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

131 Where the Minister is satisfied from tests of a veterinary biologic, or otherwise, that a veterinary biologic is unsafe to use, is likely to cause communicable disease in animals or is contaminated or ineffective, he may, by order, prohibit the importation, manufacture, sale or distribution of the veterinary biologic.

• 131.1 (1) Where an emergency exists with respect to the availability of and need for a veterinary biologic, the Minister may exempt that veterinary biologic from the application of any of the provisions of these Regulations during the period of the emergency.

• (2) An exemption referred to in subsection (1) shall be in writing and shall state the veterinary biologic that is exempted, the provision or provisions of these Regulations from which it is exempted and the reasons for that exemption.

• (3) The Minister may at any time cancel the exemption referred to in subsection (1).

• 132 (1) No person shall sell, advertise or offer for sale a veterinary biologic unless it is packaged and labelled in accordance with these Regulations.

• (2) All information required by section 134 to be shown on the label of a veterinary biologic

  • (a) shall be clearly and prominently displayed on the label; and

  • (b) shall be readily visible by a purchaser under the customary conditions of purchase and use.

133 Every veterinary biologic sold, advertised or offered for sale in Canada shall carry a label.

• 134 (1) Subject to subsection (2), every label of a veterinary biologic sold, advertised or offered for sale in Canada shall show

  • (a) the assigned name of the veterinary biologic,

  • (b) the name of the manufacturer of the veterinary biologic or, if there is more than one manufacturer of that veterinary biologic, the name of the first or the name of the final manufacturer,

  • (c) the place where the manufacturer referred to in paragraph (b) manufactures the veterinary biologic,

  • (d) the lot or serial number or other means of identifying the veterinary biologic,

  • (e) the same establishment licence number, whether Canadian or foreign, on all components of the label except that the Minister may, in writing, exempt from that requirement diluents manufactured in Canada,

  • (f) directions for use of the veterinary biologic or that directions for its use are contained inside the package,

  • (g) the expiration date of the veterinary biologic,

  • (h) the components of the veterinary biologic, including

    • (i) viruses, bacteria, toxoids and antibodies, and

    • (ii) antibiotics, if added during the production process as preservatives,

    • (iii) [Repealed, SOR/80-428, s. 11]

  • (i) the net quantity of the veterinary biologic in the container, expressed in metric units or in doses,

  • (j) the temperature range, expressed in metric units, necessary to maintain prescribed potency of the veterinary biologic,

  • (k) in the case of a veterinary biologic manufactured for use in food producing animals, the cautionary statement indicating the appropriate withdrawal period as stated in the product outline on the basis of which the import permit or product licence was issued, and

  • (l) the words “For veterinary use only” and “Pour usage vétérinaire seulement” or other wording to the same effect, and

  • (m) any cautionary information necessary to ensure the safe handling and use of the veterinary biologic.

• (2) Where the label of a veterinary biologic is too small to show all the information required by subsection (1), any such information as the Minister may permit may be shown on the directions for use inside the package.

• (3) Subject to subsection (4), the information required by subsection (1), as well as any supplemental information appearing on the label, shall be shown in both official languages, and may additionally be shown in whole or in part in any other language.

• (4) A person may sell, advertise or offer for sale in Canada a veterinary biologic that is labelled in only one official language if

  • (a) the Minister determines that the veterinary biologic is needed for research or emergency use; and

  • (b) the person undertakes to ensure its safe storage, handling and administration.

134.1 No person shall sell or offer for sale a veterinary biologic after its expiration date.

• 134.2 (1) Except as provided in subsection (2), no person shall sell or offer for sale a rabies vaccine to anyone other than a veterinarian of the Department of Agriculture of Canada or a veterinarian who holds a valid licence to practice veterinary medicine issued by the veterinary licensing body of a province.

• (2) Subsection (1) does not apply in respect of rabies vaccine that is sold or offered for sale in accordance with the written permission granted by the Minister for its use

  • (a) in a temporary emergency veterinary clinic; or

  • (b) in a remote area where veterinary services are not readily available.

• 135 (1) No person shall, in any advertisement for the sale of a veterinary biologic, make any claim with respect to the purity, safety, potency and efficacy of the veterinary biologic that is not supported by the product outline for such veterinary biologic.

• (2) No person shall, in any advertisement for the sale of a veterinary biologic, make any representation that is false, misleading or deceptive or that is likely to create an erroneous impression regarding the character, value, quality, composition, merit or safety of the advertised veterinary biologic.

• (3) [Repealed, SOR/97-85, s. 75]

135.1 Every holder of a licence or permit issued under this Part shall report to the Minister, in writing, any information concerning, or any evidence of, a significant deficiency in safety, potency or efficacy of a veterinary biologic within 15 days after the date on which that information or evidence is known to the holder.

