BASF: Further Delay in Amflora Approval Process Not Acceptable

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.

11/12/08 The European Food Safety Authority (EFSA) has 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 €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.”
 
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.