulations. (enveloppe de confinement) contamination has the same meaning as in the IAEA Regulations. (contamination) conveyance has the same meaning as in the IAEA Regulations. (moyen de transport) criticality safety index has the same meaning as in the IAEA Regulations. (indice de sûreté-criticité) effective dose has the same meaning as in subsection 1(1) of the Radiation Protection Regulations. (dose efficace) excepted package means a package that is designed in accordance with the applicable requirements of the IAEA Regulations. (colis excepté) exclusive use has the same meaning as in the IAEA Regulations. (utilisation exclusive) fissile-excepted radioactive material means fissile radioactive material that is excepted from being classified as fissile in accordance with the IAEA Regulations; or contained in a package that is excepted from being classified as fissile in accordance with those Regulations. (matière radioactive fissile exceptée) fissile material has the same meaning as in the IAEA Regulations. (matière fissile) freight container has the same meaning as in the International Maritime Dangerous Goods Code. (conteneur) IAEA means the International Atomic Energy Agency. (AIEA) IAEA Regulations means the Regulations for the Safe Transport of Radioactive Material, published by the IAEA, as amended from time to time. (Règlement de l’AIEA) instrument or article means any tool, implement or object, or its components, that encloses nuclear substances and that is fabricated for a particular use other than solely for enclosing those nuclear substances. (Appareils ou objets) International Maritime Dangerous Goods Code means the document of that name published by the International Maritime Organization, as amended from time to time. (Code maritime international des marchandises dangereuses) large object means an object that has been decommissioned from a nuclear facility, that is internally contaminated with nuclear substances meeting the requirements applicable to an SCO-I or SCO-II as set out in the IAEA Regulations and that cannot be transported in a type of package described in these Regulations due to its dimensions. (objet de grande dimension) low dispersible radioactive material has the same meaning as in the IAEA Regulations. (matière radioactive faiblement dispersable) low toxicity alpha emitters has the same meaning as in the IAEA Regulations. (émetteurs alpha de faible toxicité) LSA material has the meaning assigned by the definition low specific activity (LSA) material in the IAEA Regulations. (matière LSA) management system has the same meaning as in the IAEA Regulations. (système de gestion) overpack has the same meaning as in the IAEA Regulations. (suremballage) package means packaging with its radioactive contents, as presented for transport. (colis) packaging has the same meaning as in the IAEA Regulations. (emballage) passenger has the same meaning as in section 1.4 of the Transportation of Dangerous Goods Regulations. (passager) prescribed equipment means equipment that is prescribed by paragraph 20(a) of the General Nuclear Safety and Control Regulations. (équipement réglementé) radioactive material means a nuclear substance that is a radioactive material, as defined in the IAEA Regulations. (matière radioactive) registered user means a person who has received confirmation under subsection 19(3) from the Commission that their use of a package has been registered. (usager inscrit) SCO has the meaning assigned by the definition surface contaminated object (SCO) in the IAEA Regulations. (SCO) special form radioactive material has the same meaning as in the IAEA Regulations. (matière radioactive sous forme spéciale) specific activity has the same meaning as in the IAEA Regulations. (activité spécifique) Technical Instructions for the Safe Transport of Dangerous Goods by Air means the document of that name, designated as Doc 9284, published by the International Civil Aviation Organization, as amended from time to time. (Instructions techniques pour la sécurité du transport aérien des marchandises dangereuses) transit means the process of being transported through Canada after being imported into and before being exported from Canada, in a situation where the place of initial loading and the final destination are outside Canada. (transit) transport index has the same meaning as in the IAEA Regulations. (indice de transport) Type A, in respect of a package, means that the package is designed in accordance with the applicable requirements of the IAEA Regulations. (type A) Type B, in respect of a package, means that the package is classified as either a Type B(U) or a Type B(M) package in accordance with the IAEA Regulations and is designed in accordance with the applicable requirements of those Regulations. (type B) Type C, in respect of a package, means that the package is designed in accordance with the applicable requirements of the IAEA Regulations. (type C) Type H(M), in respect of a package, means that the package has a type code of H(M) in accordance with the IAEA Regulations and is an excepted package, Type IP-1 package, Type IP-2 package, Type IP-3 package or Type A package that is designed to contain more than 0.1 kg of uranium hexafluoride that is non-fissile material or is fissile-excepted radioactive material. (type H(M)) Type H(U), in respect of a package, means that the package has a type code of H(U) in accordance with the IAEA Regulations and is an excepted package, Type IP-1 package, Type IP-2 package, Type IP-3 package or Type A package that is designed to contain more than 0.1 kg of uranium hexafluoride that is non-fissile material or is fissile-excepted radioactive material. (type H(U)) Type IP-1, in respect of a package, means that the package is designed in accordance with the applicable requirements of the IAEA Regulations. (type IP-1) Type IP-2, in respect of a package, means that the package is designed in accordance with the applicable requirements of the IAEA Regulations. (type IP-2) Type IP-3, in respect of a package, means that the package is designed in accordance with the applicable requirements of the IAEA Regulations. (type IP-3) Incorporation by reference of IAEA Regulations For the purposes of these Regulations, the incorporation by reference of any particular amendment of the IAEA Regulations is effective two years after the day on which the amendment is initially published by the IAEA or six months after the day on which the amendment is available in both of the official languages of Canada, whichever is later. Notice of effective date The Commission must note the effective date of the incorporation by reference on its website. References in French version In the French version of these Regulations, other than in paragraphs 6(1)(f), 7(h) and 11(3)(f) and subparagraph 26(1)(b)(iv), “approbation” is to be read to include “certificat d’agrément” and “certificat d’approbation” as used in the IAEA Regulations; and “approuvé” is to be read to include “agréé” as used in the IAEA Regulations. References in English version In the English version of these Regulations, other than in paragraphs 6(1)(f), 7(h) and 11(3)(f) and subparagraph 26(1)(b)(iv), “approval” is to be read to include “certificate of approval” as used in the IAEA Regulations. Application Subject to subsection (2), these Regulations apply to the packaging and transport of prescribed equipment; and nuclear substances, including the design, production, use, inspection, maintenance and repair of packaging and packages for nuclear substances, and the preparation, consigning, handling, loading, carriage, storage during transport, receipt at final destination and unloading of packages and unpacking of their contents. Exception These Regulations, except for sections 6 and 7, do not apply to the packaging and transport of a nuclear substance that is naturally occurring, provided that it has a specific activity that is less than or equal to 70 kBq/kg, or an activity concentration that does not exceed 10 times the activity concentration limit for exempt material