2-Plants: EU Environmental Council blocks GE maize NK603 approval

[GENET <coordination@genet-info.org>]

-------------------------------- GENET-news -------------------------------

TITLE:  Commission fails to get Monsanto's GM maize NK 603 approved
SOURCE: Friends of the Earth Europe
        http://www.foeeurope.org/press/2004/GR_28_june_maize_NK603.htm
DATE:   28 Jun 2004 

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Commission fails to get Monsanto's GM maize NK 603 approved

Brussels, Luxembourg, 28 June. Today, EU environment ministers did not
manage to reach an agreement on a proposal by the European Commission to
authorise the import of genetically modified maize NK 603, produced by
the US company Monsanto. 9 EU ministers (from Austria, Cyprus, Denmark,
Greece, Hungary, Italy, Malta, Lithuania and Luxembourg) voted against
the proposal and 5 countries (Belgium, Germany, Spain, Slovakia and
Slovenia) abstained. 11 countries (Czech Republic, Estonia, Finland,
France, Ireland, Netherlands, Latvia, Poland, Portugal, Sweden and UK)
voted in favour.

Geert Ritsema, GMO campaign coordinator for Friends of the Earth Europe said:

"This is the 6th time in a row that the European Commission fails to
convince the member states to approve a GMO (1). The Commission wants to
show the public that there is a thorough safety assessment for any
adverse impact on public health. What they achieve is the contrary. It is
becoming more and more visible that the authorities in Europe are deeply
divided over GMOs."

Friends of the Earth last week urged the environment ministers to reject
Monsanto's GM maize, since:
- There has only been an analysis of the short term effects on human and
animal health. There has been no analysis of the long term effects on
subsequent generations and the effects on health sensitive consumers.

This is in breach with article 14 of EU Regulation 178/2002.
- There has been insufficient analysis of allergenicity. It is
unacceptable that EFSA has dismissed the legitimate concerns raised by
several Member States, about the suitability of the approach used for
allerginicity testing. (2)

The next vote on maize NK 603 will be by the EU farm ministers.
Monsanto's application for the import of NK 603 maize is split in two.
Today's vote was on the import for animal feed, the farm ministers will
vote within 3 months about the use of NK 603 in food. If the farm
ministers fail to agree, it is up to the Commission to decide whether the
import of NK 603 maize will be allowed without the support of the member
states.

Contact:
Geert Ritsema, phone: +31-6-290 05 908

Footnotes:

(1) Votes on GMO approvals by member states

8 December 2003
Vote on BT11 at the Standing Committee on Food and Chain and Animal Health
Result: no qualified majority (qm)
{in favour ES, IE, NL, FI, SW, UK; against: DK, GR, FR, LU, AT, PT;
abstentions BE, DE, IT}

18 February 2004
Vote on NK 603 (C/ES/00/01) for import and use in feed and industrial
processing at the Standing Committee of Release of GMOs into the Environment
Result: no qm
{in favour ES, BE, FI, FR, IT, NL PT, SW, UK; against: LU, AT, DK, GR,
IT, Abstention DE}

26 April
Vote on BT11 at the Council of Agriculture
Result: no qm
{in favour: IE, NL, FI, SW, UK, IT; against: DK, GR, FR, LU, AT, PT,
abstentions : BE, DE, ES}

30 April
Vote on NK 603 (NL 13/08/2002) for food. at the Standing Committee on
Food and Chain and Animal Health
Result: no qm
{in favour IT, IE, NL, FI, SW, UK, FR, BE; against: DK, GR, FR, AT, PT,
abstentions ES, DE }

16 June
Vote on GT 73 for import and use in feed and industrial processing at the
Standing Committee of Release of GMOs into the Environment
Results: no qm
{in favour: BE, CZ, FI, FR, NL. LV, PT, SK, SW, against: AT, CY, DK, EE,
GR, HU, IT, MT, LT, LU, PL, UK, abstentions: DE, IE, ES, SI)

28 June
Vote on NK 603 (C/ES/00/01) for import and use in feed and industrial
processing at the council of Environment Ministers

(2) For a detailed FoEE briefing on genetically modifeid maize NK 603, see
http://www.foeeurope.org/GMOs/pending/nk603briefing.pdf


Friends of the Earth Europe campaigns for sustainable and fair societies
and for the protection of the environment, unites more than 30 national
organisations with thousands of local groups and is part of the world's
largest grassroots environmental network, Friends of the Earth International.


