2008 ERMA on AgResearch Applications GMC07012, GMD07074, GMD08012 and GMF07001 20-10-08

20 October 2008

Environmental Risk Management Authority

PO Box 131

WELLINGTON 6140

Submission on suite of four AgResearch Applications:

GMC07012, GMD07074, GMD08012 and GMF07001

PSGR confirms that it wishes to speak to this submission and does not require its details or submission to remain confidential.

This is a collective submission and covers all four Applications identified in the above submission title. This submission also includes a component that addresses AgResearch’s current and interrelated application for a 67A amendment of Parts 1 and 2 of GMF98009. All Applications were posted and became publicly accessible on the ERMA website at about the same time in August 2008.

In summary:

Under this umbrella series of Applications, AgResearch seeks approval to import into containment, organisms with a range of genetic modifications and maintain these organisms in containment for research, breeding and for the production of products with potential commercial Applications (GMC07012)…

AND

to develop in containment outside of a containment structure, organisms with a range of genetic modifications and maintain these organisms in containment for research, and for the production of products with potential commercial Applications (GMD07074)…

AND

to develop within a containment structure, organisms with a range of genetic modifications and maintain these organisms in containment for research, and for the production of products with potential commercial Applications (GMD08012)…

AND

to field test in containment, organisms with a range of genetic modifications and maintain these organisms in containment for research, breeding and for the production of products with potential commercial Applications (GMF07001).

AND

in a fifth application to ERMA, AgResearch has filed a request for a 67A amendment of GMF98009 that is inseparably linked to the four above. It asks for an amendment to existing stipulated controls governing the fate and disposal of unwanted genetically modified livestock and products currently at the Ruakura field livestock containment site when approval lapses in November 2008.

1. In this umbrella series of interacting but sparsely detailed Applications to ERMA, AgResearch’s declared intention is to import any or all of a wide variety of animals, animal cells, embryos, sperm, ova of about nineteen different animals and organisms, most with a range of undeclared or unknown genetic constructs, for the general purpose of research, breeding and production of a commercial smorgasbord of antigens, biopharmaceuticals, enzymes, hormones for commercial release. AgResearch contends that containment facilities, including those for the larger animal genera, may be sited in either the North or South Island and be operational over indefinite periods of time.

AgResearch observes that the existing animal containment unit at Ruakura (integral component of GMF98009 and GMD 02028, capacity of 200 dairy cattle) is currently on leased land close to residential areas. AgResearch is predicting the Ruakura containment facility may not be a likely site for AgResearch’s GE-livestock research activities being foreshadowed in these current Applications, but has provided no compelling justification for the likely rejection of the present containment facility. The sort of GE-livestock farming operations alluded to in their Applications may require approvable containment facilities elsewhere in such geographic areas as Waikato, Taranaki, Canterbury and Southland., A search of the Applications for any justification for the nomination of these provincial regions proved to be pointless.

2. In preparing these several Applications to ERMA, AgResearch has deliberately chosen a presentational style that PSGR considers borders on contempt of the relevant sections of HSNO legislation and therefore the basis of ERMA’s statutory obligations under the HSNO Act.

AgResearch makes it clear that, at least to it, it is unnecessary to provide ERMA with specifically requested information about the specifics of genetic modification of ‘animals, animal cells, embryos, sperm and ova’ cited in their application. PSGR contends that this deliberate exclusion of information precludes the ERMA Authority from foundation material that could enable it to determine and evaluate risks to public health from transgenic livestock maintained or produced as a consequence of these Applications. Realistic assessment of transgenic constructs in terms of risk probability is impossible.

In these Applications, AgResearch has gone so far as to seek approval to specifically import and develop any ‘animal, animal cells, embryos, sperm and ova’ organism that has been, or can be, genetically modified by any available technique known to AgResearch.

In an obvious contradiction of statements made in its Applications to ERMA, AgResearch (p18 of GMD0704) acknowledges that it knows that a prime requirement and purpose of HSNO is to provide ERMA with a detailed ‘organism description’ in Applications.

In this suite of Applications AgResearch has wilfully failed to do so.

3. In a further significant departure from the purpose of the HSNO Act (1996), AgResearch in these Applications is seeking approval of certain methodologies that could allow them to side-step a responsibility under the Act to give full regard to the intrinsic value of ecosystems [S6 (b)]. Not only has AgResearch declared the boundaries of field test definition – the crux of large livestock containment - have not been fully tested, it now openly claims there is no need to treat transgenic waste-materials (like milk) prior to final disposal.

With complete disregard for common environmental responsibilities, AgResearch brazenly proposes, resting on its claimed experience over eight years, that the disposal of GE-animals and wastes from a field containment facility (e.g. Ruakura site) does not now need to be restricted to the field containment site and proposes that disposals be made at off-site (no controls) locations.

With reference to Appendix IX of GMD07074, AgResearch continues to claim that horizontal gene transfer (HGT) of transgenic material to soil microorganisms at the Ruakura offal-pit disposal sites has not occurred. PSGR has every reason to believe that AgResearch methodologies and therefore HGT-detection limits are inadequate. Despite eight years of reported and unvalidated HGT-monitoring of the offal pits at Ruakura, we believe no such conclusion can be claimed to be valid.

The correct conclusion is much clearer and just as conclusive: ‘based on the monitoring work and methodologies reported in Appendix IX of GMD07074, no evidence of HGT occurring has been obtained, though HGT may have occurred but not detected.’

[Reference: Rizzi, A et al 2008. ‘Strategy for In Situ Detection of Natural Transformation-Based Horizontal Gene Transfer Events’ Applied and Environmental Microbiology 74 (4): 1250-1254.]

