Products of Biotechnology

Under the   Canadian Environmental Protection Act, 1999 (CEPA 1999) , Health Canada shares the responsibility with Environment Canada for the risk assessment of new animate products of biotechnology including micro-organisms. Products of biotechnology that do not undergo pre-manufacture assessment for toxicity under other federal legislation such as the   Food and Drugs Act (F&DA) , fall under the purview of CEPA 1999 and must be "notified" accordingly. Under CEPA 1999, both naturally occurring and genetically modified organisms are assessed. Evaluators in the Biotechnology Section of the New Substances Assessment and Control Bureau assess the information submitted by notifiers as prescribed by the  New Substances Notification and Regulations (NSNR) and the  Guidelines for the Notification and Testing of New Substances for organisms and render a decision as to whether or not a substance is "toxic" as defined in CEPA 1999.

The health risk assessment for products of biotechnology considers the following issues:

  • Identification and strain history of the organism.
  • Documented involvement of the organism in adverse human health effects.
  • Relationship to known pathogens.
  • Tests for antibiotic susceptibility.
  • Tests for pathogenicity.
  • Potential to elicit adverse immunological reactions.
  • Estimated number of persons that may be exposed and degree of exposure.

The Biotechnology Section also manages a number of scientific projects to develop tools to assist evaluators in decision-making and ultimately to support a sound, science-based regulatory framework. These projects include the identification of specific groups of potentially notifiable bacteria such as Pseudomonas and Bacillus species, as well as the development of protocols to predict the pathogenic potential of notified substances.

Under Section 74(b) of CEPA 1999, the Minister of Environment and the Minister of Health are also required to conduct screening assessments of all living organisms listed on the Domestic Substances List (DSL) to determine whether they are toxic or capable of becoming toxic as defined under the Act. The Biotechnology Section will be conducting the human health screening assessments of these living organisms. For more information, please visit the  DSL (Organism) screening assessment web page.

For more information on the notification and assessment of products of biotechnology under CEPA 1999, please consult the  New Substances Program jointly administered by Environment Canada and Health Canada.

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