10/12/2006

GE Free Submission to ERMA on GMF 06001 (Bt Brassica)

GE Free New Zealand
In Food And Environment Inc.
PO Box 693, Nelson
gefree@ts.co.nz www.gefree.org.nz

SUBMISSION to: Environmental Risk Management Authority, PO Box 10559, Wellington

Re: GMF 06001

10/12/06

Dear ERMA,

We would like to be heard in relation to this application.

GE Free (NZ) recommends that ERMA decline this application for a field test

Introduction
This submission is in two parts.
Part one details specific issues raised by the application and summarises key reasons why we request ERMA decline the application.
Part two provides additional commentary on the issues raised, and includes information necessary for ERMA to undertake its assessment of the cost/benefit, economic, and cultural issues central to this application.

A bibliography is provided for Part One with other references included in the body of the text in Part Two.

Background
GE Free NZ (in food and environment) is a community-based non-profit organisation, with no political affiliations. It is run on the voluntary contributions and donations of over a thousand members and supporters. We also represent the concerns of many hundreds of thousands of ordinary New Zealanders who have shown in submissions to the Royal Commission on Genetic Modification, and in independent polls, to desire the protection of the environment and the “GE-free option” as part of Aotearoa New Zealand’s ethical and culturally-appropriate application of gene technology.

As a community organisation GE Free NZ (in food and environment) is committed to public education and dialogue. As well as participating in community group meetings with ERMA, GE Free NZ (in food and environment) advocates for the public interest in relation to the rights of people to buy, grow and manufacture food that is not contaminated with GE constructs, and advocates for the national interest in protecting the capacity of New Zealand to produce and export high-quality clean, GE-free produce.

Overview
We believe a proper cost-benefit analysis will reveal no real benefits from the trial or long term future benefits from commercialisation.
As well as the existence of alternative methods to reduce use of agricultural sprays, commercialised Bt Brassica crops would negatively affect other farming systems like organics and conventional and IPM management. The protection on diversity of indigenous flora and fauna and management of naturalised plants on TLA’s or DOC lands, the ability of communities to choose to buy GE Free Brassica vegetables, or to make their livelihood in growing GE-free produce are risk factors that significantly outweigh purported benefits of the trial.
Application GMF 06001 poses a significant risk to New Zealand’s reputation as a food producer, and to community confidence in the way gene science is being driven and regulated.
Given omissions and other shortcomings in the content of the application, the absence of a credible purpose, no properly identified research methodologies, and the option for more comprehensive and genuinely useful research to be conducted in secure glasshouse or laboratory containment, we ask that ERMA decline this application.

Yours sincerely,
Claire Bleakley
President of GE–Free (NZ) in food and the environment


PART ONE

We believe that there is much evidence in GMF06001 that the applicant has not evaluated thereby showing the integrity of the application is lacking
The data provided does not cover the risk, costs and other impacts associated with the application which relate to the safeguarding of the life-supporting capacity of the air, water soil and ecosystems.

The application does not adequately address the nature and method of the field trial or all the possible adverse effects.

It does not address the long term effects of this application in regard to the purpose of the trial.

It does not appear to have discussed and produced documentation on previous trials relating to the safety of Bt Brassica for human or animal consumption.

The applicant did not critique or compare potential impacts of Bt on the soil biota using published science articles

There is a minimisation of risk and the assumptions that are not supported by published findings.

There is no purpose to the trial: a reference to commercialisation in the Maori consultation is not clarified as a purpose elsewhere in the application. There is no evaluation on the large body of international scientific publications on the risk effects on soil and ecosystems.

There is no adequate consideration of the differences in natural and synthetic cry, nptII genes. The synthetic Bt gene is expressed differently to the naturally occurring gene.
The evaluation of the Bt, Agrobacterium and CaMV promoter DNA sequences is missing.
It is not possible for the public or independent scientists to investigate the applicant’s assumptions as key data are not available to be assessed.

There is limited relevance in references to potatoes and pine trees that are not Bt expressing.

The application states that only plants expressing Bt toxin at levels that have 100% mortality in larvae will be planted, (p 17, 4.4).
• How then will the effects on the environment be assessed?
As a central concern for this trial is the development of insect resistance
• Why will they be ensuring that all larvae are removed and destroyed?
If the applicant is looking at agronomic performance and the efficacy of Bt as an insecticide, the proposal to remove insects that survive will invalidate the data.
Research may be useful to study surviving insects if they are removed but not destroyed to understand mechanisms of resistance and how resistance is inherited, but this can be done in full containment.
• Why will they also be carrying out a regular spray regime that will impact that?
If they are looking at long term Horizontal Gene Transfer (HGT) and effects on soil ecosystems
• Why are they removing all the plants and disturbing the soil ecosystems?
A fully contained purpose-designed greenhouse environment would allow the effects of plant growth and environmental effects in undisturbed soil to be studied more effectively

These fundamental flaws suggest the project is not a useful field trial to deliver deeper scientific understanding to inform risk-management but may be serving other purposes such as seed multiplication as part of a commercial operation. If this is the case moving plants into the glasshouse may be to control cross-pollination and ensure seed purity.
ERMA cannot condone or approve application 06001 as it fails to adequately describe the scientific research methods or outcomes expected, or give credible aims for the trial.

Background on Brassica
Brassica oleracea (Cabbage, Brussels Sprouts, Broccoli, Kohlrabi, Cauliflower, Kale)
origins were from Europe and the Mediterranean. Brassica have been used as a vegetable for more than 2500 years and through selective breeding for particular characteristics of the plant, six main vegetables have been produced from this one species.

A study by Heenan P., Fitzjohn R., Dawson M , (2004) on naturalised Brassica in Canterbury found there is a “significant taxonomic and morphological diversity of naturalised Brassica species” (p. 816). The most common naturalised Brassica being wild turnip (B.rapa. This is a mix of the hardiness traits of B.napus (forage kale) and improved leafiness and re-sprouting ability of B rapa var oleracea (bulb turnip) thus Wild turnip is B. campestris subs rapa var oleracea or B.rapa. The ability for all naturalised weedy relatives to gain the advantages of selective plant breeding, even plants with F1 hybrid genes is of concern as it shows the ease with which any breeding trait can quickly out cross.

In the same study on cytometry data on naturalised population sizes found individual plants belonged to four species with one putative hybrid. The study also found that that B. rapa var oleracea and B.napus crossed readily at frequencies of 87.9% (Heenan et al., 2004)
Further, the most common occurrence for establishment of weedy Brassica species was created by soil disturbance and open habitats. Seed harvesting and transport along roadsides and field margins are the most common forms of distribution. (p.830)

In the Wrightsons submission to MAF in 2003, Dr Stuart Gowers, forage brassica breeder from Crop and Food Research , documented Brassica spp as “highly promiscuous, and crosses occur readily between all species within the genus either directly or via an intermediary. Cross pollination will occur within each spp and between species of B.campestris, B napus, B.oleracea, B. nigra, B juncea”.

Direct contamination is able to occur by pollen transmission from GM canola crops to forage brassicas and/or vice versa. Indirect contamination may occur from dropped GM canola seed or buried seed where forage Brassica have been grown.

Pollination occurs via wind and insect vectors over a large distance. Howlett and Walker in Otago were surprised by the many native insects that pollinate Brassica spp. they observed that in Lincoln and Gore pak choi (Brassica rapa var chinensis) plantings had native bibinoid flies in numbers up to 10 times more than honey bees and carried the same amount of pollen grains.

5.2 Identify all potential adverse effects of the organisms, potential adverse effects on the environment, in particular on ecosystems and their constituent parts.

Genetic modification is a new technology and it is important that applicants provide rigorous and well-evaluated data. This application lacks detail or evaluation of the large body of research literature already published.

As stated above: there is no purpose, and if we make the assumption that commercialisation is expected, then Heenan et al, 2004 study should have been evaluated by the applicant. There is an enormous potential cumulative future effect on communities’ economy and social and cultural livelihoods, if Bt plants either out-cross with any wild or weedy species in the Brassicaceae.

GMF 06001 application states (p21,)
“In Australia GMO’s containing combinations of these genes…..have been field tested with no reports of adverse effects on human health or the environment resulting from these releases”. http://www.ogtr.gov.au/rtf/ir/dir052finalrarmp.rtf

The link points to The Australian Gene Technology Regulator’s (OGTR) decision to issue a licence for a rice field test to run over three summers starting in 2005 and ending in 2008.
The quote infers that the field tests have been completed and mentions release. This is misleading and the erroneous reference to “no adverse effects from these releases” calls into question the rigor and expertise with which the applicant has verified the accuracy of the information provided. The reference to a release is misleading and is made without any provision of published data.

The numerous field trials on the OGTR site relating to reporter and marker genes are difficult to evaluate. It appears that the field trials on the web site are still under “post harvest monitoring” (PHM) or “current” and there are no scientific references to any published environmental or human tests.

The inaccurate and misleading information requires ERMA to apply greater objectivity and expertise in its scientific verification processes.

The actual rice trial referred to is just beginning its second season and on examining all OGTR GE site information there is no reference to environmental or safety testing. In New Zealand the field trials conducted on the earlier Brassica spp (IAG 53,54) did not submit safety data to ERMA.] This is a direct breach of HSNO 1996 regulations on the approval of field tests and their effects.

The absence of such data for public scrutiny and inaccurate reference to other data is concerning and risks further undermining public confidence in the scientific and regulatory process. It is inexcusable for genetic scientists to make such unscientific assumptions and ERMA must address this in their deliberation. Use of inaccurate information by Crop and Food, unless challenged by ERMA, effectively breaches statutory responsibilities under the Act to protect the environment and consult fully with communities.

The applicant states 5.2 “Bt has little impact on soil biota - earth worms, collembolans and general soil microflora”. Antimicrobial potatoes showed “very minimal impacts” on soil microbes indicating that changes were found, though “studies on Pinus radiata have shown no significant effects on rhizosphere bacterial and fungal communities” (p21, last para).

However, there is a large omission in addressing the failure of a field test in which16 Picea abies trees had to be destroyed due to disease and stunted growth . This could very possibly have been a result of direct or indirect effects of the transgene and how they affected the soil and immediate environment around the plants.

The two studies outlined were not Bt specific. This variance in success between similar species with the same engineered traits indicate that there is no reasonable way that results from one plant type can be extrapolated to the other.

It is also disturbing to see the speed with which vital research material is destroyed without scientific examination to better understand failure. This is repeated constantly in much CRI research into GE and still ERMA approves new flawed research without waiting to see and understand the outcomes of previous research that would allow for scientifically-informed and credible risk management decisions.

It is noted that the PPL GE sheep trials were terminated and data destroyed in the absence of funding for research on the animals that could guide future ERMA decisions. The inability of ERMA to influence or require such research under the current HSNO Act is in itself exposing New Zealand to ongoing significant but unmanaged risk. There is still a paucity of information after seven years of AgResearch GE cow experimentation yet ERMA has extended the trials without the required data on the effects on the environment.

We conclude this section with a quote from Prof. David Williams, a New Zealander carrying out medical genetic engineering at the San Diego School of Medicine, California:
“I’m afraid that most of us who work with transgenics are pretty uncritical. Most of us assay for the transgenic product and ignore the secondary effects. Even those people doing functional genomics on transgenics mostly ignore changes that ‘don’t make sense’, i.e., cannot be seen as immediately attributable to the transgene.

