28/10/08
Submission from GE Free NZ (in food and environment)
Application Title: Application by: AgResearch Ltd, Ruakura Research Centre,
Private Bag 3115, Hamilton.
Application GMC07012 to import live animals, sperm, embryos, human and monkey cell-lines, to develop GE animals;
Application GMD08012 for indoor development; research, breeding and production;
Application GMD07074 development in outdoor containment production
Application GMF07001 for field tests for commercial production, around the country;
Contacts: C. Bleakley - 0273486731
J Carapiet 0210507681
This submission asks for the application to be declined before hearing.
We would like to be heard in support of this submission.
GE Free NZ in Food and Environment Inc:
1.1 GE Free NZ in Food and Environment is an Incorporated Society. It is a non-political voluntary community organisation providing information to its member and the public on issues concerning genetic modification. It also participates in forums working on committees and with government bodies.
1.2 This year it attended the forums as an observer at the COP /MOP UN Biodiversity and Cartegena meetings in Bonn.
1.3 It has regularly made submissions on ERMA publicly notified applications on behalf of its members.
1.4 On receipt of the application we sought further information the reply did not provide the information needed for us to make a submission. In September we sought a formal Reassessment of the application on a form 6 to look at the missing information and this too was turned down.
The Applications
2.0 This suite of applications (GMC 07012, GMD 08012, GMD07074, GMF07001) are high risk to New Zealand’s environment and economy.
2.1 They cause immeasurable offence across cultures, ethnicities and all religions.
2.2 The potential for risk is un-assessable.
2.3 Published studies into the efficacy of the milks, the fate of the failed trials on the milks, the effects on animal health, the unknown effects on the environment and human health are not given to submitters to comment on.
2.4 There is insufficient data on the effects on the surrogate mothers and placental leakage causing microchimerism, the failure of viable genetic lines through foetal abnormalities like abnormal placentation, hydrops syndrome, limb and vertebrae structural deformities so submitters cannot make informed decisions.
2.5 The vector sequences using lentiviruses and HIV proteins cannot be accepted until it is known how and where they will be used.
2.6 The use of Human DNA is highly offensive and there has been no public consultation as to the nature of the origins of these genes or their effects once engineered.
2.7 ERMA expert staff should have sought this information before notification so as to be able to give submitters sufficient information for them to comment on.
2.8 In previous publicly notified trials to ERMA, submitters have provided scientific data that show the potential of such applications to seriously damage our economy and environment (see submissions on previous applications GMD02028, and GMF98009).
2.9 GE Free NZ have previously identified large gaps and missing or insufficient information in applications that the Applicant has not addressed in the application Form 4 for field trials.
2.10 Consequently, this has been over looked or in some cases dismissed by ERMA in the Evaluation and Review reports that assess each application and submissions and at the public hearings.
2.11 In this context it is noted the Authority has never turned down an application once notified and never enforced controls on the testing of adverse effects that need to be carried out to address the matters that give effect and purpose to the Act.
2.12 In all these applications (GMC 07012, GMD 08012, GMD07074, GMF07001) there has been an implicit acceptance that final decision making as to risk can proceed without sufficient data or reference to protocols or principles within the HSNO Act.
3.0 The Application is not a field trial.
3.1 Application GMF 07001 should never have been accepted by ERMA staff and Authority under a Field test code as it is outside the legal parameters of a field test but lacks the data for a Conditional release.
3.2 The applications GMF 07001 and GMD 07074 are for a Field test however the application is for an undefined amount of modifications and unknown constructs in a range of 9 domesticated animals namely, sheep, cows, buffalo, horses, goats, pigs, llama, alpaca in multiple unspecified facilities around the country. The applications are also taken to the level of commercialised production. In sum, they do not fit within the definition of a field test.
3.3 A field test is where significant data into the effects can be gathered. All details is lacking as to the experimental procedures that will be tested for and even what type of organism will be created. (HSNO Act interpretation: “tests into the effects of the organism under conditions similar to the environment in which they are to be released be conducted in a contained facility where the heritable material could be retrieved or destroyed after the trial.
4.0 Comparison of Field Trials by AgResearch, namely GMF98009 and GMF 07001
4.1 In GMF 07001 there are 9 species to be manipulated and a range of Nucleic Acid (DNA) and vector sequence identified for assessment by ERMA but no final organism construct is defined.
- In GMF 98009 the identification of the constructs to be created gave experts the ability to make an informed and robust scientific evaluation of the constructs. These have not been identified in this application.
4.2 In GMF07001 there is no stated purpose of what is to be field trialled to be evaluated by ERMA.
- In GMF 98009 three construct were identified and the stated purpose was defined.
