Discussion Paper DIS-22-01, Proposal to Amend the Class II Nuclear Facilities and Prescribed Equipment Regulations

Consultation has concluded

The Canadian Nuclear Safety Commission (CNSC) has identified considerations for a potential revision of the Class II Nuclear Facilities and Prescribed Equipment Regulations (C2NFPER). If revised, the new version would supersede the existing C2NFPER, dated 2000 (last substantially amended in May 2010). This discussion paper is being issued to provide information and solicit feedback on these considerations.

The CNSC was mindful of the following goals while performing this regulatory review:

  • Modernize the C2NFPER to reflect the latest technological changes, and where possible, strive to create technology-neutral regulations.
  • Incorporate the operational experience gained since the last regulatory review in performing licensing and compliance verification activities involving Class II prescribed equipment.
  • Allow for flexibility while still ensuring safety.
  • Reduce regulatory burden through streamlining and removal of duplicate requirements, where they exist.
  • Ensure that the C2NFPER are logical and align with existing good practices, where they exist.
  • Make the C2NFPER easier to understand and use for all stakeholders.

In addition to the general need to harmonize and modernize the C2NFPER in light of the evolution of the CNSC's regulatory framework over the past 20 years, several specific considerations for changes are outlined. These considerations include:

  • regulation of all particle accelerators (including high-energy accelerators currently regulated as Class IB facilities) under the Class II regime
  • regulation of Class II prescribed equipment that is intended to be operated outside a shielded facility, and clarification of the term “Class II nuclear facility” as it pertains to the C2NFPER
  • introduction of a two-stream approach to licensing in order to allow for different licensing approaches between mass-produced standard Class II equipment/facilities and unique non-standard Class II equipment/facilities
  • a shift towards generic, outcome-based radiation protection safety system requirements, with guidance on how these requirements should be implemented contained in an associated regulatory document
  • introduction of provisions allowing for the amendment and expiry of certificates issued to Class II radiation safety officers (RSOs), and for the recertification of RSOs
  • changes to the activities that may be carried out without a CNSC licence, and changes to existing exemptions from equipment and personnel (RSO) certification
  • ease-of-use changes to many sections of the C2NFPER, such as re-ordering and grouping to better reflect how these sections are actually used by stakeholders (in particular those sections that detail the information to be submitted to the CNSC in support of a licence or certificate application)

The purpose of this discussion paper is to gather feedback from licensees, proponents, the Canadian public, Indigenous peoples, and other stakeholders on these considerations. All feedback received during this consultation will inform the CNSC’s approach in moving forward with these regulatory considerations for potential amendments. Once this preliminary consultation is complete, the CNSC will finalize its analysis. Stakeholders will have further opportunity to comment on a more formal proposal for the changes being considered during the Canada Gazette, Part I, pre-publication process.

We would appreciate stakeholders’ special attention to any potential impacts on their operating and administrative costs that the considerations for potential changes discussed in this document may have. The CNSC will proceed with a cost–benefit analysis (CBA) when this preliminary consultation is completed and its findings analyzed*.


*A CBA is a structured approach to identifying and considering the economic, environmental and social effects of a regulatory proposal. The CBA identifies and measures the positive and negative impact of regulatory proposals so that decision makers can determine the best course of action.

The Canadian Nuclear Safety Commission (CNSC) has identified considerations for a potential revision of the Class II Nuclear Facilities and Prescribed Equipment Regulations (C2NFPER). If revised, the new version would supersede the existing C2NFPER, dated 2000 (last substantially amended in May 2010). This discussion paper is being issued to provide information and solicit feedback on these considerations.

The CNSC was mindful of the following goals while performing this regulatory review:

  • Modernize the C2NFPER to reflect the latest technological changes, and where possible, strive to create technology-neutral regulations.
  • Incorporate the operational experience gained since the last regulatory review in performing licensing and compliance verification activities involving Class II prescribed equipment.
  • Allow for flexibility while still ensuring safety.
  • Reduce regulatory burden through streamlining and removal of duplicate requirements, where they exist.
  • Ensure that the C2NFPER are logical and align with existing good practices, where they exist.
  • Make the C2NFPER easier to understand and use for all stakeholders.

In addition to the general need to harmonize and modernize the C2NFPER in light of the evolution of the CNSC's regulatory framework over the past 20 years, several specific considerations for changes are outlined. These considerations include:

  • regulation of all particle accelerators (including high-energy accelerators currently regulated as Class IB facilities) under the Class II regime
  • regulation of Class II prescribed equipment that is intended to be operated outside a shielded facility, and clarification of the term “Class II nuclear facility” as it pertains to the C2NFPER
  • introduction of a two-stream approach to licensing in order to allow for different licensing approaches between mass-produced standard Class II equipment/facilities and unique non-standard Class II equipment/facilities
  • a shift towards generic, outcome-based radiation protection safety system requirements, with guidance on how these requirements should be implemented contained in an associated regulatory document
  • introduction of provisions allowing for the amendment and expiry of certificates issued to Class II radiation safety officers (RSOs), and for the recertification of RSOs
  • changes to the activities that may be carried out without a CNSC licence, and changes to existing exemptions from equipment and personnel (RSO) certification
  • ease-of-use changes to many sections of the C2NFPER, such as re-ordering and grouping to better reflect how these sections are actually used by stakeholders (in particular those sections that detail the information to be submitted to the CNSC in support of a licence or certificate application)

The purpose of this discussion paper is to gather feedback from licensees, proponents, the Canadian public, Indigenous peoples, and other stakeholders on these considerations. All feedback received during this consultation will inform the CNSC’s approach in moving forward with these regulatory considerations for potential amendments. Once this preliminary consultation is complete, the CNSC will finalize its analysis. Stakeholders will have further opportunity to comment on a more formal proposal for the changes being considered during the Canada Gazette, Part I, pre-publication process.

We would appreciate stakeholders’ special attention to any potential impacts on their operating and administrative costs that the considerations for potential changes discussed in this document may have. The CNSC will proceed with a cost–benefit analysis (CBA) when this preliminary consultation is completed and its findings analyzed*.


