What We Heard Report – DIS-16-02
DIS-16-02, Radiation Protection and Dosimetry
Discussion papers play an important role in the selection and development of the regulatory framework and regulatory program of the Canadian Nuclear Safety Commission (CNSC). They are used to solicit early feedback on CNSC policies or approaches.
The use of discussion papers early in the regulatory process underlines the CNSC’s commitment to a transparent consultation process. The CNSC analyzes and considers preliminary feedback when determining the type and nature of requirements and guidance to issue.
This discussion paper was used to seek feedback on the proposal to create two new regulatory documents that will provide CNSC guidance for radiation protection and dosimetry. The new documents will supersede existing CNSC regulatory documentation, ensure that guidance is aligned with the Radiation Protection Regulations, and provide consolidated guidance on dosimetry and on radiation protection.
The CNSC published DIS-16-02 for public comment on April 29, 2016 for an initial 60-day period. At the request of stakeholders, the consultation period was extended by 60 days (for a total of 120 days) until September 26, 2016. To improve their written submissions, a few stakeholders requested a meeting with CNSC staff to clarify some aspects of the discussion paper and the CNSC’s intention to consolidate multiple regulatory documents. The CNSC therefore held an information session on September 15, 2016, and participants were invited to submit their feedback via the official consultation channels.
Comments were received from 12 organizations and individuals, and were posted on the CNSC website for feedback between October 20 and November 10, 2016.
Summary of stakeholder comments
A wide variety of comments were received. Comments expressed concern regarding the potential for increased burden on licensees as a result of the proposed new regulatory documents. Many comments highlighted areas where more guidance and clarification may be beneficial.
Comments fell into five general themes. Each theme is discussed below and accompanied by an indication of how the CNSC plans to address feedback received. Early information on the two new regulatory documents that will provide CNSC guidance on radiation protection and dosimetry will be provided when possible.
Theme 1: Consolidation of information and administrative burden related to simultaneous projects
Summary of comments
Licensees commented that the creation of the proposed two new regulatory documents may result in a resource burden because of the difficultly to provide the needed resources to properly assess the documents’ large scope in a timely manner. However, it was noted that the burden could not be determined due to the breadth of the proposals. Commenters indicated that they will be able to assess the impact of potential changes more accurately once the draft regulatory documents are made available for a comment period. Commenters were concerned that some changes may require licence amendments and significant resource commitments, without improving safety or quality. In addition, some commenters requested a sufficiently long implementation period to allow them to make all the necessary changes to their documentations so that it may be aligned with the new REGDOCs.
Commenters also voiced concerns that they were unable to fully assess the potential impact of the proposed new regulatory documents because the revised Radiation Protection Regulations have not been published. Specifically, amendments made to the regulations will determine the appropriate scope for guidance in the new regulatory documents.
Over the past several years, CNSC staff have been progressing on a broad review of the CNSC’s regulatory framework. This has focused on building a more modern framework to continue to ensure that licensees and applicants clearly understand the CNSC’s regulatory expectations. A key objective is to ensure that CNSC’s regulatory requirements are up to date, well defined and supported by guidance where necessary, and able to address new and emerging technologies.
In pursuing this objective, the CNSC has organized its catalogue of existing and planned regulatory documents under three categories: regulated facilities and activities; safety and control areas; and other regulatory areas. The modernization initiative’s goal is to consolidate and reduce the more than 150 previously published regulatory documents, including 12 related to radiation protection and dosimetry, into 58 regulatory documents, to be published by 2018.
The proposed two regulatory documents outlined in DIS-16-02 would contain guidance on complying with requirements in the Radiation Protection Regulations. The proposed new regulatory documents on radiation protection and dosimetry will apply to every CNSC licensee as the Radiation Protection Regulations must be adhered to by all CNSC licensees. The graded approach will be used. Requirements will be commensurate with the complexity and relative risk of the licensed activity/facility.
Stakeholder engagement will continue to be a cornerstone of the regulatory framework program, be it through early consultation via discussion papers, outreach activities or formal public consultations. For example, drafts of REGDOC-2.7.1, Radiation Protection, and REGDOC 2.7.2, Dosimetry, will be posted for comment in 2017.
Theme 2: Ascertaining dose to the lens of the eye
Summary of comments
Respondents commented that it is too soon for the Canadian industry to implement the proposed new dose limits for the lens of the eye as recommended by the International Commission on Radiological Protection. Issues raised included unavailability of instrumentation to measure dose to the lens of the eye with the necessary accuracy or precision. Further, licensees expressed concern with incurring substantial costs to measure and control doses to the lens of the eye compared to other potential safety improvements.
