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Where necessary, other specific prohibitions on certain uses that further limit any discretionary use of the product will be applied. Other conditions may also be imposed. For example, if the antibiotic is used in an intramammary preparation, milk may not be allowed to be fed to calves until after the specified withholding period (plus four days if used in dry cow therapy product). The issue of the effect intramammary use may have on the development of resistance in human pathogens remains unresolved. It may be that use will be restricted even further in the future.

Where it is considered essential to control the overall use of an antibiotic even for therapeutic purposes, the Board will impose even more stringent controls. This level of control would be applied to products containing antibiotics (e.g. virginiamycin) that in human medicines are subject to more stringent controls than the basic prescription condition, i.e. restricted to hospital specialists etc. (group 3). The products would still be classified as PAR class 1 products with conditions similar to those imposed on group 2 but the following obligations will also be imposed:

• all discretionary use for any purpose other than that specified on the label would be prohibited;

and

• the prescribing veterinarian would have to notify MAF of every case in which the antibiotic is prescribed, giving the date, species prescribed for and disease treated.

Some antibiotics (group 4) will be prohibited from use in food-producing animals and some may even be prohibited from use as a veterinary medicine.

All antibiotic products have now been reviewed and licensees contacted. Changes must be made to product labels by July 2002.

Codex Committee on Residues of Veterinary Drugs in Foods

The 13 th meeting of the CCRVDF was held in Charleston, South Carolina, from 4 - 7 December 2001. New Zealand was represented by Dr Bill Jolly (Leader)* and John Reeve.

There have been problems in the past with proposed MRLs being held up in the process on political grounds, and this has resulted in pressure to review all the CCRVDF procedures. For example, two of the grounds for objecting to progressing MRLs were that the objecting country had not considered that veterinary drug for registration and so had no knowledge that the suggested residues were acceptable, or that the suggested MRLs did not match the objecting country’s domestic MRLs – that is, there was no scientific basis required for objecting.

However, because of the lack of scientific reasoning behind the objections, New Zealand, the USA and Australia encouraged the 12 thmeeting of the CCRVDF to accept a requirement that any country objecting to an MRL being progressed had to forward supporting data to the Joint Expert Committee on Food Additives (JECFA). This had to be done in a timely manner so that the JECFA expert opinion on the objection could be considered by the next CCRVDF. Failure to get data supporting the objection to JECFA within the timeframe meant that the MRL must be progressed to the next appropriate step in the Codex system.

As a result, many MRLs progressed at the 13th meeting. Because this requirement is now an accepted precedent, it is hoped that future progressing of Codex MRLs will continue at a more acceptable rate.

The report of the meeting is being prepared and a debriefing meeting will be held for all those interested when the report is available.

* Dr Bill Jolly has now taken up the position of Veterinary Counsellor in Brussels following his move from Washington last year.

Registration and Product Datasheet

Some minor changes have been made to the Registration and Product Datasheet form, based on how the forms have been filled in and comments received so far from applicants. The changes include:

• whether the product is low risk;
• request to list both current and proposed formulations for Type C1 applications;
• additional explanatory notes to clarify some of the questions.