Health of Animals Regulations (C.R.C., c. 296)

120.2 (1) In this section, “organism” includes a part or product of an organism.

(2) Sections 120.3 to 120.6 do not apply in respect of

• (a) a veterinary biologic

  • (i) in respect of which a product licence has been issued, or

  • (ii) that contains only organisms that are

    • (A) the same as organisms contained in a veterinary biologic referred to in subparagraph (i), or

    • (B) of a species that is substantially equivalent to a species of organisms contained in a veterinary biologic referred to in subparagraph (i), in terms of pathogenicity, host specificity, potential impact on non-target organisms, on biodiversity and on biogeochemical cycles, mode of action, persistence and dispersal in the environment and gene flow; and

• (b) the release of a veterinary biologic, that contains organisms, under containment or in accordance with confinement procedures in a manner that prevents the dissemination of any genetic material from the veterinary biologic into the environment.

120.3 (1) Subject to subsection (2), no person shall release a veterinary biologic unless the person

• (a) submits an application for a permit for the proposed release to the Minister, accompanied by sufficient information, including the information referred to in section 120.4, to enable the Minister to determine whether the proposed release is

  • (i) unlikely to result in the introduction into Canada or the spread within Canada of any vector, disease or toxic substance, and

  • (ii) unlikely to pose a risk of harm to the environment or to human or animal health; and

• (b) is issued a permit for the proposed release under section 160.

(2) Where the accompanying information that is required to be provided to the Minister pursuant to paragraph (1)(a) in respect of the proposed release of a veterinary biologic is the same as information that has already been provided to the Minister before the coming into force of sections 120.1 and 120.2, this section and sections 120.4 to 120.6, or that is provided on or after the coming into force of sections 120.1 and 120.2, this section and sections 120.4 to 120.6 in relation to an application for another permit, the information is not required to be provided again.

120.4 (1) The accompanying information that is required to be provided by a person to the Minister pursuant to paragraph 120.3(1)(a) includes the following:

• (a) the name of the person or body responsible for the proposed release and the name of the person who will be in charge of carrying out the release;

• (b) in the case of a live genetically modified veterinary biologic

  • (i) a description of the donor organism and the methods of incorporation of the genes from the donor organism into the host, and

  • (ii) a description of the live genetically modified veterinary biologic, including details relating to expression of the new gene and the stability of the incorporation of the new gene, and a comparison of the characteristics of the live genetically modified organism with those of the unmodified organism;

• (c) the protocol followed in preparing the veterinary biologic and any diluent to be used with it;

• (d) the procedures to be followed in handling, storing, administering, testing, releasing and disposing of the veterinary biologic and any diluent to be used with it;

• (e) the tests used to establish the purity, safety, potency and efficacy of the veterinary biologic and the purity and safety of any diluent used with it, and the results of all the tests;

• (f) the proposed starting date, time period and site of the release;

• (g) the proposed measures to mitigate any risk of harm to the environment or to human or animal health; and

• (h) any other information in respect of the veterinary biologic that is relevant to identifying any risk of harm to the environment or to human or animal health.

(2) The information required by paragraph (1)(h) or any part of that information may be omitted if the Minister determines, on the basis of a written scientific rationale provided by the person referred to in subsection (1), that the information or part is not relevant or cannot practicably be obtained and is not required for the issuance of a permit under section 120.5, and notifies the person of that determination.