6. Animate Products of Biotechnology (Part 6)

• 6.1 Existing Animate Products of Biotechnology
• 6.2 New Animate Products of Biotechnology

The Act establishes an assessment process for living organisms that are new animate products of biotechnology, which mirrors provisions in Part 5 of CEPA 1999 respecting new substances that are chemicals or polymers. Part 5 also includes a provision under 74(b) requiring that all living organisms on the DSL (about 45 micro-organisms) undergo a screening assessment.

In 2009-2010, Environment Canada and Health Canada jointly developed the screening assessment process for micro-organisms listed on the DSL. The first screening assessment report (Pseudomonas aeruginosa – three strains) was drafted, testing the validity of the risk assessment framework guidance document finalized in 2008-2009, and underwent external scientific review. A second screening assessment report (Bacillus cereus – one strain) was also drafted.

The Technical Expert Group, composed of independent scientific experts from academia, industry, public advocacy groups and other federal government departments, continued providing advice on the process and validating the scientific basis of screening assessments and their conclusions. On October 3, 2009, an information-gathering notice under CEPA 1999 (section 71) was published to obtain basic information on the manufacture, import and use of DSL micro-organisms.

During 2009-2010, 13 notifications were received pursuant to the New Substances Notification Regulations (Organisms) for new animate products of biotechnology, including the first notification in Canada of a genetically modified livestock animal. Significant New Activity Notices were published for two of these organisms: Sus scrofa, and Actinosynnema pretiosum.