Hence it’s hard to get an idea of the extent and prevalence of downstream effects from insertional mutagenesis and simply imbalances cause by transgene expression. The biggest risk is that we don’t know. The problem with transgenics that are released into the environment and used in the food supply, however, is that the potential consequences of deleterious unknowns are clearly greater.”

There are important Bt studies on soil that are not addressed in the application.
Stotzky found that the insecticidal protein of Bt were persistent in clay and humic soils.
The fate of Bt-derived proteins and the effects on the environment include:
• rapid and strong binding on clay and humic substances
• accumulation of toxins resistant to bio-degradation
• enhancement of selection of toxin-resistant target organisms
• retained insecticidal activity hazardous to non–target organisms
• persistence in the soil under both aerobic and anaerobic conditions
• reduced metabolic activity (CO2 evolution) and impacts on the activity of some enzymes in soil, linked to Tg Bt corn
• Toxin was detected in root exudates

Lukow, T., Dunfield, PF., and Liesack W., (2000) study on non transgenic and Transgenic pottoes outlined
“The statistical treatments clearly revealed spatial and temporal effects, as well as space×time interaction effects, on the structural composition of the bacterial communities. Use of the T-RFLP technique to assess spatial and temporal changes in the bacterial community structure within an agricultural soil planted with transgenic and non-transgenic potato plants”

Donegan et al (1994) found that there are changes in levels, species and DNA finger prints of soil micro organisms associated with Bt cotton. This was seen by transient changes in bacterial species composition.

The applicant states that potential adverse effects are “thought to be negligible”. This statement is misleading as there is a large amount of data published confirming that ecosystems are being detrimentally affected.

The incomplete evaluation is non-scientific and shows a failure by the applicant to address the requirements of the application-process, namely to assess all potential adverse effects. This would indicate that the application should be immediately declined.

In the absence of rigour in considering international data and alternatives to the trial, there is creation of an additional risk that the process results in a rush to commercialise untested unsafe products based on an inadequate scoping of complex issues. Given the likelihood of accidents through human error (as evidenced by recent failures by MAF in border-testing imported seed, and in US farmers failing to maintain ‘refuges’ required for insect-resistance management) this can also endanger public health, the economy and the environment and leave the public to unfairly bear the cost as we today for other ‘socialised’ risks.

Future Effects;
There is published evidence that resistance and extensive out crossing occur in both the insects and the plants. GMF 06001 could not reach commercialisation without significant contamination and liability issues which remain un-addressed. As no insurance company world wide will give GE cover, and Brassica are highly promiscuous. GMF 06001 will threaten present and future generations’ livelihoods, health and the environment. The use of Bt in forage Brassica is also questionable as few sprays are used as it is grown in mostly winter months when caterpillars are pupating.

If the trial’s outcome is commercial use, pollen is inevitably going to escape into the wild with the potential to create a large Bt sink acting like a refuge for resistant insects.
The adverse effects would be irreversible as Bt is a living organism and has potential to transfer genes from plants to fungi or bacteria.

The Institute of Health and Environmental Research (IHER), based in South Australia, writes in their canola submission to the OGTR

“There have been several examples of the transfer of genes from plants to fungi or bacteria. There are concerns that transgenic DNA could be involved in this process more readily than normal DNA, due to the nature of the gene sequences, in particular the gene switches which are designed to allow integration of foreign genes into a host. Already, engineered genes introduced into Datura, Brassica, and Vicia species have been shown to be transferred to the fungus Aspergillus niger” (Hoffmann et al, 1994).

Pre-ERMA approvals of IAG 53, 54 were for carrying out of field trials on the effects of the organism under conditions similar to those of the environment into which the organism is likely to be released. Though the field trials have been conducted for the last 16 years there are no significant data on health and environment yet produced. This situation, and its continuation in the form of trials that will not deliver useful risk-management data, represents a failure of the process to meet the intention of Parliament for genuine scientific knowledge to be gained from field trials.

HGT:
IAG 43, 53, 54 and 60 have never had the site tested for HGT even though monitoring for plants is being conducted until 2007. the extended controls require monitoring of the sites to be carried until no plants are found why was soil not included?.
AgResearch is still - after seven years - unable to test for HGT. There were no HGT studies conducted on the PPL trial site. There has been a documented change in levels of bacteria puromycin and Kanamycin in offal sites and the surrounding area where transgenic animals have been disposed of. If field trials are to be conducted diagnostic tools for the data gathering have to be created first. Trial sites have never been tested for Tg recombination as the tests are still being developed in Italy .

Finally, it is clear from published research that environmental harms can arise from HGT occurring at frequencies that are too low to be detected by the methodologies used in current HGT monitoring being conducted in New Zealand (Heinemann and Traavik, Nat. Biotech).

It is the obligation of the applicant to show that they could detect HGT at frequencies relevant to causing an environmental harm before the risk of HGT is dismissed as negligible. Use of unqualified terms implying low frequencies are not helpful: what is useful is for the applicant to assure ERMANZ that the frequencies are below those that are estimated to be relevant. In the literature, those frequencies are 10-17 to 10-24, and are probably in excess of a factor of 1012 (a factor of a 1000 billion) below the best resolution of any field monitoring experiments being conducted in New Zealand at present.

Significant deterioration of natural habitats
This application has not addressed the possibility of long term risk from the significant deterioration of natural habitats if Bt in future became naturalised. As Heenan et al (2004) reported the ability of weedy species to take on the advantageous traits of re sprouting and hardiness and then Bt, presents significant sustainability problems and deterioration of natural habitats on all trophic levels ranging from resistance, to secondary and tertiary ecotoxic effects on herbivores and predators. Bird life would be affected with the loss of insect life, and mineral re-cycling affected with potential long term damage to valuable soil ecosystems that could last for generations. The need to revert to a high spray regime as has occurred in parallel situations involving commercial GE crops overseas would destroy the main claimed benefit of the trial.

The application fails to properly identify these risks and lacks evidence concerning out crossing with native Brassica. The assumption that it will not cross is not based on scientific grounds but is only supposition. GE in itself, means it has already breached species boundaries.

The Cruciferae Cooks Scurvy Grass Lepidium oleancerum a New Zealand indigenous plant threatened with extinction in the wild in the next 20 years. This threat is compounded if Bt was to escape become established in wild Brassica plants.

The unidentified adverse effects on genetic diversity of common naturalised Brassica species –charlock, swede, turnip, rocket and well as indigenous Cruciferae Cardamine debilis, Lepidium oleraceum, Rorippa palustris cannot be assumed to be negligible and expert witnesses need to be consulted.

The ability of the organism to form self sustaining populations
There is evidence that the Bt gene can persist in soil for up to 140 days. Exudates containing the toxin have been taken up and found in soil microbes.

The Adverse Economic Effects from the ability of the organism to form future resistant populations
DBM resistant to Bt spray show resistance to Bt broccoli and it is likely this finding would also be reversed: insect resistance to Bt Tg brassica would confer resistance to Bt sprays. This would severely impact on Organic and conventional production to the extent that it could be argued that it was anti-competitive, unsustainable economically and would severely impact on all market gardeners’ and farmers’ livelihoods.

The ability to cause disease or become a vector for human, animal or plant disease.

As the Bt construct is actually the “organism” and its first host was e-coli which is common in ecosystems as well as all gut flora it is very possible that the gene construct could re transform and combine with any of these ecosystems in any ecosystem. The binary vector backbone was in found in all Kestrel constructs and the Grunner 1Ca5#1a (appendix 2).

• What does this mean in relation to ERMA’s regulations in HSNO schedule 2?

• will there be an assurance that plants containing the vector backbone will be destroyed?

Further, the concerning documentation of animals (sheep) dying after eating the leaves and chaff of harvested Bt cotton, and the severe effects of workers who picked the Bt cotton must be fully examined before any field trial on GMF 06001 can be considered.

The precautionary principle must be applied before any further filed trial begins. A full independent feeding study on the long term effects of Bt Brassica must also be conducted.

Ability to cause animal disease
There is a recently completed trial by CSIRO scientists on Peas (Pisum sativum) genetically modified to contain a gene from the common bean (Phaseolus vulgaris L. cv. Tendergreen). The trial had very good results on weevil toxicity however after ten years when feeding trials were conducted serious problems were identified.

“Subsequent feeding tests on laboratory mice were able to confirm this difference. For four weeks, one test group was fed transgenic peas, while the lungs of another test group were given GM pea aerosol treatments. The tests revealed immune reactions among test animals”:
• Mice fed GM peas had elevated levels of antibodies in their bloodstream.

• The lungs of mice directly treated with the aerosol made from GM peas had above average levels of inflammation.

• Other allergy test for skin reactions also indicated serious problems. Cross-reactivity was found between this pea and other allergens - in other words, the pea suddenly made the mice allergic to other things that they were previously not allergic to

Control groups treated with conventional peas or beans did not have these changes.

The peas were destroyed and no testing carried out on humans.

In animal studies Monsanto found that RR canola the CP4epsps gene affected the mice by increasing the weights of the internal organs. Schubbert R., Rentz D, Schmitz B and Doerfler W , found the transgenes were absorbed through the intestinal wall into the lymphocytes, spleen and liver of mice. It had even transferred through the placental barrier to feotuses of mice. The transgenes have shown transformation activity in sheep saliva, rumen and silage effluent. More and more studies are finding a dangerous link to possible chronic illness associated with GE.

The Monsanto study from the feeding data on Mon 863 found that the GE corn plant is made up with the Cry3Bb1 insecticide gene, the 35S promoter (Cauliflower mosaic gene) and a neomycin resistance gene marker gene NPTII (neomycin phosphotransferase II).

In the feeding studies on rats for 90 days it found there were
• Significant changes to the white blood cell counts;
• Inflammation and deformities in the tubules
• Lower weights of the GE rats kidneys.
• An increase in the glycaemic index in females.

This highlights the detrimental effects to animal health in the short time they were eating the Corn. If these adverse organ changes are happening to the animals, what is happening to people who eat this food every day for a lifetime? Our food instead of keeping us healthy could be harming us: we could see a rise in diabetes, kidney malfunctions and immune deficiency disorders.

Ability to cause human disease

1. Independent studies published in the last ten years show many problems with the introduction of GE into the food chain. Netherwood T, Martin-Orue SM, O’Donnell AG, Gockling S, Glibert H.J., and Mathers JC, (1) has published research into the ingestion of GE Roundup Ready (RR) soy in the human gastro intestinal system. This study shows that full-length CP4epsps transgenes do survive the small intestinal digestive process.

2. In the Netherwood T, Martin-Orue S.M, O’Donnell A.G, Gockling S, Glibert H. J, and Mathers J.C, (2004) study the CP4 epsps gene (CaMV and agrobacterium spp) survived the digestive juices and in fact were found in trace amounts in gut flora, leading to the recommendation that more safety studies should be conducted. The Netherwood et al study accentuates that people with all kinds of illness especially people with types of digestive tract illness and irritable bowel problems would be most at risk of severe illnesses, possibly even cancers as a result of GE inserts.


