These regulations set out the process for the Minister responsible for the administration of the Biosecurity Act 1993 to assign responsibility for a decision on the appropriate response to an issue relating to a harmful organism or pathway. The process involves an application requesting that the Minister assign responsibility for the decision; the Director-General giving the Minister initial advice on the merits of the application; the Minister making an initial decision on whether to consider the application; the Director-General consulting with parties potentially affected by the assignment of responsibility; the Director-General giving the Minister final advice on whether to assign responsibility for the decision and, if so, to whom; the Minister making final decisions on whether to assign responsibility for the decision and, if so, to whom; the Minister notifying the applicant, the parties to whom the Minister assigns responsibility, and the public of the final decisions made.