Proposed Regulatory Amendment to Reg. 543 s.3 (2): X-Ray Safety Code for adopting updated requirements for shielding methodology under the Healing Arts and Radiation Protection Act (HARPA)
Regulation - LGIC
Bill or Act:
Healing Arts Radiation Protection Act
Summary of Decision:
The ministry is making a regulatory amendment to bring Ontario's regulation in line with the federal standard by adding a reference to NCRP 147. This would allow facilities that wish to install x-ray machines the flexibility to align with the existing standard in Appendix 2 of Health Canada Safety Code 20A (which is based on NCRP 49) or the new standard in NCRP 147. A French language version of the regulation is also being made, along with the correction of several minor typographical errors.
Specifically, there is an amendment to add reference to NCRP Report No. 147-Structural Shielding Design for Medical X-Ray Imaging Facilities, revised on March 18, 2005 and published by the U.S. National Council on Radiation Protection and Measurements.
Analysis of Regulatory Impact:
The proposed regulatory amendment balances opportunities to support adoption of new technology and modern shielding requirements, while maintaining safety and quality protections. This proposed change was directly informed by a comprehensive consultation process and can be implemented within the existing HARPA framework.
This proposed regulatory modernization is anticipated to result in financial savings to medical stakeholders by giving them an option to use lower threshold / less conservative shielding requirements for construction. Updating outdated technology to come in line with the new proposed requirements may result in costs, but adoption of the new shielding methodology is voluntary and based on their technical readiness and operational need.
October 7, 2021
Summary of Proposal:
The Ministry of Health (MOH) is proposing a regulatory amendment to the Healing Arts and Radiation Protection Act (HARPA), Regulation 543 to modernize the shielding methodology for x-ray installations. The ministry is proposing the following:
Amend HARPA Reg 543 section 3 (2) to replace compliance with Health Canada's Safety Code 20A with the most recent Safety Code 35 for shielding methodology.
• Delete reference to Appendix 2 of Safety Code-20A - X-Ray Equipment in Medical Diagnosis Part A: Recommended Safety Procedures for Installation and Use, published by the Department of National Health and Welfare.
• Add reference to Safety Code 35 for shielding methodology only, published by the Consumer and Clinical Radiation Protection Bureau of Health Canada.
This proposed amendment does not impact the existing dose limits specified in Reg 543 section 3 (1).
Shielding methodology from Safety Code 20A based on National Council on Radiation Protection and Measurements (NCRP) Report #49 is contained in Safety Code 35. This proposed amendment will not impact any facilities that need to continue using shielding methodology from Safety Code 20A. Safety Code 35 allows for the use of either the most recent international guidelines (NCRP Report #147 - updated in 2004 and adopted by Health Canada in 2008) or the original guidelines (NCRP Report #49 - developed in 1976). This proposed amendment would bring provincial regulation at par with provincial counterparts and international best practices and would support Ontario's modernization work.
Operational documents that support the proposed regulation change will be updated by the ministry to support implementation (e.g., general information pamphlets and relevant forms for plan approvals).
These proposed changes would come into effect on a date to be determined. It is anticipated that the effective date will be no later than July 1, 2022.
Safety Code 20A is based on methodology developed in 1976 (NCRP Report #49). Health Canada replaced Safety Code 20A in 2008 with Safety Code 35 to reflect the adoption of most recent international guidelines (NCRP Report #147) as the recommended methodology while also allowing the use of NCRP Report #49.
Strategic Policy Unit, Ministry of Health
438 University Avenue, 10th Floor,
Toronto ON M5G 2K8
February 25, 2022