Guide to the environmental risk management authorities under the Food and Drugs Act: Authority to compile information or require tests, studies or monitoring

Section 21.33

The following section of the Food and Drugs Act (FDA) sets out the authority to compile information or require tests, studies or monitoring.

Subsection 21.33, authority to compile information or require tests, studies or monitoring:

“Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on the environment, order the holder of a therapeutic product authorization to

(a) compile information or conduct tests, studies or monitoring in respect of the therapeutic product and
(b) provide the Minister with the information or the results of the tests, studies or monitoring.”

Authority to compile information or require tests, studies or monitoring

Scope

Section 21.33 of the FDA applies to therapeutic products only.

An authorization holder of 1 or more of the following therapeutic product authorizations can be subject to this authority:

a drug identification number (DIN) that has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations
a drug establishment licence (DEL) that has been issued under subsection C.01A.008(1) of the Food and Drug Regulations
a notice of compliance (NOC) that has been issued under section C.08.004 of the Food and Drug Regulations
a medical device licence that has been issued under the Medical Devices Regulations
a medical device establishment licence that has been issued under the Medical Devices Regulations
a natural health product licence that has been issued under the Natural Health Products Regulations
a natural health product site licence that has been issued under the Natural Health Products Regulations

This authority allows the Minister to make a ministerial order requiring an authorization holder to compile information, conduct tests or studies, or monitoring that the Minister considers necessary regarding the therapeutic product’s effect on the environment or to address uncertainties with the environmental risk.

About the threshold that needs to be met before using this authority

The Minister can only use this authority to obtain more information about a therapeutic product’s effects on the environment where they believe that:

there are uncertainties relating to the environmental risks associated with a therapeutic product
the authorization holder is unable to provide the Minister with information sufficient to manage those uncertainties
the applicable requirements in the regulations do not allow for sufficient information to be obtained to manage the uncertainties or
the information provided by the authorization holder with respect to environmental safety is determined to be:
- invalid
- deficient or
- inadequate to assess the environmental risks associated with a therapeutic product

The minister’s use of this authority should be reserved for instances where a lack of knowledge about a therapeutic product could negatively impact the environment.

In some cases, environmental risk may only pose an unacceptable risk to the environment if the amount of a therapeutic product in the environment exceeds certain levels. For example, some drugs may persist and accumulate in the environment and harmful effects may only be observed once the amounts accumulated have exceeded certain levels. In this case, the Minister may use this authority to request new information in the form of environmental monitoring data. Environmental monitoring allows the Minister to determine when levels could exceed safe limits and take action to mitigate any environmental risks as soon as possible.

Process for making an order to compile information or require tests, studies or monitoring

Before making an order under section 21.33 of the FDA, the minister, with support from officials, must ensure the threshold has been met and that the order meets the policy objectives. They will conduct scientific, policy and regulatory analyses to ensure these criteria are met.

Notification and opportunity to respond

When we are considering an order under this authority, we will consult, when applicable, with the relevant parties. In addition, in general, before making an order, we would provide prior notification to the authorization holder subject to the order. However, in urgent or exceptional circumstances, we may not provide a notification.

The notification would:

inform the authorization holder that the Minister believes additional information about a therapeutic product is necessary to determine the therapeutic product’s effect on the environment and address uncertainties associated with its environmental risk
set out the facts and the relevant criteria used to form the basis of this belief and
give the authorization holder the opportunity to voluntarily provide the additional information

Unless circumstances warrant otherwise, the notification would also provide the affected authorization holder with a reasonable opportunity to:

correct an error in fact
dispute the proposed exercise of the authority or
voluntarily comply with the measures outlined in the notification

The notification may also specify the timeframe in which the authorization holder must respond.

The Minister can issue an order whether they have previously notified the authorization holder or not. For further discussion, refer to “Sufficient notice.”

Development of the order

An order made under section 21.33 of the FDA is not a statutory instrument as defined in the Statutory Instruments Act. Therefore, the Minister may delegate the making, amending or revoking of an order to officials, as appropriate.

If we determine that an order under these authorities is the best option to address the issue, officials will conduct the necessary analysis to support its development.

We will consult relevant stakeholders during the development of the order. These consultations may take different forms depending, for example, on the number of stakeholders who are affected or the urgency of the situation.

An order made under section 21.33 of the FDA to an authorization holder would include the following:

the name of the authorization holder or authorization holders it applies to
the legislative authority being relied on
the name of the therapeutic product and/or relevant authorization that is subject to the order including, for example, any relevant details such as the:
- lot number
- manufacturing site
a description of the uncertainties and the activities ordered by the Minister intended to resolve them, if applicable
the timeframe for responding to the order and providing the Minister with the results of the activity and
the consequences of contravening the order

We may develop supporting regulations at a later date.

Publication

In accordance with subsection 21.4(2) of the FDA, the order has to be made public. Where necessary, we may redact certain information before publishing an order, for example, to protect confidential business information.

We will also make supporting information public. This will include the reason for making the order as well as an explanation of the basis for the decision and how it was reached. Supporting information may include:

a narrative and chronological review of the facts
the scientific evidence or other new evidence considered
any findings on important questions of fact and the accompanying analysis applying the facts to the law
any relevant criteria considered as part of the threshold determination and
an explanation of how the evidence satisfies the threshold

Steps the Minister can take after examining the information provided under the order

We will evaluate the information obtained under section 21.33 of the FDA to determine the therapeutic product’s effects on the environment. Following the evaluation of the information, we may choose to make the results of the examination public.

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2025-03-20

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