*A CBA is a structured approach to identifying and considering the economic, environmental and social effects of a regulatory proposal. The CBA identifies and measures the positive and negative impact of regulatory proposals so that decision makers can determine the best course of action.

Consultation has concluded

  • Comments on comments received

    We have received the following comments on comments:

    Please note, comments are posted in the language in which they are received.


    Commenter
    		 Document section / reference
    		 Comment
    Jeff Dovyak RTNM, CRPA (R)
    Radiation Safety Coordinator
    Shared Health Manitoba

    		 4.2.4.1

    		 Proposed change: Ensure decommissioning activities are performed only by (or under the supervision of) persons or entities who hold a valid CNSC servicing licence.

    It is gratifying to see that I am not the only Radiation Safety professional who opposes this proposed amendment. The points raised by Ms Franz, Ms Frattinger and Mr Beniston as well as McMaster University and Mr Arnaldo with Ontario Tech University (OUT) particularly resonate with me
    Jeff Dovyak RTNM, CRPA (R)
    Radiation Safety Coordinator
    Shared Health Manitoba
    		 4.5.2.1

    Proposed change: Add a provision under which certificates issued to Class II
    radiation safety officers will expire after a certain period, to be defined by the CNSC.


    Consequently, a clause that will require periodic recertification of a Class II RSO will also be added.
    Again I’m glad to see that I’m not the only one who opposes this proposed amendment.


    Comments from Dr Galea, Mr Hardy, Ms Franz, Ms Hargraves, Ms Frattinger, Ms
    Dombrosky and Mr Beniston as well as McMaster University, University Health Network and Mr Arnaldo with OTU again resonate with me.

    I should also say Dr Buckley’s comments here regarding ‘renewal’ vs ‘re-certification’ are well thought out.









  • Comments received

    We have received the following comments:

    Please note, comments are posted in the language in which they are received.

    Commenter Document section/ reference Comment

    Dr. Raphael Galea

    RES Team Lead / Metrology Research Centre / National Research Council Canada / Government of Canada

    Chef d’équipe RES / Centre de recherche en métrologie / Conseil national de recherche Canada / Gouvernement du Canada


    		 4.5.2.1

    While I can see the appeal to the proposed change 4.5.2.1, and perhaps my feelings on this are highly dependent on the period which is being considered for recertification (1, 3, 5, 10 years?), I do object to this proposed change. An RSO need not be the individual operating the Class II equipment and hence the burden is placed more on someone giving oversight to safety rather than the safe operation of the equipment by the individuals. The RSO should ensure that proper training in the safe operation of the Class II equipment is performed for certified users and new users but may not need the training themselves. Will the inspection and auditing burden be reduced due to this re-certification? I imagine this will not as the inspections will always need to be performed by the CNSC. Perhaps as the result of failures or non-conformances that result from an audit a particular RSO can be required to recertify, but if inspections indicate that the operation of the Class II equipment is running without incident or issue, then this is simply regulatory burden that adds nothing to the radiation protection program. By admission the change adds regulatory burden but also burden upon the RSO to maintain their certification which may seem insignificant but for the most part RSO duties are often add on responsibilities to the individual accepting this position.

    Proposed change: Add a provision under which certificates issued to Class II radiation safety officers will expire after a certain period, to be defined by the CNSC. Consequently, a clause that will require periodic recertification of a Class II RSO will also be added.

    I would PREFER NO recertification for those licensees which are performing well audit after audit. That is an indication that the RSO is performing their duty. If that is ultimately decided to do so then something at minimum would be a 10 years cycle or LONGER. If certification is to take place then a minimum burden like a short quiz would be preferable for that certification.

    Perhaps the ideal situation is to have a dynamic recertification policy. No recertification if nothing significant changes or there are no issues during audits. Certification for new RSOs. Certification over a period of 10 years or dynamically to be determined following a justification after an inspection.

    Brandon Hardy

    Nova Scotia Health Authority


    		 Section 4.4 A self-shielded Class II device (cyclotron) should be exempt from this proposed regulation as entry into vaults that are self-shielded is deemed safe via annual surveys.

    Brandon Hardy

    Nova Scotia Health Authority


    		 Section 4.5 The regulator should provide more information on the frequency of these proposed certification renewal requirements. Our organization does not believe this change to be necessary as all Class II certified RSOs are well informed of regulation and policy.
    Jeff Dovyak
    Shared Health
    Mannitoba    		 4.2.4.1

    I am opposed to this proposal. I think that this could be an undue expense to licensees - licensees are qualified to supervise decommissioning of their own facilities. Another consideration is the availability, or lack of availability, of someone with a CNSC servicing licence when a licensee is prepared to begin decommissioning.

    Proposed change: Ensure decommissioning activities are performed only by (or under the supervision of) persons or entities who hold a valid CNSC servicing licence.
    Jeff Dovyak
    Shared Health
    Mannitoba    		 4.5.2.1

    I am opposed to this proposal. I think that Class II RSOs who are continuously employed as Class II RSOs should only have to show evidence of relevant continuing education, not undergo recertification (my fear is that to CNSC recertification means another exam). This could be similar to maintenance of registration that the Canadian Radiation Protection Association (CRPA) requires of those with the CRPA (R) credential, or the review of evidence of clinical practice and appropriate continuing education as practiced by the Canadian College of Physicists in Medicine (CCPM). If this proposal is adopted presumably there will be dialog with the regulated community on agreement of what the CNSC considers is relevant or appropriate continuing education.