3. As there is no clinical diagnostic test if the physician suspects such a probability of GMO adverse effect, there can be no assurance that the occurrence of non-specific digestive illness could not be attributed to the ingestion of GE. It is false to assume that GE- related illness does not occur because it has not been observed as there has been no clinical testing available to medics to test for it. There must be a diagnostic test available to trace adverse reactions before release for health and safety reasons.

4. The CaMV virus is prone to fragmentation: this could cause DNA rearrangements, deletions, translocations and other disturbances (Wan Ho 2003) leading to new toxins and proteins in the foods that are dangerous and not able to be tested for.

5. The CaMV could have been the reason for the “growth factor effects” in rats’ organs and intestines reported in Monsanto’s studies.

6. Ampicillin is a common antibiotic for chilhood infections. If common foods containing the AMP resistance gene are eaten as part of the diets of babies and children resistance would evolve rapidly, threatening the effective treatment for ear and throat infections.

In light of this the Authority cannot make any decision on GMF06001 before feeding studies have been conducted on the long term effects of the Tg Brassica on animal and humans.
No cost-benefit analysis can be completed, and no benefit for the trial can be claimed or assumed until tests have shown the products are not as toxic as the experimental peas in Australia proved to be.

The precautionary principle requires that ERMA prevent and manage adverse reactions. Only in a glass house would both conditions be met as the test would be managed in a controlled environment therefore preventing any escape.

The applicant has not shown scientific rigor in other areas of the application as the information provided goes to show.

The Triangle of U (1986) appendix 1 is misleading and confusing. There is no explanation to back up the document. It is also interesting to note that valuable research done by NZ Crop and Food Research (undated) conducted by Dr Stewart Gowers, Forage Brassica breeder into inter and intra genus crossing is not detailed. The use of unpublished statements of opinion and posters in the reference section does not reflect robust scientific objectivity. The use of selective information is concerning as, if we are to advance and have robust scientific data, objectivity must be apparent and scientists must be able to accept and critique all evidence rather than only look for what they are paid to see.

There is now a substantial amount of published material on Bt not covered in this application. It is also concerning to see that only selective expertise has been sourced when scientists at the University of Canterbury and ESR have not been consulted.

It then begs the question who is going to evaluate and provide this missing information of all the possible adverse effects of the organism on the environment? Will ERMA independently pay and seek the advice of these experts to ensure acceptable standards for risk management are achieved and are credible to the broader scientific community and the public?

The applicant has shown GMF06001 is highly toxic to DBM and CWB (Appendix 8, p. 82) The feeding patterns presented in fig 18 show only show two cabbages one non- Bt and one Bt Tg. We do not know
As the Brassica spp are the main host plants to these insects
• how will the loss of host food affect these insects and what will it do to the trophic levels in relation to the food web?

• It appears that Bt is toxic to more than the target caterpillars, no one knows its effects on New Zealand butterflies or ecosystems.

• There is also a major flaw in the findings as no experiment was done to show what manually applied Bt powder would do.

• As has been stated by the applicant 30 years of Bt use by Organic farmers and around 10 years in conventional use has shown little toxicity or adverse health effects. This is because manually applied Bt breaks down in the sunlight and rain and can be washed off when prepared for cooking so that no residues are detected in food plants when eaten. This context is very different to one where Bt toxin is expressed from within plant cells.

• ERMA must look at the alternative ways to deliver sustainable solutions in contrast to those claimed for this trial. Bt used in manual application is a proven non toxic alternative that is cost-effective: like other Integrated Pest Management (IPM) and organic management techniques there are alternatives that can address pest issues without the negatives of the proposed trial or the impossibility of commercial use without contamination of conventional and organic production.

• Cerda, Saayed and Wright (2006) reported that the DBM (plutella xylostella) developed 100 fold resistance after five generations if there was no refugia and 8-25 generations in plots that had 50% refugia. The known rate of failure (c20%) amongst US farmers in maintaining refuges in practice must also indicate a risk factor mitigating against the viability of the trial’s claimed benefits.

• It is certain that GE Bt resistance would directly affect manual control insecticides that include DIPEL ES, AGREE WDG, FORAY 48B by eliminating a safe and effective tool for DBM, CWB caterpillar and moth control for all orchardists and horticulturalists. This is a massive risk for all growers and would severely affect the ability of communities to maintain and enhance their economic and social wellbeing for this and future generations.

• This trial is outside, it will be open to insects, rodents, rabbits or rats passing through the site and leaving the site to mate and spread material outside of the facility. Walker and Howlett, 2005). Though the applicant mentions sprays are to be used to manage some incursions, including aphids, there is no method indicated on ways to control the full range of escape vectors.

• The lack of clarity in the application relating to all aspects of data collection, including what data will be of value for risk-management purposes, is exemplified by the claimed intention to target the Soybean Hopper as one of the pest insects. How is this to be done given the applicant states this insect does not occur in the south island where the trials are proposed.

• A stated objective of this application was to reduce chemical application on plants. However how will it be measured? How credible or useful will this be if alternative methods like organic husbandry are not a control for the trial?

Summary: ERMA must consider alternative solutions.
The experiments in the application- if deemed suitable to proceed at all can be fully conducted in contained glasshouses and laboratories. This would significantly reduce the risk and would also allow more rigorous testing using controlled input of variables and targeted study.

Feeding trials
The carrying out of feeding trials (using green-house produced material) prior to any field trial would indicate if Bt brassica are safe to eat. The Institute of Health and Environmental Research Inc in Australia is set up to conduct independent trials on GE food safety, I refer you to their submission on Canola to the OGTR. It is imperative to fully safety test the Brassica before proceeding with the trial as it is not acceptable to have a repeat of the CSIRO pea trial.

HGT and soil compositions
Testing for effects of HGT and soil ecosystems can be carried out in grow bags, like ESR, plant material can be cut into soil media of different ph, structures and clay humic compositions replicating the Stotzky studies.
This would not be a problem as the plants are being moved to the glasshouse after four months anyway.

Persistence and pesticide reduction
Measurement of persistence effects of Bt would be more robust as containment would limit the need for confounding results: proposed use of pesticide sprays in this trial would be massively reduced as the researchers who were picking off the caterpillars could be utilised for weeding and removing aphids.
Glasshouses have problems with many insects like white fly these could be observed for fecundity and tri trophic effects as controlled levels of predators could be introduced.
Only a few pots would need to be replaced regularly.

Environmental conditions
Glasshouse environments could be controlled with wet and dry and windy conditions.
Pest insect populations can be managed effectively in a similar but less risky way than proposed by the applicant who states artificial populations may be introduced in the field
Soils would not be disturbed so ecosystem effects could be developed without too much disruption, fungi, microrhyzza, nematode and earthworms all introduced to observe effects.
The grow bags could be re planted to see how ecosystems were affected by generational plantings. This could be done continuously there fore cut down on the time of the trial.

Resistance
Larvae can be released into contained glasshouses replicating Cerda et al DBM studies where canola plants were grown in pots and replaced as they were eaten. Robust findings were published without endangering the environment or non target organisms.

GE Seed production and containment
Even if approved to proceed in greenhouse containment 10 years of allowing Brassica seed multiplication will create an over abundance of seed. This seed must be destroyed yearly leaving only enough to carry on with the experiments. At no time can seed from this trial be removed off site or exported.

A contained and comprehensive series of studies as outlined above will give tangible scientific data and understanding that is missing from the experiments indicated in the application. Only a few plants need to be grown, so in ten years there would be robust publishable data on the usefulness, risks and safety of such Bt crops.

PART ONE - Bibliography:
1. Cerda. H, Sayyed.AH and Wright DJ, (2006) Diamond back moth resistance to Bacillus thuringiensis transgenic canola: evaluation of refugia size with non-resessive insects. J. Applied Entomology, 130(8), 421-425.
2. Chowdhury EH, Kuribara H, Hino A, Sultana P, Mikami O, Shimada N, Guruge KS, Saito M, Nakajima Y. Detection of corn intrinsic and recombinant DNA fragments and Cry1Ab protein in the gastrointestinal contents of pigs fed Genetically modified corn Bt11. J. Animal Science 2003, 81, 2546-51
3. Donegan K.,Palm C., Fieland V., Porteous L., Ganio L., Schaller D., Bucao., Seidler (1995) Changes in levels, species and DNA fingerprints of soil micro organisms associated with cotton expressing the Bacillus thuringiensis var kurstaki endotoxin. Applied Soil ecology 2, 111-124.

4. Effects of CP4 EPSPS gene on Canola studies in rats 1994, 1995,
1996. `http://www.monsanto.com/> www.monsanto.com

5. Impact of Bt Cotton on Farmers Health investigation report Oct-Dec 2005.
6. Impact of Bt Cotton on Farmers’ Health (in Barwani and Dhar District of Madhya Pradesh) Investigation Report, Oct - Dec 2005, www.GMWatch_org.htm
7. Independent Science Panel (2003) The case for a GM- Free Sustainable World, Institute of Science in Society, London UK.
8. ISIS Press Release 03/05/06, Mass Deaths in Sheep Grazing on Bt Cotton http://www.i-sis.org.uk/MDSGBTC.php
9. Kilbourne E et al (1996), Tryptophan produced by Showa Denko and epidemic Eosinophilia-Myalgia Syndrome, Journal of Rheumatology supplement, 23: 81-92.
10. Mortality in Sheep Flocks after grazing on Bt Cotton fields, – Warangal District, Andhra Pradesh,Report of the Preliminary Assessment, April, 2006 www.GMWatch_org.htm
11. Netherwood T, Martin-Orue SM, O’Donnell AG, Gockling S, Glibert H.J., and Mathers JC, (2004) Assessing the survival of transgenic plant DNA in the human gastrointestinal tract Nature Biotechnology; 22; 204-209
12. Palm C; Schaller D; Donegan K; Seidler R (1996) Persistence in soil of Transgenic plant produced Bacillus thuringiensis var kurstaki delta endotoxin. Canadian J. of Microbiology 42(12), 1258 -1262.
13. Pusztai P (2001) Genetically modified foods: are they a risk to human/animal health? http://www.actionbioscience.org/biotech/pusztai.html
14. Report of the Preliminary Assessment, Mortality in Sheep Flocks after grazing on Bt Cotton fields – Warangal District, Andhra Pradesh, released April, 2006, http://www.gmwatch.org/archive2.asp?arcid=6494
15. RI Vazquez Padron et al (1999) Intragastric and intraperitoneal administration of Cry1Ac protoxin from Bacillus thuringiensis induces systemic and mucosal antibody responses in mice. Life Sciences, 64, 1897-1912.

16. Saxena D., Flores. S., Stotzky G (1999) Insecticidal toxin in root exudates from Bt corn Nature, vol 402: 480.

17. Schubbert R., Rentz D, Schmitz B and Doerfler W, (1997) foreign (M13) DNA ingested by mice reaches peripheral leukocytes, spleen and liver via the intestinal wall mucosa and can be covalently linked to mouse DNA. Proc.Nat.Acad. USA, 94,961–6.
18. Stotzky G. 2000, Persistance and biological activity of soil of insecticidal proteins from Bacillus thuringiensis and of bacterial DNA bound on clays and humic acids. J Environ.Qual, vol 29: 691-705.
19. "Transgenic lines proven unstable" by Mae-Wan Ho, ISIS Report, 23 October 2003 www.i-sis.org.uk
20. Vanessa E. Prescott, Peter M. Campbell, Andrew Moore, Joerg Mattes, Marc E. Rothenberg, Paul S. Foster, T. J. V. Higgins, and Simon P. Hogan* , Transgenic _Expression of Bean -Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity, Journal of Agricultural and Food Chemistry, 2005, vol 53 (23), p 9023-9030.
21. Wrightsons submission to MAF on protocol for seed testing."Brassica Cross pollination", Dr Stewart Gowers, Forage Brassica breeder, Crop and Food Research.

