GE Free NZ in Food and Environment Incorporated v Environmental Risk Management Authority HC WN CIV 2007-485-1340

[2008] NZHC 2316

IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY

CIV 2007-485-1340

UNDER  The Hazardous Substances and New

Organisms Act 1996

BETWEEN  GE FREE NZ IN FOOD AND ENVIRONMENT INCORPORATED Appellant

ANDENVIRONMENTAL RISK MANAGEMENT AUTHORITY First Respondent

ANDNEW ZEALAND INSTITUTE FOR CROP AND RESEARCH LIMITED Second Respondent

ANDORGANICS AOTEAROA NEW ZEALAND SOCIETY INC; NEW ZEALAND BIOLOGICAL PRODUCERS AND CONSUMERS SOCIETY INC; BIO DYNAMIC FARMING AND GARDENING ASSOCIATION OF NEW ZEALAND INC

Section 128 Parties

Hearing:         31 March 2008 - 1 April 2008

Appearances: Mr Bennion and Ms Spurdle for Appellant

Mr Murray and Mr Allen for First Respondent
Ms Costigan for Second Respondent
Mr Broadmore for Section 128 Parties

Judgment:      12 May 2008         at 10.30 am

JUDGMENT OF MALLON J

Contents Introduction.......................................................................................................................................... [1] Statutory framework ............................................................................................................................ [6] ERMA’s decision............................................................................................................................... [24] Appeal jurisdiction............................................................................................................................. [27] Summary of submissions ................................................................................................................... [28] My view ............................................................................................................................................. [42] Result ................................................................................................................................................. [63]

GE FREE NZ IN FOOD AND ENVIRONMENT INCORPORATED V ENVIRONMENTAL RISK MANAGEMENT AUTHORITY AND ORS HC WN CIV 2007-485-1340  12 May 2008

Introduction

[1]      Crop and Food (the second respondent) are presently conducting a 10 year field trial of genetically modified broccoli, cabbage, cauliflower and forage kale plants (referred to as “GM brassicas”) on 0.4 hectares. The purpose of the trial is to assess the “agronomic performance” of the plants which have been modified for resistance to caterpillar pests.

[2]      The field trial is taking place pursuant to an approval granted by ERMA (the first respondent) under the Hazardous Substances and New Organisms Act 1996 (the Act).   ERMA granted approval to the trial because the benefits of the trial were viewed as outweighing the adverse effects of the GM brassicas and it was considered that the GM brassicas could be adequately contained.   Adverse effects were considered to be non-existent in light of the controls imposed on the trial.   Those controls were directed to preventing escape from containment.  They also provided for destruction at the end of the trial.  If funding is available Crop and Food proposes to test for adverse effects of the genetically modified plants in the course of the trial. But it is not certain that it will carry out such testing and ERMA’s approval of the trial does not require it to do so.

[3]      GE Free (the appellant) considers this trial is a “critical step along the way” to genetically modified broccoli, cabbage and cauliflower one day appearing in our gardens and on our dinner tables.  It contends that ERMA was in error in granting the approval because there is no requirement on Crop and Food to carry out adverse effects testing during the period of the trial.  GE Free says that trials that consider only some effects (ie. in this case the performance of the vegetables, in terms of growth rates, size and survival, and whether the vegetables will be resistant to pests) but do not consider other potential effects (ie. adverse effects on the environment if the genetically modified vegetables are released into the environment) are not “field tests” as defined by the Act and so cannot be approved by ERMA.

[4]      Parties  representing  the  interests  of  various  organic  growers  (the  s 128 parties) are concerned about the field trial because they wish to avoid any risk of contamination of organic produce which could affect growers’ organic certifications.

They support GE Free’s position that the field trial ought not to have been approved without any requirement to test for adverse effects.

[5]      The appeal raises a question of statutory interpretation under the Act.   In particular can a field trial, that will not necessarily carry out adverse effects testing, be approved by ERMA without requiring as a condition of approval that adverse effects testing be carried out.

Statutory framework

Purpose

[6]      The purpose of the Act is (s 4):

To protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms.

[7]      With that purpose in mind no “hazardous substance” may be imported or manufactured and no “new organism” may be “imported, developed, field tested, or released” except in accordance with an approval issued under the Act (s 25(1)).  A “new organism” includes a genetically modified organism (ss 24 and 2(1)).

