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Vol. 137, No. 30 — July 26, 2003 Regulations Amending Certain Regulations made under the Nuclear Safety and Control ActStatutory Authority Nuclear Safety and Control Act Sponsoring Agency Canadian Nuclear Safety Commission REGULATORY IMPACT ANALYSIS STATEMENT Summary This Regulatory Impact Analysis Statement (RIAS) deals with the inclusion into the Packaging and Transport of Nuclear Substances Regulations (PTNSR) of the latest version of the International Atomic Energy Agency's (IAEA) Regulations for the Safe Transport of Radioactive Material (IAEA Regulations), 1996 edition (revised), No. TS-R-1 and with two consequential amendments to the General Nuclear Safety and Control Regulations (GNSCR). The proposed changes are designed to complement existing regulatory practices. For the most part, the amendments update existing references made to the IAEA Regulations throughout the PTNSR and introduce a number of new requirements, such as Type C packages for air transport of large quantities of nuclear substances and the certification of a new type of nuclear materials called Low Dispersible Radioactive Materials (LDRM) as discussed later in this RIAS. Background As Canada's nuclear regulatory agency, the Canadian Nuclear Safety Commission (CNSC) regulates all activities related to the use of nuclear energy and nuclear substances in Canada including the packaging and transport of nuclear substances. The regulation of the packaging and transport of nuclear substances is a jointly shared responsibility with Transport Canada. The CNSC regulations primarily are concerned with health, safety, security and protection of the environment related to the special characteristics of nuclear substances. These regulations are complemented by those issued by Transport Canada which have general application to the transport of all classes of dangerous goods. All industrialized countries use the recommendations of the IAEA to regulate the packaging and transport of radioactive materials. Canada is no exception. Canada applied the requirements of the IAEA Regulations as the basis for regulating the transport of radioactive nuclear substances since their initial adoption in the international community. The current PTNSR were enacted in May 2000, SOR/DORS/2000-202, as one of nine Regulations made under the Nuclear Safety and Control Act (NSC Act) and are based on the 1985 edition (as amended in 1990) of the IAEA Regulations. The IAEA is committed to periodically updating and revising their regulations to ensure that they remain relevant, useful and suitable for worldwide use. In keeping with this commitment, the IAEA issued a 1996 edition of the Regulations for the Safe Transport of Radioactive Material, known as TS-R-1, that was scheduled for implementation commencing in 2001. The main purpose of this amendment to the PTNSR is to update the regulatory requirements to the 1996 edition of the IAEA Regulations. The CNSC, including its predecessor the Atomic Energy Control Board (AECB), has been a major participant in the development of the IAEA Regulations. In formulating a Canadian position on radioactive materials transportation issues, the CNSC has communicated regularly with Transport Canada and major stakeholders. Transport Canada is normally represented at transport related IAEA meetings, and experts from the nuclear industry have routinely participated in IAEA technical meetings as part of the Canadian delegation. This participation has ensured that Canadian needs and viewpoints are taken into consideration in the development of the international regulatory consensus standard. The IAEA Regulations are used worldwide to facilitate the harmonized and safe transport of radioactive materials. The IAEA transport requirements are incorporated into the United Nations (UN) Recommendations for Transport of Dangerous Goods — Model Regulations which form the basis of many other national and international regulations including those of the International Civil Aviation Organization (ICAO) in their Technical Instructions for the Safe Transport of Dangerous Goods by Air and the International Maritime Organization (IMO) in their International Maritime Dangerous Goods Code. In Canada, Transport Canada's Transport of Dangerous Goods Regulations (TDG) references both modal requirements for air and sea transport. The changes that were introduced in the 1996 edition of the IAEA Regulations (TS-R-1) consist of additional requirements for radiation protection and quality assurance (QA) programmes, an update to the radiological basis of the regulations, the introduction of new packages and material types and a complete renumbering of the paragraph sequences. Existing PTNSR paragraph references to the IAEA Regulations require change even where the requirement is essentially unchanged. Changes to the PTNSR References to IAEA Paragraph Numbers A large number of changes proposed in the PTNSR are consequential to the renumbering of paragraphs between the 1985 edition and 1996 edition of the IAEA Regulations. Where these paragraph reference revisions do not materially change current requirements, and consequently have little or no impact, they are not discussed further in this RIAS. (a) Alternative: An alternative to referencing the IAEA paragraph numbers would be to place the words of the requirement directly into the PTNSR. This would eliminate the need to change a regulatory provision in the PTNSR regardless of the position of the requirement in the IAEA documents. The drawback to this approach is the need to recast the technical requirements in the IAEA document into suitable regulatory language. The correspondence between the regulatory provision and the corresponding IAEA clause would also be lost. In addition, the insertion of those requirements that are more than paragraph reference number changes may nonetheless result in consequential changes to PTNSR provisions that do not require material change. This may result in even more changes than would result by simply changing paragraph references. (b) Costs: There will be some costs associated with changing documentation and training material to reflect the revised references. In addition, safety assessments may need to be updated to reflect the new IAEA reference numbers. These costs are not expected to be great. These documents may need to be revised anyway due to materially changed requirements of this amendment. It is anticipated that the IAEA paragraph numbering will remain relatively stable in the foreseeable future. Changing the references should, therefore, not result in recurring expenses. (c) Benefits: The revised references correspond to those being used internationally and should result in benefits to those carrying out international shipments. For example, a shipper may be able to more easily show that by meeting a Canadian requirement they are also meeting those of another country or vice versa. There is also a body of supporting information that provides explanation and guidance on the IAEA requirements. As these are generally keyed on or refer to the IAEA paragraph number, this information would be readily accessible to users of a revised PTNSR. Definition of Radioactive Material for Transport A major consideration in the latest revision of the IAEA Regulations was the adoption of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (BSS) which reflects a consensus of the international community on radiation protection. The acceptance of these standards resulted in changes to the transport definition of radioactive material. The former definition of radioactive material for transport purposes, irrespective of the radionuclide, was 70 kBq/kg, where kBq/kg is defined as the activity (expressed in Becquerels, or disintegration per second) per unit mass of the material in which the radionuclides are essentially uniformly distributed. A radionuclide is a radioactive isotope of an element that emits nuclear radiation energy. The new transport definition of radioactive material is radionuclide dependent, taking into account the different types of radiation, energies and chemical forms applicable to the radionuclides contained in the material and their potential biological effect on persons. Radionuclides that present smaller risks to health and safety have higher limits and those that present higher risks have lower limits than the former definition of radioactive material for transport, thereby keeping the overall risk to a consistent low level, in accordance with the IAEA BSS. (a) Alternative: An alternative to the new definition would be to retain the old definition