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Proposed Addition of Chardon LL Maize to the National Seed List

Statement of Objection made by Richard Johnson on behalf of the Natural Law Party of the United Kingdom

Public Hearing, Novotel, West Hammersmith, London
3 November 2000

 

1. Introduction

I am Richard Johnson, Chairman of the Natural Law Party of the United Kingdom (NLPUK), whose offices are at Roydon Hall, Roydon Hall Lane, East Peckham, Tonbridge, Kent.

NLPUK submitted to MAFF in April 2000 written objections to the proposed addition of the genetically modified maize variety Chardon LL to the National Seed List .

NLPUK, in conjunction with Natural Law Parties in other countries, is seeking a global ban on genetically modified food because of both the known and unknown risks to health and the environment posed by the introduction of recombinant DNA technology in global agriculture.

Chardon LL is the first seed variety using such technology that has been proposed for inclusion in the UK National Seed List. Inclusion in the list would allow the variety to be legally grown on a commercial basis by farmers in the United Kingdom.

NLPUK has submitted to MAFF and this hearing a number of documents in support of its objections to the proposed listing. A schedule of these documents is provided in the appendix to this statement. These documents are referred to in this statement by means of the identification numbers given in parenthesis in the text. These documents are also catalogued by the clerks to this hearing under the general reference-prefix CHD 2.

Some of NLPUK’s concerns regarding the proposed listing of Chardon LL relate to the technical aspects of the DUS (‘Distinct, Uniform and Stable’) and VCU (‘Value for Cultivation or Use’) testing which have been carried out in relation to the variety. It has not always been easy to obtain clear answers from MAFF in relation to some of these concerns. It is, therefore, a matter of considerable regret that MAFF have chosen not to make themselves available at this hearing in order to provide clarification.

Such clarification is required in order to demonstrate that DUS and VCU testing has been carried out in a legally correct and technically robust fashion. Identification of some of these agronomic matters requiring clarification and validation is given in the section immediately following.

These agronomic objections are further supplemented by concerns relating to the impact of Chardon LL on health and the environment. MAFF have confirmed in correspondence that any interested party may submit grounds on which the addition of GM plant varieties to the National Seed List should be refused by Ministers "because, for example, there is new evidence of risk to the health of persons, animals or plants."

Accordingly NLPUK’s objection to the proposed addition of Chardon LL to the National Seed List is provided below under five separate categories as follows:

  1. Agronomic objections
  2. Health objections - persons
  3. Health objections - animals
  4. Health objections - plants
  5. General objections

2. Agronomic Objections

2.1 General

MAFF have advised in their general information supplied to objectors to the proposed listing that under the Seeds (National Lists of Varieties) Regulations 1982 (as amended) candidate varieties must show that they meet certain quality criteria - i.e. that they are: ‘distinct, uniform and stable: and have a value for cultivation or use over those varieties already on the National List’.

This means that the variety must have a ‘clear improvement either for cultivation or as regards the uses which can be made of the crops or the products derived therefrom' compared to other varieties already on the list (60).

2.2 DUS

2.2.1 DUS criteria

The DUS (Distinct, Uniform and Stable) assessment for Chardon LL was carried out in France. It appears that the only characteristic which the applicants are claiming as ‘distinctive’ under the assessment is resistance to the herbicide glufosinate ammonium (see written representations submitted by Aventis CropScience 25 April 2000, MAFF Volume 3, pages 281 and 284)

It is not clear why such resistance to a herbicide has been accepted by MAFF as a characteristic suitable for consideration under the DUS system. Even prior to the advent of recombinant DNA technology many existing plant varieties already on the National List are resistant to herbicides.

World-wide existing sugar beet varieties, for example, are alone resistant to some 28 active herbicide ingredients (74). Has such herbicide resistance been used previously as a valid criterion to permit entry onto the National List under the DUS assessment system?

If it has not, then why should it be used so now? If it has not, then its introduction at this point would appear to indicate that the system is being manipulated to artificially justify the introduction of Chardon LL. Clarification from MAFF on these points is required.

Beyond facilitating the purely artificial management practice of altered herbicide usage the breeders of Chardon LL do not appear to claim any innate characteristic for the variety which enables it to demonstrate its distinctiveness under all growing conditions (for example under those where herbicides may not be used at all, such as in organic agriculture).

If Chardon LL is to be approved for listing MAFF must first demonstrate the legal and technical justification for introducing herbicide resistance as a valid criterion under the DUS system. This is particularly so where such a characteristic is not manifest without the application of a biologically separate chemical entity and where there is no other distinctive agronomic characteristic claimed.

2.2.2 Transgene stability

Chardon LL is a transgenic variety which incorporates foreign genes from unrelated organisms (‘transgenes’) using recombinant DNA technology.

Basic research shows that the expression of transgenes can be affected by environmental factors (6). Transgenes can also display abnormal inheritance (6). Therefore stability of gene expression must be tested under UK as well as French conditions.

As far as the UK VCU trials are concerned (see section 2.3 below) there have been only two locations (Cambridgeshire and Hampshire) where Chardon LL has been tested over more than one season (63). This is inadequate to assess agronomic reliability in the context of plants containing recombinant DNA where transgene instability is an acknowledged phenomenon.

Already there are cases of agronomic problems with transgenic crops in the United States arising AFTER their approval for commercial use due to the behaviour and performance of genetically modified plants in different field conditions (1,2,3,4,5,9,10,11,23,24). In some cases this has led to unexpectedly poor crop performance or even total crop failure causing millions of dollars of economic losses for farmers.

2.3 VCU

2.3.1 Invalid herbicide testing in the trials

Whether or not MAFF are able to justify the DUS assessment the only distinctive characteristic claimed and tested for in the case of Chardon LL is its resistance to glufosinate ammonium herbicide.

It is clear from the marketing literature (21) for this type of crop in the US (where it has already been commercialised) that the sole ‘advantage’ is its resistance to glufosinate. As result the only reason that a farmer will be likely to wish to grow such a variety in preference to others is that he believes that such resistance will confer agronomic advantages on him - i.e. more effective weed control.

