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20 April 2000

Re: The proposed decision to add Chardon LL (Aventis -T25 Maize) to the National List.

Written representations pursuant to and expressive of a desire to be heard for the purpose of Regulation 21 of the Seeds (National List of Varieties), Regulations 1982

Introduction

Representation is made by Dr Mae-Wan Ho and Angela Ryan from the Institute of Science in Society (I-SIS), c/o Department of Biological Sciences, Open University, UK, to object to the proposed decision to add Chardon LL (Aventis –T25 Maize) to the National List.

ISIS is a not-for-profit organisation whose aims are to promote socially responsible science, science for sustainability and the integration of science in society. We also represent a group of scientists around the world (currently ) who are extremely concerned over the actual and potential hazards of genetic engineering biotechnology which have emerged in recent scientific findings. The scientists have co-signed a World Scientists Statement and several Open Letters to All Governments, calling for a moratorium on environmental releases of genetic-engineered organisms and products on grounds that they are unsafe, and to revoke and ban patents on life-forms and living processes, on grounds that they are unethical (Appendix 1).

Mae-Wan Ho is Reader in Biology at the Open University, with more than 30 years of experience in research and teaching across several disciplines from biochemistry, molecular genetics to biophysics, with over 200 publications including 10 books. She has been scientific advisor and major spokesperson of the Third World Network on Biotechnology, Biosafety and related issues since 1994. Angela Ryan is a graduate in molecular biology of King’s College, London who has joined ISIS as research assistant and the Open University as honorary research fellow since Jan. 1999. We have produced many reports and papers on biosafety for policy-makers and the general public, as well as articles for peer-reviewed scientific journals. Our latest scientific papers raise serious concerns over the safety of the CaMV promoter used in practically all transgenic crops already released commercially or undergoing field trials (including Aventis’ Chardon LL), and recommend that all GM crops containing the CaMV 35S promoter must be withdrawn immediately from commercial production or open field trials (Appendix 2). This is in accordance with the precautionary principle, on which the Cartegena Biosafety Protocol is based.

Objections

Our objections are based on the following: 1. The initial EU approval for Chardon LL is unlawful according to the EU’s own regulations. 2. The data submitted by the company fail in important respects to satisfy international agreements on safety of GMOs already reached on the Biosafety Protocol and the Codex Alimentarius Commission of the WHO. 3. The transgenic insert contains hazardous DNA. 4. The tests conducted by the company fail to address impacts on health and biodiversity.

There is sufficient scientific evidence of actual and potential hazards arising from transgenic crops such as Aventis Chardon LL T25 for it to be withdrawn from release altogether, especially in accordance with the precautionary principle which is now internationally accepted as the basis of the Biosafety Protocol. It would be irresponsible to add Aventis Chardon LL T25 to the National list.

1. Unlawful according to EU regulations

Agrevo (now Aventis) applied through France for EU marketing approval for T25 type maize in 1996 and was given approval in 1998 under The EU Deliberate Release Directive (90/220/EEC). T25 can therefore be grown anywhere in the EU without notifying governments or the public. It may also be imported as grain from outside the EU and has been used for animal feed and may also have been used in human foods. But this is actually illegal.

All GM foods sold in the EU must meet the requirements of the Novel Foods Regulation (258/97). Aventis’s T25 was approved by the ‘fast track’ route, whereby a full safety assessment was not necessary and the company simply notified the Commission of its intention to place the maize on the market. However, this route of approval is meant to be an exception that applies only to foods derived from GMOs which do not contain any genetically modified DNA or protein - such as highly processed oils. Therefore, only the products of T25 that do not contain any genetically modified DNA or protein - such as oil, actually have approval under the EU Novel Foods regulation (258/97). Aventis must therefore file a new application for approval of the whole grain. This would require a full safety assessment at the EU level. At present T25 maize is being illegally used in animal feed and in human foods.