values set out in the IAEA Regulations; that was implanted in or administered to a person or an animal for medical diagnosis or treatment purposes, or that subsists in their remains; that is contained in a sample of material taken for bioassay purposes; that is used by a holder of a licence on private property for the purpose of an activity described in paragraphs 26(a) to (c) of the Act that the licence authorizes the holder to carry on, if access to the property is controlled; that is contained in human or animal tissue samples or animal remains, or a liquid scintillation medium, if the specific activity of the nuclear substance averaged over the mass of the material does not exceed 10-6 A2/kg; that is contained in a product for which no licence is required under sections 6 to 8 of the Nuclear Substances and Radiation Devices Regulations following the sale of the product to an end user; that is an integral part of a conveyance and is required for transport purposes; that has an activity concentration that does not exceed the values for an exempt material set out in the IAEA Regulations or in a certificate for a basic radionuclide value that is not listed in the IAEA Regulations; that is in a consignment that has a total activity that does not exceed the values for an activity limit for an exempt consignment set out in the IAEA Regulations, in a certificate for a basic radionuclide value that is not listed in the IAEA Regulations or in a certificate for an instrument or article that has an alternative activity limit for an exempt consignment; that is contained in a check source for which no licence is required under section 8.1 of the Nuclear Substances and Radiation Devices Regulations following the sale of the check source to an end user; that is contained in a radiation device for which no licence is required under paragraph 5(1)(c) of the Nuclear Substances and Radiation Devices Regulations following the sale of the device to an end user; that consists of non-radioactive solid objects with radioactive material present on any surface in quantities not exceeding 0.4 Bq/cm2 for beta and gamma emitters and low toxicity alpha emitters and 0.04 Bq/cm2 for all other alpha emitters; that is in or on a person who is transported for medical treatment because the person has been subject to an accidental or deliberate intake or contamination; that is present in a load of waste that is in transport, is not classified as radioactive material and has triggered a radiation monitor alarm if the nuclear substance in the load has been determined only to be one or more of the following medical isotopes and if there is no loss or dispersal of the material during the transport: Chromium 51, Indium 111, Iodine 123, 124 or 131, Gallium 67, Technetium 99m, Thallium 201; that is being transported to a location for proper characterization in accordance with section 3, if it is present in a load that was already in transport, it is not classified as radioactive material, it has triggered a radiation monitor alarm and the maximum dose rate on any external surface of the vehicle that is transporting it is less than or equal to 500 µSv/h, and there is no loss or dispersal of the material during the transport; or that is being transported by a peace officer to a location for proper characterization, if it is a forensic sample, the peace officer has reason to believe that it is radioactive material, the maximum dose rate on contact is less than or equal to 2 mSv/h on any external surface of the container, there is no loss or dispersal of the material during the transport, and the Commission is advised immediately of the transport. Characterization The nuclear substance referred to in paragraph 2(2)(o) must be characterized at the earliest possible time to determine the extent to which it is subject to these Regulations and the Nuclear Substances and Radiation Devices Regulations. Licensable quantity For the purpose of this section, a licensable quantity of a nuclear substance is a quantity in respect of which the activity exceeds the exemption quantity, as defined in section 1 of the Nuclear Substances and Radiation Devices Regulations; or in respect of which there is no exemption from licensing under sections 5 to 8.1 of those Regulations. Documentation of characterization The person who performs the characterization must keep a record documenting the detection of the radiation and the disposal of the nuclear substance for two years; file an annual report with the Commission by April 30 that contains a summary of radiation detections for the calendar year before the date of the report; and immediately notify the Commission if the source of the radioactivity in the load is determined to be a licensable quantity of a nuclear substance. Dose rate greater than 5 µSv/h and less than or equal to 25 µSv/h If the measured dose rate at the time that the alarm is triggered is greater than 5 µSv/h and less than or equal to 25 µSv/h and there is no loss or dispersal of the nuclear substance during the transport, the consignor, the carrier and the consignee must immediately make a preliminary report to the Commission indicating the alarm level, the details of the transport, information on the location and circumstances of the detected radiation and any action that they have taken or propose to take in respect of it; and characterize the source of the radiation within 10 days after its detection and make a follow-up report immediately, if the characterization of the source of the radioactivity in the load indicates that it is a licensable quantity of a nuclear substance, or within 21 days after the initial detection, if the nuclear substance in the load is determined not to be of a licensable quantity, with a summary of the radiation detection and the disposal of the substance and a confirmation that it is not of a licensable quantity. Dose rate greater than 25 µSv/h and less than or equal to 500 µSv/h If the measured dose rate at the time that the alarm is triggered is greater than 25 µSv/h but less than or equal to 500 µSv/h and there is no loss or dispersal of the nuclear substance during the transport, the consignor, carrier and consignee must immediately make a preliminary report to the Commission indicating the alarm level, the details of the transport, information on the location and circumstances of the detected radiation and any action that they have taken or propose to take in respect of it; isolate the load, prevent dispersal of the nuclear substance and control access to it to ensure that persons are not exposed to effective doses that exceed the limits set out in section 13 of the Radiation Protection Regulations; have an expert in radiation protection assess the situation; and report the results of the assessment to the Commission within 10 days after the detection and make a follow-up report General classification Subject to section 5, packages and radioactive material must be classified in accordance with the IAEA Regulations. LSA-I material LSA material is classified as LSA-I material if it is either non-fissile material or fissile-excepted radioactive material and if it consists of ores that contain naturally occurring radionuclides with a uranium and thorium concentration not greater than 3% by mass; radioactive material for which the A2 value is unlimited, except for ores that contain naturally occurring radionuclides with a uranium and thorium concentration greater than 3% by mass; concentrates of unirradiated thorium, of natural uranium or of depleted uranium, as those terms are defined in the IAEA Regulations, or their unirradiated compounds or mixtures in solid or liquid form; any mill tailings, contaminated earth, concrete, rubble, other debris and activated materials in which the radioactive material is essentially uniformly distributed and for which the average specific activity does not exceed 10-6 A2/g; or other radioactive material in which the activity is distributed throughout and for which the estimated average specific activity does not exceed 30 times the activity