Approvals

[8]      ERMA can grant approval to import any new organism into containment, to develop any new organism in containment, to field test any new organism in containment, to conditionally release from containment, to release from containment or to import for release (s 27).  “Containment” means “to restrict an organism… to a secure location or facility to prevent escape…” (s 2(1)). “Release” means to allow the organism to move within New Zealand (s (2)(1)).   In this case the application was to “field test” GM brassicas in containment.  “Release” of genetically modified broccoli, cabbage and cauliflower (which would mean that  genetically modified broccoli, cabbage and cauliflower could be grown and sold in New Zealand) could

not  occur  unless  and  until  a  separate  application  was  made  for  its  release  and approval given to it.

[9]      The ability to seek approvals at various  stages  (development,  field  tests, conditional release and release) is consistent with the Royal Commission on Genetic Modification (chapter 6, para 48).  There it is said that it may be necessary to extend research  beyond  laboratory  containment  to  understand  the  effects  of  the  new organism on the environment.  It is said that field tests enable research on effects in a “semi-contained” situation.   It is also said that the effects on the wider ecosystem may have to be studied in a wider controlled release situation.

[10]     The potential uncertainties as to the effects of new organisms that this staged process reflects, are also recognised by the requirement on ERMA “to take into account the need for caution in managing adverse effects” where there is uncertainty about these effects (s 7).

Field testing approval

[11]     A “field test” is defined as meaning (s 2(1)):

In relation to an organism, the carrying on of trials on the effects of the organism under conditions similar to those of the environment into which the organism is likely to be released, but from which the organism, or any heritable material arising from it, could be retrieved or destroyed at the end of the trials.

[12]     Every person intending “to field test any new organism in containment” must first apply for approval (s 40(1)).   An application for approval to field test a genetically modified organism must include (s 40(2)(b)):

(i)  the identification of the organism; and

(ii) the purposes of the field testing; and

(iii) the genetic modifications of the organism to be tested; and

(iv)the nature and method of field trials and the experimental procedures to be used; and

(v) all  the  possible  adverse  effects  of  the  organism  on  the environment.

[13]     ERMA is required to publicly notify an application for approval to field test a genetically modified organism (s 53(1)(d)).   Any person may make a written submission on the application (s 54).   ERMA can require the applicant to supply “further relevant information” (s 52(1)).  ERMA may commission a report or seek any advice from any person on any matters raised in relation to the application (s 58(1)).  There is provision for a hearing to be held (s 60).

[14]     Some applications may qualify for “rapid assessment” (ss 42, 42A and 42B). Otherwise, before ERMA can exercise its discretion to approve an application to field test a genetically modified organism in containment, it must be satisfied of three things (s 45):

a)       The application meets one of the specified purposes;

b)The beneficial effects of having the organism in containment outweigh the adverse effects of the organism; and

c)       The organism can be adequately contained.

[15]     As to the first of these criteria, a specified purpose includes “field testing” a new  organism  (s 39(1)(b)).    Accordingly,  providing  ERMA  is  satisfied  that  the application is for a “field test”, this first criteria is satisfied.

[16]     The second criteria requires ERMA to consider whether the benefits of the field test outweigh the adverse effects of the organism.  In considering this ERMA is required to take into account “all the effects of the organism”.  Specific matters that it must take into account include (ss 37, 44, 44A and 45)1:

a)        The ability of the organism to establish an undesirable self-sustaining population (s 37(a) and s 44(a));

1  These matters are found in a number of sections, some of which are not expressly linked to this second criteria in s 45, but for present purposes it is convenient to list them together.

b)The ease with which the organism could be eradicated if it established an undesirable self-sustaining population (s 37(b) and s44(a));

c)        The ability of the organism to escape from containment (s 44(b));

d)any adverse effects of field testing the organism on- i)           human health and safety; and

ii)the environment, in particular ecosystems and their constituent parts (s 44A(2)(a));

e)       any alternative method of achieving the research objective that has fewer adverse effects on the matters referred to in para d) above than the field test (s 44A(2)(b));

f)        any effects resulting from the transfer of any genetic elements to other organisms in or around the site of the field test (s 44A(2)(c)).

g)        When considering the adverse effects of the organism (s 45(1)(a)(ii)

and s 45(4)):

i)        any adverse effects of having the organism in containment;

ii)the probability that the organism may escape when subject to the controls that would be imposed; and

iii)      the effects if the organism were to escape.