of radioactive material in the PTNSR. In many cases the specific radioactivity will be higher than the old limit; however, in a significant number of cases the new limits are lower. Where the new limits are higher, retaining the old limits would prevent transporters from taking advantage of the justifiably relaxed limits. This could lead to increased costs for these shippers versus their international counterparts. Where the new limits are lower, retention of the old limit is not justified from a radiological risk perspective. (b) Costs: There will be some additional costs to fully characterize materials that contain radionuclides to determine if they fall within the definition of radioactive material for transport. For materials within the nuclear industry, this should already have been completed so the incremental cost for analysis should be small, if any. Once the material is characterized, some materials that were formerly considered radioactive for transport may turn out to be below the new definition and consequently exempted from the PTNSR and vice versa. Overall the cost savings for transporting material no longer considered radioactive should offset the additional cost to transport as radioactive material that which previously was not considered so. For materials outside the nuclear industry, mostly involving natural materials, there may be a significant cost to analyse the radioactivity in the material and to calculate whether the material is above or below the definition of radioactive material. Following the example set by the IAEA, which has a separate higher limit for natural materials, it is proposed to allow continued use of the current limit of 70 kBq/kg for natural materials only. Most natural material that is less than 70 kBq/kg would likely also be below the IAEA's higher limits for these materials; however, the cost to perform new analyses, to demonstrate this, may be significant. Given this, retention of the old limit for natural materials is deemed appropriate. Companies that wish to take advantage of the higher IAEA limits can still do the assessment, with the cost saving if the material is determined to be below the new limits possibly offsetting the cost of assessment. (c) Benefits: The new definition of radioactive material is scientifically based and has international acceptance. Adopting this definition will allow for a consistent threshold based on radiation protection considerations and will be consistent with international norms and will facilitate trade. Exemptions to the PTNSR The current PTNSR contain a number of exemptions that have been expanded to cover changes incorporated by the IAEA Regulations and related CNSC regulations. Consumer items such as smoke detectors, tritium safety signs or other radiation devices that are exempt from CNSC licensing by the Nuclear Substances and Radiation Devices Regulations (NSRD) are also exempted from most transport requirements. The previous limit of ten such devices in a consignment has been removed. These exemptions for consumer products that have a low risk hazard is a more practical and efficient application of the Regulations. (a) Alternative: An alternative would be no exemptions. As virtually all substances have some radionuclides, the transportation regulations would apply even where the hazard is trivial. In this case, except for transport, most of these materials would not be subjected to regulation or licensing. In the extreme, persons undergoing diagnostic or therapeutic treatment with radioisotopes could be subject to the regulations due to the quantity of nuclear substances present in their body. Clearly, this alternative would be impractical and unreasonable. (b) Costs: There are no direct costs associated with these exemptions, only cost savings. (c) Benefits: Items of low risk are excluded from the regulations allowing resources to be directed to areas of more significant risk. A1 and A2 Values The revision of the radiological models has resulted in an adjustment of the A1 and A2 values listed in the IAEA transport regulations. A1 and A2 values are measures of radioactivity for each radioisotope that are set in the IAEA Regulations and are used to establish the activity limits of special form and normal form radioactive materials. Special form radioactive material is material that is designed to remain intact under severe mechanical and thermal test conditions and has to be approved by a government agency. In many cases, the A1 and A2 values listed remain essentially unchanged. Some have either increased or decreased based on more recent information regarding their potential effect on persons in certain situations. Two variations to these new limits were included in the proposed regulations. In the case of molybdenum-99, the existing variation to the A2 value is retained for harmonization with the USA. In the case of californium-252, the A1 value is modified to correct an error in the IAEA regulations that will be remedied in the next publication of TS-R-1 in late 2003. (a) Alternative: An alternative would be to develop a separate radiological risk evaluation methodology and derive different limits. As these limits would be applicable only in Canada and would not have international peer review and consensus, these alternative values would likely not be accepted anywhere else. Given the international aspect of transport, values made in Canada could prove to be a source of difficulty for transporters. (b) Costs: There may be some costs associated with this change for those transporting radioisotopes with values that have decreased and potential cost savings for those transporting radioisotopes with values that have increased. Overall, these costs should offset each other resulting in no net cost increase or decrease. (c) Benefits: Using the revised values keeps Canada abreast with those values being used worldwide and takes advantage of the most current radiological assessment methodologies and data available. Uranium Hexafluoride Package Certification New certification requirements have been added for packages containing uranium hexafluoride (UF6). The conversion of uranium to uranium hexafluoride is an intermediate step in the production of enriched nuclear fuel used in power reactors. Canadian shippers of UF6 will be required to register and have certified package designs for transport. Foreign competent authority approved H(U)-96 packages will not require Canadian certification. The cylinders used to transport UF6 are of a standardized design in accordance with standards published by the American National Standards Institute (ANSI) and the International Organization for Standardization (ISO). In IAEA TS-R-1 there are new requirements aimed at minimizing the chance of a rupture of these cylinders in a severe transport fire accident. In order to meet the TS-R-1 requirements some package designs will require modification. (a) Alternative: An alternative would be not to implement the new performance requirements and the need for certification. As most shipments of UF6 in Canada are export, import or transit shipments, the new requirements are essential. (b) Costs: There may be some costs associated with this change, but due to the international nature of these shipments, these costs are unavoidable. (c) Benefits: The benefit is harmonization with international norms. Type C Packages, Low Dispersible Radioactive Material (LDRM) and Type B Limits for Air Transport Type C Packages The IAEA TS-R-1 introduces a new package type for the transport of large quantities, in excess of 3 000 A1 or A2, of radioactive material by air. This new Type C package must meet strict requirements that will minimize radiological consequences in the event that an aircraft transporting a large quantity of radioactive material is involved in a crash. These requirements take into account the higher speeds of air transport and onboard fuel load capable of subjecting a package to a significant thermal environment. Type C packages will require certification by the CNSC before being used. Low Dispersible Radioactive Materials (LDRM) One of the main hazards of a package failure in an aircraft accident is the potential for wide dispersion of material that presents an internal radiation hazard if inhaled or ingested. Material with low dispersibility presents a lower hazard even when inadvertently released from the package. With this in mind, a new type of material called Low Dispersible Radioactive Material (LDRM) is defined and included in the IAEA TS-R-1. It can be transported in a Type B package, even in large quantities, and as its name implies, it is not very dispersible