This content is current only at the time of printing. This document was printed on 23 September 2018. A current copy is located at https://apvma.gov.au/node/29161
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Annual Report 2013–14—Chapter 1: Organisation review
Chapter 1: Organisation overview
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the independent statutory authority responsible for the assessment, registration and regulation of agricultural and veterinary chemicals (generally referred to as pesticides and veterinary medicines) in Australia. We administer and manage the National Registration Scheme for Agricultural and Veterinary Chemicals, which sets out the regulatory framework for managing these chemicals in Australia. The APVMA sits within the portfolio of the Minister for Agriculture, the Hon. Barnaby Joyce MP.
More than 11 000 pesticide or veterinary medicine products are registered in Australia. Australia's system for managing pesticides and veterinary medicines is a risk management system that provides a systematic, scientific, evidence-based approach to decision-making and operations.
We evaluate the safety and performance of chemicals intended for sale in Australia to ensure that the health and safety of people, animals, crops and the environment are protected. Also, registered products must not unduly jeopardise Australia's trade with other countries.
Our work supports primary industries—agriculture, forestry, horticulture and aquaculture—by allowing the supply of safe, effective animal health and crop protection products. Our work also supports consumers by ensuring that household and garden pesticides and pet products are safe and effective.
Our role extends beyond registration of pesticides and veterinary medicines. We license and audit veterinary manufacturers to ensure adherence to APVMA-prescribed manufacturing standards. We manage an Adverse Experience Reporting Program that is designed to ensure early detection of unforeseen problems with registered chemicals. We also monitor the market for compliance, and review and take regulatory action on registered pesticides and veterinary medicines when concerns are identified.
The APVMA is established under the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act). The Administration Act sets out the role of the APVMA, as an independent statutory authority, for undertaking the responsibilities conferred on it by the states and territories under the National Registration Scheme for Agricultural and Veterinary Chemicals.
APVMA functions and powers are conferred by the Administration Act, the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code Act) and the Agricultural and Veterinary Chemicals Code (Agvet Code), which is set out in a schedule to the Agvet Code Act. The Agvet Code makes provision for the evaluation, registration and control of agricultural chemicals and veterinary medicines, and related matters. In 2013–14, the APVMA implemented a range of reforms introduced through theAgricultural and Veterinary Chemicals Legislation Amendment Act 2013, which will commence on 1 July 2014, to improve the efficiency and effectiveness of these regulatory arrangements.
Functions and powers
The APVMA is responsible for assessing and registering pesticide and veterinary medicine products proposed for supply and use in Australia, and for controlling them up to the point of retail sale. (The states and territories are responsible for regulating and managing the use of pesticides and veterinary medicines once they are sold.)
The functions of the APVMA, set out in s. 7 of the Administration Act, are to:
- assess the suitability for sale in Australia of active constituents for proposed or existing chemical products, registered chemical products, and labels for containers for chemical products
- provide information to the Australian Government and its agencies, and the states and participating territories, about approved active constituents for proposed or existing chemical products, registered chemical products and approved labels for such products, and cooperate with Australian Government agencies on matters relating to the management and control of chemical products
- keep records and statistics of approvals and registrations it has granted, and permits and licences it has issued under the Agvet Code
- evaluate the effects of the use of chemical products in the states and participating territories
- cooperate with the Australian Government and its agencies, and the states and participating territories, to facilitate a consistent approach to the assessment and control of chemicals
- cooperate with the Australian Government and its agencies, and the states and participating territories, to develop codes of practice, standards and guidelines for, and to recommend precautions to be taken in connection with, the manufacture, export, import, sale, handling, possession, storage, disposal and use of chemical products
- collect, interpret, disseminate and publish information relating to chemical products and their use
- encourage and facilitate the application and use of results of evaluation and testing of chemical products
- exchange information relating to chemical products and their use with overseas and international bodies that have similar functions to those of the APVMA
- when requested by the minister, or on its own initiative, report to or advise the minister on any matter relating to chemical products or arising in the course of the performance of the APVMA's functions
- encourage and facilitate the introduction of uniform national procedures for controlling the use of pesticides and veterinary medicines
- fund and cooperate in a program designed to ensure that active constituents for proposed or existing chemical products, registered chemical products and labels for containers for chemical products comply with the Agvet Code, and the Agricultural and Veterinary Chemicals Code Regulations 1995.
In accordance with s. 10 of the Administration Act, the Australian Government minister responsible for administering pesticide and veterinary medicine legislation may direct the APVMA (in writing) in relation to its functions or powers under Australian, state or territory laws. The APVMA must comply with any such direction. No such direction was given in 2013–14.
The APVMA is a cost-recovered agency. Registrants pay application fees to register new products and active constituents, amend a current registration, or apply for a permit. An annual fee is payable each year to renew the registration of a product. Registrants also pay an annual levy based on the sales (and other disposals) of their registered products.
