Analysis of Public
Submissions
Analysis of
Public Submissions
3.
section 3.15 |
appendix 3
Outcomes of Consultation: Submissions
from the Public
Section contents
3.
Analysis of Public Submissions
22
3.15 Comment on policy, process and regulation provided
through public submissions by public sector
organisations
116
Background
116
Australia New Zealand Food Authority
117
Department of Conservation
120
Human Rights Commission
122
Institute of Environmental Science and Research
124
Ministry of Agriculture and Forestry
126
Ministry of Consumer Affairs
129
Ministry of Economic Development
130
Ministry of Foreign Affairs and Trade
133
Ministry of Health
135
Te Puni Kokiri
136
Royal Commission on Genetic Modification | Report Appendix 3
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Report Appendix 3 | Roy al Commission on Genetic M odification
3.15 Comment on policy,
process and regulation
provided through public
submissions by public sector
organisations
Background
Certain government departments and agencies made submissions to the Royal
Commission through the public submission process. These organisations either
had not sought or were not granted Interested Person status with the Commission.
The submissions by public sector organisations provided extensive information on
the work of the organisations where they had been involved in genetic modification
or biotechnology issues and on policy, processes, legislation and regulation
relating to genetic modification. The Commission received such submissions
through the public process from:
*
Australia New Zealand Food Authority
*
Department of Conservation
*
Human Rights Commission
*
Institute of Environmental Science and Research
*
Ministry of Agriculture and Forestry
*
Ministry of Consumer Affairs
*
Ministry of Economic Development
*
Ministry of Foreign Affairs and Trade
*
Ministry of Health
*
Te Puni Kokiri (Ministry of Maori Development).
A brief summary of information on public sector policy, process and regulation
provided by each of these organisations is provided below, with reference to the
relevant Warrant items where appropriate. (These submissions were received by
the Commission before 1 December 2000 so this commentary does not reflect
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Royal Commission on Genetic Modification | Report Appendix 3
recent developments in regulation and policy, eg strengthening of border control
measures. For up-to-date details, contact the organisations directly.)
Full texts of all but one of these submissions are publicly available on the
Commission website (http://www.gmcommission.govt.nz) until 30 June 2002. The
submission from the Institute of Environmental Science and Research included
some confidential sections that were not placed on the website: the public part is
available.
Australia New Zealand Food Authority
The submission by the Australia New Zealand Food Authority (ANZFA) does not
specifically respond to any of the Warrant items but rather is provided in two parts.
The first part sets out the role of ANZFA, its establishment under the agreement
between New Zealand and Australia establishing a system for the development of
joint food standards (the Treaty) and the policy and processes to review and
develop food standards and the regulations. The second part of the submission sets
out the history and current practice for the regulation of genetically modified food
in New Zealand and in Australia. The submission closes with ANZFA's position as
a member of the international community involved in the investigation and
regulation of genetically modified foods and some thoughts as to the future
directions and implications for genetically modified foods.
ANZFA also supplied a set of attachments (obtainable from the ANZFA website,
http://www.anzfa.govt.nz) ranging from the Australia New Zealand Food Authority
Act 1991 and the Treaty mentioned above to specific applications and to
international guidelines concerning genetically modified foods.
ANZFA is a statutory authority established by an Act of the Commonwealth
Parliament of Australia with a bi-national function in the food standards area. It
conducts scientific risk assessments and consults with community and stakeholders
before making recommendations to the Australia New Zealand Food Standards
Council (ANZFSC) concerning proposed amendments to the foods standards
code.
As at September 2000, ANZFA had received 20 applications to approve genetically
modified food commodities, two of which had been withdrawn after application
and two of which (Roundup Ready soybeans and Ingard cotton) have been
approved for inclusion in Standard A18: Food Produced Using Gene Technology.
The ANZFSC determined to amend Standard A18 requiring provisions for the
labelling of all genetically modified foods on 28 July 2000. This standard becomes
compulsory in 2001.
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Also in 2001, ANZFA will be replaced by a new organisation, Foods Standards
Australia New Zealand, which will have similar functions and responsibilities.
The ANZFA process for review and development of food standards
ANZFA's objectives in developing food regulations are set out in section 10 of the
ANZFA Act and in Annexe A of the Treaty. These are:
*
protection of public health and safety
*
provision of adequate information to enable consumers to make informed
choices
*
prevention of misleading or deceptive conduct.
In making recommendations to ANZFSC, ANZFA must also have regard to:
*
the need for standards to be based on risk analysis using best available
scientific evidence
*
the promotion of consistency between domestic and international food
standards
*
the desirability of an efficient and internationally competitive food industry
*
the promotion of fair trading in food.
Applications for ANZFA's proposals for a food standard go through four steps:
*
making a preliminary assessment
*
making a full assessment report based on scientific risk assessment
*
conducting an inquiry into any resultant draft standard or variation
*
making a recommendation to ANZFSC.
ANZFA comments that the bi-national operation of ANZFA is unique. The joint
code will provide the New Zealand and Australian food industries with a common
set of regulations covering food manufacture. Essentially, the Treaty means that
the Australian and New Zealand food industries are one and the same, with a
market of 23 million people in total. ANZFA has two New Zealand members on its
Board and a third New Zealand representative was appointed during the transition
process to the new joint Australia New Zealand Food Standards Code.
