Royal Commission On Genetic Modification

Royal Commission On Genetic Modification

A four-person Royal Commission headed by former Chief Justice, Sir Thomas Eichelbaum, will inquire into genetic modification

Hon Marian Hobbs
Minister for the Environment

17 April 2000

Royal Commission On Genetic Modification

A four-person Royal Commission headed by former Chief Justice, Sir Thomas Eichelbaum, will inquire into genetic modification, the Minister for the Environment, Marian Hobbs, announced today.

The other members of the Commission being recommended to the Governor General for appointment are:

• Dr Jean Fleming, Senior Lecturer, Department of
  Anatomy and Structural Biology, Otago Medical School. She is highly qualified in
  the field of Biochemistry, Physiology and Structural Biology.
• Rev Richard Randerson, of Auckland who has an
  extensive academic background in religious studies and brings a solid
  understanding of ethical issues to the Commission.
• Dr Jacqueline Allan, a GP of Auckland with
  considerable experience in the area of Maori medical health. She brings an
  understanding of both medical and Maori issues to the Commission.

A voluntary moratorium on all applications for the release of genetically
modified organisms will be negotiated between the government and relevant
industry and research groups. The moratorium will also apply to field testing of
GMOs but with some limited exemptions.

"I will seek assurances from the signatory to the moratorium that there will
be very strict controls places on the field test," Ms Hobbs said.

The moratorium will be in force for the length of the Commission's inquiry.

"Any decision to allow a general release of a GMO may be irreversible,"
Marian Hobbs said. " In order to keep our options open, we want to ensure that
there will be no GMOs released into the environment until the Royal Commission
has completed its report and the Government has considered its findings.

"The moratorium will mean that there will be no deliberate releases of GMOs
during the inquiry. We understand that research and industry groups are
generally comfortable with this approach. The Life Sciences Network, a research
and industry grouping, has offered its support for a moratorium on deliberate
releases of GMOs."

Marian Hobbs said the Government wants the inquiry to stimulate a
broad-ranging discussion on genetic modification. The Royal Commission's chief
objective is to inquire into and report on the strategic options available to
enable New Zealand to address genetic modification now and in the future.

It may also recommend any changes in the current legislative, regulatory,
policy or institutional arrangements for addressing genetic modification
technologies and products in New Zealand.

The cost of the Commission is estimated provisionally at $4.8 million. It
will have 12 months to report.

A Royal Commission, which has the ability to require evidence to be
presented, has the highest status and greatest perceived independence of all
forms of public inquiry, the Minister said.

"This will allow the public to have meaningful input into the inquiry while
providing for a prompt response on genetic modification issues, in a field of
research and development that is constantly expanding, " Marian Hobbs said. "The
Government wants the inquiry to be conducted as informally as practicable.

"The Commission will be required to consult widely and to adopt procedures
that encourage a diverse range of people and groups to participate in the
proceedings and present their views. This will enable the Commission to reach
sound and robust conclusions."

To meet the government's objectives the inquiry will address the following
principal areas:

Genetic Modification in General

• Where, how and for what purpose is genetic modification and its products
  being used in New Zealand at present;
• the evidence (including the scientific evidence) and the level of
  uncertainty about the present and possible future application of genetic
  modification techniques and use of genetically modified organisms and products
  in New Zealand;
• the risks and benefits from the use or avoidance of genetic modification
  technologies and products in New Zealand and how each of these is likely to be
  distributed;
• the international legal obligations New Zealand faces with regard to genetic
  modification;
• the current and future liability and intellectual property issues involved
  in the use of genetic modification in New Zealand;
• the Crown's responsibilities under the Treaty of Waitangi in relation to
  genetic modification;
• the global developments and issues that may influence how New Zealand is
  able to use or limit the use of genetic modification technologies;
• the opportunities that may be open to New Zealand from the use or avoidance
  of genetic modification technologies;

Areas of Public Interest:

human health (including biomedical, food safety/consumer choice);
• environmental (including biodiversity, biosecurity issues, and the health of
  ecosystems);
• economic (including research and innovation, business development, primary
  production, and exports);
• cultural and ethical concerns;

Other Key Issues:

• the key strategic issues drawing on ethical, cultural, environmental, social and economic risks and benefits arising from the use of genetic modification;
• the international (legal and policy) implications of any measures that New Zealand might take with regard to genetic modification, including the costs and risks associated with particular options;
• the range of strategic outcomes for the future application or avoidance of genetic modification techniques and the use of genetically modified organisms and products in New Zealand;
• whether the statutory and regulatory processes controlling the use of genetic modification technology and products in New Zealand are adequate to address the desired strategic outcomes and whether any legislative, regulatory, policy or other changes are needed to enable New Zealand to achieve these outcomes.