PART TWO

In considering the application under the HSNO Act ERMA need to weigh up any claims made for the research and the research outputs to justify the trial. The context for this consideration must include cultural, economic and sustainability issues that are largely ignored in the application itself but are highly relevant to ERMA’s decision-making under the Act.


1) Community desire to protect GE-free production must be considered to be a cultural feature of the current national identity. This is true for tangata whenua as well as other New Zealanders, including new migrants from India, Japan, Korea and Europe.

The Royal Commission on Genetic Modification found that it was in the National interest to preserve options. This includes people being able to buy GE-free products, and farmers being able to grow GE-free products.

New Zealanders have made it clear they want to protect availability of clean, safe, GE-free, natural, and organic produce in this country.

A survey of public opinion in 2005 shows 65% of New Zealanders believe GE produce does NOT fit with New Zealand’s image for producing clean and healthy food. (Ref: Small, Bruce: “Genetic Engineering: New Zealand Public Attitudes 2001, 2003, 2005”; Proceedings of the Talking Biotechnology – Reflecting on Science in Society Conference, 2005, Wellington NZ. Published on CDRom).

Only 9% of New Zealanders agree that “Producing GE products fits with NZ’s clean green image”, whereas 66% of people disagree. “In all three time snapshots (2001, 2003, 2005) the vast majority of respondents did not agree that producing GE food fits with either NZ’s clean green image or the image of marketing health food” (Small, B 2005).

On October 26, 2005 The Rural News reported the findings of a national poll, conducted for the Sustainability Council, on public attitudes to GMOs. It showed rural and urban dwellers equally support the concept that New Zealand should remain a GM Free food producer.

The overall result was that 74.5% of New Zealanders would support the nation''s food production remaining GM Free.

Rural responses showed fractionally higher support at 75.5% while urban respondents were marginally lower at 74.1%. These August figures compare with 70.1% support when the same question was put two years earlier.

The August DigiPoll survey also reported that 79% New Zealanders would support the current policy of zero tolerance to GM contamination of seed imports. It further found 77% support for zero tolerance to GM contamination of crops in the field, once informed that this too is the current policy. Rural and urban support was again quite close - within 2% of the overall result. See http://www.ruralnews.co.nz/article.asp?channelid=141&articleid=10001

Because the GE Bt Brassicas being trialed would cause widespread contamination of conventional crops they cannot deliver the implied benefits because it is unacceptable and unethical to terminate the New Zealand Public’s preference to preserve the option to grow and buy GE-free food.

Though some research indicates acceptance of GE food can be driven by price and misinformation, the issue for evaluating the costs of this application is the effective denial of access to uncontaminated food if the trial had a commercial outcome.

In light of the consistency of response in all cultural sectors of Aoteroa New Zealand communities, ERMA cannot ethically consider allowing contamination and removal of choice as a basis for decision-making.


2)The application presents an economic risk and an opportunity-cost given the rejection of GE foods in international markets.


Though it is noted that the applicant makes no claims of commercial demand for the GE brassica being trialled, it is still important to note that any impression of market acceptance created by existing sales of GE foods may be a reflection of deceptive marketing rather than genuine and informed acceptance by consumers.

There is evidence that commercial interests and academic researchers are willing to use deception as a tool to ‘encourage’ acceptance of GE food in the real market and in research studies. Some studies (Knight, J. “Trust and Country Image” 2003), show that people’s behaviour can be influenced by the language used in questioning and by a false product-proposition, leading to behaviour that contradict people’s intentions. For example questioning in academic research includes offering hypothetical “GE Milk with superior heath benefits” to gauge appeal without also providing information on the known risks of gene-manipulated food to allow informed decision-making by respondents in the study.

New Zealand research also indicates GM crops like those developed by the applicant present an economic problem for this country.

A report in November 2003 study from Lincoln University shows that release of GM crops will have no financial benefit for producers. Professor Caroline Saunders from [the] agribusiness and economics research unit says GM food releases have not benefited producers anywhere in the world, and economic modelling shows the situation for New Zealand is no different. Saunders says producers will only benefit from GM crops when consumers demand them, and New Zealand producers do not have anything to gain from growing GM food. Saunders warns that any potential for increased productivity from GM crops would not lead to higher producer returns, saying it is better to have greater demand through shorter supply: http://onenews.nzoom.com/onenews_detail/ 0,1227,218948-1-7,00.html
The economic risks have also been identified by other governments
In June 2006 The Mercury, (Australia) reported Tasmania’s State Government desire
to maintain its freedom from GM technology or risk valuable agricultural exports. The Primary Industry Minister Mr Llewellyn told a Budget estimates hearing said he could not support coexistence between GM and traditional crops as it had major ramifications for Tasmania. "We are positioning Tasmania as GM-free and we don''t want to fall in with those who would target less-than discerning buyers," Mr Llewellyn said. Mr Llewellyn said the managing director of a major Japanese importer of Tasmanian products said if the state moved down the GM line, it would cut its ties with the state. see: http://www.GEinfo.org.nz/072006/09.html
In November2003 the UK Guardian newspaper revealed that the Canadian government had received Cabinet papers warning Canada off GM crops and exposing the threat to farmers and food exports. The risks included GE contamination of brassica crops.
The secret briefing to the Canadian government warned that the country''s massive food exports are at risk from its continued use of GM crops. The paper, which was drafted by a senior civil servant, and says that "producers are becoming worried about losing markets and losing choice over what they produce", while consumers are becoming more worried that they cannot distinguish between GM and non-GM products. "These concerns could precipitate a loss of confidence in the integrity of the Canadian food system, which could be very disruptive to the domestic system as well as Canada''s ability to export to demanding markets."
The Canadian Wheat Board has just surveyed its overseas customers in Europe, Japan and the US, with 82% saying that they would not take GM wheat. The export market for milling wheat into bread is worth £2bn a year to Canada.
Jim Robbins, a farmer and business consultant for the Canadian National Farmers Union said that large exports of oilseed rape had been lost to Europe as it was impossible to separate GM and conventional crops. In Canada, they had all been mixed together. Cross contamination, it said, was now "irreversible". Canadian farmers feared the same would happen with wheat, prompting a loss of exports and a crash in prices. see: http://www.guardian.co.uk/gmdebate/Story/0,2763,1083640,00.html#article

3) The Application Presents Risks for New Zealand’s international reputation and trade
There is no evidence of market appeal locally or internationally for any product the proposed field-trial will help develop. The Royal Society of NZ reported in November 2003 that New Zealand supermarkets are keen to be GE-Free
see : http://www.non-gm-farmers.com/news_details.asp?ID=829


In Australia - our closest major trading partner- the ABC (Science Online, 30.6.06) reports people are becoming more comfortable with new technologies like stem cell research but still have strong reservations about GM foods. A survey conducted by the Australian Centre for Emerging Technologies and Society asked Respondents about GM crops or animals and found them to be decidedly more negative than in 2004. Only 30% said they were comfortable with GM plants for food. The survey also found that just 18% of people were comfortable with genetically modifying animals for food. Source: www.GEinfo.org.nz/072006/02.html


As reported by Reuters News in June 2006, most Europeans - not just the British or French, believe that GM foods should not be encouraged and see biotech crops as posing a risk to society, a survey, conducted by a group of academics [for] the European Commission''s polling arm Eurobarometer, showed. 25,000 EU citizens polled in nearly all the bloc''s 25 countries remained sceptical about biotech used in agriculture. The Survey found “Europeans think GM food should not be encouraged, it is widely seen as not being useful, as morally unacceptable and as a risk for society.”see: www.GEinfo.org.nz/072006/01.html

In Eastern Europe consumer rejection of GM food is also growing. Around 76 per cent of Polish consumers said they didn''t want to eat any food containing GM ingredients, according to a PBS opinion poll commissioned by Greenpeace. The news follows an earlier study by Russia''s largest public opinion research body, VCIOM, that 95 per cent of Russians aware of GM ingredients said they were either opposed to them or seriously concerned by them. The surveys are an important sign that public opinion in Eastern Europe is moving towards the widespread GM scepticism already present in Western Europe.
see Foodnavigator.com, November 14, 2005 (EU) : http://www.GEinfo.org.nz/122005/04.html
In Asia opposition to biotech product like wheat is also steadfast. US Wheat Associates found in its survey of wheat buyers, millers and users that "there is currently an overwhelming rejection" of the biotech "Roundup Ready" wheat plant that Monsanto Co has developed.
The US Wheat Associates report found that all representatives for Chinese, Korean and Japanese wheat buyers surveyed said they would not buy or use Roundup Ready wheat.
One hundred percent of the Japanese users surveyed indicated that "regardless of government approval, contracts will stipulate no adventitious presence of GM wheat." In August, Italy''s biggest miller, Grandi Molini Italiani SpA, said it would refuse to import GM wheat or any wheat from countries where GM wheat is grown.
see Reuters, October 9, 2002 (USA): http://biz.yahoo.com/rc/021009/food_wheat_biotech_1.html


4) The application is at the cost of research into existing pest-management options and also presents a threat to Organic agriculture

In addition to issues like the loss of effectiveness of Bt used by organic growers raised in Part One of this submission, ERMA must also consider the impact of the trial on investment in other sustainable approaches to pest control and on the livelihoods of organic growers as a result of contamination.

Organic production is threatened both by lack of investment as an alternative to the trial, and by having its integrity destroyed because of the risk of contamination from failed containment measures, human error, natural vectors, and the prolific nature of brassica.

