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ARCHIVED - CEPA Annual Report for Period April 2003 to March 2004

6. Animate Products of Biotechnology

The Act establishes an assessment process for living organisms that are new animate products of biotechnology that mirrors provisions in Part 5 of CEPA 1999 respecting new substances that are chemicals or polymers. Animate products of biotechnology may pose several potential risks to the environment, including possible impacts on natural biodiversity. They may introduce toxins, interfere with naturally occurring plants and animals and harm natural genetic diversity.

Living organisms that are not on the Domestic Substances List are considered to be new. These cannot be used, manufactured or imported until:

  • the Minister has been notified;
  • relevant information needed for an assessment has been provided by the applicant; and
  • the period for assessing the information has expired.

When the assessment process identifies a living organism that may pose a risk to human health or the environment, the Act empowers Environment Canada to intervene by either requiring a risk management measure placing restrictions or prohibiting the substance from import or manufacture in Canada.

When Environment Canada and Health Canada suspect that a significant new activity in relation to a living organism that had been previously assessed and found not to be toxic may result in the organism becoming toxic, a Significant New Activity Notice is issued to ensure that adequate additional information is provided to the Minister by the notifier or any other proponent who wishes to manufacture, import or use the organism for activities not specified by the notice. The additional information allows Environment Canada and Health Canada to assess the potential environmental and human health risks associated with the new activities.

CEPA 1999 requirements apply to new living organisms that are manufactured or imported unless other applicable acts and regulations provide for notice and assessment and are specifically identified on Schedule 4 of the Act.

6.1 Risk Assessment and Management

In 2003-04, the New Substances Program received eight new substance notifications and two Significant New Activity notifications. Significant New Activity Notices were published for three of these notifications.

6.2 International Actions

6.2.1 Cartagena Protocol on Biosafety to the Convention on Biological Diversity

The Protocol was signed by Canada in April 2001; however, it has yet to be ratified. It promotes the safe transfer, handling and use of living modified organisms that may have adverse effects on biodiversity, taking into account human health with a specific focus on transboundary movement.

The Protocol establishes a Biosafety Clearinghouse to facilitate the exchange of information and to assist Parties to implement the protocol. Although Canada is not a Party to the protocol and therefore under no legal obligation to provide information, Canada intends to do so to the fullest extent possible. A gap analysis has been done on Canada's current information holdings and the information requirements of the protocol. Efforts are under way to generate relevant information for the clearinghouse on the Canadian regulatory framework and regulatory decisions taken regarding living modified organisms.

6.2.2 Working Group on Harmonization of Regulatory Oversight in Biotechnology

This working group under the Organisation for Economic Co-operation and Development ensures that environmental, human health and safety aspects of products of biotechnology are properly evaluated while avoiding non-tariff trade barriers to these products. The working group met for its 14th session in November 2003. Delegates, including Canada, provided updates to member states on regulatory developments in their respective countries. Reports were also received describing progress made in the development of consensus documents (microorganisms and plants), on harmonization of molecular characterization information, on parameters for environmental risk/safety assessment (of plants) and on transgenic fish.