However, this is not necessarily the case. Such an approach to weed control can be less effective than more conventional herbicide systems.

Conventional herbicide systems frequently use a ‘residual’ soil-acting chemical strategy which means that weeds are killed as and when they emerge from the soil. The herbicide sprayed on the ground kills the weeds as they break through the surface of the soil and come into contact with the soil-acting ‘residual’ toxicity of the herbicide.

By contrast herbicide programmes linked to genetically modified crops such as Chardon LL are used in conjunction with ‘contact’ herbicides. This type of herbicide only kills those weeds which it has direct foliar contact with at the time of spraying. Therefore only those weeds which have already emerged at the time of spraying are subject to the toxic action of the herbicide. Any weed emerging after the spray application will not be affected.

For this (and sometimes other reasons) GM herbicide resistant crops such as Chardon LL may not provide the degree of weed control anticipated. This may ultimately result in the use of additional herbicides and/or result in reduced yields at harvest.

No farmer is likely to purchase Chardon LL for any reason other than to allow the use of glufosinate on his maize crop. This very specific purpose of the variety is explicitly proclaimed in the name ‘Chardon LL’. Here the ‘LL’ refers to ‘Liberty Link’. ‘Liberty’ is the trade name for the glufosinate herbicide manufactured by the developers of Chardon LL.

That this is a special situation is additionally demonstrated by the fact that none of the control varieties in the VCU trials has a name which is suffixed by letters indicating a particular herbicide tolerance.

Clearly the overriding reason for a farmer wishing to grow Chardon LL (as opposed to other maize varieties on the National Seed List) is its resistance to a new class of herbicide which has a broad spectrum contact-only method of action. It is essential therefore that trials to assess its performance used in conjunction with that specific herbicide are carried out.

Without such testing the ‘distinct’ characteristic of herbicide resistance to glufosinate is meaningless as no improved value for cultivation from it will have been demonstrated. In particular it is possible that the use of such a herbicide may have a disappointing effect on the control of weeds. If so, this is vital information for the farmer when making his choice of variety.

General problems of this and other types (13,14,15,16,17,18,19,20,22,25,26; 64,65,66,67,68,69,70,71,72,73) have already been demonstrated in trials in both the UK and in other parts of the world with crops that have been genetically modified to be resistant to broad spectrum contact herbicides such as glyphosate (‘Roundup’) and glufosinate (‘Liberty’). The latter is, of course, the herbicide which Chardon LL has been genetically modified to be resistant to.

Such trials indicate that single or mistimed applications of herbicide products such as glyphosate and glufosinate may provide disappointing levels of efficacy when used to control weeds in growing crops (as compared with more conventional herbicide regimes). They indicate that either additional herbicides may have to be introduced to restore weed control efficacy, or more frequent applications of the herbicide associated with the genetically modified variety may have to be utilised. These matters have significant economic cost implications for farmers which may impact negatively on the variety’s value for cultivation purposes.

Specifically in relation to maize genetically engineered to be resistant to glufosinate at least one study (67) has already explicitly concluded that: "a weed management strategy with glufosinate must include multiple applications, residual herbicides or mechanical control." This study cannot easily be dismissed as it was carried out by scientists at the Hungarian Academy of Sciences and AgrEvo, the company responsible for the development of Chardon LL (AgrEvo is now a subsidiary of Aventis). It is therefore almost certain that Chardon LL will encounter such problems.

However, it is clear that such problems will not have been identified in the National List trials because MAFF have advised verbally that Chardon LL has been trialed using only conventional herbicide applications and has NOT been tested under the relevant glufosinate herbicide regime. Chardon LL’s especial ‘Value for Cultivation and Use’ in the context of its distinct characteristic of resistance to glufosinate has therefore not been agronomically tested in these trials.

The VCU trial results do not therefore provide the necessary information required for farmers to make objective decisions about its overall agronomic performance relative to other varieties on the list.

In these circumstances the listing of the variety is therefore likely to mislead farmers, many of whom may be willing to believe any unsubstantiated claims (54,56) concerning the agronomic efficacy of such technology because they are not familiar with the relevant scientific literature which often demonstrates significant failings. Promotion of such products by seed companies does not usually seek to draw attention to such deficiencies (21).

Because of the design of the VCU testing procedures such potential deficiencies are not exposed by these National List trials, but nonetheless they are highly likely to exist. Farmers buying Chardon LL based on the proposed National Seed List approval specifically because it enables the use of glufosinate (which is the overriding purpose of the variety) will be doing so not knowing that this may have a damaging effect on the physical and financial performance on their maize crops.

The purpose of the National Seed List is to allow farmers to have access to agronomically sound varieties based on robust scientific assessment. Its purpose should not be to mislead them.

2.3.2 Inadequate number and duration of trials

When NLPUK asked MAFF for a copy of the VCU protocol for the trials it was sent a document which was approved in 1999 (62), and therefore clearly was not the correct document. The correct document was separately acquired by Friends of the Earth and has been submitted by them as part of this hearing under the reference CHD 9, FOE File 1, Tab 11.

This is the National List VCU protocol for maize trials dated 9 April 1998.

Part 1 Para 3 requires that there be ‘two years of trials’.

Part 1 Para 6 requires that there be ‘four trials in England plus one reserve site’. This wording equates the term ‘trial’ with ‘site’.

The combined effect of these two criteria is to require that test results are completed for two seasons of crops from at least four sites. Such a requirement would logically enable assessment of any variability due to season or to regional conditions.

However, the data from the VCU assessment (63) show that those trials at sites in Devon and Cheshire were discontinued after 1998 (or they have not been reported on for some reason) and that new trials were started in Oxfordshire and York in 1999.

As a result only two trials, in Cambridgeshire and Hampshire, have been completed over the required two years. Both of these locations are in the south of England. The addition of Chardon LL to the National Seed List cannot therefore take place in circumstances where the requirement of the protocol for four trials over two years has not been complied with.

