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AgVetLink December 2003 - Special Issue for Registrants

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Compliance process:
For products that are not currently registered but require registration under the ACVM Act by 1 July 2004

A number of trade name products were not subject to regulatory control under the previous legislation (Fertilisers Act, Stock Foods Act, Animal Remedies Act or the Pesticides Act) but are now covered under the ACVM Act. These products were covered by the transitional provisions of the ACVM Act (as long as they were legally existing prior to the start date of the Act on 2 July 2001) for a period of three years.

However, affected products must be either exempted from the requirement for registration (by Regulation) or registered by 2 July 2004 when the transitional provisions expire.

Affected products

The products now covered include things such as plant compound adjuvents (including wetting and sticking agents), pH buffers, drift retardants, and water conditioners.

Most of the products now included in the ACVM Act are approved by exemption via the ACVM Regulations 2001. Where products are covered by an exemption they are not required to be registered. For instance, there will be some products that will have ALL of the ingredients included on the appropriate Generally Recognised as Safe (GRAS) list. The trade name product is exempted and would NOT require registration. However, if one or more ingredients are not yet on the GRAS list and the product is used around or on food producing crops, an application for registration must be approved by 1 July 2004. After this date, the products will be illegal to manufacture, import, sell or use as they will be outside the transitional provisions of the ACVM Act.

The ACVM Group is using this opportunity to advise all current registrants who may be proprietors of affected products of their obligations.

Class determinations

If you wish to confirm the status of any product, the ACVM Group will undertake class determinations on receipt of an application. The ACVM Group will also be checking details of previous class determinations and contacting anyone who has affected products to advise them of the situation.

Compliance process

Where products are not exempted or registered after 2 July 2004, the ACVM Group will apply a similar compliance process as advised for products that are currently registered but are not updated to the ACVM Act (see page 4). A register of known products will be maintained on the ACVM website so that users can readily identify any products that would be illegal to use.

The ACVM Group will inform MAF Quarantine Services of the need for special vigilance for the types of products affected by the change and require that all imports of such products be held until approval for clearance from the ACVM Group has been issued. This will be done only once a product has been registered or exempted by Regulation – both processes that can take some considerable time.

Prohibition notices

In addition, prohibition notices will be issued to prohibit further manufacture, sale and use of the affected products. There may be a requirement for some proprietors to recall product from the market place. Affected companies may be placed on a pro-active compliance list. This means that an inspector appointed under the ACVM Act is likely to make unannounced visits to ensure that there are no breaches of the conditions of the prohibition notices issued, and that the company concerned is actively working towards getting the products registered.

 

Expiry dates on registrations

It is recognised that there will be less time available to update products to the ACVM Act with the expected influx of applications prior to 1 July 2004. With the introduction of a three year expiry date on registrations, the period will be shorter for products if an application is received close to the deadline. This is intended to provide an opportunity for a re-examination of updated products where limited time was available to complete the process and deal with any issues raised.

The proposed expiry dates on registrations will be:

• three years for applications received December 2003, January and February 2004
• two years for applications received March and April 2004
• one year for applications received in May and June 2004.

Where products have an application within the expiry period, the new expiry will be three years from approval of the application. For all other cases registrations will be re-examined prior to reissue of the registration.