Overseas experience has shown GM crops threaten organics.
In May 2003 The UK Guardian newspaper reported UK environment minister Michael Meacher conceded that contamination from GM crops threatens organic food production. "The coexistence of organic and GM crops is a very real problem," he said. see: http://politics.guardian.co.uk/green/story/0,9061,959641,00.html
Organic farms have been contaminated already in the US

In May 2003 certified organic farmers reported the first direct financial and operational impacts associated with the threat of contamination by genetically modified organisms (GMOs) in a nationwide survey conducted by the Organic Farming Research Foundation (OFRF). One-third of the respondents rated the risk of exposure and contamination of their organic farm products by GMOs as high or very high. Said OFRF executive director Bob Scowcroft, "These new survey results based on the 2001 crop year document that significant impacts have begun to occur within a very short time frame. If this trend continues, what we''re seeing now will prove to be just the tip of the iceberg." OFRF president Ron Rosmann, a diversified organic farmer from Iowa said, "This new data supports OFRF''s call for a moratorium on GMO release until there is a solid regulatory framework that prevents genetic pollution and assigns liability for the damages imposed by contamination." The survey found that 8% of respondents indicated that their organic farm operation has borne some direct costs or damages related to the presence of GMOs. 17 percent have had GMO testing conducted on some portion of their organic farm seed, inputs or farm products. Of those, 11% said they received positive test results for contamination.
see: http://ens-news.com/ens/may2003/2003-05-15-09.asp#anchor1
The UK Commission Warned that GM crops will destroy farms

In April 2003 the a UK-based scientific commission revealed that cultivating genetically modified crops could devastate organic farming. In the light of new documents prepared by the Agriculture, Environment and Biotechnology Commission, more than 4,000 organic farmers nationwide could see their livelihoods endangered if their crops are contaminated by GM plants. The independent commission suggests that the spread of pollen from genetically modified crops means that certified produce would be forever tainted. "The effects of pollution are visible only after many years. That''s the case of the North American countries which have switched to GM and can no longer go back to organic." A spokesman said: "The AEBC is an independent body which analyses all data received on GM. It has been established to assess both the benefits and risks of the biotechnology." (Western Morning News, April 22, 2003 (UK Distributed by Financial Times Information Limited) see: http://hoovnews.hoovers.com/fp.asp?layout=displaynews&doc_id
=NR20030422670.4 _340a0021516204c6
Australian farmers have already been impacted by Brassica GM contamination from Modified Canola. In April 2003 a survey, commissioned by ICM Agribusiness in consultation with the Network of Concerned Farmers, found 70 per cent were worried, with fears including GM canola''s possible contamination of traditional crops. The poll found 71 per cent had concerns about the commercial release of GM canola, 67 per cent were worried about their ability to market the grain, while 80 per cent said they had fears about GM and non-GM canola co-existing. See Daily Telegraph April 10, 2003 (Australia): http://www.dailytelegraph.news.com.au/common/story_page/0,5936,6260267%255E704,00.html
The opportunity cost and extra costs to Farmers to stay GM-free must be included in any cost/ benefit analysis of the application
The European Commission has said that there is sufficient evidence that organic and conventional farmers will face extra costs keeping their produce "GM-free" once genetically modified crops become more common. A draft of the report by the EU''s Joint Research Centre estimated that costs for rapeseed farmers could increase by between 10 and 41 percent. see: http://www.agriculture.com/worldwide/IDS/
2002-05-17T144104Z_01_L1779050_RTRIDST_0_FOOD-EU-GENES.html

5) The history of contamination accidents is evidence for ERMA that risk management decisions must allow for failure in compliance with regulations designed to stop resistance (eg Refuges) or contamination.
In, April 2002 the Wall Street Journal reported that Monsanto Co. believes that some of its canola seed might contain genetically modified material that isn''t federally approved. Angling to avoid a massive recall of food products, the company is asking regulators to forgive any presence of it. The situation is potentially a big headache for the US food industry, because canola oil is a basic ingredient in hundreds of products. In conceding that for three years US farmers have been planting canola seed that may contain certain genetic material that was never meant to leave the laboratory, Monsanto has become the latest example of the biotechnology industry failing to control plants whose genes it has altered. Last year, the GT200 version showed up in Canadian canola seed, forcing Monsanto to recall hundreds of tons of it. Although Monsanto had sought and received Canadian approval for GT200, the recall was necessary because Canada exports huge amounts of canola to Japan, which hadn''t approved GT200. Monsanto says it never sold the GT200 version commercially in Canada and isn''t sure why it wound up in canola seed there.
see: http://www.connectotel.com/gmfood/ws150402.txt
Contamination problems overseas have shown segregation systems have failed and that unexpected gene-flow as well as major human error may be occurring and needs urgent investigation. Major contamination incidents to date include: spread of GE maize into natural crops in Mexico, contamination of conventional canola (a brassica) in Canada and Australia, contamination of US exports of Long grain rice by an experimental GE rice LL601 that was terminated five years before, contamination of human food by the Starlink corn variant approved only for animals because of its potential to cause allergies in people. In March 2005 Syngenta’s Bt10 corn was discovered in US exports of approved GM corn strain Bt-11.
See : http://www.ictsd.org/biores/05-07-22/story3.htm

Scientists have identified contamination risks in GM oil seed rape
The Guardian, October 14, 2003 (UK)

Government scientists have discovered that genetically modified oil seed rape cannot be contained by separating it from fields of conventional crops, after bees carried the pollen up to 16 miles (26km) away. A second piece of research has shown that once GM oil seed rape has been grown in a field, it would be 16 years before a conventional crop could be grown in the same field without fear of contamination of more than 0.9%, the threshold for claiming that the crop was GM free. The amount of gene flow rapidly declines over tens of meters and long distance transfer is "rare". Transfer from one field to the next is around 0.1%, one in 1,000. Long distance transfer was blamed on bees carrying the pollen back to the hive and swapping it with other pollen - fertilising plants thought to be miles out of reach. The scientists concluded: "Complete (100%) purity cannot be maintained by geographical separation." The second study involved the cross-pollination of rape with other wild relatives and spilt seed re-growing in fields the next year. Only rigorous spraying with weed killer every year for five years would reduce them to less than the 0.9% contamination level for the new crops to be classed as non-GM. If the field was not sprayed, the model predicted that the presence of the original variety in subsequent crops would not fall below 1% for 16 years. Web Link: http://politics.guardian.co.uk/green/story/0,9061,1062559,00.html


Field Trials have also been blamed for contamination in Australian Canola.
In November 2005 the ABC reported GM contamination has been traced to late 1990s trials.
Tasmania''s head of biosecurity welcomed an inquiry to determine exactly how GM canola contamination occurred. Contracted by the Victorian Government to grow a variety of canola in 1999, recent tests show that while the seeds were apparently GM-free, return shipments were contaminated. See www.abc.net.au/news/items/200511/1496141.htm?tasmania

Brassica trials in the UK show GM can impact fields for 15 years. In October 05 The Independent, (UK) reported government research showing GM crops contaminate the countryside for up to 15 years after harvesting. The study, published by the Royal Society, examined 5 sites across England and Scotland where GM oilseed rape has been cultivated, and found significant amounts of GM plants growing even after the sites had been returned to ordinary crops. The researchers found one plant per sq. m., 15 years after a single GM crop, enough to break the EC limit on GM contamination.


6) Insect Resistance will develop meaning the application is inherently limited in value
It is known that insects can rapidly develop resistance to single Cry genes in Bt plants.
‘Stacking’ multiple-Cry genes in Bt crops as suggested in the application can only be a short-term defence to slow resistance, before any benefit is lost. If this theory has merit it may warrant laboratory study but does not legitimate open field tests.
Similarly the known rate-of-failure amongst US farmers in maintaining refuges to slow resistance allow these risks to be calculated and included in any cost/benefit analysis


It is widely considered to be only a matter of time before resistance occurs in Bt-plants

Already some 17 insect species have become resistant to Bt in the laboratory, and one insect species shows widespread resistance in the field. (Glare & O’Callaghan 2000 sited in Tuelon and Losey 2002), (Andow 2002)

Though there is the suggestion made by scientists and supported by the applicants is to develop Bt plants with multiple ‘Cry’ protein toxin genes as a way to slow the resistance,

There is already evidence that resistance will still inevitably emerge, and bring to an end any short-term benefits of ‘gene stacking’ Bt toxins in GE plants.

Research (Tabashnik et al 1997) indicates just a single gene in Diamondback moths - one of the pest insect targeted in the field trials, confers multiple resistance to four different versions of Bt toxins. (see Tabashnik,B.E.,Y.B.Liu, N.Finson, L.Masson,and D.G.Heckel; “One Gene in Diamondback Moth ConfersResistance to Four Bacillus thurengiensis Toxins.” Proceedings of the National Acadamy of Sciences 94 (1997) 1640-1644)

See also www.hortnet.co.nz/publications/nzpps/journal/55/nzpp55_396.pdf
Dave Tuelon and John Losey (2002) Issues relating to the practical use of transgenic crops for insect pest management. NZ Plant Protection 55:396-404


7) The emergence of Secondary Pests from use of Bt crops requires ERMA also evaluate any claimed benefits in the application in light of risk management of complex and dynamic systems.

Very recent studies have revealed growing secondary pest populations have slowly eroded the benefits of Bt technology in China.

See: Tarnishing Silver Bullets: Bt Technology Adoption, Bounded Rationality and the Outbreak of Secondary Pest Infestations in China
Shenghui Wang, David R. Just Cornell University, Per Pinstrup-Andersen, H.E. Babcock
Selected Paper prepared for presentation at the American Agricultural Economics
Association Annual Meeting Long Beach, CA, July 22-26, 2006

The authors illustrate the effects of introducing Bt technology among farmers with an
imperfect knowledge of secondary pest problems using a simple dynamic model. The
stochastic dominance tests based on primary household data from 1999-2001 and 2004 in
China provide strong evidence that secondary pests, if unanticipated, could completely
erode all benefits from Bt cotton cultivation.
Though the researchers are more positive about data suggesting planting refuge concurrent with Bt adoption provides may help preserve Bt effectiveness it is necessary for Risk Management to recognize that actual farmer behaviour and human error erodes the reliability and longevity of such a refuge strategy and makes any benefit finite.

On pg 6 they write “ The emergence of a secondary pest in Bt cotton fields is by no means a random event. Rather, this emergence of secondary pests is a natural result of the use of Bt technology. Chemicals used to control bollworm have a relatively broad spectrum toxicity, unlike the narrowly targeted Bt toxin, and thus should kill many and varied pests. The use of Bt technology thus indirectly creates a safer environment for the growth of non-bollworm
pests. “This secondary pest effect has led to the “worldwide elevation of certain species
from relatively innocuous to highly destructive levels (Getz and Gutierrez p447).
Entomologists suggest it should take five to ten years for such a secondary pest
population to proliferate to a level that poses a significant economic threat. Field
experiments in China identify the potential damage from secondary pests after several
years of Bt use….While it is widely acknowledged that optimal pest management requires understanding the interaction between multiple pests (e.g. Getz and Gutierrez, Feder and Regev, Boggess , Harper and Zilberman), unfortunately, the Bt secondary pest effect has been at best underemphasized in the agricultural economic literature, and at worst completely ignored.”

Other reports on the study add:
“After 7 years of planting cotton genetically engineered to kill bollworms, other insects have boomed so much on Chinese farms that their owners are losing money….The researchers found that populations of other cotton pests, particularly ones called mirids, have blossomed. These were once killed by the same broad-spectrum pesticides used to control the bollworm. Now, farmers are spending almost as much on pesticides to control these secondary pests as those farmers growing regular cotton. Source: News@Nature.com Published online 25 July 2006, doi: 10.1038/news060724-5
“The study raises fears that explosions of secondary pests will also gradually erode the benefits of Bt cotton in other countries where it has been adopted, such as India and South Africa,'' said the report. China was the second country after the US to adopt Bt cotton in 1997.
After two to three years of use, studies had shown a dramatic rise in yield and 70 percent reduction in the use of insecticides. The current picture, however, is dismal. The researchers found the Bt cotton farmers have a net average income that is eight percent lower than farmers growing conventional cotton. IndiaeNews, July 27, 2006 (India/China).
see: http://www.GEinfo.org.nz/082006/02.html


8) Refuge-Management of BT crops cannot be adequately delivered in reality.
Use of ‘Refuges’ can only delay resistance but won’t stop spread of GE contamination

USDA survey shows some 20% of farmers of Bt corn were failing to adhere to the EPA’s refuge requirements aimed at slowing resistance.