concentration limit for exempt material values set out in the IAEA Regulations or in a certificate for a basic radionuclide value that is not listed in those Regulations. LSA-II material LSA material is classified as LSA-II material if it consists of material that is less than 225 L of water with a tritium concentration that has an activity level not greater than 0.8 TBq/L; or in which the activity is distributed throughout and for which the estimated average specific activity does not exceed 10-4 A2/g for solids and gases and 10-5 A2/g for liquids. LSA-III material LSA material is classified as LSA-III material if it consists of solid material that is not in powder form and that meets the applicable requirements of the IAEA Regulations. Licensing requirements A person may transport a nuclear substance without a licence issued under subsection 24(2) of the Act for that purpose, except in the following cases: the nuclear substance is a Category I nuclear material, Category II nuclear material or Category III nuclear material, as those terms are defined in section 1 of the Nuclear Security Regulations, and is transported outside the area in which it is required, under any of sections 19 to 21 of those Regulations, to be produced, processed, used or stored; the nuclear substance is in transit in a package of a certified design or in a package that has been approved as Type B(U)-96, Type C-96 or Type H(U)-96 by a foreign competent authority in accordance with the IAEA Regulations unless, in the case of transport by aircraft or ship, there is no scheduled stop in Canada; the nuclear substance is contained in a large object; the transport of the nuclear substance cannot meet the requirements of these Regulations; the transport of the nuclear substance requires a special use vessel; or the transport of the nuclear substance requires multilateral approval of shipments in accordance with the IAEA Regulations. Activity exemptions A person may possess, transfer, import, export or use prescribed equipment without a licence issued under subsection 24(2) of the Act for that purpose. Packaging exemptions A person may package a nuclear substance without a licence issued under subsection 24(2) of the Act for that purpose. Prohibitions imposed by section 26 of Act For greater certainty, the exemptions established in subsections (1) to (3) relate only to the packaging and transport of nuclear substances and do not otherwise derogate from the prohibitions imposed by section 26 of the Act. Application for licence An application for a licence under subsection 24(2) of the Act to transport a nuclear substance must contain the applicable information required by section 3 of the General Nuclear Safety and Control Regulations; the information required by section 100 of the Nuclear Security Regulations if the substance is a Category I nuclear material, Category II nuclear material or Category III nuclear material, as those terms are defined in section 1 of those Regulations; the name, postal address and telephone number of each consignor and consignee; if the nuclear substance is one of those referred to in paragraph 6(1)(b), a description of the nuclear substance, including the name, chemical form and physical state, the activity — or, in the case of fissile material, the mass — of each nuclear substance in a package and the total activity or mass in the consignment, the country of origin of the nuclear substance, the reason for selecting a route through Canada, the name of each carrier, the dates, times and locations of its arrival into and departure from Canada and of any scheduled stop or transshipment in Canada, the number of the certificate or approval applicable to the package, the number of packages to be transported, the types of conveyance to be used during transit, if a vessel is to be used as a conveyance during transit, the name of the vessel and its flag state, the United Nations number for the nuclear substance, and the reference number of the emergency response assistance plan that is approved under section 7 of the Transportation of Dangerous Goods Act, 1992 or a reference to the effect that a plan is not required, as the case may be; if the nuclear substance is contained in a large object, information that demonstrates that the internal contamination is contained within the object and that all openings are sealed, meets the requirements applicable to an SCO-I or SCO-II as set out in the IAEA Regulations, is caused by a substance that is classified as non-fissile or fissile-excepted radioactive material, and is caused by a substance that is in solid form and that any liquid content is negligible, information that demonstrates that the large object meets the free drop test requirements set out in the IAEA Regulations for the industrial package type referred to in section 27 for the SCO classification determined for the internal contamination, does not have a dose rate on contact of more than 2 mSv/h from the accessible surfaces of the object, as prepared for shipment, and does not have more than 4 Bq/cm2 of contamination on the exterior surfaces, a detailed transport plan covering all activities associated with the shipment, including radiation protection, emergency response, and any special precautions or special administrative or operational controls that are to be employed during transport, and details of the applicable management system; if the transport of the nuclear substance cannot meet the requirements of these Regulations, information that demonstrates that the overall level of safety in transport is at least equivalent to that which would be provided if all the applicable requirements of these Regulations were met, a statement of the reasons why the consignment cannot meet the requirements of these Regulations, and a statement of any special precautions or special administrative or operational controls that are to be employed during transport to compensate for the inability to meet the requirements of these Regulations; if the transport of the nuclear substance requires a special use vessel, the vessel owner’s and operator’s contact information, including, as applicable, their names, postal addresses, email addresses, telephone numbers and fax numbers, a copy of the radiation protection program applicable to the shipment, details of the consignment, information on the stowage arrangements for the duration of the voyage, including for any consignments loaded or unloaded at ports of call en route, the dates, times and locations of arrival into and departure from Canada and of any scheduled stop in Canada, a copy of any certificate or approval applicable to packages or materials in the consignment, the name of the vessel and its flag state, and a copy of any document issued by the competent authority of the vessel’s flag state approving the radiation protection program; and if the transport of the nuclear substance requires approval of shipment in accordance with the IAEA Regulations, the period of time, related to the shipment, for which the approval is sought, information on the radioactive contents, the expected types of conveyance and the probable or proposed route, details of how the precautions and administrative or operational controls referred to in the approval for the package design, if applicable, that was issued in accordance with the IAEA Regulations are to be put into effect, a copy of the applicable approvals for the package design, and in the case of fissile material, information on the sum of criticality safety indexes and any related safety assessment, emergency response plan and administrative or operational controls. Type H(M) packages Type H(M) packages must meet the following requirements: they must be designed and maintained to meet national or international standards other than the International Organization for Standardization standard ISO 7195 entitled Nuclear Energy — Packaging of uranium hexafluoride (UF6) for transport, as amended from time to time, provided that an equivalent level of safety is maintained; they must withstand, without