Inquiry into the alleged accidental release of genetically engineered sweet corn plants in 2000 and

252 Pages·2004·2.08 MB·English

I.9A
Inquiry into the alleged
accidental release of
genetically engineered sweet
corn plants in 2000 and the
subsequent actions taken

Report of the Local Government and
Environment Committee

Forty-seventh Parliament
(Jeanette Fitzsimons, Chairperson)
October 2004

Presented to the House of Representatives
I.9A INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN
Contents
Terms of reference 4
Introduction 5
Recommendations 7
Membership of the Committee 9
Definition of terms 10
Key individuals referred to in this report 13
1 Background 16
Novartis sweet corn seed Lot NC9114 16
Relevant legislation 17
Border security for seed imports 18
2 Sequence of events 20
First advice of possible contamination 20
Response by officials, consideration and decision making 21
Communications with Cabinet 37
Public communications 39
ERMA Board concerns 43
Informing the Royal Commission on Genetic Modification 45
3 Role of Government and its agencies 47
Ministry of Agriculture and Forestry (and the Biosecurity Act) 47
Environmental Risk Management Authority (and the HSNO Act) 49
Ministry for the Environment 52
Department of the Prime Minister and Cabinet 54
The role of the private sector 56
The role of Ministers and Cabinet 57
4 How is GM seed detected? 59
Introduction 59
Genes and DNA 59
Recombinant genes 60
Transgenic/GM plants and their seeds 61
Detection of recombinant gene sequences in GM seeds 63
Limitations of the PCR-based GM seed detection methods 65
Summary 69
5 Testing for genetic modification in Lot NC9114 72
The sampling scheme 72
PCR test results 74
Independent assessment of the PCR procedures, test results and their evaluation 78
Missing samples (L and M) 97
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INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN I.9A
Uncompleted tests and undisclosed information 98
Was a GM contamination tolerance level set and, if so, was it applied to Lot NC9114? 100
6 A biosecurity system for seeds imported into New Zealand 102
Development of a GM protocol for sweet corn seeds 102
GM protocols for maize, soybean, and oilseed rape seeds 105
Later incidents and evolution of compliance arrangements 107
International developments in GM management for seeds 109
7 Conclusions 114
Unanimous Committee Conclusions 114
Conclusions: New Zealand National, New Zealand First, Green Party and
ACT New Zealand Members (six members) 115
Conclusions: New Zealand Labour and United Future Members (six members) 121
Appendices
A Timeline of events 125
B Background information 144
C Current seed testing protocol 157
D Seed testing protocol as at 1 August 2001 163
E Scientific advice received by the Committee on PCR and the Lot NC9114
test results – Dr Jack Heinemann 171
F Scientific advice received by the Committee on PCR and the Lot NC9114
test results – Dr David Saul 189
G MAF application of the seed testing protocols 216
H Bibliography 223

List of Figures and Tables
Figures
4.1 The replication of DNA 60
4.2 Formation of recombinant gene 61
4.3 Introduction of a recombinant gene into a plant variety 62
4.4 Integration of a recombinant gene into a plant genome 64
4.5 Position of primers for the PCR detection of inserted recombinant genes 65
5.1 Outline of sampling that was carried out for PCR analysis on the New Zealand
consignments of Lot NC9114 73
Tables
4.1 Analysis of the 35S promoter in maize samples 68
5.1 Summary of PCR test results from the New Zealand consignments of Jubilee
sweet corn seed Lot NC9114 imported September–October 2000 76