There is a fully operational New Zealand office based in Wellington. Meetings are
held in both Australia and New Zealand. Consultation takes place in non-
government forums, meetings and workshops and there is special provision for
consultation with Maori. Individual government agencies and the Officials
Committee on Food Administration are also involved in ANZFA's consultation
process. ANZFA must reach agreement with New Zealand on the outputs it must
achieve each year and it reports directly and regularly to the New Zealand
Minister of Health and Ministry of Health.
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Regulation of genetically modified food
ANZFA's submission sets out in some detail the processes and the history of the
regulation of genetically modified food in New Zealand. It also discusses the
labelling of genetically modified food. In 1999-2000 KPMG was engaged by
ANZFA to evaluate the cost implications of any labelling regime. The project was
estimated to be NZ$43 million for one-off or set-up costs for the mandatory
labelling of genetically modified foods based on a process of "due diligence" by
industry and verifiable documentation. A similar amount was estimated for
ongoing compliance costs.
International regulation of genetically modified foods
The ANZFA submission points out that requirements for the safety and labelling
of genetically modified foods vary throughout the world. There is currently no
formal global agreement on how food sourced from genetically modified organisms
or containing genetically modified substances should be treated.
As members of the World Trade Organization (WTO), both Australia and New
Zealand have notified it regarding the development of and amendments to
Standard A18.
Australia and New Zealand also recognise the Codex Alimentarius Commission
(CAC) as the appropriate body for setting international food standards, including
those applying to genetically modified foods. CAC is currently considering safety
and labelling issues relating to genetically modified foods. ANZFA has been an
active participant in each of the Codex groups as an invited member of the
Australian delegations. Although ANZFA does not speak for New Zealand at these
meetings, it notes there has been close collaboration between New Zealand and
Australian delegations at the group meetings. The Codex process for finalisation
of international documents and standards relating to safety of foods derived from
biotechnology is on a four-year time limit set to conclude in 2004. The Codex
process for labelling standards for genetically modified foods may also take at least
this long.
Future directions
In conclusion, ANZFA notes that future directions in the development of
biotechnology will have significant impact on and present many challenges for
regulatory authorities such as ANZFA. ANZFA identified some of these issues as
including:
*
continuing high levels of consumer and community interest in genetically
modified foods and potential health impacts
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*
an increasing number of genetically modified foods with new properties
which may provide benefits to consumers in taste, shelf-life and nutrition
*
the development of genetically modified foods with therapeutic effects
(ANZFA notes these will require careful consideration and will create
challenges for food and therapeutic goods regulatory authorities in
coordinating regulatory action)
*
international developments of agreed protocols and arrangements for the
regulation of genetically modified foods
*
the need for careful monitoring and evaluation of potential and unforeseen
health effects from both the current and future range of genetically modified
foods available commercially.
Department of Conservation
The Department of Conservation (DOC) was established under the Conservation
Act 1987 with responsibility for conservation management and advocacy and for
the preservation and protection of indigenous flora and fauna. It is responsible for
advising the Minister for Biosecurity on risks to indigenous flora and fauna and has
a small operational biosecurity role under the Biosecurity Act 1993 (such as
eradication and control of Undaria around Stewart Island and certain weed and
pest control activities).
Points raised in the submission related to Warrant items (a), where, how and for
what purpose ..., (c), risks and benefits, (f), intellectual property issues, (j), main
areas of public interest and (n), statutory and regulatory processes.
Main areas of public interest: environmental matters
Exotic species have had dramatic effects on New Zealand's biodiversity. Invasive
exotic pests are the greatest single threat to our remaining natural ecosystems,
habitats and species. They damage habitats and ecosystem processes and pose high
costs and threats to productive ecosystems.
The Department spends over half of its total budget on protecting natural heritage
and most of this is spent on weed and animal pest control and threatened species
protection work. Conventional pest and weed control is labour intensive and
expensive. Despite a recent funding package for pest and weed control on public
land, DOC is restricting pest control to priority areas and mostly is limited to
"holding the line" until new pest control techniques are developed. The
Department needs to explore new options, particularly as public attitudes are
hardening towards use of pesticides and herbicides.
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Conventional biological control (biocontrol) uses a natural enemy to control a
pest or weed population. Examples include Lochmaea suturalis to control heather
in Tongariro National Park, parasitoids for wasp control and Procecidochares alani
to control mist flower. Biocontrol releases for new organisms are considered
under the Hazardous Substances and New Organisms (HSNO) Act by the
Environmental Risk Management Authority (ERMA).
DOC notes that it manages New Zealand's ecosystems and species on behalf of
all New Zealanders and that any potential use of genetic technology for
conservation purposes would have to be within the bounds of what the wider
community sees as reasonable.
Risks and benefits
From a conservation perspective on requirements to be met before the release of
new organisms, DOC advocated risk assessment on native species and ecosystems,
minimum environmental standards and a precautionary approach.
There are many possible risks from introduction of new organisms into the
environment. For example, there is a risk to native insects from bacterial
endotoxins from Bt (Bacillus thuringiensis) incorporated into many genetically
modified plants and of the toxins building up in the soil and killing soil insects.
