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

Regulations are current to 2019-06-20 and last amended on 2019-04-15. Previous Versions

PART XGeneral Provisions (continued)

Animal Semen Production Centre (continued)

[SOR/97-85, s. 69]
  •  (1) Every person who operates an animal semen production centre shall keep and make available for inspection by an inspector a record showing

    • (a) the date each animal entered the centre;

    • (b) the name and address of the owner of each animal or of the person from whom the animal was acquired;

    • (c) the premises from which each animal entered the centre;

    • (d) all tests performed on each animal, the date and results of each test and the person who performed the tests;

    • (e) each date semen was collected from each animal, the quantity collected and the disposition of the semen;

    • (f) the identity of the semen that is stored in the centre; and

    • (g) the date each animal was removed from the centre, the reason for the removal and the disposition of each animal.

  • (2) Every person who collects, stores, distributes or sells animal semen shall keep and make available for inspection by an inspector

    • (a) a record of the dates and quantities of semen imported, exported, sold, distributed, used or otherwise disposed of; and

    • (b) a record of all semen stored by him identified as to the animals from which it was collected.

  • (3) Every record required to be kept pursuant to this section shall be in a form approved by the Minister and shall be maintained for a minimum period of seven years.

  • SOR/79-295, s. 19
  • SOR/97-85, s. 71
  • SOR/97-478, s. 17

PART XIVeterinary Biologics

[SOR/95-54, s. 4(F)]

 In this Part,

manufacture

manufacture does not include the sole process of labelling; (fabriquer)

veterinary biologic

veterinary biologic does not include an antibiotic except when it is used as a preservative or when it is an integral part of the veterinary biologic. (produit vétérinaire biologique)

  • SOR/79-295, s. 20
  • SOR/86-291, s. 1
  • SOR/95-54, s. 6(F)
  • SOR/2002-438, s. 8

Permits to Release Veterinary Biologics

[SOR/2002-438, s. 9(F)]

 In sections 120.2 to 120.6,

confinement procedure

confinement procedure means any physical, chemical, operational or biological control, or any combination thereof, intended to restrict the exit or dispersal from confinement of a veterinary biologic that contains an organism or a part or product of an organism; (méthode de confinement)

containment

containment means containment in accordance with the Laboratory Biosafety Guidelines established by the Department of National Health and Welfare and the Medical Research Council of Canada and published in 1990, as amended from time to time; (confinement)

environment

environment means the components of the Earth and includes

  • (a) air, land and water,

  • (b) all layers of the atmosphere,

  • (c) all organic and inorganic matter and living organisms, and

  • (d) the interacting natural systems that include components referred to in paragraphs (a) to (c); (environnement)

live genetically modified veterinary biologic

live genetically modified veterinary biologic means a live veterinary biologic that contains or is made from an organism and is produced by recombinant DNA technology; (produit vétérinaire biologique vivant et génétiquement modifié)

release

release means any discharge or emission of a veterinary biologic into the environment. (dissémination)

  • SOR/97-8, s. 2
  • SOR/2002-438, ss. 9(F), 18(F)
  •  (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.

  • SOR/97-8, s. 2
  • SOR/2002-438, s. 18(F)
  •  (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.

  • SOR/97-8, s. 2
  • SOR/2002-438, s. 18(F)

Information Requirements

  •  (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.

  • SOR/97-8, s. 2
  • SOR/2002-438, ss. 10(F), 18(F)
 
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