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

TITLE:  Environment Council blocks GMO approval
SOURCE: Greenpeace European Unit, Press Release
DATE:   28 Jun 2004 

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Environment Council blocks GMO approval

Brussels, 28 June 2004-- The European Commission failed today to get EU
member state approval for a new GMO import into Europe. Greenpeace
expects the Commission to now disregard the lack of support from Member
States and approve the application, just as it did with Syngenta's Bt11
canned sweet corn one month ago.

"There is clearly no majority backing for GMOs among EU governments or
the public, yet the Commission persists in trying to impose them," said
Eric Gall of Greenpeace. "Those countries who rejected today's
authorisation are standing up against inadequate testing procedures and
patchy applications. They are also refusing to make life easy for the
Commission in its attempts to appease the Bush administration and its
business cronies."

EU environment ministers meeting in Luxembourg gave no qualified majority
to authorise Monsanto's NK603 maize, which has been modified to tolerate
Monsanto's Roundup herbicide.

Greenpeace has repeatedly criticised the inadequacy of evaluation
procedures, and the European Food Safety Authority's (EFSA) assessment of
NK603 [1], in which it overlooked the following scientific concerns in
the application:

- Unintended fragments in NK603 appear to be functional but were not
evaluated. By itself, this should render this GE product unsafe.

- Significant differences were noted between NK603 and its conventional
counterpart. Instead of being investigated further, these differences
were dismissed as "not of biological significance".

Greenpeace insists that no GMO should be authorised as long as there is
no EU-wide liability regime to protect farmers in the event of crop
contamination or for environmental damage. It notes that consumers are
still not informed about GMOs in animal feed, as there is no labelling
requirement for dairy and animal products at the point of sale.

Contact Eric Gall, Greenpeace European Unit, tel +32 (0)496 161 582


Notes 

1. Greenpeace scientific objections and comments on Monsanto's NK603
application:
http://eu.greenpeace.org/downloads/gmo/GPCommentsOnNK603.pdf
http://eu.greenpeace.org/downloads/gmo/GPTechCritOnNK603.pdf

See also Greenpeace critique of EFSA:
http://eu.greenpeace.org/downloads/gmo/CritiqueOnEFSA-April2004.pdf


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

TITLE:  EU Officials Deadlocked Over Biotech Corn
SOURCE: Associated Press
        http://news.yahoo.com/news?tmpl=story&u=/ap/20040628/ap_on_sc/
        eu_biotech_corn_1
DATE:   28 Jun 2004

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EU Officials Deadlocked Over Biotech Corn

BRUSSELS, Belgium - European Union governments on Monday failed to agree
on a contentious proposal to approve a genetically modified corn made by
a U.S. company for use in processed food.

Diplomats said EU environment ministers meeting in Luxembourg were
deadlocked in a vote on giving approval to the introduction of the corn
product, known as NK603, from Monsanto Co. of St. Louis.

Nine EU countries -- Latvia, Denmark, Cyprus, Hungary, Malta, Italy,
Greece, Austria and Luxembourg -- voted against the license, and two
countries, Belgium and Spain, abstained.

Nine others, led by Britain and the Netherlands were for approval.

[GENET/HM: This information is obviously wrong, the EU has 25 Member
States, correct data see FoEE press release] 

The stalemate, however, will not prevent the EU's head office from
approving the corn for sale on the European market. That decision is
expected in the next few weeks, officials said.

The European Commission urged EU governments last Friday to approve the
corn hybrid after it underwent "a thorough safety assessment for any
adverse impact on public health."

The union last month lifted its six-year moratorium on approving
genetically modified organisms. Under EU rules, member states have three
months to decide whether to accept requests for biotech products for sale
in the EU. If they fail to reach a decision, it is left to the Commission
to decide on the application.

The stalemate reflects the deep divisions in Europe over the use of
biotech foods.

Genetically altered crops remain unpopular among many consumers in the
wake of recent food-related health scares, from mad cow disease to
poisoned poultry.

