Representative Crops and Extrapolation Principles for risk assessment and data waivers

Background

For the purpose of scientific assessment and regulation, crops are usually grouped through similarities in their botanical classification, morphology, growth habit, the portion of the commodity harvested and/or consumed, and cultural practices. This is a common practice among international regulators and is used to streamline the establishment of data guidelines and regulatory risk assessment.

The small size of the Australian market can make the costs involved with registering an agvet chemical or its use in Australia uncommercial. This is particularly the case for treating pests and diseases in specialty crops and minor livestock species.

The Australian Government, through the Department of Agriculture and Water Resources, has provided grants to the APVMA to establish an Australian crop grouping list. This page outlines the background to the project and current crop groupings arrangements.

By grouping crops together the use of data generated in certain crops can through extrapolation be extended to a group of related crops, with little or no additional data needed where use practices are the same or similar.

This work aims to:

• reduce the cost for industry of bringing chemicals to the Australian market
• streamline addition of more crop uses during the APVMA chemical registration process, and
• give farmers, and other chemical users, greater access to the chemicals they need to manage their crops.

In 2016 (Phase 1 of this project) the APVMA listed and grouped all commodities within each of 23 different crop groups. The complete list of commodities in each group is available at https://apvma.gov.au/crop-groups.

Phase 2 of this project is now proposing to identify representative crops/commodities for each crop group, and extrapolations possible from data and/or risk assessments conducted in the areas of residues, occupational health and safety, environment, efficacy and crop safety.

Invitation for submissions

The APVMA is seeking comments on:

1. The proposed:

(i) representative crops/commodities for each crop group, and

(ii) extrapolations possible from data and/or risk assessments conducted in representative crops/commodities both:

a. within a crop group, and

b. between crop groups.

2. The format and useability of the document (ie. ease of interpretation)

Please read the Representative Crops and Extrapolation Principles for risk assessment and data waivers document for more information.

How to make a submission

Submissions must be received by the APVMA by close of business on 5 October 2018 and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include:

• Contact name
• Company or group name (if relevant)
• Email or postal address (if available)
• The date you made the submission.

Written submissions should be addressed in writing to:

Registration Management and Evaluation
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Phone: +61 2 6210 4749
Fax: +61 2 6210 4776

Email: enquiries@apvma.gov.au and include Crop Grouping Project in the subject line.