GENET archive


2-Plants: Stray seeds had antibiotic-resistance genes

                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  Stray seeds had antibiotic-resistance genes
SOURCE: Nature, by Colin Macilwain
DATE:   29 Mar 2005

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Stray seeds had antibiotic-resistance genes
Accidental release of genetically-modified crops sparks new worries.

Hundreds of tonnes of genetically modified corn seeds sold to farmers by
mistake over the past four years contained a gene for antibiotic
resistance, Nature has learned. The release of such genes into the
environment is sometimes considered inadvisable, as there is a small
chance that they could flow from crops to microorganisms and spread
problems of antibiotic resistance.

The Swiss biotechnology company Syngenta admitted last week that it had
accidentally released a variety of corn (maize) called Bt10 between 2001
and 2004. Like other crops with the name Bt, this corn had been
genetically modified to produce a protective pesticide. But Bt10 has not
been approved for sale by regulatory agencies.

Officials at the company last week argued that Bt10 is basically
identical to Bt11 corn, which has been approved for sale (see Nature 434,
423; 2005). But this week, Sarah Hull, a spokeswoman for Syngenta,
confirmed that a marker gene that confers resistance to ampicillin, a
commonly used antibiotic, was present in the Bt10 seeds. She adds that
this gene would not have been active in the corn plants that grew from
the seeds.

Antibiotic-resistance genes are widely used as 'tags' during the
production of genetically modified crops, to help breeders identify and
preserve desirable strains. But the genes are often removed before the
seeds enter the food chain. The presence of the marker gene in Bt10 corn
was noted in a 2003 advice notice from a UK government committee, the
Advisory Committee on Releases to the Environment, which was using Bt10
as a comparison to prove that there were no marker genes in Bt11 corn.

Critics have expressed surprise that neither Syngenta nor the US
Environmental Protection Agency (EPA) announced the presence of the
marker when they admitted that the release of Bt10 had taken place. "It
is quite scandalous," says Greg Jaffe, head of the biotechnology project
at the Center for Science in the Public Interest, a pressure group in
Washington DC. "This shows that the government and the company are not
being forthright."

Hull says that the company didn't mention the gene's presence because "it
wasn't relevant to the health and safety discussion". She adds that the
antibiotic-resistance genes have been around for a long time. "They've
been studied extensively, and they pose no risk to humans or animals,"
she says. Regulators say that the genes present a very small risk to
human health, either directly - if in the stomach of a patient on
antibiotics, for example - or indirectly through gene flow into microbes.

Michael Rodemeyer, director of the Pew Initiative on Food and
Biotechnology, a think-tank in Washington DC, says that the presence of
such genes would be unlikely to see a crop declared unsafe in the United
States - but adds that it could cause problems in Europe.

In a ruling published last April, for example, the European Food Safety
Authority, which advises European Union governments on food issues, said
that marker genes conferring resistance to ampicillin "should be
restricted to field trials and not be present in genetically modified
plants placed on the market". And the Codex Alimentarius Commission, the
international food-standards body, has urged the agricultural
biotechnology industry to use alternative methods to refine genetically
modified strains in the future.

The EPA, which is jointly investigating the release of the Bt10 corn with
the US Department of Agriculture, declined to say what it knew about the
antibiotic-resistance marker. "What the company told us and when about
the marker gene is part of our ongoing investigation and we are not able
to discuss it at this time," the agency said in a statement.

"I think they've done a terrible job," says Margaret Mellon, head of the
food and environment programme at the Union of Concerned Scientists in
Washington DC, referring to both Syngenta and the government agencies.
"There are lots and lots of unanswered questions, and the longer they
remain, the less confidence people are going to have in the technology
and in the regulatory system."

                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  DEFRA accused of key role in GM contamination cover-up
SOURCE: GM Free Cymru, UK
DATE:   30 Mar 2005

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DEFRA accused of key role in GM contamination cover-up

DEFRA (the UK Department for The Environment, Food And Rural Affairs) was
accused today of playing a key role in a spin-doctored cover-up designed
to protect the GM industry from the effects of the latest GM
contamination scandal. According to GM Free Cymru, the Government
Department rushed into print last week to protect the corporate giant
Syngenta, within 24 hours of receiving notification of the contamination
of maize supplies with the unauthorized variety Bt10.