In May, a biotech variety of corn made by Switzerland's Syngenta AG was
approved for import and sale, but not cultivation. It was the first such
approval for a biotech product in the EU since 1998, when a de facto
moratorium was imposed in response to public fears about the health and
safety of bioengineering.

The U.S. administration has accused the EU of violating international
trade rules by hindering the marketing of genetically modified food.
Although it has welcomed the EU's lifting of a moratorium, it continues
with a complaint against Europe at the World Trade Organization. An
initial ruling is expected in September.

In afternoon trading on the New York Stock Exchange, Monsanto shares were
up 71 cents at USD 36.19.


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

TITLE:  GM Canola safety assessments
SOURCE: Food Standards Australia New Zealand
        http://www.foodstandards.gov.au/mediareleasespublications/
        factsheets/factsheets2004/gmcanolasafetyassess2498.cfm
DATE:   28 Jun 2004 

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GM Canola safety assessments

SUMMARY

Suggestions that Europe has rejected import of the genetically modified
herbicide tolerant oilseed rape GT73 (known in Australia as Roundup Ready
canola) are wrong.

- The UK Advisory Committee on Releases to the Environment (ACRE) did not
reject the import and processing of the GT73 oilseed rape. ACRE was
satisfied with safety aspects but requested additional information,
including more data on DNA sequences, likely places of import/processing,
animal feed studies and monitoring measures. 

- Both ACRE and the European Food Safety Agency (EFSA) have evaluated the
oilseed rape and found it as safe as other approved imported oilseed rape.

- However, the relevant European Regulatory Committee was not able to
come to a clear decision on 16 June 2004, to approve the use of the
oilseed rape for feed and food use. It was therefore referred to the
European Council of Ministers for consideration.

- The Council of Ministers must act within three months. If the Council
neither adopts nor rejects the Draft Decision, it will return to the
European Commission which is then authorised to decide on its own authority.

- Media releases also suggest that Australian agencies have not
considered European reports on the safety of canola, particularly issues
relating to changed liver weight in rats.

- The suggestion that Australian agencies have failed to consider these
issues is not correct.

- The Gene Technology Regulator and Food Standards Australia New Zealand
(FSANZ) both examined the issue of increased liver weight in rats in
considerable detail during the evaluation of Roundup Ready canola and
concluded that there were no human health and safety concerns in relation
to the feeding studies in rats fed on canola meal.

- It should also be noted that canola meal is not consumed by humans and
is used as an animal feed. Only the highly refined oil from GM canola is
approved by FSANZ to enter the Australian food supply.

- The New Zealand Ministry of Health and the New Zealand Institute of
Environmental Science and Research, the South Australian Department of
Human Services, regulators in Japan, the USA, UK, Canada, and members of
FSANZ's panel of independent experts were also satisfied with this evaluation

 BACKGROUND

Health and safety findings - feed studies on rats

Comments in media releases relate to a feeding study in which there was a
small increase in liver weights in rats fed a diet of GM (glyphosate
tolerant) canola meal. Three rat feeding studies were provided by the
applicant to regulatory authorities for assessment.

The first study used unprocessed and processed canola meal, and showed no
differences of any significance in liver weights between the GM canola
and the non-GM parent line, although a minor difference in the group mean
body weight for male rats was observed. However, the seed used in this
study was found to be mixed with another GM line that was not under
assessment, and therefore was not a valid test of the GT73 line being
assessed.

The second study used only processed canola meal. This study showed a
slight increase in liver weights compared to the control, at the highest
dietary intake level (15%), but not at the lower level of intake (5%).
However, it was noted that the processing of the canola seed from the GM
and non-GM control lines was performed at a different time and place, and
consequently there were differences in the extent of processing of the
canola meal.

The third study was an assessment of the GM (GT73) canola meal, non-GM
control lines from around the world, and rat chow as a negative control.
On this occasion, all seed samples from the GM and non-GM lines were
processed at the same time, and to the same extent. There were no
significant differences in body weight, cumulative weight gain, terminal
body weights or food consumption for animals fed GM canola meal compared
to the non-GM control canola meal. Most importantly, there were also no
significant differences in absolute or relative liver or kidney weights
between animals fed the GM canola meal compared to the non-GM canola
meal, or the population of canola varieties.


