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Annual Report 2016–17—Chapter 2: Organisation overview
Corporate profile and purpose
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the independent statutory authority responsible for the assessment, registration and regulation of agricultural and veterinary (agvet) chemicals in Australia.
Agvet chemical products must be evaluated and registered by the APVMA before they can?be legally sold, supplied or used in Australia.
More than 11?480 pesticide and veterinary medicine products are currently registered in Australia, including products for treating crop and garden diseases and pests, and medicines for treating agricultural and companion animals.
The APVMA takes 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 protect the health and safety of people, animals, crops and the environment. Registered products must also not jeopardise Australia’s trade with other countries.
Our work supports primary industries—agriculture, forestry, horticulture and aquaculture —by allowing the supply of safe and effective animal health and crop protection products. Our work supports consumers by ensuring that household and garden pesticides and pet products are safe to use.
Our role extends beyond registration of agricultural chemicals and veterinary medicines to encompass a range of activities aimed at protecting Australians, and ensuring that products are safe. We license and audit veterinary manufacturers to ensure that they adhere to APVMA-prescribed manufacturing standards. We manage the APVMA Adverse Experience Reporting Program to ensure early detection of unforeseen problems with registered chemicals. We monitor the market for compliance, and review and take regulatory action on?registered pesticides and veterinary medicines when concerns are raised.
The APVMA is a portfolio agency of the Deputy Prime Minister and Minister for Agriculture and Water Resources, the Hon.?Barnaby Joyce MP.
The APVMA is established under the?Agricultural and Veterinary Chemicals (Administration) Act 1992?(Administration Act). The Administration Act sets out the APVMA’s role to administer the National Registration Scheme for Agricultural and Veterinary Chemicals, and the scheme’s legislation, in partnership with state and territory governments.
Functions and powers are conferred on the APVMA by the Administration Act, the Agricultural and Veterinary Chemicals Code (Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) and the Agvet Codes and Agvet Regulations of?each state or participating territory.
The APVMA is a corporate Commonwealth entity under the Public Governance, Performance and Accountability Act 2013 (PGPA Act). A corporate Commonwealth entity is a corporate body that is legally separate from the Commonwealth.
Functions and powers
The APVMA operates under an Intergovernmental agreement between the Commonwealth Government and all states and territories. Under this agreement, the APVMA is responsible for regulating agvet chemicals up to and including the point of sale. The?states?and territories are responsible for regulating agvet chemicals after they are?sold, a?process known as ‘control of use’. The APVMA does not have responsibility for?monitoring how chemicals are used.
The key 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
- ensure that approvals and registrations for active constituents for chemical products, chemical products and labels for containers for chemical products comply with the Agvet Code and the Agvet Code Regulations
- provide information to the Australian Government and its agencies, and the states and territories, about approved active constituents for proposed or existing chemical products, registered chemical products and approved labels for such products, and cooperate with the Australian Government and its agencies on matters relating to the?management and control of chemical products
- collect and publish relevant information and statistics on approvals and registrations granted, and permits and licences issued under the Agvet Code
- with the Australian Government and its agencies, and the states and participating territories, facilitate a consistent approach to the assessment and control of agvet?chemicals
- exchange information relating to chemical products and their use, with overseas and?international bodies that have similar functions to those of the APVMA
- report to or advise the minister on matters relating to the performance of the APVMA’s?functions.
Under s.?10 of the Administration Act, the Australian Government minister responsible for?administering agvet medicine legislation may direct the APVMA (in writing) concerning its functions or powers under Australian, state or territory laws. The APVMA must comply with any such direction. No such direction was given in 2016–17.
