Crop and Food Application GMF06002

Submission to ERMA on Crop & Food Application GMF06002
Field test of genetically modified Alliums (onions, shallots, spring onions, leeks garlic) (Dr Colin Eady).

Person making submission:
Dr Elvira Dommisse BSc (Hons), PhD (Biotechnology), Mus.B, LTCL, AIRMTNZ - submitting on behalf of Soil & Health Inc (NZ) and Physicians and Scientists for Responsible Genetics, PSRG (NZ).

Employed by DSIR/Crop & Food Research Institute (1985-1993), during which time I set up the GE onion programme.

I ask that ERMA decline this application

I ask to speak to this submission

Purpose of GE Allium field trial

Hundreds of cultivars of onions, garlic, and leeks are grown around the world today. These vary greatly in flavour, colour, sweetness, pungency, dry matter, keeping qualities and disease and drought resistance. There is such a vast pool of genetic diversity in Allium crops today that new cultivars of onions, leeks and garlic with desired characteristics can be bred using conventional techniques, sped up by DNA marker-assisted selection.

The question about this application that needs to be asked is this. Why has so much R & D capital been spent on the genetic engineering of Alliums for no tangible benefit and why field-test them when there is no actual or potential market for them?
Biosafety issues have be poorly researched or in some cases not researched at all in this application. Recently published research demonstrates that there are still many unanswered questions (Traavik and Heinemann, 2007) and it is the reponsibility of this Allium field trial application to be addressing those questions.

Current poor performance of glyphosate-tolerant GE onions (GMF03001) at Lincoln

The GE Roundup-tolerant onions that have been grown by Lincoln Crop & Food in a field test since 2003 have performed poorly. (ERMA report on GMF03001 GE onions). They have been infested by thrips and shown susceptibility to soft rot diseases. This is an indication that the GE onions are genetically and phenotypically inferior to their non-GE counterparts.

GE onion yields have in fact been so poor that Crop & Food have resorted to importing GE onion seed from a USA seed company (ERMA Report on GMF03001 GE onions), thought to be Seminis, which is now owned by Monsanto. Given that the crops were not grown in New Zealand and the seed/germplasm was not produced in NZ conditions, this has defeated the purpose of the field trial under NZ conditions. It has turned into a data gathering exercise for a US seed company.

Genetic engineering of Alliums for “health benefits”

Crop & Food would like to field test Alliums engineered with transgenes intended to make them “healthier” (Summary, p. 1, par. 3). Why? Garlic is currently regarded as a superfood. It has anti-bacteial, anti-fungal and anti-viral properties, reduces the risk of stomach and colon cancers, lowers cholesterol, thins the blood and may help prevent high blood pressure, heart disease and stroke (Lister, 2003, Yeager, 1998)

Onions are also noted for their health-giving properties. They have been shown to help raise beneficial cholesterol, lower blood pressure, decrease the risk of cancer, relieve congestion and reduce inflammation. They are a rich source of potent antioxidants known as flavonoids. One flavonoid produced by onions, quercetin, is particularly effective against heart disease (Yeager, 1998).

Genetic engineering of food crops with transgenes coding for beneficial or benign proteins has resulted in compounds being produced that cause cellular, organ, blood or immunological abnormalities in laboratory animals (potatoes - Ewen and Puzstai, 1998; peas - Prescott et al., 2005; soybeans - Malatesta, 2002, 2003 and Vecchio et al., 2004; a range of crops as reviewed in Pryme and Lembcke, 2003).

By way of background, rats fed on GE potato developed precancerous cell growth in the digestive tract, inhibited development of their brains, livers, and testicles, partial atrophy of the liver, enlarged pancreases and intestines, and immune system damage (Puzstai, 2002). Disruption to functional DNA is inevitable in the genetic engineering process and results in disruption to cellular pathways. Novel compounds, hitherto unheard of can be formed in GE plant cells (Schubert, 2002).

Before considering a field trial, the GE Alliums should first be fed to lab animals for food safety experiments. This should be a minimum requirement in ERMA’s assessment of all GE food crops.