The organization insists that the DEFRA press notice was inaccurate and
misleading, and contained statements which DEFRA must have known to be
untrue (1).

** The DEFRA statement stresses in several places that the contamination
incident was on "an extremely small scale". But GM Free Cymru points out
that by using Syngenta's own figures (2) it is clear that around 187,000
tonnes of contaminated maize has entered the food chain, and that
unauthorised GM material has been distributed on a massive scale. Some of
this material has been exported to Europe, but Syngenta refuses to
release details.

** DEFRA pretends that because USDA has concluded that there are no
safety concerns about the contamination incident, we should all come to
the same conclusion. What DEFRA does not say is that there is no
effective regulation of GM crops and foods in the USA, and that Bt 10
maize has never come before the authorities for assessment or regulation
either in the US or Europe (3). The DEFRA attitude is complacent and even

** DEFRA states that Bt10 maize "is covered by the existing tolerance
exemption for Bt11" and that it is virtually identical in its proteins.
This is a disingenuous and dangerous statement, since DEFRA and ACRE knew
as long ago as 2003 that Bt10 is unique and identifiable (4). It also
contains ampicillin antibiotic resistant marker genes, which makes it
illegal in Europe (5).

** DEFRA and ACRE are in possession of detailed technical data about Bt10
which they have refused, in spite of requests from a number of NGOs, to
place in the public domain. This information is not commercially
sensitive. We believe that since Bt10 was developed about ten years ago
by the Northrup-King company (later taken over by Syngenta) it has
changed its character and may be unstable. If this is the case, and if
Bt10 really is a "failed" variety, DEFRA should be taking steps to
protect the public instead of taking steps to protect Syngenta.

Speaking for GM Free Cymru, Dr Brian John said: "It is well known that
one of DEFRA's policy objectives is the promotion of GM crops and foods
against the clearly-expressed wishes of the British public. But in
rushing to "damp down" speculation about the extent of Bt10
contamination, and any associated health dangers, it has danced to
Syngenta's tune and has failed in its duty of care. Has DEFRA not learned
anything from the BSE disaster and the F&M disaster? We may now have
maize products on our supermarket shelves that contain antibiotics, and
our Government appears to be quite disinterested."


Contact: Dr Brian John Tel +44-1239-820470


(1) DEFRA Press Release, 23 March 2005 (see below)

(2) Press Release: Following Syngenta-initiated investigation of
unintended corn release, EPA and USDA conclude existing food safety
clearance applies, no human health or environmental concerns ,
Washington, DC (USA), 21 March 2005, Syngenta web site.

GM Maize imported into Europe had no US or EU approval Press Notice from
GM Free Cymru, 24 March 2005 Seven packages of information about Bt10
were submitted to EPA between Jan 7th and March 10th 2005; these were
reviewed, and EPA then confirmed the Syngenta view that there was no risk
associated with the releases of Bt10 into the environment and the food
chain. There appear to have been no laboratory analyses of Bt10 maize
either by EPA, USDA or FDA.

(4) We now know that the differences between the Bt10 and Bt11 varieties
were so significant that the former was used as a 'control' to establish
the distinctiveness of the latter. If these differences had not been
established, Bt11 would never have been given approval in Europe. See
ACRE advice as follows:
In the Syngenta press release, the company said that the Bt protein
produced by the Bt10 breeding lines is identical to that produced by the
commercialized, fully approved Bt11 varieties. They claimed, on this
basis, that there is no change to the food, health and environmental
profile of the corn. In the view of GM Free Cymru this is a fraudulent

(5) According to FoE Europe, the Advisory Committee on Releases to the
Environment (ACRE) notes that Bt10 contains one or more copies of the
ampicillin resistance marker gene (beta lactamase), which is not present
in Bt11. This therefore makes Bt10 a very different GMO than Bt11. Since
ampicillin is a widely used clinical antibiotic, and EFSA, Codex
Alimentarius, FAO-WHO and many medical and scientific experts have
recommended against the use of genes for such antibiotics in GM foods, it
would certainly not be licenced in the EU.


