Amendment to the AgResearch approvals - Controls (GMF98009)

 

GMF98009 Part I approval

Control 1.17

From the end of the current approval period on 18 November 2008 the genetically modified (GM) cattle and/or derived biological material may be held under this approval. However, no further breeding or production of any progeny may be initiated.

If the GM cattle and/or derived biological material fall within the organism description and the types of activities in new applications approved by the Authority, then the applicant may notify ERMA New Zealand that the GM cattle and/or derived biological material are required for the purpose of those approval(s). Upon notification from ERMA New Zealand, these approval(s) will then apply to those GM cattle and/or derived biological material.

If the new applications are declined by the Authority, destruction of the GM cattle and/or derived biological material, in accordance with Control 1.12, must begin one month after the notification of the decisions on the new applications and be completed within 12 months.

If there is a challenge to the decision on the applications, the cattle may continue to be held, provided no further breeding or production of any progeny is initiated, until all legal challenges are resolved. If, at the end of this period, the GM cattle and/or derived biological material are not covered by an approval, then destruction, in accordance with Control 1.12, must begin one month after the judicial decision is given, and be completed within 12 months.

Control 6.4

The applicant must provide a final report to ERMA New Zealand within 1 month of either the completion of the destruction of the genetically modified cattle and/or derived biological material or the date of receipt of the notification by ERMA New Zealand as per control 1.17. This shall include:

6.4.1 information on the items listed in section 4.13 of the MAF/ERMA Standard 154.03.067;

6.4.2 information on animal welfare issues including; behaviour traits of genetically modified cattle as against unmodified cattle in the field test, number and explanation of caesarean sections performed for genetically modified cattle; and issues associated with the induced lactation of genetically modified calves;

6.4.3 information on the stability of the genetic constructs used in genetically modified cattle; and

6.4.4 any reports provided to the local AgResearch AEC.

 

GMF98009 Part II approval

Control 1.20

Destruction of the genetically modified (GM) cattle and/or derived biological material must begin by the end of the approval period (23 May 2010). Their destruction must be completed within 12 months unless the GM cattle and/or derived biological material fall within the organism description and the types of activities in new applications approved by the Authority, and the applicant provides notification to ERMA New Zealand that the GM cattle and/or derived biological material are required for the purpose of those approval(s). Upon notification from ERMA New Zealand, these approval(s) will then apply to those GM cattle and/or derived biological material.