Guide to the environmental risk management authorities under the Food and Drugs Act: Key considerations for managing risks to the environment

This annex sets out the considerations that factor into selecting the most appropriate approach for managing risks to the environment from therapeutic products under the Food and Drugs Act (FDA).

Which authorities under the FDA will be used to manage a risk to the environment will depend on an analysis of environmental, health, economic and social considerations at the time the decision is made. Each consideration may have a different influence or “weight” in determining which risk management authority is most appropriate to address a risk to the environment. If the situation changes or significant new information becomes available after selecting the approach to risk management, then the approach can be updated accordingly.

The following is a non-exhaustive list of elements that the Minister may consider when selecting an approach to environmental risk management for a therapeutic product:

• current use and human or animal benefits (for example, human or veterinary use, medical benefits, and needs met)
• environmental and risk management objectives (for example, desired environmental state and expected outcome of the risk management measure)
• impacts to populations (for example, those with a greater need for access to the product, multiple medical conditions or serious, life-threatening, unique or severely debilitating conditions with limited alternatives, disproportionately impacted populations)
• availability of viable environmentally safe alternative treatments (for example, using a similar product to treat or prevent certain health conditions or improving the health of animals through husbandry practices)
• status of risk assessment and risk management in Canada or in other jurisdictions (for example, whether the substance or similar substances have previously been assessed for environmental risks and if regulatory or non-regulatory risk management actions have already been taken or are going to be taken under another federal act or by provincial, territorial, municipal governments in Canada or by an international jurisdiction)
• potential impacts to industry, consumers, health care professionals if the environmental risk management authorities are used (for example, economic impacts, administrative burden, availability and vulnerability to shortages)
• suitability of using these environmental risk management authorities to manage the environmental risks (for example, ability to address the risk without significantly impacting availability of the product, costs, administrative burden)

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