Key outcomes of the APVMA Board of Directors - Meeting APVMA 15, August 2005

Disclaimer: The website version of APVMA Board meeting outcomes is not a complete or official record of the decisions taken by the APVMA Board and does not provide full details of those decisions. The official record of decisions is contained within the confidential Minutes and Resolutions of each meeting of the APVMA Board of Directors.

CHEMICAL REVIEWS

Carbaryl

The Board considered and endorsed the proposed review findings for carbaryl products registered for use in home garden, home veterinary, poultry and domestic situations.

The APVMA released the draft Carbaryl Review Report for public comment in June 2004 and at the same time required registrants to provide further toxicological and occupational health and safety studies. It was subsequently decided that, owing to emerging complexities unique to broader agricultural uses of carbaryl, the review of carbaryl for those purposes should proceed separately.

Registrants of the affected products will be advised of the proposed review findings and be required to submit product labels that incorporate the specified variations in order for the Board to formally conclude the review.

Methyl Bromide

The Board agreed to formally review products containing methyl bromide and their associated approved product labels. The review relates to Australia’s commitment, as a signatory to The Montreal Protocol on Substances that Deplete the Ozone Layer, to the complete phase-out of methyl bromide, except in specified critical use and quarantine situations.

Australia’s obligations as a signatory to the Montreal Protocol have been managed by the Australian Department of the Environment and Heritage (DEH). The review is proceeding to formally remove uses from the relevant product labels that have already been phased-out in accordance with the Montreal Protocol timetable.

OTHER OUTCOMES

2004-05 Financial Statements

The Board approved the APVMA’s Financial Statements for the year to 30 June 2005, noting that following its audit of the APVMA’s accounts, the Australian National Audit Office has advised that it is in a position to issue an unqualified audit certificate.

2004-05 Annual Report

The Board also approved the content of the draft APVMA 2004-05 Annual Report for presentation to Senator Colbeck for his approval and tabling in Parliament.

Australian Animal Welfare Strategy

The Board received a presentation on the Australian Animal Welfare Strategy from Dr Peter Thornber of the Animal Welfare Unit, Australian Department of Agriculture, Fisheries and Forestry.

Implementation of the Strategy, which is being coordinated nationally by the Animal Welfare Unit, is aimed at strengthening Australia’s animal welfare framework through national legislation, adoption of international best practice standards and with the support of ongoing research, training and education.

Animal Welfare is a topic of considerable interest to the Board. The APVMA will participate in the Australian Animal Welfare Strategy National Implementation Workshop on 22-23 September 2005 and is working to clarify the position of animal welfare considerations in the registration of agricultural and veterinary chemicals.

Review of APVMA Consultative Committees

The Board agreed to release a draft report on the review of APVMA consultative committees for further comment. The review is being conducted as part of the APVMA’s commitment to enhancing transparency.

Regulation Impact Statements

Adoption of the JECFA Approach for Setting MRLs for Veterinary Medicines

The Board endorsed the release of the draft Regulation Impact Statement (RIS) on the proposed Adoption of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Approach for Setting MRLs for Veterinary Medicines. The changes will add rigour to Australian MRL assessments, harmonise methodology more closely with international practice and strengthen Australia’s ability to contribute to and influence international forums. The APVMA has now released the RIS for public consultation until 14 October 2005.

The RIS document can be found at apvma.gov.au/residues/RIS_JECFA.pdf

Revision of Manufacturing Principles and Code of Good Manufacturing Practice for Veterinary Chemical Products

The Board also noted substantial progress toward revising the APVMA Manufacturing Principles and Code of Good Manufacturing Practice for Veterinary Chemical Products. The revisions will clarify APVMA requirements and more closely align those requirements with international standards. The APVMA has received positive feedback and input from Australian veterinary manufacturers. Following clearance by the Office of Regulatory Review, the draft Regulation Impact Statement on the proposed revisions has been released for public consultation until 9 September 2005.

The RIS documentation can be can be found at apvma.gov.au/qa/gmp_codes_drafts.shtml

Implementation of Recommendations from the Galbally Review of Scheduling of Drugs and Poisons

The Board considered options for implementing the Galbally recommendations relevant to the APVMA. Recommendations of interest relate to proposed arrangements for scheduling agricultural and veterinary chemicals and controls over the advertising of Schedule 4 and Schedule 8 veterinary medicines.

South Australian Parliamentary Inquiry into Multiple Chemical Sensitivity (MCS)

The Board discussed the South Australian Parliament’s Social Development Committee report of its inquiry into MCS. Amongst other things, the report makes some recommendations about the need for greater understanding of the relationship between pesticide user and MCS (which is also referred to as Idiopathic Environmental Intolerance (IEI)). While there remains considerable debate within the health community on MCS/IEI, and it is not possible to link cause and effect with people who suffer the symptoms, the Board believes it is important to encourage further research to achieve better understanding to assist chemicals regulators.

Accommodation Options for the APVMA

The APVMA’s leases on its current office accommodation expire in April 2006. The Board considered options for accommodation beyond that. Key considerations are that the outcome is cost effective and that staff can all be accommodated in one building.

Future APVMA Board Meetings

The next and final meeting of the current Board of Directors will be held in Melbourne on 7 October following stakeholder consultations in the Shepparton area on 6 October. The Board’s term expires on 15 October and the first meeting on the new Board is scheduled for 1 December 2005 in Canberra.