Other applications could involve the use of organisms other than micro-organisms. The Government of Canada has an overall regulatory policy whereby products of biotechnology are controlled under appropriate federal legislation. Under CEPA, Health Canada and Environment Canada evaluate new biotechnology products for risks to human health or the environment. The Departments then decide whether or not new biotechnology products may be manufactured in or imported into Canada, and whether controls may be warranted or additional testing required. In order to address the differences between living organisms and the other substances like chemicals, the new CEPA has a separate section to specifically assess new biotechnology products which are living organisms.
Assessment occurs before manufacture or importation.
This requires manufacturers and importers to identify the organism and describe its characteristics as well as the exposure of the environment or humans. As well, specific tests will be necessary to ensure that the organism does not affect human health. As with new chemical substances, Health Canada, together with Environment Canada, carefully assesses the information, and determines what controls or further testing are necessary. There are 23,000 substances in Canada that need to be examined for their impact on the environment and human health. The CEPA Priority Substances Assessment Program continues to be the method used to focus on those chemicals and other substances deemed to require an in-depth assessment of risks to the environment and human health.