    Proposed change: Add a provision under which certificates issued to Class II radiation safety officers will expire after a certain period, to be defined by the CNSC. Consequently, a clause that will require periodic recertification of a Class II RSO will also be added.
    Elekta


    		 4.2.3.3 As a manufacturer of Class II equipment (Elekta), we would like to provide input related to the frequency or circumstance for testing power mains as an EPO. Full power down is very hard on treatment units and following this, there is a very good chance that the unit will not then be operable after. Our recommendation is that power mains are only tested during assigned service days, by FSE-giving them time to trouble shoot, if needed.
    Elekta 4.2.5.1 We (Elekta) agree!
    Elekta 4.3.1

    		 We (Elekta) feel that class II equipment that we previously certified for clinical use should be exempt from re-certification once past its end of life. Any facility that then continues to need/use the equipment should then be able use the certificate (change name to theirs) and add an addendum to the existing certificate only stating modifications (ex: remove table, fix gantry angle etc.)
    Elekta 4.3.2.1 We (Elekta) agree-this should be part of the certification process
    Elekta 4.4.2.3 As a manufacturer of Class II equipment (Elekta), we would like to provide input related to the frequency or circumstance for testing power mains as an EPO. Full power down is very hard on treatment units and following this, there is a very good chance that the unit will not then be operable after. Our recommendation is that power mains are only tested during assigned service days, by FSE-giving them time to trouble shoot, if needed.
    Elekta

    		 4.5.2.1 Regarding re-certification, we (Elekta) do not agree this is necessary for us and our Service only license. We have a National RSO who has produced, and subsequently oversees the Radiation Safety Program. They write, review, and revise our RS procedures; therefore, they are always fully aware of what is current. They also produce all of our applications and submissions to CNSC, so it would be easily apparent to both CNSC and Elekta if they were not qualified, or not performing their job properly.
    Elekta Section 4.6

    		 We (Elekta) agree
    Elekta Overall Impact Excellent suggestions for revisions!
    Michael Evans
    Mcgill    		 Overall Impact I thought the proposed changes were appropriate and mostly tried to harmonize regulations with current practice. In addition, many of the proposed changes will make navigation of the regulations a bit easier for license holders.
    Michael Evans
    Mcgill    		 4.4.2.5 One suggestion (4.4.2.5) I disagree with. The proposal to remove the requirement for patient viewing may make some regulatory sense, but it introduces unnecessary risk to the patient. It is needlessly downloading this responsibility to other jurisdictions and will create the possibility for reduced safety. The CNSC currently requires other tests (such as daily output verification) which ensure patient safety, so why relax this simple requirement. In our practice with HDR brachy treatments I would find this especially worrisome and would prefer that the CNSC continue to require this simple safety requirement. It already reflects current practice.
    Michael Evans
    Mcgill    		 4.2.3.1 I particularly liked the proposal in 4.2.3.1 which suggests proposed weekly or per-shift radiation dose limits. This begins to nudge CNSC in the direction of considering Time Averaged Dose Rate (as suggested by NCRP 151) in design criteria. For example, the criteria that the 25 microSv/hr Instantaneous Dose Rate (IDR) be a limiting shielding criterion is somewhat problematic especially for medical linacs with robotic devices such as the CyberKnife. The USNRC currently uses discretionary judgement to use TADR, rather than IDR, in assessing design criteria. So, I think the suggestions by CNSC for changes in 4.2.3.1 are a step in the right direction.
    Bryce Nelson 4.1.1.1 Regarding the subsection "4.1.1.1 Proposed change: Revise the definition of Class II prescribed equipment to include all particle accelerators capable of producing nuclear energy, with no explicit upper or lower limit on beam energy.": Would it be possible to irradiate target materials such as thorium, uranium, radium, or plutonium on a 24 MeV proton cyclotron (e.g., a TR-24)? There is significant interest in producing short-lived alpha emitters for highly potent targeted alpha particle therapy of advanced cancers, and based on nuclear reaction cross-section data, a TR-24 is well suited for producing useful amounts of Pb-212 (from proton irradiation of thorium) and Ac-225 (from proton irradiation of radium) for research and clinical application. Provided the appropriate cyclotron target technology is employed where the target material is securely encapsulated to prevent any contamination, and any post-irradiation target processing is performed within a separate dedicated alpha lab, would this be possible? Due to the significant global shortage of these desirable therapeutic alpha emitters, we are very interested in pursuing this route to achieve a domestic supply for research and clinical application. Thank you.
    Jeff Konieczny 4.4.2.5 I think the requirement for a patient viewing system should remain in place for medical accelerators. The viewing system is used not just for patients, but to ensure that no one unexpected is in the bunker. Physics testing (especially during commissioning) can deliver massive amounts of radiation making it critical to ensure the room is empty. The bunker is checked before the last person out (LPO) button is pressed but having a full view of the room before actually turning on the beam is very important for radiation safety.
    Jeff Konieczny

    		 4.5.2.1 I agree that recertification is important to ensure competency of RSO's. If recertification is required, it would be a good idea to provide the RSO's with links and references to the study material well in advance.
    Mevex Corporation, a STERIS company



    		 4.1.2.1

    Some sites will consist of a general purpose building that contains a Class II facility. For example, there are some installations in the works that include a compact shield around the Class II equipment, and this shielded system is located within a warehouse and office space to allow the associated activities to operate in the same space as the irradiation activities. Is the intent to license the entire building, or only the components of the shielding, safety system, and equipment inside the building that make up the "Class II facility"?


