Ref: MS14-000300
Ms Kareena Arthy
Chief Executive Officer
Australian Pesticides and Veterinary Medicines Authority
Box 6182
KINGSTON BC 2604
Dear Ms Arthy
I wrote to you in April 2014 to set out my expectations for regulatory behaviour for the Australian Pesticides and Veterinary Medicines Authority (APVMA). At that time I advised I would be providing you with a further letter of expectation following the government’s consideration of a framework for regulator performance. This framework was announced on 29 October 2014 and all Commonwealth regulators are now required to a have a regulator performance framework in place by 30 June 2015, ready for the first reporting period in 2015-16.
In addition to this requirement, the government released its Industry, Innovation and Competitiveness Agenda on 14 October 2014. This announcement included the adoption of a principle that ‘if a system, service or product has been approved under a trusted international standard or risk assessment, then regulators should not impose any additional requirements for approval in Australia, unless it can be demonstrated there is a good reason to do so’. This option has always existed for regulatory reform and the government’s decision now formalises this. Trusted international standards and risk assessments in this context could include those agreed multi-laterally or standards or assessments from certain overseas jurisdictions that are at the forefront of international best practice.
This letter sets out my expectations—and those of the government—in meeting the requirements of these two recent announcements. I want to reiterate that while the government has a broad role in setting policy, risk appetite and regulatory posture, it is important that the APVMA continues to act in accordance with the principles of best practice regulation, while still achieving its regulatory objectives, including those relating to the protection of human, animal and environmental health and international trade. Importantly, these new deregulation requirements should also take into account the intergovernmental agreement on the evaluation, registration and control of agricultural and veterinary (agvet) chemical products.
As you will be aware, the Government is committed to an ambitious deregulation agenda that aims to increase productivity and competitiveness by reducing regulatory burden on businesses, community organisations and individuals by at least $1billion a year. Achieving this target requires concerted effort across the Government, including from the agriculture portfolio’s regulatory agencies and I expect that the APVMA will continue to work with its regulated entities, stakeholders and the Agriculture Deregulation Unit to continue to identify opportunities to improve regulatory performance.
Regulator performance framework
In developing its regulator performance framework, I expect the APVMA will continue to work closely with the Agriculture Deregulation Unit to meet all relevant deadlines and to coordinate consultation, approval of frameworks and reporting requirements. The APVMA framework should align as far as is possible with performance and risk frameworks being developed under the Public Governance, Performance and Accountability Act 2013, although I appreciate that close alignment may not be fully realised until 2016. Your framework, developed in consultation with relevant stakeholders, is due to me by 30April 2015 (through the Agriculture Deregulation Unit).
I expect that in addressing the mandatory key performance indicators (KPIs) in the government’s framework, the APVMA will incorporate data/evidence collection and analysis processes in the most efficient way possible, so as to minimise any additional reporting burden on regulated entities. I expect that in designing this framework, the APVMA will include measures to identify the cost and burden of regulation, particularly around application processes. I also ask you to note that external reviews are a possibility on a three-yearly basis; such reviews would require an agreement between me and the Prime Minister.
International standards and risk assessments
An important first step towards implementing the decision is the development of criteria for assessing the applicability of international standards and risk assessments. The criteria will be used to assess the ongoing need for unique Australian standards in existing regulation as well as new regulation policy proposals. They are to be used to provide a transparent (public) framework for stakeholders as to how standards are assessed for their suitability for incorporation into regulatory frameworks (including primary and subordinate legislation).
The criteria would take into account, but not be limited to, the following considerations:
· the legitimacy of trusted international standards and risk assessments
· whether any Australian specific conditions or circumstances warrant distinct regulatory standards or risk assessment processes
· how reform might reduce regulatory burden and how reforms could deliver on portfolio red and green tape targets
· the ability of Australia to influence trusted international standards and risk assessments to ensure that Australian interests are taken into account
· costs and benefits of adopting international regulatory standards
· stakeholder feedback and any other relevant considerations.
In implementing this decision, I expect the APVMA will:
· develop suitable criteria for assessing the APVMA’s use (or potential future use) of regulatory standards and risk assessments, and publish these criteria during the first quarter 2015
· consider immediate opportunities for applying international standards and risk assessments in the concrete reform priorities that are currently being developed for input to the agriculture deregulation forward work programme
· note that divergence from international standards will need to be justified and published as part of the portfolio’s annual deregulation report
· seek the views of stakeholders to identify further opportunities for reform against the principle
· provide advice where policy consideration may be required to remove references to duplicative or divergent standards in primary or subordinate legislation.
You will be aware that under the intergovernmental agreement my state and territory colleagues are still working on a joint statement of expectations for the APVMA, which will be in addition to this letter. I will also be writing to those ministers to provide them a copy of this letter and encouraging them to provide input to the development of the APVMA’s regulator performance framework in the coming months.
I intend to make this letter publicly available from the Department of Agriculture’s website and request that you provide a link from the APVMA website to this letter when available. You should also ensure that all relevant frameworks, criteria for considering international standards and risk assessments, etc. are available from the APVMA website in due course.
Thank you for your proactive approach to meeting the deregulation agenda requirements and your engagement with the Agriculture Deregulation Unit to date.
Yours sincerely
[signed]
Barnaby Joyce MP
CC: State and territory ministers responsible for agvet chemicals regulation
19 Dec 2014
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