[17]     Relevant to the third criteria for approving a field test, that of whether the organism can be adequately contained (referred to at [14] a) above), are the controls that are to be imposed on the field test.   A “control” means “any obligations or restrictions imposed … for the purposes of controlling the adverse effects of that … organism on people or the environment” (s 2(1)).

Controls

[18]     Any approval given to an application to field test “must” include certain controls.   For field testing a genetically modified organism mandatory controls include  controls  which  are  concerned  with  the  removal  or  destruction  of  any heritable material (s 45A).   They also include the controls that are specified in Schedule 3  (s  45(2)(a)).    The  matters  in  Schedule  3  that  apply  to  field  testing genetically modified organisms are concerned with preventing or managing the effects of escape from the containment.  They cover:

a)       Various requirements to limit the likelihood of any accidental release of any organism or any viable genetic material;

b)Details of, and security requirements concerning, access to the facility to exclude unauthorised people from the facility;

c)       Monitoring requirements to establish the presence of other organisms, phytosanitary requirements and requirements to secure the facility and openings against likely unwanted organisms, to exclude other organisms from the facility and to control undesirable and unwanted organism within the facility;

d)Various requirements to prevent unintended release of the organism by experimenters working with the organism;

e)       Requirements to control the effects of any accidental release or escape of an organism;

f)        Inspection  and  monitoring  requirements  for  containment  facilities;

and

g)       Potentially, the qualifications required of the person responsible for implementing the controls imposed and the provision of the management plan.

[19]     An approval to field test a genetically modified organism “may” also include other controls to give effect to the purpose of the Act (ie. to prevent or manage the adverse effects of the new organism) (s 45(2)(b)).

Other approvals

[20]     Similar procedures and requirements to those that apply to applications to field test also apply to applications to import into containment any new organism or to develop any new organism in containment (ss 40, 43, 44, 44A, 45 and 45A).

[21]     Application  may be  made  for  a  conditional  release  approval  (s  38A(1)). Amongst other things the application must include “all the possible adverse effects of the organism on the environment” (s 38A(2)(e)).  A conditional release approval can  be  granted  if  the  organism  is  likely  to  meet  certain  prescribed  minimum standards, there is “sufficient information to assess the adverse effects of the organism” and the positive effects of the organism outweigh the adverse effects of the organism (s 38C(1)).

[22]     The minimum standards require ERMA to decline the application if the new organism is likely to cause any significant adverse effect of various kinds (s 36).  In considering whether the new organism is likely to meet the minimum standards ERMA must take into account the controls that will be imposed and their likely effectiveness in meeting their objectives, and the ease with which the organism could be recovered or eradicated if it formed a self-sustaining population (s 38C(3)).   In considering whether the positive effects outweigh the adverse effects of the organism ERMA is to consider all the effects of the organism, the ability of the organism to establish a self-sustaining population, the ease with which it could be recovered or eradicated if it established an undesirable self-sustaining population and all the controls that will be imposed (s 38C(2)).

[23]     Similar procedures and requirements to those that apply to conditional release approvals also apply to an application to import or release a new organism (ss 34, 36,

37 and 38).  Like a conditional release approval, the application must include various information  including  “all  the  possible  adverse  effects  of  the  organism  on  the

environment” (s 34).  The application must also meet the minimum standards, the positive effects of the organism must outweigh the adverse effects of the organism and ERMA can decline the application if “insufficient information is available to enable the Authority to assess the adverse effects of the organism” (s 38(1)).  Unlike a conditional release approval, however, the approval is granted without controls (s 38(2)).

ERMA’s decision

Procedural background

[24]     Crop and Food’s application was made on 30 October 2006.  It was publicly notified on 31 October 2006.  Underlining the importance of the issues involved and the interest in the application before ERMA, written submissions were received from

959 submitters.  The majority of these were opposed to the field test.

[25]     ERMA prepared an Evaluation and Review report.  It obtained expert advice from Associate Professor Putterill on the scientific robustness of the Evaluation and Review report, particularly as to the adequacy of the assessment and evaluation of the risks.  A public hearing was held between 11 and 13 April 2007.  At the hearing ERMA heard from various parties including the applicant and 42 of those who made written submissions.

