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[SANET-MG] EU say no to GM oilseed rape GT73
http://www.i-sis.org.uk/NTGMORGT73.phpISIS Press Release 22/09/04
No to GM Oilseed Rape GT73
Monsanto has applied to import its GM oilseed rape GT73 into Europe for
use in animal feed and processing. The Scientific Panel on GMOs of the
European Food Safety Authority has given it a favourable opinion, and
there will soon be a vote on it at the Council of Ministers. Here’s a
description of what it is and why it should be rejected. Prof. Joe
Cummins, Dr. Mae-Wan Ho and Lim Li Ching
Oilseed rape is a major crop for oil and animal feed
Oilseed rape (Brassica napus) is grown as a commercial crop in 50
countries with a combined harvest of over 40 million metric tonnes. The
major producers of rapeseed in 2000 were China, Canada, India, Germany,
France, Australia, and the United Kingdom. Canola is a genetic variation
of B. napus with low levels of the natural rapeseed toxins glucosinolate
and erucic acid. Canola is grown for its seed, which represents a major
source of edible vegetable oil and pressed cake from oil extraction is
also used in livestock feeds . Oilseed rape is called canola in North
America because the commercial oil-producing varieties were developed in
Monsanto’s canola GT73 was released commercially in 1995 in Canada 
and the same strain, designated RT73, was released commercially in the
United States in 1999 . Japan approved the release of GT73 in 1995
 and Australia in 2003 . Approval of all releases was based on
essentially the same data sets.
GT73 in the EU
GT73 was notified for food use (as rapeseed oil) in the European Union
(EU) in November 1997, under the simplified procedure of the Novel Foods
Regulation. This means that rapeseed oil from GT73 was considered
‘substantially equivalent’ to its conventional counterpart and only
required notification by the company, with no risk assessment or
explicit approval process. Products made from rapeseed oil may include
fried foods, baked foods and snacks.
An application for the import and use of GT73, excluding cultivation,
was submitted in 1998 to the competent authority of the Netherlands. It
gave this application a favourable opinion, and in January 2003
recommended that GT73 be approved. Several member States raised
questions, including the UK, via its Advisory Committee on Releases to
the Environment (ACRE) . One of the concerns related to increased
liver weights in rats fed GT73, compared with controls (see later).
The European Food Safety Authority’s (EFSA) Scientific Panel on GMOs was
requested to give its opinion on GT73 to resolve the uncertainties. In
February 2004, EFSA gave its verdict that "GT73 oilseed rape is as safe
as conventional oilseed rape and therefore the placing on the market of
GT73 oilseed rape for processing and feed use is unlikely to have an
adverse effect on human or animal health or, in the context of its
proposed use, on the environment" .
Despite EFSA’s positive assessment of GT73 for feed and processing, the
regulatory committee could not reach a qualified majority to authorize
GT73 in June 2004. There were 43 votes in favour of approving GT73
(Belgium, Czech Republic, Finland, France, Netherlands, Latvia,
Portugal, Slovakia, Sweden), 57 votes against (Austria, Cyprus, Denmark,
Estonia, Greece, Hungary, Italy, Malta, Lithuania, Luxembourg, Poland,
UK), and 24 abstentions (Germany, Ireland, Spain, Slovenia) .
The application now passes to the Council of Ministers, which will make
its decision very soon. If the Council cannot decide, the decision will
rest with the European Commission, which has shown every sign of being
in favour of approving GT73.
No event-specific characterization provided of transgene insert
GT73 (RT73) oilseed rape has been made tolerant to the herbicide
glyphosate. Two transgenes were used. The first is the epsps gene coding
for the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS),
isolated from the common soil bacterium Agrobacterium tumefaciens, and
is a glyphosate tolerant form of EPSPS. The EPSPS enzyme is part of the
important shikimate pathway involved in the production of aromatic amino
acids. When conventional canola plants are treated with glyphosate, the
plants cannot produce the aromatic amino acids and die, but the enzyme
encoded by the transgene is insensitive to glyphosate.
The second transgene in GT73 codes for a modified version of glyphosate
oxidase (GOX) enzyme. The gox gene inserted into GT73 was isolated from
the bacterium Ochrobactrum anthropi. The GOX enzyme accelerates the
normal breakdown of the herbicide glyphosate into two compounds,
aminomethylphosphonic acid (AMPA) and glyoxylate [1-3, 7]. In the
absence of GOX, unacceptable levels of the herbicide may accumulate in
the canola cake in animal feed.
The two transgenes were introduced into GT73 in a plasmid using the
bacterium, Agrobacterium tumefaciens. The epsps and gox genes were each
driven by the 35S promoter from a modified figwort mosaic virus and
terminated with the 3’ (terminal) end of the pea rbcS E9 gene. The
shikimate pathway is located in the chloroplast, so the chloroplast
transit signal peptide sequence from the ribulose-biphosphate
carboxylase and EPSPS of Arabidopsis is used to target the transgene
products to the chloroplast. According to the company, only the primary
genes and the sequences necessary for their activity in the plant cell
were inserted into the canola cells while sequences from the plasmid
such as the plasmid origin of replication and a gene for streptomycin
resistance were lost from the commercial strain. Monsanto claimed that
only one transgene insert is present , but the exact site of
insertion was not reported [3, 5].