Phenotypic variation within the onion species sufficient for conventional breeding

There are hundreds of onion cultivars, differing in day-length requirement, skin color (white, brown, yellow, red, or purple), size (1-6 in or 2.5-15.2 cm in diameter), shape (globe-shaped, flattened or spindle-shaped), pungency and sweetness. Both pungency and sweetness (which are not mutually exclusive) are determined to a considerable extent by the chemical characteristics of the soil in which the onion is grown (www.floridata.com/ref/A/alli_cepa.cfm). Genetic engineering is not required to introduce these characteristics into the species.

Escape of GE Pollen

Onions and leeks are suited to the climate of Canterbury and have been grown in the Lincoln region for many years. They will also be grown and allowed to flower in many vegetable gardens and quite probably some commercial plots in the area.

Although cages will be in place to prevent insect movement from the flowers, pollen could still escape from infloresences, resulting in the contamination of other onions grown in the region. Pollen does not stop being wind-borne at exactly 1000m (p.35, par. 3) from the GE onion plot. Letting onion/seed growers know after planting has occurred is incredibly short sighted and will be too late for those growers. Any contamination via GE pollen could result in their losing money.

Crop & Food also grow non-GE onions to flowering each year as part of their breeding programme. These could potentially be contaminated by wind-borne pollen. Pollen that has escaped from the flowering Alliums could easily be carried by the wind. Just because Alliums are not primarily wind pollinated (p. 14, point 4) does not mean that this will not occur.

Potential GE contamination of honey

Bees forage on onion flowers. Crop & Food onion breeders bring in beehives in each year at flowering time to help cross-pollination of the onion flowers and there are other hives in the area. If these bees were to get access to GE pollen, they would return to the hives and it would end up contaminating honey. GE-contaminated honey is the last thing that local apiarists need, with the current threat of varroa mite hanging over them. GE-contaminated honey could potentially destroy our honey export industry.

GE seed, bulbs and cloves in/on soils

When I worked on onions at Crop & Food I kept onion seeds in cool storage. They can be viable for years when kept cool. The application says that all Allium seeds would be viable for less than three weeks during the autumn/winter period (p.15. point 2)? This is not necessarily true and would depend on the weather.

Similarly, garlic cloves and onion and leek bulbs/bulbils may possibly persist within the soil under normal Canterbury climatic conditions for more than 8 months without breaking dormancy (p.15, point 5). Although unlikely, it is possible.

Dubious justifications for testing outside as opposed to in containment

‘Quality’ traits (Summary, p.1, par.3) can be assessed in containment. The seed company Pacific Seeds www.pacificseeds.com grows lines of corn and other crops that may have a percentage of inadvertant GE contamination in containment. They test each plant by leaf DNA tests and bulk up seeds from non-GE, healthy plants.

To say that the GE Alliums must be grown in the field, because “within PC2 glasshouse facilities it is difficult due to disease pressure, space requirements...” (p.30 par.7) shows Crop & Food’s lack of investment in facilities that ensure biosafety with respect to GE crops. Either that or it’s a poor excuse by the applicant.

Further to this, the applicant says, “several valuable research proposals…will be severely compromised if the application cannot proceed” (p.60, point 4). It is not ERMA’s job to assess the commercial deals that may or may not lie ahead. They assess the application on the grounds of environmental risks. This sort of statement is emotional manipulation.

It is dubious to say that “this trial will enhance the international reputation of NZ agricultural research” (p.60, point3), given that most countries in the world do not grow large acreages of GE crops. Europe and Japan, two of the most important destinations of NZ onion exports, grow very little in the way of GE crops and public opposition to GE foods is strong in these countries.

“The knowledge gained regarding environmental impacts and agronomic performance will help society and the community to decide whether or not to use GM technology….” (p.60, point 5) assumes there is a need for this technology. Certified organic growers are managing to grow onions, garlic and leeks of the highest export quality without GE technology or synthetic chemicals. There continues to be a high demand for these crops, both locally and internationally.