Statutory and regulatory processes
The HSNO Act sets minimum standards. These are a statement of a level of risk
considered unacceptable. Regardless of potential benefits, DOC would oppose any
introduction of a genetically modified organism if these minimum standards were
not met. Moreover, where there is uncertainty, the precautionary approach should
be applied.
DOC has a statutory role to advise on new organisms considered for introduction
and their impacts. Under s 53(4) of the HSNO Act, ERMA must notify DOC of
applications for approval of new organisms and must have particular regard to the
Department's views (s 58). DOC has requested significant changes in applications
to field-test genetically modified organisms, for example, petunias and maize.
DOC notes that there is no scientific consensus as to the seriousness, or even
existence, of potential harm from genetic modification technology. It therefore
asks whether there is any advantage in postponing decisions on release of
genetically modified organisms into the New Zealand environment until there is a
larger body of information on their effects on the environment and on biodiversity.
And it also raises the issue of whether case-by-case assessment adequately takes
into account the cumulative and synergistic effects of multiple releases.
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Where, how and for what purpose ...
The submission provides examples on DNA technology that helps to identify
species and assist in conservation work, eg the differentiation of two species of
brown kiwi, Apteryx australis and Apteryx mantelli, and how future application of
genetically modified organisms could improve conservation work and pest control.
Intellectual property issues
DOC notes that New Zealand currently has no statutory management framework
for bioprospecting. The Department has informally placed a moratorium on
issuing permits to collect flora and fauna from public conservation lands for
bioprospecting purposes. However, private landowners may allow this, except for
animals protected under the Wildlife Act or conservation legislation.
The Department notes that the issue of ownership and access to benefits derived
from New Zealand's biological and genetic resources has been raised by the WAI
262 claim to the Waitangi Tribunal.
Human Rights Commission
The functions of the New Zealand Human Rights Commission relate to the
promotion and protection of human rights in accordance with various international
covenants and conventions. The Human Rights Commission took a neutral stance
on the risks or benefits associated with genetic modification. The focus was
primarily on Warrant item (j), main areas of public interest: human health, with
some commentary on legislation referring to Warrant item (n), statutory and
regulatory processes.
The submission raised the following issues of significance or concern.
Attention to New Zealand's domestic and international human rights obligations
should be part of considering strategic options on genetic modification. These are
covered by:
*
Universal Declaration of Human Rights 1948
*
International Covenant on Economic, Social and Cultural Rights 1996.
The right to health is also included in:
*
International Convention on the Elimination of All Forms of Racial
Discrimination 1965
*
Convention on the Elimination of All Forms of Discrimination against
Women 1979
*
Convention on the Rights of the Child 1989.
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The Human Rights Commission suggests that the Human Rights Act 1993,
which presently prohibits discrimination on 13 specific grounds, should also
cover "genetic discrimination" (the discrimination against individuals on grounds
of their genetic make-up). The submission notes the Council of Europe's 1997
Convention on Human Rights and Biomedicine (Convention for the Protection of
Human Rights and Dignity of the Human Being with Regard to the Application of
Biology and Medicine), which sets out a series of principles and prohibitions such
as:
*
banning discrimination on genetic grounds
*
allowing predictive genetic tests only for medical purposes
*
allowing genetic modification technology only for preventive, diagnostic or
therapeutic reasons and only where it does not change the genetic make-up
of descendants
*
banning use of in vitro fertilisation to choose the sex of a child (except to
avoid serious hereditary conditions)
*
regulation of medical research
*
prohibiting creation of human embryos for research purposes and requiring
adequate protection of embryos where countries allow in vitro research
*
prohibiting profit from the use of any part of the human body
*
requiring informed consent
*
acknowledgement of patients' rights to be informed about their health or to
reject that information
*
banning removal of organs for transplant without consent, except for
regenerative tissue from siblings
*
public debate and consultation.
The Human Rights Commission also refers to the United Nations Educational,
Scientific and Cultural Organization's Draft Universal Declaration on the Human
Genome and Human Rights 1997 with its requirement that individuals should not
be reduced to their genetic characteristics but respected for their uniqueness and
diversity.
The submission also raises the issue of consumer choice. Consumers have the right
to know of the presence of genetically modified organisms or genetically modified
products, particularly in food. The right to such information is provided for by
Article 19 of the International Covenant on Civil and Political Rights (ICCPR), a
United Nations convention ratified by New Zealand in 1976. ICCPR enables
complaints of breaches of the convention to be made by individuals to the United
Nations Human Rights Committee.
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Institute of Environmental Science
and Research
The Institute of Environmental Science and Research (ESR) is a Crown Research
Institute (CRI) that is neither sector- nor resource-based as are the other CRIs. It
presents itself as an independent agency, not involved in genetically modifying
products, plants or animals, with its focus as "protection of people and their
environment through science". ESR provides scientific services in public health,
environmental and forensic sciences with particular capabilities in molecular
technology. The Institute says it has deliberately stood aside from any alignment in
the genetic modification debate to safeguard its scientific independence. ESR
agrees with the general scepticism displayed by New Zealanders about the self-
interest in a science environment driven by the prevailing business model.
