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AgVetLink: Number 59, December 2006

ACVM and ERMA Workshops

The ACVM Group, in conjunction with ERMA New Zealand, held registrant/consultant workshops in November in Wellington and Auckland.

In general, these were well received and the agenda items created some interesting dialogue. A number of the questions asked at the workshops are presented below. Some of our responses will require further in-depth discussion with all staff and other interested parties before complete answers can be provided.

1. Would the Group consider a special relabelling category for manufacturing that does not attract irrelevant manufacturing specifications?

This is likely to be revisited in the review of our information requirements, which is scheduled for early 2007.

2. Would Warren Hughes check with the US EPA on his upcoming visit about its view on release and expiry specifications?

Warren is overseas at present and will report on this in the next issue.

3. Would the Group consider how it updates and integrates new international standards and requirements to stay in line with the international community?

The Group regularly monitors changes in international standards and requirements. Changes are reviewed to see if they are relevant under New Zealand conditions or impose trade obligations that must be complied with. ACVM standards and requirements are modified at their next review unless immediate action must be taken. Affected parties are advised, but consultation may not occur because the change is obligatory. If options are possible, consultation will be carried out as part of the revision of standards.

4. Would the Group consider how it could address the nonylphenol issue to make it more transparent and minimise disruption if change is necessary?

Nonylphenol is under review with ERMA. As far as the ACVM Group is concerned, if required, we would follow our reassessment process and this would be in sufficient time for companies to supply us appropriate information.

5. Would the Group consider a ‘slice of life’ review in regard to counterfeit and/or ‘out of spec’ products (e.g. products with higher impurities or lesser concentration of actives than they should have)?

We will consider adding this as we set up and decide on the programme for 2007.

6. Would the Group give some more thought to the cost implications re data assessors?

In the first instance, the ACVM Group will have training sessions to bring data assessors up to speed. The timeframe will be announced in the next AgVetLink.

7. Would the Group consider taking up a role of providing good operational practice guidance in regards to pest control products (fly sprays etc.)?

The rules around these types of products may change under the new definition of an agricultural compound in the ACVM Act Amendment. This will be included in the consultation on ACVM Act changes.

8. Would the Group make up a list of excipient trade name products (surfactants etc.) for which it already holds formulation information, so applicants would know that if they included them in their product they would not have to get the same information from the proprietors of those products?

The ACVM Group will look at what we can do to assist, but essentially the excipients are not associated with any products. We do have information but excipients change and this makes it quite difficult.

9. Is it always necessary to get agreement from a registrant to source information about an active ingredient from the AI manufacturer/proprietor? Sometimes requesting that information is, in itself, commercially sensitive.

This will be actioned in the new year and the question will be presented to the Operational Policy Committee.

10. Would the Group take into consideration the significance of a deviation from the expiry specifications before deciding what regulatory action should be taken in a non-compliance case?

The risks associated with the non-compliance would be the deciding factor.

11. Provisional registration: Can a formulation be changed but keep the same trade name?

The provisional registration requirements will be reviewed as we go about reviewing the overall registration requirements early next year. In regards to this question, we will look at the rules governing when a change in formulation triggers a new registration and discuss the issue with the Commerce Commission.

12. Provisional registration: Importation of trade name products for use in labs. ERMA’s stance is that they do not give an approval for something that is being imported for lab use.

We acknowledge the issues and, again, this will be addressed in reviewing provisional registrations with a view to aligning with ERMA as far as possible.

13. Would the Group amend or review the list of silicants in the chemistry standard?

This is being actioned.