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AgVetLink March 2004 - Special Issue for Veterinarians: Page 8

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Zealand husbandry practices, the expected rate of MRL breaches is exceedingly low when label directions are followed.

It is important to note that residue trials are conducted under controlled circumstances. Animals are healthy and monitored throughout. Treatment is applied regularly and precisely and, for lactating cows, milking is regular and complete.

Veterinarians should consider the individual circumstances each and every time any veterinary medicine with a WHP is prescribed for use in food-producing animals and, where considered prudent, recommendations made that WHPs should be increased. Remember that the WHP will usually be set at time of registration to achieve the shortest possible treatment to harvest interval.

Milk withholding periods are expressed as both a number of hours and number of milkings. Milk can go back into the vat once either of these is met, right?

FICTION

Trial data submitted for assessment is gathered under controlled circumstances, which includes twice daily milking to complete evacuation usually at 12 hourly intervals. The milk WHP approved is therefore a function not only of the time that has elapsed, but also the number of milkings that have occurred in the time taken for residues in the milk to comply with the relevant MRL.

Current farm practices are changing and herd management may not revolve around milking twice daily at 12 hourly intervals. Veterinarians must be aware that, where this is not the case, the approved WHP may need adjustment – see box below.

As a general rule, the number of full milkings is the most critical factor for veterinary medicines administered via the intramammaryroute (because the primary route of residue depletion is via the milk). On the other hand, in general, the number of hours is the critical factor for veterinary medicines administered orally or parenterally (because the milk acts as only one of the routes of residue excretion).

All veterinary medicine label claims have been approved by the regulator, haven’t they?

Although that statement was true under the Animal Remedies (AR) Act 1967, it is no longer necessarily true under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997.

Under the AR Act, the Animal Remedies Board was simply required to ‘ensure that animal remedies are efficient and safe for use on animals’. In essence that meant that if a product met the definition of an animal remedy all label information had to be approved by the regulators regardless of the nature of the claim.

As discussed in the Q & A forum on the current regulatory system for veterinary medicines (see pages 2-3), regulators are now required by the ACVM Act to manage specified risks associated with the use of agricultural compounds. In essence, that means if any aspect of the product does not trip the thresholds established for each risk, then the ACVM Group does not have the authority to require, assess or approve any data or label claims relating to that aspect.

In addition, Select Committee, when considering the ACVM Act in its early stages made comment that there was no need for the ACVM Act to consider consumer protection for its own sake as this was already adequately covered by other legislation.

What all of this means is that if veterinary medicine label efficacy claims are such that animal welfare will not suffer as a result of inefficacy, such claims can appear on those labels without the approval of the ACVM Group. This is true for most fertility and productivity enhancement claims. In addition, promotional slogans like ‘the best on the market’ can be made without the approval of the ACVM Group.

Where claims and advertising that are not regulated by the ACVM Group are found to be untrue, fair trading legislation comes into play. The Commerce Commission enforces this legislation. Although the ACVM Group no longer directly attempts to resolve issues that relate only to breaches of consumer legislation, any complaints received by the Group will be forwarded to the Commerce Commission for assessment.

The ACVM Group continues to require the establishment of efficacy for all veterinary medicines where label claims are such that animal welfare will suffer as a result of inefficacy, as well as the establishment of target animal safety for all veterinary medicines.