New Organisms and Other Matters Bill 2003, first reading

Mr Speaker, I move that the New Organisms and Other Matters Bill 2003 be now read a first time. At the appropriate time I intend to move that the Bill be referred to the Education and Science Select 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 Orders 193 and 196(1)(b) and (c).

Mr Speaker I want to thank United Future/NZ First for their support for this first reading of this Bill. In fact I live in hope of wider support for this bill and thus for biotechnology in New Zealand.
Mr Speaker, this Bill forms a key part of the government response to the Royal Commission on Genetic Modification. Until the 29th of October a statutory restricted period (moratorium) is in place where applications to release genetically modified 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 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 been done, and is part of this Bill.
·Establishing Toi te Taiao: the Bioethics Council. I am pleased to say this has happened.
·Developing a biotechnology strategy. This Strategy should be released shortly.
·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 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, ESR 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.
·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 GMOs would be a small increase in GDP over 10 years, compared to a small decrease from forgoing GMO releases. The research reinforces the government’s strategic approach of proceeding cautiously with genetic modification while preserving opportunities.
·Exploring the potential for the co-existence of various forms of GM, conventional and organic agriculture. The government has recently accepted that coexistence is possible between GM and non-GM 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 on a range of issues related to intellectual property. This work, which is underway at the moment, forms part of the review of the Patents, and Plant Variety Rights Acts.
·And lastly, a discussion document on development of a voluntary ‘GM-free’ labelling system is now available for public comment.

Mr Speaker, this Bill includes significant changes to the way the Hazardous Substances and New Organisms (or HSNO) Act 1996 operates and its relation to other Acts. The Bill has two main themes:
·to provide a practical framework for proceeding with caution in the management of new organisms (including GMOs) while preserving opportunities; and
·to improve the overall effectiveness of the operation of the HSNO Act.

To enable us to proceed with caution while preserving opportunities, a new category of approval for new organisms has been developed called ‘conditional release’. 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 if, 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. ERMA will need to consider whether or not the organism could be recovered or eradicated if, for example, conditions were breached. ERMA 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 for Agriculture and Forestry has been designated as the agency responsible for all enforcement activity for new organisms.

The second theme of this Bill, Mr Speaker, is to improve the overall efficiency of the HSNO Act. This is the result of both the Royal Commission’s recommendations and practical experience with the HSNO 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 GMO 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 Institutional Biological Safety Committees under delegation from ERMA.

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 fermentation 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 timelines for both reporting decisions by ERMA and seeking compliance with a compliance order. And, finally, zoo and circus animals will be brought further under the HSNO regime.

Mr Speaker, to improve knowledge of Treaty of Waitangi and tikanga Maori elements in decision-making by ERMA, provision is made to formalise the role of the ERMA’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 HSNO Act. These include certain developments using human cells in culture, requiring approval for regeneration of new organisms from tissue, ensuring consistency in dealing with confidential information. Finally, my ‘backstop’ ability to call-in applications to ERMA will be extended to cover significant cultural, spiritual or ethical effects.

Mr Speaker the provisions I have outlined represent complex and significant changes to the HSNO 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, Mr Speaker, 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. The risk management approach taken in this Bill complements and builds on that of the HSNO Act and is appropriate for the management of new organisms.
Mr Speaker, it is almost two 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. The bill also supplies the incentives for applicants to keep the conditions that may get set.