and therefore will mostly settle close to the package. LDRM will require certification by the CNSC before being used. Type B Packages With the introduction of the Type C package, the IAEA TS-R-1 also imposed content limits for Type B packages when used for air transport. The IAEA is currently convening a coordinated research programme (CRP) into air accident severity and package survivability, in which Canada is a participant. Canadian manufacturers have also expressed a concern that the introduction of the Type C packages would be premature in the PTNSR, as the research had not been completed by the IAEA. Given the probability that the IAEA requirements may change as a result of its CRP, and in response to Canadian manufacturer concerns, it is proposed in the amendment to the PTNSR to exclude, for domestic shipments, the IAEA TS-R-1 limits for Type B packages transported by air. Type B packages would still continue to be subject to the limits included in their approval certificates issued by the CNSC. (a) Alternatives: An alternative would be to not implement any special requirements for the air transport of large quantities of nuclear substances. In this case, the mechanism to certify Type C and LDRM would not be established in law and Canadian transporters would be at a disadvantage without these certificates when transporting internationally by air. Alternately, they would have to seek these approvals from regulatory bodies in other countries. A second alternative would be to adopt requirements similar to the USA's plutonium by air requirements which would be limited only to that material. As the USA's requirements were considered by the IAEA but not adopted in favour of the Type C requirements, which have general application to all nuclear materials, there is little likelihood for wide international acceptance of the USA concept. (b) Costs: The cost to develop and have certified a Type C package or LDRM will be significant. It is estimated that design and certification of a single Type C package could be in the range of $1,000,000.00 in Research and Development costs. On the other hand, the number of Type C applications will likely be small. The temporary relief for domestic air transport of Type B packages containing large quantities may alleviate this cost until the issue is clarified internationally. (c) Benefits: Inclusion of the Type C and LDRM requirements will bring Canadian regulations up to the current standard and permit the certification of these items. Placarding (hazardous material warning signs posted on the outside of vehicles and containers) There are a number of differences between the placarding requirements in Transport Canada's Transport of Dangerous Goods Regulations (TDG) and those in the IAEA TS-R-1. In order to harmonize with the international requirements of TS-R-1, it had been proposed to include general placarding requirements in the amendment to the PTNSR. Due to numerous comments received during pre-consultation in January 2003, these proposed placarding provisions in the PTNSR will be dropped. Placarding in the PTNSR will only be retained in special cases, such as for exposure devices where relief from labelling has been provided in the PTNSR. In all other cases the placarding requirements of the TDG regulations will apply. (a) Alternative: The alternative of requiring placards in the PTNSR was considered and proposed. It was dropped in response to comments that the mix of general placarding requirements in other related regulations was confusing. (b) Costs: The cost associated with the limited placarding requirements retained in the proposed amendments to the PTNSR will be small. (c) Benefits: The remaining placarding requirements in the proposed amendments allow rapid identification of those shipments where relief has been provided from labelling. This will aid in identification of hazard in the event that emergency response is needed. Criticality Safety Criticality safety requirements were rewritten in the IAEA Regulations to improve clarity. The definition of fissile material is changed to mean certain isotopes of uranium and plutonium that could present a criticality risk in transport. There is a new label containing the Criticality Safety Index (CSI) required for non-exempted shipments of fissile material. (a) Alternative: There are no practical alternatives to these requirements. (b) Costs: The impact of these changes on shippers is minimal, as Canadian power reactors use natural uranium, which is not considered as a fissile material for transport purposes. (c) Benefits: The benefit is harmonization with international requirements and provision for criticality safety of fissile materials during transport. Consequential Changes to the GNSCR Two complementary revisions are required to the General Nuclear Safety and Control Regulations (GNSCR). Naturally Occurring Nuclear Substances The cost-benefit of excluding naturally occurring nuclear substances with specific activities below 70 kBq/kg is as previously discussed under the topic "Definition of Radioactive Material for Transport." Paragraph 10(a) of the GNSCR deals with the transport of naturally occurring nuclear substances and requires amending to include this exclusion. Low Dispersible Radioactive Materials (LDRM) An amendment to paragraph 20(a) of the GNSCR is required to include LDRM in the description of prescribed equipment for certification purposes. The cost-benefit of including LDRM in the regulations was previously discussed under the topic "Type C Packages, Low Dispersible Radioactive Material (LDRM) and Type B Limits for Air Transport." Alternatives to Regulation The Nuclear Safety and Control Act allows the Commission to make regulations, with the approval of the Governor in Council, respecting packaging and transport of nuclear substances. A number of possible alternatives were considered in assessing whether to adopt the latest IAEA Regulations. These consisted of: repealing of existing regulations, maintaining of the status quo, implementation as a standard, implementation by single reference, or implementation via other statutes. Repeal of existing regulations In the absence of any regulation respecting the packaging and transport of nuclear substances, shippers would be free to decide which requirements to apply. Some may choose to implement minimal standards whereas others may use very stringent ones. In the short term, those using minimal standards may benefit from decreased expenses in this area. On the other hand, these would likely be offset, in the longer term, by the requirement for response to more frequent spills and dangerous occurrences and the need for remediation of those consequences and liability issues. There could also be an increase in detrimental health, safety and environmental consequences for those outside the industry. Those imposing stringent standards likely would initially be at a competitive disadvantage with respect to costs in this area. In the longer term these companies may see a competitive advantage, if they were able to remain fiscally viable in the short term. In addition, to protect against all conceivable situations, the level of packaging and controls required may be such that it results in a general unavailability of nuclear substances to medicine and industry. As transport is a cooperative activity involving many players such as consignors, carriers, agents and consignees, differences in standards applied by each party could result in delays, errors, rejection of shipments and other undesirable situations. Therefore, there is a need for a consistent set of requirements that provides for an acceptable level of safety and facilitates harmonization. Status Quo The IAEA TS-R-1 was published in 1996 and scheduled for implementation starting in 2001. Failure to update the PTNSR would result in out-of-date requirements being applied in Canada. As most of the world transitions to the new requirements, Canadian shipments would increasingly be out of step with what is required internationally. This may affect the acceptance of shipments abroad. Canadians would be faced with complying with two standards, current PTNSR for domestic use and the IAEA TS-R-1 for international transport. The variation between old and new requirements could also create an increased administrative burden that raises the cost of transport and the potential for errors. Therefore, an update of the current regulations is preferable to the status quo. Implementation as a Standard The IAEA is an international organization under UN auspices whose constituent member countries developed and agreed to the specific IAEA