Modernization of the Radiation Emitting Devices Act (REDA) 2020 Consultation - Summary of Results
What is REDA and Why is Modernization Necessary?
Health Canada helps to protect Canadians against unsafe radiation emitting devices through the administration of the Radiation Emitting Devices Act (REDA). REDA governs the sale (including re-sale), lease, advertising and importation of radiation emitting devices in Canada; that is, devices that emit radiation in the form of electromagnetic energy (e.g. x-rays, microwaves, radiofrequency (RF) waves, infrared (IR), visible light and ultraviolet (UV) light) or acoustical energy (e.g. sound and ultrasound). Devices that fall under REDA can be categorized as medical devices (e.g. medical x-ray and ultrasound equipment), consumer products (e.g. microwave ovens and cellular phones), or industrial/commercial products (e.g. airport security screening equipment, and tanning beds).
In view of technological advances, increasing globalization, and the significant increase in the number and types of radiation emitting devices imported, leased or sold in Canada, it is important that REDA reflects modern and future radiation emitting device contexts. Modernization of the legislation is necessary in order to bring the Act into line with the authorities and language of other modernized Health Canada legislation and to provide more agile authorities to the Minister in the oversight of existing and emerging radiation emitting devices.
About the Consultation
Health Canada's Environmental and Radiation Health Sciences Directorate undertook a 60-day web-based consultation between July 13, 2020 and September 11, 2020, to gather comments from regulated parties and interested Canadians on the potential impacts of changes being considered in the modernization of REDA. Stakeholders were furthermore encouraged to identify current or foreseen challenges posed by the existing statute in the context of an emerging technology environment.
A consultation guide, which included a list of proposed changes, as well as a series of questions to gain specific information to assess economic and other impacts on regulated parties, was shared through the Health-Related Consultations website on Canada.ca. Key stakeholders were furthermore made aware of the consultation through email. Due to the challenges posed by social, economic and health impacts of the COVID-19 global pandemic, the Department exercised flexibility and continued to give consideration to comments submitted well after the stated closure date.
A total of 20 stakeholder submissions were received. Respondents included:
- Interest groups
- Professional associations
No feedback from Indigenous populations was received through the mechanisms identified above. REDA is technical in nature and as such, impacts or relevancy specific to any particular demographic subset of the Canadian population, including Indigenous populations, has not been identified.
In general, respondents were supportive of the work to modernize REDA, though some issues were raised by specific groups.
Interest Groups and Individuals
Although many of the special interest groups and individuals expressed general support for strengthening the provisions of REDA, concerns were raised in relation to the application of REDA to address noise emissions from wind turbines. Respondents expressed a desire to ensure that the provisions of REDA, specifically the general prohibition and notification requirements, apply to wind turbines as well as other products that emit tonal infrasound.
Professional associations that participated in the consultation were generally supportive of proposed changes.
One industry organization focussed comments and suggestions in the context of laser-emitting products. These comments were not in relation to specific legislative requirements of REDA. Rather, they pertained to regulatory considerations or aspects falling under provincial jurisdiction.
Another industry association concerned with radiation emitting medical devices recommended the exemption of medical devices from the scope of REDA, the rationale being that medical devices are already subject to the requirements of the Food and Drugs Act (FDA) and Canadian Medical Device Regulations (MDR). Failing this, the group advocated for the alignment of proposed requirements under REDA with those currently under the FDA and MDR. Concerns were also expressed about the possibility of duplicate requirements and the security of confidential business and personal health information. A request was made for clarification with respect to the potential implications and implementation of specific terms and authorities.
Health Canada thanks all stakeholders for their input to the consultation. Feedback is being reviewed and some provisions may be reconsidered in light of comments received.
Information on economic or trade impacts, although requested as part of the consultation, was insufficient. Consequently, additional targeted stakeholder outreach and consultation efforts are planned to supplement feedback already received.
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