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Te Pou Oranga Kai O Aotearoa

 
 
 

NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/ 

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Transfer to ACVM registration

Change in plan to transfer individual trade name products to the ACVM Act by cancelling an animal remedy licence/pesticide registration and reissuing as an ACVM registration

As you are probably aware, under section 21(5) of the ACVM Act 1997, the ACVM Group cannot issue a registration for a trade name product containing a hazardous substance 'unless an approval for that substance has been issued under the Hazardous Substances and New Organisms Act 1996'.

Agreement with ERMA NZ
In September 2001, the ACVM Group sought agreement with ERMA NZ to show flexibility in the interpretation of an approval issued under the HSNO Act as referred to in section 21(5). It was recognised that the effect of taking a narrow interpretation of the word 'approval' was to require licensed animal remedies and registered pesticides to undergo a full HSNO approval process (or be transferred to the HSNO Act) before MAF could issue a registration for applications made under the ACVM Act. This was of particular importance to applicants who wished to make a B1 (identical product) application under the new legislation.

An agreement was reached whereby identical trade name products could be registered under the ACVM Act with reference to the existing registered or licensed product. The agreement was:

where the new product is the same as the referenced product (i.e. a dual label product with the same formulation, uses, manufacturer and registrant/ licensee as was previously covered by a single registration or licence), then the existing registration or licence (which is retained under the HSNO provisions) will be regarded as fulfilling the HSNO approval referred to in section 21(5) of the ACVM Act.

Essentially, the agreement was that the trade name product had to be identical to the original product registered under the Pesticides Act or licensed under the Animal Remedies Act and cause no change in risk profile, particularly for human health or environmental risks.

Use of mechanism
Following this agreement, the ACVM Group sought a further understanding with ERMA NZ to use this mechanism to register products under the ACVM Act that already existed as registered/ licensed products under the Pesticides Act 1979 or the Animal Remedies Act. Under the ACVM proposal, trade name products would be registered under the ACVM Act at the request of the registrant/licensee provided that they were identical in every way.

The ACVM Group believed that this mechanism was appropriate because conditions applied to current licences or registrations were considered sufficient to maintain adequate regulatory control, provided the product information and labels for each product were updated within a fixed period (before the end of the proposed ERMA NZ transition period). The products were identical in every way, so there would be no new risks associated with this mechanism.

After discussions with ERMA NZ, the ACVM Group was under the impression that agreement had been reached and details of the scheme were therefore outlined in the October 2001 AgVetLink (pathway three of the insert), and discussed at AGCARM and other public forums.

On 17 December 2001, however, the ACVM Group was informed that ERMA NZ could not support this proposal under the HSNO Act. For this reason, we are unable to register products by this route, and we regret any inconvenience caused.

Legislative development
However, the ACVM Group currently has a legislative development process in place that will permit us to transfer all agricultural compounds to the ACVM Act by means of a regulation made under section 88 of the Act.

The date for transfer of all of these trade name products to the ACVM Act is proposed as 1 July 2002 (see box below).

 

Update on transfer regulations

The making of regulations to transfer all animal remedy licences and pesticide registrations to ACVM registrations has been recommended to Cabinet. MAF is awaiting Cabinet's direction.

It is anticipated that if Cabinet approves the recommendation, the transfer will take effect as at 1 July 2002. At that stage all agricultural compounds will be regulated under the ACVM Act and animal remedy licences and pesticide registrations will no longer apply except where products are not covered by the ACVM Act.

 

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