TS-R-1 requirements. In keeping with its publication, GS-R-1 Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, the IAEA expresses an expectation that a "legislative and statutory framework shall be established to regulate the safety of facilities and activities", including transport activities, as a prerequisite for safety. The CNSC regulatory documents program indicates that "document types such as regulatory policies, standards, guides, notices and procedures do not create legally enforceable requirements." Implementation of the IAEA TS-R-1 as a standard would not create any legally binding or enforceable requirements. The potential for deviations from the internationally accepted norms for transport could lead to difficulties and conditions that have negative consequences. Therefore, in order to facilitate safety, meet international expectations and to assure the harmonization of transport requirements, this alternative to regulation is not suitable. Implementation by single reference IAEA TS-R-1 indicates that although its requirements may prescribe a particular action, "the responsibility for carrying out the action is not specifically assigned to any particular legal person." The inclusion of the IAEA TS-R-1 into Canadian legislation by single reference to the entire document could leave undefined the crucial assignment of responsibility for action. This could lead to situations with negative consequences and difficulty with respect to compliance and compliance assurance. Therefore, the implementation of this alternative is not viable. Implementation via other statutes In Canada, as in many other countries, there are separate governmental organizations that are responsible for regulating the transport and the nuclear energy sector. This creates a potential for duplication and overlap between the requirements of the organizations involved when it comes to the common subject of the transport of nuclear substances. This concern was recognized and is addressed between the CNSC and Transport Canada (TC) via a Memorandum of Agreement (MOA) which delineates which areas of the transport of nuclear substances are regulated by the respective organizations. The division of responsibility between TC and the CNSC is such that those areas common to the transport of all dangerous goods are regulated by TC and those that are specific to nuclear material are regulated by the CNSC. The two organizations agree to cooperate, but in each specific area of expertise only one organization has the lead while the other provides support. Simply stated, the CNSC regulates those areas of transport that affect the users and producers of radioactive nuclear substances, whereas TC regulates the carriers of those substances between the producers and users. An example of this is the issue of placarding discussed elsewhere in this RIAS. In this area TC has the lead, as it mainly affects carriers. As a result of comments, including those from TC, the CNSC has removed the proposed general placarding requirements from the PTNSR and is working with TC regarding differences from international requirements. The PTNSR made by the CNSC is one of nine regulations made pursuant to the Nuclear Safety and Control Act that control the development, production and use of nuclear energy. When transport approvals and licenses are issued under the PTNSR, use is made of CNSC integrated information available regarding licensed users and producers of nuclear energy and nuclear substances. The PTNSR are integrally linked to all the other CNSC regulations made under the Act. Implementation of all the transport requirements under the Transport of Dangerous Goods Act (TDG) and regulations would require duplication of these other requirements under the TDG Act. The degree of coordination that would be required between the two organizations when issuing approvals and licenses could result in increased costs and delays. It is considered more efficient and effective to continue the division of responsibility between the respective federal government organizations. From the foregoing considerations it is evident that there are no suitable alternatives to adopting the IAEA Regulations (Revised) No. TS-R-1, 1996 edition into the PTNSR. Consultation A broad based consultation of stakeholders and the transport industry was undertaken in January 2003. Information was made available in electronic format on the CNSC Web site and on paper to interested parties. More than 26 000 Canadian companies and organizations were contacted directly to notify them of the proposed changes to the PTNSR and to solicit comments. A significant number of these organizations consisted of emergency first responders whose interests are primarily related to the identification of hazardous materials in general and to shippers involved in the transport of hazardous materials other than nuclear substances. In addition, the CNSC addressed separate consultation notices to Transport Canada, Canada Customs and Revenue Agency and Canada Post Corporation, agencies that are primarily concerned with the regulation and control of hazardous materials within the confines of national boundaries. Presentations were made in November 2002 and in January and March 2003 to the Canadian Nuclear Association (CNA) whose membership represents the nuclear industry in Canada. The comments from the January 2003 consultation reflected the views of a broad sector of the nuclear industry, including: cancer research, mining, servicing and disposal, nuclear fuel production, energy, medical and industrial isotope manufacturing, National Defence, Transport Canada and Canada Post Corporation. There were no comments received from commercial transport carriers or members of the general public. This is attributed to the fact that the majority of carriers transporting hazardous materials are not involved in the transport of nuclear substances. In total, 160 concerns were identified ranging in scope from minor administrative issues to the identification of requirements that, if implemented, would have resulted in unnecessary controls and expenditures. Each comment was carefully considered and many were accepted either partially or fully. Some were not accepted for a variety of reasons that are reported in a Consultation Summary Report that was published on the CNSC Web site. Approximately 30 additional changes were made to the proposed amendments to the regulations and to the current PTNSR as a result of the pre-consultation. The input of the commenting organizations and individuals has helped to improve the quality of the proposed regulation amendment. As a direct result of this consultation, a number of changes were made to the proposed regulations to address the comments and concerns of the respondents. The following is a list of significant changes. — The requirement for placarding was eliminated in preference for the TDG scheme, with only a couple of exceptions; — The information in shipping documentation was simplified to that being used internationally; — The limit on Type B packages transported by air domestically was removed pending clarification of air transport issues currently being studied by the IAEA; — The requirement to submit shipping information on re-issue of approval certificates was dropped; — The requirement to check all packages on receipt for contamination in excess of the limits was removed; — The requirements for the transport of radioactive material by post, both domestically and internationally, were added. However, the acceptance of radioactive material packages for transport by post still remains the prerogative of Canada Post Corporation; — The exclusion of all material having a specific radioactivity less than 70 kBq/kg was limited to naturally occurring nuclear substances; and — A number of other minor changes to improve clarity and remove duplication of requirements were made. In general, the proposed amendment to the PTNSR was favourably received, based on the comments. Benefits and Costs Benefits The adoption of the IAEA TS-R-1 into the PTNSR will bring Canadian requirements into alignment with those being used internationally. This will facilitate the export and import of nuclear substances by Canadian manufacturers and transporters. By adopting the latest standards and requirements, the CNSC provides Canadian shippers with the same regulatory control as international manufacturers and shippers and, more importantly, provides additional assurances to the Canadian public that all import and export shipments will conform to both domestic and international regulations. Canada, as a major exporter of medical and industrial