On p. 60 (point 7) of the application there is mention of the “development of…elite germplasm”. Elite Allium germplasm grown in the field is of no use, unless it has been deemed safe to eat and until it has been tested as safe to eat, it cannot be called “elite”.
The most outrageous claim made by the applicant is that “GM crops may be the subject of international fair trade concerns” (p.60, point 4). Fair Trade organisations worldwide have unanimously expressed their disapproval of GE crops, both in terms of the enormous social costs and biosafety (food and environmnetal). To date hundreds of thousand of farmers in India have committed suicides after the failure of their Bt cotton crops. Such crops were heavily promoted by Mahyco-Monsanto and the seed was sold for up to four times the price of local non-GE cotton cultivars http://www.grain.org/seedling/?id=457 and http://tinyurl.com/y7anj8 (Bt cotton performance reports).
By contrast, producers of of organic cotton surveyed over a period of two years (60 organic and 60 conventional farms) by an Indo-Swiss research team benefited from
40% lower costs for inputs, 13-20% lower variable production costs, a far lower need to take up loans, total labour inputs that were not significantly higher and 4-6% higher average cotton yields. There is now a rapidly expanding international market for organic cotton - with even the likes of Wal-Mart and Levis getting in on the act.
http://www.businessweek.com/innovate/content/sep2006/id20060927_111136.htm?chan=innovation_innovation+%2B+design_innovation+and+design+lead

No public benefits

There are no credible public benefits to this trial. Instead, a US seed company’s dirty work is being done here (Appendix 1, title page) and NZ is left with the consequences of GE contamination, be it in the soil via HGT or in the germplasm of Alliums. If anything comes of it, the seed company might commercialise the GE Alliums. That may be an advantage to them, but it’s of no advantage to New Zealand. We as taxpayers will be left with the bill to clean up genetic pollution, to pay for the costs this expensive research and to pay for the ERMA application/submission costs.

In the week beginning 28 January 2008, Colin Eady was interviewed on National Radio (Noelle McCarthy) on the topic of tear-free onions (‘Afternoons’ www.radionz.co.nz). In this interview he more or less said the following:

The tear-free onions are still very much in the development phase and there are no plans for growing them outdoors. The knowledge of this gene could possibly be used to breed a tear-free onion conventionally.

Two questions need asking at this point. Firstly, why field-test an onion that is very much in the development phase? Field-testing is the precursor to commercial growing or at least commercial field trials. If your GE crop is very much in the development phase, it is not ready to be field-tested.

Secondly, if no market has been identified as being interested in such GE Alliums, why field trial them? Such work could only result in a scientific dead end.

Inducing flowering by genetic engineering

Flowering can be induced in onions by vernalization (cold treatment) of plants (p.13, point 8). Why then does one need to induce flowering by GE? The risks do not outweigh the benefits of something so easily achieved without GE. It is also a lot cheaper and quicker to vernalize than to genetically engineer.
Horizontal Gene Transfer (HGT) of transgenic DNA to soil micro-organisms
The application claims that the risk of horizontal gene transfer (HGT) is negligible, based on ESR studies (p. 26, par. 3) and one 1998 publication in a science journal. The ESR studies and 1998 paper are based on assumptions and methodologies that have since been discredited (Heinemann and Traavik, 2004; Lerat et al., 2005; Lerat et al., 2007; Babic et al., 2008). Quoting an out of date reference and an outdated E&R report shows that the applicant is not acquainted with the current scientific literature on HGT, an area very relevant to GE field trials.

Research has shown that recombinant DNA from GE crops does persist in soil and even spreads to nearby fields by natural processes (Lerat et al., 2007). The presence of the recombinant CP4 EPSPS gene from RoundupReady (RR) corn and RR soybean was quantified using real-time PCR in soil samples from a field experiment growing RR and conventional corn and soybean in rotation. RR corn and RR soybean CP4 EPSPS persisted in soil for up to 1 year after seeding.

HGT will be occurring during such a field test and lack of detection of HGT should not be a confirmation of its absence. Growers in the vicinty should be aware of this finding because their soil may be contaminated with GE DNA from this and other field trials at Lincoln.