leakage and without unacceptable stress, a hydraulic test at an internal pressure of at least 1.38 MPa; they must withstand, without loss or dispersal of uranium hexafluoride, the free drop test set out in the IAEA Regulations for normal conditions of transport; they must withstand, without rupture of the containment system, the thermal test set out in the IAEA Regulations for accident conditions of transport, unless they are designed to contain 9 000 kg or more of uranium hexafluoride; and they must not be equipped with pressure relief devices. Type H(U) packages Type H(U) packages must meet the following requirements: they must be designed and maintained to meet the International Organization for Standardization standard ISO 7195 entitled Nuclear Energy — Packaging of uranium hexafluoride (UF6) for transport, as amended from time to time; they must withstand, without leakage and without unacceptable stress, as specified in standard ISO 7195, as amended from time to time, the hydraulic test set out in the IAEA Regulations; they must withstand, without rupture of the containment system, the thermal test set out in the IAEA Regulations for accident conditions of transport; and Requirement to certify design of prescribed equipment The design of the following types of prescribed equipment must be certified by the Commission or a designated officer before the design is used: Type B and Type C packages; packages used to transport fissile material; packages used to transport 0.1 kg or more of uranium hexafluoride; special form radioactive material; and low dispersible radioactive material. Approval by foreign competent authority The design of the following types of prescribed equipment may be used without being certified if, before the design is used, it is approved by a foreign competent authority in accordance with the IAEA Regulations: special form radioactive material, if it is being transported; a Type B(U)-96 or Type C-96 package, if it is in transit; and a Type H(U)-96 package, if it contains 0.1 kg or more of uranium hexafluoride. Certification of subcriticality of fissile-excepted radioactive material The calculation of a value demonstrating that fissile-excepted radioactive material will remain subcritical must be certified by the Commission or a designated officer before the value is used, except in relation to the following materials: uranium enriched in uranium-235 to a maximum of 1% by mass and with a plutonium and uranium-233 content not exceeding 1% of the mass of uranium-235, provided that the fissile nuclides are distributed essentially homogeneously throughout the material and any uranium-235 that is present in metallic, oxide or carbide forms must not form a lattice arrangement; liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2% by mass, with a plutonium and uranium-233 content not exceeding 0.002% of the mass of uranium, and with a minimum nitrogen to uranium (N/U) atomic ratio of 2; uranium with a maximum uranium enrichment of 5% by mass of uranium-235 provided that there is no more than 3.5 g of uranium-235 per package, the plutonium and uranium-233 content does not exceed 1% of the mass of uranium-235 per package, and the amount of fissile nuclides in the consignment is limited to 45 g; fissile nuclides with a total mass not greater than 2.0 g per package, provided that the total mass of fissile nuclides in the consignment is limited to 15 g; and fissile nuclides with a total mass not greater than 45 g per consignment, either packaged or unpackaged, provided that it is transported under exclusive use. Certification of calculation of values The following calculations must be certified by the Commission or a designated officer before the value is used: the calculation of the basic radionuclide value for radioactive material that has a basic radionuclide value that is not listed in the IAEA Regulations; and the calculation of the alternative activity limit for an instrument or article that has an alternative activity limit for an exempt consignment. Application for certification of design An application for certification of a design for the types of prescribed equipment referred to in subsection 10(1) must include the information required for the applicable approval under the IAEA Regulations and the number of any applicable approval issued by a foreign competent authority, in accordance with the IAEA Regulations; in respect of a package design, the recommended inspection and servicing program, and instructions for packing, transport, receiving, maintenance and unpacking; and any other information necessary to demonstrate that the design meets the requirements of these Regulations. Observing of test An applicant must give the Commission, or a designated officer, a reasonable opportunity to observe any test that the applicant intends to conduct to demonstrate the compliance of a design with these Regulations, including reasonable notice of the date and time of the test. New application for certification No later than 60 days after the day on which the certificate of a design expires, an applicant may make a new application to the Commission or a designated officer to certify the design if the technical specifications of the design have not been modified. The application must include a statement confirming that the drawings and procedures previously submitted have not been modified or, if they have been modified, a copy of the revised drawings and procedures and a statement confirming that the modifications are without technical significance and do not affect the safety of the design; a statement confirming that each type of prescribed equipment referred to in subsection 10(1) has been produced and maintained in compliance with the drawings and procedures previously submitted; a statement confirming that the instructions previously submitted in respect of the certified design have not been modified; unless previously submitted, the model number and drawings of any capsule containing radioactive material; a list of the serial numbers used for the certified design, other than a certified design referred to in paragraph (f); in respect of a design that was certified after approval by a foreign competent authority in accordance with the IAEA Regulations, a list of the serial numbers currently in use or intended for use in Canada; a list of the known users in Canada of the latest certified design; a summary of the maintenance performed and any operational or maintenance problems encountered with the certified design, including the date, the nature of the problem and any action taken; a copy of any applicable approval issued by the foreign competent authority in accordance with the IAEA Regulations since the last certification; a copy of the documents submitted to the foreign competent authority to obtain each approval; and any other information necessary to demonstrate that the design meets the applicable requirements of these Regulations. Application for certification of subcriticality An application for certification of the calculation referred to in subsection 10(3) must include a description of the fissile-excepted radioactive material, including its name, chemical form and physical state; the calculation of a value demonstrating that the material will remain subcritical without the need for accumulation control under the conditions described in the IAEA Regulations, including tests performed, principles used, assumptions made, scenarios considered, limitations that should be applied and any data, formulae or analysis tool used; in respect of the calculation, a copy of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations; in respect of a special form radioactive material, a copy of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations or a copy of any applicable certificate; in respect of low dispersible radioactive material, a copy of any applicable certificate; details of any actions needed to be taken before shipment; and any other information necessary to demonstrate that the calculation meets the applicable