radioisotopes and a supplier and processor of uranium for nuclear power, is obligated to promote the use of these strong international standards. Canada's membership in the International Atomic Energy Agency provides access to resources important to the appropriate regulation of the nuclear industry in Canada. By its active participation in the development of international regulations, standards and guidance, the CNSC staff contribute and gain invaluable experience in the application and understanding of international requirements. Costs The cost of implementation of the revised PTNSR is assessed to be limited. Where the costs may be high, such as in the development of air transportable packages for large quantities of nuclear substances, the cost cannot be avoided if Canada is to stay in step with international norms and remain competitive. Nonetheless, there is temporary relief in the PTNSR for transport within Canada; however, this does not alleviate the need to meet Transport Canada's requirements. The IAEA TS-R-1 is an evolution of requirements for the safe transport of radioactive materials. In many cases where the provisions of the 1985 edition of the IAEA Regulations were deemed to be adequate, they have not been significantly altered in TS-R-1. Consequently, in many cases, the move to TS-R-1 should not result in significant cost, although there may be some minor costs resulting from the need to update documentation. The largest cost factor projected by respondents in pre-consultation was attributed to the additional requirement of performing contamination checks on receipt of packages containing nuclear substances. This concern was addressed by removing this additional control from the draft regulation and by retaining the need to perform contamination checks prior to sending the package and on receipt of packages that show clear evidence of tampering or damage. The anticipated costs for implementing these revised regulations are principally administrative in nature. Shippers and carriers will have to review and revise their internal documentation and staff will have to be trained accordingly. Assuming 200 carriers who transport radioactive material and an estimated cost of $2,000 for staff training would result for a total expenditure of $400,000. Similar costs may be encountered by the approximate 3 000 CNSC licensees who possess radiation devices and nuclear substances. However, the majority of these licensees are not routinely involved in the transport of nuclear substances consequently their cost of implementation is not anticipated to be significant. The harmonizing of documentation and placarding requirements with the TDG Regulations should help to offset some of the incremental costs incurred. Environmental Impact There are no adverse environmental effects anticipated from the implementation of these revised regulations. The current PTNSR have been in force since 2000 and the changes introduced by the new IAEA Regulations represent an update to existing practices. The revised radiological basis for the Regulations ensures the most appropriate levels of safety in respect to the hazard. The newly introduced requirements for uranium hexafluoride packages will improve environmental considerations through better protection and increased package inspections. The new air transport requirements for large quantities and fissile materials will provide an additional level of protection. Regulatory Burden The change in the regulatory burden imposed through these amendments to the PTNSR is not anticipated to be significant. Many of the additional certification requirements are unavoidable if Canada is to remain in step with international requirements and is to take advantage of the latest advances in radiation protection. For those nuclear substances and radiation devices exempted from CNSC licensing action, the regulatory burden will be lessened as their transport requirements have been relaxed. Security The PTNSR are primarily concerned with the risks to health and safety of persons and the protection of the environment as they relate to domestic and international packaging and transport of nuclear substances. This RIAS does not address security issues as these are regulated by other regulations made under the NSC Act. Compliance and Enforcement Compliance and enforcement policies and practices do not require any significant modification to accommodate the proposed amendments to the PTNSR. Details concerning new package and material types, revised limits and other changes will need to be incorporated into documentation and procedures, and some additional training will be required. The risk-based enforcement strategy of annual reporting, inspections, licensing and legal actions used by the CNSC under the NSC Act and Regulations should be unaffected. Phillip Eyre, Packaging and Transport Licensing Division, Directorate of Nuclear Substances Regulation, Canadian Nuclear Safety Commission, 280 Slater Street, P.O. Box 1046, Station B, Ottawa, Ontario K1P 5S9, (613) 995-0537 (Telephone), (613) 995-5086 (Facsimile), eyrep@cnsc-ccsn.gc.ca (Electronic mail). Notice is hereby given that the Canadian Nuclear Safety Commission, pursuant to subsection 44(1) (see footnote a) of the Nuclear Safety and Control Act (see footnote b) , proposes to make the annexed Regulations Amending Certain Regulations made under the Nuclear Safety and Control Act. Interested persons may make representations in writing with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Phillip Eyre, Packaging and Transport Licensing Division, Directorate of Nuclear Substances Regulation, Canadian Nuclear Safety Commission, 280 Slater Street, P.O. Box 1046, Station B, Ottawa, Ontario K1P 5S9. Ottawa, July 24, 2003
EILEEN BOYD
REGULATIONS AMENDING CERTAIN REGULATIONS MADE UNDER THE NUCLEAR SAFETY AND CONTROL ACT GENERAL NUCLEAR SAFETY AND CONTROL REGULATIONS 1. Paragraph 10(a) of the General Nuclear Safety and Control Regulations (see footnote 1) is replaced by the following: (a) in the case of a nuclear substance having a specific activity greater than 70 kBq/kg, the provisions that govern the transport of nuclear substances; 2. Paragraph 20(a) of the General Nuclear Safety and Control Regulations is replaced by the following: (a) a package, special form radioactive material and low dispersible radioactive material, as defined in subsection 1(1) of the Packaging and Transport of Nuclear Substances Regulations; PACKAGING AND TRANSPORT OF NUCLEAR SUBSTANCES REGULATIONS 3. (1) The definitions "IP-1 package", "IP-2 package", "IP-3 package" and "quality assurance program" in subsection 1(1) of the Packaging and Transport of Nuclear Substances Regulations (see footnote 2) are repealed. (2) The definitions "A1" and "A2", "certificate", "consignee", "consignment", "containment system", "contamination", "conveyance", "depleted uranium", "excepted package", "fissile material", "IAEA Regulations", "LSA-I material", "LSA-III material", "natural uranium", "packaging", "radioactive material", "SCO-I", "SCO-II", "special arrangement", "special form radioactive material", "specific activity", "Type A package", "Type B package", "unirradiated thorium" and "unirradiated uranium" in subsection 1(1) of the Regulations are replaced by the following: "A1" and "A2" have the respective meanings assigned to those terms by paragraph 201 of the IAEA Regulations. (A1 et A2) "certificate" means a document issued by the Commission or by a designated officer authorized under paragraph 37(2)(a) of the Act, indicating that a package design, a design for special form radioactive material or a design for low dispersible radioactive material is certified. (homologation) "consignee" means a person who receives a consignment or a person to whom a consignment is being or is intended to be transported. (destinataire) "consignment" has the meaning assigned to that term by paragraph 211 of the IAEA Regulations. (envoi) "containment system" has the meaning assigned to that term by paragraph 213 of the IAEA Regulations. (enveloppe de confinement) "contamination" has the meaning assigned to that term by paragraph 214 of the IAEA Regulations. (contamination) "conveyance" has the meaning assigned to that term by paragraph 217 of the IAEA Regulations. (moyen de transport) "depleted uranium" has the meaning assigned to that term by paragraph 246 of the IAEA Regulations. (uranium appauvri) "excepted package" means a package that meets the requirements of paragraph 515 of the IAEA Regulations. (colis excepté) "fissile material" has the meaning assigned to that term by paragraph 222 of the IAEA Regulations. (matière fissile) "IAEA Regulations" means the Regulations for the Safe Transport of Radioactive Material, 1996 Edition (Revised), being Safety Standards Series No. TS-R-1 (ST-1, Revised) published by the International Atomic Energy Agency, as modified for the purposes of these Regulations by subsections (2) and (3). (Règlement de l'AIEA) "LSA-I material" means