    I would like to see the scope of the Class II facility limited to the shielding, equipment, and safety systems associated with the accelerator. If the scope of the Class II facility includes the surrounding building, it will add unnecessary cost and complexity to the licensing process and overall use of the building.
    Mevex Corporation, a STERIS company


    		 4.2.1.1 Our business involves continuous improvement and evolution of the design of accelerators to increase capability and power output available. Does this mean we would be subject to the Class I high level safety and security requirement as well as a license condition handbook? The proposed change does not provide enough clarity about the differentiation between "standard" and "non-standard" to determine if this proposed change would affect our operations. If it does, the impact would be significant, both financially and from the perspective of added regulatory burden.
    Mevex Corporation, a STERIS company 4.2.5.1 Many of the service activities are performed through knowledge gained by on-the-job training, may involve elements of troubleshooting and problem solving, and are not typically fully described in "standard servicing procedures". How will the CNSC handle a licensee the does not have a complete set of service procedures covering all models and variants of accelerator in service?
    Mevex Corporation, a STERIS company

    		 4.3.3.1 It's not clear to me whether or not we would be required to certify each accelerator we produce and test prior to shipping to a customer site.
    Mevex Corporation, a STERIS company


    		 4.3.2 Would this requirement apply to the accelerator, the control system, the shielding system, the power supply, or the entire system once assembled?
    Mevex Corporation, a STERIS company



    		 4.3.2.2 Description of the interlock system may require significant work and will add to the regulatory burden.
    Mevex Corporation, a STERIS company




    		 4.4.1.1 Our systems do not presently have a radiation detector within the controlled area. The operating environment inside the bunker is extremely challenging and sensitive detection equipment will fail in a very short time. We display that the system is in a "beam on" state, but this is based on the ability of the machine to produce radiation rather than based on a radiation measurement directly.
    Mevex Corporation, a STERIS company





    		 4.4.2.3 Will there be a test frequency imposed? We typically install and test 2-4 new accelerators in each of our bunkers each year, and test the safety system at the time of installation of each new accelerator. The frequency is event-based (new accelerator installation) as opposed to time-based. Will this approach be acceptable under this proposed change? We would be open to a maximum interval (eg. 6 months) between safety system tests if there was a machine in continuous operation during that period.
    Mevex Corporation, a STERIS company





    		 4.5.2.1 Suggest that the recertification requirement consider the type of class 2 facility. As an OEM, the RSO roles at our company are continuously involved in the design, analysis, and safety assessment of the machines. While recertification seems generally a reasonable, it may provide little value at an OEM facility such as ours
    Mevex Corporation, a STERIS company






    		 4.6.1.1 Guidance on the level of detail required for service records would be helpful. Our company has a team of several people continuously involved in servicing equipment around the world and in Canada. Will we need to maintain service records for all sites globally? What information will be required? The shortest reasonable retention period would help reduce the cost and regulatory burden of this change.
    Mevex Corporation, a STERIS company






    		 4.6.2.1 Our company services equipment around the world. Will we need to retain records for service in other countries?

    Safety operation is largely assured by the safety system, which is generally not touched during service unless the service activities are performed on the safety system itself. Will there be guidance on what level of safety testing is required for service that does not involve the safety system?
    Tara Hargreaves 4.2.3.1 With regards to providing a “description of any proposed weekly or per-shift radiation dose limits to be imposed, and the policy for verifying these doses”, it should be understood that some facilities operate in such a way that personnel do not receive a measurable dose. It is hoped that this would not increase the administrative burden on these facilities and that an annual action level would suffice. If personnel already wear dosimeters from a licensed service provider and do not receive any significant dose, it would not make sense to have any additional limits or dose verification. This should only be required as necessary, depending on the facility and the risk.
    Tara Hargreaves 4.5.2.1 The necessity of recertifying Class II RSOs is questionable. While it is agreed that many duties can be of a dynamic nature, many things are slow to change. Equipment is used for decades and regulations are updated infrequently.

    The Class II RSO also shows continued competence in many ways: during inspections by CNSC inspectors, at the time of licence renewals, when submitting ACRs, by completing refresher training or other maintenance of knowledge and skills. Recertification could be required should a deficiency or non-compliance be found, rather than adding an expiry to the certification.

    It would be very important to consider the frequency of recertification, the method of recertification, and contingencies should a certified Class II RSO fail recertification. This should not add unnecessary administrative burden on licensees that show a good level of compliance.
    Tara Hargreaves

    		 4.6.1.1 Removing the relationship between record retention and licence expiry is fully supported. This is a confusing way to measure record retention periods. It is hoped that this will be changed in the other regulations as well.
    Tara Hargreaves


    		 General Comment The move towards less prescriptive regulations is welcomed. This allows flexibility for situations that may not fit well with overly prescriptive regulations.
    Debbie Frattinger

    Sylvia Fedoruk Canadian Centre for Nuclear Innovation Inc    		 4.2.4.1

    I am opposed to this proposal. Over the years of cyclotron operation the operator(s) and RSO become well versed in the mechanics of the cyclotron. They gain a wealth of knowledge. Therefore, there is no rational why they cannot decommission a cyclotron. It will not be operational going forward. The same procedure will be followed for decommissioning any other facility (not sure about power plants) which the licensee can complete on their own. Furthermore, if the licensee is responsible to ensure the decommissioning activities are completed correctly I would assume they are capable to complete the task then, if they wish. Requiring a valid CNSC servicing licence company to complete the task is an undue expense to the licensee. I personally decommissioned the Saskatchewan Accelerator Laboratory site before it could become the Canadian Light Source saving the University $2.5M if we had to hire it out.
    Debbie Frattinger

    Sylvia Fedoruk Canadian Centre for Nuclear Innovation Inc    		 4.5.2.1

    I am opposed to this proposal. Instead of having the RSO write another exam, I would like to recommend the CNSC collaborate with the CRPA (R) program where RSO’s have to show evidence of relevant continuing education. An initial exam is written, then in order to remain a certified RSO the person needs to maintain credits to ensure their status. There is a list of criteria provided under the program. I believe if CNSC wished to add to this list it would definitely be considered. Working together will harmonize the two requirements and increase the value of a CRPA (R).
    Kellie Franz

    Shared Health    		 4.2.4.1 I am opposed to this proposal. There will be unnecessary expense(s) to licensees. Each
    licensee is qualified to perform or supervise decommissioning of their own facilities.
    Potentially having to hire someone with a CNSC servicing licence would add the burden of .
    Kellie Franz