ERMA’s decision

[26]     ERMA approved the application with controls.  In its summary of its decision it said:

2.    … The controls provide for the adequate containment of the organisms, and for the management of any risks.  In particular the controls provide for:

•The specification of the field test site (the field test containment facility), being a location in the region around Lincoln;

•The containment of the genetically modified organism and any heritable material from these organisms;

•The control and securing of the facility in regard to the entry and exit of people;

•       Limitation of the duration of the approval to ten years;

•       Disposal of brassica plant material;

•Removal of all brassicas from the field test site before flower bud opening (and thus pollen release) can occur;

•A prohibition on ingestion of the brassicas in any form, by people and animals; and

•Monitoring and inspections both during the field test and after its completion.

3.    In  considering  the  application,  all  identified  potentially  significant adverse effects (risks and costs) of the organism were assessed as negligible,  taking  into  account  containment  provisions  and  other controls required by this decision.

4.    Concerns raised by Mäori, and particular Te Runanga o Ngai Tahu, were considered to be ameliorated by the controls, including the control requiring specific annual reporting.

5.   The principal benefits were considered to be the enhancement of knowledge and understanding of agronomic practices associated with those brassicas genetically modified for Bt1 expression, and upskilling of staff and increased experience in working with gene technology in the field. These two benefits were assessed as non-negligible.

6.    The Committee approves this application in accordance with section 45 of the Act.   The Committee notes that since all risks and costs were negligible, taking into account the risk management measures imposed by the controls, clause 26 of the Methodology applies.  The Committee concluded that the benefits of the application outweigh the risks and costs.

1An  abbreviation  used  to  denote  plants  expressing  Cry  toxins  derived  from  Bacillus thuringienis.

Appeal jurisdiction

[27]     A decision of ERMA may be appealed to the High Court on a question of law (s 126).  GE Free, which was a party that made submissions to ERMA on Crop and Food’s application, filed this appeal.  GE Free contends that ERMA erred because it applied a wrong legal test to the meaning of “field test”.  On the filing of an appeal

any person who made submissions to ERMA may appear and be heard on the appeal (s 128).  The parties referred to as “the s 128 parties” appear in support of GE Free’s appeal.

Summary of submissions

GE Free’s submissions

[28]     GE Free’s submission is that a field test which does not include testing for adverse effects is not a “field test” at all.  GE Free refers to the definition of “field test” as being the carrying on of tests on the “effects” of the organism.  GE Free says that the definition does not permit the applicant to pick and choose the effects of the organism which are to be tested.  The definition requires that the “effects”, which may be positive or negative, are to be tested.  It says that this means that where an applicant does not propose to carry out adverse effects testing, ERMA must either require that adverse effects testing be carried out as a condition of approval, or the application must be declined because the trial is not a “field test” and is therefore not for a specified purpose.

[29]     In support of this submission GE Free makes a number of points.   First, it refers to the definition of “effect” in the Act (s 2(1)).  That definition says that an effect  includes  any potential,  probable,  positive,  adverse,  temporary,  permanent, past, present, future, acute or chronic effect, or any cumulative effect which arises over time or in a combination with other effects.  GE Free notes that this definition includes both positive and adverse effects.  GE Free notes that “effects” in the “field test” definition is not qualified in anyway.   GE Free submits that where the Act wants to be specific about adverse or beneficial or positive effects it is.

[30]     Next GE Free refers to the field test definition referring to “effects” in the plural.   It says that this suggests that all effects are to be tested.   It says that the definition does not say that the applicant can elect a particular kind of effect that it will test for.  The definition is tied to testing for effects.  If the applicant need not test

for  all  effects  then,  it  is  submitted,  the  definition  could  simply have  read  “the carrying on of trials of the organism”.

[31]     Next GE Free points to a field test being the carrying on of trials on the effects of the organism “under conditions similar to those of the environment into which the organism is likely to be released”.  It says that field trials under the Act are with a view to future release of the organism.  They are an important step along the way to release.   A field test is the only place where adverse effects can be tested before  conditional  or  full  release  and  the  only  stage  in  the  process  where  the applicant must specify the experimental procedures to be used (s 40(2)(b)(iv)).  It is said that the best source of new information about an organism and its effects on the environment is the field trial.  The potential check provided by the ability to reassess a field trial (ss 62 to 64) is lost.  Without good information about adverse effects the quality of any risk assessment is reduced in respect of any future field trial or any application for conditional or full release.  GE Free is concerned that there may be a temptation to find in favour of  release  if  the  field  trial  is  successful.    That  is, approval of the organism may gain momentum – along the lines of “we have been testing for 10 years and have not seen any adverse effects, therefore there are none”.

