Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill 2001, First Reading Notes

Mr Speaker, I move that the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill be now read a first time. At the appropriate time, I intend to move that the Bill be referred to the Finance and Expenditure Select Committee for consideration. This is because the government does want to ensure all parties in Parliament have every opportunity to consider this Bill. The Committee I refer to is of course the only one on which members from every party sit. I will request that the Select Committee report back by mid March 2002 and that the Committee have the authority to meet at any time while the House is sitting (except during oral questions), 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, the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill is one of the key government decisions in response to the report of the Royal Commission on Genetic Modification. For those of you familiar with the Royal Commission’s report, you will know it concluded that the basic regulatory framework for managing genetic modification technology is appropriate, and the key institutions do carry out their functions conscientiously and soundly. The Royal Commission made suggestions for change, most of which the government has decided to implement as part of the strategy of “preserving opportunities while proceeding with caution”. However, the government has decided that while research into the impacts of genetically modified organisms is undertaken, and changes are made to the HSNO Act, there should be no releases of genetically modified organisms into the New Zealand environment. The government has also decided to ensure that strict containment is applied in every case where research involves field testing. This is because the government has come to the view that the various conditions that ERMA has chosen to place on field tests in the past should continue to be placed on field tests in the future, but from now on because the law requires it, ie they must place those conditions on.

The amendments I want to refer to can be grouped into four categories:
·Amendments that relate to provisions for field testing of genetically modified organisms
·Amendments that restrict for two years the consideration and approval of applications to release genetically modified organisms
·Amendments that exempt certain applications from the restricted period
·Amendments that provide transitional provisions.

Mr Speaker, the first category I want to refer to are those that relate to provisions for field testing of genetically modified organisms

Clauses 5, 6 and 7 introduce changes to the consideration of applications to field test genetically modified organisms.

The government’s intention is for field tests to continue. They have been carried out in New Zealand for the last 13 years and to date there have been no known adverse effects on the environment. These tests provide valuable information about the behaviour of a genetically modified organism and the effects it might have on the environment. However, the field tests are contained in a way that enables any heritable material arising from the organism to be retrieved or destroyed at the end of the test. The amendments make this level of containment more explicit and mandatory.

The Bill as it stands does not include a definition of heritable material. The term is included in the meaning of field test in the Hazardous Substances and New Organisms Act, and it is included again in these amendments. To date, the Environmental Risk Management Authority has been using a working definition of the term. I invite the Select Committee to consider the desirability of defining heritable material.

I also invite the Committee to consider whether clause 45A(e) could be clarified further, particularly the phrase ‘all material’.

At present the Environmental Risk Management Authority has some discretion to determine all the conditions to be applied to approved research. I would have to say that the Authority has always exercised that discretion in a way that has led to high security on field tests it has approved. However, the Government has decided to make it absolutely clear that all field testing research must meet the strictest containment standards. The majority of the proposed amendments to the field test provisions are making explicit and mandatory what is to a large extent current practice about setting controls under the Hazardous Substances and New Organisms Act. The amendments clarify the level of containment that is expected for contained field tests.

Anyone wishing to field test a genetically modified plant or animal must also provide the Environmental Risk Management Authority with additional information, which must be taken into account in the consideration of the application. The Authority must consider information about the safety and ecological effects of the field test. Furthermore, the Authority must consider any alternative method of achieving the research objectives that is as effective as, or more effective than, the field test. In this way, the Authority has information about alternative research methods.

Mr Speaker, the second group of amendments I want to refer to are those that restrict applications to release genetically modified organisms.

Clause 8 outlines the restrictions on release applications, and the exemptions. The Bill restricts for a two-year period consideration of applications to import for release, or release from containment, genetically modified organisms.

Because we have no genetically modified organisms outside of containment in New Zealand, the first application to release a genetically modified organism will be a significant one. This is especially the case if the application is for a plant or crop, as opposed to a medicine that contains a live genetically modified organism (given that such medicines would generally only be available under prescription and securely held). The government considers that while enhancements are made to the Hazardous Substances and New Organisms Act, research into environmental and socio-economic impacts is undertaken, and coexistence and other policy work progressed, there should be no application made to release a genetically modified organism.

I am able to call in an application if I consider that it will have significant economic, environmental, international or health effects, or if I considered that there were significant effects in an area in which the Authority lacked sufficient knowledge or experience. However, I could only do that after an application was lodged with the Environmental Risk Management Authority, and even if I did call in the application, my decision would be based on the same assessment process that the Authority would use to make its decision. The government did not want to be in a position where it was waiting for that first application to be made, and it certainly did not want to be mid way through the enhancements to the Hazardous Substances and New Organisms Act when a release application came along.

So the amendments in this category will put in a fixed-term restricted period, running from 29 October 2001 to 29 October 2003.

Mr Speaker, the third category of amendments that I want to refer to are those that exempt certain applications from the restricted period.

Exempt from the restricted period are medicines approved under sections 20, 23 or 30 of the Medicines Act 1981, and sections 9 or 26 the Agricultural Compounds and Veterinary Medicines Act 1987. Medicines that contain genetically modified organisms are exempt from the restricted period so as to ensure human health and safety. If, for instance, an important GMO-medicine is needed in New Zealand, it will be able to proceed through the Hazardous Substances and New Organisms Act application process as well as the approval process for the Medicines Act.

The restricted period does not apply to the emergency provisions of the Hazardous Substances and New Organisms Act.

Clause 8 outlines that for applications to release genetically modified organisms that are exempt from the restricted period, an application must include information showing that the organism cannot persist viably in the physical environment. Furthermore, when deciding on an application the Authority must take into account the safety and ecological effects of the GMO-containing medicine and the efficacy of the medicine compared to other medicines used to treat the same condition.

Mr Speaker, the fourth and final category of amendments I want to refer to are those that provide transitional provisions.

Clause 2 of the Bill is the commencement clause. Although the Bill comes into force on the day after it receives the Royal assent, the amendments in the Bill will have effect from 29 October 2001. Clause 3 is the expiry date. The restricted period on release applications expires on 29 October 2003, but the changes to field test applications are ongoing. Because the Bill takes effect from 29 October, it outlines in clause 9 the transitional provisions for situations where an application to field test a genetically modified organism is made and an approval granted between now and the time the Bill comes into force. These dates have been widely announced by the government so anyone who puts an application in, does so in the knowledge of the changes contained in this Bill.

If a field test application is received during the transitional period, and the Authority approves it, this Bill then requires the Authority to review the approval against the additional requirements contained in the Bill. Depending on the result of this review the Authority may either cancel the approval, or include additional controls or substitute controls.

Mr Speaker, this Bill is a key element in the government’s comprehensive response to the report of the Royal Commission on Genetic Modification. More importantly it is a key part of implementing the approach, which the Royal Commission recommended. That is an approach of preserving opportunities while proceeding with caution.