GENET archive


2-Plants: Update on BT10 contamination

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

TITLE:  Test likely to bring end of ban on USA corn gluten
SOURCE: Illinois Farm Bureau, USA, by Philip Clarke
        posted by, Switzerland
DATE:   22 Apr 2005

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Test likely to bring end of ban on USA corn gluten

EUROPE'S NEW trade ban on imports of US corn gluten feed and distillers'
grains is likely to be short-lived, after the development of a new test for
the unapproved GM maize variety, Bt10.

The de facto ban came into force this week, with the EU Commission requiring
all imports of the two feed ingredients from the USA to be certified as
"Bt10-free". This followed the revelation that several hundred tonnes of
the unapproved Bt10 seed has been accidentally sold to US farmers over the
past four years and some of this was then exported to the EU.

"This [certification] is a targeted measure, necessary to uphold EU law,
maintain consumer confidence and ensure that the unauthorised Bt10 cannot
enter the EU," said food safety commissioner Markos Kyprianou. "We cannot
allow a GMO which has not been through our rigorous authorisation
procedures to enter the EU market."

Green lobby group Friends of the Earth was quick to applaud the move,
suggesting that, with no reliable test, it would result in a de facto ban
on imports of US maize-based animal feeds.

But Syngenta, the biotech company behind the GM maize, has since confirmed
it has developed a new test able to detect the smallest traces of Bt10 in
bulk animal feed. "We have shared this information with Brussels and it
could be put in place at US ports within a few days," said company
spokesman Markus Payer. "The impact on trade should be minimal," he added.

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

TITLE:  U.S. in Biotech-Food Fight With Rest of World --- Mistaken Exports
of Corn Raise Concerns as Europe Imposes Import Controls
SOURCE: Dow Jones Newswires, by Victoria Knight / The Wall Street Journal,
DATE:   21 Apr 2005

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U.S. in Biotech-Food Fight With Rest of World --- Mistaken Exports of Corn
Raise Concerns as Europe Imposes Import Controls
BRUSSELS -- Europeans are furious. Japanese and South Koreans are concerned.
Americans are unperturbed.

The varying reactions to U.S. exports of Bt10, a type of genetically
modified corn mistakenly sold without regulatory approval by Swiss
agrochemicals company Syngenta AG to U.S. farmers, underscore stark
differences in consumer attitudes toward biotech foods.

Governments and regulators around the globe are clamoring to put in place
new controls in order to calm consumer fears -- and are likely to be
successful in this case. But European fears and Japanese and South Korean
concerns are likely to continue causing frictions because the case exposes
errors by a big biotechnology company as well as weaknesses in U.S.
regulatory controls and the inability of regulators in the importing
countries to detect the presence of genetically modified products.

Yesterday, the European Union -- as it said it would last week -- imposed
controls on U.S. imports of corn gluten and brewer's grain, types of animal
feed that the EU says are most likely to be contaminated.

Syngenta mistakenly sent Bt10 seeds to researchers in France and Spain. The
crops have since been destroyed. In addition, around 1,000 metric tons of
Bt10 for consumption by both animals and humans, valued at around 443
million euros in annual imports, are thought to have entered the EU's food
chain during the past four years, according to the European Commission.

Last week, it looked as though the Bt10 case could spark another trade row
after the U.S. branded the EU's plans an "overreaction." EU Health and
Consumer Protection Commissioner Markos Kyprianou flew to the U.S. on
Sunday to damp mounting tensions. On Monday he met with U.S. Food and Drug
Administration Commissioner Lester Crawford and U.S. Department of
Agriculture Secretary Mike Johanns. Mr. Kyprianou assured the U.S. that
disruption would likely to be kept to a minimum because a test for Bt10 is
likely to be available soon allowing importers to meet the new tougher
import criteria, according to EU officials.

U.S. consumers appear unfazed by the thought that they may have consumed
some products containing Bt10 -- corn is used to make sweeteners in sodas,
for example -- because it is considered safe by U.S. authorities.

