Recommendations
15.
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15.
Recommendations
In this chapter, we set out all our recommendations in a consolidated list, noting
the chapters in which they appear.
Chapter 6: Research
Recommendation 6.1
that applications to develop genetically modified organisms in
PC1 and PC2 containment be assessed by the Institutional
Biological Safety Committees (IBSCs) on a project rather than
organism basis.
Recommendation 6.2
that all approval forms, standards and regulations relating to the
development of genetically modified organisms in
containment be reviewed and updated.
Recommendation 6.3
that a separate, simplified form be developed for low-risk
(Categories A and B) applications to IBSCs.
Recommendation 6.4
that the Hazardous Substances and New Organisms Act 1996
(HSNO) be amended to allow for the efficient importation of
low-risk genetically modified organisms, through delegation of
the approval process to the IBSCs.
Recommendation 6.5
that approvals to develop or import genetically modified
organisms be deemed to cover their holding and breeding.
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Recommendation 6.6
that HSNO be amended to clarify that research involving
genetic modification of human cell lines or tissue cultures is
covered by the Act.
Recommendation 6.7
that approval for development of genetically modified animal
cell lines be delegated to the IBSCs.
Recommendation 6.8
that HSNO be amended to provide for a further level of
approval called conditional release.
Recommendation 6.9
that HSNO be amended to cover procedures used in mammalian
cloning, such as nuclear transfer or cell fusion.
Recommendation 6.10
that IBSCs include at least one Maori member, appointed on
the nomination of the hapu or iwi with manawhenua in the
locality affected by an application.
Recommendation 6.11
that the funders of research portfolios be resourced to include
the costs of compliance with HSNO.
Recommendation 6.12
that the Environmental Risk Management Authority (ERMA)
require research on environmental impacts on soil and
ecosystems before release of genetically modified crops is
approved.
Recommendation 6.13
that public research funding be allocated to ensure organic
and other sustainable agricultural systems are adequately
supported.
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Recommendation 6.14
that public research funding portfolios be resourced to include
research on the socio-economic and ethical impacts of the
release of genetically modified organisms.
Chapter 7: Crops and other field uses
Recommendation 7.1
that, prior to the release of any Bt-modified crops, the
appropriate agencies develop a strategy for the use of the Bt
toxin in sprays and genetically modified plants, taking into
account:
* the concept of refugia
* limitations on total planted area
* home gardener use.
Recommendation 7.2
that the appropriate agencies develop a labelling regime to
identify genetically modified seed, nursery stock and
propagative material at point of sale.
Recommendation 7.3
that the Ministry of Agriculture and Forestry (MAF) develop a
strategy to allow continued production of genetic
modification-free honey and other bee products, and to avoid
cross-pollination by bees between genetically modified and
modification-free crops, that takes into account both
geographical factors (in terms of crop separation strategies)
and differences in crop flowering times.
Recommendation 7.4
that, in connection with any proposal to develop genetically
modified forest trees, an ecological assessment be required to
determine the effects of the modification on the soil and
environmental ecology, including effects on soil
microorganisms, weediness, insect and animal life, and
biodiversity.
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Recommendation 7.5
that, wherever possible, non-food animals, or animals less
likely to find their way into the food chain, be used as
bioreactors rather than animals that are a common source of
food.
Recommendation 7.6
that, wherever possible, synthetic genes or mammalian
homologues of human genes be used in transgenic animals to
avoid the use of genes derived directly from humans.
Recommendation 7.7
that MAF develop an industry code of practice to ensure
effective separation distances between genetically modified
and unmodified crops (including those grown for seed
production), such a code:
* to be established on a crop-by-crop basis
* to take into account
­ existing separation distances for seed certification in
New Zealand
­ developments in international certification standards for
organic farming
­ emerging strategies for coexistence between genetically
modified and unmodified crops in other countries
* to identify how the costs of establishment and maintenance
of buffer zones are to be borne.
Chapter 8: Food
Recommendation 8.1
that the Food Administration Authority monitor research
studies on stock feed and act on any that indicate a need for
stock feed to be assessed in relation to human health.
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Recommendation 8.2
that Government facilitate the development of a voluntary
label indicating a food has not been genetically modified,
contains no genetically modified ingredients and has not been
manufactured using a process involving genetic modifification.
Recommendation 8.3
that, as a matter of priority, the Food Administration
Authority disseminate information on the labelling regime for
genetically modified foods and consumer rights in relation to
foods made available for consumption at restaurants and take-
away bars.
Recommendation 8.4
that the Food Administration Authority produce and distribute
consumer information on the use of gene technology in the
production of food.
Chapter 9: Medicine
Recommendation 9.1
that all gene therapy, whether in the public or the private
sectors, require formal medical ethical oversight.