(b) radioactive material for which the A2 value is unlimited, excluding fissile material in quantities not excepted under paragraph 672 of the IAEA Regulations and ores that are not described in paragraph (a); (c) unirradiated thorium or unirradiated natural or depleted uranium concentrates; (d) mill tailings, contaminated earth, concrete, rubble, other debris and activated materials in which the radioactive material is essentially uniformly distributed and the average specific activity does not exceed 10-6 A2/g; or (e) other radioactive material in which the activity is distributed throughout and the estimated specific activity does not exceed 30 times the values for activity concentration specified in paragraphs 401 to 406 of the IAEA Regulations, excluding fissile material in quantities not excepted under paragraph 672 of those Regulations. (matière FAS-I) "LSA-III material" means material described in paragraph 226(c) of the IAEA Regulations that conforms to paragraph 601 of those Regulations. (matière FAS-III) "natural uranium" has the meaning assigned to that term by paragraph 246 of the IAEA Regulations. (uranium naturel) "packaging" has the meaning assigned to that term by paragraph 231 of the IAEA Regulations. (emballage) "radioactive material" means a nuclear substance that is a material described in paragraph 236 of the IAEA Regulations. (matière radioactive) "SCO-I" means a surface contaminated object, as defined in paragraph 241(a) of the IAEA Regulations. (OCS-I) "SCO-II" means a surface contaminated object, as defined in paragraph 241(b) of the IAEA Regulations. (OCS-II) "special arrangement" has the meaning assigned to that term by paragraph 238 of the IAEA Regulations. (arrangement spécial) "special form radioactive material" means a material described in paragraph 239 of the IAEA Regulations that conforms to paragraphs 602 to 604 of those Regulations. (matière radioactive sous forme spéciale) "specific activity" has the meaning assigned to that term by paragraph 240 of the IAEA Regulations. (activité spécifique) "Type A package" means a package that is designed to meet the requirements of paragraphs 413, 414 and 633 of the IAEA Regulations. (colis du type A) "Type B package" means a package that is designed to meet the requirements of paragraph 415 and paragraph 650 or 665 of the IAEA Regulations. (colis du type B) "unirradiated thorium" has the meaning assigned to that term by paragraph 244 of the IAEA Regulations. (thorium non irradié) "unirradiated uranium" has the meaning assigned to that term by paragraph 245 of the IAEA Regulations. (uranium non irradié) (3) The definition "exclusive use" in subsection 1(1) of the English version of the Regulations is replaced by the following: "exclusive use" has the meaning assigned to that term by paragraph 221 of the IAEA Regulations. (utilisation exclusive) (4) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order: "confinement system" means the assembly of fissile material and packaging components intended to preserve criticality safety. (système d'isolement) "criticality safety index" has the meaning assigned to that term by paragraph 218 of the IAEA Regulations. (indice de sûreté-criticité) "low dispersible radioactive material" means a material described in paragraph 225 of the IAEA Regulations that conforms to paragraphs 605 and 712 of those Regulations. (matière radioactive faiblement dispersable) "quality assurance" has the meaning assigned to that term by paragraph 232 of the IAEA Regulations. (assurance de la qualité) "transport index" has the meaning assigned to that term by paragraph 243 of the IAEA Regulations. (indice de transport) "Type C package" means a package that is designed to meet the requirements of paragraphs 417 and 667 of the IAEA Regulations. (colis du type C) "Type H(M) package" means an excepted package, Type IP-1 package, Type IP-2 package, Type IP-3 package or Type A package that meets the requirements of paragraph 632 of the IAEA Regulations and contains more than 0.1 kg of uranium hexafluoride material that is not fissile material. (colis du type H(M)) "Type H(U) package" means an excepted package, Type IP-1 package, Type IP-2 package, Type IP-3 package or Type A package that meets the requirements of paragraph 629 of the IAEA Regulations and contains more than 0.1 kg of uranium hexafluoride material that is not fissile material. (colis du type H(U)) "Type IP-1 package" means a package that is designed to meet the requirements of paragraphs 411 and 621 of the IAEA Regulations. (colis du type CI-1) "Type IP-2 package" means a package that is designed to meet the requirements of paragraphs 411 and 412 of the IAEA Regulations and (a) paragraph 622 of those Regulations; or (b) the requirements for a Type IP-2 package in paragraphs 624 to 628 of those Regulations. (colis du type CI-2) "Type IP-3 package" means a package that is designed to meet the requirements of paragraphs 411 and 412 of the IAEA Regulations and (a) paragraph 623 of those Regulations; or (b) the requirements for a Type IP-3 package in paragraphs 625 to 628 of those Regulations. (colis du type CI-3) (5) Subsection 1(1) of the French version of the Regulations is amended by adding the following in alphabetical order: « usager inscrit » Personne ayant reçu de la Commission la confirmation que l'usage qu'elle fait d'un colis est inscrit conformément à l'article 14. (registered user) « utilisation exclusive » S'entend au sens du paragraphe 221 du Règlement de l'AIEA. (exclusive use) (6) Paragraphs 1(2)(a) and (b) of the Regulations are replaced by the following: (a) the definition "LSA-I" in paragraph 226(a) of the IAEA Regulations is replaced by the definition "LSA-I material" in subsection (1); (b) the definition "LSA-II" in paragraph 226(b) of the IAEA Regulations is replaced by the definition "LSA-II material" in subsection (1); (7) Paragraph 1(2)(c) of the Regulations is repealed. (8) Paragraphs 1(2)(d) to (i) of the Regulations are replaced by the following: (d) the A1 value for californium 252 (Cf-252) shown in Table I of the IAEA Regulations is replaced by 1 × 10-1 (TBq) and the A2 value for molybdenum 99 (Mo-99) is replaced by 8 × 10-1 (TBq); (e) the industrial package types listed in the column headed "Not under exclusive use" in Table IV of the IAEA Regulations are replaced by "Type IP-3"; (f) the phrase "other than ores containing only naturally occurring radionuclides" in paragraph 523(a) of the IAEA Regulations is deleted; (g) figures 2 to 4, 6 and 7 in Section V of the IAEA Regulations are replaced by the corresponding figures illustrating the labels, the placard for substances of Class 7 and the orange panel specified in the Transportation of Dangerous Goods Regulations; (h) the reference to "para. 646" in paragraph 648(a) of the IAEA Regulations is replaced by "para. 646(a)"; (i) where the English and French versions of the IAEA Regulations each prescribe the use of a word, either the word prescribed by the English version or the word prescribed by the French version may be used; and (j) the phrase "Neither beryllium nor deuterium shall be present in quantities exceeding 0.1% of the fissile material mass" in paragraph 672(a) of the IAEA Regulations is replaced by "Neither beryllium nor deuterium shall be present in quantities exceeding 1% of the applicable consignment mass limits set out in Table XII". (9) Subsections 1(3) and (4) of the Regulations are replaced by the following: (3) For the purposes of these Regulations, paragraph 514 of the IAEA Regulations is replaced by the following: 514. A freight container, tank, intermediate bulk container or conveyance dedicated to the transport of unpackaged radioactive material under exclusive use shall be excepted from the requirements of paragraphs 509 and 513 solely with regard to its internal surfaces and only for as long as it remains under that specific exclusive use. (4) A package shall only qualify as a Type IP-2, Type IP-3, Type A, Type B or Type C package, a package for 0.1 kg or more of uranium hexafluoride, or a package for fissile material, and a radioactive material shall only qualify as a special form radioactive material, low dispersible radioactive material or LSA-III material, if it has been demonstrated that the package or material, as the case may be, meets the applicable performance standards referred to in Section VI of the IAEA Regulations in accordance with paragraphs 701, 702 and 713 to 717 of those Regulations. 