But Europeans remain skeptical about biotech foods. Food scares such as
mad-cow disease in beef and revelations about chicken and pork contaminated
with poisonous dioxins have made many Europeans distrustful of the ability
of national governments and EU regulators to provide adequate information
and protection. For six years, the EU imposed a moratorium on new biotech
food and animal feed. That ban ended last May when the European Commission
approved a strain of sweet corn developed by Syngenta.

Three weeks ago Syngenta told U.S. regulators it had mistakenly sold Bt10
seeds to farmers in four U.S. states, thinking they were Bt11 seeds. The
majority of grain grown is used for animal feed and as feedstock for
industrial processes. Only a small portion is used for human consumption as
cereals, sweeteners and thickening agents for food such as sauces.

The U.S. Department of Agriculture has fined Syngenta $375,000 (287,663
euros) and ordered it to destroy any remaining stocks of the product. All
plantings in the U.S. and seed stock have been identified and either
destroyed or quarantined for future destruction. No Bt10 will be grown in
the U.S. in 2005.

The USDA also said that, in its opinion, the product poses "no hazards to
health, safety or the environment." The U.S. regulator bases its analysis
on the fact that the protein in Bt10 is similar to the one in Bt11, which
is fully authorized for feed and food in the EU, Asia and the U.S.

The EU, however, said it was concerned about Bt10 particularly after
Syngenta revealed that, unlike Bt11, it contains a gene that can make that
strain of corn resistant to ampicillin, a commonly used antibiotic. U.S.
authorities didn't immediately share this information with the European
Commission, which irked the EU. Sygnenta says that the gene poses no

The commission has no power to fine Syngenta, but EU law requires it to
prevent unauthorized genetically modified products from entering Europe.

The measures that went into effect yesterday require companies to prove that
consignments of the two products are free of Bt10 corn before they can be
sold in any of the 25 EU member states. As yet there is no evidence that
the Bt10 has entered the human food chain in Europe.

The new controls will remain until a detection test for Bt10 is devised and
approved by EU regulators. The U.S. has said it hopes this will happen by
the end of next week. In the meantime, the EU is continuing to allow
consignments of U.S. corn to be unloaded at its docks.

The corn confidence crisis also is affecting U.S. exports to other nations.
South Korea is requiring importers to certify that U.S. food-grade corn
doesn't contain Bt10. Japan is trying to find out how much Bt10, if any,
may have entered its market before it responds. "We will take appropriate
measures if we find evidence that Bt10 has been imported," said a Japanese
diplomat, adding that this would likely take a similar form to the EU's

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

U.S. [1]
DATE:   19 Apr 2005

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Dear friends and colleagues,


European Union member states voted, on 15 April, to restrict US shipments of
suspect corn imports unless it was assured that the shipments are free of
the experimental and unauthorized genetically engineered (GE) corn, Bt10.
Imports of corn products which are certified as free of Bt10 will be

The EU, like many countries around the world, has zero tolerance for
unapproved GMOs. The unapproved Bt10 was mistaken for Bt11, which is
approved in some countries.

Between 2001 and 2004, Syngenta had inadvertently produced and distributed
Bt10 (see BIS 5 April 2004). An estimated 1000 metric tonnes of Bt10
products may have entered the EU through Bt11 export channels since 2001.
Other countries that import corn from the US may also have received Bt10.

Syngenta later admitted that a marker gene that confers resistance to
ampicillin, a commonly used antibiotic for treating human and animal
infections, is present in Bt10 (see BIS 28 March 2005).

The EU's Standing Committee on the Food Chain and Animal Health considered a
draft European Commission Decision which introduced legally binding
emergency measures that require imports of corn gluten feed and brewers
grain from the US to be certified as free of Bt10. These are the imported
products considered most likely to be contaminated.

EU member states voted almost unanimously to adopt the draft decision. 22 of
the 25 EU countries voted in favour, while Hungary abstained, and Lithuania
and Malta were not present at the meeting.