[32]     The Act is said to be overwhelmingly concerned with adverse effects since the purpose of the Act (s 4) refers only to adverse effects.  The uncertainty about the adverse effects is the reason why new organisms are subject to control.   This uncertainty is reinforced by the requirement for a precautionary approach (s 7 of the Act) and the requirements on ERMA to monitor and review the extent to which the Act reduces adverse effects on the environment and to promote awareness of adverse effects and the prevention of safe management of those effects (s 11).

[33]     It is said that testing for positive effects is not what requires the involvement of ERMA.  ERMA’s only concern with positive or beneficial effects is to consider whether  it  is  worth  taking  a  risk  with  a  new  organism  that  might  cause environmental damage.  Any trial involves some risk, it is not a cost free process and it takes place in “the New Zealand common”.   A 10 year trial that produces only information about the positive effects of these plants is of little value in terms of the aims and purposes of the Act.  It is the adverse effects that need testing.  GE Free

points to the Royal Commission on Genetic Modification (referred to above) as specifically referring to a field test being to enable research on soil ecology.  It says that agronomic performance has already been tested in development and other tests.

[34]     Given all of this, GE Free says that ERMA’s role is to consider the nature of the activity for which approval is sought.  It says that applications for field trials are more akin to clinical trials of a drug on patients.  The primary aim of a drug trial might be see how well a drug achieves its main aims, but testing and monitoring for possible side effects is intrinsic to any such trial.   Similarly, it is said that unless adverse effects testing is part of a field trial, the trial does not fulfil the purpose of a field trial and represents a needless and unjustified risk to the environment.

Submissions for s 128 parties

[35]     The s 128 parties contend that ERMA has mixed two separate requirements. The first requirement is that the Authority must assess whether the beneficial effects of the field test outweigh the adverse effects.  Separately it needs to be satisfied that the organism can be adequately contained.  The s 128 parties submit that ERMA has decided that because the organism can be adequately contained, there are no adverse effects.

[36]     The s 128 parties further say that the requirement on the applicant to identify “all” the possible adverse effects of the organism on the environment is a stringent test verging on the impossible.   But one way ERMA could be satisfied that all adverse effects are identified is to require ongoing testing and monitoring for those effects.  Unless it can be satisfied that all adverse effects are identified then it cannot be satisfied that the positive benefits of the field test outweigh the adverse effects.  In this case the submitters were concerned about the risk of adverse effects.  The s 128 parties submit that because there is uncertainty about the adverse effects, the power to impose a requirement to test for adverse effects needed to be exercised or the application needed to be declined.

ERMA’s submission

[37]     ERMA’s view2  is that it can require an applicant to monitor for adverse effects (under its discretionary power in s 45(2)(b)), but it is not obliged to require this  because  it  is  not  one  of  the  mandatory  controls  provided  in  s  45(2)(a). Consistent with this, ERMA’s policy is toward “strong encouragement” rather than making this  a requirement  of  the  field  trial.    It  submits  that  GE Free  needs  to persuade the Court that ERMA was required to impose an obligation on Crop and Food to carry out adverse effects  testing pursuant  to  its  discretionary power  to impose controls (under s 45(2)(b)).

[38]     ERMA submits that s 45 is concerned with considering adverse effects in relation to the field test.  This, it is said, is confirmed by s 44A which is concerned with the risk of adverse effects during field testing and s 45A which deals with the risk of adverse effects at the end of the field test.  ERMA submits that its role is to regulate new organisms, not to direct scientific research.  It submits that there is no reason why an applicant should not be permitted to carry out a field trial providing the potential adverse effects of the field test are adequately addressed.  It says that it is up to the applicant to decide how best to manage its research and to be aware of the requirements for conditional release and release applications.

[39]     It is said that it is not for ERMA to anticipate in an application for approval to field test and to impose obligations in respect of, the adverse effects that will need to be considered if an application for conditional or unconditional release is received. At these later stages ERMA can only grant approval if the positive effects of the organism outweigh its adverse effects.   It must decline the approval if there is insufficient information to enable ERMA to assess the adverse effects.