4.3 In GMF07001 there is no information as to the gene modification to be tested nor description of the expression of the material or genetic modifications of the Organism that will inform ERMA as to controls.
- In GMF 98009 a detailed explanation of the modification process was defined.
4.4 In GMF07001 there is no mention of the nature and method and experimental procedures to be tested for ERMA to evaluate.
- In GMF 98009 there were experimental trials documented on the health of the animals, soil testing and milk disposal.
5.0 The Form NO-04 GMF 07001 under s:40 of HSNO the identity of the adverse effects p 42 -47 document is outlined
- unknown risks to the environment and possibility of the creation of toxins or disease causing organisms.
- There are recognised adverse effects on Taonga, Whakapapa, Mauri and Tino Rangatiratanga and loss of native flora and fauna.
- Animals and waste product may contain viable cells destined for disposal.
- Unknown effects from a self sustaining populations
- Unknown effects if it becomes a reservoir for human, plant or animal disease.
5.1 Yet, the applicant does not identify any experimental procedures to be used or seek to define how they will address/test for the nature of the adverse effects they have identified as required under a field test.
5.2 GMF 07001 further states that
- facilities are to be set up all around the country in different regions.
- Seeks an approval of unlimited duration (HSNO s:25 (3))
- Disposal of animals will be carried off site.
- Commercial activities to be carried out
- Transfer of old applications GMF 98009 and GMD 02028
- 9 different species are to be modified
- The host Organisms will be carrying disease producing vector sequences that could harm the environment and animal or human health.
5.3 These further points take the application GMF07001 it outside of the legal parameters of a field trial.
5.4 An indefinite, wide-ranging, multi-location commercial operation is tantamount to a conditional release application and should reasonably meet the standards required of such an application.
5.5 An approval of a conditional release is one that is informed by the findings of safety and published data on the effects of the organism in the field trials that have previously gone before.
5.6 How can submitters submit when this application lacks any information as to effects testing required in a field trial.
5.7 The applicant is forcing the ERMA committee to again make “broad exclusions to deal with classes of risk” in the two applications GMD07074 and GMF07001, which is contravene the HSNO Act principles and purposes, as they did with GMD02028.
5.8 Yet ERMA has not required the applicant to document any of the “known risks” or “adverse effects” of these trials or to include any peer reviewed published data on the field test to date of which GMF 98009 has been extended three times under a s: 67A with no published data as to why this experiment should continue or public accountability into the reasons.
5.9 Since the consideration of the GMF98009 and GMD 02028 the Act has undergone major changes.
5.10 The Act does not intend that generic applications are so broad that risk evaluation cannot be assessed.However testing for adverse effects that is required under such an approval as a field trial should be clearly specified and detailed in the application.
5.11 The applicant has stated that ERMA has considered the risk issues before.
5.12 However, the current ERMA Authority members have not been part of the decisions on GMD 02028 and GMF 98009 previous application.
5.13 The special Authority committee for GMF98009 was:
Professor Barry Scott (Chairman)
Helen Hughes
Bill Falconer
Dr Oliver Sutherland
Professor Colin Mantell
Leatrice Welsh (Māori Whakaruruhau expert)
5.14 The special Authority committee for GMD02028:
Jill White
Colin Mantell
Lindie Nelson
Jane Lancaster
Manuka Henare
5.15 The ERMA agency staff were also not part of the assessment team in prior applications.
5.16 The agency staff in GMF 98009 were;
Elizabeth Beale
Dr Baz Walker
Dr Abdul Moeed
Dr Deborah Read
Janet Gough
Bevan Tipene-Matua
Stephen Thornton
5.17 The Agency staff for GMD02028 were;
Suzanne Lambie
Parekura White
Dr Robert Hickson
Celia Haden
Dr Baz Walker
Dr Donald Hannah
5.18 The Agency staff for GMF 07001 are;
Dr. Libby Harrison
Mr. Asela Atapattu
5.18 The information in these applications is new to the Authority and Staff and it is wrong to pre suppose that the reason to not supply the information is because it has been accepted before.
6.0 Any new information sought
6.1 Further information seeks to clarify points raised in submissions. It does not seek to ask the Applicant to re-write the missing information. This is done when ERMA accepts the application and seeks information under a s: 52 before notification.
6.2 The applicant has stated that the applications must be approved as a whole. This is unacceptable to GE Free NZ.
We therefore ask that this suite of applications be declined before it goes to hearing.
Yours sincerely,
Claire Bleakley
GE Free NZ in Food and Environment.