2.BASF: Further delay in Amflora approval process not acceptable
1.EU gets ready to test waters on GMO crop growing
By Jeremy Smith
Reuters, December 12 2008
BRUSSELS - Europe's environment chief has prepared draft authorisations for two biotech maize types to be grown in the European Union, testing the political climate of 27 countries that together are historically wary of biotechnology.
If EU governments agree to the approvals, it would represent the first authorisation to grow a GM crop in 10 years. While politically, that scenario still appears touch-and-go, Brussels is under a lot of pressure to move forward on GM crop approvals.
In an apparent U-turn in his attitude as one of EU executive's most GM-wary commissioners, environment chief Stavros Dimas has now written draft approvals for both the maize crops, EU and industry officials say.
But so far, the paperwork is being kept well under wraps, with Commission experts believed to be under firm instructions not to release it anywhere near the public domain.
In October 2007, Dimas wanted to block both GM applications and even drafted rejection notices to say it was too uncertain that growing the biotech crops would not hurt the environment.
After intensive internal debates on GMO policy, coupled with the pressure of a court case brought by one of the manufacturing companies and a third "green light" report by EU food safety agency EFSA -- things may finally be moving at the Commission.
The crops are Bt-11 maize, engineered by Swiss agrochemicals company Syngenta, and 1507 maize -- jointly developed by Pioneer Hi-Bred International, a unit of DuPont Co and Dow AgroSciences unit Mycogen Seeds.
GAME OF PING-PONG?
In Europe, consumers are well known for their scepticism, if not hostility, to GM crops, often called "Frankenstein foods."
But the biotech industry insists its products are as safe as conventional equivalents. After hefty investments and years of research, it is frustrated over what it sees as the EU's delay in approving GM products to deny it access to European markets.
Pioneer is a case in point. Last year it filed a lawsuit against the Commission for what it says are undue delays in processing its request for EU approval for growing 1507 maize, submitted seven years ago. Six countries have now approved this product for cultivation, Brazil being the latest this week.
An EU public hearing for the case was held in mid-November.
"In court, the Commission committed to submit a proposal for approval taking into account the third positive opinion from EFSA and to submit this to member states in January with a decision expected in February 2009," said Mike Hall, Pioneer's communications manager for Europe.
"We expect nothing less than immediate action on behalf of the Commission," he said. "We've met all the obligations under EU legislation and have played this game of ping-pong long enough -- the ball is now with the Commission and member states to meet their obligations to approve a safe product," he said.
The same scenario is expected for Syngenta's application, officials say -- although whether EU countries can muster the necessary majority in February to approve the applications under the bloc's weighted voting system remains to be seen.
The European Union has long been split on GMO policy and its 27 member states consistently clash over whether to approve new varieties for import -- but without ever reaching a conclusion.
Some countries, like Britain, Finland and the Netherlands, almost always vote in favour of approving new GMOs. They are offset by a group of GMO-sceptic states like Austria, Greece and Luxembourg, that vote against and force a voting stalemate.
However, approving a new GMO crop for cultivation is seen as almost impossible in the EU's current climate, diplomats say.
More pressure on the Commission has come from German chemical company BASF, which filed a similar lawsuit last year over its GM Amflora high-starch potato -- the paperwork for which has sat on Dimas' desk since July 2007. (Editing by James Jukwey)
2.BASF: Further delay in Amflora approval process not acceptable
BASF press release, 10 December 2008
*All scientific evidence shows that Amflora, BASF's genetically modified potato, is safe
*Approval delay rules out commercial cultivation in 2009, depriving European farmers and potato starch industry of â‚¬100-200 million in income per year
*Lack of progress confirms the necessity of legal action against the EU Commission
Limburgerhof , Germany - December 10, 2008 - Today, the European Food Safety Authority (EFSA) released information stating it will not complete its opinion on nptII, a marker gene used in the starch potato Amflora, by December 15 as previously announced. The EU Commission has granted EFSA a second extension to March 31, 2009. “This delay means that commercial cultivation of Amflora will not be possible in 2009 and will deprive European farmers and the potato starch industry of â‚¬100-200 million in income,” said Dr. Stefan Marcinowski, member of the Board of Executive Directors of BASF SE. “There is no scientific evidence that questions the safety of Amflora. The continuous delay can only be explained by EU Commissioners’ political motivations dominating the approval process. This indicates that BASF was right to initiate legal action against the EU Commission for failure to act in July this year.”
After its orientation debate on genetically modified organisms in May, the EU Commission again did not approve Amflora but decided to ask EFSA for a fifth safety assessment that concerns Amflora. The focus of the assessment is the nptII marker gene used in a number of genetically modified plants, including Amflora. At the same time, the Commission announced that it would approve Amflora “if and when” the marker gene would again be evaluated safe. The initial deadline for the opinion, September 30, 2008, was already extended to December 15 earlier this year.
