6. Animate products of biotechnology

The act establishes an assessment process for new animate products of biotechnology (such as living organisms) that mirrors provisions in Part 5 respecting new substances that are chemicals. Animate products of biotechnology pose several potential risks to the environment, particularly to 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 (DSL) 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.

Since the start of the program in 1997, 119 notifications have been received, and 32 have already been taken through the full assessment procedure. A significant new activity notice was issued for one of these substances. For 70 notifications, information submitted by companies was incomplete and could not be processed; 13 notifications were withdrawn by the company, and one notification was on hold. In 2001-02, seven notifications were received. One was taken through the assessment process, one was paused, two were on hold, and three were incomplete and returned to the company. No control actions were necessary during 2001-02. As well, a number of consultations were conducted with several potential notifiers to deal with regulatory issues involved in the pre-notification of aquatic and terrestrial plant species and transgenic cows and pigs.

Key international activities related to biotechnology in 2001-02 included:

• Cartagena Protocol on Biosafety to the Convention on Biological Diversity - The Cartagena Protocol on Biosafety under the Convention on Biological Diversity was negotiated in January 2000 and signed by Canada in April 2001. It aims to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. It establishes an advance informed agreement procedure for ensuring that countries are provided with the information necessary to make informed decisions on environmental release before agreeing to the import of such organisms into their territory. Canada is considering whether to ratify the Biosafety Protocol, and the government will consult with Canadians on this specific question in September 2002. (Proposed regulations under CEPA 1999 that would enable ratification to take place, should that decision be taken, were published on August 29, 2002.)
• Organisation for Economic Co-operation and Development (OECD) harmonization of regulatory oversight in biotechnology - An OECD Working Group will ensure that environmental, human health, and safety aspects are properly evaluated while avoiding non-tariff trade barriers to products of biotechnology. Representatives of Health Canada and Environment Canada, as well as the Canadian Food Inspection Agency form Canada's delegation to the Working Group. There were two meetings of the working group in 2001-02. Results included a final Guidance Document on creating a unique identifier for transgenic plants, progress on a consensus document on the use of taxonomy in the risk assessment of microorganisms, and a consensus document on detection methods.
• OECD Working Group on Microorganisms - Health Canada plays a prominent role in the OECD Sub-Working Group on Micro-organisms. In 2001-02, Health Canada and the U.S. Environmental Protection Agency co-wrote a Guidance Document on the Use of Taxonomy in the Risk Assessment of Micro-organisms: Bacteria, which is near publication. Health Canada and the Netherlands will also co-write a Guidance Document on theHealth Effects of Microorganisms.