In its written submission through the public submission process, ESR dealt mainly
with Warrant items (1), strategic options, (2) and (n), statutory and regulatory
processes, (b), evidence and uncertainty, (c), risks and benefits, (h), global
developments and (j), main areas of public interest.
The submission made the following introductory observations:
*
Biotechnology is rapidly developing worldwide.
*
The `science' is ahead of society's acceptance of its use.
*
Community perceptions of harm must be addressed. These perceptions will
not be influenced solely by more scientific evidence.
*
Assessment and quantification of risks must be from both biophysical and
social science perspectives.
*
A lack of basic research, eg on horizontal gene transfer (HGT) in ecosystems,
hinders development of biotechnology industries.
*
There is a disparity in government research purchased between the areas of
development and environmental risk of genetic technology. Around one-
third of the Public Good Science Fund ($100 million) is invested annually in
molecular technology development but little or none in the area of potential
environmental health effects of using genetic modification in plant and
animal production systems.
*
ESR's particular interest is in the development and validation of methods to
detect genetically modified foods. There is a dearth of information from
long-term feeding trials and ESR recommends that New Zealand should
promote and participate in internationally coordinated and financed research
trials of this kind.
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Further points by Warrant item follow.
Strategic options
ESR sets out three options for New Zealand's genetic modification strategy:
*
Develop and use genetic modification in all sectors and be at the forefront
of developments to move from commodity-based to high value-added
niche markets.
*
Adopt an organic brand for primary production to add value to food-based
products. Where genetic modification is used in sectors such as medicine
and health, ensure informed choice about public use is possible.
*
Develop a framework and guidelines for the coexistence of the first two
options to maximise benefits and minimise risks.
ESR supports the third option.
Evidence and uncertainty
HGT is a natural phenomenon occurring on land and in aquatic environments by
various means. Viable free DNA has been shown to persist in soil for several years
and is therefore available for uptake by microorganisms.
There is increasing evidence that HGT can occur between genetically modified
plants and microorganisms. The submission cites work on transfers of the
hygromycin resistance gene from decaying modified brassica plants to the soil-
borne fungus Aspergillus niger and the kanamycin resistance gene from modified
sugar beet plants to the modified soil bacterium Acinetobacter BD314pFG

nptII. It
suggests that HGT is a rare event but its potential impact on soil ecosystems
cannot be underestimated under supportive environmental pressures.
ESR notes potential ecotoxic effects. Large-scale commercial planting of genetically
modified plants may affect soil `health' directly by modifying microbial population
diversity. Current research results on this have been extremely variable.
Risks and benefits
ESR believes that greater understanding of physical contamination processes such
as HGT is needed to enable a more robust risk assessment. Thus continuing
scientific research could offset the risk of loss of scientific capability offshore posed
by the current delay on the release of genetically modified organisms, which ESR
supports.
Global developments
It is important to maintain international links with overseas researchers to ensure
standardisation of the methodologies used to assess effects of genetically modified
organisms.
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Main areas of public interest: human health
Acceptance of genetically modified medicines is because of public appreciation
of the benefits and more confidence in the regulatory regimes in place to ensure
safety. The food industry, in comparison, has fuelled public concern and distrust
and caused the perception that commercial interests are valued more than public
interests. This is reinforced by food scares concerning bovine spongiform
encephalopathy (BSE).
Main areas of public interest: environmental matters
New Zealand has unique soils and ecosystems. Therefore, genetic modification
impacts must be investigated here and not simply extrapolated from overseas data.
The submission suggests that we must improve our understanding of key adverse
effects of genetically modified plants on the environment in order to be able to
protect New Zealand's flora and fauna from the planned environmental release of
genetically modified plants, animals or other organisms, for example, for biocontrol
purposes.
Main areas of public interest: economic matters
New Zealand's economy is biologically based. To build wealth, New Zealand must
develop strengths it already has in the productive sector and new wealth-creating
enterprises and markets.
Some producers believe they have the `right' to access new technology to develop
new products and markets. Other producers believe organic production is the
future market positioning for New Zealand and that they have the `right' not to be
contaminated by genetically modified organisms.
New Zealand must develop a `coexistence' regime, which provides a regulatory
process that gives people faith in its decision-making and the ability to exercise
their democratic rights.
Ministry of Agriculture and Forestry
The Ministry of Agriculture and Forestry (MAF) in its written public submission
to the Commission dealt particularly with Warrant items (1), (k) and (m), strategic
options, issues and outcomes, (2) and (n), statutory and regulatory processes, (a),
where, how and for what purpose ..., (c), risks and benefits, (h), global developments
and (j), main areas of public interest.
MAF is the New Zealand contact point for the Codex Alimentarius Commission,
which sets international food standards and the WTO's Committee on Sanitary
and Phytosanitary Measures. In addition MAF's regulatory responsibilities include
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biosecurity, food safety in animal and dairy products and a joint role with the
Ministry of Health on the Codex Committee on Food Labelling.
Points made include the following observations, which span multiple Warrant
items.
Statutory and regulatory processes
The submission notes that it is critical for New Zealand's primary producers that
consumers have confidence in the safety of their products. Confidence in the
integrity and reputation of New Zealand's regulatory processes underpin access to
many overseas markets.