A recent publication (Heinemann and Traavik, 2004) demonstrates that using the fastest known DNA sequencing technology, it would take all 6 billion people on this planet, working in parallel, 30 thousand years to properly demonstrate no transgene transfer from transgenic crops to just soil bacteria (much less all the other organisms in the environment). I think we can safely say that this kind of experiment has not been done considering that the fastest DNA sequencing technology is only 3 years old.

The key criticism about the HGT comments is very little and very selective citation of research. Recent up-to-date articles show the application is poorly researched. Crop & Food should be forced to say what their limits of HGT detection are and whether those limits are relevant to capturing gene transfers that can result in environmental damage.

There is no experimental detail given on the intended HGT work. Therefore no assessment of this application can possibly be made and the work cannot be validated.

Kanamycin and other antibiotic resistant marker genes

Antibiotic resistant marker (ARM) genes are not the only way to confirm that a transgene has been inserted. Although ARM genes are the easiest way, there are risks associated with this. In the USA, FDA scientists warned against the use of ARM genes as early as 1993 (http://www.fda.gov/fdac/features/795_antibio.html).

Glyphosate Toxicity

In 2003, Crop&Food Research applied to ERMA to field test its GE Roundup resistant onion. The application stated that this was a sustainable way in which to grow onions as glyphosate is ‘essentially non toxic to mammals’ and ‘environmentally friendly’.

This application states that glyphosate tolerance will once again be engineered into Alliums. Glyphosate tolerance is the most common trait to be engineered into GE crops worldwide, supposedly because glyphosate (Roundup) is a relatively benign herbicide. However, recent research has shown that glyphosate is much more harmful than was first thought.

Glyphosate is toxic to human placental cells within 18 hours at concentrations lower than those used agriculturally. This toxic effect increases with concentration, time of exposure and in the presence of Roundup additives (Richard et al., 2005).

Studies have shown that Roundup, the second most commonly used herbicide in the United States, is extremely lethal to amphibians (Relyea, 2005a; 2005b; 2005c). These field experiments comprised one of the most extensive studies on the effects of pesticides on non-target organisms in a natural setting and the results may provide a key link to global amphibian population declines. Incidentally, Monsanto, the US seed company thought to be involved in this proposed field trial, have tried to discredit the published work of Relyea on their website.

Increased glyphosate residues present in GE foods, e.g., GE soy, are thought to be contributing to increased allergies to soy (Benbrook, 2004). In fact, the symptoms identified in a UK soy allergy study are among those related to glyphosate exposure. The allergy study identified irritable bowel syndrome, digestion problems, chronic fatigue, headaches, lethargy, and skin complaints including acne and eczema (Townsend, 1999). Symptoms of glyphosate exposure include nausea, headaches, lethargy, skin rashes, and burning or itchy skin (Cox, 2004). It is also possible that glyphosate’s breakdown product, AMPA, which accumulates in GE soybeans (Duke et al., 2003; Sandermann, 2006) might contribute to allergies.

Claims of sustainability and reduced herbicide use

In Appendix 3 (p.5, 6.1,6.2) there are claims of herbicide tolerant onions leading to “more sustainable…. production” and GE plants being safer through “reduced pesticide usage”. The applicant has not cited a comprehensive, long- term study published in 2004, which documents increased use of herbicides and pesticides on GE crops (compared with non-GE crops) in the US over a nine-year period (Benbrook, 2004).

Economic costs

By the time this ten-year trial is finished the GE onion work will have gone on in Crop & Food for 30 years. The total cost for these 30 years will be well into the millions, with no high performing, commercially viable cultivars at the end. In 30 years an onion breeder could have come up with a few very good commercial cultivars by using classical and DNA marker-assisted (non-GE) breeding techniques. These would be readily accepted, grown and eaten by the public and the plant variety rights would generate revenue for Crop & Food.

