Harmonisation of off-label use in agricultural chemicals
In 2017, the Agriculture Ministers’ Forum (AGMIN) tasked HACCUT to develop a proposal for nationally harmonising off-label use of agvet chemicals.
HACCUT undertook two rounds of public consultation in November 2017 and August 2018, which revealed a significant lack of stakeholder consensus on the policy to harmonise off-label use. Based on consultation, HACCUT developed an initial set of national harmonisation reforms to improve the harmonisation of off-label use in agricultural chemicals (listed below) and is considering how wider harmonisation can be achieved. In 2019, AGMIN agreed to a set of initial national harmonisation reforms and implementation of these reforms is underway for completion by 2023.
Table 1 illustrates the implementation status of wider reform measures for the harmonisation of off-label use in agricultural chemicals.
Amending the definition of ‘minor use’
One of the initial reforms agreed to by AGMIN, is to amend the definition of ‘minor use’ (which applies to both agricultural and veterinary chemicals) to allow the Australian Pesticides and Veterinary Medicines Authority (APVMA) to address circumstances where ‘a lack of sufficient and suitable chemical product exists’.
Currently, the definition of ‘minor use’ in the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Code Regulations) prevents the APVMA from issuing a minor use permit where there is a chemical product registered for that use, regardless of whether or not the chemical product is actually available to agvet chemical users. The proposed amendment to the Code Regulations will enable the APVMA to issue minor use permits for a given use in situations where one or more products are registered for that use but none of these are available anywhere in Australia. The standard fee and timeframes for minor use permits would apply.
Given the potential benefits of this measure to users, the department has proposed that this measure be applied to both agricultural and veterinary chemicals.
The department will provide more information on how this reform will be represented in the Code Regulations when it consults on other proposed amendments to agvet chemical regulations. Those amendments are primarily intended to support the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019. Consultation on the proposals is expected in 2021.
Initial national harmonisation reforms, agreed to by AGMIN in 2019, to improve the national harmonisation of off-label use in agricultural chemicals
- To extend the existing off-label provisions (for using an agricultural chemical at a lower rate, frequency, concentration or to treat a different pest than listed on the product label) to permits issued to ‘persons generally,’ excluding vertebrae poisons.
- To apply APVMA registered products and minor use permits nationally, where they have been approved for use in two or more jurisdictions. A use will not be allowed:
- where the approved label instructions include critical comments or restraints specifying a calendar timing or geographical region for application or non‑application
- for pests or uses specified by legislative instrument.
- To allow the APVMA to issue minor use permits in situations where ‘a lack of sufficient and suitable chemical products’ exists. The APVMA will still be required to:
- consult with state coordinators consistent with current practices
- be satisfied that the use of products under permit meet the safety, efficacy and trade criteria
- be satisfied the holder of the permit is a ‘fit and proper person’.
|Harmonisation measure||Implemented (Yes(Y)/ Underway(U)/ No(N))|
|Rates of application||Lower rate than on label||U||Y||Y||Y||Y||Y||Y||U|
|Higher rate than on label||N||N||N||N||N||N||N||N|
|Lower frequency than on label||U||Y||Y||Y||Y||Y||Y||U|
|Higher frequency or rate than on label||N||N||N||N||N||N||N||N|
|Pests||Different pest than on label||U||U||Y||Y||Y||Y||Y||U|
|Crops and situations||Different crop or situation than on label||N||N||N||N||N||N||N||Y|
|Application equipment (n/a)||Different application equipment than on label||N||N||Y||Y||Y||Y||N||Y|
|AGMIN-agreed off-label measures (2019)||Allow products registered for use in two or more jurisdictions to be used in all jurisdictions for uses included in APVMA approved label*||U||U||U||U||U||U||U||U|
|Allow permits issued to “persons generally”, other than emergency use permits, for two or more jurisdictions to apply in all jurisdictions*||U||U||U||U||U||U||U||U|
|Allow holders of approval and registration to also be holders of permits where ‘a lack of sufficient and suitable chemical options exists’*||U||U||U||U||U||U||U||U|
|Extend the existing AGMIN endorsed label arrangements for rates of application (above) to permits issued to “persons generally”*||U||U||U||U||U||U||U||U|
*subject to the conditions described above.