Second schedule of the Animal Remedies Act Regulations

One of the issues that has been highlighted recently is the need to review the second schedule of the Animal Remedies Act Regulations 1980. These regulations restrict the use of certain types of animal remedies at an active ingredient level (rather than a trade name product level as it is at present and will continue to be in the future under the ACVM Act). Part A deals with antibiotics and Part B deals with growth promotants.

The schedules relating to antibiotics are considerably out of date, both in terms of the products listed and especially as regards withholding periods for label claims. Because of the detail in the schedules and the fact that they are in regulation, there is a major job to be done in getting them up to date, and in keeping them that way during the course of the review of the products affected. If the schedule were to be reviewed rather than discontinued it would need to be managed at a trade name product level.

The development of the somatotropin policy (see article) also highlighted that if some somatotropin products were to be licensed, there would be the need to update the schedule by regulation. Following the EU Audit there is the need (again because of the prescriptive nature of the schedule) to review the limitations shown inside a time period that the regulation making process usually allows.

The ACVM Group has discussed the situation with regard to the regulations with MAF Legal and MAF Policy. It has been agreed that, even though the ACVM Act is expected to come in during the first quarter 2001, there is an urgent need to correct the anomalies.

The ACVM Group proposal is that the second schedule be removed altogether. As has been noted above, any revision of the second schedule would mean keeping details current at a trade name product level so the complexity of it would increase significantly. MAF Policy, with the support of the ACVM Group, is proposing that the schedule would be removed, as the level of detail (such as use level, direction of medication, claims, and limitations to be shown on the label) which appears at an active ingredient level, is better managed by placing conditions on trade name products. Some of these details would be available on the public register under the ACVM Act.

There are some penalties in the second schedule. MAF Legal has confirmed that there are equivalent penalties available for the breach of any conditions in the Animal Remedies Act proper, and that there are also penalty provisions and sanctions available for breaches in the Animal Products Act, the Dairy Industry Act and the Veterinarians Act.

The ACVM Group would welcome any comments on this proposal. Comments are requested to be put in writing, by 17 November 2000, to:

Mary Burnett
ACVM Group
PO Box 2526
WELLINGTON
Phone: 04 460 8750
Fax: 04 460 8771
Email: burnettm@maf.govt.nz