Discussion of the results

FSANZ points out in the safety assessment of foods derived from GM canola
(see FSANZ website www.foodstandards.gov.au) that approval applies only
to the oil from glyphosate-tolerant canola. Canola meal is not normally
considered to be a human food fraction due to the presence of natural
toxicants (e.g. glucosinolates). The feeding studies using canola meal
were evaluated to compare levels of major components, and any potential
unintended effects.

All rapeseed contains natural toxins (such as glucosinolates in the seed
meal, and erucic acid in the oil) which are strictly regulated by canola
industry standards to very low levels. Canola oil is a highly processed
food in which glucosinolates are not present.

Although liver weights were increased in rats fed GM canola meal, this
difference was considered to be due to variation in the degree of
processing of the GM and non-GM canola seed used in the second study,
leading to differences in the levels of glucosinolates in the meal
fraction. Glucosinolates are well known to cause liver enlargement
(Hayes, Principles and Methods of Toxicology, 3rd Edition). Equally, and
perhaps more likely, the slight increases in liver weight were due to
chance, as there were no other behavioural or physiological differences
detected.

FSANZ scientists, the New Zealand Ministry of Health and the New Zealand
Institute of Environmental Science and Research, the South Australian
Department of Human Services, regulators in Japan, USA, UK and Canada,
and members of FSANZ's panel of independent experts were satisfied with
this evaluation. FSANZ concluded that there were no human health and
safety concerns in relation to the feeding studies in rats fed on canola meal.

It should be noted that canola oil itself cannot be fed to rats in
sufficient quantities to test for adverse effects because this would
cause malnutrition and other physiological imbalances. Thus no meaningful
information would result from this testing. Using canola meal in feeding
studies provides a test for more compounds than are present in oil and is
essentially a worst-case scenario. In feeding studies testing GT73 canola
seeds on other animals, no adverse effects were observed.

The Gene Technology Regulator's Risk Assessment and Risk Management Plan
for Roundup Ready canola also considered the issue of liver weight in
rats in considerable detail. This assessment is publicly available on the
Gene Technology Regulator's website at www.ogtr.gov.au/rtf/ir/
dir020finalrarmp.rtf.


European decision making process

On 23 September 2003 the UK Advisory Committee on Releases to the
Environment (ACRE) notified its response to an application for import of
genetically modified GT73 herbicide tolerant rapeseed into the European
Community and use for processing for food and feed (but not cultivation).

ACRE advised that the risks posed by GT73 were "no different from that of
other oilseed rape imported for processing and animal feed purposes".
ACRE also requested additional information on DNA sequence, likely places
of import/processing, animal feed studies and monitoring measures.

On 11 February 2004 the European Food Safety Authority (EFSA) Scientific
Panel on Genetically Modified Organisms concluded 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'. The Panel considered the increase
in liver weights as an incidental finding, similar to all other
regulators that have approved this GM canola.

After a GMO application receives a positive safety assessment from the
EFSA, a 'Draft Decision' is sent for approval to the appropriate
Regulatory Committee (in this case under the Committee covered by
Directive 2001/18/EC). The Committee comprises representatives of Member
State. To approve an application, a qualified majority of votes (88 out
of 124) in favour of the application is needed. Member States' votes are
weighted on the basis of their population and corrected in favour of
less-populated countries.

Following a vote in the Regulatory Committee (on 16 June 2004) on the
release of genetically modified organisms into the environment, the
decision to authorise the import and processing of the genetically
modified oilseed rape known as GT73 will pass on to the Council of
Ministers. The Committee, which is set up under Directive 2001/18 and
representing the Member States, did not reach the qualified majority
necessary to support the Commission proposal to authorise the oilseed rape.

The European Commission will now, in the coming weeks, formally adopt the
proposal to be sent to the Council of Ministers. The Council can either
adopt or reject the proposal with a qualified majority. If no decision is
taken after three months, the file returns to the Commission which can
then adopt it. If authorised, the oilseed rape, which has been modified
for increased tolerance to the herbicide glyphosate, would be clearly
labelled as containing GM oilseed rape, in accordance with the new
legislation in force since 18 April 2004.




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European NGO Network on Genetic Engineering

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