Aventis only has an experimental licence to use glufosinate on farm scale trails. Glufosinate does not have approval from the Pesticides Safety Directorate at the Ministry of Agriculture, Fisheries and Food. Therefore, it cannot be used legally on commercial crops in this country.

In 1996 the UK government advisers, the Advisory Committee on Releases to the Environment (ACRE) stated that they were "satisfied the T25 did not pose a risk to human health and the environment". However, only one person on the committee at that time had any expertise in animal health. Since EU approval was granted in 1998, the EU Deliberate Release Directive has undergone some major revisions, which include a substantial increase in the rigour of risk assessments required before approval for the marketing of a GM crops. Applicants are now required to address indirect and delayed effects of release; delayed effects on animal health and consequences for the food/feed chain; impacts on the soil and soil nutrient cycling; immediate, delayed, direct and indirect impacts of changes in agricultural practice brought about as a result of the release of the GM crop. Moreover, any application for GM marketing approval must now include a monitoring plan in order to pick up any unexpected impacts on the environmental from the release of the GM crop. Aventis’ T25 Maize had been approved without assessment of any of the parameters listed, nor was there post-release monitoring for unexpected impacts

In a declaration of the EU Council of Ministers in Dec 1998, it was stated that the changes to risk assessment were so important that they should be applied immediately, even before the revised EU Directive comes into force. Since the new regime has been put in place no GM crops have been given EU marketing approval and all applicants must meet these more rigorous requirements. In April 1999, the Minister for the Environment - Michael Meacher, announced that he was widening the remit and membership of ACRE in order to take into account the widened requirements at the EU level. However, the new ACRE committee has never considered Aventis’ T25 maize.

Chardon LL is a fodder maize and is fed directly to animals, mainly cattle, rather than being grown for grain. There is no formal procedure for assessing the safety of GM animal feed. MAFF have commissioned a preliminary scientific study to assess the safety of GM animal feed which concluded that GM material should not be used for silage and GM animal feed requires heating to 95 degrees for at least 5 minutes in order to fully degrade the transgenic DNA (see appendix 3). Despite this, ACRE states in a report to the Welsh Assembly that T25 is intended for use in silage. The EU has recognised that there is no evidence available regarding the effects of feeding T25 fodder maize to cattle. The UK government recently appointed the Advisory Committee on Animal Feeding Stuffs (ACAF) but it has not considered T25 maize. In Dec 1999 ACAF stated that "feeding trials carried out with mongastrics would not be directly applicable to ruminants". The Director of the Centre for Veterinary Medicine at the US Department of Health and Human services said " unlike the human diet, a single plant product may constitute a significant proportion of the animal diet. Therefore, a change in nutrient or toxicant composition that is considered insignificant for human consumption may be a very significant change in the animal diet." Maize makes up to 30 -50% of the diet of cattle and is being used more and more as it is a cheaper alternative to grain.

2. Inadequacies of data submitted

More than 130 nations including the UK have agreed to adopt the precautionary principle as the basis of the International Biosafety Protocol in Montreal in January 2000. Subsequently, the Codex Alimentarius’ Intergovernmental Task Force on Foods Derived from Biotechnology agreed at its meeting in Chiba in March 2000 to prepare procedures and requirements for the approval of GM foods that are on par with those used to regulate prescription drugs. These include long term monitoring for adverse health impacts and tests for genetic stability, toxins, allergens and other unexpected effects. Traceability is a key issue. Technical labeling and record keeping mechanisms will keep track of all GM foods from field to plate, so that any GM product can be readily removed from the market if problems arise.