Consignments of corn gluten feed and brewers grain from the US can now only
be placed on the EU market if they are accompanied by an original
analytical report issued by an accredited laboratory which demonstrates
that the product does not contain Bt10. In the absence of such a report,
the importing company must either have the corn tested or not place it on
the market.

The EU said that given the failure of Syngenta or the US authorities to
deliver the data necessary for a full safety assessment of Bt10, such
"emergency measures" are required "in order to achieve the high level of
health protection chosen in the Community".

The measures also call on EU member states to conduct spot checks of their
GE corn imports, a process that is waiting on Syngenta's release of the
full information about the molecular characterization of Bt10 and its
distinction from Bt11, as well as the specific detection method to trace

The EU recognizes that the measures should be "no more restrictive of trade
than is required", and thus limits the conditions only to corn feed and
brewers grains given that the US has provided assurances that apart from
those products, neither GE corn grain nor any product derived from this are
imported into the EU from the US. Furthermore, no GE corn imported from the
US is used in the production of food in the EU. Making the measures no more
trade-restrictive than required ensures compliance with WTO rules.

We urge countries that may have potentially received Bt10 to require similar
assurances that their corn imports from the US are free from Bt10.

Currently, in the absence of the Bt10-free certification, the importing
company in the EU will have to either test the shipment or not place it on
the market. For many developing countries, it will be difficult and costly
to test incoming shipments from the US.

By requiring the exporter to provide a report issued by an accredited
laboratory showing that a shipment does not contain Bt10, this ensures that
the burden of proof falls on the exporter. In addition, countries should
insist that Syngenta sets up a compensation fund to pay for the testing of
corn products worldwide. Testing may still be necessary on the importing
country side to verify results.

In any case, the Bt10 incident highlights the urgent need for international
norms to require segregation and testing of GE commodities before export,
by GE producers and exporters, in order to ensure that GE-free shipments
are maintained and that any unapproved GMOs are detected before shipment,
to avoid disruption to trade.

A clear system for traceability must also be in place to ensure monitoring
and surveillance, and to enable product recalls of an unapproved GMO, if
necessary. Detection methods and the necessary reference materials should
be provided by GE developers, including for experimental GMOs, to enable
detection and identification.

Segregation would also facilitate clear, unambiguous and detailed
identification of GMOs in accompanying shipping documents, as desired by
most importing countries. These issues are currently discussed under
Article 18.2(a) of the Cartagena Protocol on Biosafety, but are contentious
because GE producing and exporting countries simply want the documents to
state that the shipment "may contain" LMOs (living modified organisms, a
term used in the Protocol).

Such ambiguous identification standards will not require segregation and
thus will not help at all in case another unapproved GMO enters export
channels. Clear identification, including documents that state that a
shipment contains GMOs, and full information about its identity, including
common, scientific and commercial names, transformation event codes and any
unique identifier codes, means that the burden to segregate and test GMOs
will fall on the exporter, not importing countries, and that any unapproved
GMO would more likely be detected before export.

We attach below the draft Decision of the European Commission that was
approved by EU member states with slight amendments. Relevant press
articles related to the decision will be sent in a separate mail-out.

With best wishes,

Lim Li Ching
Third World Network
121-S Jalan Utama
10450 Penang

REF: Doc.TWN/Biosafety/2005/J



of [...]

on emergency measures regarding the non authorised genetically modified
organism "Bt10" in maize products

(Text with EEA relevance)

Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority
and laying down procedures in matters of food safety[1], and in particular
Article 53(1) thereof,

(1) Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003[2] on
genetically modified (GM) food and feed provide that no genetically
modified food or feed shall be placed on the Community market unless it is
covered by an authorisation granted in accordance with that Regulation.
Articles 4(3) and 16(3) of the same Regulation lay down that no GM food and
feed shall be authorised unless it has been adequately and sufficiently
demonstrated that it does not have adverse effects on human health, animal
health or the environment, that it does not mislead the consumer or the
user, and differ from the food or feed it is intended to replace to such an
extent that its normal consumption would be nutritionally disadvantageous
for humans or animals.