TERMS OF REFERENCE

Primary objective

The primary objective of the Royal Commission shall be to inquire into and report on the strategic options available to enable New Zealand to address genetic modification now and in the future.

The Royal Commission may also recommend any changes in the current legislative, regulatory, policy or institutional arrangements for addressing genetic modification technologies and products in New Zealand.

The Commission will receive representations on, inquire into and investigate the following matters:

• Where, how and for what purpose is genetic modification and its products being used in New Zealand at present;
• the evidence (including the scientific evidence) and the level of uncertainty about the present and possible future application of genetic modification techniques and use of genetically modified organisms and products in New Zealand;
• the risks and benefits from the use or avoidance of genetic modification technologies and products in New Zealand and how each of these is likely to be distributed;
• the international legal obligations New Zealand faces with regard to genetic modification;
• the current and future liability and intellectual property issues involved in the use of genetic modification in New Zealand;
• the Crown's responsibilities under the Treaty of Waitangi in relation to genetic modification;
• the global developments and issues that may influence how New Zealand is able to use or limit the use of genetic modification technologies;
• the opportunities that may be open to New Zealand from the use or avoidance of genetic modification technologies;
• the main areas of public interest in genetic modification including:
  • human health (including biomedical, food safety/consumer choice);
  • environmental (including biodiversity, biosecurity issues, and the health of
    ecosystems);
  • economic (including research and innovation, business development, primary
    production, and exports);
  • cultural and ethical concerns;

• the key strategic issues drawing on ethical, cultural, environmental, social
  and economic risks and benefits arising from the use of genetic modification;
• the international (legal and policy) implications of any measures that New
  Zealand might take with regard to genetic modification, including the costs and
  risks associated with particular options;
• the range of strategic outcomes for the future application or avoidance of
  genetic modification techniques and the use of genetically modified organisms
  and products in New Zealand;
• whether the statutory and regulatory processes controlling the use of
  genetic modification technology and products in New Zealand are adequate to
  address the desired strategic outcomes and whether any legislative, regulatory,
  policy or other changes are needed to enable New Zealand to achieve these
  outcomes.

Process

The Royal Commission will consult with the public in a way that
allows people to express clearly their views, including ethical, cultural,
environmental and scientific perspectives, on the choices regarding genetic
modification in New Zealand.

In order to do this the Royal Commission will consult widely during the
course of the inquiry and adopt procedures that will encourage people to
participate. This will include consulting and engaging with Maori in a manner
that specifically provides for their needs.

In addition to receiving representation from the public and interested
parties, the Royal Commission will utilise relevant expertise, including
consultancy and secretarial services and where appropriate conduct its own
research.

Definition

For the purposes of this inquiry 'genetically modified
organism' means any organism in which any of the genes or other genetic
material:

• have been modified by in vitro techniques; or
• are inherited or otherwise derived, through any number of replications, from
  any genes or other genetic material that has been modified by in vitro
  techniques.

In general terms genetic modification means the use of genetic engineering
techniques in the laboratory involving:

• the deletion, multiplication, modification or moving of genes within a
  living organism; or
• the transfer of genes from one organism to another; or
• the modification of existing genes or the construction of novel (new) genes
  and their incorporation in any organisms; and/or
• the utilisation of subsequent generations or offspring of genetically
  modified organisms.

The inquiry will not consider the generation of organisms or products using
modern standard breeding techniques (including cloning, mutagenesis, protoplast
fusions, controlled pollination, hybridisation, hybridomas and monoclonal
antibodies).

'Organism' includes human beings and 'product' covers all current and likely
future research, medicinal, commercial, chemical and food uses of the technology
in New Zealand.

Reporting Date

The Royal Commission will report to the Governor-General twelve
months from the signing of the Warrant.

