Guide to the environmental risk management authorities under the Food and Drugs Act: Overview

Objective

New ministerial authorities under the Food and Drugs Act (FDA) came into force, for therapeutic products, with the passing of the Strengthening Environmental Protection for a Healthier Canada Act (44-1), on June 13, 2023.

This guide sets out principles, policies, considerations and standards that should be followed when we identify situations where it may be appropriate for the Minister of Health (Minister) to take action should an environmental risk be suspected or identified in relation to a therapeutic product.

Specifically, this guide:

helps us apply and implement the authorities fairly, consistently and effectively
explains what triggers the Minister’s ability to use these authorities
explains to what or whom the authorities apply
describes the thresholds that must be met for the Minister to use the authorities
explains the process for enacting orders under these authorities
supports the development of operational tools and processes required to use these authorities and
supports the development of orders and potential future regulations related to these authorities

This guide is an administrative, not a legal, instrument.

Background

The amendments provide the Minister with a number of additional authorities with an overall goal of protecting the environment. These authorities:

incorporate an environmental purpose into the FDA
strengthen the environmental oversight of therapeutic products throughout their lifecycle
expand the Minister’s ability to manage environmental risks resulting from the release of authorized therapeutic products into the environment
enable us to make laws to strengthen the environmental risk assessment and risk management of products regulated under the FDA and
promote confidence in the environmental oversight of therapeutic products by providing transparency, for example, by requiring the Minister to make orders publicly available

The authorities that expanded the Minister’s ability to manage environmental risks came into force immediately. Depending on the severity of the environmental risk that is suspected or identified with respect to an authorized therapeutic product, these authorities allow the Minister to:

order a person or company to provide information that is in the person’s possession, relating to environmental risks
disclose confidential business information (CBI) in certain circumstances
order an authorization holder to change the product’s label or to change or replace its packaging
order a person who sells the product to recall it and
order an authorization holder to compile information or conduct further tests, studies or monitoring

We will bring other amendments into force after we have made supporting environmental risk assessment regulations under the Food and Drug Regulations.

Principles

The FDA sets out the authorities available to the Minister, and the administration of legislation in Canada is subject to generally applicable legal principles. These principles are meant to guide the process by which the laws are administered and enforced. The goal is to ensure that the process is accessible, fair, reasonable, efficient and in accordance with the authorities that have been conferred on the body exercising them.

The following administrative principles serve as a guide for Health Canada when applying these authorities:

Principle 1: The regulator should exercise a statutory authority of decision reasonably and in a procedurally fair manner that is free from bias or the appearance of bias.
Principle 2: The regulator should exercise a statutory authority of decision based on evidence, taking into account only those considerations that are relevant. Decisions should be documented.
Principle 3: The regulator should exercise a statutory authority of decision in a transparent manner. Decisions and reasons for them should be made public and be written in plain language.

Applying the law

When deciding whether to make an order under these authorities, the Minister must determine that the elements of the authority have been met. ln determining, the Minister relies on the recommendations made by departmental officials. These officials analyze the scientific information along with the benefits, risks and uncertainties, including any limitations in methodology, before making recommendations to the Minister.

There are 5 elements of an authority:

what products the authority applies to
who the authority applies to (if applicable)
what the scope of the authority is
who can use the authority
what the threshold or considerations are that need to be met to exercise this authority

The following example for subsection 21.301(1) of the FDA that confers a power on the Minister to require information shows how these elements can be broken down:

“21.‍301(1) If the Minister believes that a therapeutic product may present a serious risk to the environment, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk.”

What products the authority applies to: The authority applies to a “therapeutic product”
Who the authority applies to: The authority applies to “a person”
What the scope of the authority is: The scope of the authority is to provide the Minister with information “that is in the person’s control”
Who can use the authority: “The minister” can use this authority
What the threshold or considerations are that need to be met to exercise this authority: The threshold that needs to be met is when “a therapeutic product may present a serious risk to the environment” and “the information is necessary to determine whether the product presents such a risk”

Scope and application

These authorities apply to therapeutic products. They give the Minister the ability to identify, assess and take action should a direct or indirect environmental risk be suspected or identified in relation to a therapeutic product.

Voluntary action to resolve a problem

Unless circumstances warrant otherwise, a notification will precede a ministerial order so that a person or an authorization holder can voluntarily take steps to resolve a problem. Should the affected person fail to respond to the notification, the Minister can issue an order. For further discussion, refer to “Sufficient notice.”

Openness and transparency

Transparency around regulatory decision-making helps regulated parties and the public better understand how and why decisions are made. This promotes trust in the regulator. We will develop any orders contemplated under these authorities transparently and after consulting with relevant parties.

