1. Introduction

This section provides a brief outline of the HSNO Act, the Royal Commission on Genetic Modification and the Government’s response to the Royal Commission, the areas covered, and how this discussion paper relates to the eventual amendment of the HSNO Act through the HSNO (New Organisms) Amendment Bill.

1.1 Hazardous Substances and New Organisms (HSNO) Act

The HSNO Act is a recent environmental and health and safety law, with two main parts. The part covering new organisms came into force on 29 July 1998 and that for hazardous substances on 2 July 2001.

The term ‘new organism’ refers to any organism not legally present in New Zealand before 29 July 1998. New organisms can include any new species of any animal, plant, fungus, bacterium or virus. The term also includes genetically modified organisms (GMOs). Broadly speaking, ‘hazardous substance’ includes any substance that can damage the environment or adversely affect human health and safety (other than substances that are solely radioactive, ozone-depleting or infectious).

Anyone wanting to introduce (import, develop, field test or release) a new organism or a hazardous substance must apply to the Environmental Risk Management Authority (ERMA) to do so. The Act establishes a consistent process for assessing the risks posed by hazardous substances and new organisms, and for setting national controls to manage their environmental effects and risks.

All users of new organisms and hazardous substances must comply with the controls imposed by ERMA on approvals for new organisms and hazardous substances.

The primary focus of the amendments discussed in this paper is on GMOs. However, in many instances the proposed amendments will also relate to new organisms in general, and in some cases to hazardous substances.

To find out more about the HSNO Act, please refer to Your Guide to the Hazardous Substances and New Organisms Act June 2001, or visit the Ministry for the Environment’s HSNO website at www.hsno.govt.nz. To find out more about ERMA and how it handles applications to introduce new organisms or hazardous substances, please visit the ERMA New Zealand website at www.ermanz.govt.nz.

1.2 Royal Commission on Genetic Modification

The Royal Commission on Genetic Modification was an independent body established by the Government in May 2000 to look into and report on the issues surrounding genetic modification in New Zealand. The Royal Commission reported to the Governor-General on 27 July 2001. More information on the Royal Commission is given in Appendix 1 and also at www.gmcommission.govt.nz.

A primary objective of the Royal Commission was to identify any changes considered desirable to the current legislative, regulatory, policy or institutional arrangements for addressing, in New Zealand, genetic modification, GMOs and their products. While satisfied that the basic regulatory framework for controlling genetic modification in New Zealand is appropriate and that the key institutions carry out their functions conscientiously and soundly, the Royal Commission recommended a number of improvements.

1.3 The Government’s response to the Royal Commission

The Government released its initial response to the Royal Commission’s report on 30 October 2001. The Government supports the overall strategy of preserving opportunities suggested by the Royal Commission. However, it has come to some different conclusions about how the overall strategy of preserving opportunities should best be implemented. The differences are in two main areas:

• the extent to which commercial release should be possible in the immediate future
• the conditions under which research should be able to proceed.

The Government decided that there is a need to restrict the release of GMOs (with limited exceptions) for a period while work, analysis and research identified as necessary by the Royal Commission is carried out. It has therefore passed the HSNO (Genetically Modified Organisms) Amendment Act 2002. This Act puts in place a legislated two-year restricted period during which time no applications can be lodged with ERMA for release of GMOs except those that provide direct benefits to human or animal health, or are in accordance with the existing emergency provisions of the HSNO Act.

The restricted period is to allow time to:

• put in place amendments to the HSNO Act, many of which are outlined in this document
• establish a Bioethics Council
• complete generic work on the economic impacts of any GM crop release on the strategy of ‘preserving opportunities’
• establish or continue research programmes addressing areas of socioeconomic, ethical, environmental and agricultural research which were identified by the Royal Commission as needing additional work
• undertake appropriate work on other issues identified by the Commission.

To find out more about the overall response of the Government, please visit Risks from new organisms. The information on this website includes the Cabinet papers advising on the Royal Commission on Genetic Modification, and a summary of the decisions the Government made on the individual recommendations presented in the report of the Royal Commission.

1.4 The aim of this discussion paper

This discussion paper examines proposals and options for amendments to the HSNO Act. Consequential or related amendments to other acts such as the Agricultural Chemicals and Veterinary Medicines (ACVM) Act 1997 and Medicines Act 1981 may also be required in specific cases.

The paper also discusses issues around liability for the possible adverse effects from GMOs. Several options, including the status quo, are identified. This section does not presuppose legislative change in this area.

The paper describes the intended approach to amend the HSNO Act and provides a basis for developing an amendment Bill. It is not a set of draft amendments, or a complete description of all amendments that may be proposed under this Bill. Rather, it represents work in progress and as such is more comprehensive in some sections than others. In some cases several options for amendment are merely outlined; in others more detailed proposals are discussed. The idea is to provide a basis for all those interested to comment on the proposals.

The next step in this process will be to analyse submissions, provide a summary to submitters and draw on these to develop final proposals for Government consideration. Once the Government has decided on the policy for amendments, the HSNO (New Organisms) Amendment Bill to enact the amendments will be drafted by parliamentary counsel. The Bill will then go to select committee, and interested parties will have an additional opportunity to comment on the proposals at that stage.

1.5 The main areas covered

1.5.1 Recommendations of the Royal Commission

The proposals for amendment in this paper address those recommendations of the Royal Commission relating to:

• simplifying approval processes for laboratory-based research that involves genetic modification
• gaps in HSNO Act coverage
• a new category of approval called ‘conditional release’
• streamlining the approval process for medicines that are or contain GMOs
• confidential information supplied with applications for approval
• grounds for ministerial call-in of applications.

Further details of the relevant Royal Commission’s recommendations and the Government’s decisions on the recommendations are given in Appendix 2.

The Royal Commission also recommended that section 8 of the HSNO Act be amended to provide that effect be given to the principles of the Treaty of Waitangi (Recommendation 11.1). The Government has agreed that the HSNO Act should be amended so that it more appropriately reflects the Treaty of Waitangi relationship. It invited a group of Ministers comprising the Minister for the Environment, the Minister of Māori Affairs and the Associate Minister of Māori Affairs, the Minister of Research, Science and Technology and the Minister in charge of Treaty of Waitangi Negotiations to appoint a Māori Reference Group to assist in addressing this issue.

The Government is appointing a Māori Reference Group to provide input on how the HSNO Act could more appropriately reflect the Treaty of Waitangi relationship. These amendments are not discussed in this paper.

1.5.2 Zoo and circus animals

Under the current transitional arrangements in the HSNO Act, animals in existing registered zoos and circuses are deemed to be new organisms and the registrations are deemed to be approvals under the HSNO Act to import those organisms into containment. However, a number of issues have been identified as necessary to complete the transition of these animals to the HSNO regime. This paper also seeks comment on the amendments to the Act that are required.

1.5.3 Other issues

The HSNO Act is a major piece of legislation. A number of issues have arisen in light of experience with the operation of the Act, some of which have general application to all new organisms and hazardous substances. These issues are also discussed, and options and proposals for amendments are given.