    Shared Health    		 4.5.2.1 I am opposed to this proposal. This could cause undue stress to an RSO, additional costs to a licensee and further administrative burden to the Class II project officers who would now have to enforce and maintain these certificates as they expire.
    Class II RSOs are already chosen for the position based on their education and experience. Some facilities also invest significantly in additional radiation safety courses to ensure that their RSO has all of the tools necessary to be effective. CNSC assesses these individuals via review of their education as well as administration of an exam prior to certifying them.
    Provided the certified Class II RSO remains in their current role/department, there should not
    be a need to re-certify as they have been actively gaining experience through performing their job and undergoing CNSC inspections. The certification is already nontransferable and the individual would have to be certified for each new site or piece of equipment added to their responsibilities. The CNSC inspection process also already acts as a form of reassessment of these individuals and the CNSC maintains the right to revoke a certification if they feel that something is lacking.
    Julio Panama Section 4.5 I think before any further progress on this proposed changed continues, the change should be clearly defined. Questions such as what will be the recertification period? what would be the recertification process? Need to be defined to avoid confusion. As a general statement such as the one defined in the proposed changes I think recertification of the RSO is unnecessary and only adding regulatory burden. In a short period of time (3 to 5 years) the radiation safety program for which the RSO is responsible to maintain and enforce is audited 2 sometimes even 3 or more times by the CNSC, such inspections should address any deficiencies in the radiation safety program and such in the RSO. I think it would be much better use of time and resources if the CNSC amended section 4.5.2 to include a requirement for minimum education hours in a period of time for the RSO. This would help the RSO to maintain the high level of competency required to manage the radiation safety program.
    Trevor Beniston
    Alberta Health Services - Cancer Care Alberta    		 Main body of DIS22-01 We agree with and support the intent to align the regulations with current practices that are otherwise managed through licensing or very generalized regulatory citations. The shift towards outcome-based results, as opposed to prescribed requirements, is the right move in our opinion as well.
    Trevor Beniston
    Alberta Health Services - Cancer Care Alberta    		 Section 4.2

    		 4.2.3.3 - We agree with this change provided the intent is simply to establish in the regulation what is currently done in practice. 4.2.3.4 - We believe decommissioning and disposal information is best provided during the operating application (for commissioning) before the equipment is turned on for the first time or the sources are onsite. Asking for information both at construction and operating licence steps is duplication. If concerned about changes in information, moving the request to the operating licence ensures the most recent information is obtained before activities with radiation can start. 4.2.4.1 - Clarify: the servicing definition refers to the equipment and not the facility. Is this expected to change with the proposed changes? Having a servicing licence does not automatically confer competency in decommissioning work and vice versa. Decommissioning work is not necessarily servicing work. although there may be an element of decommissioning that require service work (ie: dismantling the prescribed equipment). Dismantling the equipment needs to be performed under a servicing licence, but decommissioning the rest of the facility does not. This could potentially create large costs for a licensee that does not have a servicing licence in order to renovate or remove safety systems from the facility that otherwise could be done by supervision from the licensee. 4.2.5.1 - We agree with this approach to simplify the servicing licence application and focus on the measures to ensure safe work as opposed to the technical service work itself.
    Trevor Beniston
    Alberta Health Services - Cancer Care Alberta    		 Section 4.4 4.4.1.1 - We support the move to outcome-based requirements as it gives much more flexibility to both the licensee and the regulator than the prescribed approach, but more detail is needed to properly comment on the impact. Determining whether radiation is present within a treatment room and displaying this information both within and outside the defined area is potentially a new requirement for linacs – depending on the final wording. Would the proposed accompanying regdoc become mandatory for some licensees? 4.4.2.2 - We agree with this change in principle but further detail on the wording is needed. We would prefer the final wording to be fairly non-prescriptive to give a licensee the maximum amount of flexibility to consider/implement alternative measures that meet the outcome and minimize the amount of CNSC approvals necessary. No issue with notifying the CNSC of an alternative measure but would not want to have to wait for approvals unnecessarily. 4.4.2.5 - We disagree with this change. Viewing systems should remain in place for medical accelerators. Having a viewing system not only protects the patient but also provides a measure of protection to workers. Operators should have the ability to view the facility to ensure no one is present in the room when radiation is produced even when an LPO system is present. The viewing system is an easy system to implement, and it continues the layered approach to safety within these facilities. Removing this requirement reduces the overall safety of the facility even if it may be covered by another regulatory body.
    Trevor Beniston
    Alberta Health Services - Cancer Care Alberta    		 Section 4.5 4.5.2.1 - Are there concerns that current CII RSOs are not demonstrating competency or is there a trend which suggest this is becoming a problem? We generally disagree with the proposed change as RSO proficiency is already evaluated during CNSC inspections and (to a lesser extent) through the ACR. An additional recertification process for RSOs creates more administrative burden (for both licensees and the CNSC) with little gain in our opinion as the RSO is regularly performing the duties of the role for a single licensee/employer. The current certification only applies to the RSO position for a specific licence and is not transferable. The certification is more of a licensing requirement than a professional certification. Perhaps if it became transferrable and used as means of demonstrating the RSOs specific skill set, professional knowledge or ability to fulfil the role of the RSO, periodic recertification would carry more importance. If there is a concern about RSO competency over time, then we suggest using a maintenance process (similar to what the CRPA uses) that considers continuing education, continuous employment as an RSO, and other relevant qualities. We would be opposed to simply writing an exam every so many years.
    Jonathan Doupe 4.1.1.1 The proposed change is to incorporate >50 MeV accelerators (now Class IB) within the Class II regulations. The radiological risks of the two types of accelerators are similar, and some of the challenges faced by Class I facilities in terms of containment, releases to the environment, etc. are not faced to nearly the same degree in Class IB. With this proposed reclassification, it is natural to ask what operations currently conducted at Class IB facilities might also be performed at Class II facilities. There is a great deal of interest in using high-energy cyclotrons to produce therapeutic isotopes for cancer treatment as demand is outpacing supply (e.g., Ac-225 produced at TRIUMF from a 480 MeV proton beam hitting a thorium target). These reactions usually require high energies but not all. For example, Pb-212 could be produced from 24 MeV protons on thorium. Obviously safeguards and Nuclear Material Accountancy would be critical in such work along with proper radioactive waste management. Thorium or radium targets would be much easier to manage in this respect than heavier elements. Reasons as to why Class IB facilities were first in this work on heavy element targets include i) many more nuclear reactions were available at high energies, ii) Class I facilities by their very definition deal with nuclear materials, iii) there was already in-house experience in terms of chemistry and regulatory aspects of alpha-emitters. If the present radiological risks of Class IB and Class II accelerators are judged similar - and that would include the work on heavier element targets in Class IB - then it is worth reassessing what can be done at Class II sites, particularly since there is a need for new supplies of therapeutic isotopes.
    Canadian Nuclear Laboratories (CNL) Please see attached table CNL comments on DIS 22-01
    General Fusion Please see attached table General Fusion comments on DIS 22-01
    Lesley Buckley Section 4.2 4.2.2.6 Additional requirement to provide the proposed method of disposing of the the CII PE within the construction license - Any change of this nature needs to recognize that very often the lifetime of the CII equipment is more than a decade, so there should not be an expectation that any great amount of detail could be provided at the time of the construction license. 4.2.3.4 Same comment as 4.2.2.6
    Lesley Buckley Section 4.4 4.4.2.2 I agree with this change as it facilitates taking reasonable temporary precautions without delaying operation and without compromising safety 4.4.2.5 I disagree with the removal of the requirement for a viewing system. While this system is used for patient treatments in some cases, it also plays an important radiation safety role during beam operation and most centres instruct staff that for radiation safety purposes they must always operate with the viewing system on, even during service or commissioning work. Within a radiation therapy setting, no centre would remove these systems for patient treatments. However, having clear regulations requiring these systems as part of the radiation safety system ensures that centres are able to install these system from the first beam on and that they will form an integral part of the safety systems. They also facilitate greater frequency of verifying the functionality of the in-room safety systems and their removal could lead to proposals for a reduced frequency of testing of other safety systems since daily testing would not, in the absence of a viewing system, be reasonable. If they desire is to remove this requirement for some CII facilities, perhaps this could make use of the proposed definition of 'medical accelerator' (4.1.1.2) and keep this requirement for those settings.
    Lesley Buckley Section 4.5 4.5.2.1 I agree in principle with the periodic expiry of RSO certificates which is in line with other professional certifications. Perhaps 'renewal' rather than 'recertification' is a more appropriate approach. For RSOs carrying licenses that have had successful audits, active licensing and that have remained compliant, this may be sufficient for a renewal of the certificate. Performance based renewal would be more effective than an exam based recertification. The exam will confirm the base knowledge required to carry out the RSO role but will not give information about how well the individual performs in the role so repeating this process will not give the CNSC any additional information about the individual. I would encourage the CNSC to add more detail to the type I inspections that focusses specifically on the RSO performance. This would allow for more targeted feedback, or direct suggestions for performance improvement. Although the evaluation of the RSO performance is subjective, the CNSC already takes a similar approach when looking at safety culture of licensees. 4.5.2.2 I agree completely. Equipment changes, new programs are added and the list of licensed activities on the RSO certificate is sometimes overlooked. A simple amendment process would reduce the administrative overhead for both parties.
    Lesley Buckley Section 4.6 4.6.1.1 I agree with this proposal and think that linking the record retention to the removal from service makes far more sense than tying it to a license that may be renewed so frequently that it never actually expires.
    Ontario Tech University Please see attached table Ontario Tech University comments on DIS-22-01
    Bruce Power Please see attached table Bruce Power comments on DIS-22-01
    McMaster University Please see attached table McMaster University comments on DIS-22-01
    University Health Network Please see attached table University Health Network comments on DIS-22-01
    Deanne Dombrosky
    CancerCare Manitoba     		Section 4.1

