Hobbs Marian: New Organisms and Other Matters Bill — First Reading 
Hobbs Marian: New Organisms and Other Matters Bill — First Reading 
[Volume:608;Page:5331] 
Hon MARIAN HOBBS (Minister for the Environment) 
: 
 I move  
That the New Organisms and Other Matters Bill be now read a first time. 
 At the appropriate time I intend to move that the bill be referred to the Education and Science Committee for consideration with an instruction to the committee to present its final report on or before 5 September 2003 and that the committee have the authority to meet at any time while the House is sitting except during questions for oral answer and during any evening on a day on which there has been a sitting of the House and on a Friday in a week in which there has been a sitting of the House despite Standing Order 193 and Standing Order 196(1)(b) and (c). 
I thank United Future and New Zealand First for their support for the first reading of this bill. In fact I live in hope of wider support for this bill and thus for the growing biotechnology industry in New Zealand. I also acknowledge the work done by officials and researchers in a number of ministries to meet the tight deadlines for a number of reports. This bill forms a key part of the Government’s response to the Royal Commission on Genetic Modification. Until 29 October this year a statutory restricted period a moratorium is in place whereby applications to release genetically modified (GM) organisms cannot be accepted by the Environmental Risk Management Authority. The restricted period has allowed time for important aspects of the Government response to the royal commission to be put in place. These have included amending the legislation which is what members have before them now to include a new form of release namely conditional release; reviewing the current liability regime for dealing with issues surrounding genetically modified organisms—this has also been done and is part of this bill—and establishing Toi te Taiao the Bioethics Council. I am pleased to say that this too has happened. It also includes developing a biotechnology strategy and this strategy has been released. 
Other aspects of the Government response include continuing and establishing programmes addressing areas of social economic ethical environmental and agricultural research as identified by the royal commission. Funding in this area has been increased. This research is specific to New Zealand’s priority needs but it will build on the wide body of knowledge internationally in this area. For example the Institute of Environmental Science and Research has been funded to carry out research into understanding horizontal gene transfer in order to predict any ecological consequences from genetically modified organisms in New Zealand. In addition Lincoln and Otago universities are investigating key socio-economic impacts of biotechnology and the underlying causal factors. 
Regarding the analysis of the economic impacts of releasing genetically modified organisms this completed economic research concludes that the most likely economic impact from the careful and considered release of GM organisms would be a small increase in gross domestic product over 10 years compared with a small decrease from forgoing releases of GM organisms. The research reinforces the Government’s strategic approach of proceeding cautiously with genetic modification while preserving opportunities. We have also considered exploring the potential for the coexistence of various forms of genetically modified conventional and organic agriculture. The Government has recently accepted that coexistence is possible between genetically modified and non-genetically modified agriculture based on a rigorous regulatory regime a case by case approach and consideration of the whole of the production chain. Work continues on the practical aspects of making coexistence work. Work is also under way on a range of issues related to intellectual property. This work which is under way at the moment forms part of the review of the Patents Act and the Plant Variety Rights Act. Lastly a discussion document on the development of a voluntary labelling system for GE-free products is now available for public comment. 
This bill includes significant changes to the way in which the Hazardous Substances and New Organisms Act operates and its relationship to other Acts. The bill has two main themes: firstly to provide a practical framework for proceeding with caution in the management of new organisms including GM organisms while preserving opportunities; and secondly to improve the overall effectiveness of the operation of the Hazardous Substances and New Organisms Act. To enable this to proceed with caution while preserving opportunities a new category for approval of new organisms which is called “conditional release” has been developed. A range of regulatory measures is provided in the bill to allow for this category of approval. This is supported by enforcement arrangements and an enhanced liability regime to ensure compliance. Some new organisms will be suitable for conditional release. 
In making its decision to approve a conditional release the Environmental Risk Management Authority must decide whether assuming conditions are operative a minimum standards test can be met. The minimum standards relate to significant effects of an organism on people and the environment. The authority will need to consider whether the organism could be recovered or eradicated if for example conditions were breached. The authority will be able to consider a range of conditions and select the most appropriate on a case by case basis. For example conditions might include monitoring the impact of an organism on the environment or allowing only sterile male pine trees or stipulating that certain management practices must be followed. To support conditional release and encourage compliance the bill contains provisions for an enhanced liability regime. These are a statutory strict civil liability rule and civil penalties regime for breaches of certain provisions relating to new organisms. The Ministry of Agriculture and Forestry has been designated as the agency responsible for all enforcement activity for new organisms. 
The second theme of this bill is to improve the overall efficiency of the Hazardous Substances and New Organisms Act. This is the result of both the royal commission’s recommendations and practical experience with the Act. To streamline processes in the Act and thus reduce compliance costs a fast-track process is proposed for low-risk organisms used in both human and animal medicines and for use in emergencies. In addition low-risk genetically modified organism imports will be approved on a similar basis as low-risk developments. What this means is that low-risk imports will be able to be assessed rapidly and decided on by the institutional biological safety committees under delegation from the Environmental Risk Management Authority. 
Other efficiencies relate to clarifying and updating processes. Provisions are made in the bill to allow the use of the appropriate taxonomic terms such as genus and for large-scale permutation of micro-organisms to be treated in the same way as any other application for developmental approval. There will also be more appropriate and realistic time lines for both reporting decisions by the Environmental Risk Management Authority and seeking compliance with a compliance order. Further because it is about new organisms zoo and circus animals will be brought further under the hazardous substances and new organisms regime. 
To improve knowledge of Treaty of Waitangi and tikanga Maori elements and decision making by the Environmental Risk Management Authority provision is made to formalise the role of the authority’s Maori advisory committee Nga Kaihautu Tikanga Taiao. Other provisions contained in this bill relate to anticipating future regulatory requirements by including them under the Hazardous Substances and New Organisms Act. These include certain developments using human cells and culture requiring approval for regeneration of new organisms and tissue and ensuring consistency in dealing with confidential information. Finally my backstop ability to call in applications to the Environmental Risk Management Authority will be extended to cover significant cultural spiritual or ethical effects. 
The provisions I have outlined represent complex and significant changes to the Hazardous Substances and New Organisms Act. There has been extensive public consultation both during the development of this bill and during the work of the Royal Commission on Genetic Modification. At select committee the public will again have an opportunity to help define the final shape of this legislation. In conclusion the changes proposed in this bill will ensure that the Hazardous Substances and New Organisms Act is pitched at the right level to allow genetic modification developments to proceed cautiously while preserving opportunities. 
It is almost 2 years since the Royal Commission on Genetic Modification reported to the Government. It advised the Government to proceed with caution. The procedures laid out in this bill will help us do just that. We wish to take advantage of a new technology but we wish to do that cautiously. This bill gives us the range of tools to do just that—to examine each new application for contained conditional or general release on a case by case basis. This bill also supplies the incentives for applicants to keep the conditions that may get set. The risk management approach taken in this bill complements and builds on that of the Hazardous Substances and New Organisms Act and is appropriate for the management of new organisms.