Executive management and structure
The APVMA management structure (Figure?1) supports effective operation, communication and strategic understanding at all levels of the organisation.
|Chief Executive Officer||Office of the Chief Executive Officer|
and Chemical Review
|?||Chemistry and Manufacture|
|?||Residues and Trade|
|?||Efficacy Assessment Coordinator|
|?||Scientific Standards and Data Guidelines|
|Case Management and Administration|
|?||Quality Oversight and Reporting|
|?||Human Resources and Development|
|?||Procurement and Partnership Management|
|?||Public Affairs and Communication|
|?||Information and Communication Technology|
|Legal and Compliance||Legal|
|?||Compliance and Monitoring|
|?||Manufacturing Quality and Licensing|
|Office of the Chief Scientist||Principal Scientist|
Figure 1: APVMA management structure as at 30?June 2017
The APVMA Executive Leadership Team is responsible for business performance and managing agency compliance with legislative requirements. It oversees the development of key corporate plans and strategies, monitors and reviews organisational performance and risk, and ensures that we meet our regulatory obligations. The executive team and APVMA staff use their collective skills and experience to develop and consider strategic initiatives and operational issues.
Dr Chris Parker
Interim Chief Executive Officer
The Chief Executive Officer (CEO) is responsible for APVMA governance and management, including the exercise of the APVMA’s powers and functions. The CEO consults with key stakeholders to set the organisation’s vision, objectives and strategies to meet its legislative responsibilities. The CEO approves the APVMA’s corporate 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. In May 2017, Kareena Arthy resigned as APVMA CEO and Dr?Chris Parker was appointed in?June 2017 as interim CEO
Ms Stefanie Janiec
Chief Operating Officer
The Chief Operating Officer (COO) manages finance and administration, human resources, public affairs and communication, information management and technology, procurement and partnership management, business systems and organisational performance analysis. Key responsibilities include providing timely and accurate financial data and preparing financial plans, budgets and strategies that support the APVMA’s ability to deliver quality services with the funds available. The COO oversees information technology (IT) operations, security, information services and application development, people services including recruitment and retention of staff, work health and safety (WHS), staff wellbeing, learning and development and workplace relations, risk management, records management, physical and personnel security, and e-commerce
The COO oversees all corporate and relocation-related services to ensure the relocation happens with as little disruption as possible. Two new executive directors were established to support the COO with management of the relocation.
Mr Mitchell Levy
Executive Director, Digital Strategy
The Executive Director (ED), Digital Strategy is responsible for ensuring that the APVMA Digital strategy is designed and delivered to underpin the business model in Armidale, including overseeing the linkages to established business systems and the transition from the existing system to the new platforms. The ED Digital Strategy heads two teams: business systems—focusing on sustaining the business in Canberra; and Armidale systems—focusing on the new digital strategy for the transition and relocation of the APVMA from Canberra to Armidale.
Mr Paul Kruspe
Executive Director, Relocation Operations
The ED Relocation Operations is responsible for the overall planning, scheduling and delivery of the logistics of the relocation, as well as ensuring appropriate risk management, procurement, governance and record keeping arrangements are in place. The ED Relocation Operations heads four?teams: planning, scheduling and coordination; procurement, contracts and record management; governance, risk and reporting; and staff liaison.
Dr Jason Lutze
Acting Executive Director, Scientific Assessment and Chemical Review
The ED Scientific Assessment and Chemical Review manages the expert assessment areas of the APVMA and the Chemical Review Program. This includes the chemistry and manufacture, health assessment and residues teams and the assessment oordinators for environment and efficacy. Responsibilities also include determining whether registered chemicals continue to meet contemporary standards, and continuously improving data guidelines and the quality of the assessments contributing to registration and review processes.
Mr Alan Norden
Executive Director, Registration Management and Evaluation
The ED Registration Management and Evaluation manages the overall registration process for agvet chemicals and veterinary medicines. Responsibilities include managing pre-application assistance (PAA), preliminary assessment of applications and the evaluation process. Responsibilities also include granting permits for minor uses, emergencies and research purposes and issuing export certificates and import consents.
Ms Geetha Nair
Acting Executive Director, Legal and Compliance, and General Counsel
The ED Legal and Compliance, and General Counsel provides and oversees the provision of legal advice, compliance and licensing activities and support to the CEO and staff on all aspects of the APVMA’s regulatory, administrative and corporate functions. Responsibilities include provision of high-level and strategic legal advice, particularly on significant issues that may have agency-wide implications, and delivering the APVMA’s compliance and licensing operations. Ms?Geetha Nair has come to APVMA on secondment from the Australian Government Solicitor.