PROPOSED VOLUNTARY MORATORIUM

The Cabinet has agreed that a voluntary
moratorium on all applications for release and (with limited exemptions) field
testing of genetically modified organisms be negotiated between the Government
and relevant industry and research groups.

Cabinet has directed the Ministry for the Environment to lead negotiations to
develop a voluntary agreement on behalf of the Government, with relevant
industry and research groups, and to report back within three months to the
Cabinet Finance, Infrastructure and Environment Committee on progress made and
the need for additional measures, including legislation.

In respect of field tests the following proposed process would form the basis
of negotiations to develop a voluntary moratorium.

• A participant in the voluntary moratorium prepares a draft application for a
  field test.
• The participant in the voluntary moratorium forwards the draft application
  to the Minister for the Environment.
• The Minister checks that the draft application meets one of the following
  criteria:
  1. involves fermentation of more than 10 litres of micro-organisms in
     conditions of highly secure containment
  2. field tests for medical purposes or for the development of therapeutic
     agents where these are necessary to continue an existing line of inquiry or to
     develop and test new drugs or potential therapies
  3. applications where the risk of the loss of scientific inquiry knowledge to
     New Zealand is substantial or where the potential health, environmental or
     commercial benefits to New Zealand would be lost if the application was delayed
     until after the Royal Commission
  4. applications where the level of investment in an ongoing line of inquiry is
     substantial and the inability to make an application for a field test would
     prejudice the value of earlier investment.

• If the draft application meets one or more of the above criteria, the
  Minister then checks that it specifies controls for the organism on which the
  test will be conducted, which meet the following requirements (relevant to the
  organism to be tested):
  1. Conditions placed on any field test involving genetically modified plants
     will ensure that:
     • once any reproductive structure above the ground reaches the stage where it
       is capable of releasing heritable material it shall be immediately removed, and
       transported in secure containment if required, and destroyed
     • any heritable material beneath the ground is retrieved, transported in
       secure containment if required, and destroyed once the test is complete unless
       the heritable material is required for research purposes in which case it shall
       be retained in conditions of high security.

  2. Conditions will be placed on any trial involving genetically modified
     animals containing human genes to ensure that all animals forming part of the
     test, including their offspring, are held in secure containment and also clearly
     identified in case of escape.
     • The Minister then advises the party to the voluntary moratorium on whether
       or not the draft application will be acceptable to proceed with. If the
       Minister's advice is not to proceed, an application for a field test approval
       under the Hazardous Substances and New Organisms (HSNO) Act would not be made.
       If the advice is that the draft application may proceed, the application is
       finalised and provided to the ERMA and the normal processes under the HSNO Act
       follow.
     • The Minister may at any stage ask the potential applicant, or other party,
       for further information to clarify matters relating to the draft application.