After evaluating the initial application submitted by Monsanto, some
member States had requested additional information on the molecular
aspects of the dossier. However, it is clear from the EFSA opinion that
no independent tests were carried out, and the favourable opinion was
based solely on information supplied by the company. Worryingly, the
EFSA opinion  stated: "Comments raised by the Member States on
specific molecular detection methodologies are presently not within the
scope of the GMO Panel remit." In other words, there is no
event-specific characterization, and therefore, no unique method for
detecting this GMO for the purpose of identification or traceability,
nor for addressing safety and liability issues that may arise.
The same EFSA dossier revealed that there are molecular changes at the
insertion site, specifically 40 bp of the host genome is missing from
GT73 while 22 bp of extraneous DNA of unknown origin is present at the
5’ junction of the insert. Nevertheless, these are considered not to
pose a safety risk, based solely on the lack of homology to known toxins
No molecular evidence of transgene stability
The transgenes were claimed by the company to be inserted in a stable
and Mendelian fashion. ISIS has pointed out more than once that this
claim of genetic stability - based on a failure to depart from
‘Mendelian ratios’ in the offpring generation - is not an acceptable
criterion of genetic stability in the absence of independent
ascertainment of the parental genotypes [8-13]. But EFSA has accepted
the same criterion of transgene stability. It stated : "The inserted
DNA is inherited in a stable fashion in a nuclear chromosome as
indicated by a number of parameters, e.g. predicted Mendelian
segregation ratios (over several generations) from crosses between GT73
and conventional oilseed rape."
Extensive changes in the codons of transgenes from native genes ignored
Few of the regulatory documents have dealt with extensive alterations in
the genetic codes of the native genes in the transgenes inserted into
GT73, but all of them acknowledge that the codes were altered to enhance
production of the bacterial gene products in the plant. The United
States Food and Drug Administration consultation on canola GT73 provided
a somewhat fuller description of the alterations in the bacterial DNA
 while the patent for the EPSPS used in canola GT73 provides an
extensive description of the code alteration . Native genes from
bacteria or humans do not function very well in crop plants because gene
expression is influenced by codon bias specific to plants, mammals or
bacteria. For that reason, the genetic code is altered by genetic
engineers to achieve optimum gene expression. The optimized transgenes
used in modified crops are mainly synthetic approximations of the real
bacterial gene . The synthetic genes are very different from the
genes that evolved in bacteria and for that reason their characteristic
recombination and mutation deserves special attention, as does its
toxicology and allergenic potential. However, these factors have been
largely ignored by the regulators.
Toxicology & allergenicity tests invalid
Even though the transgenes were altered in DNA sequence from the native
bacterial genes, the proteins actually tested for mammalian toxicity and
environmental safety were not isolated from GT73 but from the bacteria
. The bacterial surrogate enzymes were assumed to be identical to the
enzymes produced in GT73 by cursory observations using techniques such
as gel electrophoresis, N terminal analysis and enzyme activity, even
though the presence of four anomalous amino acids were noted in the
bacterial GOX . Digestibility and degradability were tested with the
bacterial proteins in simulated gastric fluid. And acute toxicity tests
in mice were similarly done with the bacterial proteins.
Allergenicity tests were even less reliable, as they depended on
theoretical evaluations based on assumptions that have been extensively
questioned. For example, the Austrian government, based on an analysis
of a number of applications for GMO approval in the EU, has concluded
that no direct testing of potentially allergenic properties of GM corps
and their products has been carried out . Instead, conclusion that
the protein in question is unlikely to exhibit allergenic properties is
largely based on the following theoretical considerations: the newly
introduced protein originates from a non-allergenic source; there is no
significant sequence homology to known allergens; the protein will be
rapidly digested in the intestine; the protein is not glycosylated; the
expression level of protein in the GM crop is low; and the protein is
not new to the human diet. The Austrian government has questioned each
of these arguments and their underlying assumptions in the light of
recent scientific data.
Consequently, these tests were neither meaningful nor valid. Empirical
tests should have been conducted at the very least, on the real proteins
isolated from GT73, not the bacterial surrogates.
The EFSA did include the warning that, "Since cross-reactivity between
GOX and tropomyosin is not ruled out completely, persons allergic to
shrimp meal should be aware of the possibility of hypersensitivity
reaction when working with GT73 oilseed rape."
