What We Heard Report: DIS-24-01

DIS-24-01, Proposals to Amend the Packaging and Transport of Nuclear Substances Regulations, 2015 and the Nuclear Substances and Radiation Devices Regulations

Preamble

The Canadian Nuclear Safety Commission (CNSC) uses discussion papers, information sessions and workshops to better understand the potential impacts of its proposed regulations, amendments to existing regulations and/or approaches when updating regulatory requirements and guidance.

Introduction

The Nuclear Safety and Control Act (the Act) establishes the CNSC’s authority to set regulatory requirements for all nuclear-related activities in Canada. Under the Act, and as Canada’s nuclear regulator, the CNSC regulates the use of nuclear energy and materials to protect the health, safety and security of Canadians and the environment, to implement Canada’s international commitments with respect to the peaceful use of nuclear energy, and to disseminate objective scientific, technical and regulatory information to the public.

The Nuclear Substances and Radiation Devices Regulations (NSRDR) came into force in 2000, with the last major revision completed in 2008. The NSRDR set out the requirements for the licensing and certification of nuclear substances and radiation devices, the use of radiation devices, and the associated record-keeping.

In addition, the CNSC regulates the packaging and transport of nuclear substances via the Packaging and Transport of Nuclear Substances Regulations, 2015 (PTNSR 2015). While these regulations incorporate by reference the International Atomic Energy Agency’s Regulations for the Safe Transport of Radioactive Material, 2018 Edition (IAEA SSR-6), the PTNSR 2015 have some supplemental regulatory requirements of their own.The PTNSR 2015 came into force on June 12, 2015, and have not been revised since.

These regulations ensure that the health, safety and security of Canadians and of the environment are protected.

Over the past several years, the CNSC has conducted reviews of both regulations and identified several amendments to enhance the clarity of existing requirements and enshrine established and new practices into regulation. DIS-24-01: Proposals to Amend the Packaging and Transport of Nuclear Substances Regulations, 2015 and the Nuclear Substances and Radiation Devices Regulations (DIS-24-01) outlines the results of these reviews.

Consultation process

The CNSC posted a discussion paper (No. DIS-24-01) for public comment from April 2 to June 14, 2024. The goal of the discussion paper was to seek feedback on the proposed amendments to the NSRDR and PTNSR 2015 from the nuclear industry, Indigenous Nations and communities, and other interested parties.

Stakeholders were informed and invited to comment on the discussion paper through various mechanisms, including announcements on the CNSC’s online consultation platform “Let’s Talk Nuclear Safety,” in the “Latest News” and “What’s New” sections of the CNSC website, and in the CNSC’s Directorate of Nuclear Substance Regulation’s Digest. A message was also sent to the CNSC’s email subscription list, alerting recipients that the discussion paper had been posted.

Stakeholder comments were posted on the website “Let’s Talk Nuclear Safety” from April 2 to June 14, 2024, for further comment. A single comment was received during the feedback on comments period from June 17 to July 1, 2024.

Summary of stakeholder comments

Generally, stakeholders expressed support for the proposed changes, while suggesting adjustments in some cases. Some concerns were raised, typically associated with added administrative/regulatory burden on the Canadian industry without any demonstrable risk to the health and safety of Canadians or the environment. The CNSC took these comments into account, and is providing details below.

Impacts were not specified or quantified in the responses received; as such, commenters who identified that there would be impacts on the Canadian nuclear industry and/or their business will be contacted directly for more specific details. Other interested parties should forward any impact data to the CNSC for its consideration.

Other stakeholder suggestions promoted the harmonization of Canadian regulations with international/International Atomic Energy Agency (IAEA) regulatory regimes and guidance, requested greater clarity around terms and new definitions, and proposed removing perceived regulatory duplication.

Moving forward, the CNSC intends to proceed with the proposed changes where there is stakeholder support; further details are provided below. In some cases, the CNSC has reached out to commenters to get clarification and to ensure that amendment decisions will be risk-informed. These discussions are ongoing. Stakeholders will continue to have opportunities to provide feedback throughout the regulation-making process.

The following section summarizes the comments received with respect to the PTNSR 2015 proposed amendments:

Expansion of the list of exempted medical isotopes

Commenters agreed with expanding the list of medical isotopes exempted pursuant to paragraph 2(2)(n) of the PTNSR 2015, and some commenters suggested that other isotopes be included in the list, while others suggested that the exemption be written with a more generic approach.

CNSC response:

The CNSC will consider the proposed isotopes listed by the commenters. Furthermore, the CNSC will consider the possibility of establishing an upper bound limit based on half-life instead of listing specific isotopes at the time of drafting the regulations.

