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

This annex sets out the considerations for determining whether an authorized therapeutic product presents a risk to the environment. Determining the level of environmental risks or harms associated with an authorized therapeutic product is complex. This is determined on a case-by-case basis when new or additional information becomes available after a therapeutic product has been authorized.

This information may point to a potential or actual environmental concern or indicate that the environmental risks of a therapeutic product may have changed since the original authorization. This information can come from a number of sources, for example:

• another therapeutic product submission or application pathway
• new or additional scientific information, research or studies that are submitted or becomes available (for example, information submitted as part of terms and conditions placed on a market authorization, another order made under the Food and Drugs Act, reports published in medical or scientific literature, or information received from another government, regulatory agency, department)
• a scientific assessment conducted, or risk management measures implemented, under another act or jurisdiction at any stage of a therapeutic product’s lifecycle (for example, an assessment conducted or risk management measure implemented under the Canadian Environmental Protection Act, 1999, the Pest Control Products Act, or by another program or international regulatory agency)
• an inspection conducted by Health Canada (for example, a good manufacturing practice inspection) or by another trusted regulator (for example, another department or program, government, jurisdiction) or
• other international regulatory agencies

We will evaluate these or other relevant sources of information to determine whether the authorized therapeutic product presents or may present a risk to the environment. Following the evaluation of the information, if there is a reason to believe that the product presents or may present a risk to the environment, the Minister may choose to implement the environmental risk management authorities.

The Minister may consider a therapeutic product to present a risk to the environment if its release into the environment could result in:

• an indirect human health risk to people in Canada
• an immediate or long-term harmful effect on the environment or its biological diversity and/or
• a danger to the environment on which life depends

Determining if a therapeutic product or substances contained within it presents or may present a risk to the environment should be based on a scientific evaluation. The following type of information should be considered in the evaluation:

• how the product or substance behaves in the environment
• the specific characteristics of the product or substance (for example, its persistence, bioaccumulation)
• the hazardous properties of the product or substance and the potential adverse effects on the environment or indirectly to human health (for example, toxicity to aquatic organisms, cancer-causing properties) and
• the nature and extent of exposure to the environment or indirectly to people in Canada resulting from the release of the product or substance (for example, sources, quantity of release, behaviour)

We will make each determination of risk using a weight of evidence approach based on information available at the time of the assessment. However, the determination could change if additional information becomes available.

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