6. Animate products of biotechnology (Part 6)
The act establishes an assessment process for living organisms that are new animate products of biotechnology, which mirrors provisions in Part 5 of Canadian Environmental Protection Act, 1999 (CEPA 1999) respecting new substances that are chemicals or polymers. Part 5 also includes a provision under 74(b) that requires that all living organisms on the Domestic Substances List (DSL) (about 45 micro-organisms) undergo a screening assessment.
In 2008-2009, through the New Substances Program, the Ministers jointly managed the screening assessment process for micro-organisms listed on the DSL. Guidelines were finalized and will be published on the website when approved. The guidelines include a risk assessment framework guideline, a prioritization guideline for DSL living organisms and a guideline for the external review of the draft screening assessment reports.
The Technical Expert Group continued to provide advice on the process and to validate the scientific basis of screening assessments and their conclusions. The Technical Expert Group is composed of independent scientific experts from academia, industry, public advocacy groups and other federal government departments. In 2008-2009, an annual report highlighting the Technical Expert Group's recommendations and the Government's response was also produced.
Work continued on planning and refining the approach for an information gathering notice under CEPA 1999 (section 71) to obtain basic information on the manufacture, import and use of DSL micro-organisms. The Technical Expert Group provided valuable comments on the information to be captured through this activity.
During 2008-2009, three notifications were received pursuant to the New Substances Notification Regulations (Organisms) for new animate products of biotechnology. Significant New Activity Notices were published for two of these substances.
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