Packaging and Transport of Nuclear Substances Regulations, 2015 (SOR/2015-145)
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Regulations are current to 2024-08-18
Certification
Marginal note:Requirement to certify design of prescribed equipment
10 (1) The design of the following types of prescribed equipment must be certified by the Commission or a designated officer before the design is used:
(a) Type B and Type C packages;
(b) packages used to transport fissile material;
(c) packages used to transport 0.1 kg or more of uranium hexafluoride;
(d) special form radioactive material; and
(e) low dispersible radioactive material.
Marginal note:Approval by foreign competent authority
(2) 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:
(a) special form radioactive material, if it is being transported;
(b) a Type B(U)-96 or Type C-96 package, if it is in transit; and
(c) a Type H(U)-96 package, if it contains 0.1 kg or more of uranium hexafluoride.
Marginal note:Certification of subcriticality of fissile-excepted radioactive material
(3) 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:
(a) 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;
(b) 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;
(c) uranium with a maximum uranium enrichment of 5% by mass of uranium-235 provided that
(i) there is no more than 3.5 g of uranium-235 per package,
(ii) the plutonium and uranium-233 content does not exceed 1% of the mass of uranium-235 per package, and
(iii) the amount of fissile nuclides in the consignment is limited to 45 g;
(d) 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
(e) 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.
Marginal note:Certification of calculation of values
(4) The following calculations must be certified by the Commission or a designated officer before the value is used:
(a) 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
(b) the calculation of the alternative activity limit for an instrument or article that has an alternative activity limit for an exempt consignment.
Marginal note:Application for certification of design
11 (1) 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
(a) the number of any applicable approval issued by a foreign competent authority, in accordance with the IAEA Regulations;
(b) in respect of a package design,
(i) the recommended inspection and servicing program, and
(ii) instructions for packing, transport, receiving, maintenance and unpacking; and
(c) any other information necessary to demonstrate that the design meets the requirements of these Regulations.
Marginal note:Observing of test
(2) 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.
Marginal note:New application for certification
(3) 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) 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;
(b) 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;
(c) a statement confirming that the instructions previously submitted in respect of the certified design have not been modified;
(d) unless previously submitted, the model number and drawings of any capsule containing radioactive material;
(e) a list of the serial numbers used for the certified design, other than a certified design referred to in paragraph (f);
(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;
(g) a list of the known users in Canada of the latest certified design;
(h) 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;
(i) a copy of any applicable approval issued by the foreign competent authority in accordance with the IAEA Regulations since the last certification;
(j) a copy of the documents submitted to the foreign competent authority to obtain each approval; and
(k) any other information necessary to demonstrate that the design meets the applicable requirements of these Regulations.
Marginal note:Application for certification of subcriticality
12 (1) An application for certification of the calculation referred to in subsection 10(3) must include
(a) a description of the fissile-excepted radioactive material, including its name, chemical form and physical state;
(b) 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;
(c) in respect of the calculation, a copy of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations;
(d) 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;
(e) in respect of low dispersible radioactive material, a copy of any applicable certificate;
(f) details of the applicable management system;
(g) details of any actions needed to be taken before shipment; and
(h) any other information necessary to demonstrate that the calculation meets the applicable requirements of these Regulations.
Marginal note:New application for certification
(2) 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) 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;
(b) a copy of any applicable approval issued by the foreign competent authority in accordance with the IAEA Regulations since the last certification;
(c) 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
(d) any other information necessary to demonstrate that the calculation meets the applicable requirements of these Regulations.
Marginal note:Application for certification of calculated values
13 (1) An application for certification of the calculation referred to in subsection 10(4) must include
(a) a description of the nuclear substance, including its name, chemical form and physical state;
(b) 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;
(c) a copy of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations;
(d) in respect of an instrument or article,
(i) 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,
(ii) the maximum activity of the instrument or article,
(iii) the maximum external radiation level arising from the instrument or article,
(iv) details of the management system for the design and production of the instrument or article, and
(v) instructions for the use, inspection, maintenance and disposal of the instrument or article; and
(e) any other information necessary to demonstrate that the calculation meets the applicable requirements of these Regulations.
Marginal note:New application for certification
(2) 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) 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;
(b) 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;
(c) a copy of any applicable approval issued by the foreign competent authority in accordance with the IAEA Regulations since the last certification;
(d) a statement confirming that the instructions previously submitted in respect of the certified calculation have not been modified; and
(e) any other information necessary to demonstrate that the calculation meets the applicable requirements of these Regulations.
Marginal note:Application for certification
14 (1) The applications for certification referred to in sections 11 to 13 must be made to the Commission or a designated officer.
Marginal note:Modifications requiring new certification
(2) 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.
Marginal note:Notice of refusal to certify
15 (1) 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.
Marginal note:Right to be heard
(2) 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.
Marginal note:Notice of decertification
16 (1) 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.
Marginal note:Right to be heard
(2) 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.
Marginal note:Opportunity to be heard
17 (1) 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.
Marginal note:Notification of final decision
(2) 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.
Production, Use and Possession of Prescribed Equipment
Marginal note:Producing package of certified design
18 Every person who produces a package of a certified design must
(a) produce the package in accordance with the requirements set out in the certificate; and
(b) clearly mark the package with the certificate number, design number and serial number.
Marginal note:Application for registration
19 (1) A person who intends to use a package of a certified design must apply to the Commission to register their use of the package.
Marginal note:Information for registration
(2) The Commission must register the applicant’s intended use of the package on receipt of an application containing the following:
(a) the applicant’s contact information, including, as applicable, their name, postal address, email address, telephone number and fax number;
(b) the name of a person who can be contacted for transport purposes;
(c) the number of any licence that the applicant holds in respect of the contents of the package;
(d) the number of any applicable approval issued by a foreign competent authority in accordance with the IAEA Regulations;
(e) the package’s design and serial numbers; and
(f) 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.
Marginal note:Confirmation
(3) An applicant may use the package only if they have received confirmation from the Commission that their use of the package has been registered.
Marginal note:Producing special form radioactive material
20 (1) Every person who produces special form radioactive material must
(a) use a certified design and produce the material in accordance with the requirements set out in the certificate; and
(b) clearly mark the material, or any source holder to which it is permanently attached, in a unique, legible and durable manner.
Marginal note:Transporting special form radioactive material
(2) 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.
Marginal note:Prior approvals
(3) 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.
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