Dr Phil Reeves
The Chief Scientist ensures that the APVMA’s regulatory science frameworks and standards meet appropriate national and international standards. Through engagement with national and international scientific and regulatory networks, the Chief Scientist identifies issues and trends that may affect the integrity of these frameworks and standards, and develops appropriate projects and initiatives to improve the APVMA’s scientific capability. Responsibilities also include providing the CEO and senior staff with?independent, expert advice on regulatory decisions and scientific?aspects of the APVMA’s regulatory framework, and managing the APVMA’s Office of the Chief Scientist.
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 to renew the registration of a product. Product owners also pay?an annual levy based on the sales 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 Levy) Act 1994, and the levy rates are prescribed in the Regulations to the Act.
The APVMA’s industry income for 2016–17 was $30.119?million, an increase of $0.604?million (2?per?cent) from 2015–16. Other available income was an interest equivalency of $0.588?million, and $0.099?million relating to Food Standards Australia New Zealand, giving a total of $30.806?million. This income funded APVMA’s business-as-usual activities and excludes appropriation funding relating to the Agricultural?Competitiveness White Paper reform initiatives and APVMA’s relocation activities to Armidale, NSW.
The APVMA’s industry-related expenses for 2016–17 were $34.097?million, excluding expenses related to the White Paper reforms and relocation appropriation.
The APVMA’s total income for 2016–17 was $35.055?million, an increase of $4.616?million (13?per?cent) compared with 2015–16. The APVMA’s total expenses for?2016–17 were $36.216 million, an increase of $2.361 million (6 per cent) compared with?2015–16. This has resulted in a deficit for 2016–17 of $1.161 million.
The net cost of APVMA services for 2016–17 was $35.824?million.
The inclusion of White Paper reform and Armidale relocation carry over funding has resulted in an equity balance of $6.798 million, which is 3 per cent below the APVMA’s preferred equity position of $7.000 million.
Significant noncompliance issues with finance law
No issues were reported to the Minister for Agriculture and Water Resources under paragraph?19(1)(e) of the PGPA Act that related to noncompliance with the finance law in?relation to the entity
Table?1 provides details of Australian Public Service (APS) employees employed at the APVMA under the Public Service Act 1999 in 2016–17.
We had 173 full-time and part-time ongoing staff at 30?June 2017. There were also 44 non-ongoing or casual staff, bringing the total number of staff to 217 (133?female, 84?male). No staff identify as being Indigenous. Staff are located in Canberra, other than one staff member who is in Perth.
In 2016–17, the separation rate for ongoing staff was 23.7?per?cent, which is an increase from the 18.7?per?cent separation rate in the previous year.
Table 1: APVMA staffing, at 30?June 2017
|Senior Executive Officer||3||0||2||5|
APS?=?Australian Public Service; CEO?=?Chief Executive Officer; EL?=?executive level
Ministerial directions and government policy?orders
A GPO was made under s.?22 of the PGPA Act.
The GPO specified that corporate Commonwealth entities with agricultural policy or regulatory responsibilities are to be located in a regional community that is near a main?campus of a regional university recognised for research and teaching in the field of?agricultural science. The GPO applies to the APVMA.
Significant activities and changes
The issuing of the GPO to relocate the APVMA has provided the agency with the opportunity to think strategically about how we improve and modernise our business as?a?world-class regulator operating from regional Australia.
In 2016–17, the APVMA focused on the planning phase of the relocation. The agency opened an interim office in Armidale, and plans are underway for the permanent building to be available by mid-2019. Extensive work is being undertaken to design an appropriate business model for the future APVMA as well as the implementation of a digital strategy to?increase efficiency and accommodate remote workers.
The APVMA has established an APVMA Relocation Advisory Committee with staff and representatives from peak bodies as members. Through this committee, our stakeholders will be able to advise the CEO on the relocation, business model and digital strategy. We are committed to continued collaboration with industry as we build and establish our?operations in Armidale.
“We are committed to continued?
collaboration with industry
as we build and establish
our operations in Armidale.”