Particularly in the context of varying climatic and environmental conditions this situation means that insufficient data has been provided to adequately assess:

  1. consistent performance across seasons

  2. consistent performance across regions outside of the south of England

Other MAFF’s own documentation on VCU testing specifically requires assessors to ‘consider regional performance’ (para 4.3.3 of ref no 61).

Clearly the regional performance, and seasonal consistency of Chardon LL cannot be robustly assessed with the limited data available under these trials.

2.3.3 Discrepancies in VCU scores

There are additional discrepancies and deficiencies in the VCU assessment (63) relating to individual criteria for Chardon LL as compared with those varieties already on the National List. They are as follows:

i) Cob ripeness adjusted for Dry Matter (DM) %

A neutral score of zero is awarded. However, the variety achieves well below the score of all other varieties. Compared with the performance of existing varieties the baseline criteria for "inferior characteristics" has been set at too low a level, at 6.8. All existing varieties are well above this level. A score of minus one or two should be awarded for this measure.

ii) Early Vigour

There is no data for the Hampshire site in 1998. This means that the number of trials carried out on the same site over a two year period (as required by the protocol) is further reduced down to a single instance (Cambridgeshire) for this measure. There is, therefore, insufficient data to award Chardon LL a score of +1 for this measure. There is also no data for the single year site at York.

iii) Lodging

Likewise there is no data for the Hampshire trial for this measure either - this time both in 1998 and 1999. Neither is there any data for the sole remaining two year trial in Cambridgeshire in 1999. This means there are no trials where the measure is assessed over the required two year period (and in fact there is no data for the single year trials in Cheshire and Oxfordshire either). There is therefore insufficient data to award a score of +1 for this measure also.

iv) Brackling

Data for this measure is only provided for the single year sites at Devon, Cheshire and York. No other sites have data for brackling including the two year trial sites in Cambridgeshire and Hampshire.

v) Yield effects of genetic modification tailored to specific herbicide use

As discussed in section 2.3.1 above there is evidence from agronomic trials both in the US and Europe that the use of broad spectrum ‘contact’ herbicides like glufosinate on crops bred to be resistant to them can have a depressing effect on crop performance compared to their use with conventional herbicide programmes.

It is possible therefore that the VCU scores for Chardon LL of +2 in relation to ‘Dry Matter Yield’, and +1 in relation to ‘Early Vigour’, could be erroneous in this additional respect also. Whether this score accurately reflects the actual value of the variety to farmers when used with glufosinate can only be determined by carrying out the following comparative trials:

  • comparison of performance levels of all varieties (including Chardon LL) using a conventional herbicide programme (as MAFF has indicated verbally has been the case)
  • comparison of performance levels of Chardon LL using a glufosinate herbicide programme at the same trial sites

Such comparisons are particularly necessary given that MAFF guidance on VCU testing specifically requires assessors to ‘consider other characteristics for which no standards have been produced for superior or inferior characteristics' (para 4.3.2 of ref no 61).

Farmers rely particularly on the National List to make economic and husbandry decisions about variety selection. In the case of Chardon LL they are choosing a variety specifically because it enables them to use it with a particular broad spectrum ‘contact’ herbicide.

This is a unique situation which does not apply to other varieties on the list. Unlike other varieties on the list farmers choosing Chardon LL are in effect committing themselves to the use of a particular herbicide at the point at which they purchase the seed.

Because of this purposeful linkage it is impossible to assess the actual VCU of Chardon LL without the carrying out of such dual regime comparative trials.

2.3.4 Other agronomic effects arising from the potential persistence of transgenic DNA crop residues in soil

The activity of soil micro and macro-organisms is vital to soil fertility and long term sustainability of farming systems (29). Bacteria in particular form a major part of the soil microcosm’s role in maintaining the agricultural productivity of land.

There is now evidence (27, 28) that transgenic DNA from GM crop plant residues may persist in the soil and exercise horizontal gene transfer with bacteria:

"... It is hypothesized that the introduction of bacterial genes into the plant genome leads to a higher probability of gene transfer from plants to bacteria due to the presence of homologous sequences. However, until now, there has been a lack of clear experimental evidence that successful gene transfer from plants to bacteria can occur at all...

"...In this study transformation of naturally competent bacteria by transgenic plant DNA, even with plant homogenates, was demonstrated for the first time...

....Recently, horizontal gene exchange between distantly related bacteria as well as gene exchange from bacteria to yeast, mammalian cells, and plant cells has been reported...." (Gebhard and Smalla, 1998) (27).

The risk of such novel and potentially unfavourable interactions is exacerbated by the fact that most transgenic crops include artificially inserted genetic sequences from either bacteria or viruses which are embedded in every cell. The Chardon LL variety in fact includes both such elements. The viral element is a promoter from the Cauliflower Mosaic Virus (CaMV). This element is known to be susceptible to creating rearrangements of exogenous DNA (12), a phenomenon which may cause variations in transgene expression and other unintended effects (42, 43).

Despite these special factors (which do not apply similarly to the existing non-transgenic maize varieties on the National List) no assessment of the impact of such recombinant plant DNA on soil biology has been made ACRE (the body responsible for assessing the environmental impact of deliberate releases of GM crops). Any adverse effect from Chardon LL arising in this area could have a damaging effect on soil fertility and as a result produce a lower value for cultivation for farmers.

Any effects on soil micro and macro-organisms are additionally important because they also play an significant role, not only in plant nutrition, but also in the prevention of plant disease (29, 30).

3. Health objections - risks to persons

Although Chardon LL is intended to be used in the UK as a forage maize fed to livestock there appears to be no guarantee that it will be prevented from entering the human food chain directly (e.g as a source of starch). Well publicised events in the US earlier this month have lead to a genetically modified maize approved only for animal feed entering the global human food chain by mistake. The maize concerned is one developed by the same company as that which has bred Chardon LL.