The current regulatory system provides mechanisms for weighing up risks and
benefits of new technology. The submission comments on gaps and issues in the
existing regulatory system:
*
The legislation covering new organisms (HSNO Act) does not recognise the
capacity for post-release controls under other legislation administered by
MAF.
*
Ethical approvals are not required for research on animal foetuses under half
way through term.
*
Stockfeeds that are genetically modified products may not require safety
assessments because there is no risk factor specific to genetic modification
that would trigger such an assessment.
Strategic issues, opportunities, global developments
Border control alone cannot guarantee that New Zealand could remain genetic
modification-free.
New Zealand has to operate within the trading framework of the bilateral and
multilateral agreements and commitments between it and its trading partners.
External consumer demands and regulatory requirements will be highly influential
in the profitability of New Zealand's exports of agricultural and forestry products.
There are likely to be opportunities in both genetic modification and non-genetic
modification markets. New Zealand could be seriously disadvantaged if its
producers were locked out of the future opportunities provided by either
technology.
The extent to which genetic modification and non-genetic modification production
can coexist must be critically examined. Any success in this area will depend on the
extent to which consumers can be confident about the separation and integrity of
non-genetic modification supplies.
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Where, how and for what purpose ...
The submission comments that genetic modification has been mainly used as a
research tool in New Zealand but genetically modified crops have been rapidly
adopted in some overseas countries. It provides an account of some of these
commercial applications.
Risks and benefits, statutory and regulatory processes
MAF takes a risk management approach rather than attempting complete
elimination of risk. It comments that the impacts of genetic modification are
unforeseeable.
Managing biosecurity at the border alone is a physical impossibility for genetic
modification. Control at the border will continue to rely on importers obtaining
appropriate approvals from ERMA before importing genetically modified
organisms and for documentation to determine the genetic modification status of
incoming goods.
Containment facilities and operators for genetically modified organisms are
approved under the Biosecurity Act. Containment control is based on standards
approved by ERMA under the HSNO Act and developed by MAF and ERMA
based on the Australia/New Zealand standard AS/NZS 2243.3:1995. MAF
inspects facilities to ensure they meet standards plus additional controls imposed
by ERMA.
Strategy, risks and benefits, main areas of public interest,
statutory and regulatory processes
Should New Zealand decide to prohibit the use of genetic modification in primary
production, a definition of "non-genetic modification" is needed. That could
range from a "due diligence" approach to avoid genetic modification inputs or
mixing to an absolute genetic modification-free proven by audit trails and/or with
testing for genetically modified material.
The definition would have to reflect what standards are realistically obtainable and
enforceable.
The submission comments on environmental risks and benefits from the use of
genetic modification.
Maori views are balanced between significant cultural concern over whakapapa
and tapu issues and as significant stakeholders in agriculture and forestry where
there may be potential economic benefits. MAF feels that Maori, like other New
Zealanders, are still weighing the implications of genetic modification.
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Regulatory systems based on perceptions of risk or ethical considerations:
*
could have unintended consequences unless there were a clear societal
consensus and decisions were made with regard to all known consequences
*
would not be based on scientific assessments of risk or economic assessments
of costs and benefits
*
could create uncertainty for industry and consumers (as perceptions and
values shift over time) and discourage investment
*
could be seen as arbitrary trade barriers.
MAF is concerned to protect the integrity and reputation of New Zealand's
regulatory processes, which are central to gaining and keeping access to export
markets. New Zealand exports have recognition from overseas regulators often
denied trading competitors (eg, a bilateral veterinary agreement with the European
Union accords "equivalence" to New Zealand's regulatory system).
Future values of genetically modified or non-genetically modified products are
dependent on consumer demands. There is no certainty as to their future value.
Given this, the submission asks whether a choice of one production system
precludes the other, or can both production systems coexist? It describes various
methods for keeping genetically modified and non-genetically modified products
separate.
Ministry of Consumer Affairs
The submission by the Ministry of Consumer Affairs (MCA) addressed Warrant
items (c), risks and benefits, and (j), main areas of public interest: human health. It
focused on consumer rights, in particular, consumer safety, choice, information
and education. These rights must underpin any approach to genetic modification,
particularly in relation to food.
Points made included the following observations.
Two key aspects are scope and effectiveness of consumer information on genetic
modification. Without adequate information on issues, consumers cannot choose
whether to purchase genetically modified foods based on their perceptions of risk
or other considerations. Without adequate information through product labelling,
consumers cannot distinguish genetically modified from non-genetically modified
products.
The Australia New Zealand Food Standards Council (ANZFSC) has agreed to a
proposed comprehensive labelling regime based on the presence of novel DNA,
protein or altered characteristics. MCA raises the issue of process labelling as well
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as presence labelling: thus supporting consumers' right to know if the food they
purchase has been subject to gene technology at any stage in the production
process, not solely that the end product has novel DNA or protein.
MCA is looking at an "information alert labelling framework", which may create
incentives for producers to supply consumers with effective information about
genetic modification. The framework would require a standardised alert label be
placed on genetically modified products drawing consumer attention to the
attributes of the product.