See: Associated press, 10 Sept 03 http://www.GEinfo.org.nz/092003/08.html
USDA National Agricultural Statistics Service: http://www.usda.gov/nass
http://www.tallahassee.com/mld/tallahassee/news/politics/6739974.htm

Use of refuges and high-dose Bt plants proposed in the field trial may limit the speed of resistance but cannot prevent contamination of other crops, making the approach impractical as it unacceptably compromises standards of agricultural production necessary to protect the national interest.

“Determination of the size of refuges is a compromise between practical and commercial considerations which favour smaller refuges and scientific theory which favours larger refuges.(n Gould 2000, Shelton et al. 2000) The size of refuges is further complicated by some farmers failing to plant them at all (Anon.2001b).” (Tuelon and Losey 2002, p398)

The suggestion made on Radio NZ by Dr Mary Christey that these Bt brassicas will benefit home gardeners also contradicts the applicant’s written statement supporting the need for regulation of such crops if ever commercialized. Regimes to defend against resistance and contamination would be even more impractical for home gardeners than in commercial agriculture.

Scientist have warned the EPA that “50% refuge” is needed for some Bt crops.

In May 2003 Nature Biotechnology (USA) reported that the Environmental Protection Agency (EPA), which approved a new Bt corn in February, was at odds with its own scientific advisory panel over how to manage pest resistance to the crop. The unheeded scientific advice, and other decision-making glitches, left critics wondering whether EPA regulation is firmly grounded on the best scientific advice. "The EPA is calling for science-based regulation, but here that does not appear to be the case," says Scientific Advisory Panel (SAP) member David Andow, a corn entomologist at the University of Minnesota. Panel members convened by the EPA were mystified and frustrated when the agency bypassed some of their major recommendations. Other technical experts say they were asked to give their opinion on the corn, then blacklisted from the advisory panel later. The major disagreement, however, is the size of the transgenic crop ''refuge''. The SAP majority recommended a 50% refuge be planted, [ie] the same amount of non-transgenic corn must be planted beside or within transgenic crops. The EPA required a 20% refuge in the 3-year registration, the size Monsanto and another group of experts recommended.
see: http://www.nature.com/nbt/


9) Experience overseas indicates problems with Bt crops.
Toxic GE Crops have sometimes allowed insects to thrive.
Two research teams in England and Venezuela discovered something about the new GM crops filled with insecticide: insects not only eat them, they seem to thrive on them. Scientists at Imperial College in London and the Universidad Simon Rodrigues in Caracas found that the insects that the chemical additive was supposed to kill were not only feeding on the poison, but the stuff seems to help them thrive. 15.7.06
www.scoop.co.nz/stories/SC0607/S00025.htm
Monsanto also admits "numerous problems" with transgenic pest control. But as a result more sprays are set to be used.
In 2002 it was publicized that Monsanto''s patents admit transgenic pest control (as in Bt corn and Btcotton) "may not be desirable in the long term" because it produces
resistant strains and "numerous problems remain...under actual field
conditions". (see New Scientist August 17, 2002 Vol. 175; Pg. 22)
Novartis had already had doubts (New Scientist, 18 December 1999, p 5).
Monsanto will now bioengineer maize to release endotoxins, but also treat the maize seed
with the pesticides clothianidin and thiamethoxam. This, says Monsanto,
has a synergistic effect with the endotoxin, giving increased resistance
to corn rootworm.(Source: http://www.ngin.org.uk 19 August 2002)

Experience in India also indicates that Bt crops can result in increased use of toxic sprays because of secondary impacts on complex ecoystems.
In October 2002 The Hitavada (India) reported American bollworms had eaten more than 80% of the yield on a three acre farm, sown with Bt cotton seed
"The scale of attack forced us to spray insecticides. When Bt seed was introduced, its advocates said it would render pesticides obsolete," Dr Palarpawar said. "Farmers went for Bt as they were unable to bear the cost of insecticides. What''s the point in purchasing expensive Bt seed and also using equally expensive insecticides?" he asked. 2002 (India)
“At the Anandwan farm, the dreaded bollworm has emerged triumphant, deracinating what was projected to be its nemesis. Ironically, just beside the ruined Bt cotton crop stands a successful crop of Nanded 44 cotton, a domestically developed breed of cotton. This is no ordinary farm. It belongs to Anandwan College of Agriculture. The person crying foul is none other than the Dean of the College Dr. M Y Palarpawar. In September, the college staff had to clear the farm of 10,000 bolls left completely parched by the worms.” See: http://www.agbioindia.org/archive_m.asp?id=106&mo=10

The short-lived benefit of Bt crops has also been identified as a problem

In 2004 a study released by entomologists K Chandrasekar and G T Gujar at Indian Agricultural Research Institute in New Delhi cast doubts on the long-term benefits of Bt cotton. It found that the protection afforded by Bt gene is at best for six years - the bollworm develops "31-fold resistance to the toxin "cry1ac" within six generations." This means that cotton farmers may have to go back to spraying pesticides after six seasons unless scientists come out with Bt cotton hybrids that produce a high dose of the cry1ac toxin. The scientists say their findings "mandate the necessity of Bt resistance management." Development of resistance to Bt cotton is not unknown. In China the expected life of Bt cotton was found to be 7 to 10 years in areas under Bt cotton exceeding 70 per cent. Financial Express , February 10, 2004 (India) : http://www.financialexpress.com/fe_full_story.php?content_id=52355

Indian research showed resistance to Bt cotton developed in just 110 days
Based on a series of experiments, a team of scientists from Nagpur-based Central Institute of Cotton Research (CICR), proved that the Bt cotton became ineffective in its resistance to bollworm after 110 days. A team of scientists from CICR, led by Keshav R Kranthi, found that the resistant power in cotton plant remains only for 110days, after which the crop can be exposed to bollworm attacks.
“The Cry1Ac level declines as the plant grows and is found to drop below its "lethal level" of 1.9 mg within 110 days after sowing. The study was published in the July 25 edition of Current Science. Current Science also published in May 25, 2003, a similar study conducted by a team of scientists in the University of Agricultural Sciences, Dharwad. "The decline in resistant power means that the farmer has to apply more chemical pesticides to save his crop. Already, the cost of Bt cotton seeds are high and added to this, he incurs additional costs on pesticides. Eventually, he lands up in heavy debts," a researcher said. "Those farmers, who hope that Bt cotton can be a miracle and, therefore, do not apply heavy doses of chemical pesticides, are at a loss," said the director of Secunderabad-based Centre for Sustainable Agriculture (CSA), DrGV Ramanjaneyulu. "The very fact that scientists do not have control over toxin expression in plants shows that transgenic technology is imprecise and unpredictable," he said. He said that CSA conducted studies on each of the three years of commercial cultivation of Bt cotton in India. All the results proved that Bt cotton growers incurred losses. In contrast, the farmers growing non-Bt cotton, following the procedures of organic farming and applying bio-pesticides, reaped good profits, he said. ”See: Financial Express, August 01, 2005 http://www.financialexpress.com/fe_full_story.php?content_id=97943

US studies on GM cotton shows that although GM cotton can reduce pesticide use, it did not reduce use of herbicides nor did it improve biodiversity when compared to unmodified strains. Ecologist Yves Carriere of the University of Arizona, with his colleagues randomly selected 81 cotton fields - split between unmodified and transgenic cotton breeds. "You cannot simply assume that you will get across-the-board benefits," Carriere notes. "One thing I was a bit surprised to find is that if you control some pests with [transgenic] cotton, others become more of a problem." Scientific American, May 2, 2006 (USA) http://www.GEinfo.org.nz/082006/01.html



10) There is an ’opportunity-‘cost for the Bt crop research which has no commercial output: efforts can be better invested elsewhere.

Alternative research could deliver marketable products as well as scientific benefits that significantly exceed the approaches being developed by the applicants.
These may include, but are not limited to redirecting the investment from the proposed trial to Integrated Pest Management (IPM) and organic production systems.

Such approaches already offer solutions to the problems of chemical applications the applicants claim as the benefit of their research.

Organic farmers do not use organophosphates, carbamate and other insecticides or synthetic pyrethroids in New Zealand. Existing Integrated Pest Management (IPM) methods have led to a 50-65% reduction in total insecticide application to brassicas in New Zealand (Teulon and Losey, 2002). New Zealand has a strong history of successfully implementing IPM programmes with non-GE crops that which do not contaminate conventional food with GE constructs as Bt brassica crops will do.


ERMA must evaluate the costs of the project in this application against the benefits of clearly sustainable alternatives to Bt biotechnology products

The Union of Concerned Scientists writes: “When the goals include reducing dependence on pesticides and herbicides, there are clearly alternatives to many biotechnology products. Many of these alternatives are not other products, but instead the systems and methods of sustainable agriculture. Conversion from industrial agriculture to sustainable systems that depend less on chemicals would eliminate the need for many of the currently projected products of biotechnology. Agricultural biotechnology, as it is currently developing, is not particularly fruitful in the quest for a sustainable agriculture. Sustainable agriculture solves problems by understanding and adjusting the elements of the system to achieve its goals rather than by developing new products that must be purchased. Agricultural biotechnology, by contrast, is basically an input industry, developing products, often expensive products, priced to cover the costs of research and development. In sustainable agriculture, new products are less important than new knowledge and new ways of manipulating agricultural ecosystems:
http://www.ucsusa.org/food_and_environment/genetic_engineering/alternatives-to-genetic-engineering.html


11) ERMA must have access to and consider information from other experiments with Bt Broccoli that have been undertaken but which are not sited by the applicants and other peer-reviewed studies (listed in Weaver, Morris 2005)

*Cao.J, J.D.Tang, N.Strizhov, A.M Shelton and E.D.Earle, “ Transgenic Broccoli with high levels of Bacillus thuringiensis Cry1C Protein Control Diamondback Moth Larvae Resistant to Cry1A or Cry1C,” Molecular Breeding 5 (1999) 131-141

Gould.F, “ Sustainability of Transgenic Insecticide Cultivars: Integrating pest genetics and ecology,” Annual Review of Entomology 43 (1998) 701-726

Tabashnik B.E, Y.B Liu, n. Finson, l. Massson, and DG Heckel, “One Gene in Diamondback Moth Confers Resistance to Four Bacillus thuringiensis Toxins”, Proceedings of the National Academy of Sciencies 94 (1997), 1640-1644



12) The significant differences between Bt Plants and other Bt bio-pesticides must not be ignored. Fully contained research is required before a field trial application can be properly assessed


Bt plants produce much more toxin and for longer periods than other applications so their impacts cannot be expected to be the same.

There are also significant differences in risk associated with the nature of the recombined genetic elements and molecular changes occurring in transgenic plants.

“The transgenic Bt genes have been substantially modified. They are truncated and engineered to produce 100 times higher expression in plants (Hilder and Boulter 1999: Andow 2002). Significantly, many Bt genes in transgenic crops are modified so that they are toxic without need for proteolytic activation in the insect gut, (Groot & Dicke 2001). The ubiquitous and continuous availability of these highly expressed toxins in Bt-plants has important implications for their use in the field, ( and) necessitates new risk management techniques to take these differences into account( Jepson et al 1994). (Quoted from Teulon and Losey, 2002)



13) There is evidence that Bt plants can present new risks to natural predators and beneficial insects like bees, though data is lacking.