In the event of Chardon LL entering directly into the human food a chain a number of safety issues arise:

3.1 Inadequate toxicity testing

The Chardon LL maize has been assessed by the Advisory Committee on Novel Foods and Processes (ACNFP) under ‘fast track’ procedures which limit the type of testing carried out. This assessment has been carried out in error as fast track procedures are only available for food products which do not contain GMOs. There is clear evidence that food products from Chardon LL will contain GMOs (32).

It is known that GMOs may contain new toxins or allergens, or increase existing levels (33,34,55). These have not been adequately tested for under the fast track procedures for Chardon LL.

Chardon LL was considered by the Advisory Committee on Releases to the Environment (ACRE) between 1996 and 1998 when it indicated that it was satisfied that T25 type maize (of which Chardon LL is one) did not pose a risk to human health and the environment.

Since 1998 the EU has advised member states to apply more rigorous safety assessments. New evidence of the bio-safety risks and the environmental impact of the use of recombinant DNA technology (see publication dates accompanying submitted references for some examples) has also emerged since Chardon LL was originally assessed, reinforcing the need for the reappraisal and supplementation of previous testing. No such process has taken place in respect of Chardon LL

3.2 Inappropriate toxicity testing

One of the key novel elements of Chardon LL is the inclusion of the ‘PAT’ gene which makes the maize plants resistant to glufosinate.

Remarkably the toxicity of the PAT gene has not been tested as it exists in Chardon LL. The only testing which has taken place during the approval procedure is on the toxicity of the ‘PAT’ gene in a completely different organism (oilseed rape). Dr Vyvyan Howard has already given evidence to this hearing on this matter on behalf of Friends of the Earth.

This is an extraordinary scientific oversight as it is well established that the expression of transgenes can be significantly influenced by the background genome in which they are placed (6, 7, 33, 34). In the case of Chardon LL the toxicity of the gene has not been tested in the context of the relevant background genome.

There has been no general toxicity testing for Chardon LL even though it is well established that GMOs can create new toxins. Only a narrow number of constituent elements have been examined. Even with these there have been found to be statistically significant differences compared with non-genetically modified maize (32).

In its application for marketing approval, the breeder of T25 maize has stated that "many of the compositional parameters for GTC [glufosinate tolerant corn] were statistically significantly different from the non transgenic counterpart..." (32). In fact, the company found significant differences in fat, carbohydrate, amino acid and fatty acid composition.

These differences make the variety ineligible for the fast track approval procedures (32).

3.3 Use of the Cauliflower Mosaic Virus Promoter

The use of the Cauliflower Mosaic Virus promoter in Chardon LL may have implications for human health as well as animal and plant health (see sections 4 and 5 below).

The CaMV source virus for the promoter is closely related to Hepatitis B (both viruses are Group VII viruses) (75), and recent research has also demonstrated some componental interchangability between the source virus and HIV (37).

ACRE claims it has carried out a recent assessment of the safety of the use of the CaMV promoter in transgenic plants. However, it is not clear how much of the most recent research on the risks associated with this element ACRE has considered - or how it has chosen to interpret any relevant research in this area placed before it. There are a number of reasons as to why the use of this promoter in transgenic crops is a cause for concern:

  1. It has only recently been shown to have a recombination ‘hotspot’ associated with rearrangements of DNA in transgenic organisms. It is possible, for example, that the recombination of such virus-related genetic sequences could give rise to the creation of new viruses (8, 42, 43).

  2. The source virus is closely related to important human viruses (75).

  3. It is inserted into transgenic plants in a form which is different to that occurring in its originating plant virus - this enables it to operate in an exceptionally wide range of genetic host environments and in a less restrictive way to that which would normally be possible (75).

  4. In this context evidence has recently come to light showing that a plant virus may be able to switch host into the animal kingdom and produce a new animal kingdom virus (36).

  5. The CaMV promoter is also clearly associated with gene silencing phenomena where transgenes can be unintentionally switched off (6,38,39,40,41,59).

The behaviour and fate of this volatile foreign genetic element when introduced into food chain and ecosystem environments is not yet properly understood (see also section 5.2 below).

4. Health objections - risks to animals

4.1 Feeding trials

Similar or related health risks may apply to animals fed Chardon LL as they do to humans eating food products derived from it (see section 3 above).

Chardon LL is primarily intended to be grown as a source of silage for cattle (although it also has an EU marketing consent for food products). Extraordinary though it may seem no feeding trials for this variety have been carried out involving ruminant animals (31). This is despite the fact that the maize is intended to be mainly fed unprocessed to cattle.

In addition the matter has not been considered by the recently established Advisory Committee on Animal Feedstuffs (ACAF). This is despite the fact that in December 1999 the committee stated that "feeding trials carried out with monogastrics would not be applicable to ruminants" (31).

Professor Bob Orskov has given additional important evidence earlier in this hearing on behalf of Friends of the Earth on the lack of adequate feeding trials on ruminants for Chardon LL.

4.2 Impact on soil organisms

This matter has already been commented on under section 2.3.4 above. The implications may be profoundly adverse if recombinant DNA is introduced into UK agriculture in the absence of adequate risk assessment in this area (58).

4.3 Use of Cauliflower Mosaic Virus Promoter

This matter has already been commented on under section 3.3 above. Similar risks apply to animals as to humans when considering interactions with this type of recombinant DNA. These may not only apply to farm animals but to wild animals (deer etc) who may graze crops in the field.

5. Health objections - risks to plants

5.1 Cross pollination with neighbouring crops

In 1999 the National Pollen Research Unit produced a report (35) identifying a greater risk of the transfer of transgenic DNA between maize crops via pollen than had previously been widely acknowledged.

Despite this the government has not required a corresponding increase in separation distances between GM and non-GM maize crops as specified in the SCIMAC GM crop management protocol which it has endorsed. This would appear to be in breach of new EU guidelines on GM crop risk assessment (see section 6.2 below).

