• Appendices
• Appendix A: The APVMA's Advisory Board and Audit Committee
• Appendix B: Product application categories and product application performance
• Appendix C: Committees
• Appendix D: Freedom of Information
• Appendix E: Consultancies
• Appendix F: Corrections to 2008-09 APVMA Annual Report

Community Consultative Committee

The APVMA Community Consultative Committee (CCC) provides a direct link for effective two-way communication between the national chemical regulator and community representatives with an interest in the way pesticides and veterinary medicines are regulated. The committee addresses issues raised by the community, and those referred by the APVMA, of matters relating to agvet chemicals and reporting on the effects on the community of the use or misuse of agvet chemicals.

For the APVMA to operate to best effect, it is vital that current and emerging issues of interest and concern that the community has with the regulation of these chemicals are taken into account. It is equally important that the community be kept fully informed on the rationale that underpins regulatory decisions. The CCC also provides a valuable means for the dissemination of information on such key issues back to the community.

While the regulation of pesticides and veterinary medicines can give rise to some contentious issues, the CCC operates in an atmosphere of shared respect for the different points of view represented in its membership and an acknowledgement of scientific fact as the legitimate basis for decision-making.

Terms of reference

The CCC’s terms of reference require it to:

• communicate community views to the APVMA on a range of issues about pesticides and veterinary medicines
• encourage informed community debate by conveying information from the APVMA to community networks and explaining the operations and processes of the APVMA to the community
• convey community concerns to the APVMA about pesticides and veterinary medicines
• recommend to the APVMA further work that might be undertaken to resolve issues of community concern relating to the registration of pesticides and veterinary medicines
• advise on matters referred to it by the APVMA.

Membership and attendance

The committee met in Canberra four times in 2009-10 (September and December 2009 and March and June 2010). Attendance at CCC meetings is shown in Table C-1.

Dr Raj Bhula was the APVMA’s executive advisor to the committee.

Table C-1: Membership and attendance at Community Consultative Committee meetings

Member	Organisation	Meetings attended	Meetings eligible to attend
Dr Heather Yeatman (Chair)	Public Health Association of Australia	4	4
Mr Peter Cone	National Farmers’ Federation	4	4
Mr Neville Prowse-Brown	Australian Landscape Trust, East Gippsland Landcare Network, Victorian Farmers Federation East Gippsland District Council	4	4
Ms Heather Wieland	Country Women’s Association of Australia	3	3
Mr John Temperley	Farmsafe Australia Inc	4	4
Mr Joe Elbustani	Greenhouse Vegetables Association, NSW Farmers Association	3	4
Mr Anthony Amis	Friends of the Earth	4	4
Mr David Lawson	Consumers Federation of Australia	4	4

Issues considered

Significant achievements for the CCC in 2009-10 were:

• continued work on advancing the emerging issues project in agvet chemical regulation
• completion of work with the APVMA to provide an emerging issues link on the APVMA website in the form of ‘Chemicals in the News’ and ‘Community Questions’
• continued work on the current educational requirements around agvet use
• a submission to the Product Safety and Integrity Committee to raise the education and information provision role in relation to the review of a single national framework.

The committee also received several presentations from the APVMA and industry members on spray drift risk assessment for human health and on the globally harmonised system on chemical labelling.

Declarations of Interest

There were no matters declared by any member of the CCC that would give rise to any personal, material conflict of interest. Records of declarations are maintained by the APVMA.

Industry Liaison Committee

The Industry Liaison Committee (ILC) is the main consultative forum for the APVMA and peak chemical industry organisations representing registrants of agvet chemicals. The committee is used to promote active engagement of key industry stakeholders in the strategic planning process, operational issues and associated reforms developed by the APVMA in its role as manager of the National Registration Scheme.

The ILC operates as a mechanism for industry, through peak chemical industry bodies, to provide input APVMA’s corporate planning activities, including consideration of current or emerging strategic issues and provide a forum for formal consultation on APVMA operating policies and programs. The ILC offers a vehicle to enhance co-operation between industry and APVMA.

Terms of reference

The ILC’s terms of reference are to:

• obtain the views of industry members on issues of a strategic nature
• provide industry input to APVMA corporate planning processes
• identify opportunities for regulatory reform within the existing framework
• provide a forum for the exchange of information including performance and expectations
• address specific operating policy issues through working groups
• consider the impact of proposed macro-policy changes on APVMA operations and implications for industry.

Membership and attendance

The committee met three times in Canberra during 2009-10 (August and November 2009 and April 2010). Attendance at ILC meetings is shown in Table C-2.