    		 4.1.1.1 Proposed change: Revise the definition of Class II prescribed equipment to include all particle accelerators capable of producing nuclear energy, with no explicit upper or lower limit on beam energy. CCMB is in favour of this change. It doesn't affect cancer centres directly, as proton accelerators operate below 150 MeV. We concur that the radiological risk from higher energy accelerators does not warrant classification as a Class I facility. 4.1.1.2 Proposed change: Add a definition for “medical accelerator”. CCMB is in favour of this change. The stringent safety system checks needed for a healthcare facility with much more public access are not necessarily applicable to an industrial or research facility with existing access control. We support this change on the condition that facilities with more public or non-NEW access have appropriate safety measures as part of their license condition, including ones that would not normally be required if the facility design warrants it. 4.1.2.1 Proposed change: Define a Class II facility as one that includes Class II prescribed equipment fixed in place inside a shielded room or other enclosure, as well as its related components, systems and equipment. CCMB is in favour of this change. Our Class II equipment's supporting infrastructure is treated as part of the installation from an administrative perspective, and the CNSC already approves its use and audits how well it is maintained during inspections.
    Deanne Dombrosky
    CancerCare Manitoba     		Section 4.2 4.2.1.1 Proposed change: Design the C2NFPER in such a way that standard facilities would continue to follow the approach used throughout the current regulations. Non-standard facilities, however, would follow an approach similar to that currently used for Class I facilities, where broad, high-level safety and security requirements are in place and a licence conditions handbook (which describes in detail how the licensee will conduct its operations in a safe and secure manner) is developed and incorporated into the licensing basis. Furthermore, it is proposed that equipment licensed under the non-standard stream would be exempt from certification (see section 4.3.1.2 for details). CCMB is in favour of this change. It will not change our operating and administrative costs as our Class II equipment is all well-characterized and mass-produced. A separate stream for custom accelerators versus commercial is a great idea; it would allow for project officers to be intimately familiar with the types of sites that they are responsible for. 4.2.2.1 Proposed change: Require radiological workload and beam-related parameters (where applicable) for all Class II prescribed equipment, not only teletherapy machines. CCMB is in favour of this change. It will not change our operating and administrative costs as we already report estimated workload during construction license applications and Annual Compliance Reports. 4.2.2.2 Proposed change: Remove the requirement to provide the anticipated number of hours per week that the Class II facility will be operated for specific uses (treatment, dosimetry, servicing or research). CCMB is in favour of this change. It will reduce the burden of applying for licenses. 4.2.2.3 Proposed change: Remove the current requirement to provide the proposed responsibilities of and training program for workers during the operation of the facility. CCMB is in favour of this change. This could reduce the waiting time for processing of a construction license. 4.2.2.4 Proposed change: Clarify that a description must be provided of all safety systems that are required under section 15 of the C2NFPER. CCMB is in favour of this change. This would harmonize the C2NFPER with REGDOC 1.4.1 and removing ambiguity, which is always helpful. 4.2.2.6 Proposed change: Add a requirement that the proposed method of disposing of Class II prescribed equipment (and any activated components or materials) be provided with the preliminary decommissioning plan. CCMB is in favour of this change. It will not change our operating and administrative costs as we already plan for this. It would be helpful for newer facilities that are less familiar with disposing of activated accelerator components to avoid the surprise of needing to deal with activated targets, etc. when replacing or upgrading an accelerator. 4.2.3.2 Proposed change: Require radiological workload and beam-related parameters (where applicable) for all Class II prescribed equipment operating in a shielded facility, not only teletherapy machines; in addition, remove the stipulation that workload must be tracked on a weekly basis and in units of grays measured at a distance of 1 m. CCMB is in favour of this change. It will not change our operating and administrative costs as we already provide this. The removal of the weekly tracking will align with what is currently happening. 4.2.3.3 Proposed change: Require applicants to submit the proposed methods and frequency for testing the safety systems set out in section 15 of the C2NFPER, as well as any installed security systems. CCMB is in favour of this change on the condition that the requirement is to submit methods and frequency for testing safety systems, as opposed to specifying what that frequency must be. The testing interval should be tailored to the installation. As an example, at our sites testing the emergency stop buttons is part of our accelerators' planned maintenance every five weeks; requiring the testing of the e-stops more frequently would place undue stress on the equipment. 4.2.4.1 Proposed change: Ensure decommissioning activities are performed only by (or under the supervision of) persons or entities who hold a valid CNSC servicing licence. This doesn't affect CancerCare Manitoba personally as we hold a servicing licence. This will affect facilities that do not have servicing licences. It is likely better to put this in a REGDOC rather than in the C2NFPER. 4.2.5.1 Proposed change: Add a requirement to provide a description of the methods and/or equipment that will be used to ensure safety during servicing operations (e.g., defining circumstances or dose levels that require workers to “back out” of a situation, or steps to take when a situation arises that is not covered by standard servicing procedures); conversely, remove the requirement for applicants to submit their standard procedures and/or equipment for performing servicing (a table of contents of such standard procedures may be requested instead). CCMB is in favour of this change. It will put a small burden on our facility now, but will GREATLY reduce the burden in the future as we move to newer systems that have different service procedures.