The first inadequacy of the data submitted by Aventis is that the molecular genetics characterisation supplied do not enable anyone to identify and trace the transgenic line unambiguously; and give no guarantee that the line submitted for approval is genetically (as well as phenotypically) stable or uniform. (Actually no real data of any kind are contained in the submission, perhaps they are in appendices which are withheld as commercially sensitive information. This is already unacceptable in terms of public health and safety.) The lack of relevant molecular genetics data is especially serious. Each transgenic line is the result of one or more transformation events in a single plant cell. On account of the uncontrollable, random nature of the transformation process, each transformed cell, and hence the transgenic line derived from it, will differ from all the rest, despite the fact that the same gene-construct and vector system are used. Moreover, transgenic lines are well-known to be unstable, and further genetic and epigenetic changes will often occur in successive generations during cultivation, so the properties of the plants in later generations will become quite different from the original approved line. This consideration is important, as it is stated in the Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T25), pursuant to Council Directive 90/220/EEC, "The consent shall cover any progeny derived from crosses of the product with any traditionally bred maize".

The instabilities of transgenic inserts include gene deletions, duplications and rearrangements as well as gene silencing and secondary mobility. When the original T25 line is backcrossed to the parental line or to other elite non-transgenic varieties, we can expect both pleiotropic effects due to epigenetic interactions in different genetic backgrounds and position effects, due to genetic rearrangements and secondary mobility, including random re-insertion into the genome.

In effect, blanket approval is being granted for what may be an unstable, non-uniform variety that is likely to undergo significant changes in qualities affecting safety in subsequent generations. We have provided some guidance to the molecular characterisation required as documentation of genetic stability and to aid identity preservation of transgenic lines (Appendix 4).

In Agrevo’s original submission (date received 3 June 1996), no entries are made under ‘Detection techniques’ (item 23a), ‘Genetic stability of the organism and factors affecting it’ (item 17) and ‘Description of detection techniques for GMO in the environment (item 40a), other than "Not relevant". This makes it impossible to identify the transgenic line for traceability. Traceability is not just a commercial, agronomic issue, it is also a safety issue, as for example, in case of contamination of organic crops by cross-pollination, or the creation of dangerous pathogens by horizontal gene transfer (see Objection 3 below).

In the description of the vector, substantial stretches of sequences are unaccounted for in terms of source or function as follows: 1 to 399, 1747-2164, 2714-2923, 3783-3983. That means sequences of unknown origins or function, which may be harmful, are being approved for environmental release.

Practically no data was provided by Aventis for the location of the transgenic insert (item 30f) other than the statement. "The data indicate that ca. 1 copy of the pat gene and ca. 1 copy … of the ampicillin resistance gene have been integrated into the genome of the T25 line." The precise location and configuration of the insert and data documenting its constancy in successive generations are crucial for demonstrating the genetic stability of the insert for identification and traceability.

The issue of genetic stability is also important for predicting the likelihood of horizontal gene transfer, a topic not addressed at all in the submission. This is a serious omission, as there is now evidence of the transfer of antibiotic resistance genes and other transgenic DNA from GM crops to soil fungi and bacteria, not only in the laboratory but also in the field (see Appendix 1).

3. Potentially hazardous DNA in the insert

The ampicillin resistance gene, even though truncated and promoterless, is known to be very mutable. This point was raised by both the UK Ministry of Agriculture, Fisheries and Food and Advisory Committee on Novel Foods and Processes to the US Food and Drug Administration in commenting on the latter’s "Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants" (See Annual Report, 1998, ACNFP). Moreover, rearrangement or deletion could place the CaMV 35S promoter next to the ampicillin resistance gene to activate it. And horizontal gene transfer into bacterial mobile units such as integrons will provide the missing promoter to reactivate the gene. There is now sufficient evidence for unintended horizontal gene transfer from transgenic DNA to bacteria. The ampicillin resistance gene, though truncated, is not safe.

Another potentially hazardous transgenic DNA is the CaMV 35S promoter itself, which is promiscuous in function, and has a modular structure. It is interchangeable in part or in whole with promoters of other viruses. It also has a recombination hotspot that increases the likelihood of horizontal gene transfer and recombination. This has the potential to reactivate dormant viruses or generate new viruses (see Appendix 2).