The Ministry recognises that any requirement for producers to "alert label"
products must be balanced against compliance costs. Compliance costs in food
labelling are an important consideration for a food-exporting nation.
Ministry of Economic Development
The Ministry of Economic Development (MED) is charged with ensuring that the
policy decisions of government agencies are consistent with the Government's
goals of sustainable development.
The submission from the Ministry touched on matters relating to Warrant items
(c), risks and benefits, (d), international legal obligations, (e), liability issues, (f),
intellectual property issues, (h), global developments, (i), opportunities, (j) (iii),
main areas of public interest: economic matters, (k), strategic issues, (m), strategic
outcomes and (n), adequacy of statutory and regulatory processes. Issues raised
often spanned several Warrant items. Some of the points are summarised below.
Opportunities, economic matters and strategic outcomes
Genetic modification technology is already having an impact in sectors important
to New Zealand's economy and export markets. Land-based industries, including
forestry and wood products, are being affected and account for 11% of gross
domestic product and 70% of exports.
New Zealand has a reputation for high-quality research in agricultural and
horticultural industries. Research on genetically modified products is a potentially
valuable source of intellectual property for sale in world markets. It also could
enhance the export potential of New Zealand's agricultural products.
Opportunities for advancement from use of genetic modification include:
*
reduced production costs from biological controls and disease-resistant
genetically modified organisms
*
increased returns from faster growth rates and high-yielding crops
*
development of new raw materials and products.
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Risks from avoidance of genetic modification research and development include:
*
restricted industry development
*
loss of potentially valuable intellectual property
*
loss of research opportunities in New Zealand's areas of competitive
advantage.
Alternatively there are may be opportunities in focusing on non-genetic
modification or organic technology. The choice facing New Zealand could include
a spectrum of options, including genetically modified and non-genetically modified
products.
The Ministry notes that New Zealand has also been identified as having a
comparative advantage in "pharming" (using genetically modified animals to
produce pharmaceuticals) because of the absence of most major animal diseases.
Risks and benefits and strategic issues
Weighing risks and benefits will not necessarily lead to an "all or nothing" stance
on genetic modification. Uncertainties abound, particularly around reversibility,
environmental risk, the longer term preferences of key trading partners and the
extent to which it may be possible to maximise the use of both genetic modification
and non-genetic modification to maximise benefit to the New Zealand economy.
Considerations of the risks and benefits of use or non-use of genetic modification
may include the following factors.
Benefits of use:
*
increase in new intellectual capital
*
retention/attraction of personnel
*
attraction of foreign investment.
Risks of use:
*
unknown degree of reversibility of effects
*
inadequate safety procedures
*
environmental damage
*
cost of regulation
*
loss of competition
*
rejection of New Zealand products by genetically modified organism-averse
markets.
Risks of non-use:
*
limitation of innovation
*
limitation of value-added products New Zealand can trade.
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International legal obligations
Any decision on genetic modification has to factor in detailed specific legislation
and the complex range of international agreements already in place.
MED is responsible for the Trans-Tasman Mutual Recognition (TTMR) Act
1997. Section 10(1) states that goods sold legally in Australia may be sold in New
Zealand regardless of the different standards applying in each country. The mutual
recognition principle applies to genetically modified foods but not to foods that
contain a genetically modified organism.
Liability issues
Under the Consumer Guarantees Act 1993, goods must be of acceptable quality,
measured from the standpoint of a reasonable consumer fully aware of the state
and condition of the product, having regard to a range of factors such as the nature
of the product, information available and provided and all other relevant
circumstances. MED considers that Courts would be reluctant to deal with
acceptable quality issues regarding genetically modified organisms and genetically
modified products under this Act.
Limitation period difficulties under the Fair Trading Act 1986 should be rectified
by the current proposal in the Business Law Reform Bill for extension to three
years from discovery or reasonable discoverability.
Intellectual property issues
New Zealand has seven intellectual property rights statutes, two of which
(Copyright Act 1994 and Layout Designs Act 1994) provide rights automatically,
while the other five (Trade Marks Act 1953, Patents Act 1953, Designs Act 1953,
Plant Variety Rights Act 1987 and Geographical Indications Act 1994 (pending))
grant or extend protection by way of registration systems. The Patents Act is
currently under review.
On the international front, New Zealand is a member of, or party to, the
Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS
Agreement), International Union for the Protection of New Varieties of Plants
(UPOV) and World Intellectual Property Organization (WIPO).
MED considers that it is not appropriate to use intellectual property rights statutes
as mechanisms for regulating ownership of, or access to, New Zealand's genetic
resources. A distinction should be maintained between review of intellectual
property laws and the regulation of material or activities generally labelled
"intellectual property".
The submission noted that if plant material cannot be field-tested in New Zealand
before the grant of a plant variety right, then, even if the Plant Variety Rights
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Office were to issue a plant variety right using the results of field trials from
another country, the right to grow the variety in New Zealand cannot be exercised
in the absence of ERMA's consent for its release.
Treaty of Waitangi responsibilities
The Ministry noted particular Maori concerns with the review of New Zealand's
intellectual property rights statutes commenced in the early 1990s. Consultation
continues with Maori on the proposed recommendations.
