ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION ON GROUNDS FOR REASSESSMENT OF A NEW ORGANISM IN CONTAINMENT Code REA99001 Considered by Genetic Modified Organisms (GMO) Standing Committee acting under the delegation of the Environmental Risk Management Authority. Date 4 August 1999 Request Details Prime Contact: Category Date Application Received Bas Walker, Chief Executive, ERMA New Zealand Grounds for reassessment of a substance or organism (section 62(1)(b) 23 April 1999 Description The request invites the Committee to decide whether there are grounds for reassessing New Zealand King Salmon Limited’s genetically modified salmon development in containment, and is made under section 62 of the Hazardous Substances and New Organisms Act 1996 (HSNO Act). This work is being carried out under the terms of controls which were originally set on the advice of the ACNGT, and transferred to the HSNO Act when the Act commenced for new organisms. The proposed grounds for reassessment are that the controls attached to the transferred approval may not be in full accordance with the requirements of the Third Schedule, Part 1: Matters to be addressed by Containment Controls for Development and Field Testing of Genetically Modified Organisms of the HSNO Act. The request also asks the Authority to determine whether any subsequent reassessment should be treated as a non-notified development, a notified development or a field test (notified) application. Decision The Genetically Modified Organisms Standing Committee has decided that there are Grounds for Reassessing genetically modified salmon in containment at New Zealand King Salmon Limited’s Kaituna Hatchery, Blenheim, Approval number 156, New Zealand Gazette Issue No. 101. Any reassessment resulting from this is likely to be considered for as a non-notified development. Relevant Legislative Criteria Section 62 of the Hazardous Substances and New Organisms Act 1996 sets out grounds that may be considered by the Authority in deciding whether a reassessment is justified. By implication (the use of the phrase ‘taking into account’) other grounds may be considered as well. Reasons for the Decision The following items in the Third Schedule Part 1 of the HSNO Act are especially relevant: 1(a) 1(e) Requirements for treatment and decontamination to prevent escape by way of expelled air, discharge of water or liquid wastes, removal of solid waste or goods, or breaches in the facility, and Requirements for the disposal of any biological material. Grounds for reassessment exist because of uncertainty over whether the current controls adequately assure containment of the genetically modified fish and gametes. In particular, it is not clear whether the existing controls are sufficient to ensure that viable fish, eggs or sperm cannot escape from the trial site, and whether the ability of the present controls to allow disposal of the fish by offsite burial poses unacceptable environmental risks. Should a reassessment be subsequently applied for, it is the Committee’s view that it should be processed as a development application. The reason for this is that a fish grow-out facility is similar in concept and effects to a greenhouse, used to grow genetically modified plants, following development in a containment laboratory. The greenhouse is a direct extension of the laboratory as is the grow-out facility. The type of fish grow-out facility involved also does not have the characteristics of a field test environment, ie it is constructed purely for the purposes of growing the fish, is as contained as is feasible for that purpose and is not explicitly similar to the environment in which the salmon would be released (a river or the sea). The GMO Standing Committee has delegated authority to decide whether development applications require public notification. The test in the Act is that of whether there is likely to be significant public interest. The default position is not to notify. The Committee’s view is that while there may be public interest in the trial as a whole, the focus for a reassessment would be on technical matters relating to the adequacy of containment. Given this focus, the Committee considers that public notification is not justified. Signed on behalf of the Authority _____________________ Chair _____________________ Name Page 2 of 2 __________________ Date