requirements of these Regulations. No later than 60 days after the day on which the certificate expires, an applicant may make a new application for certification to the Commission or a designated officer if the calculation of the value has not been modified. The application must include a statement confirming that the calculation of a value demonstrating that the material will remain subcritical without the need for accumulation control under the conditions described in the IAEA Regulations has not been modified and that the tests performed, principles used, assumptions made, scenarios considered, limitations that should be applied and any data, formulae or analysis tool used have not been modified; a statement confirming that the details of the applicable management system and any actions needed to be taken before shipment that were previously submitted have not been modified; and Application for certification of calculated values An application for certification of the calculation referred to in subsection 10(4) must include a description of the nuclear substance, including its name, chemical form and physical state; the calculation of the basic radionuclide value, including the principles used, assumptions made, scenarios considered and any data or formulae used to determine the value; a copy of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations; in respect of an instrument or article, details of the instrument or article that will contain the nuclear substance, including the identification, details of construction and intended uses of the instrument or article and the location of the nuclear substance, the maximum activity of the instrument or article, the maximum external radiation level arising from the instrument or article, details of the management system for the design and production of the instrument or article, and instructions for the use, inspection, maintenance and disposal of the instrument or article; and No later than 60 days after the day on which the certificate expires, an applicant may make a new application for certification to the Commission or a designated officer if the calculation has not been modified. The application must include a statement confirming that the calculation of the basic radionuclide value, including the principles used, assumptions made, scenarios considered and any data or formulae used to determine the calculation, has not been modified; in respect of an instrument or article, a statement confirming that the information previously submitted has not been modified or, if it has been modified, the revised information and a statement confirming that the modifications are without technical significance and do not affect safety; a statement confirming that the instructions previously submitted in respect of the certified calculation have not been modified; and Application for certification The applications for certification referred to in sections 11 to 13 must be made to the Commission or a designated officer. Modifications requiring new certification If the certified design or calculation referred to in section 10 has been modified in a manner that affects the safety of the prescribed equipment referred to in that section, the certificate is void and a new application for certification must be made. Notice of refusal to certify The Commission, or the designated officer, must notify a person who has applied for certification of a proposed decision not to certify, as well as the basis for the proposed decision, at least 30 days before making the decision. Right to be heard The notice must include a description of the person’s right to be provided with an opportunity to be heard in accordance with section 17. Notice of decertification The Commission, or the designated officer, must notify a person to whom a certificate has been issued and, in the case of a certificate for a package design, any registered user of a package of that design, of a proposed decision to decertify, as well as the basis for the proposed decision, at least 30 days before making the decision. The notice must include a description of the person’s and the registered user’s right to be provided with an opportunity to be heard in accordance with section 17. Opportunity to be heard The Commission, or the designated officer, must provide the person referred to in section 15 or 16 or the registered user referred to in section 16 with an opportunity, in respect of the proposed decision, to be heard either orally or in writing if, within 30 days after the date of the notice, they request that opportunity. Notification of final decision Every person and registered user who is notified in accordance with section 15 or 16 must be notified of the final decision and the reasons for it. Producing package of certified design Every person who produces a package of a certified design must produce the package in accordance with the requirements set out in the certificate; and clearly mark the package with the certificate number, design number and serial number. Application for registration A person who intends to use a package of a certified design must apply to the Commission to register their use of the package. Information for registration The Commission must register the applicant’s intended use of the package on receipt of an application containing the following: the applicant’s contact information, including, as applicable, their name, postal address, email address, telephone number and fax number; the name of a person who can be contacted for transport purposes; the number of any licence that the applicant holds in respect of the contents of the package; the number of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations; the package’s design and serial numbers; and a statement confirming that the applicant possesses the instructions necessary to prepare the package for shipment, as set out in the certificate for the package design. Confirmation An applicant may use the package only if they have received confirmation from the Commission that their use of the package has been registered. Producing special form radioactive material Every person who produces special form radioactive material must use a certified design and produce the material in accordance with the requirements set out in the certificate; and clearly mark the material, or any source holder to which it is permanently attached, in a unique, legible and durable manner. Transporting special form radioactive material A person may transport special form radioactive material only if it has been produced in accordance with a certified design or a design approved by a foreign competent authority in accordance with the IAEA Regulations. Prior approvals Every person who possesses special form radioactive material, the design of which was approved under the 1973, 1973 (as amended), 1985 or 1985 (as amended in 1990) edition of the IAEA Regulations, must ensure that the material was produced before January 1, 2004 and that it is used in compliance with section 24. Producing low dispersible radioactive material Every person who produces low dispersible radioactive material must clearly mark the material in a unique, legible and durable manner. Transporting low dispersible radioactive material A person may transport low dispersible radioactive material only if it has been produced in accordance with a certified design. Instrument or article having alternative activity limit Every person who produces an instrument or article that has an alternative activity limit for an exempt consignment must use the applicable certified calculation and produce the instrument or article in accordance with the requirements set out in the certificate. Transporting instrument or article having alternative activity limit A person may transport an instrument or article that has an alternative activity limit for an exempt consignment only if it has been produced using the applicable certified calculation. Producing fissile-excepted radioactive material Every person who produces fissile-excepted radioactive material that