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Canadian Environmental Protection Act, 1999 Annual Report for April 2011 to March 2012


6 Animate Products of Biotechnology (Part 6)

CEPA 1999 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 “existing” micro-organisms) undergo a screening assessment to determine whether the living organism is toxic or capable of becoming toxic.

6.1 Existing Animate Products of Biotechnology

Environment Canada and Health Canada jointly developed the screening assessment process for micro-organisms listed on the DSL in 2008. In 2011–2012, the first draft screening assessment report (Pseudomonas aeruginosa – three strains on the DSL) was published on July 2, 2011, in the Canada Gazette, Part I for public comment. No comments were received. Final publication is scheduled to be in 2012. A Significant New Activity (SNAc) has been proposed for these three DSL substances (strains). Two additional draft screening assessment reports (Bacillus cereus and Pseudomonas fluorescens) were also prepared and are scheduled to be published in 2012. Work continues on the remaining screening assessments for several other DSL micro-organisms of high priority. In addition, a rapid screening approach has been developed for the lower priority DSL micro-organisms. Publication for public comment for eight of these is planned for 2012–2013. 

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.

6.2 New Animate Products of Biotechnology

During 2011–2012, 29 notifications were received pursuant to the New Substances Notification Regulations (Organisms) for new animate products of biotechnology. In addition, there were nine preliminary assessments of information for prospective regulatory clients. One of the living organisms assessed under the regulations in 2011–2012 was the subject of a Significant New Activity Notice. 

Environment Canada and Health Canada biotechnology sections initiated assessment of DSL and In Commerce List organisms.

Substances that had been previously classified for carcinogenicity, mutagenicity, reproductive toxicity or developmental toxicity by international agencies were identified as part of the ongoing exercise to identify priorities for risk assessment.

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