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What are the Environmental Assessment Regulations?

The purpose of these regulations is to put into place an appropriate regulatory regime to assess the potential risks that new substances in products regulated under the Food and Drugs Act may be having on human health and the environment. The objective of the regulations is to ensure that Canadians have access to safe and effective products while protecting the health of Canadians and the environment. These regulations are being built under the Canadian Environmental Protection Act (CEPA), 1999.

What substances will be subject to the Environmental Assessment Regulations?

The regulations will apply to new substances that are regulated under the Food and Drugs Act. This includes drugs, biologics, radio-pharmaceuticals, veterinary drugs, medical devices, natural health products and cosmetics, foods, and food additives.

How are these substances currently being addressed?

Currently, new substances regulated under the Food and Drugs Act are subject to New Substances Notification Regulations under the Canadian Environmental Protection Act, 1999.

When the Environmental Assessment Regulations come into effect, they will replace the New Substances Notification Regulations only with respect to new substances that are used in products regulated under the Food and Drugs Act.

If these substances are already regulated, why are new regulations necessary?

Environment Canada's New Substances Notification Regulations were developed with industrial substances in mind, such as floor cleaners and fire retardants, not substances regulated under the Food and Drugs Act, such as pharmaceuticals and cosmetics.

Some substances regulated under the Food and Drugs Act have unique properties and exposure patterns that require a different approach to environmental assessment than what is currently required under the New Substances Notification Regulations.

The Environmental Assessment Regulations will further strengthen the ability of Health Canada and Environment Canada to protect human and environmental health by allowing Health Canada to better identify and prevent potential risks to human and environmental health caused by the release of Food and Drugs Act substances into the environment.

How will the new regulations differ from what is currently in place?

The new regulations will differ from existing requirements with respect to when companies are required to submit data and the type of data companies are required to submit. The requirements will be specifically tailored to substances used in Food and Drugs Act products, taking into consideration factors such as the substance type, exposure patterns and the volume that is being manufactured, imported or sold.

What consultations have been undertaken with respect to the development of these regulations?

Health Canada has undertaken extensive stakeholder consultations, spanning several years, with various partners and stakeholders to inform the development of these regulations. Input has been sought and received from industry, environmental advocacy groups, consumer groups, health groups/health coalitions, professional associations, and other federal and provincial government departments.

From September 1, 2001, to October 30, 2001, all stakeholders had the opportunity to comment on the Notice of Intent to develop Environmental Assessment Regulations.

Throughout 2002 and 2003, stakeholders were consulted on the context, scope, and factors to be considered by Health Canada in developing regulatory options for Food and Drugs Act substances. Stakeholder feedback from these consultations was incorporated into the Final Issue Identification Paper which was released in July 2003. In June 2005, the Options Analysis Paper was released for review and comment by stakeholders. This paper identifies several critical issues of a proposed new regulatory regime for the environmental assessment of new Food and Drugs Act substances. In 2006, the Options Analysis Paper Feedback Analysis Report was released. This paper provides an analysis and summary of the comments from stakeholders on the regulatory options, the critical issues and their components, and other issues of concern.

Health Canada also established the Environmental Assessment Working Group (EAWG), representing a cross-section of non-government interests and expertise, to provide broad, strategic advice on policy, technical, operational and regulatory issues to Health Canada and Environment Canada. The Working Group has met at least twice per year since it was established in the fall 2006.

Is the consultation process still open?

Yes. When the proposed regulations are published in Canada Gazette I, which is anticipated in 2011, stakeholders will have the opportunity to provide comments on the proposed regulations. A notice will also be published on the Health Canada website informing Canadians when the regulations have been pre-published and the comment period has begun.

What is the current status of the Environmental Assessment Regulations? What are the next steps?

It is anticipated that the proposed Environmental Assessment Regulations will be pre-published for comment in Canada Gazette, Part I (Notices and Proposed Regulations) in 2011.

Is Health Canada looking at any other non-regulatory approaches toward reducing the presence of Food and Drugs Act substances in the environment?

Health Canada's research into the impact of Food and Drugs Act substances on the environment is ongoing. The Best Management Practices Group of Health Canada's Environmental Impact Initiative is currently researching how products regulated under the Food and Drugs Act enter the environment, such as through the disposal of expired or unwanted consumer drugs and other consumer health products.

This group is also researching the potential environmental and human health impacts of these products and existing non-regulatory initiatives that may reduce their release into the environment, such as 'take-back programs' offered by some pharmacies where customers can return unused pharmaceuticals for proper disposal. This research will be used to analyse what additional non-regulatory initiatives or improvements to existing non-regulatory initiatives may be required.

Will Canadians be consulted on these non-regulatory approaches?

Yes. The Best Management Practices Group will be conducting regional multi-stakeholder consultations in 2011 to discuss the research findings and potential areas for further consideration.

Where can I get more information?

For more information on the Environmental Assessment Regulations and the Best Management Practices group, please contact us.

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