Application for the Reassessment of a Hazardous Substance under ...

2.3.5 Details of ERMA New Zealand‘s qualitative risk assessment methodology are set outin Appendix H.2.4 Consideration of uncertainty2.4.1 Clause 8 of the Hazardous Substances and New Organisms (Methodology) Order1998 (the Methodology) states that the information used by the Authority whenconsidering an application must be relevant and appropriate to the scale andsignificance of the risks, costs and benefits associated with the substance.2.4.2 Clause 29 of the Methodology indicates that when the Authority encounters scientificand technical uncertainty relating to the potential adverse effects of a substance, theAuthority must determine the materiality and significance to the application of theuncertainty. Where any scientific or technical uncertainty is not resolved, theAuthority must take into account the need for caution in managing the adverseeffects of the substance (clause 30).2.4.3 Where the Authority considers that there is uncertainty in relation to costs, benefits,and risks (including, where applicable, the scope for managing those risks), theAuthority must attempt to establish the range of uncertainty and must take intoaccount the probability of the costs, benefits and risks being either more or less thanthe levels presented in evidence (clause 32).2.5 Ethical considerations2.5.1 In reviewing the information provided and identifying and assessing the adverse andpositive effects of dichlorvos, ethical matters relevant to the use of dichlorvos havebeen taken into account. Guidance is provided by the ERMA New Zealand EthicsFramework Protocol. 2 This framework acknowledges that individuals andcommunities hold a range of ethical views. It has been developed as a tool to assistall participants in the ERMA New Zealand decision-making process to:ask the ‗right‘ questions in order to identify areas where there are ethicalmatters to be considered; anduse the answers to these questions to explore whether and how ethicalconsiderations need to be addressed.2.5.2 The foundation of the framework is a set of ethical principles, supported byprocedural standards. The two general principles, which are embodied in the HSNOAct and the Methodology, are:respect for the environment; andrespect for people (including past, present and future generations).2.5.3 Under these general principles is a set of specific principles expressed as concerns.These are concern for animal welfare, autonomy, co-operation, culturalidentity/pluralism, human rights, human dignity, justice and equality, sustainabilityand wellbeing/non-harm.2.5.4 The primary mechanisms for supporting the principles outlined in the framework andfor evaluating whether or not they are upheld are the procedural standards of honestyand integrity, transparency and openness, a sound methodology, community andexpert consultation and a fair decision-making process.2.5.5 In preparing this application ERMA New Zealand has applied the criteria in theprocedural standards listed above to its evaluation and review of all the information2December 2005, ER-PR-05-1 12/05.Dichlorvos reassessment – application Page 20 of 436