The Australian Government has committed
$8 million over four years (2014-2018) to help farmers gain improved access to safe and effective agricultural and veterinary (agvet) chemicals, to assist them in producing food for Australia and the world.
The Department of Agriculture and Water Resources is working closely with the Australian Pesticides and Veterinary Medicines Authority (APVMA), grower groups, rural Research and Development Corporations (RDCs) and the chemical industry to deliver this commitment.
A number of activities have commenced under the initiative, including work to:
- develop and implement an agvet collaborative forum to allow stakeholders to more effectively share their access needs with each other and chemical companies
- establish an official Australian crop grouping list and associated APVMA guidelines
- migrate some APVMA permits to product labels
- develop an assistance grants programme to help fund the generation of sufficient data to support applications to the APVMA.
All interested stakeholders will continue to have the opportunity to provide input.
In addition to the work taking place under the new funding, the government is also committed to reforming agvet chemicals regulation to improve the efficiency and effectiveness of the system and increase access to chemicals.
The department has progressed a number of options under the new funding to improve access to agvet chemicals, as listed below.
The department has provided a grant of $218 182 (GST not applicable) to the Rural Industries Research and Development Corporation (RIRDC) to deliver a collaborative forum for sharing priorities and fostering collaboration.
The collaborative forum promotes information sharing and co-investment opportunities for supporting applications to the APVMA for agvet chemical uses. Initial stakeholder meetings, including the first meeting on 7 November 2014, were used to develop the role and operational details of the forum. RIRDC hosted successful plant and animal priority setting workshops in June 2015, which delivered the first cross-industry agreed list of priority needs for uses of agvet chemicals.
The forum will meet again on 8–9 June 2016 and will deliver a second cross-industry agreed priority list by 30 June 2016.
For more information, or to become involved with the forum, please contact RIRDC.
The department has provided a grant of $130 000 (GST not applicable) to the APVMA to establish an official Australian list of crop groupings and develop associated guidance.
Establishing an official crop grouping list will reduce regulatory costs for producers to gain access to more uses of agricultural chemicals. Crop grouping will maximise the use of data generated in other crops through extrapolation to a group of crops, with little or no additional data needed. In practice, where registration/permit has been gained for representative crops, automatic extension or approval would be allowed to all other crops within the group (and possibly across groups) without the need for additional data or review.
This project will allow the APVMA to deliver the following activities and outcomes:
The APVMA will build on its preliminary work and finalise the establishment of an official Australian crop groups list, and the individual crops which form these groups.
On 30 October 2015, the APVMA released its draft Australian crop grouping list for consultation and in April 2016 released the consolidated responses to the consolation.
* While Phase 1 has been delayed, the APVMA now intends to run much of Phase 2 in parallel with the remaining stages of Phase 1. As such, it is expected that Phase 2 will still be completed by its original due date.
30 June 2015*
The APVMA will review its existing data guidelines based upon the new developed crop groups and their representative crops. This involves identifying representative crops for each group across all disciplines for meeting the safety, efficacy and trade registration criteria.
30 June 2016
For more information on the APVMA’s consultation on the improved access to agvet chemicals initiative, including the crop grouping project, please contact the APVMA.
Migrating permits to labels
The department has provided a grant of $240 000 (GST not applicable) to the APVMA to examine all permits currently issued to peak industry bodies (involving uses in crops and livestock species) and determine suitable candidates for migration from APVMA permit to product label (registration), and to then liaise with the holders of registration to seek to get uses onto labels of registered products.
The duration granted by the APVMA for a permit can vary from one season to up to 10 years. As permits have a limited duration, permit holders must periodically submit applications to the APVMA to renew permits. This may or may not require submission of new data. This renewal activity can consume a significant amount of resources from stakeholders’ existing access to chemicals programmes, as well as the APVMA as it has to assess these renewal applications. Migrating uses on permits to product labels would eliminate the need for some existing permits, reduce future demand for permits and provide greatest access to a use (listed on the label of the product).
This project will allow the APVMA to deliver the following activities and outcomes:
APVMA engages peak industry bodies to determine the order for batching reviews of active ingredient and individual permits
Before 31 December 2015
APVMA documents reasons, arguments etc for why use could be migrated
In parallel to review process (such as batches every quarter). Final cases prepared by 31 January 2018.