Organic and non-GE crops command a premium that GE crops cannot command. Tegel (NZ), for example, has a policy of using only non-GE chicken feed. They use Identity Preservation to ensure this is the case. This costs them more than if they were to include GE corn or soy in the feed (Mark Wright, Tegel, Levin, pers. comm.). Similarly many NZ food industry giants, including Goodman Fielder, George Weston, Griffins, Heinz Watties, Sanitarium and Sealord have a non-GE ingredient policy (www.gefreefood.org.nz). Steinlager (Lion Nathan) currently has an advertisement on television that takes a negative view of genetic engineering.

If GE onions are to be a crop of the future, one would hope that there was at least a potential market for them. Because the application has no information on the potential end use/s of the crops, apart from getting the dirty work of a US seed company done here, the whole trial is set to become a costly data gathering exercise of no economic benefit to NZ.

General food and biosafety concerns of GE crops

Concerns about Agrobacterium-mediated transformation of plants have not been addressed in this application.

These include the following:

a. Mutations usually occur near the insertion site (J. R. Latham, et al., 2005)
b. Insertions commonly end up disrupting known gene sequences (J. R. Latham, et al., 2005).
c. Growing a crop from tissue culture can create hundreds or thousands of mutations throughout the DNA, creating differences in an estimated 2%-4% of the DNA, according to two studies (Bao et al., 1996; Labra et al., 2001)
d. One study demonstrated that up to 5% of the genes tested changed their levels of RNA expression when a single gene was inserted (Srivastava, et al, 1999).
e. The location of the transgene insertion may, according to the FDA, lead to "higher levels of toxins than normal, or lower levels of a significant nutrient" (U.S. FDA, Premarket notice concerning bioengineered foods: Proposed rule)
f. The promoter sequence inserted into plant to switch on the transgene may also inadvertently permanently turn on a native plant gene.

The head of the Salk Institute’s Cellular and Neurobiology Lab in the US, D David Schubert, contends that GE crops are not sufficiently monitored by the U.S. Food and Drug Administration (FDA) to ensure safety (2005). The paper says that contrary to popular belief the FDA has not formally approved a single GE crop as safe for human consumption. Instead, at the end of the consultation, the FDA merely issues a short note summarizing the review process and a letter that conveys the crop developer’s assurances that the crop is substantially equivalent to its conventional counterpart.

Substantial equivalence, as referred to on p. 61 of the application will not detect any toxic novel compounds produced by the transgenic Alliums. It will only confirm the total amounts of known onion constituents, e.g. sugars, sulphur compounds and colour compounds.

In another publication Schubert (2002) summarizes concerns held by scientists worldwide about the introduction of new genes into crops by genetic engineering. These include three essential issues at the cellular level.

(a) The introduction of the same gene into two different types of cells can produce two very distinct proteins (demonstrated in the work on peas by Prescott et al., 2005).

(b) The introduction of any gene, whether from a different or even the same species, usually significantly changes overall gene expression (what gets produced in a cell as a result of the genes present), thereby changing the biochemical characteristics of the recipient cell.

(c) Introduced genes coding for enzyme pathways, which synthesize small molecules, such as vitamins, could interact with existing pathways in the cell to produce new molecules.

The potential consequences of all of these changes could be the biosynthesis of molecules that are toxic, allergenic or carcinogenic.

A 2003 review documented all animal feeding studies that had been published in scientific journals up until that time (Pryme and Lembcke, 2003). None of the industry-funded studies reported adverse effects of GE crops on lab rodents. All of the independent studies reported some kind of adverse effect.

In 2006 the World Health Organisation issued a report calling for further safety assessments on GE foods. The report warns, "...some of the genes used to manufacture GE foods have not been in the food chain before and the introduction of new genes may cause changes in the existing genetic make-up of the crop. Therefore, the potential human health effects of new GE foods should always be assessed before they are grown and marketed, and long-term monitoring must be carried out to catch any possible adverse effects early." This confirms the need for rat-feeding studies to first be carried out prior to field-testing of Alliums

Problems with use of antisense DNA in transgenic crop plants

The application states that antisense DNA will be engineered into Alliums (p.20, par.3). In the 1990s, the first GE food in the US, the Flavr Savr tomato, was engineered with antisense DNA to stay firm so that it would have a longer shelf life. Flavr Savr was approved by government officials against the advice of its own FDA scientists, who were concerned about unexplained stomach lesions in mice fed on the tomato. The mice, normally content to eat tomatoes, refused to eat the GE tomatoes, so were force-fed through gastric tubes and stomach washes. Seven out of forty mice died within two weeks. The tomato was approved without further tests (www.biointegrity.org). They were, however, not popular with the public, who said they had an unpleasant taste. With this result in mind, it would seem essential to carry out rat feeding experiments prior to field-testing.