2 ERMA was represented by counsel on this appeal and full submissions were filed.  ERMA is to be served with any notice to appear and be heard on an appeal and is a party to the appeal.  There is a separate question as to whether a decision making body should make full submissions that advocate for the correctness of a decision: see, for example, TV Works Ltd v Du Fresne CIV 2007 485 2060 13

March 2003 at [29] and [30].   However no party took objection to the fact that submissions were advanced on behalf of ERMA and the submissions were of some assistance.

[40]     In response to the s 128 parties’ submissions ERMA also submits that it did not mix the requirements for approval.   It says that it considered all the adverse effects as it was required to do.  It was satisfied that the positive benefits of the field test outweighed the adverse effects.

Crop and Food’s submissions

[41]     Crop  and  Food  submits  that  GE Free’s  interpretation  of  a  “field  test”  is wrong.  It says that it is not for ERMA to determine what the purpose of the field test should be.  Crop and Food points to the introductory words of the definition section which provide that the definition is to apply “unless the context otherwise requires”. It  submits  that  the  requirement  on  ERMA  to  take  into  account  any  alternative method of achieving “the research objective” indicates that a field test can have a particular research objective.  It submits that the definition of field test is to assist ERMA in deciding whether a particular application is an application to develop or to field test.  It notes that, while ERMA has not required that it do so, its intention is to carry out adverse effects testing.  It intends to do so because it is in its interest to gather as much information as possible on the field test.

My view

[42]     It is not in dispute that the controls that ERMA is required to impose do not specifically include any requirement to test for adverse effects during the field test (refer [18] above).   ERMA imposed the controls it was specifically required to impose, namely those specified in Schedule 3 and those relating to removal and destruction at the end of the test (s 45A(2)(a)).  ERMA also imposed some additional controls to give effect to the purpose of the Act.  Those additional controls did not include any requirement to test for adverse effects on the environment.

[43]     For ERMA to have made an error of law, either:

a)        GE Free’s submission that this was not a field test at all has to be accepted; or

b)It is necessary to accept the s 128 parties’ submission that in this case controls which required adverse  effects testing to take place were necessary to give effect to the purpose of the Act.

Field test

[44]     I am not persuaded by GE Free’s submissions that, having regard to the policy of the Act, a field test must include testing for adverse effects.  I agree that the Act  is  concerned  with  preventing  or  managing  adverse  effects,  that  ERMA’s functions are directed to that purpose and that, because of the uncertainty involved with hazardous substances and new organisms, ERMA is required to take a precautionary approach to managing adverse effects.  That, however, does not mean that ERMA can only approve field tests that include testing for adverse effects.

[45]     I accept that a field test may be an important step along the way to potential release.  I also accept that if an approved field test does not include a requirement to test for adverse effects then the potential opportunity to reassess the approval in light of information obtained from the testing is lost.  However, the statute sets out what ERMA must be satisfied about before approval can be given at any particular stage.

[46]     At the field test stage, providing ERMA is satisfied that the potential benefits of the test outweigh the adverse effects of the organism and that adverse effects from the trial are prevented or managed, and providing ERMA has taken a precautionary approach to managing the risks, ERMA has fulfilled the purpose of the Act.   The opportunity to reassess the field trial on the basis of information obtained during the test is lost.   But in granting the approval ERMA has already assessed that  the organism can be adequately contained and that the benefits of the test outweigh its adverse effects (and in this case the adverse risks were assessed as negligible).

[47]     At  the  conditional  release  or  release  stage,  an  application  will  only  be approved if the criteria for its approval are met.  An applicant which has not taken the opportunity to maximise the information obtained from a field test takes the risk that  there  will  be  insufficient  information  for  any  later  conditional  release application.  It cannot be assumed that ERMA will not act in accordance with the

statutory requirements when considering applications for conditional release or release.  If there is insufficient information about the adverse effects of the organism then the application will be declined.

[48]     This is the way that ERMA approached its assessment of the field test.  For example, ERMA noted that many submitters had expressed concerns that GM brassicas could potentially be toxic to humans if eaten.   One of the  controls it imposed was that none of the crops grown on the test site could be consumed by any person or fed to animals.  This was considered to address the submitters’ concern on this point in so far as it was relevant to a field test application.  ERMA also noted that a further application for a release approval would be necessary before effects on food safety and food choice would arise.

