Representative crops and extrapolation principles for risk assessment and data waivers

As part of the Australian Government’s commitment to improved access to agricultural and veterinary chemicals, the Australian Pesticides and Veterinary Medicines Authority (APVMA) has developed Australian crop groups. Crop grouping schemes, once established, enable formal recognition of data generated and risk assessments conducted in a subset of crops to be extrapolated to other related crops of the same crop group. This mechanism identifies key crops where data generation may occur and where that data may then be used to support registration in other related crops. It assists applicants by clearly understanding what those crops are and maximises the value of that data once generated.

Crop grouping and the principle of data extrapolation also improves access to chemicals for minor crops where registrants may not otherwise consider their inclusion for reasons of insufficient economic return. The assessment and requirements for approving minor crops can therefore leverage off regulatory risk assessments that are conducted and approved in representative crops, which are typically major crops. This is a common practice among international regulators and is used to streamline regulatory assessment and facilitate approvals for minor crops. The APVMA has applied these principles for many years, particularly in assessments for minor crops. This document formalises our approach with the aim to increasing applicant’s awareness of its potential use in registration.

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