Levies are imposed under the Agricultural and Veterinary Chemical Products Levy Imposition (General) Act 1994, the Agricultural and Veterinary Chemical Products Levy Imposition (Excise) Act 1994 and the Agricultural and Veterinary Chemical Products Levy Imposition (Customs) Act 1994. Levies are collected under the Agricultural and Veterinary Chemical Products (Collection of Levies) Act 1994. Levy rates are prescribed in the Regulations to this Act.
The APVMA's income for 2013–14 was $28.275 million, a decrease of $2.137 million (7.03 per cent) from 2012–13 (see Chapter 4).
Executive management and structure
The APVMA management structure (Figure 1) supports effective operation, communication and strategic understanding at all levels of the organisation.
Figure 1 Organisation structure as at 30 June 2014
The APVMA executive team is responsible for business and compliance performance. It oversees the development of key corporate plans and strategies, monitors and reviews organisational performance and risk, and ensures that the APVMA meets its regulatory obligations. The collective skills and experience of the executive and APVMA staff are used to develop and consider strategic initiatives and operational issues.
The executive leadership team comprises the Chief Executive Officer (CEO), five executive directors and two chief regulatory scientists.
Chief Executive Officer
The CEO is responsible for APVMA governance and management, including the exercise of the APVMA's powers and functions. The CEO consults with the Advisory Board and key stakeholders to set the organisation's vision, objectives and strategies to meet its legislative responsibilities. The CEO approves the APVMA's strategic, financial and operational plans and budgets; monitors financial and operational performance; and oversees program performance. The CEO leads the agency's engagement efforts, particularly its engagement with key international agencies.
Tony de la Fosse BA GradDipHRM MBA GAICD
Executive Director, Corporate Services Program
The Executive Director, Corporate Services Program, manages finance and administration, human resources, information services, public affairs, and information and communication technologies (ICT; including ICT operations and application development). Key responsibilities include providing timely and accurate financial data, and preparing financial plans, budgets and strategies that maximise the APVMA's ability to deliver quality services with the funds available. The position is also responsible for the library, records management, the archive system, risk management and e-commerce.
Stefanie Janiec BCom (Acctg&BusLaw) LLB LLM
General Counsel and Executive Director, Legal and Strategic Coordination Program
The General Counsel and Executive Director, Legal and Strategic Coordination Program, provides and oversees the provision of legal advice and support to the CEO and staff on all aspects of the APVMA's regulatory, administrative and corporate functions. The position also assists in managing legal issues and risks affecting the operation of the APVMA, and facilitates the coordination of advice, briefings and reports regarding policy development, regulatory matters and operational issues from a whole-of-agency perspective for the minister, CEO and broader agency.
Dr Raj Bhula
Executive Director, Pesticides Program
The Executive Director, Pesticides Program, manages the evaluation, registration and review of pesticides. Responsibilities include pesticides chemistry, pesticides residues, chemical review and the Adverse Experience Reporting Program. The position is responsible for determining whether registered chemicals continue to meet contemporary standards, and for continuous improvement of the efficiency and effectiveness of the registration and review processes.
Dr Jan Klaver
Acting Executive Director, Compliance and Regulatory Support Program
The Executive Director, Compliance and Regulatory Support Program, is responsible for ensuring that manufacturers and suppliers of pesticides and veterinary medicines comply with Australian registration requirements up to, and including, the point of retail sale. The position also has responsibility for obtaining scientific assessment services from partner government agencies, engaging with international agencies and supporting the work of the chief regulatory scientists.
Dr Allen Bryce BVSc MVPHMgt MANZCVS GradDipPubSecExecMan CIIBCL
Executive Director, Veterinary Medicines Program
The Executive Director, Veterinary Medicines Program, manages the evaluation, registration and review of veterinary medicines. Responsibilities include registration and granting of permits for use of veterinary medicines; administration of manufacturing quality and licensing systems for veterinary medicines; assessment of veterinary medicines, including veterinary residues, pharmaceutical chemistry, manufacturing quality and licensing; and management of applications and enquiries for pesticides and veterinary medicines. The position is also responsible for ongoing review of existing veterinary products to determine whether they continue to meet contemporary standards, and continuous improvement of the efficiency and effectiveness of the registration and review processes, including adherence to time frames.
Dr Les Davies
Chief Regulatory Scientist, Pesticides
The Chief Regulatory Scientist, Pesticides, is responsible for quality assurance of the pesticides regulatory framework and standards, and for leading the provision of scientific advice on pesticides.
Dr Phil Reeves FANZCVS
Chief Regulatory Scientist, Veterinary Medicines
The Chief Regulatory Scientist, Veterinary Medicines, is responsible for quality assurance of the veterinary medicines regulatory framework and standards, and for leading the provision of scientific advice on veterinary medicines and nanotechnology.