What We Heard Report – DIS-13-01

Proposals to Amend the Radiation Protection Regulations

Preamble

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.

Introduction

Through the Nuclear Safety and Control Act and its regulations, the Canadian Nuclear Safety Commission (CNSC) regulates all nuclear activities in Canada in order to protect the health and safety of workers and the public from ionizing radiation.

The Radiation Protection Regulations (RPR) play an important role in achieving this goal by placing limits on radiation doses to workers and members of the public, and by requiring all CNSC licensees to implement radiation protection programs.

Recently, the CNSC recognized the need to review the RPR in light of various developments since they were introduced in the year 2000, including:

1. Changes to international benchmarks:
   In 2007, the International Commission on Radiological Protection (ICRP) published a revised set of recommendations for its system of radiological protection. These recommendations were published in ICRP Publication 103 (ICRP 103), which incorporates updates based on more recent scientific information as well as new guidance on controlling radiation exposure. The current RPR are largely based on ICRP Publication 60 (ICRP 60), which was published in 1990.
   In 2006, the International Atomic Energy Agency (IAEA) undertook a review and initiated a revision of the 1996 edition of its Basic Safety Standards, in cooperation with other organizations. The IAEA published the revised standards in 2014, incorporating the ICRP 103 recommendations and other safety-related improvements.
2. The March 2011 nuclear event in Fukushima, Japan:
   The nuclear event in Fukushima prompted the CNSC to examine its regulatory framework and identify how to strengthen it, particularly with respect to nuclear emergencies. The CNSC determined that the RPR needed to more fully describe requirements for addressing radiological hazards during an emergency, and has therefore proposed amendments to section 15.
3. Lessons learned:
   Since the RPR came into force in May 2000, the CNSC has benefitted from 15 years of regulatory experience. This has enabled it to identify opportunities to improve the Regulations by addressing specific gaps and providing additional clarity.

DIS-13-01, Proposals to Amend the Radiation Protection Regulations describes the CNSC's proposals to amend the RPR. These amendments would harmonize them with updated ICRP and IAEA guidance, where appropriate. The amendments would also clarify requirements and address gaps that were identified post-Fukushima, as well as through lessons learned over time.

Consultation process

The CNSC published DIS-13-01 for public comment on August 9, 2013 for a 120-day period. The discussion paper sought input from stakeholders and the public. The CNSC posted an invitation to comment on the discussion paper on its website, as well as a similar notification on its Facebook page, and forwarded an information bulletin to its stakeholders. The consultation notice was also posted on the Government of Canada’s Consulting with Canadians website.

On January 27, 2014, the CNSC posted the comments it received on its website, and issued an invitation to provide feedback for a four-week period. The CNSC received 42 submissions, totaling over 400 comments from stakeholders, over the course of both comment periods.

CNSC staff also participated in various outreach sessions in 2014 to further communicate its intention to revise the RPR and to engage stakeholders.

Summary of stakeholder comments

Overall, there is broad support for many of the proposals to modernize the RPR. Stakeholders supported clarifying the CNSC’s regulatory expectations, updating terminology, and reducing regulatory burden.

In contrast, stakeholders expressed concern with some of the proposals, questioning the benefit of the amendment given the potential administrative and financial burden imposed by the change. There were also suggestions that requirements could be clarified through the CNSC’s regulatory documents rather than through regulations.

Moving forward, the CNSC plans to proceed with many of the regulatory amendments where there is stakeholder support. Stakeholders will continue to have opportunities to provide feedback through the regulation making process.

The following is a summary by section of the comments received from stakeholders.

Section 1: Definitions and Section 2: Application

Stakeholders generally supported new or revised definitions to clarify regulatory requirements. Stakeholders noted that the proposed definition of the term “caregiver” did not take into account persons inside of a medical facility providing care and comfort to a loved one. The CNSC recognizes the need to consider caregivers within a medical facility and will amend the proposed definition accordingly.   

Section 3: Administration of Nuclear Substance for Medical Purposes

Stakeholders identified logistical issues and an administrative burden with informing all possible caregivers of their potential exposures.

Recognizing the points of concern raised by stakeholders, and that not all potential caregivers are known in advance or can change without notice, the CNSC does not intend to amend the regulations. It will instead determine the best approach to ensure patients and caregivers have adequate information, including introducing guidance in future regulatory documents.

Section 4: Radiation Protection Program

Stakeholders supported simplifying the text by removing the reference to radon progeny while preserving the section’s intent. There was also general support of CNSC’s position that introducing a requirement for dose constraints is unnecessary at this time, with many respondents making reference to robust ALARA programs that are in place in the nuclear industry.