    Deanne Dombrosky
    CancerCare Manitoba     		Section 4.3 4.3.2.1 Proposed change: Add a requirement to provide the proposed method for securing Class II prescribed equipment that contains a nuclear substance. CCMB is in favour of this change on the condition that equipment currently appearing on a CNSC licence will be accommodated for the lifetime of the equipment (similar to 4.3.1.1 for uncertified research equipment that will have a clause added to accommodate the licensees for the lifetime of the equipment). We are concerned about when a device is re-certified: how will existing devices be handled if they do not have an appropriate strongpoint? Will already-sold devices have an exemption, since their end-users have likely already found an appropriate solution?
    Deanne Dombrosky
    CancerCare Manitoba     		Section 4.4 4.4.1.1 Proposed change: Replace the current prescriptive requirements with the following outcome-based requirements: • An area must be defined wherein no persons (other than the patient in a medical facility) shall be present while the Class II prescribed equipment is operating (the “controlled area”). • Irradiation must be prevented until someone enters the defined area where the Class II prescribed equipment is located and ensures that the controlled area is clear of other people and that the equipment is safe to operate. • Irradiation must be stopped automatically if someone enters the controlled area while the prescribed equipment is operating. • There must be a method of determining whether radiation is present within the controlled area and of displaying this fact both within and outside the defined area. • Radiation warning signage and emergency contact information must be posted at the entrance to the controlled area. CCMB is mostly in favour of this change as they are satisfied with existing practices. Outcome-based requirements are a good idea, as long as the REGDOC gives appropriate guidance. The Class II application guide REGDOC is a good model to follow in this respect. We are concerned about the "method of determining whether radiation is present," and “display must be within and outside defined area”. For medical linear accelerators the existing solution is "Radiation On" signs at the vault entrance. We do not want to see area monitors being made necessary for linear accelerators, nor signs required within the vault. Language specifying that accelerator radiation sources may use devices that indicate when the accelerator is active should be added to make this explicit. 4.4.2.2 Proposed change: Allow licensees to propose and implement alternative or additional safety precautions in the event of a failure of an installed and approved safety system. CCMB is in favour of this change. It is a welcome change that would formalize existing practice. 4.4.2.3 Proposed change: Add a requirement that licensees must test all installed safety systems on a regular basis. CCMB is in favour of this change on the condition that the requirement is to submit methods and frequency for testing safety systems, as opposed to specifying what that frequency must be. The testing interval should be tailored to the installation. As an example, at our sites testing the emergency stop buttons is part of our accelerators' planned maintenance every five weeks; requiring the testing of the e-stops more frequently would place undue stress on the equipment. 4.4.2.5 Proposed change: Remove the requirement for a patient viewing system. CCMB is not in favour of this change. The other application of the viewing system that does fall under CNSC mandate is that it allows staff to see if there is anyone in the room other than the patient (this is in addition to the Last Person Out device). If CNSC is not suggesting that viewing systems be removed, then there are no operating and administrative costs to be saved by this change.
    Deanne Dombrosky
    CancerCare Manitoba     		Section 4.5 4.5.2.1 Proposed change: Add a provision under which certificates issued to Class II radiation safety officers will expire after a certain period, to be defined by the CNSC. Consequently, a clause that will require periodic recertification of a Class II RSO will also be added. CCMB is not in favour of this change. Requiring certified RSOs to study for and take regular recertification exams would increase operating, administrative and financial costs without any proven benefit. During each CNSC inspection the RSO’s knowledge and competency is evaluated through the evaluation of the Radiation Safety Program. If concern is raised then actions can be required through the Inspection report. We would instead propose requiring a specified number of continuing education credits over a set time period, similar to CRPA(R), to retain certification. The CNSC could provide a listing of topics or courses that would be accepted based on the RSO’s facility type. This would ensure the RSO maintains the required current knowledge. This would also require the licensee to provide time and funds for RSOs to take continuing education, both of which may be difficult to obtain for some RSOs. Required continuing education would be much more helpful for ensuring the RSO has current knowledge than writing exams. 4.5.2.2 Proposed change: Add language allowing the amendment of certificates issued to Class II radiation safety officers. CCMB is in favour of this change. RSO certificate amendments are a very good idea, especially with equipment on site changing and upgrading constantly.
    Deanne Dombrosky
    CancerCare Manitoba    		 Section 4.6 4.6.1.1 Proposed change: Remove the relationship between record retention period and licence expiry. Instead, it is proposed that: • equipment-related records be retained for a certain period following the day on which that equipment was removed from the licence • servicing records be retained for a certain period following the day on which the servicing was performed. CCMB is in favour of this change. This will greatly reduce regulatory burden on the licensee. For facilities where the site license doesn't expire, this will allow the disposal of records that aren’t needed. 4.6.2.1 Proposed change: Ensure that records of servicing of Class II prescribed equipment are: • kept and retained by the entity who performed the servicing • provided by the entity who performed the servicing to the operator/owner of the prescribed equipment • kept and retained by the prescribed equipment operator/owner. CCMB is in favour of this change. It will not change our operating and administrative costs as we already retain servicing records.
    Association québécoise des physicien(ne)s médicaux cliniques

