Chapter 3Performance management report

Strategy 6: Identify and manage emerging regulatory issues

The APVMA is proactive in managing emerging regulatory issues. The APVMA has continued to develop and implement reforms relevant to the regulation of pesticides and veterinary medicines led by the Australian Government and COAG. In addition, the APVMA has been active in informing policy processes across government about the role of pesticide and veterinary medicine regulation and the factors affecting its efficiency and effectiveness.

Continuous improvement – engagement with DAFF, the Product Safety and Integrity Committee and regulatory agencies

COAG Review of Chemicals and Plastics Regulation

COAG has agreed to review chemicals and plastics regulation. One aim of the review is to develop a proposal of a single, national framework to improve the efficiency and effectiveness of the regulation of agricultural and veterinary chemicals. The work is being led by the Product Safety and Integrity Committee, which developed a set of principles for a new national scheme (agreed by COAG in August 2010) and released a consultation regulation impact statement in December 2010. Further information about this review can be found at

The APVMA is an observer on of the Product Safety and Integrity Committee and participated at regular meetings of the Committee throughout the year, including a stakeholder workshop held in June 2010 and a meeting held with the Agricultural Chemicals and Veterinary Medicines group within the New Zealand Ministry for Agriculture. The APVMA’s role is to actively participate at these forums, to inform the policy development by bringing technical and operational data and our extensive regulatory experience and expertise to the table.

Reform activities

COAG Early Harvest Reforms

The APVMA has continued to be active in developing and delivering operational reforms and contributing to targeted policy reform activities. The APVMA and DAFF developed a joint workplan with identified priorities in areas of responsibility and key milestones with regular reporting. The APVMA was initially allocated primary responsibility for:

  • Reform 8: Agricultural and veterinary chemical labelling reform — regulatory box
  • Reform 10: Regulatory process for low risk agricultural and veterinary chemicals.

Both of these reforms are finalised.

Reform 8 was finalised in June 2010 and has now been formalised through legislative amendments in July 2010. Reform 10, which facilitates the registration of low-risk pesticides and veterinary medicines at reduced cost, has culminated in the development of registration model (template) for a class of equine electrolyte products. The APVMA has also continued to provide significant input to reforms 4 (Dairy cleaners), 5 (Water sanitisers for industrial use) and 7 (Scope of regulation), for which DAFF has primary carriage. Reform 9 (Data protection for chemical review) has been incorporated into the Better Regulation reform agenda.

Better Regulation Ministerial Partnership

The Better Regulation Ministerial Partnership between the Minister for Agriculture, Fisheries and Forestry and the Minister for Finance and Deregulation is evaluating possible reforms to improve the efficiency and effectiveness of the APVMA.

Better Regulation Tranche 1

The first tranche of legislative amendments originating from the Better Regulation Ministerial Partnership (Better Regulation Tranche 1 or BeRT 1) was developed and passed into law on 15 July 2010. The primary objective of the BeRT 1 reforms was to improve the efficiency and timeliness of pesticide and veterinary medicine regulation in Australia by:

  • removing the requirement for the APVMA to approve the final printed label
  • reducing the authorisation requirements for approved persons
  • allowing variation as to registration particulars without APVMA assessment
  • including the consideration of trade issues when the APVMA looks at product instructions
  • allowing the APVMA to discuss permit applications for minor or emergency uses with other persons.

These reforms have delivered significant efficiencies to the administration of label approval and the management of approved persons, as well as introducing statutory arrangements for ‘notification’ applications.

Amendments to regulations commenced on 18 March 2011. The amendments established new label approval arrangements including statutory conditions of label approval and defining the relevant label particulars. The regulations also established a label notifications scheme, a Poisons Standard and a Labelling Standard. Under the new arrangement, registrants may make certain changes to labels without making an application to the APVMA.

Better Regulation Tranche 2

The Better Regulation Taskforce was formed within the APVMA in January 2011 in response to the Minister for Agriculture, Fisheries and Forestry’s Better Regulation of Agricultural and Veterinary Chemicals Policy Discussion Paper. The reforms outlined in the discussion paper aim to increase the efficiency and effectiveness of the APVMA, assist the chemical industry to operate more effectively, enhance protection of human health and the environment, and protect access to chemicals in agriculture. The reforms relate to Australian Government commitment to enhance the pesticides and veterinary medicines sector.

DAFF is leading these reforms as the policy department for pesticides and veterinary medicines. The APVMA is working to inform the development of the reforms and coordinating their implementation.

Establishing the Better Regulation Taskforce has enabled the APVMA to continue to focus on core business, with the taskforce providing an organisational focus for the APVMA to help inform the policy refinement and implementation processes. The operational implementation of the reforms will pose significant challenges and require extensive input and cooperation from all areas of the APVMA. The additional government funding provided to the APVMA will enable the reforms to be implemented while maintaining delivery of regulatory services to stakeholders.

The eight reform themes in the Better Regulation reform agenda

  • Implementing complete risk frameworks for assessment and review of agricultural and veterinary chemicals
  • Improve the quality and efficiency of agricultural and veterinary chemical assessment (APVMA business improvement)
  • Introducing a re-registration scheme
  • Using overseas assessments to their full extent
  • Establishing an independent science panel
  • Enhancing the provision of expert advice (Advisory Board)
  • Improving legal interactions with the APVMA
  • Improving the APVMA’s compliance enforcement capacity

Engaging the media

The APVMA continued to influence the public perception of regulatory issues by engaging the media to facilitate accurate reporting of the organisation’s position. This is achieved through both proactive and reactive media management.

Proactive engagement of the media was undertaken through the issue of seven media releases, 25 ‘Regulatory news’ notices and 14 ‘Our view’ statements. The organisation also responded to
202 media requests. This is the highest number of media contacts recorded and resulted in a significant ‘share of voice’ in media reports.

Proactive issues management

The APVMA’s approach to media and issues management attracted positive feedback from industry and government sectors around the world. The ‘Our view’ statements and ‘Community questions’ that are published on the website continue to be important resources for media, industry and the community in understanding the APVMA’s position.

Strategic issues screening was undertaken quarterly with the active involvement of senior staff in identifying, ranking and monitoring emerging and ongoing issues.

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