                                  PART III
-------------------------------- GENET-news -------------------------------

TITLE:  Syngenta: Incompetent science covered by public relations smokescreen
SOURCE: Greenpeace International, Media Advisory
DATE:   31 Mar 2005

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Syngenta: Incompetent science covered by public relations smokescreen

Greenpeace response to:
- Article in Nature magazine published on 24 March 2005 in which Syngenta
admitted to a case of GE maize (Bt10/Bt11) contamination.
- Article in Nature Biotechnology magazine published on 27 March 2005 in
which Syngenta released the 'latest research' on GE Golden Rice.
- Article in Nature magazine published on 31 March confirming that the
Syngenta Bt10 GE maize contains an antibiotic resistance marker gene.

Amsterdam. 31 March 2005 -- Syngenta has attempted to deliberately mislead
the public with their admission of GE maize (Bt10) contamination
published last week when they neglected to include, amongst many other
relevant facts, that the Bt10 contained an antibiotic resistance marker

Last week Syngenta declared that "what makes this somewhat unique is that
Bt10 and Bt11 are physically identical and the proteins are identical".
This week following research and complaints by NGOs and others, the
information was to give forth that Bt10 contains an antibiotic resistance
marker gene that provides resistance to ampicillin.

Ampicillin is an important antibiotic widely used to treat human and
animal infections. The European Community's 2001/18 directive[ii]
requires the phasing out of such antibiotic resistance marker genes
(which may have adverse effects on human health and the environment) in
GMOs by the end of 2004. Even the European Food Safety Authority
(EFSA)[iii], which is rarely critical of GMOs state that this type of
antibiotic "should not be present in GM plants to be placed on the
market" (EFSA, 2004).

Lindsay Keenan Genetic Engineering campaigner for Greenpeace: "It is
unbelievable that Syngenta after 4 months of preparation for releasing
this information should say that these GE crops are physically identical
when one contains an antibiotic resistance marker gene and one does not."

This Bt10 / Bt11 contamination case exposes the basic unpredictability of
GMOs, the incompetence of Syngenta to handle GMO seeds safely, the
complete lack of regulatory controls in the US, and the lack of
implementation of controls in the EU. It also exposes the disgraceful
attempts of GE companies like Syngenta to cover-up the bad science with a
smokescreen of public relations and media management.

Greenpeace has a number of questions regarding this GE maize (Bt10/Bt11)
contamination including:

- Why hasn't Syngenta released a testing protocol for Bt10 yet?

- According to the Nature report, Syngenta has said the antibiotic marker
gene is not active in Bt10. On what evidence is this based?

- What food and environmental safety testing has been performed? Why
haven't the results of any such testing been released?

- What volume of BT11 has been contaminated by the Bt10? In which
countries has it been sold during the last 4 years?

- What testing is the company now doing to ensure that no BT10 is present
in food products? What action is the company taking to recall
contaminated food products?

- Will the company be paying costs for any losses suffered due to the

Golden Rice - propaganda for the GE industry

The same company that has acted less than honestly over this scandalous
contamination incident is also developing the so-called "Golden Rice",
whose latest research results were coincidently revealed in Nature
Biotechnology on 27th March.

The so-called "Golden Rice" is genetically engineered (GE) to produce
pro-Vitamin A but is technically insufficient to solve the problem of
vitamin A deficiency. Despite this, it is promoted as a cure for dietary
Vitamin A Deficiency, which affects over 250 million people around the
world. In fact, Golden Rice is distracting attention and funding away
from better and more sustainable solutions that already exist.

The new generation of Golden Rice is very far away from actually
demonstrating that it has a real potential to alleviate dietary Vitamin A
Deficiency (VAD). All Syngenta have done is to elevate the beta-carotene
(pro-vitamin A) concentration in the GE rice.

There are still many factors with this GE rice that have not been
addressed. For example, losses of beta-carotene on cooking and storage
have not been quantified. The bioavailability (real uptake into the human
body) of this pro-vitamin A is unknown. Several scientists have discussed
that this Golden Rice is a technological fix that is unlikely to work.
Vitamin A deficiency is a complex problem, often associated with other
vitamin and mineral deficiencies.

