New Substances Notification Regulations (Organisms)
SCHEDULE 3(Subsection 3(5) and paragraph 6(c))Information Required in Respect of Micro-organisms for Introduction in an Experimental Field Study
1 The following information in respect of the micro-organism:
(a) its identification and the information substantiating its identification;
(b) its common and superseded names and any synonyms;
(c) its strain history;
(d) a description of any modifications to the micro-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 stability of the changes referred to in subparagraph (iii), and
(v) the nature, source and function of any inserted genetic material;
(e) a description of the methods that can be used to distinguish and detect the micro-organism;
(f) a description of the biological and ecological characteristics of the micro-organism, including
(i) its infectivity, pathogenicity to non-human species, toxicity and toxigenicity,
(ii) the conditions required for, and conditions that limit, its survival, growth and replication,
(iii) its life cycle, if the micro-organism is not indigenous,
(iv) its resistance to antibiotics and tolerance to metals and pesticides, if the micro-organism is not indigenous,
(v) its involvement in biogeochemical cycling, if the micro-organism is not indigenous, and
(vi) the mechanisms of its dispersal and the modes of interaction with any dispersal agents;
(g) a description of the known mode of action in relation to the objective of the experimental field study;
(h) the identification of any patent or any application for a patent, as the case may be;
(i) if the micro-organism is not indigenous, the dispersal by gene transfer of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, including a description of
(i) the genetic basis for pathogenicity to non-human species, toxigenicity and resistance to antibiotics,
(ii) the capability to transfer genes, and
(iii) the conditions that might select for dispersal of traits of pathogenicity to non-human species, toxigenicity and resistance to antibiotics, and whether the conditions are likely to exist at the site of the experimental field study or within the range of dispersal of the micro-organism; and
(j) a description of the geographic distribution of the micro-organism.
2 The following information in respect of the manufacture and importation of the micro-organism:
(a) the identification of trade names and manufacturers, importers and vendors;
(b) the physical state of the formulation;
(c) the concentration of the micro-organism in the formulation;
(d) the identification and concentration of other ingredients and of any contaminants in the formulation;
(e) the viability of the micro-organism in the formulation;
(f) a description of any recommended storage and disposal procedures;
(g) an estimation of the quantity of the micro-organism that will be imported into or manufactured in Canada, as the case may be;
(h) a description of the equipment and methods of manufacture and of quality control and quality assurance procedures;
(i) a description of the location of manufacturing facilities in Canada;
(j) a description of the nature of potential releases of the micro-organism from the manufacturing facilities in Canada or from the facilities to which the micro-organism will be imported, as the case may be, and the procedures to control releases; and
(k) a description of the procedures for the treatment and disposal of wastes containing the micro-organism from the manufacturing facilities in Canada.
3 The following information in respect of the site of the experimental field study:
(a) its location and a map;
(b) its size;
(c) the distance to populated areas;
(d) the distance to any protected areas;
(e) a description of the geological landscape at the site and surrounding the site;
(f) a description of the biological diversity found at the site and surrounding the site, including
(i) the identification of the endangered or threatened species, and
(ii) if infectivity, pathogenicity to non-human species, toxicity and toxigenicity have been identified in subparagraph 1(f)(i), the identification of the receptor species;
(g) a comparison of the natural habitat of the micro-organism to the habitat at the site of the experimental field study, and the nature of the selection that may operate on the micro-organism at that site; and
(h) if the micro-organism is indigenous, data to demonstrate that it is indigenous.
4 The following information in respect of the experimental field study:
(a) its objectives;
(b) the history of use of the micro-organism;
(c) its start date and duration;
(d) a description of the procedures for transporting the micro-organism to and from the site of the experimental field study;
(e) a description of the procedures and design for the experimental field study, including
(i) the method of application of the micro-organism,
(ii) the quantity, frequency and duration of application of the micro-organism, and
(iii) any activities associated with the experimental field study;
(f) a description of any procedures for monitoring the micro-organism and its ecological effects at the site of the experimental field study, during and after the experimental field study;
(g) a description of the security measures at the site of the experimental field study;
(h) a description of any contingency plans in the event of an accidental release;
(i) a description of any recommended procedures for terminating the experimental field study; and
(j) a description of any confinement procedures and biosafety conditions for the micro-organism at the site of the experimental field study, and a description of their effectiveness.
5 The following information in respect of the environmental fate of the micro-organism:
(a) a description of habitats where the micro-organism may persist or proliferate;
(b) the estimated quantities of the micro-organism in the air, water and soil at the points of introduction and the estimated population trends; and
(c) any other information on the environmental fate of the micro-organism.
6 The following information in respect of the ecological effects of the micro-organism:
(a) the involvement of the micro-organism in adverse ecological effects; and
(b) the potential of the micro-organism to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity.
7 The following information in respect of the human health effects of the micro-organism:
(a) any documented involvement of the micro-organism in adverse human health effects and a description of the characteristics of the micro-organism that distinguish it from known pathogens;
(b) the data from tests of antibiotic susceptibility; and
(c) the estimated number of persons who may become exposed and the degree of their exposure to the micro-organism.
8 All other information and test data in respect of the micro-organism that are relevant to identifying hazards to the environment and human health and that are in the person’s possession or to which the person ought reasonably to have access.
9 The identification of other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the micro-organism, and the purpose of that notification.
10 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.
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