Adequacy of statutory and regulatory processes
The submission notes that Regulatory Impact Statements, which must accompany
all Cabinet papers, are an important part of the quality of the regulation process
for new regulatory proposals. The Regulatory Impact Statement requirement was
to be reviewed by 31 March 2001.
MED stresses the importance of adequate checks and balances in the system to
ensure that regulations meet their objectives at the least cost to business.
Ministry of Foreign Affairs and Trade
The submission by the Ministry of Foreign Affairs and Trade was primarily related
to Warrant items (d) and (l): international obligations and implications. It provided
information on international agreements relevant to consideration of genetic
modification, including the Biosafety Protocol to the Convention on Biological
Diversity and the World Trade Organization (WTO) and its Agreement on
Technical Barriers to Trade (TBT Agreement) and Agreement on the Application
of Sanitary and Phytosanitary Measures (SPS Agreement). It also discussed
relevant agreements and arrangements under Closer Economic Relations (CER)
with Australia and made reference to international consideration of human rights
and bioethics of relevance to genetic modification.
Points made included the following observations on policy and international
interactions.
International obligations and implications
When governments consider policy responses to genetic modification, these
international agreements and arrangements must be taken into account. Rules in
these agreements require that measures affecting the trade of products, including
genetically modified products, are not arbitrary or indiscriminate, but rather are
based on objective scientific and technical approaches. Most of these rules are
generic, they are not technology specific, but their provisions are relevant to the
policy challenges of genetic modification.
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The international community has recently been discussing a number of specific
policy issues arising from biotechnology. Many countries are still in the early
stages of developing policy and regulatory responses to gene technology and there
is no consensus yet on whether international agreements need more explicitly to
incorporate genetic modification issues. The fluid nature of these issues means
that the impacts on New Zealand foreign and trade policy of different approaches
to gene technology are difficult to predict.
International bodies, of which New Zealand is a member, have been discussing
issues such as:
*
physical aspects of trade in biotechnology products, for example, trans-
boundary movements and environmental impacts
*
desirability of internationally agreed product and labelling standards
*
adequacy of existing risk management approaches
*
adequacy of existing international rules to deal with new technologies
*
incorporation of consumer concerns into decision-making processes.
These issues traverse both domestic and international policy responses to the
challenges of genetic modification, and their consideration at the international
level is still in progress.
At the time of the adoption of the Universal Declaration on the Human Genome
and Human Rights, New Zealand expressed concerns, especially that the
Declaration did not cover the ownership of human genetic material, and the lack
of time allowed for public, and particularly Maori, consultation. UNESCO's
1999 report on the implementation of the Declaration noted that New Zealand
already had in place legislative measures to protect individuals' rights under its
principles.
Countries have exhibited different attitudes to genetic modification, often based
on the presence or absence of significant export interests in genetically modified
crops and other products. The different approaches to labelling of genetically
modified food, either voluntary or mandatory, and the issue of consistency of such
schemes with the WTO's TBT Agreement are examples of the current absence of
a common approach.
The submission raised the possibility that discussion and information sharing on
genetic modification issues and challenges has the potential to enhance
international understanding.
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Ministry of Health
The extensive submission from the Ministry of Health (MOH) submission
addressed four main areas where genetic modification affects, or may affect, its
functions:
*
medical products and consumer issues
*
genetically modified foods in New Zealand
*
environmental health
*
Maori perspective of health and genetic modification.
Medical products and consumer issues
The Ministry has no position on genetic modification or genetically modified
organisms. MOH does recognise that medicines derived from genetic modification
are significant in the treatment of specific medical conditions. MOH believes that
gene technologies, including genetic testing, screening and gene therapies, will
begin to affect health care over the next five years with significant impact over the
next 10 to 20 years.
MOH points out that New Zealand is a tiny part (less than 0.1%) of the
international market for pharmaceuticals and has a strong interest in minimising
any barriers to pharmaceutical manufacturers entering the market with the latest
products. New Zealand and Australia are discussing the harmonisation of their
regulatory frameworks for medicines.
Currently MOH is undertaking analysis on the implications of genetic modification
for the range, costs, availability, benefits and risks in New Zealand's health system.
MOH identifies a number of consumer issues connected with genetic modification,
such as privacy of health information, ethical consideration of research and
treatment proposals, consumer information and protection of consumer rights.
MOH notes that currently there is no legal requirement to disclose the recombinant
origin of a medicine. MOH reports that it is common practice to voluntarily
provide genetic modification-related information and the MOH supports this
practice.
Genetically modified foods in New Zealand
Food regulation in New Zealand is currently in a transitional phase with the
introduction of a joint food code with Australia. There are mandatory standards
that must be complied with and Standard A18: Food Produced Using Gene Technology
regulates the sale and labelling of genetically modified foods. Only genetically
modified foods approved by ANZFSC may be sold and the labelling requirements
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have been extended to require all food that has any characteristics that have been
modified as a result of recombinant DNA techniques to be labelled.
MOH believes the amended A18 is a comprehensive, workable and enforceable
regime that will enhance consumer information and choice. Moreover, because it
is aligned with that of the European Union, it will ease difficulties of sourcing non-
genetically modified food and may lower trade barriers.
Environmental health
MOH has responsibility to identify and prevent harm from environmental risks to
public health under a number of statutes, such as the Biosecurity Act and HSNO
Act.
