Key outcomes of the APVMA Board of Directors - Meeting APVMA 13, April 2005

CHEMICAL REVIEWS

Carbon Disulfide

Following voluntary cancellation of registration of a grain fumigant product containing carbon disulfide in December 2004, the review has continued for the only remaining carbon disulfide product, C.S.S.P. Phosphorus Pig Poison (41130).

The Board endorsed the review findings for the pig poison product, noting that the scope of APVMA considerations does not include animal humaneness. It was agreed to release the Review Findings report. The decisions will require product registrants to submit new product labels for approval that include comprehensive information relating to distance restrictions, neighbour notification, disposal of baits and carcasses at the end of a baiting campaign and placement of poison signs (consistent with a permit for use in NSW), updated first aid instructions and safety directions, and clearer directions for the amount of product to be applied.

It is anticipated that the report will be released in May 2005.

Methiocarb

The Board considered the Preliminary Review Findings and proposed regulatory actions pertaining to the active constituent methiocarb, product registrations containing methiocarb and associated label approvals.

The proposed outcomes of the review are that labels be varied to remove all use patterns in food and animal feed producing crops, because of a lack of residues data, and to remove soil drench uses for ornamentals, because of concerns over worker safety. In addition, labels were found to contain inadequate instructions and the following variations were proposed:

· revised safety directions and warning statements
· new instructions in relation to personal protective equipment and re-entry to treated crops
· new instructions in relation to environmental protection.

The Board agreed to release the report with some further refinements for public comment for a period of 3 months. It is anticipated that the report will be released in early May 2005.

Procymidone

In November 2004, the Board suspended the registrations and label approvals for products containing procymidone and placed all affected products and labels under review. The decision took account of advice received from the Office of Chemical Safety concerning human health and occupational health and safety.

Since the Board’s decision, registrants have voluntarily cooperated with the APVMA to ensure that new instructions for use appear on labels still in the market. Several applications have been received for approval of updated labels consistent with those instructions.

The Board noted that approved updated labels will be added to the current review of procymidone and will be subject to the review outcomes.

Other Review Matters

The Board also noted:

· an update on the review of diuron
· that the principal registrant, Phibro Animal Health, has sought review by the Administrative Appeals Tribunal of the outcomes of the virginiamycin review.

OTHER OUTCOMES

Cost Recovery

The Board was advised that the Agricultural and Veterinary Chemicals Legislation Amendment (Levy and Fees) Act 2005 received Royal Assent on 1 April 2005. The Board noted that drafting of the associated regulatory amendments is proceeding and that the Regulations are expected to be tabled during May.

The Board also noted progress towards revising the APVMA’s Agricultural and Veterinary Requirements Series. The revisions are necessary to reflect consolidation and re-definition of application categories associated with the new cost recovery arrangements. The revised requirements to be known as the ‘Manual of Requirements and Guidelines’ (MORAG) will commence along with the new fee structure on 1 July 2005.

The Board also noted and welcomed a proposed performance audit of the APVMA and believed that it would assist in addressing questions and perceptions that have been raised by some industry organisations during consideration of the new fees legislation.

2005 – 2006 Budget

Following review and endorsement by the Board Audit Committee, the Board reviewed and approved the following budget for 2005 – 2006:

· Revenue $24.934 million
· Expenditure $23.117 million
· Net Operating Surplus $1.816 million.

The Board noted that there is considerable uncertainty with the revenue prediction because not all companies have provided sales data for 2004 and assumptions for chemical sales for the first half of 2005 may be impacted further by continuing drought in many areas. The Board was advised that subject to continued improvements in chemical sales in 2005 – 2006 there should be a slightly improved operating outcome for 2005 – 2006. This will be assisted by the APVMA continuing to focus on cost control while at the same time restoring some important activities deferred pending resolution of the fees review.

2005 – 2006 Operational Plan

The Board considered and endorsed the proposed Operational Plan for 2005-06. In continuing to strengthen the initiative of linking planning tools, the Operational Plan has been developed using the Balanced Scorecard (BSC) methodology, which clearly links strategy and actions in all areas of the APVMA to the key corporate goals.

In preparing this Plan, the APVMA has consulted its stakeholders including the agvet chemicals industry through the Industry Liaison Committee.

Review of APVMA Consultative Committees

The Board endorsed a proposed approach for a review of the APVMA’s key consultative committees. The review will assess the appropriateness of current committee objectives, whether those objectives are being met and what changes might be required.

Minor Use Reform

The Board noted that the Minor Use Taskforce met on 30 March and had endorsed a detailed analysis and proposed strategy framework for minor use reform prepared by the APVMA. The Taskforce agreed to present the framework at the next meeting of the Product Safety and Integrity Committee with a view to tabling it with the Primary Industries Standing Committee.

The Board:

· commended the work of the Minor Use Taskforce and progress to date on minor use reforms
· directed that the APVMA assign resources to further develop the strategy framework (including funding options) and to work on securing stakeholder commitment to the proposals.

Registrant and Consumer Awareness

The Board received feedback on work undertaken to monitor the awareness and attitudes of consumers and chemical product registrants. It noted an increasing level of awareness and interest in the regulatory system among consumers and a high level of support for the importance of the APVMA’s role in regulating agricultural chemicals. The APVMA will use the information to assist planning of future enhancements to its operations.

IT Strategic Plan

The Board endorsed the APVMA IT Strategic Plan 2005-2007. The Plan links clearly to addressing priorities set out in the APVMA’s Corporate and Operational Plans.