Where there are significant levels of pollen-mediated transfer of recombinant DNA between crops, this may have damaging economic or environmental consequences for neighbouring farms. Those consequences may include adverse effects on value for cultivation or use of plants grown on those neighbouring farms particularly where crops are rendered unusable in certain markets (76).

5.2 Use of the Cauliflower Mosaic Virus Promoter

In addition to the risks discussed in section 3 above it has become particularly apparent in recent years that the use of the CaMV promoter in transgenic plants is also associated with ‘gene silencing ’phenomena - the unintended switching off of transgenes in genetically modified plants. This has important implications for plant health and environmental safety. According to the John Innes Centre (7):

".....Recent research in our laboratory with Brassica napus plants containing the 35S promoter from the mosaic virus (CaMV) has shown that upon infection with the CaMV the driven transgene is silenced (Al-Kaff et al unpublished). Intensive research at present is directed towards understanding this silencing mechanism and its significance.
As the 35S promoter is widely used to regulate transgenics in brassicas, it is important that we strive to obtain a clear understanding of the mechanisms of this silencing and its significance. This is important for two reasons, for assessing the use of the 35S promoter in agriculture and also for assessing the significance of this effect for biosafety...."

and also (38):

"The most commonly used regulatory element in transgenic crops is the 35S promoter from cauliflower mosaic virus (CaMV)..... One consequence of these findings for biotechnology is that crop plants containing transgenes regulated by pathogen-derived elements, such as the commonly used CaMV 35S promoter, could be compromised when released into the environment if they encounter a homologous pathogen."
6. General Objections

6.1 Non-eligibility for ‘fast track procedure’

Because of the likely presence of GMOs in food products derived from Chardon LL and evidence of their non ‘substantial equivalence’ their assessment under fast track procedures under the Novel Food Regulation is likely to be unlawful in the event of their being allowed directly into the human food chain (32).

6.2 Changed risk assessment procedures


The breeder of Chardon LL submitted its application for EU marketing approval for T25 types of GM maize (of which Chardon LL is one) in 1996, and this was granted in 1998. Since then, the EU Deliberate Release Directive (90/220) has been in a process of revision.

One of the major revisions of the Directive has been a substantial increase in the rigour of risk assessments required before approval for the marketing of a GM crop. Applicants for marketing approval are now required to look at more issues, including (31):

  1. indirect and delayed effects of the release

  2. delayed effects on animal health and consequences for the food/feed chain

  3. impacts on the soil and soil nutrient cycling

  4. immediate, delayed, direct and indirect impacts of changes in agricultural practice brought about as a result of the release of the GM crop

In this case the plant breeder did not examine these issues for T25 maize as part of its submission.

In addition, any application for GM marketing approval must now include a monitoring plan (31). This is to pick up any unexpected impacts on the environment from the release of the GM crop. There is no such monitoring plan for T25 maize.

In a declaration made by the EU Council of Ministers in December 1998, it was stated that the changes were so important that they should be applied immediately, even before the revised EU Directive comes into force. Since then, all applicants for EU marketing approval have been required to meet these more rigorous requirements.

In April 1999, the UK Environment Minister announced that he was widening the remit and membership of ACRE in order to take into account these widened requirements. The new ACRE committee has not considered T25 maize. As a result Chardon LL has not been assessed in compliance with the criteria established under the latest protocols.

6.3. New evidence of risk since the original 1996-98 ACRE assessment

A range of research relating to risks from GMOs has been published since the original ACRE risk assessment of Chardon LL. Some of those scientific papers published during and after 1996 (when the Chardon LL application to ACRE was first made) are included in the documents submitted to this hearing by NLPUK (see publication dates accompanying submitted references).


On the basis of these developments, and the new guidance issued by the EU in 1999 regarding risk assessment, Chardon LL requires a reappraisal. This is likely to necessitate the carrying out of new research relating to any additional areas of risk that are identified as part of that process.

6.4 Farm scale trials

The UK government has given an undertaking that no commercialisation of GM crops will be permitted before the completion of farm scale trials, including trials on Chardon LL maize, which are due to finish in 2003.

Nonetheless the addition of Chardon LL to the National List at this point would make it legal for farmers to grow the variety commercially.

Clearly, therefore, it cannot be appropriate for this variety to be included in the National List until such time as the farm scale trials have been completed, and it has been demonstrated that there are no unacceptable adverse effect.

If for no reason other than that this, it is both entirely premature and inherently unscientific for Chardon LL to be included on the National List at this point. Inclusion in the list at this stage will threaten the basic validity and purpose of the farm scale trials especially in so far as they relate to this type of maize.

This is particularly so given that the John Innes Centre advises as follows (6):

"When transgenic plants are evaluated, it is important to determine whether there is evidence of enhanced or modified transgene expression in different environments....

One of the most challenging issues associated with assessing the environmental impact of transgenic plants when in widespread commercial production are scale dependent effects. It is possible that a rare event may have insignificant consequences when transgenic crops are grown on a small experimental scale, but become more important when transgenic crops are grown over thousands of hectares.......

It is unrealistic to assume that every facet of environmental impact can be addressed and predicted from assessment of small scale experimental plots....."

The bio-safety risk assessments completed to date in respect of Chardon LL have only been carried out in laboratory conditions or in relation to small scale experimental plots.

6.5 Conceptual problems with recombinant DNA technology

Natural Law Parties around the globe have produced a position statement document setting out their universal objection to the introduction of recombinant DNA in world agriculture. That document is amongst those submitted to this hearing (53).

Such objection is supported by a wide spectrum of empirical evidence and scientific opinion (44, 45,46,47,48,49,50,51,52,53,54,55,56,57,58). NLPUK, however, wishes to draw particular attention to the fundamental nature of its scientifically based objection to the use of such technology.

Recombinant DNA technologies do not take into account the holistic functioning of an organism. It is therefore inevitable that they do, and will, lead to unpredictable and unlimited effects on genetically modified organisms and ultimately the environment and the consumer. One fundamental reason why the current models of recombinant DNA technology are inadequate is that they pay little attention to the quantum mechanical nature of the DNA molecule.