4. (1) Subsection 2(1) of the Regulations is replaced by the following: 2. (1) Subject to subsection (2), these Regulations apply in respect of the packaging and transport of nuclear substances, including the design, production, use, inspection, maintenance and repair of packaging and packages and the preparation, consigning, handling, loading, carriage, storage during transport, receipt at final destination and unloading of packages. (2) Paragraph 2(2)(a) of the Regulations is repealed. (3) Paragraph 2(2)(b) of the Regulations is replaced by the following: (b) that is implanted in or incorporated into a person or an animal for medical purposes, or that subsists in the remains of a person; (4) Paragraphs 2(2)(e) and (f) of the Regulations are replaced by the following: (e) that is contained in human or animal tissue or animal remains, or a liquid scintillation medium, where the specific activity of the nuclear substance averaged over the mass of the material does not exceed 10-6 A2/kg; (f) that is contained in consumer products where no licence is required under sections 5 to 8 of the Nuclear Substances and Radiation Devices Regulations, following sale to the end user; (5) Subsection 2(2) of the Regulations is amended by adding the following after paragraph (g): (h) having an activity concentration that does not exceed the values for an exempt material specified in paragraphs 401 to 406 of the IAEA Regulations; (i) in a consignment having a total activity that does not exceed the "activity limit for an exempt consignment" specified in paragraphs 401 to 406 of the IAEA Regulations; or (j) consisting of natural material and ores containing naturally-occurring radionuclides that either are in their natural state, or have been processed only for purposes other than for extraction of those radionuclides, and that is not intended to be processed for use of those radionuclides, provided the activity concentration of the material does not exceed 10 times the "activity concentration for an exempt material" values specified in paragraphs 401 to 406 of the IAEA Regulations. 5. (1) Paragraph 4(b) of the Regulations is replaced by the following: (b) a description of the nuclear substance, including the name, the chemical and physical form, the activity — or in the case of fissile material, the mass — of each nuclear substance in a package and the total quantity of the activity or mass in the consignment; (2) Paragraph 4(j) of the Regulations is replaced by the following: (j) where the nuclear substance is required to be transported in a package of a certified design or in a package that has been approved as Type B(U)-96, Type C-96 or H(U)-96 by a foreign competent authority in accordance with the applicable process specified in the IAEA Regulations, the number of the certificate or approval applicable to the package; (3) Paragraphs 4(m) and (n) of the Regulations are replaced by the following: (m) where a vessel is to be used as a conveyance during transit, the name of the vessel and its flag state; (m.1) for a special use vessel to be used as a conveyance during transit, a document issued by the competent authority of the vessel's flag state approving a radiation protection programme; (n) where the nuclear substance is to be transported by sea, the International Maritime Dangerous Goods Code transport schedule number for the nuclear substance; 6. Paragraph 5(a) of the Regulations is replaced by the following: (a) the information specified in paragraph 825 of the IAEA Regulations; and 7. (1) Paragraphs 6(1)(b) and (c) of the Regulations are replaced by the following: (b) the nuclear substance is 0.1 kg or more of uranium hexafluoride and is transported while in transit; (c) the nuclear substance is required to be transported in a package of a certified design or in a package that has been approved as Type B(U)-96, Type C-96 or H(U)-96 by a foreign competent authority in accordance with the process specified in the IAEA Regulations and is transported while in transit; or (2) Subsection 6(2) of the Regulations is replaced by the following: (2) A person may possess, transfer, import, export, use, abandon, produce or service a package, special form radioactive material or low dispersible radioactive material without a licence to carry on that activity. 8. The heading "CERTIFICATION OF PACKAGES AND SPECIAL FORM RADIOACTIVE MATERIAL" before section 7 of the Regulations is replaced by the following: CERTIFICATION OF PACKAGES, SPECIAL FORM RADIOACTIVE MATERIAL AND LOW DISPERSIBLE RADIOACTIVE MATERIAL 9. (1) The portion of subsection 7(1) of the Regulations before paragraph (b) is replaced by the following: 7. (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act may certify a package design, a design for special form radioactive material or a design for low dispersible radioactive material after receiving an application that includes the following information: (a) the information referred to in paragraphs 803, 805(b), 807, 810 and 813 of the IAEA Regulations, as applicable; (2) Paragraph 7(1)(c) of the Regulations is repealed. (3) Subsection 7(1) of the Regulations is amended by adding the word "and" at the end of paragraph (d) and by adding the following after paragraph (d): (e) at the request of the Commission, any other information that is necessary to enable the Commission to determine if the application for certification meets the requirements of these Regulations. (4) Subsection 7(2) of the Regulations is replaced by the following: (2) An applicant shall give the Commission a reasonable opportunity to observe any test that the applicant conducts to demonstrate compliance of a package design, a design for special form radioactive material or a design for low dispersible radioactive material with these Regulations, including reasonable notice of the date and time of the test. (3) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act may recertify a design certified under subsection (1) if its technical specifications have not changed and the Commission or designated officer receives an application from the certificate holder no later than 60 days after the expiry date of the certificate. The application shall include the following information: (a) a statement confirming that the drawings and procedures previously submitted have not changed or, if they have changed, a copy of the revised drawings and procedures and a statement confirming that the changes are without technical significance and do not affect the safety of the design; (b) a statement confirming that each package has been maintained in compliance with the drawings and procedures previously submitted; (c) in respect of a package design, a statement confirming that the instructions previously submitted have not changed; (d) unless previously submitted, the model number and drawings of any capsule containing radioactive material; (e) in respect of a certified package design, other than one referred to in paragraph (f), a list of the serial numbers of packages manufactured and maintained in accordance with the certified package design; (f) in respect of a certified package design that was certified after approval by a foreign competent authority, a list of the serial numbers of all packages currently in use or intended to be used in Canada; (g) a list of the known users of the latest certified package design; (h) a summary of the maintenance performed and any operational or maintenance problems encountered with the package, including the date, nature of the maintenance or problem and any action taken; (i) in respect of a design originating in a foreign country, a copy of each package design approval document or low dispersible radioactive material approval document issued by the foreign competent authority since the last certification; (j) a copy of the documents submitted to the foreign competent authority in order to obtain a package design approval document referred to in paragraph (i); and (k) at the request of the Commission, any other information that is necessary to enable the Commission to determine if the application meets the applicable requirements of these Regulations. 