Annex 1 ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION ON GROUNDS FOR REASSESSMENT OF A NEW ORGANISM IN CONTAINMENT Application Code REA99002 Considered by Genetic Modified Organisms (GMO) Standing Committee acting under the delegation of the Environmental Risk Management Authority. Date 4 August 1999 Request Details Applicant Bas Walker, Chief Executive, ERMA New Zealand Category Grounds for reassessment of a substance or contained organism [section 62(1)(b) of the Hazardous Substances and New Organisms Act 1996] Date Application Received 20 April 1999 Description The request invited the Committee to decide whether there are grounds for reassessing three field tests of genetically modified canola, and is made under section 62 of the Hazardous Substances and New Organisms Act 1996 (HSNO Act). The controls for these field tests were set on the recommendation of the Interim Assessment Group (IAG) and transferred to the HSNO Act when the Act commenced for new organisms. The proposed grounds for reassessment are that the post-harvest monitoring arrangements and periods specified in the current controls may not be sufficient to ensure that there is no germination of canola seed remaining in the soil at the field trial site, given that canola seed has been shown to remain viable in soil for periods of up to 10 years. The current controls require isolation zones of 2km for No.s 42 and 43 and 400m for No. 60 to be monitored during the trial and for a subsequent four years, or one year beyond the time when no new seedlings appear. Decision The Genetically Modified Organisms (GMO) Standing Committee agreed that Grounds Exist to Reassess the following three field tests of genetically modified canola, originally approved by the Minister for the Environment on the recommendation of the Interim Assessment Group (IAG), and deemed approved under the Hazardous Substances and New Organisms Act 1996 as Trial Numbers 42, 43 and 60 in the New Zealand Gazette Issue No. 101. Annex 1 Trial Number Applicant: Trial Management Company: Organism(s): Location(s): Approval period: Trial Number Applicant: Trial Management Company: Organism(s): Location(s): Approval period: Trial Number Applicant: Trial Management Company: Organism(s) Location(s): Approval period: 42. Zeneca Seeds. Inc. Canada Cropmark New Zealand Ltd. Ashburton Brassica napus and Brassica rapa resistant to Monsanto Corporation’s Roundup ReadyTM gene for glyphosate herbicide. Pukeuri, North Otago November 1996 to November 1997, with monitoring to be maintained for subsequent 4 years (to July 2001) or one year beyond the time when no new seedlings were found. 43. Crop and Food Research Limited on behalf of Plant Genetic Systems, Belgium. Enzol Holdings, Ashburton Brassica napus subsp. oleifera and Brassica rapa modified by (a) Barnase gene and Bastar gene for male sterility and restoration, (b) neomycin phosphotransferase gene (NPT II) for kanamycin resistance, and (c) phosphinothricin gene (PAT) from Streptomyces virichromogenes for resistance to glyphosinate herbicides. 1. Dromore, Canterbury 2. St Andrews, South Canterbury November 1996 to November 1997, with monitoring to be maintained for the subsequent 4 years (to April 2001) or one year beyond the time when no new seedlings were found. 60. Mr Neil Rampton on behalf of Zeneca Seeds. Inc. Canada Cropmark New Zealand Ltd. Ashburton Brassica napus and Brassica rapa modified by Monsanto Corporation’s Roundup ReadyTM genes for tolerance to glyphosate herbicide. Hendley Block, Shands Road, Lincoln November 1997 to November 1998, with monitoring to be maintained for the subsequent 4 years (to May 2002) or one year beyond the time when no new seedlings were found Relevant Legislative Criteria Section 62 of the HSNO Act sets out grounds that may be considered by the Authority in deciding whether a reassessment is justified. By implication the use of the phrase ‘take into account’ other grounds may be considered as well. Reasons for the Decision Although the circumstances of each trial differ with respect to geography, nature of the modification, and the monitoring regime, a common factor is that canola seed, remaining in the soil after the trials may remain viable for long periods. Periods of up to 10 years are quoted in Annex 1 the literature. The monitoring periods stated in the current controls are significantly less than this. It is concluded that there is sufficient uncertainty as to whether the current monitoring regimes are adequate to ensure that no genetically modified canola seed will germinate in or around the trial site, for grounds for reassessment to exist.