Proposed modernization of the Radiation Emitting Devices Act
Health Canada is seeking stakeholder perspectives with respect to potential impacts of changes under consideration for the Radiation Emitting Devices Act (REDA). The intention of the proposed changes is 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. Stakeholders are furthermore encouraged to identify current or foreseen challenges posed by the existing statute in the context of an emerging technology environment.
The following amendments to REDA are currently under consideration:
- Addition of a Purpose section, a feature found in other federal legislation, including the Canada Consumer Product Safety Act (CCPSA). The provision would state that REDA helps to protect Canadians by addressing or helping to prevent human health and safety risks associated with radiation from radiation emitting devices.
- Addition of new definitions and amendments to existing ones under the Interpretation heading of the Act. Definitions for "confidential business information", "document", and "danger to human health and safety" would be added, while definitions of "radiation", "radiation emitting device", and "sell" would be amended as follows:
- Radiation: addition to the definition that it is emitted from a device "as the result of the operation of an electronic circuit in such device".
- Radiation emitting device: same addition as to the definition of radiation (above).
- Sell: add lease to the definition to simplify other sections of the Act and streamline language throughout the Act.
- Addition to the non-application provisions (section 3). Specifically, consistent with the exclusion of motor vehicles within the meaning of the Motor Vehicles Safety Act from the application of REDA, exclusions for other modes of transportation are being contemplated (e.g., rail, marine, air). In addition, exclusions for radiation emitting devices pertaining to the Department of National Defence or the Canadian Forces are under consideration.
- Expansion of the prohibition described in section 4 to prohibit a person from manufacturing, importing, advertising or selling a radiation emitting device that is a danger to human health or safety, does not meet applicable regulatory requirements as set out in the REDA Regulations, is subject to a recall or other order (see new authorities, below), or is a prohibited device (see new authorities, below). This would align REDA with authorities set out in other legislation governing consumer products (i.e. CCPSA) and medical devices (i.e. Food and Drugs Act (FDA)).
- Broadening the deception provision (section 5) to include "sell" in the activities listed, consistent with the language of the CCPSA (s.10) and the FDA (s.20).
- Changing the Act's requirements for notification for manufacturers and importers, consistent with the proposed changes to section 4 of the Act. Specifically, when a manufacturer or an importer of a radiation emitting device becomes aware of an incident that relates to a serious health and safety risk due to radiation from their device, they must report it to the Minister. An incident could include a recall or measure initiated for the purpose of mitigating radiation risk to human health and safety (includes those of foreign entities, provincial governments, public bodies established under an Act of the legislature of a province, an aboriginal government or any institution of the aforementioned entities) as well as conditions that result, or can reasonably be expected to result, in an individual's death or serious adverse effect on their health, including:
- a serious injury, including an occurrence in Canada or elsewhere;
- a defect or characteristic; or
- incorrect or insufficient information on a label or in instructions - or the lack of a label or instructions.
- Strengthening of inspection authorities, consistent with other legislation administered by Health Canada to include, among other things, an authority to:
- enter any place or cross private property where a radiation emitting device is manufactured, imported, packaged, stored, advertised, sold, labelled, tested or transported, or where a record, report or other data related to REDA or the regulations might exist;
- examine or test anything;
- examine or make copies of documents/records;
- use or examine a computer, or other device on the premises, take photographs, or make sketches;
- order a person on the premises to establish their identity, or to move or restrict movement of an, or to start/stop an activity;
- enter a premises through a network, with the knowledge of the owner;
- make use of a tele-warrant, where practical.
- Strengthening of the requirement to provide assistance to Inspectors (section 8) by expressly stating that the word "information" includes a document or access to any data, electronic document, test results, or anything that the inspector would require to perform their duties and functions with respect to compliance and enforcement in the administration of the Act. In addition, the provisions of the Act pertaining to obstruction, false statements, and interference (section 9) would be aligned with those in other legislation administered by Health Canada.
- Broadening the scope of inspection, forfeiture and disposition powers, to align with modern legislation, by including any article to which the Act or the regulations apply that is found in a place or a conveyance (rather than simply a radiation emitting device).
- Addition of a regulation-making authority to authorize the prohibition of manufacturing, import, sale, or advertising of radiation emitting devices.
- Strengthening the Offence and Punishment provisions of the Act, with a scheme and penalties sufficient to deter non-compliance. Among other things, the amendments would encompass officers, directors, agents or mandataries of a corporation who authorized, directed assented to, acquiesced or participated in the commission of an offence.
- Addition of a provision that would authorize the importation of specific non-compliant devices for a specific time period and for a specific purpose, such as for demonstration purposes at a trade show.
- Strengthening the authority of the Minister as it relates to requiring information from manufacturers or importers, consistent with recently introduced Health Canada legislation. This information would assist the Minister for such things as verifying compliance with the Act, assessing risk to health, locating devices, or notifying affected stakeholders in the event of a recall of a device. The provisions would also include protections for personal information and confidential business information received in the administration or enforcement of the Act or regulations. Authorities required would include:
- compelling of tests and the results of tests or studies;
- requiring any information that the Minister considers necessary to verify compliance or enforce the Act or its regulations; and
- a requirement to prepare and keep records related to the distribution of radiation emitting devices for a prescribed period.
- Addition of an authority, consistent with other Health Canada legislation to allow the Minister to disclose confidential business information to a person or a government that carries out functions relating to the protection of human health or safety.
- Addition of an express authority to incorporate by reference: (a) documents produced by a person or body other than the Minister (or reproductions /translations of those documents by the Minister); (b) internal documents; (c) documents produced jointly with another government, and to enable those documents to be incorporated by reference as amended from time to time.
- Addition of an authority for the Minister to order a recall of a radiation emitting device that poses a risk to human health or safety, in the time and manner specified by the Minister.
- Addition of the authority for the Minister to order a person to take measures including, among other things, stopping the manufacture, import, storage, advertisement, transport or sale of a radiation emitting device or a component thereof.
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