The ori-pUC included in the insert enables the transgenic DNA to be replicated independently, should the latter be transferred into bacteria. This will amplify the transgenic DNA and increase its propensity for horizontal gene transfer and recombination.

Finally, the unknown, uncharacterized sequences in the insert may also be hazardous.

4. Tests submitted fail to address impacts on health and biodiversity

One feeding trial was conducted in rats for 14 days, not on the transgenic maize, but on the extracted novel protein, obtained from GM oil seed rape. Rats are monogastrics and have a completely different digestive system from ruminants, which have four stomachs and keep the plant material longer. What relevance has this experiment to the safety assessment of feeding T25 maize to ruminants? Furthermore, this experiment was never completed, and no histopathological data were ever presented.

There were no attempts to characterise the transgenic line for unintended toxins and allergens. The characterisations that were carried out were undiscriminating. Nevertheless, significant differences were often found between transgenic line and nontransgenic counterparts. These were explained away by appealing to variations in other varieties of the species.

There were no attempts to monitor for horizontal gene transfer in the gut of animals. This is particularly important as DNA has been found to survive with little degradation in silage or as the result of most commercial processing in MAFF’s commissioned report (see above).

None of the field trials examined ecological impacts or impacts on biodiversity. Nor was horizontal gene transfer investigated in any of the field trials. Many of the trials included had nothing to do with T25, but were those involving other transformations, including wheat plants and many unspecified plants.

These omissions are glaring in view of scientific evidence that already exists. Horizontal gene transfer has been found to occue (see Objection 3) . New evidence also indicates that herbicide-resistant weeds have emerged from commercial plantings of herbicide- resistant transgenic canola in Canada ("Herbicide Resistant "Frankenweeds" Emerge in Canadian Canola Fields – Triple Reisitant Canola Weeds found in Alberta" Western Producer Mary MacArthus, Camrose Bureau, Feb. 10, 2000 www.producer.com). These weeds are resistant to multiple herbicides: Roundup, Liberty (glufosinate) and Pursuit. Approving T25 maize resistant to glufosinate is definitely going to create herbicide resistant weeds in the UK, and increase the use of herbicides as a result.

Contrary to the suggestions made in Aventis’ submission, glufosinate is far from benign. There is clear evidence that the herbicide is teratogenic in test animals (see for example, Watanabe,T. (1997) Neurosci Lett. ,222,17), and it has not been approved for use in the UK (see Objection 1 above).

Conclusion

In conclusion, Aventis Chardon LL T25 fails to satisfy the minimal criteria of safety to human and animal health and to biodiversity. Its EU 1998 approval was illegal, and it would not satisfy current international and national criteria for safety. There is sufficient scientific evidence of actual and potential hazards arising from transgenic crops such as Aventis Chardon LL T25 for it to be withdrawn from release altogether, especially in accordance with the precautionary principle which is now internationally accepted as the basis of the Biosafety Protocol. It would be irresponsible to add Aventis Chardon LL T25 to the National list.

These written representations are made without prejudice to how Dr Mae-wan Ho and Angela Ryan may wish to present our case at any hearing or at any other administrative or legal proceedings concerning this Listing decision. We reserve the right to make further points at any such hearing or in any such proceedings.

Appendices

  1. Open Letter from World Scientists www.i-sis.org.uk/list.php
  2. The cauliflower mosaic viral promoter – a recipe for disaster? Mae-Wan Ho, Angela Ryan and Joe Cummins, Microbial Ecology in Health and Disease 11, 194-197, 1999.
  3. Transgenic DNA in Animal Feed, Angela Ryan and Mae-Wan Ho, ISIS Report, November, 1999. www.i-sis.org.uk/anifeed.php
  4. Biosafety Alert, Submission to Biotechnology Group of the Trans-Atlantic Economic Partnership on the Molecular Characterisation Required for GMOs. Mae-Wan Ho, December 1999. www.i-sis.org.uk/biosafety.php
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