PART XIITransport of Animals

Interpretation

• 136 (1) The following definitions apply in this Part.

  assembly centre

  assembly centre means a place to which animals are transported for the purpose of assembly and includes an auction market, an assembly yard and a holding facility, other than a slaughter establishment, that holds, on behalf of a slaughter establishment, animals that are destined soon afterwards for slaughter at that slaughter establishment. (centre de rassemblement)

  commercial carrier

  commercial carrier means

  • (a) the owner of a motor vehicle who is engaged in the business of transporting animals by land for financial benefit;

  • (b) the owner of an aircraft who is engaged in the business of transporting animals by air for financial benefit;

  • (c) the owner of a vessel who is engaged in the business of transporting animals by water for financial benefit; or

  • (d) a railway company. (transporteur commercial)

  compromised

  compromised, in respect of an animal, means an animal that

  • (a) is bloated but has no signs of discomfort or weakness;

  • (b) has acute frostbite;

  • (c) is blind in both eyes;

  • (d) has not fully healed after a procedure, including dehorning, detusking or castration;

  • (e) is lame other than in a way that is described in the definition unfit;

  • (f) has a deformity or a fully healed amputation and does not demonstrate signs of pain as a result of the deformity or amputation;

  • (g) is in a period of peak lactation;

  • (h) has an unhealed or acutely injured penis;

  • (i) has a minor rectal or minor vaginal prolapse;

  • (j) has its mobility limited by a device applied to its body including hobbles other than hobbles that are applied to aid in treatment;

  • (k) is a wet bird; or

  • (l) exhibits any other signs of infirmity, illness, injury or of a condition that indicates that it has a reduced capacity to withstand transport. (fragilisé)

  confine

  confine means, for the purpose of transporting an animal, to hold an animal in a conveyance or container from the time that the animal is in the conveyance or container until the time that the animal is out of the conveyance or container. (confinement)

  container

  container means a structure that is moveable, that has rigid sides and a rigid bottom and may have a cover and that is used to confine an animal and includes a cargo container and a crate. (caisse)

  humanely kill

  humanely kill means to kill as rapidly as possible with the least possible pain, suffering, fear and anxiety and includes to slaughter in accordance with applicable legislation. (tuer sans cruauté)

  nutritional deficit

  nutritional deficit means an inadequate amount of feed or deprivation of feed that causes behavioural or physiological effects. (déficit nutritionnel)

  safe water

  safe water means potable water or water that does not pose a risk to the health of the animal drinking it. (eau salubre)

  unfit

  unfit, in respect of an animal, means an animal that

  • (a) is non-ambulatory;

  • (b) has a fracture that impedes its mobility or causes it to exhibit signs of pain or suffering;

  • (c) is lame in one or more limbs to the extent that it exhibits signs of pain or suffering and halted movements or a reluctance to walk;

  • (d) is lame to the extent that it cannot walk on all of its legs;

  • (e) is in shock or is dying;

  • (f) has a prolapsed uterus or a severe rectal or severe vaginal prolapse;

  • (g) exhibits signs of a generalized nervous system disorder;

  • (h) is a porcine that is trembling, has difficulty breathing and has discoloured skin;

  • (i) has laboured breathing;

  • (j) has a severe open wound or a severe laceration;

  • (k) has sustained an injury and is hobbled to aid in treatment;

  • (l) is extremely thin;

  • (m) exhibits signs of dehydration;

  • (n) exhibits signs of hypothermia or hyperthermia;

  • (o) exhibits signs of a fever;

  • (p) has a hernia that

    • (i) impedes its movement, including when a hind limb of the animal touches the hernia as the animal is walking,

    • (ii) causes the animal to exhibit signs of pain or suffering,

    • (iii) touches the ground when the animal is standing in its natural position, or

    • (iv) has an open wound, ulceration or obvious infection;

  • (q) is in the last 10% of its gestation period or has given birth during the preceding 48 hours;

  • (r) has an unhealed or infected navel;

  • (s) has a gangrenous udder;

  • (t) has severe squamous cell carcinoma of the eye;

  • (u) is bloated to the extent that it exhibits signs of discomfort or weakness;

  • (v) exhibits signs of exhaustion; or

  • (w) exhibits any other signs of infirmity, illness, injury or of a condition that indicates that it cannot be transported without suffering. (inapte)

• (2) For the application of this Part,

  • (a) loading of an animal begins when the animal is handled, moved or caught for the purpose of confining it in a conveyance or a container and ends when the animal is confined in the conveyance, or if it is confined in a container, when the container is placed on the conveyance;

  • (b) in the case of an animal that is confined in a conveyance, unloading of the animal begins when the animal is handled or moved for the purpose of removing it from the conveyance and ends when the animal is removed from the conveyance or from any ramp, gangway, chute, step or apparatus used for unloading the animal; and

  • (c) in the case of an animal that is confined in a container, unloading of the animal begins when the container is handled or moved for the purpose of removing it from the conveyance and ends when the container is removed from the conveyance and the animal is removed from the container.

• (3) An animal that is both compromised and unfit as defined in subsection (1), is deemed not to be compromised.