6. Animate products of biotechnology new to Canada

The Canadian Environmental Protection Act, 1999 (CEPA 1999) 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. Inanimate products of biotechnology will continue to be dealt with as “substances” under Part 5.

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.

CEPA 1999 requirements apply to new living organisms that are manufactured or imported unless other applicable Acts provide for notice and assessment and are specifically identified on Schedule 4 of the act (see Table 6). The act provides the means to recognize equivalent assessment processes under other federal statutes and regulations. New living organisms regulated under those statutes can be exempt from CEPA 1999 if they provide for notification and assessment prior to import, manufacture, or sale. The Governor-in-Council determines, by order, which federal acts and regulations meet these criteria and lists them specifically in Schedule 4 of the act.

In 2002-03, five new substance notifications and one significant new activity notification were received. 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 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. No control actions were necessary during 2002-03. A number of pre-notification consultations were conducted with several potential notifiers to deal with regulatory issues involving microorganisms and other organisms, with specific emphasis on the necessary test data to determine the substance’s potential effects on terrestrial and aquatic plant, invertebrate and vertebrate species.

Environment Canada undertakes research in support of our regulatory function, in particular the biotechnology portion of the New Substances Notification Regulations. Specifically, the research focused on advances in microarray technology that may be used for risk assessment purposes for identifying environmental isolates and also as a potential tool for verifying compliance. In addition, the program supported research that may generate standard methodologies for testing the survival and persistence of microorganisms in the environment (see Section 3.2.2).

Key international activities in 2002-03 included:

• Cartagena Protocol on Biosafety to the Convention on Biological Diversity -- The Protocol was signed by Canada in April 2001. It addresses the safe transfer, handling, and use of living modified organisms (LMOs) that may have adverse effects on biodiversity, taking into account human health, with a specific focus on transboundary movement. The Protocol also establishes a Biosafety Clearinghouse to facilitate information exchange. Cross-Canada consultations were held in September 2002 on whether or not the Government of Canada should ratify the Protocol. Over 300 organizations were invited to participate and were provided with an opportunity to comment on the proposed Living Modified Organisms Regulations under CEPA 1999.

  The proposed Living Modified Organisms Regulations, which were published in the Canada Gazette, Part I, on September 28, 2002, would provide Canada with the national legal measures to support ratification of the Protocol by implementing those regulatory requirements not currently covered under Canadian law. The Living Modified Organisms Regulations under CEPA 1999 would require Canadian exporters to provide documentation to accompany all shipments of LMOs as well as information to allow importing Parties to make decisions regarding first-time imports of LMOs for intentional exposure to the environment.

• OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology -- The working group ensures that environmental, human health, and safety aspects of products of biotechnology are properly evaluated while avoiding non-tariff trade barriers to these products. There were two meetings of the working group in 2002-03. A first draft of the Guidance Document on Detection of Microorganisms in the Environment was presented to the working group in February 2003.