[49]     The Royal Commission of Genetic Modification refers to testing effects on the environment.   But that does not mean that every field test must test for all possible effects on the environment before it can be approved.   The applicant proposes what testing it wishes to carry out.   The applicant may discuss that with ERMA in advance of finalising the application but in the end the application put forward is the applicant’s.  ERMA is then required to apply the statutory criteria to the application presented to it.   That criteria strikes a balance between potential benefits from research (which research may need to extend into the environment to meet the research objective) and the adverse effects of the organism.

[50]     I therefore disagree that the purpose of the Act requires the interpretation of “field test” that GE Free proposes (ie. that it is a field test only if adverse effects are to be tested).  Turning to the words of the definition, it might have been more clear if the definition had said “the carrying on of trials on one or more of the effects of the organism”.   On the other hand the definition does not say that a field test is one which is carried on to trial “all of the effects” either.  I do not think that GE Free’s submission that the definition could have referred to “trials” would necessarily have made any difference, because it may still have been submitted that a trial that does not test for adverse effects is not a trial at all.

[51]     I  consider  that  the  definition  of  field  test  refers  to  “effects”  because  an applicant may wish to field test any of the particular kinds of effect (which might be a positive or negative effect) that an organism may have.  That is consistent with the need to set out in the application the purposes of the research and that the trial may have a particular research objective (refer [12] and [16] e) above).  In this case, Crop and Food is trialling the agronomic performance of the GM brassicas.  That is a type of effect that is within the definition.  If an applicant chooses to apply for approval for a field test that will not necessarily test for adverse effects that may well be relevant  to  whether  ERMA  approves  the test  (see  below)  and  it  might  also  be relevant later when considering whether there is sufficient information to approve an application  for  conditional  release  or  release.    But  it  is  not  an  absolute  bar  to obtaining approval on the grounds that it does not qualify as a field test.

Imposing a requirement to test for adverse effects

[52]     I do not accept the s 128 parties’ submission that ERMA applied the wrong test by mixing the requirements.  The requirement that the benefits of the organism in containment must outweigh the adverse effects is separate from the requirement that the organism can be adequately contained.   But that does not mean that the controls imposed to ensure containment are not relevant to whether the benefits outweigh the adverse effects.

[53]     That there is some overlap in the criteria is apparent from the requirement, when considering whether the beneficial effects outweigh the adverse effects, to take into account the probability that the organism will escape “after considering all the controls to which the organism would be subject if the application were approved” (ss 45(1)(ii) and (4)(b)).  Conceivably, however, ERMA might be satisfied that an organism can be “adequately contained” and that the risk of escape is very low, but the adverse effects if it were to escape were so great that the beneficial effects of having the organism in containment do not outweigh the adverse effects.

[54]     In this case ERMA identified the potentially significant adverse effects in the following  areas  of  impact:  the  environment,  human  health  and  safety,  the relationship of Mäori to the environment, Treaty of Waitangi principles, society and

community and market economy.  Each of the identified risks were considered to be negligible either because it was highly improbable that they would occur at all or because of the containment controls.   For example, concerns were raised by submitters that gene flow from GM brassicas to organic brassicas could occur and thereby cause economic loss to effected growers.  ERMA considered that this could occur through pollen  escape.    However  the  controls  imposed  meant  that  pollen escape was “highly improbable”.   That assessment was relevant when considering whether the beneficial effects of containment outweighed the adverse effects.  This meant that the economic loss was not a potentially significant adverse effect and was not considered further.

[55]     ERMA also identified the various risks of escape from containment and the controls to address the risks concluding in each case either that the risk was “highly improbable” or that the containment measures meant that the risk of escape was “highly improbable”.  It was satisfied that the GM brassicas and any heritable GM brassica material would be adequately contained.   It  also concluded that it was improbable  that  a  self-sustaining  population  would  be  established  even  if  GM brassica plants were to escape.  It considered whether there were alternative methods of achieving the research objectives with fewer adverse effects (s 44A(2)(b)).   It concluded that the adverse effects were sufficiently low so as not to be material in looking at alternatives.   Further, no  alternative methods for achieving the  same objectives had been identified.

[56]     ERMA  identified  two  beneficial  effects  as  being  potentially  significant. Those were:

a)        Enhancement of knowledge and understanding of agronomic practices for these GM brassicas; and

b)Upskilling of staff and increased experience in working with gene technology in the field.

