Māori Membership of Institutional Biological Safety Committees (IBSCs)
Introduction
1. The policy set out below is based on the approach to Māori membership of IBSCs recommended by the Royal Commission on Genetic Modification and agreed to by the Government. This approach is that IBSCs include at least one Māori member, appointed on the nomination of the hapū or iwi with mana whenua in the locality covered by an application. The policy sets out the practical steps for achieving this.Principal policy requirements
2. The principal requirement is that there should be at least one
Māori member appointed to each IBSC on the nomination of the iwi or
hapū with mana whenua in the location of the IBSC. 3. Mana Whenua is defined in this context as all those iwi or hapū who have customary authority through whakapapa, ahi ka roa (long standing occupation) and/or who are well recognised in the broad geographical location of the IBSC.
4. Where there are a number of iwi or hapū existing within the location of the IBSC, the IBSC institution will be encouraged to develop a direct consultative relationship with all interested hapū and iwi, or to establish a consultative committee on which all hapū and iwi groups are represented.
5. If an institution has regionally based stations with their own IBSCs, it is the locality of the particular IBSC that should determine which iwi or hapū group/s should have the right to nominate or be included by other means.
6. This policy will automatically apply unless the institution seeks and is granted an exemption from the Authority.
Exemptions and variations from the principal policy requirement
7. Institutions may apply in writing to the Chief Executive of ERMA
New Zealand for an exemption or variation. Details of the
requirements for applying for exemption will be provided separately
on request. Decisions regarding exemption applications will be made
by the full Authority, in consultation with Ngā Kaihautū. 8. Until or unless an exemption is granted, the requirement set out in (2-6) above will apply. If the requirement is unable to be met or until it is met, the IBSC will not have an operable delegation, and all applications must either be referred to ERMA New Zealand or referred to an IBSC which does have an operable delegation.
9. The Authority will be especially reluctant to grant exemptions if the IBSC intends to consider applications which involve endemic flora and fauna. If cases like this are put forward, the Authority reserves the right to exclude endemic flora and fauna from the scope of the delegation.
10. In considering whether or not to grant an exemption the Authority will consider the extent to which “every reasonable endeavour” has been made to secure a nomination. Reasonable endeavours in this regard should extend to endeavours toward face to face consultation with the potentially involved hapū and iwi over a period of time, i.e. not just a single attempt. An exemption will be considered if, despite every reasonable endeavour:
(a) the local Māori community does not wish to or does not take any action toward, nominating a Māori member meeting the criteria; or
(b) there is a dispute within the Māori community over who has mana whenua or who has mandate. It is for the Māori community itself to resolve issues of this nature.
11. In the event that reasonable endeavours are not successful, other action will still be expected as an alternative and this may include:
(a) The appointment of a Māori member at the initiative of the institution, but having regard to the criteria and those views that have been expressed by local hapū and iwi;
(b) The establishment of other relationships with the local Māori community that will provide a similar level and quality of input.
Other Consultation Requirements
12. It is recognised that particular difficulties arise if the
research requiring an IBSC approval is to be done in one location,
i.e. at the institution, but involves native flora and fauna which
come from another location or with even greater difficulty from
throughout New Zealand. 13. In cases like this it is not required, but still desirable that the IBSC contain Māori members who are nominated from both points of view. However, it would be sufficient for the Māori member to be that nominated by the iwi and hapū in the locality of the IBSC, but for input from other Māori affected to be gathered through the process of consultation.
14. The latter is the responsibility of the applicant and the IBSC, and not specifically of the nominated Māori member.
Consultation Requirements with the Māori Community
Introduction
1. The policy set out below applies to all GMO development
applications made under Section 43 and 43A of the Act, i.e.
applications which conform with the low-risk criteria in the
Low-Risk Regulations. 2. Such applications may be made to either an Institutional Biological Safety Committee (IBSC) or to the Chief Executive of ERMA New Zealand, provided that the Authority has made a delegation for this purpose. The IBSC or the Chief Executive are referred to as the “decision-maker” in the text below. The requirements for consultation are the same for applications considered by either decision-maker.
Requirements for consultation
3. In terms of this policy, “consultation” is defined as:“a process of genuine and informed dialogue intended to create understanding and knowledge of the views of the parties on a particular subject”.
4. The obligation to consult rests primarily with the applicant. If consultation is not in conformity with the guidelines then the decision-maker should either decline the application or return it to the applicant for further work to make good the deficiency, i.e. the applicant should be allowed to withdraw the application and resubmit.