After five years of research there are still no answers to questions of
safety for the environment and consumers. Over the same period of time,
several other approaches to solve VAD have been shown to work
efficiently, but to completely solve VAD, what is needed is political
support. The Golden Rice project continues to distract public awareness
from other real working solutions such as vitamin A supplementations and
home gardening incentives. The real solution is a diverse diet.

Greenpeace campaigner Keenan continued: "It appears to be quite clear by
now that Golden Rice is a research project designed to promote the GE
industry in an attempt to make their current environmentally
contaminating GE crops more acceptable to consumers and the media rather
than any genuine attempt to solve the VAD problem".

For more information:
Lindsay Keenan, genetic engineering campaigner, Greenpeace +31 646 162 029
Judit L. Kalovits, media officer, Greenpeace +31 621 296 914

See Greenpeace website for more news


[i] ACRE 2004. Advice on a notification for marketing of insect resistant
and herbicide tolerant GM maize, C/F/96/05/10 4th February 2004.

[ii] Directive 2001/18/EC of the European Parliament and of the council
of 12 March 2001on the deliberate release into the environment of
genetically modified organisms and repealing Council Directive 90/220/EEC

[iii] EFSA 2004. Opinion of the Scientific Panel on Genetically Modified
Organisms on the use of antibiotic resistance genes as marker genes in
genetically modified plants. (Question N° EFSA-Q-2003-109). The EFSA
Journal 48: 1-18.

                                  PART IV
-------------------------------- GENET-news -------------------------------

TITLE:  Opinion adopted by the GMO Panel on 2 April 2004
SOURCE: European Food Safety Authority
DATE:   16 Apr 2004

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Opinion adopted by the GMO Panel on 2 April 2004

Opinion of the Scientific Panel on Genetically Modified Organisms on the
use of antibiotic resistance genes as marker genes in genetically
modified plants. (Question N° EFSA-Q-2003-109)


Directive 2001/18/EC (EC, 2001) states that Member States and the
Commission shall ensure that GMOs which contain genes expressing
resistance to antibiotics in use for medical or veterinary treatment are
taken into particular consideration when carrying out an environmental
risk assessment. This is with a view to identify and phase out antibiotic
resistance marker genes (ARMGs) in GMOs which may have adverse effects on
human health and the environment.

The Scientific Panel on genetically modified organisms (GMO Panel) of the
European Food Safety Authority (EFSA) has evaluated the potential risks
associated with specific ARMGs taking into account their current usage in
clinical and veterinary medicine, the likely occurrence of horizontal
gene transfer from genetically modified (GM) plants to microbes and the
potential impact of horizontal gene transfer where naturally occurring
resistance to the relevant antibiotics exists in the microbial gene pool.
These factors will impact on the likelihood of any adverse effects on
humans or the environment of ARMGs used in GM plants.

The GMO Panel considers the frequency of horizontal gene transfer from GM
plants to other organisms as very low for all ARMGs considered. This, in
itself, is an important consideration with regard to any risk posed by
the use of ARMGs. However, with respect to clinical importance the Panel
has categorised ARMGs into three groups with different potentials for
compromising human health and the environment. ARMGs in the first group
include genes conferring resistance to kanamycin and hygromycin. In this
group the nptII gene, which confers kanamycin resistance, has a 13-year
history of safe use in food crops and resistance to this group of
antibiotics is widespread in naturally occurring microbes in humans and
the environment. The Panel is of the opinion that with regard to safety
there is no rationale for inhibiting or restricting the use of genes in
this category, either for field experimentation or for the purpose of
placing on the market. The second group of ARMGs, which includes
resistance to chloramphenicol, ampicillin, streptomycin and
spectinomycin, should be restricted to field trial purposes and should
not be present in GM plants to be placed on the market. Given their
current importance in clinical usage, the GMO Panel recommends that ARMGs
placed in the third group, which includes those conferring resistance to
amikacin and tetracyclines, are not present in GM plants to be placed on
the market or in plants used for experimental field trials.


European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
In den Steinäckern 13
D - 38116 Braunschweig

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