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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CaMV 35S promoter must be withdrawn immediately from commercial production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
- Open Letter from World Scientists www.i-sis.org.uk/list.php
- 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.
- Transgenic DNA in Animal Feed, Angela Ryan and Mae-Wan Ho, ISIS
Report, November, 1999. www.i-sis.org.uk/anifeed.php
- 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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