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Pesticides – fodder cereals

The ACVM Group understands there is a move towards growing cereals for fodder rather than for grain. This change is due to the increase in dairy farms in the South Island where farmers are looking to maximise stocking rates and hedge against potential feed shortages.

Proprietors of registered pesticides (particularly fungicides) with a label claim to use on cereals are reminded that the cereal withholding period for such products is based on cereals grown for grain. No residue assessment has been undertaken on whether such a withholding period is acceptable for cereals grown for fodder. In addition, in a number of instances, the current withholding period is not good agricultural practice (GAP) for fodder cereals.

The ACVM Group has sought advice on GAP withholding periods for fodder cereals. Based on this advice, it appears a 28 day withholding period would equate to GAP for this use. Products will be required to show two withholding periods: one for cereals grown for grain and the other for cereals grown for fodder.

Consequently, before proprietors of these products recommend use of their products on fodder cereals, they must have them approved by the ACVM Group. Such applications would fall into the application type C8 (change in withholding period). Appropriate data sets and/or scientific arguments should accompany the application.

Update: Mutual Recognition Agreement for Good Manufacturing Practice with EC

Both MAF and the European Medicines Evaluation Agency (EMEA) for the European Community (EC) continue their commitment to complete the transitional period for the implementation of the mutual recognition agreement (MRA) on the assessment of GMP at the end of December 2001. Brian Pidford visited the Veterinary Medicines Directorate (VMD), the Medicines Control Agency (MCA) and the EMEA in October to prepare for the completion of the final stage of the transition.

Under the agreement, GMP inspections of manufacturers of veterinary vaccines and veterinary pharmaceuticals exporting products to the EC that are carried out for the ACVM Group will be accepted by the EMEA for the member states of the EC. European inspectors will no longer visit New Zealand to carry out GMP inspections for these manufacturers.

However, one type of inspection remains outside the agreement and this has been a concern to manufacturers of veterinary vaccines. Veterinary vaccines are subject to Official Batch Release in the EC. Under the Official Batch Release process there are provisions for each batch to be sampled and tested by a government laboratory prior to release to the market.

These provisions have been  implemented in a variety of ways by member states and there is no harmonised system for Official Batch Release. The UK approach has been for the VMD to introduce a different inspection process called a QA/QC inspection to replace sampling and testing of individual batches of veterinary vaccines. Under the MRA, visits were expected to continue by the VMD inspector to conduct QA/ QC inspections for Official Batch Release.

Agreement with the VMD was reached that, in principle, the VMD could accept New Zealand conducted QA/QC inspections for Official Batch Release until the European system becomes a harmonised one. It was agreed that a transition, separate from the MRA GMP transition, would probably be required for transfer of expertise and assurance of equivalence. The VMD meanwhile would be extending the interval between QA/QC inspections out to 18 months. It was also agreed that the next VMD inspection (probably in late 2002) should be used for training and evaluation of New Zealand QA/ QC inspections.

Arrangements were concluded for the observation of GMP inspection in New Zealand by an inspector for the EMEA. This visit took place in October and work is continuing on the reports and follow up from that process.

A presentation on the New Zealand GMP process was given to a meeting of European GMP inspectors at the EMEA. Another meeting at the EMEA dealt with issues identified by a report prepared for the EMEA on equivalence between New Zealand and EC legislation to control veterinary medicines.

In late December, Katrin Nodop, Principal Administrator, EMEA, will visit New Zealand and we shall complete a joint report to the Joint Committee for the MRA recommending the signing of the agreement for veterinary medicines. In addition, final documentation will be agreed and the format of the MRA maintenance programme will be developed.