- Print Friendly - Help

AgVetLink August 2004: Page 3

Previous page  | Contents |  Next page

---

LEGISLATION

Amendment to the ACVM Regulations 2001

The ACVM Group is proposing an amendment to the ACVM Regulations 2001. Because of the technical nature of these Regulations, amendments are needed regularly to:

• add or delete (amend the definition or conditions of) groups of agricultural compound products that are exempt from registration;

• add or delete items from the list of plants prohibited from use in exempted herbal veterinary medicines;

• add or delete substances prohibited from use as agricultural compounds;
  or

• add or delete items from the lists of generally recognised as safe (GRAS) substances.

Proposed changes

Highlights of the proposed changes in the Regulations are:

Removal of the obligation to notify trade name products in Schedule 3 of the Regulations

It is proposed to remove the obligation in Regulation 7 to notify and provide annual reports for products that fit the definition of agricultural compounds listed in Schedule 3. A new obligation will be imposed to provide information about particular products before they are first offered for sale in New Zealand. At this stage, the new obligation will apply only to three entries in Schedule 3:

• topical skin preparations;

• anti-diarrhoea preparations; and 

• respiratory tract modifiers.

Imposition of an obligation to avoid violative residues

It is intended to place an obligation on the proprietor of agricultural compound products used to manage plants that are exempt from registration to formulate, manufacture and label the products in a way that avoids any residues in violation of applicable food residue standards. This is consistent with conditions imposed in other parts of the Regulations and is more practical than requiring all the ingredients to be listed as generally regarded as safe (GRAS).

Removal of exemption for fertilisers and fertiliser additives that are raw or composted biological wastes

The ACVM Group considers wastes products that are not subject to adequate processing to manage the risks are still just wastes, no matter what claims are made about them. The Group considers that the application of wastes to land should be regulated under the Resource Management Act 1991 and should not be given the status of agricultural compound.

Removal of the unqualified exemption from registration for plant material

The removal of the exemption from registration for plant material will have two consequences. Firstly, herbal preparations containing naturally occurring active ingredients (pyrethrums, azidirectin etc.) will have to be registered. Secondly, feed commodities (hay, silage, grain etc. sold as animal feeds) will be subject to Regulation 8, exempting them from registration but obliging them to comply with the minimum standards in Schedule 4.

New exemptions

Exemptions are being proposed for:

• homeopathic preparations for the management of plants;

• plant tissue culture products;

• plant graft protection products; and 

• animal semen extenders and ova media.

Discussion of proposals

The NZFSA Policy section is preparing a discussion document on the proposed amendments. It is expected that the document will be available (and posted on the ACVM Group website) during August. Readers who may be interested in the amendments and in making submissions on the proposal should check the website.

 

 

Amendment to ACVM Act

Seventeen submissions on the proposed amendment to the ACVM Act were received during the public consultation phase. Several submissions expressed concern about the public health/HSNO interface; comments were generally useful and constructive.

Analysis of the submissions has now been completed and will soon be published on the website. Issues raised will be worked through before the next step in the process, which is presenting the proposal to Cabinet for Select Committee consideration.

 

 

PDS not a ‘pick + mix’

We wish to advise applicants that ALL sections of the Product Data Sheet (PDS) form the ‘registration’ of the product once it is approved.

It is not an option to complete some parts and remove others. The PDS should not be tampered with in any way.