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I.9A INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN
Terms of reference
Local Government and Environment Committee
Inquiry into the alleged accidental release of genetically engineered sweet corn plants
in 2000 and the subsequent actions taken
That the Committee inquire into the facts of the alleged accidental release of genetically-
engineered sweet corn plants in 2000, and of the decision making processes and the roles
of and actions taken by the Government, government agencies and relevant companies,
including inquiring into:
1 the extent to which biosecurity measures past and present control the risk of GM
contamination for imports of sweet corn, and how these controls compare to those of our
major trading partners
2 the scientific evidence on the likelihood of contamination of the Novartis Lot
NC9114 and the adequacy of the testing undertaken at that time
3 what processes did government departments and agencies follow on being advised of
the suspected contamination
4 the scientific evidence relied on during decision making concerning the Novartis Lot
NC9114 seeds
5 whether a contamination tolerance level was accepted by Government in 2000 and, if
so, what part it played in decision making over the Novartis Lot NC9114 seeds
6 whether the public, other interested parties, Cabinet and the Royal Commission on
Genetic Modification were adequately informed about the issue at the appropriate time
7 the role of the relevant private companies in addressing the issue, including the
usefulness of information they provided, and any influence that they may have had on
decision making or communication of the issue
8 the compliance with the Hazardous Substances and New Organisms Act and
relevant regulations
9 recommendations.
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INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN I.9A
Introduction
In October 2002 the Local Government and Environment Committee began an inquiry
into allegations that corn, contaminated with genetically modified seed, was planted in
2000. The inquiry was instigated as a result of controversy that occurred during the 2002
general election campaign created by the publication of the book Seeds of Distrust by Nicky
Hager. The terms of reference for the inquiry were focused on establishing the facts of
what occurred and the appropriateness of the responses by public authorities.
Setting the parameters
As we deliberately made the terms of reference quite specific to this incident, we did not
invite general submissions about the subject. We did seek information from people with
first-hand information about, or personal involvement in, both the events surrounding the
import, testing or planting of the corn, and the decision-making process that followed.
Specialist adviser
Recognising that this inquiry would involve consideration of complex, factual scientific and
statistical matters, we engaged a specialist adviser Dr Michael Taylor, Manager Biosecurity,
Cawthron Institute, Nelson. Dr Taylor has a broad background in the biological sciences
and a research interest in risk management. He has been a member of various national and
international biosecurity review panels. Importantly, his advice was independent of any
vested interest, for or against, genetic modification.
We appreciate the support of Cawthron Institute which enabled Dr Taylor to be available
to us. The following colleagues from the Cawthron Institute who assisted him are also
acknowledged: Eykolina de Zwart, Research Scientist; Dr Andrew Fidler, Research
Scientist; and Daphne Willis, Librarian.
Conduct of the inquiry
We received submissions from GE Free New Zealand, Syngenta Seeds Pty Ltd, New
Zealand Institute for Crop & Food Research Limited and Nicky Hager of Wellington.
Written replies to our questions were received from Prime Minister Rt Hon Helen Clark,
Hon Pete Hodgson, Hon Jim Sutton, Hon Marian Hobbs, the Ministry for the
Environment, the Environmental Risk Management Authority, the Ministry of Agriculture
and Forestry, and the Department of the Prime Minister and Cabinet.
In August 2003 we heard oral evidence from: Hon Marian Hobbs; Mark Prebble and Ruth
Wilkie from the Department of the Prime Minister and Cabinet; Dr Bas Walker and Dr
Donald Hannah from the Environmental Risk Management Authority; Barry O’Neil,
Richard Ivess and Larry Fergusson from the Ministry of Agriculture and Forestry; Barry
Carbon and Marilyn Bramley from the Ministry for the Environment; Denise Church
(former chief executive of the Ministry for the Environment); Peter Gerner, Gordon Day
and Willy de Greef from Syngenta Seeds Pty Ltd; Dr Russell Poulter; and Allan Hardacre.
During the course of our consideration of this inquiry we sought written evidence on
specific difficult technical matters from two expert witnesses, Dr Jack Heinemann and Dr
David Saul. Dr Heinemann, a molecular geneticist, is Associate Professor, School of
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I.9A INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN
Biological Sciences, University of Canterbury, Christchurch and Founding Director of the
New Zealand Institute of Gene Ecology at the University of Canterbury. Dr David Saul,
also a molecular geneticist, holds the position of Senior Lecturer, Microbiology and
Biotechnology, School of Biological Sciences, University of Auckland, Auckland. We
recognise that we were very fortunate to have their expert assistance with those very
difficult matters and we take this opportunity to publicly thank Dr Saul and Dr Heinemann
for their contribution to this inquiry.
Structure of the report
Recognising that many people will read this report in sections, we have repeated
information where we think it will aid a reader wishing to focus on a particular section.
This report begins with a background to the event in Chapter 1, a timeline in Chapter 2,
and then an explanation of the roles of Government and its agencies that were involved in
Chapter 3. Chapter 4 explains the science involved in testing for GM and Chapter 5
outlines how the seed lot in question was tested. Chapter 6 discusses biosecurity
arrangements within New Zealand and overseas.
Our conclusions about what happened are in Chapter 7. Our recommendations for the
future have been brought together at the front of the report to assist the reader.
References to the Bibliography (Appendix H) appear in square parenthesis throughout the
report.
In conclusion
Although the Committee reached different conclusions about some aspects of what
happened at the time, our recommendations on arrangements for the future are largely
agreed.
We hope that our intensive investigation of this incident will help point the way to systems
that will prevent such confusion recurring and provide clarity for officials charged with
implementing the law, and certainty for industry and the public.