    		 Please see attached table


    		 AQPMC comments on DIS-22-01
    Peter McGhee

    		 Main body


    		 Overall the initiative and intent of proposed changes is most appropriate and welcomed. Further responses are in support of several points of concern already identified by others.

    Peter McGhee

    		 4.2.2.6

    		 Given the typical expected lifetime of Class II equipment there are very likely details that may not be specifically available when establishing the decommissioning plan. For example, there are different approaches offered by a variety of vendors that may be engaged at the time of actual decommissioning, so provision of that level of detail at the time of installation is unlikely to be possible. As currently presented, level of detail that may be introduced is unclear.
    Peter McGhee

    		 4.4.2.5 Ostensibly, perhaps, patient viewing systems do not fall under the purview of the CNSC but in practice it is a particularly grey area. Operating a treatment unit without a viewing system is fundamentally a bad idea with regard to safety and these systems are often used for other purposes, such as verification of the functionality of in-room warning indicators or simply as a secondary measure to ensure that no one is inadvertently in the treatment suite when radiation is being produced. Having systems in place that ensure or bolster safety for anyone proximal to operation of licensed equipment should be considered a requirement given that safety is an underlying principle that guides the CNSC in the development of regulations; the requirement should remain.
    Peter McGhee

    		 4.5.2.1 A review and assessment of ongoing competency is always a good idea and certified RSOs should not be exempted from such a process. Given that licensed facilities are subjected to routine inspections, would it not be more reasonable to incorporate a specific assessment of the responsible RSO into that process? Ongoing renewal of certification after a set period seems overly cumbersome. Moreover, how is the situation where an RSO loses certification to be handled, i.e., what would be the consequences? In the extreme, would it mean immediate suspension of operations? A more reasonable approach may simply be to, outside of exceptional situations, identify inadequate performance of a certified RSO to fulfil responsibilities during a routine inspection. The consequence would then be a Notice of Noncompliance that would need to be addressed by the licensee. Given the frequency of such inspections, a reasonable measure of maintenance of competency should be realized.
    Tara Hargreaves
    		 4.5.2.1
    		 The rational for adding a recertification requirement for Class II RSOs should be carefully considered. If there is not a solid reason for needing the recertification, then it should not be required. To maintain up-to-date records of certified RSOs, some sort of renewal could be considered, a check-in to verify information and that the RSO is still active. The method and frequency of recertification can only be suggested when the reason for requiring recertification is known. Perhaps other qualifications that must be maintained, such as the professional designation from the CRPA, could stand in for a recertification with the CNSC. Potential stress and burden on individuals and organizations must be carefully considered when implementing any further requirements. Hazard level of the equipment/facility and compliance rating for the licence could also be considered when determining the need for recertification.
    OPG Please see attached table OPG Comments on Dis 22-01
    Jeff Dovyak

    Shared Health Manitoba    		 4.2.4.1 Proposed change: Ensure decommissioning activities are performed only by (or under the supervision of) persons or entities who hold a valid CNSC servicing licence.

    It is gratifying to see that I am not the only Radiation Safety professional who opposes this proposed amendment. The points raised by Ms Franz, Ms Frattinger and Mr Beniston as well as McMaster University and Mr Arnaldo with Ontario Tech University (OUT) particularly resonate with me.
    Jeff Dovyak

    Shared Health Manitoba
    		 4.5.2.1 Proposed change: Add a provision under which certificates issued to Class II radiation safety officers will expire after a certain period, to be defined by the CNSC. Consequently, a clause that will require periodic recertification of a Class II RSO will also be added.

    Again I’m glad to see that I’m not the only one who opposes this proposed amendment. Comments from Dr Galea, Mr Hardy, Ms Franz, Ms Hargraves, Ms Frattinger, Ms Dombrosky and Mr Beniston as well as McMaster University, University Health Network and Mr Arnaldo with OTU again resonate with me. I should also say Dr Buckley’s comments here regarding ‘renewal’ vs ‘re-certification’ are well thought out.