Use of CaMV35S promoter

The application states (p.18, par.4) that the same vector systems as used for the GE onions GMF03001 will be used. This includes the use of the cauliflower mosaic promoter CaMV35S, a promoter that has genes switched on all the time producing large amounts of transgenic protein/s. In 2005, results from experiments with rats fed on GE food were released at the UN Cartagena Protocol for Biosafety Meeting. The cauliflower mosaic virus promoter, a DNA segment used in most GE crops to switch on the transgene, was found intact in rat tissues two hours, six hours and even three days after it was mixed into a single meal.

Prof. David Williams (This email address is being protected from spambots. You need JavaScript enabled to view it.), a New Zealand academic working in the field of medical genetic engineering (UCSD School of Medicine, California) says, “a promoter should be more selective. It is unnecessary to have the RR or Bt genes expressed all the time and in all tissues. Why not just express the Bt gene at the time(s) of pest attack and in only the parts that the pest attacks? Similarly, with the EPSPS (Roundup tolerance) gene, why not express it just at the time of Roundup application (Monsanto states that one application at one time should be enough, although we all know what they expect - and hope). I don't know enough about how Roundup works, but maybe the gene also only needs to be expressed in the foliage and not in the root. Perhaps you could clarify this latter point for me - for instance, with the onion, could you avoid expressing the RR gene in the bulb, and still have it be resistant?

So, by selecting expression in time and/or location, it seems to me that you could avoid having the transgenic product in food.

In order not to have transgene expression at the time of harvest, or at any time in the parts we eat, something other than a constitutively active viral promoter (CaMV35S) is needed. The best choice would be a promoter from a gene that is expressed normally in that species - at the right time and place. So, for the onion, use the promoter of an onion gene. When the question was turned back to me at the (2003) hearing, I just about said that if you don't know of a suitable onion gene, you have no business monkeying around making GEOs from onions. Of course it takes a bit of work to "promoter bash", and thus define the promoter region of a gene, so hence the resistance to do it - why bother when you can get the marketplace to accept something cruder and cheaper to make?”

Control plants, rotations and conditions in the field trial

On page 37 (point 9) of the application it says, “null segregants used as control plants are still classed as transgenic…” Why are transgenic plants used as controls? This is not a valid scientific experiment, as a field trial compares the performance of transgenic plants to their (truly) non-transgenic parent lines.

The GE Alliums will also be grown on the same soil as GE brassicas (p.33, par 1). This will confuse any work done on HGT and DNA in the rhizosphere, as there will be two different sources of transgenic DNA. In addition, why is the GE brassica field trial grown on the same land as the GE Allium field trial. Are they not separate field trials?

Disposal of transgenic field trial material

On page 37 (point 8) of the application it says, “if large numbers of bulbs are not required (e.g. excess bulbs from large plot trials) these may be composted…within the field site.”
Such composting shows no regard for the fact that GE DNA persists in the soil. This has been clearly demonstrated (Lerat et al., 2007). Scientists also agree that HGT is inevitable, but not always detected (Heinemann and Traavik, 2004; Babic et al., 2008).

One can only assume that the applicant is blissfully unaware of this or that he thinks that it doesn’t matter, because the contamination of soils with GE DNA via HGT has already occurred.

Lack of scientific detail on environmental impacts and biosafety research

The application (page 9, par 3) says that environmental impact research is being undertaken by “a multi-disciplinary team of scientists from university and CRI organisations”. There is no detail given about who is doing this work and what they are doing. How do we know if anything is happening at all? Where are the publications from these scientists? Are those carrying out the work experts in the fields of work they will be doing?

