Guide to the precision regulating authorities under the Food and Drugs Act: Exemption authority
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Section 30.05
The following subsections of the Food and Drugs Act (FDA) set out the exemption authority.
Subsection 30.05(1), the authority to establish exemptions for foods and therapeutic products:
"Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, on any conditions that the Minister considers necessary, exempt (other than in relation to cosmetics) a class of foods, therapeutic products, persons or activities from the application of all or any of the provisions of Part I, section 37 or the regulations."
Subsection 30.05(1.1), the authority to establish exemptions for a person:
"Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, on any conditions that the Minister considers necessary, exempt a person (or any food, therapeutic product or activity, or any class of foods, therapeutic products or activities, in relation to a person) from the application of all or any of the provisions of Part I, section 37 or the regulations. The order cannot relate to cosmetics."
Note: The authority to exempt a single person will come into force at a later date.
Subsection 30.05(2), the preconditions required before making an order:
"The Minister may make an order under subsection (1) or (1.1) only if the Minister believes on reasonable grounds that:
- (a) it is necessary for a health or safety purpose or is otherwise in the public interest and
- (b) having regard to its benefits and conditions, it is unlikely to result in:
- (i) unacceptable health, safety or, if applicable, environmental risks or
- (ii) an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks"
Scope of the exemption authority
Orders under the class exemption authority
There are 2 types of orders under this authority:
- class orders
- person-specific orders
The exemption authority under subsection 30.05(1) of the FDA applies to a:
- class of foods
- class of therapeutic products
- class of persons or
- class of activities such as manufacturing, packaging or selling
Exemption orders cannot be made for cosmetics.
For class orders, the class of foods, therapeutic products, persons or activities, as applicable, depends on the situation at hand and is determined when the order is being developed.
Only the Minister may make, amend or revoke a class exemption order under section 30.05(1) of the FDA. These activities cannot be delegated to officials.
The class exemption authority allows the Minister to make an order exempting a class of foods, therapeutic products, persons or activities from any of the provisions under Part I or section 37 of Part II of the FDA or its regulations. The Minister may set out conditions in the order that are considered necessary.
The person-specific exemption authority under subsection 30.05(1.1) of the FDA will come into force at a later date.
Legislative preconditions
The Minister can only use this authority if there are reasonable grounds to believe the following:
- (a) The order is necessary for a health or safety purpose or is otherwise in the public interest and
- (b) Having regard to the benefits and conditions of the order, the exemption is unlikely to result in:
- unacceptable health, safety or, if applicable, environmental risks or
- an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks
These legislative preconditions, set out in subsection 30.05(2) of the FDA, are meant to be flexible enough to accommodate situations where tailoring the regulatory approach is necessary for health or safety or is in the public interest. This may include, for example, situations where the rights protected by the Canadian Charter of Rights and Freedoms may be engaged.
Process for making a class exemption order
If we determine that a class exemption order under these authorities is the best option to address the issue at hand, officials must ensure that the legislative preconditions have been met. They will also conduct the necessary analysis to support the order being developed.
Consultation
We will consult with relevant stakeholders and health system partners during the development of a class exemption order. These consultations may take different forms depending on such things as the number of stakeholders and partners who are affected or the urgency of the situation.
Publication
Class exemption orders are subject to both the Statutory Instruments Act and the Cabinet Directive on Regulation and are published in the Canada Gazette, Part II.
A class exemption order may include:
- the class of foods, therapeutic products, persons or activities subject to the order, as applicable
- the specific provisions of the FDA or regulations being exempted and
- any applicable conditions
Where necessary, supporting information such as guidance or procedures will be developed and published.
After a class exemption order is made
Once an order is made, officials will assess over time whether it should remain or be updated, repealed or incorporated into our regulations of general application.
Refer to the Definitions and interpretations page for definitions on confidential business information, food, Minister, Ministerial order, person and therapeutic product.
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