Section 5: Ascertainment and Recording of Doses

Stakeholders were concerned with the removal of the references to radon progeny exposure in section 5, stating that in this case, it is not a simplification of wording but rather represents a change from recording exposure to radon progeny to recording a dose.

Given the feedback received, the CNSC will maintain the reference to radon progeny in this section of the regulations.

Section 7: Provision of Information to All Workers

The vast majority of stakeholders were concerned with the proposal to expand section 7 such that licensees would be required to provide information to all workers, with claims of significant financial and administrative burden, with little apparent benefit from a risk perspective.

Given the very strong opposition to the proposal, amendments to the regulations will not be undertaken. However, the CNSC considers that providing risk information to all workers is important and plans to document regulatory expectations for this area in a future regulatory document.

Section 7: Provision of Dose Information

Stakeholders requested clarification of the acceptable methods for informing workers of their dose information. The CNSC intends on clarifying the required timeframe for reporting dose levels to workers in regulations, and may incorporate supporting details into regulatory documents.

Section 7: Provision of Information Related to Emergencies

Stakeholders identified some challenges with the proposed requirement to inform all persons of their duties and responsibilities with respect to emergencies and requested clarification of the term “emergency” in relation to their licensed activity.

The points of concern and the matters of clarification raised by stakeholders will be considered in the drafting of the regulatory text, with further guidance detailed in future regulatory documents.

Section 7 and 11: Requirements Related to Breastfeeding

The CNSC proposed new requirements for protecting breast-fed infants, to align with international best practices and to enhance the protection of all persons. Stakeholders expressed concern with the proposed new requirements, noting possible privacy issues. Certain stakeholders also felt that the requirement would constitute a burden since there was no potential risk to female workers in their particular workplace(s). Lastly, most stakeholders recommended that any new requirements should only apply to female nuclear energy workers.

Taking into consideration the comments received and the objective of enhancing protection, the CNSC plans to introduce the requirements related to breastfeeding into regulation for female nuclear energy workers, as opposed to all female workers as originally proposed.

Section 8: Requirement to Use Licensed Dosimetry Service – Equivalent Doses

There was general agreement of the proposed change, with stakeholders indicating that requiring licensees to use a licensed dosimetry service for the ascertainment of equivalent doses to the skin or the skin of the hands and feet if there is a reasonable probability of receiving a dose greater than 50 mSv/year would formalize existing practice.

Section 13: Formulas for Calculating Effective Dose

Approximately half of those commenting on this section did not support removing the mathematical formulae from the regulations. The remaining stakeholders were supportive, provided that accompanying regulatory guidance material would be made available to licensees.

The CNSC plans to proceed with this amendment to simplify the regulations, while providing detailed information on the appropriate methods for calculating effective doses in future regulatory documents.

Section 13: Definition of the Five-Year Dosimetry Period

Stakeholders indicated that any amendment to how the five-year dosimetry period is defined would cause an unnecessary change to existing programs without a commensurate benefit to safety.

Given the feedback received, the CNSC is not planning to proceed with an amendment to the definition of the five-year dosimetry period.

Section 14: Equivalent Dose Limits – Clarification for Hands and Feet

Stakeholders supported clarifying the term “hands and feet” to read “the skin of each hand and foot” to more accurately reflect the actual measurement of equivalent dose to the hands and feet, as well as the intent of the dose limit. As such, the wording will be changed in the regulations.

Section 14: Equivalent Dose Limits – Equivalent Dose Limits for the Lens of an Eye

The vast majority of stakeholders identified the proposed change to the dose limit for the lens of an eye as a critical issue. Stakeholder concerns included:

• technical issues with the determination of dose to the lens of an eye, including the current lack of CNSC-licensed dosimetry for measuring such doses
• challenging the appropriateness of the new dose limit based on a review of the scientific evidence of health effects; many believed that more research needs to be undertaken before dose limits are changed
• claims that the change in the dose limit is not warranted, considering that the health effect (cataracts) are regarded as easily treatable
• significant financial and administrative burden with the proposed change and the associated impact on their operation: in particular for those exposure situations with non-uniform fields where the lens of an eye dose could be the limiting exposure for workers

Given the feedback received and the objective of enhancing protection to workers, the CNSC plans to proceed with this amendment. However, it is recognized that there is a need for additional communication with stakeholders and licensees on the planned path forward to amend the dose limit for the lens of an eye in regulations. The CNSC is planning to provide further information to licensees, including background information on the basis for the proposed change, recommendations on how to ascertain the dose to the lens of an eye, and the methods for dose optimization.