NLPUK is calling expert witness evidence at this hearing in relation to this area, but reference is also made to the following extract from the Natural Law Parties' international position statement:

"... With the arrival of recombinant DNA technology many of the world’s biologists have failed to grasp the overwhelming significance of making fundamental changes to the genomes of animals and plants in a way which completely ignores the contextual basis by which all evolutionary mechanisms are driven. These mechanisms have guided the development of species since the moment life began on earth.

In the context of the vast time horizons of evolution’s past and future development the transgenic (or ‘genetically modified’) organisms that have been developed to date using this technology represent just the merest few milliseconds at the start of what is proposed to be a continual process of radical change to the planet’s biology. This is a process which already recognises few if any boundaries.

It is naive to believe that the scientific and commercial interests promoting this technology will encourage substantial limitations on this range in anything other than the short term. Transgenic technology is specifically designed to break biological boundaries that have been robustly established and maintained over enormous periods of time.

It is certainly true to state that all genes, irrespective of organism, consist of the same fundamental components - the nucleotide ‘bases’ of which there are only four. However, much conceptual thinking in recombinant DNA technology is erroneously based around the assumption that because this universal commonality is shared by all genes and genomes it is reasonable to ‘cut and splice’ genes out of context from one organism into another without the inconvenience of ‘in-principle’ technical, ethical and political restrictions.

DNA is a biological language specific to each organism and responsible for generating all its functions and characteristics through the generation of proteins. The particular language or ‘dialect’ is unique to that organism even though some or many elements of that language may be found in other organisms, especially related ones.

The nucleotide ‘bases’ comprise the alphabet of the language of each organism. The same four bases are used in the genome of all organisms (whether of the same species or not). In that limited sense every organism is the same. But we know that all organisms are not the same and that there is huge diversity amongst them. Those differences are generated not by the use of different components or alphabets, but by the structure of the different ‘languages’ or ‘dialects’ which go to make up the different relationships which exist within them.

By analogy most European written languages are similarly built from a common (Roman) alphabet. Although in some rare cases it may be possible to ‘cut and splice’ a word from the French language into an English sentence and conserve or enhance its meaningfulness, usually meaning will become distorted. In other words in any language context is paramount. So also in the languages of genetics - the same gene operating in a different genetic context may have radically different effects, not all of which will be readily apparent or easily understood irrespective of the diligence of risk assessment procedures.

In the field of genetics biotechnology has to date succeeded in learning the genetic ‘alphabet’ common to all organisms. It has also learnt some of the words that exist in the language of particular genomes. But not much more. To extend the analogy further genetic engineers know little about genetic punctuation, syntax, grammar, paragraph construction and so on. In other words biotechnology holds some basic knowledge about genetic components but very little about genetic relationships. Without knowledge of such relationships, adequate fluency in genetic language is not obtainable. Without this fluency reliable assessment of risk is nothing more than a goal based on wishful thinking and corporate optimism.

Not surprisingly, therefore, we find ourselves in a situation where we are at least two generations of scientists away from having a broad enough understanding of the genetic functioning of higher organisms sufficient to provide a realistic prospect of assessing the consequences of incorporating recombinant DNA into global agriculture."

6.6 Recombinant DNA technology and its wider implications

In addition to its ‘in principle’ objections to the introduction of recombinant DNA into British agriculture NLPUK also wishes to draw attention to the wider social implications of the highly unscientific approach which the government of the United Kingdom has taken in relation to these matters.

What the Government’s misplaced facilitation of the use of this technology in UK agriculture reveals is not simply a problem concerning the 'science' of genetic engineering itself, or even the health of the relationship between science, commercial interests, regulatory authorities, and government. What it reveals is a much deeper problem of consciousness. It is essentially a problem of the way the Government and many of its advisers have learnt to think. What it particularly demonstrates is an inability to learn from experience and to think and act holistically.

As such the debate about genetic engineering raises questions not simply about the use of the technology itself, but about the very nature of the society that we are trying to create at the beginning of the twenty-first century. Do we wish to build a society which harnesses natural law, or one that violates it; one that nurtures life (including our own) or one that destroys it?

These are questions of immense importance, and they are ones not to be considered on an exclusive basis solely by senior scientific, commercial and political professionals. These are questions to be considered by every man and every woman, and particularly by those who are most directly responsible for the thought processes and values of our society at the beginning of the new millennium - our teachers and educators.

It is time for our educational systems to recognise the significance of the most important discoveries of modern science - not the fragmented discoveries of ‘genetic engineering’, but rather the holistic discoveries of the ‘unified field’ theories of quantum physics and their profound relationship to the most advanced developments in educational and cognitive science.

These are discoveries that recognise that we live in an integrated and intelligent universe, and that everyone may access and draw upon the immense resources of that intelligence for the purpose of their own personal growth and development. This is an approach which is both self-sustaining for the individual whilst being simultaneously nurturing to the society and natural environment which surrounds us.

This hearing is the first occasion that the citizens of the United Kingdom have been afforded an extensive formal opportunity to raise such issues in the context of the misuse of science in the field of biotechnology.

NLPUK is therefore today submitting its own representations on these issues as a matter of public record through the medium of this hearing. These representations are accompanied by extensive scientific references which are already in the public domain and available to governmental decision makers. Governmental pleas of ‘ignorance’ as an administrative defence to future claims of personal injury and environmental damage arising from the introduction of this technology will not be sustainable.

Through the vehicle of this hearing NLPUK is therefore placing Her Majesty’s Government on notice. It is especially appropriate that it does so in the week following the release of the Phillips report into the conduct of the Government during the BSE crisis.

Like the phenomenon of new variant CJD, the controversy surrounding the use of recombinant DNA in the food supply is also centred around the breaching of biological boundaries between unrelated species. The principal difference between the two is that in the case of recombinant DNA such breaches are deliberate and are targeted at all foodstuffs.