QUESTIONS AND ANSWERS

Q	Is 12 months long enough to consider the issue?
A:	Genetic modification research and development is a rapidly moving area. A 12-month period for the Royal Commission gives enough time for the public to have meaningful input into the inquiry and for the Commission to provide a prompt response to the Government on genetic modification issues. If the Royal Commission continues for longer than this, it may be overtaken by new developments in the technology.
Q:	Why have you opted for a voluntary moratorium - why not just legislate?
A:	We believe the science and industry sectors are keen to act responsibly on this matter. A voluntary moratorium means that their concerns, as well as the concerns of the public are being considered. If those involved in the work agree to a moratorium then this gives the best possible chance of it being adhered to. To legislate could take longer and thus delay the Royal Commission. And if the bill went to a select committee then the arguments that should be presented to the Royal Commission would go before the select committee.
Q:	How long do you expect the negotiations on the moratorium to take?
A:	We need to take the appropriate amount of time to discuss these with the parties that will be affected and reach agreement with them on the best way to move forward on this. I am expecting that with goodwill from the scientific community this can be done quickly. Officials are to report progress within three months, by mid-July at the very latest, hopefully by early June, when the RC begins its work but not its public hearings.
Q:	Is the Government, through this moratorium, putting a stop to all genetic modification work? How does this fit with the Government's stated support for the knowledge society?
A:	No. The Government is stopping all GE research which poses risks to the public and to the environment.
Q:	What field tests will still go ahead?
A:	Any field test that is already approved under the HSNO Act will be able to continue provided the strict controls placed on it are adhered to. The Government will be stepping up inspection of these field tests to make sure that the conditions imposed are complied with. A new application for a field test will proceed only if it meets the exemption criteria, i.e. if it was for medical purposes, or if the test provided very substantial benefits to New Zealand. These would include economic, health and environmental benefits. An example of a field test with a potential environmental benefit could include developing biological controls for possums or other serious pests to New Zealand. There will be strict controls on any field test so that all heritable materials are removed and any organisms involved are securely contained and properly disposed of at the end of the test.
Q:	What field tests will be stopped?
A:	The proposed moratorium is designed to preserve New Zealand's choices about the use of genetic modification technology pending the outcome of the Royal Commission. Signatories to the voluntary moratorium would not be able to proceed with field tests that provide only limited benefit to New Zealand. This would include tests that grow seed only for overseas use. Field tests would not be allowed if they posed a risk of release of reproductive materials.
Q:	Will the moratorium apply to existing field tests?
A:	No, field tests already approved and with appropriate controls imposed on them will continue. The Government will be stepping up inspection of these field tests to make sure that the conditions imposed are complied with.
Q:	The moratorium is too restrictive.
A:	The moratorium will limit some field tests. These are the tests that are of no particular benefit to New Zealand science. In addition the Government is seeking a greater level of assurance about the containment measures established for those tests that are occurring or likely to start during the Royal Commission inquiry period. We are not interfering with the HSNO evaluation process for applications for field tests. What we are doing is asking some researchers to delay some aspects of research until the Royal Commission has given its advice on the future use of genetic modification in New Zealand.
Q:	Why a Commission of 4 rather than 5 members?
A:	The size of the Commission is not a numbers game. We have selected four highly skilled individuals that have complementary areas of expertise to consider the issues in front of the Royal Commission. Having more members for the sake of it would be an expensive waste of taxpayers' money.
Q:	There are not enough scientists on the Commission.
A:	The science and medical community are well represented on the Commission. The members are there to hear and consider the evidence - not research the issues. I have no doubt that the interested parties will bring all the necessary information in front of the Commission. In addition the Royal Commission will have a highly skilled secretariat to service the inquiry throughout the 12-month period, and it can seek expert advice on any subject.
Q:	What have other countries done about these issues? How can we be sure that the risks that have been identified overseas won't apply to here?
A:	We are keeping in touch with international developments. The situation here is not the same as it is elsewhere so a lot of the information coming in from overseas is not applicable.
Q:	How can we be sure that the system put in place to manage the risks will work, that nothing will go wrong?
A:	I am confident that the controls imposed by the ERMA and the extra monitoring we are putting in place are as strict as possible.
Q:	What progress has been made on genetically modified food labelling?
A:	Australian and New Zealand Health Ministers have made a decision in principle to label all genetically modified foods. The details of the amended standard are being worked through and we expect a final decision on the shape of the labelling requirements to be made midyear.
Q:	What does the Royal Commission mean in terms of the Biosafety Protocol?
A:	The protocol will be open for signature next month but is unlikely to come into effect for some years because there is a need for a minimum number of countries to ratify it. Under the usual New Zealand constitutional practice, ratification does not occur until the domestic legislative framework is brought into line with the obligations contained in the protocol. Prior to ratification, the protocol will be tabled in Parliament in line with our treaty making practice.

MEMBERS

CHAIR

The Rt Hon Sir Thomas Eichelbaum is the chair of the
Royal Commission on Genetic Modification.

Sir Thomas has highest qualifications in judicial proceedings
and has been appointed to various judicial committees during his professional
life. He was appointed Chief Justice 1989 and resigned from the position in May
1999.

He was granted a GBE in 1989 and became a Privy Councillor in 1989.

He has proven skills as a chairman and will bring to the Commission a wealth
of experience in hearing procedures, evaluation of evidence, synthesis of
information and summary of findings.

Sir Thomas was born in Germany and emigrated with his parents to New Zealand
in 1938.

He worked as a barrister and solicitor from 1950 and was appointed Queens
Counsel in 1978. During his career Sir Thomas appeared regularly in a wide range
of litigation before the New Zealand courts and tribunals and served as counsel
in a number of Commissions of inquiry including the Lake Manapouri Commission in
1970, the Enquiry into Chiropractic in 1978 and the Marginal Lands Enquiry in
1981.