The absence of data “may be partly due to the inability of current risk assessment procedures to adequately address the complexity of ecosytems. (Obrycki et al. 2001; Hilbeck 2002)” ( Teulon and Losey 2002, page 398)

It is wrong for the applicant to claim “Therefore Bt crops are not adding anything new to the already existing flow of cry genes among soil micro-organisms” (page 27)

Though the applicant states research associated with the trial will test for Horizontal Gene transfer this research is more suitable for fully contained studies, not open field trials.

The applicant is also wrong to ignore concerns about HGT of antibiotic resistant marker genes (NPTII resistant to kanamycin) in people or animals consuming the Bt crops. At the same time they dismiss concerns about HGT in soil, stating “the NPTII gene DNA will not alter or disturb a soil ecosystem”.


14) Decisions by overseas regulators on the safety of GE food cannot be considered reliable data to inform ERMA’s Risk Management evaluation.

There is a growing body of evidence that Regulatory approval of existing GE crops produced overseas has been seriously flawed.

The applicant makes reference to overseas approval of a range of biotechnology products as evidence of the safety and value of its own field trial, but this is implication is unsound.

ERMA cannot consider past “case by case” approvals of genetically engineered Bt crops for consumption in New Zealand / Australia or overseas as proof of safety or legitimate data for risk management purposes.


The US FDA ignored the warnings of its own scientist when it declared GE foods are ‘substantially equivalent’ to conventional foods.
The FDA put in place food rules that assume unforeseen effects will occur and, therefore no safety testing is required, for genetically engineered foods. This premise has been proven wrong. (see: Physicians and Scientist for Responsible Genetics: Submission to Councils, April 2006)
The Center for Science in the Public Interest, a Washington group known for a moderate stance on the use of genetic engineering to alter food plants, contends that the Food and Drug Administration, the primary federal agency responsible for food safety, missed "obvious errors" in reviewing some gene-altered crops. "Had FDA conducted thorough reviews, the errors would have been easily detected," they said. The group said the FDA''s procedures are so full of holes that continued safety cannot be ensured as companies press to bring many more GE plants to market. "The companies don''t provide enough data to prove these foods are safe," said Gregory A. Jaffe, director of biotechnology issues at the center. "And FDA''s review process doesn''t give you a lot of comfort that they''ve looked at it closely and challenged the companies." Some gene-altered food plants fall under regulations requiring mandatory approval from the Environmental Protection Agency before going to market. But others fall solely under the FDA''s food-safety jurisdiction, and that agency has adopted only voluntary procedures for companies to follow. In many instances the FDA requested information on the nutritional composition of a plant that industry failed to provide.
see: http://www.washingtonpost.com/wp-dyn/articles/A19370-2003Jan6.html


Experts are warning that GE foods previously approved must be tested using new techniques.
In 2006 agricultural economist Dr Charles Benbrook – a former advisor to the Carter, Reagan and Clinton administrations- warned of serious concerns over safety in respect of genetically engineered foods. He says these crops should be retested using Australian food safety technology developed by the Australian National University.
(See: Canberra News Bureau, Rural Press Agricultural Publishing: “ GM crops: US expert wants crops e-tested with latest technology,” by Michael Thomson, 30 November 2005)

The tests were used to identify problems with the decade-long project by CSIRO already discussed in Part One of this submission. The aim was to develop genetically modified peas with built-in pest-resistance. The tests showed the GM pea caused allergic lung damage in mice and the project was abandoned. (see 21.11.05 NewScientist.com )

Australian regulation of GE food is also inadequate

In April 2006 West Australian Agriculture Minister Kim Chance said the national food safety watchdog (Food Standards Australia New Zealand), does not adequately assess health impacts of GM crops. "[It] is not rigorous. They review information sent to them by GM companies, the review is fairly superficial and they don''t look at the raw data," Mr Chance said. A new trial, due to start mid-year, will see laboratory rats or mice fed GM and non-GM crops over a six month period. Their blood and organs will then be analysed to see if there is any significant difference between those fed different crops. West Australian, April 10, 2006 (Australia)
see: http://www.non-gm-farmers.com/news_details.asp?ID=2711

The European Union has also approved GM crops despite scientific warnings
The European Commission approved a range of GM foods and crops despite having serious doubts over their health and environmental impacts, according to green charities. Greenpeace and Friends of the Earth said documents revealed scientific arguments put forward behind closed doors in the EC''s recent GM trade dispute. The Commission argues that there were "large areas of uncertainty about the health risks posed by GM produce," and that "some issues have not yet been studied at all." The papers also say "there simply is no way of ascertaining whether the introduction of GM products has had any other effect on human health," and "no unique, absolute, scientific cut off threshold available to decide whether a GM product is safe or not." The documents [also] suggested there were huge disagreements between the Commission and the European Food Safety Authority, the agency that is responsible for GM risk assessments. The Daily Telegraph, April 18, 2006 (EU) see: http://www.telegraph.co.uk/news/main.jhtml?xml=/news/
2006/04/18/ugm.xml&sSheet=/portal/2006/04/18/ixportaltop.html

In April 05 EU Environment Commissioner Stavros Dimas attacked the EU''s top food safety agency for flawed risk assessments of GM crops and foods, saying it relied too much on data given by the biotech industry. "EFSA cannot give sound scientific opinion on long-term effects of GMOs. There are also questions on whether GMO companies are providing the right information to the Commission."
see: http://www.planetark.com/dailynewsstory.cfm/newsid/35913/story.htm

In July 05 The European Commission was found guilty of withholding information on GM food. The Ombudsman charged the commission with "maladministration" after it refused to disclose documents to environmental pressure group Friends of the Earth. The documents revealed scientific concerns about the long-term health safety of genetically-modified foods.

The EU has been found guilty of withholding GM food data
Dow Jones News Service, July 19, 2006 (EU) http://www.GEinfo.org.nz/082006/08.html

Overseas Regulation of field trials and commercial release are also unreliable as the basis for ERMA’s Risk Management assessment

A two year safety audit by the United States Office of the Inspector General found that “Current (USDA) regulations, policies and procedures do not go far enough to ensure the safe introduction of agricultural biotechnology”.

The U.S. Department of Agriculture has failed to properly oversee field trials of genetically engineered crops, including plants designed to produce chemicals for medical and industrial uses, investigators say. A report released Thursday by the USDA''s inspector general said the department "lacks basic information”.
(source: DesMoinsRegister.com December 30, 2005 accessed 11 November 2006 ID: des2005123011458778 )

The Associated Press, (USA) (July 23, 2004) writes:
“The US Department of Agriculture has shifted from being a people''s agency to an agency for corporate agriculture, a new report by a coalition of agriculture leaders charges.
The report, titled, "USDA Inc.: How Agribusiness has hijacked regulatory policy at the US Department of Agriculture," was commissioned by the Agribusiness Accountability Initiative, a network of family farm and public interest groups. The report calls the USDA "one of the strongest proponents" of GM foods, even though many farmers have been vehement in their opposition. The report charges that the USDA support can be directly attributed to top-ranking USDA officials having ties to biotechnology companies." These industry-linked appointees have helped to implement policies that undermine the regulatory mission of USDA in favor of the bottom-line interests of a few economically powerful companies," the report states: http://www.aberdeennews.com/mld/aberdeennews/news/9227760.htm


A Pew Report also highlights questions over biotech regulation
The Pew Initiative on Food and Biotechnology released a lengthy report on the US review process for future biotech food products. Th[e ensuing] debate cuts across the usual industry versus consumer lines, with some regulators and industry officials privately conceding that the current system is - if not broken - at least in need of preventive maintenance. The existing regulatory framework was assembled during the Reagan administrations from a patchwork of existing laws and regulations and given to USDA, FDA and EPA to administer in a coordinated fashion. The report acknowledges that current ag biotech products have been widely adopted without evidence of food safety or environmental problems. However, it said "the potential complexity of future products may challenge the ability of the existing Coordinated Framework for Regulation of Biotechnology to continue to protect public health and the environment and maintain public trust."
see: http://news.bbc.co.uk/1/hi/sci/tech/3584763.stm

15) ERMA must consider the lack of research into GM health effects. There is inadequate laboratory data available to justify the trials proposed in the application

A study by scientists in Norway and Denmark shows a serious lack of published research into the health effects of GMOs. The study, published in the journal Nutrition and Health says that there have only been ten published studies of the health effects of GM food or feed. Over half were undertaken fully or partially in collaboration with companies, and these found no negative effects on body organs. The other studies were independent and looked more closely at the effects on the gut lining. Several of these found potentially negative changes which have not been explained. The biotechnology companies often refer to some 100 animal feeding studies as proof of safety. [But] these were designed to test the commercial value of the animal feed, not safety. Many of these studies were duplicates and not all were published.
Medical News Today, June 24, 2004 http://www.medicalnewstoday.com/medicalnews.php?newsid=9876

ERMA must consider the serious concerns about the hazards of GE Foods, including use of antibiotic resistant markers

The use of antibiotic resistant marker genes is a negative risk factor that has prompted the British Medical Association as long ago as 1998 to call for the end of such uses.

Antibiotic resistance in GE crops proposed by the applicant may be adding to the problem and increasing risk.

In 2000 German scientists discovered that antibiotic resistant markers (ARM) genes from engineered canola were transferring their resistance to the bacteria found in guts of bees that had consumed pollen form plants.