BASF is determined to continue the approval process and expects EFSA to confirm its four earlier assessments, stating that Amflora and its genetic marker are safe for humans, animals, and the environment since there is no new scientific evidence questioning earlier assessments.
“If the Commission is serious about supporting our fragile economy, it should promote promising technologies such as plant biotechnology that make Europe more competitive,” continued Marcinowski. “Instead, it is forcing companies through more than 12 year long approval processes. We expect the market for genetically modified crops to be worth $50 billion per year by 2025. If Europe continues to ignore the vast scientific evidence that says the technology is safe, other continents will benefit from this booming sector.”
About the nptII genetic marker
The marker with the scientific name ‘nptII’ is used in plant biotechnology laboratories during the very first stage of development. Genes responsible for desired plant traits are coupled with a marker, for instance a gene conferring resistance to antibiotics. When an antibiotic is applied on plant sprouts the unchanged plants wither, whilst the plant with the desired traits, coupled to the marker, are unaffected. In the lab, plants with and without the added, desired traits can thus be distinguished from each other.
According to EFSA, the likelihood of antibiotic resistance to spread due to the use of marker genes is negligible and can be ignored: the needed transfer of resistance from plant cells to bacteria has never been observed in nature. Also, EFSA stated in previous opinions that exactly the same resistance to antibiotics and the corresponding resistant genes are already widespread in bacteria.
The Amflora approval process to date:
* The Amflora approval process was initiated more than 12 years ago with the request for authorization submitted in August 1996. The scope of the application included cultivation, industrial use and feed.
* During the moratorium on genetically modified products between 1998 and 2004, no approvals for genetically modified plants where granted in the EU.
* BASF Plant Science resubmitted a dossier for cultivation and a dossier for food and feed use in 2003 and 2005, respectively, due to modified EU regulations.
* In 2006, the EU Commission published two EFSA assessments that for both dossiers concluded that Amflora is as safe for humans, animals and the environment as any conventional potato.
* In November 2006, Commissioner Dimas forwarded his proposal for authorization of cultivation of Amflora to the Regulatory Committee consisting of representatives from all EU Member States.
* After two inconclusive votes in the Regulatory Committee in December 2006 and the Council of Agricultural Ministers in July 2007, Commissioner Dimas failed to adhere to the approval procedure defined by EU legislation and to adopt the proposal for cultivation.
* On September 21, 2007, Commissioner Dimas answered upon questions by Green MEP Breyer (WRITTEN QUESTION P-4070/07 by Hiltrud Breyer [ Verts/ALE]) to the Commission that Amflora is safe.
* The dossier for food and feed use was voted upon in the Standing Committee - consisting of members from all member states - in October 2007 and Council of Agricultural Ministers in February 2008. According to the defined EU approval procedure, the Commission has been responsible for adopting the proposal since February 2008.
* BASF expressed its dissatisfaction with Commissioner Dimas’ handling of the approval process in an open letter to Commissioner Dimas on April 17, 2008.
* In its “orientation debate” on genetically modified plants on May 7, 2008, the Commission decided to request EFSA to prepare a new consolidated scientific opinion on the use of antibiotic resistance marker genes in genetically modified plants by September 30, 2008. Such a marker gene is also used in Amflora.
* In a press release following the debate, Commission President Barroso stated that Amflora will be approved “if and when” EFSA confirms the safety of antibiotic resistance marker genes.
* On May 19 2008, BASF Plant Science formally requested access to any documents in the possession of the EU Commission in connection with the authorization procedure for Amflora. These documents did not reveal any new scientific evidence regarding the safety of Amflora.
* On July 24 2008, one year after the vote in the Agricultural Council (the last formal step prior to adoption of a decision), BASF Plant Science filed an action with the European Court of First Instance against the EU Commission for failure to act.
* EFSA responded in autumn 2008 that its opinion on antibiotic resistance marker genes will not be finalized until December 15, 2008.
About BASF Plant Science
BASF - the Chemical Company - consolidated its plant biotechnology activities in BASF Plant Science in 1998. Today, about 700 employees are working to optimize crops for more efficient agriculture, renewable raw materials and healthier nutrition. Projects include yield increase in staple crops, higher content of Omega-3s in oil crops for preventing cardiovascular diseases, and potatoes with optimized starch composition for industrial use.
To find out more about BASF Plant Science, please visit www.basf.com/plantscience.
BASF is the world’s leading chemical company: The Chemical Company. BASF has more than 95 ,000 employees and posted sales of almost â‚¬58 billion in 2007.
Further information on BASF is available on the Internet at www.basf.com