requires a certified calculation of a value demonstrating that the material will remain subcritical must do so in accordance with the requirements set out in the certificate. Transporting fissile-excepted radioactive material A person may transport fissile-excepted radioactive material that requires a certified calculation of a value demonstrating that the material will remain subcritical only if it has been produced in accordance with the requirements set out in the certificate. Management system Every person who designs, produces, tests, uses, inspects, maintains or repairs prescribed equipment must implement and maintain a management system in accordance with the IAEA Regulations; keep a record documenting the system and of any information collected under it; and retain the record for a period ending two years after the day on which the prescribed equipment is removed from service. General obligations Every person who transports, or presents for transport, radioactive material must comply with the requirements of the Transportation of Dangerous Goods Regulations. Consignor’s responsibilities Every consignor, other than a consignor of an excepted package, must comply with the requirements of the IAEA Regulations in respect of the provision of information for carriers; the notification of competent authorities; and the possession of certificates and instructions. Advising consignee The consignor must advise the consignee that the material is going to be transported. Carrier’s responsibilities Every carrier of radioactive material must comply, in respect of transport and storage, with the requirements of the IAEA Regulations except in respect of placarding; transport the material in accordance with the consignor’s instructions; and implement and maintain work procedures to ensure compliance with these Regulations and keep a record documenting those procedures. Packages for transport A consignor may present for transport and a carrier may transport radioactive material if the material is contained in an excepted package, a Type IP-1, Type IP-2 or Type IP-3 package, a Type A package, a Type B or Type C package of a certified design, a package of a certified design used to transport fissile material, or a package of a certified design used to transport 0.1 kg or more of uranium hexafluoride; the following if a licence has been issued for that purpose under subsection 24(2) of the Act: a nuclear substance contained in a large object, a nuclear substance whose transport does not meet all of the requirements of these Regulations, a nuclear substance whose transport requires a special use vessel, a nuclear substance whose transport requires multilateral approval of shipments in accordance with the IAEA Regulations, and a package that is in transit and is of a design that has been approved as a Type B(U)-96 or Type C-96 package by a foreign competent authority in accordance with the IAEA Regulations; unpackaged LSA-I material or an unpackaged SCO-I, in accordance with the IAEA Regulations; and a package that contains 0.1 kg or more of uranium hexafluoride and that is of a design that has been approved as a Type H(U)-96 package by a foreign competent authority in accordance with the IAEA Regulations. Activity or mass limits The activity or mass of the radioactive material contained in the package must be within the applicable limit for that type of package as set out in the IAEA Regulations; in any applicable certificate; and in any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations. Previously not requiring certification Despite subsection (1), a package that does not require certification by the Commission and whose design meets the requirements of the 1985 or 1985 (as amended in 1990) edition of the IAEA Regulations may be used if the package meets the applicable requirements of section 25; and the packaging was neither manufactured nor modified after December 31, 2003.

Previously certified Despite subsection (1), a package manufactured to a package design certified under the requirements of the 1973, 1973 (as amended), 1985 or 1985 (as amended in 1990) edition of the IAEA Regulations may continue to be used if the package meets the applicable requirements of section 25; its manufacture began before January 1, 1996, for designs that meet the requirements of the 1973 or 1973 (as amended) edition of the IAEA Regulations, or January 1, 2007, for designs that meet the requirements of the 1985 or 1985 (as amended in 1990) edition of the IAEA Regulations; or it contains fissile material that meets the applicable requirements for fissile material of the editions of the IAEA Regulations issued after 2009. Requirements For packages prepared in accordance with the requirements of an edition of the IAEA Regulations before the 2012 edition, if the material was considered fissile-excepted radioactive material under that earlier edition, and if it is neither excluded from the definition of fissile material nor excepted from the provisions applicable to fissile material in the editions of those Regulations issued after 2009, the package may be transported, provided that it is under exclusive use and the following formula yields a result of less than one: is the mass in grams of uranium-235; is 400 if the fissile material is mixed with substances that have an average hydrogen density less than or equal to water, or 290 in all other cases; is the mass in grams of all other fissile nuclides, as defined in the IAEA Regulations; and is 250 if the fissile material is mixed with substances that have an average hydrogen density less than or equal to water, or 180 in all other cases. Transport requirements for LSA and SCO Subject to subsections (2) and (3), both LSA material and an SCO must be transported in Type IP-3 packages. No escape of radioactive contents LSA-I material and an SCO-I may be transported unpackaged in accordance with the IAEA Regulations, but must be transported in a manner that ensures that, under routine conditions of transport, there will be no escape of the radioactive contents from the conveyance or any loss of shielding. Transport in accordance with IAEA Regulations LSA material and an SCO may be transported in Type IP-1 packages and Type IP-2 packages in accordance with the IAEA Regulations if the LSA material and the SCO are transported in conveyances that are not carrying passengers; are transported in conveyances or freight containers from one consignor only; and are only loaded at the consignor’s location and unloaded at the consignee’s location. Responsibilities of consignors and carriers under IAEA Regulations Consignors and carriers of radioactive material must comply with the IAEA Regulations in respect of requirements to be met before the first shipment and before each shipment; requirements for the transport of other goods; requirements and controls for contamination and for leaking packages; requirements and controls for transport of excepted packages; the determination of the transport index; the determination of the criticality safety index; the limits on the transport index, criticality safety index and radiation levels; the determination of categories for packages, overpacks and freight containers; and the marking and labelling of packages, overpacks and freight containers, except that the figures illustrating labels found in the IAEA Regulations must be replaced by the corresponding illustrations for Class 7 radioactive materials that are set out in the Appendix to Part 4 of the Transportation of Dangerous Goods Regulations. Exceptions Despite subsection (1), a consignor may present for transport and a carrier may transport, by road, radioactive material in a package, or a package within an overpack, that is not labelled in accordance with the IAEA Regulations, if the package or overpack contains or is an exposure device of a model that is certified, and the package or overpack is transported with goods from one consignor only and in a conveyance that is not carrying passengers, the package or overpack is transported in a conveyance that