Accordingly NLPUK hereby informs the Government that any further failure to bring an immediate halt to the introduction of recombinant DNA technology in British agriculture constitutes a profound breach of its own moral and legal obligations to protect the well-being of the citizens of the United Kingdom and the integrity of their environment.

Such a profound breach represents a deep abrogation of the Government’s responsibilities. It is a breach which violates the basic tenets of the ‘precautionary principle’ enshrined in European law and the fundamental human right of British citizens to be able to eat unadulterated food.

7. Expert Witnesses

The NLPUK is conscious that a large number of technical witnesses have already been called to give evidence at this hearing. In the interests of brevity it does not seek to recall any of those witnesses, even though their testimony provides further strength to the objections that have been made in this statement.

However, in support of its stated objections to the proposed addition of Chardon LL to the National Seed List NLPUK wishes to call the following further witnesses:

  1. Dr Michael Antoniou

  2. Dr Geoffrey Clements

Richard Johnson,
Chairman,
Natural Law Party, UK
3 November 2000

 

APPENDIX

National Seed List Hearing
Chardon LL

Reference Documents Submitted by Natural Law Party UK

      1. Blaine, A (2000), Agronomy notes Mississippi State University Extension Service, January
      2. New Scientist, 20 November (1999) ‘Monsanto's modified soya beans are cracking up in the heat’
      3. Edmisten K.L et al (1999) ‘Concerns with Roundup Ready Cotton’
      4. McCarty W. (1999) Agronomy notes Mississippi State University Extension Service, October
      5. Larson, E. (1999) Agronomy notes Mississippi State University Extension Service, March
      6. Dale P.J et al (1998) 'Environmental Impact of Transgenic Plants'
      7. Dale P.J et al. (1998) ‘Transgene expression and stability in Brassica’
      8. Hull, R (1998) ‘Detection of risks associated with coat protein transgenics’.
      9. Hagedorn C (1998) Virginia Tech University, Crop and Soil Environmental News, May
      10. Hagedorn C (1997) Virginia Tech University, Crop and Soil Environmental News, December
      11. Hagedorn C (1997) Virginia Tech University, Crop and Soil Environmental News, May
      12. Kohli A et al, ‘Engineering pest- and disease-resistance in cereal crops: fundamental and applied aspects of transgene expression’, John Innes Centre Annual report, 1998/9, p22-23
      13. A M Dewar et al (2000) "Delayed control of weeds in glyphosate-tolerant sugar beet and the consequences on aphid infestation and yield"
      14. Green, M et al (1999) ‘The Familiarisation and Acceptance of Crops incorporating Transgenic Technology (FACTT). A Summary of UK trials.’
      15. Ferrell et al (2000) "Comparison of Weed Management Strategies with Roundup Ready Corn"
      16. Oplinger, E. S. et Al, (1999) "Performance of Transgenic Soybeans in the Northern U.S."
      17. University of Nebraska (2000) ‘Research Shows Roundup Ready Soybeans Yield Less’
      18. American Cyanamid (1998) ‘Field Trial Results Show Economics of Weed Control in Roundup Ready and Elite Soybeans’
      19. Benbrook, C. (1999) "Evidence of the Magnitude and Consequences of the Roundup Ready Soybean Yield Drag from University-Based Varietal Trials in 1998"
      20. Farm Journal (1999), ‘To Pre or not to Pre?’
      21. Dekalb (1997), Corn Business Bulletin, Corn Resistant to Liberty Herbicide
      22. AgrEvo Canada, Liberty Link Weed Control Programmes
      23. Bacheler J.S (2000) ‘Cotton Performance Expectations for North Carolina Producers’, March
      24. Natural Law Party Wessex, ‘Bt GM Cotton less profitable than conventional Cotton as ‘stink bugs’ hit back’
      25. Natural Law Party Wessex, ‘GM rape fails to perform as study reveals erroneous baisis for UK fieldscale trials’
      26. Natural Law Party Wessex, ‘New Study on Transgenic Sugar Beet’

      27. Gebhard, F. & Smalla, K. (1998) 'Transformation of Acinetobacter sp. Strain BD413 by Transgenic Sugar Beet DNA'
      28. Gebhard, F. & Smalla, K. (1999) "Monitoring field releases of genetically modified sugar beets for
        persistence of transgenic plant DNA and horizontal gene transfer"
      29. Butterworth, W. (1999) 'Balancing soil inputs', Arable Farming September 25 1999
      30. Smith, K.P., et al (1999). "Genetic basis in plants for interactions with disease-suppressive bacteria"
        *********************************************************************
      31. Friends of the Earth Cymru Response to ACRE Secretariat paper to National Assembly for Wales 27 March 2000
      32. Friends of the Earth Cymru Response to ACNFP Secretariat paper to National Assembly for Wales on T25 maize foods 27 March 2000
      33. Mayeno, A.N. et al., (1994) ‘Eosinophilia-myalgia syndrome and tryptophan production: a cautionary tale’
      34. Nordlee, J.A et al, (1996) ‘Identification of a Brazil-Nut Allergen in Transgenic Soybeans’
        Friends of the Earth Briefing Sheet - Genetically engineered oilseed rape **********************************************************************
      35. Emberlin, B et Al, (1999) ‘A Report on the Dispersal of Maize pollen National Pollen Research Unit/Soil Association’
      36. Gibbs M J et al, (1999) 'Evidence that a plant virus switched hosts to infect a vertebrate and then recombined with a vertebrate-infecting virus.'
      37. R.Noad, et al John Innes Centre annual report (1998/999) ‘Analysis of animal retroviral elements utilising a plant pararetroviral vector’, p62
      38. Al-Kaff, N et al John Innes Centre annual report (1997/8), ‘Transgene silencing by cauliflower mosaic virus infection’ p19
      39. ’Metzlaff, M et al John Innes Centre annual report (1998/9), ‘Gene silencing in petunia alters the developmentally controlled nuclear processing of primary transcripts’, p33
      40. Nadia S et al (1998) ‘Transcriptional and Posttranscriptional Plant Gene Silencing in Response to a Pathogen’
      41. Nadia S et al (2000) ‘Plant’s rendered herbicide-susceptible by caulilflower mosaic virus-elicted suppression of a 35S promoter-regulated transgene’
      42. Ho et Al, (1999) ‘Cauliflower Mosaic Viral Promoter - A Recipe for Disaster?’
      43. Ho, et al (2000) ‘Hazards of Transgenic Plants Containing the Cauliflower Mosaic Viral Promoter’