(2) On 22 March 2004, the authorities of the United States of America (the
US authorities) informed the Commission that maize products contaminated
with the genetically modified organism called "Bt10" (the contaminated
products), which have not been authorised for placing on the market in the
Community, were likely to have been exported to the Community since 2001
and to continue to be exported. In addition, these authorities informed the
Commission that those products were not authorised for placing on the market
in the United States of America either.

(3) Without prejudice to the control obligations of the Member States, the
measures to be adopted further to the likely imports of contaminated
products should be subject to a comprehensive and common approach allowing
rapid and effective action to be taken and avoiding disparities between
Member States in the treatment of the situation.

(4) Article 53 of Regulation (EC) No 178/2002 provides for the possibility
to adopt appropriate Community emergency measures for food and feed
imported from a third country in order to protect human health, animal
health or the environment, where the risk can not be contained
satisfactorily by means of measures taken by the Member States concerned.

(5)  Although the contamination of products was reported by Syngenta, which
is the company developing the genetically modified maize "Bt10", to the US
authorities in December 2004, no data enabling a safety assessment of the
genetically modified maize "Bt10" by the European Food Safety Authority
(the Authority) according to the standards laid down in Regulation (EC) No
1829/2003 were provided by Syngenta or the US authorities. According to the
Authority[3], in the absence of this information, the safety of "Bt10" has
yet to be confirmed.
(6) Considering the absence of sufficient data enabling a safety assessment
of the genetically modified maize "Bt10" in order to achieve the high level
of health protection chosen in the Community, and the presumption of risk on
products not authorised according to Regulation (EC) No 1829/2003, which
takes into account the precautionary principle laid down in Article 7 of
Regulation (EC) No 178/2002, it is appropriate to take emergency measures
in order to prevent the placing on the market in the Community of the
contaminated products.

(7) According to the general requirements laid down in Regulation (EC) No
178/2002, food and feed business operators have primary legal
responsibility for ensuring that foods or feeds within the businesses under
their control satisfy the requirements of food law and for verifying that
such requirements are met. The duty to prove the absence of placing on the
market of the contaminated products should therefore rely on the
responsible operator. To this end, the emergency measures should require
that consignments of specific products originating from the United States
of America may be placed on the market only if an analytical report proving
that the products are not contaminated with the genetically modified maize
"Bt10" is provided. The analytical report should be issued by an accredited
laboratory according to internationally recognised standards.
(8) In order to facilitate controls, all genetically modified food and feed
placed on the market should be subject to a validated method of detection.
Syngenta has been requested to provide the method for the event-specific
detection of the genetically modified maize "Bt10" as well as control
samples. Consequently, the Community reference laboratory referred to in
Article 32 of Regulation (EC) No 1829/2003 (the CRL) has been asked to test
the detection method for this product on the basis of data provided by
Syngenta. The detection method is made available by Syngenta and can also
be found at the following address:

(9) Considering that the measures provided for in this Decision must be
proportionate and no more restrictive of trade than is required, only
products considered as the most likely contaminated with genetically
modified maize "Bt10" should be covered. According to the information
received from the US authorities, neither genetically modified maize grain
nor any product derived therefrom are imported from the United States of
America to the Community, with the exception of corn gluten feed and
brewers grains for feed use. Accordingly, the latter products should be the
subject of the said measures.
(10) Despite requests made by the Commission, the US authorities were not in
a position to provide any guarantee on the absence of "Bt10" in corn gluten
feed and brewers grains containing or produced from genetically modified
organisms, which are imported in the Community, considering the lack of
segregation or traceability measures in the United States of America on
these products.

(11) With regard to food products, according to the information made
available to the Commission, no genetically modified maize imported from
the United States of America is used in the production of food in the
Community. Member States should however monitor whether genetically
modified maize food products are present on the market and whether these
have been contaminated by "Bt10". On the basis of the information provided
by Member States, the Commission will consider the need of any appropriate
(12) These measures should be evaluated at the latest after 6 months in
order to assess whether they are still necessary.