Harmonization with the CNSC’s Radiation Protection Regulations (RPR)

Stakeholders agreed that the PTNSR 2015 should be aligned with the RPR. Some suggested that the requirements not be duplicated in the PTNSR 2015. Other commenters suggested that only requirements applicable to packaging and transport be integrated into the PTNSR 2015. With respect to instrument calibration, stakeholders expressed concerns about the challenges involved with calibrating contamination monitoring instruments.

CNSC response:

The CNSC intends to ensure that the PTNSR 2015 align with the RPR, as well as with any proposed changes to the NSRDR. Commenters should note that, in some cases, duplication of requirements is necessary since requirements set out in the RPR apply to licensees, whereas the requirements in the PTNSR 2015 apply to any person in Canada that transports or presents for transport nuclear substances.

The CNSC agrees with the commenters on the calibration of contamination meters as the concerns are related to the wording used in the discussion paper. In addition, REGDOC-2.7.1, Radiation Protection, provides guidance to support the CNSC’s expectations as to what calibration means for contamination meters. The CNSC will consider updating the requirements in the PTNSR 2015 where necessary, while ensuring alignment with the RPR and the NSRDR.

Requirements regarding low specific activity material

Commenters recommended that the PTNSR 2015 be aligned with the IAEA SSR-6 to facilitate a harmonized transportation regime to allow the safe and efficient worldwide movement of radioactive materials without placing the Canadian industry at a competitive disadvantage.

More specifically, commenters requested that the CNSC align the PTNSR 2015 with the IAEA SSR-6 on the definition of low specific activity (LSA) material and the requirements with respect to the selection of Type IP packages (industrial packages).

Commenters expressed that the current variations in the PTNSR 2015 regarding the classification of LSA material and the selection of Type IP packages have caused difficulties with the movement of radioactive material across borders. They also mentioned that these variations are putting the Canadian companies at a disadvantage due to the additional costs. They highlighted that internationally, there have been no safety issues with the requirements provided in the IAEA SSR-6.

CNSC response:

In light of the information submitted by the commenters regarding these variations from the IAEA SSR‑6, the CNSC will consider revising these variations at the time of drafting the regulations.

Exemptions regarding the transport of naturally occurring nuclear substances (NORM)

For naturally occurring nuclear substances (also referred to as naturally occurring radioactive material or NORM), the PTNSR 2015 provide two options for activity limits that allow for such material to be exempt from the regulatory requirements. Some stakeholders commented that the wording in the PTNSR 2015 pertaining to these limits could be further clarified to state if both limits must be applied (which is not the case) or if only one limit must be applied (which is the case).

Furthermore, some commenters recommended that the PTNSR 2015 be aligned with the more restrictive exemption provided by the IAEA SSR-6.

CNSC response:

The PTNSR 2015 provide two different limits for classifying NORM: the activity concentration limit as set out in the IAEA SSR-6 and the specific activity limit of 70 kBq/kg. The 70 kBq/kg limit is a value that was used in prior versions of the IAEA regulations and that is easily applicable in practice. Furthermore, public safety has not been compromised with shipments characterized based on this limit. However, the CNSC will consider adding language to the PTNSR 2015 to highlight that either one of the two limits can be applied.

Reporting requirements

Commenters were generally supportive of the proposal to remove the annual reporting requirement associated with the detection of unknown nuclear substances during transport. In addition, commenters suggested clarifying that any regulated material (including licensable quantities of material as well as NORM that is subject to the PTNSR 2015) transported without having been properly classified as radioactive material be subject to a reporting requirement.

Commenters expressed concerns that adding reporting requirements associated with the misclassification of nuclear substances to the PTNSR 2015 would represent an unnecessary burden to the industry. Some commenters are of the opinion that greater justification is required for altering the reporting requirements for minor improperly classified material and non-safety/low-safety significant transportation events. Commenters believe that administrative errors or conservatively classified shipments should not be considered as reportable, and that making them so would place an unnecessary administrative burden on licensees without any demonstrable risk to the health and safety of Canadians or the environment.

Some commenters suggested removing the requirements to report transport accidents as well as non-compliances that may adversely affect the health and safety of Canadians or the environment.

CNSC response:

The CNSC takes note of the support expressed by commenters regarding the proposal to remove the annual reporting requirement associated with the detection of unknown nuclear substances during transport. In addition, the CNSC will consider clarifying the reporting requirement associated with regulated quantities of NORM transported without first having been classified as radioactive material.

The CNSC will consider the comments related to the reporting of improperly classified nuclear substances at the time of drafting the regulations.

The CNSC does not, however, intend to remove the requirement to report transport accidents. This requirement ensures that any safety, security, or environmental impacts have been adequately addressed following a transport accident and provides the CNSC with data to identify potential trends.