      44. Tappeser, B et Al (1998) "Survival, Persistence, Transfer - An Update on Current Knowledge on GMOs and the Fate of their Recombinant DNA"
      45. Ho, M (1999) ‘Special Safety Concerns of Transgenic Agriculture and Related Issues’
      46. Ho, M (2000) ‘Horizontal Gene Transfer - The Hidden Hazards of Genetic Engineering’
      47. a) Clark, E.A (1998) ‘Environmental Risks of Genetic Engineering’
        47. b) Clark, E.A (2000) ‘What is "sound science"?’
      48. Consumers Union, Comments on Docket No 99N-4282, ‘Biotechnology in the year 2000 and Beyond Public Meetings’
      49. Brown, P (2000) ‘The Promise of Plant Biotechnology - The Threat of Genetically modified organisms’
      50. Civil Action No. 98-1300 (CKK) DECLARATION OF Dr. Richard Lacey, M.D., Ph.D.
      51. Civil Action No. 98-1300 (CKK) DECLARATION OF John Fagan, Ph.D.
      52. Civil Action No. 98-1300 (CKK) DECLARATION OF PHILIP J. REGAL, Ph.D.
      53. Natural Law Party: "Immediate Global Ban of GM food"
      54. Natural Law Party Wessex: "Will GM crops deliver benefits to farmers?"
      55. Natural Law Party Wessex: "What leading scientists and public figures have said about the dangers of genetically modified foods"
      56. Natural Law Party Wessex: "The Emperor’s transgenic clothes"
      57. Natural Law Party Wessex : "The Millennium Choice: Genetic Engineering or Natural Law?"
      58. Natural Law Party Wessex: "Are GMOs essential for effective sustainable agriculture in a hungry world?"
      59. Natural Law Party Wessex: "GM rape changes character - gene silencing"

      60. MAFF, "Assessment of value for cultivation or use of agricultural plant varieties"
      61. MAFF, "Criteria for assessing VCU in forage maize - operational aspects" (paper 68-5)
      62. MAFF, "Protocol for conducting trials of FORAGE MAIZE varieties to establish Value for Cultivation and Use for National List purposes 1999"
      63. MAFF, Herbage VCU Group, February 2000 (Agenda 4d, Paper No.68-7)

      64. 1998 Weed Science Society of America Titles and "Abstacts, Preemergence herbicide systems in Roundup-Ready® soybean." C. R. Medlin*, D. R. Shaw, and A. Rankins, Jr., Mississippi State University, Mississippi State.
      65. 1998 Weed Science Society of America Titles and Abstacts, "Weed management in glyphosate-tolerant cotton (Gossypium hirsutum)." Shawn D. Askew*, William A. Bailey, and John W. Wilcut, North Carolina State University, Raleigh.
      66. 1998 Weed Science Society of America Titles and Abstacts, "Weed control systems utilizing glufosinate and glufosinate-resistant crops." R. L. Ritter* and H. Menbere, University of Maryland, College Park.
      67. 1998 Weed Science Society of America Titles and Abstacts, "Three-years experiences about the weed control efficacy and selectivity of glufosinate in transgenic maize." Z. Berzsenyi*, J. Kopacsi, T. Arendas, P. Bonis, and D.Q. Lap, Agricultural Research Institute of the Hungarian Academy of Sciences, Martonvasar, AgrEvo Co Ltd. Budapest, Hungary.
      68. 1998 Weed Science Society of America Titles and Abstacts, "Weed management in glyphosate- and glufosinate-tolerant corn." William G. Johnson*, P.R. Bradley, and S. E. Hart. University of Missouri, Columbia, and University of Illinois, Urbana.
      69. 1998 Weed Science Society of America Titles and Abstacts, "Herbicide management systems in no-till glyphosate tolerant soybeans." Karen A. Corrigan* and R. G. Harvey, Graduate Research Assistant and Professor, University of Wisconsin, Madison.
      70. 1998 Weed Science Society of America Titles and Abstacts, "A comparison of weed management strategies in wide and narrow row glyphosate-resistant soybeans." Kelly A. Nelson* and Karen A. Renner, Michigan State University, East Lansing.
      71. 1998 Weed Science Society of America Titles and Abstacts, "Optimization of glyphosate rate and application timing for weed control in Mississippi glyphosate-tolerant soybean." M.C. Smith*, D. R. Shaw, and M. W. Shankle, Mississippi State University, Mississippi State.
      72. 1998 Weed Science Society of America Titles and Abstacts, "Roundup-Ready® programs for purple nutsedge (Cyperus rotundus) control in soybean". S. M. Schraer*, D. R. Shaw, and A. C. Bennett; Mississippi State University, Mississippi State.
      73. 1998 Weed Science Society of America Titles and Abstacts, "Interaction of glyphosate with selected herbicides for control of redvine." C. L. Brommer*, Mississippi State University, Mississippi State, K. N. Reddy, USDA-ARS, Southern Weed Science Research Unit, Stoneville, MS, and D.R.Shaw, Mississippi State University, Mississippi State.
      74. Beet Research Organisation, Volume No.2 Summer 2000 "GM sugar beet - The present situation"
      75. Natural Law Party Wessex: "Risks Associated with the Use of the Cauliflower Mosaic Virus Promoter in Trangenic Crops"
      76. Chartered Surveyor Monthly, Nov/Dec 98, 'Genetically Modified Crops Spell Trouble on the Farm'
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