(13) The measures provided for in this Decision are in accordance with the
opinion of the Standing Committee on the Food Chain and Animal Health,

Article 1
This Decision applies to the following products originating from the United
States of America:
- corn gluten feed containing or produced from genetically modified maize
within CN code 2309 9020
- brewers grains containing or produced from genetically modified maize
within CN code 2303 3000.

Article 2
Conditions for first placing on the market
1. Member States shall allow the first placing on the market of the products
referred to in Article 1 only where an original analytical report issued by
an accredited laboratory accompanying the consignment proves that the
product does not contain "Bt10" maize or feed produced from "Bt10" maize.

2. In the absence of such an analytical report, the operator established in
the Community who is responsible for the first placing on the market of the
product shall have the products referred to in Article 1 tested to prove
that they do not contain "Bt10" maize or feed produced from "Bt10" maize.
Pending availability of the analytical report, the consignment shall not be
placed on the market of the Community.
3. Member States shall inform the Commission of positive (unfavourable)
results through the Rapid Alert System for food and feed.

Article 3
Other control measures
Member States shall take appropriate measures, including random sampling and
analysis, of he products referred to in Article 1 already on the market in
order to verify the absence of "Bt10" maize or feed produced from "Bt10"
maize. They shall inform the Commission of positive(unfavourable) results
through the Rapid Alert System for food and feed.

Article 4
Contaminated consignments
Member States shall take the necessary measures to ensure that the products
referred to in Article 1 that are found to contain "Bt10" maize or feed
produced from "Bt10" maize are not placed on the market.

Article 5
Recovery of costs
Member States shall ensure that the costs incurred in the implementation of
Articles 2 and 4 are borne by the operators concerned.

Article 6
This Decision is addressed to the Member States.

Done at Brussels,
For the Commission
Markos Kyprianou
Member of the Commission
[1] OJ L 31, 1.2.2002, p. 1.
[2] OJ L 268, 18.10.2003, p. 1.
[3] Statement of the European Food Safety Authority issued on 12 April 2005.

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

TITLE:  German consumer protection minister:
SOURCE: Der Spiegel, Germany
        posted by, Switzerland
DATE:   19 Apr 2005

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German consumer protection minister:

Renate Kuenast, Germany's consumer protection minister, says Europe had no
choice but to ban genetically modified corn from the United States because
American farmers have no system in place for labeling GMOs and tracing them
back to their producers.

SPIEGEL: Ms. Kuenast, last Friday the European Union decided that no
genetically modified corn from the US can enter Europe anymore. What about
the ships that are anchoring in front of Rotterdam? Can they still be

Kuenast: No. Nobody will accept their cargo right now. It's about setting a
precedence. The action is the only possible way of dealing with an
unbelievable sloppiness -- the mixing of different genetically modified
corn families. The so-called Bt10 corn from the US, with its resistance
against the antibiotic Ampicillin is neither permitted in the US nor in
Europe. The EU has not banned all US corn imports. It is merely demanding
proof that the imported corn products do not include any Bt10.

SPIEGEL: ... which the Americans are unable to provide.

Kuenast: That's a problem. In the US, unlike Europe, genetically-modified
food isn't labelled and it can't be traced back to the producer. This
deficiency is a stumbling block in cases like this. There is a lack of

SPIEGEL: US agricultural corporations are now threatening to sue for
billions in damages. Isn't the measure excessive?

Kuenast: The Europeans, and especially we Germans, have also learned out
lesson. Think of the BSE (mad cow disease) scandal or foot-and-mouth
disease. They cost farmers and the EU billions. And as a consequence we
introduced transparent rules both in Berlin and Brussels that are easy to
monitor. Ever since, consumer protection has had top priority.

SPIEGEL: But couldn't it be that you want to force the world to adopt your
rigid position on agricultural genetic engineering. According to estimates
of the German Economics Ministry, this position comes at the expense of
both know-how and jobs.