With respect to the requirement to report non-compliances that may adversely affect the health and safety of Canadians or the environment, the CNSC does not intend to remove this either. The requirement is already articulated in such a way as to preclude situations that do not present a potential impact on health and safety of Canadians or the environment.

Requirement for monitoring equivalent doses to skin, hands and feet

Regarding the proposed amendment to subsection 31(c) of the PTNSR 2015, commenters believe that requiring the monitoring of doses to employees’ extremities and/or skin would be extremely difficult and place an additional regulatory burden on carriers transporting packages.

According to the commenters, it would be difficult for carriers to analyze which employees could receive annual equivalent doses to the extremities and/or skin greater than 50 mSv. This is due to the multiple variables that contribute to the doses, such as the quantities of material handled, activities, and the locations of packages being delivered.

In addition, commenters identified the following factors that would complicate the possible analysis: issuance and compliance monitoring of dosimeters, the number of employees who handle radioactive materials versus those who do not, and employee turnover.

CNSC response:

In consideration of the points made by commenters (summarized above) and the fact that carriers’ employees are unlikely to reach the equivalent dose thresholds to the skin or the hands and feet requiring monitoring with licensed dosimetry, the CNSC does not expect to proceed with this proposed change.

Requirement to obtain a transport licence for conveyances where no person is physically present

Commenters recognized that the transport of nuclear substances in conveyances where no person is physically present, such as remotely piloted aircrafts (drones) or driverless vehicles, may become more prevalent and proposed to consider adding a CNSC notification requirement for this form of transport.

CNSC response:

The CNSC intends to proceed with this proposed change. Given the potential safety and security risks associated with these novel technologies and the fact that the Act does not provide for any notification requirements, adding a transport licence requirement in such cases will ensure that proper controls are in place for these types of transport before they occur.

The following section summarizes the comments received with respect to the NSRDR proposed amendments:

In many cases, general comments were that the proposed changes were welcome and would provide more clarification.

Interpretation and application

New definitions and amendments to existing definitions

As outlined in DIS 24-01, the CNSC intends to update existing definitions and will propose new definitions to enhance clarity of regulations. Several commenters indicated that they needed to see the proposed new wording in order to provide meaningful comments. The CNSC acknowledges these difficulties. The actual wording will be drafted and available for consultation in the Canada Gazette, Part I.

Some commenters were opposed to the proposed change to the definition of a radiation device, as they felt it may impact activities that are currently being performed by licensees. Some commenters indicated that expanding the definition would increase regulatory burden to the industry with no discernable benefit.

In addition, some commenters are seeking greater clarity regarding the inclusion of reporting effluent discharges (both air and water) to the environment and the resulting potential increase in regulatory burden for their operations. As outlined in DIS 24-01, the purpose of this change is to align with existing CNSC practices and the content set out in REGDOC 2.9.1. Environmental Protection: Environmental Principles, Assessments and Protection Measures, and not to increase any regulatory burden for Class I nuclear facilities, uranium mines and/or mills.

CNSC response:

Interested parties will note that the stakeholders will have a chance to provide feedback on the proposed definitions during public consultation in the Canada Gazette, Part I.

As it relates to the proposed change to the definition of a radiation device, the CNSC’s intent is to clarify the existing definition. The CNSC can confirm that there will be no change to the existing practice or increase in regulatory burden.

Regarding the inclusion of reporting effluent discharges, the CNSC can confirm that there will be no additional burden, as the proposed change will simplify an existing CNSC practice and align with the regulatory requirements set out in REGDOC-2.9.1.

Using incorporation by reference

Some commenters recommended that the CNSC use incorporation by reference when referring to any definitions or practices currently published in the Radiation Protection Regulations (RPR) rather than duplicating the contents of the PTNSR 2015 and NSRDR.

CNSC response:

Incorporation by reference will be used when drafting any changes to the PTNSR 2015 and NSRDR. Interested parties should note that a transition period (PTNSR) will be afforded to allow the regulated community time to implement any required changes.

Exemptions from licence requirement

Smoke detectors and tritium safety signs

Commenters indicated that requirements were unclear and that additional information should be included to provide guidance on disposal and to identify any limitations.

CNSC response:

A guidance document will be created to support the amended NSRDR.

General obligations

Leak tests

Several comments were received with respect to the requirement to leak test depleted uranium as shielding when located in an exposure device when the sealed source is also being leak tested.

One comment was received to the effect that it is unclear whether leak testing applies to nuclear substances as shielding with any quantity or only if greater than or equal to 50 MBq, and that there is a potential for misinterpretation.

