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7 New Pathways

This section considers two new pathways to:

  • enable rapid approval for substances needed in an environmental emergency
  • enable rapid reassessment if the approval pathway was rapid assessment.

7.1 Reassessment by rapid assessment

Presently reassessments for hazardous substances must be considered using the full assessment provisions of the Act, even if the original approval went through the rapid assessment route. This means that a full weighing of adverse and positive effects needs to be undertaken and the application publicly notified.

This situation is rigorous, but it is also slow and cumbersome, which can tie up resources unnecessarily. There is also an element of inconsistency if the substance that was originally approved using the rapid assessment provision needs to be reassessed because, say, new information becomes available, and the only available pathway requires public notification.

We believe there is a case for some kind of rapid reassessment pathway, but our thinking is at an early stage. Your input would be appreciated.

QUESTIONS

26. We propose there should be a non-notified rapid reassessment pathway for hazardous substances applications that were originally approved without public notification. What is your opinion?

7.2 Environmental emergencies: emergency approvals

The NO&OM bill amended the HSNO Act to provide a new process for fast-track approvals for agricultural compounds (pesticides) and animal and human medicines needed for biosecurity or public health emergencies. New pesticides or medicines are sometimes needed at very short notice because of the exotic nature of the risks to be managed. Existing emergency provisions in the Act were considered unsatisfactory.

While considering policy for biosecurity or public health emergencies, officials noted that there are no similar emergency provisions for environmental disasters such as oil spills. The concept was not further investigated at the time because:

  • the NO&OM bill was a response to the recommendations of the Royal Commission and the Commission had not considered this issue
  • there was insufficient information about products used in environmental emergency situations and, in particular, the possibility of a product (or formulation) being needed that did not already have an HSNO approval (eg, the detergents used to clean up oil spills are already widely used in industry)
  • creating an emergency approval pathway runs the risk that applicants could attempt to use it to bypass normal ERMA assessment processes.

QUESTIONS

27. Do we need a fast-track provision in the HSNO Act so that new products could be approved for use in environmental emergencies as they are for biosecurity and public health emergencies? If yes, can you supply evidence showing such a provision is necessary?

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