Kuenast: It's quite the contrary. Organic farming has already created
150,000 jobs in Germany alone. A study by Ernst & Young showed that there
are only 2,000 jobs in the sector of agricultural genetic engineering. And
our clear-cut requirements -- security, labeling, and traceability -- have
already created an economic advantage, especially in the export sector.
Throughout the world, consumers are weary of genetically modified products.
Producers know this. For many, abstaining from these products is already
paying off.

SPIEGEL: The US are going to fight the Brussels decision. What do you think
the outcome will be?

Kuenast: I do acknowledge that the decision is a challenge for the US. But I
do not believe that a solution lies in imposing further trade restrictions.

SPIEGEL: US diplomats have indirectly threatened in recent days and weeks
that there could be an escalating trade war.

Kuenast: I would not phrase it that way.

SPIEGEL: Then how would you phrase it?

Kuenast: The Americans were very committed on the issue. They wanted to
change our mind, but, as you can see, without success.

SPIEGEL: So you expect the US to follow Germany's fixation with the

Kuenast: Rubbish. To begin with, this is a European measure, not a German
one. And US corn exporters have to comply with EU rules just as European
exporters have to comply with US rules. But I do believe that America will
start discussing whether the current lax position on genetically modified
foods is still maintainable.

                                  PART V
------------------------------- GENET-news -------------------------------

TITLE:  EU certified needed, or banned—US outraged
SOURCE: Reuters, by Jeremy Smith
DATE:   18 Apr 2005

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EU certified needed, or banned—US outraged

BRUSSELS - Europe and the United States crossed swords on Friday after EU
experts blocked imports of US maize animal feed and grains unless there is
proof they are untainted by an illegal genetically modified organism (GMO).

The United States, which has challenged EU biotech policy at the World Trade
Organisation, called the move an over-reaction.

>From next week, US exports to Europe of corn gluten feed and brewers grains,
a by-product of ethanol, must be certified by an internationally-accredited
laboratory to show there is no presence of Bt-10 maize, a GMO that is not
authorised in Europe.

These measures will be reviewed at the end of October. US exporters send 3.5
million tonnes of corn gluten feed to Europe each year, a trade worth some
350 million euros ($449 million).

"Imports of maize products which are certified as free of Bt-10 will be able
to continue, but at the same time we cannot and will not allow a GMO which
has not gone through our rigorous authorisation procedures to enter the EU
market," EU Health and Consumer Protection Commissioner Markos Kyprianou

Last month Swiss agrochemicals group Syngenta said some of its maize seeds
sent to the EU from the United States were mistakenly mixed with Bt-10.
This insect-resistant strain is similar to Bt-11, a different GMO strain
that won EU approval for distribution in 1998.

Syngenta said it respected the Commission's decision "to ensure compliance
with the existing regulations".

"We are fully committed to continue co-operation with all concerned
parties," Mike Mack, chief operating officer of Syngenta Seeds, said in a

"We will make operational within a matter of days a valid test method to
detect for Bt10," Mack said. Such a test would still need further approval
from E.U. authorities. It was not immediately clear how long such approval
would take.


In Europe, consumers have been far more reluctant than in the US to accept
GMO products, often dubbed as "Frankenstein foods", while manufacturers of
GMO foods insist they are safe.

US officials condemned the EU move.

"We view the EU's decision to impose a certification requirement on US corn
gluten due to the possible, low-level presence of Bt-10 corn to be an
over-reaction," said Edward Kemp, spokesman at the US mission to the
European Union.

"US regulatory authorities have determined there are no hazards to health,
safety or the environment related to Bt-10," he said. "There is no reason
to expect any negative impact from the small amounts of Bt-10 corn that may
have entered the EU."

The maize mix-up occurred sometime between 2001 and 2004.

Small amounts of seeds, up to 10 kilograms, arrived in France and Spain from
US suppliers for research purposes. All the seeds have since been destroyed.

Some 1,000 tonnes of Bt-10 maize also entered the EU as food and animal feed
but it is still not clear to which countries. Around 70 percent of this is
thought to be animal feed.