CNSC response:

Leak testing the sealed source within an exposure device containing depleted uranium shielding is not sufficient to ensure the integrity of the exposure device. The purpose of requesting leak testing of the depleted uranium contained within an exposure device is to verify the integrity of the “S” tube in which the sealed source and Teleflex cable are moving in and out of the exposure device. Over time, the projection and retraction of the sealed source assembly is creating wear in the “S” tube to the extent that the “S” tube wears through, exposing the depleted uranium shielding. A positive leak test for the depleted uranium may imply wearing of the “S” tube that could lead to a source assembly getting stuck and leaving the source capsule in a position that is not fully shielded, or contamination from the depleted uranium on the sealed source assembly and equipment attached to the exposure device, such as the remote control. This is specific to exposure devices. The intent of leak testing the depleted uranium is to prevent a potential incident more so than to verify the integrity of the shielding. If only leak testing of the sealed source is required, a positive leak test of the sealed source could be a false positive that the sealed source is leaking, as it would not be possible to identify the source of the contamination without performing more detailed analysis.

Leak testing of depleted uranium used as shielding for exposure devices is required in all cases; there is no activity limit for shielding, and the limit only applies to sealed sources. It is not expected for licensees to know the activity of the shielding.

Transfers

Commenters sought clarity on the method and time of transferring information, and expressed concern that the specific information to be transferred may possibly be commercially sensitive or proprietary information.

CNSC response:

The CNSC’s intent of the proposed change is for licensees transferring a device to provide all documents that originally came with the device when it was acquired from the manufacturer, such as the user’s manual. The transfer must take place when the device is transferred, and the information can be in any form (email, fax, etc.).

Interested parties should note that this will not impact any commercially sensitive information. As such, the CNSC intends to update the section as planned.

Survey meters – Calibration of measuring instruments

Several commenters expressed concern regarding the requirement for the calibration of contamination meters and direct reading dosimeters (DRDs) used for secondary purposes, and stated that emphasis should be on proper quality control.

Commenters suggested considering efficiencies and routine quality control checks to confirm performance against pre-established standards, as well as efficiency measurements and response checks for performance verification.

CNSC response:

Any dose rate meter used to ascertain dose rates or DRD used to ascertain dose (or potential dose) must be calibrated. The CNSC notes that, as some commenters have suggested, a DRD may not require calibration in accordance with the calibration processes outlined in REGDOC-2.7.1, Radiation Protection, if the DRD is used as a secondary means of confirming that a dose received by a worker is below the regulatory limit when a personal dosimeter is used for the official record of dose.

The CNSC agrees with the commenters on the calibration of contamination meters as the concerns are related to the wording used in the discussion paper. In addition, REGDOC-2.7.1, Radiation Protection, provides guidance to support the CNSC’s expectations as to what calibration means for contamination meters. As outlined in DIS 24-01, the CNSC intends to update Section 20 of NSRDR to align with the requirements in Section 25 of RPR. The CNSC intends to update the section as planned.

Exposure devices

Obligations of operators

The CNSC received comments that the requirement should be maintained as current to keep “work shift.”

CNSC response:

The purpose of the proposed change was to address situations in industry where a worker may work more than one “work shift” within a 24-hour period. The CNSC intends to update the NSRDR to resolve the issue.

Next steps

The CNSC will develop a proposed regulatory amendment package that considers all feedback received. This includes a detailed Regulatory Impact Analysis Statement (RIAS), which is an evidence-based, non-technical synthesis of expected impacts of a proposed regulation. The RIAS and the text of the proposed regulations are expected to be published in the Canada Gazette, Part I, which serves as a tool for further consultation between the Government of Canada and Canadians.

The PTNSR 2015 are currently supported by a regulatory document that provides clarity on how to meet requirements specified in the regulations. The intent is to create a similar regulatory document to support the NSRDR and to update the PTNSR 2015 regulatory document at the same time as the regulations are amended and come into force. Stakeholders will have an opportunity to comment on the proposed changes to the affected REGDOCs during the CNSC’s regular consultation process.

References

1. Nuclear Safety and Control Act (S.C. 1997, c. 9)
2. Nuclear Substances and Radiation Devices Regulations (SOR/2000-207)
3. Packaging and Transport of Nuclear Substances Regulations, 2015(SOR/2015-145)
4. International Atomic Energy Agency’s (IAEA) SSR-6, Regulations for the Safe Transport of Radioactive Material, 2018 Edition 
5. Canadian Nuclear Safety Commission (CNSC), DIS-24-01: Proposals to Amend the Packaging and Transport of Nuclear Substances Regulations, 2015 and the Nuclear Substances and Radiation Devices Regulations, Ottawa, Canada, 2024.
6. CNSC REGDOC 1.6.1: Licence Application Guide: Nuclear Substances and Radiation Devices, Ottawa, Canada, 2017
7. CNSC REGDOC 1.5.1: Application Guide: Certification of Radiation Devices or Class II Prescribed Equipment, Ottawa, Canada, 2020