The comments on the proposed new dose limits for the lens of the eye are out of the scope of the CNSC’s initiative to consolidate guidance on dosimetry and radiation protection in two new regulatory documents. It should be noted that similar comments have been expressed and taken into consideration as part of the regulation process for the amendments to the Radiation Protection Regulations. The CNSC is committed to working with stakeholders, in the context of the future regulatory documents, to ensure that licensees have the necessary technical information to assist them in ascertaining doses to the lens of the eye and keeping exposures as low as reasonably achievable.The intention is that most of the information found in the CNSC’s Technical Note: Proposed Changes to the Equivalent Dose Limit for Lens of the Eye will be incorporated into the new regulatory documents as guidance. All attempts will be made to clarify issues that have been raised since the publication of the technical note, including concerns raised regarding estimations and computations versus direct measurements.
Theme 3: Licensing and compliance of dosimetry services
Summary of comments
Industry expressed concern with incorporating S-106, Rev. 1, Technical and Quality Assurance Requirements for Dosimetry Services, into a larger regulatory document. S-106 provides the basis for developing an effective quality assurance program that ensures dosimetry results are accurate, repeatable, verifiable, and properly recorded. Stakeholders were concerned that including this content in the dosimetry regulatory document would impact the dosimetry licensing process and lead to potential confusion between guidance information and requirements.
The CNSC agrees with comments regarding the importance of clearly communicating and differentiating guidance information from regulatory requirements. As such, it intends to have a separate part dedicated to the contents of the S-106 Rev. 1, Technical and Quality Assurance Requirements for Dosimetry Services. REGDOC 2.7.2 Part II, that will specifically apply to licensed dosimetry services, would be presented in a stand-alone part of the dosimetry regulatory document. Consequently, dosimetry service licensees will have to comply with this specific part (REGDOC 2.7.2 Part II) of the regulatory document. The remaining part of the document would include consolidated guidance on dosimetry.
Theme 4: Flexibility of requirements and guidance
Summary of comments
Many comments expressed concern that the proposed new regulatory documents could introduce a number of unnecessarily prescriptive practices that are not needed and not tied directly to implementing the Radiation Protection Regulations. Commenters also indicated that there needs to be some flexibility on reasonableness with regard to use of the guidance contained in the regulatory documents.
In addition, commenters expressed concerns that the introduction of guidance for dose constraints could lead to a significant administrative burden without significant value added.
REGDOC-2.7.1 on radiation protection will provide guidance to support the effective implementation of the Radiation Protection Regulations, including any proposed amendments currently under consideration. No new requirements will be introduced in the new regulatory document. Some concepts related to the principles of radiation protection may be included, but only at a high level to illustrate and/or provide guidance in complying with the corresponding regulatory requirements.
The CNSC confirms that the concept of dose constraints will not be introduced in the regulations. The integration of existing regulatory guidance on the application of the ‘as low as reasonably achievable’ (ALARA) principle will be included in the new regulatory documents. This guidance will be updated and will include recommendations for the use of dose constraints as a tool that licensees may incorporate into their ALARA programs.
Theme 5: Codification of current best practices (concerns with new guidance and new concepts)
Summary of comments
Stakeholders asked for clarification on what is meant by "current best practices"; specifically, the development of meaningful action levels and how CNSC staff will determine best practices. Some commenters also recommended replacing the concept of ALARA with the requirement to protect people against exposures that exceed thresholds for harm.
CNSC staff will develop guidance based on regulatory experience gained since the coming into force of the Radiation Protection Regulations in 2000. The proposed new regulatory documents will also contain guidance on the proposed new requirements for Radiation Protection Regulations. The CNSC encourages licensees to develop new and innovative approaches to enhance the radiation safety of workers.
The ALARA principle is a cornerstone of the CNSC’s radiation protection framework and will remain in regulation and supporting guidance.
As noted by the commenters, guidance for developing meaningful action levels is provided in the current CNSC document G-228, Developing and Using Action Levels. CNSC staff will incorporate current guidance on action levels and any clarifications based on regulatory experience in the proposed regulatory document.
At this time, it is the CNSC's intention to draft regulatory documents that will supersede existing CNSC regulatory documentation, ensure guidance is aligned with the Radiation Protection Regulations, and provide consolidated guidance on dosimetry and on radiation protection. The CNSC intends to have more in-depth consultation with stakeholders once a draft is developed. The CNSC is always looking for ways to improve its regulations and welcomes feedback at any time.
Canadian Nuclear Safety Commission
P.O. Box 1046, Station B
280 Slater Street
Ottawa, ON K1P 5S9
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