MOH notes that genetically modified organisms potentially could be both
beneficial and a threat to public health. (The example given was of using
genetically modified products to control exotic mosquitoes.)
Maori perspective of health and genetic modification
MOH recognises that genetic modification and related technologies raise
particular concerns about adverse impacts on whakapapa, mauri and
rangatiratanga. The collection and use of genetic material has the potential to
breach tikanga Maori, causing cultural and spiritual offence. It also raises some
complex issues around intellectual property rights. MOH also notes that
appropriate use of genetic modification could lead to environmental and health
benefits for Maori (as well as non-Maori). The submission gives the example of a
whanau's involvement in a genetic research project into an inherited cancer
affecting members over generations.
Te Puni Kokiri
The focus of the submission by Te Puni Kokiri (Ministry of Maori Development)
was on Warrant item (g), responsibilities under the Treaty of Waitangi, and the
implications under it in relation to genetic modification in New Zealand. It also
dealt with the concerns and interests held by Maori about genetic modification
(Warrant item (j), main areas of public interest) and identified five key strategic
issues (Warrant item (k)). The submission did not purport to speak for Maori as
a whole but to complement other government departments' submissions by
focusing on Treaty issues and Maori perspectives on genetic modification.
Issues raised are summarised below.
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Responsibilities under the Treaty of Waitangi
The Treaty partnership recognises the need for Maori to be involved in the design
of policies and practices affecting them. Treaty principles might assist in identifying
what the Crown's obligations under the Treaty of Waitangi are in regard to genetic
modification, genetically modified organisms, and products. This would include
the development of strategic options to enable New Zealand to address, now and
in the future, genetic modification, genetically modified organisms, and products.
There are three fundamental principles that underlie the mutual obligations of the
Treaty partners and from which more specific expressions of the Treaty principles
can be derived:
*
The Treaty partners are under a duty to act reasonably and in good faith in
their dealings with one another.
*
The Crown must make informed decisions by having proper regard to the
Treaty when exercising its discretion and powers.
*
The Crown has a duty to take positive action to redress past wrongs. This
duty includes active protection of Maori in the use of their resources.
The submission sets out in some detail the application of the Treaty principles to
government policy making as developed through court and Waitangi Tribunal
cases. This is discussed under:
*
good faith and partnership
*
consultation
*
obligation on Maori to act in good faith
*
active protection
*
right to development
*
tino rangatiratanga ("the mana to control resources in accordance with
custom")
*
taonga
*
need for compromise between Maori and the wider community.
Main areas of public interest: human health
The submission repeated comments made in an earlier submission to the
Ministry of Health.
Health for Maori people places emphasis on taha wairua (spiritual), taha whanau
(family), taha hinengaro (mental) and taha tinana (physical). This all-encompassing
perspective of health and wellbeing contrasts with the traditional western model in
which the physical aspects of health and sickness are emphasised. The labelling of
genetically modified food is one aspect of the much larger issue of Maori health
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and wellbeing, which is a link in the Maori belief system, an integral part of
Maori culture.
The continuing disparities in standards of health between Maori and non-Maori
highlight a strong need for Maori to be informed of the developments in the
health sector. In 1990, the death rate for Maori men and women from cancer and
heart disease was significantly higher than that of non-Maori. If genetically
modified foods have even a small likelihood of causing an adverse influence on
longer term Maori health, then this should be sufficient reason for ensuring that
adequate measures are taken to inform Maori consumers of the ingredients of the
foods they are eating. The choice to purchase rests with them. Without mandatory
labelling it becomes an issue of government policy decisions.
Main areas of public interest: environmental matters
The role of Maori as tangata whenua means that any environmental impacts of
genetic modification are of importance to them because it impacts on their links to
the land and its natural and physical resources.
Main areas of public interest: economic matters
The submission accepted that there were possible economic gains from genetic
modification but characterised them as supposition because the full impacts are
not yet known.
Main areas of public interest: cultural and ethical concerns
In July 1999 Te Puni Kokiri commissioned the International Research Institute
for Maori and Indigenous Education (IRI) at Auckland University to complete a
report on Maori perspectives on genetic engineering. The key issues that this
report identified as being important to Maori are:
*
need for further discussion and debate
*
incomplete knowledge of the risks of genetic engineering
*
cultural and intellectual property
*
links with other indigenous peoples
*
whakapapa (genealogy)
*
requirement for more information for Maori
*
perception of genetic engineering as being market driven
*
concerns for whenua (land)
*
role of globalisation
*
wairua (spirituality)
*
potential for food monopoly
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*
need for collective decision-making
*
mauri (life force)
*
tapu (sacred)
*
need for national body or Maori monitoring group.
Strategic issues
The submission raised five key strategic issues:
*
Education and consultation are vital to ensure that people have the proper
information to make informed decisions.
*
Risk management is a key consideration in determining the risks and
benefits of genetic modification.
*
Ethical and cultural opinions on genetic modification are just as valid as
scientific and economic assessments.
*
Intellectual and cultural property rights are a key consideration for Maori
in addressing genetic modification.
*
The Treaty of Waitangi is a reference point for Maori consideration of
these issues.