European Union studies revealed ARM genes in GE foods could transfer into bacteria in the human gut as well as soil bacteria.
Source: www.organicconsumers.org/ge/genemarker.cfm


"The spread of antibiotic resistance is the main threat from gene transfer from
GM crops," said Joe Cummins, Ph.D., professor emeritus of genetics at the
University of Western Ontario, Canada. "I have found that the antibiotics
used in GM crops are used in surgery and to treat a number of diseases."
(Source: http://www.organicconsumers.org/ge/genemarker.cfm)

Survival of DNA in the human gut has now been proven
Weaver and Morris (Journal of Agricultural Environmental Ethics, 2005, 576) identify:
“the first recorded confirmation in the scientific literature that fragments of the tDNA can be transferred to gut bacteria in the human gut. There is some indication that transgenic DNA is more readily transferred to gut bacteria than non-transgenic DNA from the same plant”
(Netherwood T., S.Martin-Orue, A.G.O’Donnell, S.Gockling, J.Graham,J.c.Mathers and H.J.Gilbert; “Assessing the Survival of Transgenic Plant DNA in the Human Gastro intestinal Tract”, Nature Biotechnology 22 ( 2004), 204-209)

If genetic material from antibiotic-resistant marker genes can also find its way into the human stomach, as experiments at Newcastle university suggest is likely, then people''s resistance to widely used antibiotics could be compromised. The research, commissioned by the food standards agency, is the world''s first known trial of GM foods on human volunteers.
They found "to their surprise" that "a relatively large proportion of genetically modified DNA survived the passage through the small bowel". In three of the seven samples they found bacteria had taken up the herbicide-resistant gene from the GM food at a very low level.
Michael Antonio, a senior lecturer in molecular genetics at King''s College Medical School, London, last night said that the work was significant. "To my knowledge they have demonstrated clearly that you can get GM plant DNA in the gut bacteria. Everyone used to deny that this was possible." The Guardian, July 17, 2002 (UK)
http://www.guardian.co.uk/gmdebate/Story/0,2763,756666,00.html


The British Medical Association has also called for further studies on GM foods.
A BMA report calls for more long term research into the potential of GM food to cause allergies, although it acknowledges that preliminary, short term studies of GM foods have not shown any health risks. It says that more research is also needed on the impact of GM foods in vulnerable groups, such as babies, elderly people, and people with chronic diseases, and that the health effects generally of GM foods should be closely monitored. Dr Vivienne Nathanson, BMA Head of Science said "The current absence of any evidence suggesting GM foods pose a threat to human health should not lead to complacency. Public health surveillance should be so complete that we can be certain that adverse effects from any dietary change would be recognised. We also need a commitment to research in key areas to minimise the potential risks to human health and the environment posed by genetically modified food."
British Medical Journal, 2004;328:602, March 13, 2004 (UK): http://bmj.bmjjournals.com/cgi/content/full/328/7440/602-a




The use of the Cauliflower Mosaic Virus (CaMV ) promoter sequence presents risks and demands research prior to ERMA considering this application

The 35S CaMV promoter has been shown to potentially activate genes in mammalian species, and may even be a cancer risk

“The (Genetic Engineering) tool includes a "promoter," virtually always a gene from the Cauliflower Mosaic Virus, to allow the new genes to work within the host organism. Organisms normally repress, or "silence" new genes: The presence of the Cauliflower Mosaic Virus makes this defense less effective. Geneticist Cummins said he fears this promoter gene could recombine with other genes (bacteria and dormant viruses) to create new pathogens that could be harmful or lethal to plants, animals or people.”
(Source: http://www.organicconsumers.org/ge/genemarker.cfm)


The 35S CaMV plant virus promoter has been shown to be active in human enterocyte-like cells.

An investigation into the promoter capacity of 35S in human enterocyte-like cells demonstrated that the 35S CaMV promoter was able to drive the expression of both reporter genes to significant levels, although the protein expression levels might seem modest compared to those obtained with the strong promoters derived from human cytomegalo virus (hCMV) and simian virus 40 (SV40). Some of the identified motifs indicate that transcriptional activation by the 35S CaMV promoter may be stronger in other human and animal cell types than in those investigated.European Food Research and Technology, October 20, 2005 (Online). Research News: http://www.GEinfo.org.nz/122005/07.html


A recent paper by Dr.Terje Traavik and Dr. Jack Heinemann ( http://www.biosafety-info.net/file_dir/719762120455431f1a3942.pdf ) takes a critical look at the state of scientific knowledge about the potential human health effects of genetic engineering and genetically engineered organisms. The authors identify some of the putative health hazards related to genetically engineered plants used as food or feed. They also identify numerous areas of omitted research, which need urgent investigation. This includes risks related to rearrangements of transgene inserts, the fate and consequences of DNA persistence and uptake in the mammalian gastro-intestinal tract, alteration in protein contents of GM food, the allergenicity of transgenic products, the implications of post-translational modifications and questions over the 35S CaMV promoter and the use of antibiotic resistance marker genes.


People living near GE crops have also reported health effects.

Scientists investigating a spate of illnesses among people living close to GM maize fields in the Philippines believe that the crop may have triggered fevers, respiratory illnesses and skin reactions. If preliminary results are confirmed, it would be one of the first recorded cases of serious health problems associated with GM crops, and could damage the reputation of the biotech agriculture industry, which is rapidly expanding in developing countries.
Terje Traavik, scientific director of the Norwegian Institute of Gene Ecology, was asked to investigate. Blood tests showed the villagers had developed antibodies to the maize''s inbuilt pesticide. Professor Traavik, who issued a summary of his results yesterday, said more tests were needed, but felt his preliminary findings were reliable. His studies suggest that a virus promoter - which is like a motor driving the production of the genetic message - was unexpectedly found intact in human cells. His team also said it had found that genetically engineered viruses used in the GM process recombined with natural viruses to create new hybrid viruses with unpredictable characteristics. If confirmed, this could suggest that they could cause new diseases. http://www.guardian.co.uk/gmdebate/Story/0,2763,1157222,00.html

See also: RI Vazquez Padron et al (1999) Intragastric and intraperitoneal administration of Cry1Ac protoxin from Bacillus thuringiensis induces systemic and mucosal antibody responses in mice. Life Sciences, 64, 1897-1912.
Impact of Bt Cotton on Farmers’ Health (in Barwani and Dhar District of Madhya Pradesh) Investigation Report, Oct - Dec 2005, www.GMWatch_org.htm
Mortality in Sheep Flocks after grazing on Bt Cotton fields, – Warangal District, Andhra Pradesh,Report of the Preliminary Assessment, April, 2006 www.GMWatch_org.htm
Chowdhury EH, Kuribara H, Hino A, Sultana P, Mikami O, Shimada N, Guruge KS, Saito M, Nakajima Y. Detection of corn intrinsic and recombinant DNA fragments and Cry1Ab protein in the gastrointestinal contents of pigs fed Genetically modified corn Bt11. J. Animal Science 2003, 81, 2546-51
Vanessa E. Prescott, Peter M. Campbell, Andrew Moore, Joerg Mattes, Marc E. Rothenberg, Paul S. Foster, T. J. V. Higgins, and Simon P. Hogan* , Transgenic __Expression of Bean -Amylase Inhibitor in Peas Results in Altered Structure and Immunogenicity, Journal of Agricultural and Food Chemistry, 2005, vol 53 (23), p 9023-9030.

16) Further research is required into impacts of Bt crops on soil ecosystems and animals before the application can be considered and a cost/benefit assessment properly made.


ERMA must consider the impact of the field trial and its outcomes on native and other insects, particularly beneficial insects important for pollination and honey producers
A study by Crop & Food Research is monitoring the behaviour of native flies in arable plants and has found they could be major pollinators.

The skills of native flies in pollinating South Island crops may shed more light in evaluating the potential of cross contamination from genetically modified plants. "If New Zealand was ever to allow commercial transgenic crops we must first examine any possibility of gene flow from these crops to other crops, weeds and native flora," said Crop & Food Research entomologist Dr Brad Howlett.
Little was known about the role of native pollinators in transferring pollen in crops before this study. Until now it was assumed bees do most of the crop pollination and arable farmers have traditionally placed honey bee hives next to crops for this purpose.
Native flies have, however, been found in some crops carrying up to 19,000 pollen grains - as many as honey bees. On crops of pak choi, a bibionid fly was found in numbers 10 times more than honey bees and carrying the same amount of pollen.
The range of pollinators in crops, however, varies widely even on sites that are close together. In Central Otago it was found that two onion fields about 17km apart attracted completely different ranges of insects.
"To evaluate the likelihood of the movement of transgenic genes via pollen from GM plants, we must first understand the mechanisms that cause pollen movement," said Howlett.
The Press, October 7, 2005 (New Zealand): http://www.GEinfo.org.nz/102005/06.html


Further research is needed into the death of Sheep Grazing on Bt Cotton to inform an adequate risk assessment by ERMA

In May 06 at least 1 800 sheep were reported dead from severe toxicity after grazing on Bt post-harvest cotton fields in just four villages in Andhra Pradesh India
The symptoms and post-mortem findings strongly suggest they
died from severe toxicity. This latest report confirms the findings of an earlier fact-finding investigation, on illnesses in cotton farm workers and handlers caused by Bt cotton in another cotton-growing state, Madhya Pradesh, in India. Similar illnesses and deaths among villagers in the Philippines linked to exposure to Bt maize since 2003. Similar Bt toxins from the soil bacterium Bacillus thuringiensis incorporated in GE crops are involved in all cases; but the regulators have done nothing.

The techniques used in genetic engineering are known to have the potential to have unexpected effects. The application before ERMA makes no mention of pleiotropic effects, that is, unexpected side effects of a genetic change. Saxena and Stotzky (2001) studied Bt corn which had been genetically modified to produce the cry1Ab protein to kill lepidopteran pests. The Bt corn ended up having very much higher levels of lignin, a pleiotropic effect.

High levels of lignin are associated with disease resistance to insect and microbial pests, so this looked positive. However animals feeding on grasses or corn with high lignin content utilize the food inefficiently. (Saxena, D and Stotzky, G. (2001). Bt corn has a higher lignin
content than non-Bt corn. American Journal of Botany 88:1704-1706).


The implications of detection of GM DNA fragments and Cry1Ab protein in gastrointestinal contents of pigs also need to be assessed for risk management

GM corn has been approved as an animal feed in several countries, but information about the fate of GM DNA and protein in vivo is insufficient. The rsearchers examined the presence of corn intrinsic and recombinant cry1Ab gene by PCR, and the Cry1Ab protein by immunological tests in the gastrointestinal contents of five genetically modified corn Bt11-fed and five non GM corn-fed pigs. Fragments of recombinant cry1Ab gene (110 bp and 437 bp) were detected in the gastrointestinal contents of the Bt11-fed pigs but not in the control pigs. These results suggest that ingested corn DNA and Cry1Ab protein were not totally degraded in the gastrointestinal tract, as shown by their presence in a form detectable by PCR or immunological tests. Journal of Animal Science 81:2546-2551, 2003 : http://jas.fass.org/cgi/content/abstract/81/10/2546

ERMA must consider the impacts on soil and other organisms of this trial.
Persistence of higher-levels of Bt toxins in soil surrounding Bt raises concerns for impacts on other microflora and fauna

Research has shown that the toxin released in root exudates accumulates in soil as it adsorbs and binds rapidly on surface-active particles (e.g. clay and humic substances) and retains insecticidal activity for at least six months (Saxena et al.,2002). (Weaver, Morris 2005)

Further contained research in the laboratory is appropriate but does not require open-field trials of a Bt Brassica crops that can have no commercial application.


Risk assessment must consider research showing "Bt toxin is released in root exudates from12 transgenic corn hybrids representing three transformation events"

The anti-lepidopteran toxin (Cry1Ab protein) encoded by truncated genes from Bacillus thuringiensis was released in the root exudates from all hybrids of Bt corn studied and which represented three transformation events (Bt11, MON810, and 176).
In vitro and in situ studies indicated that the toxin released in root exudates accumulates in soil, as it adsorbs and binds rapidly on surface-active particles (e.g. clays and humic substances), and retains insecticidal activity for at least 180 d, the longest time studied.
The results indicated that the release of the Cry1Ab protein by roots is a common phenomenon with transgenic Bt corn and is not restricted to only the one Bt corn hybrid (NK4640Bt) and tranformation event (Bt11) studied initially.
D. Saxenaa, S. Floresb and G. Stotzky Soil & Biology
Biochemistry Vol. 34 pp 133-137
Soil & Biology Biochemistry, January 2, 2002 Full item: http://www.GEinfo.org.nz/042002/06.html
ttp://www.checkbiotech.org/root/index.cfm?fuseaction=subtopics&topic_id
=6&subtopic_id=26&doc_id=2733&start=1&control=108&page_start=1&
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