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AgVetLink August 2003

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Food residue coordination

Review of EU banned chemicals

The ACVM Group is currently reviewing the registration of a number of veterinary medicines that are still registered for use on food-producing animals in New Zealand, but have been banned in the European Union.

Principally, the anticoccidial drugs containing nitrofuran derivatives are under the spotlight. They have been banned in the EU because they are mutagenic and possibly carcinogenic. Their continued use in New Zealand is based on the fact that they are very rapidly metabolised in the animals for which they are licensed (pigs and poultry), no residues are likely in human foods and, where there is no exposure, the residues cannot harm consumers.

Already the drugs are not permitted for use in New Zealand on any food-producing animal that is used in the production of produce destined for the European market (because EU bans directly apply to countries supplying that market). While their use may well be able to be justified on scientific grounds, it is increasingly difficult to maintain current use. A restriction on use is likely to lead to problems for ostrich breeders who claim that there are no alternatives and there are animal welfare difficulties if coccidiosis takes hold of the birds.

All of these issues are to be dealt with in the review. Once the consultation has been undertaken internally and with MAF and ERMA NZ, we will confer with all of the interested and affected parties on the issues and options.

 

Accidental intramuscular administration of long-acting veterinary medicines

The nature of long-acting injectable products is such that intramuscular administration is likely to result in a prolonged period of residue persistence compared to subcutaneous administration. The consideration of intramuscular administration data for long-acting injectable products with subcutaneous administration claims only is now a mandatory and enforced requirement for any residue package assessed by the ACVM Group for such products. However, this requirement has not been consistently applied to residue assessments in the past.

In consequence, the ACVM Group has adopted the following policy:

For any injectable long-acting product intended for subcutaneous administration only and for which intramuscular residue data has not been assessed by the ACVM Group and factored into the calculation of the withholding period the following label statements will be required.

"Ensure injection is subcutaneous.
Intramuscular injection will result in prolonged residues.
Where intramuscular injection may have occurred, animals producing meat and offal for human consumption must not be slaughtered within 91 days of the last treatment."

Unless registrants of currently registered products can demonstrate that the approved withholding period includes consideration of accidental intramuscular data, this statement will be enforced when products are updated or an application is made to alter an already updated label.

Should registrants wish to supply data and/or technical argument to demonstrate that the statements are not required for any particular product or to reduce the ‘default’ withholding period of 91 days for accidental intramuscular injection, they may be provided at the time of update. A separate application will not be required; however, the ACVM Group will charge the standard hourly rate ($108.00 plus GST) for the time taken to complete the assessment.