Executive Summary

June 2003

Toi te Taiao: The Bioethics Council ("the Council") regards the Royal Commission on Genetic Modification as the key body which, through an extensive democratic process, charted the overall course for genetic modification in New Zealand for the foreseeable future.

The Council sees its role in relation to genetic modification as building upon the work of the Royal Commission rather than revisiting that work.

The Council has a particular responsibility for considering how ethical, cultural and spiritual concerns are accommodated within the Commission's key recommendation of 'preserving opportunities'.

The Royal Commission made it clear that many New Zealanders believe ethical, spiritual and cultural matters should be taken into consideration when deciding on applications under the Hazardous Substances and New Organisms Act ("HSNO").

The Council strongly supports the Biotechnology Strategy statement: "The regulatory framework is where innovation and opportunity meet society's safety and ethical concerns. The challenge is to ensure an appropriate balance."

The Council is strongly of the view that ethical, spiritual, and cultural matters should be part of the mainstream decision-making process, as an integral component of the processes of ERMA ("the Authority").

The Council has no role in dealing with submissions made to ERMA, even if these concern ethical, spiritual, and cultural matters which the submitter believes to be relevant to a particular application.

The Bioethics Council has a role in providing the big picture context and developing guidelines, principles and frameworks, which need to be applied and interpreted in the context of particular situations.

The New Organisms and Other Matters bill ("NOOM") needs to ensure that HSNO clearly provides for the integration of those principles, guidelines and frameworks into the case-by-case decision-making of the Authority.

Providing the legislative base for this integration requires changes to NOOM to ensure that ethical, spiritual and cultural dimensions are incorporated into the following sections of HSNO: section 6 (Matters relevant to the purpose of the Act); Section 16 (Matters to be considered in regard to eligibility for appointment as a member of the Authority); Section 36 (Minimum standards).

The provision of more effective means of handling ethical, spiritual and cultural effects within ERMA's decision-making processes may well reduce perceived barriers to applications rather than creating them.

The actual translation of the legislation into the Methodology and operations of ERMA is a matter for the Authority to determine, but the Council stresses the need for processes and/or structures to ensure any overarching principles/guidelines it provides can be applied at the case-by-case level.

The Council supports Clause 36 of the bill which extends ministerial call-in powers to include significant ethical, spiritual and cultural effects, but sees call-in as an additional provision, not the only provision, for dealing with ethical, cultural and spiritual issues.

Legislated provision for conditional release allows for a more cautious approach than currently provided for in HSNO, and hence a better ability to protect the environment and human communities from any potential harm. The Council supports the provision for conditional release.

The Council recommends that NOOM be amended to ensure that HSNO requires any full release to be preceded by an appropriate period of conditional release.

The Council sees the provision for conditional release as the key factor which provides the safeguards that would allow the moratorium to be removed in October this year.

New Zealand has chosen a path of separation and coexistence, which depends upon clear identification and separation of GMOs and their products at the growing, processing and marketing stages. The Council recommends that in the proposed new Section 38 of HSNO this matter of maintenance of consumer choice be included with other controls.

The Council supports the proposals in Clauses 9,12, and 26 for streamlining ERMA's application processes.

The Council is in strong agreement with the amendments proposed in Clause 5 which will ensure human cells and regeneration from tissue of animals not present in New Zealand are covered by the HSNO Act.

The Council submits that a key aspect to giving greater effect to the Treaty of Waitangi through HSNO is ensuring that Maori have a legislated proper place in decision-making.

The Council supports the action of ERMA in setting up Nga Kaihautu Tikanga Taiao and believe it is now appropriate to change the HSNO Act as set out in Clause 10 of NOOM, to ensure Nga Kaihautu Tikanga Taiao continues as an integral part of ERMA.

The Council strongly recommends that HSNO Section 8 be changed to "shall give effect to the principles of the Treaty of Waitangi", in line with the Royal Commission's recommendation on this matter.

The Council welcomes and strongly support Clause 8 of the bill which includes "...matters relating to the Treaty of Waitangi and tikanga Maori" in the eligibility factors for appointment to the Authority.

Clause-by-clause Recommendations

The Council does not wish to see any clauses deleted from the New Organisms and Other Matters bill.

We recommend the following additional clauses and amendments to clauses:

Additional clauses to be Included in NOOM

1. A clause which ensures that Section 6 of HSNO includes a further 'matter relevant to the purpose of the Act', as follows:
(g) The cultural, ethical and spiritual effects of the introduction of a new organism.

2. A clause which ensures Section 8 of HSNO is changed to "shall give effect to the principles of the Treaty of Waitangi".

3. A clause which ensures that Section 36 of HSNO includes an additional minimum standard relating to ethical, cultural and spiritual dimensions of an application.

4. A clause which requires that any full release be preceded by an appropriate period of conditional release.

5. A clause which provides for the Chairperson of Nga Kaihautu Tikanga Taiao to have a place with Authority members on the Board of ERMA.

Amendments to clauses in NOOM

6. Amend Clause 8 to ensure that Section 16 of HSNO includes a further matter to be considered in regard to eligibility for appointment as a member of the Authority, as follows:
When considering whether a person is suitable to be appointed as a member of the Authority, the Minister shall ensure that the membership includes a balanced mix of knowledge and experience in matters likely to come before the Authority, including knowledge and understanding of cultural, ethical and spiritual issues.

7. Amend Clause 10 to ensure that consultation with iwi and hapu is part of the review of the Terms of Reference of Nga Kaihautu Tikanga Taiao.

8. Amend Clause 18 (proposed new section 38 in HSNO) to ensure that the maintenance of consumer choice through identification and separation of genetically-modified organisms in both the growing and processing stages can be addressed through the controls that ERMA may impose.