Green groups said the decision amounted to an effective ban on imports of US
maize-based feeds for the foreseeable future.

"Today's emergency measures will be unpopular with the US government and the
biotechnology industry but will start to protect Europe from more
contaminated products," said Adrian Bebb at Friends of the Earth Europe.

                                  PART VI
------------------------------- GENET-news -------------------------------

TITLE:  US sent banned corn to Europe for four years
SOURCE: The Independent, UK, by Geoffrey Lean
DATE:   17 Apr 2005

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US sent banned corn to Europe for four years

All imports of United States corn have been stopped at British ports
following the discovery that the US has been illegally exporting a banned
GM maize to Europe for the past four years.

The unprecedented move, which has angered the Bush administration, follows
efforts to hush up and play down the scandal on both sides of the Atlantic.

For weeks the official food watchdog failed to look for imports of the
maize, which is banned on health grounds. It has been forced to take action
by the European Commission.

The two main opposition parties yesterday blamed the delay on a pro-GM and
pro-US bias in the Food Standards Agency, and pledged to correct it if they
came to power.

The scandal - the worst yet involving GM imports - centres around maize
named Bt 11, modified to repel a pest called the corn borer. It also
contains a gene conferring resistance to antibiotics. All such crops are
banned in Europe because of fears that the resistance could spread to
consumers via the food chain.

Syngenta, the biotech company that developed the maize, told the US
government last December that the crop had been grown over 37,000 acres of
the country since 2001, because it had been confused with a similar,
approved, maize. It was fined $375,000 (£200,000) for the blunder.

But the Bush administration failed for three months to inform European
customers that they were importing a banned maize. The scandal was admitted
only after it was exposed by the scientific magazine Nature, on 22 March.
Even then the US failed to mention that the maize contained the gene for
antibiotic resistance.

Europe is estimated to have imported about 1,000 tons of the banned maize,
as animal feed. The EC says it cannot eliminate danger to people who
consumed meat or dairy products from livestock. It has no idea where in
Europe the banned maize has gone or whether the US stopped exporting it.

The Department for Environment, Food and Rural Affairs said only "very
small" amounts of maize were involved, echoing a statement from Syngenta,
and there was "no actual indication" any had ended up in the UK.

The Food Standards Agency refused pleas to try to identify the maize in
Britain. Its import was stopped on Friday and supplies in transit are being
tested at the ports.

                                  PART VII
------------------------------- GENET-news -------------------------------

TITLE:  Don't rely on Uncle Sam
SOURCE: Nature 434: 807
DATE:   14 Apr 2005

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Don't rely on Uncle Sam

European regulators should pursue their own investigation into how the
'wrong' genetically modified corn was allowed on the market for years.
Unfortunately, their US equivalents show little sign of rising to the

Given widespread unease among the European public about genetically modified
crops, you'd have expected the news that unapproved batches of transgenic
seed containing a gene for antibiotic resistance had been shipped from the
United States to Europe to have provoked a vigorous official response.

So far, however, reactions from Brussels have been equivocal. Markos
Kyprianou, the European commissioner responsible for health and consumer
protection, started strongly, declaring that he "deplores" the inadvertent
release of unapproved seed in the European Union (EU). But since then, his
spokesman has sent mixed messages. First, he simply expressed confidence in
the ongoing US investigation into the incident; only later did he state that
the European Commission is itself vigorously demanding more information from
the company responsible about what happened.

The spokesman's second statement is appropriate; the first seems inadequate.
This incident points to fundamental problems with the regulatory framework
for agricultural biotechnology in the United States. And the response of
the agencies involved gives little confidence that these problems are being
seriously addressed.

The facts of the case are these: from 2001 until late last year, a US
subsidiary of the Swiss firm Syngenta allowed American farmers to plant
15,000 hectares of corn, or maize, that had been modified with an
unapproved version of a gene from the soil bacterium Bacillus thuringiensis
that codes for an insecticidal protein (see Nature 434, 423; 2005). Small
batches of the unapproved seed were also exported to Europe.