5. Consultation is a two way (at least) process. The obligation to consult requires that every reasonable endeavour is made to do so. Reasonable endeavours require multiple, not single, attempts to establish a dialogue. Reasonable endeavours require attempts at face to face meetings, not just written correspondence. However, it is accepted that on occasion reasonable endeavours will not succeed and, under those circumstances, the obligation shall be considered to have been discharged. However, the circumstances of such attempts must be documented so they are available for audit.
Circumstances under which the requirement to consult is waived
6. The requirement to consult on individual applications is waived
if there is agreement and understanding, between the institution and
the relevant local Māori community, on what type of work is not of
concern. However, any such agreement must be documented, e.g. in the
form of an MOU, and will be subject to audit by the parties and by
ERMA New Zealand7. The need to consult may also be waived if the IBSC has a member, or has in other ways formally involved Māori individuals who are mandated to speak on behalf of the relevant local Māori community. Wider consultation with the Māori community will only be necessary if advised by the mandated individual.
Circumstances requiring mandatory consultation if a waiver does not
apply
8. Under the following circumstances, consultation must occur with
the Māori community prior to a decision being made on an application
to an IBSC or to the Chief Executive:(a) Work that involves DNA from native flora and fauna.
(b) The import and/or development of human DNA or human cell lines of Māori origin.
[This requirement applies to the use of a human cell as the host (which is unlikely to occur under the HSNO Act), or more commonly to the use of human DNA as the donor material. It does not apply to the use of human cells that are not genetically modified, because such cells are not in themselves subject to the HSNO Act.]
(c) Work that involves human embryonic stems cells regardless of their source.
[Further detail regarding points (b) and (c) are provided in the policy Requirements for Consultation with Māori on HSNO Applications that Involve Human Cell Lines and/or Human DNA.]
9. Consultation is also mandatory when DNA from traditional varieties of taonga tuku iho or DNA that is from other valued species are involved, where the following additional criteria are met:
(a) the species that are deemed to be taonga tuku iho or valued have been agreed between the applicant institution and the relevant Māori community, through a proper process of consultation;
(b) this agreement is documented to the satisfaction of the parties and the documentation is provided to the decision-maker.
Circumstances under which dialogue that is less formal than
consultation may be appropriate
10. The difference between informal dialogue as set out in this
section and formal consultation, is that in the former case the
provisions of paragraph 15 do not apply.11. There must be at least informal dialogue with the local Māori community on the use of DNA from microorganisms, unless it can be clearly established that the microorganisms are introduced and not native. This dialogue should be directed towards determining one of the following positions:
(a) the local Māori community has no interest in the specified microorganisms, for any application;
(b) there may be interest in regard to particular applications so informal dialogue should continue to occur;
(c) the microorganisms are to be given “valued” status so formal consultation is required on applications.
12. There are a wide variety of other situations in which informal dialogue may be appropriate. Dialogue may be particularly appropriate if the Māori community has an interest in GMO development work but is not fully aware of the “low-risk” nature of work covered by rapid assessment and what this means in practice. A further example will arise where import or development applications are likely to lead to field trial or release – as early dialogue is advisable to ensure time pressures and efficiencies for both parties can be incorporated. Applicant institutions are encouraged to be as open as possible in this regard, and to be inclusive in their approach.
Who should be consulted?
13. Consultation is likely to be locally based, not nationally
based. Thus unless special circumstances apply, such as the sourcing
of DNA from throughout New Zealand, there is no requirement to
undertake national consultation for low-risk GMO development
applications. 14. Consultation should occur with the hapū or iwi with mana whenua for the locality where the research is based. If material involving DNA from organisms found naturally in New Zealand, whether used as the host or as donor DNA, is sourced from localities other than where the research is based, consultation must also occur with mana whenua in the locations from which the DNA is sourced.
Dealing with the results of consultation
15. The results of formal consultation must be dealt with as
follows:(a) Where Māori want special conditions to be incorporated for cultural reasons, then as far as is judged practicable by the decision-maker those requests should be complied with. The question of what is practicable will vary from case to case.
(b) If Māori object to the work following consultation, including proposals to apply certain conditions designed to meet those objections and provided that the objection is not a general objection to genetic modification, then the decision-maker must either decline the application or refer it to the Authority for a full assessment