displays on each side and on each end a placard for Class 7 radioactive materials as set out in the Appendix to Part 4 of the Transportation of Dangerous Goods Regulations, and both the package and the overpack, if one is used, are clearly marked with the word “RADIOACTIVE” or “RADIOACTIF”; the package is an excepted package; or the package or overpack contains only LSA-I material other than uranium hexafluoride and the package or overpack is only loaded at the consignor’s location and unloaded at the consignee’s location, the package or overpack is transported by road in a conveyance or freight container that displays on each side and on each end a placard for Class 7 radioactive materials as set out in the Appendix to Part 4 of the Transportation of Dangerous Goods Regulations, and both the package and the overpack, if one is used, are clearly marked with the words “RADIOACTIVE LSA-I” or “LSA-I RADIOACTIF”. Definition For the purpose of subsection (2), certified and exposure device have the same meaning as in section 1 of the Nuclear Substances and Radiation Devices Regulations. Despite subsection (1), a consignor may present for transport and a carrier may transport radioactive material in accordance with the International Maritime Dangerous Goods Code or the Technical Instructions for the Safe Transport of Dangerous Goods by Air. English or French may be used If the English and French versions of the IAEA Regulations each prescribe the use of a word, the word prescribed by either version may be used. Particulars of consignment Every consignor of radioactive material must include in the transport documents for the consignment the particulars of consignment that are required by the IAEA Regulations, which particulars must be clearly and indelibly printed. Subsection (1) does not apply to an excepted package if the transport documents contain the following information: the identification of the consignor and consignee, the United Nations number assigned to the material as set out in the IAEA Regulations, preceded by the letters “UN”, the proper shipping name as set out in the IAEA Regulations, the identification mark for the certification described in each of sections 12 to 14, as applicable, and the identification mark of any applicable special form radioactive material approval issued by a foreign competent authority in accordance with the IAEA Regulations; or to a consignor who provides transport documents that have been prepared in accordance with the International Maritime Dangerous Goods Code or the Technical Instructions for the Safe Transport of Dangerous Goods by Air. Obligation Every carrier who transports a consignment of radioactive material must ensure that it is accompanied by the transport documents referred to in subsection (1) or (2). Exception for exposure devices The transport documents in respect of radioactive material that is in an exposure device, referred to in paragraph 28(2)(a), transported in accordance with that paragraph do not need to meet the requirements set out in the IAEA Regulations for the category of the package and transport index. For the purposes of sections 31 and 33, committed, equivalent dose and radon progeny have the same meaning as in subsection 1(1) of the Radiation Protection Regulations. Radiation protection program Every consignor, carrier or consignee of radioactive material, other than one who only handles or transports excepted packages, must implement a radiation protection program and must, as part of that program, keep the amount of exposure to radon progeny and the effective dose and equivalent dose received by and committed to persons as low as reasonably achievable, taking into account social and economic factors, through the implementation of management control over work practices, personnel qualification and training, control of exposure to radiation by personnel and the public, and planning for unusual situations; prevent persons from receiving doses of radiation higher than the radiation dose limits prescribed by the Radiation Protection Regulations; assess the radiation at the workplace and conduct workplace or individual monitoring if it may reasonably be expected that the doses of radiation received by persons at the workplace will be 1 mSv or more but less than 5 mSv a year, or conduct individual monitoring if it may reasonably be expected that the doses of radiation received by persons at the workplace will be 5 mSv a year or more; and train the persons referred to in the program on the application of the program. Requirement to keep records Every consignor, carrier or consignee must keep a record documenting their radiation protection program and of any information collected under it; and retain the record for a period ending two years after the day on which the information is collected. When dose limit exceeded Every consignor, carrier or consignee who becomes aware that a dose of radiation received by a person may have exceeded an applicable dose limit prescribed by the Radiation Protection Regulations must immediately notify the person and the Commission of the dose; conduct an investigation to determine the magnitude of the dose and to establish the causes of the exposure; take any action required to prevent the occurrence of a similar incident; and within 21 days after becoming aware that the dose limit may have been exceeded, report to the Commission the results of the investigation or the progress that has been made in conducting it. Provision of information Every consignor, carrier or consignee must inform every nuclear energy worker that they employ, in writing, of the fact that the worker is a nuclear energy worker; of the risks associated with the radiation to which the worker may be exposed in the course of their work, including the risks associated with the exposure of embryos and foetuses to radiation; of the applicable effective dose limits and equivalent dose limits prescribed by sections 13 and 14, respectively, of the Radiation Protection Regulations; and of the worker’s radiation dose levels. Obligation to inform In the case of a female nuclear energy worker, the consignor, carrier or consignee must inform her, in writing, that she is required, as soon as she is aware that she is pregnant, to inform her employer of that fact in writing; inform her, in writing, of the applicable effective dose limits prescribed by the Radiation Protection Regulations; and on being informed of the pregnancy, make any accommodation that will not result in costs or business inconvenience constituting undue hardship to it to comply with the effective dose limits prescribed by section 13 of the Radiation Protection Regulations. Acknowledgement of information Every consignor, carrier or consignee must obtain from each nuclear energy worker that they employ who is informed of the matters referred to in paragraphs (1)(a) and (b) and subsection (2) a written acknowledgement that the worker has received the information. Collection of personal information If a consignor, carrier or consignee collects personal information, as defined in section 3 of the Privacy Act, that may be required to be disclosed to the Commission, another government institution, as defined in that section, or a dosimetry service, the consignor, carrier or consignee must inform the person to whom the information relates of the purpose for which it is being collected. Required information Every nuclear energy worker whose work requires that they engage in activities that are subject to these Regulations must provide the following information to their employer: their given names, surname and any previous surname; their Social Insurance Number; their gender; their date, province and country of birth; and their dose record, as applicable, for the current one-year dosimetry period and five-year dosimetry period as those terms are defined in subsection 1(1) of the Radiation Protection Regulations. Interpretation For the purpose of sections 36 to 38, a dangerous occurrence is any of the following situations: a conveyance carrying