The application has overlooked interactions between GE proteins produced from two or more different transgenes inserted into the same crop. To treat two separate transgenic proteins being produced in large quantities as fully independent and non-interactive is to extend reductionism science into dangerous territory.

Many environmental factors are overlooked in this application. Environmental factors have a huge impact on gene expression, and yet assessments are not being carried out on a range of growing conditions. Experts and organizations worlwide agree that environmental influences on GE crops need more attention. Not only does transgene expression vary greatly, but the impact of some mutations might not become apparent until the crop is grown under the specific conditions that normally trigger the gene.

This application lacks scrutiny and is very lightly referenced, with many bold statements not referring to any prior research or, at best, referring to one outdated paper that is many years old. The reference list contains a reference to a poster paper, which is not peer-reviewed and cannot be looked up to refer to. Many of the references are from books, which are often not peer-reviewed.

Summary

There is sufficient genetic diversity within the Allium species to provide good traits that can be conventionally bred into existing Allium cultivars. This can be sped up with DNA marker-assisted selection. Genetic engineering of food crops often results in these crops being toxic, carcinogenic or allergenic and thus less safe than their non-GE counterparts. Only rat feeding studies done prior to field-testing would confirm whether they are worth field-testing. Dr Eady said publicly that “tearfree” onions (altered sulphur pathways) were in the early stages of development, which means they are not ready for field-testing.

The CaMV35S promoter and antibiotic resistance markers (e.g.KanR) are only used in outdated vectors. The risks arising from the use of outdated vectors (presumably used because they involve less work) outweigh any benefits that might result from this trial.

Science has moved rapidly in the area of HGT in the last 10 years. The risks of contamination of soil microorganisms or Allium germplasm with transgenic DNA are real and do not outweigh any hypothetical benefits of seeing how these Alliums might perform in the field. If existing GE onion field trials are anything to go by, the performance of the GE Alliums will be poor.

This application has insufficient experimental detail for it to be seriously assessed. ERMA should acknowledge this and require a more scientifically up to date research proposal and more background research, particularly on the topic of biosafety (food and environmental).

Finally, it is not up to a submitter to prove to ERMA that this application is flawed, but up to Crop & Food to prove that their proposed field-test is safe. They have not provided enough scientific evidence for this to be the case.

References

Babic, A. et al (2008). Direct visualization of horizontal gene transfer. Science 319:1533

Bao, P.H., Granata, S., Castiglione, S., Wang, G., Giordani, C., Cuzzoni, E., Damiani, G., Bandi, C., Datta, S.K., Potrykus, I., Callegarin, A. and Sala, F (1996). Evidence for genomic changes in transgenic rice (Oryza sativa L.) recovered from protoplasts. Transgen Res 5: 97-103.

Benbrook, C. Genetically engineered crops and pesticide use in the United States: The First Nine Years. October 2004.

Cox, C. (2004) Herbicide fact sheet: glyphosate. J.Pest. Reform 24, no. 4.

Domingo, J. L. (2000). Health Risks of GM Foods: Many Opinions but Few Data. Science 228:1748.

Duke, S.O. et al., (2003). Isoflavone, glyphosate and aminomethylphosphonic acid levels in seeds of glyphosate-treated, glyphosate-resistant soybean. J. Agric. Food Chem. 51: 340–344.

Ewen, S.W.B. and Puzstai, A. (1999). Effects of diets containing GM potatoes expressing Galanthus nivalis lectin on small rat intestine. The Lancet 354:1353-1354.

Heinemann, J.A. and Traavik, T. (2004). Problems in monitoring horizontal gene transfer in field trials of transgenic plants. Nat. Biotechnol. 22:1105-1109.

Labra, M., Savini, C., Bracale, M., Pelucchi, N., Colombo, L., Bardini, M. and Sala, F. (2001). Genomic changes in transgenic rice (Oryza sativa L.) plants produced by infecting calli with Agrobacterium tumefaciens. Plant Cell Rep 20: 325-330.

