New Substances Notification Regulations (Organisms) (SOR/2005-248)

1 The following information in respect of the organism:

• (a) the identification, or current taxonomic name to the species or subspecies level, strain, common names, trade name and any synonyms;

• (b) its strain history;

• (c) a description of any modifications to the organism, including

  • (i) the purpose of the modifications,

  • (ii) the methods and steps taken to make the modifications,

  • (iii) the phenotypic and genotypic changes that resulted from the steps referred to in subparagraph (ii),

  • (iv) the genetic stability of the changes referred to in subparagraph (iii), and

  • (v) the nature, source and function of any introduced genetic material;

• (d) a description of the methods that can be used to distinguish and detect the organism;

• (e) a description of the biological and ecological characteristics of the organism, including

  • (i) its life cycle,

  • (ii) its reproductive biology, including species with which the organism could interbreed in Canada,

  • (iii) its involvement in adverse ecological effects, including pathogenicity, toxicity and invasiveness,

  • (iv) a description of the geographic distribution and habitat of the organism,

  • (v) the potential for dispersal of its traits by gene transfer,

  • (vi) the locations and situations where the organism has caused adverse ecological effects,

  • (vii) its involvement in biogeochemical cycling,

  • (viii) its interactions with other organisms in the environment,

  • (ix) the conditions required for its survival, growth, reproduction and overwintering,

  • (x) its capability to act as a vector for agents involved in adverse effects, and

  • (xi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents; and

• (f) the identification of any patent or other rights, or any application for a patent or other rights, as the case may be.

2 The following information in respect of the manufacture and importation of the organism:

• (a) the identification of manufacturers, importers and vendors;

• (b) a description of the locations of manufacture in Canada;

• (c) a description of the product containing the organism;

• (d) a description of any recommended procedures for the storage and disposal of the organism;

• (e) an estimation of the quantity of the organism that will be imported into or manufactured in Canada, as the case may be; and

• (f) a description of the methods of manufacture and of quality control and quality assurance procedures.

3 The following information in respect of the introduction of the organism:

• (a) the history of its use;

• (b) the intended and potential uses of the organism, and the potential locations of introduction;

• (c) a description of the mode of action in relation to the intended use; and

• (d) a description of the procedures for the introduction of the organism, including

  • (i) the method and rate of its introduction,

  • (ii) any activities associated with its introduction,

  • (iii) any recommended procedures for the storage and handling of any surplus organism,

  • (iv) any contingency plans in the event of an accidental release and any reproductive isolation measures, and

  • (v) its resistance to control agents;

• (e) a description of any recommended procedures for terminating the introduction of the organism; and

• (f) a description of the procedures for the disposal of remaining biomass and residues of the organism.

4 The following information in respect of the environmental fate of the organism:

• (a) the estimated quantities of the organism in the environment and the estimated population trends;

• (b) a description of habitats where the organism may persist or proliferate; and

• (c) the identification of the species that are likely to be exposed to the organism and other species that are likely to be affected by it.

5 The following information in respect of the ecological effects of the organism:

• (a) the data from a test conducted to determine its pathogenicity, toxicity or invasiveness;

• (b) the ecological effects of organism residues; and

• (c) the potential of the organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity.

6 The potential for the organism to be involved in adverse human health effects, and the most likely route of human exposure to the organism.

7 All other information and test data in respect of the organism that permit the identification of hazards to the environment and human health and that are in the person’s possession or to which the person may reasonably be expected to have access.

8 The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the organism, and the purpose of that notification.

9 A description or specification of the test procedures followed in developing the test data, including the test methods, reference substances and quality control and quality assurance procedures.