After Nature revealed this mistake, Syngenta claimed that there was no
significant difference between the approved genetically modified corn,
called Bt11, and the corn that had been inadvertently released, called
Bt10. Only later did the company admit that Bt10 differs from Bt11 in that
it contains an additional gene that confers resistance to the antibiotic
ampicillin (see Nature 434, 548; 2005) a difference that most experts agree
is of some significance.

System error

Some scientists are shocked that this oversight could have been allowed to
persist for so long without detection. One might think that the US federal
government, a long-standing champion of agricultural biotechnology, would
be hopping mad about the mistake, and keen to get the facts out to satisfy
sceptics around the world that it now has the situation firmly under

Think again. The US regulatory system divides responsibility between three
different agencies, which have collectively failed to respond adequately to
this incident. Under a framework introduced during the administration of
President Ronald Reagan in the 1980s, the US Department of Agriculture
(USDA), the Food and Drug Administration (FDA) and the Environmental
Protection Agency (EPA) between them share responsibility for the approval
and monitoring of genetically modified crops.

Broadly speaking, the USDA checks to see whether a transgene should be
regarded as an agricultural 'pest'; the EPA considers the safety of
proteins that can act as pesticides, such as the bacterial toxins expressed
by Bt10 and Bt11; and the FDA is responsible for regulating other food
safety aspects of transgenic crops.

The FDA has some justification in taking a back seat in the US
investigation, noting that the toxin in Bt10, as a pesticide, falls outside
its jurisdiction, and judging - quite reasonably - that the
antibacterial-resistance gene in Bt10 does not represent a food safety

The USDA, meanwhile, sees itself primarily as a promoter of US agriculture
and related commercial interests a self-image that has so far been
reflected in its handling of this case. Its press office could be taking
its line straight from Syngenta: "The system is working," a departmental
spokesman said late last month of a process that has taken four years to
unearth the cultivation of an unapproved crop. Using the time-honoured
technique for burying uncomfortable information, the USDA chose to release
news of its decision to fine Syngenta $375,000 for its error on a Friday

Root cause That leaves the onus on the EPA to investigate the matter. In
theory, it has the technical expertise and the legislative authority that
it needs to function effectively. But in practice, the EPA's efforts in
regulating transgenic crops are mostly devoted to premarketing approvals.
According to well-informed critics, the agency has few resources to devote
to the Bt10 investigation. This does little to dispel the message of a
story carried on 23 March by the satirical website The Onion
(, which suggested that the EPA had announced that
it would henceforth be known as The Agency. "We're not really
'environmental' anymore, and we certainly aren't 'protecting' anything,"
read a quote mischievously attributed to an agency official.

Given the state of the US investigation, the European Commission should
establish the relevant facts to its own satisfaction. Syngenta, after all,
is a European company - albeit one with headquarters in Switzerland, a
non-EU state not known for the transparency of its corporate sector. The
company should be forced to reveal how Bt10 got on to the market in the
first place, and why it then took four years to discover the mistake.

So far, we've heard nothing on the former, and Syngenta has attributed the
belated discovery of its inadvertent release of Bt10 to progress in the
technology that it uses to monitor seeds. If true, this explanation will
come as news to anyone who had assumed that the agricultural-biotechnology
industry had known from the start what transgenes it was putting into its
seeds. If the discovery was simply a matter of happenstance, we can have
little confidence that similar problems won't occur again.

Thankfully, on this occasion we're not dealing with a threat to public
health. But the incident will further undermine public confidence. Covering
up the circumstances of the current incident may in the short term make life
more comfortable for Syngenta and for the regulators who were supposed to
prevent the release of unapproved seed. But the long-term prospects for the
application of plant genetics would be better served by firm regulation and
a degree of candour that has so far been sadly lacking in the performance
of the main players in this case.

European NGO Network on Genetic Engineering

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

P: +49-531-5168746
F: +49-531-5168747
M: +49-162-1054755
E: coordination(at)
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