Human Pathogens and Toxins Regulations (SOR/2015-44)

Marginal note:Records

25 The licence holder must keep a record of the full name of every person who enters a facility under accompaniment and supervision, together with the date on which they entered and the full name of the person who accompanied and supervised them.

Exemptions

Marginal note:Exemption from Risk Group 2 — risk reduction

• 26 (1) A human pathogen that is listed in Schedule 2 to the Act is exempt from the application of the definition Risk Group 2 in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

• Marginal note:Exemption from Risk Group 3 — risk reduction

  (2) A human pathogen that is listed in Schedule 3 to the Act is exempt from the application of the definition Risk Group 3 in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

• Marginal note:Exemption from Risk Group 4 — risk reduction

  (3) A human pathogen that is listed in Schedule 4 to the Act is exempt from the application of the definition Risk Group 4 in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

• Marginal note:Notice to Minister

  (4) In the circumstances described in subsections (1) to (3), the licence holder must notify the Minister without delay after such a modification.

Marginal note:Exemption from licence requirement — laboratories

• 27 (1) A person who carries out laboratory analyses or diagnostic testing with a human pathogen that is neither a prion nor a prescribed human pathogen is exempt from the application of section 7 of the Act on condition that

  • (a) they do not cultivate or otherwise produce a human pathogen; or

  • (b) if there is any production, it is done using a sealed container that prevents the release of the human pathogen and that is decontaminated before its disposal or reuse.

• Marginal note:Exemption from licence requirement — veterinary practices

  (2) A veterinarian who is registered under the laws of a province — and any persons under their supervision — who carry out laboratory analyses or diagnostic testing with a human pathogen that falls into Risk Group 2 are exempt from the application of section 7 of the Act on condition that any controlled activities that they conduct in respect of that pathogen are conducted in the course of providing care to animals in a clinical practice in that province.

Marginal note:Exemption — section 33 of Act

28 A person is exempt from the application of section 33 of the Act with respect to a part of a facility on either of the following conditions:

• (a) there is no prescribed human pathogen or toxin present in that part of the facility, or

• (b) any prescribed human pathogen or toxin that is present is locked up and inaccessible to that person.

Documents

Marginal note:Document retention

• 29 (1) Documents that are required under the Act to be prepared must be maintained for five years after the day on which they are prepared and must be provided to the Minister on request.

• Marginal note:Exception — incidents

  (2) Despite subsection (1), the retention period is 10 years for documents that contain information that relates to the following incidents:

  • (a) an incident that is described in subsection 12(1) or (2), or section 13 or 14, of the Act; and

  • (b) any incident that results in a failure of or compromise to biocontainment.

Marginal note:Receipt of documents

30 Any document that is sent by the Minister under the Act is considered to have been received on the earlier of the following days:

• (a) the day that is five days after it was sent, and

• (b) the day on which it is received.

Transitional Provisions

Marginal note:Continuation of controlled activities

• 31 (1) A person who, on the day on which these Regulations come into force, conducts controlled activities in respect of a human pathogen or toxin is exempt from the application of section 7 of the Act if they submit an application for a licence under subsection 18(2) of the Act within 90 days after that day.

• Marginal note:Duration

  (2) Subsection (1) applies until the Minister issues or refuses to issue the licence under subsection 18(1) or (3) of the Act, respectively.

Marginal note:Continuation of controlled activities — prescribed human pathogens and toxins

• 32 (1) An individual who, on the day on which these Regulations come into force, conducts controlled activities in respect of a prescribed human pathogen or toxin is exempt from the application of section 33 of the Act if they submit an application for a security clearance under section 12 within 90 days after that day.

• Marginal note:Duration

  (2) Subsection (1) applies until the Minister issues or refuses to issue the security clearance under subsection 34(1) of the Act.

Coming into Force

Marginal note:December 1, 2015

33 These Regulations come into force on December 1, 2015.