Table C-2: Membership of and attendance at Industry Liaison Committee meetings

Member	Organisation	Meetings attended	Meetings eligible to attend
Dr Eva Bennet-Jenkins (Chair)	Australian Pesticides and Veterinary Medicines Authority	3	3
Ms Kathy Nolan Ms Dusanka Sabic	ACCORD Australasia	2 3	3 3
Mr Lindsay Showyin Dr Philip Fleming	Aerosol Association of Australia Inc.	3 3	3 3
Dr Peter Holdsworth	Animal Health Alliance (Australia) Ltd	1	3
Ms Paula Matthewson Dr Adrian Harris Mr Ben Stapley	CropLife Australia	3 2 1	3 2 1
Mr John Firth	Generic Agricultural Chemical Association	1	3
Mr Kevin Bodnaruk	Nursery and Garden Industry Australia	1	3
Mr Bernard Lee Geoff MacAlpine	Plastics and Chemicals Industries Association	1 3	3 3
Mr Spiros Dassakis	Swimming Pool and Spa Association of Australia	1	3
Mr Robert Schufft Mr Ian Saunders	The Veterinary Manufacturers and Distributors Association Ltd	3 2	3 3

Issues considered

Issues before the ILC included:

• regulatory compliance relating to compounding pharmacies
• Freedom of Information reforms
• insecticide mode of action classification
• compliance reforms
• input into the 2010-11 Operational Plan
• management of the ILC’s working groups and the future role of ITC
• World Association for the Advancement of Veterinary Parasitology ectoparasiticide guidelines
• input into review of the agvet chemicals framework
• the National Registration Scheme and the APVMA’s role in education
• the review of application screening processes
• operational policy on research permits
• ILC Key Performance Indicators.

The committee also received presentations from several state government departments on control of use regulation and the single national framework for agvet chemicals, as well as presentations on procedures taken up by the APVMA to improve internal processes.

Declarations of Interest

There were no matters declared by any member of the ILC that would give rise to any personal, material conflict of interest. Records of declarations are maintained by the APVMA.

Industry Technical Committee

The Industry Technical Committee (ITC) supports the Industry Liaison Committee (ILC) by addressing specific technical issues affecting regulatory policy, programs and performance. The committee is sought to improve the functioning of the ILC, both for industry and the APVMA by dealing with specific technical issues and provide a forum for peak industry and from specialist scientific and technical bodies to progress technical, administrative and other relevant issues.

Membership of the ITC is drawn from industry groups represented on the ILC and from other specialist scientific and technical groups.

The ITC has been discontinued, as noted earlier in the report (see page 41). The industry stakeholders represented will be invited to join ILC and the working groups that previously reported through the ITC to the ILC will now report directly to ILC.

Terms of reference

The committee’s terms of reference were to:

• address specific technical issues through working groups, which should be led by an industry representative where possible
• provide technical input to APVMA guidelines, standards, operating procedures and publications for the assessment of agvet chemicals prior to their release for public consultation
• consider matters relating to the technical work of the APVMA.

Membership and attendance

The committee met twice 10 (September 2009 and February 2010). Attendance at ITC meetings is shown in Table C-3.

Table C-3: Membership of and attendance at Industry Technical Committee meetings

Member	Organisation	Meetings attended	Meetings eligible to attend
Dr Allen Bryce (chair)	Australian Pesticides and Veterinary Medicines Authority	2	2
Ms Kathy Nolan Ms Catherine Oh	ACCORD Australia	2 1	2 2
Dr Philip Fleming	Aerosol Association of Australia	0	2
Mr Richard Phillips	Australian Paint Manufacturers’ Federation	2	2
Vacant	Australian Racing Board	0	2
Dr Kim Agnew	Australian Veterinarians in Industry	1	2
Dr Bruce Twentyman	Australian Veterinary Association	1	2
Dr Peter Holdsworth	Animal Health Alliance (Australia) Ltd	2	2
Dr Adrian Harris	CropLife Australia	2	2
Dr Kevin Bodnaruk	Horticulture Australia Limited	1	2
Dr Roger Bektash	Pet Food Industry Association of Australia	2	2
Ms Stephanie Leach	Plastics and Chemicals Industries Association	2	2
Mr Ian Saunders Mr Robert Schufft	The Veterinary Manufacturers and Distributors Association	1 2	2 2

Issues considered

Issues before the ITC in 2009–10 included:

• reports of ITC working groups and consultation
• the APVMA’s Adverse Experience Reporting Program
• register of APVMA requirements, guidelines and operational policies under development
• regulation of compounding pharmacies
• cascade system for veterinary prescribing
• MORAG Guidelines 47 and 49
• veterinary immunobiological products stability guidelines
• cuprous oxide standards
• implementation of the Globally Harmonised System of Labelling
• options for modes of engagement with the APVMA
• an Animal Health Alliance (Australasia) proposal for increasing efficiencies without compromising risk assessment in respect of changes to manufacturing licences and particulars.

Declarations of Interest

There were no matters declared by any of the ITC that would give rise to any personal, material conflict of interest. Records of declarations are maintained by the APVMA.