APVMA delegate decision on migrating to label, advise permit holder and publish suitable uses. For uses with some data gap preventing migration, APVMA to advise the permit holder and, if practicable, describe the data gap/issue.
As soon as practicable (within no more than one month) after supporting case has been developed.
APVMA consults actively with registration holder(s) about willingness to allow use(s) to be added to label. APVMA advises permit holder about whether a label use can be pursued and if so, APVMA’s expected timeframe.
As soon as practicable (within no more than one month) after delegates decision.
With registration holder(s) written consent, APVMA to vary the registration and relevant particulars of the label approval to include the use.
As soon as practicable (within no more than three months) after registrant’s agreement.
For more information on the APVMA’s consultation on the improved access to agvet chemicals initiative, including the permits to labels project, please contact the APVMA.
The department has developed an assistance grants programme to help with the generation of sufficient data to support applications to the APVMA for agvet chemical uses identified as a priority by the collaborative forum.
The Assistance Grants – Improved Access to Industry Priority Uses of Agvet Chemicals grants programme will provide short term relief to producers while longer-term solutions are developed and implemented through broader reforms.
The first round of assistance grants closed on 24 November 2015. The second round of assistance grants will be open for applications between 1 July 2016 and 30 September 2016.
The agvet chemical access issue
Access to safe and effective agvet chemicals is important to Australian agricultural and livestock industries, the community and the environment.
Farmers use agvet chemicals to help protect crops and animals from pests and diseases, and treat infections when they occur.
However, Australian farmers sometimes have difficulties getting access to the particular uses of an agvet chemical that are available to overseas competitors.
The small size of the Australian market can make the costs involved with registering an agvet chemical for its use in Australia uncommercial. This is particularly the case for treating pests and diseases in specialty crops and livestock species. Larger industries face a similar problem managing uncommon or emerging pests and diseases. These chemical access issues are often referred to as the ‘minor use’ issue.
About the improved access to agvet chemicals initiative
The initiative will improve access to agvet chemicals and increase the number of uses available to producers. To successfully deliver enduring improvements to access to agvet chemicals the initiative will:
- Improve the ability of producers to effectively share their needs and priorities for uses of agvet chemicals between themselves, grower groups, chemical companies and government.
- Improve producers’ access to a broader range of Australian approved uses for those agvet chemicals already in the Australian market.
- Improve the number of approved uses that chemical companies choose to bring to the Australian market when introducing a new agvet chemical to Australia.
This is a complex problem and stakeholders have a range of views on how it should be addressed. The department continues to consult with stakeholders to explore specific options to deliver these improvements.
About the new funding
The government currently contributes funding to the research and development corporations to:
- identify access and user needs for agvet chemicals, and
- generate data to support applications for APVMA minor use permits.
The government also currently provides about $145 000 annually towards the APVMA’s minor use programme.
The $8 million announced in the 2014-15 budget under the improved access initiative is in addition to this existing funding.
The $8 million is being provided over four years as follows:
|Total $0.0 M||0.7||2.1||2.9||2.3||8.0|
The most sustainable solution to improve access to agvet chemicals is to review the existing administrative and legislative framework to improve the efficiency and effectiveness of the system. Industry, community, users and the Australian Government have identified a number of potential reform opportunities for the regulation of agvet chemicals, including opportunities to further improve access to safe chemicals and chemical uses. The department has identified possible reforms in consultation with stakeholders, including options to:
- investigate options to remove unnecessary regulatory barriers to registration of products and uses
- facilitate greater reliance on international data, assessments or decisions
- support increased access to agvet chemicals where appropriate.
More information on future reforms, including how to contribute to the reform development process, can be found on the department's website.
Share your views
Stakeholders understand how gaps in the supply of agvet chemicals can affect producers. We welcome your insights on how to tackle the problem and support industry. Please consider the opportunity to share these insights through the Agvet Collaborative Forum and the regulatory reform consultation processes. We also invite you to provide your ideas directly to the Agvet Chemicals Policy Section.
In 2014 we also invited a small number of subject matter experts to join an informal advisory group, to help strengthen the department’s initial understanding of the diversity of concerns and to advise on implementing potential solutions. These experts were chosen to cover specific areas of expertise or experience – they were not representative of all interested stakeholders. Numbers were kept to a minimum to maintain the efficiency of the group. The advisory group was to enhance, not replace, our continued efforts to consult broadly with stakeholders.
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