6. Animate products of biotechnology
Part 6 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. Inanimate products of biotechnology will continue to be dealt with as "substances" under Part 5.
Living organisms that are not on the 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;
- the prescribed fee has been paid; and
- the period for assessing the information has expired.
Since the start of the program in 1997, 88 notifications have been received, and 34 have already been taken through the full assessment procedure. During 2000-01, three additional assessments were completed, with no control actions necessary. A significant new activity notice was issued for one of these substances. For the other 51 notifications, information submitted by companies was incomplete and could not be processed.
The Cartagena Protocol on Biosafety under the Convention on Biological Diversity was negotiated in January 2000. 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 before agreeing to the import of such organisms into their territory. (Canada signed the Protocol in April 2001.)