Recommendation 9.2
that Toi te Taiao : the Bioethics Council develop ethical
guidelines for xenotransplantation involving genetic
modification technology.
Recommendation 9.3
that products be clearly defined in legislation as medicines,
pharmaco foods, functional foods or dietary supplements.
Recommendation 9.4
that imported medicines and pharmaco foods that include live
genetically modified organisms be approved for use by
Medsafe without a requirement for additional approval from
ERMA.
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Recommendation 9.5
that, in respect of applications for approval as Animal
Remedies of genetically modified organisms or products
manufactured by processes using genetic modification
techniques, the specified information which the Director-
General of Agriculture and Forestry requires to be contained in
applications under the Agricultural Compounds and Veterinary
Medicines Act 1997 (ACVM) include full information on the
efficacy and the form of the genetic modification used in
manufacture; and
that such information be included as one of the categories of
relevant risks and benefits under section 19 of the Act.
Recommendation 9.6
that, as protocols identify useful therapeutics for serious
disease control, approvals through ERMA and Medsafe be
sought in advance for the importation of live genetically
modified organisms in the form of vaccines.
Chapter 10: Intellectual property
Recommendation 10.1
that the New Zealand Plant Variety Rights Act 1987 be
amended to introduce the concept of essential derivation.
Recommendation 10.2
that the Patents Act 1953 be amended by adding a specific
exclusion of the patentability of human beings and the biological
processes for their generation, in line with section 18 of the
Patents Act 1990 (Commonwealth).
Recommendation 10.3
that a Maori Consultative Committee be established by the
Intellectual Property Office of New Zealand to develop
procedures for assessing applications, and to facilitate
consultation with the Maori community where appropriate.
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Recommendation 10.4
that New Zealand be proactive in pursuing cultural and
intellectual property rights for indigenous peoples
internationally.
Recommendation 10.5
that New Zealand pursue the amendment of the World Trade
Organization Agreement on Trade-Related Aspects of
Intellectual Property Rights and associated conventions to
include a reference to the avoidance of cultural offence as a
specific ground for exclusion or reservation.
Recommendation 10.6
that all parties concerned work to resolve the WAI 262 and
WAI 740 claims currently before the Waitangi Tribunal as soon
as possible.
Recommendation 10.7
that HSNO and ACVM be amended to give appropriate
protection to all commercially sensitive or confidential
supporting information provided with applications for
approval.
Chapter 11: Te Tiriti o Waitangi
Recommendation 11.1
that section 8 of HSNO be amended to provide that effect is to
be given to the principles of the Treaty of Waitangi.
Chapter 12: Liability issues
Recommendation 12.1
that Toi te Taiao : the Bioethics Council, in association with
the Human Rights Commission, address the issue of genetic
discrimination.
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Recommendation 12.2
that for the time being there be no change in the liability
system.
Chapter 13: Major conclusion
Recommendation 13.1
that the methodology for implementing HSNO section 6(e) be
made more specific to:
*
include an assessment of the economic impact the release of
any genetically modified crop or organism would have on the
proposed national strategy of preserving opportunities in
genetically modified and unmodified agricultural systems
*
allow for specified categories of genetically modified crops
to be excluded from districts where their presence would be
a significant threat to an established non-genetically
modified crop use.
Recommendation 13.2
that before the controlled or open release of the first
genetically modified crop, the Minister exercise the call-in
powers available under HSNO section 68 in order to assess the
likely overall economic and environmental impact on the
preserving opportunities strategy.
Recommendation 13.3
that MAF develop formalised local networks to encourage
constructive dialogue and communication between farmers using
different production methods, and to provide for mediation where
necessary.
Recommendation 13.4
that sterility technologies be one tool in the strategy to
preserve opportunities, especially in the case of those
genetically modified crops most likely to cross-pollinate with
non-genetically modified crops in the New Zealand context
(eg, brassicas, ryegrass, ornamentals).
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Chapter 14: The biotechnology century
Recommendation 14.1
that HSNO section 68 be extended to include significant
cultural, ethical and spiritual issues as grounds for the
Minister's call-in powers.
Recommendation 14.2
that Government establish Toi te Taiao : the Bioethics Council
to:
* act as an advisory body on ethical, social and cultural
matters in the use of biotechnology in New Zealand
* assess and provide guidelines on biotechnological issues
involving significant social, ethical and cultural dimensions
* provide an open and transparent consultation process to
enable public participation in the Council's activities.
Recommendation 14.3
that Government establish the office of Parliamentary
Commissioner on Biotechnology to undertake futurewatch, audit
and educational functions with regard to the development and use
of biotechnology in New Zealand.
Recommendation 14.4
that the Ministry of Research, Science and Technology develop
on a consultative basis a medium- and long-term
biotechnology strategy for New Zealand.