10. Subsection 8(1) of the Regulations is replaced by the following: 8. (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 package design, a design for special form radioactive material or a design for low dispersible radioactive material of a proposed decision not to certify the design, as well as the basis for the proposed decision, at least 30 days before refusing to certify it. 11. Subsection 9(1) of the Regulations is replaced by the following: 9. (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 package design, a design for special form radioactive material or a design for low dispersible radioactive material 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 the design, as well as the basis for the proposed decision, at least 30 days before decertifying it. 12. The heading "PACKAGES, SPECIAL FORM RADIOACTIVE MATERIAL AND PACKAGING" before section 11 of the Regulations is replaced by the following: PACKAGES, SPECIAL FORM RADIOACTIVE MATERIAL, LOW DISPERSIBLE RADIOACTIVE MATERIAL AND PACKAGING 13. The heading before section 12 of the Regulations is replaced by the following: Production or Possession of Special Form Radioactive Material and Low Dispersible Radioactive Material 14. Section 12 of the Regulations is amended by adding the following after subsection (3): (4) Every person who produces or possesses special form radioactive material approved under the 1973, 1973 (As Amended), 1985 or 1985 (As Amended 1990) Editions of the IAEA Regulations shall act in accordance with paragraph 818 of the IAEA Regulations. (5) No person shall produce low dispersible radioactive material unless (a) it is of a certified design; and (b) it is produced in accordance with the specifications set out in the certificate. (6) Every person who produces low dispersible radioactive material shall identify it by marking it in a legible and durable manner. (7) No person shall possess low dispersible radioactive material unless it is of a certified design. 15. The heading before section 13 of the Regulations is replaced by the following: Quality Assurance Program for Packages, Special Form Radioactive Material and Low Dispersible Radioactive Material 16. (1) The portion of section 13 of the Regulations before paragraph (b) is replaced by the following: 13. Every person who designs, produces, tests, uses, inspects, maintains or repairs a package, special form radioactive material or low dispersible radioactive material shall (a) implement and maintain a written quality assurance program in accordance with paragraph 310 of the IAEA Regulations; (2) Paragraph 13(c) of the Regulations is replaced by the following: (c) retain the record of information collected under the program for the period ending two years after the date on which the package is removed from service. 17. Paragraph 14(2)(e) of the Regulations is repealed. 18. (1) Subsections 15(2) and (3) of the Regulations are replaced by the following: (2) Every consignor, other than a consignor of an excepted package, shall act in accordance with paragraphs 550 to 561 of the IAEA Regulations. (3) Every consignor of an excepted package shall act in accordance with paragraph 554 of the IAEA Regulations. (2) Subsection 15(5) of the Regulations is replaced by the following: (5) Every carrier of radioactive material shall act in accordance with paragraphs 562 to 569 and 571 to 580 of the IAEA Regulations. 19. (1) Paragraphs 16(1)(a) and (b) of the Regulations are replaced by the following: (a) the material is contained in
(ii) a Type IP-1, Type IP-2 or Type IP-3 package, (iii) a Type A package, (iv) a Type B or Type C package of a certified design, (v) a package for fissile material of a certified design, (vi) a package for 0.1 kg or more of uranium hexafluoride of a certified design, (vii) a package whose design is in accordance with the criteria set out in paragraph 815 of the IAEA Regulations and for which package certification is not otherwise required under these Regulations, if the material is packaged in accordance with that paragraph, or (viii) packaging manufactured to a package design certified in accordance with the criteria set out in paragraph 816 or 817 of the IAEA Regulations, where the material is packaged in accordance with those paragraphs; and (b) the activity or mass of the material is within the applicable limits referred to in paragraphs 408 to 415 and 417 to 419 of the IAEA Regulations. (2) Subsection 16(2) of the Regulations is amended by striking out the word "or" at the end of paragraph (a) and by replacing paragraph (b) with the following: (b) a package that is in transit and that 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 applicable process specified in the IAEA Regulations; or (c) a package containing 0.1 kg or more of uranium hexafluoride of a design that has been approved as H(U)-96 by a foreign competent authority in accordance with the applicable process specified in the IAEA Regulations. (3) Subsections 16(3) and (4) of the Regulations are replaced by the following: (3) Subsection (1) does not apply to a consignor who presents for transport, or a carrier who transports, LSA-I material or an SCO-I in accordance with paragraph 523 of the IAEA Regulations. (4) Subject to subsection (5), every consignor and carrier of radioactive material shall act in accordance with paragraphs 501 to 547 of the IAEA Regulations. (4) The portion of subsection 16(5) of the Regulations before paragraph (a) is replaced by the following: (5) A consignor may present for transport, and a carrier may transport, radioactive material in a package that is not labelled in accordance with paragraphs 541 to 543 of the IAEA Regulations, if the package (5) Subparagraph 16(5)(a)(ii) of the Regulations is replaced by the following: (ii) has clearly marked on it the word "RADIOACTIVE" or "RADIOACTIF", the basic trefoil symbol set out in Figure 1 in Section V of the IAEA Regulations and the name, address and telephone number of the person who is authorized by a license to possess the radioactive material that it contains, (6) Paragraph 16(5)(a) of the Regulations is amended by striking out the word "and" at the end of subparagraph (ii), by adding the word "and" at the end of subparagraph (iii) and by adding the following after subparagraph (iii): (iv) is transported by a vehicle that displays on each side and on each end a placard for substances of Class 7 specified in the Transportation of Dangerous Goods Regulations; (7) Paragraph 16(5)(c) of the Regulations is replaced by the following: (c) contains only LSA-I material other than uranium hexafluoride and
(ii) has clearly marked on it the words "RADIOACTIVE LSA-I: EXCLUSIVE USE" or "FAS-I RADIOACTIF : USAGE EXCLUSIF", and (iii) is transported by a vehicle that displays on each side and on each end a placard for substances of Class 7 specified in the Transportation of Dangerous Goods Regulations; or 20. Subsection 17(1) of the Regulations is replaced by the following: 17. (1) Subject to subsection (2), every consignor of radioactive material shall include in the transport documents for the consignment the information referred to in paragraph 549 of the IAEA Regulations which shall be clearly and indelibly printed in the documents. 21. Subsection 19(1) of the Regulations is amended by striking out the word "or" at the end of paragraph (d) and by adding the following after paragraph (e): (f) fissile material is outside the confinement system during transport; or (g) the level of non-fixed contamination during transport exceeds the limits specified in paragraphs 508 and 509 of the IAEA Regulations. 22. (1) The portion of subsection 21(3) of the Regulations before paragraph (a) is replaced by the following: (3) On receipt of a package, and on opening a package, every person shall verify whether (2) Subsection 21(3) of the Regulations is amended by striking out the word "and" at the end of paragraph (b) and by replacing paragraph (c) by the following: (c) any portion of the fissile material is outside the confinement system; and (d) any portion of the contents of the package is outside the containment system or the package. (3) Subsection 21(4) of the Regulations is replaced by the following: (4) Every person who discovers that a package is damaged or that any portion of the fissile material is outside the confinement system shall file a full report of the discovery with the consignor and with the Commission within 21 days after the discovery. 23. The portion of subsection 23(1) of the Regulations before paragraph (a) is replaced by the following: 23. (1) Every person who packages radioactive material in a Type IP-2, Type IP-3 or Type A package shall keep a record of the following information and documents concerning the package: COMING INTO FORCE 24. These Regulations come into force on the day on which they are approved by the Governor in Council. [30-1-o] S.C. 2001, c. 34, s. 61 S.C. 1997, c. 9 SOR/2000-202 SOR/2000-208 |
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