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. Paragraph 74(b) requires that all living organisms on the DSL (about 68 micro-organisms) undergo a screening assessment to determine whether the living organism is toxic or capable of becoming toxic.

In 2010–2011, Environment Canada and Health Canada jointly developed the screening assessment process for microorganisms listed on the DSL. The first screening assessment report (Pseudomonas aeruginosa – three strains) was prepared and finalized in 2010, with publication scheduled for July 2, 2011. Two additional screening assessment reports (Bacillus sp. and Pseudomonas fluorescens) were also drafted and reviewed by external scientific experts. Their publication is planned for 2011–2012. Initial drafting of several other DSL microorganism screening assessment reports also began in 2010–2011.

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.

During 2010–2011, 16 notifications were received pursuant to the New Substances Notification Regulations (Organisms) for new animate products of biotechnology. In addition, there were eight preliminary assessments of information for prospective regulatory clients. None of the living organisms assessed under the regulations in 2010–2011 were the subject of a Significant New Activity Notice.

In June 2010, Health Canada, in collaboration with Environment Canada, organized and conducted a multi-stakeholder workshop meeting to solicit feedback from stakeholders on proposed amendments to the portion of the regulations dealing with “higher organisms” of the New Substances Notification Regulations (Organisms). Approximately 40 participants from different stakeholder groups (industry, academia, government, non-governmental organizations) reviewed, discussed and provided feedback and recommendations on the latest amendment proposals. This was the third and final multi-stakeholder consultation, building on feedback received from stakeholders in workshops conducted in 2006 and 2007. Drafting of the amended regulations will continue in 2011.