Inadequate inappropriate feeding trials with unexplained adverse effect
According to the EFSA opinion , "A satisfactory explanation was
sought for the potentially adverse effect observed in one of the three
rat feeding studies." We believe that this refers to the concerns
expressed in regard to a confidential Monsanto feeding study that showed
that rats fed GT73 experienced a 15% increase in their liver weights.
The UK’s ACRE and ACAF (Advisory Committee on Animal Feedingstuffs) had
first raised concerns in March 2003 that the difference in the rats’
liver weights could not be explained, as volunteered by Monsanto, by
higher glucosinolate concentration in the GM diets compared with the
corresponding control diets . Subsequently, Monsanto provided further
information on this. But both ACRE and ACAF were "not satisfied" that
Monsanto had supported their hypothesis. They demanded a satisfactory
explanation for this potentially adverse response.
However, it appears that EFSA has dismissed those concerns. A list of
uninformative feeding trials was presented on various animals of
extremely short duration in which mostly body weights and sometimes,
liver weights were recorded. No histology was carried out. Because there
were no apparent gross pathological changes in the rat livers following
examination at necropsy, EFSA considered the difference in liver weights
an "incidental finding".
The regulatory reviews leading to commercialization of GT73 oilseed rape
without exception discounted the rapid pollution of transgenic crops by
wind spread pollen or by seed dispersal by animals or vehicles. This can
happen during transport, without planting in the field. Escaped seed can
germinate and potentially cross-pollinate with conventional oilseed
rape, feral populations and wild relatives. ACRE had also raised
concerns regarding seed spill, and was "not convinced that seed spill
will not occur and that feral populations will not materialise" .
There is clear and growing evidence that widespread deployment of GM
oilseed rape will lead to widespread contamination of conventional
crops. A 2003 report showed that 95% of certified seed stock in western
Canada were polluted to detectable levels with glyphosate tolerance
genes and 52% exceeded the allowable contamination of certified seed
. The widespread deployment of GM oilseed rape for a variety of
herbicides is leading to pyramiding of the genes for herbicide tolerance
, creating crops that turn into fertile weeds that are difficult to
Europe’s oilseed rape should keep its GM-free status before it too is
contaminated beyond redemption.
Agbios Data base product description MON-00073-7 (GT73, RT73) pp1-3
Canadian Food Inspection Agency Plant Biosafety Office Decision Document
DD95-02:Determination of of environmental safety of Monsanto Canada
Inc.’s Roundup Herbicide tolerant Brassica napus canola line GT73 1995,
Animal and Plant Health Inspection Service USDA Docket no. 98-089-2
Monsanto co. Determination of Nonregulated status for canola genetically
engineered for glyphosate tolerance 1999, pp1-33.
ACRE Advisory Committee on Releases to the Environment. Advice on a
notification for marketing of herbicide tolerant GM oilseed rape, 24
Opinion of the Scientific Panel on Genetically Modified Organisms on a
request from the Commission related to the Notification (Reference
C/NL/98/11) for the placing on the market of herbicide-tolerant oilseed
rape GT73, for import and processing, under Part C of Directive
2001/18/EC from Monsanto. The EFSA Journal 2004, 29, 1-19
"New Europe" blocks U.S. food import, Friends of the Earth Europe, 16
June 2004, http://www.foeeurope.org/press/2004/GR_16_june_US_food.htm
ANZFA Australia New Zealand Food Authority. Draft risk analysis report
application A363 Food produced from glyphosate tolerant canola line
GT73, 2002, pp1-73 http://www.agbios.com/docroot/decdocs/01-290-009.pdf
Ho MW and Cummins JC. GM food & feed not fit for "man or beast". ISIS
Report 29 April 2004
Ho MW. GM Science Review deeply flawed. Science in Society 2003, 19, 7-9.
Ho MW. GM maize approved on bad science. ISIS Report 25 February 2002;
also, Science in Society 2002, 15, 10-25.
Ho MW. Questionable stability at JIC. ISIS Report 2 March 2001
Ho MW. Letter to the Scottish Parliament Petitions Committee from ISIS.
28 February 2002.
Ho MW. GM rice unstable. ISIS News 9/10, July 2001.
US Food and Drug Administration Biotechnology Consultation Note to the
File BNF No.000020 Monsanto’s glyphosate tolerant canola line GT73 1995
Eicholtz D, Gasser D and Kishore G.
Glyphosate-tolerant-5-enopyruvyl-3-phosphoshikimate synthetase, 1999,
United States patent 5,866,775.
Cummins J. Synthetic genes in food crops, ISIS Press Release 1 September
Spök A, Hofer H, Lehner P, Valenta R, Stirn S, Gaugitsch H. Risk
assessment of GMO products in the European Union: Toxicity assessment,
allerginicity assessment and substantial equivalence in practice and
proposals for improvement and standardization, July 2004, Austrian
Federal Environment Agency Monograph.
Cummins J. Transgenic contamination of certified seed stocks, ISIS
Ho M. What lurks behind triple herbicide tolerant oilseed rape? ISIS
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