Section 15: Emergencies

Stakeholders generally supported the proposed changes to the section on emergencies, although many licensees recommended that terminology used in section 15 align with what is used internationally and that the CNSC develop accompanying guidance to ensure regulatory expectations are clear.

Given the feedback received, and considering the lessons learned from the Fukushima event in 2011, the CNSC plans to proceed with revisions to section 15 to clarify requirements regarding dose limits and their application during different phases of an emergency. This will align the regulations with current international standards and guidance, and assist in continuing to ensure the health, safety and security of Canadians and the environment.

Section 16: When Dose Limit Exceeded

Stakeholders generally supported the proposal to change this section, such that licensees would only require a person to leave any work that is likely to add to their dose, if the person may have or has exceeded any of the dose limits that apply to nuclear energy workers.

Section 17: Authorization of Return to Work

Stakeholders supported the proposed amendment, which will allow for flexibility in the determination of prorated dose limits for the purposes of authorizing the return to work of a person who exceeds a dose limit.

Section 18: Application for Licence to Operate

In general, stakeholders indicated there would be no benefit in incorporating certain requirements currently found in CNSC regulatory standard S-106, Technical and Quality Assurance Requirements for Dosimetry Services into section 18.

Given the feedback received, the CNSC plans to limit the scope of the amendments to those of clarification.

Section 19: Obligations of Licensees

Stakeholders generally supported the proposed changes to improve reporting of doses measured by licensed dosimetry services to the National Dose Registry.

Section 20: Labelling of Containers and Devices

Stakeholders supported the proposed addition of a requirement to subsection 20 (2) to exempt radium luminous devices from labelling requirements provided that radium is the only nuclear substance in the device and the device is not disassembled or tampered with. This new requirement will ensure that persons who own radium luminous devices which meet the terms of the indefinite exemption to paragraph 8(b) of the Nuclear Substances and Radiation Devices Regulations are not subject to the current labelling requirements.

Section 20: Labelling of Waste Containers

While DIS-13-01 proposed no amendments to the requirement for labelling waste containers, a number of stakeholders suggested that clarity is needed with respect to its application. Commenters noted that waste in active containers (those in use) continuously accumulates, and it is logistically difficult to label waste containers with all required information as prescribed by the regulations.

The concerns expressed by stakeholders have merit and will be explored further by the CNSC during the regulatory amendment process.

Section 21: Posting of Signs at Boundaries and Points of Access

Stakeholders supported the proposal to amend this section to clarify requirements for posting signs on vehicles used for storage, and not consigned for transport.

Section 24: Records to be Kept by Licensees

Stakeholders did not support the proposal to adopt the IAEA retention period for dose records.

The CNSC concludes that the proposal to add a specific retention period for exposure records is important and plans to take into account national and international benchmarks when determining the appropriate retention period for this type of record.

Schedule 1: Weighting Factors and Schedule 2: Radiation Weighting Factors

Stakeholders supported removing two schedules from regulations to facilitate future changes. The CNSC will explore the possibility of introducing the relevant information in future regulatory documents.

New sections proposed for the Radiation Protection Regulations

Proposed section on radiation detection and measurement instrumentation

While there was general support for consolidating all requirements related to instruments in the regulations, many stakeholders were of the view that reference to specific standards should not be included in regulation. The CNSC plans to proceed with a new section in the regulations related to radiation instrumentation while taking into consideration the comments received.

Proposed section on responsibility for radiation protection

Stakeholders expressed concern that this requirement would prevent licensees from having control over their organizational structure. Some stakeholders stated that this requirement already exists for many licensees. Questions were also raised on what would be expected of the individual appointed to this role in terms of training and education.

Given the feedback received, the CNSC is not planning to proceed with this proposed new section in the regulations but does plan to address this topic in a future regulatory document.

Carriers of nuclear substances

Stakeholders expressed the view that any radiation protection related requirements for carriers should remain in the Packaging and Transport of Nuclear Substances Regulations.

The latest revision of the Packaging and Transport of Nuclear Substances Regulations, 2015 has incorporated radiation safety requirements for the protection of carriers. Therefore, the CNSC will not be proceeding with amendments to the Radiation Protection Regulations in this area.

Next steps

The CNSC plans to move forward with some of the proposed amendments to harmonize the RPR with updated international requirements and guidance and to address gaps identified post-Fukushima.
Feedback received on DIS-13-01 has contributed to an enhanced understanding of stakeholder needs as the CNSC plans updates to its regulatory documents in the areas of radiation protection and dosimetry.

DIS-13-01 is the first step in the public consultation process for the CNSC’s revisions to the RPR. Stakeholders will have further opportunities to comment on any proposed amendments when they are published in Canada Gazette, Part I.