Latham, J.R. et al., "The Mutational Consequences of Plant Transformation," The Journal of Biomedicine and Biotechnology, 2006, Article ID 25376: 1-7; see also John Innes Centre, "Study G02002-Methods for the analysis of GM wheat and barley seed for unexpected consequences of the transgene insertion," September 2001 to January 2005.

Lerat, S., Gulden, R.H , Hart, M.M, Powell, J.R , England, L.S., Pauls, P., Swanton, C.J
Klironomos, J.N. and Trevors, J.T (2007). Quantification and Persistence of Recombinant DNA of Roundup Ready Corn and Soybean in Rotation. J. Agric. Food Chem. 55 (25):10226-10231.
Lerat et al. (2005). Real-time polymerase chain reaction quantification of the transgenes for Roundup Ready corn and Roundup Ready soybean in soil samples. J. Agric. Food. Chem. 53: 1337-1342.
Lister, C. (2003). Antioxidants – a health revolution. NZ Institute for Crop & Food Research Ltd

Malatesta, M. et al., (2002). Ultrastructural analysis of pancreatic acinar cells from mice fed on genetically modified soybean. J. Anat. 201(5): 409.

Malatesta, M. et al., (2003). Fine structural analyses of pancreatic acinar cell nuclei from mice fed on GM soybean. Eur. J. Histochem. 47: 385-388.

Prescott, V.E., Campbell, P.M., Moore, A. Mattes, J., Rothenberg, M.E.,
Foster, P.S. Higgins, T.J.V and Hogan, S.P (2005). Transgenic Expression of
Bean-Amylase Inhibitor in Peas Results in Altered Structure and
Immunogenicity. Agric. Food Chem. 53 (23): 9023-9030, 2005.

Pryme, I. and Lembcke, R. (2003). In vivo studies on possible health consequences of GM food and feed – with particular regard to ingredients consisting of GM plant materials. Nutrition and Health 17:1-8.
Pusztai, A. (2002) Can science give us the tools for recognizing possible health risks of GM food? Nutrition and Health, 2002, Vol 16 pp73-84
Relyea, R.A. (2005a). The impact of insecticides and herbicides on the biodiversity and productivity of aquatic communities. Ecological Applications 15:618-627.
Relyea, R.A. (2005b). The lethal impacts of Roundup and predatory stress on six species of North American tadpoles. Archives of Environmental Contamination and Toxicology 48:351-357.
Relyea, R.A. (2005c). The lethal impact of Roundup® on aquatic and terrestrial amphibians. Ecological Applications 15:1118-1124.
Richard et al. (2005). Environmental Health Perspectives 113: 716-720.

Sandermann, H. Plant biotechnology: ecological case studies on herbicide resistance. Trends in Plant Sci. 11, no. 7 (Jul 2006): 324–328.

Schubert, D. (2002). A different perspective on GM food. Nat Biotechnol 20:969, 2002

Schubert, D (2005). Regulatory regimes for transgenic crops. Nat Biotechnol 23: 785-787

Srivastava, et al., Pharmacogenomics of the cystic fibrosis transmembrane conductance regulator (CFTR) and the cystic fibrosis drug CPX using genome microarray analysis," Mol Med. 5, no. 11(Nov 1999): 753-67.

Townsend, M. Why soya is a hidden destroyer. Daily Express, Mar 12, 1999.

Traavik, T. and Heinemann, J. (2007). Genetic Engineering and Omitted Health Research: Still No Answers to Ageing Questions, TWN Biotechnology & Biosafety Series 7.

U.S. FDA. Premarket notice concerning bioengineered foods: Proposed rule, Federal Register 66:4706-38. http://www.cfsan.fda.gov/~lrd/fr010118.html

Vecchio, L., Cisterna, B., Malatesta, A., Martin, T.E., and Biggiogera, M. (2004). Ultrastructural Analysis of Testes from Mice Fed on Genetically Modified Soybean. European Journal of Histochemistry 48 (4): 449-454.

Yeager, S. (1998). The doctor’s book of food remedies. Rodale Press Inc.

Information

Providing scientific & medical information & analysis in the service of the public's right to be independently informed on issues relating to human & environmental health.