Manufacturers’ Licensing Scheme Industry Liaison Committee

The APVMA established the Manufacturers’ Licensing Scheme Industry Liaison Committee (MLSILC) to provide a forum to discuss strategic and operational issues related to the Manufacturers’ Licensing Scheme (MLS) and the Overseas GMP Scheme with industry representatives and auditors.

Terms of reference

The committee was created to promote active engagement of key stakeholders by:
obtaining the views of industry members and auditors on issues of an operational, technical or strategic nature
advancing the development and review of operating procedures, manufacturing standards and guidelines relevant to the MLS
providing industry input into APVMA operational planning processes related to manufacturing issues
identifying opportunities for regulatory reform within the existing framework
considering the impact of proposed policy changes on APVMA operations and implications for industry
facilitating communication with industry and other stakeholders.

Membership and attendance

The committee met four times (in July and October 2009 and in January and April 2010). Attendance at committee meetings is shown in Table C-4.
Table C-4 Membership and attendance at Manufacturers’ Licensing Scheme Industry Liaison Committee meetings

Member	Organisation	Meetings attended	Meetings eligible to attend
Dr Bruce Johnson (Chair)	Australian Pesticides and Veterinary Medicines Authority	4	4
Mrs Kathryn Winterton		4	4
Ms Michelle Elliot (Secretary, Jul 09)		1	1
Ms Rheannon McNeil (Secretary, Oct 09)		1	1
Ms Dounia Houzaife (Secretary, Jan and Jun 10		2	2
Mr Andrew Duncum	Animal Health Alliance (Australia) Ltd	2	4
Dr Peter Holdsworth (Jun 09)		1	3
Mr Neil Sammons (Dec 09 to		2	3
Mr Ian Wheatley	Auditors’ representative	4	4
Mr Bill Blackhall	The Veterinary Manufacturers and Distributors Association	4	4

Issues Considered

Issues considered during 2008–09 included:
progress with auditing and licensing of veterinary medicine product manufacturers
feedback from manufacturers on the audit process
memorandum of understanding between APVMA and the TGA
planned appointment of additional APVMA GMP auditors
various GMP issues, including: stability testing requirements; licensing requirements for warehouses/storage; requirements for change of site of manufacture
raising awareness of enforcement activity in relation to licensing breaches
progress with the Overseas GMP Scheme
various Overseas GMP issues, including requirement to maintain evidence of GMP compliance and the auditing of overseas sites
operation and management of mutual recognition agreements, including report of APVMA staff member’s visit to European Medicines Agency, London, in February-March 2010
compounding pharmacies
2010 Auditors Workshop.

Registration Liaison Committee

The Registration Liaison Committee (RLC) is the main consultative forum for the APVMA, representatives of the state and territory signatories to the National Registration Scheme and other relevant Australian government agencies.
The purpose of the RLC is to provide a forum for the development and operational coordination of the National Registration Scheme and for consultation on the development of operational policies, guidelines and protocols in both the APVMA and the signatory organisations. The aim is to allow effective alignment of the pesticide and veterinary medicines control objectives of the APVMA and states and territories.

Terms of reference

The terms of reference of the RLC are to:
align the outputs of the APVMA’s registration processes and the chemical management objectives of the states and territories
develop operational policies for the operation of the National Registration Scheme, including those dealing with registration (including labelling), regulation and appropriate use of agricultural and veterinary chemicals
provide feedback on state and territory views on these issues and particularly their impact on chemical users and the responsibilities of regulators
address specific operating policy issues as necessary

• provide input to operational planning priorities
• provide input to existing chemical review priorities.

Membership and attendance

Formal meetings of the RLC were held in Canberra in September 2009 and March 2010, and twice more by teleconference (November 2009 and June 2010). Attendance at RLC meetings is shown in Table C-5.
Table C-5 Membership and attendance at Registration Liaison Committee meetings and teleconferences

Issues considered

Issues considered by RLC included:

• progress with auditing and licensing of veterinary medicine product manufacturers
• feedback from manufacturers on the audit process
• memorandum of understanding between APVMA and the TGA
• planned appointment of additional APVMA GMP auditors
• various GMP issues, including: stability testing requirements; licensing requirements for warehouses/storage; requirements for change of site of manufacture
• raising awareness of enforcement activity in relation to licensing breaches
• progress with the Overseas GMP Scheme
• various Overseas GMP issues, including requirement to maintain evidence of GMP compliance and the auditing overseas sites
• operation and management of mutual recognition agreements, including report of APVMA staff member’s visit to European Medicines Agency, London, in February-March 2010
• compounding pharmacies
• 2010 Auditors Workshop.

Declarations of Interest

There were no matters declared by any of the RLC that would give rise to any personal, material conflict of interest. Records of declarations are maintained by the APVMA.

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