Jeanette Fitzsimons
Chairperson
Local Government and Environment Committee

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INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN I.9A
Recommendations
From our inquiry, the Local Government and Environment Committee makes the
following recommendations to the Government.
1 When new legislation is passed or new risks arise, relevant government agencies
should analyse all the foreseeable types of compliance breaches that could occur and
ensure they have operational protocols and clear responsibilities to cover all of them
prior to an event. Even now, in the context of GE biosecurity, MAF, ERMA and
MfE should ensure that, among them, they review whether they have adequate plans
for all foreseeable risks and agreement on the meaning of key terms. Cooperative
relationships between agencies are necessary for these sorts of inter-agency response
systems to work in practice.
2 MAF and ERMA should ensure they have best-practice systems to manage:
a. Technical biosecurity risk (that is, scientific risk assessment).
b. The risk to the reputations of MAF and ERMA, which could be undermined if
the public does not have confidence in their management systems.
c. The commercial trade risks to the integrity of the New Zealand brand.
3 Where possible, plans for responding to incidents should include timeframes and
deadlines for decisions scheduled in advance (for example, with respect to the
expected flowering times of crops). This would give increased certainty to industry,
and other stakeholders.
4 A formal process should be established to ensure that the commercialisation of new
GM varieties overseas is regularly reviewed and protocols developed for mandatory
testing of seeds of the same species imported into New Zealand.
5 Where officials decide to consult about rules or protocols for the implementation of
laws, that consultation should include a balanced range of stakeholders. It is not
appropriate to consult with stakeholders when making decisions about how to apply
the law in an individual case.
6 Government regulators must have access to all laboratory data if they require it – the
testing results, related laboratory records, and key details of testing procedures.
Regulators should be able to communicate directly with laboratories without
hindrance from confidentiality obligations or contractual terms between the
laboratory and the company. These need to be a written requirement of the protocol.
All our scientific advisers strongly recommended this change.
7 Importers must not be able to report tests selectively. They should be required to
give an assurance that any adverse tests have been disclosed.
8 Government agencies should identify appropriate experts (for example,
internationally recognised molecular geneticists from New Zealand or overseas) and
set up systems for obtaining advice from them when required, such as in the
development of protocols and standards, the independent review of risk
management systems, and in the management of unforeseen incidents.
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I.9A INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN
9 Government officials should keep proper records of meetings, phone calls and
actions taken, such as the collection of field samples. Only a reliable record of what
occurred can help improve systems for the future.
10 New Zealand rejects any seed found at the border that contains any GM seed (no
matter how low the level). We recommend that where the test protocol is passed (that is,
no GM is found and the tests give 95 percent confidence that 0.1 percent or more GM
content would have been found), and the seed has been planted, then those crops (but not
unused seed) should be able to be grown, harvested, and consumed. This should apply only
where the contamination is from GM varieties approved for consumption by New Zealand
or comparable overseas jurisdictions, and not from varieties engineered to produce
industrial chemicals or pharmaceuticals.
We have based recommendation 10 on the following reasoning:
• The protocol for testing imported seeds currently gives 95 percent confidence that
GM seed content of 0.1 percent or more (that is, one in 1,000 seeds) will be detected.
• Because of practical seed sampling constraints and the limits of sensitivity of test
apparatus, this is about as good a standard as can presently be tested to.
• Nevertheless, even if the protocol is met, there remains a 5 percent risk that 0.1
