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

120.5 (1) The Minister may issue a permit for the release of a veterinary biologic under section 160 where the Minister, in addition to being satisfied that the proposed release meets the criteria set out in subsection 160(1.1), is satisfied that, to the best of the Minister’s knowledge and belief, the proposed release is unlikely to pose a risk of harm to the environment or to human or animal health.

(2) In evaluating the risk of harm to the environment and to human and animal health for the purposes of subsection (1), the Minister shall

• (a) consider such matters as

  • (i) the effects of the proposed release on the environment and on human and animal health, and

  • (ii) the magnitude of the exposure to the environment of the veterinary biologic involved in the proposed release; and

• (b) assess whether the veterinary biologic will enter or may enter the environment in a quantity or concentration or under conditions

  • (i) having or that may have an immediate or long-term harmful effect on the environment or on human or animal health,

  • (ii) constituting or that may constitute a danger to the environment on which human or animal life depends, or

  • (iii) constituting or that may constitute a danger in Canada to human or animal life or health.

(3) In addition to the conditions referred to in paragraph 160(2)(b), a permit for the release of a veterinary biologic shall contain such conditions as the Minister considers advisable to prevent harm to the environment or to human or animal health.

(4) In addition to any of the reasons set out in any of paragraphs 160(3)(a) to (c), the Minister may cancel or suspend a permit for the release of a veterinary biologic if the Minister has reason to believe that failure to do so could result in harm to the environment or to human or animal health.

120.6 (1) Where, at any time after the applicant submits an application for a permit referred to in paragraph 120.3(a) or is issued a permit for the release of a veterinary biologic under section 160, the applicant becomes aware of any new information regarding the risk of harm to the environment or to human or animal health, or the risk of introducing into Canada or spreading within Canada any vector, disease or toxic substance, that could be caused as a result of the release, the applicant shall immediately provide the new information to the Minister.

(2) Where the Minister, on the basis of the new information provided by an applicant pursuant to subsection (1), re-evaluates the risk of harm to the environment and to human and animal health posed by the release and determines that there is

• (a) a risk that is less than was apparent at the time that information was first provided or at the time any new information was subsequently provided, the Minister may

  • (i) where the release has already been authorized, maintain the existing conditions respecting the release,

  • (ii) change the conditions respecting the release, or

  • (iii) remove any conditions respecting the release;

• (b) a risk that is greater than was apparent at the time that information was first provided or at the time any new information was subsequently provided, the Minister may amend the permit for the release by

  • (i) imposing additional conditions respecting the release, or

  • (ii) changing the conditions respecting the release; or

• (c) an unacceptable risk, the Minister shall

  • (i) refuse to issue a permit for the release, or

  • (ii) where a permit for the release has already been issued, cancel the permit and require the applicant to stop the release and to take any appropriate action necessary to eliminate or minimize the risk.

(3) In re-evaluating the risk of harm to the environment and to human and animal health on the basis of new information for the purposes of subsection (2), the Minister shall consider the matters referred to in paragraph 120.5(2)(a) and make the assessment referred to in paragraph 120.5(2)(b).