2. The reassessment process
Read an outline of why 1080 is being reassessed at this time and the steps that are required to be followed in the reassessment process.
2.1 Why 1080 is being reassessed
2.2 Steps in the reassessment process
2.3 Additional ERMA requirements for Maori consultation
The Hazardous Substances and New Organisms (HSNO) Act was passed in 1996. However, the part of the Act covering Hazardous Substances* did not come into effect until July 2001.
Hazardous substances that were already approved for use in New Zealand at that time are referred to as “existing substances”. Over the next 2 to 4 years there will be a transition period when these “existing substances” will be progressively transferred from the previous regulatory system (such as the Toxic Substances Regulations) to the HSNO framework.
“New substances” (that is, anything not imported or manufactured here prior to July 2001) require approval under the HSNO Act.
The Environmental Risk Management Authority (ERMA) was set up under the HSNO Act and has responsibility for approving applications for “new substances” and for transferring “existing substances”.
For the majority of existing substances, the transfer process will be fairly straightforward, with the substance being given a HSNO classification and assigned controls to manage the risks. These controls will generally be similar to those already in place. ERMA is currently in the process of transferring controlled vertebrate poisons, presently managed by MAF under the Pesticides Regulations, over to the HSNO system. This process includes pesticides containing 1080.
While ERMA has responsibility for managing the risks to public health and the environment from these pesticides, the risks to trade, animal welfare and agricultural security are managed by the Ministry of Agriculture and Forestry (MAF). So as part of the transfer process, 1080 will also be controlled under the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM).
However, the HSNO Act also allows for a much more rigorous re-evaluation of existing substances (a process referred to as “reassessment”), which is essentially the same process required for approval of any new substance. The first step in this process is for ERMA to decide if there are grounds for reassessment, when it must take into account whether there is:
- Significant new information about the effects of a substance;
- Alternative substances that may have become available which have similar or improved beneficial effects and have reduced adverse effects;
- Significant changes in how it is used or how much is used.
Reassessment provides a mechanism to re-examine the risks, costs and benefits of a hazardous substance as well as to review the controls that regulate the use of the substance. In effect, it is a review that starts from scratch.
In the current situation regarding 1080, the first step was for ERMA to decide if there were grounds for its reassessment. In 2001, the Animal Health Board and Department of Conservation decided to apply to ERMA for a reassessment of 1080 for the following reasons:
- Since its registration in 1964 there is new information on 1080 that should be formally assessed;
- Given the strong public interest and concern over 1080, particularly its aerial application, the reassessment process provides an opportunity for public discussion and scrutiny; and
- Both agencies are seeking increased use of 1080 to meet targets for reducing the levels of Tb in cattle and deer herds and in support of government strategies on sustaining biodiversity.
A decision in favour of reassessment was made by ERMA on 12 March 2002.
The following four steps are now under action by the applicants:
- Lifecycle assessment and hazard classification. This will identify the lifecycle of 1080, from its manufacture to its application and how it is disposed of. It will also identify the hazards 1080 poses to people and the environment throughout its life. Pesticides containing 1080, as well as the raw material itself, will be classified according to the new HSNO scheme.
- Consultation. For any substance that is used throughout the country and is of national interest, the HSNO Act requires the applicant(s) to undertake nationwide consultation. Given that 1080 meets both of these criteria, this requires a nationwide consultation to be carried out. In addition, it is necessary under the Act to assess any particular risks, costs and benefits that arise from the relationship of Maori and their culture and traditions with their taonga, as outlined in the next section. This discussion document is an important part of the national consultation process. You are invited to read it and respond to the matters it raises.
- Risk assessment. The consultations will be an important source of information to supplement the comprehensive assessment of the risks, costs and benefits of 1080, which will then be compiled by the applicants. The applicants will also be providing information on how 1080 will be managed, including the management of any adverse effects and the risks associated with its use.
- Overall evaluation and submission. Finally, the applicants will prepare an overall evaluation by pulling together all the information that has been gathered on risks, costs and benefits. This will form the basis of the application to be submitted to ERMA.
Once ERMA receives the application, a new phase of the process begins under a timetable and process that will be set by ERMA. This will include an invitation for written submissions and the holding of a hearing. The decision-making process of ERMA involves weighing up all the scientific and non-scientific information in the application, including information in the public submissions. ERMA will then make a judgement on whether 1080 should continue to be approved for use in New Zealand and if so, what controls or conditions should apply to that use.
In the meantime, the use of 1080 will continue to be controlled by the statutes, regulations and operating procedures already in place. The transfer process is proceeding in parallel with the reassessment but is a completely separate exercise. Where there are requirements under the Resource Management Act to obtain resource consents for 1080 control operations, these requirements will also continue.
The Environment Risk Management Authority (ERMA) has protocols and guidelines for applicants which outline how ERMA takes into account the principles of the Treaty of Waitangi and the relationship of Maori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga (valued resources, prized possessions) (ERMA 1999). The Authority has a duty to make informed decisions on applications in relation to Maori interests. Accordingly, in relation to this reassessment of 1080, it requires that the applicants conduct nationwide consultation with Maori. The ERMA protocol states that it will generally be sufficient for nationwide consultation to be at iwi rather than hapu level.
In the course of these consultations the applicants will need to find out the views of Maori on how 1080 may impact on their taonga and other concerns they may have. The ERMA protocol outlines matters which are likely to be of potential significance to Maori and which may require consultation. While iwi and hapu will decide which matters are of significance to them, the following list of topics extracted from Annex 1 of the ERMA protocol indicates some of the potential matters for comment. Maori may wish to raise other matters in addition to the following.
- Potential issues of significance in relation to Treaty outcomes;
- Potential issues of significance in relation to environmental outcomes:
- the continued and improved availability, quantity and quality of traditional food resources (mahinga kai)
- the continued availability, quantity and quality of traditional Maori natural resources
- the retention of New Zealand’s diverse range of indigenous flora and fauna
- the protection of indigenous flora and fauna valued by Maori
- the purity of water and the need to retain and extend its productive and life-sustaining capacity
- the purity of the land and the need to retain and extend its productive and life-sustaining capacity
- the purity of human health and well-being
- the restoration and retention of natural habitats;
- Potential issues of significance in relation to cultural outcomes:
- the recognition and protection of Maori cultural, spiritual, ethical or socio-economic values
- the protection of the mauri of peoples
- the preservation and maintenance of traditional Maori knowledge by Maori
- the maintenance, expression and control by Maori of their traditional practices, e.g. kaitiakitanga, tapu and rahui
- the protection of the mauri of valued flora and fauna
- the protection of the mauri of land and waterways; and
- Potential issues of significance in relation to health and well-being outcomes:
- the protection of taha wairua: spirituality, balance with nature, protection of mauri
- the protection of taha whananunga: responsibility to the collective, the capacity to belong, to care and to share
- the protection of taha hinengaro: mental health and well-being, the capacity to communicate, to think and to feel
- the protection of taha tinana: physical growth and development.
From their consultations with Maori, the applicants will prepare an assessment of the risks, costs and benefits of 1080 that are significant to Maori. This assessment will then form part of the total application that will be duly submitted to ERMA for its consideration.
ERMA may treat as confidential any information that has been classified as being culturally sensitive by those Maori who have provided such information.
The HSNO Act defines a hazardous substance with one or more of the following intrinsic hazardous properties: explosiveness, flammability, oxidising capacity, corrosiveness, toxicity and ecotoxicity. The Act defines “ecotoxic” as capable of causing ill health, injury or death to any living organism.
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