percent GM seed content will not be detected, and a greater than 5 percent risk that a
GM seed content of less than 0.1 percent might be missed. This means that low
levels of GM content may be found by later tests: on the same batch of seed, on the
crops grown from that seed, or on the food produced from the crops.
• A level of risk cannot be avoided by any testing protocol, except if each and every
seed were tested. This would be impractical and would destroy all of the seed.
• In our opinion, it is unfair that, having passed a stringent testing protocol, the seed
importers and growers remain at risk of being found in breach of the law if later tests
find low levels of GM in the seeds or crop.
• The importer and grower can do little more than they have done. Little is achieved
by leaving them at risk for something they cannot prevent.
• In other words, once seed has passed the testing protocol and has been approved for
importation that decision will not be reversed on the basis of subsequent tests,
except where it is shown that the test protocol was not properly followed, or for one
of the exceptions referred to above.
The Green and United Future members further recommend that any seed derived from
such a crop must not be allowed to be planted without being tested again according to the
protocol to remove the possibility of amplifying the contamination.
New Zealand National members believe also that a practical tolerance level of GM content
should be permitted for seed imports at the border and that the HSNO Act should be
amended to provide Cabinet with the power to regulate for a practical tolerance on a case-
by-case basis, with the emphasis being placed on the actual health and environmental risks.
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INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN I.9A
Membership of the Committee
Jeanette Fitzsimons (Chairperson)
David Parker (Deputy Chairperson) (from 27 March 2003)
David Cunliffe (Deputy Chairperson) (to 26 March 2003)
Shane Ardern (to 4 November 2003)
Larry Baldock
Hon Rick Barker (to 18 June 2003)
John Carter (to 10 April 2003)
Dr Ashraf Choudhary (from 26 March 2003)
Ann Hartley
Dave Hereora (from 3 March 2004)
Dr Paul Hutchison (from 10 April 2003)
Nanaia Mahuta
Hon Damien O’Connor (to 3 March 2004)
Jim Peters
Hon Dover Samuels (to 26 March 2003)
Hon Ken Shirley
Hon Clem Simich (from 4 November 2003)
Hon Dr Nick Smith
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I.9A INQUIRY INTO THE ALLEGED ACCIDENTAL RELEASE OF GENETICALLY ENGINEERED SWEET CORN
Definition of terms
APHIS Animal and Plant Health Inspection Service (United States)
CFR New Zealand Institute for Crop & Food Research Limited
DPMC Department of the Prime Minister and Cabinet
ERMA Environmental Risk Management Authority of New Zealand
EC European Commission
The group that embodies and upholds the general interest of the
European Union and is the driving force in the Union’s
institutional system.
ESR Institute of Environmental Science and Research Ltd
EU European Union
GE Genetic engineering/genetically engineered
GM Genetic modification/genetically modified
Note: The terms GM and GE both have the same meaning and
are used interchangeably throughout this report.
GMAC Genetic Manipulation Advisory Committee (Malaysia)
GMO Genetically modified organism
Defined in the HSNO Act 1996 as:
… any organism in which any of the genes or other genetic material
(a) have been modified by in vitro techniques; or
(b) 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.
Organisms that are produced by either intra- or inter-specific gene
transfer, and all offspring of these for an unlimited number of
generations, are included in the Hazardous Substances and New
Organisms Act 1996 definition. (ERMA 10A-1998)
HSNO Act Hazardous Substances and New Organisms Act 1996
Identity preservation Identity preservation is the process of maintaining the identity of
different crops. It involves separate storage, handling,
documentation and testing of the crop’s identity. It aims to capture
the extra value of a special crop by preventing mixture with crops
that do not contain that characteristic.
IHS Import Health Standard
ISO International Organisation for Standardisation
The source of ISO9000, ISO14000 and more than 14,000
International Standards for business, government and society.
ISTA International Seed Testing Association
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