Human Pathogens and Toxins Regulations

Marginal note:Conditions of licence

• 4 (1) Every licence is subject to the following conditions:

  • (a) the licence holder and any person who is conducting controlled activities authorized by the licence must not obstruct the biological safety officer when the officer is exercising their powers or carrying out their functions;

  • (b) a person who intends to conduct any of the following controlled activities must communicate that intention to the biological safety officer before they make any arrangements to do so:

    • (i) importing or exporting a human pathogen or toxin,

    • (ii) possessing a human pathogen or toxin as a result of receiving from another licence holder or from a person who is conducting controlled activities authorized by another licence, or

    • (iii) transferring a human pathogen or toxin to another licence holder or to a person who is conducting controlled activities authorized by another licence;

  • (c) a person who intends to transfer a human pathogen or toxin must, before the transfer, take reasonable care to be satisfied of the following:

    • (i) that the intended recipient is exempt from the requirement to hold a licence, or

    • (ii) that the intended recipient will conduct controlled activities in relation to that human pathogen or toxin in a facility that is set out in a licence that authorizes those controlled activities with respect to that human pathogen or toxin;

  • (d) a person who intends to export a human pathogen or toxin must, before they export it, take reasonable care to be satisfied that the intended recipient will conduct any activities in respect of the human pathogen or toxin in accordance with any applicable biosafety and biosecurity standards and policies in the foreign jurisdiction;

  • (e) the intended recipient of a human pathogen or toxin must make reasonable efforts to locate it if it is not received within a reasonable time after it was expected to be received, and must inform the biological safety officer of the situation without delay; and

  • (f) a person who discovers during the conduct of a controlled activity that they are inadvertently in possession of a human pathogen or toxin that is not listed in Schedule 5 to the Act in respect of which that controlled activity is not authorized by the licence must take all of the following steps:

    • (i) inform the biological safety officer of the inadvertent possession without delay,

    • (ii) ensure that the human pathogen or toxin is handled and stored appropriately while it is in their possession, and

    • (iii) within 30 days, dispose of it or transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.

• Marginal note:Additional condition — prescribed human pathogens and toxins

  (2) Every licence that authorizes controlled activities in respect of a human pathogen or toxin that is prescribed under section 10 is subject to the further condition that, if the intended recipient of such a human pathogen or toxin does not receive it within 24 hours after the expected date and time, they must take all of the following steps:

  • (a) make reasonable efforts to locate it;

  • (b) inform the biological safety officer without delay that they have not received it; and

  • (c) provide the biological safety officer with any other information that is relevant to preventing any undue risk to the health or safety of the public.