He was appointed a judge of the High Court in 1982, was a member of the rules
committee of the high Court from 1969 to 1980 and from 1983 to the present. He
has also taken part in a number of other committees looking at the workings of
the High Court and represented the New Zealand judiciary on the Australian
Institute of Judicial Administration from 1987 to 1988.

Sir Thomas is an honorary member of the American bar association, an honorary
bencher of Lincoln's Inn and an honorary member of the International Academy of
Trial Lawyers.

He has sat on a number of appeals in the Privy Council and was a member of
the Australian Council of Chief Justices.

He is married and has three sons.

MEMBER - Ethicist

The Rev Richard Randerson has an extensive academic
background in religious studies and was awarded a Doctor of Ministry in San
Francisco.

He has worked in Ministries overseas and in New Zealand. He was
Social Responsibility Commissioner for the Anglican Church between 1990 - 1994
and in 994 he was appointed Assistant Bishop (for Church in Society) in
Canberra.

In 1999 he chaired a Government Poverty Task Force in Canberra. His interest
during his professional life has been to promote an ethical base for public
policy with regard to socio-economic matters, industrial relations, corporate
responsibility, the role of women, the environment, Treaty of Waitangi
relationships and a multi-cultural society.

The Rev Randerson has worked as a parish minister in New Zealand, New York
and the UK, worked as the Director of the Auckland City and Province's
Industrial Mission from 1971 to 1978 and ran the Inner City Ministry of
Wellington's St Peter's church from 1978 to 1990.

He became the Anglican Church's social responsibility commissioner from 1990
to 1994 when he took up the position of Assistant Bishop responsible for Church
and Society in Canberra.

During his career The Rev Randerson has initiated seminars on consultative
work styles, established corporate structures which were sensitive to the needs
of Maori and Pacific Islands staff, led seminars for managers to develop codes
of social responsibility and worked on a bicultural education process for the
Anglican church which led to the development of a national bicultural
constitution for the Church.

He brings a solid understanding of ethical issues to the Commission.

MEMBER - Scientist

Dr Jean Fleming is highly qualified in the field of
Biochemistry, Physiology and Structural Biology.

Her research and publications are in the area of molecular
reproduction and endocrinology. She was an ANZAC Fellow in 1987 in the Genetic
Engineering Laboratory, Howard Florey Institute, Melbourne.

An underlying theme of her research is the investigation of the stability and
structure of various hormonal and growth factors.

She has also supervised research into the genetic and developmental
differences between male and female animals and why these difference have
evolved. This research included investigations into reproductive cycles and
systems.

Dr Fleming also has a strong interest in encouraging the involvement of women
in science, their approach to research and their support networks. She convened
the 1993 Women's suffrage Centennial Science Conference and participated in both
Women. Science and Our Future (1996) and Living Science (1999) conferences run
by the New Zealand Association for Women in Sciences.

She has an interest in feminist pedagogy and in particular whether women
bring a different approach to the teaching of reproductive biology and
endocrinology.

Dr Fleming served as president of the Otago Institute Inc a regional body of
the Royal Society of New Zealand and chaired the programme committee of the
Inaugural International Science Festival in Dunedin in 1998.

She brings a sound understanding of scientific method and principles to the
inquiry. Her familiarity with biological and genetic research and her
understanding of gene function will be of great assistance to the Commission.

MEMBER - Maori/Medical/Scientific/Technical

Dr Jaqueline Allan (Kati Mamoe ki Rakiura,
Kai Tahu) has considerable experience in the area of Maori health.

She has both secondary teaching and medical qualifications. Dr Allan served
on the Maori Workforce Development Committee (Dept of Health), the Maori Health
Advisory Committee to the Minister of Health, was part of the joint working
party into IPAs, and served on the Ministerial Advisory Committee on Genetic
Screening.

She co-founded and is a former medical director of Tipu Ora. She has also
served as the Director of South Health (IPA) Ltd.

Dr Allan was involved with the Women's Health League and was a founding
member of Te Ohu Rata o Aotearoa/Maori Medical Practitioners Association.

He hobbies are fly fishing and reading.

Dr Allan brings an understanding of both medical and Maori issues to the
Commission.