radioactive material is involved in an accident; a package shows evidence of damage, tampering or leakage of its contents, or its integrity is degraded in a manner that may reasonably be expected to impair its ability to comply with these Regulations or its certificate; radioactive material is lost, stolen or no longer in the control of a person who is required to have control of it under the Act; radioactive material has escaped from a containment system, a package or a conveyance during transport; fissile material is outside the confinement system during transport; the level of non-fixed contamination, as defined in the IAEA Regulations, during transport exceeds the following limits as applicable when averaged over any area of 300 cm2 of any part of the surface of the package or the conveyance: 4 Bq/cm2 for beta and gamma emitters and low toxicity alpha emitters, or 0.4 Bq/cm2 for all other alpha emitters; there is a failure to comply with the provisions of the Act, the provisions of these Regulations or any licence or certificate that is applicable to a package that may reasonably be expected to lead to a situation in which the environment, the health and safety of persons or national security is adversely affected. Obligations in event of dangerous occurrence The consignor, carrier or consignee of a package or radioactive material involved in a dangerous occurrence or any other person who controls any area affected by a dangerous occurrence must immediately limit, to the extent possible, the dispersal of any radioactive material; place barriers, signs or personnel at every point of entry into the affected area to control the entry of persons into that area; and record the name, postal address and telephone number of any person who may have been exposed to or contaminated by radioactive material and request that the person remain available for assessment by an expert in radiation protection. Expert assessment As soon as feasible after a dangerous occurrence has occurred the consignor, carrier or consignee of the package or radioactive material involved in the occurrence must have an expert in radiation protection assess the situation. The expert must report the results of the assessment to the Commission as soon as feasible. Preliminary report Immediately after becoming aware of a failure to comply with the requirements of section 26 or after the obligations set out in subsection 36(1) have been discharged, every consignor, carrier, consignee and holder of a licence to transport a package while in transit must make a preliminary report of the situation to the Commission. No preliminary report is required for the dangerous occurrence referred to in paragraph 35(f) in respect of the internal surfaces of a tank or intermediate bulk container, as those terms are defined in the IAEA Regulations — or of a freight container or conveyance — that is dedicated to the transport of unpackaged radioactive material under exclusive use for as long as it remains under that specific exclusive use. Informing consignor Every carrier, consignee and holder of a licence referred to in subsection (1) must immediately notify the consignor if that person is not already aware of the failure to comply or of the dangerous occurrence. Contents of preliminary report All preliminary reports must include information on the location and circumstances of the failure to comply or of the dangerous occurrence and on any action that the consignor carrier, consignee or holder of a licence referred to in subsection (1) has taken or proposes to take with respect to it. Full report Within 21 days after the failure to comply with the requirements of section 26 or after the dangerous occurrence, the consignor, carrier and consignee and any holder of a licence to transport a package while in transit must file a full report with the Commission that includes the following information: the date, time and location of the failure to comply or of the dangerous occurrence; the names of the persons involved; the details of the packaging and packages; the probable cause; the effects on the environment, the health and safety of persons, and national or international security that have resulted or may result; the doses of radiation that any person has received or is likely to have received; and the actions taken to remedy the failure to comply or the dangerous occurrence and to prevent its recurrence. Release under Transportation of Dangerous Goods Act, 1992 For the purpose of the definition release in section 2 of the Transportation of Dangerous Goods Act, 1992, the following levels of ionizing radiation are established: in respect of a package that is being transported under exclusive use, 10 mSv/h on the external surface of the package, 2 mSv/h on the surface of the conveyance, and 0.1 mSv/h at a distance of 2 m from the surface of the conveyance; and in respect of a package that is not being transported under exclusive use, 2 mSv/h on the external surface of the package, 0.1 mSv/h at a distance of 1 m from the package, 0.1 mSv/h at a distance of 2 m from the surface of the conveyance. Opening of packages A person, other than the consignor or the consignee of the package, may open a package only if measures are taken to prevent persons from receiving doses of radiation higher than the radiation dose limits prescribed by the Radiation Protection Regulations; and the package is opened in the presence of an expert in radiation protection. Restoring opened package If a person other than the consignor or the consignee opens a package while in transport, the person must restore the package to a condition that meets the requirements of these Regulations before forwarding it to the consignee. Responsibilities on opening package Every person who receives a package or who opens a package must, at that time, determine if any of the following conditions exist: the package is damaged; the package has been tampered with; if the package contains fissile material, whether any portion of the fissile material is outside the confinement system; and any portion of the contents of the package is outside the containment system. If any of the conditions exist, the person must immediately make a preliminary report to the Commission and to the consignor. The preliminary report must include information on how and where the condition was discovered and on any action that the person has taken or proposes to take with respect to it. Within 21 days after the condition has been discovered the consignor and the person who made the preliminary report must file a full report with the Commission that includes the following information: the date, time and location of the discovery of the condition; the actions taken to remedy the condition and to prevent its recurrence. Undeliverable consignments If a consignment cannot be delivered to the consignee, the carrier must notify the consignor, the consignee and the Commission; and keep the consignment in an area to which access is controlled by the carrier until it can be delivered to the consignor or the consignee. Records to be kept and retained Every person who packs radioactive material in a Type IP-2, Type IP-3 or Type A package must keep a record documenting the following information concerning the package: the technical specifications of its design; the type, quantity and physical state of the radioactive material that it is designed to contain; any document that demonstrates that the package meets the requirements of these Regulations and the management system; and instructions for packing, transport, receiving, maintenance and unpacking. Period of retention Every person who is required to keep a record must retain it for a period ending two years after the day on which the packing occurs. [Amendments] [Amendment] [Repeal] Registration or approval These Regulations come into force on the day on which they are registered, but if they are approved by the Governor in Council after that day, they come into force on the day on which they are approved. [Note: Regulations in force June 12, 2015.]