4. In a recent submission (14 August 2008), PSGR submitted to ERMA and the Minister for the Environment the following:

However, before any releases of GMOs occur, we strongly advocate that each formal Application to ERMA that seeks controlled release of a GMO should be required to provide complete scientific documentation of the intrinsic design of each new genetic-construct that enables its detection and identification during relevant HGT and LGT monitoring activities carried out under field conditions. No conditional release approval should be granted by ERMA without the applicant first providing ERMA with this necessarily relevant bio-security information.

Since the overall thrust of AgResearch’s present suite of Applications appears to be towards a potential scenario of commercial GE-livestock operations held under conditional (controlled) release, characterised by contradictory on-site or off-site waste disposal operations from GE-livestock containment facilities, PSGR recommends:

That each formal Application, in this case GMC07012, GMD07074, GMD08012, GMF07001, be required to provide complete scientific documentation of the intrinsic design of each new genetic-construct, either imported or produced by AgResearch, that enables the reliable detection and identification of that genetic construct during relevant HGT and LGT monitoring activities carried out on livestock field containment facilities. No approval should be granted by ERMA without the applicant first providing ERMA with this necessarily and detailed bio-security information.

In view of AgResearch’s current proposal to dispose of GE-livestock wastes off-site using methods that may include ‘incineration, burial, organic waste treatment (commercial or composting or spraying onto pasture)’, PSGR believes AgResearch has a statutory obligation to provide full details of the genetic constructs of all genetically modified organisms to be used, whether new or imported, as an integral feature of each application to ERMA. This way ERMA may reasonably expect AgResearch to be diligent and come forward with details of the monitoring methodologies to be involved that use reporter-gene systems that are realistically capable of in situ detection and quantification of HGT in GE-hotspots such as soil at GE disposal sites.

See press release 9 October, 2008, Environment Minister Trevor Mallard:

‘New GM regulations give greater assurances’

< www.beehive.govt.nz/minister/trevor+mallard >

5. S67A amendment of Parts1 and 2 of GMF98009.

[Note: Although amendment Applications are usually processed without inviting public comment (i.e. non-notified), this Application is posted on the ERMA website and is bound to attract comment because of its close links to the four other Applications above.]

PSGR considers any assessment of this Application is highly problematical, as the applicants no doubt also appreciate. Should no other appropriate approval plus controls come into existence, then no case exists for a simple transfer of the GE-livestock in question. Because PSGR is recommending that none of the current AgResearch Applications be accepted, this amendment to GMF98009 should also be declined and the controls remain unchanged and approval expiry allowed to take place as authorised.

A significant question has been raised by a particular entry in this Application. Under ‘Reasons Amendment Sought’ section 5.1 of the Application, AgResearch submits, ‘it would wish to continue research and commercial activities with the cattle developed under approvals GMF98009’. To our knowledge, no approvals for GMF98009 were authorised to permit any commercial activity. It is clearly important that details of any undisclosed commercial activities that have actually occurred now be made public by ERMA and AgResearch.

Recommendations of PSGR:

None of the Applications GMC07012, GMD07074, GMD08012, GMF07001, and 67A amendments to GMF98009 Part I and II are to be approved by ERMA for the following reasons:

· The Applications are deficient in fundamental technical information required by ERMA, including details of the molecular characterisation of new organisms and their transgenic constructs to be used in the testing and development of transgenic livestock

· Proposals by the applicants to dispose waste materials from transgenic livestock operations off-site should not be authorised. ‘Off-site’ is taken to mean ‘not in containment’ under HSNO, and includes undocumented geographic locations and, consequentially, unknown interactions with the receiving environments..

· The Applications are defective because they reveal no details of either the transgenic constructs of the new organisms involved, or of any planned scientific commitment to develop effective reporter-gene methodologies to detect and quantify the release and transfer of animal transgenes from GE-livestock hotspots to the natural environment.

· PSGR recommends that Applications GMC07012, GMD07074, GMD08012, DMF07001 and 67A amendment to GMF98009 Part I and II not be approved in perpetuity as all five Applications are directly or indirectly seeking to do.

PSRG wishes to present this submission in person.

Compiled and signed by Dr A Neil Macgregor, Trustee

On behalf of the Trustees and members of PSGR

Paul G Butler, BSc, MB, ChB, Dip. Obst. (Auckland), FRNZCGP

General Practitioner, Trustee PSRG, AUCKLAND

John R Clearwater, BSc, MSc, PhD

Principal Scientist, Clearwater Research and Consulting, Trustee PSRG, AUCKLAND

Bernard J Conlon, MB, BCh, BAO, DCH, DRCOG, DGM, MRCGP (UK), FRNZCGP

General Practitioner, Trustee PSRG, MURUPARA

Elvira Dommisse BSc (Hons), PhD, Mus.B, LTCL, AIRMTNZ

Scientist, Crop & Food Research Institute (1985-1993), working on GE onion programme.

Michael E Godfrey, MBBS, FACAM, FACNEM

Director, Bay of Plenty Environmental Health Clinic, Trustee PSRG, TAURANGA

Neil Macgregor, BSc, MSc, PhD

Soil Microbiologist, Institute of Natural Resources, Massey University,

Trustee PSRG, PALMERSTON NORTH

Peter R Wills, BSc, PhD

Associate Professor, University of Auckland, Trustee PSRG, AUCKLAND

Robert G Anderson, BSc, PhD

Lecturer retired, Trustee PSRG, TAURANGA

Jean Anderson

Businesswoman retired, Trustee PSRG, TAURANGA.

Ends

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