We will publish all orders along with any relevant supporting scientific evidence and reasoning used to support the decision. This type of information could include, for example:

the reason behind making the order
how the thresholds were met (if applicable) and
information on the therapeutic product subject to the order

Where necessary, we may redact certain information before publishing an order, for example, to protect a person’s privacy or CBI.

Compliance and enforcement of ministerial orders

Ministerial orders are a type of regulation and have force of law. Regulated parties and products included in a ministerial order made under these authorities are subject to:

the compliance and enforcement provisions of the FDA
the compliance and enforcement policies for therapeutic products

Health Canada expects regulated parties to comply with an order made under these authorities, including any conditions set out in an order, and take timely and appropriate action to address non-compliance.

Health Canada will assess and verify incidents of potential non-compliance with an order.

Health Canada uses a variety of compliance and enforcement measures to monitor and verify that regulated parties comply with the requirements.

Learn more:

Health Canada’s compliance and enforcement policy for health products

Sufficient notice

Affected parties may benefit from receiving notice of the Minister’s intention to issue an order so that they have an opportunity to be heard. For the purposes of procedural fairness, a notice would contain the following elements, depending on the circumstances:

a reference to the section of the FDA by which the Minister derives their ability to make the order
the therapeutic product subject to the notice
scientific evidence that relates to the issue that needs to be addressed, such as a summary of the history and facts that the regulator intends to rely on to make the order
the criteria that will be used to determine the threshold has been met, including any relevant findings on important questions of fact and the analysis used to form the basis for the conclusions
the proposed necessary action the party should take to resolve the issue and
a statement that the Minister reserves the right to extend the timeframe given for the authorization holder to take action

In general, we would provide a notice because the orders may adversely impact the regulated persons. However, in urgent or exceptional circumstances, we may not provide a notice.

Definitions and interpretations

The following terms used in this guide are defined from the Food and Drugs Act (FDA) or an interpretation is provided.

Authorization holder

Throughout this guide, an “authorization holder” means the holder of a therapeutic product authorization. Section 2 of the FDA defines a "therapeutic product authorization” as:

“(a) an authorization, including a licence, that

(i) authorizes the conduct of a clinical trial in respect of a therapeutic product and is issued under the regulations, or
(ii) authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product and is issued under subsection 21.92(1) or the regulations or

(b) an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended.”

Confidential business information

Section 2 of the FDA sets out 3 conditions that must be met for information to be considered confidential business information:

“in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information:

(a) that is not publicly available
(b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and
(c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.”

Government

Subsection 21.1(4) of the FDA defines “government” to include any of the following or their institutions:

“(a) a federal government

(b) a corporation named in Schedule III to the Financial Administration Act
(c) a provincial government or a public body established under an act of the legislature of a province
(d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act
(e) a government of a foreign state or of a subdivision of a foreign state or
(f) an international organization of states.”

Imminent risk

The FDA does not contain a definition of “imminent risk”. “Imminent” can be read and interpreted for the purposes of this guide as per its plain language definition, such as “ready to take place” or “close at hand.”

Indirect human health risks

Indirect human health risks are risks from people being exposed to substances indirectly through the environment, for example, via drinking water, outdoor and indoor air, soil and dust.

Minister

In this guide, Minister refers to the Minister of Health. The Minister may designate officials to carry out the various regulatory functions. These designated officials and their superiors, up to and including the Deputy Minister and Minister, become capable of making and issuing orders.

Ministerial order

A ministerial order lays out instructions, decisions, rules or requirements given by the Minister that are authorized by the legislation. Orders made by the Minister will be accompanied by reasoned decisions. To support transparency, orders made by the Minister should clearly communicate the decision and the evidence used to make that decision, so the affected party understands how the result was reached.

Person

Section 2 of the FDA defines a “person” as “an individual or an organization as defined in section 2 of the Criminal Code.” For example, this could include a single person, an individual company, a research institution, a corporation or a therapeutic product authorization holder.

Sell

Section 2 of the FDA defines “sell” to include:

“(a) offer for sale, expose for sale or have in possession for sale or distribute to one or more persons, whether or not the distribution is made for consideration and

(b) lease, offer for lease, expose for lease or have in possession for lease.”

Serious risk to the environment

The FDA does not contain a definition of “serious risk” to allow for flexibility in its application. For further discussion, refer to “Determining risk to the environment.”

Therapeutic product

Section 2 of the FDA defines a "therapeutic product” as “a drug or device, or any combination of drugs and devices.” Therapeutic products include, for example:

biocides
vaccines
medical devices
gene and cell therapies
natural health products
cells, tissues and organs
blood and blood components
prescription and non-prescription human and veterinary drugs

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Date modified:: 2025-03-20

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