Health of Animals Regulations

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.