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AgVetLink April 2004: Page 7

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OECD

John Reeve, Programme Manager (Toxicology and Residues), attended the OECD pesticides meetings in February. The highlight of the meetings was the adoption of the ten-year vision for the harmonisation of data requirements and regulatory reviews of pesticides.

The aim is to achieve a single review of the data package on a pesticide, which will be picked up by other OECD countries and used for their regulatory purposes without the need to do the review work – the ultimate in work sharing and efficient use of expert resources.

Toxicology assessors

While in Europe, John visited the University of Surrey to interview students wanting to come and work for ERMA New Zealand and the ACVM Group as toxicology assessors during their professional training year. Two students are required for the 2004/5 year, to replace Steven Johnstone (currently working with ERMA New Zealand) and Richard Dickson-Lowe (working with the ACVM Group). Sion Guy was chosen for ERMA New Zealand, and Andrew Pearson for the ACVM Group.

The employment of Surrey University students has proven to be a valuable resource for the ACVM Group. Andrew will be the eighth student to come and learn the art of regulatory toxicology with us, while doing very useful work in processing appropriate parts of registration applications, MRL setting and adding substances to the GRAS lists.

International Visitors

APVMA visit

Trevor Doust, Chemistry and Residues Program Manager for the APVMA, visited the ACVM Group on 23 February. He gave a general update on pesticides and veterinary medicines to the entire Group and met with smaller groups for more technical discussions.

Topics covered included:

• New chemistry standard for technical grade active constituents (TGACs)

• Stability requirements

• Cross-referencing rules

• Progress with the APVMA’s minor use programme, which was kick-started with the meeting in November and has significant APVMA Board support

• Possibility of mutual recognition of data assessments for chemistry and residues

• Residues (progress in Australia on GLP for field trials)

• Progress with the fipronil/CCA reviews

• New data protection rules for APVMA.

The APVMA’s adverse event reporting for pesticides, which just started in January, was also discussed. They have had a reporting system for veterinary medicines in place for some time, and much of their compliance work comes from this, e.g. fipronil.

VMD visit

The March visit by the Chief Inspector of the VMD, Dr Jason Todd, was the second of two planned visits to align the process of the ACVM Group with that of the VMD in carrying out Quality Assurance/ Quality Control (QA/QC) inspections.

These inspections focus on the quality systems of companies manufacturing veterinary vaccines and are used to enable official batch release by the VMD of veterinary biological products into the market in the UK. The VMD has visited New Zealand exporters of these products to the UK on an annual basis.

As a result of a two-year programme of collaborative inspections, the ACVM Group will perform QA/QC inspections on behalf of the VMD under a technical agreement that is being developed between the ACVM Group and the VMD. This will reduce the cost of compliance with UK requirements for exporters into the UK.

 

Hui on 1080

Warren Hughes, Senior Advisor (Approvals), attended a Hui regarding 1080 in Whakatane on 20 and 21 February 2004. The Hui was organised by Landcare Research and was intended to provide a neutral environment and allow participation of Maori to discuss issues over the use of 1080. A number of stakeholders were present and were given the opportunity to express their views on 1080 use.

The ACVM Group was one of the stakeholders asked to provide a short presentation. It covered historical and current regulatory requirements on the registration of vertebrate toxic agents.

While the Hui did not resolve issues, it did allow stakeholders to present their views in a relaxed environment. It also showed that the community needed more information and consultation over the use of 1080, particularly aerial applications.