[57]     These benefits were considered to be non-negligible.   These non-negligible benefits outweighed the costs of the application.  In reaching this conclusion ERMA had addressed each of the matters it was required to consider.

[58]     The next question is whether, because of the uncertainties about the risks, ERMA needed to require adverse effects testing in order to be sure that the beneficial effects of having the organism in containment outweighed the adverse effects and/or that the organism could be adequately contained.

[59]     If an applicant proposes to carry out adverse effects testing, then that testing may be a benefit that goes into the weighing process of whether the potential benefits outweigh the adverse effects.  If adverse testing will not, or may not, be carried out that may affect whether the benefits do outweigh the adverse effects.  As GE Free submits it might mean that it is not worth taking the risk with the new organism on the New Zealand common because the benefits are insufficient.  GE Free refers to an extreme case where a field trial might be approved for a genetically modified organism that has potentially enormous public benefits and unknown but potentially quite significant adverse effects, with no trade off for the risk the community has taken on if there is no requirement to test for adverse effects.   In that scenario however, given the need for a precautionary approach, if there were such uncertainty about the adverse effects in a particular case it is difficult to see how the test could be approved at all under the statutory criteria, or at least without a requirement to test for adverse effects throughout the test.

[60]     In this case ERMA said that it could not count as a benefit the potential for there to be some environmental impacts research due to the lack of information regarding funding for this research.  It also questioned whether it would be possible to obtain meaningful data on the environmental impacts.  Nevertheless, discounting this as a potential benefit, ERMA was satisfied that the potential benefits of the field test outweighed the adverse effects.  I consider that ERMA took the correct approach under the Act.   If ERMA was required to approve only applications that were of value in the sense of providing information about adverse effects, then I consider that the Act would have said so.

[61]     ERMA also acknowledged the risk that unanticipated effects may potentially occur.   Some of these risks were considered “highly improbable”.   In respect of another ERMA said that it considered that “one of the rationales for conducting field testing is to identify any unanticipated effects”.  It referred to Crop and Food’s stated intention  to  monitor  for  that  effect.    It  did  not  require  this  via  a  control,  but concluded   that   scientific   analysis   and   field   testing   “will   help   to   identify unanticipated   adverse   or   beneficial   effects”   of   the   GM   brassicas   and   that containment  controls  will  limit  the  degree  to  which  any  altered  plants  will  be exposed to the environment.

[62]     It  therefore  cannot  be  said  that  ERMA  did  not  consider  the  issue  of uncertainty.   It nevertheless reached the view that the beneficial effects of the organism in containment outweighed the adverse effects and that the organism could be adequately contained.   For this Court to interfere with that assessment would involve the Court reviewing the merits of the assessment, rather than determining a question of law.   The same is true of GE Free’s submission to the effect that the benefits of assessing agronomic performance only was low because a number of prior trials had already taken place.

Result

[63]     I consider ERMA’s approach was correct.  It is for the applicant to propose what it intends to do and how it intends to do that.  Providing the trial is testing for one or more effect under conditions similar to those of the environment into which it is likely to be released, then it is a field test.   ERMA’s role on an application to approve a field test is to consider whether that should be permitted in light of the benefits assessed against the risks and providing the organism can be adequately contained.  If those requirements are met, ERMA can approve the application.

[64]     In some cases those requirements may not be met because the applicant has not committed to carrying out adverse effects testing.   But in other cases, even without that, the beneficial effects may outweigh the adverse effects.  ERMA is not required to decline the application because there might be greater benefits if some other field trial (where all the effects, including adverse effects, are tested) could be

carried out. As ERMA says “consideration of alternative uses of resources is primarily the domain of the applicant” and its role is not “to influence funding allocation decisions either by the applicant or by external funding sources through decisions on applications”.

[65]     The appeal is dismissed.   If the parties are unable to agree costs they may submit memoranda within 30 days of the date of this judgment.

Mallon J

Solicitors:

T Bennion, Bennion Law, PO Box 25-433, Panama Street, Wellington ([email protected])

A Allen, ERMA New Zealand, PO Box 131, Wellington ([email protected])

J Costigan, Chapman Tripp Sheffield Young, PO Box 2510, Christchurch ([email protected]) D Broadmore, McBride Davenport James, PO Box 19001, Wellington ([email protected])